4Q2012EXCEL DMF# 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 STATUS Type SUBMIT DATE I I I I I I I I A I I I I I N I I I I I I I I I I I I N I I I I I I I I II II 9/3/1946 12/26/1946 5/22/1947 10/13/1946 12/12/1946 1/1/1947 12/13/1946 2/11/1947 II II II 6/1/1946

9/1/1947 1/1/1940 8/22/1946 1/1/1940 7/25/1946 11/3/1947 7/30/1946 6/2/1946 3/22/1946 9/12/1946 1/1/1946 II II IV II III II 2/8/1981 11/4/1947 5/8/1943 5/13/1943 6/5/1943 1/1/1940 4/9/1943 6/19/1943 1/1/1950 2/20/1944 2/23/1944 3/12/1944 2/21/1947 1/1/1945 HOLDER HEXCEL CHEMICAL PRODUCTS ROHM AND HAAS CO MONSANTO CHEM CO DIV MONSANTO CO NIACET CORP SUBJECT CPC LETHANE 384 SPECIAL SUCCINYL SULFATHIAZOLE SUCROSE OCTA ACETATE

4Q2012

CALCO CHEM CO DIV AMERICAN CYANAMID N' BUTYRYL SULFANILAMIDE SODIUM-N' BUTYRYL SULFANILAMIDE CO NATIONAL RESEARCH COUNCIL PENICILLIN FRIES BROS INC WF STRAUB & CO EASTMAN CHEMICAL CO NATIONAL RESEARCH COUNCIL HERCULES POWDER CO ROHM AND HAAS CO NATIONAL RESEARCH COUNCIL YEAST PRODS INC NOT AN ASSIGNED NUMBER FLUORDENT INC VETERANS ADMINISTRATION PENICK CORP FRIES BROS INC FLUORIDES STREPTOMYCIN TYROTHRICIN DESOXYEPHEDRINE META HOMO MENTHOL HEXESTROL C-A-P(TM) CELLULOSE ESTER, NF GELATIN & OTHER BLOOD SUBSTITUTES SODIUM CARBOXYMETHYLCELLULOSE HYAMINE X (QUATERNARY AMMONIUM CHLORIDE COMPOUND) BAL IN OIL RIBOFLAVIN, ACETYLATED

ABBOTT LABORATORIES PHARMACEUTICAL THIOURACIL PRODUCTS DIV SMITH KLINE & FRENCH LABS DIV CARBOXYMETHYLCELLULOSE SMITHKLINE BECKMAN CORP MERCK AND CO INC NITROGEN MUSTARDS DEPT OF DEFENSE-ARMY LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO JOHNS HOPKINS HOSPITAL PROTEIN HYDROLYSATES STERILE FILLED PHARMACEUTICAL PREPARATIONS P-ARSENOSOPHENYLBUTYRIC ACID

ABBOTT LABORATORIES PHARMACEUTICAL VITAMIN K, HYKIMONE (ABBOTT) PRODUCTS DIV CINBERG B L MD PROGESTERONE NOT AN ASSIGNED NUMBER BOOTS FLINT INC SUB BOOTS CO USA INC NATIONAL RESEARCH COUNCIL NEW YORK QUININE & CHEMICAL WORKS INC STEPAN CO INC SB PENICK AND CO ORIG AMINO ACIDS SN 13,276; PALUDRINE (CHLORUGUAN); SN 12-837 METOPON B.T.C.(ACTIVE INGRED: BENZALKONIUM CHL) RUTIN

UNIVERSITY OF CHICAGO DEPARTMENT OF CARBOWAX--POLYETHYLENE GLYCOLS & OTHER GLYCOLS MEDICINE NATL INST HLTH CLINCL CTR PHARMACY PALUDRINE PARKE DAVIS & CO ANTIMALARIAL SN 10751

Page 1

4Q2012EXCEL DMF# 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 STATUS Type SUBMIT DATE I I I I I I I I I I I I I I N I I N I I N I I I I I I I I I I N I I I I I I II II 3/22/1951 1/1/1940 6/11/1951 6/27/1951 7/19/1951 7/31/1951 II II 1/1/1950 9/16/1963 1/31/1967 3/5/1951 3/9/1951 1/1/1951 1/1/1940 4/27/1950 1/1/1940 1/20/1950 3/9/1950 9/20/1949 10/17/1949 II II II 4/17/1947 3/7/1947 8/2/1946 6/6/1947 10/21/1947 10/1/1947 10/29/1947 1/16/1947 12/19/1947 2/12/1948 2/9/1948 12/23/1947 3/26/1948 9/10/1963 HOLDER UNIVERSITY OF MINNESOTA GIVAUDAN-DELAWANNA INC US ATOMIC ENERGY COMMISSION DR. KARL JOHN KARNAKY WISC ALUMNI RES FDTN JOHNS HOPKINS HOSPITAL SCHERING CORP SUB SCHERING PLOUGH CORP US PUBLIC HEALTH SERV ICI AMERICAS INC USPHS HOSPITAL BATTELLE MEMORIAL INSTITUTE ENDO PRODS INC LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO ROHM AND HAAS CO NOT AN ASSIGNED NUMBER SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP SCHENLEY LABS INC NOT AN ASSIGNED NUMBER WYETH INC SNYDER AND SNYDER NOT AN ASSIGNED NUMBER HEYDEN CHEM CORP ENDO PRODS INC PENICK CORP FIRMENICH INC ROHM AND HAAS CO AMERICAN CYANAMID CO NATL INST HLTH CLINCL CTR PHARMACY LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO DEPT AGRICULTURE COMMERCIAL SOLVENTS CORP NOT AN ASSIGNED NUMBER UNITED STATES PHARMACOPEIA CHAS PFIZER AND CO INC SB PENICK AND CO ORIG INTERNATL HORMONES INC METAL & THERMIT CORP PACIFIC YEAST PRODUCTS INC ACTH POLYMYXIN CASANTHRANOL AQUEOUS MICROSUSPENSION OF HORMONES DIBUTYL TIN DILAURATE B 12 SSUPPLEMENT (B-MEGAHERIUM) SOLPROTEX (DIGALLOYL TRIOLEATE) RESINS - ION EXCHANGE AMBERLITE IRP 276 (CHOLESTYRAMINE RESIN USP) DIOCTYL SODIUM SULFOSUCCINATE LEVO-ISO-METHADONE GENERAL METHODS OF ASSAY AND CONTROLS STARCH SPONGE DEXTRAN(DWAS DISCN 7.31.51) MADE PAET OF NDA 8008 P.A.S. (PARA-AMINOSALICYLIC ACID & SODIUM PARA-AMINOSALICYLATE ) MANIBEE-C-FORTE ARTISONE ACETATE ANTIHISTAMINE INSOMNIA TREAMENT (MISCELLANEOUS) KELLIN--TOXICITY STUDIES CONTEBEN SUBJECT AMIDONE, DOLPHINE, (4,4-DIPHENYL-6-DIMETHYLAMINO-3-HEPTANONE HCL) DIBENAMINE RADIO ISOTOPES STILBESTROL, INJ. & TABLETS MOHIS CANCER PASTE; ZINC CHLORIDE FIXAIVE THE ADMINISTRATION OF DI-ISOPROPYL FLUOROPHOSPHATE (DFP) TO MAN ANTIHISTAMINICS VIRUS, THERAPEUTIC SERUM, TOXIN ANTITOXIN

4Q2012

SORBITOL, MANITOL, HEXITOL EMULSIF. AGENT-TN: SPAN; TWEENS; ARLACEL ISOMETHADON SELENIUM SULFIDE ENCODOL (DIHYDROHYDROXY CODEINONE) LEDINAC PARENTERAL AMBERLITES IRC-50 & XE 64

Page 2

4Q2012EXCEL DMF# 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 STATUS Type SUBMIT DATE I I A I A I I I I I I I I I I I I I I I I I I N I N A I I I I I I I I I I N I 5/21/1953 II II II IV 6/2/1965 8/26/1952 10/29/1952 9/16/1952 1/1/1940 1/1/1940 2/3/1953 12/16/1952 3/18/1953 5/28/1953 5/29/1953 1/1/1940 II II II IV 9/8/1966 7/16/1951 10/18/1951 8/11/1950 1/31/1952 1/1/1940 1/1/1940 1/1/1940 1/1/1940 2/25/1952 1/1/1940 4/4/1979 3/4/1954 3/25/1952 5/9/1952 6/23/1952 5/19/1952 1/1/1940 9/22/1952 IV 7/30/1951 7/31/1951 3/10/1950 HOLDER PERMUTIT CO SB PENICK AND CO ORIG DOW CHEMICAL CO SCHERING CORPORATION INTERNATIONAL SPECIALTY PRODUCTS MAYO CLINIC DIAMOND SHAMROCK CHEM CORP NATIONAL STARCH & CHEMICAL CORP CHLORAMINT CO TRACER LAB INC NATIONAL RESEARCH COUNCIL HOFFMANN LA ROCHE INC DEPT OF DEFENSE-ARMY AMES CO DIV MILES LABS INC PLAVOLEX PLASDONE POLYVINYL PYRROLIDONE COMMITTEE ON SAFETY OF THERAPEUTIC AGENTS DIPHENYLPYRALINE(THIS DFORMERLY HELD BY NOPCO CHEM. CO) DRYFLO SUBJECT PERMUTIT Z-AMMONIUM; PERMUTIT Z P-POTASSIUM VERABORE--SPECIAL AMORPHOUS ALKALOIDS OF VERARUM VIRIDE METHOCEL HG --HYDROXYPROPYL METHYLCELLULOSE

4Q2012

O-SILVER ANTISEPTIC DISPOSABLE DIAPERS & ANTISEPTIC SURGICAL DRESSING RADIOACTIVE ISOTOPES (CONTAINS MEMO ON) PLASMA EXPANDERS TREAMENT FOR TB PRIMAQUINE N-ACETYL-PARAAMINOPHEMOL PLAVOLEX (PLASMA VOLUME EXPANDER)

ER SQUIBB & SONS PHARMACEUTICAL LABS NYDRAZID WORTHINGTON BIOCHEM CORP AMERICAN CHOLESTEROL PRODUCTS INC A MASCHMEIJER JR INC EI DUPONT DE NEMOURS AND CO NIPA LABORATORIES INC NEPERA CHEM CO MONSANTO CHEM CO DIV MONSANTO CO NOT AN ASSIGNED NUMBER PFIZER AND CO NOT AN ASSIGNED NUMBER BASF CORP PARKE DAVIS & CO GEORGE A BREON CO INC SB PENICK AND CO ORIG CHAS PFIZER AND CO INC NATL INST HLTH CLINCL CTR PHARMACY ROUSSEL CORPORATION DEXTRAN CORP NORDA ESSENTIAL OIL AND CHEM CO INC LLOYD BROS INC SB PENICK AND CO ORIG NOT AN ASSIGNED NUMBER TERRA CHEMICALS INC AEROSIL PLURONICS (L62 F68) L44 PLURONIS POLYOLS GENERAL METHODS OF MANUFACTURE $ CONTROL METHODS ,FACILITIES $ CONTROLS AQUEESTROL STREPTOMYCIN HYDRAZIDE ISONICOTINYL DARAPRIM (PYRIMETHAMINE) CORTISONE ACETATE PLASMA EXPANDERS DICHLOROSAN COBALT NEOMYCIN SULFATE USP LUDOX HYALURONIDASE AMERCHOL ISONICOTINIC ACID HYDROZIDE ALAHON (POLYTHENE RESIN) OTTAFECT AND OTTASEPT COMPOUND 1318 ACTAMER

Page 3

4Q2012EXCEL DMF# 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 STATUS Type SUBMIT DATE I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I II II II II I V II IV II II 6/23/1953 7/3/1953 7/5/1953 8/14/1953 9/11/1953 5/9/1952 9/21/1953 10/23/1953 11/18/1953 11/20/1953 10/20/1953 7/23/1953 1/20/1954 2/9/1954 2/1/1954 2/23/1954 1/27/1954 9/23/1953 1/1/1940 1/25/1954 2/10/1954 9/28/1953 5/20/1954 4/27/1954 5/26/1954 5/25/1954 1/1/1940 10/21/1947 10/6/1941 1/1/1940 7/2/1954 1/17/1977 7/14/1954 9/3/1954 9/2/1954 1/1/1940 9/15/1954 HOLDER CHATTEM CHEMS DIV CHATTANOOGA MEDICINE CO RT VANDERBILT CO SARATOGA TRADING CORP SB PENICK AND CO ORIG SUBJECT DIHYDROXY ALUMINUM-SODIUM CARBONATE VANCIDE 89 (CAPTAN) RAUWOLFIA SERPENTINA PROTAVERARINE

4Q2012

PASADENA RESEARCH LABORATORIES INC HYDROCORTISONE ACETATE ER SQUIBB & SONS H REISMAN CORP NEPERA CHEM CO NORDA ESSENTIAL OIL AND CHEM CO INC SB PENICK AND CO ORIG UNION CARBIDE AND CARBON CORP PFIZER AND CO MEER CORP DOW CORNING CORP WARWICK CHEM CO GENERAL ANILINE AND FILM CORP RK LAROS CO UNION CARBIDE AND CARBON CORP CENTRAL SOYA GIVAUDAN-DELAWANNA INC NATIONAL RESEARCH COUNCIL LIDD DAVID MD AMGER CHEMICALS INC SB PENICK AND CO ORIG DOW CHEMICAL CO MICHIGAN DIV NEPERA CHEM CO RG TAYLOR CO INC SE MASSENGILL CO-ORIG ORGANICHEM CORP BF GOODRICH COMPANY BF GOODRICH COMPANY US ATOMIC ENERGY COMMISSION CENTAUR CALDWELL DIV STERLING DRUG INC 3M PHARMS CHAS PFIZER AND CO INC IOWA STATE COLLEGE THOS LEEMING & CO SUB CHAS PFIZER & COMPANY INC VITAMINE B-12 EPOXYTROPINE TROPATE METHYLBROMIDE COMPOUND NO.1112 HALOSAN PHTHALAMAQUIN VINYLITE VAGH RESIN NEOMYCIN SULFATE CAPS (THIS DCHANGED TO NDA 9-579) RAUWOLFIA SERPENTINA SILICONES WARCO A-266 SODIUM N-LAUROYL SARCOSINATE FRUCTOSE LINDE SILICONE L-45 SOYBEAN STEROL PRODUCTS SUNSCREEN M.E.C. DRUG ADDICTION $ NARCOTICS POLYVINYL PYRROLIDONE DEHYDROACETIC ACID RESERPINE SHORT TERM CHRONIC DIETARY FEEDING OF METHOCEL 2602 TO RAS THONZONIUM BROMIDE A-THYMOXY-A-A-DICHLORACETIC ACID, A(1 METHYL-4-ISOPROPL-3-PHENOXY)-A-A FACILITIES $ CONTROL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. PARACHLORPHENOL MONOSULFIDE MONOBENZYL ETHER OF HYDROQUINONE RADIO ISOTOPES, IODINE 131 AND PHOSPHORUS 32 FACILITIES $ CONTROL VARIOUS RAUWOLFIA SPECIES RESERPINE DIETHYLSTILBESTROL AS A CATTLE FEED ADDITIVE FACILITIES ,CONTROL

Page 4

4Q2012EXCEL DMF# 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 STATUS Type SUBMIT DATE I I I A I I I I I I I I I I I I I I I I I I I I I I I I N I I I I A I I I I II II 10/28/1955 10/13/1955 1/1/1940 1/1/1940 2/29/1952 12/5/1955 12/22/1955 7/24/1956 1/11/1956 I II I IV II II IV II 1/1/1940 6/1/1955 10/1/1954 9/29/1954 4/25/1955 11/3/1954 11/4/1954 11/5/1954 11/9/1954 11/9/1954 1/1/1940 1/11/1955 1/27/1955 1/25/1955 2/1/1955 3/29/1955 2/25/1955 3/10/1958 1/1/1940 7/13/1955 6/15/1955 8/16/1955 8/18/1955 8/18/1955 6/14/1955 8/24/1955 1/1/1940 5/12/1955 HOLDER LLOYD BROS INC NATIONAL RESEARCH COUNCIL LUBRIZOL ADVANCED MATERIALS INC SB PENICK AND CO ORIG SUPRAMAR CHEMS MEER CORP GENERAL ELECTRIC CO MEER CORP CORN PRODS INC BF GOODRICH COMPANY ROUSSEL CORPORATION WORTHINGTON BIOCHEM CORP WEST DISINFECTING CO CF BOEHRING AND SOEHNE GMBH SUNKIST GROWERS CF BOEHRING AND SOEHNE GMBH LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO PENICK CORP MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC EASTMAN CHEMICAL CO NEW DRUG INSTITUTE CHEM SPECIALTIES CO INC CHEM SPECIALTIES CO INC CF BOEHRING AND SOEHNE GMBH MERCK AND CO INC NEW DRUG INSTITUTE STERO-KEMS CO NOT AN ASSIGNED NUMBER CITRUS & CANNED PRODUCTS ASSOCIATION NATIONAL RESEARCH COUNCIL NEW DRUG INSTITUTE WORTHINGTON BIOCHEM CORP INTERNATIONAL SPECIALTY PRODUCTS COLLETT-WEEK CORP ELI LILLY AND CO CHATTEM CHEMS DIV CHATTANOOGA MEDICINE CO NEW DRUG INSTITUTE HESPERDIN PLASTIC BAG CONTAINERS NDI FORMULA 200 DESOXYRIBONUCLEASE, PANCREAIC POLYVINYL PYRROLIDONE-IODINE 10 CRYSTALLINE RESERPINE FORM R. VOMITORIA TOPICAL ANESTHETIC COMPOUND C-10 TETRAHYDROXY DIALUMINUM MAGNESIUM DIGLUTAMATE NDI. FORMULA 156 SUBJECT COBALT NRC.MEETING $ OTHER MEETINGS CARBOPOL 934, 940NF, 910NF, AND 941NF RAUSERFIA TABLETS RESERPINE P.E. VERARUM, MEER 4-5% MIXED SILICONES RESERPINE CONCENTRATE GLUCURONO-LACTONE $ THE SALTS OF GLUCURONIC ACID DIPHENYL-P-PHENYLENEDIAMINE HYDROCORTISONE,FREE ALCOHOL CRYSTALLINE TRYPSIN WESCODYNE RESERPINE 100% PURE AIKALOID $ RAUWOLFIA SERPENTINA BENTH BIOFLAVONOIDS RESERPINE PURE ALKALOID $ RAUWOLFIA VOMITIORIA SPECIFICATIONS AND METHODS OF ASSAY UTERASE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. D-ALPHA-TOCOPHERYL POLYETHYLENE GLYCOL 1000 SUCCINATE RAUWOLFIA SERPERTINA WHOLE ROOT,MANNITOL HEXANITRATE , RESERPINE PURE CRYSTALLINE COMPOUND PRONAL (BULK) RESERPINE PURE CRYSTALLINE COMPOUND PRONA (BULK) RESERPINE OHIO AGRICULTURE EXPERIMENT STATION MASSIVE VIT D FOR MILK FEVER PREVENTION

4Q2012

PROCESS $ CONTROL DATE CONCERNING MANUFACTURE OF 2-ACETYLAMINA ETC. RESERPINE;PROTOVERARINES A&B;SUCROSE;STARCH;LACTOSE;ACACIA;MAGNESIUM RALUBEN

Page 5

4Q2012EXCEL DMF# 188 189 190 191 C 192 193 194 I 195 196 I 197 198 199 200 I 201 202 A 203 204 205 206 207 I 208 I 209 210 211 212 213 214 215 216 I 217 218 I 219 220 I I 12/8/1958 7/23/1956 I II 7/9/1956 1/1/1940 I I I I I I I II II II 5/23/1956 5/26/1959 1/1/1940 1/1/1940 7/13/1956 1/1/1940 5/21/1965 7/16/1956 I 5/24/1956 I N N I 4/30/1956 5/9/1956 II 1/1/1940 I II IV 1/1/1940 3/4/1964 I I I 5/2/1956 4/9/1956 1/1/1940 3/29/1956 I 3/8/1956 5/1/1956 I I 2/2/1956 2/17/1956 2/16/1956 STATUS Type SUBMIT DATE I I I II II 1/20/1956 1/1/1940 1/24/1956 1/24/1956 HOLDER WYETH INC SUBJECT MANUFACTURING: METHODS AND CONTROLS

4Q2012

COLORADO AGRICULTURAL & MECHANICAL DIETHYLSTILBESTROL IN CATTLE FEEDS --SAFETY OF USE OF COLLEGE ABBOTT LABORATORIES PHARMACEUTICAL SYSTEMS FOR THE CONTROL OF MANUFACTURE PROCESSING $ PACKING OF DRUGS PRODUCTS DIV MALLINCKRODT INC PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE) (ESUB) AS MANUFACTURED IN ST. LOUIS, MISSOURI MALLINCKRODT INC RESERPINE FINE CHEMICALS OF CANADA LTD PENNWALT CORPORATION PHARMACEUTICAL DIV CF BOEHRING AND SOEHNE GMBH INSTITUTE FOR THE STUDY OF ANALGESIC & SEDATIVE DRUGS UPJOHN CO CHEM SPECIALTIES CO INC NEW DRUG INSTITUTE LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO PENICK CORP INTERNATIONAL FLAVORS AND FRAGRANCES INC ER SQUIBB & CO/NJ NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER TREEMOND CO NEW YORK QUININE & CHEMICAL WORKS INC BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO UPJOHN CO SB PENICK & CO MALLINCKRODT INC PHARMACRAFT INC SOCIETE DES LABORATOIRES LABAZ SOCIETE DES LABORATOIRES LABAZ ARCHIMICA LTD PHARMACEUTICAL PRODUCTS COMPANY INC SUMNER CHEMICAL COMPANY INC LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO ANHEUSER BUSCH INC FRANK SAMUEL & COMPANY INC RESERPINE (BULK) DIHYDROCODEINE BITARTRATE ANHYDROUS TESTING FACILITIES FOR RAW MATERIALS & FINISHED GOODS COMBINED ADRENAL HORMONE ANTIBIOTIC THERAPY RAUNORMINE FERROUS FUMARATETOLERON ZIRCONIUM SULFANILAMIDE -2,4-DIMETHOXY-5-TRIAZINE (HB-182) CARNITINE CARNITINATE DICHLORIDE TCCTRICLOCARBAN (3,4,4'-TRICHLORO CARBANILIDE) A DESCRIPTION OF THE FACILITIES & OPERATING PROCEDURES POTASSIUM PARA AMINOSALICYLATE STYLOMYCIN (PUROMYCIN) VITA-BUSCH-12 CONCENTRATE POWDERED WHOLE RAUWOLFIA SERPENTINA ROOT RESERPINE CONTROL PROCEDURES MANUFACTURING ANTIDIABETIC COMPOUND BZ 55 REPORT OF MEETING ORINASE HORMONE AQUEOUS SUSPENSION HYDROCORTISONE ESKASUL MANUFACTURING DETAILS GRAMICIDIN ALVA FLAVORS, SEALVA FLAVORS STILBETIN SUPPLEMENT 50 (DIETHYLSTILBESTROL IN POLYETHYLENE GLYCOL)

Page 6

4Q2012EXCEL DMF# 221 222 223 224 225 I 226 I 227 228 229 230 231 232 233 234 235 I 236 237 238 I 239 240 241 I 242 243 I 244 I 245 246 I 247 248 249 250 I 251 252 I 253 I 4/27/1957 I II 4/12/1957 1/1/1940 I I I II 3/14/1957 10/5/1953 3/14/1957 1/1/1940 I 2/25/1957 4/5/1957 II 1/1/1940 I II II 1/1/1940 2/7/1957 I A II 2/8/1957 1/11/1957 1/29/1957 N I 11/13/1956 11/2/1956 I I I I I I I I II II II 4/8/1957 10/12/1956 1/1/1940 1/1/1940 1/1/1940 11/1/1956 1/1/1940 12/11/1956 1/1/1940 II 5/24/1956 STATUS Type SUBMIT DATE I I I I II 7/18/1956 8/7/1956 8/6/1956 8/1/1956 1/1/1940 HOLDER GALAT ALEXANDER SB PENICK AND CO ORIG SOCIETE DES LABORATOIRES LABAZ REHEIS CHEMICAL CO SUBJECT N-(3'DIMETHYLAMINO)PROPYL PHENOTHIAZING HCL (PROMAZINE HCL) AMMOIDIN (8-METHOXYPSORALEN, XANTHATOXIN) SODIUM DI-TERTIARY BUTYL-NAPHTHALENE SULFONATE SODIUM ALUMINUM CHLORHYDROXY LACTATE COMPLEX(CHLORACEL)

4Q2012

ABBOTT LABORATORIES PHARMACEUTICAL DIETHYLSTILBESTROL PWD & DIETHYLSTILBESTROL 50% SUSPEN. IN SOYBEAN OIL PRODUCTS DIV BRISTOL LABORATORIES INC DIV BRISTOL CALCIUM AMPHOMYCIN OINTMENT MYERS CO ELI LILLY AND CO CHLORDIETHYLNOL (DIETHYL CHLORO ETHYNYL CARBINOL) AMERICAN CYANAMID CO NEW YORK ACADEMY OF SCIENCES CHEMO PURO MFG CO VA MEDICAL CENTER PENCO OF LYNDHURST INC WALLERSTEIN CARBIDE AND CARBON CHEMS CO DIV UNION CARBIDE AND CARBON COR NOT AN ASSIGNED NUMBER AMERICAN ROLAND CORP ELLAY RUBBER COMPANY DIV WR GRACE AND CO GANE & INGRAM INC PHARMACIA AND UPJOHN SYNTEX LABORATORIES INC SUB SYNTEX CORP APOTHEKERNES LABORATORIUM A/S ARMOUR LABORATORIES DIV ARMOUR PHARMACEUTICAL CO ARMOUR LABORATORIES DIV ARMOUR PHARMACEUTICAL CO CHAS PFIZER AND CO INC STERWIN CHEMS INC SUB STERLING DRUG INC NORDSON PHARMACEUTCAL LABS INC CARLEN CORP ER SQUIBB & SONS AEROSOL OT-B POWDER MIX MEETINGS, MISCELLANEOUS PIPERAZINE PREPARATIONS CHEMOTHERAPY IN PSYCHIARY METHOCARBAMOL TYROTHRICIN & GRAMICIDIN PIPERAZINE, TECHNICAL

SYNTHETIC FERTILIZERS & CHEMICALS INC P HYDROXYPHENYLSALICYLAMIDE

RESERPINE FROM RAUWOLFIA VOMITORIA VINYL SHEETING & GRANULES - 0445X3 BENACTYZINE HCL NORETHINDRONE PREDNISONE, CRUDE AND CRYSTALLINE NEOMYCIN SULFATE 3,3' - ALLYLDIETHYLSTILBESTROL & 3,3' - ALLYL HEXESTROL VITAMIN B12 CONC. (FEED GRADE MILORGANITE)(VET MED) COBALAMIN CONCENTRATE SOLUTION SOLUTION OF COBALAMINE CONCENTRATE LEVONOR (1-AMPHETAMINE ALGINATE) CARLENDACIDE: VAGISEC (NAME UNDER WHICH MK'T BY JULIUS SCHMID, INC.) PACKAGING OF SQUIBB RADIOPHARMACEUTICALS

JENSEN-SALSBERY LABS DIV RICHARDSON- XYLOCAINE MERRILL INC MEER CORP RESERPINE JENSEN-SALSBERY LABS DIV RICHARDSON- SODIUM POLYTHIONATE SOLUTION(VET MED) MERRILL INC MERCK AND CO INC AQUEOUS SOLN RADIO-ACTIVE VITAMIN B12

Page 7

4Q2012EXCEL DMF# 254 I 255 256 257 258 I 259 I 260 261 262 263 264 265 266 I 267 I 268 269 270 271 272 I 273 274 I 275 I 276 277 278 279 280 281 282 283 284 285 286 I I I I I I A I I I I I II II II II 11/1/1957 11/6/1957 10/28/1957 8/8/1960 11/19/1957 11/21/1957 11/14/1957 12/5/1957 12/18/1957 1/16/1965 2/5/1958 1/1/1940 I II II 9/3/1957 1/1/1940 I I I I II II II II 1/1/1940 9/25/1957 1/1/1940 1/1/1940 1/1/1940 I 8/21/1951 I I I I I I II II II II 7/9/1957 5/15/1957 1/1/1940 6/18/1957 7/26/1957 1/1/1940 1/1/1940 6/13/1957 SYNTEX LABORATORIES INC SUB SYNTEX CORP ROUSSEL CORPORATION ROBECO CHEMICALS INC UPJOHN CO ROHM AND HAAS CO SB PENICK AND CO ORIG RHODIA INC I I I I II 5/1/1957 1/1/1940 4/2/1957 5/23/1967 STATUS Type SUBMIT DATE IV 4/4/1957 HOLDER SYBRON CORPORATION CHEMICAL DIVISION SOCIETE DES LABORATOIRES LABAZ FERRING AB RK LAROS CO GENERAL PACKAGING SERVICE SUBJECT IONAC C-269 AS MFG. IN NEW JERSEY (FORMERLY PERMUTIT COMPANY) ADRENOCHROME MONO SEMI CARBAZONE TRICORTAN(VET MED) FERLARON MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. HORMONE COCKTAIL PREDNISONE ROBANE NEOMYCIN SULFATE 0.5GM, COMMERICIAL GRADE, NOT USP POLYMER MC 2242 NEOMYCIN PALMITATE HYDROCHLORIDE6484 R.P. (VET MED)

4Q2012

JENSEN-SALSBERY LABS DIV RICHARDSON- STEROSAN (VET MED) MERRILL INC IVERS-LEE DIV BECTON-DICKINSON AND CO MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. RHODIA INC PIPERAZINE DIHYDROCHLORIDE AMMONIUM)RHODEX(VET MED) NORDA ESSENTIAL OIL AND CHEM CO INC CHAS PFIZER AND CO INC MERCK AND CO INC NEW YORK QUININE & CHEMICAL WORKS INC DOW CHEMICAL CO MICHIGAN DIV BIS (2-HYDROXY-5-CHLORO PHENYL) SULFIDE NEOMYCIN SULFATE(VET MED) NEOMYCIN SULFATE HYDROCORTISONE, HYDROCORTISONE ACETATE & CORTISONE ACETATE DISIDIUM DIHYDROGEN VERSENATE, A.R.

F.X. GASSNER, COLORADO STATE TESTOSTERONE & DIETHYLSTILBESTROL-CATTLE FEED MIXED W/INGREDS--SAFETY? UNIVERSITY ABBOTT LABORATORIES PHARMACEUTICAL DEXOXYEPHEDRINE HCL PRODUCTS DIV SYNTEX SA PREDNISOLONE NYSCO LABS INC ORTHANA KEMISK FABRIK A/S GENERAL MILLS INC SYNTEX SA MEDA PHARMACEUTICALS INC PETER HAND FOUNDATION NEW DRUG INSTITUTE SB PENICK AND CO ORIG SPARKS CORP EMERY PERSONAL CARE PRODUCTS GROUP PENTA - ERYTHRITOL TETRANITRATE TIMED DISINTEGRATION CAPSULES CORTICOTROPIN - GEL L-ARGININE MONHYDROCHLORIDE AND L-ARGININE AND L-GLUTAMATE 17A - ACETOXY PROGESTERONE 2 HYDROXY-METHYLENE-17 ALPHA METHYL-DIHYDRO-TESTOTERONE VITAMIN A-DESOXYCHOLIC ACID COMPLEX SYNTHESIS OF RESPERINE RESCINNAMINE PROCEDURE FOR HANDLING MEDICAL TABLETS ETHOXYLAN

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4Q2012EXCEL DMF# 287 I 288 289 I 290 291 I 292 I 293 294 I 295 296 I 297 I 298 299 I 300 I 301 302 I 303 304 I 305 306 307 308 309 I 310 311 312 313 314 315 I 316 317 I I 12/19/1958 12/22/1958 I I I I I II II I 1/1/1940 10/27/1958 11/4/1958 11/6/1958 10/24/1958 11/21/1958 I I I I IV I 8/5/1958 9/29/1958 9/29/1958 10/1/1958 10/22/1958 RALSTON PURINA CO GIVAUDAN CORPORATION AMERCHOL CORP CHEMO PURO MFG CO CHATTEM CHEMS DIV CHATTANOOGA MEDICINE CO CHEMICALS INC SE MASSENGILL CO-ORIG ICN PHARMACEUTICALS INC RHODIA INC PFIZER AND CO SYNTEX LABORATORIES INC SUB SYNTEX CORP RHODIA INC MF'G PROCEDURES FOR PURINA CHOWS GIV - TAN F OIL & LOTION - PHARMACOLOGY, SPECS. CHOLESTEROL & LANOLIN PRODUCTS OXELADIN CITRATE PHARAMCOLOGY, CLIN REPT., MF'G PROCESS ZIRCONIUM ALUMINUM CHLORHYDRATE ANTIPERSPIRANT & TOXCITY TESTS DRXTRAN POWDER-SPEC & MFG PROCESSES CONTROL PROCEDURES STANDARD OPERATION PROCEDURES PACKAGING OPERATIONS A MURRAY HILL PLANT 4632 R.P. MALEATE TERRAMYCIN-HYGROMYCIN PREMIX 19-NOR-17A-ETHINYL-TESTOSTERONE-17 B ACETATE 3828 R.P. FUMARATE - MF'G PROCEDURE I II 8/29/1958 9/18/1958 I I V 6/23/1958 7/16/1958 II 1/1/1940 I II 5/22/1958 1/1/1940 II 5/19/1958 I 4/29/1958 1/16/1958 I II 4/14/1958 4/9/1958 II 1/1/1940 I I 3/19/1958 3/19/1958 I 3/4/1958 3/10/1958 STATUS Type SUBMIT DATE 12/24/1957 HOLDER DISTILLATION PROD INDS DIV EASTMAN KODAK CO GENERAL ANILINE AND FILM CORP LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO UPJOHN CO SUBJECT MYVARET VITAMIN A FEED SUPPLEMENT RETINENE QUINOLATE(VET MED) DITHIAZANINE IODIDE (3,3'-DIETHYLTHIODICARBOCYANINE IODIDE) AEROSOL OT-N COMPRESSED TABLETS UPRIN, 5GR(ASPIRIN ANHYDRIDE)

4Q2012

SMITH KLINE & FRENCH LABS DIV GENERAL CONTROL PROCEDURES SMITHKLINE BECKMAN CORP JENSEN-SALSBERY LABS DIV RICHARDSON- FRAMYCETIN (SOFROMYCIN ROUSSEL) MERRILL INC MERCK AND CO INC HYDROCORT. 21-PHOSPHATE & NEOMYCIN SO4--OPTHAL. SOL. 0.5% & INJECT DISTILLATION PROD INDS DIV EASTMAN KODAK CO SCHUYLKILL CHEM CO SYNTEX LABORATORIES INC SUB SYNTEX CORP LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO SOCIETE DES LABORATOIRES LABAZ INDOCYANINE GREEN ALUMINUM ALLANTOINATES - SPECS, TOXICITY & CLINICAL TESTS 19 NOR - 17 ALPHA - METHYL - TESTOSTERONE SULFACHLOROPYRAZINEM - MFR & SPECS PROPYNYL CYCLOHEXANOL CARBAMATE

JENSEN-SALSBERY LABS DIV RICHARDSON- DEQUADIN(COMMON NAME DEQUALINIUM CHL) MERRILL INC JENSEN-SALSBERY LABS DIV RICHARDSON- TEOQUIL MERRILL INC HOFFMANN LA ROCHE INC FACILITIES AND CONTROLS --TRETINOIN JENSEN-SALSBERY LABS DIV RICHARDSON- SOMATOTROPIC HORMONE - JOURNAL REFERENCES MERRILL INC ELI LILLY AND CO 1 - CYCLOPPENTYL - 2 - AMINO PROPANE UPJOHN CO CHLORPROPAMIDE TABLETS-PHARMACOLOGY, CLIN RPTS,MFG'S PROCEEDS. & CNTRL

SYNTHETIC FERTILIZERS & CHEMICALS INC N-DIETHYLVANILLAMIDE (MFR. & SPECS)

Page 9

4Q2012EXCEL DMF# 318 319 320 I 321 322 I 323 I 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 I 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 A I I I I I I I I I I I I I I I I II II I II II 7/8/1959 7/13/1959 8/6/1959 8/16/1959 8/18/1959 8/24/1959 9/10/1959 9/4/1959 10/14/1959 10/19/1959 10/16/1959 11/2/1959 11/2/1959 11/16/1959 11/16/1959 12/2/1959 12/11/1959 I I I I I I I I I I I I I I II II II IV II I 1/21/1959 1/29/1959 2/9/1959 2/18/1959 3/2/1959 3/19/1959 3/4/1959 3/31/1959 4/14/1959 4/13/1959 4/20/1959 1/1/1940 5/18/1959 1/1/1940 6/23/1959 1/19/1959 I IV 1/7/1959 1/15/1959 ICI AMERICAS INC SPAN 85 - SPECS & ASSAY METHODS STATUS Type SUBMIT DATE I I III 12/31/1958 12/22/1958 1/6/1959 HOLDER ICI AMERICAS INC JORDAN KENNETH L MD WALLERSTEIN CO DIV TRAVENOL LABS INC SUBJECT ARLACEL; 165 ARLACEL; 161 MYRJ 59 - SPECIFICATION MEPHENESIN & PROCAINE HCL MYLASE, PHARMACEUTICAL

4Q2012

AYERST LABORATORIES INC DIV AMERICAN MF'G CONTROL PROCEDURES - SPECS FOR COMMONLY USED IN RAW MATERIALS HOME PRODUCTS CORP VICTOR M HERMELIN CO DIV K-V RAUVERTIN (IMPROVED) TABLETS (SPACE RELEASE) PHARMACAL CO SB PENICK AND CO ORIG CANDICIDIN SEARLE CHEM INC PARKE DAVIS DIV WARNER LAMBERT CO GEIGY CHEM CORP RUSPACK CORP DOW CHEMICAL CO MICHIGAN DIV MONSANTO COMPANY PABST LABS DIV PABST BREWING CO UPJOHN CO SOLVAY PHARMACEUTICALS ELI LILLY AND CO NOVO NORDISK AS CHEMICALS INC RHODIA INC KNOLL PHARMACEUTICAL CO UNIT BASF K&F CORP RHODIA INC UPJOHN CO STECKER CHEMICALS INC KV PHARMACEUTICAL CO SB PENICK AND CO ORIG GEIGY CHEM CORP AVECIA INC MINERALS & CHEMICALS PHILIPP CORP MONSANTO COMPANY WARNER LAMBERT CO ARMOUR PHARMACEUTICAL CO SB PENICK AND CO ORIG PRINCETON LAB PRODS CO ELI LILLY AND CO PHARMACIA LABS INC WALLERSTEIN GEIGY CHEM CORP MANUFACTURING PROCESSES 6A-METHYL-17-A-ACETOXYPROGESTERONE 1-DESOXYEPHEDRINE 3,5,3,4,-TETRACHLOROSALICYLANILIDE PROCEDURES FOR PRODUCING PHYSICIANS SAMPLES DOW 132 (4-TERT-BUTYL-2-CHLOROPHENYLMETHYL METHY PHOSPHORAMIDATE) HEMA (HYDROLYZED ETHYLENE MALEIC ANHYDRIDE) RESIN ZYMO-PABST SOLKETAL (GLYCEROL 1,2 - ISOPROPYLIDENE ETHER) DUVADILAN (ISOXSUPRINE HCL) MYRISTYL - 3 - HYDROXYBUTYLAMINE HCL - COMPOUND 06537 AMYLASE CONCENTRATE, CRUDE BACTERIAL IRON - HYDRODEXTRAN SPIRAMYCIN--MFG PROCEDURES DONDREN (MINERAL OIL) IGEPAL CO-630 SPECIAL STYRENE - MALEIC ACID COPOLYMER-TOXIC. DAA, CLIN REPTS & PHYSI CHARAC ASC-4, BRAND OF DIAPHENE NOLAMINE REPEA ACTION TABLETS PHOLCODINE - MFR' & SPECS MFG PROCEDS, ANALYTICAL METHODS & SPECS (SEQUESTRENE NA2CO) SDM-40 (25% ISOSORBIDE DINITRATE IN LACTOSE) MANUFACTURED IN TAMAQUA, PA PHARMASORB - REGULAR & COLLOIDAL SANTOPHEN1, O-BENZYL-P-CHLOROPHENOL PARENTERAL MANUFACTURE MANUFACTURING CONTROL PROCEDURES INOSITOL HEXANICOTINATE TRYPSIN, CHYMOTRYPSIN & RIBONUCLEASE - MF'G PROCEDURES & ASSAYS VORTEL TABLETS LOW MOLECULAR DEXTRAN ENZYMES SEQUESTREN NA FE, MF'G PROCEDURES & SPECS

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4Q2012EXCEL DMF# 356 357 358 I 359 360 361 362 I 363 I 364 365 I 366 367 I 368 369 370 371 372 I 373 374 375 376 377 I 378 379 I 380 I 381 382 383 384 385 386 I 387 388 I I II 7/11/1960 7/13/1960 I I I I I II II II II 5/12/1960 6/16/1960 6/27/1960 7/5/1960 7/7/1960 6/27/1960 6/6/1960 I II V 5/16/1960 5/25/1960 I I I I II II II 3/23/1960 3/31/1960 4/5/1960 4/28/1960 4/29/1960 A I I I III IV 2/24/1960 2/25/1960 2/29/1960 3/14/1960 3/21/1960 I II II 2/16/1960 2/17/1960 I IV 2/8/1960 3/3/1960 I 2/5/1960 KNOLL PHARMACEUTICAL CO UNIT BASF K&F CORP WALLERSTEIN RHONE POULENC PHARMACEUTICALS DIV RHONE POULENC INC KV PHARMACEUTICAL CO MF'G PROCEDURES, & CONTROLS AMYLOLYTIC AND PROTEOLYTIC ENZYMES EMULPHOR EL - 620 & EL - 719 PYRILAMINE - PHENYLEPHRINE SUSTAINED ACTION CAPSULES I I I II II 1/21/1960 1/21/1960 2/1/1960 1/27/1960 STATUS Type SUBMIT DATE I I II II 12/17/1959 1/6/1960 1/13/1960 HOLDER AMERICAN CYANAMID CO HELENA RUBINSTEIN INC SYNTEX LABORATORIES INC SUB SYNTEX CORP EASTMAN CHEMICAL CO ROBAPHARM LTD LABAZ LABORATORIES SUBJECT NEOMYCIN BASE - MF'G PROCEDURES & SPECS WHITE MAGNOLIA PERFUME OIL, FORMULATION 6A - CHLORO - PREDNISONE ACETATE (MFG PROCEDURE & SPECS) MYVACET MANUFACTURED IN KINGSPORT, TENNESSEE. ROBUDEN - MF'G PROCEDURES & SPECS

4Q2012

ETHYL (DIIODO-HYDROXY-BENZOYL) COUMARONE - MF'G PROCEDURES & SPECS

EATON LABS DIV NORWICH PHARMACAL CO NIDRAFUR MIX

WAITAKI INTERNATIONAL BIOSCIENCES SUB TRYPSIN & A - CHYMOTRYPSIN - PREPARTION & ASSAY METHODS WAITAKI CANADA LTD GIVAUDAN FLAVORS CORP FLAVOR FORMULATIONS BENZOL PROD CO HAYNIE PRODS REED-LANE INC VICTOR M HERMELIN CO DIV K-V PHARMACAL CO WORTHINGTON BIOCHEM CORP SB PENICK AND CO ORIG JOHN MANVILLE PRODUCTS CORP ROUSSEL CORPORATION ROYAL NETHERLANDS FERMENTATIONS LTD ELI LILLY AND CO HESS AND CLARK CO DIV RICHARDSONMERRELL INC LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO GB FERMENTATIONS ELI LILLY AND CO REYNAUD LTD SANOFI AVENTIS CHIMIE WYETH AYERST LABORATORIES INC TRANS 2 - PHENYLCYCLOPROPYL AMINE SULFATE - MANUF PROCEDURES ADMIRAL 123 - MF'G PROCEDURES CONTRACT PACKAGING FACILITIES LOCATED IN WAYNE, NJ DELFETA-SED PLUS T STEDYTABS DESOXYRIBONUCLEASE, PANCREAIC PHENAZOCINE HYDROBROMIDE - MF'G PROCED., SPECS, CLIN. & TOXICITY DATA MICRO-CEL & CELKATE DESERPIDINE SYNTHETIC PIMARICIN IMIDAZOLIUM BROMIDE DERIVAIVE NIHYDRAZONE - FIELD RESEARCH DATA FORMULATE FOR VARIOUS STANDARD COATING SOLUTIONS ,LAKEDYE PROLASE 300 TYLOSIN PERBRO CLOUD 1-(A-HYDROXYETHYL)-2-METHYL-5-NITRO-IMIDAZOLE,A NEW TRICHOMONOCIDE DIETHYLSTILBESTROL IMPLANTATION PELLETS

ABBOTT LABORATORIES PHARMACEUTICAL GALLIMYCIN -10+ ZOALENE PRODUCTS DIV NORWICH PHARMACAL CO FURALTADONE MASTITIS PREPARATION - SQUEEJET DISPENSER GEIGY CHEM CORP TINOPAL GS

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4Q2012EXCEL DMF# 389 390 391 392 I 393 394 395 396 397 I 398 399 I 400 I 401 402 403 I 404 I 405 I 406 407 408 409 410 411 412 413 I 414 415 416 417 418 A 419 I 420 421 A N IV 12/7/1960 1/3/1961 LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO CREMER OLEO GMBH AND CO KG NOT AN ASSIGNED NUMBER I I I A II II II 12/5/1960 12/21/1960 12/15/1960 12/28/1960 1/3/1961 I I I I I I I II II II II II 11/7/1960 11/7/1960 11/4/1960 11/10/1960 11/14/1960 11/25/1960 11/28/1960 11/28/1960 II 10/27/1960 II 10/27/1960 I I II II 10/10/1960 1/1/1940 10/20/1960 10/6/1960 I I IV 9/19/1960 10/3/1960 UPJOHN CO I I A I I I II II I 8/1/1960 8/2/1960 8/10/1960 1/1/1940 9/6/1960 STATUS Type SUBMIT DATE I I I II 7/15/1960 1/17/1960 7/18/1960 7/25/1960 HOLDER RP SCHERER CORP DRAGOCO INC DOLE CO SYNTEX LABORATORIES INC SUB SYNTEX CORP MCMILLEN FEED MILLS GENERAL MILLS INC DSM NUTRITIONAL PRODUCTS INC BIO-RAMO DRUG CO INC SHARP CORP SUBJECT FERROUS CITRATE AZULENE BROMELAIN - COMMERICAL GRADE MF'G PROCEDURES MFG OF BULK--19-NOR-17A-ETHINYL-TESTOSTERONE-17B-MONOENANTHATE

4Q2012

METHODS IN FACILS & CONTROLS FOR THE MFG, PROCESSING, PACK. OF DRUGS METHODS FACILS & CONTROLS - FOR MFG PROCESSING & PACK. OF DRUGS. 5% D-METHORPHAN HYDROBROMIDE ADSORBATE POWDER IRON POLYSACCHARIDE RAW MATERIAL USED IN MFG OF DI-FERRON INJECTION MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CONSHOHOCKEN, PENNSYLVANIA. MANUFACTURING ,PACKAGING AND CONTROLS PROCEDURES-THIS IS A VET MED DMF

EMERY PERSONAL CARE PRODUCTS NIMLESTROL; LANFRAX; LANTROL; LANFRAX WS55 (LANOLIN PRODUCTS) GROUP CIBA PHARMACEUTICAL CO DIV CIBA GEIGY CONTROLS, RAW MATERIAL SPECIFICATIONS CORP CHAS PFIZER AND CO INC OLEANSOMYCIN AND COCCIDIOSTAS IN POULTRY FEED ICI AMERICAS INC LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO RHONE POULENC PHARMACEUTICALS DIV RHONE POULENC INC RHONE POULENC PHARMACEUTICALS DIV RHONE POULENC INC SB PENICK AND CO ORIG WORTHINGTON BIOCHEM CORP WALLERSTEIN SYNTEX SA ER SQUIBB & SONS SYNTEX SA WITHMORE FEEDS INC SORBITAN MONOOLEATE (SPAN 80)(VET MED) REFERRED TO PESTICIDE BRANCH BIPHENAMINE HYDROCHLORIDE IGEPAL CO 887 (SAME AS IGEPAL 880) CONTRLS & TOXICITY BIOPAL VRO-20 NEODECYLLIN (NEOMYCIN UNDECYLENATE) CHYMOTRYPSIN (MANUF PROCEDURE) CELLASE 1000 PARAMETHASONE ACETATE--MANUF PROCEDS, PICCOLITE RESIN S 115 L DROMOSTANOLONE PROPIONATE ZOALENE (IMPROVED HIGH ENER-G-BROILER RATION Z MEDICATED W/ ZOALENE)

ABBOTT LABORATORIES PHARMACEUTICAL DIMETHADIONE PRODUCTS DIV SYNTEX SA FLURANDRENOLIDE SYNTEX SA SYNTEX SA WATSON LABORATORIES INC DR REDDYS LABORATORIES LTD 62 FLUORO-16 2 METHYL HCL 62 FLUORO - 16 2 METHYL PREDNISOLONE ACETATE 6- CHLORO - 6 - DEHYDRO- 17A - ACETOXY PROGESTERONE MESTRANOL3-METHOXY-17-ETHINYL-ESTRADIOL- MANUF PROCEDURES FLUOCINOLONE ACETONIDE MANUFACTURED IN FREEPORT, BAHAMAS AND CUERNAVACA, MEXICO. BUTYLPHENAMIDE WITEPSOL, HARD FAT SUPPOSITORY BASE

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4Q2012EXCEL DMF# 422 423 424 425 I 426 427 428 429 430 431 432 433 434 I 435 436 437 I 438 439 440 441 442 443 444 I 445 446 447 448 449 450 451 452 453 454 455 456 I 457 458 I I I 12/12/1961 12/28/1961 I I N I A I I I A I I II II IV 7/6/1961 9/18/1961 9/22/1961 9/29/1961 10/21/1961 7/13/1965 12/7/1961 12/12/1961 12/11/1961 II 8/21/1961 8/28/1961 I I I I I N 8/9/1961 II IV 6/30/1961 6/6/1961 7/12/1961 7/21/1961 2/10/1961 I N 6/30/1961 6/22/1961 I I I I I I I I II II II 2/6/1961 4/4/1961 4/11/1961 11/21/1960 4/18/1961 4/27/1961 4/28/1961 5/12/1961 6/22/1961 STATUS Type SUBMIT DATE I I I I 1/19/1961 2/24/1961 3/1/1961 3/16/1961 HOLDER GEIGY CHEM CORP HALES & HUNTER SB PENICK AND CO ORIG VICTOR M HERMELIN CO DIV K-V PHARMACAL CO UNION CARBIDE CORPORATION DUPHAR BV RP SCHERER CORP KAY-FRIES CHEMS SB PENICK AND CO ORIG STRONG COBB ARNER INC HOFFMANN LA ROCHE INC H LUNDBECK AND CO AS IMC CHEMICAL GROUP INC SUB INTL MINERALS & CHEM CORP RHODIA INC NOT AN ASSIGNED NUMBER VICTOR M HERMELIN CO DIV K-V PHARMACAL CO DOW CHEMICAL CO MICHIGAN DIV UNION CARBIDE AND CARBON CORP NATIONAL STARCH & CHEMICAL CORP PRODOTTI CHIMICI DOTTORI RE CHEMAGRO CORP NOT AN ASSIGNED NUMBER LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO GEIGY CHEM CORP CHAS PFIZER AND CO INC NOT AN ASSIGNED NUMBER ORTHO PHARMACEUTICAL CORP FMC CORP FMC BIOPOLYMER DIV SCHWARTZ BIORES INC NYSCO LABS INC NYSCO LABS INC FABBRICA ITALIANA SINTETICI SPA PRODOTTI CHIMICI DOTTORI RE FINE ORGANICS INC INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA ALLIED MILLS, INC. RT VANDERBILT CO QUALITY CONTROL PROCEDURE AVICEL MICROCRYSTALLINE CELLULOSE THIOGEL CHLORPHENIRAMINE MALEATE 4MGS TIMED RELEASED PELLETS PHENYLPRIPANOLAMINE HCL 50MG TIMED RELEASE PELLETS NITROFURANTION NITROFURANTOIN TEMASEPT CHLOROTHIAZIDE (BULK) - HYDROCHLOROTHIAZIDE FEED MANUF PLANTS AND CONTROL LABORATORIES WAYNE FEEDS VANCIDE ZP AND VANCIDE ZP DISPERSION SULFACHLOROPYRIDAZINE IRGASAN CF3 L'-LYSINE MONOHYDROCHLORIDE FACILITIES & CONTROL (SPOT WELDING) FACILITIES & CONTROLS (METHOXY FLURANE) UCON FLUID 50-HB-660 INSTANT CLEARJEL MEPROBAMATE NEGUVON SUBJECT CHEL 330 ACID (DIETHYLENETRIAMINE PENTACETIC ACID) STANDARD OPERATING PROCEDS FOR MANUF MEDICATED FEEDS MEPHENOXALONE- METHODS OF MANUF.

4Q2012

FACILS & CONTROLS USED FOR MANUF PROCESSING & PACKAGING OF NEW DRUGS SILICONE X-251 DYDROGESTERONE(FORMERLY ISOPREGNENONE) FERROUS CITRATE, MANUF SPECS & CLINICAL DATA BUTYLPHENAMIDE GLYCOPYRROLATE VICKS SINUS ANTICONGESTION TIME COVE TABLETS TRI-SPAN AMPROTROPINE RESINATE POWDER CALCIUM - AMPHOMYCIN TROMETHAMINE ETHIONAMIDE

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4Q2012EXCEL DMF# 459 460 461 462 463 464 465 466 467 468 469 470 471 472 473 474 475 476 477 478 I 479 480 I 481 482 483 484 485 486 487 488 I 489 I 490 491 492 493 494 495 496 I I N I I A I II IV II 7/6/1962 7/20/1962 7/25/1962 8/15/1962 II II 6/22/1962 6/27/1962 6/8/1962 I I I I I I I II 4/30/1962 4/26/1962 5/14/1962 5/18/1962 5/29/1962 6/12/1962 6/11/1962 6/12/1962 WORTHINGTON BIOCHEM CORP A WASSERMANN SPA SPENCER LABS DIV UNIMED INC PACO PACKAGING INC CHAS PFIZER AND CO INC CONTINENTAL CAN COMPANY CONTINENTAL CAN COMPANY ARGINASE PRODUCTION MEPROBAMATE SERC PHARMACEUTICAL PACKAGING OPERATION EPITHIAZIDE (P=2105) CONALOY (INTERNAL) CONALOY (EXTERNAL) I II 4/12/1962 4/18/1962 STATUS Type SUBMIT DATE I I I I I I I I A I I I I I I I I I I II II II II II II IV 1/4/1962 1/4/1962 1/8/1962 1/8/1962 2/6/1962 2/7/1962 2/6/1962 2/15/1962 2/15/1962 2/13/1962 2/26/1962 2/26/1962 2/26/1962 3/12/1962 3/21/1962 3/21/1962 3/23/1962 3/28/1962 3/27/1962 2/13/1962 HOLDER RT VANDERBILT CO RT VANDERBILT CO RT VANDERBILT CO PHARMACIA LABS INC SB PENICK AND CO ORIG ELANCO PRODS DIV ELI LILLY AND CO RHODIA INC A WASSERMANN SPA FIS FABBRICA ITALIANA SINTETICI SPA INDUSTRIA CHIMICA MILANESE SPA INDUSTRIA CHIMICA MILANESE SPA SYNTEX SA EI DUPONT DE NEMOURS AND CO DOW CHEMICAL CO MICHIGAN DIV STRONG COBB ARNER INC EI DUPONT DE NEMOURS AND CO METAL & THERMIT CORP NEISLER LABS INC DIV MALLINCKRODT INC CHAS PFIZER AND CO INC ARAPAHOE CHEMS INC DIV SYNTEX LABS INC RT VANDERBILT CO BAXTER LABS INC DIV TRAVENOL LABS INC SUBJECT VANCIDE BL VANCIDE BN METHYL TUADS RHEOMACRODEX BENZOMETHAMINE CHLORIDE HYGROMIX - CHICKENS PIPERACETAZINE TOLBUTAMIDE BULK CHLORDIAZEPOXIDE HCL PROCHLORPERAZINE MALEATE CHLORPROMAZINE HYDROCHLORIDE 2A-METHYL-DIHYDROTESTOSTERONE (CRYSTALLINE) BAYMAL COLLOIDAL ALUMINA BROMINATED SALICYLANILIDE MATRIX GEL SUSTAINED RELEASE SYSTEM

4Q2012

TEREPHTHALIC ACID IN COMBINATION W/ TETRACYCLINES MED. TURKEY FEEDS STANNOUS FLUORIDE DURABOND PRINCIPLE TEREPHTHALIC ACID IN POULTRY FEEDS CONTAINING OXYTETRACYCLINE HYDROXYPHENAMATE VANCIDE 2B TYROTHRICIN CHEMPLEXES

ABBOTT LABORATORIES PHARMACEUTICAL ARSANILIC ACID (SODIUM ARSANILATE) PRODUCTS DIV SEARLE CHEMS INC SUB GD SEARLE AND ANAVAR, PESA CO ELANC0 DIV ELI LILLY & CO CHYMOTRYPSIN TRYPSIN CRYSTALLIZED SALSBURY LABS NOT AN ASSIGNED NUMBER ROHM AND HAAS CO METAL & THERMIT CORP MARKEM IMAJE CORP ICI AMERICAS INC ASPERKINASE PRODUCTION STANNOUS OCTOATE INKS USED ON CAPSULES & TABLETS STANDARD DRUG MIXTURE #35--SDM#35 3-NITRO-4-HYDROXYPHENYLARSONIC ACID

Page 14

4Q2012EXCEL DMF# 497 498 499 500 501 502 503 I 504 505 506 507 508 509 510 511 512 513 514 I 515 516 517 518 519 520 521 522 523 524 525 526 527 I 528 529 530 531 I 532 I 533 I I 3/27/1963 II 4/5/1963 I I N 4/1/1963 IV II 3/25/1963 3/27/1963 I I I I I I N I I I I I I II 3/29/1963 3/19/1963 8/19/1970 3/11/1963 3/14/1963 3/20/1963 II I I 12/19/1962 2/6/1963 2/8/1963 2/15/1963 2/18/1963 2/28/1963 I I I I I I A I N I 1/17/1963 1/22/1963 IV III 10/17/1962 11/14/1962 11/28/1962 12/3/1962 11/30/1962 12/13/1962 1/3/1963 12/28/1962 STATUS Type SUBMIT DATE N I I I A I III 8/24/1962 8/27/1962 8/1/1962 10/8/1962 10/10/1962 10/12/1962 HOLDER NOT AN ASSIGNED NUMBER YARDLEY ELECTRIC CORP IRWIN NEISLER AND CO SCHUYLKILL CHEM CO BD MEDICAL PHARMACEUTICAL SYSTEMS PRIVATE BRANDS CO DEPT OF DEFENSE-ARMY DEFENSE MEDICAL MATERIEL BOARD SCHERING AG PENTAPHARM AG RHODIA INC INTERNATL CHEM & NUCLEAR PHARMS INC ALLERGAN SPA DOG LIFE CORP DOW CHEMICAL CO ROHM AND HAAS CO NOT AN ASSIGNED NUMBER GIST BROCADES LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO SCHERING AG SHELL CHEM CO PILLSBURY CO LEEDS DIXON LABORATORIES INC ORGANON INC COOPERATIVE MILLS NOT AN ASSIGNED NUMBER PFIZER AND CO TANABE SEIYAKU CO LTD WEST CO WITCO CHEM CO INC GENERAL ANILINE AND FILM CORP LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO ALABAMA FLOUR MILLS CALBIOCHEM CORP NOT AN ASSIGNED NUMBER SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP ALBERS MILLING CO SK&F LABS PERSONNEL SUMMARY OF TRAINING AND EXPERIENCE 5-IODO-2-DEOXYURIDINE (IUDR) CURRICULA VITAE DL-CARNITINE HYDROCHLORIDE PLEASE REFER TO D1545 AMD/OR D1546 WHICH REPLACE D524 EMCOL E-607 QUATERNARY AMMONIUM COMPOUND UVINUL MS-40 ORGANIC CHEMICAL RSCH SECTION, PERSONNEL QUALIFICATIONS RED HA BROILER CONCENTRATE NON-MEDICATED FEEDS 5-IODO-2-DEOXYURIDINE FLURANDRENOLONE ACETATE AGOSAN IN 836 (FENYRIPOL) ALLANTOIN - METHIONINE COMPLEXES HYPAK (R) SCF (R) (STERILE) AND BULK (NON-STERILE) SYRINGE SYSTEMS PACKAGING AND CONTROL SPECIFICATIONS 2 PAM CHLORIDE 17 ALPHA-ETHINYL-19-NOR-TESTOSTERONE REPTILASE DIMETRIDAZOLE [EMTRYL] 5-IODODEOXYURIDINE 5-IODODEOXYURIDINE (5IUDR) TABLETTING MIXURE AND FLAVORING TECHNIQUES SENTRY POLYOX WATER SOLUBLE RESINS - NF GRADE RHOZYME J-25 CONCENTRATE SUBJECT

4Q2012

ULTRAVIOLET ABSORBERS (U.V.Q, U.V. 24, & U.V.24 PHARMACEUTICAL GRADE) 17A-ETHINYL-19-NOR-TESTOSTERONE ACETATE DDVP-RESIN (2,2-DICHLOROVINYL DIMETHYL PHOSPHATE) PROCESS EQUIPMENT AND PROCEDURES OPERATING PROCEDURES DEXAMETHASONE METHODS USED IN MANUFACTURING, PROCESSING AND PACKING DRUGS

EQUIPMENT & CONTROL PROCDS FOR MANUF MEDICATED FEEDS FOR ALBERS FEED

Page 15

4Q2012EXCEL DMF# 534 I 535 536 537 538 539 540 541 542 543 544 I 545 546 547 548 549 I 550 551 I 552 553 554 I 555 I 556 557 558 559 560 561 I 562 I 563 I 564 565 I 566 N I V 5/16/1963 5/23/1963 UPJOHN CO STERLING-WINTHROP RES INST DIV STERLING DRUG INC NOT AN ASSIGNED NUMBER BULK CHEMICALS , METHOD OF PREPARATION INVESTIGATIONAL EXEMPTION FOR WIN 18,320-3 (VETERINARY USE) I 5/22/1963 5/28/1963 I I I I I II V II II 5/20/1963 5/20/1963 5/20/1963 11/14/1962 5/21/1963 4/24/1963 5/16/1963 N I II IV 5/17/1963 5/20/1963 I II II 5/20/1963 4/19/1963 I I I I I V II 5/6/1963 5/9/1963 5/10/1963 5/14/1963 5/10/1963 OZARK-MAHONING CO RUSON LABS INC ARMOUR PHARMACEUTICAL CO NUTRENA MILS, DIV OF CARGILL, INC. STERLING-WINTHROP RES INST DIV STERLING DRUG INC BURROUGHS WELLCOME CO MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC NOT AN ASSIGNED NUMBER ARMOUR PHARMACEUTICAL CO SODIUM MONOFLUOROPHOSPHATE I I I N I I I I I IV II V II II 4/25/1963 4/25/1963 12/12/1962 5/1/1963 5/1/1963 4/23/1963 I I 4/9/1963 4/12/1963 4/23/1963 PARKE DAVIS & CO RHODIA INC MASON-KELLER CORP NOT AN ASSIGNED NUMBER GANES CHEMICALS INC WYETH INC SALSBURY LABS ORGANON INC MALLINCKRODT INC WITHMORE FEEDS INC 7 BETA-HYDROXYPROPYL THEOPHYLLINE INVESTIGATIONAL NEW DRUG MASTER FILE EMTRYL TABLETS DEXAMETHASONE INVESTIGATIONAL DRUGS STATUS Type SUBMIT DATE V 3/14/1963 HOLDER CHEMAGRO CORP SUBJECT

4Q2012

STUDY RESIDUE PROBLS RELATED TO U/OF EXPERIMENTAL ORGANOPHOSPHORUS COM QUALIFICATIONS OF PARKE, DAVIS & CO. RESEARCH PERSONNEL ETHOPROPAZINE MASON-KELLER CORPORATION

36% POULTRY CONCENTRATE 291A /44% BROILER CONCENTRATE UNMEDICATED 190A

ASSAY INFOR RUSON LABS [PRINCIPAL QUANTITAIVE DETER QUATERNARY VITAE] PANCREAIC ENZYME CONCENTRATE FACILITIES FOR CARGILL, INC (THIS IS A VETDMF) INVESTIGATIONAL EXEMPTION FOR WIN 5063 (VETERINARY USE) DARVISIL THIABENDAZOLE

CHYMOTRYPSIN CRYSTALLIZED

ONYX CHEM CO DIV MILLMASTER ONYX ISOTHAN Q-75 CORP ABBOTT LABORATORIES PHARMACEUTICAL M-259 (NSC 51954) PRODUCTS DIV ARMOUR PHARMACEUTICAL CO PURIFIED ENZYME CONCENTRATE CHEMAGRO CORP ICI AMERICAS INC RHODIA INC DOW CHEMICAL CO MICHIGAN DIV BAYER 2353 (YOMESAN) BRIJ 30 POLYOXYETHYLENE (4) LAURYL ETHER FLAVORS: PHARMACEUTICAL FLAVOR RF451, IMITATION FLAVOR 520B TROLENE FM MEDICATED PREMIX

AYERST LABORATORIES INC DIV AMERICAN STUDIES ON ORBENIN, CLOXACILLIN , BRI 1621 , AY 6203 HOME PRODUCTS CORP WARNER LAMBERT CO PHARMACEUTICAL PERSONNEL FACILITIES AND OPERATING PROCEDURE RESEARCH DIVISION BAXTER LABS INC DIV TRAVENOL LABS INC RESEARCH AND DEVELOPMENT GROUP

Page 16

4Q2012EXCEL DMF# 567 I 568 569 570 571 572 573 574 575 576 577 578 579 580 581 582 583 I 584 I 585 I 586 587 588 589 590 591 592 593 594 595 596 597 598 599 600 I 601 I 602 I I 6/24/1963 II 6/27/1963 I I I I I I N I I I I I I I II II II II IV II 6/6/1963 7/5/1963 5/31/1963 5/31/1963 6/13/1963 7/11/1963 6/18/1963 6/18/1963 6/7/1963 6/26/1963 6/10/1963 6/10/1963 6/21/1963 5/24/1963 I 5/28/1963 II 3/5/1963 N I I I I I N I I I I I I I I I II I II 6/5/1963 6/11/1963 6/12/1963 6/12/1963 6/11/1963 6/7/1963 6/5/1963 6/11/1963 6/5/1963 II 5/20/1963 5/28/1963 5/31/1963 5/29/1963 6/3/1963 STATUS Type SUBMIT DATE V 5/23/1963 HOLDER STERLING-WINTHROP RES INST DIV STERLING DRUG INC NOT AN ASSIGNED NUMBER NATL INST HLTH CLINCL CTR PHARMACY 3M PHARMS SYNTEX SA SB PENICK AND CO ORIG SB PENICK AND CO ORIG NOT AN ASSIGNED NUMBER CUTTER BIOL DIV MILES LABS INC RHODIA INC RHODIA INC RHODIA INC RHODIA INC BURROUGHS WELLCOME CO FARM BUREAU SERVICES ORGANON INC CIBA GEIGY CORP PHARMACEUTICAL DIVISION AYERST LABORATORIES INC DIV AMERICAN HOME PRODUCTS CORP SANDOZ CONSUMER PHARMACEUTICALS DIV INOLEX CHEM CO DOW CHEMICAL CO MICHIGAN DIV NATL INST HLTH CLINCL CTR PHARMACY RORER PHARM CORP SUB RORER GROUP PARKE DAVIS & CO ADAMHA NIMH ADDICTION RESCTR NOT AN ASSIGNED NUMBER SANDOZ PHARMS CORP DIV SANDOZ INC ROUSSEL CORPORATION AMERICAN CYANAMID CO AMERICAN CYANAMID CO AMERICAN CYANAMID CO NOVO INDUSTRI AS ALBERS MILLING CO. LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO SYNTEX LABORATORIES INC SUB SYNTEX CORP AH ROBINS CO INVESTIGATIONAL DRUGS INOSITOL HEXANICOTINATE CL 45,167 OR STYRYLPYRIDINIUM (INVESTIGATIONNAL DRUG) STYRYLQUINOLINIUM (CL40,001) INVESTIGATIONAL USE SUBJECT COMBINED W/INVEST. EXEMPTION FOR WIN 18,320-3

4Q2012

STATEMENT OF PERSONNEL FACILS AND CONTROLS FOR PROCESSING A NEW DRUG INVESTIGATIONAL NEW DRUG PROCEDURES INVESTIGATIONAL DRUG, 6APLHS-FLUORO-16-ALPHA-HYDROCORTISOME BISMUTH SUBSALICYLATE PASTE DOXAPRAM HCL; AHR-619 MANUF RESCH AND PERSONNEL FILE RSCH FACILS, EQUIPMENT & CONTROLS 11-16 SPIRAMYCIN METHOTRIMEPRAZINE ISOMETAMIDIAM HEVOPHACETOPERANE (LIDEPRAN)(RP8228) HCL PERTINANT DATA ON THE RESEARCH ACTIVITIES DEALERS USING THIS MASTER FILE AND MILL LOCATION DEXAMETHASONE 21-PHOSPHATE PERSONNEL, FACILITIES & TESTING PROCEDS, AND LABELING INVEST DRUGS METHYRIDINE DORSEY LABORATORIES MANUF PROCEDURE FOR HIGH POTENCY LIPASE INVESTIGATIONAL DRUG MASTER FILE FOR FUTURE REFS NOTICES T/B SUBMITT COOPERATIVE STUDY GROUPS OF CLINICAL STUDIES PANEL RECOSEN, INVESTIGATIONAL DRUG VIRAL AND BACTERIAL VACCINES INVESTIGATIONAL DRUGS SKF-5390,ARC VII-B-4;V-B-1;V-C-5;V-A-29

SULFATETHOXYPYRIDAZINE W/& WITHOUT CHLORTETRACYCTINE IN SWINE FEED EXP CRYSTALLINE TRYPSIN - NOVO DELETED 10 - 11 - 63 ALBERS LAB - MIX POULTRY TRIAMTERENE (VET) 6-ALPHA-9-A-DIFLUORO-16-A-METHYL PREDNISOLONE DESIGNATED RS 2177 FACILITIES, METHODS AND PERSONNEL INVESTIGATIONAL DRUG

Page 17

4Q2012EXCEL DMF# 603 I 604 I 605 I 606 607 608 I 609 I 610 611 I 612 I 613 614 615 616 617 618 I 619 620 621 622 623 624 I 625 I 626 627 628 I 629 630 631 632 I 633 634 I I II 8/5/1963 3/8/1963 I I N 8/9/1963 8/8/1963 8/12/1963 I I II 7/24/1963 7/22/1963 8/8/1963 7/2/1963 I I I I I II IV 8/5/1963 7/30/1963 7/17/1963 6/12/1963 7/26/1963 4/25/1963 I I I I N 6/18/1963 5/10/1963 3/14/1963 3/14/1963 7/29/1963 7/30/1963 I 6/11/1963 6/11/1963 6/3/1963 I I II 2/14/1963 7/30/1963 5/31/1963 6/25/1963 7/5/1963 STATUS Type SUBMIT DATE 6/3/1963 HOLDER MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC MERRELL DOW PHARMS INC SUB MARION MERRELL DOW INC WARNER LAMBERT CO PHARMACEUTICAL RESEARCH DIVISION CORVEL, INC. SCHWARTZ BIORESEARCH INC BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO WYETH INC WARNER LAMBERT CO PHARMACEUTICAL RESEARCH DIVISION BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO VA MEDICAL CENTER PROCTER AND GAMBLE CO MALLINCKRODT CHEMICAL WORKS KIERNAN-HUGHES INC NOT AN ASSIGNED NUMBER CIBA PHARMACEUTICAL CO DIV CIBA GEIGY GENERAL INFO-DISCONTINUED INVESTIGATIONAL DRUGS CORP AMERICAN CYANAMID CO SULFATETHOXYPYRIDAZINE AND CHLORTETRACYCLINE(VET) C ALBERT SAUTER CO WALLERSTEIN CUDAHY LABS DIV CUDAHY PACKING CO WISC ALUMNI RES FDTN SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP IVERS-LEE MIDWEST CO INC DIV BECTONDICKINSON AND CO DOMINION PRODUCTS INC PABST LABS DIV PABST BREWING CO PACKAGING OF MEDICATION (BLISTER PACKAGES) DIHYDROXYACETONE (THIS DSENT TO COLOR ADD. ON 9.6.63) ELASTASE FORMULA 7100 (VET) CYTOMEL IMPLANT PELLETS(VET) PACKAGING FACILITIES AND CONTROLS PHARMACEUTICAL FLAVORS #124-B-12 & 121-B-12 5-IODO-2'-DEOXYURIDINE SUBJECT HADACIDIN SOD. DIHYDRATE (NSC 521778) & HADACIDIN POTASS. NSC 72962

4Q2012

MFG & PROCESS DATA;MONITORS RESPONS. FOR CLIN. & PHARMACOLOG. DATA W 3361, A LIQUID ANTACID FORMULATION ---CHITOSAN ANTACID TYLOSIN; DIHYDROSTREPTOMYCIN; VIT. A & D ARE ACT. INGREDS. (VET MED) ADENOSINE-5' MONOPHOSPHATE (AMP) ---MFG PROCEDURE ACTINOGAN (NSC 54496 D) A649 (NSC 38270) GENERAL INFO DISCONTINUED INVESTIGATIONAL DRUGS GENERAL INFO DISCONTINUED INVESTIGATIONAL DRUGS MITOMYCIN C (NSC 26,980) VA INVESTIGATORS COMPANY'S PROCEDURES FOR TESTING NDA PRIOR TO SUBMITTING FOR APPROVAL GENERAL INFO--DISCONTINUED INVESTIGATIONAL DRUGS METHODS, FACILITIES AND CONTROLS

ABBOTT LABORATORIES PHARMACEUTICAL SPECTINOMYCIN (M-141, ABBOTT)(VET) PRODUCTS DIV ABBOTT LABS 2-(2-FORMYLHYDRAZINO)-4-(5-NITRO-2-FURYL)-THIAZOLE(AS-L7665)&A-2L203 DOW CHEMICAL CO MICHIGAN DIV NOT AN ASSIGNED NUMBER BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO ELANC0 DIV ELI LILLY & CO SOLVAY PHARMACEUTICALS CURRICULA VITAE OF CLINICAL INVESTIGATORS INVEST DRUG STREPTOMYCIN,TYLOSIN, ERYTHROMYCIN & PENICILLIN BOLUS(VET) GENERAL INFO-DISCN. INVESTIGATIONAL DRUGS PROPYLENE GLYCOL--TRADE NAME SIRLENE(VET)

Page 18

4Q2012EXCEL DMF# 635 636 637 638 639 640 641 I 642 643 644 645 646 647 I 648 649 650 651 652 653 654 655 656 657 658 659 660 661 662 663 664 665 666 I 667 668 669 670 671 672 673 N N I I I I I II II II II II 9/3/1963 9/12/1963 8/15/1963 8/15/1963 9/9/1963 I I I I I I I I I I I I I I I I I I II II V II III V V 9/10/1963 8/26/1963 9/4/1963 8/22/1963 8/22/1963 4/15/1963 9/9/1963 4/15/1963 4/22/1963 4/25/1963 4/11/1963 4/15/1963 4/15/1963 4/15/1963 5/27/1963 9/24/1963 4/15/1963 8/1/1963 8/27/1963 I I I I I II II II 8/27/1963 8/20/1963 1/1/1940 1/1/1940 8/27/1963 8/26/1963 STATUS Type SUBMIT DATE I I I N I I 7/22/1963 8/8/1963 7/19/1963 III II 8/16/1963 8/16/1963 8/15/1963 HOLDER JT BAKER CHEMICAL CO JT BAKER CHEMICAL CO FORT DODGE LABORATORIES NOT AN ASSIGNED NUMBER DORSEY LABORATORIES DIV SANDOZ INC HAMPSHIRE CHEMICAL CORP MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC FINE ORGANICS INC RT VANDERBILT CO UPJOHN CO CHEMAGRO CORP HOFFMANN LA ROCHE INC CREATIVE PACKAGING CO DIV ELI LILLY AND CO WARNER PACKAGING CORVEL, INC. KIRKHILL RUBBER CO MOORMAN MANUFACTURING CO. MOORMAN MANUFACTURING CO. PARKE DAVIS & CO VOCATIONAL REHABILITATION SERVICES PARKE DAVIS & CO PARKE DAVIS & CO PARKE DAVIS & CO PARKE DAVIS & CO PARKE DAVIS & CO PARKE DAVIS & CO PARKE DAVIS & CO PARKE DAVIS & CO PARKE DAVIS & CO PARKE DAVIS & CO COMMERCIAL SOLVENTS CORP HESS AND CLARK CO DIV RICHARDSONMERRELL INC NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER CUDAHY PACKING CO PACIFIC NORTHWEST PRODUCTS, INC. INTERMOUNTAIN ELEVATOR CO. IMPERIAL PRE-MIX CO. ALBION VETERINARY SUPPLY SUBJECT DIETHYLPROPION CONTAINING TARTARIC ACID DIETHYLPROPION

4Q2012

P-234 (INJECT. ANTHELMINTIC IN SWINE) CALLED TRICHLORPHON & NEGUVON VASCULA (IS KNOWN IN GERMANY-USED TO IMPROVE PERIPHERAL CIRCULATION) HAMPSHIRE NTA NA3 (TRISODIUM NITRILOTRIACETATE MONOHYDRATE) 1-METHYL-1-(B-CHLOROETHYL) ETHYLENIMONIUM PICRYSULFONATE TEMASEPT II (TBS) (CHEM NAME-3,4'5 TRIBROMSALICYLANILIDE) VANGARD MB (MONOBENZONE) NSC-51173, (U-10955)--5A-ANDROSTAN-3-ONE,2A-FLUORO-17B-HYDROXY C0-RAL--0,0 DIETHYLO-3-CHLORO-4 METHYL-2-OXO-2H-1-BENZOPYRAN-7-YL LIBRIUM; TRANIMAL(VET) CONTRACT PACKAGING PACKAGING FACILITIES AND CONTROLS TYLOSIN 20MG PER CC AND NEOMYCIN 10MG PER CC (VET) KIRKHILL COMPOUND 270-A-905 AND 285-C-1156 RESEARCH EXPERIMENT # 1192 (VET) RESEARCH EXPERIMENT # 1167(VET) CLINICAL INVESTIGATION 461 PROCESSING--UNDER SUB-CONTRACTING ARRANGEMENTS FOR PHARMACEUT. FIRMS CLINICAL INVESTIGATION--CI-446 CLINICAL INVESTIGATION --CI 442 CLINICAL INVESTIGATION--CI423 CLINICAL INVESTIGATIONS--CI 400 AND 421 CLINICAL INVESTIGATION--CI 384 CLINICAL INVESTIGATION--CI 344 CLINICAL INVESTIGATION--CI-383 CLINICAL INVESTIGATION-- CI-395 CLINICAL INVESTIGATION--CI-499 (BUSCOPAN) CLINICAL INVESTIGATION--CI-462 COMBINATION-FEED GRADE ZINC BACITRACIN & DES IN CATTLE FEEDS (VET) NITROFURAZONE(VET)

DIETHYLSTILBESTROL MIX IN-CUDAHY 3% PHOSPHORUS MIXER W/DES 0.0088%(VET DIETHYLSTILBESTROL(VET) DIETHYLSTILBESTROL(VET) DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET) DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET)

Page 19

4Q2012EXCEL DMF# 674 675 676 I 677 678 679 680 681 682 683 684 685 686 687 688 689 I 690 691 I 692 693 694 695 696 697 698 699 700 701 I 702 703 704 705 706 707 708 709 I I I I I N I I II II II 6/16/1963 4/2/1963 10/24/1963 II II II 6/30/1961 1/21/1963 8/5/1963 10/16/1963 I I I I I I I I I II II II II II II V II 4/10/1963 10/2/1963 10/7/1963 10/11/1963 5/20/1963 3/11/1963 4/26/1963 4/19/1963 10/25/1963 8/30/1962 I V 10/1/1963 10/4/1963 I I I I I I I I I I I I V V II IV II II II II 9/27/1963 9/3/1963 8/26/1963 9/13/1963 8/26/1963 9/27/1963 8/5/1963 10/1/1963 9/24/1963 9/24/1963 8/27/1963 9/23/1963 10/3/1963 STATUS Type SUBMIT DATE A I IV II II 9/19/1963 9/26/1963 5/20/1963 HOLDER INTERNATIONAL SPECIALTY PRODUCTS NORWICH PHARMACAL CO STERLING-WINTHROP RES INST DIV STERLING DRUG INC SCHERING AG MERCK AND CO INC CORVEL, INC. MERCK AND CO INC CORVEL, INC. DOW CORNING CORP ARIZONA MILLING CO. CELANESE CORP GRAIN PROCESSING CORP GRAIN PROCESSING CORP HOFFMANN LA ROCHE INC UNION CARBIDE CORPORATION AMERICAN GASKET AND RUBBER CO DIV DART INDUSTRIES INC GRAIN PROCESSING CORP LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO ADRIA LABORATORIES DIV ERBAMONT INC ALBER MILLING CO. GEM FEED CO. ORGANON INC SALSBURY LABS ELANCO PRODS DIV ELI LILLY AND CO CHAS PFIZER AND CO INC ELANCO PRODS DIV ELI LILLY AND CO DOW CHEMICAL CO MICHIGAN DIV SUBJECT

4Q2012

GANTREZ AN (PVM/MA)-CHEM NAME:POLY(METHYL VINYL ETHER/MALEIC ANHYDRIDE VALSYN (FURALTADONE) WATER MIX(VET) STANOZOLOL (PYRAZOLE C 14), LABELLED (VET) SH-714 PRO-STREP CRUMBLES (VET) TYLOSIN & DIHYDROSTREPTOMYCIN (VET) AMPROL SUPER PLUS (AMPROLIUM & ETHOPABATE)(VET) TYLOSIN & NEOMYCIN USED AS AN EXPERIMENTAL PRODUCT(VET) SILICONE RUBBER DOW CORNING SILASTIC DIETHYLSTILBESTROL INTERMEDIATE PREMIXES --BEEF CATTLE FEEDS (VET) 1,3 BUTYLENE GLYCOL REQUEST TO MARKET EGGS OF PULLETS FED MANGANESE BACITRACIN(VET) REQUEST TO MARKET STEERS FED MANGANESE BACITRACIN(VET) CLEARANCE FOR SALE OF PPOULTRY, TREATED WITH SULFADIMETHOXINE(VET) UCONPROPELLANTS FORMULATION OF THE RUBBER COMPOUND USED BY RIKER LABS REQUEST TO MARKET TURKEYS FED MANGANESE BACITRACIN (VET) SULFAMETHAZINE LORAMINE SBU -185 (UNDECYLENIC ACID-MONOETHANOLAMIDE) MFG OF DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET) DIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET) PREPARATION OF CORTICOSTERONE FROM HYDROCORTISONE REQUEST AUTH. TO MARKET BROILERS FED NOVASTA(VET) VET. INVEST. DRUGS-TYLOSIN FOR BROILER HENS,BROOD SOWS & CATTLE(VET) COMPOUND P-3693A (VET) RS-1280 RESIDUALS IN LAYING CHICKENS(VET) ZOALENE W/ARSANILIC ACID OR SODIUM ARSANILATE IN MEDICATED FEED (VET)

ABBOTT LABORATORIES PHARMACEUTICAL ARSANILIC ACID--SODIUM ARSANILATE WITH ZOALENE (VET DMF) PRODUCTS DIV MERCK AND CO INC AMPROLIUM MEDICATED FEED -(3-NITRO-4-HYDROXYPHENYLARSONIC ACID) (VET) DORSEY LABORATORIES DIV SANDOZ INC ELANCO PRODS DIV ELI LILLY AND CO SALSBURY LABS NOT AN ASSIGNED NUMBER MERCK AND CO INC ER SQUIBB AND SONS INC AMPROLIUM IN CHICKENS(VET) MYCOSTAIN -20 IN PIGS (VET) TARPAN (HF/1984; HF/1931 HCL) CHLORMADINONE ACETATE PREMIX (VET)MADE PART OF DMF-699V NOVASTA-A FINISHED CHICKEN FEED(VET)

ABBOTT LABORATORIES PHARMACEUTICAL GALLIMYCIN (R)-10(ERYTHROMYCIN THIOCYANATE, ABBOTT) PRODUCTS DIV

Page 20

4Q2012EXCEL DMF# 710 I 711 712 713 714 715 716 I 717 718 719 720 721 722 I 723 724 725 726 727 728 729 730 731 732 733 734 I 735 736 737 I 738 739 740 I 741 742 I 743 744 745 I N A II 12/2/1963 V 11/1/1963 I II I 11/20/1963 11/29/1963 DOW CHEMICAL CO MICHIGAN DIV I I II V IV 11/15/1963 10/31/1963 11/26/1963 I I II II 10/14/1963 11/7/1963 11/18/1963 I I I I I I I I I I I II II II IV II II V II 7/11/1963 3/7/1963 12/10/1963 7/18/1963 8/8/1963 11/13/1963 11/4/1963 11/7/1963 8/6/1963 10/21/1963 11/14/1963 11/15/1963 NOVO NORDISK AS NATL INST HLTH NCI PUREX LABS JOHN W. ESHELMAN ELANCO PRODS DIV ELI LILLY AND CO BURROUGHS WELLCOME CO ELANCO PRODS DIV ELI LILLY AND CO ELANCO PRODS DIV ELI LILLY AND CO OZARK-MAHONING CO STATE OF UTAH, DEPT. OF FISH AND GAME LAKELAND CASH FEED CRYSTALLINE PORCINE TYPSIN, NOVO (FOR MFG,CONTROL SEE DMF-598) DRUG DEVELOPMENT PROGRAM DRAKEOL-ARLACEL RED ROSE SUPPLEMENTS AND CONCENTRATES (VET) TAPAZOLE AND DIETHYLSTILBESTROL FOR CATTLE (VET) CANOPAR BRAND THENIUM CLOSYLATE (VET) I A I A A II I IV IV II 11/4/1963 10/23/1963 10/28/1963 10/23/1963 11/5/1963 11/5/1963 I I I I I II II II II 8/15/1963 8/19/1963 10/11/1963 10/16/1963 10/8/1963 11/4/1963 STATUS Type SUBMIT DATE 10/16/1963 HOLDER CREATIVE PACKAGING CO DIV ELI LILLY AND CO CALIFORNIA CATTLE SUPPLY CO., INC. CAPITAL FEED AND SEED CO. STEPAN COMPANY OZARK-MAHONING CO OWENS ILLINOIS INC SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP SYNTEX SA STEPAN CO LILLY RES LABS DIV ELI LILLY CO STEPAN CO COLORCON INC SUBJECT CONTRACT PACKAGING OF FOOD & DRUG ADM. CONTROLLED PRODUCTS DIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET) DIETHYLENESTILBESTROL INTERMEDIATE PREMIXES (VET) LIPAL 9-LA (POLYOXYETHYLENE (9) LAURYL ETHER SODIUM FLUOROSTANNITES DISPOSABLE SYRINGE SKF 385 TRANYLCYPROMINE (VET) 6A-FLUORO-16A-METHYL DELTA 1,4-PREGNADIENE-11B,17A-DIOL-3,20-DIONE MCT (MEDIUM CHAIN TRIGLYCERIDES) PERSONNEL FILE: REQUIREMENTS FOR TECHNICAL & PROFESSIONAL STAFF WECOBEE BASES COLOR DISPERSIONS AND MIXED EXCIPIENTS

4Q2012

OHIO AGRICULTURAL EXPERIMENT STATION HESPERIDIN IN CATTLE (VET)

INVESTIGATIONS W/SWINE FED A COMBINATION OF TYLOSIN-STREPTOMYCIN (VET) STREPTOMYCIN-TYLOSIN-ERYTHROMYCIN-PENICILLIN COMBIN. ALONE & W/DES(VET STANNOUS FLUORIDE ENHEPTIN (2-AMINO-5 NITROTHIAZOLE) IN RAINBOW TROUT(VET) DIETHYLSTILBESTROL INTERMEDIATE PREMIXES (VET)

ABBOTT LABORATORIES PHARMACEUTICAL GALLIMYCIN-10(ERYTHROMYCIN,ABBOTT) & PRO-GEN (ARSANILIC ACID) (VET) PRODUCTS DIV ROMER AGRICULTURAL ENTERPRISES FEEDS CONTAINING DES(VET) PRO-VITA CO. SEARLE CHEMS INC SUB GD SEARLE AND CO GD SEARLE AND CO MOORMAN MFG. CO. KANSAS STATE UNIV. DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET) METRULEN,METRULEN-M,AND OVULEN --ETHYNODIOL DIACETATE S N-263, A SULFATED POLYSACCHARIDE (VET) RESEARCH EXPERIMENT #946(MOORMAN'S RID-EZY MINERAL BLOCKS) (VET) POLYOXYPROPYLENE,POLYOXYETHYLENE BLOCK POLYMER;SKF&WYANDOTTE EXP. (VET ZOALENE, AMPROLIUM PLUS-COMBINATION W/ARSANILIC ACID & GALLIMYCIN (VET

ABBOTT LABORATORIES PHARMACEUTICAL CURRICULUM VITAE OF ABBOTT'S THERAPEUTIC COMMITTEE PRODUCTS DIV AMERICAN CYANAMID CO APP TO EA POULTRY TREATED W/SULFACHLOROPYRAZINE FOR COCCIDIOSIS (VET) NOT AN ASSIGNED NUMBER CAMBREX PROFARMACO MILANO SRL CHLORIDAZEPOXIDE (KNOW IN ITALY AS METHAMINODIAZEPOXIDE)

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4Q2012EXCEL DMF# 746 747 748 749 I 750 751 752 753 754 755 756 757 758 759 760 761 762 763 I 764 765 766 767 768 769 770 771 772 773 774 I 775 776 777 778 779 I 780 781 782 783 I A I I III IV I 2/7/1964 2/5/1964 2/5/1964 2/12/1964 I I I I I II II II 9/30/1963 1/17/1964 1/21/1964 1/24/1964 2/6/1964 I I I I I I I I I N II 1/14/1964 II II II II II II 1/7/1964 10/8/1963 12/12/1963 12/19/1963 1/10/1964 1/16/1964 1/21/1963 1/15/1964 6/21/1963 I I I I I I I I I I I I I I II II II II II I II II II II II 12/11/1963 12/26/1963 12/3/1963 12/6/1963 12/6/1963 12/6/1963 12/3/1963 12/9/1963 12/16/1963 1/6/1964 12/23/1963 1/9/1964 12/31/1963 12/24/1963 STATUS Type SUBMIT DATE I I I II II II 11/6/1963 11/12/1963 12/10/1963 11/22/1955 HOLDER WITHMORE FEEDS INC DOW CHEMICAL CO MICHIGAN DIV AJINOMOTO CO INC SUBJECT

4Q2012

TEREPHTHALIC ACID PLUS CHLORTETRACYCLINE-INVEST. PROGRAM IN FEED (VET) ZOAMIX AND ERYTHROMYCIN THIOCYANATE(VET) L-ARGININE MONOHYDROCHLORIDE

MERCK CHEM MANUFACTURING DIV MERCK DIETHYLSTILBESTROLTRADE NAME:RUMESTROL 1 AND 2(VET) & CO INC THOMPSON HAYWARD CHEMICAL CO MFGR OF DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET) MILBUR-ELLIS CO./TX AMERICAN HOME PRODUCTS AMERICAN HOME PRODUCTS AMERICAN HOME PRODUCTS AMERICAN HOME PRODUCTS AMERICAN HOME PRODUCTS AMERICAN HOME PRODUCTS ORGANON INC UPJOHN CO MERCK SHARP & DOHME RESEARCH LABS ALCON LABORATORIES INC CHEMETRON CHEMS DIV CHEMETRON CORP PRONTO ADDRESSING AND MAILING SERVICE INC CUSTOM PACKAGING IOWA STATE UNIV. NORTH CAROLINA STATE ARLIN CHEMICALS INC RM HOLLINGSHEAD CORP SOUTHWEST FLOUR AND FEED CO. CONSUMERS COOPERATIVE ASSOCIATION CHAS PFIZER AND CO INC PARKE DAVIS & CO NOT AN ASSIGNED NUMBER HESS AND CLARK CO DIV RICHARDSONMERRELL INC THE FARR COMPANY CHEMAGRO CORP STUART DIV ATLAS CHEM INDS INC-ORIG GANES CHEMICALS INC USE OF FURAZOLIDONE TO MEDICATE DUCKS(VET) DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET) BAYER 9002 (BAYER S-940)(VET) VITAMINS B-6, B-12--INTRINSIC FACTOR CONCENTRATE TABLETS CALCIUM PHENOBARBITAL DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET) INJECTABLE NOLVASAN(VET) TRICHLORFON IN SWINE (INJECTABLE) (VET)--ADD. CORRES. TO DMF-637 TENIACIDE IN DOGS, MICE AND CAS(VET) P-223 HORSE ANTHELMINTIC(VET) RENACIDEN IN DOGS AND CAS(VET) DYREX INJECTABLE IN SWINE AND HORSES(VET) PREDNISOLONE SODIUM PHOSPHATE PROMONE(MEDROXYPROGESTERONE ACETATE(VET) PRO-STREP IN SWINE(VET) DAROIL INVESTIGATORS FACILITIES, PERSONNEL & CONTROLS PROCEDURES MEDICAL ADDRESSING AMD MAILING SERVICE PACKAGING OF WALLACE LABS--ETHICAL PRODUCTS ARSANILIC ACID(VET) LACTOSTA FOR EXPERIMENTAL PURPOSES-PERMISSION TO RECIEVE (VET) MECLIZINE HCL QUATERNARY AMMONIUM SACCHARINATES DIETHYLSTILBESTROL INTERMEDIATE PREMIXES(VET) DIETHYLSTILBESTROL INTERMEDIATE PREMIXES-STILBOSOL(VET) POLYMYXIN METHANE SULFONATE FOR TREA. OF DISEASE IN POULTRY(VET) VIRAL AND BACTERIAL VACCINE

GEIGY PHARMACEUTICALS DIV CIBA GEIGY SPECIFICATIONS AND TEST METHODS FOR INERT INGREDS. CORP RHONE POULENC INC METRONIDAZOLE PLASTICOID CO FELTON WORLDWIDE INC SYNTEX SA RUBBER FORMULATIONS FELCOFIX IMITATION WILD STRAWBERRY FLAVOR T.F. #1347 GENERAL MASTER FILE --SPECIFICATIONS

Page 22

4Q2012EXCEL DMF# 784 785 786 787 I 788 789 790 791 792 793 794 795 I 796 797 I 798 799 I 800 801 802 803 804 805 806 807 I 808 809 I 810 811 812 I 813 814 815 816 817 818 819 I N N N N N A IV 10/23/1962 9/2/1964 I I II 6/8/1964 6/15/1964 6/16/1964 I 3/17/1964 6/2/1964 A I I A I A A III II I II IV 5/7/1964 1/20/1964 5/19/1964 5/13/1964 1/22/1964 5/15/1964 5/20/1964 6/1/1964 I III IV 5/8/1964 5/11/1964 I 5/6/1964 5/7/1964 I I I I N I I II 3/18/1964 4/10/1964 4/17/1964 II 2/24/1964 2/28/1964 3/2/1964 2/12/1964 STATUS Type SUBMIT DATE I I I 1/21/1964 2/18/1964 2/24/1964 2/18/1964 HOLDER PRINCETON LAB PRODS CO RHODIA INC PRECISION PACKAGING COMPANY INC WM S MERRELL CO DIV RICHARDSONMERRELL INC-ORIG ROBINSON WAGNER COMPANY INC SYNTEX SA SYNTEX SA COLUMBIA UNIV NOT AN ASSIGNED NUMBER DOW CHEMICAL CO MICHIGAN DIV PITMAN-MOORE CO DIV DOW CHEM CO DOWEX 1 X 2 RESIN --FACILS & CONTROLS METHODS AND CONTROLS SUBJECT PREPARATION & PURIFICATION OF ACTH FROM HOG PITUITARY GLANDS

4Q2012

PROPERICIAZINE-3-CYANO-10-(3'(4-HYDROXY PIPERIDINO PROPYL)PHENOTHIAZI PACKAGING FACILITIES AND CONTROLS CONTROLS AND FACILITIES LANOLIN DERIVAIVES FLUMETHASONE PARAMETHASONE PHOSPHATE DISODIUM SALT MULTIDOSE JET INJECTION DEVICE --INVESTIGATIONAL USE

DON SPARKS ASSOCIATES DIV L GORDON & CUSTOM PACKAGING OF TABLETED OR CAPSULATED MEDICATION SON INC JENSON HJ ADENYLIC ACID VICTOR M HERMELIN CO DIV K-V PHARMACAL CO UNETTE CORP DISTILLATION PROD INDS DIV EASTMAN KODAK CO CREMER OLEO GMBH AND CO KG HENKEL KGAA LILLY RES LABS DIV ELI LILLY CO SPI PHARMA INC NATL INST HLTH NCI SPENCER CHEMICAL CO DR REDDYS LABORATORIES LTD DISTILLATION PROD INDS DIV EASTMAN KODAK CO PACINI AUGUST J MD MEPROBAMATE 400MG AND 200MG PROLONGED RELEASE CAPS CUSTOM PACKAGING OF DRUG AND PHARMACEUTICAL PRODUCTS PINACYANOLE CHLORIDE MIGLYOL 812 AND 810 MANUFACTURED IN WITTEN, GERMANY. EUTANOL G; SUPPOS. BASE I & II; SUPPOS. G. CETIOL & TOXAPON CS PASTE MONITORS--CLINICAL INVESTIGATORS MANNITOL MANUFACTURED IN NEW CASTLE ,DELEAWARE DIMETHYL SULFOXIDE POLY-ETH POLYETHYLENE RESIN 1099 FLUOCINOLONE ACETONIDE ACETATE MFG IN MEXICO AND THE BAHAMAS 2,6 DICHLOROINDOPHENOL SODIUM SALT ALOE VERA ACTIVE PRINCIPLE

MERCK CHEM MANUFACTURING DIV MERCK MANUFACTURING AND CONTROL FACILITIES A RAHWAY, NJ & CO INC PHARMACHEM CORP MFGR OF LOW MOLECULAR WEIGHT DEXTRAN POWDER SYNTEX SA WADLEY INSTITUTES OF MOLECULAR MEDICINE HEWITT SOAP COMPANY INC NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER FIRMENICH INC FLAVOR FORMULAS MFGR CONTROLS-50% CHLORMADINONE ACETATE TRITURATION IN LACTOSE USP INFORMATION $ METHODS DETERGENT CLEANSING BAR

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4Q2012EXCEL DMF# 820 821 I 822 823 824 825 826 827 828 829 830 831 832 833 834 835 836 837 838 839 840 841 842 843 844 845 846 847 848 849 850 851 852 I 853 854 855 856 I 857 858 I I I 11/5/1964 11/10/1964 I I I IV III 11/23/1964 11/5/1964 11/19/1964 12/15/1964 I I I I I I I I I A I I I I I I I I I I I N N I I I I I I I II 9/30/1964 10/6/1964 10/1/1964 10/15/1964 6/30/1964 10/28/1964 10/30/1964 11/25/1964 IV IV II IV IV II II IV III I II II 7/2/1964 7/2/1964 7/21/1964 6/25/1964 6/3/1963 9/9/1964 8/11/1964 9/3/1964 8/27/1964 8/21/1964 8/19/1964 8/7/1964 8/13/1964 9/9/1964 9/14/1964 9/14/1964 9/16/1964 9/14/1964 9/3/1964 8/28/1964 8/10/1964 STATUS Type SUBMIT DATE I 6/26/1964 6/19/1964 HOLDER CLORO-BAC PRODS INC SUBJECT

4Q2012

CHLORINE DIOXIDE; CHLORODOXINE X-2;AQUA-SAN CHLORINE DIOXIDE FORMULA.

ABBOTT LABORATORIES PHARMACEUTICAL ANTIBIOTIC M-188(MACROLIDE ANTIBIOTIC OF THE ERYTHROMYCIN GROUP) PRODUCTS DIV NYSCO LABS INC PAPAVERINE HCL-TIME RELEASE PELLETS (BULK) NYSCO LABS INC NYSCO LABS INC STEPAN COMPANY SILGAN PLASTICS CORP PARKE DAVIS DIV WARNER LAMBERT CO RP SCHERER CORP FEDERAL MAILING AND PACKAGING NYSCO LABS INC SANOFI CHIMIE RHONE-POULENC REYNAUD LTD SCHUTZ & CO SOLVAY DUPHAR BV STEPAN COMPANY STEPAN COMPANY LAWSON PACKAGING CORP JT BAKER CHEMICAL CO HENKEL KGAA STEPAN COMPANY HENKEL KGAA NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER PFIZER LABS DIV CHAS PFIZER AND CO INC ALTHIAZIDE INTERNATL CHEM & NUCLEAR PHARMS INC DRAGOCO INC EI DUPONT DE NEMOURS AND CO CHEMIRAD CORP MEADE THOMAS J WYANDOTTE CHEMS CORP-ORIG CHROMIUM-51 (HIGH SPECIFIC ACTIVITY ISOTOPE) PUR-CELLIN OIL, DRAGOCO SCIENTIFIC PERSONNEL TRIETHYLENE MELAMINETEM MARIV 240 (HIGH IODINE VALUE FISH OIL FRACT.)-S. AFRICAN PILCHARD OIL URETHANE LATEX E-204 DEXTROMETHORPHAN HYDROBROMIDE (IN BULK TIME RELEASE PELLETIZED FORM) METH & FACIL-T.R. CAP W/DEXTROMETHORPHAN,CHLORPHENIRAMINE&PHENYLEPHRIN POLYGLYCEROLS & ESTERS OF FATY ACIDS HIGH & LOW DENSITY POLYETHYLENE EPOXY RESIN FROMULATION #LA-16 METHODS, FACILS & CONTRLS HARDSHELL GELATIN CAPS METHODS, FACILITIES AND CONTROLS PAPAVERINE HCL-METHODS, FACIL,CONTRL-IN MFGR OF T.R. CAPS TRIMEPRIMINE(TRIMIPRAMINE-USAN) METHODS FACILS & CONTROLS --REGARDING MFGR OF RP 8599 COUGH SYRUP FLAVOR R 446 MESO-INOSITOL HEXANICOTINATE LACTULOSE SOLUTION VEGETABLE OIL 1400 NEOBEE O HANDLING & PACKAGING OF DRUG PRODS IN PHARMACEUTICAL PROGRAMS ETHYL DIBUNATE (PRODUCTION) DEPLASTOL AR 13026 AND AR 13027 NASUNA A AND NASUNA B

ABBOTT LABORATORIES PHARMACEUTICAL IRON-58 STERILE SOLUTION PRODUCTS DIV JT BAKER CHEMICAL CO CHLOROTRIANISENE HOSPIRA ASHLAND PARKE DAVIS & CO COLONIAL SUGARS COMPANY SUCRO CHEMICAL DIV JT BAKER CHEMICAL CO 3M PHARMS FAULTLESS COMPOUNDS PROCEDURES SUCROSE MONOPALMITATE AZACYCLONOL HCL MANUFACTURING AND CONTROL FACILITIES AND PERSONNEL

Page 24

4Q2012EXCEL DMF# 859 860 861 862 863 864 865 866 867 868 869 870 871 872 873 874 875 876 877 I 878 879 880 881 882 883 884 885 A 886 887 888 889 890 891 892 893 894 895 896 I 897 I IV 6/9/1965 I I I I I I I I I I II IV I 4/19/1965 4/19/1965 4/29/1965 5/6/1965 5/6/1965 5/6/1965 5/12/1965 5/13/1965 5/17/1965 6/1/1965 6/10/1965 I A I A I A I III II II III 3/2/1965 3/15/1965 3/5/1965 1/2/1965 3/8/1965 3/18/1965 3/31/1965 3/29/1965 STATUS Type SUBMIT DATE I I I I A I N I I I I I N I I I I I II 1/7/1965 2/15/1965 1/15/1990 9/24/1964 2/26/1965 2/24/1965 II II 12/2/1964 12/22/1964 1/14/1965 1/14/1965 1/5/1965 II II 12/10/1964 6/26/1967 12/22/1964 12/16/1964 11/23/1964 12/21/1964 HOLDER WORTHINGTON BIOCHEM CORP SCHUYLKILL CHEM CO VAN DYK AND CO INC WHEATON SCIENTIFIC ARCH CHEMICALS INC PILLSBURY CO NOT AN ASSIGNED NUMBER CHRISTIAN BRUNNENGRABER AND CO SYNTEX SA SYNTEX SA FINE ORGANICS INC ROHM AND HAAS CO NOT AN ASSIGNED NUMBER SCHIEFFELIN AND CO PFISTER CHEMICAL COMPANY INC STOCKHOLMS GUMMIINDUSTRI AB GARRETT LABS INC MYERS-CARTER LABS INC FACILS, MFG, PROCESSING AND PACKAGING FLUOROPHENE RUBBER STOPPERS QUALITY 2213 BACITRACIN AEROSOL SPRAY FACILS., CONTROLS AND PERSONNEL & PROCEDS. METHOCARBAMOL FLUMETHASONE FLUMETHASONE ACETATE TEMASEPT III RHOZYME 41 CONCENTRATE SUBJECT BETA LIVER FRACTION -B ALLANTOIN AND THE ALUMINUM ALLANTOINATES CERAPHYL 28 (CETYL LACTATE) GLASS MANUF. PROCEDURES ZINC OMADINE MANUFACTURED IN ROCHESTER NY POLYTETRAN (BRAND OF BETA-GLUCAN)

4Q2012

PHILADELPHIA LABS INC DIV PHILA PHARMS MANUFACTURING AND CONTROL FOR PRODUCTION OF MEPROBAMATE AND COSMETICS INC DAY BALDWIN INC FACILITIES AND PERSONNEL TOMPKINS PHARMACEUTICAL RUBBER PACKAGING COMPONENTS INC CAMBREX PROFARMACO MILANO SRL BF GOODRICH COMPANY CAMBREX PROFARMACO MILANO SRL US PUBLIC HEALTH SERV EQUISTAR CHEMICALS LP SUB LYONDELLBASELL INOLEX CHEMICAL CO CROWN ZELLERBACH CORP NYSCO LABS INC SHELL CHEM CO SHELL CHEM CO SHELL CHEM CO RHODIA INC ER SQUIBB AND SONS INC NYSCO LABS INC GEIGY CHEM CORP VICTOR M HERMELIN CO DIV K-V PHARMACAL CO HENKEL KGAA RUBBER FORMULATIONS METHODS, CONTROLS AND FACILITIES HYDROCHLOROTHIAZIDE MANUFACTURED IN MILAN, ITALY. CARBOSET RESINS CHLOROTHIAZIDE INVESTIGATOR INFO POLYMERS FOR USE IN PACKAGING METHODS, FACILS & CONTROLS DIMETHYL SULFOXIDE(DMSO)FACILITIES AND CONTROLS FACILITIES AND CONTROLS HUMAN STUDIES FOR NEW DRUGS INVESTIGATORS FOR HUMAN STUDIES FACILITIES-GENERAL MFGR PROTOCOL AND RAW MATERIAL CONTROLS RP 9965 SILICONE FLUIDS DIPHENHYDRAMINE HCL -PELLETS IRGASAN CH 3549 PETN - BUTABARBITAL DEHYMULS E AND DEHYMULS K

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4Q2012EXCEL DMF# 898 899 900 901 902 903 I 904 905 906 907 908 909 910 911 912 I 913 914 915 916 917 918 I 919 920 921 922 923 924 925 926 927 928 I 929 930 931 932 933 934 I I I A I I III IV II II I 12/9/1965 12/3/1965 12/15/1965 12/16/1965 12/27/1965 12/8/1965 PCM CORP CUSTOM PACKAGING HOSPIRA INC WR GRACE ELI LILLY AND CO I I I I I I I I I II I 11/9/1965 11/17/1965 11/13/1965 11/15/1965 11/23/1965 11/30/1965 11/24/1965 12/8/1965 12/8/1965 12/9/1965 I I I A I V II 9/7/1965 9/15/1965 9/10/1965 9/24/1965 9/24/1965 10/11/1965 I I I I I I I I II IV IV 8/24/1965 8/23/1965 8/23/1965 8/25/1965 8/28/1965 9/2/1965 9/2/1965 9/2/1965 7/6/1965 STATUS Type SUBMIT DATE I I I I I III II 6/9/1965 6/24/1965 7/19/1965 7/22/1965 7/29/1965 8/13/1965 HOLDER MILAN PHARMACEUTICALS INC MURRAY RODERICK MD AMERICAN NATIONAL CAN CO ORGANON INC P-L BIOCHEMS INC WALLACE LABORATORIES DIV CARTER WALLACE INC DOW CHEMICAL CO MICHIGAN DIV GD SEARLE AND CO HENKEL KGAA PACIFIC BIOCHEM INC SYNTEX SA UNGERER AND CO CONNAUGHT MED RES LABS JUNICE LABS INC FIRST TEXAS PHARMACEUTICALS INC SUB SCHERER LABS INC JUNICE LABS INC PHARMA-RES CANADA LTD KLINE NATHAN S MD CIBA CORP CROWN ZELLERBACH CORP WINTHROP PHARMACEUTICALS DIV STERLING DRUG INC PARKE DAVIS & CO STIEFEL LABORATORIES INC CARRON PRODUCTS CO SB PENICK AND CO ORIG OWENS ILLINOIS INC BROCKWAY GLASS CO INC EJ TRUM INC NORTON CO EURAND AMERICA INC BOEHRINGER MANNHEIM GMBH SUBJECT MEPROBAMATE TABLETS IND LISTING DIV. OF BIOLOGICS STANDARDS POLYOLEFIN PRODUCTS (C-70 SERIES) MESTRANOL DIPHOSPHOPYRIDINE NUCLEOTIDE (DPN) MEPROBAMATE POWDER-WITH TRACER TEFLURANE METHODS, FACILITIES & CONTROLS DEHYDAG-PRODUCTS1. DEHYDAG WAX O METHODS & FACILITIES DIMETHISTERONE COMPOUND FLAVOR #5218 PHENOXALID(COMPOUND #377) PROMETHAZINE HYDROCHLORIDE U.S.P. (MANUF. & SPECIFICATIONS) MANUFACTUER PROCEDURES CHLORPROMAZINE HYDROCHLORIDE U.S.P. FLOOR PLAN ---- EQUIPMENT ---- PERSONNEL RESEARCH INFORMATION TRICLOSAN TOXICOLOGY INFORMATION TRICHLOROLEVULINIC ACID (TCLA) IN POLYETHYLENE LINED CONTAINERS COMPOUND 904 GYNECOLOGY BOOK SULFOXYL 342 RED NATURAL RUBBER COMPOUNDS AND P & H COATING QUERCETIN

4Q2012

PROJECT NO. 84258 EXTRACTION STUDIES FROM TIN OXIDE COATED BOTTLES THE CHEMICAL DURABILITY OF F-GLASS PACKAGING CARTON MANUFACTURING MAILING HISTORY AND PROCEDURES ENCAPSULATION MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. PACKAGING METHODS AND FACILITIES OPERATION AND PROCEDURE PLIA-LITER (TM) BAGS SYLOID - SILICA PRODUCTS (SILICA GEL) AMPOULES SODIUM THIOCYANATE, INJECTION COMPOUND #23206

AYERST LABORATORIES INC DIV AMERICAN PREMARIN (CONJUGATED ESTROGENS-EQUINE) HOME PRODUCTS CORP

Page 26

4Q2012EXCEL DMF# 935 936 937 938 939 940 941 942 I 943 944 I 945 946 947 948 949 950 951 952 953 954 955 956 957 958 959 960 961 962 963 I 964 965 966 967 968 969 970 971 972 973 I I I A I I I I I I I IV II 5/13/1966 6/7/1966 6/6/1966 12/21/1965 6/20/1966 6/22/1966 6/23/1966 6/27/1966 6/27/1966 6/22/1966 SCHERING AG NORTH AMERICAN PHILIPS CO INC MILES PHARMACEUTICAL DIV MILES INC COLORCON INC DAVIS-EDWARDS PHARMACAL CORP ER SQUIBB AND SONS INC DOW CORNING CORP AMERICAN CYANAMID CO ARMOUR PHARMACEUTICAL CO HENKEL KGAA MESTRANOL MEBEVERINE HYDROCHLORIDE CURRICULUM VITAE (PERSONNEL) POLYVINYL ACETATE PHTHALATE METHODS, FACILITIES, CONTROLS AND PACKAGING OF DRUGS I I I I I I I A I I I I I I I I I I I I III III IV 3/11/1966 10/28/1965 2/2/1966 3/16/1966 3/18/1966 3/15/1966 3/30/1966 4/6/1966 4/1/1966 1/6/1966 4/19/1966 4/19/1966 4/22/1966 4/26/1966 5/6/1966 5/11/1966 5/11/1966 5/13/1966 5/5/1966 I 2/28/1966 2/25/1966 HENKEL KGAA WARNER LAMBERT CO PHARMACEUTICAL RESEARCH DIVISION HUMBLE OIL AND REFINING CO GUARDIAN CHEMICAL CORP STANDARD AROMATICS INC ROBIN PHARMACAL CORP-ORIG DOW CHEMICAL CO MICHIGAN DIV CF BOEHRING AND SOEHNE GMBH RHODIA INC KLOCKNER PENTAPLAST OF AMERICA INC CP HALL CO NATL INST HLTH CLINCL CTR PHARMACY FISONS PHARM LTD TRI X CORP ER SQUIBB AND SONS INC SYNTEX (USA) INC GANES CHEMICALS INC JT BAKER CHEMICAL CO FISHER STEVENS INTRA PRODS DIV DURR PRODS STATUS Type SUBMIT DATE I I I I I I I I I III 1/11/1966 1/26/1966 2/1/1966 2/4/1966 2/11/1966 2/21/1966 2/17/1966 2/28/1966 HOLDER FINE ORGANICS INC BERLIN LABS INC TUBED CHEMICALS CORP EI DUPONT DE NEMOURS AND CO DIAMOND ALKALI CO VYPAK CORP CLARK ONIELL INC ARMSTRONG LABORATORIES INC SUBJECT TEMASEPT IV DMSO INFORMATION FACILITIES & CONTROLS

4Q2012

POLYETHYLENE FILM TYPE A-101 (DRUG PACKAGING) AND MYLAR POLYESTER FILM CP 519-2 POLYVINYL CHLORIDE RESINPOLYVINYL CHLORIDE RESIN, CP 519-2 P-2, P-6 & P-7 POLYVINYL CHLORIDE COMPOUNDS ASSEMBLING AND MAILING OF DRUG SAMPLE AND LITERAURE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WEST ROXBURY, MASSACHUSETTS. PRESERVAIVE C INVESTIGATIONAL NEWN DRUG LISTINGS ISOPAR SURTENOL IMITATION FLAVOR MANUFACTURING AND PROCEDURES ETHOXYLATED POLYETHYLENIMINE, MONTREK600E NICOTINAMIDE-ADENINE-DINUCLEOTIDENADDPN CLOREXOLONE GENOTHERM TYPE PVC FILMS PARAPLEX G-50(THIS DFORMERLY HELD BY ROHM AND HAAS CO) LISTING ----DIV BIOLOGICS NOTICES (IND'S) LOMODEX (DEXTRAN 40 INJECTION) FACILITIES AND CONTROLS FACILITIES AND CONTROLSPERSONNEL FOR MANUFACTURE AND CONTROL FACILITIES AND CONTROLS EBNZOMETHAMINE CHLORIDE CLOMIPHENE CITRATE DESCRIPTION OF FACILITIESPROCEDURESCONTROLSPERSONNEL CONTROLS AND FACILITIES

CALGON CORP DIV MERCK & COMPANY INC BIOCHEK 60

SUMMARIES OF THE BACKGROUND & QUALIFICATION OF INVEST & MONITORS DOW CORNING (R) 555 FLUID CYTOX (R) 2013 DODECYLGUANIDINE HYDROCHLORIDE LYOSZYME TEXAMID S 058 AND CUTINA OR

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4Q2012EXCEL DMF# 974 975 976 977 978 I 979 980 981 982 983 984 985 986 987 988 989 990 991 992 993 994 995 I 996 997 998 999 1000 1001 1002 1003 1004 1005 I 1006 1007 1008 1009 1010 1011 1012 I I A I I I I III II 11/4/1966 11/1/1966 10/31/1966 11/10/1966 5/20/1965 11/21/1966 11/18/1966 I I I I I I I I I II V I I 8/22/1966 9/20/1966 9/21/1966 9/14/1966 9/15/1966 9/16/1966 10/13/1966 10/19/1966 10/21/1966 10/28/1966 I I I I I I I I I I A I I N I I III 9/15/1966 9/22/1966 9/7/1966 I V III I III II III I III IV 7/12/1966 7/16/1966 7/22/1966 7/25/1966 8/1/1966 8/10/1966 8/15/1966 8/29/1966 2/11/1966 9/14/1966 8/25/1966 10/1/1966 9/3/1966 STATUS Type SUBMIT DATE I I I A II II III II 6/28/1966 7/6/1966 7/11/1966 7/1/1966 7/13/1966 HOLDER SHELTERED EMPLOYMENT SERVICES INC RHODIA INC ATOMIC ENERGY OF CANADA LTD BAXTER HEALTHCARE CORP VICTOR M HERMELIN CO DIV K-V PHARMACAL CO HELVOET PHARMA SHIONOGI QUALICAPS INC LABORATORIES GLAXO EVANS MARION LABORATORIES INC PHARMACIA FINE CHEMS REYNOLDS PACKAGING LLC NYSCO LABS INC VCF PACKAGING FILMS INC SERUMWERK BASEL AG ALCON LABORATORIES INC HOSPIRA HOFFMANN LA ROCHE INC HOFFMANN LA ROCHE INC NOT AN ASSIGNED NUMBER BECTON DICKINSON AND CO HENKEL KGAA IVERS-LEE MIDWEST CO INC DIV BECTONDICKINSON AND CO HENKEL KGAA LEMMON CO MALLINCKRODT INC EJ TRUM INC GENERAL FOODS CORP SLOAN-KETTERING INST CANCER RES NYSCO LABS INC NYSCO LABS INC TROPONWERKE GMBH CO KG SCHERING CORP SUB SCHERING PLOUGH CORP NYSCO LABS INC HOFFMANN LA ROCHE INC HENKEL CORP BARR-STALFORT DIV PITTWAY CORP COLONIAL SUGAR REFINING CO LTD HENKEL KGAA DRUG & ALLIED PRODUCTS GUILD INC PARENTOPAK PHARMACEUTICAL SYRINGE EDENOL BS (STEARIC ACID BUTYL ESTER) PACKAGING FACILITIES AND CONTROLS LUBRICANTS FOR PLASTICS FACILITIES, EQUIPMENT AND CONTROLS FACILITIES, PROCEDURES AND PERSONNEL FACILITIES AND CONTROLS MONSODIUM DIHYDROGEN PHOSPHATE CLINICAL INVESTIGATORS FILE. PSEUDOEPHEDRINE HCL TIMED RELEASE PELLETS PHENOBARBITAL TIMED RELEASE PELLETS METHAQUALONE BASE AND HCL THIHEXINOL METHYLBROMIDE PAVABID-PB TIMED RELEASE CAPSULES COMPOSITION & MFGR OF INJECTABLE SOLUTION OF HEPARINOID RO 1-8307 GELVA? MULTIPOLYMER RESIN EMULSIONS (GME) AEROSOL PRODUCTION OPERATIONS CLINICAL TESTING OF ANTI-CARIES AGENTS FATY ACIDS EFFECTIVENESS OF ANTIBIOTIC DRUGS SUBJECT FACILITIES, CONTROLS AND PROCEDURES PENTAMIDINE ISETHIONATE RADIOISOTOPE MASTER FILE POLYVINYL CHLORIDE PLASTIC (PL-146) NITROGLYCERIN FORMULAS AND INGREDIENTS FORMULA INDENTIFICATION CODE--IDENTI-CODE INDEX CARRAGRRIN DERIVAIVE C.16 FACILITIES AND CONTROLS DEAE-SEPHADEX (C-800 074) FOIL-VINYL SPECIFICATION BROMODIPHENHYDRAMINE HYDROCHLORIDE CAST VINYL FILMS C-102 & C-105 FORMERLY HELD BY CADILLAC PLASTIC) TOQUILONE COMPOSITUM FACILITIES AND CONTROLS STERILE MANUFACTURING FACILITY IN CLAYTON NC PACKAGING MATERIALS RAW MATERIAL

4Q2012

Page 28

4Q2012EXCEL DMF# 1013 1014 1015 1016 1017 1018 1019 I 1020 1021 1022 1023 1024 1025 1026 1027 1028 1029 1030 1031 1032 1033 1034 1035 1036 1037 1038 1039 1040 1041 1042 1043 1044 I 1045 1046 1047 1048 1049 1050 1051 I I I I A A A III II II II II 3/28/1967 3/27/1967 3/31/1967 3/24/1967 3/21/1967 3/22/1967 3/23/1967 I I I A I I I I I I I I I I I I I I I I I I I I II II II 3/9/1967 3/7/1967 3/15/1967 3/17/1967 3/27/1967 3/29/1967 II II III II 1/13/1967 1/12/1967 1/19/1967 1/16/1967 12/6/1966 1/31/1967 2/1/1967 2/2/1967 2/6/1967 2/6/1967 2/6/1967 2/6/1967 2/9/1967 3/10/1966 2/16/1967 2/16/1967 2/2/1967 3/1/1967 STATUS Type SUBMIT DATE I I I A I I IV II III 12/13/1966 12/14/1966 12/2/1966 12/14/1966 12/22/1966 1/5/1967 1/5/1967 HOLDER DOWNINGTON PAPER CO ER SQUIBB AND SONS INC SCHERING AG CHEVRON PHILLIPS CHEMICAL CO LP GENERAL ANILINE AND FILM CORP ICI AMERICAS INC SUBJECT PROCEDURE FOR CONTRACT PACKAGING OF DRUGS PATIENT STARTER PACKAGES AMIDOTRIZOIC ACID(UROGRAFIN ACID) MARLEX RESINS-POLYOLEFINS FOR DRUG PACKAGING USE UVINUL N-539 PGAC-112(THIS DFORMERLY HELD BY CHATEM CHEMICALS)

4Q2012

CIBA PHARMACEUTICAL CO DIV CIBA GEIGY ORISUL TABS, SUSPENSION & SUSPENSION FOR CHILDREN CORP GEIGY CO SA FACILITIES AND PERSONNEL CONTROL OPERATIONS,MANUFACTURING OPERATIONS NYSCO LABS INC CHAS PFIZER AND CO INC OXYVINYLS LP MURRAY E CORN ASSOC INC VPI MIRREX CORP ICI AMERICAS INC GENERAL ATOMIC FLUORITAB CORP FLUORITAB CORP FLUORITAB CORP P-L BIOCHEMS INC MICRO CHEMS LTD ER SQUIBB AND SONS INC KAROLINSKA INST CHATTEM DRUG & CHEMICAL COMPANY PARKE DAVIS & CO HOFFMANN LA ROCHE INC UNKNOWN NAFTONE INC ATLAS CHEMICAL INDUSTRIES INC VALE CHEMICAL COMPANY INC MONSANTO COMPANY OLIN MATHIESON CHEM CORP LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO FINE ORGANICS INC PHILLIPS PETROLEUM CO LILLY RESEARCH LABORATORIES GANES CHEMICALS INC SIEGFRIED USA LLC SIEGFRIED USA LLC SIEGFRIED USA LLC 6-AMINOCAPROIC ACID STANDARD DRUG MIXTURE NO. 16 (10% NITROGLYCERIN-LACTOSE MIXTURE) FACILITIES, METHODS AND PERSONNEL POLYVINYL CHLORIDE CONTAINERS SODIUM OMADINE SPECTRASORB UV 531 ALLANTOIN MARLEX 0202 POLYOLEFIN RESIN POLYVINYL CHLORIDE CONTAINERS BUTABARBITAL PHENOBARBITAL SECOBARBITAL SODIUM USP AMOBARBITAL ISOSORBIDE DINITRATE TIMED RELEASE PELLETS METAMINE POLYVINYL CHLORIDE TETRACYCLINE HCL S.R. RP 16,091 (10-METHYL-2-PHENOTHIAZINYL) ACETIC ACID STANDARD DRUG MIXTURE NO. 23 (20% PETN) ISOTOPE RESEARCH PROGRAM DURABONE #5 TABLETS (11.25MG. SODIUMFLUORIDE) DURABONE #10 (22.5MG SODIUM FLUORIDE) TABLETS DURABONE # 25 (56.25MG SODIUM FLUORIDE) TABLETS TRIFLUOROTHYMIDINE (F3TDR), FACILITIES AND CONTROLS MEPROBAMATE N.F. LISTING OF INDS CHOLECYSTOKININ-PANCREOZYMIN --CCK-PZ ALUMINUM CHLORHYDROXIDE COMPLEX ACH-TYPE A-23 BENADRYL POWDER PROTAMINE HCL, RO 6-1588/1

Page 29

4Q2012EXCEL DMF# 1052 1053 1054 I 1055 1056 1057 I 1058 1059 1060 1061 1062 1063 1064 1065 1066 1067 I 1068 1069 1070 1071 1072 1073 I 1074 1075 I 1076 1077 1078 1079 1080 I 1081 1082 1083 1084 1085 1086 1087 A I I I I I I II II I III 9/6/1967 9/15/1967 9/25/1967 9/13/1967 10/4/1967 10/6/1967 10/18/1967 A I I I II II 8/15/1967 8/25/1967 8/28/1967 9/6/1967 9/7/1967 I II 6/27/1967 8/7/1967 I I I I I II 5/6/1967 7/17/1967 6/22/1967 7/19/1967 7/26/1967 8/4/1967 I I A I I I I I I II I II I II II III 5/2/1967 5/10/1967 5/2/1967 5/2/1967 5/19/1967 5/29/1967 6/6/1967 6/21/1967 6/21/1967 6/29/1967 I I 4/25/1967 4/26/1967 5/2/1967 STATUS Type SUBMIT DATE I I I 4/3/1967 4/17/1967 4/21/1967 HOLDER DOW CHEMICAL CO MICHIGAN DIV CHATTEM DRUG & CHEMICAL COMPANY FUJISAWA PHARMACEUTICAL COMPANY LTD FRANK H FLEER CORP MACLIN CO LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO ALLIED CHEM CORP MICRO CHEMS LTD KLOCKNER PENTAPLAST OF AMERICA INC ALLIED CHEM CORP SYNTEX CORP CALBIOCHEM-BEHRING CORP FERRING AB ICI PHARMA SYNTEX CHEMICALS INC ARAPAHOE CHEMS INC DIV SYNTEX LABS INC WINGENROTH LEONORA MILES INC IMPERIAL CHEMICAL INDUSTRIES PLC PURDUE FREDERICK CO EI DUPONT DE NEMOURS AND CO SUBJECT UNS-TETRAFLUOROETHANE ALUMINUM CHLORHYDROXIDE COMPLEX, TYPE A-34 SYNTHESIS OF PYRROINITRIN CHEWING GUM COMPOUND MACLIN COMPOUND VM-1921---POLYVINYL CHLORIDE ACETATE DICHLOROMETHOTREXATE CP 014 COPOLYMER HYDROCHLOROTHIAZIDE USP MIRREX MCFD RIGID VINYL SHEET.PRODS X-2002M PVC BOTTLE BLOWING RESIN FREEPORT FACILITIES DOPAMINE HCL ACTH STANDARD DRUG MIXTURE NO. 22 GENERAL MASTER FILE (THIS DFORMERLY ARAPAHOE CHEMICALS, INC) DIMETHYL SULFOXIDE JOST STERILE PACK AND PROCESS METHOXYPHENAMINE HCL COOMASSIE BLUE CLINICAL INVESTIGATORS SR-87M GENERATORS

4Q2012

AMOCO CHEMS CORP AFFILIATE AMERICAN INDOPOL POLYBUTENES OIL CO SOLVAY PHARMACEUTICALS MANUFACTURING CONTROL INFORMATION FOR--LITHIUM CARBONATE BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO AJINOMOTO CO INC ER SQUIBB AND SONS INC NORWICH PHARMACAL CO NYSCO LABS INC PHARMACEUTICAL FLAVOR CLINIC DIV OF FOOTE & JENKS BILCARE RESEARCH GMBH NYSCO LABS INC SYNTEX USA INC SYNTEX USA INC AMERICAN CYANAMID CO PURDUE FREDERICK CO RICHARDSON-MERRELL INC NEOCARZINOSTAIN AMINO ACID PRODUCTS MANUFACTURE OF HYDROXYUREA MANUFACTURING AND QUALITY CONTROL DEXTRO-AMPHETAMINE SULFATE PHARMACEUTICAL FLAVORS PVC FILM MANUFACTURED IN SCHLOSSMATENSTRASSE 2, GERMANY. PENITE TIMED RELEASE CAPSULES RESEARCH STEROIDS NORETHINDRONE ACETATE CONSUMER PRODUCTS DIVISION MANUFACTURE AND CONTROL OPERATIONS DIETHYLPROPION HCL

Page 30

4Q2012EXCEL DMF# 1088 1089 I 1090 1091 I 1092 1093 1094 1095 1096 1097 1098 1099 1100 1101 1102 1103 1104 I 1105 I 1106 1107 I 1108 I 1109 1110 1111 I 1112 1113 1114 1115 1116 1117 1118 1119 1120 1121 I 1122 I II 1/17/1968 I I I A I I I I I IV II II II II III 12/20/1967 12/20/1967 1/2/1968 12/28/1967 1/2/1968 1/18/1967 12/18/1967 1/3/1968 1/4/1968 1/5/1968 I I IV 12/18/1967 12/18/1967 12/12/1967 12/15/1967 I 12/11/1967 12/11/1967 12/8/1967 I I I I I I I I I A I I II II IV III I III II 10/24/1967 10/25/1967 10/27/1967 11/2/1967 11/8/1967 11/9/1967 11/17/1967 11/24/1967 11/27/1967 9/11/1967 11/30/1967 12/1/1967 12/6/1967 I 10/19/1967 10/23/1967 STATUS Type SUBMIT DATE I 10/17/1967 10/17/1967 HOLDER RICHARDSON-MERRELL INC SUBJECT DIETHYLPROPION HCL WITH TARTARIC ACID

4Q2012

ABBOTT LABORATORIES PHARMACEUTICAL MEPROBAMATE PRODUCTS DIV NYSCO LABS INC BUTA-PENITE TIMED RELEASE CAPSULES VICTOR M HERMELIN CO DIV K-V PHARMACAL CO CENTURY PACKAGING CORP SCHERING AG CHEMDEX INC SF DURST AND CO INC DELAWARE CITY PLASTICS CORP UNITED STATES DEPARTMENT ENERGY ER SQUIBB AND SONS INC HERCULES INC STANDARD PHARMACAL CORP PECHINEY PLASTIC PACKAGING INC RICHLYN LABORATORIES INC PHILLIPS FILMS COMPANY INC PETN 80MG SUSTAINED RELEASE CAPSULES PACKAGING FACILITIES AND CONTROLS ESTRADIOL ENANTHATE IRON HY-DEX HUMAN USE DEXAMETHASONE DIAMOND PVC-500 RESIN TIN-113/INDIUM-113M (DFORMERLY HELD BY UNION CARBIDE CORP) PLASTIBASE (SQUIBB PLASTICIZED HYDROCARBON GEL) STAYBELITE RESIN MANUFACTURING FACILITIES AND CONTROLS PACKAGING FILMS FACILITIES, PERSONNEL AND CONTROLS IN CONNECTION WITH NEW DRUGS ELASTOTHERM F. FILM

VICTOR M HERMELIN CO DIV K-V DRISTAN CAPSULES PHARMACAL CO AYERST LABORATORIES INC DIV AMERICAN CF-100 OINTMENT HOME PRODUCTS CORP CONTINENTAL CAN COMPANY 104 CLS CAN ENAMEL DISTILLATION PROD INDS DIV EASTMAN KODAK CO DAVIES ROSE HOYT PHARM DIV KENDALL CO TENNESSEE EASTMAN CO-ORIG SCHERING AG INTERNATIONAL FLAVORS AND FRAGRANCES INC VALSPAR CORP VALSPAR CORP CHATTEM DRUG & CHEMICAL COMPANY EVONIK DEGUSSA CORP UNITED STATES DEPARTMENT ENERGY UNITED STATES DEPARTMENT ENERGY UNITED STATES DEPARTMENT ENERGY U.S. DEPARTMENT OF ENERGY REYNAUD LTD ETHYL PHENYLUNDECYLATE (EASTMAN 7045) MANUFACTURING, PACKAGING AND CONTROL PROCEDURES METHYL 2-CYANOACRYLATE DROXONE FLAVORS AS MANUFACTURED IN THE EMERSON, NEW JERSEY FACILITY. MOBILE PACKAGING COATING FORMULATION S-988-025 MOBILE PACKAGING COATING FORMULATION S-7007-006 ALUMINUM CHLORHYDROXIDE COMPLEX AEROSIL CESIUM-131 (DFORMERLY HELD BY UNION CARBIDE CORP) MERCURY-197 (DFORMERLY HELD BY UNION CARBIDE CORP) MERCURY-203 (DFORMERLY HELD BY UNION CARBIDE CORP) IODINE-123 (DFORMERLY HELD BY UNION CARBIDE CORP) REYNO CLOUD

GLENBROOK LABORATORIES DIV STERLING GENERAL DESCRIPTION OF FACILITIES, MANUFACTURING AND CONTROLS DRUG INC UNITED STATES DEPARTMENT ENERGY MOLYBDENUM-99-P-2 (DFORMERLY HELD BY UNION CARBIDE CORP)

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4Q2012EXCEL DMF# 1123 1124 1125 I 1126 1127 1128 1129 I 1130 1131 1132 1133 1134 1135 1136 1137 1138 1139 1140 I 1141 1142 1143 I 1144 1145 A 1146 1147 I 1148 1149 1150 1151 I 1152 1153 1154 1155 1156 1157 1158 I I I I A I I III I I II 3/11/1968 3/11/1968 3/15/1968 3/8/1968 2/28/1968 3/21/1968 3/7/1968 I I I I 3/7/1968 3/7/1968 3/8/1968 3/8/1968 N 3/5/1968 I III 2/16/1968 2/8/1968 MONSANTO COMPANY DEWEY AND ALMY CHEM DIV WR GRACE AND CO NOT AN ASSIGNED NUMBER VICTOR M HERMELIN CO DIV K-V PHARMACAL CO UNION CARBIDE CORPORATION UNION CARBIDE CORPORATION GENERAL ELECTRIC CO VICTOR M HERMELIN CO DIV K-V PHARMACAL CO UNITED STATES DEPARTMENT ENERGY HARTE & COMPANY INC PHARMACAPS INC GENERAL ELECTRIC CO AMCOR FLEXIBLES INC STRIP-PACK CO KIMBERLY CLARK CORP I I III II I 2/9/1968 2/9/1968 2/14/1968 I I I I I I I I I I II II II II II II II 1/22/1968 1/25/1968 1/24/1968 1/24/1968 1/31/1968 1/30/1968 2/1/1968 1/30/1968 2/2/1968 2/5/1968 2/1/1968 I I I 1/15/1968 1/15/1968 1/16/1968 1/18/1968 EI DUPONT DE NEMOURS AND CO CILAG CHEMIE AG ROUSSEL CORPORATION STATUS Type SUBMIT DATE I I II II I 1/17/1968 1/17/1968 1/10/1968 HOLDER UNITED STATES DEPARTMENT ENERGY U.S. DEPARTMENT OF ENERGY HEXAGON LABORATORIES INC SUBJECT MOLYBDENUM-99-P-1 (DFORMERLY HELD BY UNION CARBIDE CORP) PHOSPHORUS-32 (DFORMERLY HELD BY UNION CARBIDE CORP) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES . IN-113M GENERATORS 3-AMINOOPROPIONITRILE FUMARATE MAHAQUALONE

4Q2012

WARNER CHILCOTT DIV WARNER LAMBERT SPECIAL MATERIALS CO HOECHST CELANESE CORP BLOOD PLASMA TUBES TYPE BLU 1 AND TF70 TROJAN POWDER CO UNITED STATES DEPARTMENT ENERGY MALLINCKRODT INC AMERICAN CYANAMID CO UNITED STATES DEPARTMENT ENERGY UNITED STATES DEPARTMENT ENERGY U.S. DEPARTMENT OF ENERGY INTERNATL CHEM & NUCLEAR PHARMS INC SCHWARTZ MANN MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC VALSPAR CORP DBI INC NEPERA INC PENTAERYTHRITOL TETRANITRATE (PETN) CHROMIUM-51 (DFORMERLY HELD BY UNION CARBIDE CORP) DIARIZOIC ACID VITAMIN B 12 WITH INTRINSIC CONCENTRATE STRONTIUM-85 (DFORMERLY HELD BY UNION CARBIDE CORP) IRON-59 (DFORMERLY HELD BY UNION CARBIDE CORP) IODINE-131 (DFORMERLY HELD BY UNION CARBIDE CORP) 5-FLUOROURACIL TRITURATED THYMIDINE IN STERILE PYROGEN-FREE SOLUTION QUALIFICATIONS OF RESEARCH PERSONNEL CONTAINER COATING, PRE-STRIPS GOLD ENAMEL (#563-803) DEXAMETHASONE ACETATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. ETHANE-1-HYDROXY-1,1-DIHOSPHONIC ACID DISODIUM SALT DAREX CAN SEALING COMPOUND

PENTRITOL (PENTAERYTHRITOL TETRABUTRATE) TEMPULES 30MG C.R.C BAKELITE BRAND VGAB-0613 NATURAL 7 VINYL SHEET BAKELITE BRAND VGAB-0607 NATURAL 7 VINYL SHEET MOLYBDENUM-99 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. MOLYBDENUM-99-P-3 (DFORMERLY HELD BY UNION CARBIDE CORP) PVC RESIN COMPOUNDS METHODS, FACILITIES AND CONTROLS MERCURY-197 METALAM AND MARAFLEX 7F-452 MANUFACTURE & CONTROL PROCEDURES FOR PACKAGING KIMFOL BRAND POLYCARBONATE FILM

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4Q2012EXCEL DMF# 1159 I 1160 1161 1162 I 1163 1164 1165 1166 1167 1168 1169 A 1170 1171 I 1172 1173 1174 1175 1176 1177 1178 1179 1180 1181 1182 1183 1184 1185 1186 1187 1188 1189 1190 1191 1192 I 1193 1194 1195 I I I III IV 5/31/1968 6/12/1968 6/17/1968 I I I I I I I I A I I I I I A I I I I I II II III I III IV II II II II 4/22/1968 4/24/1968 4/24/1968 4/24/1968 4/24/1968 5/6/1968 5/6/1968 4/24/1968 5/8/1968 5/9/1968 5/13/1968 5/7/1968 5/7/1968 5/13/1968 5/10/1968 5/13/1968 5/20/1968 5/20/1968 5/24/1968 5/29/1968 6/3/1968 N 4/17/1968 NOT AN ASSIGNED NUMBER GANES CHEMICALS, INC., PENNSVILLE DIVISION BROWN CO PHYTOGEN PRODS INC PHYTOGEN PRODS INC PHYTOGEN PRODS INC TROPONWERKE GMBH CO KG RHODIA INC RHODIA INC CP HALL CO KRATON POLYMERS US LLC STEPAN COMPANY KAY-FRIES CHEMS FISONS LTD FISONS LTD EI DUPONT DE NEMOURS AND CO EXXONMOBIL CHEMICAL CO TRAVENOL LABORATORIES INC UNION CARBIDE CORPORATION UNION CARBIDE CORPORATION LYNE LABORATORIES INC AMERICAN CYANAMID CO DISTILLATION PROD INDS DIV EASTMAN KODAK CO EISAI CO LTD BF GOODRICH CHEM CO JRS PHARMA LP MFG. PACKAGING AND ANALYSIS OF SODIUM PHENOBARBITAL SOLKA FLOCS FACILITIES, PERSONNEL AND PROCESS IDENTIFICATION, ASSAY & SPECIFICATION FOR MESTRANOL IDENTIFICATION, ASSAY & SPECIFICATION FOR DIMETHISTERONE D714 MFG. ANALYTICAL SPECS. & METHODS OF ANALYSIS FOR MEL B (ARSOBAL) I I I C N I II 4/8/1968 4/19/1968 II 4/10/1968 4/1/1968 4/18/1968 4/9/1968 I I I 3/26/1968 4/8/1968 4/8/1968 STATUS Type SUBMIT DATE 3/29/1968 HOLDER WARNER LAMBERT CO PHARMACEUTICAL RESEARCH DIVISION NAPP CHEMICALS INC NYSCO LABS INC VICTOR M HERMELIN CO DIV K-V PHARMACAL CO RHODIA INC RHODIA INC GANES CHEMICALS INC SIEGFRIED USA LLC NOT AN ASSIGNED NUMBER VIVONEX AND CO SIEGFRIED USA LLC VIVONEX-100 SUBJECT METHODS, FACILITIES AND CONTROLS MANUFACTURING PROCEDURES AND CONTROLS SODIUM FLUORIDE TIMED RELEASE CAPSULES MFG, PROCESS & PACK. OF DIMEHYDRINATE S.R.C. DICHLOROPHEN (ANTHIPEN) S.D. IMITATION CREME DE MENTHE FLAVOR RF 1487 (CODE 1201487) MANUFACTURE OF SODIUM BARBITAL ALLYLISOBUTYLBARBITURIC ACID & SODIUM ALLYLISOBUTYLBARBITURATE

4Q2012

PENTOBARBITOL AND SODIUM PENTOBARBITOL, USP, MANUFACTURED IN PENNSVILLE, NJ

POT. MELARSONYL-MEL W (TRIMELARSAN)-MFG, SPECS, & METH. OF ANALYSIS METH. FACILS. & CONTROL-IN MFG TETRAMETHYL SUCCINAMIDE (TMS) & ANALOGS STYRENE-BUTADIENE BLOCK COPOLYMERS NEOBEE M 20 ADENINE MANUFACTURE OF DEXTRAN 40 POWDER MANUFACTURE OF DEXTRAN 70 POWDER PRODUCTION PROCEDURE FOR GA-68 GENERATORS PLASKON-HIGH DENSITY POLYETHYLENE RESINS--PAXON MANUFACTURE, CONTROLS & PACKAGING OF ELLIOTT'S SOLUTION BAKELITE BRAND POLYETHYLENE RESIN DMD-5130 NATURAL 7 BAKELITE BRAND POLYETHYLENE RESIN DMD-5140 NATURAL 7 LITHIUM CARBONATE TABLETS SALICYLAZOSULFAPYRIDINE RETINOIC ACID (EASTMAN 8098) XYLITOL FOR INJECTION GEON 85542 (POLYVINYL CHL RESIN) SUGAR PRODUCT TO BE USED AS A NON-ACTIVE INGREDIENT BY TABLET DRUG

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4Q2012EXCEL DMF# 1196 1197 1198 1199 1200 I 1201 I 1202 1203 1204 1205 1206 1207 1208 1209 1210 1211 1212 1213 1214 1215 1216 1217 I 1218 I 1219 1220 1221 1222 1223 1224 I 1225 1226 1227 1228 1229 I 1230 1231 I I III II 9/4/1968 9/9/1968 UNION CARBIDE CORPORATION SYNTEX LABORATORIES INC SUB SYNTEX CORP I I I I IV I II 8/20/1968 8/21/1968 9/3/1968 8/16/1968 9/4/1968 I I I I I IV II III 8/15/1968 8/15/1968 8/14/1968 8/13/1968 8/14/1968 8/19/1968 I 8/6/1968 N I I I I I I I I I N I I I I III II II 7/26/1968 8/1/1968 6/21/1968 7/22/1968 8/2/1968 II III 7/12/1968 7/15/1968 7/16/1968 7/31/1968 7/19/1968 7/18/1968 7/19/1968 7/22/1968 7/25/1968 7/15/1956 STATUS Type SUBMIT DATE I I I I IV II III 6/18/1968 6/19/1968 6/20/1968 6/24/1968 7/5/1968 HOLDER UNION CARBIDE CORPORATION UNION CARBIDE CORPORATION RHODIA INC HENKEL KGAA SUBJECT BAKELITE' BRAND VINYL SHEET VGA-0403 NATURAL 7 AND CLEAR 1007 BAKELITE' BRAND DMDB-4300 NATURAL 7 POLYETHYLENE RESIN RHODIA FLAVOR RF-1698 (IMITATION PINEAPPLE FLAVOR) DEHYDOPLAST

4Q2012

VICTOR M HERMELIN AND CO DIV KV PENTRITOL (PENTAERYTHRITOL TETRANITRATE) TEMPULES 60MG CONT RLSE CAPSL PHARMACAL CO CIBA PHARMACEUTICAL CO DIV CIBA GEIGY SYNACTHEN (BA-30920) CORP NOT AN ASSIGNED NUMBER HENKEL KGAA CONTINENTAL CAN COMPANY KOLMAR LABORATORIES INC TROPONWERKE GMBH CO KG DOW CHEMICAL CO MICHIGAN DIV SYNTEX CORP PFISTER CHEMICAL COMPANY INC EDLAW PACKAGING CO INC ETHYL CORP NOT AN ASSIGNED NUMBER MONSANTO COMPANY TROPONWERKE GMBH CO KG C ALBERT SAUTER CO FLEXEL INC VICTOR M HERMELIN CO DIV K-V PHARMACAL CO ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV SYNTEX CORP SYNTEX CORP UNION CARBIDE CORPORATION TASTEMAKER KNOLL AG CHEMISCHE FABRIKEN VICTOR M HERMELIN CO DIV K-V PHARMACAL CO ANABOLIC INC PCR INC CILAG CHEMIE AG QUALICAPS PHARMAPHIL DIVISION D P T LABS INC ENZYME AP, A PROTEOLYTIC ENZYME DERIVED FROM B. SUBTILLIS PHENTERMINE (C.A. NAME,-DIMETHYLPHENETHYLAMINE) MANUFACTURING FACILS. (PHILADELPHIA PLANT) AVISCO CELLOPHANES PENTRITOL-B (PETN 30MG & BUTABARBITAL 50MG TEMPULES) MANUFACTURING SITE,FACILITES,PERSONNEL, AND GENERAL MANUFACTURING PROCEDURES. 6A-FLUORO-11B,17A,21-TRIHYDROXY-16A-METHYLPREGN-4-ENE-3,20-DIONE(RS166 6A,9A,DIFLUORO-11B,17A,21-TRIHYDROXY-16A-METHYLPREGN-4-ENE-3,20-DIONE BAKELITE BRAND DFD-3201 ORANGE FLAV-O-LOK (MM 3X 610047) (DFORMERLY HELD BY POLAK'S FRUTAL) ETHAVERINE HYDROCHLORIDE (BARBONIN) DUOTRATE 30 PLATEAU CAPSULES PLACENTAL LYSATE - LYOPHILIZED 5-FLUOROURACIL MANUF FACILS AND CONTROLS FOR ISOPROTERENOL HYDROCHLORIDE HARD SHELL GELATIN CAPSULES MANUFACTURED IN WINDSOR, CANADA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. POLYETHYLENE RESINS (BAKELITE SERIES) 6A-FLURO-9A,11BDICHLORO-16A,17A,21-TRIHYDROXYPREGNA-1,4-DIENE-3, 20-DI EDENOL 133 SEPRO POROSITONES R CLOFOREX AS MFG. IN KOLN MULHEIM, GERMANY SARAN FORMULATIONS 1-(3'B-HYDROXYCHOLEST -5' -EN-7'E-YL)-1,5-DIAZABICYELO-(4,3,0)-NONECHL TRIBROMOSALICYLANILIDE (TBS-100) UNIT PACKAGING ETHYL 9013 CL 09 POLYVINYL CHLORIDE COMPOUND

Page 34

4Q2012EXCEL DMF# 1232 1233 1234 I 1235 1236 1237 1238 1239 1240 1241 1242 1243 1244 1245 1246 1247 1248 1249 1250 1251 1252 1253 1254 1255 1256 I 1257 1258 1259 1260 1261 1262 1263 1264 1265 1266 1267 1268 1269 1270 I I I I I I I I I I I I I I II II II II II I I 10/30/1968 12/3/1968 12/3/1968 12/6/1968 12/13/1968 12/16/1968 12/16/1968 12/16/1968 12/16/1968 12/16/1968 12/16/1968 12/16/1968 12/19/1968 5/13/1968 I I I I A I A A I I I I I I I I I I I I I I II II II II II II II III IV II IV II 9/13/1968 9/16/1968 9/16/1968 9/19/1968 9/17/1968 9/19/1968 9/30/1968 10/2/1968 9/19/1968 10/18/1968 10/17/1968 10/23/1968 10/21/1968 10/23/1968 10/25/1968 10/23/1968 10/25/1968 10/23/1968 10/25/1968 11/6/1968 11/25/1968 12/5/1968 STATUS Type SUBMIT DATE I I IV II 9/10/1968 9/11/1968 9/11/1968 HOLDER UNION CARBIDE CORPORATION ABITEC CORPORATION SYNTEX LABORATORIES INC SUB SYNTEX CORP NUTRITIONAL BIOCHEMS CORP EGYPTIAN LACQUER MANUFACTURING CO GANES CHEMICALS INC PHYTOGEN PRODS INC AMERICAS STYRENICS LLC GULF OIL CORP FMC LITHIUM SUB FMC CORP EVONIK ROHM GMBH CAMDEN CHEM CO LTD ER SQUIBB AND SONS INC HAGER PACKAGING CORP ROUSSEL CORPORATION KEMKO INC TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD DIAMOND CHEM CO HUNTINGDON RES CTR MERRELL DOW RESEARCH INSTITUTE DIV MERRELL DOW PHARMACEUTICAL INC ANABOLIC INC ALUMINUM COMPANY OF AMERICA BECTON DICKINSON AND CO NAPP CHEMICALS INC DOW CORNING CORP GENERAL ELECTRIC CO GENERAL ELECTRIC CO GENERAL ELECTRIC CO GENERAL ELECTRIC CO GENERAL ELECTRIC CO GENERAL ELECTRIC CO GENERAL ELECTRIC CO BECTON DICKINSON AND CO BECTON DICKINSON AND CO SUBJECT BAKELITE BRAND DYNH RESIN HARD BUTTER PRODUCTS D-2-(6-METHOXY-2-NAPHYTHYL) PROPIXONIC ACID L-DOPA CV-1443 HEAT SEAL COATING DIPHENHYDRAMINE HYDROCHLORIDE ANAGESTONE ACETATE BAKELITEBRAND RUBBER MODIFIED POLYSTYRENE TMD(F) A-9501 NATURAL BAKELITE BRAND POLYSTRENE SMD(F) 3500 NATURAL LITHIUM CARBONATE, MFG PROCEDURES EUDRAGITS CAMCOLIT DESFLUORO TRIAMCINOLONE ACETONIDE PHYSICAL FACILITIES & OPERATIONS METHYLOXINE BROMOMETHYLOXINE METHYLOXINE N-DODECYLSULFATE MEPROBAMATE N.F.XII L-THREONINE L-METHIONINE L-ISOLEUCINE L-HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE L-TRYPTOPHAN L-VALINE CUSTOM PACKAGING OPERATION HUNTINGDON RESEARCH CENTRE BROCHURE

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES . MANUF, CONTROL & HOUSEKEEPING STANDARD OPER. PROCEDS, EQUIPMENT PERSON PILFERPROOF CLOSURE (38MM) FOR STERILE SOLUTIONS TRITIATED CYTIDINE MANUFACTURE AND CONTROL OPERATIONS DOW CORNING 556 FLUID CALCIUM 45, PRODUCT SPECIFICATIONS AND PROCESS DESCRIPTIONS CALCIUM-47 CHROMIUM-51 SELENIUM-75 RUBIDIUM-86 YTTERBIUM-169 MERCURY-203 ADENOSINE CYCLIC PHOSPHATE MANUF. BY SCHWARZ BIORESEARCH DIBUTYRYL CYCLIC MONOPHOSPHATE SODIUM MANUF. BY SCHWARZ BIORESEARCH

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4Q2012EXCEL DMF# 1271 1272 1273 1274 1275 1276 1277 1278 1279 1280 1281 1282 1283 1284 1285 1286 1287 1288 1289 1290 1291 1292 1293 1294 1295 1296 1297 1298 1299 1300 1301 1302 1303 1304 1305 1306 1307 1308 1309 1310 1311 STATUS Type SUBMIT DATE A I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I III III III III III III III III III III III III III III III III III III III III III III III III III III III III II II II II II II 12/13/1968 12/27/1968 12/27/1968 12/31/1968 12/31/1968 12/26/1968 12/26/1968 12/26/1968 12/26/1968 11/12/1968 12/2/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 11/27/1968 12/31/1968 1/6/1969 1/6/1969 1/13/1969 1/13/1969 1/13/1969 1/17/1969 1/13/1969 HOLDER CHATTEM CHEMICALS INC TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD GENERAL ELECTRIC CO GENERAL ELECTRIC CO GENERAL ELECTRIC CO GENERAL ELECTRIC CO MILPRINT INC VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP VALSPAR CORP WALLERSTEIN FLINT HILLS RESOURCES LP VALSPAR CORP VALSPAR CORP VALSPAR CORP TENNESSEE EASTMAN CO-ORIG GEIGY PHARMS SUBJECT AMINOACETIC ACID (GLYCINE) AS PREPARED BY CHATTEM CHEMICALS L-ASPARTIC ACID L-PHENYLALANINE L-ARGININE MONOHYDROCHLORIDE L-LEUCINE IRON-59 STRONTIUM-85 TIN-113 TIN-119M PHARMACEUTICAL PACKAGING MATERIAL, NEALAM (R) 40455

4Q2012

37 MOBIL PACKAG. COATINGS FORMULATIONS:S-1299-001;005;010;013;024;&030 37 MOBIL PACKAGING COATINGS FORMULATIONS S-9658-501 37 MOBIL PACKAGING COATINGS FORMULATIONS S-9094-001, S-9094-002 37 MOBIL PACKAGING COATINGS FORMULATIONS S-9092-001 37 MOBIL PACKAGING COATINGS FORMULATIONS S-9087-001 37 MOBIL PAKAGING COATINGS FORMULATIONS S-9075-001,S-9075-002,003,004 37 MOBIL PACKAGING COATINGS FORMULATIONS S-8998-001 37 MOBIL PACKAGING COATINGS FORMULATIONS S-8998-004 37 MOBIL PACKAGING COATINGS FORMULATIONS S-8988-003 37 MOBIL PACKAGING COATINGS FORMULATIONS S-8988-002 37 MOBIL PACKAGING COATINGS FORMULATIONS S-8958-002 37 MOBIL PACKAGING COATINGS FORMULATIONS S-8958-001 37 MOBIL PACKAGING COATINGS FORMULATIONS S-8586-002 37 MOBIL PACKAGING COATINGS FORMULATIONS S-8480-001, S-8480-002 37 MOBIL PACKAGING COATINGS FORMULATIONS S-8327-001 37 MOBIL PACKAGING COATINGS FORMULATIONS S-8279-001 37 MOBIL PACKAGING COATINGS FORMULATIONS S-3208-004 37 MOBIL PACKAGING FORMULATIONS S-1961-106, S-1961-107 37 MOBIL PACKAGING COATINGS FORMULATIONS S-1961-101 37 MOBIL PACKAGING COATINGS FORMULAS S-1300-001,S1300-004, S-1300-009 37 MOBIL PACKAGING COATINGS FORMULATIONS S-1299-018, S-1299-029 37 MOBIL PACKAGING COATINGS FORMULATIONS S-1299-026 37 MOBIL PACKAGING COATINGS FORMULATIONS S-1298-001 MOBIL PACKAGING FORMULATION S-1167-025 MICROBIAL LIPASE POLYETHYLENE PE 107 MANUFACTURED IN ODESSA, TEXAS. PACKAGING FORMULATION S-6265-011 PACKAGING FORMULATION S-1518-016 PACKAGING FORMULATION S-1518-018 PRODUCT ISOBUTYL 2-CYANOACRYLATE, MED GRADE & VISCOUS ISOBUTYL CALCIUM CHEL 330

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4Q2012EXCEL DMF# 1312 1313 1314 1315 1316 1317 1318 1319 1320 1321 I 1322 I 1323 1324 1325 1326 1327 1328 1329 1330 1331 1332 1333 1334 1335 1336 A 1337 1338 1339 1340 1341 1342 1343 1344 1345 1346 1347 I 1348 I 3/21/1969 I I I I I I I I I I III II II 2/20/1969 2/28/1969 2/28/1969 2/28/1969 2/26/1969 2/28/1969 3/14/1969 3/17/1969 3/14/1969 3/18/1969 3/24/1969 I I I I I I I I I I I I A III III III III 2/6/1969 2/7/1969 2/10/1969 2/17/1969 2/17/1969 2/17/1969 2/17/1969 2/17/1969 2/17/1969 2/17/1969 2/17/1969 2/13/1969 2/14/1969 2/24/1969 2/12/1969 STATUS Type SUBMIT DATE I I I I I I I I I II II II 1/22/1969 1/22/1969 1/23/1969 1/23/1969 1/23/1969 1/23/1969 1/23/1969 2/3/1969 2/10/1969 2/7/1969 HOLDER UOP FRAGRANCES US MILPRINT INC SYNAPSE INC TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD CURWOOD INC SOLVAY PHARMACEUTICALS VICTOR M HERMELIN CO DIV K-V PHARMACAL CO VICTOR M HERMELIN CO DIV K-V PHARMACAL CO PHYTOGEN PRODS INC COLONIAL SUGAR REFINING CO LTD EASTMAN CHEMICAL CO MILPRINT INC MILPRINT INC MILPRINT INC MILPRINT INC MILPRINT INC MILPRINT INC MILPRINT INC MILPRINT INC MILPRINT INC ROHM AND HAAS CO PIERCE & STEVENS CHEMICAL CORPORATION FOOD AND DRUG RES LABS INC GENERAL ELECTRIC CO GENERAL ELECTRIC CO GENERAL ELECTRIC CO GENERAL ELECTRIC CO GENERAL ELECTRIC CO ORGANON INC RSA CORPORATION CORMEDICS CORP MIDLAND DIVISION DEXTER CORPORATION PIERCE & STEVENS CHEMICAL CORPORATION VICTOR M HERMELIN CO DIV K-V PHARMACAL CO SUBJECT PERFUME BOUQUET #15741 (ANTOINE CHIRIS) MILSEAL 42601 L-DOPA DL-VALINE DL-PHENYLALANINE DL-TRYPTOPHAN DL-THREONINE CURWOOD'S 3802 PHARMACEUTICAL PACKAGING FILM LITHIUM CITRATE SYRUP DILAC 30MG SUSTAINED RELEASE CAPSULES DILAC 30MG /PHENOBARBITAL 45MG SUSTAINED RELEASE CAPSULES 19-NOR-17-ALPHA-ETHINYLTESTERONE CALCIUM SUCROSE PHOSPHATES (ANTICAY) PROPYLENE-ETHYLENE POLYALLOMERS(TENITE POLALLOMERS) MILSEAL 31100 SERIES MILSEAL 31600 SERIES MILSEAL 32000 SERIES MILSEAL 33200 SERIES MILSEAL 34050 SERIES NEALAM 43550 SERIES SUPEREL 55300 SERIES NEALAM 60550 SERIES NEALAM 60650 SERIES, PACKAGING MATERIALS ADHESIVE FORMULATIONS PROXSEAL E-9327 PACKAGING MATERIALS STRUCTURES CADMIUM-109 IRON-55 PHOSPHORUS-32 THALLIUM-204 THULIUM-170 DEXAMETHASONE 21-TERTIARY BUTYLACETATE DITHIOTHREITOL

4Q2012

KEY PERSONNEL, MANUF FACILS, CONTROL PROCEDURES AND QUALITY STANDARDS 321-177A CLEAR COATING (PERMANENT MIDLAND CODE V-1073) AND 321-177B PROXSEAL E- 9133 MANUF, FACILS, PERSONNEL, CONTROLS & SPECIFS FOR METRANIL 80MG SUS CPS

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4Q2012EXCEL DMF# 1349 I 1350 I 1351 I 1352 1353 1354 1355 1356 1357 I 1358 1359 1360 1361 1362 1363 1364 1365 1366 1367 1368 1369 1370 1371 1372 1373 I 1374 1375 1376 1377 1378 I I I I III 6/9/1969 6/10/1969 6/11/1969 6/10/1969 6/23/1969 UNION CARBIDE CORPORATION MIDCO PRODS CO CALBIOCHEM CORP MILPRINT INC TEKNI PLEX INC I I I I A A I I I I I I I I A III I III II III II III III III 4/28/1969 4/11/1969 4/30/1969 4/28/1969 4/24/1969 5/2/1969 5/9/1969 5/12/1969 5/5/1969 5/7/1969 5/13/1969 5/21/1969 5/28/1969 5/26/1969 5/20/1969 6/4/1969 I I I I A II II II 4/14/1969 4/18/1969 6/8/1969 4/21/1969 3/18/1969 4/28/1969 PHARMATON LTD FOOD AND DRUG RES LABS INC EL PASO POLYOLEFINS CO EI DUPONT DE NEMOURS AND CO DOW CHEMICAL CO SYNTEX LABORATORIES INC SUB SYNTEX CORP EASTMAN CHEM PRODS INC MAUMEE CHEM CO REICHHOLD CHEMICALS INC RT VANDERBILT CO INEOS OLEFINS AND POLYMERS USA CHEVRON PHILLIPS CHEMICAL CO LP P-L BIOCHEMS INC P-L BIOCHEMS INC PARAMOUNT PACKAGING CORP LILLY RES LABS DIV ELI LILLY CO VALSPAR CORP SOLVAY PHARMACEUTICALS MICROBIOLOGICAL ASSOC P-L BIOCHEMS INC EI DUPONT DE NEMOURS INC PROCTER AND GAMBLE CO I 4/8/1969 ALLERGAN PHARMACEUTICAL II 4/24/1969 STATUS Type SUBMIT DATE I 3/28/1969 HOLDER SYNTEX LABORATORIES INC SUB SYNTEX CORP DINAMITE DIPHARMA SPA SUBJECT A DESCRIPTION OF OUR CLARK, NEW JERSEY WAREHOUSE

4Q2012

PROPOXYPHENE HYDROCHLORIDE MANUFACTURED IN THE BARANZAE DI BOLLATE (MILAN), ITALY FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF OPTHALMIC PREPS IN IRVINE, CALIFORNIA. NEO-LIDOCATION IDENTITY & STRUCTURE OF A COMB. CLOSURE & DOSAGE MEAS SPOON MANUF ALCO POLYPROPYLENE RESIN COMPOUNDS USED IN MANUF. PLASTIC CONTAINERS RUBIDIUM-84 CARBOWAX POLYETHYLENE GLYCOL GUANADREL (CL-1388-R) TENITE POLYETHYLENE 860E-69141 WHITE TRIBROMOSALICYLANILIDE BLACK TUBING VANCIDE TBS. FORTIFLEX (R) POLYETHYLENE RESIN POLY-ETH POLYETHELYNE 5555 RESIN POLYCYTIDYLIC ACID (POLY C) POLYINOSINIC ACID (POLYI) FLEXIBLE PACKAGING MATERIALS LEVODOPA (COMPOUND 7550) FORMULATION S-3414-102 SODIUM FLUORIDE TABLETS AND CAPSULES POLYRIBOINOSINIC ACID AND POLYRIBOCYTIDYLIC ACID DITHIOTHREITOL SURLYN IONOMER RESINS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GREENVILLE, SOUTH CAROLINA. VINYLITE BRAND COATED PAPER VDI 6645 WHITE 1435 PACKAGING L-DOPA TABLETS MILSEAL 33250 SERIES PACKAGING FILMS-LAMINATED, CLOSURE LINER MATERIALS, AND LIDDING MATERIALS MANUFACTURED AT FLEMINGTON NJ AND SOMERVILLE NJ.

A 1379 1380 I I 6/19/1969 6/26/1969 GEORGE UHE CO GENERAL SILICONES PTY LTD METHAQUALONE BASE GENSIL 39 ANTI-FOAM COMPOUND

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4Q2012EXCEL DMF# 1381 I 1382 1383 1384 1385 1386 I 1387 1388 1389 1390 1391 1392 1393 1394 1395 1396 1397 1398 I 1399 1400 1401 I 1402 I 1403 1404 1405 1406 1407 1408 1409 1410 1411 1412 1413 A 1414 1415 1416 I I I III III 8/27/1969 8/29/1969 8/29/1969 THE DOW CHEMICAL COMPANY ALUMINUM COMPANY OF AMERICA BF SCHOEN I N I I I I I I I A II II II II III 7/29/1969 8/13/1969 8/12/1969 8/20/1969 8/18/1969 8/15/1969 8/21/1969 9/2/1969 9/2/1969 8/5/1969 II 8/1/1969 I I II 7/31/1969 8/1/1969 8/1/1969 I I I I I A I I I I I II III III II 6/10/1969 7/14/1969 7/1/1969 7/15/1969 7/16/1969 7/18/1969 7/24/1969 7/24/1969 7/30/1969 7/8/1969 7/25/1969 7/30/1969 I I I I II III 4/25/1969 6/26/1969 7/1/1969 7/11/1969 6/27/1969 STATUS Type SUBMIT DATE II 7/1/1969 HOLDER VICTOR M HERMELIN CO DIV K-V PHARMACAL CO REICHHOLD CHEMICALS INC PRINT PACK INC RHODIA INC DELTA RUBBER CO VICTOR M HERMELIN CO DIV K-V PHARMACAL CO REXHAM CORP ORGANON INC HOWMEDICA INC MONSANTO COMPANY ER SQUIBB AND SONS INC PECHINEY PLASTIC PACKAGING INC WORTHINGTON BIOCHEM CORP ROHM AND HAAS CO SPARKS CORP SPARKS CORP CALBIOCHEM-BEHRING CORP VICTOR M HERMELIN CO DIV K-V PHARMACAL CO M AND T CHEMS INC UNIV OF WISCONSIN KEY PHARMACEUTICALS INC SUB SCHERING PLOUGH CORP VICTOR M HERMELIN CO DIV K-V PHARMACAL CO DOW CORNING CORP NOT AN ASSIGNED NUMBER FARMITALIA SPA PHARMACIA AND UPJOHN INC ORGANON INC SILGAN PET CORP EDWARD MENDELL CO INC VISION PACKAGING CO GENERAL ELECTRIC CO PFIZER INC PHARMACIA AND UPJOHN FORMOCORTAL CORTISONE (MICRONIZED, ACETATE AND STERILE) ESTRIOL MONSANTO POLYETHYLENE M.P.E. 212: ALSO IN FOOD ADDITIVE FILE #118 CAPILLACT (DISINTERGRAING AGENT) PERSONNEL AND FACILITIES NICKEL-63 PREDNISONE,MICRONIZED,STERILIZED AND ACETATE SUBJECT DARVON (PROPOXYPHENE HCL) SUSTAINED RELEASE CAPSULES RUBBER TUBING LAMINATIONS AND LAMINAING PROCEDURES. RP 4763, (SPECIA) BEMARSAL FORMULAS #B-501, #B-502 RED BUTYL AND #R-503, #R-505 BLUE RUBBER DILAC 80MG (PENTAERYTHRITOL TETRANITRATE RIMED DISINT CAPSULES LAMINAING ADHESIVE, RIEGEL CODE NO. A-1708 ALPHA-ESTRADIOL SURGICAL SIMPLEX P AND SURGICAL SIMPLEX RADIOPAQUE MONSANTO POLYETHYLENE MPE 80

4Q2012

D-GLUCOSAMINE HYDROCHLORIDE SOLUTION, 2N SODIUM HYDROXIDE SOLUTION MANUFACTURING PROCEDURES & FACILITIES, PACKAGING DEXTRANASE HYDROXYETHYL METHACRYLATE 94% MANUFACTURING PROCEDURE, EQUIPMENT AND CONTROL PLANT #2 MANUF PROCEDURE, EQUIPMENT AND CONTROLS OF PLANT #1 CYTOSINE ARABINOSIDE AND CYSTOSINE ARABINOSINE HYDROCHLORIDE NEO-COROVAS TYM CAPS 30MG (PENTAERYTHRITOL TETRANITRATE M AND T SPECIAL WHITE TIN OXIDE-POLISHING GRADE 25-HYDROXY-CHOLECALCIFEROL L-DOPA COROVAS TYMCAPS(PENTAERYTHRITOL TETRA NITRATE) DOW CORNING 386 FOAM ELASTOMER

HYDROCORTISONE MICRONIZED AND NON-MICRONIZED AS MANUFACTURED IN KALAMAZOO, MICHIGAN BAKELITE BRAND POLYETHYLENE RESIN DNDA-01800 NATURAL 7 ALCOA NUMBERS 9003, 9004, 9005 (PHAR 9003, 9004, 9005) PREGNANEDIOL

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4Q2012EXCEL DMF# 1417 I 1418 1419 I 1420 I 1421 I 1422 1423 1424 1425 A 1426 1427 1428 1429 I 1430 1431 1432 1433 1434 1435 1436 1437 1438 1439 I 1440 I 1441 1442 1443 1444 1445 1446 I 1447 I 1448 I I 9/23/1969 I 12/3/1969 N I I I I II 10/28/1969 10/31/1969 11/7/1969 11/21/1969 11/26/1969 NOT AN ASSIGNED NUMBER ISO-MED INC ORGANON INC CERTIFIED LABS INC KNOLL AG CHEMISCHE FABRIKEN VICTOR M HERMELIN CO DIV K-V PHARMACAL CO MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC SODIUM RADIOFLUORIDE HUMAN CHORIONIC GONADOTROPIN MANUFACTURING STANDARD OPERATING PROCEDURES VERARYL CYANIDE AND HOMOVERARYLAMINE DUOTRATE 45MG PLATEAU CAPSULES MANUF.CONTROL,FACILITIES &PROCEDURES-A RAHWAY, NJ PLANT MANUF, CONTROL FACILITIES PROCEDURES FOR ALBANY, GA. PLANT I 10/29/1969 PHARMACIA LABS INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PISCATAWAY, NEW JERSEY. I I A I I I I I I II I II II II III 6/10/1969 9/16/1969 9/18/1969 9/4/1969 10/6/1969 10/7/1969 10/8/1969 10/8/1969 10/20/1969 10/24/1969 I I I II II II 9/7/1969 9/11/1969 8/20/1969 3/3/1969 FORNOVO FARMACHIMICI SRL ZENITH LABORATORIES INC TERRA MARINE BIORESEARCH VICTOR M HERMELIN CO DIV K-V PHARMACAL CO ALUMINUM COMPANY OF AMERICA ORGANON INC PHARMACIA AND UPJOHN SUB PFIZER INC MILPRINT INC ER SQUIBB AND SONS INC SCHERING AG OLIN CHEMICAL GROUP OLIN CHEMICAL GROUP HERCULES INC UNITED STATES DEPARTMENT ENERGY I I A III III 9/4/1969 9/8/1969 9/8/1969 9/4/1969 8/29/1969 9/5/1969 A II 9/4/1969 9/2/1969 STATUS Type SUBMIT DATE 9/3/1969 HOLDER VICTOR M HERMELIN CO DIV K-V PHARMACAL CO PHARMACIA AND UPJOHN VICTOR M HERMELIN CO DIV K-V PHARMACAL CO VICTOR M HERMELIN CO DIV K-V PHARMACAL CO VICTOR M HERMELIN CO DIV K-V PHARMACAL CO ARMOUR PHARMACEUTICAL CO SCHWARTZ BIORESEARCH INC HENKEL CORP SABIC INNOVATIVE PLASTICS SUBJECT

4Q2012

DUROTATE PB (PETN 30MG AND PHENOBARBITAL 45MG) SUSTAINED RELEASE CAPS PROGESTERONE MICRONIZED AND CRYSTALS ANTORA B TIMED DISINTEGRATING CAPS PENTRAYTE TIMED CAPSULES (PETN 30MG) ANTORA (PETN) TIMED DISINTEGRATING CAPS SALMON CALCITONIN RIBONUCLEIC ACID RNA, YEAST NUCLEIC ACID GELVA? MULTIPOLYMER RESIN SOLUTIONS (GMS) NORYL* RESINS AS MANUFACTURED IN SELKIRK, NEW YORK (USA), AND BERGEN-OPZOOM, THE NETHERLANDS. IMINODIBENZYL TOLAZAMIDE POWDER CYTOSINE ARABINOSIDE ISORDIL TEMBIDS (ISOSORBIDE DINITRATE) SRC POLYMERIC HEA-SEAL COATED ALUMINUM FOIL 9403, 9404, AND 9405 ETHINYL ESTRADIOL PREDNISOLONE USP MANUFACTURED IN KALAMAZOO, MICHIGAN. FLEXIBLE PACKAGING MATERIALS PROLIXIN ELIXIR (FLUPHENAZINE HYDROCHLORIDE) GENERAL OPERATING PROCEDURES FOR BULK PRODUCTS PYRIDINETHIONE DISULFIDE (OMADINE DISULFIDE) 2,2' PYRIDYLDISULFIDE (2,2' PYRIDINE DISULFIDE) POLYMER S2062 RADIOISOTOPE MOLYBDENUM-99-P-2 UNPROCESSED(FORMERLY UNION CARBIDE CORP

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4Q2012EXCEL DMF# 1449 I 1450 I 1451 I 1452 I 1453 1454 1455 1456 1457 1458 I 1459 1460 1461 1462 1463 I 1464 1465 I 1466 1467 1468 1469 1470 I 1471 I 1472 I 1473 1474 1475 1476 1477 1478 1479 I 1480 1481 I N III 2/6/1970 I I I I I A III II III I 1/21/1970 1/29/1970 1/26/1970 1/23/1970 12/29/1969 2/3/1970 2/6/1970 1/14/1970 I 12/16/1969 A A I N I 11/21/1969 III II III 1/8/1970 12/31/1969 1/15/1970 AMCOR RIGID PLASTICS USA INC DOW CORNING CORP POLYTHERM KASSEL NOT AN ASSIGNED NUMBER DUPONT PHARMACEUTICALS DIV EI DUPONT DE NEMOURS & CO SERVICE MAILING & PRINTING COMPANY INC DEWEY AND ALMY CHEM DIV WR GRACE AND CO SYNTEX USA INC ALUMINUM COMPANY OF AMERICA GOODYEAR TIRE AND RUBBER CO BEECHAM PHARMS DIV BEECHAM PRODS MODERN PACKAGING INC CAMBREX PROFARMACO MILANO SRL USV PHARMACEUTICAL CORP SUB RORER GROUP KERR GLASS MANUFACTURING CORP NOT AN ASSIGNED NUMBER MFG. FACILS. (FORMERLY ENDO LABS INC.) PERSONNEL, FACILITIES, METHODS & CONTROLS DEWEY AND ALMAY AEROSOL COMPOUNDS S1419 AND S1420 GENERAL DESCRIPTION OF RENO, NEVADA WAREHOUSE PLASTIC BOTTLES MANUFACTURED IN MAYS LANDING, NEW JERSEY. DOW CORNING R SIMETHICONE COMPOUNDS AND EMULSION POLYVINYL CHLORIDE FILM A III I 12/17/1969 3/25/1970 I I I I II 12/18/1969 12/18/1969 12/15/1969 12/30/1969 12/22/1969 I I I I N II 12/15/1969 II 12/5/1969 12/12/1969 12/5/1969 12/4/1969 8/18/1969 9/23/1969 I 9/23/1969 STATUS Type SUBMIT DATE I 9/23/1969 HOLDER MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC RECHERCHES ET INFORMATIONS BIOLOGIQUES ESSEX SAIC SUB SCHERING CORP UPJOHN CO SHERAMEX SA DE CV VITARINE CO INC NOT AN ASSIGNED NUMBER ABBOTT LABORATORIES PHARMACEUTICAL ERYTHROMYCIN B PRODUCTS DIV BIO DERIVATIVES CORP L-DOPA P ROBERTET INC ORGAMOL SA CHATTEM DRUG & CHEMICAL COMPANY VICTOR M HERMELIN CO DIV K-V PHARMACAL CO AMERICAS STYRENICS LLC DERMODOR LAVENDER FOUGERE 3066 BIS METHAQUALONE HYDROCHLORIDE POWDER SUBJECT MANUF. CONTROL FACILITIES & PROCEDURES FOR DANVILLE PA PLANT MANUF. & CONTROL,FACILITIES & PROCEDURES-FOR ELKTON, VA. PLANT MANUFACTURING, CONTROLS, FACILITIES & PROCEDURES

4Q2012

MEETHODS, FACILITIES AND CONTROLS, USED IN PACKING DRUG SUBSTANCES METHODS, FACILS, AND CONTROLS USED IN MANUF. CHEMICAL SUBSTANCES FLUPREDNISOLONE & FLUPREDNISOLONE ACETATE METHODS, FACILITIES, CONTROLS, PROCESSING AND PACKAGING GENERAL OPERATING PROCEDURE FOR PARENTERAL PREPARATIONS

ALUMINUM HYDROXIDE LOW TEMPERAURE GLYCINE 2:1 DRIED GEL AHLTG-21 DUOTRATE PB 45MG PLATEAU CAPSULES BAKELITE BRAND OF POLYSTYRENE (RESIN SMD-3700 NATURAL.

EON LABS MFG OF THE VIRGIN ISLANDS INC MANUFACTURING INFO ON CARIBE CHEMICAL CO., INC.

PHAR ALWARP 9802, 9803, 9804, FOIL CONTAINER AND ALWARP 9606 CLOSURE POLYESTER RESINS TRAUMAIC ACID PACKAGING FORMULATIONS. DIAZEPAM METHOD, FACILITIES, CONTROLS, PROCESSING AND PACKING OF DRUGS PERMA CLEAR 2000 RESIN COMPOUND

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4Q2012EXCEL DMF# 1482 1483 1484 1485 1486 1487 1488 1489 1490 1491 1492 I 1493 1494 1495 I 1496 1497 I 1498 I 1499 1500 1501 1502 1503 1504 1505 I 1506 1507 I 1508 1509 1510 1511 1512 1513 I 1514 1515 1516 I I A II II 3/13/1970 4/23/1970 4/23/1970 SOLAR CHEMICAL CORP MALLINCKRODT INC SANOFI AVENTIS CHIMIE POLYSTYRENE RESINS METHADONE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE I I I I I III II 3/25/1970 3/11/1970 3/25/1970 4/7/1970 4/8/1970 4/16/1970 LILLY RES LABS DIV ELI LILLY CO ZENITH LABORATORIES INC SEMBL INC UNION CARBIDE CORPORATION UNION CARBIDE CORP HERCULES INC I I 3/19/1970 3/27/1970 MANBRITT INDUSTRY INC GLAXO WELLCOME INC INJECTION BLOW MOLDING OF PLASTIC CONTAINERS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GREENVILLE, NORTH CAROLINA. 1-METHADONE HYDROCHLORIDE PENICILLIN PLANT OPERATION IN ENGLEWOOD, NEW JERSEY PACKAGING, FACILITIES, CONTROLS POLYMER JR & LR RESINS SHELL POLYPROPYLENES A A I I I I III IV III 3/6/1970 3/12/1970 3/18/1970 3/16/1970 3/16/1970 2/11/1970 3/21/1970 3/9/1970 N 3/19/1970 NOT AN ASSIGNED NUMBER WINTHROP PHARMACEUTICALS DIV STERLING DRUG INC WINTHROP PHARMACEUTICALS DIV STERLING DRUG INC DOW CORNING CORP DUPONT PERFORMANCE POLYMERS CMW LABS LTD AMERICAN CYANAMID CO GENERAL ELECTRIC CORP EASTMAN CHEMICAL CO FACILITIES, METHODS AND CONTROLS MANUFACTURING DETAILS FOR SPECIFIC CHEMICALS DOW CORNING 360 MEDICAL GRADE FLUID DUPONT NYLON RESIN C.M.W. BONE CEMENT POWDER AND LIQUID DESCRIPTION OF DAVIS AND GECK PLANT FACILS AND PERSONNEL COMPOSITION OF LEXAN (R) 144-803) TENITE POLYPROPYLENE PRODUCTS I I I IV 1/12/1970 3/9/1970 2/27/1970 STATUS Type SUBMIT DATE I I I I N N I I I N 3/6/1970 2/13/1970 2/16/1970 2/18/1970 I II II 2/6/1970 2/11/1970 2/12/1970 2/6/1970 HOLDER ORGANICHEM CORP GALLARD-SCHLESINGER CHEM MFG CORP DONELAIN PHARMACEUTICALS INC SCHERING AG NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER DOW CHEMICAL CO MICHIGAN DIV GENERIC PHARMS INC DOW CORNING CORP NOT AN ASSIGNED NUMBER ABBOTT LABORATORIES PHARMACEUTICAL CYCLAMATE, SACCHARIN AND CYCLOHEXYLAMINE PRODUCTS DIV STEPAN COMPANY DEFOAMER FD 101, FD 102,FD 104, L-500 AND DREWFLOC 225 AND 412 RICHLYN LABORATORIES INC ZENITH LABORATORIES INC PHARMACEUTICAL MANUF, FACILITIES, PERSONNEL AND QUALITY CONTROL PEI 600 POLYETHYLENIMINE PLANT FACILITIES, MANUFACTURING AND QUALITY CONTROL SILASTIC 9711 MEDICAL GRADE ELASTOMER SUBJECT STRONTIUM 87M GENERATOR IMINODIBENZYL

4Q2012

PLANT FACILITIES, PERSONNEL AND CONTROL PROCEDURES FOR DRUG ITEMS GEN. OPERATING PROCEDS FOR BULK PRODUCTS-SCHERING AG BERGKAMEN PLANT

MANUFACTURING FACILS, PERSONNEL AND CONTROL PROCEDS OF NORTHVALE PLANT

BENEFICIADORA E INDUSTRIALIZADORA SA METHODS, FACILITIES, AND CONTROLS

DIVINYL ETHER-MALEIC ANHYDRIDE COPOLYMER (ALSO CALLED PYRAN COPOLYMER)

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4Q2012EXCEL DMF# 1517 I 1518 A 1519 1520 1521 1522 1523 1524 I 1525 I 1526 1527 1528 A 1529 1530 1531 1532 1533 1534 1535 1536 1537 1538 1539 1540 1541 1542 1543 1544 1545 1546 1547 I 1548 I 1549 1550 1551 I I I II 7/23/1970 7/16/1970 6/3/1970 II 7/23/1970 A I I I A I I I I I A I I I I I I A III III II II III II I I III II II IV 5/20/1970 5/26/1970 6/4/1970 6/8/1970 6/4/1970 6/1/1970 6/11/1970 6/9/1970 6/9/1970 6/23/1970 6/17/1970 6/25/1970 6/25/1970 6/25/1970 7/7/1970 7/14/1970 8/19/1970 8/13/1970 8/26/1970 I I III II 5/27/1970 2/18/1970 5/13/1970 5/11/1970 I I I I I I I 4/27/1970 4/27/1970 II I 5/4/1970 4/28/1970 4/27/1970 III 4/20/1970 STATUS Type SUBMIT DATE II 4/23/1970 HOLDER STERLING-WINTHROP RES INST DIV STERLING DRUG INC TOTAL PETROCHEMICALS AND REFINING USA INC RICHLYN LABORATORIES INC BEECHAM PHARMS DIV BEECHAM PRODS WYETH INC WYETH INC WYETH INC WYETH INC SUBJECT AMINACRINE HYDROCHLORIDE

4Q2012

ETHYLENE PROPYLENE COPOLYMER RESIN & POLYPROPYLENE HOMOPOLYMER RESIN FACILITIES, PERSONNEL, AND CONTROLS ON ANTIBIOTIC DRUG PRODUCTION 6-AMINOPENICILLANIC ACID MANUF FACILITIES FOR VARIOUS PLANTS OF WYETH LABORATORIES, INC. MFGR FACILS FOR THE VARIOUS PLANTS OF WYETH LABS INC (CHICAGO PLANT)

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. ABBOTT LABORATORIES PHARMACEUTICAL MANUF, PACKAGING AND LABELING OF BULK CALCIUM AND SODIUM CYCLAMATE PRODUCTS DIV ELI LILLY AND CO MANUF AND CONTROL INFOR. FOR METHADONE HYDROCHLORIDE DISPERSIBLE TBLS SPARKS CORP EI DUPONT DE NEMOURS AND CO DUPONT PACKAGING & INDUSTRIAL POLYMERS STEPAN COMPANY CORD LABS INC ELKINS SINN INC SUB AH ROBINS CO CHASE CHEMICAL CO KERR GROUP SUB BERRY PLASTICS CORP PHARMACIA AND UPJOHN PHARMACIA AND UPJOHN SUB PFIZER INC NOVO NORDISK AS NOVO NORDISK AS PHILLIPS PETROLEUM CO PRETIUM PACKAGING KNOLL AG CHEMISCHE FABRIKEN PHARMACIA AND UPJOHN INC PHARMACIA AND UPJOHN INC ASSIA CHEMICAL LABORATORIES LTD HERCULES INC WEST PHARMACEUTICAL SERVICES INC WEST PHARMACEUTICAL SERVICES INC FASSON INDUSTRIAL DIVISION OF AVERY INTERNATIONAL AMSA ANONIMA MEDICINALI SINTETICI & AFFINI SPA REHEIS CHEM CO DIV ARMOUR AND CO ROUSSEL-UCLAF ROBECO CHEMICALS INC MANUF PROCEDURES, EQUIPMENT, PACKAGING AND CONTROLS DUPONT SPECIALTY POLYETHYLENE RESINS WECOBEE M MANUFACTURING AND QUALITY CONTROL PROCEDURES CONTRACT FILLING METHODS, FACILITIES AND CONTROLS PHYSICAL FACILITIES, MANUFACTURING METHODS, AND CONTROLS HIGH DENSITY POLYETHYLENE RESIN PACKAGINGS. CYTARABINE AS MANUFACTURED IN KALAMAZOO MI MEDRYSONE BOVINE PROTEOLYTIC ENZYME MIXTURE(BOVINE PEM) BVF 8001 70) CRYSTALLINE TRYPSIN NOVO FIBER FINISH FORMULATION S-2031 PHARMACEUTICAL BOTTLES BIPERIDEN AND BIPERIDEN HYDROCHLORIDE (AKINETON) FLUOROMETHOLONE MICRONIZED 16-METHYLDIOLONE ACETATE AND S.D. VII) 9(11)-ANHYDRO-16A METHYLPREDNIS MANUFACTURE OF NITROFURANTOIN HI-FAX SA 181A (A HIGH DENSITY POLYETHYLENE-POLYPROPYLENE ALLOY) RAW MATERIAL DESCRIPTIONS AND SPECIFICATIONS FOR RUBBER FORMULATIONS RUBBER FORMULATIONS COMPOSITION OF FASSON S-201 ADHESIVE PHENYLBUTAZONE ALUMINUM CHLORHYDROXIDE COMPLEX (S/6 BASIC ALUMINUM CHLORIDE) TRIAMCINOLONE ACETATE AND TRIAMCINOLONE (ALCOHOL) CETINATE

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4Q2012EXCEL DMF# 1552 I 1553 1554 1555 1556 1557 I 1558 1559 1560 1561 I 1562 A 1563 1564 I 1565 1566 1567 1568 1569 1570 1571 1572 1573 1574 1575 1576 1577 1578 1579 I 1580 I 1581 1582 1583 1584 1585 1586 I I I A N I 9/15/1970 III II I 9/21/1970 9/3/1970 9/8/1970 9/3/1970 II 10/1/1970 NORTHEASTERN PHARMACEUTICALS & CHEMICAL COMPANY INC AVENTIS PHARMA SA HERCULES INC ALPINE AROMATICS INC BRASKEM AMERICA INC NOT AN ASSIGNED NUMBER NATIONAL STARCH & CHEMICAL CORP ADHESIVE 14-9800 HEXACHLOROPHENE CROMOLYN SODIUM AND CROMOLYN SODIUM/LACTOSE BLEND HERCULON TYPE 123- POLYPROPYLENE STAPLE FIBER CORDIAL TYPE FLAVOR MOPLEN F---D NATURAL I I I I I I A A I I I I I A II III III III III III III 9/14/1970 9/25/1970 9/25/1970 8/3/1970 8/28/1970 8/28/1970 9/16/1970 9/21/1970 9/28/1970 9/29/1970 9/14/1970 10/9/1970 10/8/1970 9/3/1970 10/3/1970 I III I 9/8/1970 9/16/1970 III 8/26/1970 I I I I II 8/7/1970 8/17/1970 8/20/1970 8/25/1970 SYNTEX USA INC UNION CARBIDE CORPORATION ER SQUIBB AND SONS INC I I I I I 7/22/1970 7/29/1970 8/6/1970 8/11/1970 8/14/1970 STATUS Type SUBMIT DATE 7/23/1970 HOLDER MILLMASTER CHEM CO DIV MILLMASTER ONYX CORP PLASKON PRODUCTS INC UNION CARBIDE CORPORATION EI DUPONT DE NEMOURS AND CO BIO DERIVATIVES CORP FISONS PLC PHARMACEUTICAL DIV SUBJECT MEPROBAMATE UREA & MELAMINE FORMALDEHYDE MOLDING COMPOUNDS(PLASKON) BAKELITE BRAND VINYL RESIN QMDA-4361 CLEAR 847 METHYL METHACRYLATE NONOMER H-112

4Q2012

MFGR & CONTROL FOR L-DOPA MADE BY HAMARI PHARMACEUTICALS IN JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LOUGHBOROUGH, UNITED KINGDOM. FLURANDRELIDE ACETATE BAKELITE BRAND OF POLYETHYLENE RESIN DFDA-3210 NATURAL 7 TESTOLACTONE TABLETS, 250 MG

ABBOTT LABORATORIES PHARMACEUTICAL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PRODUCTS DIV PROCEDURES IN ROCKY MOUNT, NORTH CAROLINA. SABIC INNOVATIVE PLASTICS LEXAN * RESINS AS MANUFACTURED IN MT VERNON, INDIANA (USA), BURKVILLE, ALABAMA (USA), COBOURG, ONTARIO, CANADA, SINGAPORE, BERGEN-OP-ZOOM, THE NETHERLANDS, AND CARTAGENA, SPAIN FISONS CORP WINTHROP PHARMACEUTICALS DIV STERLING DRUG INC PHILLIPS PETROLEUM CO BROCKTON CONTRACT PACKAGING GRIFFIN LABS INC REYNAUD LTD BF GOODRICH COMPANY BF GOODRICH COMPANY ALBEA AMERICAS INC CHEVRON PHILLIPS CHEMICAL CO LP HOUSTON BIOCHEMICAL IND FINE ORGANICS INC PFANSTIEHL LABORATORIES INC REXHAM CORP EI DUPONT DE NEMOURS AND CO HONEYWELL ALLIED CHEM CORP SPINHALER, TORBO-INSUFFLATOR DEVICE MFGR, CONTROL PROCEDURES & FACILITIES-MYERSTOWN, PA., PLANT CLEAR POLYOLEFIN BOTTLES (CPO BOTTLES) GENERAL INFO ON PLANT, QUAL. CONTROL, EQUIP, PERSONNEL & MANAGEMENT GRIFFIN BIONITE CONTACT LENS IMITATION CITRUS FLAVOR #379LLA GEON 85658 GRADE BOTTLE COMPOUND GEON 85692 FOOD GRADE BOTTLE COMPOUND PLASTIC TUBES GULF POLY-ETH POLYETHYLENE RESINS FACILITIES FOR DRUG MANUFACTURING ZINC TEMASEPT IV (F.O. BRAND OF ZINC TRIBROMSALAN) D-XYLOSE RIEGEL RS HEAT SEAL COATING FORMULATION COBALT-57 ACLAR FLUOROCARBON RESIN & FILM; PLASKON & CAPRAN NYLON 6 RESIN & FILM PREPARATION-FLUOROMETHYL HEXAFLUOROISOPROPYL ETHER-STEP PROCEDS 1 & 2

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4Q2012EXCEL DMF# 1587 1588 I 1589 1590 1591 1592 1593 1594 1595 1596 I 1597 1598 I 1599 1600 1601 1602 I 1603 1604 I 1605 1606 1607 I 1608 1609 1610 1611 I 1612 1613 1614 1615 1616 1617 I 1618 I 1619 1620 I I 11/27/1970 11/28/1970 I I I I I II III II II 9/4/1970 11/19/1970 11/18/1970 11/18/1970 7/2/1970 9/1/1998 A N N 8/5/1970 II 11/10/1970 N N II 11/28/1970 NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER VITARINE COMPANY INC SUB WEST CHEMICAL PRODUCTS INC BRISTOL MYERS SQUIBB CO NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER VICTOR M HERMELIN CO DIV K-V PHARMACAL CO BEECHAM PHARMS DIV BEECHAM PRODS BRACCO IND CHIMICA SPA ROUSSEL CORPORATION UNION CARBIDE CORPORATION DOLDER AND CO LTD NITROGLYCERIN 6.5MG SUSTAINED RELEASE CAPS AMPICILLIN TRIHYDRATE TABLESTS 250MG IODAMIDE (METIODID) MESTRANOL METHADONE HCL EFFERVESCENT TABLETS, 40MG TRIAMCINOLONE AND TRIAMCINOLONE ACETONIDE I I 10/30/1970 11/24/1970 I N I 10/26/1970 11/4/1970 10/16/1970 I 10/26/1970 10/24/1970 I I I I I I I IV II III III III II 10/19/1970 10/19/1970 10/16/1970 10/14/1970 10/30/1970 8/13/1970 10/26/1970 10/26/1970 STATUS Type SUBMIT DATE I III II 9/24/1970 10/5/1970 HOLDER QUANTUM CHEMICAL COMPANY DIV VICTOR M HERMELIN CO DIV K-V PHARMACAL CO ALUMINUM COMPANY OF AMERICA ALUMINUM COMPANY OF AMERICA ALUMINUM COMPANY OF AMERICA GIVAUDAN CORPORATION GIVAUDAN CORPORATION SHIONOGI QUALICAPS INC ORGANON INC UNIROYAL IND PRODS INC DIV UNIROYAL INC H REISMAN CORP VICTOR M HERMELIN CO DIV K-V PHARMACAL CO ALLIED CHEM CORP NOT AN ASSIGNED NUMBER PHARMACOSMOS AS VITARINE COMPANY INC SUB WEST CHEMICAL PRODUCTS INC GANES CHEMICALS INC LANNETT CO INC IRON DEXTRAN TABLET MANUFACTURING AND PACKAGING N,N-DIMETHOXYMETHYLPHENOBARBITAL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. SUBJECT POLYETHYLENE RESIN COMPDS NITORA (NITROGLYCERIN) 2.5MG SUSTAINED RELEASE CAPSULES PACKAGING STRUCTURES ALWARP SERIES 9406-9413 ALWRAP 9414 ALWRAP 9007 (COATED ALUMINUM FOIL PAPER) HEXACHLOROPHENE G-4 (DICHLOROPHENE) EMPTY GELATIN CAPSULES MANUFACTURED IN INDIANAPOLIS, INDIANA. SYNTHETIC OXYTOCIN DRUG SOLUTION BOTTLE CAP LINER STRIP PYRAZINAMIDE NITORA (NITROGLYCERIN) 6.5MG DYES AND PIGMENTS

4Q2012

BAKELITE BRAND ETHYLENE ACRYLIC ACID COPOLYMER DRDA-2300 NATURAL 7/ CHLORPROMAZINE HCL

ABBOTT LABORATORIES PHARMACEUTICAL TETRACYCLINE PRODUCTS DIV ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV SAVAGE LABS INC MANUFACTURING PRACTICES NATCON CHEMICAL COMPANY INC NACOM'S PROCESSING & PACKAGING FACILITIES & CONTROLS

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4Q2012EXCEL DMF# 1621 1622 1623 1624 1625 1626 1627 1628 1629 1630 1631 A 1632 1633 1634 1635 1636 I 1637 1638 1639 A 1640 1641 1642 I 1643 1644 1645 1646 1647 1648 1649 1650 1651 1652 1653 1654 I 1655 1656 1657 I I I II III 1/28/1971 1/29/1971 2/19/1971 I I I A I N I I I N N 2/18/1971 II III 2/1/1971 10/26/1970 2/8/1971 III III 1/6/1971 1/26/1971 11/23/1970 12/9/1970 2/2/1971 I I III II 1/15/1971 3/4/1971 12/28/1970 BAKELITE XYLONITE LTD UNITED STATES DEPARTMENT ENERGY USV PHARMACEUTICAL CORP SUB RORER GROUP SHAW MUDGE & CO ALCAN ROLLED PRODUCTS CO ALLIED CHEM CORP CHEVRON PHILLIPS CHEMICAL CO LP ALUMINUM COMPANY OF AMERICA NOT AN ASSIGNED NUMBER GD SEARLE AND CO LANXESS CORPORATION COVINTGON & BURLINGTON NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER ABBOTT LABORATORIES PHARMACEUTICAL MFGR PROCEDS,CTRLS,FACILS & PACKAGING P.RICO PLANT PRODUCTS DIV ORTHO PHARMACEUTICAL CORP ESTRADIOL 17-A-IN PROPYLENE GLYCOL : PARENTERAL HUNTSMAN CHEMICAL CORP MEDWICK LABS INC L-DOPA (OR LEVODOPA) IN BULK ONLY STYRENE ACRYLONITRILE COPOLYMER AMINOFUSIN L600 N I III V 1/11/1971 1/5/1971 I N N I III 1/18/1971 1/27/1971 12/22/1970 TENNECO CHEMICALS INC NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER EDWARD MENDELL CO INC EXPLOTAB-PER CORRES 9.23.77 THIS DHAS BEEN SUPERSEDED BY DMF-3015 MANUFACTURING AND PACKAGING STATUS Type SUBMIT DATE I I I I I A A N I I II I 12/16/1970 12/22/1970 1/5/1971 II III III II III III 11/27/1970 11/19/1970 11/25/1970 12/2/1970 12/7/1970 12/8/1970 12/8/1970 HOLDER BEECHAM PHARMS DIV BEECHAM PRODS DIOSYNTH INC DOW CHEMICAL CO MICHIGAN DIV UNION CARBIDE CORPORATION GENERAL ELECTRIC CO GRAPHIC FLEXIBLE PACKAGING LLC VALSPAR CORP NOT AN ASSIGNED NUMBER FOREST LABORATORIES INC P-L BIOCHEMS INC NATIONAL INSTITUTE DRUG ABUSE SUBJECT PISCATAWAY, N.J. PLANT'S GENERAL OPERATING PROCEDURES SODIUM HEPARIN POLYSTYRENE PRODUCTS, COMPOSITION OF BAKELITE, BRAND POLYETHYLENE RESIN FISSION PRODUCT XENON-133 PRODUCTS IN LCFLEX SERIES RESIN FORMULATIONS

4Q2012

MANUFACTURING SITE,FACILITIES,OPERATING PROCEDURES, AND PERSONNEL. POLYINOSINIC-POLYCYTIDYLIC ACID (STERILE SOLUTION) DELTA-9-TRANS-TETRAHYDROCANNABINOL-DELTA-9-TRANS-TETRAHYDROCANNABINOL

ABBOTT LABORATORIES PHARMACEUTICAL ABBOTT LABS QUALITY ASSURANCE OPERATIONS STANDARDS MANUAL PHARM. DIV. PRODUCTS DIV NOT AN ASSIGNED NUMBER COLE POLYMERS LTD SYNERGY HEALTH STERILISATION UK LTD BEAD COPOLYMER GRADE DISS-120 MESH GAMMA RADIATION STERILIZATION PROCESSES AND FACILITIES AS LOCATED IN SWINDON, ENGLAND DFDG 4250 NATURAL LOW DENSITY POLYETHYLENE GOLD 198 COLLOID (RADIOISOTOPE) (FORMERLY HELD BY UNION CARBIDE CORP) METHODS, FACILITIES AND CONTROLS ALLERDERM INTRUDER M3225 ALUMINUM FOIL PACKAGING R-40 POLYVINYL CHL. SHEET AND R-20A POLYVINYL CHL. SHEET GULF HID 9414, 9406, 9410 RESIN PILFERPROOF CLOSURE (28MM)

POLYSTYRENE PRODUCTS--UNDER TRADE NAME HOSTYREN (FORMERLY TUF-FLEX) FACILITIES AND CONTROLS

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4Q2012EXCEL DMF# 1658 1659 1660 1661 1662 1663 1664 1665 1666 1667 1668 1669 1670 1671 1672 1673 I 1674 1675 1676 1677 1678 1679 1680 1681 1682 1683 A 1684 1685 1686 1687 1688 1689 I 1690 1691 1692 1693 1694 1695 1696 I I N I I N A III 2/26/1971 III 4/20/1971 12/29/1970 II 3/2/1971 1/22/1971 GENERAL ELECTRIC CO CALBIOCHEM CORP NOT AN ASSIGNED NUMBER RT VANDERBILT CO REXENE CORP NOT AN ASSIGNED NUMBER DOW CHEMICAL CO POLYMER/COPOLYMER FORMULATIONS, ADHESIVES INCLUDED VANCIDE FP POLYETHYLENE PE 253 MANUFACTURED IN ODESSA, TEXAS. I I I I I III III II 4/9/1971 4/12/1971 4/9/1971 4/9/1971 3/2/1971 3/2/1971 GANES CHEMICALS INC ACETO CHEMICAL CO INC COMMONWEALTH PACKAGING CORP NASHUA CORP GENERAL ELECTRIC CO GENERAL ELECTRIC CO N I I I I I I I N III 3/18/1971 III I 2/12/1971 3/5/1971 3/12/1971 3/15/1971 11/23/1970 1/22/1971 3/26/1971 STATUS Type SUBMIT DATE I I I I A I I I I I I I I I I V II II I III III IV 3/2/1971 2/1/1971 2/9/1971 2/16/1971 3/19/1971 3/4/1971 3/2/1971 1/15/1971 1/15/1971 12/16/1970 1/22/1971 1/22/1971 1/18/1971 1/19/1971 2/5/1971 12/28/1970 HOLDER DOW CHEMICAL CO MICHIGAN DIV CALBIOCHEM-BEHRING CORP THERMOPLASTIC PROCESSES INC ALCAN ROLLED PRODUCTS CO WATSON STANDARD CO UPJOHN CO ALTANA INC AMERICAN CHEWING GUM INC DOW CORNING CORP SYNTEX USA INC HERCULES INC HERCULES INC ROXANE LABORATORIES INC LINSON LTD MONSANTO COMPANY GOLDSCHMIDT CHEMICAL DIV OF WILSON PHARMA & CHEMICAL CORP NOT AN ASSIGNED NUMBER MERCK SHARP & DOHME RESEARCH LABS CALBIOCHEM-BEHRING CORP DANBURY PHARMACAL INC JWS DELAVAU CO INC GANES CHEMICALS INC CROWN ZELLERBACH CORP NATIONAL STARCH & CHEMICAL CORP NOT AN ASSIGNED NUMBER ALBEA AMERICAS INC SUBJECT DOWICIL 200 PRESERVAIVE DL AND L-5-HYDROXYTRYPTOPHAN, 100MG AND 250MG CAPSULE POLYVINYL CHLORIDE PLASTIC TUBING C-250 VINYL LACQUER LAMINATED FOIL & COATED FOIL LINING FOR ALUMINUM COLLAPSIBLE TUBES #XB-8298 U-32, 070E (25-HYDROXYCHOLECALCIFEROL) MANUF FACILITIES, PERSONNEL AND MANUF. CONTROLS MANUF FACILS, PERSONNEL AND CONTROL INFORMATION PERSONNEL HANDLING NEW DRUG SUBSTANCES NORANDROSTENDIONE (NAD) --METHODS, FACILITIES AND CONTROLS HI-FAX A-60 008 NATURAL (HIGH DENSITY POLYETHYLENE PELLETS) HI-FAX B53-003 NATURAL (HIGH DENSITY ETHYLENE-BUTENE 1 COPOLYMER) STERILE VALIDATION DAA FOR COLUMBUS, OHIO LOCATION DESONIDE SODIUM TRIMETAPHOSPHATE (NAPO3)3

4Q2012

BRONOPOL, A PRESERVAIVE IMPORTED FROM BOOTS PURE DRUG CO.,LTD/ENGLAND

DROCODE BITARTRATE FROM NDA# 11-526 L-TRYPTOPHAN PERSONNEL,FACILITIES AND CONTROLS DESCRIPTION OF PLANT ERIODICTYOL BULK CROWN ZEELON 300P COMPOSITE FILM CONSTRUCTION RESYN 30-1268 GLAMINATE (R) TUBES, MANUFACTURED IN WASHINGTON, NJ, SHELBYVILLE, TE AND CLEVELAND, OH MANUFACTURE OF METHAQUALONE & METHAQUALONE HCL DEXTROPROPOXYPHENE IN BULK CONTRACT PACKAGING OF DRUGS WP-1 AND RX-1 LABEL ADHESIVES IODINE-131 AS SODIUM IODIDE IN SODIUM HYDROXIDE--FISSION PRODUCT MOLYBDENUM-99 AS AMMONIUM MOLYBDATE IN AMMONIUM HYDROXIDE-FISSION PROD MOLYBDENUM-99 AS SODIUM MOLYBDATE IN SODIUM HYDROXIDE--FISSION PRODUCT MANUFACTURING PROCEDURE FOR 5-AZACYTIDINE

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4Q2012EXCEL DMF# 1697 1698 1699 I 1700 1701 I 1702 1703 1704 1705 1706 1707 1708 1709 1710 1711 1712 1713 1714 1715 1716 I 1717 1718 1719 1720 1721 1722 1723 I 1724 1725 1726 1727 1728 1729 1730 1731 1732 1733 1734 I A I I I I I I I I I IV III II III III II 5/28/1971 5/12/1971 6/8/1971 5/25/1971 6/9/1971 6/1/1971 5/28/1971 3/11/1971 6/8/1971 6/8/1971 5/6/1971 I I I I I I I IV I 8/18/1969 5/25/1971 5/25/1971 5/17/1971 4/26/1971 5/17/1971 5/18/1971 I I I I N A I I I I N I I I I II IV 4/28/1971 4/30/1970 5/25/1971 5/25/1971 II III III III 4/16/1971 4/16/1971 4/22/1971 4/23/1971 4/14/1971 II II II 12/17/1970 12/30/1970 4/20/1971 4/14/1971 I III 3/29/1971 12/8/1970 ROBECO CHEMICALS INC ARCO CHEMICAL COMPANY DIV OF ATLANTIC RICHFIELD CO INQUIME INDS QUIMECA ESTENE SA TROPONWERKE GMBH CO KG PFIZER INC CALIF RADIOCHEMICALS INC NOT AN ASSIGNED NUMBER DOW CHEMICAL CO REXHAM CORP JOHN DICKINSON & COMPANY LTD SSL INTERNATIONAL EASTMAN CHEMICAL CO NOT AN ASSIGNED NUMBER LILLY RES LABS DIV ELI LILLY CO GIVAUDAN ROURE CORP AMCON INDUSTRIES INC INSULIN DRUG SUBSTANCES FLAVORS AMGLO FILM COATING BASE EXPERIMENTAL FILM PZ-2005.07 RPL-1 POUCHES SUPPLIED TO NORTH HILL PLASTICS, LTD. STATUS Type SUBMIT DATE I A II III I 3/11/1971 3/29/1971 3/26/1971 HOLDER GANES CHEMICALS INC EQUISTAR CHEMICALS LP KEMWORTH LABS INC SUBJECT SODIUM THIAMYLAL FOR INJ MANUF BY SIEGFRIED LTD, SWITZERLAND PRO-FAX NATURAL POLYPROPYLENE MATERIALS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF CUSTOM LYPHILIZATION OF DRUGS FORHUMAN USE SPERMWAX

4Q2012

DYLAN POLYETHYLENE 1020 F-40 RESIN COMPOUNDS-MANUF PLASTIC BOTTLES PHENYLBUTAZONE USP BUPHENINE HCL(NYLIDRIN) TINIDAZOLE BULK EXTRACTION OF TC-99M FROM MO-99 SOURCE

CHLORHEXIDINE GLUCONATE 20% SOLUTION MANUFACTURED IN BRISTOL, UK TENITE POLYETHYLENE 1572E-60804, WHITE

BEECHAM PHARMACEUTICALS UK DIVISION MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. ESSCHEM CO DIV SARTOMER RESINS INC ETHYLENE GLYCOL DIMETHACRYLATE BILCHEM LTD SERVASSEM DIV METAL EDGE INDS PHYSIOLOGICAL POLYMERS INC NORTHVILLE LABORATORIES CALBIOCHEM-BEHRING CORP MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC DOW CORNING CORP DOW CHEMICAL CO FLUID CHEM CO U.S. DEPARTMENT OF ENERGY AMERICAN CYANAMID CO RP SCHERER CORP TARO VIT CHEMICAL INDS FERRO CORP WITCO CHEM CO INC GEMA SA STEPAN CHEMICAL COMPANY GEN OPER PROCEDS OF WESTERN FHER LABORATORIES, INC. FACILITIES & CONTROL USED IN PACKAGING & LABELS OF DRUGS P.H.P. POLYMER FORMULATION FOR CINNAMON EXTRACT INOSINNE (CALBIOCHEM CA. #800101) MANUF&CONTROL FACILITIES&PROCEDURES AT SUBSIDIARY PLANT BARCELONETA,PR SILASTIC 1808 ELASTOMER DOW POLYETHYLENE RESINS COMPOUNDING OR PACKAGING RADIOISOTOPE MOLYBDENUM-99-P-4 (FORMERLY HELD BY UNION CARBIDE CORP) DIOCTYL CALCIUM SULFOSUCCINATE DIOCTYL SODIUM SULFOSUCCINATE 100MG & GASANTHRANOL 30MG. CAPSULES. CHLORPROMAZINE HCL STABILIZER FOR VINYL PLASTICS, FERRO 760X, 765B, 5376, 5650 NON-TOXIC VINYL STABILIZERS, MARK 577A, MARK 152, MARK 329 NITROFURANTOIN U.S.P SUPER-PRO 5A, AND SURFA M-801

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4Q2012EXCEL DMF# 1735 1736 1737 1738 1739 1740 1741 1742 1743 1744 I 1745 1746 1747 1748 1749 1750 1751 1752 1753 1754 1755 1756 1757 1758 1759 1760 I 1761 1762 I 1763 1764 1765 1766 1767 1768 1769 1770 1771 1772 1773 I I I I I N I I I I I II 7/26/1971 7/26/1971 7/26/1971 7/29/1971 8/2/1971 II I III II I 7/19/1971 6/28/1971 7/27/1971 7/28/1971 6/28/1971 I III 7/9/1971 7/14/1971 I A I A I I I I I I I I I I N III 7/14/1971 IV II II II III III 2/9/1971 6/18/1971 6/16/1971 6/21/1971 6/17/1971 2/3/1971 6/29/1971 6/29/1971 6/25/1971 6/29/1971 7/2/1971 6/23/1971 6/21/1971 5/24/1971 STATUS Type SUBMIT DATE I I I I I I I I I II II III IV IV I II 4/20/1971 5/13/1971 6/10/1971 6/10/1971 1/18/1971 6/15/1971 6/14/1971 6/15/1971 6/7/1971 6/21/1971 HOLDER GIVAUDAN CORPORATION UNIVERSAL FOODS CORP DUPONT PHARMACEUTICALS CO SYNTEX USA INC EI DUPONT DE NEMOURS AND CO ER SQUIBB AND SONS INC TARO VIT CHEMICAL INDS AMERICAN CYANAMID CO DRAGOCO INC PREMO PHARMACEUTICAL LABORATORIES INC FELTON WORLDWIDE INC NATIONAL NOVELTY BRUSH AVICON INC SANOFI CHIMIE AMETEK-WESTCHESTER PLASTICS DELMAR CHEMS LTD DELMAR CHEMS LTD REXOLIN CHEMS AB MONSANTO COMPANY UPJOHN CO KETCHUM LABORATORIES INC BANNER PHARMACAPS INC WELLCOME FOUNDATION LTD HEINRICH MACK NACHF NOT AN ASSIGNED NUMBER ANCHOR CAP & CLOSURE CORP OF CANADA LTD INEOS ACRYLICS UK LIMITED VICTOR M HERMELIN CO DIV K-V PHARMACAL CO ORGANON SUB AKZONA INC MAURRY BIOLOGICAL CO INC NORTHERN PETROCHEMICAL COMPANY ORGANON SUB AKZONA INC LYPHOMED INC NOT AN ASSIGNED NUMBER AS SYNTHETICS LA QUINOLEINE HEINRICH MACK NACHF AMERICAN CYANAMID CO CUTTER BIOL DIV MILES LABS INC PHENYLBUTAZONE 5-CHLORO-8-HYDROXYQUINOLINE (CHLOROHYDROXYQUINOLINE) 5-IODO-2'-DEOXY-URIDINE STERWIN COMPOUND 904 NORTON PLASTIC S-500-304 CLOSURES FOR CONTAINERS (METAL SCREW CAP) METHYL METHACRYLATE BONTRIL #1 TIMED TABLETS AND BONTRIL #2 TIMED TABLETS PROGESTERONE MANUFACTURE, PROCESSING AND PACKAGING DRUGS NORCHEM LOW DENSITY POLYETHYLENE NPE 80 ANDROSTERONE MANUFACTURING FACILITIES AND OPERATIONAL CONTROLS SUBJECT FLAVORINGS FORMULATIONS FOR FLAVORINGS AND COLORANTS PERSONNEL, FACILITIES AND CONTROLS MEGESTROL ACETATE TEFLON: FLUOROCARBON RESINS MYCOSTAIN (NYSTATIN) CHLORPROMAZINE HCL UREA-FORMALDEHYDE RESIN (BEETLE MUP-01) MICROSEAL IMITATION ORANGE-PINEAPPLE FLAVOR GENERAL PLANT AND MANUF PROCEDURE FELCOFIX IMITATION PINEAPPLE #952 (CODE #10650) COMPRESSION-MOLDED CLOSURES AVITENE R COLLAGEN DEXAMETHASONE MANUFACTURED IN VERTOLAYE, FRANCE WHITE UNICOLOR (POLYETHYLENE COLOR CONCENTRATES) METHAQUALONE BASE AND METHAQUALONE HCL CHLORPROMAZINE HCL MEPROBAMATE L-3-O-METHYLDOPA (U-31, 583) 1-B-D-ARABINOFURANOSYLCYTOSINE 5'-PALMITATE FACILITIES, CONTROL AND PERSONNEL SOFT GELATIN CAPSULES COMPOUND 57C65 CYTOSINE-ARABINOSIDE HCL & CYSTOSINE-ARABINOSIDE FREE BASE

4Q2012

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4Q2012EXCEL DMF# 1774 1775 1776 1777 1778 1779 1780 1781 1782 1783 I 1784 1785 1786 1787 1788 1789 1790 1791 1792 1793 1794 1795 1796 I 1797 1798 1799 1800 1801 I 1802 1803 1804 1805 1806 1807 1808 1809 1810 1811 1812 I I I I I I I I I I I I I II II II II II 9/21/1971 9/27/1971 9/24/1971 9/24/1971 9/20/1971 9/29/1971 8/24/1971 9/30/1971 10/18/1971 10/14/1971 10/19/1971 MALLINCKRODT INC H LUNDBECK AND CO AS TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD LUDLOW FLEXIBLE PACKAGING REGIS CHEM CO CENTERCHEM INC DELMAR CHEMS LTD TERA PHARMS INC FISONS CORP I I I I II I III 9/20/1971 10/27/1970 9/20/1971 9/20/1971 9/22/1971 COLAB LABS INC FLINT HILLS RESOURCES LP RP SCHERER CORP CIBA GEIGY CORP UNIT PACK COMPANY INC I I I I I N N I I I I I I III III II 9/13/1971 9/15/1971 9/16/1971 9/16/1971 9/13/1971 9/9/1971 II II I 9/2/1971 9/7/1971 9/7/1971 9/13/1971 9/13/1971 STATUS Type SUBMIT DATE I I I I I I I I I II II II 8/2/1971 8/9/1971 8/9/1971 8/9/1971 8/10/1971 8/17/1971 8/21/1971 8/16/1971 9/1/1971 9/2/1971 HOLDER ELI LILLY AND CO CROMPTON AND KNOWLES CORP TANABE SEIYAKU CO LTD GOTHAM PHARMACEUTICAL COMPANY INC ACETO CHEMICAL CO INC PCR INC FREDERIKSBERG CHEM LABS LTD BURJON INC CYCLO CHEM CO SUBJECT ASPIRIN CAPSULES 325MG SALICYLAZOSULFAPYRIDINE SODIUM THIOPENTAL INJECTION METHODS, FACILITIES AND CONTROLS IMIPRAMINE HCL IN BULK CHLORPROMAZINE HCL CORTICOTROPIN (ACTH) PACKAGING OF TOPICAL POWDERS CYCLOCHEM SPS

4Q2012

ABBOTT LABORATORIES PHARMACEUTICAL METHAPYRILENE HCL PRODUCTS DIV WYETH INC MANUFACTURING FACILS A HAVANT PLANT, HAMPSHIRE, ENGLAND US ATOMIC ENERGY COMMISSION BURDICK & JACKSON LABS,INC MANUFACTURING CHEMISTS INC AMERICAN CYANAMID CO NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NAPP-LEMKE CHEMS INC RP SCHERER CORP AMERICAN NATIONAL CAN CO AMERICAN NATIONAL CAN CO MIRANOL CHEM CO ALDRICH CHEMICAL COMPANY INC ISOSORBIDE DINITRATE CAPSULES VITAMIN D, 50,000 UNITS (1.25MG) CONOLAM 5000 PACKAGING MATERIAL (FORMERLY HELD BY CONTINNETAL CAN CO CONOLAM 6000 PACKAGING MATERIAL (FORMERLY HELD BY CONTINENTAL CAN CO MIRANOLC2M CONCENTRATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WISCONSIN. CALGITEX PRODUCTS POLYETHYLENE PE102 MANUFACTURED IN ODESSA, TEXAS. CAPSULES VIT. A, 50,000 UNITS (15.0MG) AND 100,000 UNITS (30.0MG) 2(2'-HYDROXY-5-METHYLPHENYL) BENZOTRIAZOLE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. METHADONE HCL FLAVORED CONCENTRATE LU 3-010 L-ALANINE L-PROLINE L-SERINE PACKAGING MATERIALS 6-HYDROXYDOPAMINE (6-OHDA) METHSCOPOLAMINE BROMIDE, N.F. XIII GENERAL INFORMATION ON FACILITIES & CONTROL FACILS CONTROLS AND PERSONNEL FACILITIES, CONTROLS, EQUIP & PERSONNEL (INTAL) 12 RADIOISOTOPE PRODUCTS METHDILAZINE; METHDILAZINE HCL FACILITIES AND PERSONNEL CYASORB UV-9---SPECTRA-SORB

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4Q2012EXCEL DMF# 1813 1814 1815 1816 1817 1818 1819 1820 1821 1822 1823 1824 I 1825 1826 1827 1828 1829 1830 1831 1832 1833 1834 1835 1836 1837 1838 1839 1840 1841 1842 1843 1844 A 1845 1846 1847 1848 I 1849 1850 I I III 1/7/1972 11/15/1971 I I A II III 12/28/1971 12/22/1971 1/4/1972 12/15/1971 A I I I I I I I I I I I I I A I I I I IV IV III II IV II II II II II II III II III 11/29/1971 12/6/1971 12/6/1971 12/6/1971 11/22/1971 12/9/1971 12/17/1971 12/17/1971 12/17/1971 11/22/1971 12/6/1971 12/3/1971 12/22/1971 11/24/1971 12/16/1971 11/22/1971 12/6/1971 12/14/1971 12/30/1971 12/22/1971 SPECIALTY COATING SYSTEMS INC ALLIED CHEM CORP SUMITOMO CHEMICAL CO LTD DREVCO CORP SIGMA CHEM CO TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD HOECHST CELANESE CORP TANABE SEIYAKU CO LTD REXENE CORP FISONS CORP GUTMANN PLASTICS INC COPPERHEAD INVESTMENTS INC SARTOMER RESINS INC ESSCHEM CO DIV SARTOMER RESINS INC ROBECO CHEMICALS INC COOPER LABORATORIES INC PHARMACEUTICAL FLAVOR CLINIC DIV FOOTE AND JENKS LETRASET LTD ROUSSEL CORPORATION DOW CHEMICAL CO BEECHAM-MASSENGILL PHARMS DIV BEECHAM INC SIMKINS INDS INC DEWEY AND ALMY CHEM DIV WR GRACE AND CO BAKELITE BRAND PARAYLENE N AND C PHENYLBUTAZONE AC - 485 MICROBEADS DESCRIPTION OF OUR PLANT AND FACILITIES CARBAMYL PHOSPHATE, DILITHIUM SALT L - TYROSINE ETHYLESTER MONOHYDROCHLORIDE DL - METHIONINE L-GLUTAMINE FUROSEMIDE L-LYSINE MONOHYDROCHLORIDE POLYETHYLENE RESIN PE 117 MANUFACTURED IN ODESSA, TEXAS. CROMOLYN SODIUM/LACTOSE BLEND PACKAGING MATERIALS AS MFG IN BROOKLYN, NEW YORK STATUS Type SUBMIT DATE I I I I A I I I I I I II II II II III IV II II II III 10/18/1971 10/22/1971 10/20/1971 10/22/1971 11/21/1971 11/21/1971 11/2/1971 11/10/1971 11/17/1971 11/12/1971 11/22/1971 11/29/1971 HOLDER KV PHARMACEUTICAL CO LILLY RES LABS DIV ELI LILLY CO CALBIOCHEM-BEHRING CORP OLIN CHEMICAL CORP PHARMACIA AND UPJOHN SUB PFIZER INC EMERY IND INC EGON MEYER SA GLAXO LABS LTD ABBOTT LABORATORIES GYMA LABORATORIES OF AMERICA INC BF GOODRICH COMPANY SUBJECT ORTHO-NOVUM 1/5OE21 IRON BILE SALTS CAPSULES URIDINE

4Q2012

OMADINE MDS (MAGNESIUM SULFATE ADDUCT OF PYRIDINETHIONE DISULFIDE) MEGESTROL ACETATE PLASTOLEIN 9250 EMAPLAST 812 CEPHALEXIN SUCCINYLCHOLINE CHL MANUFACTURE PROPOXYPHENE HYDROCHLORIDE RUBBER COMPOUNDS 117254, 59386-F

CARROLL CHEM CO DIV SPERTI DRUG CORP STANDARD OPERATING PROCEDURE

CHEMICAL CORPORATION OF AMERICA INC CADOX BCP - SILICA - TALC

SDM-17 (10% NITROGLYCERIN IN LACTOSE) MANUFACTURED IN TAMAQUA, PA SR 205, TRIETHYLENE GLYCOL DIMETHACRYLATE SR-240-2-HYDROXYETHYL METHACRYLATE CETINA PLIAGEL (TM) CONTACT LENS CLEANER FLAVOR FORMULATIONS LABEL FOR INCORPORATION IN BLOOD BAG NORETHINDRONE ACETATE BAKELITE BRAND POLYETHYLENE RESIN AMPICILLIN TRIHYDRATE (PEDIARIC DROPS) FACILITIES, ANDMANUFACTURE PROCEDURES THERMOPLASTIC COATINGS---TC AMR 12; TC AMR 22; AND TC AMR 44

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4Q2012EXCEL DMF# 1851 1852 1853 1854 1855 1856 1857 1858 1859 1860 1861 1862 1863 1864 1865 1866 1867 1868 1869 1870 1871 1872 1873 1874 1875 1876 1877 1878 1879 1880 1881 1882 1883 1884 1885 1886 1887 1888 1889 1890 1891 STATUS Type SUBMIT DATE I I I I A I I I I A A A I I I I I A A A I I I I I I I I A I I I I I I I I I I I A II II I IV IV III II III II IV III II II II I II I III II 12/14/1971 1/10/1972 12/17/1971 1/12/1971 1/7/1972 7/17/1969 1/17/1972 1/18/1972 1/20/1972 1/26/1972 1/26/1972 1/25/1972 2/4/1972 2/2/1972 1/17/1972 1/19/1972 2/8/1972 1/28/1972 12/5/1971 10/20/1971 2/14/1972 2/14/1972 2/23/1972 2/25/1972 2/22/1972 2/24/1972 3/1/1972 2/27/1972 2/25/1972 2/27/1972 3/3/1972 3/6/1972 3/8/1972 3/7/1972 3/7/1972 3/7/1972 3/7/1972 3/8/1972 3/10/1972 3/8/1972 7/21/1971 HOLDER UNION CARBIDE CORPORATION BORDEN CHEM CO SHANKMAN LABS DUPONT DENEMOURS & CO EUTICALS LIMITED ALCOLAC CHEM CORP PALMER RESEARCH LABS BARGER PACKAGING CORP BURTON,PARSONS & COMPANY,INC. CAMBREX PROFARMACO MILANO SRL CAMBREX PROFARMACO MILANO SRL MALLINCKRODT INC CINTICHEM INC CALBIOCHEM-BEHRING CORP EASTMAN CHEMICAL CO HOOKER CHEM CORP PARKE DAVIS & CO EASTMAN CHEMICAL CO TEVA PHARMACEUTICAL INDUSTRIES LTD DOW CHEMICAL CO AMERICAN BIO SYNTHETICS CORP MEDI PHYSICS INC PARKE DAVIS & CO PHARMACHEM CORP FANSTEEL METALS DIV FANSTEEL INC PACKAGING COORDINATORS INC DOW CHEMICAL CO MICHIGAN DIV BIO NUCLEAR INC SYMRISE INC BIO NUCLEAR INC DEXTER CORPORATION GANES CHEMICALS INC SYNCOR INTERNATIONAL CORP BIO NUCLEAR INC HASTINGS RADIOCHEMICAL WORKS HASTINGS RADIOCHEMICAL WORKS BIO NUCLEAR INC MEDI PHYSICS INC UNIV OF WISCONSIN CIBA GEIGY CORP DOW CORNING CORP SUBJECT TERGITOL MONIONIC SURFACTANT 12-M-10 2-HYDROXYETHYL METHACRYLATE FACILITIES AND PERSONNEL TYVEK SPUNBONDED OLEFIN ISOSORBIDE DINITRATE BULK SIPOMER HEM (HYDROXYETHYL METHACRYLATE ISOSORBIDE DINITRATE TRITURATE PACKAGING FACILITIES AND CONTROL BOILSOAK---BUFFERED NORMAL SALINE SOLUTION NITROFURANTOIN MACROCRYSTALS NITROFURANTOIN NALOXONE HCL USP DIHYDRATE (ESUB) AS MANUFACTURED IN ST LOUIS MO

4Q2012

MANUFACTURING FACILS.-(THIS DFORMERLY HELD BY UNION CARBIDE CORP) GAMMA-HYDROXYBUTYRIC ACID SODIUM SALT TENITE ACETATE 036E-00969-H2 DODECYL MERCAPTAN HYDROGEN PEROXIDE SOLUTION 3% EASTMAN DOP PLASTICIZER PROBENECID METHOCEL METHYLENE CASEIN-ESMA TAB NO. 609 SPECIFICATION AND PLANT PROCEDURES IN MANUFACTURING METHAQUALONE HYDROCHLORIDE & METHAQUALONE BASE EXTRACELLULAR WATER SOLUTION (ECWASOL) TANTALUM MEDICAL POWDER PACKAGING OPERATIONS IN PHILADEPHIA, PA POLYTHIOL RESIN MANUFACTURING FACILITIES IN DALLAS TEXAS FLAVORS MANUFACTURING FACILITIES HIALEAH FLORIDA V-1243 AND V-1269 COATING MATERIALS. HEXAFLUORENIUM BROMIDE FACILITIES AND SUPERVISORY PERSONNEL FACILITIES AND SUPERVISORY PERSONNEL, TEXAS PLANT PLANT FACILITIES, FLORIDA FACILITIES AND SUPERVISORY PERSONNEL, DALLAS PLANT FACILITIES AND SUPERVISORY PERSONNEL N.O. PLANT 99M TC-PERTECHNETATE-SULFUR COLLOID 1,25-DIHYDROXYCHOLECALCIFEROL PERSONNEL MDX-4-4159 FLUID

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4Q2012EXCEL DMF# 1892 I 1893 1894 1895 1896 1897 1898 1899 1900 1901 1902 I 1903 1904 1905 1906 1907 1908 1909 1910 1911 1912 1913 1914 1915 I 1916 1917 1918 1919 1920 1921 1922 1923 1924 1925 1926 1927 1928 1929 1930 I I I I I I I I I I I I I I I II II II III I II III I 4/5/1972 4/14/1972 4/17/1972 4/17/1972 4/17/1972 4/20/1972 4/27/1972 5/1/1972 5/1/1972 5/1/1972 5/3/1972 4/7/1972 5/9/1972 5/9/1972 5/9/1972 I I I A I I I I I I I I II II I II II II 3/16/1972 3/26/1972 3/8/1972 3/8/1972 3/7/1962 3/27/1972 3/27/1972 3/28/1972 4/4/1972 4/10/1972 4/5/1972 4/12/1972 4/12/1972 A I I I N I I I I III II 3/21/1972 3/1/1972 1/5/1971 2/2/1972 3/20/1972 II III 3/14/1972 3/20/1972 7/11/1986 3/24/1972 STATUS Type SUBMIT DATE I 3/14/1972 HOLDER PFIZER PHARMS DIV CHAS PFIZER AND CO INC PERFECSEAL INC AMERICAN LABS GEDEON RICHTER LTD CEDONA HAARL PHARM FABRIEK NV NOT AN ASSIGNED NUMBER BIP CHEMICALS LTD TANABE SEIYAKU CO LTD F RITTER & CO ETHYL CORP PIERCE & STEVENS CHEMICAL CORPORATION PUERTO RICO PLASTIC PRODUCTS CO INC BAKELITE XYLONITE LTD PLANTEX LTD CHEM AND PHARM WORKS TEVA PHARMACEUTICAL INDUSTRIES LTD PLANT INDUSTRIES INC AMERICAN CAN ALLIED CHEM CORP PARKE DAVIS & CO GANES CHEMICALS INC WHATMAN BIOCHEMS LTD LUNDBECK PHARMACEUTICALS ITALY SPA TROPONWERKE GMBH CO KG SCHERING CORP SUB SCHERING PLOUGH CORP AMOCO CORP SANOFI WINTHROP INC TRAVENOL LABORATORIES INC WARNER LAMBERT CO ROUSSEL CORPORATION MONSANTO COMPANY CUTTER LABORATORIES INC ELI LILLY AND CO RP SCHERER CORP RP SCHERER CORP HELVOET PHARMA NV BADISCHE ANILIN UND SODA FABRIKEN AG TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD UREA-FORMALDEHYDE MOULDING GLYCINE (AMINOACETIC ACID) IMITATION VANILLA CONCENTRATE 20 X #20 ETHYL 8237 POLYVINYL CHLORIDE PROXMELT A-4624 FORTIFLEX B54-25H BAKELITE POLYETHYLENE DND2450 NATURAL & PX527/1 NATURAL L - DOPA IMIPRAMINE HYDROCHLORIDE SELVAC CONTAINERS PLASTIC BOTTLES HYDRALAZINE HCL CI -404 - ACTINOBOLIN SULFATE 8 - BROMOTHEOPHYLLINE SODIUM CELLULOSE PHOSPHATE IMIPRAMINE HYDROCHLORIDE GLUTETHIMIDE FACILITIES A KENILWORTH, NEW JERSEY AMOCO'S POLYPROPYLENE RESINS FOR DRUG PACKAGING MANUFACTURING FACILITIES AND CONTROLS POLYOLEFIN (PL325 PLASTIC) CONTAINERS MANUFACTURING, FACILITIES, CONTROLS NORETHINDRONE POLYVINYL CHL PLASTIC - VYRAM 2830,2831, 2880 CONCENTRATED PERITONEAL DIALYZING SOLUTIONS WITH SORBITOL NITROGLYCERIN AMPOULES OXYPHENBUTAZONE CAPSULE 100MG PHENYLBUTAZONE CAPSULES 100MG BUTYL RUBBER STOPPER FM 50 LUTONAL I 30 POLY (ISOBUTYL VINYL ETHER) L-TYROSINE L-ARGININE BASE L-CYSTEINE MONOHYDROCHLORIDE MONOHYDRATE SUBJECT DESCRIPTION OF FACILS AND PERSONNEL OF DEVELOPMENTAL RESEARCH PAPER & VINYL ADHESIVE COATING COENZYME I-10 ETHYNODIOL DIACETATE AS MFG. IN BUDAPEST, HUNGARY CEDOCARD TABLETS (ISOSRBIDE NITRATE)

4Q2012

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4Q2012EXCEL DMF# 1931 1932 1933 1934 1935 1936 1937 1938 1939 1940 I 1941 A 1942 1943 I 1944 1945 1946 1947 1948 1949 1950 1951 1952 1953 1954 1955 1956 1957 1958 1959 1960 1961 1962 I 1963 A 1964 1965 I 1966 I I 7/17/1972 I 7/11/1972 7/17/1972 III 6/20/1972 EQUISTAR CHEMICALS LP A LYONDELLBASELL INDUSTRIES CO MINN 3M LABS LTD DEWEY AND ALMY CHEM DIV WR GRACE AND CO PFIZER INC PRO-FAX 6528 NATURAL POLYPROPYLENE (FORMERLY HELD BY HERCULES) METHAGUALONE AND METHAGUALONE HYDROCHLORIDE DAREX EXPERIMENTAL COMPOUND H-1453 QUALITY CONTROL INFORMATION FOR NDA ANTIBIOTIC I I I I I A I I I I I I I N I I I I III IV III 6/30/1972 6/30/1972 7/6/1972 6/30/1972 6/20/1972 II II II I 6/5/1972 6/5/1972 5/24/1972 6/7/1972 6/9/1972 6/9/1972 6/14/1972 6/14/1972 6/14/1972 6/19/1972 6/19/1972 6/19/1972 6/23/1972 I III 6/1/1972 6/5/1972 INTERNATIONAL SPECIALTY PRODUCTS III 5/30/1972 AMCOR FLEXIBLES SINGEN GMBH STATUS Type SUBMIT DATE I I A I I I I I A III II II IV III II 5/9/1972 5/16/1972 11/15/1971 5/15/1972 5/18/1972 5/22/1972 5/15/1972 5/17/1972 5/18/1972 5/31/1972 HOLDER TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD DRUG PLASTICS AND GLASS CO INC NAPP CHEMICALS INC DOLDER AND CO LTD ELI LILLY AND CO TANABE SEIYAKU CO LTD MINN 3M LABS LTD ABITEC CORP SUBJECT L-HISTIDINE BASE L-ASPARAGINE MONOHYDRATE PLASTIC BOTTLES PROBENECID, USPXVIII IMIPRAMINE HCL POLYETHYLENE PLASTIC BOTTLES L-LYSINE ACETATE ISOETHARINE SALTS INCLUDING ISOETHARINE MESYLATE SYNTHETIC VEGETABLE OILS--CAPTEX 200, 300, & 350

4Q2012

INTERNATIONAL MEDICATION SYSTEMS LTD MANUFACTURING PROCEDURES LACQUER FORMULAE AND FOIL COMBINATIONS (ESUB) AS MANUFACTURED IN SINGEN GERMANY N-VINYLPYRROLIDONE

YOSHITOMI PHARMACEUTICAL INDUSTRIES CHLORPROMAZIN HCL LTD CLARKOTE CHEMICAL CO INC HEAT SEAL VINYL COATING #1098 GELMAN INSTRUMENT CO GLAXO WELLCOME INC ICN NUTRITIONAL BIOCHEMS DIV LABORATORI DERIVATI ORGANICI SANOFI CHIMIE ACETO CHEMICAL CO INC DELUCA HECTOR F PHD DELUCA HECTOR F PHD AUTOMATED OPTICS INC EI DUPONT DE NEMOURS AND CO NAPP CHEMICALS INC CONSUPAK INC NOT AN ASSIGNED NUMBER REHEIS CHEM CO DIV ARMOUR AND CO EASTMAN KODAK CO NATL PATENT DEVELOPMENT CORP UNION CARBIDE CORPORATION BASELL USA INC BASIC ALUMINUM BROMIDE N,N- DIMETHYL - P -TOLUIDINE HYDRON TM BIOMEDICAL POLYMER TYPE N CELLOSIZE HYDROXYETHYL CELLULOSE PRO-FAX 6313;6413;6513 NATURAL POLYPROPYLENE(FORMERLY HELD BY HERCULES MEDICAL INSTRUMENTATION--MEMBRANE FILTERS & RELATED EQUIP. FACILITIES & CONTROLS OF THE WELLCOME FOUNDATION IN KENT ENGLAND L PROLYL L LEUCYL GLYCINE AMIDE (L PLGA) SODIUM HEPARIN PROMETHAZINE HCL PROPANTHELINE BROMIDE BULK 5, 6 - TRANS-VITAMIN D3 5,6 - TRANS - 25 - HYDROXYVITAMIN D3 N-VINYL-2-PYRROLIDONE (N-VP); 2-HYDROXYETHYL METHACRYLATE (HEMA) 1. TYZOR TE ORGANIC TITANATE2.TYZOR TPT PROMETHAZINE HCL (THIS DORIG HELD BY VITAMERICAN CORP BY DOLDER LTD CONSUPAK BRAND POLYETHYLENE BOTTLES

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4Q2012EXCEL DMF# 1967 1968 1969 1970 1971 1972 1973 1974 1975 1976 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 I 2006 A IV 10/23/1972 STATUS Type SUBMIT DATE I A I I A I I I I I I I I I I N I I A I I I I I A I I I I N I I N I I I I I II 9/29/1972 9/29/1972 9/29/1972 10/5/1972 8/14/1972 10/6/1972 III 9/14/1972 7/31/1972 II III II II IV II II II 8/10/1972 8/11/1972 8/16/1972 8/25/1972 8/25/1972 8/28/1972 8/30/1972 9/1/1972 8/7/1972 9/7/1972 9/9/1972 9/18/1972 9/20/1972 I II IV III IV II V III III 2/20/1970 7/17/1972 7/21/1972 7/24/1972 7/24/1972 7/27/1972 7/27/1972 8/2/1972 7/1/1972 7/24/1972 7/28/1972 7/10/1972 8/4/1972 8/8/1972 8/16/1972 HOLDER P ROBERTET INC TEKNI PLEX INC GANES CHEMICALS INC UPJOHN CO WATSON STANDARD CO ASHLAND CHEM CO DIV ASHLAND OIL INC EASTMAN KODAK CO PHENCHEM INDUSTRIES LTD TITE PAK INC SANOFI AVENTIS DEUTSCHLAND GMBH SCHERER HARTKAPSEL GMBH EQUISTAR CHEMICALS LP LILLY RES LABS DIV ELI LILLY CO LILLY RES LABS DIV ELI LILLY CO TRAVENOL LABORATORIES INC NOT AN ASSIGNED NUMBER VERNAY LABORATORIES INC MINN 3M LABS LTD BAYER PHARMA AG BURTON,PARSONS & COMPANY,INC. BURTON,PARSONS & COMPANY,INC. SEARLE M AND T CHEMS INC SUB AMERICAN CAN TANABE SEIYAKU CO LTD GLENROY INC SWORDS LABORATORIES LTD TANABE SEIYAKU CO LTD SHIONOGI AND CO LTD ASHLAND CHEM CO DIV ASHLAND OIL INC NOT AN ASSIGNED NUMBER GIST BROCADES WEST PHARMACEUTICAL SERVICES INC NOT AN ASSIGNED NUMBER CLINTON CORN PROCESSING CO ROUSSEL CORPORATION MIDLAND DIVISION DEXTER CORPORATION AMERICAN CYANAMID CO GIVAUDAN CORPORATION SYNTEX LABORATORIES INC SUB SYNTEX CORP DOW CORNING CORP HIGH FRUCTOSE CORN SYRUPS CHENODEOXYCHOLIC ACID V-746 VALVE COATING, V-804 CLEAR TOPCOA ABATE INSECTICIDE CHERRY FLAVOR F232 FACILITIES AND METHODS DOW CORNING MEDICAL ADHESIVE A (SILASTIC MED ADHESIVE SILICONE A) HYDROCORTISONE BULK ACRYLONITRILE RESINS: TYRIL 867 SERIES VL201N25 & VL201X22 COMPOUNDS ISOETHARINE HCL USP & NUMOTAC TABLETS WITH ISOETHARINE HCL ETHINYL ESTRADIOL FLEXSOL CLEANING SOLUTION PREFLEX, NORMAL--FLEXSOL CLEANING & STORAGE SOLUTION NORTHINDQONE, MESTRANOL, MEDROXYPROGESTERONE APOSET 445P AMINO ACID MIXTURE PACKAGING FILMS FLUPHENAZINE DECANOATE L-GLUTAMIC ACID 2A,3A-EPITHIO-5A-ANDROSTAN-17B-OL (10275-S) EPITIOSTANOL 5,7-DICHLORO-8-HYROXYQUINOLINE SUBJECT DERMODOR 4775 FLEXIBLE LAMINATES MANUFACTURED IN FLEMINGTON, NEW JERSEY. PROBENECID ARA-CYTIDINE 5 - BENZOATE (U - 32,072E) LACQUER PE-1090-21 5-CHLORO-8-HYDROXYQUINOLINE GLYCOLIDE PROMETHAZINE HYDROCHLORIDE PERSONNEL FACILITIES AND CONTROL D-PROPOXYPHENE HYDROCHLORIDE BULK EMPTY GELATIN CAPSULES (HARD SHELL) NORCHEM'S POLYETHYLENE RESIN NPE-810--PRODUCTION & SPECS FOR COMPOUND 56997-SWEETENING AGENT (TETRAZOLE) STERAPS SULFATHIAZOLE 2.5GM, 5GM STERILITY TESTING OF LARGE VOLUME PARENTERAL SOLUTION

4Q2012

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4Q2012EXCEL DMF# 2007 2008 2009 I 2010 2011 I 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 I 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 I 2039 2040 2041 2042 2043 2044 I I I I I A II III 1/15/1973 1/15/1973 12/4/1972 1/15/1973 2/1/1973 2/1/1973 I I I I I I A I I A I I I I II II II II II II II I 12/1/1972 12/5/1972 12/14/1972 12/14/1972 12/14/1972 12/22/1972 12/18/1972 12/18/1972 12/11/1972 12/22/1972 12/26/1972 12/28/1972 1/3/1973 1/5/1973 1/10/1973 I I I I I I I I I I I III II II I I II 9/8/1972 10/30/1972 10/17/1972 10/13/1972 11/3/1972 10/16/1972 11/21/1972 11/20/1972 11/10/1972 11/22/1972 11/24/1972 12/4/1972 I II 10/26/1972 10/30/1972 STATUS Type SUBMIT DATE I I I IV 9/28/1972 10/25/1972 10/26/1972 HOLDER FOREST PHARMACEUTICALS INC WR GRACE SUBJECT

4Q2012

PERSONNEL,FACILITIES,CONTROLS (DFORMERLY HELD BY WESTERFIELD LABS) X-PAL CONTACT LENS POLISH

AYERST LABORATORIES INC DIV AMERICAN INDERAL HOME PRODUCTS CORP ORGANON INC NORETHISTERONE USV LABORATORIES INC SUB RORER GROUP ADAMHA NIMH MALLINCKRODT INC PFIZER PHARMS INC CONTINENTAL CAN COMPANY SCHERING AG ACETO CHEMICAL CO INC SIEGFRIED AG ATLANTIC RICHFIELD CO UNITED STATES DEPARTMENT ENERGY UNITED STATES DEPARTMENT ENERGY WARNER LAMBERT CO US INDUSTRIAL CHEMICALS CO DIV NATL DISTILLERS & CHEM CORP MALLINCKRODT MEDICAL INC FOOD AND DRUG RES LABS INC BIOCONTACTS INC BIOCONTACTS INC COOPER LABORATORIES INC SCHERING AG DR REDDYS LABORATORIES LTD NATL PATENT DEVELOPMENT CORP AE STALEY CO BAYER SCHERING PHARMA AG ORTHO PHARMACEUTICAL CORP PFIZER INC GANES CHEMICALS INC ALZA CORP BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO ER SQUIBB AND SONS INC LINSON LTD EDWARD MENDELL CO INC NAPP CHEMICALS INC SCHERING AG REXAM HEALTHCARE PACKAGING INC MANUFACTURING FACILITY (PUERTO RICO PLANT) 1-ALPHA ACETYLMETHADOL (LAAM) SILVER SULFADIAZINE PRODUCTION METHODS, FACILITIES AND CONTROLS PRESS-SEAL SAFETY CLOSURES GENERAL OPERATING PROCEDURES PHENYLBUTAZONE (BULK) PROPOXYPHENE HYDROCHLORIDE ARCOPRIME 90 MOLYBDENUM-99-P-5 (DFORMERLY HELD BY UNION CARBIDE CORP) MOLYBDENUM-99-P-6 (DFORMERLY HELD BY UNION CARBIDE CORP) FACILITIES, CONTROL, PACKAGING VINYL ACETATE MONOMER MOLYDENUM 99:TECHNETIUM-99M PERSONNEL SCIENTIFIC & MANAGEMENT ORGANIZATION CHEM-101 BIO-139, POLYBUTON SOLUTION SILISOL OR TRILISOL TM NORETHISTERONE ENANTHATE NAPROXEN HYDRON BIOMEDICAL POLYMER TYPE A-1 ISOSWEET (HIGH FRUCTOSE CORN SYRUP) NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) MANUFACTURING, PACKAGING AND CONTROL TRIAMCINOLONE SODIUM THIOPENTAL INJ MANUFACTURE FACILITIES AND CONTROLS CARMUSTINE (BCNU) BULK & CARMUSTINE (BCNU) FOR INJ DROCINONIDE PHOSPHATE POTASSIUM DROCINONIDE PHOSPHATE POTASSIUM (BULK) (FARINEX 100M), FARINEX PROPOXYPHENE HCL CYPROTERONE ACETATE PACKAGING MATERIALS

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4Q2012EXCEL DMF# 2045 2046 2047 2048 2049 2050 2051 2052 2053 2054 2055 2056 2057 2058 2059 2060 2061 2062 I 2063 2064 2065 2066 2067 2068 2069 2070 2071 2072 2073 2074 2075 2076 2077 2078 2079 2080 I 2081 2082 2083 N I I II 3/9/1973 3/8/1973 A A I I I I I I I I I I I I I I I II IV II I IV III II II II III 1/15/1973 11/6/1972 1/30/1973 2/1/1973 1/15/1973 1/29/1973 12/6/1972 12/5/1972 1/31/1973 2/21/1973 2/23/1973 2/14/1973 2/21/1973 3/1/1973 3/5/1973 3/2/1973 2/9/1973 3/8/1973 STATUS Type SUBMIT DATE A I N I I N I A I I I I I A I I A III III II II II III I 1/26/1973 2/8/1973 2/7/1973 1/8/1973 1/30/1973 2/15/1973 2/13/1973 2/14/1973 1/12/1973 1/11/1973 1/9/1973 1/18/1973 II 2/8/1973 2/8/1973 III II 2/7/1975 2/8/1973 HOLDER AMCOR FLEXIBLES INC SCHERING AG NOT AN ASSIGNED NUMBER PFANSTIEHL LABORATORIES INC IMPERIAL CHEMICAL INDUSTRIES PLC NOT AN ASSIGNED NUMBER 3M REXAM HEALTHCARE PACKAGING INC LONZA INC RHODIA INC MCGAW INC UNIV OF WISCONSIN SCHERING AG WATSON STANDARD CO ALCOLAC INC SOGO PHARMACEUTICAL COMPANY LTD STYROLUTION AMERICA LLC KEY PHARMACEUTICALS INC SUB SCHERING PLOUGH CORP PALL CORP LUBRIZOL ADVANCED MATERIALS INC PROJECTS DEVELOPMENT CORP MCCLURE ROBERT E MR SYNTEX USA INC ORMA ISTITUDO TERAPEUTICO VIKING CHEMICAL CO HOOKER CHEM CORP ASHLAND CHEM CO DIV ASHLAND OIL INC CYCLO CHEM DIV TRAVENOL LABS INC G&W LABORATORIES INC MIL PAK INC WEST CO INDUSTRIA FARMACEUTICA SERONO SCHERING AG KNOLL PHARMA CHEMICALS COSDEN CHEM COATING CORP ONYX CHEM CO DIV MILLMASTER ONYX CORP NOT AN ASSIGNED NUMBER LINSON LTD GYMA LABORATORIES OF AMERICA INC C8F17BR PACKAGING COMPONENTS CREATINE SONYL NOVUM UNIT (PLASTIC BOTTLE) SUBJECT PHARMACEUTICAL TABLET PACKAGING MATERIAL NORETHISTERONE

4Q2012

FACILS & PERSONNEL (DFORMERLY HELD BY CYCLO CHEM DIV TRAVENOL INC) PIPOTHIAZINE PALMITATE SORBITOL IN PERITONEAL DIALYSIS SOL. SYNTHETIC VITAMIN D ANALOG CLOCORTOLINE TRIMETHYL ACETATE TUBE COATINGS SIPON (MLS) MAGNESIUM LAURYL SULFATE MANUFACTURE OF SULFISOXAZOLE POLYSAR LUSTREX HIGH TEST 88-5 & 92 POLYSTYRENE PLASTIC REPACKING MEPROBAMATE FILTER CARTRIDGE ESTANE 5701 MANUFACTURING FACILITIES; OF INVERN DELLA BEFFA ULTRASONIC DEVICE OLEIC DIETHANOLAMIDE, RS-6648 NORTHINDRONE VIKOFLEX 7190 RUCON B-341 8-HYDROXYQUINOLINE L-PROLYL-L-LEUCYLGLYCINE AMIDE MANUFACTURING FACILITIES AND CONTROLS DESC. OF FACILITIES FOR PACKAGING PHARMACEUTICALS,LYNDHURST, N.J. FACILITIES & PROCEDURES OF PLASTICS DIV. FOR WYETH IV ADDITIVE DEVICE FACILS. & CONTROLS OF ISTITUTO FARMCOLOGICO SERONO,ROME, ITALY MESTEROLONE (SH723) IBUPROFEN MANUFACTURED IN NOTTINGHAM, ENGLAND. TRANSPARENT COATING #82-9096A AMMONYX LO

HYDROFLUMETHIAZIDE HYDROQUINIDINE ALGINATE

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4Q2012EXCEL DMF# 2084 2085 2086 2087 2088 2089 I 2090 2091 2092 2093 2094 2095 2096 I 2097 2098 2099 2100 2101 2102 2103 2104 2105 2106 2107 2108 2109 2110 2111 2112 2113 2114 2115 2116 2117 2118 2119 2120 2121 2122 I I I I I I I I I I I I I I I I I I C I I I I I I I IV I II I II II II I II II II III II II 4/25/1973 4/27/1973 4/27/1973 5/2/1973 5/4/1973 5/14/1973 5/16/1973 5/16/1973 5/16/1973 5/17/1973 5/21/1973 5/31/1973 6/5/1973 6/7/1973 6/7/1973 6/13/1973 6/13/1973 6/15/1973 6/14/1973 6/21/1973 6/19/1973 6/25/1973 6/25/1973 6/20/1973 6/25/1973 6/27/1973 I I I I N N 4/17/1973 II IV 3/30/1973 4/2/1973 4/5/1973 4/6/1973 SYNTEX USA INC ALLERGAN PHARMACEUTICAL KORONIS AG DELMAR CHEMS LTD NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER ADAMHA NIMH CTR FOR STUDIES NARCOTIC NALTREX HCL AMP & DRUG ABUSE GANES CHEMICALS INC PHENDIMETRAZINE BITARTRATE BULK PHARMACIA AND UPJOHN SPA FARMITALIA HOECHST CELANESE CORP WILTEX MANUFACTURING CORP WORTHINGTON BIOCHEM CORP PHENCHEM INDUSTRIES LTD PHENCHEM INDUSTRIES LTD EURAND INTERNATIONAL SPA EURAND INTERNATIONAL SPA ARMOUR PHARMACEUTICAL CO PACKAGING CORP AMERICA CREST FOAM CORP ORGANON INC ORGANON INC INMONT CORP LILLY RES LABS DIV ELI LILLY CO BEECHAM SA TEVA PHARMACEUTICAL INDUSTRIES LTD HOFFMANN LA ROCHE INC GLIDDEN DURKEE PCR INC DELMAR CHEMS LTD MONSANTO COMPANY UNION CARBIDE CORPORATION NUCLEPORE CORP ADRIAMYCIN HCL BULK ADRIAMYCIN HCL INJ 10MG VIAL 5, 7-DICHLORO-8-HYDROXYQUINOLINE VIRGIN POLYESTER FIBER SANI-COIL ONTOSEIN, HUMAN GRADE ORGOTEIN STATUS Type SUBMIT DATE I I I I I III II III 2/27/1973 3/13/1973 3/20/1973 10/26/1972 4/9/1973 3/27/1973 HOLDER NAPP CHEMICALS INC BROWN BRIDGE DIV KIMBERLY CLARK EI DUPONT DE NEMOURS AND CO PROTOTYPE PACKAGING INC IMCO CONTAINER CO MALLINCKRODT INC SUBJECT SODIUM SULFACETAMIDE USP XX HEAT SEALEABLE LABELS 400BL, 420BL, 63BAK ELVAX 40 BLOW MOLDED PLASTIC CONTAINERS PLASTIC BOTTLES MANUFACTURING & CONTROLS FOR LEVO ALPHA METHADYL ACETATE HYDROCHLORIDE RS-7068

4Q2012

GSH-1157-1738 ENZYME--CLEANING FORMULATION FOR POLYHEMA SOFT LENSES PSORIASIS VULGARIS (DISEASE) ANTI-PSORIAICUM PHENDIMETRAZINE BITARTRATE (BULK POWDER)

CHLORDIAZEPOXIDE HCL USP (DFORMERLY HELD BY MICRO CHEMICALS LTD) CHLORPROMAZINE HYDROCHLORIDE MICROENCAPSULATIONPROCEDURE MICROENCAPSULATION PROPOXYPHENE HCL TAUROCHOLIC ACID PHYSICAL FACILITIES CRESTHANE 3310, 3615 NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) ESTERIFIED ESTROGENS U.S.P. FORMULA M76LC002, C294-23 GOLD ENAMEL; 83 GOLD ENAMEL; 13782 GOL ENA COLCHICINE TABLETS GENERAL OPERATING PROCEDURES FOR THE HEPPIGIES, BELGIUM--ANTIBIOTICS HYDROCHLOROTHIAZIDE AND CHLOROTHIAZIDE B-AMINOPROPIONITRILE FUMARATE SILCRONS FACILITIES AND CONTROL IMIPRAMINE HYDROCHLORIDE SANTICIZER 334 F BAKELITE BRAND VINYLRESIN QYNA NUCLEPORE MEMBRANE

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4Q2012EXCEL DMF# 2123 2124 2125 2126 I 2127 2128 2129 2130 2131 2132 2133 2134 I 2135 2136 2137 2138 2139 2140 A 2141 2142 2143 2144 2145 2146 2147 2148 2149 2150 2151 2152 2153 2154 2155 2156 2157 2158 2159 2160 2161 I I I I I I I N I I A I I I I I I I I I I II II II II II IV 8/21/1973 9/4/1973 9/6/1973 9/7/1973 9/10/1973 9/10/1973 9/12/1973 9/28/1973 10/1/1973 10/2/1973 10/2/1973 10/10/1973 10/10/1973 III II IV 8/8/1973 8/21/1973 8/21/1973 8/18/1973 8/6/1973 8/20/1973 8/27/1973 I I I I I I II II III II 7/30/1973 7/30/1973 10/3/1972 8/1/1973 8/13/1973 8/7/1973 GYMA LABORATORIES OF AMERICA INC ARMSTRONG PRODUCTS CO RACHELLE LABORATORIES INC BIOQUEST COOPER LABORATORIES INC FIDIA FARMACEUTICI SPA DIVISIONE SOLMAG RP SCHERER HARD CAPSULE INC GYMA LABORATORIES OF AMERICA INC GYMA LABORATORIES OF AMERICA INC GYMA LABORATORIES OF AMERICA INC PERFUMERY ASSOCIATES INC THATCHER GLASS MANUFACTURING CO SCHWARTZ MANN NOT AN ASSIGNED NUMBER NAPP CHEMICALS INC UPJOHN CO SHIN ETSU CHEMICAL CO LTD HAZELTON LABS INC WHEATON PLASTIC CONTAINERS KV PHARMACEUTICAL CO RHODIA INC LEPETIT LABS SA WEDDEL PHARMS LTD CALBIOCHEM-BEHRING CORP WARNER LAMBERT CO EDWARD F PRODIGO ENTERPRISES INC AYERST LABORATORIES INC SULFAMETHAZINE USP. BETAMETHASONE, 17-BENZOATE HPMCP(HYPROMELLOSE PHTHALATE) FACILITIES, EQUIPMENT, PERSONNEL S-1980F1 4OZ BOSTON ROUND AEROSOL BOTTLE PSEUDOEPHEDRINE HCL 120MG S.R. CAPS. CERUBIDINE LEVODOPA (BULK) CHENODEOXYCHOLIC ACID (CHENDOL) CB-351 CAPS MANUFACTURING FACILITY LITITZ, PA FACILITIES, METHODS AND CONTROL FOR PACKAGING PRIMIDONE CAP I I I I I I I III II II I II 8/7/1973 7/11/1973 7/13/1973 7/13/1973 7/6/1973 7/23/1973 7/23/1973 8/1/1973 STATUS Type SUBMIT DATE I I I IV III II 6/25/1973 6/25/1973 6/28/1973 7/11/1973 HOLDER MONSANTO COMPANY NORDA INC GRAHAM PACKAGING COMPANY L.P. BECKMAN INSTRUMENTS INC DIV SMITHKLINE BECKMAN CORPORATION ROHM AND HAAS CO LILLY RES LABS DIV ELI LILLY CO ICI AMERICAS INC KV PHARMACEUTICAL CO ALUMINUM COMPANY OF AMERICA ACETO CHEMICAL CO INC GANES CHEMICALS INC MOUNT SINAI MEDCTR SUBJECT ROSAFIX FRAGRANCE FORMULA ONLY NORDA PERFUME OIL BOUQUET #6061 PLASTIC PRODUCTS

4Q2012

SYNTHETIC LUTEINIZING HORMONE-RELEASING HORMONE (PORCINE, OVIVE) HYAMINE 1622 CRYSTALS (BENSETHONIUM CHLORIDE) 7-AMINO CEPHALOSPORANIC ACID BRIJ 76 PILOT PARENTERAL MANUFAC FACILITY, HANLEY INDUSTRIAL COURT ALCOA PVC 103, ALCOA PVC 115 OXYPHENBUTAZONR BULK PROCAINAMIDE HYDROCHLORIDE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. CHLORPROMAZINE HYDROCHLORIDE 392 GLD POWDER SIDE STRIPE IDOXURIDINE TEST DISCS (TRIMETHOPRIM PLUS SULFAMETHOXAZOLE) BOIL N SOAK (TM) PLIASOL PHENDIMETRAZINE TARTRATE EMPTY HARD GELATIN CAPSULES DIETHYLPROPIONE HCL CHLORPHENTERMINE HCL PHENTERMINE HCL MADE IN ITALY ORANGE NATURAL EXTRACT #25 (TAMARIND FANTAISIE) SC 100 COLD END GLASS COATING; SC 300 SYNTHETIC BIOLOGICALLY-ACTIVE BRADYKININ

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4Q2012EXCEL DMF# 2162 2163 2164 2165 2166 2167 2168 2169 2170 2171 2172 2173 2174 2175 2176 2177 2178 I 2179 I 2180 2181 I 2182 2183 2184 2185 2186 I 2187 2188 2189 2190 2191 2192 2193 2194 2195 2196 2197 2198 2199 I I I I I I A I A A I A A II II II II II II I III 11/12/1973 10/29/1973 11/16/1973 11/7/1973 11/20/1973 11/21/1973 11/20/1973 11/27/1973 11/27/1973 11/27/1973 11/29/1973 12/3/1973 12/7/1973 I I I I II II V 1/2/1973 11/12/1973 10/9/1973 10/17/1972 11/15/1973 I 10/15/1973 1/2/1973 10/30/1973 LAFAYETTE PHARMACAL DIV ALCON LABORATORIES INC RHODIA INC SCHWARZ MANN DIV BECTON DICKINSON AND CO TRAVENOL LABORATORIES INC CELANESE COATINGS CO PFANSTIEHL LABORATORIES INC ANTIBIOTICOS SPA COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARL AYERST LABORATORIES INC COLLETT MARWELL HAUGE A/S KV PHARMACEUTICAL CO CELANESE PLASTICS COOPER LABORATORIES INC ER SQUIBB AND SONS INC SIFAVITOR SRL SARGENT INDUSTRIES ROUSSEL-UCLAF INDUSTRIA CHIMICA MILANESE SPA ICN PHARMACEUTICAL INC LILLY RES LABS DIV ELI LILLY CO SIEGFRIED LTD MANUFACTURING OPERATIONS FORMULAS: RHODIAL & BOUQUET 5886 PRODUCT 90-1431,90-1432 SYTHETIC SECRETIN STABILITY & COMPAIBILITY OF DRUG ADDITIVES INTRO INT INJ # 86 GOLD HS CAN LINING L-ARGININE MONOHYDROCHLORIDE HYDROCORTISONE 17-VALERATE METRONIDAZOLE AY-22,284 ANALDOSE REDUCTASE INHIBITOR PROCAINAMIDE S.R. TAB 300 & 500MGS MANUFACTURING FACILITIES AND CONTROLS CELCON REN-O-GEL (TM) I AND II KIT PLASTIC CONTAINERS TRICHLORMETHIAZIDE NF XIII NITRILE COMPOUND SR 3013-70 HEMATOPORPHYRIN HCL DEXTRO-PROPOXYPHENE HCL MFG. FACILITIES AND CONTROLS FOR ICN PLAINT, AQUADILLA, PUERTO RICO ERYTHROMYCIN ESTOLATE PRIMIDONE USP XVIIII STATUS Type SUBMIT DATE I I I I I I I I I I I I I I I I II II III I II II II 10/4/1973 10/4/1973 10/9/1973 10/2/1973 10/16/1973 10/17/1973 10/10/1973 10/24/1973 10/24/1973 10/24/1973 10/19/1973 10/5/1973 10/5/1973 10/10/1973 10/30/1973 10/3/1973 10/26/1973 HOLDER HOFFMANN LA ROCHE INC DELMAR CHEMS LTD CONTINENTAL CAN COMPANY CHEVRON PHILLIPS CHEMICAL CO.,LP. PROQUINA SA HOECHST MARION ROUSSEL INC REXHAM CORP KYOWA HAKKO USA INC KYOWA HAKKO KOGYO CO LTD PFIZER INC BEL MAR LABORATORIES INC ROBINSON BROTHERS LTD UNION CARBIDE CORPORATION ETHYL CORP AMERICAN CAN GEORGE ANGUS & CO LTD TELEDYNE WIRZ SUBJECT R03-0749/607 DISODIUM PYRIDOXAL PHOSPHATE INJ PHENAZOPYRIDINE HYDROCHLORIDE (BULK POWDER) 142 CLS ENAMEL PLASTIC BOTTLES PRODUCED BY AN INJECTION BLOW MOLDING PROCESS GENERAL OPERATING PROCEDURE PROBUCOL (DH-581) INK AND COLOR FORMULATIONS MANUFACTURING FACILITIES & CONTROLS (BULK DRUGS) L-ARGININE, L-ARGININE MONOHYDROCHLORIDE L-LYSINE MONOHYDROCHLORIDE STANDARD OPERATING PROCEDURE PIPERIDINE HYDROCHLORIDE BAKELITE BRAND VINYL CHLORIDE-ACETATE COPOLYMER, VYNW5 & VYNW 6 ETHYL 9110 POLUVINYL CHLORIDE COMPOUND WAX LINED ALUMINUM TUBE COMPOUND KL 1104

4Q2012

MATERIALS USED/POLYETHYLENE BOTTLES MADE BY EXTRUSION BLOW MOLD METHOD

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4Q2012EXCEL DMF# 2200 A 2201 2202 2203 2204 2205 2206 2207 2208 2209 2210 2211 2212 2213 2214 2215 2216 2217 2218 2219 2220 I 2221 2222 I 2223 2224 2225 I 2226 2227 2228 2229 A 2230 2231 2232 2233 I 2234 I 2235 I 2/26/1974 II 2/20/1974 I I I 2/4/1974 8/17/1973 2/20/1974 2/21/1974 ANDRE GUERBET LABS KV PHARMACEUTICAL CO FIRMENICH INC BEECHAM-MASSENGILL PHARMS DIV BEECHAM INC SCHWARZ MANN DIV BECTON DICKINSON AND CO PECHET MAURIC M MD I N N III 2/5/1974 1/31/1974 I I II 1/18/1974 1/28/1974 2/1/1974 I I 1/17/1974 1/17/1974 I I I A I I I I I I I I I I I I I I I IV I II II I II II II II II II II 12/13/1973 12/20/1973 12/21/1973 12/31/1973 12/31/1973 12/31/1973 12/31/1973 12/18/1973 1/4/1974 12/19/1973 1/8/1974 12/11/1973 1/16/1974 1/22/1974 1/21/1974 1/22/1974 1/23/1974 1/25/1974 1/23/1974 1/29/1974 STATUS Type SUBMIT DATE II 12/12/1973 HOLDER SOCIETA ITALIANA MEDICINALI SCANDICCI (SIMS) ER SQUIBB AND SONS INC BRACCO IND CHIMICA SPA BRISTOL MYERS SQUIBB CO ANTIBIOTICOS SPA ANTIBIOTICOS SPA ANTIBIOTICOS SPA ANTIBIOTICOS SPA CYCLO CHEM DIV TRAVENOL LABS INC ORGANON INC ALUMINUM COMPANY OF AMERICA SOLVAY PHARMACEUTICALS 3-M NUCLEAR PRODUCTS HOECHST MARION ROUSSEL SA ICN CANADA LTD SYNTEX USA INC VERNAY LABORATORIES INC ORGANICHEM CORP GYMA LABORATORIES OF AMERICA INC ICN PHARMACEUTICALS INC KALSEC KALAMAZOO SPICE EXTRACTION CO PHARMACIA AND UPJOHN INC SUBJECT CHLORDIAZE POXIDE & CHLORDIAZE POXIDE (BULK) COMPOUND SQ 21, 286 IODOXAMIC ACID (BULK) HALCINONIDE BULK, MANUFACTURED IN HUMACAO, PUERTO RICO NON-STERILE BETAMETHASONE (BULK) DEXAMETHASONE, NON-STERILE (BULK) TRIAMCINOLONE TRIAMCINOLONE DIACETATE PHENDIMETRAZINE TARTRATE TUBOCURARINE CHLORIDE PILFERPROOF CLOSURE (18MM) QUALITY CONTROL MANUAL MICROSPHERES TRIENE PLANT MASTER FILE SODIUM 7-ISOPROPOXYANTHONE-2-CARBOXYLATE (RS-6818) STOPPERS GENERAL DESCRIPTION OF PLANT SULFAMETHAZINE MANUFACTURING FACILITIES & CONTROLS SPICES AND SPICE EXTRACTIONS ANTIBIOTIC GENERAL INFORMATION

4Q2012

AYERST LABORATORIES INC DIV AMERICAN QUILENE HOME PRODUCTS CORP GLOGAU AND CO INC MANUFACTURE PROCEDURES ADAMHA NIDA METHADONE AYERST LABORATORIES INC DIV AMERICAN 6-AM (6-DEOXY-6-AZIDIDIHYDROMORPHINE BITARTRATE) AMP. HOME PRODUCTS CORP EASTMAN KODAK CO 1-CHLORO-2, 4-DINITROBENZENE NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER REXAM CLOSURE SYSTEMS INC CLIC-LOC CHILD AND FINAL GENERATION (FG) CHILD RESISTANT CLOSURES MANUFACTURED AT BROOKVILLE, PA IOCARMIC ACID PSEUDOEPHEDRINE HCL & CHLORPHENIRAMINE MALEATE S.R.C. CHEMODERM 840 & 985 RAW MATERIALS SPECIFICATIONS BRADYKININ POTENTIAING FACTOR-NONAPEPTIDE 1A-HYDROXY VITAMIN D3

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4Q2012EXCEL DMF# 2236 2237 2238 2239 2240 2241 2242 2243 2244 2245 2246 I 2247 2248 2249 2250 2251 2252 2253 2254 I 2255 2256 2257 2258 2259 2260 2261 2262 2263 2264 2265 2266 2267 2268 2269 2270 2271 I 2272 2273 2274 I I I 5/13/1974 5/10/1974 5/8/1974 I A I I I I I I I I I I I I A I II V II III II III II I II II III 3/14/1974 4/2/1974 4/8/1974 4/9/1974 4/11/1974 4/7/1974 4/10/1974 3/28/1974 4/24/1974 4/17/1974 4/25/1974 4/19/1974 5/1/1974 4/30/1974 4/26/1974 4/30/1974 5/1/1974 DOW CHEMICAL CO MICHIGAN DIV KERR GROUP SUB BERRY PLASTICS CORP PFW INC FERMENTA FRANCE SA SQUIBB MARVI SA CALBIOCHEM-BEHRING CORP LABORATORIO ELEA SACIFYA SYNTEX USA INC BASF CORPORATION AYERST LABORATORIES INC ISOMEDIX INC CAMBRIDGE NUCLEAR CORP SOLVAY PHARMACEUTICALS STERIS-ISOMEDIX SERVICES H REISMAN CORP I A I I I I I II I II II III I II 3/12/1974 3/21/1974 3/22/1974 3/28/1974 3/18/1974 3/14/1974 3/28/1974 3/27/1974 STATUS Type SUBMIT DATE I A I A I I I I I I II III II II 2/27/1974 3/1/1974 3/1/1974 3/1/1974 12/14/1973 2/26/1974 2/26/1974 2/22/1974 3/14/1974 3/4/1974 3/5/1974 HOLDER KV PHARMACEUTICAL CO AMCOR FLEXIBLES SHELBYVILLE BOFORS INDS CAMBREX CHARLES CITY INC CYCLO PRODUCTS INC P-L BIOCHEMS INC P-L BIOCHEMS INC TROPONWERKE GMBH CO KG BRACCO IND CHIMICA SPA DOW CORNING CORP BEECHAM-MASSENGILL PHARMS DIV BEECHAM INC KYOWA HAKKO KOGYO CO LTD CAMBREX PROFARMACO MILANO SRL MYLAN TECHNOLOGIES INC CARTRIX PARENTERAL SYSTEMS ORGANON INC JOHNSON & JOHNSON PRODUCTS INC RP SCHERER CORP RHONE POULENC LTD SUBJECT FACILITIES, CONTROL, PERSONNEL PACKAGING LAMINATES ISOSORBIDE DINITRATE SALICYLAZOSUSULFAPYRIDINE, MANUFACTURED IN CHARLES CITY, IOWA N-DECYLMETHYL SULFOXIDE POLYADENYLIC ACID POLYURIDYLIC ACID BUFENOID COMPOUND IOPRONIC ACID DOW CORNING X-95704 ANTIMICROBIAL 6-AMINO PENICILLANIC ACID L-TRYPTOPHAN, L-TYROSINE, L-ASPARTIC ACID (L-PROLINE, L-GLUTAMIC) BISACODYL PLASTIC BOTTLES

4Q2012

MANUFACTURE OF PARENTERAL PRODUCTS (FACILITIES, CONTROLS PERSONNEL) NORANDROS TENEDIONE (NANDROLONE) POLYETHYLENE CONTAINERS DIGOXIN CAPS FACILITIES, PERSONNEL & PROCEDURES FOR PHARMACEUTICAL FINISHED PRODUCT PRODUCTION IN DAGENHAM, ENGLAND. PZ 5561.21 (DURAFILM PRODUCT) CR-I CHILD-RESISTANT CLOSURES MENTHYL ANTHRANILATE 263610,260160 HYDROXYUREA BY OLMACO OF EMPERNON,FRANCE (FORMERLY HELD BY OLMACO) HYDROXYUREA MANUFACTURE OF GLASS AMPULS, VIALS 4-EPI-TETRACYCLINE HYDROCHLORIDE HUMAN CHORIONIC GONADOTROPHIN RS 8584 POLYSTYRENE PLASTICS DEXPROPRANOLOL INJ RADIATION PROCESSING OF DRUGS CALCIUM CHLORIDE CA-45, CA-47 CHENODEOXYCHOLIC ACID CONTRACT STERILIZATION FACILITY IN MORTON GROVE,IL CHLORPROMAZINE HYDROCHLORIDE (BULK)

ABBOTT LABORATORIES PHARMACEUTICAL SEMI-RIGID CONTAINER PLASTIC BOTTLE PRODUCTS DIV AYERST LABORATORIES INC GRISACTIN CELLO FOIL PRODUCTS INC WILLIAM FREEMAN & COMPANY LTD STRUCTURED PACKAGING MATERIALS RUBBER COMPOUND 161063

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4Q2012EXCEL DMF# 2275 2276 2277 2278 2279 2280 2281 2282 2283 I 2284 2285 2286 2287 2288 2289 2290 2291 2292 2293 2294 2295 2296 2297 2298 2299 2300 2301 2302 2303 2304 2305 2306 2307 2308 2309 2310 2311 2312 2313 2314 I I I I I I I I I I I I I A I I I I I A I I I I I I I I I I A II II I II II II II III II V II II II II II III II II III III 6/3/1974 6/3/1974 6/11/1974 6/12/1974 6/14/1974 6/12/1984 6/12/1984 6/18/1974 6/19/1974 6/21/1974 6/24/1974 5/30/1974 8/23/1973 6/14/1974 7/1/1974 7/3/1974 7/5/1974 7/11/1974 7/11/1974 7/11/1974 7/16/1974 7/17/1974 1/16/1974 7/22/1974 7/30/1974 3/15/1974 7/30/1974 8/6/1974 8/8/1974 8/6/1974 8/8/1974 STATUS Type SUBMIT DATE I I A I I I I I II II II III 5/2/1974 5/15/1974 5/17/1974 5/23/1974 5/23/1974 5/31/1974 5/31/1974 5/30/1974 5/28/1974 HOLDER IMCO CONTAINER CO DELMAR CHEMS LTD ROCHE DIAGNOSTICS GMBH KV PHARMACEUTICAL CO NAPP CHEMICALS INC DELMAR CHEMS LTD UNION CARBIDE CORPORATION PCR INC BECKMAN INSTRUMENTS INC DIV SMITHKLINE BECKMAN CORPORATION SHEFFIELD TUBE CORP OCONNOR PACKAGING CO CAMBRIDGE NUCLEAR RADIOPHARM CORP ARMOUR PHARMACEUTICAL CO AMERICAN NATIONAL CAN CO UNION CARBIDE CORPORATION CAMBRIDGE NUCLEAR RADIOPHARM CORP ROUSSEL CORPORATION HOFFMANN LA ROCHE INC GANES CHEMICALS INC ETHYL CORP REEVES BROTHERS INC EMSON RESEARCH INC INTERNATIONAL SPECIALTY PRODUCTS KNOLL AG CHEMISCHE FABRIKEN KYOWA HAKKO KOGYO CO LTD BEECHAM PHARMACEUTICALS PTE LTD INDUSTRIAL REACTOR LABORATORIES INC GANES CHEMICALS INC FIDIA FARMACEUTICI SPA KYOWA HAKKO USA INC NATIONAL STARCH & CHEMICAL CORP SSL INTERNATIONAL CAMBRIDGE NUCLEAR RADIOPHARM CORP BRACCO IND CHIMICA SPA FERRING AB KV PHARMACEUTICAL CO TRAVENOL LABORATORIES INC SYNTEX PUERTO RICO INC PFIZER LABORATORIES DIV PFIZER INC BOEHRINGER INGELHEIM CHEMICALS INC SUBJECT CONTAINERS, CLOSURES AND FITMENTS KETAZOLAM, BULK POWDER DIGOXIN PRODUCTS CHLORPHENIRAMINE MALEATE 12 MG SRC MEGLUMINE SALICYLATE

4Q2012

D.M.M.P.(1,3-BISMETHOXYMETHYL-5-ETHYL-5-PHENYL-BARBITURIC ACID)BULK ZIRCONIA TEXTILES PROMAZINE HYDROCHLORIDE THYROTROPIN RELEASING HORMONE TUBE LINERS, TUBE CLOSURE SEALANTS AND CAP LINERS PACKAGING SODIUM CHLORIDE NA-24 DIPALMITOYL-DL-3-LECITHIN ALUMINUM FOIL-POLYPROPYLENE LAMINATE SYNTHETIC SODIUM ALUMINOSILICATE ABSORBENTS (MOLECULAR SIEVES) SODIUM BROMIDE BR82 ESTRADIOL BENZOATE PROCARBAZINE HYDROCHLORIDE PARENTERAL GLUTETHIMIDE BULK AS MANUF A PENNSVILLE, NJ TOLMETIN (MCN2559-21-98) COMPOUND #5165 RUBBER GASKET MATERIAL DISPENSING DEVICES POLYVINYLPOLYPYRROLIDONE (CROSPOVIDONE) DIHYDROXYPROPYL-THEOPHYLLIN FACILITIES & CONTROLS (UBE PLANT IN JAPAN) GENERAL OPERATING PROCEDURES SINGAPORE PLANT RADIOCHEMICAL 99 MOO 3 DIPYRONE DICYCLOMINE HYDROCHLORIDE L-VALINE, L-THREONINE, L-GLUTAMINE ADHESIVES E 56620 & 56635 (FORMERLY CODED 4620 & 4635) TOXICOLOGY STUDIES ON CHLORHEXIDINE GLUCONATE SODIUM SULFATE S-35 DIARIZOIC ACID DESURIN, MINRIN, DDAVP METHYLTESTOSTERONE PROTEIN HYDROLYSATE BULK POWDER FOR PARENTERAL SOLUTIONS FACILITIES AND CONTROLS ANTIBIOTIC SUSCEPTIBILITY DISCS AMPHETAMINE BULK AND DEXTRO DESOXYEPHEDRINE (ESUB)

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4Q2012EXCEL DMF# 2315 2316 2317 I 2318 A 2319 2320 2321 2322 2323 2324 2325 2326 2327 2328 2329 2330 2331 2332 2333 2334 2335 2336 2337 2338 2339 2340 2341 I 2342 2343 2344 2345 2346 2347 2348 2349 2350 2351 2352 I I A I I I I I I I I II II II II III 10/17/1974 10/28/1974 10/17/1974 10/29/1974 10/24/1974 10/31/1974 11/1/1974 11/4/1974 9/17/1974 11/11/1974 11/12/1974 I I I N N I I I I I I I I I I N I I I I I I III III IV 10/16/1974 10/24/1974 10/7/1974 10/3/1973 7/30/1974 9/10/1974 9/4/1974 V III II III 9/6/1974 9/10/1974 8/21/1974 9/18/1974 9/20/1974 9/26/1974 9/25/1974 10/7/1974 10/10/1974 10/9/1974 II 8/26/1974 8/27/1974 8/26/1974 ORTHO PHARMACEUTICALS INC SWORDS LABORATORIES LTD GANES CHEMICALS INC NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER BURTON,PARSONS & COMPANY,INC. OHIO MEDICAL PRODUCTS DIV AIRCO INC FLINT HILLS RESOURCES LP GAF CORPORATION CHEMICAL DIV TRAVENOL LABORATORIES INC HOECHST CELANESE CORP UNIV MICHIGAN MEDCTR WIMMER KG MERRELL-NATIONAL LABORATORIES INC UPJOHN CO NOT AN ASSIGNED NUMBER BARNES HIND PHARMACEUTICALS INC ALCON LABORATORIES INC REXENE CORP GLYCO CHEMICALS INC DIAMOND SHAMROCK CORP DIAMOND SHAMROCK CORP DEWEY AND ALMY CHEM DIV WR GRACE AND CO SIGMA F AND D DIV LTD INEOS BAREX KV PHARMACEUTICAL CO DOW CORNING CORP BURTON,PARSONS & COMPANY,INC. BARNES HIND PHARMACEUTICALS INC HOECHST AG DENVER CHEM MFG CO UNITED STATES DEPARTMENT ENERGY SIGMA F AND D DIV LTD PIERCE & STEVENS CHEMICAL CORPORATION BARNES-HIND BOILING SOLUTION BURTON PARSONS BUTTON FOR HYDROPILIC SOFT CONTACT LENSES ETHRANE (ENFLURANE) FORANE (ISOFLURANE) POLYETHYLENE RESINS FLUOROL 7GA LARGE VOLUME PARENTERAL PRODUCTS - PYROGEN TESTING PACKAGING O-IODOBENZYLTRIMETHYL AMMONIUM IODIDE RUBBER STOPPERS A-40 GREY FOR INFUSION BOTTLES FACILITIES AND CONTROLS PELLETHANE MDI BASED URETHANE ELASTOMER DESCRIPTION , BLDG, EQUIP., KEY PERSONNEL FLUPHENAZINE ENANTHATE N.F. PROPANTHELINE BROMIDE II 8/23/1974 STATUS Type SUBMIT DATE A I V I 7/26/1974 8/16/1974 8/19/1984 HOLDER BEN VENUE LABORATORIES INC MALLINCKRODT INC USV PHARMACEUTICAL CORP SUB RORER GROUP TAKEDA PHARMACEUTICAL COMPANY LTD. SUBJECT STERILE PROCESSING FACILITY (ESUB) IN BEDFORD, OHIO MANUFACTURING FACILITY AT RALEIGH, NORTH CAROLINA MANUFACTURE, PACKAGING AND DISTRIBUTION FOLIC ACID

4Q2012

STEROID/ANTI-INFECTIVE OPHTH.COMBINATIONS;SAFETY/EFFICACY ANALYSIS POLYPROPYLENE PLASTICS 14B AND 14S SERIES ACRAWAX C FOAMASTER VF NOPCOWAX 22 DS MICRO DAREX CAP COMPOUND 64 L-TRYPTOPHAN BAREX 210 RESIN LEVODOPA S.R.C. 300MG DOW CORNING F-218 FLUID SOACLENS (SILICO) CONTACT LENS SOLUTION SOFT CONTACT LENS CLEANER FOR USE WITH FLEXLENS (TRANSF. TO DEVICES) HALOTHANE MANUFACTURING FACILITIES AND CONTROLS RADIOISOTOPE MOLYBDENUM-99-P-7 (FORMERLY HELD BY UNION CARBIDE CORP) 6,9-DIAMINO-2-ETHOXYACRIDINE LACTATE FOAMCOAT (TM) A7673A

Page 64

4Q2012EXCEL DMF# 2353 2354 2355 2356 I 2357 2358 2359 I 2360 2361 I 2362 2363 2364 2365 2366 2367 2368 2369 2370 2371 2372 2373 2374 2375 2376 2377 2378 2379 2380 2381 2382 2383 2384 2385 2386 2387 2388 I 2389 2390 I I I I 1/10/1975 1/14/1975 LILLY RES LABS DIV ELI LILLY CO ER SQUIBB AND SONS INC I I A I I I A N I I I I I I I I I I I I I I I I I I II II V II I II II II II II II II 12/3/1974 12/12/1974 12/16/1974 12/13/1974 12/18/1974 12/18/1974 12/18/1974 12/18/1974 12/18/1974 12/26/1974 12/20/1974 12/6/1974 12/31/1974 12/31/1974 1/3/1975 1/3/1975 1/3/1975 1/3/1975 1/7/1975 III II II II II 11/25/1974 11/27/1974 11/26/1974 12/20/1974 12/6/1974 12/6/1975 12/10/1974 I III 11/25/1974 11/29/1974 UNION CARBIDE CORPORATION I I II I 11/8/1974 11/18/1974 11/19/1974 STATUS Type SUBMIT DATE I I I II II II 11/18/1974 11/11/1974 11/19/1974 11/6/1974 HOLDER PFANSTIEHL LABORATORIES INC MALLINCKRODT CHEMICAL WORKS MALLINCKRODT INC SUBJECT SUCROSE MONOOLEATE CHLORZOXAZONE STEAR-O-WET C (CALCIUM STEARATE)

4Q2012

WAITAKI INTERNATIONAL BIOSCIENCES SUB CHENODEOXYCHOLIC ACID WAITAKI CANADA LTD CUTTER LABORATORIES INC CUTTER STABILITY DATA WARNER LAMBERT CO SCIENTIFIC ASSOC INC PLEXIGEL(POLYETHYLENE OINT. BASE) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. UDEL POLYSULFONE RESIN P-1700

ABBOTT LABORATORIES PHARMACEUTICAL QUALITY ASSURANCE OPERATION STANDARDS PRODUCTS DIV WESLEY-JESSEN INC DURASOFT (TM) AUTOCLAVE STERILIZER RENASA, INC. SUBSIDIARY OF E.R. SQUIBB SANOFI AVENTIS CHIMIE MERCK FROSST CANADA INC WACKER CHEMIE GMBH HB FULLER CO TRIFARMA SPA NOT AN ASSIGNED NUMBER FLOW PHARMS INC STUDSVIK ISOTOPSERVICE AB EI DUPONT DE NEMOURS AND CO HOFFMANN LA ROCHE INC ER SQUIBB AND SONS INC SIGMA F AND D DIV LTD ANTIBIOTICOS SPA ANTIBIOTICOS SPA ANTIBIOTICOS SPA ASTRA USA INC ALLERGAN PHARMACEUTICAL PFANSTIEHL LABORATORIES INC EI DUPONT DE NEMOURS AND CO EI DUPONT DE NEMOURS AND CO SIGMA F AND D DIV LTD CIECH POLFA CIECH POLFA CIECH POLFA STERIGENICS INTERNATIONAL PLIACIDE RADIOACTIVE XENON-133 GAS SODIUM-24 RADIOISOTOPE (FORMERLY NEW ENGLAND NUCLEAR) 1A,25-DIHYDROXYCHOLECALCIFEROL (RO21,5535) IN USAN IS CALCITRIOL FLUPHENAZINE DECANOATE INJ. DEOXYCHOLIC ACID PREDNISOLONE SODIUM PHOSPHATE BULK BETAMETHASONE SODIUM PHOSPHATE, N.F. XIII BULK DEXAMETHASONE SODIUM PHOSPHATE BULK FACILITIES AMD CONTROLS GSH-1157-2333X PROLASE 300 (SOFT CONTACT LENS CLEANER) A LACTULOSE MANUFACTURING FACILITIES AND CONTROL MANUFACTURING FACILITIES AND CONTROLS (FORMERLY NEW ENGLAND NUCLEAR) 2-DEOXY-D-GLUCOSE SULFAMERAZINE SULFAMETHAZINE SULFATHIAZOLE STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN ROCKAWAY, NJ PRODUCTION OPERATIONS PERSONNEL FOR PUERTO RICO PLANTS HALOG (HALCINONIDE) 0.1% CREAM MANUFACTURED IN HUMACAO, PUERTORICO. NORGESTERAL ACETATE OXIME TECHNETIUM TC 99M POLYPHOSPHATE KIT SILICONE RUBBER HL 44 FULLER'S HM-777-R INNER SEAL PROCHLORPERAZINE BASE,PROCHLORPERAZINE MALEATE

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4Q2012EXCEL DMF# 2391 2392 A 2393 2394 2395 2396 2397 2398 I 2399 2400 2401 2402 I 2403 2404 2405 2406 2407 2408 2409 2410 2411 2412 2413 2414 2415 2416 2417 2418 2419 2420 2421 2422 2423 2424 2425 2426 2427 2428 2429 I I I A I I I I I I I I I I A A I A A I I I I I I I I II II II II II II I III II II II III III II 2/26/1975 2/26/1975 2/21/1975 2/19/1975 2/20/1975 2/26/1975 1/21/1975 2/25/1975 3/5/1975 3/3/1975 3/10/1975 3/10/1975 3/7/1975 3/12/1975 1/13/1975 2/24/1975 3/28/1975 3/11/1975 3/14/1975 3/20/1975 3/27/1975 3/6/1975 3/27/1975 3/28/1975 3/19/1975 3/13/1975 3/18/1975 I I I II II III 2/11/1975 2/19/1975 2/19/1975 2/21/1975 I I I I I III II 1/28/1975 2/17/1975 1/29/1975 2/7/1975 2/7/1975 1/23/1975 STATUS Type SUBMIT DATE I I III 1/17/1975 1/16/1975 HOLDER SYNTEX RES DIV SYNTEX LABS INC EQUISTAR CHEMICALS LP SUB LYONDELLBASELL CALBIOCHEM CORP GENERAL ELECTRIC CORP DELMAR CHEMS LTD LEHIGH PACKAGING SYNTEX USA INC WEST INDIES PHARMACEUTICAL & COSMETICS INC ROUSSEL-UCLAF SYNTEX USA INC DUPONT TEIJIN FILMS US LP WINTHROP PHARMACEUTICALS DIV STERLING DRUG INC ER SQUIBB AND SONS INC TAYLOR PHARMACAL CO ELLIS PHARMACEUTICAL CONSULTING INC CHEVRON PHILLIPS CHEMICAL CO LP FLINT HILLS RESOURCES LP PARKE DAVIS & CO KV PHARMACEUTICAL CO BOEHRINGER MANNHEIM GMBH COLUMBIA RESEARCH CORP JANAR CO INC HOFFMANN LA ROCHE INC BARNES HIND PHARMACEUTICALS INC UNIV MICHIGAN MEDCTR CORD LABORATORIES INC SELIG SEALING PRODUCTS INC PHARMACIA AND UPJOHN SUB PFIZER INC KERR MANUFACTURING CO STARKS ASSOC INC SUMITOMO CHEMICAL CO LTD NORTH AMERICAN BIOLOGICALS INC NAPP CHEMICALS INC UNIROYAL CHEM DIV UNIROYAL INC ROUSSEL-UCLAF LILLY RES LABS DIV ELI LILLY CO HEINRICH MACK NACHF SIGMA F AND D DIV LTD GENERAL ELECTRIC CORP SUBJECT METHODS, FACILITIES AND CONTROLS PROFAX (R) PD 191 NATURAL POLYPROPYLENE RESINS KEYHOLE LIMPET HEMOCYANIN VALOX DR-140 GRADE RESIN CHLORDIAZEPOXIDE HYDROCHLORIDE GENERAL INFO., BURLINGTON PLANT NEW JERSEY 7-METHYLSULFINYLXANTHONE-2-CARBOXYLIC ACID (RS-7337) MANUFACTURING, FACILITIES, PERSONNEL 19-NOR-ANDROSTENEDIONE(NANDROLONE) INHALER DEVICE MELIFORM POLYESTER FILM ENTRENOL DIARIZOIC ACID DYMASIL BRAND DIMETHICONE 350 NORETHINDRONE ENANTHATE K-RESIN BDS POLYMER

4Q2012

POLYETHYLENE RESIN PE 143, 207, AND 178 MANUFACTURED IN ODESSA, TEXAS. MINOCYCLINE HYDROCHLORIDE CAP ANTIPRESS TAB DOXEPIN IRRADIATION STERILIZATION PROCEDURE FACILITIES AND CONTROLS AMITRIPTYLINE HYDROCHLORIDE SOFT LENS COMFORT DROPS--SOFT LENS HYDRAING SOLUTION(TRANS TO DEVICE) 6-IODOMETHYL-19-NORCHOLESTEROL (NP-59) MANUFACTURING & QUALITY ASSURANCE PROCEDURE CAPSEAL BRAND SA-66 CLOSURE LINER & CAPSEAL BRAND SA-22 CLOSURE LINER GLIPIZIDE, BULK TITANIUM TETRAFLOURIDE SOLUTION (MOUTHWASH) LOMUSTINE (CCNU) BULK HYDRALAZINE HYDROCHLORIDE SOLUTION FILLED BLOOD COLLECTION UNITS PHENYLBUTAZONE CELOGEN AZ ETHINYL ESTRADIOL PAPAVERINE HYDROCHLORIDE TRIFLUOROTHYMIDINE SODIUM PARA-AMINOBENZOATE VALOX 310 GRADE RESIN

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4Q2012EXCEL DMF# 2430 2431 2432 2433 2434 2435 2436 2437 2438 A 2439 2440 2441 2442 2443 2444 2445 2446 2447 2448 2449 2450 2451 2452 I 2453 I 2454 2455 2456 2457 2458 2459 2460 2461 2462 2463 2464 2465 2466 2467 I I I A I I I A I I I I I A II I III II III III II III 6/7/1975 5/23/1975 5/28/1975 5/16/1975 5/21/1975 5/9/1975 6/16/1975 6/16/1975 6/3/1975 5/22/1975 6/20/1975 5/26/1975 5/29/1975 6/10/1975 5/23/1975 I I I A I I I I I I I I I II II II II II 4/8/1975 3/25/1975 4/30/1975 4/21/1975 4/2/1975 4/30/1975 5/1/1975 5/7/1975 4/14/1975 5/1/1975 5/6/1975 5/20/1975 5/13/1975 5/21/1975 STATUS Type SUBMIT DATE I I I I A A I I II III III II IV III 4/4/1975 3/11/1975 4/1/1975 4/8/1975 3/14/1975 3/13/1975 4/8/1975 4/9/1975 4/21/1975 HOLDER ANALYTICA CORP MONSANTO COMPANY CHEM AID PHARM SPEC LUDLOW SPECIALTY PAPERS TRI SEAL INTERNATIONAL INC AESICA PHARMACEUTICALS LTD ICI AMERICAS INC RHODIA INC PRIME EUROPEAN THERAPEUTICS SPA EUTICALS SPA RHODIA INC SYNTEX LABS MALLINCKRODT INC LILLY RES LABS DIV ELI LILLY CO MOLECULAR DESIGN INC TAYLOR PHARMACAL CO TRENT PHARMACAL INC NOVO LABORATORIES LTD YAMAKAWA CHEMICAL INDUSTRY CO LTD AMERICAN NATIONAL CAN CO ARMOUR PHARMACEUTICAL CO HUECK & CIE SAUTER SPARKS INC BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE WINTHROP PHARMACEUTICALS DIV STERLING DRUG INC ACCUPAC INC FG OKIE INC P-L BIOCHEMS INC KERR GROUP SUB BERRY PLASTICS CORP HYDRO POLYMERS LTD. INORP SA OAK PARK PHARMACEUTICAL, INC ALLERGAN PHOENIX LABORATORIES INC REHEIS CHEM CO DIV ARMOUR AND CO FM HOWELL AND CO PROQUIMIO LTD TECHNICAL PLASTIC EXTRUDERS INC BRISTOL MYERS SQUIBB CO SUBJECT CHLOROTRIANISENE

4Q2012

PLASTIC CLOSURES AND FITMENTS MADE BY AN INJECTION MOLDING PROCESS PACKAGING HEAT SEAL LABEL PAPER TRI-SEAL LINING MATERIALS FLURBIPROFEN AND SODIUM FLUBIPROFEN ARLAMOL E(PPG-15 STEARYL ETHER) RUBIDAZONE HYDROCHLORIDE RP 22, 050 CHLORTHALIDONE USP AT INST MEDICAMENTA SPA ITALY TETRAMISOLE HYDROCHLORIDE, LEVOROTATORY HEPARIN, SODIUM GALLIUM CHLORIDE (GA-67) ERGONOVINE MALEATE 0.2MG BAROPHANE (LAMINATED PLASTIC SHEET) TEMPORARY FILLING FACILITIES FACILITIES AND CONTROLS SULPHATED INSULIN 3.3.5-TRIMETHYLCYCLOHEXYL MANDELATE (CYCLANDELATE) POLYESTER LIDDING STOCK CALCITONIN-SALMON SYNTHETIC ALUMINUM BLISTER FOIL FACILITIES HYDREA DOPAMINE HYDROCHLORIDE PACKAGING PHARMACEUTICAL IMPRINTING INK-WHITE A8154 THYMUS GLAND FRACTION 3 CLOSURE LINING MATERIALS BEETLE PVC COMPOUNDS FOR MEDICAL APPLICATIONS HEPARIN SODIUM FACILITIES, CONTROLS AND PERSONNEL PLASTIC COMPONENTS STANDARD OPERATING PROCEDURE ZIRCONIUM-ALUMINUM-GLYCINE COMPLEZ (ZAG) PERSONNEL, FACILITIES & CONTROLS HEPARIN TPX SHEETING WARFARIN SODIUM AS MANUFACTURED AT DUPONT CHEMOSWED IN SWEDEN

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4Q2012EXCEL DMF# 2468 I 2469 2470 2471 2472 2473 2474 2475 2476 2477 2478 2479 2480 2481 2482 2483 2484 2485 2486 2487 2488 I 2489 2490 2491 2492 2493 2494 2495 2496 2497 2498 2499 2500 I 2501 2502 I 2503 2504 2505 I I I II 8/4/1975 8/4/1975 8/8/1975 I 7/25/1975 7/28/1975 I I I I I I I I I I I III II II II II II III 9/3/1974 6/25/1975 7/23/1975 6/30/1975 7/18/1975 7/23/1975 8/4/1975 7/25/1975 7/29/1975 6/18/1975 7/28/1975 7/28/1975 ARMOUR PHARMACEUTICAL CO MTC PHARMACEUTICALS SINCLAIR AND VALENTINE MEDIMPEX NORTHAMERICA INC ORGANICHEM CORP GLAXO LABS LTD P-L BIOCHEMS INC COSMECEUTICALS INC UPJOHN CO LUSOCHIMICA S P A ARMOUR PHARMACEUTICAL CO I I N I I I I I I I A I I I I I A I I II I II II III II II III II 6/13/1975 6/17/1975 6/17/1975 7/3/1975 7/3/1975 6/27/1975 6/24/1975 6/20/1975 7/9/1975 7/11/1975 7/3/1975 7/14/1975 7/3/1975 6/12/1975 7/16/1975 7/17/1975 7/18/1975 II II 6/17/1975 6/17/1975 STATUS Type SUBMIT DATE II 6/17/1975 HOLDER PERKINELMER LIFE ANALYTICAL SCIENCES INC EI DUPONT DE NEMOURS AND CO PERKIN ELMER LIFE SCIENCES NOT AN ASSIGNED NUMBER AIR PRODUCTS AND CHEMICALS INC REHEIS CHEM CO DIV ARMOUR AND CO TERRA MARINE BIORESEARCH BURTON,PARSONS & COMPANY,INC. ARMAK INDUSTRIAL CHEMICAL DIV PARKE DAVIS DIV WARNER LAMBERT CO SYNTEX USA INC MALLINCKRODT INC AS SYNTHETICS ALLIED CHEM CORP ACETO CHEMICAL CO INC CIECH POLFA CIECH POLFA CAPTIVE PLASTICS INC RHONE-POULENC SYNTEX USA INC H REISMAN CORP PHENOLPHTHALEIN ALUMINUM-ZIRCONIUMCHLORHYDRATE COMPLEX AZ-4 N-5-METHYLTETRAHYDROFOLIC ACID BUFILCON A --PLASTIC BUTTON FOR HYDROPHILIC SOFT CONTACT LENSES POLYETHYLENE GLYCOL 6000 DISTEARATE PACKAGING OPERATION NAPROXOL PROPIONATE (RS-65198-00-00-1) IOTHALAMIC ACID U.S.P. (ESUB) PHENYLBUTAZONE BULK PETRA POLYESTER SHEET PRODUCT SUFANILAMIDE SULFADIMETHOXINE SULFAGUANIDINE PLASTIC CONTAINERS PRODUCTION FACILITIES & PROCEDURES A VITRY SUR-SEIN PLANT SUBJECT CHROMIUM-51 SELINIUM SE-75 IODINE I-125

4Q2012

7-METHYLTHIOANTHONE-2-CARBOXYLIC ACID (RS-7311) & SODIUM SALT RS-7603 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES FOR BULK AND DOSAGE FORM PACKAGING IN ORANGE , NEW JERSEY. ZINC INSULIN CRYSTALS, INSULIN SALT CAKE (BULK) HEPARIN SILKSCREEN INKS DIHYDROCHLOROTHIAZIDE HYDROCORTISONE-17-VALERATE MEGESTROL ACETATE METHYLENE DIPHOSPHONIC ACID MANUFACTURING PROCEDURES & CONTROLS CYCLOHEXIMIDE (ACTIDIONE) U-4527 XYLOMETAZOLINNE HYDROCHLORIDE ADRENOCORTICOTROPIC HORMONE--HUMAN, SYNTHETIC

AMOCO CHEMS CORP AFFILIATE AMERICAN POLYSTYRENE RESINS OIL CO GANES CHEMICALS INC BETHANECHOL CHLORIDE GANES CHEMICALS, INC., PENNSVILLE DIVISION SYNTEX USA INC SCOTT LABORATORIES INC STIEFEL LABORATORIES INC GUAIFENESIN GLYCERYLGUAIACOLATE RS-40584 SCOTT SB SERIES FILTER SHEETS GAMOPHEN

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4Q2012EXCEL DMF# 2506 2507 I 2508 2509 I 2510 2511 2512 2513 2514 2515 I 2516 2517 A 2518 2519 I 2520 2521 2522 2523 2524 2525 2526 2527 2528 I 2529 2530 2531 2532 2533 2534 2535 2536 2537 2538 2539 2540 2541 I I I I I I I I I I I I I I III IV II II II II II II 9/15/1975 9/18/1975 9/12/1975 10/8/1975 9/25/1975 10/13/1975 10/6/1975 7/23/1975 10/21/1975 10/20/1975 10/23/1975 10/23/1975 10/3/1975 N I I I I I I I II III V II II II 8/21/1975 9/18/1975 6/23/1975 9/4/1974 8/22/1975 8/3/1975 9/24/1975 9/17/1975 NOT AN ASSIGNED NUMBER ATI SEAL BAG COMPANY INC SIGMA F AND D DIV LTD NOVA CHEMICALS USA INCORPORATED KALI EI DUPONT DE NEMOURS AND CO NAPP CHEMICALS INC PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA HOECHST AG H REISMAN CORP MALLINCKRODT INC APOTEKSVARUCENTRALEN VITRUM AB LILLY RES LABS DIV ELI LILLY CO DINAMITE DIPHARMA SPA INDUSTRIA CHIMICA MILANESE SPA GARDENA RUBBER COMPANY INC CILAG CHEMIE AG MALLINCKRODT CHEMICAL WORKS BARNES HIND PHARMACEUTICALS INC FLOW PHARMS INC FOREST LABORATORIES INC PLANT FACILITIES FOR AI EASTERN DIVISION SURGI-PEEL POUCHES AMINO ACIDS: L-ARGININE, FREE BASE AND L-ARGININE, HYDROCHLORIDE POLYSTYRENE RESINS A III 9/4/1975 9/19/1975 SANCAP LINER TECHNOLOGY INC BARNES HIND PHARMACEUTICALS INC A II III 8/28/1975 8/27/1975 I I I I I II IV II II II 8/28/1975 8/26/1975 9/2/1975 8/13/1975 8/22/1975 8/25/1975 UPJOHN MANUFACTURING CO INTERNATIONAL GROUP INC REDEVAN LABS INC KV PHARMACEUTICAL CO ETHYL CORP MOTRIN TAB WAXES & WAX FORMULATIONS TRIPROLIDINE HYDROCHLORIDE PSEUDOEPHEDRINE HCL SRC TOLMETIN (MCN 2559-21-98) I I 8/12/1975 8/15/1975 STATUS Type SUBMIT DATE A II 8/13/1975 8/25/1975 HOLDER TEVA PHARMACEUTICAL INDUSTRIES LTD SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP ADRIA DEVELOPMENT PARTNERSHIP H SUBJECT ALLOPURINOL CARBUTEROL HYDROCHLORIDE (SK&F 40383-A) STALLIMYCIN

4Q2012

PROCTER AND GAMBLE PHARMACEUTICALS FACILITY AND ITS OPERATIONS, PUERTO RICO PLANT INC SUB PROCTER AND GAMBLE CO

ABBOTT LABORATORIES PHARMACEUTICAL I-125-FIBRINOGEN (HUMAN) SENSOR PRODUCTS DIV NOVUS FINE CHEMICALS LLC PSEUDOEPHEDRINE HCL, SULFATE, AND BASE BULK POWDER FLINT HILLS RESOURCES LP POLYPROPYLENE PP23MS, PP23M2CS38, AND PP23M2CS63 MANUFACTURED IN ODESSA, TEXAS. CAP LINER MATERIALS CONTACT LENS CLEANER USED W/BRUCKNER TENITE BUTYRATE LENS(TRANS DEVCS)

QUALIF OF PROFESSIONAL STAFF--(DFORMERLY HELD BY MID-WEST MEDICAL) COPPER-64 (NITRATE & CHLORIDE) CHLOROTHIAZIDE THIORIDAZINE HCL PROCAINE HCL--METHODS, FACILS, CONTROLS USED IN MFG.PROCESS. & PACKING VITAMIN B-12 TRITURATIONS LENPERONE 4'-FLUORO-4-[4-(P-FLUORO-BENZOYL)-PIPERDINO] BUTYROPHENONE BRANCHED-CHAIN AMINO ACID SOLU TYRAMINE HCL INJ ALLOPURINOL AMITRYPTILINE HCL COMPOUND GRC 604-70 TOLMETIN SODIUM DIHYDRATE DIFENOXIN SOFT CONTACT LENS CLEANER PORTA-FLOW DEVICE(HYDROPHILIC LENS STORAGE AND DISINFECTION) SYNCHRON ORAL-CARRIER

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4Q2012EXCEL DMF# 2542 2543 2544 2545 2546 2547 2548 2549 2550 2551 2552 2553 2554 2555 2556 2557 2558 2559 2560 2561 2562 2563 2564 2565 2566 2567 2568 2569 2570 2571 I 2572 2573 2574 2575 2576 2577 2578 2579 2580 I I I I I I I I I II II II I II II 11/13/1975 12/3/1975 12/10/1975 10/31/1975 12/16/1975 12/22/1975 12/17/1975 12/26/1975 12/26/1975 STATUS Type SUBMIT DATE I I I I I I I I I I I I I I I I I I I I I I I A I I I I I II II II II II II II IV III III II III II II III III II I III I III 10/22/1975 10/28/1975 10/31/1975 11/6/1975 11/6/1975 10/31/1975 10/31/1975 11/4/1975 11/12/1975 11/3/1975 11/14/1975 3/8/1976 11/4/1975 11/6/1975 10/31/1975 11/7/1975 11/12/1975 11/21/1975 11/21/1975 8/30/1975 11/13/1975 11/21/1975 11/20/1975 11/12/1975 11/25/1975 12/1/1975 12/5/1975 11/21/1975 7/21/1975 12/17/1975 HOLDER PFANSTIEHL LABORATORIES INC LLOYD MANUFACTURING CO INC CONVERTERS INK CO COMMOMWEALTH SERUM LABS CONTINENTAL CAN COMPANY MEDIMPEX NORTHAMERICA INC MEDIMPEX NORTHAMERICA INC GENERAL ELECTRIC CO BURTON,PARSONS & COMPANY,INC. RESEARCH INDUSTRIES CORP JT BAKER CHEMICAL CO PRINTPACK INC INTERNATIONAL NUTRONICS INC AMERICAN CYANAMID CO 3-M NUCLEAR PRODUCTS HAFSLUND NYCOMED PHARMA AG BURTON,PARSONS & COMPANY,INC. BURTON,PARSONS & COMPANY,INC. BURTON,PARSONS & COMPANY,INC. KV PHARMACEUTICAL CO PHARMA-WALDHOF GMBH SYNTEX USA INC SANWA CHEMICAL COMPANY LTD TEVA PHARMACEUTICAL INDUSTRIES LTD GANES CHEMICALS INC KORO CORP SYNTEX USA INC SIGMA F AND D DIV LTD SIGMA F AND D DIV LTD SCHERING CORP SUB SCHERING PLOUGH CORP EMERY IND INC PFEIFER & LANGEN OTSUKA PHARM CO LTD SIGMA F AND D DIV LTD MK LABORATORIES INC TECHNICAL WAREHOUSE SERVICES INC ER SQUIBB AND SONS INC MANUFACTURING ENTERPRISES INC WESTWOOD SQUIBB PHARMACEUTICALS INC SUBJECT MALTOSE MONOHYDRATE 14-B WHITE RUBBER LINING MATERIAL INK FORMULATIONS INSULIN SALT CAKE & INSULIN CRYSTALS IRRIGATION BOTTLES PHENYLBUTAZONE DIHYDROERGOTOXIN METHANESULPHONATE RADIOISOTOPES FLEXSOL 43 PLASTIC BUTTON DIMETHYL SULFOXIDE (DMSO) MASTER FACILITIES COMPOSITE CONSTRUCTION LAYER FILMS

4Q2012

FACILITY DESCRIPTION & PERSONNEL (THIS DFORMERLY HELD BY RSA CORP) XT ACRYLIC POLYMER FACILITIES, PERSONNEL METHODS AND CONTROLS HEXOPRENALINE SULFATE ADAPETTES, (LUBRICAING SOLUTION) FLEXSOL 55 PLASTIC BUTTON FLEXSOL 72 PLASTIC BUTTON ACETAZOLAMIDE 500MG SRC GLUTAHIONE, OXIDIZED HYDRATE MANUFACTURING FACILITIES AND CONTROLS (NASAL+-SUFFLATOR SYSTEM) CYCLANDELATE FUROSEMIDE MANUFACTURED IN PETAH TIQVA, ISRAEL. DIETHYLPROPION HYDROCHLORIDE KORACRYL THERMOPLASTIC SHEETING TRALONIDE TAURINE D-PHENYLALANINE MANUFACTURING AND CONTROL (PALACOS W/GENTAMICIN) SPECS & COMPOSITION EMERSOL 315-LINLEIC ACID MANUFACTURING AND DESCRIPTION (DEXTRAN) MANUFACTURING FACILITIES AND SPECS--MALTOSE SUGAR DL-N-5-METHYLTETRAHYDROFOLIC ACID, SODIUM PLANT FACILITIES AND CONTROLS MANUFACTURING FACILITIES AND CONTROLS MANUFACTURE AND CONTROLS (AMPHOTERICIN B, METHYL ESTER) HALOG (HALCINONIDE) 0.1% SOL. HALOG (HALCINONIDE 0.1% OINTMENT) MANUFACTURED IN HUMACAO, PR

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4Q2012EXCEL DMF# 2581 2582 2583 2584 2585 I 2586 2587 2588 2589 I 2590 2591 2592 2593 2594 2595 2596 2597 2598 2599 I 2600 2601 2602 2603 2604 A 2605 2606 2607 2608 I 2609 2610 2611 2612 I 2613 2614 2615 2616 I A I A II I II 1/30/1976 2/17/1976 3/1/1976 2/27/1976 I A I III V III 2/6/1976 2/18/1976 2/2/1976 3/1/1976 I I I II III 2/18/1976 2/5/1976 2/23/1976 2/24/1976 I I I I II II I 1/29/1976 2/10/1976 2/12/1976 2/13/1976 2/19/1976 I I I I I N I I A II II II III 1/16/1976 1/16/1976 1/28/1976 1/29/1976 II II II I 1/19/1976 1/20/1976 1/23/1976 1/23/1976 1/23/1976 I I I II II 12/19/1975 12/17/1975 11/28/1975 1/13/1976 STATUS Type SUBMIT DATE I I I A II II IV II 12/15/1975 1/6/1976 12/16/1975 12/19/1975 12/19/1975 HOLDER AMERICAN LABS DELMAR CHEMS LTD NEN LIFE SCIENCE PRODUCTS EVONIK ROHM GMBH SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP LONZA RIVERSIDE CHOAY SA EASTMAN KODAK CO OPOCRIN LABORATORIO FARMACOBIOLOGICA SB PENICK AND CO ORIG UPJOHN CO PHENCHEM INDUSTRIES LTD PHENCHEM INDUSTRIES LTD PHENCHEM INDUSTRIES LTD NOT AN ASSIGNED NUMBER SIGMA F AND D DIV LTD SIGMA F AND D DIV LTD SIFAVITOR SRL SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP PHARMACEUTICAL PACKAGING SERVICES MALLINCKRODT INC SG HAUSER ASSOCIATION INC MOBAY CHEMICAL CORP JOHNSON MATTHEY PHARMACEUTICAL MATERIALS A SCHULMAN INC FALK GMBH AND CO AMERICAN MIRREX CORP SYNTEX LABORATORIES INC SUB SYNTEX CORP CURWOOD INC 3M DRUG DELIVERY SYSTEMS SIGMA F AND D DIV LTD CIBA GEIGY CORP PHARMACEUTICAL DIVISION SPECIALTY PAPERS CO FERRO PFANSTIEHL STARKS ASSOCIATES INC SCIENTIFIC PROTEIN LABORATORIES LLC 5 ALPHA-ANDROSTAN-17B-OL-3-ONE (5 ALPHA-DIHYDROTESTOSTERONE) B-MERCAPTOCTHYLAMINE HYDROCHLORIDE (CYSTEAMINE) AMITRIPTYLINE HCL PRODUCTION OF PLASTIC BOTTLES METHODS AND PROCESSES FOR PACKAGING AND LABELING THALLOUS CHLORIDE (T1-201) SOFT LENS STERILIZER MERLON PRODUCTS AMPHETAMINE SULFATES 1B-35A PELLETS (IV BAG) --MANUFACTURING SPECIFICS. CHENOFALK(CHENODEOXYCHOLIC ACID) MIRREX (MCFD-1047 CLEAR) (FORMERLY HELD BY TENNECO CHEMICALS) FACILITIES AND CONTROLS PRODUCT SPEC. AND TOXICITY TESTS RVCY 700 RIGILAM BC HIPS SCOTCHPAK FILMS PHOSPHORYLCHOLINE CHLORIDE, CA SALT HEMAC POLYMER NETWORKS PACKAGING CONSTRUCTIONS (CEFE, CE-1, CE-2) STREPTOZOTOCIN FACILITIES AND CONTROLS HEPARIN SODIUM SUBJECT OPERATING PROCEDURE NO. 180 (CALF THYMUS-FRACTIONS) DIAZEPAM USP BULK-MANUF AT LA SALLE, QUEBEC FACILITIES GALLIUM-68 MFG IN NO. BILLERICA, MA EUDRAGIT L 30 D-55

4Q2012

MANUFACTURING, FACILITIES AND CONTROLS (CHLORDIAZEPOXIDE HCL USP) TRIAMTERENE, USP AS MANUFACTURED IN CONSHOHOCKEN, PA) HEPARIN CALCIUM GUANIDINE HCL PLANT FACILITIES AND CONTROLS ALPHACETYLMETHADOL HCL (LEVOROTATORY) GEN. INFO APPLICABLE TO THE FINE CHEMICAL OPERATIONS IMIPRAMINE HCL PROCHLORPERAZINE MALEATE TRIFLUOPERAZINE HCL

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4Q2012EXCEL DMF# 2617 2618 2619 2620 2621 2622 2623 2624 2625 2626 2627 2628 2629 I 2630 2631 2632 2633 I 2634 2635 2636 2637 2638 2639 2640 2641 2642 2643 2644 2645 I 2646 I 2647 2648 2649 2650 2651 2652 2653 2654 I I I N I I I I II I II III 4/26/1976 4/6/1976 4/19/1976 4/22/1976 II II 4/7/1976 4/8/1976 4/2/1976 3/30/1976 I I A N N I I I I I N 4/6/1976 II II 3/8/1976 3/18/1976 3/25/1976 3/19/1976 3/23/1976 V IV 3/12/1976 3/8/1976 3/25/1976 I I I II II II 2/19/1976 3/18/1976 3/5/1976 3/1/1976 STATUS Type SUBMIT DATE I I I I I I I I I I N I III III 1/21/1976 3/18/1976 II II II I 3/2/1976 3/2/1976 3/9/1976 3/4/1976 3/2/1976 2/4/1976 2/11/1976 3/11/1976 3/10/1976 3/23/1976 HOLDER SYNTHETIC PRODUCTS CO HENKEL INC PLANTEX LTD CHEM AND PHARM WORKS KYOWA HAKKO USA INC KYOWA HAKKO USA INC KYOWA HAKKO USA INC KYOWA HAKKO USA INC KYOWA HAKKO USA INC BORG-WARNER CHEMICALS DELMAR LABS NOT AN ASSIGNED NUMBER AVERY DENNISON SPECIALTY TAPE DIV ADHESIVE SYSTEMS STEVENS ELASTOMERIC & PLASTIC PRODS MX-1834 E.P.D.M. I.V. STOPPER FORMULATION SUB JP STEVENS & CO INC CYCLO PRODUCTS INC TRIPROLIDINE HCL(THIS DFORMERLY HELD BY TRAVENOL LABS, INC) KYOWA HAKKO KOGYO CO LTD AS SYNTHETICS INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA EASTMAN CHEMICAL CO CENTERCHEM INC BELL MORE LABS INC NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER CENTERCHEM INC ROUSSEL-UCLAF SYNTEX USA INC AYERST LABORATORIES INC BARNES HIND PHARMACEUTICALS INC NOT AN ASSIGNED NUMBER BECKMAN INSTRUMENTS INC DIV SMITHKLINE BECKMAN CORPORATION SCHERING CORP SUB SCHERING PLOUGH CORP LILLY RES LABS DIV ELI LILLY CO MONSANTO COMPANY SOLMAG SPA NOT AN ASSIGNED NUMBER ANTIBIOTICOS SPA AZIENDE CHIMICHE RIUNITE MALLINCKRODT INC BORDEN CHEM CO TRIAMCINOLONE ACETONIDE FACILITIES IN APRILIA, ITALY SELENOMETHIONINE PVC HOMOPOLYMER RESINS SYNTHETIC ANGIOTENSIN III MANUFACTURING PROCEDURES EPHEDRINE SULFATE HEXAMETHYLENE DIAMINETETRA ACID (METHYLENE PHOSPHONIC) FUROSEMIDE SODIUM HEPARIN DELTA-5 (10)-NORANDROSTENEDIONE CLOPREDNOL AY-24,910 SOMATOSTATIN AMINO ACIDS SULFAMETHIZOLE INDOMETHACIN TENITE BUTYRATE (FOR CONTACT LENS) PAPAIN FILLING & FREEZE DRYING METHODS FOR IN-VIVO MATERIAL SUBJECT SYNPRON 1005 VINYL HEAT STABILIZER LOXIOL GH-4 AND LOXIOL G-70 FACILITIES AND PROCEDURES L-CYSTINE AND L-CYSTINE MONOHYDROCHLORIDE L-ALANINE L-LEUCINE L-ISOLEUCINE--MANUFACTURING INFO AMINO ACIDS--GENERAL INFO ON BULK DRUG SUBSTANCES CYCOPAC 930 MANUFACTURING FACILITIES

4Q2012

B-H SOFT LENS RINSING AND BOILING SOLUTION-HYDROCURVE(TRANS-DEVICES)

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4Q2012EXCEL DMF# 2655 2656 2657 2658 I 2659 2660 2661 2662 2663 2664 2665 2666 2667 2668 2669 2670 2671 2672 2673 2674 I 2675 2676 2677 2678 I 2679 2680 2681 2682 I 2683 2684 2685 2686 2687 2688 2689 2690 2691 2692 I I A I I I I I I I II III III II II III II 6/16/1976 6/15/1976 6/6/1976 6/10/1976 5/24/1976 5/24/1976 6/9/1976 5/27/1976 5/27/1976 6/22/1976 I I I II I I 5/3/1976 3/25/1976 5/27/1976 6/3/1976 I I I II II II III 5/20/1976 5/20/1976 5/4/1976 6/8/1976 ROUSSEL CORPORATION GANES CHEMICALS INC ORGANON INC I I I I A I I I I I I I I I I III II I I II II II II I I II 4/13/1976 4/20/1976 5/4/1976 4/9/1976 5/7/1976 4/28/1976 4/30/1976 5/7/1976 3/22/1976 5/4/1976 5/10/1976 4/29/1976 5/13/1976 5/10/1976 5/13/1976 5/21/1976 STATUS Type SUBMIT DATE I I I II I 4/1/1976 4/1/1976 4/26/1976 4/22/1976 HOLDER PIERREL SPA PIERREL SPA ANTIBIOTICOS SPA MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC 3M PHARMS SCHERING PLOUGH LABO N V SIGMA F AND D DIV LTD THERMOPLASTIC PROCESSES INC DOTTIKON EXCLUSIVE SYNTHESIS AG HOFFMANN LA ROCHE INC B BRAUN MEDICAL INC CONTINENTAL PHARMA SA DIOSYNTH INTERNATL NV LONZA RIVERSIDE N&N MENICON INC CILAG CHEMIE AG OTSUKA PHARM CO LTD PCR INC BARNES HIND PHARMACEUTICALS INC MERCK MANUFACTURING DIVISION SUBJECT TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ALCOHOL SPIRONOLACTONE MANUFACTURE AND CONTROL 3M BRAND TRACER MICROSPHERES METHODS,FACILITIES AND CONTROLS FOR ESSEX LABO NV BELGIUM AMINO ACIDS & THEIR SODIUM SALT DERIVAIVES RELAIVE TO HFN-130 INDS BEV-A-LINE ISOSORBIDE DINITRATE LACTOSE 25:75% LEVODOPA INJECTABLE PERSONNEL SULACTIDIL METHYLTESTOSTERINE TRIMEPRAZINE TARTRATE MAFILCON, SOFT CONTACT LENS MATERIAL PRODUCTION & CONTROL(HOLDER NAME CHANGED 4.9.81 TO CILAG AG) CARTEOLOL HCL, MANUFACTURED IN TOKUSHIMA, JAPAN CHLORDIAZEPOXIDE AND CHLORDIAZEPOXIDE CHL BARNES-HIND SOFT LENS RINSING AND BOILING SOLUTION

4Q2012

INJECTION AND EXTRUSION BLOW MOLDED CONTAINERS MANUFACTURED IN WEST POINT, PA FLUPREDNYLIDENE-21-ACETATE DISODIUM ETIDRONATE ESTRADIOL

WAITAKI INTERNATIONAL BIOSCIENCES SUB CARIX WAITAKI CANADA LTD PHARMACEUTICAL BASICS INC MANUF, QUALITY CONTROL & OPERATIONAL PROCEDURES UNION CARBIDE CORPORATION DRUGS INC TERGITOL ANIONIC SURFACTANT 4 CHLORDIAZEPOXIDE HCL

SOCIETE INDUSTRIELLE POUR LA CHIMIE SICOR SA FACILITIES IN LIMAY, FRANCE ORGANIQUE ET LA RECHERCHE SICOR MELWOOD STEELE CENTER ITERNATIONAL FORMULA - HG/MJS DAIICHI SEIYAKU CO LTD SELIG SEALING PRODUCTS INC ALDEN OPTICAL LAB INC ANTIBIOTICOS SPA ANTIBIOTICOS SPA VOLTEK INC GANES CHEMICALS INC GANES CHEMICALS INC GEORGE F DEFONEY PHARMACEUTICAL EPIRIZOLE (MEBRON) W SERIES OF CAP-SEAL BRAND CLOSURE LINER(W-77) 2-HYDROXYETHYL METHACRYLATE AL-47 MONOMER PROGESTERONE 16A, 17A- ACETOPHENIDE METHYLPREDNISOLONE AND METHYLPEDNISOLONE ACETATE MINICEL(R) L-200 FOAMS (CROSS LINKED POLYETHYLENE FOAM) PHENTERMINE HCL XYLOMETAZOLINE HCL SODIUM HEPARIN

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4Q2012EXCEL DMF# 2693 2694 2695 2696 2697 2698 2699 2700 A 2701 2702 2703 2704 I 2705 2706 2707 2708 2709 2710 2711 2712 2713 2714 2715 2716 A 2717 2718 I 2719 2720 2721 2722 2723 2724 2725 2726 2727 I 2728 I I 8/30/1976 A I I I I I I A II I II II II II II II III 8/9/1976 8/16/1976 3/27/1976 8/16/1976 8/5/1976 8/11/1976 8/13/1976 8/5/1976 7/28/1976 I II I 5/25/1976 7/28/1976 I I I I I I I A I I I I II II II II IV II II II II II 7/5/1976 7/1/1976 7/19/1976 7/8/1976 7/15/1976 7/19/1976 7/9/1976 8/3/1976 7/22/1976 7/21/1976 7/30/1976 8/10/1976 SORIN BIOMEDICA SPA HOECHST MARION ROUSSEL HERCULES INC NAPP CHEMICALS INC EI DUPONT DE NEMOURS AND CO MEDIMPEX NORTHAMERICA INC XYROFIN AG PFIZER INC LUSOCHIMICA S P A ANALYTICA CORP DOW CHEMICAL CO MICHIGAN DIV SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE WEDDEL PHARMS LTD SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP TEVA PHARMACEUTICAL INDUSTRIES LTD PHARMACIA AND UPJOHN INC FARMABOIS AINC SOCIETE CHIMIQUE POINTET GIRARD SA ANTIBIOTICOS SPA MANUFACTURING ENTERPRISES INC BAYER SCHERING PHARMA AG UNIVERSAL SHELLAC & SUPPLY COMPANY INC AEROJET-GENERAL CORPOATION, PROPULSION DIVISION. I I I II I 6/2/1976 6/11/1976 6/21/1976 6/15/1976 CV CHEMIE COMBINATIE NYEGAARD AND CO AS CHEMAPOL LTD DIFFUCAP SA STATUS Type SUBMIT DATE A I I I I A I I II II II II V II 6/16/1976 6/23/1976 6/14/1976 6/2/1976 6/9/1976 6/21/1976 6/10/1976 6/25/1976 HOLDER FIDIA FARMACEUTICI SPA H REISMAN CORP JANSSEN PHARMACEUTICA INC ANTIBIOTICOS SPA GANES CHEMICALS INC SIEGFRIED LTD CHEMAPOL LTD B BRAUN MEDICAL INC SUBJECT BENZHEXOL HCL. (TRIHEXYPHENIDYL HCL.) RESERPINE -LACTOSE TRITURATIONS

4Q2012

FACILS & COMTRLS-JANSSEN PHARMA. N.V.-BELL TELEFOONLAAN, GEEL, BELGIUM METHYLDOPA USP ISOPROTERENOL HCL AND ISOPROTERENOL SULFATE PROPARACAINE HCL DIHYDROERGOTOXINE METHANE SULFONATE STERILIZATION OF LARGE VOL PARENTERAL SOL (ESUB) AS MANUFACTURED IN IRVINE CA L (-) LACTIDE METRIZOIC ACID LYSENYL (LISURIDE HYDROGEN MALEATE) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SWITZERLAND. MANUFACTURING PROCESS MANUFACTURING FACILITY CROSSLINKED SODIUM CARBOXYMETHYLCELLULOSE (AQUALON ABSORB. FIBERS) LIDOCAINE, USP CALCIUM-45 CLOFIBRATE XYLITOL HEPARIN, SODIUM U.S.P. DILUTED ISOSORBIDE DINITRATE TRIPROLIDINE HCL, NF PROPOXYPHENE HCL, USP CIMETIDINE AND CIMETIDINE HCL MANUFACTURED IN CORK, IRELAND. HEPARIN SODIUM USP CIMETIDINE AND CIMETIDINE HCL AMITRIPTYLINE HCL FACILS. AND CONTROL SPECIFS IN KALAMAZOO, MICH. FACILITY (IBUPROFEN) 6-ALPHA-METHYL-PREDNISOLONE N.F. ZETA PLUS 'CP' & 'SP' FILTER MEDIA FOR PHARMACEUTICAL USE QUINIDINE GLUCONATE MEDROXYPROGESTERONE ACETATE TRIAMCINOLONE ACETONIDE 10% NORETHINDRONE LENS POLISHING PITCHES, LENS BLOCKING PITCHES AND STACKING WAX FACILITIES AND CONTROLS

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4Q2012EXCEL DMF# 2729 2730 2731 2732 2733 2734 I 2735 2736 A 2737 2738 2739 I 2740 2741 2742 2743 I 2744 2745 2746 2747 2748 2749 2750 2751 2752 2753 I 2754 2755 2756 2757 2758 2759 2760 I 2761 I 2762 2763 I I II 9/28/1976 9/27/1976 10/14/1976 WINTHROP PHARMACEUTICALS DIV STERLING DRUG INC CYCLO PRODUCTS INC MALLINCKRODT INC I I I A I I II I II II I 10/27/1976 10/26/1976 10/26/1976 10/8/1976 9/27/1976 8/10/1976 10/5/1976 AINC MERCK SHARP & DOHME RESEARCH LABS MERCK SHARP & DOHME RESEARCH LABS 3M DRUG DELIVERY SYSTEMS KV PHARMACEUTICAL CO BUCHLER AND CO I I I A I I A I I III II I II I II III III II 9/9/1976 8/18/1976 8/10/1976 8/2/1976 8/20/1976 6/7/1976 9/15/1976 9/17/1976 8/13/1976 10/15/1976 I I I III II II 9/3/1976 9/3/1976 9/1/1976 8/23/1976 I A II II II 7/19/1976 8/2/1976 8/30/1976 ROUSSEL CORPORATION FIDIA FARMACEUTICI SPA I II II 8/10/1976 7/19/1976 STATUS Type SUBMIT DATE A I I I I II III II II II 9/3/1976 8/27/1976 8/25/1976 8/30/1976 8/20/1976 9/2/1976 HOLDER GANES CHEMICALS INC CORD LABORATORIES INC VERNAY LABORATORIES INC NOVO NORDISK AS CELANESE PLASTICS BECKMAN INSTRUMENTS INC DIV SMITHKLINE BECKMAN CORPORATION ROUSSEL CORPORATION SANOFI CHIMIE SUBJECT BRETYLIUM TOSYLATE THEOPHYLLINE CAPS., 250MG ELASTOMER FORMULATION VL 201 N 46 INSULIN (SALT CAKE AND CRYSTALS) CELGARD MICROPOROUS FILM AND HOOLOW FIBER PRODUCTS SYNTHETIC BOVINE PARAHYROID HORMONE (1-34) PEPTIDE HEMATOPORPHYRIN BASE

4Q2012

DEXAMETHASONE ACETATE ANHYDROUS USP MANUFACTURED IN VERTOLAYE, FRANCE. DEXAMETHASONE SODIUM METASULFOBENZOATE DIETHYLPROPION HCL.

PLIVA PHARMACEUTICAL CHEMICAL FOOD & SULFISOXAZOLE COSMETIC INDUSTRY ER SQUIBB AND SONS INC KENALOG LOTION ER SQUIBB AND SONS INC ROCHE PRODUCTS INC ONYX CHEM CO DIV MILLMASTER ONYX CORP PHARM ECO LABORATORIES INC HOFFMANN LA ROCHE INC AMERICAN NATIONAL CAN CO 3M DRUG DELIVERY SYSTEMS WESTWOOD-SQUIBB BORG-WARNER CHEMICALS DUPONT ENGINEERING POLYMERS NAPP CHEMICALS INC DELVCO INDUSTRIES INC KYOWA HAKKO KOGYO CO LTD TRIAMCINOLONE ACETONIDE CONCENTRATE L MAPROLYTE XL AND LX FACILITIES FOR PHARM-ECO LABS RO 21-5816/000 24R,25-DIHYDROXYCHOLECALCIFEROL LAMINATED PACKAGING FILMS (THIS FORMERLY HELD BY CONTINENTAL CAN CO.) SCOTCHPAK BRAND FILMS KENALOG CREAM (THIS DFORMERLY HELD BY MANUFACTURING ENTERPRISES,INC CYCOPAC PRODUCTS PART 2 DELRIN (R) ACETAL RESIN N-ACETYL PROCAINAMIDE HCL PACKAGING GUIDELINE L-CYSTINE & DERIVATIVE L-CYSTINE HCL & N-ACETYL-L-CYSTEIN MANUFACTURED IN SAKAI, OSAKA, JAPAN. ZETA/PLUS PRE-TEK (3 NORMAL DIAMETER) CARTRIDGES FOR PHARMACEU. USE FACILITIES & CONTROLS FOR MERCK FROSST LABS FOR TROCOSONE TROCOSONE CORDRAN (FLURANDRENOLIDE) TAPE HYBEPHEN -LA CAPSULES QUINIDINE SULFATE AND QUINIDINE PRODUCTS

PROCTER AND GAMBLE PHARMACEUTICALS MANUFACTURING PROCESS AND FACILITY AT NORTH NORWICH, NY INC SUB PROCTER AND GAMBLE CO SYNTHESIS & QUALITY CONTROLS FOR 5,7-DICHLORO-8-HYDROXYQUINOLONE SYNTHESIS OF DIETHYLPROPIN HCL, NF XIV TOLMETIN SODIUM DIHYDRATE--MANUFACTURING PROCEDURES

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4Q2012EXCEL DMF# 2764 2765 2766 2767 2768 I 2769 2770 2771 2772 2773 2774 2775 2776 2777 2778 2779 2780 2781 2782 2783 2784 2785 2786 2787 2788 I 2789 2790 2791 2792 2793 2794 2795 2796 2797 2798 2799 2800 2801 2802 A I I I I I I I I I I I I I II III II II II III III II II II 11/11/1976 11/10/1976 11/12/1976 11/24/1976 10/18/1976 11/15/1976 11/23/1976 11/24/1976 11/18/1976 11/12/1976 12/13/1976 11/30/1976 11/8/1976 12/10/1976 I I I I I I I I A I I A I I I I I I I I I II II II II II II II II IV IV II 10/8/1976 10/1/1976 10/1/1976 10/1/1976 10/25/1976 10/25/1976 10/1/1976 10/1/1976 10/20/1976 10/22/1976 11/2/1976 10/29/1976 10/21/1976 10/28/1976 10/29/1976 11/4/1976 11/5/1976 11/16/1976 11/2/1976 11/19/1976 STATUS Type SUBMIT DATE I I I C II II II I 10/5/1976 10/12/1976 11/2/1976 11/2/1976 11/3/1976 HOLDER BF GOODRICH COMPANY SIGMA F AND D DIV LTD ABBOTT LABORATORIES TEVA PHARMACEUTICAL INDUSTRIES LTD 4 QUATRUM-EMPRESA NACIONAL DE QUIMICA ORGANICA SARL BACON AND THOMAS BF GOODRICH COMPANY POLYSAR INC BF GOODRICH COMPANY B BRAUN MEDICAL INC ORGANON INC GANES CHEMICALS INC SIEGFRIED AG SIEGFRIED USA INC SIGMA F AND D DIV LTD SIGMA F AND D DIV LTD SIGMA ALDRICH MANUFACTURING LLC LESCARDEN LTD MONSANTO RES CORP DIV MONSANTO CO ISOMEDIX INC PCR INC ORGANICHEM CORP BARR LABORATORIES INC ANTIBIOTICOS SPA SUBJECT VYNALOY COMPOUNDS L-VALINE ESTERIFIED ESTROGENS USP CONJUGATED ESTROGEN USP POWDER FACILS., CONTROLS AND DRUG SYNTHESIS AND PRODUCT INFORMATION HEPARIN SODIUM AMERIPOL POLYMERS, EPCAR POLYMERS AND HYCAR POLYMERS EPCAR POLYMERS HYCAR POLYMERS (1022) BRANCHED CHAIN AMINO ACID SOLUTION CONJUGATED ESTROGENS PROBENECID XIPAMIDE PROPOXYPHENE HYDROCHLORIDE L-LEUCINE DIHYDROXYACETONE PATENT BLUE VIOLET CARIX-S INJECTION GMP RELAING TO THE MANUFACTURE OF BULK PHARMACEUTICALS

4Q2012

FACILS & CONTROLS FOR IRRADIATION PROCESSING-COLUMBUS, MISS. FACILITY FTORAFUR TRIHEXYPHENIDYL HCL MANUFACTURING AND CONTROLS FLUOCINOLONE ACETONIDE

ABBOTT LABORATORIES PHARMACEUTICAL LIFE CARE FLEXIBLE CONTAINERS PRODUCTS DIV SANOFI AVENTIS CHIMIE HYDROCORTISONE USP MALLINCKRODT INC ACIC LTD ST ONGE MAYERS STEWARD & REENS ANTIBIOTICOS SPA B BRAUN MEDICAL INC INEOS ACRYLICS UK LIMITED MALLINCKRODT INC HERCULES INC CONNAUGHT LABORATORIES INC BAYER CORP ORGANICS DIV LA GRANGE INC SANOFI PHARMACEUTICALS INC DIAGNOSTIC ISOTOPES INC TOLMETIN SODIUM DIHYDRATE T.A. PHENFORMIN HCL GLOVE JUICE TEST BECLOMETHASONE 17, 21- DIPROPIONATE PLASTIC LARGE VOLUME PARENTERAL CONTAINERS PERSPEX CQ POLYMETHYLMETHACRYLATE SHEET OXYCODONE TEREPHTHALATE PENTRINITROL ISOPHANE INSULIN SUSPENSION USP (NPH) COMPLETE BUTYL PRODUCT LINE MANUF AT THE SARNIA FACILITY NATURAL ESTROGENIC SUBSTANCE LIDOCAINE HCL XENON, XE-127

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4Q2012EXCEL DMF# 2803 A 2804 2805 2806 2807 2808 2809 2810 2811 2812 2813 2814 I 2815 2816 2817 2818 2819 2820 2821 2822 2823 2824 2825 2826 2827 2828 2829 2830 2831 2832 2833 2834 I 2835 2836 A 2837 I 2838 I 1/25/1977 II 1/27/1977 I III 1/13/1977 1/26/1977 KOLMAR LABORATORIES INC SABIC INNOVATIVE PLASTICS I I I I I I I A I I I I I N I I I I I II I 1/26/1977 12/30/1976 12/23/1976 1/28/1977 1/12/1977 1/13/1977 II II II II II II II IV II III 12/14/1976 12/16/1976 1/7/1977 1/3/1977 1/22/1977 1/25/1977 1/4/1977 12/23/1976 12/23/1976 12/8/1976 10/27/1976 1/24/1977 1/25/1977 I I I I I A I A I I II IV II II II 12/1/1976 11/22/1976 12/1/1976 11/22/1976 11/29/1976 12/10/1976 12/10/1976 12/6/1976 12/23/1976 12/22/1976 12/15/1976 STATUS Type SUBMIT DATE V 12/10/1976 HOLDER NATIONAL INSTITUTES HEALTH NATIONAL CANCER INSTITUTE DIV CANCER TREATMENT SIEGFRIED AG KESTREL STANFORD RES INST INDUSTRIA CHIMICA PROFARMACO SPA INDUSTRIA CHIMICA PROFARMACO SPA FIDIA FARMACEUTICI SPA INST CHEMIOTERAPICO ITALIANO DOW CORNING CORP CORNEAL SCIENCES INC SYNTEX USA INC INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA ORGANON INC ORGANON INC CILAG CHEMIE AG KV PHARMACEUTICAL CO SYNTEX USA INC LILLY RES LABS DIV ELI LILLY CO MALLINCKRODT CHEMICAL INC EVONIK ROHM GMBH UNION CARBIDE CORPORATION WRAPS INC CENTERCHEM INC BARNES HIND PHARMACEUTICALS INC BARNES HIND PHARMACEUTICALS INC NOT AN ASSIGNED NUMBER BARNES HIND PHARMACEUTICALS INC SIGMA F AND D DIV LTD H REISMAN CORP LAKE AND CRUICKSHANK TEVA PHARMACEUTICAL INDUSTRIES LTD KOLMAR LABORATORIES INC BARNES-HIND STORAGE CASE FOR SOFT CONTACT LENSES CYCLOHEXIMIDE KETAZOLAM QUINIDINE PRODUCTS ACETAZOLAMIDE SUBJECT PRECLINICAL EVALUATIONS

4Q2012

DIETHYLPROPION HCL THERMAL DISINFECTION UNIT, CONTACT LENS CARRYING/STORAGE CASE-FACILS PHARMACEUTICAL ANALYSIS HYDROXYZINE HCL HYDROXYZINE PAMOATE CLIDINIUM BROMIDE SULFAMETHOXAZOLE MDX-4-4210 CLEAN GRADE ELASTOMER CRAFILCON A (TM) SOFT CONTACT LENSES SYNTHESIS OF RS-40974-00-00-0 CHLORTHALIDONE DEXAMETHASONE ACETATE DEXAMETHASONE AMANTADINE HCL POTASSIUM CHLORIDE SUSTAINED RELEASE CAPSULES 600MG RS-44872-00-10-3 (D,L-1[2,4-DICHLORO-BETA-[4-CHLOROBENZYL)THIO]PHENETH EMETINE HCL INJECTION OXYCODONE HYDROCHLORIDE PURIFIED RECRYSTALLIZED EUDRAGIT E 30 D ACRYLATE ESTER COPOLYMER COATING XENON-133 PL AND XENON-133 P2 LAMINATES AND FILM-COATED PAPERS COSMETIC COLLAGEN BARNES-HIND CLEANING SOL'N FOR SOFT CONTACT LENSES (TRANS. TO DEVICES) BARNES-HIND RINSING SOLUTION FOR SOFT CONTACT LENSES(TRANS.TO DEVICES)

MANUFACTURING SITE FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. MANUF & PACKAGING OF DRUG PRODUCTS A THE MILWAUKEE, WIS. FACILITY

VALOX * RESINS AS MANUFACTURED IN MT VERNON, INDIANA (USA), AND BERGEN-OPZOOM, THE NETHERLANDS. WAITAKI INTERNATIONAL BIOSCIENCES SUB CHYMOTRYPSIN AND/OR TRYPSIN WAITAKI CANADA LTD BARNES HIND PHARMACEUTICALS INC STORAGE AND RINSING SOLUTION FOR SOFT CONTACT LENSES(TRANS.TO DEVICES)

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4Q2012EXCEL DMF# 2839 2840 2841 2842 2843 2844 2845 2846 I 2847 I 2848 2849 2850 2851 2852 2853 2854 2855 2856 2857 2858 2859 2860 2861 2862 2863 I 2864 2865 2866 2867 2868 2869 I 2870 2871 2872 2873 2874 2875 2876 A I A I A I I II II II II II II 2/18/1977 2/18/1977 3/1/1977 3/4/1977 2/28/1977 2/10/1977 2/24/1977 TEVA PHARMACEUTICAL INDUSTRIES LTD PLANTEX LTD CHEM AND PHARM WORKS TEVA PHARMACEUTICAL INDUSTRIES LTD TROPONWERKE GMBH CO KG SANOFI AVENTIS CHIMIE UCB PHARMACEUTICALS BUCKEYE CELLULOSE CORP I I I I I II II I II II 2/24/1977 2/24/1977 2/10/1977 3/7/1977 2/24/1977 2/16/1977 I I I I I A I A I I I I I I I II I II II IV II II II II 1/28/1977 1/26/1977 1/26/1977 1/26/1977 1/26/1977 2/1/1977 2/3/1977 2/8/1977 2/16/1977 2/10/1977 1/19/1977 2/10/1977 2/15/1977 2/7/1977 2/10/1977 2/2/1977 II 2/4/1977 STATUS Type SUBMIT DATE A I I A I I I III II II III II 1/1/1977 2/4/1977 2/4/1977 1/14/1977 2/7/1977 1/3/1977 9/16/1976 2/2/1977 HOLDER SEKISUI VOLTEK LLC DELMAR CHEMS LTD DELMAR CHEMS LTD ORACLE FLEXIBLE PACKAGING SIGMA F AND D DIV LTD UNITED STATES STEEL CORP MIRANOL CHEM CO SUBJECT VOLARA FOAMS---CROSS-LINKED POLYETHYLENE FOAMS TOLBUTAMIDE (COARSE) TOLBUTAMIDE (FINE) COMPOSITION AND MANUF PROCESSES FOR PACKAGING MATERIAL CHOLIC ACID SODIUM SALT POLYSTYRENE COMPOUNDS MIRAMINE (R) TA 30

4Q2012

TRUETT LABS DIV SOUTHWESTERN DRUG FACILITIES AND CONTROLS CORP PLIVA PHARMACEUTICAL CHEMICAL FOOD & MECLIZINE HCL COSMETIC INDUSTRY BARNES HIND PHARMACEUTICALS INC BOILING AND RINSING SOLUTION FOR SOFT CONTACT LENSES(TRANS.TO DEVICES) BLASCHIM SPA BLASCHIM SPA BLASCHIM SPA BLASCHIM SPA TRIFARMA SPA NATL INST HLTH CLINCL CTR PHARMACY BASF CORP UPJOHN CO GANES CHEMICALS INC API SYSTEM SA TAKEDA CHEMICAL INDUSTRIES LTD LONZA INC RP SCHERER CORP SCHERING AG DEXAMETHASONE 21 SODIUM PHOSPHATE PREDNISOLONE 21 DISODIUM PHOSPHATE TRIAMCINOLONE DIACETATE TRIAMCINOLONE ALCOHOL TRIFLUOPERAZINE HYDROCHLORIDE NF XIV LYMPHILIZED PRODUCT OF AMINOPTERIN (NSC 739), 50MG KOLLIDON (R)POLYVINYLPYRROLIDONE HYDROXYPROGESTERONE CAPROATE DEHYROACETIC ACID & SODIUM DEHYDROACETATE MASTER FORMULA RECORDS ESTAZOLAM (TA-8) CHLORPROMAZINE HCL PRODUCTION FACILITY IN DETROIT, MICH. FLUOCORTIN BUTYLESTER (RECOMMENDED GENERIC NAME IS FLUOCORTIN BUTYL)

BEECHAM LABORATORIES DIV OF BEECHAM FACILITIES AND CONTROLS INC BOEHRINGER MANNHEIM GMBH DIHYDROXYPROPYLTHEOPHYLLINE (DYPHYLLINE) BOEHRINGER INGELHEIM KG SOCHINAZ SA MEDI PHYSICS INC SIGMA F AND D DIV LTD ABBOTT LABORATORIES DIHYDROERGOTOXINE METHANESULFONATE (DEMS) DIHYDROERGOTOXINE METHANE SULFONATE INDIUM III OXINE (DFORMERLY HELD BY DIAGNOSTIC ISOTOPES INC) ACETYL-BETA-METHYLCHOLINE CHLORIDE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MCPHERSON, KANSAS. ALLOPURINOL QUINIDINE SULFATE TRIMETHOPRIM AMFEPRAMON HCL (FORMERLY DIETHYLPROPION) PREDNISONE PIRACETAM (NOOTROPIL) SODIUM CARBOXYMETHYLDICELLULOSE GLYCEROL (CLD)

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4Q2012EXCEL DMF# 2877 2878 2879 2880 2881 2882 I 2883 2884 2885 I 2886 2887 2888 2889 2890 2891 2892 2893 2894 2895 I 2896 2897 2898 2899 2900 2901 I 2902 2903 2904 I 2905 2906 2907 2908 2909 2910 2911 2912 2913 I I I A I I A I I III III II II II I II II 3/22/1977 1/22/1973 4/28/1977 3/18/1977 4/29/1977 4/1/1977 4/12/1977 12/22/1976 10/26/1976 I I II II 4/19/1977 3/22/1977 4/13/1977 I I I I A II II II 4/6/1977 4/8/1977 4/14/1977 4/11/1977 4/6/1977 4/7/1977 PFANSTIEHL LABORATORIES INC BARNES HIND PHARMACEUTICALS INC GANES CHEMICALS INC SHIONOGI AND CO LTD SANOFI CHIMIE I I N I I I I I I I II II II II III 3/21/1977 3/18/1977 3/18/1977 3/8/1977 3/25/1977 2/17/1977 3/30/1977 IV II 3/25/1977 3/22/1977 I I II II 3/18/1977 3/24/1977 3/17/1977 MALLINCKRODT CHEMICAL INC ORGANON INC STATUS Type SUBMIT DATE I I I A I II I III II 3/2/1977 3/18/1977 3/3/1977 2/15/1977 3/1/1977 3/21/1977 HOLDER CILAG CHEMIE AG FRONTIER CONTACT LENSES INC APPLETON PAPER DIV NCR SUD CHEMIE PERFORMANCE PACKAGING CELANESE PLASTICS & SPECIALTIES CO LONZA RIVERSIDE SUBJECT ECONAZOLE NITRATE HYDRO-MARC (TM)(ETAFILCON A) SOFT CONTACT LENSES ASCOT HEAT SEAL STERILE PACKAGING TYPE 1A SORB-IT DESSICANT CANISTERS CRE 5G2-85D

4Q2012

PROCHLORPERAZINE, PROCHLORPERAZINE EDISYLATE,PROCHLORPERAZINE MALEATE NALBUPHINE HYDROCHLORIDE CODE 3300 MANUFACTURED IN ST. LOUIS, MISSOURI PREDNISONE

PLIVA PHARMACEUTICAL CHEMICAL FOOD & CHLORPROPAMIDE COSMETIC INDUSTRY SIGMA F AND D DIV LTD ALPHA-AMYLASE TYPE III-A SIEGFRIED AG NOT AN ASSIGNED NUMBER SCHERING AG LILLY RES LABS DIV ELI LILLY CO LILLY RES LABS DIV ELI LILLY CO HEINRICH MACK NACHF PARAMOUNT PACKAGING CORP EDWARD MENDELL CO INC PF LABORATORIES INC HYDROCORTISONE HEMISUCCINATE NORTRIPTYLINE HCL CAPSULES NORTRIPTYLINE HCL SOLUTION 5-FLUOROURACIL COEXTRUSION HIGH DEN. POLYETHYLENE W/ETHYLENE VINYL ACETATE COPOLYMER SODIUM GLYCINE CARBONATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. GLUCOSE POLYMER (G-130) BARNES-HIND SOLUTION FOR SOFT CONTACT LENSES DIMENHYDRINATE, BULK POWDER FORM SULFAMETHOXAZOLE N.F. HYDROCORTISONE HEMISUCCINATE N-ACETYL PROCAINAMIDE HCL

USV (PR) DEVELOPMENT CORP SUB RORER FACILS. & CONTROLS FOR AN ADDITIONAL MANUF FACILITY IN MANALI, P.R. GROUP SOCIETE CHIMIQUE POINTET GIRARD SA QUINIDINE SULFATE INDUSTRIA CHIMICA PROFARMACO SPA BENZBROMARONE BULK ABBOTT LABORATORIES PHARMACEUTICAL ERTHROMYCIN PHOSPHATE PRODUCTS DIV UNIPAC CORP CLOSURE LINER-CAP-SEAL II BRAND 3M PHARMS ETHYL CORP DIPHARMA FRANCIS SRL H REISMAN CORP DUPONT MERCK PHARMA BASF PHARMA EVIONNAZ SA ELI LILLY CO SYNTHETIC PRODUCTS CO CLOSURE LINERS ST-25 AND SW-25 ---CAP-SEAL BRAND IBUPROFEN---AS MANUF BY ETHYL CORP A THEIR FACIL. IN ORANGEBURG, S.C. AMITRIPTYLINE HCL BULK SODIUM SULFATHIAZOLE SESQUIHYDRATE & SODIUM SULFATHIAZOLE FACILITIES AND CONTROLS BUPIVACAINE HCL ZINC INSULIN CRYSTALS--ARGENTINA DMF-2912 SYNPRON 1375 PVC HEAT STABILIZER

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4Q2012EXCEL DMF# 2914 2915 I 2916 2917 2918 2919 2920 2921 2922 2923 2924 I 2925 2926 2927 2928 2929 2930 2931 2932 I 2933 2934 2935 2936 2937 2938 2939 2940 2941 2942 2943 2944 I 2945 2946 2947 2948 2949 2950 2951 I I I A I I I II IV II III I 5/9/1977 1/17/1977 5/13/1977 10/25/1976 5/11/1977 6/6/1977 5/26/1977 I I I I I A I I I I I II II II II II II II I II 4/26/1977 4/28/1977 5/9/1977 6/1/1977 5/2/1977 5/9/1977 5/11/1977 5/27/1977 4/22/1977 5/9/1977 5/12/1977 5/11/1977 KASAR LABORATORIES DIV KASAR CO MEMPHIS CHEMICAL CO PROCOS SPA AINC SYNCOR INTERNATIONAL INC PROCOS SPA BLASCHIM SPA SIEGFRIED AG JOHNS MANVILLE SALES CORP PROCOS SPA SIGMA F AND D DIV LTD N I I I I I I I II II V II 5/11/1977 5/3/1977 4/27/1977 5/13/1977 4/25/1977 5/18/1977 5/4/1977 A I I I I I A A II II III I III 5/2/1977 4/1/1977 4/1/1977 4/18/1977 4/18/1977 5/6/1977 5/2/1977 4/5/1977 3/28/1977 STATUS Type SUBMIT DATE I 9/14/1976 10/4/1976 HOLDER GLASROCK POREX DIV MICROBIOLOGICAL RESEARCH ESTABLISHMENT SUMITOMO BAKELITE CO LTD SAUFLON INTERNATL INC SAUFLON INTERNATL INC CLM SPECIAL POLYMERS LTD CLM SPECIAL POLYMERS LTD ER SQUIBB AND SONS INC SANOFI CHIMIE GEORGIA GULF CORP MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC NOT AN ASSIGNED NUMBER TEVA PHARMACEUTICAL INDUSTRIES LTD SIGMA F AND D DIV LTD THE CENTRAL PHARMACAL COMPANY ANTIBIOTICOS SPA DIOSYNTH BV ROUSSEL-UCLAF JANSSEN PHARMACEUTICA INC SUBJECT FACILITIES AND CONTROLS FOR T-17 ACHROMOBACTER GLUTAMINASE SUMILITE PRODUCTS SERIES SAUFLON PW SAUFLON 70 SAUFLON 70 POLYMER SAUFLON 85 POLYMER INSULIN 6-ALPHA-METHYLPREDNISOLONE HEMISUCCINATE PVC RESINS

4Q2012

FACILS., METHODS & CONTROLS FOR PROCESSING & PACKAGING OF DRUG PRODS.

STERILE MFG FACILITIES IN KVAR SAVA,ISRAEL DL-BETA-HYDROXYBUTYRIC ACID, SODIUM SALT STANDARD OPERATING PROCEDURES BOMBASIN CHENODEOXYCHOLIC ACID 25 HYDROXYCHOLECALCIFEROL (RU 4682) MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN BEERSE, BELGIUM. FACILITIES AND CONTROLS METHOXSALEN USP ISOPROPAMIDE IODIDE ZETA PLUS 12 NOMINAL DIAMETER CARTRIDGES FOR PHARMACEUTICAL USE FACILS. & CONTROLS PHENYLTOLOXAMINE CITRATE METHYLPREDNISOLONE ISOXSUPRINE HCL, NF XIV AS MANUF AND SOLD UNDER SIEGFRIED LABEL MEMBRA-FIL MEMBRANE FILTERS AND ASSOCIATED EQUIPMENT ORPHENADRINE HYROCHLORIDE & ORPHENADRINE CITRATE ETIOCHOLAAN-3 ALPHA-OL-17-ONE

NOBEL CHEMICALS AB DIV FINE CHEMICALS FLUOCINOLONE ACETONIDE INC BRANDYWINE COMPOUNDING CO OLEFINIC POLYMER BLEND BCC 5005H WERTHENSTEIN CHEMIE AG FARMITALIA SPA COLORCON INC GYMA LABORATORIES OF AMERICA INC BARVILLE CAOUTCHOUC MANUFACTURE SIGMA F AND D DIV LTD CHEMICAL PRODUCTION OPERATIONS DIHYDROERGOTOXINE MESYLATE LAKE, DYE, AND PIGMENT BLENDS TRIAMCINOLONE ACETONIDE PLURIBAR 30 L-AMINO-N-BUTYRIC ACID

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4Q2012EXCEL DMF# 2952 2953 2954 2955 I 2956 2957 2958 2959 2960 2961 2962 2963 I 2964 2965 2966 2967 2968 2969 2970 2971 2972 2973 2974 2975 2976 2977 2978 2979 2980 2981 2982 2983 2984 2985 2986 2987 2988 2989 2990 I I I I I I I I I I I I I I I I I A I I I I I I I I I II II I III II I II II II II I III II III II II II III 6/7/1977 6/29/1977 6/24/1977 7/12/1977 6/24/1977 6/27/1977 6/7/1977 6/27/1977 6/15/1977 7/1/1977 6/28/1977 7/12/1977 6/23/1977 6/10/1977 7/7/1977 7/11/1977 6/24/1977 7/27/1977 5/26/1977 7/8/1977 7/8/1977 7/19/1977 6/30/1977 7/6/1977 7/25/1977 7/20/1977 8/4/1977 I I I I I I I III II II IV IV V 6/21/1977 4/29/1977 5/24/1977 5/24/1977 4/25/1977 6/7/1977 6/6/1977 6/1/1977 STATUS Type SUBMIT DATE I I I II 6/10/1977 5/11/1977 6/16/1977 6/2/1977 HOLDER GANES CHEMICALS INC BLASCHIM SPA PARKE DAVIS & CO ENGLEHARD INDS DIV ENGLEHARD MINERALS & CHEMICALS GANES CHEMICALS INC STEPAN CHEMICAL COMPANY EMERY IND INC MALMSTROM CHEMICALS BOEHRINGER MANNHEIM GMBH NOVO NORDISK AS TAISHO PHARMACEUTICAL COMPANY LTD INTERNATIONAL FLAVORS AND FRAGRANCES INC KV PHARMACEUTICAL CO SB PENICK AND CO ORIG CROWN ZELLERBACH CORP PFANSTIEHL LABORATORIES INC ACIC LTD NATL INST HLTH CLINCL CTR PHARMACY KV PHARMACEUTICAL CO GANES CHEMICALS INC NAPP CHEMICALS INC SB PENICK AND CO ORIG PHARMACIA AND UPJOHN INC TREDEGAR MOLDED PRODS ACIC LTD NICE-PAK PRODUCTS INC COLORCON COMPANY NUCLEAR PHARMACY INC JOHNSON MATTHEY PLC BASF SE LAKE AND CRUICKSHANK MITSUBISHI CHEMICAL CORP HAARMANN & REIMER GMBH AIR PRODUCTS AND CHEMICALS INC RP SCHERER CORP ROBECO INC. CROCKER NUCLEAR LAB ASH STEVENS INC SUBJECT PHENYLEPHRINE HCL, USP XIX, BULK POWDER FORM METHYPREDNISOLONE ACETATE COVIDARABINE PLATINUM ON CARBON, SULFIDE AMINOPHYLLINE, USP XIX, BULK POWDER SURFA M-801G

4Q2012

TOXICITY STUDIES ON COSMETIC PRODUCTS: EYE & SKIN IRRITATION TEST,ETC. TOXICITY STUDIES ON LANOLIN ALCOHOLS AND LANOLIN ALCOHOL DERIVATIONS AMPOULE & VIAL PRODUCTION AT THE MANNHEIM FACILS GLUCAGON (BULK) CARBINOXAMINE MALEATE FLAVORINGS ACTIFED S.A. CAPS--PSEUDOEPHEDRINE HCL 120MG/TRIPROLIDINE DIPHENOXYLATE HYDROCHLORIDE USP BULK CROWN POLYPROPYLENE A-40 & A-63--SINGLE LAYER FILMS L-TRYTOPHAN PROPRANOLOL HCL USP XIX THYMIDINE (NSC21548) ACTIFED SUSTAINED RELEASE CAPSULES PHENTERMINE RESINATE DIOCTYL SODIUM SULFOSUCCINATE 45% IN POLYETHYLENE GYLCOL 400-55% DIPHENOXYLATE HYDROCHLORIDE USP WITH 1% AROPINE SULFATE USP BULK MANUFACTURING FACILITIES IN COLUMBUS, OHIO VISQUEEN 0-102 (MD-30) C-1 TREATED POLYETHYLENE SHEETING CLOFIBRATE B/P/USP/NF SPONGE AND SPONGE BRUSH PACKAGING OPACODE S-1-8100-HV, BLACK; OPACODE S-1-8215, GREY CENTRALIZED NUCLEAR PHARM FOR DISPENSING RADIOPHARM: 1. NA PERTECNETA WEST WHITELAND & DEVON PLANTS GLYCERINE-POLYETHYLENE GLYCOL-RICINOLEATE;MNFG&TESTED IN GERMANY D-PSEUDO EPHEDRINE ALKALOID, SULPHATE AND HYDROCHLORIDE NORETHINDRONE, BULK APRICOT FLAVOR 41 231 ARTIFICAL AND NATURAL 1. VINAC ASB 516 BEAD COPOLYMER (BEAD COPOLYMERS) PRODUCTION FACILITIES A MONROE, NORTH CAROLINA ROBANE (HYDROGENATED SQUALENE) RADIOCHEMICAL PREPARATIONS FACILITIES AND CONTROLS FOR THE CARLETON, MICHIGAN FACILITY

MITSUBISHI CHEMICAL INDUSTRIES LIMITED NORETHINDRONE ACETATE, BULK

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4Q2012EXCEL DMF# 2991 2992 2993 2994 2995 2996 2997 I 2998 I 2999 3000 3001 3002 I 3003 3004 3005 3006 3007 3008 3009 3010 3011 3012 3013 3014 3015 3016 3017 3018 3019 3020 3021 3022 I 3023 I 3024 3025 3026 3027 I I I I II I 9/23/1977 9/26/1977 9/19/1977 9/26/1977 I 8/17/1977 I I I I A A I I I I I I A I A A I I I II IV II II III III III II IV II II II II II IV II 8/12/1977 7/22/1977 8/5/1977 7/7/1977 8/8/1977 7/17/1977 8/1/1977 7/29/1977 8/24/1977 6/2/1976 7/29/1977 8/5/1977 8/24/1977 7/15/1977 7/22/1977 8/8/1977 3/24/1977 8/29/1977 9/16/1977 9/23/1977 ZENECA PHARMACEUTICALS ORGAMOL SA BOFORS AB LAB FOR COMPARATIVE BIOCHEMISTRY SYMRISE SIEGFRIED LTD PFANSTIEHL LABORATORIES INC ALZA CORP PLANTEX LTD CHEM AND PHARM WORKS EI DUPONT DE NEMOURS AND CO SIGMA F AND D DIV LTD BURDICK & JACKSON LABS,INC DMV FONTERRA EXCIPIENTS GMBH CO KG PYRION CHEMIE GMBH BASF CORP PARKER HANNIFIN CORP BASF AKTIENGESELLSCHAFT ALDEN OPTICAL LAB INC DIAMOND SHAMROCK CORP I I I IV III I 12/28/1977 7/21/1977 7/21/1977 7/20/1977 7/6/1977 CIBA GEIGY CORP PHARMACEUTICAL DIVISION 3M PHARMS SYNTEX USA INC BEECHAM INC BANNER PHARMACAPS INC ZINC PYRIDINETHIONE SCOTCHMARK LABEL STOCK SERIES;1)7000 2)7110 FACILITIES AND CONTROLS A SYNTEX IRELAND LTD. RAW MATERIALS SPECIF & TEST METHODS AT BEECHAM PHARM, U.K. DIV. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF SOFT GELATIN CAPS. CHLORHEXIDINE GLUCONATE 20% SOLUTION B.P. DIETHYLCARBAMAZINE CITRATE PENTAERYTHRITOL TETRANITRATE (PETN) ADENINE FOR USE IN HUMAN BLOOD PRESERVAIVE FORMULATION FLAVORINGS AMITRIPTYLINE HCL-MANUF & SOLD UNDER SIEGFRIED LABEL 14 AMINO ACIDS FOR USE IN PARENTERAL FEEDING ALZAMER CELLULOSIC RATE CONTROLLING MEMBRANE PRECURSORS CONJUGATED ESTROGENS, USP PERFLUOROCTYLBROMIDE CHOLINE CHLORIDE DYCLONINE HYDROCHLORIDE PRIMOGEL (NA STARCH GLYCOLATE) ZINC PYRION (ZINC PYRIDINTHIONE) POVIDONE-IODINE SEAL FORMULATIONS MANUFACTURED IN CULVER CITY, CALIFORNIA. LUPOLEN 1810 H RED 974 AL-47 POLYMER DUOLITE ARA-1157 AND DUOLITE ARA-2157 STATUS Type SUBMIT DATE I I I I I N 8/18/1977 II II II 8/17/1977 7/12/1977 7/18/1977 7/12/1977 7/22/1977 HOLDER SYNTEX USA INC DIOSYNTH BV DIOSYNTH BV DIOSYNTH BV GANES CHEMICALS INC NOT AN ASSIGNED NUMBER MONSANTO COMPANY SUBJECT CIMETIDINE ESTRADIOL CYPIONATE HYDROXYPROGESTERONE CAPROATE TESTOSTERONE CYPIONATE HEXOBARBITAL, NF XIV

4Q2012

POLYOLEFIN CONTAINERS MANUFACTURED BY PLAX CANADA LTD, BURLINGTON,ONT.

LEK LJUBLJANA PHARMACEUTICAL AND DIHYDROERGOTOXINE METHANESULFONATE (ERGOLOID MESYLATES) CHEMICAL CO ABBOTT LABORATORIES PHARMACEUTICAL FACILITIES PRODUCTS DIV ROURE BERTRAND DUPONT INC FRAGRANCE F 9819 SCHERING AG SIGMA F AND D DIV LTD ALDEN OPTICAL LAB INC QUINESTROL DL-5-FLUOROTRYPTOPHAN AL-47 SEMIFINISHED CONTACT LENS

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4Q2012EXCEL DMF# 3028 3029 3030 3031 3032 3033 3034 3035 3036 3037 3038 3039 3040 3041 3042 3043 3044 3045 3046 3047 3048 I 3049 3050 3051 3052 3053 3054 3055 3056 3057 3058 3059 3060 3061 3062 3063 3064 3065 3066 3067 I I I A I I I I I I I I A C I I I I I II II I II II II II II II II II I II II II 11/14/1977 11/9/1977 10/17/1977 10/18/1977 11/17/1977 11/17/1977 11/11/1977 11/1/1977 8/30/1977 11/21/1977 11/11/1977 11/22/1977 11/14/1977 11/9/1977 11/2/1977 11/4/1977 11/23/1977 10/13/1977 11/2/1977 PACO PACKAGING INC PCR INC SIGMA F AND D DIV LTD DIPHARMA FRANCIS SRL PFIZER INC HOFFMANN LA ROCHE INC DESMO CHEMICAL CORP GAELEO LTD DISCO LTD CYCLO PRODUCTS INC TANABE SEIYAKU CO LTD KYOWA HAKKO KOGYO CO LTD DUPONT NUTRITION BIOSCIENCES APS TEVA PHARMACEUTICAL INDUSTRIES LTD HOFFMANN LA ROCHE INC STAUFFER CHEM CO MILTON ROY CO KIMIA FARMA HOFFMANN LA ROCHE INC STATUS Type SUBMIT DATE I I I I I I I I I I I I I I I I I I I I II II IV V II I II III III IV II II II II II I 8/30/1977 10/22/1977 9/6/1977 9/9/1977 9/20/1977 9/15/1977 9/21/1977 8/30/1977 9/26/1977 10/13/1977 10/12/1977 10/10/1977 10/24/1977 10/24/1977 10/24/1977 10/21/1977 9/29/1977 11/8/1977 11/7/1977 11/8/1977 10/25/1977 HOLDER SIEGFRIED AG SIGMA F AND D DIV LTD CONTINUOUS CURVE GANES CHEMICALS INC N&N MENICON INC PLANTEX LTD CHEM AND PHARM WORKS EQUISTAR CHEMICALS LP BORG-WARNER CHEMICALS SYMRISE INC TEIKOKU CHEM INDUSTRY IVAX PHARMACEUTICALS SRO LOFTUS BRYAN CHEMICALS LTD CORD LABORATORIES INC PLANTEX LTD CHEM AND PHARM WORKS SSL INTERNATIONAL SIGMA F AND D DIV LTD GELMAN SCIENCES INC WM LEMAN INC HENKEL KGAA MONSANTO RES CORP DIV MONSANTO CO DINAMITE DIPHARMA SPA SUBJECT ISOXSUPRINE HYDROCHLORIDE, NF XIV L-PHOSPHATIDYL CHOLINE TYPE IX-E MFG AND CONTROL (HYDROCURVE PATIENT DISINFECTION UNIT)

4Q2012

SODIUM P-AMINOBENZOATE-POTASSIUM P-AMINOBENZOATE-P-AMINOBENZOIC ACID SOFT CONTACT LENS FUROSEMIDE USP POLYETHYLENE RESINS CYCOLAC CIT 31336 AND CYCOLAC X-11-2783 F FLAVORINGS HYDROXYZINE HCL ERGOTAMINE TARTRATE PROMETHAZINE HCL THEOPHYLLINE CAP TOLNAFTATE LISTING OF PRECLINICAL TOXICOLOGY STUDIES (CHLORHEXIDINE GLUCONATE 20%) GLUTAHIONE OXIDIZED ACROFLOW 121 AND PREFLOW N.F.R. FILTER CARTRIDGE LINES NATURAL PEPPERMINT OIL NOVAA R SUPPOSITORY BASES METHOTREXATE D-PROPOXYPHENE NAPSYLATE MANUFACTURED IN THE BARANZATE DI BOLLATE (MILAN), ITALY FACILITIES LAKEWOOD FACILITY FOR DRUG PACKAGING FACILITIES AND CONTROLS FOR THE HUMACAO, PUERTO RICO PLANT L-ALPHA-PHOSPHATIDYL CHOLINE TYPE II-S SPIRONOLACTONE AS MG IN MILAN TESTOLACTONE, USP BIOTIN BENBROMARONE AS MANUF BYRSA. CORP, ARDLEY, N.Y. METHODS, FACILITIES AND CONTROLS MICRO-ENEMA CHLORPROMAZINE HCL U.S.P. DILTIAZEM HCL L-DOPAMINE HYDROCHLORIDE (3-HYDROXYTYRAMINE HYDROCHLORIDE ) VALPROIC ACID (ESUB) 5-FLUOROURACIL AS MANUF IN HUMACAO, PUERTO RICO URSODEOXYCHOLIC ACID (RO13-1798) EMCOMPRESS (DICALCIUM PHOSPHATE DIHYDRATE) PHP (HEFILCONA) SOFT CONTACT LENS BUTTONS QUINIDINE SALTS CHENODEOXYCHOLIC ACID TABLETS, 250MG (R08-2871)

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4Q2012EXCEL DMF# 3068 3069 I 3070 3071 3072 3073 3074 3075 3076 I 3077 3078 3079 3080 3081 3082 A 3083 3084 3085 3086 I 3087 3088 3089 3090 3091 3092 3093 3094 3095 3096 3097 3098 3099 3100 3101 3102 3103 3104 3105 I I I I I I I I I I I I I I I I I I I II II II II II II I II 11/22/1977 12/9/1977 12/9/1977 12/15/1977 12/12/1977 11/21/1977 11/21/1977 12/14/1977 12/14/1977 12/15/1977 1/9/1978 1/9/1978 1/3/1978 1/3/1978 12/16/1977 1/13/1977 1/13/1977 12/27/1977 1/3/1978 I I I II II 11/28/1977 11/15/1977 11/21/1977 12/5/1977 I I I I I II I III 12/6/1977 12/6/1977 12/6/1977 11/29/1977 12/8/1977 11/14/1977 I I I I I I II I II 11/23/1977 10/6/1977 11/9/1977 11/8/1977 11/17/1977 11/21/1977 11/15/1977 STATUS Type SUBMIT DATE I II 11/9/1977 10/31/1977 HOLDER PHARMA-WALDHOF GMBH ROHM CHEMICAL LABORATORY COMPANY LTD OLC LABORATORIES INC STANDARD PHARMACAL CORP ROUSSEL-UCLAF NYEGAARD AND CO AS SIGMA F AND D DIV LTD SIEGFRIED AG SUBJECT GLUTAHIONE REDUCED (GSH)

4Q2012

MANUF PROCESSES OF CAP-PLATE MENICON & MAFILCON SOFT CONTACT LENS MA. STANDARD OPERATING PROCEDURES FOR DISTRIBUTING L-TRYPTOPHAN PRODUCT SPECIFICATIONS ESTRADIOL VALERATE METRIZAMIDE (AMIPAQUE) 5,5-DIPHENYLHYDANTOIN DIBENZOSUBERONE AS MANUF & SOLD UNDER SIEGFRIED LABEL

THE WEST CO PLASTIC CONTAINER DIV SUB FACILS & CONTRLS-PLEASANTVILLE, NJ (THIS DFORMERLY CITATION PLASTIC OF THE WEST COMPANY CYCLO PRODUCTS INC TRIFLUORPERAZINE HCL NF CYCLO PRODUCTS INC CYCLO PRODUCTS INC RHONE-POULENC WEST PHARMACEUTICAL SERVICES INC WEBER INTERNATIONAL PACKAGING CO LLC AS SYNTHETICS STANDARD PASTE & GLUE COMPANY INC INDENA GRUPPO INVERNI DELLA BEFFA LAOB LABORATORIO OPOTERAPICO BRASILEIRO SA PLANTEX LTD CHEM AND PHARM WORKS GENEVA GENERICS TUTAG PHARMS GRAVURE FLEX CORPORATION GANES CHEMICALS INC LONGVIEW FIBRE CO MASCHEMIJER AROMATICS INC SHAWANO PAPER MILLS INC NORTHWESTERN CHEMICAL CO ARLIN MANUFACTURING COMPANY INC ANTIBIOTICOS SPA SYNTEX OPHTHALMICS INC ANTIBIOTICOS SPA ANTIBIOTICOS SPA AM TODD CO SYNTEX USA INC GRUPPO LEPETIT SPA ANTIBIOTICOS SPA ANTIBIOTICOS SPA PROCHLORPERAZINE MALEATE U.S.P. IMIPRAMINE HCL U.S.P. TRIFLUOPERAZINE CHLORHYDRATE OAK STREET LIQUID DRUG PRODUCTION, LAKEWOOD, NEW JERSEY PLASTIC BOTTLES MANUFACTURED IN PLATTSBURGH, NY SULFAMETHIZOLE N.F. XIV ADHESIVE FORMULATION-S-200-K-1-B CASANTHRANOL(THIS DFORMERLY HELD BY INVERNI DELLA BEFFA, ITALY) SODIUM HEPARIN USP TOLNAFTATE U.S.P. FACILITIES AND STANDARD OPERATING PROCEDURES FACILITIES AND STANDARD OPERATING PROCEDURES FACILITIES & CONTROLS--SPECIALITY LAMINATIONS DIBENZOSUBERONE BULK FORM PACKAGING MATERIALS FRAGRANCES GRADE NO. 181-1-165-3 WHITE MG FOIL MOUNTING TISSUE GLYCEROL MONOSTEARATE TEAR TAPES HYDROCORTISONE 21-HYDROGEN, SUCCINATE, BULK, NON-STERILE CONTACT LENSES ENDRYSONE (BULK, NON-STERILE, NON-MICRONIZED & MICRONIZED) DESONIDE, BULK, NON-STERILE, NON-MICRONIZED & MICRONIZED NATURAL OILS-PEPPERMINT & SPEARMINT FRACTIONATED (REDISTILLED) SILAFOCON A L-ALANOSINE MEDRYSONE USP XIX, NON-MICRONIZED AND MICRONIZED BETAMETHASONE 17-VALERATE, NF BULK, NON STERILE, NON MICRON & MICRON

Page 84

4Q2012EXCEL DMF# 3106 3107 3108 3109 3110 3111 3112 3113 3114 3115 3116 3117 3118 3119 3120 3121 3122 I 3123 3124 I 3125 3126 3127 3128 I 3129 3130 3131 3132 3133 3134 3135 3136 3137 3138 3139 3140 3141 3142 I 3143 I 2/20/1978 I I A I I I I A I I A I I II III I II II II II II II II 1/20/1978 1/20/1978 2/27/1978 1/8/1978 12/21/1977 1/24/1978 12/15/1977 1/23/1978 1/24/1978 2/21/1978 2/28/1978 2/9/1978 1/4/1978 2/1/1978 I I A II I IV I 1/20/1978 1/24/1978 2/16/1978 1/5/1978 I II II 1/24/1978 2/3/1978 MALLINCKRODT CHEMICAL INC LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO ISOCHEM SA TRIO PRODUCTS INC SHIN ETSU CHEMICAL CO LTD AMERSHAM CORP SUB RADIOCHEMICAL CENTER KV PHARMACEUTICAL CO KV PHARMACEUTICAL CO KYOWA HAKKO BIO CO LTD PLANTEX LTD CHEM AND PHARM WORKS DR ROSE INC CIECH POLFA KV PHARMACEUTICAL CO FIS FABBRICA ITALIANA SINTETICI SPA WARD BLENKINSOP AND CO LTD SIGMA F AND D DIV LTD DIPHARMA FRANCIS SRL AMERICAN NATIONAL CAN CO BOEHRINGER MANNHEIM GMBH RHONE POULENC PHARMACEUTICALS RP INC PFANSTIEHL LABORATORIES INC DIOCTYL SODIUM SULFOSUCCINATE IN P E G AS MANUF. IN RALEIGH, N.C. STATUS Type SUBMIT DATE I I I I I I I I I I A I I I I I II III II II IV III IV II II II II II II 1/6/1978 12/27/1977 1/16/1978 12/27/1977 12/27/1977 1/18/1977 1/3/1978 11/18/1977 12/22/1977 1/11/1978 12/27/1977 1/6/1978 11/17/1977 12/30/1977 12/15/1977 1/26/1978 12/19/1977 HOLDER E MERCK ANTIBIOTICOS SPA ANTIBIOTICOS SPA ANTIBIOTICOS SPA KNOLL AG LUDWIGSHAFEN ALDEN OPTICAL LAB INC ANTIBIOTICOS SPA COLORPLAST LTD CORNING GLASS WORKS NAARDEN UOP FRANGANCES BASF PHARMACHEMIKALIEN GMBH CO KG TOKYO KASEI KOGYO CO LTD SHIONOGI AND CO LTD HOUBA INC LA DREYFUS CO MERCK SHARP & DOHME LTD EASTMAN CHEMICAL CO SUBJECT DIOCTYL SODIUM SULFOSUCCINATE (45% SOLUTION) PREDNACINOLONE ALCOHOL, MICRONIZED & NON MICRONIZED FLUROMETHOLONE-(BULK, NON-MICRONZIED & MICRONIZED) 6-ALPHA-METHYLPREDNISOLONE-21-HYDROGEN SUCCINATE HYDROXYZINE HYDROCHIORIDE AL-47 CONTACT LENS FLUOCINONIDE (BULK, NON STERILE, NON-MICRONIZED & MICRONIZED) PLASKO WHITE 80-F PHARMACUETICAL ROLLER BOTTLES-PRODUCT NO.25140 LADINA FRAGANCES RO 57.836 DOPAMINE HYDROCHLORIDE

4Q2012

A,A,-AZOBIS(ISOBUTYRONITRILE)FOR N&N MENICON(MAFILCON)SFT CONTACT MA. KEFLEX R SUSTAINED RELEASE CAPSULES (CEPHALEXIN MONOHYDRATE LILLY) METHODS, FACILITIES AND CONTROLS FRO D-BIOTIN SOFT IDEAL R BUBBLE GUM BASE AND NT CHEWING GUM BASE PREPARATION OF TEN STABLE ISOTOPE-LABELLED COMPOUNDS ETHYLENE METHYL ACRYLATE COPOLYMERS (EMAC) MANUFACTURED IN LONGVIEW TX

FACILS & CONTROLS FOR LEDERLE METHOTREXATE, INC. & LEDERLE PARENTERALS QUINIDINE PRODUCTS FACILITIES AND CONTROLS LOW SUBSTITUTED HYDROXYPYLCELLULOSE (L-HPC) FACILS, CONTROLS & PERSONNEL-A THE FREEZE DRYING UNIT GLOUCESTER ENG ELIXOPHYLLIN SUSTAINED RELEASE CAPSULES 125MG (THEOPHYLLINE) ELIXOPHYLLIN SUSTAINED RELEASE CAPSULES 250MG. (THEOPHYLLINE) MANUFACTURING AND QUALITY INFORMATION ON BULK DRUG SUBSTANCES ESTERIFIED ESTROGENS, U.S.P. FACILS, CONTROL & MANUF OF GLYCERINE SUPPOSITORIES FUROSEMIDE PHENDIMETRAZINE TARTRATE SUSTAINED RELEASE CAPSULES 100 MG. INDOMETHACIN, USP LIDOCAINE (LIGNOCAINE) L-CARNITINE TOLBUTAMIDE PAPER-FOIL-POLYETHYLENE LAMINATE FILM-MANUF AT MT. VERNON OH FACILITY TABLETTING AND ENCAPSULAING FACILITIES ACETAMINOPHEN (BULK) AS MANUFACTURED AT THE BARTON PLANT IN LULING, LA L-GLUCOSE, C.P., CATALOG NO. G-117

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4Q2012EXCEL DMF# 3144 I 3145 3146 3147 3148 3149 3150 I 3151 3152 I 3153 3154 3155 I 3156 3157 3158 3159 I 3160 3161 3162 3163 3164 3165 3166 3167 3168 3169 3170 3171 3172 3173 3174 3175 3176 3177 3178 I 3179 I III 3/13/1978 I I I I A I I I I I I I I I I I I I II II I II II II II II 3/21/1978 2/27/1978 2/28/1978 2/28/1978 2/28/1978 2/22/1978 2/8/1978 2/27/1978 2/28/1978 3/6/1978 2/8/1978 3/20/1978 3/23/1978 3/23/1978 3/24/1978 3/16/1978 4/4/1978 4/4/1978 4/11/1978 I I I II II II 3/21/1978 2/24/1978 2/28/1978 1/31/1978 I I II I 2/14/1978 2/27/1978 3/27/1978 EKCO PRODUCTS INC HEINRICH MACK NACHF I I 3/3/1978 2/24/1978 I I I I A II II II II II 2/28/1978 3/10/1978 2/8/1978 3/15/1978 3/15/1978 3/16/1978 STATUS Type SUBMIT DATE II 2/28/1978 HOLDER INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA DR REDDYS LABORATORIES LTD PRB CHEMIE ISTITUTO CHEMICOTHERAPICO ITALIANO MASS INSTITUTE OF TECHNOLOGY KYOWA HAKKO BIO CO LTD CORD LABORATORIES INC DIV SJ TUTAG AND CO AKTIEBOLAGET LEO ANDERSON PACKAGING INC SUBJECT SULFAMETHOXAZOLE

4Q2012

FLUNISOLIDE AS MANUF AT THE GRAND BAHAMA AND GUERNAVACA FACILITIES QUINIDINE SULPHATE USP 19 TRIMETHOPRIM BULK, BP 1973 FACILITIES AND CONTROLS AMINO ACIDS MANUFACTURED IN HOFU, YAMAGUCHI, JAPAN. THEOPHYLLINE CAPSULES, T.D. METHODS, FACILITIES AND CONTROLS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES DRAWN ALUMINUM UNIT DOSE CONTAINERS THYMIDINE

ABBOTT LABORATORIES PHARMACEUTICAL FACILS., PROCEDS., & CONTROLS-A THE BARCELONETA, PUERTO RICO PLANT PRODUCTS DIV CHEMIE GRUNENTHAL GMBH SUPIDIMIDE (FACILITIES AND CONTROLS) (CG 3033) ERCOPHARM HENKEL INC INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA CHEMIE GRUNENTHAL GMBH PLANTEX USA INC DIV IKAPHARM INC KV PHARMACEUTICAL CO KV PHARMACEUTICAL CO FIS FABBRICA ITALIANA SINTETICI SPA SYNTHA CILAG CHEMIE AG MACH ENTERPRISES ALZA CORP SANOFI CHIMIE CILAG CHEMIE AG CADALLAC PACKAGING INC SYNTEX USA INC ARNAR-STONE LABS INC SYNTEX USA INC LYNE LABORATORIES INC LEON INDUSTRIES INC SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP BAYER CORP L-ALPHA METHYLDOPA STANDAPOL SH-135 SPEC. DIPHENHYDRAMINE HCL & DIMENHYDRINATE SUPIDIMIDE(CG 3033) PRECLINICAL & CLINICAL STUDIES OUTSIDE THE U.S. SULFAMETHOXAZOLE, N.F. THEOPHYLLINE SUSTAINED RELEASE CAPSULES, 125 MG. THEOPHYLLINE S.R. CAPSULES, 250 MG. DIAZEPAM USP XIX DOPAMIN HCL ACETRIZOIC ACID SODIUM HEPARIN FACILITIES OF ALZA MEXICANA S.A. -ESTADO DE MEXICO DIHYDROERGOTOXIN MESYLATE 3-AMINOPROPIONITRILE FUMARATE FACILITIES, PROCEDURES AND CONTROLS CIPROCINONIDE-MANUF BY SYNTEX RES IN CA, BAHAMAS CHEM DIV SYNTEX SVP FACILITY AT ARNAR-STONE LABS,INC-MOUNT PROSPECT, ILL PROCINONIDE AS MANUF BY SYNTEX RESEARCH IN CA, BAHAMAS CHEMICAL DIV. PROCEDURES, FACILITIES AND CONTROLS PROCEDURES, FACILITIES AND CONTROLS (FORT LAUDERDALE, FLA) TICRYNAFEN (DOMESTIC PRODUCTION) THE COMPLETE BUTYL PRODUCT LINE MANUF BY POLYSAR BELGIUM N.V.

MITSUBISHI CHEMICAL INDUSTRIES LIMITED ESTRADIOL

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4Q2012EXCEL DMF# 3180 3181 3182 I 3183 3184 3185 3186 3187 3188 3189 3190 3191 3192 3193 3194 3195 3196 3197 3198 3199 3200 3201 I 3202 3203 3204 3205 3206 3207 3208 3209 A 3210 3211 3212 3213 3214 3215 3216 3217 3218 I I I I I I I I I II IV I V II 4/11/1978 5/23/1978 5/1/1978 4/12/1978 5/17/1978 5/5/1978 6/7/1978 6/23/1978 6/2/1978 I I I I I I A II II II I I III 5/19/1978 3/17/1978 3/8/1978 4/19/1978 4/13/1978 4/28/1978 5/25/1978 4/17/1978 ALUMINUM COMPANY OF AMERICA PFANSTIEHL LABORATORIES INC GLASFLEX G AND W LABORATORIES INC ALUMINUM COMPANY OF AMERICA HEINRICH MACK NACHF DR REDDYS LABORATORIES LTD SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL FARMITALIA SPA SYNTEX USA INC AAA LABORATORY CONWAY CHEMICAL CO LTD PCR INC SIGMA F AND D DIV LTD ROUSSEL CORPORATION JANSSEN PHARMACEUTICA NV TOWA PHARMACEUTICAL CO LTD ALUMINUM CLOSURES W/COMPOSITE LINER - MFG.RICHMOND, INDIANA SODIUM GLUCOHEPTONATE, NRC GRADE, CATOLOG NO. S-105 FACILITIES AND CONTROLS FOR CONTACT LENS MATERIALS MFG FACILS & CONTROLS FOR G&W LABS,INC., SO. PLAINFIELD, NJ I I I I I I I A I I I I I I I I I I V II IV II IV III II II II II IV 3/31/1978 4/14/1978 3/9/1978 4/6/1978 4/7/1978 4/28/1978 4/28/1978 4/28/1978 4/19/1978 3/20/1978 4/5/1978 2/27/1978 4/21/1978 5/17/1978 5/10/1978 5/11/1978 4/25/1978 4/21/1978 5/11/1978 STATUS Type SUBMIT DATE N I I 4/21/1978 4/11/1978 HOLDER NOT AN ASSIGNED NUMBER PHARMAKINETICS LABORATORIES INC PENN CHEMICALS BV SUB SK BECKMAN CORP REITECH CORP FERRO PFANSTIEHL INC RHONE-POULENC SANTE HOECHST AG SIEGFRIED AG SIGMA F AND D DIV LTD PFANSTIEHL LABORATORIES INC PHARMACIA AND UPJOHN SUB PFIZER INC IMPERIAL CHEMICAL INDUSTRIES PLC TAKASAGO PERFUMERY CO LTD WYETH INC H REISMAN CORP AQUALON CO PHARMACIA AND UPJOHN INC ICI AMERICAS INC ROUSSEL-UCLAF TAKASAGO PERFUMERY CO LTD AMERICAN NATIONAL CAN CO ANTIBIOTICOS SPA FACILITIES AND PROCEDURES (ADMINISTRAIVE AND OPERATING) TICRYNAFEN (AS PRODUCED A THE CORK, IRELAND FACILITY) ROFLEX P INK SERIES EGG PHOSPHATIDE PERCHLORPERAZINE BIS-MALEATE ACID OCTOPIROX FLUORESCEIN SODIUM, U.S.P. XIX METHYLENE DIPHOSPHORIC ACID METHOTREXATE TESTOSTERONE, USP POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE FLAVORS, FACILITIES AND CONTROLS FOR THE LOCATION IN JAPAN TEMAZEPAM SODIUM SULFAMETHAZINE TOXICOLOGICAL STUDIES OF NAROSOL HYDROXYETHYL CELLULOSE 17A-METHYLTESTOSTERONE TWEEN 80 (POLYSORBATE 80) DELTADIIODOMEDRANE MILK FLAVOR ON-1366 SUBJECT

4Q2012

RETORT. PHARMACEU. PKGS-IN MT. VERNON, OH. (CONTINENTAL CAN CO -ORIG) 17A-HYDROXYPROGESTERONE CAPROATE USP, BULK, NON-STERILE,NON-MICRONIZED

PHAR 9012 (PAPER MOUNTED LAMINATION OF ALUM. FOIL & POLYOLEFIN-IN IOWA CARBINOXAMINE MALEATE NAPROXEN SODIUM-AT BAHAMAS CHEM DIV., SYNTEX S.A. & SYNTEX IRELAND,LTD DIPYRIDAMOLE ERGOTAMINE TARTRATE USP VALPROIC ACID PROCEDURES FOR AMINO ACID ANALYSIS BETHANECHOL CHL N.F. 5-TRIFLUOROMETHYL-2-DEOXYURIDINE 17 ALPHA-ESTRADIOL HUMAN CHORIONIC GONADOTROPIN AS REC'D FROM COHELFRED FACILS. & CONTROLS FOR PRODUCTION UNIT II AT GEEL, BELGIUM GASTROLUFT TABLETS

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4Q2012EXCEL DMF# 3219 3220 3221 3222 3223 3224 3225 3226 3227 3228 3229 3230 3231 3232 3233 3234 3235 A 3236 3237 3238 3239 3240 3241 3242 3243 3244 I 3245 3246 3247 3248 3249 3250 3251 3252 3253 3254 3255 3256 3257 I I I I I I I I I I I I I II I II II II 1/16/1978 6/16/1978 7/14/1978 4/11/1978 7/19/1978 6/2/1978 5/29/1978 7/14/1978 6/28/1978 6/23/1978 6/27/1978 7/14/1978 7/21/1978 I I I I A I I I III II II II II II II II 6/14/1978 6/5/1978 6/27/1978 7/18/1978 6/30/1978 6/28/1978 6/30/1978 6/22/1978 7/6/1978 STATUS Type SUBMIT DATE I I I I I I I I I I I A I I I I II I III IV II II II II II II 5/26/1978 6/14/1978 6/6/1978 5/23/1978 6/16/1978 6/15/1978 5/25/1978 6/22/1978 9/27/1978 5/31/1978 5/28/1978 5/26/1978 7/10/1978 6/2/1978 6/26/1978 6/28/1978 6/22/1978 HOLDER DM GRAHAM LABORATORIES INC ROUSSEL-UCLAF PARCOR SA FARMITALIA SPA KYOWA HAKKO KOGYO CO LTD SIGMA F AND D DIV LTD ORMA ISTITUDO TERAPEUTICO KOLMAR LABORATORIES INC 3M PHARMS ICI LTD ORMA ISTITUDO TERAPEUTICO TEVA PHARMACEUTICAL INDUSTRIES LTD DIAMOND SHAMROCK CORP PACKAGING INK CORP SIGMA F AND D DIV LTD ACF CHEMIEFARMA NV CYTEC INDUSTRIES BUSINESS UNIT AMERICAN CYANAMID CO LEMMON CO LEO PHARMACEUTICAL PRODUCTS LTD FRANK B ROSS COMPANY INC SK&F LAB CO SUB SK BECKMAN CORP ROCHE PALO ALTO LLC DSM MINERA BV SIGMA F AND D DIV LTD PLANTEX LTD CHEM AND PHARM WORKS CYTEC INDUSTRIES BUSINESS UNIT AMERICAN CYANAMID CO DIOSYNTH BV MALLINCKRODT INC KV PHARMACEUTICAL CO SCHARPER SPA MEDIMPEX NORTHAMERICA INC HOWMEDICA INC LABAZ LABORATORIES KV PHARMACEUTICAL CO BERK PHARMACEUTICALS LTD REXHAM CORP REHEIS CHEM CO DIV ARMOUR AND CO SIGMA F AND D DIV LTD INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA SUBJECT

4Q2012

PROBANTHINE (P.A.) FACILS&CONTRL FOR PREPAR. & PACKAG.-FIN. DOS. FORM TESTOSTERONE CYPIONATE FACILITIES AND CONTROLS CYANOCOBALAMIN (VITAMIN B 12) AMINO ACID BLEND KYOWA,TYPE TR-1 DIETHYLENETRIAMINE PENTACETIC ACID TRISODIUM ZINC SALT, 0.5 MOLAR SOL. NANDROLONE PHENYLPROPIONATE FACILITIES AND CONTROLS AT THE DENTON, TX LOCATION AEROSOL VALVES VICTREX (TM) POLYETHERSULFONO RESIN NANDROLONE DECANOATE DOXEPIN HCL B.P. TREAMENT OF HYDROPHILIC SOFT CONTACT LENSES FLEXO CELLOPHANE BLACK INK -FBK-7828 5-HYDROXYTRYPTAMINE CREAININE SULFATE COMPLEX MANUFACTURING FACILITIES DIOCTYL ESTERS OF SULFOSUCCINIC ACID (NA, CA, K, SALTS)BOUND BROOKS NJ CHENODEOXYCHOLIC ACID CAPSULES, 250MG MECILLINAM FOR INJECTION ROSS CARNAUBA WAX,POWDERED, REFINED # 80(NATURAL & SYNTHETIC WAXES) CIMETIDINE AND CIMETIDINE HCL-MANUF A THE GUAYAMA, PUERTO RICO FACILS RS-37619-00-31-3 (RS-37619, TROMETHAMINE SALT) QUINIDINE GLUCONATE USP XIX GLYCINE METHYLDOPA USP SULFA DRUGS & MISC. SULFA PRODS AS MANUF AT BOUND BROOK, N.J. NORANDROSTENEDIONE --NANDROLONE DIOCYTL SODIUM SULFOSUCCINATE IN POLYETHYLENE GLYSOL 400 MFG ST.LOUIS THEOPHYLLINE S.R. CAPSULES 125MG ALGLUTAMOL SULFADIMIDINE/SUPERSEPTYL (R) FACILITIES, METHODS & CONTROLS FOR THE DEKNATEL DIVISION PERSONNEL, METHODS, FACILITIES AND CONTROLS THEOPHILLINE S.R. CAPSULES 250MG MANUFACTURING & PACKAGING OF 1-TRYPTOPHAN (PACITRON TABLESTS, 500MG) PACKAGING CONSTRUCTIONS MANUF A MEMPHIS, TENN FACILITY ALIMINUM ZIRCONIUM CHLORHYDRATES CONTAINING MAGNESIUM SALTS PROGESTERONE PERSONNEL, FACILITIES AND CONTROLS(GENERAL OPERATING PROCEDURES)

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4Q2012EXCEL DMF# 3258 3259 3260 3261 3262 3263 3264 3265 3266 3267 3268 3269 3270 3271 3272 3273 I 3274 3275 3276 3277 3278 3279 3280 3281 3282 I 3283 3284 3285 3286 3287 3288 3289 3290 3291 3292 3293 3294 3295 3296 I I I I I I I I A I A I I I II II II II IV II II 7/24/1978 7/18/1978 8/29/1978 9/13/1978 8/7/1978 8/17/1978 8/8/1978 6/27/1978 9/15/1978 9/15/1978 9/13/1978 9/15/1978 8/2/1978 9/5/1978 I I I I I I I I II II II II 7/31/1978 8/15/1978 6/20/1978 4/11/1978 8/30/1978 6/6/1978 8/10/1978 6/21/1978 9/11/1978 STATUS Type SUBMIT DATE I I I I I I I I I I I I I I I I II I II II II II I II III I 8/9/1978 7/5/1978 8/9/1978 7/10/1978 5/25/1978 6/13/1978 7/14/1978 4/11/1978 7/21/1978 8/4/1978 6/9/1978 8/9/1978 8/21/1978 8/11/1978 6/2/1978 7/21/1978 HOLDER BARNES HIND PHARMACEUTICALS INC ANCHOR HOCKING CORP WARD BLENKINSOP AND CO LTD DOW CHEMICAL CO MICHIGAN DIV HATCO CHEMICAL CORP UNION CARBIDE CORPORATION STEROID SRL SCHARPER SPA SIGMA F AND D DIV LTD BUCKEYE CELLULOSE CORP BARDAHL CHICAGO INC PROSINTEX SPA MEDIMPEX NORTHAMERICA INC ORION CORP FERMION OY ORION CORPORATION FERMION OULU PLANT SIGMA F AND D DIV LTD UNION CARBIDE CORPORATION PHARMA-WALDHOF GMBH SCHARPER SPA SIGMA F AND D DIV LTD ACE LUBE OIL CO NATL INST HLTH NCI FISKE BROTHERS REFINING CO FUJISAWA PHARMACEUTICAL COMPANY LTD SIGMA F AND D DIV LTD SIEGFRIED AG ALPHA ONE BIOMEDICALS INC SIFAVITOR SRL BASF AKTIENGESELLSCHAFT COMATIC LABORATORIES INC SIGMA F AND D DIV LTD ORION CORP LTD SIFAVITOR SRL SIFAVITOR SRL SIFAVITOR SRL SIFAVITOR SRL SIGMA F AND D DIV LTD WERNER G SMITH INC SUBJECT

4Q2012

MFG. CONTROLS & DISTR. OF STERILE AND NON STERILE PROD.(TRANS-DEVICES) COMPONENT, PROCESS & MANUF DATA FOR PLASTIC CONTAINERS PROBENECID VERSENE CA. CALCIUM CHELAING AGENT HATCOL 200 20% OXYGEN, 80% ARGON AS MANUF A TORRENCIE, CA DICHLORPHENAMIDE (1,2 DICHLOR 3,5 DISULPHONAMIDO BENZENE) FUROSEMIDE PERSONNEL, FACILITIES AND CONTROLS PRODUCT CLD-2 FOOD MACHINERY GREASE PERSONNEL, FACILITIES AND CONTROLS TOLBUTAMIDE USP XIX GENERAL METHODS, FACILITIES, AND CONTROLS CYCLOPHOSPHAMIDE ORAL GRADE PERPHENAZINE CAABATE, SODIUM OXYBATE, GAMMA-HYDROXYBUTYRIC ACID, SODIUM SALT 20% OXYGEN, 80% ARGON AS MANUF A THE EAST CHICAGO THYMIDINE TRIAMTERENE THYMIDINE LUBRICANTS: 1. ALUMPLEX FM 2-EP DON (NORLEUCINE, 6-DIAZO-5-OXO-,L). OIL AND GREASESLUBRIPLATE (TIARAMIDE HCL) GENERAL PROCEDURES L-ALANINE BISACODYL, U.S.P. XIX SYNTHETIC THYMOSIN (RO 21-9199) FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES KOLLIDON 12 PF, POLYVINYLPYRROLIDONE FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES L-GLUTAMIC ACID MONO SODIUM SALT CHLORHEXIDINE GLUCONATE SOLUTION BP 20% NORTRIPTYLINE HCL, USP CYCLANDELATE CYPROHEPTADINE, USP CHLOROTRIANISENE N.F. XIV L-GLUTAMIC ACID ESTERFIED FATY ACIDS & FATY ALCOHOL: 1.W.G.S. SYNACETI 116 NG/USP

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4Q2012EXCEL DMF# 3297 3298 3299 3300 3301 3302 3303 3304 3305 3306 3307 3308 3309 I 3310 3311 3312 3313 3314 3315 3316 3317 3318 3319 3320 I 3321 3322 3323 3324 3325 3326 I 3327 3328 3329 3330 3331 I 3332 3333 3334 I I I II II II 10/3/1978 7/12/1978 7/4/1978 A A I I III II II IV II 10/2/1978 6/14/1978 7/13/1978 9/14/1978 10/20/1978 AMERICAS STYRENICS LLC ACRAF SPA SUMIKA FINE CHEMICALS CO LTD M AND T CHEMS INC CHINOIN PHARMACEUTCAL AND CHEMICAL WORKS LTD SCHERING AG SOCIETE CHIMIQUE POINTET GIRARD SA ORSAN SOCIETE ANONYME I I I I I II II II I IV II 8/30/1978 6/20/1978 8/28/1978 9/22/1978 10/13/1978 10/20/1978 RHONE-POULENC YODOGAWA PHARMACEUTICAL CO LTD SIGMA F AND D DIV LTD ORTHO PHARMACEUTICAL LTD SCM CORPORATION EGIS PHARMACEUTICALS PUBLIC LTD CO A I A I I I I I I I III II II IV II IV II II II III I 9/21/1978 7/18/1978 8/9/1978 9/7/1978 9/12/1978 6/28/1978 8/30/1978 10/6/1978 9/21/1978 9/5/1978 10/10/1978 STATUS Type SUBMIT DATE I I N I I I I I I I I I I I I I I I I I I II 6/13/1978 9/19/1978 9/19/1978 9/19/1978 9/19/1978 9/19/1978 9/19/1978 7/8/1978 9/19/1978 6/15/1978 IV IV 9/21/1978 9/7/1978 HOLDER JOHN L ARMITAGE AND CO ETHICHEM CORP NOT AN ASSIGNED NUMBER UNION CARBIDE CORPORATION MEDI PHYSICS INC MEDI PHYSICS INC MEDI PHYSICS INC MEDI PHYSICS INC MEDI PHYSICS INC MEDI PHYSICS INC MEDI PHYSICS INC MEDI PHYSICS INC RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA NOVA CHEMICALS CORP E MERCK MITSUBISHI TANABE PHARMA CORP AMERICAN CYANAMID CO SIGMA F AND D DIV LTD PVO INTERNATL INC RHONE-POULENC MASSACHUSETTS GENERAL HOSPITAL SIEGFRIED AG BCL LTD APOTEX INC UCC MASTER MILKER SYSTEM FOR TC-99 EXTRACTION FROM MO-99 FACILITIES, CONTROLS, AND PERSONNEL A THE SOUTH PLAINFIELD, NJ LOC FACILS., CONTROLS & PERSONNEL-EMERYVILLE, CA.--MEDI-PHYSICS NO. I-E SUBJECT H-852 CLEAR LINER (CHEMICAL COATINGS) SORBITOL

4Q2012

FACILS.CONTROLS & PERSONNEL-ARLINGTON HGTS, ILL--MEDI-PHYSICS NO. I-A FACILITIES, CONTROLS AND PERSONNEL A THE MIAMI LAKES, FLA LOCATION FACILITIES, CONTROLS AND PERSONNEL A THE ROSEMONT, ILL LOCATION FACILITIES, CONTROLS AND PERSONNEL A THE GLENDALE, CA FACILITY QUALITY CONTROL OF RAW MATERIAL & FINAL PRODUCT RELEASE & DISTRIBUTION CORPORATE ADMIN & MANUF. CONTROLS A THE EMERYVILLE, CA. LOCATION PAPAVERINE BASE SCLAIR POLYOLEFINE RESINS TECHNETIUM TC-99M PYROPHOSPHATE NDA 17-913 URSODEOXYCHOLIC ACID CYMEL 1077 DL-CARNITINE SAFFLOWER OIL ZOPICLONE (26,267 R.P.) 1 ALPHA-HYDROXYDIHYDROTACHYSTEROL 3 TRIAMTERENE SINGLE-SIDE COATED REGENERATED CELLULOSE FILMS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. FUMARATE (30,356 R.P.) VALPROIC ACID L-LYSINE MONO HCL OPERATING PROCEDS & PLANT FACILS AT THE DON MILLS, ONTARIO LOC. PARAMOUNT B ALPHA METHYLDOPA USP XIX BULK AS MFG BY EGIS PHARMACEUT WORKS BUDAPEST RUBBER MODIFIED POLYSTYRENE PRODS: 1. TMDB-6800-MANUF MARIETTA OH TRAZODONE HCL SODIUM VALPROATE DM-9327 STABILIZER FUROSEMIDE USP XIX, BULK SPIRONOLACTONE QUINIDINE POLYGALACTURONATE PURE L-GLUTAMIC ACID

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4Q2012EXCEL DMF# 3335 3336 3337 3338 3339 3340 3341 3342 3343 3344 3345 3346 3347 I 3348 3349 3350 3351 3352 3353 3354 3355 3356 3357 3358 3359 3360 3361 3362 3363 3364 I 3365 3366 3367 3368 3369 3370 3371 3372 3373 I I A I I I I I I II II IV II III II IV II III 10/27/1978 11/20/1978 11/8/1978 9/11/1978 10/13/1978 11/20/1978 9/8/1978 10/25/1978 11/3/1978 SIGMA F AND D DIV LTD DELMAR CHEMS LTD CAPSUGEL SYNTEX SA VERTA FOAM COMPONENTS LTD DELMAR CHEMS LTD WARNER JENKINSON CO MIRANOL CHEM CO DUPONT CANADA LTD I I I I I I I I I I I I I I I I II II II II II II II II III III II II III II I II II 10/24/1978 10/24/1978 10/11/1978 10/31/1978 10/20/1978 11/10/1978 10/24/1978 10/13/1978 9/22/1978 10/2/1978 10/13/1978 10/10/1978 10/23/1978 11/20/1978 11/8/1978 8/10/1978 8/29/1978 STATUS Type SUBMIT DATE I I I I I I I I I I I I II II II II II II II II II I II II V 7/4/1978 7/4/1978 7/4/1978 7/4/1978 7/4/1978 7/4/1978 7/4/1978 9/27/1978 9/29/1978 10/24/1978 10/11/1978 10/7/1978 10/26/1978 HOLDER ORSAN SOCIETE ANONYME ORSAN SOCIETE ANONYME ORSAN SOCIETE ANONYME ORSAN SOCIETE ANONYME ORSAN SOCIETE ANONYME ORSAN SOCIETE ANONYME ORSAN SOCIETE ANONYME SIGMA F AND D DIV LTD MEDIMPEX NORTHAMERICA INC UPSHER SMITH LABS INC BOEHRINGER MANNHEIM GMBH MALLINCKRODT INC WEST PHARMACEUTICAL SERVICES LAKEWOOD INC MEDIMPEX NORTHAMERICA INC SIGMA F AND D DIV LTD BOEHRINGER MANNHEIM GMBH ROCHE PALO ALTO LLC KV PHARMACEUTICAL CO GEDEON RICHTER LTD ANTIBIOTICOS SPA ROCHE DIAGNOSTICS GMBH AVON INDUSTRIAL POLYMERS LTD JAITE PACKAGING MEDIMPEX NORTHAMERICA INC ORION CORP LTD FERMION BRITISH SIDAC LTD DELMAR CHEMS LTD PARKE DAVIS & CO SANOFI CHIMIE DINAMITE DIPHARMA SPA SUBJECT PHARMACEUTICAL GRADE L-GLUTAMIC ACID L-GLUMAIC ACID HCL CALIUM L-GLUTAMATE MONOHYDRATE TETRAHYDRATE POTASSIUM L-GLUTAMATE POTASSIUM L-GLUTAMATE (LOW SODIUM CONTENT) MAGNESIUM L-GLUTAMATE L-ASPARTIC ACID PYRIDOXAL HYDROCHLORIDE SPIRONOLACTONE USP XIX FACILITIES AND CONTROLS ALPHA-METHYLDOPA, BULK FORM USP XIX ZOMEPIRAC AS MANUFACTURED IN THE ST. LOUIS, MISSOURI PLANT STERILE PROCESSING FACILITES LOCATED IN LAKEWOOD, NEW JERSEY. NORETHISTERONE ACETATE URIDINE SPIRONOLACTONE (BULK FORM) USP XIX, BP 1973 BUTOCONAZOLE NITRATE SEARLE ANTACID NORETHISTERONE FLUMETHASONE 21-PIVALATE, MICRONIZED AND NON-MICRONIZED QUINIDINE GLUCONATE & SULFATE USP XIX (BULK) & BP 1973 RUBBER COMPONENTS FOR AEROSOL VALVES: 1.AVON COMPOUND 55 P14 PACKAGING LAMINATIONS: MMP-7 ERGOTAMINE TARTRATE CHLORHEXIDINE ACETATE, BPC TRANSPARENT CELLULOSE FILMS BRETYLIUM TOSYLATE, BULK FORM CAPSULE PLANT OPERATION AT THE DETROIT, MICHIGAN FACILITY PROPIONYL PROMAZINE (PROPIOPROMAZINE)

4Q2012

FUROSEMIDE USP MANUFACTURED IN THE BARANZATE DI BOLLATE (MILAN), ITALY FACILITIES FUSARIC ACID HALAZEPAM CAPSULES MANUFACTURED IN GREENWOOD, SOUTH CAROLINA FACILITY CHORIONIC GONADOTROPIN POLYETHER FOAM WADS1. VFC 70 OXTRIPHYLLINE, BULK FORM FLAVORS 1. 0042 VANILLA BOURBON NA AL WS AMPHOTERIC SURFACE ACTIVE AGANTS (MIRANOL 2MCA MODIFIED) SLAIRFILM PRODUCTS AND DARTEK NYLP NOYLON FILM (SL-1,2&3)

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4Q2012EXCEL DMF# 3374 3375 3376 3377 3378 3379 3380 3381 3382 3383 3384 I 3385 3386 3387 3388 3389 3390 I 3391 3392 3393 3394 3395 3396 3397 3398 3399 3400 3401 3402 3403 3404 I 3405 3406 I 3407 3408 3409 A 3410 I II 12/20/1978 HOECHST AG PROCAINAMIDE HCL, BULK DRUG SUBSTANCE A I II III II 1/9/1979 11/28/1978 12/12/1978 I II I 1/9/1979 1/12/1979 SIGMA F AND D DIV LTD USV PHARMACEUTICAL CORP SUB RORER GROUP KYOWA HAKKO BIO CO LTD CITIES SERVICE COMPANY A I I I I I I I I I I I A II II II I II I II II II II I II II 10/31/1978 10/24/1978 11/22/1978 12/1/1978 11/1/1978 11/30/1978 12/6/1978 11/1/1978 12/7/1978 11/30/1978 12/28/1978 1/12/1979 12/6/1978 12/14/1978 I I I I I III II II II II I 10/24/1978 12/1/1978 11/14/1978 11/30/1978 11/1/1978 12/15/1978 MORTON INTERNATIONAL INC DSM ANDENO BRACCO IND CHIMICA SPA MEDIMPEX NORTHAMERICA INC DSM MINERA BV MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC BAYER SCHERING PHARMA AG ANTIBIOTICOS SPA MANUFACTURING ENTERPRISES INC ICI AMERICAS INC SHIONOGI AND CO LTD GANES CHEMICALS INC FRESENIUS USA INC DSM MINERA BV ICI AMERICAS INC SCHMID LABORATORIES INC SIGMA F AND D DIV LTD NOVO NORDISK AS MERCK KGAA PROSINTEX SPA STATUS Type SUBMIT DATE A A I I I A I I I I II III III II III II II II II II I 10/4/1978 10/27/1978 10/3/1978 11/18/1978 10/24/1978 11/2/1978 10/24/1978 11/21/1978 11/2/1978 11/1/1978 12/1/1978 HOLDER LUNDBECK PHARMACEUTICALS ITALY SPA FASSON ROLL NORTH AMERICA DEERFIELD PLASTICS CO INC SIEGFRIED AG MORTON INTERNATIONAL INC BAYER SCHERING PHARMA AG ANTIBIOTICOS SPA KV PHARMACEUTICAL CO SIEGFRIED AG ACF CHEMIEFARMA NV JANSSEN PHARMACEUTICA NV SUBJECT DESIPRAMINE HCL FASLABEL ADHESIVE CONSTRUCTIONS MANUF AT PAINESVILLE, OHIO PLANT POLYTHYLENE FILM PRODUCTS HYDROXYZINE HCL N.F. XIV EPOXY ADHESIVES CONTAINING P-51 WHITE PASTE ESTRADIOL-VALERATE FLUMETHASONE, MICRONIZED AND NONMICRONIZED DIPHENHYDRAMINE HCL 100MG S.R. CAPSULES CYPROHEPTADINE HCL, USP AS MFG AND SOLD UNDER SIEGFRIED LABEL SULFAMETHIZOLE NF XIV

4Q2012

CHEMICAL PRODUCTION & CONTROL OF BPC'S FOR INVESTIGATIONAL USE IN BEERSE, BELGIUM. EPOXY ADHESIVES CONTAINING P-32 BLACK PAST MANUF A WARSAW, INDIANA QUININE HYDROCHLORIDE FF II / NF XI (B15000), IOPAMIDOL, BULK FORM 4 NORANDROSTHENDIONE QUINIDINE SULFATE AS MFG. IN HOLLAND MERCK MANUF FACIL IN CLONMELCOUNTY TIPPERARY, BALLYDINE, IRELAND TESTOSTERONE ENANTHATE FACILITIES AND CONTROLS HALOG-H CREAM (HALCINONIDE CREAM 0.1%) SPAN -65 (SORBITAN TRISTEARATE COMPOUND NUMBER 6059-S METHOHEXITAL AS MANUF ON A CUSTOM BASIS FOR ELI LILLY CO.-BULK POWDER FACILITIES AND CONTROLS FOR DELKA, S.A. (SAN SALVADOR, EL SALVADOR CA) QUININE SULFATE USP XIX/ NF XII TWEEN 65 (SORBITAN TRISTEARATE) (POLYOXYETHYLENE) CANDICIDIN-FACILS FOR THE PRODUCTION OF--LOCATED IN SO.ANDERSON, S.C. O-PHTHALDIALDEHYDE INSULIN USP(MONOCOMPONENT-MC) MANNITOL, PYROGEN-FREE, PRODUCT #5980 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF NALIDIXIC ACID. HYALURONIDASE. FACILS & CONTROLS FOR THE MANUF OF BULK SUBSTANCE A TUCKAHOE, NY MANUFACTURING AND QUALITY INFORMATION ON AMINO MIXTURE TYPE MC HDPE IN THE CS 200 SERIES AS MANUF AT MONSANTO PLANT, TX.

PROQUINA QUIMICOS NATURALES SA DE CV PIPERAZINE ESTRONE SULFATE

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4Q2012EXCEL DMF# 3411 3412 3413 3414 3415 3416 3417 3418 3419 3420 3421 3422 I 3423 3424 3425 3426 3427 3428 3429 3430 3431 I 3432 3433 I 3434 3435 3436 3437 3438 I 3439 3440 3441 3442 3443 3444 3445 3446 3447 3448 I I I I I I I I I I II II II II II II I III II 12/6/1978 1/12/1979 2/9/1979 12/15/1978 2/2/1979 1/17/1979 11/1/1977 2/6/1979 2/2/1979 1/12/1979 MEDI PHYSICS INC SCHERING AG PAR PHARMACEUTICAL INC MOXNESS PRODUCTS INC CYANAMID GREAT BRITAIN LTD PFANSTIEHL LABORATORIES INC FARCHEMIA SANTEN PHARMACEUTICAL CO LTD AMERICAN CYANAMID CO SCHERING AG I I I A III II II II I 5/11/1979 1/25/1979 1/5/1979 11/30/1978 12/15/1978 C II I 1/9/1979 2/22/1979 I I I A I I I I II I I IV I II I I II 1/19/1979 1/24/1979 12/21/1978 1/17/1979 1/16/1979 1/26/1979 8/3/1978 12/29/1978 12/5/1978 STATUS Type SUBMIT DATE I I A I I I I I I A I II II IV II I III II II II II II 12/7/1978 12/20/1978 10/17/1978 1/23/1979 12/14/1978 1/24/1979 1/9/1979 12/22/1978 1/9/1979 10/25/1978 1/9/1979 1/11/1979 HOLDER HELVOET PHARMA NV PHARMA-WALDHOF GMBH MERCK KGAA TAKEDA CHEMICAL INDUSTRIES LTD SIGMA F AND D DIV LTD ACIC LTD CUTTER LABORATORIES INC MD PHARMACEUTICAL INC GANES CHEMICALS INC BASF SE SIGMA F AND D DIV LTD WINTHROP PHARMACEUTICALS DIV STERLING DRUG INC E MERCK ERREGIERRE SPA MD PHARMACEUTICAL INC BELL FLAVORS AND FRAGANCES INC CONTINENTAL DIVERSIFIED INDUSTRIES SIGMA F AND D DIV LTD N&N MENICON INC KOLMAR LABORATORIES INC BECKMAN INSTRUMENTS INC DIV SMITHKLINE BECKMAN CORPORATION SIEGFRIED USA LLC SYNTEX LABORATORIES INC SUB SYNTEX CORP DOWTY SEALS LTD ORION CORP FARMOS CHEMICAL PLANT ISLAND CHEMICAL COMPANY INC BASF PHARMA EVIONNAZ SA MOXNESS PRODUCTS INC SUBJECT CHLOROBUTYL COMPDS: FM 61 AND 62 (PACKAGING MATERIALS (CLOSURES) ADENINE AND ADENINE HCL (SYNTHETIC & FROM RNA OR ADENOSINE) METHYL GLUCAMINE (PRODUCT #6143) CEFSULODIN SODIUM (SCE-129) ARECOLINE HYDROBROMIDE TRIAMTERENE USP IRRIGATION SOLUTIONS IN POLYOLEFIN BOTTLES CARAMIPHEN ETHANE DISULFONATE PHENYLPROPANOLAMINE HCL NF XIV BULK FORM

4Q2012

CREMOPHOR SURFACTANT RH40 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY METHYL COBALAMINE FACILITIES AND MANUFACTURING N,N-DICYCLOHEXYLCARBODIIMIDE, PRODUCT #11650 FACILITIES AND CONTROLS FACILITIES, PROCEDURES FLAVORS MANUF CONTROLS FOR PLASTIC CONTAINERS FOR IRRIGATION & IV SOLUTIONS L-ASPARTIC ACID COUPLER MONOMER FOR N & N MENICON, INC (MAFILCON) SOFT CONTACT LENS FACILS, CONTROLS & PERSONNEL AT RIVERSIDE CALIFORNIA LOCATION SOMATOSTATIN (OVINE) PHENTERMINE & PHENTERMINE HCL USP - GANES FACILITIES,PERSONNEL AND GEN.OPER.PROC.FOR FIELDCREST WAREHSE,ELGIN,IL DOWTY SEALS COMPOUNDS: 1. REFERENCE 0117 FUROSEMIDE QUINIDINE AND QUINIDINE SALTS DIETHYLPROPIONE HCL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. CS-22 CYCLOTRON IN EMERYVILLE,CA AND NEW JERSEY; MC-40 SCANDITRONIX LISURIDE HYDROGEN MELEATE FACILITIES AND CONTROLS PRODUCT & PRODUCT PACKAGING INFORMATION DIAMOX POWDER (ACETAZOLAMIDE) A-D-MELIBIOSE MONOHYDRATE & RAFFINISE PENTAHYDRATE CHLORTHALIDONE THIOLA LOXITANE (LOXAPINE SUCCINATE POWDER), AMOXAPINE LISURIDE HYDROGEN MALEATE

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4Q2012EXCEL DMF# 3449 I 3450 3451 3452 3453 3454 3455 3456 3457 3458 3459 3460 3461 3462 3463 3464 A 3465 I 3466 3467 I 3468 3469 3470 3471 3472 3473 3474 3475 3476 3477 3478 I 3479 3480 3481 3482 3483 I 3484 A IV 3/9/1979 FMC CORP FMC BIOPOLYMER DIV A I I I V II V II I 3/9/1979 3/9/1979 3/9/1979 3/14/1979 3/6/1979 I A A I I I I I I I II II II IV III II III II II I 2/19/1979 1/10/1979 3/14/1979 2/22/1979 2/19/1979 3/6/1979 2/19/1979 12/22/1978 2/1/1979 5/11/1978 2/9/1979 I II III 2/19/1979 6/21/1978 II 3/7/1979 RUETGERS-NEASE CHEMICAL COMPANY INC ACIC LTD KANEGAFUCHI CHEMICAL INDUSTRY CO LTD ACIC LTD BASF PHARMA EVIONNAZ SA NATIONAL STARCH & CHEMICAL CORP ACIC LTD INVISTA SARL ACIC LTD ORGAMOL SA CIBA GEIGY LTD DIAMOND SHAMROCK CORP I I A I I I A I I I I I I A II II II I I I II II II IV II III III II II 1/10/1979 2/12/1979 2/8/1979 2/22/1979 2/6/1979 2/19/1979 12/21/1978 2/27/1979 2/26/1979 2/5/1979 3/7/1979 2/22/1979 2/22/1979 2/19/1979 2/15/1979 STATUS Type SUBMIT DATE II 2/26/1979 HOLDER INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA COWAY CHEM CO LTD GANES CHEMICALS INC SANOFI CHIMIE SEA & SKI CORP ORTHO PHARMACEUTICAL CORP SUNBEAM PLASTICS CORP BASF CORP KYOWA HAKKO KOGYO CO LTD ASSIA TEVA PHILLIPS PETROLEUM CO E MERCK SUMMIT PACKAGING SYSTEMS INC HELVOET PHARMA NV ERREGIERRE SPA MALLINCKRODT INC SUBJECT AMITRIPTYLINE HCL HYDRALAZINE HCL, USP

4Q2012

HALAZEPAM, BULK POWDER-MANUF FOR SCHERING CORP A PENNSVILLE DIVISION METHYL PREDNISOLONE ACETATE FACILITIES AND CONTROLS FACILITIES AND CONTROLS; MANATI, PUERTO RICO PLANT CITE FACILS AND CONTROLS A THE EVANSVILLE, INDIANA LOCATION VITAMIN A ACID (TRETINOIN) DACARBAZINE (AS MANUFACTURED BY SANYO-KOKUSAKU PULP CO.,LTD.) NITROFURAZONE NF-BPC (PETAH TIQWA PLANT) PHILLIPS HYDROCARBON PROPELLANTS AS MANUF IN THE OKLAHOMA FACILS DIBENZOSUBERONE AEROSOL VALVE SYSTEMS: 1. SV-73 BROMOBUTYL COMPOUNDS: FM 153 AND FM 154 URSODEOXYCHOLIC ACID DIETHYLENETRIAMINEPENTAACETIC ACID (DTPA) (ESUB) AS MANUFACTURED IN ST. LOUIS, MO. ZINC PYRION 48% AS IT WILL BE MANUF IN STATE COLLEGE, PA. FACILS SULFAMETHOXAZOLE KANE ACE B-31 TRIMETHOPRIM MEPIVACAINE HCL ADHESIVES METHYLDOPA USP RESINS FOR PHARMACEUTICAL PACKAGING CHLORTHALIDONE USP CHOLINE THEOPHYLLINATE THE KEY PERSONNEL AT THE BASLE FACILITIES IN SWITZERLAND NOPCO JMY AS MNFG. IN THE NEW JERSEY FACILITIES

HENRY H OTTENS MANUFACTURING CO INC FLAVORS:OTTENS PLUS (FLAVOR POTENTIATOR) #3096 AS MANUF IN PA.

WAITAKI INTERNATIONAL BIOSCIENCES SUB N-ACETYL-L-CYSTEINE WAITAKI CANADA LTD JRS PHARMA LP EXPLOTAB FEEDING STUDY-UNIV OF R.I.(SOD. STARCH GLYCOLATE USP/NF) SIEGFRIED AG ROQUETTE NATIONAL CHIMIE OF LILLE DELMAR CHEMS LTD DUPHAR BV ALLOPURINOL (BULK) 3 MONTHS TOXICITY STUDY IN RAS--WITH 2-CARBOXYMETHYL STARCHES IN FEED CK-0569A (BULK) ANTI-PLAQUE AGENT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WEESP, THE NETHERLANDS. AC-DI-SOL MODIFIED CELLULOSE GUM

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4Q2012EXCEL DMF# 3485 I 3486 3487 3488 I 3489 3490 3491 3492 3493 3494 3495 3496 3497 I 3498 3499 3500 3501 3502 3503 3504 3505 3506 3507 3508 3509 3510 3511 3512 3513 3514 3515 3516 3517 3518 3519 3520 I 3521 I I 5/10/1979 I I I A I I A A A I I I I I I A A I A I I I II II I II II II IV II II II II I IV II IV II II II II II I II I 10/15/1978 4/5/1979 3/5/1979 2/28/1979 10/23/1978 4/5/1979 5/1/1979 4/11/1979 4/24/1979 4/27/1979 4/18/1979 4/20/1979 4/4/1979 3/27/1979 1/18/1979 3/8/1979 3/2/1979 4/2/1979 3/30/1979 3/5/1979 3/14/1979 2/10/1979 5/9/1979 I I I I I I I I II II II III I II IV IV III 2/19/1979 3/6/1979 1/30/1979 3/7/1979 3/14/1979 4/9/1979 3/16/1979 7/20/1978 3/27/1979 I I I III I 3/6/1979 2/23/1979 3/23/1979 STATUS Type SUBMIT DATE III 3/6/1979 HOLDER SEARLE LABORATORIES DIV SEARLE PHARMACEUTICALS INC DUPHAR BV VALSPAR CORP SUBJECT MCGAW ADDITIV (R) TRANSFER VIAL (THIS DFORMERLY MCGAW LABS. FACILITIES AND CONTROLS, PART II - PHARMACEUTICAL DEVELOPMENT PLASTIC TUBE--KOROLITH COATING 550X308 & KOROLITH CATALYST 910-801

4Q2012

AMBIX LABORATORIES DIV ORGANICS CORP FACILITIES AND CONTROLS AMERICA ERREGIERRE SPA DIPYRIDAMOLE DUPHAR BV SOGO PHARMACEUTICAL COMPANY LTD HAENDLER & NATERMANN GMBH LEE LABS INC BLASCHIM SPA ROQUETTE NATIONAL CHIMIE OF LILLE CUSTOMCOLOR INC RITODRINE HCL SULPHADIMETHOZINE PACKAGING FOILS - ALUMINUM FACILS., CONTROLS & PERSONNEL AT PETERSBURG PLANT FOR GUAIFENESIN FLUOXYMESTERONE EXPLOTAB BRAND OF SODIUM STARCH GLYCOLATE COLOR COMPOUNDS: 1.BLACK 21,201 CP 24/1 CONCENTRATE

AMOCO CHEMS CORP AFFILIATE AMERICAN AMOCO HIGH DENSITY POLYETHYLENE RESINS (MANUF IN ALVIN, TX) OIL CO CLIN-MIDY SA URATE OXIDASE (URICOZYME) GEDEON RICHTER LTD PARKE DAVIS DIV WARNER LAMBERT CO CAMBREX PROFARMACO MILANO SRL DINAMITE DIPHARMA SPA GEDEON RICHTER LTD DOW CORNING CORP CAMBREX PROFARMACO MILANO SRL BAXTER HEALTHCARE CORP GEDEON RICHTER LTD NAPP TECHNOLOGIES HOECHST CELANESE CORP DEGUSSA CORPORATION SIEGFRIED AG ER SQUIBB AND SONS INC FIS FABBRICA ITALIANA SINTETICI SPA DIPHARMA FRANCIS SRL IRISH FINE CHEMICALS LIMITED DIPHARMA FRANCIS SRL DIOSYNTH BV ELI LILLY AND CO BACHEM FINE CHEMICALS INC BEECHAM LABORATORIES DIV OF BEECHAM INC CIBA GEIGY CORP PHARMACEUTICAL DIVISION VINBLASTIN S04 FACILS. & CONTROLS LOCATED IN FJARDO, PUERTO RICO FACILITY FLURAZEPAM HCL TRIMETHOPRIM BP 73 NANDROLONE DECANOATE 70000 AND 70001 SILICONE ELASTOMERS MANUFACTURED IN HEMLOCK, MI. AMIODARONE HCL IFOSFAMIDE VINCRISTINE SULFATE MFG & CONTRL PROCEDS.--PRODUCT. OF HYDROXYZINE PAMOATE NF XIV-LODI,NJ FACILITIES, PERSONNEL & GENERAL OPERATING PROCEDURES (COVENTRY, R.I.) ELCEMA MICROFINE CELLULOSE AS MANUF AT THE TETERBORO, N.J. LOCATION PROPOXYPHENE NAPSYLATE PLACEBO FOR FLUPHENAZINE HCL TABLETS FUROSEMIDE CHLORPROPAMIDE TRIFLUOPERAZINE TRIAMTERENE USP XIX/BP '73 PREGNANT MARE SERUM GONADOTROPHIN (PMSG) FROM PREGNANT MARE PLASMA ROTOWEIGH (TM) CAPSULE WEIGHING MACHINE A USED IN THE INDIANAPOLIS PL PENTAPEPTIDE, L-ARG-L-LYS-L-ASP-L-VAL-L-TYR MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BRISTOL, TENNESSEE. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BASLE, SWITZERLAND.

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4Q2012EXCEL DMF# 3522 3523 3524 3525 3526 I 3527 I 3528 3529 3530 I 3531 3532 3533 I 3534 3535 3536 3537 3538 3539 3540 3541 I 3542 3543 3544 3545 3546 3547 3548 3549 3550 3551 I 3552 3553 3554 I 3555 3556 3557 I I I II II I 7/12/1979 6/29/1979 6/26/1979 I I I II III 5/16/1979 7/3/1979 7/13/1979 A I I I I I I I I II III II II II II IV I II II 6/12/1979 1/26/1979 5/22/1979 5/25/1979 5/12/1976 6/6/1979 5/22/1979 6/4/1979 6/26/1979 7/3/1979 I A I I A I I II II II II II III II II 4/17/1979 6/4/1979 6/14/1979 5/30/1979 4/3/1979 3/29/1979 4/3/1979 5/31/1979 A I II II I 3/14/1979 5/8/1979 5/4/1979 NISSHIN PHARMA INC SIGMA F AND D DIV LTD CIBA GEIGY CORP PHARMACEUTICAL DIVISION DM GRAHAM LABORATORIES INC SANOFI CHIMIE NOVO NORDISK AS TRAVENOL LABORATORIES INC SIGMA ALDRICH ISRAEL LTD SPARTECH PLASTICS NAPP CHEMICALS INC A A III II I 1/4/1979 5/30/1979 5/11/1979 II 5/4/1979 STATUS Type SUBMIT DATE I I A I II II II II I 5/4/1979 2/22/1979 2/8/1979 5/1/1979 4/13/1979 HOLDER LEIRAS OY POLFA TARCHOMIN DIPHARMA FRANCIS SRL GANES CHEMICALS INC SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP CIBA GEIGY CORP PHARMACEUTICAL DIVISION POLYONE CORP SANOFI CHIMIE APPLIED BIOLOGICAL SCIENCES LAB SUBJECT GLYCOPYRROLATE, USP DIAZEPAM, BULK -MANUF BY POLFA-TARCHOMIN CYPROHEPTADINE HCL, USP TRIAMTERENE, BULK FORM MANUF IN THE NEW JERSEY FACILITIES

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF PRECLINICAL STUDIES IN PHILADELPHIA.PHILADELPHIA LOCATION LAMPRENE (CLOFAZIMINE) AS PRODUCED IN CAPSULE FORM RUCOBLEND COMPOUNDS VEO-600 & VEO-601 PACKAGING MATERIALS PREDNISOLONE ACETATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. PHYTONADIONE, USP (VITAMIN K1) MANUFACTURED IN TOKYO, JAPAN OROTIC ACID ANHYDROUS PERSONNEL, FACILS., CONTROLS COVERING THE CRANSTON, R.I. FACILITY ACCURBRON, S.R. (CONTROLLED RELEASE THEOPHYLLINE) PREDNISOLONE USP MANUFACTURED IN PUTEAUX, FRANCE INSULINS, USP--PREPARATION AND PACKAGING, DOSAGE FORMS BRANCHED CHAIN AMINO ACID INJECTION ENCLOSURES DACTINOMYCIN THERMOPLASTIC SHEET PRODUCTS: 1. NO. 5RTC-911-32C MANUFACTURING & CONTROLS PROCEDURES USED IN PRODUCTION OF TOLBUTAMIDE

AYERST LABORATORIES INC DIV AMERICAN ANTABUSE WITH RIBOFLAVIN TABLETS AND PLACEBO HOME PRODUCTS CORP CHUGAI PHARMACEUTICAL CO LTD SUCRALFATE ;CARAFATE TM VERNAY LABORATORIES INC PET INC SANOFI INC LABORATORY MAG CYCLO CHEM DIV ALAMEDA LABS PET INC SUPERPHARM CORP GANES CHEMICALS INC SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP LUSOCHIMICA S P A PROCOS SPA CIBA GEIGY CORP PHARMACEUTICAL DIVISION ANTIBIOTICOS SPA SIGMA F AND D DIV LTD MILLIPORE CORP COMPOUND VL 1001 M 422 CALIUM STEARATE CONTAING SODIUM LAURYL SULFATE (CS-SLS) PROCHLORPERAZINE EDISYLATE MECLIZINE 2HCL 2-CHLOROPHENOTHIAZINE MAGNESIUM STEARATE CONTAINING SODIUM LAURYL SULFATE (MS-SLS) STANDING OPERATING PROCEDURES ISOXSUPRINE HCL, BULK FORM AS MANUF IN CARLSTADT, NJ CARAMIPHEN EDISYLATE FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES PRENILAMINE LACTATE POLYETHYLENE BOTTLES 17A-HYDROXYPROGESTERONE, BULK PHENYLACETIC ACID DURAPORE (TM)--FILTER MATERIAL & CARTRIDGES AS MFGR IN BEDFORD, MA Page

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4Q2012EXCEL DMF# 3558 3559 I 3560 3561 3562 3563 3564 A 3565 I 3566 3567 A 3568 3569 I 3570 3571 3572 I 3573 I 3574 3575 3576 I 3577 I 3578 3579 I 3580 3581 3582 3583 3584 3585 3586 3587 3588 3589 I 3590 I III 7/20/1979 I I I I I I I I I II III I II II III III II II I 8/6/1979 4/5/1979 7/27/1979 7/22/1979 8/6/1979 2/7/1979 4/5/1979 7/4/1979 8/6/1979 8/28/1979 DIOSYNTH BV ROHM AND HAAS CO DIAGNOSTIC ISOTOPES INC GANES CHEMICALS INC DIOSYNTH BV BORDEN CHEM CO VINYL PLASTICS INC LAEVOSAN GMBH AND CO KG DIOSYNTH BV MCNEIL PHARMACEUTICAL DIV MCNEILAB INC KINGLY PRODUCTS CORP I II I 7/15/1979 8/7/1979 I 7/31/1979 I I III IV II 8/7/1979 8/10/1979 8/9/1979 I 8/6/1979 A I II I V 7/20/1979 7/6/1979 8/9/1979 SANOFI CHIMIE PROSINTEX CHIMICHE ITALIANE SRL I II III 7/20/1979 7/17/1979 I II III 7/20/1979 7/11/1979 II 7/6/1979 I I I I II II II II II 5/16/1979 6/26/1979 7/9/1979 7/2/1979 4/30/1979 STATUS Type SUBMIT DATE A II II 6/22/1979 7/6/1979 HOLDER SIEGFRIED USA INC INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA LUSOCHIMICA S P A MILLIPORE CORPORATION ASH STEVENS INC SIGMA F AND D DIV LTD FRANCO INDIAN PHARMACEUTICALS PVT LTD INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA UPJOHN CO SUBJECT PROPOXYPHENE NAPSYLATE, BULK FORM-MANUF CARLSTADT, NJ FACILITY DIPYRIDAMOLE ISOXSUPRINE HYDROCHLORIDE

4Q2012

DURAPORE (TM) FILTER MATERIAL-FILTER CARTRIDGES -JAFFREY NH FACILITY BULK PREPARATION OF 5-AZACYTIDINE ADENINE - PRODUCT NO. 8626 FD METHOXSALEN PROPRANOLOL HCL. A-125 (U-42,126) ANTI-TUMOR AGENT

AMCOR PHARMACEUTICAL PACKAGING USA MANUFACTURING OF INJECTION MOLDED PARTS INC SYNTEX USA INC RS-5888R (AS MANUF BY SYNTEX RESEARCH IN PALO ALTO, CA ) WEST CO CR-1 CHILD RESISTANT CLOSURE MANUFACTURED BY PLASTICS DIVISION IN MONTGOMERY, PENNSYLVANIA. HYDROCORTISONE ACETATE FACILITIES, PERSONNEL & GENERAL OPERATING PROCEDURES IN MILAN, ITALY

AYERST LABORATORIES INC DIV AMERICAN PRECLINICAL STUDIES USING AY-25,650; SCHALLY ANALOGUE; (D-TRP6)-LH/RH HOME PRODUCTS CORP ADRIA LABORATORIES DIV ERBAMONT INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PLAIN CITY, OHIO. BP CHEMICALS SA POLYETHYLENE PLASTIC PELLETS: PRODUCT NO. DFDM 0111 (NATURAL) HORII PHARMACEUTICAL INDUSTRIES LDT BAROS TM EFFERVESCENT GRANULES AYERST LABORATORIES INC DIV AMERICAN MFG & CONTROL PROCEDS FOR INJECT. DOS FORM AY-25,650; SCALLY ANALOGUE HOME PRODUCTS CORP RECKITT & COLMAN PRODUCTS LTD PHARMACEUTICAL PRODUCTION FACILITY PHARMACEUTICAL DIV BTB CO SPA ANISOTROPINE METHYLBROMIDE PARKEDALE PHARMACEUTICALS INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ROCHESTER, MICHIGAN. ESTRADIOL BENZOATE BLENDEX SERIES (FORMERLY HELD BY BORG-WARNER) GENERAL PLANT MASTER FILE ALLOPURINOL, BULK FORM AS MANUF A PENNSVILLE, NJ FACILITY. PREDNISOLONE TEBUTATE HOT MELT PRODUCTS: 1. HA-6335 HEAT SEAL COATINGS, SP SERIES : 1. SP-20002. SP-2015 LACTULOSE CONCENTRATE (BULK) ESTRONE MICRONIZED MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DORADO, PUERTO RICO. PLASTIC MEDICINE SPOONS Page

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4Q2012EXCEL DMF# 3591 I 3592 3593 3594 3595 3596 3597 3598 3599 3600 3601 3602 3603 3604 3605 3606 I 3607 3608 3609 3610 3611 3612 I 3613 3614 3615 3616 3617 3618 3619 3620 3621 3622 3623 3624 3625 3626 I 3627 3628 I I II III 9/28/1979 10/5/1979 METALLGESELLSCHAFT AG GUARDSMAN PRODUCTS I I I I I I A I I I A I I II III I II II II II II III II II III I I 8/31/1979 9/18/1979 9/18/1979 9/10/1979 8/31/1979 7/9/1979 8/29/1979 9/6/1979 9/13/1979 8/23/1979 8/27/1979 9/21/1979 10/12/1979 10/12/1979 KV PHARMACEUTICAL CO SURGICOT INC MUNDIPHARMA GMBH JT BAKER CHEMICAL CO KV PHARMACEUTICAL CO ASSIA CHEMICAL LABORATORIES LTD CILAG AG DM GRAHAM LABORATORIES INC MITSUI CHEMICALS INC BOEHRINGER INGELHEIM KG UCB PHARMA SA CUTTER BIOL DIV MILES LABS INC PROGRESSIVE PLASTICS INC ETHYL CORP I I C I I II II II II I I 9/10/1979 1/30/1979 9/3/1979 9/11/1979 9/13/1979 9/19/1979 AMERCHOL CORP GIULIANI SPA FARCHEMIA SRL HOFFMANN LA ROCHE INC TOXICOL LABORATORIES LTD ORTHO PHARMACEUTICAL CORP PROMULGEN D (EMULSIFIER) URSODEOXYCHOLIC ACID METRONIDAZOLE, USP RO 3-1428 (5,8,LL,L4-EICOSATETRAYNOIC ACID) -MANUF IN NJ FACILITIES PERSONNEL, FACILS., AND STANDARD OPERATING PROCEDURES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NEW RARITAN, NEW JERSEY. NORPACECR 100MG CAPSULES FLEXIBLE PACKAGING PRODUCTS AND COMPONENTS FACILITIES AND CONTROLS TICRYNAFEN NORPACE (R)CR 150MG CAPSULES TRIAMTEREN AND TRIAMTERENE NDC 12502 - 1819 METHIMAZOLE D-PSEUDOEPHEDRINE FOR TIME RELEASE BEAD TPX PRODUCTS (POLYMERS AND COPOLYMERS OF 4-METHYLPENTENE SCOPOLAMINE AMINOXIDE HYDROBROMIDE HYDROXYZINE HCL IV SOLUTIONS IN POLYOLEFIN BOTTLES-MANUF IN CHATTANOOGA, TN. I I A I I I I I I I I I I A II II II II II IV II II III II II II V II II 8/6/1979 6/15/1979 6/11/1979 8/22/1979 8/6/1979 8/16/1979 8/21/1979 8/22/1979 7/30/1979 8/6/1979 8/22/1979 9/11/1979 8/31/1979 9/5/1979 9/19/1979 DIOSYNTH BV HOECHST AG BAXTER HEALTHCARE CORP ELI LILLY AND CO DIOSYNTH BV NORTHVILLE LABORATORIES SYNTEX USA INC ORGAMOL SA SOLVAY & CIE SA DIOSYNTH BV FINORGA ERCOPHARM CONTINENTAL PHARMA SA SANOFI CHIMIE OTSUKA PHARM CO LTD STATUS Type SUBMIT DATE I 8/10/1979 HOLDER NOVOPHARM LTD SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SCARBOROUGH, ONTARIO, CANADA. METHYLPREDNISOLONE ACESULFAME K (ACETOSULFAM-KGERMAN) CYCLOPHOSPHAMIDE--MANUF AND CONTROLS (PURE SUBSTANCE) ACETAMINOPHEN CAPSULES METHYLPREDNISOLONE ACETATE

4Q2012

F-1888 ARTIFICAL PEACH FLAVOR AS MANUF IN THE NORTHVILLE, MICH FACILS NEW DRUG SUBSTANCE RS-35909-00-00-0 TICLOPIDINE PVC HOMOPOLYMER SOLVIC 271 GA METHYLPREDNISOLONE HEMISUCCINATE TRITHIOZINE PROPANTHELINE BROMIDE FACILS., METHODS & PRECLINICAL DATA FOR PRODUCT CP 804 S KETOPROFEN (19,583 R.P.) PROCATEROL HYDROCHLORIDE HEMIHYDRATE, MANUFACTURED IN TOKUSHIMA, JAPAN

QUALITY CONTROL PROCEDURES RELAIVE TO THE CLEVELAND, OHIO FACILITY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BATON ROUGE, LOUISIANA. LITHIUM CARBONATE ADHESIVES USED AS TUBE END SEALANT FOR FLEXIBLE TUBES

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4Q2012EXCEL DMF# 3629 3630 3631 I 3632 3633 A 3634 I 3635 3636 3637 3638 3639 3640 3641 3642 3643 3644 3645 3646 3647 A 3648 3649 3650 3651 3652 3653 I 3654 I 3655 3656 3657 3658 3659 3660 I 3661 3662 3663 I I I I II II 12/4/1979 12/17/1979 11/27/1979 I I I I A II II II II II I 12/10/1979 11/15/1979 12/6/1979 12/7/1979 11/15/1979 11/21/1979 PFANSTIEHL LABORATORIES INC UNION CARBIDE CORPORATION SALK INST BIOLOGICAL STUDIES CORD LABORATORIES INC SIFAVITOR SRL SCHWARZ PHARMA DIV KREMERS URBAN CO SIDMAK LABORATORIES INC DEGUSSA AG INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA I 12/3/1979 I I I I I III II I II II II 10/23/1979 12/5/1979 12/12/1979 12/6/1979 11/29/1979 12/17/1979 BUNDER GLAS GMBH AINC NEW ENGLAND PHARMACEUTICALS INC SIGMA F AND D DIV LTD HOFFMANN LA ROCHE INC INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA HEALTH CARE INDUSTRY INC I I I A I I I I I I I I II II II III II I II II II I II II III 11/1/1979 11/2/1979 11/1/1979 10/29/1979 11/9/1979 10/29/1979 11/1/1979 11/1/1979 11/9/1979 10/27/1979 11/27/1979 10/6/1979 11/5/1979 I 10/4/1979 I II II 10/22/1979 10/15/1979 PFANSTIEHL LABORATORIES INC RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA PHARMACIA AS STATUS Type SUBMIT DATE I I II II III 10/5/1979 10/3/1979 10/9/1979 HOLDER SCIENTIFIC PROTEIN LABORATORIES INC CILAG CHEMIE AG SILGAN PET CORP SUBJECT CONDRANOL BRAND OF CHONDROITIN 4-SULFATE, BULK PRODUCT NDC 12502 - 1848 PHENAZOPYRIDINE HCL

4Q2012

PACKAGING MATERIALS FOR PHARMACEUTICAL PRODUCTS MANUFACTURED IN PORT CLINTON AND FAIRFIELD, OHIO 2-DEOXY-D-GLUCOSE, NRC-CATALOG NO. D-101--MANUF IN WAUKEEGAN. ILL PAPAVERINE HCL

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HILLEROD, DENMARK. MITSUBISHI CHEMICAL INDUSTRIES LIMITED ETHINYLESTRADIOL, BULK FORM DIOSYNTH BV KV PHARMACEUTICAL CO APTAR FRANCE SAS CHEMSERVICES INC ICN PHARMACEUTICALS KV PHARMACEUTICAL CO FREDERICK CANCER RESEARCH CTR FUTURE PAK LTD ROUSSEL-UCLAF DM GRAHAM LABORATORIES INC SABIC INNOVATIVE PLASTICS 6A-METHYLPREDNISOLONE MEPROSPAN 200MG S.R. CAPS-MANUF ST. LOIUS, MO. FACILS FOR WALLACE LABS APTAR PACKAGING COMPONENTS SULFAMETHOXAZOLE PERSONNEL, FACILITIES AMD CONTROLS MEPROSPAN 400MG S.R. CAPS.-MANUF ST. LOUIS, MO. FOR WALLACE LABS DAUNORUBICIN FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES ESTRONE SOMOPHYLLIN CONTROLLED RELEASE THEOPHYLLINE 250MG CYCOLAC * RESINS AS MANUFACTURED IN OTTAWA, ILLINOIS (USA), TAMPICO, MEXICO, CAMPINAS, BRAZIL, AND SINGAPORE, SINGAPORE PACKAGING MATERIALS/BRONCHOLATOR AND RHINOLATOR TSM MEDIA AND CARTRIDGES FOR PHARMACEUTICAL USE PERSONNEL, FACILITIES AND GENERAL PROCEDURES AMINOOXY ACETIC ACID DOXYLAMINE SUCCINATE AS MANUF IN THE NUTLEY, NEW JERSEY FACILITY QUINIDINE BASE/SULPHATE/GLUCONATE AND POLIGALACTURONATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MICHIGAN, INDIANA. L-LACTIC ACID, SODIUM SALT, 40% SOLUTION (CATALOG #L-104)AS MFG IN ILL CUSTOM GRADE GAS MIXTURE CONTAINING 'CYCLOPROPANE USP' LRF SUPERAGONIST (D-TRP6,PRO9-NET)-LRF THEOPHYLLINE S.R. CAPS 300MG MANUFACTURED IN BROOMFIELD CO. CLIDINIUM BROMIDE, USP PERSONNEL, FACILS, & GEN OPER PROCEDS AT MEQUON, WIS. LOCATION STANDARD OPERATING PROCEDURES MANUAL FOR THE EAST HANOVER, NJ FACILS FACILS & CONTROLS FOR MANUFACTURE OF L-PROLINE IN REXIM PLANT PROPRANOLOL HCL

MITSUBISHI CHEMICAL INDUSTRIES LIMITED METHYLTESTOSTERONE, USP

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4Q2012EXCEL DMF# 3664 3665 I 3666 3667 I 3668 3669 I 3670 3671 3672 3673 3674 3675 3676 3677 3678 3679 3680 3681 3682 3683 3684 3685 3686 3687 3688 I 3689 3690 3691 3692 I 3693 3694 3695 3696 3697 3698 I 3699 I II 1/18/1980 ROCHE DIAGNOSTICS GMBH I A I A I II III II IV II I 1/23/1980 1/14/1980 1/16/1980 1/28/1980 1/9/1980 1/21/1980 A A I II III II I 1/16/1980 12/26/1979 1/10/1980 1/22/1980 I I I I I I I A N N I I I I I A I I III II I III II III II II I 1/8/1980 12/5/1979 1/31/1980 12/28/1979 1/3/1980 1/3/1980 1/31/1980 12/5/1979 1/2/1980 II III II II I II III II 12/28/1979 10/26/1979 12/26/1979 12/7/1979 12/12/1979 12/7/1979 12/26/1979 12/20/1979 I II II 12/20/1979 12/17/1979 SIGMA F AND D DIV LTD INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA ORGAMOL SA AMERICAN NATIONAL CAN CO BAYER HEALTHCARE AG BURDICK & JACKSON LABS,INC DIGIPAK CORP UNIQUE CHEMICALS INMONT CORP BUCHLER GMBH NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER CELANESE PLASTICS & SPECIALTIES CO FOREST LABORATORIES INC BLASCHIM SPA PHILLIPS PETROLEUM CO ANTIBIOTICOS SPA BEACH PRODUCTS INC BLASCHIM SPA FOREST LABORATORIES INC PETPAC (TM) 2413 (POLYESTER RESINS) CAPTOPRIL-F 250MG C.R. TABLETS AS MANUF IN INWOOD, L.I. N.Y. FACILS MANUFACTURING PROCEDURES I II II 12/20/1979 12/13/1979 STATUS Type SUBMIT DATE I II II 9/25/1979 12/21/1979 HOLDER ELI LILLY AND CO INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA ADAMHA NIDA PFANSTIEHL LABORATORIES INC SUBJECT

4Q2012

VIALS DANTRIUM (R)- MANUF INDIANAPOLIS, IND. FOR NORWICH-EATON PHARM. MECLIZINE HCL CANNABININOID FORMULATIONS N-BENZOYL-L-TYROSOL-P-AMINOBENZOIC ACID (BENTIROMIDE) MFG. IN WAUKEGAN, ILLINOIS L-PROLINE HYDROXYZINE HCL CHLOROPROCAINE HCL LAMINATED PACKAGINGS (VINYL TO POLYETHYLENE) AS MANUF IN THE OH FACILS NIFEDIPINE DOXYLAMINE SUCCINATE FACILS & CONTROLS FOR THE PRODUCTION OF CAP LINER CLOSURES MATERIALS METRONIDAZOLE EXTERIOR COATINGS:1002 BARAFENE SYSTEMS MANUF IN CINCINNATI OHIO QUINIDINE BASE, SULFATE, BISULFATE AND GLUCONATE

SOLPRENE STYRENE BLOCK COPOLYMERS AS MANUF IN THE BORGER, TX FACILS. DEXAMETHASONE 21-SODIUM M-SULFOBENZOATE LIQUID UNIT DOSE (ORAL) PACKAGING SYSTEM AS MANUF IN TAMPA, FL DEXAMETHASONE CAPTOPRIL-S 250MG C.R. TABLETS AS MANUF IN THE INWOOD, L.I. NY FACILS

YAMANOUCHI PHARMACEUTICAL COMPANY PERSONNEL, FACILITIES AND CONTROLS LTD UCB PHARMA SA MECLIZINE HCL MITSUBISHI POLYSTER FILM INC SIGMA F AND D DIV LTD RUETGERS-NEASE CHEMICAL COMPANY INC EASTMAN CHEMICAL CO ORACLE FLEXIBLE PACKAGING UCB PHARMACEUTICALS INC FMC CORP FMC BIOPOLYMER DIV ISLAND CHEMICAL COMPANY INC TAYLOR PHARMACAL CO HOSTAPHAN (R) POLYESTER FILMS-MANUF IN GREER, SC L-CARNITINE HCL (FIRST RUN) PERSONNEL, FACILITIES AND CONTROLS NOXELL COMPOUND--1131-69 AS MANUF IN TENNESSE FACILS. PEELABLE BACKING STOCK FOR PVC BLISTER (ALTERNATIVES 1&2) MANUF IN N.C HYDROXYZINE PAMOATE AQUACOAT TM ECD-30 AS MANUF UNDER CONTRACT BY RSA CORP, IN ARDSLEY NY QUINIDINE GLUCONATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DECATUR, ILLINOIS. 5'-IODO-2'-DEOXYURIDINE (IDOXURIDINE, IDU)

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4Q2012EXCEL DMF# 3700 3701 3702 3703 3704 3705 I 3706 I 3707 3708 3709 3710 3711 3712 3713 3714 3715 3716 3717 3718 3719 I 3720 3721 3722 3723 3724 3725 A 3726 3727 3728 I 3729 3730 3731 3732 3733 3734 3735 I I I A I I I II II II I II II I 2/7/1980 2/5/1980 2/7/1980 2/22/1980 2/6/1980 3/7/1980 3/4/1980 I I II III I 2/15/1980 2/15/1980 2/23/1980 HOFFMANN LA ROCHE INC DRG MEDICAL PACKAGING INC SEARLE LABORATORIES DIV SEARLE PHARMACEUTICALS INC DINAMITE DIPHARMA SPA COWAY CHEM CO LTD DIPHARMA FRANCIS SRL ORGANON CANADA LTD CYCLO PRODUCTS INC WARNER LAMBERT CO A I I I I III II II II II II 2/6/1980 2/13/1980 1/29/1980 2/6/1980 2/21/1980 2/7/1980 INEOS OLEFINS AND POLYMERS USA SIEGFRIED LTD FARMAKON SANOFI PHARMACEUTICALS INC HOECHST MARION ROUSSEL SA DIPHARMA FRANCIS SRL FORTILENE (R) POLYPROPYLENE RESINS MANUFACTURED IN TEXAS. SOTALOL HCL AS MFG & SOLD UNDER THE SIEGFRIED LABEL I I I I I I I I I A I I II II II I I II II II II II II II II 2/6/1980 2/4/1980 2/1/1980 2/13/1980 2/1/1980 1/30/1980 2/1/1980 1/30/1980 2/11/1980 1/29/1980 1/28/1980 2/4/1980 10/30/1979 KV PHARMACEUTICAL CO DIOSYNTH BV UPJOHN CO CLARK STEK-O CORP ALLTECH APPLIED SCIENCES UCB SECTEUR PHARMACEUTIQUE MILTON ROY CO SIGMA F AND D DIV LTD CYANAMID GMBH ASTA-WERKE AKTIENGESELLSCHAFT GANES CHEMICALS INC DIOSYNTH BV KV PHARMACEUTICAL CO I 1/30/1980 BIO-TECHNICS LABS INC STATUS Type SUBMIT DATE A I I I I IV I I II I IV 1/22/1980 1/16/1980 1/24/1980 1/9/1980 2/5/1980 2/4/1980 HOLDER ABITEC CORP HOECHST AG MERCK SHARP & DOHME BV ISLAND CHEMICAL COMPANY INC BEECHAM PHARMACEUTICALS DOW CORNING CORP SUBJECT MONO-DIGLYCERIDE, TRADE NAME CAPMUL 8210 (MCM)

4Q2012

PERSONNEL, PROCEDS, FACILS & CONTROL FOR BULK PHARMACEUTICAL PROD. FACILITIES AND CONTROLS QUINIDINE SULFATE USP XX FACILITIES&CONTROLS AT HARLOW AND GREA BURGH RESEARCH SITES, ENGLAND DOW CORNING Q7-2245 AND Q7-2245 SILICONE ELASTOMER MNFG. IN MIDLAND, MI FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LOS ANGELES, CALIFORNIA. THEOPHYLLINE SR62.5MG MNFG IN ST.LOUIS,MO FOR SCHERING,KENILWORTH N.J. PORCINE INSULIN (HIGHLY PURIFIED) SODIUM MECLOFENAMATE AS MFG IN MICHIGAN FACILITIES PERS.FACIL.CNTRLS RE.MNFG ADHESIVE PROD.(CLARCAP SERIES) BAYONNE,NJ PERS,FACIL,CNTRLS AT OAK HALL PA CARBETAPENTANE CITRATE BENTIROMIDE(BTABA= E-2663) AND INTERMEDIATE 6-AMINONICOTINAMIDE LEUCOVORIN CALCIUM MANUFACTURED IN WOLFRASHAUSEN, GERMANY. CYCLOPHOSPHAMIDE INJECTION VIALS PHENTERMINE RESINATE (BULK FORM) SPIRONOLACTONE MICRO PHENYLPROPANOLAMINE75MG/CHLORPHENIRAMINE12MG SRCAP.:WHITEHALL LABS,INC

PROTHIADEN/DOSULEPIN HCL MNFG BY FARMAKON NATIONAL CORP FOR SPOFA LEVONORDEFRIN MNFG A RENSSELAER, NY FACILITIES 1,A,24-DIHYDROXYCHOLECALCIFEROL ISOSORBIDE DINITRATE (ISDN) MANUFACTURED IN THE MERETO DI TOMBA (UD), ITALY FACILITIES LEVORPHANOL TARTRATE AMPULES, 5ML,0.25MG/ML MNFG.IN NEW JERSEY FACIL. GRID PATERN LACQUERED PAPER MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NAUCALPAN, MEXICO PENTHRITE (PETN)---PENTAERYTHRITOL TETRANITRATE CHLOZOXAZONE, PHARMACOPEA NORDICA GLYCERIN TRINITRATE (NITROGLYCERIN-NG) PERSONNEL, FACILITIES AND CONTROLS DEXAMETHASONE THYMOXAMINE HCL BULK,MNFG BY GODECKE AG CHEMICAL,GERMANY(SUBSIDIARY)

MALLINCKRODT SPECIALTY CHEMICALS CO FACILITIES, PERSONNEL,AND G.O.P. FOR THE ST. LOUIS, MISSOURI PLANT

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4Q2012EXCEL DMF# 3736 3737 3738 I 3739 3740 3741 3742 I 3743 A 3744 3745 3746 3747 3748 3749 3750 3751 3752 3753 3754 3755 3756 3757 3758 3759 3760 I 3761 3762 3763 3764 3765 3766 3767 3768 3769 3770 3771 3772 3773 I I I A I I I I I I A I I IV IV II III III II III II I II II II II 4/1/1980 3/27/1980 4/7/1980 3/21/1980 3/26/1980 4/9/1980 3/25/1980 4/17/1980 3/6/1980 3/30/1980 4/15/1980 3/25/1980 4/18/1980 I I A I A I I I I I I I I I I I IV II II II IV II II IV II II II II II I II II II 3/10/1980 3/7/1980 3/10/1980 3/11/1980 3/10/1980 3/10/1980 2/28/1980 3/7/1980 3/10/1980 3/12/1980 3/12/1980 3/10/1980 2/28/1980 4/3/1980 4/7/1980 4/7/1980 4/3/1980 WARNER JENKINSON CO PROCOS SPA GE HEALTHCARE INC NV ORGANON SHIN ETSU CHEMICAL CO LTD MEDI PHYSICS INC PHARMA-WALDHOF GMBH PHILLIPS PETROLEUM CO MEDI PHYSICS INC DIOSYNTH INC GANES CHEMICALS INC MEDI PHYSICS INC KV PHARMACEUTICAL CO MEIJI SEIKA KAISHA LTD SIGMA F AND D DIV LTD DIOSYNTH BV II 3/10/1980 GE HEALTHCARE A I I II III III IV 2/21/1980 3/3/1980 12/19/1979 2/14/1980 DUPONT CHEMOSWED COMATIC LABORATORIES INC SPARTECH PLASTICS FOOD INDUSTRIES INTERNATIONAL LTD 1-AMINOADAMANTANE HCL (AMANTADINE HCL) COMPONENTS AND COMPOSITION OF FOIL COMPOSITES COEXTRUDED LAYERED SHEETS IN THE 5XTR SERIES STATUS Type SUBMIT DATE I I I II II 2/28/1980 2/26/1980 3/14/1980 HOLDER COMATIC LABORATORIES INC CYCLO PRODUCTS INC NOVO NORDISK AS SUBJECT PERSONNEL, FACILITIES AND CONTROLS DEXAMETHASONE ACETATE

4Q2012

ZINC PROTAMINE GLUCAGON NOVO, PREPARATION AND PACKAGING DOSAGE FORMS

FLAVRS:MNFG BROMBOROUGHPORT,WIRRAL,MERSEYSDE,UK:PEACH#23789,31-67-060 CYCLOTRON OPERATION, INDIUM CL (IN 111)MANUFACTURED IN EMERYVILLE, CALIFORNIA. SPRAY DRIED FLAVORS:MNFG MO.,NATURAL&ART.ORANGE FLAVOR #4168 PROGLUMIDE THALLOUS CL (TL-201) (CYCLOTRON OPERATION), NORTH ARLINGTON, ILLINOIS MEDROXYPROGESTERONE ACETATE MICRO HYDROXYPROPYL METHYLCELLULOSE 60SH 50CPS, METALOSE 60SH 50 CYCLOTRON-I-123 EMERYVILLE,CA; SOUTH PLAINFIELD,NJ; NORTH ARLINGTON,IL 5-BROMO-2' -DEOXYURIDINE (BDU)-PRODUCT NO. 6706 PHILPRENE STYRENE-BUTADIENE COPOLYMERS MNFG IN OKLAHOMA FACILITIES GALLIUM (GA 67) EMERYVILLE,CA; SOUTH PLAINFIELD,NJ; NORTH ARLINGTON,IL HEPARIN SODIUM USP (BEEF LUNG) AS MFG. IN THE ILLINOIS FACILITIES SOTALOL HCL KRYPTON (KR 81M) EMERYVILLE,CA;SOUTH PLAINFIELD,NJ;NORTH ARLINGTON,ILL HYOSCYAMINE SO4 & HYOSCYAMINE S04 W/PHENOBARBITAL SR CAPS-KREMERS PERSONNEL, PROCEDURES, FACILITIES AND CONTROLS BETA-ESTRADIOL-3-BENZOATE TRIAMCINOLONE MICRO

UNIV OF IOWA PHARMACEUTICAL SERVICES LEVO-ALPHA-ACETYLMETHADOL (LAAM)-PRODUCED FOR NA'L INST. DRUG ABUSE COLLEGE OF PHARMACY V MANE FILS INC FLAVORS AS MANUF IN FRANCE BY V. MANE FILS, S.A.1.WONF LEMOM E10054 REXENE CORP DIOSYNTH BV KLOCKNER PENTAPLAST GMBH 3M PHARMS ARSYNCO INC CONTOUR PACKAGING CORP NAPP CHEMICALS INC POLAROID CORP SIGMA F AND D DIV LTD SANOFI AVENTIS CHIMIE AINC FOOTE MINERAL COMPANY POLYPROPYLENE RESINS IN THE PP 11M AND PP 21M SERIESTRIAMCINOLONE ACETONIDE MICRO THERMOFORMABLE RIGID PVC SHEET (PENTAPHARM)-MFGR IN GORDONSVILLE, VA. SECUR-A-SEAL EDGE SEALING TAPES: L. TAPE YR-8027-2--IN MINNESOTA FACIL PHENYL PROPANOLAMINE HCL AS MANUF.IN THE CARLSTADT,N.J. FACILITY PLASTIC BOTTLES AS MANUF IN THE PENNSYLVANIA FACILITY MEPIVACAINE HCL AS MANUF IN THE LODI, NJ FACILITIES PERSONNEL AND FACILITIES IN MASSACHUSETTS THIOPROLINE METHYLPREDNISOLONE MANUFACTURED IN VERTOLAYE, FR. 1DEP MEDIA & CARTRIDGES FOR PHARMACEUTICAL USE-MANUF IN CT. FACILITIES LITHIUM CARBONATE, USP

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4Q2012EXCEL DMF# 3774 3775 3776 3777 A 3778 3779 3780 3781 3782 3783 3784 3785 3786 3787 3788 I 3789 I 3790 I 3791 3792 I 3793 3794 3795 3796 3797 3798 3799 3800 I 3801 3802 I 3803 3804 3805 3806 3807 3808 C I I I A I II II I II II II 5/20/1980 4/11/1980 4/28/1980 3/18/1980 5/20/1980 5/9/1980 NV ORGANON LOFTUS BRYAN CHEMICALS LTD BERLEX LABORATORIES INC FARCHEMIA NV ORGANON CENTRAL PHARMACEUTICALS INC I I I 11/7/1979 3/18/1980 I A I I I I I II V II IV I II II II 3/13/1980 4/8/1980 5/7/1980 5/1/1980 5/9/1980 4/29/1980 5/20/1980 5/9/1980 I III II 4/22/1980 4/23/1980 SPARTECH PLASTICS RUETGERS-NEASE CHEMICAL COMPANY INC THE CENTRAL PHARMACAL COMPANY UNIV IOWA COLL PHARMACY CHEMSERVICES INC E MERCK GIST BROCADES ROUSSEL-UCLAF DIOSYNTH BV LABORATOIRES D'ETUDES ET DE RECHERCHES SYNTHELABO DM GRAHAM LABORATORIES INC FARCHEMIA COMPOSITE THERMOPLASTIC SHEETS IN THE HTR SERIES-MANUF IN MASS. LITHIUM CARBONATE, BULK--MANUF IN THE PENN. FACILITIES DYPHYLLINE SUSTAINED RELEASE CAPSULES STERILE PRODUCTS MANUFACTURING PROCEDURES IN IOWA CITY, IOWA TRIAMCINOLONE ACETONIDE, USP IN THE EAST HANOVER, NJ FACILITIES PRODUCT 8198 TABLETING AID T FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES CORTISONE ACETATE 'D' TUBOCURARINE CHLORIDE BETAXOLOL PERSONNEL, FACILS. AND CONTROLS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. ETHINYL ESTRADIOL IMIPRAMINE HCL PERSONNEL, FACILS, & CONTROLS AT WAYNE, NJ LOCATION TRIAMTERENE, USP HUMAN CHORIONIC GONADOTROPHIN (HCG) II 4/18/1980 M AND T CHEMS INC I 3/31/1980 I I I I A I I I I I II II II II III II III II II II I 4/7/1980 4/15/1980 3/14/1980 4/15/1980 4/9/1980 4/17/1980 4/17/1980 3/24/1980 3/24/1980 4/15/1980 3/26/1980 ANI PHARMACEUTICALS INC ROUSSEL-UCLAF KNOLL AG LUDWIGSHAFEN ROUSSEL-UCLAF SELIG SEALING PRODUCTS INC THOMPSON HAYWARD CHEMICAL CO ALUMINUM COMPANY OF AMERICA MUSKEGON CHEMICAL CO ANTIBIOTICOS SPA ROUSSEL-UCLAF STATUS Type SUBMIT DATE I I A II II II III 3/28/1980 4/15/1980 3/7/1980 4/10/1980 HOLDER FISONS LTD ROUSSEL-UCLAF FIS FABBRICA ITALIANA SINTETICI SPA BAXTER HEALTHCARE CORP SUBJECT IRON DEXTRAN INJECTION METHYLTESTOSTERONE USP PENTAZOCINE AND PENTAZOCINE HCL

4Q2012

POLYOLEFIN (PL-325) POUR BOTTLE (FOUR VOLUMES) MANUFACTURED IN ROUND LAKE, ILLINOIS AND CLEVELAND, MISSISSIPPI. LITHIUM CARBONATE PILOT PROCESS AS MANUF IN THE MINNESOTA FACILITIES METHYLPREDNISOLONE HEMISUCCINATE MANUF FOR ROUSSEL UCLAF PAMABROM (8-BROMOTHEOPHYLLINE-ISOBUTANOLAMINE) TESTOSTERONE ENANTHATE INNERSEAL MATERIALS MANUFACTURED IN MINNESOTA. FORMULA T-DET N-9.5 AS MANUF IN THE KANSAS FACILITY FORMED FOIL CONTAINERS IN THE PHAR SERIES-MANUF IN PENN. FACILITIES DIETHYL CARBAMAZINE AS MANUF IN THE MICH. FACILITIES FLUOROMETHOLONE 17-ACETATE NON-MICRONIZED AND MICRONIZED TRIAMTERENE

MALLINCKRODT SPECIALTY CHEMICALS CO FACILITIES-PERSONNEL-GEN. OPERATING PROCEDURES RALEIGH NC CHEM. PLANT EON LABS MFG OF THE VIRGIN ISLANDS INC FACILITIES, PERSONNEL & GEN. OPERT. PROCEDS-SPRINGFIELD GARDENS, NY STANNOCHLOR (STANNOUS CHL., ANHYDROUS)-MANUF IN CARROLLTON, KY. FACILS

USP SODIUN CHLORIDE TABLETS AS MANUF IN THE SEYMOUR, INDIANA FACILS

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4Q2012EXCEL DMF# 3809 I 3810 I 3811 3812 I 3813 3814 3815 3816 3817 3818 3819 3820 3821 3822 3823 3824 3825 3826 3827 3828 3829 3830 3831 I 3832 I 3833 3834 I 3835 A 3836 3837 3838 3839 3840 3841 3842 I 3843 I I 6/16/1980 I I I I A I II II II II II II II 6/12/1980 5/21/1980 6/16/1980 6/10/1980 6/10/1980 5/21/1980 6/11/1980 II 6/10/1980 I II I 5/21/1980 6/11/1980 III 4/14/1980 I I I I I I I I I I A I I I I I C I III I II I II I II I I IV II I II III II II II II II 3/18/1980 5/23/1980 5/20/1980 5/23/1980 5/20/1980 5/29/1980 5/21/1980 8/9/1979 4/18/1980 6/11/1980 5/20/1980 6/10/1980 4/22/1986 5/27/1980 5/21/1980 6/11/1980 5/21/1980 5/30/1980 6/10/1980 SARGENT INDUSTRIES PARKE DAVIS DIV WARNER LAMBERT CO DIOSYNTH BV HOPE CO MALLINCKRODT INC PARKE DAVIS DIV WARNER LAMBERT CO DIOSYNTH PARAMOUNT PACKAGING CORP SCHARPER SPA SIGMA F AND D DIV LTD NV ORGANON PRESS PAK INC CAMBREX PROFARMACO MILANO SRL CELANESE PLASTICS DIOSYNTH BV AMINO GMBH NV ORGANON NOVO NORDISK AS I II I 5/20/1980 5/14/1980 I 5/19/1980 STATUS Type SUBMIT DATE III 5/6/1980 HOLDER ABBOTT LABORATORIES HOSP PRODUCTS DIV SCHERING CORP SUB SCHERING PLOUGH CORP DIOSYNTH BV TIME CAPS LABORATORIES INC SUBJECT PHYSICAL COMPAIBILITY: PHASE IV LIFECARE FLEXIBLE CONTAINERS

4Q2012

FACILS, PERSONNEL & GEN OPERATING PRCEDS A ST. LOUIS MISSOURI FACILS. NOERTHINDRONE ACETATE MICRONIZED MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NEW CASSEL, LI, NY. O-RINGS, RUBBER SEAL & COMPONENTS AS MANUF IN THE CARLSBAD, CA FACILS. WARNER-LAMBERT, CAPS PLANT OPER, BROCKVILLE, ONTARIO, CAN FACILITY OXYTOCIN ACETATE PERSONNEL, FACILITIES AND CONTROLS DIARIZOIC ACID USP (HYDROUS) PRODUCED IN ST. LOUIS, MISSOURI PLANT PERSONNEL, FACILS & GEN OPER PROCEDS AT THE LITITZ, PA FACILITY PREDNISOLONE SODIUM PHOSPHATE PRODUCT SPECIFICATIONS (SOME FORMERLY LISTED IN D1366) FACILITIES AND CONTROLS GUM, LOCUST BEAN PROGESTERONE PERSONNEL, FACILITIES AND GENERAL OPERATING PROCEDURES ACETOHEXAMIDE MFG.PAULLO(MILANO)FACILITY ON VIA CURIEL(WAS LIDOCAINE) MED PACKAGING ADHESIVES: 1. ADHESIVE XP-22189-66-4 (MANUF IN KY & ILL) ANDROSTADIENOLONE UNDECYLENATE L-LEUCINE ESTRADIOL MICRONIZED PURIFIED INSULIN

MCNEIL CONSUMER HEALTHCARE DIV NICORETTE (R): PRODUCTION OF CHEWING GUM AT THE ESBJERG, DENMARK PLANT MCNEIL PPC INC CONOCO CHEMICAL DIVISION CONTINENTAL POLYETHYLENE RESINS IN THE NP SERIES AS MANUF IN THE OKLA FACILITIES OIL CO DIOSYNTH INC ESTRADIOL CYPIONATE WHITEHALL LABS DIV AMERICAN HOME PRODS CORP MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC SIGMA F AND D DIV LTD DIOSYNTH BV AMERCHOL CORP AB LEO INSTITUTO MASSONE S A DIOSYNTH BV CYTEC INDUSTRIES BUSINESS UNIT AMERICAN CYANAMID CO NOVARTIS PHARMACEUTICALS CORP PERSONNEL, FACILS AND CONTROLS FOR THE HAMMONTON, NJ PLANT NICORETTE 4-AMINOPYRIDINE ESTRIOL PROPAL (ISOPROPYL PALMITATE) AS MANUF IN THE MAMARONECK, NY FACILS NICORETTE (R): PRODUCTION OF ION EXCHANGE RESIN A THE RAA, SWEDEN PLA HUMAN CHORIONIC GONADOTROPIN DEXAMETHASONE SODIUM PHOSPHATE DISODIUM PAMOATE MONOHYDRATE (DISP) PERSONNEL, FACILS & GEN OPERATING PROCEDURES AT EAST HANOVER, NJ.

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4Q2012EXCEL DMF# 3844 3845 3846 3847 I 3848 3849 3850 3851 3852 3853 3854 3855 3856 3857 3858 3859 3860 A 3861 3862 3863 3864 3865 3866 3867 3868 3869 3870 3871 3872 3873 3874 3875 3876 3877 3878 I 3879 3880 3881 3882 A A I I II II II III 7/14/1980 6/20/1980 6/30/1980 5/16/1980 KONGO CHEMICAL CO LTD UCB PHARMA SA DIOSYNTH BV WEST AMERICAN RUBBER CO A I I I I I I I I I I A A I I I A II II II II II II II II II II II II II II II II II I 5/21/1980 6/23/1980 7/3/1980 7/10/1980 6/19/1980 7/3/1980 6/20/1980 6/20/1981 6/13/1980 7/14/1980 7/9/1980 7/11/1980 6/16/1980 6/27/1980 7/4/1980 6/10/1980 6/25/1980 6/18/1980 NV ORGANON GEDEON RICHTER, LTD. MARION LABORATORIES INC DAIICHI SEIYAKU CO LTD DIOSYNTH BV DEGUSSA AG SA AJINOMOTO OMNICHEM NV UCB PHARMACEUTICALS INC DIOSYNTH BV KONGO CHEMICAL CO LTD SIGMA F AND D DIV LTD EVONIK DEGUSSA CORP NV ORGANON UCB PHARMACEUTICALS INC 3M PHARMS FERRING AB NV ORGANON BIDACHEM SPA I C I I I I I I I A I I II II I II II II II I I II II II IV 6/18/1980 5/22/1980 5/28/1980 3/26/1980 6/23/1980 6/6/1980 6/13/1980 5/29/1980 4/23/1980 5/21/1980 7/3/1980 7/4/1980 7/9/1980 SIGMA F AND D DIV LTD NV ORGANON LYNE LABORATORIES INC ISF MERCK SHARP & DOHME RESEARCH LABS NV ORGANON MEDIMPEX NORTHAMERICA INC SCHUPBACH AG PRB CHEMIE NV ORGANON SIGMA F AND D DIV LTD 3M PHARMS SYMRISE INC STATUS Type SUBMIT DATE I I I I II II I 5/30/1980 5/21/1980 6/25/1980 5/29/1980 HOLDER ANALYTICAL BIO-LABS INC DIOSYNTH BV LONZA INC IVERS LEE AG SUBJECT

4Q2012

PERSONNEL FACILITIES & GENERAL OPERATING PROCEDURES-COLUMBIA MO HYDROXYPROGESTERONE CAPROATE DEXTROMETHOPHAN HYDROBROMIDE AS MFG. IN THE LOS ANGELES, CA.FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES . DL-THREO-3,4-DIHYDROXYPHENYLSERINE NORETHINDRONE PERSONNEL, FACILS, METHODS & CONTROLS AT THE WESTWOOD, MASS. LOCATION ISF 2522 (4-HYDROXY-2-0X0-1-PYRROLIDIN-ACETAMIDE) DIFLUNISAL-MANUF A MSD,LTD PLANT IN PONDERS END,MIDDLESEX, ENGLAND STABILIZED MIXTURE OF CONJUGATED ESTROGENS VINPOCETINE (CAVITON R)-MANUF BY CHEMICAL WORKS OF GEDEON RICHTER LTD. METHODS, FACILS & CONTROLS RELATED TO PACKAGING MATERIALS QUININE DERIVAIVES FACILITIES DESCRIPTION TESTOSTERONE CYPIONATE BACITRACIN ZINC ADRENALONE HYDROCHLORIDE COLORS,FLAVORS,SCENTS,OTHER ADDITIVES MANUFACTURED IN FAIRLAWN, NEW JERSEY. METHYLTESTOSTERONE SULFINPYRAZONE MFG BY CHEMICAL WORKS OF GEDEON RICHTER, LTD (BUDAPEST) PAVABID (R) HP CAPULETS,300MG AS MANUF. IN THE KANSAS CITY,MO. FACILS TRANEXAMIC ACID BOVINE INSULIN GLYCINE AS MANUF BY THE REXIM S.A. DIV. OF DEGUSSA IN HAM,FRANCE DIPYRIDAMOLE PIRACETAM MEGESTROL ACETATE MICRO FOLIC ACID DL-PHENYLALANINE L-LYSINE.H20 AS MANUF. BY THE REXIM S.A. DIV. OF DEGUSSA IN HAM,FRANCE STABILIZED MIXTURE OF ESTERIFIED ESTROGENS BUCLIZINE HCL ADRENALINE (EPINEPHRINE) AND SALTS OF EPINEPHRINE OXYTOCIN TESTOSTERONE ENANTHATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES DIPHENHYDRAMINE HCL USP MESNA BOVINE INSULINE HIGHLY PURIFIED PHARMACEUTICAL DIAPHRAGM & AEROSOL VALVE MATERIALS-ORANGE,CA Page 105 FACILS.

4Q2012EXCEL DMF# 3883 I 3884 3885 3886 3887 3888 3889 3890 3891 3892 3893 3894 3895 3896 3897 3898 3899 3900 3901 3902 I 3903 3904 3905 3906 3907 3908 3909 3910 A 3911 I 3912 3913 3914 3915 3916 3917 3918 3919 3920 I I I I I I I I I II II II II II II II I II 7/18/1980 4/4/1980 8/5/1980 7/21/1980 7/21/1980 7/17/1980 7/18/1980 7/16/1980 8/5/1980 POLIPHARM SPA DIOSYNTH BV DEGUSSA AG COSMA SPA FBA PHARMS INC DIV BAYCHEM CORP DIOSYNTH INC POLIPHARM SPA STANNIOLFABRIK BURGDORF AG DEGUSSA AG I 6/16/1980 I I I A I I I II II II II I II III II 6/24/1980 8/4/1980 8/8/1980 8/5/1980 8/11/1980 7/17/1980 1/15/1980 7/18/1980 I A I I I I N N N N N N N N N N I I II II II 7/11/1980 6/26/1980 7/16/1980 II II I II II I 7/3/1980 7/14/1980 7/11/1980 7/22/1980 7/3/1980 6/2/1980 STATUS Type SUBMIT DATE II 6/25/1980 HOLDER BECKMAN INSTRUMENTS INC DIV SMITHKLINE BECKMAN CORPORATION DEGUSSA AG KONGO CHEMICAL CO LTD SA ISOPLAST AG BRUGG ROEHR CHEMICALS INC DEGUSSA AG SOCIETA ITALIANA CORTICOSTEROIDI SPA NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER CINTICHEM INC ICI AMERICAS INC LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO MEDIMPEX NORTHAMERICA INC MCGAW INC SIGMA F AND D DIV LTD EVONIK CORPORATION RACHELLE LABORATORIES INC DIOSYNTH BV CELANESE PLASTICS & SPECIALTIES CO RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA SPA SELOC PHARMA AG SELENIUM SE 75 MOSE MANUFACTURED IN TUXEDO, NEW YORK. BRIJ 58 (POLOXYETHYLENE(20)CETYL ETHER)-MANUF. IN THE DEL.FACILS. CARBONYL CHLORIDE MNFG A BOUND BROOK, NEW JERSEY SUBJECT BETA-ENDORPHIN (HUMAN) - MANUF. IN THE PALO ALTO,CA FACIL. L-LYSINE 50% - MANUF. BY REXIM S.A. DIV. OF DEGUSSA IN HAM,FRANCE CHLORPHENIRAMINE MALEATE USP FACILITIES AND GENERAL OPERATING PROCEDURES. PHENYLPROPANOLAMINE HCL AS MAUF IN LONG ISLAND CITY FACILITIES

4Q2012

L-HISTIDINE HCL MONOHYDRATE -MANUF. BY REXIM S.A. DIV. DEGUSSA,FRANCE FACILITIES,PERSONAL AND GENERAL OPERATING PROCEDURES

METHANDROSTENOLONE AS MANUF-BY CHEM WORKS OF GEDEON RICHTER, LTD METRONIDAZOLE INJECTION 0.5%,MNFG IN SOUTHERN CALIFORNIA FACILITIES QUINACRINE HCL. L-LYSINE.ACETATE-MANUF.BY REXIM S.A. OF DEGUSSA IN HAM,FRANCE FACILITIES, PERSONNEL & GENERAL OPERATING PROCEDURES CORTISONE ACETATE MICRO MEDICAL PACKAGING ADHESIVES;1.22188-54 IN THE KENTUCKY FACILITY DIPHENHYDRAMINE HCL USP MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF ISOSORBIDE DINITRATE DILUTED BY SIFA LTD IN CLARE, IRELAND. IMIPRAMINE HCL USP L-PROPLYL-L-LEUCYL-GLYCINAMIDE (MIF) L-ARGININE - MANUF. BY REXIM S.A. DIVISION OF DEGUSSA IN HAM,FRANCE SULFINPYRAZONE CHLOROQUINE DIPHOSPHATE HYDROCORTISONE MICRONIZED HYDRALAZINE HCL USP MANUFACTURING FACILITIES FOR BLOW EXTENSION THERMOPLASTIC MATERIALS L-HISTIDINE -MANUF. BY REMIX S.A. DIV.OF DEGUSSA IN HAM,FRANCE

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4Q2012EXCEL DMF# 3921 3922 3923 3924 3925 3926 3927 3928 3929 3930 3931 3932 3933 3934 3935 I 3936 3937 3938 3939 3940 3941 3942 I 3943 3944 3945 3946 3947 3948 3949 3950 3951 3952 3953 3954 3955 3956 3957 3958 3959 A I I I I A I I I I A I I I A I I IV II II II I III II II II III II II II II II II II 9/2/1980 7/30/1980 5/17/1980 8/11/1980 10/9/1980 10/15/1980 7/17/1980 10/8/1980 9/22/1980 10/7/1980 8/20/1980 9/22/1980 10/8/1980 7/17/1980 10/6/1980 10/8/1980 9/3/1980 I I I A A I III I II II IV II II 8/27/1980 2/15/1980 9/12/1980 9/11/1980 9/18/1980 9/5/1980 8/29/1980 STATUS Type SUBMIT DATE I I I I I I I I I I I I A I II II I II I II I II III II II II III II II 7/17/1980 7/18/1980 8/18/1980 8/5/1980 7/24/1980 7/31/1980 8/6/1980 8/5/1980 8/8/1980 8/18/1980 9/3/1980 9/10/1980 9/3/1980 9/9/1980 8/21/1980 HOLDER DIOSYNTH BV POLIPHARM SPA ASTRA USA INC DEGUSSA AG WEST PHARMACEUTICAL SERVICES INC SANOFI SYNTHELABO INC. LABORATOIRE FISONS SOCIETE ANOMYME DEGUSSA AG SCHIONNING & ARVE AS GLYCO CHEMICALS INC HERCULES INC SIGMA F AND D DIV LTD BALL AEROCAN FRANCE SAS SHIONOGI AND CO LTD SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP SANTA FE RUBBER PRODUCTS INC CEBAL SIGMA F AND D DIV LTD NV ORGANON CAPSUGEL ACF CHEMIEFARMA NV BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG CAPSUGEL CENTRE DE RECHERCHES CLIN MIDY DIOSYNTH BV FOREST PHARMACEUTICALS INC AMERICAN CONTRACT PACKAGERS INC SELIG SEALING PRODUCTS INC DIOSYNTH BV EASTMAN CHEMICAL CO NV ORGANON SARONG SPA KLINGE CHEMICALS LTD SIGMA F AND D DIV LTD HOPE CO DIOSYNTH BV TEVA PHARMACEUTICAL INDUSTRIES LTD SIGMA F AND D DIV LTD CIECH POLFA SUBJECT HYDROCORTISONE ACETATEMICRO DOXYLAMINE SUCCINATE USP FACILITIES AND CONTROLS AT THE WESTBORO, MASS LOCATION L-ORNITHINE HCL -MANUF.BY REXIM S.A. DIV. OF DEGUSSA IN HAM,FRANCE MANUFACTURING FACILITIES

4Q2012

CLOROQUINE PHOSPHATE -MANUF. IN THE RENSSALATER,NEW YORK FACILITIES. FACILITIES AND GENERAL PROCEDURES L-TYROSINE-MANUF.BY REXIM S.A. DIV. OF DEGUSSA IN HAM,FRANCE RUBBER SHEET COMPOUNDS: COMPOUND 6247 TRADE NAME GLYDANT-MFG. IN WILLIAMSPORT,PA FACILITIES NITROGLYCERINE/PROPYLENE GLYCOL ADENYLOSUCCINIC ACID EPOXY COATED ALUMINUM CANISTERS MFG IN BELLEGARDE FRANCE COMPOUND # 450088-S MANUFACTURED IN OSAKA, JAPAN. CHLORPHENIRAMINE MALEATE MOLDED RUBBER PROD,FOR PHARM.PCKG MNFG WHITTIER, CA., COMPOUND 70-13 FACILITIES & PROCEDURES ACETOHYDROXAMIC ACID DESONIDE MICRO GELATIN CAPSULES MANUFACTURED IN COLMAR, FRANCE SULFADIAZINE THEOPHYLLINE, ANHYDROUS GELATIN CAPSULES MFG IN BORNEM, BELGIUM SOMATOSTATIN ACETATE HYDRATE (CM 9357) PREDNISOLONE MICRO ANTILIRIUM (PHYSOSTIGMINE SALICYLATE) PERSONNEL,FACILITIES AND GENERAL OPERATING PROCEDURES 3M BRAND PRESSURE ACTIVATED INNERSEAL CLOSURE MATERIALS-ST.PAUL,MN PREDNISOLONE ACETATE MICRO CET ISOTHIOUREA-MFG BY EASTMAN CO,TENN.--USED BY SKF IN CIMETIDINE MESTRANOL LAMINATED PACKAGING MATERIALS: 1. POLYVINYLCHL. POLYETHYLENE FILM POTASSIUM CHLORIDE USP BETA-GLYCEROPHOSPHATE GRADE XII CALCIUM SALT SYNTHESIS OF BULK SODIUM SULFATHIAZOLE SESQUIHYDRATE PREDNISONE MICRO CLOMIPHENE CITRATE USP DEHYROISOANDROSTERONE ACETOZOLAMIDE

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4Q2012EXCEL DMF# 3960 3961 3962 3963 3964 3965 3966 3967 I 3968 3969 3970 I 3971 3972 3973 3974 3975 3976 3977 3978 3979 3980 3981 3982 3983 3984 I 3985 I 3986 I 3987 3988 I 3989 3990 3991 3992 3993 3994 3995 I I A I I I I I II II IV II III I 11/18/1980 11/24/1980 5/22/1980 11/4/1980 9/15/1980 11/18/1980 12/10/1980 I II III 11/5/1980 11/17/1980 DEGUSSA AG FASSON INDUSTRIAL DIVISION OF AVERY INTERNATIONAL ANTIBIOTICOS SPA ORGANICHEM CORP EVONIK CORPORATION PARKE DAVIS DIV WARNER LAMBERT CO UNION CARBIDE CORPORATION BASF WYANDOTTE CORP DUPONT MERCK PHARMA II 11/18/1980 WARNER LAMBERT CO I 11/21/1980 I I I I I I I I I I I I I II II II II IV II II II II II II III II I 11/6/1980 9/12/1980 5/22/1980 10/23/1980 11/6/1980 11/10/1980 5/22/1980 11/4/1980 11/13/1980 10/21/1980 5/22/1980 8/29/1980 11/17/1980 11/17/1980 I I II II I 10/21/1980 11/3/1980 11/7/1980 STATUS Type SUBMIT DATE I I I A I I I II II II II I I II II 9/30/1980 10/6/1980 9/25/1980 10/10/1980 10/17/1980 10/16/1980 9/26/1980 10/23/1980 HOLDER ELI LILLY AND CO DIOSYNTH BV BOEHRINGER MANNHEIM GMBH SANOFI CHIMIE MALLINCKRODT INC LINSON LTD BOEHRINGER MANNHEIM GMBH BIOFAR INSUMOS QUIMICO FARMACEUTICOS SA KV PHARMACEUTICAL CO KV PHARMACEUTICAL CO WHITEHALL LABS DIV AMERICAN HOME PRODS CORP JT BAKER CHEMICAL CO BOEHRINGER MANNHEIM GMBH DEGUSSA AG DIOSYNTH BV HETERENE CHEMICAL COMPANY INC SIGMA F AND D DIV LTD DEGUSSA AG INDUSTRIA CHIMICA PROFARMACO SPA SOCIETA ITALIANA CORTICOSTEROIDI SPA PARKE DAVIS DIV WARNER LAMBERT CO DEGUSSA AG PARCOR (USA) RADIOCHEM CTR AEROJET-GENERAL CORPORATION, PROPULSION DIVISION. GENENTECH INC SUBJECT AMPOULES SODIUM THIOSULFATE MANUFACTURED IN INDIANAPOLIS. HYDROCORTISONE HEMISUCCINATE MICRO

4Q2012

AMINOPHYLLINE,ANHYDROUS(THEOPHYLLINE ETHYLENEDIAMINE,ANHYDROUS) DEXAMETHASONE SODIUM PHOSPHATE CYCLOTRON FACILITY-MARYLAND HEIGHTS, MO. PERSONNEL QUALS LISTINGS FOR 3 SUBSIDS IN SWORDS, DUBLIN, IRELAND AMINOPHYLLINE, HYDROUS (THEOPHYLLINE ETHYLENEDIAMINE, HYDROUS) ZINC INSULIN CRYSTALS AS MANUFACTURED IN MONTES CLAROS MG BRAZIL. THEOBID & THEOBID JR. S.R. CAPS 130MG & 260MG-MANUF FOR GLAXO LABS INC THEOPHYL S.R. CAPS 125MG & 250MG (THEOPHYLLINE)-FOR KNOLL PHARMA CO. PERSONNEL, FACILS, & GEN OPER PROCEDS FOR ELKHART, IN LOCATION ZOMEPIRAC SODIUM DIHYDRATE OXTRIPHYLLINE (CHOLINE THEOPHYLLINATE) L-THREONINE (PYROGEN FREE) TESTOSTERONE HETOXOL D(CETEARYL ALCOHOL&CETEARETH-20) MNFG IN PATERSON,NJ FACILITY BETA-ESTRADIOL L-SERINE (PYROGEN FREE) CLORAZEPATE DIPOTASSIUM, BULK FORM HYDROCORTISONE 17-VALERATE (THIS DFORMERLY HELD BY S.I.R.S) BETAMETHASONE 17-BENZOATE MNFG BY VISTER S.P.A.(ITALY)(FACIL.OF PD/WL L-VALINE, PYROGEN FREE-MFGR BY REXIM S.A., DIV. OF DEGUSSA, HAM FRANCE FORMULATIONS FOR MOLDED RUBBER COMPOUNDS, PARCO 4418-70 MANUF. METHODS AND CONTROLS FOR BULK LEAD 201 & THALLIUM 201 FACILITIES AND KEY PERSONNEL INCLUDING DRUG QUALITY PROCEDS. MANUAL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SOUTH SAN FRANCISCO. E-Z SCRUB W/HIBICLENS (CHLORHEXIDINE GLUCONATE) MANUFACTURED BY DESERET CO IN UTAH. L-ALANINE (PYROGEN FREE) ADHESIVES AS USED IN TRANSDERMAL DRUG DELIVERY MFG IN PA. FACILS PERSONNEL, FACILITIES AND GENERAL OPERATING PROCEDURES ZOMEPIRAC SODIUM DIHYDRATE L-LYSINE HYDROCHLORIDE PYROGEN FREE EMPTY GELATIN CAPSULES AS MFG. IN PONTYPOOL, UNITED KINGDOM UNION CARBIDE'S SENTRY SIMETHICONE USP & 30% EMUL.-MFG SISTERVILLE, WV PALAINOL PLASTICIZERS--HAS BEEN SOLD AND SHOULD BE DISCN PER CORRES FACILS & CONTROLS FOR THE MANATI, PUERTO RICO LOCATION

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4Q2012EXCEL DMF# 3996 3997 3998 3999 I 4000 4001 4002 4003 4004 I 4005 4006 I 4007 4008 4009 4010 I 4011 4012 4013 4014 4015 4016 I 4017 4018 4019 4020 4021 4022 4023 4024 4025 4026 4027 I 4028 4029 4030 4031 C I A I II II V II 12/10/1980 1/6/1981 11/21/1980 12/19/1980 TEVA PHARMACEUTICAL INDUSTRIES LTD DEGUSSA AG JUBILANT HOLLISTERSTIER LLC SOCIETA ITALIANA CORTICOSTEROIDI SPA I I I I I I I I I I II II II II III II II II II II V 12/10/1980 11/11/1980 11/19/1980 2/6/1981 11/7/1980 1/5/1981 1/9/1981 1/6/1981 1/6/1981 1/8/1981 10/8/1980 I I I I A II II II III II II 9/25/1980 12/15/1980 12/15/1980 12/18/1980 11/19/1980 11/27/1980 CALBIOCHEM-BEHRING CORP LONZA INC KNOLL AG LUDWIGSHAFEN HS CROCKER COMPANY INC EVONIK CORPORATION RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA 3M PHARMS PFIZER LTD DEGUSSA AG ER SQUIBB AND SONS INC INTEX PLASTIC SALES CO SIGMA F AND D DIV LTD FERMION OY DEGUSSA AG SIGNA SA DIOSYNTH BV STERIGENICS INTERNATIONAL L-ALPHA-LECITHIN, BETA, GAMMA-DIPALMITOYL A I I III II II II 12/8/1980 12/5/1980 11/12/1980 11/26/1980 I II I 11/26/1980 12/8/1980 I A I I III IV II IV II 12/8/1980 12/1/1980 11/10/1980 10/30/1980 12/5/1980 INMONT CORP CAPSUGEL DEGUSSA CORPORATION CALBIOCHEM-BEHRING CORP COMPANIA ESPANOLA DE SINTESIS QUIMICA SA MEDIMPEX NORTHAMERICA INC BOEHRINGER INGELHEIM PHARMACEUTICALS INC RICHMOND TECHNOLOGY INC ER SQUIBB AND SONS INC DEGUSSA AG MEDIMPEX NORTHAMERICA INC STATUS Type SUBMIT DATE I I I II II II I 12/3/1980 12/9/1980 11/10/1980 11/14/1980 HOLDER PFANSTIEHL LABORATORIES INC NV ORGANON DEGUSSA AG ORMONT DRUG AND CHEM CO INC SUBJECT THERAFECTIN, PRODUCT CODE # T-124 PIPERAZINE ESTRONE SULPHATE L-ARGININE HCL AS MANUF BY REXIM S.A. DIV OF DEGUSSA IN HAM, FRANCE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. DRUM LININGS AS MANUF IN THE OHIO FACILIS: 4A DRUM LINING (66) GELATIN CAPSULES MANUFACTURED IN PUEBLA, MEXICO L-ASPARTIC ACID AS MANUF BY REXIM S.A. DIV DEGUSSA IN HAM, FRANCE

4Q2012

EGG YOLK PHOSPHATIDES (TYDOL)TM - AS PRODUCED IN CALIFORNIA FACILS BETAMETHASONE BASE USP XX MANUF BY CESQUISA OF SPAIN GLUETHIMIDE MANUF BY CHEM WORKS OF GEDEON RICHTER, LTD. HUNGARY PRODUCTION AND DISTRIBUTION FACILITY IN DANBURY, CONNECTICUT THERMOPLASTIC FILMS AND SHEETS DESONIDE L-LEUCINE AS MANUF BY REXIM S.A. DIV. DEGUSSA IN HAM, FRANCE NANDROLONE PHENYLPROPIONATE MANUF-BY CHEM WORK OF GEDEON RICHTER LTD.

CHLORHEXIDINE GLUCONATE, 20% SOLUTION, BP 73 & CHLORHEXIDINE DIACETATE CHOLINE THEOPHYLLINATE (OXTRIPHYLLINE) ADHESIVES IN THE CXL SERIES AS MANUF IN THE ILLINOIS FACILS L-GLUTAMIC ACID AS MANUF BY REXIM S.A. DIV. DEGUSSA IN HAM, FRANCE DIPYRIDAMOLE ISOPRENALINE (ISOPROTERENOL) AND ITS SALTS METHOTREXATE AS MANUFACTURED IN SANDWICH, KENT,ENGLAND L-ISOLEUCINE AS MANUF BY REXIM S.A. OF DEGUSSA IN HAM, FRANCE FLUPHENAZINE DECANOATE AND FLUPHENAZINE ENANTHATE RIGID PVS PACKAGING MATERIALS: INTEX 15001 PHENOLPHTHALEIN GLUCURONIC ACID ACETONIDE HYDROLYSATE CODE 2543 L-PHENYLALANINE AS MANUF BY REXIM S.A. DIV. OF DEGUSSA IN HAM, FRANCE CRUDE METRONIDAZOLE HYDROCORTISONE SODIUM PHOSPHATE STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN TUSTIN, CA HYDROCHLOROTHIAZIDE L-METHIONINE AS MANUF BY REXIM S.A. DIV. OF DEGUSSA IN HAM, FRANCE SVP FACILITY (ESUB) HYDROCORTISONE-17-BUTYRATE

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4Q2012EXCEL DMF# 4032 4033 4034 4035 4036 4037 4038 4039 I 4040 4041 4042 4043 I 4044 I 4045 4046 4047 4048 4049 4050 4051 4052 4053 4054 4055 4056 4057 4058 4059 I 4060 4061 4062 4063 I 4064 4065 4066 4067 I A A I II II II II 2/2/1981 2/20/1981 1/21/1981 1/21/1981 I I A II II IV I 2/17/1981 2/6/1980 1/13/1981 12/23/1980 I I I I I I A I I I I I I I II II III II I II II II II II II II III II II 1/16/1981 10/3/1980 1/6/1981 1/1/1981 12/24/1980 1/14/1981 2/5/1981 1/28/1981 1/28/1981 2/9/1981 2/10/1981 1/29/1981 1/27/1981 1/23/1981 1/29/1981 II 12/5/1980 I I I II II I II 12/10/1980 10/22/1980 12/24/1980 12/31/1980 STATUS Type SUBMIT DATE I I I I I I A II II II II II I II II 12/23/1980 10/22/1980 1/16/1981 1/6/1981 12/18/1980 12/24/1980 1/20/1981 4/22/1980 HOLDER GANES CHEMICALS INC AMINO GMBH MALLINCKRODT CHEMICAL INC DEGUSSA AG ORION CORP FERMION TANABE SEIYAKU CO LTD SIEGFRIED AG ZENECA PHARMACEUTICALS DIV ZENECA INC TEVA PHARMACEUTICAL INDUSTRIES LTD AMINO GMBH TANABE SEIYAKU CO LTD SHANSHI PHARMACEUTICAL INDUSTRY CORPORATION SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT DIOSYNTH BV HOPE CO MLI ACQUISITION CORP II MEDIMPEX NORTHAMERICA INC TANABE SEIYAKU CO LTD MALLINCKRODT INC SANOFI CHIMIE CYCLO PRODUCTS INC SIGMA F AND D DIV LTD HEXAGON LABORATORIES INC EGIS PHARMACEUTICALS BRISTOL MYERS SQUIBB COMPANY VACUMET CORP SIEGFRIED LTD MALLINCKRODT PHARMS DIV MALLINCKRODT INC MEDIMPEX NORTHAMERICA INC HOFFMANN LA ROCHE INC SOLAE LLC SHANGHAI FOURTH PHARMACEUTICALS LTD SIGMA F AND D DIV LTD BASF PHARMA EVIONNAZ SA GEDEON RICHTER LTD JAMES RIVER CORPORATION SUBJECT DYCLONINE HCL L-PHENYLALANINE POTASSIUM NITRATE TAC AS MANUF IN THE ST. LOUIS MISSOURI FACILS. L-TRYTOPHAN AS MANUF BY REXIM S.A. DIV OF DEGUSSA IN HAM, FRANCE METHOCARBAMOL NF XV

4Q2012

FACILS., PERSONNEL & GENERAL OPERATING PROCEDS-OF TOKYO,JAPAN PLANT CARBATCHOL-AS MANUF & SOLD UNDER SIEGFRIED LABEL POLYOXYETHYLENE FA. ACID ESTERS-MFG BY ALAS CHEM GERMANY ACETYLSULFISOXAZOLE L-ISOLEUCINE FACILS.,PERSONNEL, & GENERAL OPERATING PROCEDS-OF OSAKA, JAPAN PLANT MEPROBAMATE-PRODUCED BY SHANSHI CORP IN TAIYUAN, PEOPLES' REPUB CHINA) TENIPOSIDE (VM 26) PREGNENOLONE HEMISUCCINATE BULK SULFAMETHAZINE AND SODIUM SULFAMETHAZINE PRESSURE SENSITIVE LAMINATES - FACILS & CONTROLS A ST. ALBANS VT PREDNISOLONE AS MANUF BY CHEM WORKS OF GEDEON RICHTER, LTD. BUDAPEST FACILS.,PERSONNEL, & GENERAL OPERATING PROCEDS-ONODA, JAPAN PLANT PRODUCTION OF TALLOUS T1-201 CHL A THE BURLINGAME, CA PREDNISOLONE SODIUM PHOSPHATE ISOXSUPRINE HCL AS MANUF IN THE LOS ANGELES CALIFORNIA FACILITIES L-TYROSINE ZOMEPIRAC SODIUM DIHYDRATE AS MANUF IN THE BRONZ NEW YORK LOCATION CYPROHEPTADINE HCL AS MANUF BY EGYT PHARMACOCHEMICAL WORKS JM-9 FOR INJECTION AS MANUF IN THE SYRACUSE, N.Y. FACILITIES METALLIZED POLYESTER FILMS AS MANUF IN THE WAYNE NJ FACILS: BARRIERMET PHENAZOPYRIDINE HCL AS MANUF & SOLD UNDER THE SIEGFRIED LABEL DOXYLAMINE SUCCINATE USP AS PRODUCED IN THE ST. LOUIS MO PLANT FURAZOLIDONE AS MANUF BY CHINOIN PHARMACEUTICAL & CHEMICAL WORKS, LTD. RO 20 5933 AS MANUF IN THE NEW JERSEY FACILITIES ( INJECTABLE) EMCOSOY AS MANUFACTURED IN OKLAHOMA AND TENNESSEE FACILITIES AND CONTROLS DEUTERIUM OXIDE TETRACAINE HCL ESTRADIOL MNFG IN BUDAPEST SODIUM CELLULOSE PHOSPHATE (SCP) AS MANUF ON THE N.H. FACILS

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4Q2012EXCEL DMF# 4068 I 4069 4070 4071 I 4072 4073 4074 4075 I 4076 4077 4078 4079 4080 4081 4082 I 4083 I 4084 4085 4086 4087 4088 4089 I 4090 4091 4092 4093 4094 4095 4096 I 4097 4098 I 4099 I 4100 4101 I I II II 3/6/1981 3/26/1981 GLAXOSMITHKLINE KYOWA HAKKO KOGYO CO LTD 7-ACA TOSYLATE AS MANUFACTURED IN ULVERSTON PLANT L-MALIC ACID III 3/6/1981 A II II 2/24/1981 3/13/1981 I I I I I A I II II II I II II 3/13/1981 3/4/1981 2/25/1981 3/25/1981 3/6/1981 2/27/1981 2/20/1981 HOECHST MARION ROUSSEL SA ORGAMOL SA DANISCO INGREDIENTS HOFFMANN LA ROCHE INC GLAXO WELLCOME INC SANOFI AVENTIS CHIMIE I I I I A II II I III II I 2/26/1981 3/3/1981 2/27/1981 2/25/1981 2/27/1981 3/9/1981 EGIS PHARMACEUTICALS PUBLIC LTD CO ROUSSEL-UCLAF COSMA SPA MONSANTO COMPANY SIEGFRIED LTD STERLING ORGANICS I 3/16/1981 I I I I I I I II II II III II I 12/22/1980 2/18/1981 2/18/1981 1/21/1981 2/19/1981 3/3/1981 3/13/1981 I I I III II II III 11/18/1981 1/21/1981 1/20/1981 12/10/1980 NORTH CHEMICAL COMPANY INC MEDIMPEX NORTHAMERICA INC FOURTH PHARMACEUTICAL WORKS EQUISTAR CHEMICALS LP SUB LYONDELLBASELL JOHNSON AND JOHNSON GMBH DIOSYNTH BV RHONE POULENC INC LONZA INC B BRAUN MEDICAL INC ROUSSEL-UCLAF ENGELHARD MINERALS AND CHEMICAL CORP R P SCHERER I I I II I 2/10/1981 2/17/1981 1/26/1981 STATUS Type SUBMIT DATE II 1/30/1981 HOLDER SOCIETA ITALIANA MEDICINALI SCANDICCI (SIMS) REHEIS CHEM CO DIV ARMOUR AND CO DIOSYNTH INC ANTIBIOTICOS SPA SUBJECT FACILITIES AND CONTROLS FOR THE PRODUCTION OF MEFENAMIC ACID

4Q2012

PERSONNEL & GEN OPER PROCEDS FOR THE BERKELEY HEIGHTS, NJ LOCATION HEPARIN SODIUM (CRUDE) FROM BEEF LUNGS AS MANUF IN THE CHICAGO,ILL FAC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RODANO, ITALY. COLLOID 581B AS MANUF IN THE MARIETTA, GEORGIA FACILITIES ESTRADIOL DIPROPIONATE AS MANUF BY CHEM WORKS OF GEDEON RICHTER, LTD. DIPHENHYDRAMINE, BULK FORM (SYNTHESIS) POLYPROPYLENE RESINS FACILITIES AND PROCEDURES FOR THE MANUF. OF TAMPONS HEPARIN SODIUM TRIMIPRAMINE MALEATE AS MANUF IN THE NEW BRUNSWICK, NJ PLANT CHLORHEXIDINE HCL B.P. 73 PARENTERAL DRUGS IN PLASTIC CONTAINERS TRIAMCINOLONE FACILS & GEN OPERT. PROCEDS AT THE EDISON,NJ FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ST. PETERSBURG, FLORIDA. ALLOPURINOL AS MANUF BY EGYT PHARMACOCHEMICAL WORKS TRIAMCINOLONE ACETONIDE PERSONNEL, FACILITIES AND GENERAL OPERATING PROCEDURES CARBETHIMER (N-137)(CARBETIMER) BULK FORM-MANUF IN DAYTON,OH. FACILS TRIMETHOBENZAMIDE HCL. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN UNITED KINGDOM. FACILS & GENERAL OPERATING PROCEDS AT NEUVILLE-SUR-SAONE LOCATION SALICYLAZOSULFAPYRIDINE (SULFASALAZINE) MEPROBAMATE RO 21-5535 (CALCITRIOL) AMPULS 2.5 MCG/0.5ML-MANUF IN NJ FACILITIES FACILS AND GEN OPER PROCEDS AT THE ULVERSTON PLANT CYANOCOBALAMIN MANUFACTURED IN ELBEUF, FRANCE

CIBA PHARMACEUTICAL CO DIV CIBA GEIGY TRAFURIL(THURFYL NICOTINATE)MNFG BY CIBA LABS,TESTED IN BASIL CORP BASF PHARMACHEMIKALIEN GMBH CO KG THEOPHYLLINE ENGELHARD MINERALS AND CHEMICAL CORP OLIN CORP CISPLATIN-MANUF IN EDISON, NEW JERSEY NITROCELLULOSE&POLYMER(SARAN)COATED SERIES:HEAT SEALABLE CELLOPHANES

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4Q2012EXCEL DMF# 4102 4103 4104 4105 4106 4107 4108 I 4109 4110 I 4111 4112 4113 I 4114 I 4115 I 4116 I 4117 I 4118 4119 4120 4121 4122 4123 4124 I 4125 4126 4127 4128 4129 4130 4131 I 4132 4133 4134 A I I II I II 4/20/1981 4/21/1981 3/31/1981 H REISMAN CORP WHEATON CLOSURES INC MALLINCKRODT INC I A I A I A II II III II II II I 2/28/1981 2/27/1981 11/20/1986 3/31/1981 4/7/1981 2/27/1981 4/20/1981 YAMASA SHOYU COMPANY LTD TRIFARMA SPA CP HALL CO MALLINCKRODT INC DIOSYNTH BV TRIFARMA SPA GD SEARLE AND CO A I A I I I II II II II II II I 4/9/1981 4/1/1981 2/27/1981 4/1/1981 4/7/1981 4/14/1981 4/7/1981 TEVA PHARMACEUTICAL INDUSTRIES LTD CHUGAI PHARMACEUTICAL CO LTD TRIFARMA SPA SIGMA F AND D DIV LTD DIOSYNTH BV ROCHE PRODS LTD HOECHST AG I 4/10/1981 I 3/18/1981 CRISPEN LABORATORIES & ASCOT INJECTABLES SYNCOR INTERNATIONAL CORP I 3/5/1981 NORDION INTERNATIONAL INC I 2/28/1981 I I II II II 3/27/1981 3/20/1981 3/25/1981 I II II 3/23/1981 3/17/1981 ORGANICHEM CORP TIANJIN MEDICINES & HEALTH PRODUCTS IMPORT AND EXPORT CO KNOLL AG LUDWIGSHAFEN CALBIOCHEM-BEHRING CORP INTERNATIONAL MINERALS & CHEMICAL CORP YAMASA SHOYU COMPANY LTD STATUS Type SUBMIT DATE I I A I I I II III II III I II I 2/23/1981 12/24/1980 2/27/1981 3/4/1981 3/6/1981 3/3/1981 3/22/1981 HOLDER SCHERING AG TSCHEULIN ROTHAL GMBH COSMA SPA 3M PHARMS GLAXO WELLCOME INC SOCIETA ITALIANA CORTICOSTEROIDI SPA ETHYL CORP SUBJECT NANDROLONE DECANOATE

4Q2012

ALUMINUM FOILS & PVDC COATED PVC FILMS FOR PHARMACEUTICAL PACKAGING PROPRANOLOL HCL (ESUB) AS MANUFACTURED IN CISERANO, ITALY HEA-SEALABLE MICROPORUS TAPES, CORDOVA, ILLINOIS CEPHALOSPORINS FILLING UNIT LOC IN BERNARD CASTLE, COUNTY DURHAM ENG. FLURANDRENOLIDE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES BATON ROUGE, LOUISANA. TOLMETIN SODIUM DIHYDRATE AS MANUF IN THE RENSSALATER NY FACILITY METHOCARBAMOL MFG BY XIN XIN PHARMACEUTICAL MANUFACTORY DIPHENHYDRAMINE HCL GRINDING OF SODIUM BISULFITE (LA JOLLA, CALIF. PLANT) PENTAERYTHRITOL(PETN) MFGR IN SPANISH FORK, UTAH FACILS.(BULK) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CHOSHI. MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES, AND PERSONNEL IN VANCOUVER OPERATIONS. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MELROSE PARK, ILL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SYLMAR, CALIFORNIA. BETAMETHASONE VALERATE SG-75 (N-(2-HYDROXYETHYL) NICOTINAMIDE NITRATE TABS THIORIDAZINE HYDROCHLORIDE YOHIMBINE HYDROCHLORIDE HYDROCORTISONE SODIUM SUCCINATE RO 12-1989 (DIHOMO-GRAMMA-LINOLENIC ACID)-MFGR BY ROCHE PRODS.,LTD MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FRANKFURT. URIDINE, 5-BROMO-2' -DEOXY.THIS INFO WAS SUBMITTED NCI/NIH FLUPHENAZINE HCL MONOPLEX S-75 (DFORMERLY HELD BY ROHM AND HAAS COMPANY) THALLOUS CHLORIDE TI 201 (ESUB) HEPARIN CALCIUM PERPHENAZINE U.S.P. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MT. PROSPECT, ILL.LOCATION. PSEUDOEPHEDRINE HCL; BULK PSEUDOEPHEDRINE HCL FACILITIES,CONTROLS & PERSONNEL MILLVILLE, NJ GALLIUM CHL GA-67 (ESUB) AS MANUFACTURED IN MARYLAND HGTS., MISSOURI CYCLOTRON FACILITY

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4Q2012EXCEL DMF# 4135 I 4136 4137 4138 4139 4140 4141 4142 I 4143 I 4144 4145 4146 4147 4148 4149 4150 4151 I 4152 4153 4154 4155 4156 I 4157 4158 I 4159 4160 4161 4162 4163 4164 4165 I 4166 4167 I 4168 I II 5/7/1981 I III I 5/13/1981 3/31/1981 EKA NOBEL INC PAPER CHEMICALS DIV PROFARMACO SRL I A I I I A I III II III III III I 5/21/1981 4/23/1981 4/29/1981 5/1/1981 4/29/1981 4/30/1981 5/21/1981 SCHERING PLOUGH AVONDALE CO EASTMAN CHEMICAL CO CENTRAL PHARMACEUTICALS INC TECNOCAP LLC FLEXEL INC BARNHARDT MANUFACTURING CO IRISH FINE CHEMICALS LIMITED I I I 2/18/1981 5/11/1981 GAELEO LTD MEIJI SEIKA KAISHA LTD I I I I I I II I I 5/7/1981 5/1/1981 4/28/1981 5/5/1981 4/17/1981 INDUSTRIA FARMACEUTICA SERONO DENKA PHARMCEUTICAL CO LTD GRINDSTED PRODUCTS LYPHOMED INC VANGARD LABS DIV MIDWAY MED CO I I I I A I I II II II III II I II I 4/16/1981 4/6/1981 1/31/1981 1/23/1981 4/28/1981 4/8/1981 5/5/1981 5/7/1981 II 4/13/1981 IMC CHEMICAL GROUP INC SUB INTL MINERALS & CHEM CORP GANES CHEMICALS INC CAMBREX PROFARMACO MILANO SRL US COTTON LLC WACKER CHEMIE GMBH TEVA PHARMACEUTICAL INDUSTRIES LTD GEDEON RICHTER DIOSYNTH BV CCL CUSTOM MANUFACTURING INC I I I A I I II II II II II II I 4/14/1981 3/23/1981 4/23/1981 3/27/1981 3/3/1981 3/24/1981 3/16/1981 PERKINS ELMER LIFE SCIENCES ETHYL CORP SIGMA F AND D DIV LTD SIMS SRL PROFARMACO SRL MAY AND BAKER LTD SMITH LABORATORIES INC STATUS Type SUBMIT DATE I 2/27/1981 HOLDER INDUSTRIA CHIMICA MILANESE SPA SUBJECT MANUFACTURING SITE, PERSONNEL, FACILITIES, AND GENERAL OPERATING PROCEDURES AT MILANO, ITALY. INDIUM-111 PRODUCED IN NORTH BILLERICA, MASS FACILITIES ZOMEPIRAC SODIUM DIHYDRATE PROCESSED MD UNIT, BATON ROUGE, LA DIMETHYL SULFOXIDE LIDOCAINE BASE CRYSTALLIZED & LIDOCAINE HCL LIDOCAINE HCL & BASE---2-(DIETHYLAMINO)-2-6 ACETOXYLIDIDE HCL ACEBUTOLOL HCL/SECTRAL MANUFACTURING SITE, FACILITIES,PERSONNEL, AND GENERAL OPERATING PROCEDURES . ERYTHRITOL TETRANITRATE(ETN) MNFG IN SPANISH FORK, UTAH FACILITIES

4Q2012

FLUTAMIDE-MANUF IN CARLSTADT,NJ--CUSTOM BASIS FOR SCHERING PLOUGH CORP NAPROXENE NICLOSAMIDE VINNOL H 70 DF BETAMETHASONE DIPROPIONATE FOR CHEMICAL WORKS OF GEDEON RICHTER, LTD -BUDAPEST PREDNISOLONE SUCCINATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DANVILLE, ILL. FACILITIES, CONTROLS & PROCEDURES FOR MANUF OF ANTI-HCG MANUF PROCEDS HUMAN CHORIONIC GONADOTROPIN (HCG) SULFAMETHAZINE MANUF. PROCEDS FOR OXYTOCIN INJECT (BULK)--IN CHICAGO, ILL. FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GLASGOW, KENTUCKY. METHODS, FACILS. & CONTROLS FOR THE MFGR OF POLYESTRADIOL PHOSPHATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ASHIGARA, JAPAN. RAHDRUM, COUNTY WICKLOW, IRELAND ECDEL ELASTOMERS AS MANUFACTURED AT TENNESSEE EASTMAN DIVISION PSEUDOEPHEDRINE HCL CAPS 120MG--AS MFGR IN SEYMOUR, IND.,FACILS. PACKAGING MATERIALS-CLOSURES MANUFACTURED IN BROOKLYN, NEW YORK. NITROCELLULOSE & POLYMER COATED CELLOPHANES-MFGR COVINGTON, IND. FACIL COTTON & RAYON COILERS MANUFACTURED IN DAYVILLE, CONNECTICUT. MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN RAHDRUM, IRELAND. BEROCELLS DEBONDING AGTS FOR PROCESS FLUFF PULPS: MANUF SWEDEN

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. PLIVA PHARMACEUTICAL CHEMICAL FOOD & GLUTETHIMIDE (CHEM NAME: 2-ETHYL-2-PHENYL GLUTARIMIDE) COSMETIC INDUSTRY

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4Q2012EXCEL DMF# 4169 4170 I 4171 4172 I 4173 I 4174 4175 I 4176 I 4177 4178 4179 4180 I 4181 4182 4183 I 4184 I 4185 4186 4187 4188 I 4189 4190 4191 4192 4193 I 4194 4195 4196 I 4197 I 4198 I 4199 I III 5/22/1981 I 6/1/1981 II 6/30/1981 COMPANIA ESPANOLA DE SINTESIS QUIMICA SA ABBOTT LABORATORIES HOSP PRODUCTS DIV OLIN CORP I A II II I 5/29/1981 5/11/1981 5/28/1981 I A I A II III II IV II 5/26/1981 6/22/1981 6/24/1981 6/18/1981 6/11/1981 SALK INSTITUTE B BRAUN MEDICAL INC BIOCHEMIC GESELLSCHAFT MBH ASAHI KASEI FINECHEM CO LTD A I A II II II I 5/27/1981 6/12/1981 6/23/1981 6/18/1981 I 5/29/1981 ABBOTT LABORATORIES HOSP PRODUCTS DIV BASF PHARMACHEMIKALIEN GMBH CO KG PHARMACO LABORATORIES INC NAPP CHEMICALS INC ASAHI CHEM INDUSTRY CO LTD I I II II I 6/10/1981 6/23/1981 5/7/1981 A A I III II II I 5/8/1981 5/21/1981 5/1/1981 6/1/1981 I 5/7/1981 I I II 5/28/1981 5/4/1981 I 5/29/1981 I II II 4/6/1981 5/21/1981 G POHL BOSKAMP GMBH AND CO STUART PHARMACEUTICALS DIV ICI AMERICAS ABBOTT LABORATORIES HOSP PRODUCTS DIV MARION LABORATORIES INC ONCOLOGY RESEARCH & DEVELOPMENT INC SCHERING CORP SUB SCHERING PLOUGH CORP HOSPIRA INC BAYER PHARMA AG CILAG CHEMIE AG ABBOTT LABORATORIES HOSP PRODUCTS DIV DIOSYNTH BV NAPP CHEMICALS INC SISA INC STATUS Type SUBMIT DATE I III I 5/20/1981 5/21/1981 HOLDER BAXTER HEALTHCARE CORP BRYAN LOFTUS SUBJECT

4Q2012

PRODUCTION OF PARENTERAL INJ. - PLASTIC CONTAINERS(PL-146) CAROLINA PR MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RAHDRUM, CO WICKLOW IRELAND. NITROGLYCERINE PRODS, NITROLINGUAL SPRAY IN PARTICULAR. IND 18-483 SDM 50 (STABILIZED 50/50 ISOSORBIDE DINITRATE-LACTOSE MIXTURE) STD TEST METHODS FOR TESTING SVP & LVP PRODUCTS(PERIOD 5-1-80 - 5-1-81 RESEARCH & DEVELOPMENT FACILS AT THE KANSAS CITY MISSOURI LOCATION HEMATOPORPHYIN DERIVAIVE (PHOTOFIN) FOR HUMAN USE--CHEEKTOWAGA, NY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MANATI, PUERTO RICO. CR3 FLEXIBLE CONTAINER AS MANUF IN NORTH CHICAGO, ILL FACILITIES LEVONORGESTREL (ESUB) AS MANUFACTURED IN BERGKAMEN, GERMANY ZOMEPIRAC SODIUM DIHYDRATE STANDARD TEST METHODS FOR TESTING SVP & LVP PRODUCTS (5-1-80 - 5-1-81) CORTICOTROPIN LIDOCAINE HCL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CAMBRIDGE, MASSACHUSETTS. STD.CONTROL PROCEDURES,RAW DRUG CODES FOR SVP & LVP PRODUCTS(5-80 5-81 PSEUDOEPHEDRINE HCL AS MANUFACTURED IN MINDEN, GERMANY METHDILAZINE--A THE TITUSVILLE, FLA. LOCATION SILVER SULFADIAZINE MANUF. AT LODI, NJ 07644 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. 4F-ANTAGONIST PACKAGING MATERIAL (ESUB) MANUFACTURED IN IRVINE CA OXYTOCIN SOLUTION 200 I.U./ML REFINED EGG PHOSPHATIDE

ABBOTT LABORATORIES PHARMACEUTICAL SELENIUM SULFIDE AS MANUF IN NORTH CHICAGO ILL, FACILITIES PRODUCTS DIV TANABE SEIYAKU CO LTD AMINO ACID MIXTURE ABBU CAMBREX PROFARMACO MILANO SRL PFIZER INC LORMETAZEPAM MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PARSIPPANY, NEW JERSEY. TRIAMCINOLONE ACETONIDE USPXX STD CONTROL PROCEDURES,RAW DRUG CODES FOR SVP & LVP PRODUCTS,5-80 5-81 LAMINA. OF CELLOPHANE W/ALUM. FOIL OR POLYPROPYLENE FILM, N.C. LOCA

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4Q2012EXCEL DMF# 4200 4201 I 4202 4203 A 4204 4205 4206 4207 4208 4209 I 4210 4211 4212 4213 4214 I 4215 4216 4217 4218 4219 I 4220 4221 I 4222 I 4223 4224 4225 4226 4227 4228 4229 4230 4231 A 4232 4233 I A II II 6/25/1981 4/8/1981 I I I I I I I I I II II II III II I II II 7/21/1981 7/22/1981 6/24/1981 6/12/1981 5/28/1981 7/28/1981 7/21/1981 6/15/1981 6/16/1981 B BRAUN MEDICAL INC SANOL-SCHWARZ HOFFMANN LA ROCHE INC LINSON LTD BORDEN CHEM CO STEROID SRL MCGAW INC SIEGFRIED AG PERKINELMER LIFE ANALYTICAL SCIENCES INC PIERCE CHEM CO PHARMACIA AND UPJOHN SUB PFIZER INC I 7/20/1981 PFANSTIEHL LABORATORIES INC A II I 3/18/1981 6/30/1981 ESTEVE QUIMICA SA HOVIONE SOCIEDADE QUIMICA LDA I I I I II I II II I 6/30/1981 7/22/1981 5/14/1981 6/15/1981 7/15/1981 KV PHARMACEUTICAL CO SANOL-SCHWARZ FALK GMBH AND CO ORION CORP LTD FERMION JOHNSON AND JOHNSON MEDICAL INC I I I I I II II II I 7/16/1981 6/12/1981 7/17/1981 6/5/1981 5/19/1981 AH ROBINS CO FERMION OY LONZA RIVERSIDE BIOCHEMIC GESELLSCHAFT MBH CYANAMID GREAT BRITAIN LTD I I I I I II II II II II I 6/19/1981 5/5/1981 7/8/1981 7/3/1981 7/8/1981 7/9/1981 H REISMAN CORP FABBRICA ITALIANA SINTETICI POLYSCIENCES INC DIOSYNTH BV SIGMA F AND D DIV LTD LAPORTE ORGANICS FRANCIS SPA I II II 5/29/1981 6/12/1981 TANABE SEIYAKU CO LTD MALLINCKRODT INC STATUS Type SUBMIT DATE I II I 6/10/1981 6/5/1981 HOLDER DIOSYNTH BV UDL LABORATORIES INC SUBJECT METOCURINE IODIDE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ROCKFORD, ILLINOIS. AMINO ACID MIXTURE ABBX

4Q2012

COMPAP (ESUB) AS MANUFACTURED IN THE RALEIGH, NORTH CAROLINA FACILITIES PSEUDOEPHEDRINE SULFATE, BULK FORM MFG. ORANGE, NEW JERSEY FACILITIES TRIMETHOPRIM USP, BULK FORM INDICINE-N-OXIDE TRIAMCINOLONE DIACETATE ADENOSINE, SIGMA GRADE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. PLANT MASTER FILE FOR ARECIBO, PUERTO RICO LOCATION SULPHINPYRAZONE USP 80 AURANOFIN PLEUROMULIN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GOSPORT. DIDRONEL TABLETS, 200 MG, MNFG IN WESTPORT FACIL., ST.LOUIS, MISSOURI PERSONNEL,FACILITIES AND GENERAL OP. PROCEDURES, MONHEIM FACIL. URSODEOXYCHOLIC ACID (URSOFALK CAPS) CHLORHEXIDINE ACETATE BP 80 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDUES IN GURABO, PUERTO RICO. INDOMETHACIN FOR HUMAN USE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WAUKEGAN, ILLINOIS. FACILITIES & GENERAL OPERATING PROCEDS AT IRVINE, CALIF ISOSORBIDE DINITRATE TRANSDERMAL SUSPENSION RO 5-9963 (DESMETHYLMISON IDAZOLE--MFGR BY HOFFMANN LA ROCHE AG. SWITZ BENDROFLUMETHIAZIDE (BULK)--MFG BY LINSON, LTD, SWORDS, DUBLIN,IRELAND CASCO FLEX ADHESIVE IN THE NT SERIES MFG A DELAWARE, OH FACIL NANDROLONE DECANOATE (USAN) FACIL & GENERAL OPER PROCEDS AT MILLEDGEVILLE, GA LOCATION OXYMETAZOLONE HCL (BULK) AS MFG & SOLD UNDER SIEGFRIED LABEL IODINE-131-PRODUCED IN NORTH BILLERICA, MA. DIMETHYL ADIPIMIDATE HCL AS MFG IN ROCKFORD, ILL FACILITIES TESTOSTERONE PROPIONATE AS MFG IN THE MICHIGAN FACILITIES

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4Q2012EXCEL DMF# 4234 I 4235 4236 4237 4238 4239 4240 4241 4242 4243 I 4244 4245 4246 4247 4248 4249 4250 4251 4252 4253 4254 4255 4256 I 4257 4258 4259 4260 I 4261 4262 I 4263 4264 4265 I 4266 I 4267 4268 I I II I 9/3/1981 7/16/1981 DIOSYNTH BV PROCESSING COMPANY INC V 8/21/1981 PHARMACIA AND UPJOHN INC I I II II I 8/10/1981 9/4/1981 9/1/1981 SANOFI SA LONZA RIVERSIDE GRINDSTED PRODUCTS I II I 8/28/1981 8/25/1981 I A I II III II II 8/10/1981 7/30/1981 7/24/1981 8/28/1981 SANOFI SA STELMI SA TANABE SEIYAKU CO LTD RUETGERS-NEASE CHEMICAL COMPANY INC SIGMA F AND D DIV LTD CHIREX LTD I A A I I I I A I I I I II II II II II III II III II II II II I 7/31/1981 8/13/1981 8/6/1981 7/21/1981 7/20/1981 6/19/1981 8/6/1981 8/24/1981 8/10/1981 8/5/1981 8/5/1981 7/8/1981 8/25/1981 AMERSHAM RADIOCHEMICAL CENTER PHARMACIA AND UPJOHN SUB PFIZER INC FERMION OY PFANSTIEHL LABORATORIES INC ICI AMERICAS INC POLYMER CORP G POHL BOSKAMP GMBH AND CO DOW CHEMICAL CO SANOFI SA GANES CHEMICALS INC GLAXO OPERATIONS UK LTD ALPS PHARMACEUTICAL IND CO LTD SANOFI WINTHROP INC I I I I I A I A II II III III II II II II I 8/5/1981 8/6/1981 8/5/1981 11/11/1980 6/26/1981 6/26/1981 7/29/1981 8/12/1981 8/5/1981 STATUS Type SUBMIT DATE I 8/3/1981 HOLDER SUBJECT AYERST LABORATORIES INC DIV AMERICAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING HOME PRODUCTS CORP PROCEDURES IN ROUSES POINT, NEW YORK. TAIHO PHARMACEUTICAL CO INC FTORAFUR (ALSO CALLED FUTRAFUL OR TEGAFUR) G POHL BOSKAMP GMBH AND CO POLYMER CORP BASF AKTIENGESELLSCHAFT PHARMACIA AND UPJOHN INC CAMBREX PROFARMACO MILANO SRL GANES CHEMICALS INC ROCKWOOD LITHIUM INC GLAXO WELLCOME INC NITROLINGUAL CHEWABLE CAPSULE

4Q2012

POLYBOND ADHES. SYSTEMS IN THE GA-83 SERIES-MFG STAMFORD, CT. FACILS. LUPOLEN 1810 H WHITE 950/LUPOLEN 1800H NATURAL/POLYSTROL 143E WHT 200 TESTOSTERONE ENANTHATE USP AS MANUF IN THE MICHIGAN FACILITIES CLORAZEPATE DIPOTASSIUM BUSPIRONE HCL AS MFG IN CARLSTADT, NJ FACILS FOR THE MEAD JOHNSON CO LITHIUM CARBONATE AS MANUFACTURED IN KINGS MOUNTAIN, NC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MONTROSE, ANGEES, SCOTLAND. INDIUM IN 111 OXINE TESTOSTERONE CYPIONATE USP AS MFG IN THE MICHIGAN FACILITIES METHOTREXATE FTORAFUR (1-TETRAHYDRO-2-FURANYL) 5-FLUOROURACIL) PROD CODE #F-107 SDM 37 (ETHYL ALCOHOL-NITROGLY DRUG MIXTURE)-MFG REYNOLDS PLANT, PENN. POLYBOND ADHES. SYSTEMS IN THE PF-SERIES-MFG IN STAMFORD, CTPF-99 NITRONEL-GEL DOWLEX POLYETHYLENE RESINS CHLORAZEPATE MONOPOTASSIUM MFG FOR CLIN-MIDY AMITRIPYLINE BULK FORM AS MANUF - PENNSVILLE NJ FACILITIES DIONOSIL OILY (NDA 9-309) PHENYLPROPANOLAMINE HYDROCHLORIDE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FAWDON, NEWCASTLE TYNE NE3 3TT, ENGLAND. CLORAZEPATE DIPOTASSIUM MFG FOR CLIN-MIDY PACKAGING MATERIALS:ELASTOMERIC CLOSURES AND ITEMS AMINO ACID MIXTURE ABBC ZINC PYRION (TM)-MFG IN STATE COLLEGE, PENN. FACILS. DL-6,8-THIOTIC ACID, OXIDIZED FORM CLINICAL STUDIES BY DR. R. JACOBSON MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CRAMLINGTON, NORTHUMBERLAND, ENGLAND. MINAPRINE AS MFG BY SEMPA-CHIMIE FOR CLIN-MIDY PHENOXYBENZAMINE HCL AS MFG IN THE PA FACILITIES BULK VITAMINSFACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GRENNA, DENMARK STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN SCHAUMBURG,IL. ESTRADIOL VALERATE MICRO MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PARAMOUNT CALIFORNIA.

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4Q2012EXCEL DMF# 4269 4270 I 4271 I 4272 4273 A 4274 4275 4276 I 4277 4278 4279 4280 4281 4282 4283 4284 4285 I 4286 4287 4288 4289 I 4290 4291 4292 4293 I 4294 4295 I 4296 4297 4298 4299 4300 I 4301 4302 I I I II 10/27/1981 10/19/1981 I A I I II II II I I 8/28/1981 9/29/1981 10/22/1981 10/7/1981 8/14/1981 ORGANICHEM CORP LEK PHARMACEUTICALS DD SCHERING PLOUGH AVONDALE CO FLOW LABORATORIES INC SUPROFEN AS MFG IN RENSSELAER, NY FACILITIES SILVER SULFADIAZINE DEXCHLORPHENIRAMINE MALEATE I II II 9/29/1981 10/19/1981 SOCIETA ITALIANA CORTICOSTEROIDI SPA BETAMETHASONE NA PHOSPHATE HUHTAMAKI OY LEIRAS PHARMACEUTICALS DISOPYRAMIDE PHOSPHATE BULK FORM I I I II II I II 10/8/1981 9/25/1981 10/21/1981 9/29/1981 LUSOCHIMICA S P A TEVA PHARMACEUTICAL INDUSTRIES LTD BIOCRAFT LABORATORIES INC OXYMETAZOLINE HCL USP XX SULFAMETHOXAZOLE FOR NON-PENICILLIN PRODS FACILS A BANK STREET LOCATION I A I III II II II 9/9/1981 10/2/1981 10/4/1981 9/29/1981 I I I I I I I I II II II II II II I II II 9/8/1981 9/17/1981 9/23/1981 9/22/1981 9/23/1981 9/10/1981 8/31/1981 10/8/1981 10/2/1981 NV ORGANON SIGMA F AND D DIV LTD ROUSSEL-UCLAF GANES CHEMICALS INC INDUSTRIA FARMACEUTICA SERONO JT BAKER CHEMICAL CO SCHERING AG FOREST LABORATORIES INC COMPANIA ESPANOLA DE SINTESIS QUIMICA SA DEXTER CORPORATION MERCK KGAA SIFAVITOR SRL I I II II I 9/2/1981 8/21/1981 9/23/1981 PLANTEX LTD CHEM AND PHARM WORKS KV PHARMACEUTICAL CO INDUSTRIA FARMACEUTICA SERONO I II II 8/25/1981 7/15/1981 RHONE POULENC INC BAYER PHARMA AG I 9/10/1981 FH FAULDING & COMPANY LTD STATUS Type SUBMIT DATE I II I 8/31/1981 9/1/1981 HOLDER ROEHR CHEMICALS INC DANISCO INGREDIENTS SUBJECT PHENYLPROPANOLAMINE BASE AS MFG IN LONG ISLAND CITY,NY FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GRINSTED, DENMARK. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. SURICLONE (31, 264 R.P.)

4Q2012

TRASYLOL (APROTININ)-DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN WUPPERTAL, GERMANY HYDRALAZINE HCL U.S.P. MEDIGESIC PLUS CAPS--MFG IN ST. LOUIS, MO. FACILS FOR MEDICS PHARMACEU MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. TESTOSTERONE PROPIONATE GLUTAHIONE, FREE ACID REDUCED FORM PREDNISOLONE SUCCINATE (PREDNISOLONE HYDROGEN SUCCINATE) DISOPYRAMIDE PHOSPHATE,BULK FORM-MANUF IN CARLSTADT, NJ FACILITIES HUMAN CHORIONIC GONADOTROPIN (HCG) CHLOROPROCAINE HCL MFG IN PHILLIPSBURG, NJ FACILITIES FACILITIES FOR THE MFG OF LIQUID & SOFT GELATIN CAPSULE PRODUCTS SODIUM FLUORIDE 22MG, SUSTAINED ACTION CAPSULES MFG IN INWOOD, NY DEXAMETHASONE BASE, USP XX COATINGS IN 8500-A--AND 8510-A SERIES--MFG WAUKEGAN, ILLINOIS FACILS PRAZIQUANTEL 2-(CYCLOHEXYLCARBONYL)-1,2,3,6,7,11B-4HPYRAZINO-(2,1-A) PROPRANOLOL HCL

LEK PHARMACEUTICAL & CHEMICAL WORKS CALCIUM (GLUCOHYTONATE) GLUCEPTATE

LEK PHARMACEUTICAL & CHEMICAL WORKS LITHIUM CARBONATE

SOP FOR STORAGE & DISTRIB. OF CLINICAL DRUGS-MCLEAN,VA.-(NCI CONTRACT)

ABBOTT LABORATORIES PHARMACEUTICAL SPEC, STANDARD CONTROL PROCEDS & TEXT METHODS FOR INACTIVE INGREDS. PRODUCTS DIV AINC MANUF OF MICROSPOROUS MEMBRANE FLA STOCK PRODUCTS FOR PHARM USE ACIC LTD PROCEDURES FOR THE MANUF OF PROCHLORPERAZINE EDISYLATE

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4Q2012EXCEL DMF# 4303 I 4304 4305 4306 4307 4308 4309 4310 4311 4312 4313 A 4314 4315 4316 4317 I 4318 4319 4320 4321 4322 4323 4324 4325 4326 4327 4328 4329 4330 4331 4332 I 4333 4334 4335 4336 4337 I 4338 4339 I I II II 10/16/1981 10/19/1981 I A I I II II II II II 11/25/1981 10/28/1981 10/19/1981 10/30/1981 10/21/1981 I I I I I A I I I I A I I I I II II II II II II II I I II II II II III 11/5/1981 10/19/1981 11/10/1981 10/19/1981 10/8/1981 11/10/1981 10/1/1981 10/19/1981 9/2/1981 11/10/1981 10/2/1981 10/19/1981 10/23/1981 10/19/1981 9/23/1981 I I I II II V II 11/9/1981 10/19/1981 11/6/1981 10/15/1981 AZIENDE CHIMICHE RIUNITE ACIC LTD TOXICOL-SISA INC SCHERING PHARMACEUTICAL CORPORATION ISP ACIC LTD SHERWIN-WILLIAMS CO ACIC LTD SUNEETA LABORATORIES LTD ALBEMARLE CORP SIGMA F AND D DIV LTD ACIC LTD FLESSEN PLASTIC INC PHARMACIA AND UPJOHN INC PROCOS SPA ACIC LTD ORGAMOL SA ACIC LTD TECHNICAL COATINGS CO SUB OF BENJAMIN MOORE & CO DIOSYNTH BV ACRAF ACIC LTD D M PHARMACEUTICALS INC MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC FABBRICA ITALIANI SINTETICI SPA ACIC LTD I A I I I I I I A II II III II II II I II II II 9/24/1981 10/22/1981 10/5/1981 10/19/1981 8/28/1981 10/23/1981 9/30/1981 10/19/1981 10/21/1981 11/3/1981 ACF CHEMIEFARMA NV LOFTUS BRYAN CHEMICALS LTD ALUMINUM COMPANY OF AMERICA ACIC LTD SCHERING AG SIGMA F AND D DIV LTD AMERICAN PLASTICS CO INC ACIC LTD SCHERING PLOUGH AVONDALE CO COPPERHEAD INVESTMENTS INC SULFAMETHOXAZOLE USP XX CHLORPHENIRAMINE MALEATE SPECIFS FOR ALCOA CLOSURE STRUCTURES IN THE 6000 SERIES PROCEDURES FOR THE MANUF OF ALLOPURINOL MEGLUMINE (D(-) N- METHYLGLUIAMINE) N-(2-MERCAPTOPROPIONYL) GLYCINE STATUS Type SUBMIT DATE II 9/29/1981 HOLDER SUBJECT LEK PHARMACEUTICAL & CHEMICAL WORKS 3-HYDROXYMETHYLNITROFURANTOIN

4Q2012

PERSONNEL FACILS & GEN OPER PROCEDS - INDEPENDENCE MISSOURI LOCATION PROCEDURES FOR MFG OF AMITRIPTYLINE HCL DEXBROMPHENIRAMINE MALEATE SDM 27 (10% NITROGLYCERIN IN PROPYLENE GLYCOL) MANUFACTURED IN TAMAQUA, PA. LONIDAMINE PROCEDURES FOR THE MFG OF CHLOROTHIAZIDE PRROGENICITY TESTING OF THALLOUS CHLORIDE T1-201 INJECT BETAMETHASONE USP FACILITY FOR BULK PHARMS. (FORMERLY ALBANY INTER. CORP) PROCEDURES FOR THE MFG OF DIPYRIDAMOLE 4-ETHYL-2-NITROPHEND AS MFG IN THE CHICAGO ILLNOIS FACILITIES PROCEDURES FOR MFG OF FUROSEMIDE PROBENECID USPXX LIDOCAINE USP XX AND HCL USP XX MANUFACTURED IN SOUTH HAVEN, MICHIGAN. 5-BROMO-2'-DEOXYURIDINE CHLOROTHIAZIDE PROCEDURES FOR MFG OF PERSONNEL, FACILS & GEN OPER PROCEDS AT THE GREENVILLE, N.C. LOCATION A THE CHRISTIANSTED, ST. CROIX LOCATION PHENELZINE SULFATE PROCEDURES FOR THE MANUF OF IBUPROFEN LIDOCAINE BASE / LIDOCAINE HCL IMIPRAMINE HCL PACKAGING MATERIALS IN THE HS-SERIES AS MANUF IN NUTLEY, NJ FACILS METHDILAZINE HYDROCHLORIDE DAPIPRAZOLE MANUF PROCEDURES FOR PROCHLORPERAZINE MALEATE CAPSULES --ACETAMINOPHEN-325MG; CAFFEINE 40MG; & BUTALBITAL 50MG MK-803 (MEVINOLIN) AS SYNTHESIZED-PILOT PREPARATION OF RAHWAY NJ PLANT FURAZOLIDONE BULK PROCEDURE FOR THE MANUF OF SULFINPYRAZONE

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4Q2012EXCEL DMF# 4340 I 4341 4342 4343 4344 4345 4346 4347 4348 4349 4350 4351 4352 4353 4354 4355 4356 I 4357 4358 4359 4360 4361 4362 I 4363 4364 4365 4366 4367 I 4368 4369 4370 4371 4372 4373 4374 4375 4376 4377 I A I I I I I I A A II II III III II II II II II III 12/8/1981 12/8/1981 10/28/1981 11/20/1980 11/25/1981 11/10/1981 12/21/1981 10/8/1981 11/12/1981 10/30/1981 I I I I II I II II II 11/9/1981 11/20/1981 9/22/1981 11/25/1981 12/14/1981 I A I I I III II II II II II 11/20/1981 10/20/1981 11/25/1981 10/15/1981 12/8/1981 11/13/1981 ALZA CORP BASF PHARMACHEMIKALIEN GMBH CO KG GRINDSTED PRODUCTS LABOCHIM SIGMA F AND D DIV LTD RUETGERS-NEASE CHEMICAL COMPANY INC PLANTEX LTD CHEM AND PHARM WORKS VITAGEN COATING INC SCHERING AG GRINDSTED PRODUCTS MALLINCKRODT PHARMS DIV MALLINCKRODT INC SIGMA F AND D DIV LTD CAMBREX PROFARMACO MILANO SRL HOECHST CELANESE CORP ARMSTRONG PRODUCTS CO BASF HEALTH AND NUTRITION AS PIERREL SPA MALLINCKRODT INC MONSANTO COMPANY CAMBREX PROFARMACO MILANO SRL EXXONMOBIL CHEMICAL CO A I I I I I I I I I I I I I I II II III II II II II II II III II II II II II I 11/18/1981 10/19/1981 8/5/1981 10/30/1981 10/27/1981 10/19/1981 12/3/1981 12/8/1981 12/2/1981 12/4/1981 12/11/1981 11/19/1981 11/30/1981 11/25/1981 11/6/1981 10/15/1981 STATUS Type SUBMIT DATE III 9/23/1981 HOLDER TECHNICAL COATINGS CO SUB OF BENJAMIN MOORE & CO BASF PHARMA EVIONNAZ SA ACIC LTD BARNHARDT MANUFACTURING CO SHOWA DENKO KK SALK INSTITUTE ACIC LTD ZENECA PHARMACEUTICALS GANES CHEMICALS INC GLAXOSMITHKLINE NASHUA CORP CIPLA LTD MALLINCKRODT INC SIGMA F AND D DIV LTD GRINDSTED PRODUCTS HOECHST AG LABOCHIM SUBJECT

4Q2012

PACKAGING MATERIALS IN THE FT-SERIES-PAPER HEAT SEAL PRODS.-NUTLEY,NJ CARBAMAZEPINE PROCEDURES FOR THE MANUF OF TRIFLUOPERAZINE HCL COTTON & RAYON PHARMACEUTICAL COILS AS PRODUCED IN THE MA FACILS. SPECIFIC DRUG SUBSTANCE-EG-626 COMPOUND [IMBZL)-D-HIS 6, PRO 9-NET}-GNRH PROCEDURES FOR THE MANUF OF THIORIDAZINE HCL LEUKOTRIENES-MANUF IN WILMINGTON DEL. FACILITIES BETHANECHOL CHLORIDE AS MANUF IN THE CARLSTADT, NJ FACILITIES CLAVULANATE POTASSIUM, BULK FORMS-MANUF AT BEECHAM IN SUSSEX, ENGLAND MANUF OF BP-1 A THE MERRIMACK NEW HAMPSHIRE LOCATION TRIOXSALEN, PROCEDS.FOR THE MFG OF SOD. IODIDE I-123 RADIOCHEM. SOL.-BURLINGAME,CA-(DFORMERLY RADPHARM MELATONIN SODIUM ASCORBATE ACETAMINOPHEN, BULK FORM MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. ALZAMER BIOERODIBLE POLYMERIC MATERIALS--PRODUCED IN THE PALO ALTO CA. (-)-EPHEDRINE SALTS THIAMINE HCL (VITAMINE B1) TOLBUTAMIDE DIAMINE OXIDASE SUPROFEN AS MANUF IN THE STATE COLLEGE PENN. FACILITIES TRIAMTERENE U.S.P. PERSONNEL, FACILS & GEN OPER PROCEDS A THE UPPER SADDLE RIVER, NJ LOC IPODATE SODIUM BUTABARBITAL SODIUM STRONTIUM NITRATE PURIFIED MNFG ST.LOUIS, MISSOURI FACILITIES CATALASE METHYCLOTHIAZIDE HOSTALEN (R) GF-7750 M-POLYETHYLENE RESIN OLEFIN POLYMERS-PASADENA, TX SIDE STRIPE POWDERS IN 77-AP SERIES MNFG WARSAW,IN FACILITIES ASCORBIC ACID L-AMINO ACIDS INDIUM CHL IN 111 RADIOCHEM. SOL. AS PRODUCED IN BURLINGAME CA. FACILS DEQUEST 2041-D (METHYLENE PHOSPHORIC ACID (EDTEMP)ETHYLENEDIAMIN TETRA TEMAZEPAM LOW DENSITY POLYETHYLENE RESINS MANUFACTURED IN BEAUMONT, TEXAS.

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4Q2012EXCEL DMF# 4378 4379 4380 4381 I 4382 4383 I 4384 4385 I 4386 4387 4388 4389 4390 I 4391 4392 4393 4394 4395 4396 4397 4398 4399 4400 4401 4402 4403 4404 4405 I 4406 4407 4408 4409 I 4410 4411 I 4412 4413 I I II II 12/18/1981 1/11/1982 KV PHARMACEUTICAL CO TROPONWERKE GMBH CO KG I II I 1/7/1982 1/22/1982 HOECHST AG POLYSCIENCES INC I I I II II II I 1/15/1982 11/25/1981 1/15/1982 1/18/1982 SCHERING AG BASF HEALTH AND NUTRITION AS LINSON LTD ORGANON OSS I A I I A I A I I I I I I I II III II II II II II II II II II II II II I 1/5/1982 1/14/1982 1/14/1982 1/18/1982 11/25/1981 12/24/1981 12/22/1981 12/15/1981 12/18/1981 12/24/1981 11/25/1981 12/23/1981 12/22/1981 1/12/1982 12/21/1981 I I I I II II II II II 6/25/1982 11/23/1981 11/25/1981 12/17/1981 1/14/1982 I II II 12/17/1981 11/6/1981 SALK INSTITUTE SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT FABBRICA ITALIANI SINTETICI SPA LONZA INC GRINDSTED PRODUCTS DIOSYNTH BV I II I 12/7/1981 11/17/1981 ALTANA LOMBERG CHEMISCHE FABRIK CYANAMID GREAT BRITAIN LTD STATUS Type SUBMIT DATE I I I II II II II 11/25/1981 12/16/1981 10/26/1981 9/14/1981 HOLDER GRINDSTED PRODUCTS KOR INC PROCOS SPA DINAMITE DIPHARMA SPA SUBJECT GRINDTAB MEPRO 246

4Q2012

13C-AMINOPYRINE PROCESSED CAMBRIDGE, MA., SECOND SUBMISSION 12-16-81 VALPROIC ACID METOCLOPRAMIDE HYDROCHLORIDE MANUFACTURED IN THE BARANZAE DI BOLLATE (MILAN), ITALY FACILITIES URAPIDIL DRUG SUBSTANCE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GREAT BRITAIN. CORTICOTROPIN RELEASING FACTOR (CRF) ETOPOSIDE (VP 16-213) (ETHYLIDENE) QUAZEPAM--BULK DRUG CHORHEXIDINE DIACETATE BP 73 MFG IN VISP, SWITZERLAND PYRIDOXINE HYDROCHLORIDE VECURONIUMBROMIDESECOND SUBMISSION 12-17-81

ROCHE VITAMINS AND FINE CHEMICALS DIV BETA-CAROTENE CAPS., 30MG AS PRODUCED IN NUTLEY,NJ FACILITIES HOFFMAN LAROCHE INC UNION CARBIDE CORPORATION LECITHIN (BOLEC PC 80+) OLIVER TOLAS HEALTHCARE PACKAGING LINSON LTD CHEMI SPA DUPONT NUTRITION BIOSCIENCES APS VIS FARMACEUTICA HOVIONE FARMACIENCIA SA KV PHARMACEUTICAL CO WYCKOFF CHEMICAL CO INC NAPP CHEMICALS INC GRINDSTED PRODUCTS LONZA RIVERSIDE DM GRAHAM LABORATORIES INC KV PHARMACEUTICAL CO MALLINCKRODT INC HEAT SEAL LABEL MATERIAL AS PRODUCED IN PENNSYLVANIA FLUPHENAZINE HYDROCHLORIDE, BULK FORM INDOMETHACINE USP XX BUTALBITAL (ESUB) METHYLCLOTHIAZIDE BETAMETHASONE 17-VALERATE KETOPROFEN S.R. CAPS., 150MG & 200MG-MFGR IN ST. LOUIS, MO. FOR IVES DIPHENHYDRAMINE HCL USP XX-MANUF IN THE KALAMAZOO, MICHIGAN FACILS SULFACETAMIDE SULFAMERAZINE HYDROXYAMPHETAMINE HYDROBROMIDE ISORBIDE DINITRATE C.R. CAPS 80MG NICOTINIC ACID CAPSULES 125,250, & 500MG MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN PETTEN, HOLLAND FACILITY. NANDROLONE PHENPROPIONATE,17 B-(3-PHENYLPROPIONYLOXY-)4-ESTREN-3-ONE RIBOFLAVINE FLUMETHIAZIDE AS MANUF BY SWORDS LABS., LTD OF IRELAND MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. GONADORELIN BULK DRY SUBSTANCE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURE IN WARRINGTON, PA. HEXASTA CAPS, 50 & 100MG-MFGR IN ST. LOUIS, MO. FOR IVES LABS INC CROTAMITON

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4Q2012EXCEL DMF# 4414 4415 4416 A 4417 4418 4419 4420 4421 I 4422 4423 4424 I 4425 I 4426 I 4427 4428 I 4429 I 4430 4431 I 4432 4433 4434 I 4435 4436 I 4437 4438 4439 4440 4441 4442 4443 4444 4445 4446 I I A I I A I I I I II II II II II II II II III I 1/25/1982 2/18/1982 4/14/1981 2/18/1982 12/21/1981 2/18/1982 2/5/1982 6/22/1982 2/2/1982 2/10/1982 A II II 1/29/1982 2/4/1982 I I III II II 1/27/1982 12/21/1981 2/17/1982 I II II 2/3/1982 1/21/1982 I 1/25/1982 I III III 10/19/1981 12/22/1981 VALSPAR CORP FGC ACQUISITION COMPANY LLC I 12/21/1981 II 1/20/1982 SOCIETA ITALIANA MEDICINALI SCANDICCI (SIMS) NORAMCO INC I A II II I 2/1/1982 2/3/1982 1/29/1982 I I I A II II II II II 1/27/1982 1/11/1982 12/21/1981 2/3/1982 2/1/1982 STATUS Type SUBMIT DATE I I II II II 12/21/1981 1/20/1982 1/23/1982 HOLDER GRINDSTED PRODUCTS HOECHST CELANESE CORP LABORATORIO CHIMICO INTERNAZIONALE SPA NATL INST HLTH NCI E MERCK GRINDSTED PRODUCTS TEVA PHARMACEUTICAL INDUSTRIES LTD SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP SWORDS LABORATORIES LTD SANOFI CHIMIE PHARMACEUTICAL RESEARCH INSTITUTE SUBJECT SULFAMERAZINE SODIUM

4Q2012

DOPAMINE HCL, BULK DRUG SUBSTANCE-MFGR IN THE COVENTRY, R.I. FACILITY CARISOPRODOL SANGIVAMYCIN HCL (NSC 143648) AS PREPARED BY THE FREDERICK CANCER RES. PRODUCT 502006, VITAMIN K PHYTONADIONE SULFAMETHAZINE SODIUM DESONIDE DIPHENIDOL HCL AS MFGR IN THE PENNA. FACILS TRIFLUPROMAZINE & TRIFLUPROMAZINE HCL AS MANUF IN SWORDS LABS. FLUOROMETHOLONE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WORTHINGTON, OHIO. DISOPYRAMIDE PHOSPHATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN AHENS, GEORGIA. LAMINAING ADHESIVES AS PRODUCED IN THE ILLINOIS FACILITIES

CLOSURES FOR USE IN PACKAGING OF PHARMACEUTICAL PRODUCTS MANUFACTURED IN BROOKLYN, NEW YORK YAMANOUCHI PHARMACEUTICAL COMPANY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING LTD PROCEDURES. LONZA INC FLAVOXATE HYDROCHLORIDE MFG. PENNSYLVANIA FACILITY RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA HELVOET PHARMA NV NORAMCO INC BROMODIPHENHYDRAMINE HCL BULK RUBBER COMPOUNDS ZOMEPIRAC SODIUM DIHYRATE AS MFG., AHENS, GA. FACILITY

ABBOTT LABORATORIES PHARMACEUTICAL SODIUM THIAMYLAL AS MANUFACTURED IN NORTH CHICAGO ILLINOIS FACILITY PRODUCTS DIV COSMA SPA HYDROXYZINE HCl (ESUB) SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP MONSANTO COMPANY CAMBREX PROFARMACO MILANO SRL BENE PHARMACHEM GMBH AND CO KG BLASCHIM SPA NORAMCO INC ACIC LTD DAIICHI SEIYAKU CO LTD SANOFI INC HELVOET PHARMA ITALIA SPA FARMA FOOD HYDROCHLOROTHIAZIDE IN PHIL PA EMA AS MANUFACTURED A THE LULING, LOUISIANA FACILITIES OXAZEPAM PENTOSAN POLYSULFATE SP54 IBUPROFEN TOLMETIN SODIUM DIHYDRATE AS MANUF IN ATHENS, GA. CHLORPROMAZINE HCL--ACIC PROCEDURES FOR THE MANUF. CETRAXATE HYDROCHLORIDE MFG. IN OSAKA, JAPAN FACILITY AMIODARONE HCL BLACK CHLOROBUTYL RUBBER STOPPERS S 450/60 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BIRKEROED, DENMARK. Page

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4Q2012EXCEL DMF# 4447 I 4448 4449 I 4450 4451 I 4452 4453 4454 4455 4456 I 4457 4458 I 4459 4460 4461 4462 4463 4464 4465 I 4466 4467 I 4468 4469 I 4470 4471 4472 4473 I 4474 4475 4476 4477 4478 4479 I A I A I I II II II IV II II 3/18/1982 3/12/1982 1/25/1982 2/25/1982 3/10/1982 3/24/1982 SIGMA F AND D DIV LTD DELMAR CHEMICALS INC TAKEDA CHEMICAL INDUSTRIES LTD WP DEVELOPMENT AB LABORATOIRES SERONO SA SIGMA F AND D DIV LTD I I I I II II I 3/10/1982 3/8/1982 3/17/1982 3/10/1982 QUINTILES SCOTLAND LTD H FINZELBERG'S NACHFOLGER LONZA INC LABORATOIRES SERONO SA I II I 1/25/1982 2/25/1982 TAKEDA CHEMICAL INDUSTRIES LTD FERROSAN AB I II I 3/17/1982 5/19/1985 LONZA INC LABORATOIRES SERONO SA I I I I I A II II II II II IV I 3/3/1982 3/11/1982 2/25/1982 3/8/1982 2/24/1982 3/5/1982 3/18/1982 SIGMA F AND D DIV LTD CYCLO PRODUCTS INC LABORATOIRES SERONO SA H FINZELBERG'S NACHFOLGER BASF AKTIENGESELLSCHAFT GATTEFOSSE SAS CENTRAL PHARMACEUTICALS INC DL-6-METHYL-5,6,7,8-TETRAHYDROPTERINE THIORIDAZINE HCL AS MANUF IN THE L.A., CALIF FACILITY PROFASI (HCG) HUMAN CHORIONIC GONADOTROPIN) CASANTHRANOL --FACILITIES (MANUFACTURING) 7,-8-DIDEHYDRO-RETINOIC ACID LABRAFIL M 1944 CS MANUFACTURED IN CEDEX,FRANCE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SEYMOUR, IND. CARSONON L-4--MANUF IN LONG BEACH, CA FACILS I II 2/24/1982 I I I I IV II III II II 3/4/1982 2/12/1982 6/29/1981 3/4/1982 2/22/1982 NAARDEN INTERNATIONAL USA INC ISF REXENE CORP SIGMA F AND D DIV LTD SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP ORGAMOL SA I II I 3/3/1982 2/25/1982 LILLY RES LABS DIV ELI LILLY CO SIGMA F AND D DIV LTD I II I 2/5/1982 2/11/1982 DAIICHI SEIYAKU CO LTD PHARMICHEM TESTING SERVICES INC STATUS Type SUBMIT DATE I 2/5/1982 HOLDER AJINOMOTO USA INC SUBJECT

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF CRYSTALLINE AMINO ACIDS IN RALEIGH, NORTH CAROLINA. CETRAXATE HCL CAPSULES MFG IN THE SHIZUOKA, JAPAN FACILITY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TINLEY PARK, ILLINOIS. PROTAMINE S04?MANUF IN FACILS ON SO. DELAWARE ST., INDIANAPOLIS, IND. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. FRAGRANCES: 1. FRAGRANCE N-7043 ISF 2469 (CADRALAZINE) POLYPROPYLENE RESINS IN THE PP 23M SERIES TYRAMINE HYDROCHLORIDE ISOPROPAMIDE IODIDE AS MFGR IN PENN. FACILS.

LEK PHARMACEUTICAL & CHEMICAL WORKS PROPRANOLOL HCL

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN AUBONNE, SWITZERLAND (FORMERLY 4473 AND 4547). PHARMACEUTICAL PROCESSING OF CEFMENOXINE HCL FOR INJECT -HIKARI PLANT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES FOR THE SYNTEX RES. CTR. IN RICCARTON, EDINBURGH, SCOTLAND CASANTHRANOL CARSONON L-23 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES GLUCOSIDASE ESMOLOL (FORMERLY ASL - 8052) TAP-144 LEUPROLIDE BULK PRODUCTION IN CENTRAL RESEARCH DIVISION MULTIPOR COATING POLYMER AS MANUFACTURED IN MALMO, SWEDEN ASELLACRIN (SOMAROPIN) ANGIOTENSIN I

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4Q2012EXCEL DMF# 4480 I 4481 I 4482 4483 4484 4485 I 4486 4487 4488 4489 4490 I 4491 I 4492 4493 A 4494 I 4495 4496 I 4497 I 4498 4499 4500 I 4501 4502 A 4503 4504 4505 4506 4507 4508 I 4509 4510 4511 I I I I II I 4/4/1982 4/19/1982 4/20/1982 I I A I I III II II II II II 2/18/1982 3/18/1982 4/26/1982 3/18/1982 4/14/1982 4/6/1982 I III III 3/10/1982 2/17/1982 I I III II I 3/12/1982 4/15/1982 3/25/1982 II 3/15/1982 COMPANIA ESPANOLA DE SINTESIS QUIMICA SA IMPERIAL CHEMICAL INDUSTRIES PLC DM GRAHAM LABORATORIES INC MCNEIL PHARMACEUTICAL DIV MCNEILAB INC BP CHEMICALS LTD EI DUPONT DE NEMOURS AND CO DIAGNOSTIC IMAGING DIV JOHNSON LAMINATING AND COATING INC SOCIETE SUISSE DES EXPLOSIFS ALBEMARLE CORP TAKEDA PHARMACEUTICAL COMPANY LTD ELANCO SA I II I 2/25/1982 4/6/1982 II 3/10/1982 I II II 4/6/1982 4/5/1982 SIGMA F AND D DIV LTD SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP LABORATORIE GUERBET MY K LABORATORIES INC I 3/29/1982 WYCKOFF CHEMICAL CO INC A I I I II III II II I 4/5/1982 4/2/1982 4/5/1982 2/2/1982 4/2/1982 TEVA PHARMACEUTICAL INDUSTRIES LTD TRAVENOL LABORATORIES INC LABORATORIOS JULIAN DE MEXICO SA DIOSYNTH BV LYPHOMED INC I I I II II III I 1/15/1982 3/11/1982 2/3/1982 3/19/1982 III 3/18/1982 STATUS Type SUBMIT DATE I 3/19/1982 HOLDER MEIJI SEIKA KAISHA LTD SUBJECT

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GIFU PLANT, JAPAN. WAITAKI INTERNATIONAL BIOSCIENCES SUB POLYVINYL ACETATE PHTHALATE(PVAP)AS MFG.IN TORONTO,ONTARIO FACILITIES WAITAKI CANADA LTD SCHERING AG NANDROLONE PHENPROPIONATE INDUSTRIA FARMACEUTICA SERONO SOLVAY & CIE SA MEIJI SEIKA KAISHA LTD PURE URINARY FSH ALSO REFERRED TO AS UROFOLLITROPHIN AND PERGONAL FSH HD-PE HOMOPOLYMER ELTEX A 1050 P MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN OSAKA CITY, JAPAN. FLUOCINOLONE ACETONIDE PROD. OF FROZEN PARENTERAL INJECTS IN PLASTIC CONTAINERS HYDROCHLOROTHIAZIDE HYALURONIDASE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ORLANDO, FLORIDA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SOUTH HAVEN, MICHIGAN. BIOACTIVE PEPTIDES (FORMERLY SOMATOSTATIN) CLONIDINE HCL DOXEPIN HCL AS MANUF IN THE PENN. FACILS. IOXAGLIC ACID MANUFACTURED A AULNAY, FRANCE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SKOKIE, ILL. DEXAMETHASONE SODIUM PHOSPHATE USP XX MELINEX 800 AND ALKAHENE MASTERBACH 0121 WHITE 1036 ACTIFED S.A. BRAND OF PSEUDOEPHEDRINE HCL 120MG & TRIPTOLIDINE 5MG MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SPRING HOUSE, PENNSYLVANIA. RIGIDEX TYPE HPDE POLYMERS ALATHON 3120 RESIN--ELVAX (R) RESINS MANUFACTURED IN DELAWARE. LAMINATED PACKAGING MATERIALS MANUFACTURED IN CARSON CITY. NITROGLYCERIN,PENTAERYTHRITOL TETRANITRATE AND ISOSORBIDE DINITRATE PARA-AMINOHIPPURIC ACID USP XX - MANUF IN SOUTH HAVEN, MICHIGAN PYRIDOXINE HYDROCHLORIDE BENOXAPROFEN TECHNICAL

ABBOTT LABORATORIES PHARMACEUTICAL HYDROCHLOROTHIAZIDE-MANUF IN NORTH CHICAGO, ILLINOIS FACILITIES PRODUCTS DIV KALI-CHEMIE PHARMACEUTICA GMBH (PILOT PLANT) DIOSYNTH BV HYGENIC CORP METHDILAZINE FOR NATURAL LATEX SHEETING-MFGR IN AKRON, OHIO FACILS.

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4Q2012EXCEL DMF# 4512 4513 I 4514 4515 4516 4517 4518 4519 A 4520 I 4521 4522 4523 4524 4525 4526 4527 4528 I 4529 4530 I 4531 A 4532 A 4533 4534 4535 A 4536 I 4537 4538 A 4539 4540 4541 A 4542 I 4543 I III 5/20/1982 RJR PACKAGING I 5/14/1982 A I II II III 5/17/1982 5/18/1982 4/20/1982 I II II 4/7/1982 4/7/1982 V 5/14/1982 AMERICAN PHARMACEUTICAL PARTNERS, INC. DIPHARMA FRANCIS SPA RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA SPA R MASON CHEMICALS LTD SIGMA F AND D DIV LTD AMERICAN PACKAGING CORP EXTRUSION LAMINATING AND COATING DIV UG CLOSURES & PLASTICS LTD I I I II II 4/9/1982 5/7/1982 5/7/1982 MAR-KAY PLASTICS INC SCHERING AG ABBVIE INC PERSONNEL, FACILITIES AND GENERAL OPERATING PROCEDURES 6-METHYLPREDNISOLONE-21-HEMISUCCINATE II 5/10/1982 II 4/7/1982 RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA SPA PFIZER INC I II I 5/5/1982 4/16/1982 I I A A A I I II I II II II II II III 4/7/1982 3/12/1982 5/3/1982 5/10/1982 4/20/1982 4/20/1982 4/26/1982 5/11/1982 SIGMA F AND D DIV LTD SPECTOR MOLDING INC COSMA SPA PHARMACIA AND UPJOHN SUB PFIZER INC AMRI RENSSELAER INC DIOSYNTH BV DUPHAR BV ABBOTT LABORATORIES HOSP PRODUCTS DIV SIGMA F AND D DIV LTD SP INDUSTRIES I 4/26/1982 DUPHAR BV A I I A I II II II II IV II 4/16/1982 5/7/1982 5/4/1982 5/4/1982 5/17/1982 4/30/1982 STATUS Type SUBMIT DATE I II II 4/23/1982 3/29/1982 HOLDER ROUSSEL-UCLAF SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT COSMA SPA MALLINCKRODT INC SCHERING AG CAMBREX PROFARMACO MILANO SRL KABI PHARMACIA HEPAR INC ABBVIE INC SUBJECT TESTOSTERONE (DIOSYNTH BV) DIBENZOSUBERONE HYDROXYZINE PAMOATE (ESUB) AS MANUFACTURED IN BERGAMO ITALY

4Q2012

COMPAP (TM)--MFGR BY DR. MADIS LABORATORIES, INC --SO. HACKENSACK,NJ 6A-METHYLPREDNISOLONE-21-ACETATE LORAZEPAM EGG YOLK PHOSPHATIDE--MFGR IN THE FRANKLIN, OHIO FACILS PRAMOXINE HCL (ESUB) AS MANUFACTURED IN THE NORTH CHICAGO, ILLINOIS FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN OLST, THE NETHERLANDS. ALPHA-LINOLENIC ACID FACILITIES AND GENERAL OPERATING PROCEDS METOCLOPRAMIDE HCL (ESUB) AS MANUFACTURED IN ITALY DEXAMETHASONE USP MICRONIZED AS MANUF IN KALAMAZOO MI FACILITY MEPERIDINE HCL USP-MANUF IN RENSSELAER,NY FACILITIES METHANDRIOL DIPROPIONATE YUTOPAR (RITODRINE HCL) TABLETS & INJECTION FORMS,OLST,HOLLAND SPECS FOR CONTAINER & CLOSURE USED IN MANUF OF SVP & LVP PRODUCTS D-BIOTIN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN EDISON, NEW JERSEY. DIPHENYLHYDANTOIN DEXAMETHASONE ACETATE USP ANHYDROUS MICRONIZED-MANUF IN KALAMAZOO MI

CLORAZEPATE DIPOTASSIUM (TRANXENE) (ESUB) AS MANUFACTURED IN N. CHICAGO, ILL FACIL STERILE PROCESSING FACILITY IN MELROSE PARK, IL HYDROFLUMETHIAZIDE USP DIPHENYLHYDANTOIN SODIUM SALT SELENIUM DISULFIDE DIETHYLENETRIAMINEPENTAACETIC ACID (CLINICAL STUDY BY D.HONEYCHURCH) PACKAGING MATERIALS AS MFG IN ROCHESTER, NEW YORK. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF BOTTLES AND CLOSURES. PUSH-THROUGH BLISTER BACKING MATERIALS PRODUCED WINSTON-SALEM, N.C.

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4Q2012EXCEL DMF# 4544 4545 4546 4547 I 4548 4549 I 4550 I 4551 4552 I 4553 4554 4555 4556 4557 4558 I 4559 I 4560 A 4561 4562 4563 4564 4565 4566 I 4567 I 4568 4569 4570 4571 4572 A 4573 4574 4575 4576 I I I I II II II II 5/4/1982 6/2/1982 4/29/1982 4/21/1982 PHARMA-WALDHOF GMBH ICI AMERICAS INC CIECH POLFA CILAG CHEMIE AG ADENOSINE-5-MONOPHOSPHORIC ACID, PRODUCT #2030 I I A A II IV II IV III 4/23/1982 4/28/1982 5/21/1982 6/10/1982 6/9/1982 III 2/10/1982 A N I I N III 6/9/1982 II II 6/18/1982 5/14/1982 II 5/12/1982 FINE CHEMICALS CORP PTY LTD NOT AN ASSIGNED NUMBER ALTANA INC MEIJI SEIKA KAISHA LTD NOT AN ASSIGNED NUMBER URAPIDIL AMPULES AS PRODUCED IN THE HICKSVILLE, NY FACILITY NEOTHRAMYCIN VINCRISTINE SULPHATE/VINBLASTINE SULPHATE III 4/5/1982 I 4/29/1982 I A A I I II III II IV II I 6/2/1982 6/7/1982 3/17/1982 5/10/1982 5/25/1982 5/25/1982 I II II 6/7/1982 6/7/1982 I 4/23/1982 I I I 3/18/1982 5/11/1982 LEO PHARMACEUTICAL PRODUCTS LTD KEY PHARMACEUTICALS INC SUB SCHERING PLOUGH CORP ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV MEDIMPEX NORTHAMERICA INC SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT DURHAM PHARMACEUTICALS LLC PHOENIX CLOSURES INC AJINOMOTO AMINOSCIENCE LLC GATTEFOSSE ESTABLISSEMENTS HERCULES INC PLOUGH INC STATUS Type SUBMIT DATE A I I III II II I 5/21/1982 5/13/1982 5/18/1982 5/24/1982 HOLDER SELIG SEALING PRODUCTS INC SCHERING AG SIGMA F AND D DIV LTD LABORATOIRES SERONO SA SUBJECT CAP LINERS MANUFACTURED IN FORREST, ILLINOIS. PIRAZOLAC PYRUVIC ACID SODIUM SALT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES . FACILS & CONTROLS USED IN MFGR OF SODIUM FUSIDATE CAPS. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MIAMI, FLORIDA ON 176 ST. QUALITY ASSURANCE OPERATIONS STANDARDS

4Q2012

OXYTOCIN-MANUF BY CHEMICAL WORKS OF GEDEON RICHTER LTD-BUDAPEST ACEPAM AZONE CLOSURES & LINING MANUFACTURED IN NAPERVILLE, ILLINOIS. AMINO ACIDS MANUFACTURED IN RALEIGH, NORTH CAROLINA. PRECIROL ATO 5. PENTAERYTHRITOL TETRANITRATE DILUTED (PETN)

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. AH ROBINS CO MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES . ST GOBAIN PERFORMANCE PLASTICS CORP TFE/POLYETHYLENE LAMINATES AS PRODUCED IN THE WAYNE NEW JERSEY PLANT

SAINT-GOBAIN PERFORMANCE PLASTICS TFE/14B RUBBER LAMINATES AS PRODUCED IN HOOSICK FALLS AND POESTENKILL NY CORPORATION ROLLING DIV NATIONAL ALUMINUM UNIT OF ALUM FOIL/PAPER LAMINATIONS AS PROD IN SOMERVILLE, MASS FACILITY NATIONAL STEEL CORP PHARMA-WALDHOF GMBH URIDINE PRODUCT #3401 NEWMANN BUSLEE & WOLFE INC FERMION OY HENKEL CORP NATURAL & ARTIFICIAL FLAVOR #390170 & 365070 TRAZODONE HYDROCHLORIDE MANUFACTURED IN OULU, FINLAND. PRESSURE SENSITIVE ADHESIVES MANUFACTURED IN PLAINFIELD, NEW JERSEY.

ST GOBAIN PERFORMANCE PLASTICS CORP TFE SILICONE LAMINATES AS PROD IN THE WAYNE, NJ PLANT

G-100 DIMETHYL ISOSORBIDE/ANIMAL STUDIES-IN VITRO BLOOD COMPA TESTS SULFAQUINOXALINE SUPROFEN

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4Q2012EXCEL DMF# 4577 4578 4579 4580 4581 4582 4583 I 4584 4585 4586 I 4587 4588 I 4589 I 4590 I 4591 4592 4593 4594 I 4595 4596 4597 4598 4599 I 4600 4601 4602 4603 4604 I 4605 4606 4607 4608 I 4609 I I 7/13/1982 I I I II I II II 6/15/1982 6/29/1982 7/23/1982 7/14/1982 I I I I II II I II II 6/21/1982 6/23/1982 7/15/1982 7/2/1982 7/18/1982 I I I I II II II I II 6/14/1982 6/17/1982 6/16/1982 6/11/1982 6/16/1982 A I I II I I II 7/9/1982 7/9/1982 7/7/1982 5/17/1982 I 7/8/1982 MICRO BIO TESTING & RESEARCH LABORATORIES TEVA PHARMACEUTICAL INDUSTRIES LTD GLAXO WELLCOME INC LEO PHARMACEUTICAL PRODUCTS LTD INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA DIOSYNTH BV GANES CHEMICALS INC SCHERING AG APPLIED ANALYTICAL INDUSTRIES CIBA GEIGY CORP PHARMACEUTICAL DIVISION MD PHARMACEUTICAL INC BIDACHEM SPA BANNER GELATIN PRODUCTS CORP FREEDOM CHEMICAL DIAMALT GMBH COMPANIA ESPANOLA DE SINTESIS QUIMICA SA OCE ANDENO BV HARRIS LABORATORIES INC PFIZER INC ORION CORPORATION FERMION OULU PLANT SCHERING PHARMACEUTICAL CORPORATION I 7/7/1982 CONNAUGHT LABORATORIES INC I II I 6/14/1982 4/23/1982 I I II II II 5/14/1982 5/25/1982 5/19/1982 STATUS Type SUBMIT DATE I I I I I I II II II II IV II II 4/30/1982 6/9/1982 5/24/1982 6/3/1982 6/4/1982 6/11/1982 6/15/1982 HOLDER MEIJI SEIKA KAISHA LTD GLAXOCHEM LIMITED LABORATOIRES SERONO SA MD PHARMACEUTICAL INC AH ROBINS CO AINC CIBA GEIGY CORP PHARMACEUTICAL DIVISION FARMABOIS ACIC LTD STAROGAREZKIE ZAKLADY FARMACEUTYCZNE POLFA SCHERING AG GREEN CROSS CORP SUBJECT NEOTHRAMYCIN, BULK

4Q2012

BETAMETHASONE VALERATE MANUFACTURED IN MONTROSE, ANGUS, SCOTLAND. STILAMIN (SOMATOSTIN)--MFGR IN DEDEENENS, SWITZ.(DFORMERLY HYPOLAB) DIPHENOXYLATE HCL W/1% AROPINE SULFATE SUBSTANCE PLACEBO TABLET MACHING PONDIMIN EXTENTAB MICROPOROUS MEMBRANE CARTRIDGE FOR PHARM USE-MFG IN MERIDEN, CT. FACIL ANAFRANIL INJECTABLE (CLOMIPRAMINE HCL) MFG SUMMIT, NEW JERSEY NANDROLONE-17-DECANOATE USP XX CHENODEOXYCHOLIC ACID TOLBUTAMIDE 6-METHYLPREDNISOLNE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN YODOGAWA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SWIFTWATER, PA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NORTH HOLLYWOOD, CA. FLUOCINONIDE CEPHALOSPORINS FILLING UNIT IN EVREUX, FRANCE PERSONNEL, FACILITIES AND GENERAL OPERATING PROCEDURES IBUPROFEN USP NALOXONE HYDROCHLORIDE SULFINPYRAZONE PREDNISOLONE-21-ACETATE FACILITIES & INSTRUMENTATION RITALIN TRIPROLIDINE HCL MONOHYDRATE-MANUF IN SANTA ANA, CALIF. FACILS. CHLORTHALIDONE U.S.P. FACILS/PERSONNEL/GOP FOR THE OLDS, ALBERTA PLANT CHENODEOXYCHOLIC ACID PREDNISOLONE SODIUM PHOSPHATE, USP XX PROLINE THIOESTER PERSONNEL,FACIL.FLOOR PLANS & EQUIP. LIST FOR LABS & CLINIC-LINCOLN,NE FLUOXYMESTERONE USP THIORIDAZINE HYDROCHLORIDE FACIL, PERSONNEL & GEN OPERATING PROCEDS FOR MANATI, PR PLANT

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4Q2012EXCEL DMF# 4610 I 4611 I 4612 4613 4614 4615 4616 4617 I 4618 I 4619 4620 I 4621 4622 4623 4624 4625 I 4626 4627 A 4628 4629 4630 I 4631 I 4632 4633 A 4634 4635 I 4636 4637 4638 I 4639 I II 7/12/1982 I I I II I 7/29/1982 8/13/1982 8/18/1982 I II II 8/24/1982 8/10/1982 I II II 7/27/1982 7/28/1982 I 7/22/1982 I I II II II 8/11/1982 8/11/1982 7/13/1982 I II II 7/30/1982 7/13/1982 I I I I II II I II II 8/9/1982 8/11/1982 6/10/1982 7/27/1982 7/13/1982 I II III 8/2/1982 8/3/1982 II 8/6/1982 HOECHST ROUSSEL PHARMACEUTICALS DIV DIOSYNTH BV I I I I I II I III II II I 2/16/1982 6/24/1982 6/15/1982 7/22/1982 7/12/1982 7/7/1982 II 6/17/1982 STATUS Type SUBMIT DATE II 6/16/1982 HOLDER SUBJECT PLIVA PHARMACEUTICAL CHEMICAL FOOD & CHLOROTHIAZIDE COSMETIC INDUSTRY PT RIASIMA ABADI INDUSTRI KIMIA FARMASI ACETAMINOPHEN PERTAMA BAYER PARACETAMOL SIBEFAT SPA STALCON PLASTICS LTD KNOLL AG LUDWIGSHAFEN TAKEDA CHEMICAL INDUSTRIES LTD PHARMACIA INFUSION AB FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES PLASTICS BOTTLES DIMENHYDRINATE MANUF OF CEFMENOXIME HCL IN THE HIKARI PLANT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FYRISLUND. PENBUTOLOL SULFATE (BULK FORM) METHANDRIOL

4Q2012

ABBOTT LABORATORIES PHARMACEUTICAL FC81 FLEXIBLE,CONTAINER-PRODUCED IN NORTH CHICAGO, ILL. FACILITIES PRODUCTS DIV SIGMA F AND D DIV LTD METHIONINE ENKEPHALIN-ACETATE SALT CHEMI SPA TARO PHARMACEUTICALS INC FOREST LABORATORIES INC HYDROXYZINE HCL.USP. XX 093082 FACIL & GEN OPER PROCEDS A DOWNSVIEW, ONTARIO, CANADA LOCATION THIORIDAZINE HCL100MG CR(LD IN SYCHRON VEHICLE)MNFG INWOOD,NY

ABBOTT LABORATORIES PHARMACEUTICAL METHYCLOTHIAZIDE MANUFACTURED IN NORTH CHICAGO, ILLINOIS. PRODUCTS DIV YUKI GOSEI KOGYO CO LTD PROTAMINE SULFATE RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA SPA SIGMA F AND D DIV LTD CHEMI SPA DIMENHYDRINATE POLY (ALA,GLU,LYS-HBR,TYR) 6:2:5:1 HYDROXYZINE PAMOATE USP. XX

ABBOTT LABORATORIES PHARMACEUTICAL SPECTINOMYCIN DIHDROCHLORIDE PENTAHYDRATE MFG IN N. CHICAGO, ILL FACIL PRODUCTS DIV PHARMAFAIR INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING IN HAUPPAUGE, NEW YORK. FOREST LABORATORIES INC THIORIDAZINE HCL C.R. TABLETS (IN SYNCHRON VEHICLE) MFG INWOOD, N.Y. SHANDONG XINHUA PHARMACEUTICAL CO LTD SOCIETA ITALIANA CORTICOSTEROIDI SPA NORTH EAST SIXTH PHARMACEUTICAL FACTORY CADEMA MEDICAL PRODUCTS INC HOECHST AG WARNER LAMBERT CO PHARMACEUTICAL RESEARCH DIVISION BECKMAN INSTRUMENTS INC DIV SMITHKLINE BECKMAN CORPORATION THEOPHYLLINE USP XX ANHYDROUS METHYLPREDNISOLONE ACETATE SULFAMETHOXAZOLE USP 20 PERS, FACIL & GEN OP PROC/PRODUC-ANTIMONY TRISULFIDE COLLOID KIT SECRETIN PENTAHYDROCHLORIDE, BULK FORM MFG, PROCESS & PACK OF INDS IN MORRIS PLAINS, NJ FACIL (710 TABOR RD) D-NA 16 LUTENINIZING HORMONE RELEAS. HORMONE-PRODUCED BY BIOPRODUCTS

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4Q2012EXCEL DMF# 4640 I 4641 I 4642 4643 4644 4645 4646 4647 4648 I 4649 4650 4651 4652 4653 4654 4655 4656 4657 I 4658 I 4659 4660 I 4661 4662 4663 4664 4665 4666 4667 4668 4669 4670 4671 4672 4673 4674 4675 I A A I I I I I I A A I I I I II II IV II II II V I I V III II II I I 9/30/1982 9/23/1982 9/16/1982 9/8/1982 9/28/1982 9/27/1982 10/5/1982 10/5/1982 10/8/1982 8/18/1982 8/17/1982 10/16/1982 10/15/1982 9/30/1982 9/22/1982 SHIONOGI AND CO LTD SANOFI CHIMIE GATTESFOSSE SA BAYER HEALTHCARE AG DAIICHI PHARMACEUTICAL CO LTD WYCKOFF CHEMICAL CO INC STERIGENICS INTERNATIONAL TEKNI PLEX INC LIFE LABORATORIES INC ECHO THERAPEUTICS INC PARADIGM PACKAGING MEDIMPEX NORTHAMERICA INC LILLY RES LABS DIV ELI LILLY CO CILAG CHEMIE AG BARD PHARMS LTD I II I 8/24/1982 9/24/1982 II 9/14/1982 I I I A I I I I II II II II II II II II II 7/16/1982 8/24/1982 9/7/1982 8/10/1982 9/13/1982 7/27/1982 9/15/1982 9/15/1982 9/9/1982 A I I I I I II III II II II II III 9/1/1982 9/1/1982 9/2/1982 9/10/1982 9/9/1982 8/5/1982 7/20/1982 IV 8/10/1982 STATUS Type SUBMIT DATE I 8/27/1982 HOLDER HEALTH CHEM CORPORATION HERCON PHARMACEUTICAL DIV CIBA GEIGY CORP PHARMACEUTICAL DIVISION ALKALOIDA CHEMICAL CO ZRT HELVOET PHARMA MARYLAND FOREST LABORATORIES INC BASF AKTIENGESELLSCHAFT STIEFEL LABORATORIES INC CAMBREX PROFARMACO MILANO SRL CARR LOWREY DIV ANCHOR HOCKING CORP AMINO GMBH SICOR SPA NATL INST HLTH NCI SANOFI AVENTIS CHIMIE PROFARMACO SRL SANOFI SYNTHELABO INC. EASTMAN KODAK CO ERIMOS TECHNOLOGIES LLC SUBJECT

4Q2012

PERSONNEL, FACIL & GEN OPERATING PROCEDS FOR EMIGSVILLE, PA PLANT PLACEBO FOR LITHOBID SLOW RELEASE TABLETS; MFG SUMMIT, NEW JERSEY PHENOBARBITAL E0608 MFG AT MORRISTOWN, IND IBUPROFEN 800 MG C.R. TABLETS (IN SYNCHRON VEHICLE) LUROTIN TM CAPSULES COMPOUND C-205 ACETAZOLAMIDE GLASS PRODUCTS (DEFINED BY USP) MFG BALTIMORE, MD PLANT L-TYROSINE METHYLPREDNISOLOME HEMISUCCINATE (FORMERLY HELD BYS.I.R.S.) ELLIOTT'S B SOLUTION NALOXONE HCL AS MANUF BY SEMPA-CHIMIE IN ARAMON, FRANCE MICONAZOLE NITRATE & BASE CHLORMEZANONE METOLAZONE (ZAROXOLYN) AS MFGR IN THE SYNTHETIC CHEM DIV- ROCHESTER NY NORDIHYDROGUAIARECTIC ACID (NDGA), BULK FORM AS MANUF IN CHIHUAHUA,MX.

ABBOTT LABORATORIES PHARMACEUTICAL VALPROIC ACID MFG IN N.CHICAGO, ILL FACILITIES PRODUCTS DIV AYERST LABORATORIES INC DIV AMERICAN RAPAMYCIN (DOSAGE FORM) MFG BY AYERST LABS IN ROUSES PT, NY FACIL HOME PRODUCTS CORP SOCIETA ITALIANA CORTICOSTEROIDI SPA METHYLPREDNISOLONE SOD. SUCCINATE (THIS DFORMERLY HELD BY S.I.R.S) WESTWOOD PHARMACEUTICALS INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BUFFALO, NEW YORK. CERULETIDE DIETHYLAMINE HYDROCORTISONE VALERATE USP BULK SUBSTANCE COMPRITOL 888 (AN EXCIPIENT) NIMODIPINE (ESUB) AS MANUFACTURED IN WUPPERTAL, GERMANY DL-8280, BULK FORM MEPIVACAINE HCL USP XX MFG IN SOUTH HAVEN, MICHIGAN FACIL STERILE AND NON-STERILE MFG FACILITIES IN KALAMAZOO,MI FACIL & GEN OPER PROCEDS FOR RIDGEFIELD, NJ PLANT FACILITIRES AND GENERAL OPERATING PROCEDURES TOXICOLOGY STUDIES FOR AZONE BLOW MOLDED BOTTLES (INJECTION BLOW MOLDING PROCESS) METRONIDAZOLE USP XX AS MANUF-BY CHEM WORK OF GEDEON RICHTER LTD. FLUOXETINE HYDROCHLORIDE, BULK MANUF. IN LAFAYETTE, INDIANA FACIL.,PERS.,GEN OP PROC.;MNFG SOLID,SEMI-SOLID,&LIQUID DOSAGES PERSONNEL,FACILS,& GEN.OPERATING PROCEDS.-A THE OLD FARM RD LOCATION

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4Q2012EXCEL DMF# 4676 4677 4678 4679 I 4680 I 4681 4682 4683 4684 4685 4686 4687 4688 4689 4690 4691 4692 4693 4694 I 4695 4696 4697 4698 4699 I 4700 A 4701 4702 4703 4704 4705 4706 I 4707 4708 4709 4710 4711 I I I A I II I II II II 10/26/1982 11/9/1982 11/12/1982 10/29/1982 11/16/1982 SOCIETA ITALIANA CORTICOSTEROIDI SPA JAMES ROBINSON GMBH DIOSYNTH BV YANGZHOU PHARMACEUTICAL CO LTD MEDIMPEX NORTHAMERICA INC BETAMETHASONE ACETATE I I I I I II I II II II II 11/1/1982 11/3/1982 10/22/1982 10/25/1982 11/1/1982 11/2/1982 DESTILERIAS ADRIAN & KLEIN SA OY STAR AB ER SQUIBB AND SONS INC SCHERING AG KV PHARMACEUTICAL CO DINAMITE DIPHARMA SPA V 11/4/1982 ELI LILLY AND CO I I A I II II II II I 10/14/1982 10/18/1982 10/27/1982 10/11/1982 10/18/1982 A I I A I I A A I A A I I III II II II II II II II II II II II II II 9/17/1982 10/15/1982 10/18/1982 10/13/1982 10/14/1982 10/15/1982 10/14/1982 10/16/1982 9/29/1982 10/13/1982 10/19/1982 10/22/1982 10/13/1982 10/14/1982 II 10/28/1982 SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP BAXTER HEALTHCARE CORP ORION CORP LTD FERMION KV PHARMACEUTICAL CO BAYER PHARMA AG RADPHARM INC ORGANICHEM CORP SUMITOMO CHEMICAL CO LTD KONGO CHEMICAL CO LTD CAMBREX PROFARMACO MILANO SRL BAYER PHARMA AG DISHMAN NETHERLANDS BV HOSPIRA BOULDER INC SANOFI SYNTHELABO INC. INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA SCHERING AG INDUSTRIA CHIMICA PROFARMACO SPA ROQUETTE FRERES HEXACHIMIE SCHERER G.C. CORP STATUS Type SUBMIT DATE A I I II II II I 9/27/1982 9/30/1982 9/28/1982 4/14/1982 HOLDER BASF SE SANOFI CHIMIE DAIICHI PHARMACEUTICAL CO LTD QUAD PHARMACEUTICALS SUBJECT 13-CIS-RETINOIC ACID (ISOTRETINOIN) TRIAMTERENE MFG BY SEMPA-CHIMIE IN ARAMON,FRANCE DL-8280 CAPSULES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN INDIANAPOLIS PLANT ON GUION ROAD TRANYLCYPROMINE SULFATE AS MANUF BY BRIDGE CHEM PRODUCTION OF PARENTERAL INJECTIONS IN GLASS CONTAINERS CHLORTHALIDONE USP XX AND BP 80

4Q2012

PHENYLPROPANOLAMINE HCL/CHLORPHENIRAMINE MALEATE S.R.(B.F. ASCHER &CO) ESTRADIOL MANUFACTURED IN BERLIN, GERMANY. GALLIUM CHLORIDE GA-67 RADIOCHEMICAL SOLUTION DIARIZOATE MEGLUMINE USP DISOPYRAMIDE PHOSPHATE USP XX DEXCHLORPHENIRAMINE MALEATE ECONOZOLE NITRATE ESTRADIOL-3-BENZOATE DIHYDROTACHYSTEROL AS MFG IN WEESP THE NETHERLANDS SODIUM NITROPRUSSIDE HYDROXYCHLOROQUINE SULFATE MFG A FAWDON & DUDLEY TRIMETHOBENZAMIDE HCL USP TESTOSTERONE 2 BROMOACETAMIDO-5 CHLORO-2' FLUOROBENZOPHENONE ROFEROSE (DEXTROSE MONOHYDRATE) 2-CHLORO NICOTINIC ACID (INTERMEDIATE) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF HARDSHELL CAPS IN SPRINGVILLE, UTAH. PROCEDURES FOR STERILE OPERATIONS (ESUB) IN INDIANAPOLIS AND GREENFIELD INDIANA TERPIN HYDRATE USP XX FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES FLUPHENAZINE HYDROCHLORIDE METHYLTESTOSTERONE APTROPINE SULFATE CAPSULES TOLAZAMIDE MANUFACTURED IN THE BARANZAE DI BOLLATE (MILAN), ITALY FACILITIES

FACILITIES, PERSONNEL, GENERAL OPERATING PROCEDURES-DIEBURG, GERMANY NORETHYNODREL HYDROCORTISONE BASE & ACETATE MANUFACTURED IN CHINA. VINCRISTINE S04 FOR INJECT, USP 1MG & 5MG AS MANUF BY GEDEON RICHTER

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4Q2012EXCEL DMF# 4712 4713 4714 4715 I 4716 4717 I 4718 4719 4720 4721 I 4722 I 4723 4724 4725 4726 4727 4728 4729 4730 4731 4732 I 4733 4734 4735 4736 4737 4738 4739 4740 4741 4742 4743 4744 4745 4746 4747 4748 I I I I I I I I A I I I I I I I III II II II II II II II II II II I II II III II 9/10/1982 12/1/1982 11/29/1982 11/19/1982 12/13/1982 11/29/1982 12/7/1982 10/19/1982 11/15/1982 11/29/1982 11/18/1982 11/10/1982 11/30/1982 12/9/1982 12/16/1982 11/29/1982 I I I I I I I A I I II II II II I II II II I 10/25/1982 9/9/1982 11/23/1982 11/17/1982 12/8/1982 12/1/1982 12/2/1982 12/7/1982 11/30/1982 11/17/1982 II 11/12/1982 I C I II II I IV 11/10/1982 11/10/1982 11/15/1982 11/19/1982 SOCIETA ITALIANA CORTICOSTEROIDI SPA TEVA PHARMACEUTICAL INDUSTRIES LTD PHARMACIA AND UPJOHN INC CAPSULE TECHNOLOGY INTERNATIONAL LTD SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT LABORATOIRE CHOAY ASTA-WERKE AKTIENGESELLSCHAFT SALK INSTITUTE SIGMA F AND D DIV LTD SALK INSTITUTE 3M PHARMS SIGMA F AND D DIV LTD YUKI GOSEI KOGYO CO LTD ORGANICHEM CORP VOCATIONAL INDUSTRIES OF SOMERSET AREA BCL CANADA INC LEIRAS PHARMACEUTICALS COSMA SPA SIGMA F AND D DIV LTD ADAMHA NIDA KV PHARMACEUTICAL CO PHARMACIA AND UPJOHN INC NV ORGANON FARCHEMIA SRL COSMA SPA BASF HEALTH AND NUTRITION AS LABORATOR MAG VIA MILANO SCHERING AG DIOSYNTH BV SPARTECH PLASTICS COSMA SPA TRIAMCINOLONE DIACETATE CARBAMAZEPINE USP. PERSONNEL, FACILITIES & GENERAL OPERATING PROCEDURES A II II 11/15/1982 11/10/1982 FARCHEMIA SRL STATUS Type SUBMIT DATE A I I II I II I 10/26/1982 11/8/1982 11/10/1982 10/22/1982 HOLDER TEVA PHARMACEUTICAL INDUSTRIES LTD DURAMED PHARMACEUTICALS INC FOURTH PHARMACEUTICAL WORKS TENCO ASSEMBLIES INC SUBJECT TRIAMCINOLONE ACETONIDE FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES SYNTHESIS OF PHENOBARBITAL, BULK FORM MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. IMIPRAMINE HCL USP

4Q2012

MALLINCKRODT SPECIALTY CHEMICALS CO CODACET-60 (TM) AS MFG IN THE ST. LOUIS, MISSOURI PALNT

MANUFACTURING OF EMPTY HARD GELATIN CAPSULES; WINDSOR, ONTARIO PLANT VEPESID AMPULS, 100MG./5ML. FACILITIES & GEN OP PROC.,MANUFACTURE OF PARENTERAL PRODUCTS CYCLOPHOSPHAMIDE TABLETS HUMAN PANCREAIC GROWTH RELEASE FACTOR (1-40)-OH -- HP GRF (1-40)-OH TRIMETHOPRIM SOMATOCRININ-GROWTH HORMONE RELEASING FACTOR PERSONNEL,FACILITIES AND GEN.OPERATING PROCEDURES DECATUR ALABAMA L-ORNITHINE HCL AMINOACETIC ACID DIARIZOATE SODIUM U.S.R. FACILITIES AND GENERAL OPERATING PROCEDURES SARAN COATED REGENERATED CELLULOSE FILMS TAMOXIFEN CITRATE TABLETS TOLAZAMIDE-MANUF UNDER CONTRACT FOR COSMA S.P.A. D-GLUCONIC ACID HEMI CALCIUM SALT PILOT PLANT SCALE SYNTHESIS AND PURIFICATION OF CANNABIDIOL TROCINATE 100MG & 400MG AS MANUF IN THE ST. LOUIS MISSOURI FACILS. TOLBUTAMIDE, USP AND TOLBUTAMIDE, USP MILLED -MANUF IN KALAMAZOO, MI. DANAZOL DOXYLAMINE SUCCINATE USP ZOMPIRAC SODIUM AS IT WILL BE MANUF UNDER CONTRACT FOR COSMA S.P.A. SODIUM ASCORBATE FACILITIES AND GENERAL OPERATING PROCEDURES HYDROCORTISONE ACETATE BEPRIDIL HYDROCHLORIDE THERMOPLASTIC SHEET MATERIALS IN THE GTB-BTG SERIES TERBUTALINE SULPHATE AS IT WILL BE MANUF UNDER CONTRACT FOR COSMA SPA

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4Q2012EXCEL DMF# 4749 4750 4751 4752 4753 4754 4755 4756 4757 4758 4759 I 4760 4761 4762 4763 4764 4765 I 4766 4767 4768 4769 4770 4771 4772 4773 I 4774 4775 4776 4777 4778 4779 4780 4781 4782 I 4783 4784 I 4785 I II 1/21/1983 I II II 11/5/1982 12/6/1982 I I I I A I I I II II II II II I IV I II 12/22/1982 12/6/1982 10/14/1982 12/14/1982 1/21/1983 12/29/1982 11/23/1982 1/11/1983 12/27/1982 I I I I I I A II I II II II II II I 12/10/1982 11/5/1982 10/15/1982 10/14/1982 1/10/1983 12/20/1982 12/7/1982 1/28/1983 I I I I I II II II I II II 10/18/1982 12/17/1982 12/14/1982 1/10/1983 1/6/1983 12/20/1982 KV PHARMACEUTICAL CO SICOR SPA SYLATEC UCB PHARMACEUTICALS INC PLANTEX LTD CHEM AND PHARM WORKS INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA CK FINE CHEMICALS INC RP SCHERER GRUPPO LEPETIT SPA SCHERING AG UCB PHARMACEUTICALS INC INDUSTRIA CHIMICA MILANESE SPA YUKI GOSEI KOGYO CO LTD STATUS Type SUBMIT DATE I I I I I I I I A A II II II II II IV II II II II I 11/11/1982 12/6/1982 1/4/1983 1/6/1983 1/4/1983 1/11/1983 1/11/1983 12/10/1982 11/30/1982 12/20/1982 9/27/1982 HOLDER MALLINCKRODT INC BLASCHIM SPA DIOSYNTH BV PENCO OF LYNDHURST INC BIOSEARCH LABORATORIES LTD FMC CORP LUDWIG HEUMANN AND CO GMBH SOCIETE FRANCAISE D'ORGANO BAYER SCHERING PHARMA AG GUERBET CARIBBEAN BIORESEARCH INC SUBJECT IOTHALAMIC ACID USP - MANUFACTURED IN DIEBURG NAPROXEN FENTANYL CITRATE FENTANYL CITRATE, BULK FORM VINYPYRROLIDONE CARRIERS

4Q2012

CELLULOSE ACETATE AS ANALYZED & DISTRIBUTED FROM NEWARK, DEL. FACILITY TRIMETHOPRIM DACARBAZINE HYDROCORTISONE IOXAGLIC ACID MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SAN GERMAN, PUERTO RICO. FLURBIPROFEN 200MG CAPS AS MANUF IN THE ST. LOUIS, MISSOURI FACILS. FLUOROMETHOLONE TRIVEMIL FACILITIES AND GENERAL OPERATING PROCEDURES LAURYLMETHACRYLATE-ACRYLIC ACID COPOLYMER (POLYMER TP-1980) DISOPYRAMIDE PHOSPHATE AND DISOPYRAMIDE BASE BETHANECHOL CHLORIDE FACILITIES AND GENERAL OPERATING PROCEDURES TERFENADINE AS MANUFACTURED IN THE GARESSIO (CUNEO) PLANT 4-DIMETHYLAMINO PYRIDINE CARBETAPENTANE TANNATE OXPRENOLOL HCL ISONIAZID BULK FORM

ABBOTT LABORATORIES PHARMACEUTICAL FACILS, PERSONNEL & GEN OPER PROCEDS FOR THE MURINE CO. FACILS. PRODUCTS DIV SOCIETA ITALIANA CORTICOSTEROIDI SPA FLUNISOLIDE HEMIHYDRATE PLANTEX LTD CHEM AND PHARM WORKS SCHERING AG BRIDGE CHEMICALS PCAS GANES CHEMICALS INC ICI AMERICAS INC PROCOS SPA PILOCARPINE (SOLUTION IN ACETONE) TESTOSTERONE PROPIONATE DIETHYLCARBAMAZINE CITRATE CLONIDINE HYDROCHLORIDE AS MANUFACTURED IN TURKU, FINLAND. FACILITIES AND GENERAL OPERATING PROCEDURES ARLACEL 481 &ARLACEL 986 MNFG ALAS CHEMIE IN ESSEN,GERMANY PERSONNEL, FACILS AND GEN OPERATING PROCEDURES

ABBOTT LABORATORIES PHARMACEUTICAL ETHCHLORVYNOL AS MANUF IN THE NORTH CHICAGO ILLINOIS FACILITY PRODUCTS DIV H REISMAN CORP PSEUDOEPHEDRINE HYDROCHLORIDE AS PROCESSED IN THE ORANGE, NJ FACILITY SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT OY STAR AB GUANFACINE HCL DISOPYRAMIDE PHOSPHATE

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4Q2012EXCEL DMF# 4786 4787 4788 I 4789 4790 4791 4792 4793 4794 4795 4796 4797 4798 4799 4800 4801 4802 A 4803 4804 4805 4806 4807 4808 4809 4810 4811 4812 4813 4814 4815 4816 4817 4818 4819 4820 4821 4822 4823 I 4824 I II 3/3/1983 PLANTEX LTD CHEM AND PHARM WORKS I A I I I I I I I I A I I I I I I I I I II III II III II II II III II IV II II II II II II II II II II I 12/29/1982 12/20/1982 1/14/1983 1/17/1983 1/31/1983 2/18/1983 11/16/1982 2/2/1983 1/21/1983 1/31/1983 1/6/1983 12/20/1982 8/24/1982 12/22/1982 2/22/1983 1/12/1983 12/6/1982 1/17/1983 9/17/1982 12/20/1982 3/2/1983 A A I I I I I A A A I I I II II II II II II II II II II II I III II 1/6/1983 11/26/1982 1/26/1983 1/21/1983 1/12/1983 2/1/1983 2/9/1983 1/6/1983 1/31/1983 12/22/1982 11/22/1982 1/20/1983 1/31/1983 1/24/1983 STATUS Type SUBMIT DATE I I II II II 12/15/1982 12/7/1982 1/20/1983 HOLDER SCHERING AG YUKI GOSEI KOGYO CO LTD SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP SANDOZ GMBH EVONIK TECHNOCHEMIE GMBH BRIDGE CHEMICALS OY STAR AB LEIRAS PHARMACEUTICALS CLARIANT CORPORATION TECHNOCHEMIE GMBH PHARMACIA AND UPJOHN SUB PFIZER INC DAIWA PHARMACEUTICAL CO LTD SIFAVITOR SRL INDUSTRIA CHIMICA MILANESE SPA HOUBA INC 3M PHARMS RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA SPA TEVA PHARMACEUTICAL INDUSTRIES LTD PROMENS PACKAGING LTD BAYER BALL CORP 3M PHARMS INDENA GRUPPO INVERNI DELLA BEFFA FARMABOIS BALL CORP ORGAMOL SA 3M PHARMS PHARMACIA AND UPJOHN NIPPON KAYAKU COMPANY LTD IRE NATL INST RADIOISOTOPES BAYER OMNICHEM NV (PRB) MEDI PHYSICS INC CAMBREX PROFARMACO MILANO SRL OTSUKA PHARM CO LTD IRE NATL INST RADIOISOTOPES NIPPON KAYAKU COMPANY LTD SIFAVITOR SRL SUBJECT PREDNISOLONE 21-HEMISUCCINATE NIACINAMIDE TRIFLUOPERAZINE HYDROCHLORIDE LEVOTHYROXINE SODIUM LORMETAZEPAM (MACRO)

4Q2012

TRIFLUOPERAZINE DIHYDROCHLORIDE & HCL-MFG BY BRIDGE CHEM LTD,ENGLAND METHOXSALEN TAMOXIFEN CITRATE, BULK FORM HOECHST WAX E PHARMA, BULK DRUG SUBSTANCE INTERMEDIATE FOR LORAZEPAM (WY 4088) METHYLPREDNISOLONE USP AS MANUF. IN KALAMAZOO, MICH FACILS. CHLORZOXAZONE USP AS MANUFACTURED IN TOYAMA, JAPAN AMILORIDE HCL BP 80 DEXBROMPHENIRAMINE MALEATE USP. XX METHODS,FACILS & CONTRLS-FOR PRODUCT. OF BULK AL (ACT.LIPIDS)CULVER,IN DRUG PROTECTIVE CAPS AS MANUF IN THE ST. PAUL, MINN. FACILITIES VERAPAMIL HCL PILOPEX 2 EYE DROPS PLASTIC BOTTLES AND CLOSURES ACETYLSALICYLIC ACID (ASPIRIN) BALL PLASTIC 656(TM) COEXTRUD. PACKAG. MTRLS-PRODUCED-EVANSVILLE, IND. POLYURETHANE FOAM CIRCLES AS MAMUF. IN THE ST. PAUL, MINN. FACILITIES DESERPIDINE USP MEDROXYPROGESTERONE ACETATE USPXX BALL SARAN COEXTRUSIONS AS PRODUCED IN THE EVANSVILLE, IN FACILITY ORPHENADRINE CITRATE AND ORPHENADRINE HCL. TAPE LAMINATE PACHS--MFGR IN ST. PAUL, MINN FACILS METHYLPREDNISOLONE ACETATE L-ALANINE, L-METHIONINE & GLYCINE AS MANUF IN TOKYO, JAPAN FACTORY XENON -133 GAS NIMODIPINE CAPS 10MG (BAY E 9736) VERAPAMIL HCL 1231-M-123 OR 1231-D,1-N-ISOPROPYL-P-IODOAMPHETAMINE HYDROCHLORIDE METOPROLOL TARTRATE PROCAEROL, AEROSOL FORMULATION PRODUCED IN TOKUSHIMA FACTORY MOLYBDENUM-99 L-THREONINE, L-TRYTOPHAN & L-ISOLEUCINE MANUFACTURING SITE, FACILITIES, PERSONEL & GENERAL OPERATING PROCEDURES IN MILAN, ITALY CISPLATIN Page 132

4Q2012EXCEL DMF# 4825 4826 I 4827 4828 4829 4830 4831 4832 I 4833 4834 4835 4836 4837 4838 I 4839 4840 4841 4842 4843 4844 I 4845 4846 4847 4848 I 4849 4850 4851 4852 4853 A 4854 4855 4856 4857 I 4858 4859 4860 I I I V II II 3/11/1983 4/8/1983 4/7/1983 I I I II II II I 3/7/1983 3/9/1983 2/17/1983 2/28/1983 I I A I II III IV I III 3/8/1983 3/11/1983 12/7/1982 3/17/1983 3/28/1983 SCHERING AG PERSTORP CHEMICALS AB ARCHER DANIELS MIDLAND COMPANY LANHAM PACKAGING TOTAL PETROCHEMICALS AND REFINING USA INC BOFORS AB SHOWA DENKO KK PHARMACIA AND UPJOHN INC I I I II II II I 1/4/1983 3/11/1983 3/7/1983 2/17/1983 DIOSYNTH BV SANOFI AVENTIS DEUTSCHLAND GMBH NOBEL KEMI AB AMERICAN CHEMICAL INDUSTRIAL CORP A I I I I II III III II II I 3/11/1983 1/25/1983 9/10/1982 3/7/1983 1/7/1983 1/11/1983 MALLINCKRODT INC PANTASOTE INC UNION CARBIDE CORPORATION SIGMA F AND D DIV LTD SCHERING AG CIS US INC I A I I A I II II II III I 1/11/1983 2/24/1983 2/25/1983 3/4/1983 3/10/1983 12/15/1982 A I I I I II II II II II I 3/3/1983 2/15/1983 1/26/1983 1/28/1983 12/15/1982 3/22/1983 STATUS Type SUBMIT DATE I III II 3/8/1983 2/25/1983 HOLDER 3M PHARMS BECKMAN INSTRUMENTS INC DIV SMITHKLINE BECKMAN CORPORATION REGIS TECHNOLOGIES INC ORGAMOL SA SIGMA F AND D DIV LTD KNOLL AG LUDWIGSHAFEN SCHERING AG MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC GANES CHEMICALS INC ERREGIERRE SPA SCM CORPORATION SIGMA F AND D DIV LTD REXAM HEALTHCARE DOW CHEMICAL CO MICHIGAN DIV SUBJECT HEAT SEALABLE MICROPOROUS TAPE NO. 1781 SYNTHETIC HUMAN PROINSULIN C-PEPTIDE

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4-AMINOPYRIDINE REGIS CODE #002054-PROCESSED-MORTON GROVE, ILL FACILS METHOCARBAMOL L ETHYL-3-(3-DIMETHYLAMINOPROPYL) CARBODIIMIDE HCL ST. LOUIS,MO PLANT PROPRANOLOL HCL MANUFACTURED IN LIESTAL, SWITZERLAND PREDNISOLONE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WILSON, NORTH CAROLINA. GENERAL OPERATING PROCEDS FOR PENNSVILLE, NJ FACILITY CHENO DESOXYCHOLIC ACID ENCAPSULATED POTASSIUM CHLORIDE DURKOTE KCL 150-92 ANTIPYRINE AS PRODUCED IN THE ST. LOUIS, MISSOURI PLANT ARGUS-LOC CHILD RESIST. CLOSURES-MFGR AT BROOKVILLE, PA. LOCATION MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MIDLAND, MICHIGAN. CODEINE PHOSPHATE (ESUB) MANUFACTURED IN ST. LOUIS, MISSOURI. PVC COMPD AND/OR FILM: 1. 4575 PVC CMPD AND/OR FILM MFGR IN NJ FACILS BAKELITE BRAND POLYETHYLENE (GRSN SERIES):1. GRSN-7144 NATURAL 7 ADENOSINE 5' TRIPHOSPHATE (AP) DISODIUM SALT MFG ST.LOUIS, MO PLANT MICRONIZING LORMETAZEPAM MANUAFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DEANGELO DRIVE. PROTEIN HYDROLYSATE HUMAN INSULIN-SEMISYNTHETIC, BULK MATRLS & FINISHED DOS. FORM N,N-BIS (2,3-DIHYDROXYPROPYL)-5-AMINOISOPHTALAMIDE OR (5-AIPA-DIAMIDE) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RICHMOND, CALIFORNIA. L-5-HYDROXYTRYPTOPHAN AS MANUFACTURED BY DIAMALT AG IN MUNICH UREA MOLDING CMPDS MFG IN FLORENCE,MA 1. UREA MOLDING CMPD GRADE 151 SOYBEAN OIL FACILS AND GENERAL OPERATING PROCEDS-A 20TH & L ST., S.W., WASH, DC CRYSTAL POLYSTYRENE PRODUCTS (COSDEN 535) MANUF WINDSOR, NJ FACILS N,N'-BIS (2,3-DIHYDROXYPROPYL)-5-NITROISOPHTALAMIDE CHENODEOXYCHOLIC ACID-PROCEDS FOR PRODUCTION A THE KAWASAKI WORKS TRANEXAMIC ACID

BECTON DICKINSON MONOCLONAL CENTER MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING INC PROCEDURES IN MOUNTAIN VIEW, CALIFORNIA. SANOFI AVENTIS DEUTSCHLAND GMBH PRECLINICAL STUDIES USING HUMAN INSULIN SEMISYNTHETIC (HOE 21 PH INJ) CILAG CHEMIE AG SIGMA F AND D DIV LTD BEPRIDIL HCL SELENO-DL-METHIONINE AS SUPPLIED BY SIGMA (ISRAEL)CHEMICAL COMPANY Page

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4Q2012EXCEL DMF# 4861 4862 4863 4864 4865 4866 4867 I 4868 4869 I 4870 I 4871 4872 I 4873 4874 4875 I 4876 4877 4878 I 4879 I 4880 4881 4882 4883 4884 4885 4886 4887 4888 4889 4890 4891 4892 I 4893 4894 4895 I I I II II II 8/4/1982 12/20/1982 5/9/1983 I I I I C I I I I A I I II II II II II II II II III III II II II 3/16/1983 10/14/1983 2/1/1983 4/4/1983 3/15/1983 3/1/1983 3/16/1983 3/23/1983 3/16/1983 3/16/1983 3/31/1983 3/30/1983 12/27/1982 AAI PHARMA LLC PFIZER LTD ANTIBIOTICOS SPA PLANTEX LTD CHEM AND PHARM WORKS MALLINCKRODT INC BIOREX LABORATORIES INC AAIPHARMA INC EASTMAN KODAK CO SPARTECH PLASTICS CONSTANTIA TEICH GMBH JANSSEN PHARMACEUTICA NV ASTA-WERKE AKTIENGESELLSCHAFT LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO NORDION INTERNATIONAL INC SPRET MAUCHANT LABORATORIES TROPONWERKE GMBH CO KG I 2/28/1983 BIOREX LABORATORIES INC I A II II II 2/24/1983 3/26/1983 2/21/1983 I I IV III II 3/28/1983 3/16/1983 3/21/1983 A II II 3/14/1983 3/18/1983 TEVA PHARMACEUTICAL INDUSTRIES LTD BECLOMETHASONE DIPROPIONATE ABBOTT LABORATORIES PHARMACEUTICAL SODIUM BUTABARBITAL-MANUF IN NORTH CHICAGO, ILL. FACILITIES PRODUCTS DIV MONA INDUSTRIES INC MONAMID 150-LW MANUF IN THE PATERSON, JN FACILITIES SPARTECH PLASTICS II 12/30/1982 MEDIMPEX NORTHAMERICA INC I III I 3/16/1983 11/18/1982 STATUS Type SUBMIT DATE I I I I I I II II II III II II III 1/25/1983 3/30/1983 3/31/1983 3/23/1983 12/30/1982 3/8/1983 3/21/1983 HOLDER GANES CHEMICALS INC PLANTEX LTD CHEM AND PHARM WORKS ASTRA RESEARCH LABORATORIES INEOS FILMS ITALIA SRI MEDIMPEX NORTHAMERICA INC PEBOC LTD TECHNICAL COATINGS CO SUB OF BENJAMIN MOORE & CO SPARTECH PLASTICS CELL PRODUCTS INC SUBJECT 1-EPHEDRINE SULFATE-MANUF IN THE PENNSVILLE, NJ FACILITY

4Q2012

VINCRISTINE SULFATE USP MANUF PLANTEX-NETANYA & ASSIA-PETACH TIKVA FAC OMEPRAZOLE CAPSULES PVC FILM FOR PHARMACEUTICAL PACKAGING MANUFACTURED IN SICOFORM IT HEPARIN SODIUM-AS MFGR BY CHEM. WORKS OF GEDEON RICHTER LTD, HUNGARY GUAIFENESIN USP 30049 PEEL SEAL THERMOPLASTIC SHEET TYPE RTB,BTR SERIES PRODUCED A MEDFORD,MASS FACIL MANUFACTURING SITE, FACILITIES, PERSONNEL,AND GENERAL OPERATING IN NEW BRUNSWICK, NEW JERSEY. ERGONOVINE MALEATE-MFGR BY CHEM WORKS OF GEDEON RICHTER, LTD, HUNGARY

THERMOPLASTIC SHEETS TYPE FTB,BRT SERIES MNFG MEDFORD,MASS.FACILITY

TEMMLER WERKE VEREINIGTE CHEMISCHE KETOPROFEN CR CAPSULES 200&300MG, MNFG IN MARBURG, GERMANY FABRIKEN MEDIMPEX NORTHAMERICA INC TRIMETHOPRIM AS MFGR BY EGYT PHARMACOCHEMICAL WORKS OF BUDAPEST LUNDBECK PHARMACEUTICALS ITALY SPA DINAMITE DIPHARMA SPA METOCLOPRAMIDE HCL MONOHYDRATE NAPROXEN MANUFACTURED IN THE BARANZAE DI BOLLATE (MILAN), ITALY FACILITIES MANFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LONDON ON QUEENSLAND ROAD. PROPOXYPHENE NAPSYLATE-MFGR BY ELI LILLY INDUST. INC-MAYAQUEZ, P.R. TIOCONAZOLE AS MANUF PFIZER LTD, SANDWICH, UK CHEM. & PHARMACY OF ANTIBIOTIC LM 427 AS IT WILL BE REFERENCED BY INDS VINBLASTINE SO4 USP AS MFGR IN PLANTEX-NETANYA AND ASSIA-PETACH TIKVA HYDROCODONE BITARTRATE (ESUB) AS MANUFACTURED IN ST. LOUIS, MO. CICLOXOLONE SODIUM PROPOXYPHENE HCL AS MANUF BY ELI LILLY INDUST. IN MAYAQUEZ, P.RICO 13-CIS-RETINOIC ACID (ISOTRETINOIN)-MFG IN ROCHESTER, NY FACILS THERMOPLASTIC SHEET IN MTB-BTM SERIES MNFG IN MEDFORD, MASS FACILITIES ALUMINUM FOIL PACKAGING MATERIALS MANUF LOIPERSBATCH, AUSTRIA FACILS DROPERIDOL,CODE#R4749,MNFG IN BELGIUM AND PUERTO RICO FACILITIES CORMELIAN COATED TABLETS FENBUFEN MNFG BY CYANAMID OF GREAT BRITAIN, LIMITED XENON-127 (PROD VANCOUVER, BRITISH COLUMBIA) ORIG SUBMITTED TO DMF4115 BAMIFYLLINE (TRENTADIL) ETOFENAMATE MFG IN THE KOLN, GERMANY PLANT

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4Q2012EXCEL DMF# 4896 4897 I 4898 4899 4900 4901 4902 4903 4904 I 4905 4906 4907 4908 4909 4910 4911 4912 I 4913 4914 4915 4916 4917 4918 4919 4920 4921 I 4922 4923 4924 4925 4926 I 4927 I 4928 4929 4930 4931 I A A I II II II I 3/22/1983 3/17/1983 5/19/1983 4/12/1983 HERBRAND PHARMACHEMICALS GMBH TARO PHARMACEUTICAL INDUSTRIES LTD SCHERING AG ELAN CORP PLC PROPYLTHIOURACIL CARBAMAZEPINE ETHINAMATE II 5/24/1983 I A I I II II II II I 3/17/1983 4/18/1983 4/29/1983 8/8/1983 4/13/1983 I I I I I I I I I II II II II II II III III 3/31/1983 2/15/1983 3/4/1983 5/16/1983 4/18/1983 5/10/1983 4/25/1983 2/17/1983 4/11/1983 I I I I I I A II IV I II II II II II 3/23/1983 4/7/1983 4/28/1983 2/15/1983 3/16/1983 3/31/1983 4/18/1983 4/20/1983 ORGAMOL SA MING TAI CHEMICAL CO LTD PITMAN-MOORE CO DIV ALLIED LABS INC PFIZER INC SIEGFRIED AG ABBOTT LABORATORIES ALBEMARLE CORP I I I I A I II III III II II III I 4/2/1983 3/16/1983 7/31/1984 3/10/1983 3/14/1983 3/16/1983 3/28/1983 SUMIKA FINE CHEMICALS CO LTD SPARTECH PLASTICS UNION CARBIDE CORPORATION KONGO CHEMICAL CO LTD FINE CHEMICALS CORP PTY LTD SPARTECH PLASTICS AH ROBINS CO STATUS Type SUBMIT DATE I II I 5/10/1983 5/10/1983 HOLDER OMNICHEM NV (PRB) DINAMITE DIPHARMA SPA SUBJECT PROPRANOLOL HCL MANUFACTURED IN COOPALLAAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. FOLIC ACID

4Q2012

COMPOSITE THERMOPLASTIC SHEETS OF PTR,RTP SERIES,MNFG IN MEDFORD, MASS UCAR SOLUTION VINYL RESINS L- CARNITINE HYDROCHLORIDE THIORIDAZINE HCL-MANUF IN THE CAPE PROVINCE, SOUTH AFRICA COMPOSITE THERMOPLASTIC SHEETS IN PTF,FTP SERIES;MNFG IN MEDFORD, MASS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RICHMOND, VIRGINIA. SOBREROL MICROCRYSTALLINE CELLULOSE PROCEDURES USE IN THE MANUFACTURING PERSONNEL, FACILS & GEN OPERATING PROCEDS WASHINGTON CROSSING NJ PLANT 5-ETHYL-2-DEOXYURIDINE AS MANUF.BY HEINRICH MACK,ILLERTISSEN,GERMANY METHACHOLINE CHL-MANUF AND SOLD UNDER THE SIEGFRIED LABEL VERAPAMIL AS MNFG IN N.CHICAGO, ILLINOIS PROCAINAMIDE HYDROCHLORIDE MANUFACTURED IN SOUTH HAVEN, MICHIGAN.

AYERST LABORATORIES INC DIV AMERICAN MYSOLINE (PRIMIDONE) TABLETS MANUF IN ROUSESPOINT, NEW YORK FACILS HOME PRODUCTS CORP MIKART INC ALANTA, GA. PLANT ON MARIETTA BLVD. PFIZER INC ALZA CORP VITARINE CO INC KNOLL AG LUDWIGSHAFEN OMNICHEM NV (PRB) SIGMA F AND D DIV LTD ER SQUIBB AND SONS INC FOLIENWALZWERK BRUEDER TECH AKTIENGESELLSCHAFT SCHERING AG BASF PHARMACHEMIKALIEN GMBH CO KG CHANGZHOU PHARMACEUTICAL FACTORY HOECHST MARION ROUSSEL SA WHITEWORTH TOWNE PAULSEN INC DECARBAZINE AS MANUF BY HEINRICH MACK NACHF IN ILLERTISSEN, GERMANY OSMET DELIVERY MODULES AS PRODUCED IN THE PALO ALTO, CA. FACILITIES PSEUDOEPHEDRINE HCL 120MG S.R. CAPS--MFGR IN SPRINGFIELD GARDENS, NY AMINOPHYLLINE PROPANETRIOL TRINITRATE 10% WITH LACTOSE TRIZMA HYDROCHLORIDE AS MFG IN THE ST. LOUIS, MISSOURI FACILITIES PROCEDURES FOR PACKAGING DRUG PRODUCTS ALUMINUM PACKAGING MATERIALS DEFLAZACORT (+)-PSEUDOEPHEDRINE SULFATE HYDROCHLOROTHIAZIDE-MANUF BY CHANG ZHOU PHARMACEUTICAL WORKS DEZOCINE AS MANUF IN THE VERTOLAYE, FRANCE PLANT

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MONROVIA, CALIFORNIA. TIANJIN HEBEI PHARMACEUTICAL FACTORY METRONIDAZOLE MANUFACTURED IN TIANJIN, CHINA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MONKSLAND, ATHLONE. Page

135

4Q2012EXCEL DMF# 4932 4933 4934 4935 I 4936 4937 4938 4939 I 4940 4941 4942 A 4943 I 4944 4945 I 4946 4947 4948 I 4949 4950 4951 4952 I 4953 4954 I 4955 4956 4957 4958 4959 4960 4961 I 4962 4963 4964 I I I II II III 5/20/1983 5/9/1983 3/22/1983 PAN MEDICA SA ZYMA SA PFIZER INC I I I I I I II II II II II II I 4/22/1983 4/11/1983 5/17/1983 2/15/1983 5/18/1983 5/31/1983 4/19/1983 SANOFI SYNTHELABO INC. CILAG CHEMIE AG FARMABOIS DIOSYNTH BV PHARMA-WALDHOF GMBH DAIICHI PURE CHEMICALS CO LTD SANOFI CHIMIE A II I 5/31/1983 4/21/1983 SEKISUI MEDICAL CO LTD EUDERMA SRL I I I II II I I 5/23/1983 2/15/1983 5/25/1983 4/28/1983 JT BAKER CHEMICAL CO DIOSYNTH BV FDC PRIVATE LTD AB ASTRA I I I I I 4/26/1983 4/27/1983 6/8/1983 DESITIN WERK CARL KLINKE GMBH MALLINCKRODT INC HOECHST AG I II I 1/10/1983 4/28/1983 DIOSYNTH BV AB ASTRA I 4/25/1983 SANOFI WINTHROP INDUSTRIE MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN AMBARES, FRANCE. DEXAMETHASONE ACETATE MICRO AND NON MICRO MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURESIN SODERTALFE, SWEDEN. PRODUCTION OF PHENYTOIN SODIUM, INJECT. IN HAMBURG,GER A I IV II II 3/29/1983 4/26/1983 4/29/1983 A I I II II II II 6/1/1983 1/20/1983 3/31/1983 1/21/1983 NORDIC SYNTHESIS AB DIOSYNTH BV LOFTUS BRYAN CHEMICALS LTD SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT DOW CORNING CORP SIGMA F AND D DIV LTD INDENA SPA MEPIVACAINE HCL DEXAMETHASONE MICRO AND NON-MICRO BROMPHENIRAMINE MALEATE AS MANUF. IN RAHDRUM IRELAND OXAZEPAM SILASTIC Q3-9595 LIQUID POLYMER SYSTEM-MIDLAND MI. TRIZMA BASE AS PROCESSED IN THE SAINT LOUIS, MISSOURI FACILITIES RESERPINE USP (ESUB) STATUS Type SUBMIT DATE A I I II II II II 6/1/1983 6/3/1983 3/25/1983 6/7/1983 HOLDER SA AJINOMOTO OMNICHEM NV ROUSSEL-UCLAF HEXAGON LABORATORIES INC FMC CORP SUBJECT VINCRISTINE SULFATE TESTOSTERONE PROPIONATE BEPRIDIL HCL-MANUF IN BRONX,NY

4Q2012

CELOCAL(R) CO-PROCESSED CELLULOSE GEL/CALCIUM SULFATE MANUF NEWARK ,DE

FACILS & PERSONNEL FOR THE RAD PHARM INC CYCLOTRIN ON MAHLER RD. CA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES METHENAMINE HIPPURATE-MFGR IN PHILLIPSBURG, NJ FACIL ON NO. BROAD ST. ALLOPURINOL FACILS & GEN. OPERATING PROCEDS. FOR MFGR OF BULK DRUG PRODS: W/FORMU MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. L-METHIONINE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ITALY. AMIODARONE HYDROCHLORIDE CHLORZOXAZONE TRIAMCINOLONE ACETONIDE CHENODEOXYCHOLIC ACID H.M. 5-FLUORO-URACIL,PRODUCT 4965 L-TRYPTOPHAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ARAMON. SYNTHESIS & INVEST. DOSAGE FORM PREPARATION FOR TRIPTOSINE ZY-15029 PACKAGING COMPONENTS-PRIMARILY USED IN PRODUCTION A BKLYN, NY PLANT

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4Q2012EXCEL DMF# 4965 I 4966 4967 I 4968 4969 4970 4971 I 4972 4973 4974 I 4975 4976 4977 4978 4979 4980 4981 I 4982 4983 4984 4985 4986 4987 I 4988 4989 4990 4991 4992 4993 4994 4995 4996 4997 4998 I 4999 5000 I N I 5/26/1983 I A A A I I I I A I I II II II II IV IV II II II II 6/9/1983 6/28/1983 6/21/1983 5/28/1983 6/21/1983 2/15/1983 7/13/1983 4/22/1983 6/21/1983 7/8/1983 5/9/1983 PARKE DAVIS & COMPANY RHONE-POULENC SANDOZ GMBH TEVA PHARMACEUTICAL INDUSTRIES LTD ANTIBIOTICOS SPA DIOSYNTH BV LA DREYFUS CO YODOGAWA PHARMACEUTICAL CO LTD SANDOZ GMBH SMITHKLINE & BECKMAN INC SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT PROCTER AND GAMBLE CO NOT AN ASSIGNED NUMBER FACILITIES & GENERAL OPERATING PROCEDURES (SANDY, UTAH LOCATION) I I I I I II II II II II II 6/15/1983 7/7/1983 6/30/1983 4/22/1983 6/17/1983 6/14/1983 A I I I I I II II II II II II I 7/5/1983 7/7/1983 5/13/1983 7/6/1983 5/26/1983 5/31/1983 4/11/1983 PHARMACIA AND UPJOHN SUB PFIZER INC RHONE-POULENC TANABE SEIYAKU CO LTD MEDIMPEX NORTHAMERICA INC PLANTEX LTD CHEM AND PHARM WORKS EASTMAN CHEMICAL CO I A II II I 3/31/1983 4/7/1983 6/10/1983 EGIC LABORATORY JUSTESA IMAGEN SAU ZYMA SA I I I II V II I 5/17/1983 5/18/1983 4/7/1983 5/14/1983 GLAXO PHARMACEUTICALS LTD PAN MEDICA SA GANES CHEMICALS INC COPLEY PHARMACEUTICAL INC I II I 3/14/1983 4/7/1983 BOEHRINGER MANNHEIM GMBH JUSTE SAQF STATUS Type SUBMIT DATE I 6/21/1983 HOLDER PROTER LABORATORY SPA SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN OPERA, MILAN, ITALY. D-PHENYLALANINE

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. 0/4 DIHYDROCHLORIDE DIHYDRATE (CEPHALORIDINE ROUTE-CP)-ULVERSTON PLANT PRECLINICAL ANIMAL STUDIES FOR TRIPTOSINE BEPRIDIL HCL AS MFGR IN PENNSVILLE NJ PLANT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BOSTON, MASS. ORAL ASPEGIC DIATRIZOIC ACID MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. MEDROXYPROGESTERONE ACETATE USP -MFGR IN FACILITIES ON PORTAGE RD. SUPROCLONE (37,162 RP)-MANUF IN THE VITRY SUR SEINE CEDEX FACILITIES THIOPENTAL SODIUM FOR INJECT--MANUF IN THE OSAKA, JAPAN PLANT VINBLASTINE SO4 FOR INJECT, USP 10 MG-MANUF BY GEDEON RICHTER, HUNGARY PROPRANOLOL HCL. USP. AS MANUF. IN FACILITIES DESCRIBED IN DMF.2619 METHOCARBAMOL USP AS MANUF IN THE LLANGEFNI FACILITY

INNOVATION PHARMACEUTICALS INDUSTRY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING INTL PRIVATE LTD PROCEDURES. LUSOCHIMICA S P A PROPRANOLOL HYDROCHLORIDE USP XX, NF XV RHONE-POULENC PROTER LABORATORY SPA SANDOZ PHARMS CORP DIV SANDOZ INC SIEGFRIED AG MALLINCKRODT INC SUPROCLONE CAPSULES (37, 162 RP) MANUFACTURED IN ANTOMY, FRANCE. BULK SUBSTANCE PTT-119 AS MANUF IN THE OPERA (MILANO) PLANT GUANFACINE HYDROCHLORIDE AS MFG. IN THE EAST HANOVER, N.J. FACILITY DISULFIRAM MANUF & SOLD UNDER SIEGFRIED LABEL MERCURY 195M/GOLD 195M GENERATORS-FACILS,METHDS,CONTRL FOR PREPARATION

GUAIFENESIN (GLYCEROL GUAIACOLATE)--MFGR IN USINE DE SAINT-FONS,FRANCE 7-AMINO-CEPHALOSPORANIC ACID (7-ACA) HALOPERIDOL TRIPROLIDINE HCL. BULK FORM EGG-YOLK PHOSPHOLIPID DREYCO CHEWING GUM BASE MANUF BY L.A. DREYFUS IN BISSHEIM, FRANCE CHLORZOXAZONE USP XX AS MANUF IN THE GIFU PLANT (7-ACT)--7AMINO-3-(2,5DIHYDRO-2METHYL-5-OXO-6HYDROXY-1,2,4TRIAZINE-3YL DIPHENYLPYRALINE HCL--PRODUCED IN SMITHKLINE FACILS-CONSHOHOCKEN, PA. SF86-327 (E)-N-(6,6-DIMETHYL-2-HEPTEN-4-YUL)-N--METHYL-1-NAPHTHALALENE MIAMI VALLEY LABS-EAST MIAMI RIVER RD., CINCINNATI,OHIO

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4Q2012EXCEL DMF# 5001 5002 I 5003 5004 5005 5006 5007 5008 5009 5010 5011 5012 5013 I 5014 5015 5016 5017 5018 5019 5020 5021 5022 I 5023 I 5024 5025 5026 I 5027 5028 5029 5030 5031 5032 5033 5034 5035 5036 I A I A A A C I I I II I II II II II II II IV III 5/17/1983 7/28/1983 7/29/1983 4/27/1983 6/30/1983 8/5/1983 5/19/1983 5/31/1983 5/6/1982 5/6/1982 FABBRICA ITALIANA SINTETICI SPA UCB,SOCIETE ANONYME PHARM DIV EUTICALS LIMITED JUSTE SAQF FERMION OY BASF PHARMACHEMIKALIEN GMBH CO KG DEGUSSA AG ER SQUIBB AND SONS INC SCM CORPORATION SUNOCO CHEMICAL CO A A II II I 6/28/1983 7/21/1983 7/26/1983 II 7/25/1983 A I I I I A A I III III II II II II III II II 2/1/1983 7/22/1983 4/20/1983 5/19/1983 7/29/1983 6/29/1983 5/5/1983 7/18/1983 3/22/1983 AMCOR FLEXIBLES SELESTAT BALL CORP E MERCK DEGUSSA AG JAME FINE CHEMICALS INC BASF PHARMA EVIONNAZ SA KURZ TRANSFER PRODUCTS LP ANDRULIS RESEARCH CORP I A A I I I I I I I II III II II II II IV IV II II I 5/19/1983 6/20/1983 5/3/1983 6/29/1983 6/23/1983 6/14/1983 7/11/1983 7/14/1983 8/1/1983 8/4/1983 7/29/1983 DEGUSSA AG AMERICAN GASKET AND RUBBER CO SANOFI CHIMIE SMITHKLINE BEECHAM ANIMAL HEALTH SALK INSTITUTE VITARINE CO INC PETROLITE CORP BARECO DIV KV PHARMACEUTICAL CO INNOTHERA INDUSTRIA FARMACEUTICA SERONO JAME FINE CHEMICALS INC STATUS Type SUBMIT DATE I II I 6/15/1983 5/31/1983 HOLDER GLAXOCHEM LIMITED PERSTORP CHEMICALS AB SUBJECT VITAMIN B 12(CYANOCOBALAMIN) AS MANUF IN ULVERSTON, CUMBRIA PLANT

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. L-TYROSINE ETHYLESTER HCL-BY REXIM S.A. DIV. OF DEGUSSA, HAM, ENGLAND RUBBER COMPOUNDS & GASKETS-MANUF IN SCHILLER PARK, IL AMIODARONE HCL AS MANUF BY SEMPA-CHIMIE IN ARAMON, FRANCE DIETHYLCARBAMIZINE CITRATE-MANUF-SMITHKLINE CHEM DIV-CONSHOHOCKEN PA NAL-ARG ANTAGONIST PHENYLEPHRINE HCL 20MG S.R. CAPS-MANUF IN SPRINGFIELD GARDENS, NY SILTEX M AS PROCESSED IN OKLAHOMA FACILITIES PROTECTIVE CREAMS,LOTIONS-WESTPORT FACIL. ON SCHUETZ RD, ST. LOUIS, MO CETIEDIL TP-1 SERONO (THYMOSTIMULIN) MFG BY I.F. SERONO, S.P.A. ROME, ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BOUND BROOK PLANT. ALUMINUM FOIL PACKAGING MATERIALS COEXTRUDED PKG MALS-EVANSVILLE, IND, FACIL: 1.BALL PLASTICS 454(TM) CHLORTHALIDONE USP AMINO ACID MIXTURES I AS PRODUCED BY REXIM SA DIV DEGUSSA HAM FRANCE METHENAMINE HIPPURATE MFG IN THE BOUND BROOK, N.J. FACILITIES PRILOCAINE HCL COLORIT P 912 BLACK PIGMENT FOIL-PRODUCED IN THE PHIL., PA FACILITIES BULK SYNTHESIS OF NSC 271674

SANDOZ LTD PHARMACEUTICAL DIV L(-)-POLYLACTIC ACID FOR USE IN DRUG DOSAGE FORMS CHEMICAL DEVELOPMENT WAITAKI INTERNATIONAL BIOSCIENCES SUB METOCLOPRAMIDE MONOHYDROCHLORIDE WAITAKI CANADA LTD BASF PHARMA EVIONNAZ SA BENOXINATE HYDROCHLORIDE SIFAVITOR SRL MEIJI SEIKA KAISHA LTD DOXEPINE HYDROCHLORIDE USP XX. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES FOR ANTIBIOTIC PRODUCTIONIN ASHIGARA, JAPAN LORAZEPAM, BULK FORM PERSONNEL FACILITIES & GENERAL OPERATING PROCEDURES BRAINE-L'ALLEUD ISOSORBIDE-5-MONONITRATE, DILUTED SODIUM DIATRIZOATE VERAPAMIL HCL BP 80 ADD. 82 CAFFEINE (HYDROUS, ANHYDROUS FORMS) L-ARGININE ACETATE AS PRODUCED BY REXIM S.A.DIV DEGUSSA -HAM FRANCE TRIFLUPROMAZINE AND TRIFLUPROMAZINE HCL AS MANUF BY VON HEYDEN SAINA III-PROCESSED IN JOLIET, ILLINOIS FACILITIES POLYPROPYLENE RESINS IN PP11M12ACS SERIES MANUFACTURED IN ODESSA, TEXAS.

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4Q2012EXCEL DMF# 5037 5038 A 5039 5040 5041 5042 5043 I 5044 A 5045 5046 5047 5048 5049 5050 5051 I 5052 5053 I 5054 5055 5056 5057 5058 I 5059 5060 5061 I 5062 5063 5064 5065 5066 I 5067 I 5068 5069 5070 A I I II I II 6/22/1983 7/27/1983 7/26/1983 II 8/31/1983 I I I I II II III II I 7/14/1983 9/5/1983 5/9/1983 7/22/1983 9/6/1983 A I III II II 9/9/1983 6/13/1983 8/22/1983 I I I I I I II I III 6/24/1983 7/27/1983 9/7/1983 9/1/1983 9/1/1983 EMSON RESEARCH INC SYNCOR INTERNATIONAL CORP ROUSSEL-UCLAF CONTECH LABORATORIES TECHNICAL COATINGS CO SUB OF BENJAMIN MOORE & CO INTERNATIONAL PACKING CORP FUJISAWA DEUTSCHLAND GMBH CHUNGHWA CHEMICAL SYNTHESIS & BIOTECH CO LTD SCHERING AG ANTIBIOTICOS SPA PANTASOTE INC SIGMA F AND D DIV LTD A II I 4/7/1983 4/11/1983 I A A I I A II II II II II II I 11/28/1983 6/30/1983 7/25/1983 7/22/1983 6/30/1983 7/28/1983 6/24/1983 II 8/9/1983 DAIICHI SANKYO CHEMICAL PHARMA CO LTD UCB,SOCIETE ANONYME PHARM DIV CERBIOS PHARMA SA PHARMACIA AND UPJOHN SANOFI PHARMACEUTICALS INC DIAMALT AG UCB,SOCIETE ANONYME PHARM DIV LABORATOIRES D'ETUDES ET DE RECHERCHES SYNTHELABO JUSTE SAQF SPECIALTES SEPTODONT I I A I II II II III I 7/26/1983 7/15/1983 7/9/1983 6/22/1983 5/26/1983 STATUS Type SUBMIT DATE I III II 7/12/1983 8/15/1983 HOLDER BALL CORP JOHNSON MATTHEY PHARMACEUTICAL MATERIALS ARCO CHEMICAL CO UPJOHN CO EVONIK TECHNOCHEMIE GMBH BALL CORP SCHERING CANADA INC SUBJECT COEXTRUDED PACKAGING MATERIALS-PROCESSED EVANSVILLE FACILITIES FENTANYL CITRATE (BULK) MANUF. IN WEST CHESTER, PA. FACILITIES TEBOL 99 ALCOHOL (HIGH PURITY TERTIARY BUTYL ALCOHOL) PASEDENA TX

4Q2012

MENOGAROL (U-52,047,NSC-269148)PRODUCED KALAMAZOO, MICHIGAN FACILITIES LORAZEPAM MFG IN DOSSENHEIM, GERMANY COEXTRUDED PACKAGING MATERIALS AS PROCEDURES IN EVANSVILLE IN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN POINTE CLAIRE, QUEBEC. LEVODOPA AS PRODUCED IN THE HIRATSUKA PLANT MECLIZINE HCL TABS IN BULK 12.5MG-MANUF IN BRAINE-1'ALLEUD PLANT LEUCOVORIN CALCIUM AS MANUFACTURED IN BARBENGO SWITZERLAND ESTRADIOL CYPIONATE USP MANUF-KALAMAZOO, MI FACILITIES ON PORTAGE RD. ACETAMINOPHEN S-CARBOXYMAHYL-L-CYSTEINE MECLIZINE HCL TABS-BULK 25MG MANUF -BRAINE-L'ALLEUD PLANT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PORCHVILLE, ANTONY, FRANCE. MEGLUMINE DIATRIZOATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDUES. PERSONNEL FACILITIES & GENERAL OPERATING PROCEDURES PERSONNEL, FACILITIES & GENERAL OPERATING PROCEDURES-GLENDALE CA PLANT L-5-HYDROXYTRYPTOPHAN AS MANUF,IN VERTOLAYE PLANT PERSONNEL FACILITIES & GENERAL OPERATING PROCEDURES-GREENVILLE ILL FOIL TO PVC HEAT SEAL PRODS-PRODUCED IN NUTLEY NJ FACILITIES PRODUCT BO-401-MANUF IN MORRISTOWN, IND. FACILS. ( A FORMULATION) TAMOXIFEN CITRATE ACETAMINOPHEN USP XX PWD & ACETAMINOPHEN W/10% STARCH QUINIDINE GLUCONATE MANUF. IN BERLIN PLANT FLURANDRENOLIDE USP BULK FORM (NON-STERILE) PVC COMPOUNDS AND/OR FILMS (PRO.N.J. FACILITIES):1. 4504P1000 PVC MUSCIMOLMANUF BY BACHEM AG

YAMANOUCHI PHARMACEUTICAL COMPANY PERSONNEL FACILITIES & GENERAL OPERATING PROCEDURES LTD AYERST LABORATORIES INC DIV AMERICAN GONADORELIN HCL AS MFG IN THE ROUSES POINT, NY PLANT(FACTREL) HOME PRODUCTS CORP NORDION CANADA INC LEAD & THALLIUM 201-PRODUCED IN AECL TRIDCHEM. ANNEX-VANCOUVER, CAN MEMBRANA INC DINAMITE DIPHARMA SPA PERSONNEL FACILITIES & GENERAL OPERATING PROCEDURES GUANETHIDINE MONOSULFATE

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4Q2012EXCEL DMF# 5071 5072 5073 5074 5075 5076 5077 5078 5079 5080 I 5081 5082 5083 I 5084 5085 I 5086 5087 5088 5089 5090 5091 5092 5093 5094 I 5095 5096 5097 5098 5099 5100 5101 5102 5103 5104 5105 I 5106 I II 9/20/1983 SOCIETE LIPHA I I I I I I I I I I II IV II III II III II II II II I 10/12/1983 9/14/1983 8/22/1983 9/30/1983 8/4/1983 5/26/1981 7/18/1983 9/16/1983 8/23/1983 7/25/1983 9/27/1983 I I I I I A I I II I II II II II II II II 7/29/1983 8/8/1983 8/15/1983 9/20/1983 7/20/1983 7/4/1983 10/12/1983 10/3/1983 10/10/1983 IRISH FINE CHEMICALS LIMITED ELI LILLY INDUSTRIES INC CHIREX LTD SIGMA F AND D DIV LTD ACF CHEMIEFARMA NV ZACH SYSTEM SPA BACHEM INC KABI PHARMACIA HEPAR INC RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA VITARINE CO INC VMF EPROVA AG BALL CORP EASTMAN KODAK CO 3M PHARMS SIGMA F AND D DIV LTD ELI LILLY AND CO SCHERING AG TEVA PHARMACEUTICAL INDUSTRIES LTD QUANTUM PHARMICS LTD DEXCHLORPHENIRAMINE MALEATE AS MANUF IN RAHDRUM FACILITY GENERAL OPERATING PROCEDURES FOR THE PUERTO RICO FACILITY I II II 6/24/1983 8/30/1983 EASTMAN KODAK COMPANY ROMAN INDUSTRIES COMPANY LTD I I II II I 8/11/1983 9/30/1983 7/15/1983 ORGAMOL SA SIGMA F AND D DIV LTD NATIONAL RUBBER AND BACKING CORP STATUS Type SUBMIT DATE I I I I I I I I I III III II II II II II II II I 8/19/1983 8/14/1983 7/15/1983 9/6/1983 8/22/1983 5/24/1983 9/14/1983 9/12/1983 8/24/1983 7/4/1983 HOLDER AMERICAN NATIONAL CAN CO NATIONAL STARCH & CHEMICAL CORP ORGANICHEM CORP ASTELLAS PHARMA INC MDS NORDION SUMIKA FINE CHEMICALS CO LTD VETERANS ADMINISTRATION OMNICHEM SA KLINGE PHARMA GMBH ZAMBON SPA SUBJECT

4Q2012

LACQUERED PRINTED ALUMINUM FOIL HEAT SEAL COATED PACKAGING PRODUCTS 56065/RC-803 ADHESIVE AS PRODUCED IN THE NEW JERSEY FACILITIES PHENYLEPHRINE HCL USP MANUF. IN RENSSELEAR, NY FACILITIES CEFOTETAN AS MANUFACTURED AT TAKAHAGI PLANT IODINE 125 PRODUCED IN KANATA ISOTOPE PROCESSING FACIL (AECL-KIPE) DOXEPIN USP XX MANUF IN GIFU PLANT TC-99M-PROPYLENE AMINE OXIME (TC-99M-PNAO) 5-HYDROXY-L-TRYPTOPHAN-MANUF IN COOPPALLAAN PLANT PROPRANOLOL HCL MFG BY KLINGE & CO-IRELAND;SUBSID. KLINGE PHARMA GMBH MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ALMISANO DI LONIGO (VICENZA). DISOPYRAMIDE BETAINE FREE BASE ANHYDROUS PURCHASED BY SIGMA LTD LONDON FOR USA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LONG ISLAND, NEW YORK. 5-2(3-AMINOPROPYLAMINO) ETHYL DIHYDROGEN PHOSPHOROTHIOATE TRIHYDRATE HUMAN CHORIONIC GONADOTROPIN (MFG KANAGAWA PLANT)MKD BY TOHRI & CO.LTD

PHENTERMINE BASE & HCL MANUF-FAWDON & DUDLEY NEAR CRAMLINGTON FACILS. 3,3',5-TRIIODOTHYROACETIC ACID, DIETHANOLAMINE SALT QUINIDINE BISULFATE ACETYLCYSTEINE USP XX (MFG ALMISANO DI LONIGO, VICENZA, ITALY PLANT SOMATOSTATIN; BULK FORM AS MFG IN THE TORRANCE, CALIFORNIA FACILITIES HEPARIN CALCIUMAS MFG IN THE FRANKLIN, OHIO FACILITIES DISOPYRAMIDE PHOSPHATE AS MANUFACTURED IN THE LATINA FACTORY L-LYSINE MONOHYDROCHLORIDE TABLETS AS MFG SPRINGFIELD GARDENS, NY MFG OF EMPTY GELATIN CAPSULES. BY ELI LILLY FRANCE, FERGERSHEIM, FRANCE PHOSPHORIC ACID (76541-72-5) DESIGNATED AS SR-202 COEXTRUDED PKG MATERIALS MFG EVANSVILLE, INDIANA: 1. BALL PLASTICS 858 ACETOHYDROXAMIC ACID (LITHOSTA)PROCESSED ROCHESTER, N.Y. FACILITIES HDPE CLOSURE LINER AS PROCESSED IN ST. PAUL, MINN. FACILITIES D-PANTETHINE AS MANUF BY SOGO PHARMACEUTICAL CO. FENOPROFEN CALCIUM, BULK FORM MFG TIPPECANOE LABS (LAFAYTETTE, INDIANA IOTROL USING 5-NITROISOPHTHALIC ACID AS STARTING MATERIAL CHLORTHALIDONE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN AMITYVILLE, NEW YORK. LORTALAMINE (LM 1404) AS PROCESSED IN THE LYON FACILITY

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4Q2012EXCEL DMF# 5107 I 5108 5109 I 5110 5111 I 5112 I 5113 5114 5115 I 5116 5117 A 5118 5119 5120 5121 I 5122 5123 5124 5125 5126 5127 5128 5129 5130 5131 I 5132 5133 5134 A 5135 5136 5137 I 5138 5139 A A II II 10/27/1983 7/20/1983 I I II II I 9/28/1983 9/16/1983 5/27/1983 I I II II II 10/21/1983 10/7/1983 6/10/1983 I I I I I I I I A II II III II II II II II II II 8/26/1983 9/30/1983 8/31/1983 11/7/1983 11/3/1983 11/7/1983 11/5/1983 10/21/1983 9/30/1983 6/30/1983 I I I III II II II 9/19/1983 9/20/1983 10/14/1983 10/11/1983 A IV III 5/23/1983 9/14/1983 GATTEFOSSE SAS THE NIPPON SYNTHETIC CHEMICAL INDUSTRY CO LTD OWENS ILLINOIS INC SIGMA F AND D DIV LTD KABI PHARMACIA HEPAR INC MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC FARCHEMIA SMITHKLINE & BECKMAN INC ALLERGAN PHARMACEUTICAL CHINOIN GANES CHEMICALS INC HOECHST AG PENINSULA LABS HEINRICH MACK NACHF INOLEX CHEMICAL CO SOCIETA ITALIANA MEDICINALI SCANDICCI (SIMS) SUMIKA FINE CHEMICALS CO LTD SIGMA F AND D DIV LTD RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA SALSBURY CHEMICALS INC SYNTHA I I II II I 9/15/1983 9/20/1983 9/12/1983 GOEDECKE AG LIPHA SA L PERRIGO CO I 6/22/1983 CYANAMIDE OF CANADA I II I 8/26/1983 8/31/1983 I II II 9/9/1983 9/2/1983 JANSSEN PHARMACEUTICA NV SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT AMERSHAM RADIOCHEMICAL CENTER THATCHER CHEMICAL COMPANY STATUS Type SUBMIT DATE I 9/15/1983 HOLDER AMIDE PHARMACEUTICAL INC SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LITTLE FALLS, NEW JERSEY. OXATOMIDE-R 35443 AS PROCESSED IN THE BELGIUM FACILITY CHLORTHALIDONE AS MFG. IN THE BASLE, SWITZERLAND FACILITIES TAURO-23-[75SE]-SELENA-25 HOMOCHOLIC ACID (DESIGNATED AS SEHCA) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDUES IN SALT LAKE CITY, UTAH. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BAIE D'URFE, QUEBEC CANADA. LEVOBUNOLOL HYDROCHLORIDE (1-BUNOLOL HYDROCHLORIDE)

4Q2012

LORTALAMINE (LM 1404) IN FINISHED DOSAGE FORMS PRODUCED LYON FACILITY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ALLEGAN, MICHIGAN. PRECIROL A05 MANUFACTURED IN CEDEX,FRANCE ETHYLENE-VINYLACETATE-VINYLALCOHOL COPOLYMER (TRADE NAME SOARNOL) PLASTIC PRODUCTS MFG IN THE KALAMAZOO, MICHIGAN FACILITIES,KILGORE RD DEHYDROISOANDROSTERONE-3-SULFATE,SODIUM SALT MFG SYNTEX S.A.OF MEXICO CHONDROITIN SULFATE AS MFG IN THE FRANKLIN, OHIO FACILITIES BULK FORM OF DRUG PRODUCT L-590,153 PROCESSED RAHWAY, N.J. FACILITIES GUANETHIDINE SULFATE, USP CIMETIDINE MFG BY FRANKLIN CHEMICALS, LTD IN THE BAHAMAS CONTAINER/CLOSURE INFO PERTAINING TO CONTAINER/CLOSURE SYSTEMS HYDROCHLOROTHIAZIDE MFG DIOSGYOR, HUNGARY PLANT, DIST. BY MEDIMPEX ESMOLOL HYDROCHLORIDE AS MFG IN THE CARLSTADT, NEW JERSEY FACILITIES CHLORZOXAZONE, BULK FORM SYNTHETIC SOMATOSTATIN AS SYNTHESIZED IN BELMONT, CA. FACILITIES 5-AZACYTIDINE MFG BY HEINRICH MACK NACHFIN ILLERTISSEN, GERMANY AMMONIUM LACTATE MFG IN PHILADELPHIA PA AND SELMA,NC HYDRALAZINE CHLORIDRATE MFG IN FILARONE REGELLO (FRANCE) PLAN ISOPROTERENOL HYDROCHLORIDE USP XX AS MANUFACTURED IN THE GIFU PLANT HEPES, FREE ACID AND HEPES, SODIUM SALT DOPAMINE HCL PRODUCED CAMPOVERDE DI APRILIA, LATINA FACILITY PROBENECID USP AS MFG IN THE CHARLES CITY, IOWA FACILITY METHOCARBAMOL

TEMMLER WERKE VEREINIGTE CHEMISCHE PANCREOLAURYL TEST FABRIKEN SANOFI CHIMIE CYANOCOBALAMIN AS MFG IN ROMAINVILLE, FRANCE(PLANTS I AND IV) SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL PROPRANOLOL AS MANUF IN THE FILARONE, REGGELLO FACILITIES

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4Q2012EXCEL DMF# 5140 I 5141 5142 I 5143 5144 I 5145 5146 5147 A 5148 5149 I 5150 I 5151 5152 I 5153 5154 5155 5156 5157 5158 I 5159 5160 5161 A 5162 5163 5164 A 5165 5166 5167 5168 5169 5170 I 5171 5172 I I IV II 9/15/1983 11/25/1983 I I I I I II II V II II II 11/10/1983 11/29/1983 12/1/1983 12/20/1983 12/15/1983 11/24/1983 I I II II II 12/1/1983 12/1/1983 11/24/1983 I I II II II 12/5/1983 12/7/1983 12/1/1983 I I I I I II II III II II II 11/15/1983 11/21/1983 11/30/1983 9/22/1983 11/23/1983 10/3/1983 ELI LILLY INDUSTRIES INC KABI PHARMACIA HEPAR INC WHEATON INDUSTRIES BIOTEK INC GLAXOCHEM LIMITED I II I 9/16/1983 10/21/1983 DIOSYNTH BV APPLIPHARM I 9/22/1983 BIOTEK INC I II I 11/10/1983 9/15/1983 I I II II II 10/18/1983 8/11/1983 10/28/1983 SCHERING AG SIGMA F AND D DIV LTD SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL RHONE-POULENC AMERICAN THERAPEUTICS INC I II I 11/16/1983 11/14/1983 HOECHST AG ORION CORP FARMOS CHEMICAL PLANT I II I 11/15/1983 10/26/1983 FINE CHEMICALS CORPORATION ZENITH LABORATORIES INC STATUS Type SUBMIT DATE I 9/23/1983 HOLDER NOMAX INC SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ST. LOUIS, MISSOURI. VERAPAMIL HYDROCHLORIDE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CIDRA, PUERTO RICO. 6-AMINOPENICILLANIC ACID (6-APA) BULK FORM MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TURKU, FINLAND. SALAZOSULFAPYRIDINE AS PRODUCED IN THE BERGKAMEN PLANT

4Q2012

CHOLESTEROL AS MFG BY SIGMA CHEMICAL COMPANY IN ST. LOUIS, MISSOURI TETRAHYDROZOLINE HCL MFG IN THE FILARONE REGELLO (FLORENCE) PLANT ACETAMINOFEN AS MANUFACTURED IN THE USINE DE SAINT-FONS PLANT SITE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BOHEMIA, NEW YORK. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WOBURN, MASSACHUSETTS. ORG 7417 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MARSEILLE, FRANCE. CINOXACIN, BULK FORM AS MFG IN THE TIPPECANOE LABS LAFAYETTE, INDIANA RD HEPARIN AS PRODUCED IN THE FRANKLIN, OHIO FACILITIES GLASS LUBRICITY COATINGS/MILLVILLE,NJ FACILS/PHARMACOTE-P AND W LEVONORGESTREL MICROCAPSULES AS MFG IN THE WOBURN, MA. PLANT BETAMETHASONE DIPROPIONATE PRODUCED IN THE MONTROSE, SCOTLAND PLANT

TEMMLER WERKE VEREINIGTE CHEMISCHE DIETHYLPROPION-HYDROCHLORIDE AS MFG IN THE MARBURG PLANT FABRIKEN DANISCO INGREDIENTS SODIUM VALPROATE TRAVENOL LABORATORIES INC 20% MCT INTRAVENOUS FA EMULSION AS PROCESSED IN THE ILLINOIS FACILITY CHINOIN PHARMACEUTICAL AND CHEMICAL L-DEPRENYL MFG CHINOIN & SOLD BY MEDIMPEX IN HUNGARY & UNITED STATES WORKS PRIVATE CO LTD GIVAUDAN SA PARSOL 1789 (AVOBENZONE) MANUFACTURED IN GENEVA SWITZERLAND ROUSSEL-UCLAF SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL AIWA CHEMICAL CO LTD INDUSTRIAS QUIMICAS ESTEVE SA GIVAUDAN SA SCHERING AG DUPHAR BV SOCIETA ITALIANA MEDICINALI SCANDICCI (SIMS) GATTEFOSSE ESTABLISSEMENTS JANSSEN PHARMACEUTICA NV COLCHICINE AS MFG A THE VERTOLAYE, FRANCE PLANT MEPIVACAINE HCL AS MFG IN THE FILARONE, REGELLO (FLORANCE) PLANT CHLOFIBRATE USP AS MFG IN THE YAMATO CITY, KANAGAWA PLANT (JAPAN) IBUPROFEN AS MFG IN THE BARCELONA, SPAIN PLANT TOXICOLOGY OF PARSOL 1789 PARTS A & B AS STUDIED BY GIVAUDAN S.A. CYPROTERONE ACETATE AS PRODUCED IN THE BERLIN-WEDDING PLANT FLUVOXAMINE MATEATE MANUFACTURED IN WEESP, THE NETHERLANDS. PIRFENIDONE PRODUCTION OF GELUCIRE 62/05; TOXICITY DATA INCLUDED ASTEMIZOLE-R 43512 AS MFG IN GEEL AND BEERSE, BELGIUM PLANTS

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4Q2012EXCEL DMF# 5173 5174 5175 I 5176 5177 5178 I 5179 5180 5181 5182 5183 5184 5185 5186 5187 5188 5189 5190 5191 5192 5193 I 5194 5195 5196 5197 I 5198 5199 5200 I 5201 I 5202 5203 5204 5205 5206 I 5207 I I 12/7/1983 A I A I II II II II I 1/3/1984 1/3/1984 12/22/1983 1/11/1984 1/11/1984 PHARMACIA AND UPJOHN SUB PFIZER INC HEINRICH MACK NACHF EXCELLA GMBH ORION CORP FARMOS CHEMICAL PLANT USV LABORATORIES INC SUB RORER GROUP LTS LOHMANN THERAPIE SYSTEME GMBH I 1/3/1984 FRESENIUS USA INC C I II II I 10/26/1983 9/15/1983 1/4/1984 MALLINCKRODT INC MARION LABORATORIES INC SYLATEC I I A II II II I 8/31/1983 12/21/1983 12/13/1983 11/14/1983 TAKEDA CHEMICAL INDUSTRIES LTD KYORIN PHARMACEUTICAL CO LTD ALBEMARLE CORP SPECTRUM COLORS INC I A I A I I I I I I I I I I II III II IV II III II II I I II II V II I 12/13/1983 7/22/1983 12/27/1983 10/31/1983 9/15/1983 11/23/1983 10/26/1983 9/27/1983 11/3/1983 12/22/1983 12/20/1983 9/15/1983 9/8/1983 10/26/1983 10/17/1983 A I II II I 12/19/1983 11/4/1983 11/30/1983 ORGANICHEM CORP SIBEFAT SPA LABORATORY FOR ANALYTICAL BIOLOGY INC SALK INSTITUTE HENKEL CORP WARD BLENKINSOP AND CO LTD GATTEFOSSE SAS MARION LABORATORIES INC MALLINCKRODT INC FOREST LABORATORIES INC SYLATEC JANSSEN INC B BRAUN MEDICAL INC SOCIETE FRANCAISE D'ORGANO MARION LABORATORIES INC SANDOZ PHARMS CORP DIV SANDOZ INC FOREST LABORATORIES INC JACOBUS PHARMACEUTICAL CO STATUS Type SUBMIT DATE I I IV III I 11/28/1983 9/12/1983 12/15/1983 HOLDER SHIONOGI QUALICAPS INC FISONS PHARM LTD PHARMACHEMIE BV SUBJECT THE MANUFACTURE OF EMPTY GELATIN CAPSULES BY ELI LILLY MEXICO HALERMAIC DEVICE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HAARLEM, HOLLAND. ENCAINIDE HCL AS MFG IN THE RENSSELAER, NEW YORK FACILITY ACEPROMAZINE MALEATE AS MFG IN THE TRIBIANO (MILANO) FACILITIES NITROGLYCREINE ANALYSIS IN PLASMA CARRIED OUT BY LAB IN GERMANY

4Q2012

NORLEUCINE 27, HUMAN PANCREAIC GROWTH HORMONE RELEASING FACTOR (NG-29 ADHESIVE PRODUCTS AS MANUFACTURED IN SAEGERTOWN, PA AND ELGIN, IL. CARISOPRODOL AS MFG IN THE HALEBANK (WIDNES, CHESHIRE PLANT) LABRAFIL M 2130 CS MANUFACTURED IN CEDEX,FRANCE PHENYLPROPANOLAMINE 50 MG.TABS (MFG IN KANSAS CITY, MISSOURI FACILITY) PLASTIC SYRINGES C RUBBER CLOSURES (PKG OF CONTRAST MEDIA)RALEIGH,N.C. FLURBIPROFEN 100 MG C.R.TABS (IN SYNCHRON VEHICLE)MFG INWOOD, N.Y. INJECTABLE ASPEGIC PERSONNEL, FACILITIES & GENERAL OPERATING PROCEDURES (GURABO, P.R.) MOIST HEAT STERILIZATION PARAMETRIC RELEASE PROGRAM (CA AND GA PLANTS) CISPLATIN PHENYLPROPANOLAMINE 150 MG CAPS MFG KANSAS CITY, MISSOURI FACILITY DATA FOR THE PHARMACOLOGY,TOXICOLOGY AND METABOLISM OF SOLULAN C-24 FLURBIPROFEN 200 MG C.R. TABS (IN SYNCHRON VEHICLE)MFG INWOOD, N.Y. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PLAINSBORO, NEW JERSEY. STERILE ANHYDROUS SODIUM CARBONATE AS MFG IN THE HIKARI PLANT NORFLOXACIN MANUFACTURED AT OKAYA PLANT,NAGANO, JAPAN BENZONATATE USP XX MFG SOUTH HAVEN, MICHIGAN FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KALAMAZOO, MICHIGAN. COMPAP L (ESUB) AS PROCESSED IN THE RALEIGH, N.C. FACILITIES PHENYLPROPANOLAMINE 100MG CAPS MFG KANSAS CITY, MISSOURI FACILITY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. DINOPROSTONE SYNTHETIC (BULK) MFG KALAMAZOO, MI FACILITIES (PORTAGE RD MITOXANTRONE DIHYDROCHLORIDE MANUFACTURED IN ILLERTISSEN. TAMOXIFEN CITRATE (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY IBUPROFEN MFG BY FARMOS GROUP LTD/MEDIPOLAR IN OULU, FINLAND MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MANATI, PUERTO RICO FACILITY ON SAN JOSE ROAD. MANUFACTURING SITE, FACILITIES, PERSONNEL, GENERAL OPERATING PROCEDURES IN NEUWEID, FEDERAL REPUBLIC OF GERMANY.

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4Q2012EXCEL DMF# 5208 5209 5210 5211 I 5212 5213 5214 5215 5216 I 5217 I 5218 5219 I 5220 I 5221 5222 5223 5224 5225 I 5226 I 5227 5228 I 5229 5230 5231 5232 5233 5234 5235 5236 5237 5238 5239 5240 5241 5242 I I I I I I I I I I I A I I III IV II II II II II II IV II V II II II 2/9/1984 11/15/1983 2/22/1984 12/27/1983 2/17/1984 2/20/1984 1/25/1984 2/10/1984 1/20/1984 2/16/1984 2/27/1984 2/9/1984 3/19/1984 1/24/1984 PANTASOTE INC ICI AMERICAS INC MONSANTO POLYMER PRODUCTS CO IBARAKI KASEI COMPANY LTD MALLINCKRODT INC ROHM AND HAAS CO ORGAMOL SA SHOWA INDUSTRY COMPANY LTD SUTTON LABORATORIES DYNAMIT NOBEL AKTIENGESELLESCHAFT STERIS-ISOMEDIX SERVICES BASF PHARMA EVIONNAZ SA FINE CHEMICALS CORPORATION ACF CHEMIEFARMA NV PVC FILMS MFG PASSAIC, N.J. FACILITIES: 1. 7506H4347 PVC FILM I II II 12/20/1983 1/18/1984 II 1/20/1984 I I A I II I II II II 12/29/1983 1/19/1984 12/16/1983 1/18/1984 12/5/1983 I 1/17/1984 I II II 12/16/1983 12/23/1983 II 12/1/1983 SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT AINC I I I I II II III II I 12/1/1983 6/15/1983 11/22/1983 11/21/1983 12/9/1983 SIEGFRIED AG SIGMA F AND D DIV LTD DOW CORNING CORP SCHERING AG DAIICHI SEIYAKU CO LTD STATUS Type SUBMIT DATE A I I II IV I I 1/9/1984 12/30/1983 1/26/1984 2/8/1984 HOLDER FABBRICA ITALIANA SINTETICI SPA JRS PHARMA LP ISOMEDIX INC CUSTOM CHEMICAL LABORATORIES INC SUBJECT OXAZEPAM,BULK FORM AS PRODUCED IN THE VICENZA FACILITIES

4Q2012

EMCOMPRESS (DIBASIC CALCIUM PHOSPHATE, DIHYDRATE USP XX)MFG IN ENGLAND FACILITIES & CONTROLS FOR IRRADIATION PROCESSING(PLANT IN PUERTO RICO) MANUFACTURING SITE, FACILITIES, PERSONNEL , AND GENERAL OPERATING PROCEDURES IN INDIANAPOLIS PLANT ON GUION ROAD. AMILORIDE HCL AS MFG AND SOLD UNDER THE SIEGFRIED LABEL PYRIDOXAL 5-PHOSPHATE MFG BY DE. BI. DERIVAI BIOLOGICI INT'L S.P.A. EXPERIMENTAL LATEX XD 30612.05 PRODUCED MIDLAND, MICHIGAN FACILITIES MICRONIZED PREDNISONE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SHIZUOKA JAPAN. NAFTIFINE HCL (SN 105-843 CH) PRODUCED IN THE BASLE, SWITZERLAND PLANT ZETAPREP DEAE-CELLULOSE ION EXCHANGE MEDIA (PRODUCED CT. FACILITIES)

WAITAKI INTERNATIONAL BIOSCIENCES SUB 5-AMINOSALICYLIC ACID MFG BY DELMAR CHEMICALS,LASALLE, QUEBEC FACILITY WAITAKI CANADA LTD AYERST WYETH PHARMACEUTICALS INC MANUFACTURING SITE, FACILITIES,PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GUAYAMA, PUERTO RICO. HEICO CHEMICALS DIV WHITTAKER CORP POTASSIUM CHLORIDE MFG IN THE DELAWARE WATER GAP, PA. FACILITIES MALLINCKRODT INC FIS FABBRICA ITALIANA SINTETICI SPA UPJOHN CHEM CO SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT RUETGERS-NEASE CHEMICAL COMPANY INC GANES CHEMICALS INC DOW CORNING CORP BIOLOGICAL INDICATOR PROGRAM APPLIED MARYLAND HEIGHTS, MO PLANT SITE TEMAZEPAM, BULK FORM ESMOLOL HCL AS MFG IN THE KALAMAZOO, MICHIGAN FACILITIES, PORTAGE ROAD RS-86 AMPULS 10 MG/ML AS PRODUCED IN THE BASLE, SWITZERLAND PLANT ZINC PYRION - NS AS MANUFACTURED IN THE STATE COLLEGE, PA. FACILITIES VERAPAMIL HYDROCHLORIDE AS MFG AND SOLD UNDER THE SIEGFRIED LABEL ION EXCHANGE RESINS (DOWEX TRADE MARK) MANUFACTURED IN MIDLAND, MICHIGAN.

BRIJ 93 (POLYOXYETHYLENE (2) OLYL ETHER) MFG NEW CASTLE,DE FACILITIES LACTIC ACID, BULK FORM MFG IN THE TEXAS CITY, TEXAS FACILITIES THE MANUFACTURE AND QUALITY CONTROL OF CHLORZOXAZONE CODEINE SULFATE AS MANUFACTURED IN THE SAINT LOUIS, MISSOURI PLANT AMBERLITE IRP-69 & AMBERLITE IRP-70 (MFG PHILA PA. ON RICHMOND ST.) ALLOPURINOL DIMETHYL SULFOXIDE (DMSO-P) MFG MORIYAMA CITY FACILITIES GERMALL 115 (IMIDUREA NF) MFG CHAHAM, N.J. FACILITIES NITROGLYCERINE 10% IN LACTOSE CONTRACT STERILIZATION FACILITY IN WHITBY, ONTARIO, CANADA CARISOPRODOL TRIFLUOPERAZINE HCL SULFADIMIDE PH EUR/SULFAMETHAZINE USP

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4Q2012EXCEL DMF# 5243 I 5244 5245 5246 5247 5248 5249 5250 I 5251 5252 I 5253 5254 5255 5256 5257 5258 5259 I 5260 5261 5262 I 5263 5264 5265 5266 I 5267 I 5268 5269 5270 5271 5272 5273 I 5274 5275 5276 5277 A I A I II IV II II 3/1/1984 1/31/1984 3/2/1984 2/21/1984 HOVIONE FARMACIENCIA SA GATTEFOSSE ESTABLISSEMENTS DYNAMIT NOBEL GMBH HOUBA INC I I I I I II IV II I II I 10/20/1983 8/12/1983 11/29/1983 2/21/1984 3/2/1984 3/8/1984 INDUSTRIA CHIMICA PROFARMACO SPA SIGMA F AND D DIV LTD DIOSYNTH BV HOUBA INC NATL INST HLTH NCI GALIBIA SPA I 2/17/1984 STERIS-ISOMEDIX SERVICES I I I I II II I 12/1/1983 7/27/1983 1/18/1984 2/7/1984 PREMIUM PLASTICS INC SIGMA F AND D DIV LTD PFANSTIEHL LABORATORIES INC SCHNELL PLASTIC INC I A III II I 1/25/1984 1/23/1984 1/18/1984 3M PHARMS MERCK AND CIE VAN DYK AND CO INC A I I I I I IV II II II II II I 12/28/1983 1/16/1984 2/23/1984 1/30/1984 5/11/1983 7/20/1983 2/8/1984 I II I 2/9/1984 1/24/1984 I I I I I I II III III II II II II 2/9/1984 1/20/1984 1/25/1984 2/7/1984 1/11/1984 1/3/1984 12/15/1983 STATUS Type SUBMIT DATE II 12/7/1983 HOLDER SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT CIBA GEIGY LTD LABLABO ARTEK SYSTEMS CORP BIOCHEMIE GMBH DAIICHI SEIYAKU CO LTD PHOTOFRIN INC SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT CIBA GEIGY LTD PATHEON INC TORONTO REGION OPERATIONS GATTEFOSSE SAS SANOL-SCHWARZ SANOFI WINTHROP INC MORINAGA MILK INDUSTRY COMPANY LTD SANTEN PHARMACEUTICAL CO LTD SIGMA F AND D DIV LTD WATSON LABORATORIES INC SUBJECT RS-86 HYDROBROMIDE AS PRODUCED IN THE BASLE, SWITZERLAND PLANT CGP LL637 ADJUVANT--CHEMISTRY & GMP METERED AEROSOL VALVES GENERATOR FLUID PAH KITS AS MFG IN THE FARMINGDALE, N.Y. FACILITY

4Q2012

7-ACA, BULK FORM (7-AMINOCEPHALOSPORANIC ACID)MFG FRANKFURT MAIN PLANT DL 8280 MEFOXACIN ACTIVE & PLACEBO TABS DIHEMATOPORPHYRIN ETHERS (DHE) TRADE NAME, PHOTOFRIN II RS-86 CAPSULES IN 0.25 MG AND 1.0 MG (BASLE, SWITZERLAND PLANT) ADJUVANT CGP 11637:TOXICITY STUDIES & RESULTS CONDUCTED IN EUROPEAN FA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MISSISSAUGA, ONTARIO, CANADA. GELUCIRE 44/14; GELUCIRE 50/02 AND GELUCIRE 50/13 DEPONIT NITROGLYCERINE TRANSDERMAL THERAPEUTIC SYSTEM (MONHEIM PLANT) TYROPANOATE SODIUM MFG IN THE DUDLEY NEAR CRAMLINGTON PLANT SITE LACTULOSE SYRUP (MLS-50) AS MANUFACTURED IN THE FUJI PLANT TROPICAMIDE MYDRIAIC MFG FOR SANTEN BY OKAMI CHEM INDUSTRY CO LTD. INDOMETHACIN AS MFG BY CO. FARMACEUTICA MILANESE S.P.A. MANUFACTURING SITE, FACILITIES , PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LIBERTYVILLE, ILLINOIS. SCOTCHPAR BRAND FILMS AS MANUFACTURED IN THE MINNESOTA FACILITIES CALCIUM FOLINATE (CALCIUM LEUCOVORIN) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BELLEVILLE, NEW JERSEY. SOP FOR MFG PKG MATERIALS (EAST BRUNSWICK, N.J.) PRODUCT INFO INCLUDED STEARYLAMINE AS PROCESSED BY ARMAK FOR SIGMA F & D 5-THIO-D-GLUCOSE AS MFG IN THE WAUKEGAN, ILLINOIS FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HUNTINGTON BEACH, CALIFORNIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CERIANO LAGHETTO PLANT. ACETYL OXIDE (OXAZEPAM INTERMEDIATE) MFG IN THE PAULLO (MILANO) PLANT L-ALPHA-PHOSPHATIDYLCHOLINE, TYPE III-E (HEXANE SOLUTION) L-ALPHA-METHYLDOPATE HYDROCHLORIDE FACILITIES & GENERAL OPERATING PROCEDURES ON STATE ROAD, CULVER,IN. 3% URIDINE INJECTION (NSC 20256) AS USED WITHIN NCI OF NIH MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GALIBI-TODI. BETAMETHASONE 17,21-DIPROPIONATE AS PRODUCED IN THE LISBON FACILITIES' TEFOSE 2561 NITROGLYCERINE 5% IN MIGLYOL 812 NEUTRAL OIL MFG LEVERKUSEN PLANT ETIOCHOLANOLONE (3,-ALPHA-HYDROXY-5,-BETA-ANDROSTAN-17-ONE)CULVER,IND

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4Q2012EXCEL DMF# 5278 5279 I 5280 5281 I 5282 5283 5284 5285 5286 I 5287 5288 I 5289 I 5290 5291 5292 5293 5294 5295 I 5296 5297 I 5298 5299 I 5300 5301 I 5302 I 5303 I 5304 I 5305 5306 5307 I I I II IV I 3/14/1984 3/12/1984 3/30/1984 I 2/8/1984 VICKS HEALTH CARE DIV RICHARDSON VICKS INC ASTA-WERKE AKTIENGESELLSCHAFT ELAN CORP PLC I 11/21/1983 SIPSY CHIMIE FINE S.C.A. I 2/24/1984 SKYLAND SCIENTIFIC SERVICES INC I II I 3/16/1984 9/29/1983 I II I 3/23/1984 2/14/1984 ORION CORP FARMOS CHEMICAL PLANT COOPERVISION DIV COOPER LABORATORIES INC PENCO OF LYNDHURST INC EXPANSIA I II I 3/15/1984 1/9/1984 I I I I I II IV III I II II 3/12/1984 9/15/1983 3/29/1984 3/16/1984 12/28/1983 3/18/1984 I 3/9/1984 I II I 2/17/1984 3/7/1984 H REISMAN CORP A I I I II II II II I 2/27/1984 11/2/1983 8/12/1983 2/28/1984 2/27/1984 FIS FABBRICA ITALIANA SINTETICI SPA DIOSYNTH BV SIGMA F AND D DIV LTD EASTMAN KODAK CO APPLIED LABORATORIES INC I II I 4/20/1984 3/31/1984 ALDRICH CHEMICAL COMPANY INC NITA PHARMACEUTICAL LTD STATUS Type SUBMIT DATE A II II 2/17/1984 3/8/1984 HOLDER NORDION CANADA INC INDUSTRIA FARMACEUTICA SERONON SPA SUBJECT XENON-133 AS PROCESSED IN THE KANATA ISOTOPE PROCESSING FACILITY

4Q2012

HUMAN MENOPAUSAL GONADOTROPIN (HMG)PROCESSED IN THE GALIBIA-TODI PLANT PENTAMIDINE ISETHIONATE (PRODUCT W149-5) MFG MILWAUKEE, WI.FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FREEPORT, GRAND BAHAMA. FLURAZEPAM HCL PRODUCED IN THE VICENZA FACILITIES ANDROSTERONE ETHANOL SOLUTION OF CARDIOLIPIN SODIUM SALT (SIGMA CHEMICAL COMPANY) N-(4-HYDROXYPHENYL)-ALL-TRANS-RETINAMIDE(HPR;4-RETINOYLAMINOPHENOL) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN COLUMBUS, INDIANA. TRIPROLIDINE HYDROCHLORIDE AS MFG IN THE ORANGE, NEW JERSEY FACILITIES

BEECHAM LABORATORIES DIV OF BEECHAM MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING INC PROCEDURES IN IRVINE, SCOTLAND. CONTINENTAL PLASTICS INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DALLAS PIKE INDUSTRIAL PARK, TRIADELPHIA, WEST VIRGINIA. KABI PHARMACIA HEPAR INC PREGNANT MARE SERIUM GONADOTROPIN AS PROCESSED FRANKLIN,OH.FACILITIES SIGMA F AND D DIV LTD NOVA CHEMICALS LTD KIRBY WARRICK PHARMACEUTICAL LTD DIOSYNTH BV KRKA PHARMACEUTICAL & CHEMICAL WORKS BAYER SCHERING PHARMA AG JANSSEN PHARMACEUTICA INC L-ALPHA-PHOSPHATIDYLCHOLINE, TYPE IV-S (SIGMA CHEMICAL COMPANY) POLYSTYRENE PRODUCTS MFG SARNIA, ONTARIO FACILITIES:1. POLYSAR 203 FACILITIES AND PROCEDURES FOR CONTRACT MANUFACTURING CORTICOSTERONE NIFEDIPINE MEGESTROL ACETATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES FOR LITTLE ISLAND, COUNTY CORK (IRELAND). CYCLOPHOSPHAMIDE 50 MG TABLETS AS MFG IN THE TURKU FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MOUNTAIN VIEW, CALIFORNIA. CODEINE PHOSPHATE MFG NEWARK, N.J. FACILITIES ON MT. OLIVET AVENUE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES ARAMON, FRANCE. MANUFACTURING SITE, FACILITEIS, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BELGRADE, MONTANTA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN AVRILLE, FRANCE. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HABORO, PENNSYLVANIA. MESNA AMPOULES AS MANUFACTURED IN THE KUNSEBECK PLANT ELANPRES CAPSULES AS MANUFACTURED IN THE MONKSLAND, ATHLONE FACILITY

IOLAB PHARMACEUTICALS SUB JOHNSON & MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING JOHNSON CO PROCEDURES IN SAN GERMAN, PUERTO RICO (NORTE INDUSTRIAL PARK)

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4Q2012EXCEL DMF# 5308 I 5309 5310 5311 5312 I 5313 5314 5315 I 5316 5317 I 5318 5319 5320 5321 5322 5323 5324 5325 5326 C 5327 5328 5329 5330 5331 5332 5333 I 5334 5335 5336 5337 5338 5339 5340 I 5341 5342 I I III I 4/12/1984 4/17/1984 NUODEX INC SOLCO BASLE LTD I A I I I I II II I II II II II 4/17/1984 4/13/1984 4/13/1984 4/11/1984 12/7/1983 2/15/1984 4/9/1984 PERSTORP CHEMICALS AB SA AJINOMOTO OMNICHEM NV SHOWA DENKO KK KYOWA HAKKO KOGYO CO LTD DIOSYNTH BV HEXAGON LABORATORIES INC HOUBA INC A I I I I A II II II II II III I 3/27/1984 3/30/1984 10/7/1983 4/13/1984 3/15/1984 2/28/1984 4/5/1984 LUSOCHIMICA SPA INDUSTRIA CHIMICA MILANESE SPA SIGMA F AND D DIV LTD KABI PHARMACIA HEPAR INC NANIWA RUBBER CO LTD MAPRIMED SA I A I I A I I I II II II II II III III II II 4/5/1984 4/6/1984 4/6/1984 1/26/1984 4/2/1984 4/12/1984 3/23/1984 3/15/1984 4/5/1984 SCHERING AG PHARMACIA AND UPJOHN SUB PFIZER INC HOECHST CELANESE CORP HUNTINGTON LABS INC VIS FARMACEUTICA SILGAN PLASTICS CORP NATIONAL CAN CORP MALLINCKRODT INC I II I 3/26/1984 3/19/1984 I I II II II 3/2/1984 4/11/1984 2/27/1984 ISOCHEM SA KYOWA HAKKO KOGYO CO LTD SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT ROCHE DIAGNOSTICS GMBH DIOSYNTH BV I I I II II II I 2/16/1984 2/13/1984 3/19/1984 3/20/1984 STATUS Type SUBMIT DATE II 2/29/1984 HOLDER BEECHAM LABORATORIES DIV BEECHAM INC ORION CORP FERMION EGIS PHARMACEUTICALS HEINRICH MACK NACHF MAPRIMED SA SUBJECT

4Q2012

STERILE AMOXICILLIN SODIUM AS MFG IN THE PISCATAWAY, NEW JERSEY PLANT TRIOXSALEN, USP XX AS MANUFACTURED IN THE MANKKAA PLANT TAMOXIFEN CITRATE MFG BY EGYT & TRADED BY MEDIMPEX HUNGARIAN TRADING C CYTARABINE AS MANUFACTURED IN THE ILLERTISSEN FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MORGUIONDO 2011, ARGENTINA MANUFACTURING PROCEDURES FOR ETINTIDINE HYDROCHLORIDE ACEGLUTAMIDE ALUMINUM GRANULES (KW-110) MFG IN THE FUJI PLANT TDM-85-530 B AS MANUFACTURED IN THE BASLE, SWITZERLAND FACILITIES METHYLDOPATE HYDROCHLORIDE AS MANUFACTURED IN THE MANNHEIM FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN OSS, HOLLAND. HYDROXYPROGESTERONE CAPROATE AS MANUFACTURED IN THE BERLIN FACILITIES DINOPROST TROMETHAMINE AS MANUFACTURED IN KALAMAZOO, MICH. TOLBUTAMIDE USP, BULK FORM AS MFG IN THE COVENTRY, R.I. FACILITIES POVIDONE IODINE AS PRODUCED IN THE HUNTINGTON, INDIANA FACILITIES IMIPRAMINE PAMOATE AS MANUFACTURED IN THE PADOVA FACILITIES PET BOTTLES MANUFACTURED IN THE US AND CANADA PLASTIC CAPS AS MFG IN THE BEDFORD PARK, ILLINOIS FACILITIES ACETAMINOPHEN USP (ESUB) AS MANUFACTURED IN RALEIGH, NORTH CAROLINA. PLANT METAPROTERENOL SULFATE AS MANUFACTURED IN THE LOMAGNA (COMO) FACILITY DEXCHLORPHENIRAMINE MALEATE AS MANUFACTURED IN ROZZANO (MILANO) PLANT 6-MERCAPTOPURINE HYDRATE AS OBTAINED FROM PHARMA-WALDHOF GMBH HEXURONYL HEXOSAMINOGLYCAN SULFATE MFG IN THE FRANKLIN,OHIO FACILITIES RUBBER CLOSURES AS MANUFACTURED IN THE NARA, JAPAN FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN EUGENIO GARZON, BUENOS AIRES. CADEXOMER IODINE VINBLASTIN SULFATE AS MANUFACTURED IN THE LOUVAIN-LA-NEUVE FACILITIES SOP USED IN PRODUCTION OF SPECIFIC DRUG SUBSTANCES IN KANAGAWA PLANT ACEGLUTAMIDE ALUMINUM AS MANUFACTURED IN THE SAKAI PLANT' GONADORELIN ACETATE CHLORZOXAZONE AS MANUFACTURED IN THE BRONX, NEW YORK FACILITIES B ETHIOCHOLANOLONE(3 B-HYDROXY-5B-ANDROSTAN-17-ONE)MFG CULVER,INDIANA NUOPLAZ 6959 HIGH PURITY PLASTICIZER AS MFG CHESTERTOWN, MARYLAND MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BIRSFELDEN.

UNIQUE PHARMACEUTICAL LABORATORIES PROPRANOLOL HYDROCHLORIDE (U.S.P.)

UNIQUE PHARMACEUTICAL LABORATORIES DILOXANIDE FUROATE (B.P.)MFG IN THE ANKLESHWAR, GUIJARA FACILITIES

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4Q2012EXCEL DMF# 5343 5344 I 5345 I 5346 I 5347 5348 5349 A 5350 5351 5352 I 5353 I 5354 5355 5356 5357 5358 I 5359 5360 A 5361 5362 I 5363 5364 5365 I 5366 5367 5368 I 5369 I 5370 5371 5372 5373 I I I I II I II I 3/28/1984 4/23/1984 4/30/1984 5/24/1984 SCHERING AG SYNTEX USA INC NEWPORT PHARMACEUTICALS (IRELAND) PRIVATE FORMULATIONS INC I 5/14/1984 LEIRAS PHARMACEUTICALS I I I II I 4/30/1984 4/20/1984 5/4/1984 BIO-RESPONSE, INC. FARCHEMIA POLYPLASTICS INC FACILITY IN HAYWARD, CALIFORNIA (TRANS TO BIOLOGICS 7/18/86) I I II II II 4/18/1984 4/27/1984 5/14/1984 FERMION OY A NATTERMANN AND CIE GMBH NITA PHARMACEUTICAL LTD I III I 5/29/1984 5/11/1984 NOVEON INC GUARDIAN PACKAGING I II III 4/18/1984 4/30/1984 I I I I II II II II I 3/28/1984 4/11/1984 5/3/1984 4/17/1984 4/25/1984 HEXAGON LABORATORIES INC SANOFI WINTHROP INC NIHON NOHYAKU CO LTD KV PHARMACEUTICAL CO II 4/30/1984 I I III II I 5/10/1984 5/17/1984 5/11/1984 I I II II III 5/3/1984 3/14/1984 4/11/1984 II 5/3/1984 LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO DAIICHI SEIYAKU CO LTD HEXAGON LABORATORIES INC ALCAN PACKAGING TSCHEULIN ROTHAL GMBH BASF AKTIENGESELLSCHAFT ORGANICHEM CORP SOCIEDAD MEXICANA DE QUIMICA INDUSTRIAL SA NITA PHARMACEUTICAL LTD I 5/3/1984 AB ASTRA STATUS Type SUBMIT DATE I II I 4/11/1984 5/1/1984 HOLDER SATO YAKUHIN KOGYO COMPANY LTD INDENA INDUSTRIA DERIVATI NATURALI SUBJECT ACEGLUTAMIDE GRANULES (BULK) AS MANUFACTURED IN THE NARA PLANT

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SETTALA PLANT. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SODERTALJE. ETODOLAC (ETODOLIC ACID) AS MFG IN THE BOUND BROOK,NEW JERSEY FACILITY MALOTILATE 200 MG TABLETS AS MANUFACTURED IN THE SHIZUOKA FACILITY PYRILAMINE MALEATE AS MANUFACTURED IN THE BRONX, NEW YORK FACILITIES LAMINATED DRUG PACKAGING PRODUCTS NOVOLEN POLYPROPYLENE PRODUCTS: 1. NOVOLEN 1400 MX TRIETHYLENETETRAMINE DIHYDROCHLORIDE (TRIENE) MFG ROCHESTER, N.Y. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SANTA CLARA, EDO DE MEXICO. TRIAMCINOLONE AND RELATED PRODUCTS MFG FREEPORT, GRAND BAHAMA FACILITY DEXBROMPHENIRAMINE MALEATE USP XX MFG IN THE BRONX, N.Y. FACILITIES DIARIZOATE SODIUM USP MFGDUDLEY NEAR CRAMLINGTON, NORTHUMBERLAND. MALOTILATE AS MANUFACTURED IN THE IBARAKI AND KASHIMA PLANT ORABASE HYDROCORTISONE ACETATE 0.5% ORAL PASTE MFG ST. LOUIS, MO.

ABBOTT LABORATORIES PHARMACEUTICAL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PRODUCTS DIV PROCEDURES IN NORTH CHICAGO, ILLINOIS. FARMITALIA CARLO ERBA EPIRUBICIN HYDROCHLORIDE AS MANUFACTURED IN THE RODANO (MI) FACILITY 3M DRUG DELIVERY SYSTEMS CONTAINER-CLOSURE SYSTEM FOR CFC INHALATION AEROSOLS MANUFACTURED IN NORTHRIDGE, CA ESTANE 5714 MANUFACTURED IN THE AVON LAKE, OHIO FACILITY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LANSDALE, PENNSYLVANIA. TAMOXIFEN CITRATE AS MANUFACTURED IN OULU, FINLAND. HALOPERIDOL AS MANUFACTURED IN THE APPENWEIER FACILITY FLUOCINOLONE 16,17 ACETONIDE & FLUOCINOLONE MFG FREEPORT,GRAND BAHAMAS

DESIPRAMINE HYDROCHLORIDE USP MFG IN THE TREVIGLIO (BERGAMO) PLANT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HUMACAO. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TURKU, FINLAND. BOLDENONE UNDECYLENATE AS MANUFACTURED IN THE BERLIN PLANT FOR THE SYNTEX AGRIBUSINESS FACILITY IN SPRINGFIELD, MO. ISOPRINOSINE (INOSIPLEX) BULK FORM (MFG BALDOYLE, DUBLIN FACILITY) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN EDISON, NEW JERSEY.

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4Q2012EXCEL DMF# 5374 I 5375 I 5376 I 5377 5378 5379 5380 5381 5382 I 5383 5384 A 5385 5386 5387 I 5388 5389 5390 5391 I 5392 I 5393 5394 I 5395 5396 5397 5398 5399 A 5400 I 5401 5402 5403 I 5404 A II 4/10/1984 DIPHARMA FRANCIS SRL I I II II I 6/18/1984 5/17/1984 3/19/1984 V 5/21/1984 I I I I II II II III II 5/31/1984 6/12/1984 5/21/1984 2/20/1984 5/22/1984 EISAI CO LTD SUMIKA FINE CHEMICALS CO LTD GANES CHEMICALS INC GEORGIA GULF CORP I II I 5/31/1984 5/24/1984 AINC BACHEM FINE CHEMICALS INC II 5/21/1984 YONEZAWA HAMARI CHEMICALS LTD I A A II II II I 5/17/1984 5/11/1984 6/6/1984 4/17/1984 I I I II I 6/8/1984 5/3/1984 5/24/1984 ELAN PHARM RES CORP SANDOZ PHARM CORP I II II 6/1/1984 6/6/1984 UPJOHN CO KATWIJK CHEMIE BV I I I I A IV II II II II I 5/29/1984 2/9/1984 6/1/1984 5/11/1984 6/1/1984 5/22/1984 II 5/24/1984 I 5/17/1984 STATUS Type SUBMIT DATE II 5/23/1984 HOLDER SUBJECT

4Q2012

ABBOTT LABORATORIES PHARMACEUTICAL METHOCARBAMOL AS MFG IN THE NORTH CHICAGO, ILLINOIS FACILITIES PRODUCTS DIV FRESENIUS USA INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CANTON, MASSACHUSETTS. BOEHRINGER INGELHEIM PHARMA GMBH YOHIMBINE HYDROCHLORIDE AS PROCESSED IN THE INGELHEIM PLANT AND CO KG DAVID MICHAEL & COMPANY INC FLAVORING FORMULATION (PRODUCED IN PHIL. PA) 1. ARTIFIC. GRAPE # 7201 SIGMA F AND D DIV LTD PFANSTIEHL LABORATORIES INC ORION CORP FARMOS CHEMICAL PLANT ALBEMARLE CORP FABBRICA ITALIANI SINTETICI SPA D-AMPHETAMINE SULFATE # A5880 FD & (+) METHAMPHETAMINE HCL NO. M8750FD 9-BETA-D-ARABINOFURANOSYL ADENINE MFG WAUKEGAN, ILLINOIS FACILITIES DETOMIDINE HYDROCHLORIDE AS MANUFACTURED IN THE OULU PLANT IBUPROFEN AS MANUFACTURED IN THE ORANGEBURG, SOUTH CAROLINA FACILITY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ALTE DI MONTECCHIO MAGGIORE. ETODOLAC MICRONIZED AS PROCESSED IN THE KALAMAZOO, MICHIGAN FACILITY PHENYTOIN/PHENYTOIN SODIUM MANUFACTURED IN KATIJK AAN ZEE, THE NETHERLANDS. QUALITY CONTROL LABORATORY AND PRODUCTION FACILITIES, GAINESVILLE, GA. CHLORPHENIRAMINE MALEATE MFG IN THE EAST HANOVER, NEW JERSEY FACILITY

AYERST LABORATORIES INC DIV AMERICAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING HOME PRODUCTS CORP PROCEDURES IN ROUSES POINT, NEW YORK. YONEZAWA HAMARI CHEMICALS LTD L-CARNITINE AS MANUFACTUREED IN THE YONEZAWA, YAMAGATA PLANT BAYER SCHERING PHARMA AG KATWIJK CHEMIE BV XACTDOSE INC MEDROXYPROGESTERONE ACETATE MANUFACTURED IN BERLIN, GERMANY. SULFACETAMIDE/SULFACETAMIDE SODIUM AS MFG KATWIJK AAN ZEE FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ROSCOE, ILLINOIS. IBUPROFEN MFG BY YONEZAWA HAMARI CHEM LTD (YONEZAWA, YAMAGATA PLANT) AQAE-CELLULOSE-1 ION EXCHG.MEDIA(STAFFORD SPRINGS & TALCOTTVILLE,CT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES FOR THE TORRANCE, CALIFORNIA PLANT ON KASHIWA STREET. BENTIROMIDE AS MFG IN THE KAWASHIMA PLANT, GIFU-KEN LOCATION THIOTEPA USP XX AS MFG IN THE GIFU PLANT BUSPIRONE HYDROCHLORIDE MFG AND SOLD UNDER THE SIEGFRIED LABEL PROCEDURES & FORMULAS FOR MFGR OF POLYVINYL CHL CMPDS-IN GALLMAN, MISS

UNION QUIMICO FARMACEUTICA SA UQUIFA DOXYLAMINE SUCCINATE USP MFG BY MALLINCKRODT DIEBURG IN GERMANY SA AMERICAN PHARMACEUTICAL PARTNERS, STERILE PROCESSING OF GLASS VIALS IN GRAND ISLAND, NY INC. BAYER NITRENDIPINE, RAW MATERIAL SUB.(TM:BAYPRESS)--MFG WUPPERTAL FACILITIES JANSSEN PHARMACEUTICA NV MERCK KGAA DOMPERIDONE (RESEARCH CODE R-33812) AS MFG IN THE BELGIUM FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ALCALA, SPAIN. DOXEPIN HCL MFG IN THE MILANO FACILITIES (VIA G.B. GRASSI, 97)

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4Q2012EXCEL DMF# 5405 I 5406 A 5407 I 5408 5409 5410 5411 5412 5413 5414 5415 5416 5417 5418 5419 I 5420 I 5421 5422 I 5423 A 5424 5425 5426 5427 5428 I 5429 I 5430 5431 I 5432 5433 I 5434 5435 5436 5437 I A I I III II II II 5/29/1984 6/28/1984 6/25/1984 6/22/1984 ARMOUR PHARMACEUTICAL CO ROCHE DIAGNOSTICS GMBH KYOWA HAKKO USA INC LONZA INC I II I 6/14/1984 6/12/1984 JANSSEN PHARMACEUTICA NV ANDERSEN LABORATORIES INC I II II 7/3/1984 5/21/1984 AAI PHARMA LLC NITA PHARMACEUTICAL LTD II 7/9/1984 I I I I II II I II I 6/20/1984 1/26/1984 7/5/1984 7/9/1984 6/29/1984 II 5/1/1984 I II II 3/2/1984 6/25/1984 MTM CHEMICALS INC LABORATORIO CHIMICO INTERNATIONAL SPA CHINA NATIONAL CHEMICAL IMPORT AND EXPORT CORP ELI LILLY INDUSTRIES INC NV ORGANON MOLDCRAFT DIV ANCHOR HOCKING CORP LUSOCHIMICA S P A KRKA PHARMACEUTICAL & CHEMICAL WORKS MONSANTO COMPANY II 5/22/1984 DINAMITE DIPHARMA SPA A I I I A I A I A I I II II II II II II V II II II II I 3/19/1984 5/23/1984 4/4/1984 5/31/1984 2/7/1984 5/9/1984 6/18/1984 6/12/1984 6/8/1984 6/20/1984 6/21/1984 5/25/1984 II 4/20/1984 III 2/20/1984 STATUS Type SUBMIT DATE II 5/25/1984 HOLDER LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO GEORGIA GULF CHEMICALS AND VINYLS LLC INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA FERMION OY BRACCO IND CHIMICA SPA PARKE DAVIS DIV WARNER LAMBERT CO BAYER INALCO SPA BIOGAL PHARMACEUTICAL WORKS SERONO INC DM GRAHAM LABORATORIES INC PROQUINA SA ELI LILLY INDUSTRIES INC ROUSSEL-UCLAF JANSSEN PHARMACEUTICA NV SUBJECT

4Q2012

7-ETHYLTRYPTOPHOL (INTERMEDIATE FOR ETODOLAC)MFG BY AMERICAN CYANAMID POLYVINYL CPDS-MFGR/PROCEEDS/FORMULAS--TIPTONVILLE,TN CLOFIBRATE USP AS MFG IN THE CARONNO PERTUSELLA (VARESE) FACILITIES AZATHIOPRINE AS MFG. IN ESPOO, FINLAND IOPANOIC ACID USP AS MFG IN THE MILANO FACILITIES 8-ARGININE VASOPRESSIN (8-AVP) MFG PARKE-DAVIS FAC (HOLLAND, MICHIGAN) MYCOSPOR (BIFONAZOLE) CREAM 1% MANUFACTURED IN WUPPERTAL. LACTULOSE 50% SYRUP AS MFG IN PISTOIA (ITALY) BY INFRA S.R.L. PENICILLAMINE AS MFG IN THE DEBRECEN (HUNGARY) FACILITIES BIOEQUIVALANCE STUDY ON THREE CLOMIPHENE CITRATE PRODUCTS AEROLATE CONTROLLED-RELEASE CAPSULES CONTAINING THEOPHYLLINE PROGESTERONE MFG IN THE IXTACZOQUITLAN, VER FACILITY IN MEXICO ACETOHEXAMIDE BULK FORM MFG IN THE TIPPECANOE LABS, LAFAYETTE, INDIANA CIRAMADOL HYDROCHLORIDE MFGIN THE VERTOLAYE (FRANCE) FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN PHARMACEUTICAL PRODUCTION UNIT, BEERSE, BELGIUM. VERAPAMIL HCL MANUFACTURED IN THE BARANZATE DI BOLLATE (MILAN), ITALY FACILITIES AZONE PHARM AS MFG IN THE COLUMBUS, OHIO FACILITIES ON ALAS STREET THIORIDAZINE HCL USP AS MFGR IN THE SEGRATE, MILAN, ITALY FACILITY GUAIFENESIN USP MFG BY XIN XIN & SOLD BY CHINA NATIONAL ACETOHEXAMIDE BULK FORM MFG BY ELI LILLY IND. INC.MAYAGUEZ,PUERTO RICO PROCHLORPERAZINE EDISYLATE MFG. IN THE OSS FACILITY AT KLOOSTERSTRAAT6 FAC. & PROCEDURES FOR INJECTION MOLDING,CLOSURES & CLOSURE COMPONENTS TOLNAFTATE USP XX AS MFG IN THE MILANO, ITALY FACILITIES FOR THE NOVO MESTO PLANT LEUCOVORIN CALCIUM, BULK MFG DAYTON,OHIO BY DAYTON LABS OF MONSANTO CO PROPOXYPHENE HCL BULK & INTERMEDIATE PRODUCED BY TIPPECANOE LABS BETAMETHASONE AND BETAMETHASONE SALTS MFG FREEPORT, GRAND BAHAMA FAC. OXATOMIDE TABLETS 30 MG AS MFG. IN THE BEERSE, BELGIUM PHARM. PLANT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NORWICH, NEW YORK. FORM/FILL/SEAL PROCESSING IMPLEMENTED IN THE KANKAKEE, ILL. FACILITIES METAXALONE MFG IN MANNHEIM, GERMANY AMINOETHYLSULFONIC ACID (TAURINE) MFG IN THE OHMIYA FACTORY ETODOLAC INTERMEDIATES AS MFG INVISP, SWITZERLAND PLANT

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4Q2012EXCEL DMF# 5438 5439 5440 5441 A 5442 I 5443 5444 5445 A 5446 5447 5448 5449 5450 5451 I 5452 I 5453 5454 5455 I 5456 5457 5458 5459 I 5460 I 5461 5462 5463 I 5464 I 5465 I 5466 5467 I 5468 5469 I I II II 7/20/1984 8/1/1984 SANKYO CO LTD OMNICHEM NV (PRB) NIMUSTINE HCL (NIDRAN) IN VIALS MFG IN THE HIRASUKA PLANT I II II 6/27/1984 7/18/1984 II 7/20/1984 II 7/19/1984 LABORATOIRES D'ETUDES ET DE RECHERCHES SYNTHELABO COMPANIA ESPANOLA DE SINTESIS QUIMICA SA ALFRED BENZON AS AVECIA INC I I II II II 7/20/1984 7/17/1984 7/20/1984 SANKYO CO LTD GEDEON RICHTER BIOTEK INC II 7/18/1984 AVECIA INC. I A I II IV IV I 7/18/1984 6/22/1984 6/29/1984 6/27/1984 I I II II II 2/20/1984 6/25/1984 6/26/1984 II 7/2/1984 SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT WHITMOYER LABS INC ORION CORP LTD I I I I I II III II II II I 6/4/1984 7/17/1984 2/8/1984 6/25/1984 6/25/1984 6/26/1984 CIPLA LTD BETHAM CORP ROQUETTE FRERES GEDEON RICHTER KNOLL PHARMACEUTICAL CO MOEHS SA DIV OF SANOF I I II II III 6/29/1984 10/7/1983 6/28/1984 ROQUETTE FRERES SIGMA F AND D DIV LTD AMCOR FLEXIBLES KREUZLINGEN AG I 5/21/1984 STATUS Type SUBMIT DATE I I A II II II II 5/1/1984 6/29/1984 6/29/1984 5/24/1984 HOLDER CIPLA LTD SANOFI PHARMACEUTICALS INC GENERAL CHEMICAL LLC BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG ARZNEIMITTEL GMBH SUBJECT

4Q2012

IBUPROFEN USP AS PROCESSED IN FACTORIES NO.2, NO. 3, NO.4 CITED IN DMF MEPHENTERMINE (BASE & SULFATE) MFG DUDLEY NEAR CRAMLINGTON & FAWDON. POTASSIUM CHLORIDE MANUFACTURED IN MIDLOTHIAN, TEXAS. PRODUCTION PROCEDURE:HOMATROPINE METHYLBROMIDE(INGELHEIM AM RHEIN PLT) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RAVENSBURG. MANNITOL AS MFG IN THE LESTREM, FRANCE FACILITIES HYDRAZINE SULFATE (FAIRMOUNT CHEMICAL) ALUMINUM FOIL (BLISTER PACKAGING),MANUFACTURED IN KREUZLINGEN, SWITZERLAND CLONIDINE HCL MFG IN THE VIKHROLI, BOMBAY FACILITY PRESSURE SENSITIVE ADHESIVES MFG.MIDDLESEX,N.J.FACIL:1.PRODUCT X1266-A SODIUM STARCH GLYOLATE LOW PH MFG IN THE LESTREM, FRANCE FACILITIES FLUMECINOL MFG BY GEDEON RICHTER LTD & TRADED BY MEDIMPEX (HUNGARY) BTS 49 465 MFG IN THE BEESTON, NOTTINGHAM (ENGLAND) FACILITY MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN RUBI, BARCELONA(SPAIN) PLANT BOPINDOLOL MFG IN THE BASLE, SWITZERLAND FACILITIES CHLORHEXIDINE (BASE, DIHYDROCHLORIDE, GLUCONATE AND DIACETATE) SUCRALFATE AS MANUFACTURED IN THE HANKO, FINLAND PLANT

TEMMLER WERKE VEREINIGTE CHEMISCHE KETOPROFEN S.R. CAPSULES MFG IN THE MARBURG, GERMANY FACILITY FABRIKEN SCHERING AG DIFLUCORTOLONE-21-VALERATE MFG IN THE WEDDING PLANT (BERLIN) FMC CORP FMC BIOPOLYMER DIV GATTEFOSSE ESTABLISSEMENTS ORGANICHEM CORP AQUATERIC CD-910 AQUEOUS ENTERIC COATING MFG NEWARK, DELAWARE FAC. GELUCIRE 46/07; 48/09; AND 53/10 AS MFGR IN SAINT-PRIEST FRANCE FACILS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HVIDOVRE AND COPENHAGEN, DENMARK. SDM-25 (25/75 ISOSORBIDE DINITRATE-MANNITOL MIXTURE)MANUFACTURED IN TAMAQUA, PA. BULK FORM OF NIMUSTINE HCL (NIDRAN) MFG IN THE SHINAGAWA PLANT, SANKYO KETAMINE HCL-MFG GEDEON RICHTER & MEDIMPEX HUNGARIAN TRADING CO. VAGINAL CONTRACEPTIVE SUPPOSITORIES MFG WOBURN, MASSACHUSETTS FACILITY BETAXOLOL HYDROCHLORIDE-MFG. IN PORCHEVILLE, ANALYZED IN ANTONY(FRANCE BETAMETHASONE VALERATE USP XX ACETARD(ACETYSALICYLIC ACID)C.R. TABS(3 DOSAGE FORMS) MFG IN DENMARK SDM-47 (10/90 NITROGLYCERIN-PLASTISOL MIXTURE) MANUFACTURED IN TAMAQUA, PA..

CIRAMADOL HYDROCHLORIDE AS MANUFACTURED IN THE WETTEREN FACILITIES

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4Q2012EXCEL DMF# 5470 I 5471 5472 5473 I 5474 I 5475 I 5476 5477 5478 I 5479 5480 I 5481 5482 5483 5484 5485 5486 5487 5488 A 5489 5490 I 5491 5492 5493 I 5494 A 5495 5496 5497 5498 5499 5500 5501 5502 I I A A I A I I IV II II II II II II II 4/18/1984 8/10/1984 7/30/1984 6/11/1984 7/30/1984 8/15/1984 7/24/1984 8/1/1984 II 1/11/1984 I I II II II 7/31/1984 6/12/1984 4/18/1984 LABORATOR MAG VIA MILANO UPJOHN CO INDUSTRIAL PHARMACEUTICAL SERVICE LTD BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG AE STALEY CO ORTHO PHARMA PRIVATE LTD FARCHEMIA SRL PHARMACIA AND UPJOHN AMERICAN CHEMICAL INDUSTRIAL CORP TEVA PHARMACEUTICALS INDUSTRIES LTD SUMIKA FINE CHEMICALS CO LTD REGIS CHEM CO I II I 7/20/1984 7/12/1984 SIFAVITOR SPA NOVOPHARM LTD CLOTRIMAZOLE USP XX AS MFG IN THE TRIBIANO (MILANO) ITALY PLANT FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES FOR THE SCARBOROUGH, ONTARIO CANADA PLANT. NYLIDRIN HCL AS MFG IN THE GARBAGNAE MILANESE FACTORY I I I I I I I II II II II II II II III 7/20/1984 8/11/1984 7/20/1984 8/1/1984 7/25/1984 7/17/1984 6/13/1984 7/27/1984 I III II 5/22/1984 4/24/1984 PRECISE TECHNOLOGY INC AMERSHAM INTERNATIONAL PLC AMERSHAM LABORATORY DIAMALT AG PROSINTEX SPA HOECHST CELANESE CORP SANOFI SA ZAMBON SPA FINE CHEMICALS CORPORATION UPJOHN CO HOSPIRA INC I I II II II 7/5/1984 7/24/1984 7/19/1984 NITA PHARMACEUTICAL LTD AAI PHARMA LLC DINAMITE DIPHARMA SPA I 7/20/1984 DIAMALT AG I 8/8/1984 EURAND AMERICA INC I I IV II I 8/8/1984 3/30/1984 7/25/1984 GATTEFOSSE ESTABLISSEMENTS AMERSHAM RADIOCHEMICAL CENTER WEST CO STATUS Type SUBMIT DATE I 8/1/1984 HOLDER MCNEIL PHARMACEUTICAL LTD SUBJECT

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN STOUFFVILLE, ONTARIO, CANADA. GELUCIRE 35/10 & GELUCIRE 42/12 MANUFACTURED IN SAINT-PRIEST, FRANCE. 111 INDIUM CHL RADIOCHEM SOLUTION MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WEST CO, MED PLASTICS DIV, JERSEY SHORE, PA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DAYTON, OHIO. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF PEPTIDES IN MUNICH, GERMANY. DESONIDE (PREDNACINOLONE 16,17 ACETONIDE)MFG FREEPORT, GRAND BAHAMA PROPOXYPHENE NAPSYLATE PRODUCED BY TIPPECANOE LABS IN LAFAYETTE, IN. NAPROXEN SODIUM MANUFACTURED IN THE BARANZAE DI BOLLATE (MILAN), ITALY FACILITIES PACKAGING MATERIAL 89 STRONTIUM CHL. RADIOCHEM SOLUTION-PROCESSED IN BUCKINGHAMSHIRE,ENG. SOMATOSTATIN AS MANUFACTURED IN THE MUNICH PLANT TRIFLUOPERAZINE HCL MFG IN THE VILLANTERIO (PAVIA) ITALY FACILITIES CHLORPROPAMIDE USP AS MFG IN THE COVENTRY, RHODE ISLAND FACILITIES NALMEFENE HYDROCHLORIDE MFG BY SEMPA-CHIMIE IN ARAMON, FRANCE IBUPROFEN USP XX AS MFG IN THE ALMISANO DI LONIGO (VICENZA) PLANT MEDROXYPROGESTERONE ACETATE MFG IN THE CAPE PROVINCE FACILITIES CORTISONE ACETATE USP, MICRO & NON MICRO MFG KALAMAZOO, MICHIGAN FAC. PLASTIC SHROUD FOR ADD-VANTAGE VIAL MFG BUFFALO NY AND ASHLAND, OH FAC

PREDNISONE ACETATE, MICRO & NON-MICRO MFG KALAMAZOO, MICHIGAN FAC. HYDROFLUORIC ACID BURN JELLY MFG CROWN CHEM CO FOR IND PHARM SER LTD ATROPINE SULFATE AS PRODUCED IN THE INGELHEIM FACILITIES PURIFIED SOYBEAN OIL AS PROCESSED IN THE DECATUR, ILLINOIS FACILITIES CHLORPROPAMIDE AS MFG IN THE KALYANI, WEST BENGAL FACILITY CIMETIDINE MANUFACTURED IN TREVIGLIO (BERGAMO), ITALY. HYDROCORTISONE ACETATE USP,MICRO & NON-MICRO CHLORPROMAZINE HCL USP(BULK) MFG RICHMOND,CA (FORMERLY BENZYL PROD INC TAMOXIFEN CITRATE USP AS MFG IN THE NETANYA, ISRAEL FACILITIES NIFEDIPINE USP XX AS MFG IN THE GIFU PLANT CLORGYLINE (REGIS CODE NO. 002061) AS MFG IN MORTON GROVE,ILLINOIS FAC

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4Q2012EXCEL DMF# 5503 I 5504 5505 A 5506 5507 I 5508 I 5509 5510 5511 5512 I 5513 I 5514 5515 A 5516 5517 5518 5519 5520 I 5521 5522 5523 5524 5525 5526 5527 5528 5529 5530 I 5531 5532 5533 5534 I 5535 I II 9/19/1984 DYNAMIT NOBEL AKTIENGESELLESCHAFT A I I II III II II 7/23/1984 9/20/1984 9/14/1984 9/18/1984 BROOKHAVEN NATIONAL LABORATORY INNOVATION TECHNOLOGY INC NOVO NORDISK AS MITSUBISHI CORP I I I A I I I I I II II V III II II II II II II 8/16/1984 8/30/1984 9/12/1984 7/12/1984 8/29/1984 9/17/1984 9/14/1984 9/13/1984 9/13/1984 9/21/1984 BIOCHEMIC GESELLSCHAFT MBH MOEHS SA DIV OF SANOF NATL INST HLTH NCI BESPAK DIV CONSORT MEDICAL PLC HAZER CHEMICALS INC KNOLL AG LUDWIGSHAFEN NOVO NORDISK AS ROUSSEL-UCLAF SIGMA F AND D DIV LTD UPSHER SMITH LABS INC I I I I IV II III II I 8/27/1984 8/14/1984 9/6/1984 9/5/1984 6/15/1984 I II II 7/6/1983 7/23/1984 SIGMA F AND D DIV LTD II 9/7/1984 CHEMSPEC CHEMICALS PRIVATE LTD I I I II IV II IV 8/17/1984 9/6/1984 9/7/1984 9/1/1984 KV PHARMACEUTICAL CO BAYER AG GEDEON RICHTER PT GELATINDO MUKTI GRAHA I 8/20/1984 A III II 8/17/1984 7/23/1984 I II II 6/23/1984 7/16/1984 PFIZER INC VALEANT PHARMACEUTICALS NORTH AMERICA HOSPIRA INC SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT PARKE DAVIS DIV WARNER LAMBERT CO STATUS Type SUBMIT DATE I 8/23/1984 HOLDER MEIJI SEIKA KAISHA LTD SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KAWASAKI, KANAGAWA, JAPAN. PREDNISOLONE ACETATE USP,MICRO & NON MICRO PYRIDOSTIGMINE BROMIDE 30 MG TABLETS MFG IN QUEBEC, CANADA MICROBIOLOGICAL VALIDATION OF THE ADD-VANTAGE FLEXIBLE CONTAINER TEMAZEPAM AS MFG. IN BASLE, SWITZERLAND, FACILITY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GWENT, UNITED KINGDOM. UNISOM CAPS(DOXYLAMINE USP)MANUFACTURED IN ST. LOUIS, MISSOURI.

4Q2012

BAYER PRODUCTS IN THE MAKROLON SERIES AS MFG. IN UERDINGEN FACILITY PIPECURONIUM BROMIDE MFG BY GEDEON RICHTER&TRADED BY MEDIMPEX,HUNGARY PROCEDURES & COMPONENTS FOR MFG HARD SHELL EMPTY GEL CAPS (JAWA BARA) HEXACHLOROPHENE MFG IN THE ANAND CHEMICALS COMPOUND POWAI POINT BOMBAY AROPINE METHYL NITRATE AS SUPPLIED BY MAC FARALAN SMITH, LIMITED

LOS ALAMOS NATIONAL LABORATORY DEPT STRONTIUM-82 MANUFACTURED IN LOS ALAMOS, NEW MEXICO. ENERGY MORGAN ADHESIVES CO PRESSURE SENSITIVE ADHESIVE SUBSTRATES MFG MOOSIC PA HOUBA INC GE SILICONES SUTTON LABORATORIES DAVID BULL LABORATORIES PTY LTD DEXBROMPHENIRAMINE MALEATE AS MFG. IN THE CULVER, INDIANA, FACILITIES BAYILONE LIQUID SILICONE RUBBER PRODUCTS MFG LEVERKUSEN: 1. LSR 3174 GERMALL II (DIAZOLIDINYL UREA) AS MFG. CHAHAM, N.J. FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MULGRAVE, AUSTRALIA. D-PENICILLAMINE MFG IN THE KUNDL, TYROL (AUSTRIA) FACILITIES SULFAMETHOXAZOLE USP XX MFG IN RUBI (BARCELONA) FACILITIES MESNA:PRECLINICAL TOXICOLOGY & PHARMACOLOGY STUDIES CONDUCTED FOR NCI BESPAK BK 356 AEROSOL PHAR METERING VALVES MFG KING'S LYNN, NORFOLK SIMETHICONE USP (BULK FORM) MFG IN THE GURNEE, ILLINOIS FACILITIES GALLOPAMIL HCL AS MANUFACTURED IN THE LUDWIGSHAFEN PLANT HUMAN INSULIN (SEMI-SYNTHETIC) AS PROCESSED IN KALUNDBORG & BAGSVATERD DESERPIDINE AS MFG IN THE VERTOLAYE, FRANCE FACILITY HISTOPAQUE (1077 & 1119) & PHYSIOLOGICAL SALTS MIXTURES PROC ST. LOUIS TROFAN (L-TYPTOPHAN)TABLETS & PLACEBO MANUFACTURED IN MINNEAPOLIS, MINNESOTA. STRONTIUM-82 AS PREPARED AT THE BROOKHAVEN NATIONAL LABORATORY COATING FORMULATIONS/HEAT SEAL COATED MATERIALS PKG/LABEL,WARRINGTON HUMAN INSULIN INJ NEUTRAL 500 UNITS/ML PREPARED & PKG BAGSVATERD PLANT L-CIS CIRAMADOL HYDROCHLORIDE(BULK)MFG IN Y.H.CHEM.,YONEZAWA,YAMAGATA NITROGLYCERINE 2.2% IN MIGLYOL(R)812 NEUTRAL AS PROC.IN LEVERKUSEN PLT

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4Q2012EXCEL DMF# 5536 5537 5538 I 5539 5540 I 5541 5542 5543 5544 5545 5546 5547 5548 5549 I 5550 5551 5552 5553 5554 5555 5556 5557 I 5558 I 5559 5560 5561 5562 5563 5564 5565 5566 5567 I 5568 I 5569 I I 10/5/1984 III 9/28/1984 I A I I I I I A II II III II III II III II I 10/4/1984 10/10/1984 9/26/1984 10/11/1984 6/18/1984 10/4/1984 8/30/1984 9/28/1984 10/10/1984 SELOC AG ISOCHEM SAS HELVOET PHARMA ITALIA SPA DIOSYNTH BV HAENDLER AND NATERMANN GMBH SELOC AG BCL LTD ORGAPHARM SAS SUMMA MEDICAL CORP I 9/28/1984 LIPHA SA I A I I I A I II II II II II II III II 9/27/1984 6/27/1984 9/17/1984 10/1/1984 10/11/1984 10/1/1984 6/18/1984 9/26/1984 I A I I I I I I II II II II III II II II II 9/27/1984 9/27/1984 9/12/1984 9/17/1984 8/31/1984 9/20/1984 10/2/1984 9/26/1984 9/20/1984 I II II 10/1/1984 10/12/1984 SCHERING AG DSM PHARMA CHEMICALS SOUTH HAVEN INC BEN VENUE LABORATORIES INC NORDION CANADA INC HOECHST CELANESE CORP EASTMAN KODAK CO HLG, INC DIOSYNTH BV SELOC AG KALI UND SALZ AG YAMAMOTO CHEMICAL INDUSTRIES COMPANY LTD JANSSEN PHARMACEUTICA NV NORDION CANADA INC ORION CORP FARMOS CHEMICAL PLANT SELOC AG DIOSYNTH BV COPPERHEAD INVESTMENTS INC HAENDLER AND NATERMANN GMBH MILES PHARMACEUTICAL DIV MILES INC STATUS Type SUBMIT DATE I I II V IV 9/27/1984 9/25/1984 10/1/1984 HOLDER PENCO OF LYNDHURST INC ROHM AND HAAS CO GATTEFOSSE ESTABLISSEMENTS SUBJECT THEBAINE ALKABOID POWDER MANUFACTURED IN NEWARK, NEW JERSEY.

4Q2012

KAHON CG (KAHON 886):TOXICOLOGICAL INFO. GENERATED TOX.DEPT,R-H CO. GELUCIRE 33/01, GELUCIRE 64/02, OVUCIRE WL 2558, PRECIROL WL 2155, PRECIROL WL 2155 ATO MFG SAINT-PRIEST (LYON) ROLIPRAM AS PRODUCED IN THE BERLIN PLANT SALICYLSALICYLIC ACID AS MFG IN THE SOUTH HAVEN, MICHIGAN FACILITY CYCLOPHOSPHAMIDE LYOPHILIZED FOR INJ(5 DOSAGE FORMS)BEDFORD,OHIO FAC INDIUM-111 AS MANUFACTURED A THE VANCOUVER, B.C. FACILITY CHLORZOXAZONE(BULK)AS MFG. IN THE COVENTRY, RHODE ISLAND, FACILITY RIBAVIRAN;VIREZOLE AS PREPARED IN THE ROCHESTER,NEW YORK FACILITY BLOW-MOLDING PROCEDURES CARRIED OUT IN THE KANSAS CITY,KANSAS FACILITY GLUCAGON MFG BY DIOSYNTH FRANCE IN ERAGNY SUR EPTE (GISORS) FRANCE FUROSEMIDE AS MFG BY SIFA, LTD, A SELOC AFFILIATE IN SHANNON,IRELAND POTASSIUM CHLORIDE USP PRODUCED IN THE HERINGEN (GERMANY) PLANT. ACETAMINOPHEN USP XX AS MANUFACTURED IN THE WAKAYAMA FACILITIES LORCAINIDE HCL (JANSSEN CODE NO.R 15889)MFG IN THE BELGIAN FACILITIES PROCEDURES FOR THE PRODUCTION OF STRONTIUM-82 VANCOUVER, B.C. FACILITY IBUPROFEN,200 MG TABLETS, AS MFG. IN THE TURKU FACILITIES TRIAMTERENE USP XX MFG BY SIFA, LTD(SELOC AFFILIATE IN SHANNON IRELAND BETAMETHASONE VALERATE AS MFG. IN THE OSS FACILITIES,KLOOSTERSTRAA 6 SDM-7 (20/80 NITROGLYCERIN/POLYMER MIXTURE)MANUFACTURED IN TAMAQUA, PA. COMP. & MFG. PROCEDS. DOUBLE LAYER TABS FOIL-PROCESS IN HANN-MUNDEN PL CLOTRIMAZOLE 250 MG ORAL TABLETS MANUFACTUREDIN WEST HAVEN, CONNECTICUT. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PITHIVIERS, FRANCE. PROMAZINE HCL MFG BY SIFA,LTD,(A SELOC AFFILIATE IN IRELAND) INDORAMIN HYDROCHLORIDE PRODUCED IN GENNEVILLIERS FACILITY. CHLOROBUTYL RUBBER COMPOUNDS AS MFG IN THE MILAN FACILITIES. ORF 170 70 MANUFACTURED BY OSS IN KLOOSTERSTRAA 6. COMP & MFG PROC. FOR SINGLE LAYER TAB. FOILS AS PROCES. IN HANN MUNDEN VERAPAMIL HYDROCHLORIDE MFG BY SIFA, LTD A SELCO AFF. IN SHANNON,IREL. COEXTRUDED POLYPROPYLENE FILM MFG BY BCL SHORKO FILMS LTD.IN WIL. ENG. THIOTHIXENE MANUFACTURED IN PITHIVIERS, FRANCE.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ALBUQUERQUE, NEW MEXICO. ABBOTT LABORATORIES PHARMACEUTICAL POLYETHYLENE TEREPHAHALATE PLASTIC VIALS INJECTION MOLDED IN NOR.CHIC. PRODUCTS DIV CONTRACT COATING INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING HACKENSACK, NEW JERSEY FACILITY ON BEECH STREET.

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4Q2012EXCEL DMF# 5570 I 5571 5572 I 5573 5574 5575 I 5576 5577 I 5578 5579 5580 5581 5582 I 5583 5584 5585 5586 5587 I 5588 I 5589 I 5590 5591 A 5592 5593 5594 I 5595 I 5596 5597 I 5598 I 5599 I I 11/19/1984 WINTHROP LABS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. III 11/19/1984 NISSIN CHEMICAL INDUSTRY COMPANY LTD ST-FILM AS MANUFACTURED IN THE TAKEFU PLANT I II II 11/14/1984 11/9/1984 I 10/31/1984 I I II III III 11/1/1984 9/28/1984 10/22/1984 I II III 10/24/1984 11/12/1984 II 10/3/1984 III 10/22/1984 I A I I II II II III I 11/5/1984 11/13/1984 10/23/1984 11/12/1984 11/14/1984 I A I I IV II II II III 10/26/1984 10/22/1984 11/7/1984 10/30/1984 10/22/1984 I III I 8/16/1984 11/5/1984 I I II II III 10/12/1984 11/1/1984 11/2/1984 LAPORTE ORGANICS FRANCIS SPA SYNCOR PHARMACEUTICALS INC DSM MARKETING CENTRE CHEMICALS & POLYMERS ALUMINUM COMPANY OF AMERICA I III I 6/18/1984 9/19/1984 TEICH AG FARMACAPSULAS DE COLUMBIA SA STATUS Type SUBMIT DATE I 9/9/1984 HOLDER TECH PLASTICS INC SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SOUTH MCCLINTOCK DR. TEMPE, ARZ. COATED TABLET FOILS MANUFACTURED IN HANN MUNDEN, GERMANY.

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BARRANQUILLA, COLUMBIA. TOLAZAMIDE USP AS MANUFACTURED IN THE CARONNO PERTUSELLA FACILITY SODIUM IODIDE (1-123) SOLUTION MANUFACTURED IN GOLDEN, COLORADO. LOW DENSITY POLYETHYLENES/BEEK FACIL: STAMYLAN 3400 SERIES & 3400C LAMIN. OF ALUM. FOIL TO POLYESTER FILM & PAPER AS PROC. RIVERDALE IOWA

INTERPHARM PHARMACEUTICAL PRODUCTS BIO-CHEMICL LABS.,INC.,DIV.OF INTERPHARM PHARM PROD INC HAZER CHEMICALS INC BULK PRODUCTION OF SUCROSE POLYESTER IN THE GURNEE, ILLINOIS FACILITY SIEGFRIED LTD PENINSULA LABS DIOSYNTH BV OXICONAZOLE NITRATE MFG AND SOLD UNDER THE SIEGFRIED LABEL D-ALA2, D-LEU5 - ENKEPHALIN AS PROCESSED IN THE BELMONT, CA. FACILITY BETAMETHASONE SODIUM PHOSPHATE IN THE OSS FACIL. ON KLOOSTERSTRA 6

GETTIG PHARMACEUTICAL INSTRUMENT CO RAW MATERIAL SPECIFICATIONS AND TEST PROCEDURES FOR MANUFACTURE OF DIV GETTIG TECHNOLOGIES INC RUBBER COMPONENTS IN KNOX, INDIANA SCHERING AG PREDNISOLONE 21-DISODIUM PHOSPHATE AS MFG.IN BERLIN PLANT MULLERSTRABE ALBEMARLE CORP SIEGFRIED AG LUTZ KG HOFFMANN LA ROCHE INC MECLOFENAMATE SODIUM USP MANUFACTURED IN MICHIGAN. AZAPROPAZONE AS MFG AND SOLD UNDER THE SIEGFRIED LABEL GLASS PHARMACEUTICAL AMPULES MFG IN WERTHHEIM, GERMANY FACILITY

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NUTLEY, NEW JERSEY. GETTIG PHARMACEUTICAL INSTRUMENT CO RUBBER CLOSURE FORM. IN GP 2001 SERIES AS MFG. IN KNOX, IND. FACILITY DIV GETTIG TECHNOLOGIES INC SOCIEDAD MEXICANA DE QUIMICA CHLORPROPAMIDE USP (BULK)-MFG IN THE SANTA CLARA DE JUAREZ FACILITY INDUSTRIAL SA GEDEON RICHTER TOLPERISONE HCL,MFG.IN BUDAPEST PLANT,TRADED-MEDIMPEX HUNGARIAN TR.CO. TOTAL PETROCHEMICALS RESEARCH FELUY SA ACF CHEMIEFARMA NV ROHM AND HAAS CO POLYPROPYLENE RESINS PROCESSED ORTHEZ,FRANCE (LACQTENE P 3020 SM 3) PRECURSOR OF PH 3976 INTERMED. X-MFG IN MAARSSEN (2',5-DIHYDROXY-9,9PRODUCTS IN THE 76-RES SERIES MFG BRIDGEVIEW, ILL. & CHARLOTTE, N.C.

GETTIG PHARMACEUTICAL INSTRUMENT CO RUBBER CLOSURE FORM. IN GP 3001 SERIES, MFG. IN KNOX, IND.FACIL (RED) DIV GETTIG TECHNOLOGIES INC ASTA PHARMA AG MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KONSTANZ PLANT. GANES CHEMICALS INC MEPHOBARBITAL AS MFG IN THE PENNSVILLE, NEW JERSEY FACILITY. EGIS PHARMACEUTICALS PLC CHLORPROMAZINE HCL,MFG.BY EGYT,BUDAPEST,TRADED-MEDIMPEX HUNGARIAN T.CO

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4Q2012EXCEL DMF# 5600 I 5601 I 5602 5603 5604 5605 A 5606 5607 5608 5609 5610 5611 5612 5613 5614 5615 5616 5617 5618 5619 I 5620 I 5621 5622 5623 5624 5625 5626 5627 5628 5629 5630 5631 5632 5633 5634 I 5635 I III 12/11/1984 I I I I I I I I I I I I I IV II I II II II III II II II II II II II 10/26/1984 10/26/1984 11/14/1984 11/23/1984 11/15/1984 11/27/1984 11/20/1984 11/14/1984 12/14/1984 11/21/1984 11/30/1984 12/21/1984 12/12/1984 11/30/1984 GATTEFOSSE ESTABLISSEMENTS DUMEX AS DIV DUMEX LTD SOLOPAK LABORATORIES JANSSEN PHARMACEUTICA NV TAKEDA CHEMICAL INDUSTRIES LTD SUMMA MEDICAL CORP CIBA GEIGY CORP NITTO ELECTRIC INDUSTRIAL CO LTD ASTRA USA INC JANSSEN PHARMACEUTICA NV SUMITOMO CHEMICAL CO LTD HOFFMANN LA ROCHE INC BAYER SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT HOSPIRA INC I 11/14/1984 NITTO ELECTRIC INDUSTRIAL CO LTD MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TOHOKU PLANT IN MIYAGI, JAPAN. TEFOSE 2000 MFG IN THE SAINT-PRIEST FACILITY DISULFARIM AND DISULFARIM HYDROPHILE AS MFG. IN INDONESIA I I I I I I I I I I A A I II II I II II II II II II II II II II II 10/18/1984 11/15/1984 11/19/1984 10/24/1984 12/3/1984 12/10/1984 12/3/1984 11/29/1984 12/11/1984 10/24/1984 10/17/1984 10/26/1984 10/24/1984 11/19/1984 A I I II II II II 11/9/1984 11/9/1984 11/7/1984 11/9/1984 II 10/3/1984 STATUS Type SUBMIT DATE I 10/31/1984 HOLDER ARAB CENTER FOR PHARMACEUTICALS & CHEMICALS SOCIEDAD MEXICANA DE QUIMICA INDUSTRIAL SA BAYER SCHERING PHARMA AG PCAS GEDEON RICHTER LTD SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL MORTON THIOKOL INC NORDIC SYNTHESIS AB WINTHROP LABS TAKEDA CHEMICAL INDUSTRIES LTD SANDOZ PHARMS CORP DIV SANDOZ INC DAIWA PHARMACEUTICAL CO LTD PCAS SUMIKA FINE CHEMICALS CO LTD SMITHKLINE & BECKMAN INC JANSSEN PHARMACEUTICA NV CIPLA LTD MORTON SALT INC TAKEDA CHEMICAL INDUSTRIES LTD KNOLL AG SUBJECT

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF EMPTY HARD GELATIN CAPSULES IN AMMAN, JORDAN. TOLBUTAMIDE USP (BULK) AS MFG IN THE SANTA CLARA DE JUAREZ FACILITY 5-AMINOSALICYLIC ACID, PURE MFG WERK ELBERFELD FACILITY IN WUPPERTAL TRIMEPRAZINE TARTRATE USP MFG BY SIFA,LTD SHANNON(COUNTY CLARE)IRELAND ETHIONAMIDE, MFG. CHEM.WORKS OF G.R.,TRADED,MEDIMPEX HUNGARIAN TR.CO. METOPROLOL TARTRATE MFG IN THE FILARONE REGELLO (FLORENCE) FACILITY N-(2 METHYL-1-NAPHTHYL) MALEIMIDE. ISOSORBIDE-5-MONONITRATE MANUFACTURED IN BOFORS, SWEDEN. FOR STERLING-WINTHROP RESEARCH CENTRE IN ALNWICK BULK PRODUCTION OF OXENDOLONE IN THE HIKARI PLANT BUTALBITAL HYDRALAZINE HYDROCHLORIDE TAMOXIFEN CITRATE MFG BY SIFA,LTD A SELOC AFFILIATE IN SHANNON,IRELAND THIORIDAZINE HCL USP XXI HYDROCHLOROTHIAZIDE CARFENTANIL CITRATE (CODE NO. 33799) MFG BEERSE, BELGIUM FACILITIES DANAZOL USP (ESUB) AS MANUFACTURED IN VIKHRELI,BOMBAY FACTORY POTASSIUM CHLORIDE (USP) MFG BY MORTON SALT DIV IN GRAND SALINE, TEXAS] PROCESSING OF OXENDOLONE AQUOSUSPENSOID INJ IN THE OSAKA PLANT PROCORUM (GALLOPAMIL HCL,50MG)TABS MFG LUDWIGSHAFEN AM RHINE FOR KNOLL

METHODS, FACILITIES & GOP FOR THE FACILITIES,CHICAGO & FRANKLIN PARK RITANSERIN (CODE NO. R 55667 ) SODIUM DEACETYL CEPHALOSPORIN C (DCPE-NA) PRODUCTION IN HIKARI PLANT ANTI-HUMAN CHORIONIC GONADOTROPIN - SUMMATECH-HCG-BETA (ALBUQUERQUE) IRGANOX 1010 USED IN THE MFG. OF PKG. MATERIALS AMIAID ISDN TAPE TOCAINIDE HCL. INJECTION CARFENTANIL INJECTION 3MG./ML. SUMITHRIN HUMAN GROWTH HORMONE RELEASING FACTOR-(1-44)-AMIDE ETOFENAMATE AS MFG IN THE WUPPERTAL FACILITIES LORAZETYL STANDARD MICROBIOLOGICAL METHODS FOR THE FLEXIBLE CANTAINER

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4Q2012EXCEL DMF# 5636 I 5637 5638 5639 5640 5641 I 5642 5643 5644 5645 I 5646 5647 5648 5649 5650 5651 5652 5653 5654 A 5655 I 5656 I 5657 I 5658 I 5659 5660 I 5661 5662 5663 5664 5665 5666 I 5667 5668 I I II II 1/14/1985 1/23/1985 I I I I I II II I II II II 11/6/1984 1/17/1985 1/14/1985 1/12/1985 12/27/1984 1/18/1985 UNICHEM LABORATORIES LTD PENNISULA LABORATORIES INC ALRA LABORATORIES INC MEDICHEM SA ORION CORP LTD FERMION RP SCHERER NORTH AMERICA DIV RP SCHERER CORP OMNICHEM NV (PRB) REGIS CHEM CO I II I 12/18/1984 12/18/1984 ASTA PHARMA AG PACKAGING CORP AMERICA I 1/21/1985 MEDICHEM SA I 1/18/1985 SYLATEC GROUPE SYNTHELABO MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TOURS FRANCE. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CELRA (GERONA) SPAIN. FLUPIRTINE MALEATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PISCATAWAY, N.F. THIACETAZONE GROWTH HORMONE RELEASING FACTOR (HUMAN ) GURNEE,ILL. FACILITY LIDOCAINE BASE $ LIDOCAINE HYDROCHLORIDE CARBAMAZEPINE USP XX CGS-9896 METHOCARBAMOL USP 3,4-DIAMINOPYIDRINE IV 11/5/1984 ROQUETTE FRERES I 1/4/1985 I I A I A I I I III II II II III II II II III 12/20/1984 12/13/1984 12/7/1984 12/17/1984 1/7/1985 1/3/1985 1/4/1985 11/6/1984 10/3/1984 I A I II II II II 12/17/1984 12/20/1984 12/21/1984 12/7/1984 I I I I II II II II II 12/14/1984 11/28/1984 12/17/1984 10/25/1984 12/20/1984 JANSSEN PHARMACEUTICA NV FOREST LABORATORIES INC VELSICOL CHEMICAL CORP HEINRICH MACK NACHF STATUS Type SUBMIT DATE I 10/26/1984 HOLDER SCHERING AG SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. ALTANSERIN TARTRATE (CODE NO. R 53200) MFG IN THE BELGIUM FACILITIES

4Q2012

THIORIDAZINE HCL 200 MG C.R. TABS (IN SYNCHRON VEHICLE)MFG INWOOD N.Y. HEXACHLOROPHENE AS MANUFACTURED IN THE BEAUMONT, TEXAS FACILITY ALEXAN AMPOULES

ABBOTT LABORATORIES PHARMACEUTICAL DICUMAROL PRODUCTS DIV NV ORGANON NALMEFENE HYDROCHLORIDE SIEGFRIED LTD AINC SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT CELANESE SPECIALTY RESINS ORION CORP LTD FERMION FINE CHEMICALS CORP PTY LTD NV ORGANON ADHESIVES RESEARCH INC ALDRICH CHEMICAL COMPANY INC SIGMA F AND D DIV LTD UNICHEM LABORATORIES LTD BASELL POLYOLEFINE ITALIA SRL LYONDELLBASELL INDUSTRIES CO JOHNSON MATTHEY PLC MEPHOBARBITAL AFM SP-CELLULOSE-1 ION-EXCHANGE MEDIA BUTALBITAL CAN END COATING (X-1174CL CLEAR EPOXY) CHLORHEXIDINE BASE AS MFGR IN THE NANKKAA AND HANKO PLANTS FLUPHENAZINE HYDROCHLORIDE AS MFG. IN THE EPPING FACILITY EDROPHONIUM CHLORIDE MEDICAL GRADE ADHESIVES 9-AMINO-1,2,3,4,-TETRAHYDROCRIDINE HCL. (THA) COUMARIN DIPHENHYDRAMINE HYDROCHLORIDE HOSTALEN PACKAGING PRODS: HOSTALEN G & HOSTALEN PP MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WEST DEPTFORD, NEW JERSEY. LYCASIN BRAND HYDROGENATED GLUCOSE SYRUP(LYCASIN HGS)MFG IN LESTREM,FR

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4Q2012EXCEL DMF# 5669 5670 5671 5672 5673 5674 5675 5676 5677 5678 5679 5680 5681 I 5682 I 5683 I 5684 5685 I 5686 5687 5688 5689 5690 I 5691 I 5692 5693 5694 5695 5696 5697 5698 I 5699 I 5700 5701 I 5702 I II 2/14/1985 I III II 2/11/1985 2/13/1985 II 1/18/1985 ORCHIMIE SA (PRODUITS CHIMIQUES ET BIOCHIMIQUES) MONSANTO POLYMER PRODUCTS CO BEECHAM LABORATORIES DIV BEECHAM INC FOREST LABORATORIES INC I A I I I I II II II III III II I 1/28/1985 1/24/1985 11/20/1984 1/30/1985 2/4/1985 2/7/1985 1/30/1985 FINE ORGANICS LTD CAMBREX KARLSKOGA AB INNOPHOS INC TITAN PLASTICS MOBAY CHEMICAL CORP ALDRICH CHEMICAL COMPANY INC BALL UNIMARK PLASTICS DIV BALL CORP I 2/11/1985 PACO PACKAGING INC I I I I II II IV II I 2/7/1985 2/5/1985 11/20/1984 1/25/1985 2/11/1985 ROUSSEL-UCLAF ORGAMOL SA INNOPHOS YODOGAWA PHARMACEUTICAL CO LTD EI DUPONT DE NEMOURS AND CO A II I 9/4/1984 2/1/1985 TEVA PHARMACEUTICAL INDUSTRIES LTD FH FAULDING & COMPANY LTD FLUOROMETHOLONE-17-ACETATE MICRONIZED-MFG IN KALAMAZOO,MI MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. ESTRADIOL USP RIBAVIRIN DIBASIC CALCIUM PHOSPHATE ,DIHYDRATE (UNMILLED BULK PRODUCT) DOXYLAMINE SUCCINATE USP XXI MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WILMINGTON, DELAWARE. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CONAVANAS, CAROLINE PLANT, PUERTO RICO. ETINTIDINE HYDROCHLORIDE 5-AMINOSALICYLIC ACID TRIBASIC CALCIUM PHOSPHATE (BULK POWDER ) PLASTIC BOTTLES AS MFG IN EAST RUTHERFORD,N.J. MERLON PRODUCTS IN M40RF-SM SERIES N-METHYLFORMIDE (CODE NO. W150-9) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MILROY, PA. TRIFLUOPERAZINE SANTOPRENE (R) THERMOPLASTIC ELASTOMER,270 GRADE SERIES PROCESSING OF STERILE BULK CLAVULANATE POTASSIUM II 1/21/1985 III 11/2/1984 STATUS Type SUBMIT DATE I I I I A I I I A A I I II II II III II II II II II II III II I 1/4/1985 11/20/1984 1/22/1985 1/7/1985 12/10/1984 12/20/1984 1/4/1985 11/20/1984 12/20/1984 1/18/1985 1/25/1985 11/20/1984 1/15/1985 HOLDER ISP INNOPHOS WITCO CHEM CO INC ALUMINUM COMPANY OF AMERICA ROHM AND HAAS CO LLC FIS FABBRICA ITALIANA SINTETICI SPA MTM CHEMICALS INC INNOPHOS INC YUNG ZIP CHEMICAL IND CO LTD PCAS MOBAY CHEMICAL CORP INNOPHOS INC EI DUPONT DE NEMOURS AND CO SUBJECT DEXBROMPHENIRAMINE MALEATE TRIBASIC CALCIUM PHOSPHATE ( GRANDULAR ) FOMREZ PRODUCTS COATED ALUMINUM SHEET WITH TEXTURING LUBRICANT DUOLITE AP 143 (CHOLESTYRAMINE RESIN USP ) CLOMIPHENE CITRATE D,I-BROMPHENIRAMINE MALEATE DIBASIC CALCIUM PHOSPHATE ,ANHYDROUS ACETAMINOPHEN AND MEFENAMIC ACID VALPROIC ACID MERLON PRODUCTS (MERLON M-40RF-1000 ) DIBASIC CALCIUM PHOSPHATE ,DIHYDRATE (BULK) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DEEPWATER, NEW JERSEY . LOW DENSITY POLYETHYLENE PRODUCTS (STAMYLAN 1300 SERIES )

4Q2012

DSM MARKETING CENTRE CHEMICALS & POLYMERS MALLINCKRODT SPECIALTY CHEMICALS CO ACETAMINOPHEN AS MANUF. IN LYNDHURST,N.J.

THIORIDAZINE HCL 400MG S.R.TABS (IN SYNCHRON VEHICLE) AS MFG INWOOD,NY

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4Q2012EXCEL DMF# 5703 5704 I 5705 I 5706 I 5707 5708 5709 5710 I 5711 5712 5713 5714 I 5715 5716 I 5717 5718 5719 5720 5721 5722 5723 5724 5725 I 5726 5727 I 5728 5729 I 5730 5731 I 5732 5733 5734 5735 I I A I II II IV I 2/28/1985 2/26/1985 2/28/1985 2/27/1985 GEDEON RICHTER SANDOZ PHARMS CORP DIV SANDOZ INC GATTEFOSSE SAS SERONO LABORATORIES INC I II I 3/5/1985 3/5/1985 ROUSSEL-UCLAF ACME UNITED CORP I II I 3/6/1985 3/4/1985 CHEMISCHE WERKE LAHR GMBH QUALITY CHEMICALS INC I II I 2/4/1985 2/7/1985 A A I I I A I I II IV III II II II II II II 2/6/1985 2/11/1985 2/15/1985 2/25/1985 2/19/1985 2/22/1985 2/27/1985 2/14/1985 12/3/1984 FERMION OY GATTEFOSSE SAS LABELTAPE MEDITECT INC SIEGFRIED AG BACHEM FINE CHEMICALS INC ALBEMARLE CORP PFIZER INC PROCOS SPA RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA KLINGE PHARMA CO CONTAINER SUPPLY CO I II I 2/11/1985 2/13/1985 GLAXOCHEM LIMITED IG SPRUHTECHNIK GMBH I I A IV III III I 2/22/1985 2/19/1985 2/14/1985 1/11/1985 FIRMENICH INC HUB PLASTICS INC BERRY PLASTICS CORP PACKAGE CRAFT INC I I I I II IV I 2/11/1985 1/21/1985 2/11/1985 1/30/1985 GLAXO WELLCOME INC GEDEON RICHTER PLC SUMITOMO CHEMICAL AMERICA INC BALL UNIMARK PLASTICS DIV BALL CORP I 1/31/1985 SIMBEC RESEARCH LTD I 2/4/1985 ZUMBRO INC STATUS Type SUBMIT DATE I II I 2/12/1985 1/30/1985 HOLDER SIEGFRIED AG BALL UNIMARK PLASTICS DIV BALL CORP SUBJECT BENZPHETAMINE HYDROCHLORIDE MANUFACTURING SITE, FACILITIES, PERSONNEL,AND GENERAL OPERATING PROCEDURES IN MILROY, PA. CENTER II. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES . MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. MANUFACTURING SITE AND FACILITIES FOR ANNAN, UK PLANT NORGESTIMATE AS MFG. INBUDAPEST, HUNGARY EGG YOLK PHOSPHATIDE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GREENVILLE, SOUTH CAROLINA, CENTER II. CHEMODERM 1001 BLOW MOLDED CONTAINER PRODUCTS INJECTION MOLDED/LINED CLOSURES MANUFACTURED IN BALTIMORE, MD. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. LABETALOL HYDROCHLORIDE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WEHR/BADEN. DILTIAZEM HCL TRANSCUTOL, MANUFACTURED IN SAINT-PRIEST CEDEX, FRANCE TRANSDERMAL DRUG DELIVERY SYSTEM HYDRALAZINE HYDROCHLORIDE GROWTH HORMONE RELEASING FACTOR (GRF),(1-44)AMIDE,HUMAN (BULK) ORPHENADRINE CITRATE USP ZINC GLUCONATE DISOPYRAMIDE PHOSPHATE ALPHA-METHYLDOPA DIPIVEFRINE HCL. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. CROTAMITON MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TYRONE, PA. DIHYDROTACHYSTEROL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. DISOPYRAMIDE PHOSPHATE PHENIRAMINE MALEATE LABRASOL AS MFG IN THE SAINT-PRIEST, (LYON), FRANCE VIA CASILINA PLANT IN ROME, ITALY

4Q2012

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4Q2012EXCEL DMF# 5736 I 5737 I 5738 I 5739 5740 5741 5742 5743 I 5744 5745 I 5746 5747 I 5748 5749 5750 5751 5752 I 5753 5754 5755 I 5756 5757 A 5758 5759 5760 I 5761 5762 5763 I 5764 I 5765 I II 3/27/1985 BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG I 11/30/1984 I I II V II 3/19/1985 2/28/1985 3/28/1985 LYPHOMED INC SQUIBB DIAGNOSTICS ORTHO DIAGNOSTIC SYSTEMS DIV ORTHO PHARMACEUTICAL LTD TEXBERRY CONTAINER CORP I A I II I 2/18/1985 2/18/1985 3/18/1985 I II II 3/29/1985 2/19/1985 LUDWIG HEUMANN AND CO GMBH MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC NOVO NORDISK AS DOW CHEMICAL CO PLAISTOW LTD I I II II I 3/27/1954 3/20/1985 2/27/1985 BOEHRINGER INGELHEIM PHARMA KG CILAG CHEMIE AG SHIONOGI QUALICAPS INC A I I A II II II IV I 3/11/1985 3/4/1985 3/11/1985 3/21/1985 3/18/1985 I II II 3/20/1985 3/13/1985 I II II 2/28/1985 2/12/1985 I A I I II II II II I 3/13/1985 2/27/1985 3/11/1985 8/17/1984 3/11/1985 TECHNOCHEMIE GMBH GEDEON RICHTER PLC PROFARMACO SRL ELI LILLY INDUSTRIES INC LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO GEDEON RICHTER RP SCHERER NORTH AMERICA DIV RP SCHERER CORP ASTELLAS PHARMA INC SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT BASF PHARMA EVIONNAZ SA MICROCHEM LABORATORIES IRELAND LTD DIOSYNTH INC VIRGINIA DARE EXTRACT CO INC CP PACKAGING INC I 3/1/1985 II 2/12/1985 RP SCHERER NORTH AMERICA DIV RP SCHERER CORP TRINITY TECHNOLOGIES CORP STATUS Type SUBMIT DATE I 3/5/1985 HOLDER PARKE DAVIS DIV WARNER LAMBERT CO SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES ENPROSTIL CAPSULES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DETROIT, MICHIGAN. GUANABENZ ACETATE ETHINYL ESTRADIOL MECLOFENAMATE SODIUM ALMITRINE BISMESYLATE TABLETS

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BOUND BROOK, NEW JERSEY. MESTRANOL-MFG BY CHEM.WORKS OF GEDEON RICHTER,LTD-TRADED BY MEDIMPEX TEGRETOL S.R. CAPSULES FAMOTIDINE MANUFACTURED IN JAPAN LORAZEPAM METOLAZONE CONTRACT MICRONIZATION SERVICES LOCATED IN FIORENZUOLA D'ARDA, ITALY PREGNANT MARE SERUM GONADOTROPIN (PMSG)(CRUDE) EXTRACTS & FLAVORS-PROCESSED IN BKLYN,NY-3RD AVE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN JAMESBURG, NEW JERSEY. CAFFEINE AS PROCESSED IN INGELHEIM FACILITIES DISULFIRAM MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES MANUFACTURED BY LILLY RESEARCH CENTER IN ENGLAND. METOCLOPRAMIDE HCL. NICOTINE RESIN COMPLEX 20% PRODUCTION OF INSULIN CHOLESTYRAMINE USP MANUFACTURED IN GARESSIO PONTE, GARESSIO. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LITTLE ISLAND, COUNTY CORK. ISOSORBIDE DINITRATE INJECTION (50ML AND 100ML) RUBIDIUM-82 PERCLINICAL STUDIES PHOTOFRIN AS MFG UNDER CONTRACT IN RARITAN,NJ FACIL.FOR PHOTOFRIN MED. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. ERGOTAMINE TARTRATE

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4Q2012EXCEL DMF# 5766 I 5767 5768 I 5769 5770 I 5771 I 5772 5773 5774 I 5775 I 5776 5777 5778 5779 A 5780 5781 I 5782 C 5783 5784 5785 I 5786 5787 5788 5789 5790 5791 A 5792 5793 5794 5795 5796 5797 I I I A A I II II I II II IV 4/4/1985 4/10/1985 6/1/1985 4/10/1985 4/3/1985 3/28/1985 I I I I I II II II II II II 4/10/1985 3/29/1985 3/29/1985 3/15/1985 4/18/1985 3/27/1985 I I II II II 3/22/1985 4/16/1985 3/27/1985 UNICHEM LABORATORIES LTD SIGMA F AND D DIV LTD ORCHIMIE SA (PRODUITS CHIMIQUES ET BIOCHIMIQUES) JAGSONPAL PHARMACEUTICALS PVT LTD PHARMACIA AND UPJOHN INC ZAMBON SPA MALLINCKRODT INC PENINSULA LABS BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG SCHERING AG BASF AKTIENGESELLSCHAFT BRUNSWICK TECHNETICS LONZA AG FERMION OY GATTEFOSSE ESTABLISSEMENTS II 4/8/1985 I II II 4/12/1985 3/28/1985 I I I II II II II 3/8/1985 4/9/1985 3/27/1985 5/4/1984 FABBRICA ITALIANI SINTETICI SPA ORION CORP FARMOS CHEMICAL PLANT SIGMA F AND D DIV LTD BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG AJAY CHEMICALS INC NORTH EAST SIXTH PHARMACEUTICAL FACTORY XTTRIUM LABORATORIES INC I 3/21/1985 NORAMCO OF DELAWARE INC I A II II I 4/1/1985 3/27/1985 4/3/1985 DOW CHEMICAL CO MICHIGAN DIV NV ORGANON MASTER-PAK LABORATORIES INC I 4/1/1985 I IV IV 3/7/1985 4/8/1985 EKA NOBEL INC PAPER CHEMICALS DIV SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP DELTA SYNTHETIC CO LTD A V I 3/27/1985 2/28/1985 STERIS-ISOMEDIX SQUIBB DIAGNOSTICS STATUS Type SUBMIT DATE I 3/15/1985 HOLDER INJECTRONICS INC SUBJECT MANUFACTURING SITE FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BURLINGTON, NORTH CAROLINA. CONTRACT STERILIZATION FACILITY IN SANDY, UTAH. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. BEROCELLS 584 AND 588 EMPTY HARD GELATIN CAPSULES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TAIPEI HSIEN, CHINA. ETHYCELLULOSE DISPERSIONS DROPERIDOL AS MANUF. IN OSS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PATERSON, NEW JERSEY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WILMINGTON, DELAWARE. PRAZEPAM TAMOXIFEN (10MG. TABLET) L-B-3,4-DIHYDROXYPHENYLALANINE (L-DOPA) AND METHYL ESTER HCL. EPHINEPHRINE BITARTRATE

4Q2012

POTASSIUM IODIDE USP AS MFG IN THE POWDER SPRINGS, GEORGIA FACILITY TRIMETHOPRIM USP BULK MANUFACTURED IN SHENYANG CHINA CHLORHEXIDINE GLUCONATE B.P-81 (ESUB) AS MANUFACTURED IN MT. PROSPECT, ILLINOIS METRONIDAZOLE USP DIPYRIDAMOLE: SPECIFICATIONS AND RELABELLING THIORIDAZINE TRIMETHOPRIM DIFLORASONE DIACETATE DOPAMINE HCL USP XX -MFG ALMISANO DI LONIGO (VICENZA) ITALY PROCEDS & CONTRLS FOR PROCESSING OF INDIUM IN-111(CHL & CITRATE) LEUCINE-ENKEPHALIN ATROPINE AS MFG IN THE INGELHEIM AM RHEIN FACILITIES GADOPENTETIC ACID,MEGLUMINE SALT BETA-CAROTENE CAPSULES,50MG. PRODUCTION OF MEMBRANE FILTER PRODUCTS ETODOLAC AS MANUFACTURED IN VISP, SWITZERLAND TOLNAFTATE USP XX MAISINE AS MANUF. IN SAINT-PRIEST FACILITY

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4Q2012EXCEL DMF# 5798 A 5799 I 5800 5801 5802 5803 I 5804 I 5805 5806 5807 I 5808 5809 5810 5811 5812 5813 5814 I 5815 5816 5817 5818 5819 5820 5821 5822 A 5823 I 5824 5825 5826 5827 5828 5829 5830 5831 5832 I I I A A A I I I II II II II III V II II II 5/23/1985 5/14/1985 5/6/1985 5/10/1985 4/17/1985 5/15/1985 5/22/1985 5/10/1985 5/15/1985 III 5/13/1985 A I I I I I A II II III II II II V II 4/30/1985 4/8/1985 3/27/1985 5/6/1985 4/29/1985 5/13/1985 4/29/1985 5/29/1985 NAPP CHEMICALS INC ALBERT DAVID LTD ABBOTT INDUSTRIES INC BASF SE HOECHST CELANESE CORP FOREST LABORATORIES INC STERIS ISOMEDIX SERVICES BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG ARCO CHEMICAL COMPANY DIV OF ATLANTIC RICHFIELD CO SIGMA F AND D DIV LTD ORGAMOL SA BASF AKTIENGESELLSCHAFT MEDICHEM SA VAN BLARCOM CLOSURES INC STERIS ISOMEDIX SERVICES SOLVAY PHARMACEUTICALS ORION CORP LTD FERMION PENINSULA LABS I A I I I I III II II II II II I 4/17/1985 4/11/1985 5/7/1985 5/10/1985 5/8/1985 5/7/1985 5/10/1985 MOBAY CHEMICAL CORP DELTA SYNTHETIC CO LTD GANES CHEMICALS INC DIOSYNTH INC GA TECHNOLOGIES INC ORGAMOL SA MASCHMEIJER AROMATICS BV I I II III I 4/15/1985 2/1/1985 4/5/1985 L&P PROM EXPORT AS FORTIFIBER CORP RADIATION STERILIZERS INC I 4/24/1985 I I I II I II II 4/9/1985 4/23/1985 2/27/1985 4/23/1985 BAYER COMPAGNIE ORIS INDUSTRIE ALCHYMARS ORCHIMIE SA (PRODUITS CHIMIQUES ET BIOCHIMIQUES) BEHRING DIAGNOSTICS I 4/9/1985 DAINIPPON PHARMACEUTICAL CO LTD STATUS Type SUBMIT DATE III 4/18/1985 HOLDER ALPHA PACKAGING SUBJECT

4Q2012

PACKAGING MATERIALS MANUFACTURED IN YPSILANTI, MICHIGAN AND THOMASVILLE, GEORGIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN OSADA, JAPAN. MYCOSPOR (BIFONAZOLE) SOLUTION 1% LABORATORY OF BIOMEDICAL IMAGING PRODUCTS TRIHEXIPHENIDYL HYDROCHLORIDE PROCHLORPERAZINE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LA JOLLA, CALIFORNIA. PHENYLACETIC ACID PACKAGING MATERIALS/CAP LINING AS MFG IN ATTLEBORO,MASSACHUSSETTS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DECATUR, GEORGIA. NYDUR C-38F AS MFG IN KREFELD/UERDINGEN FACILITY (GERMANY) GUAIFENESIN MFG IN TAIPEI,HSIEN,TAIWAN CYCLOBENZAPRINE HYDROCHLORIDE PREGNANT MARE SERUM GONADOTROPIN (PMSG), CRUDE YTTRIUM-90 RAW MATERIAL PRODUCTION METOCLOPRAMIDE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. TRIMETHOPRIM USP CHLORPROPAMIDE USP XX PLASTIC CONTAINER PRODUCTION IN NEW JERSEY VITAMIN E ACETATE TOLAZAMIDE USP MFG IN COVENTRY,RHODE ISLAND FACIL ON QUIDNICK STREET PENTAERYTHRITOL TETRANITRATE (P.E.T.N.) 80MG. & 160MG C.R. TABLETS CONTRACT STERILIZATION FACILITY IN WHIPPANY, NJ EPINEPHRINE ARRALENE POLYSTYRENE RESINS TETRATETHYLAMMONIUM CHLORIDE SUCRALFATE AS MFG IN THE EVIONNAZ,SWITZERLAND FACILITIES VITAMIN E (400 I.U.) SOFT GELATIN CAPSULE CYCLOBENZAPRINE HCL. CHILD RESISTANT CLOSURES CONTRACT STERILIZATION FACILITY IN NORTHBOROUGH, MA. URSODEOXYCHOLIC ACID (250MG. TABLETS) IMIPRAMINE HCL. CORTICOTROPIN RELEASING FACTOR (HUMAN RA CRF)

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4Q2012EXCEL DMF# 5833 5834 5835 I 5836 5837 I 5838 5839 5840 5841 5842 5843 5844 5845 5846 I 5847 5848 5849 5850 I 5851 5852 5853 5854 5855 I 5856 I 5857 5858 5859 5860 I 5861 5862 5863 5864 5865 5866 I 5867 I II 5/29/1985 DIOSYNTH INC A I I A I II II II II II I 6/5/1985 6/5/1985 5/22/1985 6/6/1985 5/17/1985 6/14/1985 ALBEMARLE CORP BACHEM FINE CHEMICALS INC SCHERING AG DIPHARMA FRANCIS SRL BASF AKTIENGESELLSCHAFT WINTEK INC A I I II II II I 6/3/1985 6/3/1985 6/14/1985 6/13/1985 I 5/20/1985 KEY PHARMACEUTICALS INC SUB SCHERING PLOUGH CORP MALLINCKRODT INC FOREST LABORATORIES INC FINE ORGANICS LTD BALENCO ENTERPRISES INC I I I I II II II II I 5/20/1985 5/22/1985 3/9/1985 5/20/1985 4/30/1985 BASF AKTIENGESELLSCHAFT ORGAMOL SA CELLULOSE PRODUCTS OF INDIA LTD PALISADES PHARMACEUTICALS INC ZETACHRON INC I I A II II IV I 4/19/1985 5/30/1985 5/22/1985 3/20/1985 I I I A I I I I II II II IV II I II II I 5/23/1985 5/6/1985 5/17/1985 5/21/1985 5/23/1985 5/10/1985 5/7/1985 5/23/1985 3/18/1985 AJINOMOTO USA INC BASF AKTIENGESELLSCHAFT PENNISULA LABORATORIES INC DOW CHEMICAL CO LILLY RES LABS DIV ELI LILLY CO 3M PHARMS BASF AKTIENGESELLSCHAFT AJINOMOTO USA INC SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT JANSSEN PHARMACEUTICA NV RHODIA INC GATTEFOSSE SAS PHARBITA BV A II I 3/29/1985 4/24/1985 PHARMAZELL GMBH FINORGA STATUS Type SUBMIT DATE I I II II I 5/20/1985 5/7/1985 2/25/1985 HOLDER BASF AKTIENGESELLSCHAFT SCHERING AG FIDIA PHARMACEUTICALS SUBJECT VITAMIN E (400 I.U.)/BETA-CAROTENE(25MG.) SOFT GELATIN CAPSULES BETAMETHASONE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ABANO TERMA (PADOVA) ITALY. N-ACETYL-L-CYSTEINE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CHASSE-SUR-RHONE, FRANCE. ALPHA-KETO ACID SALTS OF L-AMINO ACIDS VITAMIN C (1,000MG.)TABLET & VITAMIN C PLACEBO TABLETS BOMBESIN DOWEX 1 & 2 ANION EXCHANGE RISIN VIALS BOVINE PANCREAIC POLYPEPTIDE MFG. SITE,LOUGHBOROUGH,ENGLAND

4Q2012

BETA-CAROTENE,VITAMIN E,BETA-CAROTENE/VITAMIN E PLACEBO GELATIN CAPS. KETO ACID MIXTURE MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN BASLE, SWITZERLAND. LEVOCABASTINE HCL.(BULK) ASPIRIN AND ASPIRIN STARCH GRANULATION LABRAFIL M 2125 CS AS MFG. IN SAINT-PRIEST, FRANCE MANUFACTURING SITE, FACILTIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ZANADAM. BETA-CAROTENE (25MG.) SOFT GELATIN CAPSULES CLOFIBRATE MICROCRYSTALLINE CELLULOSE NF/FCC (EX-CEL TM) YOCON (YOHIMBINE) TALBETS 1/12GR. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN STATE COLLEGE. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDUES IN PUERTO RICO. MORPHINE SULFATE (ESUB) AS MANUFACTURED IN ST LOUIS MO ERYTHROMYCIN 500MG. C.R.TABLETS 1,METHYLAMINO-1-METHYTHIO-2-NITROETHENE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN COMPTON, CALIFORNIA. PROPRANOLOL HCL. (DES-GLY 10)-{ D-TRP6-PRO 9-ETHYLAMIDE }-LEUTINIZING HORMONE BETAMETHASONE VALERATE CYCLOBENZAPRINE HCL. LUROTIN TM BETA-CAROTENE (DRY POWDER FORMULATION) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MEDFIELD, MASSACHUSETTS. ISOLATION AND PURIFICATION OF HEPARIN SODIUM USP FROM BEEF LUNGS

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4Q2012EXCEL DMF# 5868 5869 5870 I 5871 5872 5873 5874 I 5875 I 5876 5877 5878 5879 5880 5881 5882 5883 5884 5885 5886 I 5887 5888 5889 5890 5891 5892 5893 I 5894 5895 5896 5897 5898 5899 I 5900 5901 5902 5903 I I I I II II II I 4/22/1985 7/2/1985 7/9/1985 7/5/1985 LUNDBECK PHARMACEUTICALS ITALY SPA DOW CHEMICAL CO MICHIGAN DIV BACHEM FINE CHEMICALS INC SYNTHELABO PHARMACIE A I I I I IV II II II III I 6/13/1985 4/19/1985 6/24/1985 6/10/1985 6/28/1985 6/13/1985 I I I I I A II II II II II II I 6/5/1985 3/27/1985 5/21/1984 6/21/1985 6/28/1985 6/3/1985 4/18/1985 A I A I I I A I A I II IV II II II II II II II II I 6/10/1985 5/6/1985 5/29/1985 6/21/1985 5/24/1985 6/12/1985 6/27/1985 3/11/1985 6/7/1985 6/14/1985 4/18/1985 I 6/5/1985 I I I II III II II 6/13/1985 6/12/1985 6/7/1985 5/20/1985 BALENCO ENTERPRISES INC REXAM MEDICAL PACKAGING INC PENINSULA LABS STATUS Type SUBMIT DATE I I II III I 6/12/1985 6/20/1985 6/17/1985 HOLDER ALDRICH CHEMICAL COMPANY INC SCOTFOAM CORP SUB GENERAL FELT IND PRAGMA BIO TECH INC SUBJECT N-ACETYL-DL-PENICILLAMINE CRP(R) 9900-1.2F GOLD MA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BLOOMFIELD, NEW JERSEY. TRIPROLDINE HCL. PLASTIC FLEXIBLE POUCHES PARAHYROID HORMONE (HUMAN),1-34

4Q2012

TEMMLER WERKE VEREINIGTE CHEMISCHE CLONIDINE HCL. 0.6MG. C.R. CAPSULES FABRIKEN BEECHAM PHARMACEUTICALS PTE LTD MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN SINGAPORE MOEHS IBERICA SL LIDOCAINE USP XXI AND LIDOCAINE HCL. USP XXI HAAGEN CHEMIE BV ORGANON API INC ALDRICH CHEMICAL COMPANY INC SIGMA F AND D DIV LTD CIPLA LTD PUROLITE CO SIPSY CHIMIE FINE S.C.A. FARCHEMIA SRL GLAXOCHEM LTD KNOLL PHARMACEUTICAL CO UNIT BASF K&F CORP BEECHAM PHARMACEUTICALS PTE LTD ALFRED BENZON AS CIBA GEIGY LTD BAYER PENCO OF LYNDHURST INC SANDOZ GMBH KNOLL PHARMACEUTICAL CO UNIT BASF K&F CORP MALLINCKRODT INC ALFRED BENZON AS NIPPON RIKAGAKUYAKUHIN CO LTD HELSINN CHEMICALS SA ACCU FORM INC TEST PAK INC MAGNESIUM STEARATE HEPARIN SODIUM CRUDE 1-(3-CHLOROPHENYL) PIPERAZINE HCL. 5-AMINOSALICYLIC ACID AS ASSAYED AND REPACKAGED NIFEDIPINE USP XXI SODIUM POLYSTYRENESULFONATE AS MANUFACTURED IN PONTYCLUN, WALES, UK PROPRANOLOL HCL & BASE CARBADOX ALBUTEROL (SALBUTAMOL) AS PRODUCTED IN THE MONTROSE,SCOTLAND FACILITY MANUFACTURING SITE,FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LUDWIGSHAFEN, GERMANY. 6-AMINO PENICILLANIC ACID IBUMETIN (IBUPROFEN) TABLETS:200,300,400,&600 MG. CGP 17,582B ISONIAZID (NEOTEBEN) HYDROCODONE BITARTRATE POWDER 6-METHYLERGOLENE-8-CARBOXYLIC ACID MANUFACTURING SITE, FACILITIES, PERSONNEL, GENERAL OPERATING PROCEDURES IN LUDWIGSHAFEN, GERMANY. STEAR-O-WET M (ESUB) AS MANUFACTURED IN GREENVILLE, ILLINOIS KALINORM CONTROLLED RELEASE TALBETS 750MG. AMINO ACIDS MANUFACTURED IN ASHIKAGA, JAPAN. GUANABENZ ACETATE PACKAGING MATERIALS. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES FOR CONTRACT PACKAGING FACILITY IN WHIPPANY, NJ. TRIMIPRAMINE MALEATE (ESUB) AS MANUFACTURED IN PADOVA, ITALY ASPIRIN USP AS MANUFACTURED IN MIDLAND, MICH. LUTEINIZING HORMONE-RELEASING HORMONE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN AMILLY, FRANCE. Page

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4Q2012EXCEL DMF# 5904 5905 5906 I 5907 5908 5909 5910 5911 5912 A 5913 5914 I 5915 5916 5917 I 5918 5919 I 5920 5921 I 5922 5923 I 5924 5925 5926 5927 I 5928 5929 I 5930 5931 I 5932 5933 I 5934 5935 I I III I 6/28/1985 7/15/1985 I III II 7/16/1985 7/26/1985 NYPRO INC ORCHIMIE SA (PRODUITS CHIMIQUES ET BIOCHIMIQUES) 3M MISSION PHARMACAL CO I II I 5/22/1985 7/31/1985 I II II 7/15/1985 7/10/1985 I A A II II II II 7/5/1985 7/19/1985 7/2/1985 6/24/1985 SYNTHELABO PHARMACIE JANSSEN PHARMACEUTICA NV EVONIK TECHNOCHEMIE GMBH SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT HEXACHIMIE HUMAN INSTITUTE FOR SEROBACTERIOLOGICAL PROD & RES DELTA SYNTHETIC CO LTD ILKIM AS I II I 7/24/1985 7/3/1985 FABBRICA ITALIANI SINTETICI SPA PACO PHARMACEUTICAL SERVICES INC CLORAZEPATE DIPOTASSIUM MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LAKEWOOD, NEW JERSEY. KETOISOLEUCINE L-ORNITHINE SALT TERCONAZOLE (PRODUCT # R42470) CHLORHEXIDINE BASE MANUFACTURED IN HANAU, GERMANY. TIAMULIN FUMARATE PROPACETAMOL HYDROCHLORIDE NAKSOL STOCK SOLUTION CHLORHEXIDINE GLUCONATE (BULK) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TUZLA (ISTAMBUL) TURKEY. INJECTION MOLDED MATERIALS ACEPROMAZINE MALEATE POROUS MEMBRANE TAPE MANUFACTURING SITE, FACILITIES, PERSONNEL,AND GENERAL OPERATING PROCEDURES IN SAN ANTONIO, TEXAS. I II II 7/5/1985 7/20/1985 SYNTHELABO PHARMACIE HOECHST AG I III III 6/17/1985 7/17/1985 I I II IV II 7/5/1985 6/17/1985 4/15/1985 SYNTHELABO PHARMACIE AVANTI POLAR LIPIDS INC SHANGHAI NO 6 PHARMACEUTICAL FACTORY KINETICON PHARMACEUTICALS INC ELI LILLY INDUSTRIES INC I II I 7/10/1985 7/5/1985 I I I I I II II II II II II 7/5/1985 6/26/1985 6/27/1985 7/3/1985 7/5/1985 5/15/1985 STATUS Type SUBMIT DATE I I II II II 7/1/1985 7/3/1985 8/23/1985 HOLDER FOREST LABORATORIES INC BAYER SANDOZ HUNINGUE SA PRODUCTION PHARMA SYNTHELABO PHARMACIE FINE CHEMICALS CORPORATION BRACCO IND CHIMICA SPA TRIOCHEM PRODUCTS LTD SYNTHELABO PHARMACIE BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG ALBRIGHT AND WILSON LTD HN PHARMA AG SUBJECT QUINIDINE GLUCONATE 650 MG. C.R. TABLETS BAYPRESS R(NITRENDIPINE)TABLETS 5MG.,10MG.AND 20MG. TIAMULIN BASE KETOVALINE L-LYSINE SALT SILVER SULFADIAZINE PYRAZINAMIDE PARACETAMOL USP (ACETAMINOPHEN USP) KETOLEUCINE L-HISTIDINE SALT PHENYLEPHRINE HYDROCHLORIDE ALBRITESODIUMMONOFLUOROPHOSPHATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. KETOVALINE L-ORNITHINE SALT DISTEAROYLGLYCEROPHOCHLINE

4Q2012

DIPYRIDAMOLE MANUFACTURED IN SHANGHAI, PEOPLE'S REPUBLIC OF CHINA. TPH BIOMED.POLYMERS(TYPE D SER.)MFG.TYNDALE PLAINS-HUNTER,RINGOES,N.J. QUALITY CONTROL PROCEDURES FOR IN-COMING INSPECTION OF PACKAGING COMPONENTS USED IN INDIANA KETOLEUCINE L-LYSINE SALT LIDOCAINE HYDROCHLORIDE AND BASE(BULK)MFG.FRANKFURT(MAIN) GERMANY FAC

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4Q2012EXCEL DMF# 5936 I 5937 I 5938 I 5939 I 5940 5941 5942 5943 I 5944 I 5945 5946 5947 5948 5949 I 5950 5951 5952 5953 5954 5955 5956 I 5957 5958 5959 5960 I 5961 5962 5963 I 5964 5965 5966 5967 A I I A II II II II 8/7/1985 8/26/1985 8/8/1985 8/13/1985 CALIFORNIA BIOTECHNOLOGY INC GLAXOCHEM LIMITED ESTEVE QUIMICA SA SARTORIUS STEDIM NORTH AMERICA INC I I II II I 8/27/1985 8/16/1985 8/8/1985 FMC CORP SOCIETE INDUSTRIELLE DES OLEAGINEUX PAR PHARMACEUTICAL INC I I I III II II I 7/31/1985 8/15/1985 8/9/1985 7/30/1985 VICTOR TUBE CORP KV PHARMACEUTICAL CO LIPHA SA FREEDOM CHEMICAL DIAMALT GMBH I A I I A I II II II II II III I 7/30/1985 8/9/1985 8/14/1985 6/26/1985 7/9/1985 7/25/1985 7/16/1985 FMC CORP MERCK SANTE SAS SANKYO CO LTD PENINSULA LABS BOEHRINGER INGELHEIM CHEMICALS INC NATIONAL STARCH & CHEMICAL CORP NYPRO INC I A I I II III II II I 8/5/1985 8/2/1985 8/6/1985 8/7/1985 8/6/1985 II 7/17/1985 SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT DIOSYNTH BV CATTY CORP RHONE-POULENC SANTE WYCKOFF CHEMICAL CO INC INVAMED INC I I I II II II I 7/25/1985 6/26/1985 7/24/1985 4/26/1985 II 7/26/1985 ORCHIMIE SA (PRODUITS CHIMIQUES ET BIOCHIMIQUES) HOECHST AG AMERICAN CHEMICAL INDUSTRIAL CORP PHARM ECO LABORATORIES INC 3M PHARMS I 7/16/1985 II 5/31/1985 KOTHARI PHYTOCHEMICALS INTERNATIONAL NYPRO INC STATUS Type SUBMIT DATE I 7/18/1985 HOLDER DOW CHEMICAL CO MICHIGAN DIV SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PITTSBURG, CAL. PROPRANOLOL HYDROCHLORIDE

4Q2012

COMBINATION I & III FOR INJECTION MOLDED MATERIALS MANUFACTURED IN PUERTO RICO. THIOTHIXENE DIHYDROCHLORIDE ANHYDROUS ANTIPYRINE PROCHLORPERAZINE EDISYLATE USP XXI D,L,N,-BENZYL-ALPHA-ACETOXPHENYLACETAMIDE (BPA) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RAMA-GAN, ISRAEL. 6-METHYLERGOLINE-8B-CARBOXYLIC ACID MIANSERIN HYDROCHLORIDE A COMBO.TYPES I/III PROD.VINYL HEATSEALABLE ALUM.FOILS,HUNTLY,IL.FACIL TRIMEPRAZINE TARTRATE PRILOCAINE HYDROCHLORIDE USP MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FAIRFIELD, NEW JERSEY. TETRAPOTASSIUM PEROXYDIPHOSPHATE METFORMIN HYDROCHLORIDE (LA 6023) CEFMETAZOLE SODIUM INJECTION(VIALS) AS MFG.IN THE HIRASUKA MFG.FACIL. ALPHA-ARIAL NARIURETIC PEPTIDE (HUMAN 1-28) METHOCARBAMOL PRESSURE SENSITIVE ADHESIVES FOR TRANSDERMAL MEDICAL APPLICATION INJECTION MOLDED MATERIALS MANUFACTURED BY AMITECH INC IN MARIETTA, GEORGIA. PRODUCTION OF COLLAPSIBLE TUBES IN HARRISONBURG,VA. CAPTOPRIL TABLETS, 100MG. METFORMIN ( LA-6023),500MG.&850MG. TABLETS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RAUBLING (FRG). CELLULOSE TRIACETATE SEMI-SYNTHETIC GLYCERIDES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SPRING VALLEY, NEW YORK. NAZDEL TM MEMBRANE PERMEATION ENHANCER O/4 DIHYDROCHLORIDE DIHYRATE (CPZ ROUTE) ALPHA METHYLDOPA FILTER MEMBRANE MATERIALS MANUFACTURED AT GOTTINGEN, GERMANY AND YAUCO, PUERTO RICO

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4Q2012EXCEL DMF# 5968 I 5969 5970 I 5971 5972 5973 5974 5975 I 5976 I 5977 5978 5979 5980 5981 5982 5983 5984 5985 A 5986 5987 5988 5989 5990 5991 5992 I 5993 5994 5995 5996 5997 5998 5999 6000 6001 6002 6003 I I I I I I I I I A I II II II III II II II III I II II 8/26/1985 9/6/1985 8/13/1985 9/4/1985 8/8/1985 5/28/1985 9/9/1985 8/30/1985 8/13/1985 7/30/1985 8/13/1985 I I A I A A II I III I II II IV 9/3/1985 9/5/1985 8/30/1985 9/9/1985 8/19/1985 9/3/1985 9/6/1985 A I A I I I I A II II V II II II II II V 8/19/1985 8/5/1985 8/16/1985 8/27/1985 9/4/1985 9/4/1985 8/29/1985 8/27/1985 9/6/1985 TRIFARMA SPA EURAND AMERICA INC SANOFI AVENTIS SPA BOEHRINGER INGELHEIM CHEMICALS INC SELOC AG ALBERT DAVID LTD SCHERING AG CAMBREX KARLSKOGA AB OSO BIOPHARMACEUTICALS MANUFACTURING LLC ABBOTT LABS SCM CORPORATION 3M DRUG DELIVERY SYSTEMS ABLE LABORATORIES INC TRIFARMA SPA TEVA PHARMACEUTICAL INDUSTRIES LTD I 8/13/1985 PDI LABORATORIES INC I A I A II II II II I 8/7/1985 8/13/1985 7/26/1985 8/20/1985 8/6/1985 SOCIETA ITALIANA CORTICOSTEROIDI SPA BOEHRINGER INGELHEIM CHEMICALS INC STEPAN CHEMICAL COMPANY NAPP TECHNOLOGIES LLC SMITHKLINE & BECKMAN INC I IV I 8/27/1985 7/19/1985 FMC CORP BIO NUTRITION INC CELLULOSE ACETATE BUTYRATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RONKONKOMA, NEW YORK. DEXAMETHASONE SODIUM PHOSPHATE AS MFG. IN RHO (MILAN) ITALY GUAIFENESIN LAHANOL LAL SULFANILAMIDE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TONBRIDGE, KENT, ENGLAND. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES MINOXIDIL USP INDOMETHACIN STERILE PROCESSING FACILITY IN ANAGNI (FROSINONE) ITALY CALCIUM POLYCARBOPHIL PROMETHAZIN HCL. TOLBUTAMIDE USP HYDROCORTISONE-17 VALERATE AS MFG. IN BERLIN (GERMANY) FACILITY BUPIVACAINE HYDROCHLORIDE STERILE PROCESSING FACILITY IN NEW MEXICO METHYLPREDNISOLONE HEMISUCCINATE AS MFG. IN CHICAGO, ILLINOIS FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES POLYETHYLENE FOAM TAPES AS MFG. IN BROOKINGS SOUTH DAKOTA FACILITY IN SOUTH PLAINFIELD, NEW JERSEY PROCYCLIDINE HYDROCHLORIDE USP ALPHA METHYLDOPA USP STATUS Type SUBMIT DATE II 8/29/1985 HOLDER SANKYO CO LTD SUBJECT

4Q2012

CS-514BULK SUBSTANCE PROCESSED TANASHI(TOKYO)& SHINAGAWA(TOKYO)PLANTS

ABBOTT LABORATORIES PHARMACEUTICAL EGG PHOSPHATIDE PRODUCTS DIV SALSBURY CHEMICALS INC FUROSEMIDE USP FOREST LABORATORIES INC DAIICHI FINE CHEMICAL CO LTD BAYER AG HOFFMANN LAROCHE F AND CO LTD LUSOCHIMICA S P A SELOC AG 3M PHARMS BROWNS BOTTLE (CANADA) LTD PURAC BIOCHEM BV DAIICHI FINE CHEMICAL CO LTD THIORIDAZINE HCL. 50MG.C.R.TABLETS SULFADIMETHOXINE AS MFG. IN TOYAMA, JAPAN MAKROFOL KG AS MFG. IN THE DORMAGEN PLANT SITE DECLINAX (DEBRISOQUIN SULFATE) TABS 10MG MFG. IN BASLE, SWITZ CLONIDINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE MEDICAL GRADE ACRYLIC ADHESIVES MANUFACTURED IN CORDOVA, ILLINOIS. PACKAGING MATERIALS ZINC GLUCONATE SODIUM SULFADIMETHOXINE

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4Q2012EXCEL DMF# 6004 6005 I 6006 6007 I 6008 6009 6010 6011 6012 6013 6014 I 6015 6016 6017 6018 6019 6020 6021 6022 6023 I 6024 6025 6026 6027 6028 6029 6030 6031 6032 6033 I 6034 6035 6036 I 6037 6038 6039 I I I II II I 10/4/1985 10/9/1985 10/1/1985 I I II II II 9/23/1985 9/18/1985 10/2/1985 ELI LILLY INDUSTRIES INC BIOCHEMIC GESELLSCHAFT MBH ASTRA CLINICAL RESEARCH ASSOCIATES INC DM GRAHAM LABORATORIES INC SHOWA DENKO KK SMITHKLINE & BECKMAN INC NIZATIDINE MANUFACTURED IN MAYAGUEZ, PR. CEFTAZIDINE-BENZHYDRYLESTER,DIHYDROCHLORIDE FOSCARNET SODIUM INTRAVENOUS SOLUTION IBUPROFEN TIMED-RELEASE 600 MG. TALBETS GYLCINE I I A I A I I I I II I II II II II II II III II 9/16/1985 9/6/1985 9/3/1985 9/23/1985 8/12/1985 9/23/1985 9/17/1985 8/29/1985 9/4/1985 9/11/1985 BOEHRINGER INGELHEIM CHEMICALS INC CHURCH AND DWIGHT CO INC FINE CHEMICALS CORP PTY LTD ILKIM AS GATTEFOSSE SAS ELI LILLY INDUSTRIES INC SOCIETA ITALIANA CORTICOSTEROIDI SPA LAEVOSAN GMBH AND CO KG ALZA CORP I I I I I I I I II II II II II II I III I 8/29/1985 8/30/1985 9/12/1985 9/17/1985 9/23/1985 9/18/1985 8/30/1985 7/29/1985 9/11/1985 I I I A A I II II II II II I II 6/28/1985 9/27/1985 8/30/1985 8/14/1985 9/9/1985 8/30/1985 6/13/1985 EISAI CO LTD PENICK CORP FINORGA SEKISUI MEDICAL CO LTD PCAS 3M PHARMS ORCHIMIE SA (PRODUITS CHIMIQUES ET BIOCHIMIQUES) SIEGFRIED AG FINORGA DAEWOONG CHEMICAL CO LTD SOCIETA ITALIANA CORTICOSTEROIDI SPA ILKIM AS DIOSYNTH BV 3M PHARMS NORTON PERFORMANCE PLASTICS INC WATSON LABORATORIES INC I II II 9/9/1985 7/30/1985 STATUS Type SUBMIT DATE I II II 8/30/1985 8/6/1985 HOLDER FINORGA DAIICHI PURE CHEMICALS COMPANY, LIMITED(JAPAN) AMCIS AG SYNTEX USA INC SUBJECT TOLRESTA MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE.

4Q2012

METHIONINE-ENKEPHALIN AS PRODUCED IN THE FUNABORI FACTORY (TOKYO) TROPICAMIDE MEDROXYPROGESTERONE ACETATE,BULK MFG SYNTEX SA CHEM.DIV(MORELOS)MEXICO MENFEGOL DIDRATE (DIHYDROCODEINE BITARTRATE ANHYDROUS ) 6-METHOXY 5, TRIFLUOROMETHYL 1-NAPHTHOLIC ACID MFG. CHASSE-SUR-RHONE EPSILON-AMINO-N-CAPROIC ACID DESIPRAMINE HCL. FOR BROOKINGS,S.D. CLONIDINE HYDROCHLORIDE VALPROIC ACID & SODIUM VALPROATE METHYL SARCOSINATE HCL AS MFG. IN THE CHASSE-SUR-RHONE(FRANCE)FACILITY TRIMETHOPRIM BETAMETHASONE ASPIRIN USP BETAMETHASONE ACETATE FOR CORDOVA,ILLINOIS PTFE SKIVED TAPE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CORONA, CALIFORNIA. BROMPHENIRAMINE MALEATE FOR THE TAYLORS, SOUTH CAROLINA FACILITY ON NORTH WASON RD FLUPHENAZINE DECANOATE ACETAMINOPHEN USP SUPPOCIRE NIZATIDINE MANUFACTURED IN SHADELAND, IN AND MAYAGUEZ, PR. DEXAMETHASONE HYDROXYETHYL STARCH TRANSDERMAL THERAPEUTIC SYSTEM

FUKUZYU PHARMACEUTICAL COMPANY LTD CHLORPHENIRAMINE MALEATE

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CIDRA, PUERTO RICO. Page

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4Q2012EXCEL DMF# 6040 6041 I 6042 6043 I 6044 6045 I 6046 6047 I 6048 6049 6050 I 6051 6052 I 6053 6054 I 6055 I 6056 6057 I 6058 I 6059 6060 I 6061 I 6062 6063 6064 I 6065 6066 6067 I 6068 I II 9/30/1985 ALDRICH CHEMICAL COMPANY INC A I II II I 10/16/1985 10/8/1985 10/3/1985 PHARMACIA AND UPJOHN SUB PFIZER INC SCIENTIFIC POLYMER PRODUCTS INC GLATT AIR TECHNIQUES INC I I II II I 9/25/1985 9/30/1985 10/17/1985 I 9/19/1985 ORTHO DIAGNOSTIC SYSTEMS DIV ORTHO PHARMACEUTICAL LTD NIPPON KAYAKU COMPANY LTD BASF PLC HALDANE CONSULTANTS LTD I III I 10/1/1985 10/11/1985 II 8/16/1985 I I II 10/2/1985 9/5/1985 II 9/24/1985 I II I 10/2/1985 10/11/1985 I IV II 10/7/1985 10/7/1985 PHARMACIA AB FUJISAWA PHARMACEUTICAL COMPANY LTD ASAHI CHEM INDUSTRY CO LTD CHELSEA LABORATORIES INC I I II II I 9/27/1985 5/31/1985 10/7/1985 NIPPON KAYAKU COMPANY LTD CARLSBERG BIOTECHNOLOGY LTD BIOCHEMIC GESELLSCHAFT MBH I II I 10/7/1985 9/26/1985 GEDEON RICHTER GIULIANI SPA A II I 10/1/1985 9/30/1985 BOEHRINGER INGELHEIM CHEMICALS INC SMITHKLINE & BECKMAN INC I II I 9/16/1985 7/10/1985 BACHEM FINE CHEMICALS INC PHARMACIA AB STATUS Type SUBMIT DATE I III I 9/27/1985 5/31/1985 HOLDER ISRAEL CAN COMPANY LTD CARLSBERG BIOTECHNOLOGY LTD SUBJECT PROD.FLEXIBLE PKG.MATERIAL (KFAR SABA PLANT) MANUFACTURING SITE, FACILITIES, PERSONNEL,AND GENERAL OPERATING PROCEDURES IN COPENHAGEN, DENMARK. ARIAL NARIURETIC PEPTIDE (4-28).HUMAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN UPPSALA, SWEDEN. GLYCOPYRROLATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CIDRA, PUERTO RICO. RGH-4417 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CERNUSCO SUL NAVIGLIO. SUCRALFATE NAFARELIN ACETATE AS MFG. IN THE COPENHAGEN, DENMARK FACILITY

4Q2012

MANUFACTURING SITE, FACILITY, PERSONNEL AND GENERAL OPERATING PROCEDURES IN KUNDL, AUSTRIA SEPHAROSE GEL FILTRATION MEDIA AS MFG IN THE BOLANDERNA FACILITIES NILVADIPINE (FK 235,FR 34235) EGG PHOSPHATIDYLCHOLINE

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LAKEVIEW, NEW YORK. ABBOTT LABORATORIES PHARMACEUTICAL HYDROCHLOROTHIAZIDE PRODUCTS DIV INTERPHARM INC FOR PLAINVIEW,N.Y. SHANGHAI NO 6 PHARMACEUTICAL FACTORY MITSUBISHI YUKA FINE CHEMICALS COMPANY LTD COMAR INC PHARMACIA AB SUCRALFATE ZPT SLURRY GLASS PACKAGING MATERIALS AS MFG IN VINELAND, NJ MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF LARGE VOLUME PARENTERALS IN GLASS BOTTLES IN UPPSALA, SWEDEN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DON MILLS, ONTARIO. AMINO ACID BTS 54 524 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN POOLE, DORSET (ENGLAND), NUFFIELD ROAD. EPOPROSTENOL SODIUM (U-53,217A) POLY (2-HYDROXYETHYL METHACAYLATE) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RAMSEY, NEW JERSEY. 4-METHYLPYAZOLE

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4Q2012EXCEL DMF# 6069 I 6070 6071 6072 6073 I 6074 6075 I 6076 6077 6078 I 6079 6080 I 6081 6082 6083 I 6084 I 6085 I 6086 6087 I 6088 6089 6090 6091 I 6092 6093 6094 6095 6096 I 6097 I 6098 6099 A I II II 10/23/1985 11/19/1985 ANDARD-MOUNT INTERNATIONAL LTD JOHNSON MATTHEY PHARMACEUTICAL MATERIALS I 10/18/1985 DVB ASSOCIATES I I I A II III III II I 11/13/1985 10/9/1985 8/30/1985 11/1/1985 11/22/1985 ORGAMOL SA WEST PHARMACEUTICAL SERVICES, INC. YOKO BUSSAN COMPANY LTD SIEGFRIED LTD SMITHKLINE & BECKMAN INC I I I I II II I 11/8/1985 11/13/1985 11/12/1985 11/7/1985 MATRIX RESEARCH LABORATORIES INC MIKART INC ELI LILLY INDUSTRIES INC OTSUKA PHARM CO LTD I II I 10/25/1985 10/29/1985 I 11/7/1985 II 11/4/1985 I A II II I 9/26/1985 11/6/1985 11/4/1985 I II II 10/21/1985 8/6/1985 JANSSEN PHARMACEUTICA NV HANGZHOU MINSHENG PHARMACEUTICAL FACTORY ALTANA LOMBERG CHEMISCHE FABRIK APTALIS PHARMATECH INC I A I IV I 9/27/1985 10/15/1985 9/30/1985 A IV II 10/18/1985 7/2/1985 I I I II II II I 10/21/1985 10/7/1985 6/18/1985 9/11/1985 BOEHRINGER INGELHEIM CHEMICALS INC GEDEON RICHTER KONOSHIMA CHEMICAL COMPANY LTD STATUS Type SUBMIT DATE I 10/11/1985 HOLDER BIOMED LABORATORIES SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SAN DIMAS, CALIFORNIA. METOCLOPRAMIDE DIAZEPAM USP MAGNESIUM OXIDE

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BEECHAM LABORATORIES DIV OF BEECHAM BLOW MOLDING FACILITY IN BRISTOL,TN. INC COMPANIA ESPANOLA DE SINTESIS BECLOMETHASONE DIPROPIONATE USP QUIMICA SA OTSUKA PHARM CO LTD MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TOKUSHIMA, JAPAN. RHONE-POULENC SPIRAMYCIN BASE VICKS INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CAYEY, PUERTO RICO. AL-721 ACETAMINOPHEN & CODEINE PHOSPHATE TABS. 650/60 CEPHALEXIN HYDROCHLORIDE,BULK MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TOKUSHIMA, JAPAN. TRILOSTANE PLASTIC INJECTION MOLDED CLOSURES O-RING SEAL MATERIALS ACETYLCHOLINE CHLORIDE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CAROLINA, PUERTO RICO. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BETHLEHEM, PENNSYLVANIA. FLUOROURACIL EDROPHONIUM CHLORIDE,BULK

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4Q2012EXCEL DMF# 6100 I 6101 I 6102 6103 6104 6105 6106 6107 6108 6109 I 6110 6111 I 6112 6113 6114 6115 I 6116 6117 I 6118 6119 6120 I 6121 6122 6123 I 6124 6125 6126 6127 I 6128 I 6129 6130 A 6131 I I 11/15/1985 IPEC INTERNATIONAL PACKAGING & EQUIPMENT CORP I IV III 12/16/1985 8/20/1985 II 11/20/1985 YUNG ZIP CHEMICAL INDUSTRY COMPANY LTD LA DREYFUS CO REXAM CLOSURE SYSTEMS INC I I I II II II I 1/8/1986 11/29/1985 12/16/1985 7/29/1985 I I II II II 12/10/1985 12/12/1985 11/25/1985 GANES CHEMICALS INC BEN VENUE LABORATORIES INC AMERSHAM INTERNATIONAL PLC AMERSHAM LABORATORY NIPPON KAYAKU COMPANY LTD ELAN CORP PLC CHEMISCHE FABRIK WEYL GMBH HELOPHARM KG, ARZNEIMITTELFABRIK A I II II I 12/12/1985 11/27/1985 12/11/1985 I II II 11/25/1985 12/10/1985 HOUBA INC I I A IV II II I 12/4/1985 12/3/1985 12/2/1985 11/27/1985 I II I 11/20/1985 10/28/1985 I I I I I I A II I II II II II II II 11/14/1985 9/26/1985 11/20/1985 10/28/1985 10/17/1985 9/25/1985 10/11/1985 11/22/1985 MTM CHEMICALS INC ROUSSEL-UCLAF SOCIETA ITALIANA CORTICOSTEROIDI SPA SUNIL SYNCHEM LD JANSSEN PHARMACEUTICA NV ACE JAPAN CO LTD I 11/15/1985 CHEMISCHE FABRIK WEYL GMBH STATUS Type SUBMIT DATE I 11/25/1985 HOLDER SMITHKLINE & BECKMAN INC SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CAROLINA, PUERTO RICO. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEURES IN MANNHEIM 31, GERMANY. PROPRANOLOL HYDROCHLORIDE,BULK ESBIOL TRIAMCINOLONE L-METHYL DOPA

4Q2012

SMITHKLINE BEECHAM PHARMACEUTICALS ALBENDAZOLE

CARNIDAZOLE-MFG BEERSE & GEEL IN BELGIUM (12.10.86 DSENT TO VET MED SUCRALFATE (SUCROSE SULFATE ALUMINUM SALT) AS MFG. IN JAPAN

ABBOTT LABORATORIES PHARMACEUTICAL PROPOXYPHENE HCL.& PROPOXYPHENE NAPSYLATE PRODUCTS DIV SMITHKLINE BEECHAM PHARMACEUTICALS 'ZENTEL' 'TILTAB' TABLETS GELMAN SCIENCES INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. MITSUBISHI CHEMICAL INDUSTRIES LIMITED SUCROSE MONOPALMITATE AS MANUF IN YOKKAICHI PLANT CHEMIE LINZ AG BOEHRINGER INGELHEIM CHEMICALS INC TUCKAHOE PLASTIC CONTAINERS CELIPROLOL HCL AS MANUF IN THE LINZ,AUSTRIA FACIL. ON ST.PETER-STRABE DOXAPRAM MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. BETAPRONE (BETAPROPIOLACTONE)

ABBOTT LABORATORIES PHARMACEUTICAL DISULFIRAM PRODUCTS DIV EURAND INC POTASSIUM CHLORIDE, MICROENCAPSULATED OMNICHEM NV (PRB) VEGA BIOTECHNOLOGIES INC DESERPIDINE AS PRODUCED IN LOUVAIN-LA-NEUVE PILOT PLANT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TUCSON, ARIZONA. THIORIDAZINE HYDROCHLORIDE METHOTREXATE SODIUM FOR INJECTION, LYOPHILIZED CERETEC TC HMPAO L-~-METHYLDOPA QUINIDINE SULFATE SUSTAINED ACTION PELLETS 1-(METHYLAMINOMETHYL)- NAPHTHALENE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. CLONIDINE HYDROCHLORIDE CHEWING GUM BASES (PD SERIES) VIALS, CLOSURES, OVALS AND SPECIALTY ITEMS FOR THE Rx INDUSTRIES MANUFACTURED AT BERLIN, OH MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURS

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4Q2012EXCEL DMF# 6132 6133 I 6134 6135 I 6136 6137 6138 6139 6140 6141 I 6142 6143 I 6144 6145 6146 I 6147 I 6148 6149 I 6150 6151 A 6152 A 6153 6154 6155 6156 I 6157 6158 6159 6160 6161 6162 6163 6164 I I A I I I I I II II II II II II II II 12/19/1985 12/19/1985 12/30/1985 12/26/1985 11/4/1985 1/13/1986 11/21/1985 10/3/1985 MAY AND BAKER LTD FREEDOM CHEMICAL DIAMALT GMBH CAMBREX PROFARMACO MILANO SRL SIGMA F AND D DIV LTD EVANS MEDICAL LTD WYETH AYERST LABORATORIES INC ETHYL CORP BIOCON BIOCHEMICALS, LIMITED I I I II II II I 1/2/1986 12/17/1985 12/20/1985 1/13/1986 II 2/15/1983 I II III 1/7/1986 11/11/1985 DSM ANDENO GEORGIA GULF CHEMICALS AND VINYLS LLC BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG SIGMA F AND D DIV LTD ALDRICH CHEMICAL COMPANY INC MALLINCKRODT CHEMICAL INC WYETH AYERST LABORATORIES INC A II III 12/23/1985 12/6/1985 SIGMA ALDRICH MANUFACTURING LLC ADVANCED ELASTOMER SYSTEMS I 1/13/1986 S-P PRODUCTS INC I I II II III 11/1/1985 12/9/1985 1/2/1986 I II II 12/23/1985 1/4/1985 TAKEDA CHEMICAL INDUSTRIES LTD LABORATORIO CHIMICO INTERNATIONAL SPA LONZA INC ELAN CORP PLC ELI LILLY INDUSTRIES INC I I I I I II II II II II I 12/20/1985 12/23/1985 12/9/1985 12/20/1985 12/20/1985 12/21/1985 I II II 12/16/1985 12/17/1985 STATUS Type SUBMIT DATE I II III 12/18/1985 11/8/1984 HOLDER LEE LABS INC BORDEN PACKAGING AND INDUSTRIAL PRODUCTS GANES CHEMICALS INC SYNTEX LABORATORIES INC SUB SYNTEX CORP MALLINCKRODT CHEMICAL INC ROUSSEL-UCLAF HOECHST AG ELAN CORP PLC FARCHEMIA FARMABOIS SUBJECT LENPERONE FILM FORMULATIONS,TERMOVIR R FLIM TOLRESTA AS MFG.ON CUSTOM BASIS INVESTIGATIONAL DRUG SUBSTANCE,RS-82917-030 PROPOXYPHENE NAPSYLATE 16 - MEYHYLPERDNISONE 21-PROPIONATE PENICILLIN G SODIUM (BULK) PN-200-LA TABLETS AND PLACEBO TABLETS METHYLDOPA

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GROPELLO CAIROLI, ITALY. TAP-144-SR INJECTION (EXTENDED-RELEASE FORM OF LEUPROLIDE ACETATE) SALBUTAMOL BASE AND SALBUTAMOL SULFATE (ALBUTEROL BASE ETC.) TOLRESTA AND ITS INTERMEDIATES PARACETAMOL (ACETOMINOPHEN) ORAL LA SUSPENSION QUALITY CONTROL PROCEDURES FOR IN-COMING INSPECTION OF PACKAGING COMPONENTS USED IN PUERTO RICO MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES S-P PRODUCTS, INC. TRIPALMITIN SANTOPRENE THERMOPLASTIC ELASTOMER GRADE 271-64-W144 AS MFG FOR ADVANCED ELASTOMER SYSTEMS BY PLASTICOLORS, INC., ASHTABULA, OHIO. SILVER SULFADIAZINE POLYVINYL CHLORIDE PRODUCTS SCOPOLAMINE HYDROBROMIDE AS MFG. IN THE INGELHEIM AM RHEIN FACILITY NALOXONE HCL.AS RELABELLED FOR SIGMA TERT-BUTYL METHYL ETHER PROPOXYPHENE HYDROCHLORIDE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ENGLAND. PROMAZINE HYDROCHLORIDE URSODEOXYCHOLIC ACID CHLORDIAZEPOXIDE BASE POLYETHYLENE GLYCOL DIAMOPHINE HYDROCHLORIDE TEMAZEPAM TOLRESTA MANUF IN ORANGEBURG,S.C FACIL. ON CANNON BRIDGE ROAD SODIUM HEPARIN AS MANUFACTURED IN THE KILNAGLEARY CARRIGALINE FACILITY

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4Q2012

KB-2413,1-(2-ETHOXYETHYL)-2-(4-METHYL-I-HOMOPIPERAZINYL)BENZIMIDAZOLE-

MATERIALS PROCESSING TECHNOLOGY INC ACETAMINOPHEN,73% GRANULATION

ACETOHYDROXAMIC ACID AS MFG BY ISOCHEM S.A. IN GENNEVILLIERS, FRANCE N-[,3-5-DI(PYROLIDNYLMETHYL)-4-HYDROXY]BENZOYL ANILINE(A.CC.-9358) MUZOLIMINE SEMIHYDRATE RITODRINE HCL AS MFG. IN ESPOO, FINLAND GESTODENE (ESUB) AS MANUF IN THE BERLIN FACILS. ON MULLERSTRABE LEVONORGESTREL INTRAUTERINE DEVICE-MANUF IN TURKU,FINLAND FACILS. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HOLYWELL, WALES, UNITED KINGDOM. POLYETHYLENE TEREPHTHALATE (PET) BOTTLES TRIPROLIDINE HCL. 1-METHYL AMINO-1-METHYL-THIO-2-NITROETHYLENE AND MFG BY ISOCHEM S.A. MANUFACTURE AND ASSEMBLY FACILITIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HOBBESDON, HERFORDSHIRE, ENGLAND. CAFFEINE PRAZOSIN HYDROCHLORIDE THEOPHYLLINE PHARMAZOME TM POWDER HYDROCORTISONE HEMISUCCINATE AS MFG. IN MILAN, ITALY N-ACETYLPROCAINAMIDE HCL. SULINDAC AS MFG. IN VICENZA, ITALY

ABBOTT LABORATORIES PHARMACEUTICAL ETHRANE (ENFLURANE)-MFG BY ABBOTT S.P.A.-CAMPOVERDE DI APRILIA (ITALY) PRODUCTS DIV ORION CORPORATION FERMION OULU BENZTROPINE MESYLATE PLANT ELAN CORP PLC IBUPROFEN CAPSULES DINAMITE DIPHARMA SPA ZAMBON SPA GANES CHEMICALS INC SIGMA F AND D DIV LTD PACKAGING COORDINATORS INC CP PHIBROCHEM DIV PHILIPP BROTHERS CHEMICALS INC TEVA PHARMACEUTICAL INDUSTRIES LTD KOTHARI PHYTOCHEMICALS INTERNATIONAL SAN FU CHEMICAL COMPANY LTD D-OXYPHENE AS MFG. IN THE MILANO (ITALY) FACILITIES THIAMPHENICOL AS MFG. IN THE ALMISANO DI LONIGO(VICENZA)ITALY FACILITY EPHEDRINE HYDROCHLORIDE DELTA-AMINOLEVULINIC ACID HCL AS MFG IN THE ST. LOUIS, MO. FACILITY PCI CARIBE,INC.FACILITY,GURABO,PUERTO RICO GUAIFENSEIN USP AS MFG. IN TAIWAN NIFEDIPINE MANUFACTURED IN MILANO, ITALY. CHLORPROPAMIDE AND TOLBUTAMIDE AS MFG.IN THE NAGARI,THANICHCHIYAM FAC. MANNITOL AS MFG. IN THE TAICHUNG CITY (INDUSTRIAL ZONE) FACILITY

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4Q2012EXCEL DMF# 6200 I 6201 6202 6203 6204 6205 6206 6207 6208 6209 6210 6211 I 6212 I 6213 6214 6215 6216 6217 A 6218 6219 6220 6221 6222 6223 6224 6225 6226 6227 6228 6229 I 6230 6231 6232 6233 6234 6235 6236 N A A I I I I II III II I IV IV 3/11/1986 10/7/1985 2/17/1986 3/3/1986 12/17/1985 2/28/1986 NOT AN ASSIGNED NUMBER SIEGFRIED USA LLC KEY INTERNATIONAL INC QUATRUM ZEELAND CHEMICALS INC PRODUCERS COTTON OIL CO HETERENE CHEMICAL COMPANY INC METHADONE HYDROCHLORIDE AS MFG IN THE PENNSVILLE, NJ FACILITY I I I I I I I I I I I III III II II II II II II II II III IV 3/12/1986 2/11/1986 3/7/1986 2/17/1986 2/20/1986 12/16/1985 2/27/1986 2/20/1986 9/6/1985 2/26/1986 12/4/1985 2/18/1986 A I A A II III II II II 3/5/1986 3/4/1986 1/23/1986 2/20/1986 2/25/1986 TEVA PHARMACEUTICAL INDUSTRIES LTD MID-STATE PLASTICS, INC. ASAHI KASEI FINECHEM CO LTD SIGMA ALDRICH MANUFACTURING LLC JOHNSON MATTHEY PHARMACEUTICAL MATERIALS REXAM MEDICAL PACKAGING INC PALMYRA NONWOVENS CORP EASTMAN KODAK CO CHEMWERTH BALENCO ENTERPRISES INC FABBRICA ITALIANA SINTETICI FINE CHEMICALS CORPORATION BIOTEK INC PFIZER LABORATORIES DIV PFIZER INC ROUSSEL-UCLAF DUPONT POLYESTER BRASKAP INDUSTRIA E COMERCIO LTDA I 2/7/1986 STERIS LABORATORIES INC I I I I I I I I I I II III I II III II II II II II I 2/11/1986 2/22/1986 11/12/1985 1/10/1986 2/17/1986 2/21/1986 2/21/1986 1/16/1986 12/9/1985 3/4/1986 3/3/1986 STATUS Type SUBMIT DATE II 2/12/1986 HOLDER SUBJECT ABBOTT LABORATORIES PHARMACEUTICAL HALOPERIDOL AS MFG IN THE NORTH CHICAGO, IL FACILITY PRODUCTS DIV SIGMA F AND D DIV LTD DEOXYCHOLIC ACID,SODIUM SALT BEMIS CO INC BERKELEY ANTIBODY CO GEDEON RICHTER B BRAUN MEDICAL INC BRACCO IND CHIMICA SPA MIKART INC CHINOIN PHARM & CHEM WORKS LTD BIOCON BIOCHEMICALS LTD ELAN CORP PLC R P SCHERER LTD PRODUCTION OF DRUG PACKAGING MATERIALS IN MURPHUSBORO, IL IMMUNOLOGICAL SERVICES AS RELATED TO VITRO QUALITY ASSURANCE

4Q2012

DISOPYRAMIDE PHOSPHATE CAPSULES MFG. BY CHEMICAL WORKS OF ABOVE MCGAW TM PLASTIC CONTAINER IOTHALAMIC ACID AS MFG IN THE MILANO, ITALY FACILITY ACETAMINOPHEN AND HYDROCODONE BITARTRATE VERAPAMIL HYDROCHLORIDE AS MFG. IN BUDAPEST, HUNGARY PAPAIN AS MFG. IN THE COUNTY CORK, IRELAND FACILITY IBUPROFEN 300MG. LA CAPSULES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WEST BETHANY, ARIZONA. ATENOLOL MANUFACTURED IN MILANO, ITALY. INJECTION MOLDED PARTS IN SEAGROVE, NORTH CAROLINA CYTARABINE AS MFG IN THE PHARMACEUTICAL PLANT IN NOBEOKA-SHI, JAPAN PALMITIC ACID AS RELABELLED FOR SIGMA F AND D DIVISION, LTD, MO FENTANYL BASE AS MFG IN THE WEST CHESTER, PENN FACILITY ON KNG ROAD HEAT SEALABLE AND PEELABLE ADHESIVE COATINGS AS MFG IN WISCONSIN FIBROUS RAYON PHARMACEUTICAL COILS AS MFG IN PALMYRA, NY FACILITY MEROCYANINE 540 AS MFG BY THE SYNTHETIC CHEMICAL DIV IN ROCHESTER VINCRISTINE SULFATE AS MFG. IN YUHANGTANG, HANGZHOU DECYLMETHYL SULFOXIDE USP AS MFG. IN COMPTON, CALIFORNIA TRIMETHOPRIM AF (ANILINE FREE) AS MFG IN ALTE DE MONTECCHIO MAGGIORE MECLOFENAMATE SODIUM AS MFG IN THE EPPING (CAPE PROVINCE) SOUTH AFRICA LEVONORGESTREL MICROCAPSULES AS MFG IN THE WOBURN, MASS FACILITY TINIDAZOLE AS MFG BY PFIZER CHEMICAL CORP IN RINGASKIDDY, IRELAND DISOPYRAMIDE PHOSPHATE AS MFG. IN MILAN, ITALY CARODEL POLYETHYLENE TEREPHTHALATE (PET) RESINS X5122 EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN THE SOROBACA - SP - BRAZIL FACILITY

POLYVINYLCHLORIDE/POLYETHYLENE THERMOPLASTIC FILM AS MFG IN ITALY DEXAMETHASONE BASE BP/KUSP AS MGF IN THE SACAVEM, PORTUGAL FACILITY FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES SAFFLOWER OIL AS PROCESSED IN THE FRESNO, CA FACILITY ETHYLENE OXIDE ADDUCTS OF NONYL PHENOL AS MFG IN PATERSON, NJ FACILITY

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4Q2012EXCEL DMF# 6237 6238 6239 6240 6241 6242 I 6243 6244 6245 I 6246 6247 6248 6249 6250 6251 6252 6253 I 6254 6255 I 6256 I 6257 6258 6259 I 6260 6261 6262 6263 6264 6265 6266 6267 6268 6269 I 6270 6271 6272 I I I III II II 3/28/1986 4/15/1986 4/14/1986 DEERFIELD SPECIALTY PAPER INC ELAN CORP PLC ZEELAND CHEMICALS INC I I I I I A I C I II II II II II II II II II I 4/4/1986 4/10/1986 4/9/1986 4/11/1986 4/14/1986 4/11/1986 4/11/1986 4/14/1986 4/14/1986 3/24/1986 I A I II I 4/8/1986 3/27/1986 3/6/1986 RETAIL DRUG INSTITUTE PHARMACIA AND UPJOHN SUB PFIZER INC RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA SIGMA F AND D DIV LTD SOCIETA ITALIANA CORTICOSTEROIDI SPA AWARD CORP PFANSTIEHL LABORATORIES INC OY STAR AB MALLINCKRODT INC RHONE POULENC ATABAY KIMYA SANAYI VE TICARET AS ATABAY KIMYA SANAYI VE TICARET AS PMC PUERTO RICO INC I 4/2/1986 TRINITY TECHNOLOGIES CORP I II I 4/1/1986 4/8/1986 HOVIONE SOCIEDADE QUIMICA LDA HOECHST MARION ROUSSEL SA I A A I I I A II II III IV II II IV I 3/26/1986 4/4/1986 3/31/1986 3/26/1986 4/3/1986 4/4/1986 4/4/1986 1/13/1986 I A II IV II 3/19/1986 4/3/1986 4/9/1986 STATUS Type SUBMIT DATE I I I I I II II II II I II 6/10/1985 11/11/1985 3/4/1986 3/16/1986 3/11/1986 3/3/1986 HOLDER UNICHEM LABORATORIES LTD PHARM ECO LABORATORIES INC MEDICHEM SA BACHEM FINE CHEMICALS INC LIQUIPHARM INC SYNTEX LABORATORIES INC SUB SYNTEX CORP ORION CORP LTD ROQUETTE FRERES HARTINGTON CHEMICALS DIV STAVELEY CHEMICALS LTD SIEGFRIED AG FERMION OY FUJIMORI KOGYO CO LTD SHIONOGI QUALICAPS INC LYPHOMED INC NIPPON FINE CHEMICAL COMPANY LTD NIPPON FINE CHEMICAL CO LTD VICTOR INDUSTRIES SUBJECT HYDROCHLOROTHIAZIDE B.P. AS MFG IN BOMBAY, INDIA FACILITY D-TUBOCURARINE AS MGF IN THE SIMI VALLEY, CA FACILITY ON CHAIN DRIVE METOCLOPRAMIDE HYDROCHLORIDE MANUFACTURED IN CELRA, SPAIN. CORTICOTROPIN RELEASING FACTORS (CRF), (HUMAN, RA) LIQUID AND TOPICAL PRODUCTS FOR HUMAN USE RS-82856-130 CHLORHEXIDINE DIHYDROCHLORIDE BP 80 POLYSORB 85/70/00 (SORBITOL SORBITAN SOLUTION) ACETAMINOPHEN USP AS MFG. IN THE UNITED KINGDOM NIFEDIPINE NADOLOL AS MFG. IN FINLAND PLASTIC FILM EMPTY GELATIN CAPSULES STERILE CEFTIZOXIME SODIUM USP PHOSPHOLIPID DPPC PHOSPHOLIPID-DSPC AS MFG. IN HYOGO, JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NEWPORT, AK. BECLOMETHASONE 17,21-DIPROPIONATE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN COMPIEGNE. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN STERLING HEIGHTS. AEROSOLS PRODUCED AT LONG ISLAND UNIVERSITY ESTRAMUSTINE PHOSPHATE SODIUM AS MFG. IN COUNTY CORK,IRELAND CHEMICAL FACTORY IN CAMPOVERDE DI APRILIA L-SERINE - (S 4500 FD METHYLPREDNISOLONE AS MANUF IN MILAN,ITALY PHENYLPROPANOLAMINE HCL USP XXI. FLESTOLOL SULFATE RITODRINE HCL NALTREXONE HCL (ESUB) AS MANUFACTURED IN ST LOUIS MO IGEPAL CA-630G (OCTOXYNOL 9) AS MFG. IN LINDEN, NEW JERSEY ACETAMINOPHEN ASPIRIN 100% (U.S.P.). MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PUERTO RICO. CAP LINER PAPER POTASSIUM CHL SUSPENSION OXYBUTYNIN CHLORIDE

4Q2012

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4Q2012EXCEL DMF# 6273 6274 I 6275 6276 I 6277 6278 6279 6280 6281 6282 6283 6284 6285 6286 6287 6288 6289 6290 6291 6292 6293 A 6294 6295 6296 6297 6298 6299 6300 6301 6302 6303 6304 6305 6306 I 6307 6308 6309 6310 I I A I I I II II 4/25/1986 4/30/1986 5/5/1986 3/11/1986 I I I I I I I I I I I I II II II III II II III II II II II II I 4/23/1986 4/18/1986 4/4/1986 4/23/1986 4/23/1986 4/18/1986 4/22/1986 4/23/1986 3/5/1986 4/28/1986 4/24/1986 4/28/1986 4/28/1986 A I I I I I I I I A I I A I A N V 4/24/1986 II II II II II III II II I II II II II II II 4/1/1986 4/16/1986 4/21/1986 4/1/1986 3/27/1986 3/25/1986 3/28/1986 3/27/1986 3/4/1986 3/4/1986 3/17/1986 12/13/1985 4/23/1986 4/21/1986 4/25/1986 I II II 4/21/1986 4/22/1986 FARCHEMIA STATUS Type SUBMIT DATE I III I 4/18/1986 3/28/1986 HOLDER ERIE PLASTICS CENTURY PLASTICS INC SUBJECT PACKAGING MATERIALS AS MFG. IN CORRY, PENNSYLVANIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN EL DORADO, KANSAS. TINIDAZOLE USP XXI

4Q2012

FARMSON PHARMACEUTICAL GUJARAT PVT ACETAMINOPHEN LTD FERRO PFANSTIEHL 1-B-D-ARABINOFURANOSYL CYTOSINE (CYTARABINE) AS MFG. IN IL. ERREGIERRE SPA SANOFI SYNTHELABO INC. ZEELAND CHEMICALS INC HOECHST MARION ROUSSEL SA ALLIANCE TOOL CORP SIGMA F AND D DIV LTD CHEMISCHE FABRIK WEYL GMBH SYNTHELABO PHARMACIE FINORGA SAS HOVIONE SOCIEDADE QUIMICA LDA RHONE POULENC RORER INC CU CHEMIE UETIKON GMBH SAPCOL INTERNATIONAL LTD BACHEM AG NOT AN ASSIGNED NUMBER MULTIDISCIPLINARY ASSN PSYCHEDELIC STUDIES ABBOTT LABORATORIES HEINRICH MACK NACHF SIGMA F AND D DIV LTD CHEMICAL FABRICS CORP SIGMA F AND D DIV LTD SIGMA F AND D DIV LTD TIROS PLASTICS CANADA DIOSYNTH BV UNITIKA RAYON LTD FARMOS GROUP LTD MEDIPOLAR PHARM ECO LABORATORIES INC HEXAGON LABORATORIES INC NORTH AMERICAN SCIENCE ASSOCIATES INC DAIWA PHARMACEUTICAL CO LTD CP PHARMACEUTICALS LTD FINE CHEMICALS CORP PTY LTD PLANTEX LTD CHEM AND PHARM WORKS MDMA (3,4-METHYLENEDIOXYMETHAMPHETAMINE) IN RATS AND DOGS ETHRANE (ENFLURANE) AS MFG. IN QUEENBOROUGH, KENT, ENGLAND M-AMSA AS MFG. IN THE FEDERAL REPUBLIC OF GERMANY TRYPSIN INHIBITOR,-T AND ALPHA-CHYMOTRYPS FLUOROPOLYMER FILMS TRYPSIN TYPE III, BOVINE APROTININ, BOVINE LUNG PLASTIC PACKAGING COMPONENTS AS MFG. A ONTARIO,CANADA FAC. CODEINE PHOSPHATE AS MFG. A THE OSS, HOLLAND FACILITY MICROCRYSTALLINE CELLULOSE AS MFG. A KYOTO-FU, JAPAN NIFEDIPINE AS MFG IN FINLAND VINCRISTINE SULPHATE AS MFG. IN SIMI VALLEY, CALIFORNIA CHLORPHENIRAMINE MELEATE USP FACILITIES, PERSONNEL AND OPERATING PROCEDURES AT IRVINE, CA. CLONIDINE HYDROCHLORIDE AS MFG IN TOYMA CITY, JAPAN FACILITY AT WREXHAM, WALES THIOTHIXENE AS MFG IN CAPE PROVINCE, SOUTH AFRICA DISOPYRAMIDE PHOSPHATE USP AS MFG. IN TEL AVIV METOPROLOL TARTRATE USP NALBUPHINE HYDROCHLORIDE AS MFG. IN ARAMON, FRANCE FACILITY PHENYLPROPANOLAMINE HYDROCHLORIDE AS MFG. IN ZEELAND, MI. TRIAMCINOLONE USP AS MFG. IN FRANCE INJECTION MOLDED PARTS MANUFACTURED IN ROCHESTER, NEW YORK. BETA-AMINOPROPIONITRILE MONOFUMARARTE SALT AS MFG.IN ST.LOUIS ZINK PYRION PLATELETS AS MFG. IN GERMANY FACILITY A MOURENX, FRANCE BETAXOLOL HYDROCHLORIDE AS MFG.ATMOURENX, FRANCE FACILITY DANAZOL AS MFG. IN LISBON, PORTUGAL PENTAMIDINE ISETHIONATE AS MFG. IN ENGLAND METHIMAZOLE AS MFG. IN LAHR, GERMANY VINCRISTINE AS MFG IN PAKISTAN DECAPEPTYL AS MFG BUBENDORF/SWITZERLAND

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4Q2012EXCEL DMF# 6311 I 6312 6313 6314 6315 6316 I 6317 6318 6319 6320 6321 I 6322 I 6323 I 6324 6325 6326 6327 6328 I 6329 6330 6331 6332 I 6333 I 6334 6335 I 6336 6337 I 6338 6339 6340 I 6341 6342 6343 I I I II I II 2/4/1986 5/14/1986 5/14/1986 I A III II II 5/30/1986 3/14/1986 2/10/1986 VALSPAR CORP ZACH SYSTEM SPA COMPANIA ESPANOLA DE SINTESIS QUIMICA SA UNIV OF MISSOURI RESEARCH REACTOR CHANTAL PHARMACEUTICAL CORP CHANTAL PHARMACEUTICAL CORP 550 X 352 EPOXY-UREA BASE COATING MANUFACTURED IN ILLINIOS. NIFEDIPINE USP AS MFG. IN THE VICENZA, ITALY FACILITY MEDROXY PROGESTERONE ACETATE AS MFG IN SEGOVIA, SPAIN I II II 10/25/1985 1/20/1986 UNICHEM LABORATORIES LTD CLOMIPHENE CITRATE AS MFG. IN BOMBAY, INDIA MATERIALS PROCESSING TECHNOLOGY INC ACETAMINOPHEN 90% AS MFG. IN THE PATERSON,NEW JERSEY,FACILITY I II II 1/9/1986 3/21/1986 AWARD CORP I 3/31/1986 EMERY CHEMICALS I I I I II II I 2/14/1986 5/9/1986 10/25/1985 9/3/1985 A I I I II II III II II 3/1/1986 3/1/1986 4/30/1986 5/8/1986 2/20/1986 II 2/5/1986 II 2/5/1986 A A I I II II III II II 5/6/1986 3/4/1986 3/18/1986 3/18/1986 2/5/1986 I I I A II II II II I 3/19/1986 3/13/1986 3/3/1986 3/10/1986 2/5/1986 KV PHARMACEUTICALS CO ELAN CORP PLC CILAG CHEMIE AG NYCOMED AUSTRA GMBH INTERMEDI CHIMICI SINTETICI SPA ZONA INDUSTRIALE MEDICHEM SA NORAMCO INC EI DUPONT DE NEMOURS AND CO VELSICOL CHEMICAL CORP INTERMEDI CHIMICI SINTETICI SPA ZONA INDUSTRIALE INTERMEDI CHIMICI SINTETICI SPA ZONA INDUSTRIALE INTERMEDI CHIMICI SINTETICI SPA ZONA INDUSTRIALE ERREGIERRE SPA ERREGIERRE SPA CENTURY PLASTICS INC ELAN CORP PLC YAMAMOTO CHEMICAL INDUSTRIES COMPANY LTD ZAPPA PLASTICS INC CUNO INC UNICHEM LABORATORIES LTD PFIZER CANADA INC STATUS Type SUBMIT DATE I 5/5/1986 HOLDER ALMEDICA SERVICES CORP SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WALDRICK, NEW JERSEY. DISOPYRAMIDE S.R. CAPSULES 150 MG. PINDOLOL THYMOPENTIN ACETATE HYDRATE AS MFG. IN SWITZERLAND MIDODRINE HYDROCHLORIDE FACILITIES, PERSONNEL AND OPERATING PROCEDURES DIPYRIDAMOLE AS MFG. IN SPAIN

4Q2012

OXYCODONE HYDROCHLORIDE AS MFG. IN WILMINGTON, DE AND ATHENS, GA ND-G-3681 HEXACHLOROPHENE-GRADE G AS MFG IN THE BEAUMONT,TEXAS FACILITY NIFEDIPINE AS MFG IN LENDINARA, ITALY FACILITIES THIORIDAZINE HYDROCHLORIDE USP AS MFG. IN LENDINARA, ITALY FUROSEMIDE USP AS MFG. IN THE LENDINARA, ITALY FACILITIES CLOTRIMAZOLE MANUFACTURED IN ITALY. ATENOLOL AS MFG. BY THE HOLDER IN ITALY PIPETTE INJECTION MOLDED FOR DORSEY LABS THEOPHYLLINE CONTROLLED RELEASE BEADS MANUFACTURED IN IRELAND. MEFENAMIC ACID AS MFG. IN WAKAYAMA, JAPAN BUILDINGS, FACILITIES, AND PERSONNEL IN GREENBROOK, N.J. MICROFLUOR CARTRIDGES FOR STERILE FILTRATION MANUFACTURED INMERIDEN,CT SUCRALFATE AS MFG. IN THE BOMBAY, INDIA FACILITY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ARNPRIOR, ONTARIO, CANADA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MAULDIN, SOUTH CAROLINA. PHENYLPROPANOLAMINE HYDROCHLORIDE USP AS MFG. IN NEW YORK

LEK PHARMACEUTICAL & CHEMICAL WORKS NIFEDIPINE MANUFACTURED IN MENGES, SLOVENIA

SM-153-ETHYLENEDIAMINETETRAMETHYLENEPHOSPHONIC ACID (SM-153-EDTMP) BUILDINGS AND FACILITIES IN BUBENDORF SWITZERLAND CYOCTOL AS MFG. IN BUBENDORF, SWITZERLAND

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4Q2012EXCEL DMF# 6344 6345 6346 6347 6348 6349 6350 A 6351 6352 6353 6354 I 6355 6356 6357 6358 6359 6360 6361 I 6362 6363 6364 I 6365 I 6366 I 6367 6368 6369 I 6370 6371 6372 6373 6374 6375 6376 I 6377 6378 I I III III 6/2/1986 5/30/1986 I I A I I I II I II II II II II 5/22/1986 5/22/1986 5/16/1986 5/23/1986 5/30/1986 5/27/1986 5/30/1986 I I II II II 5/20/1986 1/16/1986 5/23/1986 II 5/16/1986 I 5/16/1986 A I II II I 10/4/1984 5/16/1986 2/14/1986 UCB MANUFACTURING IRELAND LIMITED SIGNA SA JANSSEN PHARMACEUTICA NV I I I A I I II II II IV II III I 5/15/1986 5/12/1986 5/12/1986 5/16/1986 5/14/1986 5/14/1986 9/30/1985 I I I II I II II 5/29/1986 5/14/1986 5/15/1986 5/15/1986 DAIICHI SANKYO PROPHARMA CO LTD CLASSIC INDUSTRIES INC NOVO NORDISK AS PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA NORAMCO INC UNICHEM LABORATORIES LTD UNICHEM LABORATORIES LTD QUALICAPS CO LTD RHONE-POULENC SANTE CENTURY PLASTICS INC 3M PHARMS STATUS Type SUBMIT DATE A A I I I I III III I II II II III 5/9/1986 2/20/1986 5/28/1986 5/19/1986 5/12/1986 5/5/1986 3/11/1986 HOLDER BAXTER HEALTHCARE CORP FLINT HILLS RESOURCES LP BAYER AG ACF CHEMIEFARMA NV ORGAMOL SA ZAMBON SPA APTAR RADOLFZELL GMBH SUBJECT STERILE SVP INJECTIONS IN SEAL/FILL/SEAL PLASTIC CONTAINERS REXENE POLYPROPYLENE RESINS PP23S2, CS-225, AND PP 23S2A FACILITIES AND PERSONNEL IN LEVERKUSEN, GERMANY SULFAPYRIDINE AS MFG IN THE HOLLAND FACILITY ACETOHEXAMIDE MANUFACTURED IN SWITZERLAND. THIAMPHENICOL GLYCINATE HCL AS MFG IN VICENZA,ITALY MULTIDOSE DISPENSING SYSTEMS AS MANUFACTURED IN RADOLFZELL AND EIGELTINGEN, GERMANY OFLOXACIN BULK DRUG SUBSTANCE AS MFG. IN AKITA, JAPAN CONTROLS, FACILITIES AND PERSONNEL IN LAROBE, PENNSYLVANIA NORETHINDRONE ACETATE AS MFG. IN DENMARK PRAZOSIN HYDROCHLORIDE AS MFG. IN NIMIS (UDINE) ITALY SUPROFEN AS MFG IN AHENS, GEORGIA METRONIDAZOLE BENZOATE AS MFG. IN BOMBAY, INDIA CLONIDINE HYDROCHLORIDE MFG. IN BOMBAY, INDIA EMPTY GELATIN CAPSULES AS MFG. IN YAMATO-KORIYAMA,NARA,JAPAN MEGLUMINE AS MFG. IN CLEON, FRANCE CANNULA ASSEMBLY INJECTION MOLDED FOR DORSEY LABS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF SPUNLACED FABRIC TAPE IN BROOKINGS, SD. ISOSORBIDE 5-NITRATE DILUTED ALPHA METHYL DOPA USP AS MFG. IN MEXICO

4Q2012

MANUFACTURING SITE, PERSONNEL, FACILITIES, AND GENERAL OPERATING PROCEDURES AT GEEL, BELGIUM. CUNO INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES . TEMMLER WERKE VEREINIGTE CHEMISCHE CONTROLLED RELEASE PELLETS OR PACKED CAPSULES CONTAINING SAME FABRIKEN HOECHST MARION ROUSSEL SA TRIAMCINOLONE ACETONIDE MANUFACTURED IN FRANCE INDUSTRIAS QUIMICAS ESTEVE SA BELLAFOLINE SUBSTANCE 60% AS MFG. IN BRAZIL ABBOTT LABORATORIES PHARMACEUTICAL OXYBUTYNIN CHLORIDE PRODUCTS DIV KV PHARMACEUTICAL CO RU-VERT M TABLETS (MECLIZINE HCL) ORGANON INC NORDION CANADA INC FABBRICA ITALIANI SINTETICI SPA BACHEM INC SALSBURY CHEMICALS INC LABORATORY FOR ANALYTICAL BIOLOGY INC DORLYL USINE DU HAVRE NOVA CHEMICALS LTD ORGANIZATION, FACILITIES AND MANUFACTURING FACILITIES IODINE 131 MANUFACTURED IN KANATA, ONTARIO, CANADA. ALLOPURINOL AS MFG. IN ITALY GROWTH HORMONE RELEASING FACTOR (GRF) (1-29) AMIDE, HUMAN CHLORPROPAMIDE, U.S.P. GC-MS FOR QUANTITAIVE DETERMINATION OF CLONIDINE IN PLASMA PVC PRODUCTS AS MFG. AT LE HAVRE CEDEX, FRANCE IMPACT POLYSTYRENE FORMULATIONS AS MFG. IN ONTARIO, CANADA

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4Q2012EXCEL DMF# 6379 6380 6381 6382 6383 6384 I 6385 6386 6387 6388 6389 6390 6391 6392 I 6393 6394 6395 6396 6397 I 6398 6399 6400 I 6401 6402 6403 I 6404 6405 6406 6407 6408 6409 6410 6411 6412 6413 6414 I I I I I A I I A A A II II III II III II IV II II II II 6/2/1986 6/9/1986 6/11/1986 6/15/1982 5/28/1986 6/5/1986 6/10/1986 6/12/1986 6/12/1986 6/6/1986 6/9/1986 HEICO CHEMICALS DIV WHITTAKER CORP PFIZER INC CONSOLIDATED CONTAINER CO TENNECO CHEMICALS INC INTERTECH CORP NV ORGANON JRS PHARMA LP MERCK KGAA PCAS NORAMCO INC RECKITT & COLMAN PRODUCTS LTD PHARMACEUTICAL DIV I I II II II 6/3/1986 6/10/1986 6/2/1986 EASTMAN KODAK CO FINE ORGANICS LTD HEICO CHEMICALS DIV WHITTAKER CORP I I II II I 8/1/1985 6/4/1986 6/5/1986 I I I I II II II II I 6/4/1986 12/17/1982 6/2/1986 6/6/1986 6/9/1986 HYBRITECH INC DINAMITE SPA SIGMA F AND D DIV LTD GANES CHEMICALS INC MEDICAL UNIV OF SOUTH CAROLINA HOSP PHARMACY PHARM ECO LABORATORIES INC PHARM ECO LABORATORIES INC HOFFMANN LAROCHE A I I I I I A II II II II I II II I 5/5/1983 5/15/1986 5/9/1986 2/21/1986 8/6/1985 6/4/1986 5/9/1986 5/30/1986 SANOFI WINTHROP INDUSTRIE ALDRICH CHEMICAL COMPANY INC SALK INSTITUTE NV ORGANON ORION CORP LTD FINE CHEMICALS CORPORATION DIPHARMA FRANCIS SRL PHARMACIA & UPJOHN AB STATUS Type SUBMIT DATE I I I I I II II II II I I 6/17/1986 6/3/1986 6/3/1986 5/27/1986 6/2/1986 5/19/1986 HOLDER STEROID SRL CARRINGTON LABORATORIES INC CARRINGTON LABORATORIES INC CHINOIN PHARM & CHEM WORKS LTD BAYER AG PHARMEXPERT SUBJECT NANDROLONE PHENPROPIONATE USP MANUFACTURED IN MILAN, ITALY. CSN-GEL AS MFG. IN DALLAS, TEXAS CSN BULK PRODUCT ETHAMBUTOL HYDROCHLORIDE AS MFG. BUDAPEST, HUNGARY FACILITIES AND PERSONNEL AT WUPPERTAL, GERMANY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HUNGARY. CORDARONE (AMIODARONE HYDROCHLORIDE) AS MFG.IN AMBARES,FRANCE 3-ISOBUTYL-1-METHYLXANTHINE AS MFG. IN MILWAUKEE, WISCONSIN NAL-GLU ANTAGONIST AS RESEARCHED IN SAN DIEGO, CALIFORNIA NALBUFINE HYDROCHLORIDE AS MFG. IN THE NETHERLANDS METHOCARBAMOL MANUFACTURED IN HANKO, FINLAND. DANAZOL USP MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA. BENDROFLUMETHIAZIDE USP AS MFG. IN VARESE ITALY

4Q2012

MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN UPPSALA, SWEDEN. INDIUM-III CITRATE ANTIBODY GRADE 7590 AS MFG. IN SAN DIEGO TOLAZAMIDE AS MFG. IN UDINE, ITALY ESERINE SALICYLATE SALT AS MFG. IN ST. LOUIS, MISSOURI TRAZODONE HYDROCHLORIDE AS MFG. IN CARLSTADT, NEW JERSEY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CHARLESTON, SOUTH CAROLINA. CYCLOPHOSPHAMIDE MONOHYDRATE AS MFG. IN SIMI VALLEY, CALIF. HALOPROGIN MANUFACTURED IN SIMI VALLEY, CALIFORNIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN VILLIAGE-NEUF, FRANCE. 1-METHYL-2-(3-PYRIDYL) PYRROLIDINE (NICOTINE) MANUFACTURED IN NEW YORK. 1, METHYLAMINO-1-METHYLTHIO-2-NITROETHENE AS MFG. IN ENGLAND POTASSIUM BICARBONATE, USP MANUFACTURED IN DELAWARE WATER GAP, PENNSYLVANIA. PSEUDOEPHEDRINE HCL USP,AS MFG IN DELAWARE WATER GAP,PA BETAMETHASONE VALERATE AS MFG. IN KALAMAZOO, MICHIGAN POLYETHYLENE AND POLYPROPYLENE CONTAINERS MFG.-NEW CASTLE,PA. NUOPLAZ 6959 (PLASTICIZER) AS MFG. IN CHESTERTOWN, MD PLASTIC BOTTLE CONTAINERS AS MFG. IN GREENSBORO, NC. FLUPHENAZINE DECANOATE AS MFG. IN THE NETHERLANDS MICROCRYSTALLINE CELLULOSE USP MANUFACTURED IN FINLAND. TITRIPLEX VS (DIETHYLENETRIAMINEPENTAACETIC ACID) MFG. GERMANY OXYBUTYNIN HYDROCHLORIDE AS MFG. IN LIMAY FRANCE CODEINE PHOSPHATE AS MFG. IN WILMINGTON, DELAWARE IDAZOXAN CAPSULES AS MFG. IN THE UNITED KINGDOM

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4Q2012EXCEL DMF# 6415 I 6416 6417 I 6418 6419 6420 6421 6422 I 6423 I 6424 I 6425 6426 A 6427 6428 6429 6430 6431 6432 6433 6434 6435 6436 6437 6438 6439 6440 6441 6442 6443 6444 I 6445 6446 6447 6448 I I I I II III II V 6/27/1986 6/11/1986 7/2/1986 6/10/1986 WYETH AYERST LABORATORIES INC SOLVAY & CIE SA JOHNSON MATTHEY PLC HOLOPAK GMBH I A I I I I I I I I I I I A I I I I II II II II II II II II I II II II II III III II I 6/13/1986 6/18/1986 6/9/1986 6/17/1986 6/19/1986 6/17/1986 6/17/1986 1/9/1984 6/18/1986 6/25/1986 6/18/1986 6/25/1986 6/23/1986 6/27/1986 6/26/1986 6/26/1986 6/23/1986 6/26/1986 DAINIPPON PHARMACEUTICAL CO LTD KATWIJK CHEMIE BV OLIN RESEARCH CENTER DC CHEMICAL CO LTD CARLSBERG BIOTECHNOLOGY LTD STEROID STABILIMENTS STEROID SRL HOFFMANN LA ROCHE INC SIGMA F AND D DIV LTD SOLVAY PHARMACEUTICALS HONEYMEAD PRODUCTS CO SUMIKA FINE CHEMICALS CO LTD DINAMITE DIPHARMA SPA NORDION CANADA INC HELVOET PHARMA MARYLAND HELVOET PHARMA MARYLAND PHARMACIA AND UPJOHN INC NORDEN ANDBRO I II V 6/11/1986 6/12/1986 III 2/28/1986 II 5/16/1986 I I I A II III II II II 6/2/1986 7/1/1985 6/5/1986 6/18/1986 6/11/1986 I I III 6/10/1986 4/25/1986 STATUS Type SUBMIT DATE II 6/12/1986 HOLDER RECKITT & COLMAN PRODUCTS LTD PHARMACEUTICAL DIV HOFFMANN LAROCHE F AND CO LTD ABBOTT LABORATORIES HOSP PRODUCTS DIV CYCLO PRODUCTS INC HELVOET PHARMA NV NEN LIFE SCIENCE PRODUCTS FINE CHEMICALS CORP PTY LTD LABORATORY FOR ANALYTICAL BIOLOGY INC SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP GETTIG PHARMACEUTICAL INSTRUMENT CO DIV GETTIG TECHNOLOGIES INC SANOFI PHARMACEUTICALS INC STERIGENICS INTERNATIONAL SUBJECT IDAZOXAN DRUG SUBSTANCE AS MFG. IN THE UNITED KINGDOM MANUFACTURING FACILITY LOCATED IN BASLE, SWITZERLAND FC85 PLASTIC (FLEXIBLE CONTAINERS) AS MFG. IN NO.CHICAGO,IL. BUSPIRONE HYDROCHLORIDE AS MFG IN LOS ANGELES, CALIFORNIA RUBBER CLOSURES AS MFG. IN BELGIUM IONIC GALLIUM-68 MFG IN NO. BILLERICA, MA BACLOFEN AS MFG. IN CAPE PROVINCE, SOUTH AFRICA

4Q2012

ERGOTAMINE IN HUMAN PLASMA MANUFACTURED IN MORRISTOWN, NEW JERSEY. CARBON-14 ALBENDAZOLE SUSPENSION AS MFG. IN PHILADELPHIA, PA. RUBBER CLOSURE FORMULATION, GP 1502/45 AS MFG. IN KNOX, IN. CHLOROQUINE BASE AND PHOSPHATE AS MFG. IN NORTHUMBERLAND,ENG. STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN WESTERVILLE, OHIO FACILITIES, PERSONNEL, AND PROCEDURES AT SUZUKA-SHI, JAPAN VALPROIC ACID AS MFG IN THE NETHERLANDS OMADINE MDS AS MFG. IN SWORDS, IRELAND HEXACHLOROPHENE MANUFACTURED IN KYUNG BUK, KOREA. IGE PENTAPEPTIDE ACETATE AS MFG. IN COPENHAGEN, DENMARK OXYMETHOLONE USP MANUFACTURED IN MILAN, ITALY. STANOZOLOL USP AS MFG. IN MILAN, ITALY PROTIRELIN (THYROTROPIN RELEASING HORMONE),MFG IN BASLE, SZ FRUCTOSE 1,6-DIPHOSPHATE AS MFG IN ST.LOUIS, MISSOURI HORMONE MFG. FACILITY LOCATED IN BAUDETTE, MINNESOTA EDIBLE LIQUID SOYBEAN OIL MANUFACTURED IN MANKATO, MINNESOTA. METOLAZONE AS MFG. IN JAPAN SULINDAC USP AS MFG. IN MILAN, ITALY IODINE 123 CP VCR 804-2 MANUFACTURED IN VANCOUVER, CANADA. RUBBER CLOSURE FORMULATION B5000-45 GRAY MFG IN SALISBURY MD RUBBER CLOSURE FORMULATION B5000-55 GRAY-MFG IN SALISBURY,MD OLSALAZINE SODIUM AS MANUFACTURED IN DOTTIKON, SWITZERLAND MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PITMAN, NEW JERSEY. OXAZEPAM AS MFG. IN HAVANT, ENGLAND BENVIC EB 652/5405-A, RIGID PVC COMPOUND MANUFACTURED IN ITALY. PENTAMIDINE ISETHIONATE,(BULK) AS MFG. IN WEST DEPTFORD, NJ ASEPTIC PROCESSING FACILITY FOR ROMMELAG(R) BOTTELPACK(R)BLOW-FILL-SEAL TECHNOLOGY IN SULZBACH AND UNTERGRONINGEN, GERMANY

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4Q2012EXCEL DMF# 6449 I 6450 6451 6452 6453 6454 I 6455 I 6456 6457 A 6458 6459 A 6460 A 6461 A 6462 6463 6464 I 6465 6466 I 6467 6468 6469 6470 6471 6472 6473 6474 6475 6476 6477 6478 6479 I 6480 6481 I I I II 7/17/1986 1/31/1986 CIPLA LTD BAYER CORP I I I I I I I I I I I I II II II I II II III I II III I I I 7/11/1986 6/17/1986 6/15/1986 6/30/1986 7/9/1986 1/23/1985 6/25/1986 7/11/1986 7/9/1986 7/14/1986 7/17/1986 7/17/1986 7/17/1986 I III II 1/7/1984 6/25/1986 A I III III I 6/30/1986 1/7/1986 6/20/1986 B BRAUN MEDICAL INC SOLVAY & CIE SA BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO SOLVAY & CIE SA ORION CORPORATION FERMION OULU PLANT MIKART INC HEXAGON LABORATORIES INC HEXAGON LABORATORIES INC PHARMACIA AND UPJOHN INC CUNO INC HEXAGON LABORATORIES INC INTRAPAC CORP NOVOPHARM LTD HOECHST CELANESE CORP WEST AMERICAN RUBBER CO CIPLA LTD CIPLA LTD CIPLA LTD III 6/30/1986 B BRAUN MEDICAL INC III 6/30/1986 B BRAUN MEDICAL INC A III III 6/30/1986 6/30/1986 B BRAUN MEDICAL INC B BRAUN MEDICAL INC I II III 6/18/1986 6/30/1986 EPROVA AG B BRAUN MEDICAL INC II 7/1/1986 CUNO INC I I I I I II II III III 6/25/1986 4/24/1986 7/2/1986 5/14/1986 7/3/1986 STATUS Type SUBMIT DATE II 7/2/1986 HOLDER AMERSHAM INTERNATIONAL PLC AMERSHAM LABORATORY STEROID SRL SIGMA F AND D DIV LTD RHONE-POULENC SANTE DRG MEDICAL PACKAGING INC SUBJECT YTTRIUM 90Y SILICATE AS MFG. IN BUCKINGHAMSHIRE, ENGLAND FACILITIES,PERSONNEL,AND OPERATING PROC. A COLOGNO MONZESE,IT BETA-PHENYLETHYLAMINE HYDROCHLORIDE AS MFG IN ST. LOUIS, MO. ALLOPURINOL AS MFG. IN SEINE CEDEX, FRANCE 2438 COATING PAPER AS MFG. IN MADISON, WISCONSIN

4Q2012

INTERNATIONAL MEDICATION SYSTEMS LTD RUBBER CLOSURES AND VIAL INJECTORS AS MFG. IN CALIFORNIA ZETAPOR O.45 WP MEMBRANE CARTRIDGES MANUFACTURED IN MERIDEN, CONNECTICUT. FENOFIBRATE (PROCETOFEN) MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND. STERILIZATION PROGRAM FOR THE EXCEL PLASTIC CONTAINER (ESUB) AS MANUFACTURED IN IRVINE CA MATERIAL QUALIFICATION FOR THE EXCEL PLASTIC CONTAINER (ESUB) VAPOR TRANSMISSION STUDIES FOR THE EXCEL PLASTIC CONTAINER (ESUB) CHEMISTRY MANUFACTURING AND CONTROLS FOR THE EXCEL PLASTIC CONTAINER (ESUB) INK QUALIFICATION STUDIES FOR THE EXCEL PLASTIC CONTAINERS (ESUB) AS MANUFACTURED IN IRVINE, CA ACCELERATED STUDIES FOR THE EXCEL PLASTIC CONTAINER (ESUB) ELTEX B 4921 AS MFG. IN BRAZIL METHODS, FACILITIES, AND CONTROLS IN MAYAGUEZ, PUERTO RICO HD-PE COPOLYMER ELTEX A 4009 AS MFG. IN ROSIGNANO, ITALY MINOXIDIL AS MFG IN FINLAND LORTAB TABLETS AS MFG. IN ALANTA, GEORGIA METHOCARBAMOL AS MFG. IN BRONX, NEW YORK PROPANTHELINE BROMIDE AS MFG. IN BRONX, NEW YORK FACILITIES AND CONTROLS IN WEST SUSSEX, U.K. MFG. OF ZETAPOR 0.20UM ST MEMBRANE CARTRIDGES, MERIDEN, CT THIORIDAZINE HYDROCHLORIDE AS MFG. IN BRONX, NEW YORK PLASTIC BOTTLES AND CLOSURES AS MFG. IN SWEDESBORO, N.J. FACILITIES, PERSONNEL,OPERATING PROC. AT ONTARIO, CANADA ACETOHEXAMIDE USP AS MFG IN COVENTRY, RHODE ISLAND WEST AMERICAN RUBBER COMPOUND 55-P-146 MFG IN ORANGE, CA FACILITIES, CONTROLS, AND OPERATING PROC. AT BANGALORE, INDIA FACILITIES, CONTROLS, AND OPERATING PROC. AT VIKHROLI, INDIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PATALGANGA, INDIA. FACILITIES, CONTROLS AND OPERATING PROC. AT BOMBAY, INDIA BOVINE THROMBIN AS MFG IN ELKHART, INDIANA

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4Q2012EXCEL DMF# 6482 6483 6484 6485 6486 6487 6488 6489 6490 6491 6492 6493 6494 A 6495 A 6496 6497 6498 6499 6500 6501 6502 6503 6504 6505 6506 6507 6508 I 6509 6510 I 6511 6512 6513 6514 6515 I 6516 I 6517 I I 8/1/1986 V 7/17/1986 I I I I II IV II I V 7/30/1986 7/31/1986 7/30/1986 7/31/1986 7/9/1986 I I V 7/23/1986 7/17/1986 I I I A A A I I A A I A II II II II II V II II II II II II V 7/18/1986 7/29/1986 7/29/1986 7/28/1986 7/28/1986 6/18/1986 7/18/1986 7/21/1986 7/29/1986 7/23/1986 7/11/1986 7/22/1986 7/17/1986 II 5/23/1986 STATUS Type SUBMIT DATE I I I I I I I I I I A I III III III II II II II II II II II III II 9/9/1985 6/2/1986 6/2/1986 7/7/1986 7/17/1986 3/3/1986 7/18/1986 7/17/1986 6/17/1986 7/24/1986 7/23/1986 7/17/1986 7/31/1986 HOLDER HUBERT DEBACKER & CO PVB WINGFOOT FILMS CORP WINGFOOT FILMS CORP LABOCHIM MIKART INC HEXAGON LABORATORIES INC SOCIETA ITALIANA CORTICOSTEROIDI SPA ACF CHEMIEFARMA NV DANISCO INGREDIENTS MIKART INC DELMAR CHEMICALS LTD SEDA SPECIALTY PACKAGING CORP RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL HEINRICH MACK NACHF QUATRUM SHOWA DENKO KK CIPLA LTD CIPLA LTD STERIS ISOMEDIX SERVICES HEINRICH MACK NACHF HILL DERMACEUTICALS INC BACHEM AMERICAS,INC DIPHARMA FRANCIS SRL ROHM AND HAAS CO NV ORGANON LABORATORY FOR ANALYTICAL BIOLOGY INC CAROLINA MEDICAL PRODUCTS CO LABORATORY FOR ANALYTICAL BIOLOGY INC SCHERING CHEMICALS LTD GATTEFOSSE ESTABLISSEMENTS FISONS PHARM LTD RAYLO CHEMICALS LABORATORY FOR ANALYTICAL BIOLOGY INC LABORATORY FOR ANALYTICAL BIOLOGY INC HELSINN CHEMICALS SA SUBJECT INJECTION MOULDED PLASTIC CONTAINERS AS MFG. IN BELGIUM POLYETHYLENE FILM AS MFG IN CARROLLTON, OHIO POLYETHYLENE FILM AS MFG IN BOWLING GREEN, KENTUCKY PENTOXIFYLLINE MANUFACTURED IN MILAN, ITALY. LORTAB 7 TABLETS AS MFG. IN ALANTA, GEORGIA METOLAZONE AS MFG. IN BRONX, NEW YORK MEDROXYPROGESTERONE ACETATE AS MFG. IN MILANO, ITALY SULFASALAZINE AS MFG. IN MAARSSEN, THE NETHERLANDS BUTABARBITAL MANUFACTURED IN GRINDSTED, DENMARK. LORCET PLUS TABLETS MANUFACTURED IN ALANTA, GEORGIA. PENTAMIDINE ISETHIONATE MANUFACTURED IN QUEBEC, CANADA. JARS, CLOSURES AND VIALS MANUFACTURED IN PLATSBURGH, NEW YORK. FLAVOXATE HYDROCHLORIDE AS MFG. IN LATINA, ITALY BUPIVACAINE HYDROCHLORIDE AS MFG. IN FIRENZE, ITALY RIBAVIRIN AS MFG. IN THE FEDERAL REPUBLIC OF GERMANY TRIAMCINOLONE ACETONIDE AS MFG. IN PORTUGAL SPECIFIC DRUG SUBSTANCES FOR L-TRYPTOPHAN IN JAPAN VINBLASTINE SULFATE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA VINCRISTINE SULFATE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA CONTRACT STERILIZATION FACILITY IN LIBERTYVILLE (NORTH), ILLINOIS. 5-FLUORO-2'-DEOXYURIDINE AS MFG. IN THE FED. REP. OF GERMANY DERMA-SMOOTHE CAPSULES AS MFG BY MIKART,INC IN ALANTA, GA. SALMON CALCITONIN (SCT) MANUFACTURED IN TORRANCE, CALIFORNIA. NIFEDIPINE USP AS MFG. IN MILAN, ITALY CHOLESTYRAMINE RESIN, USP-AMBERLITE IRP-276 MFG IN ITALY ARGININE VASOPRESSIN AS MFG. IN THE NETHERLANDS VALIDATION REPORT ON FLURAZEPAM AND IT'S MAJOR METABOLITES FACILITIES, PERSONNEL AND GENERAL OPER. PROC. IN N. CAROLINA DETERMINATION OF HALOPERIDOL IN HUMAN PLASMA USING GC-MS ULTRALANUM CREAM PLAIN MANUFACTURED IN ENGLAND. PRECIFAC AS MFG. IN SAINT PRIEST, FRANCE NEDOCROMIL SODIUM MANUFACTURED IN CHESHIRE, ENGLAND. FACILITIES, PERSONNEL AND OPERATING PROCED. IN ALBERTA, CANADA VALIDATION REPORT ON NITROGLYCERIN METABOLITES VALIDATION REPORT ON PRAZEPAM AND IT'S MAJOR METABOLITES

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MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SWITZERLAND. Page

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4Q2012EXCEL DMF# 6518 6519 6520 6521 6522 6523 6524 6525 6526 6527 6528 I 6529 6530 6531 6532 I 6533 6534 6535 6536 6537 6538 6539 6540 6541 I 6542 6543 I 6544 6545 I 6546 6547 6548 I 6549 I 6550 I 6551 I III 7/30/1986 III 7/30/1986 III 7/30/1986 I I II II III 8/19/1986 8/25/1986 7/30/1986 WHITBY RESEARCH INC DUPHAR BV SOCIETE BOURGUIGNONNE D'APPLICATIONS PLASTIQUES SOCIETE BOURGUIGNONNE D'APPLICATIONS PLASTIQUES SOCIETE BOURGUIGNONNE D'APPLICATIONS PLASTIQUES SOCIETE BOURGUIGNONNE D'APPLICATIONS PLASTIQUES I II I 8/19/1986 8/15/1986 PFIZER S/A JM HUBER POLYMER SERVICES GRP A IV I 7/9/1986 8/15/1986 LUBRIZOL ADVANCED MATERIALS INC PFIZER CHEMICAL CORP A A I I A I I I II II II II II IV II III III 8/12/1986 7/31/1986 8/15/1986 8/9/1986 8/12/1986 8/14/1986 8/6/1986 8/7/1986 8/15/1986 NIPPON KAYAKU CO LTD NORDION CANADA INC IROPHARM LTD RHONE-POULENC SANTE NIPPON KAYAKU CO LTD HERCULES INC BERK PHARMACEUTICALS LTD PCI SERVICES HELVOET PHARMA MARYLAND I A I II II II I 8/8/1986 7/25/1986 6/9/1986 8/11/1986 STATUS Type SUBMIT DATE I I I I A I A A I I II II III II II II II II II II III 4/11/1986 8/1/1986 8/6/1985 6/19/1986 8/7/1986 8/6/1986 8/7/1986 8/11/1986 8/12/1986 7/24/1986 8/8/1986 HOLDER HELSINN CHEMICALS SA SELOC FRANCE MILLIKEN & CO CUNO INC CAMBREX PROFARMACO MILANO SRL PCAS CAMBREX PROFARMACO MILANO SRL PHARMACIA AND UPJOHN SUB PFIZER INC ORGANICHEM CORP BOEHRINGER INGELHEIM KG TECHNICAL COATINGS CO SUB OF BENJAMIN MOORE & CO LABORATOIRE CHOAY BOEHRINGER INGELHEIM CHEMICALS INC ANTIBIOTICOS SPA RICHARDSON-VICKS INC SUBJECT CHLORZOXAZONE DRUG SUBSTANCE AS MFG. IN BIASCA, SWITZERLAND SODIUM VALPROATE MANUFACTURED BY SIFA LTD IN IRELAND. MILLAD 3905 (DIBENZYLIDENE SORBITOL) AS MFG. IN S.CAROLINA

4Q2012

ZETAPOR 0.45 UM SP MEMBRANE CARTRIDGES MANUFACTURED INMERIDEN,CT ALBUTEROL SULPHATE AS MFG. IN MILAN, ITALY TRIMIPRAMINE MALEATE MANUFACTURED BY SIFA LTD IN IRELAND. ALBUTEROL BASE AS MFG. IN MILAN, ITALY DEXAMETHASONE SODIUM PHOSPHATE MANUFACTURED IN KALAMAZOO, MICHIGAN. AMINOBISAMIDE HYDROCHLORIDE AS MFG. IN RENSSELAER, NEW YORK PHYSOSTIGMINE SALICYLATE MANUFACTURED IN GERMANY. 30030 HEAT SEAL FOR FOIL TO FOIL, POLYCARBONATE, PVC & OTHER AMIODARONE HYDROCHLORIDE INJECTION AS MFG. IN MAROMME, FRANCE METAXALONE MANUFACTURED IN PETERSBUG, VIRGINIA. IBUPROFEN MANUFACTURED IN MILANO, ITALY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NORTH CAROLINA. DEOXYSPERGUALIN HYDROCHLORIDE FOR INJECTION MANUFACTURED INJAPAN MOLYBDENUM-99 (FISSON) AS MFG. IN ONTARIO, CANADA IMIPRAMINE HYDROCHLORIDE AS MFG. IN IRELAND GADOLINIUM OXIDE 99.99 (PHOSPHOR GRADE) AS MFG. IN FRANCE DEOXYSPERGUALIN HYDROCHLORIDE AS MFG. IN SHIGA-KEN, JAPAN HYDROXYPROPYL CELLULOSE AS MFG. IN HOPEWELL, VIRGINIA ACTIVE & PLACEBO FUROSEMIDE (FRUSEMIDE TABS) 40MG MFG ENGLAND PACKAGING PROCEDURES A ESSEX, UK RUBBER CLOSURE FORMULATION B5001-45 GRAY MANUFACTURED IN SALISBURY, MARYLAND. NOVEON CA-1/NOVEON CA-2 (CALCIUM POLYCARBOPHIL USP) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RINGASKIDDY, IRELAND. TINIDAZOLE MANUFACTURED IN SSAO PAULO, BRAZIL. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ORANGE, TEXAS. N-0437 SYNTHESIS AND NON-CLINICAL STUDIES A IRVINE, CALIF. CALCITRIOL AS MANUFACTURED AND PACKED IN THE NETHERLANDS BENVIC PEB 02 P/0546 AS MFG. IN QUETIGNY, FRANCE BENVIC PEB 02 P/0102 AS MFG. IN QUETIGNY, FRANCE BENVIC PEB 01 P/0546 (A PVC CMPD) AS MFG IN QUETIGNY,FRANCE BENVIC PEB 01 P/0102 MANUFACTURED IN QUETIGNY, FRANCE.

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4Q2012EXCEL DMF# 6552 I 6553 6554 A 6555 A 6556 I 6557 6558 6559 6560 6561 6562 I 6563 6564 6565 6566 6567 I 6568 6569 6570 6571 6572 I 6573 I 6574 6575 6576 I 6577 6578 6579 6580 6581 6582 6583 6584 6585 I I I I A I I I I II III II II II II II IV I 9/12/1986 9/5/1986 9/9/1986 12/24/1985 8/28/1986 9/8/1986 9/12/1986 8/20/1986 9/17/1986 I I III II II 5/10/1985 9/11/1986 9/12/1986 II 9/10/1986 I I I I II II II II II 9/4/1986 8/2/1982 8/28/1986 8/28/1986 9/10/1986 I I I I II I III I III 8/30/1986 9/5/1986 9/3/1986 8/28/1986 8/18/1986 I I I I I III II II II II II 8/25/1986 9/1/1986 8/29/1986 8/29/1986 8/7/1986 8/22/1986 I 7/14/1986 V 8/18/1986 I II V 8/13/1986 8/18/1986 STATUS Type SUBMIT DATE I 8/18/1986 HOLDER EXTAL PTY LTD DIV JOHNSON AND JOHNSON QUATRUM SYNERGY HEALTH STERILISATION UK LTD SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TASMANIA, AUSTRALIA. TRIAMCINOLONE BASE AS MFG. IN SACAVEM, PORTUGAL

4Q2012

COBALT 60 GAMMA IRRADIATION CONTRACT STERILIZATION FACILITY LOCATED IN READING, BERKSHIRE, ENGLAND SYNERGY HEALTH STERILISATION UK LTD COBALT 60 GAMMA IRRADIATION CONTRACT STERILIZATION FACILITY LOCATED IN BRADFORD, WEST YORKSHIRE, ENGLAND PROCTER AND GAMBLE PHARMACEUTICALS FACILITIES, PERSONNEL AND OPER. PROC. AT WEITERSTADT, GERMANY GERMANY GMBH STATOIL POLYETHYLENE RESIN L500 AS MFG. IN STAHELLE, NORWAY ORGANICHEM CORP ETHYL CORP DIOSYNTH BV TSUJIMOTO KAGAKU KOGYO CO LTD UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER TOKUYAMA CORP ZENITH LABORATORIES INC 3M PHARMS ASTA PHARMA AG SOCIETE BOURGUIGNONNE D'APPLICATIONS PLASTIQUES EGIS PHARMACEUTICALS CONTINENTAL PHARMA SA UNIBIOS SPA HEXAGON LABORATORIES INC HARTINGTON CHEMICALS DIV STAVELEY CHEMICALS LTD HARTINGTON CHEMICALS DIV STAVELEY CHEMICALS LTD DOW CORNING CORP JOHNSON MATTHEY PLC NORWICH EATON PHARMACEUTICALS INC SUB PROCTOR AND GAMBLE CO ROHM PHARMA GMBH MITSUI CHEMICALS INC LABOCHIM ICI AMERICAS INC BASF SE HOFFMANN LA ROCHE INC ATOMIC ENERGY OF CANADA LTD MIKART INC KNOLL AG SR-2508, HYPOXIC CELL RADIOSENSITIZER MANUFACTURED IN LINZ, AUSTRIA. TOLRESTA MANUFACTURED IN BATON ROUGE, LOUISIANA. 6-ALPHA-METHYLPREDNISOLONE SODIUM SUCCINATE MFG. NETHERLANDS DEXTROMETHORPHAN PHENOLPHTHALINATE AS MFG. IN OSAKA, JAPAN CYCLOTRON-PRODUCED RADIOPHARMACEUTICALS AS MFG. IN TEXAS CHLORZOXAZONE USP AS MFG. A THE IBARAKI PREFECTURE JAPAN FAC FACIL. AND OPER. PROC. A PRALEX CORP. IN ST. CROIX,VIRGIN ISL SCOTCHPAK BRAND HEAT SEALABLE POLYESTER FILM NO. 6 PRODUCTION PLANT AT KUNSEBECK, GERMANY BENVIC IB 56C/0102 AS MFG. IN QUETIGNY, FRANCE CLOMIPHENE CITRATE USP AS MFG. IN BUDAPEST, HUNGARY CP 751 S TABLETS MANUFACTURED IN BRUSSELS, BELGIUM. NALIDIXIC ACID MANUFACTURED IN TRECAE, ITALY. BROMPHENIRAMINE MALEATE USP MANUFACTURED IN BRONX, NEW YORK. ACETAMINOPHEN D.C. PVP AS MFG. IN THE UNITED KINGDOM ACETAMINOPHEN D.C. 90 PVP MANUFACTURED IN UNITED KINGDOM. SILASTIC QCF7-2856 ELASTOMER AS MFG. IN MIDLAND, MICHIGAN SOTRADECOL GEL MANUFACTURED IN WEST DEPTFORD, NEW JERSEY. ASACOL (5-AMINOSALICYLIC ACID) TABLETS MANUFACTURED IN NORWICH, NEW YORK. ASACOL TABLETS MANUFACTURED IN WEITERSTADT, GERMANY. TAFMER A 4085 RESIN COMPOUNDS MANUFACTURED IN TOKYO, JAPAN. FLUPHENAZINE DECANOATE AS MFG. IN MILAN, ITALY METHYLENE CHLORIDE MANUFACTURED IN CHESHIRE, ENGLAND. VITAMIN A PALMITATE AS MFG.IN GERMANY RIBOFLAVIN 5'-PHOSPHATE SODIUM AS MFG.IN VILLIAGE-NEUF,FRANCE CP-VCR 807 GA-67 MANUFACTURED IN VANCOUVER, CANADA. LORTAB LIQUID AS MFG. IN ALANTA, GEORGIA FACILITIES, PERSONNEL AND PROCEDURES IN LIESTAL, SWITZERLAND

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4Q2012EXCEL DMF# 6586 6587 6588 6589 6590 6591 A 6592 6593 I 6594 6595 6596 6597 I 6598 6599 6600 6601 6602 6603 6604 6605 6606 A 6607 6608 6609 6610 6611 6612 6613 6614 I 6615 6616 I 6617 6618 6619 6620 6621 I C I A I III II I III IV 9/26/1986 10/2/1986 10/9/1986 10/2/1986 10/2/1986 I IV V 9/29/1986 10/3/1986 INDUSTRIAS CAPSUVAR SA LABORATORY FOR ANALYTICAL BIOLOGY INC BASF CORP TEVA PHARMACEUTICALS INDUSTRIES LTD ZENITH LABORATORIES INC HOSPIRA INC VEB GELATINE UND LEIMWERKE I I A I I A I III II III I IV III II I 9/16/1986 9/24/1986 10/1/1986 9/29/1986 10/2/1986 9/26/1986 9/29/1986 2/18/1985 I I A I I A I I II II IV II II II II II II 9/24/1986 10/29/1986 9/23/1986 9/24/1986 9/23/1986 9/22/1986 9/24/1986 9/23/1986 9/24/1986 I A I II III III II 9/25/1986 9/23/1986 9/15/1986 9/22/1986 I I IV 9/17/1986 8/8/1986 RHONE POULENC PHARMACY INC FACILITIES, PERSONNEL AND PROCEDURES AT MONTREAL, CANADA DRAGOCO RIECH UND GESCHMACK STOFFE NATURAL PEPPERMINT POWDER FLAVOR AND MENTHOL CRYSTALIZED GMBH FINE CHEMICALS CORPORATION SILVER SULPHADIAZINE MICRONIZED AS MFG. IN SOUTH AFRICA WITTEN MANUFACTURING CO WITTEN MANUFACTURING CO INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA SANDOZ PHARMS CORP DIV SANDOZ INC CIPLA LTD JRS PHARMA LP NOVARTIS PHARMACEUTICALS CORP KV PHARMACEUTICAL CO MOEHS IBERICA SL NOVARTIS PHARMACEUTICALS CORP CILAG CHEMIE AG PURIFIED COTTON USP AS MFG. IN GASTONIA, NORTH CAROLINA PURIFIED RAYON AS MFG. IN GASTONIA, NORTH CAROLINA METAPROTERENOL SULPHATE USP AS MFG. IN NIMIS (UDINE) ITALY STATUS Type SUBMIT DATE I I I I I II II II II II III 2/6/1986 9/19/1986 9/19/1986 9/18/1986 9/19/1986 9/23/1986 HOLDER EURAND AMERICA INC HEXAGON LABORATORIES INC HEXAGON LABORATORIES INC HEXAGON LABORATORIES INC HEXAGON LABORATORIES INC SUBJECT MICROENCAPSULATED ASPIRIN AS MFG. IN VANDALIA, OHIO CHLORPROMAZINE HCL USP MANUFACTURED IN BRONX, NEW YORK. IBUPROFEN USP MANUFACTURED IN BRONX, NEW YORK. AMANTIDINE HYDROCHLORIDE MANUFACTURED IN BRONX, NEW YORK. DISOPYRAMIDE PHOSPHATE USP AS MFG. IN BRONX, NEW YORK

4Q2012

VERTELLUS PERFORMANCE MATERIALS INC MORFLEX CITROFLEX B-6 AS MFG. IN GREENSBORO, NC

CHLORPHENIRAMINE BASE MANUFACTURED IN EAST HANOVER, NEW JERSEY. METOPROLOL TARTRATE AS MFG. IN INDIA EMCOCEL 90M MICROCRYSTALLINE CELLULOSE USP MANUFACTURED IN FINLAND. PYRILAMINE BASE AS MFG. IN EAST HANOVER, NEW JERSEY IBUPROFEN DIHYDROCODEINE F.C. TABLETS AS MFG. IN ST. LOUIS MO TRIAMTERENE AS MFG. IN RUBI (BARCELONA) SPAIN PYRILAMINE MALEATE AS MFG. IN EAST HANOVER, NEW JERSEY MESALAZINE AS MFG. IN SCHAFFHAUSEN, SWITZERLAND

NOBEL CHEMICALS AB DIV FINE CHEMICALS N,N'-BIS(2,3-DIHYDROXYPROPYL)-5-AMINO-ISOPHTHAMALIMIDE HCL INC SWISSPACK CORP TUBES AND CLOSURES MANUFACTURED IN LINCOLN PARK, NEW JERSEY. HEXACHIMIE SA COMAR UNICON PUERTO RICO LLC AMEND RUGER CHEMICAL CO ROQUETTE CORPORATION PPG PACKAGING AND COATINGS DIOSYNTH BV RP SCHERER CORP 1-(3-CHLOROPHENYL) PIPERAZINE HYDROCHLORIDE MANUFACTURED IN FRANCE. PLASTIC PACKAGING COMPONENTS (ESUB) MANUFACTURED AT CAYEY, PR FACILITIES, PERSONNEL, AND OPERATING PROCEDURES IN NJ LYCASIN BRAND OF HYDROGENATED GLUCOSE SYRUP MFG. IN ILL INTERNAL PROTECTIVE LACQUER COATINGS AS MFG. IN GERMANY NORGESTOMET AS MFG. IN THE NETHERLANDS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ONTARIO, CANADA. EMPTY HARD GELATIN CAPSULES AS MFG. IN CARACUS, VENEZUELA EFFECTS OF BIPERIDEN ON THE PHARMOKINETICS OF HALOPERIDOL SANTICIZER 711 MFG. IN TEXAS CITY, TEXAS ALBUTEROL BASE AND SULPHATE (SALBUTAMOL) MANUFACTURED IN ITALY. FACILITIES, PERSONNEL, AND OPERATING PROCEDURES IN NJ BLOW/FILL/SEAL (B/F/S) SEMI-RIGID CONTAINER AS MFG. IN N.C. EMPTY HARD GELATIN CAPSULES MFG. IN GERMANY

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4Q2012EXCEL DMF# 6622 I 6623 6624 6625 6626 6627 6628 6629 6630 6631 6632 6633 6634 I 6635 I 6636 6637 I 6638 6639 6640 6641 6642 6643 6644 6645 I 6646 6647 I 6648 6649 I 6650 6651 6652 6653 6654 I 6655 6656 I I II II 10/28/1986 9/30/1986 EMERY CHEMICALS FINE CHEMICALS CORP PTY LTD I I A I II III II I II 10/29/1986 10/21/1986 8/8/1986 10/30/1986 10/31/1986 ROQUETTE FRERES SAFET EMBAMET LETHIAS FERMION OY MY K LABORATORIES INC NIACET CORP I II I 10/17/1986 10/27/1986 HOKURIKU SEIYAKU CO LTD LENNON LTD I II I 10/27/1986 10/22/1986 I I I A I I A II II IV II II II II II 10/21/1986 10/2/1986 10/2/1986 10/20/1986 10/6/1986 10/21/1986 9/10/1986 10/17/1986 MIKART INC GEDEON RICHTER GEDEON RICHTER FABBRICA ITALIANA SINTETICI SPA LASA LABORATORIOS SA IRISH FINE CHEMICALS LIMITED SIFAVITOR SRL ORCHIMIE SA (PRODUITS CHIMIQUES ET BIOCHIMIQUES) QUATRUM SPRAY TEK INC I II III 10/22/1986 10/20/1986 RELIABLE CHEMICAL CO ADVANCED ELASTOMER SYSTEMS I 10/21/1986 AMERICAN CUSTOM DRYING COMPANY INC I I I A I I I A I I I III III III II III III II III II III I I 9/30/1986 6/3/1986 6/3/1986 10/15/1986 9/22/1986 10/15/1986 10/14/1986 10/15/1986 10/13/1986 9/30/1986 10/14/1986 7/18/1986 STATUS Type SUBMIT DATE II 10/8/1986 HOLDER LABORATOIRES D'ETUDES ET DE RECHERCHES SYNTHELABO ALLPACK LTD ADRIAPLAST SPA ADRIAPLAST SPA SCHERING PLOUGH CORP IDEMITSU PETROCHEMICAL COMPANY LTD WYETH AYERST LABORATORIES INC DR REDDY'S LABORATORIES LTD FERRO CORP CUNO INC WILLIAM WARNE LTD TOKUYAMA CORP FERRING AB SUBJECT ZOLPIDEM TARTRATE MFG. IN GARGENVILLE, FRANCE PACKAGING OPERATIONS IN WAIBLINGEN, GERMANY. ALKORPACK-P PLASTIC SHEET PACKAGING AS MFG. IN ITALY VENIPAK-P PLASTIC SHEET PACKAGING AS MFG. IN ITALY LORATADINE AS MFG. IN COUNTY WICKLOW, IRELAND IDEMITSU POLYPROPYLENE FILM AS MFG. IN TOKYO, JAPAN PROTOCOLS FOR EQUIVALENCY OF PACKAGING COMPONENTS L-METHYL DOPA AS MFG. IN INDIA COLORANTS FOR PLASTICS MANUFACTURED IN STRYKER, OHIO. ZETAPOR 0.20 UM AND 0.45 SP FLAT STOCK MEMBRANE AS MFG.IN CT RUBBER SEALING GASKET PART #300H 42P AS MFG. IN ENGLAND FACILITIES PRODUCING PROPANTHELINE BROMIDE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MALMO, SWEDEN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BURLINGTON, NEW JERSEY. PROTAMINE SULFATE (BULK) MANUFACTURED IN ST. LOUIS, MISSOURI.

4Q2012

VYRAM THERMOPLASTIC RUBBER, GRADE 1055 MANUFACTURED IN ST. LOUIS, MISSOURI. LORCET PLUS TABLETS AS MFG. IN ALANTA, GEORGIA NORETHINDRONE 1 MG. AND MESTRANOL 0.05 MG. TABLETS IN BULK FINISHED DOSAGE FORM OF PLACEBO TABLETS AS MFG. IN HUNGARY CARBAMAZEPINE AS MFG. IN ITALY METHOCARBAMOL MANUFACTURED IN BARCELONA, SPAIN. DESIPRAMINE HYDROCHLORIDE AS MFG. IN WICKLOW, IRELAND TIMOLOL MALEATE AS MFG. IN ITALY PERPHENAZINE AS MFG. IN PITHIVIERS, FRANCE HYDROCORTISONE HEMISUCCINATE MANUFACTURED IN LISBON, PORTUGAL. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NEW JERSEY. TULOBUTEROL BASE AS MFG. BY YODOGAWA PHARMACEUTICAL CO.,LTD. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PORT ELIZABETH, SOUTH AFRICA. MANNITOL GRANULAR G.G. AS MFG. IN LESTREM, FRANCE SAFET MONOBLOC ALUMINUM CAN AS MFG. IN ST FLORENTIN, FRANCE TOREMIFENE CITRATE AS MFG. IN OULU, FINLAND FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN ILL. SODIUM ACETATE ANHYDROUS, USP GRADE MANUFACTURED IN NIAGARA FALLS, CANADA. EMTHOX 6946 (NONOXYNOL-9) MANUFACTURED IN SOUTH CAROLINA. THIOTHIXENE HYDROCHLORIDE AS MFG. IN CAPE PROVINCE, S AFRICA

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4Q2012EXCEL DMF# 6657 I 6658 6659 6660 6661 I 6662 A 6663 6664 I 6665 6666 I 6667 6668 I 6669 6670 6671 6672 A 6673 6674 6675 6676 6677 6678 I 6679 6680 6681 6682 I 6683 6684 6685 6686 6687 6688 6689 6690 I A I A A I A I II III II II II I II II 11/21/1986 11/17/1986 11/18/1986 11/14/1986 11/18/1986 11/20/1986 11/20/1986 11/20/1986 I I I II II I II 11/12/1986 11/20/1986 11/21/1986 11/18/1986 SYNTEX USA INC PENICK CORP SOLVAY PHARMACEUTICALS PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA HAARMANN & REIMER GMBH AMCOR FLEXIBLES SHELBYVILLE GANES CHEMICALS INC LUSOCHIMICA SPA HOVIONE FARMACIENCIA SA TEVA PHARM & CHEMICAL WORKS DIPHARMA FRANCIS SRL KV PHARMACEUTICAL CO I I I A A II II II III III I 11/12/1986 11/11/1986 11/20/1986 10/17/1986 10/22/1986 11/7/1986 SOCIETA ITALIANA CORTICOSTEROIDI SPA SOL PHARMACEUTICALS LIMITED SHIONOGI AND CO LTD EXXONMOBIL CHEMICAL CO EXXONMOBIL CHEMICAL CO PHARMACIA SPA I I I II II III V 11/10/1986 11/12/1986 11/5/1986 8/27/1986 A II II 11/5/1986 11/7/1986 NV ORGANON ORCHIMIE SA (PRODUITS CHIMIQUES ET BIOCHIMIQUES) DOCTOR REDDYS LABORATORIES LTD CUNO INC DUMA PACKAGING AS STERIGENICS INTERNATIONAL I II II 11/10/1986 11/10/1986 I II V 11/5/1986 11/7/1986 II 11/1/1986 A I I II II II II 10/29/1986 10/28/1986 10/2/1986 11/6/1986 EUTICALS SPA ZENECA INC GEDEON RICHTER INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA HERAEUS PRECIOUS METALS GMBH AND CO KG ACF CHEMIEFARMA NV INTERNATIONAL MEDICINES EXCHANGE & DEVELOPMENT EGIS PHARMACEUTICALS CUNO INC STATUS Type SUBMIT DATE I 10/29/1986 HOLDER NEO MICRO AG SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. SULFAPYRIDINE AS MFG. IN ITALY COSMOCIL CQ (POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE) NORETHINDRONE 1 MG. AND ETHINYL ESTRADIOL 0.035 MG. USP TABS. PINDOLOL AS MFG. IN MILAN, ITALY CIS-DIAMMINEDICHLORO-PLATINUM AS MFG. IN GERMANY DESIPRAMINE HYDROCHLORIDE MANUFACTURED IN MAARSSEN, HOLLAND. EMORFAZONE, CLINICAL AND PRE-CLINICAL STUDIES DIETHYLCARBAMAZINE CITRATE USP AS MFG. IN BUDAPEST, HUNGARY ZETA PLUS 90 LP MEDIA CARTRIDGES AND FLA STOCK MANUFACTURED IN CONNECTICUT. HUMAN MENOPAUSAL GONADOTROPHIN 100 AS MFG. IN THE NETHERLANDS CYTARABINE AS MFG. IN PITHIVIERS, FRANCE IBUPROFEN AS MFG. IN INDIA ZETA PLUS 60 LP MEDIA CARTRIDGES AND FLA STOCK MFG. IN CT. DUMA TAMPER-EVIDENT CONTAINERS AND DUMACAPS MFG. IN DENMARK

4Q2012

STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN FORT WORTH, TEXAS MEGESTROL ACETATE MANUFACTURED IN MILAN, ITALY. SULFAMETHOXAZOLE AND TRIMETHOPRIM AS MFG. IN INDIA. MOXALACTAM DIACID MANUFACTURED IN JAPAN. ESCORENE POLYPROPYLENE RESINS (1000 SERIES) MFG. IN TEXAS. ESCORENE POLYPROPYLENE RESINS (9000 SERIES) MANUFACTURED IN TEXAS. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MILAN, ITALY. METHYLTESTOSTERONE MANUFACTURED IN MORELOS, MEXICO. MORPHINE SULFATE AS MFG. IN NEWMARK, NEW JERSEY FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN GA HALOPERIDOL DECANOATE AS MFG. IN MILAN, ITALY DIBENZOSUBERONE AS MFG. IN THE FEDERAL REPUBLIC OF GERMANY FLEXIBLE PACKAGING MATERIALS MANUFACTURED IN KENTUCKY. 4-N,N-BIS(2-HYDROXYETHYL)-AMINOACETOPHENONE AS MFG. IN NJ DILTIAZEM HYDROCHLORIDE AS MFG. IN MILAN, ITALY BETAMETHASONE SODIUM PHOSPHATE AS MFG. IN PORTUGAL FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN JERUSALEM DICLOFENAC SODIUM AS MFG. IN MILAN, ITALY DISOPYRAMIDE S.R. CAPSULES (100 MG) MANUFACTYRED IN ST. LOUIS, MISSOURI.

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4Q2012EXCEL DMF# 6691 6692 6693 6694 6695 6696 6697 6698 6699 6700 6701 6702 I 6703 6704 6705 6706 I 6707 6708 6709 I 6710 6711 6712 6713 6714 6715 I 6716 6717 6718 6719 6720 6721 A 6722 6723 6724 6725 I 6726 I II 11/26/1986 I I I I I II II 12/15/1986 12/8/1986 11/25/1986 12/15/1986 ROYCE LABORATORIES ATOMIC ENERGY OF CANADA LTD UNION CARBIDE AND CARBON CORP COMPANIA ESPANOLA DE SINTESIS QUIMICA SA COMPANIA ESPANOLA DE SINTESIS QUIMICA SA FACILITIES, PERSONNEL AND CONTROLS IN FLORIDA FACILITIES AND GENERAL OPERATING PROCEDURES AT KANATA, CANADA CARBON DIOXIDE, XENON AND OXYGEN MIXTURE AS MFG. IN INDIANA 6-ALPHA METHYLPREDNISOLONE AS MFG IN MADRID BETAMETHASONE DIPROPIONATE AS MFG. IN MADRID, SPAIN I I I I I II I I II II II 12/11/1986 12/5/1986 11/26/1986 12/8/1986 12/5/1986 12/1/1986 I A I A I V II II II II II 12/3/1986 12/2/1986 12/5/1986 11/28/1986 12/3/1986 12/5/1986 TEVA PHARMACEUTICAL INDUSTRIES LTD MEDICHEM SA CAMBREX PROFARMACO MILANO SRL HOVIONE FARMACIENCIA SA LERS CHEM DEVELOPMENT ORCHIMIE SA (PRODUITS CHIMIQUES ET BIOCHIMIQUES) CHUGAI PHARMACEUTICAL CO LTD ROCHE AG MARIETTA CORP DAIICHI PURE CHEMICALS CO LTD BORREGAARD INDUSTRIES LTD EXCELLA GMBH I I II II I 12/3/1986 11/26/1986 12/5/1986 I I I V II II II 12/3/1986 12/3/1986 12/5/1986 12/4/1986 STATUS Type SUBMIT DATE I I A I I I I I I I I II I II II IV II II II II II IV I 11/18/1986 11/25/1986 11/25/1986 11/26/1986 11/26/1986 11/28/1986 11/19/1986 11/25/1986 12/2/1986 11/6/1986 12/17/1986 11/24/1986 HOLDER EMERY CHEMICALS RIVOPHARM SA FIDIA FARMACEUTICI SPA CUNO INC LONZA RIVERSIDE TOKUYAMA CORP BASF WYANDOTTE CORP PENNISULA LABORATORIES INC DIOSYNTH BV STERLING CHEMS INC SHANDONG ENTERPRISES LTD LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO EASTMAN CHEMICAL CO EASTMAN CHEMICAL CO CIPLA LTD SUBJECT EMEREST 2703 (PEG-4 LAURATE) AS MFG. IN MAULDIN, SC FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. MINOXIDIL MANUFACTURED IN MILAN, ITALY. ZETA PLUS 90 SP MEDIA CARTRIDGES AND FLA STOCK MFG. IN CT. FILM COATING SOLUTION AS MFG. IN CONSHOHOCKEN, PENNSYLVANIA SULFAMETHIZOLE AS MFG. IN JAPAN HDO 1,6-HEXANEDIOL MANUFACTURED IN FREEPORT, TEXAS. BRADYKININ (A PEPTIDE) MANUFACTURED IN BELMONT, CALIFORNIA. ORGOTEIN MANUFACTURED IN OSS, HOLLAND. LACTIC ACID 88% USP AND LACTIC ACID 88% LOW AMMONIA EMPTY HARD GELATIN CAPSULES AS MFG. IN PEOPLES REP. OF CHINA FACILITIES, PERSONNEL AND GENERAL OPER. PROCEDURES IN GERMANY 5-AMINOSALICYLIC ACID TOXICOLOGY AND CLINICAL INFORMATION 5-AMINOSALICYLIC ACID DOSAGE FORM FOR CLINICAL RESEARCH METHOCARBAMOL AS MFG. IN INDIA

4Q2012

WAITAKI INTERNATIONAL BIOSCIENCES SUB LINOLEIC ACID AS MFG. IN CANADA WAITAKI CANADA LTD SALK INST BIOLOGICAL STUDIES [N-METYR1,NLE27,ASN28]-HGRF(1-29)-NHET AS MFG. IN CALIFORNIA SIBEFAT SPA PACKAGING COORDINATORS INC VERAPAMIL HYDROCHLORIDE AS MFG. IN ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RICHMOND, VIRGINIA. STERILE PROCESSING FACILITY FOR CEPHALOSPORIN IN JERUSALEM, ISRAEL CHLORHEXIDINE BASE, DIACETATE & DIGLUCONATE SOLUTION NAPROXEN SODIUM AS MFG. IN MILAN, ITALY BETAMETHASONE 21-ACETATE AS MFG. IN LISBON, PORTUGAL CICLOPROLOL HYDROCHLORIDE AS MFG. IN FRANCE FLUPHENAZINE HYDROCHLORIDE AS MFG. IN FRANCE SG-75 (NICORANDIL) BULK DRUG PRODUCT AS MFG. IN JAPAN FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES METHIONINE-ENKEPHALIN AS MFG. IN JAPAN 5-AMINO-N,N'-BIS(2,3-DIHYDROXYPROPYL)-ISOPHTALAMIDE-HYDROCHLORIDE TRAZODONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY

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4Q2012EXCEL DMF# 6727 I 6728 I 6729 6730 6731 I 6732 I 6733 I 6734 I 6735 6736 6737 6738 6739 6740 6741 6742 I 6743 6744 I 6745 6746 6747 6748 6749 6750 6751 6752 6753 I 6754 6755 6756 6757 6758 6759 I I I I I I II II III II II II 12/30/1986 12/30/1986 12/15/1986 12/31/1986 12/30/1986 12/19/1986 A I I I I I I I IV I II II III II II III II 12/22/1986 12/29/1986 12/29/1986 12/22/1986 12/29/1986 12/24/1986 12/24/1986 12/30/1986 11/26/1986 I I II 12/19/1986 12/22/1986 A I I A I A I II II II II III II II II 12/15/1986 12/15/1986 12/16/1986 12/22/1986 11/19/1986 12/26/1986 12/22/1986 12/23/1986 FIDIA FARMACEUTICI SPA MAY AND BAKER LTD GEDEON RICHTER LTD GE HEALTHCARE BETHAM CORP OKAMI CHEMICAL INDUSTRY CO LTD DSM ANDENO RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA PRIME EUROPEAN THERAPEUTICALS S P A SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT BASF SE ANAQUEST DIV BOC INC ANAQUEST DIV BOC INC HEXAGON LABORATORIES INC DARTO MANUFACTURING INC BASF AKTIENGESELLSCHAFT BASF AKTIENGESELLSCHAFT SETCO COMPANIA ESPANOLA DE SINTESIS QUIMICA SA CUNO INC CUNO INC ALCAN CANADA FOILS ALDRICH CHEMICAL COMPANY INC CUNO INC PHARMECO LABORATORIES INC I 12/1/1986 SOCIETA ITALIANA MEDICINAL SCANDICCI MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. TAMOXIFEN CITRATE AS MFG. IN MILAN, ITALY KETOPROFEN AS MFG. IN DAGENHAM, ENGLAND. BROMOCRIPTINE MESYLATE USP AS MFG. IN BUDAPEST, HUNGARY SODIUM IODIDE I 123 PRODUCED VIA XENON XE 123 1510C FOAM PAD AS MFG. IN NEW JERSEY TIOPRONIN AS MFG. IN JAPAN CARBASALATE CALCIUM AS MFG. IN HOLLAND. CARBAMAZEPINE AS MFG. IN MILAN, ITALY. FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. L-LEUCINE-ISOPROPYLAMINOCYCLOL HYDROCHLORIDE AS MFG IN SWITZ. KOLLIDON VA 64 AS MFG. IN GERMANY. FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN OHIO ENDROPHONIUM CHLORIDE USP AS MFG. IN CLEVELAND, OHIO. CARBAMAZEPINE USP AS MFG. IN BRONX, NEW YORK. DARTCO XYDAR RESINS AS MFG. IN AUGUSTA, GEORGIA 43915-BASF AS MFG. IN THE FEDERAL REPUBLIC OF GERMANY 47011-BASF AS MFG. IN THE FEDERAL REPUBLIC OF GERMANY II 12/15/1986 CUNO INC II 12/15/1986 CUNO INC I I II II II 12/17/1986 12/15/1986 12/15/1986 I 11/26/1986 STATUS Type SUBMIT DATE II 11/26/1986 HOLDER COMPANIA ESPANOLA DE SINTESIS QUIMICA SA COMPANIA ESPANOLA DE SINTESIS QUIMICA SA CUTTER BIOL DIV MILES LABS INC BALENCO ENTERPRISES INC CUNO INC SUBJECT BETAMETHASONE SODIUM PHOSPHATE AS MFG. IN MADRID, SPAIN FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES CLOTRIMAZOLE AS MFG. IN CLAYTON, NC MAPROTILINE HYDROCHLORIDE USP AS MFG. IN COMPTON, CA

4Q2012

ZETA PLUS 50 LP MEDIA CARTRIDGES AND FLA STOCK MANUFACTURED INMERIDEN,CT ZETA PLUS 30 LP MEDIA CARTRIDGES AND FLA STOCK MANUFACTURED INMERIDEN,CT ZETA PLUS 60 SP MEDIA CARTRIDGES AND FLA STOCK MANUFACTURED INMERIDEN,CT

HIGH DENSITY POLYETHYLENE BOTTLES MANUFACTURED IN BROOKLYN, NEW YORK. HYDROCORTISONE HEMISUCCINATE AS MFG. IN MADRID, SPAIN ZETA PLUS 50 SP MEDIA CARTRIDGES AND FLA STOCK MFG. IN CT. ZETA PLUS 10 SP MEDIA CARTRIDGES AND FLA STOCK MFG. IN CT. PUSH-THRU FOIL AS MFG. IN ONTARIO, CANADA AMINOGUANIDINE HYDROCHLORIDE (W176-2) AS MFG. IN WISCONSIN ZETA PLUS 30 SP MEDIA CARTRIDGES AND FLA STOCK MFG. IN CT. CYCLOPENTOLATE HYDROCHLORIDE (P-637) AS MFG. IN CALIFORNIA

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4Q2012EXCEL DMF# 6760 I 6761 6762 I 6763 6764 6765 6766 6767 6768 6769 6770 I 6771 A 6772 6773 6774 6775 6776 I 6777 6778 6779 6780 6781 6782 6783 I 6784 6785 6786 6787 6788 6789 6790 I 6791 6792 6793 A I I II IV II 1/19/1987 1/14/1987 1/20/1987 CUNO INC PHARMACIA AB ZETA PLUS 60 CP MEDIA CARTRIDGES & FLA STOCK AS MFG. IN CT. SEPHADEX GEL FILTRATION MEDIA AS MFG. IN SWEDEN I I I I I A II II II IV II II II 1/19/1987 1/19/1987 1/8/1987 1/23/1987 1/27/1987 1/23/1987 1/19/1987 I A A I I I II II III II III II II 1/9/1987 1/9/1987 1/21/1987 1/15/1987 1/16/1987 1/19/1987 12/19/1986 I I I I II II I I II 1/13/1987 1/15/1987 1/15/1987 12/10/1986 1/12/1987 SELOC FRANCE PENCO OF LYNDHURST INC CHELSEA LABORATORIES INC ERCI FACILITIES SERVICES CORP INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA DINAMITE DIPHARMA SPA DIPHARMA FRANCIS SRL ALPHA PACKAGING PHARM ECO LABORATORIES INC MOBAY CHEMICAL CORP CUNO INC ORION CORPORATION FERMION OULU PLANT HOECHST AG CUNO INC QUATRUM SHIONOGI AND CO LTD PFIZER INC DOTTIKON EXCLUSIVE SYNTHESIS AG CUNO INC NIFEDIPINE AS MFG IN IRELAND METHOCARBAMOL MANUFACTURED IN NEW JERSEY. FACILITIES, PERSONNEL, & GENL OPERATING PROCEDURES IN NC. SOP'S FOR DRUG STORAGE AND DISTRIBUTION OF NCI DRUGS. THIOTHIXENE BASE AND HC1 AS MFG. IN MILAN, ITALY ISOSORBIDE-2-MONONITRATE (2-ISMN) AS MFG. IN ITALY. ISOSORBIDE-5-MONONITRATE (5-ISMN) AS MFG. IN ITALY. HDPE & LDPE BOTTLES AS MFG. IN ST. LOUIS, MO. N,N'-BIS (2-CHLOROETHYL)-N-NITROSOUREA (CARMUSTINE) MFG IN CA MERLON M 40(H)F-3291 MANUFACTURED IN BAYTOWN, TEXAS. II 1/15/1987 I I I I A I I II II III II II II II II 12/23/1986 1/5/1987 1/6/1987 1/7/1987 12/29/1986 1/9/1987 1/7/1987 10/6/1986 A II IV 1/5/1987 1/2/1987 STATUS Type SUBMIT DATE II 12/29/1986 HOLDER SUBJECT AYERST LABORATORIES INC DIV AMERICAN INTRANASAL INSULIN AS MFG. IN NEW YORK HOME PRODUCTS CORP CAMBREX PROFARMACO MILANO SRL DILTIAZEM HCL AS MFG. IN MILAN, ITALY GUANGZHOU PHARMACEUTICAL PACKAGING MATERIAL FACTORY SELOC AG ACF CHEMIEFARMA NV CONPLEX INC GE SILICONES MEDICHEM SA PENICK CORP GE SILICONES SUZHOU BIOCHEMICAL PHARMACEUTICAL MANUFACTURING CO BAYER PHARMA AG EMPTY HARD GELATIN CAPSULES AS MFG. IN PEOPLES REP. OF CHINA IMIPRAMINE PAMOATE AS MFG. BY SIFA LTD. IN IRELAND. IMIPRAMINE HYDROCHLORIDE AS MFG. IN MAARSSEN, HOLLAND THERMOPLASTIC SHEET AS MFG. IN FLORIDA BAYSILONE FLUID M 1000 S AS MFG IN GERMANY LOXAPINE SUCCINATE AS MFG IN GERONA, SPAIN OXYCODONE HYDROCHLORIDE AS MFG. IN NJ BAYSILONE ANTIFOAM100% DIMETHYLPOLYSILOXANE MFG IN GERMANY SODIUM HEPARIN.

4Q2012

CLOTRIMAZOLE (ESUB) MANUFACTURED IN ASTURIAS, SPAIN AND WUPPERTAL, GERMANY.

ZETA PLUS 01A MEDIA CARTRIDGES AND FLA STOCKMANUFACTURED INMERIDEN,CT TOLMETIN SODIUM AS MFG. IN FINLAND. CEFAZOLIN SODIUM INJECTION (STERILE FILLING), MFG. GERMANY. ZETA PLUS 30 CP MEDIA CARTRIDGES & FLA STOCK AS MFG. IN CT. HYDROCORTISONE ACETATE AS MFG. IN PORTUGAL. CAPSULES 7432-S AS MFG. IN JAPAN TRIAMCINOLONE 21-ACETATE AS MFG. IN MI. ISOSORBIDE-5-NITRATE-LACTOSE 20:80 BLEND MFG. IN SWITZERLAND. ZETA PLUS 70 CP MEDIA CARTRIDGES & FLA STOCK MANUFACTURED IN CONNECTICUT.

SOUTHWEST SYNTHETIC PHARMACEUTICAL SULFAMETHOXAZOLE USP AS MFG. IN PEOPLES REPUBLIC OF CHINA. CO LTD

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4Q2012EXCEL DMF# 6794 6795 A 6796 6797 I 6798 6799 I 6800 6801 6802 6803 6804 6805 6806 6807 6808 6809 6810 6811 6812 6813 6814 6815 6816 6817 6818 6819 6820 6821 6822 6823 6824 I 6825 6826 6827 6828 6829 6830 6831 I I A I I I I II I II IV II II III 2/13/1987 2/10/1987 2/13/1987 2/11/1987 2/19/1987 1/23/1987 2/23/1987 I I I I I I I I I I I I A I C I I A I I I A I I II II I II II II II IV II II II II II II II II II II II II III II I II V 2/2/1987 1/27/1987 1/30/1987 2/5/1987 2/2/1987 1/28/1987 2/2/1987 1/27/1987 2/4/1987 2/5/1987 1/19/1987 1/23/1987 1/19/1987 1/19/1987 1/23/1987 2/4/1987 1/19/1987 1/23/1987 2/11/1987 1/6/1987 2/4/1987 12/16/1986 2/12/1987 2/6/1987 2/10/1987 I II II 1/28/1987 1/30/1987 ANAQUEST INC WISCONSIN ANALYTICAL & RESEARCH SERVICES LTD IMHAUSEN CHEMIE GMBH KV PHARMACEUTICAL CO UCB BIOPRODUCTS SA GRAESSER LABORATORIES LTD UPJOHN CO RAYLO CHEMICALS SELOC AG PHARMACIA AB SANOFI CHEMIE SAPCHIM KYOWA HAKKO KOGYO CO LTD CUNO INC SOCIETA ITALIANA CORTICOSTEROIDI SPA CHEMINOVA AS CUNO INC TEVA PHARMACEUTICAL INDUSTRIES LTD SIBEFAT SPA CUNO INC TEVA PHARMACEUTICAL INDUSTRIES LTD ALTANA LOMBERG CHEMISCHE FABRIK KYOWA HAKKO KOGYO CO LTD WINN PACKAGING CO RELIANCE CELLULOSE PRODUCTS LTD ASTA PHARMA AG PENINSULA LABS SOUTH FLORIDA BIOAVAILABILITY CLINIC INC DIOSYNTH BV MEPHA AG LEK PHARMACEUTICALS DD EMERY CHEMICALS ELAN PHARMA LTD QUATRUM SPARTECH PLASTICS I II I 1/22/1987 1/26/1987 STATUS Type SUBMIT DATE I IV II 1/19/1987 1/20/1987 HOLDER PHARMACIA AB SUBJECT SEPHACRYL GEL FILTRATION MEDIA AS MFG. IN SWEDEN

4Q2012

SOUTHWEST SYNTHETIC PHARMACEUTICAL TRIMETHOPRIM USP MANUFACTURED IN PEOPLE'S REPUBLIC OF CHINA. CO LTD PURDUE UNIVERSITY 3,4-METHYLENEDIOXYMETHAMPHETAMINE MDMA AS MFG. IN INDIANA ORION CORP LTD MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MANKKAA PLANT. METHOXYFLURANE MANUFACTURED IN OHIO. ISOSORBIDE DINITRITE (ISDN), 2-ISMN AND 5-ISMN HALOPERIDOL MANUFACTURED IN LAHR, GERMANY. BROMPHENIRAMINE MALEATE/PHENYLPROPANOLAMINE C.R. TABLET FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES ISOSORBIDE-2-MONONITRATE AS MFG. IN THE UNITED KINGDOM U-62,840 AS MFG. IN KALAMAZOO, MICHIGAN 2',3'-DIDEOXYCYTIDINE AS MFG. IN CANADA IMIPRAMINE HYDROCHLORIDE AS MFG. BY SIFA LTD IN IRELAND SEPHADEX ION EXCHANGE MEDIA AS MFG. IN SWEDEN FLURAZEPAM HYDROCHLORIDE AS MFG. IN ARAMON, FRANCE ALPHA-MERCAPTOPROPIONYLGLYCINE AS MFG. IN JAPAN ZETA PLUS 50 CP MEDIA CARTRIDGES AND FLA STOCK FLUNISOLIDE AS MFG. IN MILAN, ITALY FYFANON TECHNICAL (ESUB) AS MANUFACTURED IN DENMARK ZETA PLUS 05 SP MEDIA CARTRIDGES AND FLA STOCK CLOBETASOL PROPIONATE AS MFG. IN MILAN, ITALY SODIUM CROMOGLYCATE AS MFG. IN ITALY ZETA PLUS 10 CP MEDIA CARTRIDGES AND FLA STOCK PANCURONIUM BROMIDE AS MFG. IN MILAN, ITALY THEOPHYLLINE SUSTAINED RELEASE CAPSULES (BY-158) DACARBAZINE AS MFG. IN JAPAN HIGH DENSITY POLYETHYLENE PLASTIC CONTAINERS MANUFACTURED IN OHIO. MICROCRYSTALLINE CELLULOSE AS MFG. IN INDIA PHARMACEUTICAL PRODUCTION PLANT IN KUNSEBECK, GERMANY D-ALA-8-THR-NH2 AS MFG. IN BELMONT, CALIFORNIA EFFECTS OF BIPERIDEN ON THE PHARMACOKINETICS OF HALOPERIDOL BETAMETHASONE MICRO AS MFG. IN HOLLAND FACILITIES, PERSONNEL AND GENERAL OPER. PROC. IN SWITZERLAND BROMOCRIPTINE MESYLATE USP AS MFG. IN MENGES, SLOVENIA EMERWAX 1266 EMULSIFYING WAX AS MFG. IN SOUTH CAROLINA NIFEDIPINE 50 MG. TABLETS AS MFG IN IRELAND METHYLPREDNISOLONE HEMISUCCINATE AS MFG. IN PORTUGAL COMPOSITE THERMOPLASTIC SHEET TYPE GTE/MTE/FTE MFG. IN MASS

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4Q2012EXCEL DMF# 6832 6833 6834 6835 6836 6837 6838 6839 6840 6841 6842 6843 6844 6845 6846 I 6847 6848 6849 6850 6851 6852 6853 6854 I 6855 6856 6857 6858 6859 6860 I 6861 6862 6863 6864 6865 6866 6867 6868 6869 6870 I A I I I I I A I A II II II III III III III II II II 3/13/1987 3/2/1987 3/10/1987 3/4/1987 3/4/1987 3/6/1987 3/4/1987 1/20/1987 3/5/1987 3/5/1987 A I I I I III II II II II II 3/10/1987 3/10/1987 3/9/1987 3/10/1987 3/13/1987 2/27/1987 BARNHARDT MANUFACTURING CO GANES CHEMICALS INC CAMBREX PROFARMACO MILANO SRL CUNO INC DIOSYNTH BV PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA DIOSYNTH BV DAITO PHARMACEUTICAL CO LTD CUNO INC HELVOET PHARMA ITALIA SPA HELVOET PHARMA ITALIA SPA TOP SEAL CORP HELVOET PHARMA ITALIA SPA FINORGA SAS ERREGIERRE SPA ERREGIERRE SPA I I I I I I A II II II II I III II I 3/6/1987 3/9/1987 2/26/1987 3/11/1987 2/27/1987 2/25/1987 3/10/1987 3/3/1987 STATUS Type SUBMIT DATE I I I I I I A A I I I A I I II III I II II III II III II II III II III II I 1/19/1987 2/24/1987 2/13/1987 2/23/1987 2/26/1987 2/23/1987 2/27/1987 3/6/1987 2/18/1987 2/18/1987 3/3/1987 3/3/1987 2/24/1987 2/26/1987 3/3/1987 HOLDER QUATRUM TECHNICAL PLASTIC EXTRUDERS INC SUPERIOR INC LABOCHIM ORGANICHEM CORP ALUMINUM COMPANY OF AMERICA TEVA PHARMACEUTICAL INDUSTRIES LTD HOSPIRA INC ORION CORP LTD ORION CORP LTD JAMES RIVER CORPORATION ALBEMARLE CORP WACHUSETT MOLDING CORP PHARM ECO LABORATORIES INC INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA DYNAMIT NOBEL AKTIENGESELLESCHAFT HOECHST MARION ROUSSEL SA PHARM ECO LABORATORIES INC FINE CHEMICALS CORPORATION CYANAMID GREAT BRITAIN LTD SILGAN PLASTICS CORP UCB PHARMA SA ORION CORP LTD SUBJECT METHYLPREDNISOLONE BASE MANUFACTURED IN PORTUGAL. PHARMACEUTICAL GRADE POLYVINYL CHLORIDE FILM AND SHEETING FACILITIES, PERSONNEL AND PROCEDURES IN FELTON, PA METAPROTERENOL SULFATE USP AS MFG. IN MILAN, ITALY AMINOBISAMIDE HYDROCHLORIDE AS MFG. IN NORTHUMBERLAND, ENGLAND PHAR 9423 AS MFG IN PITTSBURGH, PA METOPROLOL TARTRATE USP AS MFG. IN ISREAL ADD-VANTAGE FLEXIBLE DILUENT CONTAINER AS MFG. IN TX & IL PRAZOSIN HCL DELTA-FORM AS MFG. IN MANKKA, FINLAND PRAZOSIN HCL ALPHA-FORM AS MFG. IN MANKKA, FINLAND MANU OF CELESTRA X 1.00 LLP-T090 AND V090 NONWOVEN FABRICS IN WA. FENOPROFEN CALCIUM, USP+BP AS MFG. IN SOUTH HAVEN, MICHIGAN PACKAGING MATERIALS AS MFG. IN MASS. 2,6-DICHLORO-N-(4,5-DIHYDRO-IH-IMIDAZOL-2-YL)-1,4-BEZENEDIAMINE MONO FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN VARESE,ITALY NITROGLYCERIN 5% IN MIGLYOL 829 AS MFG. IN GERMANY TRIAMCINOLONE 21-ACETATE AS MFG. IN FRANCE XYLAZINE HYDROCHLORIDE MANUFACTURED IN SIMI VALLEY, CALIFORNIA. FLUPHENAZINE ENANTHATE AS MFG. IN SOUTH AFRICA FACILITY AT GOSPORT HANTS, ENGLAND PACKAGING MATERIALS MANUFACTURED IN LYONS, NEW YORK CETIRIZINE HYDROCHLORIDE AS MFG. IN BELGIUM MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FINLAND. PHARMACEUTICAL COIL PRODUCTS MANUFACTURED IN NORTH CAROLINA. DOXEPIN HYDROCHLORIDE MANUFACTURED IN NEW JERSEY. MECLOFENAMATE SODIUM AS MFG. IN ITALY 50 TSM MEDIA CARTRIDGES AS MFG. IN MERIDEN, CONNECTICUT STABILIZED ESTRONE SODIUM SULPHATE AS MFG. IN THE NETHERLANDS NIFEDIPINE MANUFACTURED IN ITALY. EQUILIN SODIUM SULPHATE STABILIZED AS MFG. IN THE NETHERLANDS . CLEMASTINE FUMARATE 100 TSM MEDIA CARTRIDGES AS MFG. IN MERIDEN, CONNECTICUT RUBBER STOPPERS IN GREY CHLOROBUTYL COMPOUND 464.04 RUBBER STOPPERS IN GREY BROMOBUTYL COMPOUND 544.04 INJECTION MOLDED CLOSURES MANUFACTURED A PHOENIX, ARIZONA. EPR COPOLYMER RUBBER COMPOUND 056.04 AS MFG. IN ITALY ESMOLOL HYDROCHLORIDE AS MFG. IN FRANCE ECONAZOLE NITRATE AS MFG. IN ITALY. MICONAZOLE NITRATE AS MFG. IN ITALY

4Q2012

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4Q2012EXCEL DMF# 6871 6872 6873 6874 6875 6876 6877 6878 6879 6880 6881 6882 I 6883 6884 6885 6886 6887 6888 6889 I 6890 6891 6892 6893 6894 A 6895 6896 I 6897 I 6898 6899 6900 I 6901 6902 6903 6904 6905 6906 I I I I I I I III III II II I 3/30/1987 4/2/1987 4/2/1987 4/3/1987 3/30/1987 3/31/1987 I I II II II 3/25/1987 3/31/1987 3/25/1987 I 4/1/1987 A II I 3/26/1987 2/28/1987 NOVARTIS PHARMA AG I I I I II IV II III V 3/27/1987 3/26/1987 3/25/1987 3/23/1987 3/16/1987 AMERSHAM CORP DOW CORNING CORP LONZA AG NORWOOD INDUSTRIES INC STERIGENICS US LLC I I A I A I II II II II II II I 3/18/1987 3/23/1987 1/20/1987 1/21/1987 3/16/1987 3/13/1987 3/25/1987 STATUS Type SUBMIT DATE I I I I A I A I I I I II II II II II III II II II II II II 3/13/1987 3/13/1987 3/16/1987 3/9/1987 3/19/1987 3/13/1987 3/6/1987 3/20/1987 3/10/1987 3/20/1987 3/23/1987 3/16/1987 HOLDER QUIMICA SINTETICA SA ZAMBON SPA HILLESTAD CORP SIBEFAT SPA KANEKA AMERICA CORP LLOYD MANUFACTURING COMPANY INC SEKISUI MEDICAL CO LTD DAIICHI PURE CHEMICALS CO LTD SANKYO CHEMICAL INDUSTRIES INC MOEHS SA DIV OF SANOF NOVA PHARMACEUTICAL CORP SUBJECT MECLOFENAMATE SODIUM USP AS MFG. IN SPAIN NAPROXEN USP MANUFACTURED IN ITALY. COUMARIN TABLETS 100 MG. MANUFACTURED IN SAN JOSE, CALIFORNIA. GEMFIBROZIL USP AS MFG. IN ITALY N-[1(S)-ETHOXYCARBONYL-3-PHENYLPROPYL]-L-ALANINE (ALE) GUM RUBBER FORMULATION #3141-71 MANUFACTURED IN RHODE ISLAND. CLEMASTINE FUMARATE MANUFACTURED IN JAPAN. MIX-RR MANUFACTURED IN TOKYO, JAPAN. FLAVOXATE HYDROCHLORIDE AS MFG. IN TOKYO, JAPAN. TRIMETHOPRIM AS MFG. IN SPAIN NPC-567 PRECLINICAL STUDIES & MFG. PROCEDURES IN BALTIMORE

4Q2012

PROSINTEX INDUSTRIE CHIMICHE ITALIANE MICONAZOLE NITRATE AS MFG. IN ITALY SRL SHIONOGI AND CO LTD COMPOUND 7432-S AS MFG. IN JAPAN LEO PHARMACEUTICAL PRODUCTS LTD CIPLA LTD CIPLA LTD MEDICHEM SA QUATRUM ICI PHARMACEUTICALS PR INC SODIUM TAURO-24,25-DIHYDROFUSIDATE BULK SUBSTANCE AS MFG. IN DENMARK ALBUTEROL SULFATE (ESUB) MANUFACTURED IN BOMBAY, INDIA. ALBUTEROL AS MFG IN BOMBAY, INDIA AMOXAPINE AS MFG. IN SPAIN METHYLPREDNISOLONE ACETATE AS MFG. IN PORTUGAL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CAROLINA, PUERTO RICO. IN-113M GENERATOR AS MFG. IN ENGLAND TRIMETHYLSILOXY ENDBLOCKED POLYMETHYLHYDROGEN SILOXANE L-CARNITINE (VIT. BT) AS MFG. IN SWITZERLAND NORWOOD KM-1392-00 AND IT'S COMPONENTS AS MFG. IN PA. STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN HAW RIVER, NC POLY (DL-LACTIDE-CO-GLYCOLIDE) MANUFACTURED IN SWITZERLAND.

HOVIONE MACAU SOCIEDADE QUIMICA LDA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MACAU. AUTOMATIC LIQUID PACKAGING MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WOODSTOCK, ILLINOIS. ISP SODIUM HYDROGEN VALPROATE AS MFG. IN CA ORION CORP FARMOS CHEMICAL PLANT METHOTREXATE 2,5 MG TABLET MANUFACTURED IN FINLAND. AMOCO CHEMS CORP AFFILIATE AMERICAN POLYARYLSULFONE RESIN RADEL A-400 OIL CO POYTHRESS & CO FACIL, PERSONNEL & CONTROLS A RICHMOND, VA BCL LTD BCL LTD BLASCHIM SPA ZENECA PHARMACEUTICALS QUIMICA SINTETICA SA REGENERATED CELLULOSE FILM AS MFG. IN SOMERSET, EMGLAND REGENERATED CELLULOSE FILM MANUFACTURED IN CUMBRIA, ENGLAND. FENOPROFEN CALCIUM MANUFACTURED IN MILANO, ITALY. ATENOLOL (ESUB) AS MANUFACTURED IN GERMANY FACIL, PERSONNEL AND GENL OPERATING PROCEDURES AT MADRID,SPAIN

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4Q2012EXCEL DMF# 6907 I 6908 6909 6910 6911 6912 6913 A 6914 6915 6916 6917 6918 I 6919 6920 I 6921 6922 6923 6924 6925 6926 I 6927 6928 6929 6930 A 6931 I 6932 6933 6934 6935 6936 6937 6938 6939 6940 6941 6942 I I I I A I I I I I I II II II III II II II II II II II 4/14/1987 4/2/1987 4/2/1987 4/13/1987 4/8/1987 4/15/1987 4/20/1987 4/20/1987 4/23/1987 4/20/1987 4/21/1987 CAMBREX PROFARMACO MILANO SRL DAIICHI PURE CHEMICALS CO LTD DAIICHI PURE CHEMICALS CO LTD BOCKO INC TEVA PHARMACEUTICAL INDUSTRIES LTD SANKYO CO LTD TOKUYAMA CORP HOFFMANN LA ROCHE INC SUMITOMO CHEMICAL CO LTD HOFFMANN LA ROCHE INC MILES INC I 4/15/1987 KNOLL AG I I A II I III II 4/3/1987 4/6/1987 4/15/1987 4/7/1987 I I I A I II II III II II II 4/10/1987 4/10/1987 4/3/1987 4/8/1987 4/14/1987 4/6/1987 I I II 4/9/1987 4/7/1987 C I I I II I III I II 4/9/1987 3/16/1987 3/4/1987 4/10/1987 4/7/1987 FINE CHEMICALS CORP PTY LTD PROCESS TECHNOLOGY INC BUNDER GLAS GMBH AL HIKMA PHARMACEUTICALS MERCK SHARP & DOHME RESEARCH LABS DIV MERCK & CO INC VOKES LTD MERCK SHARP & DOHME DIV MERCK & CO INC SIBEFAT SPA HEXAGON LABORATORIES INC COOPER FLEXIBLE PACKAGING, INC. MOEHS IBERICA SL ORION CORP FARMOS CHEMICAL PLANT BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG ETHYL CHEMICALS GROUPS GABRIEL CONSULTING INC CLP INDUSTRIES LTD MALLINCKRODT INC A I I I I II II II II I V 4/7/1987 4/3/1987 3/26/1987 4/8/1987 3/30/1987 3/16/1987 SIGMA ALDRICH IRELAND LTD ZEELAND CHEMICALS INC CIBA GEIGY LTD ZENECA PHARMACEUTICALS CELLTECH LTD STERIGENICS INTERNATIONAL STATUS Type SUBMIT DATE I 3/26/1987 HOLDER INJECTRONICS INC SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CLINTON, MA DOXYLAMINE SUCCINATE USP PARA-AMINOSALICYLIC ACID, SODIUM AS MFG. IN MICHIGAN CHLORTHALIDONE USP MANUFACTURED IN SWITZERLAND. ZESTRIL (LISINOPRIL) TABLETS AS MFG. IN DELAWARE

4Q2012

FACILITIES FOR PRODUCTION OF BULK RECOMBINANT HUMAN GROWTH HORMONE STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN SALEM, NEW JERSEY BENZTROPINE MESYLATE AS MFG. IN SOUTH AFRICA FACILITIES, PERSONNEL AND PROCEDURES IN WEST MEMPHIS, ARIZONA PACKAGING MATERIALS/BRONCHOLATOR AND RHINOLATOR AS MFG. IN GERMANY FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN AMMAN JORDON L-651,392-00N,4-BROMO-2,7-DIMETHOXY-3H-PHENOTHIAZIN-3-ONE FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN ENGLAND APRINOCID AS MFG IN NEW JERSEY AND ENGLAND ATENOLOL-MFG IN MILANO,ITALY(FORMERLY B.T.B. INDUSTRIA CHIMICA DEXCHLORPHENIRAMINE MALEATE AS MFG IN NEW YORK FLEXOGRAPHIC PRINTED INNERSEAL MATERIAL AS MFG IN ILLINOIS AMANTADINE HYDROCHLORIDE AS MFG IN SPAIN LEUCOVORIN CALCIUM 15MG TABLET AS MFG IN FINLAND DIGOXIN AS MANUFACTURED IN INGELHEIM AM RHEIN, GERMANY IBUPROFEN AS MFG IN ORANGEBURG, SOUTH CAROLINA FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN MASS FLEXIBLE PACKAGING MATERIALS MANUFACTURED IN ISRAEL OXYCODONE HYDROCHLORIDE USP (D) (ESUB) AS MANUFACTURED IN ST LOUIS MISSOURI MANUFACTURING SITE, FACILITES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MINDEN, GERMANY. FENOPROFEN CALCIUM MANUFACTURED IN MILAN, ITALY. L-VALINE AS MFG IN JAPAN L-PHENYLALANINE AS MFG IN JAPAN MANUFACTURE OF PLASTIC CONTAINERS FOR MEDICINE AMCINONIDE AS MFG IN MILAN ITALY CS-807 TABLETS AS MFG IN JAPAN HYDRALAZINE HYDRCHLORIDE AS MFG IN JAPAN PYRIDOSTIGMINE BROMIDE AS MFG IN NEW JERSEY CEFPIRAMIDE AS MFG IN JAPAN NEOSTIGMINE METHYLSULFATE AS MFG IN NEW JERSEY EX-CYTE I (BOVINE ORIGIN) GROWTH ENHANCEMENT MEDIA SUPPLEMENT

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4Q2012EXCEL DMF# 6943 6944 6945 I 6946 6947 6948 I 6949 6950 I 6951 6952 6953 I 6954 I 6955 6956 I 6957 I 6958 6959 6960 6961 6962 6963 6964 6965 I 6966 6967 6968 I 6969 6970 6971 6972 6973 6974 6975 I I I A I I I II II II II I I II 4/30/1987 4/14/1987 5/12/1987 5/13/1987 5/15/1987 5/2/1987 5/12/1987 DIAMALT AG NOVO NORDISK AS AVATAR CORP MALLINCKRODT INC PACO PHARMACEUTICAL SERVICES INC CONTRAPAK CORP MCGAW INC I A II II I 5/8/1987 5/8/1987 5/12/1987 SIGMA F AND D DIV LTD NORAMCO INC JOHNSON MATTHEY PLC I I I I I A I II I II II II III I I 4/30/1987 5/11/1987 5/8/1987 5/8/1987 5/8/1987 4/29/1987 4/28/1987 5/8/1987 I 4/30/1987 A II III 5/11/1987 5/4/1987 EUTICALS SPA BRISTOL-MYERS PRODS DIV BRISTOLMYERS CO SOUTH FLORIDA BIOAVAILABILITY CLINIC INC SOCIETA ITALIANA CORTICOSTEROIDI SPA POLI INDUSTRIA CHIMA SPA FARMABOIS FARMABOIS HEXAGON LABORATORIES INC SCANDIA PLASTICS INC FOREST LABORATORIES INC PARTICLE SIZE TECHNOLOGY INC I 4/16/1987 LABORATOIRES FOURNIER SA I I III II I 4/27/1987 4/16/1987 4/16/1987 HYGENIC CORP LABORATOIRES FOURNIER SA SYNKEM DIV PLASTO SA I III I 4/30/1987 4/28/1987 GEORGIA PACKAGING INC STELLA KG I A II II I 4/15/1987 4/7/1987 4/28/1987 STATUS Type SUBMIT DATE I I IV II I 4/21/1987 4/22/1987 4/24/1987 HOLDER MILES INC E MERCK SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP DR REDDY'S LABORATORIES LIMITED BK GIULINI GMBH STELLA KG SUBJECT EX-CYTE III (BOVINE ORIGIN) GROWTH ENHANCEMENT MEDIA SUPPLEMENT

4Q2012

SODIUM DIETHYLDITHIOCARBAMATE TRIHYDRATE-EXTRA PURE AS MFG IN GERMANY ANTI-INFECTIVE FACILITIES AT CONSHOHOKEN, PENNSYLVANIA ESTRADIOL AS MFG BY SYNTEX S.A IN MORELOS, MEXICO PHOSKADENT NA 211 (SODIUMMONOFLUOROPHOSPHATE) AS MFG IN GERMANY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ELTVILLE, GERMANY. 41737-30 PACKAGING MATERIAL AS MFG. IN COLUMBUS, GEORGIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KASTELLAUN, GERMANY. PROCESSING OF LATEX SHEETING FOR COMPOUND FORMULA TR200 FENOFIBRATE CAPSULES AS MFG IN FRANCE AND SWITZERLAND MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CHENOVE, FRANCE. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FONTAINE-LES-DIJON FRANCE. BROMOCRIPTINE MESYLATE AS MFG IN MILAN ITALY; PACKAGING MATERIALS DETERMINATION OF ERYTHROMYCIN IN HUMAN SERUM BY BIOLUMINOMETRY ASSAY TRIAMCINOLONE HEXACETONIDE AS MFG IN ITALY; FACILITIES PERSONNEL AND GENERAL OPERATING PROCEDURES IN MILAN, ITALY BETAMETHASONE 17 VALERATE AS MFG IN ITALY BETAMETHASONE AS MFG IN ITALY BENZPHETAMINE HYDROCHLORIDE AS MFG IN BRONX, NEW YORK HDPE PILL BOTTLES AS MFG IN SHEBOYGAN, WISCONSIN. FACILITIES AND PERSONNEL IN RIO PIEDRAS, PUERTO RICO MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PENNSYLVANIA. APOMORPHINE HCL AS MFG. IN SAINT LOUIS, MISSOURI. MORPHINE SULFATE AS MFG. IN WILMINGTON, DELAWARE MANUFACTURING SITE, FACILTIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN READING, ENGLAND ENCAINIDE HYDROCHLORIDE AS MFG IN GERMANY NORDITROPIN (BIOSYNTHETIC HUMAN GROWTH HORMONE, SOMAROPIN) SOYBEAN OIL, USP MANUFACTURED IN HICKORY HILLS, ILLINOIS. IOVERSOL (ESUB) AS MANUFACTURED IN ST. LOUIS, MISSOURI TRANSDERMAL MANUFACTURING FACILITY AT LAKEWOOD, NEW JERSEY CONTRACT PACKAGING FACILITY IN WAYNE, PENNSYLVANIA CYOCTOL PURIFIED AS MFG IN IRVINE, CALIFORNIA

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4Q2012EXCEL DMF# 6976 I 6977 6978 6979 A 6980 I 6981 6982 6983 6984 6985 6986 I 6987 I 6988 6989 A 6990 I 6991 6992 I 6993 6994 6995 6996 6997 6998 6999 7000 A 7001 7002 7003 7004 7005 7006 7007 7008 7009 I I I I I A I I I IV II I II II III II III I 6/1/1987 6/1/1987 6/4/1987 6/4/1987 5/29/1987 6/5/1987 6/8/1987 6/1/1987 6/4/1987 BORDEN INC GUANGZHOU PHARMACEUTICAL FACTORY FERRING GMBH FERRING GMBH SIBEFAT SPA EXXONMOBIL CHEMICAL CO DIOSYNTH BV GEORGIA PACKAGING INC ASSIA CHEMICAL INDUSTRIES LTD #8743P NATURAL AND ARTIFICIAL SPRAY DRIED FRUIT PUNCH FLAVOR LINCOMYCIN HCL MANUFACTURED IN PEOPLES REPUBLIC OF CHINA. FACILITIES AND OPERATING PROCEDURES IN GERMANY GONADORELIN ACETATE AS MFG IN GERMANY SULINDAC USP XXI AS MFG IN ITALY I I A A A I I I II IV IV II IV I II 5/27/1987 5/20/1987 5/22/1987 5/29/1987 5/22/1987 5/29/1987 5/29/1987 6/4/1987 3M PHARMS SIEGFRIED AG TEK PRODUCTS AND SERVICES INC WAKO PURE CHEMICAL INDUSTRIES LTD SIMS SRL GATTEFOSSE ESTABLISSEMENTS GRANUTEC INC ABBOTT LABORATORIES I II II 5/28/1987 5/28/1987 ROHM AND HAAS CO ELAN PHARM RES CORP I 5/27/1987 MEDEA RESEARCH LABS A II II 5/27/1987 5/29/1987 SANDOZ GMBH COPPERHEAD INVESTMENTS INC II 5/19/1987 ALCOLAC INC A A A I I II II II II I I 5/27/1987 5/27/1987 5/22/1987 5/8/1987 5/1/1987 5/26/1987 YUNG ZIP CHEMICAL IND CO LTD YUNG ZIP CHEMICAL IND CO LTD PCAS CHEMAPOL LTD TIM PLASTICS INC BAUSCH AND LOMB INC I 5/7/1987 I I II I II 4/10/1987 5/19/1987 5/5/1987 STATUS Type SUBMIT DATE II 5/5/1987 HOLDER NATL INST HLTH CONTRACEPTIVE DEV BRANCH MALLINCKRODT CHEMICAL INC PROGRAPHARM LABS SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL AMILCO CORP PR SUBJECT [D-TRP6, PRO9-NHET] GNRH OXYCODONE TEREPHTHALATE-D MANUFACTURED IN SAINT LOUIS,MISSOURI. FACILITES AND PERSONNEL AT CHATEAUNEUF-EN-THYMERAIS, FRANCE ATENOLOL AS MFG IN FIRENZE, ITALY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF GLASS CONTAINERS IN PUERTO RICO. DICLOFENAC SODIUM MANUFACTURED IN TAIWAN. MICONAZOLE NITRATE AS MFG. IN TAIWAN TIMOLOL MALEATE MANUFACTURED IN FINLAND.

4Q2012

BROMOCRIPTINE MESYLATE MANUFACTURED BY GALENA IN CZECHOSLOVAKIA. FACILITIES FOR MANUFACTURING HIGH DENSITY POLYETHYLENE BOTTLES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GREENVILLE, SOUTH CAROLINA. CHLORHEXIDINE GLUCONATE MANUFACTURED IN BALTIMORE AND SEDALIA, MARYLAND. SACA SODIUM SALT AS MFG IN AUSTRIA SDM 77 (10% NITROGLYCERIN IN SOLVATED ACRYLATE BASED ADHESIVE) MANUFACTURED IN TAMAQUA, PA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PORT JEFFERSON STATION, NEW YORK. BIOCRYL BPA-5050PMN MANUFACTURED IN BRISTOL, PENNSYLVANIA. THEOPHYLLINE CONTROLLED RELEASE BEADS MANUFACTURED IN GAINESVILLE, GEORGIA. FACILITIES FOR MFG OF TRANSDERMAL DELIVERY DRUG PRODUCTS PHENPROBAMATE AS MFG IN SWITZERLAND IMPRINTING INKS FOR MARKING PHARMACEUTICAL DOSAGE FORMS COPOLY (DL-LACTIC ACID/GLYCOLIC ACID) MANUFACTURED IN JAPAN. KETOPROFEN MANUFACTURED IN ITALY. SUPERPOLYSTATE MANUFACTURED IN FRANCE. FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN NC VERAPAMIL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN LIESTAL, SWITZERLAND

LOW DENSITY POLYETHYLENE AND ETHYLENE-VINYL ACETATE COPOLYMERS 17-ALPHA DIHYDROEQUILIN SODIUM SULPHATE 41132-22 PACKAGING MATERIAL AS MFG. IN GEORGIA FACILITIES AND PERSONNEL IN PETAH TIKVA, ISRAEL

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4Q2012EXCEL DMF# 7010 7011 7012 7013 7014 7015 7016 7017 7018 I 7019 7020 7021 7022 7023 7024 7025 7026 7027 7028 7029 7030 7031 7032 7033 7034 7035 7036 7037 7038 7039 7040 7041 7042 7043 I 7044 7045 7046 7047 7048 A I A I I III III II II II 6/30/1987 6/30/1987 7/7/1987 6/29/1987 7/9/1987 WADDINGTON JAYCARE LTD COPE ALLMAN JAYCARE LTD RELIABLE CHEMICAL CO MALLINCKRODT INC GLAXOSMITHKLINE LLC DBA GLAXOSMITHKLINE I I I I I I I I A I I I A I A I I I I I I I I I II II II III II II II I IV IV I I II II II II IV II II II II II II II I 6/15/1987 6/15/1987 6/9/1987 6/9/1987 6/15/1987 6/18/1987 6/18/1987 6/15/1987 6/17/1987 6/15/1987 6/23/1987 6/18/1987 6/22/1987 6/17/1987 6/18/1987 6/16/1987 6/29/1987 6/26/1987 6/22/1987 7/1/1987 6/24/1987 6/24/1987 6/30/1987 6/29/1987 6/30/1987 STATUS Type SUBMIT DATE I I I I I I I A II II II II I I II II II 5/13/1987 6/9/1987 6/9/1987 6/2/1987 6/9/1987 6/10/1987 6/10/1987 6/15/1987 6/10/1987 HOLDER JVL CORP DIOSYNTH BV DIOSYNTH BV ALDRICH CHEMICAL COMPANY INC ORGANON INC INPHARZAM SA SUMIKA FINE CHEMICALS CO LTD STREM CHEMICALS INC SUBJECT METAPROTERENOL SULFATE AS MFG IN GERMANY. HYDROMORPHONE HYDROCHLORIDE AS MFG. IN THE NETHERLANDS MEGESTROL ACETATE FROM GRANULATE AMMONIUM TETRATHIOMOLYBATE AS MFG. IN MILWAUKEE, WISCONSIN FACIL, PERSONNEL AND OPER. PROCEDURES AT WEST ORANGE, NJ FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN SWITZERLAND TRAZODONE HYDROCHLORIDE AS MFG IN GIFU PREFECTURE, JAPAN CIS-PLATIN AS MFG IN NEWBURYPORT, MASS.

4Q2012

ABBOTT LABORATORIES PHARMACEUTICAL MAPROTILINE HYDROCHLORIDE AS MFG IN CHICAGO IL PRODUCTS DIV ROHM AND HAAS CO AMBERLITE IRA-68 AS MFG IN ENGLAND ROHM AND HAAS CO TAKEDA PHARMACEUTICAL CO LTD ALCAN RORSCHACH AG ROHM AND HAAS CO FDC PRIVATE LTD FDC PRIVATE LTD APOTEX INC DOW CORNING CORP UNGERER AND CO BIOCHEMIC GESELLSCHAFT MBH LEJUS PHARMACEUTICAL PRODUCT LUNDBECK PHARMACEUTICALS ITALY SPA EURAND AMERICA INC DR REDDYS LABORATORIES LTD COSMA SPA RELIABLE CHEMICAL CO FARMABOIS BIOTECHNOLOGY GENERAL CORP QUATRUM ERREGIERRE SPA ERREGIERRE SPA FARMOS GROUP LTD MEDIPOLAR GIST-BROCADES NV WADDINGTON JAYCARE LTD AMBERLITE IR-120 AS MFG IN PHILADELPHIA, PA LUPRON DEPOT AND LUPRON DEPOT VEHICLE AS MFG IN JAPAN COMPOSITION AND MANUFACTURING PROCEDURES OF PACKAGING MATERIALS AMBERLITE IRA-958 AS MFG IN PENNSYLVANIA METRONIDAZOLE U.S.P. XXI AS MFG IN INDIA DIAZEPAM U.S.P. XXI AS MFG IN INDIA FACILITIES, PERSONNEL AND CONTROLS IN WESTON, ONTARIO BIO-PSA MEDICAL GRADE SILICONE ADHESIVE XCF7-4354, QCF7-4354,XCF7-3355 ARTIFICIAL BITTERMASKING FLAVOR #14078 MANUFACTURE OF PENICILLIN PRODUCTS IN KUNDL, AUSTRIA FACILITIES, PERSONNEL AND PROCEDURES IN MOLNDAL, SWEDEN DIAZOXIDE MANUFACTURED IN PADOVA, ITALY. PRAZOSIN HYDROCHLORIDE CONTROLLED RELEASE TABLETS BENZTROPINE MESYLATE ACETOHEXAMIDE AS MFG IN CISERANO, ITALY. POLYHESIVE PBS SYRUPS AS MFG IN ST LOUIS, MISSOURI. BETAMETHASONE 17,21 DIPROPIONATE AS MFG IN GROPELLO CAIROLI ITALY RECOMBINANT HUMAN GROWTH HORMONE BETAMETHASONE BASE AS MFG. IN SACAVEM, PORTUGAL ECONAZOLE BASE MANUFACTURED IN SAN PAOLO D'ARGON, ITALY. MICONAZOLE BASE AS MFG. IN SAN PAOLO D'ARGON, ITALY FENOPROFEN CALCIUM AS MFG. IN OULU, FINLAND 6-APA AS MFG. IN STRANGAS, SWEDEN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF INJECTION MOULDED PLASTIC PACKAGING TRACER PACK AS MFG. IN LONDON, ENGLAND SECURITAINERS, SECURITAINER CAPS AND JAYFILLA PHOSPHATE BUFFERED SALINE (PBS) POLYHESIVE HYDROCORTISONE SYRUP ACETOXYACETYL CHLORIDE AS MFG. IN ST. LOUIS, MISSOURI CLAVULANATE POTASSIUM AS MFG. IN AYSHIRE, SCOTLAND

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4Q2012EXCEL DMF# 7049 7050 7051 7052 7053 7054 7055 7056 7057 I 7058 7059 7060 I 7061 7062 I 7063 7064 7065 7066 7067 7068 7069 7070 7071 7072 7073 7074 7075 7076 7077 7078 7079 7080 7081 7082 I 7083 I 7084 I II 7/20/1987 EI DUPONT DE NEMOURS AND CO IRON-59 AS FERRIC CHLORIDE AND FERROUS CITRATE MFG IN MA II 7/27/1987 HUHTAMAKI OY LEIRAS PHARMACEUTICALS SALBUTAMOL BASE BULK AS MFG IN TURKU, FINLAND I I I I I I I I I I I I I I A A I I I II II II I II IV IV II II I II II II II II II II II I II 6/22/1987 6/22/1987 7/13/1987 7/15/1987 7/20/1987 7/17/1987 7/9/1987 7/14/1987 7/13/1987 7/20/1987 7/15/1987 6/30/1987 7/20/1987 7/13/1987 7/14/1987 7/24/1987 7/20/1987 6/25/1987 7/10/1987 6/15/1987 I II I 7/17/1987 7/17/1987 EGIS PHARMACEUTICALS I I V II I 11/26/1986 7/17/1987 7/6/1987 CHEMINOVA AS EGIS PHARMACEUTICALS ECOLOCHEM, INC STATUS Type SUBMIT DATE I A I I A I I I II II II I II II II II I 7/8/1987 7/6/1987 7/2/1987 7/7/1987 7/3/1987 6/18/1987 7/7/1987 6/29/1987 7/14/1987 HOLDER QUATRUM MALLINCKRODT INC MALLINCKRODT CHEMICAL INC ASTA PHARMA AG SHASUN PHARMACEUTICALS LTD CUNO INC INTERFALK US INC MALLINCKRODT INC DANBURY PHARMACAL INC SUBJECT BETAMETHASONE VALERATE AS MFG. IN SACAVEM, PORTUGAL

4Q2012

INDIUM CHLORIDE IN-111 (ESUB) AS MANUFACTURED. IN MARYLAND HEIGHTS, MO FENTANYL CITRATE USP AS MFG. IN ST. LOUIS, MISSOURI PRODUCTION OF DRUG SUBSTANCES AT THE BIELEFELD PLANT,GERMANY IBUPROFEN USP AS MFG. IN PONDICHERRY, INDIA MANUFACTURE OF ZETAPREP DEAE MODULAR CARTRIDGES IN CONN. URSODEOXYCHOLIC ACID 250 MG TABLETS ACETOXYACETYL CHLORIDE AS MFG. IN RALEIGH, NC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CARMEL, NEW YORK. HAZARD EVALUATION: HUMAN & DOMESTIC ANIMALS AMITRIPTYLINE HYDROCHLORIDE AS MFG IN BUDAPEST, HUNGARY MANFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF WATER TREAMENT IN FONTANA, CALIFORNIA, HOUSTON, TEXAS, AND ST. LOUIS, MISSOURI. PERPHENAZIN BASE AS MFG IN BUDAPEST, HUNGARY

YAMANOUCHI PHARMACEUTICAL COMPANY FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN SHIZUOKA-KEN LTD NIPPON KAYAKU COMPANY LTD CARBIDOPA AS MFG IN TOKYO, JAPAN NIPPON KAYAKU COMPANY LTD PHARM ECO LABORATORIES INC SIEGFRIED AG RELIABLE CHEMICAL CO PIERCE CHEM CO MISSION PHARMACAL CO H REISMAN CORP TAKEDA PHARMACEUTICAL CO LTD BIOCHEMIC GESELLSCHAFT MBH EI DUPONT DE NEMOURS AND CO B BRAUN MEDICAL INC MALLINCKRODT CHEMICAL INC JT BAKER CHEMICAL CO PCAS NORAMCO INC SIGMA F AND D DIV LTD SPOFA UNITED PHARM WORKS LABORATORI GUIDOTTI SPA SULINDAC AS MFG IN TOKYO, JAPAN PRALIDOXIME CHLORIDE USP AS MFG IN SIMI VALLEY, CALIFORNIA FACILITIES, EQUIPMENT AND OPERATING CONTROLS IN ZOFINGEN, SWITZERLAND PHOSPHATE BUFFER SALINE (PBS) POLYHESIVE HYDROCORTISONE ACETATE SYRUP DETOXI-GEL ENDOTOXIN REMOVING GEL FOR THE MANU OF DRUGS & DRUG PRODUCT SODIUM CELLULOSE PHOSPHATE AS MFG. IN SAN ANTONIO, TEXAS PSEUDOEPHEDRINE HYDROCHLORIDE AS MFG. IN ORANGE, NEW JERSEY HYDROMORPHONE HYDROCHLORIDE AS MFG. IN NEWARK, NEW JERSEY STERILE PRECIPITATION PLANT IN KUNDL, TYROL, AUSTRIA RECOMBINANT INTERLEUKIN-2, HUMAN (RIL-) MFG IN DELAWARE HYDROXYETHYL STARCH MANUFACTURED IN SABANA GRANDE, PR IBUPROFEN DCI-63 AS MFG. BY GLAT AIR TECHNIQUES, INC. IN RAMSEY, N.J. DOXYLAMINE SUCCINATE AS MFG. IN PHILLIPSBURG, NEW JERSEY BACLOFEN AS MFG. IN IN TURKU, FINLAND HYDROCODONE BITARTRATE AS MFG. IN WILMINGTON, DELAWARE OROTIC ACID AS MFG IN ST. LOUIS, MO TERGURIDE AS MFG BY GALENA, N.P. IN CZECHOSLOVAKIA FACIL, PERSONNEL & GENL OPERATING PROCEDURES IN PISA, ITALY

HUHTAMAKI OY LEIRAS PHARMACEUTICALS SALBUTAMOL SULFATE BULK MANUFACTURED IN TURKU, FINLAND.

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4Q2012EXCEL DMF# 7085 7086 A 7087 7088 7089 7090 7091 7092 7093 7094 7095 7096 7097 7098 7099 7100 7101 7102 I 7103 7104 I 7105 7106 7107 I 7108 7109 7110 7111 I 7112 I 7113 7114 A 7115 7116 I 7117 7118 I I I II 8/18/1987 8/20/1987 RORER PHARM CORP ALLIED SIGNAL INC A II III 8/24/1987 8/19/1987 SANDOZ GMBH COURTESY MEDTEK I III IV 8/14/1987 8/17/1987 II 4/30/1987 RP SCHERER NORTH AMERICA DIV RP SCHERER CORP POLYCON INDUSTRIES INC DOW CORNING CORP I I A II II II I 8/11/1987 8/11/1987 8/18/1987 8/17/1987 A A V III II 7/27/1987 8/14/1987 8/10/1987 PHARMACIA AND UPJOHN SUB PFIZER INC MULTISORB TECHNOLOGIES INC WISCONSIN ANALYTICAL & RESEARCH SERVICES LTD 3M PHARMS HUNTINGTON LABS INC SANDOZ GMBH MYLAN INC I II I 8/10/1987 8/6/1987 ASHOK ORGANIC INDUSTRIES LTD WARNER LAMBERT CO I I I A I A I A I A I I A I I III II II II I III I II II II I I II II II I 7/27/1987 7/24/1987 7/29/1987 7/28/1987 7/28/1987 7/31/1987 8/7/1987 8/4/1987 8/4/1987 8/4/1987 8/7/1987 8/7/1987 8/6/1987 8/4/1987 8/6/1987 8/7/1987 HERCULES INC LABOCHIM NIPPON GOHSEI CO LTD NORDMARK ARZNEIMITTEL GMBH CO KG KNOLL AG MULTISORB TECHNOLOGIES INC RORER PHARM CORP SUB RORER GROUP CAMBREX PROFARMACO MILANO SRL PHARMACIA AND UPJOHN SUB PFIZER INC SIFAVITOR SRL ALCAN FOLIEN GMBH ADVANCED MAGNETICS INC NV ORGANON 3M PHARMS ASTRAZENECA PHARMACEUTICALS LP FDC PRIVATE LTD NC-603R POLYPROPYLENE RESIN AS MFG IN WILMINGTON, DELAWARE BROMOCRIPTINE MESYLATE AS MFG IN MILAN, ITALY ALUMINUM SUCROSE SULFATE AS MFG IN KUMAMOTO JAPAN PANCRELIPASE AS MFG. IN UETERSEN, GERMANY NORDMARK PHARMACEUTICAL PROD. FACIL. IN UETERSEN, W. GERMANY MINIPAX DESSICANT PACKETS MANUFACTURED IN BUFFALO, NEW YORK. FACILITIES, PERSONNEL AND PROCEDURES IN FORT WASHINGTON, PA ALPRAZOLAM AS MFG. IN MILAN, ITALY BETAMETHASONE DIPROPIONATE AS MFG. IN KALAMAZOO, MICHIGAN MAPROTILINE HYDROCHLORIDE AS MFG. IN MILAN, ITALY FACILITIES FOR THE MFG. OF PACKAGING MATERIALS IN GERMANY FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN CAMBRIDGE,MA BUPRENORPHINE HYDROCHLORIDE AS MFG. IN OSS HOLLAND METHENAMINE HIPPURATE AS MFG. IN THE UK ATENOLOL ACETATE (ESUB) AS MANUFACTURED IN THE UNITED KINGDOM STATUS Type SUBMIT DATE I III IV 7/28/1987 7/28/1987 HOLDER GRAPHIC PACKAGING CORP SUBJECT PRINTED & LAMIN ROLL STOCK FLEXIBLE PACK MATL & PREF BAGS -

4Q2012

VERTELLUS PERFORMANCE MATERIALS INC TRIETHYL CITRATE FCC AS MFG IN GREENSBORO, NORTH CAROLINA;

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MAHARASHTRA STATE, INDIA. MICROCRYSTALLINE CELLULOSE POWDER MANUFACTURED IN NANDESARI, INDIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BROCKVILLE, ONTARIO, CANADA. STERILE AND NON-STERILE MFG FACILITIES IN PUURS, BELGIUM DRICAP MANUFACTURED IN BUFFALO, NEW YORK. DETERMINATION OF PSEUDOEPHEDRINE IN HUMAN PLASMA ORPHENADRINE CITRATE AS MFG. IN LEICESTERSHIRE, ENGLAND 20% CHLORHEXIDINE GLUCONATE AS MFG IN HUNTINGTON, INDIANA LIOTHYRONINE SODIUM AS MFG IN TYROL, AUSTRIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PUERTO RICO. MCN-5691 AS MFG IN ST. PETERSBURG, FL PLASTIC BOTTLES AS MFG IN MERRILLVILLE, INDIANA DOW CORNING R BIOPSA AMINE-COMPATATIBLE SILICONE ADHESIVE MANUFACTURED IN HEMLOCK, MI CTAZ-TBE (CEFTAZIDIME-TERT.-BUTYLESTER) AS MFG IN KUNDL, AUSTRIA PACKAGING FOR HUMAN DRUGS AND BIOLOGICS MANUFACTURED INWHEELING ILLINOIS FACILITIES, PERSONNEL AND PROCEDURES IN MANATI, PUERTO RICO FLUOROCARBON AS MFG. IN BUFFALO, NEW YORK

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4Q2012EXCEL DMF# 7119 I 7120 7121 7122 7123 7124 7125 7126 7127 7128 7129 7130 7131 A 7132 7133 7134 7135 7136 7137 7138 I 7139 I 7140 7141 7142 7143 7144 I 7145 7146 7147 7148 7149 7150 I 7151 7152 7153 7154 C I I I II II II II 9/22/1987 9/24/1987 9/24/1987 9/25/1987 TEVA PHARMACEUTICAL INDUSTRIES LTD FRANCIS SPA SYLATEC GROUPE SYNTHELABO SUMITOMO CHEMICAL CO LTD A I I I I II II II I IV I 9/17/1987 9/8/1987 9/17/1987 9/16/1987 9/14/1987 9/17/1987 I I I I III II II II I 9/14/1987 9/14/1987 9/3/1987 9/10/1987 9/14/1987 II 9/10/1987 I A I I I I II II I II I II II 9/4/1987 9/4/1987 8/31/1987 8/31/1987 8/31/1987 9/4/1987 9/4/1987 I I I I I I I I I A I II II II III II II II II I III II II 8/27/1987 8/26/1987 8/24/1987 8/25/1987 8/27/1987 8/31/1987 8/21/1987 8/17/1987 8/28/1987 9/3/1987 8/25/1987 9/4/1987 ISOCHEM SA SCHERING AG BACHEM FEINCHEMIKALIEN AG NORTON PERFORMANCE PLASTICS TANABE SEIYAKU CO LTD QUATRUM AVATAR CORP IFP INC WARNER LAMBERT CO DAIICHI GLASS CO LTD FABBRICA ITALIANI SINTETICI SPA STATUS Type SUBMIT DATE II 8/28/1987 HOLDER FOREST LABORATORIES INC SUBJECT

4Q2012

SODIUM MONOFLUOROPHOSPHATE 76 MG. C.R. TABLETS MANUFACTURED IN INWOOD, NEW YORK. FENOPROFEN CALCIUM USP AS MFG. IN PITHIVIERS AND GENNEVILLIERS, FRANCE PANCURONIUM BROMIDE AS MFG. IN BERGKAMEN, GERMANY BOC-THR(BZL)-D-GLU(OBZL)-NH2 AS MFG. IN BUBENDORF, SWITZERLAND TFE/PU LAMINATE AS MFG. IN GRANVILLE, N.Y AND WAYNE, N.J. TA-3090 AS MFG. IN OSAKA, JAPAN BETAMETHASONE DIPROPIONATE MANUFACTURED IN SACAVEM, PORTUGAL. SAFFLOWER OIL AS MFG. IN HICKORY HILLS, ILLINOIS SULFASALAZINE STARCH POWDER AS MFG. IN HAYFIELD, MINNESOTA MANUFACTURING FACILITY IN PONTYPOOL, GWENT, UNITED KINGDOM GLASS BOTTLES AS MFG. IN TOKYO, JAPAN PIROXICAM AS MFG. IN VICENZA, ITALY

NOBEL CHEMICALS AB DIV FINE CHEMICALS NAPROXEN SODIUM USP AS MFG. IN MILAN, ITALY INC ALCHYMARS TRANYLCYPROMINE SULFATE USP MANUFACTURED IN MILAN, ITALY. BLASCHIM SPA ERCI FACILITIES SERVICES CORP RALLIS INDIA LTD CHEMAPOL LTD DELMAR CHEMICALS INC EXTAL PTY LTD DIV JOHNSON AND JOHNSON ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV NAN YA PLASTICS CORPORATION USA ZENECA PHARMACEUTICALS UNILEVER UNITED STATES INC BACHEM FEINCHEMIKALIEN AG STROLLE RESEARCH & DEVELOPMENT CORP JOHNSON MATTHEY INC LUSOCHIMICA S P A PFANSTIEHL LABORATORIES INC VIS FARMACEUTICA ALDRICH CHEMICAL COMPANY INC SEKISUI CHEMICAL COMPANY LTD ATENOLOL AS MFG. IN MILAN, ITALY FACILITIES IN ROCKVILLE, MD FOR STORAGE-NCI CONTRACT #N01-CN-65002 NAPROXEN AS MFG. IN GUJARA, INDIA GALENA N.P., A CO. OF SPOFA-FACILITIES, OPAVA-KOMAROV, CZECHOSLOVAKIA TACRINE HYDROCHLORIDE MONOHYDRATE AS MFG. QUEBEC, CANADA NALOXONE HYDROCHLORIDE AS MFG. IN WESTBURY, TASMANIA, AUSTRALIA TUBOCURARINE CHLORIDE AS MFG. IN NORTH CHICAGO, ILLINOIS XAH FILM AND SHEET MATERIAL AS MFG. IN WHARTON, TEXAS LISINOPRIL DIHYDRATE AS MFG. IN CHESHIRE, ENGLAND ENCAPSULATED CALCIUM CARBONATE MFG. IN JOLIET & CHICAGO, IL. MANUFACTURE OF ANARITIDE ACETATE IN BUBENDORF, SWITZERLAND FACILITIES AND PROCEDURES IN CINCINNATI, OHIO CARBOPLATIN PRODUCTION AND CONTROL METHODS FOR THE MFG. OF NIFEDIPINE L-RHAMNOSE AS MFG. IN WAUKEGAN, ILLINOIS FACILITIES, PERSONNEL AND CONTROLS IN PADOVA ROSE BENGAL AS MFG. IN MILWAUKEE, WISCONSIN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN YAMAGUCHI, JAPAN. METOPROLOL TARTRATE AS MFG. IN MILAN, ITALY FENOPROFEN CALCIUM AS MFG. IN CARONNO PERTUSELLA, ITALY KETO ACID MIXTURE EE FORMULA MB 235G06 PRAZOSIN HYDROCHLORIDE AS MFG. IN GIFU PREFECTURE & OSAKA, JAPAN

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4Q2012EXCEL DMF# 7155 7156 7157 7158 7159 A 7160 7161 7162 7163 I 7164 7165 7166 7167 7168 7169 7170 7171 7172 7173 7174 7175 7176 7177 7178 7179 7180 7181 7182 I 7183 7184 7185 I 7186 7187 7188 7189 7190 7191 7192 I A A I I I I II II II II II III II 11/3/1987 8/17/1987 10/13/1987 10/20/1987 10/18/1987 10/16/1987 10/19/1987 ISTITUTO CHEMICOTHERAPICO ITALIANO AVANTI POLAR LIPIDS INC PCAS INNOVATIVE FOOD PROCESSORS INC ARCHIMICA SPA PHARMA ELASTOMERE RAYLO CHEMICALS I I II V I 10/14/1987 10/12/1987 10/16/1987 I I I I I I A A I I I I I I I I I I I II IV I II II IV II II IV II II III II II II III I I 9/25/1987 9/25/1987 9/23/1987 9/22/1987 10/5/1987 9/14/1987 10/2/1987 10/12/1987 9/14/1987 10/5/1987 10/12/1987 10/13/1987 10/8/1987 10/2/1987 10/6/1987 10/8/1987 10/9/1987 10/9/1987 10/9/1987 I A I II II V II 9/25/1987 9/25/1987 9/30/1987 10/8/1987 STATUS Type SUBMIT DATE A I I I III II II II V 9/1/1987 9/29/1987 9/25/1987 9/23/1987 9/29/1987 HOLDER DAIKYO SEIKO LTD EZ PAP INC GD SEARLE PHARMACEUTICALS INC PFANSTIEHL LABORATORIES INC SUBJECT PHARMACEUTICAL RUBBER ITEMS MANUFACTURED IN TOCHIGI, JAPAN. DIRECTLY COMPRESSIBLE ACETAMINOPHEN 73% (E-Z 180) MFG. IN NJ HALOPERIDOL AS MFG. IN NORTHUMBERLAND, ENG. & CAGUAS, P.R. UREA PEROXIDE, U-102 AS MFG. IN WAUKEGAN, ILLINOIS

4Q2012

NATIONAL INSTITUTES HEALTH NATIONAL CURRICULUM VITAES INSTITUTE ALLERGY INFECTIOUS DISEASES NISSEI CHEMICAL INDUSTRY COMPANY LTD FACILITIES, PRODUCTION AND CONTROLS FOR MFG. OF SUCRALFATE SA AJINOMOTO OMNICHEM NV VETTER PHARMA FERTIGUNG GMBH SHANGHAI NO 2 PHARMACEUTICAL FACTORY HOECHST ITALIA SUD SPA SIGMA F AND D DIV LTD FELTON WORLDWIDE INC ABLE MANUFACTURING CORP HOSPIRA PENNISULA LABORATORIES INC LUBRIZOL ADVANCED MATERIALS INC CIPLA LTD PENINSULA LABS STERLING ORGANICS CIPLA LTD PRODESFARMA QUIMICA SL MULTISORB TECHNOLOGIES, INC NAPP TECHNOLOGIES INC ERREGIERRE SPA TEIKOKU CHEM INDUSTRY NUODEX INC PFIZER CENTRAL RESEARCH AMSA ANONIMA MEDICINALI SINTETICI & AFFINI SPA WYCKOFF CHEMICAL CO INC GIVAUDAN CORPORATION FISONS CORP PRAZOSIN HYDROCHLORIDE AS MFG. IN WETTEREN, BELGIUM PREPARATION OF PRE-FILLED SYRINGES, MFG. IN RAVENSBURG, W.G. CARBAMAZEPINE AS MFG. IN SHANGHAI, CHINA STERILE POWDER FILLING OF STERILE CEPHALOSPORINS-SCOPPITO,ITAL CORTICOSTERONE AS MFG. IN ST. LOUIS, MISSOURI ARTIFICIAL TOASTED COCONUT FLAVOR #1323 P.G. FACILITIES, PERSONNEL & PROCEDURES IN VEGA ALTA, PUERTO RICO INTRAVENOUS FA EMULSION PRODUCT 4501 AS MFG. STOCKHOLM, SWE. SALMON CALCITONIN AS MFG. IN BELMONT, CALIFORNIA CARBOPOL 974P AND 971P AS MFG. AT CALVERT CITY, KENTUCKY MEBENDAZOLE USP (ESUB) AS MANUFACTURED. IN INDIA DYNORPHIN A (1-13, PORCINE) AS MFG. IN BELMONT, CA MACROSORB TYPE I MATERIALS AS MFG. IN ENGLAND PROPANALOL HYDROCHLORIDE AS MFG. IN INDIA ATENOLOL AS MFG. IN BARCELONA, SPAIN DRICAP PLUS AS MFG. IN BUFFALO, NEW YORK SULFAMETHOXAZOLE MANUFACTURIED IN LODI, NEW JERSEY. METOPROLOL BASE AS MFG. IN SAN PAOLO D'ARGON, ITALY. FLUOROURACIL AS MFG. IN OSAKA, JAPAN ADMEX 760 POLYMERIC PLASTICIZER AS MFG. IN CHESTERTOWN, MD FACILITIES, PERSONNEL & EQUIPMENT IN SANDWICH, KENT, ENGLAND MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MILANO, ITALY. DOXAPRAM HYDROCHLORIDE MANUFACTURED IN SOUTH HAVEN, MICHIGAN. CLINICAL STUDIES REGARDING THE USE OF PARSOL MCX MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES SUCRALFATE MANUFACTUED IN SAN GRATO DI LODI, ITALY. 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOCHOLINE MANUFACTURED IN ALABAMA. PINDOLOL MANUFACTURED IN LIMAY, FRANCE. DIETHYLCARBAMAZINE CITRATE AS MFG. IN HAYFIELD, MINNESOTA IMIPRAMINE HYDROCHLORIDE AS MFG. IN ORRIGIO, ITALY RUBBER PARTS PHE 401/60 GREY AS MFG. IN SIMMERAH, W. GERM. MFG. METHODS AND PROPERTIES OF 2'-3'-DIDEOXYADENOSINE

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4Q2012EXCEL DMF# 7193 7194 7195 7196 I 7197 7198 I 7199 7200 7201 7202 7203 I 7204 7205 I 7206 7207 7208 7209 7210 I 7211 7212 7213 7214 7215 7216 7217 7218 7219 I 7220 7221 7222 I 7223 7224 7225 7226 7227 7228 A A I I I I II II II II II II 10/19/1987 11/9/1987 10/28/1987 11/19/1987 11/20/1987 11/30/1987 I I II II I 9/18/1987 10/13/1987 11/13/1987 I I I A I I I I II II I II II II II I II 11/4/1987 10/26/1987 11/4/1987 10/29/1987 10/28/1987 10/28/1987 11/6/1987 11/10/1987 11/10/1987 AMERICAN TOYKO KASEI INC BLASCHIM SPA TCI AMERICA BASF PHARMA EVIONNAZ SA ARCHIMICA SPA ARCHIMICA SPA SOUTHERN RESEARCH INSTITUTE PACO LABORATORIES INC ORION CORPORATION FERMION OULU PLANT ASHOK ORGANIC INDUSTRIES LTD SIGMA F AND D DIV LTD CAPSULE TECHNOLOGY INTERNATIONAL LTD SEKISUI MEDICAL CO LTD PHARMACIA AND UPJOHN QUATRUM EMS DOTTIKON AG ICN RADIOCHEMICALS QUATRUM I I I I III II I III I 9/30/1987 11/2/1987 10/26/1987 10/27/1987 11/5/1987 ALUMINUM COMPANY OF AMERICA CHUGAI PHARMACEUTICAL CO LTD MEGAS MANUFACTURING INC TECH SEAL PRODUCTS INC BRANTFORD CHEMICALS INC I II I 11/2/1987 10/21/1987 I I I I II II II III II 7/1/1987 10/21/1987 10/23/1987 10/5/1987 10/22/1987 FINE CHEMICALS CORPORATION IMPERIAL CHEMICAL INDUSTRIES PLC UNILEVER UNITED STATES INC ALUMINUM COMPANY OF AMERICA ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV CHUGAI PHARMACEUTICAL CO LTD LEBERCO-CELSIS TESTING A II I 10/28/1987 10/22/1987 NV ORGANON A&I LABORATORY STATUS Type SUBMIT DATE I I I II I II I 10/26/1987 10/26/1987 10/16/1987 10/28/1987 HOLDER DELMAR CHEMS LTD ORGANON INC CADILA LABORATORIES PVT LTD HEUMANN SUBJECT CLINDAMYCIN PHOSPHATE AS MFG. IN QUEBEC, CANADA ORGANIZATION, FACILITIES AND PROCEDURES IN WEST ORANGE, N.J. TRIMETHOPRIM AS MFG. IN GUJARAT STATE, INDIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FEUCHT, GERMANY. DESOGESTREL AS MFG. IN OSS, HOLLAND

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ARLINGTON, TEXAS. MINOCYCLINE HYDROCHLORIDE MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA. ATENOLOL BULK DRUG MANUFACTURED IN GUAYAMA, PUERTO RICO. ENCAPSULATED CIMETIDINE DURKOTE 130M-50 AND DURKOTE 145-50 PACKAGING STRUCTURES PHAR 9424 & 9425 AS MFG. PITTSBURGH,PA PRAZOSIN HYDROCHLORIDE USP&PRAZOSIN HYDROCHLORIDE,POLYHYDRATE CCA (LOBENZARIT SODIUM) TABLETS AS MFG. IN TOKYO, JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ROSELLE PARK, NEW JERSEY. 28 MM & 38 MM PP DROP-LOCK CLOSURES AS MFG. IN PITTSBURGH,PA CCA (LOBENZARIT SODIUM) BULK DRUG AS MFG. IN SHIZUOKA, JAPAN FACILITIES, PERSONNEL & PRODUACTION CONTROLS IN CLEVELAND, OH LINER MATERIALS & TAMPER EVIDENCE INNERSEALS MFG ROSELLE, IL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ONTARIO, CANADA. TRANS-1,2-CYCLOHEXANEDIAMINETETRAACETIC ACID MFG. PORTLAND OR GEMFIBROZIL USP AS MFG. IN MILANO, ITALY FACILITIES, PERSONNEL & GENERAL PROCEDURES IN PORTLAND, OR OXYBUTININ CHLORIDE AS MFG. IN EVIONNAZ, SWITZERLAND DOXYLAMINE SUCCINATE USP AS MFG. IN VARESE, ITALY DESIPRAMINE HYDROCHLORIDE USP AS MFG. IN VARESE, ITALY [D-TRPS6, DES-GLY10] - LHRH ETHYLMIDE AS MFG. BIRMINGHAM, AL. FACILITIES AND GENERAL OPERATING PROCEDURES IN PENNSAUKEN, NJ SELENIUM SULFIDE AS MFG. IN OULU, FINLAND PARACETAMOL AS MFG. IN BOMBAY, INDIA ACETYLCHOLINE CHLORIDE AS MFG. IN SAINT LOUIS, MISSOURI FACILITIES, EQUIPMENT AND PROCEDURES IN WINDSOR, ONTARIO, CN. L-LEUCINE AS MFG. IN CHUO-KU, TOKYO, JAPAN ETHINYL ESTRADIOL AS MFG. IN CUERNAVACA, MORELOS, MEXICO DEXAMETHASONE SODIUM PHOSPHATE AS MFG. IN SACAVEM, PORTUGAL DILUTED PENTAERYTHRITOL TETRANITRATE AS MFG. IN DOTTIKON, SZ. SODIUM IODIDE-131 AS MFG. IN IRVINE, CALIFORNIA BETMETHASONE SODIUM PHOSPHATE AS MFG IN SACAVEM, PORTUGAL -

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4Q2012EXCEL DMF# 7229 7230 7231 7232 7233 7234 7235 A 7236 7237 7238 7239 7240 7241 7242 7243 I 7244 7245 7246 A 7247 7248 7249 7250 7251 7252 7253 I 7254 7255 7256 7257 7258 I 7259 7260 I 7261 7262 I 7263 A II 12/23/1987 I III II 10/15/1987 12/16/1987 ANDERSON TOOL & DIE CORP I I IV 12/21/1987 12/7/1987 JOHNSON MATTHEY PLC NATIONAL STARCH LLC I I I I I II III III I 12/11/1987 12/14/1987 12/16/1987 12/2/1987 12/8/1987 WADDINGTON JAYCARE LTD QUATRUM PRO GRAM PLASTICS INC COURTESY PLASTICS ACCRA PAC INC A I I I I I II II II I IV II I 12/9/1987 12/7/1987 12/11/1987 12/10/1987 12/7/1987 12/9/1987 12/9/1988 I I II II II 11/7/1987 12/3/1987 12/7/1987 ALFA CHEMICALS ITALIANA SPA DELMAR CHEMICALS INC CORN PRODUCTS BRASIL INGREDIENTS INDUSTRIAIS LTDA YUNG ZIP CHEMICAL IND CO LTD DEGUSSA AG APOTEX PHARMACHEM INC BORREGAARD INDUSTRIES LTD UNGERER AND CO DAINIPPON PHARMACEUTICAL CO LTD NATIONAL O RINGS VERAPAMIL HYDROCHLORIDE AS MFG. IN PONTECCHIO MARCONI, ITALY NIFEDIPINE AS MFG. IN LASALLE, QUEBEC, CANADA MANNITOL AS MFG. IN SAO GONCALO-RJ, BRAZIL. SODIUM STARCH GLYCOLATE AS MFG. IN TAICHUNG HSIEN, TAIWAN CHLORHEXIDINE ACETATE AS MFG. IN HANAU, GERMANY GAMMA-HYDROXYBUTYRATE AS MFG. IN ONTARIO, CANADA FACILITIES, PERSONNEL & PROCEDURES IN SARPSBORG, NORWAY ARTIFICIAL GRAPE FLAVOR #18176 AS MFG. IN LINCOLN PARK, NJ ENOXACIN SESQUIHYDRATE AS MFG. IN SUZUKA, MIE, JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DOWNEY, CALIFORNIA PRODUCTION OF JAYCAPS IN LONDON, ENGLAND TRIAMCINOLONE HEXACETONIDE AS MFG. IN SACAVEM, PORTUGAL POLYETHYLENE AND POLYPROPYLENE CONTAINERS AS MFG. IN OHIO INJECTION MOLDED PARTS AS MFG. IN WHEELING, ILLINOIS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ELKHART, INDIANA. FACILITIES, EQUIPMENT & PROCEDURES IN BUCKHAVEN,FIFE,SCOTLAND I A I C I I I I II II II II II II II 11/16/1987 11/20/1987 11/19/1987 11/30/1987 10/26/1987 11/27/1987 11/9/1987 12/4/1987 STATUS Type SUBMIT DATE I I I I I I II III II I I II III 11/20/1987 11/25/1987 11/25/1987 11/16/1987 11/16/1987 11/17/1987 11/13/1987 HOLDER WARNER LAMBERT CO DIV PARKE DAVIS REXAM MEDICAL PACKAGING INC ELAN CORP PLC BEECHAM PHARMACEUTICALS BEECHAM PHARMACEUTICALS EURAND AMERICA INC EQUISTAR CHEMICALS LP SUB LYONDELLBASELL LISAC SA MALLINCKRODT INC SIPSY TEVA PHARMACEUTICAL INDUSTRIES LTD TORCAN CHEMICAL LTD ISOCHEM SA PROQUINA SA SUBJECT PHENYTOIN USP & PHENYTOIN SODIUM USP AS MFG. IN HOLLAND, MI MFG. OF FLEXIBLE P.V.C. PARENTERAL BAGS SPECIFIC DRUG SUBSTANCE PN-200-110 TABLETS AS MFG IN IRELAND FACIL, PERSONNEL & GENL OPER PROCED IN GREA BURGH, EPSOM, U.K.

4Q2012

FACIL, PERSONNEL AND GENERAL OPERATING PROCEDURES IN HARLOW, ESSEX. CIMETIDINE BASE MICROCAPSULES AS MFG. IN VANDALIA, OHIO. ALATHON POLYETHYLENE RESIN COMPOUNDS MANUFACTURED IN TEXAS. FACIL, PERSONNEL, EQUIP & PROCEDURES IN BARCELONA, SPAIN HYDROMORPHONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ST. LOUIS, MO TRIMEBUTINE BASE & TRIMEBUTINE MALEATE AS MFG IN FRANCE DILTIAZEM HCL MFG IN NATAWANYA,ISREAL DILTIAZEM HYDROCHLORIDE AS MFG IN LASALLE, QUEBEC, CANADA 3-(PHOSPHORYLOXMETHYL)-5,5-DIPHENYL HYDANTOIN DISODIUM SALT SALAZOSULFAPYRIDINE AS MFG IN IXTACZOQUITLAN, VER., MEXICO

ALLERGAN OPTICAL INC DIV ALLERGAN INC MIOGAN (ACETYLCHOLINE CHLORIDE FOR OPTHALMIC SOLUTION)

MODIFIED FOOD STARCHES FOR USE AS PHARMACEUTICAL EXCIPIENTS AS MFG. IN BRIDGEWATER, NEW JERSEY DRY SCRUB BRUSH AS MFG. IN LINDEN, NEW JERSEY

WISCONSIN ANALYTICAL & RESEARCH CLORAZEPATE AS MFG. IN MADISON, WISCONSIN SERVICES LTD VERTELLUS PERFORMANCE MATERIALS INC TRIBUTYL CITRATE AS MFG. IN GREENSBORO, NORTH CAROLINA

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4Q2012EXCEL DMF# 7264 7265 I 7266 7267 7268 7269 I 7270 7271 7272 A 7273 A 7274 7275 7276 7277 I 7278 7279 7280 I 7281 7282 A 7283 7284 7285 7286 I 7287 7288 7289 7290 7291 7292 7293 7294 7295 7296 7297 7298 I I I I A I I I I I I I II II II I II II II I II II II II 1/6/1988 1/5/1988 1/5/1988 1/6/1988 1/8/1988 1/15/1988 12/1/1987 1/19/1988 2/2/1988 12/29/1987 1/22/1988 11/1/1987 BLASCHIM SPA AMERICAN CHEMICAL INDUSTRIAL CORP AMERICAN CHEMICAL INDUSTRIAL CORP MINNTECH CORP NORAMCO INC LEJUS PHARMACEUTICAL PRODUCT SIGMA F AND D DIV LTD IMAGENTS INC PFANSTIEHL LABORATORIES INC RALLIS INDIA LTD CUNO INC FINE CHEMICALS CORPORATION I I I II II II I 1/8/1988 1/14/1988 1/14/1988 12/18/1987 I II II 1/5/1988 1/13/1988 CHEMWERTH NANJING PHARMACEUTICAL FACTORY CO LTD PHARM ECO LABORATORIES INC LION CORPORATION LION CORPORATION MERCK SHARP & DOHME CAGUAS I I II II II 1/1/1988 10/20/1987 1/4/1988 SIGMA F AND D DIV LTD NIPPON RIKAGAKUYAKUHIN CO LTD GUANGDONG PHARMACEUTICAL FACTORY L-TRYPTOPHAN ETHYL ESTER HCL AS MFG. IN SAINT LOUIS, MISSOURI L-2-OXOTHIAZOLIZINE-4-CARBOXYLIC ACID AS MFG. IN TOKYO, JAPAN SULFAMETHAZINE MANUFACTURED IN GUANGZHOU, CHINA. I I I II II II II 12/21/1987 1/4/1988 10/20/1987 1/4/1988 III 1/7/1988 I I II III II 12/18/1987 12/28/1987 12/31/1987 I I I III II II II 12/7/1987 12/29/1987 12/12/1987 12/10/1987 STATUS Type SUBMIT DATE C II II 12/22/1987 12/23/1987 HOLDER TEVA PHARMACEUTICAL INDUSTRIES LTD AMSA ANONIMA MEDICINALI SINTETICI & AFFINI SPA ZIMMER PAPER PRODUCTS INC DIOSYNTH BV YUKI GOSEI KOGYO CO LTD COMPANIA ESPANOLA DE SINTESIS QUIMICA SA ALFA CHEMICAL ITALIANA BF ASCHER AND CO INC SUBJECT TIMOLOL MALEATE AS MFG. IN SETTIMO ATENOLOL AS MFG. IN COMO, ITALY INNERSEALS MANUFACTURED IN INDIANAPOLIS, INDIANA. 2-PHENYL-1,3-PROPANEDIOL DICARBAMATE AS MFG. IN OSS, HOLLAND 2' DEOXYCYTIDINE HYDROCHLORIDE (BULK) AS MFG. IN TOKYO,JAPAN BETAMETHASONE ACETATE AS MFG. IN MADRID, SPAIN TOLMETIN SODIUM DIHYDRATE AS MFG. IN BOLOGNA, ITALY PACKAGING MATERIALS AS MFG. IN LENEXA, KANSAS

4Q2012

UNION QUIMICO FARMACEUTICA SA UQUIFA CYCLOPENTOLATE HYDROCHLORIDE AS MFG. IN BARCELONA, SPAIN SA CONSTANTIA HUECK FOLIEN GMBH AND CO DECORATED AND/OR LAMINATED FLEX. MATERIALS AS MFG.IN GERMANY KG PLAISTOW LTD FENOFIBRATE AS MFG. IN LITTLE ISLAND, CORK, IRELAND SELOC FRANCE NIPPON RIKAGAKUYAKUHIN CO LTD GUANGDONG PHARMACEUTICAL FACTORY XYLAZINE HYDROCHLORIDE AS MFG. BY SIFA LTD. IN IRELAND CARBOCYSTEINE (S-CARBOXYMETHYL-L-CYSTEINE) AS MFG. IN TOKYO TRIMETHOPRIM AND SULFAMETHOXAZOLE AS MFG, IN GUANGZHOU, CHINA

DOXYCYCLINE MONOHYDRATE MANUFACTURED BY CHANGZHOU PHARMACEUTICAL. SUCRALFATE MANUFACTURED IN NANJING, CHINA. N,N-BIS-(PYRIDOXAL-5-PHOSPHATE)ETHYLENEDIAMINE-N,N-DIACETIC ACID GLYCERIDE OF PENTADECANOIC ACID (PDG) DRUG SUBSTANCE LKF DRUG PRODUCT AS MFG, IN KASHIMA-GUN, JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CAGUAS, PUERTO RICO. TRAZODONE HYDROCHLORIDE MANUFACTURED IN MILAN, ITALY. CARBAMAZEPINE MANUFACTURED IN RICHMOND, CALIFORNIA. CLINDAMYCIN HYDROCHLORIDE AS MFG. IN RICHMOND, CALIFORNIA WATER FILTER AS MFG, IN MINNEAPOLIS, MINNESOTA CHLORZOXAZONE AS MFG. IN ATHENS, GEORGIA QUINIDINE GLUCONATE EXTENDED RELEASE GRANULES AS MFG. IN SWEDEN (+) - AMETHOPTERIN (METHOTREXATE) AS MFG. IN SAINT LOUIS, MISSOURI FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN HOUSTON, TX D-GALACTOSE AS MFG. IN WAUKEGAN, IL. IBUPROFEN U.S.P. AS MFG, IN GUJARA, INDIA ZETAPREP SP MEDIA AS MFG. IN CONNECTICUT TOLAZOLINE HYDROCHLORIDE AS MFG. IN CAPE PROVINCE, S. AFRICA

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4Q2012EXCEL DMF# 7299 I 7300 7301 7302 7303 I 7304 7305 7306 7307 7308 7309 7310 7311 7312 7313 7314 7315 7316 7317 I 7318 7319 7320 7321 7322 7323 7324 7325 7326 7327 7328 7329 7330 I 7331 7332 7333 7334 7335 7336 I I A I I I II II II II I II 1/20/1988 2/16/1988 2/8/1988 2/9/1988 2/18/1988 2/5/1988 NIPPON KAYAKU COMPANY LTD GEDEON RICHTER BASF PHARMA EVIONNAZ SA BOEHRINGER INGELHEIM PHARMA KG GLAXO WELLCOME INC COSMA SPA I I I I I I A I I I I A I I I I II II II III III II II II I 1/15/1988 1/28/1987 2/5/1988 2/10/1988 2/9/1988 2/10/1988 2/5/1988 1/25/1988 2/16/1988 2/16/1988 2/9/1988 2/12/1988 2/8/1988 I I A I I I I A I I I I I II I II II I I II II I II II I II II 1/22/1988 1/26/1988 1/27/1988 1/29/1988 12/17/1987 2/1/1988 2/2/1988 2/2/1988 1/27/1988 2/1/1988 2/2/1988 2/1/1988 2/2/1988 2/4/1988 EASTMAN KODAK CO MITCHELL COTTS CHEMICALS LTD MOEHS IBERICA SL BASF CORP SIPHARM SUB OF SELOC AG FORMULATION DEVELOPMENT CO HOECHST MARION ROUSSEL SA EXCELLA GMBH SWISS CAPS CHEMISCHE FABRIK WEYL GMBH REXIM SA DIV DEGUSSA STERIS LABORATORIES INC REXIM SA DIV DEGUSSA AG WISCONSIN ANALYTICAL & RESEARCH SERVICES LTD BRADY ENTERPRISES INC THERMO PAK COMPANY LTD 3M PHARMS SOLOPAK LABORATORIES RESEARCH BIOCHMICALS INC DIOSYNTH BV PUROLITE CO HUNTSMAN CHEMICAL CORP 4P VERPACKUNGEN RONSBERG GMBH IMAGENTS INC ORGANICS DIV LA GRANGE INC BASF PHARMA EVIONNAZ SA HOECHST CELANESE CORP I I I II II II V 1/22/1988 1/6/1988 1/2/1988 12/30/1987 CUNO INC BOEHRINGER INGELHEIM KG CUNO INC MOVA PHARMACEUTICAL CORP STATUS Type SUBMIT DATE II 1/25/1988 HOLDER SIFAVITOR SPA SUBJECT

4Q2012

LOPERAMIDE HYDROCHLORIDE AS MFG. A CASALETTO LODIGIANO (FRAZ. MAIRANO) MILAN, ITALY BY SIFAVITOR S.P.A. ZETAPREP DEAE MEDIA AS MFG. IN CONNECTICUT THEOPHYLLINE MONOHYDRATE AS MFG. IN INGELHEIM, GERMANY ZETAPREP QEA MEDIA AS MFG. IN CONNECTICUT STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN CAGUAS, PUERTO RICO 3-(PHOSPHORYLOXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM SALT FACILITY AT MIRFIELD, UK METOPROLOL TARTRATE AS MFG. IN BARCELONA, SPAIN BIS-2-ETHYLHEXYL PHTHALATE AS MFG. IN KEARNY, NEW JERSEY FACILITIES, PERSONNEL AND PROCEDURES IN SISSELN, SWITZERLAND FACILITIES, PERSONNEL AND PROCEDURES IN WILMINGTON, N.CAROLINA BETAMETHASONE VALERATE USP, BP AS MFG. IN VERTOLAYE, FRANCE BACLOFEN (ESUB) AS MANUFACTURED IN NUREMBERG,GERMANY FACILITIES, PERSONNEL AND PROCEDURES IN KIRCHBERG, SWITZERLAND ACETYLSALICYLIC ACID AS MFG. IN MANNHEIM, GERMANY L-AMINO ACIDS AS MFG. IN HAM FRANCE FACILITIES & STANDARD OPERATING PROCEDURES IN ARIZONA N-ACETYL L-TYROSINE AS MFG. IN HAM, FRANCE DETERMINATION OF OXAZEPAM IN HUMAN PLASMA MANUFACTURING FACILITIES AND PROCEDURES IN E. WEYMOUTH, MA. FACILITIES AND PROCEDURES IN WOOD DALE, ILLINOIS FACILITIES, PERSONNEL AND PROCED. IN PITHIVIERS, CEDEX, FRANCE FACILITIES, PERSONNEL AND PROCEDURES IN ELK GROVE VILLAGE, IL. SKF-38393 HCL AS ENCAPSULATED A NORTHEASTERN UNIV.,BOSTON,MA 5',8-DIMETHOXYLAUDANOSINE HCL AS MFG. IN OSS, HOLLAND CHOLESTYRAMINE RESIN USP AS MFG. IN VICTORIA, RUMANIA POLYPROPYLENE MANUFACTURED IN WOODBURY, NEW JERSEY. FLEXIBLE FOIL LAMINATE AS MFG. IN RONSBERG, GERMANY RADIOCHEMICAL INDIUM CHLORIDE IN-111 AS MFG. IN HOUSTON, TEX. CONJUGATED ESTROGENS FOR INJECTION USP POWDER - CHICAGO, IL. CHOLINE-SALICYLATE 80% AS MFG. IN EVIONNAZ, SWITZERLAND MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BISHOP, TEXAS. BUTADIAMUPLATIN AS MFG. IN TOKYO, JAPAN NORETHINDRONE 0.5 MG. AND ETHINYL ESTRADIOL 0.035 METHENAMINE HIPPURATE AS MFG. IN EVIONNAZ, SWITZERLAND AROPINE METHYLNITRATE AS MFG, IN INGELHEIM, GERMANY FACILITY LOCATED IN EDINBURG, SCOTLAND TOLMETIN SODIUM AS MFG. IN CISERANO (BG) ITALY

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4Q2012EXCEL DMF# 7337 I 7338 7339 I 7340 7341 7342 I 7343 7344 7345 7346 7347 7348 7349 7350 7351 A 7352 I 7353 7354 7355 7356 7357 7358 7359 7360 I 7361 7362 I 7363 7364 7365 7366 7367 7368 7369 7370 7371 7372 I I I A I I I I I I I II II II IV II IV II II I 3/3/1988 3/4/1988 2/28/1988 3/4/1988 3/7/1988 3/8/1988 3/7/1988 3/1/1988 3/1/1988 2/26/1988 I II III 2/29/1988 3/3/1988 I I I A I I I II II III II II I II II 2/10/1988 2/17/1988 2/29/1988 2/29/1988 3/2/1988 2/23/1988 2/29/1988 2/25/1988 CHEMISCHE FABRIK WEYL GMBH ROHM PHARMA GMBH SPECIALTY PACKAGING PRODUCTS INC ASTELLAS IRELAND CO LTD TRANSPHARMA LTD SILGAN PLASTICS CORPORATION AMERICAN CHEMICAL INDUSTRIAL CORP RP SCHERER NORTH AMERICA DIV RP SCHERER CORP AMERICAN CHEMICAL INDUSTRIAL CORP I 2/23/1988 FORTUNE PLASTICS I I I I I I I I II II I II II II I II IV 2/18/1988 2/10/1988 2/12/1988 2/16/1988 2/17/1988 2/25/1988 2/18/1988 2/25/1988 2/18/1988 MACFARLAN SMITH FABBRICA ITALIANI SINTETICI SPA SCHERING AG NITSON LABORATORIES JAPAN CHEMICAL RESEARCH CO LTD CADILA LABORATORIES PVT LTD LIPOID KG CADILA LABORATORIES PVT LTD LIPOID GMBH BUPRENORPHINE HYDROCHLORIDE MFG. IN EDINBURG, SCOTLAND TRIAMTERENE MFG. IN VICENZA - ITALY MFG. AND CONTROL OF CLINICAL SUPPLIES IN BERLIN,GERMANY SULPHAMETHOXAZOLE USP AS MFG. IN THANE AND VAPI, INDIA UROKINASE (BULK) AS MFG. IN KOBE, JAPAN PHENYTOIN USP & PHENYTOIN SODIUM USP MFG. IN GUJARA, INDIA FACILITIES, AND PERSONNEL LOCATED IN LUDWIGSHAFEN GERMANY SULFAMETHOXAZOLE USP MFG. IN GUJARA, INDIA A I II II II 2/17/1988 2/25/1988 2/17/1988 TEVA PHARMACEUTICAL INDUSTRIES LTD ORION CORP FARMOS CHEMICAL PLANT LOPERAMIDE HYDROCHLORIDE AS MFG. IN MILAN, ITALY CYCLOPHOSPHAMIDE 50 MG. TABL. AS MFG, IN TURKU, FINLAND I II I 2/19/1988 2/17/1988 STATUS Type SUBMIT DATE II 2/19/1988 HOLDER NANTONG GENERAL PHARMACEUTICAL FACTORY HEXACHIMIE SUBJECT 5-FLUOROURACIL AS MFG, IN NANTONG, JIANGSU PROVINCE, CHINA CIBENZOLINE SUCCINATE INN. OR CIFENLINE SUCCINATE USAN

4Q2012

GREAT LAKES CHEMICAL KONSTANZ GMBH L-AMINO ACID AS MFG. IN KONSTANZ, GERMANY

GREAT LAKES CHEMICAL KONSTANZ GMBH L-METHIONINE AS MFG. IN KONSTANZ, GERMANY

LIPOID E 80 AND LIPOID E 80 S AS MANUFACTURED IN LUDWIGSHAFEN OR COLOGNE, GERMANY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RICHMOND, VIRGINIA. 5.7-DICHLORO-8-HYDROXYQUINOLINE MFG. IN MANNHEIM, GERMANY THEOPHYLLINE R 85 D/02 MFG. IN WEITERSTADT, W. GERMANY DESCRIPTION OF LOTION PUMP SYSTEM LOCATED IN BRIDGEPORT, CT FAMOTIDINE MFG. IN DUBLIN, IRELAND ENCAPSULATED POTASSIUM CHLORIDE MFG. IN VANDALIA, OH FACILITIES LOCATED IN FRANKLIN, KY CLINDAMYCIN PHOSPHATE MFG. IN RICHMOND, CA ALBUTEROL 8 MG, LOT E-14274 MFG. IN CLEARWATER, FL CARBIDOPA MFG. IN RICHMOND, CA

FIRESTONE SYNTHETIC RUBBER AND LATEX STEREON 840 AND 881 AS MFG. IN AKRON, OH. CO SILGAN PLASTICS CORPORATION FACILITIES LOCATED IN LOUISVILLE, KY. APOTEX PHARMACHEM INC NYCOMED AUSTRIA GMBH NV ORGANON AVANTI POLAR LIPIDS INC RESOLUTION CHEMICALS LTD AVANTI POLAR LIPIDS INC SIGMA F AND D DIV LTD HOECHST AG SANOFI PHARMACEUTICALS INC CYTARABINE USP XXI MFG. IN BRANTFORD & MISSISSAUGA, CANADA SUXAMETHONIUM CHLORIDE AS MFG. IN LINZ, AUSTRIA ETHYNODIOL DIACETATE AS MFG. IN OSS, THE NETHERLANDS 1,2-DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOCHOLINE MFG. PELHAM, AL. BACLOFEN AS MFG. BY MITCHELL COTTS-CHEMICALS 1,2-DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL MFG. PELHAM, AL DL-3,4- DIHYDROXYPHENYLGLYCOL #D9753FD MFG. IN ST LOUIS, MO EBIRAIDE (HOE 427) BULK DRUG AS MFG. IN FRANFURT, GERMANY CONTRACT PACKAGING OPERATIONS ONLY, LOCATED IN FENTON, MO

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4Q2012EXCEL DMF# 7373 7374 7375 7376 7377 7378 7379 7380 A 7381 7382 7383 7384 7385 7386 7387 7388 I 7389 7390 7391 7392 7393 7394 7395 7396 7397 7398 7399 7400 7401 7402 7403 7404 7405 7406 7407 7408 7409 7410 7411 I I I I I I I I A I I I I I I I I I A A A A I II I II I II IV III I IV II I I II II II III II I III II II II II 2/2/1988 3/15/1988 3/22/1988 3/22/1988 3/11/1988 3/16/1988 3/23/1988 3/29/1988 3/25/1988 3/3/1988 3/24/1988 2/29/1988 3/22/1988 2/29/1988 3/21/1988 3/29/1988 3/26/1988 3/30/1988 3/22/1988 3/30/1988 3/28/1988 3/30/1988 3/30/1988 I I I I I I I III III II II I II II II 2/4/1988 3/10/1988 3/8/1988 2/19/1988 3/12/1988 3/18/1988 3/21/1988 3/18/1988 STATUS Type SUBMIT DATE A I I A A I I III II II II III II II II 2/25/1988 3/7/1988 3/4/1988 3/4/1988 3/17/1988 3/7/1988 3/3/1988 3/11/1988 HOLDER MITSUBISHI POLYSTER FILM GMBH AZEO PROCESSING INC SCHERING AG FDC LTD MULTISORB TECHNOLOGIES INC PENINSULA LABS ALDRICH CHEMICAL COMPANY INC NIPPON SYNTHETIC CHEMICAL INDUSTRY CO LTD COMAR INC MALLINCKRODT INC CREATIVE BIOMOLECULES CESQUISA SA HAUSER CHEMICAL RESEARCH INC QUATRUM DAN DONG PHARMACEUTICALS WISCONSIN ANALYTICAL & RESEARCH SERVICES LTD HOECHST MARION ROUSSEL SA PHILLIPS MANUFACTURING CO FARMABOIS VESTAR RESEARCH INC SIGMA F AND D DIV LTD AC MOLDING COMPOUNDS BLISPAK INC CAPSUGEL ISOCHEM SA HICKSON PHARMACHEM LTD WOCKHARDT LTD FABBRICA ITALIANI SINTETICI SPA WOCKHARDT LTD SIGMA F AND D DIV LTD FILTER PRODUCTS INC MEDEA RESEARCH LABS PHYTEX AUSTRALIA PTY LTD PRESSPART MANUFACTURING LTD PHYTEX AUSTRALIA PARTY LTD CAMBREX PROFARMACO MILANO SRL PHYTEX AUSTRALIA PARTY LTD EGIS PHARMACEUTICALS SUBJECT PACKAGING MATERIAL AS MFG. IN WIESBADEN, GERMANY THYROGLOBULIN, USP MFG. IN WAUTOMA, WI ZK 112 119(6-BOCIP) AS MFG. IN BERLIN OR BERGKAMEN GERMANY MICONAZOLE NITRATE AS MFG. IN ROHA, INDIA ACTIVATED, BAGGED DESICCANT AS MFG. IN BUFFALO, NY CORTICOTROPIN RELEASING FACTORAS MFG. IN BELMONT, CA. POLYBRENE, PRODUCT# 10,768-9 AS MFG. IN MILWAUKEE, WI VALPROIC ACID AS MFG. IN OGAKI AND MIZUSHIMA, JAPAN PACKAGING MATERIALS (SEALS) AS MFG. IN BUENA, NJ DAA ON 890 GREY (28 MM STOPPER) AS MFG. BY WEST CO. EPIDERMAL GROWTH FACTOR, HEGF AS MFG. IN HOPKINTON, MA FLUOCINONIDE AS MFG. IN SEGOVIA, SPAIN FACILITIES AND PERSONNEL IN BOULDER COLORADO FLUOCINOLONE ACETONIDE AS MFG. IN SACAVEM, PORTUGAL THEOPHYLLINE AS MFG. IN LIAONING, CHINA CI-925 AND CI-929 AS DETERMINDE IN HUMAN PLASMA BETAMETHASONE DIPROPIONATE AS MFG. IN VERTOLAYE, FRANCE MANUFACTURING SITE AND FACILITIES LOCATED IN CANTON, MA FLUOCINONIDE MFG. IN PAVIA, ITALY

4Q2012

MANUFACTURING SITE, FACILITIES, AND CONTROLS LOCATED IN PASADENA, CA D (-)-RIBOSE PRODUCT # R 7500 FD MFG. IN ST. LOUIS, MO. UREA RESINS MANUFACTURED IN DALLAS, TEXAS. CONTRACT PACKAGING FACILITY LOCATED IN FAIRFIELD, NEW JERSEY GELATIN CAPSULES MANUFACTURED IN SAGAMIHARA, JAPAN QUINIDINE BISULPHATE AS MFG. IN GENNEVILLIERS, FRANCE FACILITIES AND PERSONNEL IN RINGASKIDDY, COUNTY CORK, IRELAND FACILITIES A ANKLESHWAR, INDIA DESIPRAMINE HYDROCHLORIDE AS MFG. IN VICENZA, ITALY D-OXYPHEN BASE AS MFG. IN ANKLESHWAR, INDIA OLEIC ACID SODIUM 95% AS MFG. IN ST. LOUIS, MISSOURI PHARMACEUTICAL-GRADE FILTER MEDIA AS MFG. IN SACRAMENTO, CA. PHOSPHOCYSTEAMINE AS MFG. IN WESTHAMPTON BEACH, NEW YORK SITE, FACILITIES AND PERSONNEL LOCATED IN PERKHURST, AUSTRALIA PKG. MATERIAL FOR PHARM. AEROSOL AS MFG. IN LANCASHIRE, UK SCOPOLAMINE BASE AS MFG. IN PERKHURST, AUSTRALIA AMILORIDE HCL AS MFG. IN MILAN, ITALY METHSCOPOLAMINE BROMIDE MANUFACTURED IN PERKHURST, AUSTRALIA. ETHACRYNIC ACID MANUFACTURED IN BUDAPEST AND DORMEND, HUNGARY.

HENRY H OTTENS MANUFACTURING CO INC EXCIPIENTS, COLORANTS, FLAVORS, ESSENCES AS MFG. IN PHILA. PA

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4Q2012EXCEL DMF# 7412 7413 7414 7415 7416 7417 7418 7419 7420 7421 7422 7423 7424 7425 A 7426 7427 7428 7429 7430 7431 I 7432 7433 7434 I 7435 7436 7437 7438 7439 7440 7441 7442 7443 7444 7445 7446 7447 7448 7449 7450 I I A I I I I I I I A I I I I I IV II IV I III I III I I II II II II II I I 4/14/1988 3/30/1988 4/15/1988 4/14/1988 4/14/1988 4/12/1988 4/20/1988 4/22/1988 4/18/1988 4/22/1988 4/22/1988 4/18/1988 3/15/1988 4/15/1988 4/22/1988 4/22/1988 PHARMATEC INC NATL INST HLTH ADAMHA DOC GRAIN PROCESSING CORP SEPPIC DIV AIR LIQUIDE FORTUNE PLASTICS BIRMINGHAM POLYMERS INC HELVOET PHARMA MARYLAND SILARX PHARMACEUTICALS INC HEALTH CARE INC WYCKOFF CHEMICAL CO INC TEVA PHARMACEUTICAL INDUSTRIES LTD SIGMA F AND D DIV LTD WOCKHARDT LTD SOCIETA ITALIANA CORTICOSTEROIDI SPA BIOCHEMIC GESELLSCHAFT MBH REPLIGEN CORPORATION I I II II III 4/18/1988 4/11/1988 4/15/1988 QUATRUM WASHINGTON BIOLAB INC HELVOET PHARMA MARYLAND A I I I I II II II III II III 4/11/1988 4/12/1988 4/18/1988 4/15/1988 4/12/1988 4/15/1988 SIGNA SA DE CV PHARM ECO LABORATORIES INC SERONO INC HELVOET PHARMA MARYLAND DINAMITE DIPHARMA SPA HELVOET PHARMA MARYLAND NADOLOL AS MFG. IN ONTARIO, CANADA TRICAINE AS MFG. IN SIMI VALLEY, CALIFORNIA LH ENRICHED FRACTION AS MFG. IN (ROMA) ITALY RUBBER CLOSURE FORMULATION B5002-45 - SALISBURY, MD. GEMFIBROZIL AS MFG. IN MILAN, ITALY STATUS Type SUBMIT DATE I I A A I A I I I I I I I V II II II II II I II IV I II II II II 4/5/1988 3/31/1988 3/30/1988 3/30/1988 4/4/1988 3/30/1988 4/6/1988 4/6/1988 3/18/1988 4/6/1988 4/7/1988 4/12/1988 4/5/1988 4/11/1988 HOLDER LUITPOLD PHARMACEUTICALS INC JACOBUS PHARMACEUTICAL CO SIGMA ALDRICH IRELAND LTD PHYTEX AUSTRALIA PARTY LTD ROUSSEL-UCLAF PHYTEX AUSTRALIA PARTY LTD EXPANSIA BIOCHEMIC GESELLSCHAFT MBH GUJARAT THEMIS BIOSYN LTD BIOCHEMIC GESELLSCHAFT MBH ISOCHEM SA IMAGENTS INC SOCIETA ITALIANA CORTICOSTEROIDI SPA SUBJECT STERILE PROCESSING FACILITY LOCATED IN SHIRLEY, NEW YORK DAPSONE (FINAL DOSAGE FORMS) AS MFG. IN PLAINSBORO, N.J. NORTRIPTYLINE HYDROCHLORIDE AS MFG. IN ARKLOW, IRELAND

4Q2012

SCOPOLAMINE HYDROBROMIDE MANUFACTURED IN PERKHURST, AUSTRALIA. HYDROCORTISONE SODIUM PHOSPHATE AS MFG. IN VERTOLAYE, FRANCE HYOSCINE METHONITRATE AS MFG. IN PERKHURST, AUSTRALIA MANUFACTURING FACILITIES LOCATED IN ISLE-SUR-SORGUE, FRANCE THIOPENTAL SODIUM AS MFG. IN KUFSTIEN-SCHAFTENAU, AUSTRIA ERYTHROMYCIN THIOCYANATE AS MFG. IN VAPI, GUJARAT STATE,INDIA PENICILLIN RECOVERY PLANT IN KUNDL, TYROL, AUSTRIAL DILTIAZEM HCL AS MFG. IN GENNEVILLIERS, FRANCE RADIOCHEMICAL STRONTIUM CHLORIDE SR-82 AS MFG. IN HOUSTON, TX DESOXIMETASONE AS MFG. IN MILAN, ITALY

VERTELLUS PERFORMANCE MATERIALS INC ACETYLTRI-N-BUTYL CITRATE AS MFG. IN GREENSBORO, N. CAROLINA

RUBBER CLOSURE FORMULATION B5002-50 GRAY MANUFACTURED IN SALISBURY, MARYLAND. FLUOCINONIDE AS MFG. IN LISBON, PORTUGAL HUMAN CHORIONIC GONADOTROPIN AS MFG. IN AMES, IOWA IPC RUBBER CLOSURE FORMULATION B5002-60 GRAY MANUFACTURED IN SALISBURY, MARYLAND. 2-HYDROXYPROPYL-B-CYCLODEXTRIN AS MFG. IN ALACHUA, FLORIDA INFORMATION ON FISH OILS AS SUBMITTED ON BEHALF OF FOTMAC MALTRIN MALTODEXTRIN AND MALTRIN CORN SYRUP SOLIDS LACAZE-BASSE FACTORY LOCATED IN CASTRES, FRANCE BLOW MOLDING OF PVC, LDPE, MDPE, HDPE PLASTICS BOTTLES FAC. PERSONNEL, AND GEN. OPERATING PROCEDURES AS MFG.IN AL. RUBBER CLOSURE FORMULATION LZ514 MANUFACTURED IN SALISBURY, MARYLAND. MFG. AND PROCESSING FAC. LOC'N IN SPRING VALLEY, N.Y. FACILITIES LOCATED IN ELKHART, INDIANA AMOXAPINE MANUFACTURED IN SOUTH HAVEN, MICHIGAN. GEMFIBROZIL MANUFACTURED IN NETANYA, ISRAEL. NICOTINE #3876 FD MANUFACTURED IN ST. LOUIS, MISSOURI. PIROXICAM AS MFG. IN ANKLESHWAR, INDIA HALCINONIDE AS MFG. IN MILAN, ITALY MULTIPURPOSE SYNTHESIS PLANT LOCATED IN KUNDL, TYROL, AUSTRIA FACILITIES LOCATED IN CAMBRIDGE, MA

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4Q2012EXCEL DMF# 7451 7452 7453 7454 I 7455 7456 7457 7458 7459 7460 7461 7462 7463 7464 7465 7466 7467 7468 7469 I 7470 7471 7472 7473 7474 7475 7476 7477 7478 7479 7480 7481 7482 7483 7484 7485 7486 7487 7488 7489 I I A I A I A A A I I I I I I A I I I I II IV II II II I IV IV III IV II II II II II II II II II II 5/13/1988 5/9/1988 5/11/1988 5/13/1988 5/11/1988 5/11/1988 5/10/1988 5/5/1988 5/12/1988 5/2/1988 5/16/1988 5/18/1988 5/18/1988 5/18/1988 5/10/1988 5/16/1988 5/17/1988 5/20/1988 5/16/1988 5/20/1988 GD SEARLE PHARMACEUTICALS INC CARRUBBA INC DIPHARMA FRANCIS SRL MOEHS SA DIV OF SANOF FIDIA FARMACEUTICI SPA EGIS PHARMACEUTICALS JM HUBER CORP HENKEL CORP FLINT HILLS RESOURCES LP NORWOOD INDUSTRIES INC DEGUSSA GMBH GEDEON RICHTER SIGMA F AND D DIV LTD KV PHARMACEUTICAL CO AVENTIS BEHRING FIDIA FARMACEUTICI SPA HEUMANN REPLIGEN CORPORATION SIGMA F AND D DIV LTD REPLIGEN CORPORATION I I I I I I I I I I I I I I II II III II II III II II II II II II I II I 4/25/1988 4/21/1988 5/2/1988 4/23/1988 5/5/1988 4/18/1988 5/2/1988 5/5/1988 5/1/1988 5/5/1988 5/3/1988 5/11/1988 5/5/1988 5/12/1988 5/10/1988 CHEMISCHE FABRIK WEYL GMBH ZAMBON SPA WEST PHARMACEUTICAL SERVICES INC FARMABOIS TEVA PHARMACEUTICAL INC WITTEN MANUFACTURING CO SIGMA F AND D DIV LTD BASF CORPORATION SYLATEC GROUPE SYNTHELABO ORGAMOL SA MEDEA RESEARCH LABS GEDEON RICHTER JUSTE SAQF BACHEM FINE CHEMICALS INC KNOLL PHARMA CHEMICALS VERAPAMIL HYDROCHLORIDE AS MFG. IN MANNHEIM, GERMANY NAPROXEN SODIUM AS MFG. IN VICENZA, ITALY PURCOAT MANUFACTURED IN PHOENIXVILLE, PENNSYLVANIA. FLUOCINOLONE ACETONIDE MFG. IN PAVIA, ITALY TRAZODONE HYDROCHLORIDE AS MFG. BY PLANTEX IN NETANYA, ISRAEL POLYESTER COIL FIBRE AS MFG. IN GASTONIA, NORTH CAROLINA MESO-2,3-DIMERCAPTOSUCCINIC ACID AS MFG. IN SAINT LOUIS, MO. ACETAMINOPHEN AS MFG. IN BISHOP, TEXAS KETO ACID TABLETS CODE CSW20-4 AS MFG. IN FRANCE AMSACRINE AS MFG. IN EVIONNAZ SWITZERLAND EDROPHONIUM CHLORIDE AS MFG. IN WESTHAMPTON BEACH, NEW YORK NORETHINDRONE 0.75 MG. AND ETHINYL ESTRADIOL 0.035 MG. TABLET FACILITIES, PERSONNEL AND OPERATING PROCEDURES-MADRID, SPAIN ARIAL NARIURETIC PEPTIDE (1-28) HUMAN AS MFG.-TORRANCE, CA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CRAMLINGTON, ENGLAND. DISOPYRAMIDE PHOSPHATE AS MFG. IN AUGUSTA, GA. AND CAGUAS, PR PINEAPPLE FLAVOR FORMULA #23297 AS MFG. IN MILFORD, CT. PIROXICAM AS MFG. IN MILAN, ITALY PIROXICAM AS MFG. IN BARCELONA, SPAIN TRETINOIN AS MFG. IN MILAN, ITALY LACTA FACTORY LOCATED IN KORMEND, HUNGARY CALCIUM SILICATE AS MFG. IN HAVRE DE GRACE, MD. DURO-TAK 280-2516 AS MFG. IN THE NETHERLANDS REXENE POLYPROPYLENE RADIATION RESISTANCE RESINS, ODESSA, TX SEMEX MD-0129 AS MFG. IN FRAZER, PA CHLORHEXIDINE HYDROCHLORIDE AS MFG. IN HANAU, GERMANY RGH-2957 AS MFG. IN BUDAPEST HUNGARY TES(N-TRIS[ HYRDOXYMETHYL ] METHY 2-AMINOETHANESULFONIC ACID) PSEUDOEPHEDRINE HCL CONTROLLED BEADS AS MFG. IN ST. LOUIS, MO HPLC PURIFIED CALCITONIN-SALMON DRUG SUBSTANCE MFG. IN PA ISOTRETINOIN AS MFG. IN MILAN, ITALY HALOPERIDOL AS MFG. IN FEUCHT, GERMANY ULTRAPURE RECOMBINANT PROTEIN A AS MFG. IN CAMBRIDGE, MA SUCCINIC ACID,DISODIUM HEXAHYDRATE AS MFG.IN SAINT LOUIS, MI IMMOBILIZED RECOMBINANT PROTEIN A AS MFG. IN CAMBRIDGE, MA STATUS Type SUBMIT DATE I I A II I II II 4/28/1988 4/28/1988 4/28/1988 4/19/1988 HOLDER DIOSYNTH INC BIOCHEMIC GESELLSCHAFT MBH ISOCHEM SAS SUBJECT OXYMORPHONE HYDROCHLORIDE AS MFG. IN APELDOORN, NETHERLANDS FERMENTATION PLANT LOCATED IN KUNDL, TYROL, AUSTRIA LOPERAMIDE HYDROCHLORIDE AS MFG. IN GENNEVILLIERS, FRANCE

4Q2012

GREAT LAKES CHEMICAL KONSTANZ GMBH L-VALINE AS MFG. IN KONSTANZ, GERMANY

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4Q2012EXCEL DMF# 7490 7491 7492 7493 7494 I 7495 7496 I 7497 7498 7499 7500 7501 7502 I 7503 I 7504 7505 7506 7507 7508 7509 7510 7511 7512 7513 7514 7515 7516 I 7517 7518 7519 7520 I 7521 7522 7523 7524 7525 A I I I I IV II II II II 6/6/1988 6/6/1988 6/8/1988 6/13/1988 6/12/1988 UNILEVER UNITED STATES INC OMNICHEM SA CHEMISCHE FABRIK BERG GMBH DIOSYNTH BV STEROGENE BIOSEPARATIONS INC I I A II II III II 6/8/1988 6/10/1988 6/9/1988 6/8/1988 BACHEM FEINCHEMIKALIEN AG SOGO PHARMACEUTICAL COMPANY LTD AMPAC FLEXIBLES BIORESEARCH SPA A A I I I I I I I I I I II II III IV II IV I III I II II II I 6/3/1988 6/1/1988 5/31/1988 6/2/1988 6/1/1988 6/1/1988 6/3/1988 6/9/1988 6/6/1988 6/7/1988 6/3/1988 5/19/1988 6/6/1988 II 5/30/1988 I I I I I II II II II II II 5/31/1988 5/27/1988 5/26/1988 5/16/1988 6/2/1988 6/1/1988 A II IV 5/30/1988 5/25/1988 STATUS Type SUBMIT DATE I I A A II II II II II 5/20/1988 5/20/1988 5/22/1988 4/30/1988 5/26/1988 HOLDER FINORGA REPLIGEN CORPORATION CHEMI SPA LONZA BRAINE SA SHANGHAI NO 17 PHARMACEUTICAL FACTORY SIFAVITOR SRL WEI MING PHARMACEUTICAL MANUFACTURING CO LTD BIOGLUCONICS INC FARMABOIS ICFI SPA PENINSULA LABS QUATRUM SUBJECT 6-METHOXY-2-NAPHTHALDEHYDE AS MFG. IN CHASSE-SUR-RHONE FRANCE THERAPEUTIC RECOMBINANT PROTEIN A AS MFG. IN CAMBRIDGE, MA DIFLUNISAL AS MFG. IN FROSINONE, ITALY DESMOPRESSIN ACETATE AS MFG. IN BRAINE-L'ALLEUD BELGIUM INDOMETHACIN AS MFG. IN SHANGHAI, CHINA PYRANTEL PAMOATE AS MFG. IN MILAN, ITALY MICROCRYSTALLINE CELLULOSE AS MFG. IN TAIPEI, TAIWAN, R.O.C. FERROUS GLUCONATE AS MFG. IN CARLSTADT, NEW JERSEY DESOXIMETHASONE AS MFG. IN PAVIA, ITALY BACLOFEN AS MFG. IN (VA) ITALY BETA-HUMAN CHORIONIC-GONADOTROPIN (109-145) IN BELMONT, CA BECLOMETHASONE DIPROPIONATE AS MFG. IN LISBON, PORTUGAL

4Q2012

MEDISORB TECHNOLOGIES INTERNATIONAL TESTOSTERONE INJECTABLE MICROSPHERES MFG. IN CINCINNATI, OH LTD PARTNERSHIP NOBEL CHEMICALS AB DIV FINE CHEMICALS FLUOCINONIDE AS MFG. IN MILAN, ITALY INC MOEHS IBERICA SL NIFEDIPINE AS MFG. IN BARCELONA, SPAIN FABBRICA ITALIANA SINTETICI SPA SILGAN PLASTICS CORPORATION SHIN-ETSU CHEM IND CO LTD EXPANSIA ABITEC CORP PENCO OF LYNDHURST INC HELVOET PHARMA MARYLAND ERCI FACILITIES SERVICES CORP NOVARTIS PHARMACEUTICALS CORP ER SQUIBB AND SONS INC FARCHEMIA BOSTON ANALYTICAL CLONAZEPAM AS MFG. IN VICENZA, ITALY PLASTIC BOTTLES MANUFACTURED IN FRANKLIN, KENTUCKY. HYDROXYPROPYL METHYLCELLULOSE ACETATE SUCCINATE CICLETANINE AS MFG. IN ARAMON, FRANCE BBS, BAKER'S BEST SHORTENING AS MFG. IN COLUMBUS, OHIO FACILITY, PERSONNEL AND PROCEDURES IN LYNDHURST, NEW JERSEY RUBBER CLOSURE FORMUATION B5001-55 GRAY, SALISBURY, MD STORAGE OF CHEMICALS AND DRUGS FOR NCI CONTRACT (N01-CM-73721) STARTING MATERIALS 1 & 3, IN NEW JERSEY AND SWITZERLAND FUNGILIN (AMPHOTERICIN B) ORAL SUSPENSION MFG. IN MORETON,UK N-METHYL-1-METHYLTHIO-2-NITRO ETHENAMINE, TREVIGLIO, ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN EVERETT, MA. H-PHE-0ME HYDROCHLORIDE AS MFG. IN BUDENDORF, SWITZERLAND THIOTEPA AS MFG. IN SAGAMIHARA, JAPAN PACKAGING MATERIALS AS MFG. IN CARY, IL S-ADENOSYL METHIONINE SULFATE P-TOLUENESULFONATE BULK DRUG AND ENTERIC COATED 400 MG TABLET MFG. IN SWITZERLAND AND ITALY EXCIPIENTS FOR CREAMTEX MANUFACTURED IN JOLIET, ILLINOIS. 5-AMINO-SALICYLIC ACID AS MFG. IN WETTEREN, BELGIUM METHENAMINE HIPPURATE AS MFG. IN LUDENSCHEID, GERMANY DEHYDRO ISOANDROSTERONE ACETATE AS MFG. OSS THE NETHERLANDS PURIFICATION CHROMATOGRAPHY MEDIA USED IN THE PREPARATION OF PROTEINS AS MFG IN CARLSBAD, CA. Page 210

4Q2012EXCEL DMF# 7526 7527 7528 I 7529 7530 7531 7532 7533 7534 7535 7536 7537 7538 7539 I 7540 7541 I 7542 7543 7544 7545 7546 7547 I 7548 7549 7550 7551 I 7552 A 7553 7554 7555 7556 7557 7558 7559 7560 7561 I I I I I A A I I II I II II II III IV I I 6/24/1988 6/27/1988 6/29/1988 6/30/1988 6/22/1988 6/28/1988 6/8/1988 6/29/1988 7/4/1988 II 6/21/1988 A I I II II III I 6/21/1988 6/21/1988 6/22/1988 6/21/1988 I I I I I II II II II III II 6/2/1988 6/2/1988 6/15/1988 6/21/1988 6/9/1988 6/22/1988 I II II 6/16/1988 6/21/1988 I I I I I I I I I I II III II II II II II II III I II 6/13/1988 6/8/1988 6/13/1988 6/13/1988 5/23/1988 5/23/1988 6/13/1988 5/17/1988 4/28/1988 6/6/1988 6/9/1988 STATUS Type SUBMIT DATE I I II II II 6/13/1988 6/14/1988 6/14/1988 HOLDER SIGMA F AND D DIV LTD JOHNSON MATTHEY INC SHANGHAI NO 6 PHARMACEUTICAL FACTORY DIOSYNTH BV SILGAN PET CORP IMAGENTS INC DIOSYNTH BV ANTIBIOTICOS SPA ANTIBIOTICOS SPA DIOSYNTH BV LINNEA PHYTOCHEMICALS REEMAY INC ANGELINI FRANCESCO ACR INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA SIEGFRIED AG SHANGHAI NO 6 PHARMACEUTICAL FACTORY ANTIBIOTICOS SPA ANTIBIOTICOS SPA FARMOS GROUP LTD MEDIPOLAR SHOWA DENKO KK AIR PRODUCTS AND CHEMICALS INC INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA FIS FABBRICA ITALIANA SINTETICI SPA KNOLL AG DYMAX CORP NORTHEAST GENERAL PHARMACEUTICAL FACTORY NORTHEAST PHARMACEUTICALS GROUP CO LTD SELOC FRNCE CONTENSIO CHEMICALS GMBH EASTMAN KODAK CO HOECHST MARION ROUSSEL SA TCI AMERICA EXXONMOBIL CHEMICAL CO JAY FLAVORS AB COWLES CO INC IROPHARM LTD SUBJECT DEXTROMETHORPHAN HYDROBROMIDE AS MFG. IN ST. LOUIS , MO. GALLIUM NITRATE AS MFG. IN WEST DEPTFORD, NEW JERSEY RANITIDINE HYDROCHLORIDE MFG. IN SHANGHAI (CHINA) METOLAZONE AS MFG. IN OSS THE NETHERLANDS PACKAGING MATERIALS MFG. IN LOUISVILLE, KY. RADIOCHEMICAL GALLIUM CITRATE GA-67 AS MFG. IN HOUSTON, TEXAS DEHYDRO ISOANDROSTERONE SODIUM SULPHATE AS MFG. IN HOLLAND CABERGOLINE ACTIVE DRUG SUBSTANCE AS MFG. IN MILANO, ITALY CABERGOLINE FINISHED DOSAGE AS MFG. IN MILANO ITALY DEHYDRO ISOANDROSTERONE AS MFG. IN OSS THE NETHERLANDS PILOCARPINE HYDROCHLORIDE AS MFG. IN RIAZZINO, SWITZERLAND SPUNBONDED POLYESTER AS MFG. IN OLD HICKORY, TENNESSEE MFG. SITE AND FACILITIES LOCATED IN APRILIA (LT) ITALY DROPERIDOL AS MFG. IN CARONNO PERTUSELLA (VA) ITALY DILTIAZEN HYDROCHLORIDE AS MFG. IN ZOFINREN, SWITZERLAND CIMETIDINE AS MFG. IN SHANGHAI, PEOPLE'S REPUBLIC OF CHINA THYMIC HUMORAL FACTOR GAMMA 2 ACTIVE DRUG SUBS. - MILAN,ITALY THYMIC HUMORAL FACTOR GAMMA 2 FINISHED DOSAGE, MILAN ITALY CYTARABINE MFG. IN OULU, FINLAND L-5-HYDROXYTRYPTOPHAN AS MFG. IN OITA, JAPAN AIRFLEX 416 EMULSION AS MFG. IN CALVERT CITY, KY. ECONAZOLE NITRATE AS MFG. IN SETTIMO MILANESE, ITALY CLOTRIMAZOLE MANUFACTURED IN VICENZA, ITALY. MEFLOQUINE HYDROCHLORIDE AS MFG. IN LUDWIGSHAFEN, GERMANY PACKAGING MATERIALS ADHESIVES MFG. IN TORRINGTON,CT.

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SHENYANG, PEOPLE'S REP. OF CHINA (#2 AFFILIATED PLANT). SUCRALFATE AS MFG. IN SHENYANG, PEOPLE'S REPUBLIC OF CHINA DIVALPROEX SODIUM AS MFG. IN SHANNON CO. CLARE, IRELAND FACILITY LOCATED AT WITTEN/RUHR, GERMANY (ETHYLENEDINITRILO) TETRAACETIC ACID COPPER DISODIUM SALT BETAMETHASONE AS MFG. IN VERTOLAYE, FRANCE DICHLOROACETIC ACID SODIUM SALT AS MFG. IN PORTLAND, OREGON LOW DENSITY POLYETHYLENEAS MFG. IN MONT BELVIEU, TEXAS ARTIFICIAL FLAVOR FOR ANTIBIOTIC SPRAY DRIED NV-7757 FACILITIES AND OPERATING PROCEDURES AT THE WAYLAND PLANT, N.Y. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ARKLOW, IRELAND. Page

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4Q2012EXCEL DMF# 7562 7563 7564 A 7565 I 7566 7567 7568 7569 7570 7571 7572 7573 7574 7575 7576 7577 7578 7579 7580 7581 7582 7583 7584 7585 7586 7587 I 7588 7589 7590 7591 7592 I 7593 I 7594 I 7595 7596 I I I IV 7/12/1988 7/14/1988 BAXTER HEALTHCARE CORP SCHER CHEMICALS INC FACILITIES IN MORTON GROVE, IL AND BRIDGEPORT, NJ DIISOPROPYL DIMERATE AS MFG. IN CLIFTON, NJ I 7/20/1988 PHARMACEUTICAL DELIVERY SYSTEMS INC MFG. SITE, PERSONNEL AND PROCEDURES IN CHESTERFIELD, MO II 7/13/1988 I I A I II I II II II 7/6/1988 7/13/1988 7/18/1988 7/22/1988 7/18/1988 I I A I I I I I I I I A I I I A I A I I I I II II II III II I I II II II II II II I II I II II II II II 5/9/1988 7/1/1988 7/11/1988 7/13/1988 7/7/1988 7/6/1988 7/6/1988 7/6/1988 7/6/1988 7/12/1988 7/19/1988 7/11/1988 7/7/1988 7/18/1988 7/15/1988 7/15/1988 7/18/1988 7/19/1988 6/29/1988 7/14/1988 7/12/1988 6/27/1988 II 7/4/1988 STATUS Type SUBMIT DATE I I II II II 6/28/1988 7/4/1988 7/1/1988 HOLDER PENICK CORP IROPHARM LTD PARKER HANNIFIN MANUFACTURING LTD DOMNICK HUNTER PROCESS FILTRATION EUROPE LABORATOIRES D'ETUDES ET DE RECHERCHES SYNTHELABO FILTRON TECHNOLOGY CORP ANGUS BIOTECH INC DAIICHI SANKYO CO LTD RALLIS INDIA LTD MAGENTA CORP PAUL SCHERRER INSTITUTE PAUL SCHERRER INSTITUTE POLYPEPTIDE LABS INC RESOLUTION CHEMICALS LTD REXIM SA DIV DEGUSSA MIKAH PHARMA LLC PHARMACHIM ECONOMIC CORP MEDICHEM SA IPCA LABORATORIES PVT LTD IPCA LABORATORIES LTD OWENS ILLINOIS CLOSURE INC INSTITUTO MASSONE S A SCHERING AG EGIS PHARMACEUTICALS PUBLIC LTD CO SINTENOVA SA SUBJECT OPIUM TINCTURE SOLUTION AS MFG. IN NEWARK, NEW JERSEY NIFEDIPINE AS MFG. IN ARKLOW CO. WICKLOW, REPUBLIC OF IRELAND MICROPORUS FILTERS MFG. IN BIRTLEY CO. DURHAM, ENGLAND

4Q2012

CD271 AS MFG. IN GARGENVILLE, FRANCE FACILITIES LOCATED IN CLINTON, MASSACHUSETTS ERYTHROMYCIN AS MFG. IN WILMINGTON, CALIFORNIA PRAVASTATIN SODIUM (CS-514) - ONAHAMA, IWAKI CITY, JAPAN NAPROXEN SODIUM AS MFG. IN GUJARA, INDIA POP-LOK CAPS AS MFG. IN CHICAGO, IL STRONTIUM SR-82 CONCENTRATE MFG. IN WURENLINGEN, SWITZERLAND FACILITIES LOCATED IN WURENLINGEN, SWITZERLAND ANTOCIN AS MFG. IN MALMO SWEDEN AZATHIOPRINE AS MFG. IN WEST YORKSHIRE, UNITED KINGDOM GLYCINE HYDROCHLORIDE AS MFG. IN HAM, FRANCE LOXAPINE SUCCINATE AS MFG. IN SOUTH HAVEN, MICHIGAN TOBRAMYCIN BASE AS MFG. IN SOFIA, BULGARIA PROBUCOL AS MFG. IN CELRA (GERONA) SPAIN FACILITY IBD-D IN PIN., INDIA METOCLOPRAMIDE HCL AS MFG. IN RATLAM, MADHYA PRADESH, INDIA FACILITY LOCATED IN FORT WORTH, TEXAS MENOTROPIN MANUFACTURED IN BUENOS AIRES, ARGENTINA. DANAZOL AS MFG. IN BERKAKAMEN, GERMANY PIROXICAM AS MFG. IN BUDAPEST, HUNGARY ATENOLOL AS MFG. IN BARCELONA, SPAIN

SMITHKLINE BEECHAM PHARMACEUTICALS PENN CHEMICALS PRODUCTION FACILITY IN COUNTY CORK, IRELAND

RHONE POULENC PHARMACEUTICALS RP SPIRAMYCIN SYRUP AS MFG. IN SAINT-GENIS-LAVAL, FRANCE INC STOLLE RESEARCH & DEVELOPMENT CORP NORETHINDRONE INJECTABLE MICROSPHERES - CINCINNATI, OHIO DS INDUSTRIE APS EXCELLA GMBH FRANCIS SPA SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT TANABE SEIYAKU CO LTD FACILITY FOR THE PRODUCTION OF LIPID ESTERS,COPENHAGEN,DENMARK CLOMIPHENE-CITRATE (ESUB) AS MANUFACTURED IN FEUCHT,GERMANY ATENOLOL AS MFG. IN CARONNO, PERTUSELLA (VA) ITALY THIETHYLPERAZINE MALEATE AS MFG. IN BASLE, SWITZERLAND BENZYL S-1,2,3,4-TETRAHYDROISOQUINOLINE-3-CARBOXYLATE P-TOLUENESULFONIC ACID SALT (THIQ) AS MFG. IN ONODA CITY, YAMAGUCHI PREFECTURE, JAPAN

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4Q2012EXCEL DMF# 7597 7598 A 7599 7600 7601 I 7602 I 7603 7604 7605 7606 7607 7608 7609 7610 7611 7612 7613 I 7614 7615 I 7616 7617 7618 A 7619 I 7620 7621 7622 7623 I 7624 7625 I 7626 7627 7628 7629 I I I I I II IV II 8/12/1988 8/15/1988 8/3/1988 8/12/1988 A III II 7/25/1988 8/9/1988 PYUNGHWA MEDICAL PRECISION CO LTD MALLINCKRODT PHARMS DIV MALLINCKRODT INC PHARMACIA HEPAR INC BACHEM FINE CHEMICALS INC JAY FLAVORS I I I II II II I 8/9/1988 7/29/1988 8/11/1988 7/25/1988 KABI PHARMACIA AB IRFI SPA ASAHI CHEM INDUSTRY CO LTD PYUNGHWA SPECIAL RUBBER CO LTD I 7/19/1988 WIPF AG I A II II IV 8/8/1988 8/2/1988 8/1/1988 I II II 8/8/1988 7/29/1988 I I I I I I I A I I II II II II I II II III II II II 7/28/1988 6/30/1988 7/27/1988 7/28/1988 7/29/1988 7/28/1988 8/2/1988 8/3/1988 8/2/1988 8/3/1988 8/2/1988 SYNTHO RIFA PVT LTD PROQUINA SA SANDOZ PHARMS CORP DIV SANDOZ INC LINZ INSTITUTE INC BIOMEASURE INC CHEMDEX INC TEVA PHARMACEUTICAL INC LOPAREX LLC BASF AKTIENGESELLSCHAFT HEINRICH MACK NACHF WISCONSIN ANALYTICAL & RESEARCH SERVICES LTD CHANTAL PHARMACEUTICAL CORP LABORATOIRES D'ETUDES ET DE RECHERCHES SYNTHELABO BENZEX LABS LTD ISOCHEM SAS LUBRIZOL ADVANCED MATERIALS INC I 7/28/1988 A A II II II 7/21/1988 7/18/1988 7/29/1988 COSMA SPA ZACH SYSTEM SPA FUJISAWA PHARMACEUTICAL COMPANY LTD SYNTHO RIFA PVT LTD KETOPROFEN (ESUB) AS MANUFACTURED IN CISERANO (BERGAMO) ITALY DILTIAZEM HYDROCHLORIDE AS MFG. IN (VICENZA) ITALY FK506 (FK900506) DOSAGE FORMS MFG. IN AICHI-KEN & OSAKA JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GUJARA, INDIA. RIFAMPIN AS MFG. IN GUJARA, INDIA DANAZOL AS MFG. IN IXTACZOQITLAN, VER. MEXICO THIAMYLAL SODIUM MFG. IN TYROL, AUSTRIA IMINODIBENZYL AS MFG. IN LINZ, AUSTRIA MANUFACTURING FACILITIES LOCATED IN HOPKINTON, MASSACHUSETTS IRON DEXTRAN SOLUTION 5% (50 MG/ML) AS MFG. IN LENEXA, KS CO-POLYMER-1 (COP-1) AS MFG. IN NETANYA, ISRAEL 10976 S 63# BL KFT L/00 4D/000 46928-BASF, BENZOIC ACID AS MFG. IN LUDWIGSHAFEN GERMANY ALEXAN 1000 MG/20 ML VIAL (5% CYTARABINE SOLUTION) W. GERMANY DETERMINATION OF HYDROCHLOROTHIAZIDE IN HUMAN URINE ETHOCYN AS MFG. IN CAROLINA, PUERTO RICO (S)-BETAXOLOL HYDROCHLORIDE INFO TRANS. TO D5464 ON 9/2/88 NAPROXEN AS MFG. IN BOLLARAM NARSAPUR T.Q MEDAK, INDIA AMIODARONE HYDROCHLORIDE AS MFG. IN GENNEVILLIERS, FRANCE STATUS Type SUBMIT DATE I II II 6/27/1988 7/29/1988 HOLDER AJINOMOTO CO INC FINE CHEMICALS CORP PTY LTD SUBJECT INTRAVENOUS LENTINAN AS MFG. IN YOKKAICHI, JAPAN

4Q2012

PROCHLORPERAZINE DIMALEATE MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA.

NOVEON AA-1 (R) FORMERLY CARBOPOL 976) AS MANUFACTURED IN CALVERT CITY, KY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CH-8604 VOLKETSWIL, SWITZERLAND MICTURO (TERODILINE HYDROCHLORIDE) 12.5MG TABS MANUFACTURED IN SWEDEN. EASFOSFINA MANUFACTURED IN ROMA, ITALY. 1-(2,4-DIFLUOROPHENYL)-6, 7 DIFLUORO-1,4-DIHYDRO-4-OXOQUINOLINE-3-CARB MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KYUNGKI-DO, KOREA. ELASTOMERIC CLOSURES MFG. IN KYUNGKI-DO, KOREA LEVORPHANOL TARTRATE AS MFG. IN ST. LOUIS, MISSOURI NUCLEIC ACIDS MANUFACTURED IN FRANKLIN, OHIO. BIOMEASURE SOMATOSTATIN ANALOG AS MFG. IN TORRANCE, CA FLAVOR FOR ANTIBIOTIC SPRAY DRIED NV-7759, S. PLAINFIELD, NJ.

FUJISAWA PHARMACEUTICAL COMANY LTD FK973 DRUG SUBSTANCE AND DRUG PRODUCT IN AICHI & OSAKA, JAPAN

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4Q2012EXCEL DMF# 7630 7631 7632 7633 7634 7635 7636 7637 7638 7639 7640 I 7641 7642 7643 I 7644 7645 7646 7647 7648 7649 7650 7651 7652 I 7653 7654 7655 7656 7657 7658 7659 7660 7661 7662 7663 7664 7665 I 7666 7667 I I III II 9/14/1988 9/12/1988 ALPHAGARY CORP DIOSYNTH BV I I A I I A I I I I I I II II II I I II II II II II III III I 8/24/1988 9/2/1988 9/1/1988 8/31/1988 8/24/1988 9/6/1988 9/6/1988 8/31/1988 9/12/1988 9/7/1988 9/6/1988 9/8/1988 8/22/1988 BETATENE LTD WYCKOFF CHEMICAL CO INC CAMBREX CHARLES CITY INC BARRE NATIONAL INC VENTURE MOLDED PRODUCTS INC FERRO PFANSTIEHL INC QP CORP SIBEFAT SPA UNICHEM LABORATORIES LTD SIGMA F AND D DIV LTD 3M PHARMS B BRAUN MEDICAL INC BEA FILTRI S P A I I I I I I I A III II II III I I II II II 8/25/1988 8/22/1988 8/23/1988 3/10/1988 8/25/1988 6/30/1988 8/23/1988 8/22/1988 8/26/1988 I I III II II 8/26/1988 8/23/1988 8/17/1988 SPA SAFTA WOCKHARDT LTD INSTITUTO BIOLOGICO CHEMIOTERAPICO SPA DIV UNIBIOS COMAR INC ALDRICH CHEMICAL COMPANY INC MALLINCKRODT CHEMICAL INC MALLINCKRODT INC ALPHA ONE BIOMEDICALS INC PHARMACIA LEO PHARMACEUTICALS REXOLIN CHEMS AB BLANVER FARMOQUIMICA LTDA GANES CHEMICALS INC STATUS Type SUBMIT DATE I I I I I I I I I I I II III III II II I III II II I 7/29/1988 8/5/1988 8/10/1988 8/16/1988 8/15/1988 8/23/1988 8/25/1988 8/17/1988 8/15/1988 8/17/1988 8/22/1988 HOLDER ATOMIC ENERGY OF CANADA LTD KV PHARMACEUTICAL CO LAWSON MARDON GROUP LTD MAR CO INDUSTRIES CORP ALDRICH CHEMICAL COMPANY INC WM WRIGLEY JR CO ZENECA PHARMACEUTICALS ZAPPA PLASTICS INC FARMOS GROUP LTD MEDIPOLAR DINAMITE DIPHARMA SPA IODENT CO SUBJECT ISOTOPE PRODUCTION DEPARTMENT FACILITY IN KANATA, CANADA CLONIDINE HYDROCHLORIDE CONTROLLED RELEASE CAPSULES 0.2 MG. FOIL LIDDING AS MFG. IN TORONTO, ONTARIO, CANADA PACKAGING MATERIALS AS MFG. IN PUERTO REAL, FAJARDO, PUERTO RICO 1(2PHENYLETHYL)4(N(2PYRAZYL)2(FUROYLAMIDO)PIPERIDINE HCL EXTRA SUGARFREE CHEWING GUM CONTAINING FLOURIDE - CHICAGO, IL FACILITY LOCATED IN NEWARK, DELAWARE PACKAGING MATERIALS MANUFACTURED IN PHILLIPSBURG, NJ. GLYBURIDE AS MFG. IN OULU, FINLAND PENTOXIFYLLINE AS MFG. IN MILAN, ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RANTOUL, ILLINOIS. ALUMINUM FOIL PACKAGING MATERIALS AS MFG. IN PIACENZA, ITALY NIACIN AS MFG. IN ANKLESHWAR, INDIA DOXOFYLLINE AS MFG. IN TRECATE, ITALY PACKAGING MATERIALS MFG. IN VINELAND, NEW JERSEY. Q1196-9 AS MFG. IN MILWAUKEE, WISCONSIN DEXTROCET-N2000 AS MFG. IN ST. LOUIS, MO WEST COMPANY'S 20MM 890 GREY STOPPER FACILITIES UTILLIZED AT THE FOSTER CITY, CA LOCATION FACILITIES, PERSONNEL AND PROCEDURES IN HELSINGBORG, SWEDEN PIPERANZINE PHOSPHATE AS MFG. IN HELSINGBORG, SWEDEN

4Q2012

TABLO (SODIUM STARCH GLYCOLATE NF/BP) MANUFACTURED IN COTIA, BRAZIL. DEXBROMPHENIRAMINE MALEATE MANUFACTURED IN PENNSVILLE, CARLSADT, NEW JERSEY. BETA CAROTENE MANUFACTURED IN VICTORIA AND WHYALLA AUSTRALIA. NICOTINE POLACRILEX AS MFG. IN SOUTH HAVEN, MI 5-AMINOSALICYLIC ACID MANUFACTURED IN CHARLES CITY, IOWA. FACILITIES, PERSONNEL AND PROCEDURES IN BALTIMORE, MD FACILITIES FOR PACKAGING MATERIALS MFG. IN WEST TRENTON, NJ SODIUM LACTATE MANUFACTURED I WAUKEGAN, ILLINOIS. EGG YOLK PHOSPHATIDYL CHOLINE AS MFG. IN TOYKO, JAPAN PIROXICAM AS MFG. IN TRIBIANO (MILANO) ITALY DIPHENHYDRAMINE HYDROCHLORIDE AS MFG. IN BOMBAY, INDIA BRADYKININ ACETATE SALT AS MFG. IN ST. LOUIS, MO SCOTCHPAK BRAND FILM NO. X-443 AS MFG. IN ST. PAUL, MN MCGAW 4 LITER PLASTIC CONTAINER AS MFG. IN IRVINE, CA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PERO (MILANO) ITALY. PACKAGING MATERIALS MFG. IN NEWARK, NJ BETAMETHASONE DIPRIONATE AS MFG. IN OSS, HOLLAND

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4Q2012EXCEL DMF# 7668 7669 7670 I 7671 I 7672 7673 I 7674 7675 7676 7677 7678 7679 7680 7681 7682 7683 7684 7685 7686 7687 7688 7689 7690 7691 7692 7693 7694 7695 7696 7697 7698 7699 7700 7701 I 7702 7703 7704 7705 I I I A II II II IV 10/11/1988 10/4/1988 10/12/1988 9/30/1988 I A I I A I I I I I I I A I I I I I I I A I I I I I I I II II II II II II I II I II III II II I II II II III IV II II IV II II II II II 9/14/1988 9/16/1988 9/15/1988 10/21/1988 9/16/1988 9/15/1988 9/23/1988 9/15/1988 9/20/1988 9/16/1988 9/16/1988 9/16/1988 9/22/1988 9/15/1988 8/18/1988 9/21/1988 9/21/1988 9/26/1988 9/23/1988 9/23/1988 9/30/1988 9/29/1988 9/29/1988 9/29/1988 9/29/1988 10/3/1988 10/1/1988 10/5/1988 HR CENCI LABORATORIES INC CAMBREX PROFARMACO MILANO SRL REINO CHEMICAL INDUSTRIAL CORP BOMBAY DRUG HOUSE LTD DIPHARMA FRANCIS SRL SIGMA F AND D DIV LTD RAYLO CHEMICALS DIBRA SPA INALCO SPA SALARS SPA SALARS SPA SOUTHERN RESEARCH INSTITUTE CU CHEMIE UETIKON GMBH SIGMA F AND D DIV LTD RORER HLTH CARE UK LTD SIGMA F AND D DIV LTD SIGMA F AND D DIV LTD CHEMWERTH REXAM CLOSURES SYSTEMS INC B BRAUN MEDICAL INC AJINOMOTO PHARMACEUTICALS CO LTD PHARMECO LABS INC DS INDUSTRIE APS ESTEVE QUIMICA SA TEIKOKU CHEM INDUSTRY DIOSYNTH BV APPLIED LABORATORIES INC I III I 9/13/1988 9/21/1988 ROBERTS & CARLSON INC BEIERSDORF - LILLY GMBH I 9/14/1988 STATUS Type SUBMIT DATE I A II II I 9/6/1988 9/9/1988 9/12/1988 HOLDER ALDRICH CHEMICAL COMPANY INC COSMA SPA HERBERT LABORATORIES DIV SMITH KLINE & FRENCH CO FAULDING HOSPITAL PRODUCTS INC SUBJECT

4Q2012

6- HYDROXYDOPAMINE HYDROBROMIDE MANUFACTURED IN MILWAUKEE, WISCONSIN. PYRANTEL PAMOATE (ESUB) AS MANUFACTURED. IN CISERANO (BERGAMO) ITALY FACILITIES, SITE AND PERSONNEL UTILLIZED IN IRVINE, CA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN AGUADILLA, PUERTO RICO. LOKFLEX II PRIMER AS MFG. IN CLIFTON, NJ MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HAMBURG, GERMANY FOR MOXONIDINE. FACILITIES, PERSONNEL AND PROCEDURES UTILLIZED IN FRESNO, CA GLYBURIDE AS MFG. IN PAULLO (MILANO) ITALY ACETAMINOPHEN AS MFG. IN TAIWAN, REPUBLIC OF CHINA TRIMETHOPRIM AS MFG. IN BOMBAY, INDIA GLYBURIDE AS MFG. IN MILANO, ITALY INSULIN FROM BOVINE PANCREAS AS MFG. IN ST. LOUIS, MO 2',3'-DIDEOXYINOSINE AS MFG. IN EDMONTON ALBERTA, CANADA FACILITIES UTILIZED IN MILANO, ITALY PURIFIED LACTULOSE SYRUP AS MFG. IN PISTOIA, ITALY FACILITIES UTILIZED IN COMO, ITALY BUPRENORPHINE HYDROCHLORIDE MANUFACTURED IN COMO, ITALY. INTRA-ORAL FLUORIDE-RELEASING DEVICES - BIRMINGHAM, ALABAMA KETAMINE HYDROCHLORIDE AS MFG. IN LAHR, GERMANY INOSINE AS MFG. IN ST. LOUIS, MO FACILITIES UTILIZED IN EASTBOURNE, EAST SUSSEX, UK ISONICOTINIC ACID HYDRAZIDE AS MFG. IN ST. LOUIS, MO D (-) PENICILLAMINE AS MFG IN ST. LOUIS,MO PROPANTHELINE BROMIDE AS MFG. BY PENCO IN LYNDHURST, NJ CONTAINER/CLOSURE SYSTEMS AS MFG IN MAUMEE PLANT STERILIZATION OF GLASS MFG. IN IRVINE, CA 2'3'-DIDEOXYINOSINE AS IN MIE-PREFECTURE AND KANAGAWA, JAPAN DTPA BIS (METHYLAMIDE) AND ITS SALTS MFG. IN SIMI VALLEY, CA ESTARAM'S INACTIVE DRUG INGREDIENTS MFG. IN COPENHAGEN, DK PIROXICAM AS MFG. IN BARCELONA, SPAIN THYMIDINE AS MFG. IN OSAKA, JAPAN PRAZEPAM AS MFG. IN OSS, HOLLAND BLAIREX BRONCHO SALINE AS MFG. IN COLUMBUS, INDIANA

STOLLE RESEARCH & DEVELOPMENT CORP TETRACYCLINE BIODEGRADABLE MICROSPHERES MANUFACTURED IN CINCINNATI, OHIO. BEIERSDORF GMBH MOXONIDINE AS MFG. IN HAMBURG, GERMANY ORION CORP LTD FERMION VICTREX USA INC CREMER OLEO GMBH AND CO KG PENTOXIFYLLINE AS MFG. IN ESPOO AND HANKO, FINLAND POLYETHERETHERKETONE (PEEK) AS MFG. IN LANCASHIRE, ENGLAND SOFTIGEN 767 EXCIPIENTS AS MFG. IN WITTEN/RUHR, GERMANY

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4Q2012EXCEL DMF# 7706 7707 7708 I 7709 7710 7711 7712 I 7713 I 7714 I 7715 7716 7717 7718 7719 7720 7721 7722 7723 7724 7725 I 7726 7727 7728 7729 7730 I 7731 7732 7733 7734 7735 7736 7737 7738 7739 7740 I I I I A I I I I I I IV IV II III III I II II I 9/1/1988 10/31/1988 10/27/1988 10/31/1988 10/11/1988 10/11/1988 10/21/1988 10/21/1988 10/18/1988 11/1/1988 FERROSAN A/S CAPSULE TECHNOLOGY PUERTO RICO INC DS INDUSTRIE APS DSM NUTRITIONAL PRODUCTS LTD SCHUBERT SEALS A/S SCHUBERT SEALS A/S GIVAUDAN CORPORATION GIVAUDAN CORPORATION AMINO GMBH NOVARTIS I I A I II III II III III 10/6/1988 10/13/1988 10/25/1988 10/28/1988 10/18/1988 SIMS MEDICAL MOLDING CORP AMERICA PHARMA WALDHOF GMBH NATIONAL LABEL CO EXXONMOBIL CHEMICAL CO I I I I I I I I I I III II II I II II II II IV II III 10/7/1988 10/18/1988 10/18/1988 10/17/1988 10/17/1988 10/17/1988 10/20/1988 10/20/1988 10/27/1988 10/25/1988 10/21/1988 I 10/11/1988 II 10/12/1988 I A I II II II II 10/13/1988 10/13/1988 10/7/1988 10/12/1988 STATUS Type SUBMIT DATE I I I II I 10/13/1988 10/12/1988 10/11/1988 HOLDER CYGNUS RESEARCH CORP INDUSTRIAS QUIMICAS TAUBATE SA WHITEHALL LABS DIV AMERICAN HOME PRODS CORP LINNEA PHYTOCHEMICALS CAMBREX PROFARMACO MILANO SRL MITSUBISHI KASEI CORP RP SCHERER NORTH AMERICA DIV RP SCHERER CORP RP SCHERER NORTH AMERICA DIV RP SCHERER CORP WAITAKI INTERNATIONAL BIOSCIENCES SUB WAITAKI CANADA LTD TEKNI PLEX INC ROUSSEL-UCLAF CIPLA LTD SANOFI CHIMIE FRANCIS SPA RP SCHERER CORP FABBRICA ITALIANI SINTETICI SPA SUMIKA FINE CHEMICALS CO LTD AIR PRODUCTS AND CHEMICALS INC RESOLUTION CHEMICALS LTD LOPAREX INC SUBJECT FACILITIES AND MFG. SITE UTILIZED IN REDWOOD CITY, CA ISOSORBIDE DINITRATE AS MFG. IN SSAO PAULO. BRASIL FACILITY LOCATED IN GUAYAMA, PUERTO RICO

4Q2012

PILOCARPINE NITRATE MANUFACTURED IN RIAZZINO (LOCARNO) SWITZERLAND. GLIPIZIDE AS MFG. IN PAULLO (MILANO) ITALY REPIRINAST (MY-5116) DRUG SUBSTANCE, KASHIMA-GUN, JAPAN NIFEDIPINE SOFTGELS 20 MG AS MFG. IN CLEARWATER, FL NIFEDIPINE SOFTGELS 10 MG AS MFG. IN CLEARWATER, FL FACILITIES UTILIZED IN TORONTO, ONTARIO, CANADA PVC COMPOUNDS AS MFG. IN RIDGEFIELD, NEW JERSEY BETAMETHASONE ACETATE AS MFG. IN VERTOLAYE, FRANCE METAPROTERENOL SULFATE AS MFG. IN VARIOUS SITES IN INDIA FACILITIES LOCATED IN SISTERON, FRNACE CROMOLYN SODIUM AS MFG. IN VARESE, ITALY MAXEPA OIL MFG. IN MARFLEET, ENGLAND TRIMETHOBENZAMIDE HYDROCHLORIDE AS MFG. IN VICENZA, ITALY PRAZOSIN HYDROCHLORIDE (POLYHYDRATE) MFG. IN GIFU, JAPAN PERFLUOROPERHYDROPHENANTHRENE EXCIPIENT MFG. IN ALLENTOWN, PA BACLOFEN RAW MATERIAL AS MFG. IN SUFFOLK, UK 10420, 3 MIL CL PET 4N/000 MANUFACTURED IN IOWA CITY, IOWA AND BEDFORD, ILLINOIS. AMILORIDE HCL AS MFG. IN FIRENZE, ITALY PLASTIC MATERIALS AND COLORANTS AS MFG. IN COSTA MESA, CA ADENOSINE AS MFG. IN MANNHEIM, GERMANY NONPARENTERAL METAL PCAKAGING AS MFG. IN LAFAYETTE HILL, PA SANTOPRENE THERMOPLASTIC RUBBER 180 & 280 GRADE SERIES MFG. IN PENSACOLA FL, WADSWORTH OH AND NEWPORT WALES UK FACILITES AND GENERAL OPERATING PROCEDURES IN SOEBORG, DENMARK EMPTY HARD GELATIN CAPSULES AS MFG. IN PUERTO RICO ESTARAM 299 AS MFG. IN COPENHAGEN, DENMARK TRETINOIN (ALL-TRANS-RETINDE, ACID) AS MFG IN BASLE, SWITZERLAND. RUBBER SHEET LAMINATE FROM COUMPOUND 6377 MFG. IN DENMARK RUBBER SHEET LAMINATE FROM COMPOUND 6377/42022 IN DENMARK FACILITIES AND PROCEDURES IN VERNIER, SWITZERLAND PARSOL MCX AS MFG. IN VERNIER, SWITZERLAND BETAINE HCL AS MFG. IN HELMSTEDT, F.R. GERMANY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GRIMSBY, UK

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4Q2012EXCEL DMF# 7741 I 7742 I 7743 7744 7745 7746 7747 7748 7749 7750 7751 I 7752 I 7753 7754 I 7755 7756 7757 A 7758 7759 7760 A 7761 7762 7763 I 7764 7765 7766 7767 7768 I 7769 7770 7771 7772 7773 7774 I I I I I A I II II III II IV 11/16/1988 11/21/1988 11/8/1988 11/21/1988 10/31/1988 11/15/1988 ROCHE PRODUCTS INC LINNEA PHYTOCHEMICALS SIGMA F AND D DIV LTD FRESENIUS USA INC IAF BIOCHEM INTERNATIONAL INC CAPSUGEL I I A I II IV II III I 11/22/1988 11/18/1988 11/18/1988 11/17/1988 11/16/1988 I I II II II 11/22/1988 11/21/1988 11/15/1988 SUMIKA FINE CHEMICALS CO LTD SUMIKA FINE CHEMICALS CO LTD HARTINGTON CHEMICALS DIV STAVELEY CHEMICALS LTD FRANCIS SPA HERCULES INC SIEGFRIED LTD GLASS CORP AMERICA PRODUITS ROCHE SA I I III II III 11/4/1988 10/28/1988 10/5/1984 AUTOMATIC INJECTION MOLDING INC FERMION OY DUPONT TEIJIN FILMS US LP I I II II IV 11/14/1988 10/28/1988 11/9/1988 I I II 11/15/1988 11/7/1988 II 11/7/1988 RP SCHERER NORTH AMERICA DIV RP SCHERER CORP CELLTEC LABS LTD RP SCHERER NORTH AMERICA DIV RP SCHERER CORP SIEGFRIED AG PCAS LUBRIZOL ADVANCED MATERIALS INC I I I A I I I I I II II II IV II II II I 11/3/1988 10/25/1988 10/31/1988 11/8/1988 11/9/1988 10/25/1988 11/8/1988 10/28/1988 11/4/1988 II 11/1/1988 STATUS Type SUBMIT DATE II 11/1/1988 HOLDER RP SCHERER NORTH AMERICA DIV RP SCHERER CORP RP SCHERER NORTH AMERICA DIV RP SCHERER CORP SIGNA SA FREEDOM CHEMICAL DIAMALT GMBH PENINSULA LABS PHARMACIA AND UPJOHN INC DS INDUSTRIE APS KOREA STEEL CHEMICAL COMPANY LTD EASTMAN KODAK CO SOL PHARMACEUTICALS LIMITED GOODWIN INST SUBJECT NIFEDIPINE SOFTGELS 10 MG, TO SUPPORT CHELSEA LABS. ANDA NIFEDIPINE SOFTGELS 20 MG, TO SUPPORT CHELSEA LABS. ANDA MFG. SITE, FACILITIES AND PERSONNEL UTILIZED IN TOLUCA, MEXICO CARBAMAZEPINE AS MFG.. IN RAUBLING, F.R. GERMANY BETA-ENDORPHIN MFG. IN BELMONT, CA NICOTINE TRANSDERMAL DELIVERY SYSTEM MFG. IN REDWOOD CITY, CA Z-ESTARAM AS MFG. IN COPENHAGEN, DENMARK YELLOW PHENOLPHTHALEIN AS MFG. IN KYUNGSANGBUK-DO, KOREA RHODAMINE 123 AS MFG. IN ROCHESTER, NY ALBUTEROL SULPHATE AS MFG. IN ANDHRA PRADESH, INDIA MANUFACTURING SITE, FACILITES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PLAATION, FLORIDA. NIFEDIPINE SOFTGELS 20 MG, KALIPHARMA, INC. MFG. IN FLORIDA FACILITIES UTILIZED IN MADRAS, INDIA

4Q2012

NIFEDIPINE SOFTGELS 10 MG MANUFACTURED BY KALIPHARMA INC IN FLORIDA. DIBENZOSUBERENONE AS MFG. IN ZOFINGEN, SWITZERLAND DILTIAZEM HYDROCHLORIDE MANUFACTURED IN LONGJUMEAU FRANCE CARBOPOLS 1342 AND 1382 AND PEMULEN BASE TR-1 AND TR-1 MANUFACTURED IN CALVERT CITY, KY PACKAGING MATERIALS AS MFG. IN BECKELEY HEIGHTS, NJ CYCLOBENZAPRINE HCL AS MFG. IN ESPOO AND HANKO, FINLAND POLYESTER FILMS AS MANUFACTURED IN DUMFREES,SCOTLAND, HOPEWELL VA, RICHMOND VA, FLORENCE SC, AND GIFU, JAPAN PROBUCOL AS MFG. IN GIFU PREFECTURE, JAPAN PRAZOSIN HCL (BETA-FORM) AS MFG. IN THE GIFU PREFECTURE,JAPAN ACETAMINOPHEN DC-PGS AS MFG. IN DEESIDE, CLWYD, U. K. GEMFIBROZIL AS MFG. IN CARONNO PERTUSELLA (VA) ITALY HERCULES RS, AS AND SS NITROCELLULOSE AS MFG. IN PARLIN, NJ NICOTINE MANUFACTURED IN ZOFINGEN, SWITZERLAND. AMPULES AS MFG. IN AMADORA, PORTUGAL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FONTENAY-SOUS-BOIS, FRANCE. FACILITIES UTILIZED IN DALRY, SCOTLAND CYTARABINE AS MFG. IN RIAZZINO (LOCARNO) SWITZERLAND A-KETOISOCAPROIC ACID, SODIUM SALT AS MFG. IN ST.LOUIS, MO PACKAGING OF SVP AND LVP PRODUCTS IN OGDEN, UTAH SYNTHETIC GLUCAGON HYDROCHLORIDE HUMAN MFG. IN CANADA GELATIN CAPSULES MANUFACTURED IN SUZHOU, PEOPLE'S REPUBLIC OF CHINA.

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4Q2012EXCEL DMF# 7775 7776 7777 7778 7779 7780 7781 7782 7783 7784 7785 7786 7787 7788 7789 7790 7791 7792 7793 7794 7795 I 7796 7797 7798 7799 7800 7801 7802 7803 7804 7805 I 7806 7807 7808 7809 7810 I 7811 7812 I I II II 12/8/1988 12/9/1988 I I I A II III I II II 12/5/1988 10/31/1988 12/13/1988 12/12/1988 12/20/1988 SIGMA F AND D DIV LTD ALMEXA ALUMINIO SA MINIPAK AEROSOLS LIMITED FDC LTD I I I A I A I I I I I II II III II II II II I 12/5/1988 12/15/1988 1/10/1989 12/2/1988 11/22/1988 12/8/1988 11/28/1988 11/28/1988 12/6/1988 11/25/1988 STATUS Type SUBMIT DATE I I I I I I I I I I I I I I I A I I I I IV II II II II III II IV IV I II II II II IV II I II II II II 11/16/1988 11/4/1988 11/18/1988 11/16/1988 11/4/1988 10/31/1988 11/21/1988 11/17/1988 11/17/1988 11/25/1988 12/6/1988 11/18/1988 11/7/1988 11/23/1988 11/30/1988 11/28/1988 11/23/1988 11/28/1988 11/28/1988 11/29/1988 11/23/1988 HOLDER NIPPON FINE CHEMICAL COMPANY LTD REXOLIN CHEMS AB MEDEA RESEARCH LABS SIEGFRIED USA INC NATL INST HLTH ADAMHA DOC REXHAM CORP RAYLO CHEMICALS BASF CORPORATION BASF CORPORATION GRIFFITH MICRO SCI LTD ORGANICHEM CORP SIGMA F AND D DIV LTD SIGMA F AND D DIV LTD CHANDRA PHARMACEUTICALS LTD DS INDUSTRIE APS BASF PHARMA EVIONNAZ SA STERLING DRUG LTD CYGNUS INC CYTEC INDUSTRIES INC KATSURA CHEMICAL CO LTD SUBJECT PHOSPHOLIPID DPPC AS MFG. IN HYOGO, JAPAN PIPERAZINE ADIPATE AS MFG. IN HELSINGBORG, SWEDEN POLYTHIAZIDE MANUFACTURED IN WESTHAMPTON BEACH, NEW YORK. OMOCONAZOLE NITRATE MANUFACTURED IN ZOFINGEN, SWITZERLAND. OMEGA-3 FATY ACID ETHYL ESTERS SUBMITTED FOR FOTMAC PACKAGING MATERIALS AS MFG. IN WESTFIELD, MASSACHUSETTS 3-DEOXYTHYMIDIN-2-ENE AS MFG. IN EDMONTON, ALBERTA, CANADA BUTOFAN NS 222 AS MFG. IN CHATNOOGA, TN STYROFAN ND 487 MANUFACTURED IN CHATTANOOGA, TENNESSEE. FACILITIES LOCATED IN DERBYSHIRE, ENGLAND PHENYLEPHIRINE OXAZOLIDINE AS MFG. IN RENSSELAER, NY D (+) GALACTOSE PRODUCT NO. G 0750 FD AS MFG. IN ST. LOIUS,MO L-ALPHA-PHOSPHATIDYLCHOLINE TYPE XIII-E MDG. IN MISSOURI IBUPROFEN MANUFACTURED IN ANDHRA PRADESH, INDIA. MCT OILS MANUFACTURED IN COPENHAGEN, DENMARK. PHENELZINE SULFATE MANUFACTURED IN EVIONNAZ, SWITZERLAND. FACILITIES UTILIZED IN AURORA, ONTARIO, CANADA FEMPACH ESTRADIOL TRANSDERMAL SYSTEM SPECTRA-SORB UV-9 (OXYBENZONE) - WILLOW ISLAND, WEST VIRGINIA PINDOLOL AS MFG. IN ZAMA-CITY, KANAGAWA PREF. JAPAN

4Q2012

PROSINTEX INDUSTRIE CHIMICHE ITALIANE PRAZOSIN HYDROCHLORIDE AS MFG. IN MILANO, ITALY S.R.L SANOFI RECHERCHE FACILITIES UTILIZED IN MONTPELLIER, FRANCE SANDOZ INDIA LTD PCR INC KYOWA HAKKO BIO CO LTD HELVOET PHARMA MARYLAND MITSUBISHI TANABE PHARMA CORP IROPHARM LTD IROPHARM LTD CADILA LABORATORIES PVT LTD MICRON MILLS LTD MFG. SITE AND FACILITIES UTILIZED IN BOMBAY, INDIA FLOXURIDINE MANUFACTURED IN GAINESVILLE, FLORIDA. MANUFACTURING AND QUALITY INFORMATION ON L-GLUTATHIONE OXIDIZED RUBBER CLOSURE FORMULATION LZ516 AS MFG. IN SALISBURY, MD MCI-9038 ARGATROBAN DRUG SUB.- IBRAKI PREFECTURE, JAPAN AMITRIPTYLINE HCL B.P. 88/USP AS MFG. IN WICKLOW, IRELAND ACEPROMAZINE MALEATE B.P. VET. AS MFG. IN WICLKOW, IRELAND MEBENDAZOLE AS MFG. IN GUJARA, INDIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KENT, ENGLAND. B-NICOTINAMIDE ADENINE DINUCLEOTIDE MANUFACTURED IN ST. LOUIS, MO PHAR 2000 (PHAR 9425) AS MFG. IN MEXICO FACILITY LOCATED IN CHESHIRE, UNITED KINGDOM ALBUTEROL SULFATE MANUFACTURED IN MAHARASHTRA STATE, INDIA.

CIBA GEIGY CORP PHARMACEUTICAL 3-CHLOROIMINODIBENZYL AS MFG. IN GRIMSBY, THE UK DIVISION ORION COPORATION FERMION OULU PLANT TERFENADINE AS MFG. IN OULU, FINLAND ABBOTT LABORATORIES PHARMACEUTICAL PENTIGETIDE MANUFACTURED IN CHICAGO, ILLINOIS. PRODUCTS DIV

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4Q2012EXCEL DMF# 7813 7814 7815 7816 7817 7818 7819 7820 7821 7822 7823 7824 7825 7826 7827 I 7828 7829 A 7830 7831 7832 I 7833 7834 7835 7836 7837 7838 I 7839 I 7840 7841 7842 I 7843 7844 7845 7846 7847 7848 A A I A I I II III II II I II 12/19/1988 1/23/1989 12/30/1988 12/29/1988 12/29/1988 12/28/1988 I I II II II 12/22/1988 12/19/1988 12/19/1988 DYNAMIT NOBEL AKTIENGESELLESCHAFT PENINSULA LABS I 12/22/1988 I I I I I II II I II II II 12/20/1988 12/15/1988 12/15/1988 12/20/1988 12/20/1988 12/22/1988 I I II III I 12/12/1988 12/14/1988 12/28/1988 I II II 12/8/1988 12/12/1988 STATUS Type SUBMIT DATE I I I I I A I A I A I I I I II II II II II IV II II II II III III I I II 12/20/1988 12/15/1988 12/19/1988 12/15/1988 12/15/1988 12/9/1988 12/15/1988 12/19/1988 12/15/1988 12/15/1988 12/13/1988 12/16/1988 11/21/1988 12/12/1988 12/13/1988 HOLDER SUMIKA FINE CHEMICALS CO LTD SANDOZ INDIA LTD CL PHARMA AG NIPPON PROTEIN CO INC ERREGIERRE SPA GATTESFOSSE SA PLAISTOW LTD CAMBREX PROFARMACO MILANO SRL IPCA LABORATORIES PVT LTD IPCA LABORATORIES LTD OWENS ILLINOIS INC UCB FILMS INC NATCO PHARMS PVT LTD SEPRACOR INC SUBJECT THIETHYLPERAZONE MALATE AS MFG. A THE GIFU PLANT IN JAPAN SULFAMETHOXAZOLE AS MFG. IN BOMBAY, INDIA CARBAMAZEPINE AS MFG. IN LINZ, AUSTRIA N-ACETYL-L-CYSTEINE AS MFG. IN KANAGAWA-KEN JAPAN BACLOFEN AS MFG. IN BERGAMO, ITALY LAUROGLYCOL AS MFG. IN SAINT-PRIEST, FRANCE XYLAZINE BASE AS MFG. IN CORK, IRELAND CINOXACIN MANUFACTURED IN MILAN, ITALY. ATENOLOL AS MFG. IN BOMBAY, INDIA PYRANTEL PAMOATE AS MFG. IN BOMBAY, INDIA THERMOPLASTIC CLOSURES AND PACKAGING MFG. IN CHATTANOOGA, TN CELLOPHANE PRODUCTS MFG. IN COVINGTON, IN AND TECUMSEH, KS FACILITY LOCATED IN ANDRHA PRADESH, INDIA PRODUCTION FACILITY IN VILLENEUVE LA GARENNE, FRANCE

4Q2012

VIS-INSTITUTO SCIENTIFICO DELLE VENEZIE CARBAMAZEPINE AS MFG. IN PADOVA, ITALY SPA NATL INST HLTH NCI NSC321803 PRODUCTOS QUIMICOS NATURALES SA DE CV PROQUINA SEPRACOR INC SPRUHVENTILE GMBH ZENECA PHARMACEUTICALS DIV ZENECA INC ZAMBON SPA GIVAUDAN CORPORATION GIVAUDAN CORPORATION IROPHARM LTD IROPHARM LTD SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP DYNAMIT NOBEL AKTIENGESELLESCHAFT D.H.A. PURE PRASTERONE AS MFG. IN IXTACZOQUITLAN, MEXICO DEAE-TRISACRYL M OR LS AS MFG. IN LA GARENNE, FRANCE AEROSOL VALVES AS MFG. IN GERMANY FACILITIES AND PERSONNEL LOCATED IN REIMS CEDEX, FRANCE LACTULOSE MANUFACTURED IN VICENZA, ITALY. PARSOL MCX AS MFG. IN CLIFTON, NJ FACILITIES, PERSONNEL AND GEN. PROC. IN CLIFTON, NEW JERSEY ORPHENADRINE HYDROCHLORIDE MFG. IN ARKLOW, WICKLOW, IRELAND ORPHENADRINE CITRATE AS MFG. IN ARKLOW, WICKLOW, IRELAND SUCRALFATE AS MFG. IN CONSHOHOCKEN, PA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LEVERKUSEN, GERMANY NITROGLYCERINE AS MFG. IN LEVERKUSEN,GERMANY HISTIDINYL-6-LYSINE-AMIDE MFG. IN BELMONT, CA

PROSINTEX INDUSTRIE CHIMICHE ITALIANE GUANABENZ ACETATE AS MFG. IN MILANO, ITALY SRL BASF PHARMA EVIONNAZ SA BENZONATATE AS MFG. IN EVIONNAZ, SWITZERLAND COMAR INC BACHEM FEINCHEMIKALIEN AG DIPHARMA FRANCIS SRL ROUSSEL-UCLAF EXPANSIA PLASTIC PACKAGING MATERIALS (ESUB) MANUFACTURED IN BUENA, NEW JERSEY. H-GLY-TYR-LYS-(DTPA)-0H. HCL MFG. IN BUBENDORF, SWITZERLAND NORTRIPTYLINE HCL AS MFG. IN MILANO, ITALY MFG. PROCESS AND CONTROL AT USIPHAR IN COMPIEGNE, FRANCE THIANAPHTEN CARBOXYLIC ACID AS MFG. IN ARAMON, FRANCE

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4Q2012EXCEL DMF# 7849 7850 7851 7852 A 7853 I 7854 7855 7856 7857 I 7858 7859 7860 7861 7862 I 7863 I 7864 7865 7866 7867 7868 I 7869 7870 7871 7872 7873 7874 7875 7876 7877 7878 7879 7880 7881 7882 7883 I 7884 A II 1/21/1989 I N I I I A I I I I I I I A II II III III II I IV I II II I II II 1/23/1989 1/20/1989 1/12/1989 1/12/1989 1/23/1989 1/12/1989 1/24/1989 1/10/1989 1/20/1989 1/20/1989 1/10/1989 1/24/1989 1/20/1989 II 1/5/1989 I I N I II II 1/16/1989 1/11/1989 II II 1/13/1989 1/9/1989 RECORDATI INDUSTRIA CHIMICA SPA BAYER AG NOT AN ASSIGNED NUMBER ORION CORP LTD BAXTER HEALTHCARE CORP BURDICK & JACKSON DIV REGIS TECHNOLOGIES INC NOT AN ASSIGNED NUMBER SYNTHELABO PHARMACIE DAITO KOEKI KK MONTELL CANADA INC KLOCKNER PENTAPLAST OF AMERICA INC OREX PHARMA PVT LTD SEITZ FILTER WERKE DS INDUSTRIE APS SCIENTIFIC PROTEIN LABORATORIES INC PENCO OF LYNDHURST INC PENCO OF LYNDHURST INC SCIENTIFIC PROTEIN LABORATORIES INC EGIS PHARMACEUTICALS PUBLIC LTD CO SHANGHAI NUMBER 12 PHARMACEUTICAL FACTORY NICOBRAND LTD 4-(2-CYCLOPROPYLMETHOXYETHYL) PHENOL MFG. IN MOURENX, FRANCE PINDOLOL AS MFG. IN TOYAMA-SHI, TOYAMA 939, JAPAN POLYPROPYLENE AS MFG. IN CORUNNA, ONTARIO, CANADA PACKAGING MATERIALS AS MFG. IN SOUTH HACKENSACK, NJ TRIMETHOPRIM AS MFG. IN DOMBIVLI (EAST) MAHARASHTRA, INDIA MICROFILTRATION MEMBRANE PLANT A BOSENHEIMER STR., GERMANY ESTASAN PR AS MFG. IN COPENHAGEN, DENMARK FACILITIES (BOVINE LUNG HEPARIN SODIUM) IN WAUNAKEE, WI CHLORPHENIRAMINE MALEATE AS MFG. IN LYNDHURST, NJ BROMPHENIRAMINE MALEATE AS MFG. IN LYNDHURST, NJ FACILITIES FOR THE MFG. OF HEPARIN CLACIUM IN WAUNAKEE, WI PROMETHAZINE HCL MANUFACTURED IN BUDAPEST, HUNGARY. FAVOXATE HCL AS MFG. IN ESPOO AND HANKO, FINLAND METHYL-T-BUTYL ETHER (MTBE) AS MFG. IN MUSKEGON, MI MELATONIN MANUFACTURED IN MORTON GROVE, ILLINOIS. FENTICONAZOLE NITRATE AS MFG. IN LATINA, ITALY ACEMETACIN AS MFG. IN WUPPERTAL 1 & LEVERKUSEN, GERMANY II 12/13/1988 I I I I I II II II III 1/9/1989 1/9/1989 1/13/1989 12/29/1988 1/16/1989 I I I I II II II 1/3/1989 12/30/1988 1/25/1989 9/23/1988 FOREST LABORATORIES INC PHARMECO LABS INC CHEMISCHE FABRIK WEYL GMBH INNER MONGOLIA PHARMACEUTICAL GENERAL CORP IROTEC LABORATORIES LTD IRISH FHER LABORATORIES SICOR SPA EASTMAN KODAK CO III 12/19/1988 LOPAREX INC STATUS Type SUBMIT DATE I I I II II III III 1/4/1989 12/9/1988 12/12/1988 12/19/1988 HOLDER KYOWA HAKKO KOGYO CO LTD NORDION INT INC JOHN L ARMITAGE AND CO LOPAREX LLC SUBJECT MINOCYCLINE HYDOCHLORIDE, SAKAI PLANT, OSAKA PREFECTURE JAPAN I-123 MYOPURE AS MFG. IN KANTA, ONTARIO, CANADA EH-22395-H PIGMENTED LINER AS MFG. IN BRIDGEPORT, CT

4Q2012

10127, S 42# SB SCK 6Z/000 MANUFACTURED IN IOWA CITY, IOWA AND BEDFORD PARK, ILLINOIS. 10699, S 5 MIL NT HDP 4N/000 MANUFACTURED IN IOWA CITY, IOWA AND BEDFORD, ILLINOIS. FACILITIES UTILIZED IN ST. LOUIS, MO ALTRETRAMINE AS MFG. IN SIMI VALLEY, CALIFORNIA METHAZOLAMIDE MFG. IN MANNHEIM, FEDERAL REPUBLIC OF GERMANY EPHEDRINE HYDROCHLORIDE, TONG LIAO CITY PLANT, INNER MONGOLIA FACILITIES UTILIZED IN LITTLE ISLAND, CORK, IRELAND AZAADINE MALEATE MFG. IN LITTLE ISLAND, CORK, IRELAND BETAMETHASONE BENZOATE AS MFG. IN MILAN, ITALY POTASSIUM TETRATOXALATE DIHYDRATE MFG. IN ROCHESTER, NY

FOLIENWALZWERK BRUEDER TECHNOLOGY LACQUERED ALUMINUM FOIL, IN OBERGRAFENDORF-MUHLOFEN, AUSTRIA AG LEK PHARMACEUTICAL & CHEMICAL WORKS CIMETIDINE MANUFACTURED IN MENGES, SLOVENIA

5-FLUOROURACIL MANUFACTURED IN SHANGHAI, PEOPLE'S REPUBLIC OF CHINA. NICOTINE (ESUB) AS MANUFACTURED IN CO. LONDONDERRY, NORTH IRELAND Page

220

4Q2012EXCEL DMF# 7885 7886 7887 7888 7889 I 7890 7891 7892 7893 7894 7895 I 7896 7897 7898 7899 7900 7901 A 7902 7903 7904 7905 7906 7907 7908 7909 7910 7911 7912 7913 7914 I 7915 7916 7917 7918 I 7919 7920 7921 N N N NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER I A I I II III I 2/3/1989 1/27/1989 2/1/1989 12/14/1988 I I I I I I I I I I I I IV IV II II II III II V I I III II I 2/1/1989 2/1/1989 2/1/1989 2/3/1989 2/2/1989 1/29/1989 1/26/1989 1/3/1989 2/8/1989 2/8/1989 2/8/1989 2/13/1989 1/31/1989 RHONE POULENC RHONE POULENC CHEMWERTH LISAC SA SUMIKA FINE CHEMICALS CO LTD SOLVAY & CIE SA FABBRICA ITALIANI SINTETICI SPA PHARMA HAMEIN GMBH BIOCHEMIC GESELLSCHAFT MBH BIOCHEMIC GESELLSCHAFT MBH GEORGIA PACKAGING INC RESOLUTION CHEMICALS LTD I I I I I II IV II II III II 1/28/1989 1/27/1989 1/30/1989 1/18/1989 1/20/1989 1/26/1989 WYCKOFF CHEMICAL CO INC ALBAMED INC HEINRICH MACK NACHF TCI AMERICA MEGAS MANUFACTURING INC CUNO INC A I I I I II II IV IV III I 1/25/1989 1/31/1989 1/27/1989 1/27/1989 1/25/1989 1/25/1989 MALLINCKRODT INC DYNAMIT NOBEL AKTIENGESELLESCHAFT ALBAMED INC SEPPIC DIV AIR LIQUIDE ARLON INC ALPHA PHARM PTY LTD STATUS Type SUBMIT DATE I I A I I I II II II 1/25/1989 1/25/1989 2/7/1989 1/30/1989 1/30/1989 HOLDER GLAXO WELLCOME INC GLAXO WELLCOME INC MAPRIMED SA BIOCHEMIC GESELLSCHAFT MBH MALLINCKRODT BAKER INC SUBJECT MFG. SITE FACILITIES UTILIZED IN SPEKE LIVERPOOL (UK) FACILITIES UTILIZED IN WARE HERTS, UNITED KINGDOM DILTIAZEM HCL AS MFG. IN BUENOS ARIES, ARGENTINA OXYTOCIN ACETATE LYOPHILIZED MANUFACTURED IN TYROL, AUSTRIA.

4Q2012

ABX AND CBX BONDED PHASE SILICA GELS MANUFACTURED IN PHILLIPSBURG, NEW JERSEY. NICOTINE (ESUB) AS MANUFACTURED IN CO. LONDONDERRY, NORTH IRELAND AZUD (CS-87) AS MFG. IN LEVERKUSEN, GERMANY MONTANIDE 103 AS MFG. IN CASTRES, FRANCE MONTANIDE 888 AS MFG. IN CASTRES, FRANCE SELF ADHESIVE FOAM PRODUCT AS MFG IN SANTA, CA 92704 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN QUEENSLAND, AUSTRALIA. PROTRIPTYLINE HYDROCHLORIDE MANUFACTURED IN SOUTH HAVEN, MICHIGAN. MONTANIDE 80 AS MFG. IN CASTRES, FRANCE ALEXAN 100MG/5ML VIAL(2% CYTARABINE SOLUTION) AS MFG. GERMANY METHAZOLAMIDE MANUFACTURED IN PORTLAND, OREGON. FACILITIES FOR PACKAGING IN CLEVELAND, OHIO NYLON MEMBRANE CARTRIDGE PRODUCTS MANUFACTURED IN MERIDEN, CONNECTICUT. IGEPAL CO-730 AS MFG. IN LINDEN, NJ ALKAMID CDO MANUFACTURED IN WINDER, GEORGIA. CARBAMAZEPINE AS MFG. BY NEPRA, INC. IN HARRIMAN, NEW YORK DIPYRIDAMOLEAS MFG. IN BARCELONA, SPAIN KETOPROFEN AS MFG. IN OSAKA, JAPAN HD-PE HOMOPOLYMER ELTEX B3002 AS MFG. IN SOLVAY LI, ITALY DILTIAZEM HYDROCHLORIDE AS MFG. IN VICENZA, ITALY STERILE PROCESSING FACILITY IN HAMELN, GERMANY STERILE PENICILLIN PRODUCTS FACILITY IN KUNDL, TYROL, AUSTRIA FACILITIES FOR ORAL PENICILLIN PRODUCTS IN KUNDL TYROL,AUSTRIA 4113-14 PRODUCTAS MFG. IN COLUMBUS, GA PRAZEPAM AS MFG. IN MIRFIELD, WEST YORKSHIRE, UK

SCHOTT PHARMACEUTICAL PACKAGING INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PHONIXVILLE, PENNSYLVANIA. SERONO LABORATORIES INC CELL CULTURE AND PROTEIN PURIFICATION FACILITY, IN RANDOLPH, MA ERIMOS TECHNOLOGIES LLC SUN CHEMICALS CORP LABORATOIRES MXM EXTRACTION OF M-NDGA BULK FORM IN EL PASO, TEXAS PRIMER COATING P76-1182 AS MFG. IN PHILADELPHIA, PA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ANTIBES, FRANCE.

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4Q2012EXCEL DMF# 7922 7923 7924 7925 I 7926 7927 7928 7929 7930 I 7931 I 7932 I 7933 7934 7935 I 7936 7937 7938 7939 7940 7941 7942 7943 7944 7945 7946 7947 7948 7949 7950 7951 7952 7953 7954 7955 I 7956 I 7957 I II 3/7/1989 CILAG CHEMIE AG I 3/1/1989 I A I A A I I I A I I I I I I I I I I II II II II IV III II II II II II II II II IV II II II II I 2/21/1989 2/16/1989 2/17/1989 2/8/1989 2/21/1989 3/3/1989 3/1/1989 3/1/1989 3/2/1989 3/1/1989 3/2/1989 2/24/1989 3/1/1989 3/1/1989 2/16/1989 3/6/1989 3/6/1989 3/7/1989 3/8/1989 2/23/1989 TAMAG BASEL AG KATWIJK CHEMIE BV TANABE SEIYAKU CO LTD LUPIN LTD PUROLITE CO TEICH AG IMAGENTS INC CELSUS LABORATORIES INC TANABE SEIYAKU CO LTD EGIS PHARMACEUTICALS CILAG AG XTTRIUM LABS INC CYGNUS INC LIQUID QUIMICA MEXICANA SA DE CV CELSUS LABORATORIES INC CELSUS LABORATORIES INC GUANGZHOU ZHUJIANG MEDICINE CO INC UNICORN ORGANICS LTD COVANCE PHARMACEUTICAL PACKAGING SERVICES INC ABBOTT LABORATORIES LTD SCHAFT ASTRA PHARMACEUTICAL PRODUCTS A I II II I 2/20/1989 2/28/1989 3/12/1989 III 2/28/1989 III 2/24/1989 I I I I I IV II III II 2/21/1989 2/21/1989 2/16/1989 2/14/1989 2/16/1989 SU HEUNG CAPSULE CO LTD SU HEUNG CAPSULE CO LTD WYCKOFF CHEMICAL CO INC INJECTRON CORP LABORATORIO CHIMICO INTERNATIONAL SPA FOLIENWALZWERK BRUEDER TECH AKTIENGESELLSCHAFT FOLIENWALZWERK BRUEDER TECH AKTIENGESELLSCHAFT COSMA SPA CADILA LABORATORIES PVT LTD BACHEM FINE CHEMICALS INC STATUS Type SUBMIT DATE I I I III II II I 2/7/1989 1/23/1989 2/7/1989 2/20/1989 HOLDER PMS CONSOLIDATED UNICHEM LABORATORIES LTD PENINSULA LABS LUPIN LABORATORIES LTD SUBJECT

4Q2012

COLORANTS AND FORMULATIONS MANUFACTURED IN FLORENCE, KENTUCKY. BUPRENORPHINE HYDROCHLORIDE MANUFACTURED IN BOMBAY, INDIA. LYSINYL-13-CYSTEINE AS MFG. IN BELMONT, CA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ANKLESHWAR (GUJARA) INDIA. MFG. SITE, FACILITIES AND PERSONNEL UTILIZED IN SEOUL, KOREA EMPTY GELATIN CAPSULES MANUFACTURED IN SEOUL, KOREA. MEFENAMIC ACID AS MFG. IN SOUTH HAVEN, MI PACKAGING MATERIALS AS MFG. IN PLAINFIELD, NJ M F 201 TARTRATE AS MFG. IN SEGRATE/MILAN, ITALY DOUBLE LAMINATED FOIL AS MFG. IN AUSTRIA SINGLE LAMINATED FOIL (FOIL, POLYETHYLENE) MFG. IN AUSTRIA ATENOLOL (ESUB) MANUFACTURED IN CISERANO, ITALY. NIFEDIPINE AS MFG. IN GUJARA, INDIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SAN DIEGO, CALIFORNIA. NICOTINE AS MFG. IN MENZIKEN, SWITZERLAND ETHOSUXIMIDE AS MFG. IN KATWIJK ANN ZEE IN THE NETHERLANDS TA-5707F AS MFG. IN OSAKA, JAPAN 7ADCA AS MFG. IN BOMBAY, INDIA POLACRILIN POTASSIUM AS MFG. IN MIDGLAMORGAN, WALES SINGLE LAMINATED FOIL (PAPER, FOIL) AS MFG. IN AUSTRIA TERBUTALINE SULPHATE AS MFG. IN SODERTALJE, SWEDEN RADIOCHEMICAL GALLIUM CHLORIDE GA-67 AS MFG. IN HOUSTON, TX HEPARIN SODIUM MANUFACTURED IN CINCINNATI, OHIO. PROTIRELIN AS MFG. IN OSAKA, JAPAN IMIPRAMINE HYDROCHLORIDE AS MFG. IN BUDAPEST, HUNGARY SUCCIMER AS MFG. IN SCHAFFHAUSEN, SWITZERLAND 4.0% CHLORHEXIDINE GLUCONATE SOLUTION 1101 MFG. IN CHICAGO IL FENTANYL TRANSDERMAL SYSTEM (FENTANYL TS) MFD IN REDWOOD CITY, CA CALCIUM CARBONATE MANUFACTURED IN NAUCALPAN DE JUAREZ, MEXICO. HEPARIN CALCIUM MANUFACTURED IN CINCINNATI, OHIO. LMW HEPARIN SODIUM AS MFG. IN CINCINNATI, OH MINOXIDIL AS MFG. IN DONG PU, GUANGZHOU, CHINA SORBITOL AS MFG. IN SECUNDERABAD, INDIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ALLENTOWN, PA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN QUEENBOURGH, KENT, UNITED KINGDOM. GUANABENZ ACETATE AS MFG. IN SCHAFFHAUSEN, SWITZERLAND Page

222

4Q2012EXCEL DMF# 7958 7959 7960 7961 7962 I 7963 I 7964 I 7965 7966 I 7967 7968 I 7969 7970 I 7971 7972 7973 7974 7975 7976 7977 7978 I 7979 7980 7981 7982 7983 7984 7985 7986 7987 7988 7989 7990 7991 7992 I I I A I I I I I I I I I I II II II II III II III II II II II II I II 3/17/1989 3/16/1989 2/14/1989 3/22/1989 3/7/1989 3/17/1989 3/7/1989 3/22/1989 3/29/1989 2/14/1989 3/29/1989 3/28/1989 3/23/1989 3/21/1989 BOEHRINGER MANNHEIM GMBH HEINRICH MACK NACHF ORGANON OSS FINE CHEMICALS CORP PTY LTD SPARTECH PLASTICS TAKEDA CHEMICAL INDUSTRIES LTD SPARTECH PLASTICS JOHNSON MATTHEY INC VULCAN CHEMICALS BACHEM FEINCHEMIKALIEN AG CADILA LABORATORIES PVT LTD ERREGIERRE SPA GLAXO WELLCOME INC CILAG AG I I I A I I A II IV II III II I IV I 3/8/1989 2/28/1989 3/16/1989 3/10/1989 1/17/1989 3/17/1989 2/14/1989 2/13/1989 I I II 3/16/1989 3/14/1989 I I II 3/8/1989 3/14/1989 I II II 3/13/1989 3/14/1989 TAMILNADU DADHA PHARMACEUTICAL RECKITT & COLMAN PRODUCTS LTD PHARMACEUTICAL DIV TAMILNADU DADHA PHARMACEUTICAL RECKITT & COLMAN PRODUCTS LTD PHARMACEUTICAL DIV PHARMPAC CO INC DIV OF CARDIO PHARM RECKITT & COLMAN PRODUCTS LTD PHARMACEUTICAL DIV RECORDATI CORP AIR PRODUCTS AND CHEMICALS INC ISP SETCO INC SANOFI SYNTHELABO INC. GENPHARM INC NOF CORP LIPOSOME CO INC I 3/13/1989 TAMILNADU DADHA PHARMACEUTICAL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF CISPLATIN IN MADRAS, INDIA. CISPLATIN AS MFG. IN MADRAS, INDIA RX77368 ORAL SOLUTION (FREEZE DRIED) MFG. SITE AND FACILITIES UTILIZED IN MADRAS, INDIA RX77368 INTRAVENOUS INJECTION (FREEZE DRIED) MFG. SITE AND FACILITIES UTILIZED IN BAAVIA, NY RX77368 AS MFG. IN N. HUMBERSIDE, UK AND LANCASTER, UK DANAZOL AS MFG. IN MADRAS, INDIA OCTADECAFLUORODECAHYDRONAPHTHALENE (PERFLUORODECALIN) 4-(METHYLTHIO) BENZOIC ACID MANUFACTURED IN COLUMBUS, OHIO. PACKAGING MATERIALS AS MFG. IN CRANBURY, NJ TICLOPIDINE HYDROCHLORIDE AS MFG. IN EVIONNAZ/VS, SWITZERLAND FACILITIES LOCATED IN ETOBICKE, ONTARIO, CANADA DIMYRISTOYL PHOSPHATIDYL CHOLINE AS MFG. IN HYOGO, JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HYOGO, JAPAN. NITROFURANTOIN MACROCRYSTALLINE AS MFG. IN MANNHEIM, FRG BROXURIDINE AS MFG. IN BAVARIA, FRG ORGABOLIN TABLETS 2 MG. AS MFG. IN OSS, THE NETHERLANDS METHAZOLAMIDE MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA. THERMOPLASTIC SHEET TYPE H-S-H AS MFG. IN PORTAGE, WI PYRIDOXINE HYDROCHLORIDE AS MFG. IN HIKARI-CITY, JAPAN THERMOPLASTIC SHEET TYPE PP-E-PP MANUFACTURED IN PORTAGE, WI PENTAMIDINE GLUCONATE AS MFG. IN WEST DEPTFORD, NJ SODIUM CHLORITE MANUFACTURED IN STAMFORD, CONNECTICUT. HUMAN ALPHA CALCITONIN GENE RELATED PEPIDE, SWITZERLAND GLYBURIDE BP'88 (GLIBENCLAMIDE) AS MFG. IN GUJARA, INDIA ACEBUTOLOL HYDROCHLORIDE MANUFACTURED IN BERGAMO, ITALY. MFG. FACILITIES LOCATED IN JURONG, SINGAPORE MOLINDONE HYDROCHLORIDE AS MFG. IN SCHAFFHAUSEN, SWITZERLAND IV 2/27/1989 JOGUE CORP STATUS Type SUBMIT DATE I I I I III II I II I 2/22/1989 3/21/1989 3/9/1989 3/7/1989 3/8/1989 HOLDER APEX PLASTIC INC EASTMAN KODAK CO GENERICS LTD OMNICHEM NV (PRB) UNICORN ORGANICS LTD SUBJECT PACKAGING MATERIALS MANUFACTURED IN BROOKFIELD, MO 2-AMINO-N-(1-METHYL-1,2-DIPHENULETHYL) ACETAMIDE MONOHCL FACILITY UTILIZED IN POTTERS BAR, HERTS, ENGLAND PENTAMIDINE ISETHIONATE AS MFG. IN WETTERN, BELGIUM

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SECUNDERABAD, INDIA. VARIOUS FLAVOR FORMULATIONS MANUFACTURED IN DETROIT, MICHIGAN AND INDIA.

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4Q2012EXCEL DMF# 7993 I 7994 7995 7996 I 7997 7998 7999 8000 A 8001 I 8002 8003 8004 8005 8006 8007 8008 8009 8010 8011 8012 8013 8014 8015 8016 8017 8018 8019 8020 8021 8022 8023 8024 8025 8026 8027 8028 8029 A A I I I I I I I I I I I I I I I I I I A I I A I I I A II II II III I I IV II II II III II I II I II II II II II II III II III I III II II 3/23/1989 4/5/1989 4/4/1989 3/31/1989 4/4/1989 4/6/1989 4/1/1989 4/6/1989 4/3/1989 4/17/1989 4/5/1989 4/13/1989 3/20/1989 3/2/1989 4/8/1989 4/8/1989 4/24/1989 3/31/1989 4/10/1989 4/20/1989 4/4/1989 4/6/1989 4/12/1989 4/7/1989 4/3/1989 5/1/1989 4/24/1989 4/19/1989 II 3/20/1989 VIS-INSTITUTO SCIENTIFICO DELLE VENEZIE BENZTHIAZIDE AS MFG. IN PADOVA, ITALY SPA BASF PHARMA EVIONNAZ SA CHLOROPROCAINE HYDROCHLORIDE MFG. IN EVIONNAZ/VS, SWITZERLAND CELSUS LABORATORIES INC EISAI CO LTD KANE INTL CORP LYPHOMED INC DHL LABORATORIES INC WILD FLAVORS INC NATL INST HLTH NCI RHONE-POULENC MORTON THIOKOL INC A FRADAGRADA AND A PETTENATI SRL UCB BIOPRODUCTS SA ETHYPHARM FREEDOM CHEMICAL DIAMALT GMBH NAGASE AMERIKA CORP YUKI GOSEI KOGYO CO LTD LABORATOIRES DELAGRANGE MALLINCKRODT CHEMICAL INC CHEMIE LINZ GES MBH APOTEX PHARMACHEM INC ROCHE PRODUCTS INC PREJECT PRODUCTS SA MERCK KGAA ARIZONA CHEMICAL CO DELCOR LABORATORIES INC COILLIR MANUFACTURING INC WOCKHARDT LTD VERTELLUS HEALTH AND SPECIALTY PRODUCTS LLC AMMONIUM HEPARIN AS MFG. IN CINCINNATI, OH EPERISONE AS MFG. IN TOKYO, JAPAN STYSOLAC AW AS MFG. IN HETERENE CHEMICAL CO. IN NEW JERSEY MFG. FACILITIES LOCATED IN CANOVANAS, PUERTO RICO FACILITIES UTILIZED IN UNION, SC MASKING FLAVOR #076932 AS MFG. IN CINCINNATI, OH PENTAMIDINE ISETHIONATE AS MFG. IN PHARM-ECO, SIMI VALLEY, CA ETHIONAMIDE SUPPOSITORIES, 500 MG, THERAPLIX SA, PARIS, FR MAGNESIUM HYDROXIDE AS MFG. IN MANISTEE, MI PHARMACEUTICAL RUBBER CLOSURES AS MFG. IN MILAN, ITALY SALCATONIN ACETATE AS MFG. IN BRAINE-L'ALLEUD, BELGIUM FACILITIES, PERSONNEL AND PROCEDURES LOCATED IN HOUDAN, FRANCE ATENOLOL AS MFG. IN RAUBLING, FEDERAL REPUBLIC OF GERMANY FACILITIES LOCATED IN TOKYO, JAPAN 2,3,-DIDEOXYINOSINE AS MFG. IN TOKYO, JAPAN LAD 2691 AS MFG. IN ARPAJON, FRANCE POTASSIUM CHLORIDE AS MFG. IN ST. LOUIS, MISSOURI L-NORADRENALINE BITARATE MONOHYDRATE AS MFG. IN LINZ, AUSTRIA CIMETIDINE AS MFG. IN TOLUCA, ESTADO DE MEXICO, MEXICO FLUOROLACTAM AS MFG. IN MANATI, PUERTO RICO PREJECT PREFILLED SYRINGES AS MFG. IN GLAND, SWITZERLAND BISOPROLOL FUMARATE 2:1 AS MFG. BY VON GLENCK & CIE AQUAIC 6025 AS MFG. BY ARIZONA CHEM AND HI-TEK POLYMERS PACKAGING FACILITY LOCATED IN E. STROUDSBURG, PA MATERIALS MFG. BY AUTEX FIBERS AND COURTAEUDIS FIBERS CAPTOPRIL AS MFG. IN DIST. BHARUCH GUJARAT STATE, INDIA CETYLPYRIDINIUM CHLORIDE AS MFG. IN ZEELAND, MI I I I IV II I II 3/28/1989 3/28/1989 3/23/1989 3/31/1989 I A II II II 3/13/1989 3/22/1989 4/4/1989 STATUS Type SUBMIT DATE IV 3/22/1989 HOLDER SPECIALTY PRODUCTS INTERNATIONAL, INC. DINAMITE DIPHARMA SPA KANEKA CORP SHANGHAI NO 6 PHARMACEUTICAL FACTORY UNGERER AND CO SIBEFAT SPA MARTEC PHARMACEUTICALS INC SUBJECT CO-CRYSTALLIZED MANNITOL/SORBITOL MFG. IN MEW CASTLE, DE PROTRIPTYLINE HCL AS MFG. IN MILANO, ITALY

4Q2012

N-[1(S)-ETHOXYCARBONYL-3-PHENYLPROPYL]-L-ALANYL-N-CARBOXY ANHYDRIDE TRETINOIN AS MFG. IN SHANGHAI, PRC MOUTHWASH FLAVOR #16390 IN LINCOLN PARK, NEW JERSEY KETOPROFEN AS MFG. IN TRIBIANO (MILANO) ITALY LABORATORY, PACKAGING, LABELING FACILITIES IN KANSAS CITY, MO

VERTELLUS PERFORMANCE MATERIALS INC ACETYLTRIETHYL CITRATE MANUFACTURED IN GREENSBORO, NORTH CAROLINA.

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4Q2012EXCEL DMF# 8030 8031 8032 8033 8034 I 8035 8036 8037 8038 8039 8040 8041 8042 8043 8044 8045 8046 8047 8048 8049 8050 I 8051 8052 8053 8054 8055 I 8056 8057 8058 8059 8060 8061 8062 A 8063 8064 I 8065 I II 4/28/1989 SUMIKA FINE CHEMICALS CO LTD CYCLOBENZAPRINE HYDROCHLORIDE MFG. IN GIFU PREFECTURE, JAPAN I II II 4/28/1989 5/5/1989 JANSSEN PHARMACEUTICA NV MALLINCKRODT INC CLAZURIL - R 62690 AS MANUFACTURED IN BEERSE AND GEEL, BELGIUM A I I I A I II II III IV II I II 5/4/1989 5/11/1989 3/21/1989 4/25/1989 5/6/1989 4/24/1989 5/6/1989 I I I I II II II II II 5/1/1989 3/26/1989 5/5/1989 4/28/1989 5/4/1989 SIPSY PLAISTOW LTD EURAND AMERICA INC JANSSEN PHARMACEUTICA NV KRKA PHARMACEUTICAL & CHEMICAL WORKS SUMITOMO CHEMICAL CO LTD VALEAS SPA PHE PHARMA ELASTOMERE GMBH CO KG SIMETRY COMPANY CIPLA LTD ANAQUEST INC CIPLA LTD I I I N I A A I I I I I I I I II II II II II II II II II III III III 4/26/1989 4/18/1989 4/14/1989 4/21/1989 4/21/1989 4/26/1989 4/27/1989 5/1/1989 4/25/1989 4/25/1989 4/25/1989 4/25/1989 II II II 4/27/1989 4/28/1989 4/26/1989 IMAGENTS INC ROUSSEL-UCLAF SEPRACOR INC NOT AN ASSIGNED NUMBER SEPRACOR INC ZACH SYSTEM LONZA AG ORGAMOL SA NORDIC SYNTHESIS AB IAF BIOCHEM INTERNATIONAL INC REGIS CHEM CO IMAGENTS INC IROPHARM LTD RELEASE INTL MOORE & MUNGER MARKETING INC LOPAREX INC SP-TRISACRYL M OR LS AS MFG. IN VILLENEUVE LA GARENNE, FRANCE PAROXETINE STAGE 2 DL-AMINO ALCOHOL MFG. IN AVRILLE, FRANCE NIACIN (NICOTINIC ACID) AS MFG. IN VISP, SWITZERLAND MEBEVERINE HYDROCHLORIDE AS MFG. IN EVIONNAZ, SWITZERLAND NIFEDIPINE AS MFG. IN KARLSKOGA, SWEDEN DESMOPRESSIN AS MFG. IN MONTREAL, QUEBEC, CANADA AMINOGUANIDINE HYDROCHLORIDE AS MFG. IN MORTON GROVE, IL TUNGSTEN W-178 RADIOCHEMICAL AS MFG. IN HOUSTON, TEXAS CLOMIPRAMINE HYDROCHLORIDE AS MFG. IN ARKLOW, IRELAND 8 POINT SBS POLY SLIK -IOWA CITY, IOWA AND BEDFORD PARK, ILL TEMPORARY ADHESIVE MADE FROM A BLEND OF WAXES RADIOCHEMICAL THALLOUS CHLORIDE TL-201 AS MFG. IN HOUSTON, TX BECLOMETHASONE DIPROPIONATE USP AS MFG. IN VERTOLAYE, FRANCE HA-ULTROGEL AS MFG. IN VILLENEUVE LA GARENNE, FRANCE STATUS Type SUBMIT DATE I I I I II I I IV II 4/24/1989 4/20/1989 4/28/1989 4/27/1989 4/25/1989 HOLDER BIOSOURCE TECHNOLOGIES INC GYNOPHARMA INC DAIICHI SEIYAKU CO LTD ADVANCED POLYMER SYSTEMS DINAMITE DIPHARMA SPA SUBJECT MELANIN AS MFG. IN VACAVILLE AND MORGAN HILL, CA FACILITIES, METHODS AND CONTROLS IN SOMERVILLE, NJ

4Q2012

PRODUCTION TECHNOLOGY RESEARCH LABS., EDOGAWA-KU, TOKYO, JAPAN MMA/EGDMA MICROSPONGES AS MFG. IN LAFAYETTE, LOUISIANA FENBUFEN MANUFACTURED IN THE BARANZATE DI BOLLATE (MILAN), ITALY FACILITIES

11504 S 94# BL KFT L/HP 4D/000 MANUFACTURED IN BEDFORD PARK AND WEST CHICAGO, ILLINOIS, IOWA CITY, IOWA, AND EDEN, NORTH CAROLINA. LOPERAMIDE HYDROCHLORIDE AS MFG. IN AVRILLE, FRANCE N,N-,BIS(PYRIDOXAL-5-PHOSPHATE) ETHYLENE-DIAMINE-N,N-DIACETIC ASPIRIN EC-2 (MICROENCAPSULATED) AS MFG. IN VANDALIA, OH CLAZURIL TABLETS 2.5 MG (R 62690) AS MFG. IN BEERSE, BELGIUM PIROXICAM AS MFG. IN NOVO MESTO, YUGOSLAVIA SC-26480 (INTERMEDIATE) AS MANUFACTURED IN GIFU PREFECTURE, JAPAN BRONCOVALEAS INHALER (ALBUTEROL INHALER) MFG. IN MILAN, ITALY RUBBER FORMULATIONS AS MFG. IN SUMMERAH, FRG HYDROPHOBIC CARRIER FOR CONTROLLED RELEASE DOSAGE FORMS ALPRAZOLAM (ESUB) AS MANUFACTURED IN BANGALORE, INDIA FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN GUAYAMA, PR TERBUTALINE SULFATE (ESUB) AS MANUFACTURED IN BOMBAY AND BANGALORE, INDIA

SODIUM IODIDE I-123 (ESUB) AS MANUFACTURED IN MARYLAND HEIGHTS, MO FACILITY

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4Q2012EXCEL DMF# 8066 I 8067 8068 8069 8070 8071 I 8072 8073 8074 8075 8076 8077 8078 8079 8080 8081 8082 8083 8084 8085 I 8086 8087 8088 8089 8090 8091 8092 8093 8094 8095 8096 8097 8098 I 8099 8100 8101 8102 8103 I I I I I II II II III III 6/13/1989 4/27/1989 6/8/1989 5/31/1989 5/31/1989 I I I N I I I I A I I I III II II II III II II II V 5/24/1989 6/1/1989 6/1/1989 6/7/1989 6/1/1989 6/7/1989 4/25/1989 6/8/1989 5/30/1989 I I II 5/16/1989 5/8/1989 5/19/1989 ABBOTT LABORATORIES LTD KM LEE LABORATORIES DOW CORNING CORP NOT AN ASSIGNED NUMBER AIR PRODUCTS & CHEMICALS INC CAMBREX PROFARMACO MILANO SRL ROCHE PALO ALTO LLC DIOSYNTH BV NIPPON FOIL MANUFACTURING CO LTD SIBEFAT SPA CESQUISA SA HOECHST MARION ROUSSEL SA BRISTOL MYERS PRODUCTS DIV BRISTOL MYERS CO ZENECA INC RESEARCH BIOCHMICALS INC CILAG AG SCHUBERT SEALS A/S SCHUBERT SEALS A/S FLEXCRYL 1614 EMULSION AS MFG. IN SOUTH BRUNSWICK, NJ AMOXAPINE AS MFG. IN MILAN, ITALY TICLOPIDINE HCL- BOULDER, CO, SPRINGFIELD, MO, EVIONNAZ,SWITZ DESMOPRESSIN AS MFG. IN OSS, HOLLAND PACKAGING MATERIALS AS MFG. IN KUSATSU-CITY, SHIGA, JAPAN MICONAZOLE NITRATE AS MFG. IN MILAN, ITALY CLOBETASOL PROPIONATE AS MFG. IN PEROGORDO, SEGOVIA, SPAIN VINORELBINE DITARTRATE AS MFG. IN ROMAINVILLE, FRANCE STERILE PROCESSING FACILITY IN JAPAN SDM 70 AS MFG. BY ALAS POWER CO. IN TAMAQUA, PA (HIPDM) AS MFG. IN NATICK, MA CYCLOBENZAPRINE HCL AS MFG. IN SCHAFFHAUSEN, SWITZERLAND 7.2 MM PLUNGER AS MFG. IN HORSENS, DENMARK RUBBER SHEET LAMINATE FOR DISCS MFG. IN HORSENS, DENMARK I I I I I I I I I I I I A IV I II II II II II IV I II IV III III I 8/17/1988 5/15/1989 5/11/1989 5/18/1989 4/18/1989 5/15/1989 5/17/1989 5/30/1989 5/17/1989 5/11/1989 5/19/1989 5/24/1989 5/23/1989 5/26/1989 I I I A III IV I II II 5/9/1989 5/9/1989 5/26/1989 5/9/1989 5/10/1989 GRAHAM PACKAGING COMPANY L.P. TAKASAGO INTERNATIONAL CORP SAFEPHARM LABORATORIES LTD PHARMAZELL GMBH ABBOTT LABS CHEM AND AGRICULTURAL PRODS DIV UNILEVER UNITED STATES INC ERBA BIOCHIMICA SPA MALLINCKRODT CHEMICAL INC SEPRACOR INC FARMABOIS GANTAX NV PHARMACEUTICA PENICK CORP AVANTI POLAR LIPIDS INC WHEATON APPLICATOR CO WACKER CHEMIE GMBH B BRAUN MEDICAL INC AIR PRODUCTS & CHEMICALS INC ABBOTT BIOLOGICALS BV TRANS CONTAINER CORP CONTAINER/CLOSURE SYSTEMS AS MFG IN NORTH KANSAS CITY MO TAK 80128 NATURAL ORANGE FLAVOR AS MFG. IN TETERBORO, NJ FACILITIES LOCATED IN SHARDLOW, ENGLAND 5-AMINOSALICYLIC ACID AS MFG. IN RAUBLING, FRG BRADYKININ ACETATE NPC-567 AS MFG. IN NORTH CHICAGO, IL DURKEE 07 EXCIPIENT AS MFG. IN JOLIET, IL FACILITIES LOCATED IN MILANO, ITALY FENTANYL ALKALOID AS MFG. IN ST. LOUIS, MO S-(+)- IBUPROFEN AS MFG. IN MARLBOROUGH, MA BECLOMETHASONE DIPROPIONATE MFG. IN GROPELLO CAIROLI, ITALY PANCRUONIUM BROMIDE AS MFG. IN BRUSSEL, BELGIUM MEPERIDINE HYDROCHLORIDE AS MFG. IN NEWARK, NEW JERSEY 1-STEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (PTDCHO-MONO180) FACILITIES LOCATED IN MILLVILLE, NJ PHTALIMIDOACETONE AS MFG. IN BURGHAUSEN, FED. REP. OF GERMANY STERILIZATION, SOLUTION PRODUCTS AS MFG. IN IRVINE, CA FLEXCRYL 1653 EMULSION AS MFG. IN SOUTH BRUNSWICK, NJ PREFILLED BD READYFILL SYRINGE AS MFG. IN OLST, THE NETHERLANDS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN UPLAND, CALIFORNIA. FACILITIES LOCATED IN QUEENBOROUGH, KENT, UK MFG. SITE AND FACILITIES LOCATED IN SANTA FE SPRINGS, CA BIO-RELEASE SILICONE RELEASE COATING SYSTEM, HEMLOCK, MI STATUS Type SUBMIT DATE II 5/16/1989 HOLDER SUBJECT FUJISAWA PHARMACEUTICAL COMANY LTD FK366 ALDOSE REDUCTASE INHIBITOR AS MFG. IN OSAKA, JAPAN

4Q2012

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4Q2012EXCEL DMF# 8104 8105 8106 8107 8108 8109 8110 8111 I 8112 8113 I 8114 8115 8116 8117 8118 8119 8120 8121 8122 8123 8124 A 8125 8126 I 8127 8128 I 8129 8130 8131 A 8132 8133 8134 A 8135 8136 8137 8138 I I I I II II II I 7/12/1989 7/12/1989 7/12/1989 6/30/1989 BIOCHEMIC GESELLSCHAFT MBH BIOCHEMIC GESELLSCHAFT MBH GEMA SA SYNTEX SA I I II II II 7/13/1989 7/14/1989 7/14/1989 A I II I II 7/10/1989 6/30/1989 7/10/1989 CAMBREX PROFARMACO MILANO SRL AID PACK INC MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC EASTMAN KODAK CO NOVO NORDISK AS BAYER SCHERING PHARMA AG I II I 7/5/1989 7/10/1989 DAITO KOEKI KK VALPHARMA S A I I I 7/3/1989 7/3/1989 NPBI B V NPBI B V FACILITIESLOCATED IN EMMEN, THE NETHERLANDS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERALOPERATING PROCEDURES IN EMMER-COMPASCUUM, THE NETHERLANDS CARBIDOPA AS MFG, BY DAITO KOOEKI KK IN TOYAMA, JAPAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN REPUBLIC SAN MARINO. METAPROTERENOL SULFATE AS MFG. IN MILAN, ITALY FACILITIES LOCATED IN GLOUCESTER, MASSACHUSETTS NASAL NICOTINE SOLUTION (NNS) AS MFG. IN HELSINGBORG, SWEDEN A-(2-AMINO-3-P-BROMOBENZOYLPHENYL) ACETIC ACID SODIUM SALT SUBTILISIN A AS MFG. IN BAGSVATERD, DENMARK A I A I I I I I I I IV II II II II II II II I I III 6/28/1989 6/20/1989 6/26/1989 6/26/1989 7/15/1989 6/28/1989 7/7/1989 6/13/1989 7/6/1989 7/6/1989 7/19/1989 JM HUBER CORP HEUMANN SANOFI AVENTIS DEUTSCHLAND GMBH LUSOCHIMICA S P A DIOSYNTH BV OCCIDENTAL CHEM CORP CIPLA LTD HEUMANN TEKKOTE CORP BOREALIS AB BOREALIS AG A II III 6/20/1989 6/22/1989 NV ORGANON BAXTER HEALTHCARE CORP STATUS Type SUBMIT DATE I I I I I I I III I II II II II II II 6/2/1989 6/16/1989 6/12/1989 6/15/1989 6/15/1989 6/15/1989 6/23/1989 6/26/1989 HOLDER GERRESHEIMER BUNDE GMBH HAYDEN MANUFACTURING CO INC BOEHRINGER MANNHEIM GMBH CUNO INC CUNO INC BAYER AG UNILEVER UNITED STATES INC CUNO INC SUBJECT STAKED NEEDLE DISPOSABLE SYRINGE MFG. IN BUNDE/WESTFALEN FRG FACILITIES FORHAYDEN MOLDING LTD. IN BRANTFOR, ONTARIO, CANADA CATALASE THERAPEUTIC GRADE AS MFG. IN PENZBERG, FRG ZETA PLUS LA MEDIA AND CARTRIDGES IN STAFFORD SPRINGS, CT ZETA PLUS SA MEDIA AND CARTRIDGES IN STAFFORD SPRINGS, CT AMPICILLIN SODIUM STERILE MFG. IN WUPPERTAL, GERMANY DURKOTE CALCIUM CARBONATE 1551-95 (P), JOLIET & CHICHAGO, IL

4Q2012

ZETA PLUS CA MEDIA AND CARTRIDGES MANUFACTURED IN STAFFORD SPRINGS, CONNECTICUT. RIMEXOLONE MICRO AS MFG. IN OSS THE NETHERLANDS PRODUCTION OF TERMINALLY STERILIZED PARENTERAL SOLUTIONS IN SEAL/FILL/SEAL CONTAINERS IN ROUND LAKE, IL AND CLEVELAND,MS. AMORPHOUS PRECIPITATED SILICON DIOXIDE MFG. IN MD AND TN CYCLOBENZAPRINE-HCL AS MFG. IN NUREMBERG, FRG LEFLUNOMIDE (HWA 486) AS MFG. IN WIESBADEN, GERMANY TERBUTALINE SULPHATE AS MFG. IN MILAN, ITALY HUMAN MENOPAUSAL GONADOTROPHIN NATURAL - OSS, THE NETHERLANDS ETHYLENE DICHLORIDE AS MFG. IN DEER PARK, TEXAS PROPANOLOL HCL AS MFG. IN BOMBAY, INDIA DICLOFENAC SODIUM AS MFG. IN FEUCHT, GERMANY FACILITIES LOCATED IN MOONACHIE, NJ FACILITIES LOCATED IN STENUNGSUND, SWEDEN BORMED LE6601-PH AND BORMED LE6607-PH AS MANUFACTURED IN PORVOO, FINLAND

CIPROFLOXACIN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN WUPPERTAL, GERMANY TDA AS MFG. IN KUNDL, TYROL, AUSTRIA TET-ACA AS MFG. IN KUNDL, TYROL, AUSTRIA CEFAZOLIN AS MFG. IN STA. PERPETUA DE MOGUDA, SPAIN FACILITIES LOCATED IN MEXICO CITY, MEXICO

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4Q2012EXCEL DMF# 8139 I 8140 8141 I 8142 8143 8144 8145 8146 A 8147 8148 I 8149 8150 8151 I 8152 8153 8154 8155 8156 8157 8158 8159 8160 I 8161 8162 8163 8164 8165 8166 8167 8168 8169 A 8170 8171 8172 8173 8174 I A I I I III II II IV III 8/9/1989 8/9/1989 8/11/1989 8/17/1989 8/18/1989 HAZEN PAPER CO BASF PHARMA EVIONNAZ SA PHARM ECO LABORATORIES INC IMAJE INK JET PRINTING CO DOW DERMATOLOGICS INC I I I A I I I I II II II II III I II I III 8/2/1989 7/27/1989 8/2/1989 8/2/1989 8/10/1989 8/15/1989 8/15/1989 7/25/1989 8/7/1989 I I I I I I I I II I III III III III III III II 8/1/1989 7/27/1989 7/31/1989 7/31/1989 7/31/1989 7/31/1989 7/31/1989 7/31/1989 8/8/1989 A I III IV II 7/11/1989 7/26/1989 7/25/1989 STYROLUTION GMBH RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA SOGO PHARMACEUTICAL CO LTD CIMA LABORATORIES INC SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S ABBOTT LABS CHEM AND AGRICULTURAL PRODS DIV DELMAR CHEMICALS INC SEPRACOR INC CAMBREX PROFARMACO MILANO SRL CAMBREX PROFARMACO MILANO SRL PHARMASCIENCES INC BRISTOL MYERS CO INTERNATIONAL DIV RHONE POULENC IRONWOOD INDUSTRIES LOPAREX LLC I II III 7/20/1989 7/31/1989 SIGMA F AND D DIV LTD EXXONMOBIL CHEMICAL CO I I I I II II II IV III 7/26/1989 7/26/1989 7/26/1989 7/26/1989 7/19/1989 NEWPORT PHARMACEUTICALS (IRELAND) SELOC AG WARNER LAMBERT CO INNOPHOS INC FRIEDRICH SANNER GMBH CO KG A II V 7/7/1989 7/25/1989 IWAKI SEIYAKU CO LTD BRISTOL MYERS SQUIBB COMPANY STATUS Type SUBMIT DATE I 7/7/1989 HOLDER AKROSIL SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MENASHA, WISCONSIN. PHENYLEPHRINE HCL AS MDF. IN SHIZUOKA, JAPAN

4Q2012

FACILITIES FOR PARENTERAL MANUFACTURING (BUILDING 115) LOCATED IN NEW BRUNSWICK, NJ METOPROLOL TARTRATE AS MFG. IN DUBLIN, IRELAND NORTRIPTYLINE HCL AS MFG. BY SIFA LTD., CLARE, IRELAND MECLOFENAMATE SODIUM AS MFG. IN HOLLAND, MI DIBASIC CALCIUM PHOSPHATE, ANHYDROUS GRANULAR, CHICAGO HTS IL PACKAGING MATERIALS MANUFACTURED IN AUERBACH, FEDERAL REPUBLIC OF GERMANY N,N-DIMETHYLTRYPTAMINE AS MFG. IN ST. LOUIS, MO SANTOPRENE THERMOPLASTIC RUBBER GRADE 171-55-W199 AS MFG. IN PENSACOLA FLAND WADSWORTH OH LURAN 358 N AS MFG. IN LUDWIGSHAFEN, GERMANY GALLOPAMIL HCL AS MFG. IN LATINA, ITALY SULFADIMETHOXINE MFG. AT THE FUKUOKA, JAPAN PLANT FACILITIES LOCATED IN MINNEAPOLIS, MN RUBBER COMPOUND 6404 AS MFG. IN HORSENS, DENMARK RUBBER COMPOUND 41003 AS MFG. IN HORSENS, DENMARK RUBBER COMPOUND 42038 AS MFG. IN HORSENS, DENMARK RUBBER COMPOUND 42022 AS MFG. IN HORSENS, DENMARK RUBBER COMPOUND 41002, HORSENS, DENMARK PTFE FILM AS MFG. IN HORSENS, DENMARK GADOLINIUM DIETHYLENETRIAMINEPENTAACETIC ACID, N. CHICAGO, IL AMIODARONE HCL AS MFG. IN LASALLE, QUEBEC, CANADA DEAE SPHERODEX M/LS AS MFG. IN VILLENEUVE-LA-GARENNE, FRANCE DIFLUNISAL AS MFG. IN MILAN, ITALY CROMOLYN SODIUM MANUFACTURED IN MILAN, ITALY. HIMEDICS DISPENSER AS MFG. IN HOLLYWOOD, FL FACILITIES LOCATED IN MAYAGUEZ, PUERTO RICO LINDANE AS MFG. IN LE PONT DE CLAIX, FRANCE FACILITIES LOCATED IN LIBERTYVILLE, IL 10694, S 5 MIL CL PET 4N/000 MANUFACTURED IN IOWA CITY, IOWA AND BEDFORD PARK, ILLINOIS. DRUG PACK H-130 AS MFG. IN HOLYOKE, MA CINCHOCAINE BASE AND HCL AS MFG. IN EVIONNAZ, SWITZERLAND PENTAMIDINE ISETHIONATE AS MFG. IN SIMI VALLEY, CA ED-1112-H2 BLUE INK AS MFG. IN SMYRNA, GA VOID

HENRY H OTTENS MANUFACTURING CO INC NATURAL & ARTIFICIAL CHERRY MINT #5095-A MFG. IN PHILA., PA

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4Q2012EXCEL DMF# 8175 8176 8177 8178 8179 8180 I 8181 8182 8183 8184 8185 8186 8187 8188 8189 8190 8191 8192 8193 8194 I 8195 A 8196 8197 8198 8199 I 8200 I 8201 8202 I 8203 I 8204 8205 8206 8207 8208 8209 8210 I A I I I I I II II II I II III II 8/11/1989 9/6/1989 9/6/1989 9/8/1989 9/15/1989 9/15/1989 9/18/1989 A QUIMICA SINTETICA SA QUIMICA SINTETICA SA UNISYN TECHNOLOGIES CORP RALLIS INDIA LTD ASAHI CHEM INDUSTRY CO LTD SUMITOMO CHEMICAL CO LTD I 9/7/1989 CHEMI SPA I III I 5/3/1989 9/1/1989 II 9/8/1989 DSM PHARMA CHEMICALS SOUTH HAVEN INC CLEARPLASS CONTAINER INC YUKI GOSEI KOGYO CO LTD I I I II II I I 9/5/1989 9/5/1989 9/5/1989 9/11/1989 II 9/8/1989 I I I I I I I I I I A A I III IV II II II IV II II II I II II I I 8/24/1989 8/22/1989 8/24/1989 8/28/1989 8/25/1989 8/18/1989 8/9/1989 8/25/1989 8/28/1989 8/31/1989 8/10/1989 8/28/1989 9/7/1989 9/8/1989 STATUS Type SUBMIT DATE I I I A I II II II II I II 7/19/1989 8/15/1989 8/30/1989 8/15/1989 8/18/1989 8/21/1989 HOLDER PHARMECO LABORATORIES INC ABBOTT LABORATORIES DELMAR CHEMICALS INC BAYER SCHERING PHARMA AG LUMELITE PLASTICS NATL INST HLTH CONTRACEPTIVE DEV BRANCH EI DUPONT DE NEMOURS AND CO AVATAR CORP A NANTONG PHARMACEUTICAL FACTORY SUMIKA FINE CHEMICALS CO LTD A FINE CHEMICALS CORPORATION CREATIVE BIOMOLECULES EGIS PHARMACEUTICALS PUBLIC LTD CO GRUPPO LEPETIT SPA KOEI CHEMICAL CO LTD CHENG FONG CHEMICAL CO LTD HIMEDICS INC SUBJECT DIPIVEFRIN HCL AS MFG. IN SIMI VALLEY, CA PENTAMIDINE ISETHIONATE AS MFG. IN NORTH CHICAGO, IL FAMOTIDINE AS MFG. IN LASALLE, QUEBEC, CANADA IOPROMIDE AS MFG. IN BERGKAMEN, FRG FACILITIES AND PERSONNEL LOCATED IN PAWLING, NY ANTIDE, CONTRACTED MANUFACTURER SALK INSTITUTE, SAN DIEGO, CA TEFLON FEP FLUROCARBON RESINS, TYPES 100, 140, 160 LIGHT MINERAL OIL NF AS MFG. IN HICKORY HILLS, IL POTASSIUM NITRATE AS MFG. IN WARREN, NJ PIROXICAM AS MFG. IN NANTONG, JIANGSU PROVINCE, CHINA METHOTREXATE AS MFG. IN ANPACHINGUN AND OSAKA, JAPAN FLAVOR POTENTIATOR #3096-E AS MFG. IN PHILADELPHIA, PA GUANABENZ ACETATE AS MFG. IN EPPINDUST, SOUTH AFRICA EPIDERMAL GROWTH FACTOR-51 AS MFG. IN HOPKINTON, MA CARBIDOPA AS MFG. IN BUDAPEST, HUNGARY FACILITIES LOCATED IN GARESSIO (CUNEO) ITALY PYRMETHYLALCOHOL AS MFG. KIN OSAKA, JAPAN DICLOFENAC SODIUM AS MFG. IN TA YUAN HISANG, TAIWAN, CHINA R&D PLANT 1 LOCATED IN HOLLYWOOD, FL

4Q2012

CG SMITH CHEMICALS DIV CG SMITH SUGAR FACILITIES LOCATED IN DURBAN, SOUTH AFRICA LTD RELAX LTD LACTULOSE CONCENTRATE MANUFACTURED BY NATAL CANE IN DURBAN, SOUTH AFRICA. MEIJI SEIKA KAISHA LTD PIRARUBICIN BASE AS MFG. IN KANAGAWA, JAPAN MEIJI SEIKA KAISHA LTD MEIJI SEIKA KAISHA LTD SEITZ FILTER WERKE PIRARUBICIN HCL FOR INJECTION AS MFG. IN KANAGAWA, JAPAN ODAWARA PLANT LOCATED IN KANAGAWA, JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BAD KREUZNACH, FRG. KETOPROFEN AS MFG. IN SOUTH HAVEN, MI CONTAINERS MANUFACTURED IN SHEFFIELD, ALABAMA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF 2-DEOXYCYTIDINE HYDROCHLORIDE IN TOKYO, JAPAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PARICA (FROSINONE)ITALY. CHLORTHALIDONE AS MFG. IN LOUGHBOROUGH, LEICES, UK MICONAZOLE NITRATE AS MFG. IN MADRID, SPAIN LOPERAMIDE HCL AS MFG. IN MADRID, SPAIN FACILITIES LOCATED IN TUSTIN, CA CROMOLYN SODIUM AS MFG. IN ANKLESHWAR, GUJARA, INDIA BARRIALON UB-6 AS MFG. IN TOKYO, JAPAN SM-8668 AS MFG. IN OSAKA, JAPAN

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4Q2012EXCEL DMF# 8211 8212 8213 I 8214 I 8215 I 8216 8217 I 8218 8219 8220 8221 8222 8223 8224 8225 8226 8227 8228 8229 I 8230 8231 8232 8233 8234 8235 8236 8237 I 8238 8239 8240 8241 8242 8243 8244 I 8245 8246 I A I III 10/10/1989 10/16/1989 I I I A I A II II I II I II I 10/5/1989 10/5/1989 10/4/1989 10/6/1989 9/12/1989 10/11/1989 10/12/1989 I I I I A I I II II II V II II I I 9/25/1989 10/3/1989 9/29/1989 9/29/1989 10/1/1989 10/5/1989 9/29/1989 10/3/1989 AVATAR CORP MEDICHEM SA DISCOVERY THERAPEUTICS INC DISCOVERY THERAPEUTICS INC SIFAVITOR SRL IAF BIOCHEM INTERNATIONAL INC KNOLL PHARMACEUTICAL CO KANEGAFUCHI CHEMICAL INDUSTRY CO LTD ERREGIERRE SPA ROUSSEL-UCLAF IVERS LEE LTD ASH STEVENS INC FINE GRINDING CORP NYCOMED GMBH A A A A I I I A I I I II II III II II III I II II I II III 8/18/1989 9/7/1989 9/18/1989 9/21/1989 9/20/1989 9/25/1989 9/26/1989 9/21/1989 9/29/1989 9/26/1989 9/26/1989 9/18/1989 JANSSEN PHARMACEUTICA NV FDC LTD LOPAREX LLC ALBEMARLE CORP TOMITA PHARM CO LTD BETTS MEXICO SA DE CV NP IND ROCHE DIAGNOSTICS GMBH SUMITOMO CHEMICAL CO LTD HAMPSHIRE CHEMICAL CORP. ICI COLOURS & FINE CHEMS ADVANCED ELASTOMER SYSTEMS I II I 9/19/1989 9/19/1989 II 9/20/1989 RHONE POULENC INSTITUTE DE BIOPHARMACIE GANES CHEMICALS INC NORTHVIEW LABS INC I 9/19/1989 SMITH & NEPHEW PHARMACEUTICALS LTD STATUS Type SUBMIT DATE I I II II I 9/1/1989 9/19/1989 9/19/1989 HOLDER EURAND AMERICA INC SMITH AND NEPHEW RES LTD SMITH AND NEPHEW RES LTD SUBJECT

4Q2012

MICROENCAPSULATED SULFAMETHOXAZOLE MANUFACTURED IN VANDALIA, OHIO. APRACLONIDINE HCL AS MFG. IN HARLOW & ROMFORD, ESSEX, UK MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HARLOW, ESSEX, UNITED KINGDOM. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ROMFORD, ESSEX, UNITED KINGDOM UREA-CALCIUM ACETYLSALICYLATE, VITRY SUR SEINE CEDEX, FRANCE NORTRIPTYLINE CARBAMATE MFG. IN CARLSTADT OR PENNSVILLE, NJ MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NORTHBROOK, ILLINOIS. DICLAZURIL AS MFG. IN BEERSE AND GEEL, BELGIUM FLURBIPROFEN AS MFG. IN ROHA, MAHARASHTRA STATE, INDIA 11117, S 72# BL KFT L/L 4D/000 MANUFACTURED IN IOWA CITY, IOWA TETRACAINE HCL AS MFG. IN SOUTH HAVEN, MI ALUMINUM HYDROXIDE GEL MANUFACTURED IN TOKUSHIMA, JAPAN. PACKAGING MATERIALS MFG. IN FLORENCE, KY FACILITIES LOCATED IN ST. LOUIS, MO ADENOSINE DEAMINASE THERAPEUTIC GRADE MFG. IN PENZBERG, FRG TIMOLOL MALEATE AS MFG. IN ANPACHI-GUM, GIFU AND OSAKA, JAPAN FACILITIES LOCATED IN DEER PARK, TEXAS THIOTEPA AS MFG. IN MANCHESTER, ENGLAND TREFSIN THERMOPLASTIC RUBBER AS MFG. IN WADSWORTH, OHIO AND PENSACOLA, FLORIDA. PROPYLENE GLYCOL AS MFG. IN HICKORY HILLS, ILLINOIS PIROXICAM AS MFG. IN GERONA, SPAIN N-0923 AS MFG. IN IOWA CITY, IOWA PHARMACOLOGY & TOXICOLOGY DATA ON N-0923 CROMOLYN SODIUM AS MFG. IN MILAN, ITALY CALCITONIN AS MFG. IN MONTREAL, QUEBEC, CANADA FACILITIES LOCATED IN NOTTINGHAM, ENGLAND FACILITIES LOCATED IN TAKASAGO CITY, HYOGO PREFECTURE, JAPAN TERFENADINE MANUFACTURED IN SAN PAOLO D'ARGON BERGAMO, ITALY. NORETHINDRONE AS MFG. IN VERTOLAYE, FRANCE FACILITIES LOCATED IN BRAMPTON, ONTARIO, CANADA FLUDARABINE PHOSPHATE AS MFG. IN DETROIT, MICHIGAN FACILITIES LOCATED IN CONSHOHOCKEN, PENNSYLVANIA PANTOPRAZOLE SODIUM SESQUIHYDRATE

BYK GULDEN LOMBERG CHEMISCHE FABRIK FACILITIES LOCATED IN SINGEN AND KONSTANZ, GERMANY GMBH GREENWICH PHARMACEUTICALS INC FACILITIES LOCATED IN HORSHAM, PENNSYLVANIA MITSUBISHI PLASTICS INC VINYFOIL RIGID PVC CALENDERED FILM AS MFG. IN TOKYO, JAPAN

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4Q2012EXCEL DMF# 8247 I 8248 8249 8250 8251 8252 8253 8254 8255 8256 I 8257 8258 8259 A 8260 I 8261 8262 8263 8264 8265 8266 8267 8268 I 8269 8270 8271 8272 8273 8274 8275 8276 8277 8278 8279 8280 8281 8282 8283 I I I I I I A I I I I I I I I II II III II I I III III II II II II II II II 10/27/1989 10/31/1989 10/2/1989 10/24/1989 10/27/1989 10/27/1989 10/26/1989 10/23/1989 10/31/1989 10/3/1989 11/2/1989 11/2/1989 11/2/1989 10/24/1989 11/6/1989 TIANJIN PHARMACEUTICAL PLANT TOKYO KASEI KOGYO CO LTD CALIGEN FOAM LTD CHEMI SPA EISAI CO LTD EISAI CO LTD KEY INTERNATIONAL INC SCHUBERT SEALS A/S SUMIKA FINE CHEMICALS CO LTD FREEDOM CHEMICAL DIAMALT GMBH ABBOTT PHARMS INC AVATAR CORP MALLINCKRODT BAKER INC AMINO GMBH PENINSULA LABS I I A I I I I II II II II II II I I 10/12/1989 10/12/1989 10/27/1989 11/22/1989 10/27/1989 10/17/1989 10/25/1989 10/31/1989 ARCHIMICA SPA ARCHIMICA SPA ANDRULIS PHARMACEUTICALS CORP SIPSY SNC AMERSHAM CORP RHONE-POULENC SANTE GRAIN PROCESSING CORP TOKYO KASEI KOGYO CO LTD III 10/16/1989 A I IV II II 10/12/1989 10/20/1989 10/17/1989 LIPOID KG WYCKOFF CHEMICAL CO INC VERTELLUS AGRICULTURE NUTRITION SPECIALTIES LLC ANCHOR HOCKING PACKAGING A I I A I I I I III II IV III II II I II I 10/12/1989 10/12/1989 10/11/1989 10/9/1989 10/3/1989 10/19/1989 10/20/1989 10/17/1989 10/17/1989 STATUS Type SUBMIT DATE II 10/17/1989 HOLDER DSM PHARMA CHEMICALS NETHERLANDS BV CUSTOM BOTTLE INC SMITH KLINE CONSUMER PRODUCTS GRAFCO SEPRACOR INC BACHEM FINE CHEMICALS INC BAYER AG PROFARMACO SRL EASTMAN CHEMICAL CO SUBJECT 3-T-BUTYLAMINO-1,2-PROPANEDIOL AS MFG. IN VENLO, NETHERLANDS EXTRUSION BLOWN PLASTIC BOTTLES AS MFG. IN NAUGATUCK, CT. BANDING OF PSEUDOEPHEDRINE HCL AND CHLORPHENIRAMINE MALEATE PET PLASTIC CONTAINERS AS MFG. IN JONESBORO, GEORGIA QMA SPHEROSIL M/LS AS MFG. IN VILLENEUVE-LA-GARENNE, FRANCE GLUCAGON (1-29), HUMAN HCL SALT - TORRANCE AND SAN DIEGO, CA. FACILITY AND OPERATING PROCEDURES IN DORMAGEN, GERMANY ETHYL ESTER 3-(2-CHLORO-4,5-DIFLUOROPHENYL)-3-OXO PROPIONIC MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN ROCHESTER, NEW YORK. LIPOID PG 18:0/18:0-L-A-DISTEAROYLPHOSPHATIDYLGLYCEROL-NA PROBUCOL AS MFG. IN SOUTH HAVEN, MICHIGAN NIACIN AS MFG. IN ANTWERPEN, BELGIUM

4Q2012

HENRY H OTTENS MANUFACTURING CO INC NATURAL/ARTIFICIAL CHERRY MINT FLAVOR #5073A - PHILA., PA.

CONTINUOUS THREAD METAL CLOSURES MANUFACTURED IN GLASSBORO, NEW JERSEY. 2-CHLORO-4.5-DIFLUOROPHENYL-B-KETOESTER (SOL.) - VARESE,ITALY 2-CHLORO-4.5-DIFLUOROPHENYL-B-KETOESTER -VARESE, ITALY THALIDOMIDE AS MFG. IN BELTSVILLE, MARYLAND HYDROCORTISONE-17-BUTYRATE AS MFG. IN AVRILLE, FRANCE SODIUM IOTHALAMATE I-125 INJECTION AS MFG. IN AMERSHAM, UK NICERGOLINE AS MFG. IN VITRY SUR SEINE, CEDEX, FRANCE FACILITY FOR WATER LOCK(R) SUPERABSORBENT POLYMERS IN IOWA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FUKAYA, JAPAN. HYDROCORTISONE AS MFG. IN TIANJIN, CHINA 2,7-DIFLUORO-5-METHOXYSPIRO(9H-FLUORENE-9,4'-IMIDAZOLIDINE POLYESTER POLYURETHANE FOAM 5100A MFG. IN LANCASHIRE, UK OXIRACETAM AS MFG. IN FORSINONE, ITALY FACILITY IN GIFU-KEN, JAPAN FOR THE MFG. OF E3810 DRUG PRODUCT FACILITY IN IBARAKI-KEN, JAPAN MFG. OF E3810 DRUG SUBSTANCE POLYETHYLENE FILM AS MFG. IN ENGLISHTOWN, NEW JERSEY RUBBER COMPOUND 6374B2 AS MFG. IN HORSENS, DENMARK MESORIDAZINE BESYLATE AS MFG. IN GIFU, ANPACHIGUN, JAPAN 6-PROPYL-2-THIOURACIL AS MFG. IN MUNICH, GERMANY FENTANYL CITRATE AS MFG. IN CHICAGO, ILLINOIS WHITE MINERAL OIL AS MFG. IN HICKORY HILLS, ILLINOIS SODIUM FLUORIDE AS MFG. IN PHILLIPSBURG, NEW JERSEY L-TRYPTOPHAN AS MFG. IN HELMSTEDT, GERMANY HISTIDINYL-31-GLYCINE AS MFG. IN BELMONT, CALIFORNIA

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4Q2012EXCEL DMF# 8284 8285 8286 8287 8288 A 8289 I 8290 I 8291 8292 I 8293 I 8294 8295 8296 8297 8298 8299 8300 8301 8302 8303 8304 8305 8306 8307 8308 8309 8310 8311 8312 8313 8314 8315 8316 8317 8318 8319 8320 I I C I A A I I I A A I I I A I I I A I I I I I I I I II II II II II III III I I III II II I II II II II II II I II I II II II II III 11/16/1989 11/10/1989 11/14/1989 11/13/1989 11/17/1989 11/27/1989 10/1/1989 11/16/1989 11/22/1989 11/3/1989 11/24/1989 11/17/1989 12/4/1989 12/4/1989 11/1/1989 11/10/1989 11/27/1989 11/27/1989 11/27/1989 11/27/1989 12/1/1989 12/7/1989 12/7/1989 12/1/1989 12/8/1989 12/11/1989 12/7/1989 CHEMAPOL LTD CHEMAPOL LTD TEVA PHARMACEUTICAL INDUSTRIES LTD RECORDATI INDUSTRIA CHIMICA SPA TEVA WOMENS HEALTH INC TICONA LLC ROSSENDALE COMBINING CO LTD GRIFFITH MICRO SCIENCE INC SOUTHERN RESEARCH INSTITUTE HOFFMANN NEOPAC AG BASF PHARMA EVIONNAZ SA SEPRACOR INC SANOFI CHIMIE BIOCHEMICAL FACTORY NANJING UNIV LEO PHARMA AS BOEHRINGER KNOLL LTD WHATMAN ORGAMOL SA LEO PHARMA AS LEO PHARMACEUTICAL PRODUCTS LTD LANZ LABORATORIES XYROFIN AG XYROFIN AG FINE ORGANICS LTD FERMENTECH LIMITED MITSUBISHI CHEMICAL CORP (FILE IS RETIRED) V 11/21/1989 DR MADAUS GMBH A II II 11/24/1989 11/16/1989 MEDICHEM SA GUANABENZ ACETATE AS MFG. IN GERONA, SPAIN LEK PHARMACEUTICAL & CHEMICAL WORKS AURANOFIN AS MFG. IN LJUBLJANA, YUGOSLAVIA II 11/15/1989 I 11/17/1989 STATUS Type SUBMIT DATE I I I I I II II III II 11/10/1989 11/15/1989 11/14/1989 11/17/1989 11/17/1989 HOLDER THERATECH INC MEDICHEM SA ZAMBON SPA SPA SAFTA SUBJECT FACILITY LOCATED IN SALT LAKE CITY, UTAH KETOPROFEN AS MFG. IN GERONA, SPAIN PROBUCOL USP AS MFG. IN VIA DOVARO, ITALY POLYESTER, ALUMINUM FOIL , POLYETHYLENE AS MFG. IN ITALY

4Q2012

UNION QUIMICO FARMACEUTICA SA UQUIFA RANITIDINE HCL AS MFG..IN BARCELONA SPAIN SA SIMIREX INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MT. LAUREL, NEW JERSEY. GUANGDONG PHARMACEUTICAL FACTORY SULFADIAZINE AND SULFADIAZINE SODIUM AS MFG. IN CHINA

NON-PRODUCT SPECIFIC DOCUMENTATION FOR STERILIZATION PROCESS VALIDATION APPLICATIONS FOR HUMAN AND VETERINARY DRUG PRODUCTS SULFAMETHAZINE AS MFG. IN USTI AND LABEM, CZECHOSLOVAKIA SULFANILAMIDE AS MFG. IN USTI AND LABEM, CZECHOSLOVAKIA CARBIDOPA AS MFG. BY ASSIA LTD. IN PETAH-TIQVA ISRAEL MEBEVERINE HYDROCHLORIDE AS MFG. IN MILANO, ITALY COPPER T MODEL TCU 380A INTRAUTERINE CONTRACEPTIVE -NEW YORK RITEFLEX POLYESTER ELASTOMER AS MFG. IN SHELBY, N. CAROLINA POLYETHYLENE FILM FOAM LAMINATE AS MFG. IN LANCS, ENGLAND ETO STERILIZATION PROCESS IN WILLOWBROOK, ILLINOIS FACILITY LOCATED IN BIRMINGHAM, ALABAMA LAMINATE COLLAPSIBLE TUBING AS MFG. IN OBERDIESSBACH, SWITZ. FELBAMATE (W-554) AS MFG. IN EVIONNAZ, SWITZERLAND SP-SPHERODEX M/LS AS MFG. IN VILLENEUVE-LA-GARENNE, FRANCE FACILITY LOCATED IN SISTERON, FRANCE CHINESE CRUDE HMG AS MFG. IN NANJING, CHINA CALCIPOTRIOL DRUG SUBSTANCE AS MFG. IN BALLERUP, DENMARK PROPRANOLOL HYDROCHLORIDE AS MFG. IN THANE, INDIA WHAMAN DE52 (DIETHYLAMINOETHYL CELLULOSE) AS MFG-KENT, UK PROPAFENONE HYDROCHLORIDE AS MFG. IN EVIONNAZ, SWITZERLAND CALCIPOTRIOL OINTMENT AS MFG. IN BALLERUP, DENMARK FACILITIES AND OPERATING PROCEDURES IN BALLERUP, DENMARK LOPERAMIDE HYDROCHLORIDE AS MFG. IN MAHARASHTRA, INDIA FACILITIES AND OPERATING PROCEDURES AS MFG. IN KOTKA, FINLAND XYLITOL AS MFG. IN KOTKA, FINLAND N,N-DIMETHYLAMINOTHIOACETAMIDE HYDROCHLORIDE PROTEIN A AS MFG. IN EDINBURGH, SCOTLAND MCI-196 DRUG SUBSTANCE AS MFG. IN JAPAN ZELTUBE AS MFG. IN ZELL/MOSEL GERMANY

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4Q2012EXCEL DMF# 8321 8322 8323 I 8324 8325 8326 8327 8328 8329 8330 8331 8332 8333 I 8334 8335 8336 8337 8338 8339 8340 8341 8342 8343 I 8344 8345 I 8346 8347 8348 8349 I 8350 I 8351 8352 8353 8354 8355 8356 I I I A I A III II II III II III 12/15/1989 11/19/1989 12/26/1989 12/14/1989 12/29/1989 12/20/1989 III 12/31/1989 I I I III II II II 12/26/1989 12/15/1989 11/10/1989 12/29/1989 I III II 11/30/1989 12/14/1989 I I A I I I I A I II II II I II II III V II II 12/19/1989 12/9/1989 12/9/1989 12/18/1989 12/18/1989 12/19/1989 12/7/1989 12/14/1989 12/21/1989 12/21/1989 I A N I I I I I I IV II II II IV I I 12/6/1989 12/13/1989 12/12/1989 12/11/1989 12/12/1989 12/19/1989 12/20/1989 II IV 12/18/1989 11/30/1989 POLI INDUSTRIA CHIMA SPA AKZO NOBEL CHEMICALS BV NOT AN ASSIGNED NUMBER SELTZER CHEMS INC MACFARLAN SMITH LTD ROUSSEL-UCLAF CUNO INC INTERNATIONAL SPECIALTY PRODUCTS IOLAB PHARMACEUTICALS MERCK SHARP & DOHME LABS CHIBRET RESEARCH CTR ACF CHEMIEFARMA NV FARMABOIS FARMABIOS S P A COURTAULDS CHEMS COURTAULDS CHEMS PENNISULA LABORATORIES INC SOLVAY & CIE SA IONISOS NORDION INT INC SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT BESPAK PLC 1ST SOUTHWEST PHARMACEUTICAL FACTORY SEITZ FILTER WERKE NEPERA INC NEORX INC DL-LEUCINE FCC III AS MFG. IN CARLSBAD, CALIFORNIA MORPHINE SULFATE AS MFG. IN EDINBURGH, SCOTLAND TRIAMCINOLONE HEXACETONIDE AS MFG. IN VERTOLAYE, FRANCE ZETA PLUS ZA MEDIA AND CARTRIDGES AS MFG. IN MERIDEN, CT GANEX V-216 AS MFG. IN LINDEN, NJ AND SPARTANBURG, SC STATUS Type SUBMIT DATE I I II I I 12/5/1989 11/27/1989 6/11/1985 HOLDER CUNO INC LEO PHARMACEUTICAL PRODUCTS LTD BRISTOL MYERS CO INTERNATIONAL DIV SUBJECT

4Q2012

ZETAFFINITY UNCOUPLED MEDIA MANUFACTURED IN MERIDEN, CONNECTICUT. FACILITIES AND OPERATING PROCEDURES AS MFG. IN DUBLIN, IRELAND FACILITIES LOCATED IN BARCELONETA, PUERTO RICO - PREVIOUSLY AN ANTIBIOTIC FILE PENTOXIFYLLINE AS MFG. IN MILAN, ITALY AKUCELL AF2781 AS MFG. IN ARNHEM, THE NETHERLANDS

FACILITIES AND OPERATING PROCEDURES IN SAN GERMAN, PUERTO RICO - BUILDING 2 FACILITIES AND OPERATING PROCEDURES IN CLERMONT-FERRAND,FRANCE SULFADIAZINE SODIUM AS MFG. IN MAARSSEN, HOLLAND HALCINONIDE AS MFG. IN PAVIA, ITALY CLOBETHASOL-17-PROPIONATE AS MFG. IN PAVIA, ITALY FACILITIES AND OPERATING PROCEDURES IN MANCHESTER, ENGLAND N,N-DIAMETHYLAMINOTHIOACETAMIDE HCL - MANCHESTER, ENGLAND DYNORPHIN A 1-10 AMIDE AS MFG. IN BELMONT, CALIFORNIA (HDPE) ELTEX B 5920 UM AS MFG. IN SARRALBE, FRANCE FACILITY AND PROCEDURES FOR GAMMA RAY STERILIZATION IN DAGNEUX FRANCE YTTRIUM 90 AS REVIALLED IN ONTARIO, CANADA PHYSOSTIGMINE SALICYLATE AS MFG. IN BASLE, SWITZERLAND TIMPILO VIAL SUB-ASSEMBLY IN NORFOLK, UK CIMETIDINE AS MFG. IN XINAN, CHINA SUPRADISC (R) DEPTH FILTER MODULES, BAD KREUZNACH, FRG ESTROPIPATE AS MFG. IN HARRIMAN, NY RHENIUM RE 186 AS MFG. IN SEATTLE, WA AND COLUMBIA, MO

PLIVA PHARMACEUTICAL CHEMICAL FOOD & CHLORHEXIDINE BASE AS MFG. IN ZAGREB, CROATIA COSMETIC INDUSTRY ADVANCED MONOBLOC INC EIANLAKK IA-1001A MANUFACTURED IN HERMITAGE, PENNSYLVANIA AND ONTARIO, CANADA. AMPACET CORP 11147 CAMEL WHITE PEMB AS MFG. IN MOUNT VERNON, NY NOBEL CHEMS SPA SUMIKA FINE CHEMICALS CO LTD AMPACET CORP BACHEM FEINCHEMIKALIEN AG KETOPROFEN AS MFG. IN MILAN, ITALY PIROXICAM AS MFG. IN OSAKA AND GIFU PREFECTURE, JAPAN 11078 WHITE PEMB AS MFG. IN MOUNT VERNON, NY THYMORALIN AS MFG. IN BUBENDORF, SWITZERLAND

CELANESE EVA PERFORMANCE POLYMERS AT 1070 AND 1070C AS MFG. IN ONTARIO AND ALBERTA, CANADA

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4Q2012EXCEL DMF# 8357 8358 8359 I 8360 8361 8362 8363 I 8364 8365 8366 I 8367 8368 8369 8370 8371 8372 8373 8374 8375 8376 8377 8378 8379 8380 8381 8382 8383 8384 8385 8386 8387 I 8388 I 8389 8390 8391 8392 8393 I I I I I II II II I II 1/18/1990 1/19/1990 1/25/1990 1/25/1990 1/15/1990 II 1/22/1990 I I I I A I I I I I A I A I A I I I I I I II II II II II II I II III II II II II II II II IV IV I II 12/22/1989 12/19/1989 1/11/1990 1/11/1990 12/25/1989 11/22/1989 1/11/1990 1/15/1990 1/16/1990 1/26/1990 1/15/1990 1/12/1990 1/19/1990 1/22/1990 11/23/1989 1/24/1990 1/22/1990 1/23/1990 1/23/1990 1/18/1990 1/23/1990 LABORATOIRE PEROUSE STERILISATION VIATRIS GMBH AND COMPANY KG QUIMICA SINTETICA SA KNOLL PHARMA CHEMICALS TAISHO PHARMACEUTICAL CO LTD AZIENDE CHIMICHE RIUNITE KYOWA HAKKO KOGYO CO LTD MEDISOL LABORATORIES INC DAINIPPON PHARMACEUTICAL CO LTD FERRO CORP ROCHE DIAGNOSTICS GMBH SALK INST BIOLOGICAL STUDIES EVONIK TECHNOCHEMIE GMBH MALLINCKRODT INC SIFAVITOR SRL MARION MERRELL DOW INC STOLLE RES & DEV CORP SEPPIC DIV AIR LIQUIDE SEPPIC DIV AIR LIQUIDE CLINICAL PACKAGING SERVICES INC SHANGHAI NO 2 PHARMACEUTICAL FACTORY DSM PHARMA CHEMICALS SOUTH HAVEN INC PFANSTIEHL LABORATORIES INC THERAKOS INC PAREKH CHEMICALS ITALIA SPA PAREKH CHEMICALS ITALIA SPA ORGAMOL SA A I II II I 12/29/1989 3/28/1989 12/21/1989 I I I I II III II 12/28/1989 12/27/1989 11/13/1989 12/18/1989 WYETH AYERST RESEARCH SQUIBB MARK DIV ER SQUIBB & SONS INC IRONWOOD INDUSTRIES STATUS Type SUBMIT DATE I I II I I 8/21/1989 12/22/1989 12/28/1989 HOLDER DIOSYNTH BV MERRELL DOW PHARMS CANADA INC TROPONWERKE GMBH CO KG SUBJECT MIRTAZAPINE AS MFG. IN OSS, THE NETHERLANDS FACILITIES AND OPERATING PROCEDURES IN ONTARIO, CANADA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. FACILITIES AND OPERATING PROCEDURES IN QUEBEC, CANADA HYDROXYUREA LYOPHILIZED POWDER AS MFG. IN NEW BRUNSWICK, NJ JAYCAPS AS MFG. IN LIBERTYVILLE, ILLINOIS

4Q2012

PLIVA PHARMACEUTICAL CHEMICAL FOOD & CHLORHEXIDINE GLUCONATE SOLUTION AS MFG. IN ZAGREB, CROATIA COSMETIC INDUSTRY PHARMACOSMOS AS IRON DEXTRAN POWDER (ESUB) AS MANUFACTURED IN VIBY SJ., DENMARK HYBRITECH INC RISDON PHARMA YTTRIUM-90 CHLORIDE AS MFG. IN SAN DIEGO, CALIFORNIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DIEPPE, FRANCE. FACILITIES LOCATED IN RANTIGNY, FRANCE AZELASTINE HCL AS MFG. IN VARIOUS LOCATIONS IN GERMANY TERFENADINE AS MFG. IN MADRID, SPAIN FLOSEQUINAN AS MFG. IN NEWCASTLE-UPON-TYNE AND NOTTINGHAM, UK HYDROCORTISONE BUTEPRATE AS MFG. IN OHMIYA-SHI, JAPAN ETOPERIDONE HYDROCHLORIDE AS MFG. IN APRILIA, ITALY SODIUM HYALURONATE AS MFG. IN THE HOFU PLANT FACILITIES LOCATED IN EAST HANOVER, NJ A-4140 AS MFG. IN OSAKA, JAPAN THERMOPLASTIC COMPOUNDS AS MFG IN HOUSTON, TEXAS PROPYLTHIOURACIL, AS MFG. IN MANNHEIM, GERMANY ANITIDE AS MFG. IN SAN DIEGO, CA. CHLORHEXIDINE GLUCONATE AS MFG. IN HANAU, GERMANY SODIUM PERRHENATE RE 186 INJECTION, MARYLAND HEIGHTS, MO PROTRIPTYLINE HYDROCHLORIDE AS MFG. IN MILAN, ITALY SUDAFED 12-HOUR CAPSULES AS MFG. IN KANSAS CITY, MO 90 DAY PROGESTERONE AS MFG. IN CINCINNATI, OH SEPIFILM 752 AS MFG. IN CASTRES, FRANCE SEPIFILM 003 AS MFG. IN CASTRES, FRANCE FACILITIES AND OPERATING PROCEDURES IN WATERBURY, CT SULFATHIAZOLE AS MFG. IN SHANGHAI, CHINA NORTRIPTYLINE HYDROCHLORIDE MANUFACTURED IN SOUTH HAVEN, MICHIGAN. AURANOFIN AS MFG. IN WAUKEGAN, IL UVADEX (METHOXSALEN), STERILE SOLUTION, NUTLEY, NJ CEFADROXIL AS MFG IN BORGO SAN GIOVANNI (MI) ITALIA FACILITIES IN BORGO SAN GIOVANNI, MILAN, ITALY ESERINE BASE AND SALICYLATE AS MFG. IN EVIONNAZ, SWITZERLAND

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4Q2012EXCEL DMF# 8394 8395 8396 8397 8398 8399 8400 8401 8402 8403 8404 8405 8406 I 8407 I 8408 8409 8410 A 8411 8412 8413 8414 8415 8416 I 8417 8418 8419 I 8420 8421 8422 8423 8424 8425 8426 8427 8428 8429 I I I A I I I I I I IV II III II II II II II I II 1/31/1990 2/6/1990 2/1/1990 2/2/1990 1/1/1990 2/6/1990 2/1/1990 1/31/1990 2/6/1990 1/26/1990 PACO RESEARCH CORP HOECHST MARION ROUSSEL SA KOA GLASS CO LTD SCHERING AG SIGMA F AND D DIV LTD SIGMA F AND D DIV LTD NV ORGANON BACHEM FEINCHEMIKALIEN AG ROCHE QUIMICOS E FARMACEUTICOS SA FINORGA I I II I I 1/30/1990 1/31/1990 2/5/1990 I A A I I III III III IV II II 9/17/1989 9/17/1989 9/17/1989 1/27/1990 2/6/1990 2/1/1990 I I I I III 1/29/1990 1/11/1990 2/6/1990 PLIVA PYMAH CORP ATI DIV BASELL POLIOLEFINE ITALIA SRL SUB LYONDELLBASELL BASF AKTIENGESELLSCHAFT BASELL POLYOLEFINE ITALIA SRL BASELL POLIOLEFINE ITALIA SRL NIPPON OIL & FATS CO LTD CIPLA LTD I 2/2/1990 STATUS Type SUBMIT DATE A A A I I I I I I A I I III III II III II III II I III IV I II II 1/4/1990 1/4/1990 1/26/1990 1/15/1990 1/25/1990 1/26/1990 1/26/1990 1/26/1990 1/30/1990 1/27/1990 1/24/1990 1/25/1990 1/30/1990 HOLDER AMPACET CORP AMPACET CORP SUBJECT 11585 WHITE MANUFACTURED IN DERIDDER, LOUISIANA. 11560 WHITE AS MFG. IN TERRE HAUTE, IN

4Q2012

POLYPEPTIDE LABORATORIES SWEDEN AB DESMOPRESSIN AS MFG. IN MALMO, SWEDEN VETREIA PARMENSE BROMIOLI ROCCO SPA GLASS CONTAINERS AS MFG, PARMA AND BERGANTINO, ITALY CILAG AG EXXEL CONTAINER LP INFAR INDIA LTD INFAR INDIA LTD ALFA CHEMICALS ITALIANA SRL NOF CORP KORSCH PROCESSING LABORATORIES INC KYOWA HAKKO KOGYO CO LTD NANTONG GENERAL PHARMACEUTICAL FACTORY LABORATORIES PFIZER LIMITADA TERFENADINE AS MFG. IN SCHAFFHAUSEN, SWITZERLAND PACKAGING MATERIALS AS MFG. IN SOMERSET, N.J. VINCRISTINE SULPHATE (USP) AS MFG. IN WEST BENGAL, INDIA FACILITIES AND OPERATING PROCEDURES AS MFG IN W. BENGAL, INDIA NAPROXEN AS MFG. IN BOLOGNA, ITALY (DPPC) AS MFG. IN HYOGO, JAPAN FACILITIES AND OPERATING PROCEDURES AS MFG IN SOMERVILLE, N.J. AICA-RIBOSIDE AS MFG. IN HOFU CITY, JAPAN PRIMIDONE USP XXII; AS MFG. IN PEOPLES REPUBLIC OF CHINA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SSAO PAULO, BRAZIL. FACILITY FOR AZITHROMYCIN DIHYDRATE MFG. IN ZAGREB, CROATIA FACILITIES FOR MFG. STERILIZATION PROCESS INDICATORS PURELL PE 1840 H AS MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY LUPOLEN 1810 H AS MFG. IN WESSELING, GERMANY LUPOLEN 1810 E AS MFG IN WESSELING, GERMANY LUPOLEN 3020 D AS MFG. WESSLING, GERMANY DISTEAROYL PHOSPHATIDYL CHOLINE AS MFG. IN HYOGO, JAPAN NORFLOXACIN AS MFG. IN BANGALORE, INDIA

SOUTHWEST SYNTHETIC PHARMACEUTICAL KETOPROFEN USP XXII AS MFG IN REPUBLIC OF CHINA FACTORY QUIMICA SINTETICA SA CIMETIDINE USP XXII AS MFG. IN SPAIN WYETH PHARMA ZAMBON SPA FACILITIES AND OPERATING PROCEDURES IN MUENSTER, GERMANY MANUFACTURINGS SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN VICENZA, ITALY. GELATIN BASED OPTHALMIC VEHICLE AS MFG. IN LAKEWOOD, NJ METOLAZONE AS MFG. IN VERTOLAYE, FRANCE PARENTERAL AND NON PARENTERAL FLINT GLASS CONTAINERS NOCLOPROST BETA-CYCLODEXTRIN CLAHRATE MFG IN GERMANY TRIOLEIN AS MFG. IN SAINT LOUIS, MO 3,3;5- TRIIODOTHYROACETIC ACID-PRODUCT NO. T7650FD PIMOZIDE AS MFG. IN THE NETHERLANDS N-FMOC-L-LEUCINE AS MFG. IN SWITZERLAND FACILITIES AND OPERATING PROCEDURES IN SAO PAULO, BRAZIL (-)-(R)-1,2,3,4,-TETRAHYDRO-6,7-DIMETHOXY-2-METHYL-1-(3,4,5-TRIMETHOXYBENZYL) ISOQUINOLINE 2,3-DI-O-BENZOYL -L -TARTRATEAS MFG IN CHASSE-SUR-RHONE, FRANCE Page 235

4Q2012EXCEL DMF# 8430 8431 8432 8433 I 8434 I 8435 8436 8437 I 8438 8439 8440 8441 8442 8443 8444 I 8445 8446 8447 8448 8449 8450 8451 8452 8453 A 8454 8455 8456 8457 8458 8459 8460 8461 8462 8463 8464 8465 8466 I I I I I I A I I A A I I I II III II II II II I II IV III II II 2/28/1990 2/15/1990 3/7/1990 3/2/1990 2/28/1990 2/27/1990 3/5/1990 3/5/1990 2/22/1990 3/5/1990 3/8/1990 2/23/1990 3/12/1990 I I A I I I I I III II II II II I II I II 4/27/1990 2/26/1990 3/2/1990 2/27/1990 3/2/1990 2/15/1990 2/15/1990 2/28/1990 3/2/1990 A I A I A I II II III III III II II 2/5/1990 2/21/1990 2/19/1990 2/19/1990 2/19/1990 2/28/1990 10/20/1989 A I II II I 2/20/1990 2/19/1990 2/22/1990 QUIMICA SINTETICA SA ALFA WASSERMANN SPA PHARMAKAPSEL PRODUKTIONS GMBH & CO. KG PURAC BIOCHEM BV PENNISULA LABORATORIES INC LOPAREX LLC LOPAREX INC LOPAREX LLC SUMIKA FINE CHEMICALS CO LTD PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA DOW CORNING CORP PENINSULA LABS RESOLUTION CHEMICALS LIMITED BIOCHEMIC GESELLSCHAFT MBH ASAHI CHEM INDUSTRY CO LTD DEGUSSA AG DEGUSSA AG MERCK SA INDUSTRIA QUIMICAS VEGEFLORA EXTRACOES DO NORDESTE LTDA GRIFFITH MICRO SCI LTD GANES CHEMICALS INC THOROUGHBRED PLASTICS CORP EASTMAN KODAK CO PENINSULA LABS NOBEL CHEMS SPA QUIMICA SINTETICA SA JANSSEN PHARMACEUTICA INC WACKER CHEMIE GMBH LIPOID GMBH TICONA LLC IG SPRUHTECHNIK GMBH SYNTHELABO BP I 2/13/1990 STATUS Type SUBMIT DATE A A A II II III II 2/6/1990 2/6/1990 2/21/1990 2/14/1990 HOLDER ESTEVE QUIMICA SA GUSMER ENTERPRISES INC JSR LIFE SCIENCES CORP SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT GENSIA PHARMACEUTICAL INC SUBJECT METOPROLOL TATRATE AS MFG. IN BARCELONA, SPAIN PHARMACEUTICAL GRADE FILTER MEDIA MFG. PROCEDURES SYNDIOTACTIC 1, 2 POLYBUTADIENE AS MFG. IN TOKYO PHENYLALANINE-METHYLAMINOCYCLOL HCL AS MFG IN BASLE, SWITZ. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN IRVINE, CALIFORNIA. BUMETANIDE AS MFG. IN MADRID, SPAIN NAPROXEN SODIUM AS MFG. IN BOLOGNA, ITALY FACILITIES AND OPERATING PROCEDURES AS MFG. IN GERMANY CALCIUM GLUCONATE AS MFG. IN TER APELKANAAL, THE NEDERLANDS C- PEPTIDE ( 31 AMINO ACIDS) CODE # 7309 LOT # 020524 10917, S 80# SB SCK 4Z/000 MANUFACTURED IN IOWA CITY, IOWA. 10625, S 44# NT KFT H/00 4D/000 MANUFACTURED IN IOWA CITY, IOWA. 11430 S 92# BL KFT L/L 4D/000 MANUFACTURED IN IOWA CITY, IOWA. FLAVOXATE HYDROCHLORIDE AS MFG. IN GIFU PLANT, JAPAN LEVODOPA AS MFG. IN BULCIAGO, ITALY SILASTIC MDF-0372 AND MDF-0373 MEDICAL GRADE TUBING -JAPAN SUBSTANCE P CODE #7451 LOT #020973 AS MFG IN BELMONT, CA BUMETAMIDE USP AS MFG IN THE UNITED KINGDOM AMPICILLIN ANHYDRATE AS MFG. IN KUNDL, AUSTRIA PHOSPHATIDYLGLYCEROL AS MFG. IN MIYAZAKI-KEN, JAPAN

4Q2012

FACILITIES AND PROCEDURES FOR CHLORHEXIDINE AS MFG. IN KONSTANZ, GERMANY CHLORHEXIDINE AS MFG. IN KONSTANZ,GERMANY MFG. FACILITIES IN PARNAIBA-PD-BRAZIL PILOCARPINE HYDROCHLORIDE AS MFG. IN PARNAIBA, BRAZIL ETO STERILIZATION MFG. IN BOUND BROOK, NEW JERSEY TERFENADINE AS MFG. IN CARLSTADT, NEW JERSEY POLYETHYLENE TEREPHTHALATE MFG. IN LOUISVILLE, KENTUCKY FURIL DIOXIME AS MFG. IN ROCHESTER, NY DERMORPHIN CODE #8801, LOT # 020746 AS MFG IN BELMONT, CA FLUNISOLIDE AS MFG. IN MILAN, ITALY CAPTOPRIL AS MFG. IN MADRID SPAIN FACILITIES FOR PARENTERAL FACILITY AS MFG. FORT WASHINGTON, PA 1,3-DICHLOROACETONE AS MFG. IN BURGHAUSEN,GERMANY L-A-DIMYRISTOYLPHOSPHATIDYLGLYCEROL-NA AS MFG. GERMANY VECTRA LIQUID CRYSTAL POLYMERS AS MFG. IN SHELBY, NC ALBUTEROL INHALER 90 MCG. AS MFG. IN GERMANY L-LYSINE ALPHA KETO BETA METHYLVALERATE - MONTARGIS CEDEX,FR

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4Q2012EXCEL DMF# 8467 8468 8469 I 8470 8471 8472 8473 8474 8475 8476 8477 A 8478 8479 8480 8481 8482 8483 8484 8485 8486 8487 8488 I 8489 8490 8491 8492 8493 8494 8495 8496 8497 8498 8499 8500 I 8501 I 8502 8503 I I II II 4/2/1990 3/23/1990 PAREKH CHEMICALS ITALIA SPA ATOCHEM I 3/28/1990 ESTEVE QUIMICA SA I I I I I I I I I I I II II II II I II II II III II I I 3/28/1990 3/20/1990 3/23/1990 3/20/1990 4/2/1990 3/27/1990 3/27/1990 3/29/1990 3/26/1990 3/26/1990 3/23/1990 3/28/1990 ASTELLAS PHARMA INC QUIMICA SINTETICA SA EASTMAN KODAK CO BASF AKTIENGESELLSCHAFT AVTECH LABS QUIMICA SINTETICA S A SIBEFAT SPA EURAND AMERICA INC HELVOET PHARMA MARYLAND BORON BIOLOGICALS INC ELF ATOCHEM DAIICHI PHARMACEUTICAL CO LTD I I I A I I I I I I II I II IV II III II I II II I 3/16/1990 3/9/1990 3/14/1990 3/15/1990 3/13/1990 3/14/1990 3/20/1990 3/22/1990 3/19/1990 3/22/1990 3/19/1990 I I I I I A I I II II II II II I V 3/8/1990 3/21/1990 3/12/1990 3/15/1990 3/15/1990 3/15/1990 3/20/1990 3/20/1990 STATUS Type SUBMIT DATE I I II II II 3/12/1990 3/12/1990 2/14/1990 HOLDER SYNTHELABO BP SYNTHELABO BP BROCADES PHARMA BV DIV YAMANOUCHI GROUP BIOCHEMIC GESELLSCHAFT MBH SUMIKA FINE CHEMICALS CO LTD SUMIKA FINE CHEMICALS CO LTD SAFC BIOSCIENCES INC SAFC BIOSCIENCES INC SAFC BIOSCIENCES INC BIOKEN SEPARATIONS INC SUBJECT L-ORNITHINE ALPHA KETO ISOCAPROATE AS MFG. IN MONTARGIS, FR. DL-LYSINE ACETYLSALICYLATE MFG. IN MONTARGIS CEDEX, FRANCE DRIED BISMUTHSUBCITRATE SOL AS MFG. IN THE NETHERLANDS CYCLOSPORIN RECOVERY PLANT AS MFG. IN KUNDL, TYROL AUSTRIA MICONAZOLE NITRATE AS MFG IN GIFU PERFECTURE AND OSAKA, JAPAN SULINDAC AS MFG. IN GIFU PERFECTURE AND OSAKA, JAPAN 93% DME (HG)/5% NCTC (CAT. NO. 52-589) AS MFG. IN DENVER, PA BIOTAIN-MPS TM CONCENTRATE (100X) AS MFG. IN LENEXA, KS DMS-12 (100X) CONCENTRATE AS MFG. IN LENEXA, KS MFG. OF ULTRAFILTRATION MEMBRANE CARTRIDGES IN NORWOOD, MASS

4Q2012

NATIONAL INSTITUTES HEALTH NATIONAL CURRICULUM VITAE OF THE PEDIATRIC INVESTIGATORS FOR AIDS (CTG) INSTITUTE ALLERGY INFECTIOUS DISEASES EXPANSIA 5-METHYL-2-(2-THIAZOLYLAMINO) PHENOL MONOHYDROCHLORIDE PFIZER PHARMS INC PENNISULA LABORATORIES INC ALKERMES INC MALLINCKRODT INC SPARTECH PLASTICS MALLINCKRODT BAKER INC MARSAM PHARMACEUTICALS INC INTEROX CHEMICALS LTD ABBOTT LABS BIOPRODUCTS FOR SCIENCE INC FACILITY IN NAGOYA, JAPAN ANGIOTENSIN II AS MFG. IN BELMONT, CA MEDISORB (ESUB) AS MANUFACTURED IN CINCINNATI, OHIO D-PROPOXYPHENE NAPSYLATE USP CRYSTALS (ESUB) AS MANUFACTURED IN MO. H-S-LD AS MFG. IN PORTAGE, WISCONSIN PEI BONDED PHASE SILICA GEL AS MFG. IN PHILIPSBURG, N.J. FACILITIES FOR STERILE FILLING OPERATION IN CHERRY HILL, NJ. MMPP AS MFG. IN CHESHIRE, ENGLAND HYROCHLOROQUINE SULFATE AS MFG. IN NORTH CHICAGO, IL MANUFACTURING SITE, FACILITY, PERSONEL AND OPREAING PROCEDURES IN MADISON, WISCONSIN CEPHALOSPORIN (ORAL) (FK482 CEFDINIR, CI-983) MANUFACTURED IN JAPAN. NORFLOXACIN USP XXII AS MFG. IN SPAIN CIS-4-METHOXYCYCLOHEXYL P-TOLUNESSULFONATE AS MFG. IN N.Y. N-[1-(5,6,7,8-TETRAHYDRO-5,5,8,8-TETRAMETHYL 2-NAPHTHALENYL) FACILITIES AND PROCEDURES IN KALAMAZOO, MICHIGAN RANITIDINE HYDROCHLORIDE MFG. IN MADRID, SPAIN LABETALOL HYDROCHLORIDE AS MFG. IN MILAN, ITALY DIFFUTAB SIMETRY BASE AS MFG. IN VANDALIA, OHIO RUBBER CLOSURE FORMULATION B5001-60 GRAY MFG.-SALISBURY, MD. 10B-ENRICHED D,L-P-BORONO-PHENYLALANINE MFG. IN PITTSBURGH,PA FACILITIES AND PROCEDURES IN PIERRE BENITE AND JARRIE, FRANCE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN EDOGAWA-KU, TOKYO, JAPAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BARCELONA, SPAIN. CEFOPERAZONE ACID MANUFACTURED IN MILAN, ITALY. PERFLUOROOCTYLBROMIDE C8F17BR MANUFACTURED IN PIERRE BENITE AND JARRIE.

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4Q2012EXCEL DMF# 8504 I 8505 8506 I 8507 I 8508 8509 8510 8511 8512 8513 8514 8515 8516 8517 8518 8519 8520 I 8521 8522 8523 8524 8525 8526 8527 8528 8529 8530 8531 8532 8533 8534 I 8535 8536 8537 8538 8539 8540 I I I I A I II II II II II III 4/12/1990 4/3/1990 4/17/1990 4/26/1990 4/23/1990 4/23/1990 BILCHEM LTD BIOSURFACE AB LOFTUS BRYAN CHEMICALS LTD BAYER SCHERING PHARMA AG SEITZ FILTER WERKE I A I A I I I I I I I I A IV IV II II II II II II II I II I III I 4/9/1990 4/9/1990 3/30/1990 4/10/1990 4/10/1990 4/16/1990 4/16/1990 4/16/1990 4/16/1990 3/23/1990 4/17/1990 4/17/1990 3/12/1990 4/12/1990 I A I I I I I I A I A I II II II IV II II III IV III II III II III 4/5/1990 4/4/1990 4/4/1990 4/5/1990 4/2/1990 4/5/1990 3/30/1990 4/5/1990 3/28/1990 4/5/1990 4/3/1990 4/4/1990 3/27/1990 DIOSYNTH BV BACHEM AMERICAS INC BRANTFORD CHEMICALS INC CIMA LABORATORIES INC BORON BIOLOGICALS INC JOHNSON MATTHEY INC PLASTIPAK PACKAGING ORION CORP FARMOS CHEMICAL PLANT EXXONMOBIL CHEMICAL CO QUIMICA SINTETICA SA FPC FLEXIBLE PACKAGING CORP SOL PHARMACEUTICALS LIMITED EXXON CHEMICAL CO 2'-DEOXY-5-AZACYTIDINE MANUFACTURED IN OSS, THE NETHERLANDS. PARATHYROID HORMONE (1-34) HUMAN-SAN DIEGO & TORRANCE, CA. ASTEMIZOLE MANUFACTURED IN ONTARIO, CANADA. EXCIPIENT COMPONENTS MANUFACTURED IN MINNEAPOLIS, MINNESOTA. 10B-ENRICHED L-P-BORONO-PHENYLALANINE MFG. IN PITTSBURGH, PA. FENTANYL CITRATE AS MFG. IN WEST DEPTFORD, NEW JERSEY PET PLASTIC CONTAINERS AS MFG. IN PLYMOUTH, MICHIGAN 1,2-DIPALMITOYL-SN-GLYCEROL-3-PHOSPHORYLCHOLINE (DPPC), BROMINATED ISOBUTYLENE - ISOPRENE RUBBER IN LINDEN ,NJ. CIPROFLOXACIN HYDROCHLORIDE MFG. IN MADRID, SPAIN PACKAGING MATERIAL MFG. IN SCARBOROUGH, CANADA ALBUTEROL BASE MFG. IN ANDHRA PRADESH, INDIA II 3/30/1990 TASMANIAN ALKALOIDS PROPRIETARY LTD I III I 3/23/1990 3/23/1990 FERRO CORP DIMENSIONAL MERCHANDISING INC STATUS Type SUBMIT DATE I 3/28/1990 HOLDER DAIICHI PHARMACEUTICAL CO SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN EDOGAWA-KU, TOKYO, JAPAN. THERMAL PLASTIC COMPOUNDS MANUFACTURED IN HOUSTON, TEXAS. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WEST CALDWELL, NEW JERSEY. NALMEFENE HYDROCHLORIDE MANUFACTURED IN TASMANIA, AUSTRALIA.

4Q2012

PACKAGING MATERIAL XPP-323 AND XPP-626 MANUFACTURED IN MARLIN, PENNSYLVANIA. HENRY H OTTENS MANUFACTURING CO INC ARTIFICIAL SWEET CHERRY FLAVOR #5244 IN PHILADELPHIA, PA HENRY H OTTENS MANUFACTURING CO INC ARTIFICAL SWEET CHERRY FLAVOR #5243 FINE CHEMICALS CORP LTD DYNAMIT NOBEL GMBH FREEDOM CHEMICAL DIAMALT GMBH LEO PHARMACEUTICAL PRODUCTS LTD LEO PHARMACEUTICAL PRODUCTS LTD LEO PHARMACEUTICAL PRODUCTS LTD LEO PHARMACEUTICAL PRODUCTS LTD BANN LABS INC FINE ORGANICS LTD GLAXO WELLCOME INC ST GOBAIN DESJONQUERES SA SGD GLOBAL PHARMACEUTICALS INC AZAADINE MALEATE NITROGLYCERIN MFG. IN LEVERKUSEN, GERMANY DIETHYLENETRIAMINEPENTAACETIC ACID MFG. IN MUNICH, GERMANY FUSIDIC ACID AS MFG. IN BALLERUP, DENMARK SODIUM FUSIDATE MFG. IN BALLERUP, DENMARK FUCIDIN CREAM MFG. IN DUBLIN, IRELAND FUCIDIN OINTMENT MFG. IN DUBLIN, IRELAND FACILITIES AND PROCEDURES IN RAHWAY, NEW JERSEY 1,3-DICHLOROACETONE AS MFG. IN MIDDLEBROUGH CLEVELAND,ENGLAND BUILDINGS AND FACILITIES IN SEALS SANDS, ENGLAND GLASS CONTAINERS AS MFG IN COURBEVOIE, FRANCE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DON MILLS, ONTARIO, CANADA. DEXTROMETHORPHAN HYDROBROMIDE USP AS MFG. IN PONCE, P.R. DELMOPINOL HYDROCHLORIDE AS MFG. IN MALMO, SWEDEN PHENIRAMINE MALEATE AS MFG RAHDRUM,COUNTY WICKLOW,IRELAND ACARBOSE MFG WUPPERTAL, GERMANY SEITZ MEMBRACART (R) NYLON 66 MEMBRANE MFG. BAD KREUZNACH WG

IND ESQUIMEX SA KM 396 CARRETERA MEX CIMETIDINE AS MFG IN ZACAPU, MICHOACAN, MEXICO

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4Q2012EXCEL DMF# 8541 8542 8543 8544 I 8545 8546 I 8547 8548 8549 I 8550 8551 I 8552 8553 8554 I 8555 8556 8557 8558 8559 I 8560 8561 I 8562 8563 8564 8565 8566 8567 I 8568 8569 8570 8571 8572 8573 8574 8575 I I A I I I I I II III V I II II III III 5/9/1990 5/14/1990 5/14/1990 5/17/1990 4/10/1990 5/11/1990 5/22/1990 3/2/1990 EXXONMOBIL CHEMICAL COMPANY HELVOET PHARMA MARYLAND SYNERGY HEALTH EDE BV RAPID SPRAY GMBH CO KG CELLIANCE A SEROLOGICALS CO QUIMICA SINTETICA S A TOKAI ALUMINUM FOIL CO LTD TOKAI METALS CO LTD I I I I I I II II II II I 5/9/1990 5/7/1990 5/14/1990 5/14/1990 4/9/1990 5/9/1990 ISOCHEM SA AJINOMOTO CO INC MITSUBISHI KASEI DAIICHI PHARMACEUTICAL CO FARMABOIS BIOINDUSTRIA FARMACEUTICI SPA I II I 3/17/1990 4/27/1990 IPCA LABORATORIES PVT LTD SURGICAL TECHNOLOGIES I I I I III II III III I 5/5/1990 4/25/1990 5/7/1990 4/30/1990 4/19/1990 I A II II I 5/3/1990 5/2/1990 4/27/1990 I I II 5/1/1990 4/23/1990 NIPPON MEKTRON LTD FACILITIES AND OPERATING PROCEDURES IN KAAIBARAK, JAPAN I I II II II 4/19/1990 5/1/1990 5/1/1990 A II II 2/21/1990 3/2/1990 IPCA LABORATORIES LTD STATUS Type SUBMIT DATE I I I II II II I 4/24/1990 4/27/1990 4/11/1990 4/20/1990 HOLDER YONEZAWA HAMARI CHEMICALS LTD DIOSYNTH BV MEDGENIX GROUP MANDEVILLE MEDICINES SUBJECT [(S)-1,2,3,4-TETRAHYDRO-3-ISO-QUINOLINECARBOXYLIC MFG JAPAN BUPRENORPHINE AS MFG AK APELDOORN HOLLAND TIRARICOL 3,5,3 TRIIODOTHYROACETIC ACID MFG, MULHOUSE FRANCE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN AYLESBURY, ENGLAND. TRIMETHOPRIM USP MFG.IN TATLAM,MADHYA PRADESH, INDIA

4Q2012

NATURAL-SOURCE VITAMIN E ASSOCIATION NATURAL SOURCE VITAMIN E MANUFACTURED BY HENKEL CORP IN EXCELSIOR, MINNESOTA, EISAI U.S.A., INC. LUSOCHIMICA S P A PINDOLOL MANUFACTURED IN MILANO, ITALY. HAMARI COMPANY LTD NIPPON MEKTRON LTD DILTIAZEM HYDROCHLORIDE MFG YONEZAWA JAPAN PERFLUOROOCTYLBROMIDE (PFOB), C8F17BR MANUFACTURED IN KITAIBARAKI, JAPAN.

PLIVA PHARMACEUTICAL CHEMICAL FOOD & KETOPROFEN MFG IN ZAGREB, CROATIA COSMETIC INDUSTRY IMAGENTS INC RADIOCHEMICAL GALLIUM CHLORIDE GA-67 MANUFACTURED IN HOUSTON, TEXAS. YAKULT HONSHA CO LTD SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP HELVOET PHARMA MARYLAND FINE CHEMICALS CORPORATION COVALENCE COATED PRODUCTS TREND PLASTICS ESQUIRE PHARMACEUTICAL CPT-11 MFG IN CHIBA AND SHIZUOKA, JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GERMANY. RUBBER CLOSURE FORMULATION B-5300-50 GRAY MANUFACTURED IN MARYLAND. PERPHENAZINE MFG IN CAPE TOWN, SOUTH AFRICA PRODUCTS 41748-30 MFG IN COLUMBUS, GEORGIA SINGLE -DOSE POLYETHYLENE CONTAINER MFG IN ALAMEDA, CA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WESTMONT, ILLINOIS. ERTHROMYCIN ESTOLATE MANUFACTURED IN BOMBAY, INDIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SAINT PAUL, MINNESOTA. FACILITIES AND OPERATING PROCEDURES IN GENNEVILLER, FRANCE CURDLAN SULFATE SODIUM INTRAVENOUS AS MFG. IN TOKYO, JAPAN CRUDE REPIRINAST (MY-5116) MANUFACTURED IN KUROSAKI, JAPAN. DR-3355 BULK SUBSTANCE AS MFG IN TOKYO, JAPAN FLUNISOLIDE AS MFG. IN GROPELLO CAIROLI, ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FRESONARA, ITALY. AMILORIDE AS MFG. IN NOVI LIGURE AND FRESONARA, ITALY RUBBER CLOSURE FORMULATION B-5300-50 CREAM MFG SALISBURY,MD GAMMA IRRADIATION FACILITY LOCATED IN EDE, THE NETHERLANDS FACILITY FOR THE MFG OF AEROSOL SPRAY CONTAINER IN WEST GERMAN PENTEX BOVINE EXCYTE VLE GROWTH ENHANCEMENT MFG IN ILLINIOS CINOXACIN USP XXII AS MFG IN MADRID, SPAIN ALUMINUM FOR PHARMACEUTICAL PACKING PTP MFG YOKOHAMA,JAPAN E PL-11 FILM MFG. IN KANAGAWA, JAPAN

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4Q2012EXCEL DMF# 8576 8577 8578 8579 8580 8581 I 8582 8583 8584 8585 8586 8587 8588 I 8589 8590 8591 8592 8593 8594 8595 8596 8597 8598 I 8599 8600 8601 I 8602 8603 8604 8605 8606 I 8607 8608 8609 8610 8611 8612 I I I I I I II III III III III III 6/22/1990 4/4/1990 4/4/1990 4/4/1990 4/4/1990 4/4/1990 A I I I IV III II IV II 6/7/1990 6/11/1990 6/20/1990 4/4/1990 6/21/1990 NOF CORP GW PLASTICS INC NORISTON LTD GATTESFOSSE SA WISCONSIN ANALYTICAL & RESEARCH SERVICES LTD ALBEMARLE CORP SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S I I I II III 6/18/1990 6/18/1990 6/11/1990 I A A I I I I I I II II III II III I III II II II 6/5/1990 6/12/1990 6/6/1990 6/8/1990 6/7/1990 5/30/1990 6/11/1990 6/15/1990 6/12/1990 6/15/1990 I I A I A I II II II II III III III 5/28/1990 5/28/1990 5/25/1990 5/29/1990 5/29/1990 6/1/1990 6/4/1990 DELMAR CHEMICALS INC PROSINTEX SPA QUIMICA SINTETICA SA DAISO CO LTD EXXONMOBIL CHEMICAL CO NATIONAL STARCH & CHEMICAL CORP OWENS BROCKWAY INC PLASTICS AND CLOSURES DIV ABBOTT LABORATORIES MEDICHEM SA FPC FLEXIBLE PACKAGING CORP HOFFMANN LA ROCHE INC KALLE PENTAPLAST GMBH DE VONQUE INC ANGSTROM TECHOLOGIES INC KLINGE PHARMA GMBH PENINSULA LABS SHANGHAI NO 2 PHARMACEUTICAL FACTORY KURARAY CO LTD KURARAY CO LTD LOPAREX INC ETHAMBUTOL DIHYDROCHLORIDE MANUFACTURED IN CANADA. DICLOFENAC SODIUM AS MFG. IN VILLANTERIO, ITALY ACYCLOVIR AS MFG. IN MADRID, SPAIN PINDOLOL MANUFACTURED IN MASUYAMA CITY, JAPAN. ISOBUTYLENE ISOPRENE RUBBER, EXXON CHEMICAL 065 28-4979 (DERMACYL-79) AS MFG. IN BRIDGEWATER, NEW JERSEY STATUS Type SUBMIT DATE I I I I I I II I II II II 5/21/1990 5/21/1990 4/19/1990 5/22/1990 5/11/1990 5/15/1990 HOLDER ORIL INDUSTRIE ORIL UNITED COCONUT CHEMICALS DOW CHEMICAL CO MICHIGAN DIV RASCHIG GMBH GUANGDONG PHARMACEUTICAL FACTORY SUBJECT FACILITIES AND OPERATING PROCEDURES IN BOLBEC, FRANCE INDAPAMIDE AS MFG. IN BOLBEC, FRANCE FACILITIES AND PROCEDURES IN MAKAI, N.M., PHILIPPINES POLYGLYCOL E-3350 NF MFG. IN FREEPORT, TEXAS BENZYLAMINOPYRIDINE AS MFG. IN RHEIN, GERMANY INDOMETHACIN AS MFG. IN GUANGZHOU, THE REPUBLIC OF CHINA

4Q2012

PACKAGING MATERIALS MANUFACTURED IN NEWBURYPORT, MASSACHUSETTS. DOBUTAMINE HYDROCHLORIDE MANUFACTURED IN NORTH CHICAGO, ILLINOIS. GUANFACINE HYDROCHLORIDE AS MFG. IN GERONA, SPAIN SUPPOSITORY AND PILLOW PACKAGING MFG. IN ONTARIO, CANADA TRETINOIN CAPSULES AS MFG IN N.J. AND FL. GENOTHERM POLYVINYL CHLORIDE FILM-GERMANY & THE NETHERLANDS FACILITY AND OPERATING PROCEDURES IN RICHMOND HILL, NEW YORK NON-VISIBLE MATRIX OF PRINTING INKS MFG. IN ERLANGER, KY. DROLOXIFENE CITRATE IN TABLET DOSAGE FORM AS MFG. IN GERMANY ADRENOCORTICOTROPIC HORMONE MANUFACTURED IN BELMONT, CALIFORNIA. ATENOLOL USP AS MFG. IN SHANGHAI, PEOPLES REPUBLIC OF CHINA FACILITIES AND OPERATING PROCEDURES IN NIIGATA, JAPAN. (-) -HPBE AS MFG. IN NIIGATA, JAPAN 11005, S 66 #BL KFT L/L 4D/4D MANUFACTURED IN IOWA CITY, IOWA AND WEST CHICAGO, ILLINOIS. PURIFIED EGG YOLK PHOSPHATIDYL CHOLINE AS MFG. IN HYOGO, JAPAN ORAL INHALER DEVICE AS MFG. IN PLEASENT ST. BETHEL, VT. PYRAZINAMIDE AS MFG. IN WALTOO, PRETORIA. COMPRITO HD5 ATO (GELUCIRE 63/05) LUBRIFIANT WL 3284 ATO IMIPRAMINE & DESIPRAMINE IN HUMAN PLASMA S (+) IBUPROFEN AS MFG. IN ORANGEBURG, SOUTH CAROLINA. RUBBER COMPOUND 42046 AS MFG. HORSENS, DENMARK RUBBER COMPOUND 42018 AS MFG. IN HORSENS, DENMARK RUBBER COMPOUND 6247 AS MFG. IN HORSENS, DENMARK RUBBER COMPOUND 6424 AS MFG IN HORSENS, DENMARK RUBBER COMPOUND 6432 AS MFG. IN HORSENS, DENMARK

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4Q2012EXCEL DMF# 8613 8614 8615 8616 8617 8618 8619 8620 I 8621 8622 8623 8624 8625 A 8626 8627 8628 8629 8630 8631 8632 8633 8634 8635 8636 8637 8638 I 8639 I 8640 I 8641 A 8642 I 8643 I 8644 8645 8646 8647 I I I A II II II II 7/12/1990 7/10/1990 7/10/1990 7/2/1990 II 7/13/1990 II 7/13/1990 PHARMACEUTICALS WORKS POLPHARMA S.A. PHARMACEUTICAL WORKS POLPHARMA S.A. NEORX INC SANKYO CO LTD SANKYO CO LTD JIANGSU HENGRUI MEDICINE CO LTD SULFAQUINOXALINE AS MFG. IN STAROGARD, GDANSKI, POLAND SULFATHIAZOLE AS MFG IN STAROGARD, GDANSKI, POLAND RHENIUM RE 188 AS MFG. IN SEATTLE, WASHINGTON AND MISSOURI CS-622 DRUG SUBSTANCE AS MFG. IN TOKYO, JAPAN CS-622 FINISHED DOSAGE FORM AS MFG. IN TOKYO, JAPAN ETOPOSIDE USP AS MFG. IN LIANYUNGANG CITY, REPUBLIC OF CHINA II 7/13/1990 PHARMACEUTICAL WORKS POLPHARMA SA SULFADIMETHOXINE AS MFG. IN STAROGARD, GDANSKI, POLAND I 7/13/1990 PHARMACEUTICAL WORKS POLPHARMA S.A FACILITY AND OPERATING PROCEDURES IN 24-26 STAROGARD, POLAND I 7/13/1990 PHARMACEUTICAL WORKS POLPHARMA S.A FACILITIES AND PROCEDURES AT 19 PELPLINSKA STR., POLAND I I I I I A I I I I I I II II III I II II IV IV II II IV II II 6/22/1990 7/2/1990 6/26/1990 7/3/1990 7/3/1990 6/27/1990 7/6/1990 6/29/1990 7/2/1990 7/2/1990 6/21/1990 7/11/1990 7/13/1990 I I I I IV III II II II 6/26/1990 6/21/1990 6/25/1990 6/29/1990 6/28/1990 F AND C INTERNATIONAL INC LOPAREX INC BASF AKTIENGESELLSCHAFT DIOSYNTH BV CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD ISOCHEM SA CIPLA LTD EXXON CHEMICAL CO GLAXO WELLCOME INC COURTAULDS FIBRES LTD SHASUN PHARMA SOLUTIONS LTD GATTESFOSSE SA LANXESS CORPORATION BIOCHEMIC GESELLSCHAFT MBH BIOCHEMIC GESELLSCHAFT MBH JWS DELAVAU CO INC HOFFMANN LA ROCHE INC PUNCH FLAVOR #103543 AS MFG. IN CINCINNATI, OHIO 10688, S 5 MIL BU HDP 4N/000 MANUFACTURE IN IOWA CITY, IOWA. 5-ETHENYL-PYRROLIDIN-2-ONE AS MFG. IN LUDWIGSHAFEN, GERMANY TRIAZOLAM AS MFG. IN APELDOORN, THE NETHERLANDS DEXBROMPHENIRAMINE MALEATE AS MFG. IN TAIWAN, REPUB. OF CHINA TERFENADINE AS MFG. IN GENNEVILLIERS, FRANCE CIPROFLOXACIN HYDROCHLORIDE USP IN BANGALORE, INDIA ELASTOMERIC MODIFERS, CHEMICAL GRADES PA23, PA30, PA50 FACILITY IN BUCKHAVEN, UNITED KINGDOM BISULPHATE ADDUCT AS MFG. IN BUCKHAVEN, UNITED KINGDOM SULPHONAMIDO ANILINE GR 40917A AS MFG. IN NORTHUMBERLAND, ENG OCTYLDODECYL MYRISTATE (M.O.D.) MFG. IN CEDEX FRANCE MACROLEX FLUORESCENT YELLOW 10 GN AS MFG. IN BAYERWERK, WG CEFAZOLIN AS MFG. IN TYROL, AUSTRIA CEFAZOLIN CRUDE AS MFG. IN TYROL, AUSTRIA DELA-COAT CLEAR AS MFG. IN PHILADELPHIA, PENNSYLVANIA HIVID DIDEOXYCYTIDINE SYRUP AS MFG. IN NUTLEY, NEW JERSEY STATUS Type SUBMIT DATE I I I I I I A III III III II III II II III 4/4/1990 4/4/1990 4/4/1990 6/25/1990 6/22/1990 6/25/1990 6/27/1990 6/18/1990 HOLDER SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S ISOCHEM 3M PHARMS EGIS PHARMACEUTICALS CILAG AG VALSPAR KOLACK CORPORATION AG SUBJECT RUBBER COMPOUND 6433 AS MFG. IN HORSENS, DENMARK RUBBER COMPOUND 6425 AS MFG. IN HORSENS, DENMARK RUBBER COMPOUND 6426 AS MFG IN HORSENS, DENMARK 3-TRIFLUOROMETHYL-4-NITROPHENYL ISOCYANATE MFG. FRANCE AUTOHALER DEVICE AS MFG. IN GERMANY & ENGLAND SODIUM CROMOGLYCATE MFG. IN BUDAPEST, HUNGARY HYDROXYCHLOROQUINE SULFATE AS MFG. IN SCHAFFHAUSEN, SWITZ.

4Q2012

INTERIOR COATING J 3121 PIGMENTED MANUFACTURED IN KALTBRUNN, SWITZERLAND.

PHARMACEUTICAL WORKS POLPHARMA S.A SULFANILAMIDE AS MFG. IN STAROGARD, GDANSKI, POLAND

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4Q2012EXCEL DMF# 8648 8649 8650 8651 8652 8653 I 8654 8655 8656 8657 8658 8659 8660 8661 8662 8663 8664 8665 8666 8667 8668 8669 8670 I 8671 8672 8673 8674 8675 8676 8677 8678 8679 8680 8681 8682 8683 8684 8685 8686 C I I I I A I I I I I A I I I A II II II II II II II II II III II II II I II III 7/24/1990 10/16/1989 7/25/1990 7/31/1990 7/30/1990 8/1/1990 7/26/1990 7/27/1990 8/2/1990 8/2/1990 7/30/1990 7/31/1990 7/31/1990 7/23/1990 7/17/1990 8/10/1990 TEVA PHARMACEUTICAL INDUSTRIES LTD EGIS PHARMACEUTICALS HEINRICH MACK NACHF ALCHYMARS EGIS PHARMACEUTICALS DELMAR CHEMICALS INC KV PHARMACEUTICAL CO DIOSYNTH BV FINE CHEMICALS CORP LTD MITSUI CHEMICALS INC BACHEM FINE CHEMICALS INC GUILIN PHARMACEUTICAL CO LTD BACHEM FEINCHEMIKALIEN AG CHEMDEX INC BOEHRINGER INGELHEIM KG MARSHALL PLASTIC FILM INC I I C I I I I A I I I I I I A A I II II II IV III II II II II II II IV II III III V 7/12/1990 7/12/1990 7/11/1990 7/16/1990 7/17/1990 6/18/1990 7/2/1990 7/12/1990 7/19/1990 7/9/1990 7/9/1990 7/23/1990 7/20/1990 7/19/1990 7/20/1990 7/25/1990 7/18/1990 STATUS Type SUBMIT DATE I I I I I II II II I II IV 7/13/1990 7/9/1990 7/3/1990 7/9/1990 7/10/1990 6/30/1990 HOLDER MEDICHEM SA SUZHOU #1 PHARMACEUTICAL FACTORY ROCHE DIAGNOSTICS GMBH LABORATOIRES EOLLIEZ SA PHARMACIA AND UPJOHN INC PROMEDICS HEALTH CARE TOPICALS DIV UNION CARBIDE CORP NEW ZEALAND PHARMACEUTICAL LTD NEW ZEALAND PHARMACEUTICAL LTD TEVA PHARMACEUTICAL INDUSTRIES LTD LIPOID GMBH MOBAY CHEMICAL CORP VALSPAR KOLACK CORPORATION AG (FILE IS RETIRED) QUIMICA SINTETICA SA SMITH AND NEPHEW RES LTD ROHM AND HAAS CO ROHM AND HAAS CO DIOSYNTH BV MCGAW INC DOW CORNING CORP PUREPLAST INC EXXONMOBIL CHEMICAL COMPANY SCHERING AG SUBJECT AURANOFIN AS MFG. IN CELRA (GERONA), SPAIN TIMOLOL MALEATE USP AS MFG. IN SUZHOU, JIANGSU PROVINCE CHINA GALACTOSE, THERAPEUTIC GRADE MANUFACTURED IN GERMANY. FACILITY AND OPERATING PROCEDURES IN COURGEVAUX, SWITZERLAND NICOTINE INHALER AS MFG. IN HELSINGBORG, SWEDEN CHITOSAN SALTS AS MFG. IN SHIZUOKA, JAPAN FACILITY AND OPERATING PROCEDURES IN LINTON, NEW ZEALAND SODIUM CHOLATE (INTERMEDIATE) AS MFG. IN LINTON, NEW ZEALAND CARBIDOPA AS MFG. IN BULCIAGO, ITALY LIPOID E PC (EGG PHOSPHATIDYLCHOLINE) AS MFG. IN F.R.G.

4Q2012

TEXIN 480A NATURAL MANUFACTURED IN NEW MARTINSVILLE, WEST VIRGINIA. INTERIOR COATING J 3121 GOLD TRANSPARENT AS MFG. IN ITINGEN AMPEROZIDE HYDROCHLORIDE AS MFG. IN MALMO, SWEDEN GUANFACINE HYDROCHLORIDE AS MFG. IN MADRID, SPAIN BETAXOLOL HCL (NODS) AS MFG. IN HARLOW, ESSEX, UK BIOCRYL, BPA-1050 AS MFG. IN PHILADELPHIA, AND BRISTOL, PA BIOCRYL, BPA-1000 AS MFG. IN PHILADELPHIA, AND BRISTOL, PA PANCURONIUM BROMIDE AS MFG. IN OSS, THE NETHERLANDS STERILIZATION OF SOLUTION PRODUCTS IN THE (PAB) X7-2837/Q7-2837 SILICONE EMULSION AND REINFORCING AGENT GENOTHERM 1001C PVC FILM MFG. IN CAMBRIDGE, ONTARIO, CANADA HIGH DENSITY POLYETHYLENE AS MFG. IN MONT BELVIEU, TEXAS STERILE PROCESSING OF PHARMACEUTICAL PRODUCTS IN VELTEN AND BERLIN, GERMANY VERAPAMIL HYDROCHLORIDE AS MFG. IN BULCIAGO (COMO) ITALY CLOMIPHENE CITRATE TABLETS AS MFG. IN BUDAPEST, HUNGARY DIMERCAPTOSUCCINIC ACID AS MFG. IN ILLERTISSEN/BAVARIA, FRG GLIBENCLAMIDE/GLYBURIDE AS MFG. IN MILAN, ITALY CHLORPROMAZINE BASE AS MFG. IN BUDAPEST, HUNGARY METHAZOLAMIDE AS MFG. IN LASALLE, QUEBEC, CANADA ADENOSINE SUBLINGUAL TABLETS, 25 MG. AS MFG. IN ST. LOUIS, MO CLONAZEPAM AS MFG. IN APELDOORN, THE NETHERLANDS FLUTAMIDE AS MFG. IN CAPE PROVINCE, SOUTH AFRICA HZ2200J, HZ3000B AND MITSUI POLYPRO F401 - CHIBA, JAPAN ANTIDE (LH-RH ANTAGONIST) AS MFG. IN TORRANCE & SAN DIEGO, CA BUMETANIDE USP AS MFG. IN GUILIN, GUANGXI, PEOPLES REP. CHINA BULK DRUG INSULINOTROPIN AS MFG. IN BUBENDORF, SWITZERLAND FACILITY FOR GENERAL DRUM DRYING OF PRODUCTS-BOYNTON BEACH,FLA PHYSOSTIGMINE SALICYLATE (SYNTHETIC MFG.) IN INGELHEIM, FRG POLYETHYLENE FILM AS MFG. IN MARTIN, MICHIGAN

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4Q2012EXCEL DMF# 8687 8688 8689 8690 8691 8692 8693 8694 8695 8696 8697 8698 8699 A 8700 8701 8702 8703 8704 8705 8706 8707 A 8708 8709 8710 8711 8712 8713 8714 8715 8716 8717 8718 8719 8720 A 8721 8722 8723 I 8724 I II 9/7/1990 I I I I II 9/13/1990 9/6/1990 8/31/1990 RD LABORATORIES METSA SPECIALTY CHEMICALS BV BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG RAYLO CHEMICALS I A I I I I I I I I I I III II II II III II II II III III III I III 8/15/1990 9/10/1990 9/6/1990 8/10/1990 8/22/1990 8/17/1990 8/24/1990 8/24/1990 8/20/1990 8/16/1990 8/21/1990 8/31/1990 8/27/1990 A I I A A I I III I I III II I II II 8/1/1990 7/27/1990 8/14/1990 8/7/1990 8/6/1990 8/17/1990 8/7/1990 8/17/1990 STATUS Type SUBMIT DATE I I I I I I I I A I I I II II II II II II II II II II I II II 8/3/1990 8/8/1990 8/8/1990 8/3/1990 8/3/1990 8/3/1990 8/3/1990 8/3/1990 8/7/1990 8/6/1990 8/7/1990 8/2/1990 8/8/1990 HOLDER HEINRICH MACK NACHF YONEZAWA HAMARI CHEMICALS LTD PVP SOCIEDADE ANONIMA RHONE POULENC RORER GMBH PHOSPHOLIPID GMBH RHONE POULENC RORER GMBH RHONE POULENC RORER GMBH RHONE POULENC RORER GMBH FIDIA FARMACEUTICI SPA OMNICHEM NV LABORATOR MAG VIA MILANO SCHERING AG SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTD BASELL POLYOLEFINE ITALIA SRL OREGON FREEZE DRY INC KALBE FARMA PLASTEK GROUP CAMBREX PROFARMACO MILANO SRL INTERPHARM LABORATORIES LTD ICHIKAWA LAB CO LTD SUBJECT CARBINOXAMINE MALEATE AS MFG. IN ILLERTISSEN/BAVARIA, GERMANY DICLOFENAC SODIUM AS MFG. IN YAMAGATA, JAPAN L-DOPA OR LEVODOPA AS MFG. IN PARNAIBA, BRAZIL PHOSPHOLIPON MC (DMPC) AS MFG. IN COLOGNE, GERMANY PHOSPHOLIPON 90 G AS MFG. IN COLOGNE, GERMANY PHOSPHOLIPON 80 MANUFACTURED IN COLOGNE, GERMANY. PHOSPHOLIPON 90 AS MFG. IN COLOGNE, GERMANY PHOSPHOLIPON MG-NH4 AS MFG. IN COLOGNE, GERMANY FLUOXETINE HYDROCHLORIDE AS MFG. IN MILAN, ITALY ETOPOSIDE AS MFG. IN LOUVAIN-LA-NEUVE, BELGIUM FACILITY AND OPERATING PROCEDURES IN MILAN, ITALY AAMESTANE AS MFG. IN BERLIN, FEDERAL REPUBLIC OF GERMANY SULFADIAZINE AS MFG. IN SHANGHAI, THE PEOPLE REPUBLIC OF CHINA LUPOLEN 3040 D AS MFG. IN WESSLING, FEDERAL REPUBLIC OF GERMANY FACILITY AND PROCEDURES IN ALBANY, OREGON FACILITY AND PROCEDURES IN JAKARAA, INDONESIA PACKAGING MATERIALS AS MFG. IN ERIE, PENNSYLVANIA TRIAZOLAM AS MFG. IN MILANO. ITALY FACILITY FOR MFG. HUMAN INTERFERON, BETA IN NESS-ZIONA, ISRAEL DILTIAZEM HYDROCHLORIDE AS MFG. IN OBAMA CITY, JAPAN

4Q2012

DSM NUTRITIONAL PRODUCTS LTD BRANCH APROTININ AS MFG. IN AESCH, SWITZERLAND PENTAPHARM AERNI LEUCH ALFOIL FILMS AS MFG. IN BERN, SWITZERLAND AND GORDONSVILLE,VIRGINIA BASF CORP KONGO CHEMICAL CO LTD LIVRON INC EPSILON PRODUCTS CO PHARMA-WALDHOF GMBH LEO PHARMACEUTICAL PRODUCTS LTD LEO PHARMACEUTICAL PRODUCTS LTD FILTER PRODUCTS INC BASF CORPORATION PHILLIPS PETROLEUM CO BIOVAIL TECHNOLOGIES LTD REXAM CLOSURE SYSTEMS INC IBUPROFEN MANUFACTURED IN CORPUS CHRISTI, TEXAS. D-BROMPHENIRAMINE MALEATE AS MFG. IN TOYAMA-KEN, JAPAN L-TYROSINE TABLETS MANUFACTURED IN WEST NEW YORK, NEW JERSEY. POLYPROPYLENE RESINS AS MFG. IN MARCUS HOOK, PENNSYLVANIA N6-(2-ISOPENTENYL)-ADENOSINE AS MFG IN MANNHEIM, GERMANY CALCIPOTRIOL SOLUTION CREAM DRUG PRODUCT AS MFG. IN IRELAND CALCIPOTRIOL SUSPENSION CREAM DRUG PRODUCT AS MFG. IN IRELAND PHARMACEUTICAL SERIES PLEATED CARTRIDGES - SACRAMENTO, CA. OPPANOL B80 AS MFG. IN CHARLOTTE, NORTH CAROLINA CRYSTALOR POLYMETHYLPENTENE RESINS AS MFG. IN OKLAHOMA FACILITIES AND OPERATING PROCEDURES IN COSTA RICA THERMOPLASTIC CLOSURES AND PACKAGING MANUFACTURED IN HAMLET, NORTH CAROLINA. FACILITIES AND OPERATING PROCEDURES IN COLLINSVILLE, ILLINOIS FACILITY AND OPERATING PROCEDURES IN NIJMEGEN, NETHERLANDS SCOPOLAMINE AS MFG. IN INGELHEIM, GERMANY ACONIAZIDE AS MFG. IN EDMONTON, ALBERTA, CANADA

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4Q2012EXCEL DMF# 8725 8726 8727 8728 8729 I 8730 8731 8732 8733 A 8734 8735 I 8736 8737 I 8738 8739 8740 8741 8742 8743 8744 8745 8746 8747 8748 8749 8750 8751 8752 8753 8754 I 8755 I 8756 I 8757 8758 8759 8760 A I I A II II II II 9/25/1990 10/2/1990 10/2/1990 9/20/1990 SANDOZ GMBH EASTMAN KODAK CO WATSON LABORATORIES INC DANIPHARM APS I 9/26/1990 II 9/26/1990 A I I I A I I I A I A I I I I I III III III III III III I II II I II II II II IV II I 9/6/1990 9/4/1990 9/4/1990 9/4/1990 9/10/1990 9/3/1990 9/20/1990 9/20/1990 9/18/1990 9/19/1990 6/19/1990 8/30/1990 9/17/1990 9/17/1990 9/17/1990 9/18/1990 9/26/1990 SOLVIN SA BASF AKTIENGESELLSCHAFT SOLVIN S.A. BASF AKTIENGESELLSCHAFT BASF AKTIENGESELLSCHAFT BASF AKTIENGESELLSCHAFT KYOWA HAKKO KOGYO CO LTD KYOWA HAKKO KOGYO CO LTD TEVA PHARMACEUTICAL INDUSTRIES LTD AVANTI POLAR LIPIDS INC TEVA PHARMACEUTICAL INDUSTRIES LTD ASHWOOD CHEMICALS LTD DUPHAR MEDICAL DEVICES DUPHAR MEDICAL DEVICES BOEHRINGER INGELHEIM KG SIGMA F AND D DIV LTD SUMITRA PHARMACEUTICALS AND CHEMICALS LTD SUMITRA PHARMACEUTICALS AND CHEMICALS LTD TATEISHI SEIYAKU CO LTD A II I 9/13/1990 9/12/1990 I III II 8/29/1990 9/13/1990 I I I I I III IV 8/29/1990 9/12/1990 8/29/1990 9/17/1990 STATUS Type SUBMIT DATE I I I I II I II II II 9/11/1990 9/11/1990 9/14/1990 9/7/1990 9/12/1990 HOLDER E MERCK E MERCK DM GRAHAM LABORATORIES INC HEUMANN SHANGHAI BIOCHEMICAL AND PHARMACEUTICAL LABORATORIES SHAKLEE USA INC ESTEVE QUIMICA SA SCHUBERT SEALS A/S NUTRINOVA NUTRITION SPECIALITIES AND FOOD INGREDIENTS GMBH SCHUBERT SEALS A/S PACIFIC NORTHWEST NATIONAL LABORATORY SYN TECH CHEM AND PHARM CO LTD NORTHVIEW PACIFIC LABORATORIES INC SUBJECT EUSOLEX 6300 OIL SOLUBLE UV-B-FILTER MFG.-GERNSHEIM, GERMANY FACILITIES AND PROCEDURES IN GERNSHEIM, FED. REP. OF GERMANY IBUPROFEN S (+) TABLETS AS MFG. IN HOBART, NEW YORK E-CLOMIPHENE-CITRATE AS MFG. IN FEUCHT, GERMANY MENOTROPINS AS MFG. IN SHANGHAI, PEOPLE'S REP. OF CHINA FACILITY AND OPERATING PROCEDURES MFG. IN NORMAN, OKLAHOMA FACILITY AND OPERATING PROCEDURES AS MFG. CELRA, SPAIN RUBBER COMPOUND 36141 AS MFG. IN HORSENS, DENMARK ACESULFAME POTASSIUM MANUFACTURED IN GERMANY. RUBBER COMPOUND 36140 AS MFG. IN HORSENS, DEMARK YTTRIUM-90 (Y-90) AS MFG. IN RICHLAND, WASHINGTON CHLORZOXAZONE USPXXII AS MFG. IN HSIN YING, TAIWAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BERKELEY, CALIFORNIA. DIOFAN 193 D AS MFG. IN LUDWIGSHAFEN, GERMANY DIOFAN 185 D AS MFG. IN LUDWIGSHAFEN, GERMANY DIOFAN 233 D AS MFG. IN LUDWIGSHAFEN, GERMANY DIOFAN A 735 AS MFG. IN LUDWIGSHAFEN, GERMANY

4Q2012

TERLUX 2802 TR AS MFG. IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY DIOFAN A 710 AS MFG. IN LUDWIGSHAFEN, GERMANY FACILITIES AND PROCEDURES IN SHIZUOKA PREFECTURE, JAPAN CI-920 (FOSTRIECIN) BULK FORM AS MFG. IN TOKYO, JAPAN NAPROXEN SODIUM AS MFG. IN BULCIAGO (COMO), ITALY FACILITIES AND OPERATING PROCEDURES IN ALABASTER, ALABAMA NAPROXEN AS MFG. IN BULCIAGO (COMO), ITALY DIMETHYLAMINOETHYLCHLORIDE HCL MFG. IN BALEY, ENGLAND AROPINE/PRALIDOXIME CHLORIDE INJECTION (PERFORATED NEEDLE) AROPINE/PRALIDOXIME CHLORIDE INJECTION (RETRACTION NEEDLE) POLY-(D,L-LACTIDE-CO-GLYCOLIDE) 50:50 MANUFACTURED IN GERMANY. D-ARGININE HYDROCHLORIDE MANUFACTURED IN ST. LOUIS, MISSOURI. FACILITIES AND OPERATING PROCEDURES IN ANDHRA PRADESH, INDIA IBUPROFEN AS MFG. IN ANDHRA PRADESH, INDIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERALOPERATING PROCEDURES IN TOKYO, JAPAN 6-APA (6 AMINOPENICILLANIC ACID) AS MFG. IN KUNDL, AUSTRIA 4-(ACETYLAMINO)PHENYL ALL-TRANS-RETINOATE AS MFG., NEW YORK TRANSDERMAL ESTRADIOL PACH AS MFG. IN CORONA, CALIFORNIA LACTULOSE SYRUP AS MFG. IN NIBE, DENMARK

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4Q2012EXCEL DMF# 8761 8762 8763 8764 8765 A 8766 8767 8768 8769 8770 8771 8772 8773 8774 8775 8776 8777 A 8778 A 8779 8780 8781 I 8782 8783 8784 8785 8786 8787 8788 I 8789 8790 8791 8792 8793 8794 8795 8796 8797 I I A I I I I I I IV III III II II II I III I 10/9/1990 10/1/1990 10/5/1990 10/22/1990 10/19/1990 10/18/1990 10/25/1990 9/7/1990 10/10/1990 A A A I A I II III II I V II III 10/11/1990 10/17/1990 10/12/1990 10/10/1990 10/16/1990 10/10/1990 10/21/1990 A I III I V 10/5/1990 10/15/1990 10/19/1990 DUPONT ENGINEERING POLYMERS PEPTISYNTHA III 9/24/1990 BASF CORP I I I I I I I I I I I III III III III III III III III III III III III 9/17/1990 9/17/1990 9/17/1990 9/17/1990 9/17/1990 9/17/1990 9/17/1990 9/17/1990 9/17/1990 9/17/1990 9/17/1990 9/28/1990 SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S ST GOBAIN PERFORMANCE PLASTICS STATUS Type SUBMIT DATE I I A I III III III II III 9/28/1990 10/1/1990 10/1/1990 9/26/1990 9/24/1990 HOLDER ALUMINUM COMPANY OF AMERICA AVANTI POLAR LIPIDS INC AMPACET CORP TEVA PHARMACEUTICAL INC ARKEMA INC SUBJECT PHAR 9300 AS MFG. IN PITTSBURGH, PENNSYLVANIA PACKAGING MATERIALS AS MFG. IN ALABASTER, ALABAMA

4Q2012

11447 WHITE PE/MB MANUFACTURED IN TERRE HAUTE, INDIANA AND DERIDDER, LA. TERFENADINE AS MFG. IN PETAH TIQVA, ISRAEL PLEXIGLAS DR AS MFG. IN PHILADELPHIA, PENNSYLVANIA ALTOGLAS DIVISION, 2000 MARKET STREET PHILADELPHIA, PA19103-3222 RUBBER COMPOUND 42047 AS MFG. IN HORSENS, DENMARK RUBBER COMPOUND 42045 AS MFG. IN HORSENS, DENMARK RUBBER COMPOUND 42044 AS MFG. IN HORSENS, DENMARK RUBBER COMPOUND 42043 AS MFG. IN HORSENS, DENMARK RUBBER COMPOUND 41010 AS MFG. IN HORSENS, DENMARK RUBBER COMPOUND 41008 AS MFG. IN HORSENS, DENMARK RUBBER COMPOUND 6446 MANUFACTURED IN HORSENS, DENMARK. RUBBER COMPOUND 6445 MANUFACTURED IN HORSENS, DENMARK. RUBBER COMPOUND 6443 MANUFACTURED IN HORSENS, DENMARK. RUBBER COMPOUND 6442 AS MFG. IN HORSENS, DENMARK RUBBER COMPOUND 6427 AS MFG. IN HORSENS, DENMARK RIGID PVC C/1/S #7000 SILICONE RELEASE COATING MANUFACTURED IN WORCESTER, MASSACHUSETTS. EMULDUR PR 8381 AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY HYTREL 8238 POLYESTER ELASTOMER MANUFACTURED IN WILMINGTON, DELAWARE. FACILITIES AND OPERATING PROCEDURES IN BRUSSELS, BELGIUM

NATIONAL INSTITUTES HEALTH NATIONAL REFERENCE INFORMATION (CURRICULA VITAE) INSTITUTE ALLERGY INFECTIOUS DISEASES LUBRIZOL ADVANCED MATERIALS INC CARBOPOL SALTS AS MFG. BY BFGOODRICH COMPANY LOPAREX LLC FINORGA MADIS LABORATORY PHARMACHEMIE BV BIOSPECIA LTD ARCO CHEMICAL COMPANY DIV OF ATLANTIC RICHFIELD CO HERCULES INC BASF AKTIENGESELLSCHAFT LOPAREX LLC NIPPON STEEL CHEMICALS CO LTD BACHEM FEINCHEMIKALIEN AG EGIS PHARMACEUTICALS GLAXO OPERATIONS UK LTD TOYO ALUMINUM KLINGE PHARMA GMBH 10929, S 53# SB SCK 6X/000 MANUFACTURED IN NEENAH, WISCONSIN. ADAPALENE AS MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE FACILITIES AND OPERATING PROCEDURES IN SOUTH HACKENSACK, NJ STERILE MANUFACTURING FACILITY IN HAARLEM,NETHERLANDS HUMAN CHORIONIC GONADOTROPHIN MANUFACTURED IN KENT, ENGLAND. FIBERSORB SUPERABSORBENT MATERIALS 7000, 7200 AND 7500 IN PA PENTALYN H SYNTHETIC RESIN AS MFG. IN BURLINGTON, NJ LUPOLEN 3025 K MANUFACTURED IN WESSLING, FEDERAL REPUBLIC OF GERMANY. SILICONE RELEASE LINERS MANUFACTURED IN IOWA CITY, IA AND EDEN, NC (S)-1,2,3,4-TETRAHYDROISOQUINOLINE-3-CARBOXYLIC ACID-JAPAN CYT-379 AS MFG. IN BUBENDORF, SWITZERLAND NIFEDIPINE AS MFG. IN BUDAPEST, HUNGARY FACILITIES AND OPERATING PROCEDURES AT BARNARD CASTLE, UK PAPER/LDPE/AL FOIL/ADHESIVE/ACRYLONITRILE FILM IN JAPAN MANUFACTURING FACILITY IN KILLORGLIN, IRELAND

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4Q2012EXCEL DMF# 8798 8799 8800 8801 8802 8803 8804 I 8805 8806 8807 8808 8809 8810 8811 8812 8813 8814 8815 8816 8817 8818 8819 8820 8821 8822 8823 8824 8825 8826 8827 8828 8829 8830 8831 8832 8833 8834 8835 8836 8837 I A I I I I I I I I I I A A I I A I I N N N I I I I I I A I I A A II II II IV II I III II III V III 11/9/1990 11/20/1990 11/16/1990 11/8/1990 11/15/1990 11/15/1990 11/5/1990 10/10/1990 10/31/1990 11/16/1990 11/19/1990 II II III II II II II II I II II I II II II II II III II 10/31/1990 10/30/1990 11/2/1990 10/31/1990 10/31/1990 11/6/1990 9/18/1990 11/5/1990 11/5/1990 11/5/1990 11/9/1990 11/9/1990 11/6/1990 11/7/1990 11/9/1990 11/9/1990 10/31/1990 10/11/1990 10/11/1990 STATUS Type SUBMIT DATE A I I I I A III II II II II III II 10/17/1990 10/23/1990 10/25/1990 10/29/1990 10/24/1990 10/24/1990 11/1/1990 HOLDER LOPAREX BV TATEISHI SEIYAKU CO LTD DELMAR CHEMICALS INC HAUSER CHEMICAL RESEARCH INC GEDEON RICHTER LTD B LAUFENBERG GMBH MALLADI DRUGS AND PHARMACEUTICALS LTD SUMITOMO CHEMICAL CO LTD GEDEON RICHTER PLC NYPRO CAROLINA WATSON LABORATORIES INC CILAG AG AMERSHAM CORP PIONEER PHARMACEUTICALS CO INC PROFARMACO SRL FAR RESEARCH INC FAR RESEARCH INC ASAHI GLASS CO LTD ASAHI GLASS CO LTD AVANTI POLAR LIPIDS INC SIGNA SA DE CV ROUSSEL-UCLAF CYCLO PRODUCTS INC PFIZER INC SCHOELLER AND HOESCH GMBH SCHOELLER AND HOESCH GMBH NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER HASHIMOTO CHEMICAL INDUSTRIES CO LTD SODIUM FLUORIDE AS MFG. IN OSAKA, JAPAN KYOWA HAKKO KOGYO CO LTD HAIMEN PHARM FACTORY SC JOHNSON & SON INC IAF BIOCHEM INTERNATIONAL INC CREATIVE PRODUCTS INC DANAPAK FLEXIBLES AS ARCHIMICA SPA LOHMANN GMBH & CO KG STERIS ISOMEDIX SERVICES HEUCK FOLIEN GESELLSCHAFT MBH ADENOSINE MANUFACTURED A HOFU CITY PLANT, JAPAN DAUNORUBICIN HYDROCHLORIDE AS MFG. IN JIAOJIANG CITY, CHINA PRIMAFRESH HS AS MFG. IN STURTEVANT, WISCONSIN ACONIAZIDE TABLETS 650 MG. AS MFG. BY PFIZER - CANADA FACILITIES AND OPERATING PROCEDURES IN ROSSVILLE, ILLINOIS COMPOUND PACKAGING MATERIAL AS MFG. IN ODENSE S., DENMARK ATENOLOL AS MFG. IN VARESE, ITALY PARATEX III/40 AS MFG. IN NEUWIED AND DIERDOEF, GERMANY CONTRACT STERILIZATION FACILITY IN SPARTANBURG, SOUTH CAROLINA. METALLIZED POLYESTER FILMS AS MFG. IN BAUMGARTENBERG, AUSTRI SUBJECT GELROLEASE 111/80, PS 29.701 AS MFG. IN THE NETHERLANDS DILTIAZEM HYDROCHLORIDE AS MFG. IN TOKYO, JAPAN PYRIDOSTIGMINE BROMIDE AS MFG. IN VILLE LASALLE,QUEBEC,CANADA TAXOL MANUFACTURED IN BOULDER, COLORADO. DIHYDROLYSERGOL AS MFG. IN BUDAPEST, HUNGARY

4Q2012

POLYESTERFILM MANUFACTURED IN HULS, FEDERAL REPUBLIC OF GERMANY. EPHEDRINE HYDROCHLORIDE AS MFG. IN TAMIL NADU, INDIA GLIPIZIDE AS MFG. IN GIFU PREFECTURE AND OSAKA, JAPAN LEVONORGESTREL AS MFG. IN BUDAPEST, HUNGARY MOLDED MEMBRANE PORT #03-20-16-422 AS MFG. IN BURLINGTON, NC IRON DEXTRAN, 5% SOLUTION AS MFG. IN NORTH CHICAGO, ILLINOIS 2-BENZYLAMINO-PYRIDINE MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND. YTTRIUM CHLORIDE (Y-90) AS MFG. IN BUCKS, ENGLAND ELMIRON (PENTOSAN POLYSULFATE SODIUM)CAPSULES 100MG, NJ LOXAPINE SUCCINATE AS MFG. IN MILAN, ITALY FACILITY IN PALM BAY, FLORIDA MONOBENZONE AS MFG. IN PALM BAY, FLORIDA PERFLUOROOCTYLBROMIDE AS MFG. IN CHIBA, JAPAN FACILITES AND OPERATING PROCEDURES IN CHIBA, JAPAN GLYCEROPHOSPHOCHOLINE.CDC12.CELITE AS MFG. IN ALABASTER, AL AZT AS MFG. IN BRANTFORD, ONTARIO, CANADA ESTRADIOL AS MFG. BY DIOSYNTH BV IN OSS, HOLLAND BIOTIN AS MFG. IN LOS ANGELES, CALIFORNIA TRIAMCINOLONE ACETONIDE AS MFG. IN KALAMAZOO, MICHIGAN GEFOLUX TDS/HF GEFOLUX TDS/M AS MANUFACTURED IN GERNSBACH, REPUBLIC OF GERMANY.

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4Q2012EXCEL DMF# 8838 8839 I 8840 8841 8842 8843 8844 8845 8846 8847 8848 8849 8850 8851 8852 8853 8854 I 8855 8856 A 8857 I 8858 8859 8860 8861 8862 8863 8864 8865 8866 8867 8868 8869 8870 8871 8872 I 8873 8874 I I III II 12/6/1990 12/4/1990 A I I I I N A I A I I I A I II I II III I II III IV II 11/19/1990 11/30/1990 11/30/1990 11/11/1990 11/30/1990 12/3/1990 12/4/1990 11/30/1990 12/4/1990 II II II II V 11/29/1990 11/26/1990 11/26/1990 11/29/1990 11/20/1990 CHEMAGIS LTD ZAMBON SPA ZAMBON SPA RIEDEL DEHAEN AG PHARMACONSULTANT INC NOT AN ASSIGNED NUMBER LUNDBECK PHARMACEUTICALS ITALY SPA TAENAKA KOGYO CO LTD TAENAKA KOGYO CO LTD FRANTSCHACH INNCOAT GMBH ORLOVE GROUP BIOCHEMIE S.A. AMCOR FLEXIBLES ITALIA SRL BRISTOL MYERS PRODUCTS DIV BRISTOL MYERS CO OWENS ILLINOIS INC QUIMICA SINTETICA S A CLOMIPRAMINE HYDROCHLORIDE MANUFACTURED IN PADOVA, ITALY. FACILITIES AND OPERATING PROCEDURES IN MOBARA CITY, JAPAN L-CYSTEINE MONOHYDROCHLORIDE MONOHYDRATE MFG. IN JAPAN AZETIN SILAZET MANUFACTURED IN RAUBLING, GERMANY. FACILITIES AND OPERATING PROCEDURES IN FORT LAUDERDALE, FLA. ANHYDROUS AMPICILLIN INTERMEDIATE NON-STERILE BULK MFG. SPAIN PAPER/ALUMINUM/POLYETHYLENE LAMINATE DRUG MFG. IN ITALY TRI-BUFFERED BUFFERIN AS MFG. IN MORRISVILLE, NORTH CAROLINA PACKAGING MATERIALS AS MFG IN BALTIMORE MD PLANT ACEBUTOLOL HYDROCHLORIDE AS MFG. IN MADRID, SPAIN I 11/4/1990 A II II 11/26/1990 11/20/1990 NV ORGANON SHANGHAI ZIYUAN PHARMACEUTICAL CO LTD GENZYME FINE CHEMICALS I I I I I I I I I I I I A I II I I II II II I II II II II II II II I 11/16/1990 11/21/1990 11/16/1990 11/15/1990 11/15/1990 11/15/1990 11/15/1990 11/16/1990 8/10/1990 8/10/1990 11/16/1990 11/21/1990 11/21/1990 11/21/1990 11/27/1990 SIPSY SNC KINERTON LTD MALLINCKRODT CANADA INC KOPRAN LTD KOPRAN LTD KOPRAN LTD KOPRAN LTD MALLINCKRODT CANADA INC 3M HEALTH CARE LTD 3M HEALTH CARE LTD MALLINCKRODT CANADA INC BACHEM INC ACS DOBFAR SPA QUIMICA SINTETICA S A NIPPON FINE CHEMICAL COMPANY LTD STATUS Type SUBMIT DATE I II I 11/9/1990 11/12/1990 HOLDER RECORDATI INDUSTRIA CHIMICA SPA KYOWA HAKKO USA INC SUBJECT METOPROLOL TARTRATE AS MFG. IN LATINA, ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ASHIKAGA-SHI, JAPAN. TRICAINE METHANE SULFONATE AS MFG. IN AVRILLE, FRANCE FACILITY AND OPERATING PROCEDURES IN BLANCHARDSTOWN, IRELAND FACILITIES AND OPERATING PROCEDURES IN POINTE CLAIRE, CANADA AMPICILLIN TRIHYDRATE MFG. IN MAHARASHTRA, INDIA CLOXACILLIN SODIUM MANUFACTURED IN MAHARASHTRA, INDIA. AMOXYCILLIN TRIHYDRATE MFG. IN MAHARASHTRA, INDIA FACILITIES AND OPERATIONS IN MAHARASHTRA, INDIA X-RAY CONTRAST MEDIA AS MFG. IN POINTE CLAIRE, QUEBEC, CANADA SALSALATE AS MFG. IN LEICESTERSHIRE, ENGLAND MANUFACTURE OF FLECAINIDE ACETATE

4Q2012

HEXABRIX X-RAY CONTRAST MEDIA MANUFACTURED IN POINTE CLAIRE,CANADA EEL CALCITONIN MANUFACTURED IN TORRANCE AND SAN DIEGO, CALIFORNIA. 7-AMINO-3-CHLORO CEPHEM ESTER AS MFG. IN TRIBIANO (MI), ITALY CHLORAMPHENICOL PALMITATE AS MFG. IN MADRID, SPAIN MANUFACTURTING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HYOGO, JAPAN. 16-ALPHA-HYDROXYPREDNISOLONE MANUFACTURED IN OSS, THE NETHERLANDS. DOBUTAMINE HYDROCHLORIDE AS MANUFACTURED IN SHANGHAI, CHINA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HAVERHILL, ENGLAND. PENTOXYFYLLINE AS MFG. IN BEER SHEVA, ISRAEL TRIAZOLAM AS MFG. IN VICENZA, ITALY ALPRAZOLAM AS MFG. IN VICENZA, ITALY BENZOPHENONE -3 (OXYBENZONE) AS MFG. IN SEELZE, GERMANY DRUG INTERACTION STUDY ON BROMOCRIPTINE AND TORECAN

HENRY H OTTENS MANUFACTURING CO INC ARTIFICIAL BING CHERRY AND CHERRY RASPBERRY FLAVORS MFG. P.A.

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4Q2012EXCEL DMF# 8875 8876 I 8877 8878 8879 8880 8881 8882 8883 8884 8885 8886 8887 8888 A 8889 I 8890 8891 I 8892 8893 8894 I 8895 8896 8897 8898 8899 8900 I 8901 8902 8903 8904 8905 8906 8907 8908 I 8909 I II 12/31/1990 LEBSA LABORATORIOS ESPINOSY BOFILL SA I I I A I I A II II I II I IV IV I 12/13/1990 12/11/1990 12/30/1990 12/20/1990 12/20/1990 11/2/1990 12/27/1990 12/31/1990 BOEHRINGER INGELHEIM PHARMA KG CHATTEM CHEMICALS UNION CARBIDE CORP ABBVIE INC CHEMIE LINZ GES MBH FLAVOR NORTH AMERICA INC LIPOID GMBH LEBSA CTRA DE LHOSPITALET 30 I I I I I II II II II III I 12/10/1990 12/18/1990 12/17/1990 12/21/1990 12/19/1990 12/19/1990 AMICON DIV WR GRACE AND CO LEO PHARMACEUTICAL PRODUCTS LTD SUN CHEMICAL CO LTD BAXTER HEALTHCARE CORP HELVOET PHARMA MARYLAND TAKEDA CHEMICAL INDUSTRIES LTD I A II II I 12/13/1990 12/17/1990 12/10/1990 BACHEM AG KYOWA HAKKO BIO CO LTD MIDWEST RES INST I II I 6/28/1990 12/12/1990 III 12/11/1990 FOLIENWALZWERK BRUEDER TECH AKTIENGESELLSCHAFT DAIICHI PHARMACEUTICAL CO LTD SUN CHEMICAL CO DOUBLE LAMINATED FOIL OPA/ALU/PVC AS MFG. IN AUSTRIA I I I I A A A A I A I I III III II III III III III II II II II 12/10/1990 12/6/1990 12/6/1990 12/7/1990 12/10/1990 12/10/1990 12/10/1990 12/10/1990 12/7/1990 12/10/1990 12/11/1990 12/13/1990 IMHAUSEN CHEMIE GMBH 4P FOLIE FORCHHEIM GMBH 4P FOLIE FORCHHEIM GMBH FINE ORGANICS LTD TAISEI KAKO CO LTD TAISEI KAKO CO LTD TAISEI KAKO CO LTD TAISEI KAKO CO LTD REPLIGEN CORPORATION FINE ORGANICS LTD DAIICHI PHARMACEUTICAL CO LTD STATUS Type SUBMIT DATE I II II 11/28/1990 12/14/1990 HOLDER DENKA PHARMCEUTICAL CO LTD AVECIA INC. SUBJECT MENOTROPIN AS MFG. IN KANAGAWA, JAPAN

4Q2012

SDM-75 (20 % NITROGLYCERIN IN SOLVATED ACRYLATE POLYMER) MANUFACTURED IN TAMAQUA, PA FACILITIES AND GENERAL OPERATING PROCEDURES IN LAHR, GERMANY PVC RIGID FILM TYPE 41121 AS MFG. IN FORCHHEIM, GERMANY PVC RIGID FILM TYPE 51520 MANUFACTURED IN FORCHHEIM, GERMANY. S-1,2,3,4-TETRAHYDROISOQUINOLINE-3- ACID SALT MFG. IN ENGLAND VIALS AND AMPULES AS MFG. IN KITA-KU, OSAKA, JAPAN CONTAINERS FOR CARTELOL EYE DROPS AS MFG. IN GIFU, JAPAN TAS-SHEETS FOR PKG. TABLETS AND CAPSULES MFG. GIFU, JAPAN PLASTIC BOTTLES AS MFG. IN GIFU AND OSAKA, JAPAN FAST FLOW IMMOBILIZED RECOMBINANT PROTEIN A IN MASSACHUSETTS SULPHAZINE AS MFG. IN CLEVELAND, ENGLAND PANTETHINE BULK SUBSTANCE AS MFG. IN AKITA, JAPAN

VERTELLUS PERFORMANCE MATERIALS INC ACETYLTRI-N-HEXYL CITRATE (ATHC) MANUFACTURED IN NORTH CAROLINA.

PANTOSIN 200 MG TABLETS MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SAITAMA, JAPAN. CALCITONIN (SALMON) (BULK) MANUFACTURED IN SWITZERLAND. MANUFACTURING AND QUALITY INFORMATION ON L-GLUTATHIONE REDUCED MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MISSOURI. MAREX SILICA PAE MEDIA MANUFACTURED IN DANVERS, MASACHUSETTS. FUCIDIN GEL DRUG PRODUCT MANUFACTURED IN DUBLIN, IRELAND. TIAZEPN AS MFG. IN SAITAMA, JAPAN ANTI-PROTEIN C AFFINITY MATRIX AS MFG. IN HAYWARD, CALIFORNIA RUBBER CLOSURE FORMULATION MANUFACTURED IN SALISBURY, MARYLAND. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SHONAN PLANT. ISOPROTERENOL HYDROCHLORIDE AS MFG. IN INGELHEIM ALUMINATE (1-),[CARBONATO(2-)-0] DIHYDROXY-SODIUM IN TENN. FACILITIES IN SHIZOUKA, JAPAN BUTORPHANOL TARTRATE (ESUB) AS MANUFACTURED IN CHICAGO, ILLINOIS FACILITIES AND OPERATING PROCEDURES IN LINZ, AUSTRIA ARTIFICIAL RASPBERRY FLAVOR #906.014/WC AS MFG. IN ILLINOIS LIPOID S PC-3 AS MFG. IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BARCELONA, SPAIN. OXODIPINE AS MFG. IN BARCELONA, SPAIN.

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4Q2012EXCEL DMF# 8910 8911 I 8912 8913 I 8914 8915 8916 8917 8918 8919 8920 I 8921 8922 8923 8924 A 8925 8926 8927 8928 8929 8930 I 8931 8932 I 8933 8934 8935 8936 8937 8938 8939 8940 8941 8942 8943 8944 I 8945 I IV 1/22/1991 I I A I I I I A A I I III II II III IV III IV II III II III II 1/17/1991 10/31/1990 11/21/1990 1/3/1991 12/28/1990 1/7/1991 12/4/1990 1/18/1991 1/25/1991 1/17/1991 1/18/1991 1/21/1991 4P VERPACKUNGEN RONSBERG GMBH SIBEFAT SRL QUIMICA SINTETICA SA MOBAY CHEMICAL CORP WILD FLAVORS INC PMS CONSOLIDATED GUANDONG PING KANG PHARM BASF PHARMACHEMIKALIEN GMBH CO KG HERRMANN AG RHONE POULENC RORER INC AMPACET CORP SCHERING PHARMACEUTICAL CORPORATION SEPPIC A III I 1/14/1991 10/25/1990 PRETIUM PACKAGING BOEHRINGER MANNHEIM ITALIA SPA A I I A I III I II II II I 1/7/1991 1/2/1991 1/9/1991 1/11/1991 1/15/1991 1/17/1991 I A I I III II II 1/24/1991 1/9/1991 1/16/1991 1/16/1991 BOEHRINGER MANNHEIM GMBH ST GOBAIN DESJONQUERES SA SGD SOCIETA ITALIANA CORTICOSTEROIDI SPA LABORATORIO CHIMICO INTERNAZIONALE SPA SOLVIN SA RELIABLE CHEMICAL CO CAMBREX PROFARMACO MILANO SRL APOTEX PHARMACHEM INC 3M PHARMS GATTESFOSSE SA A I I I I I II II II II II II I 1/3/1991 1/4/1991 1/3/1991 1/2/1991 1/9/1991 1/10/1991 1/3/1991 FUJIMOTO CHEMICALS CO LTD ZENECA PHARMACEUTICALS MEDICHEM SA ABBOTT LABS PHARMACIA AND UPJOHN INC MAPRIMED SA RECHERCHE SYNTEX FRANCE SA DACARBAZINE (BULK) AS MFG. IN HYOGO, JAPAN DIPRIVAN AS MFG. IN MILAN, ITALY DICLOFENAC SODIUM AS MFG. IN GERONA, SPAIN RAPAMYCIN CRUDE OIL AS MFG. IN NORTH CHICAGO, ILLINOIS 3-OXO-4-AZAANDROST-5-ENE-17 BETA-CARBOXYLIC ACID, IN MICHIGAN NICARDIPINE HYDROCHLORIDE AS MFG. IN BUENOS AIRES, ARGENTINA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LEUVILLE-SUR-ORGE, FRANCE. FACILITIES AND OPERATING PROCEDURES IN MANNHEIM, GERMANY GLASS PACKAGING MATERIAL MANUFACTURED IN FRANCE AND GERMANY. FLUMETHASONE PIVALATE AS MFG. IN RHO, ITALY DICLOFENAC SODIUM AS MFG. IN MILAN , ITALY DIOFAN 3193 AS MFG. IN LUDWIGSHAFEN, GERMANY FACILITIES AND OPERATING PROCEDURES IN ST. LOUIS, MISSOURI LOXAPINE HYDROCHLORIDE AS MFG. IN MILAN, ITALY BUSPIRONE HYDROCHLORIDE AS MFG. IN BRANTFORD, ONTARIO, CANADA TRANSDERMAL PACH LY188035 AS MFG. IN ST. PAUL, MINNESOTA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SAINT-PRIEST, FRANCE PACKAGING MATERIALS AS MFG. IN GRAIN VALLEY, MO, SEYMOUR, IN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MONZA, ITALY. FLEXIBLE FILM LAMINATE PVC/PE/PVDC AS MFG. IN GERMANY SULINDAC AS MFG. IN LAHR, GERMANY BY IMHAUSEN CHEMIE GMBH CHLORAMPHENICOL AS MFG. IN MADRID, SPAIN MAKROLON FRC 2458-8227 AS MFG. IN PITTSBURGH, PENNSYLVANIA CHERRY RASPBERRY FLAVOR #257691T AS MFG. IN CINCINNATI, OHIO COLORANT #56429 CMB AS MFG. IN CORALSPRINGS, FLORIDA EMPTY HARD GELATIN CAPSULES AS MFG. IN KAIPING, CHINA OXYMETAZOLINE HYROCHLORIDE AS MFG. IN MINDEN, GERMANY I III I 12/18/1990 1/3/1991 SOLVAY & CIE SA STATUS Type SUBMIT DATE I II I 12/27/1990 12/27/1990 HOLDER LIPHA PHARMACEUTICALS INC KING PHARMACEUTICALS INC SUBJECT 5% HYDROXOCOBALAMIN INJECTION AS MFG. IN ALBUQUERQUE, NM MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BRISTOL, TENNESSEE. ELTEX P HP 200 AS MFG. IN SARRALBE, FRANCE

4Q2012

AMAGASAKI CHEMICAL INDUSTRIES CO LTD FACILITIES AND PROCEDURES IN AMAGASAKI CITY, HYOGO, JAPAN

RAW MATERIALS IN THE PRODUCTION OF HDPE SCREW CAPS FOR DRUG PACKAGING PROMAZINE HYDROCHLORIDE AS MFG. IN FRANCE 11656 WHITE PE/MB AS MFG. IN DERIDDER LA. ALCLOMETASONE DIPROPIONATE, USP AS MFG. MANATI, PUERTO RICO MONTANIDE ISA 70 AS MFG. IN CASTRES, FRANCE

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4Q2012EXCEL DMF# 8946 8947 8948 8949 8950 8951 8952 8953 8954 8955 8956 8957 I 8958 8959 8960 8961 I 8962 8963 8964 8965 I 8966 8967 8968 8969 8970 8971 8972 8973 8974 8975 8976 8977 I 8978 I 8979 8980 8981 A I I II III III 2/15/1991 2/11/1991 2/4/1991 II 2/20/1991 WISCONSIN ANALYTICAL & RESEARCH SERVICES LTD LUSOCHIMICA SPA BASF AKTIENGESELLSCHAFT GLAXO WELLCOME INC DETERMINATION OF BROMPHENIRAMINE IN HUMAN PLASMA BY GAS LIQUI IPRATROPIUM BROMIDE AS MFG. IN LOMAGNA (CO), ITALY LUPOLEN 5041 H AS MFG. IN WESSLING, REPUBLIC OF GERMANY PLASTIC PACKAGING COMPONENTS AS MFG. IN GREENVILLE, NC I A I I I A I A A A I III II III II II II II II II II III III 2/4/1991 2/15/1991 2/11/1991 2/15/1991 2/21/1991 2/5/1991 2/14/1991 2/18/1991 2/22/1991 2/1/1991 2/15/1991 2/15/1991 I I I III III II II 1/16/1991 1/16/1991 2/4/1991 2/5/1991 BASF AKTIENGESELLSCHAFT BASF AKTIENGESELLSCHAFT CALBIOCHEM-BEHRING CORP RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA VALSPAR KOLACK CORPORATION AG SIEGFRIED USA LLC LUDWIG HEUMANN AND CO GMBH ORGANICHEM CORP ARCHIMICA LTD SIEGFRIED LTD HELVOET PHARMA MARYLAND SIFAVITOR SRL IPSEN MANUFACTURING IRELAND LTD QUIMICA SINTETICA SA HELVOET PHARMA MARYLAND I I A III I II I 1/25/1991 1/31/1991 2/4/1991 1/30/1991 STATUS Type SUBMIT DATE A I I I I I I I I I I II II II II II II II II II II II II 1/22/1991 1/25/1991 1/24/1991 2/8/1991 1/22/1991 1/30/1991 1/28/1991 1/29/1991 1/30/1991 1/29/1991 1/28/1991 2/5/1991 HOLDER NIPPON KAYAKU CO LTD SUMIKA FINE CHEMICALS CO LTD MALLINCKRODT CHEMICAL INC STERLING DRUG INC SEPPIC HENKEL CORP UNICHEM LABORATORIES LTD PHARMAGLOBE LABS LTD DIOSYNTH BV PHARMECO LABS INC PENINSULA LABS ABBOTT LABS CHEM AND AGRICULTURAL PRODS DIV BASF AKTIENGESELLSCHAFT QP CORP KONGO CHEMICAL CO LTD RP SCHERER SUBJECT ETOPOSIDE AS MFG. IN TOKYO, JAPAN TRIPROLIDINE HYDROCHLORIDE AS MFG. IN THE GIFU, JAPAN NALTREXONE METHOBROMIDE AS MFG. IN ST. LOUIS, MISSOURI PLACEBO TABLETS TO MACH PRIMAQUINE PHOSPHATE TABLETS IN N.Y. INTERMEDIATE FOR MONTANIDE ISA 50 AS MFG. IN CASTRES, FRANCE DELIOS MEDIUM CHAIN TRIGLYCERIDES AS MFG. IN LAGRANGE, IL PYRIDOSTIGMINE BROMIDE AS MFG. IN BOMBAY, INDIA RANITIDINE HYDROCHLORIDE AS MFG. IN REXDALE, ONTARIO, CANADA STANOLONE AS MFG. IN THE NETHERLANDS 2-(2,6-DIOXO-3-PIPERIDINYL)1H-ISOINDOLE-1,3(2H)-DIONE IN CA VASOACTIVE INTESTINAL PEPTIDE AS MFG. IN BELMONT, CALIFORNIA RENAL KETO ACID PRODUCT AS MFG. IN NORTH CHICAGO, ILLINOIS NOVOLEN 1300 L AS MFG. IN WESSELING, GERMANY MANUFACTURING SITE IN SASHIMA-GUN, IBARAKI, JAPAN PHENIRAMINE MALEATE AS MFG. IN JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BEINHEIM, FRANCE. NOVOLEN 1300 H MANUFACTURED IN WESSELING, GERMANY. NOVOLEN 2500 HX MANUFACTURED IN WESSELING, GERMANY. DODECYL-B-D-MALTOSIDE AS MFG. IN LA JOLLA, CALIFORNIA ATENOLOL MANUFACTURED IN LATINA, ITALY. INTERIOR COATING J 3092 AS MFG. IN KALTBRUNN, SWITZERLAND VENLAFAXINE HYDROCHLORIDE AS MFG. IN PENNSVILLE, NEW JERSEY LAQUERED ALUMINUM FOIL PACKAGING MANUFACTURED IN GERMANY. PODOPHYLLOTOXIN AS MFG. IN HERLEV, DENMARK ETHYL-4-N(N-BUTYLAMINO) BENZOATE AS MFG. IN ENGLAND VENLAFAXINE HYDROCHLORIDE AS MFG. IN ZOFINGEN, SWITZERLAND CALCIUM LACTOBIONATE AS MFG. IN THANE, INDIA IPRATROPIUM BROMIDE MANUFACTURED IN MILAN, ITALY. SOMATULINE (BIM 23014C) AS MFG. IN DUBLIN, IRELAND FLUCONAZOLE AS MFG. IN MADRID, SPAIN RUBBER CLOSURE LZ412 AS MFG. IN SALISBURY, MARYLAND

4Q2012

LAWSON MARDON WHEATON PHARMATECH RUBBER CLOSURE B5310-55 GRAY MANUFACTURED IN SALISBURY, MARYLAND.

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4Q2012EXCEL DMF# 8982 I 8983 8984 I 8985 8986 8987 8988 8989 8990 8991 8992 8993 A 8994 8995 8996 8997 8998 8999 9000 9001 9002 I 9003 9004 I 9005 9006 9007 9008 9009 9010 9011 9012 9013 I 9014 9015 9016 9017 A A I I IV IV II II 3/13/1991 3/13/1991 3/12/1991 3/13/1991 FRESENIUS KABI DEUTSCHLAND GMBH NIPPON FINE CHEMICAL CO LTD TOMITA PHARMACEUTICAL CO LTD NOVARTIS PHARMACEUTICALS CORP A A A I I I A I IV II II II II IV II III I 3/7/1991 2/25/1991 3/7/1991 3/5/1991 3/14/1991 3/28/1991 2/25/1991 2/28/1991 3/13/1991 I III II 2/28/1991 2/28/1991 SPECIALTY PACKAGING PRODUCTS INC PERKIN ELMER LIFE AND ANALYTICAL SCIENCES INC NIPPON FINE CHEMICAL CO LTD BASF ORGAMOL PHARMA SOLUTIONS SA ISP CHEMICALS LLC BACHEM FEINCHEMIKALIEN AG EASTMAN CHEMICAL CO ROHM AND HAAS CO GEO SPECIALTY CHEMICALS PHILLIPS PLASTICS CORP DUPONT MERCK PHARMACEUTICAL CO I I I A I I A I I III II IV II II II III I 3/1/1991 2/22/1991 2/25/1991 3/1/1991 3/26/1991 3/4/1991 3/4/1991 3/1/1991 2/27/1991 DANIPHARM APS SPECIALTY PACKAGING PRODUCTS INC EURAND AMERICA INC NIPPON FINE CHEMICAL CO LTD MARINE BIO CO LTD DIOSYNTH BV NV ORGANON HUHTAMAKI FORCHHEIM KNOLL AG LUDWIGSHAFEN FACILITIES AND OPERATING PROCEDURES IN NIBE, DENMARK LPA-19 PUMP AS MFG. IN BRIDGEPORT, CT. AND EL PASO, TEXAS POTASSIUM CHLORIDE MICROCAPS COMPRESSIBLE AS MFG.-VANDALIA,OH I I I I I I I I II II II I II II IV II II 2/26/1991 2/25/1991 1/7/1991 1/7/1991 1/7/1991 2/27/1991 2/26/1991 2/28/1991 2/28/1991 I I II 2/18/1991 2/21/1991 STATUS Type SUBMIT DATE I 2/18/1991 HOLDER GRUPPO LEPETIT SPA SUB MERRELL DOW PHARMACEUTICALS INC BIOCHIMICA DEL SALENTO SPA FIRST SOUTHWEST PHARMACEUTICAL FACTORY NORDION INT INC ENZYMATIX LTD CHISSO CORP CHISSO CORP CHISSO CORP INDUSTRIE CHIMICHE ITALIANE SPA MATRIX PHARMACEUTICAL INC MATRIX PHARMACEUTICAL INC BAYER SCHERING PHARMA AG SUBJECT FACILITIES AND OPERATING PROCEDURES IN BRINDISI, ITALY FACILITIES AND OPERATING PROCEDURES IN BRINDISI, ITALY CIMETIDINE AS MFG. IN CHONGQING CITY, REPUBLIC OF CHINA INDIUM CHLORIDE (IN-111) AS MFG. IN KANATA, ONTARIO, CANADA 1,2-DIPALMITOYL-SN-GLYCEROL-3-PHOSPHOCOLINE DPPC AS MFG. UK CELLUFINE GC GEL FILTRATION CHROMATOGRAPHY MEDIA MFG. JAPAN FACILITIES AND OPERATING PROCEDURES IN MINAMAA, JAPAN CELLUFINE SULFATE AS MFG. IN MINAMAA, JAPAN TERFENADINE MANUFACTURED IN MILAN, ITALY. COLLAGEN IN SYRINGES AS MFG. IN MENLO PARK, CALIFORNIA 5-FU THERAPEUTIC IMPLANT AS MFG. IN MENLO PARK, CALIFORNIA

4Q2012

CIPROFLOXACIN (ESUB) AS MANUFACTURED IN WUPPERTAL, FEDERAL REPUBLIC OF GERMANY

PHOSPHOLIPID PGE (L-A-PHOSPHATIDYL GLYCEROL) AS MFG. IN HYOGO, JAPAN PROTAMINE SULFATE (BULK) AS MFG. IN KAMAISHI, JAPAN APOMORPHINE HYDROCHLORIDE AS MFG. IN OSS, THE NETHERLANDS GONADERELIN DIACETATE TETRAHYDRATE MANUFACTURED IN OSS, HOLLAND. HDPE FILM, QUALITY 24000, WHITE 71000 IN FORCHHEIM, GERMANY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN UETERSEN, GERMANY. PLP-20 PUMP MANUFACTURED IN BRIDGEPORT CONNECTICUT AND EL PASO, TEXSA. PHOSPHOROUS-32 AS MFG. IN NORTH BILLERICA, MASSACHUSETTS PHOSPHOLIPID DMPC AS MFG. IN HYOGO, JAPAN 4-CHLORBUTANAL SODIUM BISULPHATE ADDUCT MFG. IN SWITZERLAND SYNTHETIC PROCEDURE FOR MITOTANE MANUFACTURED IN COLUMBUS, OHIO. N-FMOC-L-LEUCINE SODIUM SALT MANUFACTURED IN BUBENDORF, SWITZERLAND. VITAMIN E TPGS AS MFG. IN ROCHESTER, NEW YORK AMBERLITE IRP-64 AS MFG. IN PHILADELPHIA, PENNSYLVANIA GLYCINE AS MFG. IN DEER PARK, TEXAS GENTLE HAIR ACTUATORS MANUFACTURED IN EAU CLAIRE, WISCONSIN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GENEVA, SWITZERLAND. EGG YOLK PHOSPHOLIPID (EYP) MFG. IN KUNGSANGEN & STOCKHOLM PHOSPHOLIPID DSPG (DISTEAROYL-L-A-PHOSPHATIDYL GLYCEROL) MAGALDRATE AS MFG. IN NARUTO-CITY AND TOKUSHIMA-CITY, JAPAN TESSALON DRUG SUBSTANCE AS MFG. IN SUMMIT, NEW JERSEY

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4Q2012EXCEL DMF# 9018 9019 9020 9021 9022 9023 I 9024 9025 9026 9027 9028 9029 9030 9031 9032 9033 9034 A 9035 9036 9037 9038 9039 I 9040 9041 9042 9043 9044 9045 I 9046 I 9047 9048 9049 9050 9051 9052 9053 9054 I I I I I I I A I II II II II IV II IV 4/9/1991 4/9/1991 4/3/1991 4/10/1991 4/11/1991 4/12/1991 4/11/1991 4/10/1991 SANKYO CO LTD SANKYO CO LTD UNITED GUARDIAN INC SUMIKA FINE CHEMICALS CO LTD CHISSO CORP GATTESFOSSE SA CARLBIOTECH LTD AS LYONDELLBASELL INDUSTRIES I 3/29/1991 SIEGFRIED CHEMICALS INC A I A A I III III II II II I 3/27/1991 4/5/1991 4/2/1991 4/4/1991 4/2/1991 4/9/1991 BOREALIS AG MOBIL CHEMICAL CO ISOCHEM SAS FERMION OY CHEMIE LINZ GES MBH SCIENCE LABORATORIES INC I I I I II III II II I 3/18/1991 3/27/1991 3/29/1991 3/29/1991 3/27/1991 I A A I I I I I I I II III II II II II II III II II IV 3/13/1991 3/12/1991 3/28/1991 3/25/1991 3/28/1991 3/25/1991 3/20/1991 3/18/1991 3/27/1991 3/27/1991 3/25/1991 STATUS Type SUBMIT DATE I I I I I I II V II III I 3/12/1991 3/15/1991 3/13/1991 3/8/1991 3/4/1991 3/11/1991 HOLDER FRESENIUS KABI CLAYTON L P SCICLONE PHARMACEUTICALS INC SIGMA F AND D DIV LTD INTEGRATED PLASTIC TECHNOLOGIES MERCK PHARMACEUTICAL MANUFACTURING DIV RAYLO CHEMICALS MONTEBELLO PACKAGING BIOINDUSTRIA FARMACEUTICI SPA AMERICAN BIO SYNTHETICS CORP JOHNSON MATTHEY INC CILAG CHEMIE AG GLUCONA BV B BRAUN CO FARMITALIA CARLO ERBA SPA FARMITALIA CARLO ERBA SPA AMCOL HEALTH AND BEAUTY SOLUTIONS INC ABBOTT LABS BRYCE CORP OMNICHEM NV PROCOS SPA NESTE CHEMICALS SUBJECT MCT LIPID EMULSION MANUFACTURED IN CLAYTON, NORTH CAROLINA. PRECLINICAL STUDIES FOR THYMOSIN ALPHA 1 INJECTION MYO-INOSITOL AS MFG. IN ST. LOUIS, MISSOURI POLYPROPYLENE CLOSURES AS MFG. IN HOLYOKE, MASSACHUSETTS FACILITIES AND OPERATING PROCEDURES IN NORTHUMBERLAND, UK DOBUTAMINE HYDROCHLORIDE AS MFG. IN EDMONTON, ALBERTA, CANADA COLLAPSIBLE ALUMINUM TUBES AS MFG. IN HAWKESBURY, ONTARIO INDAPAMIDE AS MFG. IN NOVI LIGURE, ITALY CAFFEINE AS MFG. IN MILWAUKEE, WISCONSIN DMP LACTATE MANUFACTURED IN WEST DEPTFORD, NEW JERSEY. PYRIDOSTIGMINE BROMIDE MFG. IN SCHAFFHAUSEN, SWITZERLAND MAGNESIUM GLUCONATE AS MFG. IN TER APELKANATAL, NETHERLANDS SMITHKLINE BEECHAM PHARMACEUTICALS FACILITIES AND OPERATING PROCEDURES IN TIANJIN, CHINA

4Q2012

DISPENSER SET 1 ML. AND 4 ML. MANUFACTURED IN MELSUNGEN, GERMANY. FCE 25913 (BAU) FINISHED DOSAGE FORM AS MFG. IN MILAN, ITALY FCE 25913 (BAU) ACTIVE DRUG SUBSTANCE AS MFG. IN MILAN, ITALY METHYL METHACRYLATE/ETHYLENEGLYCOL DIMETHACRYLATE COPOLYMER MICROSPONGE PRODUCT CODE E140.06 FENTANYL MANUFACTURED IN NORTH CHICAGO, ILLINOIS. FLEXIBLE PACKAGING LAMINATION MANUFACTURED IN MEMPHIS, TENNESSEE. PANCURONIUM BROMIDE MANUFACTURED IN BELGIUM. TERFENADINE AS MFG. IN CAMERI (NOVARA), ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BERINGEN, BELGIUM. POLYPROPYLENE PRODUCTS HD800P AND HE820P AS MFG IN BELGIUM BICOR OPPALYATE TWL AS MFG. IN SHAWNEE, OKLAHOMA FLAVOXATE HYDROCHLORIDE AS MFG. IN GENNEVILLERS, FRANCE ALPRAZOLAM AS MFG. IN ESPOO AND HANKO, FINLAND FIDOL, 3-(4-FLUORPHENYL)-1(METHLETHYL)-1H-INDOL IN AUSTRIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MINNEAPOLIS, MINNESOTA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TAIPEI, TAIWAN. FACILITIES AND OPERATING PROCEDURES IN HIRASUKA-SHI, JAPAN BULK CS-045 ORAL HYPOGLYCEMIC AS MFG. IN HIRASUKA-SHI, JAPAN IDOSENE SURGICAL SCRUB AS MFG. IN HAPPAUGE, NEW YORK CHLORPHENESIN CARBAMATE AS MFG. IN ANPACHIGUN, JAPAN CELLUFINE GH-25 AS MFG. IN MINAMAA, JAPAN GELEOL STEARATE 4000(STEARATE 4000 SD) AND GELOT 64(GELOT SD) DESMOPRESSIN ACETATE AS MFG. IN COPENHAGEN, DENMARK 1200 GRADE AND 1250 GRADE ALCOHOL AS MFG. IN TUSCOLA,ILLINOIS

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4Q2012EXCEL DMF# 9055 9056 9057 9058 A 9059 9060 9061 9062 I 9063 I 9064 9065 I 9066 I 9067 9068 9069 9070 9071 9072 9073 9074 9075 I 9076 I 9077 I 9078 9079 I 9080 I 9081 I 9082 9083 I 9084 9085 9086 I I I II III III 3/25/1991 4/30/1991 4/17/1991 QUIMICA SINTETICA S A CUSTOM PACK INC CEBAL I II I 4/15/1991 5/1/1991 II 4/30/1991 II 4/26/1991 I II I 4/20/1991 4/20/1991 I 4/26/1991 II 4/23/1991 CLARIANT LIFE SCIENCE MOLECULES UK LTD GUIDELINES ANALYTICAL LABORATORIES INC ATUL PRODUCTS LTD ATUL PRODUCTS LTD I I I A I A I A II II I II II III II II I 4/12/1991 4/12/1991 4/17/1991 3/29/1991 4/17/1991 4/19/1991 4/19/1991 4/19/1991 4/22/1991 KAWAKEN FINE CHEMICALS CO LTD KAWAKEN FINE CHEMICALS CO LTD AZIENDE CHIMICHE RIUNITE FINE CHEMICALS CORP PTY LTD SIEGFRIED AG AC FOLIEN GMBH GIST BROCADES ZACH SYSTEM SANOFI WINTHROP LTD. I 4/12/1991 A II II 3/25/1991 4/18/1991 QUIMICA SINTETICA SA INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA KAWAKEN FINE CHEMICALS CO LTD I 4/16/1991 ALMU SA I I I II II II I 4/17/1991 4/15/1991 4/15/1991 4/11/1991 STATUS Type SUBMIT DATE I I I II V II II 3/4/1991 4/9/1991 4/9/1991 4/5/1991 HOLDER ULTRADENT PRODUCTS INC INSTITUTE FOR CLINICAL PET INSTITUTE FOR CLINICAL PET SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL ROUSSEL LABORATORIES LTD ZAMBON GROUP SPA ESTEVE QUIMICA SA QUALIS INC SUBJECT 5% SANQUANARINE CHLORIDE (PERIOGARD) AS MFG. IN SANDY, UTAH CLINICAL AND PRECLINCAL DATA ON FLUDEOXYGLUCOSE F-18 INJECTION FLUDEOXYGLUCOSE F-18 INJECTION GEMFIBROZIL AS MFG. IN FIRENZE, ITALY PENTAMIDINE ISETHIONATE AS MFG. IN WILTSHIRE, ENGLAND DIFLUNISAL AS MFG. IN VICENZA, ITALY CARBIDOPA AS MFG. IN BARCELONA, SPAIN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DES MOINES, IOWA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ZENETA (MURCIA) SPAIN. INDAPAMIDE AS MFG. IN MADRID, SPAIN TERBUTALINE SULFATE AS MFG. IN CARONNO PERTUSELLA, ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KAWAGOE CITY, JAPAN. DIHYDROLYSERGIC ACID AS MFG. IN SAITAMA, JAPAN DIHYDROELYMOCLAVINE AS MFG. IN SAITAMA, JAPAN FACILITIES AND OPERATING PROCEDURES IN ANCONA, ITALY GLIPIZIDE AS MFG. IN CAPE PROVINCE, SOUTH AFRICA GEMFIBROZIL AS MFG. IN ZOFINGEN, SWITZERLAND PVC FILM AS MFG. IN MULLHEIM, GERMANY EXOMETHYLENE CEPH V SULFOXIDE ESTER AS MFG. IN NETHERLANDS MILNACIPRAN AS MFG. IN AVRILLE, FRANCE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MANCHESTER, ENGLAND. AMINOBENZOATE POTASSIUM AS MFG. IN SANDYCROFT, ENGLAND MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MIAMI, FLORIDA. CLIOQUINOL AS MFG. IN GUJARA, INDIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GUJARA, INDIA. RANITIDINE AS MFG. IN CHOGQING CITY, REPUBLIC OF CHINA

4Q2012

FIRST SOUTHWEST PHARMACEUTICAL FACTORY BRISTOL MYERS SQUIBB PHARMACEUTICAL TIPREDANE AS MFG. BY LINSON LTD./SWORDS IN DUBLIN, IRELAND RESEARCH INSTITUTE BASF AKTIENGESELLSCHAFT VITAMIN A ACETATE, 1.0 MIO I.U./GRAM AS MFG. IN GERMANY SOLCHEM ITALIANA SPA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MILAN, ITALY. FAMOTIDINE AS MFG. IN MADRID, SPAIN CUSTOM THERMOFORMING AND FOAM FABRICATION IN PENNSYLVANIA BLISTER FOIL AS MFG. IN BRIGNOUD, FRANCE

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4Q2012EXCEL DMF# 9087 9088 9089 9090 9091 I 9092 9093 9094 9095 9096 9097 I 9098 9099 9100 9101 9102 9103 9104 9105 I 9106 9107 I 9108 9109 9110 9111 I 9112 9113 9114 I 9115 9116 I 9117 9118 9119 9120 I I A I III II II I 5/7/1991 5/13/1991 5/13/1991 5/13/1991 NATIONAL WAX CO ARCH PHARMALABS LTD ARCH PHARMALABS LTD SEKHSARIA CHEMICALS PRIVATE LTD A II I 4/22/1991 5/7/1991 ESTEVE QUIMICA SA PHARMA TECH INDUSTRIES INC I I II II I 5/14/1991 4/30/1991 4/22/1991 YUKI GOSEI KOGYO CO LTD MERCK AG FINAF 92 SA I I I II II II I 5/6/1991 5/7/1991 5/6/1991 5/14/1991 FARMITALIA CARLO ERBA SPA MALLINCKRODT CHEMICAL INC SIEGFRIED AG YUKI GOSEI KOGYO CO LTD I II I 5/6/1991 5/6/1991 FARMITALIA CARLO ERBA SPA FARMITALIA CARLO ERBA SPA N I I N I I A II II II I 5/2/1991 4/30/1991 5/15/1991 4/3/1991 II II 4/30/1991 5/6/1991 A I I A I II II II II II I 5/1/1991 4/29/1991 5/3/1991 4/18/1991 5/1/1991 4/11/1991 STATUS Type SUBMIT DATE A I I I II I III III II 4/29/1991 4/29/1991 4/4/1991 5/1/1991 5/1/1991 HOLDER ABBVIE INC ABBOTT LABORATORIES LTD AT PLASTICS HEINKE TECHNOLOGY INC LEBSA LABORATORIOS ESPINOSY BOFILL SA LIFECORE BIOMEDICAL GANES CHEMICALS INC EASTMAN KODAK CO NORDION CANADA INC WHATMAN MERCK SHARP & DOHME RESEARCH LABS, DEVELOPMENT LABS NOT AN ASSIGNED NUMBER KERFOOT PHARMACEUTICALS HOECHST MARION ROUSSEL SA NOT AN ASSIGNED NUMBER SIPSY SIPSY SNC BASF PHARMACHEMIKALIEN GMBH CO KG VITA TECH INTERNATIONAL INC BUTOXOCORT PROPIONATE AS MFG. IN AVRILLE CEDEX, FRANCE AMIFOSTINE AS MFG. IN AVRILLE CEDEX, FRANCE XYLOMETAZOLINE HYDROCHLORIDE MFG. IN MINDEN, GERMANY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TUSTIN, CALIFORNIA. FCE 23884 ACTIVE DRUG SUBSTANCE AS MFG. IN MILAN, ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF FCE 23884 IN MILAN, ITALY. FCE 23884 0.20 AND 0.50 MG TABLETS MFG. IN MILAN, ITALY OXYMORPHONE HYDROCHLORIDE AS MFG. IN ST. LOUIS, MISSOURI METOPROLOL TARTRATE MANUFACTURED IN ZOFINGEN, SWITZERLAND. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF SULFADIAZINE SILVER IN JAPAN. SULFADIAZINE SILVER MFG. IN JOBAN, JAPAN 4-DIMETHYLAMINOPHENOL HYDROCHLORIDE AS MFG. SWITZERLAND MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TARRAGONA, SPAIN. SODIUM DICLOFENAC MANUFACTURED IN TARRAGONA, SPAIN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN UNION, MISSOURI. CEREPLAX 4628 WAX COATING MFG. IN SKOKIE, ILLINOIS PIROXICAM (ESUB) MANUFACTURED IN THANE, MAHARASHTRA, INDIA. IBUPROFEN MANUFACTURED IN THANE, MAHARSHTRA, INDIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN THANE, INDIA SUBJECT ISOFLURANE (ESUB) MANUFACTURED IN QUEENBOROUGH, KENT, ENGLAND. FACILITIES AND OPERATING PROCEDURES IN QUEENBOROUGH, ENGLAND PACKAGING MATERIALS A 910 AND A 720 MB MFG. IN CANADA PACKAGING MATERIAL FOR DISPOSABLE VAGINAL CREAM APPLICATOR ELGODIPINE HYDROCHLORIDE AS MFG. IN BARCELONA, SPAIN SODIUM HYALURONATE MANUFACTURED IN MINNEAPOLIS, MINNESOTA. ETHYL 4-(BUTYLAMINO) BENZOATE - CARLSTADT AND PENNSVILLE, NJ FLUORESCEIN MFG. IN ROCHESTER, NEW YORK STRONTIUM-82 AS MFG. IN VANCOUVER, B.C., CANADA D322 DIETHYLAMINOETHYL CELLULOSE MFG. IN KENT, ENGLAND MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HODDESDON, HERTFORD, UNITED KINGDOM. KETOPROFEN MANUFACTURED IN LANCANSHIRE, ENGLAND. HYDROXOCOBALAMIN BASE MANUFACTURED IN FRANCE.

4Q2012

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4Q2012EXCEL DMF# 9121 I 9122 I 9123 9124 9125 9126 9127 9128 9129 9130 9131 9132 9133 I 9134 9135 9136 9137 9138 9139 9140 9141 9142 9143 9144 9145 9146 9147 9148 I 9149 9150 I 9151 9152 I 9153 9154 I 9155 9156 A I IV II 6/10/1991 6/7/1991 ROQUETTE FRERES RASCHIG GMBH I III I 5/24/1991 6/4/1991 UNITED CLOSURES AND PLASTICS PLC GATTEFOSSE AG I II I 6/5/1991 5/21/1991 NIPPON FINE CHEMICAL COMPANY LTD DIACEL CHEMICAL INDUSTRIES LTD I II I 6/5/1991 6/3/1991 FINE CHEMICALS CORP LTD MICRA BIOTECHNOLOGIES INC I I A I I I I I I I I I A A III III II III III II II II IV II II III III II I 5/22/1991 5/15/1991 5/20/1991 5/22/1991 5/15/1991 5/29/1991 5/21/1991 5/16/1991 5/24/1991 5/31/1991 5/30/1991 5/23/1991 5/29/1991 5/31/1991 5/21/1991 CONSOLIDATED CONTAINER CO LLC BASF AKTIENGESELLSCHAFT GEDEON RICHTER USA INC CROWN CORK AND SEAL COMPANY INC UNION CAMP CORP FRONTIER SCIENTIFIC INC SCHERING AG INSTITUTE FOR CLINICAL PET DS INDUSTRIE APS ABBOTT LABS EGIS PHARMACEUTICALS MITSUI CHEMICALS INC BOREALIS AG FERRO PFANSTIEHL YUKI GOSEI KOGYO CO LTD N N N A A I I I A I III II II II III II II I 5/13/1991 5/20/1991 5/20/1991 5/15/1991 5/17/1991 5/9/1991 4/30/1991 5/20/1991 I 5/16/1991 STATUS Type SUBMIT DATE I 4/30/1991 HOLDER SUBJECT YUNG SHIN PHARMACEUTICAL INDUSTRIES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING CO LTD PROCEDURES IN TAIWAN, CHINA. PHARMACIA AND UPJOHN INC MANFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN JOHANNESHOV, SWEDEN. NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER STYROLUTION GMBH NV ORGANON DIOSYNTH BV PFANSTIEHL LABORATORIES INC HELVOET PHARMA MARYLAND NV ORGANON ONY INC ELDER PHARMACEUTICALS LTD LURAN 368 R MFG. IN LUDWIGSHAFEN, GERMANY BUTORPHANOL TARTRATE MFG. IN APELDOORN, THE NETHERLANDS ALPRAZOLAM MFG. IN AK APELDOORN, THE NETHERLANDS SUCROSE, N.F. (HIGH PURITY) MFG. IN WAUKEGAN, ILLINOIS

4Q2012

RUBBER CLOSURE R2502-50 TAN MANUFACTURED IN SALISBURY, MARYLAND. HEPARIN SODIUM (PEROXIDE PURIFICATION PROCESS)-OSS, NETHERLANDS INFASURF MFG. IN AMHERST, NEW YORK MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NEW BOMBAY, INDIA. CONTAINERS MANUFACTURED IN VERONA, PENNSYLVANIA NOVOLEN 1100 N MFG. IN WESSLING, REPUBLIC OF GERMANY NORGESTREL MANUFACTURED IN BUDAPEST, HUNGARY. PILFER PROOF CAP MANUFACTURED BY CROWN BENDER IN GERMANY. PAPER/LOW DENSITY POLYETHYLENE MFG. IN NORTH CAROLINA NPE6 DRUG SUBSTANCE MFG. IN LOGAN, UTAH ILOPROST MFG. IN BERLIN, FEDERAL REPUBLIC OF GERMANY F-18 FLUDEOXYGLUCOSE (MICHIGAN SYNTHESIS) ESTARAM T SUPPOSITORY BASES MFG. IN COPENHAGEN, DENMARK ARBUTAMINE MFG. IN NORTH, CHICAGO, ILLINOIS SULFAMETHOXAZOLE MFG. IN BUDAPEST, HUNGARY TPX MFG. IN YAMAGUCHI, JAPAN BORMED DM55PHARM AS MANUFACTURED IN BURGHAUSEN, GERMANY SODIUM GLUCONATE MFG. IN WAUKEGAN, ILLINOIS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF PROTAMINE SULFATE IN TOKYO, JAPAN. INDAPAMIDE MFG. IN CAPE PROVINCE, SOUTH AFRICA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FORT LEE, NEW JERSEY. PHOSPHOLOPID DMPG MFG. IN HYOGO, JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN AARI-CITY, JAPAN. X825 PLASTIC CLOSURE MATERIAL MFG. IN NORWICH, ENGLAND MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LUCERNE, SWITZERLAND. BETA CYCLODEXTRIN MFG. IN LESTREM, FRANCE 3-ACETYLPRYIDINE MFG. IN LUDWIGSHAFEN, GERMANY

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4Q2012EXCEL DMF# 9157 9158 9159 9160 9161 I 9162 I 9163 9164 9165 9166 9167 9168 9169 9170 9171 9172 9173 9174 9175 9176 9177 9178 9179 9180 9181 9182 9183 9184 I 9185 9186 I 9187 9188 9189 9190 9191 9192 9193 I I I I I A A II II II III II II I 6/17/1991 6/25/1991 6/14/1991 7/30/1991 6/17/1991 6/24/1991 6/25/1991 PFANSTIEHL LABORATORIES INC FERMION OY QUIMICA SINTETICA S A HELVOET PHARMA MARYLAND IRE AVANTI POLAR LIPIDS INC KNOLL PHARMA CHEMICALS I II I 6/14/1991 6/21/1991 QUIMICA SINTETICA S A PERIMMUNE INC I I I I A I I I A I I I I I I I A I I A I IV IV II II II I II II II II II III III III II I II III III III IV I 2/25/1991 2/25/1991 6/13/1991 4/4/1991 6/11/1991 6/13/1991 6/12/1991 6/12/1991 6/10/1991 6/14/1991 6/14/1991 5/23/1991 5/23/1991 5/23/1991 6/13/1991 6/17/1991 6/11/1991 6/11/1991 6/11/1991 6/11/1991 6/12/1991 6/25/1991 POLIOLES SA DE CV POLIOLES SA DE CV NORAMCO OF DELAWARE INC FERSINSA GIST BROCADES SA DE CV EXCELLA GMBH JB LABS ROMAN INDUSTRIES COMPANY LTD ROMAN INDUSTRIES COMPANY LTD ORIL INDUSTRIE BAYER AG BAYER AG COSTAR NUCLEPORE COSTAR NUCLEPORE COSTAR NUCLEPORE GIULINI CHEMIE GMBH VAN DEN BERGH FOODS CO ZACH SYSTEM SPARTECH PLASTICS SPARTECH PLASTICS AMPACET CORP ALZA CORP ABIC LTD POLYETHYLENE GLYCOLS (PEG'S) MFG. IN LERMA ESTADO DE MEXICO PROPYLENE GLYCOL (MPG) AND DYPROPYLENE GLYCOL IN MEXICO PERINDOPRIL ERBUMINE MANUFACTURED IN WILMINGTON, DELAWARE. 7-ADCA MANUFACTURED IN COAHUILA, MEXICO. BUSPIRONE HYDROCHLORIDE MANUFACTURED IN NURNBERG, GERMANY. FACILITY AND OPERATING PROCEDURES IN HOLLAND, MICHIGAN UROFOLLITROPIN MANUFACTURED IN KANAGAWA-KEN, JAPAN. MENOTROPINS MFG. IN KANAGAWA-KEN, JAPAN PERINDOPRIL ERBUMINE MFG. IN BOLBEC, FRANCE METRIFONATE DRUG SUBSTANCE MFG. IN GERMANY METRIFONATE DRUG PRODUCT MFG. IN GERMANY QMC CARTRIDGE MEDIA FILTERS MFG. IN PLEASANTON, CALIFORNIA QR2 CARTRIDGE FILTERS MFG. IN PLEASANTON, CALIFORNIA QS CARTRIDGE FILTERS MFG. IN PLEASANTON, CALIFORNIA DIHYDROXY ALUMINUM SODIUM CARBONATE - LUDWIGSHAFEN, GERMANY FACILITIES AND OPERATING PROCEDURES IN JOLIET, ILLINOIS 1,3 PROPANEDIOL 2 PHENYL MFG. IN AVRILLE CEDEX, FRANCE THERMOPLASTIC SHEET TYPE PES-HD-PES MFG. IN PORTAGE, WI THERMOPLASTIC SHEET TYPE PES-PP-PES MFG IN PORTAGE, WI 11246 BLUE-WHITE PEMB MFG. IN TARRYTOWN, NEW YORK GITS MFG. IN VACAVILLE AND MOUNTAIN VIEW, CALIFORNIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NETANYA, ISRAEL. MEFENAMIC ACID MFG. IN MADRID, SPAIN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF LAK CELLS. PODOPHYLLOTOXIN MFG. IN WAUKEGAN, ILLINOIS PRAZOSIN HYDROCHLORIDE MFG. IN ESPOO AND HANKO, FINLAND BUSPIRONE MFG. IN IN MADRID, SPAIN II 6/12/1991 STATUS Type SUBMIT DATE I A I I II II II II I 6/6/1991 5/3/1991 6/4/1991 6/10/1991 6/11/1991 HOLDER SUMITOMO CHEMICAL CO LTD ZACH SYSTEM SYNTHELABO BP PENNISULA LABORATORIES INC FARMHISPANIA SA SUBJECT TERAZOSIN HYDROCHLORIDE MFG. IN GIFU AND OSAKA, JAPAN 4-METHOXY-2,3,6-TRIMETHYLBENZALDEHYDE MFG. IN CEDEX, FRANCE ZOLPIDEM TARTRATE MANUFACTURED IN MOURENX, FRANCE. PEPTIDE E MFG. IN BELMONT, CALIFORNIA

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BARCELONA, SPAIN. PHARMACEUTICAL WORKS POLPHARMA S.A NIFEDIPINE MFG. IN STAROGARD GDANSKI, POLAND

RUBBER CLOSURE FORMULATION B5002-45 RED MANUFACTURD IN MARYLAND. SODIUM MOLYBDATE MO-99 (FISSON) PURIFICATION IN BELGIUM 1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE MFG. IN ALABAMA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NOTTINGHAM, ENGLAND.

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4Q2012EXCEL DMF# 9194 9195 9196 9197 9198 I 9199 9200 9201 9202 9203 9204 I 9205 A 9206 A 9207 9208 9209 9210 9211 9212 9213 9214 9215 9216 9217 9218 9219 9220 I 9221 9222 9223 9224 9225 I 9226 9227 I 9228 A II 7/11/1991 I I V 7/9/1991 6/10/1991 I I I I II I IV III II 7/3/1991 7/16/1991 6/26/1991 7/9/1991 6/28/1991 I I I I I I I I I I A I I II II II II II II II II III II III II II IV 7/1/1991 7/1/1991 7/1/1991 7/1/1991 7/1/1991 7/1/1991 6/25/1991 6/25/1991 7/3/1991 6/21/1991 5/31/1991 5/15/1991 7/3/1991 5/12/1991 CHISSO CORP CHISSO CORP CHISSO CORP CHISSO CORP CHISSO CORP CHISSO CORP NEN LIFE SCIENCE PRODUCTS EI DUPONT DE NEMOURS & CO 4P FOLIE FORCHHEIM GMBH NV ORGANON UNITED CLOSURES AND PLASTICS PLC OMNICHEM SA CIPLA LTD CAPSPHARMA ENTERPRISE LTD SCIENCE BASED INDUSTRIES CAMPUS EGIS PHARMACEUTICALS PUBLIC LTD CO CHEMIE LINZ AG GIVAUDAN ROURE CORP NESTE CHEMICALS VEGEFLORA EXTRACOES DO NORDESTE LTDA NESTE CHEMICALS NATIONAL INSTITUTES HEALTH NATIONAL INSTITUTE ALLERGY AND INFECTIOUS DISEASES UCB MANUFACTURING IRELAND LIMITED III 6/24/1991 SCHOTT DE MEXICO SA DE CV III 6/24/1991 SCHWEIZ SCHOTT AG I I A I I III II IV I I I 6/20/1991 6/26/1991 6/17/1991 6/28/1991 6/27/1991 6/24/1991 TRICON ORION CORP LTD FERMION BLANVER FARMOQUIMICA LTDA SOCHINAZ SA ASTA MEDICA AG LIBBY LABS STATUS Type SUBMIT DATE I I I A II I II III I 6/13/1991 6/13/1991 6/26/1991 6/26/1991 6/26/1991 HOLDER APPLIED BIOSYSTEMS APPLIED BIOSYSTEMS PERIMMUNE INC AMPACET CORP B P R L FINE CHEMICALS P LTD SUBJECT ISIS 1082 MFG. IN FOSTER CITY, CA. (TRANS. TO BIOL. 7/10/91) FACILITIES IN FOSTER CITY, CA. (TRANS. TO BIOLOGICS-7/10/91) ATENOLOL MFG. IN KARNATAKA, INDIA 11171 WHITE PE MB MFG. IN TARRYTOWN, NEW YORK MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KARNATAKA, INDIA. HOSTAPHAN RN 100 MFG. IN FREIBURG, REPUBLIC OF GERMANY TRIAZOLAM MANUFACTURED IN ESPOO AND HANKO, FINLAND. TABULOSE AND TABULOSE-FG MFG. IN COTIA, BRAZIL FACILITIES AND OPERATING PROCEDURES IN VIONNAZ, SWITZERLAND FACILITIES AND OPERATING PROCEDURES IN CARINTHIA, AUSTRIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BERKELEY, CALIFORNIA. PRIMARY PACKAGING MATERIAL (VIALS, AMPULS, SYRINGES, CARTRIDGES) MANUFACTURED IN ST. GALLEN SWITZERLAND PRIMARY PACKAGING MATERIAL (VIALS, AMPULS, SYRINGES, CARTRIDGES) MANUFACTURED IN VERA CRUZ MEXICO CM CELLUFINE C - 200 MFG. IN MINAA, JAPAN DEAE CELLUFINE A - 200 MANUFACTURED IN MINAA, JAPAN. CM CELLUFINE C - 500 MFG. IN MINAA, JAPAN CM CELLUFINE C - 40 MFG. IN MINAA, JAPAN DEAE CELLUFINE A - 800 MFG. IN MINAA, JAPAN DEAE CELLUFINE A - 500 MFG. IN MINAA, JAPAN YTTRIUM-90 (YTTRIUM CHLORIDE) AS MFG. IN MASSACHUSETTS RHENIUM-186 AS SODIUM PERRHENATE (NARE04) MFG. MASSACHUSETTS EUROPHAN FILM QUALITY 89014 MFG. IN FORCHHEIM GMBH PYRIDOSTIGMINE BROMIDE MFG. IN APELDOORN, THE NETHERLANDS CLICLOC CLOSURES MFG. IN NORWICH, ENGLAND NEFAZODONE II MFG. IN WETTERN, BELGIUM PODOPHYLLOTOXIN MFG. IN INDIA EMPTY HARD GELATIN CAPSULES MANUFACTURED IN JERUSALEM, ISRAEL. CAPTOPRIL MANUFACTURED IN BUDAPEST, HUNGARY. FACILITY IN LINZ, AUSTRIA FRAGRANCE PA-71038 MFG. IN CLIFTON, NEW JERSEY POLYPROPYLENE PRODUCT XB18 66MN MFG. IN PORVOO, FINLAND PILOCARPINE NITRATE MANUFACTURED IN PARNAIBA, BRAZIL. FACILITIES AND OPERATING PROCEDURES IN PORVOO, FINLAND ANTIVIRAL STUDY GROUP INFORMATION TO SUPPORT CLINICAL STUDIES

4Q2012

ISOSORBIDE DINITRATE DILUTED MFG IN SHANNON, IRELAND

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4Q2012EXCEL DMF# 9229 9230 9231 9232 9233 9234 I 9235 9236 9237 9238 9239 I 9240 9241 9242 9243 I 9244 9245 9246 9247 9248 9249 I 9250 9251 I 9252 9253 9254 9255 I 9256 9257 9258 9259 9260 9261 9262 9263 9264 A I A I I I I I A II II I II II II II II II 7/24/1991 7/26/1991 7/23/1991 7/23/1991 7/22/1991 7/26/1991 7/23/1991 7/30/1991 7/26/1991 I I I I III III V 7/19/1991 7/22/1991 9/6/1988 7/22/1991 I II II 6/19/1991 7/18/1991 CHEDOKE MCMASTER HOSP ORION CORPORATION FERMION OULU PLANT GRUPPO LEPETIT SPA HELVOET PHARMA MARYLAND 3M DRAXIMAGE DIV DRAXIS SPECIALTY PHARMACEUTICALS INC MILES INC MEDICHEM SA MERCKLE GMBH HOFFMANN LA ROCHE INC PHARMAGLOBE LABS LTD PROSTINEX CHEMSPEC CHEMICALS PRIVATE LTD NOF CORP ROHM AND HAAS CO I A I I I I III III III II I 7/15/1991 7/11/1991 7/10/1991 7/16/1991 7/3/1991 6/19/1991 KOS PHARMACEUTICALS INC AMPACET CORP BASF AKTIENGESELLSCHAFT AMPACET CORP SIGMA F AND D DIV LTD CHEDOKE MCMASTER HOSP I I I II II II I 7/10/1991 7/15/1991 7/16/1991 7/16/1991 BURROUGHS WELLCOME (INDIA) LTD MEDEA RESEARCH LABORATORIES INC SANDOZ PHARMA LTD HISAMITSU PHARMACEUTICAL CO INC A I A I II I II II I 7/2/1991 7/2/1991 7/2/1991 7/2/1991 7/10/1991 IPCA LABORATORIES LTD IPCA LABORATORIES LTD IPCA LABORATORIES LTD BDH PHARMACEUTICALS LTD GLAXO WELLCOME INC STATUS Type SUBMIT DATE A I A I I II II II II III I 7/9/1991 7/10/1991 7/11/1991 8/1/1991 7/29/1991 7/2/1991 HOLDER MDS NORDION WYCKOFF CHEMICAL CO INC BACHEM SA DIOSYNTH BV 3M PHARMS E MERCK (INDIA) LTD SUBJECT SODIUM IODIDE I-131 MFG. IN FLEURUS, BELGIUM SELEGILINE HYDROCHLORIDE MFG. IN SOUTH HAVEN, MICHIGAN CARBIDOPA MANUFACTURED IN VIONNAZ, SWITZERLAND. NOMEGESTROL ACETATE MFG. IN OSS, THE NETHERLANDS PHARMACEUTICAL GRADE TRANSFER ADHESIVE MFG. IN MINNESOTA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF CHLOROQUIN PHOSPATE IN INDORE, INDIA CHLOROQUINE PHOSPHATE MFG. IN INDORE, INDIA FACILITY FOR BULK DRUG PRODUCTION IN INDORE INDIA PROBENECID USP AS MFG. IN RATLAM, MADHYA PRADESH, INDIA IBUPROFEN BULK DRUG SUBSTANCES MFG. IN IN INDORE, INDIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BOMBAY, INDIA. TRIMETHOPRIM BULK DRUG PRODUCT MFG. IN BOMBAY, INDIA HYDROXYUREA MFG. IN PORT JEFFERSON STATION, NEW YORK TIZANIDINE HYDROCHLORIDE MFG IN BASLE, SWITZERLAND MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TOKYO, JAPAN. FACILITIES AND PROCEDURES IN HOLLYWOOD, FLORIDA AND AKRON,OHIO 11418-F WHITE HDPE MB MFG. IN TARRYTOWN, NEW YORK ULTRAPEK KR 4175, 4176, 4177 AND 4178 MFG.-LUDWIGSHAFEN, FRG 11912 WHITE PE MB MFG. IN TARRYTOWN, NEW YORK N-DODECYL B-D-MALTOSIDE, PRODUCT NO. D 4641 IN ST.LOUIS, MO. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HAMILTON, ONTARIO, CANADA. 18F 2-FLUORO-2-DEOXYGLUCOSE MFG. IN HAMILTON, ONTARIO, CANADA DEXMEDETOMIDINE MFG IN OULU, FINLAND FACILITIES AND PROCEDURES IN GERENZANO (VARESE), ITALY RUBBER CLOSURE FORMULATION B-5001-55 PEARL GRAY-SALISBURY,MD SCOTCHPAK BRAND HEAT SEALABLE POLYESTER FILM NO. 113 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KIRKLAND, QUEBEC, CANADA. PENTEX HUMAN TRANSFERRIN, IRON SAURATED MFG. IN KANKAKEE, IL MEXILETINE HYDROCHLORIDE MFG. IN GERONA, SPAIN FACILITIES AND PROCEDURES IN BLAUBEUREN, GERMANY FLUCYTOSINE CAPSULES AND MACHING PLACEBO MFG. IN NEW JERSEY LINOLENIC ACID MFG. IN WINDSOR, NOVA SCOTIA, CANADA GLIPIZIDE MFG. IN VILLANTERIO (PAVIA), ITALY GUAIFENESIN MFG. IN BOMBAY, INDIA DIPALMITOYL PHOSPHATIDYL CHOLINE (DPPC) MFG. IN HYOGO, JAPAN

4Q2012

AMBERLITE IRP-88 POLACRILIN POTASSIUM NF AS MANUFACTURED IN CHAUNY, FRANCE

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4Q2012EXCEL DMF# 9265 I 9266 9267 9268 9269 9270 9271 9272 9273 I 9274 9275 9276 9277 9278 9279 9280 9281 9282 9283 9284 9285 9286 9287 9288 9289 9290 9291 I 9292 9293 9294 A 9295 I 9296 9297 I 9298 I 9299 9300 I A II III 8/21/1991 8/14/1991 PENINSULA LABS EXXONMOBIL CHEMICAL CANADA I 8/20/1991 KATSURA CHEMICAL CO LTD N I 8/20/1991 NOT AN ASSIGNED NUMBER SHIONOGI AND CO LTD MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KANEGASAKI, JAPAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN YAMAGATA, JAPAN. SECRETIN (PORCINE) MANUFACTURED IN BELMONT, CALIFORNIA. III 8/21/1991 MEGAS BEAUTY CARE INC I I II III II 8/2/1991 8/2/1991 8/20/1991 I A I I A I A I I I A A I I I A I I II II II II I II II II II II II III I II II IV II 8/1/1991 8/5/1991 8/9/1991 8/6/1991 8/9/1991 8/7/1991 8/7/1991 8/7/1991 8/13/1991 8/13/1991 8/12/1991 8/12/1991 8/8/1991 8/16/1991 8/13/1991 8/7/1991 8/15/1991 8/27/1991 PENN PHARMACEUTICALS DIPHARMA FRANCIS SRL PENINSULA LABS PHARMECO LABS INC EMBIO LTD E MERCK E MERCK GLOBE ORGANICS LTD FINE CHEMICALS CORPORATION ASAHI OPTICAL CO LTD AVANTI POLAR LIPIDS INC AVANTI POLAR LIPIDS INC SPARTECH PLASTICS AESCULAPIUS-PHARMA SA PHARMAGLOBE LABS LTD BAYER PHARMA AG NUTRI LITE PRODS INC SHANGHAI BIOCHEMICAL AND PHARMACEUTICAL LABORATORIES PHARMAGLOBE LABS LTD SPARTECH PLASTICS I A A I A I I II II II II II III II I 7/30/1991 7/31/1991 7/17/1991 7/31/1991 8/5/1991 6/4/1991 8/1/1991 8/5/1991 STATUS Type SUBMIT DATE II 7/31/1991 HOLDER CHEIL FOODS AND CHEMICALS INC PHARMACEUTICAL DIV ABBOTT LABORATORIES NORDION CANADA INC ZACH SYSTEM FARMHISPANIA SA MEDICHEM SA HEAT SEAL PACKAGING BPRL FINE CHEMICALS PRIVATE LTD STRATHMANN BIOTECH HANOVER SUBJECT 7-AMINOCEPHALOSPORANIC ACID BULK INTERMEDIATE MFG. IN KOREA 9-(S)-ERYTHROMYCYLAMINE MFG. IN NORTH CHICAGO, ILLINOIS YTTRIUM-90 CHLORIDE RADIOCHEMICAL MFG. IN CANADA FELBAMATE MFG. IN AVRILLE CEDEX, FRANCE CAPTOPRIL MFG. IN BARCELONA, SPAIN ETIDRONATE DISODIUM MFG. IN CELRA (GERONA), SPAIN FOILGUARD # W***BF10V MFG. IN QUEBEC, CANADA NIFEDIPINE BULK DRUG SUBSTANCE MFG. IN BANGALORE, INDIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HANNOVER, GERMANY. FACILITIES AND OPERATING PROCEDURES IN TREDEGAR, ENGLAND SELEGILINE HYDROCHLORIDE MFG. IN MILAN, ITALY ARG-9-ARG(RMP-7 DRUG SUBSTANCE) MFG. IN BELMONT, CALIFORNIA DIPIVEFRIN MFG. IN SIMI VALLEY, CALIFORNIA L-EPHEDRINE HYDROCHLORIDE MFG. IN MAHARASHTRA, INDIA

4Q2012

FACILITIES AND PROCEDURES IN DARMSTADT, GERMANY FOR SODIUM FLUORIDE SODIUM FLUORIDE MFG. IN DARMSTADT, GERMANY 1,1 METHYLAMINO METHYLTHIO 2-NITROTHENE AS MFG. IN INDIA FLUPHENAZINE ENANTHATE MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA. PENTAX HYDROXYAPAITE MFG. IN TOKYO, JAPAN 1,2-DIMYRISTOYL-SN-GLYCERO-3[PHOSPHO-RAC-(1-GLYCEROL)] ALABAM CHOLESTEROL MFG. IN ALABASTER, ALABAMA THERMOPLASTIC SHEET TYPE PP SHEET MFG. IN PORTAGE, WISCONSIN FACILITIES AND PROCEDURES IN MEZZOVICO, SWITZERLAND LINOLEIC ACID MFG. IN WINDSOR, NOVA SCOTIA, CANADA AZELAIC ACID MFG. IN BERLIN, GERMANY CALCIUM CARBONATE GRANULAR L13-075 MFG. IN LAKEVIEW, CA. UROKINASE MFG. IN SHANGHAI, CHINA TERFENADINE MFG. IN REXDALE, ONTARIO, CANADA HDPE PLASTIC SHEET MFG. IN PORTAGE, WISCONSIN

PHARMACEUTICAL WORKS POLPHARMA SA METRONIDAZOLE MFG. IN GDANSKI, POLAND RAYON AND COTTON BOTTLE FILLING MATERIAL MANUFACTURED IN POMFRET, CONNECTICUT.

ESCORENE POLYETHYLENE MANUFACTURED IN SARNIA, ONTARIO, CANADA. Page

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4Q2012EXCEL DMF# 9301 I 9302 I 9303 9304 9305 9306 9307 9308 9309 9310 9311 9312 9313 I 9314 I 9315 9316 9317 9318 I 9319 9320 I 9321 9322 9323 9324 9325 I 9326 I 9327 9328 9329 9330 9331 I 9332 9333 9334 I I I II II III 9/5/1991 9/5/1991 9/10/1991 I I I I III III II III I 9/6/1991 9/6/1991 9/4/1991 9/6/1991 9/5/1991 AMPACET CORP AMPACET CORP BACHEM FEINCHEMIKALIEN AG LEIDEL CORP I 9/3/1991 ALPS PHARMACEUTICAL IND CO LTD I I A I III II IV I I 9/3/1991 9/3/1991 9/5/1991 9/5/1991 9/3/1991 OWENS ILLINOIS INC THATCHER CHEMICAL COMPANY EASTMAN CHEMICAL CO SAUTER LABORATORIES LTD ALPS PHARMACEUTICAL IND CO LTD A III II 8/26/1991 8/30/1991 WATSON STANDARD CO BIOSPECIA LTD I I I III III II I 8/27/1991 8/27/1991 9/2/1991 9/4/1991 BASF AKTIENGESELLSCHAFT BASF AKTIENGESELLSCHAFT SUMIKA FINE CHEMICALS CO LTD TILLOTTS PHARMA AG I 8/30/1991 I A I I I I I I I I II II I II II II II II II II I 8/23/1991 8/26/1991 8/1/1991 8/26/1991 8/22/1991 8/29/1991 8/29/1991 8/29/1991 8/29/1991 8/30/1991 8/27/1991 CYGNUS THERAPEUTIC SYSTEMS BEST MEDICAL BELGIUM SA XTTRIUM LABS INC DOW CHEMICAL CO MICHIGAN DIV PFIZER INC CHISSO CORP CHISSO CORP CHISSO CORP CHISSO CORP CYANAMID UK LTD SHANGHAI BIOCHEMICAL AND PHARMACEUTICAL LABORATORIES REXAM CLOSURES I 8/16/1991 ISHIHARA SANGYO KAISHA LTD STATUS Type SUBMIT DATE II 8/16/1991 HOLDER ISHIHARA SANGYO KAISHA LTD SUBJECT

4Q2012

QUINUCLIDINE HYDROCHLORIDE HEMIHYDRATE MANUFACTURED IN YOKKAICHI, JAPAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN YOKKAICHI CITY, JAPAN. DEXMEDETOMIDINE TRANSDERMAL SYSTEM (DEXMED TX) REDWOOD CITY, CA. XENON XE-133 MFG. IN FRANCE, BELGIUM AND THE NETHERLANDS FACILITIES FOR THE MANUFACTURING OF ANTIMICROBIAL PRODUCTS AMINOGUANIDINE HYDROCHLORIDE MANUFACTURED IN MIDLAND, MICHIGAN. PREDNISOLONE SODIUM PHOSPHATE MFG. IN KALAMAZOO, MICHIGAN OCTYL-CELLUFINE HYDROPHOBIC INTERACTION CHROMATOGRAPHY MEDIA PHENYL-CELLUFINE HYDROPHOBIC INTERACTION CHROMATOGRAPHY MEDIA FORMYL-CELLUFINE AN AFFINITY CHROMATOGRAPHY MEDIA MFG. JAPAN HYDROPHOBIC INTERACTION CHROMATOGRAPHY MEDIA MANUFACTURD IN JAPAN. PROPRANOLOL HYDROCHLORIDE MFG. IN GOSSPORT, HANTS, ENGLAND MANUFACTURING FACILITIES FOR CHORIONIC GONADOTROPIN IN CHINA MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN EVANSVILLE AND PRINCETON, INDIANA POLYSTYROL 436C MFG. IN LUDWIGSHAFEN, GERMANY ULTRAFORM W2320 007 MANUFACTURED IN LUDWIGSHAFEN, GERMANY. NIFEDIPINE MANUFACTURED IN OKAYAMA, JAPAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ZIEFEN, SWITZERLAND. JVHS-157-1 VINYL ACRYLIC HEAT SEAL COATING, MANUFACTURED IN HARWICK, PA MENOTROPIN MANUFACTURED BY ANACLIN LIMITED IN SITTINGBOURNE, KENT, UNITED KINGDOM. THERMOPLASTIC CLOSURES AND PACKAGING MANUFACTURED IN CONSTANTINE, MI HEXACHLOROPHENE SOAP SOLUTION MANUFACTURED IN SALT LAKE CITY, UTAH. EASTMAN CELLULOSE ACETATE (CA-398-10NF) FACILITIES AND OPERATING PROCEDURES IN GENEVA, SWITZERLAND MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KAMINO, JAPAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MUKAIMACHI, JAPAN. 10358-F SLIP PE MB MFG. IN TARRYTOWN, NEW YORK 10477-F ANTIBLOCK PE MB MFG. IN TARRYTOWN, NEW YORK H-LEU-LEU-OME HYDROCHLORIDE MFG. IN BUBENDORF, SWITZERLAND INJECTION MOLDED PRODUCTS MFG. IN FARMINGDALE, NEW YORK

GEN THERAPEUTICA VERTRIEBS GMBH AND FACILITIES AND OPERATING PROCEDURES IN BAD ZWISCHENAHN,GERMANY CO BOEHRINGEER INGELHEIM PHARMA KG PILOCARPINE HYDROCHLORIDE MFG. IN BRAZIL BY MERCK/VEGETEX TECHNOCHEMIE GMBH HELVOET PHARMA MARYLAND METHOXYCARBONYL-METHYLENE-TRIPHENYL-PHOSPHORANEYLID-ESTER RUBBER FORMULATION B5310-55 BLACK MFG. IN SALISBURY,MARYLAND

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4Q2012EXCEL DMF# 9335 9336 I 9337 9338 I 9339 9340 9341 9342 9343 9344 9345 9346 9347 9348 9349 9350 9351 A 9352 9353 9354 9355 9356 I 9357 9358 I 9359 9360 9361 9362 9363 I 9364 9365 9366 9367 9368 I A I I I II II II II II 10/1/1991 9/30/1991 10/2/1991 10/3/1991 10/2/1991 EGIS PHARMACEUTICALS TAKEDA PHARMACEUTICAL CO LTD PENICK CORP REGIS CHEM CO PENICK CORP A I I A II II III IV I 9/23/1991 10/2/1991 9/25/1991 8/27/1991 9/7/1991 I I II 9/20/1991 9/26/1991 I I I I II III III II II 9/16/1991 9/18/1991 9/24/1991 9/27/1991 10/1/1991 A I I I I I I I I I I I IV IV IV II II II III I I II I IV II 9/10/1991 9/10/1991 9/10/1991 8/31/1991 8/31/1991 9/16/1991 9/18/1991 9/5/1991 9/19/1991 9/19/1991 9/19/1991 9/18/1991 9/6/1991 I III I 9/9/1991 9/6/1991 STATUS Type SUBMIT DATE I II II 9/6/1991 9/6/1991 HOLDER ISOCHEM SA LABORATOIRE AGUETTANT PARC SCIENTIFIC TONY GARNIER RUE ALEXANDER FLEMMING HELVOET PHARMA MARYLAND LABORATOIRE AGUETTANT PARC SCIENTIFIC TONY GARNIER RUE ALEXANDER FLEMMING SUBJECT 1,4-DITHIA-7-AZASPIRO[4,4]NONANE-8-(S)CARBOXYLIC ACID-HYDROBR APOMORPHINE MFG. IN LYON, FRANCE

4Q2012

RUBBER FORMULATION B5011-55 BLACK MFG. IN SALISBURY,MARYLAND FACILITIES AND PROCEDURES FOR THE MFG. OF APOMORPHINE, FRANCE

HENRY H OTTENS MANUFACTURING CO INC SPRAY DRIED ARTIFICIAL VANILLA CREAM FLAVOR S-208,PENNSYLVANI HENRY H OTTENS MANUFACTURING CO INC POWDERED NATURAL/ARTIFICAL LEMON JUICE FLAVOR #4968 IN PENNSY HENRY H OTTENS MANUFACTURING CO INC ARTIFICIAL CHERRY RASPBERRY FLAVOR #5091(ALCOHOL FREE) FINE CHEMICALS CORPORATION FINE CHEMICALS CORPORATION WHATMAN FUJI PHOTO FILM CO LTD TAIHO PHARMACEUTICAL CO INC GUJARAT DRUGS AND CHEMICALS LTD INFAR INDIA LTD AMUCHINA SPA GATTESFOSSE SA BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG GANES CHEMICALS INC PUBLIC STOCK CORPORATION OYJ HELVOET PHARMA MARYLAND AMICON DIV WR GRACE AND CO SHANGHAI BIOCHEMICAL AND PHARMACEUTICAL LABORATORIES HIGHLAND PACKAGING CO DAINIPPON INK AND CHEMICAL INC BIOCHEMICAL DIV SA AJINOMOTO OMNICHEM NV CHINA CHEMICAL SYNTHESIS IND CO LTD UNITED STATES COTTON INC BLANVER FARMOQUIMICA LTDA YUKI GOSEI KOGYO CO LTD TRIAZOLAM MFG. IN CAPE PROVINCE, SOUTH AFRICA ALPRAZOLAM MFG. IN CAPE PROVINCE, SOUTH AFRICA SODIUM CELLULOSE PHOSPHATE MFG. IN SPRINGFIELD MILL, ENGLAND ASTRO PORE PSM CARTRIDGE MFG. IN MINAMIASHIGARA CITY, JAPAN FACILITIES AND PROCEDURES FOR TAZOBACTAM BULK DRUG FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES - INDIA METOCLOPRAMIDE AND ITS RELATED HYDROCHLORIDE SALT MFG. INDIA FACILITY FOR THE MFG. OF AMUCHINA 10% IN CASELLA(GENOVA) ITALY SUPPOCIRE P SERIES EXCIPIENTS MFG. IN SAINT-PRIEST FRANCE HYOSCYAMINE SULFATE MFG. IN INGELHEIM, GERMANY FELBAMATE MFG. IN CARLSTADT AND PENNSVILLE, NEW JERSEY NASAL ADAPTER MFG. IN NURMIJARVI, FINLAND RUBBER FORMULATION N4003-45 RED MFG. IN SALISBURY, MARYLAND AMICON MATRIX SILICA REVERSED PHASE CHROMATOGRAPHY MEDIA HUMAN CHORIONIC GONADOTROPIN MFG. IN SHANGHAI, CHINA FACILITY IN BRANCHBURG TOWNSHIP, NEW JERSEY PANTETHINE MFG. IN IBARAGI-KEN, JAPAN BY DAINIPPON INK 6-MERCAPTOPURINE MFG. IN WETTERN, BELGIUM NORFLOXACIN MFG. IN TAIWAN, THE REPUBLIC OF CHINA 100% COTTON COIL MFG. IN RIO RANCHO, NEW MEXICO SOLUTAB CROSCARMELLOSE SODIUM MFG. IN ITAPEVI - SP - BRAZIL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF ISONAZID IN JOBAN FACTORY, IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN. PROCHLORPERAZINE MALEATE MFG. IN BUDAPEST, HUNGARY TAP-144-SR (3M) (22.5MG.) MANUFACTURED IN OSAKA AND FUJISAWA, JAPAN. CODEINE MFG. IN NEWARK, NEW JERSEY 4'-CARBETHOXYPHENYL-4-GUANIDINOBENZOATE HCL MFG. ILLINOIS CODEINE SULFATE MFG. IN NEWARK, NEW JERSEY

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4Q2012EXCEL DMF# 9369 9370 9371 9372 I 9373 9374 I 9375 I 9376 9377 9378 9379 9380 9381 I 9382 9383 9384 9385 9386 9387 9388 9389 9390 9391 9392 9393 I 9394 9395 9396 9397 9398 9399 9400 I 9401 9402 9403 9404 A I I I III I IV I 11/5/1991 11/5/1991 10/21/1991 10/21/1991 I I I I I A III III I I III II II 10/21/1991 10/21/1991 10/18/1991 11/5/1991 11/1/1991 10/31/1991 11/1/1991 CREST FLEXIBLE PACKAGING LTD CREST FLEXIBLE PACKAGING LTD TORAY INDUSTRIES INC CHEMAGIS LTD SOCIETE ALSACIENE D' ALUMINUM JOHNSON MATTHEY INC MALLADI DRUGS AND PHARMACEUTICALS LTD BESPAK DIV CONSORT MEDICAL PLC BIOKINE TECHNOLOGY LTD CERESTAR USA INC AMERICAN MAIZE-PRODUCTS COMPANY A I A A A I I I I I I II II II IV II II I I III III III II 10/23/1991 10/24/1991 10/24/1991 10/24/1991 10/24/1991 10/25/1991 10/28/1991 10/16/1991 10/25/1991 9/24/1991 9/24/1991 10/18/1991 SANOFI CHIMIE TAENAKA KOGYO CO LTD TAENAKA KOGYO CO LTD DOW CHEMICAL CO MALLINCKRODT INC WEST GRAND CORP SYNPAC CHEMICALS LTD YONEYAMA YAKUHIN KOGYO CO LTD BASELL POLIOLEFINE ITALIA SPA BASF AKTIENGESELLSCHAFT BASF AKTIENGESELLSCHAFT DAICEL CHEMICAL INDUSTRIES LTD A I I A I II III III III II I 10/9/1991 10/8/1991 10/8/1991 10/10/1991 10/18/1991 10/2/1991 CAMBREX PROFARMACO MILANO SRL ALUMINUM COMPANY OF AMERICA ALUMINUM COMPANY OF AMERICA JAPAN GLASS INDUSTRY CO LTD DIASPA BLIS TECH CORP I 10/14/1991 I II II 10/7/1991 10/4/1991 STATUS Type SUBMIT DATE I I I II III II I 9/30/1991 10/7/1991 10/8/1991 10/7/1991 HOLDER SUMIKA FINE CHEMICALS CO LTD HEAT SEAL PACKAGING DIOSYNTH BV HARIMA FACTORY OF TEIKOKU CHEMICAL INDUSTRIES NAGASE FINE CHEMICALS LTD SYNTEX PHARMACEUTICALS INTERNATIONAL LTD RESOLUTION CHEMICALS LTD SUBJECT DOBUTAMINE HYDROCHLORIDE MANUFACTURED IN ANPACHIGUN, JAPAN. FOILGUARD #W***LP150V MFG. IN VAUDREUIL, QUEBEC, CANADA UROFOLLITROPHIN MFG. IN OSS AND BOXTEL, THE NETHERLANDS FACILITIES AND OPERATING PROCEDURES IN OSAKA, JAPAN S-(+)-2-(4`-ISOBUTYLPHENYL) PROPIONIC ACID (S-(+)-IBUPROFEN AMIPRILOSE HYDROCHLORIDE MFG. IN FREEPORT, BAHAMA ISLAND

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF AZATHIPRINE UPS MANUFACTURED BY MITCHELL COTTS CHEMICALS IN WEDGEWOOD WAY, ENGLAND. ACEBUTOLOL HYDROCHLORIDE MFG. IN MILAN, ITALY PHAR 9101 MFG. IN PITTSBURGH, PENNSYLVANIA PHAR 9100 MFG. IN PITTSBURGH, PENNSYLVANIA GLASS AMPULES, VIALS AND CARTRIDGES MFG. IN SHIZUOKA, JAPAN DEMECLOCYCLINE HYDROCHLORIDE MFG. IN MILAN, ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FAIRFIELD, NEW JERSEY. ACEBUTOLOL HYDROCHLORIDE MFG. IN VITRY, FRANCE L-TYROSINE MFG. IN THE MOBARA PLANT, JAPAN L-GLUTAMIC ACID MANUFACTURED IN MOBARA, JAPAN. CARBOWAX SENTRY METHOXYPOLYETHYLENE GLYCOL MFG. NEW YORK DESMOPRESSIN (ESUB) MANUFACTURED IN ST. LOUIS, MISSOURI THEOPHYLLINE MFG. IN MILWAUKEE, WISCONSIN FACILITIES AND OPERATING PROCEDURES IN CAMBOIS, ENGLAND FACILITIES AND OPERATING PROCEDURES A THE MIKUNI PLANT LUPOLEN 6031 M MFG. IN WESSLING, GERMANY NOVOLEN 3204 PCX MFG. IN E-TARRAGONA, SPAIN NOVOLEN 3200 H MFG. IN E-TARRAGONA, SPAIN N-{1-(S)-ETHOXYCARBONYL-3-PHENYLPROPYL}-(S)-ALANINE MANUFACTURED IN NIGATA, JAPAN. SACCHET OVERWRAP MFG. IN GILLINGHAM, KENT, ENGLAND BLISTER PACK PEELABLE LIDDING MATERIAL MFG. IN KENT, ENGLAND FACILITIES FOR THE MFG. OF BERAPROST SODIUM IN NAGOYA, JAPAN MANUFACTURING SITE FOR PENTOXIFYLLINE MFG. IN BEER SHEVA, ISRAEL DRUG PHARMACEUTICAL BLISTER MFG.IN SELESTA CEDEX, FRANCE SUFENTANIL CITRATE (GENERIC) MANUFACTURED IN WEST DEPTFORD, NEW JERSEY. PSEUDOEPHEDRINE BASE MFG. IN THEIR PLANT LOCATED IN TAMILNADU, INDIA BESPAK BK 681 VALVE MFG. IN NORFOLK, ENGLAND FACILITIES FOR THE MFG. OF GLUCOSAMINYLMURAMYL PEPTIDES BETA-CYCLODEXTRIN MFG. IN HAMMOND, INDIANA FACILITIES AND OPERATING PROCEDURES IN HAMMOND, INDIANA

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4Q2012EXCEL DMF# 9405 9406 9407 9408 A 9409 9410 9411 9412 9413 9414 9415 I 9416 9417 9418 9419 9420 9421 9422 9423 9424 9425 9426 9427 I 9428 A 9429 A 9430 9431 9432 A 9433 9434 9435 I 9436 I 9437 9438 A I II II 12/2/1991 11/15/1991 II 10/28/1991 I I II II II 11/27/1991 11/25/1991 11/14/1991 JUZEN CHEMICAL CO., LTD. GANES CHEMICALS INC A A II II II 12/3/1991 11/1/1991 11/1/1991 LUSOCHIMICA SPA MEISSNER FILTRATION PRODUCTS INC MEISSNER FILTRATION PRODUCTS INC IV 11/1/1991 WILD FLAVORS INC V 12/2/1991 I I A I A I I I I I I I II II II IV II II III III I IV I 11/21/1991 11/15/1991 11/22/1991 11/25/1991 11/22/1991 10/22/1991 11/29/1991 11/21/1991 11/21/1991 11/25/1991 11/27/1991 11/8/1991 I I I I I I III I II II I II II 11/5/1991 11/5/1991 11/15/1991 11/15/1991 11/20/1991 11/20/1991 11/14/1991 ROLLPRINT PACKAGING PRODUCTS INC BIRCHWOOD LABORATORIES INC BIO RAD LABORATORIES INC BACHEM FEINCHEMIKALIEN AG H LUNDBECK & CO AS H LUNDBECK & CO AS INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA SQUIBB MANUFACTURING INC ALDRICH CHEMICAL COMPANY INC CMIC CMO CO LTD KYOWA HAKKO KOGYO CO LTD ROQUETTE FRERES ABBOTT LABS TANABE SEIYAKU CO LTD CREST FLEXIBLE PACKAGING LTD CREST FLEXIBLE PACKAGING LTD CARBOGEN LABORATORIES AG AQUALON CO PROMETIC BIOSCIENCES LIMITED STATUS Type SUBMIT DATE I I A II II III II 11/8/1991 11/14/1991 11/19/1991 11/11/1991 HOLDER MAY AND BAKER LTD SIFAVITOR SRL KAITO CHEMICAL INDUSTRY CO LTD SANDOZ GMBH SUBJECT PROMETHAZINE HYDROCHLORIDE MFG. IN DAGENHAM, ESSEX, ENGLAND METRONIDAZOLE BENZOATE MFG. IN MILAN, ITALY PORTION PACK A, B, AND C MFG. IN NODA (CHIBA) JAPAN

4Q2012

PYCA.HI (PYRIDINIUM-7-AMINOCEPHALOSPORANIC ACID HYDROIODIDE) MFG. IN KUNDL, TYROL, AUSTRIA RPP #36-1054 PACKAGING MATERIAL MFG. IN ADDISON, ILLINOIS FACILITY IN EDEN PRAIRIE, MINNESOTA BIO-GEL HTP (HYDROXYAPATITE) MANUFACTURED IN RICHMOND, CALIFORNIA. AC-ARG-PRO-ASP-PRO-PHE-NH2 CITRATE MFG. IN BUBENDORF, SWITZERLAND FACILITY IN NYKOBING SJ., DENMARK SERTINDOLE BULK DRUG SUBSTANCE MFG. IN NYKOBING SJ., DENMARK TERFENADINE MFG. IN CARONNO, PERTUSELLA (VA), ITALY FACILITIES FOR THE MFG. OF SEMISOLIDS IN HUMACAO, PUERTO RICO COPPER (II) CHLORIDE DIHYDRATE MFG. IN MILWAUKEE, WISCONSIN TRANEXAMIC ACID MFG. IN SHIZUOKA PREFECTURE, JAPAN L-ASPARAGINASE MFG. IN HOFU CITY, JAPAN HYDROXY-PROPYL BETA-CYCLODEXTRIN MFG. IN LESTREM, FRANCE GLIPIZIDE MFG. IN NORTH CHICAGO, ILLINOIS L-ISOLEUCINE MFG. IN OSAKA, JAPAN CHILD-RESISTANT SACHET OVERWRAP MFG. IN GILLINGHAM, KENT, ENGLAND EASI-TEAR OVERWRAP MFG. IN GILLINGHAM, KENT, ENGLAND FACILITIES AND OPERATING PROCEDURES IN ZURICH, SWITZERLAND CMC CARBOXYMETHYLCELLULOSE SODIUM MFG. IN HOPEWELL, VIRGINIA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FREEPORT, BRITISH ISLES. JOHNSON AND JOHNSON PHARMACEUTICAL NON-CLINICAL PHARMACOLOGY TOXICOLOGY STUDIES ON HYDROXYPROPYL-BETARESEARCH AND DEVELOPMENT LLC CYCLODEXTRIN (ENCAPSIN HPB) ARTIFICIAL SWEETNESS FLAVOR (284) #409284 AND/OR ARTIFICIAL SWEETNESS FLAVOR #40928T GLIBENCLAMIDE MANUFACTURED IN PISA, ITALY. ALPHA AND VANGUARD FILTER CARTRIDGES MFG. IN CAMARILLO CALIFORNIA NYLUX, CHEMDYNE, ULTRADYNE AND STYLUX FILTER CARTRIDGES MFG IN CAMARILLO, CALIFORNIA CARBIDOPA AS MFG. BY JUZEN CHEMICAL CO., LTD. IN TOYAMA-CITY, JAPAN SODIUM DIETHYLDITHIOCARBAMATE MFG. IN CARLSTADT, NEW JERSEY

WAITAKI INTERNATIONAL BIOSCIENCES SUB FETUIN (PEDERSEN) MFG. IN TORONTO, ONTARIO, CANADA WAITAKI CANADA LTD PTI ADVANCED FILRATION INC POLYFLOW AND POLYFLOW PROTECTOR MANUFACTURED IN NEWBURY PARK, CALIFORNIA. SANDOZ GMBH CEPHALOSPORIN C SODIUM MFG. IN KUNDL, AUSTRIA BIO-RAD LABORATORIES BIO-GEL HT (HYDROXYAPAITE) MANUFACTURERD IN RICHMOND, CALIFORNIA.

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4Q2012EXCEL DMF# 9439 9440 9441 9442 9443 9444 9445 I 9446 I 9447 9448 9449 9450 9451 9452 9453 9454 9455 I 9456 I 9457 I 9458 I 9459 I 9460 I 9461 I 9462 9463 9464 9465 9466 A 9467 I 9468 9469 9470 I I I II II I 12/18/1991 12/19/1991 12/26/1991 ROCHE DIAGNOSTICS GMBH SCIENTIFIC PROTEIN LABORATORIES KYORIN PHARMACEUTICAL CO LTD III 12/17/1991 I I I I II II II II III 12/13/1991 12/18/1991 12/12/1991 12/19/1991 12/13/1991 BOEHRINGER MANNHEIM GMBH MALLINCKRODT CHEMICAL INC CAMBRIDGE CHEMICAL INC DOW CORNING CORP SIEGWERK DRUCKFARBEN AG AND CO KGAA TECH SEAL PRODUCTS INC I 12/13/1991 I 12/12/1991 MARION MERRELL DOW RESEARCH AND DEVELOPMENT CENTRE MITSUBISHI KASEI CORP I 12/11/1991 UNION QUIMICO FARMACEUTICA SA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF CIMETIDINE USP IN BARCELONA, SPAIN. FACILITIES LOCATED IN WINNERSH, BERKSHIRE, THE UNITED KINGDOM MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MIE PREFECTURE, JAPAN. QUININE SULFATE MFG. IN MANNHEIM, GERMANY CALCITONIN, SALMON MANUFACTURED IN ST. LOUIS, MISSOURI. 2,7-DIMETHYL-FMOC-L-LEUCINE MFG. IN MILWAUKEE, WISCONSIN II 12/13/1991 I 12/10/1991 I 12/7/1991 FUJISAWA PHARMACEUTICAL COMPANY LTD FUJISAWA PHARMACEUTICAL COMPANY LTD NORISTAN LTD FACILITY LOCATED IN NAGOYA, JAPAN FACILITY LOCATED IN OSAKA, JAPAN I I I I I A I I II II II II I III I II I 12/5/1991 11/12/1991 12/12/1991 12/12/1991 12/12/1991 12/12/1991 12/16/1991 12/9/1991 12/5/1991 PHARMACHEM CORP EXPANSIA MEISEI CHEMICAL WORKS LTD MEISEI CHEMICAL WORKS LTD MEISEI CHEMICAL WORKS LTD HEINKE TECHNOLOGY INC SIMAFEX CHEMI SPA BOEHRINGER MANNHEIM GMBH I 12/10/1991 DSM ANDENO STATUS Type SUBMIT DATE I I I I I I III II II II II I II 12/3/1991 11/11/1991 11/27/1991 11/27/1991 11/11/1991 12/10/1991 12/10/1991 HOLDER VETROPACK LTD. QUIMICA SINTETICA S A PENICK CORP LUSOCHIMICA S P A QUIMICA SINTETICA S A DERIVADOS QUIMICOS S A DSM ANDENO SUBJECT RAW MATERIALS AND MFG. OF GLASS BOTTLES IN WAUWIL, SWITZERLAND KETOTIFEN FUMERATE MFG. IN MADRID, SPAIN OXYCODONE TEREPHTHALATE MFG. IN NEWARK, NEW JERSEY ACEBUTOLOL HYDROCHLORIDE MFG. IN LOMAGNA, ITALY ASTEMIZOLE MFG. IN MADRID, SPAIN FACILITIES AND OEPRAING PROCEDURES IN MURCIA, SPAIN

4Q2012

METHYL (2R,3S)-(-)-3-(4-METHOXYPHENYL) OXIRANE-2-CARBOXYLATE (MEFA) MFG. IN VENLO, THE NETHERLANDS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN VENLO, THE NETHERLANDS. DEXTRAN SULFATE MFG. IN BETHLEHEM, PENNSYLVANIA POLY A. POLY U BULK DRUG MFG. IN ARAMON, FRANCE POLY(ETHYLENE OXIDE) ALKOX R-400 PF MFG. IN TSU-CITY, JAPAN POLY(ETHYLENE OXIDE) ALKOX E-160 PF MFG. IN TSU-CITY, JAPAN FACILITIES AND OPERATING PROCEDURES IN TSU-CITY, JAPAN VCA-3 VAGINAL CREAM APPLICATOR MFG. IN LINCOLN, NEBRASKA FACILITY IN MARANS, FRANCE 5-AMINOSALICYLIC ACID (MESALAZINE) MFG. IN PARICA (FROSINONE), ITALY PRODUCTION PLANT HC-B 4 AND EXTRACTION PLANT HC-B 10 IN MANNHEIM, GERMANY

DICYCLOMINE HYDROCHLORIDE MFG. IN WALTLOO, PRETORIA, REP. OF SOUTH AFRICA

SILASTIC MDF-0108 MEDICAL GRADE TUBING MANUFACTURD IN HEMLOCK, MICHIGAN. EPOXY AMINE TWO COMPONENT INKS FOR PRINTING POLYESTER FILMS, BARGEN BE, SWITZERLAND LINER MATERIALS AND TAMPER EVIDENCE INNERSEALS MANUFACTURED IN WHEELING, WEST VIRGINIA. CYTOSINE - ARABINOFURANOSIDE MFG. IN MANNHEIM, GERMANY DERMATAN SULFATE MFG. IN WAUNAKEE, WISCONSIN FACILITIES FOR THE MFG. OF FLEROXACIN BULK DRUG SUBSTANCE AT THE OKAYA PLANT IN NAGANO, JAPAN

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4Q2012EXCEL DMF# 9471 9472 9473 9474 9475 9476 I 9477 9478 9479 9480 I 9481 9482 9483 I 9484 9485 9486 9487 9488 9489 9490 I 9491 I 9492 9493 9494 I 9495 9496 9497 9498 I 9499 9500 I 9501 9502 9503 I 9504 I IV 1/14/1992 AMERICAN MAIZE PRODUCTS CO A I II I IV 1/10/1992 1/13/1992 1/14/1992 BASF SE BOEHRINGER MANNHEIM GMBH ATOCHEM I III I 12/20/1991 1/7/1992 WEST CO INC FLEXCON CO I I I II II II I 1/14/1992 1/10/1992 12/11/1991 1/3/1992 GIST BROCADES SYNTHELABO RECHERCHE RENKER GMBH AND CO KG OGDDEN BIOSERVICES CORP I A IV II I 1/7/1992 1/8/1992 12/30/1991 II 12/31/1991 I A A A A A II II II II II II II 1/6/1992 1/3/1992 1/3/1992 1/3/1992 1/6/1992 1/7/1992 12/6/1991 BURROUGHS WELLCOME (INDIA) LTD EVONIK CORPORATION EVONIK COPORATION EVONIK CORPORATION YONEYAMA YAKUHIN KOGYO CO LTD 5N PLUS LUBECK GMBH I A II II II 12/17/1991 1/8/1992 1/10/1992 PHARMECO LABORATORIES INC MEDICHEM SA BIOCHIMICA OPOS 2 SPA LEVOBUNOLOL HYDROCHLORIDE MFG. IN SIMI VALLEY, CALIFORNIA LEVOBUNOLOL HYDROCHLORIDE MFG. IN GERONA, SPAIN A I I II II II II 11/25/1991 12/31/1991 12/16/1991 12/16/1991 PIERRE FABRE MEDICAMENT ASTELLAS PHARMA INC ASTELLAS PHARMA INC STATUS Type SUBMIT DATE I A I I I I II IV II II II 12/20/1991 12/23/1991 12/19/1991 12/26/1991 1/2/1992 12/31/1991 HOLDER LIPHA SA SANOFI CHIMIE MITSUBISHI KASEI CORP CYGNUS INC APPLIED ANALYTICAL INDUSTRIES DM GRAHAM LABORATORIES INC SUBJECT

4Q2012

FACILITIES AND PROCEDURES IN HERTFORDSHIRE AND MIDDLESEX, ENGLAND HEPARIN SODIUM MFG. IN PLOERMEL, FRANCE SUCROSE STEARATE RYOTO MFG. IN MIE PREFECTURE, JAPAN FENTANYL TRANSDERMAL SYSTEM (FENTANYL TS) SUCROSE OCTASULFATE, AMMONIUM SALT MFG. IN WILMINGTON, NORTH CAROLINA ACETAMINOPHEN CONTROLLED-RELEASE BEADS 325 MG. AS MFG. IN HOBART, NEW YORK VINORELBINE DITARTRATE MFG. IN GAILLAC CEDEX, FRANCE CEFIXIME MFG. IN TAKAOKA, JAPAN 7 ACA-A48 MFG. IN OSAKA, JAPAN

FUJISAWA PHARMACEUTICAL COMANY LTD STERILE CEFAZOLIN SODIUM MFG. IN THE FUJI PLANT, JAPAN

DOBUTAMINE HYDROCHLORIDE, BULK, NON STERILE PYROGEN FREE AS MFG. IN MILAN, ITALY PSEUDOEPHEDRINE HYDROCHLORIDE MANUFACTURED IN BOMBAY, INDIA. GLYCYL-L-TYROSINE DIHYDRATE MFG. IN HAM, FRANCE L-ALANYL-L-GLUTAMINE MFG. IN HAM, FRANCE GLYCYL-L-GLUTAMINE MONOHYDRATE MFG. IN HAM, FRANCE L-LEUCINE MFG. AT THE MIKUNI PLANT, JAPAN BISMUTH CITRATE MFG. IN LUBECK, GERMANY

SHANGHAI ZHONGXI PHARMACEUTICAL CO HYDROXYCHLOROQUINE SULFATE AS MANUFACTURED IN SHANGHAI, CHINA LTD CHONGQING PHARMACEUTICAL RESEARCH AMRINONE MFG. IN CHONGQING SICHUAN, PEOPLE'S REPUBLIC OF CHINA INSTITUTE SHAW MUDGE AND CO FRAGRANCE FORMULATIONS M-4600 AND U-8571 MFG. IN STAMFORD, CONNECTICUT LUSOCHIMICA SPA EMS DOTTIKON AG NICARDIPINE HYDROCHLORIDE MFG. IN LOMAGNA, (C0), ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DOTTIKON, SWITZERLAND. 6-AMINOPENICILLANIC ACID (6-APA) MFG. IN DELFT, THE NETHERLANDS ALPIDEM MFG. IN GARGENVILLE, FRANCE HOSTAPHAN RN 15 MFG. IN FREIBURG, GERMANY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. FASPAK ANTIBIOTIC CONTAINERS MFG. IN JERSEY SHORE, PENNSYLVANIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SPENCER, MASSACHUSETTS. SOLUTOL HS 15 MANUFACTURED IN LUDWIGSHAFEN, GERMANY. CHEMICAL PLANT HC-B 21 LOCATED IN MANNHEIM, GERMANY ETHYLENE-VINYL ACETATE COPOLYMERS PELLETS MANUFACTURD IN ORTHEZ, FRANCE HIGH FRUCTOSE CORN SYRUP MFG. IN DECATUR, ALABAMA AND DIMMITT, TEXAS

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4Q2012EXCEL DMF# 9505 9506 I 9507 9508 9509 9510 9511 9512 9513 9514 I 9515 9516 9517 9518 9519 I 9520 I 9521 I 9522 9523 I 9524 I 9525 I 9526 9527 9528 I 9529 9530 9531 9532 9533 9534 I 9535 9536 9537 I A I II III II 1/29/1992 2/14/1992 1/30/1992 PROMETIC BIOSCIENCES LTD MWV SLATERSVILLE LLC INALCO SPA I I I I I II II II II II I 1/29/1992 1/3/1992 1/3/1992 2/6/1992 2/3/1992 1/10/1992 QUIMICA SINTETICA S A LACHEMA BRNO LACHEMA BRNO ROCHE DIAGNOSTICS GMBH ROCHE DIAGNOSTICS GMBH OTSUKA PHARMACEUTICAL CO LTD I A II III I 1/3/1992 11/28/1991 1/31/1992 II 2/3/1992 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA LACHEMA BRNO ST GOBAIN DESJONQUERES SA SGD RIEDEL DEHAEN AG III 1/8/1992 RHONE POULENC INC A III II 1/20/1992 2/7/1992 WESTLAKE LONGVIEW CORP HAARMANN AND REIMER CORP II 1/15/1992 II 1/23/1992 I I I I III I II II I 1/24/1992 1/22/1992 1/31/1992 1/27/1992 1/27/1992 HELVOET PHARMA MARYLAND PHARMAGLOBE LABS LTD RAYLO CHEMICALS JOHNSON MATTHEY INC SCHERING PLOUGH INTERNATIONAL PHARMACEUTICAL DEVELOPMENT LABORATORY NATIONAL INSTITUTE CHILD HEALTH AND HUMAN DEVELOPMENT PROMETIC BIOSCIENCES LTD I I I A I I A I II III II II III II I 1/17/1992 10/16/1991 1/13/1992 1/20/1992 4/30/1992 1/17/1992 1/17/1992 1/17/1992 DEGUSSA AG NATIONAL STARCH AND CHEMICAL CORP FERRO CORP SIFAVITOR SRL DEGUSSA CORP FINDLEY ADHESIVES, INC. SASOL GERMANY GMBH SASOL NORTH AMERICA INC. FACILITY FOR THE MANUFACTURING OF DIPEPTIDE IN HANAU, GERMANY OCTYL DIMETHYL AMINOBENZOATE THERMOPLASTIC COMPOUNDS MFG. IN EVANSVILLE, INDIANA CYCLOBENZAPRINE HYDROCHLORIDE MANUFACTURED IN MILAN, ITALY. ELCEMA MANUFACTURED IN ELLWANGEN-HOLZMUHLE, GERMANY STATUS Type SUBMIT DATE I II II 1/17/1992 1/17/1992 HOLDER EVONIK DEGUSSA GMBH EVONIK DEGUSSA GMBH SUBJECT

4Q2012

GLYCYL-L-TYROSINE MANUFACTURED IN HANAU, FEDERAL REPUBLIC OF GERMANY. GLYCYL-L-GLUTAMINE MANUFACTURED IN HANAU, FEDERAL REPUBLIC OF GERMANY.

WATERBASED HEASEAL COATING C4408-01 MFG. IN WISCONSIN AND MICHIGAN 1-DOCOSANOL (BEHENYL ALCOHOL) MFG. IN BRUNSBUTTEL, GERMANY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF 1-DOCOSANOL (BEHENYL ALCOHOL) IN BRUNSBUTTEL, GERMANY. RUBBER CLOSURE FORMULATION B5015-50 GRAY FACILITIES AND PROCEDURES IN WINDSOR, NOVA SCOTIA, CANADA 2',3',5'-TRI-O-ACETYLURIDINE MFG. IN EDMONTON, ALBERTA, CANADA ORMAPLATIN MFG. IN WEST DEPTFORD, NEW JERSEY FACILITY IN DARDILLY, FRANCE

GONADOTROPIN RELEASING HORMONE (GNRH) MIMETIC BLUE 1 A6XL CHROMATOGRAPHIC MEDIA MFG. IN THE FREEPORT, BALLASALLA, ISLE OF MAN, BRITISH ISLES LOW-DENSITY POLYETHYLENE (LDPE) AS MANUFACTURED IN LONGVIEW, TEXAS NEO HELIOPAN OS (2-ETHYLHEXYL SALICYLATE) MFG. IN GOOSE CREEK, SOUTH CAROLINA COLLOID 581B MFG. IN NEWARK, NEW JERSEY, MISSISSAUGA, ONTARIO AND LOS ANGELES, CALIFORNIA TERFENADINE MFG. IN LATINA, ITALY METHOTREXATE SODIUM MFG. IN BRNO, CZECHOSLOVAKIA AMBER TYPE 1 GLASS VIALS MANUFACTURED IN MERS LES BAINS, FRANCE. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF PERFLUOROOCTYLBROMIDE MANUFACTURED IN SEELZE, GERMANY. ETODOLAC MFG. IN MADRID, SPAIN ACYCLOVIR MFG. IN BRNO, CZECHOSLOVAKIA TAMOXIFEN CITRATE MFG. IN BRNO, CZECHOSLOVAKIA GUAIACOL-O-ETHYLTOSYLATE MFG. IN MANNHEIM, FEDERAL REPUBLIC OF GERMANY 4-HYDROXYCARBAZOLE MFG. IN MANNHEIM, FEDERAL REPUBLIC OF GERMANY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TOKUSHIMA, JAPAN. LYSINE AGAROSE 6XL MFG. IN FREEPORT, BALLASALLA, ISLE OF MAN, BRITISH ISLES POLYTOP AND POLYCAM CLOSURES MFG. IN SLATERSVILLE, RHODE ISLAND LACTULOSE CRYSTALS MFG. IN PISTOIA, ITALY

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4Q2012EXCEL DMF# 9538 I 9539 9540 9541 9542 I 9543 A 9544 9545 I 9546 9547 I 9548 I 9549 9550 9551 9552 I 9553 9554 9555 I 9556 I 9557 A 9558 9559 9560 9561 9562 I 9563 I 9564 A 9565 9566 9567 9568 I I I I III III III III 2/8/1992 2/18/1992 2/18/1992 2/18/1992 HELVOET PHARMA MARYLAND SCHUBERT SEALS A/S SCHUBERT SEALS A/S SCHUBERT SEALS A/S II 3/6/1992 GILEAD SCIENCES INC II 2/12/1992 INTERFALK CANADA INC I I I I II II II II II 2/21/1992 2/21/1992 2/21/1992 2/21/1992 11/22/1991 SEPPIC SEPPIC SEPPIC SEPPIC INTERFALK CANADA INC IV 2/21/1992 ASAHI KASEI CHEMICALS CORP I 2/21/1992 I I II III III 12/11/1991 2/10/1992 1/23/1992 SEPRAGEN CORP ALCO CHEMICAL HB FULLER CO RESEARCH AND DEVELOPMENT LABORATORY ASAHI CHEMICAL INDUSTRY CO LTD I A I II III III II 2/10/1992 2/7/1992 2/11/1992 2/20/1992 VEREIN FUR KREBSFORSCHUNG SILGAN PLASTICS CANADA INC HIGH POINT PACKAGING CORP SUMITOMO CHEMICAL CO LTD I 2/10/1992 VEREIN FUR KREBSFORSCHUNG I II IV 2/17/1992 2/13/1992 PLANTEX LTD CHEM AND PHARM WORKS PHARMACEUTICAL INGREDIENTS LTD I II II 2/18/1992 2/10/1992 SYNTHELABO PHARMACIE SELTZER CHEMS INC III 2/7/1992 GERRESHEIMER GLASS INC I I I II II II I 2/13/1992 2/10/1992 1/3/1992 2/7/1992 PLIVA CHEMI SPA LACHEMA BRNO OGDEN BIOSERVICES CORP STATUS Type SUBMIT DATE I 2/19/1992 HOLDER TECH POULSON INC SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SCOTTSDALE, ARIZONA. METOPROLOL TARTRATE MFG. IN ZAGREB AND SAVSKI MAROF, CROATIA MICONAZOLE NITRATE MFG. IN PATRICA (FROSINONE), ITALY CARBOPLATIN MFG. IN BRNO, CZECHOSLOVAKIA

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ROCKIVILLE, MARYLAND. GLASS PACKAGING MATERIAL MFG. IN VINELAND, NEW JERSEY AND WARSAW, INDIANA AND MORGANTON, NORTH CAROLINA THIAZEPIN MFG. IN MONTARGIS CEDEX, FRANCE UBIDECARENONE (COENZYME Q 10) MFG. IN TOKYO, JAPAN BY DAINIPPON INK & CHEMICALS, INC. ETOPOSIDE MANUFACTURED IN NETANYA, ISRAEL. FIBROSOL (MODIFIED CARBOXYMETHYLCELLULOSE SODIUM) MFG. IN ROCKY HILL, NEW JERSEY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ARLESHEIM, SWITZERLAND ISCADOR MFG. IN ARLESHEIM, SWITZERLAND PLASTIC CONTAINERS MFG. IN BRAMPTON AND MISSISSAUGA, ONTARIO, CANADA PACKAGING MATERIALS FOR BOTTLE MANUFACTURING DIPIVEFRIN HYDROCHLORIDE MANUFACTURED IN GIGU-PREFECTURE AND OSAKA, JAPAN. SUPERFLOW CHROMATOGRAPHY COLUMN MFG. IN SAN LEANDRO, CALIFORNIA ALCOGUM 9710-P MANUFACTURED IN CHATTANOOGA, TENNESSEE. PRODUCT HM-0777 MFG. IN VADNAIS HEIGHTS, MINNESOTA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NOBEOKA, JAPAN. PREGELATINIZED STARCH PCS MANUFACTURED IN NOBEOKA ANDKASHIHARA CITY, JAPAN MONTANIDE ISA 740 MANUFACTURED IN CASTRES, FRANCE. MONTANIDE ISA 206 MFG. IN CASTRES, FRANCE MONTANIDE ISA 25 MFG. IN CASTRES, FRANCE MONTANIDE ISA 720 MANUFACTURED IN CASTRES, FRANCE. SALOFALK 250MG MESALAMINE ENTERIC COATED TABLETS MANUFACTURED BY SCHERING CANADA, INC. 4G/240ML ENTERAL SUSPENSION 5-AMINOSALICYLIC ACID (MESALAMINE) MFG. BY BIOPHARM INC. AMBISOME, LIPOSOMAL AMPHOTERICIN B MANUFACTURED IN SAN DIMAS, CALIFORNIA. RUBBER CLOSURE FORMULATION R5001-55 RED MFG. IN SALISBURY, MARYLAND RUBBER COMPOUND NO. 6449 MFG. IN HORSENS, DENMARK RUBBER COMPOUND 6454 MANUFACTURED IN HORSENS, DENMARK. RUBBER COMPOUND NO. 41013 MANUFACTURED IN HORSENS, DENMARK.

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4Q2012EXCEL DMF# 9569 9570 9571 9572 9573 9574 I 9575 9576 9577 9578 A 9579 9580 I 9581 I 9582 9583 9584 I 9585 9586 A 9587 9588 9589 9590 9591 9592 9593 I 9594 9595 I 9596 9597 9598 I 9599 9600 9601 I A A II IV II 3/4/1992 3/10/1992 3/26/1992 I I II I I 2/28/1992 3/16/1992 4/17/1992 I II I 3/16/1992 3/13/1992 I I I I I I I II II I I I I 3/15/1992 3/2/1992 3/19/1992 3/19/1992 3/19/1992 3/16/1992 3/10/1992 PRO.BIO SINT, S.R.L. KNOLL PHARMACEUTICAL CO SANTEN PHARMACEUTICAL CO LTD TAIHO PHARMACEUTICAL CO INC TAIHO PHARMACEUTICAL CO INC DAISO CO LTD MERCK PHARMACEUTICAL MANUFACTURING DIV PLENUM SCIENTIFIC RESEARCH INC BOEHRINGER INGELHEIM PHARMACEUTICALS INC STREM CHEMICALS INC SYNTEX LABS SAITAMA DAIICHI PHARMACEUTICAL CO., LTD TRIDENT ORGANICS PRIVATE LTD LIPOID GMBH JOHNSON MATTHEY INC I II IV 3/19/1992 3/2/1992 I I III III I 3/4/1992 2/21/1992 3/12/1992 I 2/28/1992 I II I 3/4/1992 3/3/1992 SOUTHERN RESEARCH INSTITUTE I A I III III II IV 3/5/1992 3/2/1992 2/25/1992 2/21/1992 HELVOET PHARMA MARYLAND EVONIK ROHM GMBH FUJI CHEMICAL INDUSTRIES CO LTD NOF CORP STATUS Type SUBMIT DATE I I I A A II II II II II I 3/2/1992 2/29/1992 3/4/1992 3/3/1992 3/10/1992 2/28/1992 HOLDER KYOWA HAKKO KOGYO CO LTD PENINSULA LABS PCR INC MALLINCKRODT INC MEDICHEM SA YUKI GOSEI KOGYO CO LTD SUBJECT ADENOSINE TRIPHOSPHATE DISODIUM MANUFACTURED IN UBE, JAPAN. [ASN1, VAL5] ANGIOTENSIN II MANUFACTURED IN BELMONT, CALIFORNIA. ISOFLURANE MFG. IN GAINESVILLE, FLORIDA NALTREXONE BASE (ESUB) AS MANUFACTURED IN ST. LOUIS, MISSOURI CHLORHEXIDINE ACETATE MFG. IN GERONA, SPAIN

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF GLYCINE IN IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN. RUBBER CLOSURE FORMULATION R2502-50 GRAY MFG. IN SALISBURY, MARYLAND DEGALAN LP AL 23 MANUFACTURED IN WESSLING, GERMANY. L-LYSINE 50% SOLUTION MANUFACTURED IN TOYAMA, JAPAN. DIMYRISTOYL PHOSPHATIDYL GLYCEROL SODIUM SALT MFG. IN AMAGASAKI-CITY, HYOGO, JAPAN INFLUENZA MICROSPHERES MFG. IN BIRMINGHAM, ALABAMA

CATAZYME DRUGS AND PHARMACEUTICALS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING LTD PROCEDURES IN TAMILNADU, INDIA KIPPGROUP MANFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF PLASTIC MOLDED COMPONENTS IN ONTARIO, CANADA. MITSUI CHEMICALS INC TAFMER-A4085X RESIN COMPOUND MFG. IN ICHIHARA-CITY, CHIBA, JAPAN MITSUI CHEMICALS INC PATHEON INC TORONTO REGION OPERATIONS KV PHARMACEUTICAL CO MILLIKEN AND CO TAFMER P RESIN COMPOUND MFG. IN ICHIHARA-CITY, CHIBA, JAPAN MANUFACTURING SITE, FACILITIES AND PERSONNEL IN FORT ERIE, ONTARIO, CANADA BUTOCONAZOLE NITRATE 2% VAGINAL CREAM MFG. IN ST. LOUIS, MISSOURI REACTINT YELLOW X15, BLUE X3LV, RED X52 AND ORANGE X38 MFG. IN BLACKSBURG, SOUTH CAROLINA FACILITY AND OPERATING PROCEDURES IN VARESE, ITALY BTS 67 582 MFG. IN NOTTINGHAM, ENGLAND RIMAIL MANUFACTURED IN OSAKA, JAPAN. FACILITIES FOR THE MFG. OF TEGAFUR IN SAITAMA, JAPAN FACILITIES IN TOKUSHIMA, JAPAN FACILITY FOR THE MFG. OF PINDOLOL IN MASUYAMA-CITY, JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SABANA HOYOS, PUERTO RICO. URIDINE TRIPHOSPHATE MFG. IN HACKENSACK, NEW JERSEY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RIDGEFIELD, CONNECTICUT. GALLIUM NITRATE HYDRATE MFG. IN NEWBURY, MA. FACILITIES AND CONTROLS IN BUENOS AIRES, ARGENTINA FACITLITIES AND PROCEDURES IN ONUMA, HANYU-SHI, SAITAMA PREFECTURE, JAPAN ASTEMIZOLE INTERMEDIATES MANUFACTURED IN ANDHRA PRADESH, INDIA LIPOID S 75 MANUFACTURED IN LUDWIGSHAFEN, GERMANY. CISPLATIN MFG. IN WEST DEPTFORD, NEW JERSEY

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4Q2012EXCEL DMF# 9602 A 9603 9604 9605 9606 I 9607 9608 9609 I 9610 9611 9612 9613 I 9614 I 9615 9616 9617 9618 9619 9620 9621 9622 I 9623 9624 I 9625 9626 I 9627 A 9628 9629 9630 9631 I 9632 9633 9634 I I I II III I 3/30/1992 3/23/1992 3/23/1992 PT SINKONA INDONESIA LESTARI ROLLPRINT PACKAGING PRODUCTS INC BIHOKU FUNKA KOGYO CO LTD I I I II I III I 3/30/1992 4/1/1992 3/24/1992 3/30/1992 BIO RAD LABORATORIES FUJISAWA PHARMACEUTICAL CO LTD COLOR CONVERTING INDUSTRIES PT SINKONA INDONESIA LESTARI IV 3/30/1992 BIO RAD LABORATORIES INC I II II 4/1/1992 3/30/1992 NEWPORT PHARMACEUTICALS (IRELAND) BIO RAD LABORATORIES I III II 4/1/1992 3/30/1992 TUREX INC HAMARI CHEMICALS LTD I I I I A I I II II II II II II II I 10/1/1990 5/7/1969 5/7/1969 10/19/1990 9/30/1992 3/16/1992 4/2/1992 3/30/1992 HAMARI CHEMICALS LTD PHARMACIA PL BIOCHEMICALS INC PHARMACIA PL BIOCHEMICALS INC CARLBIOTECH LTD AS CAMBREX PROFARMACO MILANO SRL SYNTEX SA PLAISTOW LTD HAMARI CHEMICALS LTD II 12/14/1988 BACHEM FEINCHEMIKALIEN AG I I I III IV III II 2/13/1992 3/16/1992 3/5/1992 5/15/1991 RHONE POULENC INC METSA SPECIALTY CHEMICALS BV AMPACET CORP PROCYTE CORP A I III III III 3/16/1992 3/20/1992 3/6/1992 3M DRUG DELIVERY SYSTEMS ROLLPRINT PACKAGING PRODUCTS INC DSM THERMOPLASTIC ELASTOMERS, INC. I I A II II IV II 3/18/1992 3/24/1992 3/23/1992 3/25/1992 TOMITA PHARMACEUTICAL CO LTD CARLBIOTECH LTD AS LIPOID KG WACKER CHEMIE GMBH STATUS Type SUBMIT DATE III 3/19/1992 HOLDER SILGAN PLASTICS CORP SUBJECT

4Q2012

PLASTIC TUBES MANUFACTURED IN MUSCATINE, IOWA AND WASHINGTON COURT HOUSE, OHIO FERRIC AMMONIUM CITRATE, BROWN MFG. IN NARUTO-CITY, JAPAN OXYTOCIN MFG. IN COPENHAGEN, DENMARK LIPOID S 100 MFG. IN LUDWIGSHAFEN, GERMANY 2-(2-METHOXYETHOXY) ACETALDEHYDE DIMETHYL ACETAL AS MANUFACTURED IN BURGHAUSEN, GERMANY 9720 POLYETHYLENE FILM MFG. IN BROOKINGS, SOUTH DAKOTA RPP # 26-1054 MFG. IN ADDISON, ILLINOIS SARLINK 2400 SERIES OF THERMOPLASTICS ELASTOMERS MANUFACTURED IN LEOMINSTER, MASSACHUSETTS COLLOID 999 MANUFACTURED IN KENNESAW, GEORGIA. SODIUM CARBOXYMETHYLCELLULOSE MFG. IN NIJMEGEN, THE NETHERLANDS 11171-101 WHITE PE/MB MFG. IN TARRYTOWN, NEW YORK GLY-HIS-LYS TRIPEPTIDE COPPER CHELATE AS MANUFACTURED IN KIRKLAND, WASHINGTON GLY-HIS-LYS TRIPEPTIDE COPPER CHELATE AS MANUFACTURED IN BUBENDORF, SWITZERLAND GLY-HIS-LYS TRIPEPTIDE COPPER CHELATE AS MANUFACTURED IN OSAKA, JAPAN POLYCYTIDYLIC ACID (POLY 1) AS MANUFACTURED IN MILWAUKEE, WISCONSIN POLYCYTIDYLIC ACID (POLY C) AS MANUFACTURED IN MILWAUKEE, WISCONSIN (D-ALA1)-PEPTIDE-T AMIDE AS MANUFACTURED IN COPENHAGEN, DENMARK CYSTEAMINE BITARTRATE MANUFACTURED IN MILAN, ITALY. HEPARIN SODIUM MANUFACTURED IN BUENOS AIRES, ARGENTINA. PROPIRAM FUMERATE MANUFACTURED IN LITTLE ISLAND, COUNTY CORK, IRELAND. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN OSAKA, JAPAN. PACKAGING MATERIAL MFG. IN HARRISVILLE, RHODE ISLAND (3S)-1,2,3,4-TETRAHYDRO-3-ISOQUINOLINECARBOXYLIC ACID BENZYL ESTER PTOLUENESULFONIC ACID SALT THIQ-B MFG. IN OSAKA, JAPAN PENTAMIDINE ISETHIONATE MFG. IN DUBLIN, IRELAND MACRO-PREP S STRONG CATION EXCHANGE SUPPORT MFG. IN RICHMOND, CALIFORNIA MACRO-PREP CM WEAK CATION EXCHANGE SUPPORT MFG. IN RICHMOND, CALIFORNIA MACRO-PREP Q STRONG ANION EXCHAGE SUPPORT MFG. IN RICHMOND, CALIFORNIA FACILITY IN TOYOMA, JAPAN PRINTING INK FOR PACKAGING MATERIALS AS MANUFACTURED IN DES MOINES, IOWA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CIATER, INDONESIA. QUINIDINE SULFATE MANUFACTURED IN CIATER, INDONESIA. RPP #26-1066 MANUFACTURED IN ADDISON, ILLINOIS. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF CALCIUM CARBONATE IN OKAYAMA, JAPAN. Page

269

4Q2012EXCEL DMF# 9635 I 9636 9637 9638 9639 A 9640 9641 9642 9643 A 9644 9645 9646 9647 I 9648 9649 9650 I 9651 I 9652 9653 9654 9655 9656 I 9657 I 9658 9659 9660 9661 I 9662 9663 I 9664 9665 I 9666 I II 5/4/1992 I II II 4/30/1992 4/28/1992 SOLCHEM ITALIANA SPA A IV I 4/21/1992 4/30/1992 I A A II II II V 4/30/1992 4/24/1992 4/20/1992 4/20/1992 JOHNSON MATTHEY INC SPI PHARMA INC 5N PLUS LUBECK GMBH WISCONSIN ANALYTICAL AND RESEARCH SERVICES LTD DMV FONTERRA EXCIPIENTS GMBH CO KG SS PHARMACEUTICAL CO LTD I 4/10/1992 FBG TRIDENT LTD MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERTAING PROCEDURES OF GLASS CONTAINERS IN UNITED KINGDOM. AURANOFIN MANUFACTURED IN WEST DEPTFORD, NEW JERSEY. CALCIUM CARBONATE/STARCH GRANULATION MFG. IN JOLIET, ILLINOIS BISMUTH SUBSALICYLATE MFG. IN LUBECK, GERMANY DETERMINATION OF IBUPROFEN IN HUMAN PLASMA IN MADISON, WISCONSIN I A A I II II IV II II 5/11/1992 4/23/1992 4/16/1992 4/28/1992 4/10/1992 SUMITOMO CHEMICAL CO LTD PHARMACIA AND UPJOHN SUB PFIZER INC DUPONT FLUOROPRODUCTS GUILIN PHARMACEUTICAL FACTORY EVONIK DEGUSSA GMBH I 5/11/1992 RHONE POULENC CHEMICALS I A II II II 4/16/1992 4/9/1992 4/20/1992 CHEMI SPA SCIENTIFIC PROTEIN LABORATORIES LLC POPULATION COUNCIL A I I III III III I 4/13/1992 4/1/1992 4/8/1992 3/31/1992 MEDIPLAST CO LAWSON MARDON WHEATON INC COMPLEX TOOLING AND MOLDING CLINICAL TRIAL SERVICES I I A III II V II 4/7/1992 4/8/1992 3/27/1992 4/15/1992 HELVOET PHARMA MARYLAND ERREGIERRE SPA PIERRE FABRE MEDICAMENT PRODUCTION 2 NOVARTIS PHARMACEUTICALS CORP I I I II II II II 4/6/1992 4/9/1992 4/9/1992 4/3/1992 HONEYWELL IROPHARM PLC GEDEON RICHTER LTD SANOFI SYNTHELABO INC. MALLINCKRODT INC STATUS Type SUBMIT DATE I 4/3/1992 HOLDER TAYLOR PHARMACAL CO SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DECATUR, ILLINOIS. BROMPHENIRAMINE BASE MFG. IN WICKLOW, IRELAND CIMETIDINE AS MFG. IN BUDAPEST, HUNGARY TICLOPIDINE HYDROCHLORIDE MANUFACTURED IN SISTERON, FRANCE.

4Q2012

BOWEL MARKER CODE 7031 (FERUMOXSIL) (ESUB) MANUFACTURED IN ST. LOUIS, MISSOURI. RUBBER CLOSURE FORMULATION N4005-40 RED MFG. IN SALISBURY, MARYLAND FLURBIPROFEN MANUFACTURED IN BERGAMO, ITALY. STERILE MANUFACTURING FACILITY IN PAU IDRON, FRANCE LIORESAL INTRATHECAL AMPULS/BACLOFEN (ESUB) MANUFACTURED IN SUMMIT, NEW JERSEY PACKAGING MATERIAL MFG. IN ETOBICOKE, ONTARIO CANADA MOLDED GLASS CONTAINERS MFG. IN MILLVILLE, NEW JERSEY PACKAGING MATERIAL MG. IN RANDLEMAN, NORTH CAROLINA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CRAIGAVON, NORTH IRELAND. MICONAZOLE BASE AS MFG. IN FROSINONE, ITALY PANCREATIN/ PANCRELIPASE MFG. IN WAUNAKEE, WISCONSIN 17-(ACETYOXY)-16- METHYLENE -19-NONPREGN-4-ENE-3,20-DIONE MFG. IN BUDAPEST AND DOROG, HUNGARY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN AVONMOUTH, BRISTOL, ENGLAND. LEVOBUNOLOL HYDROCHLORIDE MFG. IN OSAKA AND ANPACHIGUN, JAPAN 16A-HYDROXYPREDNISOLONE MANUFACTURED IN KALAMAZOO, MICHIGAN. HFC134A (TETRAFLUOROETHANE) MANUFACTURED IN INGELSIDE, TEXAS. MEBENDAZOLE MANUFACTURED IN GUILIN, GUANGXI, PEOPLE'S REPUBLIC OF CHINA. L-ALANYL-L-GLUTAMINE MANUFACTURED IN HANAU, FEDERAL REPUBLIC OF GERMANY.

PRIMELLOSE (CROSCARMELLOSE SODIUM) MFG. IN FOXHOL, THE NETHERLANDS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN IVX-E-59 IN TOKYO, JAPAN. ACEBUTOLOL HYDROCHLORIDE MFG. IN MILAN, ITALY

NORTHEAST GENERAL PHARMACEUTICAL AMANTADINE HYDROCHLORIDE MFG. IN SHENYANG, PEOPLE'S REPUBLIC OF CHINA FACTORY LIANYUNGANG PHARMACEUTICAL FACTORY VALPROIC ACID MANUFACTURED IN LIANYUNGANG CITY, PEOPLES'S REPUBLIC OF CHINA.

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4Q2012EXCEL DMF# 9667 9668 I 9669 9670 9671 9672 9673 I 9674 9675 I 9676 9677 9678 A 9679 I 9680 A 9681 9682 I 9683 I 9684 I 9685 I 9686 9687 I 9688 9689 I 9690 I 9691 9692 9693 9694 I 9695 I III 5/28/1992 SPARTECH POLYCOM I I I I II II I 5/19/1992 5/20/1992 5/21/1992 5/8/1992 I 5/13/1992 A II I 5/13/1992 5/11/1992 CAYMAN PHARMA SRO PROMIX LABORATORIES DIV PATHEON GROUP INC SHANGHAI WANDAI PHARMACEUTICAL CO LTD R P SCHERER LTD RIEDEL DEHAEN AG ALBEMARLE CORP BANYU PHARMACEUTICAL CO LTD A V I 5/19/1992 5/7/1992 II 5/13/1992 I 5/13/1992 II 5/13/1992 SHANGHAI NUMBER 16 PHARMACEUTICAL FACTORY SHANGHAI NUMBER 16 PHARMACEUTICAL FACTORY SHANGHAI WANDAI PHARMACEUTICAL CO LTD STERIS-ISOMEDIX SERVICES REXAM CONTAINERS LTD A II III 5/7/1992 5/6/1992 AVANTI POLAR LIPIDS INC TOYO ALUMINUM PALMITIC ACID AS MFG. IN ALABASTER, ALABAMA II 5/7/1992 AVANTI POLAR LIPIDS INC I 4/30/1992 PROCTER AND GAMBLE CO I I IV II III 5/2/1992 5/7/1992 5/6/1992 REXAM RELEASE BV RIEDEL DEHAEN AG TOYO ALUMINUM KK A III I 5/14/1992 5/13/1992 PRETIUM PACKAGING TORCAN CHEMICAL LTD I I I I III III III II II 4/21/1992 4/21/1992 1/29/1992 5/8/1992 5/1/1992 ALUMINUM COMPANY OF AMERICA ALUMINUM COMPANY OF AMERICA ODENSE FLEXIBLE APS SALK INSTITUTE WHATMAN STATUS Type SUBMIT DATE I IV I 4/20/1992 4/22/1992 HOLDER FLAVOR NORTH AMERICA INC DIAGNOSTIC CHEMICALS LTD SUBJECT NATURAL & ARTIFICIAL LIME AND LEMON FLAVORS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CHARLOTTETOWN, P.E.I. , CANADA. PHAR 9500 (MEDICAL BLISTER PACK) PHAR 9501 (MEDICAL BLISTER PACK)

4Q2012

COMPOUND PACKAGING MATERIAL MANUFACTURED IN ODENSE S. DENMARK. AZALINE B MFG. IN LA JOLLA, CALIFORNIA CM-CELLULOSE/D5001 (CARBOXYMETHYL CELLULOSE) MANUFACTURED IN KENT, ENGLAND. POLYETHYLENE BOTTLES MANUFACTURED IN MONTREAL, QUEBEC, CANADA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN AURORA, ONTARIO, CANADA. FL2000 OPP 60 MFG. IN APELDOORN AND PERLEN, THE NETHERLANDS. 4-CHLOROBENZYLIDENEPHTHALIDE AS MFG. IN SEELZE, GERMANY PROCESSED ALUMINUM FOILS FOR BLISTER (PTP)/STRIP PACKAGE OF PHARMACEUTICAL TABLETS/CAPSULES MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LONGJUMEAU CEDEX, FRANCE. 1,2-DILAUROYL-SN-GLYCERO-3-PHOSPHOCHOLINE AS MFG. IN ALABASTER, ALABAMA

ALUMINUM FOIL FOR BLISTER(PIP)/STRIP PACKAGING OF PHARMACEUTICAL TABLETS AS LOCATED A THE GUMMA PLANT, JAPAN 1,3-DIMETHYL-4-AMINO-5-FORMYLAMINOURACIL MANUFACTURED IN SHANGHAI, CHINA. FACILITY ON QU-XI ROAD, SHANGHAI, CHINA THEOPHYLLINE (ANHYDROUS) AS MFG. IN SHANGHAI, CHINA CONTRACT STERILIZATION FACILITY IN EL PASO, TX MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HAMPSHIRE, UNITED KINGDOM. ALPROSTADIL (PGE1) AS MANUFACTURED IN NERATOVICE, CZECH REPUBLIC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BURLINGTON, ONTARIO, CANADA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SHANGHAI, CHINA. FACILITIES AND PERSONNEL IN SWINDON, WILTSHIRE, ENGLAND PERFLUOROOCTYLBROMIDE AS MFG. IN SEELZE, GERMANY S(+)-IBUPROFEN AS MFG. IN ORANGEBURG, SOUTH CAROLINA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN OKAZAKI CITY, JAPAN. PP5140 K3 NATURAL TALC-FILLED POLYPROPYLENE 40% AS MFG. IN DONORA, PENNSYLVANIA

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4Q2012EXCEL DMF# 9696 I 9697 9698 I 9699 9700 I 9701 9702 9703 9704 9705 A 9706 I 9707 9708 9709 9710 I 9711 9712 9713 9714 9715 9716 9717 I 9718 9719 9720 I 9721 I 9722 9723 9724 I 9725 I 9726 I II 6/12/1992 CHISSO CORP II 6/12/1992 CHISSO CORP I I II II II 6/12/1992 6/12/1992 6/12/1992 CHISSO CORP CHISSO CORP CHISSO CORP II 6/12/1992 I I III 1/20/1992 II 5/19/1992 QUIMICA SINTETICA SA HEM RESEARCH INC SWIFT ADHESIVES DIV REICHHOLD CHEMICALS INC CHISSO CORP 81463 ADHESIVE AS MFG. IN DOWNERS GROVE, ILLINOIS I I I I I A II II I I V II II 5/29/1992 6/2/1992 6/5/1992 6/5/1992 6/4/1992 6/8/1992 6/5/1992 I I I I III II II 6/5/1992 6/3/1992 6/4/1992 6/4/1992 SUMIKA FINE CHEMICALS CO LTD HELVOET PHARMA MARYLAND CIBA GEIGY CORP PHARMACEUTICAL DIV HOECHST ROUSSEL PHARMACEUTICALS INC NIPPON JUNRYO CHEMICALS CO LTD HOUBA INC SUMIKA FINE CHEMICALS CO LTD SUMIKA FINE CHEMICALS CO LTD ASTRA HASSLE A.B. CU CHEMIE UETIKON GMBH AVANTI POLAR LIPIDS INC II 5/18/1992 SIGMA F AND D DIV LTD A I I I II II II II III 5/27/1992 5/22/1992 5/29/1992 5/21/1992 5/29/1992 I II I 5/29/1992 5/26/1992 NITROCLOR PRODUCTS QUIMICOS SA MJ AGRO CHEMICALS PRIVATE LTD MANUFACTURERS EXPORTERS MEDICHEM SA ZAMBON GROUP SPA CHEMSYN SCIENCE LABORATORIES FABBRICA ITALIANI SINTETICI SPA SEALED AIR CORP I I II 5/29/1992 5/27/1992 NIPPON ROCHE KK FUJISAWA PHARMACEUTICAL CO LTD STATUS Type SUBMIT DATE I 5/29/1992 HOLDER ABBOTT LABORATORIES SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NORTH CHICAGO, ILLINOIS. FACILITIES AND OPERATING PROCEDURES IN FUKUROI CITY, JAPAN

4Q2012

FK-037 DRUG SUBSTANCE (INJECTABLE CEPHALOSPORIN) MANUFACTURED IN OSAKA, JAPAN. PARA-ACETAMINOPHEN MANUFACTURED IN BRAZIL. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ANKLESHWAR, INDIA. CHLORHEXIDINE GLUCONATE MANUFACTURED IN GERONA, SPAIN. FLUBIPROFEN AS MFG. IN VICENZA, ITALY ALTRETAMINE MFG. IN HARRISONVILLE, MISSOURI CALCIUM CHANNEL BLOCKER - RO 40-5967/001 AS MFG. IN VICENZA, ITALY M310 AND M530 SERIES OF MEDICAL PACKAGING MANUFACTURED IN DUNCAN, SOUTH CAROLINA N-HYDROXYSUCCINIMIDOBIOTIN - PRODUCT NO. H 1759 FD MANUFACTURED IN SAINT LOUIS, MISSOURI FACILITIES AND PROCEDURES IN OSAKA, JAPAN LZ 519 RUBBER CLOSURE FORMULATION MFG. IN SALISBURY, MARYLAND NAPHAZOLINE HYDROCHLORIDE MANUFACTURED IN SUMMIT, NEW JERSEY. HP 290 MANUFACTURE, ISOLATION, PURIFICATION AND TESTING IN SOMERVILLE, NEW JERSEY 5-AMINOSALICYLIC ACID AS MFG. IN NIIGATA, JAPAN ZIDOVUDINE MANUFACTURED IN CULVER, INDIANA. FACILITIES AND PROCEDURES A THE GIFU PLANT, JAPAN FACILITIES AND PROCEDURES A THE OKAYAMA PLANT IN JAPAN STUDIES CONDUCTED WITH ALMOKALANT 4-PHENYLBUTYRIC ACID SODIUM SALT MANUFACTURED IN LAHR, GERMANY. 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-[PHOSPHO-RAC-(1-GLYCEROL)] AS MFG. IN ALABASTER, ALABAMA KETOCONAZOLE AS MFG. IN MADRID, SPAIN

CELLUFINE GCL-25 AND GCL-90 GEL FILTRATION CHROMATOGRAPHY MEDIA AS MFG. IN MINAMAA, JAPAN CELLUFINE GCL-1000 CHROMATOGRAPHY MEDIA AS MFG. IN MINAMAA, JAPAN CELLUFINE GCL-300 CHROMATOGRAPHY MEDIA AS MFG. IN MINAMAA, JAPAN FMP ACTIVATED CELLUFINE AFFINITY CHROMATOGRAPHY MEDIA AS MFG. IN MINAMAA, JAPAN CELLUFINE GCL-2000 GEL FILTRATION CHROMATOGRAPHY MEDIA AS MFG. IN MINAMAA, JAPAN CHELATE CELLUFINE AFFINITY CHROMATOGRAPHY MEDIA AS MFG. IN MINAMAA, JAPAN

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4Q2012EXCEL DMF# 9727 A 9728 9729 I 9730 9731 9732 9733 9734 9735 I 9736 I 9737 9738 9739 9740 9741 9742 9743 9744 9745 9746 I 9747 9748 9749 9750 9751 9752 I 9753 A 9754 9755 9756 9757 9758 9759 9760 I I I A I I A II II IV II II II I 6/26/1992 6/24/1992 6/24/1992 7/11/1990 7/11/1990 7/11/1990 6/26/1992 KNOLL PHARMA CHEMICALS SEPPIC DIV AIR LIQUIDE SEPPIC SA BIOCRAFT LABORATORIES INC TEVA PHARMACEUTICALS USA INC TEVA PHARMACEUTICAL INDUSTRIES LTD II 6/29/1992 HOSPIRA I I I I A I II I I III I 6/23/1992 6/29/1992 6/26/1992 6/15/1992 7/1/1992 6/30/1992 HEINRICH MACK NACHFOLGER SANTEN OY RICERCA INC MARVAL INDUSTRIES INC DAIICHI PURE CHEMICALS CO LTD I I I I A I I I I II II II IV III I II II II III 6/17/1992 6/23/1992 6/12/1992 6/18/1992 6/19/1992 6/24/1992 6/23/1992 9/8/1987 6/23/1992 6/19/1992 I 6/23/1992 DAINIPPON INK AND CHEMICAL INC BIOCHEMICAL DIV TAKEDA CHEMICAL INDUSTRIES LTD DAIICHI PHARMACEUTICAL CO LTD JOHNSON MATTHEY INC F AND C INTERNATIONAL INC EXXONMOBIL CHEMICAL CO SOUTHERN RESEARCH INSTITUTE DSN ANTI-INFECTIVES INDIA LIMITED MAX GB LTD SHANDONG WEI FANG PHARM FACTORY HPG INTERNATIONAL INCORPORATED I I I N I II I 6/23/1992 6/11/1992 IV IV II 6/15/1992 6/15/1992 6/8/1992 I III II 6/10/1992 6/17/1992 HEINKE TECHNOLOGY INC DSM PHARMA CHEMICALS NETHERLANDS BV NIPPON FINE CHEMICAL LTD NIPPON FINE CHEMICAL LTD SIGMA F AND D DIV LTD NOT AN ASSIGNED NUMBER ALCHYMARS APPLIED ANALYTICAL INDUSTRIES SELEGILINE HYDROCHLORIDE AS MFG. IN MILAN, ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WILMINGTON, NORTH CAROLINA. FACILITY FOR THE MANUFACTURE OF PANTHETHINE IN TOKYO, JAPAN TNP-470 AS MFG. IN OSAKA, JAPAN DT-5621 DRUG SUBSTANCE AS MFG. IN AKITA, JAPAN CNS-1044 MFG. IN WEST DEPTFORD, NEW JERSEY COCOANUT BASE 41 (#11706T) MFG. IN CINCINNATI, OHIO ETHYLENE-BUTENE COPOLYMERS STATUS Type SUBMIT DATE II 6/9/1992 HOLDER AVANTI POLAR LIPIDS INC SUBJECT 1,2-DIPALMITOYL-SN-GLYCERO-3-[PHOSPHO-RAC-(1-GLYCEROL)] AS MFG. IN ALABASTER, ALABAMA VCA-6CC VAGINAL CREAM APPLICATOR AS MFG. IN LINCOLN, NEBRASKA

4Q2012

ETHYL 4-PHENYL-2-OXO-BUTANOATE (FOBES) AS MFG. IN VENLO, THE NETHERLANDS PALMITIC ACID MANUFACTURED IN HYOGO, JAPAN. TRIPALMITIN AS MFG. IN HYOGO, JAPAN 2,2'-(ETHYLENEDIIMINO) DIBUTYRIC ACID AS MFG. IN SAINT LOUIS, MISSOURI

FACILITIES AND PROCEDURES ON N. 4OTH STREET IN BIRMINGHAM, ALABAMA 6-APA ANTIBIOTIC INTERMEDIATE AS MFG. IN HOSHIARPUR, PUNJAB, INDIA 7-ADCA ANTIBIOTIC INTERMEDIATE AS MFG. IN HOSHIAPUR, PUNJAB, INDIA CAPTOPRIL AS MFG. IN SHANDONG, PEOPLE'S REPUBLIC OF CHINA MEDICAL GRADE PACKAGING MATERIAL MANUFACTURED IN MOUNTAINTOP, PENNSYLVANIA. FACILITIES, PERSONNEL AND EQUIPMENT IN ILLERTISSEN, GERMANY FACILITIES AND PROCEDURES IN TAMPERE, FINLAND FACILITIES FOR ANALYSES OF DRUGS IN PAINESVILLE OHIO MARVAL M-PE 51 NATURAL AS MFG IN MAMARONECK, NEW YORK MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN IWATE PREFECTURE, JAPAN. TIN ETHYL ETIOPURPURIN (TEP) EMULSION PROCESSING IN KUNGSANGEN AND STOCKHOLM, SWEDEN DOTHIEPIN HYDROCHLORIDE AS MFG IN CRAMLINGTON, NORTHUMBERLAND,ENGLAND MONTANIDE ISA 708 AS MFG IN CASTRES, FRANCE MONTANIDE ISA 51 VG 7-AMINODESACETOXY CEPHALOSPORANIC ACID (7-ADCA) MFG IN MEXICO, MISSOURI CEPHALOSPORIN G MFG IN MEXICO, MISSOURI PENICILLIN G SULFOXIDE MFG IN MEXICO, MISSOURI

SMITHKLINE BEECHAM PHARMACEUTICALS AURANOFIN AS MFG. CARRIGALINE, CO. CORK, IRELAND BY PENN CHEMICALS

NOBEL CHEMICALS AB DIV FINE CHEMICALS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING INC PROCEDURES OF LIDOCAINE AND LIDOCAINE BASE.

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4Q2012EXCEL DMF# 9761 I 9762 A 9763 9764 I 9765 9766 9767 9768 A 9769 9770 9771 9772 9773 9774 9775 9776 9777 9778 I 9779 9780 9781 9782 9783 9784 I 9785 9786 9787 I 9788 I 9789 I 9790 A 9791 9792 9793 A I I II III II 7/22/1992 7/23/1992 6/24/1992 PIRAMAL HEALTHCARE LTD 3M PHARMACEUTICALS ISOCHEM SA II 7/20/1992 BIOVECTRA INC II 3/20/1992 TOYO KASEI KOGYO CO LTD I 7/17/1992 YAMANOUCHI PHARMACEUTICAL CO LTD A I II II II 7/21/1992 6/30/1992 7/21/1992 I I A I I III III II II I III 6/15/1992 6/15/1992 7/14/1992 7/15/1992 6/19/1992 7/14/1992 I I I I A I I I I II II III II II I III I II III 7/8/1992 7/15/1992 3/6/1992 7/13/1992 7/13/1992 7/10/1992 7/8/1992 7/10/1992 7/10/1992 7/17/1992 GEDEON RICHTER LTD MEDICHEM SA BASF AKTIENGESELLSCHAFT SCHERING AG PFIZER INC SANOFI CHIMIE MOLD-RITE PLASTICS INC YAMASA CORP YAMASA SHOYU CO LTD DSM MARKETING CENTRE CHEMICALS AND POLYMERS BASF AKTIENGESELLSCHAFT BASF AKTIENGESELLSCHAFT HOVIONE FARMACIENCIA SA HOVIONE SOCIEDADE QUIMICA SA CHANGZHOU PHARMACEUTICAL FACTORY CORNING INC SCIENCE PRODUCTS DIVISION SANOFI CHIMIE FINE CHEMICALS CORPORATION HAARMANN AND REIMER GMBH I A I II II II II 7/7/1992 6/23/1992 6/23/1992 6/23/1992 HAUSER CHEMICAL RESEARCH INC EVONIK TECHNOCHEMIE GMBH DEGUSSA AG PEDIATRIC PHARMACEUTICALS INC A III I 6/25/1992 7/6/1992 II 7/2/1992 RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA SPA DOW CHEMICAL CO CHIRON BV STATUS Type SUBMIT DATE II 6/30/1992 HOLDER KOEI CHEMICAL CO LTD SUBJECT

4Q2012

HYD [2-HYDROXYMETHYL-3-METHYL-4-(2,2,2-TRIFLUOROETHOXY PYRIDINE] MFG IN OSAKA, JAPAN DOBUTAMINE HYDROCHLORIDE MFG. IN LATINA, ITALY DFDB-1085 NATURAL 7 MFG IN BOUND BROOK, NEW JERSEY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN AMSTERDAM , THE NETHERLANDS. TAXOL MANUFACTURED IN BOULDER, COLORADO. LISINOPRIL (TFA)-ETHYLESTER MANUFACTURED IN HANAU, GERMANY. LISINOPRIL (TFA)-ETHYLESTER AS MANUFACTURED IN HANAU, GERMANY. THALIDOMIDE TABLETS MANUFACTURED IN LEXINGTON, MA AND IOWA CITY, IA FOR PEDIATRIC PHARMACEUTICALS INC. CIMETIDINE HYDROCHLORIDE AS MFG. IN DOROG AND BUDAPEST, HUNGARY CAPTOPRIL AS MFG IN GERONA, SPAIN TERLUX KR 2804 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY HYDROXY ACID MANUFACTURED IN BERLIN, GERMANY. HYDROXY ACID AS MANUFACTURED IN KALAMAZOO MANUFACTURING FACILITIES AT NOTRE DAME DE BONDEVILLE, FRANCE PACKAGING MATERIALS MANUFACTURED IN PLATTSBURGH, NEW YORK. FACILITIES FOR THE MANUFACTURE OF ADENOSINE ADENOSINE AS MFG IN CHIBA-KEN, JAPAN SFC34-ON AS MFG. IN BEEK, THE NETHERLANDS. LUPOLEN 2414 F AS MFG IN WESSLING, GERMANY LUPOLEN 2424 F AS MFG IN WESSLING GERMANY CLOBETASOL 17-PROPIONATE MFG. IN LISBON PORTUGAL BECLOMETHASONE 17,21-DIPROPIONATE MONOHYDRATE MFG IN LISBON, PORTUGAL FACILITY FOR THE MANUFACTURE OF METHACYCLINE PYREX BOROSILICATE GLASSES FOR LABORATORY AND PHARMACEUTICAL APPLICATIONS HYDROXY ACID AS MANUFACTURED IN VERTOLAYE, FRANCE MEXILETINE HYDROCHLORIDE AS MANUFACTURED A CAPE PROVINCE, SOUTH AFRICA NEO HELIOPAN TYPE 303 (OCTOCRYLENE) MANUFACTURED IN HOLZMINDEN, GERMANY MANUFACTURE, PROCESSING, PACKAGING, AND STORING OF BULK DRUG SUBSTANCE A TAKAHAGI IBARAKI 318, JAPAN DIMETHYLAMINOTHIOACETAMIDE HYDROCHLORIDE MANUFACTURED IN TAKASAGOCITY, HYOGO, JAPAN ENZYME ADENOSINE DEAMINASE AS MANUFACTURED IN CHARLOTTETOWN, P.E.I. CANADA ISOFLURANE AS MANUFACTURED IN AVONMOUTH, BRISTOL, THE UNITED KINGDOM #9831 POLYURETHANE LAMINATE AS MANUFACTURED INBROOKINGS, SD MICONAZOLE NITRATE AS MFG. IN GENNEVILLIERS, FRANCE

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4Q2012EXCEL DMF# 9794 9795 9796 I 9797 I 9798 9799 9800 9801 I 9802 9803 9804 9805 I 9806 9807 9808 I 9809 I 9810 9811 I 9812 I 9813 I 9814 I 9815 I 9816 I 9817 I 9818 I 9819 9820 I 9821 9822 A I II IV 8/14/1992 8/14/1992 I I I 8/17/1992 8/11/1992 YAMANOUCHI PHARMACEUTICAL CO LTD MANUFACTURING FACILITIES LOCATED IN IWATE-KEN 028-71, JAPAN. III 8/10/1992 AMOCO CHEMICAL SA III 8/10/1992 AMOCO CHEMICAL SA II 8/14/1992 SYNTHELABO PHARMACIE II 8/25/1992 SIANG TA PHARMACEUTICAL CO LTD II 8/10/1992 NIPPON KAYAKU CO LTD III 8/3/1992 BASELL POLIOLEFINE ITALIA SPA I 8/5/1992 GRUENTHAL I II II 8/14/1992 8/5/1992 ELEOS INC GRUNENTHAL GMBH II 8/3/1992 K-V PHARMACEUTICAL COMPANY A I II II I 8/3/1992 8/7/1992 8/13/1992 I I A II III II II 7/22/1992 8/10/1992 8/6/1992 5/7/1992 BIOCHIMICA OPOS 2 SPA AVERY DENNISON CHEMICAL DIV BIO RAD LABORATORIES INC BUNGE PARTY LTD SCIENTIFIC TECHNICAL SERVICES DIV SIFAVITOR SRL NORAMCO DELAWARE INC DR FRANZ KOHLER CHEMIE GMBH I I I II II II I 7/11/1990 7/11/1990 7/11/1990 7/22/1992 TEVA PHARMACEUTICALS INC BIOCRAFT LABORATORIES INC BIOCRAFT LABORATORIES INC BIOCHIMICA OPOS 2 SPA I 7/30/1992 STATUS Type SUBMIT DATE I I II II II 7/22/1992 7/14/1992 7/29/1992 HOLDER RHONE-POULENC INCORPORATED FINE CHEMICALS CORP LTD RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA SYNTEX FP INC SUBJECT ORUVAIL 200 MG. CAPSULES AS MFG. IN DAGENHAM, ESSEX, ENGLAND

4Q2012

PROCHLORPERAZINE MESYLATE AS MFG. IN CAPE PROVINCE, SOUTH AFRICA GEMFIBROZIL AS MFG. IN LATINA, ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GROVE CITY, OHIO. PARAHYDROXY DANE SALT MANUFACTURED IN MEXICO, MISSOURI 6-AMINOPENICILLANIC ACID MANUFACTURED IN MEXICO, MISSOURI D-(ALPHA)-DANE SALT MANUFACTURED IN MEXICO, MISSOURI MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF BUSPIRONE HYDROCHLORIDE IN MILAN, ITALY. BUSPIRONE HYDROCHLORIDE MANUFACTURED IN MILAN, ITALY. AS-2533 ADHESIVE MANUFACTURED IN MILL HALL, PENNSYLVANIA. MP50 EPOXIDE, UNDISTILLED, SIZED AS MFG. IN RICHMOND, CALIFORNIA CRUDE BLEOMYCIN (INTERMEDIATE) AS MFG IN PARKVILLE, VICTORIA, AUSTRALIA. CLOTRIMAZOLE AS MFG. IN MILAN, ITALY TRAMADOL HYDROCHLORIDE AS MFG. IN WILMINGTON, DELAWARE FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES LOCATED IN ALSBACK-HAHNLEIN, FEDERAL REPUBLIC OF GERMANY CETIRIZINE HYDROCHLORIDE/PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDEDRELEASE CAPSULES, 10MG/240MG AS MANUFACTURED IN ST. LOUIS MISSOURI. NUMBER OL(1)P53 AS MANUFACTURED IN FOSTER CITY,CA. TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN AACHEN, FEDERAL REPUBLIC OF GERMANY. FACILITY FOR THE MANUFACTURE OF TRAMADOL HYDROCHLORIDE IN AACHEN, FEDERAL REPUBLIC OF GERMANY LUPOLEN 1840 D AS MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY. BOC-AHPBA-OH, INTERMEDIATE OF DRUG SUBSTANCE AS MANUFACTURED IN KITA-KU, TOKYO, JAPAN. SODIUM STARCH GLYCOLATE AS MANUFACTURED IN HU-KUO HSINCHU, TAIWAN, THE REPUBLIC OF CHINA. 40% AQUEOUS SOLUTION OF L-ORNITHINE AS MANUFACTURED IN MONTARGIS CEDEX FRANCE. POLYPROPYLENE AMOCO PP 128-50109 AS MANUFACTURED IN GENEVA SWITZERLAND. POLYPROPYLENE AMOCO PP 110-50109 AS MANUFACTURED IN GENEVA SWITZERLAND.

CIBA PHARMACEUTICAL CO DIV CIBA GEIGY MANUFACTURING FACILITIES LOCATED IN HORSHAM, ENGLAND. CORP WYCKOFF CHEMICAL CO INC PSEUDOEPHEDRINE HYDROCHLORIDE MANUFACTURED IN SOUTH HAVEN, MICHIGAN. COLORCON ETHYLCELLULOSE DISPERSIONS FOR DRUG APPLICATIONS AS MANUFACTURED IN INDIANAPOLIS, INDIANA.

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4Q2012EXCEL DMF# 9823 9824 I 9825 9826 I 9827 9828 9829 A 9830 9831 9832 9833 9834 9835 I 9836 9837 9838 9839 9840 9841 A 9842 I 9843 9844 9845 9846 9847 9848 9849 9850 I 9851 9852 9853 I 9854 9855 9856 I A I II I III 9/1/1992 9/2/1992 9/2/1992 I I III II I 8/24/1992 8/31/1992 9/1/1992 I A I I I I I I II II III II II II II 8/31/1992 8/28/1992 8/31/1992 8/28/1992 8/28/1992 9/3/1992 9/1/1992 9/4/1992 WACKER CHEMIE GMBH KONGO CHEMICAL CO LTD CELSUS LABORATORIES INC BOSTIK INC BRISTOL MYERS SQUIBB COMPANY PENTAPHARM LTD BASLE BACHEM INC DSM PHARMA CHEMICALS SOUTH HAVEN INC BASELL POLIOLEFINE ITALIA SPA ANDRULIS RESEARCH CORP IV 7/28/1992 ROBERTET FLAVORS I A I C I I II II II II II 8/24/1992 8/20/1992 8/15/1992 7/27/1992 8/21/1992 8/31/1992 MEIJI SEIKA KAISHA LTD RESOLUTION CHEMICALS LIMITED SYNCHEM CHEMICALS PVT LTD FDC LTD WYCKOFF CHEMICAL CO INC 3M PHARMACEUTICALS I A I I A II II III III IV I 7/22/1992 8/19/1992 8/4/1992 8/4/1992 8/24/1992 8/15/1992 QUIMICA SINTETICA SA MILLIPORE CORP SOLVAY AND CIE SA SOLVAY SA SUDZUCKER AG SYNCHEM CHEMICALS PVT LTD I I II III II 8/25/1992 8/17/1992 8/14/1992 ALBEMARLE CORP AMPACET CORP BAYER PHARMA AG I III I 8/7/1992 8/25/1992 AMPACET CORP ALBEMARLE CORP STATUS Type SUBMIT DATE I III I 8/7/1992 8/14/1992 HOLDER AMPACET CORP LYNX THERAPEUTICS INC SUBJECT 10781 PE AS MANUFACTURED IN TARRYTOWN, N.Y. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FOSTER CIY, CALIFORNIA. 10007 PEMB AS MANUFACTURED IN TARRYTOWN, N.Y. MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN THANN, FRANCE. 2-BROMO-6-METHOXYNAPHTHALENE AS MFG. IN THANN, FRANCE 16666 BLUE PEMB AS MFG. IN TARRYTOWN, NEW YORK.

4Q2012

TRASYLOL (APROTININ) DRUG PRODUCT (ESUB) AS MANUFACTURED IN LEVERKUSEN, GERMANY LORATIDINE AS MFG. IN MADRID, SPAIN. VIRESOLVE FILTER MEMBRANE AS MFG. IN BEDFORD MASSACHUSETTS. ELTEX P KS 400 AS MFG. IN SARRALBE, FRANCE ELTEX P KL 104 AS MANUFACTURED IN SARRALBE, FRANCE ISOMALT AS MFG. IN OBRIGHEIM/PFALZ GERMANY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ANKLESHWAR GUJARA, INDIA. FACILITY AND PROCEDURES AT THE KITAKAMI PLANT. BACLOFEN AS MFG IN HERTS ENGLAND. METOPROLOL TARTRATE AS MFG IN ANKLESHWAR GUJARATINDIA TIMOLOL MALEATE AS MFG. IN MAHARASHTRA STATE, INDIA FLURBIPROFEN AS MFG. IN SOUTH HAVEN, MICHIGAN ESTRADIOL TRANSDERMAL DRUG DELIVERY SYSTEM AS MFG. IN ST. PAUL, MINNESOTA AND NORTHRIDGE, CALIFORNIA SPRAY DRIED ARTIFICIAL CHERRY FLAVOR AS MFG. IN SOUTH PLAINFIELD, NEW JERSEY FACILITIES AND PROCEDURES IN BURGHAUSEN, GERMANY CARBINOXAMINE MALEATE AS MANUFACTURED IN TOYAMA-KEN, JAPAN HEPARIN PEPTIDOGLYCAN AS MFG. IN CINCINNATI, OHIO HOT MELT ADHESIVE 235-334 TRIAMCINOLONE HEXACETONIDE AS MFG. IN HUMACAO, PUERTO RICO PEFABLOC SC AS MFG. IN BASLE, SWITZERLAND MSI-78 AS MFG. IN TORRANCE AND SAN DIEGO, CALIFORNIA HYDROXYUREA AS MFG. IN SOUTH HAVEN, MICHIGAN LUPOLEN 5261 ZQ 445 AS MFG. IN WESSELING, FEDERAL REPUBLIC OF GERMANY CIS-PLATIN (NSC-119875) AS MFG. IN BELTSVILLE, MARYLAND

SMITHKLINE BEECHAM PHARMACEUTICALS MANUFACTURING SITE, FACILITIES, PESONNEL, AND GENERAL OPERATING PROCEDURES IN WEST SUSSEX, ENGLAND. NV ORGANON ROCURONIUM BROMIDE AS MFG. IN OSS, THE NETHERLANDS CHANTAL PHARMACEUTICAL CORP 3M PHARMACEUTICALS FACILITIES AND PROCEDURES IN KAISERSLAUTERN, GERMANY #MSP 082592P DOUBLE COATED POLYETHYLENE TAPE AS MFG. IN BROOKINGS, SOUTH DAKOTA

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4Q2012EXCEL DMF# 9857 I 9858 9859 A 9860 9861 I 9862 9863 9864 9865 9866 I 9867 9868 9869 A 9870 9871 I 9872 9873 9874 I 9875 9876 A 9877 I 9878 9879 I 9880 9881 I 9882 9883 9884 I 9885 9886 I I III II 10/1/1992 4/15/1987 3M PHARMACEUTICALS DAIICHI SANKYO PROPHARMA CO LTD I I IV II III 9/28/1992 9/25/1992 10/1/1992 INTERCAPS SPOL SRO VIOBIN CORP 3M PHARMACEUTICALS I II II 9/25/1992 9/18/1992 GANES CHEMICALS INC SCICLONE PHARMACEUTICALS A III I 9/25/1992 9/4/1992 NOVA CHEMICALS CORP SOLVAY FLUOR AND DERIVATE GMBH III 9/29/1992 SPARTECH POLYCOM I II II 9/24/1992 9/22/1992 NIPPON KAYAKU CO LTD ACS DOBFAR SPA I I III II II 9/18/1992 9/14/1992 9/15/1992 KOLACK AG ROHNER AG PHARMAZELL GMBH I II I 9/7/1992 9/11/1992 FERMTEC PROCHIM SA UNION QUIMICO FARMACEUTICA SA I A II III III 8/8/1992 9/9/1992 9/8/1992 JOHNSON MATTHEY INC ST GOBAIN DESJONQUERES SA SGD REXAM HEALTHCARE A I I I III III III II I 9/3/1992 8/31/1992 9/3/1992 9/14/1992 9/14/1992 WALTER DRAKE INC FINDLEY ADHESIVES INC PRENT CORP JAPAN ENERGY CORP JAPAN ENERGY CORP I III II 9/11/1992 9/8/1992 A III V 9/2/1992 9/3/1992 3M DRUG DELIVERY SYSTEMS INTERNATIONAL PHARMACEUTICAL AEROSOL CONSORTIUM TOXICOLOGY TESTING JL CLARK DIV ATLAS TUBE BAYER AG #1777 POLYOLEFIN FOAM TAPE AS MFG. IN BROOKINGS, SOUTH DAKOTA STATUS Type SUBMIT DATE III 9/2/1992 HOLDER 3M DRUG DELIVERY SYSTEMS SUBJECT

4Q2012

#MSP 082492P POLYETHYLENE TAPE MANUFACTURED IN BROOKINGS, SOUTH DAKOTA.

TOXICOLOGY AND PHARMACOKINETICS DATA ON THE HYDROFLUOROALKANE HFA134A. COLLAPSIBLE ALUMINUM TUBES MANUFACTURED IN DOWNERS GROVE, ILLINOIS. BAY Y 3118 DRUG SUBSTANCE AS MFG. IN WUPPERTAL, FEDERAL REPUBLIC OF GERMANY. THERMFORMED PLASTIC STRIPS AS MFG IN HOLYOKE MASSACHUSETTS. HOT MELT ADHESIVE 694-373 24 UNIT RU-TUSS DE ARRAY MANUFACTURED IN JANESVILLE, WISCONSIN. KNI-272 AS MFG BY BIOSCIENCE RESEARCH LABORATORIES IN SAITAMA, JAPAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SAITAMA, JAPAN. BAHNH (CYTOGEN LINKER) MANUFACTURED IN WEST DEPTFORD, NEW JERSEY. AMBER GLASS CONTAINERS AS MFG IN FRANCE. THERMOPLASTIC CLOSURES & SPECIALTY ITEMS MANUFACTURED IN BROOKVILLE, PENNSYLVANIA METHACYCYLINE HYDROCHLORIDE MANUFACTURED IN VARESE, ITALY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BARCELONA, SPAIN. INTERNAL COATING 3123 MANUFACTURED IN KALTBRUNN, SWITZERLAND. PHENAZOPYRIDIINE HYDROCHLORIDE MANUFACTURED IN PRATEIN,SWITZERLAND. L-LYSINE-N-ACETYLCYSTEINATE MANUFACTURED IN RAUBLING, FEDERAL REPUBLIC OF GERMANY. AUREOBASIDIN A AS MFG.. IN TAKASAKI AND IN TOKYO, JAPAN. O-FORMYL CEFAMANDOLE ACETONITRILE SOLVATE MANUFACTURED INTRIBIANO, ITALY. D19971 WHITE POLYPROPYLENE CONCENTRATE MANUFACTURED IN DONORA, PENNSYLVANIA. POLYETHYLENE RESINS AS MFG. IN ONTARIO, CANADA MANUFACTURING SITE, FACLITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF 1,1,2,3,3,3-HEPTAFLUOROPROPANE IN FRANKFURT, GERMANY. GEMFIBROZIL MANUFACTURED IN CARLSTADT AND PENNSVILLE, NEW JERSEY. THYMOSIN ALPHA 1 INJECTION FINAL DOSAGE FORM AS MFG. IN FOSTER CITY, CALIFORNIA EMPTY HARD GELATIN CAPSULES AS MFG IN ZLIN, CZECH REPUBLIC VIOKASE AS MFG. IN MONTICELLO, ILLINOIS #MSP 081792P POLYOLEFIN FOAM TAPE MANUFACTURED IN BROOKINGS, SOUTH DAKOTA. #9751 POLYOLEFIN FOAM TAPE MANUFACTURED IN BROOKINGS, SOUTH DAKOTA. CS-807 CEFPODOXIME PROXETIL DRUG SUBSTANCE MANUFACTURED IN ODAWARA, JAPAN (PREVIOUSLY ANTIBIOTIC FILE).

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4Q2012EXCEL DMF# 9887 I 9888 I 9889 9890 9891 I 9892 9893 I 9894 9895 I 9896 9897 I 9898 I 9899 9900 9901 9902 9903 9904 9905 9906 9907 I 9908 9909 I 9910 I 9911 I 9912 9913 9914 I 9915 9916 9917 I A A II II II 10/21/1992 10/12/1992 10/21/1992 PEPTISYNTHA SA IPCA LABORATORIES LTD MALLINCKRODT INC I I II II I 10/16/1992 9/29/1992 10/8/1992 3M PHARMACEUTICALS HYDRO MED SCIENCES VALOIS II 9/24/1992 PHARMACIE CENTRALE DE FRANCE II 10/13/1992 LAPORTE INDUSTRIES LTD I II III 10/14/1992 10/14/1992 ASAHI KASEI FINECHEM CO LTD TENAX CORP A A I I I I A A II III III III III III III II I 10/5/1992 10/8/1992 10/5/1992 10/5/1992 10/5/1992 10/5/1992 10/1/1992 10/9/1992 10/14/1992 SYN TECH CHEM AND PHARM CO LTD 3M DRUG DELIVERY SYSTEMS WEST PENN PLASTIC INC WEST PENN PLASTIC INC WEST PENN PLASTIC INC WEST PENN PLASTIC INC ST GOBAIN DESJONQUERES SA SGD NOVARTIS PHARMA AG ASAHI CHEMICAL INDUSTRY CO LTD II 10/5/1992 I I I 10/5/1992 9/30/1992 OTSUKA PHARMACEUTICAL CO., LTD. CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE LTD. STAVO INDUSTRIES INC I I II 8/21/1992 9/25/1992 OTSUKA PHARMACEUTICAL CO., LTD. ATI DIV PYMAH CORP I II II 9/30/1992 9/30/1992 LIFE TECHNOLOGIES INC LIFE TECHNOLOGIES INC HYBRIDOMA SFM AS MFG. IN GRAND ISLAND, NEW YORK I I II II II 9/21/1992 9/30/1992 9/19/1992 ELANCO QUIMICA LIMITADA LIFE TECHNOLOGIES INC FREEDOM CHEMICAL DIAMALT GMBH CEPHALEXIN DISOLVATE MANUFACTURED IN SAO PAULO, BRAZIL. CHO-S-SFM AND CHO-S-SFMII AS MFG. IN GRAND ISLAND, NEW YORK II 10/2/1992 STATUS Type SUBMIT DATE II 9/3/1982 HOLDER SANKYO CO LTD SUBJECT

4Q2012

CEFMETAZOLE (FREE ACID) MANUFACTURED IN ODAWARA, JAPAN. PREVIOUSLY AN ANTIBIOTIC FILE HUHTAMAKI OY LEIRAS PHARMACEUTICALS DOBUTAMINE HYDROCHLORIDE MANUFACTURED IN TURKU, FINLAND.

METOPROLOL TARTRATE AS MFG. IN RAUBLING, THE FEDERAL REPUBLIC OF GERMANY

SF-900 SERUM-FREE INSECT CELL CULTURE MEDIUM AS MFG. IN GRAND ISLAND, NEW YORK FACILITIES AND OPERATING PROCEDURES AT THE SAGA FACTORY, JAPAN POTASSIUM DICHROMATE, POTASSIUM HYDROFIDE, UREA (STERILIZATION PROCESS INDICATORS COMMERCIAL BULK PLANT OF SECOND TOKUSHIMA FACTORY IN TOKUSHIMA, JAPAN FACILITY FOR THE MANUFACTURE OF GALANTHAMINE HYDROBROMIDE IN SOFIA, BULGARIA PHARMACEUTICAL GRADE DEPTH TYPE FILTER MEDIA MANUFACTURED IN KINGSTON, NEW YORK. DICLOFENAC SODIUM MANUFACTURED IN HSIN YING, TAIWAN, REPUBLIC OF CHINA. #1779 POLYOLEFIN FOAM TAPE MANUFACTURED IN BROOKINGS, SOUTH DAKOTA. 25 TABLET DISPENSER AS MFG. IN NEW CASTLE PENNSYLVANIA. DOSAGE CUP PP FOR TRIAMINIC LIQUIDS AS MFG. IN NEW CASTLE, PENNSYLVANIA. 28 TABLET DISPENSER MANUFACTURED IN NEW CASTLE, PENNSYLVANIA. 21 TABLET DISPENSER AS MFG. IN NEW CASTLE, PENNSYLVANIA. TITAN 300 TREATED CONTAINERS AS MFG. IN FRANCE. PENTETREOTIDE AS MFG. IN SWITZERLAND MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF ORACIL IN NOBEOKA CITY, JAPAN. URACIL AS MFG. IN NOBEOKA CITY, JAPAN. PACKAGING MATERIALS MANUFACTURED IN YOUNGSVILLE AND CARY, NORTH CAROLINA AND DANBURY, CONNECTICUT. LAPONITE D, DS, XLG, XLS, AND DF PRODUCTS AS MFG. IN CHESHIRE, UNITED KINGDOM. BISMUTH SUBSALICYLATE AND SODIUM BICARBONATE 2 PER THOUSAND AS MFG. IN LA VOULTE SUR RHONE, FRANCE. PERFLUORODICHLOROOCTANE AS MFG. IN ST. PAUL, MINNESOTA HISTRELIN (LHRH AGONIST) IMPLANTS AS MFG. IN NEW BRUNSWICK, NEW JERSEY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LE VAUDREUIL, FRANCE. EPTIFIBATIDE (BULK) AS MFG. IN BRUSSELS BELGIUM. PYRANTEL TARTRATE AS MFG. IN BOMBAY, INDIA OCTREOSCAN REACTION VIAL, PENETREOTIDE LYPHOLIZED AS MFG. IN THE PETTEN FACILITY IN THE NETHERLANDS.

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4Q2012EXCEL DMF# 9918 A 9919 A 9920 9921 9922 9923 9924 9925 9926 A 9927 9928 I 9929 I 9930 9931 9932 9933 9934 9935 9936 I 9937 9938 9939 9940 I 9941 A 9942 9943 9944 9945 9946 9947 9948 9949 9950 9951 A A I I I I I A A A II III III III III III III III III II 11/6/1992 10/13/1992 10/13/1992 10/13/1992 10/13/1992 10/13/1992 10/12/1992 10/12/1992 10/13/1992 11/5/1992 PCAS BASF AKTIENGESELLSCHAFT BASF AKTIENGESELLSCHAFT BASF AKTIENGESELLSCHAFT BASF AKTIENGESELLSCHAFT BASF AKTIENGESELLSCHAFT STYROLUTION GMBH STYROLUTION GMBH BASF PIGMENT GMBH BACHEM AMERICAS INC II 10/28/1992 BIO RAD LABORATORIES INC I A I III III II II 11/3/1992 11/2/1992 11/2/1992 10/28/1992 SHIN ETSU CHEMICAL IND CO LTD TUSA SA SANOFI SYNTHELABO INC. BIORAD CHEMICAL DIV I I A I I I II II II II II II I 10/30/1992 11/2/1992 10/28/1992 11/2/1992 10/30/1992 10/29/1992 10/28/1992 I 10/24/1992 I II II 10/27/1992 10/23/1992 ERREGIERRE SPA LIFE TECHNOLOGIES INC I I I A I A III III I II III II II 9/28/1992 10/23/1992 9/24/1992 10/23/1992 10/23/1992 10/27/1992 10/28/1992 ROLLPRINT PACKAGING PRODUCTS INC HAENDLER AND NATERMANN GMBH PHARMACIE CENTRALE DE FRANCE SEKISUI MEDICAL CO LTD ROLLPRINT PACKAGING PRODUCTS INC TEVA PHARMACEUTICAL INDUSTRIES LTD E BEGEROW GMBH AND CO II 10/21/1992 MALLINCKRODT INC STATUS Type SUBMIT DATE II 10/21/1992 HOLDER MALLINCKRODT INC SUBJECT

4Q2012

OCTREOSCAN REACTION VIAL (ESUB) MANUFACTURED IN MARYLAND HEIGHTS, MISSOURI. INDIUM IN-111 CHLORIDE STERILE SOLUTION (ESUB) AS MANUFACTURED IN MARYLAND HEIGHTS, MISSOURI. RPP #31-1003 PACKAGING MATERIAL AS MFG. IN ADDISON ILLINOIS. FORMABLE FILM FOIL COMBINATIONS AS MFG. IN GERMANY. FACILITY IN LA VOULTE SUR RHONE, FRANCE N-ACETYL-DL-TRYPTOPHAN AS MFG. IN IWATE PREFECTURE, JAPAN. RPP #26-1072 PACKAGING MATERIAL AS MFG. IN ADDISON, ILLINOIS. VECURONIUM BROMIDE AS MFG. IN RHO, ITALY FILTRATION MEDIA FOR PURIFICATION OF PHARMACEUTICAL PRODUCTS AS MFG IN LANGENLONSHEIM, GERMANY LABETALOL HYDROCHLORIDE AS MFG. IN BERGAMO, ITALY.

SF-900 II SFM (OPTIMIZED SERUM-FREE MEDIUM FOR INSECT CELL CULTURE, COMPLETE) CARACO PHARMACEUTICAL LABORATORIES FACILITY IN DETROIT, MICHIGAN. LTD SANDOZ PHARMACEUTICALS CORP SDZ PSC 833 AS MFG. IN BASLE, SWITZERLAND SIGMA F AND D DIV LTD NIHON SURFACTANT KOGYO KK MILLIPORE CORPORATION FUKUZYU PHARMACEUTICAL CO LTD CHONGQING NO. 5 PHARM. FACTORY EASTMAN CHEMICAL CO TESTOSTERONE AS MFG. IN ST. LOUIS, MISSOURI HCO-60 MANUFACTURED IN UTSUOMIYA, JAPAN. MILLIPAK 20 FILTER UNIT MANUFACTURED IN JAFFREY, NEW HAMPSHIRE. NAPHAZOLINE HYDROCHLORIDE MANUFACTURED IN TOYAMA CITY, JAPAN. METHAZOLAMIDE AS MFG. IN CHONGQING, SICHUAN, PEOPLE'S REPUBLIC OF CHINA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF HOT MELT ADHESIVES IN LONGVIEW, TEXAS. X-70-201 FLUOROSILICONE RELEASE MATERIAL AS MFG. IN TOKYO JAPAN. ALUMINUM TUBES PACKAGING MATERIAL AS MFG. IN VEVEY SWITZERLAND. NADROPARIN CALCIUM AS MFG. IN NOTRE-DAME DE BONDEVILLE, FRANCE. MACRO-PREP HIGH S STRONG CATION EXCHANGE SUPPORT AS MFG. IN RICHMOND CALIFORNIA. MACRO-PREP HIGH Q STRONG ANION EXCHANGE SUPPORT AS MFG. IN RICHMOND, CALIFORNIA. MOEXIPRIL HYDROCHLORIDE AS MFG. IN SWITZERLAND AND IRELAND. SICOLEN BROWN 32-1315 AS MFG. IN STUTTGART, GERMANY. SICOLEN BLUE 65-0475 AS MFG. IN STUTTGART, GERMANY. SICOLEN BLUE 66-0185 AS MFG. IN STUTTGART, GERMANY. SICOLEN BROWN 23-1195 MANUFACTURED IN STUTTGART, GERMANY. SICOLEN BROWN 32-1855 AS MFG. IN STUTTGART, GERMANY. TERLURAN 877 M GREY 76035 AND 35493 AS MFG. IN LUDWIGSHAFEN, GERMANY TERLURAN 877 M WHITE 00260 AS MFG. IN LUDWIGSHAFEN, GERMANY. SICOSTYREN WHITE 00-2105 AS MFG. IN STUTTGART, GERMANY. DES-AMINO(1)-D-ARGININE(8)-VASOPRESSIN (DDAVP) AS MFG. IN TORRANCE, CALIFORNIA

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4Q2012EXCEL DMF# 9952 9953 9954 9955 I 9956 I 9957 9958 9959 9960 9961 9962 9963 I 9964 9965 9966 9967 9968 9969 9970 9971 9972 A 9973 A 9974 I 9975 9976 9977 9978 9979 9980 9981 9982 9983 9984 9985 I I I I A I I I I A I I II II II II II III II II II I 11/17/1992 11/19/1992 11/18/1992 11/20/1992 11/19/1992 11/6/1992 11/30/1992 8/7/1972 3/20/1975 12/1/1992 11/17/1992 LIPHA SA BASF CORP ALDRICH CHEMICAL CO INC PARTICLE DYNAMICS INC SIGMA F AND D DIV LTD SHIN ETSU CHEMICAL IND CO LTD HELVOET PHARMA MARYLAND ASTELLAS PHARMA INC OLON SPA TRITON LABORATORIES PRIVATE LTD LIPHA SA I 11/25/1992 II 11/23/1992 PIERRE FABRE MEDICAMENT PRODUCTION/AQUITAINE PHARM INTERNATIONAL LABORATORIO BP SRL NAVELBINE FOR INJECTION MANUFACTURED IN IDRON, FRANCE. I I C I I I I I II IV II II II II II II II 11/17/1992 11/16/1992 11/20/1992 11/19/1992 11/13/1992 11/13/1992 11/6/1992 11/19/1992 11/25/1992 HOSPIRA INC AMERICAN MAIZE PRODUCTS CO TEVA PHARMACEUTICAL INDUSTRIES LTD FARCHEMIA SRL MALLINCKRODT INC ALDRICH CHEMICAL CO INC FAR RESEARCH INC WHATMAN PAPER LTD BACHEM SA I I I I I I II II II I IV II I 11/10/1992 11/13/1992 11/13/1992 11/13/1992 11/9/1992 11/2/1992 11/13/1992 GENZYME FINE CHEMICALS DAIICHI PURE CHEMICALS CO LTD DAIICHI PHARMACEUTICAL CO LTD DAIICHI PHARMACEUTICAL CO LTD AMERICAN MAIZE PRODUCTS CO BIHOKU FUNKA KOGYO CO LTD HAMILTON PHARMACEUTICAL LTD ACEBUTOLOL HYDROCHLORIDE AS MFG. IN SUFFOLK, ENGLAND. DF-4639 INTERMEDIATE AS MFG. IN TOKYO, JAPAN. DS-4152 DRUG SUBSTANCE AS MFG. IN TOKYO, JAPAN. PARENTERAL FORMULATION FACILITY IN OSAKA, JAPAN. MALTODEXTRIN AS MFG. IN HAMMOND, INDIANA. PRECIPITATED CALCIUM CARBONATE AS MFG. IN OKAYAMA, JAPAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HUMACAO, PUERTO RICO. PFC EMULSION MANUFACTURED IN CLAYTON, NORTH CAROLINA. TABLETING STARCH MANUFACTURED IN HAMMOND, INDIANA. ETOPOSIDE MANUFACTURED IN RHO, ITALY. CARBAMAZEPINE AS MFG. IN BERGAMO ITALY. LEVORPHANOL TARTRATE MANUFACTURED IN ST. LOUIS, MISSOURI. 1-HEXADECANOL MANUFACTURED IN MILWAUKEE, WISCONSIN. WAY-125,174 CRUDE AS MFG. IN PALM BAY, FLORIDA. IV 10/22/1992 STATUS Type SUBMIT DATE I I I III III I III 11/2/1992 11/6/1992 11/9/1992 11/6/1992 HOLDER ROLLPRINT PACKAGING PRODUCTS INC ROLLPRINT PACKAGING PRODUCTS INC URQUIMA SA AMERICAN RENOLIT CORPORATION LAPORTE FLAVORS NORTH AMERICA INC SUBJECT RPP #21-1046 PACKAGING MATERIAL MANUFACTURED IN ADDISON ,ILLINOIS. RPP #26-3009 PACKAGING MATERIAL AS MFG. IN ADDISON, ILLINOIS. FACILITIES AND OPERATING PROCEDURES IN BARCELONA, SPAIN. SOLMED 100 FILM AS MFG. IN LAPORTE, INDIANA

4Q2012

#827.052/EN NOR-CAP ARTIFICIAL CINNAMON FLAVOR AS MFG. IN NORTHFIELD ILLINOIS.

DE52/D461 ANION EXCHANGE CELLULOSE AS MFG. AND TESTED IN KENT, ENGLAND 5-AMINOLEVULINIC ACID HYDROCHLORIDE MANUFACTURED IN VIONNAZ, SWITZERLAND.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SIDERNO, ITALY. FACILITY AND OPERATING PROCEDURES IN SURESNES, FRANCE. UVINUL N539 SG AS MFG. IN RESSELATER, NEW YORK. PERCORTEN PIVALATE MANUFACTURED IN MILWAUKEE, WISCONSIN. DESTAB CALCIUM CARBONATE 95% MANUFACTURED IN ST. LOUIS, MISSOURI. L-ARGININE HYDROCHLORIDE MANUFACTURED IN SAINT LOUIS, MISSOURI. GADOLINIUM OXIDE MANUFACTURED IN TAKEFU, JAPAN. RUBBER CLOSURE FORMULATION 35004-50 RED AS MFG. IN SALISBURY MARYLAND. CEPHALOSPRIN C FERMENTATION AND RECOVERY INOSAKA, JAPAN. 7 AMINO CEPHALOSPORANIC ACID AS MFG. IN CORREZZANA, ITALY ACETAMINOPHEN MANUFACTURED IN HYDERABAD, INDIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CALAIS, FRANCE.

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4Q2012EXCEL DMF# 9986 I 9987 9988 9989 9990 9991 9992 9993 9994 I 9995 9996 I 9997 9998 9999 10000 I 10001 10002 I 10003 10004 10005 10006 10007 10008 10009 I 10010 10011 10012 10013 10014 10015 10016 10017 10018 10019 I 10020 I II 7/29/1992 JACOBUS PHARMACEUTICAL CO I I I I I I N I I I I I 12/20/1992 12/10/1992 12/28/1992 I II II II II II 12/16/1992 12/14/1992 12/16/1992 12/14/1992 12/14/1992 12/14/1992 ADVANCE BIOFACTURES CORP HEUMANN PHARMA GMBH AND COMPANY HOSPIRA INC CHISSO CORP CHISSO CORP CHISSO CORP NOT AN ASSIGNED NUMBER BIOCHIMICA OPOS 2 SPA CYTOSOL LABORATORIES INC LABORATORIOS SENOSIAIN SA DE CV FACILITIES AND PROCEDURES IN MILAN, ITALY FACILITY IN BRAINTREE, MASSACHUSETTS A I I A I I II II II II II I V 11/25/1992 12/15/1992 12/15/1992 12/15/1992 12/10/1992 12/6/1992 7/30/1990 ACS DOBFAR SPA SAFC BIOSCIENCES INC ALZA CORP FERMION OY BIO RAD LABORATORIES INC TATEYAMA KASEI CO LTD ASTELLAS PHARMA INC A II I 12/8/1992 12/10/1992 OLON SPA BOOTS COMPANY LTD MYCOPHENOLIC ACID AS MFG. IN TURIN, ITALY. I A I I II IV II 11/30/1992 11/26/1992 12/2/1992 12/9/1992 I II II 12/10/1992 12/4/1992 FERRING LABORATORIES INC BECTON DICKINSON PHARMACEUTICAL SYSTEMS JUZEN CHEMICAL COMPANY LTD FUKUZYU PHARMACEUTICAL CO LTD FLAVOR NORTH AMERICA INC A A I I I I I III III II II II II II II 7/10/1992 11/26/1992 11/25/1992 11/25/1992 11/25/1992 11/25/1992 11/25/1992 12/3/1992 EASTMAN CHEMICAL CO FLINT HILLS RESOURCES LP SIGMA CHEMICAL CO SIGMA F AND D DIV LTD SIGMA F AND D DIV LTD SIGMA F AND D DIV LTD SIGMA F AND D DIV LTD ALZA CORP STATUS Type SUBMIT DATE I 11/24/1992 HOLDER BRECON PHARMACEUTICALS LTD SUBJECT

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HAY-ON-WYE, HEREFORD, ENGLAND. EASTAR AND VORIDIAN POLYMER PRODUCTION AT TENNESSEE EASTMAN DIVISION POLYPROPYLENE MANUFACTURED IN LONGVIEW, TX L-METHIONINE AS MFG. IN SAINT LOUIS, MISSOURI. L-CYSTEINE MANUFACTURED IN SAINT LOUIS, MISSOURI. L-ISOLEUCINE MANUFACTURED IN ST. LOIUS, MISSOURI. L-THREONINE MANUFACTURED IN SAINT LOUIS, MISSOURI. L-PHENYLALANINE AS MFG. IN SAINT LOUIS, MISSOURI. CONTROLLED RELEASE FORMULATIONOF THE AMORPHOUS ERYTHROMYCIN ETHYLSUCCINATE MFG. IN MOUTAIN VIEW, CALIFORNIA. TERLIPRESSIN DRUG SUBSTANCE AS MFG. IN MALMO, SWEDEN. IONTOPHORETIC DELIVERY SYSTEM MANUFACTURED IN WEST CALDWELL, NEW JERSEY. FACILITIES AND OPERATING PROCEDURES IN TOYAMA CITY, JAPAN. PYRIMETHAMINE MANUFACTURED IN TOYAMA CITY, JAPAN. #862.170/EM NATURAL & ARTIFICIAL LEMON FLAVOR EMULSION.

AMAGASAKI CHEMICAL INDUSTRIES CO LTD FR084078 AS MFG. IN AMAGASAKI-CITY, HYOGO, JAPAN.

D95 MANUFACTURING FACILITY AND OPERATING PROCEDURES IN NOTTINGHAM, ENGLAND. SODIUM CARBONATE STERILE AS MFG. IN MILAN, ITALY. PF-11 MANUFACTURED IN DENVER, PENNSYLVANIA. GITS (VENLAFAXINE HYDROCHLORIDE) MFG. IN MOUNTAIN VIEW, CALIFORNIA CROMOLYN SODIUM MFG. IN ESPOO AND HANKO, FINLAND MACRO PREP METHYL HIC SUPPORT MFG. IN RICHMOND, CALIFORNIA KYUSYU PLANT IN TAGAWA CITY, JAPAN STERILE PROCESSING FACILITIES FOR CEFTIZOXIME SODIUM, STERILE (BULK) LOCATED IN TAKAOKA, JAPAN BIO-SPECIFIC N.V. FACILITY IN CURACAO, NETHERLANDS TRIMETREXATE BASE MFG. IN FEUCHT, GERMANY SPC-100270 EMULSION MFG. IN CLAYTON, NORTH CAROLINA HEPARIN - CELLUFINE B MFG. IN CHIBA, JAPAN AMINO - CELLUFINE MFG. IN CHIBA, JAPAN HEPARIN - CELLUFINE MFG. IN CHIBA, JAPAN

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CELAYA, GUANAJUATO, MEXICO. PYRIDOXAL ISONICOTINOYL HYDRAZONE DIHYDROCHLORIDE MFG. IN PLAINSBORO, NEW JERSEY

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4Q2012EXCEL DMF# 10021 10022 10023 10024 10025 A 10026 10027 10028 10029 10030 I 10031 10032 10033 A 10034 10035 10036 10037 10038 10039 I 10040 10041 10042 10043 I 10044 A 10045 10046 10047 A 10048 10049 10050 I 10051 I 10052 10053 I I II III 12/9/1992 1/20/1993 III 1/18/1993 I A I III III 1/21/1993 2/12/1993 1/19/1993 ARCHIMICA SPA LANXESS CORP ABSORBENT COTTON CO FACILITY IN ORIGGIO (VARESE), ITALY POCAN B1501 NATURAL AS MFG. IN LEVERKUSEN, GERMANY I A II II III 1/13/1993 1/19/1993 1/8/1993 II 1/12/1993 RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA SPA NORDIC SYNTHESIS AB URQUIMA SA TICONA LLC ACYCLOVIR AS MFG. IN LATINA, ITALY KETOPROFEN AS MFG. IN KARLSKOGA, SWEDEN GLIPIZIDE AS MFG. IN BARCELONA, SPAIN A A I II II II III 1/15/1993 1/13/1993 1/22/1993 1/12/1993 TANAKA KIKINZOKU KOGYO PHARMACIA AND UPJOHN INC NIPPON KAYAKU CO LTD BOREALIS GROUP I A I A I III II II II II I 10/14/1993 1/11/1993 12/30/1992 1/15/1993 1/15/1993 1/15/1993 MULTISORB TECHNOLOGIES INC CU CHEMIE UETIKON GMBH ARENOL CHEMICAL CORP JANSSEN PHARMACEUTICA NV JANSSEN RESEARCH FOUNDATION TANAKA KIKINZOKU KOGYO I N III 1/11/1993 I 12/11/1992 SPAN CONTRACT PACKAGING INC NOT AN ASSIGNED NUMBER TICONA GMBH I I A I I II II II II 12/30/1992 12/30/1992 12/30/1992 1/4/1993 1/5/1993 STATUS Type SUBMIT DATE I I I I III II III IV II 12/29/1992 12/16/1992 12/18/1992 12/21/1992 12/28/1992 HOLDER NALGE CO JACOBUS PHARMACEUTICAL CO RICHARDS PACKAGING INC ALEX FRIES VEGEFLORA EXTRACOES DO NORDESTE LTDA GENESIS INDUSTRIES INC SOLCHEM ITALIANA S P A FIDIA FARMACEUTICI SPA LABORATORIO BP SRL ARES SERONO SA SUBJECT INJECTION BLOW MOLDING FACILITY IN ROCHESTER, NEW YORK 3,4-DIAMINOPYRIDINE MFG. IN PLAINSBORO, NEW JERSEY PACKAGING MATERIALS AS MFG IN WOODBRIDGE ONTARIO CANADA

4Q2012

ARTIFICIAL CONCORD GRAPE FLAVOR 69-974 LIQUID MFG. IN CINCINNATI, OHIO PILOCARPINE HYDROCHLORIDE USP ORAL GRADE MANUFACTURED IN PARNAIBA, BRAZIL MANUFACTURING FACILITY IN ELMWOOD, WISCONSIN RIFAMPIN AS MFG. IN MULAZZANO (MI), ITALY LOPERAMIDE HYDROCHLORIDE AS MFG. IN MULAZZANO, (MI), ITALY CIMETIDINE AS MFG. IN SIDERNO, ITALY SODIUM CHLORIDE FOR INJECTION AS MFG. IN HAMELN, FEDERAL REPUBLIC OF GERMANY AND AUBONNE, SWITZERLAND MANUFACTURING FACILITIES IN GREENVILLE, SOUTH CAROLINA CELANEX PRODUCTS AS MANUFACTURED IN KELSTERBACH AND NIEDERZISSEN, GERMANY, FLORENCE, KENTUCKY, AND SHELBY, NORTH CAROLINA DESICCANT CARTRIDGES FINAL ASSEMBLY IN BUFFALO, NEW YORK TERAZOSIN HYDROCHLORIDE MANUFACTURED IN LAHR, GERMANY SELEGILINE (DEPRENYL) HYDROCHLORIDE AS MFG. IN SOMERVILLE, NEW JERSEY KETOCONAZOLE DRUG SUBSTANCE AS MANUFACTURED IN GURABO, PUERTO RICO INTERMEDIATES OF KETOCONAZOLE AS MFG. IN GEEL, BELGIUM MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF OXALIPLAIN IN KANAGAWA, JAPAN. OXALIPLATIN AS MFG. IN KANAGAWA, JAPAN DEFEROXAMINE MESYLATE AS MFG. IN KALAMAZOO, MICHIGAN UBINIMEX AS MFG. IN TOKYO, JAPAN PACKAGING MATERIAL NCPE 7003 AND NCPE 7007 AS MFG. IN STENUNGSUND, SWEDEN

CELANEX POLYBUTYLENE TEREPHTHALATE AS MANUFACTURED IN KELSTERBACH AND NIEDERZISSEN, GERMANY, FLORENCE, KENTUCKY, AND SHELBY, NORTH CAROLINA

COTTON AND RAYLON COILER MANUFACTURED IN VALLEY PARK, MISSOURI AND SPARKS, NEVADA GETTIG PHARMACEUTICAL INSTRUMENT CO GETTIG BLUNT ASSEMBLY AS MFG. IN SPRING MILLS, PENNSYLVANIA DIV GETTIG TECHNOLOGIES INC DIOSYNTH B V HEPARIN SODIUM AS MFG. IN OSS, THE NETHERLANDS ROLLPRINT PACKAGING PRODUCTS INC RPP #26-1010B AS MFG. IN ADDISON, ILLINOIS

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4Q2012EXCEL DMF# 10054 I 10055 10056 10057 10058 A 10059 10060 10061 10062 10063 10064 10065 I 10066 10067 I 10068 10069 10070 I 10071 10072 10073 10074 10075 10076 A 10077 A 10078 I 10079 10080 10081 10082 10083 10084 10085 I 10086 I I 2/10/1993 MEGA BLOW MOULDING LTD I I A A I I I II III III IV II I 2/15/1993 2/15/1993 1/26/1993 2/8/1993 2/10/1993 11/30/1992 2/5/1993 CASCADE BIOCHEM LTD CASCADE BIOCHEM LTD SHIOTANI GLASS CO LTD DAIKYO SEIKO LTD UNGERER AND CO KYOWA HAKKO KOGYO CO LTD DHP LTD I 8/27/1991 ACS DOBFAR SPA V 8/27/1991 ACS DOBFAR SPA A A I I I IV IV III III II V 2/3/1993 2/3/1993 12/11/1992 12/12/1992 2/5/1993 12/18/1986 A I II II I 2/4/1993 2/1/1993 2/2/1993 BACHEM AMERICAS INC COSMA SPA ZENECA PHARMACEUTICALS DIV ZENECA INC LUBRIZOL ADVANCED MATERIALS INC LUBRIZOL ADVANCED MATERIALS INC BOREALIS AG STATOIL PHARMACHEM CORP ACS DOBFAR SPA AC-137 AS MFG. IN TORRANCE, CALIFORNIA PANTETHINE AS MFG. IN CISERANO (BERGAMO), ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CAROLINA, PUERTO RICO. CARBOPOL 981 NF AS MFG. IN CALVERT CITY, KENTUCKY CARBOPOL 980 NF AS MFG. IN CALVERT CITY, KENTUCKY BOREALIS POLYPROPYLENE HC115MO AS MFG. IN STATHELLE, NORWAY STATOIL POLYETHYLENE LDPE, L610 AS MFG. IN STAHELLE, NORWAY IRON DEXTRAN AS MFG. IN BETHLEHEM, PENNSYLVANIA I II II 2/1/1993 1/31/1993 ZENECA INC I I I I I N I 1/27/1993 III II II II II 1/25/1993 1/26/1993 1/26/1993 1/26/1993 1/26/1993 OLACK AG MALG TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD TANABE SEIYAKU CO LTD NOT AN ASSIGNED NUMBER MERCIAN CORP SEALING LACQUER LO 7505 GRAU AS MFG. IN KALTBRUNN, SWITZERLAND BOTULINAL ANTITOXIN AS MFG. IN ST. PAUL, MINNESOTA L-THREONINE AS MFG. IN OSAKA, JAPAN L-LYSINE AS MFG. IN OSAKA, JAPAN L-PROLINE AS MFG. IN OSAKA, JAPAN I I I I I II II 1/25/1993 1/25/1993 1/25/1993 1/29/1993 STATUS Type SUBMIT DATE II 1/21/1993 HOLDER PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA GLAXO WELLCOME INC ASAHI GLASS CO LTD ASAHI GLASS CO LTD COPPERHEAD INVESTMENTS INC SUBJECT TERAZOSIN HYDROCHLORIDE AS MFG. IN VARESE, ITALY MANUFACTURING PRODUCTION FACILITY IN TORONTO, CANADA MANUFACTURING FACILITIES IN HIRAKAA CITY, OSAKA, JAPAN RO 09-1168 AS MFG. IN HIRAKAA CITY, OSAKA, JAPAN

4Q2012

SDM-71 NITROGLYCERIN TRANSDERMAL PATCH AS MFG. IN TAMAQUA, PENNSYLVANIA

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KUMAMOTO, JAPAN. SDM-70 NITROGLYCERIN/POLYMER MIXTURE AS MFG. IN TAMAQUA, PENNSYLVANIA

PROCTER AND GAMBLE PHARMACEUTICALS DIGOXIN DRUG SUBSTANCE AS MFG. IN LONGJUMEAU, FRANCE INC SUB PROCTER AND GAMBLE CO

STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS AT THE VIALE ADDETTA PLANT IN MILANO, ITALY STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS AT THE VIALE ROSSINI PLANT IN MILANO, ITALY FACILITY AND OPERATING PROCEDURES IN VIA MARZABOTTO, VIMERCATE, MILANO, ITALY (PREVIOUSLY AN ANTIBIOTIC FILE) MANUFACTURING FACILITY IN READING, BERKSHIRE, ENGLAND LEUKOTRIENE D4 IN ETHANOL MANUFACTURED IN READING, BERKSHIRE, ENGLAND AMPULES, VIALS AND CARTRIDGES MANUFACTURED IN TOYAMA, JAPAN PACKAGING MATERIALS MANUFACTURED IN TOCHIGI PREFECTURE, JAPAN ARTIFICIAL FRUIT FLAVOR #25288 MANUFACTURED IN BETHLEHEM, PENNSYLVANIA URACIL AS MFG. IN OSAKA, JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN POWYS, THE UNITED KINGDOM MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MISSISSAUGA, ONTARIO, CANADA Page

283

4Q2012EXCEL DMF# 10087 I 10088 10089 10090 I 10091 10092 10093 10094 10095 10096 10097 10098 I 10099 A 10100 I 10101 10102 10103 A 10104 10105 10106 10107 I 10108 10109 10110 A 10111 10112 I 10113 I 10114 I 10115 I 10116 10117 I I II I 3/3/1993 2/17/1993 FUJISAWA PHARMACEUTICAL CO LTD EUROPLAZ LIMITED II 3/3/1993 PHARMACO LSR II 3/1/1993 KURARAY CO LTD III 2/22/1993 I III II 2/22/1993 4/30/1980 SCHUBERT SEALS A/S LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO AMPACET CORP I A IV II II 2/16/1993 2/23/1993 2/26/1993 MILES INC IPCA LABORATORIES LTD COPPERHEAD INVESTMENTS INC A I I II II II II 2/19/1993 2/22/1993 2/26/1993 2/26/1993 SIFAVITOR SRL SEPPIC DIV AIR LIQUIDE ORIL WATSON LABORATORIES INC NICARDIPINE HYDROCHLORIDE AS MANUFACTURED IN MILANO, ITALY MONTANOX 80DF AS MANUFACTURED IN CASTRES, FRANCE I A II II II 2/25/1993 2/26/1993 2/22/1993 GENZYME CORP DAIICHI SANKYO PROPHARMA CO LTD SAFC INC II 2/22/1993 WHATMAN PAPER LTD IV 2/1/1993 SOLVAY FLUOR GMBH I I I I A I I IV III III III III V II III 2/11/1993 2/18/1993 2/18/1993 2/18/1993 2/12/1993 2/9/1993 2/11/1993 2/4/1993 QP CORP SABIC PETROCHEMICALS BV SABIC PETROCHEMICALS BV SABIC PETROCHEMICALS BV NIPRO GLASS AMERICAS CORP NATIONAL INSTITUTES OF HEALTH EGIS PHARMACEUTICALS H AND N CHEMICAL CO A A II II II 2/10/1993 1/29/1993 2/10/1993 INDENA SPA AJINOMOTO USA INC SIGMA F AND D DIV LTD STATUS Type SUBMIT DATE II 4/11/1991 HOLDER PHARMACIA AND UPJOHN INC SUBJECT

4Q2012

ERYTHROMYCIN ENTERIC-COATED TABLETS MANUFACTURED IN KALAMAZOO, MICHIGAN-PREVIOUSLY AN ANTIBIOTIC FILE COLCHICINE USP (ESUB) AS MANUFACTURED IN MILAN, ITALY M-HES AS MFG. IN KAWASAKI, KANAGAWA, JAPAN. HEPES, SODIUM SALT (N-2-HYDROXYETHYLPIPERAZINE-N'-2-ETHANESULFONIC ACID) AS MFG. IN SAINT LOUIS, MISSOURI SODIUM HYALURONATE AS MFG. IN TOKYO, JAPAN. SABIC LDPE 2100TN00 AS MFG. IN BEEK, THE NETHERLANDS. SABIC LDPE 2200TC00 AS MFG. IN BEEK, THE NETHERLANDS. SABIC LDPE 2200TC12 AS MFG. IN BEEK, THE NETHERLANDS. TUBING GLASS CONTAINERS MANUFACTURED IN MILLVILLE, NEW JERSEY. ANTI-FUNGAL DRUGS DOBUTAMINE HYDROCHLORIDE AS MFG. IN BUDAPEST, HUNGARY. PRESSURE SENSITIVE ADHESIVE CODED POLYTAC 212X26 AS MANUFACTURED IN TOTOWA, NEW JERSEY 1,1,1,2,3,3,3-HEPTAFLUOROPROPANE (R-227) PROPELLANT GAS AS MFG. IN FRANKFURT, FEDERAL REPUBLIC OF GERMANY DE52/D774 ANION EXCHANGE CELLULOSE AS MANUFACTURED AND TESTED IN MAIDSTONE, KENT, ENGLAND CERAMIDETRIHEXOSIDASE AS MFG. IN FRAMINGHAM, MASSACHUSSETTS LEVOFLOXACIN DRUG SUBSTANCE MANUFACTURED IN AKITA, JAPAN. MECHLORETHAMINE HYDROCHLORIDE AS MANUFACTURED IN MILWAUKEE, WISCONSIN

DEXFENFLURAMINE HYDROCHLORIDE AS MANUFACTURED IN BOLBEC, FRANCE PROGESTERONE VAGINAL SUPPOSITORY 100 MG. AND 200 MG. MANUFACTURED IN STATE COLLEGE, PENNSYLVANIA LEWATIT S 5428 A AS MANUFACTURED IN LEVERKUSEN, GERMANY BY BAYER AG FUROSEMIDE AS MANUFACTURED IN PIN, INDIA SDM-74 (20/80 NITROGLYCERIN-SOLVATED ADHESIVE POLYMER) MANUFACTURED IN TAMAQUA, PA RUBBER COMPOUND NO. 6457 MANUFACTURED IN HORSENS, DENMARK PIPERACILLIN MONOHYDRATE MANUFACTURED IN STAMFORD, CONNECTICUT (PREVIOUSLY AN ANTIBIOTIC FILE) 100267 AS MB MANUFACTURED IN BELGIUM, TERRE HAUTE, INDIANA AND DE RIDDER, LOUISIANA 1S,3S,4R-3-(2-PROPENYL)-BICYCLO[2,2,1] HEPTAN-2-ONE MANUFACTURED IN NIIGATA, JAPAN. METHOD VALIDATION REPORT, METHOD 29, GC/MS ANALYSIS OF UNCONJUGATED ESTRONE AND 17B-ESTRADIOL IN HUMAN PLASMA ZOTEPINE DRUG SUBSTANCE MANUFACTURED IN OSAKA AND FUJI, JAPAN MANUFACTURING FACILITIES, OPERATING PROCEDURES AND PERSONNEL LOCATED AT ESSEX, ENGLAND.

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4Q2012EXCEL DMF# 10118 A 10119 10120 I 10121 10122 I 10123 A 10124 10125 10126 I 10127 10128 A 10129 I 10130 I 10131 10132 I 10133 I 10134 10135 10136 10137 10138 10139 10140 I 10141 10142 10143 10144 I 10145 10146 I A II III 3/19/1993 3/5/1993 CANLAC GROUP ABBOTT PRODUCTS INC BASF AKTIENGESELLSCHAFT I I I III III II I 3/1/1993 3/2/1993 3/19/1993 3/19/1993 MITSUI PETROCHEMICAL AMERICA LTD MITSUI PETROCHEMICAL AMERICA LTD WITCO CORP CANLAC CORP I I A A A I I III III II IV II II 3/12/1993 2/25/1993 2/25/1993 3/5/1993 3/5/1993 6/10/1968 3/16/1993 MIDDLESEX SCIENCES INC BASF AKTIENGESELLSCHAFT BASF SE JOHNSON MATTHEY INC MANTROSE HAEUSER CO INC BRISTOL-MYERS SQUIBB COMPANY ENZYME DEVELOPMENT CORP II 2/2/1982 BRISTOL-MYERS SQUIBB COMPANY A II II 4/7/1989 6/20/1989 CORDEN PHARMA LATINA SPA BRISTOL-MYERS SQUIBB COMPANY II 7/31/1986 BIOCHIMICA OPOS 2 SPA II 11/18/1988 BIOCHIMICA OPOS 2 SPA N II 3/15/1993 NOT AN ASSIGNED NUMBER MALLINCKRODT INC I N II 6/26/1987 II 3/2/1993 OMNICHEM S A NOT AN ASSIGNED NUMBER BRISTOL MYERS SQUIBB COMPANY ACYCLOVIR AS MFG IN WETTEREN, BELGIUM. II 3/9/1993 MALLINCKRODT INC I II I 3/5/1993 3/5/1993 GUERBET CHIMIE AULNAY MARION MERRELL DOW S/A A II II 2/19/1993 12/4/1989 FINE CHEMICALS CORP PTY LTD BIOCHIMICA OPOS 2 SPA STATUS Type SUBMIT DATE III 3/8/1993 HOLDER AMCOR FLEXIBLES ITALIA SRL SUBJECT

4Q2012

PAPER / ALUMINUM / POLYETHYLENE LAMINATE DRUG WRAPPER PRODUCT WITH GLUE AND ADHESIVE MANUFACTURED IN VICENZA, ITALY. AZATHIOPRINE MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA. ACT, BULK, NON-STERILE MANUFACTURED IN AGRATE BRIANZA, MILAN, ITALY. (PREVIOUSLY AN ANTIBIOTIC FILE) SYNTHESIS OF P607 IN AULNAY SOUS BOIS, FRANCE. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BOURGOIN-JALLIEU CEDEX, FRANCE. ZICONOTIDE, MALLINCKRODT INC. CODE 8068 (ESUB) AS MANUFACTURED IN ST. LOUIS, MISSOURI.

CRUDE AMPHOTERICIN SLURRY MANUFACTURED IN ANAGNI, FROSINONE, ITALY (PREVIOUSLY AN ANTIBIOTIC FILE) FENTANYL CITRATE (NEW PROCESS) (ESUB) MANUFACTURED IN SAINT LOUIS, MISSOURI CEFAZOLIN FREE ACID AS MFG. IN AGRATE BRIANZA, MILAN, ITALY. (PREVIOUSLY AN ANTIBIOTIC FILE) CEFAZOLIN SODIUM, BULK AS MFG. IN AGRATE BRIANZA, MILAN, ITALY. (PREVIOUSLY AN ANTIBIOTIC FILE) L-ARGININE (ESUB) AS MANUFACTURED IN BARCELONETA, PUERTO RICO. 7-AMINO CEPHALOSPORANIC ACID (7-ACA) AS MFG. IN SYRACUSE, NEW YORK. (PREVIOUSLY AN ANTIBIOTIC FILE) PIPERACILLIN MONOHYDRATE AS MFG. IN SYRACUSE, NEW YORK. (PREVIOUSLY AN ANTIBIOTIC FILE) FACILITY AND PROCEDURES IN MANSFIELD, MASSACHUSETTS. ULTRAFORM H 2320 AS MFG. IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY. ULTRAFORM S 2320 AS MFG. IN LUDWIGSHAFEN, GERMANY. METHYLPHENIDATE HYDROCHLORIDE AS MFG. IN WEST DEPTFORD, NEW JERSEY. CRYSTALAC GLAZE FORMULA C MFG. ATTLEBORO, MASSACHUSETTS 6-APA MANUFACTURED IN SYRACUSE, NEW YORK. (PREVIOUSLY AN ANTIBIOTIC FILE) ENZECO PURIFIED PROTEOLYTIC ENZYME POWDER MFG. IN SCRANTON, PENNSYLVANIA ADMER Q F 500 A MFG. IN LAPROTE, TEXAS ADMER A689A, A820A, NB550A AND NF530A MFG. IN LAPROTE, TEXAS WITCONATE NONOXYNOL 9 MANUFACTURED IN HARAHAN, LOUISIANA MANUFACTURING FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN VICTORIAVILLE, PQ, CANADA LACTULOSE CONCENTRATE AS MANUFACTURED IN VICTORIAVILLE, PQ, CANADA LUPOLEN KNOZ. SL 02 OA MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY

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4Q2012EXCEL DMF# 10147 I 10148 10149 I 10150 10151 I 10152 I 10153 I 10154 A 10155 I 10156 10157 I 10158 10159 10160 10161 10162 10163 A 10164 A 10165 10166 I 10167 A 10168 10169 10170 I 10171 10172 I 10173 I 10174 I II 3/31/1993 LIFE TECHNOLOGIES INC I 3/8/1993 YUKI GOSEI KOGYO CO LTD I III II 3/24/1993 12/14/1987 A I III II I 2/11/1993 3/26/1993 3/31/1993 SUMIKEI ALUMINUM FOIL CO LTD TANABE SEIYAKU CO LTD PHARMACEUTICAL FACTORY SHANGHAI INSTITUTE PHARMACEUTICAL INDUSTRY COLORS FOR PLASTICS JOHNS HOPKINS UNIV II 3/31/1993 BAYER SCHERING PHARMA AG A II III 3/26/1993 3/30/1993 APTALIS PHARMATECH INC BAYER AG III 3/25/1993 COIM USA INC I I I I I I II III II II III 3/26/1993 3/24/1993 3/23/1993 3/23/1993 3/24/1993 3/25/1993 INTERNATIONAL TOLLERS INC NORAMCO DELAWARE INC RAGE CORP PERKIN ELMER LIFE SCIENCES NORAMCO DELAWARE INC COIM USA INC I II IV 10/8/1991 3/24/1993 ASTELLAS PHARMA INC UNGERER AND CO II 8/27/1974 BRISTOL MYERS SQUIBB COMPANY II 3/1/1991 ACS DOBFAR SPA II 5/8/1991 ASTELLAS PHARMA INC V 8/7/1972 ASTELLAS PHARMA INC I III II 3/24/1993 3/30/1993 SOLVAY AND CIE SA RIEDEL DE HAEN I III III 2/17/1993 3/24/1993 BASELL POLIOLEFINE ITALIA SPA SOLVAY AND CIE SA STATUS Type SUBMIT DATE III 2/17/1993 HOLDER BASF AKTIENGESELLSCHAFT SUBJECT

4Q2012

LUPOLEN 1810 S WHITE 99950 MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY LUPOLEN 1800 S MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY HD POLYETHYLENE ELTEX A 4019 MANUFACTURED IN SARRALBE, FRANCE AND ROSIGNANO-SOLVAY LI, ITALY POLYPROPYLENE ELTEX P RP 210 MANUFACTURING IN SARRALBE, FRANCE 2-(2-METHOXYPHENOXY)-ETHYL TOLUENE-4-SULFONATE MANUFACTURED IN SEELZE, GERMANY. STERILE PROCESSING FACILITIES FOR CEFAZOLIN SODIUM STERILE, (BULK) ASLOCATED IN FUJI, JAPAN OXY-COMPOUND AN INTERMEDIATE TO PURIFIED CEFTIZOXIME AS MANUFACTURED IN TAKAOKA, JAPAN. (PREVIOUSLY AN ANTIBIOTIC FILE) ACID CEFUROXIME AS MFG. IN VIALE ADDETTA, TRIBIANO, MILAN ITALY. (PREVIOUSLY AN ANTIBIOTIC FILE) 7-ADCA MANUFACTURED BY SQUIBB S.P.A. IN ANAGNI, ITALY (PREVIOUSLY AN ANTIBIOTIC FILE) CEFAZOLIN AS MANUFACTURED AT THE FUJI PLANT, JAPAN. FLAVOLOPE NATURAL BANANA TYPE FLAVOR #21724 MANUFACTURED IN LINCOLN PARK, NEW JERSEY. FACILITY LOCATED IN GRAND HAVEN, MICHIGAN. CODEINE SULFATE MANUFACTURED IN WILMINGTON, DELAWARE. PACKAGING MATERIALS (PLASTIC BOTTLES) MANUFACTURED IN HILLIARD OHIO. [14C]-UREA MANUFACTURED IN BOSTON, MASSACHUSETTS CODEINE MANUFACTURED IN WILMINGTON, DELAWARE. NOVACOTE ADH22, CROSS LINKED WITH NOVACOTE CR 12 MANUFACTURED BY C.E.L. IN NEW CASTLE, DELAWARE AND IN HAMBURG, GERMANY. NOVACOTE ADH250, CROSS LINKED WITH NOVACOTE CR 30 OR CR 32 MANUFACTURED NY C.E.L. IN NEW CASTLE, DELAWARE AND IN HAMBURG, GERMANY IBUPROFEN GELATIN/CAP MICROCAPSULES, AS MANUFACTURED IN VANDALIA, OH. MAKROLON 2458 90/110 MANUFACTURED IN KREFELD-VERDINGEN, FEDERAL REPUBLIC OF GERMANY. NISOLDIPINE (ESUB) AS MANUFACTURED IN WUPPERTAL, FEDERAL REPUBLIC OF GERMANY. PTP FOIL P-125 MANUFACTURED IN THE ISESAKI PLANT, JAPAN HER.TIAZEPN MANUFACTURED AT THE ONADA PLANT, JAPAN FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN THE PUDONG NEW DISTRICT, SHANGHAI, P.R. CHINA COLORANT, ACPP 10001 MANUFACTURED IN HUNTLEY, ILLINOIS POLY I: POLY C12U MANUFACTURED IN BALTIMORE, MARYLAND (PREVIOUSLY BIOLOGICS FILE #2789) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF NIACINAMIDE IN JOBAN, IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN. KERAINOCYTE-SFM (SERUM FREE KERAINOCYTE MEDIUM) PRODUCED IN GRAND ISLAND, NEW YORK.

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4Q2012EXCEL DMF# 10175 10176 I 10177 10178 10179 I 10180 I 10181 I 10182 10183 I 10184 10185 10186 I 10187 I 10188 I 10189 I 10190 I 10191 I 10192 10193 10194 10195 10196 I 10197 I 10198 I 10199 A 10200 I 10201 A III 4/19/1993 3M DRUG DELIVERY SYSTEMS III 4/19/1993 3M PHARMACEUTICALS III 4/19/1993 3M PHARMACEUTICALS III 1/27/1993 CROWN CORK AND SEAL CO INC I 4/17/1993 ABBOTT LABORATORIES I I I I III III III II IV 4/7/1993 4/7/1993 4/7/1993 4/13/1993 4/10/1993 II 4/13/1993 SHANGHAI INSTITUTE PHARMACEUTICAL INDUSTRY SUN COAST CLOSURES INC SUN COAST CLOSURES INC SUN COAST CLOSURES INC ACS DOBFAR SPA MARUTI LABORATORIES PRIVATE LTD II 4/8/1993 TAKASAGO INTERNATIONAL CORP I 4/8/1993 TAKASAGO INTERNATIONAL CORP II 4/8/1993 I 4/12/1993 JOHNSON AND JOHNSON/MERCK AND COMPANY INC SIGMA F AND D DIV LTD I C III II I 3/22/1993 4/12/1993 3/23/1993 H AND N CHEMICAL CO NV ORGANON ABBOTT LABORATORIES LTD I II I 4/7/1993 11/4/1992 XIAN PHARMACEUTICAL FACTORY LABORATOIRES STERILYO I 4/6/1993 BESPAK PLC II 12/6/1983 ACS DOBFAR UK LTD N N II 6/8/1989 STATUS Type SUBMIT DATE A II II 3/30/1993 5/6/1974 HOLDER NV ORGANON DSM SINOCHEM PHARMACEUTICALS NETHERLANDS BV NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER GLAXOCHEM LIMITED SUBJECT

4Q2012

DESMOPRESSIN (NEW PROCESS) MANUFACTURED IN OSS, THE NETHERLANDS. 7-ADCA MANUFACTURED IN DELFT, THE NETHERLANDS\

PENICILLIN G INTERMEDIATES MANUFACTURED IN THE ULVERSON PLANT, ENGLAND (PREVIOUSLY AN ANTIBIOTIC FILE) PENICILLIN G INTERMEDIATES MANUFACTURED IN CAMBOIS, ENGLAND (PREVIOUSLY AN ANTIBIOTIC FILE) MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NORFOLK, ENGLAND. PODOFILOX MANUFACTURED IN XIJIAO, XI'AN, SHAANXI PROVINCE, CHINA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SAINT-AMAND-LES-EAUX CEDEX, FRANCE. POLYTAC 221R MANUFACTURED IN TOTOWA, NEW JERSEY NORETHINDRONE ACETATE PROCESS II MANUFACTURED IN OSS, THE NETHERLANDS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ETHRANE IN QUEENBOUROUGH, KENT, ENGLAND. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LANCASTER, PENNSYLVANIA. SOMATOSTATIN (PRODUCT NO. S 9129 FD) MANUFACTURED IN SAINT LOUIS, MISSOURI MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN IWAA, JAPAN. 4-AA, OR [3R-[3A(R*),4B]]-4-(ACETYLOXY)-3-[[91,1-DIMETHYLETHYL)DIMETHYLSILYL]OXY]ETHYL]-2-AZETIDINONE MANUFACTURED A THE ITAWA PLANT AND THE HARIMA PLANT IN JAPAN ETOPOSIDE MANUFACTURED IN PUDONG NEW DISTRICT, SHANGHAI 120MM LINED CAP MANUFACTURED IN SARASOTA, FLORIDA 53-400 LINERLESS CLOSURE MANUFACTURED IN SARASOTA, FLORIDA 89-400 M/D LINED CAP MANUFACTURED IN SARASOTA, FLORIDA PHOSPHATE SODIUM DIBASIC STERILE MANUFACTURED IN TRIBIANO, MILAN, ITALY MICROCRYSTALLINE CELLULOSE (MCC) PH 101/102 MANUFACTURED IN CUDDALORE, TAMILNADU, INDIA FACILITIES AND OPERATING PROCEDURES IN LATINA, ITALY (LABORATORI ABBOTT S.P.A.) PILFER PROOF CAPS MANUFACTURED BY CROWN BENDER IN FRANKENTHAL, W. GERMANY 3M SCOTCHPAK 9723 POLYESTER FILM LAMINATE MANUFACTURED IN COTTAGE GROVE, MINNESOTA 3M SCOTCHPAK 9721 POLYESTER FILM LAMINATE MANUFACTURED IN COTTAGE GROVE, MINNESOTA 3M COTRAN 9722 POLYOLEFIN FILM LAMINATE MANUFACTURED IN COTTAGE GROVE, MINNESOTA

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4Q2012EXCEL DMF# 10202 I 10203 I 10204 A 10205 10206 10207 10208 10209 10210 10211 I 10212 10213 10214 I 10215 I 10216 I 10217 I 10218 10219 10220 10221 10222 I 10223 10224 10225 10226 10227 10228 A 10229 10230 A 10231 10232 10233 I I A II II II 5/7/1993 3/6/1993 5/5/1993 JOHNSON MATTHEY INC LABOCHIM SPA CILAG AG I IV III 4/22/1993 4/26/1993 AQUALON CO BECTON DICKINSON AND CO I I I I I II II II II II III 5/5/1993 5/5/1993 4/30/1993 4/23/1993 4/23/1993 5/5/1993 PRODUCTOS QUIMICOS NATURALES S A JOHNSON MATTHEY INC TAKEDA CHEMICAL INDUSTRIES LTD ALDRICH CHEMICAL CO INC ALDRICH CHEMICAL CO INC 3M DRUG DELIVERY SYSTEMS A I A A II II II IV III 5/4/1993 4/30/1993 5/4/1993 5/3/1993 5/7/1993 II 4/27/1993 IV 4/27/1993 II 4/8/1993 A I IV II I 4/26/1993 4/22/1993 4/8/1993 CRODA INC JOHNSON MATTHEY INC LANCASTER SYNTHESIS DIV MTM RESEARCH CHEMICALS LTD LANCASTER SYNTHESIS DIV MTM RESEARCH CHEMICALS LTD UNION CARBIDE CHEMICALS AND PLASTICS CO INC DSM PHARMA CHEMICALS SOUTH HAVEN INC BAYER OY THATCHER CO NV ORGANON MANTROSE HAEUSER CO INC HELVOET PHARMA MARYLAND I N I I I I III III III III II 4/19/1993 4/19/1993 4/19/1993 4/19/1993 4/22/1993 III 4/15/1993 MAUSER WERKE GMBH NOT AN ASSIGNED NUMBER COLORS FOR PLASTICS COLORS FOR PLASTICS COLORS FOR PLASTICS ACTION COLOR INC WHATMAN PAPER LTD ACPP-60167 MANUFACTURED IN HUNTLEY, ILLINOIS ACPP-60166 MANUFACTURED IN HUNTLEY, ILLINOIS ACPP-30070 MANUFACTURED IN HUNTLEY, ILLINOIS ACPP-60207 MANUFACTURED IN HUNTLEY, ILLINOIS III 4/5/1993 ABLE PACKAGING LTD I 4/21/1993 INTERNATIONAL LABORATORIES INC STATUS Type SUBMIT DATE II 4/22/1993 HOLDER PENINSULA LABORATORIES SUBJECT

4Q2012

CHOLECYSTOKININ TETRAPEPTIDE (30-33) (CCK-4, PL #7185) MANUFACTURED IN BELMONT, CALIFORNIA MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN ST. PETERSBURG, FLORIDA. PACKAGING MATERIALS ANTI-STATIC MANUFACTURED IN BYLEY, CHESHIRE, ENGLAND PACKAGING MATERIAL MANUFACTURED IN BAMMENTAL AND BRUHL, GERMANY

DEAE-CELLULOSE/D617 ANION EXCHANGE CELLULOSE MANUFACTURED IN MAIDSTONE, KENT, ENGLAND SUPER REFINED SOYBEAN OIL MANUFACTURED IN PARSIPPANY, NEW JERSEY PROCHLORPERAZINE EDISYLATE MANUFACTURED IN WEST DEPTFORD, NEW JERSEY FACILITIES AND PROCEDURES IN LANCASTER, ENGLAND METHYLENE DIPHOSPHONIC ACID MANUFACTURED IN LANCASTER, ENGLAND TONE P-767E AND TONE P-787 MANUFACTURED IN SOUTH CHARLESTON, WEST VIRGINIA 3M ORPHENADRINE CITRATE MANUFACTURED IN SOUTH HAVEN, MICHIGAN NORPLANT (LEVONORGESTREL IMPLANTS) MANUFACTURED IN TURKU, FINLAND IODOPHOR 241 FORMULA 47D MANUFACTURED IN SALT LAKE CITY, UTAH GONADORELIN DIACETATE MANUFACTURED IN OSS, THE NETHERLANDS AQUEOUS GLAZE SB-1/P MANUFACTURED IN ATTLEBORO, MASSACHUSETTS RUBBER CLOSURE FORMULATION B5301-45 GRAY MANUFACTURED IN SALISBURY, MARYLAND FLUORANDROSTENONE MANUFACTURED IN IXTACZOQUITLAN, VER. MEXICO AUROTHIOGLUCOSE MANUFACTURED IN WEST DEPTFORD, NEW JERSEY TAK-536 DRUG SUBSTANCE MANUFACTURED IN OSAKA, JAPAN ISOBUTYRAMIDE MANUFACTURED IN MILWAUKEE, WISCONSIN BUTYRIC ACID MANUFACTURED IN MILWAUKEE, WISCONSIN 3M SCOTCHPAK 9742 RELEASE LINER MANUFACTURED IN ST. PAUL, MN., COTTAGE GROVE, MN. AND NEVADA, MO. HYDROXYETHYL CELLULOSE MANUFACTURED IN WILMINGTON, DELAWARE MONOVIAL-INF. NG (DRUG CONTAINER AND CLOSURE) MANUFACTURED IN GLAND, SWITZERLAND GOLD SODIUM THIOMALATE MANUFACTURED IN WEST DEPTFORD, NEW JERSEY LEUCOVORIN CALCIUM MANUFACTURED IN MILAN, ITALY RIMANTADINE HYDROCHLORIDE MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND

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4Q2012EXCEL DMF# 10234 I 10235 10236 I 10237 I 10238 I 10239 10240 10241 10242 A 10243 A 10244 I 10245 A 10246 10247 10248 10249 10250 10251 10252 I 10253 A 10254 I 10255 A 10256 10257 10258 I 10259 A 10260 I 10261 10262 10263 I I I II II II 5/26/1993 5/25/1993 5/27/1993 BIOREX RESEARCH DEVELOPMENT CO JETPHARMA SA TAKEDA CHEMICAL INDUSTRIES LTD IV 5/17/1993 BENTLEY PHARMACEUTICALS INC CYCLOPENTADECANOLIDE MANUFACTURED BY FIRMENICH S.A. IN GENEVA, SWITZERLAND MOLINDONE HYDROCHLORIDE MANUFACTURED IN BUDAPEST, HUNGARY. CONTRACT MICRONIZATION SERVICES LOCATED IN BALERNA, SWITZERLAND TAP-144-SR(N) 7.5 AND 3.75 MG. MANUFACTURED IN OSAKA, JAPAN. III 5/21/1993 I I II I III 5/24/1993 5/20/1993 5/3/1993 KAKEN PHARMACEUTICAL CO LTD OTSUKA PHARMACEUTICAL CO LTD V 5/18/1993 ISOTRON WESTPORT LIMITED II 5/12/1993 NEULAND LABORATORIES LTD II 5/12/1993 NEULAND LABORATORIES LTD I I I I I I III II II III II II III 5/12/1993 5/17/1993 5/17/1993 5/14/1993 5/18/1993 5/14/1993 5/21/1993 MITSUI PETROCHEMICAL AMERICA LTD DIOSYNTH BV WYCKOFF CHEMICAL CO INC OMV WERKSTOFF PCD POLYMERE GMBH SYNKEM DIV PLASTO SA ABBOTT LABORATORIES HELVOET PHARMA MARYLAND III 5/6/1993 HENKEL AG AND CO KGAA I 5/7/1993 WILLIAM RANSON AND SON LTD V 4/30/1993 I I I I I I II 4/22/1993 5/10/1993 5/7/1993 4/26/1993 PRIMA PHARM INC TATEYAMA KASEI CO LTD NV ORGANON BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG IONISOS FACILITY AND OPERATING PROCEDURES IN SAN DIEGO, CALIFORNIA TOYAMA PLANT IN TOYAMA PREF., JAPAN FACILITY AND PROCEDURES IN OSS, THE NETHERLANDS - MOLENSTRAA 110 DIHYDROERGOTAMINE MESYLATE MANUFACTURED IN INGELHEIM, GERMANY II 4/14/1993 BK LADENBURG GMBH II 4/14/1993 BK LADENBURG GMBH I II II 5/5/1993 4/14/1993 TEVA PHARMACEUTICAL INDUSTRIES LTD BK LADENBURG GMBH STATUS Type SUBMIT DATE II 5/4/1993 HOLDER NORTH CHINA PHARMACEUTICAL CORP SUBJECT

4Q2012

PENICILLIN G POTASSIUM CRUDE MANUFACTURED IN SHIJIAZHUANG, PEOPLE'S REPUBLIC OF CHINA SELEGILINE HYDROCHLORIDE MANUFACTURED IN PETAH TIQVA, ISRAEL PHOSKADENT SF (SODIUM FLUORIDE) MANUFACTURED IN HANNOVER-SEELZE, GERMANY PHOSKADENT TM (SODIUM TRIMETAPHOSPHATE) MANUFACTURED IN LADENBURG, GERMANY DENTPHOS C (CALCIUM HYDROXYLAPAITE) MANUFACTURED IN LADENBURG, GERMANY

FACILITY AND PROCEDURES FOR GAMMA RAY STERILIZATION IN SABLE SUR SARTHE, FRANCE FACILITY FOR THE MANUFACTURED OF LIQUID PHARMACEUTICALS IN HERTFORDSHIRE, ENGLAND LIOFOL, LAMINATING ADHESIVE,MANUFACTURED IN DUSSELDORF, FEDERAL REPUBLIC OF GERMANY ADMER QF551E MANUFACTURED IN LAPROTE, TEXAS PANCURONIUM BROMIDE MANUFACTURED IN OSS, THE NETHERLANDS FLURBIPROFEN SODIUM MANUFACTURED IN SOUTH HAVEN, MICHIGAN DAPLEN KS101 MANUFACTURED IN LINZ, AUSTRIA B.P. 102 MANUFACTURED IN CHENOVE CEDEX, FRANCE PROTIRELIN (TRH) MANUFACTURED IN NORTH CHICAGO, ILLINOIS RUBBER CLOSURE FORMULATION V 7000-55 BLACK MANUFACTURED IN SALISBURY, MARYLAND BENZYL ALBUTEROL,INTERMEDIATE MANUFACTURED IN BONTHAPALLI VILLIAGE, JINNARAM MANDAL, ANDHRA PRADESH, INDIA ALBUTEROL SULFATE MANUFACTURED IN BONTHAPALLI VILLIAGE, JINNARAM MANDAL, ANDHRA PRADESH, INDIA COBALT 60 GAMMA IRRADIATION CONTRACT STERILIZATION FACILITY LOCATED IN WESTPORT, CO. MAYO, IRELAND KP-102 MANUFACTURED IN SHIZOUKA PREFECTURE, JAPAN FORMULATION RESEARCH INSTITUTE IN TOKUSHIMA, JAPAN

GETTIG PHARMACEUTICAL INSTRUMENT CO GETTIG NEEDLE ASSEMBLY MANUFACTURED IN SPRING MILLS, PENNSYLVANIA, DIV GETTIG TECHNOLOGIES INC ANGOLA AND KNOX INDIANA OWENS BROCKWAY GLASS CONTAINER INC GLASS CONTAINERS (FLINT AND AMBER)

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4Q2012EXCEL DMF# 10264 10265 10266 I 10267 I 10268 A 10269 10270 10271 I 10272 10273 A 10274 10275 10276 I 10277 10278 10279 10280 10281 I 10282 I 10283 10284 I 10285 10286 10287 10288 10289 10290 A 10291 10292 I 10293 I 10294 A II 6/14/1993 NV ORGANON II 6/11/1993 LABORATOIRES SERONO SA A III V 6/9/1993 6/12/1993 N N I I I III III II II 6/7/1993 6/9/1993 6/14/1993 6/14/1993 NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER BASELL POLIOLEFINE ITALIA SPA TEKNI PLEX INC BIO RAD JOHNSON MATTHEY PHARMACEUTICAL MATERIALS MULTISORB TECHNOLOGIES INC FUJISAWA PHARMACEUTICAL CO LTD LUPOLEN 5261 ZS MANUFACTURED IN WESSELING, GERMANY. F93SR-1 MANUFACTURED IN EXTON, PENNSYLVANIA I II III 6/10/1993 6/11/1993 BACHEM FEINCHEMIKALIEN AG HELVOET PHARMA MARYLAND II 6/3/1993 JUZEN CHEMICAL CO LTD A I I I III II II II II 5/31/1993 6/3/1993 6/3/1993 6/7/1993 6/8/1993 FUJIMORI KOGYO CO LTD BIO RAD BIO RAD UNIQUE CHEMICALS NORTH CHINA PHARMACEUTICAL CORP A I II II III 6/4/1993 6/4/1993 5/28/1993 I I II 5/28/1993 5/27/1993 ABBOTT LABORATORIES LTD I I IV II III 6/2/1993 5/26/1993 5/25/1993 II 6/3/1993 II 6/3/1993 STATUS Type SUBMIT DATE I I II II II 5/24/1993 5/17/1993 6/3/1993 HOLDER LONZA INC ZAMBON GROUP SPA SUBJECT DEXTROMETHORPHAN BASE MANUFACTURED IN LOS ANGELES, CALIFORNIA WAY-125,147 CRUDE MANUFACTURED IN VICENZA, ITALY

4Q2012

SMITHKLINE BEECHAM PHARMACEUTICALS BRL 47539 (2-ACETOXYMETHYL-4-IODOBUT-1-YL-ACETATE) MANUFACTURED IN IRVINE, AYRSHIRE, UNITED KINGDOM. SMITHKLINE BEECHAM PHARMACEUTICALS BRL 47539 (2-ACETOXYMETHYL-4-IODOBUT-1-YL-ACETATE) MANUFACTURED IN WORTHING, WEST SUSSEX, UNITED KINGDOM. WELLSPRING PHARMACEUTICAL CORP DIBENZYLINE (SK&F 688-A) SOLUTION FOR INJECTION MANUFACTURED IN SWEDELAND, PENNSYLVANIA. PARKE DAVIS DIV WARNER LAMBERT CO CAPILL MANUFACTURED IN GREENWOOD, SOUTH CAROLINA LONZA LTD TEMPIL DIV BIG THREE INDUSTRIES INC DEBMEB MANUFACTURED IN VISP, SWITZERLAND SERIES 200 POLYMER ACTIVATED INKS MANUFACTURED IN SOUTH PLAINFIELD, NEW JERSEY SEMI-WORKS AREA IN QUEENBOROUGH, KENT, UNITED KINGDOM

UNION QUIMICO FARMACEUTICA SA UQUIFA RANITIDINE HYDROCHLORIDE (CRYSTALLINE FORM) MANUFACTURED IN BARCELONA, SA SPAIN CU CHEMIE UETIKON GMBH PHENYLACETIC ACID SODIUM SALT MANUFACTURED IN LAHR, GERMANY. PENINSULA LABORATORIES HELVOET PHARMA MARYLAND TJN-135 MANUFACTURED IN BELMONT, CALIFORNIA. RUBBER CLOSURE FORMULATION B5004-50 GRAY MANUFACTURED IN SALISBURY, MARYLAND. RELEASE LINER FILM MANUFACTURED IN, SHIZUOKA PREF., JAPAN. BIO-GEL A-5M, MEDIUM MANUFACTURED IN RICHMOND, CALIFORNIA. PC CROSSLINKED BIO-GEL A-5M, MEDIUM MANUFACTURED IN RICHMOND, CALIFORNIA. NIFEDIPINE MANUFACTURED IN BOMBAY, INDIA. CYCLOSPORINE, USP (BULK, NON-STERILE) MANUFACTURED IN SHIJIAZHUANG, CHINA. METHYL (2R,3S)-3-(4-METHOXYPHENYL)-2,3-EPOXYPROPIONATE MANUFACTURED IN TOYOMA CITY, JAPAN. DESMOPRESSIN ACETATE MANUFACTURED IN BUBENDORF, SWITZERLAND. RUBBER CLOSURE FORMULATION B5002-50 RED MANUFACTURED IN SALISBURY, MARYLAND.

AG 1-X2 RESIN, 200-400 MESH, ACETATE MANUFACTURED IN RICHMOND, CALIFORNIA CARMUSTINE MANUFACTURED IN WEST DEPTFORD, NEW JERSEY DESIMAX MANUFACTURED IN BUFFALO, NEW YORK STERILE PROCESSING FACILITIES FOR PROGRAF (TACOLIMUS) AMPOULES AS LOCATED IN BANSAGH, KILLOGLIN, CO. KERRY, IRELAND. BULK GRF (1-29) NH2 (SERMORELIN ACETATE DRUG SUBSTANCE) MANUFACTURED IN AUBONNE, SWITZERLAND. OXYTOCIN PURIFIED MANUFACTURED IN OSS, THE NETHERLANDS

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4Q2012EXCEL DMF# 10295 I 10296 10297 I 10298 10299 10300 I 10301 I 10302 10303 10304 A 10305 10306 10307 10308 10309 10310 A 10311 I 10312 10313 I 10314 I 10315 10316 10317 10318 A 10319 I 10320 A 10321 10322 10323 I 10324 I I 6/24/1993 CCL INDUSTRIES LTD I A II II II 6/25/1993 6/25/1993 6/17/1993 II 6/24/1993 MALLADI DRUGS AND PHARMACEUTICALS LTD DAINIPPON SUMITOMO PHARMA CO LTD DAINIPPON SUMITOMO PHARMA CO LTD NAGASE FINE CHEMICALS LTD II 6/24/1993 I I I II II II III 6/16/1993 6/25/1993 6/25/1993 6/29/1993 LUSOCHIMICA SPA SIPSY LONZA RIVERSIDE TOTAL PETROCHEMICALS AND REFINING USA INC CATALENT PHARMA SOLUTIONS LLC III 6/14/1993 BASF AKTIENGESELLSCHAFT I I III 6/25/1993 6/14/1993 LIPHA SA BASF AKTIENGESELLSCHAFT II 6/28/1993 BURZYNSKI RESEARCH INSTITUTE INC I N I I I III I II II 6/16/1993 6/29/1993 6/29/1993 6/30/1993 I 6/29/1993 I A I II V 6/18/1993 4/1/1987 6/24/1993 UNIQUE CHEMICALS ACS DOBFAR SPA BAXTER PHARMACEUTICALS SOLUTIONS LLC ONO PHARMACEUTICAL CO., LTD NOT AN ASSIGNED NUMBER ACTION COLOR INC CREAPHARM SA 3M BIOAPPLICATIONS SANOFI AVENTIS CHIMIE ACPP-80071 COLORANT MANUFACTURED IN HUNTLEY, ILLINOIS FACILITY AND OPERATING PROCEDURES IN LE HAILLAN, FRANCE II 6/11/1993 ARCHER DANIELS MIDLAND CO I I II II III 6/14/1993 6/15/1993 6/18/1993 I II II 6/14/1993 6/17/1993 STATUS Type SUBMIT DATE II 6/17/1993 HOLDER ZENECA PHARMACEUTICALS DIV ZENECA INC CHEMSYN SCIENCE LABORATORIES CHINOIN PHARMACEUTICAL CHEMICAL WORKS ROFERM SPA BRACCO IND CHIMICA SPA HELVOET PHARMA MARYLAND SUBJECT HALOTHANE MANUFACTURED AT ROCKSAVAGE WORKS, UNITED KINGDOM

4Q2012

DOBUTAMINE HYDROCHLORIDE MANUFACTURED IN HARRISONVILLE, MISSOURI GLIBENCLAMIDE BP88 (GLYBURIDE) MANUFACTURED IN BUDAPEST, HUNGARY 7-AMINOCEPHALOSPORANIC ACID MANUFACTURED IN TRENTO, ITALY IOMEPROL MANUFACTURED IN MILAN, ITALY RUBBER CLOSURE FORMULATION B5005-45 GRAY MANUFACTURED IN SALISBURY, MARYLAND POTASSIUM CITRATE MONOHYDRATE MANUFACTURED IN SOUTHPORT, NORTH CAROLINA FACILITY AND PROCEDURES IN ANKLESHWAR, INDIA ACID CEFAZOLIN (INTERMEDIATE GRADE) MANUFACTURED IN MILAN, ITALY STERILE PROCESSING FACILITY IN BLOOMINGTON, INDIANA. FACILITY AND OPERATING PROCEDURES IN OSAKA, JAPAN

3M EMPHAZE AB 1 SUPPORT MEDIUM MANUFACTURED IN ST. PAUL, MINNESOTA SR 47436 DRUG SUBSTANCE MANUFACTURED IN ARAMON, SISTERON AND MONTPELLIER CEDEX, FRANCE ANTINEOPLASTON A10 INJECTIONS MANUFACTURED IN STAFFORD AND HOUSTON, TEXAS FACILITY AND PROCEDURES IN SEMOY, FRANCE NOVOLEN 1125 N MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY NOVOLEN 1325 M MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY RITODRINE HYDROCHLORIDE MANUFACTURED IN LOMAGNA, ITALY PENTAMIDINE ISETHIONATE MANUFACTURED IN AVRILLE CEDEX, FRANCE TRANYLCYPROMINE SULFATE MANUFACTURED IN CONSHOHOCKEN, PENNSYLVANIA FINA GF7740F2 AND 8183 HIGH DENSITY POLYETHYLENE RESINS MANUFACTURED IN PASADENA, TEXAS HYTRIN (TERAZOSIN) SOFT GELATIN CAPSULES AS MANUFACTURED IN ST. PETERSBURG, FL D-PSEUDO EPHEDRINE HYDROCHLORIDE MANUFACTURED IN TAMILNADU, INDIA MEROPENEM/SODIUM CARBONATE MFG IN OSAKA, JAPAN MEROPENEM MFG IN TSURUSAKI, JAPAN. METHYL (2R,3S)-(4-METHOXYPHENYL)-2,3-EPOXYPROPIONATE MANUFACTURED IN TASUNO CITY, JAPAN FACILITY AND OPERATING PROCEDURES IN RUNCORN, UNITED KINGDOM

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4Q2012EXCEL DMF# 10325 I 10326 I 10327 I 10328 10329 10330 10331 I 10332 10333 A 10334 A 10335 10336 10337 10338 I 10339 10340 10341 I 10342 I 10343 I 10344 I 10345 I 10346 I 10347 10348 10349 10350 A 10351 10352 10353 A 10354 I III 7/6/1993 MARVAL A A III III II 7/9/1993 7/6/1993 7/13/1993 GERRESHEIMER LOHR GMBH CLARIANT MASTERBATCHES NORDEN AB BAYER SCHERING PHARMA AG GLASS CONTAINERS MANUFACTURED IN LOHR A. MAIN, GERMANY MASTERBATCH PE-10993 MANUFACTURED IN MALMO, SWEDEN I A I III III II II 5/22/1993 7/8/1993 7/12/1993 6/23/1993 PRESSPART MANUFACTURING LTD ALBEA AMERICAS INC BURZYNSKI RESEARCH INSTITUTE INC III 6/29/1993 BASF AKTIENGESELLSCHAFT III 6/29/1993 BASF AKTIENGESELLSCHAFT III 6/29/1993 BASF AKTIENGESELLSCHAFT III 6/29/1993 BASF AKTIENGESELLSCHAFT III 7/6/1993 AMPACET CORP I A I II III 7/12/1993 6/28/1993 7/6/1993 PHARMACIA AND UPJOHN COMPANY BASF PHARMACHEMIKALIEN GMBH CO KG AMPACET CORP A I I II II I I 6/29/1993 7/12/1993 7/12/1993 7/12/1993 ASAHI GLASS CO LTD HAFSLUND NYCOMED PHARMA AG PHARMACIA AND UPJOHN INC PHARMACIA AND UPJOHN INC II 7/6/1993 CHATTEM CHEMICALS INC I III III 3/30/1989 6/29/1993 SCHUPBACH AG OY PREMIX LTD I A I IV III III III 6/14/1993 6/10/1993 7/1/1993 6/26/1991 NOVILLE ESSENTIAL OIL CO INC PHILLIPS PLASTICS CORP WHEATON PHARMATECH SCHUPBACH AG III 6/24/1993 BASF AKTIENGESELLSCHAFT III 6/24/1993 BASF AKTIENGESELLSCHAFT STATUS Type SUBMIT DATE III 6/24/1993 HOLDER BASF AKTIENGESELLSCHAFT SUBJECT

4Q2012

ULTRAPEK A 1000 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY ULTRAPEK A 2000 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY ULTRAPEK A 3000 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY FLAVOR AN106248 MANUFACTURED IN SOUTH PLAINFIELD, NEW JERSEY DUST CAP, ACTUATOR AND HOUSING MANUFACTURED IN MENOMONIE, WISCONSIN N4003-45 PINK MANUFACTURED IN SALISBURY, MARYLAND COMPOUND PACKAGING MATERIAL FOR NICOTIN-TTS MANUFACTURED IN BURGDORF, SWITZERLAND TRANSDERM-NITRO TTS BACKING FILM MANUFACTURED IN BURGDORF, SWITZERLAND PREWHITE PE 10-50,PREWHITE PP 22-50 AND PREWHITE PE 16-50 MANUFACTURED IN RAJAMAKI, FINLAND HYDROXYAMPHETAMINE HYDROBROMIDE MANUFACTURED IN SOMERVILLE, NEW JERSEY CARBOXYLIC ACID MANUFACTURED IN HIARAKATA CITY, OSAKA, JAPAN AMINOBISAMIDE-HYDROCHLORIDE MANUFACTURED IN LINZ, AUSTRIA FACILITY AND OPERATING PROCEDURES IN STOCKHOLM, SWEDEN FACILITY AND OPERATING PROCEDURES AT THE BRUNNA FACILITY IN KUNGSANGEN, SWEDEN FACILITY AND OPERATING PROCEDURES IN STRANGNAS, SWEDEN SELEGILINE HYDROCHLORIDE MANUFACTURED IN MINDEN, GERMANY 100319 AS MB MANUFACTURED IN TERRE HAUTE, INDIANA, DERIDDER, LOUISIANA AND MESSANCY, BELGIUM 100320 AS MB MANUFACTURED IN TERRE HAUTE, INDIANA, DERIDDER, LOUISIANA AND MESSANCY, BELGIUM SICOLEN BLUE 69-0964 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY RAKUSOL WHITE 00-2207 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY RAKUSOL BLUE 62-9607 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY RAKUSOL BLUE 70-9007 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY PHARMACEUTICAL AEROSOL CANS MANUFACTURED IN CARY, NORTH CAROLINA GLAMINATE TUBES GS-1004-11 MANUFACTURED IN NEENAH, WISCONSIN ANTINEOPLASTON AS2-1 INJECTIONS MANUFACTURED IN STAFFORD, TEXAS

PHARMACEUTICAL WORKS POLPHARMA SA TINIDAZOLE MANUFACTURED IN STAROGARD GDANSKI, POLAND

CIPROFLOXACIN ORAL NEW DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN WUPPERTAL, GERMANY MARVAL M-800 NATURAL MANUFACTURED IN MAMARONECK, NEW YORK Page

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4Q2012EXCEL DMF# 10355 I 10356 I 10357 A 10358 I 10359 10360 10361 I 10362 I 10363 10364 10365 10366 10367 10368 10369 10370 I 10371 10372 10373 10374 10375 I 10376 I 10377 I 10378 A 10379 10380 10381 A 10382 10383 A I II II 7/22/1993 7/30/1993 PEPTOSYN INC I I II V II 7/23/1993 7/13/1993 7/9/1993 V 7/29/1993 INTERNATIONAL PHARMACEUTICAL AEROSOL CONSORTIUM TOXICOLOGY TESTING BIO RAD LABORATORIES INC OMJ PHARMACEUTICALS INC MITSUBISHI TANABE PHARMA CORP I 7/21/1993 TOKUYAMA SODA CO LTD II 7/26/1993 ICN HUNGARY COMPANY LTD I I I I II II I II I 6/28/1993 11/2/1993 7/15/1993 7/21/1993 7/26/1993 SCICLONE PHARMACEUTICALS SYNCHEM CHEMICALS PRIVATE LTD ALTAIRE PHARMACEUTICALS INC ZENTIVA, S.A. GENZYME CORP I I I A I I I II I II III III I II III 7/19/1993 7/19/1993 7/16/1993 7/21/1993 7/16/1993 7/20/1993 7/20/1993 7/14/1993 II 7/15/1993 I I III II IV 5/24/1993 7/14/1993 7/8/1993 ADRIAPLAST SPA IROTEC LABORATORIES LTD VAN GELDER COATING BV I 7/12/1993 DIOSYNTH BV III 5/12/1993 TIM PLASTICS INC III 7/9/1993 TECHNICOTE STATUS Type SUBMIT DATE III 6/8/1993 HOLDER H AND N CHEMICAL CO SUBJECT

4Q2012

PRESSURE SENSITIVE CODED POLYTAC 5135-1 MANUFACTURED IN TOTOWA, NEW JERSEY PACKAGING MATERIALS MANUFACTURED IN MIAMISBURG, OHIO, TERRE HAUTE, INDIANA, CUYAHOGA FALLS, OHIO AND CORONA, CALIFORNIA HIGH DENSITY PLASTICS BOTTLES FOR DRUG PACKAGING MANUFACTURED IN NORTH EAST, MARYLAND FACILITIES AND OPERATING PROCEDURES A DIOSYNTH FRANCE S.A. IN USINE SAINTCHARLES ERAGNY-SUR-EPTE, FRANCE ALKORPACK P/S MANUFACTURED IN MONFALCONE, ITALY DICLOFENAC SODIUM MANUFACTURED IN LITTLE ISLAND, CORK, IRELAND

GELROFLEX ALU-PET 100 MICRONS-2S REF: 154/155 MANUFACTURED IN APELDOORN, THE NETHERLANDS. UNIVERSITY OF PENNSYLVANIA SCHOOL OF LR-3001 MANUFACTURED IN FOSTER CITY, CALIFORNIA MEDECINE GREAT LAKES CHEMICAL CORP ISOFLURANE MANUFACTURED IN WEST LAFAYETTE, INDIANA. GREAT LAKES CHEMICAL CORP ISO TEX DIAGNOSTICS KURARAY AMERICA INC AMPACET CORP CRODA UNIVERSAL LTD CRODA UNIVERSAL LTD COURTESY MED TEK FACILITY FOR THE MANUFACTURE OF ISOFLURANE IN WEST LAFAYETTE, INDIANA. IODINE-125 MANUFACTURED IN FRIENDSWOOD, TEXAS. ETHYLENE/VINYL ALCOHOL COPOLYMERS MANUFACTURED IN PASADENA, TEXAS. 10005 AS MB MANUFACTURED IN TARRYTOWN, NEW YORK. MANUFACTURING FACILITIES AND OPERATING PROCEDURES IN LEEK, GREA BRITIAN. CROSSENTIAL LF100 MANUFACTURED IN LEEK, GREA BRITIAN. PLASTIC INJECTION MOLDED COMPONENTS FOR HUMAN DRUGS AND BIOLOGICS AS MFG IN BUFFALO GROVE, IL THYMOSIN ALPHA I (BULK DRUG) MANUFACTURED IN FOSTER CITY, CALIFORNIA. KETOROLAC TROMETHAMINE MANUFACTURED IN ANKLESHWAR, GUJARA, INDIA. FACILITIES AND OPERATING PROCEDURES IN HOLBROOK, NEW YORK. PENTOXIFYLLINE MANUFACTURED IN HLOHOVEC, SLOVAKIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LIESTAL, SWITZERLAND. MEXILETINE HYDROCHLORIDE USP BULK MANUFACTURED IN TISZAVASVARI, HUNGARY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF SILICA (AMORPHOUS, FUMED) IN TOKUYAMA, YAMAGUCHI, JAPAN. SAFETY DATA ON HFA-227 (1,1,1,2,3,3,3 HEPTAFLUOROPROPANE).

DEAE BIO-GEL A GEL MANUFACTURED IN RICHMOND, CALIFORNIA STERILE MFG PROCESSES AS PRODUCED IN SAN GERMAN,PUERTO RICO DILTIAZEM HYDROCHLORIDE (PROCESS C) MANUFACTURED IN ONODA CITY, YAMAGUCHI, JAPAN TOLONIUM CHLORIDE (TOLUIDINE BLUE-O) MANUFACTURED IN TUCKAHOE, NEW YORK

PHARMACEUTICAL WORKS POLPHARMA SA ACETAZOLAMIDE MANUFACTURED IN STAROGARD GDANSKI, POLAND

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4Q2012EXCEL DMF# 10384 A 10385 10386 I 10387 10388 I 10389 10390 I 10391 I 10392 I 10393 I 10394 10395 I 10396 10397 I 10398 I 10399 10400 10401 I 10402 10403 10404 10405 10406 10407 I 10408 10409 I 10410 A 10411 10412 A I III III 8/6/1993 8/16/1993 PMS CONSOLIDATED WESTLAKE POLYMERS CORP II 8/13/1993 SYNTHOKEM LABS PRIVATE LTD I IV IV 8/10/1993 8/6/1993 I I I I I II II II II III III 8/4/1993 8/4/1993 8/4/1993 8/6/1992 8/9/1993 8/9/1993 GANES CHEMICALS INC GANES CHEMICALS INC GANES CHEMICALS INC HUMATECH HEINKE TECHNOLOGY INC PAPIERFABRIK DIV SCHOELLER AND HOESCH GMBH RESOURCES INDUSTRY INC TAKASAGO INTERNATIONAL CORP N I II I 6/17/1993 8/3/1993 NOT AN ASSIGNED NUMBER TAIHO PHARMACEUTICAL CO INC SINTENOVO SA DE CV III 8/3/1993 PMS CONSOLIDATED A II III 6/17/1993 8/3/1993 TAIHO PHARMACEUTICAL CO LTD HELVOET PHARMA MARYLAND TEGAFUR AS MANUFACTURED IN SAITAMA, JAPAN I I III 8/2/1993 7/16/1993 CIBA GEIGY MEXICANA SA DE CV EUROPLAZ LTD I 7/21/1993 MERCK AND CO INC III 7/19/1993 WADDINGTON JAYCARE LTD III 8/2/1993 SABIC PETROCHEMICALS BV I II IV 7/29/1993 7/29/1993 LONZA RIVERSIDE TAKASAGO INTERNATIONAL CORP PROPYLHEXEDRINE MANUFACTURED IN CONSHOHOCKEN, PENNSYLVANIA I II II 7/28/1993 7/30/1993 PHARMACIA AND UPJOHN INC 17-DESOXY OXIDO MANUFACTURED IN KALAMAZOO, MICHIGAN PHARMACEUTICAL WORKS POLPHARMA SA TOLBUTAMIDE MANUFACTURED IN STAROGARD GDANSKI, POLAND C II II 8/2/1993 7/30/1993 TEVA PHARMACEUTICAL INDUSTRIES LTD BUTORPHANOL TARTRATE MANUFACTURED IN OPAVA, CZECH REPUBLIC PHARMACEUTICAL WORKS POLPHARMA SA ACETYLSALICYLIC ACID MANUFACTURED IN STAROGARD GDANSKI, POLAND STATUS Type SUBMIT DATE II 7/30/1993 HOLDER SUBJECT PHARMACEUTICAL WORKS POLPHARMA SA CHLORPROPAMIDE MANUFACTUERED IN STAROGARD GDANSKI, POLAND

4Q2012

TAK-90516 SOLID EXTRACT TAMARIND FLAVOR MANUFACTURED IN TETERBORO, NEW JERSEY SABIC LDPE 2304AN00, STAMYLAN 1808AN00, AND STAMLEX 9089F MANUFACTURED IN BEEK, THE NETHERLANDS JAYSQUARE CONTAINERS MANUFACTURED IN NORTH SHIELDS, TYNE AND WEAR, ENGLAND MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LE PUY CEDEX, FRANCE. FACILITY AND OPERATING PROCEDURES IN PUEBLA, MEXICO PLASTIC PACKAGING MATERIAL MANUFACTURED IN SOUTHMINSTER, ESSEX, ENGLAND

RUBBER CLOSURE FORMULATION C6201-45 GREEN MANUFACTURED IN SALSBURY, MARYLAND COLORANTS FOR PACKAGING, 042098 JPMB AND 07663 JFFD AS MANUFACTURED IN SOMERSET, NEW JERSEY UFT CAPSULES (TEGAFUR AND URACIL) MANUFACTURED IN TOKUSHIMA, JAPAN FACILITIES, PERSONNEL AND OPERATING PROCEDURES AT THE NAUCALPAN (MEXICO) PLANT IODINATED GLYCEROL AZEO MANUFACTURED IN CARLSTADT, NEW JERSEY IODINATED GLYCEROL SOLUTION MANUFACTURED IN CARLSTADT, NEW JERSEY IODINATED GLYCEROL CONCENTRATE MANUFACTURED IN CARLSTADT, NEW JERSEY IBOGAINE HYDROCHLORIDE MANUFACTURED IN LOUVAIN-LA-NEUVE, BELGIUM VCA5 VAGINAL CREAM APPLICATOR MANUFACTURED IN LINCOLN, NEBRASKA GEFOLUX TDS/M 50, 75, 10UM (ONE SIDE ALUMINIZED) AS MANUFACTURED IN GERNSBACH, GERMANY MICROCRYSTALLINE CELLULOSE MANUFACTURED IN LAFAYETTE, INDIANA TAK-920471 NATURAL AND ARTIFICIAL TAMARIND FLAVOR MANUFACTURED IN TETERBORO, NEW JERSEY METHOCARBAMOL MANUFACTURED IN SANATHNAGAR, HYDERABAD, ANDHRA PRADESH, INDIA 152 LFD COLORANT MANUFACTURED IN GARDENA, CALIFORNIA LOW DENSITY POLYETHYLENE (LDPE) RESINS MANUFACTURED IN SULPHUR, LOUISIANA

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4Q2012EXCEL DMF# 10413 A 10414 10415 10416 10417 10418 10419 10420 10421 I 10422 10423 10424 I 10425 10426 I 10427 I 10428 I 10429 10430 10431 I 10432 I 10433 I 10434 I 10435 A 10436 10437 10438 10439 10440 10441 10442 10443 A I I A A I I I III I III III II IV II II 8/26/1993 8/26/1993 8/26/1993 8/26/1993 8/24/1993 8/27/1993 8/17/1993 8/25/1993 GEON CO FUJI GLASS CO LTD FUJI GLASS CO LTD FUJI GLASS CO LTD WYCKOFF CHEMICAL CO INC PHARMECO LABORATORIES INC SIGMA F AND D DIV LTD ISOCHEM SAS III 8/6/1993 BASF COLOR SOLUTIONS GERMANY GMBH III 8/17/1993 PMS CONSOLIDATED III 8/11/1993 BASF AKTIENGESELLSCHAFT II 8/17/1993 ANDRULIS RESEARCH CORP A I III II III 8/18/1993 8/18/1993 8/20/1993 MYLAN TECHNOLOGIES INC IMUTEC CORP BESPAK PLC III 8/5/1993 CREST FLEXIBLE PACKAGING LTD III 8/5/1993 CREST FLEXIBLE PACKAGING LTD I III III 8/16/1993 8/17/1993 DCP-LOHJA INC DSM POLYMERS I I III II IV 3/11/1993 8/11/1993 8/12/1993 I A A A I I I II II II II I I I IV 8/9/1993 8/10/1993 8/13/1993 8/16/1993 8/13/1993 6/2/1993 7/30/1993 8/3/1993 ARCHIMICA SPA ONO PHARMACEUTICAL CO LTD TAKEDA PHARMACEUTICAL CO LTD SAFC BIOSCIENCES INC TAKEDA CHEMICAL INDUSTRIES LTD GALEN LTD PHARMACIA AND UPJOHN INC QUEST INTERNATIONAL FLAVORS AND FOOD INGREDIENTS CO TICONA GMBH HOECHST MARION ROUSSEL SA TAKASAGO INTERNATIONAL CORP STATUS Type SUBMIT DATE II 8/13/1993 HOLDER SYNTHOKEM LABS PRIVATE LTD SUBJECT

4Q2012

GUAIFENESIN MANUFACTURED IN SANATHNAGAR, HYDERABAD, ANDHRA PRADESH, INDIA BUSPIRONE HYDROCHLORIDE MANUFACTURED IN VARESE, ITALY ALPROSTADIL ALFADEX I.V. MANUFACTURED IN JOTO, JAPAN LEUPROLIDE ACETATE MANUFACTURED IN HIKARI-CITY, YAMAGUCHI, JAPAN EX-CELL 301 MANUFACTURED IN DENVER, PENNSYLVANIA FACILITIES AND OPERATING PROCEDURES IN HIKARI-CITY, YAMAGUCHI, JAPAN FACILITY AND OPERATING PROCEDURES IN CRAIGAVON, NORTHERN IRELAND FACILITY, PERSONNEL AND OPERATING PROCEDURES IN STOCKHOLM, SWEDEN ARTIFICIAL BANANA FLAVOR 81.605P, DY-02041 MANUFACTURED IN OWINGS MILLS, MARYLAND NYLON 6,6 MANUFACTURED IN BISHOP, TEXAS AND FLORENCE, KENTUCKY BETAMETHASONE SODIUM PHOSPHATE MANUFACTURED IN VERTOLAYE, FRANCE TAK-920444 NATURAL ORANGE EXTRACT WONF MANUFACTURED IN TETERBORO, NEW JERSEY. RELEASE FILMS MANUFACTURED IN DIXON, ILLINOIS PACKAGING MATERIAL STAMYLAN HD 7058Z MANUFACTURED IN BEEK, THE NETHERLANDS PACKAGING MATERIAL FOR PEPCIDIN 20 MG AND 40 MG AS MANUFACTURED IN GILLINGHAM, KENT, ENGLAND 18779-010-010 PAPER/PE/FOIL/PE BASE 10000 PACKING MATERIAL AS MANUFACTURED IN GILLINGHAM, KENT, ENGLAND 2226 LINER (ESUB) AS MANUFACTURED IN ST. ALBANS, VERMONT PREMIX A FOR VIRULIZIN-2B MANUFACTURED IN SCARBOROUGH, ONTARIO, CANADA BESPAK BK636 PHARMACEUTICAL ORAL ACTUATOR MANUFACTURED IN NORFOLK, ENGLAND BIS-ETHYL NORSPERMINE TETRAHYDROCHLORIDE (BENS.4HCL) MANUFACTURED IN BELTSVILLE, MARYLAND SICOLEN BLUE 69-1625 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY COLORANTS 502617 JPMBC, 502622 JPMBC, 503986 JPMBC, 504240 JPMBC, 41P997 CMB AND 21P5030 CMB MANUFACTURED IN ELK GROVE VILLAGE, ILLINOIS EUTHYLEN WHITE 00-1905 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY GEON 87781-003, 87781-005 AND 87781-007 MANUFACTURED IN CLEVELAND, OHIO FACILITY AND OPERATING PROCEDURES IN TOKYO, JAPAN. GLASS TUBULAR VIALS MANUFACTURED IN TOKYO, JAPAN. AMPULES MANUFACTURED IN TOKYO, JAPAN PSEUDOEPHEDRINE SULFATE MANUFACTURED IN SOUTH HAVEN, MICHIGAN. ZONYL FSO 100 MANUFACTURED IN LEXINGTON, MASSACHUSETTS. 2-DEOXYCYTIDINE MANUFACTURED IN SAINT LOUIS, MISSOURI. METHYL-3-FLAVONE-8-CARBOXYLIC ACID MANUFACTURED IN GENNEVILLIERS, FRANCE.

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4Q2012EXCEL DMF# 10444 I 10445 10446 10447 10448 10449 I 10450 A 10451 10452 10453 10454 10455 10456 A 10457 10458 I 10459 I 10460 10461 10462 10463 10464 10465 10466 I 10467 I 10468 I 10469 10470 I 10471 10472 10473 I 10474 I I 8/28/1993 NIPPON PHARMACEUTICAL CHEMICALS CO LTD I I III II II 9/2/1993 9/10/1993 9/14/1993 I I II 9/10/1993 9/4/1993 YUHAN CORP CLARIANT LIFE SCIENCE MOLECULES UK LTD ECP ENICHEM POLYMERES FRANCE ICN HUNGARY COMPANY LIMITED LABORATOIRES SERONO SA II 8/27/1993 FINORGA SA II 9/13/1993 A A A I I A II II II I I III II 9/8/1993 9/8/1993 8/25/1993 8/25/1993 2/19/1993 9/2/1993 6/2/1993 PCAS PCAS INDENA SPA INDENA GRUPPO INVERNI DELLA BEFFA VINTAGE PHARMACEUTICAL INC FUJIMORI KOGYO CO LTD SUMITRA PHARMACEUTICALS AND CHEMICALS LTD NIPPON GOHSEI II 9/3/1993 PCR INC A II II 8/30/1993 9/7/1993 NV ORGANON FLUORO SEAL INC A I I I A III III III III III II 8/4/1993 8/16/1993 8/16/1993 8/16/1993 9/21/1994 8/9/1993 DANAPAK FLEXIBLES AS SOLVAY AND CIE SA SOLVAY AND CIE SA SOLVAY AND CIE SA DR REDDYS LABORATORIES INC FDC LTD II 8/30/1993 KANEKA CORP I I A I III III II I I 8/16/1993 8/25/1993 8/26/1993 9/1/1993 8/26/1993 STATUS Type SUBMIT DATE I 8/23/1993 HOLDER PEBOC DIVISION OF EASTMAN CHEMICAL (UK) LIMITED SOLVAY AND CIE SA SAM SEMCO PHARMACIA AND UPJOHN SUB PFIZER INC NIPPON GOHSEI CO LTD ORGANICHEM CORP SUBJECT FACILITY AND PROEDURES IN LLANGEFNI, ENGLAND. POLYPROPYLENE ELTEX P HS 200 MANUFACTURED IN SARRALBE, FRANCE. PACKAGING MATERIAL MANUFACTURED IN MONTE CARLO, MONACO. HYDROCORTISONE BUTYRATE MANUFACTURED IN KALAMAZOO, MICHIGAN

4Q2012

FACILITY AND OPERATING PROCEDURES IN UTO, KUNAMOTO PREFECTURE, JAPAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN OSLO, NORWAY. (4S,6S)-5, 6-DIHYDRO-4-HYDROXY-6-METHYL-4H-THIENO[2,3-B]THIOPYRAN 7,7-DIOXIDE (HSOT) MANUFACTURED IN HYOGO, JAPAN COMPOUND PACKAGING MATERIAL MANUFACTURED IN ODENSE, DENMARK POLYPROPYLENE ELTEX A 4019-X1869 MANUFACTURED IN SARRALBE, FRANCE. POLYPROPYLENE ELTEX P HS 250 MANUFACTURED IN SARRALBE, FRANCE POLYPROPYLENE ELTEX P HV 252 MANUFACTURED IN SARRALBE, FRANCE HDPE BOTTLES MANUFACTURED IN BRISTOL, TENNESSEE ECONAZOLE NITRATE MANUFACTURED IN ROHA, DIST. RAIGAD, MAHARASHTRA STATE, INDIA. MIRTAZAPINE MANUFACTURED IN OSS, THE NETHERLANDS APF-30M (DODECAFLOUROPENTANE) MANUFACTURED IN ALLENTOWN, PENNSYLVANIA MEDICAL GRADE DODECAFLUOROPENTANE MANUFACTURED IN GAINESVILLE, FLORIDA DICYCLOMINE HYDROCHLORIDE MANUFACTURED IN LIMAY, FRANCE FOR PCAS DESIPRAMINE HYDROCHLORIDE MANUFACTURED IN LIMAY, FRANCE FOR PCAS 10-DEACETYLBACCATIN III (ESUB) MANUFACTURED IN SETTALA, (MI), ITALY FACILITY AND OPERATING PROCEDURES IN SETTALA (MI), ITALY FACILITY AND OPERATING PROCEDURES IN CHARLOTTE, NORTH CAROLINA PLASTIC FILM BAG MANUFACTURED IN NABARI-CITY, JAPAN DILTIAZEM HYDROCHLORIDE MANUFACTURED IN ANDHRA PRADESH, INDIA 2-N-BUTYL-4-CHLORO-1H-IMIDAZOLE-5-CARBOXALDEHYDE MANUFACTURED IN KUNAMOTO, JAPAN 2-BUTYL-4(5)-CHLORO-1H-IMIDAZOLE-5(4)-CARBOXALDEHYDE MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE FACILITY AND OPERATING PROCEDURES IN ANSANSHI, KYONGGI-DO, SOUTH KOREA BENZOCAINE MANUFACTURED IN MANCHESTER, UNITED KINGDOM ERACLENE MP94 MANUFACTURED IN PORTO TORRES, ITALY CHLOROQUINE PHOSPHATE MANUFACTURED IN TISZAVASVARI, HUNGARY STERILE WATER FOR INJECTION MANUFACTURED BY PHARMA HAMELN GMBH IN HAMELN, FEDERAL REPUBLIC OF GERMANY AND PACKAGED BY LABORATOIRES SERONO SA IN AUBONNE, SWITZERLAND FACILITIES AND OPERATING PROCEDURES IN HIGASHIOSAKA CITY, OSAKA, JAPAN

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4Q2012EXCEL DMF# 10475 10476 10477 I 10478 I 10479 I 10480 I 10481 I 10482 10483 I 10484 I 10485 10486 I 10487 I 10488 10489 I 10490 I 10491 10492 A 10493 10494 10495 10496 I 10497 10498 10499 10500 10501 10502 10503 I 10504 I II 9/29/1993 NAPRO BIOTHERAPEUTICS INC I A A A I I II II II III III IV IV 9/24/1993 9/28/1993 9/29/1993 9/23/1993 9/23/1993 9/21/1993 9/21/1993 GEDEON RICHTER USA INC GRAIN PROCESSING CORP CATALENT PHARMA SOLUTIONS LLC BEATSON CLARK PLC BEATSON CLARK PLC J MANHEIMER INC J MANHEIMER INC A I A II I IV II 9/23/1993 9/27/1993 9/23/1993 9/24/1993 I I II 9/24/1993 9/15/1993 QUALITY CHEMICALS INC SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL NV ORGANON CTRC RESEARCH FDN CREMER OLEO GMBH AND CO KG HOFFMANN LA ROCHE INC III 9/13/1993 HELVOET PHARMA MARYLAND I III II 9/17/1993 9/21/1993 ROLLPRINT PACKAGING PRODUCTS INC SEPRACOR INC III 9/20/1993 A II III 9/21/1993 9/15/1993 HAFSLUND NYCOMED PHARMA AG SWIFT ADHESIVES DIV REICHHOLD CHEMICALS INC AMPACET CORP PODOPHYLLOTOXIN MANUFACTURED IN LINZ, AUSTRIA SWIFT 2H041 ADHESIVE MANUFACTURED IN DOWNERS GROVE, ILLINOIS III 9/8/1993 BASF AKTIENGESELLSCHAFT I III III 9/8/1993 9/8/1993 BASF AKTIENGESELLSCHAFT BASF AKTIENGESELLSCHAFT I 9/17/1993 HOFFMANN LA ROCHE INC I 9/2/1993 NOVO NORDISK A/S II 9/20/1993 PEPTECH EUROPE A/S II 9/17/1993 ROCHE DIAGNOSTICS GMBH STATUS Type SUBMIT DATE I A I II I 9/3/1993 9/17/1993 9/3/1993 HOLDER NIPPON TERPENE CHEMICAL CO LTD NIPPON KAYAKU CO LTD LEO PHARMACEUTICAL PRODUCTS LTD SUBJECT FACILITY AND OPERATING PROCEDURES IN KOBE, JAPAN ETOPOSIDE PHOSPHATE AS MFG. IN TOKYO, JAPAN

4Q2012

WEXPORT LTD. FACILITIES IN LITTLE ISLAND, CORK, IRELAND FOR THE MANUFACTURE OF HEPARIN SODIUM FRUCTOSE-1.6-BISPHOSPHATE MANUFACTURED IN PENZBERG, FEDERAL REPUBLIC OF GERMANY (D-ALA1)-PEPTIDE T AMIDE, HYDROCHLORIDE MANUFACTURED IN COPENHAGEN, DENMARK FACILITIES IN BAGSVATERD, KALUNDBORG, COPENHAGEN, SOEBERG, HILLEROED AND VATERLOESE, DENMARK FACILITY AND OPERATING PROCEDURES IN WELWYN GARDEN CITY, HERTFORDSHIRE, ENGLAND NOVOLEN 1100 RC MANUFACTURED IN LUDWIGSHAFEN, GERMANY TERLUX 2802 TR TRANSPARENT 27768 MANUFACTURED IN LUDWIGSHAFEN, GERMANY TERLUX 2802 TR TRANSPARENT 28348 MANUFACTURED IN LUDWIGSHAFEN, GERMANY

180132 SKIN TONE POLYETHYLENE MASTERBACH MANUFACTURED IN TARRYTOWN, NEW YORK RPP #26-1067 PACKAGING MATERIAL MANUFACTURED IN ADDISON, ILLINOIS BLUE TRISACRYL AND BLUE TRISACRYL PLUS MANUFACTURED IN VILLENEUVE LA GARENNE, FRANCE RUBBER CLOSURE FORMULATION B5021-45 GRAY MANUFACTURED IN SALISBURY, MARYLAND FACILITY AND OPERATING PROCEDURES IN DAYTON, OHIO TICLOPIDINE HYDROCHLORIDE MANUFACTURED IN FLORENCE, ITALY BUDESONIDE MANUFACTURED IN OSS, THE NETHERLANDS FACILITIES, SITE AND PERSONNEL IN SAN ANTONIO, TEXAS MIGLYOL 829 MANUFACTURED IN WITTEN, GERMANY NITOMAN (TETRABENAZINE) TABLETS MANUFACTURED IN DALRY, SCOTLAND AND WELWYN GARDEN CITY, ENGLAND FLUTAMIDE MANUFACTURED IN BUDAPEST, HUNGARY ETHYL ALCOHOL PRODUCTS MANUFACTURED IN MUSCATINE, IOWA IBUPROFEN SOFTGELS, 200 MG. MANUFACTURED IN ST. PETERSBURG, FLORIDA AMBER GLASS CONTAINERS MANUFACTURED IN ROTHERHAM, ENGLAND WHITE FLINT GLASS CONTAINERS MANUFACTURED IN ROTHERHAM, ENGLAND NATURAL CHERRY WONF 606948 MANUFACTURED IN LONG ISLAND CITY, NEW YORK NATURAL AND ARTIFICIAL CHERRY FLAVOR 606947 MANUFACTURED IN LONG ISLAND CITY, NEW YORK PACLITAXEL DRUG SUBSTANCE MANUFACTURED IN BOULDER, COLORADO

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4Q2012EXCEL DMF# 10505 I 10506 I 10507 10508 10509 10510 I 10511 10512 I 10513 10514 A 10515 10516 10517 10518 10519 10520 10521 10522 I 10523 I 10524 10525 10526 I 10527 10528 10529 10530 10531 10532 10533 10534 10535 I 10536 10537 A I II III 10/18/1993 10/25/1993 PHARMACIA AND UPJOHN SUB PFIZER INC DSM POLYMERS I I I I I A I A II II II II II II I II I 8/31/1993 10/13/1993 10/14/1993 8/14/1993 10/19/1993 10/15/1993 9/30/1993 10/21/1993 10/15/1993 FINE CHEMICALS CORP LTD SIGMA F AND D DIV LTD IROTEC LABORATORIES LTD MEDEA RESEARCH LABORATORIES INC ARCHIMICA SPA DEAD SEA BROMINE CO LTD VANCHEM INC MEDICHEM SA WEST GRAND DE MEXICO S DE RL DE CV A I IV I III 10/12/1993 10/14/1993 10/6/1993 CREMER OLEO GMBH AND CO KG NOVARTIS PHARMA AG HELVOET PHARMA MARYLAND II 10/7/1993 UPSHER SMITH LABORATORIES INC A I A A I I I II II II II II II I III 10/8/1993 10/5/1993 9/30/1993 9/30/1993 10/8/1993 9/30/1993 10/5/1993 10/8/1993 LEO PHARMA AS RANBAXY LABORATORIES LTD SIFAVITOR SRL SIFAVITOR SRL NV ORGANON ORGAMOL SA SANDOZ AG INTERNATIONAL TRADING CORP A II II 10/5/1993 10/8/1993 GRACEWAY PHARMACEUTICALS LLC LEO PHARMA AS I I II 9/24/1993 10/4/1993 I A I II IV I II 9/30/1993 9/23/1993 9/21/1993 9/27/1993 BTR SEPARATIONS CREMER OLEO GMBH AND CO KG LONZA LTD LIQUID CARBONIC INDUSTRIES CORP BULK GASES BTR SEPARATIONS LABORATORIOS SERONO SA III 9/7/1993 FERRO CORP STATUS Type SUBMIT DATE II 9/29/1993 HOLDER LONZA LTD SUBJECT

4Q2012

2-BUTYL-5-CHLORO-1H-IMIDAZOLE-4-CARBOXALDEHYDE MANUFACTURED IN VISP, SWITZERLAND NPPOONPO4NA (ALTERNATIVELY X53-041 OR CPC27-4555) MANUFACTURED IN EVANSVILLE, INDIANA ZORBAX MANUFACTURED IN DEEPWATER, NEW JERSEY. IMWITOR 742 MANUFACTURED IN WITTEN, GERMANY FACILITY AND OPERATING PROCEDURES IN VISP, SWITZERLAND NITRIC OXIDE IN NITROGEN GAS MIXTURE PRODUCED IN OAK BROOK, ILLINOIS FACILITIES AND OPERATING PROCEDURES IN MILAN, ITALY. BACTERIOSTATIC SODIUM CHLORIDE INJECTION MANUFACTURED IN AUBONNE, SWITZERLAND PIRBUTEROL ACETATE MANUFACTURED IN PITHIVIERS, CEDEX, FRANCE CALCIPOTRIENE HYDRATE DRUG SUBSTANCE (ESUB) MANUFACTURED IN BALLERUP, DENMARK CALCIPOTRIENE CREAM DRUG PRODUCT MANUFACTURED IN BALLERUP, DENMARK RANITIDINE HYDROCHLORIDE MANUFACTURED IN DISTT. ROPAR, PUNJAB, INDIA LOPERAMIDE HYDROCHLORIDE MANUFACTURED IN MILAN, ITALY MICONAZOLE NITRATE MANUFACTURED IN MILAN, ITALY DANAPAROID SODIUM MANUFACTURED IN OSS, THE NETHERLANDS MOEXIPRIL HYDROCHLORIDE MANUFACTURED IN EVIONNAZ, SWITZERLAND FACILITIES AND PROCEDURES IN NUREMBERG, GERMANY PROLEN XM6150K, HY6100, AND SM6100K MANUFACTURED BY POLIBRASIL S.A. IN RIO DE JANEIRO, BRAZIL NIACOR (IMMEDIATE-RELEASE NIACIN TABLETS) MANUFACTURED IN MINNEAPOLIS, MINNESOTA SOFTISAN 649 MANUFACTURED IN WITTEN, GERMANY FACILITY AND OPERATING PROCEDURES IN DORVAL, QUEBEC, CANADA RUBBER CLOSURE FORMULATION B5301-50 GRAY MANUFACTURED IN SALISBURY, MARYLAND NICOTINE POLACRILEX MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA DEOXYRIBONUCLEASE I (PROD. NO. D 5025) MANUFACTURED IN ST. LOUIS, MISSOURI SELEGILINE HYDROCHLORIDE MANUFACTURED IN LITTLE ISLAND, CORK, IRELAND WARFARIN SODIUM MANUFACTURED IN PORT JEFFERSON STATION, NEW YORK NITRO-THIAZOLINEBULK MANUFACTURED IN ORIGGIO, ITALY. MAGNESIUM HYDROXIDE MANUFACTURED IN D.N. ARAVA, ISRAEL FACILITY AND OPERATING PROCEDURES IN LOCKPORT, NEW YORK CLOZAPINE MANUFACTURED IN CELRA (GERONA), SPAIN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN VERACRUZ, MEXICO. ESTRADIOL MANUFACTURED IN KALAMAZOO, MICHIGAN STAMYLAN P 112MN40 MANUFACTURED IN BEEK, THE NETHERLANDS

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4Q2012EXCEL DMF# 10538 10539 10540 I 10541 10542 I 10543 10544 10545 10546 10547 10548 10549 10550 I 10551 10552 10553 10554 I 10555 I 10556 I 10557 I 10558 10559 10560 I 10561 10562 10563 I 10564 10565 A 10566 10567 10568 10569 10570 I I I I I I I II II II 11/8/1993 11/5/1993 11/9/1993 11/12/1993 11/4/1993 ALBERT DAVID LTD MAROPACK AG PHARMACIA AND UPJOHN INC RANBAXY LABORATORIES LTD DAIICHI ASUBIO PHARMA CO LTD I II II 10/29/1993 11/12/1993 A A III III III 11/3/1993 11/4/1993 10/22/1993 LOPAREX LLC PHILLIPS SUMIKA POLYPROPYLENE CO N A III I 10/27/1993 11/3/1993 NOT AN ASSIGNED NUMBER UNITED CLOSURES AND PLASTICS PLC SENN CHEMICALS CLOSURES MANUFACTURED IN NORWICH, ENGLAND III 10/18/1993 HARGRO PACKAGING II 9/30/1993 GENZYME FINE CHEMICALS III 10/29/1993 REXHAM CONTAINERS I I I I I III III 9/29/1993 10/28/1993 10/21/1993 10/29/1993 SYNBIOTICS LTD REGIS CHEMICAL CO DANAPAK FLEXIBLES SILGAN PLASTICS CANADA INC I I I I A I A II II III II II II II I 10/26/1993 10/22/1993 10/20/1993 10/25/1993 10/25/1993 10/26/1993 10/26/1993 10/22/1993 MALLINCKRODT CHEMICAL INC KYOWA HAKKO KOGYO CO LTD AMPACET CORP ESTEVE QUIMICA SA ESTEVE QUIMICA SA SELOC AG PCAS VALOIS I II II 10/25/1993 10/25/1993 3M PHARMACEUTICALS CYGNUS INC STATUS Type SUBMIT DATE I I III III V 10/25/1993 10/25/1993 10/25/1993 HOLDER DSM POLYMERS DSM POLYMERS 3M PHARMACEUTICALS SUBJECT STAMYLAN HD 8621 MANUFACTURED IN BEEK, THE NETHERLANDS STAMYLAN LD 2102T MANUFACTURED IN BEEK, THE NETHERLANDS

4Q2012

PRECLINICAL SAFETY OF THE ADHESIVE SYSTEM FOR THE TRANSDERMAL DRUG PRODUCTS A-81418 TRANSDERMAL PACH A-81418 MANUFACTURED IN ST. PAUL, MINNESOTA ESTRADIOL-NORETHINDRONE TRANSDERMAL DELIVERY SYSTEM MANUFACTURED IN REDWOOD, CALIFORNIA BRAIN NARIURETIC PEPTIDE MANUFACTURED IN ST. LOUIS, MISSOURI L-GLUTAHIONE REDUCED (ORAL GRADE) MANUFACTURED IN HOFU CITY, JAPAN LT-70279 PEACH POLYETHYLENE MASTERBACH. METOPROLOL FUMARATE MANUFACTURED IN CELRA (GIRONA), SPAIN. METOPROLOL SUCCINATE MANUFACTURED IN CELRA (GIRONA), SPAIN. CHLOROTRIANISENE MANUFACTURED IN LIMAY, FRANCE MEPENZOLATE BROMIDE MANUFACTURED IN LIMAY, FRANCE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LE NEUBOURG, FRANCE. FACILITIES AND OPERATING PROCEDURES IN VADODARA (GUJARA), INDIA. FACILITY AND OPERATING PROCEDURES IN MORTON GROVE, ILLINOIS. COMPOUND PACKAGING MATERIAL MANUFACTURED IN ODENSE, DENMARK. 100-300 R PHARMACEUTICAL BOTTLES MANUFACTURED IN SCARBOROUGH, ONTARIO, CANADA. 100-250 OB PHARMACEUTICAL BOTTLES MANUFACTURED IN SCARBOROUGH, ONTARIO, CANADA. SODIUM CHOLESTERYL SULPHATE MANUFACTURED IN HAVERHILL, SUFFOLK, ENGLAND PACKAGING MATERIAL CODE E-93PS-1 MANUFACTURED IN EDINBURGH, IN OR FLEMINGTON, NJ

MANUFACTURING SITE, FACILITIES AND OPERATING PROCEDURES AND PERSONNEL IN DIELSDORF, SWITZERLAND BIORELEASE FILM LINER MANUFACTURED IN BEDFORD PARK, IL, IOWA CITY, IA MARLEX POLYPROPYLENE MANUFACTURED IN PASADANA, TEXAS

ROWO COATING GMBH FUR BESCHICHTUNG POLYESTER FILM 100 MICRON (ONE SIDE ALUMINIZED) MANUFACTURED IN HERBOLZHEIM, GERMANY ZAMBON GROUP SPA IOPAMIDOL MANUFACTURED IN VICENZA, ITALY SAFC BIOSCIENCES INC EX-CELL 300 (MBS) W/L-GLUTAMINE, HEPES, NAHC03, GALACTOSE W/O PHENOL RED (CAT. NO. 14035) FACILITY AND OPERATING PROCEDURES IN CALCUTTA, INDIA FACILITIES AND OPERATING PROCEDURES IN ZELL/LUCERNE, SWITZERLAND. BIZELESIN (U-77779) DRUG SUBSTANCE MANUFACTURED IN KALAMAZOO, MICHIGAN TERFENADINE MANUFACTURED IN DISTT. ROPAR, PUNJAB, INDIA SUN A0026 DRUG SUBSTANCE MANUFACTURED IN CHIBA-CITY, CHIBA, JAPAN

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4Q2012EXCEL DMF# 10571 10572 10573 10574 10575 10576 A 10577 10578 10579 10580 10581 10582 I 10583 10584 10585 I 10586 10587 I 10588 10589 I 10590 I 10591 I 10592 I 10593 A 10594 10595 10596 10597 10598 I 10599 10600 10601 10602 I 10603 I I 11/29/1993 NOVO NORDISK PHARMACEUTICALS INC I I A II II II II 11/29/1993 12/7/1993 12/8/1993 11/23/1993 ANGUS CHEMICAL CO JANSSEN PHARMACEUTICA NV SAFC BIOSCIENCES INC BIOCHEMICA OPOS SPA I I I I III I II II II 11/19/1993 11/29/1993 12/7/1993 12/7/1993 12/2/1993 II 11/30/1993 I 11/24/1993 LABORATORIOS APPLICACIONES FARMACEUTICAS DSM FINE CHEMICALS AUSTRIA NFG GMBH AND CO KG PERLOS OYJ PVC CONTAINER CORP LEO PHARMACEUTICAL PRODUCTS LEO PHARMACEUTICAL PRODUCTS GENZYME PHARMACEUTICALS II 11/24/1993 CYGNUS INC II 11/22/1993 LONZA RIVERSIDE A III II 11/18/1993 11/22/1993 FAULKNER EXPORT PACKAGING LTD LEO PHARMACEUTICAL PRODUCTS I II III 11/22/1993 11/9/1993 BOEHRINGER INGELHEIM PHARMA KG CEBAL VERPACKUNGEN GMBH AND CO KG I A III III III 10/27/1993 10/27/1993 12/1/1993 BASF AKTIENGESELLSCHAFT BASF SE INTRAPAC CORP I I I A A II IV II IV V II 11/8/1993 11/5/1993 11/16/1993 11/17/1993 11/19/1993 11/19/1993 ALDRICH CHEMICAL CO INC CARRUBBA INC KV PHARMACEUTICAL CO CREMER OLEO GMBH AND CO KG NERPHARMA SRL SCHUTZ AND CO STATUS Type SUBMIT DATE I I I I I I IV II I II II 11/4/1993 11/10/1993 11/11/1993 11/11/1993 11/17/1993 11/18/1993 HOLDER SUNTORY BIO PHARMA TECH CENTER ENCAPSULATION SYSTEMS INC 3V PARTECIPAZIONI INDUSTRIALI SPA 3V PARTECIPAZIONI INDUSTRIALI SPA BACHEM INC INTERPHARMA PRAHA A S SUBJECT MANUFACTURING SITE A THE CHIBA PLANT IN CHIBA-CITY, CHIBA, JAPAN DELTA STARCH 901 MANUFACTURED IN DARBY, PENNSYLVANIA UVASORB MET/C MANUFACTURED IN MOZZO, ITALY MANUFACTURING FACILITY IN MOZZO, ITALY DESLORELIN PAMOATE MANUFACTURED IN TORRANCE, CALIFORNIA

4Q2012

IODIPAMIDE DRUG SUBSTANCE MANUFACTURED IN PRAGUE, MODRANY, CZECH REPUBLIC. 2,5-DIHYDROXYBENZOIC ACID MANUFACTURED IN MILWAUKEE, WISCONSIN. FLAVOR CONCENTRATE # 48119 MANUFACTURED IN MILFORD, CONNECTICUT. MICONAZOLE VAGINAL CREAM MANUFACTURED IN ST. LOUIS, MISSOURI SOFTISAN 378 MANUFACTURED IN WITTEN, GERMANY STERILE AND NON-STERILE FACILITIES LOCATED IN MILAN, ITALY TRIPELENNAMINE HYDROCHLORIDE MANUFACTURED IN RAHDRUM, CO. WICKLOW, IRELAND NOVOLEN 1100 L MANUFACTURED IN LUDIWIGSHAFEN, GERMANY. ULTRADUR B 4520 MANUFACTURED IN LUDWIGSHAFEN, GERMANY COLLAPSIBLE ALUMINUM TUBES MANUFACTURED IN CHESTER, PA, CARROLTON, KY AND VEGA ALTA, PR LOBELINE SULFATE MANUFACTURED IN INGELHEIM, GERMANY. ALUMINUM TUBES, CAPS AND AEROSOL CANS MANUFACTURED IN SCHESSLITZ, GERMANY. STAPAK (TM) FP MANUFACTURED IN DUBLIN, IRELAND. HEPARIN SODIUM DRUG SUBSTANCE MANUFACTURED IN LITTLE ISLAND, CORK, IRELAND BY WEXPORT LTD. BROMFENAC SODIUM SESQUIHYDRATE MANUFACTURED IN CONSHOHOCKEN, PENNSYLVANIA. ETHINYL ESTRADIOL TRANSDERMAL DELIVERY SYSTEM MANUFACTURED IN REDWOOD CITY, CALIFORNIA. FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN MEXICO CITY, DF MEXICO. PYRIDOSTIGMINE BROMIDE MANUFACTURED IN LINZ, AUSTRIA. MAIN ASSEMBLY TURBUHALER MANUFACTURED IN LEHMO, FINLAND. FACILITY AND OPERATING PROCEDURES IN EATONTOWN, NEW JERSEY TINZAPARIN SODIUM DRUG SUBSTANCE MANUFACTURED IN BALLERUP, DENMARK INNOHEP INJECTION 20,000 ANTI-XA IR/ML MANUFACTURED IN BALLERUP, DENMARK SN-1, 2-DIPALMITOY1-3-PHOSPHATIDYLCHOLINE (DPPC) MANUFACTURED IN SUFFOLK, ENGLAND TROMETHAMINE (TRIS AMINO) MANUFACTURED IN IBBENBUREN, GERMANY MEBENDAZOLE POLYMORPH B DRUG SUBSTANCE MANUFACTURED IN GEEL, BELGIUM EX-CELL 400 MANUFACTURED IN DENVER, PENNSLYVANIA 7-AMINO-3-CHLORO-3-CEPHEM-4-CARBOXYLIC ACID, 4-NITROBENZYL ESTER HC1 MANUFACTURED IN AGRATE BRIANZA (MI), ITALY FACILITIES AND PROCEDURES IN DENMARK Page

300

4Q2012EXCEL DMF# 10604 10605 I 10606 I 10607 10608 10609 10610 10611 A 10612 10613 10614 I 10615 I 10616 I 10617 10618 10619 10620 10621 A 10622 10623 A 10624 I 10625 I 10626 I 10627 10628 I 10629 A 10630 10631 10632 I I A III III I 12/2/1993 12/13/1993 12/22/1993 FERRO CORP WHINK PRODUCTS CO HAMNMI FINE CHEMICAL CO LTD IV 12/21/1993 NOF CORP I I III 10/20/1993 12/21/1993 APPRYL AMPACET CORP I 12/15/1993 MING TAI CHEMICAL CO LTD I 12/15/1993 LTS LOHMANN THERAPIE SYSTEME GMBH IV 12/17/1993 I V II 12/17/1993 12/18/1993 PHARMACO LSR JOHNSON MATTHEY PHARMACEUTICAL MATERIALS WARNER JENKINSON CO I I I I II I I II II 10/8/1993 12/15/1993 12/15/1993 12/15/1993 12/15/1993 TANABE SEIYAKU CO LTD FUJI PHOTO FILM CO LTD MAX GB LTD FUJI PHOTO FILM CO LTD CAYMAN PHARMA SRO II 12/9/1993 3M PHARMACEUTICALS I 12/9/1993 HIKMACHEM BPC I I II II I 12/6/1993 12/10/1993 12/6/1993 SIPSY PENINSULA LABORATORIES INC ASAHI CHEMICAL INDUSTRY CO LTD I I I I I II II II IV 12/9/1993 12/8/1993 12/8/1993 12/8/1993 12/6/1993 OWENS ILLINOIS INC BIO-RAD LABORATORIES, INC. BIO-RAD LABORATORIES, INC. BIO RAD LABORATORIES INC ASAHI KASEI CHEMICALS CORP FACILITY AND PROCEDURES IN FINDLAY, OHIO III 11/30/1993 BASF AKTIENGESELLSCHAFT STATUS Type SUBMIT DATE I I IV 12/13/1993 12/9/1993 HOLDER NOVOCOL PHARMACEUTICAL CANADA INC ALEX FRIES SUBJECT FACILITY AND PROCEDURES IN CAMBRIDGE, ONTARIO

4Q2012

NATURAL LEMON-LIME FLAVOR WONF 79-337 SD POWDER MANUFACTURED IN CINCINNATI, OHIO TERLUX KR 2812 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

BIO-GEL DNA HTP (HYDROXYLAPAITE) MANUFACTURED IN RICHMOND, CALIFORNIA MACRO-PREP DEAE SUPPORT MANUFACTURED IN RICHMOND, CALIFORNIA MACRO-PREP T-BUTYL HIC SUPPORT MANUFACTURED IN RICHMOND, CALIFORNIA MICROCRYSTALLINE CELLULOSE SPHERES, CELPHERE MANUFACTURED IN NOBEOKA CITY, JAPAN FEDOTOZINE TARTRATE MANUFACTURED IN AVRILLE CEDEX, FRANCE GLUCAGON-LIKE PEPTIDE 1 (7-36), MANUFACTURED IN BELMONT, CALIFORNIA MANUFACTURING SITE, FACILITIES, PROCEDURES AND PERSONNEL IN NOBEOKA CITY, JAPAN MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN AMMAN, JORDAN PIRBUTEROL ACETATE MANUFACTURED IN GROTON, CONNECTICUT AND KENT, ENGLAND L-ALANINE MANUFACTURED IN OSAKA, JAPAN MANUFACTURING FACILITY IN ODAWARA CITY, JAPAN MANUFACTURING FACILITIES IN TOANSA, INDIA FJ-776 MANUFACTURED IN ODAWARA CITY, JAPAN PROSTAGLANDIN E2 (DINOPROSTONE) MANUFACTURED IN NERATOVICE, CZECH REPUBLIC HPLC ANALYSIS OF GLIPIZIDE IN HUMAN PLASMA IN RICHMOND, VIRGINIA JM-216 MANUFACTURED IN WEST DEPTFORD, NEW JERSEY NO. 62060 SYNTHETIC RED IRON OXIDE, NO. 82150 SYNTHETIC BLACK IRON OXIDE AND NO. 35070 SYNTHETIC YELLOW IRON OXIDE MANUFACTURED IN ST. LOUIS, MISSOURI MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES, AND PERSONNEL IN ANDERNACH, GERMANY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TAOYUAN HSIEN, TAIWAN REPUBLIC OF CHINA. MANUFACTURING FACILITY LOCATED IN LAVERA 11495-S POLYETHYLENE MASTERBACH MANUFACTURED IN TERRE HAUTE, INDIANA, DERIDDER, LOUISIANA AND BY AMPACET EUROPE S.A. IN MESSANCY, BELGIUM 1,2-DIMYRISTOL-SN-GLYCEROL AMMONIUM/SODIUM SALT MANUFACTURED IN HYOGO, JAPAN THERMOPLASTIC COMPOUNDS (NEVOONSO1NA), MANUFACTURED IN EVANSVILLE, IN HDPE PLASTIC BOTTLES AS MFG IN ELDORA,IOWA BULK PHARMACEUTICAL CHEMICAL FACILITY AND QUALITY CONTROL LABORATORIES IN SOUTH KOREA

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4Q2012EXCEL DMF# 10633 10634 I 10635 10636 10637 10638 10639 A 10640 A 10641 10642 10643 10644 10645 10646 I 10647 I 10648 10649 10650 I 10651 I 10652 I 10653 I 10654 10655 10656 A 10657 10658 10659 10660 10661 10662 10663 10664 10665 I I I I I I I I I III II III II I III II II I 12/23/1993 1/6/1994 2/14/1994 1/6/1994 1/5/1994 12/1/1993 12/1/1993 1/5/1994 12/6/1993 BASF AKTIENGESELLSCHAFT SIGMA F AND D DIV LTD DSM POLYMERS CELOX CORP GLAXO WELLCOME INC LOPAREX BV SEPRACOR INC PFIZER IRELAND PHARMACEUTICALS PHARMACIE CENTRALE DE FRANCE I I II II II 12/28/1993 12/6/1993 1/7/1994 KATAYAMA SEIYAKUSYO CO LTD PHARMACIE CENTRALE DE FRANCE SIGMA ALDRICH MANUFACTURING LLC I 12/28/1993 KATAYAMA SEIYAKUSYO CO LTD II 1/10/1994 GADOR SA II 12/9/1993 CYGNUS INC I I II I I 12/20/1993 12/30/1993 12/10/1993 LONZA INC PHARMA TEK INC RELIABLE BIOPHARMACEUTICAL CORP II 10/28/1993 ADHESIVES RESEARCH INC A A I I I II II II II II III 12/16/1993 12/30/1993 12/30/1993 12/28/1993 1/3/1993 12/20/1993 PHARMAZELL GMBH CIPLA LTD EURAND AMERICA INC ELF ATOCHEM NORTH AMERICA INC PLIVA PUREPLAST INC III 12/1/1993 CLARIANT CORP I A I A II III I II II 12/17/1993 12/20/1993 12/13/1993 12/13/1993 12/28/1993 JANSSEN PHARMACEUTICA NV INTRAPAC SEAL LINE SPA BRACCO IMAGING SPA RANBAXY LABORATORIES LTD STATUS Type SUBMIT DATE I II I 11/9/1993 12/15/1993 HOLDER PVP SOCIEDADE ANONIMA PHARMACIA AND UPJOHN INC SUBJECT QUERCETIN MANUFACTURED IN PARNAIBA, BRAZIL

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNLE, AND GENERAL OPERATING PROCEDURES OF NICOTINE CONTAINING PRODUCTS IN HELSINGBORG, SWEDEN. ETOMIDATE MANUFACTURED IN GEEL, BELGIUM COLLAPSIBLE TIN TUBES MANUFACTURED IN CHESTER, PENNSYLVANIA MANUFACTURING PLANT IN MONTEGALDELLA (VI) ITALY IOPAMIDOL MANUFACTURED IN CERIANO LAGHETTO, ITALY 7-AMINO-3-DESACETOXY CEPHALOSPORANIC ACID DRUG SUBSTANCE INTERMEDIATE MANUFACTURED IN ROPAR, PUNJAB, INDIA PACKAGING MATERIALS MANUFACTURED IN HOLDEN, MA; ALBION, MI; MINNEAPOLIS, MN; LAWRENCEVILLE, GA PROPAFENONE HYDROCHLORIDE MANUFACTURED IN RAUBLING, GERMANY ETOPOSIDE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA CAFFEINE MICROCAPS MANUFACTURED IN VANDALIA, OHIO PERFLUORODECYL BROMIDE C10F21BR MANUFACTURED IN PIERRE-BENITE, FRANCE MESALAZINE MANUFACTURED IN SAVSKI MAROF, CROATIA RIGID POLY VINYL CHLORIDE FILM MANUFACTURED IN CAMBRIDGE, ONTARIO, CANADA PRESSURE SENSITIVE ADHESIVES USED AS DRUG MATRIXES MANUFACTURED IN GLEN ROCK, PENNSYLVANIA TRIPROLIDINE HYDROCHLORIDE MANUFACTURED IN LOS ANGELES, CA MANUFACTURING FACILITIES IN ELMIRA, NEW YORK FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN SAINT LOUIS, MISSOURI ESTRADIOL TRANSDERMAL DELIVERY SYSTEM (E2 III TDS) MANUFACTURED IN REDWOOD CITY, CALIFORNIA ZOLPIDEM HEMITARTRATE MANUFACTURED IN PROVINCIA DE BUENOS AIRES, ARGENTINA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN OSAKA, JAPAN. GLYCL-L-GLUTAMINE MANUFACTURED IN OSAKA, JAPAN BISMUTH CITRATE MANUFACTURED IN LA VOULTE SUR RHONE, FRANCE GLYCYLGLYCINE (PRODUCT NO. W 5310-8) MANUFACTURED IN SAINT LOUIS, MISSOURI RAKUSOL BLUE 68-5647 MANUFACTURED IN THE FEDERAL REPUBLIC OF GERMANY COLLAGEN(PRODUCT NO. C 9301) MANUFACTURED IN SAINT LOUIS, MISSOURI STAMYLAN HD 9630 MANUFACTURED IN BEEK, THE NETHERLANDS SERUM-FREE CELL GROWTH MEDIUM MANUFACTURED IN HOPKINS, MINNESOTA MANUFACTURING FACILITY AT VERONA, ITALY. GELROFLEX ALU-PET 100 M - 25 MANUFACTURED IN APELDOORN, THE NETHERLANDS HYPER - D ION EXCHANGERS MANUFACTURED IN VILLENEUVE LA GARENNE, FRANCE FEDOTOZINE TARTRATE MANUFACTURED IN CO. CORK, IRELAND MANUFACTURING FACILITY FOR BISMUTH CITRATE AT LA VOULTE SUR RHONE

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4Q2012EXCEL DMF# 10666 A 10667 10668 I 10669 10670 10671 10672 10673 I 10674 I 10675 I 10676 I 10677 I 10678 I 10679 I 10680 I 10681 I 10682 I 10683 10684 I 10685 10686 10687 I 10688 10689 10690 10691 10692 I 10693 10694 I I I III 1/25/1994 1/7/1994 A I A A II III II II I 1/24/1994 1/20/1994 1/25/1994 1/24/1994 1/17/1994 A A II III II 1/12/1994 1/21/1994 1/17/1994 FIDIA FARMACEUTICI SPA PERLEN CONVERTING AG CHINA SUZHOU NO 5 PHARMACEUTICAL FACTORY MAPRIMED SA COVALENCE COATED PRODUCTS PCAS NV ORGANON CHINA SUZHOU NO 5 PHARMACEUTICAL FACTORY KONICA CHEMICAL CORP ROBB CONTAINER I III III 1/19/1994 1/19/1994 II 12/15/1993 II 12/15/1993 II 12/15/1993 II 12/15/1993 II 12/15/1993 II 12/15/1993 II 12/15/1993 II 12/15/1993 II 12/15/1993 I I A I III III II II I 1/6/1994 1/10/1994 1/10/1994 12/22/1993 12/15/1993 ECP ENICHEM POLYMERES FRANCE COIM USA INC EXCELLA GMBH SCHERING AG CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD WINPAK TECHNOLOGIES INC WINPAK TECHNOLOGIES INC A II III 1/12/1994 1/4/1994 LOBA FEINCHEMIE AG HELVOET PHARMA MARYLAND STATUS Type SUBMIT DATE III 1/18/1994 HOLDER MEDISIZE SCHWEIZ AG SUBJECT

4Q2012

RAW MATERIALS AND MANUFACTURING CONTROLS UTILIZED IN PRODUCTION OF PLASTIC BOTTLES IN NUERENSDORF, SWITERLAND NAPHAZOLINE HYDROCHLORIDE MFG IN FISCHAMEND, AUSTRIA SIL FREE COATED STOPPERS FOR DRUG PACKAGING MANUFACTURED IN SALISBURY MD RIBLENE MP30 MANUFACTURED IN DUNKIRK, FRANCE. NOVACOTE ADH260-805 MANUFACTURED IN HAMBURG, GERMANY ACICLOVIR (ESUB) MANUFACTURED IN FEUCHT, GERMANY ONAPRISTONE MANUFACTURED IN THE BERLIN WEDDING PLANT. FACILITY AND PROCEDURES IN SOFIA, BULGARIA FENOFIBRATE MANUFACTURED IN SOFIA, BULGARIA. PROPANOLOL HYDROCHLORIDE MANUFACTURED IN SOFIA, BULGARIA. KETOTIFEN HYDROGEN MANUFACTURED IN SOFIA, BULGARIA. FLUNARIZINE HYDROCHLORIDE MANUFACTURED IN SOFIA, BULGARIA. PRAZOSIN HYDROCHLORIDE MANUFACTURED IN SOFIA, BULGARIA. BROMOCRIPTINE MESYLATE MANUFACTURED IN SOFIA, BULGARIA. AMIKACIN SULFATE MANUFACTURED IN SOFIA, BULGARIA. TAMOXIFEN CITRATE MANUFACTURED IN SOFIA, BULGARIA. RANITIDINE HYDROCHLORIDE MANUFACTURED IN SOFIA AND DUPNITZA, BULGARIA. POUCH FOR POWDERED DRUGS MANUFACTURED IN TORONTO, ONTARIO, CANADA. NON FORMING LIDDING FOR PILL PACKAGE MANUFACTURED IN TORONTO, ONTARIO, CANADA. ACYCLOVIR MANUFACTURED IN MULAZZANO (MI), ITALY PERLALUX BLISTER FILMS, TWO AND THREE LAYER. METHACYCLINE HYDROCHLORIDE MANUFACTURED IN SUZHOU, JIANGSU. FLECAINIDE ACETATE MANUFACTURED IN BUENOS AIRES, ARGENTINA. PRODUCT 41727-34 MANUFACTURED IN COLUMBUS, GEORGIA. TIMOLOL HEMIHYDRATE MANUFACTURED IN TURKU, FINLAND DEHYDROISOANDROSTERONE MANUFACTURED IN OSS, THE NETHERLANDS. MANUFACTURING FACILITIES GENERAL OPERATING PROCEDURES IN JIANGSU, PEOPLES REPUBLIC OF CHINA. FACILITIES AND PROCEDURES IN SHIZUOKA, JAPAN PHARMACEUTICAL CONTAINERS MANUFACTURED IN PERU, ILLINOIS, OMAHA, NEBRASKA, AND LE CENTER, MINNESOTA

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4Q2012EXCEL DMF# 10695 I 10696 10697 10698 10699 10700 10701 10702 I 10703 I 10704 10705 10706 10707 10708 10709 10710 I 10711 I 10712 10713 10714 I 10715 10716 10717 10718 10719 I 10720 10721 10722 10723 10724 10725 10726 10727 10728 I I A A I I A A A I III III I IV II III II III 2/7/1994 1/28/1994 1/31/1994 1/25/1994 2/2/1994 2/18/1994 2/7/1994 2/4/1994 2/2/1994 I I I I I I II III I 2/2/1994 2/2/1994 2/7/1994 2/14/1994 1/20/1994 ICI AMERICAS INC ICI LTD ESTEVE QUIMICA SA DSM POLYMERS SHANDONG XIN-HUA PHARMACEUTICAL COMPANY LTD CHEMINOR DRUGS PVT LTD CHEVRON PHILLIPS CHEMICAL CO LP GRUPPO MOSSI AND GHISOLFI KONICA CHEMICAL CORP ICI KLEA JANSSEN PHARMACEUTICA NV REXAM HEALTHCARE OFFRANVILLE SAS LUSOCHIMICA SPA ALCO CHEMICAL DIV NATIONAL STARCH AND CHEMICAL CO I A I II IV 2/4/1994 2/4/1994 2/2/1994 CHENG FONG CHEMICALS CO LTD FARCHEMIA SRL ICI KLEA I 2/1/1994 ORGAMOL FRANCE SA A A I I I I II II II II II II II 2/7/1994 2/8/1994 1/28/1994 2/1/1994 2/7/1994 2/2/1994 2/7/1994 JANSSEN PHARMACEUTICA NV JANSSEN PHARMACEUTICA NV IROTEC LABORATORIES HYCLONE LABORATORIES KINERTON LTD IPCA LABORATORIES LTD CIPLA LTD II 1/31/1994 SCHERING AG I I I I I I II III III III III III II 1/25/1994 1/28/1994 1/28/1994 1/18/1994 1/24/1994 1/24/1994 1/25/1994 STATUS Type SUBMIT DATE II 12/15/1993 HOLDER CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD GENSIA LABORATORIES LTD SABIC PETROCHEMICALS BV DSM POLYMERS C AND J INDUSTRIES INC POLYCOM HUNTSMAN INC SPARTECH POLYCOM MITSUBISHI CORP SUBJECT PIROXICAM MANUFACTURED IN SOFIA, BULGARIA. STERILE WATER FOR INJECTION MANUFACTURED IN IRVINE, CA SABIC HDPE MI00053 MANUFACTURED IN BEEK, THE NETHERLANDS. STAMYLAN HD 7625 MANUFACTURED IN BEEK, THE NETHERLANDS. PLASTIC OCUMETER TIPS MANUFACTURED IN MEADVILLE, PA

4Q2012

D55006 WHITE POLYETHYLENE CONCENTRATE MANUFACTURED IN DONORA, PA D23980 WHITE POLYETHYLENE CONCENTRATE MANUFACTURED IN DONORA, PA. NICARDIPINE HYDROCHLORIDE MANUFACTURED BY DAITO CORPORATION IN TOYAMA, JAPAN ELTANOLONE MANUFACTURED IN BERLIN AND CHARLOTTENBURG, FEDERAL REPUBLIC OF GERMANY INTERMEDIATE T001333 MANUFACTURED IN GEEL, BELGIUM INTERMEDIATE T001330 MANUFACTURED IN GEEL, BELGIUM DOBUTAMINE HYDROCHLORIDE MANUFACTURED IN LITTLE ISLAND, CORK, IRELAND HYQ-CCM 1 WITH AND WITHOUT PHENOL RED MANUFACTURED IN LOGAN, UTAH TETRAPEPTIDE (BIM 32001) MANUFACTURED IN DUBLIN, IRELAND FLUMEQUINE MANUFACTURED IN RATLAM, PIN, INDIA ACYCLOVIR MANUFACTURED IN BANGALORE, BOMBAY AND VIKHROLI AND PATALGANGA, INDIA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ST. VULBAS, FRANCE. FACILITY AND OPERATING PROCEDURES IN TAO YUAN HSIEN, TAIWAN, R.O.C. CLOTRIMAZOLE MANUFACTURED IN TREVIGLIO, ITALY 1,1,1,2-TETRAFLUOROETHANE MANUFACTURED IN RUNCORN, CHESHIRE, UNITED KINGDOM FACILITY AND PROCEDURES IN ST. GABRIEL, LOUISIANA FACILITY AND OPERATING PROCEDURES IN RUNCORN, CHESHIRE, UNITED KINGDOM LESOPITRON DIHYDROCHLORIDE MANUFACTURED IN BARCELONA, SPAIN STAMYLEX 1016LF MANUFACTURED IN BEEK, THE NETHERLANDS FACILITY AND PROCEDURES IN ZIBO, SHANDONG, THE PEOPLE'S REPUBLIC OF CHINA. FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN ANDHRA PRADESH, INDIA POLYETHYLENE COPOLYMER RESIN 6109 MANUFACTURED IN ORANGE, TEXAS POLYESTER RESINS MANUFACTURED IN APPLE GROVE, WEST VIRGINIA FACILITIES AND PROCEDURES IN FUKUSHIMA, JAPAN 1,1,1,2-TETRAFLUORETHANE MANUFACTURED IN ST. GABRIEL, LOUISIANA ITRACONAZOLE DRUG SUBSTANCE MANUFACTURED IN GEEL, BELGIUM EYE-DROPPER 5 AND 11 ML, PLUG, CAPS MANUFACTURED IN TAMPERE, FINLAND BETAXOLOL HYDROCHLORIDE MANUFACTURED IN LOMAGNA, ITALY ALCOGUM 926 W MANUFACTURED IN CHATTANOOGA, TENNESSEE

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4Q2012EXCEL DMF# 10729 A 10730 A 10731 10732 I 10733 10734 I 10735 I 10736 10737 I 10738 I 10739 10740 10741 10742 10743 10744 10745 10746 10747 10748 10749 10750 10751 10752 10753 10754 10755 10756 I 10757 10758 10759 I 10760 I II 3/3/1994 AKZO NOBEL CHEMICALS BV I I I II II 2/21/1994 3/8/1994 3/3/1994 NESTE CHEMICALS PEPTISYNTHA AKZO NOBEL CHEMICALS BV FACILITY AND MANUFACTURING PROCEDURES IN PORVOO, FINLAND LY297141 MANUFACTURED IN BRUSSELS, BELGIUM C I I I I A I I I I I I A I I I I II II II I III III III III I II II II II II II II IV II 2/1/1994 2/23/1994 2/28/1994 2/25/1994 2/25/1994 10/18/1993 2/8/1994 2/21/1994 2/25/1994 3/3/1994 3/1/1994 1/25/1994 3/4/1994 3/4/1994 3/4/1994 3/4/1994 2/18/1994 2/28/1994 NICOBRAND LTD DELMAR CHEMICALS INC NIPPON RIKAGAKUYAKUHIN CO LTD FERRING AB BILCARE INC TEKNOR APEX CO EDISON PLASTICS CO NESTE CHEMICALS ARZNEIMITTELWERK DRESDEN GMBH SOLVAY DUPHAR BV SUMIKA FINE CHEMICALS CO LTD BACHEM INC JANSSEN PHARMACEUTICA NV JANSSEN PHARMACEUTICA NV JANSSEN PHARMACEUTICA NV JANSSEN PHARMACEUTICA NV TIMERX TECHNOLOGIES RAYLO CHEMICALS II 2/25/1994 EASTMAN CHEMICAL CO I II I 2/18/1994 2/24/1994 SOCIETA ITALIANA MEDICINAL SCANDICCI CENTRAL GLASS CO LTD I 2/9/1994 PLASTINVENT I KARLSKOGA AB A V I 2/15/1994 2/17/1994 ISOTRON FRANCE SA SAMCHULLY PHARMACEUTICAL CO LTD A II I 11/1/1993 11/29/1993 II 1/20/1994 SHANDONG XINHUA PHARMACEUTICAL CO LTD OLON SPA ALLERGAN INC STATUS Type SUBMIT DATE V 2/23/1994 HOLDER GLAXOSMITHKLINE LLC SUBJECT

4Q2012

PHARMACOLOGY AND TOXICOLOGY INFORMATION REGARDING PROPELLANT HFA-134A (GR106642X) ACETYLSALICYLIC ACID MANUFACTURED IN ZIBO, SHANDONG, THE PEOPLE'S REPUBLIC OF CHINA CEFAZOLIN ACID MANUFACTURED IN MILAN, ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PUERTO RICO. STERILE PROCESSING FACILITY LOCATED IN MARSEILES, FRANCE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KYONGGI-DO, SOUTH KOREA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KARLSKOGA, SWEDEN. CROMOLYN SODIUM MANUFACTURED IN FILARONE, REGGELLO, ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN UBE-CITY, JAPAN. [5-METHYL-2-[(2-NITROPHENYL)AMINO]-3-THIOPHENECARBONITRILE](COMMONLY KNOWN AS TCN, STEP 2) MANUFACTURED IN BATESVILLE, ARKANSAS NICOTINE POLACRILEX RESIN MANUFACTURED IN COLERAINE, N. IRELAND KETOROLAC TROMETHAMINE MANUFACTURED IN LASALLE, QUEBEC, CANADA CYSTEINE HYDROCHLORIDE MANUFACTURED IN ASHIKAGA, JAPAN FACILITY AND OPERATING PROCEDURES IN MALMO, SWEDEN PACKAGING SERVICES IN PHOENIXVILLE, PENNSYLVANIA MONPRENE MP-2840E MANUFACTURED IN ST. ALBANS, VERMONT PACKAGING MATERIALS MANUFACTURED IN NEWPORT NEWS, VIRGINIA POLYETHYLENE PRODUCT NCPE2224 MANUFACTURED IN FINLAND FACILITY AND OPERATING PROCEDURES IN RADEBEUL, GERMANY CHOLECALCIFEROL (VITAMIN D3) MANUFACTURED IN WEESP, THE NETHERLANDS 5MACA (INTERMEDIATE) MANUFACTURED IN THE OKAYAMA PLANT, JAPAN PEPTIDE AL-204 MANUFACTURED IN TORRANCE, CALIFORNIA INTERMEDIATE T000034 MANUFACTURED IN GEEL, BELGIUM INTERMEDIATE T000015 MANUFACTURED IN GEEL, BELGIUM INTERMEDIATE T000506 MANUFACTURED IN GEEL, BELGIUM INTERMEDIATE T000509 MANUFACTURED IN GEEL, BELGIUM CONTROLLED RELEASE EXCIPIENT MANUFACTURED IN DANBURY, CONNETICUT INTERMEDIATE FOR ACA-147, 4-(2,2-DIMETHYLPROPYL)-N-HEXYLBENZENEMETHANAMINE HYDROCHLORIDE MANUFACTURED IN EDMONTON, ALBERTA, CANADA

DISSOLVINE E-CA-10 (EDETATE CALCIUM DISODIUM USP) MANUFACTURED IN HERKENBOSCH, THE NETHERLANDS DISSOLVINE NA-2-P (EDETATE DISODIUM USP) MANUFACTURED IN HERKENBOSCH, THE NETHERLANDS

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4Q2012EXCEL DMF# 10761 I 10762 10763 10764 10765 10766 10767 A 10768 10769 10770 10771 10772 A 10773 10774 10775 I 10776 10777 10778 I 10779 10780 10781 10782 I 10783 I 10784 10785 10786 10787 10788 10789 10790 10791 10792 10793 10794 A 10795 I III 1/31/1994 CODING PRODUCTS CDF-4P HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN A A A I I I I I I I III III III III III III III III III III III 1/31/1994 1/31/1994 1/31/1994 1/31/1994 1/31/1994 1/31/1994 1/31/1994 1/31/1994 1/31/1994 1/31/1994 1/31/1994 CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS III 1/31/1994 CODING PRODUCTS A A A III III III III 1/31/1994 1/31/1994 1/31/1994 1/31/1994 CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS A I III III III 1/31/1994 1/31/1994 1/31/1994 CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS I A III III III 3/1/1994 1/31/1994 1/31/1994 GERRESHEIMER GLAS AG CODING PRODUCTS CODING PRODUCTS I I I I I II II I IV 2/18/1994 3/14/1994 3/11/1994 3/10/1994 3/10/1994 IPCA LABORATORIES LTD FUJISAWA PHARMACEUTICAL CO LTD NIPPON PROTEIN CO LTD CERESTAR, USA, INC. WACKER CHEMICAL CORP A I I I A II II III II III III 2/28/1994 2/28/1994 2/15/1994 3/10/1994 3/8/1994 3/7/1994 COPPERHEAD INVESTMENTS INC SYNTHELABO RECHERCHE BASF AKTIENGESELLSCHAFT SELOC FRANCE GERRESHEIMER BUNDE GMBH RESCO COLOURS INC STATUS Type SUBMIT DATE IV 3/4/1994 HOLDER LIPOID GMBH SUBJECT

4Q2012

LIPOID S 75-MIGLYOL MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY SDM-78 MFG. IN TAMAQUA, PA ELIPRODIL HYDROCHLORIDE MANUFACTURED IN GARGENVILLE, FRANCE NOVOLEN 2600 PCX MANUFACTURED IN WESSELING, GERMANY FLUNIXIN MEGLUMINE MANUFACTURED IN SHANNON, IRELAND AND LEMAY, FRANCE DISPOSABLE SYRINGE SYSTEM MANUFACTURED IN BUNDE, GERMANY 01EHD-225 MANUFACTURED IN MISSISSAUGA, ONTARIO, CANADA AND COVENTRY, RHODE ISLAND IBD-IV MANUFACTURING FACILITY IN RATLAM, INDIA RHIZOXIN MANUFACTURED IN AICHI-PREFECTURE, JAPAN. N-ACETYL-D-GLUCOSAMINE MANUFACTURED IN TOCHIGI-KEN, JAPAN FACILITIES AND OPERATING PROCEDURES IN WAUKEGAN, ILLINOIS HYDROXYPROPYL BETA CYCLODEXTRIN (HPBCD) MANUFACTURED IN WAUKEGAN, ILLINOIS. KIMBLE ITALIANA KI101 GLASS, KI201 GLASS MANUFACTURED IN PISA, ITALY. SV-19811 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN TTR-5903 AND TTR-7903 THERMAL TRANSFER INK RIBBONS MANUFACTURED IN KALKASKA, MICHIGAN SV-19154 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN SV-16391 HOT STAMP INK RIBBONS MANUFACTURED IN KALKASKA, MICHIGAN DOI-1A AND DOI-1A 3/4 HOT STAMP INK RIBBONS MANUFACTURED IN KALKASKA, MICHIGAN DOI-6 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN SV-16810 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN SV-17805 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN TTR-5907, TTR-5908, TTR-7907 AND TTR-7908 THERMAL TRANSFER IN RIBBONS MANUFACTURED IN KALKASKA, MICHIGAN TTR-5901, TTR-5902, TTR-7901 AND TTR-7902 THERMAL TRANSFER INK RIBBONS MANUFACTURED IN KALKASKA, MICHIGAN SV-16356 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN SV-14808 HOT STAMP INK RIBBON MANUFACTRUED IN KALKASKA, MICHIGAN SV-13807 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN TTR-7909 THERMAL TRANSFER INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN DOI-6A HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN DOI-9 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN DS-1 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN FOI-3 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN FOI-4 HOT STAMP INK KRIBBON MANUFACTURED IN KALKASKA, MICHIGAN TTR-5900 THERMAL TRANSFER INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN CDF-1 AND CDF-1 3/4 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

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4Q2012EXCEL DMF# 10796 10797 A 10798 10799 10800 10801 10802 10803 10804 A 10805 10806 10807 10808 10809 10810 10811 10812 A 10813 10814 10815 I 10816 10817 I 10818 10819 I 10820 10821 I 10822 10823 A 10824 A 10825 10826 I 10827 10828 I I III I 3/23/1994 3/24/1994 LABORATORIOS DR ESTEVE SA JANSSEN PHARMACEUTICA NV I II III 3/25/1994 3/1/1994 III 3/20/1994 POLYONE CORP GLS THERMOPLASTIC ELASTOMERS JICHENG PHARMACEUTICAL FACTORY GERRESHEIMER GLAS AG I I II 3/18/1994 3/18/1994 I I I 3/17/1994 4/12/1994 I II III 3/18/1994 3/10/1994 CHEMOX CHEMICAL INDUSTRIES LTD MORGAN ADHESIVES CO ROLL PRODUCTS DIV BIOVAIL CORP INTERNATIONAL I III II 3/9/1994 3/15/1994 PACUR INC BACHEM FEINCHEMIKALIEN AG I I II II III 3/15/1994 3/16/1994 3/16/1994 JANSSEN PHARMACEUTICA NV LABORATOIRES SERONO SA SCHUPBACH AG I I I I I I I III III III III III III III II 1/31/1994 1/31/1994 1/31/1994 1/31/1994 1/31/1994 1/31/1994 1/31/1994 3/15/1994 CODING PRODUCTS CODING PRODUCTS CODING CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS ALBEMARLE CORP CDF-33 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN CDF-96 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN CDF-95 HOT STAMP INK RIBBON MANUFACUTRED IN KALKASKA, MICHIGAN CDF-93 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN CDF-94 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN CDF-92 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN CDF-37 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN I I I A I I III III III III III III III 1/31/1994 1/31/1994 1/31/1994 1/31/1994 1/31/1994 1/31/1994 1/31/1994 CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS CDF-634 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN CDF-63 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN CDF-14 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN CDF-98 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN DB-1 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN DB-14 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN STATUS Type SUBMIT DATE A III III 1/31/1994 1/31/1994 HOLDER CODING PRODUCTS CODING PRODUCTS SUBJECT CDF-6 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

4Q2012

CDF-9 AND CDF-9 3/4 HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MICHIGAN

DOI-1 AND DOI-1 3/4 HOT STAMP INK RIBBONS MANUFACTURED IN KALKASKA, MICHIGAN

MACA (5-METHANESULFONYLAMINOINDOLE-2-CARBOXYLIC ACID) MANUFACTURED IN SOUTH HAVEN, MICHIGAN INTERMEDIATE T000743 MANUFACTURED IN GEEL, BELGIUM STERILE DILUENT (0.3% M-CRESOL) MANUFACTURED IN AUBONNE, SWITZERLAND COMPOUND PACKAGING MATERIAL #SOP 25255 PAPER/PE/ALU/LONOMER MANUFACTURED IN BURGDORF, SWITZERLAND. PETG COPOLYESTER 6763 MATERIAL MANUFACTURED IN OSHKOSH, WISCONSIN 1-HYDROXY-2-NAPHTHOYL-ARG-PRO-NH2 HYDROCHLORIDE MANUFACTURED IN BUBENDORF, SWITZERLAND SULFAMETHOXAZOLE MANUFACTURED IN GUJARA, INDIA. PHARMACEUTICAL LABEL PRODUCT LINE MANUFACTURED IN STOW, OHIO AND NELLIS, NEVADA. MANUFACTURING FACILITIES IN STEINBACH, CANADA.

CHINOIN PHARMACEUTICAL AND CHEMICAL FACILITY FOR THE MANUFACTURE OF SELEGILINE HYDROCHLORIDE IN BUDAPEST, WORKS LTD HUNGARY CHEMOX CHEMICAL INDUSTRIES LTD FACILITIES AND PROCEDURES IN GUJARA, INDIA. DOTTIKON EXCLUSIVE SYNTHESIS AG ISOSORBIDE-5-NITRATE EXTENDED RELEASE PREMIXTURE 49.2% MANUFACTURED IN DOTTIKON, SWITZERLAND. THERMOPLASTIC ELASTOMER COMPOUNDS MANUFACTURED IN CARY, ILLINOIS. MINOXIDIL MANUFACTURED IN SHANGHAI, PEOPLE'S REPUBLIC OF CHINA. KIMBLE N51A GLASS, KIMBLE AMBER 203 GLASS AND KIMBLE KG-33 GLASS MANUFACTURED IN VINELAND, NEW JERSEY. FACILITIES AND PERSONNEL IN MARTORELLAS (BARCELONA), SPAIN. FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN BEERSE, BELGIUM. Page

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4Q2012EXCEL DMF# 10829 10830 10831 10832 10833 10834 10835 10836 10837 10838 A 10839 10840 10841 I 10842 10843 I 10844 I 10845 I 10846 I 10847 I 10848 10849 10850 I 10851 I 10852 I 10853 10854 10855 10856 10857 10858 I 10859 10860 10861 I I I II II II 4/8/1994 4/11/1994 2/28/1994 JANSSEN PHARMACEUTICA NV JANSSEN PHARMACEUTICA NV PVP SOCIEDADE ANONIMA I A I A A II IV I II II II 4/8/1994 4/8/1994 4/7/1994 4/4/1994 4/5/1994 4/11/1994 ASTRAZENECA PHARMACEUTICALS LP CRODA EUROPE LTD SPOLANA NERATOVICE JANSSEN PHARMACEUTICA NV CU CHEMIE UETIKON GMBH CIPLA LTD II 4/7/1994 I 3/29/1994 I I II II I 3/30/1994 4/11/1994 3/31/1994 GANES CHEMICALS INC PIERCE CHEMICAL CO MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC MERCK AND CO INC DIV MERCK SHARP AND DOHME 3M BIOAPPLICATIONS III 3/31/1994 BASF CORPORATION IV 3/15/1994 MOTHER MURPHYS LABORATORIES INC III 3/14/1994 KALLE PENTAPLAST GMBH II 3/25/1994 BACHEM FEINCHEMIKALIEN AG I I I 3/30/1994 3/30/1994 LEO PHARMACEUTICAL PRODUCTS LTD LEO PHARMACEUTICAL PRODUCTS LTD A I II II I 3/30/1994 3/30/1994 3/25/1994 LEO PHARMA AS LEO PHARMACEUTICAL PRODUCTS LTD BACHEM FEINCHEMIKALIEN AG STATUS Type SUBMIT DATE I A C I I I I A A II II II III II I I II II II 3/22/1994 3/24/1994 3/24/1994 3/21/1994 3/25/1994 3/25/1994 3/24/1994 3/30/1994 3/28/1994 3/29/1994 HOLDER DOCTOR REDDYS LABORATORIES LTD YUNG ZIP CHEMICAL IND CO LTD YUNG ZIP CHEMICAL IND CO LTD MILLIKEN AND CO SIANG TA PHARMACEUTICAL CO LTD SANDOZ CANADA INC HANJIANG PHARMACEUTICAL FACTORY KYOWA HAKKO KOGYO CO LTD ERREGIERRE SPA SANDOZ GMBH SUBJECT 2,6-DIISOPROPYLPHENOL MFG. IN ANDHRA PRADESH, INDIA. ACYCLOVIR MANUFACTURED IN TACHIA, TAIWAN, REPUBLIC OF CHINA.

4Q2012

DICLOFENAC POTASSIUM MANUFACTURED IN TACHIA, TAIWAN, REPUBLIC OF CHINA. PC COLORANTS MANUFACTURED IN BLACKSBURG, SOUTH CAROLINA. METHOCARBAMOL MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA. FACILITIES AND PROCEDURES IN WHITBY, ONTARIO, CANADA. FACILITY AND PROCEDURES IN HANZHONG CITY, SHAANXI PROVINCE, CHINA. SODIUM HYALURONATE MANUFACTURED IN UBE-SHI, JAPAN. FLUOXETINE HYDROCHLORIDE MANUFACTURED IN BERGAMO, ITALY. 7-PACA (7-AMINO-3-PROPENYL-CEPHALOSPORANIC ACID) MANUFACTURED IN KUNDL, TYROL, AUSTRIA. CALCIPOTRIENE SCALP SOLUTION MANUFACTURED IN BALLERUP, DENMARK. EB 1089 MANUFACTURED IN BALLERUP, DENMARK. MANUFACTURING FACILITY FOR AC-ARG-PRO-ASP-ISOBUTYLAMIDE CITRATE MANUFACTURED IN BUBENDORF, SWITZERLAND. FACILITY FOR THE MANUFACTURE OF EB 1089 IN BALLERUP, DENMARK. FACILITY FOR THE MANUFACTURE OF CALCIPOTRIENE SCALP SOLUTION IN BALLERUP, DENMARK. AC-ARG-PRO-ASP-ISOBUTYLAMIDE CITRATE MANUFACTURED IN BUBENDORF, SWITZERLAND. HOSTAPET AMORPHOUS POLYESTER FILM MANUFACTURED IN WEERT, THE NETHERLANDS. N & A CINNAMON MINT FLAVOR NO. 6244 MANUFACTURED IN GREENSBORO, NORTH CAROLINA. LAROSTA FPE AND LAROSTA FPE-S, ANTISTAIC AGENTS MANUFACTURED IN GURNEE, ILLINOIS. SPARFOSATE SODIUM MANUFACTURED IN CARLSTADT, NEW JERSEY. EMPHAZE PROTEIN A BIOSUPPORT MEDIUM MANUFACTURED IN ST. PAUL, MINNESOTA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ROUND ROCK, TEXAS. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BOLLATE (MILAN) ITALY. 3M EMPHAZE HYDRAZIDE BIOSUPPORT MEDIUM MANUFACTURED IN ST. PAUL, MINNESOTA. LISINOPRIL BULK DRUG MANUFACTURED IN GUAYAMA, PUERTO RICO. SUPER REFINED SESAME OIL MANUFACTURED IN MILL HILL, PENNSYLVANIA. FACILITIES AND OPERATING PROCEDURES IN NERATOVICE, CZECH REPUBLIC. INTERMEDIATE T000824 MANUFACTURED IN BEERSE AND GEEL, BELGIUM. AZELAIC ACID MANUFACTURED IN LAHR, GERMANY. MITOXANTRONE HYDROCHLORIDE MANUFACTURED IN BANGALORE, BOMBAY AND MAHARASHTRA, INDIA AZAPERONE MANUFACTURED IN GEEL, BELGIUM MEBENDAZOLE POLYMORH C MANUFACTURED IN GEEL, BELGIUM PILOCARPINE HYDROCHLORIDE MANUFACTTURED IN PARNAIBA, BRAZIL

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4Q2012

FERMENTACIONES Y SINTESIS ESPANOLAS NITRO-THIAZOLINE MANUFACTURED IN COAHUILA, MEXICO SA CURWOOD INC PACKAGING MATERIALS MANUFACTURED IN OSHKOSH AND NEW LONDON, WISCONSIN

POLYETHYLENE FILMS AND BAGS MANUFACTURED IN BURGDORF, SWITZERLAND MONTANIDE ISA 51 VG STERILE EXFENFLURAMINE HYDROCHLORIDE MANUFACTURED IN ST. FRANCIS, WISCONSIN PIMOZIDE MANUFACTURED IN BEERSE AND GEEL, BELGIUM DEXFENFLURAMINE BASE MANUFACTURED IN TOLEDO, SPAIN METHOD VALIDATION NITOGLYCERIN AND ITS DINITROGLYCERIN METABOLITES IN HUMAN PLASMA FACILITIES AND PERSONNEL IN TOLEDO, SPAIN MACRO-PREP 50 EPOXIDE, DISTILLED SIZED SUPPORT PYRIDOSTIGMINE BROMIDE MANUFACTURED IN BIASCA, SWITZERLAND GONADORELIN ACETATE MANUFACTURED IN COPENHAGEN, DENMARK NEOSORB 70/20 SORBITOL SOLUTION MANUFACTURED IN GURNEE, ILLINOIS CASTANOSPERMINE MANUFACTURED IN PEAKHURST, AUSTRALIA PENTAX HIGH CAPACITY CERAMIC HYDROXYAPATITE MANUFACTURED IN TOKYO, JAPAN WHITE CONCENTRATE (01EHD-371) MANUFACTURED IN MISSISSAUGA, ONTARIO, CANADA AND COVENTRY, RHODE ISLAND PANCRELIPASE (ULTRASE) MINITABS MANUFACTURED IN CINISELLO BALSAMO, (MI) ITALY GLYCYL-L-GLUTAMINE HYDRATE MANUFACTURED IN KANAGAWA, JAPAN RANITIDINE HYDROCHLORIDE USP MANUFACTURED IN CELRA (GERONA) SPAIN FOR NOVOPHARM LTD FACILITIES AND PROCEDURES IN LE MANS, FRANCE ALCOGUM 9710 MANUFACTURED IN CHATTANOOGA, TENNESSEE FACILITY AND OPERATING PROCEDURES IN BEUVRY-LA-FORET, FRANCE ASTEMIZOLE MANUFACTURED IN SOUTH HAVEN, MICHIGAN FACILITIES AND OPERATING PROCEDURES IN THE CHEMICAL PILOT PLANT, BEERSE, BELGIUM FOSFOMYCIN TROMETAMOL MANUFACTURED IN VICENZA, ITALY FACILITY AND MANUFACTURING PROCEDURES IN GLOUCESTERSHIRE, UNITED KINGDOM FACILITIES AND OPERATING PROCEDURES IN BRIENNE LE CHATEAU, FRANCE

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4Q2012EXCEL DMF# 10894 I 10895 A 10896 I 10897 I 10898 I 10899 I 10900 10901 10902 10903 10904 10905 I 10906 10907 10908 I 10909 I 10910 10911 10912 10913 10914 A 10915 10916 I 10917 10918 10919 10920 10921 10922 10923 I 10924 I II 5/24/1994 I A A I I I III II II I I II II 5/24/1994 6/8/1994 5/27/1994 5/24/1994 5/31/1994 5/25/1994 5/25/1994 SARNATECH XIRO AG PROCOS SPA NORAMCO INC RHONE POULENC RORER GMBH NICHOLAS PIRAMAL INDIA LTD NORAMCO INC GENZYME CORP A III III 4/29/1994 5/11/1994 ECP ENICHEM POLYMERES FRANCE TICONA LLC I A I A II IV II II II 5/17/1994 5/13/1994 5/20/1994 5/20/1994 4/22/1994 I 5/17/1994 MEDISORB TECHNOLOGIES INTERNATIONAL FACILITY AND OPERATING PROCEDURES IN WILMINGTON, OHIO LTD PARTNERSHIP SUMITOMO CHEMICAL CO LTD SB210272 MANUFACTURED IN ANPACHI-GUN, GIFU PREFECTURE, JAPAN NATIONAL STARCH LLC JANSSEN PHARMACEUTICA NV JANSSEN PHARMACEUTICA NV HOYA CORP PURITY 21 (45-0821) MANUFACTURED IN BRIDGEWATER, NEW JERSEY MICONAZOLE DRUG SUBSTANCE MANUFACTURED IN GEEL, BELGIUM MICONAZOLE NITRATE MANUFACTURED IN GEEL, BELGIUM I I III I I 5/19/1994 5/13/1994 5/17/1994 ZELLER PLASTIK INC KELCO INTERNATIONAL LTD VECTOR CORP EAST COAST LABORATORY I A N I A III III I 4/25/1994 5/11/1994 5/5/1994 II II 5/12/1994 5/18/1994 V 5/11/1994 II 5/13/1994 II 5/10/1994 KNOLL AG I 5/3/1994 RHONE POULENC RORER SA III 5/2/1994 AMPACET CORP STATUS Type SUBMIT DATE III 5/2/1994 HOLDER AMPACET CORP SUBJECT

4Q2012

150206 RED POLYETHYLENE MASTERBACH MANUFACTURED LOUISIANA OR MESSANCY, BELGIUM 170207 GREEN POLYETHYLENE MASTERBACH MANUFACTURED IN TERRE HAUTE, INDIANA, DERIDDER, LOUISIANA OR MESSANCY, BELGIUM FACILITY AND OPERATING PROCEDURES IN VILLENEUVE-LA-GARENNE CEDEX, FRANCE

S-ADENOSYL-L-METHIONINE 1, 4-BUTANEDISULFONATE MANUFACTURED IN SAN ANTONIO, SWITZERLAND INSTITUTE DRUG TECHNOLOGY AUSTRALIA CISPLATIN DRUG SUBSTANCE MANUFACTURED IN BORONIA, VICTORIA, AUSTRALIA LTD JOHNSON MATTHEY INC PHARMACEUTICAL SYRINGE ASEPTIC FILL PROGRAM IN GRAND ISLAND, NEW YORK. MATERIALS GROUP VIALE FULVIO TESTI TIMOLOL MALEATE MANUFACTURED IN FROSININE, ITALY TEVA PHARMACEUTICAL INDUSTRIES LTD NOT AN ASSIGNED NUMBER BASF AKTIENGESELLSCHAFT TICONA LLC RHONE POULENC RORER GMBH NOVOLEN 1040 RC MANUFACTURED IN E-TARRAGONA, SPAIN GUR AND GHR POLYETHYLENES MANUFACTURED IN PASADENA, TEXAS FACILITIES AND OPERATING PROCEDURES FOR THE MANUFACTURE OF 10-DAB IN KOLN, GERMANY PLASTIC PACKAGING COMPONENTS MANUFACTURED IN LIBERTYVILLE, IL MANUFACTURING FACILITY AND PROCEDURES AT KNOWSLEY, UNITED KINGDOM FACILITIES AND OPERATING PROCEDURES IN CRANBURY, NEW JERSEY LABETALOL HYDROCHLORIDE MANUFACTURED IN MILANO, ITALY

PENTAX STANDARD CAPACITY CERAMIC HYDROXYAPATITE MANUFACTURED IN TOKYO, JAPAN FLEXIRENE MS40 MANUFACTURED IN DUNKIRK, FRANCE GUR AND GHR POLYETHYLENES MANUFACTURED IN OBERHAUSEN, FEDERAL REPUBLIC OF GERMANY XIRO ADHESIVE FILM V -300 MANUFACTURED IN SCHMITTEN, SWITZERLAND LABETALOL MANUFACTURED IN CAMERI, ITALY TOPIRAMATE DRUG SUBSTANCE MANUFACTURED IN ATHENS, GEORGIA MANUFACTURING FACILITY A VITRY-SUR-SEINE CEDEX, FRANCE MANUFACTURING FACILITY AT MADHYA PRADESH, INDIA OFLOXACIN MANUFACTURED IN AHENS, GEORGIA

SN-1-PALMITOYL-2-OLEOYLPHOSPHATIDYLGLYCEROL SODIUM SALT (POPG.NA) MANUFACTURED IN SUFFOLK, ENGLAND PROSINTEX INDUSTRIE CHIMICHE ITALIANE PIRENZEPINE DIHYDROCHLORIDE MANUFACTURED IN MILANO, ITALY S.R.L.

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4Q2012

PLASTIBASE 50W (PLASTICIZED HYDROCARBON GEL) MANUFACTURED IN HUMACO, PUERTO RICO AND BUFFALO, NY ULTRAFORM W 2320 003 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY MANUFACTURING PLANT AT NOTO, JAPAN FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES A SAN DIEGO, CA METHYL SULFONAMIDE INDOLE-2- CAROXYLIC ACID MANUFACTURED IN PITHIVIERS, FRANCE STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN CHARLOTTE, NC. STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN CORONA, CA FORALKYL BR 8 NP, C8F17BR MANUFACTURED IN CEDEX, FRANCE MANUFACTURING FACILITIES OPERATING PROCEDURES AND PERSONNEL AT LIMU, PERU LUPOLEN 2420 F MANUFACTURED IN WESSELING, (FEDERAL REPUBLIC OF GERMANY) RUBBER COMPOUND NO. 6460 MANUFACTURED IN HORSENS, DENMARK

MANUFACTURING SITE, OPERATING PROCEDURE AND PERSONNEL A DOSSENHEIM, GERMANY MICROCELLULOSE WEIBENBORN GMBH CO OMNICEL, MICROCRYSTALLINE CELLULOSE USP N.F. MANUFACTURED IN WEIBENBORN, GERMANY AMPACET CORP 100327 UV BARRIER PE MB MANUFACTURED IN TERRE HAUTE, INDIANA; DERIDDER, LOUISIANA; MESSANCY, BELGIUM 3M PHARMACEUTICALS INC CONTAINER-CLOSURE SYSTEM FOR NON-CFC INHALATION AEROSOLS ASSEMBLED IN NORTHRIDGE, CA. & LOUGHBOROUGH, LEICESTERSHIRE, ENGLAND TAIWAN BIOTECH CO LTD 7 - AMINO CEPHALOSPORANIC ACID MANUFACTURED IN TAIWAN, ROC JANSSEN PHARMACEUTICA NV JANSSEN PHARMACEUTICA NV WOCKHARDT LTD INTERMEDIATE T001001 MANUFACTURED IN GEEL, BELGIUM LOPERAMIDE HYDROCHLORIDE MANUFACTURED IN GEEL, BELGIUM FACILITY AND OPERATING PROCEDURES IN CHIKALTHANA, AURANGABAD, MAHARASHTRA STATE INDIA NEDOCROMIL SODIUM MANUFACTURED IN SINGAPORE ACYCLOVIR SODIUM (ESUB) MANUFACTURED IN FEUCHT, GERMANY HALOPERIDOL, MANUFACTURED IN GEEL, BELGIUM INTERMEDIATE T000263, MANUFACTURED IN GEEL, BELGIUM

CHINOIN PHARMACEUTCIAL AND CHEMICAL ALPROSTADIL, MANUFACTURED IN BUDAPEST, HUNGARY WORKS CO LTD SIGMA ALDRICH IRELAND LTD CLOMIPRAMINE HYDROCHLORIDE, MANUFACTURED IN ARKLOW, IRELAND MITSUI CHEMICALS INC HOBA LACKE UND FARBEN GMBHIK UCB TRANSPAC NV DATWYLER PHARMA PACKAGING BELGIUM NV JANSSEN PHARMACEUTICA NV MILLION AND MIPELON RESINS.MANUFACTURED IN YAMAGUGUCHI INDUSTRIES LACQQUERS IL-320-0136 & IL-320-1528, MANUFACTURED IN NUREMBERG, GERMANY RAYOPEEL P AND ITS MEDIFLEX LAMINATES MANUFACTURED IN GENT, BELGIUM RUBBER COMPOUNDS MANUFACTURED IN PENNSAUKEN, NEW JERSEY, ALKEN, BELGIUM AND PREGNANA MILANESE, ITALY HALOPERIDOL DECANOATE, MANUFACTURED IN GEEL, BELGIUM

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4Q2012EXCEL DMF# 10955 I 10956 10957 I 10958 10959 10960 10961 10962 I 10963 10964 A 10965 10966 10967 I 10968 A 10969 10970 I 10971 I 10972 10973 I 10974 I 10975 10976 10977 10978 10979 10980 I 10981 10982 A 10983 I 10984 A III 6/27/1994 I 7/12/1994 A II II 7/8/1994 7/11/1994 TOKYO KASEI KOGYO CO LTD I C I I I III II III II IV I 7/1/1994 7/11/1994 7/8/1994 7/8/1994 7/7/1994 7/1/1994 ISHIDA PRESS KOGYO CO LTD TEVA PHARMACEUTICAL INDUSTRIES LTD ACI BLOWPAK CILAG AG SANDOZ PHARMA LTD ZELLER PLASTIK GMBH I 7/1/1994 I II IV 6/28/1994 7/8/1994 I 6/29/1994 I I II 6/28/1994 6/28/1994 CHIFENG PHARMACEUTICAL FACTORY GUANGDONG PHARMACEUTICAL FACTORY III 6/22/1994 B LAUFENBERG GMBH I I IV II I 8/16/1994 6/24/1994 6/15/1994 ACCESS PHARMACEUTICALS INC TEVA PHARMACEUTICALS INC RAYLO CHEMICALS A II III 6/24/1994 6/15/1994 MILLIPORE CORP AMPACET CORP DURAPORE FILTER MEMBRANE MANUFACTURED IN CORK, IRELAND A A I A IV III IV III II 6/24/1994 6/21/1994 6/24/1994 6/24/1994 6/21/1994 GRAIN PROCESSING CORP BERRY PLASTICS CORP HULS AKTIENGESELLSCHAFT BESPAK DIV CONSORT MEDICAL PLC NORDIC SYNTHESIS AB I II I 6/21/1994 6/24/1994 SANKYO KASEI CO LTD HOECHST CANADA INC STATUS Type SUBMIT DATE I 6/21/1994 HOLDER SANKYO KASEI CO LTD SUBJECT

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURESFOR MANUFACTURE OF OXYBENZONE USP XXII, MANUFACTURED IN HIROSHIMA, JAPAN OXYBENZONE USP XXII, MANUFACTURED IN HIROSHIMA, JAPAN MANUFACTURING SITES, FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN QUEBEC, CANADA PHARMACEUTICAL STARCHES MANUFACTURED IN MUSCATINE, IOWA. 936.1 FILM AS MANUFACTURED IN CHIPPEWA FALLS, WI DEHYDRATED ALCOHOL (ETHANOL) USP MANUFACTURED IN HERNE, GERMANY BK357 PHARMACEUTICAL METERING VALVE, MANUFACTURED IN NORFOLK, ENGLAND TACRINE HYDROCHLORIDE MONOHYDRATE, MANUFACTURED IN KARLSKOGA, SWEDEN

10053 ANTISTA POLYETHYLENE MASTERBACH, MANUFACTURED IN TERRE HAUTE, INDIANA, DERIDDER, LOUISIANA AND BELGIUM SEPA 0009 (2-NONYL-1,3-DIOXACYCLOPENTANE),MFG. IN SCOTLAND ,UK DIHYDRO DANE SALT, MANUFACTURED IN MEXICO, MISSOURI MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN EDMONTON, ALBERTA, CANADA. SILICONE COATING ON ALUMINIZED POLYESTER FILM MANUFACTURED IN HULS, GERMANY MANUFACTURING SITE, FACILITIES AND PERSONNEL AT INNER MONGOLIA, P.R. CHINA MICONAZOLE NITRATE MANUFACTURED IN GUANGZHOU, CHINA

CHINOIN PHARMACEUTICAL AND CHEMICAL FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES AT BUDAPEST, WORKS LTD HUNGARY CATALENT PHARMA SOLUTIONS LLC VESANOID, 10MG SOFTGELS MANUFACTURED IN ST. PETERSBURG, FLORIDA GOLDSCHMIDT CHEMICAL DIV WILSON PHARMA AND CHEMICAL CORP CHEMOSWED AB PEG-25 GLYCERYL TRIOLEATE, (TAGAT TO) MANUFACTURED IN ESSEN, GERMANY MANUFACTURING FACILITIES, PERSONNEL AND GENERAL PROCEDURES AT MALMO, SWEDEN ALUMINIUM CAPS FOR VIALS MANUFACTURED A SAITAMA, JAPAN BUDESONIDE, MFG. IN MILANO, ITALY POLYPROPYLENE VIALS MFG. IN KINGSGROVE, AUSTRALIA TOPIRAMATE, MFG. IN SCHAFFHAUSEN, SWITZERLAND CORN OIL-MONO-DI-TRIGLYCERIDES MFG. IN BASLE, SWITZERLAND. MFG SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL A ZELL/MOSEL, FEDERAL REPUBLIC OF GERMANY TROPICAMIDE USP, MFG. IN SAITAMA, JAPAN

UNION QUIMICO FARMACEUTICA SA UQUIFA CIMETIDINE USP MANUFACTURED IN BARCELONA, SPAIN. SA ACCUCAPS INDUSTRIES LTD MFG. FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES AT WINDSOR, ONTARIO AKCROS CHEMICALS INC INTERSTAB HEAT AND LIGHT STABILIZERS MFG. IN NEW BRUNSWICK, NJ

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4Q2012EXCEL DMF# 10985 A 10986 10987 10988 10989 10990 I 10991 A 10992 10993 10994 10995 10996 10997 10998 10999 11000 I 11001 11002 I 11003 11004 11005 I 11006 11007 I 11008 11009 I 11010 11011 I 11012 I 11013 I 11014 I 11015 I II 8/2/1994 JANSSEN PHARMACEUTICA NV II 7/28/1994 BIOSYNTH AG II 8/2/1994 JRH BIOSCIENCES III 7/27/1994 RESCO COLOURS INC A III I 7/25/1994 7/28/1994 ST GOBAIN DESJONQUERES SA SGD VERDUGT B V A II III 7/26/1994 8/2/1994 I III I 7/29/1994 7/28/1994 REXAM MEDICAL PACKAGING INC BIO PHARMACEUTICAL PHARMACEUTICS SERVICES INC DIV IBAH INC ORGAPHARM PMS CONSOLIDATED I A III II III 7/25/1994 7/21/1994 7/1/1994 DSM POLYMERS PROCOS SPA TOYO ALUMINUM KK A III I 7/26/1994 7/22/1994 NIPRO GLASS GERMANY AG SANDOZ LTD I I A I I I A I II III II II II III II III I 7/14/1994 7/15/1994 7/19/1994 7/21/1994 7/21/1994 7/22/1994 8/25/1994 5/9/1994 7/25/1994 PHOSPHOLIPID GMBH CARCANO ANRONIO S.P.A. FIDIA FARMACEUTICI SPA JANSSEN PHARMACEUTICA NV GENZYME LTD TUBENFABRIK BISCHOFSZELL APOTEX PHARMACHEM INC BASF AKTIENGESELLSCHAFT SANOFI RECHERCHE II 7/14/1994 PHOSPHOLIPID GMBH I I I I II II II II I 7/18/1994 7/18/1994 7/19/1994 7/15/1994 7/20/1994 JANSSEN PHARMACEUTICA NV JANSSEN PHARMACEUTICA NV SIANG TA PHARMACEUTICAL CO LTD HEUMANN PHARMA GMBH AND CO SPIRIG AG STATUS Type SUBMIT DATE III 7/8/1994 HOLDER KARL HOLL GMBH AND CO KG SUBJECT ALUMINIUM AND LAMINATE TUBES MANUFACTURED IN LANGENFELD AND KIRCHHEIMBOLANDEN, FEDERAL REPUBLIC OF GERMANY. INTERMEDIATE T001349, MANUFACTURED IN GEEL, BELGIUM. INTERMEDIATE T000425 MANUFACTURED IN GEEL, BELGIUM.

4Q2012

GUAIFENESIN MANUFACTURED IN HU-KUO HSINCHU, TAIWAN, THE REPUBLIC OF CHINA RANITIDINE HYDROCHLORIDE-FORM 1 MANUFACTURED IN FEUCHT, GERMANY MANUFACTURING FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN EGERKINGEN, SWITZERLAND PHOSPHOLIPON 90 H MANUFACTURED BY CU CHEMIE UETIKON GMBH IN LAHR, GERMANY. PHOSAL 50 PG MANUFACTURED IN COLOGNE, GERMANY. PACKAGING MATERIALS FOR SUPPOSITORIES MFG. IN MANDELLO DEL LARIO, ITALY BUMETANIDE MFG. IN MILAN, ITALY LEVAMISOLE HYDROCHLORIDE CRUDE MFG. IN GEEL, BELGIUM 5-METHYLSULFONAMIDOINDOLE-2-CARBOXYLIC ACID MGF. IN SUFFOLK, ENGLAND ALUMINUM DRUG PACKAGE MATERIALS MFG. IN BISCHOFSZELL, SWITZERLAND RANITIDINE HCL MFG. IN TOLUCA, ESTADO DE MEXICO, MEXICO STYROLUX 637 D MFG. IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TOULOUSE, FRANCE. ARTICLES OF TUBULAR GLASS MFG. IN MUNNERSTADT, GERMANY MANUFACTURING FACILITIES, PERSONENEL, AND GENERAL OPERATING PROCEDURES IN CO. CORK, IRELAND. STAMYLEX 2H 438 MFG. IN AA BEEK, THE NETHERLANDS. EMBUTRAMIDE MFG. IN NOVARA, ITALY FILM PACKAGING MATERIAL: PET, LDPE REVERSE PRINTED WHITE, ALUMINUM FOIL, ADHESIVE AND ACRYLONITRILE FILM MFG. IN GUMA & OSAKA, JAPAN ECDEL LAYFLA FILM MANUFACTURED IN BRISTOL, ENGLAND MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL AT FORT WASHINGTON, PA HEMATOPORPHYRIN DIHYDROCHLORIDE MANUFACTURED IN PITHIVIERS, FRANCE COLORANT-061233CMBR,USED IN PLASTIC PACKAGING MATERIALS MANUFACTURED IN ELK GROVE VILLAGE,ILLINOIS GLASS TYPE II CONTAINERS, MFG. IN MERS-LES BAINS, FRANCE MANUFACTURING FACILITIES OPERATING PROCEDURES AND PERSONNEL IN TIEL, NETHERLAND BLUE WHITE MASTERBACH 01EHD-261 MFG IM MISSISSAUGA, ONTARIO, CANADA AND COVENTRY, RHODE ISLAND RPMI 1640 MEDIUM, W/O L-GLUTAMINE AND W/O PHENOL RED (PROD. NO. 52773), MFG IN WOODLAND, CA MELATONIN AND A STABILITY INDICATION ASSAY METHOD FOR MELATONIN MFG. IN ES DUIVEN (GLD.), THE NETHERLANDS LEVAMISOLE DRUG SUBSTANCE MFG IN GEEL, BELGIUM

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4Q2012EXCEL DMF# 11016 I 11017 11018 11019 11020 I 11021 A 11022 I 11023 11024 I 11025 11026 I 11027 11028 11029 11030 I 11031 I 11032 11033 I 11034 I 11035 11036 I 11037 11038 I 11039 11040 11041 I 11042 11043 I 11044 I I 8/22/1994 ASAHI CHEMICAL INDUSTRY CO LTD I III II 8/15/1994 8/22/1994 I A III V II 7/14/1994 8/15/1994 6/24/1994 A II I 7/29/1994 8/18/1994 SONAC LOENEN BV SYNTECH CHEMICAL AND PHARMACEUTICAL CO LIFOCOLOR FARBEN GMBH SYNERGY HEALTH STERILISATION UK LTD I II I 8/16/1994 8/16/1994 JANSSEN PHARMACEUTICA NV NIELS CLAUSON-KAAS AS III 8/11/1994 EK PACK FOLIEN GMBH I II III 8/6/1994 8/15/1994 TAKASAGO INTERNATIONAL CORP MULLER PACKAGING LTD I 8/6/1994 TAKASAGO INTERNATIONAL CORP I I I II III II II 7/21/1994 8/10/1994 8/10/1994 7/27/1994 MERIND LTD MITSUI CHEMICALS INC PVP SOCIEDADE ANONIMA AVENTIS PHARMA SA I II I 8/4/1994 7/21/1994 A II II 8/2/1994 8/5/1994 BASF PHARMACHEMIKALIEN GMBH CO KG CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTD PHARM ECO LABORATORIES INC MERIND LTD II 7/31/1994 DERETIL SA II 7/31/1994 DERETIL SA I I A II II II II 8/2/1994 8/4/1994 8/1/1994 7/31/1994 STATUS Type SUBMIT DATE II 8/1/1994 HOLDER SUBJECT

4Q2012

BYK GULDEN LOMBERG CHEMISCHE FABRIK ELTENAC/B 7808-020 DRUG SUBSTANCE MFG. IN SINGEN, FEDERAL REPUBLIC OF GERMANY ESTEVE QUIMICA SA OMEPRAZOLE MFG. IN BARCELONA, SPAIN TARO PHARMACEUTICAL INDUSTRIES LTD BAYER SCHERING PHARMA AG DERETIL SA DESOXIMETASONE MFG. IN HAIFA BAY, ISRAEL ESTRONE MFG IN BERLIN AND BERGKAMEN, GERMANY D(-) ALPHA PHENYLGLYCINE DANE SALT ETHYL NPOTASSIUM MFG. IN ALMERIA, SPAIN D(-) ALPHA PARAHYDROXY PHENYLGLYCINE DANE SALT METHYL POTASSIUM MFG. IN ALMERIA, SPAIN D(-) ALPHA DIHYDRO PHENYLGLYCINE DANE SALT METHYL SODIUM MFG. IN ALMERIA, SPAIN DOBUTAMINE HYDROCHLORIDE MFG. IN MINDEN, GERMANY GLIPIZIDE MFG. IN TAIWAN, THE REPUBLIC OF CHINA 3,4,5-TRIMETHOXYBENZOYLFORMIC ACID MFG. IN LEXINGTON, MA MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL A BOMBAY, INDIA AMITRIPTYLINE HYDROCHLORIDE USP, MFG IN BOMBAY, INDIA APEL RESINS FOR DRUG PACKAGING MFG. IN YAMAGUGUCHI, JAPAN PILOCARPINE NITRATE MFG. IN PARNAIBA, BRAZIL HEMATOROPHYRINE DIHYDROCHLORIDE,PACKAGED AND TESTED IN VERTOLAYE,FRANCE MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN SHIZUOKA PREFECTURE, JAPAN A88820.605 MFG IN SHIZUOKA PREFECTURE, JAPAN COATED METAL CONTAINERS, CONICAL STEEL DRUMS MFG. IN RHEINFELDEN, FEDERAL REPUBLIC OF GERMANY EK-MINIUM S PAP 50 GMS - PE 12 MY - ALU 12 MY - SURLYN 30 GMS; PHARMACEUTICAL COMPONENT/PHARMACEUTICAL INTERMEDIATE MFG. IN ERMENGERSTWIGGENSBATCH, GERMANY VOROZOLE DRUG SUBSTANCE MFG IN GEEL, BELGIUM MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN FARUM, DENMARK HEMIN,MANUFACTURED IN GD LOENEN,THE NETHERLANDS MANUFACTURING SITE,FACILITIES,OPERATING PROCEDURES AND PERSONNEL A HSINYING,TAIWAN LIFOCOLOR RED 30858 PP,MANUFACTURED IN LICHTENFELS,GERMANY STERILE PROCESSING PROCEDURES AS LOCATED IN DAVENTRY, ENGLAND

SMITHKLINE BEECHAM PHARMACEUTICALS PENICILLIN G POTASSIUM, NON-STERILE, TECHNICAL GRADE MANUFACTURED IRVINE, CO AYRSHIRE, SCOTLAND. BASELL POLIOLEFINE ITALIA SPA LUPOLEN 3020 F MANUFACTURED IN WESSELING, (FEDERAL REPUBLIC OF GERMANY). ASAHI CHEMICAL CO LTD 2-ISOPROPL-4-(N-METHYL) AMINO-METHYL THIAZOLE MFG. IN FUKUI PREFECTURE, JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN FUKUI PREFECTURE, JAPAN Page 314

4Q2012EXCEL DMF# 11045 A 11046 A 11047 A 11048 I 11049 11050 11051 11052 I 11053 11054 11055 11056 11057 11058 11059 11060 I 11061 I 11062 A 11063 I 11064 11065 11066 11067 11068 11069 11070 I 11071 I 11072 11073 I 11074 I III 8/24/1994 CREST FLEXIBLE PACKAGING LTD I IV IV 9/2/1994 9/7/1994 NP PHARMACEUTICAL SA ELF ATOCHEM NORTH AMERICA INC III 8/18/1994 BASF AKTIENGESELLSCHAFT I N I N I I III II IV 9/2/1994 9/8/1994 8/30/1994 II 9/2/1994 III 8/29/1994 WINPAK TECHNOLOGIES INC NOT AN ASSIGNED NUMBER JOHNSON MATTHEY INC NOT AN ASSIGNED NUMBER MITSUI PETROCHEMICAL AMERICA LTD AMINO GMBH BASF SE ADMER QF550E AND SF710 MANUFACTURED IN LAPROTE, TX BETAINE, MONOHYDRATE MANUFACTURED IN FRELLSTEDT, GERMANY TRANSDERMAL PACH PRODUCT MANUFACTURED IN TORONTO, CANADA II 9/2/1994 PHARM ECO LABORATORIES INC III 9/2/1994 OBRIST OVERSEAS LTD IV 9/2/1994 A A I A I I A III II II V II II II II 8/25/1994 8/30/1994 9/1/1994 9/2/1994 9/1/1994 8/8/1994 9/1/1994 9/2/1994 PRETIUM PACKAGING ERREGIERRE SPA SELOC FRANCE MEDIMMUNE LLC PIERCE CHEMICAL CO FINE CHEMICALS CORP ROQUETTE AMERICA INC SUD CHEMIE GROUP BUSINESS UNIT RHEOLOGY PFANSTIEHL LABORATORIES INC N I A II IV I 8/26/1994 8/1/1994 8/26/1994 NOT AN ASSIGNED NUMBER FARMHISPANIA SA JRS PHARMA LP SANOFI WINTHROP INC CROMOLYN SODIUM MANUFACTURED IN BARCELONA,SPAIN I 8/17/1994 TECH PLASTICS INC MANUFACTURING SITE,FACILITIES,PERSONNELAND GENERAL OPERATING PROCEDURES MANUFACTURED IN TEMPE,ARIZONA II 8/23/1994 DEAD SEA BROMINE CO LTD II 8/23/1994 DEAD SEA BROMINE CO LTD STATUS Type SUBMIT DATE II 8/23/1994 HOLDER DEAD SEA BROMINE CO LTD SUBJECT

4Q2012

MAGNESIUM OXIDE GRADE HA5 MANUFACTURED IN MISHOR ROTEM, D.N. ARAVA, ISRAEL MAGNESIUM OXIDE GRADE HA4 MANUFACTURED IN MISHOR ROTEM,D.N. ARAVA,ISRAEL BASIC MAGNESIUM CARBONATE MANUFACTURED IN MISHOR ROTEM,D.N. ARAVA,ISRAEL

DEXTRATES, N.F. (HYDRATED), EMDEX MANUFACTURED IN CEDAR RAPIDS, IOWA MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES AT COLLEGEVIEW, PA PACKAGING MATERIAL AS MANUFACTURED IN POINTE CLAIRE, QUEBEC, CANADA BUPROPION HYDROCHLORIDE MANUFACTURED IN BERGAMO, ITALY GLYBURIDE MANUFACTURED IN SHANNON, IRELAND AND LIMAY, FRANCE STERILE PROCESSING FACILITY LOCATED IN NIJMEGEN THE NETHERLANDS EMPHAZE HEPARIN BIOSUPPORT MEDIUM MANUFACTURED IN ST. PAUL, MN MESORIDAZINE BESYLATE MANUFACTURED IN CAPE PROVINCE,SOUTH AFRICA DEXTROSE MONOHYDRATE, USP GRADE MANUFACTURED IN KEOKUK, IOWA QUATERNIUM-18 BENTONITE (BULK) MANUFACTURED IN LOUISVILLE, KY ALPHA, ALPHA-TREHALOSE DIHYDRATE, LOW ENDOTOXIN MANUFACTURED IN WAUKEGAN, IL COLLAPSIBLE ALUMINUM TUBES FOR CREAM & OINTMENTS MANUFACTURED IN REINACH, SWITZERLAND (S)-N-[2-OXO-2-(3,4,5-TRIMETHOXYPHENYL) ACETYL]PIPERIDINE-2-CARBOXYLIC ACID 1,7BIS(3-PYRIDYL)-4-HEPTYL ESTER DICITRATE SALT MANUFACTURED IN LEXINGTON, INC.

NAPHAZOLINE HYDROCHLORIDE MANUFACTURED IN WEST DEPTFORD,NEW JERSEY

KOLLIDON 17 PF MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY TERLURAN 967 K MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY SUGAR SPHERES (NEUTRAL PELLETS) MANUFACTURED IN BAZAINVILLE, FRANCE FORANES, F11, F12, AND F114 MANUFACTURED IN VIZCAYA, SPAIN AND PIERRE BENITE, FRANCE PACKAGING MATERIALS FOR MEDICAL PACKAGING (PAPER/PE/FOIL/MEL 850) 40.0G/M2 PAPER MANUFACTURED IN KENT, ENGLAND.

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4Q2012EXCEL DMF# 11075 I 11076 11077 11078 A 11079 11080 I 11081 11082 I 11083 11084 11085 11086 I 11087 11088 I 11089 I 11090 11091 I 11092 I 11093 I 11094 11095 I 11096 I 11097 11098 I 11099 11100 I 11101 I 11102 I II 9/8/1994 WHATMAN II 9/8/1994 WHATMAN I II II 9/28/1994 9/8/1994 A II II 9/23/1994 9/26/1994 ALBEMARLE CORP SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT SEPRACOR INC WHATMAN III 9/22/1994 3M PHARMACEUTICALS INC A III I 9/12/1994 9/14/1994 UNITED CLOSURES AND PLASTICS PLC ASAHI CHEMICAL INDUSTRY CO LTD III 9/9/1994 HELVOET PHARMA MARYLAND I 9/20/1994 SOCIETE INDUSTRIELLE DES OLEAGINEUX A IV II 9/19/1994 9/13/1994 QUALICAPS EUROPE SA CHEMIE LINZ GMBH II 9/16/1994 SANOFI SYNTHELABO INC. I II II 9/16/1994 9/16/1994 FINE ORGANICS LTD WYCKOFF CHEMICAL CO INC I A I II III II I 9/15/1994 8/26/1994 9/14/1994 9/16/1994 SOCHINAZ SA VISCOUNT PLASTICS AUSTRALIA ABBOTT LABORATORIES ALLERGAN INC I II II 9/3/1994 9/1/1994 A II II 9/8/1994 9/14/1994 AMINO GMBH ASAHI CHEMICAL INDUSTRY CO LTD FINE CHEMICALS DIV SUMIKA FINE CHEMICALS CO LTD KANEKA CORP A I II II II 9/13/1994 9/9/1994 9/10/1994 LAEVOSAN GMBH AND CO KG TANABE SEIYAKU CO LTD BACHEM AMERICAS INC STATUS Type SUBMIT DATE II 9/13/1994 HOLDER PURAC BIOCHEM BV SUBJECT AMMONIUM LACTATE, PURASAL NH 70 MANUFACTURED IN GORINCHEM, THE NETHERLANDS HETASTARCH FOR INJECTION MANUFACTURED IN LINZ, AUSTRIA DILTIAZEM MALATE MANUFACTURED IN YAMAGUCHI JAPAN

4Q2012

OVINE CORTICOTROPIN RELEASING FACTOR (0CRF) MANUFACTURED IN TORRANCE CALIFORNIA BETAINE MANUFACTURED IN FRELLSTEDT, GERMANY. 7-AMINOCEPHALOSPORANIC ACID (7-ACA) MANUFACTURED IN HOKKAIDO, JAPAN. CHLORPHENESIN CARBAMATE MANUFACTURED IN OKAYAMA PREFECTURE,JAPAN. N2-[1-(S)-ETHOXYCARBONYL 1-3-PHENYLPROPYL]-N6-TRIFLUOROACETYL-L-LYSYL-LPROLINE. DOBUTAMINE HCL MANUFACTURED IN VIONNAZ, SWITZERLAND. POLYPROPYLENE VIALS MANUFACTURED IN CANNING VALE, WESTERN AUSTRALIA. AMRINONE MANUFACTURED IN NORTH CHICAGO, ILLINOIS. MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN WACO, TEXAS. TVA MANUFACTURED IN CLEVELAND, ENGLAND. 5-HYDROXYMETHYLTHIAZOLE-4-NITROPHENYLCARBONATE HYDROCHLORIDE MANUFACTURED IN SOUTH HAVEN, MI. ISOETHARINE MESYLATE AND ISOETHARINE HYDROCHLORIDE MANUFACTURED IN NEW CASTLE UPON TYNE, UNITED KINGDOM AND RENSSELAER, NEW YORK.. EMPTY GELATIN CAPSULES MANUFACTURED IN ALCOBENDAS, SPAIN. N-(PHENOXYCARBONYL)-L-VALINE METHYL ESTER MANUFACTURED IN LINZ, AUSTRIA. MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES MANUFACTURED IN SAINT LAURENT BLANGY CEDEX, FRANCE. RUBBER CLOSURE FORMULATION N4013-45 RED MANUFACTURED IN SALISBURY, MARYLAND. PP28 TAMPER-EVIDENT CLICLOC III CLOSURE MANUFACTURED IN NORWICH, ENGLAND. MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURE IN HOKKAIDO, JAPAN. MSX 1154P 28% EVA COTRAN CONTROLLED CALIPER FILM MANUFACTURED IN ST. PAUL, MINNESOTA. DIPHENHYDRAMINE CITRATE, USP MANUFACTURED IN SOUTH HAVEN, MI. CLOZAPINE MANUFACTURED IN BASLE SWITZERLAND. (S)-KETOPROFEN MANUFACTYRED IN MARLBOROUGH, MA EXPRESS-ION EXCHANGER C (CARBOXYETHYL CELLULOSE)MANUFACTURED IN KENT, ENGLAND. EXPRESS-ION EXCHANGER S (SULPHOXYETHYL CELLULOSE) MANUFACTURED IN KENT, ENGLAND. EXPRESS-ION EXCHANGER D (DIETHYLAMINOETHYL CELLULOSE) MANUFACTURED IN KENT, ENGLAND.

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4Q2012EXCEL DMF# 11103 I 11104 11105 11106 I 11107 I 11108 I 11109 11110 11111 11112 11113 11114 11115 11116 11117 11118 I 11119 11120 I 11121 11122 I 11123 I 11124 11125 I 11126 I 11127 I 11128 I 11129 I 11130 A 11131 I I 10/5/1994 GLAXO SPA III 7/18/1994 KEY INTERNATIONAL INC I 9/30/1994 NUOVA OMPI SRL II 10/5/1994 NORISTAN LTD III 10/5/1994 ELF ATOCHEM III 10/5/1994 ELF ATOCHEM A IV III 9/23/1994 10/5/1994 AKZO NOBEL SURFACE CHEMISTRY LLC ELF ATOCHEM II 9/30/1994 DSM ANDENO A III II 9/28/1994 9/30/1994 I II I 9/21/1994 9/29/1994 LONZA LTD ZENECA PHARMACEUTICALS DIV ZENECA INC APTAR FRANCE SAS DSM ANDENO I I A I N I I I I III II III III III 8/31/1994 9/30/1994 8/27/1994 9/20/1994 9/21/1994 II II III III 9/29/1994 9/30/1994 9/29/1994 10/3/1994 FINE ORGANICS LTD BACHEM INC DOW CORNING CORP BELL FIBRE PRODUCTS CORP NOT AN ASSIGNED NUMBER ALUMINUM CO AMERICA WYCKOFF CHEMICAL CO INC VANLEER VERPACKUNGEN GMBH REXHAM CONTAINERS LOCTITE INTERNATIONAL PHARM 9502 MANUFACTURED IN RIVERDALE, IA. SELEGIINE MANUFACTURED IN SOUTH HAVEN, MI. FIBRE DRUMS MANUFACTURED IN COLOGNE, GERMANY. P&G 100CT HDPE BOTTLES MANUFACTURED IN FLORA,IL. IV 9/30/1994 3M PHARMACEUTICALS IV 9/30/1994 3M PHARMACEUTICALS A A II II IV 9/28/1994 9/26/1994 9/30/1994 SIEGFRIED LTD ZACH SYSTEM SA 3M PHARMACEUTICALS STATUS Type SUBMIT DATE II 9/8/1994 HOLDER WHATMAN SUBJECT

4Q2012

EXPRESS-ION EXCHANGER Q (QUATERNARY AMMONIUM CELLULOSE) MANUFACTURED IN KENT, ENGLAND. SELEGILINE HYDROCHLORIDE MANUFACTURED IN ZOFINGEN, SWITZERLAND LOTEPREDNOL ETABONATE MANUFACTURED IN ARVILLE CEDEX, FRANCE. CHLOROFLUOROCARBON PROPELLANT P-11 (TRICHLOROFLUOROMETHANE, NF) MANUFACTURED IN VIZCAYA, SPAIN FOR 3M PHARMACEUTICALS INC CHLOROFLUOROCARBON PROPELLANT P-12 (DICHLOROFLUOROMETHANE,NF) MANUFACTURED IN VIZCAYA, SPAIN FOR 3M PHARMACEUTICALS INC CHLOROFLUOROCARBON PROPELLANT P-114 (1,2DICHLOROTETRAFLUOROETHAN,NF)MANUFACTURED IN PIERRE BENITE, FRANCE FOR 3M PHARMACEUTICALS INC ATOC (ACETOXY ACID GR148460X)MANUFACTURED IN CLEVELAND,UK. GLUCAGON-LIKE PEPTIDE (7-37) MANUFACTURED IN TORRANCE, CALIFORNIA. SILASTIC QCF7-4910 UNFILLED ELASTOMER MANUFACTURED IN HEMLOCK, MI. 41713-34 MANUFACTURED IN COLUMBUS, GA.

LOCTITE 408 MANUFACTURED IN WHITESTOWN, DUBLIN 24 AND BALLYFERMOT, DUBLIN 10, IRELAND NIACINAMIDE MANUFACTURED IN VISP, SWITZERLAND MFG. SITE, FACILITIES, PERSONNEL & GENERAL OPERATING PROCEDURES IN PLANKSTADT, GERMANY APTAR GASKETS MANUFACTURED IN VAL-DE-REUIL, FRANCE R(-)-2-PHENYLGLYCINE DANE SALT (POTASSIUM, ETHYL) (KE) MANUFACTURED IN GENEVA, SWITZERLAND R (-)-2-4-HYDROXY-PHENYLGLYCINE DANE SALT (POTASSIUM , METHYL) (DP) MANUFACTURED IN GENEVA, SWITZERLAND ALCOGUM SP MANUFACTURED IN CHATTANOOGA TENNESSEE HIGH DENSITY POLYETHYLENE QUALITY LACQTENE HD 2040 MN 55 MANUFACTURED IN HARFLEUR, FRANCE. HIGH DENSITY POLYETHYLENE QUALITY LACQTENE HD 2003 SN 53 MANUFACTURED IN HARFLEUR, FRANCE. LOW DENSITY POLYETHYLENE QUALITY LACQTENE BD 1020 FN MANUFACTURED IN HARFLEUR, FRANCE. ACETYLSALICYLIC ACID (ASA) MANUFACTURED IN WALTLOO, PRETORIA, REPUBLIC OF SOUTH AFRICA. MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES MANUFACTURED IN VIA MOLINELLA,ITALY. EMPTY MOLDED SHELLS FABRICATED FROM PLASTIC FILM MANUFACTURED IN ENGLISHTOWN, NEW JERSEY. MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN S. POLO DI TORRILLE PR,ITALY. Page 317

4Q2012EXCEL DMF# 11132 11133 11134 11135 11136 11137 I 11138 11139 11140 11141 11142 11143 I 11144 11145 I 11146 11147 11148 11149 11150 11151 11152 11153 11154 11155 11156 I 11157 A 11158 I 11159 11160 11161 I 11162 11163 11164 I 11165 A IV 10/26/1994 QUALICAPS INC I A III II III 10/11/1994 10/26/1994 10/19/1994 A I III III II 9/1/1994 10/17/1994 10/24/1994 NIPRO CORP EI DUPONT DENEMOURS AND CO INC MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC MITSUI CHEMICALS INC FARCHEMIA SRL AMPACET CORP I 10/15/1994 ARTE CORP III 10/15/1994 A A A I I I I I I A III III II II II II III III III II II 10/7/1994 10/7/1994 10/21/1994 10/19/1994 10/20/1994 10/14/1994 10/17/1994 10/17/1994 10/17/1994 10/24/1994 10/24/1994 I II III 10/21/1994 10/13/1994 ABBOTT LABORATORIES JAMES RIVER CORP DIV BERLIN GORHAM GROUP CODING PRODUCTS CODING PRODUCTS FERMION OY KOKEN CO LTD ARENOL CHEMICAL CORP MITSUI PETROCHEMICAL INDUSTRIES LTD COLORS FOR PLASTICS COLORS FOR PLASTICS COLORS FOR PLASTICS AJINOMOTO PHARMACEUTICALS CO LTD DSM PHARMA CHEMICALS SOUTH HAVEN INC ARTE CORP I I A I A II II II III II I 10/13/1994 10/13/1994 10/14/1994 10/16/1994 10/18/1994 10/20/1994 SANOFI RECHERCHE WYCKOFF CHEMICAL CO INC YUNG ZIP CHEMICAL IND CO LTD CAPTIVE PLASTICS INC SYNTHESIA AS PURETEK CORP STATUS Type SUBMIT DATE A A I I I II IV II III II I 10/5/1994 10/7/1994 10/3/1994 10/11/1994 10/13/1994 10/13/1994 HOLDER CENTRAL GLASS CO LTD WAKO PURE CHEMICAL INDUSTRIES LTD SYNCHEM CHEMICALS PRIVATE LTD SUN CHEMICALS CO LTD JANSSEN PHARMACEUTICA NV KLINGE PHARMACAL GMBH SUBJECT SEVOFLURANE MANUFACTURED IN YAMAGUCHI PREFECTURE, JAPAN. POLYLACTIC ACID (PLA) MANUFACTURED IN SAITAMA PREFECTURE, JAPAN. ATENOLOL MANUFACTURED IN GUJARA, INDIA. SUNFAST PIGMENTS MANUFACTURED IN CINCINNATI, OHIO INTERMEDIATE T001168 MANUFACTURED IN GEEL AND BEERSE,BELGIUM.

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES FOR FK506 (TACROLIMUS) OINTMENT FOR CLINICAL SAMPLES IN MUNCHEN, GERMANY SR 27417A MANUFACTURED IN TOULOUSE CEDEX, FRANCE. NORFLOXACIN MANUFACTURED IN SOUTH HAVEN MI ECONAZOLE NITRATE MANUFACTURED IN TACHIA,TAIWAN,REPUBLIC OF CHINA. EXTRUSION BLOWN PLASTIC CONTAINERS MANUFACTURED IN RICHMOND,VIRGINIA. ERGOCALCIFEROL USP, MANUFACTURED IN SEMTIN, CZECH REPUBLIC MANUFACTURING SITE, FACILITIES, PERSONNEL & GENERAL OPERATING PROCEDURES IN SAN FERNANDO,CA. ATRACURIUM BESYLATE, MANUFACTURED IN NORTH CHICAGO,IL. DUNCOTE II HG 605/260 MANUFACTURED IN PORT HURON, MI. TTR-5640 THERMAL TRANSFER INK RIBBON MANUFACTURED IN KALKASKA,MI. TTR-5940 THERMAL TRANSFER INK RIBBON MANUFACTURED IN KALKASKA, MI. BUSPIRONE HYDROCHLORIDE MANUFACTURED IN ESPOO AND HANKO, FINLAND. CERAMIC HYDROXYAPAITE MANUFACTURED IN YAMAGATA-KEN,JAPAN. MAGNESIUM SALICYLATE USP,MANUFACTURED IN SOMERVILLE,NEW JERSEY. PP J858T MANUFACTURED IN ICHIHARA-CITY, CHIBA, JAPAN ACPP-10371 COLORANT MANUFACTURED IN HUNTLEY,ILLINOIS. ACPP-10378 COLORANT MANUFACTURED IN HUNTLEY,IL. ACPP-40544 COLORANT MANUFACTURED IN HUNTLEY,ILLINOIS. A-4166 MANUFACTURED IN MIE PREFECTURE, JAPAN OXAPROZIN MANUFACTURED IN SOUTH HAVEN,MI. DUAL CHAMBER PREFILLABLE SYRINGE MANUFACTURED IN IBARAKI PREFECTURE,JAPAN. MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN IBARAKI PREFECTURE, JAPAN. ELASTOMERIC CLOSURES MANUFACTURED IN OHDATE-SHI AKITA, JAPAN ZYTEL 101L NC010 MANUFACTURED IN WILMINGTON,DELAWARE. DILTIAZEM ER TABLETS MANUFACTURED IN WEST POINT, PA & KIRKLAND CANADA HZ 1300J MANUFACTURED IN ICHIHARA-CITY CHIBA,JAPAN. SULFASALAZINE MANUFACTURED IN BERGAMO,ITALY. 11416 WHITE POLYETHYLENE MASTERBATCH MANUFACTURED IN TERRE HAUTE,INDIANA,DERIDDER,LOUISIANA AND MESSANCY,BELGIUM. EMPTY GELATIN CAPSULES MANUFACTURED IN WHITSETT,NORTH CAROLINA.

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4Q2012EXCEL DMF# 11166 11167 11168 11169 I 11170 II 10/28/1994 MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC STATUS Type SUBMIT DATE I I I II II III I 10/12/1994 10/26/1994 10/21/1994 10/28/1994 HOLDER ZAMBON GROUP SPA SINTESIS QUIMICA SA ECP ENICHEM POLYMERES FRANCE ZENECA LTD SUBJECT ANA 756 MANUFACTURED IN VICENZA,ITALY. 6-AMINOPENICILLANIC ACID MANUFACTURED IN LIMA,PERU. FLEXIRENE MS20 MANUFACTURED IN DUNKIRK, FRANCE

4Q2012

I 11171 11172 I 11173 I 11174 I 11175 11176 I 11177 11178 I 11179 11180 11181 I 11182 11183 11184 11185 11186 11187 11188 A 11189 11190 11191 I 11192 11193 11194 11195 A I I A II III II II 11/12/1994 11/7/1994 11/9/1994 11/16/1994 SYNCHEM CHEMICALS PRIVATE LTD VALSPAR CORP CHEMAGIS LTD SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTD I I III III I 10/31/1994 11/4/1994 11/14/1994 INTRAPAC CORP ALUMINUM CO AMERICA BURROUGHS WELLCOME CO I I I A A I II II III III III III III 11/4/1994 11/8/1994 10/27/1994 11/11/1994 10/12/1994 11/4/1994 11/5/1994 PFANSTIEHL LABORATORIES INC CILAG AG INDUSTRIAL GOMERA SA DE CV DAK AMERICAS MISSISSIPPI INC CLARIANT MASTERBATCHES NORDEN AB ELM PLASTIC GMBH TAISEI KAKO CO LTD I I II II I 11/4/1994 10/28/1994 10/28/1994 HOECHST CELANESE CORP KANEKA AMERICA LLC KANEKA CORP I II III 10/31/1994 10/28/1994 A III I 11/2/1994 10/31/1994 NASHUA CORP PHARMACEUTICAL MANUFACTURING RESEARCH SERVICES ARENOL CHEMICAL CORP BASF AKTIENGESELLSCHAFT I 10/28/1994 ZENECA LTD III 10/14/1994 WHEATON PHARMATECH A II I 10/31/1994 10/28/1994 CADILA PHARMACEUTICALS LTD ZENECA LTD

MANUFACTURING SITE,FACILITIES,PERSONNEL & GENERAL OPERATING PROCEDURES OF THE PARENTERAL MANUFACTURING FACILITY IN MACCLESFIELD,CHESHIRE,U.K. ENALAPRIL MALEATE & DILTIAZEM ER TABLETS MFG. IN WEST POINT, PA, BALLYDINE, IRELAND BARCELONETA, PR, WILSON, NC, MERCK FROSST FACILITIES IN KIRKLAND, QUEBEC, CA, MARION MERRELL DOW FACILITIES IN KANSAS CITY,MO & PACO PACKAGING, LAKEWOOD NJ. ETHAMBUTOL HC1 MANUFACTURED IN GUJARAT,INDIA. MANUFACTURING SITE, FACILITY, PERSONNEL AND GENERAL OPERATING PROCEDURES OF THE GOSERELIN BULK DRUG PLANT IN MACCLESFIELD, CHESHIRE, U.K. RUBBER CLOSURE FORMULATION B5006-50 BLACK MANUFACTURED IN SALISBURY,MD. MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES FOR THE STERILE PRODUCT PLANT IN MACCLESFIELD, CHESHIRE UK. PBL-3 MANUFACTURED IN MERRIMACK,NH. MANUFACTURING SITE,FACILITIES,PERSONNEL & GENERAL OPERATING PROCEDURES IN HORSHAM, PA. COPPER GLYCINATE MONOHYDRATE MANUFACTURED IN SOMERVILLE, NJ. STYROLUX KR 2691 MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY. GLYBURIDE MANUFACTURED IN COVENTRY, RHODE ISLAND UBIDECARENONE MANUFACTURED IN TAKASAGOSHI, HYOGO, JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES AT TAKASAGO-SHI HYOGO, JAPAN PHOSPHOLIPIDS, EGG MANUFACTURED IN WAUKEGAN, IL IRI -695 MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND BUTYL STOPPER COMPOUND MANUFACTURED IN ESTADO DE MEXICO, MEXICO PERMACLEAR POLYETHYLENE TEREPHTHALATE MANUFACTURED IN DARLINGTON, SC PP 12455 MANUFACTURED IN JARNYXEGATAN 7, MALMO, SWEDEN DOSING PIPETTES MANUFACTURED IN GEWERBEGEBIET, DUSSELDORF CONTAINERS FOR PULMONARY,NASAL,ORAL, THROAT,SUBLINGUAL OR EAR MANUFACTURED IN GIFU AND OSAKA, JAPAN LAMINATE TUBES MANUFACTURED IN SWEDESBORO, NEW JERSEY PHAR 9503 MANUFACTURED IN PITTSBURGH, PENNSYLVANIA MANUFACTURING SITE, FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN GREENVILLE, NORTH CAROLINA. NADOLOL MANUFACTURED IN GUJARARA, INDIA TPL-301 CLEAR COATING MANUFACTURED IN KOTO-KU, TOKYO,JAPAN. FENOFIBRATE MANUFACTURED IN BEER SHEVA, ISREAL. CLOZAPINE MANUFACTURED IN SHANGHAI, PEOPLE'S REPUBLIC OF CHINA.

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4Q2012EXCEL DMF# 11196 11197 I 11198 A 11199 I 11200 11201 I 11202 11203 I 11204 11205 11206 A 11207 11208 11209 I 11210 11211 11212 11213 I 11214 A 11215 I 11216 I 11217 11218 11219 I 11220 11221 11222 I 11223 I 11224 I IV 11/30/1994 I 12/5/1994 A A III III I 10/28/1994 11/18/1994 11/7/1994 I I II II I 11/30/1994 10/7/1994 11/21/1994 III 11/30/1994 II 11/30/1994 HALOCARBON LABORATORIES DIV HALOCARBON PRODUCTS CORP HALOCARBON LABORATORIES DIV HALOCARBON PRODUCTS CORP SANOFI SYNTHELABO INC. TIANJIN PHARMACEUTICAL CORP PAPIERFABRIK DIV SCHOELLER AND HOESCH GMBH TAKEUCHI PRESS INDUSTRIES CO LTD KITANO CO LTD PHARMASOL LTD HALOTHANE MANUFACTURED IN NORTH AUGUSTA,S.C. IV 11/30/1994 STEPAN CO MAYWOOD DEPT I I I II IV II I 11/23/1994 11/15/1994 11/21/1994 11/22/1994 INTERQUIM SA DEXTER NONWOVENS DIV TOAGOSEI CO LTD ZENECA LTD I I II II I 11/15/1994 11/23/1994 11/23/1994 A I II III III 11/22/1994 11/10/1994 11/7/1994 BACHEM SA KUHN KUNSTSTOFFWERK BORMIOLI ROCCO E FIGLIO SPA BU PLASTICA SENN CHEMICALS ASH STEVENS INC INTERQUIM SA I II I 11/15/1994 11/15/1994 UNITED BREWERIES LTD UNITED BREWERIES LTD A II III 11/15/1994 11/11/1994 JOHNSON MATTHEY INC AMPACET CORP I 10/24/1994 INPAC AB IV 11/11/1994 JRS PHARMA GMBH AND CO KG STATUS Type SUBMIT DATE I II I 11/14/1994 11/11/1994 HOLDER NORDIC SYNTHESIS AB DEGUSSA AG SUBJECT BUPROPION HYDROCHLORIDE MANUFACTURED IN KARLSKOGA, SWEDEN.

4Q2012

MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN WEISSENBORN, GERMANY. UNITAB, MICROCRYSTALLINE CELLULOSE MANUFACTURED IN WEISSENBORN, GERMANY. MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN LUND, SWEDEN. FENTANYL HYDROCHLORIDE MANUFACTURED IN WEST DEPTFORD, NEW JERSEY 110406 WHITE POLYPROPYLENE MASTERBACH MANUFACTURED IN TERRE HAUTE, INDIANA, DERIDDER, LOUISANA, OR MESSANCY, BELGIUM IBUPROFEN USP MANUFACTURED IN TUMKUR, INDIA. MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES A TUMKUR,INDIA. PROPOFOL MANUFACTURED IN VIONNAZ,SWITZERLAND. PLASTIC CAPS (MOULDED),MANUFACTURED IN BIETIGHEM/BADEN, GERMANY CHILD-PROOF CAP. 0 28 MM MANUFACTURED IN CASTELGUELFO,ITALY. THYROTROPIN RELEASING HORMONE MANUFACTURED IN DIELSFDORF,SWITZERLAND. P-BORONO-L-PHENYLALANINE (B-10 ENRICHED) MANUFACTURED IN RIVERVIEW,MI. MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN BARCELONA, SPAIN DOTARIZINE MANUFACTURED IN BARCELONA, SPAIN TRANSDERMAL MEDICATION FABRIC MANUFACTURED IN WINDSOR LOCKS, CT TOAGOSEI GIGAPITE (HYDROXY APAITE MANUFACTURED IN NAGOYA, JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES OF GROUP NO.1 PLANT IN MACCLESFIELD, CHESHIRE, U.K. WECOBEE SS, HYDROGENATED VEGETABLE OIL MANUFACTURED IN PORT NEWARK, NJ

HALOTHANE PACKAGING MATERIAL MANUFACTURED IN NORTH AUGUSTA,SC. BEFLOXATONE MANUFACTURED BY FINORGA SA IN CHASSE SUR RHONE, FRANCE. PREDNISOLONE MANUFACTURED IN TIANJIN,CHINA. MANUFACTURING SITE,FACILITIES,PERSONNEL & GENERAL OPERATING PROCEDURES IN GERNSBACH,GERMANY. ALUMINIUM COLLAPSIBLE TUBES MANUFACTURED IN TOYAMA,JAPAN. POLYETHYLENE CAPS MANUFACTURED IN TOYAMA,JAPAN.

MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN ANDOVER HAMPSHRE,UNITED KINGDOM. ROQUETTE FRERES SA MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN LESTREM,FRANCE. HENRY H OTTENS MANUFACTURING CO INC SPRAY DRIED ARTIFICIAL STRAWBERRY OIL S-464 MANUFACTURED IN PHILADELPHIA,PENNSYLVANIA.

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4Q2012EXCEL DMF# 11225 I 11226 I 11227 11228 11229 11230 11231 I 11232 11233 11234 11235 11236 11237 I 11238 11239 I 11240 A 11241 11242 I 11243 I 11244 I 11245 11246 11247 A 11248 11249 11250 I 11251 I 11252 11253 I 11254 I III 12/19/1994 SOLVAY DRAKA INC I II III 12/16/1994 12/12/1994 JANSSEN PHARMACEUTICA NV RENKER GMBH AND CO KG I 12/27/1994 SKW BIOTECHNOLOGICAL CO LTD I A II III I 9/5/1995 12/19/1994 12/15/1994 HAUSER CHEMICAL RESEARCH INC CYTEC INDUSTRIES INC MERCIAN CORP I I II II IV 12/13/1994 12/8/1994 12/12/1994 HOVIONE SOCIEDADE QUIMICA SA KNOLL AG LIPOID GMBH III 12/6/1994 II 11/29/1994 SHANDONG XINHUA PHARMACEUTICAL FACTORY FPC FLEXIBLE PACKAGING CORP I II III 12/13/1994 12/8/1994 V 12/7/1994 AMERICAN PHARMACEUTICAL PARTNERS INC NAGASE FINE CHEMICALS LTD AMPACET CORP I III I 12/1/1994 12/8/1994 AMERICAN POLYMERS INC INTERNATIONAL PROCESSING CORP I A A I A II II III III II I 12/1/1994 12/5/1994 11/28/1994 11/15/1994 12/8/1994 12/9/1994 RHONE POULENC CHIMIE DS PHARMA ANIMAL HEALTH CO LTD REXAM HEALTHCARE OFFRANVILLE SAS PARM PRECISION PLASTICS BACHEM AMERICAS INC LEIRAS OY I I A I II II II II I 12/1/1994 12/16/1994 11/15/1994 11/28/1994 11/29/1994 I 11/28/1994 STATUS Type SUBMIT DATE II 11/29/1994 HOLDER PHARM ECO LABORATORIES INC SUBJECT

4Q2012

(3)-TETRAHYDRO-3-FURYL-N-[91S,2R)-3-2-HYDROSYPROPYL]CARBAMATE MESYLATE MANUFACTURED IN N.ANDOVER,MA. BAUSCH AND LOMB PHARMACEUTICALS INC MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN TAMPA,FLORIDA. MALLINCKRODT CHEMICAL INC SODIUM HYDROGEN L-TARTRATE MANUFACTURED IN ST. LOUIS, MISSOURI BORYUNG PHARMACEUTICAL CO LTD RELIABLE BIOPHARMACEUTICAL CORP ECP ENICHEM POLYMERES FRANCE METRICS INC CAPTOPRIL MANUFACTURED IN KYONGGI-DO, KOREA. ETOMIDATE MANUFACTURED IN ST. LOUIS, MISSOURI RIBLENE MR10 MANUFACTURED IN DUNKIRK, FRANCE MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN GREENVILLE, NORTH CAROLINA SALICYLIC ACID MANUFACTURED IN ROUSSILLON, FRANCE ORBIFLOXACIN MANUFACTURED IN SUZUKA-SHI,MIE, JAPAN THERMO-PLASTIC MATERIALS MANUFACTURED IN DIEPPE CEDEX,FRANCE. PACKAGING MATERIALS MANUFACTURED IN ERIE,PA. LEUPROLIDE ACETATE, MANUFACTURED IN TORRANCE, CALIFORNIA MANUFACTURING SITE, FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN TURKU,FINLAND. PACKAGING MATERIALS MANUFACTURED IN OXFORD,MA. MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN WINCHESTER,KY. LIQUID DRUGS IN VIALS ASEPTIC FILL PROGRAM IN GRAND ISLAND,NY. 2',3',5' TRI-O-ACETYLURIDINE MANUFACTURED IN HYOGO-PREFECTURE,JAPAN. 10761 AB/AS POLYETHYLENE MASTERBATCH MANUFACTURED IN TERRE HAUTE,INDIANA,DERIDDER,LOUISIANA,AND MESSANCY, BELGIUM. IBUPROFEN BP 88/USP XXII MANUFACTURED IN SHANDONG,CHINA. PAPER/FOIL/POLYETHYLENE POUCH, FPC SPECIFICATION NUMBER 43521X MANUFACTURED IN ONTARIO,CANADA. IOPAMIDOL MANUFACTURED IN LOURES, PORTUGAL. CARBIDOPA MANUFACTURED IN LIESTAL,SWITZERLAND. LIPOID PC 14:/14:0,1.2-DIMYRISTOYLSN-GLYCERO-3-PHOSPHO CHOLINE MANUFACTURED IN LUDWIGSHAFEN,FEDERAL REPUBLIC OF GERMANY. PACLITAXEL MANUFACTURED IN BOULDER, COLORADO. AEROTEX 3730 RESIN MANUFACTURED IN WALLINGFORD,CONNECTICUT. MANUFACTURING SITE,FACILITIES,PERSONNEL,AND GENERAL OPERATING PROCEDURES IN SHIZUOKA, JAPNA. MANUFACTURING SITE, FACILITIES,PERSONNEL, AND GENERAL OPERATING PROCEDURES MANUFACTURED IN BUDAPEST, HUNGARY. DRAFLAZINE MANUFACTURED IN GEEL,BELGIUM. BIAXIALLY ORIENTED POLYPROPYLENE 40 MICRON COATED ON THE PRETREATED SIDE WITH A HAZY COATING MANUFACTURED IN FREIBURG, GERMANY. SOLMED 100 WHITE FILM MANUFACTURED IN LAPORTE, IN.

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4Q2012EXCEL DMF# 11255 I 11256 11257 I 11258 I 11259 I 11260 I 11261 I 11262 11263 I 11264 I 11265 I 11266 11267 A 11268 11269 11270 11271 I 11272 I 11273 11274 11275 I 11276 11277 11278 11279 I 11280 11281 11282 11283 I A I I II III II III 1/4/1995 3/1/1995 1/5/1995 12/23/1994 TEVA PHARMACEUTICAL INDUSTRIES LTD ECP ENICHEM POLYMERES FRANCE KANEKA CORP CARCANO ANTONIO S.P.A I A I II III III I 12/29/1994 12/20/1994 1/5/1995 1/6/1995 TAKASAGO INTERNATIONAL CORP LEXINGTON RUBBER GROUP INC DSM POLYMERS VITRO ENVASES NORTEAMERICA I A II II I 12/28/1994 12/27/1994 12/29/1994 KANEKA SINGAPORE CO PTE LTD DAIICHI FINE CHEMICAL CO LTD TAKASAGO INTERNATIONAL CORP I 12/30/1994 ONO PHARMACEUTICAL CO LTD I I I II III II I 12/28/1994 12/7/1994 12/27/1994 12/30/1994 I II II 12/19/1994 12/23/1994 CHIREX LTD LABORATORIO CHIMICO INTERNAZIONALE SPA HAUSER CHEMICAL RESEARCH INC SEAL LINE SPA GUERBET CHIMIE AULNAY SA CIPLA LTD II 12/16/1994 FINE ORGANICS LTD II 12/16/1994 FINE ORGANICS LTD I II III 12/25/1994 12/16/1994 INALCO SPA VARI SPA I 11/25/1994 INALCO SPA MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN PISTOIA, ITALY LACTULOSE CRYSTALS MANUFACTURED IN PISTOIA, ITALY III 12/16/1994 HELVOET PHARMA MARYLAND III 12/16/1994 HELVOET PHARMA MARYLAND I 12/19/1994 CREATIVE PRODUCTS INC I II II 12/21/1994 12/21/1994 DERETIL SA PHARM ECO LABORATORIES INC STATUS Type SUBMIT DATE III 12/19/1994 HOLDER LILLY FRANCE SA SUBJECT

4Q2012

QUALITY CONTROL PROCEDURES FOR IN-COMING INSPECTION OF PACKAGING COMPONENTS USED IN FEGERSHEIM FRANCE D (-) ALPHA PHENYLGLYCINE MANUFACTURED IN ALMERIA, SPAIN. 2-NSA-FORMALDEHYDE CONDENSATE, SODIUM SALT-FRACTIONATED MANUFACTURED IN LEXINGTON, MA MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES RUBBER CLOSURE FORMULATION B5320-45 BLACK MANUFACTURED IN SALISBURY, MD RUBBER CLOSURE FORMULATION B5311-55 BLACK MANUFACTURED IN SALISBURY, MD

AEROSOL VALVES, METERED DOSE AEROSOL VALVES, ORAL ADAPTERS-MOUTHPIECE, MANUFACTURED IN OLGINATE(LC) ITALY LO287 (CRUDE LOTEPREDNOL ETABONATE) MANUFACTURED IN CLEVELAND, ENGLAND 2-ISOPROPYL-4-(N-METHYLAMINO)METHL-THIAZOLE MANUFACTURED IN CLEVELAND, ENGLAND ACETOXY ACID GR 148460X MANUFACTURED IN NORTHUMBERLAND, ENGLAND. DICLOFENAC POTASSIUM MANUFACTURED IN SEGRATE (MILAN), ITALY MX-DTPA KEY INTERMEDIATE MANUFACTURED IN BOULDER, COLORADO. RUBBER STOPPERS MANUFACTURED IN MONTEGALDELLA, ITALY. IOXITOL MANUFACTURED IN LANESTER, FRANCE. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KURKUMBH, INDIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FUKUI, JAPAN. HPG DANE SALT MANUFACTURED IN GUL CRESCENT SINGAPORE. DINOPROSTONE (PROSTAGLANDIN E2) MANUFACTURED IN TOYAMA, JAPAN. MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERTAING PROCEDURES IN SHIZUOKA, JAPAN. A-87172.0 MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN. PACKAGING MATERIAL MANUFACTURED IN VIENNA, OH. STAMYLAN LD 2102TN26 MANUFACTURED IN BECK, THE NETHERLANDS. MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN MONTERREY, MEXICO.D.F., TLANEPANTLA AND GUADALAJARA, MEXICO. MESALAZINE N MANUFACTURED IN SAVSKI MAROF, CROATIA FLEXIRENE CM30 MANUFACTURED IN DUNKIRK, FRANCE. KPM-1648 MANUFACTURED IN HYOGO, JAPAN ALUMINIUM FOIL FOR BLISTERS COVER MANUFACTURED IN MANDELLO DEL LARIO-COITALY Page 322

4Q2012EXCEL DMF# 11284 I 11285 I 11286 I 11287 11288 I 11289 A 11290 A 11291 A 11292 11293 11294 11295 11296 A 11297 I 11298 I 11299 I 11300 11301 11302 11303 I 11304 11305 I 11306 11307 11308 11309 I 11310 11311 I 11312 I III 1/9/1995 SONOCO PRODUCTS CO A III IV 1/20/1995 1/25/1995 HENKEL CORP GENZYME PHARMACEUTICALS LLC I A A III V II I 1/19/1995 12/7/1994 1/18/1995 1/11/1995 WINPAK TECHNOLOGIES INC APP PHARMACEUTICALS LLC KATWIJK CHEMIE BV BRECON PHARMACEUTICALS LTD I IV I 1/12/1995 1/17/1995 F AND C WILD FLAVORS INC SAMHWA LUBE OIL CO LTD ARTIFICIAL PUNCH FLAVOR #FAAF896 MANUFACTURED IN CINCINNATI, OHIO. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KANGWON PROVINCE, SOUTH KOREA. VAGISTA POUCHES MANUFACTURED IN TORONTO, ONTARIO. TERMINAL STERILIZATION PROGRAM IN GRAND ISLAND, NEW YORK. OXAPROZIN MANUFACTRUED IN KATWIJK AAN ZEE, THE NETHERLANDS. A I I II II II II 1/16/1995 12/7/1994 1/16/1995 12/30/1994 TEVA PHARMACEUTICAL INDUSTRIES LTD SYNTHELABO PHARMACIE CHIRON MIMOTOPES PEPTIDE SYSTEMS GUANGDONG PHARMACEUTICAL FACTORY I 1/9/1995 LUPIN CHEMICALS LTD IV 1/6/1995 UNION CARBIDE CORPORATION I 1/9/1995 KAKEN PHARMACEUTICAL CO LTD I I I A IV III III III II 1/5/1995 1/6/1995 1/6/1995 12/21/1994 1/9/1995 EASTMAN CHEMICAL CO PCD POLYMERE GMBH PCD POLYMERE GMBH BOREALIS AG KAKEN PHARMACEUTICAL CO LTD II 1/9/1995 LUPIN LTD II 1/11/1995 II 10/7/1994 TIANJIN TIANYAO PHARMACEUTICALS CO LTD JIANGSU HENGRUI MEDICINE CO LTD PREDNISONE MANUFACTURED IN TIANJIN, CHINA. I II III 12/29/1994 12/20/1994 DOW CHEMICAL CO CEBAL ITALIANA I 1/3/1995 ADITHYA ALKALOIDS LTD MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MAHABOONAGAR DISTRICT NEAR HYDERABAD,INDIA. VERSENE NA CHELAING AGENT MANUFACTURED IN FREEPORT, TX II 1/3/1995 ADITHYA ALKALOIDS LTD STATUS Type SUBMIT DATE II 1/3/1995 HOLDER ADITHYA ALKALOIDS LTD SUBJECT

4Q2012

VINBLASTINE SULFATE MANUFACTURED IN MEHBOOB NAGAR DISTRICT NEAR HYDERABAD, INDIA. VINCRISTINE SULFATE MANUFACTURED IN MEHBOOB NAGAR NEAR HYDERABAD, INDIA.

ALUMINIUM TUBES MANUFACTURED IN CIVIDATE AL PIANO BG AND TORTONA AL, ITALY

IFOSFAMIDE USP MANUFACTURED IN LIANYUNGANG CITY, PEOPLE'S REPUBLIC OF CHINA. RIFAMYCIN-S (BULK SUBSTANCE) (ESUB) AS MANUFACTURED IN TARAPUR, MAHARASHTRA, INDIA. TRIACETIN (PLASTICIZER) USP MANUFACTURED IN KINGSPORT, TENNESSEE. POLYPROPYLENE GRADE DAPLEN TOP SEAL MANUFACTURED IN LINZ,AUSTRIA. DAPLEN KF 201 T 50 PHARM MANUFACTURED IN LINZ, AUSTRIA. POLYPROPYLENE GRADE HF320FBP MANUFACTURED IN LINZ, AUSTRIA. KP-363 BUTENEAFINE HYDROCHLORIDE MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SHIZUOKA PREFECTURE, JAPAN. SENTRY PLUS POLYVINYL ACETATE MANUFACTURED IN SOUTH CAROLINA, WEST VIRGINIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TARAPUR, INDIA. TERAZOSIN HYDROCHLORIDE MANUFACTURED IN MILANO, ITALY. L-LYSINE AQUEOUS SOLUTION MANUFACTURED IN AMILLY, FRANCE. CT-112 MANUFACTURED IN SAN DIEGO, CALIFORNIA. ECONAZOLE NITRATE MANUFACTURED IN FUNGCUN DADAO, GUANGZHOUG, CHINA.

MANUFACTURING SITE, FACILITIES, PERESONNEL, AND GENERAL OPERATING PROCEDURES IN HEREFORD, ENGLAND. TPX 16-159 MANUFACTURED IN KANKAKEE, ILLINOIS. N-(CARBAMONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SNGLYCERO-3-PHOSPHOETHANOLAMINE SODIUM SALT (MPEG-DSPE) AS MANUFACTURED IN LIESTAL, SWITZERLAND. SPC-TM-506 MANUFACTURED IN DAYTON, NEW JERSEY.

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4Q2012EXCEL DMF# 11313 I 11314 11315 11316 I 11317 11318 I 11319 11320 11321 A 11322 A 11323 I 11324 I 11325 11326 11327 11328 I 11329 I 11330 11331 I 11332 11333 11334 11335 11336 11337 11338 11339 11340 11341 I 11342 A 11343 I I 2/14/1995 V 2/13/1995 AMERICAN PHARMACEUTICAL PARTNERS, INC. ELF ATOCHEM I I I I I I A A A III III III II II II II II II I 1/27/1995 1/27/1995 1/27/1995 2/7/1995 12/2/1996 2/3/1995 2/10/1995 2/10/1995 2/9/1995 2/9/1995 PCD POLYMERE GES MBH PCD POLYMERE GES MBH PCD POLYMERE GES MBH PHARMACIA AND UPJOHN INC ANTIBIOTIC CO JANSSEN PHARMACEUTICA NV DELTA SYNTHETIC CO LTD DELTA SYNTHETIC CO LTD SAFC INC TETRIONICS INC I III II 1/27/1995 1/16/1995 PCD POLYMERE GES MBH BK LADENBURG GMBH III 1/31/1995 CREST FLEXIBLE PACKAGING LTD A A I III III II II 1/24/1995 1/24/1995 2/6/1995 2/7/1995 CODING PRODUCTS CODING PRODUCTS JANSSEN PHARMACEUTICA NV SP PHARMACEUTICALS LLC I 1/26/1995 CALBIOCHEM NOVABIOCHEM AG I 1/31/1995 SM ORGANICS PRIVATE LTD III 2/2/1995 ALUBERG SPA A I II IV III 1/20/1995 1/20/1995 1/15/1995 KYOWA HAKKO KIRIN CO LTD DAVID MICHAEL AND CO INC STEVANATO GROUP SPA I II I 1/25/1995 1/13/1995 FUJI PHOTO FILM CO LTD SUPERFOS PACKAGING A/S A A II II I 12/31/1994 1/26/1995 1/25/1995 SAFC BIOSCIENCES INC FERMION OY FUJI PHOTO FILM CO LTD STATUS Type SUBMIT DATE III 1/20/1995 HOLDER RESCO COLOURS INC SUBJECT

4Q2012

O6EHD-895 (AMBER CONCENTRATE) MANUFACTURED IN ONTARIO, CANADA AND CONVENTRY, RHODE ISLAND. EX-CELL 405 WITH L-GLUTAMINE MANUFACTURED IN DENVER, PENNSYLVANIA. FLUOXETINE HYDROCHLORIDE MANUFACTURED IN HANKO, FINLAND. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. FP-21399 MANUFACTURED IN KANAGAWA PREFECTURE, JAPAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. UCN-01 (KW-2401) BULK SUBSTANCE MANUFACTURED IN TOKYO, JAPAN ARTIFICIAL CHERRY FLAVOR 13233 MANUFACTURED IN PHILADEPHIA, PA GLASSWARE CONTAINERS FOR PHARMACETUICAL USAGE MANUFACTURED IN PIOMBINO DESE, ITALY LACQUERED ALUMINUM FOIL DRUG PACKAGING MATERIALS MANUFACTURED IN BERGAMO, ITALY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HARYANA, INDIA. MANUFACTURING SITE, FACILITIES,PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LAUFELFINGEN, SWITZERLAND. SV-11618, A HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MI. SV-11521 A HOT STAMP INK RIBBON MANUFACTURED IN KALKASKA, MI. SUFENTANIL CITRATE MANUFACTURED IN GEEL, BELGIUM. 9-AMINOCAMPTOTHECIN COLLOIDAL DISPERSION AND DILUENT MANUFACTURED IN ALBUQUERQUE, NEW MEXICO. PACKAGING MATERIALS FOR MEDICAL PACKAGING (PET/FOIL/PE) MANUFACTURED IN KENT, ENGLAND. POLYPROPYLENE GRADE DAPLEN MSC 3006 A MANUFACTURED IN LINZ, AUSTRIA. PHOSKADENT SF-SODIUM FLUORIDE MANUFACTURED BY BAYER AG IN LEVERKUSENBAYERWERK, GERMANY. POLYPROPYLENE GRADE DAPLEN CHC 3007 MANUFACTURED IN LINZ, AUSTRIA. POLYPROPLYENE GRADE DAPLEN COD 9007 MANUFACTURED IN LINZ, AUSTRIA. POLYPROPYLENE GRADE DAPLEN MOC 9006 A MANUFACTURED IN LINZ, AUSTRIA. 9-AMINOCAMPTOTHECIN ACTIVE DRUG SUBSTANCE MANUFACTURED IN MILAN, ITALY. LOVASTATIN, MANUFACTURED IN RAZGARD, BULGARIA ALFENTANIL HYDROCHLORIDE MANUFACTURED IN GEEL, BELGIUM. LIDOCAINE HYDROCHLORIDE MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA. LIDOCAINE MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA. 19-NOR-1A, 25-DIHYDROXY VITAMIN D2 MANUFACTURED IN MADISON WI MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MADISON, WI. LIQUID AND LYOPHILIZED DRUGS IN VIALS ASEPTIC FILL PROGRAM IN MELROSE PARK, IL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ALONSOTEGUI, SPAIN.

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4Q2012EXCEL DMF# 11344 I 11345 11346 I 11347 I 11348 11349 11350 I 11351 11352 I 11353 11354 I 11355 I 11356 11357 I 11358 I 11359 11360 11361 I 11362 11363 11364 A 11365 11366 11367 11368 A 11369 11370 I 11371 I 11372 I V 3/9/1995 PHARMACO LIFE SCIENCE RESEARCH I 3/9/1995 TORPHARM INC A III IV 2/15/1995 2/28/1995 PLASTIQUES MICRON INC J MANHEIMER INC A I I II IV II III 2/23/1995 2/28/1995 3/1/1995 2/24/1995 HOSPIRA INC KYOWA HAKKO KOGYO CO LTD POWDERSIZE INC AMPACET CORP I I III II IV 2/22/1995 2/27/1995 3/2/1995 TUREX INC BIOSEPRA INC SYMRISE INC A I II III III 2/20/1995 2/22/1995 2/9/1995 AMSA SPA ELM PLASTIC GMBH SENSORMATIC ELECTRONICS CORP I 2/23/1995 BIO INTERMEDIAIR BV MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GRONINGEN, THE NETHERLANDS. ETODOLAC (ESUB) AS MANUFACTURED IN COMO, ITALY. MEASURING DISHES MANUFCTURED IN DUDELDORF, GEWERBEGEBIET. A II III 2/20/1995 2/13/1995 RESOLUTION CHEMICALS LIMITED SOLVAY AND CIE SA I 2/22/1995 RTI INC I III I 2/21/1995 2/15/1995 A II II 2/17/1995 2/20/1995 CAMBREX PROFARMACO MILANO SRL LEK LJUBLJANA PHARMACEUTICAL AND CHEMICAL CO WATSON LABORATORIES INC SA ALCON COUVREUR NV I I II II III 2/13/1995 2/14/1995 2/10/1995 PROMETIC BIOSCIENCES LTD BRISTOL MYERS SQUIBB COMPANY AMPACET CORP I 2/10/1995 HEUMANN PHARMA GMBH AND CO A II I 2/10/1995 2/13/1995 MALLINCKRODT INC ARAB MEDICAL CONTAINERS CO LTD STATUS Type SUBMIT DATE I 2/14/1995 HOLDER ELF ATOCHEM SUBJECT

4Q2012

MANUFACTURING SITE, FACILITIES,PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PIERRE-BENITE, FRANCE. MEPERIDINE HYDROCHLORIDE, USP (ESUB) MANUFACTURED IN ST. LOUIS, MISSOURI. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SAHAB, JORDAN. MANUFACTURING SITE, PERSONNEL, FACILITIES, AND GENERAL OPERATING PROCEDURES IN FEUCHT, GERMANY. MIMETIC GREEN 1 A6XL MANUFACTURED IN ISLE OF MAN, GREAT BRITAIN. TRIAMCINOLONE DIACETATE, STERILE MANUFACTURED IN HUMACAO, PUERTO RICO. 11898 WHITE POLYETHYLENE MASTERBACH MANUFACTURED IN TERRE HAUTE, INDIANA, DERIDDER, LOUISIANA AND AMPACET EUROPE S.A. IN MESSANCY, BELGIUM. CLONAZEPAM MANUFACTURED IN MILANO, ITALY. ACYCLOVIR ACTIVE SUBSTANCE MANUFACTURED IN KOLODVORSKA, SLOVENIA. PACKAGING MATERIALS AS MANFACTURED IN COPIAGUE, NY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PUURS, BELGIUM. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SALEM, NEW JERSEY. SELEGILINE HYDROCHLORIDE MANUFACTURED IN HERTFORSHIRE, UNITED KINGDOM. HIGH DENSITY POLYETHYNE ELTEX B3002/33 MANUFACTURED IN SARRALBE, FRANCE.

OUTLOOK FILM #71WX38 MANUFACTURED BY OUTLOOK GRAPHICS IN NEENAH, WISCONSIN. LD-640N MANUFACTURED IN NASONVILLE, RHODE ISLAND PROTEIN A-HYPER D. MANUFACTURED IN VILLENEUVE LA GARENNE, FRANCE. MICROSEAL NATURAL AND ARTIFICIAL ORANGE FLAVOR 9/79J839 MANUFACTURED IN TOTOWA, NEW JERSEY H324/38 EMULSION FOR INFUSION MANUFACTURED IN CLAYTON, NORTH CAROLINA SODIUM HYALURONATE MANUFACTURED IN UBESHI YAMAGUCHI-KEN JAPAN CONTRACT MICRONIZATION SERVICES LOCATED IN QUAKERTOWN, PA. 110080 WHITE POLYETHYLENE MASTERBACH MANUFACTURED IN TERRE HAUTE, INDIANA, DERIDDER, LOUISIANA, OR AMPACET EUROPE, S.A. MESSANCY, BELGIUM. PLASTIC CONTAINERS MANUFACTURED IN QUEBEC CANADA NATURAL AND ARTIFICIAL GRAPE FLAVOR 522463 MANUFACTURED IN LONG ISLAND CITY, NEW YORK MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ONTARIO, CANADA. METHOD VALIDATION, GC/MS ANALYSIS OF TRINITROGLYCERIN, 1,2, DINITROGLYCERIN AND 1,3 DINITROGLYCERIN IN HUMAN PLASMA, METHOD MS42.1 MANUFACTURED IN RICHMOND, VIRGINIA. Page 325

4Q2012EXCEL DMF# 11373 11374 11375 11376 I 11377 I 11378 11379 11380 I 11381 I 11382 I 11383 11384 11385 I 11386 11387 11388 I 11389 11390 11391 11392 A 11393 11394 I 11395 11396 11397 11398 A 11399 I 11400 I 11401 I 11402 11403 A A III V 3/23/1995 3/27/1995 I 3/23/1995 I 3/24/1995 II 3/13/1995 A I A II III III IV 3/24/1995 1/16/1995 3/20/1995 3/22/1995 TAKEDA PHARMACEUTICAL CO LTD MYLAN TECHNOLOGIES INC NASHUA CORP AMCOL HEALTH AND BEAUTY SOLUTIONS INC PURITAN BENNETT CORP I II II 3/15/1995 3/22/1995 BOEHRINGER INGELHEIM PHARMA KG RANBAXY LABORATORIES LTD A I I II II II III 3/17/1995 3/15/1995 3/15/1995 2/1/1995 SIFAVITOR SRL JANSSEN PHARMACEUTICA NV BACHEM FEINCHEMIKALIEN AG NUSSBAUM MATZINGEN AG I A IV II I 3/8/1995 3/15/1995 3/15/1995 A A III III II 3/6/1995 3/6/1995 3/15/1995 SOLVIN SA SOLVIN SA JIANGSU TIANQING PHARMACEUTICAL FACTORY J MANHEIMER INC APOTEX PHARMACHEM INC MW ENCAP LTD III 3/6/1995 SOLVIN S.A. I 3/15/1995 SS ORGANICS LTD A A II II I 3/16/1995 3/13/1995 3/7/1995 CAMBRIDGE ISOTOPE LABORATORIES INC DIPHARMA FRANCIS SRL DIXIE CHEMICAL CO INC I 3/12/1995 FERMIC SA DE CV STATUS Type SUBMIT DATE A I A II II IV I 3/6/1995 3/3/1995 3/9/1995 3/10/1995 HOLDER NOVACYL SAS OMNICHEM SA WACKER CHEMIE AG BUNDER GLAS GMBH SUBJECT ASPIRIN MANUFACTURED IN SAINT-FONS, FRANCE BOC CORE SUCCINATE A88820.605 MANUFACTURED IN WETTEN, BELGIUM GAMMA CYCLODEXTRIN MANUFACTURED IN MUNCHEN, GERMANY MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN BUNDE, GERMANY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MEXICO, D.F., MEXICO. C-13 UREA MANUFACTURED IN ANDOOVER, MASSACHUSETTS.

4Q2012

URSODEOXYCHOLIC ACID MANUFACTURED IN CARONNO PERTUSELLA (VA), ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PASADENA, TEXAS. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SADASIVAPET MANDIA, INDIA. DIOFAN DS 2319 X MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY. DIOFAN A-736 MANUFACTURED IN TAVAUX, FRANCE DIOFAN A-716 MANUFACTURED IN TAVAUX, FRANCE FOSCARNET SODIUM MANUFACTURED IN XINU, LIANYUNGANG CITY, PEOPLE'S REPUBLIC OF CHINA. NATURAL ORANGE WONF 608352 MANUFACTURED IN LONG ISLAND CITY, NEW YORK. WARFARIN SODIUM MANUFACTURED IN ONTARIO, CANADA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN WEST LOTHIAN, UNITED KINGDOM. CICLOPIROX OLAMINE MANUFACTURED IN MILANO, ITALY. INTERMEDIATE T001310 MANUFACTURED IN GEEL, BELGIUM TEMURTIDE MANUFACTURED IN BUBENDORF, SWITZERLAND. COLLAPSIBLE ALUMINUM TUBES AND PLASTIC CLOSURES MANUFACTURED IN KESSWIL, SWITZERLAND. CROTAMITON MANUFACTURED IN INGELHEIM/RHEIN. 7-AMINO-3-CHLORO-3-CEPHEM-4-CARBONXYLIC ACID-DRUG SUBSTANCE INTERMEDIATE MANUFACTURED IN PUNJAB, INDIA. TAP-144-SR (C-LINE) MANUFACTURED IN OSAKA, JAPAN. 2229 PEELABLE RELEASE LINER MANUFACTURED IN ST. ALBANS, VERMONT. BM-4 (LABEL ADHESIVE) MANUFACTURED IN MERIMACK, NEW HAMPSHIRE.

METHYL METHACRYLATE/ETHYLENE GLYCOL DIMETHACRYLATE COPOLYMER MICROSPONGE (APS PRODUCT CODE: E101-04) MANUFACTURED IN LAFAYETTE, LA NITRIC OXIDE IN NITROGEN GAS MIXTURE MANUFACTURED IN OVERLAND PARK, KANSAS. SMITHKLINE BEECHAM PHARMACEUTICALS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CUERNAVACA, MEXICO. UPJOHN FARMOQUIMICA SA MANUFACTURING SITE, FACILITIES, PERSONNNEL, AND GENERAL OPERATING PROCEDURES IN MADRID, SPAIN. BAYER MATERIALSCIENCE LLC MAKROLON 2658-1112 MANUFACTURED IN BAYTOWN, TEXAS. APP PHARMACEUTICALS LLC TERMINAL STERILZATION PROGRAM IN MELROSE PARK, ILLINOIS.

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4Q2012EXCEL DMF# 11404 A 11405 A 11406 11407 I 11408 I 11409 I 11410 I 11411 I 11412 I 11413 11414 I 11415 I 11416 I 11417 I 11418 I 11419 I 11420 I 11421 A 11422 11423 I 11424 I 11425 I 11426 11427 11428 I A A II III I 4/3/1995 3/28/1995 4/3/1995 PROCOS SPA NASHUA CORP JANSSEN PHARMACEUTICA NV III 3/27/1995 RESCO COLOURS INC III 3/27/1995 RESCO COLOURS INC A II III 4/4/1995 3/27/1995 ALBEMARLE CORP RESCO COLOURS INC II 3/31/1995 MALLINCKRODT INC II 3/31/1995 PHARM ECO LABORATORIES INC II 3/30/1995 FINORGA SA III 3/27/1995 RESCO COLOURS INC V 4/3/1995 KOLMI SET OY III 3/24/1995 IV 3/22/1995 I II IV 3/28/1995 3/13/1995 SANOFI AVENTIS US INC QUEST INTERNATIONAL FLAVORS AND FOOD INGREDIENTS CO QUEST INTERNATIONAL FLAVORS AND FOOD INGREDIENTS CO GERRESHEIMER BUNDE GMBH V 3/28/1995 II 3/28/1995 ZENECA SPECIALITIES SUB NOVACOTE INTERNATIONAL PHARMACO LIFE SCIENCE RESEARCH I 3/29/1995 DSM ANDENO GMBH II 3/29/1995 DSM ANDENO BV I 3/24/1995 SAUREFABRIK SCHWEIZERHALL A II II 3/29/1995 3/28/1995 CILAG AG AVANTI POLAR LIPIDS INC PROPOFOL MANUFCTURED IN SCHAFFHAUSEN, SWITZERLAND. II 3/29/1995 STATUS Type SUBMIT DATE III 3/15/1995 HOLDER MYLAN TECHNOLOGIES INC SUBJECT MEDIFLEX 1200 and MEDIFLEX 1501 (ESUB) MANUFACTURED IN ST. ALBANS, VERMONT. PHARMACEUTICAL WORKS POLPHARMA SA ETODOLAC MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND.

4Q2012

1,2-DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOCHOLINE MANUFACTURED IN ALABASTER, ALABAMA. MANUFACTURING SITE FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES I SCHWEIZERHALLE, SWITZERLAND. L-VALINE-N-(PHENOXYCARBONYL)-METHYLESTER (VAPOX-M) MANUFACTURED IN VENLO, THE NETHERLANDS. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN REGENSBURG, GERMANY. HYDROXYSULPHONE FC4010 MANUFACTURED IN MANCHESTER, UNITED KINGDOM. METHOD GC32,GC ANALYSIS OF SELEGILINE IN HUMAN PLASMA AND METHOD GC33 REVISION 1, GC ANALYSIS OF AMPHETAMINE METHAPHETAMINE AND DESMETHYSELEGILINE IN HUMAN PLASMA MANUFACTURED IN RICHMOND, VIRGINIA. MDL 101,731 MANUFACTURED IN MIDLAND, MICHIGAN. ARTIFICIAL RASPBERRY DYO4447 MANUFACTURED IN OWINGS MILLS, MARYLAND. ARTIFICIAL STRAWBERRY FLAVOR DY04359 MANUFACTURED IN OWINGS MILLS, MARYLAND. PRIMARY PACKAGING MATERIAL FOR PHARMACEUTICAL PRODUCTS MADE FROM TUBULAR GLASS MANUFACTURED IN BUNDE, FEDERAL REPUBLIC OF GERMANY. GAMMA STERILIZATION AS CARRIED OUT BY MOLNLYCKE HEALTH CARE OY IN ILOMANTSI, FINLAND ORANGE CONCENTRATE (90PPP-158) MANUFACTURED IN ONTARIO, CANADA AND COVENTRY, RHODE ISLAND. PHENYLOXYCARBONYL-(L)-VALINE METHYL ESTER MANUFACTURED IN CHASSE-SURRHONE, FRANCE. 1,4-BIS[5-(2-IMIDAZOLINYL)-2-BENZIMIDAZOLYL]BUTANE TETRAHYDROCHLORIDE MANUFACTURED IN LEXINGTON, MASSACHUSETTS. NALBUPHINE HYDROCHLORIDE (LOW BETA EPIMER) CODE 3310 (ESUB) MANUFACTURED IN ST. LOUIS, MONTANA 2,6-DIISOPROPYPHENOL(DIP) MANUFACTURED IN ORANGEBURG, SOUTH CAROLINA. GREEN CONCENTRATE (50PPP-488) MANUFACTURED IN ONTARIO, CANADA AND CONVENTRY, RHODE ISLAND. YELLOW CONCENTRATE (30PPP-260)MANUFACTURED IN ONTARIO, CANADA AND CONVENTRY, RHODE ISLAND. ORANGE CONCENTRATE (90PPP-160)MANUFACTURED IN ONTARIO, CANADA AND CONVENTRY, RHODE ISLAND PROPAFENONE HYDROCHLORIDE MANUFACTURED IN CAMERI-NOVARA, ITALY. PC-79 HEAT SEAL ADHESIVE MANUFACTURED IN MERRIMACK, NEW HAMPSHIRE. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN OLEN, BELGIUM.

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4Q2012EXCEL DMF# 11429 11430 11431 A 11432 11433 11434 11435 A 11436 I 11437 I 11438 11439 11440 11441 11442 11443 11444 11445 11446 11447 11448 11449 11450 I 11451 I 11452 11453 I 11454 11455 11456 11457 11458 I 11459 11460 11461 I 11462 I IV 4/21/1995 ROQUETTE FRERES SA I I III III I 4/11/1995 4/10/1995 3/23/1995 PCD POLYMERE GMBH ECP ENICHEM POLYMERES FRANCE SCIPAC LTD A A I I IV II II II II 4/17/1995 4/17/1995 4/17/1995 4/17/1995 4/17/1995 I II III 3/24/1995 3/20/1995 II 4/14/1995 A I I I I I I I I I I A II III III III III III III III III III II II II 4/11/1995 4/11/1995 4/11/1995 4/11/1995 4/11/1995 4/11/1995 4/11/1995 4/11/1995 4/11/1995 4/11/1995 4/11/1995 4/17/1995 4/14/1995 JANSSEN PHARMACEUTICA NV PCD POLYMERE GMBH PCD POLYMERE GMBH BOREALIS AG BOREALIS AB PCD POLYMERE GMBH PCD POLYMERE GMBH PCD POLYMERE GMBH PCD POLYMERE GMBH PCD POLYMERE GMBH SOLVAY DUPHAR BV CIPLA LTD CONSOLIDATED PHARMACEUTICAL GROUP INC CONSOLIDATED PHARMACEUTICAL GROUP INC KYOWA HAKKO KOGYO CO LTD KNIGHT ENGINEERING AND PLASTICS DIV COURTAULDS PACKAGING BAYER SCHERING PHARMA AG ALDRICH CHEMICAL CO ISOTEC FACILITY SAFC BIOSCIENCES INC SAFC BIOSCIENCES INC JRH BIOSCIENCES I 4/6/1995 YONEZAWA HAMARI CHEMICALS CO LTD II 4/5/1995 GRANULES INDIA LTD I I I II II III II 4/7/1995 4/7/1995 4/10/1995 4/5/1995 SANKYO CO LTD SANKYO CO LTD DUOPAC PACKAGING INC NTP RADIOISOTOPES LTD STATUS Type SUBMIT DATE I I II IV III 4/7/1995 4/6/1995 3/31/1995 HOLDER BIOSEPRA INC DRAGOCO GERBERDING AND CO AG MONDI KORNEUBURG GMBH SUBJECT LYSINE-HYPER D MANUFACTURED IN VILLENEUVE LA GARENNE, FRANCE.

4Q2012

BLOOD ORANGE FLAVORING 9/028658 MANUFACTURED IN HOLZMINDEN, GERMANY. ALUMINUM LAMINATE & ALUMINUM LAMINATE POUCH MANUFACTURED IN KORNEUBURG, AUSTRIA CS-866 DRUG PRODUCT MANUFACTURED IN TOKYO, JAPAN. CS-866 DRUG SUBSTANCE MANUFACTURED IN TOKYO, JAPAN. ROUND AND OBLONG HDPE BOTTLES MANUFACTURED IN LAVAL, CANADA MOLYBDENUM-99 (FISSION) MANUFACTURED IN PRETORIA, REPUBLIC OF SOUTH AFRICA. COMPRESSO-90-P (ACETAMINOPHEN GRANULES 90%) MANUFACTURED IN HYDERABAD, INDIA MANUFACTURING SITE, FACILITY PERSONNEL AND GENERAL OPERATING PROCEDURES IN YAMAGATA, JAPAN. RISPERIDONE DRUG SUBSTANCE MANUFACTURED IN GEEL, BELGIUM POLYPROPYLENE GRADE DAPLEN KFC 2004 SB MANUFACTURED IN LINZ, AUSTRIA. POLYPROPYLENE GRADE DAPLEN KFC 2208 SB MANUFACTURED IN LINZ, AUSTRIA. POLYPROPYLEN GRADE DAPLEN KFC 2104 SB MANUFACTURED IN LINZ, AUSTRIA. POLYPROPYLENE GRADE DAPLEN USC 1012A MANUFACTURED IN LINZ, AUSTRIA. POLYPROPYLENE GRADE DAPLEN DH 5973 MANUFACTURED IN LINZ, AUSTRIA. POLYPROPYLENE GRADE DAPLEN CF 501 MANUFACTURED IN LINZ, AUSTRIA. POLYPROPYLENE GRADE DAPLEN PT 551 S MANUFACTURED IN LINZ, AUSTRIA. POLYPROPYLENE GRADE DAPLEN KFC 2008 MANUFACTURED IN LINZ, AUSTRIA. POLYPROPYLENE GRADE DAPLEN DH 5273 MANUFACTURED IN LINZ, AUSTRIA. LACTULOSE CONCENTRATE MANUFACTURED IN WEESP, THE NETHERLANDS. FELODIPINE (ESUB) MANUFACTURED IN CIPLA-VIKHROLI, BOMBAY, INDIA. AMPICILLIN TRIHYDRATE BPC MANUFACTURED IN BALTIMORE, MARYLAND. AMOXICILLIN TRIHYDRATE BPC MANUFACTURED IN BALTIMORE, MARYLAND. DX-52-1 BULK MATERIAL MANUFACTURED IN TOKYO, JAPAN. PLASTIC CONTAINERS MANUFACTURED IN ARLINGTON HEIGHTS, ILLINOIS AND WOODSTOCK, ILLINOIS. PDMS 373 TW MANUFACTURED IN TURKU, FINLAND. UREA-13 C MANUFACTURED IN MIAMISBURG, OHIO. 67210 MANUFACTURED IN DENVER, PENNSYLVANIA. 62180 MANUFACTURED IN DENVER, PENNSYLVANIA. PHOSPHATE BUFFERED SALINE (PRODUCT 62137) MANUFACTURED IN DENVER, PENNSYLVANIA. POLYPROPYLENE GRADE DAPLEN KFC 2004 MANUFACTURED IN LINZ, AUSTRIA. RIBLENE FF20 MANUFACTURED IN DUNKIRK, FRANCE. MANUFACTURING SITE, FACILITIES, PERSONNEL,AND GENERAL OPERATING PROCEDURES IN SITTINGBOURNE, KENT. MALTODEXTRIN FOR PERITONEAL DIALYSIS MANUFACTURED IN LESTREM, FRANCE.

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4Q2012EXCEL DMF# 11463 A 11464 11465 11466 I 11467 I 11468 I 11469 11470 11471 11472 I 11473 I 11474 I 11475 I 11476 I 11477 I 11478 I 11479 I 11480 11481 I 11482 I 11483 I 11484 I 11485 11486 11487 11488 11489 I A I I I III II II IV I 4/26/1995 5/12/1995 5/1/1995 5/1/1995 5/5/1995 II 4/28/1995 II 4/28/1995 II 4/28/1995 I II II 4/28/1995 4/28/1995 BOEHRINGER INGELHEIM CHEMICALS INC CONSOLIDATED PHARMACEUTICAL GROUP INC CONSOLIDATED PHARMACEUTICAL GROUP INC CONSOLIDATED PHARMACEUTICAL GROUP INC CONSOLIDATED PHARMACEUTICAL GROUP INC SELIG SEALING PRODUCTS INC NAGASE FINE CHEMICALS LTD ASTRA MERCK INC ANDREA AROMATICS INC SOREBIO I 4/26/1995 JANSSEN CILAG SPA II 4/27/1995 SELOC AG III 4/25/1995 REXAM CLOSURE SYSTEMS INC I 4/20/1995 PERLOS OYJ III 4/25/1995 II 4/26/1995 ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV GRUPPO MOSSI AND GHISOLFI I 4/5/1995 KLINGE PHARMACAL GMBH I I I II III III II 4/12/1995 4/19/1995 4/19/1995 4/19/1995 MEDICHEM SA COLORS FOR PLASTICS COLORS FOR PLASTICS DSM ANDENO GMBH IV 4/20/1995 BRISTOL MYERS SQUIBB COMPANY III 1/24/1995 DANAPAK FLEXIBLES A I II II III 4/12/1995 4/19/1995 12/13/1995 NOF CORP ARZNEIMITTELWERK DRESDEN GMBH KERPLAS SNC STATUS Type SUBMIT DATE II 4/12/1995 HOLDER NOF CORP SUBJECT

4Q2012

DIMYRISTOYLPHOSPHATIDYLGLYCEROL AMMONIUM/SODIUM SALT MANUFACTURED IN HYOGO, JAPAN. DIMYRISTOYL PHOSPHATIDYL CHOLINE MANUFACTURED IN HYOGO, JAPAN. CHLORHEXIDINE (BASE) MANUFACTURED IN RADEBEUL, GERMANY. PLASTIC BOTTLE 15, 20, 30, 60, 100 AND 160ML PEHD WHITE MANUFACTURED IN DIEPPE, FRANCE. COMPOUND PACKAGING MATERIAL 3RCUXXXX MANUFACTURED IN ODENSE S. DENMARK. PLASTIBASE 10W (PLASTICIZED HYDROCARBON GEL) MANUFACTURED IN HUMACAO, PUERTO, RICO. BUSPIRONE HYDROCHLORIDE MANUFACTURED IN CELRA (GERONA) SPAIN ACPP-40581 MANUFACTURED IN HUNTLEY, ILLINOIS. ACPP-10397 MANUFACTURED IN HUNTLEY, ILLINOIS. L-VALINE, N-(PHENOXYCARBONYL)-METHYLESTER (VAPOX-M) MANUFACTURED IN REGENSBURG, GERMANY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES FOR ZOTEPINE SUGAR-COATED TABLETS IN MUNCHEN, GERMANY. PROPOFOL MANUFACTURED IN NORTH CHICAGO, ILLINOIS POLYETHYLENE NAPHTHALATE RESINS MANUFACTURED IN APPLE GROVE, WEST VIRGINIA. MANFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LEHMO, FINLAND. PLASTIC LINING MATERIALS MANUFACTURED BY OWNES-BROCKWAY SPECIALTY PRODUCTS IN ERIE, PA. OXYBUTYNIN BASE MANUFACTURED A SIFA LTD. IN CO. CLARE IRELAND AND SICOR S.A. IN LIMAY, FRANCE. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BORGO SAN MICHELE, ITALY RANITIDINE HYDROCHLORIDE USP MANUFACTURED IN PETERSBURG, VIRGINIA. AMOXICILLIN TRIHYDRATE CAPSULES MANUFACTURED IN BALTIMORE, MARYLAND. AMPICILLIN TRIHYDRATE FOR ORAL SUSPENSION MANUFACTURED IN BALTIMORE, MARYLAND. AMOXICILLIN TRIHYDRATE FOR ORAL SUSPENSION MANUFACTURED IN BALTIMORE, MARYLAND. AMPICILLIN TRIHYDRATE CAPSULES MANUFACTURED IN BALTIMORE, MARYLAND. BOTTLE CAP LINING MATERIALS MANUFACTURED IN AURORA, ONTARIO, CANADA. S-KETOPROFEN MANUFACTURED IN HYOGO , JAPAN. TCV-116 MANUFACTURED IN OSAKA, JAPAN. FRAGRANCE FORMULATION L-93-12514 MANUFACTURED IN TRENTON, NEW JERSEY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MARITILLAC, FRANCE.

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4Q2012EXCEL DMF# 11490 I 11491 I 11492 I 11493 I 11494 I 11495 A 11496 I 11497 11498 A 11499 11500 I 11501 11502 11503 11504 11505 11506 I 11507 11508 11509 A 11510 I 11511 11512 11513 I 11514 A 11515 11516 I 11517 I II 5/19/1995 I II II 5/2/1995 5/19/1995 3V INC CONSOLIDATED PHARMACEUTICAL GROUP INC CONSOLIDATED PHARMACEUTICAL GROUP INC III 5/12/1995 MAC CLOSURES INC A I III III II 5/9/1995 5/9/1995 5/11/1995 SONOCO FLEXIBLE PACKAGING SONOCO FLEXIBLE PACKAGING GRANULES INDIA LTD III 5/8/1995 I I II II III 5/15/1995 5/12/1995 5/8/1995 MAPRIMED SA LYNX THERAPEUTICS INC CLARIANT MASTERBATCHES DIVISION CLARIANT CANADA INC RESCO COLOURS INC A C A I I II II III II II III 5/11/1995 5/12/1995 5/8/1995 5/11/1995 5/12/1995 5/9/1995 I II III 5/11/1995 4/10/1995 ASSIA CHEMICAL INDUSTRIES LTD I III II 5/1/1995 5/8/1995 IV 5/5/1995 IV 4/28/1995 II 5/8/1995 I 5/3/1995 II 4/26/1995 SIGMA CHEMICAL CO IV 2/27/1995 DAVID MICHAEL AND CO INC STATUS Type SUBMIT DATE I 4/25/1995 HOLDER FLUKA CHEMICAL CO SUBJECT

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BUCHS, SWITZERLAND. NATURAL AND ARTIFICIAL ORANGE FLAVOR #12728 MANUFACTURED IN PHILADEPHIA, PA. CHOLESTREROL, PRODUCT NUMBER W 5179-2 MANUFACTURED IN ST. LOUIS, MISSOURI.

INDUSTRIE CHIMIQUE MULHOUSE DORNACH MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MULHOUSE, FRANCE. BIOSEPRA INC OCTYL AT SPHERODEX M MANUFACTURED AT BIOSEPRA SA, VILLENEUVE-LA-GARENNE, FRANCE. MANTROSE HAEUSER CO INC 25% AMMONIATED SHELLAC SOLUTION MANUFACTURED IN ATTLEBORO, MASSACHUSETTS. FLAVORS NORTH AMERICA INC 884.114 NOR-CAP NATURAL AND ARTIFICIAL ORANGE FLAVOR MANUFACTURED IN CAROL STREAM, ILLINOIS. CREST PLASTICS PLASTIC CONTAINERS MANUFACTURED IN SCARBOROUGH, CANADA. SERONO INC MURINE MONOCLONAL ANTI-FSH ANTIBODY 9/14 MANUFACTURED BY SOREBIO SA IN MARTILLAC, FRANCE. DICLOFENAC SODIUM MANUFACTURED IN PETAH TIQVA, ISRAEL.

ROWO COATING GMBH FUR BESCHICHTUNG POLYESTER FILM 15 MICRON ONE SIDE ALUMINIZED) MANUFACTURED IN HERBOLZHEIM, GERMANY. PIERRE FABRE MEDICAMENT MILNACIPRAN HYDROCHLORIDE MANUFACTURED IN GAILLAC, FRANCE. TEVA PHARMACEUTICAL INDUSTRIES LTD TICONA GMBH DOCTOR REDDYS LABORATORIES LTD LEO PHARMACEUTICAL PRODUCTS LTD POLYMER COLOR INC LOVASTATIN USP BULK MANUFACTURED I DEBRECEN, HUNGARY. KEMATAL ACETAL COPOLYMER MANUFACTURED IN KELSTERBACH, GERMANY. DILTIAZEM HYDROCHLORIDE MANUFACTURED IN ANDHRA PRADESH, INDIA. EB 1089 EC-CAPSULES DRUG PRODUCT MANUFACTURED IN BALLERUP, DENMARK. WLC-12486, 25/1 WHITE COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS. KETOROLAC TROMETHAMINE MANUFACTURED IN BUENOS AIRES, ARGENTINA. LR-3280 MANUFACTURED IN HAYWARD, CALIFORNIA. WHITE CONCENTRATE (01PPP-072) MANUFACTURED IN ONTARIO, CANADA AND CONVENTRY, RHODE ISLAND. WHITE CONCENTRATE (01EHD-260) MANUFACTURED IN ONTARIO, CANADA AND CONVENTRY, RHODE ISLAND. MPE953M-1 MANUFACTURED IN ENDINBURGH, INDIANA. MPE95WA-1 MANUFACTURED IN ENDINBURGH, INDIANA. COMPRESSO-90-CP(F) (ACETAMINOPHEN GRANULES 90%) MANUFACTURED IN HYDERABAD, INDIA. KERR CR-1 CONTINUOUS THREADED CHILD-RESISTANT CLOSURE MANUFACTURED IN WATERLOO, QUEBEC, CANADA. UVASORB MET/C MANUFACTURED IN GEORGETOWN, SOUTH CAROLINA. PENICILLIN V POTASSIUM FOR ORAL SOLUTION, USP MANUFACTURED IN BALTIMORE, MARYLAND. PENICILLIN V POTASSIUM TABLETS, USP MANUFACTURED IN BALTIMORE, MARYLAND.

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4Q2012EXCEL DMF# 11518 I 11519 11520 A 11521 I 11522 11523 I 11524 A 11525 11526 11527 I 11528 I 11529 A 11530 I 11531 A 11532 I 11533 I 11534 11535 A 11536 11537 11538 I 11539 I 11540 11541 I 11542 11543 11544 I I I II II II 5/31/1995 6/1/1995 6/2/1995 DSM ANDENO GMBH MAPRIMED SA MAHARISHI AYUR VED PRODUCTS INTL INC I II I 5/22/1995 5/31/1995 ALDRICH CHEMICAL CO INC E PHARMA SPA POLYGALACTURONIC ACID MANUFACTURED IN SHEBOYGAN FALLS, WI. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN VIA PROVINA, ITALY. MBT-ESTER MANUFACTURED IN REGENSBURG, GERMANY. III 5/23/1995 AMPACET CORP I A III II II 5/30/1995 6/5/1995 5/26/1995 SABIC PETROCHEMICALS BV GEDEON RICHTER PLC BORON BIOLOGICALS INC I II II 5/31/1995 5/26/1995 II 5/25/1995 III 5/19/1995 IV 5/25/1995 IV 5/25/1995 II 7/6/1995 I 5/19/1995 A I II II I 5/19/1995 5/19/1995 5/11/1995 FARMHISPANIA SA IROTEC LABORATORIES PIERRE FABRE SANTE II 5/24/1995 CIPLA LTD A II I 5/23/1995 5/15/1995 FERMION OY RHONE POULENC RORER SA III 5/22/1995 SCHUEPBACH AG I II III 5/19/1995 5/19/1995 PLAISTOW LTD PACKAGING COORDINATORS LLC STATUS Type SUBMIT DATE I 5/19/1995 HOLDER TIANJIN XIN XIN PHARMACEUTICAL CORP SUBJECT

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TIANJIN, CHINA. LEVOBUNOLOL HYDROCHLORIDE MANUFACTURED IN LITTLE ISLAND, CORK, IRELAND. MANUFACTURING SITE, FACILTIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PHILADELPHIA, PA.TYPE I CONVERSION TO TYPE III COMPOUND PACKAGING MATERIAL PAPER/ALUMINUM/OPA/PAN-BAREX MATERIAL SOP 50962 MANUFACTURED IN BURGDORF, SWITZERLAND. FLUTAMIDE MANUFACTURED IN ESPOO, FINLAND. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN VITRY-SUR-SEINE CEDEX, FRANCE. FLUCONAZOLE (ESUB) AS MANUFACTURED IN VIKHROLI BOMBAY, INDIA, AND PATALGANGA, INDIA. ENALAPRIL MALEATE MANUFACTURED IN BARCELONA, SPAIN. TRAMADOL HYDROCHLORIDE MANUFACTURED IN LITTLE ISLAND, CORK, IRELAND.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GAILLAC, FRANCE. LYNX THERAPEUTICS INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HAYWARD, CA. MALLINCKRODT INC MORPHINE SULFATE INJECTION USP (ESUB) AS MANUFACTURED IN RALEIGH, NORTH CAROLINA. HENRY H OTTENS MANUFACTURING CO INC SPRAY DRIED NATURAL/ARTIFICIAL KIWI FLAVOR S-718 MANUFACTURED IN PHILADELPHIA, PA. HENRY H OTTENS MANUFACTURING CO INC SPRAY DRIED NATURAL ORANGE FLAVOR WONF S-261 MANUFACTURED IN PHILADEPHIA, PA. AMPACET CORP 100102 ANTISTAT POLYETHYLENE MASTERBATCH MANUFACTURED IN TERRE HAUTE, INDIANA, DERIDDER, LOUISIANA, OR AMPACET EUROPE, S.A., MESSANCY, BELGIUM. TORONTO RESEARCH CHEMICALS INC SUCROSE OCTASULFATE, POTASSIUM SALT MANUFACTURED IN DOWNSVIEW, ONTARIO, CANADA. ONO PHARMACEUTICAL CO LTD PROSTAGLANDIN E1 MANUFACTURED IN FUKUI, JAPAN. FARMHISPANIA SA 1-[N2-[(S)-1-CARBOXY-3-PHENYLPROPYL]-L-LYSYL]-L-PROLINE DIHYDRATE MANUFACTURED IN BARCELONA, SPAIN. SABIC HDPE B5309 MANUFACTURED IN AA BEEK, THE NETHERLANDS. FAMOTIDINE MANUFACTURED IN BUDAPEST, HUNGARY. 10B-ENRICHED L-P-BORONOPHENYLALANINE MANUFACTURED IN RALEIGH, NORTH CAROLINA. 100221-A ANTISTAT POLYETHYLEN MASTERBATCH MANUFACTURED IN TERRE HAUTE, INDIANA, DERIDDER, LOUISIANA OR AMPACET EUROPE S.A., MESSANCY, BELGIUM.

RANITIDINE HYDROCHLORIDE MANUFACTURED IN BUENOS AIRES, ARGENTINA. MAHARISHI MARIT KALASH (MAK-4 AND MAK-5) MANUFACTURED IN NOIDA, UP INDIA.

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4Q2012EXCEL DMF# 11545 I 11546 11547 I 11548 11549 11550 11551 A 11552 I 11553 I 11554 11555 I 11556 I 11557 11558 I 11559 11560 A 11561 11562 11563 A 11564 11565 A 11566 I 11567 11568 11569 I 11570 I 11571 11572 11573 I I I II II I 6/25/1995 7/7/1995 6/29/1995 TECHCO CHEMICAL CO LTD ABBOTT LABORATORIES 3M HEALTH CARE LTD III 6/27/1995 AMPACET CORP A A IV II III 6/28/1995 6/29/1995 6/27/1995 GATTEFOSSE SA FERMION OY SCHUEPBACH AG I 6/8/1995 SEITZ FILTER WERKE A II III 6/5/1995 6/16/1995 A A II II II 5/31/1995 6/20/1995 7/6/1995 NOF CORP FARCHEMIA SRL A III III 6/8/1995 6/12/1995 TICONA GMBH CLARIANT CORP A III III 6/9/1995 6/12/1995 CLARIANT CORPORATION SCHUEPBACH AG I 6/13/1995 SANOFI RECHERCHE I II II 6/12/1995 6/12/1995 AVANTI POLAR LIPIDS INC ORGANON NV II 6/12/1995 AVANTI POLAR LIPIDS INC II 6/12/1995 I I I III II II II 6/5/1995 6/9/1995 6/1/1995 6/9/1995 POLYMER COLOR INC PLANTEX LTD XIAN PHARMACEUTICAL FACTORY I II III 5/31/1995 6/1/1995 STATUS Type SUBMIT DATE I 6/1/1995 HOLDER SUBJECT GREAT LAKES CHEMICAL KONSTANZ GMBH MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KONSTANZ, GERMANY. DOCTOR REDDYS LABORATORIES LTD RANITIDINE MANUFACTURED IN ANDHRA PRADESH, INDIA. RESCO COLOURS INC

4Q2012

AMBER CONCENTRATE (06EDH-950) MANUFACTURED IN MISSISSAUGA,ONTARIO, CANADA, AND COVENTRY, RHODE ISLAND. RLC-14321, 25/1 PINK COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS PENTOXIFYLLINE MANUFACTURED BY PLANTEX LTD IN NETANYA, ISRAEL. DEMETHYLEPIPODOFILOX MANUFACTURED IN SHAANXI PROVINCE, CHINA.

UNION QUIMICO FARMACEUTICA SA UQUIFA OMEPRAZOLE MANUFACTURED IN BARCELONA, SPAIN SA AVANTI POLAR LIPIDS INC 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPATE MANUFACTURED IN ALABASTER, ALABAMA. 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE-N-(POLYETHYLENE GLYCOL 5000) MANUFACTURED IN ALABASTER, ALABAMA. IMARX SYNTHETIC PHOSPHOLIPID BLEND MANUFACTURED IN ALABASTER, ALABAMA DESOGESTREL TABLETS (75UG AND 150UG) MANUFACTURED IN OSS, THE NETHERLANDS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LABEGE CEDEX, FRANCE WPC-116, 33/1 WHITE COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINIOS COMPOUND PACKING MATERIAL PAPER/ALUMINIUN/POLYETHYENE MATERIAL #SOP 25330 MANUFACTURED IN BURGDORF, SWITZERLAND HOSTAFORM ACETAL COPOLYMER MANUFACTURED IN KELSTERBACH, GERMANY. WPA-116B, 25/1 WHITE COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS. PURIFIED EGG YOLK PHOSPHATIDYLCHOLINE MANUFACTURED IN HYOGO JAPAN. MICONAZOLE NITRATE MANUFACTURED IN TREVIGLIO, ITALY.

CHINOIN PHARMACEUTCIAL AND CHEMICAL DINOPROSTONE (PROSTAGLANDIN E2) MANUFACTURED IN BUDAPEST, HUNGARY. WORKS CO LTD ALBEMARLE CORP LIDOCAINE USP MANUFACTURED IN SOUTH HAVEN, MI. STYROLUTION GMBH POLYSTYROL 158 K KO 21 GK 00013 MANUFACTURED IN LUDWIGSHAFEN, GERMANY AND ANTWERPEN 4, BELGIUM. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES FOR SEITZ MEMBRACART PS MEMBERANE FILTER CARTRIDGES IN BAD KREUZNACH, FEDERAL REPUBLIC OF GERMANY. PECEOL ISOTEARIQUE MANUFACTURED IN SAINT-PRIEST CEDEX, FRANCE. PROPAFENONE HCL MANUFACTURED IN ESPOO, ENGLAND. COMPOUND PACKAGING MATERIAL ACLAR FLUROPOLYMER/POLYVINYLCHORIDE FILM (PVC) MATERIAL #SOP 56019 MANUFACTURED IN BURGDORF, SWITZERLAND. LR-86344 ANTISTA POLYETHYLENE MASTERBACH MANUFACTURED IN TERRE HAUTE, INDIANA, DERIDDER, LOUISIANA OR AMPACET EUROPE, S.A., MESSANCY, BELGIUM. 7-ADCA MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA. MSI-78 MANUFACTURED IN NORTH CHICAGO, ILLINOIS. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES BY 3M NEOTECHNIC LIMITED IN LEICESTERSHIRE, ENGLAND. Page

332

4Q2012EXCEL DMF# 11574 11575 11576 11577 I 11578 A 11579 11580 11581 I 11582 A 11583 11584 11585 I 11586 11587 I 11588 11589 11590 I 11591 11592 I 11593 11594 I 11595 11596 11597 I 11598 I 11599 I 11600 11601 11602 I I A II IV II 8/15/1995 7/27/1995 2/5/1996 ZENTIVA KS CFC CONSORTIUM UNION QUIMICO FARMAEUTICA, S.A. (UQUIFA) III 8/15/1995 MONTELL SDK SUNRISE LTD III 7/18/1995 CARCANO ANTONIO S.P.A. A I II II II 7/21/1995 7/25/1995 7/6/1995 COPPERHEAD INVESTMENTS INC ARCHIMICA SPA PALMER RESEARCH I II I 7/20/1995 7/20/1995 A II II 8/14/1995 7/20/1995 I I II III II 7/19/1995 4/20/1995 7/19/1995 MITSUBISHI CHEMICAL CORP AB VAXJOPLAST BOMBAY DRUGS AND PHARMACEUTICALS LTD NV ORGANON LOHMANN THERAPIE SYSTEME GMBH AND CO KG NV ORGANON ANTIBIOTICOS A II II 7/12/1995 7/17/1995 BASF SE HOECHST MARION ROUSSEL SA A I II II I 7/11/1995 7/13/1995 7/14/1995 FARCHEMIA SRL ESTEVE QUIMICA SA LEO PHARMACEUTICAL PRODUCTS LTD II 7/10/1995 ERCROS SA A I II II I 7/13/1995 7/13/1995 7/13/1995 II 7/5/1995 PRIME EUROPEAN THERAPEUTICS SPA EUTICALS SPA ESTEVE QUIMICA SA CILAG AG BAYER SPA STATUS Type SUBMIT DATE A I A II II IV II 7/7/1995 7/4/1995 7/6/1995 7/3/1995 HOLDER TEVA PHARMACEUTICAL INDUSTRIES LTD HELSINN CHEMICALS SA LYDALL SOLUTECH BV SIGMA CHEMICAL CO SUBJECT FLUNISOLIDE ANHYDROUS MANUFACTURED IN RHO (MILAN)ITALY. MELATONIN MANUFACTURED IN BIASCA, SWITZERLAND SOLUPOR (UHWM-PE) MANUFACTURED IN HEERLEN, THE NETHERLANDS.

4Q2012

N-DODECYL B-D-MALTOSIDE (PRODUCT NO.D5795/STOCK NO. W 5309-4) MANUFACTURED A SIGMA CHEMICALS AND SIGMA DIAGNOSTICS IN ST. LOUIS, MO. KETOENAMINE MANUFACTURED IN VARESE, ITALY. KETOCONAZOLE MANUFACTURED IN CELRA (GIRONA) SPAIN. RETINAMIDIC ACID MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GARBAGNATE MILANESE ITALY. FOSFOMYCIN PHENETHYL AMMONIUM SALT MANUFACTURED IN ARANJUEZ (MADRID) SPAIN. CIMETIDINE HYDROCHLORIDE MANUFACTURED IN TRVIGLIO, ITALY. ASTEMIZOLE MANUFACTURED IN BARCELONA, SPAIN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES FOR EB 1089 EC CAPSULES IN BALLERUP, DENMARK. RETINOL 50 P MANUFACTURED IN LUDWIGSHAFEN, GERMANY. DEXAMETHASONE ACETATE USP MONOHYDRATE MANUFACTURED IN AUVERGNE, VERTOLAYE, FRANCE. MCI-154 MANUFACTURED IN IBARAKI PREFECTURE, JAPAN. PLASTIC MATERIAL FOR PLASTIC CAPS MANUFACTURED IN VAXJO, SWEDEN. ETIDRONATE DISODIUM MANUFACTURED IN MAHARASHTRA STATE AND GUJARAH, INDIA. ORG 32489 RECOMBINANT FSH MANUFACTURED IN OSS, THE NETHERLANDS. CHOLINERGIC CHANNEL ACTIVATOR-TRANSDERMAL DELIVERY SYSTEM MANUFACTURED IN ANDERNACH AND NEUWIED, FEDERAL REPUBLIC OF GERMANY. HYALURONIC ACID LMW MANUFACTURED IN OSS, THE NETHERLANDS. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES FOR BULK PROCESS DEVELOPMENT IN RODANO, ITALY. NITROGLYCERIN MANUFACTURED IN TAMAQUA, PA. BULK CRUDE PROPOFOL MANUFACTURED IN VARESE, ITALY. TRIETHYL 3-BROMOPROPANE-1, 1, 1-TRICARBOXYLATE MANUFACTURED IN CLWYD, UNITED KINGDOM. PACKAGING MATERIAL ALUMINUM FOIL SMOOTH, HARD TEMPER, .020, .025 AND .030 MM MANUFACTURED IN MANDELLO DEL LARIO-CO-ITALY. SHOLEX 6002B AND SHO-ALLOMER MA 411 AND MA 422 MANUFACTURED IN OITA PREFECTURE, JAPAN AND BY JAPAN POLYPROPYLENE CO., LTD. IN OKAYAMA PREFECTURE, JAPAN. METOPROLOL SUCCINATE MANUFACTURED IN HLOHOVEC, SLOVAKIA. CHLOROFLUOROCARBON 11, 12, AND 114. CIPROFLOXACIN HYDROCHLORIDE MANUFACTURED IN BARCELONA, SPAIN.

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4Q2012EXCEL DMF# 11603 I 11604 I 11605 11606 A 11607 11608 I 11609 I 11610 I 11611 I 11612 11613 11614 A 11615 11616 11617 11618 11619 I 11620 I 11621 11622 I 11623 I 11624 11625 I 11626 I 11627 I 11628 11629 I 11630 I II 8/15/1995 SLOVAKOFARMA LTD I IV I 8/11/1995 8/17/1995 II 6/4/1996 III 8/14/1995 I III I 8/4/1995 8/14/1995 REXENE CORP LABORATORIOS SERONO SA V 7/20/1995 PHARMACO LIFE SCIENCE RESEARCH I III V 8/7/1995 7/20/1995 HARTFORD PLASTICS PHARMACO LIFE SCIENCE RESEARCH IV 8/8/1995 CYTRX CORP A I I I II III III II II 8/4/1995 9/1/1995 8/3/1995 8/7/1995 8/9/1995 I I III III II 8/2/1995 8/2/1995 7/28/1995 KANEKA TEXAS CORP KANEKA TEXAS CORP VETTER PHARMA FERTIGUNG GMBH AND CO KG COGNIS CORP SONOCO FLEXIBLE PACKAGING DSM POLYMERS SANDOZ PHARMA LTD UNION QUIMICO FARMACEUTICA SA KANE ACE B-22, B-52, B-56, AND B-522 MANUFACTURED IN PASADENA, TEXAS. KANE ACE B-22, B-52, B-56, AND B-522 MANUFACTURED IN HYOGO, JAPAN. III 8/2/1995 KANEKA TEXAS CORP II 7/28/1995 AIR LIQUIDE AMERICA CORP II 7/25/1995 LIFECORE BIOMEDICAL INC A II III 7/31/1995 7/25/1995 I II II 7/28/1995 7/27/1995 HELSINN CHEMICALS SA SHANDONG XINHUA PHARMACEUTICAL CO LTD FARMHISPANIA SA SUPERFOS PHARMA III 7/18/1995 CARCANO ANTONIO S.P.A. STATUS Type SUBMIT DATE II 7/25/1995 HOLDER SHANGHAI INDUSTRIAL CHEMICAL CO LTD SUBJECT

4Q2012

D-(-)-PHENYGLYCINE DANE SALT MANUFACTURED IN SHANGHAI, PEOPLE'S REPUBLIC OF CHINA. PACKAGING MATERIAL ALUMINUM FOIL, SMOOTH, SOFT TEMPER, .045 AND .048MM MANUFACTURED IN MANDELLO DEL LARIO-CO-ITALY. TRAMADOL HYDROCHLORIDE MANUFACTURED IN BIASCA, SWITZERLAND. HYDROCORTISONE BASE MANUFACTURED IN ZIBO, PEOPLE'S REPUBLIC OF CHINA. ATRACURIUM BESYLATE MANUFACTURED IN BARCELONA, SPAIN. HD POLYETHYLENE COLOURED WHITE BOTTLES MANUFACTURED IN VAERLOESE, DENMARK. HY-50 HYALURONATE SODIUM STERILE INJECTION MANUFACTURED IN CHASKA, MINNESOTA. 2200 PPM NITRIC OXIDE/BALANCE NITROGEN GAS MIXTURE MANUFACTURED IN LONG BEACH, CALIFORNIA. KANE ACE B-22, B-52, B-56, AND B-522 MANUFACTURED IN WESTERLO-OEVEL, BELGIUM.

STERILE WATER FOR INJECTION MANUFACTURED IN LANGENARGEN, GERMANY EMEROX 1144 AZELAIC ACID MANUFACTURED IN CINCINNATI, OHIO. MPE953M-3 MANUFACTURED IN EDINBURGH, INDIANA. STAMYLAN LD 2304A MANUFACTURED IN BEEK, THE NETHERLANDS. CYCLOSPORINE MANFACTURED IN BASLE, SWITZERLAND. 2-ISOPROPYL-4-(N-METHYL) AMNINOMETHYLTHIAZOLE MANUFACTURED IN BARCELONA, SPAIN. CRL-1005 (POE-POP-POE BLOCK COPOLYMER 120.5) MANUFACTURED IN NORCROSS, GEORGIA. HIGH-DENSITY POLYETHYLENE MANUFACTURED IN WINDSOR, CONNECTICUT. METHOD MS23.1, GC/MS ANALYSIS OF ENALAPRIL AND ENALAPRILA IN HUMAN URINE MANUFACTURED IN RICHMOND, VIRGINIA. METHOD MS23 REVISION 1 GC/MS ANALYSIS OF ENALAPRIL AND ENALAPRILA IN HUMAN PLASMA MANUFACTURED IN RICHMOND, VIRGINIA. POLYETHYLENE RESIN PE 1403 MANUFACTURED IN ODESSA, TEXAS.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TRES CANTOS, SPAIN. SAMHWA LUBE OIL CO LTD LUBRICATION OILS FOR COLD ROLLING OF ALUMINUM FOIL MANUFACTURED IN KANGWON-PROVINCE, KOREA. FARCHEMIA SRL DIV TESSENDERLO CHEMIE NAPROXEN SODIUM USP MANUFACTURED IN TREVILGLIO (BERGAMO) ITALY HENRY H OTTENS MANUFACTURING CO INC ARTIFICIAL COOLING COMPOUND #6883 MANUFACTURED IN PHILADELPHIA, PA. DEGUSSA AG MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CISPLATIN USP IN HANAU, GERMANY. METOPROLOL TARTRATE MANUFACTURED IN HLOHOVEC, SLOVAKIA.

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4Q2012EXCEL DMF# 11631 I 11632 I 11633 I 11634 11635 I 11636 A 11637 11638 11639 11640 A 11641 11642 11643 11644 I 11645 I 11646 I 11647 11648 A 11649 11650 A 11651 11652 11653 I 11654 I 11655 I 11656 11657 11658 I I A II II III 9/18/1995 8/18/1995 9/15/1995 MAPRIMED SA ACS DOBFAR SPA I 9/15/1995 GULF PHARMACEUTICAL INUSTRIES III 9/11/1995 FOLIENWALZWERK BRUDER TEICH AG A I IV II III 1/3/1996 9/4/1995 9/13/1995 SPI PHARMA INC CELSUS LABORATORIES INC PROMEXMEDICAL INC I II II 9/12/1995 9/8/1995 JANSSEN PHARMACEUTICA NV HUASHU PHARMACEUTICAL CORP I III V 9/6/1995 9/6/1995 WEST PHARMACEUTICAL SERVICES INC WEST PHARMACEUTICAL SERVICES INC III 9/8/1995 AMPACET CORP II 9/7/1995 DSM ANDENO BV I I I II III II III 9/1/1995 8/16/1995 9/13/1995 9/5/1995 CELSUS LABORATORIES INC REXENE CORP MERCK AND CO INC 3M HEALTH CARE LTD I A A II II II III 8/28/1995 9/1/1995 8/28/1995 10/9/1995 ZENTIVA, A.S. ROCHE DIAGNOSTICS GMBH NORBROOK SRO REXAM HEALTHCARE OFFRANVILLE SAS II 8/30/1995 MALLINCKRODT INC I III II 8/7/1995 8/31/1995 I 8/25/1995 I 8/23/1995 STATUS Type SUBMIT DATE II 8/23/1995 HOLDER SUBJECT

4Q2012

SHANGHAI NUMBER 6 PHARMACEUTICAL PRAZIQUANTEL MANUFACTURED IN SHANGHAI PROVINCE, PEOPLE'S REPUBLIC OF FACTORY CHINA. TIANJIN HEBEI PHARMACEUTICAL FACTORY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TIANJIN, CHINA. CALAIRE CHIMIE SA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CEDEX, FRANCE. FLINT HILLS RESOURCES LP POLYPROPYLENE RESIN PP 6310 MANUFACTURED IN ODESSA, TEXAS. UCB INC METHYLPHENIDATE HYDROCHLORIDE, USP MANUFACTURED IN SANTA ANA, CALIFORNIA. MEPERIDINE HYDROCHLORIDE INJECTION USP 10MG/ML (ESUB) AS MANUFACTURED IN RALEIGH, NORTH CAROLINA. D,L-METIPRANOLOL MANUFACTURED IN HLOHOVEC, SLOVAKIA. D,L-METIPRANOLOL MANUFACTURED IN MANNHEIM, GERMANY PROCAINE HYDROCHLORIDE USP MANUFACTURED IN SEMTIN, CZECH REPUBLIC. PLASTIC BOTTLE 10ML PEHD WHITE, PLASTIC NOZZLE PELD WHITE, AND PLASTIC CAP PELD/HD MIXING 50/50 MANUFACTURED IN DIEPPE, FRANCE. PERIODATE-OXIDIZED HEPARIN MANUFACTURED IN CINCINNATI, OHIO. POLYPROPYLENE RESIN PP 13T10A CS-276 MANUFACTURED IN ODESSA, TEXAS. STERILE DILUENT MANUFACTURED IN WEST POINT, PENNSYLVANIA. MSX 1174P NONWOVEN TAPE MANUFACTURED IN BROOKINGS, SD AND ST. PAUL, MINNESOTA. 3,H-1,2,4-TRIAZOL-3-ONE, 5-ETHYL-2-4-DIHYDRO-4-(2-PHENOXYETHYL)TRIAZOLON MANUFACTURED IN VENLO, THE NETHERLANDS. 10061 SLIP POLYETHYLENE MASTERBATCH MANUFACTURED IN TERRE HAUTE, INDIANA, DERIDDER, LOUISIANA, CARTERSVILLE, GEORGIA AND AMPACET EUROPE, S.A., MESSANCY, BELGIUM. COUNTER CAP MANUFACTURED IN WILLIAMSPORT, PA WESTAR MANUFACTURED IN JERSEY SHORE, PA, SINGAPORE, ESCHWEILER, GERMANY, AND LE NOUVION-EN-THIERACHE, FRANCE. R093877 MANUFACTURED IN GEEL, BELGIUM. OXYTETRACYCLINE BASE MANUFACTURED IN SHIJIAZHUANG, PEOPLE'S REPUBLIC OF CHINA. SORBITOL SPECIAL (PLASTICIZER) MANUFACTURED IN NEW CASTLE, DELAWARE. DERMATAN SULFATE MANUFACTURED IN CINCINNATI, OHIO. SECONDARY PACKAGING OF ZOSTRIX CREAM .025% CAPSAICIN AND ZOSTRIX HP CREAM, .075% CAPSAICIN MANUFACTURED IN WEST CALDWELL, NEW JERSEY. LACQUERED ALUMINUM FOIL FOR PACKAGING OF CONDOMS MANUFACTURED IN OBERGRAFENDORF-MUHLHOFEN, AUSTRIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RAS AL KHAIMAH, UNITED ARAB EMIRATES. ENALAPRIL MALEATE MANUFACTURED IN BUENOS AIRES, ARGENTINA. 7-ZACA MANUFACTURED IN MILANO, ITALY.

CLARIANT CORPORATION MASTERBATCHES WLA-12486-A 25/1 WHITE ANTI-STAT COLOR CONCENTRATE MANUFACTURED IN DIVISION MCHENRY, ILLINOIS.

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4Q2012EXCEL DMF# 11659 A 11660 11661 I 11662 11663 11664 A 11665 11666 11667 11668 11669 I 11670 I 11671 I 11672 A 11673 A 11674 A 11675 I 11676 11677 I 11678 11679 I 11680 I 11681 I 11682 A 11683 11684 I 11685 11686 I I II V 4/20/1995 9/27/1995 SYNTHELABO PHARMACIE VETTER PHARMA FERTIGUNG GMBH A II III 9/25/1995 9/22/1995 COPPERHEAD INVESTMENTS INC PROMEXMEDICAL INC II 9/19/1995 ISOCHEM SA I 9/26/1995 AMOLI ORGANICS LTD I 9/27/1995 DURA PHARMACEUTICALS INC A IV II 9/13/1995 9/20/1995 FMC CORP FMC BIOPOLYMER DIV BOEHRINGER INGELHEIM PHARMA KG I II II 9/26/1995 9/25/1995 AMOLI ORGANICS LTD AJINOMOTO CO INC II 9/18/1995 II 9/22/1995 II 9/22/1995 II 9/22/1995 PRIME EUROPEAN THERAPEUTICS SPA EUTICALS SPA PRIME EUROPEAN THERAPEUTICS SPA EUTICALS SPA PRIME EUROPEAN THERAPEUTICS SPA EUTICALS SPA KURITA WATER INDUSTRIES LTD III 9/15/1995 KERPLAS SNC II 9/23/1995 UNION QUIMICO FARMACEUTICA SA I I I I II II II II II 9/15/1995 9/11/1995 9/19/1995 9/19/1995 10/2/1995 EURAND AMERICA INC FINORGA SA QUIMICA SINTETICA SA ASH STEVENS INC SIGMA CHEMICAL CO A I II II II 9/15/1995 9/20/1995 9/21/1995 TEVA PHARMACEUTICAL INDUSTRIES LTD TAKEDA CHEMICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD I IV I 9/11/1995 9/15/1995 GLIDCO INC LABORATORIOS ARGENOL SL STATUS Type SUBMIT DATE III 9/15/1995 HOLDER EASTMAN CHEMICAL CO SUBJECT

4Q2012

EASTAR POLYMERS DN003 AND DN004 AND EASTALLOY POLYMER DA003-8999K MANUFACTURED IN KINGSPORT,TENNESSEE OR COLUMBIA,SOUTH CAROLINA PEPPERMINT OIL 540 MANUFACTURED IN JACKSONVILLE, FLORIDA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ZARAGOZA, SPAIN. SILVER SULFADIAZINE MANUFACTURED IN ZARAGOZA, SPAIN. EM574 MANUFACTURED IN OSAKA, JAPAN. TICLOPIDINE HCL MANUFACTURED IN CARONOO PERTUSELLA (VARESE) AND BULCIAGO (LECCON), ITALY. MICROCAPS PSEUDOEPHEDRINE HCL MANUFACTURED IN VANDALIA, OHIO. RITONAVIR MANUFACTURED IN CHASSE SUR RHONE, FRANCE. RANITIDINE HCL FORM 1 MANUFACTURED IN MADRID, SPAIN. WR 242511 MANUFACTURED IN RIVERVIEW, MICHIGAN. POLYGALACTURONIC ACID SIGMA STOCK NUMBER (W 5356-6) MANUFACTURED BY SIGMA CHEMICALS CO. AND SIGMA DIAGONSTICS IN ST. LOUIS, MISOURI. 2-ISOPROPYL-4-(N-METHYL) AMINOMETHYLTHIAZOYLCARBONYL-(L)-VALINE MANUFACTURED IN BARCELONA, SPAIN. PLASTIC BOTTLE PEHD WHITE (20, 35, 50ML) AND PLASTIC LID PP WHITE MANUFACTURED IN DIEPPE, FRANCE. A-84538.0 (RITONAVIR) MANUFACTURED IN ORIGGIO, VARESE, ITALY. BOC CORE SUCCINATE MANUFACTURED IN ORIGGIO, VARESE, ITALY. 5-THIAZOLE WING MANUFACTURED IN ORIGGIO, VARESE, ITALY. KURIMOVER II MANUFACTURED IN KANAGAWA, JAPAN, AND BY YMC CO., LTD IN KYOTO, JAPAN. DICLOFENAC SODIUM MANUFACTURED IN GUJARAT STATE, INDIA. A-84538.0 (RITONAVIR) MANUFACTURED IN HINAGA YOKKAICHI, MIE PREFECTURE, JAPAN. MARINE COLLOIDS CARRAGEENAN MANUFACTURED IN ROCKLAND, MAINE. SCOPOLAMINE-N-BUTLYBROMIDE (BUSCOPAN) MANUFACTURED IN INGELHEIM/RHEIN, GERMANY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SAN DIEGO, CALIFORNIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GUJARA, INDIA. TERTIOBUTYL-4'-CHLORO-4-BUTYROPHENONE MANUFACTURED IN GENNEVILLIERS CEDEX, FRANCE. SDM 26 (NITROGLYCERIN ON LACTOSE MIXTURE) MANUFACTURED IN TAMAQUA, PA. SECONDARY PACKAGING OF BIAXIN FILMTABS CLAIRTHROMYCIN 500MG TABLETS, MEDISCRIPTS STARTER MANUFACTURED IN WEST CALDWELL, NEW JERSEY. UREA-CALCIUM ACETYLSALICYLATE MANUFACTURED IN AMILLY, FRANCE. PRODUCTION OF PRE-FILLED SYRINGES AND LIQUID PRODUCTS AS MFG IN RAVENSBURG, FEDERAL REPUBLIC OF GERMANY

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4Q2012EXCEL DMF# 11687 11688 11689 I 11690 I 11691 A 11692 11693 I 11694 11695 11696 11697 11698 I 11699 11700 11701 I 11702 11703 I 11704 11705 I 11706 11707 11708 I 11709 I 11710 A 11711 11712 I 11713 A 11714 I 11715 I III 10/18/1995 MAC CLOSURES INC II 10/18/1995 V 10/20/1995 A III III 9/27/1995 10/16/1995 TRIVENI POLYMERS PRIVATE LTD CLARIANT CORPORATION MASTERBATCHES DIVISION AMERICAN PHARMACEUTICAL PARTNERS INC BOEHRINGER INGELHEIM PHARMA KG III 10/10/1995 TUBED PRODUCTS LLC II 10/2/1995 A A II III III 10/12/1995 10/13/1995 10/11/1995 BAYER SCHERING PHARMA AG 3M DRUG DELIVERY SYSTEMS CLARIANT CORPORATION MASTERBATCHES DIVISION TERRY MESON TECHNOLOGY LTC A II II 10/5/1995 10/4/1995 EXCELLA GMBH AVECIA INC A II I 10/10/1995 10/6/1995 DR REDDYS LABORATORIES LTD CLINETICS CORP I I II II I 10/4/1995 9/30/1995 9/28/1995 SIMS FARCHEMIA SRL PHARMACIA AND UPJOHN INC I I I I III II IV II III 10/4/1995 9/28/1995 9/28/1995 10/3/1995 10/5/1995 COVALENCE COATED PRODUCTS AIR PRODUCTS AND CHEMICALS INC GATTEFOSSE SA JACOBUS PHARMACEUTICAL CO YOSHINO KOUGYOUSHO CO LTD A II I 10/3/1995 9/29/1995 CAMBREX PROFARMACO MILANO SRL ALMEDICA EUROPE LTD III 9/29/1995 BAXTER HEALTHCARE CORP III 9/29/1995 CREST FLEXIBLE PACKAGING LTD STATUS Type SUBMIT DATE A I III II V 9/18/1995 9/29/1995 9/12/1995 HOLDER AMILCO SA DELMAR CHEMICALS INC EORTC NEW DRUG DEVELOPMENT OFFICE SUBJECT GLASS TUBULAR CONTAINERS MANUFACTURED IN MADRID, SPAIN. KETOROLAC DERIVAIVE MANUFACTURED IN LASALLE, QUEBEC, CANADA.

4Q2012

STANDARD OPERATING PROCEDURES OF EARLY CLINICAL RESEARCH OF NEW ANTICANCER AGENTS. PACKAGING MATERIALS FOR MEDICAL PACKAGING (PAPER/PE/FOIL/MEL 850 45.0G/M2 PAPER) MANUFACTURED IN KENT, ENGLAND. TERMINALLY STERILIZED INJECTIONS IN PL 2408 PLASTIC CONTAINER MANUFACTURED IN MARION, NORTH CAROLINA. CLOZAPINE MANUFACTURED IN PAULLO (MILANO) ITALY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DEESIDE, UNITED KINGDOM. 41706-40 MANUFACTURED IN COLUMBUS, GEORGIA. APF-N30 (PERFLUOROPROPANE) MANUFACTURED IN ALLENTOWN, PENNSYLVANIA. PLUROL DIISOSTEARIQUE MANUFACTURED IN SAINT-PRIEST CEDEX, FRANCE. AMINOSALICYLATE SODIUM USP MANUFACTURED IN PLAINSBORO, NEW JERSEY. PLASTIC CONTAINER FOR WRAPPING TABLETS MANUFACTURED IN TOCHIGI-KEN AND GUNMA-KEN, JAPAN. FLUOXETINE HCL MANUFACTURED IN REGGELLO (FLORENCE) ITALY. DICLOFENAC SODIUM MANUFACTURED IN TREVIGLIO (BERGAMO) ITALY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN NERVIANO MILAN, ITALY. PERMETHRIN MANUFACTURED IN WEST YORKSHIRE, ENGLAND. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TUSTIN, CALIFORNIA. METHOTREXATE (ESUB) MANUFACTURED IN FEUCHT, GERMANY. SDM-79 (25% NITROGLYCERIN IN SOLVATED ADHESIVE POLYMER) MANUFACTURED IN TAMAQUA, PA. ILOPROST B-CYCLODEXRIN CLATHRATE MANUFACTURED IN BERLIN, GERMANY. A66210 SPRAYMISER MK2 VALVE MANUFACTURED IN LANCASHIRE, GREAT BRITAIN. MLC-15194 25/1 SILVER METALLIC COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS. STRONTIUM-82 (P:4N, 6N) MANUFACTURED IN TROITSK, MOSCOW, RUSSIA AND BY CYCLOTRON (INSTITUTE FOR PHYSICS AND POWER ENGINNERING) IN OBNINSK, KALUGA, RUSSIA. POLYETHYLENE AND POLYPROPYLENE SQUEEZE TUBES IN NUATURAL OR WHITE RESIN MANUFACTURED IN EASTHAMPTON, MASSACHUSETTS. PLASTIC CONTAINERS MANUFACTURED IN NEW DELHI, INDIA. YLC-15218 25/1 PEARL YELLOW COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS. POWDER DRUGS IN VIALS STERILIZATION PROCESS VALIDATION DOCUMENTATION (ASEPTIC FILL) IN GRAND ISLAND, NEW YORK. CAMPTOTHECIN MANUFACTURED BY BOEHRINGER INGELHEIM ESPANA, S.A. IN FABRICA MALGRATE DE MAR, SPAIN. 13-425 LINERLESS CLOSURE MANUFACTURED IN WATERLOO, QUEBEC, CANADA.

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4Q2012EXCEL DMF# 11716 I 11717 I 11718 I 11719 I 11720 I 11721 I 11722 11723 11724 11725 11726 I 11727 A 11728 11729 I 11730 I 11731 11732 11733 11734 I 11735 I 11736 I 11737 A 11738 I 11739 I 11740 11741 11742 11743 11744 I I A I A II III II II II 11/6/1995 11/8/1995 11/14/1995 11/9/1995 11/14/1995 CHEMI SPA MITSUI CHEMICALS INC TEVA PHARMACEUTICAL INDUSTRIES LTD SIGMA CHEMICAL CO DSM ANDENO BV III 10/31/1995 PECHINEY EMBALLACE ALIMENTAIRE III 11/2/1995 3M PHARMACEUTICALS INC III 11/3/1995 II 11/3/1995 ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV 3M DRUG DELIVERY SYSTEMS I 10/20/1995 LABORATOIRES SANDOZ SA A A A III III III II 10/31/1995 10/31/1995 11/1/1995 11/16/1995 REXAM HEALTHCARE PACKAGING INC 3M DRUG DELIVERY SYSTEMS 3M DRUG DELIVERY SYSTEMS MEDEA RESEARCH LABORATORIES INC II 10/26/1995 LONZA LTD A II I 1/30/1996 9/1/1995 II 10/31/1995 A I I I III III II II IV 10/16/1995 10/16/1995 10/26/1995 10/27/1995 10/27/1995 I 10/20/1995 NOVARTIS PHARMACEUTICALS CORPORATION COLORS FOR PLASTICS COLORS FOR PLASTICS LIPHA SA MERCIAN CORP MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURE IN ORLEANS-LA SOURCE, FRANCE. R27188 MANUFACTURED IN ELK GROVE VILLAGE, ILLINOIS. W06221 MANUFACTURED IN ELK GROVE VILLAGE, ILLINOIS. CROMOLYN SODIUM MANUFACTURED IN PITHIVIERS, FRANCE. RAPAMYCIN CRUDE OIL MANUFACTURED IN SHIZUOKA, JAPAN. III 10/30/1995 IV 10/16/1995 IV 10/16/1995 IV 10/16/1995 TECHNOLOGY FLAVORS & FRAGRANCES INC TECHNOLOGY FLAVORS & FRAGRANCES INC TECHNOLOGY FLAVORS & FRAGRANCES INC TENAX CORP STATUS Type SUBMIT DATE III 10/16/1995 HOLDER AIR PRODUCTS AND CHEMICALS INC SUBJECT

4Q2012

FLEXCRYL GP5 EMULSION MANUFACTURED IN PIEDMONT AND LANGLEY, SOUTH CAROLINA. ARTIFICIAL STRAWBERRY FLAVOR 844-149 MANUFACTURED IN AMITYVILLE, NEW YORK. NATURAL CHERRY WONF 544-412 MANUFACTURED IN AMITYVILLE, NEW YORK. NATURAL CHERRY TYPE FLAVOR 544-411 MANUFACTURED IN AMITYVILLE, NEW YORK. RECTAL DELIVERY SYSTEM COMPONENT MANUFACTURED IN DANBURY, CONNECTICUT.

WESTERN FLAVORS AND FRAGRANCES INC CHERRY FLAVOR ARTIFICIAL WILD W.S. #501237 MANUFACTURED IN LIVERMORE, CALIFORNIA. KOEI CHEMICAL CO LTD (S)-3-[[(1,1-DIMETHYLETHYL) AMINO] CARBONYL] -1- PIPERAZINECARBOXYLIC ACID 1,1DIMETHYLETHYL ESTER MANUFACTURED IN OSAKA, JAPAN. TAMA KAGAKU KOGYO CO LTD (-)-CIS-1-AMINOINDAN-2-01 MANUFACTURED IN SAITAMA, JAPAN. CAULDRON INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MALVERN, PENNSYLVANIA. TERT-BUTYL (S)-3-(TERT-BUTYLCARBAMOYL) PIPERAZINE-1-CARBOXYLATE MANUFACTURED IN VISP, SWITZERLAND. PLASTIC CONTAINERS MANUFACTURED IN WASHINGTON, NEW JERSEY. ALUMINIUM CAN MANUFACTURED IN LANCASHIRE, GREAT BRITAIN. A66139 50UL SPRAYMISER VALVE MANUFACTURED IN LANCASHIRE, GREAT BRITAIN. 2,5-DIMETHOXY-2-METHYL-5H-DIHYDROFURAN MANUFACTURED IN PORT JEFFERSON STATION, NEW YORK. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RUEIL-MALMAISON, FRANCE. KETOROLAC TROMETHAMINE MANUFACTURED IN NORTH CHICAGO, ILLINOIS. 3M SCOTCH PAK 9724 POLYESTER FILM LAMINATE MANUFACTURED IN COTTAGE GROVE, MINNESOTA. 66203 63UL SPRAYMISER MK1 VALVE MANUFACTURED IN LANCASHIRE, GREAT BRITAIN. BLISTER FOIL A LACQURED ANNEALED ALUMINIUM FOIL MANUFACTURED IN BRIGNOUD CEDEX, FRANCE. ETODOLAC MANUFACTURED IN PATRICIA (FROSINONE) ITALY. HZ 5195B AND MIRASON 50 MANUFACTURED IN CHIBA, JAPAN. ATRACURIUM BESYLATE MANUFACTURED IN RHO (MILAN) ITALY. CHOLESTERYL ACETATE (W 5388-4) MANUFACTURED IN ST. LOUIS, MISSOURI. (-)-CIS-1-AMINOINDAN-2-OL(AMINDA) MANUFACTURED IN VENLO, THE NETHERLANDS.

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4Q2012EXCEL DMF# 11745 I 11746 II 11/14/1995 STATUS Type SUBMIT DATE II 11/9/1995 HOLDER MORTON INTERNATIONAL INC SPECIALTY CHEMICAL GROUP PHARM ECO LABORATORIES INC SUBJECT

4Q2012

MAGNESIUM OXIDE USP HEAVY (PRODUCT CODE 6010-9)MANUFACTURED IN MANISTEE, MICHIGAN. (S)-N-BENZYL-N-[1,5,-BIS(4-PYRIDYL)-3-PENTYL]-3-(4CHLOROPHENYL)-2-{METHYL-[2-OXO2-(3,4,5 TRIMETHOXYPHENYL) ACETYL]AMINO} PROPIONAMIDE DIMETHANESULONATE MANUFACTURED IN LEXINGTON AND NORTH ANDOVER , MASSACHUSETTS. ZALEPLON MANUFACTURED IN ALMISANO DI LONIGO (VICENZA) ITALY OXAPROZIN MANUFACTURED IN GIFU PREFECTURE, JAPAN. BULK MEPERIDINE HYDROCHLORIDE USP (PETHIDINE HYDROCHLORIDE EP) DRUG SUBSTANCE MANUFACTURED IN FRANKFURT, (MAIN) FEDERAL REPUBLIC OF GERMANY. RIFAMYCIN-S MANUFACTURED IN ANSAN-CITY, KYEONGKI-DO, KOREA. CONTAINER CLOSURE COMPONENTS FOR HFA-13A METERED DOSE INHALERS (MDI), MANUFACTURED IN GREAT BRITAIN, FINLAND, LEXINGTON, KENTUCKY PLASTIC CONTAINERS MANUFACTURED IN MILLVILLE, NEW JERSEY. PREADD SL 101 MANUFACTURED IN RAJAMAKI, FINLAND. LUPOLEN 5021 D MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY. FENBENDAZOLE MANUFACTURED IN GUJARA, INDIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KYEONGKI-DO, KOREA. CEPHAPIRIN ACID MANUFACTURED IN MILANO, ITALY. METHACHOLINE CHLORIDE USP MANUFACTURED IN ONTARIO, CANADA. EMESDASTINE DIFUMARATE MANUFACTURED IN OSAKA, JAPAN. OP 3300/15 MANUFACTURED IN ORIGGIO, VARESE, ITALY. TAMSULOSIN HYDROCHLORIDE MANUFACTURED IN IBARAKI-KEN, JAPAN. SECONDARY PACKAGING OF PREVACID 15MG & 30MG CAPSULES OF LANSOPRAZOLE, MEDISCRIPTS STARTER MANUFACTURED IN WEST CALDWELL, NEW JERSEY. BK 600 SERIES PHARMACEUTICAL ORAL ACTUATOR AND DUSTCAPS MANUFACTURED IN NORFOLK, ENGLAND. ZOLPIDEM TARTRATE MODIFIED SYNTHESIS MANUFACTURED IN MOURENX, FRANCE. CONTINUOUS THREADED CLOSURES (CTC) MANUFACTURED IN QUEBEC, CANADA. ETODOLAC MANUFACTURED IN NETANYA, ISRAEL. BENZOCAINE USP MANUFACTURED IN SEMTIN, CZECH REPUBLIC. CISAPRIDE DRUG SUBSTANCE MANUFACTURED IN GEEL, BELGIUM. DISODIUM 1-MERCAPTO-UNDECAHYDRODODECABORATE, 10B-ERICHED AND 1MERCAPTO-UNDECAHYDRODODECABORATE, NATURAL ABUNDANCE MANUFACTURED IN RALEIGH, NORTH CAROLINA. FRAGRANCE CE-26101 MANUFACTURED IN SOMERSET, NEW JERSEY. COLCHICINE MANUFACTURED IN HARYANA, INDIA. SABIC LDPE 2308A MANUFACTURED IN BEEK, THE NETHERLANDS. SABIC LDPE 1922T MANUFACTURED IN BEEK, THE NETHERLANDS. STAMYLEX 9089 MANUFACTURED IN BEEK, THE NETHERLANDS.

I 11747 11748 11749 I 11750 11751 A 11752 11753 11754 11755 11756 I 11757 11758 11759 11760 11761 11762 I 11763 A 11764 11765 11766 11767 11768 11769 I 11770 11771 11772 11773 11774 I I I A I IV II III III III 11/30/1995 12/12/1995 12/15/1995 12/15/1995 12/15/1995 CUSTOM ESSENCE INC SM ORGANICS PRIVATE LTD SABIC PETROCHEMICALS BV SABIC PETROCHEMICALS BV DSM POLYMERS A A A A A II III II II II II 12/5/1995 12/4/1995 12/11/1995 12/6/1995 12/7/1995 12/5/1995 FINORGA SAS MAC CLOSURES INC TEVA PHARMACEUTICAL INDUSTRIES LTD NORBROOK SRO JANSSEN PHARMACEUTICA NV BORON BIOLOGICALS INC III 11/23/1995 BESPAK DIV CONSORT MEDICAL PLC A A A I A II II II II II III 11/9/1995 11/28/1995 11/29/1995 11/28/1995 12/1/1995 11/27/1995 ACS DOBFAR SPA APOTEX PHARMACHEM INC MSD KK ARCHIMICA SPA ASTELLAS PHARMA INC PROMEXMEDICAL INC I I I I III III III II I 11/20/1995 11/14/1995 11/14/1995 11/27/1995 11/16/1995 WHEATON WORLDWIDE INC OY PREMIX LTD BASELL POLIOLEFINE ITALIA SPA ALDRICH PHARMACEUTICALS LTD CHONG KUN DANG CORP A II III 11/16/1995 8/15/1996 CKD BIO CORP 3M PHARMACEUTICALS SBC A I II II II 11/13/1995 11/20/1995 11/17/1995 ZACH SYSTEM SPA SUMITOMO CHEMICAL CO LTD HOECHST AG

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4Q2012EXCEL DMF# 11775 11776 I 11777 11778 I 11779 A 11780 11781 11782 I 11783 11784 11785 11786 11787 11788 11789 11790 I 11791 I 11792 11793 A 11794 11795 A 11796 11797 A 11798 11799 11800 11801 11802 I 11803 11804 11805 11806 I A I I II III II I 12/19/1995 1/10/1996 1/11/1996 1/15/1996 QUIMICA SINTETICA SA 3M PHARMACEUTICALS INC ORSYMONDE I I I A IV II IV II II 12/29/1995 1/4/1996 12/21/1995 1/10/1996 1/5/1996 MISSISSIPPI BLENDING CO INC CILAG AG SENN CHEMICALS AG KYOWA HAKKO KIRIN CO LTD INHALE THERAPEUTICS SYSTEMS I II IV 1/22/1996 10/27/1995 DIASPA SPA JRS PHARMA LP A II III 12/21/1995 12/27/1995 ESTEVE QUIMICA SA TAISEI KAKO CO LTD I III III 12/18/1995 12/18/1995 SOLVAY SA SCHOTT FORMA VITRUM KFT III 12/18/1995 SOLVAY SA I A A A I I I III II II II III III III III 12/20/1995 12/20/1995 12/18/1995 12/24/1995 12/7/1995 12/18/1995 12/18/1995 12/18/1995 FLINT HILLS RESOURCES LP FIS FABBRICA ITALIANA SINTETICI SPA SANOFI AVENTIS DEUTSCHLAND GMBH KATWIJK CHEMIE BV BASELL POLIOLEFINE ITALIA SPA SOLVAY SA SOLVAY SA SOLVAY SA A I II II I 12/24/1995 12/19/1995 12/26/1995 KATWIJK CHEMIE BV WYCKOFF CHEMICAL CO INC CHISSO CORP PEMOLINE MANUFACTURED IN KATWIJK, THE NETHERLANDS. BUTAMBEN USP MANUFACTURED IN SOUTH HAVEN, MICHIGAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MINAMAA, JAPAN. POLYPROPYLENE RESIN PP 12N25A MANUFACTURED IN ODESSA, TEXAS. ESTAZOLAM MANUFACTURED IN VINCENZA, ITALY. FUROSEMIDE (BULK) MANUFACTURED IN FRANKFURT (MAIN), GERMANY. SODIUM VALPROATE MANUFACTURED IN KATWIJK, THE NETHERLANDS. II 12/22/1995 SIFAVITOR SRL A II III 12/8/1995 12/11/1995 ALBEMARLE CORP VERATEC CANADA STATUS Type SUBMIT DATE I III IV 12/15/1995 11/28/1995 HOLDER DSM POLYMERS GRAIN PROCESSING CORP SUBJECT STAMYLAN HD 9089U MANUFACTURED IN BEEK, THE NETHERLANDS.

4Q2012

SUPERABSORBENT ADDITIVES USED IN DRUG DOSAGE FORMS MANUFACTURED IN MUSCATINE, IOWA. PROPOFOL MANUFACTURED IN ORANGEBURG,SOUTH CAROLINA RAYON AND COTTON PHARMACEUTICAL COIL MANUFACTURED IN ONTARIO, CANADA. LABETALOL HYDROCHLORIDE MANUFACTURED IN FRAZIONE MAIRANO (MILANO) ITALY.

LUPOLEN 5031 L MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY. POLYPROPYLENE ELTEX P HF100 MANUFACTURED IN SARRALBE, FRANCE. B55-20N0047 MANUFACTURED IN ANTWERPEN, BELGIUM. HIGH DENSITY POLYETHYLENE ELTEX B3015LG MANUFACTURED IN SARRALBE, FRANCE. HIGH DENSITY POLYETHYLENE ELTEX B4020LG MANUFACTURED IN SARRALBE, FRANCE AND ROSIGNANO, ITALY. HIGH DENSITY POLYETHYLENE ELTEX A4009MANUFACTURED IN ROSIGNANO, ITALY. PRIMARY PACKAGING MATERIAL (VIALS, AMPULS, SYRINGES, CARTRIDGES) MANUFACTURED IN LUKACSHAZA HUNGARY OMEPRAZOLE MANUFACTURED IN CELRA (GIRONA) SPAIN. PLASTIC AND METAL TUBES FOR NONPARENTERAL CONTAINERS MANUFACTURED IN OSAKA AND KANAGAWA, JAPAN. RIFAMYCIN S BULK MANUFACTURED IN CORANA (PAVIA) ITALY. NONPAREILS (SUGAR SPHERES NF) MANUFACTURED IN ROBBINSVILLE, NEW JERSEY FOR JRS PHARMA LP. DIRECTO PRESS NF (CORNSTARCH BLEND) MANUFACTURED IN KEOKUK, IOWA. KETOROLAC TROMETHAMINE MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND. AA-D-TREHALOSE DIHYDRATE MANUFACTURED IN DIELSDORF, SWITZERLAND. OLOPATADINE HYDROCHLORIDE (KW 4679) MANUFACTURED IN OSAKA, JAPAN. DRY POWDER AEROSOL PARAHYROID HORMONE (PTH) DRUG PRODUCT MANUFACTURED IN PALO ALTO, CALIFORNIA. LORATADINE MANUFACTURED IN MADRID, SPAIN. A66154 50UL SPRAYMISER VALVE MANUFACTURED IN LANCASHIRE, GREAT BRITAIN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF MODAFINIL DRUG SUBSTANCE IN MITRY-MORY MITRY-MORY CEDEX FRANCE. Page 340

SMITHKLINE BEECHAM PHARMACEUTICALS CIMETIDINE MANUFACTURED IN CAMACARI-BAHIA, BRAZIL.

4Q2012EXCEL DMF# 11807 11808 11809 A 11810 A 11811 11812 I 11813 I 11814 11815 I 11816 I 11817 11818 I 11819 11820 A 11821 11822 I 11823 11824 I 11825 11826 11827 I 11828 11829 11830 I 11831 11832 I 11833 I 11834 A II 1/29/1996 CHEMI SPA IV 1/19/1996 COURTAULDS CHEMICALS I II I 1/19/1996 1/19/1996 A I II II II 1/26/1996 1/24/1996 1/24/1996 FARCHEMIA SRL FIDIA FARMACEUTICI SPA I A II II II 1/24/1996 1/3/1996 1/25/1996 PTI ADVANCED FILTRATION INC NV ORGANON CHEMICA A II II 1/23/1996 1/25/1996 A II I 1/23/1996 1/15/1996 A IV III 1/17/1996 12/22/1995 MITSUI CHEMICALS INC SCHOTT AG PHARMACEUTICAL SYSTEMS MULLHEIM SANOFI CHIMIE A III I 1/18/1996 1/17/1996 APTAR FRANCE SAS MITSUI CHEMICALS INC II 1/12/1996 SIGMA CHEMICAL CO I II IV 1/17/1996 12/20/1995 JANSSEN PHARMACEUTICA NV DAVID MICHAEL AND CO INC IV 1/15/1996 TIMERX TECHNOLOGIES A II III 1/15/1996 1/11/1996 CIPLA LTD CARCANO ANTONIO S.P.A. II 1/16/1996 CHENG FONG CHEMICAL CO LTD STATUS Type SUBMIT DATE A A II II II 1/15/1996 1/9/1996 1/15/1996 HOLDER FARCHEMIA SRL INTERQUIM SA ACS DOBFAR SPA SUBJECT MESALAMINE MANUFACTURED IN TREVIGLIO (BERGAMO) ITALY. SERTACONAZOLE NITRATE MANUFACTURED IN BARCELONA, SPAIN.

4Q2012

TRISODIUM CITRATE DIHYDRATE (STERILE) MANUFACTURED IN TRIBIANO MILANO, ITALY. PHENYLPROPANOLAMINE HYDROCHLORIDE MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA. NORFLOXACIN USP (ESUB) MANUFACTURED IN KURKUMBH, INDIA. ALUMINIUM FOIL, SMOOTH, HARD TEMPER, .020 AND .025 MM LACQUERED MANUFACTURED IN MANDELLO DEL LARIO-CO-ITALY. TIMERX-O CONTROLLED RELEASE SYSTEM MANUFACTURED BY BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. AND GLAXO WELLCOME INC. IN DANBURY, CONNECTICUT AND QUEBEC, CANADA. RIDOGREL DRUG SUBSTANCE MANUFACTURED IN GEEL, BELGIUM. MICHAELOK NATURAL LEMON-LIME FLAVOR WONF #1296 MANUFACTURED IN PHILADELPHIA, PENNSYLVANIA. CHOLESTERYL BENZOATE, STOCK NUMBER W 5389-2 MANUFACTURED BY SIGMA CHEMICAL AND SIGMA DIAGNOSTICS IN ST. LOUIS, MISSOURI. METERED DOSE VALVES MANUFACTURED BY APTAR IN LE VAUDREUIL, FRANCE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF PLGA5 IN NAGOYA, JAPAN. PLGA5, POLY 9DL-LACTIDE-O(O-GLYCOLIDE), MANUFACTURED IN NAGOYA, JAPAN. GLASS VIALS MANUFACTURED IN MULLHEIM, GERMANY. TILUDRONATE DISODIUM DRUG SUBSTANCE MANUFACTURED IN ARAMON, FRANCE.

RANQ PHARMACEUTICALS AND EXCIPIENTS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PVT LTD PROCEDURES IN MAHARASHTRA STATE INDIA. ACS DOBFAR SPA CEFOXITIN ACID MANUFACTURED IN MILANO, ITALY. HOECHST MARION ROUSSEL INC RANITIDINE HYDROCHLORIDE USP, FORM 1 MANUFACTURED BY DOW CHEMICAL COMPANY IN MIDLAND, MICHIGAN. CLARIFLOW PRODUCT LINE MANUFACTURED IN NEWBURY PARK, CALIFORNIA. TESTOSTERONE MANUFACTURED IN OSS, THE NETHERLANDS. A-PHENYL-A-(2-PYRIDYL) ACETIC ACID METHYL ESTER MANUFACTURED IN LOS ANGELES, CALIFORNIA. NAPROXEN USP MANUFACTURED IN TREVIGLIO (BERGAMO) ITALY. ACYCLOVIR SODIUM SALT MANUFACTURED IN MULAZZANO (MI), ITALY.

LOS ALAMOS NATIONAL LABORATORY DEPT CU-67 BULK RADIOISOTOPIC PRODUCT MANUFACTURED IN LOS ALAMOS, NEW MEXICO. ENERGY VEREIN FUR KREBSFORSCHUNG ISCADOR QU SPEZIAL MANUFACTURED IN ARLESHEIM, SWITZERLAND. VEREIN FUR KREBSFORSCHUNG MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF ISCADOR QU SPEZIAL IN ARLESHEIM, SWITZERLAND. SEPA 0009 (2-MONYL-1,3-DIOXACYCLOPENTANE) MANUFACTURED IN SCOTLAND, UNITED KINGDOM. BUPROPION HYDROCHLORIDE MANUFACTURED IN PATRICA (FROSINONE) ITALY.

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4Q2012EXCEL DMF# 11835 I 11836 11837 A 11838 11839 I 11840 I 11841 11842 11843 I 11844 I 11845 11846 11847 11848 11849 I 11850 I 11851 11852 I 11853 I 11854 11855 11856 I 11857 11858 I 11859 A 11860 11861 11862 I I I II III II 2/19/1996 2/26/1996 2/8/1996 TASMANIAN ALKALOIDS PARTY LTD GRAND POLYMER CO LTD MEDICHEM SA IV 2/16/1996 I II III 2/9/1996 2/14/1996 WOODWARD IODINE CORP CLARIANT CORPORATION MASTERBATCHES DIVISION MERCK SHARP AND DOHME CORP I I IV IV II 2/13/1996 2/13/1996 2/19/1996 SYMRISE INC SYMRISE INC BIOSEPRA SA I 3/4/1996 A III III 2/16/1996 2/14/1996 BERRY PLASTICS CORP CLARIANT CORPORATION MASTERBATCHES DIVISION SEPPIC DIV AIR LIQUIDE I 2/5/1996 CIBA GEIGY CORP PHARMACEUTICALS DIV I I I A II IV II II II 2/6/1996 2/5/1996 2/8/1996 2/8/1996 2/13/1996 NISSAN CHEMICAL INDUSTRIES LTD EASTMAN CHEMICAL CO NORDION INTERNATIONAL INC PFIZER INC PHARM ECO LABORATORIES INC III 10/12/1995 POLIMERI EUROPA I I II II II 1/29/1996 1/26/1996 2/5/1996 NAPRO BIOTHERAPEUTICS INC ARCHIMICA SPA EURAND INTERNATIONAL SPA I 1/15/1996 COVANCE PHARMACEUTICAL PACKAGING SERVICES INC I II II 1/30/1996 1/17/1996 YAMAKAWA CHEMICAL INDUSTRY CO LTD GENPHARM INC I II III 1/29/1996 1/18/1996 ASAHI GLASS CO LTD AMPACET CORP STATUS Type SUBMIT DATE I 1/29/1996 HOLDER ASAHI GLASS CO LTD SUBJECT

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF BFBB MANUFACTURED BY SEIMI CHEMICAL CO., LTD. IN KANAGAWA, JAPAN. BFBB MANUFACTURED BY SEIMI CHEMICAL CO., LTD. IN KANAGAWA, JAPAN. 19571 BLACK POLYETHYLENE MASTERBACH MANUFACTURED IN TERRE HAUTE, INDIANA, DERIDDER, LOUISIANA, CARTERSVILLE, GEORGIA OR BY AMPACET EUROPE S.A., IN MESSANCY, BELGIUM. BOC-PIPERAZINE MANUFACTURED IN IBARAKI, JAPAN. RANITIDINE HYDROCHLORIDE USP FORM 1 MANUFACTURED IN LLICA DE VALL AND SAINT CELONI BARCELONA, SPAIN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF PACKAGING OF CLILNICAL TRIALS SUPPLIES IN BASEL, SWITZERLAND. PACLITAXEL DRUG SUBSTANCE MANUFACTURED IN BRITISH COLUMBIA, CANADA. SANCYCLINE MANUFACTURED IN ORIGGIO VARESE, ITALY. DIFFUCAPS PSEUDOEPHEDRINE HCL BULK PELLETS MANUFACTURED IN CINISELLO BALSAMO (MI) ITALY. GREENFLEX FF 55 M (MEDICAL GRADE) MANUFACTURED BY POLIMERI EUROPA GMBH IN OBERHAUSEN, GERMANY. ALPROSTADIL MANUFACTURED IN YAMAGUCHI, JAPAN. DIETHYL PHTHALATE, NF MANUFACTURED IN KINGSPORT, TENNESSEE. DOPASCAN INJECTION MANUFACTURED IN VANCOVER, B.C. CANADA. BETAMETHYL EPOXIDE MANUFACTURED IN KALAMAZOO, MICHIGAN. 2(R)-HYDROXY-3(S) BOC-AMINO-4-PHENYL-1-AMINOBUTANE MANUFACTURED IN NORTH ANDOVER, MASSACHUSETTS. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES BY CIBA-GEIGY SPA IN TORRE ANNUNIAA (NAPLES) ITALY. 41121-22 MANUFACTURED IN COLUMBUS, GEORGIA. GLC-16004 25/1 LIME COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GIVAUDAN LAVIROTTE, LYON, FRANCE. CHERRY FLAVORING 9/021529 MANUFACTURED IN HOLZMINDEN, GERMANY. CHERRY FLAVORING 9/021935 MANUFACTURED IN HOLZMINDEN, GERMANY. CM-HYPERD (10U, 20U, F AND M GRADES) MANUFACTURED IN VILLENEUVE-LA GARENNE, FRANCE. IODINE (USP IODINE) MANUFACTURED IN WOODWARD, OKLAHOMA. BLC-16005 25/1 PEARL BLUE COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS. POLYVINYL ACETATE-CROTONIC ACID COPOLYMER MANUFACTURED IN EAST PALO ALTO, CALIFORNIA. FOR MERCK AND CO INC BUPRENORPHINE BASE MANUFACTURED IN TASMANIA, AUSTRALIA. GRANDPOLYPRO F300(I) AND F305(I) MANUFACTURED IN CHIBA, JAPAN. OXAPROZIN MANUFACTURED IN CELRA (GERONA) SPAIN.

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4Q2012EXCEL DMF# 11863 11864 I 11865 I 11866 11867 11868 A 11869 I 11870 11871 A 11872 11873 I 11874 I 11875 I 11876 11877 11878 I 11879 A 11880 11881 A 11882 11883 11884 11885 11886 I 11887 11888 11889 11890 11891 I I A A I II II II II II 3/6/1996 3/8/1996 3/11/1996 2/22/1996 2/28/1996 IROTEC LABORATORIES SIGMA ALDRICH IRELAND LTD OMICRON QUIMICA SA ISOCHEM SA I I I I II II IV II II 3/13/1996 3/8/1996 3/4/1996 2/28/1996 2/28/1996 ORION CORP FERMION EAGLE PICHER INDUSTRIES INC MYLAN TECHNOLOGIES INC UCB SA PHARMACEUTIQUE SECTEUR UCB SA PHARMA SECTOR I III III 3/5/1996 3/5/1996 TUBEX LTD IRELAND AMCOR FLEXIBLES BURGDORF GMBH II 2/29/1996 MICROBIOPHARM JAPAN CO LTD A A II II V 2/28/1996 3/4/1996 2/27/1996 BK GIULINI GMBH CILAG AG MCGAW INC IV 2/28/1996 I 2/28/1996 I III III 2/19/1996 2/27/1996 MITSUI CHEMICALS INC B BRAUN MEDICAL INC A III III 2/29/1996 2/28/1996 BERRY PLASTICS CORP DESICCARE INC I 2/21/1996 PLASRO PLASTICS LTD A I II II IV 2/27/1996 2/28/1996 2/27/1996 ESTEVE QUIMICA SA CILAG AG ENDO PHARMACEUTICALS INC I 2/19/1996 DUDEK PLAST AS STATUS Type SUBMIT DATE I II II 2/14/1996 1/1/1996 HOLDER BROOKHAVEN NATIONAL LAB DSM DERETIL SUBJECT

4Q2012

CU-67 BULK RADIOISOTOPIC PRODUCT MANUFACTURED IN UPTON, NEW YORK. D-(-) ALPHA PHENYLGLYCINE CHLORIDE HYDROCHLORIDE MANUFACTURED IN ALMERIA, SPAIN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN JONSTRUP, DENMARK. ENALAPRIL MALEATE MANUFACTURED IN BARCELONA, SPAIN. OXAPROZIN MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND. TIMERX CONTROLLED RELEASE SYSTEMS MANUFACTURED IN KIRKLAND, QUEBEC, CANADA FOR PENWEST PHARMACEUTICALS CO MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SURREY, UNITED KINGDOM. 41708-34 MANUFACTURED IN COLUMBUS, GEORGIA. PACKAGING MATERIALS PILLOW PAKS MANUFACTURED IN SANTA FE SPRINGS, CALIFORNIA. MIRASON 14P MANUFACTURED IN CHIBA, JAPAN.

QUALIFICATION AND MANUFACTURING OF EXCEL PLASTIC IV CONTAINER MANUFACTURED IN IRVINE, CALIFORNIA. BOEHRINGER MANNHEIM SA MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BARCELONA, SPAIN. MARUTI INDUSTRIAL CARBOHYDRATES LTD MICROCRYSTALLINE CELLULOSE (MCC) MANUFAURED IN TAMILNADU, INDIA. SUCRALFATE POWDER MANUFACTURED IN LUDWIGSHAFEN/RHEIN, GERMANY. ARTICAINE HYDROCHLORIDE MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND. STERILIZATION AND MICROBIOLOGY PROGRAM FOR EXCEL PLASTIC IV CONTAINER MANUFACTURED IN IRVINE, CALIFORNIA. DAUNORUBICIN HYDROCHLORIDE (CRUDE) MANUFACTURED IN KUMAMOTO AND SHIZUOKA, JAPAN. COLLAPSIBLE ALUMINIUM TUBES MANUFACTURED IN TIPPERARY, IRELAND. COMPOUND PACKAGING MATERIAL PAPER/OPA/ALUMINIUM/PAN-BAREX MATERIAL #SOP 50963 MANUFACTURED IN BURGDORF, SWITZERLAND. TERAZOSIN HYDROCHLORIDE DIHYDRATE MANUFACTURED IN ESPOO, FINLAND. CEP-2563 DIHYDROCHLORIDE MANUFACTURED IN LENEXA, KANSAS. BERTEK CODE 44119 MEDILAM 3600 MANUFACTURED IN ST. ALBANS, VERMONT. PIRACETAM MANUFACTURED IN BRAINE L'ALLEUD, BELGIUM. PIRACETAM TABLETS 80 MG AND 1200 MG MANUFACTURED IN BRAINE L'ALLEUD, BELGIUM. SOTALOL HYDROCHLORIDE MANUFACTURED IN CORK, IRELAND. PROMETHAZINE HYDROCHLORIDE MANUFACTURED IN WICKLOW, IRELAND. BISMUTH SUBSALICYLATE MANUFACTURED IN CANOVELLES, SPAIN. FLUMECINOL MANUFACTURED IN GENNEVILILERS, FRANCE.

MARUTI INDUSTRIAL CARBOHYDRATES LTD SODIUM CARBOXYMETHYL CELLULOSE (CMC) MANUFACTURED IN TAMILNADU, INDIA.

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4Q2012EXCEL DMF# 11892 I 11893 11894 11895 I 11896 A 11897 11898 I 11899 A 11900 11901 11902 11903 11904 I 11905 A 11906 11907 A 11908 11909 A 11910 A 11911 11912 I 11913 11914 11915 11916 I 11917 11918 11919 11920 A I I I II II II II 4/9/1996 4/9/1996 4/9/1996 4/9/1996 BOEHRINGER MANNHEIM SA BOEHRINGER MANNHEIM SA BOEHRINGER MANNHEIM SA PHARM ECO LABORATORIES INC I I I IV III III V 3/28/1996 3/21/1996 4/8/1996 4/3/1996 DAVID MICHAEL AND CO INC BASF AKTIENGESELLSCHAFT DSM RESEARCH SCHERING PLOUGH PRODUCTS INC I II III 3/29/1996 4/2/1996 MILLIPORE CORP NALGE NUNC INTL II 3/28/1996 SUNLIT FLUO AND CHEMICAL CO LTD I II II 3/29/1996 3/29/1996 KOEI CHEMICAL CO LTD YUNNAN HANDE BIO TECH CO LTD N II 3/31/1996 II 3/29/1996 A I A I II II II II I 3/22/1996 3/26/1996 3/26/1996 3/29/1996 3/29/1996 II 3/25/1996 FIDIA FARMACEUTICI SPA DIVISIONE SOLMAG MEITO SANGYO CO LTD ARZNEIMITTELWERK DRESDEN GMBH ALBEMARLE CORP AARON INDUSTRIES INC SHANDONG WEI FANG PHARMACEUTICAL FACTORY SHANDONG WEIFANG PHARMACEUTICAL FACTORY CO LTD NOT AN ASSIGNED NUMBER KOEI CHEMICAL CO LTD I II II 3/21/1996 3/11/1996 II 3/18/1996 A I II II I 3/18/1996 3/15/1996 3/11/1996 BORREGAARD INDUSTRIES LTD FINE CHEMICALS CORP FOREST LABORATORIES IRELAND LTD STATUS Type SUBMIT DATE II 3/14/1996 HOLDER PHARM ECO LABORATORIES INC SUBJECT

4Q2012

3(S)-N-(3-FURANOXYCARBONYL)AMINO-1-(N,N-ISOBUTYLAMINO, 4AMINOBENZENESULFONYL)AMINO-2(S)-HYDROXY-4-PHENYLBUTANE MANUFACTURED IN NORTH ANDOVER, MASSACHUSETTS. IOXILAN BULK DRUG SUBSTANCE MANUFACTURED IN SARPSBORG, NORWAY. ASTEMIZOLE MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA.

MANUFACTURING SITE, FACILITIES,PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DUBLIN, IRELAND. UNION QUIMICO FARMACEUTICA SA UQUIFA ACYCLOVIR MANUFACTURED IN LLICA DE VALL AND SAINT CELONI BARCELONA, SPAIN. SA HOECHST CELANESE CORP CLONAZEPAM MANUFACTURED IN CORPUS CHRISTI, TEXAS. CIS US INC META-IODOBENZYLGUANIDINE SULFATE (MIBG-S) MANUFACTURED IN BEDFORD, MASSACHUSETTS. HYDROXYUREA MANUFACTURED IN MULAZZANO, (MI) ITALY. IRON OXIDE/CARBOXYDEXTRAN SOL MANUFACTURED IN AICHI, JAPAN. CARBAMAZEPINE MANUFACTURED IN RADEBEUL, GERMANY. FLURBIPROFEN USP & BP MANUFACTURED IN SOUTH HAVEN, MICHIGAN. ZINC GLUCONATE USP MANUFACTURD IN CLINTON, SOUTH CAROLINA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF CAPTOPRIL USP IN SHANDONG, PEOPLES REPUBLIC OF CHINA. CAPTOPRIL USP MANUFACTURED IN SHANDONG, THE PEOPLES REPUBLIC OF CHINA.

2-HYDROXYMETHYL-4-(3-METHOXYPROPOXY)-3-METHYLPYRIDINE MANUFACTURED IN OSAKA, JAPAN. (3-N-ISOPROPYLAMINO-2-PIPERAZINYL) PYRIDINE MANUFACTURED IN OSAKA, JAPAN. PACLITAXEL DRUG SUBSTANCE MANUFACTURED IN KUNMING, PEOPLES REPUBLIC OF CHINA. SODIUM FLUORIDE USP MANUFACTURED IN TAIWAN, PEOPLES REPUBLIC OF CHINA AND BY HASHIMOTO CHEMICAL CORPORATION IN OSAKA, JAPAN. PROSEP A HIGH CAPACITY MANUFACTURED IN COUNTY DURHAM, UNITED KINGDOM. NALGENE PETG MEDIA AND SERUM BOTTLES MANUFACTURED IN ROCHESTER, NEW YORK. ARTIFICIAL TUTTI FLAVOR #16007 MANUFACTURED IN PHILADELPHIA, PENNSYLVANIA. NOVOLEN 3245 PC MANUFACTURED BY BASF ESPANOLA S.A. IN TARAGONA, SPAIN. RONFALIN SFC34-** MANUFACTURED IN BEEK, THE NETHERLANDS. STERILE PRODUCTS MANUFACTURING UPGRADE MANUFACTURED IN MANATI, PUERTO RICO. 4-EPITETRACYCLINE HYDROCHLORIDE MANUFACTURED IN BARCELONA, SPAIN. N-DECYLMETHYLSULFOXIDE MANUFACTURED IN BARCELONA, SPAIN. TOPICYCLINE MANUFACTURED IN BARCELONA, SPAIN. L-2'[2-1-METHYL-2-PIPERIDYL)ETHYL] CINNAMANILIDE MANUFACTURED IN LEXINGTON AND NORTH ANDOVER, MASSACHUSETTS.

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4Q2012EXCEL DMF# 11921 I 11922 I 11923 I 11924 I 11925 I 11926 I 11927 11928 I 11929 A 11930 I 11931 I 11932 A 11933 I 11934 I 11935 A 11936 11937 11938 A 11939 11940 11941 11942 11943 11944 11945 11946 I 11947 A II 4/26/1996 BASF PHARMA EVIONNAZ SA A A A I I I I II II II II II II II II 4/23/1996 4/25/1996 4/25/1996 4/24/1996 4/24/1996 4/24/1996 4/24/1996 4/25/1996 ALBEMARLE CORP ALBEMARLE CORP ALBEMARLE CORP YAMASA CORP YAMASA CORP YAMASA CORP YAMASA CORP LABORATORI MAG SPA I I II II II 4/19/1996 6/12/1996 4/18/1996 SYNKEM DIV PLASTO SA MOUNT SINAI MEDCTR BASF PHARMA EVIONNAZ SA II 4/18/1996 WOCKHARDT LTD II 4/16/1996 STANDARD ORGANICS LTD IV 5/17/1996 WORTHEN INDS II 4/17/1996 V 3/20/1996 EASTERN COOPERATIVE ONCOLOGY GROUP LONZA AG CLINICAL TRIALS BY ECOG IN BROOKLINE, MASSACHUSETTS. III 4/11/1996 AMPACET CORP IV 4/15/1996 PAULAUR CORP A II III 4/17/1996 4/17/1996 CAMBREX PROFARMACO MILANO SRL CATALENT PHARMA SOLUTIONS LLC IV 4/16/1996 ALEX FRIES AND BROTHERS INC II 4/17/1996 CATALYTICA PHARMACEUTICALS INC II 4/17/1996 GROUPE LIPHA IV 4/10/1996 II 4/15/1996 R.W JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE F AND C WILD FLAVORS INC STATUS Type SUBMIT DATE III 4/9/1996 HOLDER EXXON CHEMICAL CO SUBJECT

4Q2012

ESCORENE PP 1385 H1 MANUFACTURED BY EXXON CHEMICAL FRANCE IN NOTRE-DAMEDE-GRAVENCHON, FRANCE. 17-DEACETYLNORGESTIMATE/ETHINYL ESTRADIOL TRANSDERMAL CONTRACEPTIVE SYSTEM MANUFACTURED IN REDWOOD CITY, CALIFORNIA. ARTIFICIAL TOASTED COCONUT FLAVOR #18408T MANUFACTURED IN CINCINNATI, OHIO METFORMIN HYDROCHLORIDEMANUFACTURED BY LIPHA SEMOY IN SEMOY CEDEX, FRANCE. N-ISOPROPYL-2(1-PIPERAZINYL)-3-PYRIDINAMINE MANUFACTURED IN EAST PALO ALTO, CALIFORNIA. ARTIFICIAL STRAWBERRY ICE CREAM FLAVOR 84-192 W/S LIQUID MANUFACTURED IN CINCINNATI, OHIO. TERBUTALINE SULFATE MANUFACTURED IN PAULLO (MILANO) ITALY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN HUMACAO, PUERTO RICO.TYPE I CONVERSION TO TYPE III NONPAREIL SEEDS (SUGAR SPHERES, N.F.) MANUFATURED IN CRANBURY, NEW JERSEY. 100600 UV POLYETHYLENE MASTERBATCH MANUFACTURED IN TERRE HAUTE, INDIANA, DERIDDER, LOUISIANA, CARTERSVILLE, GEORGIA, AND MESSANCY, BELGIUM.

DL-2-(DIFLUOROMETHYL) ORNITHINE MONOHYDROCHLORIDE MONOHYDRATE MANUFACTURED IN VISP, SWITZERLAND. TWO-PART POLYURETHANE LAMINAING ADHESIVES SYSTEM SW 042/SW-043 MANUFACTURED IN NASHUA, NEW HAMPSHIRE. TRIMETHOPRIM USP (NON-STERILE BULK) MANUFACTURED IN ANDHRA PRADESH, INDIA. DEXTROMETHORPHAN HYDROBROMIDE USP MANUFACTURED IN GUJARAT STATE, INDIA. PHENTOLAMINE MESYLATE MANUFACTURED IN CHENOVE, FRANCE. INDIUM-111 CHLORIDE STERILE SOLUTION, MANUFACTURED IN MIAMI, FLORIDA. BUPIVACAINE BASE MANUFACTURED IN EVIONNAZ, SWITZERLAND OR BY ORGAMOL FRANCE IN ST-VULBAS, FRANCE. NAPROXEN (RACEMIC) MANUFACTURED IN ORANGEBURG, SOUTH CAROLINA. NAPROXEN SODIUM MANUFACTURED IN ORANGEBURG, SOUTH CAROLINA. NAPROXEN MANUFACTURED IN ORANGEBURG, SOUTH CAROLINA. 2'-DEOXYADENOSINE MONOHYDRATE MANUFACTURED IN CHIBA-KEN, JAPAN. 2'-DEOXYCYTIDINE HYDROCHLORIDE MANUFACTURED IN CHIBA-KEN, JAPAN. 2'-DEOXYGUANOSINE MONOHYDRATE MANUFACTURED IN CHIBA-KEN, JAPAN. THYMIDINE MANUFACTURED IN CHIBA-KEN, JAPAN. FENFLURAMINE HYDROCHLORIDE MANUFACTURED IN GARBAGNATE, MILANESE, ITALY. OXYBUTYNIN BASE MANUFACTURED IN EVIONNAZ, SWITZERLAND OR BY ORGAMOL FRANCE S.A. IN ST-VULBAS, FRANCE.

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4Q2012EXCEL DMF# 11948 11949 A 11950 I 11951 11952 11953 I 11954 11955 I 11956 11957 I 11958 11959 11960 I 11961 11962 I 11963 A 11964 I 11965 I 11966 A 11967 IV 5/9/1996 WILLETT SYSTEMS LTD II 2/21/1996 QUIMICA SINTETICA SA III 5/8/1996 CLARIANT CORPORATION I 5/9/1996 J RETTENMAIER & SOHNE GMBH + CO** IV 5/9/1996 JRS PHARMA GMBH AND CO KG I III I 5/6/1996 5/3/1996 BOREALIS AS 3M PHARMACEUTICALS PARTY LTD A A II II IV 5/2/1996 5/6/1996 5/9/1996 AMRI RENSSELAER INC CHEMAGIS LTD LACTOSE NEW ZEALAND LTD I II IV 5/9/1996 5/8/1996 MITSUBISHI CHEMICAL CORP MASTERTASTE INC I II I 5/3/1996 5/6/1996 DSM ANDENO BV LUKIAN PLASTIC CLOSURES LTD C I II II II 4/29/1996 5/2/1996 5/3/1996 CHEMI SPA CHEMI SPA MOUNT SINAI MEDCTR II 5/1/1996 MOUNT SINAI MEDCTR STATUS Type SUBMIT DATE A II IV 4/24/1996 4/23/1996 HOLDER EVONIK TECHNOCHEMIE GMBH F AND C WILD FLAVORS INC SUBJECT NIFEDIPINE MANUFACTURED IN RADEBEUL, GERMANY.

4Q2012

ARTIFICIAL CHERRY RASPBERRY FLAVORS #101253 AND 10125T MANUFACTURED IN CINCINNATI, OHIO. BULK RADIOCHEMICAL THALLIUM-201 CHLORIDE AND THALLIUM-201 STERILE SOLUTION MANUFACTURED IN MIAMI BEACH, FLORIDA. 5-ASA MANUFACTURED IN PATRICA (FROSINONE) ITALY. 5-ASA CRYSTALLIZED MANUFACTURED IN PATRICA (FROSINONE) ITALY. BULK RADIOCHEMICAL GALLIUM-67 CHLORIDE MANUFACTURED IN MIAMI BEACH, FLORIDA. R-SETRON-S MANUFACTURED IN VENLO, THE NETHERLANDS. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF PLASTIC CAPS IN ONTARIO, CANADA. MKC-442 DRUG SUBSTANCE MANUFACTURED IN IBARAKI PREFECTURE, JAPAN. NATURAL AND ARTIFICIAL RASPBERRY FLAVOR FOR MASKING 650008 MANUFACTURED IN TETERBORO, NEW JERSEY. METOLAZONE, USP MANUFACTURED IN RENSSELAER, NEW YORK. TRAMADOL HYDROCHLORIDE MANUFACTURED IN BEER SHEVA, ISRAEL. LACTOSE MONOHYDRATE SPRAY DRIED NF, USP MANUFACTURED IN KAPUNI, NEW ZEALAND. PACKAGING MATERIAL HH315P MANUFACTURED IN STATHELLE, NORWAY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN THRONLEIGH NSW, AUSTRALIA. MICROCRYSTALLINE CELLULOSE USP NF VIVAPUR(TM) - VARIOUS GRADES (CAS NO.9004-34-6) MANUFACTURED IN WEISSENBORN, GERMANY MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURE OF MICROCRYSTALLINE CELLULOSE USP NF BY MICROCELLULOSE WEISSENBORN GMBH + CO IN WEISSENBORN, GERMANY. CLC-16645 25/1 LIGHT GREY COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS. CIPROFLOXACIN HYDROCHLORIDE (NEW SYNTHETIC PATHWAY) MANUFACTURED IN MADRID, SPAIN. CIJ ETHANOL MICRO PILL CODING BLUE PART201-0001-220,FG SF TOP-UP PART201-0001221,ET 3920E BLUE & TOP-UP PART201-0001-620 &201-0001-720 AND CIJ ET 3912F WASHDOWN PART 201-0001-721 MANUFACTURED BY WARNER JENKINSON EUROPE IN NORFOLK,UK TICLOPIDINE HYDROCHLORIDE MANUFACTURED IN BERGAMO, ITALY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF BULK DRUG IN BUBENDORF, SWITZERLAND. MODAFINIL DRUG SUBSTANCE MANUFACTURED IN MITRY-MORY CEDEX, FRANCE AND BY ISOCHEM IN GENNEVILLIERS CEDEX, FRANCE. CYCLOSPORINE MANUFACTURED IN OPAVA, CZECH REPUBLIC. PYRIDOSTIGMINE BROMIDE TABLETS USP 30MG MANUFACTURED IN NUTLEY NJ BROMOCRIPTINE MESYLATE MANUFACTURED IN OPAVA, CZECH REPUBLIC. ACYCLOVIR, USP MANUFACTURED IN ST. LOUIS, MISSOURI.

I 11968 11969 I 11970 A 11971 11972 11973 11974 I I I I II II II II 5/13/1996 5/10/1996 5/6/1996 5/8/1996 GALENA AS ROCHE PRODUCTS LTD GALENA AS MALLINCKRODT CHEMICAL INC II 5/15/1996 CEPHALON FRANCE A II I 5/17/1996 5/14/1996 ERREGIERRE SPA BACHEM FEINCHEMIKALIEN AG

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4Q2012EXCEL DMF# 11975 I 11976 I 11977 I 11978 I 11979 I 11980 11981 I 11982 11983 11984 11985 I 11986 I 11987 I 11988 I 11989 I 11990 11991 11992 11993 I 11994 11995 A 11996 A 11997 11998 11999 I 12000 A 12001 A III 6/18/1996 III 6/18/1996 CCC PLASTICS CANADA COLORS AND CHEMICALS LTD CANADA COLORS AND CHEMICALS LTD A A II III II 6/10/1996 5/24/1996 6/12/1996 GEDEON RICHTER PLC NIPRO CORP MOUNT SINAI MEDCTR IV 6/5/1996 LIPOID GMBH A II II 6/4/1996 6/10/1996 SANYO FINE CO LTD MERCK SANTE SAS I I I II II II I 6/6/1996 6/3/1996 6/7/1996 6/4/1996 CHENG FONG CHEMICAL CO LTD GEDEON RICHTER LTD NATCO PHARMA LTD CHEMICAL DIV SANYO FINE CO LTD IV 5/10/1996 TRICON VEREDLUNGS GMBH III 6/7/1996 REXAM PHARMA SAS II 6/4/1996 I 6/1/1996 NORTHEAST GENERAL PHARMACEUTICAL FACTORY LANXESS CORPORATION A I A II II II II 5/31/1996 5/31/1996 6/3/1996 6/3/1996 A II II 5/24/1996 5/29/1996 QUIMICA SINTETICA SA ISTITUTO BIOLOGICO CHEMIOTERAPICO SPA DIVISIONE UNIBIOS YAMANOUCHI PHARMACEUTICAL CO LTD TAIHO PHARMACEUTICAL CO LTD ESTEVE QUIMICA SA LABORATORI MAG SPA III 5/13/1996 BASF AKTIENGESELLSCHAFT II 5/24/1996 BACHEM INC V 5/24/1996 HIKMA FARMACEUTICA PORTUGAL LDA II 5/14/1996 SANOFI SYNTHELABO INC. STATUS Type SUBMIT DATE II 5/21/1996 HOLDER CATALYTICA PHARMACEUTICALS SUBJECT

4Q2012

5-METHANESULFONAMIDOINDOLE-2-CARBOXYLIC ACID (MACA) MANUFACTURED IN EAST PALO ALTO, CALIFORNIA. ALFUZOSIN HYDROCHLORIDE DRUG SUBSTANCE MANUFACTURED IN GARGENVILLE, FRANCE. STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN SINTRA, PORTUGAL CORTICORTROPIN RELEASING FACTOR, HUMAN , ACETATE SALT MANUFACTURED IN TORRANCE AND SAN DIEGO, CALIFORNIA. STYROLUX 656 C MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY. KETOROLAC TROMETHAMINE MANUFACTURED IN MADRID, SPAIN. ACYCLOVIR MANUFACTURED IN TRECATE AND SORBOLO, ITALY. YM435 MANUFACTURED IN IBARAKI-KEN, JAPAN. TAS-103 MANUFACTURED IN SAITAMA, JAPAN. NABUMETONE MANUFACTURED IN BARCELONA, SPAIN. DEXFENFLURAMINE HYDROCHLORIDE MANUFACTURED IN GARBAGNATE MILANESE, ITALY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BEI ST., TIEXI DISTRICT OF SHENYANG, P.R. CHINA. PREVENTOL SB MANUFACTURED BY BAYER AG IN LEVERKUSEN AND DORMAGEN, GERMANY. PLASTIC CHILDPROOF INNER LID PP WHITE WITH NEW MASTERBACH MANUFACTURED IN OFFRANVILLE, FRANCE. PET FILM 15U ONE SIDE ALUMINIZED AND PRIMERED, SECOND SIDE OCHER COLOUR PRINTING MANUFACTURED IN FREIBURG, GERMANY. DICLOFENAC POTASSIUM MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA. VINCA ROSEA EXTRACT MANUFACTURED IN BUDAPEST, HUNGARY. FLUOXETINE HYDROCHLORIDE MANUFACTURED IN ANDHRA PRADESH, INDIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF 5,6-DIMETHOXY-1-INDANONE MANUFACTURED IN HYOGO PREFECTURE, JAPAN. 5,6-DIMETHOXY-1-INDANONE MANUFACTURED IN HYOGO PREFECTURE, JAPAN. CALCIUM ACAMPROSATE NEW DRUG SUBSTANCE MANUFACTURED IN MEYZIEU, FRANCE. LIPOID PC 18:0/18:0, 1, 2-DISTEAROYL-SN-GLYCERO-3-PHOSPHO CHOLINE MANUFACTURED IN LUDWIGSHAFEN, GERMANY 3-KETODESOGESTREL MANUFACTURED IN BUDAPEST AND DOROG, HUNGARY. VIALS MANUFACTURED IN SHIGA, JAPAN. BULK RADIOCHEMICAL INDIUM-111 CHLORIDE MANUFACTURED IN MIAMI BEACH, FLORIDA. WHITE MB 20-902 POLYETHELENE COLOUR CONCENTRATE MANUFACTURED IN COLBORNE, ONTARIO, CANADA. WHITE WB 20-960 POLYETHELENE COLOUR CONCENTRATE MANUFACTURED IN COLBORNE, ONTARIO, CANADA.

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4Q2012EXCEL DMF# 12002 12003 12004 I 12005 I 12006 I 12007 I 12008 12009 A 12010 12011 I 12012 12013 12014 I 12015 12016 12017 12018 I 12019 12020 12021 12022 I 12023 12024 I 12025 I 12026 12027 12028 A 12029 I 12030 I II 7/2/1996 ASH STEVENS INC II 7/3/1996 WATSON LABORATORIES I I II III II 7/2/1996 6/18/1996 7/8/1996 TAKEDA CHEMICAL INDUSTRIES LTD DRYCOLOR AB MICROBIOPHARM JAPAN CO LTD II 7/3/1996 WATSON LABORATORIES A II V 6/25/1996 7/1/1996 QUIMICA SINTETICA SA PPD WARS DIV PPD CRV INC I I A II II II II 6/28/1996 6/25/1996 6/27/1996 7/3/1996 ABBOTT LABORATORIES CHIREX LTD ESTEVE QUIMICA SA GE SILICONES D-CHIRO-INOSITOL, MANUFACTURED IN NORTH CHICAGO, IL KETOPROFEN MANUFACTURED IN DUDLEY ENGLAND DICLOFENAC POTASSIUM MANUFACTURED IN TARRAGONA SPAIN A A I II III II II 6/25/1996 6/25/1996 6/27/1996 6/28/1996 FERRO PFANSTIEHL BD MEDICAL PHARMACEUTICAL SYSTEMS ICN CZECH REPUBLIC AS AVANTI POLAR LIPIDS INC I I II III V 6/24/1996 6/25/1996 6/24/1996 DEGUSSA AG HYGENIC CORP PPD WARS DIV PPD CRV INC A II I 6/20/1996 6/20/1996 YUKI GOSEI KOGYO CO LTD MYLAN INC I III II 6/17/1996 6/19/1996 DEBIO RECHERCHE PHARMACEUTIQUE SA SIFAVITOR SRL III 6/19/1996 IV 6/3/1996 IV 6/3/1996 STATUS Type SUBMIT DATE I A II II IV 6/17/1996 6/17/1996 6/3/1996 HOLDER DIOSYNTH BV CHEMAGIS LTD TECHNOLOGY FLAVORS & FRAGRANCES INC TECHNOLOGY FLAVORS & FRAGRANCES INC TECHNOLOGY FLAVORS & FRAGRANCES INC 3M PHARMACEUTICALS INC SUBJECT VECURONIUM BROMIDE MANUFACTURED IN OSS, THE NETHERLANDS. AMMONIUM LACTATE MANUFACTURED IN BEER SHEVA, ISRAEL.

4Q2012

ARTIFICIAL BLUEBERRY FLAVOR 844-443 MANUFACTURED IN AMITYVILLE, NEW YORK. ARTIFICIAL BOYSENBERRY FLAVOR 844-509 MANUFACTURED IN AMITYVILLE, NEW YORK. ARTIFICIAL BLUEBERRY FLAVOR 844-112 MANUFACTURED IN AMITYVILLE, NEW YORK. COTRAN EVA FILM, MSP050994P MANUFACTURED BY 3M MEDICAL/SURGICAL DIVISION PLANT AND 3M COMMERICAL GRAPHICS PILOT PLANT IN BROOKINGS, SOUTH DAKOTA AND ST. PAUL, MINNESOTA. DEBIOJECT SINGLE DOSE DELIVERY SYSTEM FLUOXETINE HYDROCHLORIDE MANUFACTURED IN FRAZIONE MAIRANO (MILANO) ITALY. TRIFLUOROTHYMIDINE IN JOBAN, IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF TRIFLUOROTHYMIDINE IN JOBAN, IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN. CISPLATIN MANUFACTURED IN HANAU, GERMANY. TUBING GAR1030 MANUFACTURED IN CUYAHOGA FALLS, OHIO. METHODS WARS-P317.01 DETERMINATION OF CLOZAPINE AND NORMETHYLCLOZAPINE IN HUMAN PLASMA BY GAS LIQUID CHROMATOGRAPHY MALTOSE HIGH PURITY HYDRATE (LOW ENDOTOXIN) PLASTIC PRE-FILLABLE STERILE SYRINGE SYSTEM L-EPHEDRINE HYDROCHLORIDE, MANUFACTURED IN ROZTOKY, CZECH REPUBLIC TETRAMYRISTOYL CARDIOLIPIN (14:0 CA) MANUFACTURED IN ALABASTER, ALABAMA

BAYSILONE FLUID M PH 300, 350, 500, 1000, 1500, MANUFACTURED IN BAYERWERK, GERMANY KETOCONAZOLE MANUFACTURED IN MADRID SPAIN DETERMINATION OF N-0923 IN HUMAN PLASMA BY GC/MS (WARS-P333.00) AND BY LC/MS/MS (WARS P380.00) HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, 10 MG\650 MG MANUFACTURED IN CORONA, CA 91720 TAK-603,MANUFACTURED IN OSAKA, JAPAN MASTER BACH PE 192214 MANUFACTURED IN MALMO, SWEDEN (1S,3R)-1,3-BIS(TERT-BUTYLDIMETHYLSILYLOXY) ANDROST-5-EN-17-ONE (SI-HDEA) MANUFACTURED IN KANAGAWA 251, JAPAN HYDROCODONE BITARTRATE TABLETS, 10 MG MANUFACTURED IN CORONA, CALIFORINA 2',3'-DIDEOXY-2'-B-FLUORO-ADENOSINE MANUFACTURED IN RIVERVIEW, MI

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4Q2012EXCEL DMF# 12031 12032 I 12033 I 12034 I 12035 12036 12037 A 12038 12039 12040 I 12041 12042 A 12043 A 12044 12045 12046 12047 12048 A 12049 12050 A 12051 12052 A 12053 12054 12055 I 12056 I 12057 I 12058 I 12059 A 12060 I II 7/26/1996 CUNO INC II 7/26/1996 3M PURIFICATION INC I 7/17/1996 ADVANCED MATERIAL RESOURCES I 7/11/1996 II 7/22/1996 PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA KERPLAS NEUENBURG GMBH I I III I II 7/17/1996 7/12/1996 7/19/1996 TEUSCHER KUNSTSTOFF-TECHNIK AG TEUSCHER KUNSTSTOFF-TECHNIK AG GENZYME PHARMACEUTICALS VETTER LYO-JECT MANUFACTURED IN GRECHEN, SWITZERLAND THE VETTER LYO-JECT MANUFACURED IN GRECHEN, SWITZERLAND I III II 7/19/1996 7/18/1996 I II II 7/19/1996 7/23/1996 CUNO INC ZHEJIANG XIANJU PHARMACEUTICAL CO LTD MYLAN TECHNOLOGIES INC MALLINCKRODT INC I I A A III II II III II 7/10/1996 7/15/1996 7/19/1996 7/16/1996 6/30/1996 ISHIDA PRESS KOGYO CO LTD GREAT LAKES CHEMICAL CORP INC SYNTHESIA AS ALLTUB FRANCE SAS III 7/11/1996 LOPAREX BV I III III 7/5/1996 6/4/1996 ELAG VERPACKUNGEN AG INEOS OLEFINS AND POLYMERS USA I I I III III 7/12/1996 7/2/1996 6/13/1996 ORGANICHEM CORP ADVANCED ELASTOMER SYSTEM BASF AKTIENGESELLSCHAFT I A II II II 7/3/1996 7/3/1996 7/10/1996 BRITISH BIOTECHNOLOGY PLC SHASUN PHARMACEUTICALS LTD CAMBREX PROFARMACO MILANO SRL I 6/25/1996 GENELABS DIAGNOSTICS PTE LTD I 7/30/1996 GROUPE LIPHA STATUS Type SUBMIT DATE I III II 7/11/1996 7/5/1996 HOLDER POLYFIL CORP NORDMARK ARZNEIMITTEL GMBH SUBJECT AMC-0500-50 AND AMC-0500-95 MANUFACTURED IN DOVER, NEW JERSEY

4Q2012

PANCRELIPASE ENTERIC COATED MICROTABLETS MANUFACTURED IN UETERSEN, GERMANY LIPHA LACASSAGNE; MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES, AND PERSONNEL IN SINGAPORE LEXIPAFANT (BB-882) TABLETS MANUFACTURED IN EDINBURG, SCOTLAND S-IBUPROFEN MANUFACTURED IN PONDICHERRY, INDIA NOREPINEPHRINE BITARTRATE OR NORADRENALINE ACID TARTRATE, MANUFACTURED IN MILANO, ITALY LINDESNES PLANT IN SPANGEREID NORWAY ADVANCED ELASTOMER SYSTEMS PRODUCT BM62 MANUFACTURED IN AKRON, OHIO STYROFAN N 920 MANUFACTURED IN LUDWIGSHAFEN, (FEDERAL REPUBLIC OF GERMANY) BOTTOM GUSSET BAGS MANUFACTURED IN KIRCHBERG, SWITZERLAND POLYPROPYLENE RESINS-GENERAL FORMULATIONS MANUFACTURED IN CHICAGO, ILLINOIS FL2000TM 100 UM PET EASY\EASY (PRODUCT CODE 78G101) MANUFACTURED IN APELDOORN, THE NETHERLANDS STORAGE OF ALUMINUM CAPS FOR VIALS SAITAMA, JAPAN ISOFLURANE,MANUFACTURED IN EL DORADO, ARKANSAS MITOXANTRONE HYDROCHLORIDE USP MANUFACTURED IN SEMTIN, CZECH REPUBLIC ALUMINUM COLLAPSIBLE TUBES MANUFACTURED IN SAUMUR, FRANCE

FUJIAN FUKANG PHARMACEUTICAL CO LTD GENTAMICIN SULFATE MANUFACTURED IN FUZHOU, CHINA ZETA PLUS DELIPID FILTER MEDIUM, MANUFACTURED IN STAFFORD SPRINGS, CT VECURONIUM BROMIDE MANUFACTURED IN ZHEJIANG, CHINA MEDIDERM 3800, MANUFACTURED IN ST. ALBANS, VT 05478 LEUPROLIDE ACETATE, (ESUB) MANUFACTURED IN ST. LOUIS, MISSOURI

N-[2-(5-METHOXYINDOL-3-YL)ETHYL] ACETAMIDE (MELATONIN) MANUFACTURED IN SUFFOLK, ENGLAND FENFLURAMINE HYDROCHLORIDE, MANUFACTURED IN VARESE, ITALY MANUFACTURING AND CONTROL PROCEDURES FOR PACKAGING. MANUFACTURING AT NEUENBURG AM RHEIN/GERMANY RAW MATERIAL MANUFACTURING SITE, FACILITIES, PROCESSED IN JIANYIN, JIONGSU PROVINCE, CHINA. ZETA PLUS FOR AP,CA, CP, HP, HTP, HTM, L, LA, LP, LPM, M, SA, SP, VR, Z, ZA, AND DELIPID PRODUCTS SERIES MANUFACTORED AT STAFFORD SPRING, CT ZETA PLUS CA, LA, SA, SERIES. MANUFACTURED A STAFFORD SPRINGS, CT.Page 349

4Q2012EXCEL DMF# 12061 12062 12063 12064 A 12065 12066 12067 A 12068 12069 I 12070 12071 12072 I 12073 12074 12075 I 12076 I 12077 A 12078 12079 12080 12081 I 12082 12083 I 12084 I 12085 12086 12087 A 12088 12089 12090 12091 I 12092 A II 8/1/1996 NOVACYL SAS I I I II II II II 8/9/1996 8/12/1996 8/13/1996 8/13/1996 POLFA TARCHOMIN CILAG AG LOHMANN LTS DINAMITE DIPHARMA SPA I A II II III 8/13/1996 8/2/1996 8/13/1996 KREBS BIOCHEMICALS LTD LUPIN LTD TEKNI PLEX EUROPE NV I 8/13/1996 KREBS BIOCHEMICALS LTD I IV I 8/9/1996 8/8/1996 SONUS PHARMACEUTICALS ACS DOBFAR SPA A A I II II II I 8/5/1996 8/7/1996 8/6/1996 8/8/1996 SYNKEM SAS CELGENE CORP SUMITOMO CHEMICAL CO LTD GROUPE LIPHA III 8/2/1996 V 8/7/1996 KINGS COLLEGE SCH OF MEDICINE AND DENTISTRY GERRESHEIMER VAERLOESE AS I I II II III 8/6/1996 8/6/1996 8/7/1996 BACHEM CALIFORNIA PTI ADVANCED FILTRATION INC SABIC PETROCHEMICALS BV I I III II II 7/25/1996 8/2/1996 8/5/1996 XTP INC ORION CORP FERMION I II II 7/31/1996 7/18/1996 I I II II II 7/26/1996 7/26/1996 7/23/1996 STATUS Type SUBMIT DATE I I A II II II II 7/26/1996 7/26/1996 7/26/1996 7/30/1996 HOLDER CUNO INC CUNO INC EUTICALS SPA BORREGAARD AS, BORREGAARD SYNTHESIS LONZA LTD LONZA LTD BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG MULTIPLE PEPTIDE SYSTEMS GREEN SPRINGS BIOCHEMISTRY SUBJECT ZETA PLUS AP AND CP SERIES, MANUFACTURED IN STAFFORD SPRINGS, CT ZETA PLUS LP SERIES, MANUFACTURED IN STAFFORD SPRINGS, CT VECURONIUM BROMIDE (P 3038), MANUFACTURED IN ROZZANO, ITALY TAI I BULK INTERMEDIATE, MANUFACTURED IN SARPSBORG, NORWAY SB 217063 AND SK&F 109077 MANUFACTURED IN VISP, SWITZERLAND. SB 201999, MANUFACTURED IN VISP, SWITZERLAND

4Q2012

HOMATROPINE HYDROBROMIDE, MANUFACTURED IN INGELHIEM/RHEIN, GERMANY P-113 SYNTHETIC PEPTIDE, MANUFACTURED IN SAN DIEGO, CA PACLITAXEL, MANUFACTURED IN KUNMING AND LIJIANG, YUNNAN, PEOPLE'S REPUBLIC OF CHINA PACKAGING MATERIAL, MANUFACTURED IN BROOKLYN, NY DILTIAZEM HCL PROCESS II, MANUFACTURED IN HANKO, FINLAND

LIANYUNGANG PHARMACEUTICAL FACTORY MESNA, MANUFACTURED IN JIANGSU PROVINCE, PEOPLE'S REPUBLIC OF CHINA ANGIOTENSIN II HUMAN, MANUFACTURED IN TORRANCE AND SAN DIEGO, CALIFORNIA PROFLOW II, MANUFACTURED IN NEWBURY, CALIFORNIA SABIC LDPE 2602TH00 LOW DENSITY POLYETHYLENE, MANUFACTURED IN THE NETHERLANDS PROPRIETARY CLINICAL STUDY RECORDS IN LONDON, UNITED KINGDOM PACKAGING MATERIAL, MANUFACTURED IN VAERLOSE AND FREDRIKSSUND, DENMARK, GISLAVED, AND VAXJO, SWEDEN, AND KENT, ENGLAND FENOFIBRATE MANUFACTURED IN CHENOVE FRANCE FR901228 MANUFACTURED IN AICHI JAPAN SB-210272 (INTERMEDIATE) MANUFACTURED IN OITA, JAPAN MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL LIPHA MEYZIEU, MEYZIEU, FRANCE MEDICAL GRADE PEG TELOMAR B MANUFACTURED IN BOTHELL WA MANUFACTURING FACILITIES, PERSONNEL, AND GENERAL OPERATIONS IN BERGAMO, ITALY EPHEDRINE AND PSEUDOEPHEDRINE MANUFACTURING FACILITIES IN ANDHRA PRADESH, INDIA D-PSEUDOEPHEDRINE HYDROCHLORIDE, U.S.P., MANUFACTURED IN ANDHRA, INDIA 7-ACCA AN INTERMEDIATE FOR CEFACLOR MANUFACTURED IN ANKLESHWAR, INDIA PE-BUTYL PLASTIC STRIP FORMULA, FORMULA S8501, MANUFACTURED IN EREMBODEGEM, BELGIUM 6AP ACID, MANUFACTURED IN WARSAW, POLAND BUPROPION HYDROCHLORIDE, MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND ASPIRIN-TTS (ACETYLSALICYLIC ACID - TRANSDERMAL THERAPEUTIC SYSTEM) NABUMETONE MANUFACTURED IN THE BARANZATE DI BOLLATE (MILAN), ITALY FACILITIES ASPIRIN USP (RHODINE (TM)) MANUFACTURED IN THAILAND

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4Q2012EXCEL DMF# 12093 12094 A 12095 I 12096 I 12097 12098 A 12099 I 12100 A 12101 12102 12103 12104 12105 A 12106 12107 12108 A 12109 A 12110 I 12111 I 12112 I 12113 A 12114 I 12115 12116 12117 12118 12119 12120 I I I I I I II II II IV II II 8/29/1996 9/3/1996 8/27/1996 8/21/1996 9/3/1996 9/5/1996 SICOR SPA B I CHEMICALS INC NAPP TECHNOLOGIES INC MEYERS COLOUR COMPOUNDS LIMITED TASMANIAN ALKALOIDS PARTY LTD QUIMICA ESTEROIDAL SA DE CV I 9/3/1996 SHOWA KAKO CORP III 8/22/1996 LOPAREX LLC III 8/22/1996 LOPAREX INC III 8/22/1996 LOPAREX INC III 8/22/1996 LOPAREX INC III 8/22/1996 LOPAREX LLC I I I II III 7/10/1996 8/29/1996 8/12/1996 LUKIAN PLASTIC CLOSURES LTD DIOSYNTH BV LOPAREX LLC A A A A IV IV II II II 8/19/1996 8/21/1996 8/28/1996 8/28/1996 8/28/1996 CARGILL FLAVOR SYSTEMS EVONIK ROHM GMBH MALLINCKRODT INC AVANTI POLAR LIPIDS INC AVANTI POLAR LIPIDS INC WATERMELON F-11420, MANFACTURED IN LANGHORNE PENNSYLVANIA PLASTOID B, MANUFACTURED IN DARMSTADT, GERMANY III 8/1/1996 I 8/26/1996 A II II 8/23/1996 8/20/1996 III 8/20/1996 CLARIANT CORPORATION MASTERBATCHES DIVISION BASF GRENZACH GMBH JOHNSON MATTHEY PHARMACEUTICAL MATERIALS SHANDONG LUKANG PHARMACEUTICAL CO LTD MYLAN TECHNOLOGIES INC III 8/5/1996 STATUS Type SUBMIT DATE I II II 8/20/1996 8/20/1996 HOLDER ABBOTT LABORATORIES SUBJECT

4Q2012

SIMETHICONE COATED CELLULOSE (SONORX); MANFACTURED IN NORTH CHICAGO, IL

JIANGXI DONGFENG PHARMACEUTICAL LLC PENICILLIN G POTASSIUM (INDUSTRY GRADE), MANUFACTURED IN JIANGXI PROVINCE, PEOPLE'S REPUBLIC OF CHINA CKS PACKAGING, INC. CLEAR AND WHITE PVC CYLINDER, MANFACTURED IN MOORESVILLE, NORTH CAROLINA CLC-16645-A 25/1 LIGHT GREY COLOR CONCENTRATE, MANUFACTURED IN MCHENRY, ILLINOIS TRICLOSAN MANUFACTURED IN GRENZACH-WYHLEN, GERMANY HYDROMORPHONE HCL, MANUFACTURED IN WEST DEPTFORD, NEW JERSEY MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL AT JINING CITY, SHANDONG PROVINCE, CHINA BERTEK CODE 44127 MEDIFLEX 1000 (ESUB) MANUFACTURED IN ST ALBANS, VERMONT

SODIUM MOLYBDATE (99MO) (ESUB) AS MANUFACTURED IN PETTEN, HOLLAND TRIOLEIN, MANUFACTURED IN ALABASTER, ALABAMA 1, 2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHLINE (DOPC), MANUFACTURED IN ALABASTER, ALABAMA PLASTIC CAP MANUFACTURING SITE IN POINTE CLAIRE, QUEBEC AC/2 OXALATE; MANUFACTURED IN OSS, THE NETHERLANDS GRADE 15462, 10 MIL NT STY 92A/000 SILICONE COATED RELEASE LINER, MANUFACTURED IN IOWA CITY, IA; BEDFORD PARK, IL; EDEN, NC GRADE 15020, 3 MIL CL PET B22/000 SILICONE COATED RELEASE LINER; MANUFACTURED IN IOWA CITY, IA; BEDFORD PARK, IL; AND EDEN, NC GRADE 15835, 7 MIL NT HDP 92A/92A SILICONE COATED RELEASE LINER; MANUFACTURED IN IOWA CITY, IA; BEDFORD PARK, IL; EDEN, NC GRADE 15827, 10 MIL NT PVC 92A/000 SILICONE COATED RELEASE LINER, MANUFACTURED IN WEST CHICAGO, IL; IOWA CITY, IA; BEDFORD PARK, IL AND EDEN, NC GRADE 13361, 1.5 MIL CL PET 85A/86B SILICONE COATED RELEASE LINER; MANUFACTURED IN WEST CHICAGO, IL; IOWA CITY, IA; BEDFORD PARK, IL; AND EDEN, NC GRADE 15719, 6 MIL NT STY 92A/000 SILICONE COATED RELEASE LINER; MANUFACTURED IN IOWA CITY, IA; BEDFORD PARK, IL; AND EDEN, NC FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES, MANUFACTURED IN OSAKA, JAPAN PORFIROMYCIN, MANUFACTURED IN ITALY ISOETHARINE HYDROCHLORIDE, MANUFACTURED IN PETERSBURG, VIRGINIA WARFARIN SODIUM CLAHRATE; MANUFACTURED IN COVENTRY, RHODE ISLAND MMB-3479 GREY & MMB-7366 MAUVE; MANUFACTURED IN OAKVILLE, ONTARIO BUTORPHANOL TARTRATE; MANUFACTURED IN TASMANIA, AUSTRALIA ARACURIUM BESYLATE; MANUFACTURED IN TLALNEPANTLA, STATE OF MEXICO, MEXICO

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4Q2012EXCEL DMF# 12121 I 12122 I 12123 A 12124 12125 12126 I 12127 12128 I 12129 12130 12131 A 12132 12133 C 12134 12135 12136 I 12137 I 12138 12139 12140 I 12141 12142 I 12143 12144 12145 12146 A 12147 12148 12149 12150 A A A I II IV II IV 9/26/1996 10/1/1996 10/7/1996 10/4/1996 JOHNSON MATTHEY INC IPR PHARMACEUTICALS INC JRS PHARMA LP I I I III III II II 9/26/1996 9/26/1996 10/9/1996 10/2/1996 A II I 9/23/1996 9/19/1996 NV ORGANON NORTON GELKAPS GELATINE KASPEL PRODUKTION GMBH RESCO COLOURS INC RESCO COLOURS INC FMC CORP TEVA PHARMACEUTICAL INDUSTRIES LTD A I II II II 9/9/1996 9/23/1996 9/20/1996 BAYER PHARMA AG CELSIS INTERNATIONAL PLC PHARM WALDHOF GMBH II 9/16/1996 LONZA LTD I A II II II 9/13/1996 9/16/1996 9/12/1996 A III II 9/6/1996 9/17/1996 TOPAS ADVANCED POLYMERS GMBH A I III II III 8/21/1996 8/6/1996 8/27/1996 A II II 9/11/1996 9/12/1996 PFIZER INC GUANGDONG QINGYUAN NEW NORTH RIVER PHARMACEUTICALS CO BASF CORP PHYTOGEN LIFE SCIENCES INC 3M DRUG DELIVERY SYSTEMS A I II IV I 9/4/1996 8/30/1996 9/11/1996 LANDEN PHARMACHEM NV RESCO COLOURS FERRING PEPTIDE PRODUCTION AB III 8/30/1996 II 9/3/1996 STATUS Type SUBMIT DATE II 9/6/1996 HOLDER EMMELLEN BIOTECH PHARMACEUTICALS LTD SHANDONG LUKANG PHARMACEUTICAL CO LTD BOREALIS AG SUBJECT

4Q2012

D-PSEUDOEPHEDRINE HYDROCHLORIDE, MANUFACTURED IN TAMIL NADU, INDIA PENICILLIN G POTASSIUM BULK NON-STERILE INTERMEDIATE FOR FURTHER PROCESSING, MANUFACTURED IN JINING CITY, SHANDONG PROVINCE, CHINA BORMED RF825MO, BORMED RF825MO-01, BORMED RF830MO AND BORMED RG835MO AS MANUFACTURED IN BERINGEN, BELGIUM NITAZOXANIDE, MANUFACTURED IN LANDEN, BELGIUM BLUE CONCENTRATE (04VFV-415), MANUFACTURED IN ONTARIO, CANADA FACILITIES, PERSONNEL, QUALITY ASSURANCE, QUALITY CONTROL, MANFACTURING AND GENERAL OPERATING PROCEDURES ALPHAMETHYL EPOXIDE, MANUFACTURED IN KALAMAZOO, MICHIGAN TOBRAMYCIN, MANUFACTURED IN GUANGDONG PROVINCE, PEOPLE'S REPUBLIC OF CHINA LUPHEN DDS 3459, MANUFACTURED IN SCHWARZHEIDE, GERMANY PACLITAXEL, MANUFACTURED IN DELTA, BC, CANADA A66010 25U SPRAYMISER, VALVE ASSEMBLY LOCATED AT LANCASHIRE, GREAT BRITAIN TOPAS CYCLIC OLEFIN COPOLYMERS, MANUFACTURED IN OBERHAUSEN, GERMANY

ZHEJIANG HISUN PHARMACEUTICAL CO LTD LOVASTATIN USP, NONSTERILE BULK DRUG, JIOJIANG, ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF CHINA EURAND AMERICA INC PSEUDOEPHEDRINE HCL (MICROCAP), MANUFACTURED IN VANDALIA, OHIO ICN HUNGARY COMPANY LIMITED AVENTIS PHARMA DEUTSCHLAND GMBH BUSPIRONE BASE, MANUFACTURED IN TISZAVASVARI, HUNGARY GLYBURIDE [MILLED (GROUND)], MANUFACTURED IN FRANKFURT, FEDERAL REPUBLIC OF GERMANY 1-(MERCAPTOMETHYL) CYCLOPROPYLACETIC ACID, MANUFACTURED IN VISP, SWITZERLAND DROSPIRENONE, MANUFACTURED IN BERLIN, GERMANY CELSIS DIGITAL SYSTEM, MANUFACTURED IN CAMBRIDGE, UNITED KINGDOM URIDINE-5'-TRIPHOSPHATE (UTP), THERAPEUTIC GRADE; MANUFACTURED IN PENZBERG, GERMANY ESTRIOL, MANUFACTURED IN OSS, THE NETHERLANDS MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL RED CONCENTRATE (20PPP-681), MANUFACTURED IN ONTARIO, CANADA WHITE CONCENTRATE (10PPP-200), MANUFACTURED IN ONTARIO, CANADA PERMETHRIN, MANUFACTURED IN CONSHOHOCKEN, PA FLUOXETINE HCI, MANUFACTURED IN PETAH TIQVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD DIFENOXIN HCL, MANUFACTURED IN WEST DEPTFORD, NEW JERSEY ATENOLOL BULK DRUG, MANUFACTURED IN GUAYAMA, PR PROSOLVE SMCC (MICROCRYSTALLINE CELLULOSE, NF, JP, PH.EUR., BP AND COLLOIDAL SILICON DIOXIDE, NF, PH.EUR., BP), MANUFACTURED IN NASTOLA, FINLAND

HENRY H OTTENS MANUFACTURING CO INC ARTIFICIAL GRAPE FLAVOR #6175, MANUFACTURED IN PHILADELPHIA, PA

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4Q2012EXCEL DMF# 12151 I 12152 12153 12154 12155 12156 12157 12158 12159 12160 12161 I 12162 A 12163 I 12164 I 12165 I 12166 12167 12168 I 12169 12170 I 12171 12172 12173 12174 I 12175 12176 A 12177 12178 12179 12180 12181 I 12182 12183 A A II II 10/23/1996 10/21/1996 METABOLIC SOLUTIONS INC MALLINCKRODT INC I I I A I II II III II 10/17/1996 10/22/1996 10/22/1996 10/9/1996 10/24/1996 FUZHOU ANTIBIOTIC GENERAL FACTORY GANES CHEMICALS INC FARMHISPANIA SA MINNESOTA RUBBER AND PLASTICS NANOSYSTEMS A II IV 10/8/1996 10/16/1996 ISOCHEM CORDEN PHARMA SWITZERLAND LLC DOMIPHEN BROMIDE, MANUFACTURED IN GENNEVILLIERS, FRANCE A A A II II III II 10/11/1996 10/16/1996 10/9/1996 10/17/1996 ALBEMARLE CORP ALKALOIDA CHEMICAL CO ZRT RESCO COLOURS INC SCHERING PLOUGH AVONDALE CO A III II 10/11/1996 10/8/1996 AIRSEC SA SIGMA CHEMICAL CO A I II IV I 10/9/1996 10/11/1996 10/11/1996 DR REDDYS LABORATORIES LTD ICI KLEA AIRSEC SA II 10/7/1996 AVENTIS PHARMA DEUTSCHLAND GMBH IV 9/24/1996 BOEHRINGER INGELHEIM KG II 10/9/1996 CORTEX PHARMACEUTICALS INC II 10/8/1996 SUGAI CHEMICAL INDUSTRY CO LTD A I I I A I I I I II III I II II II II II III III 10/2/1996 9/24/1996 10/7/1996 10/3/1996 9/30/1996 10/2/1996 10/8/1996 10/8/1996 10/3/1996 11/1/1996 STATUS Type SUBMIT DATE I 10/1/1996 HOLDER GUANGDONG QINGYUAN NEW NORTH RIVER PHARMACEUTICAL CO LTD AVECIA BIOTECHNOLOGY INC 3M PHARMACEUTICALS INC PHYTOGEN LIFE SCIENCES INC TOYAMA CHEMICAL CO LTD BASF PHARMA EVIONNAZ SA NV ORGANON BACHEM INC RANBAXY INC ASAHI CHEMICAL INDUSTRY CO LTD WEDTECH INC SUBJECT MANUFACTURING FACILITIES FOR TOBRAMYCIN PHARMACEUTICAL CO., LTD. OLIGONUCLEOTIDES, MANUFACTURED IN MILFORD, MA COTRAN 9720 FILM, MANUFACTURED IN BROOKINGS, SD MANUFACTURING FACILITIES IN DELTA, BRITISH COLUMBIA, CANADA TKY-93 (INTERMEDIATE), MANUFACTURED IN GIFU, JAPAN

4Q2012

RIBAVIRIN, MANUFACTURED IN EVIONNAZ, SWITZERLAND AND ST-VULBAS, FRANCE MEGESTROL ACETATE, MANUFACTURED IN OSS, THE NETHERLANDS NBI-5788, MANUFACTURED IN TORRANCE, CALIFORNIA ACYCLOVIR DRUG SUBSTANCE, MANUFACTURED IN MADHYA PRADESH INDIA BARRIALON CX #24S, MANUFACTURED IN MIEPREFECTURE 513, JAPAN PRODUCT CODE 1006 WHITE FOR USE IN PACKAGING MATERIALS, MANUFACTURED IN ALBERTA AND ONTARIO, CANADA MONAL, 3-[2-(7-CHLOROQUINOLINY) ETHENYL]-BENZALDEHYDE, MANUFACTURED IN FUKUI, JAPAN AMPALEX, BULK PHARMACEUTICAL CHEMICAL (BPC), MANUFACTURED IN LAWRENCE, KANSAS COPOLYMERS OF TRIMETHYLENE CARBONATE WITHL- OR D,L-LACTIDE, MANUFACTURED IN INGELHEIM, GERMANY GLYBURIDE (MICRONIZED) BULK DRUG SUBSTANCE, MANUFACTURED IN FRANKFURT/MAIN FEDERAL REPUBLIC OF GERMAN RANITIDINE HDROCHLORIDE (FORM I), MANUFACTURED IN ANDHRA PRADESH , INDIA 1,1,1,2-TETRAFLUOROETHANE (ZEPHEX MDI), MANUFACTURED IN UNITED KINGDOM MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN ROMORANTIN, FRANCE DESICCATOR CAPSULES IN PE MANUFACTURED IN ROMORANTIN, FRANCE POLY-L-LYSINE HYDROCHLORIDE, SIGMA PRODUCT NUMBER P6837, MANUFACTURED IN ST. LOUIS, MISSOURI KETOCONAZOLE, MANUFACTURED IN SOUTH HAVEN, MI BUSPIRONE HYDROCHLORIDE; MANUFACTURED IN HUNGRY WHITE CONCENTRATE (O1EHD-415), MANUFACTURED IN ONTARIO, CANADA 5-(N,N-DIBENZYLGLYCYL) SALICYLAMIDE, MANUFACTURED IN CO WICKLOW, IRELAND

1,2-DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DMPC), MANUFACTURED IN LIESTAL, SWITZERLAND MANUFACTURING FACILITIES FOR GENTAMICIN SULFATE IN FUZHOU, P.R. CHINA NELFINAVIR, MANUFACTURED IN PENNSVILLE, NJ ASTEMIZOLE, MANUFACTURED IN BARCELONA, SPAIN C2512EJ ANFD C2512FV RUBBER COMPOUNDS, MANUFACTURED IN LITCHFIELD, MN TRIAMCINOLONE ACETONIDE NANOCRYSTAL COLLOIDAL DISPERSION, MANUFACTURED RESEARCH SERVICES, INC. IN HORSHAM, PA ERYTHROMYCIN BREATH TEST DOSE, MANUFACTURED IN MERRIMACK, NH SUFENTANIAL BASE CODE 0310 (ESUB) AS MANUFACTURED IN ST. LOUIS, MISSOURI Page 353

4Q2012EXCEL DMF# 12184 I 12185 12186 12187 I 12188 I 12189 I 12190 I 12191 12192 12193 I 12194 I 12195 12196 12197 I 12198 A 12199 I 12200 I 12201 12202 12203 12204 A 12205 I 12206 I 12207 12208 I 12209 I 12210 I II 11/12/1996 PG AMIDE II 11/8/1996 A II I 11/6/1996 11/1/1996 RANBAXY LABORATORIES LTD SHANGHAI NUMBER 16 PHARMACEUTICAL FACTORY TEVA GROUP V 11/4/1996 CORTEX PHARMACEUTICALS INC V 11/1/1996 CORTEX PHARMACEUTICALS INC A I I II II IV III 11/1/1996 10/25/1996 5/5/1996 10/28/1996 KANEKA CORP EURAND AMERICA INC TRICON VEREDLUNGS GMBH FLINT HILLS RESOURCES LP II 10/30/1996 INALCO SPA I 10/30/1996 INALCO SPA II 11/1/1996 DAINIPPON SUMITOMO PHARMA CO LTD A A II III I 10/31/1996 10/29/1996 10/30/1996 TAYCA CORP MULTISORB TECHNOLOGIES INC NOVOPHARM BIOTECH INC I 10/31/1996 TAYCA CORP I I II II III 10/25/1996 10/25/1996 10/22/1996 LIPOID GMBH LIPOID GMBH PHARMATUBE LTD III 10/21/1996 AMPACET CORP III 10/14/1996 AMPACET CORP III 10/18/1996 AMPACET CORP A I II II I 10/22/1996 10/24/1996 10/28/1996 AVANTI POLAR LIPIDS INC BACHEM CALIFORNIA FUJI CHEMICAL INDUSTRIES LTD TRIOCTANOIN, MANUFACTURED IN ALABASTER, ALABAMA T-20, MANUFACTURED IN TORRANCE, CALIFORNIA STATUS Type SUBMIT DATE I 10/21/1996 HOLDER NOVOPHARM QUEBEC SUBJECT

4Q2012

FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN QUEBEC, CANADA

MANUFACTURING, FACILITIES AND CONTROLS FOR GOHKAKIZAWA FACTORY IN TOYAMA, JAPAN 110409 WHITE POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA, AND MESSANCY, GE 110505 WHITE POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA, AND MESSANCY, GE 110375 WHITE POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA, AND MESSANCY, GE LIPOID PG 16:0/16:0, MANUFACTURED IN LUDWIGSHAFEN LIPOID PC 18:1/18:1, MANUFACTURED IN LUDWIGSHAFEN COLLAPSIBLE ALUMINIUM TUBE FOR PHARMACEUTICALS, MANUFACTURED IN MANCHESTER ENGLAND MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATINGPROCEDURES, A THE OKAYAMA PLANT IN OKAYAMA, JAPAN MICRO TITANIUM DIOXIDE MT SERIES, MANUFACTURED IN OKAYAMA, JAPAN SORBICAP, MANUFACTURED IN BUFFALO, NEW YORK MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN WINNIPEG MANITOBA, CANADA ZONISAMIDE DRUG SUBSTANCE, MANUFACTURED AT IT'S SUZUKA FACTORY IN MIE, JAPAN MANUFACTURING SITES, FACILITIES, PERSONNEL AND OPERATING PROCEDURES AT R S M S.R.L. IN PISTOIA, ITALY 2,3 DI-O-BENZYL 4,6-O-ETHYLIDENE-D-GLUCOPYRANOSIDE (DBEG), MANUFACTURED BY RICERCHE SPERIMENTALI MONTALE IN MONTALE, ITALY PCE, MANUFACTURED IN OSAKA, JAPAN MICROCAPS PHENYLPROPANOLAMINE HC1, USP MANUFACTURED IN VANDALIA, OHIO PET FILM 100 MICRON WITH LOGO PRINTING, MANUFACTURED IN FREIBURG, GERMANY POLYPROPYLENE AS A PACKAGING MATERIAL, MANUFACTURED IN LONGVIEW, TX, MARYSVILLE, MI AND WOODBURY, NJ AMPALEX TM, PRIOR CLINICAL STUDIES, BY CORTEX PHARMACEUTICALS, INC. IN IRVINE, CALIFORNIA AMPALEX TM, PRE-CLINICAL STUDIES , BY CORTEX PHARMACEUTICALS, INC. IN IRVINE, CALIFORNIA RANITIDINE HYDROCHLORIDE (FORM I), MANUFACTURED IN PUNJAB, INDIA MANUFACTURING SITES, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN SHANGHAI, P.R. CHINA ACYCLOVIR USP, MANUFACTURED A ASSIA CHEMICAL INDUSTRIES LTD. IN TIQVA, ISRAEL D-(-)-PHENYLGLYCINAMIDE (FG-AMIIDE), MANUFACTURED IN VENLO, THE NETHERLANDS

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4Q2012EXCEL DMF# 12211 I 12212 12213 12214 12215 12216 12217 I 12218 II 11/12/1996 NIPPON SODA CO LTD I I A I A III III II III III II 11/5/1996 11/6/1996 10/25/1996 10/28/1996 10/28/1996 11/14/1996 STATUS Type SUBMIT DATE II 11/11/1996 HOLDER RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA CKS PACKAGING INC OY PREMIX LTD CKD BIO CORP CODING PRODUCTS CODING PRODUCTS SUBJECT IOPAMIDOL, MANUFACTURED IN LATINA, ITALY

4Q2012

HIGH DENSITY POLYETHLENE PLASTIC CONTAINERS, MANUFACTURED IN ALANTA, GA PRE-ELEC PP 1381, MANUFACTURED IN RAJAMAKI, FINLAND CYCLOSPORINE, NON-STERILE BULK, USP MANUFACTURED IN SEOUL, KOREA SV-59122, HOT STAMP INK RIBBON, MANUFACTURED IN KALKASKA, MI SV-16848, HOT STAMP INK RIBBON, MANUFACTURED IN KALKASKA, MI

FARCHEMIA SRL DIV TESSENDERLO CHEMIE DICLOFENAC POTASSIUM, MANUFACTURED IN BERGAMO, ITALY 4-NITROBENZYL (4R,5R,6S)-3-DIPHENYLPHOSPHORYLOXY-6-[(R)-1-HYDROXYETHYL]-4METHYL-7-OXO-1-AZABICYCLO[3.2.0.] HEPT-2-ENE-2-CARBOXYLATE (CODE NAME MAP), A BULK CHEMICAL DRUG SUBSTANCE INTERMEDIATE, MANUFACTURED IN TOYAMA, JAPAN 11233 WHITE POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA AND MESSANCY, GE BIO-PSA STANDARD SILICONE PRESSURE SENSITIVE ADHESIVES, MANUFACTURED IN HEMLOCK, MI 48626 FLUOXETINE HYDROCHORIDE, MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND MANUFACTURING FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN HEMER, GERMANY MISTETTE MARK II AND MK SPRAYER MEDICAL DEVICE MANUFACTURED IN HEMER, GERMANY SULINDAC, ACCORDING TO USP 23 AND BP 1993, MANUFACTURED IN LODI, ITALY TEFLON TOPCOAT 3200-100, MANUFACTURED IN PARLIN, NJ COTTON, RAYON, POLYESTER COILER, MANUFACTURED IN RENO, NV N-BENZYL-4-FORMYLPIPERIDINE, MANUFACTURED IN SAITAMA, JAPAN ESTAZOLAM, MANUFACTURED IN MILAN, ITALY PENTAACETYLIOPAMIDOL INTERMEDIATE, MANUFACTURED IN FROSINONE, ITALY PSEUDOEPHEDRINE HYDROCHLORIDE, MANFACTURED A XINJIANG HESHUO EPHEDRINE FACTORY IN HESHUO XINJIANG, CHINA CLADRIBINE, MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND MICROPUMPS, MANUFACTURED IN MEZZOVICO, SWITZERLAND 1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOGLYCEROL, SODIUM SALT (DSPG, NA), MANUFACTURED IN LIESTAL, SWITZERLAND TIMOLOL MALEATE, MANUFACTURED IN RADEBEUL, GERMANY PEG TELOMER B, MANUFACTURED IN SHEBOYGEN FALLS, WI PRODUCT CODE 1004 WHITE, MANUFACTURED IN ALBERTA AND ONTARIO, CANADA COMPAP WSE, CODE 2907 (ESUB) AS MANUFACTURED IN GREENVILLE, ILLINOIS PEMOLINE, MANUFACTURED IN CORPUS CHRISTI, TEXAS COLLAPSIBLE ALUMINIUM TUBES, MANUFACTURED IN BISSINGEN, GERMANY ESERETHOL, MANUFACTURED IN BARCELONA, SPAIN DEFEROXAMINE MESYLATE, MANUFACTURED AT BIOGAL PHARMACEUTICAL WORKS LTD IN DEBRECEN, HUNGARY DIPIVEFRIN HYDROCHLORIDE, MANUFACTURED IN TURKU, FINLAND Page 355

I 12219 I 12220 A 12221 12222 I 12223 A 12224 12225 12226 12227 12228 12229 12230 I 12231 12232 12233 A 12234 12235 12236 12237 12238 12239 12240 12241 A 12242 I II 12/2/1996 PCAS FINLAND OY I I I A I I I II II III II II III II II 11/22/1996 11/20/1996 11/25/1996 11/18/1996 12/5/1996 11/11/1996 11/20/1996 12/2/1996 DEGUSSA AG WERK RADEBEUL ALDRICH CHEMICAL CO INC WEDTECH INC MALLINCKRODT INC HOECHST CELANESE CORP A KIENZLE GMBH AND CO KG BOEHRINGER INGELHEIM ESPANA SA TEVA PHARMACEUTICAL INDUSTRIES LTD I I II III IV 11/21/1996 11/19/1996 11/22/1996 A I I I A I II III III II II II II 11/15/1996 11/13/1996 11/5/1996 5/17/1996 11/18/1996 11/13/1996 11/18/1996 SIFAVITOR SRL DUPONT CO NEVEETI INDUSTRIES LLC KAWAKEN FINE CHEMICALS CO LTD CAMBREX PROFARMACO MILANO SRL CHEMI SPA XINJIANG HESHUO PHARMACEUTICAL COMPLEX CILAG AG VALOIS DISPRAY CORDEN PHARMA SWITZERLAND LLC III 11/16/1996 MWV CALMAR GMBH I II I 11/15/1996 11/16/1996 CILAG AG CALMAR ALBERT GMBH IV 10/31/1996 DOW CORNING CORP III 11/11/1996 AMPACET CORP

4Q2012EXCEL DMF# 12243 A 12244 12245 I 12246 12247 12248 12249 12250 12251 12252 12253 12254 12255 12256 12257 I 12258 I 12259 A 12260 A 12261 12262 A 12263 12264 12265 I 12266 I 12267 12268 12269 12270 12271 12272 I 12273 12274 12275 A I I II II II 12/17/1996 12/13/1996 12/17/1996 CAMBREX PROFARMACO MILANO SRL SANKYO CO LTD JANSSEN PHARMACEUTICA NV A A A I I II II II II II II 12/11/1996 12/16/1996 12/16/1996 11/22/1996 12/16/1996 12/6/1996 SANOFI CHIMIE NV ORGANON TEVA PHARMACEUTICAL INDUSTRIES LTD KYOWA HAKKO KOGYO CO LTD AKZO NOBEL CHEMICALS BV AVENTIS PHARMA DEUTSCHLAND GMBH IV 12/3/1996 JANSSEN BIOTECH NV A N I 12/11/1996 II 9/24/1996 I III II 12/10/1996 12/11/1996 II 12/11/1996 II 12/6/1996 I 12/6/1996 I I A A I I I I I I I I II II III III III III III III III III II 11/25/1996 12/3/1996 12/4/1996 8/14/1996 8/14/1996 9/27/1996 8/14/1996 8/14/1996 8/14/1996 8/14/1996 8/14/1996 12/9/1996 PET PARTNERS BV GUANDONG PHARMACEUTICAL FACTORY ESTEVE QUIMICA SA COLORS FOR PLASTICS INC COLORS FOR PLASTICS COLORS FOR PLASTICS COLORS FOR PLASTICS COLORS FOR PLASTICS COLORS FOR PLASTICS COLORS FOR PLASTICS COLORS FOR PLASTICS H LUNDBECK AS I II III 11/25/1996 11/25/1996 BASF PHARMACHEMIKALIEN GMBH CO KG PET PARTNERS BV STATUS Type SUBMIT DATE IV 12/6/1996 HOLDER MITSUI CHEMICALS INC SUBJECT

4Q2012

PLGA75, POLY(DL-LACTIDE-CO-GLYCOLIDE), MANUFACTURED AT NAGOYA FACTORY IN NAGOYA CITY, JAPAN TERAZOSIN HYDROCHLORIDE, MANUFACTURED IN LUDWIGSHAFEN, GERMANY CLEAR PET BOTTLES AND AMBER PET BOTTLES, MANUFACTURED IN THE NETHERLANDS MANUFACTURING SITES, PERSONNEL AND GENERAL OPERATING PROCEDURES SULFADIMETHOXINE SODIUM, MANUFACTURED IN GUANGZHOU, CHINA FELODIPINE, MANUFACTURED IN BARCELONA SPAIN B18196, MANUFACTURED IN ELK GROVE, IL B18215, MANUFACTURED IN ELK GROVE, IL E11690, MANUFACTURED IN ELK GROVE, IL E11757, MANUFACTURED IN ELK GROVE, IL E11706,MANUFACTURED IN ELK GROVE, IL N04859, MANUFACTURED IN ELK GROVE, IL N04841, MANUFACTURED IN ELK GROVE, IL W06219, MANUFACTURED IN ELK GROVE, IL

LU-25-109-M DRUG SUBSTANCE, MANUFACTURED IN LEVERKUSEN, GERMANY AND ZOFINGEN, SWITZERLAND MALLINCKRODT MEDICAL IMAGING IRELAND MANUFACTURING SITES, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN DUBLIN, IRELAND MALLINCKRODT INC IOVERSOL, DRUG SUBSTANCE FOR OPTIRAY (ESUB) AS MANFACTURED IN DUBLIN, IRELAND RELIABLE BIOPHARMACEUTICAL CORP PHENTOLAMINE MESYLATE, USP A BULK PHARMACEUTICAL, MANUFACTURED IN ST. LOUIS, MISSOURI BOSTIK INC POLYMERIC ADHESIVE, MANUFACTURED IN MIDDLETON, MA CHONGQING CARE LIFE PHARMACEUTICAL CO LTD WUXI KAILI PHARMACEUTICAL CO LTD NOT AN ASSIGNED NUMBER RP SCHERER MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN BEIHEM, FRANCE HYDROXYPROPYL-BETA-CYCLODEXTRIN, (ENCAPSIN HPB), MANUFACTURED IN OLEN, BELGIUM TRIMEGESTONE, MANUFACTURED IN NEUVILLE, FRANCE ESTRADIOL VALERATE, MANUFACTURED IN OSS, THE NETHERLANDS WARFARIN SODIUM CLATHRATE, MANUFACTURED IN BRNO, CZECH REPUBLIC BUCILLAMINE BULK SUBSTANCE, MANUFACTURED IN OSAKA PREFECTURE, JAPAN HALAMID PHARMA GRADE, MANUFACTURED IN AMSTERDAM, THE NETHERLANDS BULK PROTIRELIN (THYROID RELEASING HORMONE; TRH) DRUG SUBSTANCE, MANUFACTURED IN FRANKFURT, GERMANY SOTALOL HCL, MANUFACTURED IN MILANO, ITALY CS-834 DRUG SUBSTANCE, MANUFACTURED IN KANAGAWA, JAPAN LIAROZOLE FUMERATE DRUG SUBSTANCE, MANUFACTURED IN GEEL, BELGIUM MITOXANTRONE HYDROCHLORIDE USP, MANUFACTURED IN SICHUAN, CHINA CIMETIDINE, MANUFACTURED IN JIANGSU PROVINCE, CHINA

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4Q2012EXCEL DMF# 12276 12277 12278 I 12279 12280 A 12281 A 12282 I 12283 12284 12285 I 12286 12287 12288 12289 12290 12291 12292 12293 12294 12295 A 12296 12297 I 12298 12299 A 12300 12301 12302 I 12303 I 12304 I 12305 12306 A I IV III 12/27/1996 8/31/1996 BOC GROUP INC THE BOC GASES IRIS LTD DIV ARCO BEAUTY LTD II 1/3/1997 SIGMA CHEMICAL CO IV 12/16/1996 I I III III V 12/24/1996 12/31/1996 1/2/1997 ALVEO AG BAG PACK INC DRUG DEVELOPMENT OFFICE CANCER RESEARCH CAMPAIGN RHONE POULENC INC I III IV 12/10/1996 12/20/1996 OWENS ILLINOIS INC BLANVER FARMOQUIMICA LTDA COMPRESSION MOLDED CLOSURES, MANUFACTURED IN ERIE, PA A II II 12/23/1996 12/27/1996 CHEMI SPA BACHEM CALIFORNIA A A I I I A I A A II II II II V II II II II II 12/19/1996 12/20/1996 12/23/1996 12/18/1996 12/19/1996 12/18/1996 12/23/1996 12/24/1996 12/27/1996 12/30/1996 EXCELLA GMBH SA AJINOMOTO OMNICHEM NV BACHEM CALIFORNIA COURTAULDS CHEMICALS BIODOME QUIMICA SINTETICA SA INDUSTRIALE CHIMICA SRL NV ORGANON SERIPHARM SA VIFOR INTERNATIONAL INC I I II I I 12/20/1996 12/19/1996 12/23/1996 III 12/10/1996 II 8/28/1996 I II II 12/12/1996 12/12/1996 STATUS Type SUBMIT DATE I I II II I 12/13/1996 12/16/1996 12/13/1996 HOLDER SANKYO CO LTD ROCHE DIAGNOSTICS GMBH SHANGHAI NUMBER 1 PHARMACEUTICAL FACTORY UNION QUIMICO FARMACEUTICA SA SUBJECT CS-834 DRUG PRODUCT, MANUFACTURED IN TOKYO, JAPAN 5-BROMO-2'-DEOXYURIDINE, MANUFACTURED IN MANNHEIM, GERMANY

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN SHANGHAI, CHINA PENTAACETYLIOPAMIDOL, MANUFACTURED IN BARCELONA, SPAIN

UNION QUIMICO FARMACEUTICA SA UQUIFA IOPAMIDOL STEP #1, MANUFACTURED IN BARCELONA, SPAIN SA SHANGHAI NUMBER 1 BIOCHEMICAL AND HEPARIN SODIUM, MANUFACTURED IN SHANGHAI, CHINA PHARMACEUTICAL CO CARCANO ANTONIO S.P.A. ALUMINIUM FOIL, SMOOTH, SOFT TEMPER, 0.045 MM, LACQUERED FOR PRINTING ON ONE SIDE AND LAMINATED WITHADHESIVE TO POLYETHYLENE FILM 0.020 MM ON THE OTHER SIDE, MANUFACTURED IN DEL LARIO-LC-ITALY NANOSYSTEMS BIODOME BAYER DE MEXICO SA DE CV MK-639 NANOCRYSTAL, MANUFACTURED BY PMRS IN HORSHAM, PA MANUFACTURING SITES, FACILITIES, AND PERSONNEL IN CEDEX, FRANCE MANUFACTURING SITES, FACILITIES, OPERATING PROCEDURES, AND PERSONNEL IN DELEGACION MIGUEL HIDALGO, MEXICO FLUNIXIN MEGLUMINE, MANUFACTURED IN FEUCHT, GERMANY BALSALAZIDE DISODIUM, MANUFACTURED IN WETTEREN, BELGIUM IB-367, MANUFACTURED IN SAN DIEGO, CALIFORNIA BALSALAZIDE DISODIUM, MANUFACTURED IN FIFE SCOTLAND BIOSET INFUSION, IN CEDEX, FRANCE FLUOXETINE HYDROCHLORIDE, MANUFACTURED IN MADRID, SPAIN FLUOXETINE HYDROCHLORIDE, MANUFACTURED IN SARONNO, ITALY ETONOGESTREL, MANUFACTURED IN OSS, THE NETHERLANDS PACLITAXEL, MANUFACTURED IN LE MANS, FRANCE DEXFER HUMAN USA (IRON DEXTRAN POWDER), MANUFACTURED IN ST. GALLEN, SWITZERLAND NABUMETONE, MANUFACTURED IN FROSINONE, ITALY GLUCAGON (1-29), HUMAN, MANUFACTURED IN TORRANCE AND SAN DIEGO, CALIFORNIA

CELLULOSE, MICROCRYSTALLINE AND CARBOXYMETHYLCELLULOSE SODIUM NF, MANUFACTURED IN ITAPEVI-SP-BRAZIL ALVEOLIT TEE 0500 WHITE, MANUFACTURED IN LUZERN, SWITZERLAND BOTTOM SEAL POLY BAGS, MANUFACTURED IN CINCINNATI, OHIO BACKGROUND, PERSONNEL AND PROCEDURES FOR DEVELOPMENT OF NEW ANTICANCER AGENTS IN UNITED KINGDOM IGEPAL CA 630 SPECIAL (OCTOXYNOL-9), MANUFACTURED IN SPARTANBURG, SOUTH CAROLINA PHLORIDZIN FROM APPLE SIGMA PRODUCT NO. P0289, MANUFACTURED IN ST. LOUIS, MO EXCIPIENT, LIQUEFIED NITROGEN, MANUFACTURED IN TERRELL, TEXAS SURGICAL COIL 100% COTTON AND 100% RAYON-PHARMACEUTICAL GRADE, MANUFACTURED IN MONTREAL, QUEBEC, CANADA

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4Q2012EXCEL DMF# 12307 I 12308 12309 12310 I 12311 12312 12313 12314 12315 12316 12317 12318 12319 12320 I 12321 12322 A 12323 A 12324 I 12325 I 12326 12327 A 12328 A 12329 A 12330 I 12331 12332 12333 I 12334 12335 12336 I I I II III III 1/24/1997 1/27/1997 1/27/1997 PT SIKONA INDONESIA LESTARI THE WEST COMPANY INC TETRAFLUOR INC QUINIDINE GLUCONATE, MANUFACTURED IN CIATER, WEST JAVA, INDONESIA MERCURY BOTTLE ASSEMBLY, MANUFACTURED IN LIONVILLE, PA I I II II III 1/23/1997 1/23/1997 1/23/1997 III 1/6/1997 PRECISE PRODUCTS AND DEVELOPMENT CORPORATION GANES CHEMICALS INC NV ORGANON TAYLOR WHARTON IV 1/16/1997 FMC CORP FMC BIOPOLYMER DIV II 1/20/1997 IDT AUSTRALIA LTD I II II 1/14/1997 1/21/1997 UNION QUIMICO FARMACEUTICA SA CATALENT PHARMA SOLUTIONS LLC AG 1346, MANUFACTURED IN BARCELONA, SPAIN III 1/15/1997 III 1/17/1997 III 12/4/1996 A III IV 1/16/1997 1/7/1997 BAYER MATERIALSCIENCE LLC DOW CORNING CORP I I I I I I I A I III III II III III III III III III II 12/16/1996 12/16/1996 1/13/1997 12/11/1996 12/11/1996 12/11/1996 11/21/1996 12/10/1996 12/10/1996 12/30/1996 BASELL POLIOLEFINE ITALIA SPA BASF AKTIENGESELLSCHAFT ANTIBIOTIC CO SOLVIN SA SOLVAY SA SOLVIN SA SOLVAY SA SOLVAY SA SOLVIN SA DOTTIKON EXCLUSIVE SUNTHESIS AG I A II II II 1/10/1997 1/9/1997 1/6/1997 CHANGZOU SYNTHETIC MATERIAL PLANT SYNKEM SAS TAKASAGO INTL CORP STATUS Type SUBMIT DATE I 1/6/1997 HOLDER TAKASAGO INTL CORP SUBJECT

4Q2012

MANUFACTURING SITES, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES A FINE CHEM CO., LTD. IN OGASA-GUN, JAPAN FOR (R)-4MERCAPTOPYRROLIDIN-2-ONE, OR (R) ALBENDAZOLE, MANUFACTURED IN NIUTANG TOEN CHANGZOU CITY JIIANGSU, CHINA OXYBUTYNIN HYDROCHLORIDE, MANUFACTURED IN CEDEX, FRANCE (R)-4-MERCAPTOPYRROLIDIN-2-ONE, OR (R)-MPD, MANUFACTURED BY FINE CHEM CO., LTD. A OGASA-GUN, JAPAN LUPOLEN 2426 F, MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY LUPOLEN 1804 H, MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY STERILE SULBACTAM SODIUM, MANUFACTURED IN RAZGRAD, BULGARIA IXAN PVDC WA 36, MANUFACTURED IN TAVAUX CEDEX, FRANCE IXAN PVDC PA 120, MANUFACTURED IN TAVAUX CEDEX, FRANCE IXAN PVDC WA 63, MANUFACTURED IN TAVAUX CEDEX, FRANCE IXAN PVDC PA 344, MANUFACTURED IN TAVAUX CEDEX, FRANCE IXAN PVDC PA 331, MANUFACTURED IN TAVAUX CEDEX, FRANCE IXAN PVDC WA 50, MANUFACTURED IN TAVAUX CEDEX, FRANCE 6.7-DIHYDRO-3-ETHYL-2-METHYLINDOL-4-ONE (EMOTI), MANUFACTURED IN DOTTIKON, SWITZERLAND MAKROLON 2458-FBL, MANUFACTURED IN KREFELD-VERDINGEN, GERMANY

BIO-PSA AMINE-COMPATIBLE HOT MELT SILICONE PRESSURE SENSITIVE ADHESIVES, MANUFACTURED IN HEMLOCK, MI NAN YA PLASTICS CORPORATION AMERICA TAIRILIU COPOLYMER PET, MANUFACTURED IN LAKE CITY, SOUTH CAROLINA SOUTH CAROLINA PLANT BASF AKTIENGESELLSCHAFT BASONA F DS 3425, MANUFACTURED IN SCHWARZHEIDE, FEDERAL REPUBLIC OF GERMANY TUBCOR SA COLLAPSIBLE ALUMINIUM TUBE, MANUFACTURED IN VILAFRANCA DEL PENEDES, SPAIN

BENZONATATE 100 MG AND 200 MG SOFTGEL CAPSULES AS MANUFACTURED IN ST. PETERSBURG FL MITOXANTRONE HYDROCHLORIDE USP, MANUFACTURED IN BORONIA VICTORIA, AUSTRALIA AVICEL RC/CL MICROCRYSTALLINE CELLULOSE AND CARBOXYMETHLCELLULOSE SODIUM, MANUFACTURED IN NEWARK, DELAWARE AND CORK, IRELAND BOTTLE PLUG AND DIP TUBE ASSEMBLY DWG NO. P9601-05 REV. A., MANUFACTURED IN MIDDLESEX, NJ R-NORSELEGILINE BASE AND HYDROCHLORIDE, MANUFACTURED IN PENNSVILLE, NJ NORGESTOMET, MANUFACTURED IN OSS, THE NETHERLANDS SEAMLESS STEEL COMPRESSED GAS CYLINDERS, MANUFACTURED IN HARRISBURG, PA

TEFLON O-RING GASKET FOR COMPRESSED GAS CYLINDER, MANUFACTURED IN EL SEGUNDO, CA

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4Q2012EXCEL DMF# 12337 A 12338 12339 A 12340 12341 12342 12343 12344 I 12345 I 12346 12347 12348 12349 12350 12351 I 12352 I 12353 I 12354 I 12355 12356 C 12357 12358 A 12359 I 12360 12361 12362 A 12363 I 12364 I 12365 I III 2/11/1997 II 2/13/1997 I 2/10/1997 INDUSTRIALE CHIMICA SRL I I II II III 1/31/1997 1/31/1997 2/10/1997 EURAND AMERICA INC EURAND AMERICA INC SOLVIN SA III 2/11/1997 AMPACET CORP I II III 2/11/1997 1/30/1997 VICKSBURG CHEMICAL CO SHERWOOD VALVE LLC A II II 1/31/1997 2/4/1997 II 2/3/1997 II 2/4/1997 II 2/6/1997 A I A I I II III II II II I 1/29/1997 1/16/1997 1/31/1997 2/5/1997 2/3/1997 2/2/1997 ZACH SYSTEM 3M ANTIBIOTICOS SA TASMANIAN ALKALOIDS PARTY LTD EGIS PHARMACEUTICALS PUBLIC LTD CO ROLABO SL III 1/8/1997 A A A A II II II V V 1/24/1997 1/28/1997 1/28/1997 1/2/1997 1/27/1997 I IV III 1/23/1997 1/7/1997 ARYLESSENCE INC GEORGIA GULF CHEMICALS AND VINYLS LLC FARCHEMIA SRL DR REDDYS LABORATORIES LTD DR REDDYS LABORATORIES LTD STELMI SA NATIONAL INSTITUTES HEALTH NATIONAL CANCER INSTITUTE CREST FLEXIBLE PACKAGING LTD STATUS Type SUBMIT DATE III 1/23/1997 HOLDER LUXFER GAS CYLINDERS SUBJECT

4Q2012

HIGH PRESSURE ALUMINUM COMPRESSED GAS CYLINDERS, MANUFACTURED IN RIVERSIDE, CA ARYLESSENCE 00798 N AND A CHERRY FLAVOR, MANFACTURED IN MARIETTA, GA PVC COMPOUND, 8272 WHITE 344, MANUFACTURED IN TIPTONVILLE, TN OXAPROZIN, MANUFACTURED IN TREVIGLIO (BERGAMO), ITALY NAPROXEN, MANUFACTURED IN ANDHRA PRADESH, INDIA NAPROXEN SODIUM, MANUFACTURED IN ANDHRA PRADESH, INDIA ULTRACLEAN-6 WASHING PROCESS, MANUFACTURED IN GRANVILLE, FRANCE PRECLINICAL TOXICOLOGY DATA FOR THE AGENT ECTEINASCIDIN 743 IN BETHESDA, MD PACKAGING MATERIALS AND MEDICAL PACKAGING (POLYESTER/ADHESIVE/ALUMINIUM FOIL/ADHESIVE/POLYETHYLENE), MANUFACTURED IN KENT, ENGLAND VENLAFAXINE HYDROCHLORIDE, MANUFACTURED IN AVRILLE CEDEX, FRANCE 3M SCOTCHPAK 96 FILM, MANUFACTURED IN ST. PAUL, MN 6-AMINO PENICILLANIC ACID, MANUFACTURED IN LEON, SPAIN NALTREXONE BENZOATE, MANUFACTURED IN WESTBURY, TASMANIA, AUSTRALIA BUSPIRONE HYDROCHLORIDE USP BULK, MANUFACTURED IN BUDAPEST, HUNGARY MANUFACTURING SITES, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN ZARAGOZA, SPAIN RIFAXIMIN, MANUFACTURED IN FREEPORT, GRAND BAHAMA ISLAND

PHARMACEUTICAL FINE CHEMICALS BAHAMAS VIS FARMACEUTICI INSTITUTO SCIENTIFICO FLUVOXAMINE MALEATE, MANUFACTURED IN PADOVA, ITALY VINEZIE SPA VIS FARMACEUTICI INSTITUTO SCIENTIFICO ETIDRONATE DISODIUM, MANUFACTURED IN PADOVA, ITALY VINEZIE SPA ROHM AND HAAS CO AMBERLITE IRP69, MANUFACTURED IN CHAUNY CEDEX, FRANCE DIVIS LABORATORIES LTD

DEXTROMETHORPHAN HYDROBROMIDE USP, MANUFACTURED IN ANDHRA PRADESH, INDIA POTASSIUM NITRATE USP GRADE, MANUFACTURED IN VICKSBURG, MS COMPRESSED CYLINDER GAS VALVES, SERIES 6074X, MANUFACTURED IN WASHINGTON, PA 160325 BLUE UV POLYETHYLENE MASTERBACH, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA, AND MESSANCY, GE MICROCAPS DIPHENHYDRAMINE CITRATE, MANUFACTURED IN VANDALIA, OHIO MICROCAPS CIMETIDINE, USP, MANUFACTURED IN VANDALIA, OH SOLVIN 257 RF MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN SARONNO, ITALY OMAN CHEMICALS AND PHARMACEUTICALS 6-AMINO PENICILLANIC ACID, MANUFACTURED IN AL BURAIMI, SULTANATE OF OMAN LLC FLEX INDUSTRIES LIMITED POLYESTER FILM (BIAXIALLY ORIENTED), MANUFACTURED IN GHAZIABAD, INDIA

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4Q2012EXCEL DMF# 12366 I 12367 I 12368 12369 12370 I 12371 12372 12373 I 12374 12375 12376 12377 A 12378 I 12379 12380 12381 I 12382 I 12383 I 12384 A 12385 12386 12387 I 12388 12389 I 12390 12391 I 12392 I 12393 I 12394 I II 2/26/1997 CUNO EUROPE SA II 2/26/1997 CUNO EUROPE SA II 2/26/1997 CUNO EUROPE SA I II II 2/26/1997 2/26/1997 A II II 2/21/1997 2/26/1997 IWAKI SEIYAKU CO LTD A I II II I 2/21/1997 2/27/1997 2/21/1997 BASF PHARMACHEMIKALIEN GMBH CO KG SOLVAY DUPHAR BV IWAKI SEIYAKU CO II 2/24/1997 H LUNDBECK AS I 2/24/1997 H LUNDBECK AS I 2/24/1997 H LUNDBECK AS A A II II I 2/19/1997 2/24/1997 2/24/1997 AJINOMOTO CO INC ASTELLAS PHARMA INC H LUNDBECK AS III 3/3/1997 A A I II III III V 2/24/1997 2/18/1997 2/12/1997 2/24/1997 USV LIMITED BASF CORP DANAPAK FLEXIBLES NATIONAL INSTITUTES HEALTH NATIONAL INSTITUTE ALLERGY AND INFECTIOUS DISEASES 4P VERPACKUNGEN RONSBERG GMBH I A I IV I 2/24/1997 2/11/1997 2/24/1997 NOVOCOL PHARMACEUTICAL CANADA INC MANTROSE HAEUSER CO INC USV LTD A I II II III 2/18/1997 2/21/1997 2/18/1997 GEDEON RICHTER PLC DEGUSSA AG POLYMER COLOR INC DESOGESTREL, MANUFACTURED IN BUDAPEST, HUNGARAY CARBOPLATIN, USP, MANUFACTURED IN HANAU, GERMANY II 2/5/1997 STATUS Type SUBMIT DATE II 2/5/1997 HOLDER SUBJECT

4Q2012

MATERIALS PROCESSING TECHNOLOGY INC DIRECTLY COMPRESSIBLE ACETAMINOPHEN DC-90B, MANUFACTURED IN PATERSON, NJ MATERIALS PROCESSING TECHNOLOGY INC DIRECTLY COMPRESSIBLE ACETAMINOPHEN DC-90A, MANUFACTURED IN PATERSON, NJ

GLC-18713 25/1 TURQUOISE COLOR CONCENTRATE, MANUFACTURED IN MCHENRY, ILLINOIS AUTOINJECTOR PRODUCTION, MANUFACTURED IN CAMBRIDGE, ONTARIO CERTISEAL FC-300A, MANUFACTURED IN ATTLEBORO, MA MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN MAHARASHTRA, INDIA GLIPIZIDE, MANUFACTURED IN MAHARASHTRA, INDIA GLEITMITTELDISPERSION 8645, MANUFACTURED IN LUDWIGSHAFEN, GERMANY PHARMACEUTICAL COMPONENT, MANUFACTURED IN ODENSE, DENMARK DAIDS POLICIES AND PROCEDURES PERTAINING TO CLINICAL TRIALS CONDUCTED UNDER DAIDS-SPONSORED INDS FLEXIBLE LAMINATE FOR TUBE PRODUCTION, MANUFACTURED IN RONSBERG, FEDERAL REPUBLIC OF GERMANY LEVODOPA, MANUFACTURED IN KANAGAWA, JAPAN FORMOTEROL FUMARATE, MANUFACTURED IN IBARAKI-KEN, JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN VALBY, DENMARK MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN SEAL SANDS, UNITED KINGDOM MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN LAMSAS, DENMARK CITALOPRAM HYDROBROMIDE, MANUFACTURED IN LUMSAS AND VALBY, DENMARK AND SEAL SANDS, UNITED KINGDOM SELEGILINE, MANUFACTURED IN MINDEN, GERMANY CALCIFEDIOL, MANUFACTURED IN WEESP, THE NETHERLANDS MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES AT THE SHIZUOKA FACTORY IN SHIZUOKA, JAPAN PILOCARPINE HYDROCHLORIDE, MANUFACTURED IN SHIZUOKA, JAPAN

SHANDONG LUKANG PHARMACEUTICAL CO PENICILLIN G POTASSIUM (CRUDE), MANUFACTURED IN SHANDONG PROVINCE, CHINA LTD CUNO EUROPE SA ZETA-PLUS LP AND LPM SERIES, MANUFACTURED IN MAZERES SUR SALA, FRANCE CUNO EUROPE SA ZETACARBON R.1SP AND SLP SERIES, MANUFACTURED IN MAZERES SUR SALAT, FRANCE ZETACARBON R.2SP AND SLP SERIES, MANUAFCTURED IN MAZERES SUR SALAT, FRANCE ZETACARBON R.3SP AND SLP SERIES, MANUAFCTURED IN MAZERES SUR SALAT, FRANCE ZETA PLUS SP SERIES, MANUFACTURED IN MAZERES SUR SALA, FRANCE Page

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4Q2012EXCEL DMF# 12395 I 12396 I 12397 12398 I 12399 12400 12401 12402 I 12403 I 12404 12405 12406 A 12407 12408 I 12409 I 12410 I 12411 12412 12413 12414 12415 12416 I 12417 A 12418 12419 12420 12421 A 12422 12423 I 12424 I II 3/17/1997 BIOINDUSTRIA A V II 3/7/1997 2/15/1997 STERIGENICS INTERNATIONAL INC CKD BIO CORPORATION STERILIZATION FACILITY IN GURNEE, IL I A I II II II II 3/1/1997 3/17/1997 3/18/1997 3/14/1997 OTSUKA PHARMACEUTICAL CO LTD AMRI RENSSELAER INC KYOWA HAKKO KOGYO CO LTD NOVARTIS PHARMACEUTICALS CORP II 3/14/1997 TEVA PHARMACEUTICAL INDUSTRIES LTD I A I I I II II III III III II 3/10/1997 3/10/1997 2/7/1997 2/7/1997 1/31/1997 3/14/1997 BACHEM CALIFORNIA RECKITT BENCKISER HEALTHCARE UK LTD VALSPAR CORP VALSPAR CORP BASF AKTIENGESELLSCHAFT JANSSEN PHARMACEUTICA NV V 2/28/1997 CIBA VISION STERILE MANUFACTURING III 3/6/1997 AMPACET CORP I III III 2/26/1997 3/6/1997 INTERNATIONAL GROUP INC AMPACET CORP I A II II IV 2/28/1997 3/5/1997 3/5/1997 ZENTIVA, A.S. TEVA PHARMACEUTICAL INDUSTRIES LTD FMC CORP FMC BIOPOLYMER DIV II 3/4/1997 YAMASA CORP I I I II II II I 2/26/1997 3/2/1997 3/5/1997 3/5/1997 CUNO EUROPE SA ZHEJIANG RUIBANG LABORATORIES SELOC FRANCE AJANTA PHARMA LIMITED I II II 2/26/1997 2/26/1997 CUNO EUROPE SA CUNO EUROPE SA II 2/26/1997 CUNO EUROPE SA STATUS Type SUBMIT DATE I 2/26/1997 HOLDER CUNO EUROPE SA SUBJECT

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN MAZERES SUR SALA, FRANCE ZETACARBON R.4 SP AND SLP SERIES, MANUFACTURED IN MAZERES SUR SALAT, FRANCE ZETA-PLUS CP SERIES, MANUFACTURED IN MAZERES SUR SALAT, FRANCE ZETA-PLUS DELIPID DEL 1 AND DEL 1 LP SERIES, MANUFACTURED IN MAZERES SUR SALA, FRANCE ZETA-PLUS HTP AND HTM SERIES, MANUFACTURED IN MAZERES SUR SALAT, FRANCE LOVASTATIN, MANUFACTURED IN ZHEJIANG, CHINA CLOZAPINE, MANUFACTURED BY SICOR SA IN LIMAY, FRANCE MANUFACTURED SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN MAHARASHTRA, INDIA URIDINE 5'-TRIPHOSPHATE, TRISODIUM SALT (UTP, 3NA), MANUFACTURED IN CHIBAKEN, JAPAN TRAMADOL HYDROCHLORIDE, MANUFACTURED IN HLOHOVEC, SLOVAKIA AD-32 BULK DRUG SUBSTANCE, MANUFACTURED IN MILAN, ITALY AQUACOAT CPD CELLULOSE ACETATE PHTHALATE AQUEOUS DISPERSION, MANUFACTURED IN NEWARK, DELAWARE IGI 1239, MANUFACTURED IN AGINCOURT, ONTARIO, CANADA 100488 AB POLYETHYLENE MASTERBACH, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA AND MESSANCY, BELGIUM 10437 SLIP POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA AND MESSANCY, BELGIUM STERILE MFG IN FACILITIES FOR THE PRODUCTION OF OPHTHALMIC AND CONTACT LENS SOLUTIONS PEPTIDE P280, MANUFACTURED IN TORRANCE, CALIFARNIA BUPRENORPHINE HCI, MANUFACTURED IN DANSOM LANE, UK PHENOLIC SPRAY COATING AS MFG IN BIRMINGHAM, ALABAMA PHENOLIC SPRAY COATING AS MFG IN WAUKEGAN, ILLINOIS NOVOLEN 3248 TC, MANUFACTURED IN TARAGONA, SPAIN LOVIRIDE DRUG SUBSTANCE, MANUFACTURED IN BEERSE AND GEEL, BELGIUM AND CALAIS CEDEX, FRANCE CALCITRIOL, MANUFACTURED IN PETAH TIQVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD NADIFLOXACIN DRUG SUBSTANCE, MANUFACTURED IN TOKUSHIMA, JAPAN SULFAMYLON (MAFENIDE) ACETATE, MANUFACTURED IN RENSSELAER, N.Y. KW-2189 DRUG SUBSTANCE, MANUFACTURED IN TOKYO, JAPAN TESSALON DRUG SUBSTANCE, (BENZONATATE, USP), (ESUB) MANUFACTURED IN GRIMSBY, ENGLAND

7-AMINOCEPHALOSPORANIC ACID, (7-ACA), MANUFACTURED IN KYEONGKI-DO, KOREA TERAZOSIN HCI. 2H20 BULK SUBSTANCE, MANUFACTURED IN FRESONARA (AL)-ITALY

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4Q2012EXCEL DMF# 12425 12426 12427 I 12428 12429 12430 12431 12432 12433 12434 12435 12436 12437 12438 I 12439 12440 A 12441 A 12442 I 12443 12444 12445 12446 12447 I 12448 I 12449 I 12450 12451 12452 12453 12454 I 12455 12456 I 12457 I III 3/13/1997 BASF AKTIENGESELLSCHAFT A II III 4/7/1997 4/2/1997 GUFIC BIOSCIENCES LTD AMPACET CORP A A A I III III III III I 4/1/1997 4/1/1997 4/1/1997 4/4/1997 4/2/1997 CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS SAFTA SPA SCHENK FILTERBAU GMBH SV-54258, MANUFACTURED IN KALKASKA, MI SV-14258NT, MANUFACTURED IN KALKASKA, MI SV-14157NNT, MANUFACTURED IN KALKASKA, MI STERIFOIL 121235, MANUFACTURED IN PIACENZA, ITALY II 4/3/1997 PHARM ECO LABORATORIES INC III 4/2/1997 AMPACET CORP I A I I II II II III I 3/28/1997 3/26/1997 3/18/1997 3/21/1997 3/24/1997 II 3/31/1997 ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV SCHERING PLOUGH PRODUCTS INC FERMION OY NAPP TECHNOLOGIES INC CREST FLEXIBLE PACKAGING LTD BEA FILTRI SPA II 3/31/1997 MALLINCKRODT INC I II II 3/6/1997 3/24/1997 I I I A A A A A A I III III III III III III III III III II II 2/11/1997 3/27/1997 3/27/1997 3/12/1997 3/12/1997 3/12/1997 3/12/1997 3/12/1997 3/12/1997 3/26/1997 3/12/1997 ASPELL POLYMERES DSM PERFORMANCE POLYMERS DSM POLYETHYLENES ALBIS PLASTIC GMBH ALBIS PLASTIC GMBH ALBIS PLASTIC GMBH ALBIS PLASTIC GMBH ALBIS PLASTIC GMBH ALBIS PLASTIC GMBH SIEGFRIED LTD PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA SANOFI AVENTIS CHIMIE SANDOZ INDUSTRIAL PRODUCTS GMBH STATUS Type SUBMIT DATE I I II II I 3/20/1997 3/19/1997 3/19/1997 HOLDER PROMETIC BIOSCIENCES LTD YAMANOUCHI IRELAND CO LTD YMC CO LTD SUBJECT MIMETIC ORANGE 1-6XL, MANUFACTURED IN ISLE OF MAN, GREAT BRITAIN FORMOTEROL FUMERATE, MANUFACTURED IN DUBLIN, IRELAND

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN ISHIKAWA, JAPAN LACQTENE 2003 SN 53 U, MANUFACTURED IN GONFREVILLE L'ORCHER, HARFLEUR STAMYLAN P 17M10, MANUFACTURED IN GELEEN, THE NETHERLANDS STAMYLAN HD 7625, MANUFACTURED IN BEEK, THE NETHERLANDS LUPOLEN 1810 S WHITE 99950, MANUFACTURED IN HAMBURG, GERMANY LUPOLEN 1810 E WHITE 99950, MANUFACTURED IN HAMBURG, GERMANY LUPOLEN 3020 D WHITE 99950, MANUFACTURED IN HAMBURG, GERMANY LUPOLEN 5021 D WHITE 99950, MANUFACTURED IN HAMBURG, GERMANY LUPOLEN 5031 L WHITE 99950, MANUFACTURED IN HAMBURG, GERMANY LUPOLEN KONZENTRAT SL 02 OA, MANUFACTURED IN HAMBURG, GERMANY FLUOXETINE HYDROCHLORIDE, MANUFACTURED IN ZOFINGEN, SWITZERLAND BACLOFEN, MANUFACTURED IN VARESE, ITALY CLOPIDOGREL BISULFATE, MANUFACTURED IN SISTERON, FRANCE 7-AMINOCEPHALOSPORANIC ACID, ENZYMATIC, MANUFACTURED IN FRANKFURT, GERMANY DIPHENOXYLATE HYDROCHLORIDE USP, (ESUB) MANUFACTURED IN ST. LOUIS, MISSOURI IOPAMIDOL, USP, MANUFACTURED IN NORTH CHICAGO, IL STERILE WATER FOR INJECTION, MANUFACTURED IN MANATI, PUERTO RICO ENTACAPONE, MANUFACTURED IN HANKO AND ESPOO, FINLAND NABUMETONE, MANUFACTURED IN COVENTRY, RHODE ISLAND PAPER/PE/FOIL/PE, MANUFACTURED IN KENT, ENGLAND MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN MILANO, ITALY 100652 ANTIBLOCK SLIP POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA AND MESSANCY, BELGIUM 2-AMINO-5-PHENYL-4(5H)-OXAZOLONE-(PEMOLINE), MANUFACURED IN LEXINGTON, MA

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN WALDSTETTEN, GERMANY MICONAZOLE NITRATE USP, MANUFACTURED IN GUJARAT STATE, INDIA 109982 ANTIBLOCK POLYETHYENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA AND MESSANCY, BELGIUM NOVOLEN 110 H Q651, MANUFACTURED IN WESSELING, GERMANY

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4Q2012EXCEL DMF# 12458 A 12459 12460 12461 I 12462 I 12463 I 12464 A 12465 A 12466 12467 12468 12469 12470 12471 12472 12473 I 12474 12475 A 12476 12477 12478 12479 I 12480 12481 12482 12483 12484 I 12485 A 12486 12487 12488 12489 12490 A I I I I V III III II II 4/24/1997 2/24/1997 2/24/1997 4/30/1997 3/27/1997 II 4/8/1997 I I I I II II IV IV I 3/4/1997 4/25/1997 4/10/1997 4/24/1997 4/21/1997 POLFA TARCHOMIN STANDARD CHEM AND PHARM CO LTD CERESTAR USA INC LA DREYFUS CO SCHERING GMBH UND CO PRODUKTIONS KG DYNAMIT NOBEL GMBH EXPLOSIVSTOFF UND SYSTEMECHNIK STERIGENICS INTERNATIONAL ALVEO AG ALVEO AG REHEIS INC HARBIN PHARMACEUTICAL FACTORY I I A II II III III 4/18/1997 4/22/1997 4/18/1997 4/15/1997 PROQUINA SA CARA PARTNERS WALLINGSTOWN LTD SCHOTT FRANCE PHARMA SYSTEM SAS POLYMER COLOR INC I IV II 4/10/1997 4/17/1997 ADHESIVES RESEARCH INC RANKE QUIMICA SL A I I A A A I III II III II III II II I 4/11/1997 4/15/1997 3/25/1997 4/14/1997 4/11/1997 4/14/1997 4/11/1997 4/14/1997 LUBRIZOL ADVANCED MATERIALS INC DOCTOR REDDYS LABORATORIES LTD DRYCOLOR AB UNIQUE CHEMICALS CLARIANT MASTERBATCHES NORDEN AB ESTEVE QUIMICA SA EXCELLA GMBH DOCTORS ORGANIC CHEMICALS LTD III 4/17/1997 WIPF AG III 4/10/1997 3M DRUG DELIVERY SYSTEMS II 4/9/1997 ADVANCED CHEMTECH INC II 3/6/1997 SAMYANG GENEX RESEARCH CORP A I III II II 4/4/1997 4/8/1997 4/9/1997 FUJIMORI KOGYO CO LTD SANOFI SYNTHELABO INC. DAIICHI PHARMACEUTICAL CO LTD STATUS Type SUBMIT DATE III 4/8/1997 HOLDER LOPAREX BV SUBJECT

4Q2012

FL2000 175UM HDPE EASY/EASY (PRODUCT CODE 78D171), MANUFACTURED IN APELDORN, THE NETHERLANDS PLASTIC FILM AND BAG, MANUFACTURED IN MIE PREFECTURE, JAPAN CLOPIDOGREL BISULFATE, MANUFACTURED IN EVIONNAZ, SWITZERLAND DX-8951F DRUG SUBSTANCE, MANUFACTURED BY CHEMSYN SCIENCE LABORATORIES IN LENEXA, KANSAS BULK PHARMACEUTICAL CHEMICAL GENEXOL, PLANT A, MANUFACTURED IN TAEJEON, KOREA GONADERELIN ACETATE BULK PHARMACEUTICAL CHEMICAL, MANUFACTURED IN LOUISVILLE, KY PACKAGING MATERIAL FOR THE CICLESONIDE HFA METERED DOSE INHALER MANUFACTURED IN ST. PAUL, MN POLYESTER-ALUMINIUM-POLYACRYLONITRILE LAMINATE, MANUFACTURED IN VOLKETSWIL, SWITZERLAND STAT-RITE E-1150, MANUFACTURED IN CLEVELAND, OHIO DEXTROMETHORPHAN HYDROBROMIDE, MANUFACTURED IN SRIKAKOLAM DISTRICT MASTERBACH PE 192301, MANUFACTURED IN MALMO, SWEDEN DICLOFENAC SODIUM, MANUFACTURED IN GUJARAT, INDIA MASTERBATCH PE 192183, MANUFACTURED IN MALMO, SWEEDEN QUINAPRIL HCL, MANUFACTURED IN BARCELONA, SPAIN METHOTREXATE DISODIUM SALT, MANUFACTURED IN FEUCHT, GERMANY MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN K. ILLINDALAPARRU, TANUKU, ANDHRA PRADESH, INDIA MEDICAL GRADE ADHESIVES, MANUFACTURED IN GLEN ROCK, PENNSYLVANIA ALMOTRIPTAN, LAS 31416 D,L HYDROGEN MALATE, MANUFACTURED IN BARCELONA, SPAIN ESTRIOL, MANUFACTURED IN IXTACZOQUITLAN, VER., MEXICO GINKGO BILOBA EXTRACT, MANUFACTURED IN IN CO. CORK, IRELAND GLASS AMPOULES, MANUFACTURED IN PONT-SUR-YONNE, FRANCE BLC-19380 25/1 PROCESS BLUE COLOR CONCENTRATE, MANUFACTURED IN MCHENRY, ILLINOIS 7-ADC ACID, MANUFACTURED IN WARSAW, POLAND LOVASTATIN, MANUFACTURED IN TAIWAN, R.O.C. HYDROXYPROPYL BETA CYCLODEXTRIN, MANUFACTURED IN WAUKEGAN, IL DREYCO CHEWING GUM BASE, MANUFACTURED IN EDISON, NEW JERSEY MANUFACTURING SITE, FACILITIES, PERSONNEL AND PROCEDURES IN WEIMAR, GERMANY GLYCEROLTRINITRATE-DUROTAK 387-2516 SOLUTION, MANUFACTURED IN LEVERKUSEN, GERMANY CONTRACT STERILIZATION FACILITY IN HAYWARD, CA ALVEOLIT TEE 3000 WHITE, MANUFACTURED IN LUZERN, SWITZERLAND ALVEOLIT TEE 1000 WHITE, MANUFACTURED IN LUZERN, SWITZERLAND ALUMINUM NITRATO HYDRATE, MANUFACTURED IN BERKELEY HEIGHTS, NJ PENICILLIN G POTASSIUM CRUDE, MANUFACTURED IN HARBIN, CHINA

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4Q2012EXCEL DMF# 12491 I 12492 12493 12494 12495 12496 I 12497 12498 I 12499 12500 12501 12502 I 12503 12504 I 12505 12506 12507 12508 12509 12510 12511 12512 12513 12514 12515 12516 A 12517 I 12518 I 12519 I 12520 12521 12522 12523 A I A A III III II II 4/10/1997 3/25/1997 5/12/1997 5/23/1997 DRYCOLOR AB CLARIANT MASTERBATCHES NORDEN AB NEOMPS INC MASTERBACH PE 142365, MANUFACTURED IN MALMO, SWEDON MASTERBATCH PE 192300, MANUFACTURED IN MALMO, SWEDEN ACYLINE, MANUFACTURED IN SAN DIEGO, CA IV 5/5/1997 V 5/20/1997 I 5/23/1997 POLYPEPTIDE LABORATORIES AS I A I I A I I I I A I II III III V II III II II II IV II III 5/15/1997 4/24/1997 5/5/1997 5/16/1997 5/15/1997 5/15/1997 5/19/1997 5/21/1997 5/23/1997 4/25/1997 5/23/1997 5/20/1997 EGIS PHARMACEUTICALS PUBLIC LTD CO A SCHULMAN INC BASF AKTIENGESELLSCHAFT RENTSCHLER BIOTECHNOLOGIE GMBH LUSOCHIMICA SPA ROLLPRINT PACKAGING PRODUCTS INC ERREGIERRE SPA MAX INDIA LTD CYCLACEL LTD CHP CARBOHYDRATE PIRNA GMBH CO KG ALDRICH CHEMICAL CO INC BASF CORP A II III 5/13/1997 5/8/1997 NEULAND LABORATORIES LTD AMPACET CORP A I I III IV II I 4/28/1997 5/8/1997 5/8/1997 5/8/1997 PLASTIAPE SPA HENKEL CORP VERA LABS LTD VERA LABS LTD A III I 5/5/1997 4/28/1997 I A I I II III IV III II 4/21/1997 3/27/1997 4/30/1997 4/30/1997 5/8/1997 THATCHER CO LANXESS CORP ROUGIER INC BECTON DICKINSON AND CO CHONGQING DAXIN PHARMACEUTICAL CO LTD BD MEDICAL PHARMACEUTICAL SYSTEMS PLASTIAPE SPA STATUS Type SUBMIT DATE II 4/28/1997 HOLDER NANOSYSTEMS SUBJECT

4Q2012

RAPAMYCIN NANOCRYSTAL COLLOIDAL DISPERSION-JAR MILLING PROCESS, MANUFACTURED IN HORSHAM, PA CHLORHEXIDINE GLUCONATE, 20% (W/V), MANUFACTURED IN SALT LAKE CITY, UTAH PERBUNAN, MANUFACTURED IN LEVERKUSEN, GERMANY CONTRAMID, MANUFACTURED IN QUEBEC, CANADA BD AUTO-INJECTOR CARTRIDGE, MANUFACTURED IN LE PONT-DE-CLAIX, FRANCE LOVASTATIN, USP, MANUFACTURED IN SICHUAN, CHINA BD READYFILL, MANUFACTURED IN LE PONT-DE-CLAIX, FRANCE MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN OSNAGO, ITLAY AEROLISER INHALATION DEVICE, MANUFACTURED IN OSNAGO, ITALY GLUCOPON 625 UP, MANUFACTURED IN CINCINNATI, OHIO RANITIDINE BULK DRUG, MANUFACTURED IN ANDHRA PRADESH, INDIA MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN ANDHRA PRADESH, INDIA RANITIDINE, MANUFACTURED IN ANDHRA PRADESH, INDIA 10562 PROCESS AID POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN DERIDDER, LA CARTERSVILLE, GA AND MESSANCY, BELGIUM LEVODOPA USP BULK, MANUFACTURED IN BUDAPEST, HUNGARY POLYETHYLENE PACKAGING COMPONENTS, MANUFACTURED IN AKRON OHIO NOVOLEN 1100 H, MANUFACTURED IN TARAGONA, SPAIN STERILE PROCESSING FACILITY LOCATED IN LAUPHEIM, GERMANY CARTEOLOL HYDROCHLORIDE, MANUFACTURED IN LOMAGNA, ITALY RPP #26-3027, MANUFACTURED IN ADDISON, ILLINOIS ISOXSUPRINE HYDROCHLORIDE USP, MANUFACTURED IN BERGAMO, ITALY CARBAMAZEPINE BULK DRUG SUBSTANCE, MANUFACTURED IN KARNATAKA, INDIA CS-682, MANUFACTURED IN KANAGAWA, JAPAN SODIUM STARCH GLYCOLATE USP/NF, MANUFACTURED IN PIRNA, GERMANY SQUALENE, MANUFACTURED IN SHEBOYGAN FALLS, WI LUTONAL A 50, 50% IN ETHYL ALCOHOL MANUFACTURED IN LUDWIGSHAFEN, GERMANY

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN HILLEROD, DENMARK NATIONAL INSTITUTES HEALTH NATIONAL PLASMA HIV-RNA IN CLINICAL TRIALS SUPPORTING TRADITIONAL APPROVAL OF AN INSTITUTE ALLERGY INFECTIOUS DISEASES ANTIRETROVIRAL DRUG:DATA ANALYSIS ISSUES MARUTI INDUSTRIAL CARBOHYDRATES LTD SODIUM STARCH GLYCOLATE, MANUFACTURED IN TAMILNADU, INDIA

JIANGXI DONGFENG PHARMACEUTICAL LLC PENICILLIN G POTASSIUM USP23, MANUFACTURED IN LEPING, JIANGXI, CHINA

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4Q2012EXCEL DMF# 12524 12525 12526 I 12527 12528 I 12529 I 12530 12531 I 12532 12533 12534 12535 12536 12537 12538 12539 12540 12541 12542 12543 12544 12545 I 12546 A 12547 I 12548 12549 12550 I 12551 I 12552 12553 12554 12555 A 12556 I V 5/6/1997 IVEX PHARMACEUTICALS A A A II II II II 6/19/1997 6/18/1997 6/18/1997 6/23/1997 II 6/17/1997 FAULDING PHARMACEUTICALS SUB FH FAULDING AND CO LTD WOCKHARDT LTD CHEMAGIS LTD TAIHO PHARMACEUTICAL CO LTD CORDEN PHARMA SWITZERLAND LLC A A III IV II 6/18/1997 6/7/1997 6/17/1997 MYLAN TECHNOLOGIES INC JRS PHARMA LP GENZYME PHARMACEUTICALS III 6/12/1997 3M DRUG DELIVERY SYSTEMS II 6/3/1997 A I I I I I I I I A I A I II III III III III III III III II II II II II II 6/2/1997 5/20/1997 5/20/1997 5/20/1997 5/20/1997 5/20/1997 5/20/1997 5/20/1997 6/9/1997 4/17/1997 6/5/1997 6/11/1997 6/10/1997 5/23/1997 NEULAND LABORATORIES LTD PECHINEY SOPLARIL FLEXIBLE EUROPE PECHINEY SOPLARIL FLEXIBLE EUROPE PECHINEY SOPLARIL FLEXIBLE EUROPE PECHINEY SOPLARIL FLEXIBLE EUROPE PECHINEY SOPLARIL FLEXIBLE EUROPE PECHINEY SOPLARIL FLEXIBLE EUROPE PECHINEY SOPLARIL FLEXIBLE EUROPE STAR TOBACCO PHARMACEUTICALS INC FINE CHEMICALS CORP PTY LTD JANSSEN PHARMACEUTICA NV SHASUN PHARMACEUTICALS LTD XECHEM INC PROTEIN TECHNOLOGIES INTERNATIONAL INC FINORGA A II V 5/28/1997 6/3/1997 TEVA PHARMACEUTICAL INDUSTRIES LTD BRISTOL MYERS SQUIBB CARIBBEAN CO II 5/30/1997 HOECHST MARION ROUSSEL SA I III II 5/26/1997 5/30/1997 STATUS Type SUBMIT DATE A A IV III II 6/2/1997 5/5/1997 5/23/1997 HOLDER SEPPIC SA APTAR FRANCE SAS PROTEIN TECHNOLOGIES INTERNATIONAL INC AMPHABEL SA HOECHST MARION ROUSSEL SA SUBJECT SEPIFILM LP-WHITE RANGE(761 AND 770)

4Q2012

APTAR VP3 PUMPS, MANUFACTURED IN LE VAUDREUIL, FRANCE AND CONGERS, NY PTI G-4660, MANUFACTURED IN ST. LOUIS, MO GLASS VAILS, MANUFACTURED IN LESSINES, BELGIUM DOBUTAMINE ISONICOTINATE/ OFF-0358-A-01-1, MANUFACTURED IN VERTOLAYE, FRANCE DOBUTAMINE HYDROCHLORIDE/STE 443-A-01-1, MANUFACTURED IN NEUVILLE SUR SAONE, FRANCE HALOPERIDOL DECANOATE, MANUFACTURED IN VARESE, ITALY PARENTERAL MANUFACTURING FACILITY DESCRIPTION AND PROCESSVALIDATION SUMMARY AS PERFORMED IN MAYAGUEZ, PUERTO RICO RANITIDINE HYDROCHLORIDE (FORM I), MANUFACTURED IN ANDHRA PRADESH, INDIA LID 20 UM HARD FOIL, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE LID 20 UM ANNEALED FOIL, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE LID 25 UM ANNEALED FOIL, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE LID 25 UM HARD FOIL, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE LID 30 UM ANNEALED FOIL, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE LID 30 UM HARD FOIL, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE LID 15 UM HARD FOIL, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE TOBACCO GOLD, MANUFACTURED IN KEYSVILLE, VIRGINIA (R)-(-)-BACLOFEN, MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA LUBELUZOLE, MANUFACTURED IN BEERSE AND GEEL, BELGIUM RANITIDINE, MANUFACTURED IN CUDDALORE, INDIA PACLITAXEL BULK DRUG SUBSTANCE, MANUFACTURED IN NEW BRUNSWICK, NJ PTI G-2535 (UNCONJUGATED ISOFLAVONES-70), MANUFACTURED BY SIGMA CHEMICLAL COMPANY IN ST. LOUIS, MO ALFUZOSIN HYDROCHLORIDE (INN), SL77-0499-10, MANUFACTURED IN CHASSE SUR RHONE, FRANCE A66000 25UL SPRAYMISER VALVE, MANUFACTURED IN GLOUCESTERSHIRE, GREAT BRITAIN MEDIDERM 3500, MANUFACTURED IN ST. ALBANS, VT LUBRITAB, MANUFACTURED IN JACKSON, IL 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL, AMMONIUM SALT (POPG, NH4) MANUFACTURED IN LIETAL, SWITZERLAND COATED CIMETIDINE POWDER, MANUFACTURED IN SALISBURY SOUTH, SOUTH AUSTRALIA RANITIDINE HYDROCHLORIDE, MANUFACTURED IN GUJARAT STATE, INDIA MIDAZOLAM, MANUFACTURED IN BEER SHEVA, ISRAEL CDHP, MANUFACTURED IN SAITAMA, JAPAN 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DPPC), MANUFACTURED IN LIESTAL, SWITZERLAND MANUFACTURING SITE, FACILITIES AND PERSONNEL IN COUNTY ANTRIM, NORTHERN IRELAND Page 365

4Q2012EXCEL DMF# 12557 12558 12559 12560 12561 12562 12563 12564 12565 A 12566 12567 I 12568 I 12569 12570 I II III 7/2/1997 6/19/1997 CASCADE BIOCHEMICAL LTD CARCANO ANTONIO S.P.A. II 6/30/1997 SUMIKA FINE CHEMICALS CO LTD I III IV 6/18/1997 6/23/1997 SOLVAY DRAKA INC. INTERNATIONAL SPECIALTY PRODUCTS STATUS Type SUBMIT DATE I A I I I A I I II II II III III II I II III 6/19/1997 6/17/1997 6/25/1997 5/23/1997 6/27/1997 6/26/1997 7/2/1997 6/25/1997 6/25/1997 HOLDER SHAOXING PHARMACEUTICAL FACTORY FARMAK AS VERA LABORATORIES LTD GEORGIA PACKAGING INC ISHIDA PRESS KOGYO CO LTD TEVA PHARMACEUTICAL INDUSTRIES LTD SEPRACOR CANADA LTD SELOC AG STYROLUTION GMBH SUBJECT NYSTATIN, MANUFACTURED IN ZHEJIANG, CHINA

4Q2012

KETOROLAC TROMETHAMINE, MANUFACTURED IN OLOMOUC, CZECH REPUBLIC NAPROXEN SODIUM, MANUFACTURED IN ANDHRA PRADESH, INDIA PRODUCT 41722-35, MANUFACTURED IN COLUMBUS, GA ALUMINUM CAPS FOR MEDICAL VIALS, MANUFACTURED IN SAITAMA, JAPAN PENTOXIFYLLINE, MANUFACTURED IN NETANYA, ISRAEL MANUFACTURING SITE, FACILITIES, AND PERSONNEL IN NONA SCOTIA, CANADA ISOSORBIDE CONCENTRATE, MANUFACTURED BY SIFA LTD. IN CO. CLARE, IRELAND POLYSTYROL 143 E, MANUFACTURED IN LUDWIGSHAFEN, GERMANY AND ANTWERPEN, BELGIUM SOLMED 91 FILM, MANUFACTURED IN LAPORTE, INDIANA CELEX 101, MICROCRYSTALLINE CELLULOSE, NF, MANUFACTURED BY ISP-CHEMFEILDS IN DIST. NAGPUR, INDIA OXONIC ACID POTASSIUM SALT, MANUFACTURED A OSAKA PLANT IN OSAKA CITY, JAPAN ALPROSTADIL, MANUFACTURED IN BERKSHIRE, UNITED KINGDOM ALUMINIUM FOIL, SMOOTH, SOFT TEMPER, 0.040MM, LACQUERED FOR PRINTING OR WITH TEXT IN BLACK COLOUR ON ONE SIDE AND LAMINATED ADHESIVE TO POLYETHYLENE FILM 0.025MM ON THE OTHER SIDE, MANUFACTURED IN MANDELLO DEL LARIO-LC-ITALY RAPAMYCIN NANOCRYSTAL COLLOIDAL DISPERSION-MEDIA MILLING PROCESS, MANUFACTURED IN HORSHAM, PA RPP #26-3028, MANUFACTURED IN ADDISON, ILLINOIS AND BLOOMFIELD, CT STEDIM 5 BAGS, MANUFACTURED IN AUBAGNE CEDEX, FRANCE LID 30 UM HARD FOIL WITHOUT PHTALATES, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE LID 15 UM HARD FOIL WITHOUT PHTALATES, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE LID 20 UM HARD FOIL WITHOUT PHTALATES, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE LID 20 UM HARD FOIL WITHOUT PHTALATES, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE LID 20 UM ANNEALED FOIL WITHOUT PHTALATES, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE LID 25 UM ANNEALED FOIL WITHOUT PHTALATES, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE LID 30 UM ANNEALED FOIL WITHOUT PHTALATES, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE TERAZOSIN HCL-FORM 1, MANUFACTURED IN VARESE, ITALY PINEAPPLE FLAVOR 9/H04395, CHOCOLATE FLAVOR SPRAY DRIED 9/H07215, STRAWBERRY FLAVOR ARTIFICIAL TYPE 9/H04832, AND VANILLA FLAVOR 9/H00625, MANUFACTURED IN PANDON LOOP, SINGAPORE ALORA ESTRADIOL TRANSDERMAL SYSTEM, MANUFACTURED IN SALT LAKE CITY, UTAH

I 12571 A 12572 12573 12574 I 12575 I 12576 I 12577 I 12578 I 12579 I 12580 I 12581 I 12582 I 12583 I II 6/17/1997 THERATECH INC IV 7/7/1997 II 7/8/1997 PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA SYMRISE INC III 6/25/1997 PECHINEY SOPLARIL FLEXIBLE EUROPE III 6/25/1997 PECHINEY EMBALLAGE ALIMENTAIRE III 6/25/1997 PECHINEY SOPLARIL FLEXIBLE EUROPE III 6/25/1997 PECHINEY SOPLARIL FLEXIBLE EUROPE III 6/25/1997 PECHINEY SOPLARIL FLEXIBLE EUROPE III 6/25/1997 PECHINEY SOPLARIL FLEXIBLE EUROPE I I III III III 6/12/1997 7/8/1997 6/25/1997 ROLLPRINT PACKAGING PRODUCTS INC STEDIM SA PECHINEY SOPLARIL FLEXIBLE EUROPE II 7/9/1997 ALKERMES GAINESVILLE LLC

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4Q2012EXCEL DMF# 12584 A 12585 12586 12587 12588 A 12589 12590 I 12591 I 12592 A 12593 I 12594 12595 12596 12597 I 12598 I 12599 12600 12601 I 12602 A 12603 12604 I 12605 12606 A 12607 12608 I 12609 I 12610 I 12611 I 12612 A II 8/5/1997 FERRO PFANSTIEHL INC AMMONIUM LACTATE MANUFACTURED IN WAUKEGAN, IL. IV 6/18/1997 III 7/30/1997 I 7/24/1997 A II III 7/25/1997 7/28/1997 TEVA PHARMACEUTICAL INDUSTRIES LTD ERACO AS A II III 7/23/1997 7/21/1997 QUIMICA SINTETICA SA SUD CHEMIE PERFORMANCE PACKAGING A III II 7/24/1997 7/24/1997 BRASKEM AMERICA INC NANOSYSTEMS III 7/9/1997 LINHARDT GMBH AND CO KG I A II II III 7/18/1997 7/17/1997 7/9/1997 LONZO LTD BASF SE DUDEK PLAST AS I 7/23/1997 NORDEN PACK INTERNATIONAL AB I I A II II II III 7/18/1997 7/18/1997 7/18/1997 7/11/1997 TORRENT GUJARAT BIOTECH LTD. TORRENT GUJARAT BIOTECH LTD. CARBOGEN AMCIS AG SKILLPACK PET TECHNOLOGIES BV 6-AMINO PENICILLANIC ACID, MANUFACTURED IN VADODARA, INDIA PENICILLANIC G POTASSIUM, MANUFACTURED IN VADODARA, INDIA TROPICAMIDE, MANUFACTURED IN BUDENDORF, SWITZERLAND III 7/15/1997 HELVOET PHARMA MARYLAND III 7/22/1997 V 7/11/1997 NATIONAL INSTITUTES HEALTH NATIONAL CANCER INSTITUTE LAMP S PROSPERO SPA I II IV 7/11/1997 7/8/1997 FERMION OY MITSUBISHI CHEMICAL CORP A A I II II III III 7/9/1997 7/9/1997 7/7/1997 7/7/1997 ACS DOBFAR SPA ACS DOBFAR SPA GRAND POLYMER CO LTD ST GOBAIN DESJONQUERES SA SGD STATUS Type SUBMIT DATE II 7/11/1997 HOLDER NICOBRAND LTD SUBJECT

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NICOTINE BITARTRATE DIHYDRATE, MANUFACURED IN CO. LONDONDERRY, NORTHERN IRELAND SODIUM BICARBONATE, STERILE, MANUFACTURED IN MILANO, ITALY CEPHALOTHIN SODIUM, ORAL GRADE, MANUFACTURED IN MILANO, ITALY GRANDPOLYPRO J216, MANUFACTURED IN CHIBA, JAPAN SILICONIZATION PROCEDURE FOR GLASS PACKAGING MATERIAL IN MERS LES BAINS, FRANCE AZATHIOPRINE, MANUFACTURED IN OULU, FINLAND SUCROSE STEARIC ACID ESTERS AND SUCROSE PALMITIC ACID ESTERS, MANUFACTURED IN MIE PREFECTURE, JAPAN PRECLINICAL PHARMACOLOGY AND TOXICOLOGY AGENT ISIS 5320 (NSC 665353), IN BETHESDA, MARYLAND PVC FOIL DRUG PACKAGING MATERIAL LAMINATED TO PE FILM, MANUFACTURED IN MODENA (ITALY) RUBBER CLOSURE FORMULATION B5310-45 N GRAY, MANUFACTURED IN SALISBURY, MD

POLYETHYLENE TEREPHTHALATE PACKAGING MATERIALS MANUFACTURED IN ETTENLEUR, NETHERLANDS MANUFACTURING SITE, FACILITIES, PERSONNEL, AND OPERATING PROCEDURES IN HELSINGBORG AND ASTORP, SWEDEN IMEOL, MANUFACTURED IN VISP, SWITZERLAND UVINUL N 539 T, MANUFACTURED IN LUDWIGSHAFEN, GERMANY TABLET CONTAINER AND CAPS IN FIVE SIZES 150ML, 250ML, 300ML, 400ML AND 500ML, MANUFACTURED IN JONSTRUP, DENMARK ALUMINIUM TUBES FOR THE COSMETIC, THE PHARMACEUTICAL AND THE FOOD SECTOR, MANUFACTURED IN VIECHTACH, HAMBRUCKEN, AND PAUSA, GERMANY POLYPROPYLENE 5E88S, MANUFACTURED IN NORCO, LA AND NORTH SEADRIFT, TX L-754,030 NANOCRYSTAL COLLOIDAL DISPERSION-JAR MILLING PROCESS, MANFACTURED IN HORSHAM, PA OMEPRAZOLE, MANUFACTURED IN MADRID, SPAIN AIRSEC DRI-PAX POLY TUBES, DESICCANT PLUGS, AND DESICCANT STOPPERS, MANUFACTURED IN BELEN, NEW MEXICO DIFLORASONE DIACETATE BULK DRUG, MANUFACTURED IN MILAN, ITALY

CHILD RESISTANCE AND TAMPER EVIDENCE CLOSURES, MANUFACTURED IN FREDERIKSSUND, DENMARK NEMO SA MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN BARCELONA, SPAIN 3M DRUG DELIVERY SYSTEMS METERED DOSE AEROSOL VALVE, MANUFACTURED IN LEICESTERSHIRE, GREAT BRITAIN SHANGHAI GUANG DE LI CAPSULES CO LTD GELATIN CAPSULES MANUFACTURED IN SHANGHAI CHINA

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4Q2012EXCEL DMF# 12613 12614 I 12615 12616 12617 12618 12619 I 12620 12621 I 12622 I 12623 I 12624 A 12625 I 12626 I 12627 A 12628 I 12629 I 12630 12631 12632 12633 12634 12635 12636 12637 12638 I 12639 I 12640 A 12641 I IV 8/21/1997 PAPIERFABRIK DIV SCHOELLER AND HOESCH GMBH GEFOLUX BOPP/ML, MANUFACTURED IN GERNSBACH, GERMANY. IV 9/3/1997 ACG ASSOCIATED CAPSULES PRIVATE LTD EMPTY GELATIN CAPSULES, MANUFACTURED IN MUMBAI, INDIA II 9/2/1997 I I I I A I I A II II II III II II II II II 8/25/1997 8/27/1997 8/27/1997 8/26/1997 8/27/1997 8/29/1997 8/29/1997 8/28/1997 8/29/1997 II 8/15/1997 VEGEFLORA EXTRACOES DO NORDESTE LTDA HUBEI PHARMACEUTICAL FACTORY UNION QUIMICO FARMACEUTICA SA HAMNMI FINE CHEMICAL CO LTD STEDIM SA EXCELLA GMBH ABBOTT LABORATORIES SUMITOMO CHEMICAL CO LTD FLUOROMED LP ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV NATURAL BIOLOGICS I 8/22/1997 PHARMA BIOTECH IV 8/21/1997 FMC CORP FMC BIOPOLYMER DIV II 8/21/1997 HANA BIOSCIENCES, INC III 8/14/1997 AMPACET CORP III 3/27/1997 II 8/14/1997 PHARMACEUTICAL FINE CHEMICALS,BAHAMAS COPE ALLMAN JAYCARE LTD II 8/14/1997 FINORGA SA A II II 8/11/1997 8/12/1997 BACHEM AMERICAS INC MALLINCKRODT CHEMICAL INC I I I I II II IV II I 7/29/1997 6/9/1997 8/6/1997 8/8/1997 8/5/1997 ESTEVE QUIMICA SA GEDEON RICHTER LTD EASTMAN DENTAL CENTER RANBAXY PHARMACEUTICALS ORGANICHEM CORP STATUS Type SUBMIT DATE A II II 8/4/1997 8/5/1997 HOLDER ERREGIERRE SPA DIOSYNTH BV SUBJECT TIOCONAZOLE, MANUFACTURED IN BERGAMO, ITALY. DEHYDROISOANDROSTERONE SODIUM SULPHATE, MANUFACTURED IN IN TLALNEPANTLA, STATE OF MEXICO, MEXICO. VPA-985, MANUFACTURED IN CELRA (GIRONA) SPAIN GLUTETHIMIDE, MANUFACTURED IN BUDAPEST, HUNGARY SAIB SPECIAL GRADE (SG), MANUFACTURED IN KINGSPORT, TN. ETODOLAC DRUG SUBSTANCE, MANUFACTURED IN MADHYA PRADESH, INDIA

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURE IN CORK, IRELAND. VASOACTIVE INTESTINAL PEPTIDE (VIP), HUMAN, MANUFACTURED IN TORRANCE, CA. ACYCLOVIR USP (MICRONIZED), CODED 2524, MANUFACTURED BY POWDERSIZE, INC. IN QUAKERTOWN PA. 6-BENZYL-1-ETHOXYMETHYL-5-ISOPROPYLURACIL, MANUFACTURED IN CHASSE-SURRHONE, FRANCE. NABUMETONE, MANUFACTURED IN FREEPORT GRAND BAHAMAS ISLAND, BAHAMAS SECURIPAC, VITAPAC CONTAINER WITH JAYCAP CLOSURE, MANUFACTURED IN LONDON, ENGLAND 11200 WHITE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, AND CARTERSVILLE, GA VINCRISTINE SULFATE LIPOSOME INJECTION, MANUFACTURED IN VANCOUVER CANADA AVICEL CE-15 MICROCRYSTALLINE CELLULOSE AND GUAR GUM, MANUFACTURED IN NEWARK, DE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND OPERATING PROCEDURES IN SIGNES, FRANCE. PILOCARPINE USP, MANUFACTURED IN PARNAIBA-PI-BRASIL NAPROXEN USP, MANUFACTURED IN HUBEI, P.R. CHINA. FLUOXETINE HYDROCHLORIDE, USP, MANUFACTURED IN BARCELONA, SPAIN. CEFOTAXIME ACID, MANUFACTURED IN KYONGGI-DO, REPUBLIC OF KOREA. EVA BAGS MANUFACTURED IN AUBAGNE CEDEX, FRANCE. DOXAZOSIN MESYLATE (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY TROMETHAMINE,USP, MANUFACTURED IN NORTH CHICAGO, IL BMCB(INERMEDIATE) MANUFACTURED IN OKAYAMA PREFECTURE, JAPAN APF-N40M, MANUFACTURED IN ROUND ROCK, TX. BETAXOLOL HYDROCHLORIDE, USP MANUFACTURED IN NORTH CHICAGO, IL. NATURAL CONJUGATED ESTROGEN-BULK INGREDIENT, MANUFACTURED IN AUSTIN, MN

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4Q2012EXCEL DMF# 12642 I 12643 12644 I 12645 A 12646 12647 12648 12649 I 12650 12651 I 12652 12653 A 12654 12655 12656 A 12657 A 12658 12659 12660 12661 A 12662 12663 A 12664 A 12665 12666 A 12667 12668 12669 12670 A I I A II III II II 9/26/1997 9/10/1997 9/22/1997 9/30/1997 FINE ORGANICS LTD PLASTICOS ARCO IRIS SA DE CV WANBURY LTD MERCK SANTE SAS I II III 9/23/1997 9/26/1997 III 9/19/1997 GEORGIA GULF CHEMICALS AND VINYLS LLC SHASUN CHEMICALS AND DRUGS LTD INEOS CHLORVINYLS BELGIUM NV A II III 9/20/1997 9/1/1997 I A I III II III II 9/19/1997 9/18/1997 8/8/1997 9/19/1997 SABIC PETROCHEMICALS BV AMRI RENSSELAER INC DANAPAK FLEXIBLES JOHNSON MATTHEY PHARMACEUTICAL MATERIALS FARMABIOS S P A 3M DRUG DELIVERY SYSTEMS III 9/22/1997 REXAM HEALTHCARE OFFRANVILLE SAS I I III II II 8/9/1997 9/11/1997 9/10/1997 I II III 9/15/1997 8/6/1997 DSM ANDENO GMBH WEBER INTERNATIONAL PACKAGING CORPORATION ELM PLASTIC GMBH FINE CHEMICALS CORPORATION LTD SYN TECH CHEM AND PHARM CO LTD A II III 9/11/1997 8/28/1997 MOREPEN LABORATORIES LTD LOPAREX BV I A A II II III II 9/5/1997 9/8/1997 7/10/1997 9/8/1997 MALLINCKRODT CHEMICAL INC USV LIMITED APTAR FRANCE SAS CILAG AG PRAMLINTIDE STD AMYLIN, MANUFACTURED IN ST, LOUIS MO. METFORMIN HCL BP, MANUFACTURED IN MAHARASHTRA, INDIA. VP3 PUMPS, MANUFACTURED IN CONGERS, NY II 9/8/1997 SUMITOMO SEIKA CHEMICALS CO LTD A II I 9/4/1997 9/8/1997 STATUS Type SUBMIT DATE V 8/18/1997 HOLDER NATIONAL INSTITUTES HEALTH NATIONAL CANCER INSTITUTE DIV CANCER PREVENTION AND CONTROL EUTICALS SPA SUMITOMO SEIKA CHEMICALS SUBJECT

4Q2012

OVERSIGHT, REVIEW, MONITORING, AND AUDITING PROCEDURES OF NATIONAL CANCER INSITUTE, DIVISION OF CANCER PREVENTION. TICLOPIDINE HYDROCHLORIDE, MANUFACTURED IN ROZZANO-(MI) MANUFACTURING SITE , FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN HYOGO, JAPAN. 2,4-THIAZOLE WING ACID HOSU ACTIVE ESTER, MANUFACTURED IN HYOGO, JAPAN.2,4THIAZOLE WING ACID HOSU ACTIVE ESTER, MANUFACTURED IN HYOGO, JAPAN

TERAZOSIN HYDROCHLORIDE MONOHYDRATE, MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND. LORATADINE, MANUFACTURED IN HIMACHAL PRADESH, INDIA. FL2000TM 80UM HDPE (PRODUCT CODE 78-080-A-020-B), MANUFACTURED IN APELDOORN, THE NETHERLANDS TRIAZOLON, MANUFACTURED IN REGENSBURG, GERMANY PHARMACEUTICAL PLASTIC BOTTLES, MANUFACTURED IN QUEBEC, CANADA DOSING PIPETTE, MANUFACTURED IN DUDELDORF, GERMANY CODEINE PHOSPHATE, MANUFACTURED IN CAPE PROVINCE, SOUTH AFRICA. DICLOFENAC POTASSIUM, MANUFACTURED IN TAIWAN, R.O.C.DICFLOFENAC POTASSIUM, MANUFACTURED IN TAIWAN, R.O.C.. EYE-DROPPER 5, 11 AND 15ML, DROPPERS, CAPS, MANUFACTURED IN OFFRANVILLE, FRANCE. SABIC LDPE 2102TC32;, MANUFACTURED IN AA BEEK, THE NETHERLANDS. TRIENTINE HCL, MANUFACTURED IN RENSSELAER, N.Y. PHARMACEUTICAL COMPONENT, MANUFACTURED IN ODENSE S., DENMARK. ALFENTANIL HCL, MANUFACTURED IN WEST DEPTFORD, NEW JERSEY. MEGESTROL ACETATE, MANUFACTURED IN PAVIA-ITALY. METERED DOSE AEROSOL VALVE, MANUFACTURED IN LEICESTERSHIRE, GREAT BRITAIN. PVC COMPOUND, 8271 CLEAR 36, MANUFACTURED IN TIPTONVILLE, TENNESSEE. RANITIDINE HYDROCHLORIDE, MANUFACTURED IN CUDDALORE, INDIA. MARVYLAN S 5702,MANUFACTURED AT DSM POLYMERS IN BEEK, THE NETHERLANDS AND SAV MAZINGARBE IN BULLY LES MINES, FRANCE. TVSE, MANUFACTURED IN CLEVELAND, ENGLAND. PLASTIC MATERIALS, MANUFACTURED IN JALISCO, MEXICO. IBUPROFEN BULK DRUG, MANUFACTURED IN ANDHRA PRADESH, INDIA. METFORMIN HYDROCHLORIDE DRUG SUBSTANCE, MANUFACTURED IN MEYZIEU, FRANCE.

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4Q2012EXCEL DMF# 12671 12672 12673 I 12674 12675 12676 12677 I 12678 12679 12680 12681 I 12682 I 12683 A 12684 12685 I 12686 12687 12688 12689 12690 12691 12692 12693 A 12694 A 12695 12696 12697 12698 12699 12700 12701 12702 12703 A I A I I I A I A II II II II II III II II II 10/15/1997 10/15/1997 10/16/1997 10/15/1997 10/14/1997 10/10/1997 10/17/1997 10/15/1997 10/20/1997 FARMABIOS S P A INTERQUIM SA ALBEMARLE CORP DOCTOR REDDYS LABORATORIES LTD SOLVAY DUPHAR BV PECHINEY SOPLARIL FLEXIBLE EUROPE BACHEM AMERICAS INC LEO PHARMACEUTICAL PRODUCTS LTD TEVA PHARMACEUTICAL INDUSTRIES LTD II 10/9/1997 ASTRAZENECA AB A C I I I I A II II II III III II IV III 10/6/1997 10/8/1997 10/7/1997 9/26/1997 9/26/1997 10/9/1997 10/8/1997 10/8/1997 CAMBREX PROFARMACO MILANO SRL TEVA PHARMACEUTICAL INDUSTRIES LTD GILEAD SCIENCES INC BASF AKTIENGESELLSCHAFT BASF AKTIENGESELLSCHAFT SIEGFRIED CHEMIE AG LTD FUJI CHEMICAL INDUSTRY CO LTD BAYER MATERIALSCIENCE LLC I II I 9/30/1997 10/3/1997 INDUSTRIALE CHIMICA SRL TOKUYAMA CORP BUSPIRONE HYDROCHLORIDE, MANUFACTURED IN SARANNO, ITALY III 10/7/1997 V 6/16/1997 I I A III II II III 9/29/1997 10/2/1997 10/2/1997 9/30/1997 POLYMER COLOR INC CAMBREX KARLSKOGA AB SIFAVITOR SRL 3M PHARMACEUTICALS INC A I I II III II III 10/1/1997 9/30/1997 10/1/1997 10/3/1997 KIKKOMAN BIOCHEMIFA CO DRYCOLOR AB PRODOTTI CHIMICI DOTTORI RE SCHOTT PARENTA SYSTEMS STATUS Type SUBMIT DATE I I II II I 9/29/1997 9/23/1997 10/1/1997 HOLDER YAMASA CORP SINOVA PHARMACEUTICALS CO PTE LTD KIBUN FOOD CHEMIFA CO LTD SUBJECT SODIUM CITICOLINE, MANUFACTURED IN CHIBA-KEN, JAPAN. CAPTOPRIL, MANUFACTURED IN SINGAPORE, REPUBLIC OF SINGAPORE.

4Q2012

PLANT FACILITIES AND ORGANIZATION FOR MANUFACTURING SODIUMHYALURONATE OF PHARMACEUTICAL GRADE IN TOKYO, JAPAN. SODIUM HYALURONATE OF PHARMACEUTICS GRADE IN TOKYO, JAPAN. MASTERBACH PE 142306, MANUFACTURED IN MALMO, SWEDEN. CHENODIOL, (CHENODEOXYCHOLIC ACID), MANUFACTURED IN BASALUZZO, ITALY. PACKAGING MATERIAL, PREFILL SYRINGE, A COMBINATION PRODUCT, MANUFACTURED IN CLEONA, PA . WPC-116-P 33/1 WHITE COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS. ISOSORBIDE-5-MONONITRATE/LACTOSE MANUFACTURED IN KARLSKOGA, SWEEDEN. BETAXOLOL HYDROCHLORIDE, MANUFACTURED IN MILANO, ITALY.

3MVA15378 50 MCL SOLUTION VALVE, MANUFACTURED IN LOUGHBOROUGH, GREAT BRITAIN. BRISTOL MYERS SQUIBB COMPANY FACILITIES FOR PARENTERAL MANUFACTURING (BUILDING D) LOCATED IN MAYAGUEZ, PR. SCHOTT PHARMACEUTICAL PACKAGING INC GLASS PRODUCTS, MANUFACTURED IN CLEONA, PENNSYLVANIA

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN IBARAKI, JAPAN MIDAZOLAM BASE MANUFACTURED IN MILAN ITALY. MEGESTROL ACETATE, MANUFACTURED IN LERMA, EDO. MEXICO. PMPA GEL, MANUFACTURED AT DPT LABS, SAN ANTONIO, TEXAS. LURAN 388 S, MANUFACTURED IN LUDWIGSHAFEN, GERMANY. TERLURAN 958 I WHITE 00260, MANUFACTURED IN LUDWIGSHAFEN, GERMANY. PROPAFENONE HYDROCHLORIDE, MANUFACTURED IN ZOLFINGEN,SWITZERLAND FUJICALIN, MANUFACTURED IN TOYAMA, JAPAN TEXIN 5286, 5290, 5250, 6265, 5270, 5590, 5370, MANUFACTURED IN NEW MARTINSVILLE, WV. TEXIN 5370, MANUFACTURED IN ONTARIO, CANADA. TEXIN 5275, MANUFACTURED IN DORMAGEN, GERMANY. PRILOSEC MUPS TABLETS (OMEPRAZOLE MAGNESIUM) (ESUB), AS MANUFACTURED IN SODERTALJE, SWEDEN. MEDROXYPROGESTERONE ACETATE, MANUFACTURED IN PAVIA, ITALY. SODIUM CITICOLINE, MANUFACTURED IN BARCELONA SPAIN. ITRACONAZOLE, MANUFACTURED IN SOUTH HAVEN, MI DOMPERIDONE MALEATE, MANUFACTURED IN SRIKAKULAM DISTRICT, INDIA. LACTULOSE CRYSTALLINE, MANUFACTURED IN AMSTERDAM, THE NETHERLANDS. COLD-FORMED BLISTER; CEF60, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE. PEPTIDE KL4, ACETATE, MANUFACTURED IN TORRANCE, CALIFORNIA. BUMETANIDE PURE MICRONISED, MANUFACTURED IN DUBLIN, IRELAND. MEDROXYPROGESTERONE ACETATE, MANUFACTURED IN LERMA, EDO MEXICO

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4Q2012EXCEL DMF# 12704 I 12705 12706 12707 12708 12709 12710 12711 12712 12713 12714 12715 I 12716 12717 I 12718 12719 A 12720 12721 12722 12723 12724 I 12725 12726 A 12727 I 12728 I 12729 12730 12731 12732 12733 I 12734 I 12735 I 12736 C II 11/12/1997 TEVA PHARMACEUTICAL INDUSTRIES LTD I 11/10/1997 TEVA PHARMACEUTICAL INDUSTRIES LTD II 11/7/1997 WYCKOFF CHEMICAL CO INC A A A A II IV IV II I 11/7/1997 10/27/1997 10/27/1997 11/3/1997 11/11/1997 PHARMATECH INTERNATIONAL INC CAPSUGEL CAPSUGEL UNION QUIMICO FARMACEUTICA SA JANSSEN PHARMACEUTICA INC I 11/6/1997 CONTI BPC NVSA I 11/4/1997 VISTA PHARMACEUTICALS INC A II II 10/29/1997 10/31/1997 OMICRON QUIMICA SA ASTRAZENECA AB BISMUTH SUBCARBONATE, MANUFACTURED IN BARCELONA, SPAIN. I I I A II II II II II 10/29/1997 10/29/1997 11/5/1997 10/29/1997 10/20/1997 AMINO GMBH AMINO GMBH JOHNSON MATTHEY INC OMICRON QUIMICA SA KYOWA HAKKO KOGYO CO LTD I III III 10/22/1997 10/22/1997 G AND A PRINTERS LTD EXXONMOBIL CHEMICAL CO A II II 10/23/1997 10/21/1997 I A A A A I A I I I III II III III III III II III II II IV 10/11/1997 10/20/1997 10/20/1997 10/20/1997 10/20/1997 10/22/1997 10/21/1997 10/24/1997 10/24/1997 10/23/1997 10/20/1997 STATUS Type SUBMIT DATE II 10/21/1997 HOLDER SHANGHAI SHEN XING PHARMACEUTICAL FACTORY PECHINEY EMBALLAGE ALIMENTAIRE GAYLORD CHEMICAL CO LLC ALFATHERM SPA ALFATHERM SPA ALFATHERM SPA CRODA ADHESIVES LTD ESTEVE QUIMICA SA SABIC PETROCHEMICALS BV PFANSTIEHL LABORATORIES INC EDMOND PHARMA PEBOC DIVISION EASTMAN CHEMICAL (UK) LTD EXCELLA GMBH CHEMI SPA SUBJECT WARFARIN SODIUM, USP, MANUFACTURED IN SHANGHAI, CHINA PHARMACEUTICAL STRIP, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE

4Q2012

DIMETHYL SULFOXIDE (DMSO), USP GRADE, MANUFACTURED IN SLIDELL, LOUISIANA ALFAFORM K072, MANUFACTURED IN VARESE-ITALY. ALFAFORM K206, MANUFACTURED IN VARESE-ITALY ALFACLEAR OR K263, MANUFACTURED IN VARESE-ITALY CRODALAM 29-208/25-011, MANUFACTURED IN NEWARK, ENGLAND ENANAPRILAT, MANUFACTURED IN BARCELONA SPAIN SABIC LDPE 2201TH00; MANUFACTURED IN AA BEEK, THE NETHERLANDS INULIN, USP,MANUFACTURED IN WAUKEGAN, IL. CARTEOLOL HYDROCHLORIDE, MANUFACTURED IN PADERNO DUGNANO (MI), ITALY EASTMAN VITAMIN E TPGS 1000 MANUFACTURED IN NORTH WALES, UNITED KINGDOM BISOPROLOL HEMIFUMARATE, MANUFACTURED IN FEUCHT, GERMANY. DPPC (DIPALMITOYL-PHOSPHATATIDYLCHOLINE) MANUFACTURED IN FROSINONE, ITALY. PHARMACEUTICAL PACKAGING MATERIALS, MANUFACTURED IN KENT, ENGLAND SANTOPRENE THERMOPLASTIC RUBBER 8280 GRADE SERIES, MANUFACTURED IN AKRON OH, PENSACOLA FL, WADSWORTH OH, AND NEWPORT WALES UK L-VALINE, MANUFACTURED IN FRELLSTEDT, GERMANY N-ACETYL-L-TYROSINE, MANUFACTURED IN FRELLSTEDT, GERMANY LANTHANUM CARBONATE, MANUFACTURED IN WEST DEPTFORD, NEW JERSEY BISMUTH SUBCITRATE, MANUFACTURED IN BARCELONA, SPAIN. CITICOLINE MONOSODIUM SALT, MANUFACTURED IN YAMAGUCHI PREFECTURE, JAPAN.

OMEPRAZOLE MAGNESIUM,(DRUG SUBSTANCE) (ESUB) MANUFACTURED IN SODERTALJE, SWEDEN. MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PRO-CEDURES IN ANDHRA PRADESH, INDIA. MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN LANDEN, BELGIUM. MISOPROSTOL, MANUFACTURED IN FAIRFIELD, NEW JERSEY. GELATIN CAPSULES, MANUFACTURED IN PATHUMTHANI, THAILAND GELATIN CAPSULES MANUFACTURED IN WEST JAVA, INDONESIA. 2,4-WING ACTIVE ESTER, MANUFACTURED IN BARCELONA, SPAIN. MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN CORK, IRELAND. TRIMETHOPRIM, MANUFACTURED IN SOUTH HAVEN, MI AND BY THE PHARMACEUTICAL PRODUCTS OF INDIA LTD IN BOMBAY, INDIA. MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN BEER SHEVA, ISREAL. GABAPENTIN, MANUFACTURED IN BEER SHEVA, ISREAL. Page 371

4Q2012EXCEL DMF# 12737 12738 A 12739 I 12740 I 12741 I 12742 12743 12744 A 12745 I 12746 12747 A 12748 12749 12750 12751 12752 I 12753 12754 12755 I 12756 12757 12758 12759 12760 A 12761 12762 12763 12764 12765 I 12766 12767 A A II III 11/27/1997 12/3/1997 I A I A II II III III IV 11/20/1997 11/12/1997 11/26/1997 12/1/1997 10/20/1997 RHODIA CHIREX INC. ICN HUNGARY COMPANY LIMITED MYLAN TECHNOLOGIES INC LOPAREX BV N I A N II 11/25/1997 II II 11/20/1997 11/24/1997 NOT AN ASSIGNED NUMBER INDENA UK LTD CAMBREX PROFARMACO MILANO SRL NOT AN ASSIGNED NUMBER AVANTI POLAR LIPIDS INC I A III II II 11/6/1997 11/14/1997 11/21/1997 A A A I III II II III II 11/12/1997 11/18/1997 11/14/1997 10/10/1997 11/17/1997 CENTER PACKAGING INC FARMABIOS S P A DR REDDYS LABORATORIES LTD PECHINEY SOPLARIL FLEXIBLE EUROPE A II II 11/18/1997 11/17/1997 II 11/14/1997 ABBOTT LABORATORIES HOSP PRODUCTS DIV TARO PHARMACEUTICAL INDUSTRIES LTD CATALENT PHARMA SOLUTIONS LLC A I III III IV 11/12/1997 11/12/1997 11/14/1997 CENTER PACKAGING INC COURTALDS PACKAGING LIMITED ACG ASSOCIATED CAPSULES PRIVATE LTD II 10/10/1997 ORPHARM INC II 11/13/1997 FINORGA SA III 10/29/1997 STATUS Type SUBMIT DATE I II II 11/12/1997 11/11/1997 HOLDER SYLACHIM AMCOL HEALTH AND BEAUTY SOLUTIONS INC DUPONT POLYESTER FILMS SUBJECT AMISULPRIDE, MANUFACTURED IN MOURENX, FRANCE.

4Q2012

FLUOROURACIL IN ACRYLATES COPOLYMER, MANUFACTURED IN LAFAYETTE, LA. MELINEX 813, MANUFACTURED IN DUMFRIES, UNITED KINGDOM, ROZENBURG, THE NETHERLANDS AND WILMINGTON, USA N-(2-DEOXY-2-L-LEUCYLAMINO-B-D-GLUCOPYRANOSYL)-N-OCTADECYL-DODECANAMIDE, MANUFACTURED IN CHASS SUR RHONE, FRANCE. LEVOMETHADYL ACETATE HYDROCHLORIDE (LAAM HCL), MANUFACTURED IN HOUSTON TEXAS CP 20 PRESSURE SENSITIVE INNERSEAL LINER, MANUFACTURED IN BROOKLYN, NY. OPHTHALMIC BOTTLES, MANUFACTURED IN WREXAM, UNITED KINGDOM. EXCIPIENT HARD GELATIN CAPSULES SHELLS, MANUFACTURED IN MAHARASHTRA, INDIA MIDAZOLAM, MANUFACTURED IN NORTH CHICAGO,IL. WARFARIN SODIUM CLATHRATE, MANUFACTURED IN HAIFA BAY, ISRAEL RITONAVIR, 100MG NAD 200MG SOFT-GELATIN CAPSULE, MANUFACTURED IN ST.PETERSBURG, FL. CP 40 PRESSURE SENSITIVE INNERSEAL LINER, MANUFACTURED IN BROOKLYN NY. BETAMETHASONE VALERATE, MANUFACTURED IN PAVIR, ITALY. DOXAZOSIN MESYLATE, MANUFACTURED IN ANDHRA PRADESH, INDIA. COLD-FORMED BLISTER: CEF 100, MANUFACTURED IN BRIGNOUD CEDEX, FRANCE.

DSM PHARMA CHEMICALS NORTH AMERICA R-FLURBIPROFEN, MANUFACTURED IN SOUTH HAVEN, MI INC BASF AKTIENGESELLSCHAFT LUPOLEN 3220 F Q285, MANUFACTURED IN LUDWIGSHAFEN, GERMANY. EUTICALS SPA HAIMEN PHARMACEUTICAL FACTORY HYDROXYUREA, MANUFACTURED IN LODI, ITALY. IVERMECTIN, NON-STERILE BULK DRUG, MANUFACTURED IN ZHIJIANG PROVINCE, CHINA. PACLITAXEL, DRUG SUBSTANCE, MANUFACTURED IN HERTFORDSHIRE, ENGLAND LABETALOL HCL, MANUFACTURED IN MILANO, ITALY L-ALPHA-PHOSPHATIDYLCHOLINE (EGG, 95%), MANUFACTURED IN ALABASTER, ALABAMA. CEP-701, MANUFACTURED IN MALVERN, PA. HYDROXYCHLOROQUINE SULFATE, MANUFACTURED IN KABAY J., HUNGARY MEDIIRELEASE 2500, RELEASE LINER MATERIAL, MANUFACTURED IN ST. ALBANS, VT. FL2000 PET 75U-1S, MANUFACTURED IN APELDOORN, THE NETHER- LANDS.

TECHNOLOGY FLAVORS AND FRAGRANCES NATURAL MASKING FLAVOR 777-185, MANUFACTURED IN AMITYVILLE, NEW YORK. INC YAMASA CORP RIBAVIRIN, MANUFACTURED IN CHIBA-KEN, JAPAN. PLASTICS COLOR CORP APEC 17530 COLOR CONCENTRATE, MANUFACTURED IN ASHEBORO, NORTH CAROLINA.

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4Q2012EXCEL DMF# 12768 I 12769 12770 A 12771 12772 I 12773 12774 I 12775 12776 A 12777 I 12778 I 12779 12780 12781 I 12782 12783 A 12784 12785 I 12786 I 12787 12788 A 12789 12790 12791 A 12792 12793 12794 12795 12796 12797 A I I I I I II II II II II II 12/15/1997 12/17/1997 12/9/1997 12/18/1997 12/15/1997 12/22/1997 SCHERING AG ARENOL CHEMICAL CORP QUIMICA FINA FARMEX SA DE CV AVENTIS PHARMA DEUTSCHLAND GMBH ORGAMOL SA LONZA BRAINE SA I I IV II IV 12/17/1997 12/11/1997 12/17/1997 RITA CORP TRIQUIM SA PFIZER INC A IV III 12/9/1997 12/15/1997 MINGTAI CHEMICAL CO LTD 3M DRUG DELIVERY SYSTEMS II 12/9/1997 SUMITOMO SEIKA CHEMICALS CO LTD A II I 12/12/1997 12/9/1997 CIPLA LTD SUMITOMO SEIKA CHEMICALS CO LTD I II V 12/12/1997 12/12/1997 A A III II II 12/5/1997 12/10/1997 12/12/1997 AIRSEC SA WOCKHARDT LTD ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV VIRCO BVBA MALLINCKRODT INC II 12/10/1997 ORGANICS LAGRANGE INC II 12/8/1997 FLURA CORPORATION I II V 12/2/1997 12/2/1997 I II II 12/5/1997 12/5/1997 MALLINCKRODT INC RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA POLYPEPTIDE LABORATORIES AS UNIV BRITISH COLUMBIA I III II 12/1/1997 12/1/1997 CAP LINER INC LONZA INC POLYETHYLENE CAP LINER (CL-101), MANUFACTURED IN FREEPORT, NY. A II II 11/25/1997 12/3/1997 MALLINCKRODT INC APOTEX PHARMACHEM INC STATUS Type SUBMIT DATE III 11/25/1997 HOLDER 3M PHARMACEUTICALS INC SUBJECT

4Q2012

M3647 25MCL COLD FILL VALVE, MANUFACTURED IN LOUGHBOROUGH, GREAT BRITAIN. METHYLPHENIDATE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ST. LOUIS, MO. PAROXETINE HYDROCHLORIDE (ANHYDROUS), MANUFACTURED IN ONTARIO, CANADA.

[3-(4-BROMOBENZYL)-2-BUTYL-5-CHLORO-3H-IMIDAZOL-4-YL]METHANOL, (MEOL), MANUFACTURED IN CONSHOHOCKEN, PA. CT50034, MANUFACTURED IN ST.LOUIS, MO. FLUOXETINE HCL USP, MANUFACTURED IN LATINA, ITALY. CALCITONIN (SALMON), PH.EUR.,MANUFACTURED IN HILLEROD, DENMARK. TECHNIQUES TO EVALUATE MAGNETIC RESONANCE IMAGING (MRI) IN VANCOUVER CANADA. PERFLUOROPROPANE (OCTAFLUOROPROPANE) GAS, MANUFACTURED IN NEWPORT, TN. ACTIVE PHARMACEUTICAL INGREDIENT-ESTERIFIIED ESTROGENS USP, MANUFACTURED IN CHICAGO,ILLINOIS. STANDARD DESICCATOR CAPSULES, MANUFACTURED IN ROMORANTIN, FRANCE. ENALAPRIL MALEATE, MANUFACTURED IN GUJARAT STATE , INDIA. NIKKOMYCIN Z HYDROCHLORIDE, MANUFACTURED IN NORTH CHICAGO, IL. KETOROLAC TROMETHAMINE, MANUFACTURED BY SICOR SA IN LAMAY, FRANCE. DESCRIBING THE QUALIFICATIONS OF AN EXPANDED ASEPTIC PROCESSING AREA (ESUB) IN MARYLAND HEIGHTS, MISSOURI DOXAZOSIN MESYLATE (ESUB) MANUFACTURED IN MAHARASHTRA, INDIA. MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES A BEFU WORKS IN HYOGO, JAPAN. 2-BROMO-1-[(4-METHYL SULFONYL) PHENYL] ETHANONE, MANUFACTURED IN HYOGO, JAPAN. CROSCARMELLOSE SODIUM NF (PROCESS I) ,MANUFACTURED IN TAIWAN, R O C. ACTUATORS AND DUST CAPS FOR CFC INHALATION AEROSOLS, MANUFACTURED IN CHINO AND CORONA, CALIFORNIA. FOR 3M PHARMACEUTICALS INC LANOLIN, MANUFACTURED IN CHICAGO, IL. FLUTAMIDE, MANUFACTURED IN MUNRO, ARGENTINA. SULPHOBUTYLETHER BETA-CYCLODEXTRIN (SBECD), MANUFACTURED BY ABBOTT LABORATORIES IN NORTH CHICAGO,IL. EOB-DTPA, MANUFACTURED IN BERLIN,GERMANY 4-HYDROXYANISOLE, MANUFACTURED IN SOMERVILLE, NJ KETOCONAZOLE, MANUFACTRRED IN QUERETARO, MEXICO HMR 1275, MANUFACTURED IN FRANKFURT, GERMANY. PEMOLINE, MANUFACTURED IN EVIONNAZ, SWITZERLAND. HIRULOG (BIVALIRUDIN)- ACTIVE PHARMACEUTICAL INGREDIENT, MANUFACTURED IN BRAINE-L' ALLEUD (BELGIUM).

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4Q2012EXCEL DMF# 12798 12799 12800 I 12801 12802 I 12803 C 12804 I 12805 A 12806 12807 A 12808 12809 12810 12811 12812 12813 12814 I 12815 I 12816 12817 12818 12819 I 12820 12821 12822 I 12823 I 12824 I 12825 I 12826 12827 12828 I A A II II V 1/20/1998 1/21/1998 10/31/1997 JANSSEN PHARMACEUTICA NV CIPLA LTD GREER LABORATORIES INC I 1/21/1998 ANALYTICON AG IV 1/19/1998 FONA INTERNATIONAL INC I 1/19/1998 MATRIX PACKAGING INC I I II III III 1/16/1998 1/9/1998 1/19/1998 ESTEVE QUIMICA SA ROLLPRINT PACKAGING PRODUCTS INC 3M PHARMACEUTICALS INC I I A II III II II 1/7/1998 1/9/1998 1/7/1998 2/5/1997 I 1/7/1998 I A I I A A II II III III III II II 12/23/1997 12/29/1997 12/19/1997 12/18/1997 12/30/1997 1/5/1998 1/6/1998 I II II 12/24/1997 12/17/1997 URQUIMA SA PRIME EUROPEAN THERAPEUTICS SPA EUTICALS SPA ELAN PHARMA LTD KRKA DD NOVA MESTO MICHELMAN INC RAKU GMBH BERRY PLASTICS CORPORATION FARMABIOS S P A IV 12/15/1997 STEPAN CO I 12/16/1997 NOVARTIS PHARMACEUTICALS CORP II 12/22/1997 I III II 12/23/1997 12/22/1997 ROHM AND HAAS CO BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI SPA CHEMWERTH INC STATUS Type SUBMIT DATE I A II II III 12/22/1997 12/22/1997 11/7/1997 HOLDER LA JOLLA PHARMACEUTICAL CO GUFIC BIOSCIENCES LTD RISDON SA SUBJECT LJP 394 DRUG SUBSTANCE, MANUFACTURED IN SAN DIEGO, CALIFORNIA. ECONAZOLE NITRATE USP, MANUFACTURED IN GUJARAT STATE, INDIA CAPS (BLUE AND TAN BROWN COLORS) FOR EYE-DROPPERS BOTTLES, MANUFACTURED IN OFFRANVILLE, FRANCE. EMULSION E-2920 (7-1946), MANUFACTURED IN PHILADELPHIA, PA. TERAZOSIN HCL 2H20, MANUFACTURED IN FRESONARA (AL)-ITALY.

4Q2012

DISODIUM PAMIDRONATE (ANHYDROUS FORM), MANUFACTURED IN NEWBURYPORT, MA FOR CHEMWERTH INC MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN STEIN, SWITZERLAND. NEOBEE M-20, PROPYLENE GLYCOL DI(CAPRYLATE/CAPRATE), MANUFACTURED IN MAYWOOD, NJ. FLUTRIMAZOLE, MANUFACTURED IN BARCELONA, SPAIN. FLUTAMIDE USP, MANUFACTURED IN ORRIGIO, ITALY. MORPHINE SULFATE, MANUFACTURED IN COUNTY WESTMEATH, IRELAND ENALAPRIL MALEATE, MANUFACTURED IN SLOVENIA, EUROPE. MICHEM LUBE 160, MANUFACTURED IN CINCINNATI, OH. EXTRUSION MOLD BOTTLE 3097 (R), MANUFACTURED IN RASTATT, GERMANY. PLASTIC PACKAGING PRODUCTS, MANUFACTURED IN HOT SPRINGS, ARKANSAS. BECLOMETHASONE DIPROPIONATE, MANUFACTURED IN PAVIA, ITALY.

ZHEJIANG HISUN PHARMACEUTICAL CO LTD BLEOMYCIN A2 AND B2/COPPER COMPLEX, NON-STERILE BULK DRUG SUBSTANCE, MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. HALCYON LABS PRIVATE LTD MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERANING PROCEDURES IN AHMEDABAD, INDIA. HALCYON LABS PVT LTD TRIMETHOPRIM USP, MANUFACTURED IN AHMEDABAD, INDIA DUDEK PLAST AS SANOFI AVENTIS CHIMIE KURARAY CO LTD DUDEK CONTAINERS, MANUFACTURED IN JONSTRUP, DENMARK. APOMORPHINE HYDROCHLORIDE, MANUFACTURED IN ARAMON, FRANCE (1S,3R,20S)-20-(3-HYDROXY-3-METHYLBUTLOXY) PREGNA-5,7-DIENE-1,3-DIOL, MANUFACTURED IN NIIGATA, JAPAN CIZOLIRTINE CITRATE, MANUFACTURED IN BARCELONA SPAIN. RPPP #36-1080A, MANUFACTURED IN ADDISON, ILLINOIS CP-325,366 METERED DOSE INHALER CONTAINER CLOSURE SYSTEM, MANUFACTURED IN LEICESTERSHIRE, ENGLAND. MANUFACTURING SITE, FACILITIES, PERSONNEL, OPERATING PROCEDURES IN ONTARIO, CANADA. #815.089 N-C BUBBLEGUM FLAVOR (A NATURAL FLAVOR),MANUFACTURED IN CAROLSTREAM, ILLINOIS. MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN POTSDAM, GERMANY. R108512 DRUG SUBSTANCE, MANUFACTURED IN BEERSE,BELGIUM. OMEPRAZOLE (ESUB) MANUFACTURED IN BANGALORE,INDIA. STERILE PRODUCTS FACILITY IN LENOIR, NC.

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4Q2012EXCEL DMF# 12829 A 12830 12831 12832 12833 I 12834 12835 12836 I 12837 I 12838 A 12839 I 12840 12841 12842 I 12843 I 12844 I 12845 I 12846 12847 12848 A 12849 12850 I 12851 12852 12853 12854 12855 I I A I II IV III II II 2/5/1998 2/4/1998 2/11/1998 2/10/1998 2/6/1998 FERRO PFANSTIEHL INC MASTERTASTE INC SHOWA DENKO PACKAGING CORP ASTELLAS PHARMA INC PHARMA ECO LABORATORIES INC DECITABINE, MANUFACTURED IN WAUKEGAN,IL. NA CHERRY WONF 606007, MANUFACTURED IN TETERBORO, NEW JERSEY. HARD PACK, MANUFACTURED IN SHIGA, JAPAN YM087 DRUG SUBSTANCE, MANUFACTURED IN IBARAKI-KEN, JAPAN. I II III 2/6/1998 1/27/1998 I I III III II 2/2/1998 1/27/1998 2/5/1998 POLIMERI EUROPA BASF AKTIENGESELLSCHAFT JOHNSON MATTHEY PHARMACEUTICAL MATERIALS ROBERTS LABORATORIES INC SOLVIN SA III 1/30/1998 OWENS ILLINOIS CLOSURE INC III 1/29/1998 AMPACET CORP III 1/29/1998 AMPACET CORP I I II IV III 2/2/1998 1/27/1998 1/29/1998 SANOFI AVENTIS SPA MONA INDUSTRIES INC AMPACET CORP III 1/23/1998 VIANOVA RESINS GMBH II 1/29/1998 CATALENT PHARMA SOLUTIONS LLC III 1/21/1998 PET TECHNOLOGIES LTD A I II II II 1/30/1998 1/16/1998 1/16/1998 I A I II III II II 1/23/1998 12/22/1997 1/29/1998 1/30/1998 WYCKOFF CHEMICAL CO INC JS PLASTICS INC HOSPIRA INC STATUS Type SUBMIT DATE II 1/23/1998 HOLDER CORDEN PHARMA LATINA SPA SUBJECT

4Q2012

PIPERACILLIN MONOHYDRATE (ESUB) AS MANUFACTURED IN SERMONETA, LATINA, ITALY. TRAMADOL HYDROCHLORIDE, MANUFACTURED IN SOUTH HAVEN, MI. EXTRUSIONS AND COEXTRUSIONS, MANUFACTURED IN NAPERVILLE, IL. LAMISIL EMULSION, MANUFACTURED IN CLAYTON, NC

LIANYUNGANG PHARMACEUTICAL FACTORY METHOTREXATE USP, NON-STERILE BULK DRUG, MANUFACTURED IN JIANGSU PROVINCE, CHINA KISSEI PHARMACEUTICAL CO LTD KAD-1229, MANUFACTURED IN HYOGO PREFECTURE, JAPAN BIOCLONES PTY LTD BIOCLONES PTY LTD POLY RIBOINOSINIC ACID (POLY [I]), MANUFACURED IN CAPE TOWN, SOUTH AFRICA POLY RIBOCYTIDYLIC/URIDYLIC ACID (POLY [C12U]), MANUFACTURED IN CAPE TOWN, SOUTH AFRICA POLYETHYLENE TEREPHTHALATE PACKAGING MATERIALS MANUFACTURED IN OXFORD, ENGLAND 1-ALPHA-HYDROXYVITAMIN D2 2.5-UG SOFT-GELATIN CAPSULES MANUFACTURED IN ST. PETERSBURG, FL COATINGS FOR PHARMACEUTICAL PACKAGING ALRESEN PA 101, MANUFACTURED IN WIESBADEN, GERMANY OXYBUTYNIN CHLORIDE, MANUFACTURED IN GARESSIO,ITALY MONAMID 150-LWA, MANUFACTURED IN PATERSON, NEW JERSEY 10407 UV POLYETHELYNE MASTERBACH, MANUFACTURED IN TERRE HAUTE, IN, CARTERSVILLLE, GA, AND DERIDDER LA. 16027 BLUE UV POLYETHYLENE MASTERBACH, MANUFACTURED IN TERRE HAUTE,IN, CARTERSVILLE,GA, AND DERIDDER.LA. 19699 BLACK POLYETHYLENE MASTERBATCH MANUFACTURED IN TERRE HAUTE,IN, CATERSVILLE,GA, AND DERIDDER,LA. INJECTION MOLDING OPERATION MED-TIME CLOSURES, MAN UFACTURED IN EL PASO, TEXAS. CLEARGLEX FH 50, MANUFACTURED IN MILAN,ITALY. ULTRAFORM S1320 003, MANUFACTURED IN LUDWIGSHAFEN, GERMANY. HYDROCODONE BITARTRATE, USP MANUFACTURED IN WEST DEPTFORD, NEW JERSEY. STANATE (STANNSOPORFIN) INJECTION, MANUFACTURED IN BEDFORD,OH. IXAN PA 350 PVDC AQUEOUS DISPERSION, MANUFACTURED IN TAVAUX CEDEX,FRANCE.

I 12856 12857 A A II II 2/11/1998 2/17/1998 ASTELLAS PHARMA INC SIFAVITOR SRL

5-(2,3-DICHLOROBENZOYLAMINO)-3-[4-(N-{5-(2,4-DICHLOROBENZOYLAMINO)-4-OXO-3,4DIHYDRO-2,7-DISULFONAPHTHALENE-3-YLIDENE}HYDRAZINO)-2,5-DIMETHOXYPHENYLHDYRAZONO]-4-OXO-3,4-DIHYDRONAPHTHALENE-2,7-DISULFONIC ACID TETRASODIUM SALT. FK463, MANUFACTURED IN NISHIKASUGAIGUN,JAPAN ECONAZOLE NITRATE, MANUFACTURED IN LODI, ITALY.

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4Q2012EXCEL DMF# 12858 12859 A 12860 12861 12862 A 12863 12864 I 12865 A 12866 A 12867 12868 12869 A 12870 12871 12872 A 12873 I 12874 12875 12876 12877 12878 12879 12880 I 12881 12882 12883 I 12884 12885 A 12886 A 12887 12888 12889 A A A II III III 2/19/1998 3/6/1998 3/5/1998 II 2/28/1998 A III II 2/27/1998 2/4/1998 HB FULLER CO INDUSTRIAS QUIMICAS KIMITSU CHILE Y CIA LTDA SUZHOU NUMBER 4 PHARMACUTICAL FACTORY ALBEMARLE CORP 3M DRUG DELIVERY SYSTEMS 3M DRUG DELIVERY SYSTEMS I I II II II 2/25/1998 2/27/1998 3/2/1998 FUJIMOTO CHEMICALS CO LTD BRISTOL MYERS SQUIBB COMPANY JAPAN TOBACCO INC I I A A I A II III II III III II II 2/23/1998 2/20/1998 2/23/1998 2/23/1998 12/8/1997 2/26/1998 12/17/1997 II 2/22/1998 HUIZHOU DONGJIANG PHARMACEUTICAL FACTORY GUANGDONG REPLIGEN CORP RIFLEX FILM AS INDENA SPA DRUG PLASTICS CLOSURES INC POWDERJECT TECHNOLOGIES INC ROQUETTE FRERES MILLIPORE CORP A I II II V 2/20/1998 2/20/1998 1/28/1998 SA AJINOMOTO OMNICHEM NV MALLINCKRODT INC JANSSEN DIAGNOSTICS BVBA I I II II II 2/13/1998 2/17/1998 2/18/1998 II 2/9/1998 SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL KATSURA CHEMICAL CO LTD PARTICLE DYNAMICS CO EXCELLA GMBH III 1/1/1998 I II II 2/13/1998 2/17/1998 I I III III II 2/11/1998 2/11/1998 2/13/1998 TARGOR GMBH F 206 TARGOR GMBH HERAEUS PRECIOUS METALS GMBH AND CO KG BOEHRINGER INGELHEIM PHARMA KG HENAN KAIFENG PHARMACEUTICAL FACTORY UNITED CLOSURES AND PLASTICS PLC STATUS Type SUBMIT DATE I II IV 2/11/1998 2/15/1998 HOLDER J K PHARMACHEN LIMITED FARMACAPSULAS DE COLUMBIA SA SUBJECT PENICILLIN G POTASSIUM, MANUFACTURED IN TAMIL NADU, INDIA. EXCIPIENT EMPTY HARD GELATIN CAPSULES SHELLS, MANUFACTURED IN BARRANQUILLA, COLUMBIA NOVOLEN 1170 L, MANUFACTURED IN LILLEBONNE,FRANCE. NOVOLEN 1170 PC, MANUFACTURED IN LILLEBONNE, FRANCE. DACARBAZINE, USP MANUFACTURED IN HANAU, GERMANY. MOXONIDINE, MANUFACTURED IN INGELHEIM/RHEIN GERMANY. DOXYCYCLINE HYDROCHLORIDE, MANUFACTURED IN HENAN, CHINA.

4Q2012

28MM AND 33MM STANDARD TAMPER-EVIDENT CLIC-LOC III CLOSURE, MANUFACTURED IN NORWICH, ENGLAND. CLONIDINE BASE, MANUFACTURED IN REGGELLO, ITALY. BTA, MANUFACTURED IN KANAGWA, JAPAN. DESTAB MAGNESIUM CARBONATE 90, MANUFACTURED IN MIDDLESEX, NEW JERSEY. TRAMADOL HYDROCHLORIDE, MANUFACTURED IN FEUCHT, FEDERAL REPUBLIC OF GERMANY. IRBESARTAN CRUDE, MANUFACTURED IN WETTEREN, BELGIUM. PENTAZOCINE HYDROCHLORIDE USP, MANUFACTURED IN ST. LOUIS, MO. ANTIVIROGRAM (DOCUMENT IDENTIFICATION: VIRCO/FDA/98001) IN MECHELEN, BELGIUM. CLOZAPINE, USP, MANUFACTURED IN GUANGDONG PROVINCE, CHINA. IMMOBILIZED PROTEIN A IPA-400HC, MANUFACTURED IN NEEDHAM, MASSACHUSETTS. NON-SOFTENED PVC FILMS (RIFLEX), MANUFACTURED IN HALDEN, NORWAY. PACLITAXEL, MANUFACTURED IN SETTALA (MI)- ITALY PLASTIC CLOSURES, MANUFACTURED IN PHOENIX, AZ AND EDINBURG, IN. DERMAL POWDERJECT DELIVERY SYSTEM, MANUFACTURED IN BURLINGAME, CA. MANNITOL USP GRADE, MANUFACTURED IN LESTREM, FRANCE. STERISCREEN RAPID MICRO SCREENING SYSTEM, MANUFACTURED BY CELSIS LUMAC BV IN LANDGRAAF, THE NETHERLAND. BIS-THP PGE1, MANUFACTURED IN HYOGO, JAPAN IRBESARTAN, MANUFACTURED IN HUMACAO, PUERTO RICO JTE-522 DRUG SUBSTANCE, A NEW CYCLOOXYGENASE-2 (COX-2) INHIBITOR, MANUFACTURED A FUJI CHEMICALINDUSTRY, CO., LTD IN TOYAMA, JAPAN HL-0916-S, MANUFACTURED IN QUEBEC, CANADA SODIUM ALGINATE, ALGINIC ACID, MANUFACTURED IN LAS COLONIAS PAINE, CHILE CLINDAMYCIN HYDROCHLORIDE ETHANOLATE INTERMEDIATE, MANUFACTURED IN JIANSGU PROVINCE, CHINA TERCONAZOLE, MANUFACTURED IN SOUTH HAVEN, MI M3659 50 MCL COLD FILL VALVE, MANUFACTURED IN LEICESTERSHIRE, ENGLAND. M3665 50 MCL COLD FILL VALVE, MANUFACTURED IN LEICESTERSHIRE, ENGLAND.

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4Q2012EXCEL DMF# 12890 12891 12892 12893 A 12894 I 12895 A 12896 12897 12898 I 12899 12900 A 12901 12902 12903 12904 12905 12906 12907 12908 12909 I 12910 12911 12912 12913 A 12914 A 12915 12916 12917 12918 12919 I 12920 12921 12922 12923 I I A I II II II III 4/7/1998 3/27/1998 4/2/1998 3/16/1998 GEDEON RICHTER LTD ABBOTT LABORATORIES LTD TRIFARMA SPA SOLVAY SA CDB-2914, MANUFACTURED IN BUDAPEST AND DOROG, HUNGARY BUTORPHANOL TARTRATE USP, MANUFACTURED IN KENT, UNITED KINGDOM CLINDAMYCIN PHOSPHATE USP, MANUFACTURED IN MILANO, ITALY IXAN PVDC PA 121, MANUFACTURED IN TAVAUX CEDEX, FRANCE A I A I II II II II II 3/25/1998 3/26/1998 3/25/1998 3/26/1998 3/27/1998 II 3/17/1998 MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH LUBRIZOL ADVANCED MATERIALS INC SANOFI SYNTHELABO INC. DR REDDYS LABORATORIES LTD CHUGAI PHARMACEUTICAL CO LTD ASAHI GLASS CO LTD I A I II II II II 3/23/1998 3/6/1998 1/26/1998 3/10/1998 DIOSYNTH BV FIDIA FARMACEUTICI SPA GEDEON RICHTER LTD MALLINCKRODT INC A I A I A A A A II II II II III III III III IV 3/17/1998 3/18/1998 3/10/1998 3/18/1998 3/18/1998 3/18/1998 3/18/1998 3/18/1998 3/19/1998 SANDOZ PRIVATE LTD PENINSULA LABORATORIES INC ROHM AND HAAS CO TORRENT GUJARAT BIOTECH LTD BORMIOLI ROCCO SPA BU PLASTICS BORMIOLI ROCCO SPA BU PLASTICS BORMIOLI ROCCO SPA BU PLASTICS BORMIOLI ROCCO SPA BU PLASTICS FONA INTERNATIONAL INC A II IV 3/16/1998 3/17/1998 PIERRE FABRE MEDICAMENT QUALICAPS CO LTD A I II III IV 3/12/1998 3/16/1998 3/19/1998 TRIFARMA SPA MOLDEX PRODUCTS INC FONA INTERNATIONAL INC II 3/11/1998 RANBAXY LABORATORIES LTD II 3/11/1998 RANBAXY LABORATORIES LTD STATUS Type SUBMIT DATE I I I II II II IV 3/6/1998 3/6/1998 3/6/1998 3/9/1998 HOLDER ARCHER DANIELS MIDLAND CO NATCO PHARMA LTD NATCO PHARMA LTD FUJI CHEMICAL INDUSTRY CO LTD SUBJECT TOCOPHEROL, MANUFACTURED IN DECATUR, IL NAPROXEN, USP, MANUFACTURED IN ANDHRA PRADESH, INDIA NAPROXEN SODIUM, USP, MANUFACTURED IN ANDHRA PRADESH, INDIA

4Q2012

NEUSILIN MAGNESIUM ALUMINOMETASILICATE, MANUFACTURED IN TOYAMA PREF., JAPAN CEFADROXIL USP, HEMIHYDRATE, (NON-STERILE BULK), MANUFACTURED IN PUNJAB, INDIA AMOXICILLIN USP, TRIHYDRATE, (NON-STERILE BULK), MANUFACTURED IN PUNJAB, INDIA FUROSEMIDE, MANUFACTURED IN MILANO-ITALY MONO PVC FILMS, MANUFACTURED IN QUEZON CITY, PHILIPPINES #918.005 SWEET-AM POWDER (A NATURAL FLAVOR), MANUFACTURED IN CAROL STREAM, ILLINOIS IDAZOXAN HYDROCHLORIDE, MANUFACTURED IN GAILLAC CEDEX, FRANCE HYDROXYPROPYL METHYCELLULOSE CAPSULE (HPMC CAPSULE), MANUFACTURED IN NARA, JAPAN PYRILAMINE MALEATE USP, MANUFACTURED IN MUMBAI, INDIA MET-ENKEPHALIN DRUG SUBSTANCE, MANUFACTURED IN SAN CARLOS, CALIFORNIA AMBERLITE IRP64, MANUFACTURED IN CHAUNY CEDEX, FRANCE AMOXICILLIN, USP, MANUFACTURED IN GUJARA, INDIA HDPE BOTTLE 60ML, MANUFACTURED IN CASTELGUELFO, ITALY HDPE BOTTLE 80ML, MANUFACTURED IN CASTELGUELFO, ITALY HDPE BOTTLE 120ML, MANUFACTURED IN CASTELGUELFO, ITALY HDPE BOTTLE 150ML, MANUFACTURED IN CASTELGUELFO, ITALY #884.010 N-C NATURAL & ARTIFICIAL ORANGE FLAVOR, MANUFACTURED IN CAROL STREAM, ILLINOIS MIDAZOLAM, MANUFACTURED IN APELDOORN, THE NETHERLAND OXAPROZIN, MANUFACTURED IN MULAZZANO, ITALY LISINOPRIL, MANUFACTURED IN BUDAPEST, HUNGARY OPTISON (ESUB) MANUFACTURED IN MARYLAND HEIGHTS, MO TREOSULFAN (ESUB) MANUFACTURED BY DYNAMIT NOBEL GMBH ES LEVERKUSEN, GERMANY CARBOPOL ETD 2050, MANUFACTURED IN CALVERT CITY,KY R-ZACOPRIDE, MANUFACTURED IN GARGENVILLE, FRANCE OMEPRAZOLE, USP, MANUFACTURED IN ANDHRA PRADESH, INDIA OCT (MAXACALCITOL), MANUFACTURED IN SHIZUOKE PREFECT, JAPAN 4'-BROMOMETHY1-2-CYANOBIPHENYL (CPB-2), MANUFACTURED IN KANAGAWA, JAPAN

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4Q2012EXCEL DMF# 12924 12925 I 12926 I 12927 12928 I 12929 12930 12931 A 12932 12933 12934 12935 I 12936 12937 12938 A 12939 12940 I 12941 12942 12943 I 12944 12945 12946 12947 12948 12949 12950 12951 12952 A 12953 I 12954 12955 12956 I I A II III I 4/21/1998 4/17/1998 4/9/1998 III 4/15/1998 TECHNICAL COATINGS CO SUB BENJAMIN MOORE AND CO GUILFORD PHARMACEUTICALS INC REXAM HEALTHCARE PACKAGING INC VIVIMED LABS LTD I A A I N A A I II III II III 4/13/1998 4/8/1998 4/17/1998 4/16/1998 II II II II 4/9/1998 4/6/1998 4/7/1998 4/13/1998 JOHNSON MATTHEY INC LUBRIZOL ADVANCED MATERIALS INC YMC CO LTD ADVANCED CHEMTECH INC NOT AN ASSIGNED NUMBER EUTICALS SPA CODING PRODUCTS HAMILTON PHARMACEUTICALS, INC. 3M DRUG DELIVERY SYSTEMS CYCLOSPORINE, MANUFACTURED IN MILAN, ITALY SV-13916, A HOT STAMP INK RIBBON, MANUFACTURED IN MILAN, ITALY I I III II III 4/8/1998 4/7/1998 4/8/1998 WEST PHARMACEUTICAL SERVICES INC CHEMSOURCE CORP COURTESY MED TEK I II III 4/8/1998 4/9/1998 GEDEON RICHTER LTD DSM RESINS US INCORPORATED I A III II II 3/24/1998 4/3/1998 4/8/1998 RESCO COLOURS INC SCHERING CORP CATALENT PHARMA SOLUTIONS LLC C I I II II II I 4/2/1998 3/31/1998 3/20/1998 4/3/1998 TEVA PHARMACEUTICAL INDUSTRIES LTD SMITHKLINE BEECHAM YANGZHOU PHARMACEUTICAL FACTORY MIPHARM SPA I I II III II 3/30/1998 3/23/1998 4/1/1998 PCAS RESCO COLOURS INC ASH STEVENS INC I II I 3/31/1998 3/23/1998 II 3/2/1998 STATUS Type SUBMIT DATE A II V 3/26/1998 3/31/1998 HOLDER LUBRIZOL ADVANCED MATERIALS INC HONG KONG INSTITUTE BIOTECHNOLOGY LTD MARUTI SYNTHETICS AND PHARMACEUTICALS LTD GUILFORD PHARMACEUTICALS INC BANYON CHEMICALS PRIVATE LIMITED SUBJECT CARBOPOL ETD 2020, MANUFACTURED IN CALVERT CITY, KY STERILE PROCESSING FACILITY LOCATED IN HONG KONG, CHINA GLYCINE (AMINO ACETIC ACID), MANUFACTURED IN TAMIL NADU, INDIA GPI 202, MANUFACTURED IN BALTIMORE, MARYLAND

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN GUJARA, INDIA MIDAZOLAM BASE, MANUFACTURED IN LIMAY, FRANCE CUSTOM COLOR/ADDITIVE CONCENTRATE, MANUFACTURED IN ONTARIO, CANADA SS-2'-DEOXY-5-FLUOROURIDINE ACTIVE PHARMACEUTICAL INGREDIENT, MANUFACTURED IN DETROIT AND RIVERVIEW, MI CYCLOSPORINE, MANUFACTURED IN OPAVA, CZECH REPUBLIC 6-AMINOPENICILLANIC ACID [6-APA], MANUFACTURED IN SCOTLAND,UK LEVONORGESTREL USP 23, MANUFACTURED IN JIANGSY PROVINCE, CHINA MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN MILANO, ITALY 78MPT-466, MANUFACTURED IN OMTARIO, CANADA BETAMETHASONE, USP, MANUFACTURED IN SINGAPORE MICONAZOLE NITRATE (1,200MG) VAGINAL OVULE SOFT-GELATIN CAPSULE, MANUFACTURED IN ST. PETERSBURG, FL ENALAPRIL MALEATE, MANUFACTURED IN BUDAPEST, HUNGARY URAVER FB120 B-60, MANUFACTURED BY DSM KUNSTHARZE GMBH IN MEPPEN, GERMANY LYODRY DESICANT STOPPER, MANUFACTURED IN LIONVILLE, PA RANITIDINE HCI FORM 1 DRUG SUBSTANCE MANUFACTURED IN GUAYAMA, P.R. PART NUMBER D12001AA, LYO-CAP ASSEMBLY, MANUFACTURED IN BUFFALO GROVE, ILLINOIS MEPERIDINE HCI, USP, MANUFACTURED IN WEST DEPTFORD, NEW JERSEY CARBOPOL ULTREZ 10, MANUFACTURED IN CALVERT CITY, KY YMC*GEL, MANUFACTURED IN ISHIKAWA 923, JAPAN 802-2 SYNTHETIC PEPTIDE STERILE POWDER, MANUFACTURED IN LOUISVILLE, KY

NEFIRACETAM DRUG SUBSTANCE, MANUFACTURED IN AKITA-SHI AKITA, JAPAN CONTAINER-CLOSURE SYSTEM FOR NON-CFC INHALATION AEROSOLS, MANUFACTURED IN CLITHEROE, UK 7GZ216 TUBE SEALANT, MANUFACTURED IN NUTLEY, N.J. P(DAPG-EOP), MANUFACTURED IN BALTIMORE, MD SRB II CONTAINERS, MANUFACTURED IN BATTLBORO, NC MANUFACTURING SITES, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN (STATE OF KARNATAKA), INDIA Page 378

4Q2012EXCEL DMF# 12957 12958 I 12959 I 12960 12961 12962 A 12963 I 12964 12965 A 12966 A 12967 A 12968 12969 12970 I 12971 12972 I 12973 12974 12975 I 12976 12977 12978 I 12979 I 12980 I 12981 I 12982 12983 I 12984 I IV 5/7/1998 I II II 5/4/1998 4/27/1998 MUSASHINO CHEMICAL LABORATORY LTD BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG AMPACET CORP I 5/4/1998 MUSASHINO CHEMICAL LABORATORY LTD III 5/8/1998 DSM RESINS BV III 3/26/1998 SHIOTANI GLASS CO LTD A A II II I 4/30/1998 5/2/1998 4/30/1998 ACS DOBFAR SPA CADILA HEALTHCARE LTD JENAPHARM GMBH CO KG I A III II II 4/28/1998 4/24/1998 4/22/1998 ROLLPRINT PACKAGING PRODUCTS INC ROHM AND HAAS CO CUNO INC I III II 4/21/1998 4/30/1998 GEORGIA PACKAGING INC NANOSYSTEMS A I II II IV 4/24/1998 5/4/1998 4/29/1998 ESTEVE QUIMICA SA FUJISAWA PHARMACEUTICAL CO LTD FONA INTERNATIONAL INC IV 2/3/1998 MINGTAI CHEMICAL CO LTD IV 2/3/1998 MINGTAI CHEMICAL CO LTD A II III 4/27/1998 4/22/1998 III 4/20/1998 A I II IV II 4/24/1998 4/21/1998 4/24/1998 FERMION OY EASTMAN CHEMICAL CO II 4/20/1998 CUNO INC STATUS Type SUBMIT DATE A III V 4/22/1998 4/22/1998 HOLDER BAYER MATERIALSCIENCE LLC PPD PHARMACO INC SUBJECT MAKROLON 2458-1112 AND 1117, MANUFACTURED IN PITTSBURGH, PA

4Q2012

DETERMINATION OF ISDN, 2-ISMN AND 5-ISMN IN HUMAN PLASMA BY GAS LIQUID CHROMATOGRAPHY IN MIDDLETON, WI ZETA PLUS DELIPID FILTER MEDIUM (DEL3 FORMULATION), MANUFACTURED IN STAFFORD SPRINGS, CT LEVOSIMENDAN, MANUFACTURED IN OULU,FINLAND EASTMAN VITAMIN E TPGS 1000, MANUFACTURED IN ROCHESTER, NY

ZHEJIANG HISUN PHARMACEUTICAL CO LTD BLEOMYCIN SULFATE USP, NON-STERILE BULK DRUG, MANUFACTURED IN ZHEJIANG PROVINCE, CHINA AMPACET CORP 160638-A BLUE PA POLYETHLENE MASTERBACH, MANUFACTURED IN TERRE HAUTE, IN, CARTERSVILLE, GA AND DERIDDER, LA PCAS CLONIDINE BASE, MANUFACTURED IN TURKU, FINLAND ZELLER PLASTIK GMBH SCREW CLOSURE ND 20 WITH ZELSNAP SNAP HINGE, MANUFACTURED IN ZELL, GERMANY COMPRECEL MICROCRYSTALLINE CELLULOSE, TYPES M101, M102 ,M112, M113, M112D+ & M113D+, MANUFACTURED IN TAIWAN, ROC COMPRECEL MICROCRYSTALLINE CELLULOSE, TYPES M101D+, M102+, M103D+ & M105D+, MANUFACTURED IN TAIWAN, ROC. LISINOPRIL, MANUFACTURED IN BARCELONA, SPAIN FK317, MANUFACTURED IN NISHIKAKASUGAIGUN AICHI PREFECTURE, JAPAN #815.087 BUBBLEMINT FLAVOR (A NA. & ART. FLAVOR), MANUFACTURED IN CAROL STREAM, IL 15803-10, MANUFACTURED IN COLUMBUS, GA MK-869 ORAL NANOCRYSTAL COLLOIDAL DISPERSION, MANUFACTURED IN HORSHAM, PA RPP #26-1108 (PACKAGING MATERIAL), MANUFACTURED IN ADDISON, ILLINOIS AMBERLITE IRP70, MANUFACTURED IN CHAUNY CEDEX, FRANCE ZETA PLUS DELIPID FILTER MEDIUM (DEL2 FORMULATION), MANUFACTURED IN STAFFORD SPRINGS, CT CEFOXITIN SODIUM (STERILE BULK), MANUFACTURED IN MILANO, ITALY WARFARIN SODIUM, MANUFACTURED IN GUJARAT, INDIA MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN JENA, GERMANY MANUFACTURING METHODS OF AMPULES AND SYRINGES, MANUFACTURED IN OSAKA, JAPAN URAVAR FB209 BT-57, MANUFACTURED BY SCHENECTADY EUROPE S.A. IN BETHUNE CEDEX, FRANCE MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN IBARAKI, JAPAN SODIUM PYRUVATE, MANUFACTURED IN IBARAKI, JAPAN POLY(D,L-LACTIDE) AND ITS COPOLYMERS, MANUFACTURED IN INGELHEIM/RHEIN, FEDERAL REPUBLIC OF GERMANY 11151-T WHITE PE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA AND BELGIUM, FEDERAL REPUBLIC OF GERMANY

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4Q2012EXCEL DMF# 12985 I 12986 I 12987 I 12988 A 12989 12990 A 12991 I 12992 12993 I 12994 12995 I 12996 I 12997 12998 I 12999 13000 A 13001 I 13002 13003 A 13004 A 13005 13006 13007 13008 I 13009 13010 13011 13012 13013 A A I A I II II II II II 5/25/1998 6/1/1998 5/26/1998 5/28/1998 6/5/1998 SANDOZ GMBH ERREGIERRE SPA FUJISAWA PHARMACEUTICAL CO LTD QUIMICA SINTETICA SA FARMABIOS SRL I A I II II II II 5/28/1998 5/28/1998 5/28/1998 5/29/1998 II 5/27/1998 I II II 5/26/1998 5/26/1998 JOHNSON MATTHEY INC BORREGAARD AS, BORREGAARD SYNTHESIS DYNAMIT NOBEL GMBH EXPLOSIVSTOFF UND SYSTEMECHNIK NEW CONCEPT THERAPEUTICS INC RELIABLE BIOPHARMACEUTICAL CORP NEW CONCEPT THERAPEUTICS INC PHARMACIA AND UPJOHN SPA II 5/19/1998 LIPOID GMBH A II IV 5/21/1998 5/19/1998 COSMA SPA LIPOID GMBH OXAPROZIN, MANUFACTURED IN BERGAMO, ITALY LIPOID PC 16:0/16:0 (1.2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO CHOLINE), MANUFACTURED IN LUDWIGSHAFEN, GERMANY LIPOID PC 16:0/16:0 (1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO CHOLINE), MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY AMD 3100, MANUFACTURED IN WEST DEPTFORD, NEW JERSEY BFI BULK INTERMEDIATE, MANUFACTURED IN SARPSBORG, NORWAY SR 47436 (CRUDE) MANUFACTURED IN LEVERKUSEN, GERMANY 10B-ENRICHED L-P-BORONOPHENYLALANINE, MANUFACTUREDIN CARY, NC CLADRIBINE, MANUFACTURED IN ST. LOUIS, MISSOURI 10B ENRICHED P-BORONOPHENYLALANINE, MANUFACTURED IN CARY, NC A II II 5/21/1998 5/22/1998 I 5/19/1998 SHANGHAI SHEN XING PHARMACEUTICAL FACTORY IDT AUSTRALIA LTD CHEMI SPA I II II 5/18/1998 5/15/1998 HUBEI PHARMACEUTICAL FACTORY BACHEM AG A II III 5/15/1998 4/30/1998 ISOCHEM SAS KUTTERER MAUER AG II 5/18/1998 A II II 5/15/1998 5/5/1998 II 5/15/1998 SUZHOU NUMBER 4 PHARMACUTICAL FACTORY SIEGFRIED USA LLC PRIME EUROPEAN THERAPEUTICS SPA EUTICALS SPA SANOFI SYNTHELABO INC. II 5/11/1998 LONZA LTD II 5/11/1998 STATUS Type SUBMIT DATE II 5/7/1998 HOLDER SUBJECT CHINA CHEMICAL SYNTHESIS INDUSTRIAL CHLORAMPHENICAL USP XXIII. MANUFACTURED IN TAIWAN, CHINA CO LTD ZHEJIANG HISUN PHARMACEUTICAL CO LTD CLONAZEPAM, USP, MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA

4Q2012

2-BUTYL-3-H-IMIDAZOL-4-CARBALDEHYDE (IMALOC SB 202783), MANUFACTURED IN VISP, SWITZERLAND CLINDAMYCIN ISOPROPYLIDENE, INTERMEDIATE, MANUFACTURED IN JIANGSU PROVINCE, CHINA METHYLPHENIDATE HCI, MANUFACTURED IN PENNSVILLE, NJ 31/AC HCI, MANUFACTURED IN ORIGGIO, ITALY SUCCIMER (MESO-2,3-DIMERCAPTOSUCCINIC ACID), MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND AMINOPYRROLAMIDE, MANUFACTURED IN GENNEVILLIERS AND PITHIVIERS, FRANCE CAPS MADE FROM PLASTIC MATERIAL/RESINS, MANUFACTURED IN KARLSRUHE, GERMANY LEVONORGESTREL, USP, MANUFACTURED IN HUBEI, CHINA PEPTIDE P829 (DEPREOTIDE) TRIFLUOROACETATE, MANUFACTURED IN BUBENDORF, SWITZERLAND MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN SHANGHAI, CHINA ACETAZOLAMIDE, USP, MANUFACTURED IN BORONIA VICTORIA, AUSTRALIA DMPC (DIMYRISTOYL-PHOSPHATIDYLCHOLINE), MANUFACTURED IN FROSINONE, ITALY

9-AMINOCAMPTOTHECIN COLLOIDAL DISPERSION, MANUFACTURED IN NERVIANO-MIITALY CTAZ.DH (=CEFTAZIDIME DIHYDROCHLORIDE), MANUFACTURED IN TYROL, AUSTRIA PROPAFENONE HYDROCHLORIDE USP, MANUFACTURED IN BERGAMO, ITALY FK 960, MANUFACTURED IN OSAKA, JAPAN ITRACONAZOLE, MANUFACTURED IN MADRID, SPAIN BUDESONIDE, MANUFACTURED IN PAVIA, ITALY

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4Q2012EXCEL DMF# 13014 A 13015 13016 13017 I 13018 13019 13020 I 13021 13022 A 13023 I 13024 I 13025 13026 I 13027 13028 13029 I 13030 A 13031 13032 13033 I 13034 13035 I 13036 13037 I 13038 A 13039 13040 A 13041 13042 A A III II 6/10/1998 6/24/1998 A II II 6/22/1998 6/25/1998 III 6/11/1998 A II II 6/17/1998 6/15/1998 I II II 6/16/1998 6/17/1998 CUNO INC JIN ZHOU FIRST PHARMACEUTICAL FACTORY QUIMICA SINTETICA SA ZETAPOR 020ST, MANUFACTURED IN MERIDEN, CT PARACETAMOL, MANUFACTURED IN JINZOU, CHINA FAMOTIDINE, MANUFACTURED IN MADRID, SPAIN I A IV II III 6/17/1998 6/18/1998 6/17/1998 BORCULO WHEY PRODUCTS R AND D MSD INTERNATIONAL GMBH HELVOET PHARMA MARYLAND II 6/18/1998 KISSEI PHARMACEUTICAL CO LTD I I II III II 6/17/1998 6/15/1998 6/15/1998 I II II 6/17/1998 6/16/1998 II 6/12/1998 II 6/12/1998 WUJING CHANGXIN BIOCHEMISTRY FACTORY NANJING CHENGHONG BIOCHEMICAL FACTORY GEDEON RICHTER PLC A II II 6/15/1998 6/11/1998 TARO PHARMACEUTICAL INDUSTRIES LTD SAFC BIOSCIENCES INC A A II II III 6/10/1998 6/12/1998 6/11/1998 ZACH SYSTEM SPA EUTICALS SPA AMPACET CORP SULINDAC SULFONE, MANUFACTURED IN VICENZA, ITALY MECAMYLAMINE BASE, MANUFACTURED IN ROZZANO-(MI), ITALY I I II II II 6/10/1998 6/11/1998 6/11/1998 MCNEIL CONSUMER HEALTHCARE CSF BIOTECH NEXTRAN INC STATUS Type SUBMIT DATE III 6/2/1998 HOLDER SARTORIUS STEDIM BIOTECH SA SUBJECT

4Q2012

STEDIM 71 BAGS FOR HUMAN DRUGS AND BIOLOGICS PACKAGING, MANUFACTURED IN AUBAGNE CEDEX, FRANCE NICOTINE PURIFICATION PROCESS, MANUFACTURED IN CORK, IRELAND PACLITAXEL, MANUFACTURED IN SAINTE-FOY, CANADA AND CORK, IRELAND TRISACCHARIDE FREE ACID (TRFA), MANUFACTURED IN LA JOLLA AND SAN DIEGO, CA

110849 WHITE HD POLYETHYLENE MASTERBATCH, MANUFACTURED INTERRE HAUTE, IN, CARTERSVILLE, GA AND DERIDDER, LA CLOMIPRAMINE HYDROCHLORIDE, MANUFACTURED IN HAIFA BAY, ISRAEL EX-CELL 301 COMPLETE MEDIUM (MODIFIED), MANUFACTURED IN DENVER, PENNSYVANIA HUMAN MENOPAUSAL GONADOTROPIN, MANUFACTURED IN CHANGZHOU, CHINA HUMAN CHORIONIC GONADOTROPIN, MANUFACTURED IN JIANGSU, CHINA 17-DEACETYL NORGESTIMATE, MANUFACTURED IN BUDAPEST, HUNGARY

BASF PHARMACHEMIKALIEN GMBH AND CO FLUOXETINE HYDROCHLORIDE, MANUFACTURED IN MINDEN, GERMANY KG TACONIC BIOTECHNOLOGY ANTIBODY RELATED REAGENTS, MANUFACTURED IN RENNSELAER, N.Y. TENNECO PACKAGING FILMS LTD AUSIMONT USA INC MONO PVC FILMS, MANUFACTURED IN SOUTH WALES, GREAT BRITAIN POLYMIST F5A TSP, MANUFACTURED IN ORANGE, TX; BELLE MEAD & CRANBURY, NJ (TOLL PROCESSORS) KMD-3213 DRUG SUBSTANCE, MANUFACTURED IN SAN LUIS OBISPO, CALIFORNIA FOR KISSEI PHARMACEUTICAL CO LTD LACTOCHEM, MANUFACTURED IN AB BORCULO, THE NETHERLANDS LORATADINE, MANUFACTURED IN SINGAPORE RUBBER CLOSURE FORMULATION B5001-BLUE 3XD, MANUFACTURED IN SALISBURY, MD

SHANGHAI TONGREN PHARMACEUTICAL CO IVERMECTIN, MANUFACTURED IN SHANGHAI, PEOPLES REPUBLIC OF CHINA LTD BASELL POLIOLEFINE ITALIA SRL POLYPROPYLENES HOMOPOLYMERS, COPOLYMERS AND TERPOLYMERS, MANUFACTURED IN FERRARA, BRINDISI AND TERNI, ITALY, WESSELING, GERMANY, ROTTERDAM, NETHERLANDS AND MANCHESTER, UNITED KINGDOM APOTEX PHARMACHEM INC DOXAZOSIN MESYLATE, MANUFACTURED IN ONTARIO, CANADA KUNSHAN ORIENTAL PHARMACEUTICAL CO DOXYCYCLINE USP, NON-STERILE BULK DRUG AS MANUFACTURED IN JIANGSU LTD PROVINCE, CHINA POLIMERI EUROPA SPA FLEXIRENE CM50, MANUFACTURED IN DUNKIRK, FRANCE JOHNSON MATTHEY PHARMACEUTICAL MATERIALS 1-(MERCAPTOMETHYL)CYCLOPROPYL ACETIC ACID (TAD), MANUFACTURED IN CONSHOHOCKEN, PA Page

381

4Q2012EXCEL DMF# 13043 I 13044 A 13045 13046 I 13047 13048 13049 I 13050 I 13051 13052 I 13053 13054 13055 13056 I 13057 I 13058 A 13059 I 13060 I 13061 A 13062 13063 A 13064 A 13065 A 13066 A 13067 A 13068 I II 6/26/1998 IV 7/7/1998 III 7/9/1998 IV 7/15/1998 III 6/26/1998 I III IV 3/24/1998 7/7/1998 POLIMERI EUROPA FRANCE SA BAYER PHARMA AG II 7/7/1998 BAYER PHARMA AG II 7/7/1998 CATALENT FRANCE BEINHEIM S.A V 6/23/1998 II 7/6/1998 TAKASAGO INTERNATIONAL CORP I 7/6/1998 TAKASAGO INTERNATIONAL CORP I I A II III II IV 7/2/1998 7/2/1998 6/29/1998 7/7/1998 H. LUNDBECK A/S INGE SPA MEDICHEM SA MITSUBISHI CHEMICAL CORP I III II 7/2/1998 7/2/1998 II 7/2/1998 I A II III II 6/28/1998 6/29/1998 6/30/1998 ALDRICH CHEMICAL CO INC INEOS ABS USA CORP AVECIA BIOTECHNOLOGY, INC. A II III 6/26/1998 7/28/1998 V 6/24/1998 CATALYTICA PHARMACEUTICALS INC DBA DSM CATALYTICA PHARMACEUTICAL DIPHARMA FRANCIS SRL TARGOR UK LIMITED SPECIALITIES STATUS Type SUBMIT DATE III 6/22/1998 HOLDER SHELL CHEMICAL CO SUBJECT

4Q2012

SOLID EPOXY RESINS, MANUFACTURED IN WESSELING, GERMANY AND DEER PARK, TEXAS STERILE PRODUCT OPERATION-SOUTH(SPO-SOUTH) IN GREENVILLE NORTH CAROLINA DICLOFENAC POTASSIUM, MANUFACTURED IN MILAN, ITALY HOSTACOM D1124 NATURAL 001, MANUFACTURED IN MIDDLESBROUGH, UNITED KINGDOM RHODAMINE 123, MANUFACTURED IN SHEBOYGEN FALLS, WI LUSTRAN ABS 348-VARIOUS, MANUFACTURED IN ADDYSTON, OH

OLIGONUCLEOTIDE 2006 ACTIVE PHARMACEUTICAL INGREDIENT, MANUFACTURED IN MILFORD, MASSACHUSETTS LIANYUNGANG PHARMACEUTICAL FACTORY CYCLOPHOSPHAMIDE USP,NON-STERILE BULK DRUG, MANUFACTURED IN JIANGSU PROVINCE, PEOPLE'S REPUBLIC OF CHINA ISHIDA PRESS KOGYO CO LTD ALUMINUM CAPS FOR MEDICAL VIALS, MANUFACTURED IN SAITAMA, JAPAN H. LUNDBECK A/S LU 28-179-C, DRUG SUBSTANCE, MANUFACTURED IN NYKOBING SJ. AND VALBY, DENMARK LU 28-179-CAPSULES, MANUFACTURED IN VALBY, DENMARK PLASTIC PACKAGING, MANUFACTURED IN MILAN, ITALY ENALAPRIL MALEATE, MANUFACTURED IN GERONA, SPAIN SUCROSE FATY ACID ESTERS-SUCROSE STEARIC ACID ESTERS AND SUCROSE PALMITIC ACID ESTERS, MANUFACTURED IN YOKKAICHI, MIE PREFECTURE, JAPAN MANUFACTURING SITE, FACILTIES, PERSONNEL AND OPERATIONAL PROCEDURES IN SHIZUOKA PREFECTURE, JAPAN [2R-[2A,5A,6A(R*)]]-6-(L-HYDROXYETHYL)-3,7-DIOXO-L-AZABICYCLO [3.2.0]HEPTANE-2CARBOXYYLIC ACID, (4-NITROPHENYL) METHYL ESTER, OR TRADE NAME OF ADC-13 OR BICYCLIC KETONE, MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN

EUROPEAN ORGANIZATION FOR RESEARCH PERSONNEL AND PROCEDURES FOR THE DEVELOPMENT OF ANTI-CANCER AGENTS AND TREATMENT OF CANCER (EORTC) AND OTHER MODALITES IN CLINICAL TRIALS IN BRUSSELS, BELGIUM AMPRENAVIR 50 AND 150 MG SOFT GELATIN CAPSULES, MANUFACTURED IN BEINHEIM, FRANCE GADOBUTROL (ESUB) AS MANUFACTURED IN BERLIN AND BERGKAMEN, FEDERAL REPUBLIC OF GERMANY RIBLENE FL24, MANUFACTURED IN DUNKIRK, FRANCE

CALCIUMBUTROL (ESUB) AS MANUFACTURED IN BERLIN, FEDERAL REPUBLIC OF GERMANY FUJIMORI KOGYO CO LTD PLASTIC FILM FOR USE IN DRUG SUBSTANCE AND PRODUCT CONTAINERS, MANUFACTURED IN MIE PREFECTURE, JAPAN MINGTAI CHEMICAL CO LTD COMPRECEL MICROCRYSTALLINE CELLULOSE, TYPES M200D+ M200 & M212 MANUFACTURED IN TAIWAN, R.O.C. PRINTAL OY ONE-PIECE ALUMINIUM CANS, BOTTLES AND RIGID CONTAINERS, MANUFACTURED IN HANKO, FINLAND MEXICHEM UK LTD INHALATION GRADE 1,1,1,2-TETRAFLUOROETHANE, MANUFACTURED IN RUNCORN CHESHIRE, UNITED KINGDOM LANZHOU CHEMISTRY NATRUAL PRODUCTS 4'-DEMETHYL-EPIPODOPHYLLOTOXIN, MANUFACTURED IN GANSU PROVINCE, CHINA FACTORY Page 382

4Q2012EXCEL DMF# 13069 13070 13071 I 13072 13073 A 13074 13075 A 13076 13077 13078 13079 A 13080 A 13081 13082 A 13083 13084 13085 13086 13087 A 13088 13089 13090 13091 A 13092 A 13093 13094 13095 I 13096 A 13097 I 13098 I II 7/24/1998 III 7/27/1998 III 7/22/1998 INEOS ABS USA CORP I I II II III 7/27/1998 7/28/1998 7/22/1998 II 7/10/1998 I I A III II II IV 7/22/1998 7/21/1998 7/27/1998 7/23/1998 WADDINGTON JAYCARE LTD DIPHARMA SPA PURESYN INC I A I A II II II II II 7/21/1998 7/22/1998 7/20/1998 7/21/1998 7/24/1998 I IV II 7/21/1998 7/8/1998 II 7/17/1998 CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD CERESTAR USA INC ZHEJIANG CANDORLY PHARMACEUTICAL CO LTD ERREGIERRE SPA PCAS CUNO INC ERCROS SA CHEMWERTH INC A I I III III III III 7/20/1998 7/10/1998 7/10/1998 7/15/1998 BORMIOLI ROCCO SPA BU PLASTICS POLIMERI EUROPA FRANCE SA POLIMERI EUROPA FRANCE SA ILC DOVER INC A II III 7/17/1998 7/16/1998 A II II 7/13/1998 7/7/1998 RANBAXY LABORATORIES LTD SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTD ISHIHARA SANGYO KAISHA LTD INTRAPAC CORP STATUS Type SUBMIT DATE A I II II II 7/9/1998 7/15/1998 7/1/1998 HOLDER DR REDDYS LABORATORIES LTD MITSUBISHI TANABE PHARMA CORP BASF AKTIENGESELLSCHAFT SUBJECT

4Q2012

FLUOXETINE HYDROCHLORIDE, USP, MANUFACTURED IN ANDHRA PRADESH, INDIA MCC-135 (BULK DRUG SUBSTANCE), MANUFACTURED IN IBARAKI-KEN, JAPAN 9-Z-ISOTRETINOIN, MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY CIPROFLOXACIN HYDROCHLORIDE, MANUFACTURED IN MADHYA PRADESH, INDIA SULFADIMETHOXINE (PHARMACEUTICAL RAW MATERIAL), MANUFACTURED IN SHANGHAI, CHINA CEVIMELINE HYDROCHLORIDE, MANUFACTURED IN YOKKAICHI, MIE, JAPAN METERED DOSE INHALER CANS INTERNALLY COATED WITH FLUOROPOLYMER, MANUFACTURED IN HARRISONBURG, VIRGINIA HDPE BOTTLE 40 ML, MANUFACTURED IN CASTALGUELFO (PR) ITALY ERACLENE MM 74, MANUFACTURED IN MILANO-ITALY RIBLENE FC 40, MANUFACTURED IN MILANO-ITALY FLEIBLE CONTAINMENT DEVICE USED TO STORE ACTIVE PHARMACEUTICAL INGREDIENTS (BULK DRUG SUBSTANCE), MANUFACTURED IN FREDERICA, DE METHOCARBAMOL USP (BULK ACTIVE PHARMACEUTICAL INGREDIENT), MANUFACTURED IN TAIWAN, THE R.O.C. HYDROXYPROPYL BETA CYCLODEXTRIN, MANUFACTURED IN WAUKEGAN, IL CLINDAMYCIN PHOSPHATE U.S.P., MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF CHINA SOTALOL HYDROCHLORIDE, MANUFACTURED IN BERGAMO, ITALY OXYBUTYNIN BASE, MANUFACTURED IN LIMAY, FRANCE ZETA PLUS DELIPID PLUS, MANUFACTURED IN STAFFORD SPRINGS, CT FAMOTIDINE, MANUFACTURED IN MADRID, SPAIN AMRINONE USP, NON-STERILE BULK DRUG INTENDED FOR HUMAN USE MANUFACTURED IN ZHEJIANG PROVINCE, CHINA FOR CHEMWERTH INC 500ML/750ML ROUND HDPE BOTTLE, MANUFACTURED IN LONDON, ENGLAND SULINDAC, MANFACTURED IN MERETO DI TOMBA (UD), ITALY POLYFLO RESIN, MANUFACTURED IN MALVERN, PA

CLARIANT PRODUKTE DEUTSCHLAND GMBH MACROGOLS (INN)=POLYETHYLENE GLYCOLS (NF), MANUFACTURED IN BURGKIRCHEN, GERMANY SHANDONG XINHUA PHARMACEUTICAL CO CAFFEINE ANHYDROUS, MANUFACTURED IN SHANDONG, CHINA LTD NV ORGANON PORCINE INSULIN HIGHLY PURIFIED, MANUFACTURED IN SERFONTAINE, FRANCE DIOSYNTH BV INEOS ABS USA CORP ORG 9487, MANUFACTURED IN BH OSS, THE NETHERLANDS LUSTRAN SAN 32 20010, LUSTRAN SAN 29 20029, MANUFACTURED IN ADDYSTON, OH LUSTRAN SAN 29-2040 LUB TINTED, LUSTRAN SAN 31-2060 LUB CRYSTAL, LUSTRAN SAN 31-1000 LUB NATURAL, LUSTRAN SAN SPARKLE 2090 UNL CRYSTAL, LUSTRAN SAN SPARKLE 2090 LUB CRYSTAL, MANUFACTURED IN ADDYSTON, OH

PHARMACEUTICAL AND MEDICAL PLASTICS HIGH DENSITY POLYETHLENE RESIN (165770), MANUFACTURED IN VICKSBURG, MI INC SF-CHEM Y 2-BROMO-4'-(METHLSULFONYL) ACETOPHENONE, (BROMOSULFONE), MANUFACTURED IN PRATELN, SWITZERLAND

Page 383

4Q2012EXCEL DMF# 13099 I 13100 I 13101 13102 13103 I 13104 I 13105 I 13106 13107 13108 A 13109 I 13110 13111 I 13112 13113 13114 I 13115 I 13116 A 13117 I 13118 I 13119 I 13120 I 13121 I 13122 13123 I 13124 13125 13126 I I I II II II 7/27/1998 8/11/1998 8/11/1998 JINZHOU JIUTAI PHARMACEUTICAL CO LTD TEVA GROUP LIPOMED AG I IV IV 8/11/1998 8/11/1998 FONA INTERNATIONAL INC FONA INTERNATIONAL INC IV 8/11/1998 FONA INTERNATIONAL INC IV 8/11/1998 II 8/11/1998 CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTD FONA INTERNATIONAL INC III 8/6/1998 INGENIA POLYMERS CORP III 8/6/1998 III 8/3/1998 II 8/7/1998 CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTD ISO GESELLSCHAFT FUR ARZNEIVERPACKUNGEN MBH WEDTECH INC A I II II II 8/5/1998 8/4/1998 8/6/1998 KYOWA HAKKO KIRIN CO LTD APTE AMALGAMATIONS LTD LEK PHARMACEUTICALS DD I III II 8/3/1998 8/5/1998 BASELL POLIOLEFINE ITALIA SPA AVANTI POLAR LIPIDS INC III 8/3/1998 I A II II II 7/6/1998 8/5/1998 8/3/1998 II 7/30/1998 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA QUIMICA SINTETICA SA BIOIBERICA SA NIPPON SYNTHETIC CHEMICAL INDUSTRY CO LTD LOPAREX BV II 7/31/1998 A A II IV II 7/30/1998 7/29/1998 7/26/1998 AMSA SPA DMV FONTERRA EXCIPIENTS GMBH CO KG CHAICHEM PHARMACEUTICALS INTERNATIONAL CHEMI SPA II 7/30/1998 BIONEBRASKA INC RECOMBINANT HUMAN GROWTH HORMONE RELEASING FACTOR (RGRF), MANUFACTURED IN LINCOLN, NEBRASKA GLIPIZIDE (ESUB) MANUFACTURED IN COMO, ITALY HMS LACTOSE DT PACITAXELINE, MANUFACTURED IN QUEBEC, CANADA STATUS Type SUBMIT DATE II 7/31/1998 HOLDER RANBAXY LABORATORIES LTD SUBJECT

4Q2012

7-AMINO-3-CHLORO-3-CEPHEM-4-CARBOXYLIC ACID, MANUFACTURED IN PUNJAB, INDIA

DMPG. NA (DIMYRISTOYL-PHOSPHATIDYLGLYCEROL), MANUFACTURED IN FROSINONE, ITALY NABUMETONE, MANUFACTURED IN LATINA, ITLAY BUTOCONAZOLE NITRATE, MANUFACTURED IN MADRID, SPAIN CHONDROITIN SULFATE, MANUFACTURED IN BARCELONA, SPAIN 'TBHI', MANUFACTURED IN KUMAMOTO, JAPAN FL20000 100 MICRON PET EASY/EASY PRODUCT CODE 78-100-A-320-B OR 7CF MANUFACTURED IN APELDOORN THE NETHERLANDS LUPOLEN 2420 K, MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY 1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE-N-GLUTARYL, MANUFACTURED IN ALABASTER, AL KRN5500 DRUG SUBSTANCE, MANUFACTURED IN TAKASKI-SHI GUNMA, JAPAN SULFAMETHOXAZOLE, MANUFACTURED IN MAHARASHTRA STATE INDIA ENALAPRIL MALEATE, ACTIVE SUBSTANCE, MANUFACTURED IN KOLODVORSKA, SLOVENIA NIFEDIPINE USP, (BULK ACTIVE PHARMACEUTICAL INGREDIENT), MANFACTURED IN TAIWAN, THE REPUBLIC OF CHINA PACKAGING MATERIAL, MANUFACTURED IN BAD KONIGSHOFEN, GERMANY WEDTECH 1005 WHITE FOR USE IN PACKAGING MATERIALS, MANUFACTURED IN ALBERTA & ONTARIO, CANADA WEDTECH WT-157 WHITE FOR USE IN PACKAGING MATERIALS, MANUFACTURED IN ALBERTA & ONTARIO, CANADA OXAPROZIN (BULK ACTIVE PHARMACEUTICAL INGREDIENT), MANUFACTURED IN TAIWAN, THE REPUBLIC OF CHINA 840.042 NATURAL FLAVOR (CREAM TYPE), MANUFACTURED IN CAROL STREAM, ILLINOIS 884.114 N-C NATURAL & ARTIFICIAL ORANGE FLAVOR, MANUFACTURED IN CAROL STREAM, ILLINOIS 877.038 N-C NATURAL MINT FLAVOR, MANUFACTURED IN CAROL STREAM, ILLINOIS 894.037 N-C NATURAL PEPPERMINT FLAVOR, MANUFACTURED IN CAROL STREAM, ILLINOIS CHLORHEXIDINE ACETATE, MANUFACTURED IN JINZHOU, CHINA CARBAMAZEPINE USP, MANUFACTURED IN NETANYA, ISRAEL AG14-35 (VICUREX), MANUFACTURED IN ARLESHEIM, SWITZERLAND

Page 384

4Q2012EXCEL DMF# 13127 13128 13129 A 13130 13131 13132 13133 I 13134 13135 I 13136 13137 13138 I 13139 I 13140 I 13141 13142 I 13143 I 13144 A 13145 13146 13147 13148 I 13149 13150 13151 I 13152 13153 A 13154 I 13155 I II 8/26/1998 REPLIGEN CORP III 8/26/1998 POLYTECH KUNSTSTOFF GMBH A II III 8/25/1998 8/21/1998 A A IV II II 8/25/1998 8/21/1998 8/24/1998 I I I II II II II 8/20/1998 8/18/1998 8/18/1998 8/21/1998 II 8/18/1998 III 7/13/1998 MUNNERSTADTER GLASWARENFABRIK GMBH SHANDONG XINHUA PHARMACEUTICAL CO LTD PFANSTIEHL LABORATORIES INC NEOMPS INC MULTIPLE PEPTIDE SYSTEMS CHONGQING UNIT MODERN TECHNOLOGY CO LTD ROTEM AMFERT NEGEV LTD POLYPEPTIDE LABORATORIES INC VALEANT PHARMACEUTICALS NORTH AMERICA ISO TEX DIAGNOSTICS INC REXAM HEALTHCARE LE TREPORT SAS I II II 8/18/1998 8/18/1998 DEGUSSA AG WERK RADEBEUL ASH STEVENS INC III 8/14/1998 B BRAUN MEDICAL INC III 8/6/1998 INGENIA POLYMERS CORP I I V II III 10/9/1998 8/7/1998 8/6/1998 A V II 8/17/1998 8/14/1998 FRESENIUS KABI NORGE AS I I A II III II II 8/12/1998 8/7/1998 8/12/1998 8/14/1998 NATCO PHARMA LTD CHEMICAL DIV ARTSANA SPA MALLINCKRODT INC ELAN DRUG DELIVERY INC STATUS Type SUBMIT DATE A I II V IV 8/12/1998 8/12/1998 8/13/1998 HOLDER EVONIK TECHNOCHEMIE GMBH ASTA MEDICA INC SANWA STARCH CO LTD SUBJECT CLOMIPRAMINE HYDROCHLORIDE, MANUFACTURED IN HANAU, GERMANY TOXICOLOGY INFORMATION FOR PERIFOSINE (D-21266)

4Q2012

CRYSTALLINE MALTOSE, MANUFACTURED IN KASHIHARA CITY, NARA PREFECTURE, JAPAN DILTIAZEM HYDROCHLORIDE, USP, MANUFACTURED IN ANDHRA PRADESH, INDIA PACKAGING MATERIAL, MANUFACTURED IN COMO, ITALY METHYLPHENIDATE BASE (ESUB) MANUFACTURED IN ST. LOUIS, MISSOURI RITALIN QD (METHYLPHENIDATE) ONCE DAILY CAPSULES, MANUFACTURED IN IN GAINSVILLE, GA (PRIMARY) AND ATHLONE, COUNTY WESTMEATH, IRELAND (ALTERNATE) STERILE MANUFACTURING OPERATIONS IN HALDON, NORWAY

INSTITUTE DRUG TECHNOLOGY AUSTRALIA LOXAPINE BASE, MANUFACTURED IN BORONIA VICTORIA, AUSTRALIA LTD PHARMACIA AND UPJOHN INC TOXICOLOGY INFORMATION FOR IODODOXORUBICIN HCL ENDURA SPA INGENIA POLYMERS CORP PIPERONYL BUTOXIDE, MANUFACTURED IN BOLOGNA, ITALY WT-152 WHITE (WHITE COLOUR CONCENTRATE), MANUFACTURED IN ALBERTA AND ONTARIO, CANADA WT-153 WHITE (WHITE COLOUR CONCENTRATE), MANUFACTURED IN ALBERTA AND ONTARIO, CANADA 250 ML STERILE FLEXIBLE I.V. CONTAINER, PART NUMBER 80-203, MANUFACTURED IN IRVINE, CA KETAMINE HYDROCHLORIDE, MANUFACTURED IN RADEUL, GERMANY N-(2-PYRAZINECARBONYL)-L-PHENYLALANINE-L-LEUCINE BORONIC ACID BULK DRUG SUBSTANCE, MANUFACTURED IN RIVERVIEW, MI ARTICLES OF TUBULAR GLASS USED AS CONTAINERS, MANUFACTURED IN BAD BOCKLET-HOHN, FEDERAL REPUBLIC OF GERMANY TRIMETHOPRIM USP, MANUFACTURED IN ZIBO, SHANDONG, PEOPLE'S REPUBLIC OF CHINA D-GLUCOSAMINE HYDROCHLORIDE, HIGH PURITY, MANUFACTURED IN WAUKEGAN, IL MBI 226, A SYNTHETIC PEPTIDE, MANUFACTURED IN SAN DIEGO, CA MPS-35, A SYNTHETIC PEPTIDE, MANUFACTURED IN SAN DIEGO, CA PACLITAXEL, MANUFACTURED IN NANQIAOSI, DASHIBA, JIANGBEI DISTRICT, CHONGQUING, P.R. CHINA EXCIPIENT, WHITE PHOSPHORIC ACID, MANUFACTURED IN M.P. ARAVA, ISRAEL LEUPROLIDE, MANUFACTURED IN TORRANCE, CA MOGADON (NITRAZEPAM) TABLETS, MANUFACTURED IN BASEL, SWITZERLAND INDIUM-111, MANUFACTURED IN FRIENDSWOOD, TEXAS PACKAGING MATERIALS, PHARMACEUTICALS SPRAY PUMPS, MANUFACTURED IN LE TREPORT, FRANCE PACKAGING MATERIALS FOR HDPE BOTTLE 950 ML, MANUFACTURED IN TETTAUKLEINTETTAU, GERMANY IMMOBLIZED (R) PROTEIN (A) TM, IPA-500, MANUFACTURED IN NEEDHAM, MASSACHUSETTS

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4Q2012EXCEL DMF# 13156 A 13157 13158 I 13159 13160 13161 13162 13163 A 13164 13165 I 13166 13167 13168 A 13169 13170 13171 I 13172 A 13173 13174 13175 13176 13177 I 13178 13179 I 13180 13181 A 13182 13183 13184 I 13185 13186 13187 13188 A I I A II II III II 9/14/1998 9/14/1998 9/15/1998 9/11/1998 VIRCHOW LABORATORIES LTD HEUMANN PHARMA GMBH GRAHAM PACKAGING CO LP MACFARLAN SMITH LTD I I II II 9/17/1998 9/10/1998 9/14/1998 DAIICHI PHARMACEUTICAL CO LTD YANGZHOU PHARMACEUTICAL FACTORY VIRCHOW LABORATORIES LIMITED I II II 9/9/1998 9/10/1998 PROMETIC BIOSCIENCES LTD ST PHARM CO LTD DECYL AGAROSE 6XL, MANUFACTURED IN ISLE OF MAN, GREAT BRITAIN I II II 9/4/1998 9/8/1998 C A I I II II IV IV I 8/6/1998 9/10/1998 8/25/1998 7/30/1998 9/10/1998 CRYSTAL PHARMA SAU YANGZHOU PHARMACEUTICAL CO LTD FONA INTERNATIONAL INC MASTERTASTE INC ADVANCED SYTHESIS TECHNOLOGIES SADE CV MEDICHEM SA II 9/4/1998 AVANTI POLAR LIPIDS INC A A II III III 9/1/1998 8/27/1998 9/4/1998 AEROJET FINE CHEMICALS LLC ALBIS PLASTIC GMBH ABBOTT LABORATORIES A A II III III 9/2/1998 8/31/1998 9/2/1998 APOTEX PHARMACHEM INC LAGEEN TUBOBLAST LTD SARTORIUS STEDIM BIOTECH SA A III I 9/1/1998 9/2/1998 BOXMORE PLASTICS LTD APTE AMALGAMATIONS LTD I A I A III II II IV IV 8/28/1998 8/27/1998 8/26/1998 9/1/1998 8/31/1998 SABIC PETROCHEMICALS BV ISO TEX DIAGNOSTICS INC SIEGFRIED CHEMICALS INC SIGMA ALDRICH MANUFACTURING LLC LIPOID GMBH I II I 8/27/1998 6/23/1998 AMYLIN PHARMACEUTICALS INC AJINOMOTO CO INC STATUS Type SUBMIT DATE IV 8/15/1998 HOLDER MINGTAI CHEMICAL CO LTD SUBJECT

4Q2012

COMPRECEL MICROCRYSTALLINE CELLULOSE, TYPES M301D+ M302D+M301 & M302, AS MANUFACTURED IN TAIWAN, ROC EXENDIN-4 INJECTION DRUG PRODUCT, MANUFACTURED IN SAN DIEGO, CA MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN YOKKAICHI, MIE PREFECTURE, JAPAN SABIC LDPE 2101TN47 POLYETHYLENE, MANUFACTURED IN BEEK, THE NETHERLANDS PLATINUM-195M (PT-195M), MANUFACTURED IN FRIENDSWOOD, TEXAS VALPROIC ACID, MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA L-A-PHOSPHATIDYLCHOLINE DIPALMITOYL, MANUFACTURED IN ST. LOUIS, MO LIPOID PA 16:0/16:0 (1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHATIDIC ACID MONOSODIUM SALT), MANUFACTURED IN LUDWIGSHAFEN, GERMANY PLASTIC CONTAINERS, MANUFACTURED IN COUNTY CAVAN, IRELAND MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN MAHARASHTRA STATE INDIA TERAZOSIN HCI DIHYDRATE, MANUFACTURED IN ONTARIO, CANADA ALUMINUM TUBES AND CAPS, MANUFACTURED IN HOLON, ISRAEL STEDIM 40 BAGS FOR HUMAN DRUGS AND BIOLOGICS, MANUFACTURED IN AUBAGNE CEDEX, FRANCE CARMUSTINE (BCNU), MANUFACTURED IN RANCHO CORDOVA, CA LUPOLEN 1840 H WHITE 99950, MANUFACTURED IN HAMBURG, GERMANY FORM FILL SEAL FLEXIBLE CONTAINER, MANUFACTURED IN ROCKY MOUNTAIN, NORTH CAROLINA 1,2-DIOLEOYL-SN-GLYCERO-3-[PHOSPHO-RAC-(1-GLYCEROL)](DOPG), MANUFACTURED IN ALABASTER, AL PREDNISONE ANHYDROUS USP, MANUFACTURED IN BOECILLO (VALLADOLID), SPAIN DOXYCYCLINE HYCLATE, MANUFACTURED IN JIANGSU PROVINCE, CHINA #862.378 LEMON FLAVOR, NATURAL (WONF), MANUFACTURED IN CAROL STREAM, IL NA & ART VANILLA FLAVOR 601444, MANUFACTURED IN TETERBORO, NEW JERSEY MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN TIJUANA, MEXICO GABAPENTIN, DRUG SUBSTANCE, MANUFACTURED IN CELRA (GERONA), SPAIN

YAMAMOTO CHEMICAL INDUSTRIES CO LTD FLAVOXATE HYDROCHLORIDE JP XIII, MANUFACTURED IN WAKAYAMA CITY, JAPAN

ZIDOVUDINE DRUG SUBSTANCE, MANUFACTURED IN SHIHEUNG-SHI KYUNGGI-DO, KOREA DX-9065A, MANUFACTURED IN TOKYO, JAPAN METHACYCLINE, MANUFACTURED IN JIANGSU PROVINCE, CHINA MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN HYDERBAD, INDIA SULPHAMETHOXAZOLE-USP, MANUFACTURED IN HYDERABAD, INDIA SOTALOL HYDROCHLORIDE, MANUFACTURED IN FEUCHT, GERMANY PLASTIC CONTAINERS, MANUFACTURED IN CHICAGO, IL APOMORPHINE HYDROCHLORIDE, MANUFACTURED IN EDINBURGH, SCOTLAND Page

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4Q2012EXCEL DMF# 13189 A 13190 13191 I 13192 13193 13194 I 13195 A 13196 13197 13198 13199 13200 I 13201 13202 13203 13204 13205 13206 13207 C 13208 13209 13210 13211 13212 13213 I 13214 13215 13216 13217 13218 13219 A 13220 13221 13222 13223 I I A I II II II II 4/30/1998 4/30/1998 4/30/1998 4/30/1998 HIKMACHEM CONSOLIDATED PHARM SPIC LEK PHARM A I A A I II II II II II II 4/30/1998 4/30/1998 4/30/1998 4/30/1998 4/30/1998 4/30/1998 A A A A A II II II II II II 4/30/1998 4/30/1998 4/30/1998 4/30/1998 4/30/1998 4/30/1998 I I I I A A II II II II II II II 4/30/1998 4/30/1998 4/30/1998 4/30/1998 4/30/1998 4/30/1998 4/30/1998 A A I I V II II II II 9/21/1998 4/30/1998 4/30/1998 4/30/1998 4/30/1998 STERIS ISOMEDIX SERVICES ABBVIE INC GIST BROCADES CULTOR FOOD SCI COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARL SMITHKLINE BEECHAM HOUBA INC BIOCHEMIE DEUTSCHLAND GMBH LILLY RES LABS ACS DOBFAR SPA ACS DOBFAR SPA SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE ACS DOBFAR SPA MEIJI SEIKA PHARMA CO LTD DSM ANTI INFECTIVES CHEMFERM SA MICROBIOPHARM JAPAN CO LTD SANDOZ INDUSTRIAL PRODUCTS SA TEVA PHARMACEUTICALS USA, INC. API DIVISION LUPIN LTD SINTESIS QUIMICA SANDOZ INDUSTRIAL PRODUCTS SA LUPIN LTD BRISTOL MYERS SQUIBB COMPANY LUPIN LTD II 9/23/1998 A I II II II 9/21/1998 9/22/1998 9/23/1998 I IV II 8/25/1998 9/18/1998 ROTEM AMFERT NEGEV LTD STATUS Type SUBMIT DATE II 9/8/1998 HOLDER CORDEN PHARMA SWITZERLAND LLC SUBJECT

4Q2012

1,2-DIPALMITOYL-SN-GLYCERO-3-PHOPHAIDIC ACID SODIUM SALT (DPPA,NA), MANUFACTURED IN LIESTAL, SWITZERLAND MONOBASIC POTASSIUM PHOSPHATE, MANUFACTURED IN M.P. ARAVA, ISRAEL

NIPPON SYNTHETIC CHEMICAL INDUSTRIES 2-N-BUTYL-1H-IMIDAZOLE-4-CARBOXALDEHYDE (BFI), MANUFACTURED IN KUMAMOTO, JAPAN SHASUN PHARMACEUTICALS LTD NIZATIDINE, MANUFACTURED IN CUDDALORE, INDIA ARCHIMICA SPA TEVA PHARMACEUTICAL FINE CHEMICALS SRL CHEMWERTH INC AMRINONE, USP, MANUFACTURED IN ORIGGIO (VA), ITALY TERAZOSIN HCL 2H20, MANUFACTURED IN VARESE, ITALY MILRINONE, NON-STERILE BULK DRUG MANUFACTURED IN ZHEJIANG PROVINCE, CHINA FOR CHEMWERTH INC CONTRACT STERILIZATION FACILITY IN GROVEPORT OHIO ERYTHROMYCIN (ESUB) PENICILLIN G PROCAINE POLYMYXIN B SULFATE OXYTETRACYCLINE AMOXICILLIN TRIHYDRATE DOXYCYCLINE HYCLATE PENICILLIN G PROCAINE STERILE ERYTHROMYCIN ESTOLATE CEFUROXIME SODIUM (STERILE) CEPHALOTHIN SODIUM AMOXICILLIN CEFAZOLIN SODIUM LYOPHILIZED (STERILE BULK) DOXORUBICIN HYDROCHLORIDE CEPHALEXIN MONOHYDRATE AS MANUFACTURED IN BARCELONA, SPAIN DOXORUBICIN HYDROCHLORIDE AMPICILLIN PENICILLIN V POTASSIUM MFG IN MEXICO, MISSOURI RIFAMPIN AMOXICILLIN TRIHYDRATE OXACILLIN SODIUM CEFACLOR (ESUB) CEFACLOR CEFOTAXIME SODIUM USP (STERILE) (ESUB) AS MANUFACTURED IN RAISEN, INDIA CEFADROXIL MONOHYDRATE DICLOXACILLIN SODIUM PENICILLIN G POTASSIUM VANCOMYCIN HYDROCHLORIDE

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4Q2012EXCEL DMF# 13224 13225 13226 13227 13228 13229 I 13230 13231 13232 I 13233 I 13234 13235 13236 I 13237 13238 13239 I 13240 13241 I 13242 I 13243 A 13244 13245 13246 A 13247 A 13248 I 13249 13250 13251 13252 13253 13254 13255 13256 A C A A I I A A II II III III III II II V 9/30/1998 9/29/1998 9/16/1998 9/16/1998 9/16/1998 10/2/1998 10/2/1998 10/1/1998 II 9/30/1998 ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV EVOTEC OAI NEULAND LABORATORIES LTD BERRY PLASTICS CORP BERRY PLASTICS CORP GEORGIA PACKAGING INC MAYNE PHARMA (USA) INC WOCKHARDT LTD STERIS-ISOMEDIX SERVICES II 9/28/1998 I A II II III 10/1/1998 9/30/1998 10/1/1998 II 10/1/1998 ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD SPI PHARMA VIFOR INTERNATIONAL INC BAXTER PHARMACEUTICALS SOLUTIONS LLC AMERICAN INGREDIENTS INC II 9/28/1998 BIOSEPRA SA I II II 9/25/1998 9/28/1998 ARADIGM CORP BIOSEPRA SA I A V V II 9/28/1998 9/28/1998 9/27/1998 I A II II II 9/22/1998 9/25/1998 9/1/1998 FLUROMED LP FMLP MOEHS IBERICA SL HEBEI ZHONGKANG PHARMACEUTICAL COMPANY LTD STERIS-ISOMEDIX SERVICES STERIS ISOMEDIX SERVICES AVANTI POLAR LIPIDS INC IV 9/10/1998 SOLUTIA INC A A II IV III 9/24/1998 9/23/1998 9/22/1998 ALBEMARLE CORP NEKTAR THERAPEUTICS AMPACET CORP STATUS Type SUBMIT DATE A A I I A II II II II II II 4/30/1998 4/30/1998 4/30/1998 9/21/1998 9/21/1998 9/22/1998 HOLDER SHANGHAI ASIA PIONEER CO LTD ACS DOBFAR SPA MIWON ZAMBON GROUP SPA SIEGFRIED USA LLC PHARM ECO LABORATORIES INC SUBJECT AMPHOTERICIN B CEFADROXIL MONOHYDRATE CEFACLOR MONOHYDRATE USP, NON-STERILE BULK OXAPROZIN, MANUFACTURED IN VICENZE, ITALY

4Q2012

DEXMETHYLPHENIDATE HYDROCHLORIDE AS MANUFACTURED IN PENNSVILLE, NJ 2-NSA-FORMALDEHYDE CONDENSATE, SODIUM SALT-FRACTIONED, MANUFACTURED IN LEXINGTON AND N.ANDOVER, MA PRAMOXINE HYDROCHLORIDE, MANUFACTURED IN SOUTH HAVEN, MI MPEG5000, MANUFACTURED IN HUNTSVILLE, AL 816030-P WHITE POLYETHYLENE MASTERBACH, MANUFACTURED IN KITCHENER, ONTARIO, CANADA DEQUEST 2010 DEFLOCCULANT AND SEQUESTRANT, MANUFACTURED IN NEW PORT, WALES, UNITED KINGDOM PERFLUOROHEXANES, 99.0% (APF-60M), MANUFACTURED IN ROUND ROCK, TEXAS LIDOCAINE, MANUFACTURED RUBI, SPAIN PENICILLIN G POTASSIUM CRUDE, MANUFACTURED IN HEBEI PROVINCE, PEOPLE'S REPUBLIC OF CHINA CONTRACT STERILIZATION FACILITY IN TEMECULA,CALIFORNIA CONTRACT STERILIZATION FACILITY IN CHESTER NY 1,2-DIARACHIDOYL-SN-GLYCERO-3-PHOSPHOCHOLINE, MANUFACTURED IN ALABASTER, AL AER INSULIN DIABETES MANAGMENT SYSTEM, MANUFACTURED IN HAYWARD, CA Q/S CERAMIC HYPERD ION EXCHANGERS, MANUFACTURED IN VILLENEUVE LA GARENNE (FRANCE) DEAE CERAMIC HYPERD ION EXCHANGERS, MANUFACTURED IN VILLENEUVE LA GARENNE (FRANCE) NAPROXEN SODIUM, USP (BULK), MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA DRIED ALUMINUM HYDROXIDE GEL, USP, MANUFACTURED IN LEWES, DE VENOFER CONCENTRATE USA, MANUFACTURED IN ST. GALLEN, SWITZERLAND PACKAGING MATERIALS OF VIAL DRUG PRODUCTS, MANUFACTURED IN BLOOMINGTON, INDIANA AMGRAN, MANUFACTURED BY ERIE FOODS INTERNATIONAL, INC. IN ROCHELLE, ILLINOIS LOVASTATIN, USP, MANUFACTURED IN NORTH CHICAGO, IL PROSTAGLANDIN E, MANUFACTURED IN OXEN, UNITED KINGDOM CIPROFLOXACIN HYDROCHLORIDE, USP, MANUFACTURED IN ANDHRA PRADESH, INDIA PRODUCT 11173-40, MANUFACTURED IN COLUMBUS, GA PRODUCT 41713-34, MANUFACTURED IN COLUMBUS, GA PRODUCT 41762-34, MANUFACTURED IN COLUMBUS, GA BLEOMYCIN SULFATE, MANUFACTURED IN VICTORIA, AUSTRALIA FELODIPINE, MANUFACTURED IN GUJARAT STATE, INDIA CONTRACT STERILIZATION FACILITY IN VEGA ALTA, PUERTO RICO

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4Q2012EXCEL DMF# 13257 A 13258 13259 13260 13261 13262 13263 13264 13265 A 13266 13267 I 13268 13269 13270 A 13271 A 13272 A 13273 13274 I 13275 13276 A 13277 13278 A 13279 I 13280 13281 I 13282 I 13283 13284 13285 13286 13287 13288 I I I I I I III II II II II II 10/16/1998 10/20/1998 10/15/1998 9/1/1998 9/1/1998 9/1/1998 PHYSIOR SA CHEMI SPA OTSUKA PHARMACEUTICAL CO LTD PENICK SQUIBB SQUIBB II 10/15/1998 DAICEL CHEMICAL INDUSTRIES LTD I II I 10/19/1998 10/15/1998 SANKYO CO LTD DAICEL CHEMICAL INDUSTRIES LTD CS-615 DRUG PRODUCT, MANUFACTURED IN TOKYO, JAPAN II 10/19/1998 FINORGA SA C II IV 10/22/1998 10/5/1998 MYLAN LABORATORIES LTD NOF CORP I III III 10/14/1998 10/20/1998 BASELL POLIOLEFINE ITALIA SPA FUJIMORI KOGYO CO LTD I II II 10/14/1998 9/23/1998 UBE INDUSTRIES LTD MENLA TIBETAN MEDICAL INSTITUTE III 10/7/1998 ST GOBAIN PERFORMANCE PLASTICS III 10/7/1998 ST GOBAIN PERFORMANCE PLASTICS I A II III III 6/4/1998 10/14/1998 10/7/1998 A II I 10/5/1998 9/30/1998 FABBRICA ITALIANA SINTETICI SPA OSAKA WORKS OF KOIE CHEMICAL COMPANY LIMITED GENERAL ELECTRIC MEDICAL SYSTEM SEKISUI FILM CO LTD ST GOBAIN PERFORMANCE PLASTICS I I I I I I I III III III III III III III II 9/30/1998 10/7/1998 10/7/1998 10/7/1998 10/7/1998 10/7/1998 10/7/1998 10/8/1998 STATUS Type SUBMIT DATE III 10/1/1998 HOLDER BAXTER PHARMACEUTICALS SOLUTIONS LLC HOSPIRA INC DSM RESEARCH DSM RESEARCH DSM RESEARCH DSM RESEARCH DSM RESEARCH DSM RESEARCH BRISTOL MYERS SQUIBB CO SUBJECT PACKAGING MATERIALS OF SYRINGE DRUG PRODUCTS, MANUFACTURED IN BLOOMINGTON, INDIANA ALUER VIAL SUBASSEMBLY, MANUFACTURED IN ABBOTT, ILLNOIS ARNITAL E EM400, MANUFACTURED IN EMMEN, THE NETHERLNDS ARNITEL P PM380, MANUFACTURED IN EMMEN, THE NETHERLANDS ARNITEL P PL380, MANUFACTURED IN EMMEN, THE NETHERLANDS ARNITEL E EM460, MANUFACTURED IN EMMEN, THE NETHERLANDS ARNITEL P P-X6179, MANUFACTURED IN EMMEN, THE NETHERLANDS ARNITEL P PL460, MANUFACTURED IN EMMEN, THE NETHERLANDS

4Q2012

IRBESARTAN, MANUFACTURED AT SWORDS LABORATORIES IN COUNTYDUBLIN, REP. OF IRELAND NITROFURANTOIN MONHYDRATE, MANUFACTURED IN VICENZA, ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN OSAKA, JAPAN FLUDEOXYGLUCOSE F-18 INJECTION, MANUFACTURED IN UPPSALA, SWEEDEN POLYLON TUBE, MANUFACTURED IN HIROSHIMA, JAPAN POLYESTER C1S 6022 SILICONE RELEASE COATING, MANUFACTURED IN WORCESTER, MA NATURAL HIGH DENSITY POLYETHYLENE C1S 7015 SILICONE RELEASE COATING, MANUFACTURED IN WORCESTER, MA POLYETHYLENE C1S 6113 SILICONE RELEASE COATING, MANUFACTURED IN WORCESTER, MA CS-615 DRUG SUBSTANCE, MANUFACTURED IN YAMAGUCHI, JAPAN TIBETAN HERBAL FORMULAS, MANUFACTURED AT TIBETAN HERBAL CLINIC FOR DR. YESHI DHONDEN IN DHARAMSALA, INDIA LUPOLEN 5231 HX, MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY PLASTIC FILM AND BAG FOR USE IN DRUG SUBSTANCE AND PRODUCT CONTAINERS, MANUFACTURED IN MIE PREFECTURE, JAPAN ACYCLOVIR USP (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA EXCIPIENT, DIPALMITOYL PHOSPHATIDIC ACID SODIUM SALT (DPPA-NA), MANUFACTURED IN HYOGO, JAPAN LEVOBETAXOLOL HYDROCHLORIDE, MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN NIIGATA, JAPAN CHIRALPAK AD CSP (20UM) FOR LIQUID CHROMATOGRAPHIC RESOLUTION, MANUFACTURED IN NIIGATA, JAPAN IZZO SYSTEM CARTRIDGE, MANUFACTURED IN NANTERRE, FRANCE DMPC STANDARD, MANUFACTURED IN FROSINONE, ITALY NO-1886 DRUG SUBSTANCE, MANUFACTURED IN TOKUSHIMA, JAPAN NEOMYCIN SULFATE PENICILLIN V POTASSIUM TETRACYCLINE HYDROCHLORIDE

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4Q2012EXCEL DMF# 13289 13290 13291 13292 13293 13294 13295 13296 13297 13298 13299 13300 13301 13302 13303 13304 13305 13306 13307 13308 13309 13310 13311 13312 13313 13314 13315 13316 13317 13318 13319 13320 13321 13322 13323 13324 13325 13326 13327 13328 13329 STATUS Type SUBMIT DATE I I I A I A A I I I A I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I II II II II II II II II II II II II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 II II II II II II II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 HOLDER KAYAKU CO LTD PFIZER ELI LILLY PHARMACIA AND UPJOHN SUB PFIZER INC ABBOTT SANDOZ GMBH SANDOZ GMBH SUBJECT COLISTIN SULFATE CARBENICILLIN INDANYL SODIUM PENICILLIN G PROCAINE LINCOMYCIN HYDROCHLORIDE ERYTHROMYCIN ETHYLSUCCINATE PENICILLIN G BENZATHINE PENICILLIN V POTASSIUM, MANUFACTURED IN KUNDL, AUSTRIA

4Q2012

SMITHKLINE BEECHAM PHARMACEUTICALS AMPICILLIN TRIHYDRATE SMITHKLINE BEECHAM PHARMACEUTICALS AMPICILLIN E R SQUIBB GLAXOCHEM LTD PFIZER KAYAKU PFIZER DOW CHEM PIERREL AMERICA IBI RACHELLE LABS RACHELLE LABS RACHELLE LABS ANGUS BIOTECH DIASPA DIASPA DIASPA DIASPA DIASPA DIASPA DIASPA PITMAN-MOORE PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER LABS ABBOTT BRISTOL MYERS SQUIBB COMPANY FERMENTA PRODS WYETH AYERST LABS WYETH AYERST LABS FERMENTA PRODS CHLORAMPHENICOL CHLORTETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE TETRACYCLINE OXYTETRACYCLINE HYDROCHLORIDE OXYTETRACYCLINE ERYTHROMYCIN ERYTHROMYCIN STEARATE ERYTHROMYCIN ESTOLATE CYCLOSERINE PENICILLIN G BENZATHINE PENICILLIN G PROCAINE METHACYCLINE HYDROCHLORIDE DOXYCYCLINE HYCLATE OXYTETRACYCLINE BACITRACIN ERYTHROMYCIN STEARATE KANAMYCIN SULFATE PENICILLIN G POTASSIUM PENICILLIN G PROCAINE PENICILLIN G BENZATHINE AMPICILLIN NYSTATIN AMPICILLIN TRIHYDRATE TETRACYCLINE COLISTIN SULFATE OXYTETRACYCLINE TETRACYCLINE CHLORTETRACYCLINE HYDROCHLORIDE OXYTETRACYCLINE

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4Q2012EXCEL DMF# 13330 13331 13332 13333 13334 13335 13336 13337 13338 13339 A 13340 13341 13342 13343 13344 13345 13346 13347 13348 13349 13350 13351 13352 13353 13354 13355 13356 13357 13358 13359 I 13360 A 13361 13362 13363 13364 13365 13366 13367 13368 I A C I I I I I II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 II 9/1/1998 I C I I I I I I I I I I I I I I I I I II II II II II II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 II II 9/1/1998 9/1/1998 STATUS Type SUBMIT DATE I I I I A I I I A II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 HOLDER WYETH PHARMACEUTICALS LILLY RES LABS LILLY RES LABS LILLY RES LABS PHARMACIA AND UPJOHN SUB PFIZER INC PARKE DAVIS DIV WL PHARMACIA AND UPJOHN GIST BROCADES GLAXOSMITHKLINE LLC COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SA ALPHARMA XELLIA PHARMACEUTICALS AS WYETH WYETH ALPHARMA GIST BROCADES BRISTOL MYERS SQUIBB COMPANY LEDERLE LABS ISF PLIVA PLIVA PARKE DAVIS DIV WL FERMENTA PRODS FARMITALIA CES GIST BROCADES GIST BROCADES GIST BROCADES ICN CHIMICA ICN RADIOCHEMICALS COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARL COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SA PHARMACIA AND UPJOHN XELLIA PHARMACEUTICALS APS XELLIA PHARMACEUTICALS APS PIERREL AMERICA PFIZER PFIZER PFIZER PHARMACETUICALS GROUP PFIZER BACITRACIN ZINC TYROTHRICIN PENICILLIN V POTASSIUM CHLORTETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE OXYTETRACYCLINE HYDROCHLORIDE OXYTETRACYCLINE CHLORAMPHENICOL PALMITATE DICLOXACILLIN SODIUM CHLORTETRACYCLINE HYDROCHLORIDE PENICILLIN G SODIUM PENICILLIN V POTASSIUM PENICILLIN G POTASSIUM TETRACYCLINE HYDROCHLORIDE TETRACYCLINE ERYTHROMYCIN ESTOLATE TETRACYCLINE ERYTHROMYCIN STEARATE COLISTIN SULFATE AS MANUFACTURED IN COPENHAGEN, DENMARK COLISTIMETHATE SODIUM AS MANUFACTURED IN COPENHAGEN, DENMARK AMPICILLIN TRIHYDRATE TETRACYCLINE HYDROCHLORIDE TETRACYCLINE OXYTETRACYCLINE OXYTETRACYCLINE HYDROCHLORIDE SUBJECT DEMECLOCYCLINE HYDROCHLORIDE ERYTHROMYCIN ESTOLATE PENICILLIN V POTASSIUM ERYTHROMYCIN ESTOLATE NOVOBIOCIN SODIUM CHLORAMPHENICOL ERYTHROMYCIN GRAMICIDIN GRISEOFULVIN TETRACYCLINE HYDROCHLORIDE BACITRACIN BACITRACIN STERILE USP (ESUB) AS MANUFACTURED IN OSLO NORWAY

4Q2012

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4Q2012EXCEL DMF# 13369 13370 13371 13372 13373 13374 13375 13376 13377 13378 13379 13380 13381 13382 I 13383 13384 13385 13386 13387 13388 13389 A 13390 A 13391 I 13392 13393 13394 13395 13396 13397 13398 13399 13400 13401 13402 13403 13404 13405 I I I I I I I I I I I I I I II II II II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 II 9/1/1998 II 9/1/1998 A I I I I A II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 STATUS Type SUBMIT DATE I I A A I I I I I A I I I II II II II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 HOLDER PFIZER PFIZER PFIZER INC ABBVIE INC LEDERLE LABS PFIZER PFIZER PFIZER PFIZER PHARMACIA AND UPJOHN CO WYETH AYERST LABS PFIZER IBI COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARL SANOFI AVENTIS SPA LILLY RES LABS LILLY RES LABS FERMENTA PRODS XELLIA PHARMACEUTICALS AS COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARL COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SA COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARL MEIJI SEIKA PHARMACEUTICALS POLFA DIAMOND SHAMROCK DIASPA FERMENTACIONES GYMA LABS NOVARTIS PHARM FARMITALIA CES PFIZER GLAXO GLAXO GROUP RESEARCH FERMIC SA LEDERLE LABS SUBJECT OXYTETRACYCLINE CALCIUM DOXYCYCLINE HYCLATE CLINDAMYCIN HYDROCHLORIDE ERYTHROMYCIN STEARATE (ESUB) TETRACYCLINE HYDROCHLORIDE PLICAMYCIN PENICILLIN V POTASSIUM STREPTOMYCIN SULFATE TETRACYCLINE HYDROCHLORIDE NEOMYCIN SULFATE AMPICILLIN SODIUM VIOMYCIN SULFATE ERYTHROMYCIN STEARATE AMPICILLIN TRIHYDRATE RIFAMPIN CEPHALOTHIN SODIUM CEPHALEXIN MONOHYDRATE NAFCILLIN SODIUM BACITRACIN ZINC MANUFACTURED IN OSLO NORWAY OXYTETRACYCLINE CALCIUM OXYTETRACYCLINE HYDROCHLORIDE CHLORTETRACYCLINE HYDROCHLORIDE KANAMYCIN SULFATE ERYTHROMYCIN STEARATE TETRACYCLINE HYDROCHLORIDE TETRACYCLINE TETRACYCLINE TETRACYCLINE HYDROCHLORIDE RIFAMPIN TETRACYCLINE CARBENICILLIN INDANYL SODIUM STREPTOMYCIN SULFATE DIHYDROSTREPTOMYCIN SULFATE DEMECLOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE

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SMITHKLINE BEECHAM PHARMACEUTICALS OXACILLIN SODIUM MONOHYDRATE

SMITHKLINE BEECHAM PHARMACEUTICALS METHICILLIN SODIUM

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4Q2012EXCEL DMF# 13406 I 13407 13408 13409 13410 13411 13412 13413 13414 13415 13416 13417 13418 13419 13420 13421 13422 13423 13424 13425 13426 13427 13428 13429 13430 13431 13432 13433 13434 13435 13436 13437 13438 13439 13440 13441 13442 13443 A 13444 I II 9/1/1998 IND DIV-B-M-S A I A I I A A I I I I I I I I I I I I A I I I I I I A I A I I I A A I I II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 STATUS Type SUBMIT DATE II 9/1/1998 HOLDER COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARL PFIZER INC BRISTOL MEYERS BARCELONETA INC POLFA TARCHOMIN POLFA DIAMOND SHAMROCK PHARMACIA AND UPJOHN SUB PFIZER INC PHARMACIA AND UPJOHN SUB PFIZER INC FARMITALIA CARLO ERBA SPA FARMITALIA CARLO ERBA SPA FARMITALIA CARLO ERBA SPA DISTA ISF ISF ISF PHARMACHIM BRISTOL MEYERS BARCELONETA INC TEVA PHARMACEUTICALS INDUSTRIES LTD PFIZER PHARMACIA AND UPJOHN FERSINSA GB SA DE CV BRISTOL MYERS SQUIBB COMPANY BRISTOL MYERS SQUIBB COMPANY BRISTOL MYERS SQUIBB COMPANY BRISTOL MYERS SQUIBB COMPANY BRISTOL MYERS SQUIBB COMPANY BRISTOL MYERS SQUIBB COMPANY CORDEN PHARMA LATINA SPA BRISTOL MYERS SQUIBB COMPANY CORDEN PHARMA LATINA SPA GEORGE UHE CO SCHERING PHARMACEUTI BRISTOL MYERS SQUIBB COMPANY ANTIBIOTICOS SA ANTIBIOTICOS SA BRISTOL MYERS SQUIBB COMPANY RHONE POULENC ABBVIE INC SUBJECT ERYTHROMYCIN SPECTINOMYCIN HYDROCHLORIDE AMPICILLIN TRIHYDRATE ERYTHROMYCIN OXYTETRACYCLINE CHLORTETRACYCLINE HYDROCHLORIDE CLINDAMYCIN PALMITATE HYDROCHLORIDE CLINDAMYCIN PHOSPHATE CHLORAMPHENICOL CHLORAMPHENICOL PALMITATE CYCLOSERINE PENICILLIN V POTASSIUM PENICILLIN G POTASSIUM PENICILLIN V CHLORTETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE HETACILLIN ACID AMPICILLIN TRIHYDRATE MFG IN MEXICO, MISSOURI PENICILLIN V POTASSIUM AMPICILLIN SODIUM AMPICILLIN TRIHYDRATE HETACILLIN HETACILLIN POTASSIUM DICLOXACILLIN SODIUM HETACILLIN POTASSIUM DICLOXACILLIN SODIUM OXACILLIN SODIUM OXACILLIN SODIUM (ESUB) CLOXACILLIN SODIUM AMPICILLIN (ESUB) ERYTHROMYCIN GENTAMICIN SULFATE AMPICILLIN TRIHYDRATE PENICILLIN G POTASSIUM AMPICILLIN TRIHYDRATE NYSTATIN DIHYDROSTREPTOMYCIN SULFATE

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ERYTHROMYCIN ETHYLSUCCINATE (ESUB) AS MANUFACTURED IN BARCELONETA, PUERTO RICO PENICILLIN G POTASSIUM

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4Q2012EXCEL DMF# 13445 13446 13447 13448 13449 13450 13451 13452 13453 13454 13455 13456 13457 13458 13459 13460 13461 13462 13463 13464 13465 13466 13467 13468 13469 13470 13471 13472 13473 13474 13475 13476 13477 13478 13479 13480 13481 13482 13483 13484 13485 STATUS Type SUBMIT DATE I I I I I I I I I I I I I I I I I I I I I A I A I I I I I I I I I I I I I I A I I II II II II II II II II II II II II II II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 II II II II II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 HOLDER DSM CAPUA SPA DSM CAPUA SPA GIST BROCADES ANKERMAN SPA PFIZER PFIZER PFIZER PFIZER PFIZER ARCHIFAR LAB FERMIC SA FERMIC SA FERMIC SA FERMIC SA FERMIC SA FERMIC SA FERMIC FERMIC SA ARCHIFAR LAB ERCROS SA ERCROS INDUSTRIAL SA ERCROS SA ROFERM SPA PFIZER PFIZER SOCIEDAD GLAXO GROUP RESEARCH SANDOZ INDUSTRIAL PRODUCTS SPA ARCHIFAR LAB TETRACYCLINE PHOSPHATE COMPLEX OXYTETRACYCLINE OXYTETRACYCLINE HYDROCHLORIDE TETRACYCLINE ERYTHROMYCIN ERYTHROMYCIN STEARATE ERYTHROMYCIN ESTOLATE ERYTHROMYCIN ESTOLATE OXYTETRACYCLINE HYDROCHLORIDE OXYTETRACYCLINE PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM ERYTHROMYCIN ERYTHROMYCIN STEARATE SUBJECT ERYTHROMYCIN STEARATE ERYTHROMYCIN AMPICILLIN DOXYCYCLINE OXYTETRACYCLINE OXYTETRACYCLINE HYDROCHLORIDE OXYTETRACYCLINE CALCIUM METHACYCLINE HYDROCHLORIDE DOXYCYCLINE HYCLATE TETRACYCLINE HYDROCHLORIDE ERYTHROMYCIN ERYTHROMYCIN ESTOLATE ERYTHROMYCIN STEARATE

4Q2012

SMITHKLINE BEECHAM PHARMACEUTICALS CARBENICILLIN INDANYL SODIUM SMITHKLINE BEECHAM PHARMACEUTICALS PENICILLIN G POTASSIUM

SMITHKLINE BEECHAM PHARMACEUTICALS METHICILLIN SODIUM

SMITHKLINE BEECHAM PHARMACEUTICALS CLOXACILLIN SODIUM SMITHKLINE BEECHAM PHARMACEUTICALS CLOXACILLIN BENZATHINE

SMITHKLINE BEECHAM PHARMACEUTICALS AMPICILLIN TRIHYDRATE SMITHKLINE BEECHAM PHARMACEUTICALS AMPICILLIN SODIUM SMITHKLINE BEECHAM PHARMACEUTICALS AMOXICILLIN TRIHYDRATE MEIJI SEIKA KAISHA L CORDEN PHARMA LATINA SPA BRISTOL MYERS SQUIBB COMPANY RHONE POULENC PENICILLIN G POTASSIUM CEPHAPIRIN SODIUM METHICILLIN SODIUM STREPTOMYCIN SULFATE

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4Q2012EXCEL DMF# 13486 13487 13488 13489 13490 13491 13492 13493 13494 13495 13496 13497 13498 13499 13500 13501 13502 13503 13504 13505 13506 13507 13508 13509 13510 13511 13512 13513 13514 13515 13516 13517 13518 13519 13520 13521 13522 13523 A 13524 13525 I I II II 9/1/1998 9/1/1998 STATUS Type SUBMIT DATE I I I I I I I I I I I I A A I I I I I I I I I I I I I I I I I I A I I I I II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 II II II 9/1/1998 9/1/1998 9/1/1998 HOLDER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER PFIZER AXELLIA PHARMACEUTICALS AS LEDERLE LABS BRISTOL MEYERS BARCELONETA INC CORDEN PHARMA LATINA SPA PHARMACIA AND UPJOHN SUB PFIZER INC WATSON LABORATORIES INC BRISTOL MYERS SQUIBB INDUSTRIAL DIV RHONE POULENC FERMENTA PRODS WYETH LABS AMFAIR INC KRKA DD NOVO MESTO LEDERLE LABS ABBOTT ABBOTT ABBOTT GIST BROCADES LILLY RES LABS SQUIBB ELI LILLY ANKERFARM SPA ANKERFARM SPA TEVA PHARMACEUTICALS INDUSTRIES LTD LARK ANTIBIOTICOS KYOWA HAKKO TROLEANDOMYCIN DOXYCYCLINE HYCLATE AMPICILLIN TRIHYDRATE GRAMICIDIN CHLORTETRACYCLINE HYDROCHLORIDE CEPHAPIRIN SODIUM AMOXICILLIN CLINDAMYCIN PHOSPHATE AS MANUFACTURED IN ARECIBO PR DOXYCYCLINE AS MANUFACTURED IN CULVER IN. CEPHRADINE DAUNORUBICIN HYDROCHLORIDE PENICILLIN V POTASSIUM PENICILLIN V OXYTETRACYCLINE HYDROCHLORIDE OXYTETRACYCLINE TETRACYCLINE HYDROCHLORIDE ERYTHROMYCIN ERYTHROMYCIN STEARATE ERYTHROMYCIN ETHYLSUCCINATE NAAMYCIN TOBRAMYCIN SULFATE AMPICILLIN TRIHYDRATE ERYTHROMYCIN AMPICILLIN PENICILLIN G PROCAINE AMOXICILLIN MFG IN MEXICO, MISSOURI CEPHALEXIN MONOHYDRATE TETRACYCLINE PHOSPHATE COMPLEX MITOMYCIN SUBJECT TETRACYCLINE TETRACYCLINE HYDROCHLORIDE OXYTETRACYCLINE

4Q2012

SMITHKLINE BEECHAM PHARMACEUTICALS DICLOXACILLIN SODIUM MONOHYDRATE

SMITHKLINE BEECHAM PHARMACEUTICALS CEPHRADINE

SMITHKLINE BEECHAM PHARMACEUTICALS CLOXACILLIN BENZATHINE DSM SINOCHEM PHARMACEUTICALS NYSTATIN NETHERLANDS BV SMITHKLINE BEECHAM PHARMACEUTICALS CLOXACILLIN BENZATHINE BRISTOL MEYERS BARCELONETA INC AMOXICILLIN TRIHYDRATE

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4Q2012EXCEL DMF# 13526 13527 13528 13529 13530 13531 13532 13533 13534 13535 13536 13537 13538 13539 13540 I 13541 13542 13543 13544 13545 13546 13547 13548 13549 13550 13551 I 13552 13553 13554 13555 13556 13557 13558 13559 13560 13561 13562 13563 13564 I I I I I I I I I I I I I II II II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 PIERREL AMERICA BRISTOL MEYERS BARCELONETA INC GIST BROCADES ANKERMAN SPA BRISTOL MEYERS BARCELONETA INC BRISTOL MEYERS BARCELONETA INC AMOXICILLIN TRIHYDRATE OXACILLIN SODIUM PENICILLIN V POTASSIUM AMOXICILLIN TRIHYDRATE CLOXACILLIN SODIUM DICLOXACILLIN SODIUM MONOHYDRATE I I I I I I I I A I II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 BRISTOL MYERS SQUIBB COMPANY BRISTOL MYERS SQUIBB COMPANY PFIZER PFIZER ANTIBIOTICOS INC ANTIBIOTICOS INC PHARMACIA AND UPJOHN ANTIBIOTICOS ANTIBIOTICOS SA FLAVINE INTL TETRACYCLINE HYDROCHLORIDE CLOXACILLIN SODIUM AMOXICILLIN CHLORAMPHENICOL CEPHRADINE CEPHRADINE TETRACYCLINE HYDROCHLORIDE AMPHOTERICIN B STATUS Type SUBMIT DATE I I I I I I I I I A C I I I II II II II II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 HOLDER HOECHST MARION RSSL BRISTOL MYERS SQUIBB CO APOTHEKERNES PFIZER PFIZER E R SQUIBB E R SQUIBB ISF MEIJI SEIKA KAISHA L XELLIA PHARMACEUTICALS APS SQUIBB BRISTOL GIST BROCADES SUBJECT TETRACYCLINE HYDROCHLORIDE AMIKACIN BASE NEOMYCIN SULFATE ERYTHROMYCIN STEARATE ERYTHROMYCIN AMPICILLIN SODIUM PENICILLIN G POTASSIUM CEPHALEXIN MONOHYDRATE PENICILLIN G PROCAINE

4Q2012

SMITHKLINE BEECHAM PHARMACEUTICALS CLOXACILLIN SODIUM

POLYMYXIN B SULFATE (ESUB) AS MANUFACTURED IN COPENHAGEN, DENMARK PENICILLIN G SODIUM TETRACYCLINE PHOSPHATE COMPLEX PENICILLIN G PROCAINE

CANADA PACKERS INC FINE CHEMICALS DIV AMPICILLIN TRIHYDRATE

CANADA PACKERS INC FINE CHEMICALS DIV AMOXICILLIN TRIHYDRATE

SMITHKLINE BEECHAM PHARMACEUTICALS NAFCILLIN SODIUM

SMITHKLINE BEECHAM PHARMACEUTICALS CLOXACILLIN SODIUM SMITHKLINE BEECHAM PHARMACEUTICALS AMOXICILLIN TRIHYDRATE GLAXO WELLCOME FERMENTA PRODS DUMEX ANTIBIOTICOS PENICILLIN G POTASSIUM CYCLACILLIN BACITRACIN CEPHALEXIN MONOHYDRATE

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4Q2012EXCEL DMF# 13565 13566 13567 13568 13569 13570 13571 13572 13573 13574 13575 13576 13577 13578 13579 13580 13581 13582 13583 13584 13585 13586 I 13587 13588 13589 I 13590 13591 13592 13593 13594 13595 13596 13597 13598 13599 13600 13601 13602 13603 I I I I I I I I I I I I I I II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 II 9/1/1998 I A II II II 9/1/1998 9/1/1998 9/1/1998 STATUS Type SUBMIT DATE I A I I I I I I I I A A I I I I I I I I I II II II II II II II II II II II II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 HOLDER ELI LILLY CORDEN PHARMA LATINA SPA GIST BROCADES DUMEX GIST BROCADES FERMENTA PRODS CHEMIBIOTIC IRELAND LTD CHEMIBIOTIC IRELAND LTD SANDOZ GMBH SANDOZ GMBH OLON SPA BIOCHEMIE DEUTSCHLAND GMBH PFIZER ROXANE POLFA DSM ANDENO (SZ) NIPPON KAYAKU CO LTD GIST BROCADES (IT) DUMEX PFIZER PHARM COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARL ISF ANTIBIOTICOS SA COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARL ASTRA LAKEMEDEL FERMENTA S A FERMENTA S A TRADE ELI LILLY LARK LARK FERMENTACIONES ELI LILLY PIERREL AMERICA ARCHIFAR LAB BIOCHEMIE GMBH LEDERLE LABS LEDERLE LABS AMOXICILLIN CEFAMANDOLE NAFATE CEPHRADINE AMOXICILLIN AMPICILLIN TRIHYDRATE CEFACLOR KANAMYCIN SULFATE ERYTHROMYCIN ETHYLSUCCINATE PENICILLAMINE MANUFACTURED IN KUNDL, AUSTRIA TETRACYCLINE HYDROCHLORIDE TETRACYCLINE SUBJECT CEFAMANDOLE NAFATE CEFADROXIL AMPICILLIN TRIHYDRATE BACITRACIN ZINC AMPICILLIN SODIUM CYCLOSERINE TETRACYCLINE PHOSPHATE OXYTETRACYCLINE OXYTETRACYCLINE HYDROCHLORIDE PENICILLIN G PROCAINE PAROMOMYCIN MANUFACTURED IN TURIN ITALY PENICILLIN G POTASSIUM MANUFACTURED IN FRANKFURT, GERMANY PENICILLIN G SODIUM CHLORAMPHENICOL ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE GRISEOFULVIN ERYTHROMYCIN ETHYLSUCCINATE CANDICIDIN MECLOCYCLINE SULFOSALICYLATE AMOXICILLIN TRIHYDRATE AMOXICILLIN TRIHYDRATE CEPHALEXIN MONOHYDRATE ERYTHROMYCIN ETHYLSUCCINATE BACAMPICILLIN HYDROCHLORIDE

4Q2012

SMITHKLINE BEECHAM PHARMACEUTICALS TICARCILLIN DISODIUM

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4Q2012EXCEL DMF# 13604 13605 13606 13607 13608 13609 13610 13611 13612 13613 13614 13615 13616 13617 13618 13619 13620 13621 13622 13623 13624 13625 13626 13627 13628 A 13629 I 13630 A 13631 13632 13633 13634 13635 13636 13637 I 13638 I 13639 I II 9/1/1998 II 9/1/1998 I I I I I I II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 PFIZER EGIS PHARM SIGMA CHEM ANTIBIOTICOS NANTONG PHARM HOVIONE SICHUAN LONG MARCH PHARMACEUTICAL CO LTD BRISTOL MYERS SQUIBB LABORATORIES CO LEO PHARM II 9/1/1998 II 9/1/1998 STATUS Type SUBMIT DATE I I I A C I I I A A A I I I I I I I I I I I I I II II II II II II II II II II II II II II II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 HOLDER LEDERLE LABS LEDERLE LABS LEDERLE LABS XELLIA PHARMACEUTICALS AS XELLIA PHARMACEUTICALS AS APOTHEKERNES DISTA PLANTEX USA INC ACS DOBFAR SPA ACS DOBFAR S.P.A ACS DOBFAR SPA ROUSSEL UCLAF FERMENTA PRODS TEVA PHARMACEUTICALS USA INC PHILIPS ROXANE ELI LILLY GIST BROCADES (IT) TEVA PHARMACEUTICALS USA INC ELI LILLY CONSOLIDATED PHARM CONSOLIDATED PHARM PHARMACHIM ERSANA BAYER AG SHANGHAI ASIA PIONEER PHARMACEUTICAL CORP SHANGHAI ASIA PIONEER PHARMACEUTICAL CORP SHANGHAI ASIA PHARMACEUTICAL CO LTD SUBJECT DEMECLOCYCLINE HYDROCHLORIDE DEMECLOCYCLINE CHLORTETRACYCLINE HYDROCHLORIDE BACITRACIN NON-STERILE USP AS MFG IN OSLO NORWAY

4Q2012

BACITRACIN ZINC NON-STERILE USP (ESUB) AS MANUFACTURED IN OSLO NORWAY NEOMYCIN SULFATE CEPHALEXIN AMPICILLIN TRIHYDRATE CEPHALEXIN CEPHRADINE MONOHYDRATE CEFADROXIL HEMIHYDRATE NEOMYCIN SULFATE AMOXICILLIN OXACILLIN SODIUM MFG IN MEXICO, MISSOURI CHLORAMPHENICOL CEFAMANDOLE SODIUM GENTAMICIN SULFATE CLOXACILLIN SODIUM MFG IN MEXICO, MISSOURI CEFACLOR AMPICILLIN TRIHYDRATE AMOXICILLIN GENTAMICIN SULFATE CEPHRADINE DIHYDRATE AMPICILLIN TRIHYDRATE KANAMYCIN SULFATE AS MANUFACTURED IN SHANGHAI, PEOPLE'S REPUBLIC OF CHINA DIHYDROSTREPTOMYCIN SULFATE AS MANUFACTURED IN SHANGHAI, PEOPLE'S REPUBLIC OF CHINA GENTAMICIN SULFATE AS MANUFACTURED IN SHANGHAI, PEOPLE'S REPUBLIC OF CHINA CEFOPERAZONE SODIUM CHLORAMPHENICOL DACTINOMYCIN CANDICIDIN ERYTHROMYCIN DOXYCYCLINE HYCLATE AS MANUFACTURED IN LOURES, PORTUGAL. GENTAMICIN SULFATE CEFADROXIL MONOHYDRATE BULK MANUFACTURED IN BARCELONETA,PR AMDINOCILLIN

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4Q2012EXCEL DMF# 13640 A 13641 A 13642 13643 A 13644 I 13645 13646 13647 I 13648 13649 13650 13651 13652 13653 13654 13655 13656 A 13657 13658 13659 13660 13661 13662 13663 13664 13665 13666 I 13667 I 13668 I 13669 I 13670 I 13671 I II 9/1/1998 II 9/1/1998 II 9/1/1998 II 9/1/1998 II 9/1/1998 A I A I A I A I I II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 I I I I I A A I II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 CELL PRODUCTS HOVIONE GLAXO WELLCOME GIST BROCADES (IT) ELI LILLY CORDEN PHARMA LATINA SPA ERCROS SA BRISTOL EUROPE AMPHOTERICIN B METHACYCLINE HYDROCHLORIDE CEFTAZIDIME AMIKACIN SULFATE VANCOMYCIN HYDROCHLORIDE NAFCILLIN SODIUM ERYTHROMYCIN ETHYLSUCCINATE PENICILLIN G BENZATHINE I I II II II 9/1/1998 9/1/1998 9/1/1998 II 9/1/1998 I II II 9/1/1998 9/1/1998 II 9/1/1998 STATUS Type SUBMIT DATE II 9/1/1998 HOLDER SICHUAN LONG MARCH PHARMACEUTICAL CO LTD SICHUAN LONG MARCH PHARMACEUTICAL CO LTD GIST BROCADES (IT) SICHUAN LONG MARCH PHARMACEUTICAL CO LTD SICHUAN LONG MARCH PHARMACEUTICAL CO LTD CONSOLIDATED PHARM CELL PRODUCTS SUBJECT OXYTETRACYCLINE HYDROCHLORIDE OXYTETRACYCLINE ERYTHROMYCIN ESTOLATE STREPTOMYCIN SULFATE AS MANUFACTURED IN SICHUAN, CHINA RIFAMPIN AMPICILLIN AMPHOTERICIN B

4Q2012

DISTA PRODUCTS CO DIV ELI LILLY AND CO CEFACLOR

ROCHE PHARMACEUTICALS DIV HOFFMANN CEFTRIAXONE SODIUM LAROCHE INC TEVA PHARMACEUTICALS USA INC DICLOXACILLIN SODIUM MFG IN MEXICO, MISSOURI MEIJI SEIKA KAISHA L XIAN LIJUN PHARMACEUTICAL CO LTD FARMITALIA CARLO ERBA SPA ACS DOBFAR SPA LEO PHARM CKD BIO CORP ALPHARMA CIBRAN ANSA ANTIBIOTIK VE ILAC HAMMADDERI SANAYI A/S ANSA ANTIBIOTIK VE ILAC HAMMADDERI SANAYI A/S ANSA ANTIBIOTIK VE ILAC HAMMADDERI SANAYI A/S ANSA ANTIBIOTIK VE ILAC HAMMADDERI SANAYI A/S ANSA ANTIBIOTIK VE ILAC HAMMADDERI SANAYI A/S ANSA ANTIBIOTIK VE ILAC HAMMADDERI SANAYI A/S GENTAMICIN SULFATE TETRACYCLINE HYDROCHLORIDE CYCLOSERINE AMPICILLIN SODIUM AMDINOCILLIN RIFAMPIN CALCIUM AMPHOMYCIN ERYTHROMYCIN OXYTETRACYCLINE HYDROCHLORIDE TETRACYCLINE PHOSPHATE COMPLEX TETRACYCLINE TETRACYCLINE HYDROCHLORIDE OXYTETRACYCLINE CALCIUM GENTAMICIN SULFATE

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4Q2012EXCEL DMF# 13672 I 13673 13674 13675 13676 13677 13678 13679 13680 13681 13682 13683 13684 13685 13686 13687 13688 13689 13690 13691 13692 13693 13694 13695 13696 13697 13698 13699 13700 13701 13702 13703 13704 13705 13706 A 13707 13708 13709 A 13710 A II 9/1/1998 HOVIONE FARMACIENCIA SA I I II II II 9/1/1998 9/1/1998 9/1/1998 BRISTOL MYERS SQUIBB COMPANY PFIZER ABBVIE INC CEFAZOLIN SODIUM TROLEANDOMYCIN VANCOMYCIN HYDROCHLORIDE (ESUB) I I I I I I I I I A A I I I I I I A C I I I A I I A I I I I A A I II II II II II II II II II II II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 STATUS Type SUBMIT DATE II 9/1/1998 HOLDER ANSA ANTIBIOTIK VE ILAC HAMMADDERI SANAYI A/S BRISTOL EUROPE DSM ANDENO (SZ) ELI LILLY ELI LILLY PRO CHIM RE SPA PRO CHIM RE SPA PRO CHIM RE SPA TEVA PHARMS FERMENTA PRODS XELLIA PHARMACEUTICALS APS ACS DOBFAR SPA TAKEDA CHEM IND TAKEDA CHEM IND ELI LILLY LEDERLE LABS BAYER AG LEDERLE LABS ACS XELLIA PHARMACEUTICALS APS CIBRAN CIBRAN FUJISAWA PHARM ACS DOBFAR SPA ACS ACS ACS DOBFAR SPA CEPA CIBRAN BRISTOL MYERS SQUIBB CO ABBOTT ABBVIE INC LEK PHARMACEUTICALS DD ROUSSEL UCLAF CYCLOSERINE CEFIXIME AMPICILLIN VANCOMYCIN HYDROCHLORIDE CEFAZOLIN SODIUM SUBJECT OXYTETRACYCLINE CEFORANIDE ERYTHROMYCIN ESTOLATE CEFUROXIME SODIUM ERYTHROMYCIN ESTOLATE AMOXICILLIN TRIHYDRATE AMPICILLIN TRIHYDRATE AMPICILLIN CYCLACILLIN MFG IN MEXICO, MISSOURI AMPICILLIN TRIHYDRATE AMPHOTERICIN B AS MANUFACTURED IN COPENHAGEN, DENMARK CEFTAZIDIME

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VANCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN COPENHAGEN, DENMARK ERYTHROMYCIN STEARATE ERYTHROMYCIN ESTOLATE VANCOMYCIN HYDROCHLORIDE NAFCILLIN SODIUM OXACILLIN SODIUM NAFCILLIN SODIUM CEPHAPIRIN SODIUM AMOXICILLIN LINCOMYCIN HYDROCHLORIDE AMPHOTERICIN B MANUFACTURED IN HUMACAO, PR CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN PHOSPHATE (ESUB) GENTAMICIN SULFATE CLINDAMYCIN PHOSPHATE

FUJIAN FUKANG PHARMACEUTICAL CO LTD CHLORTETRACYCLINE HYDROCHLORIDE

DOXYCYCLINE MONOHYDRATE AS MANUFACTURED IN PORTUGAL AND MACAU Page

400

4Q2012EXCEL DMF# 13711 13712 13713 13714 13715 13716 13717 13718 13719 13720 13721 13722 13723 13724 13725 13726 13727 13728 13729 13730 13731 13732 13733 13734 13735 13736 13737 13738 13739 13740 13741 13742 A 13743 A 13744 13745 13746 13747 13748 13749 A I I I I A II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 II 9/1/1998 STATUS Type SUBMIT DATE I I C A I A I A A I I I I A I C A A I I I I I I I I I A I I I II II 9/1/1998 9/1/1998 II II II 9/1/1998 9/1/1998 9/1/1998 II II II II II II II II II II II II II II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 HOLDER FERMIC SA RANBAXY LAB LTD TEVA PHARMACEUTICAL INDUSTRIES LTD HOVIONE PHARMASCIENCE LTD YOSHITOMI PHARM RANBAXY LABORATORIES LTD FERMIC SA SICHUAN PHARMACEUTICAL PLANT TEVA PHARMACEUTICALS INDUSTRIES LTD SQUIBB MFG ANGUS BIOTECH BRISTOL MYERS SQUIBB BRISTOL MYERS SQUIBB COMPANY FERSINSA GB SA DE CV GENZYME TEVA PHARMACEUTICAL INDUSTRIES LTD MEIJI SEIKA PHARMA CO LTD CORDEN PHARMA LATINA SPA DELMAR CHEMS PHARMACIA AND UPJOHN GIST BROCADES GIST BROCADES BENZEX LABORATORIES LTD ANGUS BIOTECH ANGUS BIOTECH ANGUS BIOTECH ABBOTT HOVIONE FARMACIENCIA SA PHARMACHIM PHARMACHIM TEVA PHARMS ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI CKD BIO CORP CHEMFERM CHEMFERM BIOCHEMIE NIPPON KAYAKU DSM ANTI INFECTIVES CHEMFERM SA CEFAZOLIN SODIUM MFG IN MEXICO, MISSOURI AMPICILLIN SODIUM OXACILLIN SODIUM DEMECLOCYCLINE HYDROCHLORIDE CEFADROXIL HEMIHYDRATE CEPHRADINE CEPHALEXIN MINOCYCLINE HYDROCHLORIDE CEFADROXIL MONOHYDRATE AS MANUFACTURED IN BARCELONA, SPAIN ERYTHROMYCIN ESTOLATE MINOCYCLINE HYDROCHLORIDEAS MANUFACTURED INLOURES, PORTUGAL. TOBRAMYCIN SUBJECT ERYTHROMYCIN ETHYLSUCCINATE AMPICILLIN TRIHYDRATE TOBRAMYCIN DOXYCYCLINE HYCLATE AS MANUFACTURED IN MACAU CEPHALEXIN DOXYCYCLINE HYCLATE RIFAMPIN TETRACYCLINE HYDROCHLORIDE CEPHALEXIN MFG IN MEXICO, MISSOURI CEPHALEXIN ERYTHROMYCIN AMIKACIN SULFATE CEPHALEXIN PENICILLIN G POTASSIUM CLINDAMYCIN PHOSPHATE DOXORUBICIN HYDROCHLORIDE DAUNORUBICIN HYDROCHLORIDE AMPICILLIN TRIHYDRATE CLINDAMYCIN PHOSPHATE VIDARABINE AMOXICILLIN PENICILLIN G BENZATHINE CEPHALEXIN ERYTHROMYCIN STEARATE

4Q2012

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4Q2012EXCEL DMF# 13750 13751 13752 13753 13754 13755 13756 13757 A 13758 A 13759 13760 I 13761 13762 13763 13764 13765 13766 13767 13768 13769 13770 I 13771 13772 13773 A 13774 A 13775 A 13776 13777 13778 13779 13780 13781 13782 13783 A 13784 A II 9/1/1998 TEVA PHARMACEUTICAL INDUSTRIES LTD BLEOMYCIN SULFATE A A A I A I I II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 II 9/1/1998 II 9/1/1998 A A II II II 9/1/1998 9/1/1998 9/1/1998 CHONGZHOU PHARMACEUTICAL FACTORY DAEWOONG BIO INC DOXYCYCLINE HYCLATE AMOXICILLIN I A A A A I A A I II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 A II II 9/1/1998 9/1/1998 II 9/1/1998 STATUS Type SUBMIT DATE I A I A A I I II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 HOLDER BARCELONETA SANDOZ GMBH LUPIN LAB LTD JIANGXI GUOYAO PHARMACEUTICAL LLC SANDOZ GMBH KYOWA HAKKO KOGYO ABBOTT LABS SUZHOU NUMBER 4 PHARMACUTICAL FACTORY COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SA RANBAXY LABORATORIES LTD SUBJECT CEFAZOLIN SODIUM MANUFACTURED IN BARCELONETA, PR PENICILLIN G SODIUM (STERILE) MANUFACTURED IN KUNDL, AUSTRIA CEPHALEXIN LINCOMYCIN HYDROCHLORIDE AMPICILLIN SODIUM (STERILE), MANUFACTURED IN KUNDL, AUSTRIA MINOCYCLINE HYDROCHLORIDE AMIKACIN SULFATE LINCOMYCIN HYDROCHLORIDE MANUFACTURED IN SUZHOU, CHINA MINOCYCLINE HYDROCHLORIDE CEPHALEXIN

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ZHEJIANG HISUN PHARMACEUTICAL CO LTD TOBRAMYCIN

ZHEJIANG HISUN PHARMACEUTICAL CO LTD DOXORUBICIN HYDROCHLORIDE AS MANUFACTURED IN JIAOJIANG, ZHEJIANG PROVINE, CHINA CHONGQING DAXIN PHARMACEUTICAL CO TOBRAMYCIN AS MANUFACTURED IN CHONGQING, CHINA LTD ZHEJIANG HISUN PHARMACEUTICAL CO LTD DAUNORUBICIN HYDROCHLORIDE AS MANUFACTURED IN JIAOJIANG, ZHEJIANG PROVINE, CHINA FERMENTACIONES Y SINTESIS SA DE CV AMOXICILLIN TRIHYDRATE FERSINSA GB SA DE CV KDL BIOTECH LTD BRISTOL-MYERS ACS DOBFAR SPA TAIWAN BIOTECH GIST BROCADES AMPICILLIN AMOXICILLIN TRIHYDRATE AMPICILLIN CEFACLOR MONOHYDRATE CEPHALEXIN PENICILLIN G POTASSIUM

ZHEJIANG HISUN PHARMACEUTICAL CO LTD MITOMYCIN AS MANUFACTURED IN JIAOJIANG, ZHEJIANG PROVINE, CHINA

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4Q2012EXCEL DMF# 13785 13786 13787 A 13788 A 13789 13790 13791 13792 13793 13794 13795 13796 13797 13798 13799 13800 13801 A 13802 13803 13804 I 13805 13806 13807 I 13808 I 13809 I 13810 13811 13812 I 13813 13814 I 13815 13816 13817 I I A V III IV 8/11/1998 11/2/1998 11/4/1998 STERIGENICS INTERNATIONAL REXAM HEALTHCARE PACKAGING INC CENTRAL SOYA CO INC A III III 10/26/1998 10/26/1998 BERRY PLASTICS CORP MAC CLOSURES INC A I II II IV 10/30/1998 10/20/1998 11/2/1998 II 10/30/1998 I 9/30/1998 I A II II II 10/23/1998 10/30/1998 10/29/1998 SOLVAY SOLEXIS INC APTUIT INC I I II II I 10/21/1998 10/23/1998 10/23/1998 A I C A I C A A I A A A II II II II II II II II II II II II II 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 9/1/1998 10/23/1998 II 9/1/1998 STATUS Type SUBMIT DATE A C II II II 9/1/1998 9/1/1998 9/1/1998 HOLDER MICROBIOPHARM JAPAN CO LTD TEVA PHARMACEUTICAL INDUSTRIES LTD CHONGQING CARE LIFE PHARMACEUTICAL CO LTD CHONGQING DAXIN PHARMACEUTICAL CO LTD CHEMWERTH INC RANBAXY LABORATORIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD MYTHEN SPA TEVA PHARMS XELLIA PHARMACEUTICALS LTD SANDOZ INDUSTRIAL PRODUCTS SA FIDIA FARMACEUTICI SPA ASTELLAS PHARMA INC SANDOZ INDUSTRIAL PRODUCTS SA TEVA PHARMACEUTICALS INDUSTRIES LTD ABBVIE INC LABORATORIO CHIMICO INTERNAZIONALE SPA DIPHARMA SPA AVECIA BIOTECHNOLOGY INC SKYEPHARMA PLC SUBJECT MITOMYCIN DAUNORUBICIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE AS MANUFACTURED IN CHONGQING, CHINA AMIKACIN SULFATE AS MANUFACTURED IN CHONGQING, CHINA CYCLOSPORINE AS MANUFACTURED IN FUJIAN, CHINA FOR CHEMWERTH INC CEFACLOR MITOMYCIN DEMECLOCYCLINE HYDROCHLORIDE CEPHRADINE MFG IN MEXICO, MISSOURI VANCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN BUDAPEST HUNGARY PENICILLIN V POTASSIUM,MANUFACTURED IN KUNDL, AUSTRIA RIFAMPIN CEFAZOLIN SODIUM (STERILE) DICLOXACILLIN SODIUM CYCLOSPORINE CYCLOSPORINE (ESUB) FENOFIBRATE, MANUFACTURED IN MILANO, ITALY DIBENZOSUBERENONE, MANUFACTURED IN MERETO DI TOMBA (UD)-ITALY OLIGONUCLEOTIDE MG98 API, MANUFACTURED IN MILFORD, MA MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN CEDEX, FRANCE FOMBLIN Y25 TSP, MANUFACTURED IN SPINETTA MARENGO (AL), ITALY

4Q2012

MILRINONE DRUG SUBSTANCE, MANUFACTURED IN HARRISONVILLE, MISSOURI

BASF PHARMACHEMIKALIEN GMBH AND CO DOXAZOSIN MESYLATE, MANUFACTURED BY QCI IN DAYTON OHIO KG KOEI CHEMICAL CO LTD MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN OSAKA, JAPAN BACHEM INC HUMAN GROWTH HORMONE RELEASING FACTOR (1-44), AMIDE, ACETATE (BULK), MANUFACTURED IN SAN DIEGO, CALIFORNIA FERMION OY DEXMEDETOMIDINE HYDROCHLORIDE, MANUFACTURED IN ESPOO, FINLAND INKE SA LIPOID GMBH LORATIDINE, MANUFACTURED IN BARCELONA, SPAIN LIPOID PG 16:0/18:1-NH4 (1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHATIDYL GLYCEROL AMMONIUM SALT)MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY PRODUCT 24-3-090 AS MANUFACTURED IN HOMER, LA RECLOSABLE CONTINUOUS THREADED LE STYLE STRIPPED CLOSURE, MANUFACTURED IN QUEBEC, CANADA ELECTRON BEAM FACILITY IN SAN DIEGO, CA PACKAGING COMPONENTS, MANUFACTURED IN BUFFALO GROVE, IL SOY LECITHIN, ETC., MANUFACTURED IN DECATUR AND REMINGTON, IN AND BELLEVUE, OH Page 403

4Q2012EXCEL DMF# 13818 13819 13820 13821 13822 13823 13824 13825 13826 I 13827 A 13828 13829 13830 13831 13832 13833 I 13834 13835 13836 13837 13838 13839 13840 I 13841 A 13842 13843 13844 13845 13846 13847 13848 13849 13850 13851 I 13852 I II 11/19/1998 UCB SA PHARMACEUTIQUE SECTEUR I A A I A A I I I II II II II II III II II II II 11/12/1998 11/12/1998 11/19/1998 11/16/1998 10/29/1998 11/18/1998 11/18/1998 11/18/1998 11/18/1998 11/16/1998 MEDICHEM SA CHATTEM CHEMICALS INC CHEMAGIS LTD ORGANICHEM CORP BIDACHEM SPA KOHAP LTD PENINSULA LABORATORIES INC PENINSULA LABORATORIES INC PENINSULA LABORATORIES INC SOLMAG SPA III 11/11/1998 ST GOBAIN PERFORMANCE PLASTICS A I A A A I IV II II II II II III 11/9/1998 11/9/1998 11/9/1998 11/12/1998 11/12/1998 11/11/1998 11/12/1998 ASAHI KASEI CHEMICALS CORP DR REDDYS LABORATORIES LTD DR REDDYS LABORATORIES LTD ISO TEX DIAGNOSTICS INC ISO TEX DIAGNOSTICS INC MALLINCKRODT INC COURTAULDS PACKAGING LTD I I I A A III III III II IV I 11/8/1998 11/9/1998 11/11/1998 11/5/1998 11/19/1998 11/9/1998 ROPACK INC 3M PHARMACEUTICALS INC HUMPHREY COSBURN PLASTICS EUTICALS SPA BAYER SCHERING PHARMA AG ASAHI CHEMICAL INDUSTRY CO LTD II 11/9/1998 STATUS Type SUBMIT DATE A I A I A I A I III II II III II III IV II II 10/30/1998 11/5/1998 11/5/1998 11/2/1998 11/6/1998 11/5/1998 11/9/1998 11/9/1998 11/4/1998 HOLDER HONEYWELL ASENCE PHARMA PVT LTD RANBAXY LABORATORIES LTD HENKEL CORP BACHEM AG CFC INTERNATIONAL INC WILD FLAVORS INC PHARMACIA AND UPJOHN SPA HUIANG BIO CHEMICAL PRODUCT MANUFACTURE COMPANY LTD TAPI PUERTO RICO INC SUBJECT ACLAM LAMINATE STRUCTURES, MANUFACTURED IN MORRISTOWN, NJ AMPHOTERICIN B, MANUFACTURED IN GUJARAT, INDIA ENALAPRIL MALEATE, MANUFACTURED IN PUNJAB, INDIA MACROMELT 6900, MANUFACTURED IN KANKAKEE, IL LEUPROLIDE ACETATE, MANUFACTURED IN BUBENDORF, SWITZERLAND PIGMENTED FOILS, MANUFACTURED IN CHICAGO HEIGHTS, IL

4Q2012

NATURAL PEPPERMINT FLAVOR WONF #112136, MANUFACTURED IN ERLANGER, KY IODODOXORUBICIN HCI BULK DRUG SUBSTANCE MANUFACTURED IN MILAN, ITALY PACLITAXEL, MANUFACTURED IN GUILIN, CHINA METFORMIN HYDROCHLORIDE DRUG SUBSTANCE, MANUFACTURED IN GUAYAMA, PUERTO RICO BULK DRUG PACKAGING AS LOCATED IN QUEBEC, CANADA D96171 SPRAYMISER VALVE, MANUFACTURED IN LANCASHIRE, GREAT BRITAIN PACKAGING FOR CYCLOSPORIN, MANUFACTURED IN ONTARIO, CANADA PIRENZEPINE DIHYDROCHLORIDE, MANUFACTURED IN LODI, ITALY PDMS 372 TUBING, MANUFACTURED IN TURKU, FINLAND MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATIONAL PROCEDURES IN TOKYO, JAPAN MICROCRYSTALLINE CELLULOSE, CEOLUS KG, MANUFACTURED IN TOKYO, JAPAN ENALAPRILAT, USP, MANUFACTURED IN ANDHRA PRADESH, INDIA ENALAPRIL MALEATE, USP, MANUFACTURED IN ANDHRA PRADESH, INDIA PT-195M CIS-PLATIN, MANUFACTURED IN FRIENDSWOOD, TEXAS PLATINUM-195M, MANUFACTURED IN FRIENDSWOOD, TEXAS PROSAPTIDE TX 14(A), CODE 8200, MANUFACTURED IN ST. LOUIS, MO ALBUTEROL 300 DOSE ACTUATOR PROJECT, MANUFACTURED IN WREXHAM, UNITED KINGDOM POLYESTER/9022 FLUOROSILICONE RELEASE COATING, MANUFACTURED IN WORCESTER, MA LORATIDINE, MANUFACTURED IN GERONA, SPAIN AMMONIUM LACTATE, MANUFACTURED IN CHATTANOOGA, TN GRANISETRON HYDROCHLORIDE, MANUFACTURED IN BEER SHEVA, ISRAEL 4-METHOXYPHENOL, MANUFACTURED IN LINZ, AUSTRIA MELOXICAM, MANUFACTURED IN FOMOVO S GIOVANNI (BG), ITALY PAPET (TM) POLYESTER RESIN, MANUFACTURED IN ULSAN AND KYUNGGI-DO, KOREA ALA-10-ASP, MANUFACTURED IN SAN CARLOS, CALIFORNIA GLU-10-THR, MANUFACTURED IN SAN CARLOS, CALIFORNIA ASP-10-GLU, MANUFACTURED IN SAN CARLOS, CALIFORNIA BUPROPION HYDROCHLORIDE, MANUFACTURED IN GARBAGNATE MILANESE (MI), ITALY HYDROXYZINE HYDROCHLORIDE COMPACTED, MANUFACTURED IN BRAINE-L ALLEUD BELGIUM

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4Q2012EXCEL DMF# 13853 I 13854 A 13855 13856 13857 13858 13859 I 13860 I 13861 13862 13863 I 13864 13865 13866 13867 13868 I 13869 13870 13871 13872 13873 I 13874 13875 I 13876 13877 13878 13879 I 13880 I 13881 I 13882 A II 11/30/1998 SHASUN PHARMACEUTICALS LTD II 11/19/1998 PROTEIN TECHNOLOGIES INTERNATIONAL INC II 11/19/1998 PROTEIN TECHNOLOGIES INTERNATIONAL INC I I A II II II IV 12/4/1998 12/4/1998 12/3/1998 12/4/1998 I II III 12/2/1998 11/19/1998 FINORGA LEXINGTON MEDICAL DIV LEXINGTON COMPONENTS SICOR SPA SICOR SPA ASTELLAS IRELAND CO LTD DERIVADOS MACROQUIMICOS SA DE CV A A I I II II III III II 11/24/1998 11/27/1998 11/20/1998 11/25/1998 11/30/1998 FARMHISPANIA SA BOEHRINGER INGELHEIM ESPANA SA POLIMERI EUROPA FRANCE SA POLIMERI EUROPA LIPOID GMBH A I A A III II II II I 11/24/1998 11/24/1998 11/27/1998 11/27/1998 11/25/1998 A A II II II 11/25/1998 11/24/1998 11/25/1998 TARO PHARMACEUTICAL INDUSTRIES LTD DR REDDYS LABORATORIES LTD UNIVERSITY OF WISCONSIN FOOD RESEARCH INSTITUTE ONGROPACK LTD MALLINCKRODT INC DIVIS LABORATORIES LTD DIVIS LABORATORIES LTD PROGEN INDUSTRIES LIMITED III 11/16/1998 BACHEM AMERICAS INC A I I I IV II II II III 11/16/1998 11/10/1998 11/23/1998 11/23/1998 11/19/1998 II 10/16/1998 STANDARD CHEMICAL AND PHARMACEUTICAL CO LTD LUBRIZOL ADVANCED MATERIALS INC ESTEVE QUIMICA SA JACOBUS PHARMACEUTICAL CO INC RUIBANG LABORATORIES REXAM CONSUMER PLASTICS INC STATUS Type SUBMIT DATE I 10/16/1998 HOLDER STANDARD CHEM AND PHARM CO LTD SUBJECT

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN TAIWAN, R.O.C. DEXTROMETHORPHAN HYDROBROMIDE USP, MANUFACTURED IN TAIWAN, R.O.C. CARBOPOL 1984, 2984 AND 5984 RESINS, MANUFACTURED IN CALVERT CITY, KY NEFAZODONE HYDRCHLORIDE, MANUFACTURED IN TARRAGONA, SPAIN PROGUANIL HYDROCHLORIDE, MANUFACTURED IN PRINCETON, NEW JERSEY CYCLOSPORINE, MANUFACTURED IN ZHEJIANG, PEOPLE'S REPUBLIC OF CHINA ACTUATOR AND/OR STRAPCAP COMPONENTS, MANUFACTURED IN BUFFALO GROVE, ILLINOIS WHITE POLYETHYLENE MASTERBACH, MANUFACTURED IN TERRE HAUTE IN,DERIDDER, LA, CARTERSVILLE, GA AND MESSANCY, BELGIUM DESOXIMETASONE, MANUFACTURED IN HAIFA BAY, ISRAEL CIPROFLOXACIN HYDROCHLORIDE, USP, MANUFACTURED IN ANDHRA PRADESH, INDIA PREPARATION OF BOTULINUM TOXINS A THROUGH G FOR MOUSE NEUTRALIZATION ASSAYS, MANUFACTURED IN MADISON, WISCONSIN ONGROFOL KTE-101 RIGID PVC FILM, MANUFACTURED IN BOLYAI TER 1, HUNGARY PEMOLINE MALLINCKRODT CODE 1500, MANUFACTURED IN ST. LOUIS, MISSOURI NAPROXEN USP, MANUFACTURED IN ANDHRA PRADESH, INDIA NAPROXEN SODIUM USP, MANUFACTURED IN ANDHRA PRADESH, INDIA MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN DARRA, AUSTRALIA METFORMIN HYDROCHLORIDE, MANUFACTURED IN BARCELONA, SPAIN DIPYRIDAMOLE API, MANUFACTURED IN MALGRAT DE MAR-SPAIN RIBLENE FL20, MANUFACTURED IN DUNKIRK, FRANCE AND FERRARA, ITALY GREENFLEX FF 35, MANUFACTURED IN OBERHAUSEN, GERMANY LIPOID PG 16:0/18:1-NH4 (1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3- PHOSPHATIDYL GLYCEROL AMMONIUM SALT)MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY TIAPRIDE HYDROCHLORIDE, MANUFACTURED IN MOURENX, FRANCE PACKAGING MATERIALS USED IN SHORT TERM EXTERNALLY COMMUNICATING DEVICES, MANUFACTURED IN ROCK HILL, SC IDARUBICIN AGLYCONE (BULK CHEMICAL), MANUFACTURED ITALY DAUNOSAMINE TFA ACETATE (BULK CHEMICAL), MANUFACTURED IN MILAN, ITALY TAMSULOSIN HYDROCHLORIDE, MANUFACTURED IN DUBLIN, IRELAND HYDROPROPYL METHLCELLULOSE, MANUFACTURED IN ZACAPU, MICHOACAN, MEXICO PTI G-2535 (UNCONJUGATED ISOFLAVONES-70) CAPSULES 150 MG GENISTEIN ACTIVITY/CAPSULE, MANUFACTURED BY UNIVERSITY PHARMACEUTICALS OF MARYLAND INC. IN BALTIMORE, MARYLAND PTI G-4660 (UNCONJUGATED ISOFLAVONES - 100) CAPSULES 150 MG GENISTEIN ACTIVITY/CAPSULE, MANUFACTURED BY UNIVERSITY PHARMACEUTICALS OF MARYLAND INC. IN BALTIMORE, MARYLAND NAPROXEN, USP, MANUFACTURED IN PONDICHERRY, INDIA

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4Q2012EXCEL DMF# 13883 13884 13885 13886 13887 13888 I 13889 13890 I 13891 I 13892 13893 13894 13895 13896 13897 I 13898 A 13899 A 13900 A 13901 A 13902 13903 I 13904 13905 13906 I 13907 A 13908 13909 13910 13911 A 13912 13913 I A II II 12/23/1998 12/23/1998 A A A II II II II 12/22/1998 12/18/1998 12/22/1998 12/24/1998 SUMITOMO CHEMICAL CO LTD UBE INDUSTRIES LTD CORDEN PHARMA LTD HERAEUS PRECIOUS METALS GMBH AND CO KG CHEMI SPA TEVA PHARMACEUTICAL INDUSTRIES LTD II 12/17/1998 NEOMPS INC A I II II II 12/17/1998 12/21/1998 12/22/1998 EXCELLA GMBH HOSPIRA INC RESTORAGEN INC ENALAPRILAT, (ESUB) MANUFACTURED IN FEUCHT, GERMANY TEQUIN I.V. (GATIFLOXACIN), MANUFACTURED IN NORTH CHICAGO, ILLINOIS I II III 12/18/1998 12/18/1998 KYORIN PHARMACEUTICAL CO LTD RHODIA FILTEC INDUSTRIAL YARNS III 12/10/1998 II 12/18/1998 II 12/18/1998 II 12/18/1998 I A I I I II II II II II II 12/10/1998 12/14/1998 12/14/1998 12/14/1998 12/15/1998 12/16/1998 DIOSYNTH BV BAYER SCHERING PHARMA AG PENINSULA LABORATORIES INC NV ORGANON PFANSTIEHL LABORATORIES INC SHANXI HANCHENG PHARMACEUTICAL FACTORY DSM SINOCHEM PHARMACEUTICALS NETHERLANDS BV DSM SINOCHEM PHARMACEUTICALS NETHERLANDS BV DSM SINOCHEM PHARMACEUTICALS NETHERLANDS BV ST GOBAIN PERFORMANCE PLASTICS III 12/8/1998 AMPACET CORP I II II 12/7/1998 12/8/1998 PHARMACIA AND UPJOHN SPA ELI LILLY AND CO STATUS Type SUBMIT DATE A C A I I II II III III II II 12/3/1998 12/7/1998 12/1/1998 12/7/1998 12/7/1998 12/7/1998 HOLDER ERREGIERRE SPA TEVA PHARMACEUTICAL INDUSTRIES LTD ZEON CORP DSM RESEARCH CIPLA LTD SUMITOMO CHEMICAL CO LTD SUBJECT MESALAMINE, MANUFACTURED IN BERGAMO, ITALY IDARUBICIN HYDROCHLORIDE, MANUFACTURED IN MILAN, ITALY

4Q2012

CYCLOOLEFIN POLYMER (ZEONOR 1020R), MANUFACTURED IN OKAYAMA, JAPAN VESTOLEN A 6016 L-O, MANUFACTURED IN GELSENKIRCHEN, GERMANY 16A-BROMOEPIANDROSTERONE, MANUFACTURED IN MUMBAI, INDIA PAROXETINE HYDROCHLORIDE ANHYDRATE, MANUFACTURED IN ANPACHIGUN, GIFU PREFECTURE, JAPAN IODODOXORUBICIN HCI FOR INJECTION, MANUFACTURED IN MILAN, ITALY DIPEPTIDYLAMINOPEPTIDASE (DDAP), MANUFACTURED IN LILLY FRANCE S.A. IN FEGERSHEIM, FRANCE 100099 UV BARRIER, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA AND MESSANCY, BELGIUM FLUVOXAMINE MALEATE, MANUFACTURED IN AK APELDOORN, THE NETHERLANDS PYNASUNATE, MANUFACTURED IN BERLIN, GERMANY GLU-11-VAL, MANUFACTURED IN SAN CARLOS, CALIFORNIA TIBOLONE, MANUFACTURED IN OSS, THE NETHERLANDS SODIUM DICHLOROACETATE, MANUFACTURED IN WAUKEGAN, IL DROPERIDOL USP, NON-STERILE BULK DRUG INTENDED FOR HUMAN USE, MANUFACTURED IN SHANXI PROVINCE, CHINA CLAVULANATE POTASSIUM MIXTURE WITH SILICONE DIOXIDE IN THE RATIO 1:1, MANUFACTURED IN STRAGNAS,SWEDEN CLAVULANATE POTASSIUM MIXTURE WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO 1:1, MANUFACTURED IN STRAGNAS, SWEDEN CLAVULANATE POTASSIUM, MANUFACTURED IN STRAGNAS, SWEDEN 53# BLEACHED KRAFT C1S 7015 SILICONE RELEASE COATING, MANUFACTURED IN WORCESTER, MA GATIFLOXACIN, MANUFACTURED IN OKAYA-SHI NAGANO, JAPAN POLYESTER GRANULAT 74K40Z108, MANUFACTURED IN EMMENBRUCKE, SWITZERLAND

RECOMBINANT GLUCAGON-LIKE PEPTIDE-1 (RGLP), MANUFACTURED IN LINCOLN, NEBRASKA SYNTHETIC PEPTIDES MPS-74, MPS-75, MPS-76, MPS-77, AND MPS-78, MANUFACTURED IN SAN DIEGO, CA POTASSIUM OTASTAT, MANUFACTURED IN GIFU PREFECTURE, JAPAN 6,7-DIFLUOROESTER FORM, MANUFACTURED IN YAMAGUCHI, JAPAN BISOPROLOL FUMARATE, MANUFACTURED IN CORK, IRELAND THIOTEPA USP, MANUFACTURED IN HANAU, GERMANY DSPC(1,2-DISTEAROYL-PHOPHAIDYCHLOINE), MANUFACTURED IN FROSINONE, ITALY FLUVOXAMINE MALEATE, MANUFACTURED IN GUAYAMA, PUERTO RICO

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4Q2012EXCEL DMF# 13914 I 13915 I 13916 I 13917 I 13918 13919 13920 I 13921 13922 13923 13924 13925 I 13926 13927 13928 I 13929 13930 I 13931 13932 13933 13934 13935 13936 13937 I 13938 13939 13940 13941 13942 13943 13944 13945 13946 13947 I I I A A I A A A I III II II IV II III II II II II 1/12/1999 1/13/1999 12/31/1998 1/15/1999 1/18/1999 1/19/1999 1/13/1999 1/15/1999 1/18/1999 1/11/1999 RICON COLORS PENINSULA LABORATORIES INC AVANTI POLAR LIPIDS INC EVONIK ROHM GMBH BOEHRINGER INGELHEIM CHEMICALS INC PRETIUM PACKAGING YANGZHOU PHARMACEUTICAL CO LTD SANOFI AVENTIS DEUTSCHLAND GMBH TEVA PHARMACEUTICAL INDUSTRIES LTD LONZA LTD A I I I I A IV II IV II II III III 1/4/1999 1/8/1999 1/4/1999 1/8/1999 1/12/1999 1/6/1999 1/13/1999 A II III 1/4/1999 12/28/1998 APOTEX PHARMACHEM INC KERR SUN COAST FOOD AND BEVERAGE GROUP PHOSPHOLIPID GMBH MALLINCKRODT INC WILD FLAVORS INC CAMBREX PROFARMACO CORK LTD TOYAMA CHEMICAL CO LTD BERRY PLASTICS CORP CCC PLASTICS I A II II III 12/21/1998 12/21/1998 12/29/1998 VEREIN FUR KREBSFORSCHUNG SIFAVITOR SRL CRYOVAC A I I I II II II II I 12/30/1998 12/29/1998 8/15/1998 12/30/1998 12/18/1998 TARO PHARMACEUTICAL INDUSTRIES LTD PENINSULA LABORATORIES INC PYRETHRUM BOARD OF KENYA ORGANICHEM CORP VEREIN FUR KREBSFORSCHUNG I I III II II 12/23/1998 12/29/1998 12/24/1998 II 12/23/1998 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA ALVEO AG PLIVA DD EURORESEARCH S.R.L. LOVASTATIN, MANUFACTURED IN MILANO, ITALY ALVEOLIT TEE 0500 SKIN, MANUFACTURED IN LUZERN, SWITZERLAND PEMOLINE, MANUFACTURED IN SAVSKI MAROF, CROTIA III 12/22/1998 MY HEALTHCARE INTALY S.R.L. I 1/8/1999 STATUS Type SUBMIT DATE III 12/29/1998 HOLDER MARUTANI CHEMICAL PLANT & ENGINEERING CO., LTD DEXCEL LTD SUBJECT

4Q2012

HI-DRYPACK FOR PACKAGING TABLETS & CAPLETS, MANUFACTURED IN IBARAGI PREFECTURE, JAPAN MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN OR AKIVA, ISRAEL PRINTED ALUMINUM FOIL, MANUFACTURED IN L CASONI-PODENZANO (PIACENZA)-ITALY

BISKALCITRATE LYOPHILIZED, POTASSIUM SALT (ORAL), MANUFACTURED IN MILANO, ITALY HYDROCORTISONE 17-VALERATE, USP, MANUFACTURED IN HAIFA BAY, ISRAEL LEUPROLIDE, MANUFACTURED IN SAN CARLOS, CALIFORNIA PYRETHRUM, MANUFACTURED IN NAKURU, KENYA HYPERPOLARIZED HELIUM-3 GAS (HP-3HE), MANUFACTURED IN SOUTH PLAINFIELD, NJ MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN ARLESHEIM, SWITZERLAND CANNADOR MANUFACTURED IN ARLESHEIM, SWITZERLAND BUPROPION HYDROCHLORIDE, MANUFACTURED IN LODI, ITALY M371, OXYGEN BARRIER MEDICAL PACKAGING MATERIAL, MANUFACTURED IN DUNCAN, SOUTH CYCLOSPORINE USP (BULK) MANUFACTURED IN WINNIPEG, MANITOBA, CANADA LINED PLASTIC INJECTION MOLDED CLOSURE (BOTTLE CAP), MANUFACTURED IN SARASOTA, FL PHOSOL 50 PG, MANUFACTURED IN COLOGNE, GERMANY EXENDIN-4, MANUFACTURED IN TORRANCE, CA ARTIFICIAL STRAWBERRY FLAVOR #FACN402, MANUFACTURED IN ERLANGER, KY DICLOFENAC POTASSIUM, MANUFACTURED INCORK, IRELAND T-3811ME DRUG SUBSTANCE, MANUFACTURED IN OSAKA, JAPAN PENICILLIN V POTASSIUM, MANUFACTURED IN SLOVENSKA LUPCA, SLOVAKIA WHITE MB50-902 POLYPROPYLENE COLOUR CONCENTRATE, MANUFACTURED IN ONTARIO, CANADA WHITE, CPP-W368-1, MANUFACTURED IN ONTARIO, CANADA DESLORELIN, MANUFACTURED IN SAN CARLOS, CALIFORNIA L-A-PHOSPHATIDYL-DL-GLYCEROL (EGG), MANUFACTURED IN ALABASTER, AL EUDRAGIT FS 30 D, MANUFACTURED IN DARMSTADT, GERMANY METHADONE HYDROCHLORIDE USP, MANUFACTURED IN PETERSBURG, VA PACKAGING MATERIALS, MANUFACTURED IN EASTON, PA DOXYCYCLINE MONOHYDRATE, MANUFACTURED IN JIANGSU PROVINCE, CHINA HR1799, MANUFACTURED IN FRANKFURT, GERMANY PAMIDRONATE BULK CHEMICAL, MANUFACTURED IN MILAN, ITALY L-CARNITINE USP, MANUFACTURED IN VISP, SWITZERLAND

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4Q2012EXCEL DMF# 13948 13949 13950 A 13951 I 13952 13953 I 13954 13955 13956 I 13957 A 13958 13959 13960 A 13961 A 13962 13963 13964 I 13965 A 13966 13967 13968 13969 13970 I 13971 13972 A 13973 I 13974 I 13975 13976 13977 13978 I I A I II II II III 2/8/1999 2/9/1999 2/16/1999 1/28/1999 MEDI-CULT A/S UNIVERSITY OF MICHIGAN PRODUCTOS QUIMICOS NATURALES SA SOLVAY POLYOLEFINS EUROPE SA I 2/8/1999 MEDI-CULT A/S III 2/3/1999 A II II 2/4/1999 2/9/1999 NV ORGANON PRODUCTOS QUIMICOS NATURALES SA DE CV AMPACET CORP A A I A II II III II II 1/29/1999 1/22/1999 2/3/1999 1/29/1999 12/4/1998 UNIGENE LABORATORIES INC SIMAFEX SAS FINA RESEARCH SA INTERNATIONAL SPECIALTY PRODUCTS CULTOR FOOD SCIENCE INC II 1/29/1999 TEVA PHARMACEUTICAL INDUSTRIES LTD C A II II III 1/29/1999 1/29/1999 1/29/1999 TEVA PHARMACEUTICAL INDUSTRIES LTD BIOTIKA SA AMPACET CORP II 1/29/1999 GLAXOSMITHKLINE LLC A A III II II 1/18/1999 1/26/1999 1/25/1999 ACCEL COLOR CORP TEVA PHARMACEUTICAL INDUSTRIES LTD PQ CORP II 1/22/1999 ALKERMES GAINESVILLE LLC I A III II II 1/20/1999 1/21/1999 1/22/1999 LUBRIZOL ADVANCED MATERIALS INC ANALYTECON SA 3M PHARMACEUTICALS INC I II III 12/4/1998 1/20/1999 CULTOR FOOD SCIENCE INC AMPACET CORP I 12/4/1998 STATUS Type SUBMIT DATE A A II V II 12/29/1998 1/13/1999 1/19/1999 HOLDER EMBIO LTD STERIS ISOMEDIX SERVICES TIANJIN TIANYAO PHARMACEUTICALS CO LTD CULTOR FOOD SCIENCE INC SUBJECT

4Q2012

PSEUDOEPHEDRINE HYDROCHLORIDE, USP, MANUFACTURED IN MAHARASHTRA, INDIA CONTRACT STERILIZATION FACILITY IN LIBERTYVILLE (SOUTH),IL PREDNISONE ACETATE, MANUFACTURED IN TIANJIN, CHINA MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN KOTKA, FINLAND LACTITOL MONOHYDRATE, MANUFACTURED IN THOMPSON, IL 19699 BLACK POLYETHYLENE, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA AND CARTERSVILLE, GA STAT-RITE E-1150-001, MANUFACTURED IN CLEVELAND, OHIO PODOPHYLLOTOXIN (CPH-86), MANUFACTURED IN COUVET, SWITZERLAND R-848 DRUG SUBSTANCE AND DRUG PRODUCT (ORAL), MANUFACTURED IN ST. PAUL, MN FLUVOXAMINE MALEATE CR CAPSULES, MANUFACTURED IN COUNTY WESTMEATH, IRELAND PACKAGING MATERIALS, MANUFACTURED IN NAPERVILLE, IL TERAZOSIN HCI DIHYDRATE, MANUFACTURED IN SHEVA, ISRAEL MAGNESIUM SULFATE HEPTAHYDRATE, USP (PARENTERAL GRADES), MANUFACTURED IN UTICA, IL MUPIROCIN FREE ACID AND MUPIROCIN CALCIUM, MANUFACTURED IN WORTHING, WEST SUSSEX, ENGLAND ESTROGENIC POWDERS, MANUFACTURED IN CHICAGO, ILLINOIS PENICILLIN V POTASSIUM, MANUFACTURED IN SLOVENSKA LUPCA, SLOVAKIA 100552-A AS POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA AND MESSANCY, BELGIUM BECLOMETHASONE DIPROPIONATE MONOHYDRATE, MANUFACTURED IN LERMA, EDO. MEXICO AMIDATING ENZYME, MANUFACTURED IN BOONTON, NEW JERSEY DOTA, MANUFACTURED IN MARANS, FRANCE FINAHENE 6006, MANUFACTURED IN ANTWERPEN, BELGIUM PLASDONE S-630, MANUFACTURED IN TEXAS CITY, TEXAS LACTITOL, DIRECTLY COMPRESSIBLE FORM,(FINLAC DC) MANUFACTURED IN THOMSON IL GANIRELIX, MANUFACTURED IN OSS, THE NETHERLANDS EQUILIN, USP, MANUFACTURED IN IXTACZOQUITLAN, VER.,MEXICO 110021 WHITE PE MB POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN, CARTERSVILLE, GA AND DEERIDDER, LA MANUFACTURING SITE, FACILTIES, PERSONNEL AND OPERATING PROCEDURES IN COPENHAGEN, DENMARK RENCYTE SYSTEM, MANUFACTURED IN COPENHAGEN, DENMARK NGVL/NONVIRAL GMP VECTOR PRODUCTION FACILITY IN ANN ARBOR, MI DEHYDROESTRONE, MANUFACTURED IN IXTACZOQUITLAN, VER. MEXICO ELTEX A5006FN1285, MANUFACTURED IN ROSIGNANO, ITALY

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4Q2012EXCEL DMF# 13979 13980 13981 13982 13983 13984 I 13985 13986 I 13987 13988 13989 13990 I 13991 13992 13993 A 13994 13995 13996 13997 13998 13999 14000 14001 14002 14003 A 14004 I 14005 A 14006 14007 I 14008 I 14009 I 14010 I II 3/4/1999 FARMABIOS SRL III 2/4/1999 AMPACET CORP IV 2/25/1999 I II II 3/8/1999 3/5/1999 II 3/1/1999 PRODUCTOS QUIMICOS NATURALES SA DE CV ORGANICHEM CORP CHONGQING DAXIN PHARMACEUTICAL CO LTD MCCORMICK AND CO INC II 2/26/1999 MALLINCKRODT INC A A A I I A I I A II II II III V II II IV IV III 2/19/1999 1/26/1999 1/26/1999 1/12/1999 2/24/1999 2/24/1999 2/23/1999 2/14/1999 2/14/1999 10/1/1998 I A II II II 2/23/1999 2/22/1999 2/19/1999 ALPS PHARMACEUTICAL IND CO LTD MOEHS IBERICA SL PRODUCTOS QUIMICOS NATURALES SA DE CV SAFC BIOSCIENCES INC AETERNA ZENTARIS GMBH AETERNA ZENTARIS GMBH BESPAK INC BIODOME PCAS NIPPON SHINYAKU CO LTD FONA INTERNATIONAL INC FONA INTERNATIONAL INC BORMIOLI ROCCO AND FIGLIO SPA I I I II II III I 2/17/1999 2/8/1999 2/11/1999 2/23/1999 MONACHEM CONTI BPC NVSA MICHELMAN INC ALPS PHARMACEUTICAL IND CO LTD A II II 2/17/1999 2/17/1999 LABORATOIRES BESINS INTERNATIONAL RP SCHERER CANADA INC STATUS Type SUBMIT DATE I I I I A II II III III II I 2/17/1999 2/10/1999 1/21/1999 1/21/1999 2/9/1999 2/19/1999 HOLDER MITSUBISHI TANABE PHARMA CORP KUNMING INSTITUTE OF BOTANY SOLVIN SA SOLVAY SA INDUSTRIALE CHIMICA SRL KOPALLE PHARMA CHEMICALS PVT LTD SUBJECT MCC-555, MANUFACTURED IN KASHIMA-GUN, IBARAKI-KEN, JAPAN PACLITAXEL (TAXOL) AS MANUFACTURED IN KUNMING, YUNNAN, CHINA IXAN PVDC PA 345, MANUFACTURED IN TAVAUX CEDEX, FRANCE IXAN PVDC PA 910, MANUFACTURED IN TAVAUX CEDEX, FRANCE PENTAZOCINE HYDROCHLORIDE, MANUFACTURED IN SARONNO,ITALY

4Q2012

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN HYDERABAD, INDIA ESTROGEL 0.06%, MANUFACTURED IN MONTROUGE, FRANCE ETOPOSIDE 50MG SOFT-GELATIN CAPSULE, MANUFACTURED IN WINDSOR, ONTARIO, CANADA NOMEGESTROL ACETATE, MANUFACTURED IN MC, MONACO MEMANTIME HCI, MANUFACTURED IN LANDED, BELGIUM MICHEM LUBE 160PFE, MANUFACTURED IN CINCINNATI, OH MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN GIFU PREF, JAPAN SENNOSIDES USP, MANUFACTURED IN GIFU PREF., JAPAN SOTALOL HCI, MANUFACTURED IN RUBI, SPAIN SODIUM 17 -ESTRADIOL SULFATE, MANUFACTURED IN IXTACZOQUITLAN, VER. MEXICO QBSF60 MEDIUM PRODUCT NO. 62520, MANUFACTURED IN DENVER, PENNSYLVANIA PERIFOSINE (D-21266), DRUG PRODUCT, MANUFACTURED IN BIELEFELD, GERMANY PERIFOSINE (D-21266), DRUG SUBSTANCE, MANUFACTURED IN RADEBEUL, GERMANY PHARMACEUTICAL ORAL INHALER, MANUFACTURED IN YOUNGSVILLE, NC BIO-SET INJECTION RCC & RCL, MANUFACTURED IN ISSOIRE CEDEX, FRANCE PRAZIQUANTEL, MANUFACTURED IN LIMAY, FRANCE NS-49, MANUFACTURED IN KYOTO, JAPAN 877.117 N-C NATURAL MINT FLAVOR (WONF), MANUFACTURED IN CAROL STREAM, IL 827.161 CINNAMON FLAVOR NATURAL, MANUFACTURED IN CAROL STREAM, IL GLASS CONTAINERS FOR PACKAGING FOR HUMAN DRUG AND BIOLOGICS, MANUFACTURED IN PARMA, BERGANTINO (RO), S. VITO AL TAGLIAMENTO (PN) & MONTERONI D'ARBIA (SI), ITALY PROPOXYPHENE HYDROCHLORIDE USP POWDER, MANUFACTURED IN ST. LOUIS, MISSOURI SODIUM-17 DIHYROEQUILIN SULFATE AS MANUFACTURED IN IXTACZOQUITLA VER MEXICO FLOXURIDINE, MANUFACTURED IN LINZ, AUSTRIA AMIKACIN HYDROCHLORIDE, NON-STERILE BULK DRUG, MANUFACTURED IN SICHUAN PROVINCE, CHINA MINT FLAVOR, NATURAL & ARTIFICIAL, WATER SOLUBLE, F55003, MANUFACTURED IN HUNT VALLEY, MD 110733 WHITE TALC POLYETHYLENE MASTERBATCH, MANUFACTURED IN TERRE HAUTE, IN, CARTERSVILLE, GA AND DERIDDER, LA CEFUROXIME, MANUFACTURED IN PAVIA, ITALY

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4Q2012EXCEL DMF# 14011 A 14012 14013 14014 14015 I 14016 14017 14018 A 14019 A 14020 A 14021 A 14022 I 14023 14024 14025 I 14026 I 14027 I 14028 I 14029 A 14030 A 14031 14032 14033 14034 14035 I 14036 14037 I 14038 I II 3/19/1999 LEO PHARMA AS A II II 3/16/1999 3/13/1999 DR REDDYS LABORATORIES LTD BACHEM CALIFORNIA A A I A IV II II II II 3/8/1999 3/10/1999 3/19/1999 3/19/1999 3/19/1999 SEPPIC SA TORAY INDUSTRIES INC SP PHARMACEUTICALS LLC NV ORGANON BASILDON CHEMICAL CO LTD III 3/17/1999 BORMIOLI ROCCO SPA BU PLASTICS III 3/17/1999 BORMIOLI ROCCO SPA BU PLASTICS II 3/18/1999 ALKERMES INC I 3/11/1999 PHARMACIA AND UPJOHN SPA II 3/9/1999 T HASEGAWA CO LTD A A II II V 3/9/1999 3/19/1999 3/12/1999 BOEHRINGER INGELHEIM CHEMICALS INC ZACH SYSTEM SPA NOVO NORDISK PHARMACEUTICAL INC II 3/1/1999 TAOKA CHEMICAL CO LTD III 2/20/1999 BORMIOLI ROCCO SPA BU PLASTICS III 2/20/1999 BORMIOLI ROCCO SPA BU PLASTICS III 2/20/1999 BORMIOLI ROCCO SPA BU PLASTICS I I IV IV III 3/11/1999 3/11/1999 2/20/1999 MANE MANE BORMIOLI ROCCO SPA BU PLASTICS I A A II II II IV 3/1/1999 3/5/1999 2/26/1999 3/11/1999 LABORATORIES ARGENOI SL CHEMI SPA BAYER PHARMA AG MANE INC STATUS Type SUBMIT DATE III 2/23/1999 HOLDER CANADA COLORS AND CHEMICALS LTD SUBJECT

4Q2012

ANTISTAT MB553-02 POLYPROPYLENE ADDITIVE CONCENTRATE, MANUFACTURED IN ONTARIO, CANADA METHOCARBAMOL, MAUFACTURED IN ZARAGOZA, SPAIN AICA.HCI, MANUFACTURED IN FROSINONE, ITALY DIENOGEST, MANUFACTURED IN BERKAMEN, BERLIN AND JENA, GERMANY NATURAL & ARTIFICIAL PEPPERMINT FLAVOR S.D. F93125, MANUFACTURED IN WAYNE, NJ NATURAL PEPPERMINT FLAVOR F93554, MANUFACTURED IN WAYNE, NJ NATURAL ANISE FLAVOR W.O.N.F. NY11599, MANUFACTURED IN WAYNE, NJ HDPE BOTTLE 180ML, MANUFACTURED IN CASTELGUELFO & RIVANAZZANO, ITALY AND SAINT SULPICE, FRANCE HDPE BOTTLE 105ML, MANUFACTURED IN CASTELGUELFO & RIVANAZZANO, ITALY AND SAINT SULPICE, FRANCE HDPE BOTTLE 70 ML, MANUFACTURED IN CASTELGUELFO & RIVANAZZANO, ITALY AND SAINT SULPICE, FRANCE CHILD PROOF CAP 35MM, MANUFACTURED IN CASTELGUELFO & RIVANAZZANO, ITALY AND SAINT SULPICE, FRANCE TRANS-4-ISOPROPYLCYCLOHEXANECARBONYL CHLORIDE AS MANUFACTURED IN OSAKA, JAPAN MILRINONE AS MANUFACTURED IN PETERSBURG VA GABAPENTIN AS MANUFACTURED IN VICENZA ITALY STERILIZATION PROCESS VALIDATION INFORMATION AT NOVO NORDISK PHARMACEUTICALS IN CLAYTON, NC TRANS-4-ISOPROPYLCYCLOHEXANECARBONYL CHLORIDE MANUFACTUREDIN SAITAMA PREFECTURE, JAPAN MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES, AND PERSONNEL OF THE GS/API PROCESS R&D PLANT IN NERVIANO, ITALY PROLEASE DILUENT USED FOR SUSPENSION OF PROLEASE MICROSPHERE PRODUCTS FOR PRODUCT ADMINISTRATION AS MANUFACTURED AT COOK PHARMACEUTICAL SOLUTIONS IN BLOOMINGTON IN HDPE BOTTLE 200 ML AS MANUFACTURED IN CASTELGUELFO ITALY RIVANAZZANO ITALY AND SAINT SULPICE FRANCE HDPE BOTTLE 125 ML AS MANUFACTURED IN CASTELGUELFO ITALY RIVANAZZANO ITALY AND SAINT SULPICE FRANCE SEPIFILM LP- COLORLESS RANGE (007,010, 014 AND 030) BERAPROST SODIUM AS MANUFACTURED IN SHIZUOKA JAPAN IMMTHER DRUG PRODUCT AS MANUFACTURED IN ALBUQUERQUE, NEW MEXICO NALOXONE HYDROCHLORIDE AS MANUFACTURED IN APELDOORN THE NETHERLANDS SIMETHICONE USP (BASILDON CHEMICALS SIMETHICONE ANTIFOAM C100F) AS MANUFACTURED IN OXON, GREAT BRITAIN NIZATIDINE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA GROWTH HORMONE RELEASING FACTOR (1-44), AMIDE, HUMAN, TRIFLUOROACETATE (BULK), MANUFACTURED IN SAN DIEGO AND TORRANCE, CALIFORNIA HEPARIN SODIUM DRUG SUBSTANCE AS MANUFACTURED IN ESBJERG DENMARK MIDDLESBROUGH UNITED KINGDOM AND CORK IRELAND

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4Q2012EXCEL DMF# 14039 14040 14041 A 14042 14043 14044 I 14045 14046 A 14047 14048 I 14049 I 14050 A 14051 14052 A 14053 14054 I 14055 14056 14057 I 14058 14059 14060 I 14061 A 14062 14063 14064 A 14065 I 14066 I 14067 A III 4/8/1999 3M DRUG DELIVERY SYSTEMS I 4/9/1999 II 4/7/1999 DEPA ILAC AKTIF MADDELERI SANAYI VE PAZARLAMA A S SPECIALTIES SEPTODONT I I II II III 4/12/1999 4/9/1999 4/12/1999 ML LABORATORIES UBE INDUSTRIES LTD MEDISIZE IRELAND LTD III 4/27/1999 WADDINGTON IP JAYCARE A I II II III 4/7/1999 4/5/1999 3/30/1999 RANBAXY LABORATORIES LTD ERREGIERRE SPA CANADA COLORS AND CHEMICALS LTD A A II II III 3/19/1999 4/5/1999 3/24/1999 WANBURY LTD VUAB PHARMA AS INGENIA POLYMERS CORP I III III 3/11/1999 3/7/1999 I IV IV 3/25/1999 3/18/1999 II 3/25/1999 II 3/29/1999 I II I 3/29/1999 3/29/1999 ERREGIERRE SPA TRAZODONE HYDROCHLORIDE AS MANUFACTURED IN BERGAMO, ITALY A II II 3/31/1999 3/31/1999 ISO TEX DIAGNOSTICS INC PADDOCK LABORATORIES LLC A I III III III 3/25/1999 3/2/1999 4/2/1999 BERRY PLASTICS CORPORATION FILLAB INC LOGOTECH INC STATUS Type SUBMIT DATE I A II II III 3/19/1999 3/11/1999 3/26/1999 HOLDER LEO PHARMA AS TEVA PHARMACEUTICAL INDUSTRIES LTD SHIOTANI GLASS CO LTD SUBJECT

4Q2012

HEPARINASE DRUG SUBSTANCE AS MANUFACTURED IN BALLERUP DENMARK MUPIROCIN AS MANUFACTURED IN DEBRECEN HUNGARY MANUFACTURING, INSPECTING, PACKAGING, LABELING, & STORING OF AMPULES, SYRINGES, AND OTHER SPECIAL CONTAINERS CLOSURES MANUFACTURED AT EVANSVILLE AND PRINCETON, INDIANA POLYVINYL CHLORIDE (PVC) SUPPOSITORY SHELLS LABEL STOCK, INK, AND VARNISH FOR PRINTING LABELS MANUFACTURED IN FAIRFIELD, NJ YTTRIUM-90 (Y-90) AS MANUFACTURED IN FRIENDSWOOD, TEXAS CONJUGATED ESTROGENS (F00022) (ESUB) AS MANUFACTURED IN CHICAGO, ILLINOIS

YUNG SHIN PHARMACEUTICAL INDUSTRIES MANUFACTURING FACILITY IN TAIWAN, CHINA FOR THE PRODUCTION OF LOVASTATIN CO LTD YUNG SHIN PHARMACEUTICAL INDUSTRIES LOVASTATIN AS MANUFACTURED IN TAIWAN, CHINA CO LTD SANYO FINE CO LTD HMMP [2-HYDROXYMETHYL-4-(3-METHOXYPROPOXY)-3-METHYLPYRIDINE] AS MANUFACTURED IN HYOGO PREFECTURE, JAPAN FONA INTERNATIONAL INC NATURAL AND ARTIFICIAL PEACH FLAVOR MOLKEREI MEGGLE WASSERBURG GMBH AND CO KG HENKEL KG AA RISDON SA MICROCELAC 100 AS MANUFACTURED IN WASSERBURG, GERMANY LOXIOL EP 728 AND 861 AS MANUFACTURED IN DUSSELDORF, GERMANY THERMOPLASTICS FOR THE MANUFACTURE OF EYE DROPPERS AND ACCESSORIES AS MADE IN OFFRANVILLE, FRANCE METFORMIN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTA, INDIA NYSTATIN USP AS MANUFACTURED IN VLTAVSKA, CZECH REPUBLIC WT170 WHITE FOR USE IN PACKAGING MATERIALS AS MANUFACTURED IN CALGARY, ALBERTA AND BRANTFORD, ONTARIO, CANADA CEFUROXIME AXETIL (CRYSTALLINE) AS MANUFACTURED IN PUNJAB INDIA OXAPROZIN JP AS MANUFACTURED IN BERGAMO, ITALY WHITE MB20922 POLYETHYLENE COLOR CONCENTRATE AS MANUFACTURED IN COLBORNE, ONTARIO DESIGNS MATERIALS AND SPECIFICATIONS FOR 60ML WHITE OPAQUE HDPE BOTTLE AS MANUFACTURED IN CARLSTADT NJ DEXTRIN SULPHATE AS MANUFACTURED IN LIVERPOOL ENGLAND 6,7-DIFLUOROACID FORM INTERMEDIATE AS MANUFACTURED IN YAMAGUCHI, JAPAN SADDLE PORT SYSTEM DESIGNED FOR USE IN MEDICAL FLUID CONTAINERS AS MANUFACTURED IN CO DONEGAL, REPUBLIC OF IRELAND CLAVULANATE POTASSIUM AS MANUFACTURED IN KOCAELI, TURKEY MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES, AND PERSONNEL AT SPECIALITIES SEPTODONT LOCATED IN SAINT MAURDES FOSSES, FRANCE COTRAN 9715, 9716, AND 9728 (19% ETHYLENE VINYL ACETATE (EVA) FILMS) MANUFACTURED IN BROOKINGS, SOUTH DAKOTA Page 411

4Q2012EXCEL DMF# 14068 A 14069 A 14070 14071 14072 14073 I 14074 14075 14076 I 14077 14078 14079 I 14080 I 14081 A 14082 14083 I 14084 A 14085 A 14086 A 14087 14088 A 14089 14090 14091 14092 I 14093 14094 I 14095 A III 3/1/1999 CANADA COLORS AND CHEMICALS LTD A II II 4/16/1999 4/23/1999 DISHMAN NETHERLANDS BV CHEMI SPA A I A II III II III 4/20/1999 4/21/1999 4/22/1999 4/6/1999 LONZA BIOTEC SRO HUMPHREY COSBURN PLASTICS ALBEMARLE CORP INTERGLASS INC A II II 4/17/1999 4/19/1999 IPCA LABORATORIES LTD CLARIANT GMBH II 4/19/1999 CATALENT PHARMA SOLUTIONS LLC III 4/12/1999 EXAL CORP III 4/19/1999 ZEON CORP A III III 4/23/1999 4/21/1999 BERRY PLASTICS CORP AMPACET CORP MARVELSEAL 360 PLAIN(UNPRINTED) AS MFG IN BERRY PLASTICS III 4/23/1999 II 4/9/1999 CLARIANT GMBH GRIESHEIM WORKS DIVISION FINE CHEMICALS ALGROUP LAWSON MARDON A A II II I 3/29/1999 4/8/1999 4/15/1999 GEDEON RICHTER PLC SICOR DE MEXICO SA DE CV PLIVA DD I I II II I 4/7/1999 3/22/1999 3/23/1999 RANBAXY LABORATORIES LTD WL GORE AND ASSOC INC STERITEK INC A I A II II II II 4/7/1999 3/30/1999 4/7/1999 4/7/1999 SAFC BIOSCIENCES INC JUZEN CHEMICAL CO LTD BAXTER HEALTHCARE CORP ML LABORATORIES III 4/8/1999 3M DRUG DELIVERY SYSTEMS STATUS Type SUBMIT DATE III 4/8/1999 HOLDER 3M DRUG DELIVERY SYSTEMS SUBJECT

4Q2012

COTRAN 9726 (2% ETHYLENE VINYL ACETATE (EVA) FILM) AS MANUFACTURED IN BROOKINGS, SOUTH DAKOTA COTRAN 9702, 9705, AND 9706 (9% ETHYLENE VINYL ACETATE (EVA) FILMS) AS MANUFACTURED IN BROOKINGS, SOUTH DAKOTA. EXCELL PF CHO AS MANUFACTURED IN DENVER, PENNSYLVANIA OXYBUTYNIN AS MANUFACTURED IN TOYAMA PREFECTURE, JAPAN ICODEXTRIN POWDER AS MANUFACTURED IN LIVERPOOL, ENGLAND 4% ICODEXTRIN SOLUTION AS MANUFACTURED IN LARNE CO, ANTRIM, NORTHERN IRELAND CEFUROXIME AXETIL AS MANUFACTURED IN PUNJAB, INDIA GORE PERISTALTIC PUMP TUBING AS MANUFACTURED IN ELKTON, MARYLAND MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES, MAJOR EQUIPMENT, AND KEY PERSONNEL FOR PACKAGING OF DRUG PRODUCTS IN MOONACHIE, NEW JERSEY. SPIRONOLACTONE AS MANUFACTURED IN BUDAPEST, HUNGARY CYPROTERONE ACETATE AS MANUFACTURED IN LERMA, EDO, MEXICO MANUFACTURING SITE, PERSONNEL, AND OPERATING PROCEDURES FOR AZITHROMYCIN DIHYDRATE AS MANUFACTURED IN PRIGOJE BRDOVECKO, CROATIA N-CARBOXYBENZYL-3-FLUORO-4-MORPHOLINOANILINE AS MANUFACTURED IN FRANKFURT AM MAIN, GERMANY LAMINATED ALUMINUM FOIL PACKAGES AS PRODUCED IN TORONTO, ONTARIO, CANADA

11989I WHITE PE POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE, IN, CARTERSVILLE, GA, DERIDDER, LA & MESSANCY, BELGIUM CYCLOOLEFIN POLYMER (ZEONEX 690 R) AS MANUFACTURED IN KURASHIKI, OKLAYAMA, JAPAN PACKAGING MATERIALS AEROSOL ALUMINUM CONTAINERS AS AMNUFACTURED IN YOUNGSTOWN OHIO TARGRETIN 75 MG SOFT-GELATIN CAPSULE AS MANUFACTURED IN ST PETERSBURG FL HYDROXYCHLOROQUINE SULFATE AS MANUFACTURED IN MADHYA PRADESH INDIA N-CARBOXYBENZYL-3-FLUORO-4-MORPHOLINOANILINE AS MANUFACTURED IN FRANKFURT GERMANY L-CARNITINE L-TARTATE AS MANUFACTURED IN KOURIM CZECH REPUBLIC PLASTIC APPLICATORS AS MANUFACTURED IN TORONTO CANADA 1LZD-LINEZOLID, STEP 1 AS MANUFACTURED IN SOUTH HAVEN MI TUBING GLASS CONTAINERS (AMPOULES & VIALS) AS MANUFACTURED IN WOODBRIDGE ONTARIO CANADA CALCITRIOL AS MANUFACTURED IN WEESP THE NETHERLANDS 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL AMMONIUM SALT AS MANUFACTURED IN PATRICIA ITALY ANTIBLOCK MB-155-13 POLYPROPYLENE ADDITIVE CONCENTRATE AS MANUFACTURED IN COLBORNE ONTARIO CANADA

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4Q2012EXCEL DMF# 14096 A 14097 14098 14099 14100 14101 14102 I 14103 A 14104 I 14105 14106 A 14107 I 14108 I 14109 14110 A 14111 14112 14113 14114 I 14115 I 14116 14117 I 14118 I 14119 I 14120 I 14121 A III 5/7/1999 AMPACET CORP III 5/7/1999 AMPACET CORP IV 3/15/1999 FONA INTERNATIONAL INC IV 3/15/1999 FONA INTERNATIONAL INC I IV IV 3/16/1999 3/23/1999 FONA INTERNATIONAL INC FONA INTERNATIONAL INC IV 3/16/1999 FONA INTERNATIONAL INC I I I IV IV IV IV 3/16/1999 3/25/1999 3/25/1999 3/25/1999 FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC A II III 5/10/1999 5/10/1999 EUTICALS SPA WEST PHARMACEUTICAL SERVICES INC III 2/23/1999 PECHINEY EMBALLAGE FLEXIBLE EUROPE III 2/23/1999 PECHINEY EMBALLAGE FLEXIBLE EUROPE I III III 5/3/1999 4/19/1999 HUNTSMAN POLYPROPYLENE CORP GERRESHEIMER GLASS INC III 4/24/1999 CLARIANT SPA (ITALIA) II 4/29/1999 H LUNDBECK AS I I A A I II III II II II III 5/3/1999 5/4/1999 5/3/1999 4/28/1999 4/30/1999 4/26/1999 AJINOMOTO CO INC WISTOFF GMBH & CO MEDICHEM SA YAMASA CORP EURO CHEMI INC DOW CHEMICAL CO STATUS Type SUBMIT DATE II 4/30/1999 HOLDER SAFC BIOSCIENCES INC SUBJECT

4Q2012

EX-CELL 525 FOR PER C6 CELLS, DEFINED SERUM FREE MEDIUM,AS MANUFACTURED IN DENVER PENNSYLVANIA AT-1015 A 5-HT2A ANTAGONIST AS MANUFACTURED IN MIE PREFECTURE JAPAN PHARMACEUTICAL GLASS CONTAINERS AS MANUFACTURED IN ESSEN GERMANY FELODIPINE AS MANUFACTURED IN CELRA SPAIN DIQUAFOSOL TETRASODIUM AS MANUFACTURED IN CHILBA-KEN JAPAN NIZATIDINE AS MANUFACTURED IN BARCELONA SPAIN POLYETHYLENE RESINS FOR PACKAGING AND MEDICAL APPLICATIONS AS MANUFACTURED IN QUEBEC & ONTARIO CANADA TOLEDO OH PHILADELPHIAPA ST LOUIS IL AND HOUSTON TX S-CITALOPRAM OXALATE AS MANUFACTURED IN NYKOBING SI DENMARK COPENHAGENVALBY DENMARK MIDDLESBROUGH ENGLAND AND VANDOEUVRE-LES-NANCY CEDEX FRANCE CUSTOM COLORING/ADDITIVE CONCENTRATES FOR USE IN PLASTIC PRODUCTS AND PACKAGING AS MFG IN MERATE ITALY POLYPROPYLENE PRODUCTS AS MANUFACTURED IN ODESSA TEXAS COMPOSITION PROPERTIES AND TREATMENT OF GLASSES USED FOR PARENTERAL DRUG CONTAINERS AS MFG IN CHICAGO HEIGHTS IL FOIL FOR PHARMACEUTICAL WHITE(ONE SIDE) BLISTERFOIL AS MANUFACTURED IN BRIGOUND FRANCE DIJON FRANCE BARCELONA SPAIN AND DARMSTADT GERMANY FOIL FOR PHARMACEUTICAL WHITE(BOTH SIDES) BLISTERFOIL WITH PHTALATES AS MFG IN BRIGOUND FRANCE DIJON FRANCE BARCELONA SPAIN AND DARMSTADT GERMANY 1-LZD AS MANUFACTURED IN ROZZANO ITALY ELASTOMERIC COMPONENTS ALTERNATIVE FORMULATION 4588/40 GRAY TO FORMULATION 1888 GRAY AS MANUFACTURED IN LIONVILLE PA 825.075 ARTIFICIAL WILD CHERRY FLAVOR AS MANUFACTURED IN CAROL STREAM IL 936.115 NATURAL BITTERING FLAVOR AS MANUFACUTRED IN CAROL STREAM IL EU 936.115 NATURAL BITTERING FLAVOR AS MANUFACTURED IN CAROL STREAM IL 942.001 N-C NATURAL & ARTIFICIAL DAIRY FLAVOR AS MANUFACTURED IN CAROL STREAM IL 915.356 ARTIFICIAL STRAWBERRY FLAVOR (FRESH TYPE) AS MANUFACTURED IN CAROL STREAM IL 918.004 SWEET AM (A NATURAL FLAVOR) AS MANUFACTURED IN CAROL STREAM IL 815.105 BUBBLEMINT FLAVOR (NATURAL AND ARTIFICIAL) AS MANUFACTURED IN CAROL STREAM IL 827.183 N-C CINNAMON FLAVOR NATURAL AND ARTIFICIAL AS MANUFACTURED IN CAROL STREAM ILLINOIS 827.182 N-C CINNAMON FLAVOR NATURAL AND ARTIFICIAL AS MANUFACTURED IN CAROL STREAM ILLINOIS 11134 WHITE PE MB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE INCARTERSVILLE GA AND DERIDDER LA 190405 BLACK PE MB POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE INCARTERSVILLE GAAND DERIDDER LA

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4Q2012EXCEL DMF# 14122 I 14123 I 14124 I 14125 I 14126 I 14127 I 14128 I 14129 14130 I 14131 I 14132 14133 14134 I 14135 I 14136 14137 14138 14139 A 14140 I 14141 A 14142 14143 14144 A 14145 I 14146 A 14147 I III 5/13/1999 AMPACET CORP III 5/17/1999 AMPACET CORP V 5/19/1999 PHARMACIA AND UPJOHN INC I A II III II 5/21/1999 5/14/1999 5/12/1999 SOLVAY PHARMA GMBH CO PLAST SRL BASF PHARMA EVIONNAZ SA CHOLECALCIFEROL AS MANUFACTURED IN WEESP THE NETHERLANDS PLASTIC CAPS MANUFACTURED IN BEVERA DI BARZAGO ITALY V 5/17/1999 II 5/12/1999 NATIONAL INSTITUTES HEALTH NATIONAL CANCER INSTITUTE DIV CANCER TREATMENT AND DIAGNOSIS DSM PHARMACEUTICALS INC A I A II II II III 5/12/1999 5/12/1999 5/10/1999 5/5/1999 FARMABIOS S P A FARMABIOS SRL DOW CHEMICAL CO RTP CO III 5/6/1999 AMPACET CORP I A II II III 5/1/1999 5/3/1999 5/6/1999 ALPS PHARMACEUTICAL IND CO LTD SANDOZ GMBH AMPACET CORP IV 5/7/1999 FONA INTERNATIONAL INC A II I 5/5/1999 4/30/1999 PERKINELMER PUBLIC STOCK CORPORATION OYJ III 5/7/1999 AMPACET CORP III 5/7/1999 AMPACET CORP III 5/7/1999 AMPACET CORP III 5/7/1999 AMPACET CORP III 5/7/1999 AMPACET CORP III 5/7/1999 AMPACET CORP STATUS Type SUBMIT DATE III 5/7/1999 HOLDER AMPACET CORP SUBJECT

4Q2012

10561 UV PE MB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE INCARTERSVILLE GAAND DERIDDER LA 19909-T BLACK PE MB POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE INCARTERSVILLE GAAND DERIDDER LA 190007-U BLACK PE MB POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE INCARTERSVILLE GAAND DERIDDER LA 11303 WHITE UV PE MB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE INCARTERSVILLE GAAND DERIDDER LA 10478-A UV PE MB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE INCARTERSVILLE GAAND DERIDDER LA 19909 BLACK PE MB POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE INCARTERSVILLE GAAND DERIDDER LA 11376 WHITE HDPE MB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE INCARTERSVILLE GAAND DERIDDER LA YTTRIUM-90 AS MANUFACTURED IN BOSTON MA DESCRIPTION OF FACILITIES PROCESS AND MATERIALS OF MFG PLANT LOCATED IN NURMIJARU FINLAND 825.450 CHERRY MINT ARTIFICIAL FLAVOR AS MANUFACTURED IN CAROL STREAM ILLINOIS SENNOSIDES(60) AS MANUFACTURED IN THE GIFU PREFECTURE JAPAN CEFAZOLIN SODIUM(STERILE)AS MANUFACTURED IN TYROL AUSTRIA 110532-I WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE INCARTERSVILLE GAAND DERIDDER LA 110674 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE INCARTERSVILLE GAAND DERIDDER LA FLUDROCORTISONE ACETATE AS MANUFACTURED IN PAVIA ITALY CEFUROXIME SODIUM STERILE AS MANUFACTURED IN PAVIA ITALY POLYMILL POLYSTYRENE MILLING MEDIA AS MANUFACTURED IN MIDLAND MICHIGAN THERMOPLASTIC COMPOUNDS FOR USE IN DRUG DELIVERY SYSTEMS AS MANUFACTURED IN WINONA MN PC-4 (SILICONE PHTHALOCYANINE) AS MANUFACTURED IN BUFFALO NY

STERILE PRODUCT OPERATION-NORTH (SPO-NORTH) IN GREENVILLE NORTH CAROLINA

PRILOCAINE BASE AS MANUFACTURED IN EVIONNAZ SWITZERLAND AND ST VULBAS FRANCE REFERENCE INFORMATION FOR NEW STERILE MFG. FACILITY IN KALAMAZOO MI REFERRED TO AS THE CENTER FOR ADVANCED STERILE TECHNOLOGY(CAST) 11070 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE INCARTERSVILLE GAAND DERIDDER LA 11898-IT WHITE PE MB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE IN CARTERSVILLE GAAND DERIDDER LA

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4Q2012EXCEL DMF# 14148 14149 14150 14151 14152 I 14153 14154 I 14155 14156 14157 14158 14159 I 14160 14161 14162 I 14163 I 14164 I 14165 I 14166 I 14167 A 14168 14169 14170 14171 I 14172 14173 14174 14175 14176 14177 I 14178 14179 I A III I 5/21/1999 5/25/1999 HEINKE TECHNOLOGY INC SANOCHEMIA PHARMAZEUTIKA AG I I I A I II II II IV III IV 5/31/1999 6/3/1999 6/4/1999 5/31/1999 5/24/1999 5/25/1999 A A A III II II II 6/3/1999 6/2/1999 6/1/1999 5/28/1999 MILLIKEN AND CO TARO PHARMACEUTICAL INDUSTRIES LTD IDT AUSTRALIA LTD SHANGHAI SHENLONG PHARMACEUTICAL CO LTD HAUPT PHARMA GMBH CILAG AG API INC LTP LIPID TECHNOLOGIES PROVIDER AB SOLVAY DRAKA INC. FONA INTERNATIONAL INC ' II 5/28/1999 MALLINCKRODT INC IV 3/18/1999 FONA INTERNATIONAL INC IV 3/18/1999 FONA INTERNATIONAL INC IV 3/18/1999 FONA INTERNATIONAL INC IV 3/18/1999 FONA INTERNATIONAL INC I I III III III 5/10/1999 5/10/1999 5/21/1999 POLIMERI EUROPA FRANCE SNC POLIMERI EUROPA FRANCE SA VERRETUBEX A I A A II II II III III 5/26/1999 5/28/1999 5/26/1999 5/14/1999 5/21/1999 ROLABO OUTSOURCING SL DAICEL CHEMICAL INDUSTRIES LTD ORGAPHARM BERRY PLASTICS CORP AKZO NOBLE INKS CORPORATION I II II 4/30/1999 5/25/1999 SILICONATURE SPA INDUSTRIALE CHIMICA SRL STATUS Type SUBMIT DATE A I I A II II II II I 5/20/1999 5/21/1999 5/21/1999 5/14/1999 3/18/1999 HOLDER PISGAH LABS INC SCHWIEZERHALL MFG CO SCHWIEZERHALL DEVELOPMENT CO TARO PHARMACEUTICAL INDUSTRIES LTD PENINSULA LABORATORIES INC SUBJECT DISODIUM PAMOATE AS MANUFACTURED IN PISGAH FOREST NC SULFABENZAMIDE AS MANUFACTURED IN GREENVILLE SC IMIPRAMINE PAMOATE AS MANUFACTURED IN GREENVILLE SC FLUOCINONIDE USP MICRONIZED AS MANUFACTURED IN HAIFA BAY ISRAEL MANUFACTURING SITE FACILITIES PROCEDURES & PERSONNEL FOR DRUG SUBSTANCES PRODUCED IN SAN CARLOS CA SILFLU MED MD07 AS MANUFACTURED IN GODEGA DI S URBANO ITALY

4Q2012

FORMOTEROL FUMARATE DIHYDRATE MICRONIZED AS MANUFACTURED IN SARRONO, ITALY. LORATADINE AS MANUFACTURED IN ZARAGOZA SPAIN FK614 DRUG SUBSTANCE AS MANUFACTURED IN NIIGATA JAPAN FENOFIBRATE DRUG SUBSTANCE AS MANUFACTURED IN PITHIVIERS FRANCE PRODUCT 41727-34 AS MANUFACTURED IN COLUMBUS, GA WATER BASED PRINTING INK PRODUCTS UV CURABLE PRINTING INK PRODUCTS AS MANUFACTURED IN PLYMOUTH MN FLEXIRENE FG20F AS MANUFACTURED IN DUNKIRK FRANCE FLEXIRENE FG23F AS MANUFACTURED IN DUNKIRK FRANCE AMPOULES VIALS CARTRIDGES AS MANUFACTURED IN NOGENT LE ROI AND CHALON SUR SAONE FRANCE 874.001 NOR CAP ART MELON FLAVOR AS MAUFACTURED IN CAROL STREAM ILLINOIS 852.035 N-C NATURAL AND ARTIFICIAL FLAVOR AS MANUFACTURED IN CAROL STREAM ILLINOIS 895.032 NOR CAP ARTIFICIAL PINNEAPPLE FLAVOR AS MANUFACTURED IN CAROL STREAM ILLINOIS 815.016 N-C BUBBLEGUM FLAVOR (A NATURAL AND ARTIFICIAL FLAVOR) AS MANUFACTURED IN CAROL STREAM ILLINOIS SODIUM PHOSPHATE MONOBASIC USP MONOHYDRATE GRANULAR FOOD GRADE (ESUB) AS MANUFACTURED IN ST LOUIS MO PC COLORANTS AS MANUFACTURED IN BLACKSBURG SOUTH CAROLINA CLORAZEPATE DIPOTASSIUM USP AS MANUFACTURED IN HAIFA BAY ISRAEL THIOTEPA USP AS MANUFACTURED IN BORONA VICTORIA AUSTRALIA AMIODARONE HYDROCHLORIDE AS MANUFACTURED IN SHANGHAI PEOPLES REPULIC OF CHINA L-CARNITINE CAPSULES 500MG AS MANUFACTURED IN WOLFRAHAUSEN GERMANY DOXAZOSIN MESYLATE AS MANUFACTURED IN SCHAFFHAUSEN SWITZERLAND NABUMETONE DRUG SUBSTANCE AS MANUFACTURED IN GUAYAMA PUERTO RICO CPL-GALACTOLIPID AS MANUFACTURED IN KARLSHAMN SWEDEN SOLMED WRAPFLEX 5000 AS MANUFACTURED IN FRESNO CALIFORNIA 915.236 N-C NATURAL STRAWBERRY FLAVOR(WONF) AS MANUFACTURED IN CAROL STREAM ILLINOIS PLASTIC CONTAINER AND APPLICATOR DEVICE AS MANUFACTURED IN LINCOLN NE FACILITIES PERSONEL AND GENERAL OPERATING PROCEDURES IN THE CHEMICAL PRODUCTION UNIT IN NEUFELD/LEITHA AUSTRIA

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4Q2012EXCEL DMF# 14180 I 14181 A 14182 14183 I 14184 A 14185 14186 14187 14188 14189 14190 14191 14192 14193 14194 A 14195 A 14196 14197 14198 14199 I 14200 14201 14202 14203 I 14204 14205 14206 A 14207 I 14208 14209 A 14210 14211 14212 A I I II II II 6/14/1999 4/22/1997 9/1/1980 A II II 6/14/1999 6/17/1999 AMRI RENSSELAER INC II 5/20/1999 KYOWA HAKKO KOGYO CO LTD A I II II III 6/11/1999 6/15/1999 6/8/1999 EUTICALS SPA SANKYO CO LTD WINPAK TECHNOLOGIES INC A I I II II II III 9/1/1998 6/14/1999 6/15/1999 6/7/1999 ABBVIE INC AJANTA PHARMA LTD SANKYO CO LTD HUNTSMAN POLYPROPYLENE CORP A A I II II III III 4/15/1999 4/14/1999 6/11/1999 6/14/1999 OMICRON QUIMICA SA OMICRON QUIMICA SA WINPAK HEAT SEAL PACKAGING MOBIL CHEMICAL CO II 6/7/1999 SIFAVITOR SRL A A C I I I I I I II III II III III III III III II IV 6/1/1999 6/7/1999 6/10/1999 5/26/1999 5/25/1999 5/24/1999 5/26/1999 5/26/1999 5/7/1999 6/9/1999 SHASUN PHARMACEUTICALS LTD MITSUBISHI PLASTICS IND LTD XELLIA PHARMACEUTICALS APS SOLVAY SA POLIMERI EUROPA SRL POLIMERI EUROPA FRANCE SA POLIMERI EUROPA FRANCE SA POLIMERI EUROPA FRANCE SA SALSBURY CHEMICALS INC BANNER PHARMACAPS INC II 5/28/1999 MALLINCKRODT INC I II II 6/1/1999 5/25/1999 II 5/28/1999 STATUS Type SUBMIT DATE II 5/28/1999 HOLDER NINGBO RENJIAN BIOCHEMICAL & PHARMACEUTICAL CO LTD HUNAN DONGTING PHARMACEUTICAL CO LTD HIKAL LTD BASIC VEGETABLE PRODUCTS SUBJECT

4Q2012

CHORIONIC GONADOTROPHIN AS MANUFACTURED IN CIXI NINGBO PEOPLES REPUBLIC OF CHINA TRANEXAMIC ACID AS MANUFACTURED IN THE HUNAN PROVINCE PEOPLES REPUBLIC OF CHINA PENTOXIFYLLINE AS MANUFACTURED IN BANGALORE INDIA NUTRACEUTICAL GARLIC PRODUCT A10000 AS MANUFACTURED IN KING CITY CALIFORNIA SODIUM PHOSPHATE DIBASIC USP POWDER (DRIED) (ESUB) AS MANUFACTURED IN ST LOUIS MO NAPROXEN SODIUM USP AS MANUFACTURED IN PONDICHERRY INDIA CASTING POLYPROPYLENE SHEET AS MANUFACTURED IN SHIGA PREFECTURE JAPAN POLYMYXIN B SULFATE (ESUB) AS MANUFACTURED IN COPENHAGEN DENMARK IXAN PA331 PVDC AS MANUFACTURED IN TAVUX CEDEX FRANCE RIBLENE FF34 AS MANUFACTURED IN GELA ITALY RIBLENE FC10 AS MANUFACTURED IN OBERHAUSEN DENMARK FLEXIRENE FG23U AS MANUFACTURED IN BRINDISI ITALY FLEXIRENE FG20U AS MANUFACTURED IN BRINDISI ITALY NICOTINE POLACRILEX RESIN AS MANUFACTURED IN CHARLES CITY IA GELATIN MASSES (SOFLET AND SOFTGEL FORMULATIONS) AS MANUFACTURED IN HIGH POINT NORTH CAROLINA LEVOBUNOLOL HYDROCHLORIDE AS MANUFACTURED IN FRAZIONE MAIRANO(LODI) ITALY BISMUTH SUBGALLATE AS MANUFACTURED IN BARCELONA SPAIN BISMUTH SUBNITRATE AS MANUFACTURED IN BARCELONA SPAIN FOILGUARD BF10V AS MANUFACTURED IN VAUDREUIL-DORION QUEBEC CANADA METALLIZED MULTILAYER POLYPROPYLENE FILM AS MANUFACTURED IN VIRTON BELGIUM AND DAYVILLE CONNECTICUT ERYTHROMYCIN BASE (ESUB) CEFADROXIL USP AS MFG IN MAHARASHTRA INDIA CS-780 DRUG SUBSTANCE AS MANUFACTURED IN KANAGAWA JAPAN POLYPROPYLENES PP23M2 23M2CS38 23M2CS198 23M2CS219 23M2CS260 23M10 23M10CS259 41E4CS215 AND 31S4CS62 AS MANUFACTURED IN ODESSA TEXAS DISOPYRAMIDE PHOSPHATE AS MANUFACTURED IN LODI ITALY CS-780 DRUG PRODUCT AS MANUFACTURED IN TOKYO JAPAN FLEXIBLE PACKAGING MATERIALS FOR VARIOUS PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN ONTARIO CANADA UBIDECARENONE BULK AS MANUFACTURED IN TAKASAGO-CITY HYOGO-PREFECTURE JAPAN PRALIDOXIME CHLORIDE AS MANUFACTURED IN RENSSELAER NY

UNION QUIMICO FARMACEUTICA SA UQUIFA KETOROLAC TROMETHAMINE USP AS MANUFACTURED IN BARCELONA SPAIN SA CADILA HEALTHCARE LTD ATENOLOL AS MANUFACTURED IN GUJARAT INDIA YUHAN CORP GLAXO PHARM CEFACLOR BULK AS MANUFACTURED IN SEOUL KOREA AMPICILLIN TRIHYDRATE

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4Q2012EXCEL DMF# 14213 14214 A 14215 A 14216 I 14217 I 14218 A 14219 I 14220 14221 I 14222 I 14223 I 14224 A 14225 I 14226 A 14227 I 14228 I 14229 14230 I 14231 14232 I 14233 I 14234 A 14235 A 14236 A 14237 A II 6/24/1999 SIFAVITOR SRL II 6/7/1999 II 6/24/1999 II 6/24/1999 III 6/18/1999 A III III 6/18/1999 6/18/1999 BERRY PLASTICS CORP BERRY PLASTICS CORP TAPES AND COATINGS DIV BERRY PLASTICS CORP TAPES AND COATINGS DIV CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD ROHNER LTD I IV IV 6/18/1999 6/18/1999 FONA INTERNATIONAL INC FONA INTERNATIONAL INC IV 6/2/1999 FONA INTERNATIONAL INC IV 6/2/1999 FONA INTERNATIONAL INC II 6/22/1999 EXCELLA GMBH III 6/21/1999 II 6/23/1999 SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTD AMPACET CORP I 6/18/1999 NINGXIA PHARMACEUTICAL FACTORY III 6/15/1999 POLYVEL INC I III III 6/21/1999 6/15/1999 AKERLUND AND RAUSING GROUP POLYVEL INC III 6/16/1999 AMPACET CORP III 6/16/1999 AMPACET CORP III 6/16/1999 AMPACET CORP III 6/16/1999 AMPACET CORP III 6/16/1999 AMPACET CORP STATUS Type SUBMIT DATE I II III 4/5/1990 3/24/1999 HOLDER BRISTOL MYERS SQUIBB COMPANY AMPACET CORP SUBJECT HETACILLIN POTASSIUM AS MANUFACTURED IN PUERTO RICO

4Q2012

16180 BLUE PE MB POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE IN DERIDDER LA AND CARTERSVILLE GA 7188335 WHITE POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE IN DERIDDER LA AND CARTERSVILLE GA 7182482 PEARLESCENT POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE IN DERIDDER LA AND CARTERSVILLE GA 7188680 WHITE POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE IN DERIDDER LA AND CARTERSVILLE GA 7188338 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE IN DERIDDER LA AND CARTERSVILLE GA 7180674 WHITE POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE IN DERIDDER LA AND CARTERSVILLE GA TRANSOFOIL LL-OPET/PE LAMINATE AS MANUFACTURED IN LUND SWEDEN ANTISTAIC ADDITIVE CONCENTRATE USED IN THE MFG OF FLEXIBLE CONTAINMENT DEVICES ANTIBLOCK ADDITIVE CONCENTRATE ASED IN THE MFG OF FLEXIBLE CONTAINMENT DEVICES MANUFACTURING SITES FACILITIES OPERATION PROCEDURES AND PERSONNEL IN YINCHUAN CITY NINGXIA HUI NATIONALITY AUTONOMOUS REGION PEOPLES REPUBLIC OF CHINA SULFAMETHAZINE SODIUM AS MANUFACTURED IN SHANGHAI CHINA 13920 YELLOW PE MB POLYETHYLENE MASTERBACH AS MANUFACTURED IN TERRE HAUTE INDERIDDER LA ANDCARTERSVILLE GA HALOPERIDOL (ESUB) AS MANUFACTURED IN FEUCHT GERMANY 915.354 N-C ARTIFICIAL STRAWBERRY FLAVOR AS MANUFACTURED IN CAROL STREAM ILLINOIS 831.002 N-C ARTIFICIAL PINA COLADA FLAVOR AS MANUFACTURED IN CAROL STREAM ILLINOIS 825.476 ARTIFICIAL CHERRY FLAVOR 826.229 NATURAL AND ARTIFICIAL CHOCOLATE FLAVOR AS MANUFACTURED IN CAROL STREAM ILLINOIS PRODUCT 24-5-067 AS MANUFACTURED IN HOMER, LA 48 GAUGE PET FILM/MICA A-131-X/12# WHITE PE/0.00030 FOIL/MICA A-291/1.5 MIL LLDPE HI (VF-58) AS MANUFACTURED IN HOMER LA 30# BLEACHED COATED ONE SIDE KRAFT PAPER/8# LDPE/0.00030 FOIL/MICA A-291/22# LLDPE (VF-50) AS MANUFACTURED IN HOMER LA GUAIFENESIN USP AS MANUFACTURED IN TAIWAN PRC PRAVASTATIN SODIUM USP AS MANUFACTURED IN TAIWAN PRC 4-AMINO-5-CHLORO2,1,3-BENZOTHIADIAZOLE DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN PRATTELN SWITZERLAND ECONAZOLE AS MANUFACTURED IN LODI ITALY

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4Q2012EXCEL DMF# 14238 14239 14240 14241 14242 14243 I 14244 A 14245 I 14246 14247 14248 I 14249 14250 14251 I 14252 14253 A 14254 14255 14256 I 14257 14258 A 14259 A 14260 14261 I 14262 14263 A 14264 I 14265 I 14266 14267 14268 I A I II II III 6/29/1999 7/6/1999 7/6/1999 J K DRUGS AND PHARMACEUTICALS LTD NV ORGANON HUMPHREY COSBURN PLASTICS III 6/30/1999 TRANSFOBEL PLASTICS NV I 6/29/1999 CADILA PHARMACEUTICALS LTD A III III 6/25/1999 6/29/1999 LAGEEN TUBOBLAST LTD PERLOS OYJ CEP PLASTICS NURMIJARVI I II III 7/3/1995 6/30/1999 II 6/25/1999 I II II 6/28/1999 6/25/1999 A A III II II 6/30/1999 5/25/1999 6/29/1999 ISHIDA PRESS KOGYO CO LTD CARLSON FILTRATION LTD RHODIA INDUSTRIE CHIMIQUE MULHOUSE DORNACH HOSPIRA INC BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG BIOCHEMICA OPOS SPA ZIMMER CUSTOM-MADE PACKAGING ALUMINUM CAPS FOR MEDICAL VIALS AS MANUFACTURED IN SAITAMA JAPAN I II II 6/30/1999 6/29/1999 PHIBRO ANIMAL HEALTH CORP CADILA PHARMACEUTICALS LTD A A II II III 6/14/1999 5/26/1999 6/23/1999 SAFC BIOSCIENCES INC ECOLAB INC ASTRA PLASTIQUE I N I 5/25/1999 II 7/6/1999 II 7/1/1999 II 7/1/1999 STATUS Type SUBMIT DATE I A A A I II II II II II II 6/28/1999 6/25/1999 6/25/1999 6/25/1999 6/29/1999 7/1/1999 HOLDER ASUBIO PHARMA CO LTD PHARMASYNTHESE RANBAXY LABORATORIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD MITSUBISHI TANABE PHARMA CORP COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARL COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARL COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARL LEO LABORATORIES LTD NOT AN ASSIGNED NUMBER MEDIBRANDS LTD SUBJECT CARPERITIDE DRUG SUBSTANCE AS MANUFACTURED IN GUNMA JAPAN 4 HYDROXYTAMOXIFEN AS MANUFACTURED IN EVRY CEDEX FRANCE OFLOXACIN USP AS MANUFACTURED IN PUNJAB INDIA

4Q2012

NORGESTIMATE BULK DRUG SUBSTANCE AS MANUFACTURED IN MILAN ITALY MKC-242 BULK DRUG SUBSTANCE AS MANUFACTURED IN IBARAKI-KEN JAPAN TETRACYCLINE PHOSPHATE AS MANUFACTURED IN ALENQUER, PORTUGAL DEMECLOCYCLINE HCL AS MANUFACTURED IN ALENQUER PORTUGAL ERYTHROMYCIN STEARATE AS MANUFACTUREDIN ALENQUER PORTUGAL AMDINOCILLIN PIVOXIL HCL MFG SITE FACILITIES OPERATING PROCEDURES AND PERSONNEL FOR MEDIBRANDS LTD. IN HAIFA ISRAEL EX-CELL PF CHO MEDIUM(MODIFIED) AS MANUFACTURED IN DENVER PENNSYLVANIA 20% CHLORHEXIDINE GLUCONATE AS MANUFACTURED IN HUNTINGTON IN CONTAINER CLOSURES(CAPS) MFG FROM THERMO PLASTIC MATERIAL AS MANUFACTURED IN SAINT GEORGES DE RENEINS FRANCE POTASSIUM NITRATE USP AS MANUFACTURED IN NARUTO JAPAN FLUOXETINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA

ASBESTOS FREE DEPTH FILTER SHEETS AS MANUFACTURED INLANCASHIRE UK LEVOTHYROXINE SODIUM USP AS MANUFACTURED IN MULHOUSSE FRANCE ROGOSIN EMULSION AS MANUFACTURED IN CLAYTON NC ALBUTEROL SULFATE (UNMICRONIZED) AS MANUFACTURED IN INGLHEIM AM RHEIN, GERMANY IPRATROPIUM BROMIDE MONOHYDRATE AS MANUFACTURED IN INGLEHEIM AM RHEIN, GERMANY CLINDAMYCIN HYDROCHLORIDE AS MANUFACTURED IN MILAN ITALY MOBIL OPPALYTE 35MU842/COMMEX CX1102 FILM LAMINATE AS MANUFACTURED IN INDIANAPOLIS INDIANA PLASTIC TUBES AND CAPS AS MFG IN KIBBUTZ YAGUR, ISRAEL TROCAR PACKAGING MATERIAL FOR SUBCUTANEOUS IMPLANTS AS MANUFACTURED IN NURMIJARVI FINLAND MFG SITE FACILITIES PROCEDURES AND PERSONEL FOR ANKLESHWAR SITE IN GUJARATINDIA POLYPROPYLENE SCREWCAPS FOR LOCKING ALUMINUM TUBES AS MANUFACTURED IN BRUSSELS BELGIUM CEPHALEXIN USP AS MANUFACTURED IN UTTAR PRADESH INDIA EPTIFIBATIDE AS MANUFACTURED IN THE NETHERLANDS ELDER-FRIENDLY CAPS AS MANUFACTURED IN TORONTO ONTARIO CANADA

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4Q2012EXCEL DMF# 14269 14270 I 14271 I 14272 A 14273 14274 14275 I 14276 14277 14278 14279 14280 14281 I 14282 I 14283 A 14284 14285 A 14286 14287 14288 14289 14290 A 14291 A 14292 A 14293 14294 14295 14296 A 14297 14298 14299 A I I II II III 7/9/1999 7/16/1999 10/18/1999 A A A III II II III 7/8/1999 6/30/1999 7/14/1999 5/28/1999 PROMENS MEDICAL PACKAGING AS CORN PRODUCTS INTERNATIONAL INC RANBAXY LABORATORIES LTD PHARMA GLAS GMBH KONIAKOWSKY AND KUEHR ERREGIERRE SPA CHEM SOURCE CORP RHODIA FILTEC INDUSTRIAL YARNS III 7/14/1999 3M DRUG DELIVERY SYSTEMS III 7/14/1999 3M DRUG DELIVERY SYSTEMS I I I I II II II II III 7/7/1999 7/12/1999 7/12/1999 7/12/1999 7/14/1999 WOCKHARDT LTD FUJISAWA PHARMACEUTICAL CO LTD HOECHST MARION ROUSSEL WOCKHARDT LTD 3M DRUG DELIVERY SYSTEMS OMEPRAZOLE AS MANUFACTURED IN ANKLESHWAR INDIA NILVADIPINE AS MANUFACTURED IN OSAKA JAPAN A II II 6/30/1999 6/30/1999 MALLINCKRODT LLC MALLINCKRODT INC II 7/12/1999 NV ORGANON II 7/7/1999 A A A A A III III III II III II 6/23/1999 7/6/1999 7/6/1999 7/9/1999 7/7/1999 7/9/1999 DANAPAK FLEXIBLES AS MICA CORP MICA CORP TEVA PHARMACEUTICAL INDUSTRIES LTD ALFATHERM SPA PHARMACEUTICAL FINE CHEMICALS BAHAMAS LTD RANBAXY LABORATORIES LTD N I II III 7/8/1999 7/6/1999 NOT AN ASSIGNED NUMBER BRISTOL MYERS SQUIBB COMPANY TUBES SOUPLES NV IV 6/15/1999 SHIN ETSU CHEMICAL CO LTD II 6/30/1999 ONO PHARMACEUTICAL CO LTD STATUS Type SUBMIT DATE A II IV 7/6/1999 6/28/1999 HOLDER EUTICALS SPA FONA INTERNATIONAL INC SUBJECT MECAMYLAMINE HYDROCHLORIDE AS AMNUFACTURED IN MILAN ITALY

4Q2012

877.170 N-C MINT FLAVOR NATURAL AND ARTIFICIAL AS MANUFACTURED IN CAROL STREAM ILLINOIS ONO-2506 DRUG SUBSTANCE AS MANUFACTURED IN KAISHIAI FUKAYA SAITAMA JAPAN SHIN-ETSU AQOAT (HYPROMELLOSE ACETATE SUCCINATE) MANUFACTURED IN NIIGATA JAPAN

AMPHOTERICIN NON PARENTAL GRADE AS MANUFACTURED IN HUMACO PUERTO RICO ALUMINUM COLLAPSIBLE TUBES AS PACKAGING MATERIAL AS MANUFACTURED IN TERNA BELGIUM KISI VERBUND PACKAGING MATERIAL AS MANUFACTURED IN SLAELSE DENMARK A-131-X AS MANUFACTURED IN SHELTON CONNETICUT A-251-A AS MANUFACTURED IN SHELTON CONNETICUT NEFAZODON HYDROCHLORIDE AS MANUFACTURED IN BE'ER SHEVA ISRAEL ALFAFORM K122 AS MANUFACTURED IN VARESE ITALY DOXAZOSIN MESYLATE AS MANUFACTURED IN FREEPORT GRAND BAHAMA ISLAND BAHAMAS AMMONIUM SALT OF MEVINOLINIC ACID AS MANUFACTURED IN HIMACHAL PRADESH INDIA DEHYDROISOANDROSTERONE POLYMORPH I AS MANUFACTURED IN OSS THE NETHERLANDS FENTANYL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ST. LOUIS MISSOURI FENTANYL ALKALOID (ESUB) AS MANUFACTURED IN ST LOUIS MISSOURI

LEVONORGESTREL AS MANUFACTURED IN ROMAINVILLE AND VERTOLAYE FRANCE FLUOXETINE HYDROCHLORIDE AS MANUFACTURED IN ANKLESHWAR INDIA 2-MIL POLYESTER FILM LAMINATE SCOTCHPAK 9732 AS MANUFACTURED IN COTTAGE GROVE MN 2MIL POLYESTER FILM LAMINATE SCOTCHPAK 9733 AS MANUFACTURED IN COTTAGE GROVE MN 2MIL POLYESTER FILM LAMINATE SCOTCHPAK 9735 AS MANUFACTURED IN COTTAGE GROVE MN POLYPROPYLENE VIALS AS MANUFACTURED IN LANGESKOV DENMARK ANHYDROUS DEXTROSE USP AS MANUFACTURED IN BEDFORD PARK IL DOXYCYCLINE USP AS MANUFACTURED IN PUNJAB INDIA PACKAGING MATERIAL AMPOULES MADE OF TUBULAR GLASS AS MANUFACTURED IN SALBURG AUSTRIA GEPIRONE HYDROCHLORIDE AS MANUFACTURED IN BERGAMO ITALY ETODOLAC DRUG SUBSTANCE AS MANUFACTURED IN GUAYAMA PUERTO RICO POLYESTER GRANULAT 74K40 AS MFG IN EMMENBRUKE SWITZERLAND

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4Q2012EXCEL DMF# 14300 14301 I 14302 I 14303 14304 14305 I 14306 I 14307 A 14308 14309 14310 14311 A 14312 14313 A 14314 14315 14316 I 14317 14318 14319 14320 14321 14322 A 14323 I 14324 14325 I 14326 I 14327 14328 I 14329 I IV 8/3/1999 FONA INTERNATIONAL INC I II IV 8/2/1999 8/3/1999 SUMIKA FINE CHEMICALS CO LTD FONA INTERNATIONAL INC SNK-860 AS MANUFACTURED IN OSAKA CITY JAPAN IV 8/2/1999 FONA INTERNATIONAL INC A II II 7/29/1999 7/28/1999 COSMA SPA SEITZ FILTER WERKE II 7/25/1999 LIFEHEALTH LIMITED I A A A A II II II II II II 7/28/1999 7/28/1999 7/1/1999 7/29/1999 7/29/1999 7/15/1999 BAYER CORP PHARMACEUTICAL DIV 3M DRUG DELIVERY SYSTEMS FARMHISPANIA SA DAIICHI SANKYO CO LTD DAIICHI SANKYO CO LTD NUSIL TECHNOLOGY LLC N I II II 7/1/1998 7/29/1999 NOT AN ASSIGNED NUMBER NORTH CHINA PHARMACEUTICAL CORP JIANGSU HENGRUI MEDICINE CO LTD I III III 7/16/1999 7/22/1999 I A A II II III II 7/22/1999 7/22/1999 7/16/1999 7/22/1999 J K DRUGS AND PHARMACEUTICALS LTD DR REDDYS LABORATORIES LTD STOELZE OBERGLAS GMBH ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD HEINKE TECHNOLOGY INC LANXESS DEUTSCHLAND GMBH II 7/16/1999 SAFC BIOSCIENCES INC IV 7/22/1999 FLAVORS NORTH AMERICA INC A A II II IV 7/14/1999 7/21/1999 7/22/1999 NTP RADIOISOTOPES LTD MOEHS IBERICA SL FONA INTERNATIONAL INC IODINE-131 (FISSION) AS MANUFACTURED IN PRETORIA SOUTH AFRICA ACETYLCYSTEINE USP AS MANUFACTURED IN RUBI SPAIN IV 7/19/1999 FONA INTERNATIONAL INC STATUS Type SUBMIT DATE I III IV 7/19/1999 7/19/1999 HOLDER RXI PLASTICS INC FONA INTERNATIONAL INC SUBJECT

4Q2012

POLYETHYLENE CONTAINERS AND CLOSURES AS MANUFACTURED IN OTTAWA OHIO 937.108 MASKING AGENT (A NATURAL FLAVOR) AS MANUFACTURED IN CAROL STREAM IL 937.106 NATURAL FLAVOR FOR MOUTHFEEL AS MANUFACTURED IN CAROL STREAM IL

884.064N-C NATURAL AND ARTIFICIAL ORANGE FLAVOR AS MANUFACTURED IN CAROL STREAM ILLINOIS 805.018 N-C ARTIFICIAL BANANA FLAVOR AS MANUFACTURED IN CAROL STREAM ILLINOIS EX-CELL PF CHO MEDIUM (MODIFIED) DEFINED SERUM-FREE MEDIUM AS MANUFACTURED IN DENVER PENNSYLVANIA CEFADROXIL MONOHYDRATE AS MANUFACTURED IN UTTAR PRADESH INDIA FAMOTIDINE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA GLASS PRIMARY PACKAGING AS MANUFACTURED INKOFLACH AUSTRIA CAPTOPRIL USP AS MANUFACTURED IN ZHEJIANG PEOPLES REPUBLIC OF CHINA VAGINAL FOAM APPLICATORS AS MANUFACTURED IN LINCOLN NE LEVAPREN 500 HV (ETHYLENE AMD VINYL COPOLYMER) AS MANUFACTURED IN DORMAGEN, GERMANY CYCLOSPORINE, USP (NON STERILE BULK)AS MANUFACTURED IN SHIJIAZHUANG PRC THIOTEPA USP NON STERILE BULK DRUG AS MANUFACTURED IN JIANGSU PROVINCE PRC CIPROFLOXACIN OD AS MANUFACTURED IN WUPPERTAL AND LEVERKUSEN GERMANY CI-1017 TRANSDERMAL DELIVERY SYSTEM AS MANUFACTURED IN ST PAUL MN ML-107 AS MANUFACTURED IN BARCELONA SPAIN CS-011 DRUG SUBSTANCE AS MANUFACTURED IN KANAGAWA JAPAN CS-011 DRUG PRODUCT AS MANUFACTURED IN TOKYO JAPAN SENTRY SIMETHICONE USP & SENTRY SIMETHICONE USP FORMULATIONS AS MANUFACTURED IN FRIENDLY WVA AND DACULA GA NITOMAN (TETRABENAZINE) TABLETS AS MANUFACTURED IN NEWCASTLE-UPON-TYNE UNITED KINGDOM METOPROLOL TARTRATE (ESUB) AS MANUFACTURED IN BERGAMO ITALY SEITZ DEPTH FILTER MEDIA AS MANUFACTURED IN BAD KREUZNACH FEDERAL REPUBLIC OF GERMANY 918.003 SWEET AM (AN ARTIFICIAL FLAVOR ) AS MANUFACTURED IN CAROL STREAM IL

906.265 N-C ARTIFICIAL RASPBERRY FLAVOR AS MANUFACTURED IN CAROL STREAM IL 913.047 DEEP GREEN SPEARMINT FLAVOR NATURAL(WONF) AS MANUFACTURED IN CAROL STREAM IL

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4Q2012EXCEL DMF# 14330 I 14331 I 14332 I 14333 I 14334 14335 A 14336 14337 14338 14339 14340 14341 14342 I 14343 I 14344 I 14345 I 14346 14347 I 14348 14349 14350 14351 I 14352 A 14353 14354 14355 A 14356 14357 14358 14359 A I I A III III III III 8/23/1999 8/2/1999 8/18/1999 8/20/1999 A I II II II 8/14/1999 8/16/1999 6/22/1999 PIRAMAL HEALTHCARE LTD JAPAN TOBACCO INC ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD SABIC PETROCHEMICALS BV C AND H PACKAGING CO INC MICA CORP TOKAI CHEMICAL INDUSTRY CO LTD IBUPROFEN AS MANUFACTURED IN ANDHRA PRADESH INDIA JTT-501 DRUG SUBSTANCE AS MANUFACTURED IN OSAKA JAPAN II 8/19/1999 I A I III II II II 7/27/1999 8/3/1999 8/18/1999 8/19/1999 RAYVEN INC ESSENTIAL PHYTOSTEROLINS INC NAPRO BIOTHERAPEUTICS, INC. TECHNOLOGY COMMERCIALIZATION INTERNATIONAL INC CIPLA LTD A II II 8/3/1999 8/13/1999 DISHMAN NETHERLANDS BV LIPOID GMBH IV 8/12/1999 FONA INTERNATIONAL INC IV 8/12/1999 FONA INTERNATIONAL INC IV 8/12/1999 FONA INTERNATIONAL INC A A A I I A II II II II II II IV 8/6/1999 7/28/1999 8/4/1999 8/10/1999 8/9/1999 8/4/1999 8/12/1999 PARTICLE DYNAMICS INTERNATIONAL LLC LUSOCHIMICA SPA SAMYANG GENEXBIO CORP USV LTD DIVIS LABORATORIES LTD ERCROS SA FONA INTERNATIONAL INC A II II 8/6/1999 8/6/1999 II 6/22/1999 SHIJIAZHUANG PHARMACEUTICAL GROUP CO LTD CIPLA LTD KATWIJK CHEMIE BV IV 8/3/1999 FONA INTERNATIONAL INC IV 8/3/1999 FONA INTERNATIONAL INC STATUS Type SUBMIT DATE IV 8/3/1999 HOLDER FONA INTERNATIONAL INC SUBJECT

4Q2012

913.048 SWEET GREEN SPEARMINT FLAVOR NATURAL AND ARTIFICIAL AS MANUFACTURED IN CAROL STREAM IL 913.049 WINTERMINT (A NATURAL FLAVOR) AS MANUFACTURED IN CAROL STREAM IL 935.094 ORIENTAL SPICEMINT FLAVOR NATURAL & ARTIFICIAL AS MANUFACTURED IN CAROL STREAM IL TRAMADOL HYDROCHLORIDE USP (BULK) AS MANUFACTURED IN SHIJIAZHUANG HEBEI CHINA ALENDRONATE SODIUM USP (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA 1,2-DIMETHYL-3-HYDROXY-PYRIDONE-4(DEFERIPONE) AS MANUFACTURED IN KATWIJK THE NETHERLANDS IBUPROFEN 70% AS MANUFACTURED IN ST LOUIS MO NISOLDIPINE AS MANUFACTURED IN LOMAGNA ITALY GENEXOL AS MANUFACTURED IN TAEJON KOREA GLYBURIDE AS MANUFACTURED IN MAHARASHTRA INDIA KETOROLAC ACID AS MANUFACTURED IN ANDHRA PRADESH INDIA FOSFOMYCIN SODIUM AS MANUFACTURED IN MADRID SPAIN 852.114 N-C NATURAL PUNCH FLAVOR(HAWAIIAN TYPE) AS MANUFACTURED IN CAROL STREAM IL 865.001 N-C NATURAL LIME FLAVOR (WONF) AS MANUFACTURED IN CAROL STREAM IL 894.068 N-C NATURAL PEPPERMINT FLAVOR(WONF) AS MANUFACTURED IN CAROL STREAM 921.002 NOR-CAP NATURAL TANGERINE FLAVOR(WONF) AS MANUFACTURED IN CAROL STREAM IL CHOLESTEROL HP AS MANUFACTURED IN VEENENDAAL THE NETHERLANDS LIPOID TRIOLEIN AS MANUFACTURED IN LUDWIGSHAFEN FEDERAL REPUBLIC OF GERMANY SILICONE COATED POLYESTER RELEASE LINER AS MANUFACTURED IN ST PAUL MN STERINOL AS MANUFACTURED IN MIDRAND SOUTH AFRICA PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN BOULDER COLORADO MOLYBDENUM-99 OF U-235 (N,F) AS MANUFACTURED IN MOSCOW RUSSIA PRAZIQUANTEL USP (ESUB) AS MANUFACTURED IN BANGALORE & MAHARASHTRA INDIA

ENALAPRIL MALEATE USP AS MANUFACTURED IN LINHAI CITY ZHEJIANG PROVINCE CHINA SABIC LDPE 2101TN00 AS MANUFACTURED IN BEEK THE NETHERLANDS UNIDOSE DRUG PACKAGING MATERIAL AS MANUFACTURED IN MERRILL WI MICA G-1092 AS MANUFACTURED IN SHELTON CONN DESSICANT TYPE PACKAGING MATERIALS AS MANUFACTURED IN AICHI AND TOCHIGI PREFECTURES JAPAN

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4Q2012EXCEL DMF# 14360 14361 A 14362 14363 14364 14365 A 14366 14367 14368 A 14369 14370 14371 14372 14373 14374 14375 14376 A 14377 14378 14379 14380 14381 14382 14383 14384 I 14385 14386 I 14387 I 14388 A 14389 14390 14391 14392 14393 A I A A A II II II III II 8/26/1999 9/7/1999 9/7/1999 9/6/1999 9/10/1999 CHROMADEX INC TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD MEDISIZE CORP TOYAMA CHEMICAL CO LTD IV 9/7/1999 AARHUSKARLSHAMN AB IV 9/1/1999 FONA INTERNATIONAL INC I II II 8/31/1999 8/30/1999 A A I I I I I III III III II III II II II 8/31/1999 8/31/1999 8/23/1999 8/4/1999 8/25/1999 9/2/1999 8/31/1999 8/31/1999 POLYONE CORP POLYONE CORP ROHM AND HAAS CO MERCK KGAA CARCANO ANTONIO S.P.A. DIOSYNTH BV HARLAN BIOSCIENCE FOR SCIENCE INC SATO PHARMACEUTICAL RESEARCH INSTITUTE INC NEOMPS INC NINGXIA PHARMACEUTICAL FACTORY I I I A I A A III II II II II II II III 8/25/1999 8/30/1999 8/30/1999 8/30/1999 8/26/1999 8/30/1999 8/31/1999 7/9/1999 CONTINENTALAFA DISPENSING CO GRANULES INDIA LTD GRANULES INDIA LTD GRANULES INDIA LTD SIOUX PHARM INC TARO PHARMACEUTICAL INDUSTRIES LTD ALBEMARLE CORP ECLATIN AG I A II II V 8/19/1999 8/25/1999 8/30/1999 I I A II II V II 8/24/1999 8/20/1999 8/9/1999 8/16/1999 BACHEM INC ZONAGEN INC CYDEX PHARMACEUTICALS INC JOHNSON MATTHEY PHARMACEUTICAL MATERIALS MEDICHEM SA ACS DOBFAR SPA CANGENE BIOPHARMA INC STATUS Type SUBMIT DATE A V III 8/9/1999 8/24/1999 HOLDER JANSSEN DIAGNOSTICS BVBA STYROLUTION AMERICA LLC SUBJECT

4Q2012

GENOTYPIC RESISTANCE TESTING FOR HIV AS DEVELOPED IN MECHELEN BELGIUM STYRENE METHYL METHACRYLATE COPOLYMER RESIN NAS30 AS MANUFACTURED IN INDIAN ORCHARD MA DESMOPRESSIN AS MANUFACTURED IN TORRANCE AND SAN DIEGO CA CHITOSAN AS MANUFACTURED IN THE WOODLANDS TEXAS SULFOBUTYLETHER BETACYCLODEXTRIN(CAPTISOL) SAFETY STUDIES D L-2(DIFLUOROMETHYL)ORNITHINE MONOHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN CONSHOHOKEN PA DOXAZOSIN MESYLATE AS MANUFACTURED IN GERONA SPAIN CEFOTAXIME SODIUMSTERILE AS MANUFACTURED IN MILANO ITALY MANUFACTURING SITE FACILITIES OPERATING PROCEDURES AND PERSONNEL FOR NEW STERILE PROCESSING FACILITY IN BALTIMORE MD LLD-500 PUMPS AS MANUFACTURED IN BRIDGEPORT CT COMPRESSO GGF 95P AS MANUFACTURED IN HYDERABAD INDIA COMPRESSO GGF95 AS MANUFACTURED IN HYDERABAD INDIA GUAIFENESIN USP 23 AS MANUFACTURED IN HYDERABAD INDIA CHONDROITIN SULFATE TYPE A AS MANUFACTURED IN SIOUX CENTER IOWA AMCINONIDE USP MICRONIZED AS MANUFACTURED IN HAIFA BAY ISRAEL MILRINONE AS MANUFACTURED IN SOUTH HAVEN MI C-8820 INTERNAL LACQUER FOR TUBES AND AEROSOLS AS MANUFACTURED IN SOLOTHURN SWITZERLAND CC00022099WE AS MANUFACTURED IN VONORE, TN. CC00001885D4/WE AS MANUFACTURED IN VONORE, TN. PACKAGING MATERIAL AS MANUFACTURED IN MONTREAL QUEBEC CANADA EMD 121974 AS MANUFACTURED IN LYON CEDEX FRANCE PACKAGING MATERIAL AS MANUFACTURED IN MANDELLO DEL LARIO ITALY BOVINE INSULIN HIGHLY PURIFIED AS MANUFACTURED IN SERIFONTAINE FRANCE CGMP MURINE ASCITES FLUID AS MANUFACTURED IN MADISON WISCONSIN PROTOPORPHYRIN IX DIMETHYLESTER(PPME) AS MANUFACTURED IN CHIBA JAPAN SYNTHETIC PEPTIDE MPS-93 AS MANUFACTURED IN SAN DIEGO CA TETRACYCLINE HYDROCHLORIDE AS MFG IN YINCHUAN CITY NINGXIAHUI NATIONALITY AUTONOMOUS REGION P.R. OF CHINA 815.109 BUBBLEGUM FLAVOR NATURAL & ARTIFICIAL AS MANUFACTURED IN CAROL STREAM IL AKOLINE A MEDIUM CHAIN MONO-DIGLYCERIDE AS MANUFACTURED IN KARLSHMN SWEDEN PACLITAXEL AS MANUFACTURED IN XI'AN CHINA MISOPROSTOL AS MANUFACTURED IN CORK ISLAND IRELAND MISOPROSTOL HPMC DISPERSION 1:100 AS MANUFACTURED IN CORK IRELAND MIRENA INSERTER AS MANUFACTURED IN LEHMO FINLAND T-3811(BMS-284756-01) DRUG SUBSTANCE AS MANUFACTURED IN TOYAMA CITY TOYAMA JAPAN

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4Q2012EXCEL DMF# 14394 I 14395 14396 14397 14398 14399 14400 14401 14402 I 14403 14404 14405 I 14406 14407 14408 A 14409 14410 A 14411 14412 A 14413 A 14414 14415 14416 I 14417 A 14418 I 14419 I 14420 14421 I 14422 I 14423 I I 9/3/1999 II 9/30/1999 A II II 9/22/1999 10/4/1999 II 9/23/1999 IV 9/23/1999 CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTD CHUNGWA CHEMICAL SYNTHESIS & BIOTECH CO LTD MOEHS IBERICA SL CHUNGHWA CHEMICAL SYNTHESIS & BIOTHCH CO, LTD INSTITUTE OF DRUG TECHNOLOGY AUSTRALIA LTD NORDEN PAC PLASTIC AB III 9/14/1999 FRITZ GMBH AND CO KG A I IV II II 9/24/1999 10/6/1999 9/23/1999 LIPOID GMBH FAKO ILACLARI AS DOCTOR REDDYS LABORATORIES LTD LIPOID E SM AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY RANITIDINE HYDROCHLORIDE FORM I BULK AS MFG IN ISTANBUL TURKEY IV 12/9/1998 A II II 9/17/1999 9/23/1999 FINE CHEMICALS CORP PTY LTD A III II 9/15/1999 9/21/1999 C AND J INDUSTRIES INC JUBILANT LIFE SCIENCES LTD A I III IV V 9/18/1999 9/21/1999 8/31/1999 MICA CORP BIRMINGHAM POLYMERS INC GULF PHARMACEUTICAL INUSTRIES I A II III II 9/13/1999 9/16/1999 9/14/1999 A I A A A I I II III III II II II III II 9/8/1999 8/23/1999 9/17/1999 9/10/1999 9/13/1999 9/10/1999 9/7/1999 9/15/1999 FRESENIUS KABI ONCOLOGY LTD DSM RESEARCH OWENSBORO SPECIALTY POLYMERS INC TRACE LIFE SCIENCES INC NV ORGANON BIOTIKA AS OWENS ILLINOIS CLOSURE INC LEK PHARMACEUTICAL AND CHEMICAL CO DD LD PHARMACEUTICAL MEDISIZE CORP SCOTT MEDICAL PRODUCTS STATUS Type SUBMIT DATE I 9/8/1999 HOLDER DABUR INDIA LTD SUBJECT

4Q2012

MANUFACTURING SITE FACILITIES OPERATING PROCEDURES AND PERSONNEL FOR MFG OF METAXALONE IN KALYANI DIST NADIA WEST BENGAL INDIA METAXALONE AS MANUFACTURED IN KALYANI DIST NADIA WEST BENGAL INDIA SABIC LDPE 2201TH12 AS MANUFACTURED IN BEEK THE NETHERLANDS DARAN SL155 AS MANUFACTURED INOWENSBORO KENTUCKY THALLIUM TL-201 RADIOCHEMICAL AS MANUFACTURED IN DENTON TEXAS WARFARIN SODIUM AS MANUFACTURED IN APELDORN THE NETHERLANDS PENICILLIN G PROCAINE AS MANUFACTURED IN SLOVENSKA LUPCA DISPENSING CLOSURES AS MANUFACTURED IN NEW CASTLE PA LOVASTATIN ACTIVE DRUG SUBSTANCE AS MANUFACTURED IN KOLODVORSKA SLOVENIA PACLITAXEL AS MANUFACTURED IN OROMOCTO NEW BRUNSWICK CANADA LEVONOVA(=MIRENA) T-BODY AS MANUFACTURED IN NURMIJARVI FINLAND PERFLUOROPROPANE(OCTAFLUOROPROPANE)GAS AS MANUFACTURED IN PLUMSTEADVILLE PA MICA M-1164 AS MANUFACTURED IN SHELTON CONN BIODEGRADEABLE POLYMERS AS MANUFACTURED IN BIRMINGHAM AL STERILE MANUFACTURING FACILITIES LOCATED IN RAS-AL-KAIMAH, UNITED ARAB EMIRATES 13MM FLAT TIP PLUG .006 ORIFICE AS MANUFACTURED IN MEADVILLE PA CARBAMAZEPINE DRUG SUBSTANCE AS MANUFACTURED IN NANJANGUD MYSORE DISTRICT,KARNATAKA,INDIA. PENBUTOLOL SULFATE AS MANUFACTURED IN EPPING SOUTH AFRICA

UNION QUIMICO FARMACEUTICA SA UQUIFA CLINDAMYCIN PHOSPHATE USP AS MANUFACTURED IN MILAN ITALY SA SCIENTIFIC POLYMER PRODUCTS INC POLY(2-HYDROXYMETHYL METHACRYLATE) AS MANUFACTURED IN ONTARIO NEW YORK

1-METHYLAMINO-1-METHYTHIO-2-NITROETHENE(NMSM) CHEMICAL INTERMEDIATE AS MANUFACTURED IN ANDHRA PRADESH INDIA GLASS TUBULAR AMPOULES FOR PHARMACEUTICAL AND COSMETICAL PACKAGING AS MANUFACTURED IN WERTHEIM MAIN GERMANY SODIUM STARCH GLYCOLATE NF18 AS MANUFACTURED IN TAIWAN ROC FLUCONAZOLE AS MANUFACTURED IN TAIWAN ROC ACEBUTOLOL AS MANUFACTURED IN RUBI SPAIN CALCIUM POLYCARBOPHIL USP 23 AS MANUFACTURED IN TAIWAN ROC TIAZOFURIN AS MANUFACTURED IN BORONIA VICTORIA AUSTRALIA MFG SITE FACILITIES OPERATING PROCEDURES AND PERSONNEL FOR ASTORP SWEDEN LOCATION

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4Q2012EXCEL DMF# 14424 14425 A 14426 A 14427 A 14428 14429 A 14430 I 14431 14432 I 14433 14434 I 14435 I 14436 14437 14438 14439 14440 14441 14442 14443 A 14444 I 14445 14446 14447 14448 14449 14450 14451 14452 14453 14454 I I I I I I I I I I IV IV IV IV IV IV IV IV IV IV 10/12/1999 10/12/1999 10/12/1999 10/12/1999 9/21/1999 9/21/1999 9/21/1999 9/21/1999 9/21/1999 9/21/1999 FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC IV 10/12/1999 FONA INTERNATIONAL INC A A A I I I I II II II II II II II IV 10/5/1999 10/5/1999 10/4/1999 6/23/1999 10/8/1999 10/7/1999 10/7/1999 10/8/1999 FERMIC SA DE CV CIPLA LTD CHATTEM CHEMICALS INC SANYO FINE CO LTD GENZYME CORP PFANSTIEHL LABORATORIES INC SLOVAKOFARMA AS PADDOCK LABORATORIES LLC III 9/27/1999 AMPACET CORP I III III 9/30/1999 9/27/1999 MULTIFILM PACKAGING CORPORATION AMPACET CORP N II 9/30/1999 II 9/28/1999 BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG NOT AN ASSIGNED NUMBER ASAHI GLASS CO LTD A II II 9/30/1999 9/28/1999 DR REDDYS LABORATORIES LTD CORDEN PHARMA SWITZERLAND LLC III 10/1/1999 B BRAUN MELSUNGEN AG II 9/30/1999 UNIGENE LABORATORIES INC STATUS Type SUBMIT DATE I II II 10/21/1999 9/29/1999 HOLDER DUMEX ALPHARMA A S JANSSEN PHARMACEUTICA NV SUBJECT COLISTIN SULFATE MONOCOMPONENT AS MFG IN COPENHAGEN DENMARK

4Q2012

GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN EDINBURGH SCOTLAND AND WETTERN AND GEEL BELGIUM E. COLI DIRECT EXPRESSION PRODUCTION SYSTEM FOR RECOMBINANT SALMON CALCITONIN AS MANUFACTURED IN BOONTON, NJ 1ML AND 4ML DISPENSER SETS AND 120ML ASPIRATOR TUBES AS MANUFACTUREDIN BAD AROLSEN, GERMANY OXAPROZIN AS MANUFACTURED IN ANDHRA PRADESH INDIA 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL SODIUM SALT(POPG NA) AS MANUFACTURED IN LIESTAL SWITZERLAND MELOXICAM JETMILLED AS MFG IN BIBERACH/RIB GERMANY

PAROXETINE HYDROCHLORIDE AMORPHOUS AS MANUFACTURED IN ICHIHARA CITY CHIBA JAPAN CAST POLYPROPYLENE TWISTWRAP AS MANUFACTURED IN ELGIN IL 110916 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE IN DERIDDER LA CARTERSVILLE GA LATEXO TX AND HEATH OH 110869 WHITE COP CMPD POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE IN DERIDDER LA HEATH OH CARTERSVILLE GA AND LATEXO TX CLAVULANATE POTASSIUM AS MANUFACTURED IN MEXICO CITY MEXICO SERTRALINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA BUTABARBITAL SODIUM AS MANUFACTURED IN CHATTANOOGA TENNESSEE ELS(ELASTASE) AS MANUFACTURED IN HUKUI AND HYOGO PREFECTURES JAPAN LEUPROLIDE ACETATE AS MANUFACTURED IN LIESTAL SWITZERLAND N-ACETYL-D-GLUCOSAMINE AS MANUFACTURED IN WAUKEGAN IL MEXILETINE HYDROCHLORIDE AS MANUFACTURED IN HLOHOVEC SLOVAKIA ORA-BRAND OF ORAL PHARMACEUTICAL VEHICLES (ESUB) AS MANUFACTURED IN MINNEAPOLIS MINNESOTA 826.397 N-C CHOCOLATE FLAVOR NATURAL AND ARTIFICIAL AS MANUFACTURED IN CAROL STREAM IL 840.136 ART CREAM FLAVOR POWDER AS MFG IN CAROL STREAM IL 852.263 N-C NA AND ART GOLDEN PUNCH FLAVOR AS MFG IN CAROL STREAM IL 884.044 NA ORANGE EXTRACT AS MFG IN CAROL STREAM IL 800.002 N-C NA ALMOND FLAVOR AS MFG IN CAROL STREAM IL 926.462 NA AND ART VANILLA FLAVOR AS MFG IN CAROL STREAM IL 906.243 N-C NA RASPBERRY FLAVOR WONF AS MFG IN CAROL STREAM IL 895.047 NA ART PINEAPPLE FLAVOR AS MFG IN CAROL STREAM IL 884.612 JUICY ORANGE FLAVOR NA AND ART AS MFG IN CAROL STREAM IL 884.611 JUICY ORANGE FLAVOR NA AND ART AS MFG IN CAROL STREAM IL 884.610 ORANGE CREME FLAVOR EMULSION NA AND ART AS MFG IN CAROL STREAM IL

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4Q2012EXCEL DMF# 14455 I 14456 14457 14458 14459 14460 I 14461 14462 I 14463 14464 14465 14466 14467 14468 14469 14470 14471 14472 A 14473 14474 14475 I 14476 I 14477 14478 14479 14480 14481 14482 14483 14484 14485 14486 14487 14488 14489 14490 A I I I I I I I I I I I I N II III II II IV IV IV IV IV IV IV IV IV 10/15/1999 10/18/1999 10/20/1999 10/14/1999 10/18/1999 10/15/1999 10/15/1999 10/18/1999 10/18/1999 10/18/1999 10/18/1999 10/18/1999 10/18/1999 III 10/8/1999 SOCIETA INDUSTRIA COMMERCIO APPLIAZION TECNICHE E FARMACEUTICHE SRL OLON SPA DONEGAL HEALTHCARE LTD BOSTON BIOSYSTEMS WOCKHARDT LTD FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIOANL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC NOT AN ASSIGNED NUMBER A A III II II 10/13/1999 10/19/1999 10/13/1999 POLIMERI EUROPA SPA UQUIFA MEXICO SA DE CV GLAXOSMITHKLINE I I I A A A A I I IV IV IV III II II II II II II 10/6/1999 10/7/1999 10/7/1999 10/1/1999 9/29/1999 10/6/1999 10/11/1999 10/14/1999 10/8/1999 10/8/1999 FONA INTERNATIONAL INC FLAVORS NORTH AMERICA INC FONA INTERNATIONAL INC POLYONE CORP 3M PURIFICATION INC SHASUN PHARMACEUTICALS LTD LONZA BIOLOGICS PLC RANBAXY LABORATORIES LTD SICOR SPA TEVA PHARMACEUTICAL INDUSTRIES LTD I IV IV 9/21/1999 9/21/1999 FONA INTERNATIONAL INC FONA INTERNATIONAL INC 839.099 N-C CRANBERRY FLAVOR NA(WONF) AS MFG IN CAROL STREAM IL I I I I IV IV IV IV IV 9/21/1999 9/21/1999 9/21/1999 9/12/1999 9/21/1999 FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC STATUS Type SUBMIT DATE IV 9/21/1999 HOLDER FONA INTERNATIONAL INC SUBJECT

4Q2012

884.011 ORANGE CREME FLAVOR NA AND ART FLAVOR AS MFG IN CAROL STREAM IL 861.057 N-C NATURAL LEMON HONEY FLAVOR(WONF) AS MFG IN CAROL STREAM IL 856.055 N-C NATURAL GRAPE FLAVOR(WONF) AS MFG CAROL STREAM IL 856.012 N-C NATURAL GRAPE FLAVOR AS MFG IN CAROL STREAM IL 856.003 NC ART GRAPE FLAVOR AS MFG IN CAROL STREAM IL 852.330 RED PUNCH FLAVOR NA AND ART(ALCOHOL FREE) AS MFG IN CAROL STREAM IL

825.527 CHERRY FLAVOR NA AND ART(ALCOHOL FREE) ETOH AS MFG IN CAROL STREAM IL 915.192 ART STRAWBERRY FLAVOR AS MFG IN CAROL STREAM IL 890.045 OS NATURAL MOCHA FLAVOR AS MFG IN CAROL STREAM IL 944.023 OS ART KIWI FLAVOR AS MFG IN CAROL STREAM IL CC10004850WE AS MANUFACTURED IN VONORE, TN. POLYNET CARTRIDGE AS MFG IN ENFIELD CT RANITIDINE HYDROCHLORIDE AS MFG IN CUDDALORE INDIA P67.6 ANTIBODY AS MFG IN BERKSHIRE UK LOVASTATIN USP AS MFG IN HIMACHAL PRADESH INDIA N-ACETYL CALICHEAMICIN AS MFG IN MILAN AND PAVIA ITALY NAC-GAMMA CALICHEAMICIN ACBUT OSU(PIVOTAL INTERMEDIATE) AS MFG IN MILAN AND VERCELLI ITALY RIBLENE FM53 AS MFG IN FERRARA ITALY CIPROFLAXIN HCL AS MFG IN BARCELONA SPAIN PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MFG IN CARRIGALINE IRELAND AND AYRSHIRE SCOTLAND PACKAGING MATERIAL RELATED TO THE PRODUCTION OF GLASS AMPOULES AS MFG IN TREVIGLIO(BG)ITALY MYCOPHENOLIC ACID NS TECHNICAL GRADE AS MFG IN SETTIMO TORINESE(TO)ITALY TIP & CAP DROPPER SYSTEM AS MFG IN LETTERKENNY IRELAND GTI-2040 DRUG SUBSTANCE AS MFG IN BEDFORD MA AZITHROMYCIN USP AS MFG IN ANKLESHWAR INDIA 807.117 N-C MIXED BERRY FLAVOR NA(WONF) AS MFG IN CAROL STREAM IL 815.111 BUBBLEMINT FLAVOR NA & ART AS MFG IN CAROL STREAM IL 815.112 BUBBLEMINT FLAVOR NA & ART AS MFG IN CAROL STREAM IL 856.409 GRAPE FLAVOR ART AS MFG IN CAROL STREAM IL 926.336 N-C NA & ART VANILLA FLAVOR AS MFG IN CAROL STREAM IL 932.049 WINTERGREEN FLAVOR ART AS MFG IN CAROL STREAM IL 932.050 WINTERGREEN FLAVOR ART AS MFG IN CAROL STREAM IL 932.051 WINTERGREEN FLAVOR ART AS MFG IN CAROL STREAM IL 936.404 MASKING AGENT FLAVOR NA AS MFG IN CAROL STREAM IL

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4Q2012EXCEL DMF# 14491 14492 14493 14494 I 14495 14496 I 14497 14498 A 14499 I 14500 14501 A 14502 14503 14504 A 14505 14506 I 14507 14508 14509 I 14510 14511 14512 14513 I 14514 14515 14516 14517 14518 14519 14520 I 14521 14522 A I II III 10/15/1999 8/13/1999 DAICEL CHEMICAL INDUSTRIES LTD POLIMERI EUROPA FRANCE SA I A A A I I I IV III III III III I 11/5/1999 11/5/1999 10/1/1999 11/22/1999 11/8/1999 11/8/1999 10/15/1999 PRONOVA BIOMEDICAL AS FMC BIOPOLYMER AS POLYONE CORP ARDAGH GLASS GMBH DSM RESEARCH DSM RESEARCH DAICEL CHEMICAL INDUSTRIES LTD I A I III II II III 10/27/1999 10/29/1999 10/26/1999 10/27/1999 PRESSPART INC MEDICHEM SA TEVA PHARMACEUTICAL INDUSTRIES LTD AMPACET CORP I I II IV I 11/9/1999 11/1/1999 11/5/1999 QUIMICA FINA FARMEX SA DE CV FONA INTERNATIONAL INC LA CALHENE A II III 10/27/1999 9/29/1999 MALLINCKRODT INC AGIFIN SRL A I II II II 10/29/1999 10/27/1999 10/22/1999 I II II 10/21/1999 10/28/1999 EVERLIGHT CHEMICAL IND CORP HOECHST MARION ROUSSEL PHARMACEUTICALS INC MALLINCKRODT INC BIOXEL PHARMA INC GADOR SA I 10/21/1999 EVERLIGHT CHEMICAL IND CORP I III III 10/20/1999 10/18/1999 BOREALIS AG LAJOVIC TUBA EMBALAZA, D.D. I I III 10/11/1999 10/22/1999 MEITO SANGYO CO LTD KANEKA TEXAS CORP STATUS Type SUBMIT DATE I A I IV IV II II 10/10/1999 10/10/1999 10/14/1999 10/5/1999 HOLDER ZSCHIMMER AND SCHWARZ ITALIANA SPA ZSCHIMMER AND SCHWARZ ITALIANA SPA RP SCHERER NORTH AMERICA J K DRUGS AND PHARMACEUTICALS LTD SUBJECT GM 9011/C AS MFG IN TRICERRO(VC)ITALY ZETESOL LES 2 AS MFG IN TRICERRO(VC)ITALY ACCUTANE (ISOTRETINOIN) AS MFG IN ST PETERSBURG FL

4Q2012

7-AMINODESACETOXYCEPHALOSPORANIC ACID (7-ADCA) CHEMICAL INTERMEDIATE AS MFG IN UTTAR PRADESH INDIA MFG AND QUALITY CONTROL OF SUBSTANCES-NAGOYA-AS IN AICHI JAPAN PA-10 PA-20 PA-30 PA-40 PA-50 PA-101 AND PA-110 AS MFG IN PASEDENA TX TAGASAGO JAPAN AND WESTERIO-OEVEL BELGIUM HE1903 AS MFG IN BERINGEN BELGIUM ALUMINUM TUBES FOR USE IN THE PHARMACEUTICAL INDUSTRY AS MFG IN LJUBLJANA SLOVENIA MFG SITE FACILITIES OPERATING PROCEDURES AND PERSONEL FOR FACTORY LOCATED IN TAOYUAN HSIEN TAIWAN MISOPROSTOL AS MFG IN TAOYUAN HSIEN TAIWAN HMR-4052 AS MFG IN KAWAGOE CITY SAITAMA JAPAN OXYMORPHONE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN ST LOUIS MO PACLITAXEL AS MFG IN SAINTE-FOY QC CANADA PAMIDRONIC ACID ACTIVE PHARMACEUTICAL INGREDIENT AS MFG IN BUENOS ARIES ARGENTINA SUFENTANIL CITRATE USP (ESUB) AS MANUFACUTRED IN ST LOUIS MO SECURECLIK 5ML SAFETY SYRINGES WITH RETRACTABLE NEEDLE AS MFG IN RENATE(MI)ITALY ITRACONAZOLE AS MFG IN VILLA CORREGIDORA QUERETARO MEXICO 802.029 N-C ANISE FLAVOR NATURAL AS MFG IN CAROL STREAM IL MFG SITE FACILITIES OPERATING PROCEDURES AND PERSONEL FOR PHARMACEUTICAL PACKAGE COMPONENT PROCESSING FACILITY LOCATED IN VENDOME FRANCE EXTRUDED CANS MFG AND CLEANED IN CARY NC FLUVOXAMINE MALEATE AS MFG IN CELRA(GIRONA)SPAIN THIOTEPA AS MFG IN SANTHIA(VERCELLI)ITALY 11976 WHITE PE POLYETHYLENE MASTERBATCH AS MFG IN TERRE HAUTE INDERIDDER LACARTERSVILLE GAHEATH OH AND LATEXO TX MFG SITE FACILITIES OPERATING PROCEDURES AND PERSONEL FOR OSLO NORWAY CHITOSAN CHLORIDE AND CHITOSAN GLUTAMATE AS MFG IN OSLO NORWAY CC00017246WE/D4 AS MANUFACTURED IN VONORE, TN. AMBER GLASS CONTAINERS AS MFG IN BAD MUNDER, GERMANY STAMYLAN P 15M10 AS MFG IN GELEEN THE NETHERLANDS STAMYLAN P 16M10 AS MFG IN GELEEN THE NETHERLANDS FACILITIES PERSONEL AND GENERAL OPERATING PROCEDURES OF ARAI PLANT FOR MFG OF CHIRAL PAK ADCSP FOR LIQUID CHROMAIC RESOLUTION IN NIIGATA JAPAN CHIRALPAK AD CSP AS MFG IN NIIGATA JAPAN FLEXIRENE MR50 AS MFG IN DUNKIRK FRANCE

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4Q2012EXCEL DMF# 14523 I 14524 14525 14526 14527 I 14528 14529 14530 14531 I 14532 I 14533 I 14534 14535 14536 14537 14538 14539 A 14540 14541 14542 14543 I 14544 I 14545 I 14546 14547 14548 14549 14550 14551 I 14552 14553 14554 14555 I I I I IV IV IV IV 11/14/1999 11/14/1999 11/14/1999 11/14/1999 FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC I I I I I IV IV IV IV IV IV 11/14/1999 11/14/1999 11/14/1999 11/14/1999 11/14/1999 11/14/1999 FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC IV 11/14/1999 FONA INTERNATIONAL INC IV 11/14/1999 FONA INTERNATIONAL INC A A I II II IV IV 11/18/1999 11/22/1999 11/14/1999 11/14/1999 A I A I A II IV II II II II 11/11/1999 11/11/1999 11/16/1999 11/19/1999 11/9/1999 11/18/1999 DIPHARMA FRANCIS SRL COLORS FOR PLASTICS INC EVONIK CORPORATION FUJISAWA PHARMACEUTICAL CO LTD SICOR DE MEXICO SA DE CV III 11/15/1999 II 11/15/1999 I A I II II II III 11/10/1999 11/12/1999 11/16/1999 11/15/1999 J K DRUGS AND PHARMACEUTICALS LTD APOTEX PHARMACHEM INC WOCKHARDT LTD BORMIOLI ROCCO E FIGLIO SPA PLASTIC DIV PHARMACEUTICAL FINE CHEMICALS(PFC) BAHAMAS LTD HI TECH POLYMERS(INDIA) PVT LTD A A I II II III II 11/15/1999 11/12/1999 11/10/1999 11/9/1999 LG LIFE SCIENCES LTD SAFC BIOSCIENCES INC CANADA COLORS AND CHEMICALS LTD CHEMI SPA STATUS Type SUBMIT DATE III 10/15/1999 HOLDER RISDON SA SUBJECT

4Q2012

35ML PILL JARS HDPE WHITE MOULD REFERENCE 1600 AS MFG IN OFFRANVILLE FRANCE FOR AL HIKMA/ JORDAN GEMIFLOXACIN MESYLATE AS MFG IN IKSAN CITY CHUNBUK-DO KOREA EX-CELL 325 PF CHO PROTEIN FREE MEDIUM AS MFG IN DENVER PENNSYLVANIA PACKAGING MATERIAL AS MFG IN COLBORNE ONTARIO CANADA POPC(1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHORYLCHOLINE) AS MFG IN PATRICA(FROSINONE)ITALY CEPHRADINE USP AS MFG IN UTTAR PRADESH INDIA FLUVOXAMINE MALEATE AS MFG IN BRANTFORD ONTARIO CANADA FAMOTIDINE USP AS MFG IN ANKLESHWAR INDIA SPECIAL CHILD PROOF CAP 028MM AS MFG IN CASTLEGUELFO(PR) RIVANAZZANO(PV)ITALY AND SAINT SUPICE FRANCE TERAZOSIN HYDROCHLORIDE AS MFG IN RIVIERA BEACH FLORIDA AND FREEPORT GRAND BAHAMAS HDPE BOTTLES AND CLOSURES FOR PHARMACEUTICAL APPLICATIONS AS MFG IN GUJARATINDIA BUPROPION HCL AS MFG IN MILAN ITALY R28415 AS MFG IN ELK GROVE IL LISINOPRIL CRUDE AS MFG IN COURBEVOIE AND HAM FRANCE FK8453 DRUG SUBSTANCE AS MFG IN HYOGO AND OSAKA JAPAN AMCINONIDE AS MFG IN LERMA MEXICO

UNION QUIMICO FARMACEUTICA SA UQUIFA CLINDAMYCIN HYDROCHLORIDE USP AS MFG IN MILAN ITALY SA NV ORGANON TESTOSTERONE UNDECANOATE AS MFG IN OSS THE NETHERLANDS EVONIK TECHNOCHEMIE GMBH FONA INTERNATIONAL INC FONA INTERNATIONAL INC TRAMADOL HYDROCHLORIDE AS MFG IN RADEBEUL, GERMANY 2050A TUTTI FRUTTI BASE OIL AS MFG IN CAROL STREAM IL 852.049 N-C NATURAL AND ARTIFICIAL FUIT PUNCH FLAVOR AS MFG IN CAROL STREAM IL 852.013 STRAW PUNCH FLAVOR(A NATURAL AND ARTIFICIAL FLAVOR) AS MFG IN CAROL STREAM IL 2038A NATURAL AND ARTIFICIAL TROPICAL FRUIT PUNCH FLAVOR AS MFG IN CAROL STREAM IL 2038B INTERMEDIATE B AS MFG IN CAROL STREAM IL 856.039 N-C ARTIFICIAL CONCORD GRAPE FLAVOR AS MFG IN CAROL STREAM IL 856.316 N-C ARTIFICIAL CONCORD GRAPE FLAVOR AS MFG IN CAROL STREAM IL 856.107 N-C ARTIFICIAL CONCORD GRAPE FLAVOR AS MFG IN CAROL STREAM IL 884.596 N-C ORANGE CREME FLAVOR NATURAL(WONF) AS MFG IN CAROL STREAM IL 600.014 ACETALDEHYDE NATURAL 50% SOLN/TRIACETIN AS MFG IN CAROL STREAM IL 10252A ORANGE CREAM FLAVOR NATURAL(WONF) AS MFG IN CAROL STREAM IL 929.005 N-C ARTIFICIAL WATERMELON FLAVOR AS MFG IN CAROL STREAM IL 929.001 ARTIFICIAL WATERMELON FLAVOR AS MFG IN CAROL STREAM IL 807.216 N-C BERRY FLAVOR(AN ARTIFICIAL FLAVOR) AS MFG IN CAROL STREAM IL

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4Q2012EXCEL DMF# 14556 14557 14558 14559 14560 14561 14562 14563 I 14564 14565 I 14566 14567 14568 14569 14570 14571 I 14572 14573 I 14574 I 14575 14576 14577 I 14578 14579 14580 14581 I 14582 14583 14584 14585 14586 14587 14588 14589 I 14590 I IV 11/15/1999 FONA INTERNATIONAL INC 606.500 GERANIUM OIL CHINESE AS MFG IN CAROL STREAM IL I I I I I I I IV IV IV IV IV IV IV IV 11/15/1999 11/15/1999 11/14/1999 11/15/1999 11/15/1999 11/15/1999 11/15/1999 11/15/1999 FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC I I I IV IV IV IV 11/15/1999 11/15/1999 11/15/1999 11/15/1999 FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC I I IV IV IV 11/15/1999 11/15/1999 11/15/1999 FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC IV 11/15/1999 FONA INTERNATIONAL INC I IV IV 11/15/1999 11/15/1999 FONA INTERNATIONAL INC FONA INTERNATIONAL INC I I I I I IV IV IV IV IV IV 11/14/1999 11/14/1999 11/15/1999 11/15/1999 11/15/1999 11/15/1999 FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC 8539Z RUM FLAVOR (NATURAL) AS MFG IN CAROL STREAM IL 5839B COMPOUND 1036 NATURAL AS MFG IN CAROL STREAM IL 1837D ARTIFICIAL STRAWBERRY FLAVOR AS MFG IN CAROL STREAM IL 915.136 ARTIFICIAL STRAWBERRY BASE OIL AS MFG IN CAROL STREAM IL 258C ARTIFICIAL RUM ETHER AS MFG IN CAROL STREAM IL I IV IV 11/14/1999 11/14/1999 FONA INTERNATIONAL INC FONA INTERNATIONAL INC STATUS Type SUBMIT DATE I I I I I I I IV IV IV IV IV IV IV IV 11/15/1999 11/15/1999 11/14/1999 11/14/1999 11/14/1999 11/14/1999 11/14/1999 11/14/1999 HOLDER FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC SUBJECT 906.423 RASPBERRY FLAVOR ARTIFICIAL AS MFG IN CAROL STREAM IL

4Q2012

6788D NATURAL AND ARTIFICIAL RASPBERRY CONC AS MFG IN CAROL STREAM IL 807.101 N-C NATURAL AND ARTIFICIAL BERRY FLAVOR AS MFG IN CAROL STREAM IL 6922B NATURAL AND ARTIFICIAL BERRY OIL AS MFG IN CAROL STREAM IL 6711C ARTIFICIAL IRISONE AS MFG IN CAROL STREAM IL 825.032 N-C ARTIFICIAL WILD CHERRY FLAVOR AS MFG IN CAROL STREAM IL 825.029 ARTIFICIAL WILD CHERRY FLAVOR AS MFG IN CAROL STREAM IL 852.002 N-C NATURAL AND ARTIFICIAL FRUIT PUNCH FLAVOR AS MFG IN CAROL STREAM IL 611B NATURAL AND ARTIFICIAL FRUIT PUNCH FLAVOR AS MFG IN CAROL STREAM IL 852.017 N-C TUTTI FRUTTI FLAVOR(A NATURAL FLAVOR) AS MFG IN CAROL STREAM IL

915.697 N-C STRAWBERRY FLAVOR NATURAL AND ARTIFICIAL AS MFG IN CAROL STREAM IL 10257A ARTIFICIAL STRAWBERRY OIL AS MFG IN CAROL STREAM IL 612.600 METHYL THIOBUTYRATE 1% SOLN/ETOH(1208850) AS MFG IN CAROL STREAM IL 600.297 ALPHA AMYL CINNAMIC ALDEHYDE 1% SOLN.PG AS MFG IN CAROL STREAM IL 612.500 METHYL SULFIDE 1% SOLN/ETOH(1208750) AS MFG IN CAROL STREAM IL 612.401 2-ME-2-PENTENAL 1% SOLN/PG(1208420) AS MFG IN CAROL STREAM IL 906.300 N-C NATURAL AND ARTIFICIAL RASPBERRY FLAVOR AS MFG IN CAROL STREAM IL 6788A ARTIFICIAL RASPBERRY KEY AS MFG IN CAROL STREAM IL 5638B SOLVENT BASE (TEC) AS MFG IN CAROL STREAM IL 807.120 N-C TRIPLEBERRY FLAVOR ARTIFICIAL AS MFG IN CAROL STREAM IL 809.085 N-C NATURAL AND ARTIFICIAL BLUEBERRY FLAVOR AS MFG IN CAROL STREAM IL 2915C ARTIFICIAL BLUEBERRY FLAVOR AS MFG IN CAROL STREAM IL 856.054 ARTIFICIAL CONCORD GRAPE BASE OIL AS MFG IN CAROL STREAM IL 981N NATURAL BLUEBERRY FLAVOR AS MFG IN CAROL STREAM IL 758A NATURAL BLUEBERRY FORTIFIER AS MFG IN CAROL STREAM IL 600.300 AMBRETTE SEED ABSOLUTE AS MFG IN CAROL STREAM IL 601.070 BORONIA ABSOLUTE 1% SOLN/ETOH(1003600) AS MFG IN CAROL STREAM IL 601.090 BUCHU LEAF OIL 1% SOLN/ETOH AS MFG IN CAROL STREAM IL 606.400 GALBANUM RESINOIDE 1% SOLN/ETOH(1013220) AS MFG IN CAROL STREAM IL

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4Q2012EXCEL DMF# 14591 14592 14593 14594 14595 I 14596 I 14597 14598 I 14599 14600 14601 14602 14603 14604 14605 14606 I 14607 14608 14609 I 14610 14611 14612 14613 I 14614 14615 14616 14617 14618 14619 14620 A 14621 A 14622 14623 A I II II 12/10/1999 12/16/1999 QUIMICA SINTETICA SA AVENTIS PHARMA LTD TERCONAZOLE AS MFG IN MADRID SPAIN PYRAZINAMIDE AS MFG IN WALTLOO SOUTH AFRICA V 11/26/1999 I I A A N A II IV 12/13/1999 12/8/1999 II II II II 12/9/1999 12/9/1999 12/2/1999 12/6/1999 DAIICHI ASUBIO PHARMA CO LTD SAFC INC SAFC BIOSCIENCES INC SAFC BIOSCIENCES INC NOT AN ASSIGNED NUMBER SA AJINOMOTO OMNICHEM NV WACKER CHEMICAL CORPORATION, WACKER BIOSOLUTIONS DIVISION CHEMUNEX VINORELBINE TARTRATE AS MFG IN LOUVAIN-LA-NEUVE BELGIUM BETA-CYCLODEXTRIN AS MFG IN EDDYVILLE IOWA I A A III II II V 11/19/1999 12/7/1999 12/9/1999 11/30/1999 DEX-POLYMERS V O F R TECH UENO LTD TEVA PHARMACEUTICAL INDUSTRIES LTD GLAND PHARMA LTD I I II III I 11/5/1999 11/29/1999 12/7/1999 SIEGFRIED CHEMICALS INC FLINT HILLS RESOURCES LP S.C. ANTIBIOTICE S.A. A I A I A A I II II III II II II II I 11/29/1999 11/30/1999 11/25/1999 11/23/1999 11/23/1999 12/1/1999 11/19/1999 11/3/1999 TEVA PHARMACEUTICAL INDUSTRIES LTD ERREGIERRE SPA LOG PLASTIC PRODUCTS SCHERING AKTIENGESELLSCHAFT DR REDDYS LABORATORIES LTD AVANTI POLAR LIPIDS INC TEVA PHARMACEUTICALS USA INC SIEGFRIED CHEMICALS INC I IV III 11/15/1999 11/18/1999 FONA INTERNATIONAL INC AMPACET CORP IV 11/15/1999 FONA INTERNATIONAL INC STATUS Type SUBMIT DATE I I I I IV IV IV IV IV 11/15/1999 11/15/1999 11/14/1999 11/14/1999 11/15/1999 HOLDER FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC SUBJECT

4Q2012

609.200 JASMIN ABSOLUTE 1% SOLN/ETOH(1014625) AS MFG IN CAROL STREAM IL 612.010 MANDARIN PETT TRPLS 1% SOLN/ETOH AS MFG IN CAROL STREAM IL 915.005 N-C ARTIFICIAL STRAWBERRY FLAVOR AS MFG IN CAROL STREAM IL 915.004 ARTIFICIAL STRAWBERRY BASE OIL AS MFG IN CAROL STREAM IL 915.747 STRAWBERRY FLAVOR(AN ARTIFICIAL FLAVOR) AS MFG IN CAROL STREAM IL 915.727 N-C STRAWBERRY FLAVOR NATURAL AND ARTIFICIAL AS MFG IN CAROL STREAM IL 1837R N-C STRAWBERRY FLAVOR ARTIFICIAL AS MFG IN CAROL STREAM IL 10799-A TALC POLYETHYLENE MASTERBATCH AS MFG IN TERRE HAUTE INDERIDDER LACARTERSVILLE GAHEATH OH AND LATEXO TX SIMVASTATIN AS MFG IN DEBRECCEN HUNGARY NABUMETONE AS MFG IN BERGAMO ITALY PLASTIC BOTTLES AS MFG IN KIBBUTZ ASDOT YA'AKOV ICHUD ISRAEL ZK807834 AS MFG IN BERLIN GERMANY KETOROLAC TROMETHAMINE AS MFG IN ANDHRA PRADESH INDIA 1,2-DIERUCOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DEPC) AS MFG IN ALABASTER AL CEFACLOR USP AS MFG IN MEXICO MO ORGANIZATION MFG SITE BUILDING FACILITIES AND OPERATION OF FACTORY IN TAOYUAN TAIWAN ROC VALPROIC ACID USP AS MFG IN TAOYUAN TAIWAN ROC PP11530V POLYPROPYLENE AS MFG IN ODESSA AND LONGVIEW TEXAS FACILITIES PERSONEL AND GENERAL OPERATING PROCEDURES FOR FACTORY IN IASI ROMANIA ETHYLENE OCTENE COPOLYMERS AS MFG IN HEERLEN THE NETHERLANDS UNOPROSTONE ISOPROPYL AS MFG IN SANDA HYOGO JAPAN METOPROLOL SUCCINATE AS MFG IN BE'ER SHEVA AND PETAH TIQVA ISRAEL STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN AMEEPET AND DUNDIGAL, INDIA SUN A0026 DRUG SUBSTANCE AS MFG IN TOKYO JAPAN 2-METHOXYESTRA-3,17 B-DIOL AS MFG IN MADISON WI EX-CELL PF CHO PART A(MODIFIED) AS MFG IN DENVER PENNSYLVANIA EX-CELL PF CHO MEDIUM(MODIFIED)DEFICIENT AS MFG IN DENVER PENNSYLVANIA

DESCRIPTION AND DATA TO SUPPORT USE OF SOLID PHASE CYTOMETER FOR THE MEASUREMENT OF VIABLE MICRO-ORGANISMS IN PHARMACEUTICAL WATER SYSTEMS

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4Q2012EXCEL DMF# 14624 I 14625 14626 A 14627 14628 14629 14630 14631 14632 14633 14634 14635 I 14636 14637 14638 14639 14640 A 14641 I 14642 14643 14644 14645 14646 14647 14648 14649 14650 14651 14652 14653 14654 14655 I 14656 14657 I 14658 14659 I A II II 1/7/2000 1/6/2000 NANOSYSTEMS SYN TECH CHEM AND PHARM CO LTD A IV I 12/7/1999 12/25/1999 ROXLOR SA GLENMARK PHARMACEUTICALS LTD A A A I A I A A I A A A I III II IV II II II II II II II III II II II 12/22/1999 12/22/1999 12/23/1999 12/28/1999 12/27/1999 12/28/1999 12/28/1999 12/30/1999 12/29/1999 12/30/1999 12/2/1999 1/3/2000 12/28/1999 12/29/1999 MAC CLOSURES INC CATALENT FRANCE BEINHEIM SA DMV FONTERRA EXCIPIENTS GMBH CO KG TAIHO PHARMACEUTICAL CO LTD PCAS SUMITOMO CHEMICAL CO LTD TARO PHARMACEUTICAL INDUSTRIES LTD MERCK AND CO INC SCHWEIZERHALL MANUFACTURING CO TARO PHARMACEUTICAL INDUSTRIES LTD MYLAN TECHNOLOGIES INC FAKO ILACLARIA AS TEVA GROUP API DIVISION NAPP TECHNOLOGIES INC II 12/23/1999 ARADIGM CORP A A A A II II II II II 12/18/1999 12/20/1999 12/16/1999 12/16/1999 12/22/1999 CEDARBURG PHARMACEUTICALS INC CIPLA LTD INDUSTRIAS MONFEL SA DE CV EASTMAN CHEMICAL CO ABBVIE INC A A A A A I A A II IV IV II III I II III III 12/17/1999 12/15/1999 12/15/1999 12/15/1999 12/17/1999 12/15/1999 12/17/1999 12/2/1999 12/8/1999 SANOFI AVENTIS DEUTSCHLAND GMBH BAYER SCHERING PHARMA AG BAYER SCHERING PHARMA AG XIAN LIJUN PHARMACEUTICAL CO LTD GALLAZZI SPA LEIRAS OY SANOFI AVENTIS DEUTSCHLAND GMBH LONSTROFF AG SPARTECH COLOR I III II 12/9/1999 12/16/1999 COLOR MASTER INC MALLINCKRODT INC STATUS Type SUBMIT DATE III 12/9/1999 HOLDER COLOR MASTER INC SUBJECT

4Q2012

BN11107E CHOCOLATE BROWN COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN RD1583E 187C RED COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN NOSCAPINE USP SMALL CRYSTALS CODE 6040 AND NOSCAPINE HYDROCHLORIDE PURIFIED CODE 6150 AS (ESUB) MANUFACTURED IN ST LOUIS MISSOURI CICLOPIROX AS MFG IN FRANKFURT, GERMANY PDMS 373MI TUBING AS MFG IN TURKU FINLAND 4910 UNFILLED ELASTOMER AS MFG IN TURKU FINLAND ERYTHROMYCIN BASE USP 23 AS MFG IN XIAN SHAANXI PRC FLEXAPHARM PRODUCTS AS MFG IN TRADATE(VARESE)ITALY MFG FACILITY EQUIPMENT AND PERSONEL FOR SITE IN TURKU FINLAND CICLOPIROX OLAMINE AS MFG IN FRANKFURT, GERMANY BROMOBUTYL RUBBER COMPOUNDS AS MFG IN AARAU SWITZERLAND WH 18485 WHITE POLYETHYLENE CONCENTRATE AS MFG IN STRAFORD ONTARIO CANADA BUTABARBITAL SODIUM AS MFG IN GRAFTON WISCONSIN FLUTAMIDE (ESUB) AS MANUFACTURED IN BANGALORE AND MAHARASHTRA, INDIA ACETAMINOPHEN AS MFG IN SAN LUIS POTOSI SLP MEXICO HYDROQUINONE USP AS MFG IN KINGSPORT TN 5-DESOSAMINYL-6-0-METHYL ERYTHRONOLIDE (ESUB) AS MANUFACTURED IN KENT ENGLAND AERX MORPHINE SULFATE PAIN MANAGEMENT SYSTEM AS MFG IN HAYWARD CA AND DES PLAINES IL PLASTIC DISPENSER AS MFG IN WATERLOO QUEBEC CANADA DUTASTERIDE SOFT GELATIN CAPSULES .5MG AS MFG IN BEINHEIM FRANCE RESPITOSE ML001 AS MFG IN VEGHEL, THE NETHERLANDS GTS-21 AS MFG IN IBARAKI JAPAN DIVALPROEX SODIUM AS MFG IN LIMAY FRANCE MCC-555 AS MFG IN GIFU PREFECTURE JAPAN CLOBETASOL-17-PROPIONATE USP MICRONIZED AS MFG IN HAIFA BAY ISRAEL OMEPRAZOLE MAGNESIUM AS MFG IN ALBANY GA METYRAPONE AS MFG IN GREENVILLE SC BETAMETHASONE DIPROPIONATE AS MFG IN HAIFA BAY ISRAEL MEDIRELEASE 2249 AS MANUFACTURED IN ST ALBANS VT (ESUB) CEFUROXIME AXETIL AMORPHOUS AS MFG IN ISTANBUL TURKEY ACYCLOVIR USP AS MFG IN BEER SHEVA ISRAEL SULFABENZAMIDE AS MFG IN GREENVILLE SC MICRONIZED IN KENT ENGLAND AND TESTED IN RANDOLPH NJ EMPTY GELATINCAPSULES AS MFG IN LA CIOTAT CEDEX FRANCE MFG SITE FACILITIES OPERATING PROCEDURES AND PERSONEL FOR SAPUR NASIK INDIA SITE L-822,179 ORAL NANOCRYSTAL COLLOIDAL DISPERSION-MEDIA MILLING PROCESS DILTIAZEM HYDROCHLORIDE USP AS MFG IN HSIN YING TAIWAN ROC

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4Q2012EXCEL DMF# 14660 A 14661 14662 I 14663 14664 14665 14666 14667 14668 14669 14670 A 14671 14672 A 14673 14674 I 14675 A 14676 14677 14678 14679 14680 I 14681 A 14682 14683 14684 I 14685 14686 A 14687 14688 14689 14690 14691 14692 I I A A I A II II II II III II 1/24/2000 1/17/2000 1/21/2000 1/21/2000 12/23/1999 1/31/2000 3M PHARMACEUTICALS INC SALSBURY CHEMICALS INC QIAGEN GMBH QIAGEN GMBH ASPELL POLYMERES SICOR DE MEXICO SA DE CV A II II 1/26/2000 1/26/2000 CATALENT PHARMA SOLUTIONS LLC CIPLA LTD A I IV IV III 1/24/2000 1/24/2000 1/27/2000 TAKASAGO INTERNATIONAL CORP TAKASAGO INTERNATIONAL CORP SHINKONG SYNTHETIC FIBERS CORP III 1/20/2000 I I I A III III II II V 1/12/2000 1/14/2000 1/21/2000 1/19/2000 1/21/2000 FBG ANCHOR WINPAK HEAT SEAL PACKAGING INC YAKULT HONSHA CO LTD SANDOZ INDUSTRIAL PRODUCTS SPA CHLOPROPHAM TASK FORCE C/O MCDERMOTT WILL AND EMERY DANAPAK FLEXIBLES AS II 1/13/2000 EUTICALS SPA I III I 12/30/1999 1/7/2000 M A HANNA COLOR BOOTS CO PLC I III III 1/14/2000 1/14/2000 A A A A I A A III III III III III III III III 12/30/1999 12/30/1999 12/30/1999 12/30/1999 12/30/1999 12/30/1999 12/30/1999 1/3/2000 A II II 1/3/2000 1/10/2000 INDUSTRIALE CHIMICA SRL BEIJING SECOND PHARMACEUTICAL FACTORY POLYONE CORP POLYONE CORP POLYONE CORP POLYONE CORP POLYONE CORP POLYONE CORP POLYONE CORP ST GOBAIN PERFORMANCE PLASTICS FRANCE WINPAK HEAT SEAL PACKAGING INC AMCOR FLEXIBLES ITALIA SRL ZOPICLONE AS MFG IN SARONNO(VARESE)ITALY ISONIAZID USP23 AS MFG IN CHAOYANG DIST BEIJING PRC CC00016123WE AS MANUFACTURED IN VONORE, TN. CC10004846WE AS MANUFACTURED IN VONORE, TN. CC00017504DR AS MANUFACTURED IN VONORE, TN. CC00017506WE/DR AS MANUFACTURED IN VONORE, TN. CC10004836WE AS MANUFACTURED IN VONORE TN CC00015904WE AS MANUFACTURED IN VONORE, TN. CC00022347DR AS MANUFACTURED IN VONORE, TN. STATUS Type SUBMIT DATE II 1/11/2000 HOLDER NISSAN CHEMICAL INDUSTRIES LTD SUBJECT

4Q2012

NK-104 DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN ONODA YAMAGUCHI JAPAN

ELASTOMERIC CLOSURES FOR ALUMINUM CONTAINERS & PHARMACEUTICAL VIALS AS MFG IN CHARNY FRANCE HEAT SEALABLE LIDDING AS MFG IN QUEBEC CANADA(FOILGUARD LF1512SP) POLYESTER ALUMINUM/POLYETYLENE DRUG WRAPPER PRODUCT W/ADHESIVE AS MFG IN LUGO DI VICENZA ITALY COLORANT PRODUCT #506324JEMB AS MFG IN SOMERSET NJ MFG SITE FACILITIES OPERATING PROCEDURES AND PERSONNEL FOR D95 MFG FACILITY LOCATED IN NOTTINGHAM ENGLAND INTERMEDIATE PERG/9 D-6-N-(PROPIONYL)-8B-METHYLTHIOMETHYLERGOLINE AS MFG IN ROZZANO(MI)ITALY TUBULAR GLASS VIALS(TYPE I) AS MFG IN LONDON ENGLAND FOILGUARD LF1515E2Z AS MFG IN QUEBEC CANADA SN-38B-11 INTERMEDIATE COMPOUND AS MFG IN HYOGO SHIZUOKA JAPAN CLAVULANATE POTASSIUM AS MFG IN ROVERETO(TRENTO) ITALY ONE YEAR CHRONIC STUDY OF CHLORPROPHAM IN DOGS AS PERFORMED BYTPS INC IN MT VERNON INDIANA COMPOUND PACKAGING MATERIAL FOR PHARMACEUTICAL USE AS MFG IN SLAGELSE DENMARK TAK-990020 ARTIFICIAL RASPBERRY FLAVOR AS MFG IN TETERBORO NJ TAK-990021 ARTIFICIAL CHERRY FLAVOR AS MFG IN TETERBORO NJ SHINPET 5015W POLYETHYLENE TERPHTHALATE COPOLYESTER AS MFG IN TAOYUAN HSIEN TAIWAN ROC LOVAZA 1 G SOFT GELATIN CAPSULES(OMEGA-3-ACID ETHYL ESTERS, 1 GRAM PAMIDRONIC ACID (ESUB) AS MANUFACTURED IN MUMBAI MAHARASHTRA AND BANGALORE INDIA R-848 ORAL DRUG PRODUCT AS MFG IN ST PAUL MN AND PITHIVIERS CEDEX FRANCE SULFASALAZINE PVP AS MFG IN CHARLES CITY IA QIAGEN NI-NTA AGAROSE AS MFG IN HILDEN, GERMANY NI-NTA SUPERFLOW AS MFG IN HILDEN, GERMANY LACQTENE HD2002SN58U AS MFG IN HARFLEUR FRANCE ALCLOMETASONE DIPROPIONATE AS MFG IN LERMA ENDO MEXICO

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4Q2012EXCEL DMF# 14693 14694 A 14695 14696 14697 14698 14699 14700 14701 14702 A 14703 14704 14705 14706 I 14707 14708 A 14709 A 14710 14711 14712 14713 14714 14715 14716 I 14717 14718 14719 14720 14721 14722 I 14723 14724 A 14725 14726 14727 I I A III III II 2/9/2000 2/9/2000 2/29/2000 I III II 3/2/2000 2/23/2000 A A I A A III II II II IV II 2/10/2000 2/18/2000 2/18/2000 2/21/2000 2/22/2000 2/23/2000 PRETIUM PACKAGING LLC CERBIOS PHARMA SA IROTEC LABORATORIES LTD ALBEMARLE CORP CP KELCO US INC NATIONAL INSTITUTES OF HEALTH/NATIONAL CANCER INSTITUTE DSM RESEARCH ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD POLIMERI EUROPA FRANCE SA POLIMERI EUROPA FRANCE SA KEWPIE CORP A A A A A A II II II II II II III 2/10/2000 2/15/2000 2/29/2000 1/27/2000 12/15/1999 2/1/2000 2/18/2000 WOCKHARDT LTD ERREGIERRE SPA SERIPHARM SA PIRAMAL HEALTHCARE LTD INKE SA PEPTIDO GMBH WINPAK TECHNOLOGIES INC II 2/11/2000 CIPLA LTD I III III 1/28/2000 2/14/2000 NORDEN PACK INTERNATIONAL AB KLOCKNER PENTAPLAST GMBH A I A II II II II 12/20/1999 2/2/2000 2/9/2000 2/10/2000 TEVA PHARMACEUTICAL INDUSTRIES LTD INTERNATIONAL ISOTOPES IDAHO INC EXCELLA GMBH NATURAL PHARMACEUTICALS INC A I A A A A I II II II II II II III II 2/24/2000 2/2/2000 2/3/2000 1/31/2000 2/2/2000 2/2/2000 2/3/2000 2/4/2000 DOW CHEMICAL CO METAFLUX AG EMISPHERE TECHNOLOGIES INC EMBIO LTD DR REDDYS LABORATORIES LTD SUMITOMO SEIKA CHEMICALS CO LTD COLOR MASTER INC COSMA SPA STATUS Type SUBMIT DATE A II II 2/1/2000 2/15/2000 HOLDER FARMABIOS S P A CORDEN PHARMA SWITZERLAND LLC SUBJECT TRIAMCINOLONE ACETONIDE AS MFG IN PAVIA ITALY

4Q2012

1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE(POPC) AS MFG IN LIESTAL SWITZERLAND SEVELAMER HYDROCHLORIDE AS MFG IN MIDLAND MICHIGAN METAFLUX 70-09 BIOLUB(SPRAY) AS MFG IN MOHLIN SWITZERLAND 5-CNAC AS MFG IN MORTON GROVE IL PSEUDOEPHEDRINE SULFATE AS MFG IN MAHARASHTRA INDIA CIPROFLOXACIN USP AS MFG IN ANDHRA PRADESH INDIA B-WING AS MFG IN HYOGO JAPAN MT1161E FDA BRONZE COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN LABETALOL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN CISERANO(BERGAMO) ITALY FLUDROCORTISONE ACETATE AS MFG IN MILAN ITALY STRONTIUM SR-89 CHLORIDE AS MFG IN SCOVILLE IDAHO FLUTAMIDE (ESUB) AS MANUFACTURED IN FEUCHT GERMANY PACLITAXEL API, ISOLATION AND PURIFICATION FROM TAXUS BREVIFOLIA AS MFG IN BOULDER CO PACKAGING MATERIAL FOR NICOTROL INHALER AS MFG IN ASTORP SWEDEN CYCLOOLEFIN MULTILAYER PACKAGING FILMS AS MFG IN, GERMANY THE NETHERLANDS USA AND SWITZERLAND CIPROFLOXACIN HYDROCHLORIDE (ESUB) USP AS MANUFACTURED IN MAHARASHTRA BANGALORE AND MUMBAI INDIA NIZATIDINE USP AS MFG IN ANKLESHWAR INDIA NAFTIFINE HYDROCHLORIDE AS MFG IN BERGAMO ITALY 10-DEACETYL BACCATIN III AS MFG IN LE MANS FRANCE DILTIAZEM HYDROCHLORIDE AS MFG ANDHRA PRADESH INDIA FLUCONAZOLE AS MFG IN CASTELLBISBAL BARCELONA SPAIN LEVOTHYROXINE SODIUM AS MFG IN BEXBACH, GERMANY PACKAGING MATERIAL FOR PHARMACEUTICAL PRODUCTS AS MFG IN TORONTO ONTARIO CANADA PLASTIC PACKAGING MATERIALS AS MFG IN SEYMOUR IN CALCITRIOL DRUG SUBSTANCE AS MFG IN BARBENGO SWITZERLAND FLUTAMIDE AS MFG IN LITTLE ISLAND CORK IRELAND BENAZEPRIL HYDROCHLORIDE AS MFG IN SOUTH HAVEN MI GELLAN GUM GELRITE MK AS MFG IN SAN DIEGO CA PYROXAMIDECMC AND PRECLINICAL PHARMACOLOGY AND TOXICOLOGY DAA AS MFG IN BUFFALO NY AND LEXINGTON MA STAMYLAN P11E10 AS MFG IN GELEEN THE NETHERLANDS SULFASALAZINE AS MFG IN ZHEJIANG CHINA FLEXIRENE FG23F AS MFG IN DUNKIRK FRANCE FLEXIRENE FG20F AS MFG IN DUNKIRK FRANCE SODIUM HYALURONATE AS MFG IN IBARAKI-KEN JAPAN

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4Q2012EXCEL DMF# 14728 14729 14730 14731 14732 14733 I 14734 14735 I 14736 14737 14738 I 14739 I 14740 I 14741 I 14742 14743 14744 14745 I 14746 I 14747 14748 14749 A 14750 14751 I 14752 14753 14754 14755 I 14756 I 14757 14758 14759 I A A II III II 3/6/2000 3/8/2000 3/7/2000 I I I II II II 9/1/1998 9/1/1998 9/1/1998 I II II 2/29/2000 3/8/2000 I I II II II 2/29/2000 3/2/2000 2/29/2000 MEDI CULT A/S PROCOS SPA AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPA SIFAVITOR SPA ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD ABBOTT INDUSTRIES INC FERMIC SA DE CV BIOCHEMICA OPOS SPA ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV DSM MINERA BV STELLA KUNSTSTOFFTECHNIK GMBH MIDORI KAGAKU CO LTD I 2/29/2000 MEDI-CULT A/S I A A II II III III 3/1/2000 2/15/2000 3/1/2000 2/24/2000 MOLECULAR MEDICINE LLC OKAMI CHEMICAL INDUSTRY CO LTD SOFFIERIA BERTOLINI SPA AKZO NOBEL INKS CORP ADENOVIRUS AS MFG IN LA JOLLA CA TROPICAMIDE AS MFG IN KYOTO JAPAN GLASS VIALS AND GLASS AMPOULES AS MFG IN TORINO ITALY III 2/25/2000 COLOR MASTER INC III 2/25/2000 COLOR MASTER INC III 2/25/2000 COLOR MASTER INC I I III III III 3/3/2000 3/3/2000 2/25/2000 COLOR MASTER INC COLOR MASTER INC COLOR MASTER INC I III III 3/3/2000 3/3/2000 COLOR MASTER INC COLOR MASTER INC STATUS Type SUBMIT DATE A C I I I II II II II II III 2/21/2000 2/25/2000 3/14/2000 3/14/2000 2/25/2000 3/3/2000 HOLDER PCAS TEVA PHARMACEUTICAL INDUSTRIES LTD AVENTIS PHARMACEUTICALS INC AVENTIS PHARMACEUTICALS INC SOCIETA ITALIANA MEDICINALI SCANDICCI COLOR MASTER INC SUBJECT CLOMIPHENE CITRATE AS MFG IN LIMAY FRANCE PRAVASTATIN SODIUM AS MFG IN DEBECCEN HUNGARY MDL 105074 AS MFG IN MIDLAND MICHIGAN MDL 104036 AS MFG IN MIDLAND MICHIGAN MESNA AS MFG IN FIRENZE ITALY

4Q2012

BL1886E FDA282C DK BLUE COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN BN1114E FDA DK BROWN COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN GR1579E FDA 332C GREEN COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN RD1369E FDA 2365 PINK COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN RD1640E FDA182C PINK COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN RD1636E FDA PMS 182 PINK COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN BL 1879E FDA PMS282 DK BLUE COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN GR1573E FDA PMS332 GREEN COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN RD1635E FDA PMS2356 PINK COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA IN

WATER BASED PRINTING INK AND UV CURABLE COATING PRODUCTS AS MFG IN PLYMOUTH MN MFG SITE FACILITIES OPERATING PROCEDURES AND PERSONNEL LOCATED IN JYLLINGE DENMARK RENCYTE SYSTEM MEDIA AS MFG IN JYLLINGE DENMARK MONOALDEHYDE AS MFG IN NOVARA ITALY FLECAINIDE ACETATE AS MANUFACTURED IN COMO ITALY (ESUB) TIMOLOL MALEATE AS MFG IN LODI ITALY SULFASALAZINE-PVP AS MFG IN ZHEJIANG CHINA LINCOMYCIN HYDROCHLORIDE MONOHYDRATE BULK GENTAMYCIN SULFATE CEFACLOR BULK NON STERILE

SILVER SULFADIAZINE AS MFG IN MAARSSEN THE NETHERLANDS CHILD PROOF PACKAGING MATERIAL AS MFG ELTVILLE, GERMANY A WINGS AS MFG IN FUKUSHIMA JAPAN

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4Q2012EXCEL DMF# 14760 14761 I 14762 A 14763 14764 14765 14766 14767 14768 14769 14770 14771 14772 14773 14774 14775 14776 14777 A 14778 14779 14780 A 14781 14782 A 14783 A 14784 I 14785 14786 14787 14788 14789 14790 A 14791 I 14792 I II 12/16/1999 II 3/3/2000 CHEMISCHE FABRIK BERG BITTERFELD GMBH MALLINCKRODT INC BUTABARBITAL SODIUM AS MFG IN BITTERFELD GERMANY I I A I A IV II III II III II 3/16/2000 3/16/2000 3/14/2000 4/4/2000 3/23/2000 3/21/2000 II 3/15/2000 II 3/17/2000 A II V 2/29/2000 3/16/2000 TEVA PHARMACEUTICAL INDUSTRIES LTD PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INC JOHNSON MATTHEY PHARMACEUTICAL MATERIALS RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA SPA MYLAN TECHNOLOGIES INC YANGZHOU PHARMACEUTICAL FACTORY CLARIANT(CANADA) INC OXO CHEMIE INC CSP TECHNOLOGIES INC A A II II III 3/14/2000 3/14/2000 3/14/2000 DIVIS LABORATORIES LTD DIVIS LABORATORIES LTD LOPAREX BV A I A I C C A I I I I A I A II III IV II II II II III III III IV II III II III 3/7/2000 2/22/2000 3/3/2000 3/10/2000 3/8/2000 3/3/2000 3/9/2000 12/14/1999 1/28/2000 2/28/2000 2/3/2000 3/15/2000 3/10/2000 3/14/2000 3/13/2000 CHEMI SPA ARDAGH GLASS LIMMARED AB QUALICAPS EUROPE SA XIAN PHARMACEUTICAL FACTORY QUIMICA SINTETICA SA TEVA PHARMACEUTICAL INDUSTRIES LTD LUPIN LTD TARGOR GMBH TARGOR GMBH TARGOR GMBH FONA INTERNATIONAL INC TEVA PHARMACEUTICAL INDUSTRIES LTD ASTRA PLASTIQUE SHANGHAI MEDICINAL LTD CANADA COLORS AND CHEMICALS LTD III 3/9/2000 STATUS Type SUBMIT DATE A III II 2/24/2000 3/3/2000 HOLDER MULLER AND MULLER JOH GMBH CO KG RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA SPA TECH SEAL PRODUCTS INC SUBJECT TUBULAR GLASS INJECTION VIALS AS MFG IN HOLMINDEN, GERMANY

4Q2012

TRAMADOL HYDROCHLORIDE AS MFG IN CAMPOVERDE DI APRILIA LATINA ITALY CLOSURE LINERS AND CONTAINER INNER INNER SEALS AS MANUFACTURED IN TRIADELPHIA, WV LEUPROLIDE ACETATE AS MFG IN PATRICA(FROSINONE)ITALY AMBER GLASS CONTAINERS AS MFG IN LIMMARED SWEDEN HYPROMELLOSE CAPSULES AS MANUFACTURED IN ALCOBENDAS-MADRID, SPAIN CLARITHROMYCIN AS MFG IN XIAN SHAANXI PR CHINA OFLOXACIN AS MFG IN MADRID SPAIN BROMOCRIPTINE MESYLATE AS MFG IN OPAVA CZECH REPUBLIC CEFUROXIME AXETIL CRYSTALLINE AS MFG IN INDIA THAILAND AND PUERTO RICO NOVOLEN 3270H AS MFG IN GERMANY AND SPAIN NOVOLEN 2670PC AS MFG IN GERMANY AND THE NETHERLANDS NOVOLEN 3278TC AS MFG IN GERMANY AND SPAIN 926.016 LIQIUD NOR-VAN(AN ARTIFICIAL FLAVOR) AS MFG IN CAROL STREAM IL LISINOPRIL DRUG SUBSTANCE AS MFG IN GUAYAMA PUERTO RICO PACKAGING MATERIAL ASW MFG IN SAINT-GEORGES DE RENEINS FRANCE METFORMIN HYDROCHLORIDE AS MFG IN SHANGHAI CHINA AMBER MB 20-3731 POLYETHYLENE COLOR CONCENTRATE AS MFG IN COLBORNE ONTARIO CANADA A WINGS AS MFG IN ANDHRA PRADESH INDIA B WINGS AS MFG IN ANDHRA PRADESH INDIA FL2000 75MCG PET C1S WITH GRADE CODE 78BT AS MFG IN APELDOORN THE NETHERLANDS ERGOLOID MESYLATES AS MFG IN OPAVA CZECH REPUBLIC BUILDING 41 ASEPTIC FACILITY UPGRADE DEXTROAMPHETAMINE SULFATE AS MFG IN WEST DEPTFORD NJ LOVASTATIN AS MFG IN LATINA ITALY PIB ADHESIVE AS MFG IN ST ALBANS VT FELODIPINE AS MFG IN YANGZHOU JIANGSU CHINA 01PPP-14 WHITE MASTERBATCH AS MFG IN MISSISSAUGA ONTARIO CANADA OXO-K993 AS MFG IN WANZLEBEN, GERMANY MODIFIED THERMOPLASTIC PACKAGING PRODUCTS AS MFG IN AUBURN ALABAMA

ZHEJIANG HISUN PHARMACEUTICAL CO LTD FLOXURIDINE AS MFG IN ZHEJIANG PROVINCE CHINA

NOSCAPINE USP SMALL CRYSTALS AND NOSCAPINE HYDROCHLORIDE PURIFIED AS MFG IN ST LOUIS MISSOURI

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4Q2012EXCEL DMF# 14793 14794 14795 I 14796 14797 I 14798 A 14799 14800 I 14801 A 14802 A 14803 14804 A 14805 14806 14807 A 14808 14809 14810 14811 14812 14813 14814 14815 14816 14817 14818 I 14819 14820 I 14821 I 14822 I III 3/5/2000 IMBC BLOWMOLDING INC III 4/7/2000 SKC INC A IV II 3/27/2000 4/27/2000 UNGERER AND CO NIDARIA TECHNOLOGY LTD A A I I A A A A I I IV II II II II II III III II II III 3/27/2000 3/31/2000 4/3/2000 3/31/2000 3/31/2000 3/31/2000 3/29/2000 3/29/2000 4/4/2000 3/31/2000 3/29/2000 UNGERER AND CO SANOFI CHIMIE TOYAMA CHEMICAL CO LTD ASUBIO PHARMA CO LTD SHIONO FINESSE LTD ANTIBIOTICE SA 3M DRUG DELIVERY SYSTEMS 3M DRUG DELIVERY SYSTEMS ASTELLAS PHARMA GMBH TORONTO RESEARCH CHEMICALS INC AMPACET CORP A A III III II 3/29/2000 3/27/2000 3/29/2000 I IV II 3/29/2000 3/23/2000 II 3/22/2000 II 3/24/2000 ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD PRIME EUROPEAN THERAPEUTICS SPA EUTICALS SPA WILD FLAVORS INC ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTD TOSOH CORP INEOS ABS USA CORP CATALENT PHARMA SOLUTIONS LLC I III III 3/27/2000 3/27/2000 PREGIS CORPORATION PREGIS CORPORATION V 3/28/2000 I II II 3/28/2000 3/27/2000 DEGUSSA-HULS AG ZHEJIANG TAIZHOU HISOAR PHARM CHEM CO LTD MALLINCKRODT LLC STATUS Type SUBMIT DATE A A II II III 3/27/2000 1/19/2001 3/17/2000 HOLDER ACS DOBFAR SPA INFA SA ACLO COMPOUNDERS INC SUBJECT CEFAMANDOLE NAFATE AS MFG IN MILAN ITALY KETOCONAZOLE AS MFG IN ALCANTARILLA, MURCIA, SPAIN

4Q2012

40% MINERAL(TALC)FILLED ISOTATIC HOMOPOLYPROPYLENE PACKAGING MATERIAL AS MFG IN CAMBRIDGE ONTARIO CANADA IFOSFAMIDE CRUDE AS MFG IN RADEBEUL GERMANY CLINDAMYCIN PHOSPHATE AS MFG IN ZHEJIANG CHINA MALLINCKRODT INC-MARYLAND HEIGHTS PARAMETRIC RELEASE PROGRAM (ESUB) IN MARYLAND HEIGHTS MISSOURI PROPYFLEX AS MFG IN HALLE/WESTFALEN FEDERAL REPUBLIC OF GERMANY FLAT PA175 CLOSED PART AS MFG IN HALLE/WESTFALEN FEDERAL REPUBLIC OF GERMANY LISINOPRIL DIHYDRATE(BULK) AS MFG IN ZHEJIANG PROVINCE PR OF CHINA MINOCYCLINE HYDROCHLORIDE AS MFG IN ORIGGIO(VA)ITALY ARTIFICIAL SWEETNESS FLAVOR #FADF421 AS MFG IN ERLANGER KY NABUMETONE(BULK)AS MFG IN XIANJU ZHEJIANG PROVINCE PR OF CHINA PETROTHENE 175K PACKAGING MATERIAL AS MFG IN YOKKAICHISI MIE JAPAN LUSTRAN ABS 248FC PACKAGING MATERIAL AS MFG IN ADDYSTON & HEBRON OH LOPINAVIR/RITONAVIR 133.3/33.3MG SOFT GELATIN CAPSULES AS MFG IN ST PETERSBURG FL ART GRAPE FLVP FH-1035 AS MFG IN LINCOLN PARK NJ CLOPIDOGREL BISULFATE FORM II AS MFG IN ARAMON FRANCE T-588 DRUG SUBSTANCE AS MFG IN OSAKA JAPAN SUN N4057 DRUG SUBSTANCE AS MFG IN GUNMA JAPAN KAD-1229 DRUG SUBSTANCE AS MFG IN FUKUI JAPAN NYSTATIN AS MFG IN IASI ROMANIA A66007 SPRAYMISER VALVE AS MFG IN GREAT BRITAIN A66200 SPRAYMISER VALVE AS MFG IN GREAT BRITAIN FK-866 DRUG SUBSTANCE AS MFG IN OSAKA JAPAN L-METHIONINE SULFOXIMINE AS MFG IN TORONTO ONTARIO CANADA 7012276 SLIP AB LDPE MB POLYETHYLENE MASTERBATCHAS MFG IN TERRE HAUTE,INDIANA; DERIDDER,LOUISIANA; CARTERSVILLE,GEORGIA; HEATH,OHIO; LATEXO,TEXAS. ART GRAPE BASE 42483 AS MFG IN LINCOLN PARK NJ PLANKTON BLOCKING TECHNOLOGY (PBT) EXTRACT AS MFG IN KINAROT, ZEMACH, JORDAN VALLEY, ISRAEL SKYROL PET FILMS FOR PACKAGING DRUG PRODUCTS AS MFG IN COVINGTON GA AND KYONGGI-DO KOREA PLASTIC BOTTLES FOR PHARMACEUTICAL USE AS MFG IN ORANGEVILLE ONTARIO CANADA

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4Q2012EXCEL DMF# 14823 A 14824 A 14825 14826 14827 14828 I 14829 14830 14831 A 14832 A 14833 14834 14835 14836 14837 A 14838 I 14839 14840 A 14841 14842 14843 I 14844 A 14845 14846 14847 14848 14849 I 14850 14851 14852 14853 I A I C II II II II 4/25/2000 4/28/2000 4/28/2000 4/27/2000 A I A A II I II II II 5/8/2000 5/8/2000 5/5/2000 4/26/2000 5/4/2000 NITTO DENKO CORP JUNGBUNZLAUER LADENBURG GMBH JUNGBUNZLAUER LADENBURG GMBH ISP CHEMICALS LLC III 3/10/2000 I A II II V 4/20/2000 4/20/2000 3/10/2000 SIFAVITOR SRL CEDARBURG PHARMACEUTICALS INC MEDIS LABORATORIES MEDICAMENTS STERLIES - S.A. TICONA LLC A II III 4/24/2000 4/14/2000 IDT AUSTRALIA LTD LOPAREX LLC I 4/13/2000 MOUNT SINAI MEDICAL SCH I A A A II II II IV II 4/14/2000 4/12/2000 4/14/2000 4/14/2000 4/17/2000 IV 4/12/2000 I I III II II 3/30/2000 4/14/2000 4/10/2000 BESPAK PLC DEGUSSA HULS AG WERK RADEBEUL AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPA GLATFELTER GERNSBACH GMBH AND CO KG DIOSYNTH BV FARCHEMIA SRL CATALENT PHARMA SOLUTIONS LLC KERRY INGREDIENTS AND FLAVOURS CORDEN PHARMA SWITZERLAND LLC I I I III III III III 5/4/2000 3/31/2000 4/10/2000 4/12/2000 III 4/5/2000 VETTER PHARMA FERTIGUNG GMBH AND CO KG KUREHA CHEMICAL INDUSTRY CO LTD AKZO NOBEL INKS CORP PACKAGING COORDINATORS, INC. REXAM PHARMA DIVISION STATUS Type SUBMIT DATE IV 4/11/2000 HOLDER BASF CORP SUBJECT

4Q2012

KOLLICOAT MAE 30DP AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY V-OVS SYSTEM 10.6 DRUG PACKAGING MATERIAL AS MFG IN RAVENSBURG, GERMANY KREHALON LATEX DO702 & DO703 AS MFG IN FUKUSHIMA, JAPAN UV CURABLE PRINTING INKS AS MFG IN PLYMOUTH MN PHARMACEUTICAL PACKAGING PRODUCTS AS MFG IN PHILADELPHIA PA PACKAGING FOR HUMAN DRUGS AND BIOLOGICS AS MFG IN WHEELING AND BUFFALO GROVE IL FOREST AEROBID HFA SPACER INHALER AS MFG IN APEX NC CYCLOPHOSPHAMIDE AS MFG IN RADEBEUL GERMANY DICLOFENAC HYDROXY ETHYL PERROLIDINE (ESUB) AS MANUFACTURED IN COMO ITALY DYNAPORE LONG FIBRE PAPER 026 AS MFG GERNSBACH, GERMANY BOVINE INSULIN HIGHLY PURIFIED AS MFG IN SERIFONTAINE FRANCE HYDROUS BENZOYL PEROXIDE AS MFG IN TREVIGLIO(BERGAMO)ITALY ZARONTIN 0.25G SOFT GELATIN CAPSULES AS MFG IN ST PETERSBURG FL NATURAL BANANA FLAVOR WONF 080-0029R LIQUID AS MFG IN CINCINNATI OH 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL,SODIUM SALT(DPPG,NA) AS MFG IN LIESTAHL SWITZERLAND MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES, AND PERSONNEL FOR THE 17TH FLOOR OF ANNENBERG BUILDING HEMATOPORPHYRIN DIACETATE AS MFG IN BORONIA, VICTORIA, AUSTRALIA GRADE 15787 3MIL CL PET 92A/000 SILICONE COATED RELEASE LINER AS MFG IN IOWA CITY, IA; EDEN,NC. SOTALOL HYDROCHLORIDE AS MANUFACTURED IN LODI, ITALY BUTORPHANOL TARTRATE AS MFG IN GRAFTON, WISCONSIN STERILE PROCESSING FACILITY LOCATED IN NABEUL, TUNISIA FORTRON POLYPHENYLENE SULFIDE AS MFG IN WILMINGTON, NC; FLORENCE, KY; SHELBY,NC; SHROPSHIRE, UK AG-AS ACTIVE PHARMACEUTICAL INGREDIENT MANUFACTURED IN MILFORD, MA MANUFACTURING, FACILITIES, OPERATING PROCEDURES AND PERSONNAL TRIPOTASSIUM CITRATE AS MANUFACTURED IN LADENBURG, GERMANY BORONIC ACID INTERMEDIATE (BAI) AS MANUFACTURED IN COLUMBUS OHIO

CHINOIN PHARMACEUTICAL AND CHEMICAL CLOPIDOGREL BISULFATE FORM I WORKS LTD SAFC BIOSCIENCES INC EX-CELL PF CHO MEDUIM (MODIFIED), CATALOG NO. 62625 AS MFG IN DENVER,PA. HOSPIRA INC SANOFI CHIMIE MITSUI CHEMICALS,INC. OFNE ADMIXTURE DRUG PRODUCTS DESOXIMETASONE USP, MICRONIZED, MFG IN VERTOLAYE, FRANCE MS-275 (N-(2-AMINOPHENYL)-4-[N-(PYRIDIN-3-YLMETHOXYCARBONYL)AMINOMETHYL]BENZAMIDO) MANUFACTURED IN CHIYODAKU, TOKYO, JAPAN

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4Q2012EXCEL DMF# 14854 A 14855 14856 14857 14858 14859 14860 14861 14862 14863 14864 14865 14866 14867 I 14868 14869 14870 I 14871 14872 14873 14874 I 14875 I 14876 I 14877 14878 14879 14880 14881 A 14882 A 14883 14884 14885 14886 14887 14888 I A A I I I II II III II III II 5/19/2000 5/15/2000 5/10/2000 5/16/2000 5/5/2000 11/5/1996 II 5/19/2000 I I I I III III III III III 5/1/2000 5/1/2000 5/1/2000 5/1/2000 5/14/2000 COLOR MASTER, INC. COLOR MASTER INC COLOR MASTER, INC. COLOR MASTER, INC. TOTAL PETROCHEMICALS RESEARCH FELUY SA VERTELLUS AGRICULTURE NUTRITION SPECIALTIES LLC NANOSYSTEMS DAIICHI SANKYO EUROPE GMBH TOURNAIRE OMNICHEM NV LUDLOW COATED PRODUCTS BILCARE INC IV 5/11/2000 METAROM CANADA INC. III 5/3/2000 I I I IV III IV II 5/8/2000 5/9/2000 5/8/2000 5/10/2000 FONA INTERNATIONAL INC SONOCO FLEXIBLE PACKAGING FONA INTERNATIONAL INC OPOCRIN LABORATORIO FARMACOBIOLOGICA KUNSTSTOFFWERK MAUER GMBH I I III IV II 4/26/2000 5/8/2000 5/5/2000 AKZO NOBEL INKS CORP FONA INTERNATIONAL INC AVIGEN INC I I I I I I I I I I A I II IV IV IV IV IV IV IV II II II II II 4/28/2000 4/25/2000 4/25/2000 4/25/2000 4/25/2000 4/25/2000 4/25/2000 4/28/2000 5/2/2000 3/31/2000 6/12/2000 5/4/2000 5/8/2000 INFAR S.A. FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FMC CORP SPECIALTY DIV WOCKHARDT LTD WORLD MINERALS INCORPORATED SAMCHULLY PHARMACEUTICAL CO LTD YANTAI NO.2 PHARMACEUTICAL FACTORY R.P. SCHERER NORTH AMERICA STATUS Type SUBMIT DATE II 4/25/2000 HOLDER SAFC BIOSCIENCES INC SUBJECT

4Q2012

EX-CELL 610 HSF HYBRIDOMA, SERUM-FREE MEDUIM. CATALOG NO. 14610 AS MFG IN DENVER,PA. 5-AMINOSALICYLIC ACID #929.125 WATERMELON FLAVOR, ARTIFICIAL #915.791 STRAWBERRY BANANA FLAVOR ARTIFICIAL #906.440 BLUE RASPBERRY FLAVOR, ARTIFICIAL (ALCOHOL FREE) #889.013 ARTIFICIALFRESH PEACH FLAVOR #884.655 ORANGE CREME FLAVOR EMULSION, NATURAL & ARTIFICIAL #936.589 COTTON CANDY FLAVOR, ARTIFICIAL (ALCOHOL FREE) LUSTRECLEAR MICROCRYSTALLINE CELLULOSE/CARRAGEENAN-BASED COATING. FLUCONAZOLE AS MFG IN GUJARAT STATE, INDIA CHROMOSORB P-AW 100/120 MANUFACTURED IN LOMPOC CA ACYCLOVIR DRUG SUBSTANCE AS MFG IN KYUNGGI-DO, KOREA GENTAMICIN SULFATE AS MFG IN SHANDONG PROVINCE, P.R. CHINA HECTOROL, 1.0 MICROG SOFT GELATIN CAPSULES MANUFACTURED IN ST. PETERSBURG, FL WATER-BASED PRINTING INK PRODUCTS ; UV-CURABLE PRINTING INK PRODUCTS #825.083 ARTIFICIAL BLACK CHERRY FLAVOR ADENO-ASSOCIATED VIRUS (AAV) VECTOR CONTAINING THE GENE FOR HUMAN BLOOD COAGULATION FACTOR IX (COAGULIN-B) AS MFG IN ALMEDA CALIFORNIA #856.150 ARTIFICIAL CONCORD GRAPE FLAVOR SFP003M-4 LAMINATED PACKAGING MATERIAL AS MFG IN EDINBURGH, IN #936.451 MOUTH SALVATION FLAVOR, ARTIFICIAL SULODEXIDE AS MANUFACTURED IN CORLO (MODENA) ITALY PLASTIC PACKAGING PRODUCTS AS MFG IN UBSTADT-WEIHER, FEDERAL REPUBLIC OF GERMANY COTTON CANDY ARTIFICIAL FLAVOR ; ORANGE CREAMSICLE N&A FLAVOR; BLUERASPBERRY N&A FLAVOR ; WATERMELON N&A FLAVOR. MT1164E, FDA SILVERCOLOR CONCENTRATE FOR PLASTICS BL1911 E, TRANSPARENT BLUECOLOR CONCENTRATE FOR PLASTICS BK1101E, FDA BLACKCOLOR CONCENTRATE FOR PLASTICS YL1322E, FDA V. YELLOW COLOR CONCENTRATE FOR PLASTICS RANDOM COPOLYMER POLYPROPYLENE PPM R021 NIACINAMIDE USP AS MFG IN INDIANAPOLIS IN N1106 (VX-745) ORAL NANOCRYSTAL CAPSULES (125MG) AS MFG IN HORSHAM PA CS-866(5 10 20 & 40MG) TABLETS AS MFG IN PFAFFENHOFEN, GERMANY ALUMINUM CONTAINER-CLOSURE SYSTEMS AS MFG IN GRASSE CEDEX FRANCE DIPYRIDAMOLE USP AS MFG IN BALEN, BELGIUM #60063-58 PACKAGING PRODUCT AS MFG IN COLUMBUS OHIO ENCAPSULATION PROCESS AS PERFORMED AT PHOENIXVILLE, PA

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4Q2012EXCEL DMF# 14889 A 14890 14891 14892 14893 A 14894 14895 14896 A 14897 14898 14899 14900 A 14901 I 14902 14903 A 14904 I 14905 14906 14907 14908 14909 I 14910 14911 A 14912 14913 A 14914 14915 A 14916 A 14917 I 14918 I I 5/26/2000 SHENZHAN (CHINA) NEPTUNUS PHARMACEUTICAL CO., LTD. III 6/5/2000 II 6/12/2000 BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI SPA AMPACET CORP I II II 6/6/2000 6/8/2000 MEIJI SEIKA KAISHA, LTD. CYALUME SPECIALTY PRODUCTS INC A II II 6/5/2000 6/1/2000 BIOCON LTD AESICA PHARMACEUTICALS LTD A II III 6/1/2000 5/25/2000 CADILA HEALTHCARE LTD ECLATIN AG I I I I II II II II III 5/22/2000 5/31/2000 5/31/2000 6/2/2000 6/2/2000 WOCKHARDT LTD BIDACHEM S.P.A. MOEHS IBERICA SL IRVINE SCIENTIFIC SALES COMPANY VANGUARD PLASTICS III 6/5/2000 A III III 5/19/2000 5/19/2000 TOTAL PETROCHEMICALS BERRY PLASTICS CORP TAPES AND COATINGS DIV JAPAN POLYOLEFINS CO., LTD. III 5/19/2000 RADEMATE LTD. I A I III III II II 5/19/2000 5/8/2000 5/26/2000 5/25/2000 ALVEO AG SUMITOMO RUBBER INDUSTRIES LTD FUJISAWA PHARMACEUTICAL CO., LTD. TAMA KAGAKU KOGYO CO LTD I I II II III 5/26/2000 5/15/2000 5/19/2000 A A I II IV II II 5/8/2000 5/16/2000 5/12/2000 5/19/2000 DR REDDYS LABORATORIES EU LTD ROQUETTE FRERES DAIICHI PHARMACEUTICAL CO LTD ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD AVANTI POLAR LIPIDS INC LONZA BIOTEC SRO STELLA KUNSTSTOFFTECHNIK GMBH STATUS Type SUBMIT DATE III 5/10/2000 HOLDER AMPACET CORP SUBJECT

4Q2012

11748-SP WHITE POLYETHYLENE MASTERBATCHAS MFG IN TERRE HAUTE,INDIANA; DERIDDER,LOUISIANA; CARTERSVILLE,GEORGIA; HEATH,OHIO; LATEXO,TEXAS. TRAVOPROST AS MFG IN STEVENAGE HERTS UNITED KINGDOM MANNITOL, SPRAY DRIED USP GRADE, (PEARLITOL(R) AS MGF IN LESTERM FRANCE DE-310 DRUG SUBSTANCE AS MFG IN EDOGAWA-KU TOKYO JAPAN CARBAMAZEPINE USP MANUFACTURED IN ZHEJIANG PROVINCE, CHINA DIMETHYLDIOCTADECYLAMMONIUM BROMIDE AS MFG IN ALABASTER, ALABAMA L-CARNITINE DIR AS MANUFACTURED IN KOURIM, CZECH REPUBLIC PROTECAP, CHILD-RESISTANT CLOSURE; STELLA-ARTICLE 6-5268-01-01 AS MFG IN ELTVILLA, GERMANY ALVEOLIT TA S WHITE AS MFG IN LUZERN, SWITZERLAND RUBBER CLOSURE AS MFG IN OSAKA, JAPAN FK 788 DRUG SUBSTANCE AS MFG IN OSAKA, JAPAN 2-HYDROXYMETHY1-4-(3-METHOXYPROPOXY)-3-METHYLPYRIDINE AS MFG IN SAITAMA, JAPAN RAPID BIODEGRADABLE HYDROPHOBIC MATERIAL RBHM, MANUFACTURED IN TEIC, SCIENCE PARK TECHNION, NESHER HAIFA, ISRAEL PP HOMOPOLYMER APPRYL 3250 MR1 MANUFACTURED IN LAVERA, FRANCE ALVEOLIT TA AS MFG IN LUZERN, SWITZERLAND POLYETHYLENE FOR USE IN DRUG PACKAGING AS MFG IN OITA PREFECTURE, AND KANAGAWA PREFECTURE JAPAN CIPROFLOXACIN HYDROCHLORIDE, USP AS MFG IN GUJARAT STATE, INDIA METHOCARBAMOL AS MFG IN GLOVANNI, ITALY METOPROLOL TARTRATE USP AS MFG IN RUBI, SPAIN MODIFIED IS-CHO AS MFG IN SANTA ANA, CA. PLASTIC CONTAINERS UTILIZING THE EXTRUSION BLOW MOLDING PROCESS AS MFG IN ALLENTOWN, PA DEFERIPRONE AS MFG IN DABHASA, GUJARAT, INDIA INTERNAL LACQUERS FOR TUBES AND AIROSOLS V-5266 AND V-5266/A-2093 AS MFG IN SOLOTHURN, AWITZERLAND LOVASTATIN USP AS MFG IN BANGALORE, INDIA PAROXETINE HYDROCHLORIDE AS MFG IN NORTHUMBERLAND, GREAT BRITAIN; LUDWIGSHAFEN, GERMANY TAPORFIN SODIUM DRUG SUBSTANCE AS MFG IN TOKYO, JAPAN GLUCOSAPURE (GLUCOSAMINE SULFATE) AS MFG IN BOUND BROOK, NJ; ALBANY, OREGON. TERAZOSIN HCL. 2H2O AS MFG IN FRESONARA AL, ITALY 100323 ANTISTAT POLYETHYLENE MASTERBATCH AS MFG IN TERRE HAUTE,INDIANA; DERIDDER,LOUISIANA; CARTERSVILLE,GEORGIA; HEATH,OHIO; LATEXO,TEXAS. MFG FACILITIES, OPERATING PROCEDURES, AND PERSONEL FOR PRODUCTION FACILITY LOCATED IN NANSHAN DISTRICT, SHENZHEN, GUANGDONG, CHINA

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4Q2012EXCEL DMF# 14919 I 14920 I 14921 A 14922 14923 A 14924 14925 I 14926 14927 14928 14929 I 14930 14931 14932 14933 I 14934 I 14935 I 14936 I 14937 A 14938 14939 14940 14941 A 14942 A 14943 14944 14945 14946 14947 14948 A A I I A I III II II II II II 5/5/2000 6/28/2000 8/21/2000 7/3/2000 6/29/2000 6/30/2000 II 6/26/2000 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA BERRY PLASTICS CORP TEVA PHARMACEUTICAL INDUSTRIES LTD TAKEHARA KAGAKU KOGYO CO LTD A.M.S.A. S.P.A. ERREGIERRE SPA NAPP TECHNOLOGIES INC I A I II IV II II 6/30/2000 7/12/2000 7/3/2000 7/3/2000 CHEM SOURCE CORP SHIONO FINESSE, LTD. CATALENT PHARMA SOLUTIONS LLC IV 6/20/2000 II 6/22/2000 NORTHEAST GENERAL PHARMACEUTICAL FACTORY WACKER CHEMIE AG III 6/14/2000 COLOR MASTER INC III 6/19/2000 A I A II II III IV 6/21/2000 6/15/2000 6/26/2000 6/19/2000 SAFC BIOSCIENCES INC HYBRIDON INC ZEON CORP TECHNOLOGY FLAVORS & FRAGRANCES, INC. COLOR MASTER INC I A A II III II II 6/18/2000 6/15/2000 6/19/2000 6/20/2000 AVANTI POLAR LIPIDS INC EAGLE STAINLESS CONTAINER CAMBREX CHARLES CITY INC NANO SYSTEMS I II II 6/15/2000 6/18/2000 BAYER SCHERING PHARMA AG AVANTI POLAR LIPIDS INC I II II 6/15/2000 6/16/2000 SANKYO CO., LTD. 3M DRUG DELIVERY SYSTEMS CS-505 DRUG SUBSTANCE AS MFG IN KANAGAWA, JAPAN II 5/4/2000 II 6/20/2000 LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO CKD BIO CORP STATUS Type SUBMIT DATE III 6/6/2000 HOLDER NATIONAL PAPER & PACKAGING INC. SUBJECT

4Q2012

GLASS CONTACTS: U-S-P TYPE 3 GLASS AS MFG IN SAN ANDRES ATOTO, NAUCALPAN, MEXICO. CEPHALEXIN MONOHYDRATE BULK AS MFG IN MAYAGUEZ, PUERTO RICO LOVASTATIN, NON-STERILE BULK, USP AS MFG IN ANSAN-CITY, KYEONGKI-DO, KOREA

ESTRADIOL/LEVONORGESTREL TRANSDERMAL DELIVERY SYSTEM AS MFG IN ST. PAUL, MN. FLUDARABINE PHOSPHATE AS MFG IN BERLIN, GERMANY 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE(DPPE) AS MFG IN ALABASTER, AL. DC-30 LIPID BLEND AS MFG IN ALABASTER, AL. EAGLE STAINLESS CONTAINER AS MFG IN WARMINSTER, PA. OFLOXACIN USP AS MFG IN CHARLES CITY, IA CELECOXIB 200 MG FILM COATED TABLETS AS MFG IN HORSHAM, PA.; COUNTY WESTMEAH, IRELAND EX-CELL 302 MEDIUM (GS MODIFIED), CATALOG NO. 62639 AS MFG IN DENVER, PA. G3139 ACTIVE PHARMACEUTICAL INGREDIENT AS MFG IN MILFORD MA ZEONOR 750R (CYCLOOLEFIN POLYMER) AS MFG IN OKAYAMA, JAPAN ARTIFICIAL CHERRY FLAVOR BRY-63 AS MFG IN AMITYVILLE, N.Y. BN1025M, FDA TRANSPARENT AMBER COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA, IN. BL1918E, PEARL MAG BLUE COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA, IN. RIMANTADINE HYDROCHLORIDE, NON-STERILE BULK DRUG SUBSTANCE CW-100 AS MFG IN SHENYANG, CHINA ALPHA-CYCLODEXTRIN.A DRUG SUBSTANCE INTERMEDIATE USED IN THE PREPARATION OF A DRUG PRODUCT AS MFG IN EDDYVILLE, IOWA. ENALAPRIL MALEATE DRUG SUBSTANCE AS MFG IN GUAYAMA, PR. TROPICAMIDE AS MFG IN FUKUI, JAPAN PROMETRIUM 100-MG AND 200-MG SOFT-GELATIN CAPSULE AS MFG IN ST. PETERSBURG, FL. PYRIDOXAL-5-PHOSPHATE AS MFG IN CAMPOVERDE DI APRILIA-LT (ITALY) 11176-40 AS MFG IN COLUMBUS, GA. DIHYDROERGOTAMINE MESYLATE AS MFG IN CZECH REPUBLIC U-CAL SSS CALCIUM CARBONATE AS MFG IN HIROSHIMA, JAPAN CARTEOLOL HYDROCHLORIDE AS MFG IN COMO, ITALY BISACODYL USP- PH. EUR. AS MFG IN BERGAMO, ITALY KETOCONAZOLE USP AS MFG IN JALISCO, MEXICO

HENRY H OTTENS MANUFACTURING CO INC NATURAL & ARTIFICIAL CITRUS FLAVOR # 9185 AS MFG IN PHILADELPHIA, PA.

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4Q2012EXCEL DMF# 14949 A 14950 14951 14952 14953 14954 14955 A 14956 14957 14958 I 14959 I 14960 14961 I 14962 14963 I 14964 14965 14966 A 14967 A 14968 A 14969 14970 A 14971 14972 14973 14974 14975 A 14976 I 14977 14978 14979 A I A II II II 8/1/2000 9/6/2000 7/26/2000 CADILA HEALTHCARE LTD ELAN PHARMACEUTICAL RESEARCH CORP LUSOCHIMICA SPA II 7/28/2000 CHEMI SPA A A A A II II II II IV 7/19/2000 7/31/2000 7/27/2000 8/4/2000 7/31/2000 PROCOS SPA ERREGIERRE SPA BIOCHEM CORP FARMASTUR 2010 SL MITSUBISHI CHEMICAL CORP I II II 7/31/2000 7/31/2000 III 8/2/2000 II 7/20/2000 I I II II II 7/25/2000 7/25/2000 7/25/2000 BOSTON BIOSYSTEMS DSM FINE CHEMICALS GERMANY GMBH 3M DRUG DELIVERY SYSTEMS EPI-2010 DRUG SUBSTANCE AS MFG IN BEDFORD, MA FLOXURIDINE AS MFG IN REGENSBURG, GERMANY I II II 8/2/2000 7/19/2000 A II II 7/25/2000 7/27/2000 II 7/28/2000 I A II III II 7/19/2000 7/18/2000 7/20/2000 DIOSYNTH BV BILCARE LTD WL GORE AND ASSOC INC A A I A I III II II II II II 7/11/2000 7/13/2000 7/13/2000 7/14/2000 7/18/2000 9/19/2000 ALVEO AG NEULAND LABORATORIES LTD HEALTH RESEARCH INC DAIICHI SANKYO PROPHARMA CO LTD DAIICHI PHARMACEUTICAL CO LTD KANEKA AMERICA CORP ALVEOLIT TL S AS MFG IN LUZERN, SWITZERLAND SOTALOL HYDROCHLORIDE AS MFG IN ANDHRA PRADESH, INDIA STATUS Type SUBMIT DATE III 7/7/2000 HOLDER GERRESHEIMER BUNDE GMBH SUBJECT

4Q2012

DISPOSABLE ALL GLASS SYRINGE SYSTEMS READY TO FILL (RTF) AS MFG IN GERMANY.

HUMAN PARAHYROID HORMONE, SYNTHETIC [SPTH(1-34)] AS MFG IN TORRANCE, CA. CS-866 DRUG SUBSTANCE AS MFG IN ODAWARA, KANAGAWA PREFECTURE, JAPAN. DX-8951F DRUG SUBSTANCE AS MFG IN HARRISONVILLE, MISSOURI N-2-[1-(S)-ETHOXYCARBONYL]-N-6-TRIFLUOROACETYL-1-LYSYL-N-2-CARBOXY ANHYDRIDE(EPTL) AS MFG IN FUKUSHIMA, JAPAN HEPARIN SODIUM AS MFG IN OSS, THE NETHERLANDS BILCARE PVDC COATED PVC FILM AS MFG IN MAHARASHTRA, INDIA

GORE FLUOROELASTOMER PERISTALTIC PUMP TUBE AS MANUFACTURED IN ELKTON, MD SMITHKLINE BEECHAM PHARMACEUTICALS TICARCILLIN DISODIUM AS MFG IN PISCATAWAY, NJ FP1005 BAYER PHARMA AG ETHINYLESTRADIOL-B-CYCLODEXTRIN-CLATHRATE AS MFG IN BERLIN, GERMANY SMITHKLINE BEECHAM PHARMACEUTICALS TICARCILLIN MONOSODIUM AS MFG IN PISCATAWAY, NJ FP1005 SMLX TECHNOLOGIES INC INSULIN (HUMULIN) TRANSDERMAL PACHES AS MFG IN HOLLANDALE, FLORIDA NINGBO RENJIAN PHARMACEUTICAL CO LTD HMG (HUMAN MENOPAUSAL GONADOTROPHIN) AS MFG IN CIXI NINGBO, CHINA

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG MARUTANI CHEMICAL PLANT ENGINEERING MK DESSICANT AS MFG IN IBARAKI-KEN, JAPAN CO LTD SANYO FINE CO LTD OMEPRAZOLE AS MFG IN HYOGO PREFECTURE, JAPAN CORDEN PHARMA SWITZERLAND LLC

TRANSDERMAL DELIVERY SYSTEM CONTAINING FENTANYL AS MFG IN 3M CENTER, ST. PAUL, MN TROSPIUM CHLORIDE AS MFG IN INGELHEIM AM RHEIN, GERMANY

1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DSPC) AS MFG IN LIESTAL, SWITZERLAND ORPHENADRINE CITRATE AS MFG IN VIA LEONARDO DA VINCI, VIA MATTEOTTI, ITALY SULCONAZOLE NITRATE USP AS MFG IN BERGAMO, ITALY PROTAMINE SULFATE AS MFG IN SAITAMA-KEN, JAPAN SULBACTAM SODIUM USP AS MFG IN SILVOTA, ASTURIAS, SPAIN EXCIPIENTS SUCROSE FATTY ACID ESTERS(SUCROSE STEARIC ACID ESTERS, SUCROSE PALMITIC ACID ESTERS AND SUCROSE LAURIC ACID ESTERS) AS MFG IN YOKKAICHI, MIE PREFECTURE, JAPAN 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL AMMONIUM SALT 95% POSITIONAL PURITY AS MFG PATRICIA(FROSIONE), ITALY HYDROXYCHLOROQUINE SULFATE AS MFG IN PADRA (GUJARAT), INDIA FAMPRIDINE SR TABLETS AS MFG IN COUNTY WESTMEATH, IRELAND NIMODIPINE AS MFG IN LOMAGNA (LC), ITALY

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4Q2012EXCEL DMF# 14980 14981 I 14982 14983 14984 14985 14986 14987 14988 14989 14990 I 14991 14992 14993 14994 14995 14996 14997 I 14998 14999 15000 15001 15002 I 15003 A 15004 15005 15006 15007 I 15008 A 15009 15010 15011 15012 15013 15014 N A I A A A II II III II II 8/18/2000 8/22/2000 9/20/2000 8/24/2000 10/2/2000 NOT AN ASSIGNED NUMBER SAFC BIOSCIENCES INC INTERNATIONAL ISOTOPES, INC. POLYFIL CORP BACHEM SA IDT AUSTRALIA LTD III 8/17/2000 A I I II II II II 8/18/2000 8/21/2000 8/17/2000 8/22/2000 II 9/11/2000 BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG TARO PHARMACEUTICAL INDUSTRIES LTD KRKA DD NOVO MESTO IRVINE SCIENTIFIC SALES COMPANY TECHNOLOGY COMMERCIALIZATION INTERNATIONAL, INC. AMPACET CORP I A I A III III III II II 8/3/2000 8/11/2000 8/3/2000 8/10/2000 8/15/2000 A I A A A A II II IV II II II II 5/26/2000 8/10/2000 8/8/2000 8/4/2000 8/14/2000 7/25/2000 8/15/2000 HOVIONE FARMACIENCIA SA GLAXO WELLCOM INC. FMC BIOPOLYMER AS POLYPEPTIDE LABORATORIES INC RANBAXY LABORATORIES LTD MACCO ORGANIQUES SRO SHANGHAI SINE PHARMACEUTICAL CORP., LTD. BASF AKTIENGESELLSCHAFT INEOS ABS USA CORP BASF AKTIENGESELLSCHAFT OTSUKA PHARMACEUTICAL CO LTD CUNO INC I I I A I A I A II II II II III II II IV IV 7/25/2000 8/2/2000 8/3/2000 8/29/2000 7/31/2000 7/25/2000 8/8/2000 8/24/2000 8/10/2000 STATUS Type SUBMIT DATE A III II 7/24/2000 8/4/2000 HOLDER POLYONE CORP SUBJECT CC00012984D4/WE AS MANUFACTURED IN VONORE, TN.

4Q2012

CHINOIN PHARMACEUTICAL AND CHEMICAL PGE1 ETHYL ESTER AS MFG IN BUDAPEST, HUNGARY WORKS LTD TEVA GROUP SULFAMETHOXAZOLE USP AS MANUFACTURED IN NETANYA, ISRAEL ALCHYMARS SPA PROLIGO LLC CAMBREX PROFARMACO MILANO SRL BETTS UK LTD SUN PHARMACEUTICAL INDUSTRIES LTD NIPPON SODA CO LTD QUALICAPS CO LTD FMC CORP ALENDRONATE SODIUM AS MFG IN MILANO ITALY GTI-2040 DRUG SUBSTANCE AS MFG IN BOULDER, COLORADO PROPAFENONE HYDROCHLORIDE AS MFG IN PAULLO (MILANO), ITALY BETTS UK LTD LAMINATE TUBES AS MFG IN ESSEX, UNITED KINGDOM PENTOXIFYLLINE E.P/B.P AS MFG IN MAHARASHTRA, INDIA FAROPENEM DALOXATE AS MFG IN TOYAMA, JAPAN EDIBLE INKS AS MFG IN NARA, JAPAN LUSTRECLEAR N MICROCRYSTALLINE CELLULOSE/CARRAGEENAN-BASED COATING AS MFG IN NEWARK, DELAWARE MOMETASONE 17-FUROATE AS MFG IN LOURES, PORTUGAL CEFUROXIME AXETIL BULK DRUG SUBSTANCE SODIUM ALGINATE AS MFG IN OSLO, NORWAY OCTREOTIDE ACETATE DRUG SUBSTANCE AS MFG IN TORRANCE, CA. LISINOPRIL USP (NON-STERILE BULK) AS MFG IN PUNJAB, INDIA CALCIUM CHLORIDE DIHYDRATE USP AS MFG IN BRUNTAL, CZECH REPUBLIC BIFICO AS MFG IN SHANGHAI, P.R. CHINA TERLURAN GP-22NATURAL AS MFG IN TAMPS, MEXICO LUSTRAN ABS 308-1000 FOR PACKAGING AS MFG IN ADDYSTON, OHIO TERLURAN GP-35 NATURAL AS MFG IN TAMPS, MEXICO REBAMIPIDE(OPC-12759) DRUG SUBSTANCE AS MFG IN SAGA, JAPAN ZETA PLUS M SERIES GRADED DENSITY MEDIA AND CARTIDGE PRODUCTS AS MFG IN STAFFORD SPRINGS, CT. EPINASTINE AS MFG IN INGELHEIM AM RHEIN, GERMANY BETAMETHASONE 17-VALERATE, USP MICRONIZED AS MFG IN HAIFA BAY, ISRAEL ENALAPRILA USP AS MFG IN NOVO MESTO, SLOVENIA IS-CHO AS MFG IN SANTA ANA, CA ACCELERATOR-PRODUCED PALLADIUM-103 (103 PD) MEDICAL RADIOISOTOPE AS MFG IN TROITSK, RUSSIA 100664 MOLD RELEASE POLYETHYLENE MASTERBATCH AS MFG IN TERRE HAUTE,IN; DERIDDER,LA; CARTERSVILLE,GA ; HEATH,OH; LATEXO,TX; MESSANCY,BELGIUM. EX-CELL PF CHO MEDIUM (MODIFIED) CATALOG NO. 67480 AS MFG IN DENVER, PA SODIUM IODIDE I-123 RADIOCHEMICAL AS MFG IN DENTON, TEXAS POLYFIL CONCENTRATES ABC5000 AND MT5000 AS MFG IN ROCKAWAY, NJ PERGOLIDE MESYLATE AS MFG IN VIONNAZ, SWITZERLAND MINOCYCLINE HYDROCHLORIDE USP AS MFG IN VICTORIA, AUSTRALIA

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4Q2012EXCEL DMF# 15015 I 15016 15017 15018 15019 A 15020 I 15021 A 15022 A 15023 15024 15025 15026 15027 15028 15029 I 15030 15031 15032 I 15033 I 15034 15035 15036 A 15037 15038 I 15039 15040 I 15041 15042 15043 15044 15045 15046 I A I A I A II III II II II II 9/15/2000 9/12/2000 9/28/2000 9/13/2000 8/11/2000 9/18/2000 FARCHEMIA SRL NEMO SA ACS DOBFAR SPA DAIICHI FINE CHEMICAL CO LTD MYLAN LABORATORIES LTD ELI LILLY AND COMPANY DISULFIRAM AS MANUFACTURED IN TREVIGLIO(BERGAMO), ITALY PACKAGING MATERIALS AS MANUFACTURED IN BARCELONA, SPAIN DEFU(DECARBAMOYLCEFUROXINE) AS MFG IN VIMERCRATE (MILANO), ITALY MISOPROSTOL DRUG SUBSTANCE AS MANUFACTURED IN TOYAMA, JAPAN FLUCONAZOLE USP AS MFG IN ANDHRA PRADESH, INDIA A II III 9/15/2000 9/8/2000 GLAXOSMITHKLINE LLC BASELL POLIOLEFINE ITALIA SRL A II II 9/8/2000 9/14/2000 IPCA LABORATORIES LTD BOEHRINGER INGELHEIM CHEMICALS INC A A III III IV 8/24/2000 8/24/2000 9/14/2000 POLYONE CORP POLYONE CORP CARGILL INC III 8/21/2000 BASF AKTIENGESELLSCHAFT I A II II III 9/13/2000 9/4/2000 8/21/2000 LEDERLE LABORATORIES TATEYAMA KASEI CO LTD BASF AKTIENGESELLSCHAFT I A A I A I II II II II IV II II 8/22/2000 8/25/2000 8/31/2000 9/7/2000 9/7/2000 9/13/2000 9/13/2000 II 9/12/2000 ORCHID CHEMICALS AND PHARMACEUTICALS LTD COBRA THERAPEUTICS LIMITED HETERO DRUGS LTD ZACH SYSTEM SPA LEK PHARMACEUTICALS DD FREUND CORP LEDERLE LABORATORIES LEDERLE LABORATORIES II 9/12/2000 XELLIA PHARMACEUTICALS APS III 8/25/2000 STELLA KUNSTSTOFFTECHNIK GMBH I A I II II II III 8/25/2000 8/17/2000 8/28/2000 9/11/2000 BECTON DICKINSON CO EVERLIGHT CHEMICAL INDUSTRIAL CORP CADILA HEALTHCARE LTD SOLVIN SA STATUS Type SUBMIT DATE III 8/24/2000 HOLDER AMPACET CORP SUBJECT

4Q2012

190695 FDA BLACK POLYETHYLENE MASTERBATCH AS MFG IN TERRE HAUTE, IN; CARTERSVILLE, GA; DERIDDER, LA; LATEXO, TX; HEATH, OHIO; MESSANCY, BELGIUM PROTEOSE PEPTONE N0.3 AS MFG IN DETROIT, MICHIGAN; SPARKS, MARYLAND MISOPROSTOL AS MFG IN TAOYUAN HSIEN, TAIWAN LORATIDINE AS MFG IN GUJARA, INDIA SOLVIN 271GA AS MFG IN JEMEPPE-SUR-SAMBRE (BELGIUM); RHEINBERG (GERMANY); SANTO ANDRE-SP (BRAZIL); TAVAUX (FRANCE); MARTORELL (SPAIN). PROTECAP, CHILD-RESISTANCE CLOSURE; STELLA-ARTICLE 6-4418-02-01 AS MFG IN ELTVILLE, GERMANY TOBRAMYCIN SULPHATE, NON-STERILE BULK (ESUB) AS MANUFACTURED IN COPENHAGEN S, DENMARK CEFAZOLIN, USP AS MFG IN KANCHEEPURAM DISTRICT, INDIA PLASMID DNA PRODUCTION PROCESS AS MFG IN STAFFORDSHIRE, UNITED KINGDOM OMEPRAZOLE AS MFG IN ANDHRA PRADESH, INDIA TSE 424 ACETATE AS MFG IN ALMISANO DI LONIGO (VICENZA), ITALY LISINOPRIL ACTIVE DRUG SUBSTANCE AS MFG IN KOLODVORSKA, SLOVENIA NONPARIEL-105T AS MFG IN HAMAMATSU CITY, JAPAN NYSTATIN BULK POWDER AS MFG IN PEARL RIVER, NY DECLOMYCIN(DEMECLOCYCLINE HYDROCHLORIDE) BULK POWDER AS MFG IN PEARL RIVER, NY ACHROMYCIN (TETRACYCLINE) BULK, AS MFG IN PEARL RIVER, NY QUAZEPAM AS MFG IN TOYAMA PREFECTURE, JAPAN LURAN S 757 R NATURAL AND WHITE 00260 AS MFG IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY LURAN S 777 K NATURAL AND WHITE 00260 AS MFG IN LUDWIGSCHAFEN, FEDERAL REPUBLIC OF GERMANY CC00022594WE AS MANUFACTURED IN VONORE, TN. CC00017674DF/DR/WE AS MANUFACTURED IN VONORE, TN. CONTRAMID 92450 AS MANUFACTURED IN SAS VAN GENT, THE NETHERLANDS AND HAUBOURDIN CEDEX, FRANCE ATENOLOL AS MFG IN SEJAVTA DISTRICT, RATLAM, INDIA LEVO-ALPHA-ACETYL-METHADOL (LAAM) HYDROCHLORIDE AS MANUFACTURED IN PETERSBURG, VIRGINIA PAROXETINE HYDROCHLORIDE AS MANUFACTURED IN COUNTY CORK, IRELAND LUPOLEN 2003 H AS MANUFACTURED IN WESSELING, FEDERAL REPUBLIC OF GERMANY

RECOMBINANT PORCINE CARBOXYPEPTIDASE B (RCPB) AS MFG IN FERGERSHEIM, FRANCE

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4Q2012EXCEL DMF# 15047 15048 I 15049 A 15050 A 15051 15052 A 15053 A 15054 15055 15056 15057 15058 15059 A 15060 A 15061 15062 A 15063 15064 15065 15066 I 15067 A 15068 15069 15070 15071 15072 15073 15074 15075 15076 A 15077 15078 A A II III 10/2/2000 9/14/2000 BAYER PHARMA AG PRESSPART GMBH CO KG TESTOSTERONE USP AS MFG IN IXTACZOQUITLAN, VER. MEXICO I A A A A A A A II III III III III III II III III 9/28/2000 9/27/2000 9/29/2000 9/28/2000 9/28/2000 9/28/2000 10/2/2000 9/29/2000 9/11/2000 DAIICHI FINE CHEMICAL CO LTD POLYONE CORP POLYONE CORP POLYONE CORP POLYONE CORP POLYONE CORP UNIQUE CHEMICALS POLYONE CORP NAMICOS CORP III 6/24/2000 AMCOR FLEXIBLES SINGEN GMBH A A A II II II III 9/29/2000 9/29/2000 9/29/2000 9/27/2000 SICOR DE MEXICO SA DE CV IFOTAM CO LTD LUNDBECK PHARMACEUTICALS ITALY SPA AMPACET CORP MOMETASONE FUROATE USP AS MANUFACTURED IN LERMA, EDO MEXICO IFOSFAMIDE AS MANUFACTURED IN LODZ, POLAND DAPSONE AS MFG IN PADOVA, ITALY A III II 9/25/2000 9/29/2000 POLYONE CORP NISSHIN PHARMA INC II 9/21/2000 I A I A I II IV II II II II 9/18/2000 9/20/2000 9/25/2000 8/15/2000 9/22/2000 9/22/2000 DSM MINERA BV BASF SE AKZONOBEL SURFACE CHEMISTRY LLC SAFC BIOSCIENCES INC UBE INDUSTRIES LTD JOHNSON MATTHEY PHARMACEUTICAL MATERIALS EVONIK TECHNOCHEMIE GMBH V 9/12/2000 SOUTHWEST ONCOLOGY GROUP I II II 9/18/2000 9/18/2000 SANKYO CO LTD CIPLA LTD III 9/15/2000 HOSPIRA INC III 9/15/2000 HOSPIRA INC STATUS Type SUBMIT DATE I II III 9/18/2000 9/15/2000 HOLDER ELI LILLY AND COMPANY ASTRA PLASTIQUE SUBJECT

4Q2012

RECOMBINANT BOVINE TRYPSIN (RTRYPSIN) AS MFG IN FEGERSHEIM, FRANCE. VISTOP 28 THERMO-PLASTIC CLOSURES AS MFG IN SAINT-GEORGES DE RENEINS, FRANCE FC97 POLYOLEFIN FLEXIBLE CONTAINER AS MFG IN NORTH CHICAGO, ILLINOIS AND AUSTIN, TEXAS STERILIZATION OF PORT ASSEMBLIES FOR THE FLEXIBLE CONTAINER AS MFG IN ROCKY MOUNT, NC AND EL PASO, TEXAS CS-505 DRUG PRODUCT AS MFG IN TOKYO, JAPAN OLANZAPINE (ESUB) AS MANUFACTURED IN KURKUMBH, BANGALORE, PATALGANGA, VIKHROLI, INDIA CLINICAL INVESTIGATION METHODS TO ASSURE PATIENT SAFETY AND SCIENTIFIC INTEGRITY AS PERFORMED AT SAN ANTONIO, TEXAS KETONE BISULFITE ADDUCT(KBA) AS MFG IN MAARSSEN, THE NETHERLANDS KOLLICOAT SR 30 D AS MFG IN LUDWIGSHAFEN, GERMANY DERMACRYL 79 (28-079P) AS MFG IN SALISBURY, NC STEMMAX(TM), PRODUCT NO. 62647 AS MFG IN DENVER, PA CS-747 DRUG SUBSTANCE AS MFG IN YAMAGUCHI, JAPAN D-THREO-METHYLPHENIDATE HYDROCHLORIDE AS MFG IN WEST DEPTFORD, NJ THIAPROLINE-M-AMINOBENZOIC ACID MONOHYDROCHLORIDE AS MFG IN HANAU, GERMANY CC00012694A2/D4/60 AS MANUFACTURED IN VONORE, TN. EPA-E DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN CHIYODA-KU, TOKYO, JAPAN

11078-DR WHITE POLYETHYLENE MASTERBATCH AS MFG IN TERRE HAUTE, IN;CARTERSVILLE,GA;HEATH,OH;LATEXO,TX OR MESSANCY,BELGIUM. PACKAGING MATERIALS AS MFG IN SHELBYVILLE, KY; KREUZLINGEN, SWITZERLAND; AND SINGEN, GERMANY MISOPROSTOL HPMC DISPERSION AS MFG IN OMIYA SAITAMA, JAPAN CC00014978WE AS MANUFACTURED IN VONORE, TN. CC00012674D4/DR AS MANUFACTURED IN VONORE, TN. CC00012975DR AS MANUFACTURED IN VONORE, TN. CC00016462DR AS MANUFACTURED IN VONORE, TN. CC00014448WE AS MANUFACTURED IN VONORE, TN. DICLOFENAC POTASSIUM AS MFG IN GUJARAT, INDIA CC00002127WE AS MANUFACTURED IN VONORE, TN. GLASS AMPOULES USED FOR PHARMACEUTICAL PACKAGING AS MFG IN SHINGA, JAPAN

ALUMINUM ALLOY METERED DOSE INHALER CONTAINERS INTERNALLY COATED WITH FLUOROPOLYMER AS MFG IN MARSBERG, GERMANY

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4Q2012EXCEL DMF# 15079 15080 15081 A 15082 15083 15084 I 15085 15086 15087 15088 15089 A 15090 A 15091 I 15092 15093 15094 15095 I 15096 A 15097 I 15098 15099 15100 15101 15102 A 15103 I 15104 I 15105 I 15106 A 15107 I III 10/17/2000 II 10/18/2000 ORCHID CHEMICALS AND PHARMACEUTICALS LTD FLINT HILLS RESOURCES LP II 10/13/2000 PROCOS SPA PRODOTTI CHIMICI III 10/16/2000 AMPACET CORP III 10/16/2000 AMPACET CORP A I A A II II II III II 10/18/2000 10/18/2000 10/19/2000 10/12/2000 10/18/2000 LUPIN LTD ASTRA IDL LTD ANGELINI ACRAF SPA POLYONE CORP NV ORGANON III 9/29/2000 BASF AKTIENGESELLSCHAFT II 10/16/2000 A I A II II II II 10/11/2000 10/12/2000 10/13/2000 10/9/2000 II 10/5/2000 II 10/13/2000 I A A A II III II II II 10/11/2000 10/12/2000 10/11/2000 10/13/2000 10/13/2000 NV ORGANON DAIWA SPECIAL GLASS CO LTD FARCHEMIA SRL JOHNSON MATTHEY INC JOHNSON MATTHEY PHARMACEUTICAL MATERIALS JOHNSON MATTHEY PHARMACEUTICAL MATERIALS CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS LTD HOSPIRA BOULDER INC FUJISAWA PHARMACEUTICAL CO LTD AIR LIQUIDE HEALTHCARE AMERICA CORP BEIJING FRIENDSHIP HOSPITAL LIVER RESEARCH CENTER LONZA BRAINE SA A A II II III 10/6/2000 10/10/2000 10/9/2000 NORAC CO INC MOEHS IBERICA SL AMPACET CORP STATUS Type SUBMIT DATE A N II 10/5/2000 II 10/6/2000 HOLDER HOSPIRA BOULDER INC NOT AN ASSIGNED NUMBER PROCOS SPA SUBJECT PACLITAXEL EXTRACT AS MFG IN BOULDER, COLORADO

4Q2012

THIAPROLINE-M-AMINO BENZOIC ACID HYRDOCHLORIDE CHEMICAL INTERMEDIATE FOR MK826 AS MFG IN CAMERI(NOVARA), ITALY DRONABINOL AS MANUFACTURED IN AZUSA, CALIFORNIA BISOPROLOL FUMARATE AS MFG IN RUBI SPAIN 10919 PROCESS AID POLYETHYLENE MASTERBATCH AS MFG IN TERRE HAUTE,IN;DERIDDER, LA;CARTERSVILLE,GA;HEATH,OH;LATEXO,TX, OR MESSANCY, BELGIUM ESTRADIOL BENZOATE AS MFG IN OSS, THE NETHERLANDS GLASS VIALS AS MFG IN YODOGAWA-KU, OSAKA, JAPAN METAXALONE AS MFG AS MFG IN TREVIGLIO(BERGAMO), ITALY AMPHETAMINE ASPARTATE AS MFG IN WEST DEPTFORD, NJ AMPHETAMINE SULFATE AS MFG IN WEST DEPTFORD, NJ. DEXTROAMPHETAMINE SACCHARATE AS MFG IN WEST DEPTFORD, NJ SPIROMETHYL-BIPHENYL-NITRILE (SR47563) AS MFG IN BUDAPEST, HUNGARY PACLITAXEL DRUG SUBSTANCE AS MFG IN BOULDER, COLORADO FK117 AS MFG IN YODOGAWA-KU, OSAKA, JAPAN SULFUR HEXAFLUORIDE (SF6) GAS AS MFG IN PLUMSTEADVILLE, PA WATER AND/OR ALCOHOL EXTRACTS OF HERBAL COMPOUND 861 AS MFG IN BEIJING, PEOPLES REPUBLIC OF CHINA PRAMLINTIDE (ACETATE) ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN BELGIUM EMULDER DS 2360 AS MANUFACTURED IN SCHWARTZHEIDE (FEDERAL REPUBLIC OF GERMANY) LISINOPRIL USP [BULK] AS MANUFACTURED IN MADHYA PRADESH, INDIA ACYCLOVIR USP, BULK, AS MANUFACTURED IN BANGALORE, INDIA METAXALONE AS MANUFACTURED IN APRILIA (LT), ITALY CC00008063WE AS MANUFACTURED IN VONORE, TN. NALTREXONE HYDROCHLORIDE AS MANUFACTURED IN APLEDOORN, THE NETHERLANDS 7746272 (RM46272) GREEN POLYPROPYLENE MASTERBATCH AS MFG IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA; HEATH, OH; LATEXO, TX; AND MESSANCY, BELGIUM 816030 WHITE POLYETHYLENE MASTERBACH AS MANUFACTURED IN KITCHENER ONTARIO, CANADA 1-(4- FLUOROBENZYL)-2-CHLOROBENZIMIDAZOLE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN CAMERI (NOVARA), ITALY CEPHALEXIN, USP, AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA HUNTSMAN POLYETHYLENES (LLDPE) L2101, L2102 AND H2110 AS MANUFACTURED IN ODESSA, TEXAS Page 444

4Q2012EXCEL DMF# 15108 I 15109 15110 15111 I 15112 15113 15114 A 15115 I 15116 I 15117 I 15118 15119 15120 A 15121 15122 I 15123 15124 15125 15126 A 15127 15128 15129 I 15130 15131 15132 15133 15134 A 15135 15136 15137 15138 15139 I A I I I III III III III II 11/7/2000 11/6/2000 11/2/2000 11/2/2000 11/7/2000 CATALENT PHARMA SOLUTIONS LLC POLYONE CORP CHROMA CORPORATION CHROMA CORPORATION CUNO EUROPE SA A A I I II II III III II 11/6/2000 11/8/2000 10/30/2000 12/11/2000 10/18/2000 NEULAND LABORATORIES LTD UQUIFA MEXICO SA DE CV ENICHEM SPA ENICHEM AMERICA INC PENTAGON FINE CHEMICAL LTD I A II II III 11/2/2000 10/31/2000 11/1/2000 ESTEVE QUIMICA SA MICROBIOPHARM JAPAN CO LTD AMLODIPINE BESILATE AS MANUFACTURED IN BARCELONA, SPAIN CALCITRIOL AS MANUFACTURED IN SHIZUOKA, JAPAN I A A III V II II 10/31/2000 10/24/2000 10/31/2000 11/2/2000 COGNIS GMBH ACTAVIS ITALY SPA FAKO ILACLARI A S BUYUKDERE TASMANIAN ALKALOIDS PROPRIETARY LTD I II II 10/31/2000 10/30/2000 EGIS PHARMACEUTICALS PUBLIC LTD CO RHODES TECHNOLOGIES I I II II II 10/30/2000 11/1/2000 11/1/2000 NEOMPS INC PHARMACIA AND UPJOHN CORK LTD SAFC BIOSCIENCES INC II 10/31/2000 CATALENT PHARMA SOLUTIONS LLC II 12/11/2000 MEDIS II 2/5/2001 MEDIS I A II II IV 10/23/2000 10/30/2000 10/6/2000 WOCKHARDT AMERICAS INC SANDOZ GMBH COLORCON INC I I II II III 10/23/2000 10/25/2000 10/24/2000 STATUS Type SUBMIT DATE II 10/24/2000 HOLDER WENZHOU NO.3 PHARMACEUTICAL FACTORY SANDOZ GMBH AMPACET CORP SUBJECT RIBAVARIN, USP, AS MANUFACTURED IN ZHEJIANG, CHINA CYCLOSPORIN D AS MANUFACTUERD IN KUNDL TYROL, AUSTRIA

4Q2012

YUNG ZIP CHEMICAL INDUSTRY CO LTD AIC MICONAZOLE AS MANUFACTURED IN TACHIA, TAIWAN 11070-DR WHITE POLYETHYLENE MASTERBATCH AS MFG IN TERRE HAUTE,IN; DERIDDER,LA; CARTERSVILLE,GA; HEATH,OH; OR LATEXO,TX LORAIDINE AS MANUFACTURED IN DIST.BHARUCH GUJARAT STATE, INDIA ASCOMYCIN AS MANUFACTURED IN KUNDL TYROL, AUSTRIA SUPPLEMENTARY INFORMATION FOR COLORCON PRODUCTS AS MANUFACTURED IN WEST POINT, PA, ENGLAND, INDIA, PUERTO RICO, PEOPLES REPUBLIC OF CHINA AND JAPAN MEDICAINE 2%-MEPIVICAINE 2%, EPINEPHIDRINE 1/100000, 1.8 AMPOULES AS MFG IN NABEUL, ITALY MEDICAINE 3%- MEPIVICAINE 3%, WITHOUT A VASOCONSTRICTOR, 1.8 AMPOULES AS MFG IN NABEUL, ITALY YXSORALEN-ULTRA SOFT GELATIN CAPSULES MANUFACTURE AS MANUFACTURED IN ST. PETERSBURG, FLORIDA SYNTHETIC PEPTIDE SYSTEMS MPS-116 AS MANUFACTURED IN SAN DIEGO, CA CYKLOKAPRON TABLETS AS MANUFACTURED IN MARINO DEL TORONTO, ITALY EX-CELL (R) 420 W/L-GLUTAMINE, CATALOG NO. 14420 AS MANUFACTURED IN DENVER, PENNSYLVANIA TAMOXIFEN CITRATE BULK AS MANUFACTURED IN BUDAPEST, KORMEND, HUNGARY MILLING OF ACTIVE PHARMACEUTICAL INGREDIENTS, EXCIPIENTS & FINE CHEMICALS MANUFACTURED IN COVENTRY, RI MYRITOL 318 AS MFG IN DUSSELDORF, GERMANY STERILE PRODUCTS MANUFACTURING FACILITIES IN NERVIANO, ITALY RANITIDINE HYDROCHLORIDE FORM I BULK AS MFG IN ISTANBUL, TURKEY BUPRENORPHINE BASE AS MANUFACTURED IN WESTBURY, TASMANIA, AUSTRALIA

CIBA SPECIALTY CHEMICALS CORPORATION CROMOPHTAL YELLOW GT-AD AS MFG IN MONTHEY, SWITZERLAND IPRATROPIUM BROMIDE AS MFG IN MADAK(DISTRICT) ANDHRA PRADESH, INDIA ZOLPIDEM TARTRATE AS MFG IN MORELOS, MEXICO SINKRAL L 320 WHITE 17664 AS MFG IN RAVENNA, ITALY. SINKRAL L 320 NA 18001 AS MFG IN RAVENNA, ITALY 3-OXAZOLIDINEATIC ACID,4-METHYL-2,5-DIOXO-A-(2-PHENYLETHYL) ETHYL ESTER AS MFG IN CHESHIRE, UNITED KINGDOM PACKAGING MATERIAL AS MFG IN WOODSTOCK, ILLINOIS CC0001269D4 AS MANUFACTURED IN VONORE, TN. LC22710 25/1 WHITE COLOR CONCENTRATE MANUFACTURED IN MCHENRY, ILLINOIS LC22711 25/1 WHITE COLOR CONCENTRATE MANUFACTURED AT MCHENRY, ILLINOIS ZETA PLUS CA,LA,SA,ZA, SERIES AS MFG IN FRANCE

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4Q2012EXCEL DMF# 15140 I 15141 15142 15143 15144 A 15145 A 15146 I 15147 A 15148 15149 15150 15151 15152 A 15153 15154 15155 15156 15157 I 15158 A 15159 A 15160 15161 A 15162 15163 I 15164 I 15165 15166 15167 A 15168 15169 15170 A A A II II II 11/30/2000 11/29/2000 11/29/2000 A I II II II 11/27/2000 11/14/2000 11/28/2000 II 11/27/2000 I II II 11/27/2000 11/28/2000 THERAPLEX CORPORATION I III II 1/10/2001 11/27/2000 II 11/27/2000 NATIONAL INSTITUTES HEALTH NATIONAL INSTITUTE DRUG ABUSE TEK PACKAGING GROUP CIPLA LTD II 11/22/2000 ZHEJIANG RUIBANG LABORATORIES INC I A I A III II II II II 11/20/2000 11/15/2000 11/21/2000 11/21/2000 11/24/2000 MAC CLOSURES INC MERCK KGAA RANKE QUIMICA SL RANBAXY LABORATORIES LTD DOTTIKON EXCLUSIVE SYNTHESIS AG TAMPER-EVIDENT CLOSURES AS MFG IN WATERLOO, QUEBEC, CANADA EMD 68 843 AS MFG IN DARMSTADT, GERMANY LAS 34475 AS MFG IN SANT ANDREU DE LA BARCA, BARCELONA, SPAIN LORAZEPAM USP AS MFG IN PUNJAB, INDIA A A I A II II II II III 11/16/2000 11/20/2000 11/20/2000 11/21/2000 11/20/2000 II 11/17/2000 HERAEUS PRECIOUS METALS GMBH AND CO KG FIDIA FARMACEUTICI SPA BAYER AG DESERET LABORATORIES INC PHILLIPS PLASTICS CORP MAC CLOSURES INC II 11/22/2000 CHR HANSEN INC II 11/17/2000 CIPLA LTD A A I II III II II 11/13/2000 11/15/2000 11/20/2000 11/20/2000 STATUS Type SUBMIT DATE II 11/10/2000 HOLDER ELAN PHARMACEUTICAL RESEARCH CORPORATION NEULAND LABORATORIES LTD REXAM HEALTHCARE PACKAGING INC VIBRANTIS SA DE CV ACS DOBFAR SPA SUBJECT

4Q2012

N1179(BMS-347070-01)NANO CRYSTAL SPRAY GRANULATED INTERMEDIATE AS MFG IN HORSHAM, PA RANITIDINE HYDROCHLORIDE USP AS MFG IN ANDHRA PRADESH, INDIA SVP PLASTIC BOTTLES AS MFG IN BATTLEBORO, NORTH CAROLINA METFORMIN HYDROCHLORIDE AS MFG IN EL SALTO, JALISCO, C.P., MEXICO CEFAZOLIN FOR INJECTION 100G & 300G PHARMACY BULK PACKS AS MFG IN MILANO, ITALY CETIRIZINE DIHYDROCHLORIDE (ESUB) AS MANUFACTURED IN RAIGAD(MAHARASHTRA) INDIA CAL-CARB 4457 (91:9 CALCIUM CARBONATE/STARCH GRANULATION) AS MFG IN STOUGHTON, WI CARBOPLATIN USP AS MFG IN HANAU, GERMANY METFORMIN HYDROCHLORIDE AS MFG IN MULAZZANO(LO)ITALY ASPIRIN USP AS MFG IN LA FELGUERA(ASTURIAS)SPAIN 90:10 CALCIUM CARBONATE/STARCH GRANULATION AS MFG IN ST.GEORGE, UTAH 5-CNAC DI-SODIUM SALT AS MFG IN MORTON GROVE, IL. CHILD-RESISTANT PUSH & TURN CLOSURES AS MFG IN WATERLOO, QUEBEC, CANADA

2-CHLORO-3-(4 FLUOROBENZYL)-BENZIMIDE HYDROCHLORIDE(FBI HCL) AS MFG IN SWITZERLAND THIOSTREPTON USP (NON-STERILE BULK FORM) AS MFG IN ZHEJIANG PROVINCE, PEOPLES REPUBLIC OF CHINA (S)-(+)-METHAMPHETAMINE HYDROCHLORIDE AS MFG IN TRIANGLE PARK, NORTH CAROLINA PACKAGING MATERIALS AS MFG IN HUNTLEY, IL. FLUCONAZOLE (ESUB) AS MANUFACTURED IN KURKUMBH VILLAGE TALUKA-DAUND DISTRICT-PUNE(MAHARASHTRA), INDIA PACLITAXEL SUBSTANCE AS MFG IN SHANGHAI, CHINA

SOUTHWEST SYNTHETIC PHARMACEUTICAL BUSPIRONE HYDROCHLORIDE AS MFG IN CHONGQING CITY, PEOPLES REPUBLIC OF GENERAL FACTORY CHINA LIPOTEC S A LEUPROLIDE ACETATE NON-STERILE BULK DRUG SUBSTANCE AS MFG IN HOSPITALET DE LLOBREGA, SPAIN BACHEM AG SINCALIDE AS MFG IN BUBENDORF, SWITZERLAND F2 CHEMICAL LTD PERFLUOROBUTANE AS MFG IN PRESTON, LANCASHIRE, ENGLAND JINAN JINDA PHARMACEUTICAL CHEMISTRY DANTROLENE SODIUM NON-STERILE BULK DRUG SUBSTANCE AS MFG IN SHANDONG, CO LTD CHINA APOTEX PHARMACHEM INC PIRFENIDONE AS MFG IN TOLUCA, MEXICO RANBAXY LABORATORIES LTD RANBAXY LABORATORIES LTD ISOTRETINOIN USP (NON-STERILE BULK) AS MFG IN PUNJAB, INDIA MIDAZOLAM (NON-STERILE BULK) AS MFG IN PUNJAB, INDIA.

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4Q2012EXCEL DMF# 15171 A 15172 A 15173 15174 15175 15176 I 15177 A 15178 A 15179 15180 15181 15182 15183 15184 15185 A 15186 I 15187 15188 15189 15190 15191 15192 15193 A 15194 15195 15196 15197 15198 15199 15200 15201 15202 15203 15204 A A I A I I I A I I A II II II III III II II III III IV IV 12/18/2000 12/4/2000 12/13/2000 12/11/2000 12/14/2000 12/13/2000 11/12/2000 12/18/2000 12/20/2000 12/18/2000 12/19/2000 RANBAXY LABORATORIES LTD BASF PHARMA EVIONNAZ SA CUNO INC MATRIX PACKAGING INC PERLOS OYJ CEP PLASTICS KONTIOLAHTI PROLIGO LLC SOUTHERN HERBALS LIMITED STERI PLAS PTY LTD IWATA GLASS INDUSTRIAL CO.,LTD. CERESTAR USA INC KEWPIE CORP A A I I A A II III II IV II II II 12/7/2000 12/6/2000 12/11/2000 1/12/2001 12/15/2000 12/18/2000 12/19/2000 CHEMAGIS LTD QENOS PTY LTD TEVA PHARMACEUTICAL INDUSTRIES LTD PENWEST PHARMACEUTICALS CO ZENTIVA KS RANBAXY LABORATORIES LTD API CORP III 12/5/2000 CORMACK PACKAGING PARTY LTD. I A A I I I IV II II II III II III 11/14/2000 12/6/2000 12/4/2000 12/7/2000 12/5/2000 12/7/2000 12/7/2000 II 12/1/2000 III 12/1/2000 I A I II II III II 11/30/2000 12/4/2000 1/15/2001 11/28/2000 II 12/6/2000 STATUS Type SUBMIT DATE II 12/1/2000 HOLDER SUBJECT

4Q2012

UNION QUIMICO FARMACEUTICA SA UQUIFA MINOCYCLINE HYDROCHLORIDE USP AS MANUFACTURED IN MILAN, ITALY SA ESTEVE QUIMICA SA MOEXIPRIL HYDROCHLORIDE AS MANUFACTURED IN BARCELONA, CELRA' (GIRONA), SPAIN JENAHEXAL PHARMA GMBH 0.9% SODIUM CHLORIDE INJECTION,USP-1ML/2ML AMPOULE AS MFG IN GERMANY. FERMION OY ROHM AND HAAS CO ALDRICH CHEMICAL CO INC GLIPIZIDE AS MFG IN HANKO,FINLAND. ADCOTE 15P6M AS MFG IN AMERSFOOT, THE NETHERLANDS.

ROSE BENGAL, DISODIUM SALT, SIGMA-ALDRICH CHEMICAL CO. PRODUCT NUMBER W184-3 AS MANUFACTURED IN SHEBOYGAN FALLS, WI REXAM CONSUMER PLASTICS INC QVAR (BERCLOMETHASONE DIPROPIONATE HFA) INHALATION AEROSOL ACTUATORS AND DUST CAP AS MANUFACTURED IN BUFFALO, IL ZHEJIANG HISUN PHARMACEUTICAL CO LTD CYCLOPHOSPHAMIDE USP, NON-STERILE BULK DRUG AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA BHARTI HEALTHCARE LIMITED EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN HARYANA, INDIA GALENA AS EXCELLA GMBH NEOMPS INC LPS INDUSTRIES INC BOEHRINGER INGELHEIM CHEMICALS INC CORMACK PACKAGING PTY LTD PERGOLIDE MESYLATE AS MANUFACTURED IN CZECH REPUBLIC DICLOFENAC SODIUM AS MFG IN FEUCHT, GERMANY MPS-69 (SYNTHETIC PEPTIDE) AS MFG IN SAN DIEGO, CALIFORNIA VF60(METALIZED POLYESTER/LLDPE LAMINATION) AS MFG IN MOONACHIE,NJ. DEXRAZOXANE AS MFG IN PETERSBURG,VA. CORMACK/KERR CR-III 2 PIECE CHILD RESISTANT CLOSURE (CRC) AS MFG IN NEW SOUTH WALES, AUSTRALIA CORMACK/KERR CR-I 2 PIECE CHILD RESISTANT CLOSURE (CRC) AS MFG IN NEW SOUTH WALES, AUSTRALIA MOMETASONE FUROATE AS MFG IN BE'ER SHEVA,ISRAEL GF7660 WHITE 22 HDPE AS MFG IN ALTONA,VIC.,AUSTRALIA LEUPROLIDE ACETATE AS MFG IN BE'ER SHEVA AND NETANYA, ISRAEL TIMERX-A CONTROLLED RELEASE SYSTEM AS MFG IN DANBURY, CT. TETRAHYDROZOLINE HYDROCHLORIDE USP,AS MFG IN PRAHA,CZECH REPUBLIC. CEFPODOXIME PROXETIL AS MFG IN PUNJAB,INDIA MYCOPHENOLIC ACID, TECHNICAL GRADE (INTERMEDIATE) AS MFG IN SHIZUOKA-PREF., JAPAN CEFPODOXIME ACID AS MFG IN PUNJAB, INDIA CARBAMAZEPINE (CARBATOL) AS MFG IN ST-VULBAS, EIONNAZ, SWITZERLAND ZETA PLUS VIRAL REMOVAL MEDIA AS MFG IN STAFFORD SPRINGS, CT. PLASTIC CONTAINERS AS MFG IN MISSISSAUGA, ONTARIO, CANADA. TURBUHALER M3 AS MFG IN LEHMO, FINLAND. OLIGONUCLEOTIDE GTI-2501 AS MFG IN BOULDER, COLORADO. PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN ANEKAL TALUK, BANGALORE 70ML TABLET BOTTLE AS MFG IN MOOREBANK, NEW SOUTH WALES, AUSTRALIA. AMPULES AND VIALS AS MFG IN OSAKA, JAPAN. ERYTHRITOL AS MANUFACTURED IN HAMMOND, INDIANA PHOSPHATIDYCHOLINE DRUG EXCIPIENT AS MFG IN TOKYO, JAPAN.

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4Q2012EXCEL DMF# 15205 A 15206 15207 15208 15209 A 15210 15211 15212 A 15213 15214 I 15215 15216 15217 15218 15219 15220 15221 15222 15223 15224 15225 I 15226 I 15227 I 15228 A 15229 15230 I 15231 15232 15233 15234 A 15235 15236 I 15237 A II 12/28/2000 LUITPOLD PHARMACEUTICALS INC METHYLENE BLUE INJECTION, USP 1%, AS MFG IN SHIRLEY, NY. A II II 12/21/2000 12/28/2000 LUITPOLD PHARMACEUTICALS INC LUITPOLD PHARMACEUTICALS INC N I I II II II 12/21/2000 10/5/2000 1/4/2001 NOT AN ASSIGNED NUMBER PARTICLE DYNAMICS INC SAN FU CHEMICAL CO LTD ACS DOBFAR SPA DESTAB CALCIUM SULFATE 90 A/A AS MFG IN ST.LOUIS PARK, MINNESOTA BENZOIC ACID AS MFG IN TAINAN, TAIWAN I II III 1/8/2001 1/2/2001 II 1/4/2001 II 1/3/2001 II 1/4/2001 WUXI SHANHE GROUP NO.1 PHARMACEUTICAL CO.LTD. MEMORIAL SLOAN-KETTERING CANCER CENTER ORCHID CHEMICALS AND PHARMACEUTICALS LTD DSM DERETIL ALUPAK D.O.O. I A A A I I I I A I IV III II II II II II II II III III 12/22/2000 12/27/2000 1/2/2001 12/27/2000 12/22/2000 12/30/2000 1/3/2001 1/3/2001 1/4/2001 7/19/2000 12/13/2000 FONA INTERNATIONAL INC POLYONE CORP HARMAN FINOCHEM LTD CAMBREX KARLSKOGA AB CAMBREX CHARLES CITY INC BACHEM CALIFORNIA DIOSYNTH BV TEVA PHARMACEUTICAL INDUSTRIES LTD STERLING SRL PCI SERVICES INC COLOR MASTER INC A II IV 12/20/2000 5/8/2000 FARCHEMIA SRL FONA INTERNATIONAL INC A A II II IV 12/21/2000 12/26/2000 12/27/2000 JSC OLAINFARM LEK PHARMACEUTICALS DD SUHEUNG CAPSULE CO LTD A A A IV III II III 12/20/2000 12/18/2000 12/19/2000 12/21/2000 INTERNATIONAL SPECIALTY PRODUCTS STERI PLAS PTY LTD SANOFI AVENTIS DEUTSCHLAND GMBH GERRESHEIMER BUNDE GMBH STATUS Type SUBMIT DATE III 11/30/2000 HOLDER EASTMAN CHEMICAL CO SUBJECT

4Q2012

EASTAPAK, VORIDIAN, AND EASTAR POLYMER PRODUCTION AT CAROLINA EASTMAN DIVISION DIAZOLIDINYL UREA,(GERMALL II) AS MFG IN CHATHAM, NEW JERSEY 115 ML TABLET BOTTLE AS MFG IN MOOREBANK, NEW SOUTH WALES, AUSTRALIA RAMIPRIL AS MFG IN FRANKFURT, GERMANY CONTAINERS MADE FROM TUBULAR GLASS AS AMPOULES; CARTRIDGES AND VIALS UP TO 50ML AS MANUFACTURED IN BOLESLAWIEC, POLAND RIMANTADINE HYDROCHLORIDE AS MFG IN OLAINE, LATVIA CLAVULANATE POTASSIUM AS MFG IN TRIMLINI, SLOVENIA GELATIN AND HYDROXYPROPYL METHYCELLULOSE HARD SHELL CAPSULES AS MFG IN KYUNGGI-DO, KOREA. BETHANECHOL CHLORIDE AS MFG IN TREVIGLIO(BERGAMO), ITALY #884.167 N-C NATURAL ORANGE FLAVOR (WONF) (TG-4NA) AS MFG IN CAROL STREAM, ILLINOIS #937.129 BITTERING FLAVOR, NATURAL AS MFG IN CAROL STREAM, ILLINOIS CC00016405DR/WE AS MANUFACTURED IN VONORE, TN. METFORMIN HYDROCHLORIDE AS MFG IN MAHARASHTRA, INDIA HYDROUS BENZOYL PEROXIDE (BPO) USP (BULK) AS MFG INKARLSKOGA,SWEDEN CETIRIZINE DIHYDROCHLORIDE AS MFG IN CHARLES CITY, IOWA THYMOSIN ALPHAS-1 (BULK) AS MFG IN TORRANCE, CA NALTREXONE AS MFG IN APELDOORN, THE NETHERLANDS TORSEMIDE AS MFG IN BE'ER SHEVA, ISRAEL MEDROXYPROGESTERONE ACETATE AS MFG IN SOLOMEO DI CORCIANO, PERUGIA PACKAGING MATERIAL AS MFG IN WESTHOUGHTON, BOLTON, UNITED KINGDOM BL2017E, 638C FDA BLUE COLOR CONCENTRATE FOR PLASTICS AS MFG IN AVILLA, IN. ACETAMINOPHEN (PARACETAMOL) AS MFG IN WUXI CITY, JIANGSU PROVINCE, CHINA. SODIUM IODIDE-124 AS MFG IN NEW YORK,NY 7-AMINO-DESACETOXY-CEPHALOSPORANIC ACID AS MFG IN KANCHEEPURAN DISTRICT, INDIA. D(-)PHENYLGLYCINE AMIDE AS MFG IN GELEEN, THE NETHERLANDS. HEAT-WELDING ALUMINUM FOIL, THICKNESS 0.020MM FOR HEA-SEALING ON PVC AND PVDC (BLISTERFOIL) AS MFG IN SLOVENIA, EUROPE.

CEFUROXIME FOR INJECTION (75G AND 225G BULK PACKS) AS MFG IN TRIBIANO(MI), ITALY STERILE WATER FOR INJECTION,USP,AS MFG IN SHIRLEY,NY NEUTRA-CAINE (SODIUM BICARBONATE INJECTION) USP 7.5%, AS MFG IN SHIRLEY, NY.

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4Q2012EXCEL DMF# 15238 15239 15240 I 15241 15242 15243 15244 15245 I 15246 15247 A 15248 I 15249 15250 I 15251 15252 15253 15254 15255 15256 15257 A 15258 15259 A 15260 15261 15262 15263 I 15264 15265 I 15266 I 15267 15268 I 15269 15270 I I II II 1/25/2001 2/13/2001 A II IV 1/26/2001 1/24/2001 DIVIS LABORATORIES LTD TRICON VEREDLUNGS GMBH III 2/22/2001 COLORS FOR PLASTICS I III III 2/22/2001 2/22/2001 COLORS FOR PLASTICS COLORS FOR PLASTICS I A A III II II III 1/22/2001 1/24/2001 2/5/2001 1/17/2001 WL GORE AND ASSOC INC TEVA PHARMACEUTICAL INDUSTRIES LTD NV ORGANON RICON COLORS A II II 1/23/2001 1/22/2001 A A A A N I II II 1/12/2001 1/19/2001 II II II II 1/17/2001 1/16/2001 2/16/2001 2/16/2001 A II III 1/15/2001 1/18/2001 FERMION OY EXXON MOBIL CHEMICAL COMPANY,FILMS BUSINESS RANBAXY LABORATORIES LTD SCINOPHARM TAIWAN LTD FRESENIUS KABI AUSTRIA GMBH FRESENIUS KABI AUSTRIA GMBH NOT AN ASSIGNED NUMBER INTEROR GLAXO GROUP LIMITED D/B/A GLAXOSMITHKLINE ISOCHEM SA SANOFI CHIMIE ETHYL 4-AMINO-1-PIPERDINE CARBOXYLATE AS MFG IN CLAIS, FRANCE FONDAPARINUX SODIUM AS MFG IN OSS THE NETHERLANDS. EPAL-NCA AS MFG IN VERT-LE-PETIT, FRANCE III 1/17/2001 HUHTAMAKI VAN LEER RONSBERG I II IV 1/17/2001 1/12/2001 I I A A III III II II II 1/15/2001 1/15/2001 6/8/1999 1/15/2001 1/23/2001 NEW ENGLAND EXTRUSION INC. NEW ENGLAND EXTRUSION INC. ACS DOBFAR SPA POLYCARBON INDUSTRIES INC APOTHECON INC DIV BRISTOL MYERS SQUIBB SREENIVASA PHARMA PRIVATE LIMITED HENRY H OTTENS MFG CO INC STATUS Type SUBMIT DATE A A II III II 1/12/2001 12/19/2000 1/16/2001 HOLDER KYOWA HAKKO KIRIN CO LTD AMPACET CORP WOCKHARDT LTD SUBJECT KRN7000 AS MFG IN TAKASAKI-SHI GUNMA, JAPAN

4Q2012

11989-DI WHITE POLYETHYLENE MASTERBACH AS MFG IN MESSANCY, BELGIUM DOXAZOSIN MESYLATE AS MFG IN ANKLESHWAR, DIST. BHARUCH, GUJARAT STATE, INDIA NEX GRADE 4086 SHEETING AS MFG IN TURNERS FALLS, MA AND MILTON, WI NEX GRADE C8101 SHEETING AS MFG IN TURNERS FALLS, MA AND MILTON, WI OXACILLIN SODIUM MONOHYDRATE FOR INJECTION AS MFG IN MILANO, ITALY FLECAINIDE ACETATE USP AS MFG IN LEOMINSTER, MA. OXACILLIN SODIUM FOR ORAL SOLUTION AS MFG IN PRINCETON, NJ. FAMOTIDINE DRUG SUBSTANCE AS MFG IN ANDHRA PRADESH, INDIA. SPRAY DRIED NATURAL FLAVOR POTENTIATOR S-100-D AS MANUFACTURED IN PHILADELPHIA, PA FLEXIBLE LAMINATE FOR RETORTABLE LID FILM FOR CONTACT LENSES FOR AQUEOUS SALTY SOLVENT AS MFG IN RONSBERG, GERMANY. 6-MERCAPTOPURINE AS MFG IN ESPOO, FINLAND MO 01716-01 POLYPROPYLENE FILMS AS MFG IN MACEDON, NEW YORK. LORATADINE (NON-STERILE BULK) AS MFG IN NAWANSHAHAR, PUNJAB, INDIA RILUZOLE AS MFG IN SHAN-HUA, TAINAN COUNTY, TAIWAN, R.O.C. LACTULOSE SOLUTION AS MFG IN VICCHIO, ITALY LACTULOSE CRYSTALS SCM AS MFG IN VICCHIO, ITALY.

FONDAPARINUX SODIUM AS MFG IN SISTERON (CEDEX) AND NOTRE DAME DE BONDEVILLE, FRANCE LYOGUARD TRAY AS MANUFACTURED IN ELKTON, MD AZITHROMYCIN AS MANUFACTURED IN BE'ER SHEVA AND PETACH TIQVA, ISRAEL RECOMBINANT HUMAN INSULIN AS MFG IN THE NETHERLANDS AND FRANCE PACKAGING MATERIAL, WHITE, CPE-W986-1 AS MANUFACTURED IN WEST CHICAGO, IL COLORS FOR PLASTICS PRODUCT I.D.:R27624 PEACH AS MFG IN ELK GROVE, IL. COLORS FOR PLASTICS PRODUCT ID:B19353 PURPLE AS MFG IN ELK GROVE VILLAGE, IL. COLORS FOR PLASTICS PRODUCT ID:R27199 RUST AS MFG IN ELK GROVE VILLAGE, IL. DILTIAZEM HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

PET FILM 15 AND 23 UM, ONE SIDE PRINTED WITH MAT LAQUER TO BE USED IN THE MANUFACTURE OF TTS SYSTEMS AS MANUFACTURED IN FREIBURG, GERMANY QINGDAO FTZ UNITED INTERNATIONAL, INC. CAPSAICIN NATURAL AS MANUFACTURED IN SHANGDONG, CHINA ONO PHARMACEUTICAL CO LTD SIVELESTAT SODIUM HYDRATE AS MFG IN FUKUI, JAPAN.

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4Q2012EXCEL DMF# 15271 I 15272 15273 15274 A 15275 15276 C 15277 15278 I 15279 I 15280 15281 15282 15283 I 15284 15285 15286 15287 15288 A 15289 15290 15291 15292 15293 A 15294 15295 I 15296 15297 15298 15299 15300 15301 15302 15303 15304 A A I A A N A I N III II 2/8/2001 2/16/2001 III III II II II 1/31/2001 1/18/2001 3/16/2001 2/23/2001 2/22/2001 3M DRUG DELIVERY SYSTEMS POLIMERI EUROPA FRANCE SA FARMABIOS S P A DR REDDYS LABORATORIES LTD SUMITOMO CHEMICAL CO LTD NOT AN ASSIGNED NUMBER POLYONE CORP KOWA CO LTD NOT AN ASSIGNED NUMBER CC00015957D4/DR AS MANUFACTURED IN VONORE, TN. NK-104 TABLETS AS MFG IN FUJI SHIZUOKA, JAPAN A IV III 1/12/2001 2/14/2001 A I I I II II II II II 2/15/2001 2/16/2001 2/19/2001 2/14/2001 2/15/2001 FIDIA FARMACEUTICI SPA DSM PHARMACEUTICALS INC SIFAVITOR SPA ORGAMOL SA CATALENT PHARMA SOLUTIONS LLC I A A A II II III II II 1/31/2001 2/8/2001 2/5/2001 2/12/2001 2/27/2001 SUMITOMO SEIKA CHEMICALS CO LTD BIDACHEM SPA HEINKE TECHNOLOGY INC TEVA PHARMACEUTICAL INDUSTRIES LTD ELI LILLY AND CO A I I III IV IV III 2/8/2001 2/8/2001 2/8/2001 2/9/2001 ROLLPRINT PACKAGING PRODUCTS INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC HARCOSTAR DRUMS LTD III 10/4/2000 PLASDENE GLASS-PAK PTY LTD I III III 10/4/2000 10/4/2000 PLASDENE GLASS-PAK PTY LTD PLASDENE GLASS-PAK PTY LTD I II II 2/2/2001 2/6/2001 CATALENT PHARMA SOLUTIONS LLC TEVA PHARMACEUTICAL INDUSTRIES LTD A I II III III 1/30/2001 1/30/2001 1/30/2001 ACS DOBFAR SPA ROHM AND HAAS LOPAREX BV STATUS Type SUBMIT DATE III 1/26/2001 HOLDER TICONA GMBH SUBJECT

4Q2012

VECTRAN LIQUID CRYSTAL POLYMERS AS MANUFACTURED IN SHELBY, NORTH CAROLINA & FLORENCE, KENTUCKY CEFOTAXIME ACID AS MANUFACTURED IN TRIBIANO (MILANO), ITALY MORPRIME 10B (51754) AS MANUFACTURED IN ELK GROVE VILLAGE, IL FL2000 19 MICRON PET WITH GRADE CODES 78FX AND 78GJ AS MFG IN THE NETHERLANDS ACCUTANE (10MG, 40MG) AS MFG IN ST.PETERSBURG, FLORIDA CLARITHROMYCIN AS MFG IN EMEK SARA, BE'ER SHEVA, AND PETACH TIQVA, ISRAEL. 33MM WHITE WADDED SCT CLOSURE AS MFG IN PRESTON, VICTORIA, AUSTRALIA 200ML AND 500ML HDPE WHITE TABLET CONTAINER AS MFG IN PRESTON AND MORABBIN, VICTORIA, AUSTRALIA. 38MM WHITE WADDED TAMPER EVIDENT CLOSURE AS MFG IN PRESTON AND MOORABBIN, VICTORIA, AUSTRALIA. RPP#26-1117 AS MFG IN ADDISON, ILLINOIS AND BLOOMFIELD, CT. #825.321 N-C ARTIFICIAL CHERRY FLAVOR AS MFG IN CAROL STREAM, ILLINOIS 825.662 ARTIFICIAL CHERRY FLAVOR AS MFG IN CAROL STREAM, ILLINOIS 0008E FOR 60L OPEN TOP PLASTIC PACKAGING (60L UNIVERSAL) AS MFG IN THE UNITED KINGDOM. KETOSULFONE AS MFG IN HYOGO PREFECTURE, JAPAN. CROTAMITON AS MFG IN ITALY PREFILLED VAGINAL APPLICATOR AS MFG IN LINCOLN, NEBRASKA MUPIROCIN AS MFG IN ZAGREB, CROATIA CAPREOMYCIN SULFATE, STERILE BULK (CAPASAT) (ESUB) AS MANUFACTURED IN LIVERPOOL, ENGLAND PHENTERMINE HYDROCHLORIDE AS MFG IN GARBAGNATE MILANESE(MI) ITALY CLINDAMYCIN PHOSPHATE AS MFG IN GREENVILLE, NORTH CAROLINA THALIDOMIDE AS MFG IN FRAZIONE MARIANO(LODI), ITALY. CDT-PHOSPHATE AS MFG IN ST-VULBAS AND EVIONNAZ, SWITZERLAND.

NIFEDIPINE (10MG AND 20MG) SOFTGEL CAPSULE AS MFG IN ST.PETERSBURG, FLORIDA. HENRY H OTTENS MANUFACTURING CO INC FLAVOR POTENTIATOR 2-100 AS MFG IN PHILADELPHIA, PA. AMPACET CORP 11748 WHITE POLYETHYLENE MASTERBATCH AS MFG IN TERRE HAUTE,IN;DERIDDER,LA;CARTERSVILLE,GA;HEATH,OH;OR LATEXO,TX. SCOTCHPAK 9739 (2-MIL POLYESTER LAMINATE) AS MFG IN COTTAGE GROVE, MN. RIBLENE FC20 AS MFG IN DUNKIRK, FRANCE. BUDESONIDE AS MFG IN GROPELLO CAIROLI(PAVIA), ITALY. OLANZAPINE (FORM 1) AS MFG IN ANDHRA PRADESH, INDIA. MIRTAZAPINE AS MFG IN GIFU PREFECTURE, JAPAN.

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4Q2012EXCEL DMF# 15305 15306 15307 15308 15309 I 15310 15311 A 15312 15313 15314 15315 15316 I 15317 15318 A 15319 A 15320 15321 A 15322 15323 15324 15325 15326 15327 15328 15329 15330 15331 I 15332 A 15333 A 15334 15335 I 15336 15337 A A III II 3/27/2001 3/19/2001 DIAMOND POLYMERS INC SPI PHARMA INC A III II 4/4/2001 3/15/2001 THE TECH GROUP CATALENT PHARMA SOLUTIONS LLC II 3/30/2001 II 3/14/2001 XINJIANG HESHOU EPHIDRINE PRODUCTS CO.LTD. EVONIK DEGUSSA GMBH I A I A A A I A A II II II II II II II III III III 2/28/2001 3/2/2001 2/28/2001 2/28/2001 2/28/2001 3/1/2001 3/14/2001 3/8/2001 3/2/2001 3/12/2001 A IV II 3/2/2001 2/28/2001 II 2/23/2001 YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD KERRY CANADA INC BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI SPA LONZA LTD TEVA PHARMACEUTICAL INDUSTRIES LTD ZACH SYSTEM SPA DELMAR CHEMICALS INC AMINO CHEMICALS LTD TEVA PHARMACEUTICAL INDUSTRIES LTD WATSON PHARMACEUTICALS INC 3M DRUG DELIVERY SYSTEMS PMP CONSULTING CO LTD BUNDER GLAS GMBH PACLITAXEL (ESUB) AS MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA. I II II 2/28/2001 2/28/2001 I I A A III III II IV III 2/28/2001 2/26/2001 2/28/2001 2/27/2001 2/26/2001 PHARM GLASS ASO SDN BHO EAGLE COLOR CORPORATION BIOIBERICA SA ARAKAWA CHEMICAL INDUSTRIES LTD MEDISIZE CORPORATION KONTIOLAHTI PLANT SAUREFABRIK SCHWEIZERHALL CATALENT PHARMA SOLUTIONS LLC A II III 2/21/2001 2/22/2001 STATUS Type SUBMIT DATE A A A A II II II II IV 2/26/2001 2/26/2001 2/26/2001 2/26/2001 2/20/2001 HOLDER CAMBREX CHARLES CITY INC CAMBREX CHARLES CITY INC CAMBREX CHARLES CITY INC CAMBREX CHARLES CITY INC TECHNICAL FLAVORS AND FRAGRANCES INC. INTERNATIONAL SPECIALTY PRODUCTS 3M DRUG DELIVERY SYSTEMS SUBJECT DEXTROAMPHETAMINE SACCHARATE AS MFG IN CHARLES CITY,IA. AMPHETAMINE ASPARTATE AS MFG IN CHARLES CITY, IA. DEXTROAMPHETAMINE SULFATE AS MFG IN CHARLES CITY, IA. AMPHETAMINE SULFATE AS MFG IN CHARLES CITY,IA.

4Q2012

NATURAL ANISE EXTRACT(789-647B) AND ARTIFICIAL STRAWBERRY FLAVOR(789-780) AS MFG IN AMITYVILLE,NY. ALLANTOIN AS MFG IN CHATHAM, NJ. COTRAN 9752, NON-WOVEN WHITE RAYON MEDICAL TAPE, WITH ADHESIVE COATING ON ONE SIDE AS MFG IN BROOKINGS,SD. GLASS AMPOULES AND VIALS AS MFG IN MALAYSIA. SHEETFED OFFSET PRINTING INK AS MFG IN PENNSAUKEN, NJ. SODIUM HYALURONATE AS MFG IN BARCELONA, SPAIN. ARKON P-100 (EXCIPIENT) AS MFG IN OKAYAMA, JAPAN. DISPOSABLE SYRINGE FOR JELLY AS MFG IN LEHMO, FINLAND. CDTP (DRUG INTERRMEDIATE) AS MFG IN PRATELN, SWITZERLAND. ROCALTROL (0.25MCG & 0.5MCG) SOFTGEL CAPSULE AS MFG IN ST. PETERSBURG, FL.

BLUE RASPBERRY NA/ARTIFICIAL FLAVOR MC 4778 AS MFG IN GRANBY, CANADA. PRAZOSIN HYDROCHLORIDE BULK SUBSTANCE AS MFG IN FRESONARA(AR), ITALY. KETOSULFONE AS MFG IN VISP, SWITZERLAND MIRTAZAPINE AS MFG IN BE'ER SHEVA, ISRAEL. KETOSULFONE AS MFG IN LONIGO, ITALY. PYRAZINAMIDE AS MFG IN QUEBEC, CANADA. FOSINOPRIL SODIUM AS MFG IN MARSA, MALTA. BETAMETHASONE ACETATE AS MFG IN MILAN, ITALY. CYCLOSPORINE AS MFG IN HANGZHOU, ZHEJIANG, PEOPLES REPUBLIC OF CHINA. COTRAN 9737 POLYOLEFIN FILM AS MFG IN BROOKINGS, SD. SILICON PROCESS VIALS AND AMPOULES AS MFG IN SHIGA, JAPAN. PLASTIC BOTTLES AND DROPPER BOTTLE SYSTEMS FOR OPHTHALMIC PRODUCTS AND OTHER APPLICATIONS UP TO CONTENTS OF 250ML CAPACITY AS MFG IN BUENDE, FEDERAL REPUBLIC OF GERMANY AND BOLESLAWIEC, POLAND. PSEUDOEPHEDRINE HYDROCHLORIDE AS MFG IN HESHOU COUNTY, XINJIANG, CHINA. N6-TRIFLUORACETYL-L-LYSYL-L-PROLINE MANUFACTURED IN HANAU AND RADEBEUL, GERMANY. PACKAGING MATERIALS AS MFG IN SCOTTSDALE, A LANOXICAPS (0.5, 0.10, AND 0.20MG) SOFTGEL CAPSULES AS MFG IN ST.PETERSBURG, FL. POLYMER BLENDS (ESUB) AS MANUFACTURED IN AKRON, OHIO MAGNESIUM HYDROXIDE PASTE/POWDER USP AS MFG IN LEWES, DE.

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4Q2012EXCEL DMF# 15338 15339 15340 A 15341 15342 15343 A 15344 15345 15346 I 15347 A 15348 A 15349 15350 15351 15352 15353 15354 15355 15356 I 15357 15358 15359 15360 I 15361 15362 15363 15364 15365 I 15366 15367 A 15368 15369 15370 15371 I A A N II III III 4/10/2001 4/5/2001 4/10/2001 GENTA INC NOLATO JAYCARE LTD INEOS CHLORVINYLS BELGIUM NV NOT AN ASSIGNED NUMBER A II II 4/10/2001 3/30/2001 A I A A II II IV II II 3/29/2001 4/4/2001 3/30/2001 4/2/2001 4/1/2001 A A A II III II II 4/12/2001 3/30/2001 3/29/2001 3/30/2001 I A I A A I I III III III II II IV III III 3/26/2001 3/26/2001 3/26/2001 3/28/2001 3/28/2001 3/22/2001 3/23/2001 3/26/2001 NAMPAK PERSONAL CARE CONSOLIDATED CONTAINER CO LLC ALUPAK DOO RELIABLE BIOPHARMACEUTICAL CORP SHASUN PHARMACEUTICALS LTD EXXONMOBIL CHEMICAL CO ROHM AND HAAS CO BECTON DICKINSON PHARMACEUTICAL SYSTEMS TEVA PHARMACEUTICAL INDUSTRIES LTD WINPAK TECHNOLOGIES INC PISGAH LABS INC ELAN PHARMACEUTICAL RESEARCH CORPORATION GEDEON RICHTER PLC RANBAXY LABORATORIES LTD ZEON CORP DIVIS LABORATORIES LTD PHARMACEUTICAL FINE CHEMICALS BAHAMAS UNIQUE CHEMICALS WUHAN WUYAO PHARMACEUTICAL CO LTD II 3/23/2001 3M PURIFICATION INC II 3/20/2001 WEX PHARMACEUTICALS INC I I III II III 3/27/2001 3/16/2001 3/21/2001 LUDLOW COATED PRODUCTS AKZO NOBEL POLYMER CHEMICALS LLC AMPACET CORP I A IV III V 2/5/2001 3/9/2001 12/14/2000 ALPINE AROMATICS INTERNATIONAL INC BERRY PLASTICS CORP WEST PHARMACEUTICAL SERVICES INC STATUS Type SUBMIT DATE A A II II II 2/21/2001 4/13/2001 2/21/2001 HOLDER CAMBREX CHARLES CITY INC TARO PHARMACEUTICAL INDUSTRIES LTD CAMBREX CHARLES CITY INC SUBJECT D-AMPHETAMINE BASE AS MFG IN WARREN, NJ AND CHARLES CITY, IA. ETODOLAC USP MICRONIZED AS MFG IN HAIFA BAY, ISRAEL.

4Q2012

DL-AMPHETAMINE BASE ACTIVE PHARMACEUTICAL INGREDIENT AS MFG IN WARREN, NJ AND CHARLES CITY, IA. SKIN CARE TYPE FRAGRANCE#223-520 AS MFG IN PISCATAWAY, NJ. PRODUCT 24-5-141 AS MANUFACTURED IN HOMER, LA CONTRACT TESTING FOR PACKAGING COMPONENTS FOR THE PHARMACEUTICAL INDUSTRY IN LIONVILLE, PA. 3 MIL POLYESTER FILM/4W-2 AS MFG IN MERIDIAN, MS. PERKADOX API (BENZOYL PEROXIDE) AS MFG IN BURT, NY. 49974 BLACK SLIP POLYPROPYLENE AS MFG IN TERRE HAUTE, IN; CARTERSVILLE, GA; DERIDDER, LA; LATEXO, TX; HEATH, OH; AND MESSANCY, BELGIUM. TETRODOTOXIN DRUG SUBSTANCE AS MFG IN NANNING CITY, GUANGXI, PEOPLES REPUBLIC OF CHINA BETAFINE PLEATED POLYPROLYLENE CARTRIDGE PRODUCTS (BETAFINE D SERIES, BETAFINE XL SERIES, AND BETAFINE PP & PG SERIES) 15ML PHARMAPAC BOTTLE AS MFG IN LEICESTER, UNITED KINGDOM. PACKAGING MATERIAL AS MFG IN HAMPSTEAD, NH. PRINTED HEAT WELDING ALUMINUM FOIL AS MFG IN SLOVENIA, EUROPE. FLOXURIDINE AS MFG IN ST. LOUIS, MO. METHOHEXITAL AS MFG IN CUDDALORE, INDIA. VISTANEX POLYISOBUTYLENE RUBBER AS MFG IN BAYTOWN, TX. GREEN BAY ADHESIVE 103 AS MFG IN WEST PHILADELPHIA, PA. BD MONOVIAL LUER AXS AS MFG IN ENGLAND AND FRANCE. DOXERCALCIFEROL AS MFG IN BE'ER SHEVA ISRAEL. PACKAGING MATERIALS AS MFG IN TORONTO, ONTARIO, CANADA IMIPRAMINE PAMOATE AS MFG IN PISGAH FORREST, NC. BICIFADINE TABLETS AS MFG IN ATHLONE COUNTY, WESTMEATH, IRELAND. AZELASTINE HCL AS MANUFACTURED IN BUDAPEST, HUNGARY FLUOXETINE HYDROCHLORIDE AS MFG IN PUNJAB, INDIA QUINTAC 3570C (AN EXCIPIENT) AS MFG IN TOKYO, JAPAN. NABUMETONE AS MFG IN ANDHRA PRADESH, INDIA. METAXALONE AS MFG IN FREEPORT, GRAND BAHAMA ISLAND, BAHAMAS DICLOFENAC ACID AS MFG IN GUJARAT, INDIA. NOREPINEPHRINE BITARTRATE USP, NON-STERILE, BULK DRUG AS MFG IN WUHAN, CHINA DJ-927 DRUG SUBSTANCE AS MFG IN TOKYO, JAPAN. ANTIBIOTIC BOTTLES WITH POURER NECK AS MFG IN NEW CASTLE UPON TYNE, UK. MARVYLAN S 5902 AS MANUFACTURED IN THE NETHERLANDS.

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4Q2012EXCEL DMF# 15372 15373 15374 15375 15376 15377 I 15378 15379 15380 15381 15382 I 15383 15384 A 15385 15386 15387 I 15388 15389 I 15390 I 15391 15392 15393 A 15394 15395 I 15396 15397 15398 15399 15400 15401 A 15402 15403 15404 15405 A I I I II II III III 4/25/2001 4/26/2001 3/31/2001 4/23/2001 POLYPEPTIDE LABORATORIES INC ERREGIERRE SPA BETTS UK LIMITED AKZO NOBEL INKS CORP I I I I A III II II III III IV 4/17/2001 4/19/2001 4/13/2001 4/18/2001 4/18/2001 4/26/2001 A III III 4/5/2001 4/5/2001 COPE ALLMAN JAYCARE LTD COPE ALLMAN PLASTIC PACKAGING LIMITED SOLUTIA INC CEDARBURG PHARMACEUTICALS LLC IPCA LABORATORIES LTD BASELL POLIOLEFINE ITALIA SPA WESTLAKE PETROCHEMICALS LP ACG ASSOCIATED CAPSULES PRIVATE LTD COPHARM BOTTLE AS MFG IN PORTSMOUTH, HAMPSHIRE, UNITED KINGDOM. I A II III III 4/3/2001 4/25/2001 4/17/2001 INDUSTRIES MONFEL S.A. DE C.V. WESTLAKE LONGVIEW CORP INEOS OLEFINS AND POLYMERS USA III 10/4/2000 PLASDENE GLASS PAK I II III 4/18/2001 4/30/2001 PROLIGO THIOATES LLC CLARIANT(CANADA) INC OLIGONUCLEOTIDE INX-3001 AS MFG IN BOULDER, COLORADO A A II IV III 4/18/2001 4/18/2001 4/12/2001 MALLINCKRODT INC HEBEI WENDA CHEMICALS CO LTD SOLUTIA INC A IV II 5/7/2001 5/8/2001 A I I I III III III II II 4/5/2001 4/9/2001 4/10/2001 4/11/2001 4/16/2001 HEINKE TECHNOLOGY INC LIQUITANE ROCHESTER CHROMA CORPORATION LONZA INC STATUS Type SUBMIT DATE I I I A A III III III III II II 4/10/2001 4/4/2001 4/5/2001 4/2/2001 4/5/2001 4/6/2001 HOLDER CREATIVE FORMING CATALENT GERMANY SCHORNDORF GMBH DUPONT POLYESTER POLYONE CORP QUIMICA SINTETICA SA UNITED LABORATORIES LTD SUBJECT POLYETHYLENE TEREPHTHALATE SHEET AS MFG IN RIPON, WI PACKAGING MATERIALS AS MFG IN SCHORNDORF, GERMANY KALIDAR X70 AS MFG IN FAYETTEVILLE, NC CC00004396WE AS MANUFACTURED IN VONORE, TN. SUMATRIPTAN SUCCINATE AS MFG IN MADRID, SPAIN

4Q2012

AMOXICILLIN USP BULK SUBSTANCE AS MFG IN GUANGDONG, PEOPLES REPUBLIC OF CHINA PREFILLED VAGINAL APPLICATOR AS MFG IN LINCOLN, NE PACKAGING MATERIAL AS MFG IN ROCHESTER, NY PC2118C 20/1 WHITE COLOR CONCENTRATE AS MFG IN MCHENRY, IL. CDT PHOSPHATE AS MANUFACTURED IN CONSHOCKEN, PA

TAIHUA NATURAL PLANT PHARMACEUTICAL PACLITAXEL AS MFG IN LUONAN COUNTY SHAANXI PROVINCE, CHINA. CO.,LTD. WACKER CHEMIE AG AMORPHOUS FUMED SILICON DIOXIDE (HDK N 20) AS MFG IN GERMANY JANSSEN PHARMACEUTICA NV GALANTAMINE HYDROBROMIDE DRUG SUBSTANCE(SYNTHETIC) AS MFG IN BELGIUM AND AUSTRALIA DEXTROAMPHETAMINE SULFATE (ESUB) AS MANUFACTURED IN ST.LOUIS, MO. EFFERVES (AMINO ACID COMPLEX) AS MFG IN HEBEI PROVINCE, CHINA. CPFILMS WATER BASED DEEP DYED FILMS AS MFG IN FEILDALE AND MARTINSVILLE, VA.

01SHI-227, STYRENE WHITE MASTERBATCH AS MFG IN ONTARIO AND QUEBEC, CANADA. 30ML AMBER GLASS TABLET BOTTLE AS MFG IN PRESTON VICTORIA, AUSTRALIA AND JAKARTA, INDONESIA ACETYLSALICYLIC ACID AS MFG IN MEXICO EMAC SPECIALTY COPOLYMERS AS MFG IN LONGVIEW, TX. ARCO POLYPROPYLENE HOMOPOLYMERS HM20A1 AS MFG IN LONG BEACH, CALIFORNIA

2 PIECE PUSH-LOK CRC CLOSURE AS MFG IN PORTSMOUTH, HAMPSHIRE, UNITED KINGDOM CLEARSIL RELEASE FILMS AS MFG IN MARTINSVILLE AND FIELDALE, VA. DOXERCALCIFEROL AS MFG IN MILWAUKEE, WI. TRICLOSAN AS MFG IN INDIA LUPOLEN 1810 D AS MFG IN WESSELING, GERMANY LINEAR LOW-DENSITY POLYETHYLENE RESINS AS MFG IN SULPHUR, LOUISIANA. HARD GELATIN CAPSULE SHELLS AS MANUFACTURED IN SATARA, MAHARASHTRA HUMAN SECRETIN ACETATE DRUG SUBSTANCE AS MFG IN TORRANCE, CALIFORNIA OXICONAZOLE NITRATE AS MFG IN BERGAMO, ITALY QVAR ACTUATOR AND DUSTCAP AS MFG IN THE UNITED KINGDOM. PACKAGING MATERIALS INKS AS MFG IN PLYMOUTH, MN

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4Q2012EXCEL DMF# 15406 15407 15408 I 15409 A 15410 15411 15412 15413 15414 15415 15416 A 15417 A 15418 15419 15420 15421 15422 15423 15424 15425 15426 A 15427 15428 A 15429 15430 I 15431 I 15432 15433 15434 15435 15436 15437 15438 15439 15440 I A A A A I A I A III II II II II III II III II 5/14/2001 5/15/2001 5/15/2001 5/15/2001 5/15/2001 5/2/2001 5/8/2001 5/14/2001 5/15/2001 POLIMERI EUROPA SRL NEULAND LABORATORIES LTD NEULAND LABORATORIES LTD MALLINCKRODT INC DR REDDYS LABORATORIES LTD TETTAUER GLASHUTTENWERKE AG FIDIA FARMACEUTICI SPA SUNALLOMER LTD EVONIK TECHNOCHEMIE GMBH ERACLENE BB76 AS MFG IN BRINDISI, ITALY OFLOXACIN AS MFG IN ANDHRA PRADESH, INDIA ENALAPRIL MALEATE AS MFG IN ANDHRA PRADESH, INDIA III 5/14/2001 CLARIANT (CANADA) INC I II III 5/15/2001 5/15/2001 ROCHE DIAGNOSTICS GMBH AMPACET CORP A II II 5/17/2001 5/15/2001 GEDEON RICHTER PLC MALLINCKRODT INC I A I C A A A A II II III II II II IV II IV 5/4/2001 5/3/2001 5/4/2001 1/25/2000 5/11/2001 4/30/2001 5/8/2001 5/9/2001 5/8/2001 FARMAK A S RANBAXY LABORATORIES LTD SEALED AIR CORPORATION YUKI GOSEI KOGYO CO LTD DSM FINE CHEMICALS NETHERLANDS BV FINETECH PHARMACEUTICAL LTD ROBERTET FLAVORS INC MALLINCKRODT INC ROBERTET FLAVORS INC II 5/7/2001 JANSSEN PHARMACEUTICA NV I I A A I I IV II II II II II III 4/30/2001 5/1/2001 5/3/2001 5/4/2001 5/4/2001 5/4/2001 5/4/2001 SEPPIC S.A. WOCKHARDT LTD SIGNA SA DE CV CILAG AG VIBRANTIS SA DE CV R.P. SCHERER NORTH AMERICA MULTISORB TECHNOLOGIES INC MONTANIDE ISA 703 AS MFG IN CASTRES, FRANCE CEFUROXIME AXETIL(CRYSTALLINE) USP AS MFG IN ANKLESHWAR, INDIA GEMFIBROZIL USP DRUG SUBSTANCE AS MFG IN TOLUCA,MEX.,MEXICO MEFLOQUINE HYDROCHLORIDE AS MFG IN SCAFFHAUSEN, SWITZERLAND SULFAMETHOXAZOLE AS MFG IN JALISCO, MEXICO II 4/30/2001 STATUS Type SUBMIT DATE A N II 4/24/2001 II 4/26/2001 HOLDER BASF ORGAMOL PHARMA SOLUTIONS SA NOT AN ASSIGNED NUMBER BAYER HEALTHCARE LLC ANIMAL HEALTH DIV APOTEX INC HYALURONIC ACID BULK DRUG AS MFG IN SHAWNEE MISSION, KANSAS ALENDRONATE SODIUM TRIHYDRATE USP AS MFG IN ONTARIO, CANADA SUBJECT IRBESARTAN(SR47436) AS MFG IN SWITZERLAND

4Q2012

HYDERGINE(ERGOLOID MESYLATES) 1MG SOFTGELS AS MFG IN ST. PETERSBURG, FL FRESH PAX TYPE A, B, D, AND R OXYGEN ABSORBING PRODUCTS AS MFG IN BUFFALO, NY. NEBIVOLOL HYDROCHLORIDE(R067555) DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN GEEL, BELGIUM DILTIAZEM HYDROCHLORIDE AS MFG IN CZECH REPUBLIC FEXOFENADINE HYDROCHLORIDE AS MFG IN PUNJAB, INDIA TRANSDERMAL FILM, TDF SERIES, AS MFG IN NORDERSTEDT, DEUTSCHLAND. PROTAMINE SULFATE AS MFG IN IWAKI-CITY, FUKUSHIMA, JAPAN. KETONE BISULFITE ADDUCT (KBA) AS MFG IN THE NETHERLANDS CABERGOLINE AS MFG IN NESHER, ISRAEL SPRAY DRIED ARTIFICIAL CHERRY FLAVOR NV-1489 AS MFG IN PISCATAWAY, NJ. AMPHETAMINE SULFATE (ESUB) AS MANUFACTURED IN ST.LOUIS, MISSOURI SPRAY DRIED ARTIFICIAL FLAVOR(CHERRY MIXED FRUIT TYPE) FOR ANTIBIOTIC NV-7757 AS MFG IN PISCATAWAY, NJ. OXANDROLONE AS MFG IN BUDAPEST, HUNGARY DEXTROAMPHETAMINE SACCHARATE (ESUB) AS MANUFACTURED IN ST.LOUIS, MISSOURI IBANDRONATE, EDITION I, AS MFG IN MANNHEIM, GERMANY 7011785 RESIN MELT BLEND AS MFG IN TERRE HAUTE,IA; DERIDDER,LA; CARTERSVILLE,GA; HEATH,OH; OR LATEXO,TX. REM 104-CAG WHITE POLYETHYLENE MASTERBACH AS MFG IN LAHNSTEIN, GERMANY

AMPHETAMINE ASPARTATE (ESUB) AS MANUFACTURED IN ST. LOUIS, MISSOURI ONDANSETRON HYDROCHLORIDE DIHYDRATE AS MFG IN ANDHRA PRADESH, INDIA GLASS PACKAGING MATERIAL AS MFG IN FRIEDRICHSDORF, GERMANY FENOFIBRATE AS MFG IN MULAZZANO(LO), ITALY POLYPROPYLENE PACKAGING MATERIALS AS MFG IN OITA PREFECTURE, JAPAN AZELASTINE HYDROCHLORIDE BULK DRUG AS MFG IN RADEBEUL, GERMANY

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4Q2012EXCEL DMF# 15441 I 15442 15443 I 15444 15445 15446 A 15447 I 15448 15449 15450 15451 15452 15453 15454 15455 15456 15457 15458 15459 15460 15461 15462 15463 15464 15465 A 15466 I 15467 15468 15469 15470 15471 15472 A 15473 15474 A 15475 I II 5/29/2001 LONZA LTD A III IV 5/30/2001 5/29/2001 POLYONE CORP ROBERTET FLAVORS INC A A A I A II II II II IV IV 5/31/2001 5/31/2001 6/4/2001 6/1/2001 6/5/2001 5/17/2001 II 6/5/2001 I A I I A A I I A A A N A A A I A IV II II II II II 5/31/2001 5/29/2001 5/31/2001 5/29/2001 5/25/2001 5/31/2001 III IV II II II III IV II II II II 5/24/2001 5/22/2001 5/2/2001 5/23/2001 5/11/2001 5/24/2001 5/23/2001 5/17/2001 5/24/2001 5/4/2001 5/3/2001 II 5/15/2001 I A II II III 5/18/2001 5/15/2001 5/16/2001 A II II 5/14/2001 5/18/2001 CHEMISCHE FABRIK BERG GMBH TECHNOLOGY COMMERCIALIZATION INTERNATIONAL INC AVECIA BIOTECHNOLOGY INC NEULAND LABORATORIES LTD FUJIMORI KOGYO CO LTD STATUS Type SUBMIT DATE IV 5/18/2001 HOLDER FONA INTERNATIONAL INC SUBJECT

4Q2012

#884.56 N-C ORANGE CREAM FLAVOR NATURAL AND ARTIFICIAL AS MFG IN CAROL STREAM, IL. PHENTERMINE HYDROCHLORIDE USP AS MFG IN BITTERFELD, GERMANY MOLYBDENUM-99 OF U235 (N,F) PRODUCED BY RUSSIAN ACADEMY OF SCIENCES BRANCH OF KARPOV INSTITUTE REACTOR, OBNINSK, KALUGA REGION, RUSSIA ORI-1001 DRUG SUBSTANCE AS MFG IN MILFORD, MA ITRACONAZOLE, PH. EUR.,AS MFG IN ANDHRA PRADESH, INDIA

RELEASE LINER FILM FOR USE IN TRANSDERMAL DRUG DELIVERY PATCHES AS MFG IN OGASA-GUN, SHIZOKA PREFECTURE, JAPAN. YUNG SHIN PHARMACEUTICAL INDUSTRIES PANCRELIPASE CR PELLETS AS MFG IN TAIWAN, REPUBLIC OF CHINA CO LTD SUPREME INDUSTRIES LIMITED POLYVINYL CHLORIDE FILMS AS MANUFACTURED IN BHIND DISTRICT, INDIA KEWPIE CORP BIOSEPRA SA WOCKHARDT LTD NAGAOKA AND CO LTD POLYONE CORP EXXONMOBIL CHEMICAL CO FINORGA A DIVISION OF SYLACHIM CHEMAGIS LTD FARMHISPANIA SA BASF ORGAMOL PHARMA SOLUTIONS SA NOT AN ASSIGNED NUMBER BASF SE CAMBREX CHARLES CITY INC RESOLUTION CHEMICALS LIMITED CHEMI SPA SYN TECH CHEM AND PHARM CO LTD NATIONAL INSTITUTES HEALTH NATIONAL INSTITUTE DRUG ABUSE ELI LILLY AND COMPANY CLINTON LABORATORIES JENAHEXAL PHARMA GMBH JENAHEXAL PHARMA GMBH COPRIMA S.A. CHEMICA ARAKAWA CHEMICAL INDUSTRIES LTD WILD FLAVORS INC KOLLIDON SR AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY PHENTERMINE HYDROCHLORIDE AS MFG IN CHARLES CITY, IA LATANOPROST AS MFG IN BERKSHIRE, UK AND ANDHRA PRADESH, INDIA PAROXETINE ACETATE AS MFG IN PATRICIA (FROSINONE), ITALY. PRAMOXINE HYDROCHLORIDE AS MFG IN TAIWAN, R.O.C. METHAMPHETAMINE HYDROCHLORIDE, INJECTABLE 10MG/1ML, 1ML AMPOULES, AS MFG IN LEXINGTON, KENTUCKY DIPEPTIDYLAMINOPEPTIDASE (DDAP) AS MANUFACTURED IN FEGERSHEIM, FRANCE. 0.9% SODIUM CHLORIDE INJECTION AS MFG IN WEIMAR AND JENA, GERMANY STERILE WATER FOR INJECTION AS MFG IN WEIMAR AND JENA, GERMANY FENOFIBRATE AS MFG IN BARCELONA, SPAIN. ISOMETHEPTENE MUCATE USP AS MANUFACTURED IN LOS ANGELES, CA EXCIPIENT KE-311 AS MANUFACTURED IN JAPAN NATURAL COLA TYPE FLAVOR WITH COLOR #FADS813 AS MANUFACTURED IN ERLANGER, KY PRODUCT NUMBER PK8-0070FG AS MANUFACTURED IN BURLINGTON, NJ SPRAY DRIED ARTIFICIAL FLAVOR (CHERRY RASPBERRY TYPE) FOR ANTIBIOTIC NV-7759 AS MANUFACTURED IN PISCATAWAY, NJ EPROSARTAN AS MANUFACTURED IN VISP, SWITZERLAND PURIFIED YOLK LECITHIN DRUG EXCIPIENT AS MFG IN TOKYO, JAPAN. MEP HYPERCEL AS MANUFACTURED IN ST. PIERRE LES ELBERT, FRANCE. CEFUROXIME AXETIL (AMORPHOUS) AS MANUFACTURED IN GUJARAT STATE, INDIA MENTHOL AS MFG IN HYOGO, JAPAN CC00088583WE AS MANUFACTURED IN VONORE, TN. VISTANEX LM POLYISOBUTYLENE PRODUCTS AS MFG IN LINDEN, NJ CRE16336 AS MFG IN CHASSE-SUR-RHONE, FRANCE FLUTICASONE PROPIONATE AS MFG IN BE'ER SHEVA, ISRAEL FH-108 AS MFG IN BARCELONA, SPAIN CLOPIDOGREL BISULFATE, FORM II, AS MFG IN SWITZERLAND, AND FRANCE.

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4Q2012EXCEL DMF# 15476 15477 15478 15479 I 15480 15481 15482 15483 A 15484 15485 15486 15487 15488 15489 15490 A 15491 15492 A 15493 15494 15495 15496 15497 A 15498 15499 15500 I 15501 I 15502 A 15503 15504 15505 15506 15507 15508 15509 15510 A A A A A I N I II 6/29/2001 II II II II II III 6/21/2001 7/11/2001 6/26/2001 6/28/2001 6/28/2001 7/6/2001 IV 6/20/2001 IV 6/21/2001 I I II III III 6/22/2001 4/24/2001 6/21/2001 CHEMI SPA BESPAK PLC SHINKO CHEMICAL CO., LTD A I A N II 6/27/2001 II II II 6/18/2001 6/21/2001 6/7/2001 INTERQUIM SA ADVANCED VIRAL RESEARCH GLAXOSMITHKLINE LLC NOT AN ASSIGNED NUMBER LONZA BIOTEC SRO CITICOLINE MONOSODIM SALT AS MANUFACTURED IN BARCELONA, SPAIN. I II III 6/15/2001 6/18/2001 RECORDATI CORP SOLVIN SA A A A N I A III IV IV 6/12/2001 6/15/2001 6/18/2001 II II II 6/14/2001 6/20/2001 6/21/2001 A A I IV IV IV IV 6/11/2001 6/14/2001 6/14/2001 6/12/2001 PHOSPHOLIPID GMBH FONA INTERNATIONAL INC FONA INTERNATIONAL INC MOLKEREI MEGGLE WASSERBURG GMBH AND CO KG SOCIETA ITALIANA MEDICINALI SCANDICCI BOEHRINGER INGELHEIM CHEMICALS INC FARMAK AS NOT AN ASSIGNED NUMBER POLIMERI EUROPA FRANCE SA WACKER CHEMIE AG EASTMAN CHEMICAL CO ERACLENE MP90 AS MANUFACTURED IN PORTO-TORRES, ITALY METHYL BETA-CYCLODEXTRIN AS MANUFACTURED IN EDDYVILLE, IOWA CELLULOSE ACETATE BUTYRATE (CAB-171-15) PHARMACEUTICAL GRADE AS MANUFACTURED IN KINGSPORT, TN NABUMETONE AS MANUFACTURED IN LATINA, ITALY STATUS Type SUBMIT DATE A A I II III II III 6/7/2001 6/6/2001 5/31/2001 6/6/2001 HOLDER EUTICALS LIMITED POLYONE CORP DAICEL CHEMICAL INDUSTRIES LTD AMPACET CORP SUBJECT FLUCYTOSINE USP AS MANUFACTURED IN THE UNITED KINGDOM CC00017673WE/DR AS MANUFACTURED IN VONORE, TN. CHIRACEL OF CSP AS MANUFACTURED IN JAPAN

4Q2012

100675 SLIP ANTIBLOCK COP MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA, HEATH, OH, OR LATEXO, TX PHOSPHOLIPON 100H GMBH AS MANUFACTURED IN GERMANY 825.382 W.S. ARTIFICIAL CHERRY FLAVOR AS MANUFACTURED IN CAROL STREAM, IL 856.085 ARTIFICIAL GRAPE FLAVOR AS MANUFACTURED IN CAROL STREAM, IL MEGGLE CELLACTOSE 80 AS MANUFACTURED IN WASSERBURG, GERMANY OXAPROZIN AS MANUFACTURED IN FIRENZE, ITALY METHYLPHENIDATE HYDROCHLORIDE AS MANUFACTURED IN PETERSBURG, VA ZOLPIDEM TARTRATE AS MANUFACTURED IN CZECH REPUBLIC.

SOLVIN 260RF AS MANUFACTURED IN BELGIUM, GERMANY, BRAZIL, FRANCE, AND SPAIN

PEPTIDE-NUCLEIC ACID SOLUTION, BULK AS MANUFACTURED IN FREEPORT, BAHAMAS TICARCILLIN MONOSODIUM (NON-STERILE) AS MANUFACTURED IN SINGAPORE THYMIDINE MANUFACTURED BY FERMENTATION AS MANUFACTURED IN CZECH REPUBLIC POPC POSITIONAL PURITY 95% AS MANUFACTURED IN FROSINONE, ITALY. NASAL ACTUATORS AND COVERS AS MANUFACTURED IN APEX, NC

BOTTLESK-70N AND CAP SK-2OON, AS MANUFACTURED IN FUJIEMINAMI KANAZAWA, ISHIKAWA, JAPAN HENRY H OTTENS MFG CO INC SPRAY DRIED NATURAL/ARTIFICAL COOL PEPPERMINT FLAVOR SD-1651 AS MANUFACTURED IN PHILADELPHIA, PA. HENRY H OTTENS MANUFACTURING CO INC POWDERED NATURAL ARTIFICIAL COOL PEPPERMINT FLAVOR #9650 AS MANUFACTURED IN PHILADELPHIA, PA. STAR LAKE BIOSCIENCE CO INC RIBAVIRIN, USP, AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA WATSON PHARMA PRIVATE LTD IRE INVENTAA CHEMICALS LTD BOEHRINGER INGELHEIM CHEMICALS INC TRUDELL MEDICAL INTERNATIONAL NOT AN ASSIGNED NUMBER SIFAVITOR SRL TRIMETHOPRIM AS MANUFACTURED IN FRAZIONE MAIRANO (LODI), ITALY NITROFURANTOIN MACROCRYSTAL USP, MANUFACTURED IN MAHARASHTRA, INDIA SODIUM IODIDE I131 (FISSION) AS MANUFACTURED IN ROMANS CEDEX (FRANCE) TRIMETHOPRIM AS MANUFACTURED IN KRISHNA DISTRICT, PIN, INDIA. GUAIFENESIN USP AS MANUFACTURED IN PETERSBURG, VA FOREST TOP MOUNTED DOSE INDICATOR AS MANUFACTURED IN ONTARIO, CANADA

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4Q2012EXCEL DMF# 15511 A 15512 A 15513 15514 15515 15516 15517 A 15518 A 15519 I 15520 15521 15522 I 15523 I 15524 A 15525 15526 I 15527 15528 15529 15530 15531 15532 15533 A 15534 15535 15536 I 15537 15538 A 15539 15540 15541 A I I III III III 7/6/2001 6/26/2001 5/31/2001 ALVEO AG BASF AKTIENGESELLSCHAFT FUJIMORI KOGYO CO LTD A II III 6/21/2001 7/6/2001 KYONGBO PHARMACEUTICAL CO LTD THE DOW CHEMICAL CO A I II III III 7/18/2001 7/13/2001 7/17/2001 FARMABIOS S P A BAYER AG AMPACET CORP A I A I A I III III II II III IV II 7/11/2001 6/5/2001 7/13/2001 7/17/2001 7/16/2001 7/16/2001 7/13/2001 DAIKIN INDUSTRIES, LTD SOLVIN S.A. SHASUN PHARMACEUTICALS LTD RP SCHERER NORTH AMERICA HISA KINZOKU KOGYO CO LTD THERMAX LTD., CHEMICAL DIVISION CATALENT PHARMA SOLUTIONS LLC A II II 7/4/2001 7/13/2001 FARMAK AS ELAN PHARMACEUTICAL TECHNOLOGIES II 7/13/2001 AVON ORGANICS LTD II 7/11/2001 OCEAN NUTRITION CANADA LIMITED A I II II IV 6/29/2001 6/22/2001 7/12/2001 II 8/31/2001 II 6/22/2001 I I A A II II II II II 7/3/2001 7/3/2001 6/28/2001 7/4/2001 6/28/2001 ERREGIERRE SPA PHARMACIA AND UPJOHN LONZA LTD EXCELLA GMBH CHIMEX III 7/7/2001 STATUS Type SUBMIT DATE II 7/3/2001 HOLDER SHANDONG XINHUA PHARMACEUTICAL CO LTD METAL COLOR CO LTD SUBJECT IBUPROFEN, USP AS MANUFACTURED IN THE PEOPLE'S REPUBLIC OF CHINA

4Q2012

BLISTER(PTP) PACKAGE OF PHARMACEUTICAL TABLETS/CAPSULES AS MANUFACTURED IN OSAKA, JAPAN GABAPENTIN AS MANUFACTURED IN BERGAMO, ITALY DOXORUBICIN HCL AS MANUFACTURED IN CO. COCK, IRELAND TP4 AS MANUFACTURED IN VISP, SWITZERLAND TIMOLOL MALEATE AS MANUFCTURED IN FEUCHT, GERMANY

MEXORYL SV (TEREPHTHALYLIDENE DICAMPHOR SULFONIC ACID AS MANUFACTURED IN MOURENX, FRANCE CALYX CHEMICALS AND PHARMACEUTICALS ZOPICLONE E.P. AS MANUFACTURED IN MAHARASHTRA, INDIA LTD MALLINCKRODT INC SODIUM PHOSPHATE MONOBASIC ANHYDRUS CODE 7869 AS MANUFACTURED IN ST. LOUIS, MO. CATALENT PHARMA SOLUTIONS LLC ADVIL COLD AND SINUS LIQUID GELS AS MANUFACTURED IN ST. PETERSBURG, FL FARMHISPANIA SA NIKKEN CHEMICALS CO LTD FH-111 AS MANUFACTURED IN BARCELONA, SPAIN ERYTHRITOL, A PHARMACEUTICAL EXCIPIENT AS MANUFACTURED IN CHITA CITY, JAPAN D-GLUCOSAMINE HYDROCHLORIDE AS MANUFACTURED IN MULGRAVE, NOVA SCOTIA, CANADA PSEUDOEPHEDRINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA TIZANIDINE HCL AS MANUFACTURED IN CZECH REPUBLIC MIV-150 ORAL NANOCRYSTAL COLLOIDAL DISPERSION AS MANUFACTURED IN HORSHAM, PA PCTFE MONO FILMS (NEOFLON CTFFE) AS MANUFACTURED IN OSAKA, JAPAN DIOFAN DS 2389 AS MANUFACTURED IN FEDERAL REPUBLIC OF GERMANY RANITIDINE HCL, USP AS MANUFACTURED IN CUDDALORE, INDIA AVC (SULFANILAMIDE) SUPPOSITORIES AS MANUFACTURED IN ST. PETERSBURG, FL PLASTIC CAPS AS MANUFACTURED IN OSAKA, JAPAN TULSION THERMACOAT L 100 AS MANUFACTURED IN MAHARASHTRA, INDIA DRISDOL SOFTGELS (ERGOCALCIFEROL, 50, 000 IU) AS MANUFACTURED IN ST. PETERSBURG, FL FLUMETHASONE AS MANUFACTURED IN PAVIA, ITALY MAKROFOL KG AS MANUFACTURED IN BAYERWERK, GERMANY 11070-T WHITE LLDPE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA, HEATH, OH OR LATEXO, TX CEFUROXIME ACID AS MANUFACTURED IN CHUNGCHEONG NAM-DO, KOREA POLYCAPROLACTONE RESINS AND CAPROLACTONE POLYOLS AS MANUFACTURED IN ROCK HILL, SC ALVEOLIT TEE POLYMER FOAMS EPOTAL P 800 AS MANUFACTURED IN FEDERAL REPUBLIC OF GERMANY RELEASE LINER FILM FOR USE IN TRANSDERMAL DRUG DELIVERY PATCHES E-0010 NO. 33AS MANUFACTURED IN SHIZUOKA PREF., JAPAN.

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4Q2012EXCEL DMF# 15542 15543 15544 A 15545 15546 15547 15548 15549 15550 15551 15552 15553 A 15554 A 15555 15556 15557 15558 15559 15560 I 15561 15562 15563 A 15564 15565 15566 15567 A 15568 15569 15570 15571 15572 15573 15574 15575 15576 I I I I I I I I I III III III III II II II III II 7/31/2001 7/31/2001 7/31/2001 7/31/2001 7/30/2001 8/6/2001 8/6/2001 8/7/2001 8/6/2001 CLARIANT INC CLARIANT INC CLARIANT INC CLARIANT INC SICOR SPA GLAXOSMITHKLINE ASTELLAS PHARMA INC MITSUBISHI CHEMICAL INDUSTRIES LTD BASF AKTIENGESELLSCHAFT YELLOW CLARIANT MASTERBATCHES 30PPP-300 BLUE CLARIANT MASTERBATCHES 40PPP-656 GREEN CLARIANT MASTERBATCHES 50PPP-564 PEACH CLARIANT MASTERBATCHES 90PPP-182 I I I II III II II 8/2/2001 7/17/2001 7/24/2001 7/31/2001 CATALENT PHARMA SOLUTIONS LLC ENICHEM SPA PROCOS SPA PRODOTTI CHIMICI EXCELLA GMBH CALDEROL SOFTGELS 20MCG AS MANUFACTURED IN ST.PETERSBURG, FL SINKRAL L 320/S WHITE 17673 AS MANUFACTURED IN RAVENNA, ITALY NIMESULIDE AS MANUFACTURED IN CAMERI (NOVARA), ITALY GANCICLOVIR (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY I A II II II 7/31/2001 7/31/2001 7/31/2001 DOCTOR REDDYS LABORATORIES LTD COSMA SPA COSMA SPA A I A A A II IV II III II II 7/30/2001 7/31/2001 8/1/2001 7/20/2001 8/1/2001 7/31/2001 V 7/26/2001 A I A I I A A A II II IV II III II II II II 7/25/2001 6/29/2001 7/15/2001 7/26/2001 7/24/2001 7/24/2001 7/11/2001 7/27/2001 7/31/2001 DIPHARMA FRANCIS SRL MEMORIAL SLOAN-KETTERING NITTA GELATIN INDIA LTD JOST CHEMICAL CO AMPACET CORP FRESENIUS KABI ANTI INFECTIVES SRL CAREFUSION CORPORATION CATALENT PHARMA SOLUTIONS LLC STATUS Type SUBMIT DATE A A II II III 7/25/2001 6/20/2001 7/20/2001 HOLDER ASH STEVENS INC WOCKHARDT LTD AR LA VE S SRL SUBJECT FLUDARABINE PHOSPHATE (ASP) AS MANUFACTURED IN RIVERDALE, MI. D-OXYPHENE BASE AS MANUFACTURED IN GUJARAT STATE, INDIA

4Q2012

PACKAGING MATERIALS AMPOULES TYPE I GLASS AS MANUFACTURED IN TREVIGLIO (BG), ITALY TRAMADOL HCL AS MANUFACTURED IN MILAN, ITALY [I124] FIAU AS MANUFACTURED IN NEW YORK, NY GELATIN AS MANUFACTURED IN KERALA, INDIA MAGNESIUM CITRATE AS MANUFACTURED IN ST. LOUIS, MO 110361 WHITE POLYETHYLENE MASTERBATCH CEFUROXIME SODIUM STERILE AS MANUFACTURED IN VILLADOSE (RO), ITALY VIANOX-H (NITRIC OXIDE) AS MANUFACTURED IN CHICAGO, ILLINOIS ADVIL PM LIQUI-GELS AS MANUFACTURE IN ST. PETERSBURG, FL

CALYX CHEMICALS AND PHARMACEUTICALS PYRAZINAMIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA LTD ADVANCED MICRODEVICES PVT LTD MEMBRANE DISC AND CARTRIDGE FILTERS USED FOR STERILIZATION OF DRUG PRODUCTS FARCHEMIA SRL TIZANIDINE HYDROCHLORIDE AS MANUFACTURED IN BERGAMO, ITALY DUPONT FLUOROPRODUCTS USV LIMITED DANAPAK FLEXIBLES AS PFIZER INC DR REDDYS LABORATORIES LTD DYMEL 227 EA/P(HEPTAFLUOROPROPANE) AS MANUFACTURED IN GREGORY, TEXAS BLENDED METFORMIN HCL AS MANUFACTURED IN MUMBAI, INDIA PHARMACEUTICAL COMPONENT AS MANUFACTURED IN DENMARK FLUMETHASONE AS MANUFACTURED IN KALAMAZOO, MI DEXTROMETHORPHAN HYDROBROMIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA DEXTROMETHORPHAN, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA TORSEMIDE 1016 (ESUB) AS MANUFACTURED IN BERGAMO, ITALY TORSEMIDE 1024 (ESUB) AS MANUFACTURED IN BERGAMO, ITALY

FLUOCINOLONE ACETONIDE 1,2-DIHYDRO AS MANUFACTURED IN MILAN, ITALY ASO1B ADJUVANT SYSTEM AS MANUFACTURED IN RIXENSART, BELGIUM FK778 DRUG SUBSTANCE AS MANUFACTURED IN OSAKA, JAPAN PHARMAKEEP OXYGEN ABSORBER RIBOFLAVIN 100 AS MANUFACTURED IN LUGWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY

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4Q2012EXCEL DMF# 15577 A 15578 15579 15580 15581 15582 I 15583 I 15584 I 15585 15586 15587 15588 15589 I 15590 I 15591 A 15592 15593 I 15594 15595 15596 15597 15598 15599 A 15600 15601 15602 15603 15604 15605 15606 15607 15608 15609 I I C I I A A A A A II II II II II II II II II II 8/27/2001 8/27/2001 8/14/2001 8/28/2001 8/29/2001 9/1/2001 9/1/2001 9/1/2001 9/1/2001 8/30/2001 CELSUS LABORATORIES INC MEDICHEM SA SOFRADIM PRODUCTION MALLINCKRODT INC TEVA PHARMACEUTICAL INDUSTRIES LTD ISP FREETOWN FINE CHEMICALS INC ISP FREETOWN FINE CHEMICALS INC ISP FREETOWN FINE CHEMICALS INC ISP FREETOWN FINE CHEMICALS INC JOHNSON MATTHEY INC DBA JOHNSON MATTHEY PHARMACEUTICAL MATER HEPARIN SODIUM ISOTONIC SOLUTION MANUFACTURED IN CINCINNATI,OH BRIMONIDINE TARTRATE AS MANUFACTURED IN GIRONA, SPAIN BOVINE ATELOCOLLAGEN CBF AS MANUFACTURED IN SAN DIEGO,CA I I A A I II III II II II II 8/15/2001 8/22/2001 8/27/2001 8/27/2001 8/27/2001 8/27/2001 IRVINE SCIENTIFIC SALES CO CODING PRODUCTS SEVEN STAR PHARMACEUTICAL CO LTD KYORIN PHARMACEUTICAL CO LTD CATALENT PHARMA SOLUTIONS LLC IHARA CHEMICAL INDUSTRY CO LTD A II III 8/24/2001 8/20/2001 SCINOPHARM TAIWAN LTD LOPAREX BV II 7/1/2001 POLYMER LABORATORIES LTD II 8/10/2001 C A A A II IV II III III 8/15/2001 8/13/2001 8/21/2001 8/13/2001 8/20/2001 FARMAK AS WACKER CHEMIE AG JUBILANT LIFE SCIENCES LTD SIGMUND LINDNER GMBH CCC PLASTIC CANADA COLORS AND CHEMICALS LTD. EURAND AMERICA INC II 8/15/2001 HOSPIRA INC II 8/10/2001 NATURAL PHARMACEUTICALS INC I A A A III III II III III 7/19/2001 8/7/2001 8/10/2001 8/13/2001 8/7/2001 STATUS Type SUBMIT DATE II 8/3/2001 HOLDER ERREDUE SPA INNOVATIVE CHEMICAL & LIFE LIQUID CONTAINER/PLAXICON KB SEIREN LTD EXCELLA GMBH TOPPAN PRINTING CO LTD LOPAREX BV SUBJECT

4Q2012

TIAMULIN HYDROGEN FUMARATE CLARIANT AS MANUFACTURED IN BERGAMO, ITALY 1-GALLON HDPE CONTAINER AS MANUFACTURED IN WEST CHICAGO, ILLINOIS MEDICAL BACKING CLOTH, H20 AS MANUFACTURED IN OSAKA, JAPAN TIMOLOL (S) BASE HEMIHYDRATE AS MANUFACTURED IN FEUCHT, GERMANY TOPPAN-HP 1 FL2000 100UM PET C1S, RT105 AS MANUFACTURED IN AZ APELDOORN, THE NETHERLANDS SEMI-SYNTHETIC PACLITAXEL ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN RENSSELAER, NY ATHERO GENICS AGIX-4207 INJECTABLE EMULSION AS MANUFACTURED IN CLAYTON, NC BRIMONIDINE TARTRATE AS MANUFACTURED IN CZECH REPUBLIC SILFAR S 184 AS MANUFACTURED IN NUNCHRITZ CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN KARNATAKA STATE, INDIA. TECHNICAL GLASS BEADS AS MANUFACTURED IN WARMENSTEINACH, GERMANY PEPTO PINK MB20-4592 POLYETHYLENE COLOR CONCENTRATE AS MANUFACTURED IN COLBORNE, ONTARIO DIFFUCAPS PSEUDOEPHEDRINE HCL BULK PELLETS AS MANUFACTURED IN MILAN, ITALY POLY(STYRENE/DIVINYLBENZENE) PARTICLES UNDER THE TRADENAMES PLRP-S AND RPC POLYBIO AS MANUFACTURED IN SHROPSHIRE, UK FLUMAZENIL AS MANUFACTURED IN TAINAN COUNTY,TAIWAN,R.O.C. POLY SLIK 111/80 CIS WITH GRADE CODE 76PQ AS MANUFACTURED N THE NETHERLANDS IS CHO-V AS MANUFACTURED IN SANTA ANA,CA LCF-9 A HOT STAMP INK RIBBON AS MANUFACTURED IN KALKASKA, MI METHOCARBAMOL AS MANUFACTURED IN TAIPEI HSIENG, TAIWAN, R.O.C. GATIFLOXACIN DRUG SUBSTANCE AS MANUFACTURED IN TOKYO,JAPAN NIMODIPINE 30MG SOFTGEL CAPSULES AS MANUFACTURED IN ST. PETERSBURG, FL. MKS-1 (AS INTERMEDIATE OF GATIFLOXACIN) AS MANUFACTURED IN SHIZUOKA,JAPAN

LEVOAMPHETAMINE SULFATE CODE 8890 AS MANUFACTURED IN ST.LOUIS,MO RISPERIDONE AS MANUFACTURED IN BE'ER SHEVA,ISRAEL AMPHETAMINE ASPARTATE AS MANUFACTURED IN ASSONET,MA AMPHETAMINE SULFATE AS MANUFACTURED IN ASSONET, MA DEXTROAMPHETAMINE SULFATE AS MANUFACTURED IN ASSONET, MA DEXTROAMPHETAMINE SACCHARATE AS MANUFACTURED IN ASSONET, MA METAXALONE AS MANUFACTURED IN WEST DEPTFORD,NJ

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4Q2012EXCEL DMF# 15610 15611 A 15612 15613 15614 15615 15616 A 15617 I 15618 A 15619 15620 I 15621 I 15622 I 15623 15624 15625 15626 15627 I 15628 15629 A 15630 I 15631 15632 15633 A 15634 I 15635 15636 15637 I 15638 A IV 9/24/2001 INTERNATIONAL SPECIALTY PRODUCTS A A II III III 9/20/2001 9/14/2001 9/24/2001 ZACH SYSTEM SPA KOREA ENGINEERING PLASTICS CO LTD NATIONAL ADHESIVES III 9/17/2001 LAJOVIC TUBA EMBALAZA, D.D. A A III III III 9/17/2001 9/17/2001 9/21/2001 II 9/20/2001 DISHMAN PHARMACEUTICALS AND CHEMICAL PVT LTD POLYONE CORP POLYONE CORP APPLIED TECH PRODUCTS HEALTH AND BEAUTY CARE DIV TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN AHMEDABAD, INDIA CC00012694A2 AS MANUFACTURED IN VONORE, TN. CC00015291D4 AS MANUFACTURED IN VONORE, TN. A IV II 9/10/2001 9/17/2001 KYOWA CHEMICAL INDUSTRY CO LTD XELLIA PHARMACEUTICALS APS SYNTHETIC ALUMINUM SILICATE AS MANUFACTURED IN KAGAWA, JAPAN TOBRAMYCIN SULPHATE, USP STERILE BULK (ESUB) AS MANUFACTURED IN COPENHAGEN S, DENMARK A I I I II III III III II 9/7/2001 9/10/2001 9/11/2001 9/10/2001 9/18/2001 ACS DOBFAR SPA COGNIS GMBH COGNIS GMBH COGNIS GMBH TEVA GROUP IV 9/11/2001 FONA INTERNATIONAL INC IV 9/11/2001 FONA INTERNATIONAL INC A II IV 9/14/2001 9/11/2001 APOTEX PHARMACHEM INC FONA INTERNATIONAL INC QUINAPRIL HCL AS MANUFACTURED IN BRANTFORD, ONTARIO, CANADA II 9/7/2001 CORDEN PHARMA SWITZERLAND LLC III 9/5/2001 LPS INDUSTRIES INC C A A I II II II II III 8/25/2001 9/5/2001 9/3/2001 9/6/2001 9/6/2001 SUN PHARMACEUTICAL INDUSTRIES LTD SCINOPHARM TAIWAN LTD API CORP FERMIC SA DE CV WORF GLASKUGELN GMBH STATUS Type SUBMIT DATE A II II 9/4/2001 8/31/2001 HOLDER CADILA HEALTHCARE LTD YUHAN CHEMICAL INC SUBJECT MIDODRINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA.

4Q2012

RIBAVIRIN USP, 1H-1,2,4-TRIAZOLE-3-CARBOXAMIDE, 1-B-D-RIBOFURANOSYL- AS MANUFACTURED IN KYUNGGI-DO, KOREA METFORMIN HYDROCHLORIDE E.P/B.P AS MANUFACTURED IN MAHARASTHRA, INDIA FLAVOXATE HYDROCHLORIDE AS MANUFACTURED IN TAIWAN, R.O.C. METHYL SALICYLATE AS MANUFACTURED IN FUKUOKA, JAPAN CLARITHROMYCIN AS MANUFACTURED IN MEXICO CITY, MEXICO TECHNICAL 2.5 MM DIAMETER GLASS BEADS AS MANUFACTURED IN MAINZ AND BAISWEIL, FEDERAL REPUBLIC OF GERMANY VF42, (POLYESTER/FOIL/LLDPE LAMINATION) AS MANUFACTURED IN MOONACHIE, NEW JERSEY SODIUM CHOLESTERYL SULFATE (SCS) AS MANUFACTURED IN LEISTAL, SWITZERLAND

#921.060 TANGERINE ORANGE FLAVOR, NATURAL (WONF) AS MANUFACTURED IN CAROL STREAM, ILLINOIS #936.751 NATURAL AND ARTIFICIAL DEBITTERING FLAVOR AS MANUFACTURED IN CAROL STREAM, ILLINOIS #894-088 N-C INTENSE PEPPERMINT FLAVOR, NATURAL (WONF) AS MANUFACTURED IN CAROL STREAM, ILLINOIS SODIUM CARBONATE LYOPHILIZED STERILE AS MANUFACTURED IN MILANO, ITALY. LOXIOL G 70 S AS MANUFACTURED IN DUSSELDORF, GERMANY LOXIOL G 78 AS MANUFACTURED IN DUSSELDORF, GERMANY LOXIOL P 1141 AS MANUFACTURED IN DUSSELDORF, GERMANY NAPROXEN AND NAPROXEN SODIUM USP AS MANUFACTURED IN BE'ER SHEVA, ISRAEL

TRIGGER DISPENSER ASSEMBLY, C/R TUBE CLOSURE ASSEMBLY & SLIDE CASE ASSEMBLY AS MANUFACTURED IN SPARTA, NJ, WEST BERLIN, NJ, AND STRAFORD, CT INJECTION BLOW MOLDED PLASTIC BOTTLES AS MANUFACTURED IN LJUBJANA, SLOVENIA RIFAXIMIN AS MANUFACTURED IN VICENZA, ITALY KEPITAL F30-03 NATURAL AS MANUFACTURED IN SEOUL REPUBLIC, KOREA UV CURE ADHESIVE AS MANUFACTURED IN BRIDGEWATER, NJ & UNITED KINGDOM, ENGLAND GANEX V-220 (VP/EICOSENE COPOLYMER) AS MANUFACTURED IN CALVERT CITY, KY

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4Q2012EXCEL DMF# 15639 15640 15641 15642 15643 15644 15645 15646 A 15647 15648 A 15649 15650 I 15651 15652 A 15653 I 15654 15655 I 15656 15657 15658 15659 I 15660 A 15661 15662 I 15663 15664 15665 15666 15667 A 15668 I 15669 15670 A I IV II 10/10/2001 10/16/2001 NIPPON SHINYAKU CO LTD RANBAXY LABORATORIES LTD II 10/13/2001 AVANTI POLAR LIPIDS INC 1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHO-L-SERINE(SODIUM SALT) (DOPS) AS MANUFACTURED IN ALABASTER, AL CLZ-42 AS MANUFACTURED IN KYOTO, JAPAN CEFUROXIME ACID AS MANUFACTURED IN PUNJAB, INDIA I I A I II II II II II 10/10/2001 10/15/2001 10/16/2001 10/15/2001 10/15/2001 MALLINCKRODT INC RESOLUTION CHEMICALS LTD POLYCARBON INDUSTRIES INC SIFA LTD DSM PHARMA CHEMICALS NETHERLANDS BV I II II 10/12/2001 10/12/2001 GILEAD SCIENCES INC ELAN PHARMACEUTICAL TECHNOLOGIES IV 10/9/2001 CAPSUGEL I A I III III II II 9/28/2001 9/27/2001 10/8/2001 10/10/2001 POLIMERI EUROPA FRANCE SA EXXONMOBIL CHEMICAL SAS FERRO PFANSTIEHL LABORATORIES LUITPOLD PHARMACEUTICALS INC A II II 10/5/2001 6/22/2001 V 10/5/2001 CENTERS FOR DISEASE CONTROL AND PREVENTION POLYPEPTIDE LABORATORIES INC XINXIANG PHARMACEUTICAL CO LTD I II II 10/5/2001 10/8/2001 A II II 10/4/2001 9/25/2001 STERLING SRL I II IV 9/28/2001 10/5/2001 STATUS Type SUBMIT DATE A I I A A I I II II II II II III II II 9/21/2001 9/25/2001 10/1/2001 10/1/2001 10/1/2001 2/5/2001 10/4/2001 8/13/2001 HOLDER ASAHI KASEI PHARMA CORP CLARIANT LSM MISSOURI INC KOEI CHEMICAL CO LTD TEVA PHARMACEUTICAL INDUSTRIES LTD CHEMISCHE FABRIK BERG GMBH REXAM CONTAINERS LTD GLAXOSMITHKLINE ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD QUIMICA SINTETICA SA HAYASHIBARA CO LTD SUBJECT

4Q2012

FASUDIL HYDROCHLORIDE HYDRATE AS MANUFACTURED IN MIYAZAKI, JAPAN GAR-936 AS MANUFACTURED IN ORIGGIO (VA), ITALY PAA-HC1 [4-PIPERIDYL ACETIC ACID-HCL] AS MANUFACTURED IN OSAKA, JAPAN. ONDANSETRON HCL DIHYDRATE AS MANUFACTURED IN HUNGARY BUTALBITAL USP AS MANUFACTURED IN BITTERFIELD CONTINUOUS SCREW CLOSURES AS MANUFACTURED IN EVANSVILLE, IN HIV VACCINE (GPL 120/NEFTA/ASO2A) AS MANUFACTURED IN BELGIUM SULFADIMETHOXINE USP AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA BENAZEPRIL HYDROCHLORIDE AS MANUFACTURED IN MADRID, SPAIN HAYASHIBARA MALTOSE MONOHYDRATE FOR INJECTION AS MANUFACTURED IN OKAYAMA, JAPAN NORGESTIMATE AS MANUFACTURED IN PERUGIA, ITALY

FMC CORPORATION, HYDROGEN PEROXIDE HYDROGEN PEROXIDE AS MANUFACTURED IN SOUTH CHARLESTON, WV AND DIVISION PASADENA, TX BRISTOL MYERS SQIBB COMPANY ARIPIPRAZOLE TABLETS AS MANUFACTURED IN MAYAGUEZ, PUERTO RICO SANOFI CHIMIE PREDNISOLONE SODIUM METASULFOBENZOATE AS MANUFACTURED IN VERTOLAYE, FRANCE PROVISIONAL DATA REPORT ON MALARIA SURVEILLANCE AND USE OF ANTIMALARIAL CHEMOPROPHYLAXIS AS MANUFACTURED IN ATLANTA, GA PORCINE SECRETIN, ACETATE AS MANUFACTURED IN TORRANCE, CA RIBAVIRIN NON-STERILE BULK FORM AS MANUFACTURED IN HENAN PROVINCE, P.R. CHINA RIBLENE MP20 AS MANUFACTURED IN DUNKIRK, FRANCE POLYPROPYLENE HOMOPOLYMER AS MANUFACTURED IN LILLEBONNE, FRANCE TOPIRAMATE AS MANUFACTURED IN WAUKEGAN, IL SODIUM CHLORIDE INJECTION 0.9% 4ML FILL IN A 5ML VIAL AS MANUFACTURED IN SHIRLEY, NY CAPSULE FOR INHALATION FOR BOEHRINGER INGELHEIM AS MANUFACTURED IN BORNEM, BELGIUM FK506LC AND PLACEBO AS MANUFACTURED IN SAN DIMAS, CA BUDESONIDE NANOCRISTAL COLLOIDAL DISPERSION AS MANUFACTURED IN HORSHAM, PA NALMEFENE HYDROCHLORIDE AS MANUFACTURED IN ST. LOUIS, MO AZOTHIAPRINE USP AS MANUFACTURED IN THE UNITED KINGDOM PYRIDOSTIGMINE BROMIDE USP AS MANUFACTURED IN LEOMINSTER, MA BMS 20783-01 AS MANUFACTURED IN REPUBLIC OF IRELAND FLUMOL 50(35-60% FLUMOL IN ACETONITRIL) (ESUB) AS MANUFACTURED IN NETHERLANDS

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4Q2012EXCEL DMF# 15671 15672 15673 15674 15675 15676 15677 15678 15679 15680 15681 A 15682 15683 15684 15685 A 15686 15687 15688 I 15689 15690 15691 15692 15693 15694 15695 15696 15697 I 15698 15699 15700 A 15701 C 15702 15703 15704 I 15705 I III 10/29/2001 AMPACET CORP I I III III III 10/23/2001 10/25/2001 10/29/2001 ROLLPRINT PACKAGING PRODUCTS, INC ROLLPRINT PACKAGING PRODUCTS INC AMPACET CORP II 11/2/2001 I A II II II 10/31/2001 11/2/2001 10/30/2001 RANBAXY LABORATORIES LTD DR REDDYS LABORATORIES LTD PRIME EUROPEAN THERAPEUTICS SPA EUTICALS SPA MYLAN LABORATORIES LTD A A A A A A I A III II III II II II III III III 10/19/2001 10/22/2001 10/25/2001 10/31/2001 10/31/2001 10/29/2001 4/24/2001 10/31/2001 10/22/2001 A A II II III 10/19/2001 10/29/2001 10/10/2001 SCINOPHARM TAIWAN LTD SIFAVITOR SRL BERRY PLASTICS CORP TAPES AND COATINGS DIV POLYONE CORP E BEGEROW GMBH AND CO SAINT-GOBIAN CALMAR, INC. CHEMAGIS LTD CIPLA LTD FINETECH PHARMACEUTICAL LTD BESPAK PLC RPC FORMATIC GMBH AMPACET CORP A I A II II II III 10/23/2001 10/24/2001 10/19/2001 10/23/2001 INKE SA FINORGA SA POLYPEPTIDE LABORATORIES AS ASO CO LTD STATUS Type SUBMIT DATE A A A I I A A I A A III II II III III II II III II II II 10/12/2001 10/15/2001 10/22/2001 10/9/2001 10/9/2001 10/19/2001 10/18/2001 10/22/2001 10/18/2001 10/22/2001 10/15/2001 HOLDER EASTMAN CHEMICAL CO QUIMICA SINTETICA SA INDUSTRIA QUIMICA ANDINA Y CIA. S.A. BASELL GMBH BASELL POLIOLEFINE ITALIA SPA FARCHEMIA SRL LEK PHARMACEUTICALS DD PENN COLOR INC LIFE TECHNOLOGIES CORPORATION APOTECNIA SA APTALIS PHARMA SRL SUBJECT EASTMAN 168 PLASTICIZER AS MANUFACTURED IN KINGSPORT, TN LEVOFLOXACIN AS MANUFACTURED IN MADRID, SPAIN ACETYLSALICYLIC ACID AS MANUFACTURED IN BOGOTA, COLOMBIA LUPOLEN 5621 DX AS MANUFACTURED IN FEDERAL REPUBLIC OF GERMANY LUPOLEN 5021 DX AS MANUFACTURED IN FEDERAL REPUBLIC OF GERMANY RANITIDINE HYDROCHLORIDE AS MANUFACTURED IN BERGAMO, ITALY LITHIUM CARBONATE ACTIVE SUBSTANCE AS MANUFACTURED IN SLOVENIA 66W42 WHITE AS MANUFACTURED IN HAFIELD, PA POROS CHROMATOGRAPHIC RESINS AS MANUFACTURED IN CAMBRIDGE, MA TERCONAZOLE AS MANUFACTURED IN BENIEL (MURCIA), SPAIN

4Q2012

PANCRELIPASE PRODUCTS (EURAND MINITABS) (HP55) AS MANUFACTURED IN MILANO, ITALY RISPERIDONE AS MANUFACTURED IN BARCELONA, SPAIN TMC 125 AS MANUFACTURED IN FRANCE CALCITONIN (SALMON) PH. EUR. AS MANUFACTURED IN DENMARK ASO CLEAN BAG, ASO CLEAN SHEET AND ASO CLEAN TUBE AS MANUFCTURED IN OSAKA, JAPAN FLUTICASONE PROPIONATE AS MANUFACTURED IN TAINAN,TAIWAN MEFLOQUINE HYDROCHLORIDE AS MANUFACTURED IN (LODI), ITALY IS PAPER/POLYETHYLENE/FOIL/EMAA TERPOLYMER AS MANUFACTURED IN HOMER, LA CC00022659X1 AS MANUFACTURED IN VONORE, TN. BECODISK LENTICULAR CARTRIDGES AS MANUFACTURED IN GERMANY ACCUPUMP SPRAY PUMP AS MANUFACTURED IN HEMER, GERMANY FLUMAZENIL AS MANUFACTURED IN BEER SHEVA, ISREAL TOPIRAMATE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN NESHER, ISRAEL ORAL ACTUATORS & CAPS AS MANUFACTURED IN APEX, NC HANDIHALER DEVICE AS MANUFACTURED IN GERMANY 7182288 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA, HEATH, OH OR LATEXO, TX LOVASTATION USP AS MANUFACTURED IN PRADESH, INDIA TIZANIDINE HCL AS MANUFACTURED IN ANDHRA PRADESH, INDIA RIBAVIRIN USP-BP AS MANUFACTURED IN ITALY TRAZODONE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN ANDHRA PRADESH,INDIA RPP #33-2021A AS MANUFACTURED IN ADDISON, IL AND BLOOMFIELD CT RPP#36-1026A AS MANUFACTURED IN ADDISON, IL & BLOOMFIELD, CT 701709-H FOAM POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA, HEALTH, OH OR LATEXO, TX 7012124 ANTIBLOCK POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN DERIDDER, LA, CARTERSVILLE, GA, HEALTH, OH OR LATEXO, TX

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4Q2012EXCEL DMF# 15706 15707 15708 I 15709 15710 15711 15712 15713 15714 A 15715 15716 15717 15718 15719 15720 15721 15722 15723 I 15724 A 15725 15726 15727 15728 15729 15730 15731 A 15732 15733 15734 15735 A 15736 A 15737 15738 15739 A 15740 A II 11/15/2001 LONZA AG CN 28091 LACTOL-LACTAM AS MANUFACTURED IN SWITZERLAND A A II II II 11/21/2001 11/26/2001 11/12/2001 BASF PHARMA EVIONNAZ SA TEVA PHARMACEUTICAL INDUSTRIES LTD UNICHEM LABORATORIES LTD III 11/19/2001 TEKNOR COLOR CO A A A II III II III 11/15/2001 11/21/2001 11/19/2001 11/19/2001 MYLAN LABORATORIES LTD HI TECH RUBBER INC JM HUBER CORP TEKNOR COLOR CO A I A A A A II II II II II II II 11/14/2001 11/16/2001 10/31/2001 11/14/2001 11/15/2001 11/14/2001 11/14/2001 SAFC BIOSCIENCES INC SUGAI CHEMICAL INDUSTRY CO LTD SUN PHARMACEUTICAL INDUSTRIES LTD HETERO DRUGS LTD LONZA LTD HETERO DRUGS LTD HETERO DRUGS LTD II 11/15/2001 CIPLA LTD I A A A A A A A II III III III III II II II III 11/12/2001 11/5/2001 11/5/2001 11/5/2001 11/5/2001 11/13/2001 11/13/2001 11/7/2001 11/15/2001 I N I A I II IV IV II 11/8/2001 11/12/2001 11/12/2001 11/6/2001 II 11/8/2001 STATUS Type SUBMIT DATE I A II III II 11/8/2001 10/25/2001 10/31/2001 HOLDER CIPLA LTD FUJIMORI KOGYO CO LTD NINGBO TRADITIONAL CHINESE PHARMACEUTICAL FACTORY BIOMEDISYN CORPORATION NOT AN ASSIGNED NUMBER LC UNITED CHEMICAL CORPORATION NATIONAL STARCH LLC NATIONAL STARCH CHEMICAL CO KREBS BIOCHEMICALS AND INDUSTRIES LTD DOCTOR REDDYS LABORATORIES LTD POLYONE CORP POLYONE CORP POLYONE CORP POLYONE CORP SANDOZ GMBH SIGNA SA DE CV RANBAXY LABORATORIES LTD UCB FILMS, INC. BROMPHENIRAMINE AS MANUFACTURED IN THE REPUBLIC OF CHINA UNIPURE WG-220 AS MANUFACTURED IN INDIANAPOLIS, IN UNIPURE WG-225 AS MANUFACTURED IN INDIANAPOLIS, IN PSEUDOEPHEDRINE HCL-USP AS MANUFACTURED IN HYDERABAD, INDIA CLOPIDOGREL BISULFATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CC00000987WE AS MANUFACTURED IN VONORE, TN. CC00000985WE AS MANUFACTURED IN VONORE, TN. PRODUCT NUMBER 10016620 AS MANUFACTURED IN GLENDALE, AZ CC00018782WE/60 AS MANUFACTURED IN VONORE, TN. RAPAMYCIN AS MANUFACTURED IN AUSTRIA CLOPIDOGREL BISULPHATE AS MANUFACTURED IN TOLUCA, MEXICO SIMVASTATION USP AS MANUFACTURED IN PUNJAB, INDIA SUBJECT SALMETEROL XINAFOATE AS MANUFACTURED IN MAHARASHTA, INDIA PLASTIC SHEET AS MANUFACTURED IN JAPAN (-)-HUPERZINE A AS MANUFACTURED IN NINGBO, ZHEJIANG, P.R. CHINA (-)-HUPERZINE A AS IMPORTED BY BIOMEDISYN IN WOODBRIDGE, CT

4Q2012

BIAXIALLY ORIENTED POLYPROPYLENE (BOPP) FILMS AS MANUFACTURED IN UNITED KINGDOM, BELGIUM & AUSTRALIA ONDANSETRON HCL USP (ESUB) AS MANUFACTURED IN INDIA EX-CELL 302 MEDIUM (MODIFIED) CAT. #62630 AS MANUFACTURED IN DENVER, PA SMAP (BROMOSULFONE) AS MANUFACTURED IN FUKUI, JAPAN TIZANIDINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA ITRACONAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CN25225 (METEXAFIN GADOLINIUM) AS MANUFACTURED IN SWITZERLAND TIZANIDINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA SERTRALINE HCL USP (FORM II PROCESS I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA NAPROXEN SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH,INDIA MEDICAL COMPONENTS AS MANUFACTURED IN ANAHEIM, CA CALCIUM CARBONATE AS MANUFACTURED IN QUINCY, IL 61,579HCPP MAROON 33:1 AS MANUFACTURED IN HENDERSON, KY, CUMBERLAND, RI, JACKSONVILLE, TX, LODI, OH, FOOUNTAIN INN, SC & INDUSTRY, CA 90,699 HCC WHITE 1% AS MANUFACTURED IN HENDERSON, KY, CUMBERLAND, RI, JACKSONVILLE, TX, LODI, OH, FOUNTAIN INN, SC & INDUSTRY, CA BETHANECHOL CHLORIDE AS MANUFACTURED IN SWITZERLAND TORSEMIDE AS MANUFACTURED IN ZAGREB, CROATIA TIZANIDINE HCL USP (ESUB) AS MANUFACTURED IN INDIA

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4Q2012EXCEL DMF# 15741 I 15742 15743 15744 I 15745 15746 15747 I 15748 15749 15750 15751 A 15752 15753 15754 15755 15756 15757 15758 15759 15760 15761 15762 A 15763 15764 I 15765 15766 15767 15768 15769 15770 15771 15772 15773 15774 15775 A 15776 A II 12/21/2001 RANBAXY LABORATORIES LTD I A I I A A A A A A II III II III II II II II III II V 12/10/2001 11/23/2001 12/14/2001 12/14/2001 12/14/2001 12/14/2001 12/17/2001 12/18/2001 12/14/2001 12/19/2001 12/17/2001 DIXIE CHEMICAL CO INC REXAM HEALTHCARE OFFRANVILLE SAS SMITHKLINE BEECHAM IWATA GLASS INDUSTRIAL CO., LTD. SANDOZ GMBH UNION QUIMICO FARMACEUTICA SA INDUSTRIALE CHIMICA SRL WATSON PHARMA PRIVATE LTD NYPRO INC CIPLA LTD INTERNATIONAL SPECIALTY PRODUCTS I III III 12/3/2001 12/5/2001 CKS PACKAGING, INC. AMPACET CORP A I A A A A A I N I II III 11/30/2001 12/12/2001 II II II III II II II II 12/5/2001 12/3/2001 12/6/2001 11/8/2001 10/1/2001 12/5/2001 11/27/2001 12/11/2001 CAMBREX CHARLES CITY INC KREBS BIOCHEMICALS LTD DOTTIKON EXCLUSIVE SYNTHESIS AG AMCOR FLEXIBLES ITALIA SRL BIDACHEM SPA DR REDDYS LABORATORIES LTD PIRAMAL HEALTHCARE UK LTD DIOSYNTH BV NOT AN ASSIGNED NUMBER MDS NORDION S A BASELL USA, INC. THALLOUS (T1-201) CHLORIDE AS MANUFACTURED IN FLEURUS, BELGIUM A A A II II II III 12/3/2001 12/5/2001 12/6/2001 12/7/2001 NORAC CO INC MEDICHEM SA TARO PHARMACEUTICAL INDUSTRIES LTD LOPAREX LLC C I II II III 11/29/2001 12/3/2001 11/27/2001 C I II II II 11/12/2001 11/30/2001 12/3/2001 TEVA PHARMACEUTICAL INDUSTRIES LTD BOEHRINGER INGELHEIM LTD SANOFI CHIMIE (A SUBSIDIARY OF SANOFIAVENTIS) TEVA PHARMACEUTICAL INDUSTRIES LTD DR REDDY'S LABORATORIES LTD AMPACET CORP STATUS Type SUBMIT DATE III 10/29/2001 HOLDER AMPACET CORP SUBJECT

4Q2012

7010778 AB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA, HEATH, OH OR LATEXO, TX FLUDARABINE PHOSPHATE AS MANUFACTURED IN MILAN, ITALY ESMOLOL HCL AS MANUFACTURED IN PETERSBURG, VA ZOPICLONE AS MANUFACTURED IN CEDEX, FRANCE FLUTICASONE PROPIONATE AS MANUFACTURED IN MEXICO AMLODIPINE MALEATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA 11078-A WHITE ANTISTAT AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA, HEATH, OH OR LATEXO, TX HYDROUS BENZOYL PEROXIDE, USP AS MANUFACTURED IN AZUSA, CA MIRTAZAPINE AS MANUFACTURED IN GIRONA, SPAIN HYDROCORTISONE 17-BUTYRATE, USP AS MANUFACTURED IN HAIFA BAY, ISRAEL GRADE 22421 D 5 MIL WH PET A10/000 AS MANUFACTURED IN IOWA CITY, IA, EDEN, NC, DIXON, IL & CULLMAN, AL ONDANSETRON HCL AS MANUFACTURED IN CHARLES CITY, IA L-EPHEDRINE HCL-USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA DB5, IP-DB5 AS MANUFACTURED IN SWITZERLAND FLEXIBLE PACKAGING MATERIAL FOR DRUG AS MANUFACTURED IN VICENZA, ITALY RIBAVIRIN AS MANUFACTURED IN BERGAMO, ITALY FEXOFENADINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CLOPROSTENOL SODIUM AS MANUFACTURED IN GRANGEMOUTH, UK ESTRADIOL GLUCOSIDE AS MANUFACTURED IN OSS, THE NETHERLANDS

PDC1273, PDC1274, PDC1284, PDC1287, PDC1288, PRO-FAXPH433 AND PRO-FAXPH133 HIGH DENSITY POLYETHYLENE BOTTLES AS MANUFACTURED IN MOORESVILLE, NC 10090 SLIP POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA, HEATH, OH, OR LATEXO, TX TP1 AS MANUFACTURED IN PASADENA, TX EYE-DROPPER SETS AS MANUFACTURED IN OFFRANVILLE, FRANCE L-DM1 AS MANUFACTURED IN LANEXA, KANSAS AND LOWER HUTT, NEW ZEALAND DRUG AMPULES AND VIALS AS MANUFACTURED IN OSAKA, JAPAN CEFUROXIME N-BUTYL AMMONIUM AS MANUFACTURED IN TYROL, AUSTRIA FLUOXETINE HCL AS MANUFACTURED IN BARCELONA, SPAIN DESOGESTREL AS MANUFACTURED IN VARESE, ITALY PRILOCAINE BP AS MANUFACTURED IN MAHARASHTRA, INDIA METERED DOSE POWDER INHALER AS MANUFACTURED IN ARDEN, NC FLUTICASONE PROPIONATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA TOXICOLOGY STUDIES ON PHARMASOLVE (N-METHYL-2-PYRROLIDONE) AS MANUFACTURED IN WAYNE, NJ BENAZEPRIL HYDROCHLORIDE AS MANUFACTURED IN PUNJAB,INDIA

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4Q2012EXCEL DMF# 15777 15778 A 15779 15780 I 15781 A 15782 A 15783 15784 15785 15786 A 15787 A 15788 15789 15790 15791 I 15792 I 15793 15794 15795 15796 15797 I 15798 I 15799 I 15800 15801 A 15802 15803 A 15804 A 15805 I II 1/15/2002 II 1/9/2002 I II II 1/8/2002 1/10/2002 A IV IV 1/8/2002 1/11/2002 NIPPON SHOKUBAI CO LTD DUPONT CHEMICALS AND FLUOROPRODUCTS CELSUS LABORATORIES INC IV 1/7/2002 FONA INTERNATIONAL INC III 12/14/2001 A A A A II II II III III 1/9/2002 12/27/2001 12/28/2001 12/13/2001 12/18/2001 ZACH SYSTEM SPA TARO PHARMACEUTICAL INDUSTRIES LTD RANBAXY LABORATORIES LTD COVALENCE COATED PRODUCTS BERRY PLASTICS CORP TAPES AND COATINGS DIV AMPACET CORP II 1/11/2002 BECTON DICKINSON AND CO I I I III II III II 12/21/2001 12/13/2001 12/19/2001 1/11/2002 STEDIM SA SANDOZ INDUSTRIAL PRODUCTS SPA DAR AMI LTD BECTON DICKINSON AND CO III 12/20/2001 LAMEPLAST SPA I I I II III III III 12/18/2001 12/14/2001 12/14/2001 12/18/2001 CHEMSOURCE CORP POLIMERI EUROPA FRANCE SA POLIMERI EUROPA FRANCE SA REXAM HEALTHCARE III 12/20/2001 3M PHARMACEUTICALS DIV III 12/20/2001 3M DRUG DELIVERY SYSTEMS I IV II 12/18/2001 12/20/2001 FERRO PFANSTIEHL DAIICHI SANKYO CO LTD STATUS Type SUBMIT DATE C II II 12/21/2001 12/28/2001 HOLDER TEVA PHARMACEUTICAL INDUSTRIES LTD CIPLA LTD SUBJECT AMLODIPINE BESYLATE AS MANUFACTURED IN GUAYAMA,PUERTO RICO

4Q2012

FINASTERIDE USP (ESUB) AS MANUFACTURED IN RAIGAD ,BANGALORE, PUNE, MUMBAI, INDIA SUCROSE ACETATE ISOBUTYRATE AS MANUFACTURED IN WAUKEGAN,IL DATICHI PHARMACEUTICAL CO LTD DU-6859A AS MANUFACTURED IN EDOGAWAKU,TOKYO,JAPAN SCOTCHPAK 9744 RELEASE LINER AS MANUFACTURED IN COTTAGE GROVE, MN, NEVADA, MO, ST.PAUL, MN, WEST ST.PAUL, MN, DECATUR, AL, GREENVILLE, SC COTRAN 9701, POLYURETHANE NONWOVEN BACKING AS MANUFACTURED IN BROOKING, SD ONDANSETRON HCL AS MANUFACTURED IN GUAYAMA,PUERTO RICO ERACLENE BB82 AS MANUFACTURED IN BRINDISI,ITALY ERACLENE MP90 AS MANUFACTURED IN PORTO TORRES,ITALY INJECTION MOLDED PLASTIC BOTTLES,CLOSURES,AND SPECIALTY ITEMS AS MANUFACTURED IN FRANKLIN,IN NON STERILE MONODOSE PRIMARY PLASTIC PACKAGING COMPONENT FOR AN ORAL VACCINE AS MANUFACTURED IN MODENA, ITALY STEDIM 100 BAG AS MANUFACTURED IN AUBAGNE CEDEX,FRANCE ERYTHROMYCIN ETHYLSUCCINATE AS MANUFACTURED IN TRENTO,ITALY ALUMINIUM TUBING AND PLASTIC CAPS AS MANUFACTURED IN KONYS, TURKEY BD CELL MAB MEDIUM BASE W/O PHENOL RED AS MANUFACTURED IN SPARKS, COCKEYSVILLE, MD AND HERNDON, VA BD CELL MAB MEDIUM, QUANTUM YIELD AS MANUFACTURED IN COCKEYSVILLE, MD AND HERNDON, VA PROPOFOL AS MANUFACTURED IN VICENZA, ITALY AMIODARONE HCL AS MANUFACTURED IN HAIFA BAY,ISRAEL CEFUROXIME AXETIL USP AS MANUFACTURED IN PUNJAB,INDIA PRODUCT 24-1-064 AS MANUFACTURED IN HOMER, LA 48 GAUGE CHEMICALLY TREATED POLYESTER/0.8#ADHESIVE/0.00032 FOIL/0.8#ADHESIVE/3.25 MIL LLDPE FILM 100388 AB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, TARRYTOWN, NY, CARTERSVILLE, GA, LATEXO, TX, HEATH, OH, MESSANCY, BELGIUM #918.011 SWEET-AM (AN ARTIFICIAL FLAVOR) AS MANUFACTURED IN CAROL STREAM, IL AQUALIC AS58 AN EXCIPIENT AS MANUFACTURED IN HYOGO PREFECTURE, JAPAN INHALATION GRADE 1,1,1,2,3,3,3 HEPTAFLUOROPROPANE AS MANUFACTURED IN EL DORADO, AR HEPARIN CALCIUM AS MANUFACTURED IN CINCINNATI, OH

JOHNSON MATTHEY PHARMACEUTICAL AURANOFIN AS MANUFACTURED IN WEST DEPTFORD, NJ MATERIALS UNION QUIMICO FARMACEUTICA SA UQUIFA OMEPRAZOLE (SIEVED) AS MANUFACTURED IN BARCELONA, SPAIN SA BACHEM INC THROMBIN RECEPTOR ACTIVATED PEPTIDE (TRAP) 508 (BULK) AS MANUFACTURED IN TORRANCE, CA Page 465

4Q2012EXCEL DMF# 15806 15807 15808 A 15809 15810 15811 15812 15813 I 15814 15815 15816 15817 15818 I 15819 I 15820 A 15821 15822 15823 15824 15825 15826 15827 15828 15829 A 15830 A 15831 15832 15833 A 15834 A 15835 15836 15837 15838 A I I A IV II II II 1/31/2002 1/31/2002 1/31/2002 1/29/2002 CAPSUGEL SUMITOMO CHEMICAL CO LTD MALLINCKRODT INC BIA SEPARATIONS DOO IV 1/31/2002 CAPSUGEL A A II III III 1/30/2002 1/29/2002 12/19/2001 RHODIA USINE DE MULHOUSE DORNACH REXAM PHARMA GMBH LONSTROFF AG III 1/23/2002 CORMACK PACKAGING PTY LTD A A I A I A A I II II II II IV III III II II 1/24/2002 1/23/2002 1/24/2002 1/24/2002 12/3/2001 1/21/2002 1/23/2002 1/23/2002 1/28/2002 II 1/22/2002 ACTAVIS PHARMA MANUFACTURING PRIVATE LTD USV LIMITED TARO PHARMACEUTICAL INDUSTRIES LTD ESTEVE QUIMICA SA SANDOZ GMBH DERIVADOS MACROQUIMICOS SA DE CV SEALED AIR CORP POLYONE CORP IRVINE SCIENTIFIC SALES CO ANTIBIOTICOS SA II 1/23/2002 I A A A II II II II IV 12/3/2001 1/21/2002 1/22/2002 1/17/2002 1/14/2002 KREBS BIOCHEMICALS LTD SANDOZ PRIVATE LTD DOTTIKON EXCLUSIVE SYNTHESIS AG PCAS HANGZHOU NANHANG INDUSTRIAL TRADE CO LTD LIPHA SAS I I I I II II II II II 1/10/2002 1/10/2002 1/14/2002 1/17/2002 1/17/2002 GRANULES INDIA LTD GRANULES INDIA LTD PCAS EGIS PHARMACEUTICALS PUBLIC LTD CO CIPLA LTD COMPRESSO PAP 90CPC AS MANUFACTURED IN HYDERABAD, INDIA COMPRESSO PAP 90CPF AS MANUFACTURED IN HYDERABAD, INDIA CLOMIPRAMINE HCL AS MANUFACTURED IN LIMAY, FRANCE DERAMCICLANE FUMARATE AS MANUFACTURED IN BUDAPEST, HUNGARY STATUS Type SUBMIT DATE A A IV IV IV 12/7/2001 12/7/2001 12/7/2001 HOLDER SUBJECT

4Q2012

HENRY H OTTENS MANUFACTURING CO INC ARTIFICIAL BUBBLE GUM FLAVOR #3266-P AS MANUFACTURED IN PHILADELPHIA, PA HENRY H OTTENS MANUFACTURING CO INC ARTIFICIAL STRAWBERRY FLAVOR #5532 AS MANUFACTURED IN PHILADELPHIA, PA HENRY H OTTENS MANUFACTURING CO INC ARTIFICIAL SWEETNESS ENHANCER #5401-B AS MANUFACTURED IN PHILADELPHIA, PA

CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN PUNE, BANGALORE, RAIGAD, MUMBAI, INDIA PSUEDOEPHEDRINE SULFATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA CEFUROXIME AXETIL AS MANUFACTURED IN MAHARASHTRA, INDIA 5-METHOXYINDOL-3-ALDEHYDE AS MANUFACTURED IN DOTTIKON, SWITZERLAND TRIMEPRAZINE TARTRATE AS MANUFACTURED IN LIMAY, FRANCE POVIDONE USP AS MANUFACTURED IN NANJING, CHINA HOMOTAURINE (CALCIUM ACAMPROSATE INTERMEDIATE) AS MANUFACTURED IN CALAIS, PITHIVIERS, FRANCE TIZANIDINE HYDROCHLORIDE AS MANUFACTURED IN KANCHIPURAM DISTRICT, INDIA GLYBURIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA FLUCONAZOLE AS MANUFACTURED IN HAIFA BAY, ISRAEL ADATANSERIN HYDROCHLORIDE (CRUDE) AS MANUFACTURED IN BARCELONA, SPAIN MYCOPHENOLIC ACID AS MANUFACTURED IN TYROL, AUSTRIA METHYL CELLULOSE AS MANUFACTURED IN MICHOACAN, MEXICO CRYOVAC M916 MEDICAL CONNECTOR TUBING AS MANUFACTURED IN CLAYTON, NC CC00018103WE AS MANUFACTURED IN VONORE, TN. IS CHO-V(TM) (P) AS MANUFACTURED IN SANTA ANA, CA 7-AMINO-DEACETOXY-CEPHALOSPORANIC ACID (7ADCA) AS MANUFACTURED IN LEON, SPAIN THE CORMACK RING SEAL AND STANDARD CLOSURES PLAIN OR LINED AS MANUFACTURED IN NEW SOUTH WALES, AUSTRALIA PARATRIFLUOROMETHOXYANILINE AS MANUFACTURED IN MULHOUSE, FRANCE MULTI DOSE POWDER INHALER (MDPI) AS MANUFACTURED IN NEUENBERG, GERMANY FLUOROELASTOMER RUBBER COMPOUND F5028Q BLACK AS MANUFACTURED IN AARAU, SWITZERLAND EMPTY HARD CAPSULES FROM HYDROXYPROPYLMETHYLCELLULOSE (HYPROMELLOSE) AS MANUFACTURED IN COLMAR, FRANCE POLYSACCHARIDE EMPTY HARD CAPSULES AS MANUFACTURED IN COLMAR, FRANCE CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN GIFU PREFECTURE, JAPAN NALTREXONE METHOBROMIDE (ESUB) AS MANUFACTURED IN ST.LOUIS, MO CIM CONVECTIVE INTERACTION MEDIA(R) DEAE AS MANUFACTURED IN LJUBLJANA, SLOVENIA

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4Q2012EXCEL DMF# 15839 A 15840 15841 15842 15843 15844 15845 15846 15847 15848 15849 15850 15851 15852 15853 15854 15855 15856 15857 15858 15859 A 15860 15861 15862 A 15863 15864 A 15865 15866 15867 15868 15869 A 15870 15871 15872 15873 15874 15875 I I I I A I III II II II II II 2/5/2002 2/6/2002 2/19/2002 2/19/2002 2/26/2002 2/22/2002 COLORS FOR PLASTICS AVI BIOPHARMA INC INDENA SPA API CORP SHASUN PHARMA SOLUTIONS LTD BENTLEY API SL A A A I II II II III IV 2/20/2002 2/18/2002 5/20/2002 2/18/2002 2/20/2002 TEVA PHARMACEUTICAL INDUSTRIES LTD SERATEC SARL TCI AMERICA ROLLPRINT PACKAGING PRODUCTS INC DURECT CORP A II II 2/18/2002 2/15/2002 SIGMA ALDRICH CO LTD CIPLA LTD MEBROFENIN AS MANUFACTURED IN DORSET, UNITED KINGDOM I A III IV II 2/8/2002 2/19/2002 2/19/2002 I A A I A A A A I A A A A I A I A I I II II II III III III II II II II II IV II III III III III III II II 1/31/2002 2/4/2002 11/20/2001 1/23/2002 2/5/2002 2/5/2002 2/6/2002 2/4/2002 1/31/2002 2/1/2002 2/2/2002 2/6/2002 1/31/2002 2/5/2002 2/12/2002 12/17/2002 2/5/2002 5/24/2002 2/12/2002 2/12/2002 QUIMICA SINTETICA SA SIGNA SA DE CV SALSBURY CHEMICALS INC BLEN COLOR INC TAKETOMO INC GRAND POLYMER CO LTD SRI KRISHNA PHARMACEUTICALS LTD UNICHEM LABORATORIES LTD DIVIS LABORATORIES LTD IPCA LABORATORIES LTD IPCA LABORATORIES LTD MANTROSE HAEUSER CO INC MEISSNER FILTRATION PRODUCTS INC COLORS FOR PLASTICS WACKER CHEMICAL CORP COLORS FOR PLASTICS QENOS PTY LTD POLYTECH SOUTH INC CHEMI SPA JUHUA GROUP CORP PHARMACEUTICAL FACTORY PARYLENE COATING SERVICES INC WACKER CHEMIE AG TARO PHARMACEUTICAL INDUSTRIES LTD ZOLPIDEM TARTRATE AS MANUFACTURED IN MADRID, SPAIN ALLOPURINOL USP AS MANUFACTURED IN TOLUCA, MEXICO DB5 AS MANUFACTURED IN CHARLES CITY, IOWA STATUS Type SUBMIT DATE II 1/25/2002 HOLDER SUBJECT HUBEI BIOCAUSE PHARMACEUTICAL CO LTD IBUPROFEN USP AS MANUFACTURED IN HUBEI PROVINCE, CHINA

4Q2012

16-03N AND 06-00 COLOR CONCENTRATES AS MANUFACTURED IN LEOMINSTER, MA ALUMINIUM FOR PRESS THROUGH PACKAGING AS MANUFACTURED IN TOKYO, JAPAN GRAND POLYPRO J235T AS MANUFACTURED IN YAMAGUICHI, JAPAN ACETAMINOPHEN USP (ESUB) AS MANUFACTURED IN HYDERABAD, INDIA BENDROFLUMETHIAZIDE (ESUB) AS MANUFACTURED IN RAIGAD, INDIA 5-PHENYLHYDANTOIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA PROPRANOLOL HYDROCHLORIDE AS MANUFACTURED IN DIST.RATLAM, INDIA METOPROLOL TARTRATE AS MANUFACTURED IN DIST.RATLAM, INDIA CERTISEAL A-100 AS MANUFACTURED IN ATTLEBORO, MA STERILUX AND STERIDYNE FILTER ELEMENTS AS MANUFACTURED IN CAMARILLO, CA COLORS FOR PLASTICS I.D.: B 18854 AS MANUFACTURED IN ELK GROVE VILLAGE, IL VINNOL(R) H 15/45 M AS MANUFACTURED IN BURGHAUSEN, GERMANY B20035 AS MANUFACTURED IN ELK GROVE VILLAGE, IL. ULTRA J225 LDPE AS MANUFACTURED IN MATRAVILLE, NSW, AUSTRALIA MASTER BACHES AS MANUFACTURED IN LAPORTE, TX. SODIUM ALENDRONATE AS MANUFACTURED IN FROSINONE, ITALY IBUPROFEN AS MANUFACTURED IN ZHEJIANG, CHINA PARYLENE COATING AS MANUFACTURED IN KAY, TX SILFAR(R) SE 4 AS MANUFACTURED IN NUNCHRITZ, GERMANY DIFLORASONE DIACETATE USP MICRONIZED AS MANUFACTURED IN HAIFA BAY, ISRAEL

LEVOFLOXACIN HEMIHYDRATE (ESUB) AS MANUFACTURED IN BANGALORE, RAIGAD, POONA, INDIA CARVEDILOL AS MANUFACTURED IN BE'ER SHEVA, NETANYA, PETAH TIQVA, ISRAEL BETHANECHOL CHLORIDE USP AS MANUFACTURED IN COURVILLE SUR EURE, FRANCE BMIPP FINAL INTERMEDIATE AS MANUFACTURED IN PORTLAND, OR. RPP#36-1085B AS MANUFACTURED IN ADDISON, IL AND BLOOMFIELD, CT POLYLACTIDE, POLYGLYCOLIDE, AND POLYCAPROLACTONE POLYMERS AND COPOLYMERS AS MANUFACTURED IN PELHAM, ALABAMA COLORS FOR PLASTICS I.D.: B18855 AS MANUFACTURED IN ELK GROVE VILLAGE, IL AVI 4126 AS MANUFACTRUED IN PORTLAND, OR IDN 5109 AS MANUFACTURED IN SETTALA, ITALY MCC-555 AS MANUFACTURED IN FUKUROI-CITY, JAPAN ACRIVASTINE AS MANUFACTURED IN NORTHUMBERLAND, ENGLAND METHOCARBAMOL AS MANUFACTURED IN PINSEQUE, SPAIN

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4Q2012EXCEL DMF# 15876 15877 15878 A 15879 15880 15881 15882 A 15883 15884 15885 A 15886 A 15887 15888 A 15889 15890 A 15891 15892 I 15893 15894 A 15895 15896 I 15897 A 15898 15899 I 15900 15901 I 15902 I 15903 I 15904 I III 3/11/2002 COLOR MASTER INC III 3/11/2002 COLOR MASTER INC III 3/11/2002 COLOR MASTER INC A II II 3/15/2002 3/15/2002 I IV II 3/6/2002 3/15/2002 SYMRISE INC SHANGHAI ZHONGHUA PHARMACEUTICAL FACTORY RELIABLE BIOPHARMACEUTICAL CORP BAYER CORP II 3/14/2002 SAFC BIOSCIENCES INC A IV III 3/12/2002 3/4/2002 SEPPIC SA BASELL AUSTRALIA PTY LTD I III IV 3/12/2002 3/8/2002 SHINKO CHEMICAL CO LTD CAPSCANADA CORP SK-MODEL BOTTLE AS MANUFACTURED IN ISHIKAWA, JAPAN I III III 3/5/2002 3/11/2002 I II II 3/5/2002 3/8/2002 FARCHEMIA SRL AVENTIS PHARMA MANUFACTURING PTE LTD POLIMERI EUROPA FRANCE SA WINPAK TECHNOLOGIES INC A II IV 3/6/2002 3/4/2002 DR REDDYS LABORATORIES LTD ROBERTET FLAVORS INC II 2/28/2002 ISOCHEM SAS I A II III III 3/4/2002 2/25/2002 3/5/2002 A I I II IV IV II 2/27/2002 2/27/2002 2/27/2002 2/13/2002 TEVA PHARMACEUTICAL INDUSTRIES LTD MANTROSE HAEUSER CO INC MANTROSE HAEUSER CO INC CHONGQING CARE LIFE PHARMACEUTICAL CO LTD GEDEON RICHTER ACG PHARMAPACK PVT LTD STYROLUTION KOLN GMBH STATUS Type SUBMIT DATE I I IV II III 2/25/2002 4/8/2002 2/25/2002 HOLDER ROHM AND HAAS CO INDUSTRIALE CHIMICA SRL CCL CONTAINER CORP SUBJECT

4Q2012

SUNSPHERES(TM) LCG AND PGL POLYMER AS MANUFACTURED IN CROYDON, PA BUDESONIDE AS MANUFACTURED IN SARONNO, ITALY ALUMINUM AEROSOL CANS, ALUMINUM BOTTLES AND OTHER NON-AEROSOL RIGID PACKAGING, ALUMINUM PISTON BARRIER PACKAGING AS MANUFACTURED IN HERMITAGE, PA AND PENETANG, ON MITOXANTRONE HYDROCHLORIDE USP AS MANUFACTURED IN LERMA, EDO. MEXICO CERTISEAL FC-300 AS MANUFACTURED IN ATTLEBORO, MA CERTISEAL FC-300 AS MANUFACTURED IN ATTLEBORO, MA GLIMEPIRIDE AS MANUFACTURED IN CHONGQING, CHINA FLUCONAZOLE AS MANUFACTURED IN BUDAPEST AND DOROG, HUNGARY BLISTER FILMS AS MANUFACTURED IN MAHARASHTRA, INDIA LUSTRAN ABS M 203 FC VARIOUS AS MANUFACTURED IN DORMAGEN, GERMANY; FILAGO, ITALY AND TARAGONA, SPAIN PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN GENEVILLIERS, FRANCE TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA NATURAL SPRAY DRIED SPEARMINT FLAVOR NV-9466 AS MANUFACTURED IN PISCATAWAY, NJ OXCARBAZEPINE AS MANUFACTURED IN TREVIGLIO, ITALY CROMOLYN SODIUM AS MANUFACTURED IN SINGAPORE SINKRAL L 320 BLUE 14390 AS MANUFACTURED IN RAVENNA, ITALY PACKAGING PHARMACEUTICAL PRODUCTS AS MANUFACTURED IN TORONTO, CANADA

TWO PIECE EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN TECUMSEH, CANADA MONTANIDE ISA 720 VG AS MANUFACTURED IN CASTRES, FRANCE MOPLEN HP 400 L AS MANUFACTURED IN ROSEHILL, NSW AND CORIO, VIC, AUSTRALIA JRH BIOSCIENCES EX-CELL(TM) 325 PF CHO PROTEIN-FREE MEDIUM (MODIFIED) AS MANUFACTURED IN DENVER, PA PERFUME DALIN PH 0/214082 AS MANUFACTURED IN HOLZMINDEN, GERMANY GRISEOFULVIN AS MANUFACTURED IN SHANGHAI, CHINA ADENOSINE AS MANUFACTURED IN ST.LOUIS, MO HYALURONIC ACID DRUG SUBSTANCE (EXHALE) (ETX100) AS MANUFACTURED IN SHAWNEE MISSION, KS RD1161M,FDA RED TINT COLOR CONCENTRATE FOR PLASTICS AS MANUFACTURED IN AVILLA, IN RD1430P, FDA RED TINT COLOR CONCENTRATE FOR PLASTICS AS MANUFACTURED IN AVILLA, IN BL1473P, FDA BLUE TINT COLOR CONCENTRATE FOR PLASTICS AS MANUFACTURED IN AVILLA, IN Page 468

4Q2012EXCEL DMF# 15905 I 15906 15907 15908 15909 15910 15911 15912 15913 15914 A 15915 C 15916 15917 A 15918 15919 A 15920 A 15921 A 15922 15923 A 15924 15925 A 15926 15927 15928 I 15929 15930 I 15931 A 15932 15933 15934 15935 A A I A II II II II 4/10/2002 3/18/2002 4/11/2002 4/15/2002 ERREGIERRE SPA IVAX CR QUIMICA SINTETICA SA BAXTER PHARMACEUTICALS SOLUTIONS LLC RALOXIFENE HYDROCHLORIDE AS MANUFACTURED IN BERGAMO, ITALY. CABERGOLINE AS MANUFACTURED IN OPAVA-KOMAROV, CZECH REPUBLIC FOSINOPRIL SODIUM AS MANUFACTURED IN MADRID, SPAIN. II 3/26/2002 LUPIN LTD A II III 4/8/2002 4/3/2002 GEDEON RICHTER PLC CLARIANT AUSTRALIA PTY LTD A I II III IV 4/5/2002 4/4/2002 4/5/2002 C II II 4/4/2002 4/4/2002 TEVA GROUP BAXTER PHARMACEUTICALS SOLUTIONS LLC ARCH PHARMALABS LTD DSM RESEARCH LIPOID GMBH I II II 4/3/2002 4/2/2002 LEK PHARMACEUTICALS DD SIEGFRIED LTD III 2/22/2002 BORMIOLI ROCCO SPA BU PLASTICS IV 4/2/2002 FMC CORP FMC BIOPOLYMER DIV A II II 3/29/2002 3/28/2002 FLAMMA SPA BASF PHARMA EVIONNAZ SA MINOXIDIL AS MANUFACTURED IN BERGAMO, ITALY A IV IV 3/29/2002 3/29/2002 DMV FONTERRA EXCIPIENTS GMBH CO KG DMV FONTERRA EXCIPIENTS GMBH CO KG II 3/28/2002 TEVA PHARMACEUTICALS INDUSTRIES LTD I I I A A A A A II II II IV IV V II II II 3/19/2002 3/20/2002 3/20/2002 12/21/2001 2/28/2002 3/22/2002 3/25/2002 3/20/2002 3/27/2002 DAIICHI SANKYO CO LTD SAFC INC DAIICHI SANKYO CO LTD DMV FONTERRA EXCIPIENTS GMBH CO KG UNGERER AND CO SANDOZ GMBH PHARMACIA AND UPJOHN SUB PFIZER INC QUIMICA SINTETICA SA CATALENT UK SWINDON ZYDIS LTD STATUS Type SUBMIT DATE III 3/11/2002 HOLDER COLOR MASTER INC SUBJECT

4Q2012

BL1175M, FDA BLUE TINT COLOR CONCENTRATE FOR PLASTICS AS MANUFACTURED IN AVILLA, IN CS-758 DRUG PRODUCT AS MANUFACTURED IN TOKYO, JAPAN 3-(3-AMINO)-PHTHALAMIDO-GLUTARIMIDE (APG) AS MANUFACTURED IN MADISON, WI CS-758 DRUG SUBSTANCE AS MANUFACTURED IN JAPAN INHALATION LACTOSE AS MANUFACTURED IN THE NETHERLANDS ARTIFICIAL STRAWBERRY FLVP FH-6758 AS MANUFACTURED IN LINCOLN PARK, NJ BIOTECH PRODUCTION BUILDING 211 AS MANUFACTURED IN KUNDL, AUSTRIA METHYLPREDNISOLONE 100MG TABLETS AS MANUFACTURED IN PUURS, BELGIUM CIPROFLOXACIN AS MANUFACTURED IN MADRID, SPAIN SELEGILINE HYDROCHLORIDE ZYDIS TABLET 1.25MG AS MANUFACTURED IN WILTSHIRE, UNITED KINGDOM SYNTHETIC CONJUGATED ESTROGENS, A(F00375) AS MANUFACTURED IN CHICAGO, IL RESPITOSE SV 001 (DPI QUALITY) AS MANUFACTURED IN VEGHEL, THE NETHERLANDS PHARMATOSE 200 M (DPI QUALITY) AS MANUFACTURED IN VEGHEL, THE NETHERLANDS

ARTICAINE HYDROCHLORIDE AS MANUFACTURED IN ST-VULBAS, FRANCE AND EVIONNAZ, SWITZERLAND LUSTRECLEAR(TM) LC 103 MICROCRYSTALLINE CELLULOSE/CARRAGEENAN-BASED COATING AS MANUFACTURED IN NEWARK, DE SPOON 2.5-5 ML + CE MARK AS MANUFACTURED IN CASTELGUELFO(PR), RIVANAZZANO(PV), ITALY AND SAINT SULPICE, FRANCE PRAVASTATIN SODIUM AS MANUFACTURED IN LJUBLJANA, SLOVENIA O-DESMETHYLVENLAFAXINE SUCCINATE MONOHYDRATE AS MANUFACTURED IN ZOFINGEN, SWITZERLAND LAMOTRIGINE AS MANUFACTURED IN BE'ER SHEVA AND PETAH TIQVA, ISRAEL STERILE WATER FOR INJECTION FOR RECONSTITUTION AS MANUFACTURED IN BLOOMINGTON, IN MELOXICAM AS MANUFACTURED IN MAHARASHTRA, INDIA STAMYLAN P PHC 27 AS MANUFACTURED IN AP GELEEN, THE NETHERLANDS LIPOID E PG(EGG PHOSPHATIDYL GLYCEROL) AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY. BUTOCONAZOLE NITRATE AS MANUFACTURED IN BUDAPEST, HUNGARY. CUSTOM COLOR/ADDITIVE CONCENTRATES FOR USE IN PLASTIC PRODUCTS AND PACKAGING IN VICTORIA AND NSW, AUSTRALIA. CEFTRIAXONE SODIUM USP (STERILE ) AS MANUFACTURED IN MADHYA PRADESH, INDIA

BACTERIOSTATIC WATER FOR INJECTION, USP AS MANUFACTURED IN BLOOMINGTON, INDIANA.

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4Q2012EXCEL DMF# 15936 15937 A 15938 15939 15940 A 15941 I 15942 15943 I 15944 15945 I 15946 15947 A 15948 I 15949 15950 A 15951 15952 15953 15954 I 15955 15956 C 15957 15958 15959 A 15960 15961 15962 15963 15964 I 15965 15966 A A II II 5/7/2002 4/29/2002 SAFC BIOSCIENCES INC SYN TECH CHEM AND PHARM CO LTD I I A I II II II II II 4/26/2002 4/30/2002 5/1/2002 4/30/2002 5/3/2002 RECORDATI ESPANA SL XIAN HIGH TECH INDUSTRIES CO LTD TEVA PARENTERAL MEDICINES INC ACE JAPAN CO LTD EXEKIA THE AMERICAS KETOCONAZOLE AS MANUFACTURED IN BENIEL, SPAIN. PACLITAXEL AS MANUFACTURED IN XIAN, CHINA. STERILE WATER FOR INJECTION USP AS MANUFACTURED IN IRVINE, CA. PINDOLOL AS MANUFACTURED IN YAMAGATA, JAPAN. I C IV II II 4/29/2002 4/29/2002 4/28/2002 BIOCODE INC TEVA PHARMACEUTICAL INDUSTRIES LTD PROPRIETARY TRACERS AS MANUFACTURED IN BETHLEHEM, PA. ZOLPIDEM TARTRATE AS MANUFACTURED IN DEBRECEN, HUNGARY. I III II 4/5/2002 4/25/2002 SOLVIN SA A I I IV II II III 4/26/2002 4/26/2002 4/26/2002 4/3/2002 A II II 4/8/2002 4/23/2002 SCINOPHARM TAIWAN LTD KUNSHAN DOUBLE CRANE PHARMACEUTICAL CO LTD SOLVAY FLUOR UND DERIVATE GMBH JOHNSON MATTHEY INC JOHNSON MATTHEY INC NYPRO INC II 4/4/2002 A II II 4/22/2002 4/22/2002 A II II 4/17/2002 4/18/2002 LIPOID GMBH LABORATORIO CHIMICO INTERNAZIONALE SPA MITSUBISHI TANABE PHARMA CORP LEK PHARMACEUTICAL AND CHEMICAL CO DD BOC MICRO APPLICATIONS CENTRE A III II 4/5/2002 4/10/2002 POLYONE CORP CUNO EUROPE SA III 3/11/2002 BASF AKTIENGESELLSCHAFT A I II II II 4/18/2002 4/18/2002 4/17/2002 STREM CHEMICALS INC ASUBIO PHARMA CO LTD CODY LABORATORIES INC STATUS Type SUBMIT DATE A III II 4/9/2002 4/16/2002 HOLDER DAK AMERICAS LLC LIPOID GMBH SUBJECT B 95 A AS MANUFACTURED IN FAYETTEVILLE, NC.

4Q2012

LIPOID PURIFIED SOYBEAN OIL PH. EUR. AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY. CARBOPLATIN (USP) AS MANUFACTURED IN NEWBURYPORT, MA. SUN N 8075 DRUG SUBSTANCE AS MANUFACTURED IN SAITAMA, JAPAN. PHENTERMINE HYDROCHLORIDE ACTIVE INGREDIENT AS MANUFACTURED IN CODY, WY. ULTRAFORM N2320 003 UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY AND THEODORE, AL. CC00012334DR AS MANUFACTURED IN VONORE, TN. ZETACARBON RX5S, SP AND SLP SERIES AS MANUFACTURED IN MAZERES SUR SALAT, FRANCE. LIPOID S VPC-3 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY. ALLOPURINOL AS MANUFACTURED IN MILAN, ITALY. MCI-196 DRUG SUBSTANCE AS MANUFACTURED IN FUKUOKA-KEN, JAPAN. OMEPRAZOLE ACTIVE DRUG SUBSTANCE AS MANUFACTURED IN LJUBLJANA, SLOVENIA. MICRO-CYLINDER PRESSURISED GAS CAPSULE AS MANUFACTURED IN LONDON, UNITED KINGDOM. OMEPRAZOLE AS MANUFACTURED IN TAIWAN, R.O.C. SULFAMETHOXAZOLE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA. NORFLURANE AS MANUFACTURED IN FRANKFURT, GERMANY. RAC-AMPHETAMINE ADIPATE AS MANUFACTURED IN WEST DEPTFORD, NJ. D-AMPHETAMINE ADIPATE AS MANUFACTURED IN WEST DEPTFORD, NJ. METERED DOSE INHALER (MDI) AND SALAMOL EASI-BREATHE (R) CFC FREE AS MANUFACTURED IN CLINTON, MA AND COUNTY DUBLIN, IRELAND. DIOFAN A236 AS MANUFACTURED IN TAVAUX CEDEX, FRANCE.

ZHEJIANG HISUN PHARMACEUTICAL CO LTD VINORELBINE TARTRATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

ZHEJIANG HISUN PHARMACEUTICAL CO LTD CYTARABINE USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

CERAMIC ULTRA-FILTRATION AND MICRO-FILTRATION MEMBRANES AS MANUFACTURED IN BAZET, FRANCE. EX-CELL (TM) VPRO AS MANUFACTURED IN DENVER, PA. METOPROLOL SUCCINATE USP AS MANUFACTURED IN HSIN YING, TAIWAN.

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4Q2012EXCEL DMF# 15967 A 15968 I 15969 A 15970 I 15971 A 15972 15973 15974 A 15975 15976 A 15977 15978 15979 I 15980 15981 15982 I 15983 15984 I 15985 15986 15987 I 15988 15989 15990 15991 A 15992 I 15993 I 15994 15995 I A II II 6/5/2002 5/18/2002 FAKO ILACLARI A S BUYUKDERE SUN PHARMACEUTICAL INDUSTRIES LTD III 5/30/2002 3M ENGINEERED ADHESIVES DIV IV 6/3/2002 CARDINAL HEALTH CANADA 403 INC I N A II II 5/27/2002 5/31/2002 III 5/28/2002 FORMOSA PLASTICS CORP USA NOT AN ASSIGNED NUMBER SCINOPHARM TAIWAN LTD DAIICHI SANKYO EUROPE GMBH A A II II III 5/28/2002 5/24/2002 5/22/2002 C II II 5/24/2002 5/23/2002 PISGAH LABS INC PUNJAB CHEMICALS AND CROP PROTECTION LTD (PHARMA DIV - ALPHA DRUG) TEVA PHARMACEUTICAL INDUSTRIES LTD CHATTEM CHEMICALS INC CCC PLASTICS ETOMIDATE AS MANUFACTURED IN PISGAH FOREST, NC. TRIMETHOPRIM AS MANUFACTURED IN PUNJAB, INDIA. I A II II II 5/13/2002 4/30/2002 5/20/2002 I I II II II 5/13/2002 5/13/2002 5/10/2002 WOCKHARDT LTD SKYEPHARMA PRODUCTION SAS A III II 5/7/2002 5/10/2002 QENOS PTY LTD ACS DOBFAR SPA GF7660 HDPE AS MANUFACTURED IN VICTORIA, AUSTRALIA. A I II II II 5/2/2002 5/10/2002 5/10/2002 TEVA PHARMACEUTICAL INDUSTRIES LTD CHANGZHOU SPL CO AVANTOR PERFORMANCE MATERIALS INC II 5/6/2002 ASH STEVENS INC III 4/26/2002 II 5/6/2002 III 5/2/2002 BERRY PLASTICS CORP TAPES AND COATINGS DIV BORREGAARD AS, BORREGAARD SYNTHESIS CLARIANT AUSTRALIA PTY LTD STATUS Type SUBMIT DATE III 4/16/2002 HOLDER FPC FLEXIBLE PACKAGING CORP SUBJECT

4Q2012

PAPER/POLYESTER/FOIL/POLYETHYLENE POUCH AS MANUFACTURED IN ONTARIO, CANADA. 65 GA PVDC COATED POLYPROPYLENE/1.0# ADHESIVE/1.25 MIL EAA COEX AS MANUFACTURED IN COLUMBUS, GA. REDUCED ALKYLATED IMIDAZOLE AS MANUFACTURED IN SARPSBORG, NORWAY CUSTOM COLOR/ADDITIVE CONCENTRATES FOR USE IN PLASTIC PRODUCTS AND PACKAGING AS MANUFACTURED IN VICTORIA AND NSW, AUSTRALIA. ANAGRELIDE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN RIVERVIEW, MI. AZITHROMYCIN DIHYDRATE AS MANUFACTURED IN PRIGORJE BRDOVECKO, CROATIA. HEPARIN SODIUM USP AS MANUFACTURED IN JIANGSU PROVINCE, CHINA SODIUM PHOSPHATE DIBASIC USP (ESUB) AS MANUFACTURED IN PHILLIPSBURG, NJ.

PENICILLIN G POTASSIUM FOR INJECTION, USP (STERILE BULK) AS MANUFACTURED IN MILANO, ITALY. FEXOFENADINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA. NK-104 TABLETS, 4 AND 8 MG AS MANUFACTURED IN LYON, FRANCE.

UNION QUIMICO FARMACEUTICA SA UQUIFA FLUOROSULFONYLETHANONE AS MANUFACTUED IN BARCELONA, SPAIN. SA PHLOX PHARMACEUTICALS LTD CEFUROXIME AXETIL, USP (AMORPHOUS) AS MANUFACTURED IN GUJARA, INDIA. SAFC INC DAIWA CHEMICAL CO LTD CALCITRIOL, EP AS MANUFACTURED IN MADISON, WI 5-ASA CRUDE (5-AMINOSALICYLIC ACID CRUDE) AS MANUFACTURED IN OSAKA, JAPAN.

AZITHROMYCIN N AS MANUFACTURED IN ZAGREB, CROATIA. BUTALBITAL, USP AS MANUFACTURED IN CHATTANOOGA, TENNESSEE. PURPLE VIOLET MB 50-5021 POLYPROPYLENE COLOUR CONCENTRATE AS MANUFACTURED IN ONTARIO, CANADA. FORMOLENE POLYPROPYLENE AS MANUFACTURED IN POINT COMFORT, TX. ONDANSETRON HYDROCHLORIDE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN. CS-866-HYDROCHLOROTHIAZIDE TABLETS (CS-866HCTZ) AS MANUFACTURED IN PFAFFENHOFEN, GERMANY. VEGICAPS TWO PIECE EMPTY HARDSHELL CELLULOSE CAPSULE AS MANUFACTURED IN SPRINGVILLE, UT. 3M(TM) DOUBLE COATED ADHESIVE TAPE 9596 AS MANUFACTURED IN ABERDEEN, SD AND NEVADA, MO. RANITIDINE HYDROCHLORIDE FORM II AS MANUFACTURED IN ISTANBUL, TURKEY. METOPROLOL TARTRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA.

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4Q2012EXCEL DMF# 15996 15997 A 15998 15999 16000 16001 16002 16003 16004 I 16005 A 16006 16007 16008 16009 A 16010 16011 A 16012 16013 16014 16015 16016 I 16017 16018 16019 16020 16021 16022 16023 16024 A 16025 16026 A 16027 16028 16029 I I A II III II 6/21/2002 5/29/2002 6/20/2002 CADILA PHARMACEUICALS LTD DUPONT POLYESTER TECHNOLOGIES DIPHARMA FRANCIS SRL I II III 5/28/2002 6/21/2002 CADILA PHARMACEUTICALS TEKNOR COLOR CO A I A A A A A II III II II II II II II 6/21/2002 6/14/2002 6/21/2002 6/21/2002 6/21/2002 6/21/2002 6/20/2002 6/24/2002 EDMOND PHARMA SRL LITOFAN SA AMRI RENSSELAER INC AMRI RENSSELAER INC AMRI RENSSELAER INC AMRI RENSSELAER INC DR REDDYS LABORATORIES LTD CIPLA LTD A I I I II II II III III 6/17/2002 6/20/2002 6/20/2002 6/12/2002 5/22/2002 A II II 6/11/2002 6/14/2002 DR REDDYS LABORATORIES LTD JIANGSU HANSOH PHARMACEUTICAL CO LTD DSM FINE CHEMICALS NETHERLANDS BV MITSUBISHI PHARMA CORP ANGELINI ACRAF SPA MAC CLOSURES INC CCC PLASTICS A A A II II II II 6/13/2002 6/11/2002 6/11/2002 6/11/2002 II 6/13/2002 SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE INDUSTRIALE CHIMICA SRL NEULAND LABORATORIES LTD HETERO DRUGS LTD DR REDDYS LABORATORIES LTD A A A I A I II III II II II IV V 6/3/2002 6/5/2002 6/10/2002 6/10/2002 6/6/2002 1/14/2002 2/7/2002 ASKA PHARMACEUTICAL CO LTD 3M DRUG DELIVERY SYSTEMS HIKMA PHARMACEUTICALS XIAN LIBANG PHARMACEUTICAL CO LTD SUN PHARMACEUTICAL INDUSTRIES LTD GRAIN PROCESSING CORP GRAIN PROCESSING CORP STATUS Type SUBMIT DATE A II III 5/20/2002 6/3/2002 HOLDER LUPIN LTD BISCHOF AND KLEIN GMBH AND CO SUBJECT CEFIXIME USP AS MANUFACTURED IN MADHYA PRADESH, INDIA.

4Q2012

PACKAGING FOR PHARMACEUTICAL PRODUCTS AS MANUFACTURED IN LENGERICH, FEDERAL REPUBLIC OF GERMANY. TZT-1027 DRUG SUBSTANCE AS MANUFACTURED IN KANAGAWA, JAPAN. COATED ALUMINIUM CANISTERS AS MANUFACTURED IN LANCASHIRE, GREAT BRITAIN. PREDNISONE ANHYDROUS USP AS MANUFACTURED IN AMMAN, JORDAN. METOLAZONE USP AS MANUFACTURED IN SHANXI PROVINCE, CHINA. TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA. POLYALDITOL AS MANUFACTURED IN MUSCATINE, IOWA. TOXICOLOGICAL STUDIES ON DRY POLYALDITOL PRODUCTS MANUFACTURED IN MUSCATINE, IOWA. CLAVULANATE POTASSIUM STERILE BULK AS MANUFACTURED IN WEST SUSSEX, UNITED KINGDOM. MIDODRINE HYDROCHLORIDE AS MANUFACTURED IN SARONNO, ITALY. MIRTAZAPINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. FOSINOPRIL SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA. SERTRALINE HYDROCHLORIDE (FORM II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. FINASTERIDE USP (FORM III) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. VINORELBINE TARTRATE USP AS MANUFACTURED IN JIANG SU, CHINA. CAFOX AS MANUFACTURED IN VENLO, THE NETHERLANDS. MKC-231 DRUG SUBSTANCE AS MANUFACTURED IN IBARAKI-KEN, JAPAN. MIRTAZAPINE AS MANUFACTURED IN APRILIA, ITALY. FLIP TOP CHILD RESISTANT COMPACT AS MANUFACUTRED IN QUEBEC, CANADA. BLUE AQUA MB 20-6731 POLYETHYLENE COLOUR CONCENTRATE AS MANUFACTURED IN ONTARIO, CANADA. MIDODRINE HYDROCHLORIDE AS MANUFACTURED IN PADERNO DUGNANO, ITALY. PACKAGING MATERIAL AS MANUFACTURED IN BARCELONA, SPAIN. AMPHETAMINE SULFATE USP AS MANUFACTURED IN RENSSELAER, NY. AMPHETAMINE ASPARTATE AS MANUFACTURED IN RENSSELAER, NY. DEXTROAMPHETAMINE SULFATE USP AS MANUFACTURED IN RENSSELAER, NY. DEXTROAMPHETAMINE SACCHARATE AS MANUFACTURED IN RENSSELAER, NY. RISPERIDONE EP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ANAGRELIDE HYDROCHLORIDE MONOHYDRATE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA. LORATIDINE AS MANUFACTURED IN GUJARAT, INDIA. PACKAGING MATERIAL AS MANUFACTURED IN CUMBERLAND, RI; HENDERSON, KY; JACKSONVILLE, TX; LODI, OH; FOUNTAIN INN, SC AND INDUSTRY, CA. LORATIDINE SPECIAL AS MANUFACTURED IN GUJARA, INDIA. MELINAR(R) LASER+ AS MANUFACTURED IN REDCAR, UNITED KINGDOM. FEXOFENADINE HYDROCHLORIDE AS MANUFACTURED IN MARSA, MALTA.

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4Q2012EXCEL DMF# 16030 I 16031 16032 16033 I 16034 16035 16036 A 16037 16038 16039 16040 16041 16042 16043 16044 16045 16046 16047 16048 16049 16050 I 16051 16052 16053 A 16054 16055 16056 16057 16058 16059 16060 16061 A 16062 16063 A 16064 16065 I I IV II 7/25/2002 7/25/2002 A III II 7/25/2002 7/19/2002 PLASTIAPE SPA HELSINN CHEMICALS SA HELSINN ADVANCED SYNTHESIS SA DAVID MICHAEL AND CO INC PCAS I C A A A A A III II II II II II II II 7/15/2002 7/19/2002 7/22/2002 7/18/2002 6/28/2002 7/15/2002 7/24/2002 7/22/2002 TOKYO KOBUNSHI CO LTD TRIFARMA SPA PANION AND BF BIOTECH INC PHARMACIA AND UPJOHN SUB PFIZER INC KREATIVE ORGANICS P LTD DAINIPPON SUMITOMO PHARMA CO LTD HIKAL LTD WOCKHARDT LTD I A IV II II 7/8/2002 7/15/2002 6/27/2002 DAVID MICHAEL AND CO INC EUTICALS SPA CHEMWERTH INC A A I A A A I A A A A A A IV II II III III III II II II III II II II II 7/3/2002 6/27/2002 7/3/2002 7/1/2002 7/2/2002 7/2/2002 7/8/2002 7/8/2002 7/11/2002 7/10/2002 7/11/2002 7/12/2002 7/12/2002 7/9/2002 SPI PHARMA INC FORMOSA LABORATORIES INC ALDRICH CHEMICAL CO INC POLYONE CORP POLYONE CORP POLYONE CORP RANBAXY LABORATORIES LTD MOEHS IBERICA SL ARCH PHARMALABS LTD GERRESHEIMER REGENSBURG GMBH UQUIFA MEXICO SA DE CV BIOCON LTD BIOCON LTD MALLINCKRODT INC I A II II II 6/27/2002 6/26/2002 6/20/2002 ELAN DRUG DELIVERY INC PROCOS SPA ACS DOBFAR SPA OCINAPLON TABLETS AS MANUFACTURED IN COUNTY WESTMEAH, IRELAND. PYRIDOSTIGMINE BROMIDE AS MANUFACTURED IN CAMERI, ITALY. I I II II II 6/26/2002 6/25/2002 6/28/2002 RANBAXY LABORATORIES LTD BIOSEPRA SA GILEAD SCIENCES INC STATUS Type SUBMIT DATE II 6/24/2002 HOLDER PHARMACOSMOS A/S SUBJECT

4Q2012

IRON(III)-HYDROXIDE OLIGOSACCHARIDE COMPLEX AS MANUFACTURED IN VIBY SJ., DENMARK. PRAVASTATIN SODIUM AS MANUFACTURED IN HIMACHAL PRADESH, INDIA. DEAE SPHERODEX LS VV AS MANUFACTURED IN CERGY SAINT CHRISTOPHE, FRANCE. LIPOSOMAL OSI-7904 FOR INJECTION (OSI-7904L) AS MANUFACTURED IN SAN DIMAS, CA.

7-ADCA (7-AMINO-3-DESACETOXY CEPHALOSPORANIC ACID) AS MANUFACTURED IN MILAN, ITALY. PHARMABURST(TM) B SERIES PRODUCTS AS MANUFACTURED IN GRAND HAVEN, MI LEFLUNOMIDE AS MANUFACTURED IN TAOYUAN, TAIWAN. 3-AMINO-1-PROPANESULFONIC ACID AS MANUFACTURED IN SHEBOYGAN FALLS, WI. COLORANTS PRODUCT NO. CC00021366WE AS MANUFACTURED IN FLORENCE, KY. UV ABSORBER PRODUCT NO. CC00012617WE AS MANUFACTURED IN GLENDALE, AZ. UV ABSORBER PRODUCT NO. CC00012601WE AS MANUFACTURED IN GLENDALE, AZ. GANCICLOVIR AS MANUFACTURED IN MADHYA PRADESH, INDIA. CARVEDILOL AS MANUFACTURED IN RUBI, SPAIN. CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN MAHARASHTRA, INDIA. TURBUHALER AS MANUFACTURED IN PFREIMD, FEDERAL REPUBLIC OF GERMANY. METFORMIN HYDROCHLORIDE AS MANUFACTURED IN MORELOS, MEXICO. PRAVASTATIN SODIUM AS MANUFACTURED IN BANGALORE, INDIA. COMPACTIN AS MANUFACTURED IN BANGALORE, INDIA. POTASSIUM IODIDE USP GRANULAR FOOD GRADE, CODE 1112 AND POTASSIUM IODIDE BP IODURE DE POTASSIUM, CODE 1220 AS MANUFACUTRED IN ST.LOUIS, MO. ARTIFICIAL GRAPE FLAVOR #21126 AS MANUFACTURED IN PHILADELPHIA, PA. PANCURONIUM BROMIDE AS MANUFACTURED IN ROZZANO, ITALY. ESMOLOL HCL AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA FOR CHEMWERTH INC SILICONE COATING PROCESS AS MANUFACTURED IN SAITAMA PREFECTURE, JAPAN. PROCHLORPERAZINE EDISYLATE USP AS MANUFACTURED IN MILANO, ITALY. FERRIC CITRATE AS MANUFACTURED IN VANCOUVER, CANADA. IDARUBICIN HYDROCHLORIDE AS MANUFACTURED IN CORK, IRELAND. BISACODYL USP AS MANUFACTURED IN HYDERABAD, INDIA. SM-13496 AS MANUFACTURED IN TSURUSAKI OITA, JAPAN GABAPENTIN AS MANUFACTURED IN BANGALORE, INDIA. OXYBUTYNIN CHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA STATE, INDIA. MONODOSE INHALER MODEL 5 AS MANUFACTURED IN LECCO, ITALY. PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN BIASCA, SWITZERLAND. NATURAL PEPPERMINT FLAVOR #15318 AS MANUFACTURED IN PHILADELPHIA, PA. FENOFIBRATE AS MANUFACTURED IN LIMAY, FRANCE.

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4Q2012EXCEL DMF# 16066 16067 16068 16069 16070 A 16071 16072 16073 16074 16075 16076 A 16077 16078 16079 A 16080 A 16081 16082 16083 16084 16085 A 16086 16087 I 16088 I 16089 16090 16091 16092 I 16093 A 16094 16095 16096 16097 I 16098 I II 8/19/2002 RANBAXY LABORATORIES LTD A I I II II V II 8/12/2002 8/12/2002 8/5/2002 8/12/2002 BIOCON LTD BIOCON INDIA LTD PATHEON UK LTD SWINDON OPERATIONS FINE CHEMICALS CORP PTY LTD II 8/9/2002 LIPOID GMBH A A A II II IV II 8/6/2002 8/7/2002 8/6/2002 8/12/2002 HIKMA PHARMACEUTICALS DR REDDYS LABORATORIES LTD WILD FLAVORS INC ELAN DRUG DELIVERY INC IV 8/7/2002 FONA INTERNATIONAL INC I II IV 8/9/2002 8/6/2002 PHARMACIA AND UPJOHN WILD FLAVORS INC I A A A III II II II II 7/29/2002 8/6/2002 8/6/2002 8/5/2002 8/2/2002 CONSOLIDATED BOTTLE SANDOZ GMBH SANDOZ INDUSTRIAL PRODUCTS SA MEDICHEM SA SAFC INC II 8/1/2002 A I II III II 7/31/2002 7/18/2002 7/30/2002 KUREHA CORP MAC CLOSURES INC NIPPON SYNTHETIC CHEMICAL INDUSTRY CO LTD AVANTI POLAR LIPIDS INC I A A A I II II II III II II 7/30/2002 7/22/2002 7/29/2002 7/17/2002 7/25/2002 7/31/2002 STATUS Type SUBMIT DATE I A A A IV IV IV IV II 7/10/2002 7/22/2002 7/22/2002 7/22/2002 7/24/2002 HOLDER DMV INTERNATIONAL GMBH UNGERER AND CO UNGERER AND CO UNGERER AND CO PRIME EUROPEAN THERAPEUTICS SPA EUTICALS SPA MITSUBISHI TANABE PHARMA CORP SCINOPHARM TAIWAN LTD AVECIA BIOTECHNOLOGY INC EI DUPONT DENEMOURS AND CO INC CADILA PHARMACEUTICALS LTD GLAXOSMITHKLINE LLC SUBJECT RESPITOSE AN001 AS MANUFACTURED IN VEGHEL, THE NETHERLANDS.

4Q2012

ARTIFICIAL MASKING AGENT FL FL-5576 AS MANUFACTURED IN BETHLEHEM, PA. N/A TROPICAL PUNCH BASE 40709 AS MANUFACTURED IN BETHLEHEM, PA. N/A TROPICAL PUNCH FL FL-6182 AS MANUFACTURED IN BETHLEHEM, PA. B-WING AS MANUFACTURED IN ORIGGIO, ITALY. MCC-257 AS MANUFACTURED IN IBARAKI-KEN, JAPAN. BENAZEPRIL HYDROCHLORIDE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN. OLIGONUCLEOTIDE ANV AS MANUFACTURED IN MILFORD, MA. TOPCOAT 3200-100 AS MANUFACTURED IN MECHELEN, BELGIUM. CHLORHEXIDINE BASE AS MANUFACTURED IN GUJARA, INDIA. TICARCILLIN DISODIUM BULK (STERILE ) AS MANUFACTURED IN WEST SUSSEX, UNITED KINGDOM. KREMEZIN DRUG SUBSTANCE AS MANUFACTURED IN FUKUSHIMA, JAPAN. NASAL PLUG AND SPRAY CAP AS MANUFACTURED IN QUEBEC, CANADA. HMN-214 AS MANUFACTURED IN KUMAMOTO, JAPAN. 1,2-DIPALMITOYL-SN-GLYCERO-3[PHOSPHO-RAC-(1-GLYCEROL)] (SODIUM SALT/EDTA) AS MANUFACTURED IN ALABASTER, AL. CAP & PLUG ASSEMBLY AS MANUFACTURED IN STOCKHEIM, GERMANY. CEFTAZIDIME FOR INJECTION AS MANUFACTURED IN TYROL, AUSTRIA. CLARITHROMYCIN (NON-STERILE BULK) AS MANUFACTURED IN BARCELONA, SPAIN. VENLAFAXINE HCL AS MANUFACTURED IN GIRONA, SPAIN. 2-METHYLENE-19-NOR-20-EPI-1 ,25-DIHYDROXYVITAMIN D3 AS MANUFACTURED IN MADISON, WI. DIHYDROFLUOCINOLONE ACETONIDE AS MANUFACTURED IN KALAMAZOO, MI. NATURAL PEPPERMINT FLAVOR WONF #FATEL649 AS MANUFACTURED IN ERLANGER, KY. #877.242 N-C MINT ROOTBEER FLAVOR, NATURAL AND ARTIFICIAL AS MANUFACTURED IN CAROL STREAM, IL. HYDROCORTISONE USP AS MANUFACTURED IN AMMAN, JORDAN. CLOPIDOGREL BISULFATE FORM I AS MANUFACTURED IN ANDHRA PRADESH, INDIA. NATURAL ORANGE FLAVOR #FATEB893 AS MANUFACTURED IN ERLANGER, KY. N1177 NANOCRYSTAL(R) COLLOIDAL DISPERSION AS MANUFACUTRED IN HORSHAM, PA. LIPOID FA 16:0 AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY. SIMVASTATIN USP AS MANUFACTURED IN BANGALORE, INDIA. LOVASTATIN TECHNICAL(SFP) AS MANUFACTURED IN BANGALORE, INDIA. STERILE MANUFACTURING AT SWINDON, UNITED KINGDOM. FLUPHENAZINE DECANOATE OIL(BMS) AS MANUFACTURED IN CAPE TOWN, SOUTH AFRICA. ATORVASTATIN CALCIUM(AMORPHOUS) AS MANUFACTURED IN PUNJAB, INDIA.

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4Q2012EXCEL DMF# 16099 16100 16101 A 16102 16103 16104 16105 I 16106 I 16107 A 16108 A 16109 16110 16111 A 16112 16113 16114 16115 16116 16117 A 16118 16119 16120 A 16121 I 16122 16123 I 16124 16125 16126 16127 16128 I 16129 A II 9/10/2002 SIGNA SA DE CV A A A A II II IV II III 9/6/2002 9/6/2002 9/6/2002 9/6/2002 9/4/2002 TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD PETER GREVEN NEDERLAND CV BASF PHARMA EVIONNAZ SA AMPACET CORP LEFLUNOMIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. SERTRALINE HYDROCHLORIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. A II II 9/4/2002 9/6/2002 SEVEN STAR PHARMACEUTICAL CO LTD REPLIGEN CORP III 8/23/2002 A A II II II 8/23/2002 8/27/2002 8/30/2002 SCINOPHARM TAIWAN LTD WOCKHARDT LTD PRODUCTOS QUIMICOS NATURALES SA DE CV CLARIANT (CANADA) INC A A I I A II II IV II III III 8/29/2002 8/22/2002 8/26/2002 8/29/2002 8/20/2002 8/19/2002 ALEMBIC PHARMACEUTICALS LTD SUN PHARMACEUTICAL INDUSTRIES LTD HISAMITSU PHARMACEUTICAL CO INC CQ INTERNATIONAL APTAR FRANCE SAS GERRESHEIMER BOLESLAWIEC S A A A II II III 8/23/2002 8/22/2002 8/21/2002 CIPLA LTD POLYPEPTIDE LABS INC AMPACET CORP II 8/21/2002 III 8/15/2002 II 8/21/2002 I A A II IV II II 8/19/2002 8/21/2002 8/16/2002 8/21/2002 MALLINCKRODT INC NATIONAL STARCH CHEMICAL CO NEULAND LABORATORIES LTD HEBEI ZHONGXING PHARMACEUTICAL CO LTD SHIJIAZHUANG PHARM GROUP HEBEI ZHONGRUN PHARMACEUTICAL CO LT DUPONT PERFORMANCE COATING GMBH & CO KG LUPIN LTD STATUS Type SUBMIT DATE A I II III III 8/15/2002 7/10/2002 8/20/2002 HOLDER IRIX MANUFACTURING INC COLORS FOR PLASTICS FORMOSA PLASTICS CORP USA SUBJECT METYROSINE USP AS MANUFACTURED IN GREENVILLE, SC. B19558 AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

4Q2012

FORMOLON PVC RESINS AS MANUFACTURED IN POINT COMFORT, TX AND BATON ROUGE, LA. HYDROCODONE ALKALOID (ESUB) AS MANUFACTURED IN ST.LOUIS, MO. UNIPURE(TM) DW AS MANUFACTURED IN INDIANAPOLIS, IN. ALBUTEROL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. 7-AMINOCEPHALOSPORANIC ACID AS MANUFACTURED IN HEBEI PROVINCE, CHINA. PENICILLIN G POTASSIUM AS MANUFACTURED IN HEBEI PROVINCE, CHINA. HERBERTS-1K-LF 190 X3 AS MANUFACTURED IN WUPPERTAL, GERMANY. CEFUROXIME AXETIL (AMORPHOUS) USP AS MANUFACTURED IN MADHYA PRADESH, INDIA. LEFLUNOMIDE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA. THYMOSIN-ALPHA 1 DRUG SUBSTANCE AS MANUFACTURED IN TORRENCE, CA. 161367 USA INJ.DARK BLUE POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; TERRY HAUTE, IN; CARTERSVILLE, GA; DERIDDER, LA; LATEXO, TX; HEATH, OH AND MESSANCY, BELGIUM. LEFLUNOMIDE AS MANUFACTURED IN GUJARAT, INDIA. MIRTAZAPINE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA. PIROTIODECANE (HPE-101) AS MANUFACTURED IN TOKYO, JAPAN. CAMPTOTHECIN AS MANUFACTURED IN HUBEI, CHINA. APTAR EPDM ELASTOMER AS MANUFACTURED IN VAL-DE REUIL, FRANCE PLASTIC BOTTLES AND ACCESSORIES, DROPPER BOTTLE SYSTEMS AND CONTAINERS WITH CLOSURE SYSTEMS AS MANUFACTURED IN BOLESLAWIEC, POLAND. DANTROLENE SODIUM AS MANUFACTURED IN TAIWAN, R.O.C. BETHANECHOL CHLORIDE USP AS MANUFACTURED IN MAHARASHTRA STATE, INDIA. ESTRADIOL 3 ACETATE AS MANUFACTURED IN IXTACZOQUITLAN, MEXICO AND BERLIN, GERMANY. BLUE CLARIANT MASTERBATCHES 04EHD-7206 AS MANUFACTURED IN ONTARIO AND QUEBEC, CANADA. GUAIFENESIN USP AS MANUFACTURED IN TAIPEI, R.O.C. RG2133(TRIACETYL URIDINE) DRUG SUBSTANCE AS MANUFACTURED IN VARESE, ITALY.

MAGNESIUM STEARATE AS MANUFACTURED IN PG VENLO, THE NETHERLANDS. MEFLOQUINE HYDROCHLORIDE AS MANUFACTURED IN EVIONNAZ, SWITZERLAND. 100497 SLIP POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; TERRE HAUTE, IN; CARTERSVILLE, GA; DERIDDER, LA; LATEXO, TX; HEATH, OH AND MESSANCY, BELGIUM. ALENDRONATE SODIUM TRIHYDRATE AS MANUFACTURED IN TOLUCA, MEXICO.

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4Q2012EXCEL DMF# 16130 A 16131 I 16132 I 16133 A 16134 A 16135 A 16136 A 16137 I 16138 16139 I 16140 16141 16142 16143 16144 16145 A 16146 16147 A 16148 16149 A 16150 A 16151 16152 A 16153 I 16154 A 16155 16156 16157 A I I IV III III 9/27/2002 10/1/2002 9/25/2002 THERMAX LTD.CHEMICAL DIVISION BESPAK PLC GRAHAM PACKAGING COMPANY L.P. TULSION(R) 335 AS MANUFACTURED IN MAHARASHTRA, INDIA. ALBUTEROL ACTUATOR-CAP ASSEMBLY AS MANUFACTURED IN APEX, NC. PLASTIC BOTTLES AS MANUFACTURED CINCINNATI, OH. III 9/24/2002 POLYONE CORP III 9/30/2002 WEST PENN PLASTIC INC A II II 9/25/2002 9/25/2002 TARO PHARMACEUTICAL INDUSTRIES LTD SANOFI CHIMIE II 9/24/2002 LONZA BIOTEC SRO A II IV 9/26/2002 9/25/2002 I III II 9/20/2002 9/5/2002 PLASPAK CLOSURES PTY LTD MALLADI DRUGS AND PHARMACEUTICALS LTD AMRI RENSSELAER INC INTERNATIONAL SPECIALTY PRODUCTS A I A A A II II II II II II 9/19/2002 9/19/2002 9/24/2002 9/23/2002 9/24/2002 9/24/2002 CHEMAGIS LTD AIR PRODUCTS AND CHEMICALS INC JUBILANT LIFE SCIENCES LTD DR REDDYS LABORATORIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD CAMBRIDGE MAJOR LABS INC A IV II 9/23/2002 9/17/2002 ROBERTET FLAVORS INC PROMETIC BIOSCIENCES LTD III 9/13/2002 LORMAC INDUSTRIAL DISTRIBUTORS LTD II 9/16/2002 II 9/16/2002 II 9/13/2002 ORCHID CHEMICALS AND PHARMACEUTICALS LTD ACTAVIS PHARMA MANUFACTURING PRIVATE LTD 3M PHARMACEUTICALS SBC III 9/12/2002 IV 9/12/2002 QUEST INTERNATIONAL FLAVORS FOOD INGREDIENTS CO CCC PLASTICS III 9/3/2002 AMPACET CORP STATUS Type SUBMIT DATE II 9/11/2002 HOLDER NEULAND LABORATORIES LTD SUBJECT

4Q2012

O-BENZYL ALBUTEROL INTERMEDIATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. 11070-K SITE 70 POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; TERRE HAUTE, IN; CARTERSVILLE, GA; DERIDDER, LA; LATEXO, TX; HEATH, OH; MESSANCY, BELGIUM AND RAYONG, THAILAND. FLAVORS AS MANUFACTURED IN OWINGS MILL, MD. WHITE MB20-9098 POLYETHYLENE COLOUR CONCENTRATE AS MANUFACTURED IN ONTARIO, CANADA. CEFAZOLIN SODIUM, USP(STERILE BULK) AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA. MIDODRINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN KANCHIPURAM, INDIA. TESTOSTERONE/ESTRADIOL TRANSDERMAL DELIVERY SYSTEMS CHEMISTRY, MANUFACTURING, AND CONTROLS (CMC) AND TOXICOLOGY LORMAC POLYETHYLENE PRODUCTS AS MANUFACTURED IN CORK, IRELAND AND BRIGHOUSE, UNITED KINGDOM. ARTIFICIAL PINEAPPLE FLAVOR NV-13,012 AS MANUFACTURED IN PISCATAWAY, NJ. P-AMINOBENZAMIDINE AGAROSE 6XL AS MANUFACTURED IN CAMBRIDGE, UNITED KINGDOM. MODAFINIL AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. SURFYNOL(R) SE SURFACTANT AS MANUFACTURED IN CALVERT CITY, KY. LAMOTRIGINE AS MANUFACTURED IN KARNATAKA STATE, INDIA. RALOXIFENE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ACYCLOVIR AS MANUFACTURED IN PETAH TIQVA AND BE'ER SHEVA, ISRAEL. FENOLDOPAM MESYLATE AS MANUFACTURED IN GERMANTOWN, WI FOR SAGE CHEMICALS, INC. 28 MM CLOSURE AS MANUFACTURED IN NSW, AUSTRALIA. D-PSEUDOEPHEDRINE SULFATE AS MANUFACTURED IN TAMILNADU, INDIA. PHENOBARBITAL SODIUM USP AS MANUFACTURED IN RENSSELAER, NY. GANEX WP-660(VP/1-TRIANCONTENE COPOLYMER) AS MANUFACTURED IN CALVERT CITY, KY. L-CARNITINE CRYSTALLINE USP GRADE AS MANUFACTURED IN KOURIM, CZECH REPUBLIC. GABAPENTIN AS MANUFACTURED IN HAIFA BAY, ISRAEL. HYDROXOCOBALAMIN ACETATE PH.EUR.,JP,PYROGEN-FREE AS MANUFACTURED IN ROMAINVILLE CEDEX, FRANCE. INJECTION MOLDING USING THERMOPLASTICS, COLORANTS, AND CHEMICAL ADDITIVES AS MANUFACTURED IN NEW CASTLE, PA. UV ABSORBER PRODUCT NUMBER CC0003827960 AS MANUFACTURED IN GLENDALE, AZ.

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4Q2012EXCEL DMF# 16158 I 16159 16160 16161 16162 16163 A 16164 I 16165 16166 16167 16168 16169 16170 A 16171 A 16172 16173 A 16174 16175 A 16176 A 16177 A 16178 16179 A 16180 16181 16182 16183 16184 16185 16186 16187 16188 16189 16190 A A A A I I I I A A A II III III II II II II II II II IV 10/8/2002 10/8/2002 10/9/2002 10/14/2002 10/11/2002 10/11/2002 10/8/2002 10/4/2002 10/4/2002 10/4/2002 10/15/2002 DR REDDYS LABORATORIES LTD RIWISA AG SEALED AIR CORP PEPTISYNTHA SA MERCK SANTE SAS MERCK SANTE SAS IRVINE SCIENTIFIC SALES CO UQUIFA MEXICO SA DE CV UQUIFA MEXICO SA DE CV UNICHEM LABORATORIES LTD NATIONAL STARCH LLC A II II 10/9/2002 9/18/2002 SYNBIAS PHARMA LTD CHEMISCHE FABRIK BUDENHEIM KG V 9/26/2002 134A CONSORTIUM ACCEPTANCE TESTING OF HFA-134A(1,1,1,2-TETRAFLUOROETHANE) AS MANUFACTURED BY INEOS FLUOR. DOXORUBICIN HYDROCHLORIDE AS MANUFACTURED IN DONETSK, UKRAINE. II 10/4/2002 CHATTEM CHEMICALS INC A II III 9/24/2002 9/27/2002 SUN PHARMACEUTICAL INDUSTRIES LTD TOKAI CHEMICAL INDUSTRY CO LTD A II III 9/30/2002 9/30/2002 INKE SA NIPRO GLASS FRANCE II 10/2/2002 SAFC BIOSCIENCES INC I C N N N II 10/2/2002 V II 9/17/2002 10/1/2002 STERIS ISOMEDIX SERVICES CAMBREX CHARLES CITY INC NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER SAFC BIOSCIENCES INC II 9/30/2002 BECTON DICKINSON AND CO A A A A III III III III III 9/20/2002 9/23/2002 9/23/2002 9/23/2002 9/24/2002 STERI PLAS PTY LTD STERI PLAS PTY LTD STERI PLAS PTY LTD STERI PLAS PTY LTD POLYONE CORP STATUS Type SUBMIT DATE II 9/30/2002 HOLDER BECTON DICKINSON AND CO SUBJECT

4Q2012

BD CELL MAB MEDIUM ANIMAL COMPONENT FREE AS MANUFACTURED IN HERDON, VA AND COCKEYSVILLE, MD. 35ML TABLET BOTTLE AS MANUFACTURED IN NSW, AUSTRALIA. 55ML TABLET BOTTLE AS MANUFACTURED IN NSW, AUSTRALIA. 45ML TABLET BOTTLE AS MANUFACTURED IN NSW, AUSTRALIA. 20ML TABLET BOTTLE AS MANUFACTURED IN NSW, AUSTRALIA. UV ABSORBER PRODUCT NUMBER CC00003928WE AS MANUFACTURED IN GLENDALE, AZ. BD CELL MAB MEDIUM SERUM-FREE AS MANUFACTURED IN HERDON, VA AND COCKEYSVILLE, MD. CONTRACT STERILIZATION FACILITY AS MANUFACTURED IN MINNEAPOLIS, MN. NICOTINE POLACRILEX, 15%, USP AS MANUFACTURED IN CHARLES CITY, IOWA.

EX-CELL(TM) 302 SERUM-FREE MEDIUM, W/O L-GLUTAMINE AS MANUFACTURED IN DENVER, PA. EX-CELL(TM) 620-HSF, HYBRIDOMA SERUM-FREE MEDIUM, W/O L-GLUTAMINE AS MANUFACTURED IN DENVER, PA. ONDANSETRON BASE AS MANUFACTURED IN BARCELONA, SPAIN. PACKAGING MATERIAL AS MANUFACTURED IN AUMALE, AUTHON DU PERCHE AND LUCENAY LES AIX, FRANCE. FLUVOXAMINE MALEATE BP AS MANUFACTURED IN MAHARASHTRA, INDIA. PACKAGING MATERIALS AS MANUFACTURED IN TOYOTA CITY, OBARA VILLAGE AND MOKA CITY, JAPAN. METHAMPHETAMINE HYDROCHLORIDE USP AS MANUFACTURED IN CHATTANOOGA, TN.

DIBASIC SODIUM PHOSPHATE ANHYDROUS AS MANUFACTURED IN BUDENHEIM, GERMANY. SULINDAC USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. DRY POWDER INHALER AS MANUFACTURED IN HAEGGLINGEN, SWITZERLAND. UNIMARK WINGED SPIKE PORT AS MANUFACTURED IN GREER, SC. ATN 161 BULK DRUG SUBSTANCE AS MANUFACTURED IN BRUSSELS, BELGIUM. CRE 15876/A4 INTERMEDIATE AS MANUFACTURED IN CALAIS, FRANCE. CRE 16257 DRUG SUBSTANCE AS MANUFACTURED IN PITHIVIERS, FRANCE. IS CHO-CD(TM) (L) CATALOG #91119 AS MANUFACTURED IN SANTA ANA, CA. TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN MORELOS, MEXICO. VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN MORELOS, MEXICO. MELOXICAM USP (ESUB) AS MANUFACTURED IN RAIGAD, INDIA. UNIPURE(TM) DW-L, PREGELATINIZED CORN STARCH NF, PHEUR AS MANUFACTURED IN INDIANAPOLIS, IN. Page 477

4Q2012EXCEL DMF# 16191 I 16192 16193 16194 I 16195 A 16196 16197 16198 16199 16200 16201 16202 A 16203 16204 16205 A 16206 16207 16208 16209 16210 A 16211 16212 16213 A 16214 16215 16216 16217 16218 16219 16220 16221 16222 16223 16224 16225 A I A A A I A A I I I A III II III II II III III III II II II II 10/25/2002 10/22/2002 10/12/2002 10/21/2002 10/30/2002 10/25/2002 7/22/2002 10/2/2002 10/24/2002 10/24/2002 11/5/2002 11/5/2002 BOREALIS AG ERREGIERRE SPA PIRAMAL GLASS LTD FIDIA FARMACEUTICI SPA WOCKHARDT LTD BOREALIS AG ALBIS PLASTIC GMBH AIR PRODUCTS AND CHEMICALS INC SANKYO CO LTD SANKYO CO LTD CILAG AG SUZHOU NUMBER 4 PHARMACUTICAL FACTORY I A III II IV 9/27/2002 10/17/2002 10/22/2002 I I A I II II II II II 10/15/2002 10/25/2002 10/25/2002 10/24/2002 10/23/2002 I I II II II 10/18/2002 10/22/2002 10/22/2002 BANYU PHARMACEUTICAL CO LTD LEK PHARMACEUTICALS DD A I I I I A III III III III II II III 8/27/2002 10/9/2002 10/9/2002 10/9/2002 10/22/2002 10/14/2002 1/6/2003 BASF SE COLORS FOR PLASTICS COLORS FOR PLASTICS COLORS FOR PLASTICS VERA LABORATORIES LTD SIFAVITOR SRL JAPAN VILENE CO LTD III 10/17/2002 WIPF AG A A II II II 9/26/2002 10/17/2002 10/17/2002 STATUS Type SUBMIT DATE II 9/24/2002 HOLDER YANCHENG SUHAI PHARMACEUTICAL CO LTD LONZA LTD DR REDDYS LABORATORIES INC LEK PHARMACEUTICALS DD SUBJECT DOXYCYCLINE HYCLATE USP AS MANUFACTURED IN JIANGSU, CHINA. SB 200473 AS MANUFACTURED IN VISP, SWITZERLAND. RAMIPRIL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

4Q2012

DIHYDROERGOTAMINE MESYLATE AS MANUFACTRUED IN KOLODVORSKA, SLOVENIA. POLIALUVEL(R) STERIL OVERWRAP BAG INTENDED FOR DRUG PACKAGING AS MANUFACTURED IN VOLKETSWIL, SWITZERLAND. ULTRADUR B 4500 NATURAL AS MANUFACTURED IN SCHWARZHEIDE, GERMANY. E13210 AS MANUFACTURED IN ELK GROVE VILLAGE, IL. E13211 AS MANUFACTURED IN ELK GROVE VILLAGE, IL. S34508 AS MANUFACTURED IN ELK GROVE VILLAGE, IL. NAPROXEN SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA. KETOTIFEN FUMARATE AS MANUFACTURED IN LODI, ITALY. MEDICAL BACKING NON-WOVEN FABRIC: EW-4350PE AS MANUFACTURED IN IBARAKI, JAPAN. J-107088 AS MANUFACTURED IN TOKYO, JAPAN. PRAVASTATIN SODIUM AS MANUFACTURED IN KOLODVORSKA, SLOVENIA.

ZHEJIANG HISUN PHARMACEUTICAL CO LTD CLADRIBINE NON-STERILE ACTIVE BULK DRUG AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. ROHIT PLASTICS AND CHEMICALS CHLORHEXIDINE GLUCONATE 20% AS MANUFACTURED IN MAHARASHTRA, INDIA. VERA LABORATORIES LTD ALEMBIC PHARMACEUTICALS LTD PISGAH LABS INC ZHEJIANG KANGLE PHARMACEUTICAL CO LTD BASF AKTIENGESELLSCHAFT UQUIFA MEXICO SA DE CV FMC CORP FMC BIOPOLYMER DIV TRAZODONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. FENOFIBRATE AS MANUFACTURED IN GUJARAT, INDIA. BUTALBITAL USP AS MANUFACTURED IN PISGAH FOREST, NC. ACETAMINOPHEN AS MANUFACTRUED IN ZHEJIANG PROVINCE, CHINA. RONFALIN SCF 34 WHITE 30265 AS MANUFACTURED IN AP GELEEN, NETHERLANDS. KETOCONAZOLE AS MANUFACTURED IN MORELOS, MEXICO. PROTANAL(R) SODIUM ALGINATE, NF AS MANUFACTURED IN HAUGESUND, VORMEDAL AND DRAMMEN, NORWAY. PACKAGING MATERIAL FB2310 AS MANUFACTURED IN PORVOO, FINLAND. NISOLDIPINE AS MANUFACTURED IN BERGAMO, ITALY. GLASS CONTAINERS AS MANUFACTURED IN GUJARAT, INDIA. OXANDROLONE AS MANUFACTURED IN MULAZZANO, ITALY. CLARITHROMYCIN AS MANUFACTURED IN GUJARAT STATE, INDIA. PACKAGING MATERIAL FB2230 AS MANUFACTURED IN PORVOO, FINLAND. LUPOLEN CONCENTRATE SL 02 EA AS MANUFACTURED IN HAMBURG, GERMANY. FLEXCRYL(R) AC20 EMULSION AS MANUFACTURED IN PIEDMONT, SC. CS-003 DRUG PRODUCT AS MANUFACTURED IN TOKYO AND SHIGA, JAPAN. CS-003 DRUG SUBSTANCE AS MANUFACTURED IN KANAGAWA, JAPAN. DIVALPROEX SODIUM AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND. CLINDAMYCIN PHOSPHATE USP AS MANUFACTURED IN JIANGSU PROVINCE, CHINA.

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4Q2012EXCEL DMF# 16226 16227 16228 16229 16230 16231 A 16232 16233 I 16234 16235 16236 I 16237 I 16238 16239 A 16240 A 16241 16242 16243 16244 16245 16246 16247 16248 16249 16250 16251 A 16252 16253 16254 16255 C 16256 16257 16258 16259 16260 A I A A I II IV II II IV 1/2/2003 11/21/2002 10/31/2002 11/20/2002 1/14/2003 SA AJINOMOTO OMNICHEM NV NATIONAL STARCH CHEMICAL CO SYNBIAS PHARMA LTD SUVEN LIFE SCIENCES LTD OVERSEAL NATURAL INGREDIENTS LTD BALSALAZIDE DISODIUM AS MANUFACTURED IN BALEN, BELGIUM. I A A III II II II 11/14/2002 11/18/2002 11/19/2002 11/15/2002 A A A A A A A I A A II II II II II II II II II II II 11/13/2002 11/13/2002 11/15/2002 11/14/2002 11/15/2002 12/10/2002 11/19/2002 11/18/2002 11/20/2002 11/19/2002 11/14/2002 II 11/11/2002 A II III 11/6/2002 11/11/2002 TRAGARA PHARMACEUTICALS INC RPC FORMATIC GMBH II 11/6/2002 GILEAD SCIENCES INC I A II II II 11/11/2002 11/5/2002 11/7/2002 NV ORGANON YANGZHOU PHARMACEUTICAL CO LTD MITSUBISHI PHARMA CORP I II III 11/8/2002 11/5/2002 CUNO INC ROHM AND HAAS CO STATUS Type SUBMIT DATE A I A I I II II III III III IV 11/4/2002 10/28/2002 10/28/2002 9/25/2002 11/11/2002 11/4/2002 HOLDER TRAGARA PHARMACEUTICALS INC IRVINE SCIENTIFIC SALES CO POLYONE CORP BANGKOK POLYESTER PUBLIC CO LTD GRAHAM PACKAGING COMPANY L.P. FERTIN PHARMA AS SUBJECT CS-706 DRUG SUBSTANCE AS MANUFACTURED IN KANAGAWA, JAPAN. IS MAB-V(TM) AS MANUFACTURED IN SANTA ANA, CA.

4Q2012

COLORANT PRODUCT NO. CC0003821560 AS MANUFACTURED IN SEABROOK, TX. BANGKOK PET V080P AS MANUFACTURED IN BANGKOK, THAILAND. PLASTIC BOTTLES AS MANUFACTURED IN FINDLAY, OH. CHEWING GUM BASE: DAN MED 60 M/BHT (GUMLINK AS ITEM NO.: 25048) AS MANUFACTURED IN VEJLE, DENMARK. PTFE MEMBRANCE CARTRIDGE PRODUCTS AS MANUFACTURED IN MERIDEN, CT. LAMAL 408-40 AND LAMAL COREACTANT C AS MANUFACTURED IN MEXICO AND ELK GROVE VILLAGE, IL. HEPARIN SODIUM III AS MANUFACTURED IN OSS, THE NETHERLANDS. ISONIAZID AS MANUFACTURED IN JIANGSU PROVINCE, CHINA. MT-210 BULK DRUG SUBSTANCE AS MANUFACTURED IN IBARAKI PREFECTURE, JAPAN. LIPOSOMAL LURTOTECAN FOR INJECTION (OSI-211) AS MANUFACTURED IN SAN DIMAS, CA. CS-706 DRUG PRODUCT AS MANUFACTURED IN TOKYO, JAPAN.

M-71 MOUTHPIECE, MATERIAL NO.35155911 AS MANUFACTURED IN MELLRICHSTADT, GERMANY. ZHEJIANG HISUN PHARMACEUTICAL CO LTD VINBLASTINE SULFATE USP, NON-STERILE BULK DRUG AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. SICOR SWISS BRANCH FORMOTEROL FUMARATE AS MANUFACTURED IN VACALLO, SWITZERLAND. INDENA SPA DELMAR CHEMICALS INC CHEMAGIS LTD TEVA PHARMACEUTICAL INDUSTRIES LTD MYLAN LABORATORIES LTD ITF CHEMICAL LTDA PROMETIC BIOSCIENCES LTD SSP CO LTD DIPHARMA FRANCIS SRL PACLITAXEL P.I. AS MANUFACTURED IN SETTALA, ITALY. MONTELUKAST SODIUM THIOL ACID AS MANUFACTURED IN QUEBEC, CANADA. CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN BEER SHEVA, ISRAEL. CLONAZEPAM AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. NAPROXEN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN BAHIA, BRAZIL. MABSORBENT A1P AS MANUFACTURED IN ISLE OF MAN, BRITISH ISLES. SS734 AS MANUFACTURED IN TOYAMA PREFECTURE, JAPAN. MODAFINIL AS MANUFACTURED IN CARONNO PERTUSELLA, ITALY.

UNION QUIMICO FARMACEUTICA SA UQUIFA RANITIDINE BASE AS MANUFACTURED IN BARCELONA, SPAIN. SA ROHM AND HAAS CO ROBOND PS-7619 AS MANUFACTURED IN LOUISVILLE, KY. ROHIT PLASTICS AND CHEMICALS SIEGFRIED LTD CHLORHEXIDINE ACETATE AS MANUFACTURED IN MAHARASHTRA, INDIA. AMOROLFINE HYDROCHLORIDE AS MANUFACTURED IN ZOFINGEN, SWITZERLAND.

ZHEJIANG HISUN PHARMACEUTICAL CO LTD MESNA AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

DRY-FLOC(R) PC AESTHETIC ENHANCER AS MANUFACTURED IN ISLAND FALS, ME. EPIRUBICIN HYDROCHLORIDE AS MANUFACTURED IN DONETSK, UKRAINE. LAMOTRIGINE AS MANUFACTURED IN BEER SHEVA, ISRAEL. THAUMATIN AS MANUFACTURED IN WIRRAL, UNITED KINGDOM.

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4Q2012EXCEL DMF# 16261 16262 16263 16264 C 16265 A 16266 A 16267 16268 16269 A 16270 I 16271 16272 I 16273 16274 16275 A 16276 I 16277 A 16278 16279 16280 16281 C 16282 I 16283 16284 16285 16286 16287 16288 16289 16290 A 16291 A III 12/5/2002 STYROLUTION AMERICA LLC A A A A A I A II IV IV II II II II III 11/28/2002 12/2/2002 12/2/2002 12/4/2002 12/4/2002 12/6/2002 12/5/2002 12/4/2002 AMINO CHEMICALS LTD DMV FONTERRA EXCIPIENTS GMBH CO KG DMV FONTERRA EXCIPIENTS GMBH CO KG AKZO NOBEL CHEMICALS SA DE CV RANBAXY LABORATORIES LTD NV ORGANON INTERQUIM SA RENOLIT HISPANIA SA III 3/5/2003 WINPAK TECHNOLOGIES INC A A A II II II II 11/26/2002 12/2/2002 12/2/2002 12/2/2002 UNICHEM LABORATORIES LTD SMS PHARMACEUTICALS LTD PLIVA LACHEMA AS TEVA PHARMACEUTICAL INDUSTRIES LTD III 11/12/2002 BESPAK DIV CONSORT MEDICAL PLC III 11/19/2002 AMPACET CORP A A II III III 11/25/2002 11/18/2002 11/15/2002 A II II 11/26/2002 11/25/2002 GADOR SA KUNSHAN DOUBLE CRANE PHARMACEUTICAL CO LTD RELIABLE BIOPHARMACEUTICAL CORP POLYONE CORP STE PACKAGING DEVELOPMENT SL NORGESTIMATE AS MANUFACTURED IN BUENOS AIRES, ARGENTINA. METFORMIN HYDROCHLORIDE AS MANUFACTURED IN JIANGSU, CHINA. HYALURONIDASE AS MANUFACTURED IN ST.LOUIS, MO. PRODUCT NO. CC00017894DR AS MANUFACTURED IN AVON LAKE, OH. II 11/21/2002 A A II II V 11/25/2002 11/25/2002 11/26/2002 WOCKHARDT LTD WOCKHARDT LTD III 11/20/2002 PRESSPART MANUFACTURING LTD II 11/25/2002 FERMIC SA DE CV STATUS Type SUBMIT DATE A A A II II II II 11/27/2002 11/27/2002 11/18/2002 11/25/2002 HOLDER RANBAXY LABORATORIES LTD TARO PHARMACEUTICAL INDUSTRIES LTD UNICHEM LABORATORIES LTD FERMIC SA DE CV SUBJECT QUINAPRIL HYDROCHLORIDE AS MANUFACTURED IN PUNJAB, INDIA. CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN HAIFA BAY, ISRAEL. METRONIDAZOLE (ESUB) AS MANUFACTURED IN RAIGAD, INDIA.

4Q2012

CLAVULANATE POTASSIUM+SILICON DIOXIDE AS MANUFACTURED IN MEXICO CITY, MEXICO. CLAVULANATE POTASSIUM+MICROCRYSTALLINE CELLULOSE AS MANUFACTURED IN MEXICO CITY, MEXICO. STAINLESS STEEL AEROSOL CANISTERS AS MANUFACTURED IN LANCASHIRE, ENGLAND. CEFUROXIME AXETIL(AMORPHOUS) AS MANUFACTURED IN GUJARAT STATE, INDIA. AZITHROMYCIN-FORM I AS MANUFACTURED IN GUJARAT STATE, INDIA.

NATIONAL INSTITUTES HEALTH NATIONAL CURRICULA VITAE (CV) FOR HIV PREVENTION TRIALS NETWORK (HPTN) INSTITUTE ALLERGY INFECTIOUS DISEASES INVESTIGATORS. SICOR SPA DOXORUBICIN HYDROCHLORIDE, LYOPHILIZED AS MANUFACTURED IN VERCELLI, ITALY.

PLASTIC MOLDED COMPONENTS FOR PACKAGING AND DELIVERY OF PHARMACEUTICAL PRODUCTS AS MANUFACTURED IN TARRAGONA, SPAIN. 12416 PEARL POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; TERRE HAUTE, IN; CARTERSVILLE, GA; LATEXO, TX; HEATH, OH AND DERIDDER, LA. BK357951MT PHARMACEUTICAL METERING VALVE AS MANUFACTURED IN NORFOLK, ENGLAND. HYDROCHLOROTHIAZIDE USP (ESUB) AS MANUFACTURED IN RAIGAD, INDIA. SUMATRIPTAN SUCCINATE AS MANUFACTURED IN ANDHRA PRADES, INDIA. CARBOPLATIN AS MANUFACTURED IN BRNO, THE CZEH REPUBLIC. VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN BE'ER SHEVA AND NETANYA, ISRAEL. 41.0 GSM PAPER DUNCOTE II HG 605/11.0 GSM PE 5050/24.1 GSM9.0 UM ALUMINIUM FOIL/16.0 GSM EAA TRANCEND EC AS MANUFACTURED IN TORONTO, CANADA. TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN MARSA, MALTA. RESPITOSE ML002 AS MANUFACTURED IN VEGHEL, THE NETHERLANDS. RESPITOSE SV003 AS MANUFACTURED IN VEGHEL, THE NETHERLANDS. PERKADOX API (BENZOYL PEROXIDE) AS MANUFACTURED IN LOS REYES, MEXICO. GABAPENTIN (NON-STERILE BULK) AS MANUFACTURED IN MADHYA PRADESH, INDIA. ESTERIFIED ESTROGENS TYPE BA AS MANUFACTURED IN OSS, THE NETHERLANDS. ABAPERIDONE HYDROCHLORIDE AS MANUFACTURED IN BARCELONA, SPAIN. RENOLIT PHARMAFOLIE ART.-GRUPPE 41 AS MANUFACTURED IN WORMS AM RHEIN, GERMANY. ZYLAR(R) RESINS AS MANUFACTURED IN CHESAPEAKE, VA.

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4Q2012EXCEL DMF# 16292 16293 16294 A 16295 A 16296 A 16297 16298 I 16299 A 16300 A 16301 A 16302 I 16303 I 16304 16305 A 16306 16307 A 16308 I 16309 A 16310 16311 16312 16313 16314 16315 16316 16317 16318 A I A A A I A A A II II II II II II II II III 12/13/2002 12/16/2002 12/11/2002 12/17/2002 12/17/2002 12/17/2002 1/27/2003 12/13/2002 12/18/2002 II 12/13/2002 III 11/25/2002 BESPAK EUROPE LTD A II V 12/12/2002 12/12/2002 A II II 11/28/2002 12/11/2002 III 12/2/2002 BERRY PLASTICS CORP TAPES AND COATINGS DIV POLFA TARCHOMIN S A III 12/10/2002 II 12/5/2002 ERREDUE SPA INNOVATIVE CHEMICAL AND LIFE STELLA KUNSTSTOFFTECHNIK GMBH II 12/11/2002 RANBAXY LABORATORIES LTD II 12/10/2002 A II III 12/2/2002 12/2/2002 CADILA HEALTHCARE LTD BERRY PLASTICS CORP TAPES AND COATINGS DIV III 12/6/2002 LOPAREX LLC III 12/6/2002 LOPAREX LLC STATUS Type SUBMIT DATE I A II III III 12/10/2002 11/27/2002 12/6/2002 HOLDER COLLGARD BIOPHARMACEUTICALS LTD BASF SE LOPAREX LLC SUBJECT

4Q2012

HALOFUGINONE HYDROBROMIDE AS MANUFACTURED IN VERTOLAYE, FRANCE. ULTRAFORM W 2320 003 UNCOLORED Q600 AS MANUFACTURED IN BISHOP, TX. RELEASE LINERS MADE WITH TIN CURE CHEMISTRY ON POLYESTER FILM SUBSTRATES AS MANUFACTURED IN IOWA CITY, IA; EDEN, NC; DIXON, IL AND CULLMAN, AL. RELEASE LINERS MADE WITH PLATINUM CURE CHEMISTRY ON POLYETHYLENE COATED KRAFT PAPER AS MANUFACTURED IN IOWA CITY, IA; EDEN, NC; DIXON, IL AND CULLMAN, AL. RELEASE LINERS MADE WITH PLATINUM CURE CHEMISTRY ON POLYESTER SUBSTRATES AS MANUFACTURED IN IOWA CITY, IA; EDEN, NC; DIXON, IL AND CULLMAN, AL. FLUCONAZOLE AS MANUFACTURED IN GUJARAT, INDIA. 48 GAUGE CHEMICALLY TREATED POLYESTER/PRIMER/12# WHITE POLYETHYLENE/0.00035 FOIL/1.0# ADHESIVE/2 MIL LDPE FILM AS MANUFACTURED IN COLUMBUS, GA.

CSPC HEBEI ZHONGRUN PHARMACEUTICAL 7-AMINOCEPHALOSPORANIC ACID 7-ACA (ESUB) AS MANUFACTURED IN HEBEI CO LTD PROVINCE, CHINA. VALACYCLOVIR HYDROCHLORIDE (NON-STERILE BULK) AS MANUFACTURED IN MADHYA PRADESH, INDIA. PHENYTOIN SODIUM AS MNAUFACTURED IN ISSO, ITALY. SECRO PP28, CHILD-PROFF CLOSURE, WHITE/YELLOW WITH SEALING DISK AS MANUFACTURED IN ELTVILLE, FEDERAL REPUBLIC OF GERMANY. 48 GAUGE CHEMICALLY TREATED POLYESTER/0.8# ADHESIVE/0.00035 FOIL/0.8# ADHESIVE/2 MIL LDPE FILM AS MANUFACTURED IN COLUMBUS, GA. ERYTHROMYCIN THIOCYANATE AS MANUFACTURED IN WARSAW, POLAND.

ZHEJIANG HISUN PHARMACEUTICAL CO LTD SIMVASTATIN USP, NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. MYLAN LABORATORIES LTD MODAFINIL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. LILLY FRANCE SAS PROCEDURES FOR STERILE OPERATIONS (ESUB) IN BUILDING 200, FEGERSHEIM, FRANCE.

BK 357676MT PHARMACEUTICAL METERING VALVE AS MANUFACTURED IN NORFOLK, ENGLAND. ZHEJIANG HISUN PHARMACEUTICAL CO LTD PRAVASTATIN SODIUM (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. TEVA PHARMACEUTICAL INDUSTRIES LTD MODAFINIL AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. MAPRIMED SA KATWIJK CHEMIE BV SANDOZ PRIVATE LTD TEVA PHARMACEUTICAL INDUSTRIES LTD RELIABLE BIOPHARMACEUTICAL CORP DR REDDYS LABORATORIES LTD INKE SA IWATA GLASS INDUSTRIAL CO LTD LOSARTAN POTASSIUM AS MANUFACTURED IN BUENOS AIRES, ARGENTINA. DIVALPROEX SODIUM AS MANUFACTURED IN KATWIJK, THE NETHERLANDS. CEFIXIME AS MANUFACTURED IN MAHARASHTRA, INDIA. LABETALOL HYDROCHLORIDE AS MANUFACTURED IN SETTIMO MILANESE MI, ITALY. APROTININ AS MANUFACTURED IN ST.LOUIS, MO. FLUCONAZOLE (FORM 2) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ONDANSETRON HYDROCHLORIDE AS MANUFACTURED IN BARCELONA, SPAIN. DRUG AMPULES AND VIALS AS MANUFACTURED IN OSAKA, JAPAN.

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4Q2012EXCEL DMF# 16319 A 16320 16321 16322 A 16323 A 16324 A 16325 16326 16327 16328 I 16329 16330 16331 C 16332 16333 16334 16335 16336 16337 16338 16339 16340 16341 16342 16343 16344 16345 16346 16347 16348 16349 16350 16351 16352 16353 16354 A I I A I I A A A A A I A A A I I I A A A A A II II II II II III III II II III II II II II II II II II II II II II III 12/19/2002 12/20/2002 12/20/2002 12/18/2002 12/17/2002 12/18/2002 12/18/2002 12/26/2002 12/18/2002 12/13/2002 12/30/2002 12/24/2002 12/20/2002 12/20/2002 1/3/2003 1/3/2003 1/2/2003 1/6/2003 1/23/2003 12/6/2002 1/2/2003 12/30/2002 1/6/2003 DOTTIKON EXCLUSIVE SYNTHESIS AG HEUMANN PHARMA GMBH HOVIONE FARMACIENCIA SA OMNICHEM SA DAITO CORP BERRY PLASTICS CORP BERRY PLASTICS CORP TARO PHARMACEUTICAL INDUSTRIES LTD LONZA AG POLYONE CORP PROCOS SPA SANYO FINE CO LTD CHEMPACIFIC CORP ANDHRA SUGARS LTD DIOSYNTH BV DIOSYNTH BV WENZHOU PHARMACEUTICAL FACTORY SANYO CHEMICAL INDUSTRIES LTD OLON SPA PURDUE PHARMA LP ERREGIERRE SPA ERREGIERRE SPA ADVANEX EUROPE LTD I A II II II 12/16/2002 1/29/2003 12/20/2002 SAFC INC DR REDDYS LABORATORIES LTD CHATTEM CHEMICALS INC I A A II II II III 12/19/2002 12/19/2002 12/23/2002 12/24/2002 II 12/18/2002 II 12/3/2002 A A II II III 1/29/2003 12/17/2002 12/18/2002 DR REDDYS LABORATORIES LTD RANBAXY LABORATORIES LTD LORMAC INDUSTRIAL DISTRIBUTORS LTD STATUS Type SUBMIT DATE V 12/9/2002 HOLDER PFIZER PERTH PTY LTD SUBJECT

4Q2012

PERTH ASEPTIC ONCOLOGY MANUFACTURING FACILITY IN WESTERN AUSTRALIA, AUSTRALIA. ONDANSETRON AS MANUFACTURED IN ANDHRA PRADESH, INDIA. FOSINOPRIL SODIUM (NON-STERILE BULK) AS MANUFACTURED IN PUNJAB, INDIA.

LORMAC TYPE 30 POLYETHYLENE BAGS AS MANUFACTURED IN CORK, IRELAND AND BRADFORD, ENGLAND. SUN CHEMICALS CO LTD BENZYL (3S)-1,2,3,4-TETRAHYDROISOQUINOLINE-3-CARBOXYLATE P-TOLUENESULFONIC ACID SALT AS MANUFACTURED SAITAMA, JAPAN. ZHEJIANG HISUN PHARMACEUTICAL CO LTD EPIRUBICIN HYDROCHLORIDE, NON-STERILE BULK DRUG AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. FARMABIOS SPA CEFUROXIME SODIUM (INTERMEDIATE) AS MANUFACTURED IN PAVIA, ITALY. PLIVA LACHEMA AS 5N PLUS LUBECK GMBH PPG INDUSTRIES INC DACARBAZINE AS MANUFACTURED IN BRNO, THE CZECH REPUBLIC. BISMUTH SUBSALICYLATE SG AS MANUFACTURED IN LUBECK, GERMANY. COVERING PPG2004855 COATING FOR AEROSOL CANS CONTAINING DRUG PRODUCT AS MANUFACTURED IN OAK CREEK, WI AND DELAWARE, OH. HALOBETASOL PROPIONATE (HBS) AS MANUFACTURED IN MADISON, WI. CARVEDILOL FORM-2 AS MANUFACTURED IN ANDHRA PRADESH, INDIA. METHYLPHENIDATE HYDROCHLORIDE, USP AS MANUFACTURED IN CHATTANOOGA, TENNESSEE. T-3811A05 AS MANUFACTURED IN DOTTIKON, SWITZERLAND. CARPROFEN AS MANUFACTURED IN FEUCHT, GERMANY. FLUTICASONE PROPIONATE AS MANUFACTURED IN LOURES, PROTUGAL. T-3811A15 AS MANUFACTURED IN BALEN, BELGIUM. FLAVOXATE HYDROCHLORIDE JP14 AS MANUFACTURED IN TOYAMA CITY, JAPAN. PRODUCT 15807-55 AS MANUFACTURED IN COLUMBUS, GA PRODUCT 60091-21 MANUFACTURED IN COLUMBUS, GA OXCARBAZEPINE AS MANUFACTURED IN HAIFA BAY, ISRAEL. CN 343 (SAS) AS MANUFACTURED IN VISP, SWITZERLAND. PRODUCT NO. CC00017075WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL. GABAPENTIN AS MANUFACTURED IN NOVARA, ITALY. HMMP AS MANUFACTURED IN FUKUI PREFECTURE, JAPAN. NOREPINEPHRINE BITARTRATE AS MANUFACTURED IN BALTIMORE, MD. ASPIRIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ALTRENOGEST AS MANUFACTURED IN OSS, THE NETHERLANDS. TRENBOLONE ACETATE AS MANUFACTURED IN OSS, THE NETHERLANDS. ACETAMINOPHEN DC GRANULAR AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. POLYQUID PA-30 AS MANUFACTURED IN AICHI, JAPAN. CEFUROXIME AXETIL AS MANUFACTURED IN RODANO, ITALY AND CHENNAI, INDIA. HYDROMORPHONE HYDROCHLORIDE AS MANUFACTURED IN WHIPPANY, NJ. CICLOPIROX OLAMINE USP-PH.EUR. AS MANUFACTURED IN BERGAMO, ITALY. CICLOPIROX PH.EUR. AS MANUFACTURED IN BERGAMO, ITALY. GSK MDI COUNTER WIRE FORMS AS MANUFACTURED IN NOTTINGHAMSHIRE, ENGLAND.

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4Q2012EXCEL DMF# 16355 16356 A 16357 A 16358 I 16359 I 16360 A 16361 A 16362 A 16363 A 16364 I 16365 16366 16367 16368 16369 16370 16371 16372 16373 16374 16375 16376 A 16377 A 16378 I 16379 A 16380 A 16381 16382 16383 I I N II III 1/22/2003 1/20/2003 II 1/16/2003 II 1/23/2003 III 1/22/2003 ACI PLASTICS PACKAGING CLOSURE SPECIALTY PRODUCTS ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD TIANJIN ZHONGAN PHARMACEUTICAL CO LTD RANBAXY LABORATORIES LTD OWENS ILLINOIS INC NOT AN ASSIGNED NUMBER III 1/21/2003 LANXESS CORP A A A A A I A I A A I III IV II III II II II II III II II IV 1/16/2003 1/15/2003 1/17/2003 1/21/2003 1/21/2003 1/16/2003 1/20/2003 1/17/2003 11/26/2002 1/21/2003 1/21/2003 1/2/2003 FORTEQ NIDAU AG KERRY CANADA INC MEDICHEM SA ZEON CORP SHASUN PHARMACEUTICALS LTD PHLOX PHARMACEUTICALS LTD NEULAND LABORATORIES LTD SYNTETICA FINE CHEMICALS INC BASF SE PHYTON BIOTECH LLC HOVIONE FARMACIENCIA SA CAPSCANADA CORP III 1/16/2003 ALKERMES INC III 1/15/2003 LORMAC INDUSTRIAL DISTRIBUTORS LTD IV 1/16/2003 SPI PHARMA INC II 1/15/2003 III 1/13/2003 II 1/10/2003 AVANTI POLAR LIPIDS INC II 1/10/2003 II 1/23/2003 CHONGQING CARE LIFE PHARMACEUTICAL CO LTD AVANTI POLAR LIPIDS INC STATUS Type SUBMIT DATE A II II 1/14/2003 1/13/2003 HOLDER NITTO DENKO CORP SAFC BIOSCIENCES INC SUBJECT OLIGONUCLEOTIDE APQ AS MANUFACTURED IN MILFORD, MA.

4Q2012

EX-CELL(TM) 302, SERUM-FREE MEDIUM, W/O L-GLUTAMINE, W/O NAHCO3 AS MANUFACTURED IN DENVER, PA. CLINDAMYCIN PHOSPHATE AS MANUFACTURED IN CHONGQING, PEOPLE'S REPUBLIC OF CHINA. 3-O-[2'-(W-MONOMETHOXYPOLY(ETHYLENE GLYCOL)2000)SUCCINOLY]-1,2-DISTEAROYLSN-GLYCEROL (DSG-PEG 2000) AS MANUFACTURED IN ALABASTER, AL. 1,2-DI-O-OCTADECENYL-3-(N,N-DIEMTHYLAMINOPROPANE) (DODMA) AS MANUFACTURED IN ALABASTER, AL. OXYGEN ABSORBERS AGELESS TYPES ZPT, ZP (ZPT-C) AND SS AS MANUFACTURED IN TOKYO, JAPAN. 2-BUTYL-4-CHLORO-1-[[2'-[2-(TRIPHENYLMETHYL)-2H-TETRAZOL-5-YL]-[1,1'-BIPHENYL]-4YL]METHYL]1-H-IMIDAZOLE-5-METHANOL (TTL) AS MANUFACTURED IN CONSHOHOCKEN, PA. MANNOGEM(TM) EZ SPRAY DRIED MANNITOL USP AS MANUFACTURED IN KENT, ENGLAND. LORMAC TYPE 7-B POLYETHYLENE AS MANUFACTURED IN CORK, IRELAND AND WEST YORKSHIRE, UNITED KINGDOM. C2S DRY POWDER INHALER DRUG DELIVERY SYSTEMS AS MANUFACTURED IN CAMBRIDGE, MA. MDI COUNTER PROJECT AS MANUFACTRUED IN NIDAU, SWITZERLAND. BUBBLEGUM ARTIFICIAL FLAVOR MC-4938 AS MANUFACTURED IN QUEBEC, CANADA. ALENDRONATE SODIUM AS MANUFACTURED IN GIRONA, SPAIN. CYCLOOLEFIN POLYMER AS MANUFACTURED IN OKAYAMA, JAPAN. ISRADIPINE, USP AS MANUFACTURED IN CUDDALORE, INDIA. CEFUROXIME ACID AS MANUFACTURED IN GUJARA, INDIA. ALBUTEROL SULFATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. AMONAFIDE L-MALATE AS MANUFACTURED IN QUEBEC, CANADA. ULTRAFORM N 2320 003 UNCOLORED Q600 AS MANUFACTURED IN BISHOP, TX. SEMI-SYNTHETIC PACLITAXEL API AS MANUFACTURED IN GRAFTON, WI. T-3811A15 (17TY01) AS MANUFACTURED IN LOURES, PORTUGAL. EMPTY HARD VEGETABLE CAPSULE SHELLS AS MANUFACTURED IN BARRANQUILLA, COLUMBIA. CHLOROBUTYL 1240 AS MANUFACTURED IN SARINA, CANADA AND ANTWERPEN, BELGIUM. ARGUS-LOC TAMPERTEL CRC CLOSURES AS MANUFACTURED IN VICTORIA, AUSTRALIA. SULFADIMETHOXINE SODIUM USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. METRONIDAZOLE AS MANUFACTURED IN TIANJIN, P.R.CHINA. T-3811A 05 AS MANUFACTURED IN MADHYA PRADESH, INDIA. PLASTICS PACKAGING COMPONENTS AS MANUFACTURED IN EL PASO, TX.

Methyl Beta-Cyclodextrin
JOHNSON MATTHEY PHARMACEUTICAL MATERIALS

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4Q2012EXCEL DMF# 16384 A 16385 A 16386 16387 A 16388 A 16389 16390 A 16391 16392 I 16393 16394 A 16395 16396 16397 I 16398 16399 16400 A 16401 I 16402 A 16403 16404 16405 16406 16407 16408 16409 16410 16411 16412 A 16413 16414 A A III II 2/4/2003 2/7/2003 BAXA CORP SENJU PHARMACEUTICAL CO LTD A A A A I A A I A III II II II II III II II II III 1/31/2003 2/3/2003 1/30/2003 1/20/2003 1/20/2003 2/5/2003 4/23/2003 2/3/2003 1/31/2003 2/4/2003 MITSUBISHI GAS CHEMICAL CO INC GEDEON RICHTER PLC ALKALOIDA CHEMICAL CO ZRT BIOCON LTD BIOCON INDIA LTD WACKER CHEMIE AG MYLAN LABORATORIES LTD ROHIT PLASTICS AND CHEMICALS GMT FINE CHEMCALS SA BAXA CORP II 2/3/2003 CATALENT PHARMA SOLUTIONS LLC II 2/3/2003 RANBAXY LABORATORIES INC A A II II II 1/29/2003 2/3/2003 1/31/2003 A I IV II III 1/23/2003 2/3/2003 1/31/2003 MANE INC LABORATORI DERIVATI ORGANICI SPA I III III 1/31/2003 1/15/2003 BASF CORP AMPACET CORP ACRONAL(R) N-CR 112 AS MANUFACTURED IN MONACA, PA. I II III 11/26/2002 1/27/2003 CADILA PHARMACEUTICALS LTD SOMAR CORP A II II 1/25/2003 1/30/2003 EUTICALS SPA SANDOZ INDUSTRIAL PRODUCTS SA III 1/24/2003 CURTEC NEDERLAND BV A III II 1/24/2003 1/28/2003 ASHLAND INC SIGNA SA DE CV FLEXCRYL(R) SP-38 EMULSION AS MANUFACTURED IN PIEDMONT, SC. II 1/22/2003 EXPRESSION SYSTEMS LLC STATUS Type SUBMIT DATE II 1/22/2003 HOLDER EXPRESSION SYSTEMS LLC SUBJECT

4Q2012

ESF 921 MEDIUM (A SERUM FREE FORMULATION) AS MANUFACTURED IN WOODLAND, CA. AF 99 MEDIUM (AN ANIMAL FREE FORMULATION) AS MANUFACTURED IN WOODLAND, CA.

NEFAZODONE HYDROCHLORIDE AS MANUFACTURED IN TOLUCA, MEXICO AND GUJARAT, INDIA. CLICK PACK'S 4500 SERIES AND KEGS 6900 AND 7000 SERIES AS MANUFACTURED IN RIJEN, NETHERLANDS. DESOGESTREL BP/PF AS MANUFACTURED IN ROZZANO, ITALY. AZITHROMYCIN MONOHYDRATE (NON-STERILE BULK) AS MANUFACTURED IN BARCELONA, SPAIN. FLUCONAZOLE AS MANUFACTURED IN GUJARAT, INDIA. A MEDICAL BACKING CLOTH: SOMAPET HW-25 AS MANUFACTURED IN SAITAMA, JAPAN.

111203 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; TERRE HAUTE, IN; CARTERSVILLE, GA; DERIDDER, LA; LATEXO, TX; HEATH, OH AND MESSANCY, BELGIUM. SPEARMINT FLAVOR S.D. E_9822433 AS MANUFACTURED IN BAR-SUR-LOUP, FRANCE. SODIUM HEPARIN AS MANUFACTURED IN VERCELLI, ITALY.

INTERNATIONAL MEDICATION SYSTEMS LTD EMPTY PREFILLED DISPOSABLE PIPETTE (PDP), D SERIES TYPES: D1000, D 2500, D5000, AND D10K AS MANUFACTURED IN SAN FERNANDO, CA. UNICHEM LABORATORIES LTD BISOPROLOL HEMIFUMARATE (ESUB) AS MANUFACTURED IN RAIGAD, INDIA. RHODES TECHNOLOGIES AIR LIQUIDE HEALTHCARE AMERICA CORP OXYCODONE HYDROCHLORIDE AS MANUFACTURED IN COVENTRY, RI. PERFLUOROPROPANE (OCTOFLUROPROPANE) GAS MANUFACTURED IN PLUMSTEADVILLE, PA. COMPACTIN DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN HIMACHAL PRADESH, INDIA. ZEMPLAR (PARICALCITOL) 2 & 4 MCG CAPSULES AS MANUFACTURED IN ST.PETERSBURG, FL. OXYGEN ABSORBERS AGELESS TYPE FX AS MANUFACTURED IN TOKYO, JAPAN. NORELGESTROMIN AS MANUFACTURED IN DOROG, HUNGARY. TOPIRAMATE AS MANUFACTURED IN TISZAVASVARI, HUNGARY. MYCOPHENOLATE MOFETIL AS MANUFACTURED IN BANGALORE, INDIA. MYCOPHENOLIC ACID AS MANUFACTURED IN BANGALORE, INDIA. ELASTOSIL(R) R 409/70 MH, AS MANUFACTURED IN NUNCHRITZ, GERMANY ALLOPURINOL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CHLORHEXIDINE BASE AS MANUFACTURED IN MAHARASHTRA, INDIA. DACARBAZINE USP AS MANUFACTURED IN COUVET, SWITZERLAND. PRESS-IN BOTTLE ADAPTERS AND PRESS-IN BOTTLE WELL ASSEMBLIES AS MANUFACTURED IN ENGLEWOOD, CO; POTTSTOWN, PA AND BLOOMINGTON, IN. EXACTA-MED(R) ORAL LIQUID DISPENSER AS MANUFACTURED IN RODBY, DENMARK. BROMFENAC SODIUM AS MANUFACTURED IN MORTON GROVE, IL.

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4Q2012EXCEL DMF# 16415 A 16416 A 16417 16418 16419 C 16420 16421 I 16422 I 16423 16424 16425 16426 I 16427 16428 16429 I 16430 16431 I 16432 16433 A 16434 16435 16436 16437 16438 I 16439 A 16440 A 16441 16442 A 16443 A III 2/14/2003 FPC FLEXIBLE PACKAGING CORP I IV II 2/25/2003 2/28/2003 HAYASHIBARA CO LTD SIGMA ALDRICH CORP II 2/25/2003 CHEMWERTH INC II 2/19/2003 HOSPIRA BOULDER INC A I I A III III III III II 2/19/2003 2/18/2003 2/11/2003 2/11/2003 2/10/2003 JOE PIETRYKA INC ALVEO AG ROLLPRINT PACKAGING PRODUCTS INC ROLLPRINT PACKAGING PRODUCTS INC TAKASAGO INTERNATIONAL CORP A II II 2/17/2003 2/21/2003 AMSA SPA ALKERMES GAINESVILLE LLC A II II 3/11/2003 2/17/2003 JUBILANT LIFE SCIENCES LTD SUN PHARMACEUTICAL INDUSTRIES LTD A A II II IV 1/21/2003 2/13/2003 2/17/2003 CKD BIO CORP INDUSTRIALE CHIMICA SRL LIPOID GMBH A A A II II II III 2/12/2003 2/5/2003 2/17/2003 2/14/2003 STERLING SRL BACHEM SA PHARMAZELL GMBH AMPHASTAR PHARMACEUTICALS INC FLUTICASONE PROPIONATE AS MANUFACTURED IN PERUGIA, ITALY. RESVERATROL AS MANUFACTURED IN VIONNAZ, SWITZERLAND. BALSALAZIDE DISODIUM AS MANUFACTURED IN RAUBLING, GERMANY. II 2/10/2003 UNIV MISSOURI COLUMBIA A II II 2/10/2003 1/10/2003 SIGNA SA DE CV MDS NORDION I A II II II 2/6/2003 2/4/2003 1/29/2003 CHEMAGIS LTD FILTROX AG TEVA PHARMACEUTICAL INDUSTRIES LTD II 2/6/2003 TEVA PHARMACEUTICAL INDUSTRIES LTD STATUS Type SUBMIT DATE III 1/29/2003 HOLDER COPE ALLMAN JAYCARE LTD SUBJECT

4Q2012

22OZ AND 30OZ ROUND PACKERS AS MANUFACTURED IN NEW CASTLE UPON TYNE, ENGLAND. PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN BE'ER SHEVA AND PETAH TIQVA, ISRAEL. MIDODRINE HYDROCHLORIDE AS MANUFACTURED IN BEER SHEVA, ISRAEL. DEPTH FILTER SHEETS AS MANUFACTURED IN ST.GALLEN, SWITZERLAND. BUPRENORPHINE HYDROCHLORIDE AS MANUFACTURED IN OPAVA-KAMAROV, CZECH REPUBLIC. FLUCONAZOLE AS MANUFACTURED IN TOLUCA, MEXICO. ALTROPANE(R) [123I]-E-IACFT INJECTION AS MANUFACTURED IN VANCOUVER, CANADA. HO-166 CHLORIDE (166 HOCL3) RADIOCHEMICAL AS MANUFACTURED IN COLUMBIA, MO.

PROCESSING FOR WASHING, DEPYROGENAING, SILICONIZING, STERILIZING AND PACKAGING OF STERILE STOPPERS AS MANUFACTURED IN RANCHO CUCAMONGA, CA. CLAVULANATE POTASSIUM AS MANUFACTURED IN KYUNGGI-DO, SOUTH KOREA. PHENTOLAMINE MESILATE AS MANUFACTURED IN SARONNO, ITALY. LIPOID TG 8:0/8:0/8:0 (TRICAPRYLIN) AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY. OXCARBAZEPINE AS MANUFACTURED IN KARNATAKA STREET, INDIA. MESALAMINE USP (5-AMINO SALICYLIC ACID) AS MANUFACTURED IN MAHARASHTRA, INDIA. TOLMETIN SODIUM (ESUB) AS MANUFACTURED IN COMO, ITALY. AVINZA(TM) (MORPHINE SULFATE EXTENDED-RELEASE CAPSULES) 30MG, 60MG, 90MG AND 120MG AS MANUFACTURED IN GAINESVILLE, GA. DOSAGE CUPS AS MANUFACTURED IN PAWLING, NY. ALVEOLIT(R) TE POLYMER FOAMS AS MANUFACTURED IN LUCERNE, SWITZERLAND. RPP#33-2023 AS MANUFACTURED IN ADDISON, IL AND BLOOMFIELD, CT. RPP#31-6151 AS MANUFACTURED IN ADDISON, IL AND BLOOMFIELD, CT. 4-AA (NEW CATALYST VERSION) AS MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN. PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN MORTON GROVE, IL AND BOULDER, CO. ANAGRELIDE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN FREIBURG IM BREISGAU, GERMANY FOR CHEMWERTH INC. HAYASHIBARA PULLULAN AS MANUFACTURED IN OKAYAMA, JAPAN. CHO PROTEIN-FREE MEDIUM WITHOUT L-GLUTAMINE AS MANUFACTURED IN ST.LOUIS, MO AND IRVINE, AYRSHIRE, SCOTLAND, UNITED KINGDOM. PAPER/POLYESTER/FOIL/POLYETHYLENE POUCH VERSION B AS MANUFACTURED IN ONTARIO, CANADA.

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4Q2012EXCEL DMF# 16444 A 16445 A 16446 16447 16448 16449 16450 16451 A 16452 16453 16454 16455 16456 16457 A 16458 16459 16460 16461 16462 16463 16464 16465 16466 16467 16468 16469 A 16470 I 16471 I 16472 A 16473 16474 16475 I 16476 A II 3/13/2003 HIKAL LTD A I II II III 3/19/2003 3/18/2003 3/19/2003 II 3/19/2003 III 3/19/2003 COLOR MASTER INC II 3/10/2003 I C A A A A A A A A A II II III III III III III III II II II II 2/21/2003 3/10/2003 3/4/2003 3/4/2003 3/4/2003 12/20/2002 3/4/2003 2/28/2003 3/13/2003 3/12/2003 3/17/2003 3/18/2003 CHEMSPEC TEVA PHARMACEUTICAL INDUSTRIES LTD PLASTICON INDUSTRIAL LTD PLASTICON INDUSTRIAL LTD PLASTICON INDUSTRIAL LTD PLASTICON INDUSTRIAL LTD PLASTICON INDUSTRIAL LTD SCHWABE INCOAT CADILA PHARMACEUTICALS LTD SANDOZ GMBH BIOFAC AS ORGAPHARM SAS A N A A A III III II II 3/3/2003 3/7/2003 2/28/2003 2/28/2003 II 3/7/2003 ACS DOBFAR SPA NOT AN ASSIGNED NUMBER FUJIMORI KOGYO CO LTD VINS PLASTICS LTD SAFC BIOSCIENCES INC SAFC BIOSCIENCES INC A I I I A III II II II III II 2/14/2003 2/27/2003 2/28/2003 3/4/2003 2/27/2003 3/7/2003 INTESYS TECHNOLOGIES INC PROMETIC BIOSCIENCES LTD PRO BIO SINT SPA FDC LTD FORMOSA PLASTICS CORP USA ACS DOBFAR SPA ACTUATORS FOR PACKAGING AS MANUFACTURED IN COSTA MESA, CA. PERFLUOROSORB S AS MANUFACTURED IN ISLE OF MAN, BRITISH ISLES. TRIACETYLURIDINE AS MANUFACTURED IN VARESE, ITALY. METAXALONE AS MANUFACTURED IN MAHARASHTRA STATE, INDIA. III 2/19/2003 ACTION TECHNOLOGY ITALIA SPA STATUS Type SUBMIT DATE III 2/3/2003 HOLDER 3M DRUG DELIVERY SYSTEMS SUBJECT

4Q2012

CICLESONIDE HFA METERED DOSE INHALER ACTUATORS AS MANUFACTURED IN ESSEX, WORCS. AND MANCHESTER, UNITED KINGDOM. FCA 6220 CHLOROBUTYL RUBBER FORMULATION, FKA 6800 NBR RUBBER FORMULATION AND EA 6900 EPDM RUBBER FORMULATION AS MANUFACTURED IN GAGGIANO, ITALY.

FORMOLENE POLYETHYLENE RESINS AS MANUFACTURED IN POINT COMFORT, TX. AMPICILLIN AND SULBACTAM FOR INJECTION, USP (STERILE BULK) AS MANUFACTURED IN MILANO, ITALY. SULBACTAM SODIUM AS MANUFACTURED IN MILANO, ITALY. FILMBYNA **E-0010 BD AS MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN. FLEXIBLE PACKAGING MATERIAL AS MANUFACTURED IN BRADFORD, CANADA. EX-CELL(TM) 293 MEDIUM W/O L-GLUTAMINE AS MANUFACTURED IN DENVER, PA. EX-CELL(TM) 293 MEDIUM W/L-GLUTAMINE, W/O SODIUM BICARBONATE AS MANUFACTURED IN DENVER, PA. HYDROXYUREA AS MANUFACTURED IN KHOPOLI, MS. INDIA. TRAZODONE HYDROCHLORIDE AS MANUFACTURED IN NETANIA, ISRAEL. PA 45 BOTTLE AS MANUFACTURED IN TOKOL, HUNGARY. 10 ML DROPPER BOTTLE AS MANUFACTURED IN TOKOL, HUNGARY. PA 28 BOTTLE AS MANUFACTURED IN TOKOL, HUNGARY. PE BAGS OF DIFFERENT SIZES AS MANUFACTURED IN TOKOL, HUNGARY. PA 10 BOTTLE AS MANUFACTURED IN TOKOL, HUNGARY. SILTABS PVDC COATED PVC FILM AS MANUFACTURED IN DADRA, INDIA. ETHAMBUTOL HYDROCHLORIDE USP SPECIAL AS MANUFACTURED IN GUJARAT, INDIA. CEFTRIAXONE SODIUM (STERILE) AS MANUFACTURED IN TYROL, AUSTRIA. CHONDROITIN SULFATE AS MANUFACTURED IN KASTRUP, DENMARK.

ARTICAINE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN PITHIVIERS, FRANCE. ZHEJIANG HISUN PHARMACEUTICAL CO LTD GRANISETRON AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. RD1166M, FDA RED TINT COLOR CONCENTRATE FOR PLASTICS AS MANUFACTURED IN AVILLA, IN. UNION QUIMICO FARMACEUTICA SA UQUIFA ALLOPURINOL AS MANUFACTURED IN MILAN, ITALY. SA DR REDDYS LABORATORIES LTD AMLODIPINE BESILATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. WOCKHARDT LTD COLOR MASTER INC METFORMIN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA STATE, INDIA. BL1189M, FDA BLUE TINT COLOR CONCENTRATE FOR PLASTICS AS MANUFACTURED IN AVILLA, IN. BUPROPION HYDROCHLORIDE AS MANUFACTURED IN BANGALORE, INDIA.

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4Q2012EXCEL DMF# 16477 16478 16479 A 16480 16481 16482 A 16483 A 16484 A 16485 16486 16487 16488 16489 A 16490 16491 16492 16493 16494 16495 16496 16497 16498 16499 16500 16501 16502 16503 16504 16505 16506 I 16507 16508 16509 16510 16511 16512 A A A C A I III III II II II II 3/4/2003 3/4/2003 4/1/2003 3/21/2003 3/26/2003 3/21/2003 3M DRUG DELIVERY SYSTEMS 3M DRUG DELIVERY SYSTEMS UNICHEM LABORATORIES LTD HETERO DRUGS LTD GEDEON RICHTER LTD ROCHE DIAGNOSTICS GMBH A A C A A A A A A A A A A A I A II II II IV IV IV IV IV IV IV IV IV IV IV II II IV 3/28/2003 3/20/2003 3/26/2003 3/25/2003 3/25/2003 3/25/2003 3/25/2003 3/25/2003 3/25/2003 3/25/2003 3/25/2003 3/25/2003 3/25/2003 3/25/2003 3/25/2003 4/22/2003 12/18/2002 AUROBINDO PHARMA LTD WANBURY LTD FARMABIOS S P A COGNIS GMBH BASF SE BASF SE BASF SE BASF SE BASF SE COGNIS GMBH BASF SE BASF SE BASF SE BASF SE UNICHEM LABORATORIES LTD WATSON PHARMA PRIVATE LTD PERLAROM FRANCE SA I I I I II III III III IV 3/25/2003 3/13/2003 3/13/2003 3/13/2003 3/24/2003 CHEMAGIS LTD LUMELITE PLASTICS LUMELITE PLASTICS LUMELITE PLASTICS MANE INC PREDNICARBATE AS MANUFACTURED IN BEER SHEVA, ISRAEL. CLOSURES AS MANUFACTURED IN PAWLING, NY. APPLICATORS AS MANUFACTURED IN PAWLING, NY. CONTAINERS AS MANUFACTURED IN PAWLING, NY. III 3/7/2003 BOREALIS AG II 3/25/2003 CHEMWERTH INC A A II II II 3/24/2003 3/24/2003 3/26/2003 DR REDDYS LABORATORIES LTD CAMBRIDGE MAJOR LABS INC MANNKIND CORP STATUS Type SUBMIT DATE A I II II II 3/21/2003 3/18/2003 3/19/2003 HOLDER ALEMBIC PHARMACEUTICALS LTD HETERO DRUGS LTD SIGMA ALDRICH CO LTD SUBJECT MODAFINIL AS MANUFACTURED IN GUJARAT, INDIA. AMLODIPINE BESILATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

4Q2012

1,4 DIAMINOBUTANE DIHYDROCHLORIDE AS MANUFACTURED IN DORSET, UNITED KINGDOM. LAMOTRIGINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. MIDODRINE HYDROCHLORIDE AS MANUFACTURED IN GERMANTOWN, WI. INSULIN, HUMAN (RDNA HUMAN INSULIN) HMR 4006 AS MANUFACTURED IN FRANKFURT, GERMANY. SODIUM TETRADECYL SULFATE (STDS)(NON-STERILE BULK DRUG SUBSTANCE)AS MANUFACTURED IN FREIBURG IM BREISGAU, GERMANY FOR CHEMWERTH INC BORMED RB801CF AND BORMED RB801CF-01 AS MANUFACTURED IN BURGHAUSEN, GERMANY.

CHERRY BANANA VANILLA FLAVOR S.D. E_0222033 AS MANUFACTURED IN BAR SUR LOUP, FRANCE. MIRTAZAPINE AS MANUFACTURED IN A.P., INDIA. MEFENAMIC ACID USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. FLURANDRENOLIDE AS MANUFACTURED IN PAVIA, ITALY. EUTANOL(R) G AS MANUFACTURED IN DUESSELDORF, GERMANY. KOLLICREAM(R) OD AS MANUFACTURED IN DUESSELDORF, GERMANY. Kollisolv(R) MCT 70 AS MANUFACTURED IN DUESSELDORF, GERMANY. Kollicream(R) 3C AS MANUFACTURED IN DUESSELDORF, GERMANY. Kollicream(R) OA AS MANUFACTURED IN DUESSELDORF, GERMANY. Kollicream(R) IPM AS MANUFACTURED IN DUESSELDORF, GERMANY. ISOPROPYLPALMITAT PH AS MANUFACTURED IN DUESSELDORF, GERMANY. Kollicream(R) DO AS MANUFACTURED IN DUESSELDORF, GERMANY. Kollicream(R) CP 15 AS MANUFACTURED IN DUESSELDORF, GERMANY. Kolliwax(R) HCO AS MANUFACTURED IN DUESSELDORF, GERMANY. Kolliwax(R) GMS II AS MANUFACTURED IN DUESSELDORF, GERMANY. LEFLUNOMIDE AS MANUFACTURED IN RAIGAD, INDIA. NITROFURANTOIN MONOHYDRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA. STRAWBERRY POWDER SD (PE044587) AS MANUFACTURED IN GRASSE CEDEX, FRANCE. 3M DOUBLE-COATED MEDICAL TAPE #1522 AS MANUFACTURED IN BROOKINGS, SD. 3M MEDICAL TAPE #1523 AS MANUFACTURED IN BROOKINGS, SD. AMLODIPINE BESYLATE (ESUB) AS MANUFACTURED IN RAIGAD, INDIA. LISINOPRIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA. TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN DOROG, HUNGARY. SULFADOXINE AS MANUFACTURED IN MANNHEIM, FEDERAL REPUBLIC OF GERMANY. Page 487

4Q2012EXCEL DMF# 16513 A 16514 16515 16516 16517 16518 16519 A 16520 A 16521 16522 16523 16524 A 16525 16526 16527 16528 A 16529 I 16530 16531 16532 A 16533 16534 16535 16536 16537 I 16538 16539 16540 16541 16542 16543 16544 A 16545 I III 10/1/2003 LAGEEN TUBOBLAST LTD A A A A A I II III III II II II II 4/2/2003 4/10/2003 4/10/2003 4/15/2003 4/15/2003 4/22/2003 4/23/2003 ALZCHEM AG POLYONE CORP POLYONE CORP CHEMAGIS LTD SANDOZ PRIVATE LTD DAIICHI SANKYO CO LTD MYLAN LABORATORIES LTD CREATINE MONOHYDRATE AS MANUFACTURED IN TROSTBERG, GERMANY. A A A I II II II IV IV 3/21/2003 3/21/2003 2/6/2003 1/27/2003 1/27/2003 DR REDDYS LABORATORIES LTD DR REDDYS LABORATORIES LTD DEAD SEA WORKS LTD DAVID MICHAEL AND CO INC DAVID MICHAEL AND CO INC TOPIRAMATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. SUMATRIPTAN SUCCINATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. POTASSIUM CHLORIDE AS MANUFACTURED IN BEER SHEVA, ISRAEL. I A II II II 4/8/2003 3/30/2003 4/1/2003 ZENTIVA A S CADILA HEALTHCARE LTD CARVEDILOL AS MANUFACTURED IN HLOHOVEC, SLOVAKIA. ANAGRELIDE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA. III 4/9/2003 BETTS UK LTD A I A III II IV IV 4/10/2003 4/5/2003 4/4/2003 4/4/2003 C A A II II IV II 4/7/2003 2/27/2003 3/7/2003 4/7/2003 TEVA PHARMACEUTICAL INDUSTRIES LTD TRIFARMA SPA CHP CARBOHYDRATE PIRNA GMBH CO KG BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG SK CHEMICALS CO LTD IPCA LABORATORIES LTD MANE INC MANE INC IV 4/7/2003 LIPOID GMBH A A A A A III III II II II IV 3/17/2004 3/25/2003 4/1/2003 4/8/2003 4/8/2003 4/7/2003 FRANKLIN INTERNATIONAL CHROMA CORP MEDICHEM SA JUBILANT LIFE SCIENCES LTD IND SWIFT LABORATORIES LTD MANE INC STATUS Type SUBMIT DATE III 3/16/2004 HOLDER TEKNOR COLOR CO SUBJECT

4Q2012

ECC1005 WHITE 1% AND ITS COMPOSITION AS MANUFACTURED IN HENDERSON, KY; FOUNTAIN INN, SC; JACKSONVILLE, TX AND LODI, OH. COVINAX 525-08 AS MANUFACTURED IN COLUMBUS, OH. WH08002 WHITE LIQUID COLORANT AS MANUFACTURED IN CHICAGO HEIGHTS, IL. RISPERIDONE AS MANUFACTURED IN GIRONA, SPAIN. RISPERIDONE AS MANUFACTURED IN KARNATAKA STATE, INDIA. CLARITHROMYCIN AS MANUFACTURED IN PUNJAB, INDIA. LEMON ALPINE TOFFEE FLAVOR S.D. E_9947900 AS MANUFACTURED IN BAR-SUR-LOUP, FRANCE. LIPOID SODIUM OLEATE AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY. LEVOFLOXACIN AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. TRANYLCYPROMINE SULFATE AS MANUFACTURED IN MILANO, ITALY. CROSCARMELLOSE USP/NF AS MANUFACTURED IN PIRNA, GERMANY. IFN-OMEGA AS MANUFACTURED IN BIBERACH AN DER RISS, GERMANY. SKYGREEN PETG AS MANUFACTURED IN ULSAN, KOREA. LOSARTAN POTASSIUM AS MANUFACTURED IN MAHARASHTRA, INDIA. ORANGE FLAVOR S.D. E_9816597 AS MANUFACTURED IN BAR-SUR-LOUP, FRANCE. MENTHE ROOTBEER FLAVOR S.D. E_9911748 AS MANUFACTURED IN BAR-SUR-LOUP, FRANCE. METERED DOSE INHALER ACTUATORS AS MANUFACTURED IN ESSEX, UNITED KINGDOM.

ZHEJIANG HISUN PHARMACEUTICAL CO LTD SULBACTAM SODIUM USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

NATURAL PEPPERMINT FLAVOR #23476 AS MANUFACTURED IN PHILADELPHIA, PA. NATURAL FLAVOR #14499 BUBBLE GUM TYPE AS MANUFACTURED IN PHILADELPHIA, PA.

PRODUCT NO. CC10019413WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL. PRODUCT NO. CC10002216WE AS MANUFACTURED IN BROADVIEW HEIGHTS, OH. MUPIROCIN CALCIUM (AMORPHOUS) AS MANUFACTURED IN BEER SHEVA, ISRAEL. CEFPODOXIME PROXETIL AS MANUFACTURED IN MAHARASHTRA, INDIA. CS-917 DRUG PRODUCT AS MANUFACTURED IN TOKYO, JAPAN. CIPROFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. LAMINATE TUBES AS MANUFACTURED IN KIBUTZ YAGUR, ISRAEL.

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4Q2012EXCEL DMF# 16546 I 16547 16548 16549 16550 16551 16552 16553 A 16554 I 16555 16556 16557 16558 16559 A 16560 A 16561 16562 16563 16564 16565 16566 I 16567 A 16568 16569 16570 I A III II III 5/1/2003 6/18/2003 4/25/2003 AIR PRODUCTS AND CHEMICALS INC MICRON TECHNOLOGIES LTD SILGAN PLASTICS CORP FLEXCRYL SP65 AS MANUFACTURED IN PIEDMONT, SC. CONTRACT MICRONIZATION FACILITY IN KENT, UNITED KINGDOM. II 4/29/2003 MALLINCKRODT INC DEXTROAMPHETAMINE BASE (ESUB) AS MANUFACTURED IN ST.LOUIS, MO. A A A A I III II II III III III 4/29/2003 4/23/2003 5/2/2003 4/29/2003 4/25/2003 4/21/2003 II 4/23/2003 A I A A III II V II III 4/10/2003 4/24/2003 4/23/2003 4/28/2003 4/21/2003 MICA CORP ANTIBIOTICE SA ROMANIA CANGENE CORP SCI PHARMTECH INC PT SCHOTT IGAR GLASS MICA A-291-C AS MANUFACTURED IN SHELTON, CT. CYANOCOBALAMIN (VITAMIN B12) AS MANUFACTURED IN IASI, ROMANIA. STERILE PROCESSING FACILITY IN WINNIPEG, MANITOBA, CANADA. VALPROIC ACID AS MANUFACTURED IN TAOYUAN, TAIWAN. III 4/21/2003 AMPACET CORP I A A I A I II IV IV II II II II 4/24/2003 4/23/2003 4/23/2003 4/28/2003 4/29/2003 4/28/2003 4/29/2003 DAIICHI PHARMACEUTICAL CO LTD THERMAX LTD CHEMICAL DIV THERMAX LTD CHEMICAL DIV DAIICHI SANKYO CO LTD ALEMBIC PHARMACEUTICALS LTD MATRIX LABORATORIES LTD CIPLA LTD STATUS Type SUBMIT DATE II 4/22/2003 HOLDER BRISTOL MYERS SQUIBB COMPANY SUBJECT

4Q2012

GARENOXACIN MESYLATE (BMS-284756-01) DRUG SUBSTANCE AS MANUFACTURED IN LATINA, ITALY. DK-507K DRUG SUBSTANCE AS MANUFACTURED IN TOKYO, JAPAN. TULSION(R) 339 AS MANUFACTURED IN MAHARASHTRA, INDI TULSION(R) 344 AS MANUFACTURED IN MAHARASHTRA, INDI CS-917 DRUG SUBSTANCE AS MANUFACTURED IN SHIMANE, JAPAN. VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA. AMLODIPINE MESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CITALOPRAM HYDROBROMIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, BANGALORE, MUMBAI AND VERNA SALCETTE GOA, INDIA. LP-23444 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; TERRE HAUTE, IN; CARTERSVILLE, GA; LATEXO, TX; HEATH, OH AND DERIDDER, LA.

PACKAGING AND DEVICES MADE OF TUBULAR GLASS FOR PHARMACEUTICAL AND COSMETIC APPLICATIONS AS MANUFACTURED IN BEKASI, INDONESIA. ZHEJIANG HISUN PHARMACEUTICAL CO LTD GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF CHINA. JW CHEMITOWN CORPORATION MEDIROLL CT703 FILM AS MANUFACTURED IN KYEONGGI-DO, KOREA. SUN PHARMACEUTICAL INDUSTRIES LTD RANBAXY LABORATORIES LTD BETTS UK LTD CLEAR LAM PACKAGING INC AMPACET CORP ONDANSETRON HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA. CLARITHROMYCIN USP AS MANUFACTURED IN MADHYA PRADESH, INDIA. MDI ACTUATOR AS MANUFACTURED IN ESSEX, UNITED KINGDOM. LAMINATED FILMS FOR PACKAGING AS MANUFACTURED IN ELK GROVE VILLAGE, IL. LP-23443 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; TERRE HAUTE, IN; CARTERSVILLE, GA; LATEXO, TX; HEATH, OH AND DERIDDER, LA.

A 16571 16572 16573 16574 16575 I I A I A III III III III II 4/15/2004 5/1/2003 5/5/2003 4/30/2003 4/30/2003 ROHM AND HAAS CO ASHLAND INC INTELLIGENT DEVICES INC MOLD RITE PLASTICS LLC

PLASTICS BOTTLES, JARS AND CONTAINERS MANUFACTURED BY THE EXTRUSION BLOW-MOLDING PROCESS AS MANUFACTURED IN ANAHEIM AND VALENCIA, CA; OTTAWA AND PORT CLINTON, OH; QUEBEC AND ONTARIO, CANADA; MONROE, GA; SCOTT CITY, MO; DEEP RIVER, CT; HOUST ADCOTE 40-3E AS MANUFACTURED IN ELK GROVE VILLAGE, IL. FLEXCRYL(R) AF2066 AS MANUFACTURED IN PIEDMONT, SC. MED-IC(TM) ECM PACKAGE AS MANUFACTURED IN MULTI-LOCATION. PACKAGING MATERIAL AS MANUFACTURED IN PLATTSBURGH, NY

CHANGZHOU SIYAO PHARMACEUTICALS CO MERCAPTOPURINE USP AS MANUFACTURED IN JIANGSU, CHINA. LTD

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4Q2012EXCEL DMF# 16576 I 16577 A 16578 16579 A 16580 16581 16582 A 16583 16584 I 16585 I 16586 16587 16588 16589 16590 16591 16592 16593 I 16594 A 16595 A 16596 16597 16598 16599 A 16600 I 16601 16602 I 16603 16604 A 16605 A II 5/26/2003 PIRAMAL HEALTHCARE LTD I II II 5/15/2003 5/22/2003 MEDICARB AB TEVA PHARMACEUTICALS INDUSTRIES LTD A II II 5/21/2003 5/20/2003 PCAS AVANTI POLAR LIPIDS INC III 5/16/2003 SPARTECH COLOR I A A II II II IV 5/19/2003 5/15/2003 5/22/2003 5/13/2003 MATRIX LABORATORIES LTD FABBRICA ITALIANA SINTETICI SPA CEDARBURG PHARMACEUTICALS LLC UNGERER AND CO IV 5/8/2003 UNGERER AND CO II 5/14/2003 DR REDDYS LABORATORIES LTD I I A A I A A II II II II III III III II 5/14/2003 5/14/2003 5/15/2003 5/13/2003 5/9/2003 5/9/2003 4/17/2003 5/13/2003 ROHIT PLASTICS AND CHEMICALS MASTAFA NEVZAT ILAC SANAYII EUTICALS SPA EUTICALS SPA DYNIC USA DYNIC USA CORP DYNIC USA CORP ISP CHEMICALS INC III 5/13/2003 LORMAC INDUSTRIAL DISTRIBUTORS LTD I II III 5/12/2003 5/13/2003 GW PHARMA LTD LORMAC INDUSTRIAL DISTRIBUTORS LTD A I II IV II 5/12/2003 5/8/2003 5/12/2003 A II II 5/7/2003 5/9/2003 CHEMISCHE FABRIK BERG GMBH NATIONAL INSTITUTES HEALTH NATIONAL INSTITUTE DRUG ABUSE RANBAXY LABORATORIES LTD BIOFAC A/S CHEMWERTH INC PROPYLTHIOURACIL USP AS MANUFACTURED IN BITTERFELD, GERMANY. COCAINE HYDROCHLORIDE INJECTION, 2 ML (10 MG/ML AND 20 MG/ML) AS MANUFACTURED IN LEXINGTON, KY. ACITRETIN (NON-STERILE BULK) AS MANUFACTURED IN PUNJAB, INDIA. SPLEEN EXTRACT AS MANUFACTURED IN KASTRUP, DENMARK. III 5/9/2003 BD MEDICAL PHARMACEUTICAL SYSTEMS STATUS Type SUBMIT DATE II 5/2/2003 HOLDER NIH NIAID SUBJECT

4Q2012

CHARACTERIZATION OF AEDES ALBOPICTUS (C6/36) MOSQUITO CELL LINE AS MANUFACTURED IN ROCKVILLE, MD. BD STERIFILL(TM) SCF(TM) PLASTIC PREFILLABLE SYRINGE SYSTEM (CRYSTAL CLEAR POLYMER) AS MANUFACTURED IN COLUMBUS, BROKEN BOW AND HOLDREGE, NE.

FENOLDOPAM MESYLATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN FREIBURG IM BREISGAU, GERMANY FOR CHEMWERTH INC CANNABIS BASED MEDICINE AS MANUFACTURED IN WREXHAM, UNITED KINGDOM. LORMAC TYPE 1-E POLYETHYLENE BAGS AS MANUFACTURED IN CORK, IRELAND AND BRIGHOUSE, UNITED KINGDOM. LORMAC TYPE 1-B ANTI-STATIC POLYETHYLENE BAGS AS MANUFACTURED IN CORK, IRELAND AND BRIGHOUSE, UNITED KINGDOM. CHLORHEXIDINE HCL AS MANUFACTURED IN MAHARASHTRA, INDIA. SULBACTAM SODIUM (NON-STERILE) AS MANUFACTURED IN KOCAELI,TURKEY. OXCARBAZEPINE AS MANUFACTURED IN LODI, ITALY. SUCRALFATE AS MANUFACTURED IN LODI, ITALY. HT8 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN. HT8 PLUS INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN. S245 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR. PHENOXYBENZAMINE HYDROCHLORIDE (PBZA) AS MANUFACTURED IN COLUMBUS, OH. ROSIGLITAZONE MALEATE (FORM III) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. LEMON SPRAY DRIED FLAVOURING V3938-1N1 AS MANUFACTURED IN CHESTER AND CEREDIGION, UNITED KINGDOM. AMLODIPINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. OXCARBAZEPINE AS MANUFACTURED IN VICENZA, ITALY. OXANDROLONE USP AS MANUFACTURED IN GRAFTON, WI. NATURAL & ARTIFICIAL CHERRY FLVP FL-8568 AS MANUFACTURED IN BETHLEHEM, PA. BL22995, BLUE POLYPROPYLENE CONCENTRATE AS MANUFACTURED IN ONTARIO, CANADA. APRACLONIDINE HYDROCHLORIDE AS MANUFACTURED IN TURKU, FINLAND. (+)-N-(2-HYDROXYEHTYL-N,N-DIMETHYL-2,3-BIS(TETRADECYLOXY)-1-PROPANIMINIUM BROMIDE (DMRIE-BR) AS MANUFACTURED IN ALABASTER, AL. CHITOSAN AS MANUFACTURED IN BROMMA, SWEDEN. RISEDRONATE SODIUM AS MANUFACTURED IN BE'ER SHEVA AND PETAH TIQVA, ISRAEL. VERAPAMIL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

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4Q2012EXCEL DMF# 16606 16607 I 16608 16609 I 16610 A 16611 16612 A 16613 16614 A 16615 16616 16617 16618 A 16619 I 16620 16621 16622 16623 A 16624 16625 16626 A 16627 A 16628 16629 16630 16631 16632 16633 16634 I 16635 A II 6/11/2003 BIOCON LTD A I I I A A II IV IV II II III II 6/3/2003 5/27/2003 6/11/2003 6/10/2003 6/12/2003 6/12/2003 6/12/2003 INKE SA MCCORMICK AND CO INC VSP TECHNOLOGIES INC AVECIA BIOTECHNOLOGY INC FDC LTD EMMAUS MEDICAL INC ELAN DRUG DELIVERY INC III 6/9/2003 TEKNOR COLOR CO I A II II III 6/2/2003 6/6/2003 6/9/2003 A A A III II II II 5/28/2003 6/19/2003 5/30/2003 6/3/2003 AIRSEC SA MOEHS IBERICA SL SERAVAC BIOTECH (PTY) LTD DESICCATOR WASHER IN PE AS MANUFACTURED IN ROMORANTIN, FRANCE. METOPROLOL SUCCINATE AS MANUFACTURED IN BARCELONA, SPAIN. HYALURONIDASE AS MANUFACTURED IN CAPE TOWN, SOUTH AFRICA. II 6/5/2003 AVON ORGANICS LTD I A I II II II III 5/30/2003 5/29/2003 5/19/2003 6/2/2003 POLYPEPTIDE LABS INC YUHAN CHEMICAL INC SHASUN CHEMICALS AND DRUGS LTD AMPACET CORP I II II 5/19/2003 5/22/2003 HUAHAI PHARMACEUTICAL GROUP CO LTD PHOSPHOLIPID GMBH I III III 5/23/2003 5/12/2003 PLASPAK CLOSURES PTY LTD CEBAL II 5/20/2003 CAMBREX CHARLES CITY INC A II II 6/2/2003 6/2/2003 AVANTI POLAR LIPIDS INC AVANTI POLAR LIPIDS INC STATUS Type SUBMIT DATE A II III 5/21/2003 5/28/2003 HOLDER DYNAMIT NOBEL GMBH RICON COLORS SUBJECT CICLESONIDE AS MANUFACTURED IN LEVERKUSEN, GERMANY.

4Q2012

BLACK, CPP-BK853-1 RAW MATERIAL FOR PACKAGING (CAPS) AS MANUFACTURED IN WEST CHICAGO, IL. L-THREO-DIHYDROSPHINGOSINE (SAFINGOL) AS MANUFACTURED IN ALABASTER, IL. 1,2-DIOLEOYL-3-TRIMETHYLAMMONIUM PROPANE (DOTAP) AS MANUFACTURED IN ALABASTER, AL. METHYLPHENIDATE HYDROCHLORIDE (RITALIN HCL) AS MANUFACTURED IN CHARLES CITY, IOWA. 53MM CLOSURE AS MANUFACTURED IN KIRRAWEE, NSW, AUSTRALIA. HIGH DENSITY POLYETHYLENE (HDPE)/ETHYLENE-VINLY- ALCOHOL (EVOH) COPOLYMER/HDPE TUBES WITH POLYPROPYLENE (PP) CAPS AS MANUFACTURED IN VIENNE LE CHATEAU, VANDIERES, STE MENEHOULD AND ALBERTVILLE, FRANCE. PAROXETINE BASE (BULK) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. PHOSPHOLIPON 90 G (1,2-DIACYL-SN-GLYCERO-3-PHOSPHOCHOLINE) AS MANUFACTURED IN KOLN, GERMANY. KL4 ACETATE (SINAPULTIDE) AS MANUFACTURED IN TORRANCE, CA. LEVOFLOXACIN HEMIHYDRATE AS MANUFACTURED IN KYUNNGI-DO, KOREA. ROFECOXIB AS MANUFACTURED IN CUDDALORE, INDIA. 111150 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; TERRE HAUTE, IN; CARTERSVILLE, GA; DERIDDER, LA; LATEXO, TX; HEATH, OH AND MESSANCY, BELGIUM. EPHEDRINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA

ABX ADVANCED BIOCHEMICAL COMPOUNDS TATM AS MANUFACTURED IN RADEBERG, GERMANY. GMBH ZENTIVA KS ZOLPIDEM TARTRATE AS MANUFACTURED IN HLOHOVEC, SLOVAKIA. GRANULES INDIA LTD TEKNOR COLOR CO METFORMIN HYDROCHLORIDE AS MANUFACTURED IN HYDERABAD, INDIA. 18054 SLIP COLOR CONCENTRATE AS MANUFACTURED IN HENDERSON, KY; FOUNTAIN INN, SC; JACKSONVILLE, TX AND LODI, OH. 93,947CP WHITE 2% COLOR CONCENTRATE AS MANUFACTURED IN HENDERSON, KY; FOUNTAIN INN, SC; JACKSONVILLE, TX AND LODI, OH. FORMOTEROL FUMARATE AS MANUFACTURED IN BARCELONA, SPAIN. FLAVOR FORMULAS AS MANUFACTURED IN HUNT VALLEY, MD. ZYTREL(TM) AS MANUFACTURED IN OSSINING, NY. OLIGONUCLEOTIDE APH AS MANUFACTURED IN MILFORD, MA. FLUCONAZOLE AS MANUFACTURED IN MAHARASHTRA STATE, INDIA. ORAL GLUTAMINE PACKETS AS MANUFACTURED IN ROCKFORD, IL. N1406 (AGI-1067) NANOCRYSTAL(R) WHITE TABLETS, 150 MG AS MANUFACTURED IN KING OF PRUSSIA, PA. PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN BALGALORE, INDIA.

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4Q2012EXCEL DMF# 16636 A 16637 I 16638 16639 16640 16641 A 16642 A 16643 A 16644 16645 16646 I 16647 16648 16649 16650 16651 A 16652 A 16653 16654 16655 16656 I 16657 16658 16659 16660 A 16661 I 16662 16663 16664 16665 16666 16667 16668 A A A A A I A IV IV II II III II II 6/25/2003 6/25/2003 6/20/2003 6/27/2003 6/18/2003 6/27/2003 6/26/2003 MANTROSE HAEUSER CO INC MANTROSE HAEUSER CO INC SUN PHARMACEUTICAL INDUSTRIES LTD CARBOGEN AMCIS AG POLYONE CORP ASTELLAS PHARMA INC SANDOZ PRIVATE LTD III 6/18/2003 TICONA LLC I A A II II II III 6/19/2003 6/24/2003 6/19/2003 6/4/2003 A A A II III III II 6/16/2003 6/9/2003 6/23/2003 6/18/2003 III 6/20/2003 A A I A II II II II III 6/10/2003 6/16/2003 6/16/2003 6/16/2003 6/18/2003 NEULAND LABORATORIES LTD STERLING SRL WOCKHARDT LTD WOCKHARDT LTD A A II II IV 6/11/2003 6/15/2003 6/10/2003 TEVA PHARMACEUTICAL INDUSTRIES LTD CHEMAGIS LTD NATIONAL STARCH CHEMICAL CO V 6/12/2003 SANTEN OY III 6/6/2003 CLARIANT (CANADA) INC I A I II II III II 6/6/2003 6/12/2003 5/23/2003 6/4/2003 ARCHIMICA SRL EMMAUS MEDICAL INC BASF AKTIENGESELLSCHAFT EVESTRA INC BENZOCAINE USP-EP AS MANUFACTURED IN ORGGIO, ITALY. GLUTAMINE PACKETS (ORAL) AS MANUFACTURED IN ROCKFORD, IL. ULTRAFORM H4320 UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN, II 6/12/2003 FH FAULDING AND CO LTD STATUS Type SUBMIT DATE II 6/12/2003 HOLDER CIPLA LTD SUBJECT

4Q2012

ESCITALOPRAM OXALATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, BANGALORE, MUMBAI AND VERNA SALCETTE GOA, INDIA. COATED PARACETAMOL POWDER AS MANUFACTURED IN SALISBURY SA, AUSTRALIA.

DIMETHANDROLONE UNDECANOATE (CDB-4521C) AS MANUFACTURED IN SAN ANTONIO, TX. BROWN CLARIANT MASTERBATCH 06MPG-580 AS MANUFACTURED IN ONTARIO AND QUEBEC, CANADA. STERILIZATION PROCESS FOR CONTINUOUS MOTION (CM1) COMPOUNDING AND FILLING LINE AS MANUFACTURED IN TAMPERE, FINLAND. ONDANSETRON BASE AS MANUFACTURED IN DEBRECEN, HUNGARY. CILOSTAZOL AS MANUFACTURED IN BEER SHEVA, ISRAEL. UNI-PURE(TM) LQ AS MANUFACTURED IN INDIANAPOLIS, IN AND NORTH KANSAS CITY, MO. RAMIPRIL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. MOMETASONE FUROATE AS MANUFACTURED IN PERUGIA, ITALY. CEFUROXIME SODIUM (STERILE) AS MANUFACTURED IN GUJARAT STATE, INDIA. STERILE CEFTRIAXONE SODIUM USP AS MANUFACTURED IN GUJARAT STATE, INDIA.

MARUTANI CHEMICAL PLANT ENGINEERING MK SETCAP AS MANUFACTURED IN IBARAKI, JAPAN. CO LTD CCC PLASTICS CALCIUM STE5ARATE MB355-22 POLYETHYLENE ADDITIVE CONCENTRATE AS MANUFACTURED IN ONTARIO, CANADA. MYTHEN SPA DEFEROXAMINE MESYLATE AS MANUFACTURED IN CORANA, ITALY. BESPAK DIV CONSORT MEDICAL PLC LANXESS CORP ORCHID CHEMICALS AND PHARMACEUTICALS LTD ESTEVE QUIMICA SA DR REDDYS LABORATORIES LTD HIKMA PHARMACEUTICALS COLORTECH INC BESPAK BK690 DISKUS AS MANUFACTURED IN NORFOLK, ENGLAND. BUNA EP T 2450 AS MANUFACTURED IN ORANGE, TX. CEFUROXIME ACID AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA. PANTOPRAZOLE SODIUM AS MANUFACTURED IN CELRA, SPAIN. LEVOFLOXACIN HEMIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CORTISONE ACETATE AS MANUFACTURED IN AMMAN, JORDAN. 11004-18 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN. CELCON(R) MT(TM) ACETAL COPOLYMER AS MANUFACTURED IN BISHOP, TX; FLORENCE, KY AND KELSTERBACH, FEDERAL REPUBLIC OF GERMANY. MANTROCEL HP55-HPMCP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. MANTROCEL E5, E6, E15 AND E50 AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. CARBOPLATIN USP AS MANUFACTURED IN MAHARASHTRA, INDIA. ANECORTAVE ACETATE AS MANUFACTURED IN BUBENDORF, SWITZERLAND. PRODUCT NO. CC1003863460 AS MANUFACTURED IN SEABROOK, TX. FK 881 DRUG SUBSTANCE AS MANUFACTURED IN HYOGO AND OSAKA, JAPAN. CLOFAZIMINE AS MANUFACTURED IN KERALA, INDIA.

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4Q2012EXCEL DMF# 16669 16670 16671 A 16672 A 16673 A 16674 A 16675 16676 16677 A 16678 16679 I 16680 A 16681 I 16682 16683 16684 16685 16686 16687 16688 16689 I 16690 A 16691 A 16692 A 16693 16694 16695 16696 16697 16698 A I A A A A III IV IV II IV II 7/1/2003 6/30/2003 6/30/2003 7/7/2003 7/9/2003 7/1/2003 BERRY PLASTICS CANADA INC CRODA JAPAN KK CRODA JAPAN KK INDUSTRIALE CHIMICA SRL FREUND CORP LONZA LTD III 6/27/2003 AMPACET CORP IV 7/10/2003 FLAVORMATIC INDUSTRIES INC IV 7/10/2003 A A A A A A A II II II III II II II II 7/3/2003 7/3/2003 7/8/2003 7/3/2003 7/8/2003 7/9/2003 7/8/2003 7/10/2003 RANBAXY LABORATORIES LTD SYNKEM SAS USV LIMITED ASHLAND INC ESTEVE QUIMICA SA CHEMICA INC TEVA PHARMACEUTICALS INDUSTRIES LTD SANOFI CHIMIE (A SUBSIDIARY OF SANOFIAVENTIS) FLAVORMATIC INDUSTRIES INC III 7/4/2003 CCC PLASTICS II 6/27/2003 CADILA HEALTHCARE LTD A II III 6/30/2003 6/23/2003 CIPLA LTD CLARIANT (CANADA) INC A A II II II 7/2/2003 6/30/2003 6/30/2003 DR REDDYS LABORATORIES LTD SCINOPHARM TAIWAN LTD CIPLA LTD II 6/30/2003 RANBAXY LABORATORIES LTD III 6/26/2003 BAXA CORP II 6/30/2003 CIPLA LTD STATUS Type SUBMIT DATE A A III II II 6/6/2003 6/25/2003 6/30/2003 HOLDER COMAR INC UCB MANUFACTURING IRELAND LIMITED CIPLA LTD SUBJECT DOSAGE DELIVERY SYSTEMS (ESUB) AS MANUFACTURED IN BUENA, NJ. MOEXIPRIL HYDROCHLORIDE AS MANUFACTURED IN CO. CLARE, IRELAND.

4Q2012

CELECOXIB (ESUB) AS MANUFACTURED IN MAHARASHTRA, BANGALORE, MUMBAI AND VERNA SALCETTE GOA, INDIA. PIOGLITAZONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN PUNE, MAHARASHTRA, INDIA EUROPEAN PRESS-IN BOTTLE ADAPTER AS MANUFACTURED IN CO DURHAM, UNITED KINGDOM. DONEPEZIL HYDROCHLORIDE (NON-STERILE BULK) AS MANUFACTURED IN PUNJAB, INDIA. PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. PACLITAXEL AS MANUFACTURED IN TAINAN COUNTY, TAIWAN. ZIDOVUDINE (ESUB) AS MANUFACTURED IN BAGALORE, MAHARASHTRA, MUMBAI AND VERNA SALCETTE GOA, INDIA. ALBUTEROL SULFATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. BROWN CLARIANT MASTERBATCH 06MPG-659 AS MANUFACTURED IN ONTARIO AND QUEBEC, CANADA. PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN GUJARAT, INDIA. WHITE MB20-9006 POLYETHYLENE COLOR CONCENTRATE AS MANUFACTURED IN ONTARIO, CANADA. PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN PUNJAB, INDIA. TETRABENAZINE AS MANUFACTURED IN CHENOVE CEDEX, FRANCE. PIOGLITAZONE HYDROCHLORIDE (ESUB) AS MANUFACTRUED IN MUMBAI, INDIA. FLEXCRYL(R) AF2020 AS MANUFACTURED IN PIEDMONT, SC. MELOXICAM AS MANUFACTURED IN BARCELONA AND GIRONA, SPAIN. BENZPHETAMINE HYDROCHLORIDE AS MANUFACTURED IN LOS ANGELES, CA. PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. LEVOMEPROMAZINE HYDROCHLORIDE AS MANUFACTURED IN VITRY-SUR-SEINE CEDEX, FRANCE. N&A BANANA CREAM TYPE FLAVOR #909-489 AS MANUFACTURED IN WAPPINGERS FALLS, NY. N&A CHERRY TYPE FLAVOR #909-504 AS MANUFACTURED IN WAPPINGERS FALLS, NY. 11343 WHITE POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA. DOUBLE WALLS THREADED CLOSURES AS MANUFACTURED IN QUEBEC, CANADA. CRODAMOL SE (REFINED DIETHYL SEBACATE) AS MANUFACTURED IN SHIGA, JAPAN. CRODAMOL DA (DIISOPROPYL ADIPATE) AS MANUFACTURED IN SHIGA, JAPAN. LEVONORGESTREL AS MANUFACTURED IN VARESE, ITALY. NONPAREIL-103 AS MANUFACTURED IN HAMAMATSU CITY, JAPAN. D5AA (3-OXO-4-AZA-ANDROSTENE-17 -CARBOXYLIC ACID) AS MANUFACTURED IN VISP, SWITZERLAND.

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4Q2012EXCEL DMF# 16699 16700 16701 16702 I 16703 I 16704 16705 A 16706 16707 16708 16709 I 16710 16711 16712 16713 16714 16715 A 16716 A 16717 16718 16719 16720 A 16721 16722 16723 16724 I 16725 I 16726 I 16727 16728 I 16729 16730 A A III II 7/28/2003 7/29/2003 REXAM HEALTHCARE OFFRANVILLE SAS UNIQUE CHEMICALS A III II 7/25/2003 7/23/2003 CRESTANI SRL SPRING WIND HERBS INC III 7/9/2003 HUHTAMAKI RONSBERG II 7/29/2003 AVANTI POLAR LIPIDS INC I A I IV II II IV 7/22/2003 7/24/2003 7/28/2003 7/21/2003 FLAVORMATIC INDUSTRIES INC TEVA PHARMACEUTICAL INDUSTRIES LTD DAIICHI SANKYO CO LTD SYMRISE INC I A I II II IV IV 7/21/2003 7/18/2003 7/16/2003 7/24/2003 FABBRICA ITALIANA SINTETICI SPA GMT FINE CHEMCALS SA FONA INTERNATIONAL INC ROBERTET FLAVORS INC III 7/22/2003 APTAR RADOLFZELLGMBH A I A A I II III III II IV II 7/15/2003 7/10/2003 7/16/2003 7/18/2003 7/18/2003 7/23/2003 A C A II II II II 7/14/2003 7/7/2003 7/16/2003 7/15/2003 ERIOCHEM SA IPCA LABORATORIES LTD MYLAN LABORATORIES LTD INSTITUTE OF DRUG TECHNOLOGY AUSTRALIA LTD HIKAL LTD RICON COLORS TUBEX TUBENFABRIK WOLFSBERG GMBH USV LIMITED PADDOCK LABORATORIES INC DEGUSSA LTD I IV IV 7/11/2003 7/10/2003 II 7/14/2003 DISHMAN PHARMACEUTICALS AND CHEMICAL PVT LTD FLAVORMATIC INDUSTRIES INC FLAVORMATIC INDUSTRIES INC STATUS Type SUBMIT DATE A A A II II II V 7/11/2003 7/11/2003 7/8/2003 6/26/2003 HOLDER BASF PHARMA EVIONNAZ SA FERMION OY TEVA PHARMACEUTICAL INDUSTRIES LTD MERCK RESEARCH LABORATORIES SUBJECT LEVONORDEFRIN AS MANUFACTURED IN EVIONNAZ, SWITZERLAND. CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN HANKO, FINLAND. PACLITAXEL AS MANUFACTURED IN OPAVA, CZECH REPUBLIC. L-829165 POSITRON EMISSION TOMOGRAPHY (PET) TRACER SAFETY AND PHARMACOLOGY REFERENCE DATA (ESUB) EPROSARTAN MESYLATE AS MANUFACTURED IN AHMEDABAD, INDIA.

4Q2012

N&A GRAPE TYPE FLAVOR #909-510 AS MANUFACTURED IN WAPPINGERS FALLS, NY. N&A BUBBLE GUM TYPE FLAVOR #909-487 AS MANUFACTURED IN WAPPINGERS FALLS, NY. VINORELBINE TARTRATE, USP AS MANUFACTURED IN ENTRE RIOS, ARGENTINA HYDROCHLOROTHIAZIDE AS MANUFACTURED IN MAHARASHTRA, INDIA. CLARITHROMYCIN USP (CXP) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CARBOPLATIN AS MANUFACTURED IN VICTORIA, AUSTRALIA. ONDANSETRON HYDROCHLORIDE AS MANUFACTURED IN BANGALORE, INDIA. WHITE CPP-W368-8 POLYPROPYLENE AS MANUFACTURED IN WEST CHICAGO, IL. COLLAPSIBLE ALUMINIUM TUBES AS MANUFACTURED IN ST. STEFAN, AUSTRIA. GLIMEPIRIDE AS MANUFACTURED IN MAHARASHTRA, INDIA. DERMABASE(TM) CREAM AS MANUFACTURED IN MINNEAPOLIS, MN. INSOLUBLE PRUSSIAN BLUE [IRON (III) HEXACYANOFERRATE (II)] AS MANUFACTURED IN MANCHESTER, UNITED KINGDOM. MULTIDOSE DISPENSING SYSTEM FOR UNPRESERVED PRODUCTS AS MANUFACTURED IN RADOLFZELL AND EIGELTINGEN, GERMANY. CITALOPRAM AS MANUFACTURED IN VICENZA, ITALY. LEUCOVORIN CALCIUM, USP AS MANUFACTURED IN COUVET, SWITZERLAND. #913.006, NAT & ART SPEARMINT FLAVOR AS MANUFACTURED IN CAROL STREAM, IL. ARTIFICIAL SPRAY DRIED SUGAR TASTE FLAVOR NV-24,013 AS MANUFACTURED IN PISCATAWAY, NJ. N&A APPLE TYPE FLAVOR #909-359 AS MANUFACTURED IN WAPPINGERS FALLS, NY. CILOSTAZOL AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. DX-619 DRUG SUBSTANCE AS MANUFACTURED IN TOKYO, JAPAN. ARTIFICIAL APPLE FLAVOR 9/70X834 (609041) AND ARTIFICIAL WATERMELON FLAVOR 9/710233 (843657) AS MANUFACTURED IN TETERBORO, TOTOWA, BRANCHBURG, NJ. 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (POPC) AS MANUFACTURED IN ALABASTER, AL. TUBE LAMINATES 1327 F, 1337 F, 1338 F AND 2328 F AS MANUFACTURED IN RONSBERG, FEDERAL REPUBLIC OF GERMANY AND RIO GRANDE DO NORTE, BRAZIL. GLASS AMPOULES AS MANUFACTURED IN VICENZA, ITALY. ARNEBIA INDIGO JADE AND PEARL (AIJP) OINTMENT AS MANUFACTURED IN ALBUQUERQUE, NM. PILL JARS SETS AS MANUFACTURED IN OFFRANVILLE, FRANCE. NIFEDIPINE USP AS MANUFACTURED IN GUJARAT, INDIA.

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4Q2012EXCEL DMF# 16731 I 16732 16733 I 16734 16735 16736 16737 16738 16739 16740 16741 I 16742 A 16743 III 7/30/2003 II 7/25/2003 A A A A I I A II II II II II V III IV 7/31/2003 7/25/2003 7/28/2003 7/31/2003 7/22/2003 6/27/2003 7/31/2003 7/31/2003 A II II 8/1/2003 7/31/2003 NORAMCO INC MERCK SHARP AND DOHME RESEARCH LABORATORIES DIV MERCK AND CO INC INTERQUIM SA DE CV FARMHISPANIA SA MEDICHEM SA CU CHEMIE UETIKON GMBH MICRON TECHNOLOGIES INC GW PHARMA LTD TRUDELL MEDICAL INTERNATIONAL OXYCODONE BASE DRUG SUBSTANCE AS MANUFACTURED IN ATHENS, GA. L-000825058 AS MANUFACTURED IN RAHWAY, NJ. STATUS Type SUBMIT DATE III 7/10/2003 HOLDER VALOIS SAS SUBJECT

4Q2012

VALOIS BUTYL 540 SERIES ELASTOMER AS MANUFACTURED IN VAL DE REUIL, FRANCE.

TIAMULIN HYDROGEN FUMARATE AS MANUFACTURED IN EDO. DE MEXICO, MEXICO. QUINAPRIL HYDROCHLORIDE (FH-106) AS MANUFACTURED IN BARCELONA, SPAIN. GLIMEPIRIDE AS MANUFACTURED IN GIRONA, SPAIN. S-KETAMINE HYDROCHLORIDE AS MANUFACTURED IN LAHR, GERMANY. CONTRACT MICRONIZATION FACILITY IN EXTON, PA. CANNABIS BASED MEDICINE AS MANUFACTURED IN WREXHAM, UNITED KINGDOM. TOP MOUNT DOSE INDICATOR AS MANUFACTURED IN ONTARIO, CANADA.

A 16744 I 16745 16746 16747 16748 16749 I 16750 16751 16752 16753 A 16754 16755 16756 16757 16758 16759 16760 16761 A 16762 A III 8/13/2003 I A A A I A A II II IV IV II II II III 8/11/2003 8/7/2003 7/31/2003 7/31/2003 8/11/2003 8/13/2003 8/13/2003 8/13/2003 A I I II II II II 8/8/2003 8/8/2003 8/8/2003 8/11/2003 A I A I II II II II II 7/31/2003 8/7/2003 8/4/2003 8/8/2003 8/8/2003 II 8/5/2003

LAUREATE BIOPHARMACEUTICAL SERVICES ARTIFICIAL GRAPE FLAVOR #1749 AS MANUFACTURED IN KALAMAZOO, MI. INC FERRO PFANSTIEHL ADIPIC ACID BIS (N-HYDROXYSUCCINIMIDE) ESTER (A-163-1) AS MANUFACTURED IN WAUKEGAN, IL. SILGAN PLASTICS CORP PLASTICS BOTTLES, JARS AND CONTAINERS MANUFACTURED BY THE INJECTION BLOWMOLDING PROCESS AS MANUFACTURED IN DEEP RIVER, CT; FLORA, IL; LIGONIER, IN; PENN YAN, NY; PORT CLINTON, OH; TRIADELPHIA, WV AND, QUEBEC AND ONTARIO, CANADA. SANOFI CHIMIE (A SUBSIDIARY OF SANOFIAVENTIS) FERRO PFANSTIEHL ALEMBIC LTD DR REDDYS LABORATORIES LTD OPOCRIN SPA ROCHE DIAGNOSTICS GMBH CHANGZHOU PHARMACEUTICAL FACTORY TEVA PHARMACEUTICAL INDUSTRIES LTD PHF SA CIPLA LTD KYORIN PHARMACEUTICAL CO LTD NYCOMED AUSTRIA GMBH NATIONAL PRODUCTS CO NATIONAL PRODUCTS CO COGNIS CORP LANXESS CORP BACHEM AMERICAS INC BALL AEROCAN UK LTD COMAR INC LEVOMEPROMAZINE MALEATE AS MANUFACTURED IN VITRY-SUR-SEINE, FRANCE. 2-DEOXY-D-GLUCOSE (D-101-1) AS MANUFACTURED IN WAUKEGAN, IL. CLARITHROMYCIN AS MANUFACTURED IN GUJARAT, INDIA. RABEPRAZOLE SODIUM (FORM Y) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ENOXAPARIN SODIUM AS MANUFACTURED IN CORLO DI FORMIGINE, ITALY. BM 17.0744 NA (K-111) AS MANUFACTURED IN MANNHEIM, FEDERAL REPUBLIC OF GERMANY. HYDROCHLOROTHIAZIDE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA. AZTREONAM AS MANUFACTURED IN MEXICO, MO AND PETAH TIQVA, ISRAEL. SERTRALINE HYDROCHLORIDE AS MANUFACTURED IN QUEBEC, CANADA. OFLOXACIN USP (ESUB) AS MANUFACTURED IN BANGALORE, MAHARASHTRA, MUMBAI AND GOA, INDIA. KRP-297 AS MANUFACTURED IN NAGANO AND AKITA, JAPAN. LORNOXICAM AS MANUFACTURED IN LINZ, AUSTRIA. APPLE FLAVOR #17178 AS MANUFACTURED IN KALAMAZOO, MI. WATERMELON FLAVOR #1709 AS MANUFACTURED IN KALAMAZOO, MI. DERMAZ(TM) 95 AZELAIC ACID AS MANUFACTURED IN CINCINNATI, OH. PREVENTOL SB AS MANUFACTURED IN LEVERKUSEN, GERMAY. OCTREOTIDE ACETATE AS MANUFACTURED IN TORRANCE, CA. ONE PIECE ALUMINIUM AEROSOL CANS AS MANUFACTURED IN WILTSHIRE, UNITED KINGDOM. PLASTIC CLOSURES (ESUB) AS MANUFACTURED IN BUENA, NJ.

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4Q2012EXCEL DMF# 16763 I 16764 16765 16766 I 16767 A 16768 16769 16770 A 16771 16772 16773 16774 A 16775 A 16776 16777 16778 16779 I 16780 16781 16782 16783 16784 16785 16786 16787 16788 16789 A 16790 16791 16792 I 16793 A 16794 16795 A A II II 8/28/2003 8/15/2003 WOCKHARDT LTD BAYER PHARMA AG II 8/28/2003 WOCKHARDT LTD I A II II III 8/22/2003 8/26/2003 8/22/2003 N N N N A A A A I II II II II II II 8/20/2003 8/20/2003 9/4/2003 8/27/2003 8/26/2003 8/25/2003 NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER CHEMAGIS LTD AMINO CHEMICALS LTD CADILA PHARMACEUTICALS LTD GLENMARK GENERICS LTD WOCKHARDT LTD TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN BEER SHEVA, ISRAEL. ZALEPLON AS MANUFACTURED IN MARSA, MALTA. ONDANSETRON HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA. I I A II II III III 8/22/2003 8/18/2003 8/19/2003 8/14/2003 CONTIPRO C A.S. TAKASAGO INTERNATIONAL CORP POLYONE CORP CLARIANT (CANADA) INC III 8/7/2003 COLORTECH INC A A A II II III III 8/15/2003 8/19/2003 8/13/2003 8/14/2003 A A II II V 8/18/2003 8/18/2003 12/4/2003 FORMOSA LABORATORIES INC FORMOSA LABORATORIES INC BOEHRINGER INGELHEIM RCV GMBH AND CO KG JOHNSON MATTHEY PHARMA SERVICES NOVARTIS PHARMA AG POLYONE CORP SILGAN PLASTICS CORP II 8/14/2003 DOTTIKON EXCLUSIVE SYNTHESIS AG A I II IV II 8/18/2003 8/13/2003 8/15/2003 CIPLA LTD GUJARAT FLUOROCHEMICALS LTD AVANTI POLAR LIPIDS INC STATUS Type SUBMIT DATE II 8/15/2003 HOLDER PARTICLE DYNAMICS INC SUBJECT DESTAB(TM) CALCIUM CARBONATE 95 MD ULTRA 250 AS MANUFACTURED IN LITCHFIELD, MN. RABEPRAZOLE SODIUM (ESUB) AS MANUFACTURED IN BANGALORE, INDIA. PROPELLANT GRADE CFC (S) AS MANUFACTURED IN GUJARAT STATE, INDIA.

4Q2012

N-HEXANOYL-D-ERYTHRO-SPHINGOSINE (C6 CERAMIDE) AS MANUFACTURED IN ALABASTER, AL. PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN DOTTIKON, SWITZERLAND. APRACLONIDINE HYDROCHLORIDE AS MANUFACTURED IN TAOYUAN, TAIWAN. CAPSAICIN AS MANUFACTURED IN TAOYUAN, TAIWAN. CONTRACT MANUFACTURING FACILITY IN VIENNA, AUSTRIA. CLEVIDIPINE AS MANUFACTURED IN DEVENS AND NORTH ANDOVER, MA. NAFTIFINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN BASEL, SWITZERLAND PRODUCT NO. CC00012714WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL. BOTTLES, JARS AND CONTAINERS BY THE STRETCH-BLOW-MOLDING PROCESS AS MANUFACTURED IN ANAHEIM, CA; PENN YAN, NY; RICHMOND, VA; LANGHORNE, PA; MONROE, GA; TRIADELPHIA, WV AND; QUEBEC AND ONTARIO, CANADA. 11002-18 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN. SODIUM HYALURONATE AS MANUFACTURED IN DOLNI DOBROUC, CZECH REPUBLIC. 4AA AS MANUFACTURED IN SHIZUOKA AND HYOGO PREFECTURE, JAPAN. PRODUCT NO. CC00017553WE AS MANUFACTURED IN GLENDALE, AZ. BLUE CLARIANT MASTERBATCH 04PPP-7351 AS MANUFACTURED IN ONTARIO AND QUEBEC, CANADA.

AMIODARONE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT STATE, INDIA. CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN MAHARASHTRA STATE INDIA.

ZHEJIANG CHIRAL MEDICINE CHEMICALS CO ETODOLAC AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. LTD LONZA LTD EPROSARTAN MESYLATE (ROUTE F) AS MANUFACTURED IN VISP, SWITZERLAND. NEULAND LABORATORIES LTD MAC CLOSURES INC LEVOFLOXACIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA. RECLOSEABLE CONTINUOUS THREADED JIGGER STYLE CLOSURES AS MANUFACTURED IN QUEBEC, CANADA. PIOGLITAZONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA STATE, INDIA. CEFTAZIDIME FOR INJECTION AS MANUFACTURED IN GUJARAT STATE, INDIA. TESTOSTERONE UNDECANOATE AS MANUFACTURED IN MEXICO.

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4Q2012EXCEL DMF# 16796 16797 16798 16799 A 16800 16801 16802 16803 16804 I 16805 I 16806 I 16807 C 16808 16809 A 16810 16811 A 16812 16813 A 16814 16815 A 16816 16817 16818 16819 16820 16821 16822 16823 16824 16825 A 16826 16827 16828 A A I III II III 9/5/2003 9/8/2003 9/5/2003 RICHLAND GLASS NOVUS FINE CHEMICALS LLC TRESPAPHAN GMBH A A A A I A A A A III II II II III IV IV IV II II 9/2/2003 9/3/2003 8/26/2003 9/2/2003 9/9/2003 9/2/2003 9/2/2003 9/2/2003 9/5/2003 9/9/2003 A III II 9/5/2003 8/28/2003 APTAR FRANCE SAS ZHEJIANG HISOAR PHARMACEUTICAL CO LTD ASHLAND INC DIVIS LABORATORIES LTD KUMAR ORGANIC PRODUCTS LIMITED TRANSO PHARM PRODUKTIONS GMBH BOMATIC INC BASF SE COGNIS GMBH BASF SE BIOFAC AS AVON ORGANICS LTD A II II 8/28/2003 9/3/2003 CAMBRIDGE MAJOR LABS INC LONZA BRAINE SA I II III 8/20/2003 8/12/2003 XELLIA PHARMACEUTICALS APS ADVANCED SCIENTIFICS INC A II II 8/29/2003 8/15/2003 II 8/27/2003 II 9/2/2003 II 9/2/2003 I A I A III II II II III 8/29/2003 8/8/2003 8/27/2003 9/3/2003 9/2/2003 BOREALIS A/S CYALUME SPECIALTY PRODUCTS INC FDC LTD PRODOTTI CHIMICI E ALIMENTARI SPA WINPAK TECHNOLOGIES INC STATUS Type SUBMIT DATE A I I III III II II 8/19/2003 8/13/2003 8/27/2003 8/29/2003 HOLDER APTAR FRANCE SAS PLASPAK CLOSURES PTY TD ALCHYMARS SPA GE HEALTHCARE 38MM CLOSURE AS MANUFACTURED IN NSW, AUSTRALIA. ALENDRONIC ACID MONOHYDRATE AS MANUFACTURED IN MILANO, ITALY. SUBJECT

4Q2012

KVICK(TM) ULTRAFILTRATION CASSETTES AS MANUFACTURED IN WESTBOROUGH, MA. PACKAGING MATERIAL MA 9230 AS MANUFACTURED IN STATHELLE, NORWAY. METHENAMINE HIPPURATE, USP AS MANUFACTURED IN BOUND BROOK, NJ. KETOCONAZOLE AS MANUFACTURED IN MAHARASHTRA STATE, INDIA. URSODIOL USP XXVI AS MANUFACTURED IN BASSALUZZO, ITALY. 32.1 GSM 23.0UM POLYESTER 10.15.92/ 0.03 GSM PRIMER 10-QQ-1/ 16.0 GSM PE 5050/ 48.6 GSM 18.0 UM ALUMINUM FOIL/ 24.0 GSM PE NUCREL 3990SB AS MANUFACTURED IN ONTARIO, CANADA.

ZHEJIANG CHENG YI PHARMACEUTICAL CO MERCAPTOPURINE USP AS MANUFACTURED IN ZHEJIANG, P.R. CHINA. LTD ZHEJIANG CHENG YI PHARMACEUTICAL CO AZATHIOPRINE USP AS MANUFACTURED IN ZHEJIANG, P.R. CHINA. LTD ZHEJIANG HISUN PHARMACEUTICAL CO LTD FLUDARABINE PHOSPHATE, NON-STERILE BULK DRUG AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA. NOF CORP DIOLEOYL PHOSPHATIDYLCHOLINE (DOPC) AS MANUFACTURED IN HYOGO, JAPAN. BAYER PHARMA AG TESTOSTERONE UNDECANOATE 1000 MG I.M. AS MANUFACTURED IN JENA AND WEIMAR, GERMANY. TOBRAMYCIN SULFATE, USP STERILE AS MANUFACTUREED IN COPENHAGE, DENMARK AUTOCLAVABLE POLYPROPYLENE DRUG DELIVERY BAG AS MANUFACTURED IN MILLERSBURG, PA. FP-043 AS MANUFACTURED IN GERMANTOWN, WI. DESMOPRESSIN (ACETATE) (CODE SF278) (ESUB) AS MANUFACTURED IN BRAINEL'ALLEUD, BELGIUM. APTAR VP7 PUMPS AS MANUFACTURED IN LE VAUDREUIL, FRANCE. CLINDAMYCIN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA. AROSET 3512 AS MANUFACTURED IN DUBLIN, OH. SULPHAZINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. TRICLOSAN AS MANUFACTURED IN BANGALORE, INDIA. DIAZOXIDE AS MANUFACTURED IN BEXBACH, GERMANY. D-RG 1001 AS MANUFACTURED IN ONTARIO, CANADA. Kollicream(R) CI AS MANUFACTURED IN DUESSELDORF, GERMANY. DEHYMULS HRE 7 AS MANUFACTURED IN DUESSELDORF, GEMANY. Kolliphor(R) CS A AS MANUFACTURED IN DUESSELDORF, GERMANY. THROMBIN POWDER AS MANUFACTURED IN KASTRUP, DENMARK. PSEUDOEPHEDRINE SULFATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. GLASS VIALS / AMPOULES AS MANUFACTURED IN VINELAND, NJ. METFORMIN HYDROCHLORIDE AS MANUFACTURED IN CARLSTADT, NJ. TRESPAPHAN NNA AS MANUFACTURED IN NEUNKIRCHEN, GERMANY.

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4Q2012EXCEL DMF# 16829 16830 16831 16832 I 16833 16834 16835 16836 16837 16838 A 16839 16840 I 16841 16842 16843 16844 16845 16846 I 16847 A 16848 I 16849 16850 16851 16852 16853 16854 A 16855 16856 16857 16858 16859 16860 16861 16862 I 16863 A II 9/24/2003 TARO PHARMACEUTICAL INDUSTRIES LTD I A A I I I A II II II II II II II III 9/16/2003 9/22/2003 9/12/2003 8/27/2003 8/26/2003 8/26/2003 9/23/2003 9/8/2003 GENERAL CHEMICAL CORP CHEMAGIS LTD LUPIN LTD GENERAL CHEMICAL CORP GENERAL CHEMICAL CORP GENERAL CHEMICAL CORP STERLING S P A CLARIANT (CANADA) INC REHYDRAGEL LG AS MANUFACTURED IN BERKELEY HEIGHTS, NJ. HALOBETASOL PROPIONATE AS MANUFACTURED IN BEER SHEVA, ISRAEL. A A A A A II II II IV III IV 9/16/2003 9/19/2003 9/17/2003 9/22/2003 9/12/2003 9/23/2003 II 9/17/2003 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA EUTICALS SPA AUROBINDO PHARMA LTD ROCHE DIAGNOSTICS GMBH FLAVORS NORTH AMERICA INC BASELL USA INC ROQUETTE FRERES II 9/18/2003 A I I A A II II II III II II 9/15/2003 9/15/2003 9/15/2003 9/16/2003 10/10/2003 9/16/2003 YUHAN CHEMICAL INC ALBANY MOLECULAR RESEARCH INC IRVINE SCIENTIFIC SALES CO BAXA CORP OLON SPA SHANGHAI PHARMACEUTICAL GROUP CO LTD SANDOZ INDUSTRIAL PRODUCTS GMBH A II III 9/9/2003 9/8/2003 A A I I I II III II II II II 9/12/2003 9/10/2003 9/11/2003 9/12/2003 9/15/2003 9/5/2003 ASTELLAS PHARMA INC TECH GROUP EUROPE PCAS AVECIA BIOTECHNOLOGY INC BIOTIKA SA CHONGQING CARE LIFE PHARMACEUTICAL CO LTD WOCKHARDT LTD CLARIANT (CANADA) INC STATUS Type SUBMIT DATE I A A II II III III 9/10/2003 9/9/2003 9/12/2003 9/12/2003 HOLDER MITSUBISHI PHARMA CORP PCAS BD PHARMACEUTICAL SYSTEMS DIV MITSUI CHEMICALS AMERICA INC SUBJECT MCC-977 DRUG SUBSTANCE AS MANUFACTURED IN IBARAKI-KEN, JAPAN.

4Q2012

CYCLOPIROX OLAMINE AS MANUFACTURED IN LIMAY, FRANCE AND TURKU, FINLAND. BDPS NEEDLE SHIELD AS MANUFACTURED IN BAD RAGAZ, SWITZERLAND. ADMER(R) QF551E AS MANUFACTURED IN ER KERKRADE, THE NETHERLANDS AND AHRENSBURG, GERMANY. TACROLIMUS (FK506) DRUG SUBSTANCE AS MANUFACTURED IN TOYAMA, JAPAN. INTRANASAL SINGLE LEVER OUTER DEVICE AS MANUFACTURED IN DUBLIN, IRELAND. (R)-OXYBUTYNIN BASE AS MANUFACTURED IN LIMAY, FRANCE. OLIGONUCLEOTIDE APO AS MANUFACTURED IN MILFORD, MA. PENICILLIN G POTASSIUM AS MANUFACTURED IN SLOVENSKA L'UPCA, SLOVAKIA. GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN CHONGQING, CHINA. CEFOTAXIME SODIUM (STERILE) AS MANUFACTURED IN GUJARAT STATE, INDIA ORANGE CLARIANT MASTERBATCH 09PPP-191 AS MANUFACTURED IN ONTARIO AND QUEBEC, CANADA. PIPERACILLIN MONOHYDRATE AS MANUFACTURED IN KYUNGGI-DO, KOREA. CITC-DTPA AS MANUFACTURED IN ALBANY, NY. IS CHO-CD(TM) (P) CATALOG #94111 AS MANUFACTURED IN SANTA ANA, CA. ORAL DISPENSER ACCESSORIES AS MANUFACTURED IN ENGLEWOOD, CO. TENIPOSIDE AS MANUFACTURED IN RODANO, ITALY. GRISEOFULVIN USP MICROCRYSTALLINE AS MANUFACTURED IN SHANGHAI, CHINA. PENICILLIN G POTASSIUM STERILE AND PENICILLIN G POTASSIUM STERILE, BUFFERED AS MANUFACTURED IN FRANKFURT AM MAIN, GERMANY. SERTRALINE HYDROCHLORIDE FORM II AS MANUFACTURED IN CAMPOVERDE DI APRILIA (LT), ITALY. OXANDROLONE USP AS MANUFACTURED IN ROZZANO (MI), ITALY. CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN MEDAK DIST., A.P., INDIA. TORASEMIDE AS MANUFACTURED IN MANNHEIM, GERMANY. 913.004 NOR-CAP NATURAL & ARTIFICIAL SPEARMINT FLAVOR RESIN: PD626 AS MANUFACTURED IN GAHANNA, OH. SODIUM STARCH GLYCOLATE USP/NF AS MANUFACTURED IN LESTREM CEDEX, FRANCE.

BENAZEPRIL HYDROCHLORIDE AS MANUFACTURED IN MADHYA PRADESH, INDIA. REHYDRAGEL CG AS MANUFACTURED IN BERKELEY HEIGHTS, NJ. REHYDRAGEL HPA AS MANUFACTURED IN BERKELEY HEIGHTS, NJ. REHYDRAGEL LV AS MANUFACTURED IN BERKELEY HEIGHTS, NJ. HALOBETASOL PROPIONATE AS MANUFACTURED IN PERUGIA, ITALY. BLUE CLARIANT MASTERBATCH 04EHD-1677 AS MANUFACTURED IN ONTARIO AND QUEBEC, CANADA ESMOLOL HYDROCHLORIDE AS MANUFACTURED IN HAIFA BAY, ISRAEL.

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4Q2012EXCEL DMF# 16864 I 16865 16866 A 16867 I 16868 16869 I 16870 A 16871 A 16872 16873 A 16874 16875 I 16876 16877 A 16878 I 16879 16880 16881 16882 16883 16884 16885 16886 16887 16888 16889 I 16890 16891 I 16892 16893 16894 A I C V III II 9/3/2003 9/15/2003 10/5/2003 A II II 10/1/2003 9/30/2003 CHEMWERTH INC A A A A A A A A I I II III III III III III V IV II IV III 9/23/2003 9/29/2003 9/29/2003 9/29/2003 9/29/2003 9/29/2003 10/6/2003 9/26/2003 10/2/2003 9/30/2003 9/30/2003 NEOMPS INC DYNIC USA CORP DYNIC USA CORP DYNIC USA CORP DYNIC USA DYNIC USA BASF CORP BASF SE LEK PHARMACEUTICALS DD PHARMACEUTICAL COATINGS PVT LTD POLFA BOLESLAWIEC III 9/19/2003 EASTMAN CHEMICAL CO A II II 10/2/2003 9/30/2003 GLENMARK GENERICS LTD MILLIPORE CORP I II IV 9/29/2003 9/30/2003 SAFC PHARMA SYMRISE INC A II II 9/26/2003 9/25/2003 CAMBREX CHARLES CITY INC SOURCETECH QUIMICA LTDA II 9/29/2003 CRYSTAL PHARMA SAU III 9/30/2003 TEKNI PLEX EUROPE NV I II IV 9/23/2003 9/19/2003 EVESTRA INC KERRY CANADA INC III 9/25/2003 NATIONAL STARCH CHEMICAL CO A III III 9/22/2003 7/16/2003 FLEXTRUS AB CAPORIZZI AND FRIZZI STATUS Type SUBMIT DATE II 9/22/2003 HOLDER CARDINAL HEALTH SUBJECT

4Q2012

TAZAROTENE 1.5 MG AND 4.5 MG CAPSULES AS MANUFACTURED IN ST. PETERSBURG, FL TRANSOFOIL EL-OPET/PE LAMINATE AS MANUFACTURED IN LUND, SWEDEN KNACKPACK/0305 GREY AND RED AS MANUFACTURED IN KRANJ, SLOVENIA FOR CAPORIZZI & FRIZZI PRODUCER(R) 33-9010 AS MANUFACTURED IN BERKLEY, CA; ENOREE,SC AND HAZELTON, PA CDB-4124 DRUG SUBSTANCE AS MANUFACTURED IN SAN ANTONIO, TX. GRAPE SODA ARTIFICIAL FLAVOR MC006124 AS MANUFACTURED IN GRANBY, CANADA ABLEX 501, ABLEX 503, AND ABLEX 701 AS MANUFACTURED IN EREMBODEGEM, BELGIUM. ALCLOMETASONE DIPROPIONATE AS MANUFACTURED IN BOECILLO (VALLADOLID), SPAIN. FENTANYL AS MANUFACTURED IN NORTH BRUNSWICK, NJ. PILOCARPINE HYDROCHLORIDE AS MANUFACTURED IN PINDAMONHANGABA - SP, BRAZIL. CHO MEDIUM-ANIMAL COMPONENT-FREE AS MANUFACTURED IN ST. LOUIS, MO. 823992 NATURAL & ARTIFICIAL CAPPUCCINO TYPE FLAVOR CONCENTRATE AS MANUFACTURED IN TETERBORO, TOTOWA AND BRANCHBURG, NJ. CILOSTAZOL AS MANUFACTURED IN GUJARAT STATE, INDIA. MILLIPORE CORPORATION EXPRESS(R) MEMBRANE AND FILTERS AS MANUFACTURED IN BEDFORD, MA AND JEFFREY, NH. EASTAPAK(R) AND EASTAR(R) POLYMER PRODUCTION AS MANUFACTURED IN KINGSPORT, TN. SYNTHETIC PEPTIDE MPS-178 AS MANUFACTURED IN SAN DIEGO, CA. HL30 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR. HL32 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR. HL45 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR. L345 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR. S345 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR. KOLLICOAT (R) IR TOXICOLOGY STUDIES IN LUDWIGSHAFEN, GERMANY KOLLICOAT (R) IR AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY AMLODIPINE BESYLATE AS MANUFACTURED IN KOLODVORSKA, SLOVENIA. TABCOAT TC* AS MANUFACTURED IN NAVI MUMBAI, INDIA. ALUMINIUM TUBES, CANS AND CLOSURE-SYSTEMS AS MANUFACTURED IN BOLESLAWIEC, POLAND. SIROLIMUS AS MANUFACTURED IN FUJIAN PROVINCE, CHINA FOR CHEMWERTH INC

CHONGQING UNITED PHARMACEUTICAL CO PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, P.R. CHINA. LTD ALTHEA TECHNOLOGIES INC ASEPTIC FORMULATION, FILL, AND FINISH FACILITY IN SAN DIEGO, CA. ERIE MOLDED PLASTICS INC DIVIS LABORATORIES LTD LID FOR DEODORANT AS MANUFACTURED IN ERIE, PA. LEVETIRACETAM AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

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4Q2012EXCEL DMF# 16895 A 16896 16897 16898 I 16899 A 16900 16901 16902 16903 16904 16905 16906 A 16907 16908 16909 16910 A 16911 16912 A 16913 A 16914 I 16915 16916 16917 16918 A 16919 A 16920 A 16921 16922 16923 16924 A A A A II II II III 10/20/2003 10/21/2003 3/11/2005 10/3/2003 JUZEN CHEMICAL CORP CIPLA LTD HOSPIRA BOULDER INC INVIBIO LTD ECABET SODIUM AS MANUFACTURED IN TOYAMA PREFECTURE, JAPAN. III 10/22/2003 II 10/21/2003 CHONGQING CARE LIFE PHARMACEUTICAL CO LTD VINS PLASTICS LTD A A I II II II II 10/20/2003 10/21/2003 10/9/2003 10/19/2003 GUFIC BIOSCIENCES LTD CIPLA LTD REHEIS INTERMEDIATES DIVIS LABORATORIES LTD KETOCONAZOLE USP AS MANUFACTURED IN GUJARAT STATE, INDIA. CARBOPLATIN (ESUB) AS MANUFACTURED IN BANGALORE, INDIA. REHYDRAPHOS AS MANUFACTURED IN BERKELEY HEIGHTS, NJ III 10/10/2003 II 10/15/2003 A II II 9/13/2003 10/15/2003 CADILA PHARMACEUTICALS LTD YANTAI DONGCHENG BIOCHEMICALS CO LTD YANTAI DONGCHENG BIOCHEMICALS CO LTD AMPACET CORP I A A II II IV II 10/15/2003 10/14/2003 10/7/2003 10/16/2003 I I A A A I II II II II II II II 10/13/2003 10/13/2003 10/10/2003 10/20/2003 10/16/2003 10/16/2003 10/15/2003 II 10/8/2003 RECORDATI INDUSTRIA CHIMICAE FARMACEUTICA SPA ESTEVE QUIMICA SA ERCROS INDUSTRIAL SA FYSE DR REDDYS LABORATORIES LTD QUIMICA SINTETICA SA PIRAMAL HEALTHCARE LTD PIRAMAL HEALTHCARE LTD NORTH CHINA PHARMACEUTICAL VICTOR CO LTD NV ORGANON RANBAXY LABORATORIES LTD DOW CORNING CORP LABORATORIOS HAYMANN SA A I II III II 10/6/2003 5/22/2003 10/10/2003 FERRO PFANSTIEHL INC STE PACKAGIN DEVELOPMENT SL ABBOTT LABORATORIES STATUS Type SUBMIT DATE IV 10/6/2003 HOLDER FIRMENICH INC SUBJECT

4Q2012

NATURAL & ARTIFICIAL ORANGE FLAVOR 501071 AP0551 AS MANUFACTURED IN PLAINSBORO, NJ. CYTARABINE USP AS MANUFACTURED IN WAUKEGAN, IL. MRI PACKAGING SYSTEM AS MANUFACTURED IN TARRAGONA, SPAIN. FENOFIBRATE SPRAY GRANULATION INTERMEDIATE AS MANUFACTURED IN CORK, IRELAND. FOSPHENYTOIN SODIUM API AS MANUFACTURED IN LATINA, ITALY. RAMIPRIL AS MANUFACTURED IN BARCELONA AND CELRA, SPAIN. LOVASTATIN (TECHNICAL GRADE) AS MANUFACTURED IN MADRID, SPAIN. RISPERIDONE FORM-1 AS MANUFACTURED IN ANDHRA PRADESH, INDIA. SUMATRIPTAN AS MANUFACTURED IN MADRID, SPAIN LEVOBUNOLOL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ITRACONAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CYANOCOBALAMIN, USP (VITAMIN B-12) AS MANUFACTURED IN HEBEI, CHINA. ANDROSTANOLONE AS MANUFACTURED IN OSS, THE NETHERLANDS. LEVOFLOXACIN AS MANUFACTURED IN PUNJAB, INDIA. DOW CORNING(R) EMULSIFIER 10 AS MANUFACTURED IN HEMLOCK, MI. NICOTINE POLACRILEX USP (ESUB), 20% AS MANUFACTURED IN MONTEVIDEO, URUGUAY. AMLODIPINE BESYLATE ( ESUB) AS MANUFACTURED IN GUJARAT, INDIA. CHONDROITIN SULFATE CALCIUM, NON-STERILE BULK DRUG AS MANUFACTURED IN SHANDONG PROVINCE, CHINA. CHONDROITIN SULFATE SODIUM, NON-STERILE BULK DRUG AS MANUFACTURED IN SHANDONG PROVINCE, CHINA. 110021-A WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA.

PHENYLEPHRINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. VENLAFAXINE HYDROCHLORIDE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN CHONGQING, CHINA. FLEXIBLE PACKAGING MATERIAL IN ROLL FORM FOR PACKAGING OF PHARMACEUTICAL OINTMENTS AND CREAMS AS MANUFACTURED IN ONTARIO, CANADA.

LEVOFLOXACIN HEMIHYDRATE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA. 10-DEACETYL BACCATIN III AS MANUFACTURED IN BOULDER, CO. PEEK-OPTIMA AND PEEK GB GRADES OF POLYETHERETHERKETONE POLYMER AS MANUFACTURED IN LANCASHIRE, UNITED KINGDOM.

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4Q2012EXCEL DMF# 16925 I 16926 16927 I 16928 16929 16930 16931 A 16932 16933 I 16934 I 16935 16936 16937 I 16938 16939 16940 I 16941 A 16942 16943 16944 16945 A 16946 16947 16948 I 16949 16950 16951 A 16952 16953 16954 16955 A A A A II II III III 11/11/2003 11/13/2003 10/16/2003 11/10/2003 A C II II II 11/10/2003 11/14/2003 11/3/2003 SIFAVITOR SRL DSM SINOCHEM PHARMACEUTICALS NL A A II II II 11/7/2003 11/7/2003 11/7/2003 BASF CORP TEVA PHARMACEUTICAL INDUSTRIES LTD SF-CHEM I I A III II II III 10/29/2003 11/5/2003 11/6/2003 11/6/2003 V 10/31/2003 A I II III II 10/31/2003 10/24/2003 10/31/2003 SCINOPHARM TAIWAN LTD AMERICHEM INC BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG LAUREATE BIOPHARMACEUTICAL SERVICES INC TREDEGAR FILM PRODUCTS CORP BACHEM CALIFORNIA TEVA PHARMACEUTICAL INDUSTRIES LTD SILGAN PLASTICS CORP A A II II III 10/20/2003 10/30/2003 10/30/2003 DR REDDYS LABORATORIES LTD CAMBRIDGE MAJOR LABS INC KOHL AND MADDEN II 10/20/2003 TEVA PHARMACEUTICAL INDUSTRIES LTD C II III 10/28/2003 10/17/2003 TEVA PHARMACEUTICAL INDUSTRIES LTD CLARIANT (CANADA) INC A A A II II II III 10/20/2003 10/6/2003 10/23/2003 10/28/2003 A II III 10/17/2003 10/24/2003 RANKE QUIMICA SL ACI PLASTICS PACKAGING CLOSURE SPECIALTY PRODUCTS SAFC INC UNICHEM LABORATORIES LTD NATCO PHARMA LTD BAXTER HEALTHCARE CORP LAS 34273 AS MANUFACTURED IN SANT ANDREU DE LA BARCA, SPAIN. STATUS Type SUBMIT DATE III 10/15/2003 HOLDER AMPACET CORP SUBJECT

4Q2012

110021-A WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA.

CELLOSEAL(TM) WADDING MATERIAL AS MANUFACTURED IN VICTORIA, AUSTRALIA. CALCIPOTRIENE AS MANUFACTURED IN MADISON, WI. CLONIDINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN RAIGAD, INDIA. SUMATRIPTAN SUCCINATE, PH. EUR AS MANUFACTURED IN ANDHRA PRADESH, INDIA. BIO-SET(R) LUER 20 (BIO-SET(R) INJECTION) AS MANUFACTURED IN ISSOIRE CEDEX AND DAGNEUX, FRANCE. BUDESONIDE AS MANUFACTURED IN EDO. DE MEXICO, MEXICO. RED CLARIANT MASTERBATCH 20PPP-1379 AS MANUFACTURED IN ONTARIO AND QUEBEC, CANADA. BECLOMETHASONE DIPROPIONATE ANHYDROUS, BULK DRUG SUBSTANCE AS MANUFACTURED IN SANTHIA (VERCELLI), ITALY. FLUNISOLIDE HEMIHYDRATE AS MANUFACTURED IN JIUTEPEC, MORELOS MEXICO FP-039 AS MANUFACTURED IN GERMANTOWN, WI. 2-LF-10554 BACKGROUND BLUE, 3-LF-20488 PMS 206C RED, AND 1-LF-256 DENSE BLACK AS MANUFACTURED IN TETERBORO, NJ. OXANDROLONE AS MANFACTURED IN TAINAN COUNTY, TAIWAN. 46189-CD1 WHITE AS MANUFACTURED IN CUYAHOGA FALLS, OH. ZOLPIDEM TARTRATE AS MANUFACTURED IN INGELHEIM, FEDERAL REPUBLIC OF GERMANY. CONTRACT MANUFACTURING FACILITY IN PRINCETON, NJ. LFL-4 POLYETHYLENE FILM AS MANUFACTURED IN MARLIN, PA. DESLORELIN AS MANUFACTURED IN TORRENCE, CA. HALOBETASOL PROPIONATE AS MANUFACTURED IN MEXICO. INJECTION MOLDED PLASTIC CLOSURE - LINED AND UNLINED / LINERLESS AS MANUFACTURED IN PENN YAN, NY; PLAINFIELD, IN; QUEBEC AND ONTARIO, CANADA POLYETHYLENE GLYCOLS AS MANUFACTURED IN WASHINGTON, NJ. DESMOPRESSIN AS MANUFACTURED IN BE'ER SHEVA AND NETANYA, ISRAEL. 3-CHLOROMETHYL-1,2,4-TRIAZOLIN-5-ONE (CMT) AS MANUFACTURED IN PRATTELN, SWITZERLAND. HALOPERIDOL DECANOATE AS MANUFACTURED IN LODI, ITALY. AMOXICILLIN TRIHYDRATE (PURIMOX(TM)) AS MANUFACTURED IN ALMERIA, SPAIN.

UNION QUIMICO FARMACEUTICA SA UQUIFA NIMODIPINE (MICRONIZED) AS MANUFACTURED IN BARCELONA, SPAIN. SA JOHNSON MATTHEY INC OXALIPLATIN AS MANUFACTURED IN WEST DEPTFORD, NJ. HOVIONE FARMACIENCIA SA WIPAK OY LOPAREX LLC HALOBETASOL PROPIONATE AS MANUFACTURED LOURES, PORTUGAL. INFUKING 200 AS MANUFACTURED IN NASTOLA, FINLAND. GRADE 24950 D 2 CL PET 7300/000 AS MANUFACTURED IN IOWA CITY, IA; EDEN, NC; DIXON, IL; CULLMAN, AL AND WILLOWBROOK, IL.

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4Q2012EXCEL DMF# 16956 16957 I 16958 16959 A 16960 A 16961 16962 A 16963 16964 A 16965 16966 16967 16968 A 16969 I 16970 16971 I 16972 A 16973 16974 A 16975 16976 16977 A 16978 A 16979 16980 16981 I 16982 I 16983 A II 11/26/2003 DR REDDYS LABORATORIES LTD III 11/17/2003 AMPACET CORP A A II II IV 11/25/2003 11/25/2003 11/24/2003 WOCKHARDT LTD RANBAXY LABORATORIES LTD SYMRISE INC II 11/19/2003 CATALENT PHARMA SOLUTIONS LLC A A II II II 11/20/2003 11/25/2003 11/21/2003 KYOWA HAKKO KOGYO CO LTD TARO PHARMACEUTICAL INDUSTRIES LTD CHENG FONG CHEMICAL CO LTD A II II 11/21/2003 11/20/2003 II 11/13/2003 I II II 11/18/2003 11/17/2003 II 11/12/2003 AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPA CADILA HEALTHCARE LTD I A A II II II II 11/17/2003 11/17/2003 11/17/2003 11/19/2003 TEVA GROUP DR REDDYS LABORATORIES LTD VIFOR INTERNATIONAL INC RANBAXY LABORATORIES LTD A II IV 11/17/2003 11/18/2003 CIPLA LTD CAPSUGEL RISPERIDONE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA. A II II 11/18/2003 11/17/2003 MYLAN LABORATORIES LTD II 11/14/2003 ABBOTT LABORATORIES C II III 11/14/2003 11/14/2003 TEVA PHARMACEUTICAL INDUSTRIES LTD BD MEDICAL PHARMACEUTICAL SYSTEMS STATUS Type SUBMIT DATE I III IV 9/1/2003 11/3/2003 HOLDER PROENFAR SA SYMRISE INC SUBJECT PACKAGING MATERIAL AS MANUFACTURED IN BOGOTA, COLUMBIA.

4Q2012

815485 NATURAL CHAI SPICE TYPE FLAVOR CONCENTRATE AS MANUFACTURED IN TETERBORO, TOTOWA AND BRACHBURG, NJ. CALCIPOTRIENE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. BD MONOVIAL(TM) SPIKE AS MANUFACTURED IN LE PONT DE CLAIX AND MARSEILLE CEDEX, FRANCE; AND DANIKEN, SWITZERLAND. ZOTAROLIMUS (ESUB) AS MANUFACTURED IN NORTH CHICAGO, IL AND TAINAN COUNTY, TAIWAN CITALOPRAM HYDROBROMIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

PHARMACEUTICAL WORKS POLPHARMA SA SODIUM ALENDRONATE AS MANUFACTURED IN STROGARD GDANSKI, POLAND.

EMPTY HARD CAPSULES FROM HYDROXYPROPYLMETHYLCELLULOSE (HYPROMELLOSE) AS MANUFACTURED IN MEXICO. GATIFLOXACIN AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. LEVETIRACETAM AS MANUFACTURED IN ANDHRA PRADESH, INDIA. VIT-45 POWDER AS MANUFACTURED IN ST. GALLEN, SWITZERLAND 7-AMINO-3-[(Z)-PROPEN-1-YL]-3-CEPHEM-4-CARBOXYLIC ACID (7-APCA) AS MANUFACTURED IN PUNJAB, INDIA. ANAGRELIDE HYDROCHLORIDE AS MANUFACTURED IN COMO, ITALY. LORATADINE AS MANUFACTURED IN GUJARAT, INDIA.

ANONIMA MATERIE SINTETICHE AND AFFINI FENOFIBRATE AS MANUFACTURED IN COMO, ITALY. SPA AMSA ANONIMA MATERIE SINTETICHE AND GLYCOPYRROLATE (ESUB) AS MANUFACTURED IN COMO, ITALY. AFFINI SPA RANBAXY LABORATORIES LTD CEFPROZIL USP (NON-STERILE BULK) AS MANUFACTURED IN PUNJAB, INDIA. CATALENT PHARMA SOLUTIONS LLC CALCITRIOL 0.25 MCG SOFT GELATIN CAPSULES AS MANUFACTURED IN ST. PETERSBURG, FL. PRAVASTATIN SODIUM AS MANUFACTURED IN YAMAGUCHI PREFECTURE, JAPAN. ONDANSETRON HYDROCHLORIDE AS MANUFACTURED IN HAIFA BAY, ISRAEL. PSEUDOEPHEDRINE HYDROCHLORIDE AS MANUFACTURED IN TAO YUAN HSIEN, TAIWAN. RISPERIDONE 0.5 MG AND 1.0 MG ORALLY DISINTEGRATING TABLETS AS MANUFACTURED IN SOMERSET, NJ. CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN MAHARASHTRA STATE, INDIA. CLORAZEPATE USP AS MANUFACTURED IN PUNJAB, INDIA. 346905 EVOGRAN CAPPUCCINO FLAVOR AS MANUFACTURED IN HLOZMINDEN, GERMANY. 100991-K PROFLOW 91 POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; DERIDDER, LA AND RAYONG, THAILAND. GLIMEPIRIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

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4Q2012EXCEL DMF# 16984 A 16985 16986 I 16987 A 16988 A 16989 A 16990 I 16991 I 16992 16993 16994 I 16995 16996 16997 16998 16999 17000 17001 17002 17003 17004 A 17005 I 17006 I 17007 17008 17009 C 17010 17011 I 17012 17013 A A II II 12/2/2003 12/10/2003 DR REDDYS LABORATORIES LTD MYLAN LABORATORIES LTD I II IV 2/28/2005 11/24/2003 ITF CHEMICAL LTDA SYMRISE INC A A II II II 12/1/2003 12/5/2003 12/5/2003 II 12/8/2003 II 12/8/2003 A A A A A A A A A II II II II II II II II II II 12/3/2003 12/3/2003 10/30/2003 12/1/2003 12/2/2003 12/3/2003 12/1/2003 12/3/2003 12/1/2003 12/8/2003 TEVA GROUP TEVA PHARMACEUTICAL INDUSTRIES LTD BACHEM AG INTERPHARMA PRAHA A S DR REDDYS LABORATORIES LTD MYLAN LABORATORIES LTD FIDIA FARMACEUTICI SPA CADILA HEALTHCARE LTD ALCHEM INTERNATIONAL LTD HENGSHUI JIHENG PHARMACEUTICAL CO LTD HENGSHUI JIHENG PHARMACEUTICAL CO LTD HENGSHUI JIHENG PHARMACEUTICAL CO LTD PCAS TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD A A II II III 11/17/2003 12/1/2003 11/26/2003 EXCELLA GMBH AUROBINDO PHARMA LTD LAJOVIC TUBA EMBALAZA D.D. III 11/19/2003 III 11/20/2003 BERRY PLASTICS CORP TAPES AND COATINGS DIV CLARIANT (CANADA) INC III 10/17/2003 PLIANT CORP II 11/14/2003 NOF CORP II 11/14/2003 NOF CORP I II III 11/26/2003 11/14/2003 HAUSER TECHNICAL SERVICES INC ERIE MOLDED PLASTICS INC STATUS Type SUBMIT DATE II 11/25/2003 HOLDER BIORESPONSE LLC SUBJECT

4Q2012

BIORESPONSE-DIINOLYLMETHANE (PG) (SPRAY DRIED DIINDOLYLMETHANE) AND BIORESPONSE-DIM (PG) CAPSULES (75 MG DIINDOLYLMETHANE) AS MANUFACTURED IN EXTON, PA, MIDDLESEX, NJ AND IOWA CITY, IA EPIGALLOCATECHIN GALLATE (EGCG) AS MANUFACTURED IN DENVER, CO. DISPENSING PLUG WITH A .178 ORIFICE THAT IS USED ON A BOTTLE FOR DISPENSING LIQUID MEDICINE AS MANUFACTURED IN ERIE, PA. POPC(FN) (1-PALMITOYL-2-OLEOYL PHOSPHATIDYLCHOLINE) AS MANUFACTURED IN HYOGO, JAPAN. POPC(ST) (1-PALMITOYL-2-OLEOYL PHOSPHATIDYLCHOLINE) AS MANUFACTURED IN HYOGO, JAPAN. PLIANT 105.1T POLYETHYLENE SHEETING FILM AS MANUFACTURED IN SOUTH DEERFIELD, MA 48 GAUGE CHEMICALLY TREATED POLYESTER/ 0.8# ADHESIVE / 0.0007 FOIL / 0.8# ADHESIVE / 2 MIL LLDPE FILM AS MANUFACTURED IN COLUMBUS, GA WHITE CLARIANT MASTERBATCH 10EHD-196A AS MANUFACTURED IN ONTARIO AND QUEBEC, CANADA. GANCICLOVIR SODIUM (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY. METFORMIN HYDROCHLORIDE AS MANUFACTURED IN A.P., INDIA. INJECTION BLOW MOLDED PLASTIC BOTTLES AS MANUFACTURED IN LJUBLJANA, SLOVENIA. TOLTERODINE TARTRATE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. LOSARTAN POTASSIUM AS MANUFACTURED IN BEER SHEVA, ISRAEL. HISTRELIN ACETATE AS MANUFACTURED IN BUBENDORF, SWITZERLAND. DIINDOLYLMETHANE (DIN) AS MANUFACTURED IN MODRANY, CZECH REPUBLIC MOXIFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. MOXIFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ACITRETIN AS MANUFACTURED IN GARBAGNATE MILANESE, ITALY. GATIFLOXACIN ANHYDROUS AS MANUFACTURED IN GUJARAT, INDIA. COLCHICINE USP AS MANUFACTURED IN NEW DELHI, INDIA. FOLIC ACID AS MANUFACTURED IN HEBEI PROVINCE, CHINA. ACETAMINOPHEN AS MANUFACTURED IN HEBEI PROVINCE, CHINA. METAMIZOLE SODIUM AS MANUFACTURED IN HEBEI PROVINCE, CHINA. CICLOPIROX AS MANUFACTURED IN TURKU, FINALAND. BICALUTAMIDE AS MANUFACTURED IN DEBRECEN, HUNGARY. CLOPIDOGREL BISULFATE AS MANUFACTURED IN CONSHOHOCKEN, PA AND BE'ER SHEVA, ISRAEL. AZITHROMYCIN MONOHYDRATE AS MANUFACTURED IN BAHIA, BRAZIL. 826506 ENTRAPPED NATURAL & ARTIFICIAL CHERRY TYPE FLAVOR AS MANUFACTURED IN BRANCHBURG, NJ. GATIFLOXACIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA. GATIFLOXACIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

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4Q2012EXCEL DMF# 17014 17015 17016 A 17017 A 17018 17019 17020 17021 17022 17023 17024 17025 17026 17027 17028 17029 17030 17031 17032 17033 17034 17035 17036 17037 17038 17039 17040 A 17041 17042 17043 A 17044 17045 A 17046 17047 A 17048 17049 I A II II 12/15/2003 12/22/2003 A II II 12/23/2003 12/23/2003 A IV II 12/22/2003 12/1/2003 SPI PHARMA INC GUILIN HUIANG BIOCHEMISTRY PHARMACEUTICAL CO LTD CRYSTAL PHARMA SAU ORCHID CHEMICALS AND PHARMACEUTICALS LTD ZACH SYSTEM S P A DSM FINE CHEMICALS AUSTRIA PHARMABURST(TM) C1 AS MANUFACTURED IN GRAND HAVEN, MI. PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN GUANGXI, P.R.CHINA. BETAMETHASONE DIPROPIONATE AS MANUFACTURED IN BOECILLO, SPAIN. CEFUROXIME ACID AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA. GLIMEPIRIDE AS MANUFACTURED IN BARCELONA, SPAIN. SECONDARY AMINE HCL AS MANUFACTURED IN LINZ, AUSTRIA. A A II III II 12/16/2003 11/28/2003 12/16/2003 A A A I A A I I A A N I A A A A A A A A A I II II II II II II II II II III II II 1/15/2004 12/10/2003 12/19/2003 12/17/2003 12/17/2003 12/16/2003 12/16/2003 12/17/2003 2/17/2004 12/12/2003 12/17/2003 12/18/2003 II II II III III II II II II II 12/11/2003 12/10/2003 12/11/2003 12/11/2003 12/12/2003 12/11/2003 12/12/2003 12/15/2003 12/15/2003 11/30/2003 CIPLA LTD MEDICHEM SA SIGMA ALDRICH MANUFACTURING LLC RELIANCE INDUSTRIES LTD FRANKLIN INTERNATIONAL APOTEX PHARMACHEM INC API CORP CIBA SPECIALTY CHEMICALS RANBAXY LABORATORIES LTD CHEMAGIS LTD NOT AN ASSIGNED NUMBER BASF ORGAMOL PHARMA SOLUTIONS SA EVERLIGHT CHEMICAL INDUSTRIAL CORP TEVA PHARMACEUTICAL INDUSTRIES LTD CIPLA LTD CIPLA LTD QILU PHARMACEUTICAL CO LTD SCINOPHARM TAIWAN LTD MALLINCKRODT INC CADILA HEALTHCARE LTD PINNACLE POLYMERS CO PISGAH LABS INC AMRI RENSSELAER INC SUB ALBANY MOLECULAR RESEARCH INC OLAINFARM JOINT STOCK CO DANAPAK FLEXIBLES AS ROCHE DIAGNOSTICS GMBH OXCARBAZEPINE AS MANUFACTURED IN SAINT-VULBAS, FRANCE. FELODIPINE AS MANUFACTURED IN TAIWAN, R.O.C. PREDNICARBATE AS MANUFACTURED IN LERMA, MEXICO. AMLODIPINE BESYLATE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA. RAMIPRIL (ESUB) AS MANUFACTURED IN PUNE, INDIA. ONDANSETRON HCL & BASE AS MANUFACTURED IN JINAN, CHINA. TOPIRAMATE AS MANUFACTURED IN TAIWAN, R.O.C. V 12/11/2003 STATUS Type SUBMIT DATE I A II II II 12/9/2003 12/1/2003 11/26/2003 HOLDER DR REDDYS LABORATORIES LTD BASF CORP TIANJIN TIANYAO PHARMACEUTICALS CO LTD WEST PHARMACEUTICAL SERVICES INC SUBJECT LANSOPRAZOLE FORM-1 AS MANUFACTURED IN ANDHRA PRADESH, INDIA. GLUCOPONA(R) 600 UP AS MANUFACTURED IN CINCINNATI, OH. BETAMETHASONE USP AS MANUFACTURED IN TIANJIN, CHINA.

4Q2012

WESTAR(R) RS PROCESS AS MANUFACTURED IN LE NOUVION EN THIERACHE, FRANCE. TOLTERODINE TARTRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. METOPROLOL SUCCINATE AS MANUFACTURED IN CELRA (GIRONA), SPAIN. 3-5-DIIODOTHYROPROPIONIC ACID (DITPA) AS MANUFACTURED IN ST.LOUIS, MO. POLYPROPYLENE (PP) REPOL H110MA AS MANUFACTURED IN GUJARAT, INDIA. COVINAX 379-05 AS MANUFACTURED IN COLUMBUS, OH. PRAVASTATIN SODIUM AS MANUFACTURED IN MANITOBA, CANADA. J-124429 (PED-704) AS MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN. TINOSORB(TM) MBBT AS MANUFACTURED IN LAMPERTHEIM, GERMANY. TOLTERODINE TARTRATE AS MANUFACTURED IN PUNJAB, INDIA. ZONISAMIDE AS MANUFACTURED IN BEER SHEVA, ISRAEL.

DCI(R)-63 (IBUPROFEN USP 63%) (ESUB) AS MANUFACTURED IN GREENVILLE, IL. TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA. POLYPROPYLENE AS MANUFACTURED IN GARYVILLE, LA. PHENTERMINE HYDROCHLORIDE, USP AS MANUFACTURED IN PISGAH FOREST, NC. MAC321 DRUG SUBSTANCE AS MANUFACTURED IN RENSSELAER, NY. ANAGRELIDE HYDROCHLORIDE AS MANUFACTURED IN OLAINE, LATVIA. COMPOUND PACKAGING MATERIAL AS MANUFACTURED IN SLAGELSE, DENMARK. GUAIACOL-O-ETHYLBENZYLAMINE HCL AS MANUFACTURED IN MANNHEIM, GERMANY.

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4Q2012EXCEL DMF# 17050 17051 17052 I 17053 I 17054 17055 17056 17057 17058 17059 17060 A 17061 17062 17063 17064 A 17065 17066 17067 17068 17069 17070 17071 17072 17073 17074 17075 A 17076 17077 A 17078 I 17079 17080 17081 17082 17083 I 17084 A II 12/12/2003 ISOCHEM SAS A A A A IV IV IV IV V 12/17/2003 12/17/2003 12/17/2003 12/17/2003 12/30/2003 BASF SE BASF SE BASF SE BASF SE CANGENE CORP IV 1/5/2004 TAKASAGO INTERNATIONAL CORP A II IV 11/25/2003 1/5/2004 EVERLIGHT CHEMICAL INDUSTRIAL CORP TAKASAGO INTERNATIONAL CORP I A A A A A A A I A II II II II II II IV III III II II 12/23/2003 12/31/2003 12/31/2003 12/31/2003 1/5/2004 12/29/2003 12/2/2003 11/14/2003 12/22/2003 1/6/2004 1/7/2004 OLAINFARM SCINOPHARM TAIWAN LTD SCINOPHARM TAIWAN LTD SCINOPHARM TAIWAN LTD ERCROS SA MOEHS IBERICA SL CRODA INC 3M PHARMACEUTICALS ERIE MOLDED PLASTICS INC SUN PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD A I A II IV II II 12/8/2003 12/26/2003 12/29/2003 12/29/2003 UQUIFA MEXICO SA DE CV DAICEL CHEMICAL INDUSTRIES LTD SUVEN LIFE SCIENCES LTD CIPLA LTD I A I A I A II II II III III II II 12/12/2003 12/19/2003 12/22/2003 12/15/2003 12/15/2003 12/19/2003 12/18/2003 CAMBREX CHARLES CITY INC CAMBREX CHARLES CITY INC IPCA LABORATORIES LTD AIRSEC SAS BESPAK INC FIS FABBRICA ITALIANA SINTETICI SPA II 12/22/2003 STATUS Type SUBMIT DATE A A II II II 12/22/2003 12/17/2003 12/23/2003 HOLDER DIPHARMA FRANCIS SRL TOMITA PHARMACEUTICAL CO LTD HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD TEVA PHARMACEUTICAL INDUSTRIES LTD SUBJECT CILOSTAZOL AS MANUFACTURED IN MERETO DI TOMBA, ITALY.

4Q2012

MAGNESIUM HYDROXIDE GRANULAR AS MANUFACTURED IN TOKUSHIMA, JAPAN. CLINDAMYCIN PHOSPHATE USP AS MANUFACTURED IN ZHEJIANG, P.R. CHINA. ONDANSETRON HYDROCHLORIDE DIHYDRATE AS MANUFACTURED IN ZAGREB, CROATIA. BUTALBITAL AS MANUFACTURED IN CHARLES CITY, IA. FENTANYL CITRATE USP AS MANUFACTURED IN NORTH BRUNSWICK, NJ. METOPROLOL SUCCINATE AS MANUFACTURED IN MADHYA PRADESH, INDIA. DESICCANT SACHET AS MANUFACTURED IN ST. MAMMES, FRANCE. SPACER INHALER AS MANUFACTURED IN APEX, NC. CMT AS MANUFACTURED IN VICENZA, ITALY.

PHARMACEUTICAL WORKS POLPHARMA SA CARVEDILOL AS MANUFACTURED IN STAROGARD GDANSKI, POLAND. CIPROFLOXACIN HYDROCHLORIDE, USP AS MANUFACTURED IN MORELOS, MEXICO. 1, 3-BUTYLENE GLYCOL DRUG EXCIPIENT AS MANUFACTURED IN NIIGATA, JAPAN. GABAPENTIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA. RIVASTIGMINE HYDROGEN TARTRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. CYCLOPHOSPHAMIDE AS MANUFACTURED IN OLAINE, LATVIA. MESTRANOL AS MANUFACTURED IN TAIWAN, R.O.C. LEVONORGESTREL AS MANUFACTURED IN TAIWAN, R.O.C. NORGESTREL AS MANUFACTURED IN TAIWAN, R.O.C. LOVASTATIN AS MANUFACTURED IN MADRID, SPAIN. AMLODIPINE BESILATE AS MANUFACTURED IN BARCELONA, SPAIN. TWEEN 80 HP-LQ-(MH) AS MANUFACTURED IN MILL HALL PA COTRAN(R) 9707 AS MANUFACTURED IN BROOKINGS, SD. DOSAGE SPOON AS MANUFACTURED IN ERIE, PA. CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN GUJARAT, INDIA. RASAGILINE MESYLATE (ESUB) AS MANUFACTURED IN BEER SHEVA AND KFARSABA, ISRAEL. MISOPROSTOL - HPMC 1% DISPERSION AS MANUFACTURED IN TAIWAN, R.O.C. TAK-031431 MICORN(R) INTENSATES(R) NATURAL & ARTIFICIAL BLEND MASKING TYPE AS MANUFACTURED IN TETERBORO, NJ. TAK-032230 NATURAL & ARTIFICIAL COOL PEPPERMINT FLAVOR OS AS MANUFACTURED IN TETERBORO, NJ. Kolliphor(R) CS 12 AS MANUFACTURED IN DUESSELDORF, GERMANY. KOLLIWAX(R) CSA 50 AS MANUFACTURED IN DUESSELDORF, GERMANY. KOLLIWAX(R) SA AS MANUFACTURED IN DUESSELDORF, GERMANY. KOLLIWAX(R) CA AS MANUFACTURED IN DUESSELDORF, GERMANY. NP-015-ANTHRAX IMMUNE GLOBULIN (HUMAN) INTRAVENOUS AS MANUFACTURED IN MANITOBA, CANADA. DIOSMINE AS MANUFACTURED IN PITHIVIERS, FRANCE.

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4Q2012EXCEL DMF# 17085 17086 17087 17088 17089 17090 17091 17092 17093 17094 I 17095 17096 I 17097 17098 17099 A 17100 I 17101 17102 17103 17104 17105 17106 A 17107 17108 I 17109 I 17110 17111 I 17112 I 17113 A 17114 17115 A 17116 A III 12/15/2003 BASF SE A II II 1/19/2004 1/23/2004 MALLINCKRODT INC SANOFI CHIMIE EXENATIDE (ESUB) AS MANUFACTURED IN ST. LOUIS, MO. II 1/21/2004 NV ORGANON IV 1/19/2004 SYMRISE INC A II IV 1/21/2004 1/19/2004 II 1/20/2004 I II II 1/21/2004 1/20/2004 A A A I I III III II II II II 1/9/2004 1/9/2004 1/20/2004 1/13/2004 1/14/2004 1/14/2004 ALBIS PLASTIC GMBH ALBIS PLASTIC GMBH DR REDDYS LABORATORIES LTD HEUMANN PHARMA GMBH MOEHS IBERICA SL ORCHID CHEMICALS AND PHARMACEUTICALS LTD CIPLA LTD III 1/14/2004 SOLVIN SA I A II II III 1/14/2004 12/12/2003 1/7/2004 GLENMARK GENERICS LTD CAMBREX CHARLES CITY INC BETTS UK LTD A II II 1/12/2004 12/16/2003 STATUS Type SUBMIT DATE I A A A N A I A A II II II II II 1/8/2004 12/31/2003 1/12/2004 1/14/2004 1/14/2004 II II IV IV 12/29/2003 1/5/2004 12/3/2003 3/30/2004 HOLDER YONEZAWA HAMARI CHEMICALS LTD BUCHLER GMBH EMERSON RESOURCES INC MANE INC NOT AN ASSIGNED NUMBER SUN PHARMACEUTICAL INDUSTRIES LTD ALEMBIC LTD API DIV CADILA HEALTHCARE LTD CADILA PHARMACEUTICALS LTD HENAN KAIFENG PHARMACEUTICAL FACTORY LUBRIZOL ADVANCED MATERIALS INC GE HEALTHCARE PANTOPRAZOLE SODIUM AS MANUFACTURED IN MAHARASHTRA, INDIA. AZITHROMYCIN MONOHYDRATE AS MANUFACTURED IN GUJARAT, INDIA. GATIFLOXACIN SESQUIHYDRATE AS MANUFACTURED IN GUJARAT, INDIA. GLYBURIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA. DOXYCYCLINE HYDROCHLORIDE AS MANUFACTURED IN KAIFENG, CHINA CARBOPOL(R) 71G NF AS MANUFACTURED IN CALVERT CITY, KY. SUBJECT FARGA-3 AS MANUFACTURED IN YAMAGATA, JAPAN. QUININE SULFATE, USP AS MANUFACTURED IN BRAUNSCHWEIG, GERMANY. PLAS II AS MANUFACTURED IN NORRISTOWN, PA. BANANA FLAVOR E_9930469 AS MANUFACTURED IN BAR-SUR-LOUP, FRANCE.

4Q2012

123I-META-IODOBENZYLGUANIDINE (MIBG) AS MANUFACTURED IN EINDHOVEN, NETHERLANDS FLUCONAZOLE AS MANUFACTURED IN GUJARAT STATE, INDIA. ZOLPIDEM TARTRATE AS MANUFACTURED IN CHARLES CITY, IOWA. METERED DOSE INHALER ACTUATORS AS MANUFACTURED IN ESSEX, UNITED KINGDOM. SOLVIN(R) 260RC AS MANUFACTURED IN BELGIUM, FRANCE, GERMANY, SPAIN AND BRAZIL. ALTECH SAN B 1000/01 BK1092-03 AS MANUFACTURED IN HAMBURG, GERMANY. ALTECH SAN B 1000/01 VT1093-03 AS MANUFACTURED IN HAMBURG, GERMANY. PANTOPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN FEUCHT, GERMANY. AMLODIPINE BASE AS MANUFACTURED IN BARCELONA, SPAIN. CEFADROXIL AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA. AMLODIPINE MESYLATE MONOHYDRATE AS MANUFACTURED IN BANGALORE, INDIA.

FUJIAN FUKANG PHARMACEUTICAL CO LTD 7-AMINO CEPHALOSPORANIC ACID (7-ACA) AS MANUFACTURED IN FUZHOU, CHINA. FUJIAN FUKANG PHARMACEUTICAL CO LTD TOBRAMYCIN SULFATE AS MANUFACTURED IN FUZHOU, THE PEOPLE'S REPUBLIC OF CHINA. HETERO DRUGS LTD GATIFLOXACIN HEMIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. SYMRISE INC 204798 OPTAMINT ROSE FLAVOR AS MANUFACTURED IN HOLZMINDEN, FEDERAL REPUBLIC OF GERMANY. 205622 OPTACOOL(R) C SPECIAL FLAVORING AS MANUFACTURED IN HOLZMINDEN, FEDERAL REPUBLIC OF GERMANY. HYDROXYPROGESTERONE CAPROATE AS MANUFACTURED IN OSS, THE NETHERLANDS.

17-DEACETYLNORGESTIMATE (NORELGESTROMIN) AS MANUFACTURED IN VERTOLAYE, FRANCE. LUWAX AF 31 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

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4Q2012EXCEL DMF# 17117 A 17118 17119 17120 17121 17122 17123 17124 I 17125 17126 I 17127 17128 17129 17130 I 17131 A 17132 17133 17134 A 17135 A 17136 17137 A 17138 I 17139 A 17140 17141 A 17142 17143 17144 I 17145 17146 17147 I I I II II III 2/4/2004 2/10/2004 9/15/2004 ASAHI GLASS CO LTD UBE INDUSTRIES LTD ATOFINA RESEARCH SA A A II II II 1/30/2004 2/4/2004 2/4/2004 A II II 2/6/2004 2/4/2004 TOKUYAMA CORP TIANJIN TIANYAO PHARMACEUTICALS CO LTD NCPC HUALUAN PHARMACEUTICAL CO LTD MEDICHEM SA ACS DOBFAR UK LTD III 2/2/2004 MITSUBISHI GAS CHEMICAL CO INC III 1/12/2004 SPARTECH COLOR A II III 1/30/2004 1/30/2004 II 1/30/2004 A I IV II II 1/29/2004 1/26/2004 1/30/2004 LENDELL MANUFACTURING INC CORDEN PHARMA SWITZERLAND LLC ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD RELIABLE BIOPHARMACEUTICAL CORP DEWAL INDUSTRIES INC II 1/19/2004 A A I IV II III II 1/28/2004 1/28/2004 1/23/2004 1/23/2004 N II 1/12/2004 NOT AN ASSIGNED NUMBER SANDOZ SYNTEK ILAC HAMMADDELERI SANAYI VE TICARET AS HENKEL CORP HARMAN FINOCHEM LTD SUMMIT PACKAGING SYSTEMS INC XI'AN HUIFENG BIOCHEMISTRY GROUP CO LTD DOTTIKON EXCLUSIVE SYNTHESIS AG OMEPRAZOLE AS MANUFACTURED IN ISTANBUL, TURKEY. DURO-TAK(R) 87-6173 AS MANUFACTURED IN SALISBURY, NC. ALLOPURINOL AS MANUFACTURED IN MAHARASHTRA, INDIA. AEROSOL VALVE AS MANUFACTURED IN MANCHESTER, NH AND RACINE, WI. C A A A A A II III III III II II III 1/26/2004 1/14/2004 1/14/2004 1/14/2004 1/29/2004 1/27/2004 1/22/2004 TEVA PHARMACEUTICAL INDUSTRIES LTD HINDALCO INDUSTRIES LTD HINDALCO INDUSTRIES LTD HINDALCO INDUSTRIES LTD DR REDDYS LABORATORIES LTD BIOCON LTD INOAC PACKAGING GROUP INC STATUS Type SUBMIT DATE II 1/23/2004 HOLDER LONZA INC SUBJECT DEXMETHYLPHENIDATE HYDROCHLORIDE (DMP.HCL) AS MANUFACTURED IN CONSHOHOCKEN, PA. PANTOPRAZOLE SODIUM AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. ALUMINIUM STRIP PACKAGING FOIL AS MANUFACTURED IN THANE, INDIA. ALUMINIUM BLISTER PACKAGING FOIL AS MANUFACTURED IN THANE, INDIA. ALU-ALU BLISTER FOIL AS MANUFACTURED IN THANE, INDIA. QUETIAPINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

4Q2012

HUMAN INSULIN-BULK (RDNA ORIGIN) AS MANUFACTURED IN BANGALORE, INDIA. 50ML POLYETHYLENE TEREPHTHALATE BOTTLE PACKAGING COMPONENT AS MANUFACTURED IN BARDSTOWN, KY AND MEXICO.

AMLODIPINE MALEATE AND BESYLATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN SHANXI, CHINA. PENTAERYTHRITOL TETRANITRATE (DILUTED) AS MANUFACTURED IN DOTTIKON, SWITZERLAND. HDW-2002 PREPOLYMER AS MANUFACTURED IN ST. CHARLES, MI. VAPREOTIDE ACETATE AS MANUFACTURED IN LIESTAL, SWITZERLAND. CEFUROXIME AXETIL, AMORPHOUS AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA. CEFUROXIME AXETIL, CRYSTALLINE AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA. FLUDARABINE PHOSPHATE AS MANUFACTURED IN ST. LOUIS, MO. 950-56 (LAMINATE OF PTFE FILM AND POLYETHYLENE FOAM) AS MANUFACTURED IN NARRAGANSETT, RI. WH 18485, WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN ONTARIO, CANADA. OXYGEN ABSORBERS PHARMAKEEP TYPES KD AND KH AS MANUFACTURED IN TOKYO, JAPAN. PROPANTHELINE BROMIDE AS MANUFACTURED IN IBARAKI, JAPAN. DEXAMETHASONE, USP AS MANUFACTURED IN TIANJIN, CHINA. LINCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN SHIJIAZHUANG, CHINA. CHLORHEXIDINE DIHYDROCHLORIDE AS MANUFACTURED IN CELRA (GIRONA), SPAIN. 6-AMINOPENICILLANIC ACID (6-APA) AS MANUFACTURED IN NORTHUMBERLAND, UNITED KINGDOM. HYDRAZINE-DIOL AS MANUFACTURED IN KANAGAWA, JAPAN. CS-526 DRUG SUBSTANCE AS MANUFACTURED IN TOKYO, JAPAN. POLYPROPYLENE RESIN PELLETS PPH 7060, PPC 5660, PPR 7220, PPR 3261 AS MANUFACTURED IN FRANCE AND BELGIUM.

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4Q2012EXCEL DMF# 17148 A 17149 A 17150 17151 17152 17153 I 17154 17155 17156 17157 A 17158 A 17159 17160 I 17161 17162 17163 A 17164 17165 I 17166 17167 I 17168 17169 17170 17171 A 17172 17173 17174 17175 A 17176 17177 17178 17179 A A A A III III III III 2/13/2004 2/13/2004 2/13/2004 2/13/2004 POLYONE CORP POLYONE CORP POLYONE CORP POLYONE CORP CC10009664BG AS MANUFACTURED IN BENDORF, GERMANY. CC10009679BG AS MANUFACTURED IN BENDORF, GERMANY. CC10009685BG AS MANUFACTURED IN BENDORF, GERMANY. CC10009868BG AS MANUFACTURED IN BENDORF, GERMANY. A A A III III II II 2/18/2004 1/21/2004 2/13/2004 1/23/2004 POLYONE CORP ASTRA PLASTIQUE KREBS BIOCHEMICALS INDUSTRIES LTD NATCO PHARMA LTD I I A II III II II 2/19/2004 11/25/2003 2/18/2004 2/11/2004 A II III 2/18/2004 1/30/2004 PROTO CHEMICALS AG TOTAL PETROCHEMICALS RESEARCH FELUY SA ASTELLAS PHARMA INC REXPLAS BAYER SCHERING PHARMA AG FIDIA FARMACEUTICI SPA A II III 12/10/2003 2/19/2004 LONZA LTD COLORTECH INC A A III II III 2/6/2004 2/13/2004 2/16/2004 I V V 2/4/2004 1/20/2004 DISCOVERY LABORATORIES INC III 2/13/2004 ILC DOVER N A A IV II II 2/16/2004 2/16/2004 2/13/2004 A A A II II II III 2/10/2004 2/10/2004 1/20/2004 2/5/2004 SANOFI AVENTIS SPA KREBS BIOCHEMICALS INDUSTRIES LTD AUROBINDO PHARMA LTD BERRY PLASTICS CORP TAPES AND COATINGS DIV NOT AN ASSIGNED NUMBER COLORCON SIFAVITOR SRL NV ORGANON III 2/10/2004 CONSTANTIA TOBEPAL SLU STATUS Type SUBMIT DATE II 2/6/2004 HOLDER CIPLA LTD SUBJECT

4Q2012

MELOXICAM BP (ESUB) AS MANUFACTURED IN MAHARASHTRA, BANGALORE, MUMBAI AND VERNA SALCETTE GOA, INDIA. FLEXIBLE PACKAGING MATERIAL FOR HEALTHCARE AND FOOD PRODUCTS AS MANUFACTURED IN LOGRONO AND BURGOS, SPAIN. RIFAXIMIN AS MANUFACTURED IN BRINDISI, ITALY. SIMVASTATIN USP AS MANUFACTURED IN HYDERABAD, INDIA. GLYBURIDE AS MANUFACTURED IN A.P., INDIA. 25# OR 26# BLEACHED C1S KRAFT PAPER/ 9# LDPE/ .000332 FOIL/ 21# SURLYN AS MANUFACTURED IN HOMER, LA. COLORCON NO-TOX(R) PRODUCTS AS MANUFACTURED IN CHALFONT, PA. CICLOPIROX AS MANUFACTURED IN CASALETTO LODIGIANO, ITALY. TETRACOSACTIDE AS MANUFACTURED IN OSS, THE NETHERLANDS AND SERIFONTAINE, FRANCE. MASTERBATCHES AND FILMS FOR THE PHARMACEUTICAL INDUSTRY AS MANUFACTURED IN FREDERICA, DE; CARBONDALE, PA; MARTIN, MI; CINCINNATI, OH; AND HAMMONTON AND HAWTHORNE, NJ. STERILE MANUFACTURING FACILITY IN TOTOWA, NJ.

CINCINNATI CHILDREN'S HOSPITAL MEDICAL TRANSLATIONAL TRIALS DEVELOPMENT AND SUPPORT LABORATORY (TTDSL) AND CENTER CINCINNATI CHILDREN'S RESEARCH FOUNDATION (CCRF) IN CINCINNATIO, OH. BHARAT RUBBER WORKS PVT LTD RUBBER STOPPER AS MANUFACTURED IN MUMBAI, INDIA. DAIICHI SANKYO CO LTD BESPAK DIV CONSORT MEDICAL PLC DU-176B DRUG SUBSTANCE AS MANUFACTURED IN TOKYO, JAPAN. BK 357916MT PHARMACEUTICAL METERING VALVE AS MANUFACTURED IN NORFOLK, ENGLAND. SECAMINE HYDROCHLORIDE AS MANUFACTURED IN VISP, SWITZERLAND. 11002-19 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN AND ONTARIO, CANADA. TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN MITLODI, SWITZERLAND. HIGH DENSITY POLYETHYLENE RESINS LACQTENE 2003SN53 AND LACQTENE 2020SB5 AS MANUFACTURED IN HARFLEUR, FRANCE. FK962 AS MANUFACTURED IN OSAKA, JAPAN. PACKAGING MATERIAL AS MANUFACTURED IN ONTARIO, CANADA. ILOPROST AS MANUFACTURED IN BERLIN, GERMANY. SIBUTRAMINE HYDROCHLORIDE ANHYDROUS AS MANUFACTURED IN GARBANGNATE MILANESE (MI), ITALY. CC00018098WE AS MANUFACTURED IN GLENDALE, AZ. CLOSURE VISTOP 36 AS MANUFACTURED IN SAINT-GEORGE DE RENEINS, FRANCE. LOVASTATIN USP AS MANUFACTURED IN A.P., INDIA. ECT-12003 (S-CITALOPRAM OXALATE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

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4Q2012EXCEL DMF# 17180 17181 17182 I 17183 17184 A 17185 17186 17187 17188 A 17189 A 17190 I 17191 I 17192 I 17193 17194 17195 17196 17197 A 17198 17199 17200 17201 A 17202 A 17203 A 17204 A 17205 17206 I 17207 A IV 2/18/2004 EMERSON RESOURCES INC N III 2/19/2004 NOT AN ASSIGNED NUMBER AMPACET CORP III 2/27/2004 TEKNOR COLOR CO III 2/27/2004 TEKNOR COLOR CO III 2/27/2004 TEKNOR COLOR CO A I A IV II V III 2/27/2004 2/26/2004 2/18/2004 2/27/2004 A I A A II IV III III II 2/26/2004 3/1/2004 2/18/2004 2/18/2004 2/22/2004 EGIS PHARMACEUTICALS PLC COLORCON POLYONE CORP POLYONE CORP HEBEI ZHONGRUN PHARMACEUTICAL CO LTD BASF SE PIERRE FABRE MEDICAMENT WAISMAN CENTER TEKNOR COLOR CO III 2/9/2004 RELIANCE INDUSTRIES LTD III 2/9/2004 RELIANCE INDUSTRIES LTD III 2/9/2004 II 3/9/2004 ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI INEOS USA LLC A A A II II II III 2/4/2004 2/26/2004 2/25/2004 2/19/2004 NATCO PHARMA LTD SUN PHARMACEUTICAL INDUSTRIES LTD CIPLA LTD FUJIMORI KOGYO CO LTD A II II 2/20/2004 2/23/2004 SANDOZ GMBH EUTICALS SPA STATUS Type SUBMIT DATE A A III III III 2/13/2004 2/13/2004 2/19/2004 HOLDER POLYONE CORP POLYONE CORP AMPACET CORP SUBJECT CC10009872BG AS MANUFACTURED IN BENDORF, GERMANY. CC10009662BG AS MANUFACTURED IN BENDORF, GERMANY.

4Q2012

LR-124510 BLUE MLLD POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA. VICA CRUDE AS MANUFACTURED IN TYROL, AUSTRIA. AZTREONAM INTERMEDIATE NON-STERILE ALPHA-FORM AS MANUFACTURED IN ROZZANO, ITALY. CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. AMIFOSTINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA. CARVEDILOL (ESUB) AS MANUFACTURED IN PUNE, INDIA. PLASTIC FILM AND BAG FOR USE IN DRUG SUBSTANCE AND PRODUCT CONTAINERS AS MANUFACTURED IN MIE AND SHIZUOKA PREFECTURE, JAPAN. SULBACTAM SODIUM STERILE, USP (BULK) AS MANUFACTURED IN LATINA, ITALY. POLYPROPYLENE RAW MATERIAL REPOL R120MK AS MANUFACTURED IN GUJARAT, INDIA. POLYPROPYLENE RAW MATERIAL REPOL R019MZ AS MANUFACTURED IN GUJARAT, INDIA. POLYPROPYLENE RAW MATERIAL REPOL H200MK AS MANUFACTURED IN GUJARAT, INDIA. ETHACRYNIC ACID AS MANUFACTURED IN BUDAPEST, HUNGARY. CHR. HANSEN(TM) SUGAR SPHERE AS MANUFACTURED IN STOUGHTON, WI. CC00015878WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL. CC00015846WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL. 6 APA (6-AMINO-PENICILLIC ACID) AS MANUFACTURED IN HEBEI, CHINA. KOLLIPHOR(R) CS 20 AS MANUFACTURED IN DUESSELDORF, GERMANY. CICLOPIROX AS MANUFACTURED IN GAILLAC CEDEX, FRANCE. WAISMAN CLINICAL BIOMANUFACTURING FACILITY IN MADISON, WI. COLOR CONCENTRATE 84,060CP YELLOW 2% AND ITS COMPOSITION AS MANUFACTURED IN HENDERSON, KY; FOUNTAIN INN, SC; JACKSONVILLE, TX AND LODI, OH. COLOR CONCENTRATE 55,275CP GREEN 2% AND ITS COMPOSITION AS MANUFACTURED IN HENDERSON, KY; FOUNTAIN INN, SC; JACKSONVILLE, TX AND LODI, OH. COLOR CONCENTRATE 45,703CP BLUE 2% AND ITS COMPOSITION AS MANUFACTURED IN HENDERSON, KY; FOUNTAIN INN, SC; JACKSONVILLE, TX AND LODI, OH. COLOR CONCENTRATE 65,843CP RED 2% AND ITS COMPOSITION AS MANUFACTURED IN HENDERSON, KY; FOUNTAIN INN, SC; JACKSONVILLE, TX AND LODI, OH. 171083 TRANS MINT GREEN POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA. MARCOAT 125 AS MANUFACTURED IN NORRISTOWN, PA.

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4Q2012EXCEL DMF# 17208 17209 A 17210 17211 17212 17213 17214 17215 17216 I 17217 17218 I 17219 17220 17221 17222 17223 A 17224 17225 17226 A 17227 17228 17229 17230 17231 17232 I 17233 17234 A 17235 17236 17237 17238 A 17239 17240 17241 A I A IV II V 3/18/2004 3/18/2004 3/12/2004 A A A II III III II 2/16/2004 3/9/2004 2/6/2004 3/16/2004 SIFAVITOR SRL ZEON CORP NIPRO TUBE GLASS LIMITED A II II 3/12/2004 3/8/2004 SIGMA ALDRICH MANUFACTURING LLC NOF CORP A I I I A II III II II II III 3/5/2004 3/12/2004 3/12/2004 3/12/2004 3/12/2004 3/3/2004 BACHEM AMERICAS INC CYTEC SSURFACE SPECIALITIES DAIICHI SANKYO CO LTD MEDICHEM SA MEDICHEM SA CLARIANT AUSTRALIA PTY LTD A A II II II 3/5/2004 3/5/2004 3/9/2004 SIGNA SA DE CV SIGNA SA DE CV ECKERT AND ZIEGLER RADIOPHARMA INC A I A I III III II III II 3/8/2004 3/4/2004 3/9/2004 3/10/2004 3/10/2003 3M PHARMACEUTICALS SBC HUMPHREY COSBURN PLASTICS SIEGFRIED LTD SOVEREIGN SPECIALTY CHEMICALS INC CIPLA LTD I II II 3/5/2004 3/4/2004 AUROBINDO PHARMA LTD CHEMWERTH INC A A I A I I IV II III IV II II II 3/5/2004 3/4/2004 2/24/2004 3/1/2004 3/30/2004 3/4/2004 3/4/2004 CAPSUGEL MYLAN LABORATORIES LTD HB FULLER CO DOW CORNING CORP SIGMA ALDRICH CO IRVINE SCIENTIFIC SALES CO IRVINE SCIENTIFIC SALES CO STATUS Type SUBMIT DATE A IV III 2/18/2004 12/23/2003 HOLDER EMERSON RESOURCES INC BORMIOLI ROCCO SPA BU PLASTICS SUBJECT MARCOAT 125N AS MANUFACTURED IN NORRISTOWN, PA.

4Q2012

CHILD-PROOF CAP 18 MM AS MANUFACTURED IN SAINT SULPICE, FRANCE, CASTELGUELFO (PR) AND RIVANAZZANO (PV), ITALY. POLYSACCHARIDE EMPTY HARD CAPSULES AS MANUFACTURED IN PUEBLA, MEXICO. AMLODIPINE BESYLATE USP (ADP) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. HL0916SUV AS MANUFACTURED IN QUEBEC, CANADA. DOW CORNING(R) ST ELASTOMER 10 AS MANUFACTURED IN HEMLOCK, MI. CHO ANIMAL-FREE MEDIUM MODIFICATION 21 AS MANUFACTURED IN ST. LOUIS, MO. IS CHO-CD4(TM) A CELL CULTURE MEDIUM AS MANUFACTURED IN SANTA ANA, CA. IS CHO-CD4(TM) POWDER A CELL CULTURE MEDIUM AS MANUFACTURED IN SANTA ANA, CA. AMIODARONE HYDROCHLORIDE AS MANUFACTURED IN A.P., INDIA. DAUNORUBICIN HYDROCHLORIDE (TECHNICAL GRADE) AS MANUFACTURED IN DISTRICT BHARUCH, INDIA FOR CHEMWERTH INC SCOTHPAK(TM) 9730 AS MANUFACTURED IN COTTAGE GROVE, MN. FLIP-TOP DISPENSING CAP AS MANUFACTURED IN ONTARIO, CANADA. NICOTINE BITARTRATE DIHYDRATE AS MANUFACTURED IN ZOFINGEN, SWITZERLAND. PROXSEAL 8480-107 AS MANUFACTURED IN BUFFALO, NY. VALACYCLOVIR HYDROCHLORIDE DIHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA. VALPROIC ACID AS MANUFACTURED IN TOLUCA, MEXICO. SODIUM VALPROATE ACID AS MANUFACTURED IN TOLUCA, MEXICO. YTTRIUM-90 CHLORIDE STERILE SOLUTION AS MANUFACTURED IN BRAUNSCHWEIG, GERMANY. EXENATIDE (BULK) AS MANUFACTURED IN TORRANCE, CA. PHENODUR(R) PR 612/80B AS MANUFACTURED IN WEISBADEN, GERMANY. CS-023 DRUG SUBSTANCE AS MANUFACTURED IN KANAGAWA, JAPAN. ZALEPLON AS MANUFACTURED IN CELRA (GIRONA), SPAIN. LAMOTRIGINE AS MANUFACTURED IN CELRA (GIRONA), SPAIN. CUSTOM COLOUR/ADDITIVE CONCENTRATES FOR USE IN PLASTIC PRODUCTS AND PACKAGING POLY-L-LYSINE HYDROCHLORIDE AS MANUFACTURED IN ST. LOUIS, MO. PURIFIED EGG YOLK SPHINGOMYELIN (PURIFIED EY-SPM) AS MANUFACTURED IN HYOGO, JAPAN. BETAXOLOL HYDROCHLORIDE AS MANUFACTURED IN MURCIA, SPAIN. CYCLO OLEFIN POLYMER 2 AS MANUFACTURED IN OKAYAMA, JAPAN. GLASS CONTAINERS AS MANUFACTURED IN MAHARASHTRA, INDIA.

ANONIMA MATERIE SINTETICHE AND AFFINI MELOXICAM (ESUB) AS MANUFACTURED IN COMO, ITALY SPA COLORCON CHR. HANSEN(TM) CAL-CARB AS MANUFACTURED IN STOUGHTON, WI. SUN PHARMACEUTICAL INDUSTRIES LTD NATIONAL INSTITUTES HEALTH NATIONAL INSTITUTE DRUG ABUSE GABAPENTIN AS MANUFACTURED IN MAHARASHTRA, INDIA. PRECLINICAL STUDIES ON IBOGAINE

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4Q2012EXCEL DMF# 17242 A 17243 17244 A 17245 17246 A 17247 17248 17249 A 17250 I 17251 17252 17253 A 17254 17255 A 17256 17257 A 17258 A 17259 17260 I 17261 I 17262 17263 A 17264 A 17265 A 17266 17267 17268 17269 17270 N I I I A III III III II 3/17/2004 3/17/2004 3/17/2004 3/23/2004 NOT AN ASSIGNED NUMBER DYNA-TECH ADHESIVES DYNA-TECH ADHESIVES DYNA-TECH ADHESIVES ICROM SPA III 3/26/2004 MULTISORB TECHNOLOGIES INC II 3/26/2004 I II II 3/26/2004 3/15/2004 SIGMA ALDRICH CO SHANDONG XINHUA PHARMACEUTICAL CO LTD SANOFI CHIMIE IV 3/25/2004 WILD FLAVORS INC A II II 3/25/2004 3/24/2004 ACS DOBFAR SPA CATALENT PHARMA SOLUTIONS LLC II 3/1/2004 I III II 2/27/2004 3/30/2004 I II II 3/26/2004 3/23/2004 A I III II III 3/18/2004 3/18/2004 2/25/2004 POLYONE CORP LONZA LTD PLASTWAL LATINO AMERICANA INDUSTRIA E COMERCIO LTDA PROCOS SPA CC00014449WE AS MANUFACTURED IN GLENDALE, AZ. KW-2401 AS MANUFACTURED IN VISP, SWITZERLAND. BLISTER FILMS AS MANUFACTURED IN SAO PAULO, BRAZIL. ZONISAMIDE AS MANUFACTURED IN NOVARA, ITALY. III 3/10/2004 AMPACET CORP A A II II II 3/19/2004 3/22/2004 3/19/2004 DR REDDYS LABORATORIES LTD RELIABLE BIOPHARMACEUTICAL CORP DR REDDYS LABORATORIES LTD A II III 3/19/2004 3/8/2004 DR REDDYS LABORATORIES LTD COLORTECH INC A II III 3/19/2004 3/18/2004 NV ORGANON FLEXTRUS AB STATUS Type SUBMIT DATE IV 3/5/2004 HOLDER CAPSUGEL SUBJECT

4Q2012

POLYSACCHARIDE EMPTY HARD CAPSULES AS MANUFACTURED IN KANAGAWA PREFECTURE, JAPAN. LEUPRORELIN AS MANUFACTURED IN OSS, THE NETHERLANDS TRANSOFOIL EL-OPET/PE LAMINATE, MATERIAL SPECIFICATION: M80109 AS MANUFACTURED IN LUND, SWEDEN. REPAGLINIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. 11002-19 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN AND ONTARIO, CANADA. TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. FENOLDOPAM MESYLATE, USP AS MANUFACTURED IN ST. LOUIS, MO. RIVASTIGMINE HYDROGEN TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. 191121 GREY POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA.

UNION QUIMICO FARMACEUTICA SA UQUIFA OMEPRAZOLE AS MANUFACTURED IN BARCELONA, SPAIN. SA MATRIX PACKAGING INC PLASTICS CONTAINERS AS MANUFACTURED IN BRAMPTON, ON, CANADA. ORCHID CHEMICALS AND PHARMACEUTICALS LTD MOEHS IBERICA SL CEFTRIAXONE SODIUM AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA. VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN SANTANDER AND BARCELONA, SPAIN. CEFTRIAXONE SODIUM, USP (STERILE BULK) AS MANUFACTURED IN MILANO, ITALY. RISPERIDONE 2.0 MG ORALLY DISINTEGRATING TABLETS AS MANUFACTURED IN SOMERSET, NJ. NATURAL AND ARTIFICIAL GRAPE FLAVOR WITH COLOR #FAFH081 (ALSO REFERRED TO AS #450679) AS MANUFACTURED IN ERLANGER, KY. 3-AMINO-1-PROPANESULFONIC ACID AS MANUFACTURED IN ST. LOUIS, MO. HYDROCORTISONE ACETATE, USP (BULK) AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA. SPIRONOLACTONE MICRONIZED, PH. EUR, USP, JP AS MANUFACTURED IN VERTOLAYE, FRANCE. STABILOX(TM) OXYGEN ABSORBING PRODUCTS AS MANUFACTURED IN BUFFALO, NY.

DYNA-TECH ADHESIVES - TECHCRYL 2233 AS MANUFACTURED IN GRAFTON, WV. DYNA-TECH ADHESIVES - TECHCRYL 6136 AS MANUFACTURED IN GRAFTON, WV. DYNA-TECH ADHESIVES - DYTAC 2105 AS MANUFACTURED IN GRAFTON, WV. MINOXIDIL AS MANUFACTURED IN MILAN, ITALY.

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4Q2012EXCEL DMF# 17271 A 17272 A 17273 I 17274 A 17275 A 17276 17277 17278 17279 17280 A 17281 17282 17283 17284 17285 17286 17287 17288 17289 17290 17291 17292 17293 I 17294 17295 17296 17297 A 17298 A 17299 A 17300 17301 A I II II 4/3/2004 4/5/2004 SHISEIDO CO LTD BASIC PHARMA CHEM III 3/31/2004 PRESSPART GMBH CO KG III 3/30/2004 AMPACET CORP I A A II III III III 3/15/2004 3/29/2004 3/29/2004 3/30/2004 APOTECNIA SA POLYONE CORP POLYONE CORP AMPACET CORP A A A A A A A I A A I I III III III III II II II II II II II II II 3/29/2004 3/29/2004 3/29/2004 3/29/2004 3/25/2004 4/2/2004 4/6/2004 4/6/2004 4/6/2004 4/2/2004 3/19/2004 3/16/2004 3/12/2004 POLYONE CORP POLYONE CORP POLYONE CORP POLYONE CORP MALLINCKRODT INC CADILA HEALTHCARE LTD MYLAN LABORATORIES LTD SUN PHARMACEUTICAL INDUSTRIES LTD SUN PHARMACEUTICAL INDUSTRIES LTD PIRAMAL HEALTHCARE LTD RECORDATI ESPANA SL APOTECNIA SA RECORDATI ESPANA SL A A I A IV II II II II 4/5/2004 3/24/2004 3/31/2004 3/31/2004 4/2/2004 MANE INC LUPIN LTD DOCTOR REDDYS LABORATORIES LTD UQUIFA MEXICO SA DE CV POLYCARBON INDUSTRIES INC IV 3/25/2004 WILD FLAVORS INC IV 3/25/2004 WILD FLAVORS INC IV 3/25/2004 WILD FLAVORS INC IV 3/25/2004 WILD FLAVORS INC STATUS Type SUBMIT DATE IV 3/25/2004 HOLDER WILD FLAVORS INC SUBJECT

4Q2012

NATURAL BANANA FLAVOR WONF #FAFH080 (ALSO REFERRED TO AS #471608) AS MANUFACTURED IN ERLANGER, KY. NATURAL GRAPE FLAVOR WONF #FAFH082 (ALSO REFERRED TO AS #471477) AS MANUFACTURED IN ERLANGER, KY. NATURAL GRAPE TYPE FLAVOR #FAFH083 (ALSO REFERRED TO AS #800715) AS MANUFACTURED IN ERLANGER, KY. NATURAL BANANA FLAVOR WONF #FAFH079 (ALSO REFERRED TO AS #208830) AS MANUFACTURED IN ERLANGER, KY. NATURAL BANANA TYPE FLAVOR #FAFH078 (ALSO REFERRED TO AS #203410) AS MANUFACTURED IN ERLANGER, KY. MINT FLAVOR E_0325609 AS MANUFACTURED IN BAR-SUR-LOUP, FRANCE. CEPHALEXIN USP AS MANUFACTURED IN MADHYA PRADESH, INDIA. ESOMEPRAZOLE MAGNESIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CIPROFLOXACIN AS MANUFACTURED IN MORELOS, MEXICO. PCI-8001 (1,2-BENZISOXAZOLE-3-METHANESULFONAMIDE) AS MANUFACTURED IN LEOMINSTER, MA. CC10022488WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL. CC00014040WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL. CC00007232WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL. CC00007234WE AS MANUFACTURED IN ST. PETERS, MO. HYDROCODONE POLISTIREX (ESUB) AS MANUFACTURED IN ST. LOUIS, MO. PAROXETINE HYDROCHLORIDE, ANHYDROUS AS MANUFACTURED IN GUJARAT, INDIA. LORATADINE USP (LDP) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. GLIMEPIRIDE AS MANUFACTURED IN GUJARAT, INDIA. RIVASTIGMINE TARTRATE AS MANUFACTURED IN MAHARASHTRA, INDIA. KETOCONAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN BENIEL (MURCIA), SPAIN. ITRACONAZOLE AS MANUFACTURED IN BENIEL (MURCIA), SPAIN. PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN BENIEL (MURCIA), SPAIN. FLUCONAZOLE AS MANUFACTURED IN BENIEL (MURCIA), SPAIN. CC10007232WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL. CC10007234WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL. 16869-A BLUE (ALCAN CODE WF2804) POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA. 11078-K LAMINATE 78 POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA. RESPIMAT(R) ALUMINUM CYLINDER AS MANUFACTURED IN MARSBERG (BREDELAR), GERMANY. CAPCELL C18 AS MANUFACTURED IN SHIZUOKA, JAPAN. CHLORHEXIDINE GLUCONATE (BP) AS MANUFACTURED IN GUJARAT, INDIA.

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4Q2012EXCEL DMF# 17302 A 17303 17304 I 17305 17306 C 17307 17308 I 17309 I 17310 17311 17312 17313 17314 17315 17316 17317 17318 17319 A 17320 A 17321 17322 A 17323 17324 A 17325 A 17326 17327 17328 17329 17330 17331 A 17332 A IV 4/21/2004 TAKASAGO INTERNATIONAL CORP A A A A A II II II II II IV 4/19/2004 4/26/2004 4/23/2004 4/27/2004 4/22/2004 4/21/2004 FORMOSA LABORATORIES INC ESTEVE QUIMICA SA HOVIONE FARMACIENCIA SA QUIMICA SINTETICA SA CIPLA LTD TAKASAGO INTERNATIONAL CORP II 4/20/2004 A V II 8/6/2004 4/19/2004 I II III 4/16/2004 3/25/2004 II 5/7/2004 A A A I A A I A A II II II III III III II II II II 3/31/2004 4/1/2004 4/20/2004 3/15/2004 4/15/2004 4/15/2004 4/12/2004 4/15/2004 4/9/2004 4/13/2004 LUPIN LTD MALLINCKRODT INC SCINOPHARM TAIWAN LTD CONTINENTALAFA DISPENSING CO BRASKEM AMERICA INC DOW CHEMICAL CO ZINCOLLIED (INDIA) CIPLA LTD LEK PHARMACEUTICALS DD II 4/7/2004 A II II 4/16/2004 4/6/2004 BAYER SCHERING PHARMA AG KUNSHAN DOUBLE CRANE PHARMACEUTICAL CO LTD ARCHER DANIELS MIDLAND COMPANY NORGESTREL AS MANUFACTURED IN BERLIN AND BERGKAMEN, GERMANY. OFLOXACIN AS MANUFACTURED IN JIANGSU, CHINA. A II II 4/9/2004 4/12/2004 MYLAN LABORATORIES LTD A II II 4/2/2004 4/8/2004 STATUS Type SUBMIT DATE II 3/18/2004 HOLDER SHANDONG XINHUA PHARMACEUTICAL CO LTD DIPHARMA FRANCIS SRL SANOFI CHIMIE SUBJECT IRISQUINONE AS MANUFACTURED IN SHANDONG, CHINA. ZONISAMIDE AS MANUFACTURED IN MERETO DI TOMBA (UD), ITALY.

4Q2012

HYDROXY ACID AS MANUFACTURED IN VERTOLAYE AND NEUVILLE-SUR-SAONE CEDEX, FRANCE. CIPROFLOXACIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

ZHEJIANG HISUN PHARMACEUTICAL CO LTD ADENOSINE USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

SIO/BXR REFINED SOYBEAN OIL AS MANUFACTURED IN SAINT LAURENT-BLANGY CEDEX, FRANCE. LOVASTATIN AS MANUFACTURED IN MAHARASHTRA, INDIA. CHLORPHENIRAMINE (ESUB) AS MANUFACTURED IN ST. LOUIS, MO. IRINOTECAN HYDROCHLORIDE AS MANUFACTURED IN TAIWAN, R.O.C. DISPENSING PUMPS AS MANUFACTURED IN FOREST CITY, NC. POLYPROPYLENE PRODUCTS AS MANUFACTURED IN FREEPORT, TX. SARAN* PRODUCTS AS MANUFACTURED IN FREEPORT, TX. ZINC OXIDE AS MANUFACTURED IN DAMAN, INDIA. SERTRALINE HYDROCHLORIDE (FORM II) (ESUB) AS MANUFACTURED IN PUNE, INDIA. TAMSULOSIN HYDROCHLORIDE AS MANUFACTURE IN MENGES, SLOVENIA.

UNION QUIMICO FARMACEUTICA SA UQUIFA LABETALOL HYDROCHLORIDE AS MANUFACTURED IN MILAN, ITALY. SA NOF CORP DOPS-NA (DIOLEOYL PHOSPHATIDYLSERINE, SODIUM SALT) AS MANUFACTURED IN HYOGO, JAPAN. KV PHARMACEUTICAL CO DESTAB(TM) FERROUS FUMARATE 90 S ULTRA AS MANUFACTURED IN ST. LOUIS, MO. BOEHRINGER INGELHEIM MICROPARTS GMBH BOEHRINGER INGELHEIM FREMONT INC CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTD MYLAN LABORATORIES LTD RESPIMAT(R) INHALER AS MANUFACTURED IN DORTMUND, GERMANY. ABGENIX PRODUCTION FACILITIES IN FREMONT, CA. AMOXICILLIN AS MANUFACTURED IN HEBEI, P.R. CHINA. SERTRALINE HYDROCHLORIDE USP (FORM II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. BALSALAZIDE AS MANUFACTURED IN TAOYUAN, TAIWAN. LEVETIRACETAM AS MANUFACTURED IN TARRAGONA, SPAIN. 17ST75030 AS MANUFACTURED IN LOURES, PORTUGAL. LANZOPRAZOLE AS MANUFACTURED IN MADRID, SPAIN. TERBINAFINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN PUNE, INDIA. TAK-020184 MICRON(R) ARTIFICIAL MENTHOL FLAVOR AS MANUFACTURED IN TETERBORO, NJ. TAK-022173 MICRON(R) NATURAL & ARTIFICIAL MENTHOL FLAVOR AS MANUFACTURED IN TETERBORO, NJ.

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4Q2012EXCEL DMF# 17333 A 17334 17335 17336 17337 17338 17339 17340 17341 I 17342 I 17343 17344 17345 17346 17347 17348 I 17349 17350 17351 17352 17353 17354 A 17355 17356 I 17357 17358 17359 17360 A 17361 17362 I 17363 I 17364 A II 2/20/2004 IV 5/3/2004 N IV 5/3/2004 NOT AN ASSIGNED NUMBER FONA INTERNATIONAL INC A A A II II III II 4/22/2004 5/5/2004 5/3/2004 6/23/2004 PIERRE FABRE MEDICAMENT CADILA HEALTHCARE LTD AICELLO CHEMICAL CO LTD MALLINCKRODT INC A II II 4/26/2004 4/29/2004 SCI PHARMTECH INC SIGMA ALDRICH CO I A I A A II II II II II III 5/3/2004 5/6/2004 4/29/2004 4/29/2004 4/27/2004 4/22/2004 PROCOS SPA MYLAN LABORATORIES LTD ERREGIERRE SPA MOEHS IBERICA SL LUPIN LTD FENOPLAST LTD A I I A A II IV II II II II 3/6/2004 4/23/2004 4/22/2004 4/5/2004 4/29/2004 5/13/2004 ANQIU LUAN PHARMACEUTICAL CO LTD BIO INVIGOR CORP IPCA LABORATORIES LTD INKE SA SYNKEM SAS CHEMWERTH INC III 4/21/2004 CLARIANT (CANADA) INC I A I I I I I II II II II III III III III 4/28/2004 4/15/2004 4/12/2004 4/22/2004 4/28/2004 5/3/2004 4/28/2004 4/21/2004 STATUS Type SUBMIT DATE II 4/26/2004 HOLDER SHANGHAI ZIYUAN PHARMACEUTICAL CO LTD RANBAXY LABORATORIES LTD SAFC BIOSCIENCES INC TAIHO PHARMACEUTICAL CO LTD ASTELLAS PHARMA INC ROHM AND HAAS CO ROHM AND HAAS CO ROHM AND HAAS CO CLARIANT (CANADA) INC SUBJECT

4Q2012

FOSPHENYTOIN SODIUM USP AS MANUFACTURED IN SHANGHAI, CHINA FOR CHEMWERTH INC CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN MADHYA PRADESH, INDIA. EX-CELL(TM) 302, CHO, SERUM-FREE MEDIUM AS MANUFACTURED IN DENVER, PA. IPD-1151T DRUG SUBSTANCE AS MANUFACTURED IN SAITAMA, JAPAN. FK330 DRUG SUBSTANCE AS MANUFACTURED IN HYOGO AND OSAKA, JAPAN. ADHESIVE E-2723LV AS MANUFACTURED IN CROYDON, PA. ROSBOND PS-67LV AS MANUFACTURED IN CROYDON, PA. ADHESIVE E-2723RG AS MANUFACTURED IN CROYDON, PA. WHITE CLARIANT MASTERBATCH 01MPG-090 AS MANUFACTURED IN TORONTO AND QUEBEC, CANADA. WHITE CLARIANT MASTERBATCH 01VFV-110 AS MANUFACTURED IN TORONTO AND QUEBEC, CANADA. ACETAMINOPHEN AS MANUFACTURED IN SHANDONG PROVINCE, CHINA. BIODEGRADABLE POLYMERS AS MANUFACTURED IN TAIPEI, TAIWAN. PENTOXIFYLLINE AS MANUFACTURED IN MADHYA PRADESH, INDIA. GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN BARCELONA, SPAIN. CICLOPIROX AS MANUFACTURED IN CHENOVE, FRANCE. IRINOTECAN HCL (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN JIANGSU, CHINABY JIANHSU HENGRUI MEDICINE CO. LTD FOR CHEMWERTH. DIVALPROEX SODIUM AS MANUFACTURED IN NOVARA, ITALY. CLARITHROMYCIN USP(COP) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. GABAPENTIN AS MANUFACTURED IN BERGAMO, ITALY. SUMATRIPTANE SUCCINATE AS MANUFACTURED IN BARCELONA, SPAIN. LOVASTATIN USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. RIGID PVC FILM & PVC/PVDC COMPOSITE FILM AS MANUFACTURED IN ANDHRA PRADESH, INDIA. PROBUCOL AS MANUFACTURED IN TAOYUAN, TAIWAN. STEMLINE(TM) II HEMATOPOIETIC STEM CELL EXPANSION MEDIUM AS MANUFACTURED IN ST. LOUIS, MO. VINFLUNINE DITARTRATE AS MANUFACTURED IN GAILLAC CEDEX, FRANCE. MELOXICAM AS MANUFACTURED IN GUJARAT, INDIA. CLEAN BAG (FB01, KB02, KC04 AND FA12) AS MANUFACTURED IN AICHI, JAPAN. OPTIMARK(R) (GADOVERSETAMIDE INJECTION) PARAMETRIC RELEASE (ESUB) AS MANUFACTURED IN RALEIGH, NC.

926.029 NOR-VAN POWDER (A NATURAL & ARTIFICIAL FLAVOR) AS MANUFACTURED IN CAROL STREAM, IL. FONA INTERNATIONAL INC 863.002 N-C NATURAL LEMON-LIME FLAVOR (WONF) AS MANUFACTURED IN CAROL STREAM, IL. CHANGZHOU SIYAO PHARMACEUTICALS CO CYPROHEPTADINE HYDROCHLORIDE AS MANUFACTURED IN JIANGSU, CHINA. LTD

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4Q2012EXCEL DMF# 17365 I 17366 17367 17368 17369 17370 I 17371 I 17372 17373 I 17374 17375 A 17376 17377 I 17378 I 17379 17380 17381 17382 17383 A 17384 17385 17386 17387 17388 A 17389 17390 A 17391 A 17392 17393 17394 17395 17396 A A A A A II II II II II 5/18/2004 5/17/2004 5/18/2004 5/19/2004 5/25/2004 SCINOPHARM TAIWAN LTD CONCORD BIOTECH LTD TEVA PHARMACEUTICAL INDUSTRIES LTD FARMABIOS S P A CIPLA LTD IV 5/18/2004 INEOS USA LLC A III IV 5/11/2004 5/18/2004 A N A A II III II 5/20/2004 5/10/2004 5/17/2004 II 5/17/2004 YANGZHOU PHARMACEUTICAL CO LTD NOT AN ASSIGNED NUMBER CATALENT PHARMA SOLUTIONS LLC STELLA KUNSTSTOFFTECHNIK GMBH MINSHENG GROUP SHAOXING PHARMACEUTICAL CO LTD 3M DRUG DELIVERY SYSTEMS BP AMOCO CHEMICALS A A I A III III III II III 5/14/2004 5/14/2004 5/11/2004 5/17/2004 5/11/2004 DYNIC USA CORP DYNIC USA CORP ROLLPRINT PACKAGING PRODUCTS INC HUASHU PHARMACEUTICAL CORP ALUBERG SPA III 5/11/2004 CLARIANT (CANADA) INC I III III 5/13/2004 5/11/2004 A II II 5/13/2004 5/13/2004 I II II 5/12/2004 5/10/2004 S.A. AJINOMOTO OMNICHEM N.V. CILOSTAZOL AS MANUFACTURED IN WETTEREN, BELGIUM. II 4/16/2004 THERAGENICS CORP I A A A II II IV II III 5/10/2004 5/5/2004 4/22/2004 5/6/2004 5/5/2004 DR REDDYS LABORATORIES LTD CHEMO IBERICA SA MADRID DAH FENG CAPSULE INDUSTRY CO LTD SANDOZ INDUSTRIAL PRODUCTS GMBH CCC PLASTICS MELOXICAM AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ISRADIPINE AS MANUFACTURED IN MADRID, SPAIN. STATUS Type SUBMIT DATE II 5/7/2004 HOLDER ELAN DRUG DELIVERY INC SUBJECT

4Q2012

N1486 NANOCRYSTAL(R) TABLET CORES AS MANUFACTURED IN KING OF PRUSSIA, PA.

EMPTY GELATIN CAPSULE (HARD SHELL) AS MANUFACTURED IN TAICHUNG, TAIWAN. VICA, PURE (3-VINYL-ACA) AS MANUFACTURED IN FRANKFURT, GERMANY. WHITE MB50-926 POLYPROPYLENE COLOUR CONCENTRATE AS MANUFACTURED IN ONTARIO, CANADA. GALLIUM CHLORIDE GA-67 (BULK) RADIOCHEMICAL AS MANUFACTURED IN BUFORD, GA.

ZHEJIANG HISUN PHARMACEUTICAL CO LTD CHLORAMPHENICOL HEMISUCCINATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. EUTICALS SPA FLUDARABINE PHOSPHATE AS MANUFACTURED IN VARESE, ITALY. ORCHID CHEMICALS AND PHARMACEUTICALS LTD LORMAC INDUSTRIAL DISTRIBUTORS LTD CLARIANT (CANADA) INC CEFPROZIL AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA. LORMAC TYPE 20 POLYETHYLENE BAGS AS MANUFACTURED IN CORK, IRELAND. RED CLARIANT MASTERBATCH 20PP-1396 AS MANUFACTURED IN ONTARIO AND QUEBEC, CANADA. RED CLARIANT MASTERBATCH 02EHD-1870 AS MANUFACTURED IN ONTARIO AND QUEBEC, CANADA. HL21 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR. NK21 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR. RPP# 17-1006 AS MANUFACTURED IN ADDISON, IL AND BLOOMFIELD, CT. NEOMYCIN SULFATE AS MANUFACTURED IN SHIJIAZHUANG, CHINA. COLD FORMABLE-LAMINATED ALUMINIUM FOIL DRUG PACKAGING MATERIALS AS MANUFACTURED IN BERGAMO, ITALY. ISRADIPINE (USP26) AS MANUFACTURED IN JIANGSU, CHINA. ZEMPLAR (PARACALCITOL) CAPSULES, 1 MCG AS MANUFACTURED IN SOMERSET, NJ. REDIPAC/MO-DO-CO, 1 ML, WHITE/WHITE AS MANUFACTURED IN ELTVILLE, GERMANY. NITROFURAZONE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. COTRAN(TM) 9715 AS MANUFACTURED IN BROOKINGS, SD. INDOPOL(R) POLYBUTENE PRODUCTS AS MANUFACTURED IN LAVERA, FRANCE AND WHITING, IN. PANALANE(R) POLYBUTENE PRODUCTS AS MANUFACTURED IN LAVERA, FRANCE AND WHITING, IN. OMEPRAZOLE AS MANUFACTURED IN TAIWAN, R.O.C. LOVASTATIN USP AS MANUFACTURED IN AHMEDABAD, INDIA. IRBESARTAN AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. FLUOCINOLONE ACETONIDE AS MANUFACTURED IN GROPELLO CAIROLI, ITALY. CLOPIDOGREL BISULPHATE (ESUB) AS MANUFACTURED IN PUNE, INDIA.

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4Q2012EXCEL DMF# 17397 A 17398 17399 A 17400 A 17401 17402 17403 A 17404 A 17405 17406 17407 A 17408 17409 17410 17411 17412 I 17413 17414 17415 17416 17417 17418 A 17419 17420 A 17421 17422 A 17423 17424 17425 17426 17427 I 17428 I III 5/17/2004 HUMPHREY COSBURN PLASTICS N I A I II III III III 6/10/2004 5/11/2004 5/24/2004 5/18/2004 A II II 4/22/2004 5/9/2004 BASF SE ZHEJIANG TIANTAI PHARMACEUTICAL CO LTD NOT AN ASSIGNED NUMBER UOP LLC 3M DRUG DELIVERY SYSTEMS ROHM AND HAAS CO HUMPHREY COSBURN PLASTICS N III 5/21/2004 NOT AN ASSIGNED NUMBER BORMIOLI ROCCO AND FIGLIO SPA A I A A I II IV II II II II 5/26/2004 5/27/2004 5/24/2004 5/25/2004 5/21/2004 5/26/2004 SIGNA SA DE CV HAYASHIBARA CO LTD EXCELLA GMBH LG LIFE SCIENCES UQUIFA ITALIA SPA CAMBRIDGE ISOTOPE LABORATORIES INC I I I A II IV III II III 5/31/2004 5/28/2004 5/14/2004 5/24/2004 5/24/2004 DAI ICHI KARKARIA LTD AUTHENTIX INC CLARIANT AUSTRALIA PTY LTD SUMITOMO CHEMICAL CO LTD RITE SYSTEMS I I II II II 5/17/2004 5/28/2004 5/27/2004 ZACH SYSTEM SPA POLYCARBON INDUSTRIES INC ERIOCHEM SA IV 5/17/2004 A A II III III 5/20/2004 5/11/2004 5/10/2004 II 5/19/2004 A II II 5/24/2004 5/20/2004 INCELL CORP LLC CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD SMS PHARMACEUTICALS LTD 3M DRUG DELIVERY SYSTEMS BOEHRINGER INGELHEIM MICROPARTS GMBH NOF CORP M3(TM) CELL CULTURE MEDIA AS MANUFACTURED IN SAN ANTONIO, TX. RAPAMYCIN AS MANUFACTURED IN TAIWAN, R.O.C. CARISOPRODOL AS MANUFACTURED IN TAIWAN, R.O.C. RAMIPRIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA. COTRAN(TM) 9712 AS MANUFACTURED IN BROOKINGS, SD. STATUS Type SUBMIT DATE II 5/25/2004 HOLDER CIPLA LTD SUBJECT SUMATRIPTAN SUCCINATE (ESUB) AS MANUFACTURED IN RAIGAD, INDIA.

4Q2012

PLASTIC CAP WITH INTEGRATED SEALING RING FOR THE USE WITH RESPIMAT(R) INHALER CARTRIDGE AS MANUFACTURED IN DORTMUND, GERMANY. REFINED EGG YOLK PHOSPHATIDYLCHOLINE; COATSOME NC-50 AS MANUFACTURED IN HYOGO, JAPAN. CARVEDILOL AS MANUFACTURED IN BARCELONA, SPAIN. DISULFIRAM USP AS MANUFACTURED IN LEOMINSTER, MA. VINDOLINE AND CATHARANTHINE MIXTURE (VYC) AS MANUFACTURED IN ENTRE RIOS, ARGENTINA. TRAMADOL HYDROCHLORIDE EP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. PROPRIETARY MARKERS AS MANUFACTURED IN ADDISON, TX. REMAFIN WHITE L1071 AS MANUFACTURED IN AUSTRALIA. SNK-860 AS MANUFACTURED IN JAPAN. LIQUID COLOR-NQT-BR1230-1 AS MANUFACTURED IN WEST CHICAGO, IL; STATESVILLE, NC AND CITY OF INDUSTRY, CA. DIDEOXYINOSINE AS MANUFACTURED IN TOLUCA, MEXICO. TREHALOSE AS MANUFACTURED IN OKAYAMA, JAPAN. RALOXIFENE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY. SODIUM HYALURONATE AS MANUFACTURED IN JEONBUK-DO, KOREA. DOXYLAMINE SUCCINATE USP AS MANUFACTURED IN MILAN, ITALY. OXYGEN-18 ENRICHED WATER, CIL PART NUMBER OLM-240 AS MANUFACTURED IN ANDOVER, MA. HDPE BOTTLE 240 ML AS MANUFACTURED IN CASTELGUELFO AND RIVANAZZANO, ITALY; AND SAINT SULPICE, FRANCE. DRY VITAMIN D3 100 AS MANUFACTURED IN BALLERUP, DENMARK. CLINDAMYCIN PHOSPHATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA.

UOP MOLSIV TYPE GMP-3A AS MANUFACTURED IN CHICKASAW, AL. COTRAN(TM) 9716 AS MANUFACTURED IN BROOKINGS, SD. ADCOTE 518 ADHESIVE AS MANUFACTURED IN RINGWOOD, IL. LOPROX TOTTLE 40ML-SNAP ON WITH NEW RESIN AS MANUFACTURED IN ONTARIO, CANADA. 22MM SPECIAL H FLIP TOP LOPROX CAP AS MANUFACTURED IN ONTARIO, CANADA.

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4Q2012EXCEL DMF# 17429 I 17430 I 17431 I 17432 I 17433 I 17434 I 17435 A 17436 A 17437 A 17438 I 17439 17440 17441 A 17442 17443 A 17444 17445 17446 17447 17448 A 17449 17450 17451 A 17452 A 17453 17454 17455 I A A II III III 6/7/2004 5/1/2004 5/19/2004 SANDOZ PRIVATE LTD NAN YA PLASTICS CORP USA AMPACET CORP IV 5/27/2004 PCAS I I III III IV 5/27/2004 5/27/2004 5/27/2004 ROLLPRINT PACKAGING PRODUCTS INC ROLLPRINT PACKAGING PRODUCTS INC PCAS A A I A II II II II III 6/3/2004 6/1/2004 5/27/2004 6/3/2004 6/1/2004 UQUIFA ITALIA SPA CAYMAN CHEMICAL CO FDC LTD BIOCON LTD COLORTECH INC A III III 5/27/2004 4/16/2004 CFC INTERNATIONAL ST GOBAIN PERFORMANCE PLASTICS PIGMENTED FOILS AS MANUFACTURED IN CHICAGO HEIGHTS, IL. N N II 5/27/2004 III 5/24/2004 BERRY PLASTICS CORP TAPES AND COATINGS DIV NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER SRI KRISHNA PHARMACEUTICALS LTD 1058D TYVEK/10.8# POLYETHYLENE/.0003 ALUMINUM FOIL/PRIMER/10.0# POLYETHYLEN/1.5 MIL EVA FILM AS MANUFACTURED IN HOMER, LA. III 6/1/2004 IV 6/1/2004 II 5/31/2004 II 5/25/2004 III 5/18/2004 III 5/18/2004 III 5/18/2004 III 5/18/2004 STATUS Type SUBMIT DATE III 5/18/2004 HOLDER HUMPHREY COSBURN PLASTICS SUBJECT

4Q2012

LOPROX TOTTLE 75ML-SNAP ON WITH OLD RESIN AS MANUFACTURED IN ONTARIO, CANADA. HUMPHREY COSBURN PLASTICS LOPROX TOTTLE 40ML-SNAP ON WITH OLD RESIN AS MANUFACTURED IN ONTARIO, CANADA. HUMPHREY COSBURN PLASTICS LOPROX TOTTLE 100ML - SNAP ON WITH OLD RESIN AS MANUFACTURED IN ONTARIO, CANADA. HUMPHREY COSBURN PLASTICS LOPROX TOTTLE 100ML - SNAP ON WITH NEW RESIN AS MANUFACTURED IN ONTARIO, CANADA. HUMPHREY COSBURN PLASTICS LOPROX TOTTLE 75ML - SNAP ON WITH NEW RESIN AS MANUFACTURED IN ONTARIO, CANADA. ZHEJIANG HISUN PHARMACEUTICAL CO LTD COMPACTIN (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. AUROBINDO PHARMA LTD SERTRALINE HYDROCHLORIDE CRYSTALLINE POLYMORPH FORM II AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ABITEC CORP CAPMUL(R) PG-8 (PROPYLENE GLYCOL MONOCAPRYLATE) AS MANUFACTURED IN COLUMBUS, OH. TEKNOR COLOR CO COLOR CONCENTRATE 26,880CP BLACK 50/1 AND ITS COMPOSITION AS MANUFACTURED IN HENDERSON, KY; FOUNTAIN INN, SC; JACKSONVILLE, FL; AND LODI, OH.

ACETAMINOPHEN GRANULES DC 90% (KRISOPAP 90F) AS MANUFACTURED IN A.P., INDIA.

POLYESTER C1S 8310 UV CURABLE SILICONE RELEASE COATING AS MANUFACTURED IN WORCESTER, MA. CARISOPRODOL USP AS MANUFACTURED IN MILAN, ITALY. LATANOPROST DRUG SUBSTANCE AS MANUFACTURED IN ANN ARBOR, MI. DANTROLENE SODIUM AS MANUFACTURED IN MAHARASHTRA STATE, INDIA. PRAVASTATIN SODIUM AS MANUFACTURED IN BANGALORE, INDIA. 11002-13 WHITE POLYETHYLENE CONCENTRATION AS MANUFACTURED IN MORRISTOWN, TN AND ONTARIO, CANADA. RPP# 37-1045 AS MANUFACTURED IN ADDISON, IL AND BLOOMFIELD, CT. RPP# 37-1023 AS MANUFACTURED IN ADDISON, IL AND BLOOMFIELD, CT. LACTIDE: GLYCOLIDE COPOLYMER (PLGA 50:50) AS MANUFACTURED IN ARAMON, FRANCE. LACTIDE: GLYCOLIDE COPOLYMER (PLGA 75:25) AS MANUFACTURED IN ARAMON, FRANCE. CEFPROZIL AS MANUFACTURED IN MAHARASHTRA, INDIA. RIGID PVC SHEET AS MANUFACTURED IN WHARTON, TX. 190895 BLACK AO POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; DERIDDER, LA; AND MESSANCY, BELGIUM.

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4Q2012EXCEL DMF# 17456 A 17457 17458 I 17459 17460 17461 17462 I 17463 17464 17465 17466 17467 17468 17469 17470 I 17471 I 17472 17473 17474 17475 17476 17477 17478 A 17479 17480 I 17481 I 17482 17483 17484 17485 17486 A 17487 17488 I A II II 6/24/2004 6/25/2004 A A I A II II II III II 6/22/2004 6/21/2004 6/21/2004 6/16/2004 6/22/2004 MEIJI SEIKA PHARMA CO LTD GUFIC BIOSCIENCES LTD RANBAXY LABORATORIES LTD AMCOR FLEXIBLES RAACKMANN TIANJIN ZHONGAN PHARMACEUTICAL CO LTD USV LTD TRIFARMA SPA III 6/2/2004 STEAG MICROPARTS GMBH I II II 2/7/2004 6/22/2004 A A I I A I II IV III II II III II 6/16/2004 6/7/2004 6/17/2004 6/22/2004 6/18/2004 6/18/2004 6/22/2004 INO THERAPEUTICS INC DAI ICHI KOGYO SEIYAKU CO LTD CIBA SPECIALTY CHEMICALS ALEMBIC PHARMACEUTICALS LTD AMINO CHEMICALS LTD PARAMAK CORP LEK PHARMACEUTICAL AND CHEMICAL CO DD DINESH PHARMACEUTICALS PRIVATE LTD ARCHER DANIELS MIDLAND CO II 6/17/2004 PEPTISYNTHA SA A A N N I N A II III 6/21/2004 6/16/2004 II 5/24/2004 II III 5/24/2004 6/11/2004 TAKASAGO INTERNATIONAL CORP EASTMAN CHEMICAL CO NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER S.A. AJINOMOTO OMNICHEM NV NOT AN ASSIGNED NUMBER WOCKHARDT LTD AMPACET CORP DIVALPROEX SODIUM AS MANUFACTURED IN MAHARASHTRA, INDIA. RUTHENIUM COMPLEX AS MFG IN SHIQUOKA PREFECTURE, JAPAN ELEGANTE(R) POLYMER PC247 AS MANUFACTURED IN KINGSPORT, TN. I A I II II II II 6/9/2004 6/10/2004 6/14/2004 6/14/2004 NV ORGANON IPCA LABORATORIES LTD DAIICHI SANKYO CO LTD IHARA CHEMICAL INDUSTRY CO LTD OXANDROLONE AS MANUFACTURED IN OSS, THE NETHERLANDS. LOSARTAN POTASSIUM PROCESS II AS MANUFACTURED IN RATLAM, INDIA. CS-088 DRUG SUBSTANCE AS MANUFACTURED IN KANAGAWA, JAPAN. I II II 6/7/2004 6/10/2004 PAXIS PHARMACEUTICALS ORGANICS LLC STATUS Type SUBMIT DATE II 6/8/2004 HOLDER CIPLA LTD SUBJECT IRINOTECAN HYDROCHLORIDE TRIHYDRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN BOULDER, CO.

4Q2012

17B-ESTRADIOL-3-PHOSPHATE, ACID FORM (F00152) AS MANUFACTURED IN CHICAGO, IL.

MKS-1 (AN INTERMEDIATE OF GATIFLOXACIN) AS MANUFACTURED IN SHIZUOKA, JAPAN.

AMINO ACID MIXTURE BAX-D AS MANUFACTURED IN LOUVAIN-LA-NEUVE BELGIUM

181198 AMBER POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; AND DERIDDER, LA. AFAMELANOTIDE BULK DRUG SUBSTANCE AS MANUFACTURED IN BRUSSELS, BELGIUM. NITRIC OXIDE FOR INHALATION, 800PPM AS MANUFACTURED IN PORT ALLEN, LA. DK ESTERS (SUCROSE FATTY ACID ESTERS) AS MANUFACTURED IN SHIGA, JAPAN. IRGAGUARD B5000 AS MANUFACTURED IN OSAKA, JAPAN. CILOSTAZOL AS MANUFACTURED IN GUJARAT, INDIA. GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN MARSA, MALTA. DROPPER ASSEMBLY AS MANUFACTURED IN BALTIMORE, MD. VANCOMYCIN HYDROCHLORIDE ACTIVE DRUG SUBSTANCE AS MANUFACTURED IN MENGES, SLOVENIA. ACETAMINOPHEN USP AS MANUFACTURED IN GUJARAT, INDIA. SIO/BXR REFINED OLIVE OIL AS MANUFACTURED IN SAINT LAURENT-BLANGY CEDEX, FRANCE. ALUMINUM CYLINDER FOR THE USE WITH RESPIMAT(R) INHALER CARTRIDGE AS MANUFACTURED IN DORTMUND, GERMANY. CEFDITOREN PIVOXIL DRUG SUBSTANCE AS MANUFACTURED IN JAPAN. LIDOCAINE HYDROCHLORIDE AS MANUFACTURED IN MUMBAI, INDIA. ATORVASTATIN MAGNESIUM AS MANUFACTURED IN PUNJAB, INDIA. PETP 12/ALU 7/LLDPE 60 AS MANUFACTURED IN HORSENS, DENMARK. CAFFEINE (ANHYDROUS) AS MANUFACTURED IN TIANJIN, P.R. CHINA. CARVEDILOL PH. EUR. AS MANUFACTURED IN MAHARASHTRA, INDIA. OXCARBAZEPINE AS MANUFACTURED IN MILANO, ITALY.

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4Q2012EXCEL DMF# 17489 17490 17491 17492 17493 17494 17495 17496 17497 17498 I 17499 17500 17501 17502 17503 17504 17505 17506 17507 17508 17509 17510 17511 I 17512 17513 17514 17515 17516 17517 A 17518 A 17519 17520 17521 17522 17523 A 17524 A II 7/14/2004 WOCKHARDT LTD I A A I III II II III II 7/9/2004 7/13/2004 7/13/2004 7/9/2004 7/8/2004 II 7/12/2004 CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO LTD ROHM AND HAAS CO MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD ROHM AND HAAS CO CHEMAGIS LTD A A N A I IV III II 6/28/2004 6/17/2004 7/14/2004 II II 7/6/2004 6/18/2004 SANDOZ GMBH UCB FARCHIM SA NOT AN ASSIGNED NUMBER MS ERAWAT PHARMA LTD RIBEYRON FRANCE JANSSEN PHARMACEUTICA NV EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN PITHAMPUR, INDIA. TECHNICAL FILM AS MANUFACTURED IN SAINTE SIGOLENE, FRANCE. SULBACTAM SODIUM (STERILE) AS MANUFACTURED IN TYROL, AUSTRIA. CETIRIZINE HYDROCHLORIDE AS MANUFACTURED IN SWITZERLAND. A A A I I A N A A A A I III II III II II II 6/30/2004 7/2/2004 4/23/2004 7/1/2004 7/6/2004 7/1/2004 III II II II II II 6/21/2004 6/25/2004 6/14/2004 6/29/2004 6/28/2004 6/26/2004 STATUS Type SUBMIT DATE A A A A I I I A A II III III IV III III III III III II 6/21/2004 6/16/2004 6/23/2004 6/28/2004 6/14/2004 6/14/2004 6/14/2004 6/22/2004 6/22/2004 6/23/2004 HOLDER CAMBREX CHARLES CITY INC BERRY PLASTICS CORP ALTIRA INC AUXILIUM PHARMACEUTICALS INC POLIMERI EUROPA FRANCE SNC POLIMERI EUROPA FRANCE SNC POLIMERI EUROPA FRANCE SNC FARMASERVICE SRL FARMASERVICE SRL CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD POLIMERI EUROPA FRANCE SNC FARCHEMIA SRL CODY LABORATORIES INC CAMBREX CHARLES CITY INC CAMBREX CHARLES CITY INC SYNBIAS PHARMA LTD NOT AN ASSIGNED NUMBER ACS DOBFAR SPA HETERO LABS LTD PYN SA DE CV TEVA PHARMACEUTICAL INDUSTRIES LTD DAIICHI SANKYO CO. LTD ESTEVE QUIMICA SA STERBAG(R) PACKAGING SYSTEM AS MANUFACTURED IN TRIBIANO, ITALY. IRBESARTAN (FORM A) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. BLISTER FILMS AS MANUFACTURED IN NAUCALPAN, MEXICO. CEFADROXIL AS MANUFACTURED IN MEXICO, MO. DW-908E DRUG SUBSTANCE AS MANUFACTURED IN TOKYO, JAPAN. SUBJECT TORSEMIDE AS MANUFACTURED IN CHARLES CITY, IA. PRODUCT 60110-18 PLASTIC BOTTLES AS MANUFACTURED IN MIAMI, FL. OXACYCLOHEXADECAN-2-ONE AS MANUFACTURED IN NORRISTOWN, PA. ERACLENE ML70 AS MANUFACTURED IN PORTO-TORRES, ITALY. ERACLENE MR80 AS MANUFACTURED IN PORTO-TORRES, ITALY. ERACLENE MQ70 AS MANUFACTURED IN PORTO-TORRES, ITALY.

4Q2012

ROUND HDPE BOTTLE 200 ML AS MANUFACTURED IN SERMONETA (LT), ITALY. ROUND HDPE BOTTLE 150 ML AS MANUFACTURED IN SERMONETA (LT), ITALY. LOVASTATIN AS MANUFACTURED IN TAIWAN, THE REPUBLIC OF CHINA. GREENFLEX FF55 AS MANUFACTURED IN OBERHAUSEN, GERMANY. BALSALAZIDE DISODIUM DIHYDRATE AS MANUFACTURED IN BERGAMO, ITALY. HYDROMORPHONE HYDROCHOLORIDE AS MANUFACTURED IN CODY, WY. PROPOXYPHENE HYDROCHLORIDE AS MANUFACTURED IN CHARLES CITY, IA. PROPOXYPHENE NAPSYLATE AS MANUFACTURED IN CHARLES CITY, IA. IDARUBICIN HYDROCHLORIDE AS MANUFACTURED IN DONETSK, UKRAINE.

CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN BARCELONA AND CELRA, SPAIN.

TIPIFARNIB (R115777) DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN BELGIUM AND IRELAND. PSEUDOEPHEDRINE HYDROCHLORIDE AS MANUFACTURED IN INNER MONGOLIA, CHINA. ADCOTE 37P295HV AS MANUFACTURED IN RINGWOOD, IL. RISPERIDONE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. MIRTAZAPINE USP (HEMIHYDRATE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ADCOTE 2730-2B AS MANUFACTURED IN RINGWOOD, IL. DONEPEZIL HYDROCHLORIDE (DILUTED) 25% AMORPHOUS AS MANUFACTURED IN BEER SHEVA, ISRAEL CLARITHROMYCIN USP AS MANUFACTURED IN GUJARAT, INDIA.

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4Q2012EXCEL DMF# 17525 A 17526 17527 17528 17529 A 17530 A 17531 17532 A 17533 17534 17535 17536 A 17537 A 17538 17539 17540 A 17541 17542 17543 17544 17545 I 17546 A 17547 A 17548 17549 I 17550 A 17551 17552 I 17553 I 17554 I III 7/22/2004 UNIVERSAL MEDICAP LTD III 7/22/2004 UNIVERSAL MEDICAP LTD C II III 7/20/2004 7/22/2004 III 7/15/2004 PDC PHARMACEUTICAL DEVELOPMENT CHINA CO LTD TEVA PHARMACEUTICAL INDUSTRIES LTD UNIVERSAL MEDICAP LTD A III III 6/16/2004 7/1/2004 II 7/19/2004 II 7/19/2004 A A C A II II II II II 7/1/2004 7/13/2004 7/19/2004 7/20/2004 7/19/2004 ACS DOBFAR SPA SMS PHARMACEUTICALS LTD SHASUN PHARMACEUTICALS LTD SUN PHARMACEUTICAL INDUSTRIES LTD A I II III III 7/12/2004 5/24/2004 7/16/2004 XELLIA PHARMACEUTICALS APS ROHM AND HAAS CO CAPRIHANS INDIA LTD III 6/30/2004 SCANDINAVIAN FORMULAS INC A A A IV II II II 7/9/2004 7/27/2004 7/19/2004 6/30/2004 UNGERER AND CO MONACHEM CIPLA LTD SCANDINAVIAN FORMULAS INC ARTIFICIAL GRAPE FLAVOR FI-7723 AS MANUFACTURED IN BETHLEHEM, PA. GRADE B NOMAC (ESUB) AS MANUFACTURED IN RUE DU GABIAN, MONACO. LAMIVUDINE USP (ESUB) AS MANUFACTURED IN PUNE, INDIA. I II II 7/15/2004 7/13/2004 II 7/3/2004 ZHEJIANG YONGNING PHARMACEUTICAL FACTORY. BAYER SCHERING PHARMA AG MYLAN LABORATORIES LTD N I I III III II 7/8/2004 7/9/2004 7/14/2004 NOT AN ASSIGNED NUMBER CHROMA CORP GLOBAL ADVANTAGE LLC TARO PHARMACEUTICAL INDUSTRIES LTD STATUS Type SUBMIT DATE II 7/13/2004 HOLDER MYLAN LABORATORIES LTD SUBJECT

4Q2012

VENLAFAXINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

PC56252B 33/1 BLUE COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, IL. PVC PACKAGING MATERIAL AS MANUFACTURED IN ELKTON, MD. HALOBETASOL PROPIONATE, MICRONIZED AS MANUFACTURED IN HAIFA BAY, ISRAEL. 3990 ACID, PHARMACEUTICAL INTERMEDIATE AS MANUFACTURED IN ZHEJIANG PROVINE, CHINA. ASOPRISNIL AS MANUFACTURED IN BERLIN, GERMAY. LEVOFLOXACIN USP (HEMIHYDRATE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

SPB11(TM) (SODIUM PHENYLBUTYRATE) 1-GRAM TABLETS AS MANUFACTURED IN SOUTH PLAINFIELD, NJ. PACKAGING MATERIAL FOR SPB11(TM) (SODIUM PHENYLBUTYRATE) 1-GRAM TABLETS AS MANUFACTURED IN SOUTH PLAINFIELD, NJ. GRAMICIDIN, USP AS MANUFACTURED IN BUDAPEST, HUNGARY. COREACTANT T-8384 AS MANUFACTURED IN RINGWOOD, IL. COVER PVC AND PVDC-COATED PVC FILM PRODUCTS PACKAGING MATERIAL AS MANUFACTURED IN NASIK, INDIA. CEFTRIAXONE SODIUM, ORAL GRADE AS MANUFACTURED IN MILANO, ITALY. RANITIDINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. GABAPENTIN AS MANUFACTURED IN CUDDALORE, INDIA. FLUTICASONE PROPIONATE E//BP AS MANUFACTURED IN GUJARAT, INDIA.

UNION QUIMICO FARMACEUTICA SA UQUIFA MODAFINIL AS MANUFACTURED IN MILANO, ITALY. SA SANDOZ INDUSTRIAL PRODUCTS GMBH STERILE BULK MIXTURE AMPICILLIN/SULBACTAM FOR INJECTION AS MANUFACTURED IN FRANKFURT, GERMANY. TIANJIN TIANYAO PHARMACEUTICALS CO METHYLPREDNISOLONE USP AS MANUFACTURED IN TIANJIN, CHINA. LTD BERRY PLASTICS CORP PRODUCT 41763-43 AS MANUFACTURED IN COLUMBUS, GA VALOIS SAS METHODS FOR CONTROLLING VALOIS PACKAGING COMPONENTS AS MANUFACTURED IN VAL DE REUIL, FRANCE PACKAGING MATERIALS AND COMPONENTS FOR LARGE VOLUME PARENTERAL DRUG AND BIOLOGICAL PRODUCTS AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA. LANSOPRAZOLE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. BIOCLEAN BUTYL PHARMA RUBBER CLOSURES (NON-RFS) AS MANUFACTURED IN GUJARAT, INDIA. BIOCLEAN BUTYL PHARMA RUBBER CLOSURES (RFS) AS MANUFACTURED IN GUJARAT, INDIA. BIOCLEAN CHLOROBUTYL PHARMA RUBBER CLOSURES (NON-RFS) AS MANUFACTURED IN GUJARAT, INDIA. Page 520

4Q2012EXCEL DMF# 17555 I 17556 I 17557 I 17558 17559 A 17560 17561 17562 I 17563 17564 A 17565 17566 17567 A 17568 17569 I 17570 17571 A 17572 17573 A 17574 A 17575 17576 A 17577 A 17578 17579 17580 17581 I 17582 17583 17584 A I I II II II 7/10/2004 8/3/2004 8/2/2004 A A A IV II II II 7/30/2004 7/29/2004 7/30/2004 8/2/2004 SEPPIC SA CODY LABORATORIES INC ITF CHEMICAL LTDA LIVZON GROUP CHANGZHOU KONY PHARMACEUTICAL CO LTD CADILA PHARMACEUTICALS LTD BIOCRYST PHARMACEUTICALS INC GEDEON RICHTER LTD IV 7/30/2004 DMV FONTERRA EXCIPIENTS GMBH CO KG A II IV 7/26/2004 7/30/2004 GEDEON RICHTER PLC DMV FONTERRA EXCIPIENTS GMBH CO KG III 7/23/2004 A III II 7/15/2004 7/27/2004 A II II 7/16/2004 7/20/2004 AUROBINDO PHARMA LTD I II II 7/27/2004 7/20/2004 LEK PHARMACEUTICALS DD SHIRATORI PHARMACEUTICAL CO LTD A I II II II 7/22/2004 7/19/2004 7/22/2004 TEVA PHARMACEUTICAL INDUSTRIES LTD IPCA LABORATORIES LTD APOTEX PHARMACHEM INC A II III 7/20/2004 7/20/2004 NV ORGANON COLORTECH INC I A II II II 5/26/2004 7/23/2004 7/5/2004 MUSTAFA NEVZAT ILAC SANAYI AS FARMABIOS S P A AUROBINDO PHARMA LTD A II II 4/26/2004 4/26/2004 GLIDE CHEM PVT LTD GLIDE CHEM PVT LTD III 7/22/2004 UNIVERSAL MEDICAP LTD III 7/22/2004 UNIVERSAL MEDICAP LTD STATUS Type SUBMIT DATE III 7/22/2004 HOLDER UNIVERSAL MEDICAP LTD SUBJECT

4Q2012

BIOCLEAN CHLOROBUTYL PHARMA RUBBER CLOSURES (RFS) AS MANUFACTURED IN GUJARAT, INDIA. BIOCLEAN BROMOBUTYL PHARMA RUBBER CLOSURES (NON-RFS) AS MANUFACTURED IN GUJARAT, INDIA. BIOCLEAN BROMOBUTYL PHARMA RUBBER CLOSURES (RFS) AS MANUFACTURED IN GUJARAT, INDIA. POVIDONE IODINE AS MANUFACTURED IN HIMACHAL PRADESH, INDIA. CHLORHEXIDINE GLUCONATE SOLUTION 20% AS MANUFACTURED IN HIMACHAL PRADESH, INDIA. SULBACTAM SODIUM (NON-STERILE) AS MANUFACTURED IN KOCAELI,TURKEY. TRIAMCINOLONE DIACETATE AS MANUFACTURED IN PAVIA, ITALY. 7-AMINO DESACETOXY CEPHALOSPORANIC ACID (7-ADCA) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. NALTREXONE AS MANUFACTURED IN AK APELDOORN, THE NETHERLANDS. 11030-13 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN AND ONTARIO, CANADA. ZALEPLON AS MANUFACTURED IN DEBRECEN, HUNGARY. NABUMETONE AS MANUFACTURED IN DIST. RATLAM (MP), INDIA. MISOPROSTOL 4% DISPERSION ON HYDROXYPROPYL METHYLCELLULOSE (HPMC) AS MANUFACTURED IN ONTARIO, CANADA. SIMVASTATIN AS MANUFACTURED IN MENGES, SLOVENIA. SAPROPTERIN HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN CHIBA-KEN, JAPAN. RAMIPRIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

NINGBO GREEN-HEALTH PHARMACEUTICAL (-)-HUPERZINE A AS MANUFACTURED IN ZHEJIANG, P.R. CHINA. CO LTD RN FINK MANUFACTURING CO INC PLASTICS CONTAINERS AS MANUFACTURED IN WILLIAMSTON, MI. CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD COLORTECH INC TRANDOLAPRIL AS MANUFACTURED IN TAIWAN, R.O.C. 10001-12 ANTIBLOCK POLYETHYLENE CONCENTRATION AS MANUFACTURED IN MORRISTOWN, TN AND ONTARIO, CANADA. FINASTERIDE AS MANUFACTURED IN BUDAPEST AND DOROG, HUNGARY. PHARMATOSE(R) DCL 11 AS MANUFACTURED IN GE VEGHEL, THE NETHERLANDS AND NORTEN-HARDENBERG, GERMANY. PHARMATOSE(R) DCL 21 AS MANUFACTURED IN GE VEGHEL, THE NETHERLANDS AND NORTEN-HARDENBURG, GERMANY. SEPISPERSE DRY AS MANUFACTURED IN CASTRES CEDEX, FRANCE. FENTANYL CITRATE ACTIVE INGREDIENT AS MANUFACTURED IN CODY, WY. LEVOFLOXACIN HEMIHYDRATE AS MANUFACTURED IN BAHIA, BRAZIL. ACYCLOVIR AS MANUFACTURED IN JIANGSU, P.R. CHINA. LORATADINE USP POWDER AS MANUFACTURED IN GUJARAT, INDIA. BCX-4208 DRUG SUBSTANCE AS MANUFACTURED IN BIRMINGHAM, AL. AMLODIPINE BESYLATE AS MANUFACTURED IN BUDAPEST, HUNGARY.

Page 521

4Q2012EXCEL DMF# 17585 A 17586 I 17587 I 17588 17589 17590 17591 A 17592 17593 17594 17595 17596 A 17597 I 17598 17599 A 17600 A 17601 A 17602 A 17603 A 17604 17605 17606 17607 17608 17609 A 17610 17611 17612 A 17613 A III 8/2/2004 KIRCHNER SIMON AND CO GMBH A A II II IV 8/17/2004 8/17/2004 8/13/2004 SAFC BIOSCIENCES INC SAFC BIOSCIENCES INC UNGERER AND CO A A A A A II II II IV III II 7/31/2004 8/16/2004 8/16/2004 8/9/2004 8/13/2004 8/17/2004 AUROBINDO PHARMA LTD CADILA HEALTHCARE LTD SRI KRISHNA PHARMACEUTICALS LTD FMC BIOPOLYMER AS MULTISORB TECHNOLOGIES INC SAFC BIOSCIENCES INC II 8/16/2004 CILAG AG CLADRIBINE DRUG SUBSTANCE AS MANUFACTURED IN SCHAUFFHAUSEN, SWITZERLAND. CEPHALEXIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. II 8/13/2004 CILAG AG III 8/11/2004 ASTRA PLASTIQUE II 8/16/2004 SRI KRISHNA PHARMACEUTICALS LTD FOLIC ACID USP(ESUB) AS MANUFACTURED IN A.P., INDIA. A II II 8/12/2004 8/12/2004 RESOLUTION CHEMICALS LIMITED III 5/27/2004 CHROMA CORP A A A A III III II II III 8/2/2004 7/30/2004 8/12/2004 8/10/2004 8/10/2004 POLYONE CORP JAYCARE LTD GLENMARK GENERICS LTD CHATTEM CHEMICALS INC MEDIPHARMAPLAN CO LTD A A A II IV II III 8/5/2004 8/6/2004 8/10/2004 8/9/2004 PIRAMAL HEALTHCARE LTD SHASUN PHARMACEUTICALS LTD SUN PHARMACEUTICAL INDUSTRIES LTD APTAR RADOLFZELL GMBH III 7/23/2004 COLORTECH INC III 7/30/2004 AMPACET CORP STATUS Type SUBMIT DATE III 8/3/2004 HOLDER EXXONMOBIL CHEMICAL CO SUBJECT

4Q2012

SANTOPRENE(TM) THERMOPLASTIC RUBBER GRADE 181-57W180 AS MANUFACTURED IN AKRON, OH. 101499 DESSICANT POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; LATEXO, TX; TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; AND DERIDDER, LA. 10002-12 SLIP POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN AND ONTARIO, CANADA. BRIMONIDINE TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. HYPROMELLOSE PHTHALATE AS MANUFACTURED IN CUDDLORE, INDIA. CARVEDILOL EP/BP AS MANUFACTURED IN GUJARAT, INDIA. UNIT DOSE / BIDOSE DISPENSING SYSTEMS, MANUFACTURED IN EIGELTINGEN, GERMANY AND LE VAUDREUIL, FRANCE. CC10056380WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL. 300ML ROUND PACKER AS MANUFACTURED IN UNITED KINGDOM. GLIMEPIRIDE AS MANUFACTURED IN GUJARAT, INDIA. FENTANYL BASE AS MANUFACTURED IN CHATTANOOGA, TN. PACKAGING MATERIALS FOR I.V. SOLUTIONS AND BLOOD BAGS WITH NON PVC TUBING AND FILM AND RUBBER STOPPERS FOR INJECTION AND INFUSION PC23335 AS REQUIRED WHITE COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, IL. AZATHIOPRINE USP AS MANUFACTURED IN ZHEJIANG, CHINA.

PHARMACEUTICAL WORKS POLPHARMA SA HYDROCHLOROTHIAZIDE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND.

CLOSURE VISTOP 28 CRC AS MANUFACTURED IN SAINT-GEORGES DE RENEINS, FRANCE. SODIUM FERRIC GLUCONATE AS MANUFACTURED IN SCHAUFFHAUSEN, SWITZERLAND.

TERAZOSIN HYDROCHLORIDE ANHYDROUS AS MANUFACTURED IN GUJARAT, INDIA. ACETAMINOPHEN GRANULES DC 90% AS MANUFACTURED IN HYDERABAD, INDIA. CHITOSAN (TRADE NAME PROTASAN(TM)) AS MANUFACTURED IN OSLO, NORWAY. MULTIFORM(TM) CSF AS MANUFACTURED IN BUFFALO, NY. EX-CELL(TM) 302, CHO, SERUM-FREE MEDIUM(MODIFIED) AS MANUFACTURED IN DENVER, PA. EX-CELL(TM) 302, MEDIUM, SERUM-FREE MEDIUM AS MANUFACTURED IN DENVER, PA. ISCOVE'S MODIFIED DULBECCO'S MEDIUM (IMDM) AS MANUFACTURED IN DENVER, PA. NATURAL & ARTIFICIAL PEPPERMINT FLAVOR FM-4134 AS MANUFACTURED IN BETHLEHEM, PA. D55-31011, CAP MADE OF PHENOLIC RESIN WITH PE CONE LINER AS MANUFACTURED IN OESTRICH-WINKEL, GERMANY.

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4Q2012EXCEL DMF# 17614 A 17615 A 17616 I 17617 17618 17619 A 17620 17621 17622 17623 A 17624 17625 I 17626 17627 17628 17629 17630 I 17631 A 17632 I 17633 17634 17635 17636 17637 17638 17639 A 17640 A 17641 I 17642 A 17643 17644 I I IV IV 8/20/2004 8/20/2004 CAPSUGEL CAPSUGEL IV 8/20/2004 PFIZER INC IV 8/20/2004 CAPSUGEL IV 8/20/2004 CAPSUGEL DIV PFIZER INC A A N N N A II II 8/18/2004 10/6/2004 II III 8/30/2004 8/12/2004 CIPLA LTD WIPAK OY NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER AUROBINDO PHARMA LTD NANOTHERAPEUTICS INC ZIDOVUDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. III 8/23/2004 RITE SYSTEMS II 8/26/2004 LABORATORIOS MIRET SA A A A I II II II II III 8/26/2004 9/29/2004 8/17/2004 8/27/2004 8/16/2004 UNIMARK REMEDIES LTD ACS DOBFAR SPA ACS DOBFAR SPA MALLINCKRODT INC SUMMIT PACKAGING SYSTEMS INC A II II 8/24/2004 8/16/2004 EXCELLA GMBH KYONGBO PHARMACEUTICAL CO LTD N I A II II III 8/16/2004 8/24/2004 8/23/2004 NOT AN ASSIGNED NUMBER AJINOMOTO CO INC HETERO DRUGS LTD APTAR FRANCE SAS ADENOSINE AS MANUFACTURED IN YOKKAICHI, JAPAN. TRANDOLAPRIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA. A A III II III 8/19/2004 8/20/2004 8/20/2004 IV 8/19/2004 II 4/8/2004 NORTH CHINA PHARMACEUTICAL GROUP CORP DEGUSSA FLAVORS & FRUIT SYSTEMS US LLC MULTISORB TECHNOLOGIES LTD TARO PHARMACEUTICAL INDUSTRIES LTD MITSUBISHI GAS CHEMICAL CO INC STATUS Type SUBMIT DATE II 8/18/2004 HOLDER PARTICLE DYNAMICS INC SUBJECT

4Q2012

DESTAB(TM) CALCIUM CARBONATE 95S ULTRA 250 AS MANUFACTURED IN LITCHFIELD, MN. DEMECLOCYCLINE HYDROCHLORIDE AS MANUFACTURED IN SHIJIAZHUANG, CHINA. ARTIFICIAL FRUIT PUNCH FLAVOR (120-00219) AS MANUFACTURED IN CINCINNATI, OH AND BRIDGEPORT, NJ. DRI-MAC(TM) DESICCANT CANISTER AS MANUFACTURED IN SHROPSHIRE, ENGLAND. FLUTICASONE PROPIONATE, MICRONIZED AS MANUFACTURED IN HAIFA BAY, ISRAEL. OXYGEN ABSORBER PHARMAKEEP(R) INGREDIENT TYPE GKH AS MANUFACTURED IN SAITAMA PREF., JAPAN.

APTAR METHODS FOR CONTROLLING PACKAGING COMPONENTS AS MANUFACTURED IN LE VAUDREUIL, FRANCE AND CONGERS, NEW YORK ALFUZOSIN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY. BACAMPICILLIN HYDROCHLORIDE NON-STERILE, BULK AS MANUFACTURED IN CHUNGCHEONG NAM-DO, KOREA. LISINOPRIL USP AS MANUFACTURED IN MUMBAI, INDIA. STERILE SODIUM CARBONATE AS MANUFACTURED IN BRAZIL FOR ACS DOBFAR SPA. CEFTAZIDIME DIHYDROCHLORIDE AS MANUFACTURED IN MILANO, ITALY. DRONABINOL IN SESAME OIL AS MANUFACTURED IN ST. LOUIS, MO. AEROSOL VALVE FOR USE WITH: TBC-V (PHARMACEUTICAL OIL) AS MANUFACTURED IN MANCHESTER, NH AND RACINE, WI. ETHYL-N -DODECANOYL-L-ARGINATE HYDROCHLORIDE (LAE) AS MANUFACTURED IN BARCELONA, SPAIN. LIQUID COLOR-WHITE LQC-W1454-1 AS MANUFACTURED IN WEST CHICAGO, IL; STATESVILLE, NC; AND CITY OF INDUSTRY, CA. RIZATRIPTAN BENZOATE AS MANUFACTURED IN MAHARASHTRA, INDIA. PPP 200 INFU 13 PEEL 2 AS MANUFACTURED IN NOSTOLA, FINLAND.

TRIAPINE(R) CAPSULES AS MANUFACTURED BY METRICS INC IN GREENVILLE, NC FOR VION PHARMACEUTICALS INC. POLYSACCHARIDE EMPTY HARD CAPSULES AS MANUFACTURED IN BANGKOK, THAILAND. POLYSACCHARIDE EMPTY HARD CAPSULES AS MANUFACTURED IN BORNEM, BELGIUM. POLYSACCHARIDE EMPTY HARD CAPSULES AS MANUFACTURED IN WEST JAVA, INDONESIA. POLYSACCHARIDE EMPTY HARD CAPSULES AS MANUFACTURED IN SUZHOU, CHINA. POLYSACCHARIDE EMPTY HARD CAPSULES AS MANUFACTURED IN GREENWOOD, SC.

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4Q2012EXCEL DMF# 17645 17646 17647 17648 17649 17650 A 17651 17652 17653 17654 I 17655 I 17656 17657 17658 17659 17660 A 17661 17662 17663 I 17664 I 17665 17666 17667 17668 17669 17670 I 17671 I 17672 17673 I 17674 I II 9/27/2004 STRAINRITE I II II 8/3/2004 7/18/2004 PCAS DELTA TECH LTD SODIUM VALPROATE SOLUTION AS MANUFACTURED IN LIMAY, FRANCE. III 9/9/2004 WINPAK TECHNOLOGIES INC A N A A A II II II III 9/3/2004 9/14/2004 9/8/2004 9/8/2004 II 9/10/2004 TEVA PHARMACEUTICAL INDUSTRIES LTD NOT AN ASSIGNED NUMBER JUZEN CHEMICAL CORP CHATTEM CHEMICALS INC AMERICAN PEPTIDE CO WINPAK TECHNOLOGIES INC PRULIFLOXACIN AS MANUFACTURED IN TOYAMA PREFECTURE, JAPAN. METHYLPHENIDATE BASE AS MANUFACTURED IN CHATTANOOGA, TN. PEPTIDE 312868 (TP508) AS MANUFACTURED IN VISTA, CA. III 9/6/2004 REXAM PHARMA SAS A I II II III 9/2/2004 9/8/2004 8/27/2004 JUZEN CHEMICAL CORP LEK PHARMACEUTICALS DD AMARTARA PRIVATE LTD A A A C II II II II III 9/9/2004 8/30/2004 8/31/2004 9/8/2004 9/7/2004 II 9/7/2004 ORCHID CHEMICALS AND PHARMACEUTICALS LTD HETERO DRUGS LTD AUROBINDO PHARMA LTD LUPIN LTD TEVA PHARMACEUTICALS INDUSTRIES LTD 3M DRUG DELIVERY SYSTEMS A A A II II III III 9/2/2004 9/7/2004 9/1/2004 8/30/2004 FORMOSA LABORATORIES INC MOREPEN LABORATORIES LTD SCHOTT KAISHA PVT LTD BASF AKTIENGESELLSCHAFT STATUS Type SUBMIT DATE A A I A A II II II II II II 8/30/2004 8/31/2004 8/30/2004 8/30/2004 8/31/2004 9/2/2004 HOLDER OPOCRIN SPA CIPLA LTD YONEZAWA HAMARI CHEMICALS LTD DR REDDYS LABORATORIES LTD SHASUN PHARMACEUTICALS LTD ACCORD HEALTHCARE INC SUBJECT SODIUM FERRIC GLUCONATE AS MANUFACTURED IN MODENA, ITALY. STAVUDINE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA. L-CARNITINE AS MANUFACTURED IN YAMAGATA, JAPAN.

4Q2012

NARATRIPTAN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. SULPHAZINE AS MANUFACTURED IN CUDDALORE, INDIA. PACLITAXEL API AS MANUFACTURED IN RANCHO CORDOVA, CA FOR BIOXEL PHARMA INC COLESTIPOL HYDROCHLORIDE AS MANUFACTURED IN TAOYAUN, TAIWAN. DESLORATADINE AS MANUFACTURED IN HIMACHAL PRADESH, INDIA. AMPOULES AND VIALS AS MANUFACTURED IN NANI DAMAN, INDIA. ACRONAL(R) 3570 AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY. CEFIXIME, USP AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA. GLIMEPIRIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. DIDANOSINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. TRANDOLAPRIL AS MANUFACTURED IN MADHYA PRADESH, INDIA. CARBOPLATIN AS MANUFACTURED IN EDO DE MEXICO, MEXICO. 3M RELEASE LINER SCOTHPAK(TM) 9741 AS MANUFACTURED IN NEVADA, MO; COTTAGE GROVE AND WEST ST. PAUL, MN; DECATUR, AL; GREENVILLE, SC; AND ZWIJNDRECHT, BELGIUM. ZONISAMIDE AS MANUFACTURED IN MIE PREFECTURD, JAPAN. LOVASTATIN AS MANUFACTURED IN LJUBLJANA, SLOVENIA. NON-TOXIC PVDC COATED PVC FILM FOR PHARMACEUTICAL PACKAGING SUITABLE FOR BLISTER PACKAGING OF ORAL TABLETS AND CAPSULES AS MANUFACTURED IN MAHARASHTRA STATE, INDIA. TABLET JARS IN 60 ML AND 100 ML (WHITE COLOR) AS MANUFACTURED IN OFFRANVILLE, FRANCE. TRIMIPRAMINE MALEATE AS MANUFACTURED IN NETANYA, ISRAEL.

41.0 GSM BLEACHED PAPER MG 912/250/ 11.0 GSM PE 5050/ 24.1 GSM 9.0 UM ALUMINUM FOIL/ 0.2 GSM PRIMER 10-ZZ-2/ 12.0 GSM PE 5050 AS MANUFACTURED IN ONTARIO, CANADA. INK/ 41.0 GSM BLEACHED PAPER MG 912/250/ 11.0 GSM PE 5050/ 24.1 GSM 9.0 UM ALUMINUM FOIL/ 12 GSM PE SURLYN 1652-SR AS MANUFACTURED IN ONTARIO, CANADA.

IVERMECTIN AS MANUFACTURED IN SHANGHAI VETERINARY PHARMACEUTICAL WORKS IN SHANGHAI, CHINA FOR DELTA TECH LTD. DCM-MD-XX-630, 352000: CLARIFICATION VESSEL FOR ONE-TIME USE AS MANUFACTURED IN AUBURN, MAINE.

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4Q2012EXCEL DMF# 17675 17676 A 17677 17678 17679 17680 17681 17682 17683 17684 17685 A 17686 A 17687 17688 17689 17690 A 17691 A 17692 A 17693 A 17694 17695 17696 17697 17698 17699 17700 I 17701 17702 17703 17704 17705 17706 17707 A A A A A A A II II II III II II II 9/23/2004 9/8/2004 9/13/2004 9/20/2004 9/24/2004 9/24/2004 9/20/2004 MOREPEN LABORATORIES LTD JOST CHEMICAL CO ACIDCHEM INTERNATIONAL SDN BHD POLYONE CORP LUPIN LTD DR REDDYS LABORATORIES LTD AUROBINDO PHARMA LTD A A A A A I II II II II II II II 9/9/2004 3/11/2004 9/17/2004 9/22/2004 9/22/2004 9/19/2004 9/23/2004 NCPC HUALUAN PHARMACEUTICAL CO LTD EVONIK TECHNOCHEMIE GMBH PROMETIC BIOSCIENCES LTD MYLAN LABORATORIES LTD SARACA LABORATORIES LTD DIVIS LABORATORIES LTD CHEMWERTH INC II 9/15/2004 ARCH PHARMALABS LTD II 9/22/2004 AMRI RENSSELAER INC III 9/20/2004 PHILLIPS PLASTICS CORP I A A III II III III 9/2/2004 9/17/2004 9/16/2004 9/20/2004 BASF AKTIENGESELLSCHAFT CADILA HEALTHCARE LTD POLYONE CORP EXXONMOBIL CHEMICAL CO II 9/5/2004 CATALENT PHARMA SOLUTIONS LLC A A I A I A A I II II II II II III II II II 9/13/2004 9/15/2004 9/10/2004 9/9/2004 9/15/2004 9/13/2004 9/10/2004 9/9/2004 9/14/2004 DOTTIKON EXCLUSIVE SYNTHESIS AG SUN PHARMACEUTICAL INDUSTRIES LTD SMOPTECH LTD CIPLA LTD ASTELLAS PHARMA INC REXAM HEALTHCARE OFFRANVILLE SAS SANDOZ GMBH ISO TEX DIAGNOSTICS INC DAIICHI SANKYO CO LTD STATUS Type SUBMIT DATE A III IV 9/9/2004 9/10/2004 HOLDER DINSHI AMPOULE MAKERS PRIVATE LTD DAVID MICHAEL AND CO INC SUBJECT GLASS AMPOULES AS MANUFACTURED IN MAHARASHTRA, INDIA. MICHAELOK ARTIFICIAL STRAWBERRY FLAVOR #3220 AS MANUFACTURED IN PHILADELPHIA, PA. OLSALAZINE SODIUM AS MANUFACTURED IN DOTTIKON, SWITZERLAND. OCTREOTIDE ACETATE AS MANUFACTURED IN MAHARASHTRA, INDIA. SMOPEX-111 AS MANUFACTURED IN TURKU, FINLAND. FINASTERIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. FK555 DRUG SUBSTANCE AS MANUFACTURED IN HYOGO AND OSAKA, JAPAN.

4Q2012

BOTTLE IN 15 ML (WHITE COLOR) AS MANUFACTURED IN OFFRANVILLE, FRANCE. 7-AMCA AS MANUFACTURED IN TYROL, AUSTRIA. METHYLENE BLUE I-125 AS MANUFACTURED IN FRIENDSWOOD, TX. BENICAR(TM) TABLETS 5 MG, 20 MG AND 40 MG AS MANUFACTURED IN KANAGAWA, JAPAN. ATRASENTAN HYDROCHLORIDE, SOFT GELATIN CAPSULES, 10 MG (BASE EQUIVALENT) AS MANUFACTURED IN ST. PETERSBURG, FL. ACRONAL(R) N-CR 162 AS MANUFACTURED IN MONACA, PA. TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA. CC00017762WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL. SANTOPRENE(TM) THERMOPLASTIC RUBBER 181-XXMED AND 281-XXMED GRADE SERIES AS MANUFACTURED IN CANTONMENT, FL AND SOUTH WALES, UNITED KINGDOM. DIASTAT(R) (DIAZEPAM RECTAL GEL) RECTAL DELIVERY SYSTEM AS MANUFACTURED IN MENOMONIE, WI. AMPHETAMINE ASPARTATE, MONOHYDRATE DRUG SUBSTANCE AS MANUFACTURED IN RENSSELAER, NY. 3-(2-CHLOROPHENYL)-5-METHYL ISOXAZOLE-4-CARBONYL CHLORIDE (CMIC CHLORIDE) AS MANUFACTURED IN HYDERABAD, INDIA. 6-AMINOPENICILLANIC ACID (6-APA) AS MANUFACTURED IN HEBEI, CHINA. CHLOROHEXIDINE BASE AS MANUFACTURED IN MIDDLESBOROUGH, ENGLAND. MABSORBENT A2P AS MANUFACTURED IN ISLE OF MAN, BRITISH ISLES. CELECOXIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA. RANITIDINE HYDROCHLORIDE (FORM-II) AS MANUFACTURED IN MEDAK, INDIA. METHYLDOPA USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. METHOHEXITAL, NON-STERILE, BULK DRUG AS MANUFACTURED IN ZHEJIANG, CHINA FOR CHEMWERTH INC PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN HIMALCHAL PRADESH, INDIA. SODIUM SULFATE AS MANUFACTURED IN ST. LOUIS, MO. ISOPROPYL MYRISTATE AS MANUFACTURED IN PENANG, MALAYSIA. CC00017105DR AS MANUFACTURED IN GLENDALE, AZ. CEFDINIR AS MANUFACTURED IN MADHYA PRADESH, INDIA. OMEPRAZOLE MAGNESIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CEFUROXIME AXETIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

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4Q2012EXCEL DMF# 17708 A 17709 A 17710 17711 I 17712 17713 17714 I 17715 I 17716 I 17717 17718 17719 A 17720 A 17721 17722 17723 A 17724 A 17725 A 17726 A 17727 17728 17729 17730 17731 17732 A 17733 17734 17735 A 17736 17737 A A II II 10/6/2004 9/30/2004 DR REDDYS LABORATORIES LTD LUPIN LTD A A III II IV 9/30/2004 10/7/2004 10/5/2004 A C A A A II II II II II II 10/6/2004 9/24/2004 10/6/2004 9/30/2004 9/29/2004 7/24/2004 SUN PHARMACEUTICAL INDUSTRIES LTD AUROBINDO PHARMA LTD GLENMARK GENERICS LTD LUPIN LTD LUPIN LTD JILIN SHULAN SYNTHETIC PHARMACEUTICAL CO LTD POLYONE CORP KISSEI PHARMACEUTICAL CO LTD TOLMAR THERAPEUTICS INC IV 10/4/2004 IDEAL CURES PVT LTD IV 10/4/2004 IDEAL CURES PVT LTD II 9/30/2004 JENAHEXAL PHARMA GMBH I C II II II 9/22/2004 9/22/2004 9/22/2004 GRANULES INDIA LTD GRANULES INDIA LTD GRANULES INDIA LTD II 9/30/2004 CIPLA LTD I A II IV II 10/19/2004 9/30/2004 10/5/2004 AXCAN PHARMA INC DOW CORNING CORP SANDOZ GMBH IV 9/29/2004 FONA INTERNATIONAL INC II 9/27/2004 A A II II II 9/30/2004 9/30/2004 9/29/2004 SUN PHARMACEUTICAL INDUSTRIES LTD GLENMARK GENERICS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD STRAINRITE A III II 9/23/2004 9/29/2004 POLYONE CORP HELICON THERAPEUTICS INC III 9/9/2004 SOLVIN SA STATUS Type SUBMIT DATE II 9/14/2004 HOLDER ZHEJIANG NHU CO LTD SUBJECT

4Q2012

VITAMIN A PALMITATE/VITAMIN E OIL/SOYBEAN SALAD OIL BLEND AS MANUFACTURED IN ZHEJIANG, CHINA. DIOFAN SUPER BA AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY AND TAVAUX, FRANCE. CC10009918WE 19362WC AQUA AS MANUFACTURED IN ELK GROVE VILLAGE, IL. IPL-455,903 (HT-0712) ACTIVE PHARMACEUTICAL INGREDIENT (API) AS MANUFACTURED IN CINCINNATI, OH. ZOLPIDEM TARTRATE EP/PB AS MANUFACTURED IN GUJARAT, INDIA. PERINDOPRIL ERBUMINE AS MANUFACTURED IN GUJARAT, INDIA. CEFTRIAXONE SODIUM AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA. DCM-MD-XX-420, 352002: CLARIFICATION VESSEL FOR ONE-TIME USE AS MANUFACTURED IN AUBURN, MAINE. 857.008. N-C NATURAL GRAPEFRUIT FLAVOR (WONF) AS MANUFACTURED IN CAROL STREAM, IL. URSODIOL SUSPENSION, 250 MG/ML AS MANUFACTURED IN QUEBEC, CANADA. DOW CORNING(R) ST-CYCLOMETHICONE5-NF AS MANUFACTURED IN HEMLOCK, MI. SOMATROPIN (HUMAN GROWTH HORMONE) SANDOZ AS MANUFACTURED IN KUNDL, AUSTRIA. PANTOPRAZOLE SODIUM SESQUIHYDRATE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA. ACETAMINOPHEN AS MANUFACTURED IN HYDERABAD, INDIA. COMPRESSO PAP 90 CPF (ACETAMINOPHEN DC 90) AS MANUFACTURED IN A.P., INDIA. COMPRESSO 95 P (DIRECT COMPRESSION 95% METFORMIN HCL) AS MANUFACTURED IN A.P., INDIA. 0.9% SODIUM CHLORIDE INJECTION, USP - 1 ML/2 ML AMPOULE AS MANUFACTURED IN JENA, GERMANY. INSTAGLOW POLISHING SYSTEM FOR COATED & UNCOATED TABLETS AS MANUFACTURED IN MAHARASHTRA, INDIA. INSTACOAT COATING SYSTEMS USING COLOR DISPERSION AS MANUFACTURED IN MAHARASHTRA, INDIA. CLONAZEPAM USP AS MANUFACTRUED IN MAHARASHTRA, INDIA. HYDROCHLOROTHIAZIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. TOPIRAMATE AS MANUFACTURED IN GUJARAT STATE, INDIA. 7-APCA INTERMEDIATE (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA. CEFPROZIL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA. CAFFEINE ANHYDROUS, USP AS MANUFACTURED IN JILIN PROVINCE, P.R. CHINA. CC00002829WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL. KUR-1246 DRUG SUBSTANCE AS MANUFACTURED IN FUKUI PREFECTURE, JAPAN. POLY(DL-LACTIDE-CO-GLYCOLIDE) BIODEGRADABLE POLYMER EXCIPIENTS AS MANUFACTURED IN FORT COLLINS, CO. TOLTERODINE TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. LOVASTATIN (ESUB) TECHNICAL AS MANUFACTURED IN MAHARASHTRA, INDIA.

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4Q2012EXCEL DMF# 17738 17739 17740 17741 17742 A 17743 17744 A 17745 A 17746 A 17747 17748 A 17749 A 17750 17751 17752 17753 17754 17755 17756 17757 17758 17759 17760 17761 17762 17763 17764 A 17765 17766 A 17767 17768 17769 17770 17771 I A I I A II II III III III 10/13/2004 10/18/2004 10/18/2004 10/18/2004 10/18/2004 MALLINCKRODT INC CHEMI SPA BASF AKTIENGESELLSCHAFT BASF AKTIENGESELLSCHAFT STYROLUTION GMBH A II III 10/20/2004 10/20/2004 CIPLA LTD BILCARE LTD A A I I A A A I A A A A A A II II II II II II III III II II IV IV IV IV II 10/8/2004 10/8/2004 9/30/2004 10/14/2004 11/8/2004 10/12/2004 8/16/2004 10/11/2004 10/15/2004 10/18/2004 9/28/2004 9/28/2004 9/28/2004 9/28/2004 10/15/2004 MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD MALLINCKRODT INC DIPHARMA SPA UNIMARK REMEDIES LTD FORMOSA LABORATORIES INC ALLTUB CENTRAL EUROPE SRO DUPONT ENGINEERING POLYMERS FARMABIOS S P A FARMABIOS S P A BASF SE BASF SE BASF SE BASF SE SAFC PHARMA III 10/18/2004 TORAY PLASTICS AMERICA INC A III III 9/29/2004 10/17/2004 POLYONE CORP ETIMEX PRIMARY PACKAGING GMBH II 10/7/2004 BIOFER SPA II 10/5/2004 NOVACYL SAS A II II 10/14/2004 10/14/2004 USV LIMITED USV LIMITED STATUS Type SUBMIT DATE C A A A II II II II III 10/7/2004 10/8/2004 10/8/2004 10/8/2004 10/8/2004 HOLDER HETERO LABS LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD PACKAGING CONCEPTS ASSOC LLC SUBJECT LEVETIRACETAM (FORM 1) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ITRACONAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. LAMOTRIGINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

4Q2012

CETIRIZINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CHILD RESISTANCE (CR) SPRAY DISPENSING SYSTEM AS MANUFACTURED IN BOYNTON BEACH, FL. METFORMIN HYDROCHLORIDE DC GRANULES AS MANUFACTURED IN DAMAN, INDIA. METFORMIN HYDROCHLORIDE BP (COARSE) AS MANUFACTURED IN MAHARASHTRA, INDIA. RHODAPAP AND RHODAPAP DC PRODUCTS (ACETAMINOPHEN) AS MANUFACTURED IN WUXI, CHINA. SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION AS MANUFACTURED IN MEDOLLA, ITALY. CC10048656WE WHITE AS MANUFACTURED IN ELK GROVE VILLAGE, IL. PURELAY PHARM FG 100/E TRANSPARENT (300UM) AND PURELAY PHARM FG 100/E WHITE (300 UM) DRUG PACKAGING PACKAGE AS MANUFACTURED IN DIETENHEIM, GERMANY. TORAY'S PA10 AND PA20 MULTILAYER PET FILM PRODUCTS INTENDED FOR USE IN DRUG PACKAGING AS MANUFACTURED IN NORTH KINGSTOWN, RI. LAMIVUDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ZIDOVUDINE USP ( PROCESS-I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. MORPHINE ALKALOID, CODE 1547 (ESUB) AS MANUFACTURED IN ST. LOUIS, MO. MANDELATE SALT, INTERMEDIATE AS MANUFACTURED IN UD, ITALY. ALBENDAZOLE USP AS MANUFACTURED IN GUJARAT, INDIA. PARSOL 1789 (AVOBENZONE) AS MANUFACTURED IN TAIWAN, R.O.C. ALUMINIUM TUBES AS MANUFACTURED IN KOLIN, CZECH REPUBLIC. CRESTIN(R) 6131C NC010 AS MANUFACTURED IN MONCK'S CORNER, SC. TRIAMCINOLONE HEXACETONIDE AS MANUFACTURED IN PAVIA, ITALY. DESOXIMETASONE AS MANUFACTURED IN PAVIA, ITALY. Kolliwax(R) S Fine AS MANUFACTURED IN DUESSELDORF, GERMANY. Kolliphor(R) SLS Fine AS MANUFACTURED IN DUESSELDORF, GERMANY. Kolliphor(R) SLS AS MANUFACTURED IN DUESSELDORF, GERMANY. Kolliwax(R) S AS MANUFACTURED IN DUESSELDORF, GERMANY. TRYPAN BLUE PURIFIED MANUFACTURING IN NEW ROAD GILLINGHAM DORSET SP8 4XT U.K. LORAZEPAM (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. BILCARE SPECIALITY METALIZED, NON-METALIZED ECOFRIENDLY, MONO AND MULTILAYERED FILMS AND SUBSTRATES AS MFG IN MAHARASHTRA, INDIA PROSAPTIDE AS MANUFACTURED IN ST. LOUIS, MO. GOSERELIN ACETATE AS MANUFACTURED IN MILANO, ITALY. STYROLUX(R) 3G33 AS MANUFACTURED IN MEXICO AND BELGIUM. STYROLUX(R) 3G55 Q420 AS MANUFACTURED IN MEXICO AND BELGIUM. STYROLUX(R) 684 D AS MANUFACTURED IN MEXICO AND BELGIUM.

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4Q2012EXCEL DMF# 17772 17773 17774 17775 17776 I 17777 17778 17779 17780 17781 17782 17783 A 17784 17785 17786 17787 A 17788 17789 17790 17791 A 17792 A 17793 17794 17795 17796 17797 17798 17799 17800 17801 A 17802 17803 17804 17805 A 17806 I II 11/1/2004 A A A II II III II 10/23/2004 11/1/2004 11/2/2004 10/27/2004 A A A A I N A A II II II 11/2/2004 10/15/2004 10/29/2004 II II II II II 10/25/2004 10/25/2004 9/29/2004 10/29/2004 10/12/2004 II 10/27/2004 ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD CIPLA LTD TEVA PHARMACEUTICALS INDUSTRIES LTD DOW AGROSCIENCES LLC RANBAXY LABORATORIES LTD GADOR SA NOT AN ASSIGNED NUMBER NEULAND LABORATORIES LTD UQUIFA MEXICO SA DE CV HELSINN CHEMICALS SA HELSINN ADVANCED SYNTHESIS SA AUROBINDO PHARMA LTD CRYSTAL PHARMA SAU REXAM HEALTHCARE OFFRANVILLE SAS ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD RHODIA ORGANIQUE SAS LEVETIRACETAM AS MANUFACTURED IN ANDHRA PRADESH, INDIA. TROPICAMIDE AS MANUFACTURED IN MORELOS, MEXICO. DMSAM AS MANUFACTURED IN BLASCA, SWITZERLAND. EFAVIRENZ AS MANUFACTURED IN ANDHRA PRADESH, INDIA. I A A II II II III 10/29/2004 10/29/2004 10/29/2004 9/27/2004 A A A II III II II 10/8/2004 10/21/2004 10/22/2004 10/28/2004 FIDIA FARMACEUTICI SPA REXAM HEALTHCARE OFFRANVILLE SAS UNIQUE CHEMICALS A A A A A A II II II II II II II 10/21/2004 10/25/2004 10/26/2004 10/20/2004 10/28/2004 10/26/2004 10/26/2004 TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICALS INDUSTRIES LTD DR REDDYS LABORATORIES LTD IPCA LABORATORIES LTD ATUL LTD HETERO LABS LTD CATALENT PHARMA SOLUTIONS LLC STATUS Type SUBMIT DATE A I A I III III IV II II 10/18/2004 10/20/2004 9/15/2004 10/21/2004 10/22/2004 HOLDER STYROLUTION GMBH ROHM AND HAAS CO CRODA INC THERAGENICS CORP ELAN DRUG DELIVERY INC SUBJECT STYROLUX(R) 656 C AS MANUFACTURED IN MEXICO AND BELGIUM. ADCOTE HS 35X120 AS MANUFACTURED IN RINGWOOD, IL. SUPER REFINED OLEIC ACID NF AS MANUFACTURED IN MILL HALL, PA.

4Q2012

BULK INDIUM CHLORIDE IN-111 RADIOCHEMICAL AS MANUFACTURED IN BUFORD, GA. N1296 ORAL NANOCRYSTAL(R) COLLOIDAL DISPERSION AS MANUFACTURED IN KING OF PRUSSIA, PA. OCTREOTIDE ACETATE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. SILDENAFIL CITRATE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. BALSALAZIDE DISODIUM DIHYDRATE AS MANUFACTURED IN MUMBAI, INDIA. DAPSONE USP AS MANUFACTURED IN GUJARAT, INDIA. NEVIRAPINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. TIPRANAVIR CAPSULES 250 MG (IMPRINTED) AS MANUFACTURED IN ST. PETERSBURG, FL. BUPROPION HYDROCHLORIDE AS MANUFACTURED IN LODI, ITALY. RISPHARM EYE DROPPERS SETS AS MANUFACTURED IN OFFRANVILLE, FRANCE. CIPROFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA.

UNION QUIMICO FARMACEUTICA SA UQUIFA LANSOPRAZOLE AS MANUFACTURED IN BARCELONA, SPAIN. SA NUVELO INC ALFIMEPRASE AS MANUFACTURED IN THOUSAND OAKS, CA. SEVEN STAR PHARMACEUTICAL CO LTD TARO PHARMACEUTICAL INDUSTRIES LTD LEPTON DOO BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN TAIWAN, R.O.C. TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN HAIFA BAY, ISRAEL. B 250 204 GREY AND RED ELASTOMERIC INJECTION CLOSURES FOR PHARMACEUTICALS AS MANUFACTURED IN KRANJ, SLOVENIA FOR LEPTON D.O.O. BENAZEPRIL HYDROCHLORIDE (BULK) AS MANUFACTURED IN ZHEJIANG, CHINA. GRANISETRON HYDROCHLORIDE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA. VALACYCLOVIR HYDROCHLORIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. SPINOSAD PHARMACEUTICAL GRADE AS MANUFACTURED IN HARBOR BEACH, MI. IRBESARTAN USP AS MANUFACTURED IN PUNJAB, INDIA. VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN PILAR, ARGENTINA.

BETAMETHASONE SODIUM PHOSPHATE AS MANUFACTURED IN VALLADOLID, SPAIN. PILL JARS SETS - CRC RANGE AS MANUFACTURED IN OFFRANVILLE, FRANCE. FOSINOPRIL SODIUM (BULK) AS MANUFACTURED IN ZHEJIANG, CHINA. 4-NITRO-3-TRIFLUOROMETHYLANILINE (NTFMA) AS MANUFACTURED IN MULHOUSE, FRANCE.

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4Q2012EXCEL DMF# 17807 A 17808 17809 A 17810 17811 17812 17813 17814 A 17815 17816 17817 A 17818 A 17819 17820 I 17821 A 17822 17823 17824 17825 17826 17827 17828 17829 17830 I 17831 I 17832 I 17833 17834 A 17835 17836 17837 17838 A A A A IV II II II 11/17/2004 11/15/2004 11/18/2004 11/3/2004 GUJARAT MICROWAX PRIVATE LTD USV LIMITED CAMBRIDGE ISOTOPE LABORATORIES INC BIOIBERICA SA I II II 11/8/2004 11/16/2004 II 9/8/2004 NANTONG GENERAL PHARMACEUTICAL FACTORY MEDICHEM SA MERCK KGAA IV 11/10/2004 FONA INTERNATIONAL INC I A A A I A A A II II II II II II II II IV 11/11/2004 11/10/2004 10/30/2004 11/10/2004 11/12/2004 11/16/2004 12/15/2004 11/8/2004 11/10/2004 UQUIFA MEXICO S.A. DE C.V. HARMAN FINOCHEM LTD AUROBINDO PHARMA LTD SUN PHARMACEUTICAL INDUSTRIES LTD BOEHRINGER INGELHEIM CHEMICALS INC TEVA PHARMACEUTICALS USA INC JANSSEN PHARMACEUTICA NV AUROBINDO PHARMA LTD FONA INTERNATIONAL INC II 11/1/2004 CHEMWERTH INC A II IV 11/2/2004 11/8/2004 MOEHS IBERICA SL SHOWA DENKO KK III 11/1/2004 A A II II II 11/10/2004 11/8/2004 11/9/2004 A A A A II II II II II 11/7/2004 11/8/2004 11/3/2004 11/4/2004 10/25/2004 A II II 11/3/2004 11/3/2004 IPCA LABORATORIES LTD SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTD DIVIS LABORATORIES LTD CIPLA LTD CARBOGEN AMCIS AG CEDARBURG PHARMACEUTICALS INC NATIONAL INSTITUTES HEALTH NATIONAL CANCER INSTITUTE HELSINN ADVANCED SYNTHESIS SA ANDHRA SUGARS LTD CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO LTD COLORTECH INC STATUS Type SUBMIT DATE II 11/2/2004 HOLDER NOF CORP SUBJECT

4Q2012

DIMYRISTOYL PHOSPHATIDYL GLYCEROL SODIUM SALT (DMPG-NA) AS MANUFACTURED IN HYOGO, JAPAN. CHLORTHALIDONE AS MANUFACTURED IN MAHARASHTRA, INDIA. SULFADOXINE AS MANUFACTURED IN SHANGHAI, CHINA. LORATADINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ZOLPIDEM TARTRATE (ESUB) AS MANUFACTURED IN PUNE, INDIA. NEPAFENAC AS MANUFACTURED IN BUBENDORF, SWITZERLAND. EXEMESTANE AS MANUFACTURED IN GRAFTON, WI. HUMANIZED MIK-BETA-1 MONOCLONAL ANTIBODY AS MANUFACTURED IN FREDERICK, MD. MODAFINIL AS MANUFACTURED IN BIASCA, SWITZERLAND. ASPIRIN STARCH GRANULES AS MANUFACTURED IN ANDHRA PRADESH, INDIA. EPHEDRINE HYDROCHLORIDE AS MANUFACTURED IN INNER MONGOLIA, CHINA. 10002-12 SLIP POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN AND ONTARIO, CANADA. LANSOPRAZOLE AS MANUFACTURED IN BARCELONA, SPAIN. VISCOMATE NP-700 (PARTIALLY NEUTRALIZED POLYACRYLATE) AS MANUFACTURED IN KANAGAWA, JAPAN. LOVASTAIN (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN CHONQING, CHINA FOR CHEMWERTH INC GATIFLOXACIN HEMIHYDRATE AS MANUFACTURED IN MORELOS, MEXICO. PHENOBARBITAL USP AS MANUFACTURED IN MAHARASHTRA, INDIA. CEFTRIAXONE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA. REPAGLINIDE USP AS MANUFACTURED IN GUJARAT, INDIA. FENTANYL CITRATE AS MANUFACTURED IN PETERSBURG, VA. CEFPROZIL AS MANUFACTURED IN MEXICO, MO. DAPOXETINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GEEL, BELGIUM. SIMVASTATIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. 894.143 PEPPERMINT FLAVOR, NATURAL AND ARTIFICIAL AS MANUFACTURED IN CAROL STREAM, IL. 862.547 LEMON MINT FLAVOR, NATURAL AND ARTIFICIAL AS MANUFACTURED IN CAROL STREAM, IL. FLUOROURACIL AS MANUFACTURED IN JIANGSU, P.R. CHINA. LOSARTAN POTASSIUM AS MANUFACTURED IN GIRONA, SPAIN. MAGNESIUM CHLORIDE HEXAHYDRATE AS MANUFACTURED IN FRANKFURTER STRABE, GERMANY. MICROCRYSTALLINE CELLULOSE AS MANUFACTURED IN NORTH GUJARAT, INDIA. ROSIGLITAZONE MALEATE AS MANUFACTURED IN MUMBAI, INDIA. 2-13C URACIL AS MANUFACTURED IN ANDOVER, MA. HEPARIN SODIUM AS MANUFACTURED IN BARCELONA, SPAIN.

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4Q2012EXCEL DMF# 17839 I 17840 17841 17842 17843 A 17844 I 17845 A 17846 17847 17848 17849 17850 17851 17852 A 17853 I 17854 A 17855 17856 17857 17858 17859 17860 17861 17862 17863 17864 17865 17866 17867 17868 I 17869 17870 A 17871 17872 A A II II 12/6/2004 12/3/2004 SIFAVITOR SRL GRANULES INDIA LTD A II III 12/1/2004 11/30/2004 I A A I N A A A A A A A I II III II II III II II II II 11/29/2004 3/10/2004 12/2/2004 12/1/2004 12/2/2004 12/6/2004 12/3/2004 12/1/2004 12/21/2004 II II III II 10/28/2004 10/26/2004 11/18/2004 11/29/2004 AXITEC CO LTD ASIAN HERBEX LTD HENKEL CORP DAICEL CHEMICAL INDUSTRIES LTD NOT AN ASSIGNED NUMBER CU CHEMIE UETIKON GMBH BASF CORP HARMAN FINOCHEM PVT LTD SCINOPHARM TAIWAN LTD PLASTIAPE SPA RANBAXY LABORATORIES LTD GEDEON RICHTER PLC LEK PHARMACEUTICALS DD TIANJIN CENTRAL PHARMACEUTICAL CO LTD SEKISUI MEDICAL CO LTD LOPAREX LLC 4-AMINOPYRIDINE AS MANUFACTURED IN LAHR, GERMANY. EPOTAL(R) P 350 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY. PHENYTOIN SODIUM USP AS MANUFACTURED IN MAHARASHTRA, INDIA. GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN TAIWAN, R.O.C. III 11/24/2004 WACKER CHEMICAL CORP II 11/15/2004 BOC MICRO APPLICATIONS CENTRE C A A I I A II II II II II II II 11/20/2004 11/22/2004 11/17/2004 11/22/2004 11/22/2004 11/16/2004 12/1/2004 II 11/17/2004 SHENZHEN HEPALINK PHARMACEUTICAL CO LTD DIVIS LABORATORIES LTD DR REDDYS LABORATORIES LTD QUIMICA SINTETICA SA USV LIMITED NOVADEL PHARMA INC AUROBINDO DATONG BIO PHARMA CO LTD OCEAN SPRAY CRANBERRIES INC II 11/15/2004 JUZEN CHEMICAL CORP A N A II III 11/22/2004 11/8/2004 II 11/19/2004 STATUS Type SUBMIT DATE III 11/15/2004 HOLDER BORMIOLI ROCCO E FIGLIO SPA PLASTIC DIV FARMHISPANIA SA NOT AN ASSIGNED NUMBER CIPLA LTD RAUMEDIC AG DISODIUM PAMIDRONATE (ESUB) AS MANUFACTURED IN PUNE, INDIA. SUBJECT PET BOTTLE 300 ML AS MANUFACTURED IN ITALY AND FRANCE.

4Q2012

FH-109 (MOEXIPRIL HYDROCHLORIDE) AS MANUFACTURED IN BARCELONA, SPAIN.

RAUMEDIC PVC-FREE COEXTRUDED FILLING TUBES AS MANUFACTURED IN HELBRECHTS AND REHAU, GERMANY. 5-AMINOLEVULINIC ACID HYDROCHLORIDE (JALA) AS MANUFACTURED IN TOYAMA PREFECTURE, JAPAN. HEPARIN SODIUM USP AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA. CARBIDOPA USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. NATEGLINIDE (PREMIX) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. PANTOPRAZOLE SODIUM AS MANUFACTURED IN MADRID, SPAIN. NIMODIPINE USP AS MANUFACTURED IN MUMBAI, INDIA. PROPOFOL LINGUAL SPRAY AS MANUFACTURED IN FLEMINGTON, NJ. NEVIRAPINE AS MANUFACTURED IN ANHRA PRADESH, INDIA. LOW CALORIE CRANBERRY JUICE COCKTAIL AND PLACEBO AS MANUFACTURED IN MIDDELBORO, MA. MICRO-CYLINDER PRESSURIZED GAS CAPSULES (LINE 1) AS MANUFACTURED IN SURREY, UNITED KINGDOM. VINNOL(R) LL 4320 AS MANUFACTURED IN VINNOLIT GMBH & CO KG IN BURGHAUSEN, GERMANY FOR WACKER POLYMER SYSTEMS LP. ALLOPURINOL USP AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA. CAPSAICIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. MACROMELT(R) 6900B AS MANUFACTURED IN KANKAKEE, IL. FK 307 DRUG SUBSTANCE AS MANUFACTURED IN NIIGATA, JAPAN.

RS01 DRY POWDER INHALER - MODEL 7 AS MANUFACTURED IN LECCO, ITALY. TAMSULOSIN HYDROCHLORIDE AS MANUFACUTERED IN PUNJAB, INDIA DROSPIRENONE AS MANUFACTURED IN BUDAPEST, HUNGARY. LOSARTAN POTASSIUM AS MANUFACTURED IN MENGES, SLOVENIA. ATENOLOL USP AS MANUFACTURED IN TIANJIN, CHINA. TAURINE AS MANUFACTURED IN IWATE PREFECTURE, JAPAN. GRADE 30158 S 2.5 BL SCK 6000/000 AS MANUFACTURED IN IOWA CITY, IA; EDEN, NC; DIXON, IL; AND CULLMAN, AL. MICONAZOLE AS MANUFACTURED IN LODIGIANO, ITALY. METHOCARBAMOL AS MANUFACTURED IN HYDERABAD, INDIA.

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4Q2012EXCEL DMF# 17873 17874 17875 17876 A 17877 A 17878 C 17879 17880 17881 17882 17883 17884 17885 17886 17887 17888 A 17889 17890 I 17891 17892 I 17893 17894 A 17895 17896 17897 17898 A 17899 I 17900 17901 17902 A 17903 A 17904 17905 A A III II 12/17/2004 12/17/2004 REXAM HEALTHCARE PACKAGING INC CIPLA LTD III 12/13/2004 A I II III II 12/3/2004 2/16/2005 10/14/2004 AUROBINDO PHARMA LTD REXAM PHARMA SAS MALLADI DRUGS AND PHARMACEUTICALS LTD SCANDOLARA SPA II 12/10/2004 FUJIMOTO PHARMACEUTICAL CORP A A A III III II III 12/13/2004 12/13/2004 12/15/2004 12/10/2004 SPL DESSECANTES LTDA SPL DESSECANTES LTDA RANBAXY LABORATORIES LTD NYPRO INC A III III 12/3/2004 12/13/2004 FPC FLEXIBLE PACKAGING CORP SPL DESSECANTES LTDA I II IV 12/13/2004 11/22/2004 ALBANY MOLECULAR RESEARCH INC ROHM AND HAAS CO SPI-860-1 DRUG SUBSTANCE AS MANUFACTURED IN ALBANY, NY. A II IV 12/14/2004 5/12/2005 I A I I A I I A A II II IV IV II II II III II II 12/7/2004 12/8/2004 12/2/2004 12/2/2004 12/7/2004 12/4/2004 10/5/2004 12/2/2004 12/21/2004 12/9/2004 II 12/3/2004 III 12/6/2004 STATUS Type SUBMIT DATE A C A II II III III 12/7/2004 12/3/2004 9/27/2004 12/2/2004 HOLDER SUN PHARMACEUTICAL INDUSTRIES LTD DIVIS LABORATORIES LTD BORMIOLI ROCCO SPA BU PLASTICS APTAR FRANCE SAS SUBJECT ISRADIPINE UPS AS MANUFACTURED IN MAHARASHTRA, INDIA. LEVODOPA USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. HDPE BOTTLE 50 ML AS MANUFACTURED IN ITALY AND FRANCE.

4Q2012

METHODS FOR CONTROLLING APTAR NITRILE ELASTOMERS AS MANUFACTURED IN VAL DE REUIL, FRANCE. EI DUPONT DE NEMOURS AND CO INC TYVEK(R) NONWOVEN SHEET AS MANUFACTURED IN RICHMOND, VA AND CONTERN, LUXEMBOURG. ZHEJIANG HISUN PHARMACEUTICAL CO LTD BICALUTAMIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF CHINA. CADILA HEALTHCARE LTD FLUVASTATIN SODIUM AS MANUFACTURED IN GUJARAT, INDIA. URQUIMA SA FONA INTERNATIONAL INC FONA INTERNATIONAL INC BIOVECTRA INC HAMNMI FINE CHEMICAL CO LTD CIBA SPECIALTY CHEMICALS LAJOVIC TUBA EMBALAZA DD LONZA INC ORCHID CHEMICALS AND PHARMACEUTICALS LTD SUN PHARMACEUTICAL INDUSTRIES LTD RIBA FAIRFIELD INC ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN BARCELONA, SPAIN. 926.418 N-C ARTIFICIAL VANILLA FLAVOR AS MANUFACTURED IN CAROL STREAM, IL. 856.435 GRAPE FLAVOR, ARTIFICIAL AS MANUFACTURED IN CAROL STREAM, IL. H.P. ACTHAR BULK AS MANUFACTURED IN CHARLOTTETOWN, CANADA. CEFTRIAXONE SODIUM, USP AS MANUFACTURED IN KYONGGI-DO, KOREA. TINUVIN 326 AS MANUFACTURED IN TARRYTOWN, NY. PLASTIC BLOW MOLDED CONTAINERS AS MANUFACTURED IN LJUBLJANA, SLOVENIA. TRIPROLIDINE HYDROCHLORIDE AS MANUFACTURED IN CONSHOHOCKEN, PA. CEFOTAXIME SODIUM, USP (STERILE BULK) AS MANUFACTURED IN NUNGAMBAKKAM, INDIA. CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA. ETHYL LACTATE, PHARMACEUTICAL GRADE (ESUB) AS MANUFACTURED IN DECATUR, IL.

DOW CORNING(R) ACRYLIC ADHESIVE EMULSIONS AS MANUFACTURED IN PIEDMONT, SC FOR ROHM AND HAAS CO POLYESTER/FOIL/POLYETHYLENE POUCH AS MANUFACTURED IN ONTARIO, CANADA. DESSECAP CAP - PLASTIC TOP CANISTER AS MANUFACTURED IN SAO PAULO, BRAZIL. DESSECAP CAC - PAPER TOP CANISTER AS MANUFACTURED IN SAO PAULO, BRAZIL. DESSECAP CPE - SIEVE EDGE CANISTER AS MANUFACTURED IN SAO PAULO, BRAZIL. VALSARTAN AS MANUFACTURED IN PUNJAB, INDIA. METERED-DOSE INHALER COUNTER ACTUATOR/STRAPCAP AS MANUFACTURED IN ARDEN, NC. (2Z)-[(ACETYLOXY)IMINO](2-AMINO-1,3-THIAZOL-4-YL)ACETIC ACID OR 3990 ACID AS MANUFACTURED IN OSAKA, JAPAN. LAMIVUDINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. DAIVOBET RANGE AS MANUFACTURED IN OFFRANSVILLE, FRANCE. TRIPROLIDINE HYDROCHLORIDE AS MANUFACTURED IN TAMIL NADU, INDIA. COLLAPSIBLE ALUMINUM TUBES FOR PHARMACEUTICAL USE AS MANUFACTURED IN ASCOLI PICENO, ITALY. MULTILAYER MLX PLASTIC COMPONENTS AS MANUFACTURED IN TOLEDO, OH. NEVIRAPINE (ESUB) AS MANUFACTURED IN PUNE, INDIA.

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4Q2012EXCEL DMF# 17906 17907 17908 17909 17910 17911 17912 17913 17914 17915 17916 17917 I 17918 I 17919 I 17920 I 17921 17922 17923 17924 17925 I 17926 17927 17928 17929 17930 17931 17932 A 17933 17934 17935 17936 I 17937 I 17938 I II 12/10/2004 STRAINRITE II 12/10/2004 STRAINRITE A A A II II II II 12/27/2004 12/27/2004 12/20/2004 12/10/2004 I A A A A A III III III III III III II 12/21/2004 12/21/2004 12/2/2004 12/21/2004 12/21/2004 12/21/2004 12/17/2004 I A A A II II II III II 12/20/2004 12/23/2004 12/15/2004 12/22/2004 12/23/2004 SOCIETA ITALIANA MEDICINALI SCANDICCI DR REDDYS LABORATORIES LTD LIFE TECHNOLOGIES CORP AIRSEC SA II 9/27/2004 STRAINRITE II 12/6/2004 STRAINRITE II 12/6/2004 STRAINRITE STATUS Type SUBMIT DATE A I C A C A A A A A A II IV II II II II II II II II II II 12/13/2004 12/9/2004 12/16/2004 12/16/2004 12/16/2004 12/8/2004 12/20/2004 12/15/2004 12/14/2004 12/16/2004 12/22/2004 12/6/2004 HOLDER CIPLA LTD FREUND CORP TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD AUROBINDO PHARMA LTD MYLAN LABORATORIES LTD RHODIA ORGANIQUE QUIMICA SINTETICA SA MYLAN LABORATORIES LTD CODY LABORATORIES INC STRAINRITE SUBJECT NATEGLINIDE (ESUB) AS MANUFACTURED IN PUNE, INDIA. NONPAREIL-108 AS MANUFACTURED IN HAMAMATSU CITY, JAPAN. FAMCICLOVIR AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. VALSARTAN AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. NATEGLINIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL.

4Q2012

CEFTRIAXONE SODIUM (STERILE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. IRBESARTAN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ACETAMINOPHEN USP AS MANUFACTURED IN ROUSSILLON, FRANCE. TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN MADRID, SPAIN. NEVIRAPINE USP (ANHYDROUS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. FENTANYL BASE USP AS MANUFACTURED IN CODY, WY. MD-3M-420, 282556: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN AUBURN, MAINE. MD-3M-45, 282513: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN AUBURN, MAINE. MD-3M-630, 282559: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN AUBURN, MAINE. DCC-MD-XX-45, 352001: CLARIFICATION CAPSULE FOR ONE TIME USE AS MANUFACTURED IN AUBURN, MAINE. ITRACONAZOLE AS MANUFACTURED IN FIRENZE, ITALY. ZIPRASIDONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CELL CULTURE MEDIA AS MANUFACTURED IN GRAND ISLAND, NY. DESICCANT JOINT AS MANUFACTURED IN ROMORANTIN, FRANCE.

UNION QUIMICO FARMACEUTICA SA UQUIFA BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN MILAN, ITALY. SA BOREALIS AS BORMED(TM) LE6603-PH AS MANUFACTURED IN STATHELLE, NORWAY. BOREALIS AG BOREALIS AG BOREALIS AG BOREALIS AG BOREALIS AG BORMED(TM) LE6609-PH AS MANUFACTURED IN STATHELLE, NORWAY. BORMED(TM) HF855MO AS MANUFACTURED IN STATHELLE, NORWAY. BORMED(TM) HD850MO AS MANUFACTURED IN STATHELLE, NORWAY. BORMED(TM) BE860MO AS MANUFACTURED IN STATHELLE, NORWAY. BORMED(TM) RB845MO AS MANUFACTURED IN STATHELLE, NORWAY.

ZHEJIANG HUAKANG PHARMACEUTICAL CO XYLITOL AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. LTD TARO PHARMACEUTICAL INDUSTRIES LTD CIPROFLOXACIN HYDROCHLORIDE, USP AS MANUFACTURED IN HAIFA BAY, ISRAEL. LUPIN LTD PCAS STRAINRITE SIMVASTATIN USP AS MANUFACTURED IN MAHARASHTRA, INDIA. ARTICAINE HCL AS MANUFACTURED IN TURKU, FINLAND FOR PCAS MD-3F-420, 282557: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN AUBURN, MAINE. MD-3F-630, 282560: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN AUBURN, MAINE. MD-3C-420, 282555: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN AUBURN, MAINE.

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4Q2012EXCEL DMF# 17939 I 17940 I 17941 I 17942 I 17943 A 17944 17945 17946 17947 17948 17949 A 17950 17951 17952 17953 17954 17955 17956 17957 17958 A 17959 17960 17961 A 17962 17963 A 17964 17965 17966 17967 17968 17969 I 17970 17971 A A II II 1/5/2005 12/12/2004 WANBURY LTD HUBEI HAOSUN PHARMACEUTICAL CO LTD A I A A A II II II II II IV 12/23/2004 1/3/2005 12/30/2004 1/3/2005 12/30/2004 1/5/2005 MITSUI NORIN CO LTD YUNNAN ZIYUN BIO TECH CO LTD FRESENIUS KABI ONCOLOGY LTD WUHAN SHIJI PHARMACEUTICAL CO LTD AUROBINDO PHARMA LTD NOVA NUTRACEUTICAL TECHNOLOGY LTD A II III 1/5/2005 1/5/2005 TRIFARMA SPA BILCARE LTD I A II II III 12/30/2004 12/29/2004 12/30/2004 GLENMARK PHARMACEUTICALS LTD HETERO LABS LTD LOPAREX BV I I I A A A A A IV II II II II III II II II 12/28/2004 12/29/2004 12/20/2004 12/27/2004 12/12/2004 12/30/2004 12/31/2004 12/31/2004 12/29/2004 FONA INTERNATIONAL INC QUIMICA SINTETICA SA MATRIX LABORATORIES (XIAMEN) LIMITED ARCH PHARMALABS LTD ARCH PHARMALABS LTD TEIJIN CHEMICALS LTD LUPIN LTD LUPIN LTD LUPIN LTD I A A A A II II II II III III 12/3/2004 12/29/2004 12/29/2004 12/29/2004 1/17/2005 12/16/2004 HONEYWELL IROPHARM PLC GLENMARK GENERICS LTD GLENMARK GENERICS LTD CADILA HEALTHCARE LTD POLYTAINERS INC CL SMITH CO BUTOCONAZOLE AS MANUFACTURED IN CO. WICKLOW, IRELAND. ZONISAMIDE AS MANUFACTURED IN GUJARAT STATE, INDIA. ITRACONAZOLE AS MANUFACTURED IN GUJARAT STATE, INDIA. CARVEDILOL AS MANUFACTURED IN GUJARAT, INDIA. PLASTIC BLOW MOLDED BOTTLES AS MANUFACTURED IN SIMI VALLEY, CA. II 12/29/2004 MYLAN LABORATORIES LTD III 11/30/2004 JAYCARE LTD II 12/10/2004 STRAINRITE II 12/10/2004 STRAINRITE STATUS Type SUBMIT DATE II 12/10/2004 HOLDER STRAINRITE SUBJECT

4Q2012

MD-3C-45, 282553: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN AUBURN, MAINE. MD-3F-45, 282554: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN AUBURN, MAINE. MD-3C-630, 282558: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN AUBURN, MAINE. JAYCAP CLOSURE RANGE AS MANUFACTURED IN NEWCASTLE UPON TYNE, UNITED KINGDOM. VALACYCLOVIR HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

ROUND, WHITE HIGH-DENSITY POLYETHYLENE (HDPE) BOTTLE WITH GRADUATIONS AND VIEW STRIPE AS MANUFACTURED IN ST. LOUIS, MO. 825.0029U CHERRY FLAVOR, ARTIFICIAL AS MANUFACTURED IN CAROL STREAM, IL. AZITHROMYCIN HYDROGENCITRATE AS MANUFACTURED IN MADRID, SPAIN. ZIDOVUDINE, USP AS MANUFACTURED IN FUJIAN, PEOPLE'S REPUBLIC OF CHINA. FCMIC CHLORIDE AS MANUFACTURED IN HYDERABAD, INDIA. DICMIC CHLORIDE AS MANUFACTURED IN HYDERABAD, INDIA. POLYETHYLENENAPHTHALATE RESIN AS MANUFACTURED IN EHIME-PREF., JAPAN. RAMIPRIL USP (PROCESS B) AS MANUFACTURED IN MADHYA PRADESH, INDIA. QUINAPRIL HYDROCHLORIDE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA. PERINDOPRIL TERT-BUTYLAMINE (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA. SIMVASTATIN AS MANUFACTURED IN GUJARAT STATE, INDIA. ESCITALOPRAM OXALATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. FL2000(TM) 75 UM PET C1S WITH GRADE CODE RT149 AS MANUFACTURED IN AZ APELDOORN, THE NETHERLANDS. OXANDROLONE USP AS MANUFACTURED IN MILANO, ITALY. BILCARE SPECIALTY ALUMINUM LID, STRIP AND COLD FORMING FOILS AS MANUFACTURED IN MAHARASHTRA, INDIA. POLYPHENON(R) E AS MANUFACTURED IN SHIZUOKA, JAPAN. PACLITAXEL, USP (BULK) AS MANUFACTURED IN YUNNAN, P.R. CHINA. PACLITAXEL SEMISYNTHETIC (ESUB) AS MANUFACTURED IN WEST BENGAL, INDIA. GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN HUBEI, CHINA. STAVUDINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. MICROCRYSTALLINE CELLULOSE/CARBOXY METHYL CELLULOSE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, STATE, INDIA. FLUMAZENIL AS MANUFACTURED IN HUBEI, P.R. CHINA.

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4Q2012EXCEL DMF# 17972 17973 I 17974 17975 17976 17977 A 17978 17979 A 17980 17981 A 17982 17983 I 17984 A 17985 I 17986 17987 17988 17989 17990 17991 17992 17993 17994 A 17995 A 17996 17997 17998 I 17999 A 18000 18001 A A II II 1/18/2005 1/18/2005 AVANTI POLAR LIPIDS INC AVANTI POLAR LIPIDS INC III 1/10/2005 CODING PRODUCTS A A III II III 1/20/2005 1/17/2005 1/10/2005 AMARTARA PRIVATE LTD HETERO LABS LTD CODING PRODUCTS IV 12/30/2004 HESEGO INDUSTRY A A A N N N N N IV 1/3/2005 II II II 12/1/2004 1/12/2005 1/12/2005 OLON SPA HETERO LABS LTD SIGNA SA DE CV NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER HANNS G WERNER GMBH CO KG III 1/3/2005 HUMPHREY COSBURN PLASTICS III 1/3/2005 HUMPHREY COSBURN PLASTICS A II III 1/12/2005 1/3/2005 OLON SPA HUMPHREY COSBURN PLASTICS A II V 1/11/2005 12/21/2004 SUN PHARMACEUTICAL INDUSTRIES LTD MYCENAX BIOTECH INC A II II 1/6/2005 1/12/2005 SUN PHARMACEUTICAL INDUSTRIES LTD HETERO DRUGS LTD A A A II II II II 12/14/2004 1/6/2005 1/6/2004 1/6/2005 STATUS Type SUBMIT DATE A II II 1/5/2005 1/6/2004 HOLDER ZHEJIANG YIXIN PHARMACEUTICAL CO LTD SUBJECT GALANTAMINE HBR. AS MANUFACTURED IN ZHEJIANG, P.R. CHINA.

4Q2012

UNION QUIMICO FARMACEUTICA SA UQUIFA CILOSTAZOL AS MANUFACTURED IN MILAN, ITALY. SA FIDIA FARMACEUTICI SPA RIFAXIMIN AS MANUFACTURED IN MULAZZANO (LO), ITALY. MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD ZONISAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. STAVUDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. TIAGABINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA. CITALOPRAM HYDROBROMIDE (PROCESS I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ONDANSETRON AS MANUFACTURED IN GUJARAT, INDIA. PROCESS DEVELOPMENT AND PRODUCTION FOR BIOLOGICAL THERAPEUTICS IN MIAOLI, TAIWAN. PERGOLIDE MESYLATE AS MANUFACTURED IN RODANO (MI), ITALY. 48/400 BLACK ROUND STACKING TOP F/RIBBED PP CAP AS MANUFACTURED IN ONTARIO, CANADA. 53/400 WHITE ROUND SMOOTH TOP F/RIBBED PP CAP AS MANUFACTURED IN ONTARIO, CANADA. 43/400 WHITE ROUND SMOOTH TOP F/RIBBED PP CAP AS MANUFACTURED IN ONTARIO, CANADA. CEFDINIR HYDRATE AS MANUFACTURED IN RODANO (MI), ITALY AND LEON, SPAIN. TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. OXCARBAZEPINE AS MANUFACTURED IN TOLUCA, MEXICO.

PHARM-A-SPHERES(TM) SUGAR SPHERES NF AS MANUFACTURED IN TORNESCH, GERMANY. TRISTAR NF AND TRISTAR 149 AS MANUFACTURED IN SELANGOR, MALAYSIA FOR HESEGO INDUSTRY PVC/PVDC PACKAGING MATERIAL AS MANUFACTURED IN MAHARASHTRA, INDIA. STAVUDINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CDF-4, A HOT STAMP INK RIBBON USED IN THE LABELING OF A VARIETY OF DRUG PRODUCTS SUCH AS IV BAGS AND SINGLE DOSE VIALS AS MANUFACTURED IN KALKASKA, MI. DOI-4, A HOT STAMP INK RIBBON USED IN THE LABELING OF A VARIETY OF DRUG PRODUCTS SUCH AS IV BAGS AND SINGLE DOSE VIALS AS MANUFACTURED IN KALKASKA, MI. FENRETINIDE LYM-X-SORB(TM) POWDER AS MANUFACTURED IN ALABASTER, AL. FENRETINIDE LYM-X-SORB(TM) OIL AS MANUFACTURED IN ALABASTER, AL.

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4Q2012EXCEL DMF# 18002 A 18003 I 18004 I 18005 18006 A 18007 18008 18009 A 18010 I 18011 A 18012 18013 18014 C 18015 18016 18017 A 18018 A 18019 18020 A 18021 18022 18023 18024 18025 18026 A 18027 A 18028 A 18029 18030 A 18031 A II 1/26/2005 I II II 1/24/2005 1/24/2005 NINGBO SMART PHARMACEUTICAL CO LTD III 1/3/2005 HUMPHREY COSBURN PLASTICS III 1/25/2005 BOREALIS AG A A N A A II IV III 3/22/2005 1/27/2005 1/25/2005 II II 1/26/2005 1/26/2005 CIPLA LTD CIPLA LTD NOT AN ASSIGNED NUMBER LUPIN LTD BASF CORP BOREALIS AG RAMIPRIL USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA. POLOXAMERS AS MANUFACTURED IN WASHINGTON, NJ. A II III 1/18/2005 1/13/2005 JOHNSON MATTHEY PHARMA SERVICES RENOLIT NEDERLAND BV II 1/21/2005 SANOFI AVENTIS DEUTSCHLAND GMBH A A II II II 1/12/2005 1/19/2005 1/17/2005 BIOFER SPA SUN PHARMACEUTICAL INDUSTRIES LTD SAFC BIOSCIENCES INC IRON SUCROSE INJECTION AS MANUFACTURED IN MEDOLLA (MO), ITALY. SODIUM VALPORATE EP AS MANUFACTURED IN MAHARASHTRA, INDIA. A A III II II 1/3/2005 1/20/2005 1/20/2005 US INGREDIENTS INC DBA ABELEI DR REDDYS LABORATORIES LTD IV 1/14/2005 FONA INTERNATIONAL INC III 1/3/2005 HUMPHREY COSBURN PLASTICS A I II III III 1/12/2005 8/30/2004 1/3/2005 KATWIJK CHEMIE BV INDUSTRIAL GOMERA SA DE CV HUMPHREY COSBURN PLASTICS A II III 1/10/2005 1/14/2005 II 1/13/2005 KUNSHAN CHEMICAL AND PHARMACEUTICAL CO LTD SYN TECH CHEM AND PHARM CO LTD WEST PHARMACEUTICAL SERVICES INC II 1/12/2005 CHEMWERTH INC STATUS Type SUBMIT DATE II 1/18/2005 HOLDER AVANTI POLAR LIPIDS INC SUBJECT

4Q2012

LYM-X-SORB(TM) LIPID MATRIX FOR DRUG DELIVERY AS MANUFACTURED IN ALABASTER, AL. REPAGLINIDE USP AS MANUFACTURED BY LIANYUNGANG HANSEN PHARMACEUTICAL CO LTD IN LIANYUNGANG, CHINA FOR CHEMWERTH INC. DOXYCYCLINE HYCLATE USP AS MANUFACTURED IN IN KUNSHAN CITY, JIANGSU, CHINA LIDOCAINE AS MANUFACTURED IN HSING-YING, TAIWAN, R.O.C. CLIP 'N' JECT(TM) RECONSTITUTION SYSTEM AS MANUFACTURED IN MONTGOMERY, PA. SODIUM VALPROATE POWDER AS MANUFACTURED IN KATWIJK, THE NETHERLANDS. RIB-TIP-CAP CHLOROBUTYL RUBBER AS MANUFACTURED IN EDO. DE MEXICO, MEXICO. 38/400 WHITE ROUND SMOOTH TOP F/RIBBED PP CAP AS MANUFACTURED IN ONTARIO, CANADA. 70/400 WHITE ROUND STACKING TOP F/RIBBED PP CAP AS MANUFACTURED IN ONTARIO, CANADA. 831.028 PINA COLADA FLAVOR (A NATURAL AND ARTIFICIAL FLAVOR) AS MANUFACTURED IN ONTARIO, CANADA. CHERRY FLAVOR FORMULATIONS GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

PHARMACEUTICAL WORKS POLPHARMA SA BACLOFEN AS MANUFACTURED IN STAROGARD GDANSKI, POLAND.

EX-CELL(TM) 325 PF CHO, SERUM-FREE MEDIUM, PROTEIN FREE AS MANUFACTURED IN DENVER, PA. GLYBURIDE USP (GLIBENCLAMIDE), MILLED AS MANUFACTURED IN GUJARAT, INDIA FOR AVENTIS PHARMA DEUTSCHLAND GMBH EPOPROSTENOL SODIUM AS MANUFACTURED IN CORK, IRELAND. SOLMED(R) ALKA FORMULATIONS AS MANUFACTURED IN AA ENKHUIZEN, THE NETHERLANDS. RIZATRIPTAN BENZOATE (ESUB) AS MANUFACTURED IN PUNE, INDIA. ZALEPLON (ESUB) AS MANUFACTURED IN PUNE, INDIA.

BOREALIS POLYETHYLENE FG5224 AS MANUFACTURED BY BOREALIS AB IN STENUNGSUND, SWEDEN FOR BOREALIS AS. BOREALIS POLYETHYLENE FG5223 AS MANUFACTURED BY BOREALIS AB IN STENUNGSUND, SWEDEN FOR BOREALIS AS. 33/400 WHITE ROUND SMOOTH TOP F/RIBBED PP CAP AS MANUFACTURED IN ONTARIO, CANADA. GUAIFENESIN USP AS MANUFACTURED IN NINGBO, CHINA.

ZHEJIANG HISUN PHARMACEUTICAL CO LTD TOLTERODINE TARTRATE, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF CHINA. TARO PHARMACEUTICAL INDUSTRIES LTD IMIQUIMOD AS MANUFACTURED IN HAIFA BAY, ISRAEL. Page 535

4Q2012EXCEL DMF# 18032 18033 A 18034 18035 18036 18037 18038 18039 18040 18041 18042 18043 18044 A 18045 18046 I 18047 A 18048 18049 18050 18051 A 18052 18053 A 18054 18055 18056 18057 18058 I 18059 18060 18061 A 18062 18063 A 18064 18065 I A II II 2/4/2005 2/6/2005 A II II 2/3/2005 2/8/2005 FLAMMA SPA ZHEJIANG XIANJU PHARMACEUTICAL CO LTD CHENG FONG CHEMICAL CO LTD DIVIS LABORATORIES LTD A A II II III 2/7/2005 2/7/2005 1/26/2005 A A A A II II II II II 2/2/2005 2/4/2005 2/3/2005 1/24/2005 2/1/2005 SOCIETA ITALIANA MEDICINALI SCANDICCI LUPIN LTD ISOCHEM SAS CHENG FONG CHEMICAL CO LTD SUZHOU WANQING PHARMACEUTICALS CO LTD WOCKHARDT LTD WOCKHARDT LTD AMPACET CORP A II II 2/1/2005 2/2/2005 MEDICHEM SA POLYCARBON INDUSTRIES INC N A A II II II 2/3/2005 2/3/2005 2/2/2005 V 1/18/2005 I II III 1/28/2005 2/1/2005 SA AJINOMOTO OMNICHEM NV AVERY DENNISON GALANTAMINE HBR AS MANUFACTURED IN LOUVAIN-LA-NEUVE, BELGIUM A A A A A A A A I A III III III III III III III III II II II 1/17/2005 1/17/2005 1/17/2005 1/17/2005 1/17/2005 1/17/2005 2/1/2005 2/1/2005 1/31/2005 2/1/2005 2/1/2005 3M DRUG DELIVERY SYSTEMS 3M DRUG DELIVERY SYSTEMS 3M DRUG DELIVERY SYSTEMS 3M DRUG DELIVERY SYSTEMS 3M DRUG DELIVERY SYSTEMS 3M DRUG DELIVERY SYSTEMS BOREALIS AG BOREALIS AG RANBAXY LABORATORIES LTD FARMABIOS S P A SANDOZ INDUSTRIAL PRODUCTS SA STATUS Type SUBMIT DATE I II IV 1/25/2005 1/29/2005 HOLDER ALKALOIDS CORP DAIDO CHEMICAL CORP SUBJECT COLCHICINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

4Q2012

POVACOAT(TM) (POLYVINYLALCOHOL-ACRYLIC ACID-METHYL METHACRYLATE COPOLYMER) AS MANUFACTURED IN OSAKA, JAPAN. SCOTCHPAK (TM) 1109 AS MANUFACTURED IN COTTAGE GROVE, MN SCOTCHPAK (TM) 1006 AS MANUFACTURED IN COTTAGE GROVE, MN SCOTCHPAK (TM) 1020 AS MANUFACTURED IN COTTAGE GROVE, MN SCOTCHPAK (TM) 1220 AS MANUFACTURED IN COTTAGE GROVE, MN SCOTCHPAK (TM) 1012 AS MANUFACTURED IN COTTAGE GROVE, MN SCOTCHPAK (TM) 1022 AS MANUFACTURED IN COTTAGE GROVE, MN BOREALIS HE9621-PH AS MANUFACTURED IN BURGHAUSEN, GERMANY BOREALIS BORMED(TM) HE2581-PH AS MANUFACTURED IN BURGHAUSEN, GERMANY. ZIPRASIDONE HYDROCHLORIDE AS MANUFACTURED IN PUNJAB, INDIA. CYPROTERONE ACETATE AS MANUFACTURED IN PAVIA, ITALY. AMOXICILLIN SODIUM (NON-STERILE BULK) AS MANUFACTURED IN BARCELONA, SPAIN.

ACCU-PLACE-IN-MOLD LABEL (APIML) PRODUCT AS MANUFACTURED IN STRONGSVILLE, OH. MONOGRAM BIOSCIENCES A LABCORP SUB PHENOSENSE(TM) HIV ENTRY TROPISM ASSAY VALIDATION PACKET AS MANUFACTURED IN SOUTH SAN FRANCISCO, CA. NOT AN ASSIGNED NUMBER CADILA HEALTHCARE LTD APOTEX PHARMACHEM INC SERTRALINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA. ZIPRASIDONE HYDROCHLORIDE AS MANUFACTURED IN ONTARIO, CANADA.

CHIFENG PHARMACEUTICAL GROUP CO LTD GRISEOFULVIN, USP AS MANUFACTURED IN INNER MONGOLIA, CHINA. PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN GIRONA, SPAIN. PCI-8024 (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN LEOMINSTER, MA. MESALAMINE AS MANUFACTURED IN FIRENZE, ITALY. ZIPRASIDONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. GEMFIBROZIL AS MANUFACTURED IN PITHIVIERS, FRANCE. PHENYLEPHRINE HYDROCHLORIDE AS MANUFACTURED IN TAIWAN, R.O.C. LORATADINE AS MANUFACTURED IN JIANGSU, CHINA. ZONISAMIDE AS MANUFACTURED IN MAHARASHTRA, INDIA. STERILE SODIUM CARBONATE AS MANUFACTURED IN MAHARASHTRA, INDIA. 111680 WHITE POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA; HEATH, OH; AND LATEXO, TX. MODAFINIL AS MANUFACTURED IN BERGAMO, ITALY. PREDNISOLONE ANHYDROUS, USP AS MANUFACTURED IN ZHEJIANG, CHINA. DIVALPROEX SODIUM AS MANUFACTURED IN TAOYUAN, TAIWAN. PROGUANIL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

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4Q2012EXCEL DMF# 18066 18067 I 18068 18069 A 18070 A 18071 18072 18073 18074 A 18075 18076 18077 A 18078 18079 18080 18081 18082 A 18083 A 18084 18085 I 18086 18087 18088 18089 I 18090 18091 18092 18093 18094 18095 18096 A A A A A A A II II III III III III IV 2/17/2005 2/18/2005 2/8/2005 2/10/2005 2/10/2005 2/10/2005 2/8/2005 CADILA HEALTHCARE LTD R TECH UENO LTD DUPONT ENGINEERING POLYMERS POLYONE CORP POLYONE CORP POLYONE CORP AUTHENTIX INC LAMOTRIGINE AS MANUFACTURED IN GUJARAT, INDIA. LUBIPROSTONE (RU-0211) AS MANUFACTURED IN HYOGO, JAPAN. CRASTIN(R) 6131C NC010 AS MANUFACTURED IN MONCK'S CORNER, SC. I N N III 2/3/2005 II 2/4/2005 MALLINCKRODT INC NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER AMPACET CORP A II III 2/15/2005 11/23/2004 CHEMAGIS LTD JAYCARE LTD PENTOXYFYLLINE AS MANUFACTURED IN WIESBADEN, GERMANY. II 12/12/2004 A A I A II II II II II 2/9/2005 2/9/2005 2/10/2005 2/3/2005 2/1/2005 MACFARLAN SMITH LTD LONZA AG FIS FABBRICA ITALIANA SINTETICI SPA CORDEN PHARMA LATINA SPA LEK PHARMACEUTICALS DD A A II II II 2/6/2005 2/11/2005 2/11/2005 TEVA PHARMACEUTICAL INDUSTRIES LTD CATALENT PHARMA SOLUTIONS LLC PEPTISYNTHA SA I I A II II II III 1/21/2005 1/31/2005 2/11/2005 1/4/2005 AXITEC CO LTD AXITEC CO LTD WOCKHARDT LTD STYROLUTION GMBH III 2/9/2005 A II II 2/9/2005 2/8/2005 CADILA HEALTHCARE LTD BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG CEODEUX SA STATUS Type SUBMIT DATE C II II 2/6/2005 1/22/2005 HOLDER DIVIS LABORATORIES LTD TAI HENG INDUSTRY CO LTD SUBJECT IOPAMIDOL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

4Q2012

TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN CHANZHOU SIYAO PHARMACEUTICAL CO LTD IN JIANGSU, CHINA FOR TAI HENG INDUSTRY TRADE & CO LTD. RISPERIDONE AS MANUFACTURED IN GUJARAT, INDIA. METHSCOPOLAMINE BROMIDE AS MANUFACTURED IN INGELHEIM AM RHEIN, GERMANY. HIGH PRESSURE VALVE SERIE D 413 FOR CYLINDERS CONTAINING GASEOUS MIXTURE DRUGS UNDER PRESSURE AS MANUFACTURED IN LINTGEN, LUXEMBORG. CYTARABINE, USP AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA. CLADRIBINE AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA. ANHYDROUS AZITHROMYCIN AS MANUFACTURED IN GUJARAT, INDIA. TERLUX(R) 2802 HD AS MANUFACTURED IN LUDWIGSHAFEN AND SCHWARZHEIDE, GERMANY. ALPRAZOLAM AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. LUBIPROSTONE, 24 MCG CAPSULES AS MANUFACTURED IN ST. PERTERSBURG, FL. CETRORELIX ACETATE BULK DRUG SUBSTANCE AS MANUFACTURED IN BRUSSELS, BELGIUM. GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN SCOTLAND, ENGLAND. EPROSARTAN MESYLATE (ROUTE F1) AS MANUFACTURED IN VISP, SWITZERLAND. CLOBAZAM AS MANUFACTURED IN VICENZA, ITALY. CEPHAPIRIN BENZATHINE AS MANUFACTURED IN LATINA, ITALY.

ATORVASTATIN CALCIUM, ACTIVE SUBSTANCE AS MANUFACTURED IN MENGES, SLOVENIA. ZHEJIANG HUAYI PHARMACEUTICAL CO LTD CIPROFLOXACIN AS MANUFACTURED IN ZHEJIANG, CHINA.

1LITRE PHARMA BOTTLE AS MANUFACTURED IN NEW CASTLE UPON TYNE, UNITED KINGDOM. BUTALBITAL USP, CODE 5678 (ESUB) AS MANUFACTURED IN ST. LOUIS, MO.

111155 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRYTOWN, NY; TERRE HAUTE, IN; CARTERSVILLE, GA; LATEXO, TX; HEATH, OH; AND DERIDDER, LA.

CC10004832WE ACC05612P ORANGE AS MANUFACTURED IN ELK GROVE VILLAGE, IL. CC00022000WE TVC01545P WHITE AS MANUFACTURED IN ELK GROVE VILLAGE, IL. CC10004654WE ACC40487P YELLOW AS MANUFACTURED IN ELK GROVE VILLAGE, IL. AUTHENTIX SECURITY INK FORMULATION FOR PACKAGING AS MANUFACTURED IN DOUGLASSVILLE, PA.

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4Q2012EXCEL DMF# 18097 I 18098 I 18099 18100 A 18101 18102 18103 18104 18105 I 18106 18107 18108 18109 18110 18111 18112 18113 18114 18115 18116 I 18117 18118 18119 18120 18121 18122 18123 I 18124 A 18125 18126 18127 I 18128 A 18129 A II 3/3/2005 II 2/21/2005 NANJING KING FRIEND BIOCHEMICAL PHARMACEUTICAL CO LTD SMS PHARMACEUTICALS LTD HEPARIN SODIUM USP AS MANUFACTURED IN JIANGSU, CHINA. A A II II II 2/28/2005 2/28/2005 3/3/2005 II 2/24/2005 A A A A I A II II II II III II II 2/17/2005 2/23/2005 2/25/2005 2/18/2005 2/25/2005 2/23/2005 2/17/2005 AUROBINDO PHARMA LTD CADILA HEALTHCARE LTD CADILA HEALTHCARE LTD AUROBINDO PHARMA LTD PORVAIR FILTRATION GROUP MOREPEN LABORATORIES LTD ZHEJIANG SUPOR PHARMACEUTICALS CO LTD SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTD STERLING SRL HIKMA PHARMACEUTICALS A A I A A A A C A I II II II II IV II II II II II II 2/22/2005 2/21/2005 2/7/2005 2/18/2005 2/16/2005 2/10/2005 2/23/2005 2/21/2005 2/22/2005 2/25/2005 2/25/2005 I A I I II II II II II 1/25/2005 2/16/2005 2/18/2005 2/16/2005 2/16/2005 ZHEJIANG RUIBANG LABORATORIES DAINIPPON SUMITOMO PHARMA CO LTD DR REDDYS LABORATORIES LTD IPCA LABORATORIES LTD CHANGZHOU JIAREKE PHARMACEUTICAL GROUP CORP LTD PCAS SIGMA ALDRICH IRELAND LTD VENKAT PHARMA LTD NOVASEP PROCESS SAS MEDI CAPS LTD R L FINE CHEM TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD RANBAXY LABORATORIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD JM HUBER CORP A II III 9/10/2004 2/12/2005 JOHNSON MATTHEY FINLAND LTD AUTOFITS PACKAGING PVT LTD UNIT II III 11/18/2004 STATUS Type SUBMIT DATE III 2/4/2005 HOLDER BERRY PLASTICS CORP TAPES AND COATINGS DIV JAYCARE LTD SUBJECT

4Q2012

72 GA PVDC COATED NYLON/10# LDPE/.00285 FOIL/10# LDPE/1.75 MIL LLDPE WITH EVA FILM AS MANUFACTURED IN COLUMBUS, GA. 150ML ANTIBIOTIC BOTTLE WITH 28MM CLIC-LOC NECK FINISH AS MANUFACTURED IN NEWCASTLE UPON TYNE, UNITED KINGDOM. SMOPEX-111 AS MANUFACTURED IN TURKU, FINLAND. CLOSURES CAPS FOR BOTTLES AND SEALS FOR INJECTION VIALS AS MANUFACTURED IN NASHIK, INDIA. SIMVASTATIN USP AS MANUFACTURED IN ZHEJIANG, CHINA. MEROPENEM BULK BLEND AS MANUFACTURED IN OITA, JAPAN. ZONISAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. LISINOPRIL AS MANUFACTURED IN RATLAM, INDIA. BENZOCAINE AS MANUFACTURED IN JIANGSUPROS, CHINA. GLYCOPYRROLATE AS MANUFACTURED IN TURKU, FINLAND FOR PCAS ARMODAFINIL DRUG SUBSTANCE AS MANUFACTURED IN CO. WICKLOW, IRELAND. OLANZAPINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ARMODAFINIL AS MANUFACTURED IN POMPEY, FRANCE. EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN M.P., INDIA. AMITRIPTYLINE HYDROCHLORIDE AS MANUFACTURED IN KARNATAKA, INDIA. GALANTHAMINE HYDROBROMIDE AS MANUFACTURED IN OPAVA, CZECH REPUBLIC. CABERGOLINE AS MANUFACTURED IN OPAVA, CZECH REPUBLIC. GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN PUNJAB, INDIA. OXAZEPAM AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. CALCIUM CARBONATE AS MANUFACTURED BY J.M. HUBER MICROPOWDERS INC IN BENICIA, CA FOR JM HUBER CORP. LISINOPRIL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. LEVOFLOXACIN HEMIHYDRATE AS MANUFACTURED IN GUJARAT, INDIA. ESCITALOPRAM OXALATE AS MANUFACTURED IN GUJARAT, INDIA. RISPERIDONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. PLASTIC FILTERS AS MANUFACTURED IN WREXHAM, UNITED KINGDOM. ATORVASTATIN CALCIUM AS MANUFACTURED IN HIMACHAL PRADESH, INDIA. BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN ZHEJIANG PROVINCE, R.P. CHINA. GEMFIBROZIL AS MANUFACTURED IN SHANGHAI, CHINA NORELGESTROMIN AS MANUFACTURED IN PERUGIA, ITALY. BETAMETHASONE ACETATE (STERILE) USP AS MANUFACTURED IN AMMAN, JORDAN.

PHARMACEUTICAL WORKS POLPHARMA SA BUPROPION HYDROCHLORIDE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND.

RANITIDINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

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4Q2012EXCEL DMF# 18130 A 18131 A 18132 I 18133 18134 18135 A 18136 18137 18138 18139 18140 18141 18142 18143 A 18144 18145 18146 18147 18148 18149 A 18150 18151 18152 18153 18154 18155 A 18156 A 18157 A 18158 18159 18160 18161 18162 18163 I A A A I A II II II II IV II 3/11/2005 3/8/2005 3/10/2005 3/11/2005 3/11/2005 3/14/2005 II 3/10/2005 NORTH CHINA PHARMACEUTICAL HUASHENG CO LTD URQUIMA SA UQUIFA MEXICO SA DE CV DERMAL RESEARCH LABORATORIES, INC. SANDOZ INDUSTRIAL PRODUCTS SA BORREGAARD INDUSTRIES LTD GLENMARK GENERICS LTD III 3/7/2005 A I A A A II II II II II II 3/2/2005 2/24/2005 3/3/2005 3/4/2005 2/28/2005 3/7/2005 A A I A A III II II II II II 2/28/2005 3/7/2005 3/2/2005 3/4/2005 2/21/2005 3/8/2005 SHREE RUBBERPLAST CO. PVT. LTD. TARO PHARMACEUTICAL INDUSTRIES LTD DAINIPPON SUMITOMO PHARMA CO LTD SIFAVITOR SRL BIDACHEM SPA ORCHID CHEMICALS AND PHARMACEUTICALS LTD WANBURY LTD COATING PLACE INC SA AJINOMOTO OMNICHEM NV CADILA HEALTHCARE LTD AUROBINDO PHARMA LTD DISHMAN PHARMACEUTICALS AND CHEMICALS LTD APTAR FRANCE SAS A I A I A A A III II II II IV II II IV 1/14/2005 3/3/2005 2/24/2005 3/7/2005 3/1/2005 3/3/2005 3/4/2005 3/8/2005 A A II III II 3/1/2005 3/1/2005 3/3/2005 II 3/2/2005 SHANGHAI SUNVE PHARMACEUTICAL CO. LTD. SEKISUI MEDICAL CO LTD MGJ BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG SCHOTT KAISHA PVT LTD CF PHARMA LTD HAUDONG MEDICINE CO LTD BOEHRINGER INGELHEIM CHEMICALS INC CRODA INC CF PHARMA LTD TEVA PHARMACEUTICAL INDUSTRIES LTD ROQUETTE FRERES GEMFIBROZIL AS MANUFACTURED IN SHANGHAI, CHINA. N-ACETYL-L-TYROSINE AS MANUFACTURED IN IWATE PREFECTURE, JAPAN. IV 2/25/2005 UNGERER AND CO STATUS Type SUBMIT DATE IV 2/25/2005 HOLDER UNGERER AND CO SUBJECT

4Q2012

NATURAL & ARTIFICIAL ORANGE FLAVOR FN-924 AS MANUFACTURED IN BETHLEHEM, PA. NATURAL & ARTIFICIAL GRAPE FLAVOR FM-4962 AS MANUFACTURED IN BETHLEHEM, PA.

CORELEN/AI/PTFE LINER AS MANUFACTURED IN CHAZAY D'AZERGUES, FRANCE. TIOTROPIUM BROMIDE MONOHYDRATE AS MANUFACTURED IN INGELHEIM AM RHEIN, GERMANY. GLASS CYLINDERS FOR CARTRIDGES AS MANUFACTURED IN DAMAN, INDIA. LAMOTRIGINE AS MANUFACTURED IN BUDAPEST, HUNGARY. ACARBOSE AS MANUFACTURED IN ZHEJIANG, CHINA. FENTANYL BASE AS MANUFACTURED IN PETERSBURG, VA. SUPER REFINED NOVOL NF (OLEYL ALCOHOL) AS MANUFACTURED IN MILL HALL, PA. BICALUTAMIDE AS MANUFACTURED IN BUDAPEST, HUNGARY. HYDROCORTISONE BUTYRATE AS MANUFACTURED IN LERMA, MEXICO. MANNITOL USP POWDER PEARLITOL (R) AS MANUFACTURED IN LESTREM CEDEX, FRANCE. DROPPER BOTTLES, NOZZLES AND CAPS AS MANUFACTURED IN GOKHIWARE, INDIA. CARVEDILOL AS MANUFACTURED IN HAIFA BAY, ISRAEL. SMP-797 DRUG SUBSTANCE AS MANUFACTURED IN OSAKA, JAPAN. NAFTIFINE HYDROCHLORIDE AS MANUFACTURED IN CASALETTO LODIGIANO, ITALY. KETOPROFEN AS MANUFACTURED IN FORNOVO S. GIOVANNI, ITALY. CEFOXITIN SODIUM USP (STERILE) AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA METFORMIN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA. COATED DEXTROMETHORPHAN POLISTIREX AS MANUFACTURED IN VERONA, WI. GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN WETTEREN, BELGIUM. LOSARTAN POTASSIUM AS MANUFACTURED IN GUJARAT, INDIA. CEFOTAXIME SODIUM (STERILE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. EPROSARTAN MESYLATE AS MANUFACTURED IN AHMEDABAD, INDIA. APTAR PACKAGING COMPONENTS FOR TOPICAL OR TRANSDERMAL APPLICATIONS AS MANUFACTURED IN FRANCE, SWITZERLAND, US AND IRELAND AMPHOTERICIN B USP NON-STERILE BULK DRUG AS MANUFACTURED IN HEBEI, CHINA. CARVEDILOL, MICRONIZED AS MANUFACTURED IN BARCELONA, SPAIN. LEVOFLOXACIN HEMIHYDRATE AS MANUFACTURED IN MORELOS, MEXICO. GEN443 (TM) SODIUM HYALURONATE AS MANUFACTURED IN SHAWNEE, KS. PIPERACILLIN AS MANUFACTURED IN BARCELONA, SPAIN. CELLOBIOSE OCTAACETATE XP AS MANUFACTURED IN SARPSBORG, NORWAY. BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA.

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4Q2012EXCEL DMF# 18164 18165 18166 18167 18168 18169 I 18170 I 18171 A 18172 18173 18174 18175 18176 18177 18178 18179 18180 18181 I 18182 I 18183 I 18184 I 18185 I 18186 A 18187 A 18188 18189 A 18190 I 18191 18192 18193 18194 A A A A II II II II 3/22/2005 3/11/2005 3/22/2005 3/23/2005 SUN PHARMACEUTICAL INDUSTRIES LTD AUROBINDO PHARMA LTD CYALUME SPECIALTY PRODUCTS INC CEDARBURG PHARMACEUTICALS LLC II 3/9/2005 I II IV 3/15/2005 3/14/2005 ZHEJIANG RUIBANG LABORATORIES STANDARD CHEMICAL AND PHARMACEUTICAL CO LTD PARTICLE DYNAMICS INC II 3/17/2005 CATALENT PHARMA SOLUTIONS LLC II 3/14/2005 ZENTIVA KS III 3/7/2005 AMPACET CORP III 3/7/2005 AMPACET CORP III 3/7/2005 AMPACET CORP III 3/7/2005 AMPACET CORP A A I A A A A I A II II II II II II II II II III 3/4/2005 3/2/2005 3/2/2005 3/14/2005 2/28/2005 3/15/2005 3/14/2005 3/11/2005 2/25/2005 3/7/2005 II 3/3/2005 III 3/7/2005 STATUS Type SUBMIT DATE A A A A A II II II II III II 3/14/2005 3/14/2005 3/8/2005 11/19/2004 3/16/2005 3/15/2005 HOLDER GLENMARK GENERICS LTD GLENMARK GENERICS LTD SAFC BIOSCIENCES INC SANDOZ INDUSTRIAL PRODUCTS GMBH JAMES ALEXANDER CORP TEVA GROUP ACTIVE PHARMACEUTICAL INGREDIENTS DIV CARCLO TECHNICAL PLASTICS (MITCHAM) LIMITED LABORATORIO CHIMICO INTERNAZIONALE SPA SUN PHARMACEUTICAL INDUSTRIES LTD WANBURY LTD WANBURY LTD GLENMARK GENERICS LTD AUROBINDO PHARMA LTD WOCKHARDT LTD CEDARBURG PHARMACEUTICALS LLC CIPLA LTD NATCO PHARMA LTD AMPACET CORP SUBJECT ZOLPIDEM TARTRATE AS MANUFACTURED IN GUJARAT, INDIA. TRANDOLAPRIL AS MANUFACTURED IN GUJARAT, INDIA. EX-CELL (TM) 293 MEDIUM AS MANUFACTURED IN DENVER, PA PACA, PURE AS MANUFACTURED IN FRANKFURT, GERMANY. PLASTIC AMPOULE AS MANUFACTURED IN BLAIRSTOWN, NJ LR-103 AS MANUFACTURED IN BE'ER SHEVA, ISRAEL MDI ACTUATOR AND CAP AS MANUFACTURED IN SURRAY, U.K. GABAPENTIN AS MANUFACTURED IN MILAN, ITALY. TOPIRAMATE AS MANUFACTURED IN GUJARAT, INDIA.

4Q2012

PROMETHAZINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA. AMITRIPTYLINE AS MANUFACTURED IN MAHARASHTRA, INDIA. TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA. FLUCONAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. FLUOXETINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA. FENTANYL CITRATE AS MANUFACTURED IN GRAFTON, WI. TAMSULOSIN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. ONDANSETRON HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. 180660 BEIGE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; LATEXO, TX; CARTERSVILLE, GA; HEATH, OH; DERIDDER, LA; AND ARGENTINA. 19270 BLACK POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; LATEXO, TX; CARTERSVILLE, GA; HEATH, OH; DERIDDER, LA; AND ARGENTINA. 18109 BROWN POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; LATEXO, TX; CARTERSVILLE, GA; HEATH, OH; DERIDDER, LA; AND ARGENTINA. 12083 SILVER POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; LATEXO, TX; CARTERSVILLE, GA; HEATH, OH; DERIDDER, LA; AND ARGENTINA. 13599 YELLOW POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; LATEXO, TX; CARTERSVILLE, GA; HEATH, OH; DERIDDER, LA; AND ARGENTINA. TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN DOLNI MECHOLUPY, CZECH REPUBLIC. PALONOSETRON HYDROCHLORIDE 0.50 MG SOFTGELS AS MANUFACTURED IN SOMERSET, NJ. LOVASTATIN USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. SODIUM STEARYL FUMARATE AS MANUFACTURED IN TAIWAN, R.O.C. DESTAB (TM) MAGNESIUM HYDROXIDE 95% AS MANUFACTURED BY NORTH STAR PROCESSING IN LITCHFIELD, MN FOR PARTICLE DYNAMICS, INC. ZONISAMIDE AS MANUFACTURED IN GUJARAT, INDIA. TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. MEPROBAMATE AS MANUFACTURED IN BOUND BROOK, NJ. FENTANYL AS MANUFACTURED IN GRAFTON, WI.

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4Q2012EXCEL DMF# 18195 A 18196 18197 18198 I 18199 18200 A 18201 18202 18203 18204 A 18205 18206 18207 18208 A 18209 A 18210 A 18211 18212 18213 18214 18215 A 18216 18217 A 18218 18219 18220 18221 18222 I 18223 18224 18225 18226 18227 A A A A A II II II II II 3/31/2005 3/30/2005 3/30/2005 3/31/2005 3/21/2005 CADILA HEALTHCARE LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD CADILA HEALTHCARE LTD FORMOSA LABORATORIES INC A I A A III II II II IV 3/18/2005 3/31/2005 3/30/2005 3/30/2005 2/17/2005 REXAM HEALTHCARE OFFRANVILLE SAS ASTELLAS PHARMA INC MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD FONA INTERNATIONAL INC A II III 3/30/2005 3/23/2005 SANOFI CHIMIE AMPACET CORP A A A A II II II II II 3/28/2005 3/28/2005 3/30/2005 3/30/2005 3/28/2005 CADILA HEALTHCARE LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD ARCH PHARMALABS LTD III 3/21/2005 REXAM PHARMA PACKAGING INDIA P LTD III 3/21/2005 REXAM PHARMA PACKAGING INDIA P LTD I I A II IV II III 3/22/2005 12/28/2004 3/25/2005 3/21/2005 ITF CHEMICAL LTDA FLAVORS NORTH AMERICA INC CADILA HEALTHCARE LTD REXAM PHARMA PACKAGING INDIA P LTD A I A II II II III 3/1/2005 3/28/2005 3/24/2005 3/21/2005 I II II 3/21/2005 3/22/2005 GEDEON RICHTER PLC ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD IND SWIFT LABORATORIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD APOTEX PHARMACHEM INC DYNIC USA CORP A A II II IV 3/21/2005 3/23/2005 3/22/2005 GE HEALTHCARE BIO SCIENCES CORP TEVA PHARMACEUTICAL INDUSTRIES LTD UNICHEMA CHEMIE BV STATUS Type SUBMIT DATE II 3/18/2005 HOLDER WOCKHARDT LTD SUBJECT

4Q2012

DEXTROPROPOXYPHENE NAPSYLATE (PROPOXYPHENE NAPSYLATE USP) AS MANUFACTURED IN GUJARAT, INDIA. HOLLOW FIBER TANGENTIAL CARTRIDGE AS MANUFACTURED IN WESTBOROUGH, MA. ZONISAMIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. ARLAMOL (R) E (PPG 15-STEARYL ETHER) AS MANUFACTURED IN REDCAR, U.K. FOR UNICHEMA CHEMIE BV CABERGOLINE AS MANUFACTURED IN BUDAPEST AND DOROG, HUNGARY. BUPROPION HYDROCHLORIDE USP AS MANUFACATURED IN ZHEJIANG PROVINCE, CHINA. VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN PUNJAB, INDIA. CLOBETASOL PROPIONATE AS MANUFACTURED IN SANTHIA, ITALY. ZONISAMIDE AS MANUFACTURED IN BRANTFORD, CANADA. HT 8 PLUS WHITE-INK-THERMAL TRANSFER RIBBON, MANUFACTURED IN TOKOYO, JAPAN LANSOPRAZOLE AS MANUFACTURED IN BAHIA, BRAZIL. 825.0033U CHERRY FLAVOR, ARTIFICIAL AS MANUFACTURED IN CAROL STREAM, IL. ZONISAMIDE AS MANUFACTURED IN GUJARAT, INDIA. TAMP SAFE (O) PLASTIC CONTAINER CLOSURE SYSTEM AS MANUFACTURED IN BANGALORE, INDIA. TAMP SAFE (I) PLASTIC CONTAINER CLOSURE SYSTEM AS MANUFACTURED IN BANGALORE, INDIA. TAMP SAFE (R) PLASTIC CONTAINER CLOSURE SYSTEM AS MANUFACTURED IN BANGALORE, INDIA. VENLAFAXINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA. NABUMETONE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ESCITALOPRAM OXALATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ALPRAZOLAM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. 3-PHENYL-5-METHYL ISOXAZOLE-4-CARBONYL CHLORIDE (PMIC CHLORIDE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. HYDROXOCOBALAMIN AS MANUFACTURED IN ROMAINVILLE CEDEX, FRANCE. 11748-K LAMITE 48 AS MANUFACTURED IN TERRE HAUTE, IN; LATEXO, TX; CARTERSVILLE, GA; HEATH, OH; DERIDDER, LA; RAYONG, THAILAND. OCUMETER PLUS ASSEMBLED BOTTLE AS MANUFACTURED IN OFFRANVILLE, FRANCE. FK1706 AS MANUFACTURED IN OSAKA, JAPAN. BACLOFEN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ZOLPIDEM TARTRATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. 884.458 N-C ORANGE FLAVOR, NATURAL AND ARTIFICIAL MANUFACTURED IN CAROL STREAM, IL. SIMVASTATIN AS MANUFACTURED IN GUJARAT, INDIA. TERBINAFINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. GABAPENTIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. RABEPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA. CALCITRIOL AS MANUFACTURED IN TAOYUAN, TAIWAN.

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4Q2012EXCEL DMF# 18228 A 18229 18230 18231 18232 18233 18234 18235 18236 A 18237 A 18238 A 18239 18240 I 18241 18242 18243 18244 I 18245 18246 18247 18248 18249 18250 18251 18252 18253 18254 18255 A 18256 18257 18258 18259 18260 18261 18262 A A I A A A I II II II II II II V 3/24/2005 4/11/2005 4/8/2005 4/8/2005 4/8/2005 4/11/2005 1/30/2004 A I I I A I A C A A II II II II II II II II II II II 4/5/2005 3/29/2005 4/5/2005 4/1/2005 3/29/2005 4/4/2005 3/29/2005 4/7/2005 4/7/2005 4/6/2005 4/7/2005 SMRUTHI ORGANICS LTD PCAS MAPRIMED SA FARCHEMIA SRL AUROBINDO PHARMA LTD DAICEL CHEMICAL INDUSTRIES LTD LUPIN LTD HETERO LABS LTD MYLAN LABORATORIES LTD APOTEX PHARMACHEM INC I A I II IV III II 3/31/2005 3/29/2005 4/1/2005 4/4/2005 A II II 3/29/2005 2/25/2005 II 3/31/2005 TIANJIN TIANYAO PHARMACEUTICALS CO LTD LUPIN LTD CHEMISCH-PHARMAZEUTISCHES LABOR, ROLF SACHSE GMBH CHENG FONG CHEMICAL CO LTD NICHIRIN CHEMICAL INDUSTRIES LTD SHINKO CHEMICAL CO LTD BRISTOL MYERS SQUIBB III 3/14/2005 KIRCHNER SIMON AND CO GMBH A A A A I I A II II II II III II II II 3/30/2005 3/30/2005 4/1/2005 4/1/2005 4/1/2005 3/28/2005 3/30/2005 4/1/2005 MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD NAKAMURA PRINT CO. LTD. STANDARD CHEM AND PHARM CO LTD CHEMPACIFIC CORP FINE CHEMICALS CORP PTY LTD STATUS Type SUBMIT DATE II 3/30/2005 HOLDER MYLAN LABORATORIES LTD SUBJECT

4Q2012

PANTOPRAZOLE SODIUM USP (SESQUIHYDRATE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ABACAVIR SULFATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. EFAVIRENZ AS MANUFACTURED IN ANDHRA PRADESH, INDIA. LISURIDE AS MANUFACTURED IN OPAVA, CZECH REPUBLIC. LISURIDE HYDROGENMALEATE AS MANUFACTURED IN OPAVA, CZECH REPUBLIC. POLYETHYLENE BAG OF TYPE E AS MANUFACTURED IN YAMAGUCHI, JAPAN. PRAZOSIN HYDROCHLORIDE AS MANUFACTURED IN HSIN-YING, TAIWAN. PENTOSTATIN AS MANUFACTURED IN BALTIMORE, MD. LEVALBUTEROL HYDROCHLORIDE AS MANUFACTURED IN CAPE TOWN, SOUTH AFRICA. GL45Y0060 CAP GL45 MADE OF PFA NATURE, WITH LINER MADE OF SILICONE ONE-SIDED PTFE AS MANUFACTURED IN OESTRICH-WINKEL, GERMANY. SPIRONOLACTONE USP AS MANUFACTURED IN TIANJIN, CHINA. SERTRALINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. ANAGRELIDE HYDROCHLORIDE AS MANUFACTURED IN BERLIN, FEDERAL REPUBLIC OF GERMANY. PSEUDOEPHEDRINE SULFATE AS MANUFACTURED IN TAIWAN, R.O.C. CROSCARMELLOSE SODIUM, NF AS MANUFACTURED IN HYOGO PREFECTURE, JAPAN. FK506 PLASTIC CONTAINER AS MANUFACTURED IN ISHIKAWA, JAPAN. MDX-1100 (ANTI-CXCL 10/ANTI-IP-10 HUMAN MONOCLONAL ANTIBODY) AS MANUFACTURED IN ANNANDALE, NJ. CARBIDOPA USP AS MANUFACTURED IN MAHARASHTRA, INDIA. VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN ARAMON & LIMAY, FRANCE. TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN BUENOS AIRES, ARGENTINA. MICONAZOLE BASE AS MANUFACTURED IN BERGAMO, ITALY. PENTOXIFYLLINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. AAIA AS MANUFACTURED IN NIIGATA, JAPAN. LANSOPRAZOLE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. LAMIVUDINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. VALSARTAN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. FAMOTIDINE USP AS MANUFACTURED IN ONTARIO, CANADA.

UNION QUIMICO FARMACEUTICA SA UQUIFA MELOXICAM AS MANUFACTURED IN MILAN, ITALY. SA AUROBINDO PHARMA LTD STOP INTERQUIM SA SANOFI AVENTIS CHIMIE TEVA PHARMACEUTICALS USA INC SHASUN PHARMACEUTICALS LTD NAVINTA LLC BIOGEN IDEC INC RISPERIDONE AS MANUFACTURED IN BARCELONA, SPAIN. RIMONABANT AS MANUFACTURED IN SISTERON, FRANCE AND DARTFORD, ENGLAND. AMOXICILLIN SODIUM AS MANUFACTURED IN MEXICO, MO. OLANZAPINE AS MANUFACTURED IN CUDDALORE, INDIA. IRON SUCROSE COMPLEX AS MANUFACTURED IN ANDHRA PRADESH, INDIA. RITUXAN (RITUXIMAB) (ESUB) MANUFATURED IN SAN DIEGO, CA

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4Q2012EXCEL DMF# 18263 I 18264 I 18265 A 18266 I 18267 I 18268 A 18269 18270 A 18271 A 18272 I 18273 A 18274 I 18275 A 18276 A 18277 18278 18279 18280 18281 I 18282 I 18283 18284 18285 18286 18287 18288 18289 18290 A 18291 A II 4/20/2005 HETERO LABS LTD I A A A A A A II II II II II II V III 4/14/2005 4/12/2005 4/8/2005 4/19/2005 4/19/2005 4/15/2005 12/23/2004 4/21/2005 MEDICHEM SA DIXIE CHEMICAL CO INC SCI PHARMTECH INC UNIMARK REMEDIES LTD SMS PHARMACEUTICALS LTD EXCELLA GMBH DANIPHARM APS INTERNATIONAL CONVERTER LLC II 3/31/2005 A A A A II II II II III 4/12/2005 4/11/2005 4/13/2005 4/18/2005 4/15/2005 III 4/4/2005 SHANGHAI HAICHANG MEDICAL PLASTIC PLANT BACHEM AG SAFC BIOSCIENCES CATALENT PHARMA SOLUTIONS LLC SUN PHARMACEUTICAL INDUSTRIES LTD DUPONT PACKAGING AND INDUSTRIAL POLYMERS TORONTO RESEARCH CHEMICALS INC III 2/11/2005 COPE ALLMAN JAYCARE LTD III 3/23/2005 II 4/13/2005 DAINIPPON SUMITOMO PHARMA AMERICA INC JAYCARE LTD III 2/11/2005 II 3/31/2005 ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTD JAYCARE LTD I II II 4/10/2005 3/31/2005 CF PHARMA LTD LUPIN LTD TOPIRAMATE AS MANUFACTURED IN BUDAPEST, HUNGARY. II 4/11/2005 SIGNA SA DE CV III 2/11/2005 II 4/11/2005 CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD COPE ALLMAN JAYCARE LTD GLYBURIDE USP AS MANUFACTURED IN TAIPEI HSIEN, TAIWAN R.O.C. III 4/8/2005 BEACON CONVERTERS INC II 4/11/2005 ELAN DRUG DELIVERY INC STATUS Type SUBMIT DATE IV 4/4/2005 HOLDER FONA INTERNATIONAL INC SUBJECT

4Q2012

884.0028U FONATECH (TM) JUICY ORANGE FLAVOR, NATURAL AND ARTIFICIAL AS MANUFACTURED IN CAROL STREAM, IL. N1506 NANOCRYSTAL (R) COLLOIDAL DISPERSION AS MANUFACTURED IN KING OF PRUSSIA, PA. PHARMACEUTICAL PACKAGING MATERIAL AS MANUFACTURED IN SADDLE BROOK, NJ.

360ML OPTHALMIC CYLINDRICAL BOTTLE WITH 18MM NOZZLE & 18MM OPTHALMIC CLOSURE AS MANUFACTURED IN NEWCASTLE UPON TYNE, UNITED KINGDOM. TERAZOSIN HYDROCHLORIDE DIHYDRATE USP AS MANUFACTURED IN TOLUCA, MEXICO.

VENLAFAXINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. PSEUDOEPHEDRINE HYDROCHLORIDE USP AS MANUFACTURED IN ZHEJIANG, CHINA. 110ML OPTHALMIC CYLINDRICAL BOTTLE WITH 18MM NOZZLE & 18MM OPTHALMIC CLOSURE AS MANUFACTURED IN NEWCASTLE UPON TYNE, UNITED KINGDOM. SMP-986 AS MANUFACTURED IN OSAKA, JAPAN. 300ML SYRUP BOTTLE AS MANUFACTURED IN NEWCASTLE UPON TYNE, UNITED KINGDOM. 250ML OPHTHALMIC FLAT BOTTLE WITH 18MM NOZZLE & 18MM OPHTHALMIC CLOSURE AS MANUFACTURED IN NEWCASTLE UPON TYNE, UNITED KINGDOM. PACKAGING COMPONENTS (BOTTLES, CAPS AND LINERS) AS MANUFACTURED IN SHANGHAI, CHINA. GLUCAGON AS MANUFACTURED IN BUBENDORF, SWITZERLAND. SERUM-FREE MEDIA SUPPLEMENT PART A (100 X) AS MANUFACTURED IN DENVER, PA. NEORAL 25 MG AND 100 MG SOFTGELS AS MANUFACTURED IN ST. PETERSBURG, FL. DISODIUM PAMIDRONATE BP AS MANUFACTURED IN MAHARASHTRA, INDIA. DUPONT SECURITY FILMS AS MANUFACTURED IN FEDERAL REPUBLIC OF GERMANY AND AUSTRIA. 2-CHLORO-2',3'-O-ISOPROPYLIDENEADENOSINE-5'-N-ETHYLCARBOXAMIDE AS MANUFACTURED IN ONTARIO, CANADA. PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN GIRONA, SPAIN. TP1 AS MANUFACTURED IN PASADENA, TX. DIVALPROEX SODIUM AS MANUFACTURED IN TAOYUAN, TAIWAN R.O.C. MELOXICAM AS MANUFACTURED IN GUJARAT, INDIA. SUMATRIPTAN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ROPIVACAINE HYDROCHLORIDE AS MANUFACTURED IN FEUCHT, GERMANY. AVECIA BILLINGHAM SITE IN BILLINGHAM, U.K. LAMINATED PRODUCTS FOR PACKAGING MATERIAL AS MANUFACTURED IN CALDWELL AND BELPRE, OH; AND LUKA, MS. ZIDOVUDINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

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4Q2012EXCEL DMF# 18292 18293 18294 I 18295 18296 18297 A 18298 18299 I 18300 18301 18302 A 18303 I 18304 I 18305 A 18306 18307 18308 18309 I 18310 18311 A 18312 18313 18314 18315 18316 18317 A 18318 18319 18320 18321 18322 A 18323 A II 5/26/2005 IPCA LABORATORIES LTD A A N N III 4/20/2005 II II 4/29/2005 5/6/2005 A I I A A II II II III III II 4/27/2005 4/26/2005 4/26/2005 4/28/2005 4/13/2005 4/27/2005 SHASUN PHARMACEUTICALS LTD HUASHU PHARMACEUTICAL CORP HUASHU PHARMACEUTICAL CORP NYPRO INC POLYONE CORP I III II 4/27/2005 4/29/2005 A C A II II III II 4/24/2005 4/26/2005 4/25/2005 4/20/2005 DIVIS LABORATORIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD BAXTER HEALTHCARE CORP III 3/29/2005 INEOS ABS USA CORP II 4/14/2005 STRAINRITE II 4/14/2005 STRAINRITE I N III 4/20/2005 II 10/29/2004 GITANJALI CHEMICALS PVT LTD NOT AN ASSIGNED NUMBER CENTURY PLASTICS INC A III II 4/22/2005 4/18/2005 SIEGWERK USA CO POLYCARBON INDUSTRIES INC I I II III II 4/21/2005 4/13/2005 4/21/2005 STATUS Type SUBMIT DATE A A III II II 4/18/2005 4/11/2005 4/20/2005 HOLDER REXAM HEALTHCARE OFFRANVILLE SAS LONZA LTD BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG STRYKER BIOTECH INC TRUDELL MEDICAL INTERNATIONAL AMINO CHEMICALS LTD SUBJECT

4Q2012

KERPHARM EYE DROPPERS SETS AS MANUFACTURED IN OFFRANVILLE, FRANCE. NIACIN USP GRANULAR SPECIAL AS MANUFACTURED IN VISP, SWITZERLAND. METHSCOPOLAMINE NITRATE AS MANUFACTURED IN INGELHEIM AM RHEIN, FEDERAL REPUBLIC OF GERMANY. OP-1 AS MANUFACTURED IN WEST LEBANON, NH. TOP MOUNT DOSE INDICATOR AS MANUFACTURED IN ONTARIO, CANADA. PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN MARSA, MALTA. PRINTING INK AS MANUFACTURED IN DES MOINES, IA AND BOILING SPRINGS, SC. PCI-8014 NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN LEOMINSTER, MA. 1-(2,6-DICHLOROPHENYL)-2-INDOLINONE CONTINUOUS THREAD CLOSURES (CAPS) FOR PHARMACEUTICAL & FOOD CONTAINERS AS MANUFACTURED IN SIMPSONVILLE, SC. MD-2X-6XX: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN AUBURN, MAINE. MD-1X-6XX: BAG TYPE CLARIFIER FOR ONE-TIME USE AS MANUFACTURED IN AUBURN, MAINE. LUSTRAN ABS M301 FC 000000 AND LUSTRAN ABS M301 FC 018646 AS MANUFACTURED IN GERMANY, ITALY, SPAIN AND U.K. BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. EPIRUBICIN HYDROCHLORIDE LYOPHILIZED AS MANUFACTURED IN VERCELLI, ITALY. AVIVA CONTAINER CLOSURE SYSTEM AS MANUFACTURED IN MARION, NC.

ZHEJIANG APELOA PHARMACEUTICAL CO SIMVASTATIN USP BULK AS MANUFACTURED IN ZHEJIANG, CHINA. LTD KUNSTSTOFFWERK KREMSMUNSTER GMBH PP 28 CAPS T/E CRC AS MANUFACTURED IN KREMSMUNSTER, AUSTRIA. TORRENT PHARMACEUTICALS LTD SERTRALINE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN GUJARAT, INDIA. IBUPROFEN SODIUM DIHYDRATE AS MANUFACTURED IN PONDICHERRY, INDIA. DOXYCYCLINE MONOHYDRATE AS MANUFACTURED IN SHIJIAZHUANG, CHINA. DOXYCYCLINE HYCLATE AS MANUFACTURED IN SHIJIAZHUANG, CHINA. ORLISTAT 60 MG PORTABLE PACKAGE (R) AS MANUFACTURED IN CLINTON, MA. CC00039994BG 310NV33236NOENXIPPMB AS MANUFACTURED IN MANCHESTER, U.K.

PHARMACEUTICAL WORKS POLPHARMA SA CYCLOBENZAPRINE HYDROCHLORIDE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND. SIMS SRL LIDOCAINE BASE AS MANUFACTURED IN FLORENCE, ITALY. SYN TECH CHEM AND PHARM CO LTD NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER ADVANCED SCIENTIFICS INC INJECTION MOLDED AUTOCLAVABLE WINGED SPIKE PORT AS MANUFACTURED IN MILLERSBURG, PA. METFORMIN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MADHYA PRADESH (MP), INDIA. PHENYLEPHRINE HYDROCHLORIDE AS MANUFACTURED IN HSIN-YING, TAIWAN R.O.C.

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4Q2012EXCEL DMF# 18324 A 18325 18326 18327 A 18328 18329 18330 18331 18332 A 18333 18334 18335 18336 18337 A 18338 18339 18340 18341 18342 18343 18344 18345 A 18346 18347 18348 18349 18350 A 18351 18352 18353 18354 18355 A 18356 18357 A 18358 A IV 5/16/2005 NATURAL CAPSULES LTD A II IV 5/18/2005 5/16/2005 A A I N II 4/28/2005 III II II 5/13/2005 5/13/2005 5/17/2005 BOREALIS AG FARMABIOS S P A GEDEON RICHTER LTD NOT AN ASSIGNED NUMBER YANTAI DONGCHENG BIOCHEMICALS CO LTD SUN PHARMACEUTICAL INDUSTRIES LTD NATURAL CAPSULES LTD A A A A II II II III III 5/12/2005 5/11/2005 5/13/2005 5/12/2005 5/12/2005 HETERO DRUGS LTD DR REDDYS LABORATORIES LTD DR REDDYS LABORATORIES LTD DYNIC USA CORP EXXONMOBIL CHEMICAL CO A A A C A A A II III II II II II IV II 5/9/2004 5/10/2005 5/9/2005 5/9/2005 5/9/2005 5/24/2005 5/5/2005 2/11/2005 HETERO LABS LTD GRAHAM PACKAGING CO LP SANOFI AVENTIS DEUTSCHLAND GMBH TEVA PHARMACEUTICAL INDUSTRIES LTD DR REDDYS LABORATORIES LTD CHIROGATE INTERNATIONAL INC RANQ REMEDIES PVT LTDY FIDIA FARMACEUTICI SPA I I A A III II II II III 4/28/2005 4/27/2005 5/6/2005 5/9/2005 4/15/2005 TECH GROUP EUROPE VENKAT PHARMA LTD SCINOPHARM TAIWAN LTD CAMBRIDGE MAJOR LABS INC HUMPHREY COSBURN PLASTICS A A A A V II II II III 1/31/2005 5/9/2005 5/5/2005 4/30/2005 4/29/2005 DSM BIOLOGICS CO BV USV LIMITED SMRUTHI ORGANICS LTD AUROBINDO PHARMA LTD BAXA CORP I A II III II 4/15/2005 3/7/2005 5/3/2005 XIAN LIBANG PHARMACEUTICAL CO LTD PLASPAK QP PTY LIMITED TEVA PHARMACEUTICAL INDUSTRIES LTD STATUS Type SUBMIT DATE III 4/28/2005 HOLDER RELIANCE INDUSTRIES LTD SUBJECT

4Q2012

POLYETHYLENE (PE) RELENE B56003 RAW MATERIAL AS MANUFACTURED IN GUJARAT, INDIA. DIATRIZOIC ACID BULK AS MANUFACTURED IN SHAANXI, CHINA. PLASTIC TABLET BOTTLES AS MANUFACTURED IN VIRGINIA QLD, AUSTRALIA. ALENDRONATE MONOSODIUM TRIHYDRATE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD MAMMALIAN MANUFACTURING AREAS IN AP GRONINGEN, THE NETHERLANDS. REPAGLINIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA. METFORMIN HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA. CEFADROXIL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ORAL DISPENSER ACCESSORIES AS MANUFACTURED IN ENGLEWOOD, CO FOR BAXA CORP NOVEL DUAL STRIP DPI AS MANUFACTURED IN DUBLIN, IRELAND. OMEPRAZOLE PELLETS 8.5% W/W AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ANASTROZOLE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN R.O.C. DEXRAZOXANE AS MANUFACTURED IN GERMANTOWN, WI. 250ML WHITE LDPE FLAT OVAL BOTTLE 24/410 AS MANUFACTURED IN ONTARIO, CANADA. RAMIPRIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA. PLASTIC BOTTLES AS MANUFACTURED IN BELVIDERE, NJ. CLOBAZAM AS MANUFACTURED IN FRANKFURT AM MAIN, GERMANY. QUETIAPINE FUMARATE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. ESCITALOPRAM OXALATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. LATANOPROST AS MANUFACTURED IN TAOYUAN HSIEN, TAIWAN R.O.C. MICROCRYSTALLINE CELLULOSE USP AS MANUFACTURED IN SINNAR, INDIA. PENTAZOCINE HYDROCHLORIDE AS MANUFACTURED IN GARBAGNATE MILANESE, ITALY. TOPIRAMATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. METOPROLOL SUCCINATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. HL35 INK-THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN. CHLORINATED ISOBUTYLENE-ISOPRENE RUBBER AS MANUFACTURED IN HOUSTON, TX, JAPAN AND ENGLAND. BORMED HE7541-PH AS MANUFACTURED IN BURGHAYSEN, GERMANY HALCINONIDE MICRONIZED USP AS MANUFACTURED IN PAVIA, ITALY. LAMOTRIGINE AS MANUFACTURED IN BUDAPEST AND DOROG, HUNGARY. HEPARIN SODIUM, INJECTABLE GRADE NON-STERILE BULK DRUG AS MANUFACTURED IN SHANDONG PROVINCE, CHINA. LAMOTRIGINE AS MANUFACTURED IN MAHARASHTRA, INDIA. EMPTY HARD CELLULOSE CAPSULES (VEGE CAPSULES) AS MANUFACTURED IN BANGALORE, INDIA. EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN BANGALORE, INDIA.

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4Q2012EXCEL DMF# 18359 18360 18361 18362 A 18363 A 18364 A 18365 18366 18367 18368 18369 A 18370 18371 A 18372 I 18373 18374 A 18375 A 18376 18377 18378 18379 18380 A 18381 18382 18383 A 18384 18385 18386 18387 18388 18389 18390 A A A A A A I II II II II II II II 5/27/2005 5/31/2005 5/21/2005 5/27/2005 6/3/2005 6/1/2005 5/31/2005 A A II II II 5/27/2005 5/27/2005 6/1/2005 A A A A III III II II II 5/21/2005 5/21/2005 5/26/2005 5/21/2005 5/25/2005 II 5/26/2005 PRIME EUROPEAN THERAPEUTICS SPA EUTICALS SPA COPE ALLMAN JAYCARE LTD COPE ALLMAN JAYCARE LTD CIPLA LTD IND SWIFT LABORATORIES LTD ZHEJIANG XIANJU PHARMACEUTICAL CO LTD DR REDDYS LABORATORIES LTD BASF CORP ERREDUE SPA INNOVATIVE CHEMICAL AND LIFE SYNTHON BV CRYSTAL PHARMA SAU AUROBINDO PHARMA LTD DOCTOR REDDYS LABORATORIES LTD NATCO PHARMA LTD DANIPHARM A S EBAB AS MANUFACTURED IN ORIGGIO, ITALY. A II II 5/24/2005 5/26/2005 CATALENT PHARMA SOLUTIONS LLC USV LIMITED III 5/25/2005 MEYERS COLOUR COMPOUNDS LTD A V III 5/11/2005 11/16/2004 WEST PHARMACEUTICAL SERVICES INC UNITED CLOSURES AND PLASTICS PLC I I A A IV IV IV II V 5/16/2005 5/16/2005 5/19/2005 5/18/2005 4/4/2005 ION EXCHANGE (INDIA) LTD ION EXCHANGE (INDIA) LTD WILD FLAVORS INC TRACE RADIOCHEMICALS INC A BIO PHARMA PTE LTD IV 5/16/2005 ION EXCHANGE INDIA LTD II 4/14/2005 CKD BIO CORP STATUS Type SUBMIT DATE A A A IV II II II 5/16/2005 6/26/2007 5/20/2005 4/14/2005 HOLDER NATURAL CAPSULES LTD HETERO DRUGS LTD UNIMARK REMEDIES LTD CKD BIO CORP SUBJECT

4Q2012

EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN PONDICHERRY, INDIA. TORSEMIDE AS MANUFACTURED ANDHRA PRADESH INDIA CEPHALEXIN USP AS MANUFACTURED IN GUJARAT, INDIA. CLAVULANATE POTASSIUM WITH SILICON DIOXIDE IN THE RATIO 1:1, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN KYUNGGI-DO, SOUTH KOREA. CLAVULANATE POTASSIUM WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO 1:1, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN KYUNGGI-DO, SOUTH KOREA. INDION 254 SODIUM POLYSTYRENE SULFONATE USP AS MANUFACTURED IN GUJARAT, INDIA. INDION 204 AS MANUFACTURED IN GUJARAT, INDIA. INDION 234 AS MANUFACTURED IN GUJARAT, INDIA. NATURAL BANANA FLAVOR WONF #FAFH079 AS MANUFACTURED IN ERLANGER, KY. SODIUM IODIDE (I-123) RADIOCHEMICAL AS MANUFACTURED IN DENTON, TX. CGMP MANUFACTURING FACILITY FOR PRODUCTION OF BIOLOGICS FOR CLINICAL TRIALS IN SINGAPORE. WESTAR(R) RS PROCESS IN ESCHWEILER, GERMANY. PP28 MEDI-LOC TAMPER-EVIDENT CLIC-LOC CLOSURES AS MANUFACTURED IN NORWICH, ENGLAND. MEYERS COLOUR COMPOUNDS WHITE MMB9524 AS MANUFACTURED IN ONTARIO, CANADA. NIMODIPINE 30MG SOFTGELS AS MANUFACTURED IN SOMERSET, NJ. BICALUTAMIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA

250ML PET ROUND PACKER AS MANUFACTURED IN NEWCASTLE UPON TYNE, U.K. 500ML PET ROUND PACKER AS MANUFACTURED IN NEWCASTLE UPON TYNE, U.K. SALMETEROL XINAFOATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. PIOGLITAZONE HYDROCHLORIDE AS MANUFACATURED IN PUNJAB, INDIA. DELTA CORTISONE ACETATE AS MANUFACTURED IN ZHEJIANG, CHINA. OXCARBAZEPINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. POLOXALENE USP AS MANUFACTURED IN WASHINGTON, NJ. OXCARBAZEPINE AS MANUFACTURED IN ISSO, ITALY. SIMVASTATIN AS MANUFACTURED IN ZHEJIANG, CHINA FOR SYNTHON BV. DORZOLAMIDE HYDROCHLORIDE AS MANUFACTURED IN VALLADOLID, SPAIN. CEFAZOLIN SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. MESALAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. LETROZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. LACTULOSE PURUM LIQUIDUM AS MANUFACTURED IN NIBE, DENMARK.

CHONGQING PHARMACEUTICAL RESEARCH IRON SUCROSE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN INSTITUTE CO LTD CHONGQING, CHINA FOR CHEMWERTH INC Page

546

4Q2012EXCEL DMF# 18391 18392 18393 I 18394 18395 18396 18397 18398 18399 18400 18401 18402 I 18403 A 18404 18405 I 18406 A 18407 A 18408 18409 A 18410 A 18411 18412 18413 A 18414 18415 18416 18417 A 18418 A 18419 A 18420 A 18421 A II 6/9/2005 II 6/9/2005 JOHNSON MATTHEY PHARMACEUTICAL MATERIALS CIPLA LTD II 6/7/2005 WACKER CHEMIE AG III 6/10/2005 PLASTIAPE SPA A A A III III III II 6/10/2005 5/24/2005 5/26/2005 6/9/2005 A A II II II 6/9/2005 6/9/2005 6/9/2005 SUN PHARMACEUTICAL INDUSTRIES LTD DR REDDYS LABORATORIES LTD ZIBO XINHUA PERRIGO PHARMACEUTICAL CO LTD SHRIJI POLYMERS INDIA LTD BERRY PLASTICS CORP SCHWEIZ SCHOTT AG H LUNDBECK AS III 6/3/2005 3M DRUG DELIVERY SYSTEMS A II II 6/7/2005 6/8/2005 DR REDDYS LABORATORIES LTD SANOFI CHIMIE IV 3/15/2005 MANE INC IV 3/23/2005 MANE INC A II II 6/7/2005 6/2/2005 SANDOZ GMBH CIPLA LTD MYCOPHENOLIC ACID PURE AS MANUFACTURED IN TYROL, AUSTRIA. II 6/2/2005 BAYER PHARMA AG A A A A A A A A II II II II II III II II II 6/3/2005 5/27/2005 6/3/2005 5/23/2005 6/1/2005 6/1/2005 6/10/2005 5/22/2005 6/6/2005 STATUS Type SUBMIT DATE A A II II II 5/31/2005 6/3/2005 5/11/2005 HOLDER JOHNSON MATTHEY PHARMA SERVICES NATCO PHARMA LTD CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO LTD NATCO PHARMA LTD DR REDDYS LABORATORIES LTD URQUIMA SA POLYMED THERAPEUTICS INC DAITO CORP ADVANEX EUROPE LTD CML EUROPE BV AUROBINDO PHARMA LTD MOREPEN LABORATORIES LTD SUBJECT

4Q2012

TALAPORFIN SODIUM AS MANUFACTURED IN DEVENS AND NORTH ANDOVER, MA. TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. DIRITHROMYCIN USP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN INNER MONGOLIA, CHINA. SALMETEROL XINAFOATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. GLIMEPIRIDE, MICRONISED AS MANUFACTURED IN BARCELONA, SPAIN. PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, CHINA. AZELASTINE HYDROCHLORIDE AS MANUFACTURED IN TOYAMA, JAPAN. GSK TORSION HUB SPRINGS AS MANUFACTURED IN NOTTINGHAMSHIRE, U.K. PHENELZINE SULFATE (ESUB) AS MANUFACTURED IN AA WEERT, THE NETHERLANDS. NEVIRAPINE HEMIHYDRATE UPS AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ATORVASTATIN CALCIUM AMORPHOUS, BULK SUBSTANCE AS MANUFACTURED IN HIMACHAL PRADESH, INDIA. LEVONORGESTREL (DCM) AS MANUFACTURED IN BERLIN AND BERGKAMEN, GERMANY.

SERTRALINE HYDROCHLORIDE (FORM-I) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. BANANA FLAVOR E_0501695 AS MANUFACTURED IN BAR SUR LOUP, FRANCE FOR MANE INC ARANCIA FLAVOR E_9940619/01 AS MANUFACTURED IN BAR SUR LOUP, FRANCE FOR MANE INC DUTASTERIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. DRONEDARONE HYDROCHLORIDE AS MANUFACTURED IN SISTERON CEDEX AND ARAMON, FRANCE. 3M #9773 POLYOLEFIN FOAM TAPE AS MANUFACTURED IN BROOKINGS, SD FOR 3M DRUG DELIVERY SYSTEMS DIVISION MODAFINIL AS MANUFACTURED IN GUJARAT, INDIA. ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. IBUPROFEN USP DRUG SUBSTANCE AS MANUFACTURED IN SHANDONG PROVINCE, CHINA. HIGH DENSITY POLYETHYLENE BOTTLES (ESUB) AS MANUFACTURED IN M.P., INDIA. PRODUCT 41809-26 AS MANUFACTURED IN COLUMBUS, GA. TOPPAC (TM) SYRINGE AS MANUFACTURED IN ST. GALLEN, SWITZERLAND. GABOXADOL MONOHYDRATE AS MANUFACTURED IN NYKOEBING SJ. AND COPENHAGEN, DENMARK. DRY POWDER INHALER (CYCLOHALER) MODEL 8 AS MANUFACTURED IN LECCO, ITALY. ELASTOSIL(R) LR 3003/20 A/B - RAL 6010 AS MANUFACTURED IN BURGHAUSEN, GERMANY. SUFENTANIL BASE AS MANUFACTURED IN WEST DEPTFORD, NJ. LAMOTRIGINE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA.

Page 547

4Q2012EXCEL DMF# 18422 A 18423 18424 I 18425 I 18426 18427 18428 18429 A 18430 18431 A 18432 18433 A 18434 18435 18436 A 18437 A 18438 A 18439 A 18440 18441 18442 18443 A 18444 18445 I 18446 18447 18448 18449 18450 A 18451 A III 6/10/2005 BASELL POLYOLEFINE ITALIA SRL LYONDELLBASELL INDUSTRIES CO I A A A II II II II IV 6/23/2005 6/15/2005 6/23/2005 6/23/2005 6/22/2005 GEDEON RICHTER LTD JOHNSON MATTHEY FINLAND LTD OLON SPA BIOCON LTD TAKASAGO INTERNATIONAL CORP RISPERIDONE AS MANUFACTURED IN BUDAPEST, HUNGARY. SMOPEX-105 AS MANUFACTURED IN TURKU, FINLAND. THALIDOMIDE AS MANUFACTURED IN MILAN, ITALY. SIMVASTATIN AS MANUFACTURED IN BANGALORE, INDIA. A II II 6/21/2005 5/30/2005 CF PHARMA LTD IRVINE SCIENTIFIC SALES CO A A A II II II IV 6/22/2005 6/10/2005 6/21/2005 6/21/2005 II 6/20/2005 V 5/18/2005 II 6/17/2005 A A II II II 6/16/2005 6/17/2005 6/17/2005 HETERO DRUGS LTD JOHNSON MATTHEY PHARMA SERVICES I III II 6/6/2005 6/16/2005 MAC CLOSURES INC TEVA PHARMACEUTICAL INDUSTRIES LTD A II II 6/10/2005 6/15/2005 LUPIN LTD WACKER CHEMIE AG A A A II III II II 6/15/2005 5/24/2005 6/8/2005 6/13/2005 SUN PHARMACEUTICAL INDUSTRIES LTD SONOLITE PLASTICS CORP INDUSTRIALE CHIMICA SRL WACKER CHEMIE AG III 1/14/2005 KLOCKE VERPACKUNGS-SERVICE GMBH A III II 6/6/2005 5/19/2005 HUMPHREY COSBURN PLASTICS WELDING GMBH & CO KG STATUS Type SUBMIT DATE II 6/9/2005 HOLDER CIPLA LTD SUBJECT

4Q2012

DONEPEZIL HYDROCHLORIDE (ESUB) (FORM-I) AS MANUFACTURED IN BANGALORE, INDIA 20MM GREEN M14102 PP OVERCAP AS MANUFACTURED IN ONTARIO, CANADA. CRUDE HEPARIN SODIUM AS MANUFACTURED BY HUAIAN WELLKONG BIOCHEMISTRY CO. LTD. IN JIANGSU, CHINA FOR WELDING GMBH & CO KG. NOA44X NOVEL PACKAGING SYSTEM AS MANUFACTURED IN WEINGARTEN, FEDERAL REPUBLIC OF GERMANY. GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA. ENEMA APPLICATOR ASSEMBLY AS MANUFACTURED IN GLOUCESTER, MA. IDEBENONE AS MANUFACTURED IN VARESE, ITALY. ELASTOSIL(R) LR 3003/30 A/B - RAL 6010 AS MANUFACTURED IN BURGHOUSEN, GERMANY. ZOLPIDEM TARTRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. ELASTOSIL(R) LR 3003/70 A/B - RAL 6010 AS MANUFACTURED IN BURGHAUSEN, GERMANY. FLIP TOP CHILD RESISTANT CONTAINER AS MANUFACTURED IN QUEBEC, CANADA. LEVALBUTEROL HYDROCHLORIDE AS MANUFACTURED IN CARONNO PERTUSELLA (VA), ITALY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD CEFPROZIL MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CANGRELOR AS MANUFACTURED IN DEVENS AND NORTH ANDOVER, MA.

UNION QUIMICO FARMACEUTICA SA UQUIFA MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN MILAN, ITALY. SA SAFC BIOSCIENCES INC EX-CELL(TM) 302 CHO, SERUM-FREE MEDIUM, W/O L-GLUTAMINE, W/O PHENOL RED, W/O NAHC03 AS MANUFACTURED IN DENVER, PA. PFIZER INC HYDROXYPROPYL METHYLCELLULOSE ACETATE SUCCINATE (HPMCAS) AS MANUFACTURED IN NEW LONDON, CT. UNION QUIMICO FARMACEUTICA SA UQUIFA LAMOTRIGINE AS MANUFACTURED IN BARCELONA, SPAIN. SA DR REDDYS LABORATORIES LTD ATOMOXETINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. JOHNSON MATTHEY FINLAND LTD BIOCON LTD DOW CORNING CORP SMOPEX-102 AS MANUFACTURED IN TURKU, FINLAND. TACROLIMUS AS MANUFACTURED IN BANGALORE, INDIA. DOW CORNING(R) UNFILLED SILICONE ELASTOMER GELS AS MANUFACTURED IN HEMLOCK, MI. ATRACURIUM BESYLATE AS MANUFACTURED IN BUDAPEST, HUNGARY. KI NSM-3 (KIRIN) POWDER, A CELL CULTURE MEDIUM AS MANUFACTURED IN SANTA, CA.

TAK-051366 INTENSATES(R) NATURAL & ARTIFICIAL PEPPERMINT MASK (686) AS MANUFACTURED IN TETERBORO, NJ. PURELL 2410 T AS MANUFACTURED IN WESSELING, GERMANY FOR BASELL POLYOLEFINE ITALIA SPA

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4Q2012EXCEL DMF# 18452 A 18453 18454 18455 18456 I 18457 18458 I 18459 18460 18461 A 18462 I 18463 18464 18465 18466 18467 18468 A 18469 18470 A 18471 18472 A 18473 18474 18475 18476 18477 18478 A 18479 A 18480 18481 18482 18483 18484 A C A A A II II II II III 7/6/2005 7/5/2005 7/6/2005 7/6/2005 7/5/2005 UQUIFA MEXICO SA DE CV DIVIS LABORATORIES LTD BIOCON LTD STERLING SRL INDIAN SCIENTIFIC GLASS INDUSTRIES II 6/28/2005 A N A I I III III III II 7/1/2005 6/28/2005 6/28/2005 6/28/2005 III 6/25/2005 A II II 6/30/2005 6/30/2005 DR REDDYS LABORATORIES LTD JOHNSON MATTHEY PHARMACEUTICAL MATERIALS POLYONE CORP NOT AN ASSIGNED NUMBER MGJ POLIMERI EUROPA FRANCE POLIMERI EUROPA FRANCE NANTONG JINGHUA PHARMACEUTICAL CO LTD SAFC BIOSCIENCES INC A II II 6/28/2005 6/30/2005 AUROBINDO PHARMA LTD APOTEX PHARMACHEM INC A A A A I IV II II II II II 6/4/2005 6/29/2005 6/24/2005 6/29/2005 6/29/2005 6/29/2005 DOW CHEMICAL CO SYMED LABS LTD NEULAND LABORATORIES LTD APOTEX PHARMACHEM INC DR REDDYS LABORATORIES LTD DR REDDYS LABORATORIES LTD II 6/29/2005 CHEMWERTH INC A N II 6/30/2005 II 6/27/2005 EXCELLA GMBH NOT AN ASSIGNED NUMBER DAIICHI SANKYO CO LTD A II II 6/27/2005 6/24/2005 SANDOZ GMBH MEDAREX INC A A A II II V V 6/16/2005 6/18/2005 6/16/2005 4/15/2005 STATUS Type SUBMIT DATE II 5/28/2005 HOLDER DONGYING TIANDONG PHARMACEUTICAL CO LTD AUROBINDO PHARMA LTD AUROBINDO PHARMA LTD WEST PHARMACEUTICAL SERVICES INC DIVISION OF AIDS NIAID SUBJECT

4Q2012

ENOXAPARIN SODIUM (NON-STERILE BULK FORM) AS MANUFACTURED IN SHANDONG, CHINA. CEFUROXIME ACID AS MANUFACTURED IN ANDHRA PRADESH, INDIA. NELFINAVIR MESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. WESTAR(R) RS PROCESS IN JURONG, SINGAPORE. CURRICULA VITAE (CV) FOR ACUTE INFECTION AND EARLY DISEASE RESEARCH PROGRAM (AIEDRP) INVESTIGATORS. CEFDINIR AS MANUFACTURED IN TYROL, AUSTRIA. MDX-1303 VALORTIM (TM), ANTI-BACILLUS ANTHRACIS PROTECTIVE ANTIGEN HUMAN MONOCLONAL ANTIBODY AS MANUFACTURED IN ANNANDALE, NJ. DEFEROXAMINE MESYLATE (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY. SUN11031 (HUMAN GHRELIN) DRUG SUBSTANCE AS MANUFACTURED IN TOYAMA AND GUNMA, JAPAN FOR ASUBIO PHARMA CO LTD DOXORUBICIN HYDROCHLORIDE USP (NON-STERILE, BULK DRUG SUBSTANCE) AS MANUFACTURED IN DISTRICT BHARUCH, INDIA FOR CHEMWERTH INC WALOCEL(R) HM HYPROMELLOSE USP AS MANUFACTURED IN BOMLITZ, GERMANY. GEMFIBROZIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CIPROFLOXACIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. TORSEMIDE USP AS MANUFACTURED IN ONTARIO, CANADA. TRANDOLAPRIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ATORVASTATIN CALCIUM (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CEFPROZIL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. MIDODRINE HYDROCHLORIDE AS MANUFACTURED BY SIGNA S.A. DE C.V. AND APOTEX PHARMACHEM INC IN TOLUCA, MEXICO AND ONTARIO, CANADA. ARIPIPRAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. OXYCODONE HYDROCHLORIDE AS MANUFACTURED IN WEST DEPTFORD, NJ. CC00015929WE/DR AS MANUFACTURED IN ST. PETERS, MO. CORELEN/TRESYLENE LINERS AS MANUFACTURED IN CHAZAY D'AZERGUES, FRANCE. RIBLENE MP31 AS MANUFACTURED IN MARDYCK, FRANCE. FLEXIRENE MS26 AS MANUFACTURED IN MARDYCK, FRANCE. FLUOROURACIL USP AS MANUFACTURED IN JIANGSU, CHINA. EX-CELL(TM) 325 PF CHO, SERUM-FREE MEDIUM, PROTEIN-FREE (MODIFIED), W/O LGLUTAMINE, W/O PHENOL RED, W/O NAHC03 AS MANUFACTURED IN DENVER, PA. PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN MORELOS, MEXICO. NIACIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. REPAGLINIDE AS MANUFACTURED IN BANGALORE, INDIA. FINASTERIDE AS MANUFACTURED IN PERUGIA, ITALY. NEUTRAL GLASS AMPOULES AS MANUFACTURED IN GUJARAT, INDIA.

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4Q2012EXCEL DMF# 18485 A 18486 A 18487 18488 18489 18490 18491 18492 A 18493 18494 A 18495 18496 18497 I 18498 A 18499 18500 18501 18502 18503 18504 18505 A 18506 A 18507 A 18508 18509 A 18510 18511 18512 18513 18514 18515 18516 18517 I A A A N I A A II III III 7/3/2005 4/4/2005 4/4/2005 II III III III 7/5/2005 7/14/2005 7/14/2005 7/14/2005 PCAS FARMACAP INDUSTRIA E COMERCIO LTDA COMPANHIA INDUSTRIAL DE VIDROS - CIV WHEATON BRASIL VIDROS LTDA NOT AN ASSIGNED NUMBER CADILA PHARMACEUTICALS LTD DEX PLASTOMERS DEX PLASTOMERS CARVEDILOL AS MANUFACTURED IN GUJARAT, INDIA. STAMYLEX 5119S AS MANUFACTURED IN AP GELEEN, THE NETHERLANDS. STAMYLEX 2258 AS MANUFACTURED IN AP GELEEN, THE NETHERLANDS. A II II 7/6/2005 7/12/2005 MALLINCKRODT INC SCINOPHARM TAIWAN LTD COMPAP(R) COURSE L (ESUB) AS MANUFACTURED IN GREENVILLE, IL. III 7/11/2005 II 7/11/2005 A A I A A A II II II II II II II 7/12/2005 7/12/2005 7/11/2005 7/1/2005 7/12/2005 7/12/2005 7/11/2005 II 7/6/2005 A A II II II 7/12/2005 7/7/2005 7/5/2005 A II II 7/7/2005 7/11/2005 BIOCON LTD CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD MYLAN LABORATORIES LTD HETERO LABS LTD A A I A A III II II III III III 7/5/2005 7/7/2005 7/8/2005 7/7/2005 7/5/2005 7/8/2005 KHEMKA GLASS PRODUCTS PVT LTD HETERO LABS LTD SANDOZ INDUSTRIAL PRODUCTS SA PACIFIC VIAL MANUFACTURING INC RICON COLORS STYROLUTION AMERICA LLC IV 6/22/2005 TAKASAGO INTERNATIONAL CORP STATUS Type SUBMIT DATE III 7/5/2005 HOLDER KHEMKA GLASS PRODUCTS PVT LTD SUBJECT

4Q2012

GLASS CYLINDERS, DENTAL LOCAL ANESTHETICS CARTRIDGES AND PEN INJECTOR CARTRIDGES AS MANUFACTURED IN GUJARAT, INDIA. TAK-051367 INTENSATES(R) NATURAL & ARTIFICIAL PEPPERMINT MASK (859) AS MANUFACTURED IN TETERBORO, NJ. NEUTRAL GLASS VIALS AS MANUFACTURED IN GUJARAT, INDIA. ZONISAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. GABAPENTIN (NON-STERILE BULK) AS MANUFACTURED IN BARCELONA, SPAIN. GLASS VIALS AS MANUFACTURED IN COMMERCE, CA. WHITE, CPP-W1528-1 AS MANUFACTURED IN WEST CHICAGO, IL. GENERAL PURPOSE POLYSTYRENE (GPPS) AND HIGH IMPACT POLYSTYRENE (HIPS) AS MANUFACTURED IN CHANNAHON, IL. FLUVASTATIN SODIUM AMORPHOUS AS MANUFACTURED IN BANGALORE, INDIA. MYCOPHENOLATE MOFETIL AS MANUFACTURED IN TAIPEI HSIEN, TAIWAN R.O.C. INDINAVIR SULFATE USP AS MANUFACTURE IN ANDHRA PRADESH, INDIA BICALUTAMIDE (FORM-H1), AS MANUFACTURED IN ANDHRA PRADESH, INDIA

ZHEJIANG HISUN PHARMACEUTICAL CO LTD VANCOMYCIN HYDROCHLORIDE USP (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN ZHEJIANG, CHINA. ZHEJIANG HISUN PHARMACEUTICAL CO LTD EPIRUBICIN HYDROCHLORIDE (LYOPHILIZED) NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN ZHEJIANG, CHINA. MYLAN LABORATORIES LTD CARVEDILOL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA MYLAN LABORATORIES LTD CADILA HEALTHCARE LTD MERCK KGAA MYLAN LABORATORIES LTD SUN PHARMACEUTICAL INDUSTRIES LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD REXAM HEALTHCARE LA VERPILLIERE NELFINAVIR MESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA OMEPRAZOLE AS MANUFACTURED IN GUJARAT, INDIA. CALCIUM CHLORIDE DIHYDRATE AS MANUFACTURED IN LEHRTE, GERMANY. AMLODIPINE BESILATE USP (AYP) AS MANUFACTURED IN ANDHRA PRADESH, INDIA OXCARBAZEPINE AS MANUFACTURED IN GUJARAT, INDIA CEFPODOXIME PROXETIL USP (NON-STERILE BULK) AS MANUFACTURED IN KANCHEEPURAM, INDIA. TAZOBACTAM ACID USP AS MANUFACTURED IN MAHARASHTRA, INDIA. METERED DOSE INHALER ACTUATORS AS MANUFACTURED IN LA VERPILLIERE, FRANCE.

EFLORNITHINE HYDROCHLORIDE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN R.O.C. FELODIPINE AS MANUFACTURED IN TURKU, FINLAND. RUBBER STOPPERS AS MANUFACTURED IN ITAPECERICA DA SERRA, BRAZIL. GLASS VIALS AS MANUFACTURED IN VARZEA, BRAZIL. GLASS VIALS AS MANUFACTURED IN SAO PAULO, BRAZIL.

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4Q2012EXCEL DMF# 18518 18519 A 18520 18521 18522 18523 18524 18525 18526 A 18527 18528 A 18529 18530 18531 I 18532 18533 A 18534 I 18535 I 18536 18537 18538 A 18539 A 18540 I 18541 A 18542 A 18543 18544 A 18545 18546 18547 A A A II II III 7/20/2005 7/20/2005 7/26/2005 A III II 8/1/2005 7/29/2005 ANADOLU CAM SANAYII AS HELSINN CHEMICALS SA HELSINN ADVANCED SYNTHESIS SA FIDIA FARMACEUTICI SPA FIDIA FARMACEUTICI SPA REXAM PHARMA PACKAGING INDIA P LTD IV 7/12/2005 WINCOAT COLOURS COATINGS PVT LTD II 7/29/2005 II 7/20/2005 II 7/20/2005 LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LTD GUANGDONG NEW NORTH RIVER PHARMACEUTICAL CO LTD NAVINTA LLC A A III III III 5/13/2005 5/13/2005 7/26/2005 IV 7/19/2005 IV 7/19/2005 I II II 7/20/2005 7/22/2005 FRESENIUS KABI ONCOLOGY LTD A A II II III 7/14/2005 7/15/2005 7/22/2005 ACIDCHEM INTERNATIONAL SDN BHD AUROBINDO PHARMA LTD INTRAPAC GROUP A II III 7/18/2005 7/19/2005 TAKASAGO INTERNATIONAL CORP REXAM HEALTHCARE OFFRANVILLE SAS A A A I A A II II II II II II IV 7/15/2005 6/30/2005 7/18/2005 7/17/2005 7/19/2005 11/8/2005 7/20/2005 FARMHISPANIA SA FABBRICA ITALIANA SINTETICI SPA ARTEMIS BIOTECH DIVIS LABORATORIES LTD CADILA HEALTHCARE LTD PARABOLIC DRUGS LTD SYMRISE INC STATUS Type SUBMIT DATE A II IV 6/30/2005 7/15/2005 HOLDER JOHNSON MATTHEY FINLAND LTD IPC PROCESS CENTER GMBH AND CO KG SUBJECT SMOPEX-234 AS MANUFACTURED IN TURKU, FINLAND.

4Q2012

CELLETS(R) (CELLULOSE MICROCRYSTALLINE, PELLETIZED) AS MANUFACTURED IN DRESDEN, GERMANY. FH-113 (RAMIPRIL) AS MANUFACTURED IN BARCELONA, SPAIN. OXCARBAZEPINE AS MANUFACTURED IN VICENZA, ITALY. SIMVASTATIN USP AS MANUFACTURED IN HYDERABAD, INDIA. VERAPAMIL HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. FAMOTIDINE AS MANUFACTURED IN GUJARAT, INDIA. 6-AMINOPENICILLANIC ACID (6-APA) AS MANUFACTURED IN HARYANA, INDIA. 826130 ENTRAPPED NATURAL & ARTIFICIAL CHERRY TYPE FLAVOR AS MANUFACTURED IN BRANCHBURG, NJ. D-THREO-RITALINIC ACID AS MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN. BOTTLE AND PISTON FOR DERMATOLOGICAL DISPENSER AS MANUFACTURED IN OFFRANVILLE, FRANCE. ISOPROPYL PALMITATE AS MANUFACTURED IN PENAN, MALAYSIA. CEFUROXIME SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA. INJECTION MOLDED PLASTIC PRODUCTS AS MANUFACTURED IN SAN JOSE, COSTA RICA. DISODIUM PAMIDRONATE AS MANUFACTURED IN WEST BENGAL, INDIA.

UNION QUIMICO FARMACEUTICA SA UQUIFA CLINDAMYCIN PHOSPHATE USP (AR) AS MANUFACTURED IN MILAN, ITALY. SA FONA INTERNATIONAL INC 929.042 N-C NATURAL & ARTIFICIAL WATERMELON FLAVOR AS MANUFACTURED IN CAROL STREAM, IL. FONA INTERNATIONAL INC 852.154 N-C NATURAL & ARTIFICIAL FRUIT PUNCH FLAVOR AS MANUFACTURED IN CAROL STREAM, IL. ESS DEE ALUMINIUM LTD ALUMINUM FOIL (BLISTER PACK) AS MANUFACTURED IN WEST BENGAL, INDIA. ESS DEE ALUMINIUM LTD DYNEON GMBH & CO KG ALUMINUM FOIL (STRIP PACK) AS MANUFACTURED IN WEST BENGAL, INDIA. PFA POLYMER DISPERSIONS AS MANUFACTURED IN BURGKIRCHEN, FEDERAL REPUBLIC OF GERMANY. LOVASTATIN (NON-STERILE, BULK FORM) AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA. MEVASTATIN (NON-STERILE, BULK FORM) AS MANUFACTURED IN GUANGDON PROVINCE, CHINA. SODIUM FERRIC GLUCONATE COMPLEX AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR NAVINTA LLC WINCOAT/SELECOAT (COATING MATERIAL) AS MANUFACTURED IN MAHARASHTRA, INDIA. PHARMACEUTICAL GLASS CONTAINERS AS MANUFACTURED IN ISTANBUL, TURKEY. TROSPIUM CHLORIDE AS MANUFACTURED IN BIASCA, SWITZERLAND. NIZATIDINE AS MANUFACTURED IN MULAZZANO (LO) ITALY SPIRONOLACTONE AS MANUFACTURED IN MULAZZANO (LO) ITALY TAMP LOCK / DOUBLE SAFE (R) PLASTIC CONTAINER CLOSURE SYSTEM AS MANUFACTURED IN KARNATAKA, INDIA

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4Q2012EXCEL DMF# 18548 A 18549 18550 18551 18552 I 18553 A 18554 A 18555 A 18556 18557 18558 A 18559 A 18560 18561 18562 A 18563 A 18564 18565 18566 18567 18568 18569 A 18570 I 18571 18572 I 18573 I 18574 A 18575 I 18576 A II 7/30/2005 AUROBINDO PHARMA LTD III 8/10/2005 ARKEMA INC IV 8/5/2005 II 5/7/2005 I II II 8/8/2005 5/7/2005 DAINIPPON SUMITOMO PHARMA CO LTD CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO LTD CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO LTD AEGIS THERAPEUTICS LLC III 7/29/2005 AMPACET CORP A A A A I II II II III III III 7/30/2005 8/1/2005 8/4/2005 8/3/2005 7/27/2005 8/3/2005 IND SWIFT LABORATORIES LTD LONZA BRAINE SA TRIFARMA SPA EMS CHEMIE NORTH AMERICA INC LONSTROFF AG PRESSPART GMBH CO KG II 11/11/2005 IPCA LABORATORIES LTD A A III II II 8/3/2005 8/5/2005 7/29/2005 POLYONE CORP PEPTISYNTHA SA FIDIA FARMACEUTICI SPA II 8/3/2005 RANBAXY LABORATORIES LTD A A II II II 8/1/2005 8/2/2005 7/25/2005 NV ORGANON SANDOZ GMBH AUROBINDO PHARMA LTD III 7/19/2005 II 7/25/2005 ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD COPE ALLMAN JAYCARE LTD III 7/26/2005 AMCOR FLEXIBLES BURGDORF GMBH A I I IV III II III 7/25/2005 8/1/2005 7/28/2005 7/26/2005 KERRY CANADA INC COLORS FOR PLASTICS INC CRYSTAL PHARMA SA AMCOR FLEXIBLES BURGDORF GMBH STATUS Type SUBMIT DATE III 7/26/2005 HOLDER REXAM PHARMA PACKAGING INDIA P LTD SUBJECT

4Q2012

PLASTIC CONTAINER & CLOSURES FOR ORAL PREPARATION AS MANUFACTURED IN BANGALORE, INDIA GRAPE NAT/ART FLAVOR MC006357 AS MANUFACTURED IN GRANBY, CANADA W07071-XRF AS MANUFACTURED IN ELK GROVE VILLAGE, IL FINASTERIDE AS MANUFACTURED IN BOECILLO (VALLADOLID), SPAIN COMPOUND PACKAGING MATERIAL (LAMINATE) PETP 12/ALU 12/LDPE 40 (SOP 51810) AS MANUFACTURED IN BURGDORF, SWITZERLAND. COMPOUND PACKAGING MATERIAL (LAMINATE) PETP 12/ALU 12/LDPE50 (SOP 51811) AS MANUFACTURED IN BURGDORF, SWITZERLAND. NAPROXEN USP (BULK) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. 150ML PET ROUND PACKER AS MANUFACTURED IN NEWCASTLE UPON TYNE, UNITED KINGDOM. ESTERIFIED ESTROGENS TYPE AC AS MANUFACTURED IN OSS, THE NETHERLANDS. HEPARIN SODIUM AS MANUFACTURED IN TYROL, AUSTRIA. CIPROFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ESOMEPRAZOLE MAGNESIUM (AMORPHOUS, NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN PUNJAB, INDIA. CC10042164WE AS MANUFACTURED IN GLENDALE, AZ. LARAZOTIDE AS MANUFACTURED IN BRUSSELS, BELGIUM. MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN GARBAGNATE MILANESE, ITALY. HYDROCHLOROTHIAZIDE USP, API PROCESS II (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA. ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN PUNJAB, INDIA EPTIFIBATIDE AS MANUFACTURED IN BRAINE-L'ALLEUD, BELGIUM HALOBETASOL PROPIONATE AS MANUFACTURED IN CERIANO LAGHETTO (MI) ITALY GRILAMID TR 55 NATURAL AS MANUFACTURED IN DOMAT/EMS, SWITZERLAND E5218C GREY AS MANUFACTURED IN AARAU, SWITZERLAND ALUMINUM ALLOY METERED DOSE INHALER CONTAINERS (ANODIZED AND INTERNALLY COATED) AS MANUFACTURED IN MARSBERG, GERMANY 102286 CLARITY SLIP AB POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN SMP-114 AS MANUFACTURED IN FUKUI, JAPAN PSEUDOEPHEDRINE SULFATE USP AS MANUFACTURED IN INNNER MONGOLIA, CHINA BALSALAZIDE DISODIUM DIHYDRATE AS MANUFACTURED IN MONGOLIA, CHINA INTRAVAIL(TM) A-5 (TETRADECYLMALTOSIDE) AS MANUFACTURED IN SAN LUIS OBISPO, CA & PISTOIA, ITALY. PLEXIGLAS(R) HF110-101, PLEXIGLAS(R) HF110G-101 AND PLEXIGLAS(R) VS-100 AS MANUFACTURED IN BRISTOL, PA AND LOUISVILLE, KY. NEVIRAPINE ANHYDROUS USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

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4Q2012EXCEL DMF# 18577 I 18578 I 18579 I 18580 I 18581 A 18582 18583 18584 18585 A 18586 I 18587 18588 18589 18590 18591 I 18592 18593 I 18594 A 18595 18596 18597 18598 18599 18600 18601 18602 18603 I 18604 18605 18606 I 18607 I II 12/13/1991 GOODWIN BIOTECHNOLOGY INC I I II II 7/3/1991 8/1/1991 BEN VENUE LABORATORIES INC MILLIPORE CORP MEDAREX INC DURAPORE FILTER MEMBRANE I A I I I I I I II II 9/28/1989 11/2/1989 II II V II II II 8/22/1988 2/13/1985 4/25/1986 3/21/1988 7/14/1988 4/28/1989 PROGEN INDUSTRIES LTD LONZA BIOLOGICS PLC SANOFI WINTHROP INC BIOLOGICAL THERAPY INSTITUTE BIOLOGICAL THERAPY INSTITUTE IMMUNOMEDICS INC NEORX CORP BIOINVENT PRODUCTION AB IMMUNOMEDICS INC MONOCLONAL ANTIBODY PRODUCTION II 3/19/1985 CENTOCOR INC EDRECOLOMAB [MURINE MONOCLONAL ANTIBODY (17-1A) TO COLORECTAL CARCINOMA] MONOCLONAL ANTIBODIES IMMOBILIZED MONOCLONAL ANTIBODY (NK2) TO INTERFERON MANUFACTURING FACILITY - INTERFERON MURINE MONOCLONAL ANTIBODIES MITOMYCIN-C CONJUGATED MURINE MONOCLONAL ANTIBODIES MURINE MONOCLONAL ANTIBODY (IMMU-31) TO ALPHA-FETOPROTEIN A II II 4/15/1988 9/22/1987 YU ALICE L MD PHD CENTOCOR INC I N I I II 3/16/1989 II 5/28/1991 BERKELEY ANTIBODY CO NOT AN ASSIGNED NUMBER IMMUNOMEDICS INC NEORX CORPORATION YU ALICE L MD PHD II 5/24/1991 CENTOCOR INC I A I III III II II 8/11/2005 8/11/2005 8/15/2005 8/15/2005 II 6/24/2005 II 8/11/2005 II 8/8/2005 II 4/29/2005 STATUS Type SUBMIT DATE II 6/6/2005 HOLDER SHIJIAZHUANG PHARMACEUTICAL GROUP OUYI PHARMA CO LTD SHIJIAZHUANG PHARMACEUTICAL GROUP HUASHENG PHARMA CO LTD GUANGZHOU HUANYE PHARMACEUTICAL CO LTD GUANGDONG NEW NORTH RIVER PHARMACEUTICAL CO LTD SOUTHWEST SYNTHETIC PHARMACEUTICAL CO LTD AMERICHEM INC AMERICHEM INC INCELL CORP LLC INCELL CORP LLC SUBJECT ALENDRONATE SODIUM USP 28 AS MANUFACTURED IN HEBEI, CHINA. TRAMADOL HYDROCHLORIDE EP AS MANUFACTURED IN HEBEI, CHINA.

4Q2012

VINCRISTINE SULFATE USP (NON-STERILE BULK DRUG) AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA. PRAVASTATIN SODIUM AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA. NABUMETONE USP AS MANUFACTURED IN CHONGQING, CHINA. 46603-CD1 RED AS MANUFACTURED IN CUYAHOGA FALLS, OH. 46603-CD2 RED AS MANUFACTURED IN CUYAHOGA FALLS, OH ACE(TM) CELL CULTURE MEDIUM AS MANUFACTURED IN SAN ANTONIO, TX. EZ-CPZ(TM) AND EZ-CPZ-H(TM) CELL CRYOPRESERVATION MEDIA AS MANUFACTURED IN SAN ANTONIO, TX. HUMAN-MURINE CHIMERIC MONOCLONAL ANTIBODY TO TUMOR NECROSIS FACTOR FOR SEPSIS (CENTOCOR) MURINE MONOCLONAL ANTIBODY PRODUCTION (ASCITES)

CHIMERIC (HUMAN/MURINE) MONOCLONAL ANTIBODY (14.18) TO GD2 ANTIGEN (NEUROBLASTOMA) MURINE MONOCLONAL ANTIBODY (14G2A) TO GD2 99M-TC-MURINE MONOCLONAL ANTIBODY (FAB') (T2G1S) TO HUMAN FIBRIN II (B-CHAIN)

MURINE MONOCLONAL ANTIBODY (IMM-LL-2) TO B-CELL LYMPHOMA AND LEUKEMIA CELLS

MURINE MONOCLONAL ANTIBODY (PM-81) TO HUMAN MYELOID DIFFERENTIATION ANTIGEN PRODUCTION OF MONOCLONAL ANTIBODIES

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4Q2012EXCEL DMF# 18608 I 18609 I 18610 18611 18612 18613 I 18614 18615 I 18616 18617 A 18618 18619 I 18620 18621 I 18622 18623 18624 18625 18626 18627 I 18628 18629 18630 A 18631 18632 18633 I 18634 18635 18636 18637 I 18638 I II 4/4/1995 I I I II V II 2/21/1995 2/24/1995 2/23/1995 NEORX CORP CEL SCI CORP CHIRON BETA CORP BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG BIOTRANSPLANT INC LEUKOCYTE INTERLEUKIN, INJECTION CHIRON BETA CORPORATION, CANOVANAS PUERTO RICO INTERLEUKIN-12 BULK SUBSTANCE RAT MONOCLONAL ANTIBODY (BTI-322) TO CD2+ T CELLS AND NK CELLS (BIOTRANSPLANT) OR MUROMONAB-CD3 (OKT3, ORTHO) EACH WITH IMMUNOSUPPRESSIVE AGENTS A I II II II 10/9/1978 8/9/1994 9/16/1994 ADVANCE BIOFACTURES CORP SCANTIBODIES LABS INC GLAXOSMITHKLINE I I V II II 4/5/1994 5/1/1990 4/6/1994 ELAN DRUG DELIVERY INC DRAXIMAGE INC KREITMAN ROBERT J MD I I I I A II II 2/1/1994 3/16/1994 II 12/31/1991 GENENTECH INC NEORX CORP SEPRACOR INC NEORX CORP HYCLONE LABS INC DOW CHEMICAL CO HYQ-CCM1 WITH AND WITHOUT PHENOL RED MEMBRANE AFFINITY PURIFIER FOR ANTIBODIES AND OTHER BIOLOGICALS I II II 5/23/1988 11/12/1993 I II II 6/29/1993 10/8/1993 A II II 1/17/1989 4/1/1993 A II II 10/22/1992 3/22/1993 HEMISPHERX BIOPHARMA INC NATIONAL INSTITUTES HEALTH NATIONAL CANCER INSTITUTE HOECHST MARION ROUSSEL BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG PIERCE CHEMICAL CO SERAGEN INC SUB LIGAND PHARMACEUTICALS INC SYNTEX (USA) INC ENZON INC I I I II II II II 8/14/1992 8/13/1992 6/25/1990 7/13/1990 EISAI INC MILLIPORE CORP DOW CHEMICAL CO GENETICS AND IVF INSTITUTE II 6/30/1992 INSTITUTE MOLECULAR BIOLOGY INC STATUS Type SUBMIT DATE II 6/30/1992 HOLDER INSTITUTE MOLECULAR BIOLOGY INC SUBJECT

4Q2012

INSULIN-LIKE GROWTH FACTOR-I (HUMAN, RECOMBINANT, YEAST, INSTITUTE OF MOLECULAR BIOLOGY) PLATELET DERIVED GROWTH FACTOR-BB (HUMAN, RECOMBINANT, C-127 MOUSE MAMMARY CELLS, INSTITUTE OF MOLECULAR BIOLOGY) INTERLEUKIN-2 DIPHTHERIA TOXIN FUSION PROTEIN (DAB 389 IL-2) VIRAL FILTER MEMBRANES (MILLIPORE) MURINE MONOCLONAL ANTIBODY (COL-1) TO CEA MF-MODIFIED TISSUE PLASMINOGEN ACTIVATOR, FEIX, (DEL 6-86, ASP-GLU117) (RECOMBINANT, HUMAN, CHO CELLS) INTERFERON ALFA-N3 GEL (HUMAN LEUKOCYTE, INTERFERON SCIENCES) PSEUDOMONAS EXOTOXIN (RECOMBINANT, NLYSPE38) CONJUGATED MURINE MAB (B3) TO B3 ANTIGEN AND RITUXIMAB [CHIMERIC MOAB (C2B8) (IDEC) TO CD20] MURINE MONOCLONAL ANTIBODY BMA-031 TO T CELL RECEPTOR NR-LU-10 MURINE MONOCLONAL ANTIBODY FAB FRAGMENT (NOFETUMOMAB) AND PHENTHIOATE LIGAND BULK MATERIAL FOR ONCOTRAC KIT (NEORX) HYDRATED AZLACTONE FUNCTIONAL BEADS AS BIOSUPPORT MEDIUM EPIDERMAL GROWTH FACTOR DIPHTHERIA TOXIN FUSION PROTEIN (DAB389EGF) INTERLEUKIN-1 BETA (RECOMBINANT, E. COLI) (IMMUNEX) BULK SINGLE CHAIN FV MONOCLONAL ANTIBODY (CC49) (MURINE, RECOMBINANT, E.COLI) TO TAG-72

CHIMERIC (MURINE VARIABLE, HUMAN CONSTANT) MONOCLONAL ANTIBODY (CC49) TO TUMOR ASSOCIATED GLYCOPROTEIN (TAG)-72 TREHALOSE STANNOUS GLUCONATE COMPLEX INTERLEUKIN-6 PSEUDOMONAS EXOTOXIN FUSION PROTEIN (HUMAN, RECOMBINANT, E. COLI) COLLAGENASE (C. HISTOLYTICUM, ADVANCE BIOFACTURES) REAGENTS FOR HUMAN ANTI-MOUSE ANTIBODY (HAMA) TESTING CHIMERIC (MACAQUE VARIABLE/HUMAN CONSTANT) (RECOMBINANT, CHO CELLS) MONOCLONAL ANTIBODY (SB 210396; CE9.1) TO HUMAN CD4 ANTIGEN

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4Q2012EXCEL DMF# 18639 18640 18641 A 18642 I 18643 18644 I 18645 18646 18647 A 18648 18649 18650 18651 A 18652 18653 18654 18655 A 18656 18657 18658 18659 I 18660 18661 18662 18663 18664 I 18665 18666 18667 I 18668 18669 18670 A 18671 A II 3/13/2001 MEDIMMUNE LLC A A II II II 9/18/2000 10/18/2000 1/31/2001 FRED HUTCHINSON CANCER RESCTR MDS NORDION MILLIPORE CORP MURINE MONOCLONAL ANTIBODY (BC8) TO CD45 YTTRIUM-Y-90 CHLORIDE (FISSION) I A V II II 12/28/1999 6/29/2000 9/20/2000 CANCER AND LEUKEMIA GROUP B MDS NORDION BIOGEN IDEC INC I I I I II II V 10/6/1999 11/9/1999 1/13/2000 II 6/4/1999 ABGENIX INC LONZA BIOLOGICS PLC MEDAREX INC GENENTECH INC GENETICS INSTITUTE INC MURINE MONOCLONAL ANTIBODY (ALPHA CTLA4) TOCTLA4 DORNASE ALFA INHALATION SOLUTION (GENENTECH) I I A II II 4/9/1999 5/15/1999 NEORX CORP PROTEIN DESIGN LABS INC HYCLONE LABS INC ABGENIX INC HYQ-PF CHO SERUM-FREE MEDIUM A A I II V II II 4/15/1998 12/2/1997 5/7/1998 8/20/1998 I I I II 3/24/1998 MEDAREX INC ABGENIX INC NEORX CORP I A II II II 12/23/1996 2/26/1997 3/27/1997 MEDIMMUNE INC BIOGEN IDEC INC MEDIMMUNE INC I II II 10/11/1996 11/26/1996 NEKTAR AL KYOWA HAKKO KOGYO CO LTD II 9/19/1996 VISTA BIOLOGICALS CORP STATUS Type SUBMIT DATE A A II II II 4/11/1995 8/21/1995 8/31/1996 HOLDER ADVANCE BIOFACTURES CORP GENENTECH INC LONZA BIOLOGICS PLC SUBJECT COLLAGENASE INJECTABLE THROMBOPOIETIN (HUMAN, RECOMBINANT, CHO CELLS, GENENTECH)

4Q2012

BULK PURIFIED HUMANIZED MONOCLONAL ANTIBODY (AN100226)(NSO CELLS, LONZA) TO ALPHA 4 INTEGRIN MURINE MONOCLONAL ANTIBODIES TO HUMAN LEUCOCYTE FUNCTION ANTIGEN-1 (LFA1) PEG-2 REAGENT AND MSPA20K PEGYLATED GRANULOCYTE COLONY-STIMULATING FACTOR MUTEIN BULK SUBSTANCE HUMANIZED MONOCLONAL ANTIBODY (HULM609) TO HUMAN VITRONECTIN RECEPTOR MURINE MONOCLONAL ANTIBODY (2B8) TO CD20 SIPLIZUMAB [HUMANIZED MONOCLONAL ANTIBODY (MEDI-507) (NSO CELLS, MEDIMMUNE) TO CD2]

SMITHKLINE BEECHAM PHARMACEUTICALS CLENOLIXIMAB [CHIMERIC (MACAQUE/HUMAN) MONOCLONAL ANTIBODY (SB-217969) (CHO CELLS, SMITHKLINE BEECHAM) TO CD4] TENX BIOPHARMA HUMAN MONOCLONAL ANTIBODY TO CD4 (ZANOLIMUNAB) UNIV BRITISH COLUMBIA DIAMYD THERAPEUTICS AB BIOGEN IDEC INC MS/MRI RESEARCH GROUP AT THE UNIVERSITY OF BRITISH COLUMBIA RECOMBINANT HUMAN GLUTAMIC ACID DECARBOXYLASE (RHGAD65) IDEC-114 (GALIXIMAB);CHEMERIC (MACAQUE/HUMAN) MONOCLONAL ANTIBODY TO CD80 (B7.1)

HUMAN MONOCLONAL ANTIBODY (ABX-EGF) TO EPIDERMAL GROWTH FACTOR RECEPTOR BULK PURIFIED MURINE MONOCLONAL ANTIBODY (ABX-CBL) TO BLAST CELLS

GENETICS INSTITUTE, INCORPORATED, ANDOVER, MASSACHUSETTS CLINICAL FILL/FINISH FACILITY CANCER AND LEUKEMIA GROUP B (CALGB) YTTRIUM - Y - 90 CHLORIDE STERILE SOLUTION HUMANIZED MONOCLONAL ANTIBODY (IDEC-131) (CHO CELLS, IDEC) TO CD40L (CD 154)

RETROPORE MEMBRANE AND VIRESOLVE NORMAL FLOW RETROVIRUS FILTER DEVICE (MILLIPORE) HUMANIZED MONOCLONAL ANTIBODY (MEDI-522) TO THE VITRONECTIN (ALPHA-5 BETA3) RECEPTOR Page 555

4Q2012EXCEL DMF# 18672 18673 I 18674 A 18675 18676 18677 18678 18679 18680 A 18681 A 18682 I 18683 18684 18685 18686 18687 18688 18689 18690 A 18691 18692 A 18693 I 18694 A 18695 A 18696 18697 A 18698 18699 18700 18701 A 18702 A II 8/25/2005 CADILA HEALTHCARE LTD A I A IV II II II 8/24/2005 8/24/2005 8/25/2005 8/25/2005 A II II 8/23/2005 8/24/2005 III 8/15/2005 III 8/15/2005 III 8/15/2005 A II II 8/18/2005 8/19/2005 A I A I A A A II II II II II II 10/15/2003 3/15/2004 8/5/2005 8/5/2005 8/5/2005 8/18/2005 II 9/15/2003 FRED HUTCHINSON CANCER RESCTR MEDAREX INC MDS NORDION ELI LILLY AND CO RIOCARE INDIA PVT LTD RIOCARE INDIA PVT LTD RIOCARE INDIA PVT LTD YTTRIUM (Y-90) CHLORIDE (FISSION) MDX-068 (HUMANIZED ANTI-B-AMYLOID MONOCLONAL ANTIBODY) (ESUB) SIMETHICONE USP AS MANUFACTURED IN MAHARASHTRA, INDIA. DIMETHICONE USP AS MANUFACTURED IN MAHARASHTRA, INDIA. SIMETHICONE EMULSION USP AS MANUFACTURED IN MAHARASHTRA, INDIA. II 6/24/2003 MEDAREX INC II 12/9/2002 MEDAREX INC I I I I I II II II II II II 12/20/2001 2/25/2002 2/28/2002 10/4/2000 4/17/2002 9/6/2002 FRED HUTCHINSON CANCER RESCTR CHEMICON INTERNATIONAL VIRON THERAPEUTICS VIVENTIA BIOTECH INC BRISTOL MYERS SQUIBB CO WYETH PHARMACEUTICALS INC II 8/6/2001 NEKTAR AL STATUS Type SUBMIT DATE I II II 4/2/2001 4/30/2001 HOLDER AMGEN INC LONZA BIOLOGICS PLC SUBJECT

4Q2012

HUMAN MONOCLONAL ANTIBODY (MDX-015)(SP2/0,- AG14 CELLS, MEDAREX) TO IL15 BULK PURIFIED HUMANIZED MONOCLONAL ANTIBODY (H5G1-1)(NSO CELLS. LONZA) TO C5 METHOXYPOLY (ETHYLENE GLYCOL)- SUCCINIMIDYL(ESUB) BUTANOATE, MW 30,000 (MSBA30K) HUMAN MONOCLONAL ANTIBODY (ABX-MA1) TO MUC-18 MURINE MONOCLONAL ANTIBODY (T10B9-1A31) TO T CELLS SERINE PROTEINASE INHIBITOR-1 (CHO CELLS, BIOVEST INTERNATIONAL) GELONIN, RECOMBINANT (E. COLI) HUMAN MONOCLONAL ANTIBODY (MDX-060) TO CD30 BONE MORPHOGENETIC PROTEIN-2 (HUMAN, RECOMBINANT, CHO CELLS, WYETH) AS (ESUB) HUMAN MONOCLONAL ANTIBODY (MDX-070) TO PROSTATE SPECIFIC MEMBRANE ANTIGEN HUMAN MONOCLONAL ANTIBODY (MDX-214) TO THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) MURINE MONOCLONAL ANTIBODY (9.3) TO CD-28

ZHEJIANG HISUN PHARMACEUTICAL CO LTD FAMCICLOVIR (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. DELMAR CHEMICALS LTD (R)-BAP L-MA AS MANUFACTURED IN QUEBEC, CANADA. ZHEJIANG HISUN PHARMACEUTICAL CO LTD LOSARTAN POTASSIUM (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. ADHESIVES RESEARCH INC MA-24B ADHESIVE AS MANUFACTURED BY ADHESIVES RESEARCH INC AND ADHESIVES RESEARCH IRELAND LTD IN GLEN ROCK, PA AND LIMERICK, IRELAND. ADHESIVES RESEARCH INC HY-9 ADHESIVE AS MANUFACTURED BY ADHESIVES RESEARCH INC IN GLEN ROCK, PA AND ADHESIVES RESEARCH IRELAND LTD IN LIMERICK, IRELAND. ADHESIVES RESEARCH INC HY-10 ADHESIVE AS MANUFACTURED BY ADHESIVES RESEARCH INC IN GLEN ROCK, PA AND ADHESIVES RESEARCH IRELAND LTD IN LIMERICK, IRELAND. CATALENT PHARMA SOLUTIONS LLC LORATADINE SOFTGELS (10 MG) AS MANUFACTURED IN ST. PETERSBURG, FL. SHANDONG LUNAN BETTER PHARMACEUTICAL CO LTD GATTEFOSSE SA DOCTOR REDDYS LABORATORIES LTD CADILA HEALTHCARE LTD CIPLA LTD ZOLPIDEM TARTRATE (NON-STERILE BULK FORM) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA. PANCOGENE(R) MARIN AS MANUFACTURED IN PERSAN, FRANCE. DISODIUM PAMIDRONATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. TOPIRAMATE AS MANUFACTURED IN GUJARAT, INDIA. PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. LORATADINE AS MANUFACTURED IN GUJARAT, INDIA.

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4Q2012EXCEL DMF# 18703 18704 18705 18706 18707 18708 18709 I 18710 A 18711 A 18712 18713 18714 18715 18716 A 18717 18718 18719 18720 18721 I 18722 18723 18724 A 18725 A 18726 A 18727 18728 I 18729 I 18730 18731 A 18732 18733 18734 18735 A A A I II II II IV 9/9/2005 9/7/2005 9/9/2005 8/12/2005 ALEMBIC PHARMACEUTICALS LTD HETERO LABS LTD ALEMBIC PHARMACEUTICALS LTD SUNIL HEALTHCARE LTD A IV II 9/6/2005 9/7/2005 III 9/7/2005 A II II 8/31/2005 9/2/2005 II 8/31/2005 II 9/2/2005 A A II II III 9/1/2005 8/31/2005 9/1/2005 FARMABIOS S P A CIPLA LTD APTAR FRANCE SAS A I A A II IV II III II 8/29/2005 8/31/2005 8/31/2005 8/31/2005 8/23/2005 I A A A III II II II II 8/25/2005 8/18/2005 8/18/2005 8/30/2005 8/29/2005 III 8/29/2005 II 8/25/2005 STATUS Type SUBMIT DATE A I A A A I II II II II II II II 9/29/2005 8/8/2005 8/8/2005 8/15/2005 8/16/2005 8/26/2005 8/24/2005 HOLDER BITOLEA SPA CHIMICA ECOLOGICA ACS DOBFAR SPA ACS DOBFAR SPA ERREGIERRE SPA ERREGIERRE SPA CATALENT PHARMA SOLUTIONS LLC SUBJECT KETOENAMINE AS MANUFACTURED IN LANDRIANO, ITALY. CLINDAMYCIN HYDROCHLORIDE AS MANUFACTURED IN BERGAMO, ITALY. CLINDAMYCIN PHOSPHATE AS MANUFACTURED IN BERGAMO, ITALY. ARIPIPRAZOLE AS MANUFACTURED IN BERGAMO, ITALY. BUTENAFINE HYDROCHLORIDE AS MANUFACTURED IN BERGAMO, ITALY. R115866 SOFTGELS AS MANUFACTURED IN SOMERSET, NJ.

4Q2012

ZHEJIANG HISUN PHARMACEUTICAL CO LTD PRAVASTATIN SODIUM (AMORPHOUS, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. ZHEJIANG HISUN PHARMACEUTICAL CO LTD TAZOBACTAM SODIUM (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. WACKER CHEMIE AG VINNAPAS(R) B 100 AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR WACKER POLYMER SYSTEMS LP CODING PRODUCTS TTR-51524 THERMAL TRANSFER INK RIBBON AS MANUFACTURED IN KALKASKA, MI. AUROBINDO PHARMA LTD AUROBINDO PHARMA LTD TORRENT PHARMACEUTICALS LTD TIANJIN TIANYAO PHARMACEUTICALS CO LTD SCINOPHARM TAIWAN LTD CARGILL POLYOLS LLC ALEMBIC PHARMACEUTICALS LTD NOVARTIS PHARMACEUTICALS CORP STRAINRITE LAMIVUDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ZIDOVUDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA. PREDNISOLONE USP BULK AS MANUFACTURED IN TIANJIN, CHINA. TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN TAINAN, TAIWAN R.O.C. ERYTHRITOL 16956 (PHARMA EXCIPIENT GRADE) AS MANUFACTURED IN BLAIR, NE. AZITHROMYCIN MONOHYDRATE USP AS MANUFACTURED IN GUJARAT, INDIA. T-326 DRY POWDER INHALER DEVICE AS MANUFACTURED IN SAN CARLOS, CA. DCX-8XX-MD-XX-XXX-XXX: 8-INCH NOMINAL DIAMETER CLARIFICATION VESSEL FOR ONETIME USE. CEFUROXIME SODIUM STERILE USP AS MANUFACTURED IN PAVIA, ITALY. BICALUTAMIDE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA.

QUALITY CONTROL METHODS FOR APTAR PACKAGING COMPONENTS AS MANUFACTURED IN LE VAUDREUIL, FRANCE AND CONGERS, NEW YORK NOVARTIS PHARMACEUTICALS CORP PULMOSPHERE(R) PLACEBO INHALATION POWDER AS MANUFACTURED IN SAN CARLOS, CA. EVONIK REXIM NANNING PHARMACEUTICAL L-METHIONINE (PHARMACEUTICAL INFUSION GRADE) AS MANUFACTURED IN GUANGXI, CO LTD CHINA. HIKMA PHARMACEUTICALS GLYCOPYRROLATE USP AS MANUFACTURED IN AMMAN, JORDAN. NATIONAL INSTITUTES HEALTH NATIONAL 2-CYANO-3, 12-DIOXOOLEANA-1, 9(11)-DIEN-28-OIC ACID (CDDO) AS MANUFACTURED BY CANCER INSTITUTE STARKS ASSOCIATES, INC IN BUFFALO, NY. KUNSTSTOFFWERK KREMSMUNSTER GMBH 71.216.32 DP1S1 PP 28 CAPS T/E CRC WITH SILICAGEL AS MANUFACTURED IN KREMSMUNSTER, AUSTRIA. DMV FONTERRA EXCIPIENTS GMBH CO KG RESPITOSE(R) ML003 AS MANUFACTURED IN VEGHEL, THE NETHERLANDS. RESOLUTION CHEMICALS LIMITED DRONABINOL USP AS MANUFACTURED IN SCOTLAND AND HERTFORDSHIRE, U.K. FOR RESOLUTION CHEMICALS LTD. LAMOTRIGINE AS MANUFACTURED IN GUJARAT, INDIA. DIDANOSINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. VENLAFAXINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA. EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN RAJASTHAN, INDIA. Page

557

4Q2012EXCEL DMF# 18736 18737 18738 A 18739 I 18740 A 18741 A 18742 18743 18744 A 18745 18746 18747 18748 18749 18750 18751 18752 A 18753 A 18754 A 18755 18756 18757 18758 18759 18760 18761 18762 18763 18764 18765 18766 18767 18768 18769 A A A I I N N A A A I I I I I II III III III III III III III 9/13/2005 9/1/2005 9/1/2005 9/8/2005 9/8/2005 9/8/2005 9/8/2005 9/8/2005 II II II II II 9/13/2005 9/12/2005 8/26/2005 9/12/2005 9/12/2005 JUBILANT LIFE SCIENCES LTD GLENMARK GENERICS LTD MOEHS IBERICA SL TEVA PHARMACEUTICAL INDUSTRIES LTD GLENMARK PHARMACEUTICALS LTD NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER BIOCON LTD POLYONE CORP POLYONE CORP AMPACET CORP AMPACET CORP AMPACET CORP AMPACET CORP AMPACET CORP FLUVASTATIN SODIUM AS MANUFACTURED IN BANGALORE, INDIA. CC10064753BG AS MANUFACTURED IN MANCHESTER, U.K. CC10069184BG AS MANUFACTURED IN MANCHESTER, U.K. AMPACET 191423-K GREY 423 AS MANUFACTURED IN RAYONG, THAILAND. AMPACET 140456-K ORANGE 456 AS MANUFACTURED IN RAYONG,THAILAND. AMPACET 181060-K BROWN 060 AS MANUFACTURED IN RAYONG, THAILAND. AMPACET 162057-K BLUE 057 AS MANUFACTURED IN RAYONG, THAILAND. AMPACET 191422-K BLACK 422 AS MANUFACTURED IN RAYONG, THAILAND. SIMVASTATIN USP AS MANUFACTURED IN KARNATAKA, INDIA. ADAPALENE AS MANUFACTURED IN GUJARAT, INDIA. TRIAMTERENE AS MANUFACTURED IN BARCELONA, SPAIN. TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN ZAGREB, CROATIA. TELMISARTAN AS MANUFACTURED IN GUJARAT, INDIA. IV 9/2/2005 DAVID MICHAEL AND CO INC IV 9/2/2005 DAVID MICHAEL AND CO INC A A I A A A A IV II IV IV IV IV IV IV 8/10/2005 9/8/2005 9/2/2005 9/2/2005 9/2/2005 9/2/2005 9/2/2005 9/2/2005 UNGERER AND CO QUIMICA SINTETICA SA DAVID MICHAEL AND CO INC DAVID MICHAEL AND CO INC DAVID MICHAEL AND CO INC DAVID MICHAEL AND CO INC DAVID MICHAEL AND CO INC DAVID MICHAEL AND CO INC A I II II III 9/9/2005 9/9/2005 9/2/2005 INFAR SA MITSUBISHI TANABE PHARMA CORP ELM PLASTIC GMBH IV 9/9/2005 NANOTHERAPEUTICS INC II 9/8/2005 BCN PEPTIDES II 9/9/2005 PROMETHEUS LABORATORIES INC STATUS Type SUBMIT DATE A A III III III 9/1/2005 9/1/2005 9/8/2005 HOLDER POLYONE CORP POLYONE CORP SABIC INNOVATIVE PLASTICS SUBJECT CC10037686BG AS MANUFACTURED IN MANCHESTER, UNITED KINGDOM. CC10037779BG AS MANUFACTURED IN MANCHESTER, UNITED KINGDOM.

4Q2012

CYCOLOY * RESINS AS MANUFACTURED BY IN CARTAGENA, SPAIN , MT VERNON, INDIANA (USA), AND SELKIRK, NEW YORK (USA) AZATHIOPRINE 50 MG TABLETS AND PLACEBO TABLETS AS MANUFACTURED IN DARTFORD, U.K. FOR PROMETHEUS LABORATORIES, INC. OCTREOTIDE ACETATE BULK ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN BARCELONA, SPAIN. GELSITE(R) POLYMER, A PHARMACEUTICAL EXCIPIENT FOR MUCOSAL DELIVERY APPLICATIONS. 5-AMINOSALICYLIC ACID I (MESALAMINE) AS MANUFACTURED IN BARCELONA, SPAIN. MP-513 DRUG SUBSTANCE AS MANUFACTURED IN IBARAKI, JAPAN. PLASTIC DOSING PIPETTES AND ACCESSORY AS MANUFACTURED IN DUDELDORF, GERMANY. NATURAL PEPPERMINT EXT. FN-2356 AS MANUFACTURED IN BETHLEHEM, PA. IRBESARTAN AS MANUFACTURED IN MADRID, SPAIN. ARTIFICIAL CREAM FLAVOR #20761 AS MANUFACTURED IN PHILADELPHIA, PA. ARTIFICIAL CREAM FLAVOR #12034 AS MANUFACTURED IN PHILADELPHIA, PA. ARTIFICIAL CREAM FLAVOR #20844 AS MANUFACTURED IN PHILADELPHIA, PA. ARTIFICIAL VANILLA FLAVOR #15448 AS MANUFACTURED IN PHILADELPHIA, PA. ARTIFICIAL VANILLA FLAVOR #1119 AS MANUFACTURED IN PHILADELPHIA, PA. ARTIFICIAL VANILLA CREAM FLAVOR #24549 AS MANUFACTURED IN PHILADELPHIA, PA. MICHAEL-THERMICS(R) ARTIFICIAL VANILLA FLAVOR #16618 AS MANUFACTURED IN PHILADELPHIA, PA. ARTIFICIAL VANILLA CREAM FLAVOR #20397 AS MANUFACTURED IN PHILADELPHIA, PA.

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4Q2012EXCEL DMF# 18770 A 18771 18772 18773 A 18774 18775 I 18776 I 18777 A 18778 I 18779 18780 I 18781 18782 18783 18784 A 18785 18786 18787 18788 A 18789 18790 A 18791 18792 18793 18794 18795 18796 18797 18798 I 18799 A 18800 A II 9/21/2005 II 9/20/2005 SHENZHEN ORIENTAL PHARMACEUTICAL CO LTD CIPLA LTD A A A A A A A II II II III IV IV II III 9/16/2005 9/19/2005 9/17/2005 8/30/2005 9/19/2005 9/19/2005 9/12/2005 9/21/2005 DELMAR CHEMICALS INC EXCELLA GMBH IND SWIFT LABORATORIES LTD ARIDIEN INC UNGERER AND CO UNGERER AND CO IND SWIFT LABORATORIES LTD FPC FLEXIBLE PACKAGING CORP A II III 9/19/2005 9/19/2005 A I C III II II II 9/12/2005 9/19/2005 9/19/2005 9/20/2005 AMERICAN RENOLIT CORP BOEHRINGER INGELHEIM CHEMICALS INC HETERO DRUGS LTD MALLADI DRUGS AND PHARMACEUTICALS LTD NEULAND LABORATORIES LTD NOLATO CERBO AB A A N IV 9/19/2005 II II 9/12/2005 9/19/2005 A II II 9/15/2005 8/22/2005 II 9/8/2005 SUZHOU NUMBER 4 PHARMACEUTICAL FACTORY MOEHS IBERICA SL ZHEJIANG TIANYU PHARMACEUTICAL CO LTD AUROBINDO PHARMA LTD WATSON PHARMA PRIVATE LTD NOT AN ASSIGNED NUMBER MANE INC II 9/14/2005 TORRENT PHARMACEUTICALS LTD II 9/15/2005 GEDEON RICHTER LTD A II II 9/13/2005 9/15/2005 CAMBREX CHARLES CITY INC LIGHT SCIENCES ONCOLOGY INC ARIPIPRAZOLE AS MANUFACTURED IN CHARLES CITY, IA. I I III III IV 9/8/2005 9/8/2005 9/12/2005 AMPACET CORP AMPACET CORP DAVID MICHAEL AND CO INC STATUS Type SUBMIT DATE III 9/8/2005 HOLDER AMPACET CORP SUBJECT AMPACET PRODUCT 7188175 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN AND CARTERSVILLE, GA. AMPACET 162058-K VIOLET 058 AS MANUFACTURED IN RAYONG, THAILAND. AMPACET 171463-K GREEN 463 AS MANUFACTURED IN RAYONG, THAILAND.

4Q2012

ARTIFICIAL VANILLA CREAM FLAVOR #27699 AS MANUFACTURED IN PHILADELPHIA, PA.

TALAPORFIN SODIUM (LS11) LYOPHILIZED DRUG PRODUCT AS MANUFACTURED IN BLOOMINGTON, IN FOR LIGHT SCIENCES CORP BICALUTAMIDE (MICRONIZED) AS MANUFACTURED IN DOROG AND BUDAPEST, HUNGARY. ROPINIROLE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN GUJARAT, INDIA. CLINDAMYCIN HYDROCHLORIDE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA. PANTOPRAZOLE SODIUM AS MANUFACTURED IN CANTABRIA, SPAIN. LOSARTAN POTASSIUM AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. BISOPROLOL FUMARATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. IMIQUIMOD AS MANUFACTURED IN MAHARASHTRA, INDIA. E_0405329 STRAWBERRY FLAVOR AS MANUFACTURED IN BAR SUR LOUP, FRANCE FOR MANE INC PVC FILMS AS MANUFACTURED IN LAPORTE, IN. LANTHANUM CARBONATE HYDRATE AS MANUFACTURED IN PETERSBURG, VA. AMLODIPINE BESILATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. PHENYLEPHRINE AND SALT AS MANUFACTURED IN TAMIL NADU, INDIA. MOXIFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. AB CERBO PHARMACEUTICAL CONTAINERS AND CLOSURES AS MANUFACTURED IN TROLLHATTAN, SWEDEN. FLUORESCEIN AS MANUFACTURED IN QUEBEC, CANADA. BICALUTAMIDE (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY. AT1 DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN PUNJAB, INDIA. DESICCANT PACKAGING AS MANUFACTURED IN BELEN, NM. N&A MENTHOL FLVP FN-6067 AS MANUFACTURED IN BETHLEHEM, PA. N&A PEPPERMINT FLVP FN-6243 AS MANUFACTURED IN BETHLEHEM, PA. QUETIAPINE FUMARATE AS MANUFACTURED IN PUNJAB, INDIA. PHARMACEUTICAL POUCH - FPC SPECIFICATION 47100E AS MANUFACTURED IN ONTARIO, CANADA. PHENYLEPHRINE HYDROCHLORIDE (API) AS MANUFACTURED IN SHENZHEN, CHINA. FEXOFENADINE HYDROCHLORIDE (FORM C) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA.

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4Q2012EXCEL DMF# 18801 18802 18803 18804 I 18805 A 18806 18807 18808 18809 18810 A 18811 18812 18813 18814 18815 18816 18817 A 18818 A 18819 18820 18821 A 18822 18823 A 18824 A 18825 A 18826 18827 18828 18829 18830 A A A A A II II II II IV 9/30/2005 9/30/2005 10/3/2005 9/3/2005 10/4/2005 HELSINN ADVANCED SYNTHESIS SA CADILA HEALTHCARE LTD CADILA HEALTHCARE LTD HIKAL LTD BASF SE II 11/2/2005 II 9/26/2005 ZHEJIANG SUPOR PHARMACEUTICALS CO LTD JANSSEN PHARMACEUTICA NV A II II 9/30/2005 9/29/2005 CADILA HEALTHCARE LTD MALLINCKRODT INC A A III II II 9/27/2005 9/28/2005 9/28/2005 BAYER MATERIALSCIENCE LLC CIPLA LTD CIPLA LTD MAKROBLEND UT 408 RESINS AS MANUFACTURED IN HEBRON, OH. GRANISETRON BASE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA. II 9/23/2005 N N N N A A II II II 9/15/2005 8/31/2005 9/20/2005 A A A A II II II II II 9/25/2005 9/25/2005 9/25/2005 9/26/2005 9/24/2005 DIVIS LABORATORIES LTD DIVIS LABORATORIES LTD DIVIS LABORATORIES LTD LIPOID GMBH JIANGSU HANSOH PHARMACEUTICAL CO LTD NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER HIKAL LTD AUROBINDO PHARMA LTD NATIONAL CENTER FOR NATURAL PRODUCTS RESEARCH FRESENIUS KABI ONCOLOGY LTD GEMFIBROZIL API AS MANUFACTURED IN BANGALORE, INDIA. AMOXICILLIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. II 9/26/2005 STATUS Type SUBMIT DATE I N A II II 9/27/2005 9/19/2005 II 9/2/2005 HOLDER R L FINE CHEM NOT AN ASSIGNED NUMBER JUBILANT LIFE SCIENCES LTD HENAN QUANXIN MEDICAL & CHEMICAL TECHNOLOGY CO LTD ALKERMES GAINESVILLE LLC TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN KARNATAKA, INDIA. SUBJECT IMIPRAMINE PAMOATE AS MANUFACTURED IN BANGALORE, INDIA.

4Q2012

METHYLTESTOSTERONE USP AS MANUFACTURED IN HENAN PROVINCE, CHINA. MELOXICAM NANOCRYSTAL(R) TABLETS AS MANUFACTURED IN KING OF PRUSSIA, PA. FOSPHENYTOIN SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. RISEDRONATE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ZOLPIDEM TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. LIPOID DPPC/PG 7:3 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY. GEMCITABINE HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED BY JIANGSU HANSEN PHARMACEUTICAL CO LTD IN JIANGSU, CHINA.

CANNABIS EXTRACT (PRODUCT CODE 1101), A DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN UNIVERSITY, MS. IRINOTECAN HYDROCHLORIDE TRIHYDRATE (ESUB) AS MANUFACTURED IN WEST BENGAL, INDIA.

ESOMEPRAZOLE MAGNESIUM DIHYDRATE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA. ATORVASTATIN PROTECTED DIOL AS MANUFACTURED IN GUJARAT, INDIA. LEVORPHANOL TARTRATE USP SPECIAL (ESUB) AS MANUFACTURED IN ST. LOUIS, MO. TINIDAZOLE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. DARUNAVIR (R319064) DRUG SUBSTANCE (ESUB) AS MANUFACTURED BY CILAG AG IN SCHAFFHAUSEN, SWITZERLAND, JANSSEN PHARMACEUTICA, NV IN GEEL, BELGIUM AND JANSSEN PHARMACEUTICA LTD IN CORK, IRELAND. ADAPALENE AS MANUFACTURED IN BIASCA, SWITZERLAND. AMLODIPINE BESILATE AS MANUFACTURED IN GUJARAT, INDIA. CANDESARTAN CILEXETIL AS MANUFACTURED IN GUJARAT, INDIA. ONDANSETRON API AS MANUFACTURED IN BANGALORE, INDIA. KOLLICOAT(R) IR WHITE AS MANUFACTURED BY AKTIENGESELLSCHAFT IN LUDWIGSHAFEN, GERMANY AND SHWARZWALDMILCH GMBH IN OFFENBERG, GERMANY.

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4Q2012EXCEL DMF# 18831 A 18832 18833 C 18834 18835 A 18836 A 18837 18838 A 18839 18840 18841 18842 18843 A 18844 A 18845 A 18846 18847 A 18848 A 18849 A 18850 I 18851 A 18852 18853 18854 I 18855 I 18856 I 18857 18858 A A II III 10/11/2005 9/15/2005 DR REDDYS LABORATORIES LTD STYROLUTION GMBH IV 10/7/2005 FONA INTERNATIONAL INC IV 10/7/2005 FONA INTERNATIONAL INC I I IV IV IV 10/7/2005 10/7/2005 10/7/2005 FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC IV 10/7/2005 FONA INTERNATIONAL INC IV 10/7/2005 FONA INTERNATIONAL INC IV 10/3/2005 LUBRIZOL ADVANCED MATERIALS INC II 10/7/2005 ORGAPHARM SAS A II III 10/10/2005 9/30/2005 II 10/7/2005 II 10/7/2005 A I I I II II II II II 10/5/2005 10/3/2005 10/3/2005 10/3/2005 10/7/2005 LUPIN LTD BASIC PHARMA LIFE SCIENCE PVT LTD BASIC PHARMA LIFE SCIENCE PVT LTD BASIC PHARMA LIFE SCIENCE PVT LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD BASF CO LTD ADHESIVES RESEARCH INC A II III 9/30/2005 11/28/2005 SWATI SPENTOSE PRIVATE LTD 3M DRUG DELIVERY SYSTEMS II 10/6/2005 I II II 9/30/2005 10/4/2005 I II II 9/26/2005 1/22/2005 TAI HENG INDUSTRY CO LTD ZHEJIANG MEDICAL CO LTD XINCHANG PHARMACEUTICAL FACTORY MALLINCKRODT INC ZHEJIANG NEO DANKONG PHARMACEUTICAL CO LTD ALEMBIC PHARMACEUTICALS LTD STATUS Type SUBMIT DATE II 9/22/2005 HOLDER CHEMWERTH INC SUBJECT

4Q2012

ADAPALENE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA FOR CHEMWERTH INC URACIL AS MANUFACTURED IN JIANGSU, CHINA FOR TAI HENG INDUSTRY CO LTD MIGLITOL USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. HYDROMORPHONE BASE (ESUB) AS MANUFACTURED IN ST. LOUIS, MO. ATORVASTATIN ATV (L1) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN GUJARAT, INDIA. MELOXICAM AS MANUFACTURED IN GUJARAT, INDIA. BECLOMETHOSON DIPROPIONATE HFA METERED DOSE INHALER VALUE AS MFG IN SCHAUMBURG, IL;COLUMBUS, NE;BOUND BROOK,NJ; BUCKINGHAMSHIRE,LANCASHIRE,STAFFORDSHIRE AND DURHAM, U.K. AMLODIPINE BESILATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. CHLORHEXIDINE ACETATE AS MANUFACTURED IN GUJARAT, INDIA. CHLORHEXIDINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA. CHLORHEXIDINE BASE AS MANUFACTURED IN GUJARAT, INDIA. ARGININE (STERILE BULK) AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA. TERBINAFINE HYDROCHLORIDE (NON-STERILE BULK) AS MANUFACTURED IN MAHARASHTRA, INDIA. CEPHALOSPORIN INTERMEDIATE (CAVA) AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA. RIBOFLAVIN (BULK DRUG SUBSTANCE) AS MANUFACTURED IN JEONBUK, KOREA. A-4389-99 ADHESIVE AS MANUFACTURED BY ADHESIVES RESEARCH INC IN GLEN ROCK, PA AND ADHESIVES RESEARCH IRELAND LIMITED IN LIMERICK, IRELAND. 3-FORMYL-5-METHOXYINDOLE INTERMEDIATE AS MANUFACTURED IN PITHIVIERS, FRANCE. ESTANE PRODUCTS 5714, 58239, 58311, 58630 AS MANUFACTURED IN AVON LAKE, OH AND WESTERLO-OEVEL, BELGIUM. 894.115 N-C PEPPERMINT FLAVOR, NATURAL AS MANUFACTURED IN CAROL STREAM, IL. 915.843 STRAWBERRY FLAVOR, NATURAL WONF AS MANUFACTURED IN CAROL STREAM, IL. 825.746 CHERRY FLAVOR, ARTIFICIAL AS MANUFACTURED IN CAROL STREAM, IL. 950.020 VANILLIN, ARTIFICIAL AS MANUFACTURED IN CAROL STREAM, IL. 884.616 N-C ORANGE FLAVOR, NATURAL & ARTIFICIAL AS MANUFACTURED IN CAROL STREAM, IL. 827.158 W.S. NATURAL & ARTIFICIAL HOT CINNAMON FLAVOR AS MANUFACTURED IN CAROL STREAM, IL. 857.078 GRAPEFRUIT FLAVOR, NATURAL WONF AS MANUFACTURED IN CAROL STREAM, IL. GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. TERLURAN(R) HD-15 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY.

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4Q2012EXCEL DMF# 18859 18860 18861 I 18862 A 18863 A 18864 18865 18866 18867 18868 18869 18870 18871 18872 A 18873 18874 18875 18876 I 18877 18878 18879 18880 I 18881 A 18882 18883 A 18884 I 18885 18886 A 18887 A 18888 A 18889 I II 10/17/2005 ZAMBON S A II 10/14/2005 WANBURY LTD II 10/14/2005 A II II 10/1/2005 10/18/2005 AUROBINDO PHARMA LTD JOHNSON MATTHEY PHARMACEUTICAL MATERIALS WANBURY LTD III 10/14/2005 GERRESHEIMER REGENSBURG GMBH A V II 10/3/2005 10/18/2005 ABBOTT VASCULAR INC QILU TIANHE PHARMACEUTICAL CO LTD IV 10/15/2005 DURECT CORP A A I II II III IV 10/14/2005 10/14/2005 10/16/2006 10/15/2005 NINGBO SMART PHARMACEUTICAL CO LTD AMINO CHEMICALS LTD RKW AG RHEINISCHE KUNSTSTOFFWERKE DURECT CORP A A A III III IV II 10/11/2005 10/4/2005 9/22/2005 10/14/2005 CLARIANT MASTERBATCHES NORDEN AB POLIMERI EUROPA FRANCE SNC RELIANCE CELLULOSE PRODUCTS LTD ELAN DRUG DELIVERY INC A A A A C A A A II II II II II II III III II 10/12/2005 10/14/2005 10/14/2005 10/14/2005 10/14/2005 10/14/2005 10/5/2005 10/5/2005 10/11/2005 DR REDDYS LABORATORIES LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD JUBILANT LIFE SCIENCES LTD MYLAN LABORATORIES LTD KLASSPACK PVT LTD KLASSPACK PVT LTD SYNTHON BV IV 10/11/2005 AEGIS THERAPEUTICS LLC II 10/5/2005 POLYCARBON INDUSTRIES INC STATUS Type SUBMIT DATE A A III III III 10/4/2005 10/4/2005 10/4/2005 HOLDER POLYONE CORP POLYONE CORP MEDRAD INC SUBJECT CC0003828160 15060 WHITE AS MANUFACTURED IN ELK GROVE VILLAGE, IL.

4Q2012

CC10075392WE WHITE #05-089 AS MANUFACTURED IN ELK GROVE VILLAGE, IL. READY TO FILL SYRINGE FLS-I AS MANUFACTURED IN NEUMUNSTER, FEDERAL REPUBLIC OF GERMANY FOR MEDRAD INC PCI-PT6033 PODOPHYLLOTOXIN (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN DEVENS, MA. INTRAVAIL(TM) A-3 (DODECYLMALTOSIDE) AS MANUFACTURED IN SAN LUIS OBISPO, CA AND PISTOIA, ITALY FOR AEGIS THERAPEUTICS LLC. ZOLPIDEM TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. PERINDOPRIL TERT-BUTYLAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CLARITHROMYCIN USP (CLP) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. OLANZAPINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. AZITHROMYCIN MONOHYDRATE AS MANUFACTURED IN KARNATAKA, INDIA. QUETIAPINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. NEUTRAL GLASS AMPOULES AS MANUFACTURED IN MAHARASHTRA, INDIA. NEUTRAL GLASS TUBULAR VIALS AS MANUFACTURED IN MAHARASHTRA, INDIA. AMLODIPINE BESYLATE MONOHYDRATE AS MANUFACTURED BY SYNTHON ARGENTINA SA IN PROVINCIA DE SANTA FE, ARGENTINA FOR SYNTHON BV. PEZ340155X REMAFIN(R) - RED AS MANUFACTURED IN MALMO,SWEDEN. FLEXIRENE MS20 AS MANUFACTURED IN MARDYCK, FRANCE. CROSCARMELLOSE SODIUM USP AS MFG IN A.P. INDIA N1515 NANOCRYSTAL(R) COLLOIDAL DISPERSION AS MANUFACTURED IN KING OF PRUSSIA, PA. DICLOFENAC SODIUM AS MANUFACTURED IN NINGBO, CHINA. VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN MARSA, MALTA. POLYETHYLENE-FILM K460/50 AS MANUFACTURED IN PETERSAURACH, GERMANY CELLULOSE ACETATE BUTYRATE (CAB)-381-20BP, ETHANOL WASHED AS MANUFACTURED IN PELHAM, AL. PHARMACEUTICAL GRADE SAIB (SUCROSE ACETATE ISOBUTYRATE) AS MANUFACTURED IN VACAVILLE, CA. CLINICAL AND NON-CLINICAL STUDIESFOR ABT-578 (ZOTAROLIMUS) TAZOBACTAM ACID (INTERMEDIATE, NON-STERILE BULK) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA. HANDIHALER(R) DEVICE AS MANUFACTURED BY WILDEN PLASTICS (USA) LP IN PEACHTREE CITY, GA AND WILDEN AG MEDICAL PLASTIC SYSTEMS IN PFREIMD, FEDERAL REPUBLIC OF GERMANY. CEFUROXIME SODIUM (STERILE) USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. TETRAHYDROCANNABINOL (THC) IN ETHANOL AS MANUFACTURED IN WEST DEPTFORD, NJ. METFORMIN HYDROCHLORIDE DC GRADE - 90% AS MANUFACTURED IN MAHARASHTRA, INDIA. METFORMIN HYDROCHLORIDE DC GRADE - 95% AS MANUFACTURED IN MAHARASHTRA, INDIA. TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN BARCELONA, SPAIN.

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4Q2012EXCEL DMF# 18890 A 18891 A 18892 18893 18894 18895 A 18896 I 18897 18898 I 18899 A 18900 I 18901 I 18902 A 18903 A 18904 18905 I 18906 I 18907 A 18908 18909 18910 18911 A 18912 18913 I 18914 18915 A 18916 A III 10/25/2005 BORMIOLI ROCCO SPA BU PLASTICS I III II 10/28/2005 11/29/2005 AIRSEC SA JANSSEN PHARMACEUTICA NV A IV III 10/24/2005 10/26/2005 NITIKA PHARMACEUTICAL SPECIALITIES FEDERAL PACKAGE NETWORK INC A I A II II II II 10/24/2005 10/27/2005 10/26/2005 10/11/2005 CONCORD BIOTECH LTD SANDOZ INDUSTRIAL PRODUCTS SA FARMABIOS S P A PHF SA III 10/14/2005 MEDRAD INC II 10/24/2005 RANBAXY LABORATORIES LTD A II III 9/21/2005 10/24/2005 CHENG FONG CHEMICAL CO LTD PET POWER BV II 10/25/2005 II 10/24/2005 II 10/24/2005 ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD SANDOZ INDUSTRIAL PRODUCTS SA IV 10/21/2005 FERRO PFANSTIEHL INC II 10/21/2005 NOVUS FINE CHEMICALS LLC I II II 10/24/2005 10/8/2005 II 10/17/2005 STANDARD CHEMICAL AND PHARMACEUTICAL CO LTD DAIICHI SANKYO CO.LTD AXITEC CO LTD C A A II II II IV 10/21/2005 10/21/2005 10/21/2005 10/21/2005 NEULAND LABORATORIES LTD CHATTEM CHEMICALS INC SIGNA SA DE CV GATTEFOSSE SAS II 10/20/2005 STATUS Type SUBMIT DATE II 10/19/2005 HOLDER ZHEJIANG MEDICINE CO LTD XINCHANG PHARMACEUTICAL FACTORY YAKULT HONSHA CO LTD SUBJECT

4Q2012

VANCOMYCIN HYDROCHLORIDE USP (NON-STERILE API) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. TOTAL SYNTHESIS OF TSN-38B-11 INTERMEDIATE COMPOUND USED IN THE MANUFACTURE OF IRINOTECAN HYDROCHLORIDE TRIHYRATE (CPT-11) DRUG SUBSTANCE AS MANUFACTURED IN GIFU, JAPAN FOR YAKULT HONSHA CO LTD LEVOFLOXACIN HEMIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. BENZPHETAMINE HYDROCHLORIDE AS MANUFACTURED IN CHATTANOOGA, TN. BALSALAZIDE DISODIUM DIHYDRATE AS MANUFACTURED IN TOLUCA, MEXICO. CAPRYOL(R) 90 AND CAPRYOL(R) PGMC AS MANUFACTURED IN SAINT PRIEST, FRANCE. THEOPHYLLINE SODIUM GLYCINATE AS MANUFACTURED IN HSIN-YING, TAIWAN R.O.C. DZ-697B DRUG SUBSTANCE AS MANUFACTURED IN TOKYO, JAPAN. AMIFOSTINE USP (NON-STERILE BULK DRUG) AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA. PHENYLEPHRINE HYDROCHLORIDE AS MANUFACTURED BY NOVUS FINE CHEMICALS LLC IN CARLSTADT, NJ AND MALLADI DRUGS & PHARMACEUTICALS LTD IN TAMIL NADU, INDIA. A,A-TREHALOSE DIHYDRATE, HIGH PURITY(LOW ENDOTOXIN) MULTIPLE COMPENDIAL (T104-1-MC) AS MANUFACTURED IN WAUKEGAN, IL. CEFPROZIL (PROCESS-2) AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA. CEFEPIME HYDROCHLORIDE (NON-STERILE BULK) AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA. PIPERACILLIN SODIUM & TAZOBACTAM SODIUM (8:1), STERILE AS MANUFACTURED IN BARCELONA, SPAIN. MEFENAMIC ACID AS MANUFACTURED IN TAOYUAN COUNTY, TAIWAN R.O.C. PET BOTTLES & CONTAINERS FOR PHARMA AND FOOD APPLICATIONS AS MANUFACTURED IN ETTEN-LEUR, THE NETHERLANDS. SERTRALINE HYDROCHLORIDE DRUG SUBTANCE AS MANUFACTURED IN PUNJAB, INDIA. READY TO FILL SYRINGE FLS-2 AS MANUFACTURED IN NEUMUNSTER, GERMANY FOR MEDRAD INC TACROLIMUS MONOHYDRATE AS MANUFACTURED IN AHMEDABAD, INDIA. ERYTHROMYCIN A (E)-9-OXIME AS MANUFACTURED IN BARCELONA, SPAIN. BUDESONIDE PH. EUR. (MICRONIZED) AS MANUFACTURED IN PAVIA, ITALY. FLUVASTATIN SODIUM HYDRATE (ESUB) AS MANUFACTURED IN QUEBEC, CANADA FOR PHF SA. MAGNESIUM STEARATE USP AS MANUFACTURED IN NAGPUR, INDIA. NO.750 LIGHTWEIGHT PROPEL/REPEL STICK AS MANUFACTURED IN ROGERS AND CHASKA, MN. DESICCANT POLYMER PLATE AS MANUFACTURED IN ROMORANTIN, FRANCE. PALIPERIDONE (R076477) DRUG SUBSTANCE (ESUB) MANUFACTURED IN B-2400 GEEL, BELGIUM AND CO.CORK, IRELAND HDPE BOTTLE 60 ML AS MANUFACTURED IN SAINT SULPICE, FRANCE.

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4Q2012EXCEL DMF# 18917 A 18918 A 18919 A 18920 A 18921 18922 18923 A 18924 18925 18926 18927 A 18928 I 18929 18930 I 18931 18932 A 18933 A 18934 18935 I 18936 A 18937 18938 A 18939 A 18940 A 18941 18942 18943 A 18944 A II 11/9/2005 A A II II II 10/31/2005 11/8/2005 11/8/2005 AUROBINDO PHARMA LTD KIMBERLY CLARK HEALTH CARE ORCHID CHEMICALS AND PHARMACEUTICALS LTD HENAN LIHUA PHARMACEUTICAL CO LTD II 10/25/2005 FIDIA FARMACEUTICI SPA III 11/7/2005 KJ SPECIALTY PAPER CO LTD N III 11/7/2005 NOT AN ASSIGNED NUMBER KJ SPECIALTY PAPER CO LTD II 11/7/2005 LEK PHARMACEUTICALS DD I II II 11/4/2005 11/2/2005 III 11/3/2005 I II II 11/4/2005 9/6/2005 CIPLA LTD HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD VETTER PHARMA FERTIGUNG GMBH AND CO KG RANBAXY LABORATORIES LTD MALLINCKRODT INC A II II 11/2/2005 10/27/2005 II 11/1/2005 REGENT BIO SCIENCE AND TECHNOLOGY CO LTD INTERQUIM SA ARCH PHARMALABS LTD A A N II 10/31/2005 III IV 10/31/2005 11/1/2005 A A II II II 10/24/2005 10/27/2005 10/31/2005 AUROBINDO PHARMA LTD CHEMI SPA ORCHID CHEMICALS AND PHARMACEUTICALS LTD NOVA CHEMICALS CORP SEPPIC SA NOT AN ASSIGNED NUMBER TORAY INDUSTRIES INC III 12/9/2005 RELIANCE INDUSTRIES LTD III 10/14/2005 RELIANCE INDUSTRIES LTD III 10/26/2005 LOPAREX LLC STATUS Type SUBMIT DATE III 10/5/2005 HOLDER BHAVIN CONTAINERS PRIVATE LTD SUBJECT

4Q2012

ALUMINIUM COLLAPSIBLE TUBES SUITABLE FOR PACKAGING PHARMACEUTICAL DASAGES AS MANUFACTURED IN DADRA & NAGAR HAVELI, INDIA. GRADE 27455 D 67# WH PET 2300A/000 C AS MANUFACTURED IN IOWA CITY, IA; EDEN, NC; DIXON, IL AND CULLMAN, AL. POLYVINYL CHLORIDE (PVC) RAW MATERIAL GRADE REON 60-11 AS MANUFACTURED IN GUJARAT, INDIA. POLYVINYLCHLORIDE (PVC) RAW MATERIAL GRADE REON 57-11 RAW MATERIAL AS MANUFACTURED IN GUJARAT, INDIA. MELOXICAM AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CHE001-05 AS MANUFACTURED IN FROSINONE AND MILAN, ITALY. CEFEPIME & ARGININE (STERILE BULK) AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA. SCLAIR(R) FP120-DD AS MANUFACTURED IN ALBERTA, CANADA. SEPINEO SE 68 NALFURAFINE (TRK-820) DRUG SUBSTANCE AS MANUFACTURED IN SHIZUOKA, JAPAN. SODIUM CHONDROITIN SULFATE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA. CICLOPIROX USP AS MANUFACTURED IN BARCELONA, SPAIN. CLOPIDOGREL BISULFATE (USP - XXVIII) AS MANUFACTURED IN MAHARASHTRA, INDIA. ROSIGLITAZONE MALEATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. CYCLOSPORINE (NON-STERILE BULK FORM) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. V-LK(R) S-CARTRIDGE SYSTEM AS MANUFACTURED IN LANGENARGEN, GERMANY. TIAGABINE HYDROCHLORIDE USP AS MANUFACTURED IN PUNJAB, INDIA. SODIUM PHOSPHATE, MONOBASIC MONOHYDRATE USP AS MANUFACTURED IN PHILLIPSBURG, NJ. MYCOPHENOLATE MOFETIL (ACTIVE SUBSTANCE) AS MANUFACTURED IN MENGES, SLOVENIA. MEDICAL BACKING MATERIALS (2 TYPES) OF PET FILM AND UNWOVEN CLOTH LAMINATED WITH A VINYL ACETATE-SERIES ADHESIVE AS MANUFACTURED IN SHIZUOKA, JAPAN MEDICAL BACKING MATERIALS (5 TYPES) OF PET FILM AND UNWOVEN CLOTH LAMINATED WITH A POLYESTER ADHESIVE AS MANUFACTURED IN SHIZUOKA, JAPAN. VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN GARBAGNATE MILANESE, ITALY. CEFPODOXIME PROXETIL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. [14C]-UREA, USP (PYTEST DRUG SUBSTANCE) AS MANUFACTURED IN LENEXA, KS. TRANS RESVERATROL AS MANUFACTURED IN MAHARASHTRA, INDIA. HYDROCORTISONE AS MANUFACTURED IN HENAN, CHINA.

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4Q2012EXCEL DMF# 18945 18946 18947 18948 A 18949 C 18950 I 18951 I 18952 18953 I 18954 A 18955 18956 A 18957 18958 18959 18960 18961 I 18962 18963 18964 A 18965 18966 A 18967 18968 A 18969 I 18970 A 18971 18972 A 18973 A II 11/23/2005 AUROBINDO PHARMA LTD A II II 11/25/2005 11/25/2005 DIVIS LABORATORIES LTD RESOLUTION CHEMICALS LIMITED III 11/7/2005 NYPRO INC II 10/30/2005 POLYMED THERAPEUTICS INC A II III 11/22/2005 11/16/2005 JUBILANT LIFE SCIENCES LTD LPS INDUSTRIES INC VALSARTAN AS MANUFACTURED IN KARNATAKA, INDIA. C II III 11/9/2005 11/21/2005 AUROBINDO PHARMA LTD IWATA LABEL CO LTD A A II II II 11/18/2005 11/18/2005 11/18/2005 SMS PHARMACEUTICALS LTD BCN PEPTIDES PISGAH LABS INC A A A A II II II II II 11/9/2005 11/2/2005 11/9/2005 11/17/2005 11/17/2005 A II II 11/8/2005 1/5/2006 SYN TECH CHEM AND PHARM CO LTD TIANJIN TIANYAO PHARMACEUTICALS CO LTD FIS FABBRICA ITALIANA SINTETICI SPA LONZA AG CHANGZHOU PHARMACEUTICAL FACTORY TARO PHARMACEUTICAL INDUSTRIES LTD BIOCRYST PHARMACEUTICALS INC II 11/14/2005 CILAG AG A II III 11/11/2005 11/15/2005 CADILA HEALTHCARE LTD MITSUI CHEMICALS AMERICA INC II 11/11/2005 SUMITOMO CHEMICAL CO LTD II 11/10/2005 II 11/9/2005 TEVA PHARMACEUTICAL INDUSTRIES LTD STATUS Type SUBMIT DATE A I A III III II II 11/4/2005 11/8/2005 11/8/2005 11/9/2005 HOLDER POLYONE CORP POLIMOON MEDICAL PACKAGING AS ROLABO OUTSOURCING SL TEVA PHARMACEUTICAL INDUSTRIES LTD SUBJECT CC00002580WE 10037533 BURGUNDY AS MANUFACTURED IN ELK GROVE, IL. 30 ML CONTAINER AS MANUFACTURED IN LANGESKOV, DENMARK. TRANDOLAPRIL AS MANUFACTURED IN ZARAGOZA, SPAIN.

4Q2012

FEXOFENADINE BASE AS MANUFACTURED IN NETANYA, ISRAEL AND SETTIMO MILANESE MI AND VILLANTERIO PV, ITALY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD. FEXOFENADINE HYDROCHLORIDE AS MANUFACTURED BY PLANTEX LTD. CHEMICAL INDUSTRIES AND ABIC LTD IN NETANYA, ISRAEL AND ASSIA CHEMICAL INDUSTRIES LTD IN BE'ER SHEVA, ISRAEL.

PHARMACEUTICAL WORKS POLPHARMA SA ENALAPRIL MALEATE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND. PBL (A STARTING MATERIAL FOR MANUFACTURING DRUG SUBSTANCES) AS MANUFACTURED IN GIFU PREFECTURE, JAPAN. ZIPRASIDONE HYDROCHLORIDE ANHYDROUS AS MANUFACTURED IN GUJARAT, INDIA. ADMER(R) SF731 AS MANUFACTURED IN CHIBA, JAPAN FOR MITSUI CHEMICALS AMERICA INC FOSPHENYTOIN SODIUM DRUG SUBSTANCE (ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN SCHAUFFHAUSEN, SWITZERLAND. PHENYLTOLOXAMINE CITRATE AS MANUFACTURED IN HSIN-YING, TAIWAN R.O.C. METHYLPREDNISOLONE ACETATE (BULK) USP AS MANUFACTURED IN TIANJIN, CHINA. ENAMINE AMIDE (FIS0448) AS MANUFACTURED IN VICENZA, ITALY. EC-037 AS MANUFACTURED IN VISP, SWITZERLAND. DOXYCYCLINE MONOHYDRATE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA. LAMOTRIGINE AS MANUFACTURED IN HAIFA BAY, ISRAEL. PERAMIVIR DRUG SUBSTANCE AS MANUFACTURED BY CILAG AG IN SCHAFFHAUSEN, SWITZERLAND. ALMOTRIPTAN MALATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. TETRACOSACTIDE AS MANUFACTURED IN BARCELONA, SPAIN. ZOLEDRONIC ACID MONOHYDRATE (ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN PISGAH FOREST, NC. AMLODIPINE BESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. SHRINKTACK LABEL AS MANUFACTURED IN AICHI AND TOCHIGI PREFECTURES, JAPAN.

LAMINATIONS VF42, VF43, VF45, VF48, VF49, VF15, VF16, VF54 AND VF60 AS MANUFACTURED IN MOONACHIE, NJ. IRINOTECAN HYDROCHLORIDE TRIHYDRATE (NON-STERILE BULK) DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA FOR POLYMED THERAPEUTICS INC OCUMETER(R) PLUS VIAL AS MANUFACTURED IN FONTENAY SUR EURE, FRANCE FOR NYPRO INC TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CABERGOLINE DRUG SUBSTANCE AS MANUFACTURED IN HERTFORDSHIRE, UNITED KINGDOM. RIBAVIRIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. Page 565

4Q2012EXCEL DMF# 18974 18975 18976 I 18977 18978 A 18979 A 18980 18981 A 18982 18983 18984 18985 C 18986 18987 A 18988 C 18989 18990 18991 A 18992 I 18993 A 18994 A 18995 A 18996 18997 18998 A 18999 19000 19001 A 19002 19003 A A II II 12/5/2005 11/11/2005 TEVA PHARMACEUTICAL INDUSTRIES LTD GE HEALTHCARE BIO SCIENCES CORP DEXRAZOXANE (ICRF-187) AS MANUFACTURED IN MILANO, ITALY. BF-1400 FILM CELLBAG(R) AS MANUFACTURED IN SOMERSET, NJ. A A IV II II 11/28/2005 12/4/2005 12/5/2005 I C II II II 12/1/2005 11/25/2005 11/30/2005 II 11/28/2005 SHANDONG NEW TIME PHARMACEUTICAL CO LTD EURAND INC KEMIRA CHEMSOLUTIONS BV LABORATORIO CHIMICO INTERNAZIONALE SPA COGNIS GMBH DIVIS LABORATORIES LTD KYOWA HAKKO BIO CO LTD II 12/2/2005 VALEANT INTERNATIONAL BERMUDA III 12/2/2005 JSR LIFE SCIENCES CORP. II 12/2/2005 BELCHER PHARMACEUTICALS INC I A II II II 11/28/2005 11/30/2005 11/30/2005 IVAX PHARMACEUTICALS SRO DAINIPPON SUMITOMO PHARMA CO LTD SUMITOMO CHEMICAL CO LTD II 11/28/2005 TEVA PHARMACEUTICAL INDUSTRIES LTD A II II 8/4/2005 11/30/2005 I I A II II II II 11/28/2005 11/28/2005 11/24/2005 11/28/2005 TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD QUIMICA SINTETICA SA CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD CADILA PHARMACEUTICALS LTD CATALENT PHARMA SOLUTIONS LLC ZOLPIDEM TARTRATE AS MANUFACTURED IN ZAGREB, CROATIA. VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN ZAGREB, CROATIA. MELOXICAM AS MANUFACTURED IN MADRID, SPAIN. TACROLIMUS AS MANUFACTURED IN TAIPEI, TAIWAN R.O.C. ZOLPIDEM TARTRATE AS MANUFACTURED IN GUJARAT, INDIA. A II II 11/23/2005 11/29/2005 II 11/18/2005 PRIME EUROPEAN THERAPEUTICS SPA EUTICALS SPA AUROBINDO PHARMA LTD SIFAVITOR SRL A II II 11/28/2005 11/28/2005 STATUS Type SUBMIT DATE A I II II II 11/16/2005 11/28/2005 4/8/2007 HOLDER AUROBINDO PHARMA LTD DSM NUTRITIONAL PRODUCTS LTD SUBJECT ZOLPIDEM TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. 5-FLUOROURACIL AS MANUFACTURED IN SISSELN, SWITZERLAND.

4Q2012

JIANGSU ZHONGDAN PHARMACEUTICAL CO NABUMETONE (ESUB) AS MANUFACTURED IN JIANGSU CHINA LTD ACS DOBFAR SPA CEFOTETAN DISODIUM (STERILE BULK) AS MANUFACTURED IN MILANO, ITALY. GRANULES INDIA LTD COMPRESSO PAP 90 CPL, ORAL (DIRECTLY COMPRESSIBLE GRANULES OF ACETAMINOPHEN 90%) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. RITALINIC ACID AS MANUFACTURED IN ORIGGIO, ITALY. FLUOXETINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. BUTOCONAZOLE NITRATE AS MANUFACTURED IN MURCIA, SPAIN FOR MEDIOLAST SPA

SANDIMMUNE 25 MG AND 100 MG SOFTGELS AS MANUFACTURED IN ST. PETERSBURG, FL. METHYLERGONOVINE MALEATE USP AS MANUFACTURED IN OPAVA, CZECH REPUBLIC. MYCOPHENOLATE MOFETIL USP AS MANUFACTURED IN OPAVA, CZECH REPUBLIC. SM-5887 (AMRUBICIN HYDROCHLORIDE) AS MANUFACTURED IN TSURUSAKI, JAPAN. PBL (A STARTING MATERIAL FOR MANUFACTURING DRUG SUBSTANCES) AS MANUFACTURED IN OKAYAMA PREFECTURE, JAPAN. OMEPRAZOLE PELLETS (8.5% W/W) AS MANUFACTURED BY MURLI KRISHNA PHARMA PVT LTD IN MAHARASHTRA, INDIA. STYRENE ISOPRENE BLOCK COPOLYMER (JSR SIS5002), STYRENIC THERMOPLASTIC ELASTOMERS AS MANUFACTURED IN IBARAKI, JAPAN, FOR JSR CORP METFORMIN AQ 1000 MG EXTENDED RELEASE TABLETS AS MANUFACTURED IN STEINBACH, MANITOBA, CANADA FOR VALEANT INTERNATIONAL BARBADOS SRL ISOFLURANE (NON-STERILE BULK) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA. EUR-1038 MODIFIED RELEASE CAPSULES AS MANUFACTURED IN VANDALIA, OH. CALCIUM ACETATE AS MANUFACTURED IN PAPESTEEG, THE NETHERLANDS. ALPHA LIPOIC ACID AS MANUFACTURED IN MILANO, ITALY. PLANTACARE 2000 UP AS MANUFACTURED IN DUSSELDORF, GERMANY. GABAPENTIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA. D-SERINE (BULK SUBSTANCE) AS MANUFACTURED IN YAMAGUCHI PREFECTURE, JAPAN.

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4Q2012EXCEL DMF# 19004 A 19005 I 19006 19007 I 19008 19009 19010 19011 19012 I 19013 19014 19015 19016 I 19017 A 19018 I 19019 19020 19021 19022 19023 A 19024 19025 19026 A 19027 19028 A 19029 19030 I 19031 A 19032 C 19033 C II 12/15/2005 TEVA PHARMACEUTICAL INDUSTRIES LTD II 12/15/2005 II 12/14/2005 ORCHID CHEMICALS AND PHARMACEUTICALS LTD TEVA PHARMACEUTICAL INDUSTRIES LTD I II II 12/9/2005 12/9/2005 I III II 12/5/2005 12/13/2005 ROLLPRINT PACKAGING PRODUCTS INC MICRONISIERUNGS KONTOR OBERROT GMBH ALPHARMA APS ALPHARMA APS I A II II II 12/14/2005 12/13/2005 12/10/2005 ESTEVE QUIMICA SA CAMBRIDGE MAJOR LABS INC AKSHAT PHARMA PRIVATE LTD A A A A II II II II III 12/8/2005 1/4/2006 12/5/2005 12/9/2005 12/9/2005 II 12/6/2005 II 11/21/2005 A A A II II II II 11/28/2005 12/8/2005 12/13/2005 12/6/2005 AUROBINDO PHARMA LTD SUN PHARMACEUTICAL INDUSTRIES LTD GADOR SA A A A I II II II II II 12/2/2005 12/5/2005 12/7/2005 12/7/2005 12/7/2005 A II II 11/28/2005 12/5/2005 R L FINE CHEM CHANGZHOU QIANHONG BIO PHARMA CO LTD RELIABLE BIOPHARMACEUTICAL CORP CHEMAGIS LTD RANBAXY LABORATORIES LTD RANBAXY LABORATORIES LTD RANBAXY LABORATORIES LTD II 12/7/2005 TEVA PHARMACEUTICALS INDUSTRIES LTD STATUS Type SUBMIT DATE III 12/6/2005 HOLDER EMS CHEMIE NORTH AMERICA INC SUBJECT

4Q2012

GRIVORY G21 NATURAL AS MANUFACTURED BY EMS-CHEMIE AG IN DOMAT/EMS, SWITZERLAND IN EMS-CHEMIE (NORTH AMERICA) INC. ZIPRASIDONE HYDROCHLORIDE AS MANUFACTURED IN BE'ER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD LORAZEPAM AS MANUFACTURED IN KARNATAKA, INDIA. HEPARIN SODIUM USP AS MANUFACTURED IN JIANGSU, CHINA. PROTAMINE SULFATE USP AS MANUFACTURED IN ST. LOUIS, MO. IMIQUIMOD AS MANUFACTURED IN BEER SHEVA, ISRAEL. REPAGLINIDE USP AS MANUFACTURED IN PUNJAB, INDIA. CEFDITOREN PIVOXIL DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA. CEFDITOREN SODIUM INTERMEDIATE DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA. BENAZEPRIL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. DESLORATADINE AS MANUFACTURED IN MAHARASHTRA, INDIA. ZALEPLON AS MANUFACTURED IN PROVINCIA DE BUENOS AIRES, ARGENTINA.

INTERNATIONAL MEDICATION SYSTEMS LTD SODIUM NITRITE INJECTION USP, 30 MG / ML, 10 ML AS MANUFACTURED IN S. EL MONTE, CA. ALBEMARLE CORP ALBE-TAB(TM) IBUPROFEN 90 (IBUPROFEN 90) AS MANUFACTURED IN ORANGEBURG, SC. LABORATOIRES FOURNIER SA FENOFIBRATE SPRAY GRANULATION INTERMEDIATE AS MANUFACTURED IN FONTAINELES-DIJON, FRANCE. HIKAL LTD TRIPROLIDINE HYDROCHLORIDE API AS MANUFACTURED IN BANGALORE, INDIA. UNIQUE CHEMICALS SMRUTHI ORGANICS LTD NOF CORP 3M DRUG DELIVERY SYSTEMS DICLOFENAC DIETHYAMINE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA. NORFLOXACIN USP AS MANUFACTURED IN MAHARASHTRA, INDIA. DIERUCOYL PHOSPHATIDYLCHOLINE (DEPC) AS MANUFACTURED IN HYOGO, JAPAN. FORMOTEROL FUMARATE/MOMETASONE FUROATE PMDI ACTUATOR AS MANUFACTURED IN DUBLIN, IRELAND. MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN TARROGONA, SPAIN. ANASTROZOLE FP-046 AS MANUFACTURED IN GERMANTOWN, WI. GLYCOPYRROLATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR AKSHAT PHARMA PRIVATE LIMITED RPP #36-1210 AS MANUFACTURED IN ADDISON, IL AND BLOOMFIELD, CT. CICLESONIDE, MICRONIZED (ITEM NO. 37) AS MANUFACTURED IN OBERROT, GERMANY. TOBRAMYCIN BASE USP (NON-STERILE BULK) AS MANUFACTURED TOBRAMYCIN SULPHATE USP (NON-STERILE BULK) AS MANUFACTURED BY FUJIAN FUKANG PHARMACEUTICALS CO LTD IN FUZHOU, CHINA. PIPERACILLIN AS MANUFACTURED IN MAHARASHTRA, INDIA. LINEZOLID AS MANUFACTURED IN NETANYA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD LEVETIRACETAM AS MANUFACTURED IN BE'ER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD

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4Q2012EXCEL DMF# 19034 A 19035 19036 19037 19038 19039 A 19040 19041 19042 19043 19044 19045 19046 19047 19048 19049 A 19050 C 19051 19052 19053 A 19054 19055 19056 19057 A 19058 19059 19060 A 19061 I 19062 19063 19064 I 19065 A 19066 A III 12/22/2005 BIRGI SANAYI AS III 12/22/2005 A C II II II 12/19/2005 12/23/2005 12/20/2005 SOFRADIM PRODUCTION EUTICALS INC ZHEJIANG HISOAR PHARMACEUTICAL CO LTD BIRGI SANAYI AS II 12/22/2005 INTRALYTIX INC A I II III II 12/21/2005 12/22/2005 12/21/2005 APOTEX PHARMACHEM INDIA PVT LTD SYNTHETIC RUBBER TECHNOLOGIES INC RANBAXY LABORATORIES LTD I I A II III II III 12/19/2005 12/6/2005 12/8/2005 12/6/2005 BRIDGE ORGANICS CO INDIAN PETROCHEMICAL CORP LTD ANHUI WANBEI PHARMACEUTICAL CO LTD TECHNOFLEX Z4124 FINAL INTERMEDIATE AS MANUFACTURED IN VICKSBURG, MI. A A II II II 12/19/2005 12/17/2005 12/19/2005 RANBAXY LABORATORIES LTD MYTHEN SPA SCINOPHARM TAIWAN LTD II 12/20/2005 PLIVA LACHEMA AS I I A A A A A A A II II IV II II II II II II II 12/15/2005 12/16/2005 12/19/2005 12/1/2005 12/13/2005 12/19/2005 11/30/2005 12/22/2005 12/16/2005 12/21/2005 DAINIPPON SUMITOMO PHARMA CO LTD AVANTI POLAR LIPIDS INC NOF CORP SECOND PHARMA CO LTD CONCORD BIOTECH LTD USV LIMITED AUROBINDO PHARMA LTD SUN PHARMACEUTICAL INDUSTRIES LTD JUBILANT LIFE SCIENCES LTD RANBAXY LABORATORIES LTD A A A A II II II II III 12/13/2005 12/17/2005 12/9/2005 12/15/2005 12/16/2005 WANBURY LTD RANBAXY LABORATORIES LTD AUROBINDO PHARMA LTD RELIABLE BIOPHARMACEUTICAL CORP NYPRO INC STATUS Type SUBMIT DATE II 12/16/2005 HOLDER TEVA PHARMACEUTICAL INDUSTRIES LTD SUBJECT

4Q2012

ANASTROZOLE AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO AND RHO, ITALY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD SERTRALINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA. ZOLPIDEM TARTRATE DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA. RITONAVIR AS MANUFACTURED IN ANDHRA PRADESH, INDIA DALTEPARIN SODIUM AS MANUFACTURED IN ST. LOUIS, MO. PROVENTIL(R) HFA (ALBUTEROL SULFATE) INHALATION AEROSOL ACTUATOR & DUST CAP AS MANUFACTURED BY NYPRO IRELAND IN COUNTY DUBLIN, IRELAND. SMP-028 AS MANUFACTURED IN OSAKA, JAPAN. DSPE-PEG2000 MALEIMIDE AS MANUFACTURED IN ALABASTER, AL. DSPE-PEG5000 AS MANUFACTURED IN KANAGAWA, JAPAN. AMLODIPINE BESILATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. SIMVASTATIN USP AS MANUFACTURED IN AHMEDABAD, INDIA. ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA. QUINAPRIL HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. SERTRALINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA. DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN KARNATAKA, INDIA. GANCICLOVIR (INTERMEDIATE DRUG SUBSTANCE) AS MANUFACTURED IN GUJARAT, INDIA. IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN BRNO, CZECH REPUBLIC. LEVETIRACETAM AS MANUFACTURED IN PUNJAB, INDIA. DEFEROXAMINE MESYLATE NT AS MANUFACTURED IN CORANA, ITALY. GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN R.O.C.

POLYETHYLENE (PE) INDOTHENE 22FA002 AS MANUFACTURED IN GUJARAT, INDIA. LINCOMYCIN HYDROCHLORIDE USP AS MANUFACTURED IN ANHUI, CHINA. CONTAINERS AND CLOSURE SYSTEM FOR INJECTABLE SOLUTION AND DRUGS AS MANUFACTURED IN BIDART, FRANCE. ENALAPRIL MALEATE USP AS MANUFACTURED IN BANGALORE, INDIA RUBBER AND POLYMERIC COMPOUNDS VALGANCICLOVIR HYDROCHLORIDE (NON-STERILE BULK) AS MANUFACTURED IN MADHYA PRADESH, INDIA. WPP-201, A BACTERIOPHAGE COCKTAIL FOR P. AERUGINOSA, S. AUREUS, AND E. COLI AS MANUFACTURED IN BALTIMORE, MD. PORCINE ATELOCOLLAGEN CPP AS MANUFACTURED IN TREVOUX, FRANCE. METHYLPHENIDATE HYDROCHLORIDE USP AS MANUFACTURED IN SPRINGFIELD, MO. CALCIUM POLYCARBOPHIL AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. 1-30 ML COLOURLESS AMPOULES FOR INJECTABLES MADE OF TUBULAR GLASS AS MANUFACTURED IN ISTANBUL, TURKEY. 1-30 ML AMBER AMPOULES FOR INJECTABLES MADE OF TUBULAR GLASS AS MANUFACTURED IN ISTANBUL, TURKEY. Page 568

4Q2012EXCEL DMF# 19067 A 19068 A 19069 C 19070 A 19071 A 19072 A 19073 19074 19075 19076 19077 19078 A 19079 19080 19081 19082 A 19083 19084 A 19085 19086 A 19087 A 19088 19089 19090 19091 I 19092 19093 A 19094 I 19095 19096 A A II II 1/6/2006 1/5/2006 HETERO DRUGS LTD TIANJIN TIANYAO PHARMACEUTICALS CO LTD II 1/3/2006 A II II 1/6/2006 1/6/2006 A A A II II II II 12/24/2005 1/3/2006 12/20/2005 12/20/2005 III 1/2/2006 A II III 1/4/2006 1/2/2006 TRIFARMA SPA HINDALCO INDUSTRIES LTD KOLLUR WORKS HINDALCO INDUSTRIES LTD KOLLUR WORKS AUROBINDO PHARMA LTD BASF SE TEVA PHARMACEUTICAL INDUSTRIES LTD SHANDONG NEW TIME PHARMACEUTICAL CO LTD SUVEN LIFE SCIENCES LTD AMRI RENSSELAER INC SUB ALBANY MOLECULAR RESEARCH INC EXOPHARM COMPANY LTD A II II 12/27/2005 12/30/2005 LUPIN LTD NAVINTA LLC A A A II II II II 12/30/2005 12/30/2005 1/3/2006 12/16/2005 A I A I A II II II II III II 12/21/2005 12/21/2005 12/27/2005 12/28/2005 12/22/2005 12/15/2005 II 12/22/2005 ZHEJIANG HISUN PHARMACEUTICAL CO LTD TACROLIMUS (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. CUNO INC BIOASSURE(TM) FILTER PRODUCTS AS MANUFACTURED IN MERIDEN, CT. CUNO INC VIVIMED LABS LTD RANBAXY LABORATORIES LTD POLYONE CORP BIOLIFE(TM) FILTER PRODUCTS AS MANUFACTURED IN MERIDEN, CT. TRICLOSAN USP AS MANUFACTURED IN KARNATAKA, INDIA. CILOSTAZOL DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA. CC00018519DR COLORANT PRODUCT AS MANUFACTURED IN GLENDALE, AZ. II 12/19/2005 AUROBINDO PHARMA LTD II 12/24/2005 II 12/14/2005 III 12/22/2005 STATUS Type SUBMIT DATE III 12/22/2005 HOLDER BIRGI SANAYI AS SUBJECT

4Q2012

2-30 ML COLOURLESS INJECTION VIALS MADE OF TUBULAR GLASS AS MANUFACTURED IN ISTANBUL, TURKEY. BIRGI SANAYI AS 2-30 ML AMBER INJECTION VIALS MADE OF TUBULAR GLASS AS MANUFACTURED IN ISTANBUL, TURKEY. ZHEJIANG HISUN PHARMACEUTICAL CO LTD ACARBOSE (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. APICORE LLC GRANISETRON HYDROCHLORIDE (ESUB) AS MANUFACTURED IN SOMERSET, NJ. ONDANSETRON HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

HUBEI BIOCAUSE PHARMACEUTICAL CO LTD GRANISETRON HYDROCHLORIDE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN WUHAN, CHINA. SIGMA ALDRICH MANUFACTURING LLC N-DODECYL B-D-MALTOSIDE AS MANUFACTURED IN ST. LOUIS, MO. LUPIN LTD NV ORGANON FINE ORGANICS LTD LEVETIRACETAM AS MANUFACTURED IN MAHARASHTRA, INDIA. FENTANYL CITRATE AS MANUFACTURED IN APELDOORN, THE NETHERLANDS. KETAMINE HYDROCHLORIDE AS MANUFACTURED IN MIDDLESBROUGH, UNITED KINGDOM. DESLORATADINE AS MANUFACTURED IN MAHARASHTRA, INDIA. ROPIVACAINE HYDROCHLORIDE FOR INJECTION AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR NAVINTA LLC FOSCARNET SODIUM HEXAHYDRATE AS MANUFACTURED IN MILANO, ITALY. STRIP PACKAGING ALUMINIUM FOIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA. BLISTER PACKAGING ALUMINIUM FOIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ESCITALOPRAM OXALATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. TAZAROTENE AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY. ERGONOVINE MALEATE AS MANUFACTURED IN OPAVA, CZECH REPUBLIC. SEVOFLURANE (NON-STERILE BULK FORM) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA. ENTACAPONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. VORINOSTAT DRUG SUBSTANCE AS MANUFACTURED IN RENSSELAER, NY. VINORELBINE TARTRATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN SHANGHAI PROVINCE, CHINA FOR EXOPHARM COMPANY LTD PERINDOPRIL TERT-BUTYLAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. TRIAMCINOLONE ACETONIDE (BULK) USP AS MANUFACTURED IN TIANJIN, CHINA.

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4Q2012EXCEL DMF# 19097 19098 19099 19100 19101 A 19102 A 19103 A 19104 19105 19106 19107 I 19108 A 19109 C 19110 19111 A 19112 A 19113 19114 A 19115 19116 A 19117 19118 19119 19120 A 19121 A 19122 A 19123 A III 1/6/2006 AMPACET CORP III 1/6/2006 AMPACET CORP III 1/6/2006 AMPACET CORP A A A II III II III 1/19/2006 1/20/2006 1/16/2006 1/6/2006 AREVIPHARMA GMBH SHINKO CHEMICAL CO LTD MOEHS IBERICA SL AMPACET CORP I II III 1/19/2006 12/15/2005 NEULAND LABORATORIES LTD BASELL POLYOLEFINE ITALIA SRL A II II 1/18/2006 12/23/2005 APOTEX PHARMACHEM INC BIOIBERICA SA II 1/18/2006 N S CHEMICALS A III II 1/13/2006 1/12/2006 NAIGAI GLASS INDUSTRY CO LTD YUNNAN HANDE BIO TECH CO LTD II 1/12/2006 III 1/13/2006 SENAWANG LAMINATING TECHNOLOGIES SDN BHD MACFARLAN SMITH LTD A A A II II II II 1/10/2006 12/31/2005 1/6/2006 1/16/2006 HIKAL LTD LUPIN LTD AUROBINDO PHARMA LTD ELAN DRUG DELIVERY INC IV 10/28/2005 EVONIK INDUSTRIES AG IV 10/28/2005 EVONIK INDUSTRIES AG STATUS Type SUBMIT DATE A A A A II II II III III 1/10/2006 1/10/2006 1/10/2006 1/10/2006 1/10/2006 HOLDER MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD EVONIK TECHNOCHEMIE GMBH 3M DRUG DELIVERY SYSTEMS 3M DRUG DELIVERY SYSTEMS SUBJECT SILDENAFIL CITRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. RIZATRIPTAN BENZOATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. D-PENICILLAMINE AS MANUFACTURED IN HANAU, GERMANY.

4Q2012

COTRAN(TM) 9719 POLYETHYLENE FILM AS MANUFACTURED IN BROOKINGS, SD. SCOTCHPAK(TM) 9680, 2-MIL POLYESTER FILM LAMINATE AS MANUFACTURED IN COTTAGE GROVE, MN AND DECATUR, AL FOR 3M DRUG DELIVERY SYSTEMS RESOMER(R) R FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN INGELHEIM, GERMANY IN BLANQUEFORT, FRANCE. RESOMER(R) RG FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN INGELHEIM, GERMANY AND BLANQUEFORT, FRANCE FOR BOEHRINGER INGELHEIM PHARMA GMBH & CO KG. LEVETIRACETAM API AS MANUFACTURED IN BANGALORE, INDIA. ESCITALOPRAM OXALATE (ESUB) CARVEDILOL AS MANUFACTURED IN ANDHRA PRADESH, INDIA. N1504 NANOCRYSTAL(R) COLLOIDAL DISPERSION - STERILE INTERMEDIATE AS MANUFACTURED IN KING OF PRUSSIA, PA. SL5825A, CLEAR LAMINATE FOR MEDICAL PACKAGING AS MANUFACTURED IN NEGERI SEMBILAN, MALAYSIA. BUPRENORPHINE HYDROCHLORIDE AS MANUFACTURED IN SCOTLAND, UNITED KINGDOM. AMPOULE AND VIAL AS MANUFACTURED IN OSAKA, JAPAN. PACLITAXEL DRUG SUBSTANCE ISOLATED FROM TAXUS CANADENSIS AS MANUFACTURED IN KUNMING, CHINA. PARA CHLORO META XYLENOL (PCMX), USP AS MANUFACTURED IN MAHARASHTRA, INDIA. MOEXIPRIL HYDROCHLORIDE AS MANUFACTURED IN ONTARIO, CANADA. CHONDROITIN SULFATE SODIUM SHARK INJECTABLE GRADE AS MANUFACTURED IN BARCELONA, SPAIN. FLUTICASONE PROPIONATE PH.EUR AS MANUFACTURED IN ANDHRA PRADESH, INDIA. PURELL ACP 6541 A (POLYETHYLENE HIGH DENSITY) AS MANUFACTURED BY BISELL POLYOLEFINE GMBH IN FRANKFURT AM MAIN AND MUENCHSMUENSTER, GERMANY FOR BISELL POLYOLEFINE ITALIA SRL. TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN RADEBEUL, GERMANY. EYEDROP CONTAINER TYPE 6 AS MANUFACTURED IN ISHIKAWA, JAPAN. MICRONISED FENOFIBRATE AS MANUFACTURED IN BARCELONA, SPAIN. 100664-K RELEASY 64 POLYETHYLENE MASTERBATCH AS MANUFACTURED IN RAYONG, THAILAND. 100665-K RELEASY 65 POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN RAYONG, THAILAND. 11447-K BLOMITE 47 POLYETHYLENE MASTERBATCH AS MANUFACTURED IN RAYONG, THAILAND. 11343-K PROMITE 43 POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN RAYONG, THAILAND.

Page 570

4Q2012EXCEL DMF# 19124 A 19125 A 19126 19127 19128 A 19129 A 19130 19131 A 19132 19133 I 19134 I 19135 I 19136 19137 19138 A 19139 A 19140 19141 19142 19143 A 19144 A 19145 19146 19147 A 19148 19149 19150 19151 19152 A A A A A II II IV II II 2/2/2006 1/31/2006 2/3/2006 2/3/2006 1/30/2006 AMINO CHEMICALS LTD ANQIU LUAN PHARMACEUTICAL CO LTD EVONIK DEGUSSA CORP CAMBRIDGE MAJOR LABS INC AUROBINDO PHARMA LTD A A III III III 2/1/2006 2/1/2006 2/1/2006 BORMIOLI ROCCO AND FIGLIO SPA BORMIOLI ROCCO SPA BU PLASTICS BORMIOLI ROCCO SPA BU PLASTICA IV 1/30/2006 NITTO DENKO CORP A A A II II II II 1/27/2006 1/31/2006 1/26/2006 1/20/2006 NEKTAR THERAPEUTICS GLENMARK GENERICS LTD CHENGDA PHARMACEUTICALS CO LTD WANBURY LTD PEG2MAL40K/B AS MANUFACTURED IN HUNTSVILLE, AL. OLMESARTAN MEDOXOMIL AS MANUFACTURED IN GUJARAT, INDIA. LEVOCARNITINE USP AS MANUFACTURED IN ZHEJIANG, CHINA. II 1/25/2006 SCINOPHARM TAIWAN LTD I I IV IV II 1/26/2006 1/26/2006 1/26/2006 FONA INTERNATIONAL INC FONA INTERNATIONAL INC EVONIK TECHNOCHEMIE GMBH 861.094 HONEY FLAVOR, ARTIFICIAL AS MANUFACTURED IN GENEVA, IL. IV 1/26/2006 II 1/22/2006 A II II 1/26/2006 1/22/2006 KATAYAMA SEIYAKUSYO CO LTD WORLD JIANGSU INDUSTRY CO LTD A III II 1/13/2006 1/25/2006 EXEMPLAR PHARMACEUTICALS LLC CIPLA LTD II 1/25/2006 SUN PHARMACEUTICAL INDUSTRIES LTD A I II IV II 1/23/2006 1/19/2006 1/24/2006 XIAN LIJUN PHARMACEUTICAL CO LTD ALBEMARLE CORP CYALUME SPECIALTY PRODUCTS INC III 1/13/2006 KIRCHNER SIMON AND CO GMBH STATUS Type SUBMIT DATE III 1/13/2006 HOLDER KIRCHNER SIMON AND CO GMBH SUBJECT

4Q2012

O28L89070 TAMPER EVIDENT CAP PP 28 WITH HOLE 5 MM MADE OF PP WHITE WITH TAMPER EVIDENT RING MADE OF PP BLUE AND INJECTED JOINT MADE OF TPE AS MANUFACTURED IN OESTRICH-WINKEL, GERMANY. OV2889070 TAMPER EVIDENT CAP PP 28 MADE OF PP WHITE WITH TAMPER EVIDENT RING MADE OF PP BLUE AND INJECTED JOINT MADE OF TPE AS MANUFACTURED IN OESTRICH-WINKEL, GERMANY. ERYTHROMYCIN THIOCYANATE AS MANUFACTURED IN SHAANXI, CHINA. AZONE(R), AN INACTIVE INGREDIENT AS MANUFACTURED IN DAYTON, OH. CHLORHEXIDINE GLUCONATE 20% SOLUTION, USP AS MANUFACTURED IN BOUND BROOK, NJ. DONEPEZIL HYDROCHLORIDE (ACTIVE SUBSTANCE) AS MANUFACTURED IN MAHARASHTRA, INDIA. HFA 134A PLACEBO AS MANUFACTURED IN FALL RIVER, MA. LEVO SALBUTAMOL HYDROCHLORIDE/LEVALBUTEROL HYDROCHLORIDE, ACTIVE PHARMACEUTICAL INGREDIENT (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. LOMEFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN TOYAMA, JAPAN.

BACITRACIN ZINC USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN FUJIANG, CHINA. JIANGSU SUNNY HEALTH INDUSTRY CO LTD GALANTAMINE HYDROBROMIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN JIANGSU, CHINA. FONA INTERNATIONAL INC 833.051 N-C NATURAL & ARTIFICIAL COFFEE FLAVOR AS MANUFACTURED IN GENEVA, IL.

857.080 NATURAL GRAPEFRUIT EXTRACT (WONF) AS MANUFACTURED IN GENEVA, IL. LISINOPRIL DIHYDRATE AS MANUFACTURED IN HANAU, GERMANY AND HAM, FRANCE FOR DEGUSSA AG. LETROZOLE DRUG SUBSTANCE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN R.O.C.

GLUCOSAMINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR WANBURY LTD PHARMACEUTICAL ADHESIVE FOR TRANSDERMAL SYSTEM: AV-V SOLUTION AS MANUFACTURED IN MIYAGI, JAPAN. PET BOTTLE 100 ML-FI8095 AS MANUFACTURED IN SAINT SULPICE, FRANCE. TAMPER EVIDENT CLOSURE 28 MM AS MANUFACTURED IN SAINT SULPICE, FRANCE. CHILD RESISTANT CLOSURE 28 MM: CHILD RESISTANT PLUS AS MANUFACTURED IN SAINT SULPICE, FRANCE. BENAZEPRIL HYDROCHLORIDE AS MANUFACTURED IN MARSA, MALTA. ACETAMINOPHEN, DC 90% AS MANUFACTURED IN SHANDONG PROVINCE, CHINA. BIODEGRADABLE POLYMER EXCIPIENTS AS MANUFACTURED IN BIRMINGHAM, AL. FP-059 (FOMEPIZOLE) DRUG SUBSTANCE AS MANUFACTURED IN GERMANTOWN, WI. PAROXETINE HYDROCHLORIDE (HEMIHYDRATE) USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. Page 571

4Q2012EXCEL DMF# 19153 19154 I 19155 19156 A 19157 19158 19159 A 19160 A 19161 19162 19163 I 19164 A 19165 19166 19167 19168 19169 19170 19171 A 19172 19173 19174 19175 I 19176 19177 19178 A 19179 19180 19181 19182 19183 19184 A A I A A A II II II II II IV 2/14/2006 8/7/2006 3/9/2006 5/18/2006 2/17/2006 2/10/2006 DR REDDYS LABORATORIES LTD CIPLA LTD CIPLA LTD CIPLA LTD CIPLA LTD BASF SE A A II II II 2/14/2006 2/10/2006 2/14/2006 ALCHYMARS ICM SM PRIVATE LTD CAMBREX KARLSKOGA AB SUN PHARMACEUTICAL INDUSTRIES LTD I I I IV IV IV IV 2/14/2006 2/14/2006 2/14/2006 2/14/2006 FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC A A A A A A IV III II II II II II 10/20/2005 2/10/2006 2/8/2006 2/10/2006 2/9/2006 2/13/2006 3/15/2006 SASOL GERMANY GMBH GRAHAM PACKAGING CO LP ACS DOBFAR SPA CADILA HEALTHCARE LTD EXCELLA GMBH CAMBRIDGE MAJOR LABS INC MERCK SHARP AND DOHME CORP V 12/23/2005 DEVELOPMENT CENTER BIOTECHNOLOGY A A II II II 2/8/2006 2/8/2006 2/8/2006 II 2/2/2006 A I II II II 2/6/2006 2/3/2006 1/30/2006 NEKTAR THERAPEUTICS LIMTECH CARBONATE INC A II III 1/19/2006 2/4/2006 CADILA PHARMACEUTICALS LTD P CHHOTALAL MANUFACTURERS EXPORTERS STATUS Type SUBMIT DATE A II III 1/30/2006 1/31/2006 HOLDER AUROBINDO PHARMA LTD NYPRO INC SUBJECT

4Q2012

BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CONTAINER CLOSURE SYSTEM OF THE DRY POWDER INHALER (DPI) AS MANUFACTURED IN CLINTON, MA FOR NYPRO INC CELECOXIB (ESUB) AS MANUFACTURED IN GUJARAT, INDIA. PLASTIC BOTTLES (MADE OF HDPE, LDPE, MDPE & PP) ALUMINUM COLLAPSIBLE TUBES, ALUMINUM AEROSOL CANS, ALUMINUM PHARMACEUTICAL FOIL AND POLYAL TAPE AS MANUFACTURED IN DAMAN, INDIA. PEG2NHS40KP/B (MODIFIED LYSINE) AS MANUFACTURED IN HUNTSVILLE, AL. LITHIUM CARBONATE, USP GRADE AS MANUFACTURED IN QUEBEC, CANADA.

CHONGQING UNITED PHARMACEUTICAL CO PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, CHINA. LTD FERMION OY QUETIAPINE FUMARATE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN ESPOO, FINLAND. SUN PHARMACEUTICAL INDUSTRIES LTD CARISOPRODOL USP (ACTIVE SUBSTANCE) AS MANUFACTURED IN GUJARAT, INDIA. SUN PHARMACEUTICAL INDUSTRIES LTD NIPPON CHEMIPHAR CO LTD CEPHALEXIN USP (ACTIVE SUBSTANCE) AS MANUFACTURED IN GUJARAT, INDIA. NC-2300 DRUG SUBSTANCE AS MANUFACTURED IN IWATE, JAPAN FOR NIPPON CHEMIPHAR CO LTD CGMP MANUFACTURING FACILITY FOR PRODUCTION OF BIOPHARMACEUTICALS FOR CLINICAL TRIALS, TAIWAN R.O.C. LIPOXOL(R) MED AS MANUFACTURED IN MARL, FEDERAL REPUBLIC OF GERMANY. PLASTIC CONTAINERS AS MANUFACTURED IN HARRISONBURG, VA. ACID CEFOTETAN AS MANUFACTURED IN MILANO, ITALY. OLANZAPINE AS MANUFACTURED IN GUJARAT, INDIA. ADAPALENE (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY LETROZOLE, USP AS MANUFACTURED IN GERMANTOWN, WI. RSD1235 DRUG SUBSTANCE (ESUB) AS MANUFACTURED BY MERCK EPROVA AG IN SCHAFFHAUSEN, SWITZERLAND FOR CARDIOME PHARMA CORP. 805.124 N-C ARTIFICIAL BANANA FLAVOR AS MANUFACTURED IN GENEVA, IL. 936.420 MASKING AGENT FLAVOR, ARTIFICIAL AS MANUFACTURED IN GENEVA, IL. 875.017 MENTHOL FLAVOR, NATURAL AS MANUFACTURED IN GENEVA, IL. 915.010 N-C ARTIFICIAL FRESH STRAWBERRY FLAVOR AS MANUFACTURED IN GENEVA, IL. CLINDAMYCIN HYDROCHLORIDE, USP AS MANUFACTURED IN TAMIL NADU, INDIA. BUPIVACAINE BASE AS MANUFACTURED IN KARLSKOGA, SWEDEN. PAROXETINE HYDROCHLORIDE HEMIHYDRATE USP AS MANUFACTURED IN GUJARAT, INDIA. RIZATRIPTAN BENZOATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ALFUZOSIN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. FAMCICLOVIR (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. DESLORATADINE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. LEVO SALBUTAMOL SULPHATE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA KOLLICOAT(R) PROTECT AS MANUFACTURED IN LUDWIGSHAFEN AND OFFENBURG, GERMANY FOR BASF AKTIENGESELLSCHAFT.

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4Q2012EXCEL DMF# 19185 I 19186 19187 19188 19189 19190 19191 A 19192 A 19193 A 19194 I 19195 19196 I 19197 I 19198 19199 A 19200 19201 19202 A 19203 19204 A 19205 I 19206 19207 19208 19209 A 19210 I 19211 A 19212 19213 I A II II 3/3/2006 2/23/2006 NATCO PHARMA LTD ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD SUMATRIPTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA. II 2/27/2006 SYNTHON BV III 3/2/2006 I A I V II III II 2/16/2006 2/28/2006 11/7/2005 2/10/2006 CATALENT PHARMA SOLUTIONS LLC AUSTIN PHARMA LLC HEINKE TECHNOLOGY INC SHANDONG WEIFANG PHARMACEUTICAL FACTORY CO LTD LG CHEM LTD II 2/24/2006 MDS NORDION A II III 2/14/2006 2/6/2006 IND SWIFT LABORATORIES LTD ANSA PRINTPACK PVT LTD N N II 2/21/2006 NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER MYLAN LABORATORIES LTD A II III 2/22/2006 2/23/2006 PCAS FPC FLEXIBLE PACKAGING CORP II 2/21/2006 EXCELLA GMBH A II III 2/23/2006 2/20/2006 II 2/21/2006 HEBEI CHANGSHAN BIOCHEMICAL & PHARMACEUTICAL CO LTD ARCH PHARMALABS LTD BESPAK DIV CONSORT MEDICAL PLC IV 2/15/2006 KERRY INGREDIENTS AND FLAVOURS II 2/21/2006 A I I I A II III III III II II 1/31/2006 2/10/2006 2/10/2006 2/10/2006 2/17/2006 10/25/2005 AUROBINDO PHARMA LTD FARMASERVICE SRL FARMASERVICE SRL FARMASERVICE SRL WEIFA AS JIANGXI HENGXIANG PHARMACEUTICAL TECHNOLOGY CO LTD DR REDDYS LABORATORIES LTD STATUS Type SUBMIT DATE II 2/8/2006 HOLDER EXOPHARM CO LTD SUBJECT

4Q2012

IDARUBICIN HYDROCHLORIDE, USP NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN SHANGHAI, CHINA FOR EXOPHARM CO LTD RABEPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA. SQUARE HDPE BOTTLE, 95 ML AS MANUFACTURED IN SERMONETA, ITALY. SQUARE HDPE BOTTLE, 25 ML AS MANUFACTURED IN SERMONETA, ITALY. SQUARE HDPE BOTTLE, 165 ML AS MANUFACTURED IN SERMONETA, ITALY. METFORMIN HYDROCHLORIDE AS MANUFACTURED IN SANNIDAL, NORWAY. ISOTRETINOIN (NON-STERILE BULK FORM) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. ESOMEPRAZOLE MAGNESIUM (AMORPHOUS FORM) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. NATURAL SPEARMINT FLAVOR WONF (080-00707) POWDER AS MANUFACTURED IN CINCINNATI, OH. HEPARIN SODIUM USP AS MANUFACTURED IN HEBEI, CHINA. MEFENAMIC ACID, USP AS MANUFACTURED IN MAHARASHTRA, INDIA. BK357933MTA PHARMACEUTICAL METERING VALVE AS MANUFACTURED IN NORFOLK, U.K. HALOPERIDOL DECANOATE AS MANUFACTURED IN FEUCHT, FEDERAL REPUBLIC OF GERMANY. ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN TURKU, FINLAND. PHARMACEUTICAL POUCH - FPC SPECIFICATION 47515X AS MANUFACTURED IN ONTARIO, CANADA.

FORMOTEROL FUMARATE DIHYDRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA. ARIPIPRAZOLE AS MANUFACTURED IN PUNJAB, INDIA. ALUMINIUM FOIL & PAPER LAMINATES -POLYLAMINATED & HEAT SEAL LACQUER (HSL) COATED FOR PACKING TABLETS, CAPSULES AND OTHER SOLID DOSAGE FORMS AS MANUFACTURED IN MAHARASHTRA, INDIA. IODOFILTIC ACID I-123 STERILE INJECTION AS MANUFACTURED IN VANCOUVER, CANADA. CARDINAL HEALTH'S STERILE MANUFACTURING FACILITIES IN SAN DIEGO, CA. DRONABINOL USP AS MANUFACTURED IN ROUND ROCK, TX. A MEASURING SPOON AS MANUFACTURED IN LINCOLN, NE. HYDRALAZINE HYDROCHLORIDE (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA. ABS PRODUCTS INTENDED FOR USE IN DRUG PACKAGING APPLICATIONS AS MANUFACTURED IN SEOUL, KOREA. ANASTROLZOLE AS MANUFACTURED IN PRAGUE, CZECH REPUBLIC FOR SYNTHON BV

RIBAVIRIN (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN ZHEJIANG, CHINA. Page 573

4Q2012EXCEL DMF# 19214 19215 19216 19217 A 19218 19219 19220 19221 A 19222 A 19223 19224 19225 A 19226 19227 19228 19229 19230 19231 19232 I 19233 I 19234 A 19235 19236 19237 A 19238 19239 A 19240 A 19241 I 19242 A 19243 A II 3/7/2006 II 3/8/2006 JOHNSON MATTHEY PHARMACEUTICAL MATERIALS ERREGIERRE SPA III 12/19/2005 HEINKE TECHNOLOGY INC III 3/10/2006 TOYO INK MFG CO LTD A II III 2/28/2006 3/9/2006 A A V II II 9/23/2005 3/10/2006 3/8/2006 TERUMO BCT LTD CADILA HEALTHCARE LTD BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI SPA AUROBINDO PHARMA LTD COLORS FOR PLASTICS III 3/1/2006 POLYONE CORP III 2/24/2006 CHITINOR AS A A I I I A II II II II V II III 2/28/2006 2/28/2006 2/25/2006 3/3/2006 3/13/2005 3/7/2006 2/24/2006 AUROBINDO PHARMA LTD LUPIN LTD IONS PHARMA FLAMMA SPA STERIS ISOMEDIX SERVICES CONCORD BIOTECH LTD COGNIS DEUTSCHLAND GMBH CO KG A A II II II 2/18/2006 3/3/2006 3/4/2006 IND SWIFT LABORATORIES LTD CADILA HEALTHCARE LTD CADILA HEALTHCARE LTD II 3/6/2006 TERUMO CORP A N N IV 3/3/2006 II 2/28/2006 STATUS Type SUBMIT DATE I A A II II II II 3/2/2006 3/3/2006 1/19/2006 3/1/2006 HOLDER NARD CHEMICALS LTD NATCO PHARMA LTD CADILA PHARMACEUTICALS LTD ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTD LUPIN LTD NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER YKF INC SUBJECT SON-216 API AS MANUFACTURED IN OSAKA, JAPAN.

4Q2012

GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. MELOXICAM AS MANUFACTURED IN GUJARAT, INDIA. LOVASTATIN USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. CARVEDILOL (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA.

SYNTHETIC AMORPHOUS SILICA PRODUCTS - SYLYSIA / ADSOLIDER AS MANUFACTURED IN AICHI, JAPAN. IHL- 305 IRINOTECAN LIPOSOME INJECTION AS MANUFACTURED IN HYOGO, JAPAN FOR TERUMO CORP CLARITHROMYCIN SPECIAL AS MANUFACTURED IN PUNJAB, INDIA. ZOLPIDEM TARTRATE AS MANUFACTURED IN GUJARAT, INDIA. CLINDAMYCIN HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA FOR PHARMADEV LLC AMPICILLIN TRIHYDRATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. PANTOPRAZOLE SODIUM SESQUIHYDRATE (ESUB) METFORMIN HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA. LANSOPRAZOLE AS MANUFACTURED IN BERGAMO, ITALY. STERIS INC ISOMEDIX SERVICES FACILITY IN NOGALES, AZ. MYCOPHENOLATE MOFETIL AS MANUFACTURED IN AHMEDABAD, INDIA. SPEZIOL G 86% PF AS MANUFACTURED BY COGNIS OLEOCHEMICALS IN DUSSELDOLF, FEDERAL REPUBLIC OF GERMANY FOR COGNIS DEUTSCHLAND GMBH CO KG. SPEZIOL G 99,8% PF AS MANUFACTURED IN DUSSELDOLF, FEDERAL REPUBLIC OF GERMANY FOR COGNIS DEUTSCHLAND GMBH CO KG CC10047660BG COLORANT PRODUCT AS MANUFACTURED IN NAVARRA, SPAIN FOR POLYONE CORP GAMBRO MANUFACTURING FACILITY IN ANTRIM, NORTHERN IRELAND. GLYBURIDE AS MANUFACTURED IN GUJARAT, INDIA. TORSEMIDE (MOD 1) BULK SUBSTANCE AS MANUFACTURED IN FRESONARA, ITALY. OXACILLIN SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. THERMOPLASTIC RESIN COLORANT MASTERBATCHES E14070, E14071, AND W07769 AS MANUFACTURED IN ELK GROVE VILLAGE, IL AND SPARTANBURG, SC. MF357PTPHS VARNISH AND 790PTPOP VARNISH AS MANUFCTURED IN KAWAGOE-SHI SAITAMA, JAPAN. SKIN TAG (ACROCHORDON) REMOVAL DEVICE TAGNER AS MANUFACTURED IN LINCOLN, NE. ALENDRONIC ACID MONOHYDRATE (ALC) AS MANUFACTURED IN CONSHOHOCKEN, PAN. NABUMETONE PH. EUR. AS MANUFACTURED IN BERGAMO, ITALY.

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4Q2012EXCEL DMF# 19244 A 19245 A 19246 A 19247 19248 I 19249 19250 A 19251 19252 19253 19254 I 19255 A 19256 19257 A 19258 I 19259 I 19260 19261 19262 I 19263 I 19264 A 19265 19266 19267 19268 A 19269 A 19270 19271 A A II III 3/22/2006 3/20/2006 AMRI RENSSELAER INC CREATIVE TECHNOPLAST II 3/20/2006 ENDORECHERCHE INC A A A II II II II 3/15/2006 3/18/2006 3/16/2006 3/21/2006 AUROBINDO PHARMA LTD SUVEN LIFE SCIENCES LTD LUPIN LTD TEVA PHARMACEUTICAL INDUSTRIES LTD IV 3/14/2006 DAH FENG CAPSULE INDUSTRY CO LTD III 3/13/2006 COPE ALLMAN JAYCARE LTD A A II II II 3/14/2006 4/18/2006 3/14/2006 II 2/6/2006 II 2/6/2006 XI'AN HUIFENG BIOCHEMISTRY GROUP CO LTD XI'AN HUIFENG BIOCHEMISTRY GROUP CO LTD ALCHEM INTERNATIONAL LTD IPCA LABORATORIES LTD CHEMISCHE FABRIK BERG GMBH A III II 3/14/2006 3/17/2006 OKADA SHIGYO CO LTD CSL BEHRING GMBH III 3/15/2006 A A A II III II II 3/16/2006 3/1/2006 1/3/2006 3/8/2006 SUN PHARMACEUTICAL INDUSTRIES LTD KEY INTERNATIONAL INC CADILA PHARMACEUTICALS LTD I II II 3/8/2006 3/10/2006 OCEAN NUTRITION CANADA LTD USV LIMITED A II III 3/4/2006 3/7/2006 AUROBINDO PHARMA LTD MATRIX TOOL INC IV 1/20/2006 IV 1/20/2006 BASF PERSONAL CARE AND NUTRITION GMBH COGNIS GMBH STATUS Type SUBMIT DATE IV 1/20/2006 HOLDER CHITINOR AS SUBJECT CHITOPHARM L AS MANUFACTURED IN TROMSOE, NORWAY FOR COGNIS DEUTSCHLAND GMBH CO KG CHITOPHARM M AS MANUFACTURED IN TROMSOE, NORWAY FOR COGNIS DEUTSCHLAND GMBH CO KG CHITOPHARM S AS MANUFACTURED IN TROMSOE, NORWAY FOR COGNIS DEUTSCHLAND GMBH CO KG TOPIRAMATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

4Q2012

APPLICATOR STICK (PLASTIC INJECTION MOLDED COMPONENT) AS MANUFACTURED IN FAIRVIEW, PA. 18/12 TG COMPLEX CAPSULES AS MANUFACTURED IN NOVA SCOTIA, CANADA. PIOGLITAZONE HYDROCHLORIDE (EXTRA PURE) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ESCITALOPRAM OXALATE AS MANUFACTURED IN GUJARAT, INDIA. PVC/PVDC/PE LAMINATED FILM AS MANUFACTURED IN ENGLISHTOWN, NJ. CHLORHEXIDINE BASE AS MANUFACTURED IN GUJARAT, INDIA.

YANGTZE RIVER PHARMACY GROUP LANSOPRAZOLE, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU JIANGSU HAI CI BIOLOGICAL PHARMACY CO PROVINCE, CHINA. LTD CORMACK PACKAGING PTY LTD CORMACK TECR-PP (3 PIECE TAMPER EVIDENT CHILD RESISTANT CLOSURE FOR PILFER PROOF NECK FINISH, 28 MM) AS MANUFACTURED IN NEW SOUTH WALES, AUSTRALIA. HI-GALFILM, HI-COAT K TYPE AS MANUFACTURED IN OSAKA, JAPAN. STERILE WATER FOR INJECTION (DILUENT) AS MANUFACTURED IN MARBURG, GERMANY. TROXERUTIN, NON-STERILE BULK FORM AS MANUFACTURED IN SHAANXI PROVINCE, CHINA FOR XI'AN HUIFENG BIOCHEMISTRY GROUP CO LTD DIOSMIN, NON-STERILE BULK FORM AS MANUFACTURED IN SHAANXI PROVINCE, CHINA FOR XI'AN HUIFENG BIOCHEMISTRY GROUP CO. LTD. 10 DEACETYL BACCATIN III (10 DAB III) AS MANUFACTURED IN HARYANA, INDIA. MESALAMINE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA. PENTOBARBITAL SODIUM USP AS MANUFACTURED IN BITTERFELD, FEDERAL REPUBLIC OF GERMANY. 60ML HDPE ROUND PACKER AS MANUFACTURED IN NEWCASTLE UPON TYNE, UNITED KINGDOM. EMPTY HARD SHELL VEGETABLE CAPSULES (HYDROXYPROPYL METHYL CELLULOSE) AS MANUFACTURED IN TAICHUNG, TAIWAN R.O.C. PIPERACILLIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. DIVALPROEX SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA. RISPERIDONE AS MANUFACTURED IN MAHARASHTRA, INDIA. LORAZEPAM AS MANUFACTURED IN BE'ER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD ACOLBIFENE, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN ONTARIO, CANADA. SGD-1006 (VC-MMAE) INTERMEDIATE AS MANUFACTURED IN RENSSELAER, NY. HDPE BOTTLE FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN DAMAN UNION TERRITORY, INDIA.

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4Q2012EXCEL DMF# 19272 19273 19274 19275 A 19276 19277 19278 19279 I 19280 A 19281 19282 19283 19284 I 19285 19286 A 19287 19288 19289 19290 19291 I 19292 19293 19294 19295 19296 C 19297 19298 19299 19300 A 19301 19302 19303 A 19304 A IV 4/4/2006 LYNE LABORATORIES INC A A II III III 3/27/2006 3/28/2006 11/17/2004 LUPIN LTD REXAM HEALTHCARE OFFRANVILLE SAS SFB PLASTICS INC A A A II IV II III 3/28/2006 3/28/2006 3/27/2006 3/6/2006 CADILA HEALTHCARE LTD GATTEFOSSE SAS LUPIN LTD ADHESIVES RESEARCH INC N A N A II II 3/20/2006 3/24/2006 II 3/24/2006 NOT AN ASSIGNED NUMBER SHANGHAI JINSHAN BIOTECH CO LTD NOT AN ASSIGNED NUMBER LUPIN LTD TEVA PHARMACEUTICAL INDUSTRIES LTD LOSARTAN POTASSIUM (AMORPHOUS) (ESUB) PACLITAXEL AS MANUFACTURED IN SHANGHAI, CHINA. N A A A II II II II 2/27/2006 2/27/2006 3/21/2006 3/24/2006 NOT AN ASSIGNED NUMBER WOCKHARDT LTD WOCKHARDT LTD LUPIN LTD PHARMACIA AND UPJOHN SUB PFIZER INC A III II 3/15/2006 3/24/2006 A A A II II II II 3/17/2006 3/24/2006 3/21/2006 3/8/2006 AUROBINDO PHARMA LTD NEULAND LABORATORIES LTD AUROBINDO PHARMA LTD III 3/21/2006 ADIT INDUSTRIES A A A IV IV IV II 3/20/2006 3/20/2006 3/20/2006 3/16/2006 UNGERER AND CO UNGERER AND CO UNGERER AND CO SHANDONG FREDA BIOCHEM CO LTD N/A BLUEBERRY FLAVOR FM-4726 AS MANUFACTURED IN BETHLEHEM, PA. N/A STRAWBERRY FLAVOR FN-2356 AS MANUFACTURED IN BETHLEHEM, PA. N/A GRAPE FLAVOR FM-2727 AS MANUFACTURED IN BETHLEHEM, PA. STATUS Type SUBMIT DATE A A N IV 3/20/2006 II II 3/23/2006 1/23/2006 HOLDER UNIMARK REMEDIES LTD GLOCHEM INDUSTRIES LTD NOT AN ASSIGNED NUMBER UNGERER AND CO SUBJECT FLECAINIDE ACETATE USP AS MANUFACTURED IN GUJARAT, INDIA.

4Q2012

CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ARTIFICIAL BITTER MASKING FLAVOR FM-4730 AS MANUFACTURED IN BETHLEHEM, PA.

SODIUM HYALURONATE (NON-STERILE BULK FORM) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA. NEUTRAL GLASS AMPOULES AND VIALS USP (TYPE 1) AS MANUFACTURED IN SARIGAM, INDIA. METOPROLOL SUCCINATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. OLANZAPINE FORM-1 AS MANUFACTURED IN ANDHRA PRADESH, INDIA. METOPROLOL TARTRATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

YANGTZE RIVER PHARMACY GROUP TAMOXIFEN CITRATE USP AS MANUFACTURED IN JIANGSU PROVINCE, CHINA. JIANGSU HAI CI BIOLOGICAL PHARMACY CO LTD GENESIS INDUSTRIES INC USV LIMITED PACKAGING MATERIAL AS MANUFACTURED IN ELMWOOD, WI. DONEPEZIL HYDROCHLORIDE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN MAHARASHTRA, INDIA. CLOPIDOGREL BISULFATE USP (FORM-1) AS MANUFACTURED IN GUJARAT, INDIA. ZOLPIDEM TARTRATE AS MANUFACTURED IN GUJARAT AND MAHARASHTRA, INDIA. CEFADROXIL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA. TRIAMCINOLONE 5 DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN KALAMAZOO, MI.

FLUVASTATIN SODIUM AS MANUFACTURED IN BE'ER SHEVA, ISRAEL AND U.P., INDIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD. BUPROPION HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA. EMULFREE(R) P PHARMA AS MANUFACTURED IN SAINT PRIEST, FRANCE. ALENDRONATE SODIUM USP (ESUB) AS-131 ADHESIVE AS MANUFACTURED IN LIMERICK, IRELAND AND GLEN ROCK, PA FOR ADHESIVES RESEARCH, INC. VALSARTAN (ESUB) PILLJARS BI (80 ML & 120 ML) AS MANUFACTURED IN OFFRANVILLE, FRANCE. CONTAINERS FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN WICHITA, KS. PLASTIGEL 5 (PLASTICIZED HYDROCARBON GEL) (ESUB) AS MANUFACTURED IN BROCKTON, MA. Page 576

4Q2012EXCEL DMF# 19305 19306 19307 19308 19309 19310 19311 I 19312 19313 19314 19315 19316 19317 19318 19319 19320 19321 19322 19323 A 19324 19325 19326 19327 19328 19329 I 19330 19331 I 19332 A 19333 I 19334 19335 19336 A 19337 A 19338 A II 3/31/2006 AUROBINDO PHARMA LTD II 4/4/2006 ANTIBIOTICOS DO BRASIL LTDA A A II II II 4/6/2006 4/7/2006 4/7/2006 BCN PEPTIDES RHODES TECHNOLOGIES SUVEN LIFE SCIENCES LTD II 4/5/2006 LIPOID GMBH III 4/7/2006 BESPAK DIV CONSORT MEDICAL PLC A II II 3/31/2006 4/7/2006 AUROBINDO PHARMA LTD SPI PHARMA INC A A A I N II 4/4/2006 II II II II 3/31/2006 3/30/2006 3/31/2006 4/6/2006 LUPIN LTD LUPIN LTD LUPIN LTD NV ORGANON NOT AN ASSIGNED NUMBER SANMAR SPECIALTY CHEMICALS LTD A N N N N N N N N N N IV 3/28/2006 II 3/30/2006 SHISEIDO CO LTD NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER SAFC PHARMA STATUS Type SUBMIT DATE I A A A A A III III II II II II II 3/20/2006 3/29/2006 3/28/2006 3/27/2006 3/2/2007 3/9/2006 3/31/2006 HOLDER POLIMERI EUROPA FRANCE POLYONE CORP NECTAR LIFESCIENCES LTD AUROBINDO PHARMA LTD CIPLA LTD ESTEVE QUIMICA SA SUMITOMO CHEMICAL CO LTD SUBJECT FLEXIRENE MT40 AS MANUFACTURED IN MARDYCK, FRANCE. CC10075538WE AS MANUFACTURED IN ELK GROVE VILLAGE, IL. CEFIXIME USP AS MANUFACTURED IN PUNJAB, INDIA. FINASTERIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

4Q2012

MITOXANTRONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN BANGALORE INDIA LANSOPRAZOLE AS MANUFACTURED IN GIRONA, SPAIN. BICALUTAMIDE DRUG SUBSTANCE AS MANUFACTURED IN OSAKA CITY AND GIFU PREFECTURE, JAPAN. SALAMANDER 300 AS MANUFACTURED IN SHIZUOKA, JAPAN.

OLEYLAMINE, PURIFIED (AN EXCIPIENT) AS MANUFACTURED IN DORSET, UNITED KINGDOM. TOLTERODINE TARTRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. TOPIRAMATE (ESUB) AZITHROMYCIN MONOHYDRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA. NORGESTIMATE AS MANUFACTURED IN OSS, THE NETHERLANDS. NISOLDIPINE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN TAMIL NADU, INDIA. SUMATRIPTAN SUCCINATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. BARCROFT(TM) 5300D MAGNESIUM HYDROXIDE USP AS MANUFACTURED IN LEWES, DE. BK357978MTA PHARMACEUTICAL METERING VALVE AS MANUFACTURED IN NORFOLK, UNITED KINGDOM. LIPOID S 100 E AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY. DESMOPRESSIN ACETATE AS MANUFACTURED IN BARCELONA, SPAIN. DRONABINOL, 10% IN SESAME OIL AS MANUFACTURED IN COVENTRY, RI. 2-(2-ETHOXY PHENOXY) ETHYL BROMIDE - DRUG INTERMEDIATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CEFTRIAXONE SODIUM USP (STERILE BULK) AS MANUFACTURED IN COSMOPOLIS, BRASIL. 6-AMINO PENICILLANIC ACID DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

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4Q2012EXCEL DMF# 19339 A 19340 A 19341 A 19342 19343 19344 A 19345 19346 19347 19348 A 19349 I 19350 19351 A 19352 A 19353 A 19354 19355 19356 19357 19358 19359 19360 19361 19362 19363 A A I A A A A A A IV IV II III IV IV IV IV II IV 4/14/2006 4/14/2006 4/3/2006 4/12/2006 4/12/2006 4/12/2006 4/12/2006 4/12/2006 4/8/2006 4/14/2006 CAFOSA GUM SA CAFOSA GUM SA PCAS HEINKE TECHNOLOGY INC UNGERER AND CO UNGERER AND CO UNGERER AND CO UNGERER AND CO SECOND PHARMA CO LTD EVONIK DEGUSSA CORP CAFOSA 257 CLASSIC AS MANUFACTURED IN BARBERA DEL VALLES, SPAIN. CAFOSA 258 SOFT AS MANUFACTURED IN BARBERA DEL VALLES, SPAIN. IV 4/14/2006 CAFOSA GUM SA III 4/6/2006 SCHOTT KAISHA PVT LTD A II III 4/12/2006 4/6/2006 CHEMPACIFIC CORP SCHOTT KAISHA PVT LTD II 4/12/2006 ARDANA BIOSCIENCE LTD A A A III IV II IV 4/11/2006 4/7/2006 4/10/2006 4/3/2006 BARALAN INTERNATIONAL SPA STEPAN CO CHEMAGIS LTD CRODA INC C A II II III 4/11/2006 4/4/2006 4/11/2006 TEVA PHARMACEUTICAL INDUSTRIES LTD ERREGIERRE SPA BARALAN INTERNATIONAL SPA AZTREONAM USP AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO. PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN BERGAMO, ITALY. III 4/3/2006 II 4/11/2006 STATUS Type SUBMIT DATE II 4/11/2006 HOLDER ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD PRAVESHA INDUSTRIES PRIVATE LTD SUBJECT DESLORATADINE AS MANUFACTURED IN MAHARASHTRA, INDIA. SUMATRIPTAN SUCCINATE AS MANUFACTURED IN MAHARASHTRA, INDIA.

4Q2012

HIGH DENSITY POLYETHYLENE CONTAINERS (40CC, 60CC, 75CC, 100CC, 120CC, 200CC, 250CC, 500CC, 850CC & 75CCHW) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

PLASTIC CAPS, PLASTIC RODS AND NYLON BRUSHES AS MANUFACTURED BY LABOR PLAST S.R.L. AND SORINI & MIGLIAVACCA S.P.A. IN MILAN, ITALY; DUPONT FILAMENTS IN LANDGRAAF, THE NETHERLANDS. GLASS BOTTLES AS MANUFACTURED IN PARMA, ITALY. ONAMER(R) M, POLYQUATERNIUM-1 AS MANUFACTURED IN MAYWOOD, NJ. TEMOZOLOMIDE AS MANUFACTURED IN BEER SHEVA, ISRAEL. SUPER REFINED POLYETHYLENE GLYCOL 400 NF AS MANUFACTURED IN MILL HALL, PA. TESTOSTERONE CREAM 1% (ARD-0403) AS MANUFACTURED BY INSTITUTE DE DEVELOPPEMENT DE PRODUITS DE SANTE) IN ARTIGUES PRES BORDEAUX, FRANCE. METHOXSALEN DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE, MD. NON-STERILE GLASS BARRELS (SYRINGES) AS MANUFACTURED IN NANI DAMAN, INDIA. SAFEPAC STERILE PRE-FILLABLE GLASS SYRINGE COMPONENTS AS MANUFACTURED IN NANI DAMAN, INDIA. DREYCO(R) CHEWING GUM BASE AS MANUFACTURED IN BARBERA DEL VALLES, SPAIN.

BISMUTH SUBSALICYLATE AS MANUFACTURED IN LA VOULTE SUR RHONE, FRANCE. COMFORT TIP VAGINAL CREAM APPLICATOR AS MANUFACTURED IN LINCOLN, NE. N/A BANANA FLAVOR WS FN-6713 AS MANUFACTURED IN BETHLEHEM, PA. N/ACITRUS FLAVOR FN-7176 AS MANUFACTURED IN BETHLEHEM, PA. N/A FRUIT FLAVOR FN-6714 AS MANUFACTURED IN BETHLEHEM, PA. N/A MASKER FLAVOR FN-6820 AS MANUFACTURED IN BETHLEHEM, PA. TERAZOSIN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. PRECIPITATED SILICA AS MFG BY DEGUSSA CORP (CHESTER, PA), DEGUSSA AG ( GERMANY),INSILCO LTD (INDIA),SILQUIMICA SA (SPAIN),UNITED SILICA IND LTD (TAIWAN),UNITED SILICA LTD ( THAILAND),EGESIL KIMYA SANAYI VE TICARET AS (TURKEY) & DSL(JAPAN). RELEASE LINER FILM FOR USE IN TRANSDERMAL DRUG DELIVERY PATCHES - FIM IN SHIZUOKA PREF., JAPAN. FOR FUJIMORI KOGYO CO LTD GRANISETRON HYDROCHLORIDE (NON-STERILE) AS MANUFACTURED IN HUBEI, CHINA. LABETALOL HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. OMEPRAZOLE MAGNESIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

A 19364 A 19365 19366 19367 A A A II II II 4/10/2006 4/14/2006 4/14/2006 HUBEI HAOSUN PHARMACEUTICAL CO LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD III 4/7/2006 FUJIMORI KOGYO CO LTD

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4Q2012EXCEL DMF# 19368 19369 19370 19371 A 19372 19373 I 19374 A 19375 A 19376 19377 A 19378 A 19379 19380 A 19381 A 19382 A 19383 19384 19385 19386 19387 19388 19389 19390 A 19391 A 19392 A 19393 A 19394 19395 A 19396 19397 A A II II 5/1/2006 4/29/2006 SIEGFRIED LTD SUVEN LIFE SCIENCES LTD I III III 4/7/2006 5/1/2006 RESPONSIVE POLYMERS LTD INEOS CHLORVINYLS BELGIUM NV III 4/25/2006 EMS CHEMIE NORTH AMERICA INC III 4/20/2006 TEKNOR COLOR CO III 4/24/2006 PETROMONT INC A A A A A A I II II II II II II IV II 4/20/2006 4/20/2006 3/1/2006 9/16/2005 4/18/2006 4/18/2006 4/10/2006 4/18/2006 TONIRA PHARMA LTD DR REDDYS LABORATORIES LTD WOCKHARDT LTD CADILA PHARMACEUTICALS LTD AUROBINDO PHARMA LTD AUROBINDO PHARMA LTD SPI PHARMA V 4/20/2006 PAIN THERAPEUTICS INC V 4/19/2006 PAIN THERAPEUTICS INC I II V 10/10/2005 4/18/2006 MATRIX LABORATORIES (XIAMEN) LIMITED PAIN THERAPEUTICS INC III 4/20/2006 STREAM PEAK INTERNATIONAL PTE LTD A II III 4/19/2006 4/20/2006 III 4/15/2006 III 4/15/2006 A II II 4/19/2006 4/18/2006 SUN PHARMACEUTICAL INDUSTRIES LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD JEEVANLAKSHMI PACKAGING SOLUTIONS PVT LTD JEEVANLAKSHMI PACKAGING SOLUTIONS PVT LTD DUPONT CHEMOSWED STREAM PEAK INTERNATIONAL PTE LTD STATUS Type SUBMIT DATE A A I II II II V 4/14/2006 4/14/2006 4/7/2006 4/17/2006 HOLDER MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD ERREGIERRE SPA PAIN THERAPEUTICS INC SUBJECT

4Q2012

NEVIRAPINE HEMIHYDRATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. MIRTAZAPINE ANHYDROUS USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. RISPERIDONE PH. EUR. AS MANUFACTURED IN BERGAMO, ITALY. REFERENCE INFORMATION TO SUPPORT THE SAFETY OF TRIACETIN (GLYCEROL TRIACETATE) USP, AS A PHARMACEUTICAL EXCIPIENT. SUMATRIPTAN SUCCINATE EP/BP AS MANUFACTURED IN GUJARAT, INDIA. CARVEDILOL AS MANUFACTURED IN MAHARASHTRA, INDIA. ROLL ON PILFER PROOF (ROPP) CAPS AS MANUFACTURED IN GOA, INDIA. COLLAPSIBLE ALUMINIUM TUBES AS MANUFACTURED IN GOA, INDIA. ISRADIPINE AS MANUFACTURED IN MALMO, SWEDEN. PERFORMANCE DRY DESICCANT PACKETS AS MANUFACTURED IN SINGAPORE AND SHANGHAI, CHINA FOR STREAM PEAK INTERNATIONAL PTE LTD. HUMI DRI DESICCANT PACKETS AS MANUFACTURED IN SINGAPORE AND SHANGHAI, CHINA FOR STREAM PEAK INTERNATIONAL PTE LTD. NEVIRAPINE USP, NON-STERILE BULK FORM AS MANUFACTURED IN FUJIAN, CHINA. REFERENCE INFORMATION TO SUPPORT THE SAFETY OF CELLULOSE ACETATE BUTYRATE 381-20BP AS A PHARMACEUTICAL EXCIPIENT. REFERENCE INFORMATION TO SUPPORT THE SAFETY OF ISOPROPYL MYRISTATE AS A PHARMACEUTICAL EXCIPIENT. REFERENCE INFORMATION TO SUPPORT THE SAFETY OF ETHYL LACTATE AS A PHARMACEUTICAL EXCIPIENT. FAMOTIDINE AS MANUFACTURED IN GUJARAT, INDIA. OLMESARTAN MEDOXOMIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ENTACAPONE AS MANUFACTURED IN GUJARAT, INDIA. VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA. LEVETIRACETAM DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CARISOPRODOL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. PHARMAGUM(TM) C AS MANUFACTURED IN GRAND HAVEN, MI.

ZHEJIANG HUAYI PHARMACEUTICAL CO LTD CLARITHROMYCIN AS MANUFACTURED IN ZHEJIANG, CHINA. HIGH DENSITY POLYETHYLENE RESINS HDPE 1000 AND HDPE 1002 AS MANUFACTURED IN QUEBEC, CANADA. COLOR CONCENTRATE 91,355HCTPE WHITE 50:1 AS MANUFACTURED IN HENDERSON, KY. GRIVORY HB 7103 NATURAL AS MANUFACTURED IN DOMAT/EMS, SWITZERLAND FOR EMS CHEMIE (NORTH AMERICA) INC PVC FILMS AS MANUFACTURED IN BOISAR, INDIA. MARVYLAN S 7102 PVC RESIN AS MANUFACTURED IN BEEK, THE NETHERLANDS FOR LIMBURGSE VINYL MAATSCHAPPIJ NV OXYCODONE HYDROCHLORIDE USP AS MANUFACTURED IN PENNSVILLE, NJ. (R)-(-)-5-(2-AMINOPROPYL)-2-METHOXYBENZENE SULPHONAMIDE HYDROCHLORIDE DRUG INTERMEDIATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. Page 579

4Q2012EXCEL DMF# 19398 19399 I 19400 19401 A 19402 19403 A 19404 A 19405 19406 I 19407 A 19408 19409 19410 19411 19412 19413 19414 A 19415 19416 A 19417 19418 19419 A 19420 A 19421 19422 19423 19424 A A I II II II IV 5/8/2006 5/5/2006 5/8/2006 4/27/2006 II 5/8/2006 A A II V II 5/9/2006 5/5/2006 4/28/2006 A II II 5/9/2006 5/9/2006 FORMOSA LABORATORIES INC MALLADI DRUGS AND PHARMACEUTICALS LTD URQUIMA SA DAIKYO SEIKO LTD A A A I I A II II II II III II III 5/5/2006 4/29/2006 4/21/2006 4/26/2006 5/3/2006 5/8/2006 5/5/2006 ISOCHEM SAS AUROBINDO PHARMA LTD COSMA SPA ERCROS INDUSTRIAL SA FYSE M AND H PLASTICS AARTI INDUSTRIES LTD 3M DRUG DELIVERY SYSTEMS II 6/13/2006 I IV IV 4/25/2006 4/25/2006 II 5/1/2006 A II II 4/20/2006 5/2/2006 A II II 5/2/2006 5/2/2006 GLENMARK GENERICS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD SYMBIOTEC PHARMALAB LTD TEVA PHARMACEUTICAL INDUSTRIES LTD LORATADINE AS MANUFACTURED IN GUJARAT, INDIA. CEFDINIR FORM-B AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA. HALOBETASOL PROPIONATE AS MANUFACTURED IN INDORE, INDIA. STATUS Type SUBMIT DATE A II II 4/26/2006 5/1/2006 HOLDER AUROBINDO PHARMA LTD SANDOZ INDUSTRIAL PRODUCTS SPA SUBJECT

4Q2012

ZALEPLON DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. LOVASTATIN DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN TRENTO, ITALY.

DESLORATADINE AS MANUFACTURED IN NETANYA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD BIOCON LTD ROSIGLITAZONE MALEATE DRUG SUBSTANCE AS MANUFACTURED IN BANGALORE, INDIA. HENRY H OTTENS MANUFACTURING CO INC NATURAL MINT FLAVOR #9295 AS MANUFACTURED IN PHILADELPHIA, PA. HENRY H OTTENS MANUFACTURING CO INC NATURAL PEPPERMINT FLAVOR EXTRACT #7801 AS MANUFACTURED IN PHILADELPHIA, PA. ZHEJIANG EXCEL PHARMACEUTICAL CO LTD GEMFIBROZIL (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. CARISOPRODOL AS MANUFACTURED IN VERT-LE-PETIT, FRANCE FOR ISOCHEM S.A. CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. BICALUTAMIDE (ESUB) AS MANUFACTURED IN BERGAMO, ITALY. COMPACTIN AS MANUFACTURED IN MADRID, SPAIN. PACKAGING MATERIAL AS MANUFACTURED IN WINCHESTER, VA AND SUFFOLK, U.K. QUINAPRIL HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA. SCOTCHPAK 9734, 2-MIL POLYESTER FILM LAMINATE AS MANUFACTURED IN COTTAGE GROVE, MN FOR 3M DRUG DELIVERY SYSTEMS CALCIPOTRIOL AS MANUFACTURED IN TAOYUAN, TAIWAN R.O.C. THREO-RITALINIC ACID AND SALT AS MANUFACTURED IN TAMIL NADU, INDIA. OLOPATADINE HYDROCHLORIDE AS MANUFACTURED IN BARCELONA, SPAIN. RSV COMPONENT WASHING PROCESS AT TOCHIGI, JAPAN.

SOUTHWEST SYNTHETIC PHARMACEUTICAL MECLIZINE HYDROCHLORIDE AS MANUFACTURED IN CHONGQING, CHINA. CO LTD HANZHONG HANJIANG VENTUREPHARM BUPROPION HYDROCHLORIDE (ESUB) AS MANUFACTURED BY HANJIANG PHARMACEUTICAL LTD PHARMACEUTICAL LTD IN SHAANXI PROVINCE, CHINA FOR HANZHONG HANJIANG VENTUREPHARM PHARMACEUTICAL LTD. BEIJING YI HE BIOTECH CO LTD EUTICALS SPA PCAS EVONIK DEGUSSA CORP PACLITAXEL USP, NON-STERILE BULK AS MANUFACTURED IN BEJING, CHINA. AZELASTINE HYDROCHLORIDE AS MANUFACTURED IN MILAN, ITALY. INDOCYANINE GREEN AS MANUFACTURED IN ARAMON, FRANCE FOR PCAS CALCIUM SILICATE AS MFG BY DEGUSSA CORP(CHESTER,PA);DEGUSSA AG(FEDERAL REPUBLIC OF GERMANY);INSILCO LTD (INDIA);SILQUIMICA SA(SPAIN);UNITED SILICA INDUSTRIAL LTD(TAIWAN);UNITED SILICA(THAILAND); EGESIL KIMYA SANAYI (TURKEY) & DEGUSSA SHIONOGI JAPAN CO (JAPAN). MOSAPRIDE CITRATE (NON-STERILE BULK FORM) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA.

I 19425 A II 4/20/2006 SHANDONG LUNAN BETTER PHARMACEUTICAL CO LTD

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4Q2012EXCEL DMF# 19426 A 19427 19428 19429 19430 A 19431 A 19432 19433 A 19434 19435 A 19436 A 19437 A 19438 A 19439 19440 19441 19442 A 19443 A 19444 A 19445 19446 19447 A 19448 A 19449 A 19450 A 19451 I 19452 A 19453 A IV 5/22/2006 COREL PHARMACHEM II 5/17/2006 CHEMCO PLUS SCIENTIFIC CO LTD II 5/22/2006 II 5/16/2006 II 5/16/2006 II 5/18/2006 ACTAVIS PHARMA MANUFACTURING PRIVATE LTD ZHEJIANG SUPOR PHARMACEUTICALS CO LTD ZHEJIANG SUPOR PHARMACEUTICALS CO LTD MITSUBISHI TANABE PHARMA CORP A A III II II 5/9/2006 5/12/2006 5/1/2006 ROY AND LECLAIR EMBALLAGE INC JUBILANT LIFE SCIENCES LTD PIRAMAL HEALTHCARE LTD II 3/20/2006 HEC PHARM CO LTD II 3/20/2006 HEC PHARM CO LTD A C A IV II II II 5/16/2006 5/16/2006 5/17/2006 3/10/2006 ACCUCAPS INDUSTRIES LTD AARTI DRUGS LTD DIVIS LABORATORIES LTD HEC PHARM CO II 5/12/2006 ISOTEC III 5/4/2006 FLEXTRUS AB III 5/4/2006 FLEXTRUS AB A II III 5/16/2006 5/4/2006 I II II 5/15/2006 5/10/2006 SINTENOVO SA DE CV ZHEJIANG XIANJU PHARMACEUTICAL CO LTD IBA MOLECULAR EASTERN ISOTOPES INC FLEXTRUS AB III 5/15/2006 WACKER CHEMICAL CORP A A A II II II IV 5/16/2006 5/12/2006 5/15/2006 5/5/2006 STATUS Type SUBMIT DATE II 5/12/2006 HOLDER HELSINN CHEMICALS SA HELSINN ADVANCED SYNTHESIS SA SUN PHARMACEUTICAL INDUSTRIES LTD GLENMARK GENERICS LTD GEDEON RICHTER PLC RELIANCE CELLULOSE PRODUCTS LTD SUBJECT SODIUM BENZOATE AS MANUFACTURED IN BIASCA, SWITZERLAND.

4Q2012

GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA. DESLORATADINE AS MANUFACTURED IN GUJARAT, INDIA. NORGESTIMATE AS MANUFACTURED IN DOROG, HUNGARY. CARBOXYMETHYLCELLULOSE SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. VINNOL(R) E 22/48 A AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR WACKER POLYMER SYSTEMS LP CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO. MEDROXYPROGESTERONE ACETATE USP, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG, CHINA IODINE-124 AS MANUFACTURED IN RICHMOND, VA. TRANSOFOIL EL-OPET/PELD LAMINATE, SPECIFICATION 2383150-0008 AS MANUFACTURED IN LUND, SWEDEN. TRANSOFOIL EL-OPET/PELD, SPECIFICATION 2383150-0008 AS MANUFACTURED IN LUND, SWEDEN. TRANSOFOIL EL-OPET/PE LAMINATE, MATERIAL SPECIFICATION M80142 AS MANUFACTURED IN LUND, SWEDEN. POTASSIUM PALMITATE-1,2,3,4-(13)C(4) FOR CLINICAL RESEARCH AS MANUFACTURED IN MIAMISBURG, OH. GELATIN MASS FOR SOFT GEL CAPSULES AS MANUFACTURED IN ONTARIO, CANADA. ZOLPIDEM TARTRATE AS MANUFACTURED IN MAHARASHTRA, INDIA. DESLORATADINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. METRONIDAZOLE USP, NON-STERILE BULK FORM AS MANUFACTURED IN HUBEI PROVINCE, CHINA. ERYTHROMYCIN THIOCYANATE, PHARMACEUTICAL INTERMEDIATE BULK FORM AS MANUFACTURED IN HUBEI PROVINCE, CHINA. ERYTHROMYCIN USP, NON-STERILE BULK FORM AS MANUFACTURED IN HUBEI PROVINCE, CHINA. ROPACKS (ROUND PACKER BOTTLES) AS MANUFACTURED IN QUEBEC, CANADA. ESCITALOPRAM OXALATE AS MANUFACTURED IN KARNATAKA, INDIA. OXYBUTYNIN CHLORIDE, BULK ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN ANDHRA PRADESH, INDIA. MOLINDONE HYDROCHLORIDE AS MANUFACTURED IN TAMILNADU, INDIA. FELODIPINE, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. SECNIDAZOLE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. Y-39983 DRUG SUBSTANCE AS MANUFACTURED IN FUKUI, JAPAN FOR MITSUBISHI TANABE PHARMA CORP LC-SORB SPW-C-ODS(S) - CHEMICALLY MODIFIED SILICA GEL AS MANUFACTURED IN OSAKA, JAPAN FOR CHEMCO SCIENTIFIC CO LTD ACRYCOAT, METHACRYLIC ACID COPOLYMER AS MANUFACTURED IN KADI, INDIA.

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4Q2012EXCEL DMF# 19454 A 19455 19456 19457 A 19458 19459 19460 19461 A 19462 A 19463 19464 A 19465 19466 A 19467 19468 19469 I 19470 I 19471 19472 19473 19474 I 19475 A 19476 19477 19478 A 19479 19480 19481 A 19482 19483 A A II III 5/30/2006 5/30/2006 PCAS 3M DRUG DELIVERY SYSTEMS A I II II II 5/31/2006 5/25/2006 5/31/2006 UNIMARK REMEDIES LTD ARCHIMICA SRL BASF SE A A II II II 5/26/2006 5/31/2006 5/26/2006 FARMAK AS FARMABIOS S P A AUROBINDO PHARMA LTD II 5/17/2006 I C A II II II II 4/15/2006 5/24/2006 5/26/2006 5/26/2006 DOSHION LIMITED APICORE LLC NOF CORP DSM NUTRITIONAL PRODUCTS LTD II 4/15/2006 DOSHION LIMITED A A II II II 5/19/2006 5/24/2006 4/15/2006 PEPTIDO GMBH RHODIA OPERATIONS DOSHION LIMITED A II II 5/22/2006 5/26/2006 INDUSTRIALE CHIMICA SRL JOHNSON MATTHEY INC MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN VARESE, ITALY. A II II 5/24/2006 5/22/2006 MEDICHEM MANUFACTURING MALTA LTD III 5/23/2006 BESPAK DIV CONSORT MEDICAL PLC A A A II III II II 5/19/2006 5/19/2006 5/26/2006 5/23/2006 A A II II II 5/25/2006 5/24/2006 5/23/2006 SUN PHARMACEUTICAL INDUSTRIES LTD DR REDDYS LABORATORIES LTD FOSPHENYTOIN SODIUM USP AS MANUFACTURED IN GUJARAT, INDIA. DESLORATADINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. STATUS Type SUBMIT DATE II 5/22/2006 HOLDER AUROBINDO PHARMA LTD SUBJECT

4Q2012

GEMFIBROZIL USP DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

JOHNSON MATTHEY INC PHARMACEUTICAL KETOPROFEN AS MANUFACTURED IN FLORENCE, ITALY. MATERIALS GROUP APOTEX PHARMACHEM INC LEVOFLOXACIN HEMIHYDRATE AS MANUFACTURED IN BRANTFORD, CANADA. 3M DRUG DELIVERY SYSTEMS SIEGFRIED USA LLC 3M DRUG DELIVERY SYSTEMS 3M COTRAN 9691 POLYESTER TAPE AS MANUFACTURED IN BROOKINGS, SD HYDROCODONE BITARTRATE USP AS MANUFACTURED IN PENNSVILLE, NJ. DROSPIRENONE/ETHINYL ESTRADIOL TRANSDERMAL DELIVERY SYSTEM AS MANUFACTURED IN ST. PAUL, MN. BK920 SERIES PHARMACEUTICAL ORAL ACTUATORS AND DUST CAPS AS MANUFACTURED IN NORFOLK, U.K. ZALEPLON (MED - 201970) AS MANUFACTURED IN HAL FAR, MALTA.

ST GOBAIN PERFORMANCE PLASTICS CORP SANIPURE(TM) 60 BIOPHARMACEUTICAL TUBING AS MANUFACTURED IN AKRON, OH.

OXANDROLONE AS MANUFACTURED IN WEST DEPTFORD, NJ; DEVENS, MA AND NORTH ANDOVER, MA. LIOTHYRONINE SODIUM AS MANUFACTURED IN BEXBACH, GERMANY. GADOLINIUM OXIDE AS MANUFACTURED IN LA ROCHELLE, FRANCE. P-544S - POTASSIUM SALT OF POLACRYLIC ACID WITH PERCENTAGE OF POTASSIUM TO EXTENT OF 17-20% AS MANUFACTURED IN GUJARAT, INDIA. P-544D - POTASSIUM SALT OF POLACRYLIC ACID WITH PERCENTAGE OF POTASSIUM TO EXTENT OF 24.5-25.5% AS MANUFACTURED IN GUJARAT, INDIA. P-542, SODIUM SALT OF POLACRYLIC ACID AS MANUFACTURED IN GUJARAT, INDIA. FOMEPIZOLE (ESUB) AS MANUFACTURED IN SOMERSET, NJ. PL-2000CS PHOSPHOLIPID COMPOUND AS MANUFACTURED IN HYOGO, JAPAN.

BONISTEIN(TM) - GENISTEIN CRYSTALLINE AS MANUFACTURED IN SISSEIN, SWITZERLAND. ST GOBAIN PERFORMANCE PLASTICS CORP TYGON (R)R 3350 - SANITARY SILICONE TUBING AS MANUFACTURED IN BEAVERTON, MI ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN OLOMOUC, CZECH REPUBLIC. FLUNISOLIDE ANHYDROUS USP AS MANUFACTURED IN GROPELLO CAIROLI, ITALY. CEFEPIME HYDROCHLORIDE, NON-STERILE INTERMEDIATE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. BENAZEPRIL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA. TERAZOSIN HYDROCHLORIDE AS MANUFACTURED IN ORIGGIO, ITALY. DERMAZ 99 (AZELAIC ACID) AS MANUFACTURED IN QUEBEC, CANADA. FOR COGNIS CORP CICLETANINE AS MANUFACTURED IN ARAMON, FRANCE FOR PCAS 3M MEDICAL TAPE #1577 AS MANUFACTURED IN BROOKINGS, SD FOR 3M DRUG DELIVERY SYSTEMS DIVISION

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4Q2012EXCEL DMF# 19484 A 19485 19486 19487 19488 19489 A 19490 19491 19492 A 19493 19494 19495 19496 19497 A 19498 A 19499 19500 19501 19502 A 19503 A 19504 A 19505 19506 A 19507 C 19508 19509 I 19510 19511 A 19512 19513 19514 A A N II 6/12/2006 II 8/23/2005 A II II 6/7/2006 6/6/2006 ITF CHEMICAL LTDA ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTD BRISTOL MYERS SQUIBB CO NOT AN ASSIGNED NUMBER FIDIA FARMACEUTICI SPA DIVISIONE SOLMAG A II II 6/7/2006 6/7/2006 RANBAXY LABORATORIES LTD NV ORGANON II 6/6/2006 I III II 5/10/2006 6/7/2006 ONAWAY INDUSTRIES LTD (GLASS DIV) CHONGQING DAXIN PHARMACEUTICAL CO LTD TEVA PHARMACEUTICAL INDUSTRIES LTD III 6/7/2006 DYNIC USA CORP II 5/30/2006 WOCKHARDT LTD A A A II II III III 6/6/2006 5/27/2006 3/26/2006 6/7/2006 II 6/1/2006 HELSINN CHEMICALS SA HELSINN ADVANCED SYNTHESIS SA SUN PHARMACEUTICAL INDUSTRIES LTD WOCKHARDT LTD LUXFER GAS CYLINDERS DYNIC USA CORP A I A I III V II II II 5/2/2006 5/4/2006 6/5/2006 4/30/2006 3/31/2006 AEGIS AMPOULES AND VIALS LTD ISOTRON NEDERLAND BV SIFAVITOR SRL TAI HENG INDUSTRY CO LTD CHEMPACIFIC CORP A A II III III 6/1/2006 5/2/2006 5/2/2006 AARTI DRUGS LTD AEGIS AMPOULES AND VIALS LTD AEGIS AMPOULES AND VIALS LTD A A A I II III II III II 5/31/2006 6/2/2006 5/30/2006 6/1/2006 5/30/2006 TRACE LIFE SCIENCES INC REXAM HEALTHCARE OFFRANVILLE SAS QUIMICA SINTETICA SA APPLE CONVERTING INC POLYMED THERAPEUTICS INC STATUS Type SUBMIT DATE II 5/31/2006 HOLDER AUROBINDO PHARMA LTD SUBJECT

4Q2012

PERINDOPRIL TERT-BUTYLAMINE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. COPPER CHLORIDE (CU-64) RADIOCHEMICAL AS MANUFACTURED IN DENTON, TEXAS. SOF' BAG SETS AS MANUFACTURED IN OFFRANVILLE, FRANCE. LEVOFLOXACIN AS MANUFACTURED IN MADRID, SPAIN. PACKAGING FILMS AND PAPERS AS MANUFACTURED IN NORWICH, NY. CHOLECALCIFEROL CRYSTAL (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA FOR POLYMED THERAPEUTICS INC METOPROLOL SUCCINATE AS MANUFACTURED IN MAHARASHTRA, INDIA. NEUTRAL GLASS AMPOULES AS MANUFACTURED IN MAHARASHTRA, INDIA. GLASS CYLINDERS FOR DENTAL LOCAL ANESTHETIC CARTRIDGES AND PEN INJECTOR CARTRIDGES AS MANUFACTURED IN MAHARASHTRA, INDIA. NEUTRAL GASS TUBULAR VIALS AS MANUFACTURED IN MAHARASHTRA, INDIA. ISOTRON NEDERLAND FACILITY IN EDE, THE NETHERLANDS. BETAHISTINE DIHYDROCHLORIDE AS MANUFACTURED IN LODI, ITALY. ANASTROZOLE AS MANUFACTURED IN SHANGHAI, CHINA. DYCLONINE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE, MD. DANTROLENE SODIUM DRUG SUBSTANCE AS MANUFACTURED IN BIASCA, SWITZERLAND. IMATINIB MESYLATE AS MANUFACTURED IN MAHARASHTRA, INDIA. RANITIDINE HYDROCHLORIDE USP (FORM II) AS MANUFACTURED IN GUJARAT, INDIA. COMPRESSED GAS CYLINDER PACKAGE AS MANUFACTURED IN RIVERSIDE, CA. NK45 BLACK THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN FOR DYNIC USA CORP ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN GUJARAT, INDIA. NK45 WHITE INK THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN FOR DYNIC USA CORP TUBULAR GLASS VIALS CONTAINER AS MANUFACTURED IN MAHARASHTRA, INDIA. TOBRAMYCIN (FORM-1) USP, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, CHINA. IMIQUIMOD AS MANUFACTURED IN DEBRECEN, HUNGARY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD DESLORATADINE DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA. 16-ALPHA-HYDROXYPREDNISOLONE (INTERMEDIATE) AS MANUFACTURED IN OSS, THE NETHERLANDS. TOLTERODINE L-TARTRATE AS MANUFACTURED IN BAHIA, BRAZIL. LEVOFLOXACIN HEMIHYDRATE, USP AS MANUFACTURED IN ZHEJIANG, CHINA. MDX-010 (ANTI-CTLA4 HUMAN MONOCLONAL ANTIBODY) SODIUM HYALURONATE OPHTHALMIC - FERMENTATIVE ORIGIN (TOPICAL GRADE) AS MANUFACTURED IN PADOVA, ITALY.

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4Q2012EXCEL DMF# 19515 A 19516 A 19517 A 19518 19519 19520 A 19521 A 19522 19523 19524 19525 A 19526 A 19527 19528 19529 19530 19531 19532 19533 A 19534 19535 19536 A 19537 19538 A 19539 A 19540 A 19541 A 19542 A 19543 19544 A I IV II 6/23/2006 6/26/2006 II 6/20/2006 II 6/20/2006 III 6/21/2006 II 6/22/2006 A II IV 6/14/2006 6/20/2006 SYN TECH CHEM AND PHARM CO LTD FERRO PFANSTIEHL INC A A II II II 6/19/2006 6/20/2006 6/19/2006 A A A A A A II II II IV II II II 5/29/2006 6/14/2006 6/19/2006 6/13/2006 4/30/2006 4/30/2006 6/15/2006 II 6/14/2006 A A I II II III II 6/15/2006 6/15/2006 6/15/2006 6/19/2006 II 6/1/2006 QILU ANTIBIOTICS PHARMACEUTICAL CO LTD UNIMARK REMEDIES LTD NATCO PHARMA LTD BAXTER HEALTHCARE CORP CEFUROXIME SODIUM, STERILE BULK ANTIBIOTIC DRUG SUBSTANCE AS MANUFACTURED IN SHANDONG PROVINCE, CHINA. RAMIPRIL USP AS MANUFACTURED IN GUJARAT, INDIA. ZOLEDRONIC ACID AS MANUFACTURED IN ANDHRA PRADESH, INDIA. I I III III IV 6/6/2006 6/6/2006 5/24/2006 II 6/12/2006 AMRI RENSSELAER INC SUB ALBANY MOLECULAR RESEARCH INC POLIMERI EUROPA FRANCE POLIMERI EUROPA FRANCE NIACET CORP II 6/5/2006 AUROBINDO PHARMA LTD STATUS Type SUBMIT DATE II 6/9/2006 HOLDER ENDORECHERCHE INC SUBJECT

4Q2012

ACOLBIFENE CAPSULES, 20 MG AS MANUFACTURED IN WILMINGTON, NC FOR ENDORECHERCHE INC QUETIAPINE FUMARATE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. DEXTROAMPHETAMINE DRUG INTERMEDIATE AS MANUFACTURED IN RENSSELAER, NEW YORK. RIBLENE FC30 AS MANUFACTURED IN RAGUSA AND GELA, ITALY. RIBLENE BD20 AS MANUFACTURED IN RAGUSA AND GELA, ITALY. CALCIUM ACETATE USP GRADE - EXCIPIENT AS MANUFACTURED IN NIAGARA FALLS, NY.

CLEARSHOT PLASTIC PREFILLED SYRINGES AS MANUFACTURED IN CLEVELAND, MS.

CSPC ZHONGRUN PHARMACEUTICAL INNER 6-AMINOPENICILLANIC ACID (ESUB) AS MANUFACTURED IN INNER MONGOLIA, CHINA MONGOLIA CO LTD CRYSTAL PHARMA SAU OLOPATADINE HYDROCHLORIDE (PROCESS I) AS MANUFACTURED IN VALLADOLID, SPAIN. CENWAY PHARMACEUTICALS LTD PACLITAXEL, NON-STERILE BULK FORM AS MANUFACTURED IN TIANJIN, CHINA. CRYSTAL PHARMA SAU HOFFMANN LA ROCHE INC UNGERER AND CO CAMBREX KARLSKOGA AB CAMBREX KARLSKOGA AB ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD ISOCHEM SAS FINETECH PHARMACEUTICAL LTD KREBS BIOCHEMICALS INDUSTRIES LTD BUDESONIDE STERILE MICRONIZED AS MANUFACTURED IN VALLADOLID, SPAIN. INTERLEUKIN-2 (HUMAN, RECOMBINANT, E. COLI, HOFFMAN-LA ROCHE) N/A CHERRY FLVP FLAVOR WS FO-1979 AS MANUFACTURED IN BETHLEHEM, PA. LIDOCAINE HYDROCHLORIDE AS MANUFACTURED IN KARLSKOGA SWEDEN LIDOCAINE AS MANUFACTURED IN KARLSKOGA SWEDEN CARVEDILOL AS MANUFACTURED IN ZHEJIANG, CHINA. AMBOX AS MANUFACTURED IN PITHIVIERS, FRANCE FOR ISOCHEM SA LATANOPROST (LAT-00) DRUG SUBSTANCE AS MANUFACTURED IN NESHER, ISRAEL. SIMVASTATIN AMMONIUM SALT (INTERMEDIATE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. LANSOPRAZOLE AS MANUFACTURED IN HSIN-YING, TAIWAN R.O.C.

SUCROSE USP - NF, EP, JP, HIGH PURITY, LOW ENDOTOXIN, BEET DERIVED (S-124-2-MC) AS MANUFACTURED IN WAUKEGAN, IL. CHINOIN PHARMACEUTCIAL AND CHEMICAL EPOPROSTENAL SODIUM DRUG SUBSTANCE AS MANUFACTURED IN BUDAPEST, WORKS CO LTD HUNGARY. NYPRO INC FLOVENTR 120 DOSE 8ML METERED-DOSE INHALER COUNTER ACTUATOR/STRAPCAP AS MANUFACTURED IN ARDEN, NC FOR NYPRO INC ZHEJIANG SUPOR PHARMACEUTICALS CO LAMOTRIGINE, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG LTD PROVINCE, CHINA. ZHEJIANG SUPOR PHARMACEUTICALS CO QUETIAPINE FUMARATE, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN LTD ZHEJIANG PROVINCE, CHINA. ASSOCIATED CAPSULES PVT LTD CELLULOSE CAPSULE SHELLS (EXCIPIENT) AS MANUFACTURED IN MUMBAI, INDIA. CILAG AG IRON SUCROSE DRUG SUBSTANCE AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND. Page

584

4Q2012EXCEL DMF# 19545 A 19546 A 19547 A 19548 19549 A 19550 19551 19552 A 19553 19554 19555 19556 19557 A 19558 A 19559 19560 I 19561 A 19562 A 19563 19564 I 19565 19566 19567 19568 A 19569 A 19570 19571 I 19572 19573 19574 A A A II II II 6/29/2006 7/3/2006 7/6/2006 CHEMAGIS LTD HOSPIRA BOULDER INC FARMABIOS S P A ROCURONIUM BROMIDE AS MANUFACTURED IN BEER SHEVA, ISRAEL. PAMIDRONIC ACID DRUG SUBSTANCE AS MANUFACTURED IN BOULDER, CO. DESONIDE DRUG SUBSTANCE AS MANUFACTURED IN PAVIA, ITALY. I II II 6/29/2006 6/4/2006 NECTAR LIFESCIENCES LTD WORLD JIANGSU INDUSTRY CO LTD II 6/30/2006 A A A III II II II 6/28/2006 6/30/2006 6/28/2006 6/20/2006 A II II 6/16/2006 6/23/2006 III 6/29/2006 MULTISORB TECHNOLOGIES INTERNATIONAL INKE SA CHINA NATIONAL PHARMACEUTICAL FOREIGN TRADE CORP RICON COLORS INC MYLAN LABORATORIES LTD CHEMI SPA ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD SRI KRISHNA PHARMACEUTICALS LTD II 6/29/2006 NORAMCO INC C II II 6/28/2006 6/29/2006 TEVA PHARMACEUTICAL INDUSTRIES LTD ABBOTT HEALTHCARE PRODUCTS BV OXALIPLATIN AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO. II 6/28/2006 A A A A II II II II II 6/20/2006 6/28/2006 6/27/2006 6/28/2006 5/29/2006 AUROBINDO PHARMA LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD MITSUBISHI TANABE PHARMA CORP SAFC BIOSCIENCES INC A A II II II 6/27/2006 6/27/2006 6/26/2006 A II II 6/21/2006 6/20/2006 II 6/26/2006 II 4/30/2006 STATUS Type SUBMIT DATE II 4/20/2006 HOLDER HENAN TOPFOND PHARMACEUTICAL CO LTD TAI HENG INDUSTRY CO LTD SUBJECT

4Q2012

SIMVASTATIN, NON-STERILE BULK FORM AS MANUFACTURED IN HENAN PROVINCE, CHINA FOR HENAN TOPFOND PHARMACEUTICAL CO. LTD. BICALUTAMIDE AS MANUFACTURED IN JIANGSU, CHINA FOR TAI HENG INDUSTRY CO LTD JOHNSON MATTHEY INC PHARMACEUTICAL METHYLPHENIDATE HYDROCHLORIDE, USP AS MANUFACTURED IN WEST DEPTFORD, MATERIALS GROUP NJ. AUROBINDO PHARMA LTD TRANDOLAPRIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA. AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPA CAMBREX CHARLES CITY INC TARO PHARMACEUTICAL INDUSTRIES LTD CHEMWERTH INC MEMANTINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MILANO, ITALY. PHENYLEPHRINE HYDROCHLORIDE AS MANUFACTURED IN CHARLES CITY, IA. BUTENAFINE HYDROCHLORIDE AS MANUFACTURED IN HAIFA, ISRAEL. NICARDIPINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN FREIBURG, GERMANY FOR CHEMWERTH INC DICLOXACILLIN SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ARIPIPRAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA LANSOPRAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA MP-124 DRUG SUBSTANCE AS MANUFACTURED IN CHIBA, JAPAN.

EX-CELL XJEM WITHOUT L-GLUTAMINE, WITHOUT SODIUM BICARBONATE AS MANUFACTURED IN DENVER, PA ZHEJIANG HUAYI PHARMACEUTICAL CO LTD PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, CHINA.

BIFEPRUNOX MESYLATE BULK DRUG SUBSTANCE AS MANUFACTURED IN WEESP, THE NETHERLANDS. HYDROMORPHONE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN ATHENS, GA. NATRASORBR DESICCANT PRODUCTS AS MANUFACTURED IN CHESHIRE, UNITED KINGDOM FOR MULTISORB TECHNOLOGIES INTERNATIONAL QUETIAPINE HEMIFUMARATE AS MANUFACTURED IN BARCELONA, SPAIN. RITALINIC ACID AS MANUFACTURED IN JIANGSU PROVINCE, CHINA FOR CHINA NATIONAL PHARMACEUTICAL FOREIGN TRADE CORP. FDA BLACK, CPP-BK1296-1 AS MANUFACTURED IN WEST CHICAGO, IL. EMTRICITABINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. OCTREOTIDE ACETATE AS MANUFACTURED IN MILANO, ITALY. METOPROLOL SUCCINATE USP ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. SODIUM-4-PHENYL BUTYRIC (4-PHENYL BUTYRIC ACID SODIUM SALT) DRUG SUBSTANCE/API (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CEFUROXIME AXETIL AMORPHOUS USP AS MANUFACTURED IN PUNJAB, INDIA. TEICOPLANIN, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN FUJIANG, CHINA.

Page 585

4Q2012EXCEL DMF# 19575 A 19576 19577 A 19578 A 19579 19580 A 19581 19582 A 19583 19584 19585 A 19586 19587 19588 A 19589 19590 19591 19592 I 19593 II 6/23/2006 DISPHAR INTERNATIONAL B.V. A A A II II II III 7/12/2006 7/10/2006 7/11/2006 7/5/2006 SUN PHARMACEUTICAL INDUSTRIES LTD NEULAND LABORATORIES LTD GLOCHEM INDUSTRIES LTD ROHM AND HAAS CO A A II II II 7/11/2006 6/30/2006 6/30/2006 FORMOSA LABORATORIES INC LUPIN LTD AUROBINDO PHARMA LTD A A II II III 6/26/2006 6/30/2006 6/23/2006 A III II 7/7/2006 7/7/2006 A II II 7/5/2006 7/2/2006 BCN PEPTIDES TAIZHOU HIGHSUN PHARMACEUTICAL CO LTD BRENNTAG CANADA INC ORCHID CHEMICALS AND PHARMACEUTICALS LTD CADILA PHARMACEUTICALS LTD PHARMACOSMOS AS THERMODORS PVT LTD II 6/28/2006 AUROBINDO PHARMA LTD A III IV 6/30/2006 7/3/2006 CLARIANT MASTERBATCHES NORDEN AB NIPPON FINE CHEMICAL CO LTD STATUS Type SUBMIT DATE II 6/29/2006 HOLDER CONTIPRO PHARMA AS SUBJECT

4Q2012

SODIUM HYALURONATE DRUG SUBSTANCE AS MANUFACTURED IN DOLNI DOBROUC, CZECH REPUBLIC. PPZ1944910 REMAFIN(R) BLUE AS MANUFACTURED IN MALMO, SWEDEN. DIERUCOYLPHOSPHATIDYLCHOLINE (DEPC), A LIPOSOMAL EXCIPIENT, AS MANUFACTURED IN HYOGO, JAPAN . PANTOPRAZOLE SODIUM SESQUIHYDRATE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. SALMON CALCITONIN AS MANUFACTURED IN BARCELONA, SPAIN. GLIPIZIDE USP, NON-STERILE DRUG SUBSTANCE, AS MANUFACTURED IN ZHEJIANG, CHINA. COLOR CONCENTRATE WHITE 33692DF AS MANUFACTURED IN ONTARIO, CANADA. AMLODIPINE BESYLATE AS MANUFACTURED IN MAHARASHTRA, INDIA. CHLORHEXIDINE GLUCONATE AS MANUFACTURED IN GUJARAT, INDIA. DEXTRAN POWDER ACTIVE INGREDIENT AS MANUFACTURED IN HOLBAEK, DENMARK. PLASTIC BOTTLE, NOZZLE AND PILFER PROOF CAP - READY TO USE STERILE DROPPER ASSEMBLY AS MANUFACTURED IN PUNE, INDIA. DDAIP.HCI AS MANUFACTURED IN TAOYUAN, TAIWAN R.O.C. BICALUTAMIDE AS MANUFACTURED IN MAHARASHTRA, INDIA. CITALOPRAM HYDROBROMIDE USP (ROUTE-1) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. AMITRIPTYLINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA. ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. AMLODIPINE BESILATE P-III EP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. AQUA-LAM 444A AND CR 7-103 AS MANUFACTURED IN TOLUCA EDO, MEXICO FOR ROHM AND HAAS CO BETAHISTINE.2HCL, 8MG AND 16MG TABLETS AS MANUFACTURED BY LOSAN PHARMA GMBH IN NEUENBERG, FEDERAL REPUBLIC OF GERMANY; CARDINAL HEALTH FEDERAL REPUBLIC OF GERMANY 405 GMBH IN SCHORNDORF, FEDERAL REPUBLIC OF GERMANY; SIFAVITOR S.P.A. IN CASALETTO LODIGIANO, ITALY FOR DISPHAR INTERNATIONAL B.V. OXALIPLATIN AS MANUFACTURED IN BRNO, CZECH REPUBLIC. SODIUM AZIDE AS MANUFACTURED IN HYDERABAD, INDIA. HYDROXYZINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. 181691 DARK BROWN POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; LATEXO, TX: CARTERSVILLE, GA; HEATH, OH AND DERIDDER, LA. ELN-NM-101-G AS MANUFACTURED IN GAINESVILLE, GA. TOLTERODINE TARTRATE AS MANUFACTURED IN BARCELONA, SPAIN. LOPINAVIR (LVR) AS MANUFACTURED IN HYDERABAD, ANDHRA PRADESH, INDIA INDOCYANINE GREEN DRUG SUBSTANCE AS MANUFACTURED IN WOLFEN, GERMANY. PVC FILM AND ALUMINIUM FOIL AS MANUFACTURED IN GOA AND DAMAN, INDIA. TECHCRYL 2201 WATER BASED ADHESIVES AS MANUFACTURED IN GRAFTON, WV. 46344-CD1 AS MANUFACTURED IN CUYAHOGA FALLS OH

I 19594 19595 19596 19597 I 19598 19599 19600 19601 19602 19603 19604 A A A A A I A II II II II III III III 7/14/2006 7/14/2006 7/17/2006 7/13/2006 7/14/2006 7/17/2006 2/15/2007 ALKERMES GAINESVILLE LLC INTERQUIM SA MYLAN LABORATORIES LTD ORGANICA FEINCHEMIE GMBH WOLFEN ESS DEE ALUMINIUM LTD DYNA TECH ADHESIVES AMERICHEM INC A A A II II II III 7/11/2006 6/20/2006 7/12/2006 6/22/2006 PLIVA LACHEMA AS ALKALI METALS LTD SYMED LABS LTD AMPACET CORP

Page 586

4Q2012EXCEL DMF# 19605 A 19606 A 19607 A 19608 A 19609 19610 A 19611 19612 19613 A 19614 I 19615 19616 19617 19618 A 19619 I 19620 A 19621 A 19622 19623 A 19624 19625 19626 19627 19628 A 19629 A 19630 A 19631 19632 A I II II 7/25/2006 7/27/2006 CADILA HEALTHCARE LTD JAGSONPAL PHARMACEUTICALS LTD II 6/29/2006 ROCHE CAROLINA INC II 7/25/2006 DAIICHI SANKYO CO LTD A A A A II II II II II 7/10/2006 7/21/2006 6/30/2006 7/21/2006 7/20/2006 FIDIA FARMACEUTICI SPA INTERQUIM SA LUPIN LTD FRESENIUS KABI ANTI INFECTIVES SRL HERCULES INC., AQUALON DIV A II II 7/10/2006 7/10/2006 FIDIA FARMACEUTICI SPA FIDIA FARMACEUTICI SPA LETROZOLE DRUG SUBSTANCE AS MANUFACTURED IN MULAZZANO, ITALY. II 7/10/2006 II 7/24/2006 BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG FIDIA FARMACEUTICI SPA II 6/15/2006 DELAVAU LLC I I I III IV IV II 7/18/2006 7/21/2006 7/20/2006 7/21/2006 II 7/10/2006 A A II II II 7/17/2006 7/4/2006 7/17/2006 AARTI DRUGS LTD R L FINE CHEM A III II 7/18/2006 7/17/2006 ASHLAND INC FRESENIUS KABI ONCOLOGY LTD II 7/10/2006 AUROBINDO PHARMA LTD II 7/11/2006 AUROBINDO PHARMA LTD III 7/14/2006 FLEX ART FOIL LTD STATUS Type SUBMIT DATE II 3/16/2007 HOLDER AUROBINDO PHARMA LTD SUBJECT

4Q2012

ATOMOXETINE HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA PLAIN ALUMINIUM FOIL/GLASSINE/LAMINATES AND PRINTED ALUMINIUM FOIL/GLASSINE/LAMINATES/CR FOIL AS MANUFACTURED IN VASAI, DAMAN AND GOA, INDIA. CEFDINIR CRYSTAL B DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. SULBACTAM SODIUM USP (NON-STERILE BULK)AS MANUFACTURED IN ANDHRA PRADESH, INDIA. FLEXCRYL GP6W EMULSION AS MANUFACTURED IN PIEDMONT, SC. OXALIPLATIN (ESUB) AS MANUFACTURED IN WEST BENGAL, INDIA. CIPROFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA. IMIPRAMINE PAMOATE DRUG SUBSTANCE AS MANUFACTURED IN BANGALORE, INDIA.

ZHEJIANG HISUN PHARMACEUTICAL CO LTD IDARUBICIN HYDROCHLORIDE, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. AXITEC CO LTD FLUDARABINE PHOSPHATE USP, NON-STERILE BULK DRUG AS MANUFACTURED IN JIANGSU PROVINCE, CHINA. POLIMERI EUROPA FRANCE RIBLENE FL24 AS MANUFACTURED IN MARDYCK, FRANCE. CAFOSA GUM SA QUALICAPS CO LTD SYNTESE AS ALL IN GUM SF ART AS MANUFACTURED IN BARBERA DEL VALLES, SPAIN. EMPTY PONDAC CAPSULES AS MANUFACTURED IN NARA, JAPAN. MESALAMINE (5-AMINOSALICYLIC ACID) DRUG SUBSTANCE AS MANUFACTURED IN HVIDOVRE, DENMARK. CALCIUM CARBONATE GRANULATION ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN PHILADELPHIA, PA. REPAGLINIDE DRUG SUBSTANCE AS MANUFACTURED IN INGELHEIM AM RHEIN, GERMANY. ADAPALENE DRUG SUBSTANCE AS MANUFACTURED IN GARBAGNATE MILANESE, ITALY.

ATOMOXETINE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN GARBAGNATE MILANESE, ITALY. BICALUTAMIDE DRUG SUBSTANCE AS MANUFACTURED IN MULAZZANO, ITALY. TOLTERODINE TARTRATE MICRONIZED AS MANUFACTURED IN BARCELONA, SPAIN. PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA. CEFTRIAXONE SODIUM STERILE AS MANUFACTURED IN ROVIGO, ITALY. BENECEL(R) HYDROXYPROPYLMETHYLCELLULOSE (HPMC) AS MANUFACTURED IN BEVEREN, BELGIUM. BENICAR HCTR (OLMESARTAN MEDOXOMIL HYDROCHLOROTHIAZIDE) TABLETS, 20/12.5 MG, 40/12.5 MG AND 40/25 MG AS MANUFACTURED IN KANAGAWA, JAPAN. MSBA30K PEG REAGENT FOR MIRCERA (RO0503819) AS MANUFACTURED IN FLORENCE, SC. DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA. D-OXYPHENE AS MANUFACTURED IN FARIDABAD, INDIA.

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4Q2012EXCEL DMF# 19633 C 19634 19635 19636 I 19637 19638 19639 A 19640 A 19641 A 19642 19643 19644 A 19645 A 19646 19647 19648 A 19649 A 19650 A 19651 I 19652 19653 A 19654 A 19655 19656 A 19657 A 19658 19659 A 19660 I II 7/27/2006 SAI PHYTOCEUTICALS PVT LTD A II III 8/4/2006 8/1/2006 II 7/5/2006 ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD OPOCRIN SPA BASELL POLYOLEFINE ITALIA SPA A II II 8/3/2006 8/4/2006 ANTIBIOTICOS DO BRASIL LTDA ABBOTT LABORATORIES ARGININE USP, STERILE BULK AS MANUFACTURED IN COSMOPOLIS, BRAZIL. V 7/28/2006 A II IV 8/3/2006 7/4/2006 ERREGIERRE SPA DOOSAN RESEARCH AND DEVELOPMENT CENTER CELSIS INC III 6/15/2006 RITE SYSTEMS INC III 8/2/2006 LABLABO II 7/31/2006 AUROBINDO PHARMA LTD A A II II II 7/31/2006 8/2/2006 8/4/2006 II 8/3/2006 ORCHID CHEMICALS AND PHARMACEUTICALS LTD LONZA BRAINE SA SUVEN LIFE SCIENCES LTD SUN PHARMACEUTICAL INDUSTRIES LTD A A II II II 7/31/2006 7/26/2006 7/28/2006 NOF CORP AUROBINDO PHARMA LTD AUROBINDO PHARMA LTD II 7/22/2006 WANBURY LTD IV 7/20/2006 ACG ASSOCIATED CAPSULES PRIVATE LTD A A III II II 7/31/2006 8/24/2006 7/22/2006 HEINLEIN PLASTIK TECHNIK GMBH IPCA LABORATORIES LTD WANBURY LTD A A III II II 7/28/2006 7/28/2006 6/14/2006 STATUS Type SUBMIT DATE II 7/28/2006 HOLDER HERAEUS PRECIOUS METALS GMBH AND CO KG POLYONE CORP VASUDHA PHARMA CHEM LTD EPOCH BIOSCIENCES SHENZHEN CO LTD SUBJECT OXALIPLATIN AS MANUFACTURED IN HANAU, GERMANY.

4Q2012

CC00011090WE 10098632 TAN 467C AS MANUFACTURED IN ELK GROVE VILLAGE, IL. AMITRIPTYLINE HYDROCHLORIDE USP AS MANUFACTURED IN HYDERABAD, INDIA. FENOLDOPAM MESYLATE BULK ACTIVE API AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA CLOSURES FOR BOTTLES AS MANUFACTURED IN ANSBACH, GERMANY. METOPROLOL SUCCINATE PROCESS-II (ESUB) AS MANUFACTURED IN RATLAM, INDIA. GLUCOSAMINE SULFATE POTASSIUM CHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR WANBURY LTD. EXCIPIENT CELLULOSE CAPSULE SHELLS AS MANUFACTURED IN THANE, INDIA. GLUCOSAMINE SULFATE SODIUM CHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR WANBURY LTD. DSPC (DISTEAROYL PHOSPHATIDYLCHOLINE) AS MANUFACTURED IN HYOGO, JAPAN. CEFACLOR USP DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. CEFTAZIDIME DIHYDROCHLORIDE, NON-STERILE DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. MODAFINIL AS MANUFACTURED IN MAHARASHTRA, INDIA. EXENATIDE DRUG SUBSTANCE AS MANUFACTURED IN BRAINE-L'ALLEUD, BELGIUM. TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. OXALIPLATIN EP/BP ACTIVE SUBSTANCE AS MANUFACTURED IN MAHARASHTRA, INDIA. TOLTERODINE TARTRATE, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. SELECT AIRLESS PUMP AND BOTTLE AS MANUFACTURED IN ANNEMASSE CEDEX, FRANCE. WHITE, NQC-W1317-7, LIQUID COLOR CONCENTRATE AS MANUFACTURED IN MOORESVILLE, NC. CELECOXIB AS MANUFACTURED IN BERGAMO, ITALY. DS-PL95E PURIFIED EGG YOLK LECITHIN FOR UTILIZATION IN FAT EMULSION PRODUCTION AS MANUFACTURED IN IKSAN CITY, REPUBLIC OF KOREA. CELSIS RAPISCREEN HEALTH AS MANUFACTURED IN LANDGRAAF, THE NETHERLANDS.

HYDROCODONE/ACETAMINOPHEN EXTENDED RELEASE TABLETS (ESUB) AS MANUFACTURED IN LUDWIGSHAFEN GERMANY FOR ABBOTT LABORATORIES METHOCARBAMOL ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. DALTEPARIN SODIUM BULK AS MANUFACTURED IN MODENA, ITALY. PURELL PE 3220 D AS MANUFACTURED IN WESSELING, GERMANY FOR BASELL POLYOLEFINE ITALIA S.R.L. PACLITAXEL AS MANUFACTURED IN MADHYA PRADESH, INDIA.

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4Q2012EXCEL DMF# 19661 I 19662 19663 19664 19665 19666 19667 19668 I 19669 I 19670 19671 A 19672 A 19673 A 19674 A 19675 19676 19677 I 19678 19679 19680 19681 A 19682 19683 19684 19685 19686 19687 19688 19689 19690 A 19691 19692 A 19693 A II 8/16/2006 A III II 8/10/2006 8/17/2006 A A A A A A A A III II 8/14/2006 8/15/2006 II II II II II II 8/11/2006 8/10/2006 8/3/2006 8/15/2006 8/14/2006 8/11/2006 SYNTHON BV NAVINTA LLC FIDIA FARMACEUTICI SPA CEPHALON INC STERLING SRL NATCO PHARMA LTD TRANSFERRED TO CBER APTAR FRANCE SAS A A A II II II III 8/14/2006 8/10/2006 8/7/2006 8/4/2006 A A II II II 8/10/2006 7/10/2006 6/16/2006 GLENMARK GENERICS LTD ANUH PHARMA LTD SHANDONG NEW TIME PHARMACEUTICAL CO LTD SYMED LABS LTD SANDOZ INDUSTRIAL PRODUCTS SA SHASUN PHARMACEUTICALS LTD E I DUPONT DE NEMOURS & CO INC III 8/7/2006 II 8/7/2006 AJINOMOTO DO BRASIL IND E COM DE ALIMENTOS LTDA ADVANCED FILMS LLC II 7/10/2006 PHARMAZELL GMBH CO KG A II II 8/9/2006 8/5/2006 II 8/6/2006 A A A A A A II II IV IV IV IV II 8/7/2006 6/20/2006 7/31/2006 7/31/2006 7/31/2006 7/31/2006 8/6/2006 NEULAND LABORATORIES LTD ARCH PHARMALABS LTD UNGERER AND CO UNGERER AND CO UNGERER AND CO UNGERER AND CO ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD DAIICHI SANKYO CO LTD AUROBINDO PHARMA LTD STATUS Type SUBMIT DATE II 7/27/2006 HOLDER SAI PHYTOCEUTICALS PVT. LTD. SUBJECT

4Q2012

IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN MADHYA PRADESH, INDIA. ESCITALOPRAM OXALATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ESCITALOPRAM OXALATE AS MANUFACTURED IN MAHARASHTRA, INDIA. N/A COUGH SYRUP MASKER FLAVOR FN-6819 AS MANUFACTURED BETHLEHEM, PA. N/A CHERRY BERRY FL FM-4725 AS MANUFACTURED BETHLEHEM, PA. ART. STRAWBERRY FLAVOR FO-1022 AS MANUFACTURED BETHLEHEM, PA. N/A STRAWBERRY FL WS FN-8378 AS MANUFACTURED BETHLEHEM, PA. MERCAPTOPURINE, USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN ZHEJIANG, CHINA. AZATHIOPRINE USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN ZHEJIANG, CHINA. SUN13834 DRUG SUBSTANCE AS MANUFACTURED IN TOKYO, JAPAN. LOSARTAN POTASSIUM USP DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ATENOLOL USP AS MANUFACTURED IN CHENNAI, INDIA FOR PHARMAZELL GMBH & CO KG L-GLUTAMINE AS MANUFACTURED INLIMEIRA, BRAZIL. MEDICAL POUCH FILM AS MANUFACTURED IN LAKEVILLE,MN AND VANCOUVER, WA FOR ADVANCED FILMS LLC ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA. ERYTHROMYCIN USP AS MANUFACTURED IN MAHRASHTRA, INDIA. POTASSIUM CLAVULANATE, DILUTED, NON-STERILE BULK FORM AS MANUFACTURED IN SHANDONG PROVINCE, CHINA. MEPROBAMATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA. NAFCILLIN ACID AS MANUFACTURED IN BARCELONA, SPAIN. MEPROBAMATE AS MANUFACTURED IN CUDDALORE, INDIA. TOPCOAT 3200-200 AS MANUFACTURED IN MECHELEN, BELGIUM FOR E I DUPONT DE NEMOURS & CO INC ARIPIPRAZOLE AS MANUFACTURED IN ZHEJIANG, CHINA FOR SYNTHON BV FOMEPIZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR NAVINTA LLC BALSALAZIDE DISODIUM SALT AS MANUFACTURED IN MULAZZANO, ITALY. ARMODAFINIL DRUG SUBSTANCE AS MANUFACTURED IN NYKOEBING S, DENMARK. TRILOSTANE AS MANUFACTURED IN PERUGIA, ITALY. ANASTROZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. POLYCHLOROPRENE ELASTOMERS AS MANUFACTURED IN VAL DE REUIL, FRANCE.

CHINOIN PHARMACEUTICAL AND CHEMICAL SR47563 - FINAL INTERMEDIATE OF IRBESARTAN AS MANUFACTURED IN BUDAPEST, WORKS PRIVATE CO LTD HUNGARY. LUTZ GMBH AND CO KG AMPOULES AND BOTTLES AS MANUFACTURED IN WERTHEIM, GERMANY. CHONGQING SHENGHUAXI PHARMACEUTICAL CO LTD SIEGFRIED USA LLC FAMCICLOVIR AS MANUFACTURED IN CHONGQING, CHINA. MORPHINE SULFATE USP AS MANUFACTURED IN PENNSVILLE, NJ.

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4Q2012EXCEL DMF# 19694 A 19695 A 19696 19697 A 19698 II 8/21/2006 3M DRUG DELIVERY SYSTEMS DIV A II II 8/18/2006 8/18/2006 SANDOZ GMBH LUPIN LTD II 7/26/2006 BIA SEPARATIONS DOO STATUS Type SUBMIT DATE IV 8/31/2007 HOLDER EASTMAN CHEMICAL CO SUBJECT

4Q2012

BIOSUSTANE(R) SAIB (SUCROSE ACETATE ISOBUTYRATE) AS MANUFACTURED IN KINGSPORT, TN CIM CONVECTIVE INTERACTION MEDIA(R) QA AS MANUFACTURED IN LJUBLJANA, SLOVENIA. STERILE NAFCILLIN SODIUM, BUFFERED AS MANUFACTURED IN KUNDL, AUSTRIA. BENAZEPRIL HYDROCHLORIDE PROCESS B (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA. MINITRAN (NITROGLYCERIN) TRANSDERMAL DELIVERY SYSTEM - CHEMISTRY, MFG & CONTROLS (CMC) FOR DOSAGES: 0.1 MG/HR (2.5 MG/24 HRS), 0.2 MG/HR (5 MG/24 HRS), 0.4 MG/HR (10 MG/24 HRS), 0.6 MG/HR (15 MG/24 HRS) AS MANUFACTURED IN NORTHRIDGE, CA. N/A PINEAPPLE FLAVOR FM-4130 AS MANUFACTURED IN BETHLEHEM, PA. 28505-18014 (LOR 30) COATING LACQUER AS MANUFACTURED IN GREVENBROICH, GERMANY. ZOLEDRONIC ACID AS MANUFACTURED IN BE'ER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD CYANOCOBALAMIN USP AS MANUFACTURED IN MUMBAI, INDIA FOR WOCKHARDT LTD MER-104A GIPET 10MG ENTERIC TABLETS AS MANUFACTURED IN DUBLIN IRELAND HONEYWELL PHARMACEUTICAL HFA-134A AS MANUFACTURED IN GEISMAR, LA FOR HONEYWELL INTERNATIONAL INC DOCOSAHEXAENOIC ACID ACTIVE SINGLE CELL OIL (DHASCO) 55%, DHASCO CAPSULES, 510 MG DHA, AND PLACEBO TO MATCH DHASCO CAPSULES AS MANUFACTURED BY MARTEK BIOSCIENCES WINCHESTER FACILITY IN WINCHESTER, KY AND SWISS CAPS USA INC IN MIAMI, FL. GELATIN TYPE B AS MANUFACTURED IN GUJARAT, INDIA. PLASTIC RESINS, PLASTIC COLORANTS AND PLASTIC ADDITIVES AS MANUFACTURED IN ST. CHARLES, MO. GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA MILRINONE AS MANUFACTURED IN ANDHRA PRADESH INDIA GLYCOPYRROLATE USP AS MANUFACTURED IN MAHARASHTRA INDIA FOSINOPRIL SODIUM AS MANUFACTURED IN ANDHRA PRADESH INDIA NEVIRAPINE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN ZHEJIANG, CHINA. OMEPRAZOLE (FORM B) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. RAMIPRIL USP (GRADE 1) AS MANUFACTURED IN MAHARASHTRA INDIA EPLERENONE AS MANUFACTURED IN SARONNO ITALY CLOTRIMAZOLE AS MANUFACTURED IN SHANGHAI PR CHINA EZETIMIBE AS MANUFACTURED IN GUJARAT, INDIA. EQUADEL METERED DOSE PUMPS AS MANUFACTURED AT LE VAUDREUIL, FRANCE. RAMIPRIL USP, GRADE II AS MANUFACTURED IN MAHARASHTRA, INDIA. TRANDOLAPRIL AS MANUFACTURED IN GUJARAT, INDIA. HYDROCHLOROTHIAZIDE USP AS MANUFACTURED IN HYDERABAD INDIA

I 19699 19700 A 19701 C 19702 19703 19704 A 19705 II 8/25/2006 MARTEK BIOSCIENCES CORP I I II II IV 8/14/2006 4/2/2007 8/18/2006 WOCKHARDT LTD MERRION PHARMACEUTICALS HONEYWELL INTERNATIONAL INC II 8/22/2006 TEVA PHARMACEUTICAL INDUSTRIES LTD A IV III 8/16/2006 8/22/2006 UNGERER AND CO ACTEGA RHENANIA GMBH

A 19706 19707 A 19708 19709 19710 19711 19712 C 19713 19714 19715 19716 A 19717 19718 19719 19720 19721 A A I A A II III II II II 8/30/2006 8/28/2006 8/30/2006 8/26/2006 8/31/2006 A A A II II II II 8/28/2006 8/28/2006 9/8/2006 8/29/2006 A I C A II II II II II 8/21/2006 8/28/2006 8/28/2006 8/17/2006 8/11/2006 WOCKHARDT LTD SAI LIFE SCIENCES LIMITED HARMAN FINOCHEM LTD AUROBINDO PHARMA LTD ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD DR REDDYS LABORATORIES LTD AARTI INDUSTRIES LTD INDUSTRIALE CHIMICA SRL SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTD GLENMARK GENERICS LTD APTAR FRANCE SAS AARTI INDUSTRIES LTD WOCKHARDT LTD POSH CHEMICALS PRIVATE LTD A IV III 8/18/2006 8/22/2006 STERLING BIOTECH LTD PRETIUM PACKAGING LLC

Page 590

4Q2012EXCEL DMF# 19722 A 19723 A 19724 19725 19726 A 19727 I 19728 I 19729 I 19730 19731 A 19732 A 19733 A 19734 19735 19736 19737 A 19738 19739 19740 I 19741 A 19742 19743 A 19744 A 19745 19746 19747 A 19748 19749 A A II II 2/7/2008 8/24/2006 A A II II II 9/11/2006 9/11/2006 9/11/2006 II 9/5/2006 VITALIFE LABORATORIES DIV ARCH PHARMALABS LTD HETERO LABS LTD GLENMARK GENERICS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD CIPLA LTD CIPLA LTD CLOPIDOGREL BISULFATE (ESUB) AS MANUFACTURED IN HARYANA INDIA THALIDOMIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA LINEZOLID AS MANUFACTURED IN GUJARAT INDIA LEVETIRACETAM AS MANUFACTURED IN AURANGABAD MAHARASHTRA INDIA ANASTROZOLE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA ZOLEDRONIC ACID (ESUB) AS MANUFACTURED IN PUNE INDIA A III II 9/1/2006 9/8/2006 II 5/15/2006 A A II II II 8/31/2006 8/31/2006 5/15/2006 A A A II II II II 9/6/2006 9/6/2006 11/7/2006 9/6/2006 TIANJIN JINJIN PHARMACEUTICAL CO LTD GLENMARK GENERICS LTD CAMBRIDGE MAJOR LABS INC BEIJING TAIYANG PHARMACEUTICAL INDUSTRY CO LTD CAMBREX CHARLES CITY INC JUBILANT LIFE SCIENCES LTD HYDROCORTISONE BASE AS MANUFACTURED IN TIANJIN CHINA IMIQUIMOD AS MANUFACTURED IN GUJARAT INDIA FP-062 AS MANUFACTURED IN GERMANTOWN, WI DIPHENHYDRAMINE HYDROCHLORIDE AS MANUFACTURED IN BEIJING CHINA LEVETIRACETAM AS MANUFACTURED IN CHARLES CITY IA ARIPIPRAZOLE AS MANUFACTURED IN KARNATAKA INDIA II 8/31/2006 II 8/31/2006 A II IV 8/31/2006 8/31/2006 AUROBINDO PHARMA LTD NOF CORP II 9/4/2006 DIVIS LABORATORIES LTD II 7/27/2006 BENGBU BAYI PHARMACEUTICAL CO LTD III 8/25/2006 CEODEUX MEDITEC SA A A II II II 7/28/2006 9/1/2006 8/31/2006 CAMBREX CHARLES CITY INC CIPLA LTD II 8/31/2006 STATUS Type SUBMIT DATE II 8/31/2006 HOLDER SUBJECT

4Q2012

MALLADI DRUGS AND PHARMACEUTICALS 2-(4' METHOXYPHENYL) -2-(1-HYDROXYCYCLOHEXYL) ETHYLAMINE ACETATE (MHE LTD ACETATE) AS MANUFACTURED IN TAMIL NADU INDIA HUBEI BIOCAUSE PHARMACEUTICAL CO LTD FLUMAZENIL AS MANUFACTURED IN WUHAN PEOPLES REPUBLIC OF CHINA FENTANYL CITRATE USP MICRONIZED AS MANUFACTURED IN CHARLES CITY IA LANSOPRAZOLE USP (ESUB) AS MANUFACTURED IN BANGALORE INDIA

HUBEI BIOCAUSE PHARMACEUTICAL CO LTD MILRINONE AS MANUFACTURED IN WUHAN PEOPLES REPUBLIC OF CHINA HIGH PRESSURE VALVE RANGE D 335 FOR CYLINDERS CONTAINING GASEOUS MIXTURE DRUGS UNDER PRESSURE AS MANUFACTURED IN LUXEMBOURG PARACETAMOL (OR ALTERNATIVELY KNOWN AS ACETAMINOPHEN) AS MANUFACTURED IN BENGBU CHINA SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA N-[METHOXYPOLYETHYLENE GLYCOL(2000)-CARBAMYL] DISTEAROYLPHOSPHATIDYLETHANOLAMINE (DSPE-PEG2000) AS MANUFACTURED IN KANAGAWA JAPAN

ST GOBAIN PERFORMANCE PLASTICS CORP SANIPURE(TM) BDF(TM) BIOPHARMACEUTICAL TUBING AS MANUFACTURED IN AKRON OHIO ST GOBAIN PERFORMANCE PLASTICS CORP TYGON(R) LFL BIOPHARMACEUTICAL TUBING AS MANUFACTURED IN AKRON OHIO

ZHEJIANG WEPON PHARMACEUTICAL CO LORATADINE AS MANUFACTURED IN ZHEJIANG CHINA LTD ZHEJIANG WEPON PHARMACEUTICAL CO CLINDAMYCIN PHOSPHATE AS MANUFACTURED IN ZHEJIANG CHINA LTD KUNSTSTOFFWERK KREMSMUNSTER GMBH PP 28 CAPS T/E AS MANUFACTURED IN KREMSMUNSTER AUSTRIA PHARMACEUTICAL WORKS POLPHARMA SA METOPROLOL SUCCINATE AS MANUFACTURED IN STAROGARD GDANSKI POLAND

Page 591

4Q2012EXCEL DMF# 19750 A 19751 A 19752 19753 19754 A 19755 A 19756 19757 A 19758 19759 19760 19761 19762 19763 19764 19765 19766 A 19767 19768 19769 A 19770 A 19771 A 19772 A 19773 19774 A 19775 19776 19777 19778 A 19779 I 19780 A II 9/11/2006 ALEMBIC PHARMACEUTICALS LTD II 4/3/2007 SHISEIDO CO LTD A A A II II II III 9/13/2006 9/18/2006 9/18/2006 9/19/2006 A II II 9/15/2006 9/14/2006 II 9/1/2006 II 9/1/2006 II 9/1/2006 A A IV II II 9/11/2006 9/2/2006 8/28/2006 A A A A I A I A II II II III II II II II II 9/6/2006 9/11/2006 9/13/2006 9/11/2006 9/13/2006 8/24/2006 9/14/2006 9/12/2006 8/28/2006 ROTEM INDUSTRIES LTD DR REDDYS LABORATORIES LTD CADILA HEALTHCARE LTD ARCH PLASTICS PACKAGING QILU PHARMACEUTICAL CO LTD NAKODA CHEMICALS LTD EURAND INC ISOCHEM SAS A III III 9/11/2006 8/30/2006 SHIN ETSU KASEI KOGYO CO LTD DURAN PRODUKTIONS GMBH AND CO KG II 9/7/2006 AUROBINDO PHARMA LTD A A II II V 9/8/2006 4/3/2008 8/15/2006 II 9/11/2006 ORCHID CHEMICALS AND PHARMACEUTICALS LTD SUVEN LIFE SCIENCES LTD CIPLA LTD SANDOZ GMBH STATUS Type SUBMIT DATE II 8/24/2006 HOLDER CIPLA LTD SUBJECT

4Q2012

BECLOMETHASONE DIPROPIONATE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA PAROXETINE HYDROCHLORIDE AS MANUFACTURED IN AURANGABAD MAHARASHTRA INDIA NITAZOXANIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA NEVIRAPINE HEMIHYDRATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA STERILIZATION PROCESS VALIDATION INFORMATION FOR THE STERILE PENICILLIN PLANT AS MANUFACTURED IN KUNDL TYROL AUSTRIA CEFEPIME FOR INJECTION USP (STERILE BULK) AS MANUFACTURED IN AND ANDHRA PRADESH INDIA ADSORBENT SE-PACK AS MANUFACTURED IN IBARAKI PREFECTURE JAPAN DURAN PREMIUM LABORATORY BOTTLE WITH SCREW CAP AS MANUFACTURED IN MAINZ, GERMANY OXYGEN 18 ENRICHED WATER AS MANUFACTURED IN BEER SHEVA ISRAEL TELMISARTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA METOPROLOL SUCCINATE AS MANUFACTURED IN GUJARAT INDIA PACKAGING MATERIALS AS MANUFACTURED IN CHATTANOOGA, TN ONDANSETRON AS MANUFACTURED IN JINAN CHINA ACETAZOLAMIDE AS MANUFACTURED IN HYDERABAD ANDHRA PRADESH INDIA EUR-1042 ORALLY DISINTEGRATING TABLETS AS MANUFACTURED IN VANDALIA OH TRIMEBUTINE MALEATE AS MANUFACTURED IN PARIS FRANCE

EVONIK REXIM NANNING PHARMACEUTICAL L-ASPARTIC ACID PHIG AS MANUFACTURED IN NANNING CHINA CO LTD NICHIRIN CHEMICAL INDUSTRIES LTD CARMELLOSE JP AS MANUFACTURED IN HYOGO PREFECTURE JAPAN ISOCHEM FENOLDOPAM MESYLATE USP AS MANUFACTURED IN GUANGDONG CHINA EVONIK REXIM NANNING PHARMACEUTICAL L-ALANINE PHIG AS MANUFACTURED IN NANNING CHINA CO LTD SAFC BIOSCIENCES INC EX-CELL 302 CHO SERUM-FREE MEDIUM W/O L-GLUTAMINE AS MANUFACTURED IN DENVER, PA SAFC BIOSCIENCES INC EX-CELL 325 PF CHO (MODIFIED) SERUM-FREE PROTEIN-FREE W/L-GLUTAMINE AS MANUFACTURED IN DENVER PA SAFC BIOSCIENCES INC EX-CELL 325 PF CHO (MODIFIED) SERUM-FREE PROTEIN-FREE W/L-GLUTAMINE W/O SODIUM BICARBONATE NAVINTA LLC NICARDIPINE HYDROCHLORIDE AS MANUFACTURED IN EWING NJ BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG AARTI DRUGS LTD PHOSPHAGENICS LTD ABBEY COLOR INC KYORAKU CO LTD SCOPOLAMINE (HYOSCINE) AS MANUFACTURED IN INGELHEIM, GERMANY TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA TOCOPHERYL PHOSPHATE MIX (TPM) AS MANUFACTURED IN MELBOURNE AUSTRALIA FLUORESCEIN USP AS MANUFACTURED IN PHILADELPHIA PA POLYETHYLENE BAG FOR MEDICAL SUPPLIES (MIRASON 53) AS MANUFACTURED IN HIROSHIMA JAPAN SODIUM HYALURONATE OF PHARMACEUTICAL GRADE CONSISTING OF INTERMEDIATE (SZE AND API (LM) AS MANUFACTURED IN KAKEGAWA, JAPAN ROPINIROLE HYDROCHLORIDE, USP AS MANUFACTURED IN GUJARAT INDIA

Page 592

4Q2012EXCEL DMF# 19781 19782 19783 A 19784 19785 19786 19787 I 19788 A 19789 19790 19791 19792 A 19793 19794 19795 19796 19797 19798 19799 19800 19801 19802 I 19803 I 19804 19805 A 19806 A 19807 I 19808 19809 19810 19811 19812 A 19813 A II 9/28/2006 A A A A II II II IV II 9/27/2006 9/28/2006 8/31/2006 9/28/2006 9/29/2006 II 9/4/2006 II 9/26/2006 A II II 9/28/2006 9/25/2006 II 9/22/2006 TAIZHOU HIGHSUN PHARMACEUTICAL CO LTD GRANULES INDIA LTD AUROBINDO PHARMA LTD A A A A N A A C I II II II II IV 9/26/2006 9/22/2006 9/26/2006 9/26/2006 9/27/2006 III II III II 9/21/2006 10/3/2006 9/25/2006 9/25/2006 A A I II II II II 9/19/2006 9/14/2006 9/21/2006 9/18/2006 ANTIBIOTICOS DO BRASIL LTDA JUBILANT LIFE SCIENCES LTD TRACE LIFE SCIENCES INC ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTD BORMIOLI ROCCO SPA BU PLASTICS CADILA HEALTHCARE LTD PPC INDUSTRIES INC APOTEX PHARMACHEM INC NOT AN ASSIGNED NUMBER ACS DOBFAR SPA SUN PHARMACEUTICAL INDUSTRIES LTD MYLAN LABORATORIES LTD FLEMING LABORATORIES (INDIA) EVONIK DEGUSSA CORP CRUDE CEFEPIME HYDROCHLORIDE AS MANUFACTURED IN MILANO ITALY CEFOXITIN SODIUM STERILE BULK AS MANUFACTURED IN BRASIL IRBESARTAN AS MANUFACTURED IN KARNATAKA INDIA II 9/19/2006 I A I II II II II 11/13/2008 9/22/2006 12/1/2006 9/19/2006 STATUS Type SUBMIT DATE I A II II II 9/20/2006 9/19/2006 9/20/2006 HOLDER SYMBIOTEC PHARMALAB LIMITED DR REDDYS LABORATORIES LTD JOHNSON MATTHEY PHARMACEUTICAL MATERIALS CIPLA LTD CIPLA LTD STANDARD CHEM AND PHARM CO LTD SUBJECT MOMETASONE FUROATE AS MANUFACTURED IN INDORE INDIA BICALUTAMIDE AS MANUFACTURED IN SRIKAKULAM INDIA

4Q2012

TETRAHYDROCANNABINOL (THC) IN SESAME OIL AS MANUFACTURED IN WEST DEPTFORD NJ DIDANOSINE USP (ESUB) AS MANUFACTURED IN BANGALORE, INDIA EMTRICITABINE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN TAINAN TAIWAN

ST GOBAIN PERFORMANCE PLASTICS CORP TYGON 2775 HIGH PURITY TUBING AND TYGON 2275 IB HIGH PURITY PRESSURE TUBING AS MANUFACTURED IN AKRON, OH ST GOBAIN PERFORMANCE PLASTICS CORP PHARMAPURE LOW SPALLATION PUMP TUBING AS MANUFACTURED IN AKRON OH

COPPER CHLORIDE CU-67 RADIOCHEMICAL AS MANUFACTURED IN DENTON TX PROGESTERONE USP (BULK) AS MANUFACTURED IN ZHEJIANG CHINA HDPE BOTTLE 60 ML FI9190 AS MANUFACTURED IN CASTELGUELFO ITALY LANSOPRAZOLE AS MANUFACTURED IN GUJARAT INDIA FORM-FILL-SEAL WEB MATERIAL AS MANUFACTURED IN PLEASANT PRAIRIE WI EPLERENONE AS MANUFACTURED IN ONTARIO CANADA

VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA RITONAVIR USP (FORM-II) ( ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA CARISOPRODOL USP AS MANUFACTURED IN ANDHRA PRADESH INDIA SODIUM ALUMINUM SILICATE AS MANUFACTURED IN WESSELING FEDERAL REPUBLIC OF GERMANY PAROXETINE HYDROCHLORIDE HEMIHYDRATE USP AS MANUFACTURED IN ZHEJIANG CHINA ACETAMINOPHEN USP AS MANUFACTURED IN MEDAK INDIA

SULBACTAM SODIUM USP (STERILE) BULK AS MANUFACTURED IN ANDHRA PRADESH INDIA ANTIBIOTICOS DO BRASIL LTDA CEFEPIME FOR INJECTION USP (STERILE BULK) AS MANUFACTURED IN COSMOPOLIS BRASIL CHONGQING LUMMY PHARMACEUTICAL CO BISOPROLOL FUMARATE USP AS MANUFACTURED IN CHONGQING CITY CHINA LTD CHEMAGIS LTD ANASTROZOLE AS MANUFACTURED IN BEER SHEVA ISRAEL HIKMA PHARMACEUTICALS PLC SANDOZ GMBH LIPOID GMBH ORCHID CHEMICALS AND PHARMACEUTICALS LTD LONZA AG ENALAPRILAT USP AS MANUFACTURED IN AMMAN JORDAN MPI-ACA AS MANUFACTURED IN KUNDL AUSTRIA LIPOID PC 18:1/18:1 (DOPC) AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY ZOLPIDEM TARTRATE AS MANUFACTURED IN CHENNAI INDIA SIROLIMUS AS MANUFACTURED IN VISP SWITZERLAND

Page 593

4Q2012EXCEL DMF# 19814 19815 19816 19817 A 19818 A 19819 19820 A 19821 A 19822 19823 A 19824 19825 19826 19827 A 19828 A 19829 19830 19831 19832 19833 19834 19835 19836 19837 A 19838 I 19839 19840 19841 19842 19843 A 19844 A 19845 A III 10/6/2006 WEATHERCHEM CORPORATION DISPENSING CLOSURE AS MANUFACTURED IN TWINSBURG OH II 10/5/2006 A A A I II II II II II 10/5/2006 10/9/2006 10/9/2006 10/5/2006 10/5/2006 MYLAN LABORATORIES LTD CADILA HEALTHCARE LTD CADILA HEALTHCARE LTD BASF SE III 9/27/2006 ROHM AND HAAS CO A I I I I A A I II III III III III II II II II 10/4/2006 9/27/2006 9/27/2006 9/27/2006 9/27/2006 10/4/2006 9/27/2006 9/26/2006 9/29/2006 TEVA PHARMACEUTICAL INDUSTRIES LTD AMPACET CORP AMPACET CORP AMPACET CORP AMPACET CORP DR REDDYS LABORATORIES LTD JUBILANT LIFE SCIENCES LTD JUBILANT ORGANOSYS LIMITED AUROBINDO PHARMA LTD III 9/28/2006 APTAR FRANCE SAS I A I III III III III 9/25/2006 9/21/2006 6/6/2006 6/6/2006 ROLLPRINT PACKAGING PRODUCTS INC CONSOLIDATED BOTTLE CORP T AND S BLOWMOULDING INC T AND S BLOWMOULDING INC A II II 10/2/2006 9/27/2006 WUHAN SHIJI PHARMACEUTICAL CO LTD AUROBINDO PHARMA LTD IV 10/2/2006 NIPPON FINE CHEMICAL CO LTD A II IV 9/15/2006 10/2/2006 II 8/18/2006 STATUS Type SUBMIT DATE A A A III II II II 6/9/2006 9/29/2006 9/29/2006 9/28/2006 HOLDER ROY AND LECLAIR EMBALLAGE INC UQUIFA ITALIA SPA WOCKHARDT LTD ZHEJIANG HISOAR PHARMACEUTICAL CO LTD SHANDONG NEW TIME PHARMACEUTICAL CO LTD FARMHISPANIA SA NIPPON FINE CHEMICAL CO LTD SUBJECT

4Q2012

BOSTON ROUND FAMILY OF BOTTLES AS MANUFACTURED IN QUEBEC CANADA PYRANTEL PAMOATE USP AS MANUFACTURED IN MILAN ITALY FEXOFENADINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA CLORSULON USP AS MANUFACTURED IN ZHEJIANG CHINA EPIRUBICIN HYDROCHLORIDE AS MANUFACTURED IN SHANDONG CHINA ML-212 (ROCURONIUM BROMIDE) AS MANUFACTURED IN MONTMELO SPAIN A LIPOSOMAL EXCIPIENTDIPALMITOYLPHOSPHATIDYLCHOLINE (DPPC) AS MANUFACTURED IN HYOGO JAPAN A LIPOSOMAL EXCIPIENT 1-PALMITOYL-2-OLEOYL-PHOSPHATIDYLGLYCEROL (POPG) AS MANUFACTURED IN HYOGO JAPAN CLOZAPINE AS MANUFACTURED IN WUHAN CHINA TAZOBACTAM (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN ANDHRA PRADESH INDIA RPP# 36-1216 AS MANUFACTURED IN ADDISON IL 4 LITRE WIDEMOUTH ROUND JAR 110MM AS MANUFACTURED IN ONTARIO CANADA 30ML NATURAL HDPE CYLINDER (RESIN SCLAIR 58A) 30ML NATURAL HDPE CYLINDER (RESIN INEOS B53-35H-011) AS MANUFACTURED IN ONTARIO CANADA LANDMARK DOSE INDICATING ACTUATOR AS MANUFACTURED IN LE VAUDREUIL FRANCE MONTELUKAST SODIUM AS MANUFACTURED IN NETANYA ISRAEL AMPACET 162805-MX MB AZUL AS MANUFACTURED IN QUERETARO MEXICO AMPACET 169181-MX MB AZUL AS MANUFACTURED IN QUERETARO MEXICO AMPACET 171921-MX MB VERDE AS MANUFACTURED IN QUERETARO MEXICO AMPACET 171920-MX MB AZUL AS MANUFACTURED IN QUERETARO MEXICO TOPOTECAN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA BUPROPION HYDROCHLORIDE AS MANUFACTURED IN KARNATAKA INDIA QUETIAPINE FUMARATE AS MANUFACTURED IN KARNATAKA INDIA STAVUDINE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA AQUABOND 444A AND AQUABOND 444D AS MANUFACTURED IN BREMEN FEDERAL REPUBLIC OF GERMANY RITONAVIR USP (FORM I) AS MANUFACTURED IN ANDHRA PRADESH INDIA PROMETHAZINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA ARIPIPRAZOLE AS MANUFACTURED IN GUJARAT INDIA DRY VITAMIN D3 50 AS MANUFACTURED IN BALLERUP DENMARK

ST GOBAIN PERFORMANCE PLASTICS CORP PHARMED BPT BIOCOMPATIBLE TUBING AS MANUFACTURED IN AKRON OHIO ST GOBAIN PERFORMANCE PLASTICS CORP TYGON S-50-HL MEDICAL/SURGICAL TUBING AS MANUFACTURED IN AKRON OHIO

Page 594

4Q2012EXCEL DMF# 19846 A 19847 I 19848 A 19849 19850 19851 I 19852 19853 19854 19855 19856 19857 19858 19859 I 19860 19861 19862 A 19863 A 19864 19865 I 19866 19867 I 19868 19869 I 19870 19871 19872 19873 A 19874 19875 19876 I 19877 I II 10/17/2006 A A III III II 10/16/2006 10/16/2006 10/16/2006 3M DRUG DELIVERY SYSTEMS 3M DRUG DELIVERY SYSTEMS ZHEJIANG XINHUA PHARMACEUTICAL CO LTD RAGACTIVES S L 3M COTRAN 9700 AS MANUFACTURED IN VALLEY NE 3M COTRAN 9767 EVA-BLEND TAPE AS MANUFACTURED IN VALLEY NE CIPROFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN VALLADOLID SPAIN A A A II II III III 10/16/2006 10/16/2006 10/9/2006 10/13/2006 TEVA PHARMACEUTICAL INDUSTRIES LTD DR REDDYS LABORATORIES LTD WACKER CHEMIE AG 3M DRUG DELIVERY SYSTEMS DIFLUPREDNATE AS MANUFACTURED IN MILANO ITALY DIVALPROEX SODIUM AS MANUFACTURED IN ANDHRA PRADESH INDIA ELASTOSIL R PLUS 400/40 AS MANUFACTURED IN BURGHAUSEN, GERMANY A III IV 10/18/2006 10/17/2006 ALUFLEXPACK NOVI D.O.O PREMIUM INGREDIENTS GROUP I II IV 10/13/2006 10/9/2006 RANBAXY LABORATORIES LTD CARGILL FLAVOR SYSTEMS US LLC A IV II 10/13/2006 10/13/2006 II 10/3/2006 ERREDUE SPA INNOVATIVE CHEMICAL AND LIFE SIEGFRIED USA LLC RANBAXY LABORATORIES LTD I A II II II 10/12/2006 10/12/2006 10/9/2006 A A A A A A A II II III III II II II II 10/10/2006 10/10/2006 6/9/2006 6/9/2006 12/6/2006 11/7/2006 11/1/2006 10/12/2006 HETERO LABS LTD HETERO DRUGS LTD ROY AND LECLAIR EMBALLAGE INC ROY AND LECLAIR EMBALLAGE INC EMCURE PHARMACEUTICALS LTD IPCA LABORATORIES LTD AURISCO PHARMACEUTICAL LTD ZHEJIANG XINHUA PHARMACEUTICAL CO LTD MATRIX LABORATORIES LTD MYLAN LABORATORIES LTD AUROBINDO PHARMA LTD A A III III II 10/6/2006 10/6/2006 10/6/2006 II 10/3/2006 JOHNSON MATTHEY PHARMACEUTICAL MATERIALS ROLLPRINT PACKAGING PRODUCTS INC ROLLPRINT PACKAGING PRODUCTS INC AUROBINDO PHARMA LTD II 10/6/2006 STATUS Type SUBMIT DATE II 10/6/2006 HOLDER JOHNSON MATTHEY PHARMACEUTICAL MATERIALS 3M DRUG DELIVERY SYSTEMS DIV SUBJECT HYDROMORPHONE HCI, USP AS MANUFACTURED IN WEST DEPTFORD, NJ

4Q2012

MAXAIR AUTOHALER (PIRBUTEROL ACETATE INHALATION AEROSOL) AS MANUFACTURED IN NORTHRIDGE CA HYDROCODONE BITARTRATE USP AS MANUFACTURED IN WEST DEPTFORD NJ RPP# 36-1223 AS MANUFACTURED IN ADDISON IL RPP# 20-0204 AS MANUFACTURED IN ADDISON IL INDINAVIR SULFATE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTERED IN ANDHRA PRADESH INDIA LOPINAVIR AS MANUFACTURED IN ANDHRA PRADESH INDIA PRAMIPEXOLE DIHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA FLAT OVAL FAMILY OF BOTTLES AS MANUFACTURED IN QUEBEC CANADA CYLINDER FAMILY OF BOTTLES AS MANUFACTURED IN QUEBEC CANADA ATAZANAVIR SULFATE AS MANUFACTURED IN MAHARASHTRA INDIA BENDROFLUMETHIAZIDE USP (ESUB) AS MANUFACTURED IN RATLAM (MP) INDIA FLUMETHASONE AS MANUFACTURED IN ZHEJIANG CHINA SPIRONOLACTONE AS MANUFACTURED IN ZHEJIANG CHINA DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA ATOMOXETINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA LOPINAVIR (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA STAVUDINE AS MANUFACTURED IN ISSO ITALY CELLULOSE ACETATE BUTYRATE NF AS MANUFACTURED IN PENNSVILLE NJ 7-AMINO-3-VINYL-3-CEPHEM-4-CARBOXYLIC ACID [7-AVCA] DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN PUNJAB INDIA CEFDINIR AS MANUFACTURED IN PUNJAB INDIA NATURAL MIXED BERRY FLAVOR WONF (125-01054) - LIQUID AS MANUFACTURED IN CINCINNATI OH BLISTER FOIL AS MANUFACTURED IN ZADAR CROATIA ARTIFICIAL MIXED BERRY FLAVOR (118A09F) AS MANUFACTURED IN WEST CHICAGO IL

3M COTRAN 9699 POLYURETHANE-POLYOLEFIN TAPE AS MANUFACTURED IN VALLEY NE

Page 595

4Q2012EXCEL DMF# 19878 19879 19880 19881 19882 19883 19884 19885 19886 19887 19888 A 19889 A 19890 19891 19892 19893 A 19894 19895 19896 19897 19898 19899 A 19900 19901 19902 19903 19904 19905 19906 19907 19908 A 19909 19910 19911 A 19912 19913 A A II II 10/26/2006 10/26/2006 A I II II II 10/28/2006 10/28/2006 10/30/2006 APTALIS PHARMATECH INC AURO LABORATORIES LTD A A A A A I A A III II II II II II III III II 10/16/2006 10/17/2006 10/20/2006 10/25/2006 10/26/2006 10/24/2006 10/24/2006 10/24/2006 10/26/2006 I A I A A II III V III II II 10/23/2006 10/24/2006 5/25/2005 10/23/2006 10/17/2006 10/16/2006 SANDOZ PRIVATE LTD MURASE GLASS CO LTD DIOSYNTH BV STELLA KUNSTSTOFFTECHNIK GMBH MALLINCKRODT INC A A A II III II II 6/2/2006 6/13/2006 10/5/2006 10/23/2006 TRIFARMA SPA AIRSEC SAS LUPIN LTD MERCK KGAA III 10/4/2006 BASF SE STATUS Type SUBMIT DATE A A A I I A A I A A III II II III II III II II III II III 10/18/2006 10/11/2006 10/17/2006 10/12/2006 10/17/2006 10/10/2006 10/14/2006 10/20/2006 10/18/2006 10/19/2006 10/4/2006 HOLDER ALPLA MEXICO SA DE CV AARTI INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD AMPACET CORP MALLINCKRODT LLC 3M DRUG DELIVERY SYSTEMS SUN PHARMACEUTICAL INDUSTRIES LTD TRACE LIFE SCIENCES INC DYNIC USA APTALIST PHARMATECH INC BASF SE SUBJECT TOOTHPASTE BOTTLE AND CAP AS MANUFACTURED IN TOLUCA MEXICO VENLAFAXINE HYDROCLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA ATORVASTATIN CALCIUM AS MANUFACTURED IN BEER SHEVA ISRAEL AMPACET 151334-K RED 334 AS MANUFACTURED IN RAYONG THAILAND AMPHETAMINE BASE CODE 6507 (ESUB) AS MANUFACTURED IN ST LOUIS MO

4Q2012

3M COTRAN 9761 POLYETHYLENE TAPE AS MANUFACTURED IN BROOKINGS SD DIVALPROEX SODIUM AS MANUFACTURED IN MAHARASHTRA INDIA SODIUM IODIDE-123-02 DRY IODINE AS MANUFACTURED IN DENTON TX SPEED WAX THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO OR EUR-1046 ORALLY DISINTEGRATING TABLETS AS MANUFACTURED IN VANDALIA OH ULTRAFORM S2320 003 PRO UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY ULTRAFORM W2320 003 PRO UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY PROCHLORPERAZINE BASE CHILD RESISTANT CLOSURE AS MANUFACTURED IN ROMORANTIN FRANCE LAMOTRIGINE (MICRONISED) AS MANUFACTURED IN MAHARASHTRA INDIA DI-POTASSIUM HYDROGEN PHOSPHATE AS MANUFACTURED IN FRANKFURTER STRASSE, GERMANY ROSIGLITAZONE MALEATE AS MANUFACTURED IN MAHARASHTRA INDIA AMPOULE VIAL AND SCREW VIAL AS MANUFACTURED IN CHIBA JAPAN DOWN STREAM PROCESSING FACILITY LOCATED IN OSS THE NETHERLANDS MEASURING CUP AS MANUFACTURED IN KASTELLAUN, GERMANY OXYCODONE BASE - CODE 8180 (ESUB) AS MANUFACTURED IN ST LOUIS MO

ZHEJIANG CHIRAL MEDICINE CHEMICALS CO CARBIDOPA AS MANUFACTURED IN ZHEJIANG CHINA LTD FARMACAP INDUSTRIA E COMERCIO LTDA RUBBER STOPPERS AS MANUFACTURED IN POTUVERA BRAZIL APOTEX PHARMACHEM INC LUPIN LTD LUPIN LTD NAVINTA LLC PT SINKONA INDONESIA LESTARI COPE ALLMAN JAYCARE LTD COPE ALLMAN JAYCARE LTD AUROBINDO PHARMA LTD PAMIDRONIC ACID AS MANUFACTURED IN ONTARIO CANADA RIFABUTIN USP AS MANUFACTURED IN MAHARASHTRA INDIA RABEPRAZOLE SODIUM (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA HYDRALAZINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA QUININE SULFATE USP AS MANUFACTURED IN WEST JAVA INDONESIA 150ML BOTTLE AS MANUFACTURED IN PORTSMOUTH HAMPSHIRE UK SAF PAK RANGE OF BOTTLES AS MANUFACTURED IN PORTSMOUTH HAMPSHIRE UK LAMOTRIGINE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA EUR-1048 ORALLY DISINTEGRATING TABLETS AS MANUFACTURED IN VANDALIA OH METFORMIN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

UNION QUIMICO FARMACEUTICA SA UQUIFA FAMOTIDINE USP AS MANUFACTURED IN BARCELONA SPAIN SA IRVINE SCIENTIFIC SALES CO FMDF-6 (KIRIN) AS MANUFACTURED IN SANTA ANA CALIFORNIA IRVINE SCIENTIFIC SALES CO KI NSM-12 (KIRIN) AS MANUFACTURED IN SANTA ANA CALIFORNIA

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4Q2012EXCEL DMF# 19914 A 19915 19916 I 19917 19918 A 19919 I 19920 19921 A 19922 A 19923 19924 19925 A 19926 19927 19928 A 19929 A 19930 A 19931 A 19932 A 19933 19934 19935 A 19936 19937 19938 19939 A 19940 A 19941 19942 A A III II 11/1/2006 11/1/2006 ULTRAAFLEX INDIA IMMUTEP SA III 11/1/2006 LORMAC INDUSTRIAL DISTRIBUTORS LTD A A A II II II III 11/6/2006 11/2/2006 10/30/2006 11/1/2006 CAMBREX CHARLES CITY INC SAVIOR LIFETEC CORP TAINAN BRANCH SAVIOR LIFETEC CORP TAINAN BRANCH LORMAC INDUSTRIAL DISTRIBUTORS LTD A A II II III 8/18/2006 11/3/2006 10/30/2006 CADILA PHARMACEUTICALS LTD CHEMI SPA AMCOR FLEXIBLES BURGDORF GMBH II 10/30/2006 AUROBINDO PHARMA LTD II 10/10/2006 III 9/20/2006 III 10/28/2006 C A II II III 11/2/2006 11/1/2006 9/20/2006 TEVA PHARMACEUTICAL INDUSTRIES LTD ACS DOBFAR SPA SHANDONG PHARMACEUTICAL GLASS CO LTD SHANDONG PHARMACEUTICAL GLASS CO LTD SHANDONG PHARMACEUTICAL GLASS CO LTD WANBURY LTD N A IV II 10/28/2006 11/20/2006 II 10/17/2006 A II II 11/2/2006 8/15/2006 II 11/1/2006 I II II 10/30/2006 10/30/2006 A II II 11/1/2006 8/31/2006 CYALUME SPECIALTY PRODUCTS INC KAIFENG PHARMACEUTICAL (GROUP) CO LTD TEVA PHARMACEUTICAL INDUSTRIES LTD HELSINN CHEMICALS SA HELSINN ADVANCED SYNTHESIS SA ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD SANDOZ PRIVATE LTD NINGBO DOUBLE SUN PHARMACEUTICAL CO LTD ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD NOT AN ASSIGNED NUMBER CHEMCAPS LTD IPCA LABORATORIES LTD STATUS Type SUBMIT DATE II 10/25/2006 HOLDER ALDRICH CHEMICAL CO ISOTEC FACILITY SUBJECT

4Q2012

CARBAMAZEPINE-13C1, 15N1 FOR CLINICAL RESEARCH AS MANUFACTURED IN MIAMISBURG, OH PRAMOXINE HYDROCHLORIDE USP AS MANUFACTURED IN BOUND BROOK, NJ GENTAMICIN SULFATE AS MANUFACTURED IN KAIFENG CHINA PANTOPRAZOLE SODIUM AS MANUFACTURED IN ZAGREB CROATIA ISOTRETINOIN AS MANUFACTURED IN BIASCA SWITZERLAND CARISOPRODOL USP AS MANUFACTURED IN ZHEJIANG CHINA ARIPIPRAZOLE AS MANUFACTURED IN MAHARASHTRA INDIA GLICLAZIDE AS MANUFACTURED IN ZHEJIANG CHINA PAROXETINE HYDROCHLORIDE (HEMIHYDRATE) AS MANUFACTURED IN ZHEJIANG CHINA

EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN RAJASTAN INDIA METFORMIN HYDROCHLORIDE USP (PROCESS-II) (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA ARIPIPRAZOLE AS MANUFACTURED IN BEER SHEVA ISRAEL CEFEPIME HYDROCHLORIDE ORAL GRADE AS MANUFACTURED IN MILANO ITALY GLASS (TYPE III) CONTAINERS FOR PARENTERAL PREPARATIONS AS MANUFACTURED IN SHANDONG CHINA GLASS (TYPE I) CONTAINERS FOR PARENTERAL PREPARATIONS AS MANUFACTURED IN SHANDONG CHINA ELASTOMERIC CLOSURES FOR PHARMA PACKAGING AS MANUFACTURING IN SHANDONG CHINA SERTRALINE HYDROCHLORIDE FORM I AS MANUFACTURED IN ANDHRA PRADESH INDIA EFAVIRENZ (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA SODIUM ALENDRONATE TRIHYDRATE AS MANUFACTURED IN PATRICA ITALY COATED PAPER 60/ALUMINIUM 8/LLDPE 50 (SOP 50158) AS MANUFACTURED IN BURGDORF SWITZERLAND CARVEDILOL AS MANUFACTURED IN CHARLES CITY IA IMIPENEM AS MANUFACTUED IN TAINAN TAIWAN CILASTATIN AS MANUFACTURED IN TAINAN TAIWAN LORMAC TYPE 1P ANTI-STATIC POLYETHYLENE PRODUCTS AS MANUFACTURED IN CO CORK IRELAND LORMAC TYPE 1X ANTI-STATIC POLYETHYLENE PRODUCTS AS MANUFACTURED IN CO CORK IRELAND PLAIN/PRINTED ALUMINIUM FOILS AS MANUFACTURED GOA INDIA IMP321 AS MANUFACTURED IN GOSSELIES BELGIUM

Page 597

4Q2012EXCEL DMF# 19943 A 19944 19945 A 19946 A 19947 19948 19949 19950 19951 I 19952 19953 A 19954 19955 19956 19957 19958 I 19959 A 19960 A 19961 19962 19963 19964 19965 19966 19967 A 19968 19969 19970 I 19971 19972 19973 19974 19975 A A A A A II II II II II 11/15/2006 11/16/2006 11/8/2006 11/3/2006 11/3/2006 SAI ADVANTIUM PHARMA LTD GRANULES INDIA LTD SARACA LABORATORIES LIMITED FIDIA FARMACEUTICI SPA FIDIA FARMACEUTICI SPA A A II III II 11/3/2006 11/14/2006 11/16/2006 A I I I A A II IV IV IV II II II 11/14/2006 11/13/2006 11/13/2006 11/13/2006 11/10/2006 11/15/2006 11/15/2006 II 11/14/2006 ORCHID CHEMICALS AND PHARMACEUTICALS LTD DR REDDYS LABORATORIES LTD FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FARCHEMIA SRL UBE INDUSTRIES LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD JUBILANT LIFE SCIENCES LTD PHILLIPS 66 DR REDDYS LABORATORIES LTD II 11/7/2006 AUROBINDO PHARMA LTD A I A A IV III II II III 10/30/2006 10/30/2006 11/4/2006 11/13/2006 11/14/2006 I IV III 11/7/2006 11/13/2006 A A A A II II II III II 11/8/2006 11/1/2006 11/6/2006 11/9/2006 11/2/2006 IV 7/26/2006 HENRY H OTTENS MANUFACTURING COMPANY INC TARO PHARMACEUTICAL INDUSTRIES LTD YUNG ZIP CHEMICAL IND CO LTD SUN PHARMACEUTICAL INDUSTRIES LTD SCHOTT BRASIL LTDA JIANGSU TASLY DIYI PHARMACEUTICAL CO LTD BIO CIDE INTERNATIONAL INC INYECCIONES PLASTICAS DE QUERETARO SA DE CV FREUND CORP REXAM PHARMA SAS IND SWIFT LABORATORIES LTD APOTEX PHARMACHEM INC ARTE CORP A V III 11/7/2006 11/2/2006 CELSIS INC AMPACET CORP STATUS Type SUBMIT DATE II 11/8/2006 HOLDER CATALENT PHARMA SOLUTIONS SUBJECT MICONAZOLE GELATIN ENCAPSULATED VAGINAL SUPPOSITORY 200 MG AS MANUFACTURED IN SOMERSET NJ CELSIS AKUSCREEN AS MANUFACTURED IN LANDGRAAF THE NETHERLANDS

4Q2012

AMPACET PRODUCT 112147 WHITE POLYETHYLENE AS MANUFACTURED IN TERRE HAUTE IN NATURAL BANANA FLAVOR WONF #8763 AS MANUFACTURED IN PHILADELPHIA PA GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN HAIFA BAY ISRAEL ACYCLOVIR (PROCESS II) AS MANUFACTURED IN TACHIA TAIWAN ARIPIPRAZOLE AS MANUFACTURED IN GUJARAT INDIA GLASS PRODUCTS AS MANUFACTURED IN ITUPEVA SP BRAZIL FLUTAMIDE AS MANUFACTURED IN JIANGSU CHINA SODIUM CHLORITE EXCIPIENT INGREDIENT AS MANUFACTURED IN NORMAN OK PET INJECTED FLAVOR BARRIER INSERT AND HDPE INJECTED SHOULDER FOR TOOTHPASTE BOTTLE AS MANUFACTURED IN MEXICO CITY MEXICO NONPAREIL-108 AS MANUFACTURED IN HAMAMATSU CITY JAPAN SEABISCUIT RANGE AS MANUFACTURED IN OFFRANVILLE FRANCE DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN PUNJAB INDIA ARIPIPRAZOLE AS MANUFACTURED IN ONTARIO CANADA SINGLE CHAMBER PREFILLABLE SYRINGE AS MANUFACTURED IN TAKAHAGI CITY JAPAN DOXAZOSIN MESYLATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA CEFIXIME AS MANUFACTURED IN KANCHEEPURAM INDIA ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA 825.609 N-C CHERRY BERRY FLAVOR ARTIFICIAL AS MANUFACTURED IN GENEVA IL 935.195 N-C COOLING FLAVOR, NATURAL AS MANUFACTURED IN GENEVA IL 848.0001U N-C EUCALYPTUS FLAVOR NATURAL AS MANUFACTURED IN GENEVA IL TRIMETHOBENZAMIDE HCI AS MANUFACTURED IN BERGAMO ITALY BEPOTASTINE BESILATE (ESUB) AS MANUFACTURED IN UBE YAMAGUCHI JAPAN GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA RISEDRONATE SODIUM AS MANUFACTURED IN KARNATAKA INDIA POLYPROPYLENE HOMOPOLYMER CH200LN-02 AS MANUFACTURED IN LINDEN NJ PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA EPOPROSTENOL SODIUM AS MANUFACTURED IN ANDHRA PRADESH INDIA COMPRESSO PAP 90 CPC AS MANUFACTURED IN AP INDIA RANITIDINE HCI (FORM-I) AS MANUFACTURED IN HYDERABAD INDIA DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN MILANO ITALY FUROSEMIDE AS MANUFACTURED IN MULAZZANO (LO) ITALY

Page 598

4Q2012EXCEL DMF# 19976 19977 19978 19979 19980 A 19981 19982 19983 A 19984 19985 19986 19987 19988 19989 19990 19991 19992 A 19993 19994 19995 A 19996 19997 19998 A 19999 20000 20001 I 20002 I 20003 A 20004 A 20005 A 20006 A 20007 20008 A A II II 11/30/2006 12/1/2006 DR REDDYS LABORATORIES LTD DR REDDYS LABORATORIES LTD II 11/30/2006 SCORA SA III 11/22/2006 COLORS FOR PLASTICS INC II 11/30/2006 GADOR SA II 11/29/2006 II 11/23/2006 I A II III II 11/21/2006 9/21/2006 11/23/2006 WANBURY LTD THE CONTROL GROUP PALL BIOSEPRA DIVISION OF PALL FRANCE SA PALL BIOSEPRA DIVISION OF PALL FRANCE SA CIPLA LTD A A II II II 11/27/2006 11/27/2006 11/17/2006 A I II III II 11/20/2006 11/17/2006 11/24/2006 FARCHEMIA SRL RICON COLORS INC LABORATORIO CHIMICO INTERNAZIONALE SPA DR REDDYS LABORATORIES LTD DR REDDYS LABORATORIES LTD AUROBINDO PHARMA LTD A A A A A A A A II II II II II II II II III 11/17/2006 10/19/2006 11/15/2006 11/22/2006 11/22/2006 11/23/2006 11/22/2006 11/22/2006 11/13/2006 NEULAND LABORATORIES LTD M/S MARKSANS PHARMA LIMITED WANBURY LTD CIPLA LTD HETERO LABS LTD ITF CHEMICAL LTDA DR REDDYS LABORATORIES LTD MOEHS IBERICA SL AMPACET CORP A A II II II 11/17/2006 10/10/2006 11/16/2006 STATUS Type SUBMIT DATE A A A A III III II II II 11/15/2006 11/13/2006 12/13/2006 11/20/2006 10/10/2006 HOLDER PPG INDUSTRIES INC ASHLAND INC STREM CHEMICALS INC LEK PHARMACEUTICALS DD SUBJECT PPG2004877 AS MANUFACTURED IN OAK CREEK WI FLEXCRYL AF2027 AS MANUFACTURED IN PIEDMONT SC FOMEPIZOLE AS MANUFACTURED IN NEWBURYPORT MA FOR CHEMWERTH TACROLIMUS AS MANUFACTURED IN MENGES SLOVENIA

4Q2012

CHANGZHOU SIYAO PHARMACEUTICALS CO FLUOXETINE HYDROCHLORIDE AS MANUFACTURED IN JIANGSU CHINA LTD HOVIONE FARMACIENCIA SA FLUMETHASONE AS MANUFACTURED IN LOURES PORTUGAL TAI HENG INDUSTRY CO LTD AUROBINDO PHARMA LTD ARIPIPRAZOLE AS MANUFACTURED IN ZHEJIANG CHINA CEPHALOTHIN ACID (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN ANDHRA PRADESH INDIA ENALAPRIL MALEATE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA METFORMIN HYDROCHLORIDE USP AS MANUFACTURED IN PUNE INDIA DIPHENHYDRAMINE CITRATE AS MANUFACTURED IN MAHARASHTRA INDIA TELMISARTAN (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA LOSARTAN POTASSIUM (FORM 1) AS MANUFACTURED IN ANDHRA PRADESH INDIA ROSIGLITAZONE MALEATE AS MANUFACTURED IN BAHI BRAZIL CANDESARTAN CILEXETIL AS MANUFACTURED IN ANDHRA PRADESH INDIA MEPIVACAINE HYDROCHLORIDE AS MANUFACTURED IN BARCELONA SPAIN AMPACET 163058 DARK BLUE POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE IN MESALAZINE HIGH DENSITY AS MANUFACTURED IN BERGAMO ITALY BLUE REFLEX FDA CPP-BL-3578-1 AS MANUFACTURED IN WEST CHICAGO IL FENOFIBRIC ACID AS MANUFACTURED IN MILAN ITALY VORICONAZOLE AS MANUFACTURED IN ANDHRA PRADESH INDIA ATORVASTATIN CALCIUM (FORM P) AS MANUFACTURED IN ANDHRA PRADESH INDIA CEFTAZIDIME FOR INJECTION USP (STERILE BULK) AS MANUFACTURED IN ANDHRA PRADESH INDIA IBUPROFEN DC GRADE-65% AS MANUFACTURED IN MAHARASHTRA INDIA LAMINATED AND PRINTED PACKAGING FILMS AS MANUFACTURED IN NORWOOD NJ BIOSEPRA PPAHYPERCEL SORBENT AS MANUFACTURED IN ST PIERRE LES ELBEUF FRANCE BIOSEPRA HEA HYPERCEL AS MANUFACTURED IN ST PIERRE LES ELBEUF FRANCE TENOFOVIR DISOPROXIL FUMARATE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA 18-METHYLNORETHINDRONE OXIME (NORELGESTROMIN) AS MANUFACTURED IN BUENOS AIRES ARGENTINA THERMOPLASTIC RESIN COLORANT MASTERBATCH W04200 AS MANUFACTURED IN ELK GROVE VILLAGE IL SCORALITE AND SCORALITE LOW LEAD CALCIUM CARBONATE AS MANUFACTURED IN CAFFIERS FRANCE PRIMIDONE AS MANUFACTURED IN ANDHRA PRADESH INDIA IRBESARTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA

Page 599

4Q2012EXCEL DMF# 20009 A 20010 20011 A 20012 20013 20014 I 20015 20016 20017 20018 20019 20020 20021 20022 A 20023 20024 20025 20026 20027 20028 I 20029 A 20030 20031 A 20032 20033 A 20034 20035 20036 20037 20038 20039 20040 20041 20042 20043 A A A A A A A C A I II II II II II II II II III II 12/14/2006 12/14/2006 12/14/2006 12/19/2006 12/11/2006 12/13/2006 12/12/2006 12/14/2006 11/24/2006 12/11/2006 A II II 12/7/2006 12/13/2006 FIS FABBRICA ITALIANA SINTETICI SPA HERAEUS PRECIOUS METALS GMBH AND CO KG ANJAN DRUG PRIVATE LTD DR REDDYS LABORATORIES LTD ANJAN DRUG PRIVATE LTD IPCA LABORATORIES LTD WANBURY LTD TEVA PHARMACEUTICAL INDUSTRIES LTD MERCK AND CIE TEVA PHARMACEUTICAL INDUSTRIES LTD AMCOR FLEXIBLES HORSENS WANBURY LTD A III II 12/6/2006 12/4/2006 ROHM AND HAAS CO AUROBINDO PHARMA LTD II 12/10/2006 A A I N A III III 12/4/2006 11/27/2006 II III II 11/21/2006 11/21/2006 10/31/2006 ALEMBIC PHARMACEUTICALS LTD APEX PLASTICS INC STANDARD CHEM AND PHARM CO LTD NOT AN ASSIGNED NUMBER NATIONAL PLASTICS COLOR INC BERRY PLASTICS CORP TAPES AND COATINGS DIV NOF CORP COLORANT AS MANUFACTURED IN VALLEY CENTER KS MS-H-2530SR AS MANUFACTURED IN HOMER LA C A A A A I A II III III III III II II II 12/5/2006 11/28/2006 11/26/2006 11/25/2006 11/25/2006 12/9/2006 12/8/2006 12/8/2006 N A II II 11/24/2006 12/5/2006 NOT AN ASSIGNED NUMBER JUBILANT LIFE SCIENCES LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD HETERO LABS LTD POLYONE CORP STYROLUTION GMBH ISHAN INDUSTRIES ISHAN INDUSTRIES SANMAR SPECIALITY CHEMICALS LTD SCINOPHARM TAIWAN LTD SIEMENS MOLECULAR IMAGING A II II 11/30/2006 11/29/2006 INDUSTRIALE CHIMICA SRL APICORE LLC BUDESONIDE USP AS MANUFACTURED IN SARONNO ITALY STATUS Type SUBMIT DATE II 11/30/2006 HOLDER SUBJECT

4Q2012

PHARMACEUTICAL WORKS POLPHARMA SA SULFADIMETHOXINE SODIUM AS MANUFACTURED IN STAROGARD GDANSKI POLAND

PHENOXYBENZAMINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN SOMERSET, NJ

CITALOPRAM HYDROBROMIDE (DGR) AS MANUFACTURED IN KARNATAKA INDIA AZTREONAM AS MANUFACTURED IN MAHARASHTRA INDIA EFAVIRENZ(PROCESS I) AS MANUFACTURED IN ANDHRA PRADESH INDIA CC00001986DR 10031450 ALCOA WHITE AS MANUFACTURED IN VONORE TN TERLUX 2812 HD AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY PET BOTTLES AS MANUFACTURED IN SILVASSA INDIA COLLAPSIBLE ALUMINIUM TUBES AS MANUFACTURED IN SILVASSA INDIA LETROZOLE USP AS MANUFACTURED IN TAMIL NADU INDIA DOCETAXEL AS MANUFACTURED IN TAINAN TAIWAN STERILE NON-PYROGENIC 3'-DEOXY-3'-[18F]FLUOROTHYMIDINE ([18F]FLT) AS MANUFACTURED IN CULVER CITY CA CLARITHROMYCIN USP AS MANUFACTURED IN GUJARAT INDIA PACKAGING BLOW MOLDED BOTTLE AS MANUFACTURED IN BROOKFIELD MO TERAZOSIN HYDROCHLORIDE AS MANUFACTURED IN TAINAN TAIWAN

METHOXYPOLY(ETHYLENE GLYCOL)-PROPYLALDEHYDE MW20000 AS MANUFACTURED IN KANAGAWA JAPAN ROBOND PS-8136 AS MANUFACTURED IN CROYDON PA ALENDRONATE SODIUM USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA FIS0127 AS MANUFACTURED IN VICENZA ITALY ARSENIC TRIOXIDE USP AS MANUFACTURED IN HANAU, GERMANY VALPROIC ACID AS MANUFACTURED IN TAMIL NADU INDIA MONTELUKAST SODIUM AS MANUFACTURED IN ANDHRA PRADESH INDIA DIVALPROEX SODIUM AS MANUFACTURED IN TAMIL NADU INDIA GLIMEPIRIDE USP (ESUB) AS MANUFACTURED IN RATLAM (MP) INDIA METHOXSALEN AS MANUFACTURED IN ANDHRA PRADESH INDIA EZETIMIBE AS MANUFACTURED IN BEER SHEVA ISRAEL L-METHYLFOLATE CALCIUM AS MANUFACTURED IN SCHAFFHAUSEN SWITZERLAND MUPIROCIN CALCIUM AS MANUFACTURED IN HUNGARY PETP12/ALU7/PETP12/LLDPE60 AS MANUFACTURED IN HORSENS DENMARK IBUPROFEN DC GRADE-90% AS MANUFACTURED IN MAHARASHTRA INDIA

Page 600

4Q2012EXCEL DMF# 20044 20045 20046 20047 A 20048 A 20049 20050 I 20051 20052 20053 20054 C 20055 20056 20057 20058 20059 20060 20061 A 20062 20063 20064 20065 20066 A 20067 20068 20069 20070 20071 20072 20073 20074 I 20075 20076 20077 A 20078 A V 12/20/2006 BIOPHARMA SRL A A II II II 12/22/2006 12/26/2006 11/9/2006 A C C A A C A II II II II II II II II 12/14/2006 12/20/2006 12/20/2006 5/18/2007 5/15/2007 12/20/2006 12/20/2006 12/18/2006 RANBAXY LABORATORIES LTD TEVA PHARMACEUTICALS INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD APOTEX PHARMACHEM INC WOCKHARDT LTD TEVA PHARMACEUTICAL INDUSTRIES LTD CHEMPACIFIC CORP SHIJIAZHUANG PHARMACEUTICAL GROUP HUASHENG PHARMA CO LTD RANBAXY LABORATORIES LTD SANDOZ GMBH KYONGBO PHARMACEUTICAL CO LTD I I A A II II II III II 12/8/2006 12/13/2006 12/13/2006 12/14/2006 12/21/2006 I I I I A A II IV IV II II II II 12/8/2006 12/19/2006 12/19/2006 5/31/2006 12/19/2006 11/23/2006 12/19/2006 A A A II II II II 12/14/2006 12/16/2006 12/18/2006 12/19/2006 AARTI DRUGS LTD JUBILANT LIFE SCIENCES LTD LEK PHARMACEUTICALS DD HERAEUS PRECIOUS METALS GMBH AND CO KG SAI PHYTOCEUTICALS PVT LTD FONA INTERNATIONAL INC FONA INTERNATIONAL INC TRACE LIFE SCIENCES INC NV ORGANON S M HERBALS PVT LTD CHONGQING DAXIN PHARMACEUTICAL CO LTD SAI PHYTOCEUTICALS PVT LTD WATSON PHARMA PRIVATE LTD WATSON PHARMA PRIVATE LTD POLYONE CORP CILAG AG A III III 6/26/2006 12/15/2006 EMS CHEMIE NORTH AMERICA INC STELLA KUNSTSTOFFTECHNIK GMBH II 12/16/2006 RANBAXY LABORATORIES LTD STATUS Type SUBMIT DATE A A A III II II II 12/14/2006 12/15/2006 12/16/2006 12/16/2006 HOLDER COPE ALLMAN JAYCARE LTD SANDOZ PRIVATE LTD RANBAXY LABORATORIES LTD RANBAXY LABORATORIES LTD SUBJECT PUSH-LOK RANGE OF CLOSURES AS MANUFACTURED IN HAMPSHIRE UK QUETIAPINE FUMARATE AS MANUFACTURED IN MAHARASHTRA INDIA CILASTATIN ACID AS MANUFACTURED IN MADHYA PRADESH INDIA

4Q2012

BICYCLOKETONE DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN PUNJAB INDIA IMIPENEM TECHNICAL DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN MADHYA PRADESH INDIA GRILFLEX ELG 5930 NATURAL AS MANUFACTURED IN DOMAT/EMS SWITZERLAND PRIMARY PACKAGE CONSISTING OF BOTTLE, PLUG AND BRUSH CLOSURE AS MANUFACTURED IN NIACIN AS MANUFACTURED IN MAHARASHTRA INDIA ZOLEDRONIC ACID AS MANUFACTURED IN MYSORE INDIA CANDESARTAN CILEXETIL AS MANUFACTURED IN MENGES SLOVENIA OXALIPLATIN PROCESS HER-2 USP AS MANUFACTURED IN HANAU, GERMANY CAMPTOTHECIN AS MANUFACTURED IN MADHYA PRADESH INDIA 833.046 NATURAL COFFEE CONCENTRATE AS MANUFACTURED IN GENEVA IL 807.002 NAT. MIXED BERRY FLAVOR WONF AS MANUFACTURED IN GENEVA IL INDIUM CHLORIDE (111-IN) RADIOCHEMICAL AS MANUFACTURED DENTON TX VECURONIUM BROMIDE AS MANUFACTURED IN AB OSS THE NETHERLANDS CAMPTOTHECIN [CAS NO. 7689-03-4] AS MANUFACTURED IN RAJASTHAN INDIA LOVASTATIN AS MANUFACTURED IN CHONGQING CHINA 10-DEACETYL BACCATIN-III AS MANUFACTURED IN MADHYA PRADESH INDIA TAZAROTENE AS MANUFACTURED IN MAHARASHTRA INDIA ADAPALENE AS MANUFACTURED IN MAHARASHTRA INDIA VC1000388260 GEON XV3432 TRANS 9000 AS MANUFACTURED IN AVON LAKE OH ALCAFTADINE DRUG SUBSTANCE AS MANUFACTURED IN SCHAFFHAUSEN SWITZERLAND LAMIVUDINE USP AS MANUFACTURED IN PUNJAB INDIA ROCURONIUM BROMIDE AS MANUFACTURED IN LERMA MEXICO ATORVASTATIN CALCIUM AS MANUFACTURED IN BEER SHEVA ISRAEL ATOMOXETINE HYDROCHLORIDE AS MANUFACTURED IN BRANTFORD ON CANADA ADENOSINE USP AS MANUFACTURED IN GUJARAT INDIA MYCOPHENOLATE MOFETIL AS MANUFACTURED IN DEBRECEN HUNGARY MELPHALAN DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE MD AZITHROMYCIN USP (API) AS MANUFACTURED IN SHIJIAZHUANG CHINA VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN PUNJAB INDIA CEFPODOXIME PROXETIL AS MANUFACTURED IN KUNDL AUSTRIA CEFTRIAXONE SODIUM STERILE BULK AS MANUFACTURED IN CHUNGCHEONG NAM DO KOREA BIOPHARMA SRL MANUFACTURING IN ROMA ITALY

Page 601

4Q2012EXCEL DMF# 20079 A 20080 20081 A 20082 20083 20084 20085 I 20086 20087 20088 I 20089 20090 A 20091 A 20092 I 20093 20094 I 20095 20096 20097 20098 20099 20100 20101 A 20102 I 20103 20104 20105 20106 20107 20108 20109 20110 20111 A I A I A A A A A II II II II II II II II III 12/29/2006 12/28/2006 12/27/2006 12/27/2006 1/2/2007 1/3/2007 1/3/2007 1/4/2007 1/2/2007 II 11/29/2006 NORTHEAST GENERAL PHARMACEUTICAL FACTORY CAMBREX CHARLES CITY INC AGNO PHARMA USA AMINO CHEMICALS LTD AMINO CHEMICALS LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD SMS PHARMACEUTICALS LTD WACKER CHEMICAL CORP A A A A A A II II II II II II II 12/23/2006 12/28/2006 12/27/2006 12/28/2006 12/28/2006 12/29/2006 12/29/2006 A II II 12/21/2006 12/6/2006 III 12/26/2006 II 12/27/2006 RANBAXY LABORATORIES LTD A II II 12/27/2006 12/27/2006 RANBAXY LABORATORIES LTD RANBAXY LABORATORIES LTD A I II II II 12/27/2006 12/27/2006 12/27/2006 A A A II III IV II 12/21/2006 12/22/2006 12/22/2006 12/21/2006 A III II 12/20/2006 10/17/2006 STATUS Type SUBMIT DATE II 12/22/2006 HOLDER CARDINAL HEALTH 414 LLC CARDINAL HEALTH NUCLEAR PHARMACY SERVICES 3M DRUG DELIVERY SYSTEMS ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD SYNTHON BV SRC MEDICAL INC FUJI CHEMICAL INDUSTRY CO LTD ZHEJIANG XINHUA PHARMACEUTICAL CO LTD RANBAXY LABORATORIES LTD RANBAXY LABORATORIES LTD RANBAXY LABORATORIES LTD SUBJECT

4Q2012

TETRAKIS (2-METHOXYISOBUTYLISONITRILE) COPPER (I) TETRAFLUOROBORATE DRUG SUBSTANCE AS MANUFACTURED IN DUDLEY CRAMLINGTON UK SCOTHCHPAK 9748 RELEASE LINER AS MANUFACTURED IN ZWIJNDRECHT BELGIUM ESCITALOPRAM OXALATE AS MANUFACTURED IN ZHEJIANG CHINA TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN PRAGUE CZECH REPUBLIC DROPPER ASSEMBLIES AS MANUFACTURED IN HANOVER MA F-MELT TYPE C (EXCIPIENT) AS MANUFACTURED IN TOYAMA JAPAN BUPROPION HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA IMIPENEM USP (STERILE) AS MANUFACTURED IN MADHYA PRADESH INDIA STAVUDINE USP AS MANUFACTURED IN PUNJAB INDIA NEVIRAPINE USP (ANHYDROUS) (NON-STERILE BULK) DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB INDIA CILASTATIN SODIUM USP (STERILE) AS MANUFACTURED IN MADHYA PRADESH INDIA SODIUM BICARBONATE USP (STERILE) AS MANUFACTURED IN MADHYA PRADESH INDIA

CANDESARTAN CILEXETIL (NON STERILE BULK) DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB INDIA KUNSTSTOFFWERK KREMSMUNSTER GMBH PP 28 CHILD RESISTANT TAMPER EVIDENT SCREW CAPS AS MANUFACTURED IN KREMSMUNSTER AUSTRIA AMINO CHEMICALS LTD TOLTERODINE TARTRATE AS MANUFACTURED IN MARSA MALTA JIANGSU JIWA RINTECH PHARMACEUTICAL CO LTD WOCKHARDT LTD UQUIFA MEXICO SA DE CV AARTI INDUSTRIES LTD EMERALD KALAMA CHEMICAL LLC FRESENIUS KABI ONCOLOGY LTD DR REDDYS LABORATORIES LTD JOHNSON MATTHEY PHARMACEUTICAL MATERIALS CITALOPRAM HYDROBROMIDE USP AS MANUFACTURED IN JIANGSU CHINA TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA TOLTERODINE TARTRATE AS MANUFACTURED IN MORELOS MEXICO BENAZEPRIL HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA BENZYL ALCOHOL NF-API AS MANUFACTURED IN KALAMA WA BICALUTAMIDE (ESUB) AS MANUFACTURED IN WEST BENGAL INDIA ALENDRONATE SODIUM AS MANUFACTURED IN ANDHRA PRADESH INDIA 2-(1-AMINO-1-METHYL-ETHYL)-HYDROXY-1-METHYL-6-OXO-1,6-DIHYDROPYRIMIDINE-4CARBOXYLIC ACID 4-FLUORO-BENZYLAMIDE (ECB) AS MANUFACTURED IN CONSHOHOCKEN PA LEVOCARNITINE AS MANUFACTURED IN LIAONING CHINA MMB4 DIMESYLATE AS MANUFACTURED IN CHARLES CITY IA SULINDAC AS MANUFACTURED IN JIANGSU CHINA ZIPRASIDONE HYDROCHLORIDE ANHYDROUS AS MANUFACTURED IN MARSA MALTA ADAPALENE AS MANUFACTURED IN MARSA MALTA STAVUDINE USP (STM) AS MANUFACTURED IN ANDHRA PRADESH INDIA TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN ANDHRA PRADESH INDIA TELMISARTAN USP AS MANUFACTURED IN ANDHRA PRADESH INDIA ZOLMITRIPTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA VINNOL H 40/43 AS MANUFACTURED IN BURGHAUSEN, GERMANY

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4Q2012EXCEL DMF# 20112 20113 A 20114 20115 20116 A 20117 20118 20119 A 20120 20121 A 20122 A 20123 20124 20125 A 20126 20127 20128 20129 20130 A 20131 A 20132 A 20133 20134 20135 20136 I 20137 A 20138 20139 20140 A 20141 20142 20143 A A A II II III 1/16/2007 1/10/2007 1/12/2007 I A III IV II 1/2/2007 1/9/2007 1/11/2007 II 12/14/2006 N A A IV II II 12/4/2006 1/11/2007 1/2/2007 NOT AN ASSIGNED NUMBER ROHM AND HAAS CO CODY LABORATORIES INC LOTUS PHARMACEUTICAL CO LTD RODERM MD-153 RUBBER ADHESIVE AS MANUFACTURED IN PIEDMONT SC PHENTERMINE RESIN - API AS MANUFACTURED IN CODY WY III 12/27/2006 EXECHON V 1/9/2007 COLORCON INC A A I A II II II II II 11/16/2006 1/9/2007 12/30/2006 1/11/2007 1/8/2007 PCI SYNTHESIS DR REDDYS LABORATORIES LTD AUROBINDO PHARMA LTD APOTEX PHARMACHEM INC CADILA HEALTHCARE LTD DISULFIRAM USP AS MANUFACTURED IN NEWBURYPORT MA C I II II II 1/8/2007 1/7/2007 1/8/2007 FERTIN PHARMA AS DIVIS LABORATORIES LTD CADILA HEALTHCARE LIMITED II 12/27/2006 AUROBINDO PHARMA LTD A II II 12/11/2006 1/9/2007 A A II II II 12/15/2006 12/19/2006 1/5/2007 APOTEX PHARMACHEM INC SANOFI AVENTIS DEUTSCHLAND GMBH ORCHID CHEMICALS AND PHARMACEUTICALS LTD TAIWAN BIOTECH CO LTD UNIMARK REMEDIES LTD A A II IV II 1/4/2007 12/15/2006 1/3/2007 UQUIFA ITALIA SPA CRODA INC CHEMAGIS LTD STATUS Type SUBMIT DATE A II II 1/3/2007 12/30/2006 HOLDER MYLAN LABORATORIES LTD AUROBINDO PHARMA LTD SUBJECT AMLODIPINE BESYLATE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA TERAZOSIN HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA PYRANTEL TARTRATE ZEOLEX AS MANUFACTURED IN MILAN ITALY TWEEN 80 HP-LQ-(MH) AS MANUFACTURED IN MILL HALL PA

4Q2012

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN BEER SHEVA ISRAEL ATORVASTATIN CALCIUM GRANULATION AS MANUFACTURED IN ONTARIO CANADA ARTICAINE HYDROCHLORIDE AS MANUFACTURED IN FRANKFURT, GERMANY CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA BISOPROLOL FUMARATE AS MANUFACTURED IN TAOYUAN CHINA 7-AMINO-3-CHLORO-3-CEPHEM-4-CARBOXYLIC ACID (7ACCA) AS MANUFACTURED IN GUJARAT INDIA GABAPENTIN USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA NICOTINE POLACRILEX USP AS MANUFACTURED IN VEJLE DENMARK TPE ALCOHOL AS MANUFACTURED IN ANDHRA PRADESH INDIA SIMVASTATIN ( LOVASTATIN ROUTE) AS MANUFACTURED IN VADODARA, GUJARAT, INDIA

RANITIDINE HYDROCHLORIDE (FORM-2) AS MANUFACTURE IN ANDHRA PRADESH INDIA AMOXICILLIN SODIUM (STERILE) BULK AS MANUFACTURED IN ANDHRA PRADESH INDIA LAMOTRIGINE AS MANUFACTURED IN ANDHRA PRADESH INDIA PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN GUJARAT INDIA SUPPLEMENTARY INFORMATION FOR COLORCON PRODUCT STARCAP 1500 COPROCESSED STARCH EXCIPIENT AS MANUFACTURED IN GREENVILLE IL PACKAGING MATERIALS (CONTAINERS & CLOSURES FOR SOLID ORAL DOSAGE FORMS) AS MANUFACTURED IN GUJARAT INDIA

TM-1 (N-[2-(2-METHOXYPHENOXY)ETHYL]NORGLAUCINE) AS MANUFACTURED IN TAOYUAN TAIWAN CALYX CHEMICALS AND PHARMACEUTICALS ERYTHROMYCIN AS MANUFACTURED IN MAHARASHTRA INDIA LTD SUMMIT PACKAGING SYSTEMS INC STANDARD TOTTLE CLOSURE AS MANUFACTURED IN MANCHESTER NH COREL PHARMACHEM ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD DR REDDYS LABORATORIES LTD JOHNSON MATTHEY PHARMA SERVICES NIPPON FOIL MFG CO LTD ACRYPOL CARBOMER AS MANUFACTURED IN MEHSANA (NG) INDIA ECCPA DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN ZHEJIANG CHINA ANASTROZOLE AS MANUFACTURED IN ANDHRA PRADESH INDIA LEVALBUTEROL HCI AS MANUFACTURED IN DEVENS MA ALU/ALU LAMINATED FOIL AS MANUFACTURED IN SHIGA JAPAN

Page 603

4Q2012EXCEL DMF# 20144 20145 20146 20147 A 20148 20149 A 20150 I 20151 20152 20153 20154 20155 20156 A 20157 A 20158 20159 A 20160 20161 20162 20163 20164 20165 A 20166 20167 20168 20169 20170 A 20171 20172 20173 A 20174 20175 20176 20177 N A I N II II 6/26/2008 12/3/2008 NOT AN ASSIGNED NUMBER CIPLA LTD CIPLA LTD NOT AN ASSIGNED NUMBER LETROZOLE USP (ESUB) AS MANUFACTURED IN BANGALORE, INDIA IRBESARTAN (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA A A II II II 12/20/2007 4/24/2008 1/17/2007 CIPLA LTD CIPLA LTD CIPLA LTD N N A A II II II 3/13/2008 1/17/2007 7/31/2008 NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER CIPLA LTD CIPLA LTD CIPLA LTD OXALIPLATIN PH. EUR. (ESUB) AS MANUFACTURED IN BANGALORE, INDIA OMEPRAZOLE SODIUM (ESUB) AS MANUFACTURED IN BANGALORE, INDIA N I A A A II II II II II 1/17/2007 3/16/2007 1/17/2007 1/17/2007 9/6/2007 NOT AN ASSIGNED NUMBER CIPLA LTD CIPLA LTD CIPLA LTD CIPLA LTD CIPLA LTD I II II 2/19/2009 6/29/2007 III 1/11/2007 A A A A A II II III III III IV 4/2/2007 1/5/2007 1/17/2007 1/4/2007 1/4/2007 1/12/2007 II 1/9/2007 ZHEJIANG LIAOYUAN PHARMACEUTICALS CO LTD TAI HENG INDUSTRY CO LTD JUBILANT LIFE SCIENCES LTD MEGA PUMPS LP COIM USA INC BERRY PLASTICS CORP A II II 1/12/2007 1/12/2007 USV LIMITED SANMAR SPECIALITY CHEMICALS LTD STATUS Type SUBMIT DATE A A A II III II II 1/12/2007 1/9/2007 1/4/2007 12/31/2006 HOLDER ZERIA PHARMACEUTICAL CO LTD ENALTEC LABS PVT LTD CENWAY PHARMACEUTICALS LTD BIO TECHNOLOGY GENERAL (ISRAEL) LTD SUBJECT ACOTIAMIDE HYDROCHLORIDE AS MANUFACTURED IN TOYAMA JAPAN

4Q2012

NEUTRAL GLASS SILICONISED VIALS AS MANUFACTURED IN NANI DAMAN INDIA GCLE (NON-STERILE, BULK FORM) AS MANUFACTURED IN TIANJIN CHINA SOMATROPIN (RECOMBINANT HUMAN GROWTH HORMONE) API AS MANUFACTURED IN BE'ER TUVIA, ISRAEL IRBESARTAN USP AS MANUFACTURED IN MAHARASHTRA INDIA COLCHICINE USP NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN TAMIL NADU INDIA 1-(3-HYDROXYMETHYLPYRIDYL-2)-2-PHENYL-4-METHYLPIPERAZINE (M3 INTERMEDIATE FOR MIRTAZAPINE) AS MANUFACTURED IN ZHEJIANG CHINA MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN KARNATAKA INDIA STANDARD AND MINI PUMP DISPENSERS AS MANUFACTURED IN EATONTOWN NJ PRIMER PR-109 AS MANUFACTURED IN OFFANENGO ITALY PRODUCT 60119-21 AS MANUFACTURED IN COLUMBUS GA

HENRY H OTTENS MANUFACTURING CO INC NATURAL AND ARTIFICIAL MINT FLAVOR #8985-B AS MANUFACTURED IN PHILADELPHIA PA AMCOR FLEXIBLES BURGDORF GMBH COATED PAPER 50/ALUMINIUM 9/PAN-BAREX 28 (SOP 50911) AS MANUFACTURED IN BURGDORF SWITZERLAND CIPLA LTD VINORELBINE TARTRATE USP (ESUB) AS MANUFACTURED IN BANGALORE, INDIA CIPLA LTD VENLAFAXINE HYDROCHLORIDE FORM B (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA SIBUTRAMINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA RISEDRONATE SODIUM (ESUB) AS MANUFACTURED IN PUNE INDIA RALOXIFENE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA QUETIAPINE FUMERATE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA PERINDOPRIL ERBUMINE MONOHYDRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA

MOXIFLOXACIN HYDROCHLORIDE PH. EUR. (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA MOMETHASONE FUROATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA LUMEFANTRINE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA LEVOCETIRIZINE DIHYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA

Page 604

4Q2012EXCEL DMF# 20178 A 20179 20180 20181 20182 A 20183 20184 20185 20186 A 20187 20188 20189 20190 20191 20192 20193 A 20194 20195 A 20196 20197 A 20198 20199 20200 20201 20202 20203 A 20204 20205 20206 A 20207 20208 A 20209 I 20210 A II 1/23/2007 II 1/5/2007 A II II 1/16/2007 1/18/2007 A A II II II 1/23/2007 1/24/2007 1/23/2007 A A A A A II II III III III II 1/19/2007 1/18/2007 1/18/2007 1/5/2007 1/15/2007 1/12/2007 A II V 1/16/2007 1/22/2007 EMCURE PHARMACEUTICALS LTD NOVO NORDISK PHARMACEUTICAL INDUSTRIES INC LUPIN LTD INDUSTRIALE CHIMICA SRL 3M CO 3M CO IMPRESS CONTAINERS CO ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD TONIRA PHARMA LTD AMINO CHEMICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD BIOCON LTD ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD CHANGZHOU KANGPU PHARMACEUTICAL CO LTD SUN PHARMACEUTICAL INDUSTRIES LTD A II II 1/19/2007 1/12/2007 DR REDDYS LABORATORIES LTD SUN PHARMACEUTICAL INDUSTRIES LTD A A A N N A II III 3/27/2007 2/6/2007 II II II 4/24/2008 4/15/2008 7/16/2007 CIPLA LTD CIPLA LTD CIPLA LTD NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER CIPLA LTD PRIORTY PLASTICS INC ADEFOVIR DIPIVOXIL (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ARTEMETHER (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ARTESUNATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ARIPIPRAZOLE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. N N N II 6/26/2008 NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER CIPLA LTD AZELASTINE HYDROCHLORIDE BP/PH.EUR ( ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA N A N II 4/24/2007 II 5/6/2009 NOT AN ASSIGNED NUMBER CIPLA LTD NOT AN ASSIGNED NUMBER CIPLA LTD DUTASTERIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA STATUS Type SUBMIT DATE II 4/24/2007 HOLDER CIPLA LTD SUBJECT

4Q2012

FORMOTEROL FUMARATE DIHYDRATE PH. EUR. (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA

CYPROTERONE ACETATE BP/PH.EUR. (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA

MANUFACTURER OF PLASTIC BLOW MOLDED CONTAINERS AND OTHER PRODUCTS AS MANUFACTURED AT PORTLAND IN ZOLMITRIPTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN MAHARASHTRA INDIA EFAVIRENZ USP (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA STERILIZATION VALIDATION PACKAGE (ESUB) AS MANUFACTURED IN CLAYTON NC IRBESARTAN USP IN MAHARASHTRA INDIA FORMOTEROL FUMARATE DIHYDRATE AS MANUFACTURED IN VARESE ITALY PACKAGING MATERIAL (FPO) AS MANUFACTURED IN MEDINA OH PACKAGING MATERIAL (PB009146/147) AS MANUFACTURED IN MEDINA OH ALUMINIUM COLLAPSIBLE TUBES AS MANUFACTURED IN THANE INDIA ACYCLOVIR USP (API) AS MANUFACTURED IN ZHEJIANG CHINA TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN MARSA MALTA DIVALPROEX SODIUM AS MANUFACTURED IN MAHARASHTRA INDIA ATORVASTATIN MAGNESIUM AS MANUFACTURED IN BANGALORE INDIA ATOMOXETINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA SULPIRIDE EP AS MANUFACTURED IN JIANGSU CHINA BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT INDIA

Page 605

4Q2012EXCEL DMF# 20211 A 20212 20213 20214 20215 A 20216 A 20217 20218 20219 20220 20221 A 20222 20223 A 20224 20225 A 20226 20227 20228 20229 A 20230 I 20231 20232 20233 A 20234 20235 I 20236 I 20237 A 20238 A III 1/22/2007 BOREALIS AG III 1/22/2007 BOREALIS AG III 1/22/2007 BOREALIS AS A II III 1/29/2007 1/22/2007 BACHEM SA BOREALIS AS A A II II IV 1/27/2007 1/31/2007 1/31/2007 IV 1/26/2007 HENRY H OTTENS MANUFACTURING COMPANY INC IND SWIFT LABORATORIES LTD FARMABIOS S P A DOW CORNING CORP A A A II II III III 1/31/2007 1/29/2007 1/9/2007 1/19/2007 A III II 1/24/2007 1/29/2007 FUJIMORI KOGYO CO LTD ZHEJIANG JINGXIN PHARMACEUTICAL CO LTD RELIABLE BIOPHARMACEUTICAL CORP ERREGIERRE SPA DAIWA SPECIAL GLASS CO LTD AMPACET CORP TRF-7 AS MANUFACTURED IN NABARI JAPAN LEVOFLOXACIN HEMIHYDRATE AS MANUFACTURED IN ZHEJIANG CHINA LYMPHOSEEK LIGAND AS MANUFACTURED IN ST LOUIS MO RIVASTIGMINE TARTRATE AS MANUFACTURED IN BERGAMO ITALY GLASS BOTTLE AS MANUFACTURED IN HYOGO JAPAN A II II 1/31/2007 1/26/2007 GLENMARK GENERICS LTD POLYMED THERAPEUTICS INC A A A A IV II II II IV 1/23/2007 1/29/2007 1/30/2007 1/31/2007 1/31/2007 IV 1/15/2007 A A I II II II III 1/17/2007 1/29/2007 1/24/2007 1/11/2007 XELLIA PHARMACEUTICALS APS SIEGFRIED USA LLC MEDICHEM SA AMPACET CORP STATUS Type SUBMIT DATE II 1/16/2007 HOLDER AUROBINDO PHARMA LTD SUBJECT

4Q2012

AMPICILLIN SODIUM USP (STERILE) BULK AS MANUFACTURED IN ANDHRA PRADESH INDIA FLUTICASONE PROPIONATE USP AS MANUFACTURED IN ZHEJIANG CHINA CODEINE PHOSPHATE USP AS MANUFACTURED IN PENNSVILLE NJ MED - 201650/E AS MANUFACTURED IN GIRONA SPAIN 11171-A WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE IN

HENRY H OTTENS MANUFACTURING CO INC NATURAL AND ARTIFICIAL MIXED TUTTI FRUTTI FLAVOR #12346-B AS MANUFACTURED IN PHILADELPHIA PA MAPRIMED SA 913.004 N-C NAT & ART SPEARMENT FLAVOR AS MANUFACTURED IN GENEVA IL TEVA PHARMACEUTICALS INDUSTRIES LTD CHEMAGIS LTD NUTRITION 21 INC CORDEN PHARMA SWITZERLAND LLC OLANZAPINE AS MANUFACTURED IN BEER SHEVA ISRAEL EXEMESTANE AS MANUFACTURED IN BEER SHEVA ISRAEL CHROMAX CHROMIUM PICOLINATE AS MANUFACTURED IN FLINT MI N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3PHOSPHOETHANOLAMINE SODIUM SALT (MPEG-2000-DSPE) AS MANUFACTURED IN LIESTAL SWITZERLAND ESOMEPRAZOLE AS MANUFACTURED IN GUJARAT INDIA IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN CHONGQING CHINA

AMPACET PRODUCT 111818 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE IN NATURAL AND ARTIFICIAL CITRUS BERRY FLAVOR #14924 AS MANUFACTURED IN PHILADELPHIA PA NATEGLINIDE AS MANUFACTURED IN PUNJAB INDIA MIVACURIUM CHLORIDE AS MANUFACTURED IN ST LOUIS MO SILASTIC 7-4870 BIOMEDICAL GRADE LIQUID SILICONE RUBBER AS MANUFACTURED IN HEMLOCK MI ETOMIDATE AS MANUFACTURED IN VIONNAZ SWITZERLAND BOREALIS POLYPROPYLENE BORSOFT SC220CF AS MANUFACTURED IN STATHELLE NORWAY BOREALIS POLYPROPYLENE STERIPEEL WD170CF AS MANUFACTURED IN STATHELLE NORWAY BOREALIS POLYPROPYLENE BORSOFT SD233CF A HIGH IMPACT POLYPROYLENE RANDOM HETEROPHASIC COPOLYMER FOR CAST FILM APPLICATIONS AS MANUFACTURED IN KALLO-KIELDRECHT BELGIUM BOREALIS POLYPROPYLENE BORSOFT SA233CF A HIGH-IMPACT PROPYLENE RANDOM HETEROPHASIC COPOLYMER FOR BLOWN FILM APPLICATIONS AS MANUFACTURED IN KALLO-KIELDRECT BELGIUM

Page 606

4Q2012EXCEL DMF# 20239 I 20240 A 20241 I 20242 A 20243 20244 A 20245 I 20246 20247 20248 A 20249 20250 A 20251 20252 20253 20254 A 20255 A 20256 20257 I 20258 A 20259 A 20260 20261 20262 A 20263 20264 20265 20266 20267 A A A A A II II II II III 2/10/2007 2/9/2007 2/9/2007 1/29/2007 1/24/2007 A I II III II 2/12/2007 2/9/2007 2/7/2007 LUPIN LTD BASELL USA INC STERILE CEFEPIME HYDROCHLORIDE USP AS MANUFACTURED IN M P INDIA PRO-FAX HL232R AS MANUFACTURED IN LINDEN NJ II 1/8/2007 II 1/8/2007 A II II 1/28/2007 1/8/2007 II 1/8/2007 A I A II II II III 1/18/2007 2/6/2007 2/9/2007 2/1/2007 ZHEJIANG TOP MEDICINE CO LTD SAI ADVANTIUM PHARMA LTD NAVINTA LLC EQUISTAR CHEMICALS LP A II III 2/2/2007 2/2/2007 XIAN LIBANG PHARMACEUTICAL CO LTD ASTRA PLASTIQUE A A II II II 2/7/2007 2/7/2007 12/19/2006 HETERO LABS LTD INTERQUIM SA WANBURY LTD III 1/22/2007 BOREALIS AG A III III 1/22/2007 1/22/2007 BOREALIS AG BOREALIS AG BORMED SC820CF AS MANUFACTURED IN BURGHAUSEN GERMANY III 1/22/2007 BOREALIS AG III 1/22/2007 BOREALIS AG III 1/22/2007 BOREALIS AG STATUS Type SUBMIT DATE III 1/22/2007 HOLDER BOREALIS AG SUBJECT

4Q2012

BOREALIS POLYPROPYLENE BORSEAL TD210BF A TERPOLYMER FOR BOPP FILM APPLICATIONS AS MANUFACTURED IN BERINGEN BELGIUM BORMED HD800CF AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR BOREALIS AG BOREALIS POLYPROPYLENE HC101BF A POLYPROPYLENE HOMOPOLYMER FOR BOPP FILM APPLICATIONS AS MANUFACTURED IN BERINGEN BELGIUM BOREALIS POLYPROPYLENE STERIPEEL WD170CF A PO COMPOUND FOR STERILIZABLE PEELABLE FILM APPLICATIONS AS MANUFACTURED IN NORDERSTEDT, GERMANY

BORMED RD808CF AS MANUFACTURED IN BURGHAUSEN GERMANY FOR BOREALIS AG BOREALIS POLYPROPYLENE BD212CF A HIGH IMPACT POLYPROPYLENE RANDOM HETEROPHASIC COPOLYMER FOR CAST FILM APPLICATIONS AS MANUFACTURED IN SCHWECHAT-MANNSWORTH AUSTRIA ATOMOXETINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA IMIQUIMOD AS MANUFACTURED IN BARCELONA SPAIN PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN NAVI MUMBAI INDIA ROPIVACAINE HCI MONOHYDRATE AS MANUFACTURED IN SHANXI CHINA CLOSURE: 2555 (CAPE PHARMA) AS MANUFACTURED IN SAINT GEORGES DE RENEINS FRANCE CALCIUM POLYCARBOPHIL AS MANUFACTURED IN ZHEJIANG CHINA IBUTILIDE FUMARATE AS MANUFACTURED IN HYDERABAD INDIA DEFEROXAMINE MESYLATE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

ADFLEX C202M, Q100F, Q200F, Q401F, Q402, V109F, ADSYL 5C30F AND ADSYL 7372XCP AS MANUFACTURED IN PASADENA TX HUZHOU ZHANWANG PHARMACEUTICAL CO METHOTREXATE AS MANUFACTURED IN ZHEJIANG CHINA LTD TAI HENG INDUSTRY CO LTD IMIQUIMOD AS MANUFACTURED IN ZHEJIANG CHINA CHANGZHOU JIAERKE PHARMACEUTICALS PROGESTERONE AS MANUFACTURED IN JIANGSU CHINA GROUP CORP LTD ZHEJIANG GUOBANG PHARMACEUTICAL CO AZITHROMYCIN MONOHYDRATE AS MANUFACTURED IN ZHEJIANG CHINA LTD HEBEI HUARONG PHARMACEUTICAL CO LTD MECOBALAMIN AS MANUFACTURED IN HEBEI CHINA

ST GOBAIN PERFORMANCE PLASTICS CORP SANITECH STHT-C HIGH PURITY SILICONE TUBING AS MANUFACTURED IN BEAVERTON MI SUN PHARMACEUTICAL INDUSTRIES LTD BICALUTAMIDE AS MANUFACTURED IN MAHARASHTRA INDIA PAION UK LTD LUPIN LTD FIS FABBRICA ITALIANA SINTETICI SPA HEINKE TECHNOLOGY INC MORPHINE-6-B-D-GLUCURONIDE AS MANUFACTURED IN LINZ AUSTRIA STERILE CEFEPIME HYDROCHLORIDE (BUFFERED) AS MANUFACTURED IN M P INDIA TERBINAFINE HCL AS MANUFACTURED IN VICENZA ITALY PACKAGING PRE-FILED VAGINAL APPLICATOR AS MANUFACTURED IN LINCOLN NE 607 Page

4Q2012EXCEL DMF# 20268 20269 20270 20271 A 20272 A 20273 A 20274 A 20275 20276 I 20277 I 20278 A 20279 A 20280 20281 A 20282 20283 A 20284 20285 20286 A 20287 20288 20289 20290 20291 20292 A 20293 A 20294 I 20295 20296 20297 A A C III II II 2/8/2007 2/26/2007 2/23/2007 POLYONE CORP DR REDDYS LABORATORIES LTD INDUSTRIALE CHIMICA SRL IV 2/20/2007 FONA INTERNATIONAL INC II 2/20/2007 A A A A I II II II II II II 2/20/2007 11/14/2006 2/22/2007 2/20/2007 2/21/2007 2/22/2007 I C II II II 2/15/2007 2/7/2007 3/13/2007 USV LIMITED ALEMBIC PHARMACEUTICALS LTD ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTD SANOFI AVENTIS DEUTSCHLAND GMBH KYONGBO PHARMACEUTICAL CO LTD TORRENT PHARMACEUTICALS LTD PCAS GEDEON RICHTER PLC A II II 2/15/2007 2/7/2007 FORMOSA LABORATORIES INC A III III 2/14/2007 2/5/2007 TEKNOR COLOR CO AMPACET CORP IV 2/5/2007 II 2/9/2007 II 2/9/2007 A II II 2/6/2007 2/9/2007 II 2/10/2007 II 1/10/2007 LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LTD ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD SEVEN STAR PHARMACEUTICAL CO LTD EOS ECZACIBASI OZGUN KIMYASAL URUNLER SANAYI VE TICARET AS EOS ECZACIBASI OZGUN KIMYASAL URUNLER SANAYI VE TICARET A.S. EOS ECZACIBASI OZGUN KIMYASAL URUNLER SANAYI VE TICARET A.S. DAI ICHI KOGYO SEIYAKU CO LTD II 2/9/2007 SAFC BIOSCIENCES INC STATUS Type SUBMIT DATE A A A II II II II 2/13/2007 2/15/2007 2/13/2007 2/13/2007 HOLDER WANBURY LTD SYMED LABS LTD HETERO DRUGS LTD HETERO DRUGS LTD SUBJECT ATENOLOL AS MANUFACTURED IN MAHARASHTRA INDIA LINEZOLID (FORM III) AS MANUFACTURED IN HYDERABAD INDIA RITONAVIR (FORM I) AS MANUFACTURED IN ANDHRA PRADESH INDIA

4Q2012

PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA EX CELL VPRO (MODIFIED) SERUM FREE W/O L-GLUTAMINE W/O COD LIVER OIL AS MANUFACTURED IN ANDOVER HAMPSHIRE UK MEVASTATIN (NON-STERILE, BULK FORM) AS MANUFACTURED IN GUANGDONG CHINA TRANS-(-)-PAROXOL AS MANUFACTURED IN ZHEJIANG CHINA METHOCARBAMOL DC 90% AS MANUFACTURED IN TAIPEI HSIENG TAIWAN SODIUM ALENDRONATE TRIHYDRATE AS MANUFACTURED IN TEKIRDAG TURKEY AMLODIPINE BESYLATE AS MANUFACTURED IN TEKIRDAG TURKEY VALACYCLOVIR HCI MONOHYDRATE AS MANUFACTURED IN TEKIRDAG TURKEY CELLOGEN SODIUM CARBOXYMETHYL CELLULOSE (CMC) AS MANUFACTURED IN NIGATA JAPAN 91,194HCPP WHTA100:1 PACKAGING MATERIALS AS MANUFACTURED IN LODI, OH AMPACET 181907 AMBER POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE IN ANASTROZOLE AS MANUFACTURED IN TAOYUAN TAIWAN

ST GOBAIN PERFORMANCE PLASTICS CORP SANITECH 65 AS MANUFACTURED IN BEAVERTON MI DORZOLAMIDE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA TELMISARTAN AS MANUFACTURED IN GUJARAT INDIA SPIRONOLACTONE AS MANUFACTURED IN ZHEJIANG CHINA ARTICAINE HYDROCHOLORIDE AS MANUFACTURED IN GUJARAT INDIA CEFACLOR NON-STERILE API AS MANUFACTURED IN CHUNGCHEONG NAM-DO KOREA LAMOTRIGINE AS MANUFACTURED IN GUJARAT INDIA TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN LIMAY FRANCE TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN BUDAPEST HUNGARY

ORCHID CHEMICALS AND CEFDITOREN PIVOXIL AS MANUFACTURED IN KANCHEEPURAM INDIA PHARMACEUTICALS LTD ST GOBAIN PERFORMANCE PLASTICS CORP SANI-TECH LIM45 AS MANUFACTURED IN BEAVERTON MI 815.124 BUBBLEGUM FLAVOR NATURAL & ARTIFICIAL O.S. AS MANUFACTURED IN GENEVA IL CC00003753WE AS MANUFACTURED IN VONORE TN DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN A.P. INDIA ETHINYLESTRADIOL USP AS MANUFACTURED IN SARONNO ITALY

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4Q2012EXCEL DMF# 20298 20299 20300 A 20301 I 20302 20303 20304 20305 A 20306 20307 A 20308 20309 20310 A 20311 A 20312 A 20313 20314 20315 A 20316 A 20317 20318 20319 20320 20321 20322 A 20323 A 20324 A 20325 A 20326 20327 A A II II 2/28/2007 2/28/2007 SUN PHARMACEUTICAL INDUSTRIES LTD MERCK AND CIE II 3/6/2007 DR REDDYS LABORATORIES LTD V 2/28/2007 II 3/3/2007 SHANDONG WEIFANG PHARMACEUTICAL FACTORY CO LTD NANOINK INC I I A A A II III II III III III 3/2/2007 2/20/2007 3/2/2007 2/22/2007 2/22/2007 2/22/2007 MAPRIMED SA CONSOLIDATED BOTTLE DR REDDYS LABORATORIES LTD POLIMERI EUROPA FRANCE POLIMERI EUROPA FRANCE POLYONE CORP II 2/19/2007 A A III II II 2/20/2007 2/12/2007 10/17/2006 II 2/23/2007 II 2/23/2007 A A II II II 2/26/2007 2/21/2007 2/27/2007 WANBURY LTD COSMA SPA TEVA PHARMACEUTICAL INDUSTRIES LTD A II II 2/14/2007 2/24/2007 ALEMBIC PHARMACEUTICALS LTD AUROBINDO PHARMA LTD A A A II II III II 2/23/2007 2/23/2007 2/19/2007 2/26/2007 ALDRICH CHEMICAL CO ISOTEC FACILITY ALDRICH CHEMICAL CO ISOTEC FACILITY JAMESTOWN COATING TECHNOLOGIES SERATEC SODIUM OCTANOATE-1-13C AS MANUFACTURED IN MIAMISBURG OH METHACETIN-METHOXY-13C AS MANUFACTURED IN MIAMISBURG OH II 2/27/2007 STATUS Type SUBMIT DATE A A II II II 2/20/2007 2/23/2007 2/22/2007 HOLDER SUN PHARMACEUTICAL INDUSTRIES LTD EMCURE PHARMACEUTICALS LTD AUROBINDO PHARMA LTD SUBJECT IMIPRAMINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT INDIA ACETAZOLAMIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA

4Q2012

AMPICILLIN AND SULBACTAM FOR INJECTION USP (STERILE BULK MIXTURE 2:1) AS MANUFACTURED IN ANDHRA PRADESH INDIA PHARMACEUTICAL WORKS POLPHARMA SA KETOENAMINE AS MANUFACTURED IN STAROGARD GDANSKI POLAND

PACKAGING MATERIALS AND COMPONENTS AS MANUFACTURED IN JAMESTOWN PA FOMEPIZOLE (4-METHYLPYRAZOLE) AS MANUFACTURED IN COURVILLE SUR EURE FRANCE VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA ALFUZOSIN HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA CARVEDILOL AS MANUFACTURED IN MAHARASHTRA INDIA CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN CISERANO (BERGAMO), ITALY

METHYLPREDNISOLONE HEMISUCCINATE AS MANUFACTURED IN SANTHIA (VERCELLI), ITALY UNION QUIMICO FARMACEUTICA SA UQUIFA QUETIAPINE HEMIFUMARATE AS MANUFACTURED IN BARCELONA SPAIN SA SAFC BIOSCIENCES INC EX-CELL CD CHO, SERUM-FREE, CHEMICALLY DEFINED, W/O L-GLUTAMINE, W/O HYPOXANTHINE, W/O THYMIDINE AS MANUFACTURED IN DENVER PA ASTRA PLASTIQUE CLOSURE: REFERENCE 1944 AS MANUFACTURED IN ST GEORGES DE RENEINS FRANCE URQUIMA SA ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD AUROBINDO PHARMA LTD AZELASTINE HCI AS MANUFACTURED IN BARCELONA SPAIN QUINAPRIL HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA CEFOXITIN ACID (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN ANDHRA PRADESH INDIA ENALAPRIL MALEATE AS MANUFACTURED IN BUENOS AIRES ARGENTINA 500ML AMBER PET METRIC ROUND 28/400 AS MANUFACTURED IN ONTARIO CANADA VALSARTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA RIBLENE FM34 AS MANUFACTURED IN GELA ITALY RIBLENE FH10 AS MANUFACTURED IN OBERHAUSEN GERMANY CC00015845DR/WE 5026002KMBC PEROXIDE BROWN AS MANUFACTURED IN ELG GROVE VILLAGE IL GEMFIBROZIL AS MANUFACTURED IN SHANDONG CHINA PHARMACEUTICAL BRAND PROTECTION AND ANTI-COUNTERFEITING INSTRUMENTATION AND PROCESS AS MANUFACTURED IN SKOKIE IL IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA ENTACAPONE AS MANUFACTURED IN GUJARAT INDIA CALCIUM LEVOFOLINATE PENTAHYDRATE (L-LEUCOVORIN CALCIUM) AS MANUFACTURED IN SCHAFFHAUSEN SWITZERLAND

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4Q2012EXCEL DMF# 20328 20329 A 20330 20331 I 20332 20333 20334 A 20335 20336 A 20337 A 20338 20339 20340 20341 20342 20343 I 20344 20345 I 20346 20347 20348 20349 A 20350 I 20351 20352 20353 A 20354 20355 A 20356 C 20357 20358 20359 I A A II II III 3/7/2007 3/20/2007 2/19/2007 BAYER SCHERING PHARMA AG DR REDDYS LABORATORIES LTD ASTRA PLASTIQUE FLUDARA FILM-COATED TABLETS AS MANUFACTURED IN BERLIN, GERMANY II 3/7/2007 A II II 3/16/2007 3/1/2007 LEK PHARMACEUTICALS DD OLANZAPINE AS MANUFACTURED IN MENGES SLOVENIA JOHNSON MATTHEY PHARMACEUTICAL JOHNSON MATTHEY B1205 AS MANUFACTURED IN WEST DEPTFORD NJ MATERIALS ZHEJIANG HISUN PHARMACEUTICAL CO LTD LETROZOLE USP, NON-STERILE API AS MANUFACTURED IN ZHEJIANG CHINA A N II 4/5/2007 III 3/16/2007 II 3/13/2007 A A A III III IV II 3/7/2007 3/7/2007 3/8/2007 3/16/2007 RICON COLORS RICON COLORS ABELEI INC DISHMAN PHARMACEUTICALS AND CHEMICALS LTD SHANDONG NEW TIME PHARMACEUTICAL CO LTD PROMENS MEDICAL PACKAGING AS NOT AN ASSIGNED NUMBER USV LIMITED IMIQUIMOD (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA A II II 3/6/2007 3/14/2007 HIKMA PHARMACEUTICALS ZANDU CHEMICALS LTD A A A A I II III III III II III 3/9/2007 2/28/2007 2/28/2007 2/28/2007 3/1/2007 3/5/2007 II 2/28/2007 ZHEJIANG JINGXIN PHARMACEUTICAL CO LTD EXCELLA GMBH RELIANCE GROUP OF COMPANIES (IPCL) RELIANCE GROUP OF COMPANIES (IPCL) RELIANCE GROUP OF COMPANIES (IPCL) ERREGIERRE SPA BASELL POLYOLEFINE ITALIA SRL A III II 2/23/2007 3/2/2007 A A II II II 3/9/2007 3/8/2007 2/23/2007 A II II 3/7/2007 3/8/2007 CHEMAGIS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD NIPPON ZOKI PHARMACEUTICAL CO LTD SHASUN PHARMACEUTICALS LTD RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA ASTRA PLASTIQUE SEIKAGAKU CORP STATUS Type SUBMIT DATE A II IV 2/28/2007 3/6/2007 HOLDER SAFC PHARMA COLORCON SUBJECT SODIUM METAARSENITE AS MANUFACTURED IN GILLINGHAM DORSET UK STARCAP 1500 CO-PROCESSED STARCH EXCIPIENT AS MANUFACTURED IN INDIANAPOLIS IN PRAMIPEXOLE BASE AS MANUFACTURED IN BEER SHEVA ISRAEL

4Q2012

CEFUROXIME SODIUM (STERILE) AS MANUFACTURED IN KANCHEEPURAM INDIA NEUTROTROPIN TABLET AS MANUFACTURED IN HYOGO JAPAN QUINAPRIL HYDROCHLORIDE AS MANUFACTURED IN CUDDALORE INDIA DIPHENHYDRAMINE CITRATE AS MANUFACTURED IN LATINA ITALY CLOSURE: REFERENCE 3845 AS MANUFACTURED IN ST GEORGES DE RENEINS FRANCE SODIUM CHONDROITIN SULFATE SEIKAGAKU FOR INJECTION AS MANUFACTURED IN KANAGAWA JAPAN CIPROFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA ANASTROZOLE (ESUB) AS MANUFACTURED IN FEUCHT GERMANY POLYPROPYLENE (PP)SR20NC AS MANUFACTURED IN RAIGAD INDIA POLYPROPYLENE (PP) SRM100NC AS MANUFACTURED IN NAGOTHANE RAIGAD INDIA POLYPROPYLENE (PP) SR20NS AS MANUFACTURED IN NAGOTHANE RAIGAD INDIA PANTOPRAZOLE SODIUM AS MANUFACTURED IN BERGAMO ITALY PURELL ACP 6031 D AS MANUFACTURED IN WESSELING FEDERAL REPUBLIC OF GERMANY OXANDROLONE USP AS MANUFACTURED IN AMMAN JORDAN 2-HYDROXYETHYL-N,N,N',N'-TETRAKIS(2-CHLOROETHYL) PHOSPHORODIAMIDATE (TPE ALCOHOL) AS MANUFACTURED IN GUJARAT INDIA FDA ORANGE 1505C, CPP-O1261-1 AS MANUFACTURED IN WEST CHICAGO IL RED FDA CPP-R2767-2 AS MANUFACTURED IN WEST CHICAGO IL 177A32 N&A ORANGE FLAVOR AS MANUFACTURED IN N AURORA IL CETYLPYRIDINIUM CHLORIDE AS MANUFACTURED IN GUJARAT INDIA ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN SHANDONG CHINA RD BOTTLES AS MANUFACTURED IN LANGESKOV DENMARK

LOSARTAN POTASSIUM FORM-1 AS MANUFACTURED IN ANDHRA PRADESH INDIA CLOSURE: VISTOP 28 AS MANUFACTURED IN SAINT-GEORGES DE RENEINS FRANCE

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4Q2012EXCEL DMF# 20360 A 20361 20362 20363 20364 20365 20366 20367 20368 A 20369 20370 20371 20372 A 20373 20374 20375 20376 20377 20378 20379 20380 20381 20382 20383 A 20384 A 20385 20386 20387 20388 20389 20390 A 20391 A 20392 20393 A 20394 I IV 3/25/2007 UMANG PHARMATECH PVT LTD A II II 4/2/2007 3/29/2007 II 3/31/2007 A A I A A II II IV II IV II 3/28/2007 3/28/2007 3/8/2007 3/30/2007 3/30/2007 3/26/2007 EUTICALS INC TORRENT PHARMACEUTICALS LTD ACCEL COLOR CORP CADILA HEALTHCARE LTD SPI PHARMA INC HANGZHOU HUADONG MEDICINE GROUP BIOTECHNOLOGY INSTITUTE CO LTD CHONGQING SHENGHUAXI PHARMACEUTICAL CO LTD GLENMARK GENERICS LTD AUROBINDO PHARMA LTD II 3/26/2007 A A A A A A A A A I II II II II III II II II II IV II 3/26/2007 3/21/2007 3/26/2007 3/26/2007 3/26/2007 3/19/2007 3/28/2007 3/29/2007 3/28/2007 3/13/2007 3/28/2007 CADILA HEALTHCARE LTD TAI HENG INDUSTRY CO LTD STERLING SRL PHARMAZELL GMBH EI DUPONT DE NEMOURS & CO INC ALEMBIC PHARMACEUTICALS LTD CADILA HEALTHCARE LTD RANBAXY LABORATORIES LTD GLENMARK GENERICS LTD EEI CAPSULES LTD A I A III III III II 3/23/2007 3/22/2007 3/2/2007 3/16/2007 MULTISORB TECHNOLOGIES INC EP SPRAY SYSTEMS DRAGON PLASTICS LTD ORGAPHARM SAS A A A A A N A II II 3/20/2007 3/19/2007 II II II II II 3/22/2007 3/23/2007 5/30/2007 3/22/2007 3/22/2007 CADILA HEALTHCARE LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD CADILA HEALTHCARE LTD DIPHARMA FRANCIS SRL NOT AN ASSIGNED NUMBER VASUDHA PHARMA CHEM LTD OLON SPA LORATADINE USP AS MANUFACTURED IN HYDERABAD INDIA STATUS Type SUBMIT DATE III 3/12/2007 HOLDER FLEXTRUS AB SUBJECT

4Q2012

TRANSOFOIL EL-OPET/PELD LAMINATE, SPECIFICATIONS 2282150-0012 AND 2282150-0020 AS MANUFACTURED IN LUND SWEDEN IRBESARTAN AS MANUFACTURED IN GUJARAT INDIA MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA LOPINAVIR (LOP) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ATOMOXETINE HCL AS MANUFACTURED IN GUJARAT INDIA PROTRIPTYLINE HYDROCHLORIDE AS MANUFACTURED IN VARESE ITALY

DEACETYL 7 AMINO CEPHALOSPORANIC ACID (HACA) AS MANUFACTURED IN SETTIMO TORINESE ITALY MOISTURE REGULATING PRODUCTS AS MANUFACTURED IN BUFFALO NY BAG-ON-VALVE AS MANUFACTURED IN MCHENRY IL CLOSURES AS MANUFACTURED IN PONTYPRIDD, UK PROTOPORPHYRIN IX DIMETHYL ESTER (PPIX-DME) AS MANUFACTURED IN PITHIVIERS FRANCE SIMVASTATIN (AMMONIUM SALT ROUTE) AS MANUFACTURED IN GUJARAT INDIA MEFENAMIC ACID AS MANUFACTURED IN SHANGHAI CHINA FLUNISOLIDE ANHYDROUS AS MANUFACTURED IN PERUGIA ITALY CARBAMAZEPINE AS MANUFACTURED IN RAUBLING, GERMANY DUPONT TYVEK RX-CR AS MANUFACTURED IN HAVERHILL MA IRBESARTAN AS MANUFACTURED IN GUJARAT INDIA ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA RAMIPRIL AS MANUFACTURED IN PUNJAB INDIA APREPITANT AS MANUFACTURED IN GUJARAT INDIA EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN MADHYA PRADESH INDIA

CALYX CHEMICALS AND PHARMACEUTICALS ERYTHROMYCIN ESTOLATE AS MANUFACTURED IN MAHARASTHTRA INDIA LTD PHARMACEUTICAL WORKS POLPHARMA SA SODIUM RISEDRONATE AS MANUFACTURED IN STAROGARD GDANSKI POLAND DEXMETHYLPHENIDATE HYDROCHLORIDE AS MANUFACTURED IN SPRINGFIELD MO TOPIRAMATE AS MANUFACTURED IN GUJARAT INDIA 1101P3CP1 RED 1608 AS MANUFACTURED IN NAPERVILLE IL MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA SODIUM BICARBONATE PRODUCTS AS MANUFACTURED IN GRAND HAVEN MI TACROLIMUS AS MANUFACTURED IN ZHEJIANG CHINA SODIUM IBANDRONATE AS MANUFACTURED IN CHONGQING CHINA ESOMEPRAZOLE POTASSIUM AS MANUFACTURED IN GUJARAT INDIA IBANDRONATE SODIUM (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA SPRAYSPHERE AS MANUFACTURED IN MAHARASHTRA INDIA

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4Q2012EXCEL DMF# 20395 20396 20397 A 20398 A 20399 20400 20401 20402 A 20403 A 20404 20405 20406 20407 20408 20409 20410 20411 A 20412 20413 20414 A 20415 A 20416 A 20417 20418 A 20419 20420 20421 20422 A 20423 20424 20425 20426 20427 A A A A A II II II II II 3/17/2007 3/22/2007 3/26/2007 4/9/2007 4/5/2007 A A A II II II II 3/27/2007 3/28/2007 4/9/2007 4/9/2007 MYLAN LABORATORIES LTD ALEMBIC PHARMACEUTICALS LTD BASF CORP ORCHID CHEMICALS AND PHARMACEUTICALS LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD GLENMARK GENERICS LTD CHEMI SPA ATAZANAVIR SULFATE AS MANUFACTURED IN ANDHRA PRADESH INDIA MEPROBAMATE AS MANUFACTURED IN GUJARAT INDIA IBUPROFEN DC 85 AS MANUFACTURED IN SHREVEPORT LA IBANDRONATE SODIUM AS MANUFACTURED IN MAHARASHTRA INDIA STAVUDINE USP (STR) AS MANUFACTURED IN ANDHRA PRADESH INDIA A II II 3/23/2007 3/15/2007 II 4/6/2007 II 4/6/2007 ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD A A II II II 4/4/2007 4/5/2007 5/14/2007 SIGNA SA DE CV MSN LABORATORIES LTD BAYER PHARMA AG LEVETIRACETAM AS MANUFACTURED IN TOLUCA MEXICO A A A A I A A II II III II IV II II II 3/30/2007 3/29/2007 4/4/2007 3/23/2007 4/3/2007 3/31/2007 4/5/2007 4/5/2007 LUPIN LTD ERCROS SA 3M DRUG DELIVERY SYSTEMS TAKASAGO INTERNATIONAL CORP SYMRISE INC WANBURY LTD NATCO PHARMA LTD NATCO PHARMA LTD III 4/2/2007 COLORS FOR PLASTICS INC A A A II II II II 4/2/2007 4/2/2007 4/2/2007 4/2/2007 MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD II 4/2/2007 STATUS Type SUBMIT DATE I I IV IV II 3/25/2007 3/25/2007 4/3/2007 HOLDER UMANG PHARMATECH PVT LTD UMANG PHARMATECH PVT LTD JIANGSU YUNYANG GROUP PHARMACEUTICAL CO LTD MYLAN LABORATORIES LTD SUBJECT SPRAYMIX AS MANUFACTURED IN MAHARASHTRA INDIA SPRAYPOL AS MANUFACTURED AT MAHARASHTRA INDIA CLOTRIMAZOLE AS MANUFACTURED IN JIANGSU CHINA

4Q2012

RISEDRONATE SODIUM USP (HEMI-PENTAHYDRATE) AS MANUFACTURED IN ANDHRA PRADESH INDIA ATENOLOL USP AS MANUFACTURED IN ANDHRA PRADESH INDIA CANDESARTAN CILEXETIL AS MANUFACTURED IN ANDHRA PRADESH INDIA CARVEDILOL PHOSPHATE AS MANUFACTURED IN ANDHRA PRADESH INDIA ALENDRONATE SODIUM USP (TRIHYDRATE) AS MANUFACTURED IN ANDHRA PRADESH INDIA THERMOPLASTIC RESIN COLORANT MASTERBATCH G23379 AS MANUFACTURED IN ELK GROVE VILLAGE, IL ETHAMBUTOL HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA SODIUM FUSIDATE AS MANUFACTURED IN MADRID SPAIN 3M INTEGRATED DOSE-BY-DOSE COUNTER RU-COMPLEX SOLUTION AS MANUFACTURED IN IWATA JAPAN VANILLA FL PWD N ET A GIN #605003 AS MANUFACTURED IN MAHWAH NJ RISPERIDONE AS MANUFACTURED IN MAHARASHTRA INDIA IMATINIB METHANE SULFONATE AS MANUFACTURED IN ANDHRA PRADESH INDIA IBANDRONATE SODIUM MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA

TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA EOB-DTPA (ESUB) AS MANUFACTURED IN BERGKAMEN GERMANY

ALENDRONATE SODIUM TRIHYDRATE AS MANUFACTURED IN MAHARASHTRA INDIA DIPYRIDAMOLE AS MANUFACTURED IN MAHARASHTRA INDIA OLMESARTAN MEDOXOMIL AS MANUFACTURED IN ANDHRA PRADESH INDIA PROPAFENONE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

ALMOTRIPTAN MALATE ( ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA MONTELUKAST SODIUM AS MANUFACTURED IN ANDHRA PRADESH INDIA MOEXIPRIL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA SODIUM IBANDRONATE MONOHYDRATE AS MANUFACTURED IN PATRICA ITALY Page

612

4Q2012EXCEL DMF# 20428 A 20429 20430 20431 20432 A 20433 A 20434 A 20435 A 20436 20437 20438 20439 20440 A 20441 20442 20443 20444 A 20445 20446 A II II 4/5/2007 5/3/2007 C A I II II II II 4/19/2007 4/3/2007 4/17/2007 4/14/2007 TEVA PHARMACEUTICAL INDUSTRIES LTD BEIJING YI HE BIOTECH CO LTD TEVA PHARMACEUTICAL INDUSTRIES LTD VITALIFE LABORATORIES DIV ARCH PHARMALABS LTD FIDIA FARMACEUTICI SPA JANSSEN PHARMACEUTICA NV A A A A II II II II II 3/31/2007 4/11/2007 4/12/2007 4/6/2007 4/18/2007 II 4/13/2007 II 3/25/2007 II 3/25/2007 I A A IV III II II 4/11/2007 4/10/2007 4/7/2007 4/9/2007 PHARMACEUTICAL COATINGS PVT LTD HOSPIRA INC QILU PHARMACEUTICAL CO LTD QILU PHARMACEUTICAL CO LTD STATUS Type SUBMIT DATE II 4/5/2007 HOLDER QILU TIANHE PHARMACEUTICAL CO LTD SUBJECT

4Q2012

TAZOBACTAM ACID (PROCESS I, NON-STERILE BULK) AS MANUFACTURED IN SHANDONG CHINA AEROLAC AS MANUFACTURED IN NAVI MUMBAI INDIA ANSYR SYRINGE DRUG PRODUCT AS MANUFACTURED IN ROCKY MOUNT NC PIPERACILLIN (NON STERILE BULK FORM) AS MANUFACTURED IN SHANDONG CHINA

STERILE PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM (8:1) AS MANUFACTURED IN SHANDONG CHINA KUNSHAN ORIENTAL PHARMACEUTICAL CO PHENYTOIN SODIUM AS MANUFACTURED IN JIANGSU CHINA LTD KUNSHAN ORIENTAL PHARMACEUTICAL CO PHENYTOIN AS MANUFACTURED IN JIANGSU CHINA LTD BIO VECTRA INC 20 KDA MPEG-O-2-METHYLPROPIONALDEHYDE AS MANUFACTURED IN PRINCE EDWARD ISLAND CANADA LUPIN LTD RIFAXIMIN (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA PIRAMAL HEALTHCARE LTD APICORE LLC WOCKHARDT LTD JANSSEN PHARMACEUTICA NV GEMFIBROZIL AS MANUFACTURED IN ANDHRA PRADESH INDIA FELBAMATE (ESUB) AS MANUFACTURED IN SOMERSET NJ ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA ETRAVIRINE (R165335) DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN BEERSE BELGIUM DORZOLAMIDE HCL AS MANUFACTURED IN BE'ER SHEVA ISRAEL 10 DEACETYL BACCATIN III AS MANUFACTURED IN BEIJING CHINA SODIUM ALENDRONATE AS MANUFACTURED IN ZAGREB CROATIA CLOPIDOGREL BISULFATE USP (FORM-I) (ESUB) AS MANUFACTURED IN HARYANA INDIA ACYCLOVIR AS MANUFACTURED IN MULAZZANO (LO) ITALY CEFTOBIPROLE MEDOCARIL (R473928) DRUG SUBSTANCE (ESUB) AS MANUFACTURED BY ANTIBIOTICOS SPA IN RODANO, ITALY; PATHEON UK LTD IN U.K.; BUTTERWORTH LABORATORIES LTD IN U.K. & JANSSEN PHARMACEUTICA N.V. IN BELGIUM FOR JANSSEN PHARMACEUTICA N.V. LORATADINE (LCP) USP AS MANUFACTURED IN ANDHRA PRADESH INDIA ALPRAZOLAM AS MANUFACTURED IN TAMIL NADU INDIA CARPROFEN AS MANUFACTURED IN ZHEJIANG CHINA CLINDAMYCIN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA P-METHOXYBENZYL(6R,7R)-3-CHLOROMETHYL-8-OXO-7-PHENYLACETAMIDO-5-THIA-1AZABICYCLO [4.2.0]OCT-2-ENE-2-CARBOXYLATE, GCLE AS MANUFACTURED IN TOKUSHIMA JAPAN MYCOPHENOLIC ACID AS MANUFACTURED IN CHONGQING CHINA PHENYTOIN SODIUM AS MANUFACTURED IN MAHARASHTRA INDIA VALACYCLOVIR HYDROCHLORIDE (ESUB) THEOPHYLLINE HYDROUS AS MANUFACTURED IN MINDEN, GERMANY

A 20447 20448 A 20449 I 20450 A 20451 A 20452 A 20453 A 20454 20455 A A II II 4/16/2007 4/19/2007 II 4/17/2007 II 4/17/2007 CHONGQING DAXIN PHARMACEUTICAL CO LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD LUPIN LTD BASF PHARMACHEMIKALIEN GMBH CO KG II 4/10/2007 II 3/28/2007 II 4/12/2007 A II II 4/20/2007 4/10/2007 MYLAN LABORATORIES LTD MALLADI DRUGS AND PHARMACEUTICALS LTD ZHEJIANG HISOAR PHARMACEUTICAL CO LTD CHUANNAN BRANCH ZHEJIANG TIANTAI PHARMACEUTICAL CO LTD OTSUKA CHEMICAL CO LTD

Page 613

4Q2012EXCEL DMF# 20456 20457 A 20458 20459 20460 20461 20462 A 20463 A 20464 20465 20466 A 20467 20468 20469 20470 20471 20472 A 20473 I 20474 A 20475 A 20476 A 20477 A 20478 A 20479 20480 I 20481 A 20482 A 20483 A II 4/24/2007 II 12/30/2006 II 12/28/2006 A II II 4/27/2007 3/19/2007 ERCROS SA QILU ANTIBIOTICS PHARMACEUTICAL CO LTD QILU ANTIBIOTICS PHARMACEUTICAL CO LTD QILU ANTIBIOTICS PHARMACEUTICAL CO LTD ERREGIERRE SPA FUSIDIC ACID AS MANUFACTURED IN ARANJUEZ MADRID SPAIN STERILE CEFOTAXIME SODIUM AS MANUFACTURED IN SHANDONG CHINA CEFTAZIDIME FOR INJECTION AS MANUFACTURED IN SHANDONG CHINA STERILE CEFTRIAXONE SODIUM AS MANUFACTURED IN SHANDONG CHINA TOLTERODINE TARTRATE AS MANUFACTURED IN BERGAMO ITALY II 4/27/2007 LONZA BRAINE SA III 4/18/2007 II 4/24/2007 II 4/23/2007 MALLADI DRUGS AND PHARMACEUTICALS LTD DISHMAN PHARMACEUTICALS AND CHEMICALS LTD ST GOBAIN PERFORMANCE PLASTICS II 4/25/2007 NOF CORP III 3/8/2007 GERRESHEIMER BOLESLAWIEC S A A I I A A III II II II II III 4/13/2007 3/30/2007 3/14/2007 4/23/2007 4/23/2007 4/2/2007 POLYONE CORP ANHUI BIOCHEM PHARM CO LTD USV LTD FLEMING LABORATORIES LTD SEVEN STAR PHARMACEUTICAL CO LTD HEINKE TECHNOLOGY INC CC00022680DR AS MANUFACTURED IN VONORE TN LAMIVUDINE AS MANUFACTURED IN ANHUI CHINA ANASTROZOLE AS MANUFACTURED IN MAHARASHTRA INDIA MECLIZINE HCL AS MANUFACTURED IN ANDHRA PRADESH INDIA CHLORZOXAZONE AS MANUFACTURED IN TAIPEI HSIENG TAIWAN A A II II II 4/12/2007 4/23/2007 4/23/2007 CADILA PHARMACEUTICALS LTD FORMOSA LABORATORIES INC DR REDDYS LABORATORIES LTD II 4/24/2007 FARMABIOS S P A A A A A III III III III II 4/13/2007 4/13/2007 4/13/2007 4/13/2007 4/18/2007 3M DRUG DELIVERY SYSTEMS 3M DRUG DELIVERY SYSTEMS 3M DRUG DELIVERY SYSTEMS 3M DRUG DELIVERY SYSTEMS MEGAFINE PHARMA P LTD STATUS Type SUBMIT DATE A II II 3/30/2007 4/13/2007 HOLDER LUPIN LTD LUPIN LTD SUBJECT MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA ESOMEPRAZOLE MAGNESIUM DIHYDRATE ( ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA 3M COTRAN 9718 AS MANUFACTURED IN BROOKINGS SD 3M SCOTCHPAK 9736 AS MANUFACTURED IN COTTAGE GROVE MN 3M MEDICAL TAPE #1772 AS MANUFACTURED IN BROOKINGS SD 3M MEDICAL TAPE #9762 AS MANUFACTURED IN BROOKINGS SD

4Q2012

1-(3-HYDROXY METHYL PYRIDYL-2-)-2-PHENYL-4-METHYL PIPERAZINE (HMPPMP) (NONSTERILE DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN GUJARAT INDIA FLUTICASONE PROPIONATE USP/PH.EUR. (MICRONIZED) AS MANUFACTURED IN PV ITALY ARIPIPRAZOLE AS MANUFACTURED IN GUJARAT INDIA MEPROBAMATE AS MANUFACTURED IN TAOYUAN TAIWAN IBANDRONATE SODIUM MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA

SIDE DISPERSION PRE-FILLED VAGINAL APPLICATOR AS MANUFACTURED IN LINCOLN NE GLASS AMPOULES, VIALS, AND SAMPLES MADE FROM GLASS TUBES FOR VARIOUS PRODUCTS OF HEALTH CARE SECTIONS UP TO CONTENTS OF 30 ML AS MANUFACTURED IN BOLESLAWIEC POLAND DISTEAROYL PHOSPHATIDYL GLYCEROL SODIUM SALT (DSPG-NA) AS MANUFACTURED IN HYOGO JAPAN PHENYLEPHRINE BITARTRATE AS MANUFACTURED IN TAMIL NADU INDIA BISACODYL AS MANUFACTURED IN GUJARAT INDIA POLYESTER FILM C/1/S WITH 8005 SILICONE RELEASE COATING AS MANUFACTURED IN WORCESTER MA THYMOSIN-A-1, DRUG SUBSTANCE AS MANUFACTURED IN BRAINE-1' ALLEUD BELGIUM

Page 614

4Q2012EXCEL DMF# 20484 A 20485 A 20486 I 20487 I 20488 A 20489 20490 20491 20492 20493 20494 20495 20496 20497 20498 20499 20500 A 20501 A 20502 20503 20504 20505 20506 20507 20508 20509 20510 20511 20512 20513 20514 20515 20516 A 20517 A II 5/9/2007 A A A I I I I A A A A A A A II IV II IV IV IV IV II II II II II II II II 5/1/2007 5/3/2007 5/1/2007 5/3/2007 5/3/2007 5/3/2007 5/3/2007 5/3/2007 5/7/2007 5/7/2007 5/2/2007 5/2/2007 5/8/2007 5/8/2007 5/3/2007 II 4/30/2007 ZHEJIANG SUPOR PHARMACEUTICALS CO LTD AARTI INDUSTRIES LTD DO COOP TECHNOLOGIES LTD PCAS FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC CADILA PHARMACEUTICALS LTD TARO PHARMACEUTICAL INDUSTRIES LTD DR REDDYS LABORATORIES LTD BAYER SCHERING PHARMA AG BAYER PHARMA AKTIENGESELLSCHAFT FIDIA FARMACEUTICI SPA FIDIA FARMACEUTICI SPA ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD ZHUHAI UNITED LABORATORIES CO LTD I I I A I A A A A A C IV IV IV II V II II II IV II II II 4/24/2007 4/24/2007 4/24/2007 4/27/2007 4/30/2007 4/30/2007 4/23/2007 4/30/2007 4/24/2007 4/26/2007 4/30/2007 4/30/2007 MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MITSUI NORIN CO LTD CATALENT PHARMA SOLUTIONS INC TEVA PHARMACEUTICAL INDUSTRIES LTD WANBURY LTD AARTI DRUGS LTD FMC BIOPOLYMER AS SUVEN LIFE SCIENCES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD CHEMWERTH INC II 4/26/2007 III 4/17/2007 II 12/28/2006 II 12/20/2006 QILU ANTIBIOTICS PHARMACEUTICAL CO LTD QILU ANTIBIOTICS PHARMACEUTICAL CO LTD CHESAPEAKE PLASTICS PACKAGING KUNSHAN CO LTD MACCO ORGANIQUES SRO STATUS Type SUBMIT DATE III 4/27/2007 HOLDER BESPAK DIV CONSORT MEDICAL PLC SUBJECT

4Q2012

BK361003MTA PHARMACEUTICAL METERING VALVE AS MANUFACTURED IN NORFOLK ENGLAND STERILE CEFOPERAZONE SODIUM AS MANUFACTURED IN SHANDONG CHINA STERILE CEFAZOLIN SODIUM AS MANUFACTURED IN SHANDONG CHINA PACKAGING MATERIAL AS MANUFACTURED IN JIANGSU CHINA MAGNESIUM CHLORIDE HEXAHYDRATE AS MANUFACTURED IN BRUNTAL CZECH REPUBLIC 06201.1 DRYCELL YOGURT FLAVOUR AS MANUFACTURED IN TORINO ITALY 06300.1 DRYCELL ORANGE FLAVOUR AS MANUFACTURED IN TORINO ITALY B03373F.1 ORANGE FLAVOUR AS MANUFACTURED IN TORINO ITALY POLYPHENON E (USAN: SINECATECHINS) AS MANUFACTURED IN HIDA-SHI GIFU JAPAN CARDINAL HEALTH NORTH RALEIGH STERILE MANUFACTURING FACILITY IBANDRONATE SODIUM AS MANUFACTURED IN GUAYAMA PUERTO RICO CLOPIDOGREL BISULFATE AS MANUFACTURED IN MAHARASHTRA INDIA LORATADINE AS MANUFACTURED IN MAHARASHTRA INDIA CALCIUM ALGINATE AS MANUFACTURED IN OSLO NORWAY FENOPROFEN CALCIUM USP AS MANUFACTURED IN ANDHRA PRADESH INDIA ATOMOXETINE HYDROCHLORIDE AS MANUFACTURED IN MILANO ITALY ETOMIDATE EP NON STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG CHINA CLARITHROMYCIN USP AS MANUFACTURED IN ZHEJIANG CHINA BICALUTAMIDE AS MANUFACTURED IN MAHARASHTRA INDIA NEOWATER AS MANUFACTURED IN OR-YEHUDA ISRAEL MIFEPRISTONE AS MANUFACTURED IN ARAMON FRANCE 884.114 N-C NAT & ART ORANGE FLAVOR AS MANUFACTURED IN GENEVA IL 862.378 NATURAL LEMON FLAVOR WONF AS MANUFACTURED IN GENEVA IL 895.032 N-C ART PINEAPPLE FLAVOR AS MANUFACTURED IN GENEVA IL 825.527 N-C CHERRY FLAVOR ARTIFICIAL AS MANUFACTORED IN GENEVA IL LOSARTAN POTASSIUM AS MANUFACTURED IN GUJARAT INDIA PREDNICARBATE USP MICRONIZED AS MANUFACTURED IN HAIFA BAY ISRAEL FOSPHENYTOIN SODIUM AS MANUFACTURED IN ANDHRA PRADESH INDIA MS-275 FILM-COATED TABLETS AS MANUFACTURED IN BERLIN, GERMANY MS-275 AS MANUFACTURED IN BERLIN, GERMANY FAMCYCLOVIR AS MANUFACTURED IN GARBAGNATE MILANESE ITALY ABACAVIR SULFATE AS MANUFACTURED IN MULAZZANO (LO) ITALY OXCARBAZEPINE AS MANUFACTURED IN ZHEJIANG CHINA AMOXICILLIN API AS MANUFACTURED IN ZHUHAI GUANGDONG CHINA

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4Q2012EXCEL DMF# 20518 A 20519 20520 20521 20522 I 20523 I 20524 A 20525 20526 20527 A 20528 20529 A 20530 20531 20532 20533 20534 20535 A 20536 A 20537 A 20538 20539 20540 20541 A 20542 A 20543 20544 20545 20546 20547 A 20548 A II 5/23/2007 A A A A II II II II III 5/9/2007 5/21/2007 5/23/2007 5/22/2007 5/17/2007 OLAINFARM JOINT STOCK CO CHEMPACIFIC CORP UNIMARK REMEDIES LTD AMRI RENSSELAER INC AMCOR FLEXIBLES ITALIA SRL II 6/26/2007 A A I II II II II 5/11/2007 5/17/2007 5/15/2007 3/27/2007 ALPS PHARMACEUTICAL IND CO LTD ARCH PHARMALABS LTD LUNDBECK PHARMACEUTICALS ITALY SPA CHANGZHOU QIANHONG BIO PHARMA CO LTD STRAGEN PHARMA SA PROTAMINE SULFATE AS MANUFACTURED IN HIDA GIFU JAPAN IV 5/14/2007 NIPPON FINE CHEMICAL CO LTD III 5/4/2007 A A I A A III III II II II II 5/9/2007 5/9/2007 5/10/2007 5/1/2007 4/18/2007 5/6/2007 3M DRUG DELIVERY SYSTEMS 3M DRUG DELIVERY SYSTEMS ASAHI KASEI PHARMA CORP KAKEN PHARMACEUTICAL CO LTD UNICHEM LABORATORIES LTD ZHEJIANG NEO DANKONG PHARMACEUTICAL CO LTD COLORTECH INC 3M COTRAN 9766 AS MANUFACTURED IN ABERDEEN SD I II II 5/11/2007 5/10/2007 USV LTD A A II IV IV 5/11/2007 5/11/2007 5/11/2007 APOTEX PHARMACHEM INC COREL PHARMACHEM COREL PHARMACHEM II 5/10/2007 POLYMED THERAPEUTICS INC III 5/8/2007 HEINKE TECHNOLOGY INC A A A III II II II 4/17/2007 5/9/2007 5/10/2007 5/8/2007 STATUS Type SUBMIT DATE II 5/8/2007 HOLDER ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD ALUCAN ENTEC SAU HETERO LABS LTD DR REDDYS LABORATORIES LTD DELMAR CHEMICALS INC SUBJECT RISPERIDONE AS MANUFACTURED IN ZHEJIANG CHINA PACKAGING MATERIAL AS MANUFACTURED IN BADALONA SPAIN

4Q2012

HYDRALAZINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA FINASTERIDE (FORM I) AS MANUFACTURED IN ANDHRA PRADESH INDIA LEVODOPA METHYL ESTER HYDROCHLORIDE AS MANUFACTURED IN QUEBEC CANADA POWDER DISPENSING PRE-FILLED VAGINAL APPLICATOR AS MANUFACTURED IN LINCOLN NE CHOLECALCIFEROL CONCENTRATE (POWDER FORM) DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG CHINA IBANDRONATE SODIUM AS MANUFACTURED IN ONTARIO CANADA KYRON POLACRILLIN POTASSIUM AS MANUFACTURED IN KADI INDIA ACRYSOL POLYOXYL 40 HYDROGENATED CASTOR OIL AS MANUFACTURED IN KADI INDIA FLUVASTATIN SODIUM USP AS MANUFACTURED IN MAHARASHTRA INDIA

ST GOBAIN PERFORMANCE PLASTICS CORP PHARMAFLOUR FEP BIOCOMPATIBLE TUBING AS MANUFACTURED IN AKRON OH

3M COTRAN 9769 POLYETHYLENE TAPE AS MANUFACTURED IN BROOKINGS SD UBIDECARENONE AS MANUFACTURED IN HOKKAIDO JAPAN KP-103 AS MANUFACTURED IN TOYAMA JAPAN HYDROCHLOROTHIAZIDE - PROCESS #2 (ESUB) AS MANUFACTURED IN RAIGAD INDIA ATORVASTATIN SODIUM NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG CHINA 11030-18 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN TN DSPC-K2 (DISTEAROYLPHOSPHATIDYLCHOLINE) AS MANUFACTURED IN HYOGO JAPAN

CETIRIZINE DIHYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN PODOVA ITALY DALTEPARIN SODIUM AS MANUFACTURED IN JIANGSU CHINA HOMOHARRINGTONINE (HHT) DRUG SUBSTANCE AS MANUFACTURED IN LE MANS, FRANCE. MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN OLAINE LATVIA CHPO16 DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE MD CEFUROXIME AXETIL USP AS MANUFACTURED IN GUJARAT INDIA ECHOTHIOPHATE IODIDE DRUG SUBSTANCE AS MANUFACTURED IN RENSSELAER NY

FLEXIBLE PACKAGING MATERIAL AS PRIMARY PACKAGING COMPONENT FOR DRUG AS MANUFACTURED IN LUGO DI VICENZA ITALY PHARMACEUTICAL WORKS POLPHARMA SA LAMOTRIGINE AS MANUFACTURED IN STAROGARD GDANSKI POLAND

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4Q2012EXCEL DMF# 20549 A 20550 20551 20552 20553 A 20554 A 20555 A 20556 20557 20558 I 20559 20560 20561 20562 20563 20564 20565 A 20566 A 20567 20568 A 20569 A 20570 A 20571 20572 20573 20574 20575 20576 A 20577 20578 20579 20580 A A A A II II II II 6/7/2007 5/31/2007 6/11/2007 6/7/2007 HETERO DRUGS LTD BOCA PHARMACAL INC CADILA HEALTHCARE LTD MSN PHARMACHEM PVT LTD A A A A A II II II II II II 6/1/2007 4/10/2007 5/29/2007 5/31/2007 5/25/2007 7/4/2006 TEVA PHARMACEUTICAL INDUSTRIES LTD WANBURY LTD WANBURY LTD SUN PHARMACEUTICAL INDUSTRIES LTD GLENMARK GENERICS LTD RENOLIT NEDERLAND BV II 5/28/2007 II 6/1/2007 A II IV 5/29/2007 5/10/2007 II 5/29/2007 A I I A A A II II II II II II II 5/18/2007 5/25/2007 6/25/2007 5/29/2007 5/30/2007 5/31/2007 5/15/2007 FIDIA FARMACEUTICI SPA RANBAXY LABORATORIES LTD ALKERMES GAINESVILLE LLC FRESENIUS KABI AUSTRIA GMBH SIEGFRIED LTD UNIMARK REMEDIES LTD ZHEJIANG CHIRAL MEDICINE CHEMICALS CO LTD ACTAVIS PHARMA MANUFACTURING PRIVATE LTD ALDRICH CHEMICAL CO ISOTEC FACILITY MOLKEREI MEGGLE WASSERBURG GMBH AND CO KG JOHNSON MATTHEY PHARMACEUTICAL MATERIALS MEGAFINE PHARMA P LTD A A II II III 5/23/2007 5/23/2007 5/17/2007 DAINIPPON SUMITOMO PHARMA CO LTD AARTI INDUSTRIES LTD SEASONS POLYMERS PVT LTD V 5/22/2007 ASEPTIC TECHNOLOGIES SA III 4/18/2007 INEOS SERVICES BELGIUM NV A A A II II II III 5/18/2007 5/18/2007 5/21/2007 4/18/2007 SIGMA ALDRICH MANUFACTURING LLC SIGMA ALDRICH MANUFACTURING LLC SUN PHARMACEUTICAL INDUSTRIES LTD INEOS SERVICES BELGIUM NV STATUS Type SUBMIT DATE II 5/18/2007 HOLDER SIGMA ALDRICH MANUFACTURING LLC SUBJECT

4Q2012

STEMLINE NEURAL STEM CELL EXPANSION MEDIUM AS MANUFACTURED IN ST LOUIS MO CHO KIT 2 IRON CHELATOR SOLUTION AS MANUFACTURED IN ST LOUIS MO CHO MEDIUM MODIFICATION 21 AS MANUFACTURED IN ST LOUIS MO ATOMOXETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA INEOS POLYPROPYLENE GRADE 101-SA09 AS MANUFACTURED IN BRUSSELS BELGIUM INEOS POLYPROPYLENE GRADE 194-NA25 AS MANUFACTURED IN BRUSSELS BELGIUM PHARMACEUTICAL FILLING FACILITY FOR FILLING STERILE INJECTABLE DEVELOPMENT SAMPLES AND CLINICAL SUPPLIES AT LES ISNES BELGIUM DROXIDOPA AS MANUFACTURED IN TSURUSAKI OITA JAPAN LEVALBUTEROL HCL AS MANUFACTURED IN MAHARASHTRA INDIA PLASTIC BOTTLES/CONTAINERS, NOZZLES, PILFER PROOF/TAMPER EVIDENT CAPS, MEASURING CUPS, CHILD RESISTANT CAPS, CLOSURES AS MANUFACTURED IN KUNDAIM INDIA ATAZANAVIR SULFATE AS MANUFACTURED IN MULAZZANO ITALY EFAVIRENZ AS MANUFACTURED IN HARYANA INDIA ELND-005 AS MANUFACTURED IN ELAN ATHLONE, IRELAND. LACTULOSE CONCENTRATE USP AS MANUFACTURED IN LINZ AUSTRIA BENZPHETAMINE HYDROCHLORIDE AS MANUFACTURED IN ZOFINGEN SWITZERLAND MONTELUKAST SODIUM AS MANUFACTURED IN GUJARAT INDIA METHYLDOPA AS MANUFACTURED IN ZHEJIANG CHINA LETROZOLE USP NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN TAMIL NADU INDIA POTASSIUM PALMITATE -1,2,3,4-(13)C4 AS MANUFACTURED IN MIAMISBURG OH STARLAC AS MANUFACTURED IN WASSERBURG, GERMANY FLUVOXAMINE MALEATE (SVB) AS MANUFACTURED IN CONSHOHOCKEN PA MIRTAZAPINE ANHYDROUS USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN NASHIK INDIA TELMISARTAN AS MANUFACTURED IN BE'ER SHEVA ISRAEL DIPHENHYDRAMINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA METFORMIN SR GRADE 70% AS MANUFACTURED IN MAHARASHTRA INDIA ZOLEDRONIC ACID MONOHYDRATE (ESUB) TELMISARTAN AS MANUFACTURED IN GUJARAT INDIA RENOLIT SOLMED SPECIALTY PP/PVC-BASED MULTILAYER TUBING AS MANUFACTURED IN ENKHUIZEN THE NETHERLANDS ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA GLYCOPYRROLATE USP ( ESUB ) AS MANUFACTURED IN MALVERN PA CSA SALT OF CLOPIDOGREL AS MANUFACTURED IN GUJARAT INDIA MONTELUKAST SODIUM AS MANUFACTURED IN ANDHRA PRADESH INDIA

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4Q2012EXCEL DMF# 20581 A 20582 20583 A 20584 20585 A 20586 A 20587 20588 20589 20590 20591 20592 20593 20594 A 20595 20596 A 20597 20598 A 20599 20600 I 20601 20602 I 20603 A 20604 20605 A 20606 20607 20608 A 20609 20610 20611 A A A II III III 6/13/2007 6/8/2007 6/8/2007 AARTI INDUSTRIES LTD 3M DRUG DELIVERY SYSTEMS 3M DRUG DELIVERY SYSTEMS A A II III II 6/12/2007 6/18/2007 6/11/2007 GRANULES INDIA LTD PERFEKTUP AS ACCORD HEALTHCARE INC A II II 6/12/2007 6/6/2007 GRANULES INDIA LTD SUN PHARMACEUTICAL INDUSTRIES LTD III 5/24/2007 HUMPHREY COSBURN PLASTICS A IV III 6/5/2007 6/5/2007 ABELEI INC AMPACET CORP A IV III 5/7/2007 6/7/2007 N II 6/11/2007 A II II 6/8/2007 6/12/2007 APOTEX PHARMACHEM INC AMRI RENSSELAER INC SUB ALBANY MOLECULAR RESEARCH INC NOT AN ASSIGNED NUMBER PURAC BIOMATERIALS BUSINES UNIT OF PURAC MANTROSE HAEUSER CO INC CCC PLASTICS A A A A A A A II IV III II II II II III 6/5/2007 6/4/2007 4/26/2007 5/23/2007 6/11/2007 6/12/2007 6/12/2007 6/6/2007 II 6/4/2007 ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD ROCHE DIAGNOSTICS GMBH SHING LIH FANG ENTERPRISE CO LTD PRETIUM PACKAGING SYMRISE INC HETERO DRUGS LTD GLENMARK GENERICS LTD GLENMARK GENERICS LTD REXAM HEALTHCARE NEUENBURG GMBH A II IV 4/30/2007 6/7/2007 HUNAN JIUDIAN PHARMACEUTICAL CO LTD MALLINCKRODT INC DIRITHROMYCIN AS MANUFACTURED IN HUNAN CHINA A II II 6/7/2007 6/5/2007 HALCYON LABS PRIVATE LTD WANBURY LTD STATUS Type SUBMIT DATE II 6/6/2007 HOLDER SUBJECT PHARMACEUTICAL WORKS POLPHARMA SA TOPIRAMATE AS MANUFACTURED IN STAROGARD GDANSKI POLAND

4Q2012

BETAMETHASONE DIPROPIONATE USP AS MANUFACTURED IN GUJARAT INDIA PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN MAHARASHTRA INDIA

MAGNESIUM STEARATE (CODES 2257 & 5712) (ESUB) AS MANUFACTURED IN ST LOUIS MO CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN ZHEJIANG CHINA CARVEDILOL AS MANUFACTURED IN MANNHEIM, GERMANY EMPTY GELATIN CAPSULE AS MANUFACTURED IN TAICHUNG HSIEN TAIWAN PLASTIC PACKAGING MATERIAL AS MANUFACTURED IN PERU IL NEO HELIOPAN OS AS MANUFACTURED IN GOOSE CREEK, SC OLANZAPINE (FORM-1) AS MANUFACTURED IN ANDHRA PRADESH INDIA ROSUVASTATIN CALCIUM AS MANUFACTURED IN GUJARAT INDIA ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA NOVEL DUAL STRIP DRY POWDER INHALER AS MANUFACTURED IN NEUENBURG, GERMANY ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN ONTARIO CANADA DRONABINOL IN SESAME OIL DRUG SUBSTANCE AS MANUFACTURED IN RENSSELAER NY PURASAL S/PF 60 (SODIUM (S) LACTATE SOLUTION) AS MANUFACTURED IN BARCELONA AND THE NETHERLANDS MANTROCEL E-4000 AS MANUFACTURED IN ZHEJIANG CHINA WHITE MB20-9203 POLYETHYLENE COLUR CONCENTRATE AS MANUFACTURED IN ONTARIO CANADA 177A44 N&A ORANGE FLAVOR AS MANUFACTURED IN NORTH AURORA IL AMPACET 110806-K SITE 06 POLYETHYLENE MASTERBATCH AS MANUFACTURED IN RAYONG THAILAND 70/400 WHITE ROUND RING TOP F/RIBBED PP CAP AS MANUFACTURED IN ONTARIO CANADA BROMPHENIRAMINE MALEATE USP AS MANUFACTURED IN HYDERABAD INDIA IBANDRONATE MONOSODIUM MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA INDIA COMPRESSO IBU 66S AS MANUFACTURED IN RANGA REDDY INDIA TUBE PACKAGING FOR DRUG PRODUCTS AS MANUFACTURED IN ISTANBUL TURKEY ANHYDROUS DOCETAXEL AS MANUFACTURED IN QUEBEC CANADA AND NORTH BRUNSWICK NJ BUDESONIDE AS MANUFACTURED IN MAHARASHTRA INDIA COTRAN 9706 9% EVA FILM AS MANUFACTURED IN BROOKINGS SD COTRAN 9705 9% EVA FILM AS MANUFACTURED IN BROOKINGS SD

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4Q2012EXCEL DMF# 20612 I 20613 A 20614 20615 20616 20617 20618 20619 20620 A 20621 A 20622 20623 20624 20625 20626 20627 20628 A 20629 A 20630 20631 20632 20633 A 20634 20635 20636 20637 20638 20639 20640 20641 20642 A 20643 20644 A 20645 A II 5/20/2007 JIANGSU NHWA PHARMACEUTICAL CO LTD GABAPENTIN AS MANUFACTURED IN JIANGSU CHINA A IV II 6/15/2007 6/28/2007 A A A A I A A A II II II II II II II II III 6/27/2007 6/20/2007 6/20/2007 6/27/2007 6/27/2007 6/23/2007 6/15/2007 6/29/2007 6/22/2007 ZHEJIANG NHU CO LTD ACS DOBFAR SPA ACS DOBFAR SPA TAIHO PHARMACEUTICAL CO LTD RANBAXY LABORATORIES LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD JIANGSU HENGRUI MEDICINE CO LTD BAADE ENDRULAT PAPIERVERARBEITUNG GMBH RANK ORGANICS CHEMICAL PVT LTD VITAMIN E OIL AS MANUFACTURED IN ZHEJIANG CHINA I A A III III II II 6/25/2007 6/18/2007 6/26/2007 6/26/2007 CIBA SPECIALTY CHEMICALS KUKJE GLASS CO LTD INOGENT LABORATORIES PRIVATE LTD II 6/22/2007 I A A A A A IV II III II II II III 6/19/2006 6/20/2007 6/18/2007 6/19/2007 6/22/2007 6/22/2007 6/20/2007 ROHM AND HAAS CO SANOFI AVENTIS CHIMIE LABLABO MYLAN LABORATORIES LTD EUTICALS SPA CATALENT PHARMA SOLUTIONS LLC NEUTRAL GLASS AND ALLIED INDUSTRIES PRIVATE LTD AUROBINDO PHARMA LTD II 7/5/2007 IPCA LABORATORIES LTD C A I I A A II II II III III III II 6/11/2007 6/15/2007 6/18/2007 6/6/2007 6/13/2007 6/8/2007 7/19/2007 XELLIA PHARMACEUTICALS APS QILU TIANHE PHARMACEUTICAL CO LTD WUHAN SHIJI PHARMACEUTICAL CO LTD ROLLPRINT PACKAGING PRODUCTS INC RICON COLORS 3M DRUG DELIVERY SYSTEMS IPCA LABORATORIES LTD II 6/15/2007 MEGAFINE PHARMA P LTD STATUS Type SUBMIT DATE III 5/31/2007 HOLDER AMPACET CORP SUBJECT

4Q2012

AMPACET 111708 BLUE WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE IN PYRANTEL PAMOATE (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN NASHIK INDIA VANCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA HYDROXYUREA USP (NON-STERILE BULK) AS MANUFACTURED IN SHANDONG CHINA POTASSIUM CHLORIDE AS MANUFACTURED IN WUHAN CHINA RPP# 32-2210B AS MANUFACTURED IN ADDISON IL FDA AMBER CPT-B2899-3 AS MANUFACTURED IN WEST CHICAGO IL M2878 POLYETHYLENE FILM AS MANUFACTURED IN BROOKINGS SD NABUMETONE USP, PROCESS II (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA. METHYLPHENIDATE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA. RODERM SOLVENT ACRYLIC ADHESIVES AS MANUFACTURED IN PIEDMENT SC NALTREXONE HYDROCHLORIDE AS MANUFACTURED IN ARAMON FRANCE SILLAGE AIRLESS PUMP AND BOTTLE AS MANUFACTURED IN ANNEMASSE FRANCE ENROFLOXACIN USP AS MANUFACTURED IN ANDHRA PRADESH INDIA ERGOLOID MESYLATES USP AS MANUFACTURED IN ROZZANO MI ITALY MICONAZOLE 1200 MG SOFTGELS AS MANUFACTURED IN ST PETERSBURG FL GLASS VIALS AND BOTTLES AS MANUFACTURED IN GUJARAT INDIA ROSUVASTATIN CALCIUM (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA IRGAGUARD B7000 AS MANUFACTURED IN OSAKA JAPAN GLASS VIALS & GLASS AMPOULES AS MANUFACTURED IN CHOONG NAM-DO KOREA TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN HYDERABAD INDIA

PHARMACEUTICAL WORKS POLPHARMA SA P-242624 AS MANUFACTURED IN STAROGARD GDANSKI POLAND

CEFOXITIN SODIUM USP STERILE 100 GRAMS AS MANUFACTURED IN MILANO ITALY CEFTRIAXONE SODIUM USP STERILE 100 GRAMS WM-1-DAITO INTERMEDIATE FOR CDHP AS MANUFACTURED IN TOYAMA JAPAN LAMIVUDINE (FORM I) AS MANUFACTURED IN PUNJAB INDIA ZOLMITRIPTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA TADALAFIL AS MANUFACTURED IN ANDHRA PRADESH INDIA EXTRACT OF CYCLAMEN EUROPAEUM AS MANUFACTURED IN TBILISI GEORGIA CLOSURE LINERS MANUFACTURED IN HAMBURG, GERMANY SODIUM STEARYL FUMARATE AS MANUFACTURED IN THANE INDIA

NINGXIA QIYUAN PHARMACEUTICAL CO LTD ERYTHROMYCIN THIOCYANATE AS MANUFACTURED IN NINGXIA CHINA

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4Q2012EXCEL DMF# 20646 20647 20648 20649 20650 20651 20652 20653 20654 20655 A 20656 I 20657 A 20658 C 20659 A 20660 A 20661 A 20662 20663 A 20664 A 20665 20666 20667 A 20668 20669 20670 20671 A 20672 20673 20674 20675 A 20676 A II 7/11/2007 INDUSTRIALE CHIMICA SRL A A A II III II II 7/6/2007 6/13/2007 7/13/2007 7/12/2007 USV LIMITED WIPAK OY HARMAN FINOCHEM LTD NATCO PHARMA LTD A A A IV II III II 6/19/2007 7/11/2007 6/18/2007 7/12/2007 ARIES COMPONENTS MANUFACTURING CO MOREPEN LABORATORIES LTD BERRY PLASTICS CORP TEVA PHARMACEUTICAL INDUSTRIES LTD A A II III III 7/9/2007 6/18/2007 7/2/2007 II 6/30/2007 CHONGQING BIOCARE PHARMACEUTICAL CO LTD JIANGSU HENGRUI MEDICINE CO LTD BERRY PLASTICS CORP NAMICOS CORP DOXAZOSIN MESYLATE USP AS MANUFACTURED IN CHONGQING CHINA OXALIPLATIN AS MANUFACTURED IN JIANGSU CHINA GPWN60 HS AS MANUFACTURED BY BERRY PLASTICS. A II IV 7/9/2007 6/27/2007 CHEMPACIFIC CORP CRODA INC II 8/2/2007 CHEMWERTH INC II 7/6/2007 FRESENIUS KABI ONCOLOGY LTD II 7/9/2007 HETERO DRUGS LTD II 6/20/2007 ZHEJIANG HISUN PHARMACEUTICAL CO LTD DACTINOMYCIN USP AS MANUFACTURED IN ZHEJIANG CHINA III 7/6/2007 II 7/18/2007 STATUS Type SUBMIT DATE A A A A A I A A A II III III II II II III III II II 6/26/2007 6/28/2007 6/28/2007 6/29/2007 7/6/2007 6/25/2007 6/21/2007 6/21/2007 7/3/2007 7/2/2007 HOLDER SUN PHARMACEUTICAL INDUSTRIES LTD POLYONE CORP POLYONE CORP FERMION OY CADILA HEALTHCARE LTD ALEMBIC PHARMACEUTICALS LTD 3M DRUG DELIVERY SYSTEMS 3M DRUG DELIVERY SYSTEMS FINE CHEMICALS CORP PTY LTD SHANDONG NEW TIME PHARMACEUTICAL CO LTD JIANGSU JIWA RINTECH PHARMACEUTICAL CO LTD DYNEON GMBH & CO KG SUBJECT METOPROLOL SUCCINATE USP AS MANUFACTURED IN MAHARASHTRA INDIA CC10042428WE TP GREEN AS MANUFACTURED IN ELK GROVE VILLAGE, IL CC00018501WE AS MANUFACTURED IN GLENDALE AZ IRINOTECAN HYDROCHLORIDE AS MANUFACTURED IN OULU, FINDLAND

4Q2012

CLOPIDOGREL BISULFATE USP (FORM-I) AS MANUFACTURED IN GUJARAT INDIA ALENDRONATE SODIUM USP AS MANUFACTURED IN GUJARAT INDIA 3M PACKAGING FILM PF200CD AS MANUFACTURED IN DECATUR AL 3M PACKAGING FILM LF400M AS MANUFACTURED IN COTTAGE GROVE MN ROPIVACAINE HYDROCHLORIDE AS MANUFACTURED IN CAPE TOWN SOUTH AFRICA MYCOPHENOLATE MOFETIL AS MANUFACTURED IN SHANDONG CHINA RISPERIDONE EP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA. TFR 1105 PTFE AS MANUFACTURED IN BURGKIRCHEN FEDERAL REPUBLIC OF GERMANY

VALACICLOVIR HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA ANASTROZOLE (ESUB) AS MANUFACTURED IN WEST BENGAL INDIA KETOTIFEN HYDROGEN FUMARATE (ESUB) AS MANUFACTURED BY CHEMCON GMBH IN FREIBURG GERMANY FOR CHEMWERTH INC. CHP010 DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE MD SUPER REFINED POLYETHYLENE GLYCOL 300 NF AS MANUFACTURED IN MILL HALL PA

CLEANING OF GLASS VIALS AND OTHER CONTAINER CLOSURE SYSTEMS FOR PACKAGING DRUG PRODUCTS AS MANUFACTURED IN SHIGA, JAPAN. EXCIPIENT MARKING SOLUTION AS MANUFACTURED IN MAHARASHTRA, INDIA. LORATADINE (PROCESS 2) U.S.P. AS MANUFACTURED IN HIMACHAL PRADESH, INDIA. BNF60 AS MANUFACTURED BY BERRY PLASTICS ROSUVASTATIN CALCIUM (BULK) AS MANUFACTURED IN BE'ER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD ATOVAQUONE USP AS MANUFACTURED IN MAHARASHTRA, INDIA. APET 500 AS MANUFACTURED IN NASTOLA, FINLAND. MEPROBAMATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA. ONDANSETRON HYDROCHLORIDE (INJECTABLE GRADE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. DROSPIRENONE AS MANUFACTURED IN SORONNO (VARESE), ITALY.

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4Q2012EXCEL DMF# 20677 A 20678 A 20679 I 20680 A 20681 A 20682 A 20683 A 20684 A 20685 20686 A 20687 20688 20689 A 20690 A 20691 III 7/10/2007 STYROLUTION KOLN GMBH III 7/16/2007 LOPAREX LLC A A II II III 7/12/2007 7/13/2007 7/12/2007 DAICEL CORPORATION BIOFIRST PHARMACEUTICALS LLC ROLLS PACK PVT LTD BENZINDENE TRIOL AS MANUFACTURED IN NIIGATA, JAPAN. GLYCOPYRROLATE AS MANUFACTURED IN CORPUS CHRISTI, TX. C II II 7/13/2007 7/15/2007 APOTEX PHARMACHEM INDIA PVT LTD DIVIS LABORATORIES LTD II 7/12/2007 SYMBIOTEC PHARMALAB LTD III 5/24/2007 SCANDOLARA SPA II 7/16/2007 II 7/13/2007 VITALIFE LABORATORIES DIV ARCH PHARMALABS LTD CILAG AG II 8/16/2007 CIPLA LTD II 11/7/2007 CIPLA LTD II 7/13/2007 STATUS Type SUBMIT DATE II 7/2/2007 HOLDER ZHEJIANG NEO DANKONG PHARMACEUTICAL CO LTD NATCO PHARMA LTD SUBJECT

4Q2012

ROSUVASTATIN CALCIUM INTERMEDIATE (RJS3) AS MANUFACTURED IN TAIZHOU, CHINA. GRANISETRON HYDROCHLORIDE (INJECTABLE GRADE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. MYCOPHENOLATE MOFETIL BP/PH. EUR. (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. TRIMETAZIDINE DIHYDROCHLORIDE BP/PH.EUR. (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. TRANDOLAPRIL EP AS MANUFACTURED IN HARYANA, INDIA. DRONABINOL DRUG SUBSTANCE IN SESAME OIL AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND. COLLAPSIBLE PLASTIC TUBES FOR PHARMACEUTICAL USE AS MANUFACTURED IN ASCOLI PICEBO, ITALY. MOMETASONE FUROATE USP (MICRONISED) AS MANUFACTURED IN MADHYA PRADESH, INDIA. GATIFLOXACIN HEMIHYDRATE AS MANUFACTURED IN BANGALORE, INDIA. BOC COR SUCCINATE (INTERMEDIATE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA.

TAILOR MADE LAMINATED ALUMINIUM BAGS FOR DRUG PACKAGING AS MANUFACTURED IN MUMBAI, INDIA. GRADE 27246 D 2.0 CL PET 8400E/000, GRADE 27441 D 3.0 CL PET 8400E/000 AND GRADE 28924 D 3.0 CL BOP 8400E/000 AS MANUFACTURED IN WILLOWBROOK, IL; IOWA CITY, IA; EDEN, NC; CULLMAN, AL; HAMMOND, WI. LUSTRAN ABS M 205FC 000000, 011220, 100776, 300890 AND 501238 AS MANUFACTURED BY INEOS ABS (DEUTSCHLAND) GMBH IN KOLN-WORRINGEN, GERMANY; ALBIS PLASTIC GMBH IN HAMBURG, GERMANY; ALBIS UK LTD IN CHESHIRE, U.K.; AND E.P. COMPOUNDING S.L. AND INEOS ABS (SPAIN) S.L. IN TARRAGONA, SPAIN FOR INEOS ABS USA CORP

A 20692 A 20693 20694 A 20695 A 20696 20697 20698 A 20699 A 20700 A III 7/16/2007 AMPACET CORP II 7/18/2007 NAVINTA LLC A N II 7/16/2007 II 7/9/2007 ESTEVE QUIMICA SA NOT AN ASSIGNED NUMBER FRESENIUS KABI ANTI INFECTIVES SRL III 7/17/2007 FPC FLEXIBLE PACKAGING CORP A IV III 9/19/2007 7/17/2007 II 10/16/2007

CHINOIN PHARMACEUTCIAL AND CHEMICAL HYDROXYCHLOROQUINE SULFATE AS MANUFACTURED IN BUDAPEST, HUNGARY WORKS CO LTD IDEAL CURES PVT LTD INSTACOAT COLOUR AS MANUFACTURED IN THANE, INDIA BILCARE LTD BILCARE SINGAPORE MONO AND MULTILAYERED PHARMACEUTICAL ACKAGING FILMS AS MANUFACTURED IN SINGAPORE. SOFT CHEW INNERWRAP FPC SPECIFICATION 32700, 32701X AND SOFT CHEW OUTWRAP FPC SPECIFICATION 47500X AS MANUFACTURED IN ONTARIO, CANADA. PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN GIRONA, SPAIN. CEFOXITIN SODIUM (STERILE) DRUG SUBSTANCE AS MANUFACTURED IN ROVIGO, ITALY. SODIUM 4-PHENYLBUTYRATE AS MANU FACTURED IN MAHARASHTRA, INDIA FOR NAVINTA LLC AMPACET 172535 GREEN POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA. Page 621

4Q2012EXCEL DMF# 20701 20702 A 20703 20704 20705 20706 A 20707 A 20708 A 20709 A 20710 20711 20712 20713 20714 I 20715 A 20716 I 20717 A 20718 20719 20720 A 20721 A 20722 20723 20724 A 20725 A 20726 A 20727 20728 A A II II 8/16/2007 7/26/2007 CONCORD BIOTECH LTD RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA II 7/26/2007 PURAC II 7/24/2007 A A II II II 6/20/2007 6/20/2007 7/26/2007 SAI PHYTOCEUTICALS PVT LTD SAI PHYTOCEUTICALS PVT LTD LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LTD SYNKEM SAS III 7/30/2007 LAMINATED TUBES ITALIA SPA A A III III III 7/23/2007 7/26/2007 7/20/2007 II 7/9/2007 II 4/25/2007 II 7/26/2007 A A A A III II II II II 7/9/2007 4/24/2008 7/25/2007 7/24/2007 7/23/2007 PROMENS SA CIPLA LTD MSN LABORATORIES LTD APOTEX PHARMACHEM INC II 7/20/2007 CHEMWERTH INC II 7/18/2007 AUROBINDO PHARMA LTD II 7/10/2007 I A A II II II II 7/19/2007 7/11/2007 7/18/2007 7/20/2007 RANBAXY LABORATORIES LTD CADILA PHARMACEUTICALS LTD CHANGZHOU PHARMACEUTICAL FACTORY SUZHOU NUMBER 4 PHARMACUTICAL FACTORY RP SCHERER GMBH & CO. KG STATUS Type SUBMIT DATE A III III 7/31/2007 7/3/2007 HOLDER DYNIC USA CORP PENN COLOR INC SUBJECT NK22 THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR.

4Q2012

COLOR CONCENTRATE 66G1324 ECO GREEN PETG AS MANUFACTURED IN HATFIELD, PA. ZIDOVUDINE USP DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA. ALEDRONATE SODIUM (ESUB) AS MANUFACTURED IN GUJARAT, INDIA. ROSUVASTATIN CALCIUM AS MANUFACTURED IN JIANGSU PROVINCE, CHINA. QUETIAPINE FUMARATE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA. TIPRANAVIR CAPSULES 250 MG (IMPRINT) AS MANUFACTURED IN EBERBACH, FEDERAL REPUBLIC OF GERMANY. EMTRICITABINE (NON-STERILE) DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ARGATROBAN HYDRATE (NON-STERILE BULK) DRUG SUBSTANCE AS MANUFACTURED IN FREIBURG, GERMANY FOR CHEMWERTH INC TABLET CONTAINERS AS MANUFACTURED IN OYONNAX, FRANCE EFAVERINZ (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA. ROSUVASTATIN CALCIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA. RAMIPRIL USP AS MANUFACTURED IN BRANTFORD, CANADA.

CSPC ZHONGRUN PHARMACEUTICAL INNER PENICILLIN G POTASSIUM CRUDE (ESUB) AS MANUFACTURED IN INNER MONGOLIA, MONGOLIA CO LTD CHINA. LUITPOLD PHARMACEUTICALS INC SODIUM THIOSULFATE INJECTION, USP 25% ML VIAL AS MANUFACTURED IN SHIRLEY, NY. ZHEJIANG HUAHAI PHARMACEUTICAL CO LOSARTAN POTASSIUM, USP AS MANUFACTURED IN ZHEJIANG, CHINA. LTD SAFC BIOSCIENCES INC EX-CELL(TM) CD CHO (MODIFIED), SERUM-FREE MEDIUM, CHEMICALLY DEFINED W/O GLUCOSE, W/O L-GLUTAMINE, W/O HYPOXANTHINE, W/O THYMIDINE AS MANUFACTURED IN DENVER, PA BERRY PLASTICS CORP PLASTIAPE SPA DALAU LTD PRODUCT 15149-28 AS MANUFACTURED IN COLUMBUS, GA CONCEPT1 DRY POWDER INHALATION DEVICE AS MANUFACTURED IN LECCO, ITALY. COMPONENTS FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN ESSEX, U.K. LAMINATED TUBES FOR PHARMACEUTICAL USE AS MANUFACTURED IN CISTERNA DI LATINA, ITALY. DOCETAXEL TRIHYDRATE AS MANUFACTURED IN MADHYA PRADESH, INDIA. TOPOTECAN HYDROCHLORIDE AS MANUFACTURED IN MADHYA PRADESH, INDIA. TOBRAMYCIN (NON-STERILE, BULK FORM) AS MANUFACTURED IN GUANGDONG, CHINA. FENOFIBRATE INTERMEDIATE DRUG SUBSTANCE AS MANUFACTURED IN CHENOVE, FRANCE. L(+)LACTIC ACID AS MANUFACTURED BY PURAC BIOQUIMICA IN BARCELONA, SPAIN FOR PURAC PRAVASTATIN SODIUM AS MANUFACTURED IN AHMEDABAD, INDIA. KETOROLAC TROMETHAMINE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN CAMPOVERDE DI APRILIA, ITALY.

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4Q2012EXCEL DMF# 20729 A 20730 20731 20732 20733 A 20734 20735 20736 20737 A 20738 A 20739 A 20740 20741 20742 20743 A 20744 20745 20746 A 20747 20748 20749 A 20750 A 20751 A 20752 A 20753 A 20754 20755 A 20756 I 20757 20758 A A V II 7/20/2007 8/7/2007 PATHEON ITALIA SPA CHONGQING DAXIN PHARMACEUTICAL CO LTD II 8/7/2007 MATRIX LABORATORIES LTD A II II 7/30/2007 8/3/2007 II 8/6/2007 ORCHID CHEMICALS AND PHARMACEUTICALS LTD ALEMBIC PHARMACEUTICALS LTD MSN PHARMACHEM PVT LTD II 7/28/2007 II 7/27/2007 II 12/7/2007 TITAN PHARMACEUTICAL CO LTD GUANGDONG ZHEJIANG NEO DANKONG PHARMACEUTICAL CO LTD SINOPEP PHARMACEUTICALS INC I A II III II 8/2/2007 6/29/2007 8/2/2007 MALLINCKRODT INC AMCOR FLEXIBLES INDIA PVT LTD CHEMWERTH INC I C IV II II 10/19/2007 7/31/2007 8/3/2007 A A A II III II II 7/27/2007 7/20/2007 7/30/2007 7/25/2007 ZACH SYSTEM SPA ROLLPRINT PACKAGING PRODUCTS INC FLAMMA SPA ST GOBAIN PERFORMANCE PLASTICS FRANCE HERCULES INC MACFARLAN SMITH LTD SMS PHARMACEUTICALS LTD II 8/1/2007 II 8/1/2007 ST GOBAIN PERFORMANCE PLASTICS FRANCE JIANGSU HENGRUI MEDICINE CO LTD A A A II II II II 7/31/2007 7/30/2007 7/30/2007 7/26/2007 A A A II III IV II 6/28/2007 7/26/2007 7/30/2007 7/18/2007 STATUS Type SUBMIT DATE II 7/16/2007 HOLDER JOHNSON MATTHEY PHARMACEUTICAL MATERIALS TEVA PHARMACEUTICAL INDUSTRIES LTD LEVOSIL SPA CYDEX PHARMACEUTICALS A LIGAND CO ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD GLENMARK GENERICS LTD INFA SA AMINO CHEMICALS LTD CERBIOS PHARMA SA SUBJECT OXYCODONE HYDROCHLORIDE (MS PROCESS) AS MANUFACTURED IN WEST DEPTFORD,NJ. CEFDINIR HYDRATE AS MANUFACTURED IN MEXICO, CO. SILICA GEL DESICCANT BAG WITH TYVEK(R) ENVELOPE

4Q2012

CAPTISOL R EXCIPIENT AS MANUFACTURED IN LISBON, PORTUGAL FOR CYDEX INC QUETIAPINE HEMIFUMARATE DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG, CHINA. FLUCONAZOLE USP AS MANUFACTURED IN GUJARAT, INDIA. TERCONAZOLE AS MANUFACTURED IN MURCIA, SPAIN FOR AEOLUX LTD IMIQUIMOD AS MANUFACTURED IN MARSA, MALTA. VENTRUX ME30 DRUG SUBSTANCE AS MANUFACTURED IN BARBENGO, SWITZERLAND. PHARMEDR BPT BIOCOMPATIBLE TUBING MANUFACTURED IN CHARNY, FRANCE IRINOTECAN HYDROCHLORIDE (NON-STERILE BULK) DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA. DORZOLAMIDE HYDROCHLORIDE AS MANUFACTURED IN LONIGO, ITALY. RPP #26-1220 - PACKAGING MATERIAL AS MANUFACTURED IN ADDISON, IL. SULINDAC AS MANUFACTURED IN BERGAMO, ITALY. TYGON(R) S-50-HL MEDICAL/SURGICAL TUBING MANUFACTURED IN CHARNY, FRANCE. AQUARIUS(TM) COATINGS SYSTEMS AS MANUFACTURED IN WILMINGTON, DE NALOXONE HYDROCHLORIDE AS MANUFACTURED IN SCOTLAND, UNITED KINGDOM. SUMATRIPTAN SUCCINATE (ALTERNATIVE SYNTHESIS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA. LEVORPHANOL BASE AS MANUFACTURED IN ST. LOUIS, MO. FLEXIBLE PACKAGING MATERIAL AS MANUFACTURED IN MAHARASHTRA, INDIA. ISRADIPINE USP, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN SHANGHAI, CHINA FOR CHEMWERTH INC CEFUROXIME AXETIL DRUG SUBSTANCE AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA ROSUVASTATIN CALCIUM INTERMEDIATE (R1.5) AS MANUFACTURED IN TIZHOU, CHINA. DESMOPRESSIN ACETATE, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN HAIKOU, CHINA. RIVASTIGMINE HYDROGEN TARTRATE AS MANUFACTURED IN MAHARASHTRA, INDIA. AZITHROMYCIN DIHYDRATE USP AS MANUFACTURED IN GUJARAT, INDIA MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. LOPINAVIR (LOR) AS MANUFACTURED BY ASTRIX LABORATORIES LTD IN ANDHRA PRADESH, INDIA FOR MATRIX LABORATORIES LTD. STERILE AREA 1 DEPARTMENT AT MONZA FACILITY IN MILAN, ITALY. MYCOPHENOLATE MOFETIL, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, CHINA. Page 623

4Q2012EXCEL DMF# 20759 A 20760 20761 A 20762 20763 20764 A 20765 A 20766 A 20767 A 20768 20769 A 20770 20771 A 20772 A 20773 A 20774 A 20775 20776 A 20777 20778 20779 A 20780 A 20781 20782 A 20783 20784 20785 20786 20787 A A A A A III II II II II 8/6/2007 8/7/2007 8/1/2007 8/14/2007 8/23/2007 A II II 8/21/2007 8/17/2007 NATCO PHARMA LTD ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTD PENN COLOR INC FIS FABBRICA ITALIANA SINTETICI SPA KEKULE PHARMA LTD SUN PHARMACEUTICAL INDUSTRIES LTD JOHNSON MATTHEY PHARMACEUTICAL MATERIALS II 8/17/2007 A A III II II 8/1/2007 8/17/2007 8/16/2007 EXCEL PACK LTD TONIRA PHARMA LTD JOHNSON MATTHEY PHARMACEUTICAL MATERIALS DR REDDYS LABORATORIES LTD A II III 8/16/2007 8/10/2007 II 7/18/2007 YICHANG HUMANWELL PHARMACEUTICAL CO LTD APICORE LLC LISA AMPOULES AND VIALS PVT LTD III 8/7/2007 IV 8/13/2007 MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS COLORTECH INC I II II 8/6/2007 8/20/2007 STANDARD CHEM AND PHARM CO LTD IPCA LABORATORIES LTD A III II 8/1/2007 8/10/2007 II 8/10/2007 HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD PROMENS SA CADILA HEALTHCARE LTD II 7/31/2007 AUROBINDO PHARMA LTD II 8/9/2007 LEK PHARMACEUTICALS DD A A IV II II 8/6/2007 7/31/2007 8/8/2007 HINDUSTAN PHOSPHATES PVT LTD WOCKHARDT LTD NOF CORP A II II 8/7/2007 7/30/2007 EUTICALS SPA TAI HENG INDUSTRY CO LTD STATUS Type SUBMIT DATE II 7/31/2007 HOLDER CKD BIO CORP SUBJECT

4Q2012

ACARBOSE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN KYUNGGIDO, SOUTH KOREA. ARGATROBAN DRUG SUBSTANCE AS MANUFACTURED IN ROZZANO, ITALY. LETROZOLE USP AS MANUFACTURED IN JIANGSU, CHINA FOR TAI HENG INDUSTRY CO LTD CALCIUM PHOSPHATES AS MANUFACTURED IN INDORE (M.P.), INDIA. PANTOPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA. HSPC (PURIFIED HYDROGENATED SOY PHOSPHATIDYLCHOLINE) AS MANUFACTURED IN HYOGO, JAPAN. ROSUVASTATIN CALCIUM DRUG SUBSTANCE AS MANUFACTURED IN MENGES, SLOVENIA. GLYCOPYRROLATE USP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. MUPIROCIN, NON-STERILE BULK FORM AS MANUFACTURED IN HANGZHOU, CHINA. EASYLOCK AS MANUFACTURED IN OYONNAX, FRANCE. ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN GUJARAT, INDIA. DOXAZOSIN MESYLATE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN. ONDANSETRON HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA. 711497 NATURAL LEMON LIME FLAVOR WONF, EXCIPIENT COLORANT FLAVOR AS MANUFACTURED IN CLARK, NJ. 11430-18 ANTISTAT WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN AND BRAMPTON, CANADA. FENTANYL CITRATE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN YICHANG, CHINA. MOLINDONE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN SOMERSET, NJ. NEUTRAL GLASS AMPOULES & TUBULAR VIALS AS MANUFACTURED IN ANDHRA PRADESH, INDIA. INDUCTION SEALING WADS AS MANUFACTURED IN NEW DELHI, INDIA. MEFENAMIC ACID AS MANUFACTURED IN GUJARAT, INDIA. DANTROLENE SODIUM (DTE) AS MANUFACTURED IN CONSHOHOCKEN, PA. VARDENAFIL HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. RIZATRIPTAN BENZOATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. OXO-ACID DIPA SALT, DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. PLASTIC COLORANTS AS MANUFACTURED IN HATFIELD, PA BENZYL HYDRAZINE MSA (FIS0181) AS MANUFACTURED IN VICENZA, ITALY. BICALUTAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. ALENDRONATE SODIUM USP AS MANUFACTURED IN GUJARAT, INDIA. CODEINE PHOSPHATE USP AS MANUFACTURED IN WEST DEPTFORD, NJ.

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4Q2012EXCEL DMF# 20788 20789 20790 20791 20792 20793 20794 20795 20796 20797 20798 20799 20800 20801 20802 20803 20804 20805 20806 20807 20808 20809 20810 A 20811 I 20812 I 20813 20814 A 20815 20816 A 20817 20818 20819 20820 20821 20822 20823 A A A A A A A V II II II II II II 8/15/2007 8/29/2007 8/6/2007 8/23/2007 8/29/2007 8/29/2007 8/28/2007 A III II 8/28/2007 8/24/2007 ZELLER PLASTIK MEXICO SHANDONG NEW TIME PHARMACEUTICAL CO LTD QSV BIOLOGICS LTD AMINO CHEMICALS LTD CADILA PHARMACEUTICALS LTD CADILA PHARMACEUTICALS LTD SYMBIOTEC PHARMALAB LTD IBA MOLECULAR NA BIONORICA AG A II II 8/28/2007 8/28/2007 AARTI DRUGS LTD SHASUN PHARMA SOLUTIONS LTD II 8/23/2007 SANOFI CHIMIE II 8/27/2007 ELAN DRUG DELIVERY INC STATUS Type SUBMIT DATE A A A A A A A A A A A A A A A A A A A A A A II II IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV II 8/21/2007 8/22/2007 8/21/2007 8/21/2007 8/21/2007 8/21/2007 8/21/2007 8/21/2007 8/21/2007 8/21/2007 8/21/2007 8/21/2007 8/21/2007 8/20/2007 8/21/2007 8/22/2007 8/21/2007 8/21/2007 8/21/2007 8/21/2007 8/21/2007 8/21/2007 8/22/2007 HOLDER BACHEM SA GUFIC BIOSCIENCES LTD MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA MASTERTASTE SPA SCINOPHARM TAIWAN LTD SUBJECT

4Q2012

PERINDOPRIL TERT-BUTYLAMINE AS MANUFACTURED IN VIONNAZ, SWITZERLAND. LIDOCAINE USP AS MANUFACTURED IN GUJARAT, INDIA. 58.3514.2P PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 58.3520.1P PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 58.3536.1P PHA LIME FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 20.4561.IP PHA BLACKCURRANT FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 20.4568.1G PHA STRAWBERRY FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 20.4570.3P PHA PASSION FRUIT FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 58.4262.2L PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 20.4564.2P PHA GRAPE FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 20.4563.UL PHA CHERRY FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 20.4557.1G PHA MIXED BERRIES FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 20.4554.CP PHA MILK FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 58.3754.1P PHA SPEARMINT FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 58.3964.2P PHA PEPPERMINT FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 58.3748.UW PHA PEPPERMINT FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 20.4573.5P PHA VANILLA FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 20.4571.1V PHA WINTERGREEN FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 20.4579.1P PHA MIXED BERRIES FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 20.4566.CP PHA STRAWBERRY FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 20.4582.2P PHA SOUR CHERRY FLAVOUR AS MANUFACTURED IN MOZZO, ITALY 58.3478.1P PHA ORANGE FLAVOUR AS MANUFACTURED IN MOZZO, ITALY TOPOTECAN HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN TAINAN, TAIWAN R.O.C. N1296 (PANZEM) NANOCRYSTAL POWDER FOR ORAL SUSPENSION AS MANUFACTURED IN KING OF PRUSSIA, PA. SATAVAPTAN PHOSPHATE MONOHYDRATE DRUG SUBSTANCE AS MANUFACTURED IN SISTERON, FRANCE. NIMESULIDE AS MANUFACTURED IN MAHARASHTRA, INDIA. KETONE BISULFITEADDUCT (KBA) DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN NORTHUMBERLAND, U.K. TOOTHPASTE FLIP TOP CAP AS MANUFACTURED IN CUAUTITLAN IZCALLI, MEXICO. ISOSORBIDE MONONITRATE (NON-STERILE, BULK FORM) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA. EDMONDON FACILITY IN ALBERTA, CANADA RABEPRAZOLE SODIUM MONOHYDRATE AS MANUFACTURED IN MARSA, MALTA. PSEUDOEPHEDRINE TANNATE AS MANUFACTURED IN GUJARAT, INDIA. DIPHENHYDRAMINE TANNATE AS MANUFACTURED IN GUJARAT, INDIA. CLOBETASOL PROPIONATE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA. (F-18)FLT AS MANUFACTURED IN STERLING, VA. DRONABINOL USP AS MANUFACTURED IN NEUMARKT, FEDERAL REPUBLIC OF GERMANY

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4Q2012EXCEL DMF# 20824 20825 20826 C 20827 A 20828 V 8/22/2007 DEET JOINT VENTURE DEET TASK FORCE II 8/30/2007 STATUS Type SUBMIT DATE A A II II II 8/23/2007 8/29/2007 8/20/2007 HOLDER SUN PHARMACEUTICAL INDUSTRIES LTD MEDICHEM SA SUBJECT LITHIUM CARBONATE USP AS MANUFACTURED IN GUJARAT, INDIA.

4Q2012

RABEPRAZOLE SDOIUM (MED-201580/E) AS MANUFACTURED IN GIRONA, SPAIN

ZHEJIANG CHIRAL MEDICINE CHEMICALS CO GABAPENTIN AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. LTD CENTAUR PHARMACEUTICALS PRIVATE LTD ALPRAZOLAM USP AS MANUFACTURED IN MAHARASHTRA, INDIA. NON-CLINICAL DATA FOR N,N-DIETHYL-META-TOLUAMIDE AS MANUFACTURED BY ELGIN FINE CHEMICALS INC IN ELGIN, SC; MT HOLLY CLARIANT CORP IN MT HOLLY, NC; VERTELLUS PERFORMANCE MATERIALS INC IN GREENSBORO, NC; QINGDAO SANLI CHEM ENGINEERING TECH CO. LTD ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, CHINA TUBING BOROSILICATE GLASS CONTAINERS FOR PARENTERAL PREPARATIONS AS MANUFACTURED IN ZHEJIANG, CHINA. TUBING LOW-BOROSILICATE GLASS CONTAINERS FORPARENTERAL PREPARATIONS MANUFACTURED IN ZHEJIANG, CHINA NP-0730-PP DRUG SUBSTANCE AS MANUFACTURED IN IWATE, JAPAN FOR NIPPON CHEMIPHAR CO LTD ROCURONIUM BROMIDE USP (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA LIPOID PC 16:0/18.1 (1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE) (POPC) AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY LAMOTRIGINE USP API (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA 2-METHOXYESTRADIOL AS MANUFACTURED IN OSS, THE NETHERLANDS MELPERONE HYDROCHLORIDE AS MANUFACTURED IN PADOVA, ITALY TYGON 3350 SANITARY SILICONE TUBING AS MANUFACTURED IN CHARNY, FRANCE IS MAB-V(TM) WITH IRON CHELATE AS MANUFACTURED IN SANTA ANA, CA 30,463HCC AMBER 2% AS MANUFACTURED IN LODI, OH; HENDERSON, KY AND JACKSONVILLE, TX MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

A 20829 A 20830 A 20831 A 20832 A 20833 20834 A 20835 20836 20837 20838 A 20839 20840 A 20841 20842 I 20843 20844 20845 20846 20847 A 20848 A 20849 20850 20851 A A A II II IV 9/13/2007 9/10/2007 9/14/2007 II 9/13/2007 A A A A II II II III II 9/12/2007 9/12/2007 9/12/2007 8/28/2007 9/10/2007 A II II 9/7/2007 10/11/2007 DR REDDYS LABORATORIES LTD A II III 9/6/2007 9/6/2007 A I A II II II II 9/10/2007 9/6/2007 7/27/2007 9/3/2007 UNICHEM LABORATORIES LTD NV ORGANON LUNDBECK PHARMACEUTICALS ITALY SPA ST GOBAIN PERFORMANCE PLASTICS FRANCE IRVINE SCIENTIFIC SALES CO TEKNOR COLOR CO A II IV 9/5/2007 12/7/2007 GLAND PHARMA LTD LIPOID GMBH II 9/4/2007 III 7/20/2007 III 7/20/2007 II 4/25/2007 ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD NINGBO ZHENGLI PHARMACEUTICAL PACKING CO LTD NINGBO ZHENGLI PHARMACEUTICAL PACKING CO LTD NIPPON CHEMIPHAR CO LTD

CSPC HEBEI ZHONGRUN PHARMACEUTICAL 7-AMINOCEPHALOSPORANIC ACID (ESUB) AS MANUFACTURED IN SHIJIAZHUANG, CHINA CO LTD HARIKA DRUGS PRIVATE LTD DEXTROMETHORPHAN TANNATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA HARIKA DRUGS PRIVATE LTD HETERO LABS LTD SHINIL PHARM GLASS CO LTD PHENYLEPHRINE TANNATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA QUETIAPINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA VIALS AS MANUFACTURED IN CHUNGNAM, KOREA

CHINOIN PHARMACEUTCIAL AND CHEMICAL MISOPROSTOL DISPERSION, HPMC 1% AS MANUFACTURED IN BUDAPEST, HUNGARY WORKS CO LTD ORCHID CHEMICALS AND MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA PHARMACEUTICALS LTD AMOLI ORGANICS PVT LTD DICLOFENAC SODIUM AS MANUFACTURED IN GUJARAT, INDIA MSN LABORATORIES LTD INTERNATIONAL SPECIALTY PRODUCTS PANTOPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA ADVANTIA(TM) PRIME AS MANUFACTURED IN NORRISTOWN, PA FOR INTERNATIONAL SPECIALTY PRODUCTS

Page 626

4Q2012EXCEL DMF# 20852 I 20853 A 20854 20855 20856 20857 20858 20859 20860 A 20861 20862 20863 C 20864 20865 C 20866 A 20867 20868 C 20869 A 20870 A 20871 20872 20873 20874 A 20875 20876 A 20877 A 20878 A 20879 A 20880 20881 A A V III 9/18/2007 9/26/2007 WEST PHARMACEUTICAL SERVICES INC LCY CHEMICAL CORP II 9/21/2007 S A PHARMACHEM PVT LTD II 9/24/2007 II 9/24/2007 ORCHID CHEMICALS AND PHARMACEUTICALS LTD CHEMPACIFIC CORP A III II 9/24/2007 9/24/2007 GERRESHEIMER REGENSBURG GMBH NOF CORP A A A II III II II 9/14/2007 9/21/2007 9/21/2007 9/18/2007 JOST CHEMICAL CO GERRESHEIMER ESSEN GMBH HETERO DRUGS LTD QILU TIANHE PHARMACEUTICAL CO LTD II 9/17/2007 AUROBINDO PHARMA LTD II 9/21/2007 SCINOPHARM TAIWAN LTD A II II 9/17/2007 9/20/2007 MSN LABORATORIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD III 9/7/2007 ARGO SA PLASTIC PACKAGING A II II 9/28/2007 9/19/2007 F2 CHEMICALS LTD TEVA PHARMACEUTICAL INDUSTRIES LTD I A II II II 9/18/2007 9/17/2007 9/18/2007 DR REDDYS LABORATORIES LTD BACHEM AG TEVA PHARMACEUTICAL INDUSTRIES LTD A A A A A A II II II III III V III 9/17/2007 9/17/2007 9/17/2007 9/14/2007 9/14/2007 9/10/2007 9/10/2007 FARMAK AS FDC LTD FDC LTD POLYONE CORP POLYONE CORP AAIPHARMA SERVICES CORP ADVANCED FILMS LLC II 9/14/2007 AMBIOPHARM INC STATUS Type SUBMIT DATE II 9/10/2007 HOLDER HEC PHARM CO SUBJECT

4Q2012

AZITHROMYCIN MONHYDRATE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN HUBEI PROVINCE, CHINA BIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN AUGUSTA, SC AND SHANGHAI, CHINA FOR AMBIOPHARM INC QUETIAPINE FUMARATE AS MANUFACTURED IN OLOMOUC, CZECH REPUBLIC BRIMONIDINE TARTRATE AS MANUFACTURED IN MAHARASHTRA, INDIA DORZOLAMIDE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA CC10097644WE BLUE 286C AS MANUFACTURED IN ELK GROVE VILLAGE, IL CC00016598DR 60558JEMB AMBER AS MANUFACTURED IN ELK GROVE VILLAGE, IL STERILE MANUFACTURING FACILITY IN CHARLESTON, SC MEDICAL POUCH FILM (NX-779F-6) AS MANUFACTURED IN LAKEVILLE, MN AND VANCOUVER, WA FOR ADVANCED FILMS LLC ROCURONIUM BROMIDE AS MANUFACATURED IN ANDHRA PRADESH, INDIA ICATIBANT ACETATE AS MANUFACTURED IN BUBENDORF, SWITZERLAND BIVALIRUDIN AS MANUFACTURED IN NETANYA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD PERFLUOROBUTANE AS MANUFACTURED IN LANCASHIRE, UNITED KINGDOM PARICALCITOL AS MANUFACTURED IN BE'ER, SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD DRUG BOTTLES AND CONTAINERS AS MANUFACTURED IN KAROPI, GREECE AND BUCURESTI, ROMANIA FOR ARGO SA PLASTIC PACKAGING ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN CARONNO PERTUSELLA AND BULCIAGO, ITALY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN R.O.C. DIDANOSINE USP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA MAGNESIUM LACTATE DIHYDRATE AS MANUFACTURED IN ST. LOUIS, MO AMBER AND FLINT GLASS CONTAINERS AS MANUFACTURED IN ESSEN, GERMANY LANSOPRAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA AMIKACIN SULFATE USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN SHANDONG, CHINA CAPSULE SLEEVE AS MANUFACTURED IN PFREIMD, FEDERAL REPUBLIC OF GERMANY DPPC (DIPALMITOYL PHOSPHATIDYLCHOLINE) AS MANUFACTURED IN AMAGASAKI, JAPAN ZALEPLON AS MANUFACTURED IN MAHARASHTRA, INDIA PROCARBAZINE HYDROCHLORIDE (CHP012) DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE, MD PREGELATINIZED STARCH BP/USP AS MANUFACTURED IN DADRA & NAGAR HAVELI, INDIA WESTAR(R) READY-TO-USE (RU) STERILIZATION PROCESS IN JERSEY SHORE, PA POLYPROPLENE POLYMERS: PT231M, ST612, STM866, ST757M, ST868M, PT100 and 8461 AS MANUFACTURED IN KAOHSIUNG HSIEN, TAIWAN R.O.C. Page 627

4Q2012EXCEL DMF# 20882 20883 20884 A 20885 20886 A 20887 20888 20889 20890 A 20891 20892 A 20893 20894 A 20895 A 20896 A 20897 A 20898 20899 A 20900 A 20901 A 20902 A 20903 20904 I 20905 A 20906 A 20907 I 20908 20909 A A II II 10/3/2007 9/29/2007 II 9/7/2007 II 10/3/2007 II 9/25/2007 DONGYING TIANDONG BIOCHEMICAL INDUSTRY CO LTD SMS PHARMACEUTICALS LTD A II II 10/1/2007 10/2/2007 MYLAN LABORATORIES LTD SANOFI CHIMIE II 10/24/2007 JANSSEN PHARMACEUTICA NV III 8/18/2007 HUBEI HUAQIANG HIGH TECH CO LTD III 8/18/2007 HUBEI HUAQIANG HIGH TECH CO LTD A III III 9/20/2007 8/18/2007 BERRY PLASTICS CORP HUBEI HUAQIANG HIGH TECH CO LTD II 9/27/2007 POLYMED THERAPEUTICS INC II 11/13/2007 ABBVIE INC II 11/13/2007 ABBVIE INC A II II 9/27/2007 10/1/2007 HETERO LABS LTD NATCO PHARMA LTD A II III 9/27/2007 9/28/2007 SAFC PHARMA ZOTEFOAMS PLC A A A IV II III II 9/26/2007 9/27/2007 9/26/2007 9/24/2007 APTALIS PHARMATECH INC SANOFI AVENTIS CHIMIE RITE SYSTEMS INC AUROBINDO PHARMA LTD A II III 9/25/2007 8/31/2007 EXCELLA GMBH ROHM AND HAAS CO STATUS Type SUBMIT DATE A A II II II 9/26/2007 9/24/2007 9/26/2007 HOLDER AMINO CHEMICALS LTD OLON SPA TEVA PHARMACEUTICALS INDUSTRIES LTD SUBJECT TELMISARTAN AS MANUFACTURED IN MARSA, MALTA

4Q2012

MELPHALAN HYDROCHLORIDE AS MANUFACTURED IN SETTIMO TORINESE, ITALY TADALAFIL AS MANUFACTURED IN BEER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD R-BACLOFEN (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY ADCOTE 40-51NEF AS MANUFACTURED IN ELK GROVE VILLAGE AND RINGWOOD, IL FOR ROHM AND HAAS CO F001 GRANULATION AS MANUFACTURED IN VANDALIA, OH ALFUZOSIN HYDROCHLORIDE AS MANUFACTURED IN SISTERON, FRANCE FDA STANDARD WHITE NQT-W1367-2 AS MANUFACTURED IN MOORESVILLE, NC FELODIPINE USP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ISOSULFAN BLUE AS MANUFACTURED IN DORSET, UNITED KINGDOM PLASTAZOTE(R) - CROSSLINKED LOW DENSITY POLYETHYLENE FOAMS AS MANUFACTURED IN CROYDON, U.K. AND WALTON, KY FOR ZOTEFOAMS PLC FINASTERIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA SUMATRIPTAN SUCCINATE (INJECTABLE GRADE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA CHOLINE FENOFIBRATE DRUG SUBSTANCE AS (ESUB)MANUFACTURED IN BARCELONETA, PUERTO RICO CHOLINE FENOFIBRATE MINI-TABLET INTERMEDIATE (ESUB) AS MANUFACTURED IN BARCELONETA, PUERTO RICO AND CORK, IRELAND OXALIPLATIN, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, CHINA FOR POLYMED THERAPEUTICS INC PRODUCT 24-5-215 AS MANUFACTURED IN HOMER, LA ELASTOMERIC CLOSURES FOR LYOPHILIZED POWDERS FOR INJECTION AS MANUFACTURED IN HUBEI, CHINA ELASTOMERIC CLOSURES FOR AQUEOUS PARENTERAL PREPARATIONS AS MANUFACTURED IN HUBEI PROVINCE, CHINA ELASTOMERIC CLOSURES FOR STERILE POWDERS FOR INJECTION AS MANUFACTURED IN HUBEI PROVINCE, CHINA PALIPERIDONE PALMITATE (R092670) DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN BEERSE, BELGIUM SIMVASTATIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA SAREDUTANT SUCCINATE DRUG SUBSTANCE AS MANUFACTURED IN VERTOLAYE, FRANCE DALTEPARIN SODIUM USP AS MANUFACTURED IN SHANDONG PROVINCE, CHINA

SUMATRIPTAN USP (ALTERNATIVE SYNTHESIS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA CHANGZHOU FANGYUAN PHARMACEUTICAL AZTREONAM, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU CO LTD PROVINCE, CHINA CADILA HEALTHCARE LTD ATOVAQUONE USP AS MANUFACTURED IN GUJARAT, INDIA AUROBINDO PHARMA LTD DONEPEZIL HYDROCHLORIDE, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

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4Q2012EXCEL DMF# 20910 A 20911 20912 A 20913 A 20914 I 20915 20916 20917 A 20918 20919 20920 20921 A 20922 A 20923 I 20924 A 20925 A 20926 20927 20928 A 20929 20930 20931 I 20932 20933 A 20934 I 20935 A 20936 I IV 10/9/2007 SILESIA FLAVORS INC IV 10/8/2007 PQ CORP III 10/1/2007 T AND S BLOWMOULDING INC A II II 10/5/2007 10/11/2007 UNIMARK REMEDIES LTD SALTIGO GMBH I A II II II 10/22/2007 10/18/2007 10/8/2007 IPCA LABORATORIES LTD IPCA LABORATORIES LTD CHEMWERTH INC A A III II II 9/19/2007 10/1/2007 11/21/2007 YEONHAP GLASS CO LTD BIO 2 INC SALIENT PHARMACEUTICALS INC II 10/5/2007 CHEMWERTH INC II 10/5/2007 AMRI RENSSELAER INC II 12/17/2007 IV 10/10/2007 A A A II II II II 10/8/2007 10/5/2007 10/4/2007 10/9/2007 STERLING SRL SYMED LABS LTD PIRAMAL HEALTHCARE LTD ZHEJIANG MAOYUAN SUNFLOWER PHARMACEUTICAL CO LTD ZHEJIANG MAOYUAN SUNFLOWER PHARMACEUTICAL CO LTD IPCA LABORATORIES LTD DUTASTERIDE AS MANUFACTURED IN PERUGIA, ITALY IRON SUCROSE AS MANUFACTURED IN ANDHRA PRADESH, INDIA A A IV II II 9/25/2007 10/1/2007 9/20/2007 SIGACHI CHLORO CHEMICALS PVT LTD SMRUTHI ORGANICS LTD WANBURY LTD IV 9/21/2007 ADHESIVES RESEARCH INC III 9/21/2007 ADHESIVES RESEARCH INC A II III 10/4/2007 9/21/2007 JOHNSON MATTHEY PHARMA SERVICES ADHESIVES RESEARCH INC STATUS Type SUBMIT DATE III 9/25/2007 HOLDER CONSOLIDATED BOTTLE CORP SUBJECT

4Q2012

4 LITRE WIDEMOUTH JAR WITH HANDLE 110MM AS MANUFACTURED IN ONTARIO, CANADA FOR CONSOLIDATED BOTTLE CORP 3077.E AS MANUFACTURED IN DEVENS, MA TD-2B ADHESIVE AS MANUFACTURED BY ADHESIVES RESEARCH INC IN GLEN ROCK, PA AND ADHESIVES RESEARCH IRELAND LTD IN LIMERICK, IRELAND EC2-SN2A ADHESIVE AS MANUFACTURED BY ADHESIVES RESEARCH INC. IN GLEN ROCK, PA AND ADHESIVES RESEARCH IRELAND LIMITED IN LIMERICK, IRELAND TD-1B ADHESIVE AS MANUFACTURED BY ADHESIVES RESEARCH INC. IN GLEN ROCK, PA AND ADHESIVES RESEARCH IRELAND LIMITED IN LIMERICK, IRELAND MICRO CRYSTALLINE CELLULOSE AS MANUFACTURED IN ANDHRA PRADESH, INDIA AMLODIPINE BESILATE AS MANUFACTURED IN MAHARASHTRA, INDIA CARVEDILOL PHOSPHATE HEMIHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

TRAZODONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA POVIDONE IODINE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA POVIDONE K30 AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA CLOPIDOGREL BISULFATE USP FORM 1 (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA DIATRIZOATE SODIUM USP DRUG SUBSTANCE AS MANUFACTURED IN RENSSELAER, NY LATANOPROST, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR CHEMWERTH INC CLEAR AMPOULE & VIAL AS MANUFACTURED IN GYEONG-DO, SOUTH KOREA BIOCATALYST SUBSTANCE AS MANUFACTURED IN LIVERPOOL, TX HYDRATED CALCIUM ALUMINOSILICATE UNIFORM PARTICLE SIZE NON-SWELLING (HCAS UPSN) (ESUB) AS MANUFACTURED BY MID-CONTINENT PACKAGING INC IN ENID, OK FOR SALIENT PHARMACEUTICALS INC FLUCONAZOLE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA CARVEDILOL (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA IMIQUIMOD, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR CHEMWERTH INC TOPIRAMATE AS MANUFACTURED IN GUJARAT, INDIA N-BENZYLHYDRAZINE MSA SALT DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN LEVERKUSEN, FEDERAL REPUBLIC OF GERMANY 40ML WHITE BELL ROUND HDPE CYLINDER (RESIN SCLAIR 58A) AS MANUFACTURED IN ONTARIO, CANADA SORBOSIL(R) AC43, SYNTHETIC AMORPHOUS SILICA PRECIPITATE AS MANUFACTURED IN WARRINGTON, ENGLAND N&A CITRUS FRUIT FREEZE-TYPE FLAVOR 1100609500 AS MANUFACTURED BY SILESIA FLAVORS INC IN HOFFMAN ESTATES, IL AND SILESIA GERHARD HANKE GMBH & CO. KG IN ALLERHEILLIGEN, GERMANY FOR SILESIA FLAVORS INC.

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4Q2012EXCEL DMF# 20937 C 20938 20939 A 20940 20941 20942 A 20943 A 20944 I 20945 20946 A 20947 A 20948 20949 20950 20951 20952 20953 I 20954 20955 20956 20957 20958 A 20959 A 20960 A 20961 A 20962 A 20963 A 20964 20965 A I III 10/19/2007 II 10/22/2007 II 10/22/2007 ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD *** PENDING FILING REVIEW *** RELIANCE INDUSTRIES LTD II 10/22/2007 POLYMED THERAPEUTICS INC IV 10/11/2007 II 10/18/2007 DISHMAN PHARMACEUTICALS AND CHEMICALS LTD BASF SE A A A A IV IV IV II II 10/10/2007 10/10/2007 10/11/2007 10/18/2007 10/15/2007 ABELEI INC ABELEI INC MANE INC SANDOZ GMBH POLYPLUS TRANSFECTION SA A I A A A II II II II II II 10/15/2007 10/17/2007 10/15/2007 9/3/2007 9/3/2007 10/18/2007 II 10/12/2007 TAIZHOU CANDORLY SEA BIOCHEMICAL AND HEALTH PRODUCTS CO LTD EXCELLA GMBH CRYSTAL PHARMA SA SYNKEM SAS PT KIMIA FARMA PERSERO TBK PT KIMIA FARMA PERSERO TBK SANDOZ INDUSTRIAL PRODUCTS SPA I II II 10/15/2007 10/15/2007 DIVIS LABORATORIES LTD EURAND INC II 10/9/2007 WORLD JIANGSU INDUSTRY CO LTD III 9/25/2007 AARDEE EXTRUSIONS INDIA PV LTD A I II II II 10/3/2007 10/12/2007 10/12/2007 A II II 10/17/2007 9/24/2007 STATUS Type SUBMIT DATE II 8/4/2007 HOLDER ZHEJIANG HISOAR PHARMACEUTICAL CO LTD JUBILANT LIFE SCIENCES LTD ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD SUN PHARMACEUTICAL INDUSTRIES LTD RANBAXY LABORATORIES LTD SCINOPHARM TAIWAN LTD SUBJECT CLINDAMYCIN PHOSPHATE AS MANUFACTURED IN ZHEJIANG, CHINA OXCARBAZEPINE CO-PRECIPITATE AS MANUFACTURED IN KARNATAKA, INDIA VALSARTAN DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG, CHINA MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN PUNJAB, INDIA

4Q2012

DOCETAXEL TRIHYDRATE DRUG SUBSTANCE AS MANUFACTURED IN TAINAN, TAIWAN R.O.C. ALUMINIUM COLLAPSIBLE TUBES FOR FILLING & PACKING OF PHARMACEUTICAL OINTMENTS, CREAMS AND GELS AS MANUFACTURED IN GUJARAT, INDIA BACITRACIN USP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN FUJIANG PROVINCE, CHINA TRIPEPTIDE, DRUG INTERMEDIATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA EUR-1057 EXTENDED-RELEASE DOSAGE FORMS AS MANUFACTURED IN VANDALIA, OH DIDANOSINE EUR.PH NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA MYCOPHENOLATE MOFETIL (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY MIFEPRISTONE, MICRONIZED AS MANUFACTURED IN VALLADOLID, SPAIN CHOLINE FENOFIBRATE DRUG SUBSTANCE AS MANUFACTURED IN CHENOVE, FRANCE QUININE SULFATE AS MANUFACTURED IN WEST JAVA, INDONESIA QUININE HYDROCHLORIDE AS MANUFACTURED IN WEST JAVA, INDONESIA PRAVASTATIN T-BA, DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN TRENTO, ITALY 127A55 N&A CHERRY TYPE FLAVOR AS MANUFACTURED IN NORTH AURORA, IL 134A46 N&A CINNAMON FLAVOR AS MANUFACTURED IN NORTH AURORA, IL F94249 PEPPERMINT FLAVOR AS MANUFACTURED IN MILFORD, OH STERILE OXACILLIN SODIUM, BUFFERED AS MANUFACTURED IN TYROL, AUSTRIA IN VIVO-JETPEI(TM), NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN FREIBURG IM BREISGAU, FEDERAL REPUBLIC OF GERMANY BUPIVACAINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA LUDIFLASH(R) AS MANUFACTURED BY BASF AKTIENGESELLSCHAFT IN LUDWIGSHAFEN, GERMANY AND IPC PROCESS-CENTER GMBH & CO. KG IN DRESDEN, GERMANY FOR BASF AKTIENGESELLSCHAFT DOCETAXEL ANHYDROUS, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, CHINA FOR POLYMED THERAPEUTICS INC TADALAFIL AS MANUFACTURED IN MAHARASHTRA, INDIA VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

POLYVINYL CHLORIDE (PVC) RAW MATERIAL GRADE REON 60GER01 AS MANUFACTURED IN GUJARAT, INDIA

Page 630

4Q2012EXCEL DMF# 20966 A 20967 20968 20969 A 20970 20971 A 20972 A 20973 A 20974 A 20975 C 20976 A 20977 A 20978 20979 C 20980 A 20981 20982 20983 20984 20985 A 20986 20987 A 20988 A 20989 20990 20991 20992 A 20993 A II 11/2/2007 EXCELLA GMBH A C I II II III II 10/23/2007 10/22/2007 10/31/2007 10/31/2007 JUBILANT LIFE SCIENCES LTD JUBILANT LIFE SCIENCES LTD RICON COLORS INC PCI SYNTHESIS II 10/31/2007 NOVARTIS PHARMACEUTICALS CORP A IV II 10/22/2007 10/31/2007 LIPOID GMBH NEKTAR THERAPEUTICS A A A A II II II II II 10/22/2007 10/29/2007 10/25/2007 10/30/2007 10/31/2007 CAMBREX PROFARMACO MILANO SRL DR REDDYS LABORATORIES LTD DIVIS LABORATORIES LTD SANOFI CHIMIE FRESENIUS KABI ANTI INFECTIVES SRL QUETIAPINE FUMARATE AS MANUFACTURED IN MILAN, ITALY II 10/26/2007 LIFECORE BIOMEDICAL A III II 10/29/2007 10/29/2007 SUD CHEMIE PERFORMANCE PACKAGING TEVA PHARMACEUTICAL INDUSTRIES LTD MULTI LAYER BOTTLES AS MANUFACTURED IN NEW MILFORD, CT II 10/22/2007 INDENA SPA PACLITAXEL (ESUB) AS MANUFACTURED IN SETTALA, ITALY II 10/26/2007 II 10/26/2007 NORAMCO INC III 9/27/2007 HPT HOCHWERTIGE PHARMATECHNIK GMBH CO KG II 10/25/2007 III 9/25/2007 A II II 10/24/2007 10/25/2007 TRIFARMA SPA NANYANG PUKANG PHARMACEUTICAL CO LTD JITSAN ENTERPRISES I N II 12/13/2007 II 11/7/2007 CIPLA LTD NOT AN ASSIGNED NUMBER CIPLA LTD MOMETASONE FUROATE MONOHYDRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA FOSPHENYTOIN SODIUM AS MANUFACTURED IN MILAN, ITALY CLINDAMYCIN HYDROCHLORIDE AS MANUFACTURED IN HENAN, CHINA STATUS Type SUBMIT DATE III 10/19/2007 HOLDER RELIANCE INDUSTRIES LTD SUBJECT

4Q2012

POLYVINYL CHLORIDE (PVC) RAW MATERIAL GRADE REON 57GER01 AS MANUFACTURED IN GUJARAT, INDIA LOSARTAN POTASSIUM USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA

PLASTIC BOTTLE & CONTAINERS, PLUG, NOZZLE & DROPPERS, PILFER PROOF CAP & CHILD RESISTANCE CAP, MEASURE CUP & SPOONS, APPLICATORS & PESSARI APPLICATORS MANUFACTURED IN DAMAN, INDIA

HEBEI HUARONG PHARMACEUTICAL CO LTD CYANOCOBALAMIN AS MANUFACTURED IN HEBEI, CHINA ROUND TABLET JAR LINE WITH 2-PART TAMPER-EVIDENT CLOSURE, CHILD-RESISTANT, SENIOR-FRIENDLY WITH AND WITHOUT DRYING AGENT AS MANUFACTURED IN NEUHAUS A. RWG, GERMANY

OXYCODONE HYDROCHLORIDE AS MANUFACTURED IN ATHENS, GA AND WILMINGTON, DE PHARMACEUTICAL WORKS POLPHARMA SA PENTOXIFYLLINE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND

GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN NETANYA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD ANIMAL COMPONENT FREE SODIUM HYALURONATE AS MANUFACTURED IN CHASKA, MN

VALACYCLOVIR HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA QUETIAPINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ZOLPIDEM TARTRATE AS MANUFACTURED IN SISTERON, FRANCE BUFFERED CEFTAZIDIME PENTAHYDRATE, STERILE AS MANUFACTURED IN ROVIGO, ITALY LIPOID PE 18:0/18.0-PEG 2000 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY AMIKACIN PULMONARY DELIVERY SYSTEM AS MANUFACTURED IN GALWAY, IRELAND AND CARLOS, CA FOR NEKTAR THERAPEUTICS PULMONARY DRUG DELIVERY SYSTEM (PDDS) CLINICAL AS MANUFACTURED IN GALWAY, IRELAND AND SAN CARLOS, CA FOR NEKTAR THERAPEUTICS PANTOPRAZOLE SODIUM AS MANUFACTURED IN KARNATAKA, INDIA OLANZAPINE FORM-I AS MANUFACTURED IN KARNATAKA, INDIA CPP-R4261-1 FDA RED AS MANUFACTURED IN WEST CHICAGO, IL PCI-105551, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN NEWBURYPORT, MASSACHUSETTS EPINASTINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY

Page 631

4Q2012EXCEL DMF# 20994 20995 20996 20997 20998 A 20999 I 21000 A 21001 A 21002 21003 21004 A 21005 21006 C 21007 A 21008 21009 21010 21011 21012 A 21013 21014 A 21015 21016 21017 I I III III III 10/30/2007 10/30/2007 10/26/2007 RICON COLORS INC RICON COLORS INC DANAPAK FLEXIBLES AS I II IV 10/29/2007 11/2/2007 SAI ADVANTIUM PHARMA LTD DMV FONTERRA EXCIPIENTS GMBH CO KG A A A A II II II II II 12/3/2007 12/14/2007 10/26/2007 10/31/2007 10/29/2007 IPCA LABORATORIES LTD IPCA LABORATORIES LTD WOCKHARDT LTD WOCKHARDT LTD AUROBINDO PHARMA LTD II 4/17/2008 IPCA LABORATORIES LTD A II II 11/2/2007 11/2/2007 DR REDDYS LABORATORIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD A A II II II 11/2/2007 10/31/2007 10/26/2007 II 10/1/2007 ZHEJIANG HISOAR PHARMACEUTICAL CO LTD CSPC INNOVATION PHARM CO LTD GRANULES INDIA LTD SAVIOR LIFETEC CORP TAINAN BRANCH ATOVAQUONE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA CAFFEINE AS MANUFACTURED IN HEBEI, CHINA V 11/12/2007 II 10/1/2007 ZHEJIANG HISOAR PHARMACEUTICAL CO LTD CHUANNAN BRANCH AMGEN INC STATUS Type SUBMIT DATE A A A A II II II II II 10/22/2007 11/2/2007 10/30/2007 11/30/2007 10/31/2007 HOLDER HUAIAN MDC PHARMACEUTICAL CO LTD MALLINCKRODT INC MSN LABORATORIES LTD IPCA LABORATORIES LTD GRANULES INDIA LTD SUBJECT

4Q2012

HEPARIN SODIUM (CRUDE) AS MANUFACTURED IN JIANGSU PROVINCE, CHINA COCAINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN ST. LOUIS, MISSOURI DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CETIRIZINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA COMPRESSO GGF95SA (DIRECTLY COMPRESSIBLE GRANULES OF GUAIFENESIN 95%) AS MANUFACTURED IN ANDHRA PRADESH, INDIA REPAGLINIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA AML ASEPTIC PROCESSING WAREHOUSING AND LABORATORIES (ESUB) LOCATED IN JUNCOS, PUERTO RICO FOR AMGEN INC

CHLORPHENIRAMINE MALEATE USP AS MANUFACTURED IN HYDERABAD, INDIA IMIPENEM AND CILASTATIN SODIUM FOR INJECTION (STERILE BULK) AS MANUFACTURED IN TAINAN COUNTY, TAIWAN R.O.C. LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA IMATINIB MESYLATE AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO AND RHO, ITALY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD. PAROXETINE HYDROCHLORIDE (ESUB), AS MANUFACTURED IN MADHYA PRADESH, INDIA ALENDRONATE SODIUM USP (ESUB) MANUFACTURED IN MADHYA PRADESH, INDIA QUETIAPINE HEMIFUMARATE (ESUB)AS MANUFACTURED IN MADHYA PRADESH, INDIA VALACYCLOVIR HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA ZOLEDRONIC ACID MONOHYDRATE AS MANUFACTURED IN GUJARAT, INDIA Ziprasidone Hydrochloride USP (Non-Sterile Drug Substance) as manufactured in Andhra Pradesh, India ISRADIPINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA INHALATION GRADE LACTOSE(IGL) AS MANUFACTURED IN TARANAKI, NEW ZEALAND FOR DMV FONTERRA EXCIPIENTS GMBH CO KG FDA BLUE CPP-BL5963-1 AS MANUFACTURED IN WEST CHICAGO, IL FDA DK. BLUE CPP-BL5962-1 AS MANUFACTURED IN WEST CHICAGO, IL SURLYN KISI (PRODUCT CODE: 04-413-04-0-00035-XX), COMPOSITION: PAPER 50,0 G/M2/ADHESIVE 3,0 G/M2/PET 23,0 LM/POLYMER 10 G/M2/AL 12.0 LM/ETHYLENCOPOLYMER 30 G/M2 AS MANUFACTURED IN SLAGELSE AND HORSENS, DENMARK DONEPEZIL HYDROCHLORIDE (FORM-1) AS MANUFACTURED IN ANDHRA PRADESH, INDIA DONEPEZIL HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN GUJARAT, INDIA MANUFACTURING FACILITY IN ROME, ITALY CHILD RESISTANT CLOSURE X 24 MM AS MANUFACTURED IN CASTELGUELFO AND RIVANAZZANO, ITALY AND SAINT SULPICE, FRANCE

A 21018 C 21019 A 21020 21021 A A V III 11/8/2007 11/6/2007 INJECTALIA SRL BORMIOLI ROCCO SPA BU PLASTICS II 11/1/2007 TORRENT PHARMACEUTICALS LTD II 11/7/2007 HETERO DRUGS LTD

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4Q2012EXCEL DMF# 21022 A 21023 21024 A 21025 21026 I 21027 21028 I 21029 A 21030 I 21031 I 21032 21033 21034 21035 I 21036 21037 21038 A 21039 21040 A 21041 A 21042 21043 A 21044 21045 21046 21047 A 21048 A 21049 A III 11/27/2007 II 11/19/2007 A A A II II II II 11/9/2007 3/26/2008 11/15/2007 11/12/2007 YONSUNG FINE CHEMICALS CO LTD TOPCHEM PHARMACEUTICALS LTD MYLAN LABORATORIES LTD A II III 11/12/2007 11/7/2007 DR REDDYS LABORATORIES LTD AMPACET CORP II 11/16/2007 CHEMO IBERICA SA MADRID C II II 11/4/2007 11/15/2007 CTX LIFE SCIENCES PVT LTD POLYMED THERAPEUTICS INC HYDROCHLOROTHIAZIDE USP AS MANUFACTURED IN GUJARAT, INDIA A A II II II 11/13/2007 11/13/2007 11/7/2007 I A A IV II II II 11/7/2007 10/24/2007 10/30/2007 11/9/2007 IV 11/7/2007 IV 11/7/2007 IV 11/11/2007 A II IV 10/29/2007 11/7/2007 I II IV 11/7/2007 11/7/2007 DAINIPPON SUMITOMO PHARMA CO LTD KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE CADILA PHARMACEUTICALS LTD KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIO SCIENCE IND SWIFT LABORATORIES LTD CADILA PHARMACEUTICALS LTD PKUCARE CHONGQING DAXIN PHARMACEUTICAL CO LTD DR REDDYS LABORATORIES LTD EUTICALS SPA ZCL CHEMICALS LTD I IV III 11/7/2007 10/29/2007 KERRY BIO SCIENCE ACQUOS MASTERBATCH PTY LTD STATUS Type SUBMIT DATE III 11/8/2007 HOLDER BAYER MATERIALSCIENCE LLC SUBJECT

4Q2012

MAKROLON RESINS AS MANUFACTURED IN RAYONG, THAILAND FOR BAYER MATERIALSCIENCE LLC 5X00096 SHEFFIELD TABLETTING SYSTEM DTHV AS MANUFACTURED IN NORWICH, NY COLOR/ADDITIVE CONCENTRATES AS MANUFACTURED IN VICTORIA AND NSW, AUSTRALIA SMP-601 DRUG SUBSTANCE AS MANUFACTURED IN OITA, JAPAN 5X00086 SHEFFIELD COATING SYSTEM CLEAR S2 AS MANUFACTURED IN NORWICH, NY ONDANSETRON AS MANUFACTURED IN GUJARAT, INDIA 5X00083 SHEFFIELD COATING SYSTEM CLEAR AS MANUFACTURED IN NORWICH, NY 5X00090 SHEFFIELD TABLETTING SYSTEM ODT AS MANUFACTURED IN NORWICH, NY 5X00085 SHEFFIELD COATING SYSTEM CLEAR S AS MANUFACTURED IN NORWICH, NY 5X00084 SHEFFIELD COATING SYSTEM CLEAR K AS MANUFACTURED IN NORWICH, NY 5X00095 SHEFFIELD TABLETTING SYSTEM DTFD AS MANUFACTURED IN NORWICH, NY RISEDRONATE SODIUM AS MANUFACTURED IN PUNJAB, INDIA RABEPRAZOLE SODIUM (ESUB) AS MANUFACTURED IN GUAJARAT, INDIA AMIKACIN SULFATE (1:1.8) USP, NON-STERILE BULK DRUG SUBSTANCE, AS MANUFACTURED IN CHONGQING, CHINA LETROZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA SIROLIMUS AS MANUFACTURED IN ROZZANO, ITALY ALPHA-PHENYLPIPERIDINE-2-ACETIC ACID (KMN) AS MANUFACTURED IN GUJARAT, INDIA

DOCETAXEL TRIHYDRATE DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, CHINA FOR POLYMED THERAPEUTICS INC TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN MADRID, SPAIN FOR CHEMO IBERICA SA MADRID FAMOTIDINE (FORM-A) USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA AMPACET PRODUCT 11898-K LAMITE 98 AS MANUFACTURED IN RAYONG, THAILAND FOR AMPACET CORP LATANOPROST AS MANUFACTURED IN GYEONGGI-DO, KOREA MALATHION (ESUB) AS MANUFACTURED IN COUNTY SLIGO, IRELAND LOSARTAN POTASSIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

HUBEI BIOCAUSE PHARMACEUTICAL CO LTD FLUDARABINE PHOSPHATE DRUG SUBSTANCE AS MANUFACTURED IN HUBEI PROVINCE, CHINA DSM NUTRITIONAL PRODUCTS LTD CHOLECALCIFEROL(VITAMIN D3) AS MANUFACTURED IN BASEL, SWITZERLAND FOR DSM NUTRITIONAL PRODUCTS LTD 3M DRUG DELIVERY SYSTEMS EPDM ELASTOMERIC COMPONENTS FOR HFA INHALATION AEROSOL CONTAINER CLOSURE SYSTEM AS MANUFACTURED IN LEBANON, TN, SPARTANBURG, SC AND LANCASHIRE, U.K. FOR 3M DRUG DELIVERY SYSTEMS

Page 633

4Q2012EXCEL DMF# 21050 A 21051 21052 A 21053 21054 A 21055 21056 21057 A 21058 A 21059 21060 21061 21062 21063 A 21064 21065 21066 21067 21068 21069 21070 I 21071 21072 I 21073 21074 21075 21076 21077 21078 A 21079 21080 21081 21082 A N N A II 11/28/2007 II 11/28/2007 N N N N A II II 11/20/2007 11/28/2007 NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER AREVIPHARMA GMBH MIDWEST MEDICAL ISOTOPES LLC CYCLOTRON DIV EXCELLA GMBH NOT AN ASSIGNED NUMBER NOT AN ASSIGNED NUMBER SANDOZ PRIVATE LTD LANSOPRAZOLE AS MANUFACTURED IN RADEBEUL, GERMANY A II II 11/22/2007 11/9/2007 SIMAFEX SAS SIGMA ALDRICH MANUFACTURING LLC A A A A A A II IV II II II II III 11/27/2007 11/2/2007 11/13/2007 11/9/2007 11/25/2007 11/26/2007 11/13/2007 HARMAN FINOCHEM LTD CRODA INC JUBILANT LIFE SCIENCES LTD SIGMA ALDRICH MANUFACTURING LLC DIVIS LABORATORIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD AMPACET CORP A C A A II II II II III 11/15/2007 11/12/2007 11/23/2007 11/19/2007 11/20/2007 CENTAUR CHEMICALS PRIVATE LTD SIEGFRIED LTD SAVIOR LIFETEC CORP SUN PHARMACEUTICAL INDUSTRIES LTD NYPRO INC III 11/5/2007 A A III III II 10/25/2007 10/25/2007 11/19/2007 ESSEL PROPACK LTD ESSEL PROPACK LTD BOEHRINGER INGELHEIM AUSTRIA GMBH BIA PACKAGING INDIA PVT LTD PLASTIC TUBES AS MANUFACTURED IN MAHARASHTRA, INDIA LAMINATED TUBES AS MANUFACTURED IN MAHARASHTRA, INDIA RTNF-ALPHA DRUG SUBSTANCE AS MANUFACTURED IN VIENNA, AUSTRIA PRINTED PLASTIC FILM/ALUMINIUM FOIL BASE LAMINATE & POUCHES AS MANUFACTURED IN PONDICHERRY, INDIA ZOPICLONE AS MANUFACTURED IN MAHARASHTRA, INDIA A III II 11/5/2007 11/20/2007 PACKAGING INDIA PVT LTD CRYSTAL PHARMA SA I II III 11/6/2007 11/5/2007 YANGZHOU PHARMACEUTICAL CO LTD SILGAN WHITE CAP AMERICAS STATUS Type SUBMIT DATE II 11/9/2007 HOLDER SIGMA ALDRICH MANUFACTURING LLC SUBJECT

4Q2012

STEMLINE(TM) MESENCHYMAL STEM CELL EXPANSION MEDIUM AS MANUFACTURED IN ST. LOUIS, MO FELODIPINE USP AS MANUFACTURED IN JIANGSU PROVINCE, CHINA 18PPR ALUMINUM PILFERPROOF ROLL-ON CLOSURE AS MANUFACTURED IN RICHMOND, IN ALU - ALU COLD FOIL LAMINATES AS MANUFACTURED IN PONDICHERRY, INDIA FLUDROCORTISONE ACETATE, MICRONIZED AS MANUFACTURED IN VALLADOLID, SPAIN

BUPRENORPHINE HYDROCHLORIDE AS MANUFACTURED IN ZOFINGEN, SWITZERLAND MEROPENEM USP AS MANUFACTURED IN MIAO-LI COUNTY, TAIWAN R.O.C. CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA ADVAIR. HFA 120 DOSE 8ML METERED-DOSE INHALER COUNTER ACTUATOR/STRAPCAP AS MANUFACTURED IN ARDEN, NC FOR NYPRO INC CARISOPRODOL USP AS MANUFACTURED IN MAHARASHTRA, INDIA SUPER REFINED TWEEN 80 LLQ-(MH) AS MANUFACTURED IN MILL HALL PA TERAZOSIN HYDROCHLORIDE AS MANUFACTURED IN KARNATAKA, INDIA HEMOCYANIN FROM KEYHOLE LIMPET AS MANUFACTURED IN ST. LOUIS, MO TOPIRAMATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CANDESARTAN CILEXETIL AS MANUFACTURED IN BEER SHEVA, ISRAEL AMPACET 112109 WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; DERIDDER, LA CYCLAM AS MANUFACTURED IN MARANS, FRANCE STEMLINE(TM) DENDRITIC CELL MATURATION MEDIUM AS MANUFACTURED IN ST. LOUIS, MO

3'-DEOXY-3'-[18F]FLUOROTHYMIDINE AS MANUFACTURED IN OKLAHOMA CITY, OK MYCOPHENOLATE MOFETIL SIEVED (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY

PRAMIPEXOLE DIHYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA

Page 634

4Q2012EXCEL DMF# 21083 C 21084 A 21085 21086 21087 21088 I 21089 21090 21091 21092 21093 21094 A 21095 A 21096 A 21097 21098 A 21099 21100 21101 21102 A 21103 A 21104 21105 21106 A 21107 21108 A 21109 I 21110 21111 A A II II 12/6/2007 12/6/2007 GLOCHEM INDUSTRIES LTD MINRAD INC III 12/4/2007 MEDISIZE CORP I IV III 12/4/2007 11/26/2007 A A II II II 11/29/2007 11/28/2007 11/3/2007 II 11/30/2007 A A I II II II II 12/3/2007 12/3/2007 12/3/2007 11/28/2007 MYLAN LABORATORIES LTD RANBAXY LABORATORIES LTD RANBAXY LABORATORIES LTD JIANGSU ZW PHARMACEUTICALS CO LTD I II II 12/5/2007 12/3/2007 INDOCO REMEDIES LTD RANBAXY LABORATORIES LTD II 11/23/2007 AUROBINDO PHARMA LTD II 11/30/2007 APOTEX PHARMACHEM INDIA PVT LTD A I A A A II II II II II III 11/16/2007 11/26/2007 11/21/2007 12/3/2007 11/20/2007 11/28/2007 HUAYI ISOTOPE CO CORDEN PHARMACHEM TRIFARMA SPA TTY BIOPHARM CO LTD NISSAN CHEMICAL INDUSTRIES LTD BASELL POLYOLEFINE ITALIA SRL N A N II 11/15/2007 III 11/12/2007 NOT AN ASSIGNED NUMBER PARKER HANNIFIN TECHSEAL DIV NOT AN ASSIGNED NUMBER HANDE PHARMA DEVELOPMENT LTD EPDM ELASTOMERS AS MANUFACTURED IN SPARTANBURG, SC II 1/23/2008 STATUS Type SUBMIT DATE II 10/18/2007 HOLDER SUZHOU NUMBER 4 PHARMACUTICAL FACTORY JANSSEN PHARMACEUTICA NV SUBJECT

4Q2012

CLINDAMYCIN HYDROCHLORIDE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA TAPENTADOL HYDROCHLORIDE (R331333) DRUG SUBSTANCE (ESUB) AS MANUFACTURED BY JANSSEN PHARMACEUTICAL N.V. IN GEEL, BELGIUM; NORAMCO INC IN ATHENS, GA FOR JANSSEN PHARMACEUTICAL N.V.

GALANTHAMINE HYDROBROMIDE (NON-STERILE BULK FORM) AS MANUFACTURED IN SHANGHAI CITY, CHINA FOR HANDE PHARMA DEVELOPMENT LTD MANNOSE TRIFLATEAS MANUFACTURED IN JIANGSU PROVINCE, CHINA BENZPHETAMINE HYDROCHLORIDE AS MANUFACTURED IN CORK, IRELAND TESTOSTERONE CYPIONATE USP AS MANUFACTURED IN MILAN, ITALY ARSENIC TRIOXIDE AS MANUFACTURED IN TAOYUAN COUNTY, TAIWAN R.O.C. PAROGRELIL (NM-702) AS MANUFACTURED IN SANYOONODA YAMAGUCHI, JAPAN PURELLPE 3020 H AS MANUFACTURED IN WESSELING, GERMANY FOR BASELL POLYOLEFINE ITALIA SRL PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN KARNATAKA, INDIA FOR APOTEX PHARMACHEM INC TENOFOVIRDISOPROXIL FUMARATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA METFORMIN HYDROCHLORIDE USP, AS MAUFACTURED IN RAIGAD DISTRICT, INDIA TENOFOVIR DISOPROXIL FUMARATE DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA ZOLEDRONIC ACID AS MANUFACTURED IN ANDHRA PRADESH, INDIA OMEPRAZOLE MAGNESIUM DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA LOPINAVIR DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA

SULINDAC USP BP-EP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA UNION QUIMICO FARMACEUTICA SA UQUIFA BICALUTAMIDE AS MANUFACTURED IN BARCELONA, SPAIN SA SHASUN PHARMACEUTICALS LTD SEVELAMER HYDROCHLORIDE AS MANUFACTURED IN CUDDALORE, INDIA CAMBREX PROFARMACO MILANO SRL ACTAVIS PHARMA MANUFACTURING PRIVATE LTD FONA INTERNATIONAL INC AMPACET CORP LAMOTRIGINE AS MANUFACTURED IN MILAN, ITALY NISOLDIPINE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN TAMIL NADU, INDIA 862.536 LEMON FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL AMPACET PRODUCT 40604 SLIP BOPP MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; DERIDDER, LA STANDARD CFC ACTUATOR AS MANUFACTURED IN TYNE AND WEAR, UNITED KINGDOM FOR MEDIFIQ HEALTHCARE CORP LEVO CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA TORRANE(TM), DESFLURANE USP DRUG SUBSTANCE AS MANUFACTURED IN BETHLEHEM, PA

Page 635

4Q2012EXCEL DMF# 21112 A 21113 A 21114 21115 A 21116 I 21117 21118 A 21119 21120 A 21121 A 21122 21123 21124 A 21125 A 21126 21127 I 21128 I 21129 21130 21131 21132 A 21133 21134 21135 21136 21137 21138 A 21139 21140 21141 A A A II II II 12/14/2007 12/17/2007 12/11/2007 A A A A I II II III III III II 12/11/2007 11/15/2007 12/14/2007 12/14/2007 12/12/2007 12/12/2007 CADILA PHARMACEUTICALS LTD ALEMBIC PHARMACEUTICALS LTD POLYONE CORP POLYONE CORP BASELL USA INC SHANDONG NEW TIME PHARMACEUTICAL CO LTD SANDOZ GMBH LIST BIOLOGICAL LABORATORIES INC XELLIA PHARMACEUTICALS APS DESLORATADINE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA VALSARTAN USP AS MANUFACTURED IN GUJARAT, INDIA CC10100935WE 1585C ORANGE PE AS MANUFACTURED IN ELK GROVE, IL CC10100934WE 281C BLUE PE AS MANUFACTURED IN ELK GROVE VILLAGE, IL SOFTEL C102M AS MANUFACTURED IN MANTOVA, ITALY FOR BASELL USA INC A I A II II II II 11/18/2007 12/7/2007 12/5/2007 12/11/2007 ANUH PHARMA LTD ROTEM INDUSTRIES LTD FINE CHEMICALS CORP PTY LTD NEULAND LABORATORIES LTD II 12/10/2007 SAFC INC A II III 12/12/2007 10/16/2007 CHEMPACIFIC CORP CHROMA CORP II 12/14/2007 DR REDDYS LABORATORIES LTD I A II II III 11/26/2007 12/11/2007 12/12/2007 ALEMBIC PHARMACEUTICALS LTD NEULAND LABORATORIES LTD RENOLIT NEDERLAND BV II 12/6/2007 AUROBINDO PHARMA LTD A III II 1/29/2008 12/11/2007 A II II 11/30/2007 11/30/2007 MALLINCKRODT INC II 12/4/2007 PALL BIOSEPRA DIV PALL FRANCE SA A III II 1/29/2008 2/6/2008 RELIANCE INDUSTRIES LTD WUHAN WUYAO PHARMACEUTICAL CO LTD II 12/3/2007 ZACH SYSTEM SA STATUS Type SUBMIT DATE III 11/21/2007 HOLDER POLYONE CORP SUBJECT

4Q2012

CC10066777BG AS MANUFACTURED IN SAINT QUEN LAUMONE, FRANCE FOR POLYONE CORP METHOXY-C15-WITTIG SALT (TGN05), INTERMEDIATE FOR ACITRETIN API AS MANUFACTURED IN AVRILLE, FRANCE RELENE M60075, POLYETHYLENE (PE) AS MANUFACTURED IN GUJARAT, INDIA HYDROXYCHLOROQUINE SULFATE USP, NON-STERILE, BULK DRUG (ESUB) AS MANUFACTURED IN WUHAN, CHINA BIOSEPRA SP SPHERODEX M SPEC IGGH AS MANUFACTURED IN CERGY SAINT CHRISTOPHE, FRANCE Codeine Sulfate USP Powder (ESUB) as manufactured in St. Louis, MO

ZHEJIANG HISUN PHARMACEUTICAL CO LTD METHOTREXATE USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA RELIANCE INDUSTRIES LTD RELENE E52009 POLYETHYLENE (PE) AS MANUFACTURED IN GUJARAT, INDIA BIOSYN CORP SELENASE SOLUTION FOR INJECTION AND SELENASE ORAL SOLUTION DRUG PRODUCTS IN WASSSERBURG, GERMANY FOR BIOSYN CORPORATION RISEDRONATE SODIUM HEMIPENTAHYDRATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA LEVETIRACETAM AS MANUFACTURED IN GUJARAT, INDIA PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA SOLMED MATERIALS FOR BIOTECHNOLOGY AND LIFE SCIENCES APPLICATIONS AS MANUFACTURED IN MA ENKHUIZEN, THE NETHERLANDS ATORVASTATIN CALCIUM (BHA PREMIX) AS MANUFACUTRED IN ANDHRA PRADESH, INDIA BUSULFAN (CHP022) DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE, MD PC501017 33/1 DARK BLUE COLOR CONCENTRATE AS MANUFACURED IN MCHENRY, ILLINOIS CAMPTOTHECIN-20(S)-O-PROPIONATE HYDRATE AS MANUFACTURED IN MADISON, WI U.S.A. ERYTHROMYCIN OXIME AS MANUFACTURED IN MAHARASHTRA, INDIA MANNOSE TRIFLATE AS MANUFACTURED IN NES-ZIONA, ISRAEL FCC - 7250 AS MANUFACTURED IN CAPE TOWN, SOUTH AFRICA DONEPEZIL HYDROCHLORIDE (FORM-1) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

7-ADCA (INTERMEDIATE) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA CEFEPIME, UNSTERILE AS MANUFACTURED IN KUNDL, AUSTRIA BOTULINUMTOXIN TYPE A PURE NEUROTOXIN AS MANUFACTURED IN CAMPBELL, CA MOMETASONE FUROATE USP, NON-STERILE BULK AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA FOR XELLIA PHARMACEUTICALS APS

Page 636

4Q2012EXCEL DMF# 21142 21143 21144 21145 21146 I 21147 A 21148 21149 A 21150 A 21151 I 21152 21153 A 21154 21155 21156 21157 21158 A 21159 21160 21161 A 21162 A 21163 A 21164 21165 A 21166 21167 21168 A 21169 A 21170 A 21171 I II 10/10/2007 INTERPHARMA PRAHA A S III 11/16/2007 SAGAR RUBBER PRODUCTS PVT LTD II 12/19/2007 A A II III II 11/29/2007 12/21/2007 12/14/2007 CADILA PHARMACEUTICALS LTD MITSUI CHEMICALS AMERICA INC TIANJIN GENCOM PHARMACEUTICAL CO LTD CHEMO IBERICA SA MADRID A II II 12/17/2007 12/19/2007 NATCO PHARMA LTD MYLAN LABORATORIES LTD II 12/17/2007 GILEAD SCIENCES INC III 11/16/2007 A A II III III 11/26/2007 12/18/2007 12/20/2007 PROCOS SPA ESS DEE ALUMINIUM LTD MULTISORB TECHNOLOGIES INTERNATIONAL SAGAR RUBBER PRODUCTS PVT LTD A A N A II II 12/17/2007 12/18/2007 II II 12/13/2007 12/6/2007 CADILA PHARMACEUTICALS LTD AREVIPHARMA GMBH NOT AN ASSIGNED NUMBER POLI INDUSTRIA CHIMICA SPA NORAMCO INC S(+)MECAMYLAMINE HYDROCHLORIDEAS MANUFACTURED IN MILAN, ITALY A II II 12/8/2007 12/17/2007 CADILA PHARMACEUTICALS LTD NOF CORP II 12/12/2007 ORPEGEN PHARMA II 12/17/2007 SANDOZ INDUSTRIAL PRODUCTS GMBH A II II 12/18/2007 12/18/2007 GEDEON RICHTER PLC II 12/17/2007 DR REDDYS LABORATORIES LTD STATUS Type SUBMIT DATE A A A I II II II II II 11/28/2007 12/26/2007 6/20/2007 12/27/2007 12/27/2007 HOLDER HUAYI ISOTOPE CO RANBAXY LABORATORIES LTD SANOFI AVENTIS CHIMIE RANBAXY LABORATORIES LTD RANBAXY LABORATORIES LTD SUBJECT CRYPTAND 222 AS MANUFACTURED IN JIANGSU PROVINCE, CHINA LANSOPRAZOLE USP AS MANUFACTURED IN PUNJAB INDIA NALBUPHINE HYDROCHLORIDE AS MANUFACTURED IN ARAMON, FRANCE RITONAVIR AS MANUFACTURED IN HARYANA INDIA

4Q2012

SODIUM CARBONATE ANHYDROUS USNF (STERILE) AS MANUFACTURED IN MADHYA PRADESH INDIA ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA CDB-4124 AS MANUFACTURED IN DOROG, HUNGARY

PHARMACEUTICAL WORKS POLPHARMA SA REPAGLINIDE AS MANUFACTURED IN STAROGARD GDANSKI POLAND CEFEPIME/L-ARGININE STERILE MIXTURE AS MANUFACTURED IN FRANKFURT, GERMANY TS9708 (GKL02 COMBINATORIAL THYMUS TETRAPEPTIDE LIBRARY) AS MANUFACTURED IN HEIDELBERG, GERMANY Nebivolol Hydrochloride (ESUB) as manufactured in Gujarat, INDIA 4-NITROPHENOXY CARBONYL POLYOXYETHYLENE MW 10000 AS MANUFACTURED IN KANAGAWA, JAPAN SILDENAFIL CITRATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA METOPROLOL SUCCINATE AS MANUFACTURED IN RADEBEUL, GERMANY

HYDROCODONE BITARTRATE AS MANUFACTURED IN ATHENS GA 30601-1645 & WILMINGTONDELAWARE 19801-4417 OXO ACID DIPA SALT AS MANUFACTURED IN CAMERI (NO) ITALY PRIMARY PACKAGING MATERIAL AS MANUFACTURED IN KUNDAIM GOA INDIA STABILOX SOLID FORM OXYGEN ABSORBING PRODUCTS AS MANUFACTURED IN BUFFALO NY PACKING MATERIAL - ALLIED PRODUCTS FOR HEALTHCARE AS MANUFACTURED IN MEHSANA INDIA DAUNOXOME FOR INJECTION (DAUNORUBICIN CITRATE LIPOSOME) AS MANUFACTURED IN SAN DIMAS, CA TOLTERODINE TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CITALOPRAM HYDROBROMIDE USP (CSP) AS MANUFACTURED IN ANDHRA PRADESH, INDIA CARBETAPENTANE TANNATE AS MANUFACTURED IN GUJARAT, INDIA ADMER CP-31A AS MANUFACTURED IN LAPORTE, TEXAS GCLE AS MANUFACTURED IN TIANJIN, CHINA NEDOCROMIL DISODIUM AS MANUFACTURED IN MADRID, SPAIN FOR CHEMO IBERICA SA MADRID RUBBER CLOSURES (RUBBER STOPPERS) FOR INJECTABLES AS MANUFACTURED IN MEHSANA, INDIA TROSPIUM CHLORIDE AS MANUFACTURED IN PRAHA, CZECH REPUBLIC

Page 637

4Q2012EXCEL DMF# 21172 A 21173 A 21174 21175 21176 I 21177 21178 I 21179 21180 21181 21182 21183 21184 21185 A 21186 I 21187 21188 21189 21190 21191 21192 21193 21194 21195 A 21196 21197 21198 I 21199 21200 21201 21202 21203 21204 A A A A A A II II II II II II 12/21/2007 12/19/2007 12/20/2007 12/27/2007 12/17/2007 12/28/2007 APOTEX PHARMACHEM INC MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD SANDOZ INDUSTRIAL PRODUCTS GMBH MYLAN LABORATORIES LTD RANBAXY LABORATORIES LTD A A II II IV 12/20/2007 1/4/2008 12/28/2007 A A A A A A A I II II II II II II II II II 12/21/2007 12/12/2007 12/3/2007 11/28/2007 1/15/2008 12/20/2007 12/28/2007 12/24/2007 12/28/2007 III 12/26/2007 BAYER PLASTIK TUP AMBALAJ SAN VE TIC AS MYLAN LABORATORIES LTD PIRAMAL HEALTHCARE UK LTD GLAND PHARMA LTD CADILA PHARMACEUTICALS LTD FRESENIUS KABI ONCOLOGY LTD CADILA HEALTHCARE LTD UNICHEM LABORATORIES LTD RANBAXY LABORATORIES LTD ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD EXCELLA GMBH ZHUHAI UNITED LABORATORIES CO LTD 3V INC A A I A A A II II II II II II III 12/15/2007 1/3/2008 12/31/2007 12/21/2007 12/25/2007 12/21/2007 1/2/2008 AARTI INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD SUZHOU LIXIN PHARMACEUTICAL CO LTD TEVA GROUP SCINOPHARM TAIWAN LTD LEK PHARMACEUTICALS DD MULTISORB TECHNOLOGIES INC A II II 12/10/2007 1/3/2008 JUBILANT LIFE SCIENCES LTD CHR HANSEN INC I A II II II 12/17/2007 12/21/2007 12/21/2007 CHATHAM BIOTEC LTD SCINOPHARM TAIWAN LTD DR REDDYS LABORATORIES LTD II 12/20/2007 CRYSTAL PHARMA SAU STATUS Type SUBMIT DATE II 12/21/2007 HOLDER ITF CHEMICAL LTDA SUBJECT

4Q2012

SODIUM RISEDRONATE AMORPHOUS AS MANUFACTURED IN BAHIA, BRAZIL AND PATRICA, ITALY FOR ITF CHEMICAL LTDA TRIAMCINOLONE ACETONIDE STERILE MICRONIZED, USP AS MANUFACTURED IN BOECILLO, SPAIN SEMISYNTHETIC PACLITAXEL AS MANUFACTURED IN SHANGHAI, CHINA EXEMESTANE DRUG SUBSTANCE AS MANUFACTURED IN TAINAN, TAIWAN R.O.C. PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTUREDIN ANDHRA PRADESH, INDIA LOSARTAN POTASSIUM AS MANUFACTURED IN KARNATAKA, INDIA LACTOBACILLUS GG LGG GRADE PAB GIN #679554 AS MANUFACTURED IN ROSKILDE DENMARK IPRATROPIUM BROMIDE AS MANUFACTURED IN MAHARASHTRA INDIA PEMETREXED DIACID AS MANUFACTURED IN RHO ITALY HYDROCHLOROTHIAZIDE AS MANUFACTURED IN JIANGSU CHINA LETROZOLE AS MANUFACTURED IN LERMA MEXICO SN38 AS MANUFACTURED IN SHAN-HUA TAIWAN TOLTERODINE TARTRATE AS MANUFACTURED IN MENGES SLOVENIA STABILOX CANISTER OXYGEN ABSORGING PRODUCTS AS MANUFACTURED IN BUFFALO NY PACKAGING (TUBES) AS MANUFACTURED IN ISTANBUL TURKEY DESLORATADINE AS MANUFACTURED IN ANDHRA PRADESH INDIA MISOPROSTOL DISPERSION AS MANUFACTURED IN UK ATRACURIUM BESYLATE USP (ESUB) AS MANUFACTURED IN HYDERABAD INDIA ITOPRIDE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA LETROZOLE (ESUB) AS MANUFACTURED IN WEST BENGAL, INDIA RABEPRAZOLE SODIUM (AMORPHOUS) AS MANUFACTURED IN GUJARAT, INDIA ZOLPIDEM TARTRATE (ESUB) AS MANUFACTURED IN DHAR (M.P.), INDIA MEROPENEM TECHNICAL AS MANUFACTURED IN MADHYA PRADESH, INDIA VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA BUPIVACAINE HYDROCHLORIDE AS MANUFACTURED IN FEUCHT, GERMANY AMOXICILLIN (COMPACTED) AS MANUFACTURED IN ZHUHAI CHINA SYNTHALEN KP, SYNTHALEN LP, SYNTHALEN MP AS MANUFACTURED IN GEORGETOWN SC MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN ONTARIO CANADA ARMODAFINIL AS MANUFACTURED IN ANDHRA PRADESH INDIA LEVETIRACETAM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA CEFOTAXIME SODIUM, STERILE AS MANUFACTURED IN FRANKFURT, GERMANY RABEPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA PANTOPRAZOLE SODIUM SESQUIHYDRATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN PUNJAB, INDIA

Page 638

4Q2012EXCEL DMF# 21205 I 21206 21207 21208 21209 21210 21211 21212 A 21213 21214 21215 21216 21217 A 21218 21219 A 21220 A 21221 21222 A 21223 A 21224 A 21225 21226 21227 21228 A 21229 21230 21231 A 21232 A 21233 21234 A 21235 A II 1/16/2008 GLOCHEM INDUSTRIES LTD A II II 1/15/2008 1/15/2008 EVERLIGHT CHEMICAL INDUSTRIAL CORP APICORE LLC II 1/16/2008 DSM ANTI INFECTIVES BV A A II II II 1/11/2008 1/10/2008 1/16/2008 GLENMARK GENERICS LTD LUPIN LTD DSM ANTI INFECTIVES BV A A A IV III II II 1/4/2008 1/7/2008 1/11/2008 1/11/2008 COREL PHARMACHEM JAPAN VILENE CO LTD APOTEX PHARMACHEM INDIA PVT LTD SIGMA ALDRICH MANUFACTURING LLC II 1/17/2008 H LUNDBECK AS II 12/31/2007 A II II 12/7/2007 12/28/2007 JIANGSU EQUALCHEM CO LTD ZHEJIANG SUPOR PHARMACEUTICALS CO LTD AUROBINDO PHARMA LTD III 1/3/2008 CONSOLIDATED BOTTLE CORP A V V 12/18/2007 12/20/2007 LEK PHARMACEUTICALS DD ELI LILLY AND CO A A A A II II II II II 12/31/2007 1/4/2008 12/21/2007 1/2/2008 12/28/2007 WOCKHARDT LTD SUN PHARMACEUTICAL INDUSTRIES LTD MYLAN LABORATORIES LTD HALCYON LABS PRIVATE LTD SUN PHARMACEUTICAL INDUSTRIES LTD A A A A A A II II II II II II II 12/18/2007 1/3/2008 1/2/2008 1/7/2008 1/3/2008 12/31/2007 12/13/2007 MYLAN LABORATORIES LTD CADILA HEALTHCARE LTD TARO PHARMACEUTICAL INDUSTRIES LTD DR REDDYS LABORATORIES LTD LUPIN LTD WOCKHARDT LTD EVESTRA INC STATUS Type SUBMIT DATE II 12/28/2007 HOLDER RANBAXY LABORATORIES LTD SUBJECT

4Q2012

RABEPRAZOLE SODIUM (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN PUNJAB, INDIA LISINOPRIL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA QUETIAPINE FUMARATE AS MANUFACTURED IN GUJARAT, INDIA ADAPALENE MICRONIZED AS MANUFACTURED IN HAIFA BAY ISRAEL TADALAFIL AS MANUFACTURED IN ANDHRA PRADESH INDIA GLIPIZIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA NICARDIPINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA ESTRA-1,3,5((10)-TRIENE-3,11B-TRIOL, 3-ACETATE 11,17-DINITRATE (CDB-3701) AS MANUFACTURED IN SAN ANTONIO TX EPINEPHRINE USP AS MANUFACTURED IN GUJARAT, INDIA LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA DIDANOSINE USP as manufactured in Andhra Pradesh, INDIA CLOBETASOL USP AS MANUFACTURED IN GUJARAT, INDIA NALTREXONE HYDROCHLORIDE USP (DIHYDRATE FORM) AS MANUFACTURED IN GUJARAT, INDIA STERILE MANUFACTURING FACILITY IN LJUBLJANA, SLOVENIA PROCEDURES FOR STERILE OPERATIONS (ESUB) IN BUILDING 103, INDIANAPOLIS, INDIANA 60ML WHITE HDPE ROUND BOTTLE 38/400 (010897) AS MANUFACTURED IN ONTARIO, CANADA FOR CONSOLIDATED BOTTLE CORP TRICLOSAN (NON-STERILE BULK FORM) AS MANUFACTURED IN JIANGSU, CHINA BUPROPION HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA OMEPRAZOLE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA LU AA21004 HYDROBROMIDE (ESUB) AS MANUFACTURED IN NYKJOEBING SJ AND VALBY, DENMARK COLORCOAT, READY TO USE COATING MATERIAL AS MANUFACTURED IN KADI, INDIA MEDICAL BACKING NON-WOVEN PRODUCTS AS MANUFACTURED IN IBARAKI, JAPAN MYCOPHENOLATE MOFETIL EP AS MANUFACTURED IN BANGALORE, INDIA TRYPZEAN BOVINE, RECOMBINANT EXPRESSED IN CORN AS MANUFACTURED IN ST. LOUIS, MO TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT STATE, INDIA LAMIVUDINE AS MANUFACTURED IN MAHARASHTRA, INDIA MYCOPHENOLIC ACID TRIETHYLAMINE SALT AS MANUFACTURED IN STRANGNAS, SWEDEN FOR DSM ANTI-INFECTIVES BV MYCOPHENOLATE MOFETIL AS MANUFACTURED IN HARYANA, INDIA FOR DSM ANTIINFECTIVES BV ALPROSTADIL AS MANUFACTURED IN TAOYUAN HSIEN, TAIWAN Protriptyline Hydrochloride (ESUB) as manufactured by Tonira Pharma Limited in Gujarat, India for Apicore LLC CLOPIDOGREL BISULPHATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 639

4Q2012EXCEL DMF# 21236 A 21237 A 21238 A 21239 21240 A 21241 21242 I 21243 A 21244 A 21245 21246 21247 21248 A 21249 I 21250 21251 21252 A 21253 21254 A 21255 A 21256 A 21257 21258 21259 21260 21261 21262 A 21263 21264 C A II II 1/23/2008 1/23/2008 SYMBIOTEC PHARMALAB LTD TEVA PHARMACEUTICAL INDUSTRIES LTD A P A A C II II II IV 1/14/2008 1/11/2008 1/23/2008 1/22/2008 II 1/20/2006 II 1/16/2008 CHANGZHOU RUIMING PHARMACEUTICAL CO LTD FINETECH PHARMACEUTICAL LTD *** PENDING FILING REVIEW *** YONEZAWA HAMARI CHEMICALS CO LTD RIZHAO TOP SCIENCE BIO TECH CO LTD TEVA PHARMACEUTICAL INDUSTRIES LTD SYMRISE INC POLAPREZINC AS MANUFACTURED IN YAMAGATA, JAPAN II 1/16/2008 ALP PHARM BEIJING CO LTD A III II 1/22/2008 2/7/2008 CODING PRODUCTS IPCA LABORATORIES LTD I A II II III 1/22/2008 1/15/2008 1/18/2008 II 12/6/2007 ZHEJIANG HISOAR PHARMACEUTICAL CO LTD SMS PHARMACEUTICALS LTD RA CHEM PHARMA LTD INEOS SERVICES BELGIUM NV A A A II II II II 12/19/2007 1/10/2008 1/14/2008 1/10/2008 ASIAN HERBEX LTD SAI ADVANTIUM PHARMA LTD PROCOS SPA BENE PHARMACHEM GMBH AND CO KG II 1/9/2008 WORLD JIANGSU INDUSTRY CO LTD II 1/8/2008 WORLD JIANGSU INDUSTRY CO LTD P II 2/18/2008 *** PENDING FILING REVIEW *** IPCA LABORATORIES LTD A II III 1/15/2008 2/6/2008 II 1/31/2008 ORCHID CHEMICALS AND PHARMACEUTICALS LTD INDOCO REMEDIES LTD TRICORBRAUN II 1/11/2008 CHEMWERTH INC STATUS Type SUBMIT DATE III 1/10/2008 HOLDER AMPACET CORP SUBJECT

4Q2012

AMPACET 181908 AMBER POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; DERIDDER, LA MELPHALAN USP, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN FREIBURG, GERMANY FOR CHEMWERTH INC GEMIFLOXACIN MESYLATE (NON-STERILE BULK API) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ALLOPURINOL USP AS MANUFACTURED IN DISTRICT RAIGAS, INDIA MAGNESIUM SULFATE DESICCANT (ESUB) AS MANUFACTURED BY TOMITA PHARMACEUTICAL CO. LTD. IN TOKUSHIMA PREF, JAPAN FOR TRICORBRAUN CLOPIDOGREL BISULFATE (FORM 1) USP (PROCESS-II) (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA FUSIDIC ACID & SODIUM FUSIDATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN FUJIANG PROVINCE, CHINA POLYMYXIN B SULFATE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN FUJIANG PROVINCE, CHINA CURCUMIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA BENZINDENE TRIOL INTERMEDIATE AS MANUFACTURED IN KARNATAKA, INDIA FELBAMATE AS MANUFACTURED IN CAMERI, ITALY PENTOSAN POLYSULFATE SODIUM (PPS), NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN GERETSRIED, GERMANY TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, CHINA SILDENAFIL CITRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA METAXALONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA LOW DENSITY POLYETHYLENE GRADES ELTEX MED PH22D630, PH23T630, PH27D630 AND PH30D630 AS MANUFACTURED IN STATHELLE, NORWAY FOR INEOS SERVICES BELGIUM NV TTR-79160 (THERMAL TRANSFER RIBBON) AS MANUFACTURED IN KALKASKA, MI METOPROLOL TARTRATE (PROCESS-III) (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA PARICALCITOL USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN BEIJING, CHINA AMLODIPINE BESYLATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED INJIANGSU PROVINCE, CHINA TROVOPROST (TOS-00) AS MANUFACTURED IN NESHER, ISRAEL

CHONDROITIN SULFATE SODIUM AS MANUFACTURED IN SHANDONG PROVINCE, CHINA FLUOCINONIDE MICRONIZED (NEW PROCESS) AS MANUFACTURED IN RHO, ITALY 387897 NATURAL GRAPE FLAVOR WONF AS MANUFACTURED IN TETERBORO AND BRANCHBURG, NJ TRIAMCINOLONE ACETONIDE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA CINACALCET HYDROCHLORIDE AS MANUFACTURED IN BEER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD Page 640

4Q2012EXCEL DMF# 21265 21266 21267 21268 A 21269 21270 21271 21272 21273 A 21274 21275 21276 21277 C 21278 C 21279 A 21280 A 21281 A 21282 A 21283 A 21284 A 21285 21286 21287 21288 21289 A 21290 A 21291 21292 A 21293 21294 21295 A A A III II II 1/15/2008 2/1/2008 1/31/2008 ROLLPRINT PACKAGING PRODUCTS INC AARTI DRUGS LTD DR REDDYS LABORATORIES LTD A III III 1/25/2008 1/23/2008 FEDERAL PACKAGE NETWORK INC LG CHEM LTD III 1/9/2008 AMPACET CORP A A A A II II II II II 1/28/2008 1/28/2008 1/28/2008 1/29/2008 1/13/2008 II 1/15/2008 TAIZHOU HIGHSUN PHARMACEUTICAL CO LTD POSH CHEMICALS PRIVATE LTD POSH CHEMICALS PRIVATE LTD POSH CHEMICALS PRIVATE LTD ALKERMES GAINESVILLE LLC HASKELL PHARMACEUTICALS INC II 1/15/2008 TAI HENG INDUSTRY CO LTD II 1/18/2008 III 1/4/2008 II 1/22/2008 II 1/22/2008 II 1/22/2008 I I A II II II II 1/22/2008 1/22/2008 1/21/2008 1/22/2008 A I I I III II II II IV 1/10/2008 1/22/2008 1/22/2008 1/22/2008 1/14/2008 STATUS Type SUBMIT DATE I A I II IV II II 1/24/2008 1/18/2008 1/22/2008 12/5/2007 HOLDER DR REDDYS LABORATORIES LTD SEPPIC SA BENZOCHEM LIFESCIENCES PVT LTD ZHEJIANG CANDORLY PHARMACEUTICAL CO LTD FUTURA MEDICAL PRODUCTS P LTD BENZOCHEM LIFESCIENCES PVT LTD BENZOCHEM LIFESCIENCES PVT. LTD. BENZOCHEM LIFESCIENCES PVT LTD MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS BENZOCHEM LIFESCIENCES PVT LTD BENZOCHEM LIFESCIENCES PVT LTD MSN LABORATORIES LTD SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD AUSTAR HANSEN PACKAGE TECHNOLOGY LTD ALDRICH CHEMICAL CO ISOTEC FACILITY SUBJECT SIMVASTATIN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA SEPINEO P 600 AS MANUFACTURED IN CASTRES, FRANCE FOR SEPPIC SA MERCAPTOPURINE USP AS MANUFACTURED IN BOISAR, INDIA

4Q2012

2,3-DIDEHYDROGEN-2,3-DIDEOXY INOSINE SODIUM FOR DIDANOSINEINTERMEDIATE (D4I SODIUM) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA CONTAINER FOR PACKAGING HUMAN DRUGS AS MANUFACTURED IN KERALA, INDIA METHOTREXATE USP AS MANUFACTURED IN BOISAR, INDIA METOCLOPRAMIDE HYDROCHLORIDE USP AS MANUFACTURED IN BOISAR, INDIA IRINOTICAN HYDROCHLORIDE AS MANUFACTURED IN BOISAR, INDIA 709319 NATURAL ORANGE FLAVOR WONF AS MANUFACTURED IN CLARK, NJ GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN BOISAR, INDIA DOCETAXEL ANHYDROUS AS MANUFACTURED IN BOISAR, INDIA FINASTERIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA ZIDOVUDINE USP AS MANUFACTURED IN SHANGHAI, CHINA LAMIVUDINE AS MANUFACTURED IN SHANGHAI, CHINA STAVUDINE USP AS MANUFACTURED IN SHANGHAI, CHINA NIVERAPINE (ANHYDROUS) AS MANUFACTURED IN SHANGHAI, CHINA SPIKE PORT AND INJECTION PORT AS MANUFACTURED IN BEIJING, CHINA CHOLESTEROL-3,4-(13)C(2), FOR PHASE I CLINICAL STUDIES AS MANUFACTURED IN MIAMISBURG, OH CARBINOXAMINE MALEATE API USP AS MANUFACTURED IN JIANGSU, CHINA FOR TAI HENG INDUSTRY CO LTD VALACYCLOVIR HYDROCHLORIDE, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG, CHINA PHENAZOPYRIDINE HYDROCHLORIDE USP AS MANUFACTURED IN HYDERABAD, INDIA PHENAZOPYRIDINE DC LACTOSE AS MANUFACTURED IN HYDERABAD, INDIA PHENAZOPYRIDINE DC PVP AS MANUFACTURED IN HYDERABAD, INDIA ELN 154088 ( ESUB) AS MANUFACTURED IN GAINESVILLE, GA ISOLATION AND STORAGE OF PECAN SKIN AID AS MANUFACTURED IN BROOKSHIRE, TX 110042 BLUE WHITE POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; DERIDDER, LA NO. 500 CLASSIC PROPEL/REPEL STICK AS MANUFACTURED IN CHASKA, MN LDPE PRODUCTS INTENDED FOR USE IN DRUG PACKAGING APPLICATIONS AS MANUFACTURED IN SEOUL, KOREA RPP#26-1010 AS MANUFACTURED IN ADDISON, IL METFORMIN HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 641

4Q2012EXCEL DMF# 21296 21297 A 21298 21299 21300 21301 21302 21303 21304 21305 21306 21307 A 21308 21309 A 21310 21311 21312 A 21313 21314 I 21315 A 21316 21317 A 21318 A 21319 A 21320 21321 A 21322 A 21323 A 21324 A 21325 A II 2/6/2008 II 2/1/2008 II 2/7/2008 II 2/7/2008 A II III 2/4/2008 1/30/2008 II 2/5/2008 IV 2/5/2008 A III IV 11/22/2007 2/5/2008 III 1/30/2008 SCHOTT GLASS TECHNOLOGIES SUZHOU CO LTD REXAM PHARMA PACKAGING INDIA P LTD MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS FIDIA FARMACEUTICI SPA DIVISIONE SOLMAG HALCYON LABS PRIVATE LTD AMPACET CORP A II II 2/6/2008 2/6/2008 DR REDDYS LABORATORIES LTD TAIHO PHARMACEUTICAL CO LTD A A II II IV 2/5/2008 2/5/2008 2/5/2008 NATCO PHARMA LTD EVERLIGHT CHEMICAL INDUSTRIAL CORP FONA INTERNATIONAL INC A II II 2/5/2008 2/4/2008 A A A A A A A A A III III II II III II II III III II 1/28/2008 1/28/2008 1/24/2008 1/31/2008 1/15/2008 1/1/2008 1/30/2008 1/25/2008 1/25/2008 2/4/2008 TRI STATE DISTRIBUTION TRI STATE DISTRIBUTION SUN PHARMACEUTICAL INDUSTRIES LTD MSN PHARMACHEM PVT LTD CAPSEAL TEVA PHARMACEUTICAL INDUSTRIES LTD LUNDBECK PHARMACEUTICALS ITALY SPA BERRY PLASTICS CORP BERRY PLASTICS CORP DISHMAN PHARMACEUTICALS AND CHEMICALS LTD NATCO PHARMA LTD MSN LABORATORIES LTD STATUS Type SUBMIT DATE A III III 1/28/2008 1/28/2008 HOLDER TRI STATE DISTRIBUTION TRI STATE DISTRIBUTION SUBJECT

4Q2012

PLASTIC INJECTION BLOW MOLDED BOTTLES AS MANUFACTURED IN SPARTA, TN PLASTIC INJECTION STRETCH BLOW MOLDED BOTTLES AS MANUFACTURED IN SPARTA, TN PLASTIC INJECTION MOLDED BOTTLES AS MANUFACTURED IN SPARTA, TN PLASTIC INJECTION MOLDED CLOSURES AS MANUFACTURED IN SPARTA, TN FINASTERIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA CARBINOXAMINE MALEATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA ALUMINIUM SEALS AS MANUFACTURED IN NANI DAMAN, INDIA EPIRUBICIN HYDROCHLORIDE PRECIPITATED AS MANUFACTURED IN VERCELLI, ITALY ARGATROBAN AS MANUFACTURED IN PADOVA, ITALY BPC48-LS AS MNUFACTURED BY BERRY PLASTICS BPC48-WLS AS MANUFACTURED BY BERRY PLASTICS PRALIDOXIME CHLORIDE AS MANUFACTURED IN GUJARAT, INDIA ZOLMITRIPTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA CLOPIDOGREL BISULFATE USP (FORM-1) AS MANUFACTURED IN ANDHRA PRADESH, INDIA OMEPRAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA EPOPROSTENOL SODIUM AS MANUFACTURED IN TAOYUAN HSIEN, TAIWAN 906.264 VERY RASPBERRY (AN ARTIFICIAL FLAVOR) AS MANUFACTURED IN GENEVA, IL ZAFIRLUKAST (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA TAC-101 DRUG SUBSTANCE AS MANUFACTURED IN SANT CELONI BARCELONA, SPAIN FOR TAIHO PHARMACEUTICAL CO LTD PRIMARY PACKAGING MATERIAL (VIALS, AMPOULES) AS MANUFACTURED INJIANGSU PROVINCE, CHINA GNEX CONTAINER, CLOSURE SYSTEM AS MANUFACTURED IN BANGALORE, INDIA 700078 ARTIFICIAL CHERRY FLAVOR AS MANUFACTURED IN CLARK, NJ 700512 ARTIFICIAL CHERRY FLAVOR AS MANUFACTURED IN CLARK, NJ BENZPHETAMINE HYDROCHLORIDE AS MANUFACTURED IN GARBAGNATE MILANESE, ITALY BETAMETHASONE VALERATE USP AS MANUFACTURED IN GUJARAT, INDIA

AMPACET 110313-C WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; DERIDDER, LA CALYX CHEMICALS AND PHARMACEUTICALS ISONIAZID USP AS MANUFACTURED IN MAHARASHTRA, INDIA LTD PEPTISYNTHA SA OMIGANAN PENTAHYDROCHLORIDE BULK DRUG SUBSTANCE AS MANUFACTURED IN BRUSSELS, BELGIUM CHR HANSEN INC LACTOBACILLUS GG, LGG Grade PAb AS MANUFACTURED IN ROSKILDE AND HVIDOVRE, DENMARK FOR CHR HANSEN INC SIBRA PHARMACEUTICALS LTD AN ARCH ZIDOVUDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA ENTERPRISE

Page 642

4Q2012EXCEL DMF# 21326 21327 A 21328 A 21329 A 21330 A 21331 21332 21333 21334 21335 21336 21337 21338 21339 A 21340 21341 21342 A 21343 A 21344 21345 21346 A 21347 21348 A 21349 21350 21351 A 21352 A 21353 21354 A 21355 21356 A A II II 2/5/2008 2/5/2008 A II II 2/21/2008 4/2/2008 IV 2/15/2008 A A II III II 2/6/2008 2/20/2008 2/20/2008 A II II 2/1/2008 2/20/2008 CTX LIFE SCIENCES PVT LTD AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO SPA PCAS TAISEI KAKO CO LTD FUJI SILYSIA CHEMICAL LTD A A II II III 2/18/2008 2/18/2008 10/3/2007 II 1/31/2008 A A III II II 2/13/2008 9/3/2007 2/15/2008 REXAM HEALTHCARE OFFRANVILLE SAS GENESEN LABS LTD CHINA NATIONAL PHARMACEUTICAL FOREIGN TRADE CORP ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD DR REDDYS LABORATORIES LTD DR REDDYS LABORATORIES LTD SEWA MEDICALS LTD A A A A A A A A II II II II II II IV IV III 2/7/2008 2/12/2008 9/3/2007 2/12/2008 2/14/2008 2/12/2008 2/14/2008 2/14/2008 2/12/2008 WATSON PHARMA PRIVATE LTD DR REDDYS LABORATORIES LTD GENESEN LABS LTD AARTI INDUSTRIES LTD SYMED LABS LTD AARTI INDUSTRIES LTD FONA INTERNATIONAL INC FONA INTERNATIONAL INC CORMACK PACKAGING PTY LTD II 1/31/2008 WATSON PHARMA PRIVATE LTD II 1/31/2008 AUROBINDO PHARMA LTD III 2/5/2008 AVON AMPOULES PVT LTD STATUS Type SUBMIT DATE A II II 2/7/2008 2/11/2008 HOLDER TAI HENG INDUSTRY CO LTD TEVA PHARMACEUTICALS INDUSTRIES LTD SUBJECT GLYCOPYRROLATE USP AS MANUFACTURED IN SHANGHAI, CHINA

4Q2012

RALOXIFENE HYDROCHLORIDE BULK DRUG SUBSTANCE AS MANUFACTURED IN VERCELLI, ITALY FOR TEVA GROUP NEUTRAL GLASS AMPOULES AND TUBULAR VIALS AS MANUFACTURED INAHMEDABAD, INDIA CEFOXITIN SODIUM USP (STERILE BULK) AS MANUFACTURED IN ANDHRA PRADESH, INDIA NORTRIPTYLINE HYDROCHLORIDE USP AS MANUFACTURED IN AMBERNATH(EAST), INDIA ROPINIROLE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA TACROLIMUS PREMIX AS MANUFACTURED IN ANDHRA PRADESH, INDIA BICALUTAMIDE AS MANUFACTURED IN MUMBAI, INDIA MOMETASONE FUROATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA CARBINOXAMINE MALEATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA QUETIAPINE HEMIFUMARATE AS MANUFACTURED IN MAHARASHTRA, INDIA 895.096 NAT PINEAPPLE FLAVOR (WONF)AS MANUFACTURED IN GENEVA, IL 889. 244 PEACH FLAVOR, NATURAL (WONF)AS MANUFACTURED IN GENEVA, IL CORMACK TECR-TT (3-PIECE TAMPER EVIDENT CHILD RESISTANCE CLOSURE FOR TAMPER TEL NECK FINISH, SIZE 24 & 28MM) AS MANUFACTURED IN NEW SOUTH WALES, AUSTRALIA PP EYE-DROPPER RANGE AS MANUFACTURED INOFFRANVILLE, FRANCE DIVALPROEX SODIUM AS MANUFACTURED IN NAVI MUMBAI, INDIA RITALINIC ACID AS MANUFACTURED IN JIANGSU PROVINCE, CHINA FOR CHINA NATIONAL PHARMACEUTICAL FOREIGN TRADE CORP THIAPROLINE-M-AMINO BENZOIC ACID HYDROCHLORIDE (TPAB HYDROCHLORIDE) DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG, CHINA ZOLEDRONIC ACID MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA APREPITANT AS MANUFACTURED IN ANDHRA PRADESH, INDIA TYFILL STERILE & NON-STERILE GLASS PREFILLABLE SYRINGES AS MANUFACTURED IN PUNE, INDIA METOPROLOL TARTRATEUSP AS MANUFACTURED IN SURAT, INDIA ACAMPROSATE CALCIUM AS MANUFACTURED INAPRILIA, ITALY DORZOLAMIDE HYDROCHLORIDE AS MANUFACTURED IN TURKU, FINLAND FOR PCAS PLASTIC SYRINGES AS MANUFACTURED IN KANAGAWA, JAPAN

SYNTHETIC AMORPHOUS SILICA FOR CHROMATOGRAPHY PRODUCTS AS MANUFACTURED IN MIYAZAKI-KEN, JAPAN HENRY H OTTENS MANUFACTURING CO INC SPRAY DRIED ARTIFICIAL GRAPE FLAVOR #S-120 AS MANUFACTURED IN PHILADELPHIA, PA NORAMCO INC PURIFIED OXYCODONE BASE AS MANUFACTURED IN WILMINGTON, DE ORCHID CHEMICALS AND PHARMACEUTICALS LTD KESHAVA ORGANICS PVT LTD KESHAVA ORGANICS PVT LTD FELODIPINE (NON-STERILE BULK API) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA DEXCHLORPHENIRAMINE MALEATE AS MANUFACTURED IN MAHARASHTRA, INDIA CHLORPHENIRAMINE MALEATE AS MANUFACTURED IN MAHARASHTRA, INDIA

Page 643

4Q2012EXCEL DMF# 21357 C 21358 21359 A 21360 21361 A 21362 A 21363 A 21364 A 21365 A 21366 A 21367 A 21368 A 21369 21370 A 21371 I 21372 21373 21374 21375 21376 A 21377 A 21378 A 21379 A 21380 A 21381 A 21382 A II 2/26/2008 CHIROGATE INTERNATIONAL INC II 2/20/2008 CHEMI SPA II 2/25/2008 DISHMAN NETHERLANDS BV III 2/12/2008 AMPACET CORP III 2/12/2008 AMPACET CORP II 2/26/2008 APOTEX PHARMACHEM INC A A A I II II II II II 2/18/2008 2/25/2008 5/21/2008 5/23/2008 8/1/2008 MALLINCKRODT INC CHEMPACIFIC CORP JUBILANT LIFE SCIENCES LTD JUBILANT ORGANOSYS LTD JUBILANT LIFE SCIENCES LTD II 2/22/2008 PHARMATHEN INDUSTRIAL SA A II III 12/31/2007 2/16/2008 CADILA PHARMACEUTICALS LTD CMT MATERIALS INC II 2/1/2008 SAFC BIOSCIENCES INC II 2/27/2008 SPI PHARMA INC III 2/22/2008 POLYONE CORP IV 2/20/2008 FONA INTERNATIONAL INC II 2/26/2008 NIPPON PROTEIN CO LTD II 2/1/2008 SAFC BIOSCIENCES INC III 2/25/2008 A II III 2/15/2008 2/21/2008 A II V 2/21/2008 4/25/2008 FIS FABBRICA ITALIANA SINTETICI SPA ORCHID CHEMICALS AND PHARMACEUTICALS LTD ROLABO OUTSOURCING SL HYDRO ALUMINIUM ROLLED PRODUCTS GMBH PLASTOP PTY LTD STATUS Type SUBMIT DATE II 2/22/2008 HOLDER TEVA PHARMACEUTICAL INDUSTRIES LTD SUBJECT

4Q2012

FORMOTEROL FUMARATE DIHYDRATE AS MANUFACTURED IN MILAN, ITALY FOR TEVA GROUP QUETIAPINE FUMARATE AS MANUFACTURED IN VICENZA, ITALY STERILE PROCESSING DETAILS OF PLANT - 32 (ESUB) WALUJ, INDIA ATOVAQUONE AS MANUFACTURED IN ZARAGOZA, SPAIN HARP ALUMINIUM FOIL PACKAGING MATERIALS AS MANUFACTURED IN GREVENBROICH, GERMANY PACKAGING MATERIALS FOR DRUG PRODUCTS AS MANUFACTURED IN BRONKHORSTSPRUIT, SOUTH AFRICA EX-CELL(TM) 325 PF CHO (MODIFIED) CHO SERUM-FREE MEDIUM, PROTEIN-FREE W/585 MG/L L-GLUTAMINE, W/O SOY HYDROLYSATE, UF W/O SODIUM BICARBONATE AS MANUFACTURED IN DENVER, PA L-CYSTEINE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN TOCHIGI, JAPAN 894.132 PEPPERMINT FLAVOR (A NATURAL FLAVOR) AS MANUFACTURED IN GENEVA, IL CC10031855BG, CC00041542BG, CC00039937BG, CC00039936BG AS MANUFACTURED IN SAINT QUEN L AUMONE, FRANCE FOR POLYONE CORP BARCROFT(TM) CS 90 DC CALCIUM CARBONATE AS MANUFACTURED IN SEPTEMES-LESVALLONS, FRANCE EX-CELL(TM) 301 COMPLETE MEDIUM W/ L-GLUTAMINE, W/O SODIUM BICARBONATE AS MANUFACTURED IN DENVER, PA IRBESARTAN (POLYMORPHIC FORM-A) AS MANUFACTURED IN GUJARAT, INDIA THERMOFORM PLUG ASSIST MATERIALS FOR BLISTER PACKAGING AS MANUFACTURED IN ATTLEBORO, MA VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA FOR OMEGAPHARMA PHARMACEUTICALS LTD OXYMORPHONE BASE (ESUB) AS MANUFACTURED IN ST. LOUIS, MO CH011 (ACITRETIN) DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE, MD CANDESARTAN CILEXETIL (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA ESOMEPRAZOLE MAGNESIUM (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA ATORVASTATIN CALCIUM (AMORPHOUS) (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN CHOUTUPPAL, INDIA FOR APOTEX PHARMACHEM INC AMPACET PRODUCT 681726-PT AMBER PET MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; HEATH, OH;DERIDDER, LA; CARTERSVILLE, GA AMPACET PRODUCT 681725-PT AMBER PET MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; HEATH, OH;DERIDDER, LA; CARTERSVILLE, GA CHOLECALCIFEROL AS MANUFACTURED IN WEESP, THE NETHERLANDS AND STAROGARD GDANSKI, POLAND FOR DISHMAN NETHERLANDS B.V. DAPC (1,2-DIARACHIDOYL-SN-GLYCERO-3-PHOSPHOCHOLINE) AS MANUFACTURED IN PATRICA, ITALY BIMATOPROST AS MANUFACTURED IN TAOYUAN HSIEN, TAIWAN R.O.C.

Page 644

4Q2012EXCEL DMF# 21383 21384 21385 A 21386 A 21387 21388 A 21389 21390 A 21391 21392 A 21393 A 21394 I 21395 21396 A 21397 A 21398 A 21399 21400 A 21401 A 21402 21403 A 21404 A 21405 21406 I 21407 I 21408 21409 21410 A A A III III II 3/7/2008 3/7/2008 3/8/2008 IV 3/5/2008 A II IV 3/6/2008 3/5/2008 II 2/20/2008 LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LTD MEDICHEM MANUFACTURING MALTA LTD KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE POLIMERI EUROPA SPA POLIMERI EUROPA SPA SUN PHARMACEUTICAL INDUSTRIES LTD I II IV 2/28/2008 3/7/2008 II 2/29/2008 JIANGXI SYNERGY PHARMACEUTICAL CO LTD WATSON PHARMA PRIVATE LTD LENDELL MANUFACTURING INC A II II 4/22/2008 3/4/2008 IV 3/3/2008 III 2/12/2008 C II II 3/5/2008 3/6/2008 HOVIONE PHARMASCIENCE LTD IVERMECTIN AS MANUFACTURED IN TAIPA, MACAU S.A.R. II 3/5/2008 FDC LTD II 3/5/2008 APOTEX PHARMACHEM INC A II II 3/3/2008 3/5/2008 HEBEI YUXING BIO ENGINEERING CO LTD HETERO DRUGS LTD CYANOCOBALAMIN AS MANUFACTURED IN HEBEI, CHINA A II II 3/3/2008 3/20/2008 DR REDDYS LABORATORIES LTD ALKEM LABORATORIES LTD A III III 1/29/2008 2/15/2008 II 2/29/2008 STATUS Type SUBMIT DATE A A III II II 3/3/2008 2/21/2008 2/29/2008 HOLDER MITSUI CHEMICALS AMERICA INC TOMITA PHARMACEUTICAL CO LTD ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD ACTAVIS PHARMA MANUFACTURING PRIVATE LTD REMY AND GEISER GMBH HILLSIDE PLASTICS INC SUBJECT ADMER CP-30A AS MANUFACTURED IN LAPORTE, TX

4Q2012

DRIED ALUMINUM HYDROXIDE GEL AS MANUFACTURED IN TOKUSHIMA, JAPAN DULOXETINE HYDROCHLORIDE, NON-STERILE BULK DRUG AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA QUETIAPINE HEMIFUMARATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU, INDIA TUBULAR GLASS BOTTLES AS MANUFACTURED IN ALTENFELD, GERMANY HIGH DENSITY POLYETHYLENE CONTAINERS AS MANUFACTURED IN TURNERS FALLS, MA ZOLEDRONIC ACID TRIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA LAMOTRIGINE (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA FOR ALKEM LABORATORIES LTD

CYCLOBENZAPRINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA PERINDOPRIL TERT-BUTYLAMINE AS MANUFACTURED IN ONTARIO, CANADA AND BANGALORE, INDIA FOR APOTEX PHARMACHEM INC LEVALBUTEROL HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA STATE, INDIA

CALYX CHEMICALS AND PHARMACEUTICALS CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA LTD AMPACET CORP 682084 PT AMBER PET AS MANUFACTURED IN TERRE HAUTE, IN; HEATH, OH;DERIDDER, LA; CARTERSVILLE, GA 3M DRUG DELIVERY SYSTEMS ACETYLOLIGOLACTIC ACID HYDROXYETHYLUREA ESTER[OLA-72] AS MANUFACTURED IN ST. PAUL, MN FRESENIUS KABI ONCOLOGY LTD GEMCITABINE (ESUB) AS MANUFACTURED IN WEST BENGAL, INDIA BASF PHARMA EVIONNAZ SA TROSPIUM CHLORIDE AS MANUFACTURED IN EVIONNAZ, SWITZERLAND AND SAINTVULBAS, FRANCE FOR BASF ORGAMOL PHARMA SOLUTIONS SA GABAPENTIN AS MANUFACTURED IN JIANGXI PROVINCE, CHINA RAMIPRIL USP AS MANUFACTURED IN MAHARASHTRA, INDIA OPTIPOL(TM) PREPOLYMER AND MEDICAL GRADE FLEXIBLE POLYURETHANE FOAM AS MANUFACTURED IN ST CHARLES, MI MYCOPHENOLIC ACID (NON STERILE BULK FORM) AS MANUFACTURED IN GUANGDONG PROVINCE, CHINA MED-200140/M DRUG SUBSTANCE AS MANUFACTURED IN HAL FAR, MALTA 5X00118 SHEFFIELD COATING SYSTEM WHITE AS MANUFACTURED IN NORWICH, NY 5X00120 SHEFFIELD COATING SYSTEM WHITE ENT AS MANUFACTURED IN NORWICH, NY FLEXIRENE MS 40 A AS MANUFACTURED IN DUNKERQUE, FRANCE FLEXIRENE MR 50 A AS MANUFACTURED IN DUNKERQUE, FRANCE VALPROIC ACID USP AS MANUFACTURED IN MAHARASHTRA, INDIA

Page 645

4Q2012EXCEL DMF# 21411 I 21412 21413 A 21414 21415 21416 I 21417 21418 A 21419 A 21420 21421 21422 21423 I 21424 A 21425 A 21426 21427 21428 21429 21430 A 21431 21432 21433 21434 A 21435 A 21436 A 21437 21438 21439 N A A II II 3/11/2008 3/14/2008 NOT AN ASSIGNED NUMBER LUPIN LTD AMOLI ORGANICS PVT LTD III 4/7/2008 TRICORBRAUN IV 3/5/2008 BIOGRUND GMBH A A A IV III III II 3/10/2008 3/14/2008 3/14/2008 3/17/2008 UNGERER AND CO REXAM PHARMA GMBH REXAM PHARMA GMBH DAEWOONG BIO INC A A A A II II III III II 3/17/2008 3/13/2008 3/11/2008 3/11/2008 3/13/2008 II 3/8/2008 II 3/10/2008 A A A III III II II 3/10/2008 3/10/2008 3/14/2008 3/7/2008 SIBO G DOO SIBO G DOO GLENMARK GENERICS LTD III 3/10/2008 SIBO G DOO A II III 3/11/2008 3/10/2008 A A II III IV 3/5/2008 10/2/2007 3/5/2008 A II II 3/7/2008 3/12/2008 FARMAK AS BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG SUN PHARMACEUTICAL INDUSTRIES LTD CELGARD LLC KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE RA CHEM PHARMA LTD SIBO G DOO STATUS Type SUBMIT DATE III 3/10/2008 HOLDER STELLA KUNSTSTOFFTECHNIK GMBH SUBJECT

4Q2012

DROP-DISPENSING BOTTLES 3 ML & 6 ML WITH SZ14 NECK FINISH, AMBER AND SCREW CAPS SZ14 BLUE WITH BRUSH AS MANUFACTURED IN SUCY-EN-BRIE, FRANCE AND IN ELTVILLE, GERMANY FOR STELLA KUNSTSTOFFTECHNIK GMBH ESZOPICLONE AS MANUFACTURED IN OLOMOUC, CZECH REPUBLIC PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN INGELHEIM AM RHEIN, GERMANY LEVETIRACETAM AS MANUFACTURED IN GUJARAT, INDIA CELGARD 2400 SEMI-PERMEABLE MEMBRANE AS MANUFACTURED IN CHARLOTTE, NC 5X00119 SHEFFIELD COATING SYSTEM CLEAR ENT AS MANUFACTURED IN NORWICH, NY LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CHILD RESISTANT CLOSURE CRP-045-F AS MANUFACTURED IN SKOFJA LOKA, SLOVENIA EU CHILD RESISTANT CLOSURE CRP-045-FE AS MANUFACTURED IN SKOFJA LOKA, SLOVENIA EU CONTAINER 60ML, V-045-060 AS MANUFACTURED IN SKOFJA LOKA, SLOVENIA EU CONTAINER 120ML, V-055-120 AS MANUFACTURED IN SKOFJA LOKA, SLOVENIA EU TAZAROTENE AS MANUFACTURED IN GUJARAT STATE, INDIA

SHANGHAI YOUNGGREEN BIOTECH CO LTD MYCOPHENOLATE MOFETIL (NON-STERILE ACTIVE INGREDIENT) AS MANUFACTURED IN ZHEJIANG, CHINA FOR SHANGHAI YOUNGGREEN BIOTECH CO LTD SHANDONG FANGXING TECHNOLOGY CARPROFEN (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN SHANDONG DEVELOPMENT CO LTD PROVINCE, CHINA WORLD JIANGSU INDUSTRY CO LTD RAPAMYCIN/SIROLIMUS (NON-STERILE, ACTIVE INGREDIENT) AS MANUFACTURED IN FUJIANG PROVINCE, CHINA DR REDDYS LABORATORIES LTD LANSOPRAZOLE FORM-1 AS MANUFACTURED IN SRIKAKULAM DISTRICT, INDIA MEDICHEM MANUFACTURING MALTA LTD MAK AMPOULES PVT LTD MAK AMPOULES PVT LTD FARMABIOS S P A MED-201100/M AS MANUFACTURED IN HAL FAR, MALTA TUBULAR VIALS USP TYPE-1 AS MANUFACTURED IN THANE DISTRICT, INDIA GLASS AMPOULES USP TYPE-I AS MANUFACTURED IN THANE, INDIA FLUOCINONIDE, MICRONIZED BP/USP AS MANUFACTURED IN GROPELLO CAIROLI, ITALY ARTIFICIAL BUBBLEGUM FLVP FC-1153 AS MANUFACTURED IN BETHLEHEM, PA CLOSED VIAL AS MANUFACTURED IN NEUENBURG, GERMANY FLIP AWAY CAP AS MANUFACTURED IN NEUENBURG, GERMANY URSODIOL USP (URSODEOXYCHOLIC ACID)AS MANUFACTURED IN KYONGGI-DO, KOREA AQUAPOLISH, PRE-MIXED EXCIPIENTS SYSTEM FOR FILM COATING AS MANUFACTURED IN HUENSTETTEN, GERMANY DRY KEEP DESICCANT (ESUB) AS MANUFACTURED BY STANDRIDGE COLOR CORPORATION IN SOCIAL CIRCLE, GA FOR TRICORBRAUN IMIPRAMINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT STATE, INDIA

Page 646

4Q2012EXCEL DMF# 21440 A 21441 A 21442 21443 21444 21445 A 21446 21447 A 21448 II 5/9/2008 XOMA US LLC A II II 3/19/2008 3/21/2008 SUN PHARMACEUTICAL INDUSTRIES LTD DR REDDYS LABORATORIES LTD A A A II II II II 3/20/2008 3/18/2008 3/20/2008 3/19/2008 SMS PHARMACEUTICALS LTD MEDICHEM MANUFACTURING MALTA LTD DIPHARMA FRANCIS SRL DAINIPPON SUMITOMO PHARMA CO LTD FAMOTIDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA MED-201950/E AS MANUFACTURED IN GIRONA, SPAIN II 12/8/2007 STATUS Type SUBMIT DATE II 3/18/2008 HOLDER APOTEX PHARMACHEM INC SUBJECT

4Q2012

PAROXETINE HYDROCHLORIDE ANHYDROUS USP (PAX) AS MANUFACTURED IN TOLUCA, MEXICO, ANDHRA PRADESH, INDIA, AND BRANTFORD, CANADA FOR APOTEX PHARMACHEM INC

YANCHENG XINYI PHARM AND CHEM CO LTD EXEMESTANE (NON-STERILE, BULK FORM) AS MANUFACTURED IN JIANGSU, CHINA

IBUPROFEN LYSINE SALT AS MANUFACTURED IN CARONNO PERTUSELLA, ITALY RANIRESTAT (AS-3201) AS MANUFACTURED IN FUKUSHIMA, JAPAN FOR DAINIPPON SUMITOMO PHARMA CO LTD RISPERIDONE USP AS MANUFACTURED IN GUJARAT, INDIA RISEDRONATE SODIUM HEMIPENTAHYDRATEAS MANUFACTURED IN ANDHRA PRADESH, INDIA CELL LINE (SOURCE, HISTORY AND GENERATION ) FOR SCH 900105 (ESUB) AS MANUFACTURED IN BERKELEY, CA

A 21449 21450 21451 A 21452 21453 21454 A 21455 21456 21457 21458 21459 A 21460 21461 21462 21463 21464 21465 A 21466 A 21467 A 21468 21469 A A II II 3/28/2008 3/27/2008 EXCELLA GMBH EXCELLA GMBH ATOVAQUONE AS MANUFACTURED IN FEUCHT, GERMANY RIVASTIGMINE TARTRATE (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY II 3/24/2008 II 7/18/2007 A A A A A IV II II II III II 3/26/2008 3/26/2008 3/25/2008 3/3/2008 3/26/2008 3/18/2008 HALL BIOSCIENCE CADILA HEALTHCARE LTD CADILA HEALTHCARE LTD SEWON CELLONTECH CO LTD CODING PRODUCTS A A A A II II II II III 3/24/2008 3/24/2008 3/24/2008 3/24/2008 3/18/2008 A A III IV II 3/3/2008 3/6/2008 3/1/2008 A A II III IV 4/16/2008 3/21/2008 3/20/2008 IPCA LABORATORIES LTD POLIMERI EUROPA SPA MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS RAJESH PLASTICS HEALTHCAPS INDIA LTD ZHEJIANG HISOAR PHARMACEUTICAL CO LTD CHUANNAN BRANCH IRVINE SCIENTIFIC SALES CO IRVINE SCIENTIFIC SALES CO IRVINE SCIENTIFIC SALES CO IRVINE SCIENTIFIC SALES CO COLORTECH INC ETODOLAC (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA FLEXIRENE MT 40 A AS MANUFACTURED IN DUNKERQUE, FRANCE 709039 ARTIFICIAL BUBBLE GUM FLAVOR AS MANUFACTURED INCLARK, NJ PRIMARY PACKAGING MATERIAL AS MANUFACTURED IN MAHARASHTRA, INDIA EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN PUNJAB, INDIA METOPROLOL SUCCINATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA FMDF-9 (KIRIN) AS MANUFACTURED IN SANTA ANA, CA KI NSM-15 (KIRIN) AS MANUFACTURED IN SANTA ANA, CA KI NSM-16 (KIRIN) AS MANUFACTURED IN SANTA ANA, CA FMDF-10 (KIRIN) AS MANUFACTURED IN SANTA ANA, CA 11629-09 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN AND BRAMPTON, CANADA ZYTAN (GALLOQUINATE) AS MANUFACTURED IN MALLUSK, NORTHERN IRELAND PROGUANIL HYDROCHLORIDE PH EUR AS MANUFACTURED IN GUJARAT, INDIA LETROZOLE USP AS MANUFACTURED IN GUJARAT, INDIA ATELOCOLLAGEN AS MANUFACTURED IN SEOUL, KOREA 801 TP (THERMAL TRANSFER RIBBON) AS MANUFACTURED IN KALKASKA, MI

ST GOBAIN PERFORMANCE PLASTICS CORP TYGON 33701B BRAID-REINFORCED SILICONE HOSE AS MANUFACTURED IN BEAVERTON, MI ZHEJIANG HUAHAI PHARMACEUTICAL CO TELMISARTAN AS MANUFACTURED IN ZHEJIANG, CHINA LTD LUPIN LTD NABUMETONE (MICRONISED) USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA

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4Q2012EXCEL DMF# 21470 21471 21472 21473 21474 A 21475 A 21476 21477 A 21478 21479 21480 21481 21482 21483 21484 21485 A 21486 21487 A 21488 21489 21490 21491 21492 21493 21494 A 21495 21496 A 21497 A 21498 21499 A 21500 21501 A A II III 3/29/2008 4/4/2008 OLON SPA PLASTUBE NORTH AMERICA A II III 3/31/2008 3/31/2008 LUPIN LTD HYOSUNG CORP III 3/31/2008 INGENIA POLYMERS CORP A II III 4/3/2008 3/31/2008 UQUIFA MEXICO SA DE CV INGENIA POLYMERS CORP RABEPRAZOLE SODIUM AS MANUFACTURED IN MORELOS, MEXICO A A A A A A II II IV IV IV II V 3/31/2008 3/28/2008 3/26/2008 3/18/2008 3/18/2008 3/28/2008 5/1/2008 LUPIN LTD LUPIN LTD VASA PHARMACHEM PVT LTD VASA PHARMACHEM PVT LTD VASA PHARMACHEM PVT LTD LUPIN LTD NOVO NORDISK INC A II II 3/31/2008 4/1/2008 ACS DOBFAR SPA APOTEX PHARMACHEM INC A A A A A P A II II 3/25/2008 3/31/2008 II II II II II 3/29/2008 3/25/2008 3/26/2008 3/24/2008 4/1/2008 MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD MEDICHEM SA IND SWIFT LABORATORIES LTD CADILA HEALTHCARE LTD *** PENDING FILING REVIEW *** UNICHEM LABORATORIES LTD TORRENT PHARMACEUTICALS LTD NATEGLINIDE (ESUB) AS MANUFACTURED IN DHAR DISTRICT, INDIA A II II 3/22/2008 3/25/2008 MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD II 6/16/2008 IPCA LABORATORIES LTD STATUS Type SUBMIT DATE A A I A II II II II II 3/8/2008 3/15/2008 4/1/2008 3/28/2008 3/22/2008 HOLDER SAI LIFE SCIENCES LTD UNIMARK REMEDIES LTD DIXIE CHEMICAL CO INC POLYPEPTIDE LABORATORIES INC MYLAN LABORATORIES LTD SUBJECT IBUTILIDE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CEFPROZIL USP AS MANUFACTURED IN GUJARAT, INDIA NICOTINE USP AND NICOTINE USP-HP AS MANUFACTURED IN PASADENA, TX A-CORTICOTROPIN(1-24) ACETATE AS MANUFACTURED IN TORRANCE, CA

4Q2012

PIOGLITAZONE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA PROGUANIL HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA QUINAPRIL HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA ATORVASTATIN CALCIUM USP (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ESZOPICLONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA MED-200025/E AS MANUFACTURED IN GIRONA, SPAIN ACAMPROSATE CALCIUM AS MANUFACTURED IN PUNJAB, INDIA ZALEPLON AS MANUFACTURED IN GUJARAT, INDIA

DULOXETINE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN GUJARAT, INDIA IMIPENEM AND CILASTATIN (STERILE BULK) AS MANUFACTURED IN MILANO, ITALY VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA AND BRANTFORD, CANADA FOR APOTEX PHARMACHEM INC. SEVELAMER HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA MESALAMINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA MAGNESIUM STEARATE AS MANUFACTURED IN GUJARAT, INDIA VASAGEL (SODIUM STARCH GLYCOLATE) AS MANUFACTURED IN GUJARAT, INDIA VASALOSE (CROSCARMELLOSE SODIUM) AS MANUFACTURED IN GUJARAT, INDIA IMIPRAMINE PAMOATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA STERILIZATION VALIDATION INFORMATION (ESUB) IN BAGSVAERD, DENMARK

INGENIA POLYMERS 1026 HIGH PERFORMANCE WHITE FOR USE IN PACKAGING MATERIALS AS MANUFACTURED IN ONTARIO AND ALBERTA, CANADA AND HOUSTON, TEXAS FOR INGENIA POLYMERS CORP INGENIA POLYMERS 1027 HIGH PERFORMANCE WHITE FOR USE IN PACKAGING MATERIALS AS MANUFACTURED IN ONTARIO AND ALBERTA, CANADA AND HOUSTON, TEXAS FOR INGENIA POLYMERS CORP OMEPRAZOLE USP (ESUB) POLYPROPYLENE (TOPILENE J700-1, J800S, J801, R530, R530A) AS MANUFACTURED IN ULSAN, KOREA IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN RODANO, ITALY POLYFOIL TUBES AS MANUFACTURED IN QUEBEC, CANADA

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4Q2012EXCEL DMF# 21502 21503 21504 21505 A 21506 21507 21508 21509 21510 21511 A 21512 A 21513 21514 21515 21516 21517 21518 21519 A 21520 21521 21522 A 21523 A 21524 21525 21526 21527 21528 21529 A 21530 21531 A 21532 21533 21534 21535 A A C A II III II II 4/15/2008 4/12/2008 4/15/2008 4/15/2008 HARMAN FINOCHEM LTD ALUCON PUBLIC CO LTD HETERO LABS LTD ACS DOBFAR SPA A V III 4/9/2008 3/7/2008 BIOCON LTD MEDRAD INC A A A A A II IV II II II II 4/8/2008 4/7/2008 4/11/2008 4/11/2008 4/10/2008 5/24/2008 LUPIN LTD FONA INTERNATIONAL INC NEULAND LABORATORIES LTD CRYSTAL PHARMA SAU SEIKAGAKU CORP SUN PHARMACEUTICAL INDUSTRIES LTD II 4/8/2008 MSN LABORATORIES LTD I A II III 3/31/2008 3/28/2008 UNIV SOUTHERN CALIFORNIA LUPIN LTD FLEX ART FOIL LTD OMEPRAZOLE MAGNESIUM AS MANUFACTURED IN MAHARASHTRA, INDIA A I A A A A II II II IV II II II 3/31/2008 3/28/2008 4/7/2008 4/4/2008 4/9/2008 4/9/2008 4/9/2008 LUPIN LTD LUPIN LTD LONZA LTD UNGERER AND CO BIOVECTRA INC INDUSTRIALE CHIMICA SRL NEULAND LABORATORIES LTD II 3/31/2008 LUPIN LTD A A A A A II II II II II II 3/31/2008 3/31/2008 3/29/2008 3/31/2008 3/29/2008 4/8/2008 SUN PHARMACEUTICAL INDUSTRIES LTD ALEMBIC PHARMACEUTICALS LTD PARABOLIC DRUGS LTD LUPIN LTD ALEMBIC PHARMACEUTICALS LTD VANGA PRODUCTS PLASTICS INC OLANZAPINE AS MANUFACTURED IN MAHARASHTRA, INDIA CANDESARTAN CILEXETIL AS MANUFACTURED IN GUJARAT, INDIA STATUS Type SUBMIT DATE A A A III III II III 4/4/2008 4/4/2008 4/4/2008 8/18/2007 HOLDER PLASTUBE NORTH AMERICA PLASTUBE NORTH AMERICA EVERLIGHT CHEMICAL INDUSTRIAL CORP SUBJECT MONOLAYER TUBES AS MANUFACTURED IN QUEBEC, CANADA CO-EXTRUSION TUBES AS MANUFACTURED IN QUEBEC, CANADA LATANOPROST AS MANUFACTURED IN TAOYUAN HSIEN, TAIWAN

4Q2012

THE BOMBAY GLASS BLOWING INDUSTRIES NEUTRAL GLASS TUBULAR VIALS USP TYPE 1 AS MANUFACTURED IN GUJARAT, INDIA

CEFUROXIME ACID (API STARTING MATERIAL) AS MANUFACTURED IN IN PUNJAB, INDIA FLUVASTATIN SODIUM (MICRONIZED) USP (ESUB) METOPROLOL SUCCINATE USP AS MANUFACTURED IN GUJARAT, INDIA VANGA PHARMACEUTICAL AND NUTRACEUTICAL (VITAMIN) PLASTIC BOTTLES AS MANUFACTURED IN BRITISH COLUMBIA, CANADA CARVEDILOL PHOSPHATE (AMORPHOUS) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA QUETIAPINE FUMARATE AS MANUFACTURED IN MAHARASHTRA, INDIA MESALAMINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA EC-125 DRUG SUBSTANCE AS MANUFACTURED IN VISP, SWITZERLAND N/A BERRY FLAVOR FO-8432 AS MANUFACTURED IN BETHLEHEM, PA. DOCETAXEL AS MANUFACTURED IN CHARLOTTETOWN, CANADA NORGESTIMATE AS MANUFACTURED IN SARONNO, ITALY DORZOLAMIDE HYDROCHLORIDE FORM II USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

PLAIN AND PRINTED ALUMINIUM FOIL / GLASSINE / LAMINATES / CR FOIL AS MANUFACTURED IN HIMACHAL PRADESH, INDIA VORICONAZOLE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA 802.0004U ANISE TYPE FLAVOR, NATURAL AS MANUFACTURED IN GENEVA, IL ENTACAPONE (FORM-A) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ULIPRISTAL (VA2914), MICRONIZED AS MANUFACTURED IN BOECILLO, SPAIN SODIUM CHONDROITIN SULFATE (N) AS MANUFACTURED IN KANAGAWA, JAPAN RISEDRONATE SODIUM HEMIPENTAHYDRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA MANUFACTURING FACILITY OF BIOCON LIMITED AT BANGALORE, INDIA FLS-3 READY-TO-FILL SYRINGE AS MANUFACTURED IN NEUMUNSTER, GERMANY FOR MEDRAD INC DIVALPROEX SODIUM AS MANUFACTURED IN MAHARASHTRA, INDIA COLLAPSIBLE ALUMINIUM TUBES AS MANUFACTURED IN SAMUDPRAKARN, THAILAND PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA IMIPENEM (STERILE BULK) AS MANUFACTURED IN MILANO, ITALY

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4Q2012EXCEL DMF# 21536 A 21537 A 21538 A 21539 A 21540 21541 21542 A 21543 A 21544 A 21545 A 21546 21547 A II II 8/19/2008 7/3/2008 CIPLA LTD CIPLA LTD II 3/31/2008 SAFC BIOSCIENCES INC II 4/17/2008 II 4/18/2008 C A II IV II 4/17/2008 3/20/2008 4/17/2008 HETERO LABS LTD DAVID MICHAEL AND CO INC PORTON PHARMACEUTICAL LTD III 4/7/2008 IV 4/15/2008 MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS SAMSUNG MEDICAL RUBBER CO LTD III 4/9/2008 AMPACET CORP STATUS Type SUBMIT DATE III 3/24/2008 HOLDER AMPACET CORP SUBJECT

4Q2012

AMPACET 172963 LIME GREEN POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA AMPACET 101797 SLIP POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA AND DERIDDER, LA 708055 EUCALYPTUS OIL 70/75% AS MANUFACTURED IN CLARK, NJ RUBBER STOPPER, CONNECTOR AND GASKET AS MANUFACTURED IN GYEONGGI-DO, KOREA TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ARTIFICIAL STRAWBERRY FLAVOR #12006 AS MANUFACTURED IN PHILADELPHIA, PA

DEXRAZOXANE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, CHINA ABX ADVANCED BIOCHEMICAL COMPOUNDS MIBG DRUG SUBSTANCE AS MANUFACTURED IN RADEBERG, GERMANY FOR ABX GMBH ADVANCED BIOCHEMICAL COMPOUNDS GMBH LUITPOLD PHARMACEUTICALS INC SODIUM CHLORIDE INJECTION USP 0.9% 10ML VIAL AS MANUFACTURED IN SHIRLEY, NY EX-CELL(TM) NSO SERUM-FREE, CHEMICALLY DEFINED W/O L-GLUTAMINE W/O SODIUM BICARBONATE AS MANUFACTURED IN DENVER, PA TESTOSTERONE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA LEVONORGESTREL USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA

A 21548 A 21549 A 21550 A 21551 21552 21553 I 21554 21555 A 21556 A 21557 21558 A 21559 A 21560 A II 4/22/2008 II 4/15/2008 BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG MALLINCKRODT INC A II III 5/29/2008 4/9/2008 II 6/27/2008 ORCHID CHEMICALS AND PHARMACEUTICALS LTD CIPLA LTD VERRETUBEX A II III 4/17/2008 4/23/2008 MSN LABORATORIES LTD VARI SPA A A II II II 4/18/2008 4/21/2008 4/14/2008 LUPIN LTD SMS PHARMACEUTICALS LTD XIAN LIBANG PHARMACEUTICAL CO LTD IV 4/18/2008 II 4/17/2008 II 4/17/2008 VITALIFE LABORATORIES DIV ARCH PHARMALABS LTD SIBRA PHARMACEUTICALS LTD AN ARCH ENTERPRISE SUMITOMO SEIKA CHEMICALS CO LTD LAMIVUDINE USP (ESUB) AS MANUFACTURED IN HARYANA, INDIA LAMIVUDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA POLYETHYLENE OXIDE (PEO): A NON-IONIC WATER SOLUBLE THERMOPLASTIC RESIN AS MANUFACTURED IN HYOGO, JAPAN FENOFIBRATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA LANSOPRAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA IBUTILIDE FUMARATE, NON-STERILE BULK DRUG AS MANUFACTURED IN SHANXI PROVINCE, CHINA EZETIMIBE AS MANUFACTURED IN ANDHRA PRADESH, INDIA KEMP HFA METERED DOSE AEROSOL VALVES AS MANUFACTURED IN VALMADRERA, ITALY THN-CYCLIC (IMIPENEM INTERMEDIATE) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA OSELTAMIVIR PHOSPHATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDAI AMPOULES, VIALS AND CARTRIDGES MANUFACTURED IN TUBULAR GLASS TO CONTAIN PHARMACEUTICAL AND MEDICAL PRODUCTS AS MANUFACTURED IN NOGENT LE ROI, FRANCE DIGOXIN 20 MICROMETER AS MANUFACTURED IN INGELHEIM AM RHEIN, GERMANY SODIUM SULFATE USP ANHYDROUS MILLED POWDER (ESUB) AS MANUFACTURED IN ST LOUIS, MO Page 650

4Q2012EXCEL DMF# 21561 21562 A 21563 A 21564 A 21565 A 21566 A 21567 A 21568 A 21569 21570 A 21571 21572 A 21573 21574 C 21575 A 21576 A 21577 A 21578 21579 21580 A 21581 A 21582 A 21583 21584 21585 A 21586 A V 4/23/2008 STELMI SA A A II II II 4/24/2008 4/28/2008 4/30/2008 ZACH SYSTEM SPA CAYMAN PHARMA SRO CHEMO IBERICA SA MADRID II 4/29/2008 SIEMENS MOLECULAR IMAGING INC II 7/23/2008 BAYER SCHERING PHARMA AG A A II II II 4/28/2008 4/29/2008 7/23/2008 III 4/18/2008 II 4/29/2008 ZHEJIANG DONGDONG PHARMACEUTICAL CO LTD CCC PLASTICS CANADA COLORS AND CHEMICALS LTD YANGZHOU PHARMACEUTICAL CO LTD DIVIS LABORATORIES LTD BAYER SCHERING PHARMA AG II 4/25/2008 SAFC BIOSCIENCES INC A II II 5/2/2008 4/29/2008 TRACE LIFE SCIENCES INC APOTEX PHARMACHEM INC A II II 4/16/2008 2/13/2008 A III II 4/11/2008 4/24/2008 RELIANCE INDUSTRIES LTD VITALIFE LABORATORIES DIV ARCH PHARMALABS LTD BIOCON LTD ANTIBIOTICOS DO BRASIL LTDA III 4/11/2008 II 4/25/2008 V 5/21/2008 III 3/18/2008 III 3/18/2008 II 1/15/2008 STATUS Type SUBMIT DATE A III III 4/21/2008 4/15/2008 HOLDER REXAM HEALTHCARE OFFRANVILLE SAS SUBJECT 60 ML PILLJAR AS MANUFACTURED IN OFFRANVILLE, FRANCE

4Q2012

RUBY SURGICAL AND ALLIED PRODUCTS ABSORBENT COTTON/PURIFIED COTTON AS MANUFACTURED IN JALGAON, INDIA PRIVATE LTD YANCHENG XINYI PHARM AND CHEM CO LTD MEDROXYPROGESTERONE ACETATE(NON-STERILE BULK FORM) AS MANUFACTURED IN JIANGSU, CHINA CHONGQING ZHENGCHUAN GLASS CO LTD CONTAINERS FOR PARENTERAL PREPARATIONS MADE OF BOROSILICATE GLASS (TYPE I) TUBING AS MANUFACTURED IN CHONGQING, P.R. CHINA CHONGQING ZHENGCHUAN GLASS CO LTD CONTAINERS FOR PARENTERAL PREPARATIONS OF LOW-BOROSILICATE GLASS (TYPE I) TUBING AS MANUFACTURED IN CHONGQING, CHINA NATIONAL INSTITUTES HEALTH NATIONAL ANTHRAX ANIMAL MODEL INSTITUTE ALLERGY INFECTIOUS DISEASES AMRI RENSSELAER INC SUB ALBANY HYDROXYCHLOROQUINE SULFATE, USP DRUG SUBSTANCE AS MANUFACTURED IN MOLECULAR RESEARCH INC RENSSELAER, NY RELIANCE INDUSTRIES LTD POLYPROPYLENE (PP) REPOL SRM250NC AS MANUFACTURED IN MAHARASHTRA, INDIA POLYPROPYLENE (PP) REPOL H110MA AS MANUFACTURED IN MAHARASHTRA, INDIA ZIDOVUDINE USP (ESUB) AS MANUFACTURED IN HARYANA, INDIA SIROLIMUS DRUG SUBSTANCE AS MANUFACTURED IN BANGALORE, INDIA ARGININE USP, STERILE BULK MPM180AF3 AS MANUFACTURED IN COSMOPOLIS, BRAZIL INDIUM-111 CHLORIDE SOLUTION (ESUB) AS MANUFACTURED IN DENTON, TEXAS ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE AS MANUFACTURED IN BRANTFORD, CANADA EX-CELL 325 PF CHO (MODIFIED) PRODUCT NO. 63131 AS MANUFACTURED IN ANDOVER, UNITED KINGDOM FOR SAFC BIOSCIENCES INC TORSEMIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA WHITE MB20-9576 POLYETHYLENE COLOUR CONCENTRATE AS MANUFACTURED IN ONTARIO, CANADA ETODOLAC USP AS MANUFACTURED IN JIANGSU, CHINA VIGABATRIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA RIVAROXABAN COATED TABLETS, 10 MG (ESUB) AS MANUFACTURED IN LEVERKUSEN, GERMANY RIVAROXABAN (MICRONIZED) DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN WUPPERTAL AND LEVERKUSEN, GERMANY SODIUM FLUORIDE F18 INJECTION AS MANUFACTURED IN HOUSTON, TX, CULVER CITY & PALO ALTO, CA, DURHAM, NC, ST. LOUIS, MO, WOBURN, MA, AND HACKENSACK, NJ FOR SIEMENS MOLECULAR IMAGING INC CARVEDILOL PHOSPHATE AS MANUFACTURED IN LONIGO, ITALY EPOPROSTENOL SODIUM AS MANUFACTURED IN NERATOVICE, CZECH REPUBLIC RABEPRAZOLE SODIUM (PROCESS I) AS MANUFACTURED IN MADRID, SPAIN FOR CHEMO IBERICA SA MADRID STERILE ELASTOMERIC CLOSURE AND ITEMS AS MANUFACTURED IN GRANVILLE CEDEX, FRANCE

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4Q2012EXCEL DMF# 21587 21588 A 21589 A 21590 21591 A 21592 A 21593 I 21594 21595 A 21596 A 21597 A 21598 A 21599 A 21600 A 21601 A 21602 A 21603 A 21604 21605 21606 A 21607 21608 21609 21610 A 21611 21612 21613 A A A III II IV 3/27/2008 5/9/2008 5/13/2008 A A A II III III II 4/25/2008 4/24/2008 4/15/2008 5/8/2008 INTERNATIONAL MEDICAL IMPLANT IMI PERMIAN PLASTICS INC JAMNADAS INDUSTRIES ACTAVIS PHARMA MANUFACTURING PRIVATE LTD YONWOO CO LTD HETERO LABS LTD INTERNATIONAL SPECIALTY PRODUCTS A A II II II 4/29/2008 4/23/2008 5/8/2008 WOCKHARDT LTD WOCKHARDT LTD KYOWA HAKKO KIRIN CO LTD II 5/8/2008 II 5/8/2008 IV 5/6/2008 IV 5/7/2008 IV 5/6/2008 IV 5/7/2008 IV 5/7/2008 IV 5/7/2008 KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE NANTONG JINGHUA PHARMACEUTICAL CO LTD SIGNA SA DE CV A II II 5/5/2008 5/7/2008 ACS DOBFAR SPA NATCO PHARMA LTD CILASTATIN SODIUM (STERILE BULK) AS MANUFACTURED IN MILANO, ITALY SHANGHAI AJINOMOTO AMINO ACID CO LTD II 7/24/2008 JANSSEN ORTHO LLC C II II 4/29/2008 5/1/2008 III 5/1/2008 STATUS Type SUBMIT DATE A II II 4/30/2008 4/30/2008 HOLDER BASF CORP SUBJECT SODIUM IBUPROFEN DIHYDRATE AS MANUFACTURED IN BISHOP, TX

4Q2012

JOHNSON MATTHEY INC PHARMACEUTICAL MORPHINE SULFATE USP AS MANUFACTURED IN WEST DEPTFORD, NJ MATERIALS GROUP PRESSPART GMBH CO KG ALUMINIUM ALLOY METERED DOSE INHALER CONTAINERS (CANS) INTERNALLY COATED WITH FLUOROPOLYMER AS MANUFACTURED IN MARSBERG, GERMANY MACFARLAN SMITH LTD NALTREXONE HYDROCHLORIDE AS MANUFACTURED IN SCOTLAND, UNITED KINGDOM FARMABIOS S P A TRIAMCINOLONE ACETONIDE MICRONIZED STERILE AS MANUFACTURED IN GROPELLO CAIROLI, ITALY RIVAROXABAN 10 MG FILM COATED TABLETS (ESUB) AS MANUFACTURED IN GURABO, PUERTO RICO

PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA 5X00026 LACTOSE MONOHYDRATE NF INHALATION 120MS AS MANUFACTURED IN NORWICH, NY 5X00066 LACTOSE MONOHYDRATE NF INHALATION 120M AS MANUFACTURED IN NORWICH, NY 5X00065 LACTOSE MONOHYDRATE NF INHALATION 80M AS MANUFACTURED IN NORWICH, NY 5X00029 LACTOSE ANHYDROUS NF INHALATION 120MS AS MANUFACTURED IN NORWICH, NY 5X00064 LACTOSE MONOHYDRATE NF INHALATION 40M AS MANUFACTURED IN NORWICH, NY 5X00032 LACTOSE ANHYDROUS NF INHALATION 40M AS MANUFACTURED IN NORWICH, NY PRIMIDONE (ESUB) PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN TOLUCA, MEXICO FOR APOTEX PHARMACHEM INC DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA LANSOPRAZOLE USP AS MANUFACTURED IN GUJARAT, INDIA ASKP1240 MONOCLONAL ANTIBODY DRUG SUBSTANCE AND DRUG PRODUCT AS MANUFACTURED IN GUNMA, JAPAN BIOPIK AS MANUFACTURED IN PORNICHET, FRANCE DRUG PRODUCT CONTAINER AS MANUFACTURED IN O'FALLON, MO RUBBER CLOSURES AS MANUFACTURED IN GUJARAT, INDIA IMIQUIMOD, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN TAMIL NADU, INDIA AS30-TC CONTAINER / CLOSURE AS MANUFACTURED IN INCHEON, KOREA EMTRICITABINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ADVANTIA PERFORMANCE AS MANUFACTURED IN NORRISTOWN, PA FOR INTERNATIONAL SPECIALTY PRODUCTS

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4Q2012EXCEL DMF# 21614 A 21615 21616 A 21617 21618 21619 21620 21621 21622 A 21623 21624 A 21625 A 21626 21627 21628 A 21629 21630 21631 A 21632 21633 21634 21635 A 21636 A 21637 A 21638 A 21639 A 21640 21641 21642 A 21643 A II 5/14/2008 SANQUIN BLOOD SUPPLY FDN A N II 5/16/2008 II 5/19/2008 EMCURE PHARMACEUTICALS LTD NOT AN ASSIGNED NUMBER LONZA AG V 2/4/2008 IONISOS IV 5/19/2008 II 5/16/2008 II 7/22/2008 A A C IV II II II 5/16/2008 5/19/2008 5/20/2008 6/27/2008 QUALICAPS ROMANIA EMCURE PHARMACEUTICALS LTD FORMOSA LABORATORIES INC ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD LABORATORIO CHIMICO INTERNAZIONALE SPA WACKER CHEMIE AG A A II II II 5/16/2008 5/19/2008 5/19/2008 SIGMA ALDRICH MANUFACTURING LLC TORRENT PHARMACEUTICALS LTD TORRENT PHARMACEUTICALS LTD A A II III III 5/16/2008 5/15/2008 5/16/2008 II 3/25/2008 A III II 5/15/2008 5/8/2008 POLYCINE GMBH A A A A A II IV II II II II 5/12/2008 5/15/2008 5/15/2008 8/19/2009 7/17/2008 4/12/2008 A II II 5/10/2008 5/12/2008 STATUS Type SUBMIT DATE II 5/9/2008 HOLDER SUBJECT

4Q2012

SHENZHEN HAPPY PHARMACEUTICALS LTD PHENYLEPHRINE HYDROCHLORIDE AS MANUFACTURED IN SHANDONG PROVINCE, CHINA FOR SHENZHEN HAPPY PHARMACEUTICALS LTD. PARABOLIC DRUGS LTD CEFUROXIME AXETIL USP (CRYSTALLINE) AS MANUFACTURED IN PUNJAB, INDIA SIBRA PHARMACEUTICALS LTD AN ARCH ENTERPRISE SYN TECH CHEM AND PHARM CO LTD CAMBRIDGE ISOTOPE LABORATORIES INC HETERO DRUGS LTD CIPLA LTD CIPLA LTD JIANGSU ZW PHARMACEUTICALS CO LTD STAVUDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA ATENOLOL AS MANUFACTURED IN HSIN-YING, TAIWAN R.O.C. L-LEUCINE (U-13C6) AS MANUFACTURED IN ANDOVER, MA SILDENAFIL CITRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CAPECITABINE USP (ESUB) AS MANUFACTURED IN MUMBAI, INDIA TOPOTECAN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MUMBAI, INDIA ZOPICLONE API (EP)NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU, P.R. CHINA INERTA101 FILM AS MANUFACTURED IN SCHIFFWEILER, GERMANY

ZHEJIANG HISUN PHARMACEUTICAL CO LTD IVERMECTIN USP (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) FOR HUMAN USE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA LUSOCHIMICA SPA NICARDIPINE HYDROCHLORIDE (INTENDED FOR PARENTERAL USE) AS MANUFACTURED IN LOMAGNA, ITALY ZACH SYSTEM CORP DORZOLAMIDE HYDROCHLORIDE AS MANUFACTURED IN LA PORTE, TX NATIONAL LABEL CO TEKNOR APEX CO HEAT SEAL ADHESIVE 441BL AS MANUFACTURED IN CONSHOHOCKEN, PA MONPRENE MP-2024A NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX COMPANY GALACTOMANNAN C (DAVANAT) AS MANUFACTURED IN ST. LOUIS, MO RISPERIDONE DRUG SUBSTANCE AS MANUFACTURED IN GUJARAT, INDIA PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE DRUG SUBSTANCE AS MANUFACTURED IN GUJARAT, INDIA EMPTY GELATIN CAPSULES AS MANUFACTURED IN BUCHAREST, ROMANIA OLSALAZINE SODIUM AS MANUFACTURED IN MAHARASHTRA, INDIA LEVONORGESTREL AS MANUFACTURED IN TAOYUAN, TAIWAN DULOXETINE HYDROCHLORIDE (NON-STERILE BULK API) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA LANSOPRAZOLE (NON-STERILE BULK API) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA PROPENTOFYLLINE INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER AS MANUFACTURED IN SEGRATE, ITALY HYDROXYPROPYL BETA CYCLODEXTRIN AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR WACKER FINE CHEMICALS FACILITY AND PROCEDURES FOR ELECTRON BEAM STERILIZATION IN CHAUMESNIL, FRANCE DEFERIPRONE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ETH06 (TRABECTEDIN DRUG SUBSTANCE INTERMEDIATE)AS MANUFACTURED IN VISP, SWITZERLAND HOLOTRANSFERRIN AS MANUFACTURED IN AMSTERDAM, THE NETHERLANDS AND BRUSSELS, BELGIUM FOR SANQUIN BLOOD SUPPLY FOUNDATION

Page 653

4Q2012EXCEL DMF# 21644 A 21645 A 21646 A 21647 21648 A 21649 A 21650 21651 A 21652 21653 A 21654 21655 21656 21657 A 21658 I 21659 21660 A 21661 A 21662 21663 21664 21665 21666 21667 21668 A 21669 A 21670 21671 21672 A A A II II IV 5/13/2008 5/27/2008 5/29/2008 II 5/25/2008 JIANGSU TASLY DIYI PHARMACEUTICAL CO LTD AREVIPHARMA GMBH PARABOLIC DRUGS LTD MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS A A A A A A II II II II II II II 5/21/2008 5/20/2008 5/20/2008 5/28/2008 5/28/2008 5/20/2008 5/29/2008 KESHAVA ORGANICS PVT LTD INDUSTRIALE CHIMICA SRL KOREA UNITED PHARMACEUTICALS INC ALDRICH CHEMICAL CO ISOTEC FACILITY MACLEODS PHARMACEUTICALS LTD HTI TECHNOLOGIES AVANTI POLAR LIPIDS INC III 5/29/2008 DONGSIN TUBE GLASS IND CO LTD I II II 5/30/2008 5/20/2008 AMRI INDIA PVT LTD E BEGEROW GMBH AND CO II 5/23/2008 TEVA PHARMACEUTICAL INDUSTRIES LTD A N A IV II 6/3/2008 5/26/2008 II 5/21/2008 A II II 5/23/2008 5/23/2008 ENALTEC LABS PVT LTD CHONGQING HUAPONT PHARMACEUTICAL CO LTD HALCYON LABS PRIVATE LTD NOT AN ASSIGNED NUMBER UNGERER AND CO SIGNA SA DE CV A II III 5/22/2008 5/21/2008 AARTI DRUGS LTD ROHM AND HAAS CO III 4/18/2008 ADHESIVES RESEARCH INC A III III 5/14/2008 5/14/2008 UNGERER AND CO N E W PLASTICS CORP III 5/20/2008 POREX TECHNOLOGIES GMBH III 5/21/2008 STATUS Type SUBMIT DATE III 5/16/2008 HOLDER SUBJECT

4Q2012

O BERK CO HEALCARE PACKAGING GROUP 2 OZ / 60ML TYPE 3 GLASS OBLONG BOTTLES, ITEM CODE 5403009 AS MANUFACTURED IN HSINCHU, TAIWAN FORO. BERK COMPANY, HEALTHCARE PACKAGING GROUP FOR O BERK CO HEALCARE PACKAGING GROUP ROHM AND HAAS CO ADCOTE 35D9 AS MANUFACTURED IN ELK GROVE VILLAGE, IL FOR ROHM AND HAAS CO FILTER DISC PART NS-7363 COMPONENT USED IN A DRUG POWDER INHALER AS MANUFACTURED IN AACHEN, GERMANY FOR POREX CORPORATION ARTIFICIAL GRAPE FLAVOR FN-5393 AS MANUFACTURED IN BETHLEHEM, PA HIGH DENSITY POLYETHYLENE PLASTIC CONTAINERS AS MANUFACTURED IN LUXEMBURG, WI MA-73B AS MANUFACTURED IN GLEN ROCK, PA AND LIMERICK, IRELAND FOR ADHESIVES RESEARCH INC RALOXIFENE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA ADCOTE HS 35X124 AS MANUFACTURED IN ELK GROVE VILLAGE AND RINGWOOD, IL FOR ROHM AND HAAS CO TROSPIUM CHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA ISOTRETINOIN AS MANUFACTURED IN CHONGQING, P.R. CHINA MOMETASONE FUROATE USP AS MANUFACTURED IN GUJARAT, INDIA NATURAL PEPPERMINT FLAVOR #2303 AS MANUFACTURED IN BETHLEHEM, PA TOPIRAMATE USP AS MANUFACTURED IN TOLUCA, MEXICO FOR APOTEX PHARMACHEM INC TRIAMCINOLONE ACETONIDE MICRONIZED STERILE AS MANUFACTURED IN SANTIA, ITALY ATENOLOL, USP DRUG SUBSTANCE AS MANUFACTURED IN MAHARASHTRA, INDIA BECOCAP DEPTH FILTER CAPSULE AS MANUFACTURED IN LANGENLONSHEIM, GERMANY USP TYPE I BROSILICATE VIALS AND AMPOULES AS MANUFACTURED IN INCHEON, KOREA BROMPHENIRAMINE MALEATEAS MANUFACTURED IN MAHARASHTRA, INDIA INDAPAMIDE AS MANUFACTURED IN SARONNO(VARESE), ITALY FELODIPINE AS MANUFACTURED IN YEONGI-GUN CHUNGNAM, REPUBLIC OF KOREA METHACETIN-METHOXY-13C, MBT GRADE AS MANUFACTURED IN MIAMISBURG, OH EFAVIRENZ AS MANUFACTURED IN GUJARAT, INDIA HYDROXYAPATITE COATINGS AS MANUFACTURED IN DECINES, FRANCE SYNTHETIC MONOPHOSPHORYL LIPID A (SMPLA) AS MANUFACTURED IN ALABASTER, AL TEMOZOLOMIDE (BULK, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN JIANGSU, CHINA BICALUTAMIDE AS MANUFACTURED IN RADEBEUL, GERMANY CEFUROXIME AXETIL USP (AMORPHOUS) AS MANUFACTURED IN PUNJAB, INDIA 700076 NATURAL & ARTIFICIAL GRAPE FLAVOR AS MANUFACTURED IN CLARK, NJ

Page 654

4Q2012EXCEL DMF# 21673 A 21674 21675 A 21676 21677 21678 21679 A 21680 A 21681 A 21682 21683 21684 A 21685 A 21686 I 21687 21688 A 21689 A 21690 A 21691 21692 21693 21694 21695 21696 A 21697 21698 A 21699 A 21700 A 21701 21702 A A II II 6/7/2008 6/16/2008 II 6/9/2008 II 7/31/2008 A III II 6/5/2008 7/25/2008 BASELL POLYOLEFINE ITALIA SRL ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD JIANGXI SYNERGY PHARMACEUTICAL CO LTD CADILA PHARMACEUTICALS LTD FORMOSA LABORATORIES INC I A C A A II II II II II III 6/12/2008 6/7/2008 5/28/2008 6/12/2008 4/9/2008 5/16/2008 II 6/27/2008 II 7/23/2008 ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD CARDINAL HEALTH 414 LLC ERREGIERRE SPA MSN LABORATORIES LTD PIRAMAL HEALTHCARE LTD SOHAN HEALTHCARE PVT LTD AMPACET CORP A II II 6/11/2008 6/7/2008 II 5/4/2008 ZHEJIANG SUPOR PHARMACEUTICALS CO LTD SIFAVITOR SRL AUROBINDO PHARMA LTD IV 6/6/2008 A A II III IV 6/5/2008 6/5/2008 6/6/2008 GLOCHEM INDUSTRIES LTD ROHM AND HAAS CO MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS CAPSUGEL II 6/10/2008 DAIICHI FINE CHEMICAL CO LTD II 8/12/2008 IPCA LABORATORIES LTD A A A II II II II 7/25/2008 9/20/2008 10/20/2008 7/1/2008 A II II 6/4/2008 6/4/2008 RPG LIFE SCIENCES LTD JOHNSON MATTHEY PHARMACEUTICAL MATERIALS IPCA LABORATORIES LTD IPCA LABORATORIES LTD IPCA LABORATORIES LTD IPCA LABORATORIES LTD STATUS Type SUBMIT DATE II 5/26/2008 HOLDER JENKEM TECHNOLOGY CO LTD SUBJECT

4Q2012

Y-SHAPE PEG NHS ESTER, MW 40000 (NON-STERILE BULK FORM) AS MANUFACTURED IN TIANJIN, CHINA AZATHIOPRINE USP AS MANUFACTURED IN MUMBAI, INDIA OXYMORPHONE HCL, USP AS MANUFACTURED IN WEST DEPTFORD, NJ ALLOPURINOL (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA FENOFIBRATE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA CILOSTAZOL (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA TRAMADOL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA WARFARIN SODIUM CLATHRATE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA BIMATOPROST DRUG SUBSTANCE AS MANUFACTURED IN TAKAOKA, TOYAMA, JAPAN RALOXIFENE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ADCOTE 548E AND COREACTANT F AS MANUFACTURED IN RINGWOOD, IL 700355 NATURAL AND ARTIFICIAL ORANGE FLAVOR AS MANUFACTURED IN COMMERCE, CA EMPTY HARD CAPSULES FROM HYDROXYPROPYLMETHYLCELLULOSE (HYPROMELLOSE) AS MANUFACTURED IN GREENWOOD, SC QUETIAPINE FUMARATE AS MANUFACTURED IN ZHEJIANG PROVINCE, R.P. CHINA KETOTIFEN AS MANUFACTURED IN FRAZIONE MAIRANO, ITALY VALACYCLOVIR HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA SODIUM BICARBONATE (STERILE) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA MPEP (MEROPENEM INTERMEDIATE) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA FLUOROMISONIDAZOLE F 18 INJECTION AS MANUFACTURED IN DUBLIN, OHIO CHENODEOXYCHOLIC ACID AS MANUFACTURED IN BERGAMO, ITALY KETOROLAC TROMETHAMINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA AMIODARONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA METFORMIN HYDROCHLORIDE EP. PB. IP. USP AS MANUFACTURED IN PUNE, INDIA 110017-A WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN PURELL PE 2420 F AS MANUFACTURED IN WESSELING, GERMANY CILASTATIN SODIUM (STERILE) (ESUB) AS MANUFACTURED IN MAHARASHATRA, INDIA SODIUM CARBONATE (STERILE) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA REBAMIPIDE AS MANUFACTURED IN JIANGXI PROVINCE, CHINA PHENYLEPHRINE TANNATE AS MANUFACTURED IN GUJARAT, INDIA MONTELUKAST SODIUM AS MANUFACTURED IN TAOYUAN, TAIWAN

Page 655

4Q2012EXCEL DMF# 21703 21704 21705 A 21706 21707 A 21708 A 21709 A 21710 A 21711 21712 A 21713 21714 21715 21716 A 21717 I 21718 21719 21720 21721 A 21722 21723 21724 A 21725 A 21726 A 21727 A 21728 A 21729 21730 A 21731 A IV 6/17/2008 KERRY INGREDIENTS AND FLAVOURS A IV IV 6/17/2008 6/17/2008 KERRY INGREDIENTS AND FLAVOURS KERRY INGREDIENTS AND FLAVOURS IV 6/17/2008 KERRY INGREDIENTS AND FLAVOURS III 6/17/2008 RELIANCE INDUSTRIES LTD II 3/17/2008 THERMAX LTD CHEMICAL DIV II 3/26/2008 A A II III III 6/10/2008 5/26/2008 6/13/2008 A A A III II II II 6/2/2008 5/19/2008 6/20/2008 6/18/2008 RITE SYSTEMS INC HARIKA DRUGS PRIVATE LTD SHASUN PHARMACEUTICALS LTD ZHEJIANG SHENGHUA BIOK BIOLOGY CO LTD DELAVAU LLC NUOVA OMPI SRL EQUISTAR CHEMICALS LP SUB LYONDELLBASELL THERMAX LTD CHEMICAL DIV II 6/6/2008 A A A II II II II 6/10/2008 6/13/2008 5/12/2008 6/6/2008 SICHUAN XIELI PHARMACEUTICAL CO LTD CHEMSPEC API TIANJIN TASLY GROUP CO LTD AMRI RENSSELAER INC SUB ALBANY MOLECULAR RESEARCH INC QILU PHARMACEUTICAL CO LTD A II II 6/3/2008 5/28/2008 II 7/31/2008 II 7/31/2008 II 6/19/2008 I II II 6/17/2008 7/25/2008 STATUS Type SUBMIT DATE A A II II II 6/16/2008 6/13/2008 7/23/2008 HOLDER FORMOSA LABORATORIES INC POLYPEPTIDE LABORATORIES INC ORCHID CHEMICALS AND PHARMACEUTICALS LTD RANBAXY LABORATORIES LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD SIBRA PHARMACEUTICALS LTD AN ARCH ENTERPRISE ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD SUBJECT BENZONATATE AS MANUFACTURED IN TAOYUAN, TAIWAN

4Q2012

OCTREOTIDE ACETATE BY GRANULATION AS MANUFACTURED IN TORRANCE, CA IMIPENEM (STERILE) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA EMTRICITABINE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA IMIPENEM + CILASTATIN SODIUM (STERILE BULK) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA EFAVIRENZ AS MANUFACTURED IN ANDHRA PRADESH, INDIA MEROPENEM + SODIUM CARBONATE (STERILE BULK) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA MEROPENEM (STERILE) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA SUMATRIPTAN SUCCINATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP AS MANUFACTURED IN MAHARASHTRA IRINOTECAN HCL AS MANUFACTUREDIN SICHUAN, CHINA BIS (3, 5-DIBROMOSALICYL) FUMARATE (DBSF) AS MANUFACTURED IN FAIRFIELD, NJ ESZOPICLONE AS MANUFACTURED IN TIANJIN, CHINA RACEPINEPHRINE HYDROCHLORIDE, USP DRUG SUBSTANCE, AS MANUFACTURED IN RENSSELAER , NY TERBINAFINE HYDROCHLORIDE (NON STERILE, API) AS MANUFACTURED IN SHANDONG PROVINCE, PEOPLE'S REPUBLIC OF CHINA WHITE, LQC-W2433-1, AS MANUFACTURED IN WEST CHICAGO, IL CHLORPHENIRAMINE TANNATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CYCLOSERINE AS MANUFACTURED IN CUDDALORE, INDIA PLEUROMUTILIN AS MANUFACTURED IN DEQING, ZHEJIANG, P.R. CHINA G-0181-API GRAN CC 765/MH 158-MCN-API AS MANUFACTURED IN PHILADELPHIA, PA E-Z-FILL PRODUCTS AS MANUFACTURED IN PIOMBINO DESE (PD), ITALY PRO-FAX ULTRA SC973 AS MANUFACTURED IN PASADENA, TXANDWEST LAKE, LA TULSION 345 (CALCIUM POLYSTYRENE SULPHONATE BP) AS MANUFACTURED IN MAHARASHTRA, INDIA TULSION 412 CHL (CHOLESTYRAMINE RESIN USP) AS MANUFACTURED IN MAHARASHTRA, INDIA POLYPROPYLENE (PP), H200MA, AS MANUFACTURED IN JAMNAGAR (GUJARAT), INDIA NATURAL/ARTIFICIAL BUBBLE GUM FLAVOR 0011638 AS MANUFACTURED INCINCINNATI, OH ARTIFICIAL COTTON CANDY FLAVOR 0011640 AS MANUFACTURED IN CINCINNATI, OH NATURAL/ARTIFICIAL BUBBLE GUM FLAVOR 0011639 AS MANUFACTURED IN CINCINNATI, OH NATURAL/ARTIFICIAL CHERRY BERRY TYPE FLAVOR 0014700 AS MANUFACTUREDIN CINCINNATI, OH

Page 656

4Q2012EXCEL DMF# 21732 21733 21734 21735 21736 21737 21738 A 21739 21740 21741 A 21742 21743 21744 A 21745 21746 A 21747 A 21748 21749 A 21750 21751 21752 21753 A 21754 I 21755 21756 21757 21758 21759 A 21760 21761 A 21762 21763 21764 A A A II II II 7/3/2008 9/30/2008 9/30/2008 NV ORGANON CIPLA LTD CIPLA LTD NANDROLONE DECANOATE AS MANUFACTURED IN OSS, THE NETHERLANDS A IV II 6/30/2008 7/3/2008 A A A A II II II II II 6/23/2008 7/1/2008 6/5/2008 7/1/2008 6/30/2008 II 6/27/2008 ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD PHARMA MAR SA CAMBREX CHARLES CITY INC FIDIA FARMACEUTICI SPA RPG LIFE SCIENCES LTD IRBESARTAN AS MANUFACTURED IN ZHEJIANG, CHINA TRABECTEDIN AS MANUFACTURED IN MADRID, SPAIN NICOTINE RESINATE, 20% AS MANUFACTURED IN CAMBREX CITY, IA TAMOXIFEN CITRATE AS MANUFACTURED IN MULAZZANO (LO), ITALY MERCAPTOPURINE USP AS MANUFACTURED IN MUMBAI, INDIA A A A II II II II 6/27/2008 7/18/2008 7/21/2008 7/19/2008 EDMOND PHARMA SUN PHARMACEUTICAL INDUSTRIES LTD SUN PHARMACEUTICAL INDUSTRIES LTD SUN PHARMACEUTICAL INDUSTRIES LTD A V II 6/24/2008 7/1/2008 COGNATE BIOSERVICES INC TEVA PHARMACEUTICAL INDUSTRIES LTD II 6/27/2008 A II II 6/30/2008 6/6/2008 RELIABLE BIOPHARMACEUTICAL CORP LIANYUNGANG JARI PHARMACEUTICAL CO LTD ZACH SYSTEM SPA A A V II III 6/27/2008 6/27/2008 6/30/2008 NOVARTIS PHARMACEUTICALS CORP WANBURY LTD BD MEDICAL PHARMACEUTICAL SYSTEMS A A II II II 6/25/2008 6/28/2008 6/24/2008 AVANTI POLAR LIPIDS INC MACLEODS PHARMACEUTICALS LTD MALLINCKRODT INC STATUS Type SUBMIT DATE A A A A A A II II IV III II V II 6/14/2008 6/27/2008 6/25/2008 7/2/2008 6/26/2008 6/26/2008 6/25/2008 HOLDER CTX LIFE SCIENCES PVT LTD STERLING SRL CIBA CORP SHRIJI POLYMERS INDIA LTD TORRENT PHARMACEUTICALS LTD ACS DOBFAR SPA AVANTI POLAR LIPIDS INC SUBJECT METOPROLOL SUCCINATE USP AS MANUFACTURED IN GUJARAT, INDIA DROSPIRENONE AS MANUFACTURED IN PERUGIA, ITALY IRGASURF HL560AS MANUFACTURED IN OBERNBURG, GERMANY POLYPROPYLENE CLOSURES (ESUB) AS MANUFACTURED IN UJJAIN, INDIA

4Q2012

RABEPRAZOLE SODIUM DRUG SUBSTANCE AS MANUFACTURED IN GUJARAT, INDIA VIALE ADDETTA PLANT - SMART PAK PLANT 1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DSPC) AS MANUFACTURED IN ALABASTER, AL DICETYL PHOSPHATE AS MANUFACTURED IN ALABASTER, AL INDOMETHACIN DRUG SUBSTANCE AS MANUFACTURED IN IN GUJARAT, INDIA COMPAP 90 (ACETAMINOPHEN USP 90% ANHYDROUS BASIS) (ESUB) AS MANUFACTURED IN GREENVILLE, ILLINOIS DRUG SUBSTANCE MANUFACTURING AT NOVARTIS BPO HUNINGUE (ESUB) LEVETIRACETAM AS MANUFACTURED IN MAHARASHTRA, INDIA BD UNIJECT PREFILLABLE INJECTION SYSTEM AS MANUFACTURED BY BD MEDICAL SYSTEM PTE, LTD IN SINGAPORE CHLOROTHIAZIDE, USP AS MANUFACTURED IN ST.LOUIS, MO IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN LIANYUNGANG CITY LEVETIRACETAM AS MANUFACTURED IN TAMIL NADU , INDIAFORZACH SYSTEM S P A FOR ZACH SYSTEM S P A CONTRACT MANUFACTURING FACILITIES PALONOSETRON HCL AS MANUFACTURED IN CZECH REPUBLIC FOR TEVA PHARMACEUTICAL INDUSTRIES LTD TULOBUTEROL BASE AS MANUFACTURED IN PADERMO DUGNANO (MI), ITALY QUINAPRIL HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA DULOXETINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA ROSIGLITAZONE MALEATE ANHYDROUS (ESUB) AS MANUFACTURED IN GUJARAT, INDIA

ZHEJIANG HISUN PHARMACEUTICAL CO LTD CAPREOMYCIN SULFATE CONCENTRATEAS MANUFACTURED IN TAIZHOU CITY, ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF CHINA SYMRISE INC 992890 ARTIFICIAL GRAPE FLAVOR 605935 AS MANUFACTURED IN TETERBORO, NJ SHANGHAI AJINOMOTO AMINO ACID CO LTD L-LEUCINE AS MANUFACTURED IN SHANGHAI, CHINA

LAMIVUDINE (PROCESS 3) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA LAMIVUDINE (PROCESS 2) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA

Page 657

4Q2012EXCEL DMF# 21765 A 21766 21767 A 21768 21769 21770 21771 21772 21773 21774 21775 21776 21777 21778 21779 21780 A 21781 A 21782 A 21783 A 21784 21785 21786 21787 A 21788 21789 21790 21791 A 21792 A 21793 21794 I 21795 21796 21797 A A A II II III 7/9/2008 7/9/2008 7/3/2008 C II II 7/14/2008 7/14/2008 CADILA HEALTHCARE LTD ZHEJIANG HISOAR PHARMACEUTICAL CO LTD CHUANNAN BRANCH COVALENT LABORATORIES PRIVATE LTD PROCOS SPA MICRODYNE PLASTICS INC III 7/4/2008 RELIANCE INDUSTRIES LTD A A A II II II II 7/10/2008 7/10/2008 6/24/2008 7/11/2008 A A A IV III II II 7/11/2008 7/9/2008 7/11/2008 6/18/2008 CAPSUGEL TOYO INK MFG CO LTD NATCO PHARMA LTD QILU ANTIBIOTICS PHARMACEUTICAL CO LTD NIPPON RIKA CO LTD NIPPON RIKA CO LTD INKE SA CRYSTAL PHARMA SAU IV 6/25/2008 FMC CORP FMC BIOPOLYMER DIV II 6/26/2008 ZHEJIANG SANHE PHARMACHEM CO LTD II 7/8/2008 A I A A A A A A A A A A II II III III III II II II III II III II II 7/2/2008 6/18/2008 7/3/2008 7/4/2008 7/4/2008 7/3/2008 6/30/2008 7/8/2008 6/30/2008 6/27/2008 7/1/2008 7/8/2008 5/28/2008 SIEGFRIED LTD FIS FABBRICA ITALIANA SINTETICI SPA BESPAK DIV CONSORT MEDICAL PLC RELIANCE INDUSTRIES LTD RELIANCE INDUSTRIES LTD PKC PHARMACEUTICALS INC DOLDER AG HOVIONE FARMACIENCIA SA MATRIX PACKAGING INC JOINT STOCK CO GRINDEKS NEX PERFORMANCE FILMS VASUDHA PHARMA CHEM LTD ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD DR REDDYS LABORATORIES LTD A III II 6/1/2008 6/27/2008 STATUS Type SUBMIT DATE II 6/26/2008 HOLDER LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTD JAMNADAS INDUSTRIES AUROBINDO PHARMA LTD SUBJECT

4Q2012

AMIFOSTINE TRIHYDRATE, NON-STERILE BULK AS MANUFACTURED IN JIANGSU PROVINCE, CHINA ALUMINUM FLIP OFF SEALS AS MANUFACTURED IN GUJARAT, INDIA DULOXETINE HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FLUOXETINE HYDROCHLORIDE AS MANUFACTURED IN ZOFINGEN, SWITZERLAND FIS1174 AS MANUFACTURED IN VICENZA, ITALY BK851 GSK DOSE COUNTER AS MANUFACTURED IN NORFOLK, ENGLAND RELENE F46003 AS MANUFACTURED IN SURAT (GUJARAT), INDIA RELENE 19010 AS MANUFACTURED IN SURAT (GUJRAT), INDIA RESINIFERATOXIN AS MANUFACTURED IN WOBURN, MA FLUOROURACIL AS MANUFACTURED IN, GERMANY FOR DOLDER AG 05ST03P AS MANUFACTURED IN LOURES, PORTUGAL PACKAGING MATERIALAS MANUFACTURED IN CHATSWORTH, CA OXYTOCIN, USP DRUG SUBSTANCE AS MANUFACTURED IN RIGA, LATVIA GRADE NXSLC70E AS MANUFACTURED IN RHINELANDER, WI CYCLOBENZAPRINE HCL AS MANUFACTURED IN HYDERABAD, INDIA IRBESARTAN AS MANUFACTURED IN ZHEJIANG, CHINA RIVASTIGMINE HYDROGEN TARTRATE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA MONOALDEHYDE (3-[2-(7-CHLORO-QUINOLIN-2-YL)-VINYL]-BENZALDEHYDE) AS MANUFACTURED IN ZHEJIANG, CHINA AVICEL HFE MICROCRYSTALLINE CELLULOSE AND MANNITOL AS MANUFACTURED IN NEWARK, DE VCAPS/VCAPS PLUS AS MANUFACTURED IN KANAGAWA PREFECTURE, JAPAN GRAVURE INK LAMISTAR SERIES AS MANUFACTURED IN TOKYO, JAPAN ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA 7-AMINO CEPHALOSPORANIC ACID (7-ACA) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA L-TYROSINE DRUG SUBSTANCE AS MANUFACTURED IN TOCHIGI, JAPAN ACETYLCYSTEINE DRUG SUBSTANCE AS MANUFACTURED IN TOCHIGI, JAPAN GRANISETRON BASE AS MANUFACTURED IN CASTELLBISBAL (BARCELONA), SPAIN PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN BEOCILLO (VALLADOLID), SPAIN POLYPROPYLENE (PP), GRADE: REPOL H200MK AS MANUFACTURED IN HAZIRA (GUJRAT), INDIA OMEPRAZOLE USP (FORM-B) AS MANUFACTURED IN GUJARAT, INDIA NIFELINE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA CEFUROXIME ACID AS MANUFACTURED IN ANDHRA PRADESH, INDIA PIVAGABINE AS MANUFACTURED IN CAMERI (NO), ITALY 950CC 45-400 JAR AS MANUFACTURED IN COLTON, CA

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4Q2012EXCEL DMF# 21798 21799 A 21800 21801 A 21802 A 21803 21804 21805 21806 21807 21808 A 21809 A 21810 21811 21812 21813 21814 21815 21816 21817 A 21818 A 21819 A 21820 21821 21822 21823 A 21824 21825 21826 21827 21828 21829 A 21830 A II 7/28/2008 A A A C A II III II II II III 7/28/2008 7/25/2008 7/28/2008 7/28/2008 7/10/2008 7/22/2008 I A A II II II III 7/17/2008 7/23/2008 7/24/2008 7/9/2008 MALLINCKRODT INC CAMBREX CHARLES CITY INC NEWCHEM SPA SENXING PHARMACEUTICAL CONSUMABLE BEIJING LTD SHASUN PHARMACEUTICALS LTD POLIMERI EUROPA SPA MENADIONA SL TEVA PHARMACEUTICAL INDUSTRIES LTD LAKE CHEMICALS PRIVATE LTD HYDRO ALUMINIUM ROLLED PRODUCTS GMBH ICROM SPA II 7/18/2008 APOTEX PHARMACHEM INC II 7/10/2008 HTI TECHNOLOGIES A A A A A I A IV III III III III II II IV 7/11/2008 7/16/2008 7/16/2008 7/16/2008 7/16/2008 7/18/2008 7/18/2008 7/23/2008 II 6/18/2008 A N A A A II II II II 7/15/2008 7/28/2008 7/14/2008 7/16/2008 II 7/17/2008 HOVIONE FARMACIENCIA SA NOT AN ASSIGNED NUMBER CSPC OUYI PHARMACEUTICAL CO LTD PHF SA FIDIA FARMACEUTICI SPA CHEMWERTH INC TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN HEBEI, CHINA THALIDOMIDE (ESUB) AS MANUFACTURED IN OLAINE, LATVIA ACAMPROSATE CALCIUM AS MANUFACTURED IN MULAZZANO (LO), ITALY II 7/17/2008 A II II 6/30/2008 7/15/2008 ALEMBIC PHARMACEUTICALS LTD CHONGQING SHENGHUAXI PHARMACEUTICAL CO LTD AVANTI POLAR LIPIDS INC STATUS Type SUBMIT DATE A II III 7/8/2008 6/25/2008 HOLDER CELSUS LABORATORIES INC PROENFAR SA SUBJECT ENOXAPARIN SODIUM AS MANUFACTURED IN CINCINNATI, OHIO

4Q2012

LDPE CONTAINERS FOR LIQUID OPHTHALMIC PRODUCTS REFERENCES 037E, 040E, CAP 140T, AND DROPTAINER 126S AS MANUFACTURED IN BOGOTA, COLOMBIA RIVASTIGMINE TARTRATE AS MANUFACTURED IN GUJARAT, INDIA DULOXETINE HCL AS MANUFACTURED IN CHONGQING, CHINA 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE-N-(BIOTINYL) (SODIUM SALT) (16:0 BIOTINYL PE) AS MANUFACTURED IN ALABASTER, AL TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN LOURES, PORTUGAL

TACROLIMUS, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN FUJIAN PROVINCE, CHINA FOR CHEMWERTH INC SHANDONG KEYUAN PHARMACEUTICAL CO DILUTED ISOSORBIDE MONONITRATE (DRUG SUBSTANCE, NON-STERILE) AS LTD MANUFACTURED IN SHANDONG PROVINCE, CHINA MASON CHEMICAL CO MACAT LB AS MANUFACTURED IN ARLINGTON HEIGHTS, IL RELIANCE INDUSTRIES LTD RELIANCE INDUSTRIES LTD RELIANCE INDUSTRIES LTD RELIANCE INDUSTRIES LTD SANOFI AVENTIS US LLC ORPEGEN PHARMA PURAC BIOCHEM BV POLYETHYLENE (PE), GRADE: 22FA002 AS MANUFACTURED IN GUJARAT, INDIA POLYETHYLENE (PE), GRADE: 24FS040 AS MANUFACTURED IN GUJARAT, INDIA POLYETHYLENE (PE), GRADE: 1005FY20 AS MANUFACTURED IN GUJARAT, INDIA POLYETHYLENE (PE), GRADE:16MA400 AS MANUFACTURED IN GUJARAT, INDIA EPLIVANSERIN HEMIFUMARATE AS MANUFACTURED IN ARAMON, FRANCE TLN-232 DRUG SUBSTANCE AS MANUFACTURED IN HEIDELBERG, GERMANY PURASORB POLYMERS AS MANUFACTURED IN GORINCHEM, THE NETHERLANDS FOR PURAC BIOMATERIALS BUSINES UNIT OF PURAC HYDROXYAPATITE COATINGS WITH PURE TITANIUM BOND COAT AS MANUFACTURED IN DECINES, FRANCE RISEDRONATE SODIUM HEMIPENTAHYDRATE AS MANUFACTUREDIN ONTARIO, CANADA 6-BETA-NALTREXOL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ST LOUIS, MO SUFENTANIL AS MANUFACTURED IN CHARLES CITY, IA PREDNISOLONE SODIUM PHOSPHATE AS MANUFACTURED IN VERONA, ITALY RUBBER STOPPER AS MANUFACTURED IN BEIJING, P.R. CHINA VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN CUDDALORE, INDIA FLEXIRENE MS 20 AS MANUFACTURED IN DUNKERQUE (FRANCE) QUETIAPINE FUMARATE AS MANUFACTURED IN BARCELONA, SPAIN DULOXETINE HCL AS MANUFACTURED IN BEER SHEVA, ISRAEL ALPRAZOLAM AS MANUFACTURED IN BANGALORE, KARNATAKA, INDIA HARP 506/1 AND 506/2 DRUG PACKAGING MATERIALS AS MANUFACTURED IN GREVENBROICH, GERMANY EPINASTINE HYDROCHLORIDE AS MANUFACTURED IN CONCOREZZO (MILAN), ITALY

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4Q2012EXCEL DMF# 21831 21832 21833 21834 21835 A 21836 21837 A 21838 I 21839 21840 A 21841 C 21842 A 21843 21844 A 21845 A 21846 21847 A 21848 21849 21850 21851 21852 21853 21854 21855 A 21856 A 21857 21858 21859 21860 A 21861 A II 7/25/2008 SAVIOR LIFETEC CORP A A A II II II II 8/1/2008 7/29/2008 8/5/2008 7/24/2008 III 7/24/2008 A A A A A A A II III II II II II IV III 7/30/2008 7/31/2008 8/1/2008 8/1/2008 7/31/2008 8/4/2008 7/30/2008 7/24/2008 TAIYO NIPPON SANSO CORP SABIC PETROCHEMICALS BV TEVA PHARMACEUTICAL INDUSTRIES LTD TRIFARMA SPA ROLABO OUTSOURCING SL GLENMARK GENERICS LTD NECTAR LIFESCIENCES LTD SHANDONG PHARMACEUTICAL GLASS CO LTD SHANDONG PHARMACEUTICAL GLASS CO LTD MEDICHEM MANUFACTURING MALTA LTD BIOCON LTD MYLAN LABORATORIES LTD WATER-18O AS MANUFACTURED IN CHIBA, JAPAN SABIC LDPE PCG80 AS MANUFACTURED IN GELEEN, THE NETHERLANDS ATORVASTATIN CALCIUM AS MANUFACTURED IN PETAH TIQVA, ISRAEL A IV IV 8/1/2008 8/1/2008 SYMRISE GBMH CO KG SYMRISE GBMH CO KG II 7/30/2008 AUROBINDO PHARMA LTD A IV II 7/23/2008 9/29/2008 II 7/9/2008 ZHEJIANG ANGLIKANG PHARMACEUTICAL CO LTD COGNIS GMBH H LUNDBECK AS II 7/31/2008 CRYSTAL PHARMA SAU I II III 5/30/2008 6/27/2008 SYNTHESIA AS AMPACET CORP II 7/30/2008 RANBAXY LABORATORIES LTD A II II 7/29/2008 7/28/2008 STATUS Type SUBMIT DATE A A A A III III II II II 7/28/2008 7/28/2008 7/30/2008 7/29/2008 7/24/2008 HOLDER KB SEIREN LTD KB SEIREN LTD SIGNA SA DE CV ISOCHEM SAS BAXTER PHARMACEUTICALS SOLUTIONS LLC MEDICHEM MANUFACTURING MALTA LTD ESTEVE QUIMICA SA SUBJECT H20N AS MANUFACTURED IN SHIGA PREFECTURE, JAPAN H20N-TU22 AS MANUFACTURED IN SHIGA PREFECTURE, JAPAN DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN TOLUCA, MEXICO NEFOPAM HYDROCHLORIDE AS MANUFACTURED IN PARIS, FRANCE

4Q2012

0.9% SODIUM CHLORIDE DILUENT, USP AS MANUFACTURED IN BLOOMINGTON, IN MED-200448/M AS MANUFACTURED IN HAL FAR, MALTA LEVETIRACETAM INJECTABLE GRADE/NON-STERILE AS MANUFACTURED IN BANYERES DEL PENEDES (TARRAGONA), SPAIN DULOXETINE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA ERGOCALCIFEROL AS MANUFACTURED IN SEMTIN, CZECH REPUBLIC AMPACET 19258-A- BLACK COP MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN HYDROCORTISONE BUTYRATE, MICRONIZED AS MANUFACTURED IN BOECILLO (VALLADOLID), SPAIN CEFALEXIN MONOHYDRATE (NON-STERILE, BULK FORM) AS MANUFACTURED IN SHENGZHOU, ZHEJIANG, PEOPLE'S REPUBLIC OF CHINA MONOMULS 90-L 12 AS MANUFACTURED IN DUESSELDORF, GERMANY LU AA24530 HYDROBROMIDE (ESUB) AS MANUFACTURED IN NYKOEBING SJ., DENMARK; BALERNA, SWITZERLAND; VALBY, DENMARK VALSARTAN USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FRUIT PUNCH FLAVOUR SD 204264 AS MANUFACTURED IN HOLZMINDEN, GERMANY NATURAL PEPPERMINT FLAVOR 290017 AS MANUFACTURED IN HOLZMINDEN, GERMANY

EPINASTINE HYDROCHLORIDE AS MANUFACTURED IN CERIANO LAGHETTO (MI), ITALY DOLASETRON MESYLATE AS MANUFACTURED IN ZARAGOZA, SPAIN ESZOPICLONE AS MANUFACTURED IN GUJARAT STATE, INDIA MENTHOL USP AS MANUFACTURED IN MOHALI (PUNJAB), INDIA BOROSILICATE GLASS (USP TYPE I) BARRELS FOR INJECTABLES FOR PREFILLED SYRINGES AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA BOROSILICATE GLASS (USP TYPE I) CYLINDERS FOR PEN-INJECTORS FOR MEDICAL USE AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA MED-201570/M AS MANUFACTURED IN HAL FAR, MALTA ATORVASTATIN CALCIUM AMORPHOUS AS MANUFACTURED IN BANGALORE, INDIA SALMETEROL XINAFOATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

CENTAUR PHARMACEUTICALS PRIVATE LTD DIAZEPAM USP AS MANUFACTURED IN MAHARASHTRA, INDIA MEROPENEM AND SODIUM CARBONATE (STERILE BULK) AS MANUFACTURED IN TAIWAN, R.O.C.

Page 660

4Q2012EXCEL DMF# 21862 21863 21864 21865 21866 21867 A 21868 21869 21870 21871 A 21872 A 21873 21874 21875 21876 21877 A 21878 21879 21880 21881 21882 A 21883 21884 21885 21886 21887 A 21888 21889 21890 21891 I 21892 21893 21894 A 21895 A II 8/8/2008 FIDIA FARMACEUTICI SPA A A II II II 8/18/2008 8/14/2008 8/20/2008 A A A III III III II 8/6/2008 8/15/2008 8/1/2008 8/12/2008 3M INDUSTRIAL ADHESIVES TAPE DIV 3M INDUSTRIAL ADHESIVES TAPE DIV SOLVIN SA TIANJIN PACIFIC CHEMICAL AND PHARMACEUTICAL CO LTD MSN PHARMACHEM PVT LTD UNIMARK REMEDIES LTD SANDOZ INDUSTRIAL PRODUCTS SPA PB009150 AS MANUFACTURED IN MEDINA, OH FP036002 AS MANUFACTURED IN MEDINA, OH DIOFAN A-740 AS MANUFACTURED IN TAVAUX, FRANCE A A A A II II III II II 8/13/2008 7/30/2008 7/7/2008 8/14/2008 8/5/2008 APICORE LLC POLYDRUG LABORATORIES PVT LTD STYROLUTION GMBH PHARMAZELL INDIA PRIVATE LTD FIS FABBRICA ITALIANA SINTETICI SPA A A C A II II II III IV 8/14/2008 8/12/2008 8/14/2008 8/1/2008 8/15/2008 BASIC PHARMA LIFE SCIENCE PVT LTD CORAL DRUGS PVT LTD FORMOSA LABORATORIES INC POLYCINE GMBH HENKEL CORP A A A A IV III III II II 8/11/2008 7/21/2008 7/21/2008 10/31/2008 8/12/2008 III 7/30/2008 GERRESHEIMER PLASTICOS SAO PAULO LTDA FONA INTERNATIONAL INC YONWOO CORP YONWOO CORP ABBVIE INC ALKERMES GAINESVILLE LLC A A A II II II IV 7/5/2008 8/8/2008 7/25/2008 7/28/2008 ISOCHEM NOVARTIS PHARMACEUTICALS CORP KAKEN PHARMACEUTICAL CO LTD DOW CORNING CORP STATUS Type SUBMIT DATE A A A A A II II II II II III 8/6/2008 8/4/2008 8/5/2008 9/26/2008 8/7/2008 7/23/2008 HOLDER SEQUENT SCIENTIFIC LTD EXCELLA GMBH IWAKI SEIYAKU CO LTD WATSON PHARMA PRIVATE LTD AARTI INDUSTRIES LTD AMPACET CORP SUBJECT METHOXSALEN USP AS MANUFACTURED IN KARNATAKA, INDIA BICALUTAMIDE MILLED Z (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY CETIRIZINE HYDROCHLORIDE AS MANUFACTURED IN SHIZUOKA, JAPAN

4Q2012

METOPROLOL TARTRATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA RANOLAZINE AS MANUFACTURED IN MAHARASHTRA, INDIA AMPACET 172954 LIME GREEN POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN BUFLOMEDIL HYDROCHLORIDE AS MANUFACTURED IN PARIS, FRANCE SMT487 ACETATE (EDOTREOTIDE) AS MANUFACTURED IN BASEL, SWITZERLAND KP-103/B AS MANUFACTURED IN YAMAGATA, JAPAN SILASTIC 7-6840 BIOMEDICAL GRADE LIQUID SILICONE RUBBER AS MANUFACTURED IN HEMLOCK, MI BOTTLES AS MANUFACTURED IN EMBU SP, BRAZIL 827.014 NAT CINNAMON FLAVOR (WONF) AS MANUFACTURED IN GENEVA, IL AS30-J/PP AND AS50-J/PPAS MANUFACTURED IN INCHEON, KOREA AS30/50-J/PP JAR AS MANUFACTURED IN INCHEON, KOREA NIACIN CORE TABLET INTERMEDIATE (ESUB) AS MANUFACTURED IN PUERTO RICO NAPRELAN (NAPROXEN SODIUM) CONTROLLED-RELEASE TABLETS, 375MG, 500MG, 750MG AS MANUFACTURED IN WESTMEATH, IRELAND CHLORHEXIDINE GLUCONATE AS MANUFACTURED IN ANKLESHWAR, GUJARAT, INDIA FLUTICASONE PROPIONATE AS MANUFACTURED IN HARYANA, INDIA PARICALCITOL AS MANUFACTURED IN TAOYUAN, TAIWAN APP107 TUBE AS MANUFACTURED IN SCHIFFWEILER, GERMANY DURO-TAK 87-613A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY, NC ISOSULFAN BLUE (ESUB) AS MANUFACTURED IN SOMERSET, NJ METOPROLOL SUCCINATE AS MANUFACTURED IN MAHARASHTRA, INDIA LURAN HD-20 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY L-CYSTINE AS MANUFACTURED IN CHENNAI, INDIA NITROFURANTOIN MONOHYDRATE (CODE 1042) AS MANUFACTURED IN VICENZA (ITALY)

METFORMIN HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN TIANJIN, CHINA ATORVASTATIN CALCIUM (FORM-I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA MONTELUKAST SODIUM (NI) AS MANUFACTURED IN VALSAD, GUJARAT, INDIA MYCOPHENOLIC ACID, DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN ROVERETO (TRENTO), ITALY FLUOXETINE HCL EP/USP AS MANUFACTURED IN GARBAGNATE MILANESE (MI), ITALY

Page 661

4Q2012EXCEL DMF# 21896 A 21897 21898 21899 A 21900 21901 21902 A 21903 21904 21905 A 21906 A 21907 21908 21909 21910 21911 A 21912 A 21913 21914 A 21915 21916 21917 21918 A 21919 21920 A 21921 21922 A 21923 21924 21925 A 21926 A II 8/25/2008 NUTRA SPECIALITIES PRIVATE LTD A A II II II 8/29/2008 8/29/2008 8/25/2008 A II IV 9/2/2008 8/29/2008 DR REDDYS LABORATORIES LTD CYCLOLAB CYCLODEXTRIN R AND D LABORATORY LTD WOCKHARDT LTD AVECIA BIOTECHNOLOGY INC NUTRA SPECIALITIES PRIVATE LTD A II II 8/27/2008 9/2/2008 ELDER PHARMACEUTICALS LTD MARTEK BIOSCIENCES CORP A A A II III II II 8/27/2008 8/19/2008 8/29/2008 8/29/2008 C II II 8/28/2008 10/18/2008 II 8/28/2008 A A I A II III II II II 8/21/2008 8/14/2008 8/11/2008 8/27/2008 8/27/2008 CONCORD BIOTECH LTD RICON COLORS INC INDOCO REMEDIES LTD HETERO DRUGS LTD II 7/30/2008 ONO PHARMACEUTICAL CO LTD A A IV IV III 8/20/2008 8/20/2008 8/21/2008 A A II II II 9/27/2008 9/28/2008 8/21/2008 SUN PHARMACEUTICAL INDUSTRIES LTD SUN PHARMACEUTICAL INDUSTRIES LTD VITALIFE LABORATORIES DIV ARCH PHARMALABS LTD MASTERTASTE SPA MASTERTASTE SPA NYPRO INC A A IV III II 8/11/2008 8/11/2008 10/25/2008 STATUS Type SUBMIT DATE II 8/13/2008 HOLDER ZHEJIANG HISOAR PHARMACEUTICAL CO LTD MASTERTASTE SPA AMPACET CORP SUN PHARMACEUTICAL INDUSTRIES LTD SUBJECT

4Q2012

CLINDAMYCIN PALMITATE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, CHINA 58.4108.UL PHA ORANGE FLAVOUR AS MANUFACTURED IN TORINO, ITALY 612249-PT WHITE PET MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA TAMSULOSIN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA ANASTROZOLE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA STAVUDINE USP AS MANUFACTURED IN HARYANA, INDIA 30109.1 DRYCELL CITRON FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY 20.4562.4P PHA ORANGE FLAVOUR AS MANUFACTURED IN TORINO, ITALY METERED DOSE INHALER, CONTAINER CLOSURE FOR: PRESS AND BREATH CAPPED ACTUATOR AS MANUFACTURED IN BRAY, COUNTY DUBLIN, IRELAND PROSTAGLANDIN E1 AS MANUFACTURED IN HYOGO, JAPAN . FOR ONO PHARMACEUTICAL MYCOPHENOLATE SODIUM AS MANUFACTURED IN AHMEDABAD, INDIA GREEN TINT, CPT-G4366-1 AS MANUFACTURED IN WEST CHICAGO, IL CIPROFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN RAIGAD, INDIA DORZOLAMIDE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

CALYX CHEMICALS AND PHARMACEUTICALS LOSARTAN POTASSIUM USP AS MANUFACTURED IN MAHARASHTRA, INDIA LTD APOTEX PHARMACHEM INC PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN BRANTFORD, ONTARIO, CANADA TEVA PHARMACEUTICAL INDUSTRIES LTD EPTIFIBATIDE AS MANUFACTURED IN NETANYA, ISRAEL ORCHID CHEMICALS AND PHARMACEUTICALS LTD KAMUD DRUGS PVT LTD AMPACET CORP LAURUS LABS PRIVATE LIMITED LAURUS LABS PRIVATE LTD LOSARTAN POTASSIUM (NON-STERILE BULK API) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA TRAMADOL HYDROCHLORIDE BP AS MANUFACTURED IN MAHARASHTRA, INDIA 682240-PT AMBER PET MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN CISPLATIN USP DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CARBOPLATIN USP DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CLARITHROMYCIN FORM II AS MANUFACTURED IN MAHARASHTRA STATE, INDIA DOCOSAHEXAENOIC ACID ACTIVE SINGLE CELL OIL (DHASCO) 55% AS MANUFACTURED IN KINGSTREE, SC AND WINCHESTER, KY CELECOXIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA BETA-CYCLODEXTRIN-SULFOBUTYLETHER DERIVATIVE AS MANUFACTURED IN BUDAPEST, HUNGARY DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA DPC 1528 (OLIGONUCLEOTIDE ARM), API, AS MANUFACTURED IN MILFORD, MA WARFARIN SODIUM USP (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA WARFARIN SODIUM USP (CLATHRATE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

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4Q2012EXCEL DMF# 21927 21928 21929 21930 A 21931 21932 A 21933 21934 A 21935 21936 A 21937 A 21938 A 21939 A 21940 21941 21942 21943 21944 A 21945 A 21946 21947 21948 A 21949 A 21950 A 21951 A 21952 21953 21954 21955 A 21956 A III 9/5/2008 A A I II II II II 9/5/2008 9/5/2008 10/1/2008 9/5/2008 FORMOSA LABORATORIES INC DK PHARMA CHEM PVT LTD CIPLA LTD II 9/1/2008 ALP PHARM BEIJING CO LTD II 9/1/2008 ALP PHARM BEIJING CO LTD II 9/1/2008 A I II II II 3/10/2008 9/8/2008 9/1/2008 III 9/5/2008 A A A A V II II II II 9/2/2008 9/4/2008 9/1/2008 9/1/2008 9/8/2008 II 9/5/2008 II 10/18/2008 II 9/20/2008 ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG AZBIL BIOVIGILANT INC POLYDRUG LABORATORIES PVT LTD ALP PHARM BEIJING CO LTD ALP PHARM BEIJING CO LTD ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO LTD BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG RN LABORATORIES PVT LTD RANBAXY LABORATORIES LTD SICHUAN SANCHINE SUNNYHOPE PHARMACEUTICAL CO LTD ALP PHARM BEIJING CO LTD A II II 9/5/2008 9/26/2008 CADILA HEALTHCARE LTD RA CHEM PHARMA LTD A III II 8/31/2008 9/2/2008 A II II 9/4/2008 8/25/2008 TEVA PHARMACEUTICAL INDUSTRIES LTD HARBIN PHARMACEUTICAL GROUP CO LTD GENERAL PHARMACEUTICAL FACTORY FUJIMORI KOGYO CO LTD AUROBINDO PHARMA LTD STATUS Type SUBMIT DATE I A A II II II II 11/19/2008 8/29/2008 9/1/2008 10/23/2008 HOLDER CIPLA LTD CARDINAL HEALTH 414 LLC SYNBIAS PHARMA LTD ACCORD HEALTHCARE INC SUBJECT IMIQUIMOD (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA SODIUM FLUORIDE F18 INJECTION AS MANUFACTURED IN DUBLIN, OH VINORELBINE TARTRATE AS MANUFACTURED IN DONETSK, UKRAINE

4Q2012

DOCETAXEL TRIHYDRATE API AS MANUFACTURED IN CHARLES CITY, IA FOR BIOXEL PHARMA INC OLMESARTAN AS MANUFACTURED IN BEER SHEVA, ISRAEL 6 AMINOPENCILLANIC ACID AS MANUFACTURED IN NANGANG, HARBIN FILMBYNA**E-5511 BD AS MANUFACTURED IN SHIZUOKA PREF., JAPAN GALANTAMINE HYDROBROMIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA CLONIDINE AS MANUFACTURED IN GUJARAT, INDIA VANILLYLAMINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ARIPIPRAZOLE (NON-STERILE BULK API) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ROPINIROLE HYDROCHLORIDE (NON-STERILE BULK API) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA TIOTROPIUM BROMIDE MONOHYDRATE AS MANUFACTURED IN INGELHEIM AM RHEIN, GERMANY IMD-A 300 AS MANUFACTURED IN TUCSON, AZ METOPROLOL TARTRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA 4-AA/AOSA AS MANUFACTURED IN BEIJING, CHINA CALCIPOTRIENE (CALCIPOTRIOL) AS MANUFACTURED IN BEIJING, CHINA MIFEPRISTONE AS MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF CHINA PLASTIC CONTAINER FOR RESPIMAT AS MANUFACTURED IN INGELHEIM AM RHEIN, GERMANY CHLORHEXIDINE GLUCONATE 20% SOLUTION AS MANUFACTURED IN GUJARAT, INDIA OLANZAPINE DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA MELOXICAM USP (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING, CHINA ALPRAZOLAM USP (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING, CHINA DALTEPARIN SODIUM (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING, CHINA AMLODIPINE BESYLATE (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING, CHINA MYCOPHENOLIC ACID AS MANUFACTURED IN TAOYUAN, TAIWAN. HYDRALAZINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA TORSEMIDE USP (ESUB) AS MANUFACTUREDIN MAHARASHTRA, INDIA

PIERRE FABRE MEDICAMENT PRODUCTION VINFLUNINE INJECTION AS MANUFACTURED IN GAILLAC CEDEX, FRANCE FOR PIERRE 2 FABRE MEDICAMENT PRODUCTION - AQUITAINE PHARM INTERNATIONAL KUNSTSTOFFWERK KREMSMUNSTER GMBH PP28 CHILD RESISTANT TAMPER-EVIDENT SCREW CAPS WITH FILLED DESICCANTINSERT AS MANUFACTURED IN KREMSUMUNSTER, AUSTRIA Page 663

4Q2012EXCEL DMF# 21957 21958 21959 21960 21961 A 21962 21963 21964 21965 A 21966 21967 21968 A 21969 21970 A 21971 21972 A 21973 A 21974 A 21975 21976 21977 21978 21979 21980 21981 21982 A 21983 A 21984 21985 A 21986 21987 21988 21989 I A A A II II II II 1/29/2009 12/5/2008 11/10/2009 11/26/2008 A II II 9/16/2008 9/15/2008 CSPC OUYI PHARMACEUTICAL CO LTD VITALIFE LABORATORIES DIV ARCH PHARMALABS LTD JUBILANT ORGANOSYS LTD JUBILANT LIFE SCIENCES LTD JUBILANT LIFE SCIENCES LTD JUBILANT LIFE SCIENCES LTD II 9/17/2008 A A A A A A A II II III II II II II II 10/6/2008 9/13/2008 9/11/2008 9/16/2008 10/13/2008 9/17/2008 9/8/2008 9/10/2008 IPCA LABORATORIES LTD DR REDDYS LABORATORIES LTD REXAM PHARMA GMBH SMS PHARMACEUTICALS LTD WATSON PHARMA PRIVATE LTD APOTEX PHARMACHEM INC FARCHEMIA SRL QILU ANTIBIOTICS PHARMACEUTICAL CO LTD EMCURE PHARMACEUTICALS LTD II 12/30/2008 CHEMWERTH INC III 8/12/2008 ESS DEE ALUMINIUM LTD A II II 9/10/2008 9/11/2008 A II II 9/11/2008 9/12/2008 MYLAN LABORATORIES LTD A A II II II 12/3/2008 3/26/2009 9/5/2008 CIPLA LTD CIPLA LTD NANJING LANYA CHEMICAL CO LTD A A A II II II III 9/9/2008 9/5/2008 9/10/2008 9/5/2008 CADILA PHARMACEUTICALS LTD DISHMAN NETHERLANDS BV LAURUS LABS PRIVATE LTD FORMOSA PLASTICS CORP USA STATUS Type SUBMIT DATE A A A A III II II II II 8/29/2008 9/5/2008 8/15/2008 8/26/2008 9/4/2008 HOLDER MONDI COATING ZELTWEG GMBH MYLAN LABORATORIES LTD AMERICAN PEPTIDE CO CADILA PHARMACEUTICALS LTD ANQIU LUAN PHARMACEUTICAL CO LTD SUBJECT

4Q2012

FLEXIBLE PACKAGING MATERIALS AS MANUFACTURED IN ZELTWEG, AUSTRIA LANTHANUM CARBONATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA COSYNTROPIN TFA SALT PEPTIDE AS MANUFACTURED IN VISTA, CA ATORVASTATIN CALCIUM AS MANUFACTURED IN GUJARAT, INDIA ACETAMINOPHEN, DC 90 S AS MANUFACTURED IN SHANDONG PROVINCE, PEOPLE'S REPUBLIC OF CHINA NATEGLINIDE FORM B AS MANUFACTURED IN GUJARAT, INDIA CALCIFEDIOL AS MANUFACTURED IN WEESP, THE NETHERLANDS EFAVIRENZ DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FORMOLON 690F PVC RESIN AS MANUFACTURED IN POINT COMFORT, TX AND BATON ROUGE, LA RANOLAZINE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ATAZANAVIR SULPHATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA MAGNESIUM LACTATE DIHYDRATE AS MANUFACTURED IN GAOYOU, CHINA FOR NANJING LANYA CHEMICAL CO LTD EFAVIRENZ USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

CALYX CHEMICALS AND PHARMACEUTICALS VALPROIC ACID AS MANUFACTURED IN THANE, (MAHARASHTRA), INDIA LTD LUPIN LTD FENOFIBRATE-SLS MIXTURE AS MANUFACTURED IN MAHARASHTRA, INDIA FARMABIOS S P A BECLOMETASONE DIPROPIONATE MONOHYDRATE MICRONIZED AS MANUFACTURED IN GROPELLO CAIROLI (PV), ITALY NON TOXIC FOOD/PHARMA GRADE ALU ALU LAMINATE, NON TOXIC FOOD/PHARMA GRADE CHILD RESISTANT (CR) FOIL, NON TOXIC FOOD/PHARMA GRADE TROPICALISED LAMINATE AS MANUFACTURED IN NANI DAMAN (U.T.), INDIA EPINASTINE HCL (ESUB) AS MANUFACTURED BY SICHUAN CREDIT CHEMWERTH PHARMACEUTICAL CO., LTD. IN SICHUAN PROVINCE, P.R. CHINA FOR CHEMWERTH, INC INDAPAMIDE USP (ESUB) AS MANUFACUTRED IN MADHYA PRADESH, INDIA ESZOPICLONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA MIRENA INSERTER AS MANUFACTURED IN NEUENBURG, GERMANY NICOTINE POLACRILEX USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA METOPROLOL SUCCINATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA OLANZAPINE AS MANUFACTURED IN BRANTFORD ON, CANADA OLSALAZINE SODIUM AS MANUFACTURED IN TREVIGLIO, ITALY CEFAZOLIN SODIUM, STERILE BULK AS MANUFACTURED IN JINAN, CHINA SODIUM FERRIC GLUCONATE COMPLEX (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA INDOMETHACIN AS MANUFACTURED IN SHIJIAZHUANG, CHINA ATORVASTATIN CALCIUM CRYSTALLINE AS MANUFACTURED IN HARYANA, INDIA ESOMEPRAZOLE SODIUM (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA MECLIZINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN KARNATACA, INDIA LANSOPRAZOLE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA GALANTAMINE HYDROBROMIDE (ESUB) AS MANUFACTURED IN KARNATACA,Page 664 INDIA

4Q2012EXCEL DMF# 21990 21991 A 21992 A 21993 21994 21995 21996 21997 A 21998 A 21999 A 22000 A 22001 A 22002 A 22003 A 22004 A 22005 A 22006 A 22007 A 22008 A 22009 A 22010 A 22011 A 22012 A 22013 A 22014 22015 A A II II 8/28/2008 9/19/2008 JIANGSU ZW PHARMACEUTICALS CO LTD JIANGSU HENGRUI MEDICINE CO LTD III 9/17/2008 TEKNOR APEX CO III 9/17/2008 TEKNOR APEX CO III 9/16/2008 TEKNOR APEX CO III 9/16/2008 TEKNOR APEX CO III 9/16/2008 TEKNOR APEX CO III 9/16/2008 TEKNOR APEX CO III 9/16/2008 TEKNOR APEX CO III 9/16/2008 TEKNOR APEX CO III 9/16/2008 TEKNOR APEX CO III 9/16/2008 TEKNOR APEX CO III 9/16/2008 TEKNOR APEX CO III 9/16/2008 TEKNOR APEX CO III 9/16/2008 TEKNOR APEX CO III 9/16/2008 TEKNOR APEX CO III 9/16/2008 TEKNOR APEX CO III 9/16/2008 TEKNOR APEX CO A A A A II II V V III 9/15/2008 9/16/2008 9/19/2008 9/2/2008 9/16/2008 NEWCHEM SPA UNITED LABORATORIES CHENGDU CO LTD GE HEALTHCARE INC AZBIL BIOVIGILANT INC TEKNOR APEX CO III 9/1/2008 STATUS Type SUBMIT DATE A II II 9/26/2008 7/17/2008 HOLDER JUBILANT LIFE SCIENCES LTD AJINOMOTO INTERAMERICANA IND E COM LTDA ANSA PRINTPACK PVT LTD SUBJECT PINAVERIUM BROMIDE (ESUB) AS MANUFACTURED IN KARNATACA, INDIA L-ISOLEUCINE AS MANUFACTURED IN LIMERIA, BRAZIL

4Q2012

PRINTED CARTONS AND PRINTED LABELS AND LEAFLETS AS MANUFACTURED IN THANE, MAHARASHTRA, INDIA MOMETASONE FUROATE MICRONIZED AS MANUFACTURED IN VERONA, ITALY 6-AMINO-PENICILLANIC ACID (6-APA) AS MANUFACTURED IN SICHUAN, P.R. CHINA FASTLAB PET SYNTHESIZER AS MANUFACTURED IN LONCIN, BELGIUM IMD-A-350 AS MANUFACTURED IN TUCSON, AZ MEDALIST MD-100 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-105 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-110 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-115 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-120 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-125 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-130 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-135 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-140 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-145 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-150 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-155 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-160 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-165 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-170 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-175 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-180 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO CAPECITABINE AS MANUFACTURED IN JIANGSU, P.R. CHINA GABAPENTIN, USP, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU, CHINA Page 665

4Q2012EXCEL DMF# 22016 A 22017 A 22018 22019 A 22020 22021 22022 22023 A 22024 A 22025 A 22026 A 22027 22028 22029 A 22030 A 22031 22032 22033 22034 A 22035 22036 22037 22038 22039 I 22040 A 22041 A 22042 22043 22044 22045 22046 A I A A A II II II II II 10/6/2008 9/30/2008 9/30/2008 9/19/2008 10/2/2008 AARTI DRUGS LTD CADILA HEALTHCARE LTD DR REDDYS LABORATORIES LTD CTX LIFE SCIENCES PVT LTD FORMOSA LABORATORIES INC II 9/24/2008 CADILA HEALTHCARE LTD II 9/29/2008 MALLINCKRODT INC A I A A IV II II III II 9/1/2008 9/23/2008 9/25/2008 9/29/2008 9/28/2008 A A A II II II II 10/1/2008 9/25/2008 9/23/2008 9/18/2008 II 10/1/2008 HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD DR REDDYS LABORATORIES LTD MYLAN LABORATORIES LTD CHEMWERTH INC SPECIALTY ENZYMES AND BIOCHEMICALS CO CRODA INC QILU TIANHE PHARMACEUTICAL CO LTD DR REDDYS LABORATORIES LTD CAPS AND CANS QILU TIANHE PHARMACEUTICAL CO LTD POLYMYXIN B SULFATE AS MANUFACTURED IN HANGZHOU CHINA A A II II II 9/24/2008 9/30/2008 9/24/2008 CADILA HEALTHCARE LTD RELIABLE BIOPHARMACEUTICAL CORP IBA MOLECULAR II 9/26/2008 II 9/22/2008 BD BIOSCIENCES ADVANCED BIOPROCESSING BIAL PORTELA AND CA SA II 9/24/2008 A A A II II II II 11/12/2008 9/23/2008 9/19/2008 9/22/2008 JANSSEN PHARMACEUTICA, N.V. DR REDDYS LABORATORIES LTD NOVUS FINE CHEMICALS LLC DISHMAN PHARMACEUTICALS AND CHEMICALS LTD DR REDDYS LABORATORIES LTD A II II 9/19/2008 10/22/2008 II 9/19/2008 CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO LTD MICROBIOPHARM JAPAN CO LTD JANSSEN PHARMACEUTICA NV STATUS Type SUBMIT DATE III 9/19/2008 HOLDER WEST PHARMACEUTICAL SERVICES INC SUBJECT

4Q2012

DAIKYO CRYSTAL ZENITH RU SYRINGE SYSTEM AS MANUFACTURED IN JERSEY SHORE, PA; MONTGOMERY, PA; AND SAN DIEGO, CA CHLOROTHIAZIDE AS MANUFACTURED IN INNER MONGOLIA, CHINA EPIRUBICIN HYDROCHLORIDE AS MANUFACTURED IN KUMAMOTO, JAPAN CARISBAMAT (RWJ 333369) (ESUB) AS MANUFACTURED IN GEEL, BELGIUM AND SCHAFFHAUSEN, SWITZERLAND TRABECTEDIN (R279741) (ESUB) AS MANUFACTURED IN BEERSE, BELGIUM DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN CARLSTADT, NJ ROPIVACAINE HYDROCHLORIDE ANHYDROUS AS MANUFACTURED IN AHMEDABAD, GUJARAT, INDIA CARVEDILOL PHOSPHATE (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA BD CELL MAB MEDIUM BASE W/O PHENYL RED AS MANUFACTURED IN SPARKS, MD AND DENVER, PA FOR BD BIOSCIENCES - ADVANCED BIOPROCESSING ESLICARBAZEPINE ACETATE DRUG SUBSTANCE AS MANUFACTURED IN DOTTIKON, SWITZERLAND FOR BIAL PORTELA CA SA HYDROCHLOTHIAZIDE AS MANUFACTURED IN GUJARAT, INDIA COSYNTROPIN ACETATE AS MANUFACTURED IN ST. LOUIS, MO SODIUM [18F] FLUORIDE ([18F]NAF) FOR INJECTION AS MANUFACTURED IN STERLING, VA

RABEPRAZOLE SODIUM (FORM-Y) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ZOFENOPRIL CALCIUM AS MANUFACTURED IN RAIGAD, MAHARASHTRA, INDIA TIAGABINE HYDROCHLORIDE USP AS MANUFACTURED IN SICHUAN CHINA LACTASE USP AS MANUFACTURED IN NASHIK INDIA FOR SPECIALTY ENZYMES AND BIOCHEMICALS CO CRODESTA SL 40E (SUCROSE COCOATE) AS MANUFACTURED IN MILL HALL PA ALPRAZOLAM USP (NON STERILE API) AS MANUFACTURED IN SHANDONG CHINA SILDENAFIL CITRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA PLASTIC BOTTLES AND CAPS AS MANUFACTURED IN BANGALORE, INDIA BUFLOMEDIL HYDROCHLORIDE (NON STERILE API) AS MANUFACTURED IN SHANDONG CHINA BENZPHETAMINE HYDROCHLORIDE CODE 9223 (ESUB) AS MANUFACTURED IN ST LOUIS, MO PIOGLITAZONE HYDROCHLORIDE ( ESUB) AS MANUFACTURED IN ANKLESHWAR, GUJARAT, INDIA HYDROXYZINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA CARVEDILOL (FORM II) AS MANUFACTURED IN ANKLESHWAR, GUJARAT, INDIA NICARDIPINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA XYLOMETAZOLINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA MYCOPHENOLATE MOFETIL AS MANUFACTURED IN TAOYUAN TAIWAN

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4Q2012EXCEL DMF# 22047 A 22048 A 22049 A 22050 A 22051 22052 22053 22054 22055 22056 A 22057 22058 22059 A 22060 A 22061 A 22062 A 22063 22064 22065 22066 A 22067 22068 22069 A 22070 22071 A 22072 A 22073 A 22074 A III 10/7/2008 II 8/5/2008 II 11/12/2008 A II II 9/30/2008 11/27/2008 ELDER PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD AMRAZ LTD A A III II II 9/24/2008 10/8/2008 10/8/2008 ROLLPRINT PACKAGING PRODUCTS INC WOCKHARDT LTD EMCURE PHARMACEUTICALS LTD A C A II II II III 10/7/2008 9/26/2008 10/5/2008 9/26/2008 EURAND INC ALEMBIC PHARMACEUTICALS LTD DIVIS LABORATORIES LTD COSTER USA INC EUR 1030 MICROCAPS AS MANUFACTURED IN VANDALIA, OH BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA KETOENAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA II 10/7/2008 II 10/6/2008 II 9/30/2008 A N II 10/6/2008 II 10/1/2008 A A A A A III III III II III III 9/26/2008 9/26/2008 9/26/2008 10/3/2008 9/30/2008 9/19/2008 DYNIC USA DYNIC USA DYNIC USA AARTI INDUSTRIES LTD POLYONE CORP GERRESHEIMER PLASTICOS SAO PAULO LTDA ALCHYMARS ICM SM PRIVATE LTD NOT AN ASSIGNED NUMBER MYLAN LABORATORIES LTD S2B THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN S2C THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN S10 THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN SALMETEROL XINAFOATE AS MANUFACTURED IN MAHARASHTRA INDIA CC10106574WE AMBER PET AS MANUFACTURED IN ELK GROVE VILLAGE, IL CLOSURES AS MANUFACTURED IN EMBU, SAO PAULO, BRAZIL ATOVAQUONE USP AS MANUFACTURED IN TAMILNADU, INDIA II 10/2/2008 NATCO PHARMA LTD III 9/30/2008 3M DRUG DELIVERY SYSTEMS II 10/1/2008 POLYCARBON INDUSTRIES INC STATUS Type SUBMIT DATE II 10/1/2008 HOLDER BACHEM AMERICAS INC SUBJECT

4Q2012

[N-TRANS-3-HEXENOYL] GRF (1-44), ACETATE (BULK) AS MANUFACTURED IN TORRANCE, CA SODIUM 4-PHENYLBUTYRATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN NEWBURYPORT, MA MOMETASONE & FORMOTEROL COMBINATION PRODUCT HFA SHORTENED BODY ACTUATOR AS MANUFACTURED IN DUBLIN, IRELAND FOR 3M DRUG DELIVERY SYSTEMS DIV LANTHANUM CARBONATE DIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

PROGUANIL HYDROCHLORIDE USP AS MANUFACTURED IN RAIGAD, MAHARASHTRA, INDIA CENTAUR PHARMACEUTICALS PRIVATE LTD OXAZEPAM USP AS MANUFACTURED IN MAHARASHTRA, INDIA CALYX CHEMICALS AND PHARMACEUTICALS ERYTHROMYCIN STEARATE AS MANUFACTURED IN MAHARASHTRA, INDIA LTD SYMBIOTEC PHARMALAB LTD BETAMETHASONE VALERATE, USP (MICRONIZED) AS MANUFACTURED IN INDORE, INDIA

BAG-ON-VALVE (BOV) COMPONENTS AND SYSTEMS AS MANUFACTURED BY COSTER USA, INC. AND COSTER TECHNOLGIE SPECIALI S.P.A. IN SOUTH ELGIN, IL AND CALCERANICA AL LOGO AND CALDONAZZO, ITALY RPP# 26-2203 AS MANUFACTURED IN ADDISON, IL OCTREOTIDE ACETATE AS MANUFACTURED IN MAHARASHTRA, INDIA SEVELAMER HYDROCHLORIDE (PROCESS I) AS MANUFACTURED IN MAHARASHTRA, INDIA TOLFENAMIC ACID AS MANUFACTURED IN MAHARASHTRA STATE, INDIA ESZOPICLONE (NON-STERILE BULK API) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA PANTOPRAZOLE SODIUM (NON-STERILE BULK API) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA LOSARTAN POTASSIUM (SYNTHESIS II) AS MANUFACTURED IN ZHEJIANG, CHINA 60 ML PLASTIC BOTTLE FOR CAPSULES/TABLETS PACKAGING AS MANUFACTURED IN ASHDOD, ISRAEL FOR AMRAZ LTD

Page 667

4Q2012EXCEL DMF# 22075 A 22076 A 22077 A 22078 A 22079 22080 22081 A 22082 22083 22084 A 22085 22086 A 22087 A 22088 22089 22090 22091 A 22092 22093 22094 22095 22096 22097 22098 A 22099 22100 22101 A 22102 A 22103 A 22104 22105 A A II II 10/15/2008 10/22/2008 LUNDBECK PHARMACEUTICALS ITALY SPA EMCURE PHARMACEUTICALS LTD II 10/17/2008 STI PHARMACEUTICALS LTD II 10/17/2008 LIPOID GMBH A A II II III 11/13/2008 11/7/2008 9/25/2008 CIPLA LTD KD-PHARMA BEXBACH GMBH AMPACET CORP A A A P A A II III III 11/20/2008 10/18/2008 10/10/2008 II II II 10/16/2008 10/8/2008 10/17/2008 MYLAN LABORATORIES LTD IND SWIFT LABORATORIES LTD EXCELLA GMBH *** PENDING FILING REVIEW *** FIS FABBRICA ITALIANA SINTETICI SPA SVAM PACKAGING INDUSTRIES PVT LTD AMPACET CORP PROGESTERONE (ESUB) AS MANUFACTURED IN VICENZA, ITALY SLITTED ALU-ALU FOIL AS MANUFACTURED IN NEW DELHI, INDIA A A A II II II IV 10/14/2008 9/29/2008 10/9/2008 10/15/2008 JOHNSON MATTHEY PHARMA SERVICES HUBEI HAOSUN PHARMACEUTICAL CO LTD BASF SE SEPPIC SA II 10/6/2008 A III II 10/3/2008 9/22/2008 AMPACET CORP ZHEJIANG HISOAR PHARMACEUTICAL CO LTD CHUANNAN BRANCH NECTAR LIFESCIENCES LTD A A II II III 10/1/2008 4/3/2008 10/2/2008 SIEGFRIED USA LLC AMISHI DRUGS AND CHEMICALS LTD AMPACET CORP A C II II II 10/8/2008 10/14/2008 9/29/2008 PROCOS SPA EVERLIGHT CHEMICAL INDUSTRIAL CORP ZACH SYSTEM SPA II 10/9/2008 CHEMPORT INC II 10/9/2008 CHEMPORT INC III 9/23/2008 AMPACET CORP STATUS Type SUBMIT DATE IV 10/10/2008 HOLDER SYMRISE INC SUBJECT

4Q2012

622065 NATURAL FLAVOR, GRAPE TYPE AS MANUFACTURED IN TETERBORO, NJ AND BRANCHBURG, NJ AMPACET 110070 BLUE WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; AND DERIDDER, LA EICOSAPENTAENOIC ACID, 90% ETHYL ESTER AS MANUFACTURED IN NAJU-SI, JEOLLANAM-DO, SOUTH KOREA DOCOSAHEXAENOIC ACID, 80% ETHYL ESTER AS MANUFACTURED IN NAJU-SI, JEOLLANAM-DO, SOUTH KOREA TROSPIUM CHLORIDE AS MANUFACTURED IN CAMERI (NO), ITALY BIMATOPROST AS MANUFACTURED IN TAOYUAN HSIEN, TAIWAN CLOPIDOGREL BISULFATE AS MANUFACTURED IN TAMIL NADU, INDIA FOR ZACH SYSTEM SPA HYDROMORPHONE HYDROCHLORIDE USP AS MANUFACTURED IN PENNSVILLE, NJ SILVER SULFADIAZINE USP AS MANUFACTURED IN GUJARAT, INDIA AMPACET 140417 ORANGE POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; AND DERIDDER, LA AMPACET 181086-K BEIGE 086 AS MANUFACTURED IN RAYONG, THAILAND DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA CEFUROXIME ACID (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN CHANDIGARH, INDIA TRAVOPROST (3031.H) AS MANUFACTURED IN DEVENS, MA GRANISETRON BASE AS MANUFACTURED IN EZHOU, HUBEI, CHINA ACITRETIN AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY MONTANIDE ISA 720 VG STERILE AS MANUFACTURED IN CASTRES, FRANCE FOR SEPPIC SA TOLMETIN SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA LETROZOLE USP AS MANUFACTURED IN PUNJAB, INDIA LANTHANUM CARBONATE AS MANUFACTURED IN FEUCHT, GERMANY

AMPACET PRODUCT 681751-PT AMBER PET MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; HEATH, OH; DERIDDER, LA; CARTERSVILLE, GA EXEMESTANE (ESUB) AS MANUFACTURED IN MAHARASHTRE, INDIA OMEGA-3 ACIDS ETHYL ESTER (ESUB) AS MANUFACTURED IN BEXBACH, GERMANY AMPACET PRODUC 682236-PT AMBER PET MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; HEATH, OH; DERIDDER, LA; CARTERSVILLE, GA LIPOID PURIFIED SOYBEAN OIL 700 (PH.EUR., USP)AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY SYNTHETIC CANNABIDIOL (CBD) AS MANUFACTURED IN HOLYWELL NORTH WALES, UNITED KINGDOM IMIPRAMINE PAMOATE (ESUB) AS MANUFACTURED IN PADOVA, ITALY FENOPROFEN CALCIUM AS MANUFACTURED IN MAHARASHTRE, INDIA

Page 668

4Q2012EXCEL DMF# 22106 A 22107 22108 22109 22110 A 22111 22112 22113 22114 22115 22116 22117 A 22118 A 22119 22120 22121 22122 A 22123 22124 22125 22126 22127 22128 22129 22130 22131 A 22132 22133 22134 22135 A 22136 22137 I 22138 22139 22140 A A A II III II 10/23/2008 10/24/2008 10/27/2008 C II III 10/31/2008 10/28/2008 FORMOSA LABORATORIES INC MAX WIEGAND GLASWARENFABRIK CRAILSHEIM EMCURE PHARMACEUTICALS LTD REXAM PHARMA SAS HETERO LABS LTD A A A II II II II 11/11/2008 11/21/2008 11/4/2008 7/6/2010 A A A P P A A A II II II II 11/27/2008 11/29/2008 1/5/2009 12/12/2008 II II II 11/18/2008 10/24/2008 8/19/2009 WATSON PHARMA PRIVATE LTD MEDICHEM MANUFACTURING MALTA LTD CIPLA LTD *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** SUN PHARMACEUTICAL INDUSTRIES LTD SUN PHARMACEUTICAL INDUSTRIES LTD SUN PHARMACEUTICAL INDUSTRIES LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD FARMAK AS USV LIMITED MYLAN LABORATORIES LTD STELLAR BIOTECHNOLOGIES INC PREGABALIN (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ESZOPICLONE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA A A A II II II III 11/6/2008 10/27/2008 10/27/2008 10/29/2008 PROPORTIONAL TECHNOLOGIES INC SAI LIFE SCIENCES LTD GLENMARK GENERICS LTD HOSPIRA INC II 10/23/2008 ALP PHARM BEIJING CO LTD A A A A A A II II II IV II II II 10/23/2008 10/23/2008 11/4/2008 10/17/2008 10/29/2008 10/21/2008 10/23/2008 MSN PHARMACHEM PVT LTD MSN PHARMACHEM PVT LTD USV LIMITED INDENA SPA ALEMBIC PHARMACEUTICALS LTD ALP PHARM BEIJING CO LTD PREGABALIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA A A A II III II II 10/22/2008 10/31/2008 10/24/2008 10/24/2008 GLENMARK GENERICS LTD ALMEGA PLASTICS INC USV LIMITED STATUS Type SUBMIT DATE II 10/17/2008 HOLDER CRODA EUROPE LTD SUBJECT

4Q2012

OMEGA-3-ACID ETHYL ESTERS AS MANUFACTURED IN STAFFORDSHIRE, UNITED KINGDOM RILUZOLE AS MANUFACTURED IN GUJARAT, INDIA LIQUID MEDICATION DISPENSERS (ESUB) AS MANUFACTURED IN NEW CASTLE, PA CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

ZHEJIANG HISUN PHARMACEUTICAL CO LTD ORLISTAT AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA SEVELAMER HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA IDN 5404 (THIOCOLCHICINE DERIVATIVE) AS MANUFACTURED IN SETTALA (MI), ITALY LOSARTAN POTASSIUM USP AS MANUFACTURED IN GUJARAT, INDIA ATORVASTATION CALCIUM (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN CHANGPING DISTRICT, BEIJING, P.R. CHINA CARISOPRODOL (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN SHANXI PROVINCE, P.R. CHINA FOR ALP PHARM BEIJING CO LTD KIT FOR RAPID PREPARATION OF 64CU-ATSM AS MANUFACTURED IN HOUSTON, TX DOXERCALCIFEROL AS MANUFACTURED IN HYDERABAD, ANDHRA PRADESH, INDIA ATOVAQUONE, USP AS MANUFACTURED IN BHARUCH, GUJARAT STATE, INDIA STANDARD MICROBIOLOGICAL METHODS FOR CONTRACT MANUFACTURED DRUG PRODUCT PACKAGED IN PVC FLEXIBLE CONTAINER AS MANUFACTURED IN AUSTIN, TX TELMISARTAN (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA MED-200380/M AS MANUFACTURED IN HAL FAR, MALTA ALOSETRON HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA

HENRY H OTTENS MANUFACTURING CO INC ARTIFICIAL RASPBERRY FLAVOR # 7557-A AS MANUFACTURED IN PHILADELPHIA, PA

DESMOPRESIN ACETATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA NARATRIPTAN HYDROCHLORIDE (NON-STERILE BULK API) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA WARFARIN SODIUM AS MANUFACTURED IN OLOMOUC, CZECH REPUBLIC ENTACAPONE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ATOVAQUONE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA SUBUNIT KEYHOLE LIMPET HEMOCYANIN (ESUB) AS MANUFACTURED IN LEXINGTON, KY FOR STELLAR BIOTECHNOLOGIES INC DOXERCALCIFEROL AS MANUFACTURED IN TAOYUAN, TAIWAN GLASS VIALS AS MANUFACTURED IN CRAILSHEIM, GERMANY MEFLOQUINE HYDROCHLORIDE USP AS MANUFACTURED IN PUNE, INDIA NASLAL SPRAY BOTTLES AS MANUFACTURED IN OFFRANVILLE, FRANCE CAPECITABINE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 669

4Q2012EXCEL DMF# 22141 A 22142 22143 A 22144 22145 A 22146 I 22147 I 22148 A 22149 22150 A 22151 22152 A 22153 A 22154 22155 22156 22157 22158 22159 22160 C 22161 A 22162 A 22163 22164 22165 22166 22167 22168 A 22169 A II 10/31/2008 EUTICALS SPA A A A A A II II II II II II 10/27/2008 11/3/2008 11/10/2008 10/29/2008 11/11/2008 10/27/2008 II 11/5/2008 VITALIFE LABORATORIES DIV ARCH PHARMALABS LTD ALP PHARM BEIJING CO LTD WOCKHARDT LTD MYLAN LABORATORIES LTD INDOCO REMEDIES LTD APOTEX PHARMACHEM INC ALP PHARM BEIJING CO LTD II 11/10/2008 SMS PHARMACEUTICALS LTD A A A A I A II II II II II II II 11/3/2008 11/13/2008 10/29/2008 10/27/2008 11/4/2008 11/3/2008 10/31/2008 SYMRISE INC SIEGFRIED LTD EXCELLA GMBH DIVIS LABORATORIES LTD CF PHARMA LTD SEQUENT SCIENTIFIC LTD TEVA PHARMACEUTICAL INDUSTRIES LTD III 11/4/2008 AMPACET CORP A II III 10/23/2008 11/3/2008 ALP PHARM BEIJING CO LTD GLENROY INC I II II 8/15/2008 10/23/2008 HUBEI XUNDA PHARMACEUTICAL CO LTD WANBURY LTD III 10/24/2008 III 10/13/2008 III 10/13/2008 BERRY PLASTICS CORP TAPES AND COATINGS DIV BERRY PLASTICS CORP TAPES AND COATINGS DIV SHANDONG PHARMACEUTICAL GLASS CO LTD A II II 10/27/2008 10/24/2008 SAFC INC ALP PHARM BEIJING CO LTD A II III 10/31/2008 10/23/2008 STATUS Type SUBMIT DATE II 11/3/2008 HOLDER SUBJECT

4Q2012

CHONGQING PHARMACEUTICAL RESEARCH PEMETREXED DISODIUM, (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED INSTITUTE CO LTD IN CHONGQING, CHINA TORRENT PHARMACEUTICALS LTD SILDENAFIL CITRATE AS MANUFATURED IN GUJARAT, INDIA 3M DRUG DELIVERY SYSTEMS 3M MEDICAL TAPE #9770 AS MANUFACTURED IN BROOKINGS, SD FOR 3M DRUG DELIVERY SYSTEMS SGD-1006 (SG6) AS MANUFACTURED IN MADISON, WI SERTRALINE HYDROCHLORIDE (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING, CHINA MS-H-MEDSHIELD 1108 AS MANUFACTURED IN HOMER, LA MS-H-MEDSHIELD 1008 AS MANUFACTURED IN HOMER, LA BOROSILICATE GLASS (USP TYPE I) BARRELS (WITH STAINLESS STEEL NEEDLE) FOR INJECTABLES FOR PREFILLED SYRINGES AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA FOR SHANDONG PHARMACEUTICAL GLASS CO LTD KETOPROFEN AS MANUFACTURED IN HUBEI PROVINCE, CHINA LOSARTAN POTASSIUM AS MANUFACTURED IN MAHARASHTRA, INDIA FOR WANBURY LTD LUTEIN (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING, CHINA GLENROY STRUCTURE NO. EFO 117-001 AS MANUFACTURED IN MENOMONEE FALLS, WI 112109-A WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; LATEXO, TX; CARTERSVILLE, GA; HEATH, OH; AND DERIDDER, LA MENTHOL, RAC AS MANUFACTURED IN GOOSE CREEK, SC NICOTINE POLACRILEX 20% AS MANUFACTURED IN ZOFINGEN, SWITZERLAND MYCOPHENOLATE SODIUM AS MANUFACTURED IN FEUCHT, GERMANY CAPECITABINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA BICALUTAMIDE ADSORBATE AS MANUFACTURED IN BUDAPEST, HUNGARY IMIQUIMOD AS MANUFACTURED IN MANGALORE, INDIA BORTEZOMIB AS MANUFACTURED IN OPAVA, CZECH REPUBLIC AND LERMA, MEXICO FOR TEVA PHARMACEUTICAL INDUSTRIES LTD. PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA NEVIRAPINE ANHYDROUS USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR VITALIFE LABORATORIES (DIV ARCH PHARMALABS LTD) EPO (RECOMBINANT HUMAN ERYTHROPOIETIN) AS MANUFACTURED IN BEIJING, CHINA ESZOPICLONE AS MANUFACTURED IN GUJARAT, INDIA (S)-PREGABALIN AS MANUFACTURED IN MAHARASHTRA, INDIA BRIMONIDINE TARTRATE AS MANUFACTURED IN RABALE, MNAVI MUMBAI, INDIA CLONAZEPAM AS MANUFACTURED IN A. P., INDIA FOR APOTEX PHARMACHEM INC ROSMARINIC ACID (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING, CHINA HYDRALAZINE HYDROCHLORIDE AS MANUFACTURED IN LODI, ITALY

Page 670

4Q2012EXCEL DMF# 22170 A 22171 A 22172 22173 C 22174 A 22175 A 22176 A 22177 A 22178 I 22179 I 22180 A 22181 22182 22183 22184 A 22185 22186 22187 A 22188 22189 A 22190 A 22191 22192 22193 22194 22195 A 22196 22197 A A II III 11/17/2008 11/3/2008 HETERO LABS LTD HINDALCO INDUSTRIES LTD A N P P III 11/14/2008 II 3/8/2010 II 11/4/2008 ORCHID CHEMICALS AND PHARMACEUTICALS LTD AKZONOBEL SALT AS NOT AN ASSIGNED NUMBER *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** PARTH FOILS P LTD A IV III 11/12/2008 11/14/2008 FONA INTERNATIONAL INC MINNESOTA RUBBER AND PLASTICS A A III III III 11/7/2008 11/3/2008 11/3/2008 AMERICHEM INC HINDALCO INDUSTRIES LTD HINDALCO INDUSTRIES LTD A A A II V II II 11/13/2008 10/24/2008 11/14/2008 11/17/2008 II 8/22/2008 ZHOUSHAN PUTO XINXING PHARMACHEM CO LTD HIKMA PHARMACEUTICALS ONCO THERAPIES LTD CADILA PHARMACEUTICALS LTD GLENMARK GENERICS LTD III 11/7/2008 AMPACET CORP III 11/7/2008 II 8/22/2008 II 8/22/2008 II 8/22/2008 ZHOUSHAN PUTO XINXING PHARMACHEM CO LTD ZHEJIANG ZHOUHUA ORGANISMS SCIENCE AND TECHNOLOGY DEVELOPMENT CO LTD ZHEJIANG ZHOUHUA ORGANISMS SCIENCE AND TECHNOLOGY DEVELOPMENT CO LTD AMPACET CORP II 11/12/2008 TEVA PHARMACEUTICAL INDUSTRIES LTD A II II 11/11/2008 11/12/2008 KUREHA CORP TEVA PHARMACEUTICAL INDUSTRIES LTD V 11/11/2008 AMGEN TECHNOLOGY IRELAND STATUS Type SUBMIT DATE III 11/5/2008 HOLDER CHROMA CORP SUBJECT

4Q2012

EC77592 50/1 TRANS AMBER COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, IL PRODUCTION MODULE 2 (PM2) (ESUB) ASEPTIC FACILITY LOCATED CO. DUBLIN, IRELAND PSK (KRESTIN) DRUG SUBSTANCE AS MANUFACTURED IN FUKUSHIMA, JAPAN SOLIFENACIN AS MANUFACTURED IN NETANYA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD FULVESTRANT AS MANUFACTURED IN LERMA, MEXICO FOR TEVA PHARMACEUTICAL INDUSTRIES LTD GLUCOSAMINE SULFATE POTASSIUM CHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA GLUCOSAMINE SULFATE POTASSIUM CHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA GLUCOSAMINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA 682432-PT AMBER PET MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; LATEXO, TX; CARTERSVILLE, GA; HEATH, OH; AND DERIDDER, LA 682433-PT AMBER PET MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; LATEXO, TX; CARTERSVILLE, GA; HEATH, OH; AND DERIDDER, LA GLUCOSAMINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA ONDANSETRON HYDROCHLORIDE, USP AS MANUFACTURED IN AMMAN, JORDAN STERILE MANUFACTURING FACILITY FOR ONCOLOGICAL PRODUCTS VALSARTAN AS MANUFACTURED IN GUJARAT, INDIA DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN BHARUCH, GUJARAT STATE, INDIA 46603 RED AS MANUFACTURED IN CUYAHOGA FALLS, OH ALUMINIUM STRIP FOIL (COATED/PRINTED) AS MANUFACTURED IN SILVASSA, INDIA ALUMINIUM BLISTER FOIL (BARE/COATED/PRINTED) AS MANUFACTURED IN SILVASSA, INDIA 805.245 N-C NAT BANANA FLAVOR (WONF) AS MANUFACTURED IN GENEVA, IL RUBBER ELASTOMERS FOR INSULIN APPLICATIONS AS MANUFACTURED IN MASON CITY, IA AND/OR WATERTOWN, SD MEROPENEM (NON-STERILE) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA SODIUM CHLORIDE AS MANUFACTURED IN MARIAGER DENMARK

FLEXIBLE PACKAGING MATERIALS AS MANUFACTURED UT OF DADRA NAGAR AND HAVELI, INDIA AND HIMACHAL PRADESH, INDIA. ABACAVIR SULFATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ALUMINIUM STRIP FOIL (BARE/LAMINATED/PRINTED) AS MANUFACTURED IN SILVASSA, INDIA

Page 671

4Q2012EXCEL DMF# 22198 C 22199 22200 22201 22202 22203 22204 A 22205 22206 A 22207 22208 A 22209 A 22210 22211 22212 22213 22214 A 22215 22216 A 22217 A 22218 22219 A 22220 A 22221 22222 A 22223 22224 22225 22226 22227 A 22228 22229 A A II II 11/24/2008 11/26/2008 A A A A II III II II II 11/24/2008 11/21/2008 11/21/2008 11/20/2008 11/14/2008 A II II 1/13/2009 11/24/2008 IPCA LABORATORIES LTD QINGDAO JIULONG BIOPHARMACEUTICAL CO LTD CHANGZHOU PHARMACEUTICAL FACTORY BD MEDICAL PHARMACEUTICAL SYSTEMS MSN PHARMACHEM PVT LTD NEWCHEM SPA III 11/25/2008 POLYONE CORP A II II 1/22/2009 10/1/2009 IPCA LABORATORIES LTD IPCA LABORATORIES LTD ARTESUNATE (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA II 2/23/2009 IPCA LABORATORIES LTD A II II 1/12/2009 2/23/2009 IPCA LABORATORIES LTD IPCA LABORATORIES LTD A A A A II II IV IV II 11/13/2008 11/5/2008 10/27/2008 10/27/2008 11/21/2008 II 11/17/2008 ACTAVIS PHARMA MANUFACTURING PRIVATE LTD SUPRIYA LIFESCIENCE LTD OLON SPA NUSIL TECHNOLOGY LLC NUSIL TECHNOLOGY LLC FRED HUTCHINSON CANCER RESCTR A II II 11/21/2008 11/19/2008 CATALENT ARGENTINA SAIC NOF CORP C II II 11/10/2008 11/21/2008 TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD A A A A C II II II III II II 10/23/2008 11/17/2008 11/20/2008 11/7/2008 11/14/2008 11/19/2008 OLON SPA EXCELLA GMBH HETERO DRUGS LTD RICON COLORS INC TEVA PHARMACEUTICAL INDUSTRIES LTD AUROBINDO PHARMA LTD STATUS Type SUBMIT DATE II 11/14/2008 HOLDER TEVA PHARMACEUTICAL INDUSTRIES LTD SUBJECT LATANOPROST AS MANUFACTURED IN BE'ER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN TORINO (TO), ITALY

4Q2012

CEVIMELINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY FELBAMATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA AMBER, CPT-B3220-1 AS MANUFACTURED IN WEST CHICAGO, IL ESZOPICLONE AS MANUFACTURED IN GUAYAMA, PUERTO RICO FAMCICLOVIR (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ZOLMITRIPTAN AS MANUFACTURED IN ZAGREB, CROATIA DARIFENACIN HBR AS MANUFACTURED IN BE'ER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD ADVIL LIQUI-GELS, 200 MG AS MANUFACTURED IN BUENOS AIRES, ARGENTINA HIGH PURITY EGG YOLK PHOSPHATIDYLCHOLINE (HP-EPC) AS MANUFACTURED IN HYOGO, JAPAN PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU, INDIA CHLORPHENIRAMINE MALEATE AS MANUFACTURED IN MAHARASHTRA, INDIA THIOCTIC ACID AS MANUFACTURED IN RODANO (MI), ITALY DDU-4630 SILICONE ELASTOMER AS MANUFACTURED IN CARPINTERIA, CA DDU-4340 SILICONE ELASTOMER AS MANUFACTURED IN CARPINTERIA, CA MANUFACTURE AND QUALITY CONTROL OF THE BC8-SA MONOCLONAL ANTIBODY CONJUGATE (BC8-SA) AS MANUFACTURED IN SEATTLE, WA WARFARIN SODIUM USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA AMODIAQUINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA ARTEMETHER (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA

Losartan Potassium USP (LB5 Process) (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA CC00014033WE 21E14048CMB OCEAN AS MANUFACTURED IN ELK GROVE VILLAGE, IL AND GLENDALE, AZ LUMEFANTRINE (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA HEPARIN SODIUM USP (ESUB) AS MANUFACTURED IN QINGDAO, SHANDONG, P.R. CHINA PREGABALIN AS MANUFACTURED IN JIANGSU PROVINCE, CHINA BD ACCUSPRAY(TM) NASAL SPRAY SYSTEM AS MANUFACTURED IN COLUMBUS, NE DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CLOBETASOL 17-PROPIONATE AS MANUFACTURED IN VERONA (VR), ITALY

ZHEJIANG HISUN PHARMACEUTICAL CO LTD MEVASTATIN, NON-STERILE, API AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA MOEHS IBERICA SL BUPIVACAINE HYDROCHLORIDE AS MANUFACTURED IN BARCELONA, SPAIN HETERO LABS LTD GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 672

4Q2012EXCEL DMF# 22230 22231 22232 A 22233 22234 22235 A 22236 22237 22238 A 22239 22240 22241 A 22242 22243 22244 A 22245 A 22246 22247 22248 22249 22250 22251 22252 22253 22254 22255 22256 22257 22258 22259 22260 22261 22262 22263 22264 22265 A P C N A A A A A A I A P A A P A A A A II II II II II 12/4/2008 12/3/2008 12/5/2008 12/4/2008 12/6/2008 II II 12/22/2008 1/8/2009 II IV III II II II II II 12/3/2008 11/24/2008 11/18/2008 12/4/2008 11/29/2008 11/20/2008 12/5/2008 11/28/2008 II 11/29/2008 II 12/1/2008 JOHNSON MATTHEY PHARMACEUTICAL MATERIALS *** PENDING FILING REVIEW *** UNIMARK REMEDIES LTD NOT AN ASSIGNED NUMBER EMCURE PHARMACEUTICALS LTD NUSIL TECHNOLOGY LLC UPM RAFLATAC INC APOTEX PHARMACHEM INC ALEMBIC PHARMACEUTICALS LTD ANTIBIOTICOS SPA KAKEN PHARMACEUTICAL CO LTD KAMUD DRUGS PVT LTD *** PENDING FILING REVIEW *** WATSON PHARMA PRIVATE LTD OLTA PHARMACEUTICALS CORP *** PENDING FILING REVIEW *** MUSTAFA NEVSAT ILAC SANAYII AS CHEMO IBERICA SA MADRID DR REDDYS LABORATORIES LTD MACLEODS PHARMACEUTICALS LTD AUROBINDO PHARMA LTD STERILE SULBACTAM SODIUM AS MANUFACTURED IN KOCAELI, TURKEY NABUMETONE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA LINDANE USP (ESUB) AS MANUFACTURED IN EAST DEKALB, MS RIVASTIGMINE TARTRATE AS MANUFACTURED IN MAHARASHTRA, INDIA DDU-310 SILICONE FLUID AS MANUFACTURED IN CARPINTERIA, CA RP51 ADHESIVE AS MANUFACTURED IN FLETCHER, NC RIVASTIGMINE TARTRATE AS MANUFACTURED IN BRANTFORD ON, CANADA HYDROCHLOROTHIAZIDE USP AS MANUFACTURED IN GUJARAT, INDIA TACROLIMUS MONOHYDRATE AS MANUFACTURED IN LEON SPAIN KP-413 DRUG SUBMSTANCE AS MANUFACTURED IN TOYAMA, JAPAN C A II III II 12/1/2008 11/26/2008 12/19/2008 A A II III V 12/9/2008 11/18/2008 11/4/2008 A A II II II 11/21/2008 12/2/2008 11/24/2008 A A II II II 12/1/2008 11/18/2008 11/21/2008 STATUS Type SUBMIT DATE A A II II II 12/1/2008 12/1/2008 11/25/2008 HOLDER SYMED LABS LTD HETERO LABS LTD PRIME EUROPEAN THERAPEUTICS SPA EUTICALS SPA CADILA HEALTHCARE LTD MACLEODS PHARMACEUTICALS LTD ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD NEWCHEM SPA GLENMARK GENERICS LTD SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTD USV LIMITED AMPACET CORP MICROTROL STERILISATION SERVICES PVT LTD TEVA PHARMACEUTICAL INDUSTRIES LTD AGI GLASPAC NORAMCO INC SUBJECT BRIMONIDINE TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ANASTROZOLE AS MANUFATURED IN ANDHRA PRADESH, INDIA ADENOSINE AS MANUFACTURED IN VARESE ITALY DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA REPAGLINIDE AS MANUFACTURED IN GUJARAT INDIA LEVETIRACETAM API AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA

4Q2012

FLUTICASONE PROPIONATE MICRONIZED AS MANUFACTURED IN VERONA ITALY ZOLMITRIPTAN AS MANUFACTURED IN GUJARAT INDIA SULFASALAZINE AS MANUFACTURED IN SHANGHAI PR CHINA LETROZOLE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA AMPACET 181907 K AMBER 907 AS MANUFACTURED IN RAYONG THAILAND GAMMA IRRADIATION STERILISATION TREATMENT FOR MEDICAL DEVICES AS MANUFACTURED IN BENGALOORU INDIA PREGABALIN AS MANUFACTURED IN BEER SHEVA ISRAEL GLASS BOTTLES USP TYPE III AS MANUFACTURED IN HYDERABAD INDIA METHYLPHENIDATE HYDROCHLORIDE (R042928) (ESUB) AS MANUFACTURED IN ATHENS, GA JOHNSON MATTHEY B1105 AS MANUFACTURED IN WEST DEPTFORD, NEW JERSEY

TIGECYCLINE TECHNICAL (ESUB) AS MANUFACTURED INGUJARAT, INDIA

KETAMINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

SEVELAMER CARBONATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA SOLIFENACIN SUCCINATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN GUJARAT, INDIA LEVOFLOXACIN (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA Page 673

4Q2012EXCEL DMF# 22266 22267 22268 22269 22270 22271 22272 22273 22274 22275 22276 22277 22278 22279 22280 22281 22282 22283 22284 22285 22286 22287 22288 A 22289 22290 A 22291 22292 22293 22294 A 22295 A 22296 A 22297 22298 A 22299 22300 22301 A A A II II II 12/10/2008 12/15/2008 12/9/2008 ALCHYMARS ICM SM PRIVATE LTD DR REDDYS LABORATORIES LTD CADILA PHARMACEUTICALS LTD A II IV 12/9/2008 12/12/2008 LUPIN LTD HENKEL AG AND CO KGAA II 11/21/2008 LAURUS LABS PRIVATE LIMITED II 12/4/2008 INDOCO REMEDIES LTD A A A III IV II III 12/10/2008 12/10/2008 12/9/2008 12/11/2008 TOWA KAKO CO LTD PREMIER SPECIALTIES INC LUPIN LTD HOSPIRA INC A II II 12/8/2008 12/8/2008 CAYMAN PHARMA SRO SHANGHAI DONGYUE BIOCHEM CO LTD STATUS Type SUBMIT DATE A A A A A A A A A A A A A A A A A I A A A A III III III III III III III III III III II II II II II III II II II II II V II 12/4/2008 12/4/2008 12/4/2008 12/4/2008 12/4/2008 12/4/2008 12/4/2008 12/4/2008 12/4/2008 12/4/2008 12/4/2008 12/2/2008 12/2/2008 12/2/2008 11/20/2008 12/8/2008 12/9/2008 12/9/2008 11/3/2008 10/17/2008 12/15/2008 12/10/2008 12/10/2008 HOLDER KAYGEE LOPAREX INDIA PVT LTD KAYGEE LOPAREX INDIA PVT LTD KAYGEE LOPAREX INDIA PVT LTD KAYGEE LOPAREX INDIA PVT LTD KAYGEE LOPAREX INDIA PVT LTD KAYGEE LOPAREX INDIA PVT LTD KAYGEE LOPAREX INDIA PVT LTD KAYGEE LOPAREX INDIA PVT LTD KAYGEE LOPAREX INDIA PVT LTD KAYGEE LOPAREX INDIA PVT LTD BACHEM SA ALP PHARM BEIJING CO LTD ALP PHARM BEIJING CO LTD ALP PHARM BEIJING CO LTD YUNG ZIP CHEMICAL IND CO LTD RELIANCE INDUSTRIES LTD APOTEX PHARMACHEM INC SANDOZ INDUSTRIAL PRODUCTS SPA FIDIA FARMACEUTICI SPA HUATAI BIOPHARM INC SYMED LABS LTD ACS DOBFAR SPA ACS DOBFAR SPA SUBJECT GRADE XL-TDP PET 12 AS MANUFACTURED IN SILVASSA, INDIA GRADE XL-TDP PET 23 AS MANUFACTURED IN SILVASSA, INDIA GRADE XL-TDP PET 30 AS MANUFACTURED IN SILVASSA, INDIA GRADE XL-TDP PET 36 AS MANUFACTURED IN SILVASSA, INDIA GRADE XL-TDP PET 75 AS MANUFACTURED IN SILVASSA, INDIA GRADE XL-TDP PET 50 AS MANUFACTURED IN SILVASSA, INDIA GRADE XL-TDP PET 100 AS MANUFACTURED IN SILVASSA, INDIA GRADE XL-TDP PET 125 AS MANUFACTURED IN SILVASSA, INDIA GRADE XL-TDP PET 175 AS MANUFACTURED IN SILVASSA, INDIA GRADE XL-TDP PET 250 AS MANUFACTURED IN SILVASSA, INDIA ZONISAMIDE AS MANUFACTURED IN VIONNAZ, SWITZERLAND TRANEXAMIC ACID AS MANUFACTURED IN BEIJING, CHINA LOTEPREDNOL ETABONATE AS MANUFACTURED IN BEIJING, CHINA ELOCALCITOL AS MANUFACTURED IN BEIJING, CHINA CLOPIDOGREL BISULFATE AS MANUFACTURED IN TAI CHUNG, TAIWAN RELENE 54GB012 AS MANUFACTURED IN DAHEJ, INDIA TIZANIDINE HYDROCHLORIDE AS MANUFACTURED IN KARNATAKA, INDIA SIMVASTATIN AS MANUFACTURED IN ROVERETO (TRENTO), ITALY

4Q2012

OMEGA-3-ACID ETHYL ESTERS AS MANUFACTURED IN MULAZZANO (LO), ITALY OMEGA-3-ACID ETHYL ESTERS 90 AS MANUFACTURED IN SICHUAN, CHINA LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA VIALE ADDETTA PLANT-CRYSTALLIZATION PLANT 2 STERILE VANCOMYCIN HYDROCHLORIDE USP, 100G AS MANUFACTURED IN COPENHAGEN S, DENMARK TRAVOPROST AS MANUFACTURED IN NERATOVICE, CZECH REPUBLIC DIPHENHYDRAMINE HCL USP AS MANUFACTURED IN QIDONG CITY JIANGSU PROVINCE, CHINA TOWA CLEAN FILM SERIES AS MANUFACTURED IN TIYODAKU TOKYO, JAPAN FLAVOR AND FRAGRANCE INFORMATION AS MANUFACTURED IN MIDDLESEX, NJ SEVELAMER CARBONATE AS MANUFACTURED IN MAHARASHTRA, INDIA STANDARD MICROBIOLOGICAL METHODS FOR CONTRACT MANUFACTURED DRUG PRODUCT PACKAGED IN CR3 FLEXIBLE CONTAINER AS MANUFACTURED IN ROCKY MOUNT, NC AND AUSTIN, TEXAS DICYCLOMINE HYDROCHLORIDE AS MANUFACTURED IN TALKUKA KHALAPUR, DISTRICT RAIGAD, INDIA IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ESZOPICLONE AS MANUFACTURED IN MAHARASHTRA, INDIA DURO-TAK 87-617A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURG, NC WARFARIN SODIUM USP AS MANUFACTURED IN TAMIL NADU, INDIA IBANDRONATE SODIUM (FORM-B) AS MANUFACTURED IN ANDHRA PRADESH, INDIA OLANZAPINE FORM-I AS MANUFACTURED IN GUJARAT, INDIA

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4Q2012EXCEL DMF# 22302 22303 22304 22305 22306 22307 22308 A 22309 22310 A 22311 22312 A 22313 A 22314 A 22315 A 22316 A 22317 A 22318 A 22319 22320 22321 A 22322 22323 22324 22325 22326 22327 22328 22329 22330 22331 22332 A A A A A A A A A A A II II II II III II II II II II II 12/16/2008 12/17/2008 12/19/2008 12/9/2008 12/15/2008 12/17/2008 12/20/2008 12/19/2008 12/17/2008 12/5/2008 12/18/2008 POLYPEPTIDE LABORATORIES INC CADILA HEALTHCARE LTD SCINOPHARM TAIWAN LTD LUPIN LTD COLORMATRIX CORP NECTAR LIFESCIENCES LTD FRESENIUS KABI AUSTRIA GMBH CAMBREX CHARLES CITY INC LUPIN LTD CSPC OUYI PHARMACEUTICAL CO LTD A A II II II 12/18/2008 12/1/2008 12/17/2008 FARMABIOS S P A SAFC INC KRKA DD NOVO MESTO II 12/17/2008 NOF CORP II 12/15/2008 DAISO CO LTD III 12/16/2008 DOW CHEMICAL CO IV 12/17/2008 SYMRISE INC III 12/15/2008 AMPACET CORP III 12/16/2008 HOSPIRA INC A II II 12/15/2008 5/12/2009 CHEMAGIS LTD CIPLA LTD A II II 12/11/2008 12/10/2008 RA CHEM PHARMA LTD IND SWIFT LABORATORIES LTD STATUS Type SUBMIT DATE A A A A A A III II III III III III II 12/15/2008 1/6/2009 12/15/2008 12/15/2008 12/8/2008 12/11/2008 12/12/2008 HOLDER ALTE REGO CORP FRESENIUS KABI ONCOLOGY LTD ALTE REGO CORP ALTE REGO CORP RELIANCE INDUSTRIES LTD AIRSEC SAS CHEMO IBERICA SA MADRID SUBJECT ARC API LINER CLEAR AS MANUFACTURED TORONTO, CANADA

4Q2012

TOPOTECAN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN WEST BENGAL, INDIA ARC API LINER BLACK AS MANUFACTURED TORONTO, CANADA ARC API LINER CLEAR NFPA99 2.0 AS MANUFACTURED IN TORONTO, CANADA RELENE 1020FA20 AS MANUFACTURED IN MAHARASHTRA, INDIA EQ-PAK SACHET AS MANUFACTURED IN ROMORANTIN, FRANCE TIANEPTINE SODIUM AS MANUFACTURED IN MADRID, SPAIN FOR CHEMO IBERICA SA MADRID MECLIZINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA ATORVASTATIN CALCIUM CRYSTALLINE (VER:01/ATE/1008/00) AS MANUFACTURED IN PUNJAB, INDIA GRANISETRON BASE AS MANUFACTURED IN SHEVA, ISRAEL DESLORATADINE FORM I: FORM II (89:11) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA STANDARD MICROBIOLOGICAL METHODS FOR CONTRACT MANUFACTURED DRUG PRODUCT PACKAGED IN TYPE I GLASS BOTTLES AS MANUFACTURED IN CLAYTON, NORTH CAROLINA AMPACET 100977 UV POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TARRE HAUTE, INDIANA 994791 ARTIFICIAL BURNT SUGAR FLAVOR 687817 AS MANUFACTURED IN TETERBORO, NJ AND BRANCHBURG, NEW JERSEY POLYETHYLENE PRODUCTS AS MANUFACTURED IN FREEPORT, TX; PLAQUEMINE, LA; ALBERTA, CANADA; TARRAGONA, SPAIN; TERNEUZEN, THE NETHERLANDS; SCHKOPAU, GERMANY AND MAP TA PHUT, RP THAILAND DAISOGEL SP-C8 SERIES CHEMICALLY MODIFIED SILICA GEL AS MANUFACTURED IN HYOGO, JAPAN DIPALMITOYL PHOSPHATIDYLGLYCEROL, SODIUM SALT (DPPG-NA) AS MANUFACTURED IN HYOGO, JAPAN MOMETASONE FUROATE AS MANUFACTURED IN CAIROLI (PAVIA), ITALY SGD-1269 (SG9) AS MANUFACTURED IN MADISON, WISCONSIN LANSOPRAZOLE ACTIVE SUBSTANCE AS MANUFACTURED IN NOVO MESTO, SLOVENIACE PTH (1-34), HUMAN, ACETATE AS MANUFACTURED IN TORRANCE, CALIFORNIA ANASTROZOLE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA DESMOPRESSIN ACETATE, AS MANUFACTURED IN SHAN-HUA, TAINAN, TAIWAN RIFAMYCIN O AS MANUFACTURED IN MAHARASHTRA, INDIA LIQUID COLORANT FOR USE IN COLORING PET AS MANUFACTURED IN BEREA, OHIO CEFUROXIME AXETIL USP (CRYSTALLINE) AS MANUFACTURED IN PUNJAB, INDIA LACTULOSE SOLUTION USP AS MANUFACTURED IN GRAZ, AUSTRIA DEXTROMETHORPHAN POLISTIREX AS MANUFACTURED IN CHARLES CITY, IA PREGABALIN (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA AZITHROMYCIN AS MANUFACTURED IN SHIJIAZHUANG, HEBEI PROVINCE, China

NINGXIA QIYUAN PHARMACEUTICAL CO LTD ERYTHROMYCIN THIOCYANATE AS MANUFACTURED NINGXIA, CHIANA

Page 675

4Q2012EXCEL DMF# 22333 22334 22335 A 22336 22337 22338 22339 22340 22341 22342 22343 A 22344 A 22345 A 22346 A 22347 22348 22349 A 22350 22351 22352 22353 22354 22355 22356 A 22357 22358 22359 22360 22361 A 22362 22363 A 22364 22365 22366 A A A II II II 12/30/2008 12/29/2008 12/30/2008 CADILA HEALTHCARE LTD TRIFARMA SPA MYLAN LABORATORIES LTD LOSARTAN POTASSIUM AS MANUFACTURED IN GUJARAT INDIA EXEMESTANE AS MANUFACTURED IN CERIANO LAGHETTO, ITALY RASAGILINE MESYLATE AS MANUFACTURED IN MAHARASHTRA, INDIA A II II 12/24/2008 12/29/2008 ALEMBIC PHARMACEUTICALS LTD CADILA HEALTHCARE LTD A A A A II II III II III 12/30/2008 12/29/2008 11/21/2008 12/31/2008 12/31/2008 RANBAXY LABORATORIES LTD SEQUENT SCIENTIFIC LTD RITE SYSTEMS INC SCINOPHARM TAIWAN LTD HOSPIRA INC A A A I A A II II II II II II II 12/22/2008 12/22/2008 12/30/2008 12/30/2008 12/17/2008 12/30/2008 12/19/2008 MSN PHARMACHEM PVT LTD PIERRE FABRE MEDICAMENT RANBAXY LABORATORIES LTD RANBAXY LABORATORIES LTD MYLAN LABORATORIES LTD AARTI DRUGS LTD A A II II II 12/24/2008 12/22/2008 12/23/2008 IV 11/18/2008 IV 11/18/2008 IV 11/18/2008 P A A A A A A II II II II III II III 3/26/2009 3/30/2009 12/23/2008 12/23/2008 12/17/2008 12/17/2008 11/24/2008 *** PENDING FILING REVIEW *** JUBILANT LIFE SCIENCES LTD JUBILANT LIFE SCIENCES LTD SMS PHARMACEUTICALS LTD SMS PHARMACEUTICALS LTD RELIANCE INDUSTRIES LTD ESTEVE QUIMICA SA SHANDONG PHARMACEUTICAL GLASS CO LTD BRAHMAR CELLULOSE PRODUCTS PRIVATE LTD BRAHMAR CELLULOSE PRODUCTS PRIVATE LTD BRAHMAR CELLULOSE PRODUCTS PRIVATE LTD FARMAK AS BIOFER SPA CHEMO IBERICA SA STATUS Type SUBMIT DATE A P II 12/7/2010 II 3/31/2009 HOLDER JUBILANT LIFE SCIENCES LTD *** PENDING FILING REVIEW *** JUBILANT LIFE SCIENCES LTD SUBJECT ALENDRONATE SODIUM (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA

4Q2012

ESOMEPRAZOLE MAGNESIUM DIHYDRATE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA PAROXETINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA RABEPRAZOLE SODIUM (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA ARIPIPRAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ONDANSETRON HYDROCHLORIDE USP AS MANUFACTURED ANDHRA PRADESH, INDIA RELENE 53EA010 AS MANUFACTURED IN MAHARASHTRA, INDIA AMLODIPINE BESYLATE AS MANUFACTURED IN CELRA (GIRONA), SPAIN ASSEMBLAGES FOR PREFILLED SYRINGESAS MANUFACTURED IN ZIBO CITY, P.R. CHINA CARBOXYMETHYLCELLULOSE SODIUM USP-NF AS MANUFACTURED IN TAMILNADU, INDIA MICROCRYSTALLINE CELLULOSE USP-NF AS MANUFACTURED IN TAMILNADU, INDIA CROSCARMELLOSE SODIUM USP-NF AS MANUFACTURED IN TAMILNADU, INDIA ZOPICLONE AS MANUFACTURED IN OLOMOUC, CZECH REPUBLIC HEPARIN SODIUM INJECTION AS MANUFACTURED IN MEDOLLA (MO) ITALY SEVELAMER HYDROCHLORIDE MANUFACTURED IN ZHEJIANG PROVINCE PROC FOR CHEMO IBERICA SA MADRID RANOLAZINE AS MANUFACTED IN ANDHRA PRADESH, INDIA F2695 AS MANUFACTURED IN GAILLAC, FRANCE TELMISARTAN (NON-STERILE BULK) AS MANUFACTURED IN PUNJAB, INDIA MEROPENEM TECHNICAL AS MANUFACTURED IN MADHYA PRADESH, INDIA TIZANIDINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA TICLOPIDINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA

NINGXIA QIYUAN PHARMACEUTICAL CO LTD TETRACYCLINE HYDROCHLORIDE AS MANUFACTURED IN NINGXIA CHINA ORLISTAT (NON-STERILE BULK) AS MANUFACTURED IN MADHYA PRADESH, INDIA ACITRETIN BP AS MANUFACTURED IN KARNATAKA, INDIA AMBER, LQC-BR1966-1 AS MANUFACTURED IN WEST CHICAGO IL AZACITIDINE AS MANUFACTURED IN TAINAN TAIWAN ROC STANDARD MICROBIOLOGICAL METHODS FOR CONTRACT MANUFACTURED DRUG PRODUCT PACKAGED IN GLASS VIALS AS MANUFACTURED IN ROCKY MOUNT NC CLONIDINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACFACTURED IN GUJARAT , INDIA

Page 676

4Q2012EXCEL DMF# 22367 22368 22369 22370 22371 22372 A 22373 A 22374 A 22375 22376 A 22377 22378 22379 A 22380 22381 22382 22383 A 22384 A 22385 A 22386 A 22387 22388 A 22389 A 22390 A 22391 22392 22393 A 22394 22395 A 22396 A IV 1/9/2009 SYMRISE INC A IV 1/8/2009 A A II II II 1/9/2009 1/9/2009 12/31/2008 MACLEODS PHARMACEUTICALS LTD DAIICHI SANKYO CO LTD CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTD TRASIS SA SYMRISE INC FAMCICLOVIR AS MANUFACTURED IN GUJARAT, INDIA SUN13837 DRUG SUBSTANCE AS MANUFACTURED IN TOKYO, JAPAN 6-AMINO-PENICILLANIC ACID (BY DIRECT METHOD) AS MANUFACTURED IN SHIJIAZHUANG, CHINA II 12/31/2008 II 1/7/2009 A II II 12/22/2008 1/6/2009 III 12/24/2008 III 12/24/2008 III 12/24/2008 A A A II II II III 12/26/2008 1/6/2009 1/4/2009 12/24/2008 MACLEODS PHARMACEUTICALS LTD HETERO DRUGS LTD CHEMAGIS LTD SHANDONG PHARMACEUTICAL GLASS CO LTD SHANDONG PHARMACEUTICAL GLASS CO LTD SHANDONG PHARMACEUTICAL GLASS CO LTD SHANDONG PHARMACEUTICAL GLASS CO LTD LAURUS LABS PRIVATE LTD DISHMAN PHARMACEUTICALS AND CHEMICALS LTD GENTHON BV A A III III II 12/14/2008 12/23/2008 12/25/2008 TRIVENI POLYMERS PRIVATE LTD WINPAK HEAT SEAL PACKAGING INC MEGAFINE PHARMA P LTD A II II 12/31/2008 12/31/2008 MACLEODS PHARMACEUTICALS LTD DR REDDYS LABORATORIES LTD III 12/16/2008 GRAND PLAST CO LTD II 1/2/2009 SREENIVASA PHARMA PRIVATE LTD STATUS Type SUBMIT DATE A A A I A II II II II II II 1/2/2009 12/27/2008 12/20/2008 12/27/2008 12/27/2008 12/27/2008 HOLDER KUMAR ORGANIC PRODUCTS LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD MATRIX LABORATORIES LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD SUBJECT MINOXIDIL USP AS MANUFACTURED IN BANGALORE, INDIA

4Q2012

FEXOFENADINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA DEFERASIROX AS MANUFACTURED IN ANDHRA PRADESH, INDIA OXCARBAZEPINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA O-DESMETHYL VENLAFAXINE SUCCINATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA COLLAPSIBLE PLASTIC TUBES FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN BANGKOK, THAILAND LEVOFLOXACIN HEMIHYDRATE AS MANUFACTURED IN GUJARAT, INDIA ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA PLASTIC CAPS/CLOSURES AS MANUFACTURED IN HARYANA, INDIA FLEXIBLE PACKAGING MATERIALS AS MANUFACTURED IN QUEBEC, CANADA DONEPEZIL HYDROCHLORIDE (FORM-1), (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN NASHIK, INDIA DONEPEZIL HCL AS MANUFACTURED IN GUJARAT, INDIA TOLTERODINE TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA DONEPEZIL BASE AS MANUFACTURED IN BEER SHEVA, ISRAEL POLYISOPRENE RUBBER CAPS FOR NEEDLES FOR PREFILLED SYRINGES AS MANUFACTURED IN ZIBO CITY, P.R. CHINA HALOGENATED BUTYL RUBBER PLUNGERS FOR PREFILLED AS MANUFACTURED IN ZIBO CITY, P.R. CHINA HALOGENATED BUTYL RUBBER PLUNGERS AND DISCS FOR PEN-INJECTORS AS MANUFACTURED IN ZIBO CITY, P.R. CHINA ALU-CAPS FOR PEN-INJECTORS AS MANUFACTURED IN ZIBO CITY, P.R. CHINA OXALIPLATIN PH. EUR. AS MANUFACTURED IN ANDHRA PRADESH, INDIA INDAPAMIDE AS MANUFACTURED IN GUJARAT, INDIA

TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN PRAGUE, CZECH REPUBLIC; SAN LORENZO, ARGENTINA; BLANSKO, CZECH REPUBLIC; FOR GENTHON BV NINGXIA QIYUAN PHARMACEUTICAL CO LTD ERYTHROMYCIN AS MANUFACTURED IN YINCHUAN, NINGXIA, CHINA

688617 EVOGLASS NATURAL FLAVOR PINEAPPLE TYPE AS MANUFACTURED IN TETERBORO, NJ AND BRANCHBURG, NJ 694942 EVOGLASS NATURAL & ARTIFICIAL FLAVOR GRAPE TYPE AS MANUFACTURED IN TETERBORO, NJ AND BRANCHBURG, NJ Page 677

4Q2012EXCEL DMF# 22397 A 22398 A 22399 22400 A 22401 22402 A 22403 A 22404 22405 A 22406 22407 A 22408 22409 A 22410 A 22411 22412 22413 A 22414 22415 22416 A 22417 A 22418 22419 A 22420 22421 22422 A 22423 A II 12/25/2008 ALP PHARM BEIJING CO LTD A A II II II 1/22/2009 1/21/2009 12/26/2008 REGIS TECHNOLOGIES INC FARMABIOS S P A IND SWIFT LABORATORIES LTD A II II 1/16/2009 1/21/2009 GLENMARK GENERICS LTD ERREGIERRE SPA II 1/29/2009 PFIZER INC A A IV IV III 1/16/2009 1/16/2009 1/15/2009 A A III III II 1/15/2009 1/15/2009 1/16/2009 RELIANCE INDUSTRIES LTD RELIANCE INDUSTRIES LTD SHANDONG NEW TIME PHARMACEUTICAL CO LTD FONA INTERNATIONAL INC FONA INTERNATIONAL INC 3M DRUG DELIVERY SYSTEMS III 1/16/2009 HUHTAMAKI RONSBERG P III 1/12/2009 *** PENDING FILING REVIEW *** 3M DRUG DELIVERY SYSTEMS A II II 1/5/2009 1/13/2009 NEWCHEM SPA EUTICALS SPA A II II 1/16/2009 1/15/2009 SMS PHARMACEUTICALS LTD LIGHT SCIENCES ONCOLOGY INC III 1/7/2009 NEX PERFORMANCE FILMS A II IV 12/10/2008 1/5/2009 CTX LIFE SCIENCES PVT LTD CRODA INC A II II 1/12/2009 1/12/2009 CHEMAGIS LTD SYMBIOTEC PHARMALAB LTD III 12/22/2008 DANAPAK FLEXIBLES AS STATUS Type SUBMIT DATE IV 1/8/2009 HOLDER SYMRISE INC SUBJECT

4Q2012

688620 EVOGLASS NATURAL & ARTIFICIAL ORANGE FLAVOR AS MANUFACTURED IN TETERBORO, NJ AND BRANCHBURG, NJ DANAEXTRA, COMPOSITION: PET 23 UM/PRINT WHITE 5G/M2/PE 13,5 G/M2/ALUMINIUM FOIL 9 UM/PAN 50 UM AS MANUFACTURED IN SLAGELSE, DENMARK AND HORSENS, DENMARK TIOCONAZOLE AS MANUFACTURED IN BEER SHEVA, ISRAEL DESOXIMETASONE USP, (MICRONIZED) AS MANUFACTURED IN RAU, INDORE (M.P), INDIA OXYMETAZOLINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA SUPER REFINED ARLASOLVE DMI (DIMETHYL ISOSORBIDE) AS MANUFACTURED IN MILL HALL, PA APPLETON 1019 POLYETHYLENE SHEETING FILM AS MANUFACTURED IN TURNERS FALLS, MA AND MILTON, WI ROSIGLITAZONE MALEATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA TALAPORFIN SODIUM (LS11) LYOPHILIZED DRUG PRODUCT FORMULATION AND FILLING AS MANUFACTURED IN FERENTINO (FR), ITALY FOR LIGHT SCIENCES ONCOLOGY INC BETAMETHASONE 17-VALERATE MICRONIZED AS MANUFACTURED IN VERONA, ITALY DIHYDROERGOTAMINE MESYLATE USP/EP AS MANUFACTURED IN ROZZANO (MI), ITALY

3M SCOTCHPAK 9755 RELEASE LINER AS MANUFACTURED IN CORDOVA, IL; DECATUR, ALABAMA; GREENVILLE, SC; ZWIJNDRECHT, BELGIUM; COTTAGE GROVE, MN; SOUTH NEVADA, MO; ST. PAUL, MN; WEST ST. PAUL, MN; SE HUTCHINSON, MN HUHTAMAKI RONSBERG'S MULTI-LAYER PACKAGING FILM AS MANUFACTURED IN RONSBERG, GERMANY REPOL T200MK AS MANUFACTURED IN HAZIRA (GUJARAT), INDIA REPOL R120MK AS MANUFACTURED IN HAZIRA (GUJARAT), INDIA KETOROLAC TROMETHAMINE (NON-STERILE, BULK FORM) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA 825.0003C CHERRY FLAVOR ARTIFICIAL AS MANUFACTURED IN GENEVA, IL 856.0006C N-C GRAPE FLAVOR, ARTIFICIAL AS MANUFACTURED IN GENEVA, IL 3M COTRAN 9698 POLYURETHANE TAPE AS MANUFACTURED IN VALLEY, NE; BROOKINGS, SD; CORDOVA, IL LIPITOR (ATORVASTATIN CALCIUM) 10MG, 20MG, 40MG, 80MG ORALTABLETS (ESUB) AS MANUFACTURED IN CORK, IRELAND SOLIFENACIN SUCCINATE AS MANUFACTURED IN GUJARAT, INDIA BUPROPION HYDROBROMIDE AS MANUFACTURED IN SAN PAOLO D' ARGON (BERGAMO), ITALY ACETAZOLAMIDE, USP AS MANUFACTURED IN MORTON GROVE, IL CLOCORTOLONE PIVALATE (MICRONIZED) AS MANUFACTURED IN CAIROLI (PV), ITALY NARATRIPTAN HYDROCHLORIDE USP (VER: 01/NAR/1208/00) AS MANUFACTURED IN NAGAR (MOHALI) PUNJAB, INDIA MEPROBAMATE (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING, CHINA

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4Q2012EXCEL DMF# 22424 A 22425 A 22426 22427 22428 22429 22430 A 22431 A 22432 A 22433 A 22434 A 22435 A 22436 22437 22438 22439 22440 22441 22442 A 22443 22444 A 22445 A 22446 A 22447 A 22448 A 22449 A 22450 A III 1/14/2009 TEKNOR APEX CO III 1/7/2009 TEKNOR APEX CO III 1/7/2009 TEKNOR APEX CO III 1/7/2009 TEKNOR APEX CO III 1/7/2009 TEKNOR APEX CO III 1/14/2009 A II II 1/21/2009 1/20/2009 A A A A A A II II II II II II II 3/23/2009 3/16/2009 3/16/2009 1/21/2009 1/6/2009 1/21/2009 1/27/2009 SUN PHARMACEUTICAL INDUSTRIES LTD SUN PHARMACEUTICAL INDUSTRIES LTD SUN PHARMACEUTICAL INDUSTRIES LTD STERLING SRL CADILA PHARMACEUTICALS LTD BIO VECTRA INC II 1/22/2009 BHARAT PHARMA LTD II 1/22/2009 BHARAT PHARMA LTD III 1/14/2009 AMPACET CORP II 1/21/2009 II 1/15/2009 A A A A II II IV II II 1/21/2009 1/20/2009 1/7/2009 1/6/2009 1/7/2009 NECTAR LIFESCIENCES LTD ESTEVE QUIMICA SA CABOT SANMAR LTD LIPOID GMBH CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD IOL CHEMICALS AND PHARMACEUTICALS LTD RPG LIFE SCIENCES LTD II 12/12/2008 STATUS Type SUBMIT DATE II 12/10/2008 HOLDER ZHEJIANG WILD WIND PHARMACEUTICAL CO LTD ZHUHAI UNITED LABORATORIES CO LTD SUBJECT

4Q2012

CARBIDOPA (NON-STERILE, BULK FORM) AS MANUFACTURED IN DONGYANG CITY, CHINA METHYLDOPA(NON-STERILE, BULK FORM) AS MANUFACTURED IN DONGYANG CITY, CHINA CEFUROXIME AXETIL USP (AMORPHOUS) AS MANUFACTURED IN PUNJAB, INDIA AZELASTINE HYDROCHLORIDE AS MANUFACTURED IN TARRAGONA, SPAIN CAB-O-SIL GRADE M-5 (FUMED SILICA) AS MANUFACTURED IN TAMIL NADU, INDIA LIPOID MCT (PH.EUR., USP) AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY OLOPATADINE HCL AS MANUFACTURED IN TAIPEI HSIEN, TAIWAN IBUPROFEN USP 31 AS MANUFACTURED IN PUNJAB, INDIA RISPERIDONE USP (ACTIVE PHARMACEUTICAL INGREDIENT) AS MANUFACTURED IN MUMBAI, INDIA AMPACET PRODUCT 181724 DELSYM AMBER POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; LATEXO, TX; CARTERSVILLE, GA; HEATH, OH; DERIDDER, LA BTD 177: 17.7% NITROGLYCERIN IN SOLVATED ADHESIVE AS MANUFACTURED IN LALITPUR (UP), INDIA NITROGLYCERIN AS IN DILUTED NITROGLYCERIN, USP AS MANUFACTURED IN LALITPUR (UP), INDIA GLIMEPIRIDE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA SUN-8016 (ESUB) AS MANUFACTURED IN GUJARAT, INDIA RILUZOLE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA EXEMESTANE AS MANUFACTURED IN PERUGIA, ITALY ESCITALOPRAM OXALATE AS MANUFACTURED IN GUJARAT, INDIA ZERANOL AS MANUFACTURED IN CHARLOTTETOWN, PE

JOHNSON MATTHEY INC PHARMACEUTICAL LISDEXAMFETAMINE DIMESYLATE AS MANUFACTURED IN WEST DEPTFORD, NJ MATERIALS GROUP CADILA PHARMACEUTICALS LTD TELMISARTAN AS MANUFACTURED IN GUJARAT, INDIA SHANDONG ZHONGYUAN GREENTECH CO LTD TEKNOR APEX CO CHONDROITIN SULFATE SODIUM AS MANUFACTURED IN SHANDONG PROVINCE, CHINA MEDALIST MD-220 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY MEDALIST MD-200 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY MEDALIST MD-205 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY MEDALIST MD-210 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY MEDALIST MD-215 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY MEDALIST MD-225 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY

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4Q2012EXCEL DMF# 22451 A 22452 A 22453 A 22454 A 22455 A 22456 A 22457 A 22458 A 22459 A 22460 A 22461 22462 22463 A 22464 A 22465 22466 A 22467 A 22468 22469 22470 22471 22472 22473 A 22474 22475 22476 22477 A 22478 A II 2/3/2009 AVECIA BIOTECHNOLOGY INC A A A II II II V 1/23/2009 1/20/2009 1/20/2009 1/22/2009 NIPPON SUISAN KAISHA LTD VASA PHARMACHEM PVT LTD VASA PHARMACHEM PVT LTD AUROBINDO PHARMA LTD N A A A A II II II II II 1/28/2009 1/28/2009 1/30/2009 1/22/2009 1/29/2009 NOT AN ASSIGNED NUMBER DIVIS LABORATORIES LTD DIVIS LABORATORIES LTD SRINI PHARMACEUTICALS LTD CADILA PHARMACEUTICALS LTD AUROBINDO PHARMA LTD IV 1/22/2009 SYMRISE INC A III IV 1/27/2009 1/21/2009 II 1/23/2009 A A IV III II 10/22/2008 11/24/2008 1/16/2009 FONA INTERNATIONAL INC STARPET INC 862.015 NAT & ART LEMON FLAVOR AS MANUFACTURED IN GENEVA, IL PERFORMANCE PET 1708CC AS MANUFACTURED IN ASHEBORO, NC II 1/23/2009 IV 1/27/2009 IV 1/27/2009 IV 1/27/2009 IV 1/27/2009 IV 1/27/2009 IV 1/27/2009 IV 1/27/2009 MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS CENTAUR PHARMACEUTICALS PRIVATE LTD III 1/14/2009 TEKNOR APEX CO STATUS Type SUBMIT DATE III 1/14/2009 HOLDER TEKNOR APEX CO SUBJECT

4Q2012

MEDALIST MD-230 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY MEDALIST MD-235 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY 715770 - NATURAL AND ARTIFICIAL CHERRY FLAVOR AS MANUFACTURED IN CLARK, NEW JERSEY 715846 - NATURAL LEMON FLAVOR WONF AS MANUFACTURED IN CLARK, NEW JERSEY 715870 - NATURAL MINT FLAVOR WONF AS MANUFACTURED IN CLARK, NEW JERSEY 716021 - NATURAL AND ARTIFICIAL MIXED BERRY FLAVOR AS MANUFACTURED IN CLARK, NEW JERSEY 715990 - NATURAL ORANGE FLAVOR WONF AS MANUFACTURED IN CLARK, NEW JERSEY 715787 - NATURAL AND ARTIFICIAL STRAWBERRY FLAVOR AS MANUFACTURED IN CLARK, NEW JERSEY 715680 - NATURAL AND ARTIFICIAL WINTERGREEN FLAVOR AS MANUFACTURED IN CLARK, NEW JERSEY LORAZEPAM USP AS MANUFACTURED IN MAHARASHTRA, INDIA

CHONGQING KANGLE PHARMACEUTICAL CO CILOSTAZOL USP (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN CHEMICAL LTD INDUSTRIAL PARK, CHINA AUROBINDO PHARMA LTD OXACILLIN FOR INJECTION USP (STERILE BULK) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOAMEX INNOVATIONS OPERATING CO Z110CLMA AS MANUFACTURED IN FORT WAYNE, IN SYMRISE INC 623586 ARTIFICIAL VANILLA CREAM FLAVOR POWDER 970W312 AS MANUFACTURED IN TETEBORO, NJ AND BRANCHBURG, NJ 623590 MICROSEAL ARTIFICIAL STRAWBERRY FLAVOR 979W311 AS MANUFACTURED IN TETEBORO, NJ AND BRANCHBURG, NJ DEXTROMETHORPHAN BASE AS MANUFACTURED IN ANDHRA PRADESH, INDIA VENLAFAXINE HCL AS MANUFACTURED IN ANDHRA PRADESH, INDIA OMEPRAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA O-DESMETHYL VENLAFAXINE SUCCINATE AS MANUFACTURED IN GUJARAT, INDIA NAFCILLIN SODIUM (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) MANUFACTURED IN ANDHRA PRADESH, INDIA EPA-E NISSUI AS MANUFACTURED IN IBARAKI-PREF., JAPAN MAGNESIUM CARBONATE (HEAVY) AS MANUFACTURED IN GUJARAT, INDIA MANESIUM OXIDE (HEAVY) AS MANUFACTURED IN GUJARAT, INDIA STERILE MANUFACTURING FACILITY OF AUROBINDO PHARMA LIMITED, UNIT-V AT HYDERABAD, INDIA NFKB (OLIGONUCLEOTIDE ATO) ACTIVE PHARMACEUTICAL INGREDIENT (API) AS MANUFACTURED IN MILFORD MA

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4Q2012EXCEL DMF# 22479 22480 A 22481 22482 22483 22484 22485 22486 22487 A 22488 A 22489 A 22490 A 22491 A 22492 A 22493 A 22494 A 22495 22496 A 22497 A 22498 A 22499 A 22500 A 22501 I 22502 A 22503 22504 A 22505 A II 2/25/2009 LUPIN LTD A II II 2/4/2009 2/4/2009 ACS DOBFAR SPA ANQIU LUAN PHARMACEUTICAL CO LTD III 1/29/2009 III 1/19/2009 IV 2/2/2009 IV 2/2/2009 IV 2/2/2009 IV 2/2/2009 A III II 2/4/2009 12/31/2008 IV 2/2/2009 IV 2/2/2009 IV 2/2/2009 IV 2/2/2009 IV 2/2/2009 IV 2/2/2009 MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS ALLTUB MEXICO CHANGZHOU TIANHUA PHARMACEUTICAL CO LTD MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS BERRY PLASTICS CORP TAPES AND COATINGS DIV INGENIA POLYMERS CORP III 2/6/2009 A A A A A A II II III II II II II 2/6/2009 2/5/2009 1/26/2009 2/5/2009 2/3/2009 2/6/2009 12/31/2008 CSPC INNOVATION PHARM CO LTD MSN PHARMACHEM PVT LTD TRASIS SA MSN PHARMACHEM PVT LTD MYLAN LABORATORIES LTD NEULAND LABORATORIES LTD CHANGZHOU TIANHUA PHARMACEUTICAL CO LTD WITTENBURG BV STATUS Type SUBMIT DATE A II II 1/30/2009 2/6/2009 HOLDER DR REDDYS LABORATORIES LTD SPI PHARMA INC SUBJECT CAPECITABINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

4Q2012

MAGNESIUM HYDROXIDE DC MS90 PRODUCTS AS MANUFACTURED IN SEPTEMES LES VALLONS FRANCE THEOPHYLLINE AS MANUFACTURED IN HEBEI CHINA SUMATRIPTAN SUCCINATE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA SINGLE USE CARTRIDGE AS MANUFACTURED BY MEDI-LINE S.A. IN LIEGE, BELGIUM MONTELUKAST SODIUM [MB ROUTE] AS MANUFACTURED IN ANDHRA PRADESH INDIA S-PREGABALIN AS MANUFACTURED IN ANDHRA PRADESH INDIA TIOTROPIUM BROMIDE AS MANUFACTURED IN BONTHAPALLI INDIA TETRACAINE HYDROCHLORIDE AS MANUFACTURED IN JIANGSU PR CHINA CAWITON PR6949 AND CAWITON PR8909 AS MANUFACTURED IN NIJKERKERVEEN THE NETHERLANDS 700511 - NATURAL AND ARTIFICIAL PINEAPPLE FLAVOR AS MANUFACTURED IN CLARK, NJ AND COMMERCE, CA 700437 - NATURAL AND ARTIFICIAL BANANA FLAVOR AS MANUFACTURED IN CLARK, NJ AND COMMERCE, CA 700443 - NATURAL AND ARTIFICIAL ORANGE FLAVOR AS MANUFACTURED IN CLARK, NJ AND COMMERCE, CA 700439 - NATURAL AND ARTIFICIAL ORANGE PINEAPPLE FLAVOR AS MANUFACTURED IN CLARK, NJ AND COMMERCE, CA 700059 - NATURAL AND ARTIFICIAL STRAWBERRY FLAVOR AS MANUFACTURED IN CLARK, NJ AND COMMERCE, CA 707972 - NATURAL AND ARTIFICIAL STRAWBERRY FLAVOR AS MANUFACTURED IN CLARK, NJ AND COMMERCE, CA COLLAPSIBLE ALUMINIUM TUBES AS MANUFACTURED IN SANTA CLARA MEXICO TETRACAINE AS MANUFACTURED IN JIANGSU PR CHINA 700661 - NATURAL LEMON FLAVOR AS MANUFACTURED IN CLARK, NJ AND COMMERCE, CA 700075 - ARTIFICIAL VANILLA NUT FLAVOR AS MANUFACTURED IN CLARK, NJ AND COMMERCE, CA 700432 - NATURAL AND ARTIFICIAL FRUIT PUNCH FLAVOR AS MANUFACTURED IN CLARK, NJ AND COMMERCE, CA 700464 - NATURAL AND ARTIFICIAL CHOCOLATE FLAVOR AS MANUFACTURED IN CLARK, NJ AND COMMERCE, CA MS-C-84EAY AS MANUFACTURED IN COLUMBUS, GA INGENIA POLYMERS 1073 SLIP AND ANTIBLOCK MASTERBATCH IN PACKAGING MATERIALS AS MANUFACTURED IN ONTARIO, CANADA; ALBERTA, CANADA; AND HOUSTON, TEXAS MEROPENEM FOR INJECTION, (STERILE BULK) AS MANUFACTURED IN MILANO, ITALY ACETAMINOPHEN, OTC AS MANUFACTURED IN SHANG SHANDONG PROVINCE, P.R. CHINA NORETHINDRONE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA

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4Q2012EXCEL DMF# 22506 22507 A 22508 22509 A 22510 22511 A 22512 22513 22514 A 22515 A 22516 22517 A 22518 22519 22520 A 22521 A 22522 A 22523 A 22524 A 22525 A 22526 A 22527 A 22528 22529 A 22530 22531 22532 22533 A A A A II II II III 2/16/2009 2/11/2009 2/12/2009 2/10/2009 A II II 2/10/2009 1/24/2009 CONCORD BIOTECH LTD SHANDONG PHARMACEUTICAL GLASS CO LTD GLENMARK GENERICS LTD SEQUEL PHARMACHEM PRIVATE LTD MEDICHEM SA AMPACET CORP III 2/11/2009 TEKNOR APEX CO III 2/10/2009 TEKNOR APEX CO III 2/11/2009 TEKNOR APEX CO III 2/10/2009 TEKNOR APEX CO III 1/22/2009 TEKNOR APEX CO III 1/22/2009 TEKNOR APEX CO III 2/11/2009 TEKNOR APEX CO A A IV IV III 1/7/2009 1/7/2009 2/11/2009 SOLVAY CARBONATE FRANCE SOLVAY CARBONATE FRANCE TEKNOR APEX CO A IV V 2/10/2009 2/6/2009 GATTEFOSSE SAS XELLIA PHARMACEUTICALS APS II 1/16/2009 HUAYI ISOTOPES CORP I P V 1/30/2009 II 2/2/2009 ALEMBIC LTD API DIV *** PENDING FILING REVIEW *** WEST PHARMACEUTICAL SERVICES INC C II III 1/28/2009 2/5/2009 LAURUS LABS PRIVATE LIMITED ARTE CORP A II II 3/31/2009 2/6/2009 LUPIN LTD APOTEX PHARMACHEM INC STATUS Type SUBMIT DATE A II II 3/13/2009 3/26/2009 HOLDER LUPIN LTD LUPIN LTD SUBJECT

4Q2012

ETHINYL ESTRADIOL USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA NORETHINDRONE ACETATE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA LEVONORGESTREL USP (ESUB) AS MANUFACTURED IN MADHYA INDIA CEVIMELINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN BRANTFORD ON, CANADA BRIMONIDINE TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ONE-POINT-CUT AMPOULES FOR INJECTABLES AS MANUFACTURED IN IBARAKI PREFECTURE, JAPAN 6-AMINOPENICILLANIC ACID AS MANUFACTURED IN GUJARAT, INDIA WESTAR LINED SEAL RS WASHING PROCESS AS PERFORMED IN ESCHWEILER, GERMANY 3-N-BOC-5'-0-DIMETHOXYTRITYL-3'-0-NOSYL-THYMIDINE (BOC-FLT-PRECURSOR) AS MANUFACTURED IN JIANGSU PROVINCE, P.R. CHINA PECEOL AS MANUFACTURED IN SAINT-PRIEST, FRANCE STERILE VALIDATION PACKAGE FOR VANCOMYCIN HCL VIALS IN COPENHAGEN, DENMARK SODIUM CARBONATE, ANHYDROUS AS MANUFACTURED IN MEURTHE, FRANCE SODIUM BICARBONATE AS MANUFACTURED IN MEURTHE, FRANCE MEDALIST MD-240 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT; HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-245 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT; HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-300 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT; HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-305 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT; HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-310 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT; HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-315 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT; HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-320 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT; HENDERSON, KY FOR TEKNOR APEX CO MEDALIST MD-325 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT; HENDERSON, KY FOR TEKNOR APEX CO VANCOMYCIN HYDROCHLORIDE USP AS MANUFACTURED IN AHMEDABAD, INDIA GLASS (TYPE II) CONTAINERS FOR PARENTERAL PREPARATIONS AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA TADALAFIL AS MANUFACTURED IN GUJARAT, INDIA TRAMADOL HYDROCHLORID EP AS MANUFACTURED IN MAHARASHTRA, INDIA MED-201345/E AS MANUFACTURED IN CELRA (GIRONA), SPAIN AMPACET PRODUCT 11070-KT SITE 70 T AS MANUFACTURED IN RAYONG, THAILAND FOR AMPACET CORPORATION

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4Q2012EXCEL DMF# 22534 A 22535 A 22536 22537 A 22538 22539 A 22540 22541 A 22542 A 22543 A 22544 A 22545 A 22546 A 22547 22548 22549 22550 22551 22552 22553 A 22554 22555 22556 22557 22558 22559 22560 22561 22562 22563 22564 A A A A A A A A A C A V II II III III II III II II II II 2/4/2009 2/18/2009 3/13/2009 2/23/2009 2/23/2009 2/20/2009 2/9/2009 2/26/2009 2/26/2009 2/23/2009 2/18/2009 BASF SE TORRENT PHARMACEUTICALS LTD UNICHEM LABORATORIES LTD SABIC PETROCHEMICALS BV SABIC PETROCHEMICALS BV CHEMPACIFIC CORP HB FULLER CO HUBEI HAOSUN PHARMACEUTICAL CO LTD HUBEI HAOSUN PHARMACEUTICAL CO LTD HETERO LABS LTD ALCHEM INTERNATIONAL LTD A A A A A A II II II II II II II 2/16/2009 2/18/2009 2/19/2009 2/19/2009 2/19/2009 2/19/2009 2/16/2009 III 1/19/2009 III 1/19/2009 III 1/19/2009 III 1/19/2009 III 1/19/2009 A II II 2/19/2009 1/31/2008 A II II 2/17/2009 3/26/2009 DIPHARMA FRANCIS SRL ORCHID CHEMICALS AND PHARMACEUTICALS LTD SIGMA ALDRICH IRELAND LTD ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD GLASS BRANCH NORTH CHINA PHARMACEUTICAL CO LTD GLASS BRANCH NORTH CHINA PHARMACEUTICAL CO LTD GLASS BRANCH NORTH CHINA PHARMACEUTICAL CO LTD GLASS BRANCH NORTH CHINA PHARMACEUTICAL CO LTD GLASS BRANCH NORTH CHINA PHARMACEUTICAL CO LTD VASA PHARMACHEM PVT LTD VASA PHARMACHEM PVT LTD VASA PHARMACHEM PVT LTD VASA PHARMACHEM PVT LTD VASA PHARMACHEM PVT LTD VASA PHARMACHEM PVT LTD MALLINCKRODT INC ENTACAPONE AS MANUFACTURED IN BARANZATE (MI) ITALY A IV IV 2/17/2009 2/18/2009 II 2/23/2009 ZHEJIANG STARRY PHARMACEUTICAL CO LTD FONA INTERNATIONAL INC FONA INTERNATIONAL INC STATUS Type SUBMIT DATE III 10/1/2008 HOLDER HOSPIRA INC SUBJECT

4Q2012

STANDARD MICROBIOLOGICAL METHODS FOR CONTRACT MANUFACTURED DRUG PRODUCT PACKED IN ANSYR PLASTIC SYRINGES AS MANUFACTURED IN ROCKY MOUNT, NC IOHEXOL (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA 825.042 N-C NAT CHERRY FLAVOR (WONF) AS MANUFACTURED IN GENEVA, IL 877.0088U N-C COOLING MINT FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL

NISOLDIPINE (NON-STERILE BULK API) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA BROMPHENIRAMINE MALEATE AS MANUFACTURED IN CO. WICKLOW, IRELAND HYDROCHLOROTHIAZIDE AS MANUFACTURED IN ZHEJIANG, CHINA CONTAINERS FOR PARENTERAL PREPARATIONS MADE OF NEUTRAL BOROSILICATE GLASS (TYPE I) TUBING AS MANUFACTURED IN HEBEI PROVINCE, CHINA LOW-BOROSILICATE GLASS (TYPE I) CYLINDER FOR PEN-INJECTION FOR MEDICAL USE AS MANUFACTURED IN HEBEI PROVINCE, CHINA NEUTRAL BOROSILICATE GLASS (TYPE I) CYLINDER FOR PEN-INJECTION FOR MEDICAL USE AS MANUFACTURED IN HEBEI PROVINCE, CHINA CONTAINERS FOR PARENTERAL PREPARATIONS MADE OF LOW-BOROSILICATE GLASS (TYPE I) TUBING AS MANUFACTURED IN HEBEI PROVINCE, CHINA CONTAINERS FOR PARENTERAL PREPARATIONS MADE OF SODA-LIME GLASS (TYPE II) TUBING AS MANUFACTURED IN HEBEI PROVINCE, CHINA MAGNESIUM OXIDE LIGHT AS MANUFACTURED IN GUJARAT, INDIA MAGNESIUM CARBONATE LIGHT AS MANUFACTURED IN GUJARAT, INDIA MAGNESIUM HYDROXIDE AS MANUFACTURED IN GUJARAT, INDIA CALCIUM ACETATE AS MANUFACTURED IN GUJARAT, INDIA SODIUM CITRATE AS MANUFACTURED IN GUJARAT, INDIA CALCIUM CITRATE AS MANUFACTURED IN GUJARAT, INDIA METHYLNALTREXONE BROMIDE, CODE 1251 (ESUB) AS MANUFACTURED IN ST. LOUIS, MISSOURI TOXICITY REPORTS FOR KOLLICOAT RS 30 D OLANZAPINE DRUG SUBSTANCE AS MANUFACTURED IN GUJARAT, INDIA LOSARTAN POTASSIUM USP (ESUB) AS MANUFACTURED IN DHAR (M.P.), INDIA SABIC LDPE PCG81 AS MANUFACTURED IN GELEEN, THE NETHERLANDS SABIC LDPE PCG22 AS MANUFACTURED IN GELEEN, THE NETHERLANDS JLP080574 DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE, MD HL0916LV AS MANUFACTURED IN QUEBEC, CANADA GLIMEPIRIDE AS MANUFACTURED IN HUBEI, CHINA DOCETAXEL ANHYDROUS AS MANUFACTURED IN HUBEI, CHINA ARIPIPRAZOLE AS MANUFACTURED INANDHRA PRADESH, INDIA COLCHICINE EXTRA PURE GRADE AS MANUFACTURED IN HARYANA, INDIA

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4Q2012EXCEL DMF# 22565 A 22566 22567 A 22568 22569 A 22570 A 22571 A 22572 22573 22574 22575 22576 22577 A 22578 22579 22580 C 22581 A 22582 22583 22584 A 22585 22586 22587 22588 22589 A 22590 A 22591 A 22592 A 22593 22594 22595 A A A IV II II 2/19/2009 12/31/2008 12/31/2008 NUSIL TECHNOLOGY LLC HEBEI JINGYE CHEMICAL CO LTD HEBEI JINGYE CHEMICAL CO LTD III 3/4/2009 IV 3/4/2009 FILTRONA RICHMOND INC DBA FILTRONA POROUS TECHNOLOGIES AMARTARA PRIVATE LTD II 3/5/2009 POLYMED THERAPEUTICS INC A A A A II II II III II 2/26/2009 2/28/2009 2/27/2009 3/3/2009 2/27/2009 TORRENT PHARMACEUTICALS LTD DR REDDYS LABORATORIES LTD STERLING SRL GAYHEART PHARMACEUTICAL INC AUROBINDO PHARMA LTD A A II II II 2/20/2009 2/16/2009 2/26/2009 ALEMBIC PHARMACEUTICALS LTD LAKE CHEMICALS PRIVATE LTD SWAN CHEMICAL INC II 2/10/2009 AURISCO PHARMACEUTICAL LTD A A II II II 2/26/2009 2/26/2009 2/17/2009 ZYFINE DIV CADILA HEALTHCARE LTD DR REDDYS LABORATORIES LTD A I A A A II II II II II II 2/25/2009 2/25/2009 2/21/2009 2/26/2009 2/26/2009 2/5/2009 APOTEX PHARMACHEM INC NEULAND LABORATORIES LTD PHARMAZELL INDIA PRIVATE LTD NEWCHEM SPA NATCO PHARMA LTD OAK RIDGE NATIONAL LABORATORY III 2/19/2009 3M DRUG DELIVERY SYSTEMS II 2/23/2009 NOF CORP I II IV 2/23/2009 2/23/2009 DR REDDYS LABORATORIES LTD MYLAN BERTEK PHARMACEUTICALS INC N IV 2/20/2009 NOT AN ASSIGNED NUMBER NIPPON FINE CHEMICAL CO LTD STATUS Type SUBMIT DATE II 1/12/2009 HOLDER INDOCO REMEDIES LTD SUBJECT GLIMEPIRIDE USP (ESUB) AS MANUFACTURED IN DISTRICT RAIGAD, INDIA

4Q2012

A LIPOSOMAL EXCIPIENT, DIPALMITOYL PHOSPHATIDYLGLYCEROL WITH EDTA (DPPG WITH EDTA) AS MANUFACTURED IN TAKASAGO-CITY HYOGO, JAPAN CLOPIDOGREL PREMIX AS MANUFACTURED IN ANDHRA PRADESH, INDIA POLYOLPREPOLYMER -02 AS MANUFACTURED BY ORTEC INC IN EASLEY SOUTH CAROLINA ALPHA -SUCCINIMIDYLOXY CARBONYL- OMEGA -METHOXY, POLYOXYETHYLENE MW5000 AS MANUFACTURED IN KAWASAKI-SHI KANAGAWA, JAPAN 3M SCOTCHPAK 9738 POLYESTER FILM LAMINATE AS MANUFACTURED IN COTTAGE GROVE MN ZALEPLON AS MANUFACTURED IN BRANTFORD ON CANADA EZETIMIBE (FORM-X) AS MANUFACTURED IN ANDHRA PRADESH INDIA N-ACETYL TYROSINE AS MANUFACTURED IN CHENNAI INDIA METHYLPREDNISOLONE HEMISUCCINATE AS MANUFACTURED IN VERONA ITALY TRIHEXYPHENIDYL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA TUNGSTEN-188/RHENIUM-188 GENERATOR FOR THE ELUTION OF RHENIUM-188 AS SODIUM PERRHENATE (Na188ReO4) AS MFR IN OAK RIDGE TN EXEMESTANE AS MANUFACTURED IN AHMEDABAD GUJARAT INDIA FONDAPARINUX SODIUM AS MANUFACTURED IN ANDHRA PRADESH INDIA

CENTAUR PHARMACEUTICALS PRIVATE LTD CLONAZEPAM USP AS MANUFACTURED IN MAHARASHTRA INDIA 9-(2-PHOSPHONYLMETHOXYPROPYL) ADENINE (BULK) AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA PENTOSAN POLYSULFATE SODIUM AS MANUFACTURED IN GUJARAT INDIA CLONAZEPAM AS MANUFACTURED IN KARNATAKA, INDIA CHLOROXYLENOL (CAS NO 88-04-0) AS MANUFACTURED IN COUNTY DURHAM, ENGLAND ATORVASTATIN CALCIUM DRUG SUBSTANCE AS MANUFACTURED IN GUJARAT, INDIA SALMETEROL XINAFOATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CICLESONIDE AS MANUFACTURED IN CORCIANO PERUGIA, ITALY PACKING PROCESS AS MANUFACTURED IN CLEARWATER FL NAFCILLIN FOR INJECTION USP (STERILE) BULK AS MANUFACTURED IN ANDHRA PRADESH, INDIA DOXERCALCIFEROL DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, P.R. CHINA HI-LINK PREPOLYMER AND MEDICAL GRADE FEXIBLEPOLYURETHANE FOAM MADE USING HI-LINK PREPOLYMER AS MANUFACTURED IN ST. CHARLES, MI COLD FORM BLISTER FILM LAMINATE (PVC-ALUMINUM-OPA COMPOSITE) AS MANUFACTURED IN MAHARASHTRA, INDIA DDU-4351 SILICONE GEL AS MANUFACTURED IN CARPINTERIA, CA ASPIRIN AS MANUFACTURED IN SHIJIAZHUANG CITY, HEBEI, P.R. CHINA SALICYLIC ACID AS MANUFACTURED INSHIJIAZHUANG CITY HEBEI, P.R. CHINA

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4Q2012EXCEL DMF# 22596 22597 A 22598 A 22599 A 22600 I 22601 A 22602 22603 22604 22605 A 22606 22607 22608 A 22609 22610 22611 22612 A 22613 A 22614 22615 22616 22617 A 22618 A 22619 22620 22621 22622 22623 A 22624 A II 3/13/2009 CRYSTAL PHARMA SAU A A A A II II II II II 3/5/2009 3/13/2009 3/13/2009 3/13/2009 3/16/2009 PHARMAZELL INDIA PRIVATE LTD APOTEX PHARMACHEM INDIA PVT LTD APOTEX PHARMACHEM INDIA PVT LTD SRINI PHARMACEUTICALS LTD EMCURE PHARMACEUTICALS LTD V 3/10/2009 LUITPOLD PHARMACEUTICALS INC A P A II II 6/30/2009 4/3/2010 II 4/1/2010 IPCA LABORATORIES LTD *** PENDING FILING REVIEW *** IPCA LABORATORIES LTD IPCA LABORATORIES LTD ISOTRETINOIN USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA II 7/22/2009 A A A II II II II 3/12/2009 3/12/2009 3/13/2009 3/31/2009 A A III II IV 3/3/2009 3/12/2009 3/11/2009 REXAM HEALTHCARE OFFRANVILLE SAS DR REDDYS LABORATORIES LTD FONA INTERNATIONAL INC A A A II II IV II 2/27/2009 3/5/2009 1/19/2009 3/9/2009 WOCKHARDT LTD AJINOMOTO AMINOSCIENCE LLC BASF SE AMCOL HEALTH AND BEAUTY SOLUTIONS INC II 3/4/2009 KAMUD DRUGS PVT LTD DIPHENHYDRAMINE HYDROCHLORIDE USP AS MANUFACTURED IN SANGLI MAHARASHTRA, INDIA; KOLHAPUR, MAHARASHTRA, INIDA CHLOROTHIAZIDE SODIUM AS MANUFACTURED IN GUJARAT INDIA L-ALANYL-L-GLUTAMINE AS MANUFACTURED IN RALEIGH NC KOLLIDON CL AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY II 3/6/2009 EURAND PHARMACEUTICALS INC II 3/6/2009 II 3/5/2009 SHANDONG XINHUA PHARMACEUTICAL CO LTD SIGNA SA DE CV STATUS Type SUBMIT DATE A II III 3/5/2009 3/10/2009 HOLDER APOTEX PHARMACHEM INDIA PVT LTD ADHESIVES RESEARCH INC SUBJECT RILUZOLE AS MANUFACTURED IN BANGALORE, INDIA

4Q2012

MA-78 (A4397) ADHESIVE AS MANUFACTURED IN GLEN ROCK, PENNSYLVANIA AND LIMERICK, IRELAND LEVODOPA USP AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA SILDENAFIL CITRATE AS MANUFACTURED IN TOLUCA, MEXICO FOR APOTEX PHARMACHEM INC EUR-1084 ORALLY DISINTEGRATING TABLETS AS MANUFACTURED IN VANDALIA, OHIO

MICROSPONGE P009A-13 BENZOYL PEROXIDE (BENZOYL PEROXIDEIN METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER) AS MANUFACTURED IN LAFAYETTE LA PLASTIC CLOSED VIAL AS MANUFACTURED IN OFFRANVILE FRANCE DEXLANSOPRAZOLE (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH INDIA

Product 833.0185U FONATECH CAPPUCCINO FLAVOR, NAT & ART (MET) AS MANUFACTURED IN GENEVA IL BEIJING JIKANLITONG PHARM TECH CO LTD TETRACAINE HYDROCHLORIDE AS MANUFACTURED IN BEIJING CHINA FLAMMA SPA SCINOPHARM TAIWAN LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD IPCA LABORATORIES LTD MELATONIN AS MANUFACTURED IN BERGAMO ITALY FULVESTRANT AS MANUFACTURED IN TAIWAN ROC TRANS-RESVERATROL (SERIES A) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA PERINDOPRIL TERT-BUTYLAMINE PH EUR (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA VALSARTAN USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA

MESALAMINE USP (PROCESS II) (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA SUPPORTING FACILITY, EQUIPMENT & VALIDATION INFORMATION FOR MANUFACTURING FACILITY IN SHIRLEY, NY CLOPIDOGREL BISULFATE AS MANUFACTURED IN CHENNAI, INDIA CABERGOLINE AS MANUFACTURED IN BANGALORE INDIA NARATRIPTAN HYDROCHLORIDE AS MANUFACTURED IN BANGALORE INDIA AMLODIPINE BESYLATE AS MANUFACTURED IN CHOUTUPPAL AP INDIA TENOFOVIR DISOPROXIL FUMARATE ( ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA PREDNISOLONE SODIUM PHOSPHATE AS MANUFACTURED IN BOECILLO VALLADOLID SPAIN

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4Q2012EXCEL DMF# 22625 A 22626 22627 A 22628 22629 22630 22631 22632 22633 A 22634 A 22635 22636 22637 22638 A 22639 22640 22641 22642 22643 I 22644 A 22645 22646 22647 22648 22649 22650 22651 22652 A 22653 22654 22655 A 22656 22657 A A II IV 3/14/2009 3/23/2009 SEQUEL PHARMACHEM PRIVATE LTD HENKEL AG AND CO KGAA A A III II II 2/27/2009 3/9/2009 3/10/2009 MWV CALMAR GMBH IND SWIFT LABORATORIES LTD AURISCO PHARMACEUTICAL LTD A A A A A A A II II II II II II II II 3/23/2009 12/9/2008 12/9/2008 12/9/2008 12/9/2008 12/9/2008 12/9/2008 3/21/2009 III 3/17/2009 A A A A II II II IV II 5/12/2009 3/16/2009 3/19/2009 3/17/2009 12/25/2008 UNICHEM LABORATORIES LTD KAMUD DRUGS PVT LTD STERLING SRL ALFA ADHESIVES INC AKA SIMALFA A A A IV II II II 3/17/2009 3/19/2009 3/20/2009 3/30/2009 CAPSUGEL CEDARBURG PHARMACEUTICALS LLC CHEMPACIFIC CORP UNICHEM LABORATORIES LTD II 3/19/2009 DR REDDYS LABORATORIES LTD A A A A A III III III II II II 3/9/2009 3/9/2009 3/9/2009 3/16/2009 3/25/2009 3/16/2009 AMPACET CORP AMPACET CORP AMPACET CORP FORMOSA LABORATORIES INC SUN PHARMACEUTICAL INDUSTRIES LTD SEQUENT SCIENTIFIC LTD A II II 3/13/2009 3/12/2009 STATUS Type SUBMIT DATE II 3/13/2009 HOLDER LABORATORIO CHIMICO INTERNAZIONALE SPA CHEMPACIFIC CORP SCI PHARMTECH INC SUBJECT ACAMPROSATE CALCIUM AS MANUFACTURED IN SEGRATE MI ITALY BENDAMUSTINE HYDROCHLORIDE AS MANUFACTURED IN BALTIMORE MD

4Q2012

THREO-PHENYL-2-PIPERIDIN-2-YL-ACETIC ACID (RITALINIC ACID) AS MANUFACTURED IN TAOYUAN TAIWAN 11748-KM BLOMITE 48 AS MANUFACTURED IN RAYONG THAILAND 11078-KM BLOMITE 78 AS MANUFACTURED IN RAYONG THAILAND 11070-KM BLOMITE 70 AS MANUFACTURED IN RAYONG THAILAND SEVELAMER HYDROCHLORIDE AS MANUFACTURED IN TAOYUAN TAIWAN LETROZOLE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA HYDRALAZINE HYDROCHLORIDE AS MANUFACTURED IN NEW MANGALORE KARNATAKA INDIA O-DESMETHYL VENLAFAXINE SUCCINATE (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH INDIA VCAPS PLUS AS MANUFACTURED IN PUEBLA MEXICO NEPAFENAC ACTIVE DRUG SUBSTANCE AS MANUFACTURED IN GRAFTON WI CARMUSTINE DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE MD ALFUZOSIN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA DONEPEZIL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA PROBENECID USP AS MANUFACTURED IN MAHARASHTRA INDIA BUDESONIDE AS MANUFACTURED IN PERUGIA ITALY SIMALFA 309 AS MANUFACTURED IN HAWTHORNE NJ

CHONGQING KANGLE PHARMACEUTICAL CO CILOSTAZOL DRUG SUBSTANCE NON STERILE AS MANUFACTURED IN CHONGQING LTD CHEMICAL INDUSTRIAL PARK CHINA REXAM HEALTHCARE OFFRANVILLE SAS INJECTION BLOW MOULDED PLASTIC CONTAINERS AS MANUFACTURED IN OFFRANVILLE FRANCE DR REDDYS LABORATORIES LTD EXEMESTANE AS MANUFACTURED IN ANDHRA PRADESH INDIA MAHIMA LIFE SCIENCES PRIVATE LTD MAHIMA LIFE SCIENCES PRIVATE LTD MAHIMA LIFE SCIENCES PRIVATE LTD MAHIMA LIFE SCIENCES PRIVATE LTD MAHIMA LIFE SCIENCES PRIVATE LTD MAHIMA LIFE SCIENCES PRIVATE LTD AUROBINDO PHARMA LTD BETAMETHASONE SODIUM PHOSPHATE USP AS MANUFACTURED IN HARYANA INDIA DEXAMETHASONE SODIUM PHOSPHATE USP AS MANUFACTURED IN HARYANA INDIA BECLOMETHASONE DIPROPIONATE USP AS MANUFACTURED IN HARYANA INDIA BETAMETHASONE DIPROPIONATE USP AS MANUFACTURED IN HARYANA INDIA CLOBETASOL PROPIONATE USP AS MANUFACTURED IN HARYANA INDIA BETAMETHASONE VALERATE USP AS MANUFACTURED IN HARYANA INDIA SERTRALINE HYDROCHLORIDE CRYSTALLINE POLYMORPH FORM I AS MANUFACTURED IN ANDHRA PRADESH INDIA MK VII SPRAYER MEDICAL DEVICE AS MANUFACTURED IN HEMER, GERMANY CLARITHROMYCIN CITRATE AS MANUFACTURED IN PUNJAB INDIA 9-(2-PHOSPHONYIMETHOXYPROPYL) ADENINE AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA LAMOTRIGINE EP AS MANUFACTURED IN MAHARASHTRA INDIA DURO-TAK 87-616A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY NC

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4Q2012EXCEL DMF# 22658 22659 22660 A 22661 22662 22663 22664 22665 A 22666 22667 22668 22669 A 22670 22671 22672 22673 22674 22675 22676 22677 22678 22679 A 22680 A 22681 22682 A 22683 22684 22685 22686 22687 22688 22689 22690 22691 A 22692 A II 4/2/2009 A A A A A A A A II II II II II II II II II 4/1/2009 3/31/2009 3/26/2009 4/1/2009 3/31/2009 3/31/2009 3/31/2009 3/31/2009 3/27/2009 AARTI DRUGS LTD CADILA HEALTHCARE LTD ITALFARMACO SPA MARCUS RESEARCH LABORATORY INC CADILA HEALTHCARE LTD SCINOPHARM TAIWAN LTD CADILA HEALTHCARE LTD CADILA HEALTHCARE LTD ALEMBIC PHARMACEUTICALS LTD C II II 3/31/2009 3/20/2009 CAMBRIDGE MAJOR LABS INC EUTICALS SPA II 9/28/2009 CIMA LABORATORIES INC A A A A P A A A A II II II II II 5/14/2009 3/31/2009 3/31/2009 3/31/2009 3/25/2009 II II II II 3/27/2009 3/30/2009 3/30/2009 3/30/2009 HOVIONE PHARMASCIENCE LTD TORRENT PHARMACEUTICALS LTD TORRENT PHARMACEUTICALS LTD GLENMARK GENERICS LTD *** PENDING FILING REVIEW *** YUAN XINYAN GLENMARK GENERICS LTD GLENMARK GENERICS LTD DR REDDYS LABORATORIES LTD MEGAFINE PHARMA P LTD FINASTERIDE (API) (ESUB) AS MANUFACTURED IN HUNAN PROVINCE PRC RIZATRIPTAN BENZOATE AS MANUFACTURED IN GUJARAT INDIA LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA THALIDOMIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA IVERMECTIN USP AS MANUFACTURED IN TAIPA MACAU SAR QUETIAPINE FUMARATE AS MANUFACTURED IN GUJARAT INDIA CANDESARTAN CILEXETIL AS MANUFACTURED IN GUJARAT INDIA TROSPIUM CHLORIDE AS MANUFACTURED IN GUJARAT INDIA A A A II II II III 3/26/2009 3/25/2009 3/27/2009 3/10/2009 NISSAN CHEMICAL INDUSTRIES LTD AMINO CHEMICALS LTD SYNTHON BV AMPACET CORP A A A A II IV II II III 3/25/2009 3/25/2009 4/3/2009 3/23/2009 3/6/2009 DR REDDYS LABORATORIES LTD BASF SE SUN PHARMACEUTICAL INDUSTRIES LTD AARTI INDUSTRIES LTD NIPRO STERILE GLASS GERMANY AG TROSPIUM CHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA KOLLICOATE MAE 100 P AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY LANSOPRAZOLE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA MESNA AS MANUFACTURED IN MAHARASHTRA INDIA STATUS Type SUBMIT DATE A A II III IV 3/24/2009 3/14/2009 3/18/2009 HOLDER DR REDDYS LABORATORIES LTD PARIKH PACKAGING PVT LTD UNGERER AND CO SUBJECT

4Q2012

CITALOPRAM HYDROBROMIDE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA LAMINATES AND POUCHES AS MANUFACTURED IN GUJARAT INDIA ORANGE SPRAY DRIED FLAVOURING V7095-1NC1 AS MANUFACTURED IN BETHLEHEM PA

STERILE PREFILLABLE DISPOSABLE SYRINGES AS MANUFACTURED IN MUNNERSTADT, GERMANY NIP-022TM AS MANUFACTURED IN YAMAGUCHI JAPAN RASAGILINE MESYLATE AS MANUFACTURED IN MARSA MALTA ZOLPIDEM TARTRATE AS MANUFACTURED IN PROVINCIA DE SANTA FE ARGENTINA 807242 AO POLYETHYLENE MASTERBATCH AS MANUFACTURED IN ONTARIO CANADA

VENLAFAXINE HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN NASHIK INDIA CETIRIZINE HCI COATED GRANULES (ESUB) AS MANUFACTURED IN EDEN PRAIRIE MN DEXMEDETOMIDINE HYDROCHLORIDE FP-071 AS MANUFACTURED IN GERMANTOWN WI HYDRALAZINE HYDROCHLORIDE INJECTABLE GRADE AS MANUFACTURED IN VARESE ITALY S (-) RIVASTIGMINE BASE AS MANUFACTURED IN MAHARASHTRA INDIA VALSARTAN USP AS MANUFACTURED IN GUJARAT INDIA STERILE WATER FOR INJECTION USP AS MANUFACTURED IN MILAN POVIDONE IODINE (API) AS MANUFACTURED IN ST LOUIS MO TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA ZOLEDRONIC ACID AS MANUFACTURED IN TAINAN COUNTY TAIWAN ROC TELMISARTAN PH EUR AS MANUFACTURED IN GUJARAT INDIA VENLAFAXINE HYDROCHLORIDE PH EUR AS MANUFACTURED IN GUJARAT INDIA

O-DESMETHYL VENLAFAXINE SUCCINATE MONOHYDRATE AS MANUFACTURED IN GUJARAT INDIA SOUTHWEST SYNTHETIC PHARMACEUTICAL SULFADIAZINE AS MANUFACTURED IN CHONGQING PR CHINA CO LTD

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4Q2012EXCEL DMF# 22693 A 22694 22695 22696 22697 A 22698 A 22699 A 22700 22701 22702 22703 A 22704 22705 22706 A 22707 22708 22709 22710 22711 22712 22713 A 22714 22715 22716 22717 22718 A 22719 A 22720 22721 22722 A 22723 A II 4/15/2009 SANDOZ SYNTEK ILAC HAMMADDELERI SANAYI VE TICARET AS A A II II II 4/14/2009 4/14/2009 4/13/2009 DIPHARMA FRANCIS SRL AMINO CHEMICALS LTD OTSUKA CHEMICAL INDIA LTD IV 4/14/2009 SYMRISE INC A A A A II II IV IV II 3/25/2009 4/7/2009 4/8/2009 4/8/2009 4/7/2009 ARCH PHARMALABS LTD INALCO SPA FONA INTERNATIONAL INC FONA INTERNATIONAL INC BEIJING MEDIKING BIOPHARM CO LTD ENTACAPONE AS MANUFACTURED IN THANE INDIA D-(-)-TAGATOSE AS MANUFACTURED IN PISTOIA ITALY 816.0416U BUTTER FLAVOR NAT WONF AS MANUFACTURED IN GENEVA IL 816.0415U BUTTER FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA IL A A A A A A II II II II II II II 3/31/2009 4/6/2009 4/8/2009 3/30/2009 4/2/2009 4/8/2009 4/9/2009 ALEMBIC PHARMACEUTICALS LTD SEQUENT SCIENTIFIC LTD AARTI INDUSTRIES LTD AUCTUS PHARMA LTD AUCTUS PHARMA LTD ASAHI KASEI CHEMICALS CORP SIGNA SA DE CV I A II II III 4/7/2009 4/7/2009 4/7/2009 EMCURE PHARMACEUTICALS LTD SMS PHARMACEUTICALS LTD SHINKO CHEMICAL CO LTD A A A II III III III 4/2/2009 3/31/2009 3/31/2009 4/6/2009 MALLINCKRODT INC HUDSON COLOR CONCENTRATES HUDSON COLOR CONCENTRATES SABIC INNOVATIVE PLASTICS II 4/3/2009 CARDINAL HEALTH 414 LLC III 4/3/2009 I I A II II II II 3/27/2009 3/27/2009 4/3/2009 3/25/2009 ALEMBIC PHARMACEUTICALS LTD ALEMBIC PHARMACEUTICALS LTD GE HEALTHCARE INC DONGYING TIANDONG PHARMACEUTICAL CO LTD RENOLIT NEDERLAND BV STATUS Type SUBMIT DATE II 3/31/2009 HOLDER MITSUI NORIN CO LTD SUBJECT

4Q2012

POLYPHENON E (NON TOPICAL USE) AS MANUFACTURED IN HIDA-SHI GIFU JAPAN FOR MITSUI NORIN CO LTD O-DESMETHYL VENLAFAXINE AS MANUFACTURED IN GUJARAT INDIA ERYTHROMYCIN USP AS MANUFACTURED IN GUJARAT INDIA FASTLAB FDG CASSETTE PACK AS MANUFACTURED IN OSLO NORWAY HEPARIN SODIUM AS MANUFACTURED IN SHANDONG PROVINCE PR CHINA SOLMED WRAPFLEX AS MANUFACTURED IN ENKHUIZEN THE NETHERLANDS AND THANSAU, GERMANY 3-DEOXY-3-[18F]FLUOROTHYMIDINE ([18F]FLT) AS MANUFACTURED IN WOBURN MA; SEATTLE WA; AND BELTSVILLE MD METHADONE BASE SPECIAL (ESUB) AS MANUFACTURED IN ST LOUIS MO WHITE HC80003LD AS MANUFACTURED IN LEOMINSTER MA WHITE HC81372LD AS MANUFACTURED IN LEOMINSTER MA XYLEX * RESINS AS MANUFACTURED IN MT VERNON, INDIANA (USA), AND BERGEN-OPZOOM, THE NETHERLANDS. EFAVIRENZ (ALTERNATE PROCESS) AS MANUFACTURED IN MAHARASHTRA INDIA IMIDAPRIL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA STANDARD PLASTIC CONTAINER AS MANUFACTURED IN ISHIKAWA JAPAN (KANAZAWA FACTORY) AND ISHIKAWA JAPAN (MATTO FACTORY) TADALAFIL AS MANUFACTURED IN GUJARAT INDIA EFAVIRENZ AS MANUFACTURED IN KARNATAKA INDIA ADAPALENE AS MANUFACTURED IN MAHARASHTRA INDIA FLUCONAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA LOSARTAN POTASSIUM USP AS MANUFACTURED IN ANDHRA PRADESH INDIA ASAHI KASEI PVDC LATEX AS MANUFACTURED IN TOKYO JAPAN FAMCICLOVIR AS MANUFACTURED IN TOLUCA MEXICO FOR APOTEX PHARMACHEM INC

TROSPIUM CHLORIDE AS MANUFACTURED IN SHANDONG PROVINCE PR CHINA FOR BEIJING MEDIKING BIOPHARM CO LTD 828936 EVOGLASS NATURAL & ARTIFICIAL MIXED BERRY FLAVOR AS MANUFACTURED IN TETERBORO NJ AND BRANCHBURG NJ BUPROPION HYDROBROMIDE AS MANUFACTURED IN VARESE ITALY OLMESARTAN MEDOXOMIL AS MANUFACTURED IN MARSA MALTA P-METHOXYBENZYL (6R,7R)-3-CHLOROMETHYL-8-OXO-7-PHENYLACETAMIDO-5-THIA-LAZABICYCLO [4.2.0]OCT-2-ENE-2-CARBOXYLATE GCLE AS MANUFACTURED IN DISTT JAIPUR (RAJ) INDIA ATORVASTATIN ATV-44 INTERMEDIATE AS MANUFACTURED IN ISTANBUL TURKEY

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4Q2012EXCEL DMF# 22724 A 22725 22726 22727 A A III II III 4/15/2009 4/15/2009 9/23/2010 LUPIN LTD ZOGENIX INC STATUS Type SUBMIT DATE III 4/6/2009 HOLDER UNIQUE BLOWMOULDING INC SUBJECT

4Q2012

40ML WHITE HDPE BELL ROUND BOTTLE 18-415 AS MANUFACTURED IN ONTARIO CANADA XIO-2.0 SERIES FILM AS MANUFACTURED IN CHIPPEWA FALLS WI NORGESTIMATE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA (PACKAGING MATERIAL) FOR THE DOSEPRO NEEDLE-FREE DELIVERY SYSTEM (ESUB) AS MANUFACTURED IN SWINDON WILTSHIRE UK AND DUBLIN IRELAND FOR ZOGENIX INC ATORVASTATIN (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA NARATRIPTAN HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA CHLOROTHIAZIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA TELMISARTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA AMIKACIN 1.8 SULPHATE AS MANUFACTURED IN BERGAMO ITALY SODIUM ALENDRONATE AS MANUFACTURED IN PROVINCIA DE BUENOS AIRES ARGENTINE LIPOID E 80 N AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY NEBIVOLOL HYDROCHLORIDE AS MANUFACTURED IN LONIGO ITALY SYNTHETIC AMORPHOUS SILICA FOR CHROMATOGRAPHY PRODUCTS - CHROMATOREX AS MANUFACTURED IN AICHI-KEN JAPAN PACKAGING MATERIAL FOR PHARMACEUTICAL TABLETS/CAPULES/SOLID DOSAGE FORMS AS MANUFACTURED IN MAHARASHTRA INDIA TRAVOPROST AS MANUFACTURED IN TAOYUAN COUNTY TAIWAN MICROSPHERE DILUENT (ESUB) AS MANUFACTURED BY BAXTER PHARMACEUTICALS SOLUTIONS INC IN BLOOMINGTON INDIANA FOR ALKERMES INC SEVOFLURANE AS MANUFACTURED IN SHANDONG PROVINCE CHINA MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN PUNJAB INDIA ADVANTIA PREFERRED AS MANUFACTURED IN NORRISTOWN PA FOR INTERNATIONAL SPECIALTY PRODUCTS BIOPHARMACEUTICAL PRODUCTION FACILITY LOCATED IN BIBERACH, GERMANY QUETIAPINE HEMIFUMARATE (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN DIST NASHIK INDIA TOPIRAMATE AS MANUFACTURED IN GUJARAT INDIA SK 0403 DRUG SUBSTANCE AS MANUFACTURED IN IWATE JAPAN PIMOZIDE USP [TYPE-2] AS MANUFACTURED IN GUJARAT INDIA GEMCITABINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA DESONIDE MICRONIZED AS MANUFACTURED IN VERONA ITALY NOMEGESTROL ACETATE AS MANUFACTURED IN VERONA ITALY INDOMETHACIN SODIUM AS MANUFACTURED IN NEW MANGALORE KARNATAKA INDIA CALCIUM ACETATE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA

A 22728 A 22729 A 22730 22731 22732 22733 A 22734 22735 22736 A 22737 A 22738 22739 A 22740 A 22741 22742 A 22743 A 22744 A 22745 A 22746 22747 22748 22749 22750 22751 22752 A A A A A A A II II II II II II II 4/28/2009 4/23/2009 4/15/2009 4/21/2009 4/18/2009 4/29/2009 4/30/2009 II 4/20/2009 DISHMAN PHARMACEUTICALS AND CHEMICALS LTD SANWA KAGAKU KENKYUSHO CO LTD UNIMARK REMEDIES LTD INTAS PHARMACEUTICALS LTD NEWCHEM SPA NEWCHEM SPA SEQUENT SCIENTIFIC LTD SUVEN LIFE SCIENCES LTD II 4/20/2009 V 4/20/2009 BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG MEGAFINE PHARMA P LTD A II IV 4/23/2009 4/17/2009 II 4/20/2009 SHANDONG NEW TIME PHARMACEUTICAL CO LTD RANBAXY LABORATORIES LTD INTERNATIONAL SPECIALTY PRODUCTS C II II 4/20/2009 5/5/2009 CHIROGATE INTERNATIONAL INC ALKERMES INC III 4/14/2009 FOILS PLUS A A IV II II 4/16/2009 3/31/2009 4/17/2009 LIPOID GMBH ZACH SYSTEM SPA FUJI SILYSIA CHEMICAL LTD A A A II II II II 5/7/2009 4/7/2009 4/15/2009 4/17/2009 SUN PHARMACEUTICAL INDUSTRIES LTD MSN PHARMACHEM PVT LTD ACS DOBFAR SPA GADOR SA II 5/25/2009 SUN PHARMACEUTICAL INDUSTRIES LTD II 4/15/2009 LUPIN LTD

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4Q2012EXCEL DMF# 22753 22754 A 22755 22756 A 22757 22758 22759 22760 22761 22762 A 22763 A 22764 A 22765 22766 22767 A 22768 22769 22770 I 22771 A 22772 A 22773 22774 A 22775 22776 22777 22778 22779 A 22780 22781 22782 A 22783 A III 5/11/2009 A A V II II 4/30/2009 5/15/2009 5/15/2009 PHASE V TECHNOLOGIES INC CF PHARMA LTD ACTAVIS PHARMA MANUFACTURING PRIVATE LTD AMPACET CORP A A A A II II III IV V 5/12/2009 5/14/2009 5/8/2009 5/14/2009 5/13/2009 RELIANCE LIFE SCIENCES PVT LTD SIFAVITOR SRL RELIANCE INDUSTRIES LTD YASUHARA CHEMICAL CO LTD LABORATOIRES THISSEN SA A II III 5/13/2009 5/7/2009 INTERQUIM SA EXXONMOBIL CHEMICAL CO II 5/13/2009 TEVA PHARMACEUTICAL INDUSTRIES LTD II 5/13/2009 RANBAXY LABORATORIES LTD A A II IV II 5/8/2009 4/7/2009 5/12/2009 SEQUEL PHARMACHEM PRIVATE LTD SANYO CHEMICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD A A II II II 5/8/2009 5/7/2009 5/11/2009 II 5/8/2009 BOEHRINGER INGELHEIM LABSO CHIMIE FINE ANJAN DRUG PRIVATE LTD APICORE LLC TEVA PHARMACEUTICAL INDUSTRIES LTD II 5/8/2009 NATCO PHARMA LTD A A A A A II II V II II III 5/5/2009 5/1/2009 4/24/2009 5/4/2009 5/4/2009 5/4/2009 SANDOZ PRIVATE LTD EUTICALS SPA HAUPT PHARMA LATINA SRL NORDMARK ARZNEIMITTEL GMBH CO KG NORDMARK ARZNEIMITTEL GMBH CO KG AMPACET CORP A II IV 5/1/2009 5/4/2009 ALKERMES GAINESVILLE LLC LIFEBLOOD MEDICAL INC STATUS Type SUBMIT DATE A V II 6/25/2009 4/30/2009 HOLDER SANDOZ CANADA INC AUROBINDO PHARMA LTD SUBJECT

4Q2012

STERILE MANUFACTURING FACILITY LOCATED IN BOUCHERVILLE QC CANADA NAPROXEN USP (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA N1679 NANOCRYSTAL CAPSULE AS MANUFACTURED IN KING OF PRUSSIA PA LIFOR ACF PERFUSION MEDIA, A NOVEL EXCIPIENT AS MANUFACTURED IN LOGAN UTAH FOR LIFEBLOOD MEDICAL INC ESCITALOPRAM OXALATE AS MANUFACTURED IN MAHARASHTRA INDIA DIHYDROLYSERGIC ACID (INTERMEDIATE) AS MANUFACTURED IN ROZZANO MI ITALY STERILE PEN POWDERS ASEPTIC FACILITY LOCATED IN LATINA ITALY NEUTRAL PROTEASE NB GMP GRADE AS MANUFACTURED IN UETERSEN, GERMANY COLLAGENASE NB 1 GMP GRADE AS MANUFACTURED IN UETERSEN, GERMANY 612302-PT WHITE PET MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CATERSVILLE GA, AND HEATH OH RIZATRIPTAN BENZOATE (ROUTE - 2; PRODUCT CODE: RTB) AS MANUFACTURED IN ANDHRA PRADESH INDIA DIPYRIDAMOLE AS MANUFACTURED IN BLANQUEFORT FRANCE GABAPENTIN USP AS MANUFACTURED IN TAMIL NADU INDIA PROCARBAZINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN SOMERSET NJ TIGECYCLINE AS MANUFACTURED IN BEER SHEVA ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD TELMISARTAN EP AS MANUFACTURED IN MAHARASHTRA INDIA SANWET IM-300MPS AND LS-300 AS MANUFACTURED IN AICHI JAPAN CASPOFUNGIN AS MANUFACTURED IN BEER SHEVA ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD TADALAFIL (NON STERILE BULK) DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB INDIA FLUNISOLIDE ANHYDROUS (NEW PROCESS) AS MANUFACTURED IN RHO (MI) ITALY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD RIVASTIGMINE TARTRATE AS MANUFACTURED IN BARCELONA SPAIN BROMINATED ISOBUTYLENE - PARAMETHYLSTYRENE RUBBER AS MANUFACTURED IN BAYTOWN TX TEMOZOLOMIDE USP (ESUB) AS MANUFACTURED IN NAVI MUMBAI INDIA TROSPIUM CHLORIDE AS MANUFACTURED IN LODI ITALY RELENE B56003 AS MANUFACTURED IN TAL VAGRA DIST BHARUCH INDIA YS RESIN PX 1150N AS MANUFACTURED IN EHIME JAPAN STERILIZATION PROCESS VALIDATION IN APPLICATIONS FOR HUMAN AND VETERINARY DRUG PRODUCTS LOCATED IN BRAINE I ALLEUD BELGIUM PHASE V OUTCOMES INFORMATION SYSTEM LOCATED IN WELLESLEY HILLS MA PENTOSAN POLYSULFATE SODIUM AS MANUFACTURED IN BUDAPEST HUNGARY RASAGILINE MESYLATE (NON STERILE BULK DRUG SUBSTANCE) TAMIL NADU INDIA 111717 A WHITE PE MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA AND HEATH OH

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4Q2012EXCEL DMF# 22784 22785 A 22786 A 22787 A 22788 A 22789 A 22790 22791 A 22792 A 22793 A 22794 22795 A 22796 22797 22798 22799 22800 22801 22802 22803 22804 A 22805 A 22806 22807 22808 A 22809 A 22810 A 22811 22812 A A II II 6/15/2009 5/29/2009 COSMA SPA NATCO PHARMA LTD RANOLAZINE (ESUB) AS MANUFACTURED IN CISERANO (BERGAMO) ITALY LETROZOLE (LER) AS MANUFACTURED IN ANDHRA PRADESH INDIA II 6/15/2009 II 5/8/2009 ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD ARCH PHARMALABS LTD A I III II II 5/19/2009 5/15/2009 5/27/2009 AMPACET CORP XIAN LIBANG PHARMACEUTICAL CO LTD APOTEX PHARMACHEM INC III 5/19/2009 AMPACET CORP A A A A C A C A III III III III II II II IV IV 10/31/2009 10/31/2009 5/8/2009 5/8/2009 5/16/2009 5/26/2009 5/15/2009 5/26/2009 5/7/2009 A II II 5/21/2009 3/23/2009 EMCURE PHARMACEUTICALS LTD YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD IMARETCIOGLU LTD CO IMARETCIOGLU LTD CO IMARETCIOGLU LTD CO IMARETCIOGLU LTD CO LAURUS LABS PRIVATE LIMITED APICORE LLC NEWCHEM SPA SHOWA DENKO KK DEEPAK CELLULOSE PVT LTD III 5/1/2009 CHOONGWAE CORP III 5/1/2009 CHOONGWAE CORP A IV II 5/20/2009 5/21/2009 BASF SE FARMASTUR 2010 SL II 5/15/2009 AUROBINDO PHARMA LTD III 5/13/2009 II 5/14/2009 CHONGQING BIOCARE PHARMACEUTICAL CO LTD AMPACET CORP II 5/13/2009 WUXI FORTUNE PHARMACEUTICAL CO LTD STATUS Type SUBMIT DATE A II II 5/15/2009 5/18/2009 HOLDER APOTEX PHARMACHEM INC MSN PHARMACHEM PVT LTD SUBJECT

4Q2012

BICALUTAMIDE AS MANUFACTURED IN AP INDIA FOR APOTEX PHARMACHEM INC ATORVASTATIN CALCIUM (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH INDIA MYCOPHENOLATE MOFETIL AS MANUFACTURED IN WUXI CITY JIANGSU PROVINCE PR CHINA RIFABUTIN USP AS MANUFACTURED IN CHONGQING CHINA 169625 BLUE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA, HEATH OH PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA Kolliphor(R) TPGS AS MANUFACTURED IN KANKAKEE IL AMPICILLIN AND SULBACTAM STERILE MIXTURE AS MANUFACTURED IN ASTURIAS SPAIN MEDITUBE (MT-400) AS MANUFACTURED IN KYEONGG DO KOREA FOR CHOONGWAE CORPORATION MEDIROLL (CT-800) AS MANUFACTURED IN KYEONGG DO KOREA FOR CHOONGWAE CORPORATION CYCLOPHOSPHAMIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA MECLOFENAMATE SODIUM YUNG SHIN AS MANUFACTURED IN TAIWAN ROC CLEAR ONE POINT CUT (OPC) AMPOUL AS MANUFACTURED IN SAMSUN TURKEY AMBER ONE POINT CUT (OPC) AMPOUL AS MANUFACTURED IN SAMSUN TURKEY AMBER COLOUR BREAK (CBR) AMPOUL AS MANUFACTURED IN SAMSUN TURKEY CLEAR COLOUR BREAK (CBR) AMPOUL AS MANUFACTURED IN SAMSUN TURKEY GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA AZACITIDINE (ESUB) AS MANUFACTURED IN SOMERSET NJ DROSPIRENONE AS MANUFACTURED IN VERONA ITALY VISCOMATE AS MANUFACTURED IN KANAGAWA JAPAN HYPROMELLOSE PHTHALATE USP NF (HYDROXYPROPYL METHYLCELLULOSE PHTHALATE USP NF) AS MANUFACTURED IN GUJARAT INDIA 112213 BLUE WHITE PE MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA, AND HEATH OH 11134 K SITE 34 AS MANUFACTURED IN RAYONG THAILAND SUCCINYLCHOLINE CHLORIDE AS MANUFACTURED IN SHAANXI PROVINCE CHINA TROSPIUM CHLORIDE AS MANUFACTURED IN BANGALORE KARNATAKA INDIA FOR APOTEX PHARMACHEM INC BUPROPION HYDROBROMIDE API AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA APIF12B (ESUB) AS MANUFACTURED BY VITALIFE LABORATORIES IN HARYANA INDIA FOR ARCH PHARMALABS LIMITED

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4Q2012EXCEL DMF# 22813 22814 22815 A 22816 A 22817 22818 A 22819 A 22820 22821 22822 22823 22824 22825 22826 A 22827 22828 22829 22830 22831 A 22832 A 22833 A 22834 A 22835 22836 22837 22838 A 22839 A 22840 A 22841 22842 A A II II 6/9/2009 6/9/2009 II 5/29/2009 ZHEJIANG JIANFENG HAIZHOU PHARMACEUTICAL CO LTD SANDOZ GMBH PRAVEEN LABORATORIES PVT LTD II 6/1/2009 YUNNAN HANDE BIO TECH CO LTD A A A II III III II 6/3/2009 6/5/2009 6/5/2009 6/4/2009 IV 6/2/2009 IV 6/2/2009 MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS CEDARBURG PHARMACEUTICALS INC ESSEL PROPACK AMERICAS LLC ARISTA TUBES INC SUB ESSEL PROPACK GE HEALTHCARE INC II 5/30/2009 AUROBINDO PHARMA LTD A A A A IV III II II V 5/1/2009 5/28/2009 6/2/2009 5/27/2009 5/29/2009 CRODA INC DAE HEUNG IBN INC CHEMPACIFIC CORP AUROBINDO DATONG BIO PHARMA CO LTD AUROBINDO PHARMA LTD A A A A A A III IV IV II II II IV 5/26/2009 5/22/2009 5/22/2009 5/29/2009 5/29/2009 6/1/2009 6/2/2009 ESSEL PACKAGING GUANGZHOU LTD ABELEI INC ABELEI INC ROTEM INDUSTRIES LTD DAIICHI FINE CHEMICAL CO LTD SUVEN LIFE SCIENCES LTD LIFEBLOOD MEDICAL INC II 5/28/2009 APOTEX PHARMACHEM INDIA PVT LTD A III III 5/15/2009 5/26/2009 KOSMA KARE CANADA INC KARL OTTO BRAUN GMBH AND CO KG II 6/18/2009 NORAMCO INC STATUS Type SUBMIT DATE A N IV 5/26/2009 II 5/25/2009 HOLDER UNIMARK REMEDIES LTD NOT AN ASSIGNED NUMBER NIPPON FINE CHEMICAL CO LTD SUBJECT LAMOTRIGINE AS MANUFACTURED IN GUJARAT INDIA

4Q2012

A LIPOSOMAL EXCIPIENT GLYCERYL TRICAPRYLATE (TRICAPRYLIN) AS MANUFACTURED IN HYOGO JAPAN OXYMORPHONE HYDROCHLORIDE DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN WILMINGTON, DE AND ATHENS, GA COTTON AND RAYON FIBER AS MANUFACTURED IN QUEBEC CANADA KOB 051 (ELASTIC POLYESTER FABRIC) AS MANUFACTURED IN WOLFSTEIN, GERMANY MYCOPHENOLATE SODIUM AS MANUFACTURED IN BANGALORE KARNATAKA INDIA AND WINNIPEG MANITOBA CANADA LAMINATED TUBES AS MANUFACTURED IN GUANGZHOU PR CHINA 127A78 ARTIFICIAL CHERRY FLAVOR AS MANUFACTURED IN NORTH AURORA IL 148A41 ARTIFICIAL GRAPE FLAVOR AS MANUFACTURED IN NORTH AURORA IL MANNOSE TRIFLATE AS MANUFACTURED IN BEER SHEVA ISRAEL GP531T DRUG SUBSTANCE AS MANUFACTURED IN TAKAOKA CITY TOYAMA JAPAN ARIPIPRAZOLE AS MANUFACTURED IN ANDHRA PRADESH INDIA LIFORCELL ACF PRODUCT LINE NOVEL EXCIPIENT AS MANUFACTURED IN LOGAN UTAH FOR LIFEBLOOD MEDICAL INC SUPER REFINED PEANUT OIL NF AS MANUFACTURED IN MILL HALL PA CONTAINER AND CLOSURE AS MANUFACTURED IN GYEONGGI DO SOUTH KOREA JSP92476 DRUG SUBSTANCE AS MANUFACTURED IN BALTIMORE MD 6 AMINO PENICILLANIC ACID AS MANUFACTURED IN SHANXI PROVINCE CHINA STERILE MANUFACTURING FACILITY OF AUROBINDO PHARMA LIMITED UNIT VI LOCATED IN HYDERABAD INDIA NAPROXEN SODIUM USP NON STERILE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH INDIA 716252 NATURAL FLAVOR MODULATOR (SWEET) FMT AS MANUFACTURED IN CLARK NJ 716253 NATURAL FLAVOR MODULATOR (SWEET) FMT AS MANUFACTURED IN CLARK NJ TRAVOPROST ACTIVE DRUG SUBSTANCE AS MANUFACTURED IN GRAFTON WI LAMINATED TUBES AS MANUFACTURED IN DANVILLE VA PLASTIC TUBES AS MANUFACTURED IN DANVILLE VA FASTLAB NAF CASSETTE PACK AS MANUFACTURED IN RADEBERG, GERMANY FOR GE HEALTHCARE INC SEMI SYNTHETIC PACLITAXEL DRUG SUBSTANCE AS MANUFACTURED IN KUNMING PR CHINA GUAIFENESIN AS MANUFACTURED IN ZHEJIANG CHINA TIGECYCLINE HYDROCHLORIDE AS MANUFACTURED IN KUNDL TYROL AUSTRIA (R)-[1-(4 CHLOROPHENYL) PHENYL METHYL-1-PIPERAZINE] AS MANUFACTURED IN GUJARAT INDIA

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4Q2012EXCEL DMF# 22843 A 22844 A 22845 A 22846 A 22847 22848 A 22849 A 22850 A 22851 22852 22853 A 22854 22855 A 22856 22857 22858 22859 A 22860 A 22861 22862 22863 22864 A 22865 A 22866 22867 22868 A 22869 A 22870 22871 A A II II 6/16/2009 6/16/2009 FORMOSA LABORATORIES INC HEMMO PHARMACEUTICALS PVT LTD II 6/12/2009 CHR OLESEN SYNTHESIS AS PRAMIPEXOLE AS PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN HVIDOVRE DENMARK COLESEVELAM HYDROCHLORIDE AS MANUFACTURED IN TAOYUAN TAIWAN DESMOPRESSIN ACETATE AS MANUFACTURED IN DIST THANE INDIA P A II III 6/5/2009 6/15/2009 *** PENDING FILING REVIEW *** CADILA PHARMACEUTICALS LTD HEINKE TECHNOLOGY INC DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA II 6/12/2009 AUROBINDO PHARMA LTD A A A II II II II 8/26/2009 8/11/2009 8/31/2009 8/26/2009 II 8/28/2009 ORCHID CHEMICALS AND PHARMACEUTICALS LTD CADILA PHARMACEUTICALS LTD CADILA PHARMACEUTICALS LTD JUBILANT LIFE SCIENCES LTD JUBILANT LIFE SCIENCES LTD A A A II II II II 8/27/2009 6/10/2009 6/10/2009 6/30/2010 SUN PHARMACEUTICAL INDUSTRIES LTD ZHUHAI UNITED LABORATORIES CO LTD UNITED LABORATORIES CHENGDU CO LTD CHEMWERTH INC BUPRENORPHINE HYDROCHLORIDE USP (ESUB) AMPICILLIN TRIHYDRATE AS MANUFACTURED IN ZHUHAI GD CHINA A II II 6/22/2009 8/14/2009 SUN PHARMACEUTICAL INDUSTRIES LTD CHEMWERTH INC A A II II II 6/10/2009 6/12/2009 6/12/2009 VIWIT PHARMACEUTICAL CO LTD HARMAN FINOCHEM LTD APOTEX PHARMACHEM INDIA PVT LTD IV 6/3/2009 UNGERER AND CO IV 6/3/2009 UNGERER AND CO A IV IV 6/5/2009 6/10/2009 NUSIL TECHNOLOGY LLC SYMRISE INC II 6/9/2009 AARTI INDUSTRIES LTD II 6/8/2009 MITSUI NORIN CO LTD V 6/8/2009 WEST PHARMACEUTICAL SERVICES INC STATUS Type SUBMIT DATE II 6/8/2009 HOLDER CATALENT PHARMA SOLUTIONS LLC SUBJECT

4Q2012

ESTRADIOL VAGINAL SOFT GELATIN CAPSULES AS MANUFACTURED IN ST PETERSBURG FL WESTAR READY TO USE (RU) GAMMA IRRADIATED ELASTOMERS LOCATED IN ESCHWEILER, GERMANY POLYPHENON E CAPSULES AS MANUFACTURED IN KANSAS CITY MO FOR MITSUI NORIN CO LTD BENAZEPRIL HYDROCHLORIDE POLYMORPH B AS MANUFACTURED IN MAHARASHTRA INDIA DDU 4330 SILICONE ELASTOMER AS MANUFACTURED IN CARPINTERIA CA 993270 NATURAL & ARTIFICIAL FLAVOR CHERRY TYPE 612082 AS MANUFACTURED IN TETERBORO NJ AND BRANCHBURG NJ ARTIFICIAL GRAPE CONCENTRATE FLAVOR FP-876 AS MANUFACTURED IN BETHLEHEM PA ARTIFICIAL CHERRY CONCENTRATE FLAVOR FS 3931 AS MANUFACTURED IN BETHLEHEM PA BRINZOLAMIDE USP AS MANUFACTURED IN SHANGHAI CHINA OXYBUTYNIN CHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA RISPERIDONE AS MANUFACTURED IN KARNATAKA INDIA FOR APOTEX PHARMACHEM INC EPINASTINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT INDIA INTERMEDIATE 6 OF ARGATROBAN (ARGA 6) (ESUB) AS MANUFACTURED BY TIANJIN WEIJIE PHARMACEUTICAL CO., LTD. IN TIANJIN, CHINA FOR CHEMWERTH, INC.

7-AMINOCEPHALOSPORANIC ACID (7-ACA) AS MANUFACTURED IN SICHUAN PR CHINA TOPOTECAN HCL (ESUB) AS MANUFACTURED IN SICHUAN PROVINCE PR OF CHINA FOR CHEMWERTH INC PRAMIPEXOLE DIHYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA OLMESARTAN MEDOXOMIL (ESUB) AS MANUFACTURED IN GUJARAT INDIA ATOMOXETINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT INDIA EPROSARTAN MESYLATE (ESUB) AS MANUFACTURED IN KARNATAKA INDIA ESCITALOPRAM OXALATE (ESP PROCESS) (ESUB) AS MANUFACTURED IN KARNATAKA INDIA PIOGLITAZONE HYDROCHLORIDE (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA

PACKAGING, VAGINAL SUPPOSITORY APPLICATOR AS MANUFACTURED IN LINCOLN NE

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4Q2012EXCEL DMF# 22872 A 22873 22874 22875 22876 22877 22878 C 22879 A 22880 22881 22882 A 22883 22884 22885 A 22886 A 22887 A 22888 A 22889 A 22890 22891 A 22892 22893 A 22894 A 22895 A 22896 A 22897 A 22898 22899 A A II III 5/22/2009 6/19/2009 II 6/19/2009 V 5/11/2009 INDUSTRIAL TECHNOLOGY RESEARCH INSTITUTE SHOUGUANG FUKANG PHARMACEUTICAL CO LTD AUCTUS PHARMA LTD SCHOTT XINKANG PHARMACEUTICAL PACKAGING CO LTD III 6/24/2009 II 6/16/2009 TIANJIN YAGUANG HIGH TECH DEVELOPMENT CO KARL OTTO BRAUN GMBH AND CO KG A II II 6/24/2009 6/25/2009 SEQUENT SCIENTIFIC LTD MYLAN LABORATORIES LTD A IV IV 6/24/2009 6/18/2009 CARGILL INC ROBERTET FLAVORS INC REBIANA AS MANUFACTURED IN KUALA LUMPUR MALAYSIA FOR CARGILL INC II 6/24/2009 NEULAND LABORATORIES LTD II 7/1/2009 UNICHEM LABORATORIES LTD II 7/2/2009 UNICHEM LABORATORIES LTD II 6/30/2009 UNICHEM LABORATORIES LTD N A II II 6/19/2009 6/23/2009 NOT AN ASSIGNED NUMBER VIWIT PHARMACEUTICAL CO LTD EDISON PHARMACEUTICALS INC BORTEZOMIB AS MANUFACTURED IN SHANGHAI CHINA A A II II II 6/26/2009 6/22/2009 6/22/2009 IPCA LABORATORIES LTD SUMITOMO CHEMICAL CO LTD TEVA PHARMACEUTICAL INDUSTRIES LTD III 6/10/2009 INJECTA AMPOULES PVT LTD A A A P A III II 6/10/2009 6/18/2009 II III III 5/26/2009 6/16/2009 6/16/2009 CHANGZHOU AHK TECH INC FOAMEX INNOVATIONS OPERATING CO FXI FOAMEX INNOVATIONS INC *** PENDING FILING REVIEW *** POLYCINE GMBH TEVA PHARMACEUTICAL INDUSTRIES LTD INERTA 103 FILM AS MANUFACTURED IN SCHIFFWEILER GERMANY STATUS Type SUBMIT DATE II 6/17/2009 HOLDER ANSTO RADIOPHARMACEUTICALS SUBJECT

4Q2012

SODIUM MOLYBDATE (99MO) FISSION SOLUTION AS MANUFACTURED IN LUCAS HEIGHTS, AUSTRALIA AMIFOSTINE AS MANUFACTURED JIANGSU PROVINCE PR CHINA FLM158 AS MANUFACTURED IN FORT WAYNE IN FLM159 AS MANUFACTURED IN FORT WAYNE IN

DROSPIRENONE AS MANUFACTURED IN SANTHIA VC ITALY AND RHO MI ITALY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD NEUTRAL GLASS AMPOULES USP TYPE I AS MANUFACTURED IN DAMAN (UNION TERRITORY OF INDIA) INDIA PYRIMETHAMINE (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA R BACLOFEN AS MANUFACTURED IN OKAYAMA JAPAN RAMELTEON AS MANUFACTURED IN BEER SHEVA ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD

ALPHA TOCOTRIENOL QUINONE (EPI-743) AS MANUFACTURED IN HUNZENSCHWIL SWITZERLAND FOR EDISON PHARMACEUTICALS INC MEMANTINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN DISTRICT DHAR (MP) INDIA BUPRENORPHINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN DHATA ROHA DIST RAIGAD INDIA QUETIAPINE HEMIFUMARATE (ESUB) AS MANUFACTURED IN DISTRICT DHAR (MP) INDIA ARIPIPRAZOLE (ANHYDROUS FORM - B) AS MANUFACTURED IN ANDHRA PRADESH INDIA

SPRAY DRIED CITRUS ICE TYPE NATURAL FLAVOR NV-25829 AS MANUFACTURED IN PISCATAWAY NJ SUCCINYLCHOLINE CHLORIDE AS MANUFACTURED IN KARNATAKA INDIA VALACYCLOVIR HYDROCHLORIDE (VCR) AS MANUFACTURED IN ANDHRA PRADESH INDIA SODIUM MONOFLUOROPHOSPHATE AS MANUFACTURED IN TIANJIN PR CHINA KOB 053 (BI-ELASTIC POLYESTER FABRIC) AS MANUFACTURED IN WOLFSTEIN, GERMANY CELL MANUFACTURING FACILITY LOCATED AT CHUTUNG HSINCHU TAIWAN OMEPRAZOLE AS MANUFACTURED IN SHOUGUANG CITY PR CHINA LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA TUBING BOROSILICATE GLASS (TYPE I, USP) CONTAINERS FOR PARENTERAL PREPARATIONS AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA

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4Q2012EXCEL DMF# 22900 22901 A 22902 22903 22904 22905 22906 22907 A 22908 22909 22910 22911 A 22912 A 22913 22914 A 22915 22916 A 22917 22918 22919 22920 A 22921 I 22922 22923 22924 A 22925 22926 22927 22928 A 22929 A 22930 22931 22932 A A A II II II 7/8/2009 7/8/2009 7/6/2009 CADILA HEALTHCARE LTD SIGNA SA DE CV EUTICALS SPA III 7/1/2009 SPL DESSECANTES LTDA A A A II II II III 7/8/2009 7/8/2009 7/7/2009 7/1/2009 A A II II II 6/30/2009 6/15/2009 7/6/2009 APICORE LLC OLON SPA ACTAVIS PHARMA MANUFACTURING PRIVATE LTD CADILA HEALTHCARE LTD SEQUENT SCIENTIFIC LTD CAMBREX PROFARMACO MILANO SRL AMPACET CORP II 7/1/2009 SYMED LABS LTD A A A III II II III 6/23/2009 6/15/2009 7/2/2009 6/19/2009 ROLLS PACK PVT LTD ACS DOBFAR SPA CADILA HEALTHCARE LTD LAMINADOS FACARLYTE SA DE CV A II III 6/30/2009 6/29/2009 CAMBRIDGE MAJOR LABS INC AMPACET CORP I II III 6/29/2009 6/30/2009 TEVA PHARMACEUTICAL INDUSTRIES LTD APTAR RADOLFZELL GMBH II 6/29/2009 TEVA PHARMACEUTICAL INDUSTRIES LTD A A A III II II II 6/26/2009 6/26/2009 8/10/2009 7/15/2009 A A A A A II II II II II II 6/25/2009 6/23/2009 6/29/2009 6/22/2009 6/29/2009 6/24/2009 STATUS Type SUBMIT DATE A II II 6/25/2009 3/31/2009 HOLDER MACLEODS PHARMACEUTICALS LTD ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD PROCOS SPA ALKERMES GAINESVILLE LLC SYMBIOTEC PHARMALAB LTD EMCURE PHARMACEUTICALS LTD TORRENT PHARMACEUTICALS LTD FIDIA FARMACEUTICI SPA DIVISIONE SOLMAG TRUDELL MEDICAL INTERNATIONAL ALBEMARLE CORP IPCA LABORATORIES LTD IPCA LABORATORIES LTD SUBJECT ESCITALOPRAM OXALATE AS MANUFACTURED IN GUJARAT INDIA DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA

4Q2012

CHLOPHEDIANOL HYDROCHLORIDE AS MANUFACTURED IN CAMERI (NO) ITALY ELN-CT-105G AS MANUFACTURED IN GAINESVILLE GA METHYLPREDNISOLONE HEMISUCCINATE AS MANUFACTURED IN INDORE INDIA CARMUSTINE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA NEBIVOLOL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA RIFAMYCIN SV SODUM SALT AS MANUFACTURED IN MULAZZANO (LO) ITALY PACKAGING COMPONENT AS MANUFACTURED IN ONTARIO CANADA AMIFOSTINE AS MANUFACTURED IN SOUTH HAVEN MI SULFADOXINE (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA RISPERIDONE (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA ELETRIPTAN HYDROBROMIDE AS MANUFACTURED IN BEER SHEVA ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD MUPIROCIN CALCIUM DIHYDRATE AS MANUFACTURED IN ZAGREB CROATIA CARTRIDGE PUMP SYSTEMS (CPS) AS MANUFACTURED IN RADOLFZELL, GERMANY AND EIGELTINGEN, GERMANY FP-098 AS MANUFACTURED IN GERMANTOWN WI 173409 SMC GREEN PE MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA AND HEATH OH TAILOR MADE POLY BAGS AS MANUFACTURED IN MUMBAI INDIA ARGININE (STERILE BULK) AS MANUFACTURED IN MILANO ITALY AZELASTINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA GASKET TYPE PACKAGING MATERIALS AS MANUFACTURED IN TLALNEPANTLA ESTADO DE MEXICO, MEXICO SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA BORTEZOMIB (ESUB) AS MANUFACTURED IN SOMERSET NJ DAPTOMYCIN AS MANUFACTURED IN TORINO ITALY PIOGLITAZONE HYDROCHLORIDE (NON-STERILE) DRUG SUBSTANCE AS MANUFACTURED IN TAMIL NADU INDIA PREGABALIN AS MANUFACTURED IN GUJARAT INDIA OSELTAMIVIR PHOSPHATE AS MANUFACTURED IN KARNATAKA INDIA RALOXIFENE HYDROCHLORIDE AS MANUFACTURED IN MILAN ITALY 110402 WHITE PE MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA AND HEATH OH DESTAMP - DESICCANT TAMPER-EVIDENT CLOSURES AS MANUFACTURED IN ATIBAIA BRAZIL AMLODIPINE BESYLATE USP AS MANUFACTURED IN GUJARAT INDIA LAMIVUDINE AS MANUFACTURED IN TOLUCA MEXICO FOR APOTEX PHARMACHEM INC ERGOTAMINE TARTRATE USP/EP AS MANUFACTURED IN MILAN ITALY

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4Q2012EXCEL DMF# 22933 22934 A 22935 22936 22937 22938 22939 22940 22941 22942 22943 A 22944 22945 A 22946 A 22947 22948 22949 22950 A 22951 22952 22953 A 22954 22955 A 22956 22957 A 22958 A 22959 A 22960 22961 A 22962 22963 22964 A A A II II II 7/21/2009 7/20/2009 7/21/2009 GLAND PHARMA LTD AARTI INDUSTRIES LTD LEK PHARMACEUTICALS DD A III III 7/16/2009 7/16/2009 REXAM PHARMA PACKAGING INDIA P LTD REXAM PHARMA PACKAGING INDIA P LTD III 7/21/2009 HUHTAMAKI RONSBERG II 7/15/2009 APICORE LLC A II II 7/18/2009 7/17/2009 A II II 7/17/2009 7/20/2009 AARTI INDUSTRIES LTD CHANGZHOU QIANHONG BIO PHARMA CO LTD HIKAL LTD TEVA PHARMACEUTICAL INDUSTRIES LTD A A III II II 7/17/2009 7/17/2009 8/26/2009 SHINKO CHEMICAL CO LTD GLENMARK GENERICS LTD USV LIMITED A A A II IV II III 7/15/2009 7/15/2009 7/16/2009 7/14/2009 SANOFI CHIMIE BASF SE SIGNA SA DE CV AMPACET CORP III 6/29/2009 A II II 9/18/2009 7/14/2009 LUPIN LTD HY GRO CHEMICALS PHARMATEK PRIVATE LTD GERRESHEIMER ZARAGOZA SA A A A A A A A A II II II III II II II IV II 7/10/2009 6/25/2009 7/13/2009 7/9/2009 6/30/2009 7/13/2009 7/10/2009 7/14/2009 9/29/2009 SCINOPHARM TAIWAN LTD CTX LIFE SCIENCES PVT LTD DR REDDYS LABORATORIES LTD AMPACET CORP JOHNSON MATTHEY INC SHASUN PHARMACEUTICALS LTD RA CHEM PHARMA LTD FONA INTERNATIONAL INC LUPIN LTD STATUS Type SUBMIT DATE A II III 7/8/2009 7/8/2009 HOLDER SRIKEM LABORATORIES PVT LTD AMPACET CORP SUBJECT MECLIZINE HYDROCHLORIDE USP AS MANUFACTURED IN MUMBAI INDIA

4Q2012

191029 FDA BLACK PE MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA AND HEATH OH ARGATROBAN AS MANUFACTURED IN TAINAN COUNTY TAIWAN ROC METOPROLOL TARTRATE USP (ROUTE-I) AS MANUFACTURED IN GUJARAT INDIA UDENAFIL AS MANUFACTURED IN ANDHRA PRADESH INDIA 181092 K AMBER 092 AS MANUFACTURED IN RAYONG THAILAND METHYLPHENIDATE FREE BASE AS MANUFACTURED IN WEST DEPTFORD NJ SEVELAMER CARBONATE AS MANUFACTURED IN CUDDALORE INDIA DOXAZOSIN MESYLATE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA 852.0093U FRUIT PUNCH FLAVOR NAT WONF AS MANUFACTURED IN GENEVA IL 7-AMINO-3-VINYL 3-CEPHEM-4-CARBOXYLIC ACID(7-AVCA) (ESUB) AS MANUFACTURED IN GUJARAT INDIA EMTRICITABINE AS MANUFACTURED IN MAHARASHTRA,INDIA D OXYPHENE BASE (AN INTERMEDIATE FOR DEXTROPROPOXYPHENE HCI USP) ANDHRA PRADESH INDIA PLASTIC BOTTLES AND DROPPER BOTTLE SYSTEMS AS MANUFACTURED IN EPILA SPAIN AND MASALVES (VALENCIA) SPAIN TRIAMCINOLONE ACETONIDE AS MANUFACTURED IN VERTOLAYE FRANCE LUDIPRESS AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY ACYCLOVIR AS MANUFACTURED IN TOLUCA MEXICO FOR APOTEX PHARMACHEM INC 167378 SMC BLUE PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA AND HEATH OH EYEDROP CONTAINER UE-5 AS MANUFACTURED IN ISHIKAWA JAPAN FROVATRIPTAN SUCCINATE MONOHYDRATE AS MANUFACTURED IN GUJARAT INDIA NARATRIPTAN HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA CAPECITABINE AS MANUFACTURED IN MAHARASHTRA INDIA HEPARIN SODIUM USP (NON STERILE BULK) AS MANUFACTURED IN JIANGSU CHINA VENLAFAXINE HYDROCHLORIDE API AS MANUFACTURED IN BANGALORE INDIA ARMODAFINIL AS MANUFACTURED IN BEER SHEVA ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD FELBAMATE(ESUB) AS MANUFACTURED BY APTUIT LAURUS PRIVATE LIMITED IN ANDHRA PRADESH INDIA FOR APICORE LLC TUBE LAMINATES AS MANUFACTURED BY LAMINOR SA IN RIO GRANDE DO NORTE BRAZIL AND HUHTAMAKI RONSBERG IN RONSBERG, GERMANY RISPHARM CONTAINER CLOSURE SYSTEM AS MANUFACTURED IN BANGALORE INDIA DOUBLE SAFE CONTAINER CLOSURE SYSTEM AS MANUFACTURED IN BANGALORE INDIA CISATRACURIUM BESYLATE (ESUB) AS MANUFACTURED IN HYDERABAD INDIA DESONIDE AS MANUFACTURED IN MAHARASHTRA INDIA AMLODIPINE BESYLATE (PROCESS 2) AS MANUFACTURED IN MENGES SLOVENIA

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4Q2012EXCEL DMF# 22965 A 22966 22967 22968 22969 22970 A 22971 22972 22973 22974 22975 22976 A 22977 22978 22979 22980 22981 22982 22983 A 22984 A 22985 22986 A 22987 A 22988 22989 22990 22991 A 22992 A 22993 A 22994 22995 22996 A A A II II II 7/27/2009 7/28/2009 7/30/2009 V 7/22/2009 MICROTROL STERILISATION SERVICES PVT LTD APICORE LLC SEQUENT SCIENTIFIC LTD APOTEX PHARMACHEM INDIA PVT LTD MICROTROL STERILISATION SERVICES PVT LTD LOCATED IN GURGAON INDIA II 7/28/2009 CILAG AG A A A IV IV II III 7/27/2009 7/22/2009 8/3/2009 7/28/2009 KAFRIT INDUSTRIES 1993 LTD CRODA JAPAN KK LUPIN LTD PRESSPART GMBH CO KG II 7/29/2009 R TECH UENO LTD N V 7/24/2009 NOT AN ASSIGNED NUMBER CATALENT BELGIUM SA III 7/21/2009 A A A A A A II IV III II III II II 7/22/2009 7/23/2009 7/22/2009 7/22/2009 7/24/2009 7/21/2009 7/24/2009 HAUDONG MEDICINE CO LTD FONA INTERNATIONAL INC KRAIBURG TPE GMBH AND CO KG AARTI INDUSTRIES LTD GERRESHEIMER WILDEN AG SCHWEIZ LONZEAL PHARMACEUTICALS CO LTD MYCOPHENOLATE MOFETIL AS MANUFACTURED IN ZHEJIANG CHINA 825.0259U CHERRY FLAVOR NAT WONF AS MANUFACTURED IN GENEVA IL A A A A A II II II II II II 7/21/2009 7/21/2009 7/22/2009 7/22/2009 7/16/2009 4/21/2009 AARTI INDUSTRIES LTD VALDEPHARM NEULAND LABORATORIES LTD INTERQUIM SA JOINT STOCK CO GRINDEKS P P A P II 7/18/2009 II 8/19/2009 STATUS Type SUBMIT DATE IV 7/20/2009 HOLDER AMCOL HEALTH AND BEAUTY SOLUTIONS INC *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** CIPLA LTD *** PENDING FILING REVIEW *** AUROBINDO PHARMA LTD SUBJECT POLY PORE E100 POLYMER (ALLYL METHACRYLATES CROSSPOLYMER) AS MANUFACTURED IN LAFAYETTE LA

4Q2012

ARFORMOTEROL TARTRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA OMEPRAZOLE MAGNESIUM USP (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA MERCAPTOPURINE AS MANUFACTURED IN MAHARASHTRA INDIA ESTRADIOL HEMIHYDRATE AS MANUFACTURED IN VAL DE REUIL FRANCE SALMETEROL XINAFOATE PH EUR AS MANUFACTURED IN ANDHRA PRADESH INDIA RIVASTIGMINE AS MANUFACTURED IN BARCELONA SPAIN DROPERIDOL USP AS MANUFACTURED IN RIGA LV LATVIA

HEBEI HUARONG PHARMACEUTICAL CO LTD COBAMAMIDE AS MANUFACTURED IN HEBEI CHINA

THERMOLAST R M TM#MED AS MANUFACTURED IN WALDKRAIBURG GERMANY FLUTICASONE PROPIONATE USP AS MANUFACTURED IN MAHARASHTRA INDIA SPIROMAX INHALER AS MANUFACTURED IN KUSSNACHT SWITZERLAND LAMIVUDINE AS MANUFACTURED IN SHIJIAZHUANG CHINA

ACTAVIS PHARMA MANUFACTURING ARMODAFINIL (NON STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL PRIVATE LTD NADU INDIA ST GOBAIN PERFORMANCE PLASTICS CORP F1435 AS MANUFACTURED IN POESTENKILL NY

PROCEDURES FOR STERILE OPERATIONS IN CATALENT BELGIUM LOCATED IN BRUSSELS BELGIUM UNOPROSTONE ISOPROPYL OPHTHALMIC SOLUTION 0.15% AS MANUFACTURED IN SANDA HYOGO JAPAN MB CC 12720LD WHITE AS MANUFACTURED IN MP NEGEV ISRAEL SUPER REFINED CRODAMOL IPM UP LQ (JP) AS MANUFACTURED IN SHIGA JAPAN LEVOFLOXACIN HEMIHYDRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA ALUMINIUM ALLOY METERED DOSE INHALER CONTAINERS (CANS) INTERNALLY COATED WITH EPOXY PHENOLIC RESIN AS MANUFACTURED IN MARSBERG (BREDELAR), GERMANY NALTREXONE DRUG SUBSTANCE AS MANUFACTURED IN SCHAFFHAUSEN SWITZERLAND

FLUDROCORTISONE ACETATE USP (ESUB) AS MANUFACTURED IN SOMERSET NJ ARTEMETHER AS MANUFACTURED IN KARNATAKA INDIA TOLTERODINE TARTRATE AS MANUFACTURED IN KARNATAKA INDIA FOR APOTEX PHARMACHEM INC Page

697

4Q2012EXCEL DMF# 22997 22998 A 22999 23000 23001 A 23002 A 23003 A 23004 23005 A 23006 23007 A 23008 A 23009 23010 A 23011 23012 23013 23014 23015 23016 A 23017 23018 23019 23020 23021 23022 23023 A 23024 A 23025 A 23026 A IV 7/29/2009 SYMRISE GBMH CO KG IV 8/10/2009 II 8/3/2009 A A A A A A II II II II II II II 5/20/2009 5/20/2009 5/20/2009 5/20/2009 5/20/2009 5/20/2009 8/3/2009 A A A C A III II II II II II 8/4/2009 8/5/2009 10/26/2009 7/31/2009 7/23/2009 8/7/2009 NOVEX POLYFILMS PVT LTD HETERO LABS LTD CHATTEM CHEMICALS INC CTX LIFE SCIENCES PVT LTD CTX LIFE SCIENCES PVT LTD MALLADI DRUGS AND PHARMACEUTICALS LTD VIPOR CHEMICALS PRIVATE LTD VIPOR CHEMICALS PRIVATE LTD VIPOR CHEMICALS PRIVATE LTD VIPOR CHEMICALS PRIVATE LTD VIPOR CHEMICALS PRIVATE LTD VIPOR CHEMICALS PRIVATE LTD ERREDUE SPA INNOVATIVE CHEMICAL AND LIFE ERREDUE SPA INNOVATIVE CHEMICAL AND LIFE CAPSUGEL A II III 7/31/2009 8/4/2009 SYN TECH CHEM AND PHARM CO LTD ST GOBAIN PERFORMANCE PLASTICS II 8/4/2009 A II II 8/3/2009 8/3/2009 A II II 8/3/2009 7/27/2009 EUTICALS SPA DISHMAN PHARMACEUTICALS AND CHEMICALS LTD EXPLORA LABORATORIES SA BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG APOTEX PHARMACHEM INDIA PVT LTD II 7/30/2009 MEGAFINE PHARMA P LTD II 6/16/2009 CARDINAL HEALTH 414 LLC A A II II II 7/31/2009 6/12/2009 7/31/2009 CADILA HEALTHCARE LTD CENWAY PHARMACEUTICALS CO LTD CADILA HEALTHCARE LTD STATUS Type SUBMIT DATE A II II 7/31/2009 9/23/2009 HOLDER AARTI DRUGS LTD CHATTEM CHEMICALS INC SUBJECT

4Q2012

RIVASTIGMINE HYDROGEN TARTRATE AS MANUFACTURED IN MAHARASHTRA INDIA D-METHYLPHENIDATE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN CHATTANOOGA, TENNESSEE MESALAMINE USP AS MANUFACTURED IN GUJARAT INDIA 10 DABIII AS MANUFACTURED IN TIANJIN PR CHINA ATORVASTATIN CALCIUM (CRYSTALLINE FORM I) AS MANUFACTURED IN GUJARAT INDIA FLUOROMISONIDAZOLE F18 INJECTION([18F]FMISO) AS MANUFACTURED IN WOBURN MA, SEATTLE WA, BELTSVILLE MD, VAN NUYS CA AND COLUMBUS OH MIRTAZAPINE HEMIHYDRATE USP (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN NASHIK INDIA RIBAVIRIN AS MANUFACTURED IN CASALETTO LODIGIANO ITALY GLIMEPIRIDE AS MANUFACTURED IN GUJARAT INDIA FLUDARABINE PHOSPHATE AS MANUFACTURED IN MENDRISIO SWITZERLAND PHENYLEPHRINE HYDROCHLORIDE 150 MESH AS MANUFACTURED IN INGELHEIM AM RHEIN, GERMANY DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN BANGALORE KARNATAKA INDIA FOR APOTEX PHARMACHEM INC TIMOLOL MALEATE AS MANUFACTURED IN TAIWAN ROC POLYESTER FILM C/1/S WITH 7754 SILICONE RELEASE COATING AS MANUFACTURED WORCESTER MA TAILOR MADE POLYTHENE BAGS AS MANUFACTURED IN MAHARASHTRA INDIA SIMVASTATIN AS MANUFACTURED IN ANDHRA PRADESH INDIA FENTANYL CITRATE USP (ESUB) AS MANUFACTURED IN CHATTANOOGA TN ACETAZOLAMIDE USP AS MANUFACTURED IN GUJARAT INDIA CHLOROTHIAZIDE USP AS MANUFACTURED IN GUJARAT INDIA D THREO RITALINIC ACID HYDROCHLORIDE AS MANUFACTURED IN TAMIL NADU INDIA CHLORHEXIDINE BASE AS MANUFACTURED IN GUJARAT INDIA CHLORHEXIDINE ACETATE BP AS MANUFACTURED IN GUJARAT INDIA CHLORHEXIDINE GLUCONATE SOLUTION BP AS MANUFACTURED IN GUJARAT INDIA CHLORHEXIDINE HYDROCHLORIDE BP AS MANUFACTURED IN GUJARAT INDIA CETRIMIDE BP AS MANUFACTURED IN GUJARAT INDIA CALAMINE BP AS MANUFACTURED IN GUJARAT INDIA RIBAVIRIN USP EP AS MANUFACTURED IN ISSO (BG) ITALY RITALINIC ACID AS MANUFACTURED IN ISSO (BG) ITALY EMPTY HARD CAPSULES FROM HYPROMELLOSE (HYDROXYPROPYLMETHYLCELLULOSE) VCAPS PLUS AS MANUFACTURED IN COLMAR FRANCE FOR CAPSUGEL DIV PIFIZER INC 301877 EVOGRAN NATURAL & ARTIFICIAL GRAPEFRUIT FLAVOR AS MANUFACTURED IN HOLZMINDEN, GERMANY

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4Q2012EXCEL DMF# 23027 23028 23029 23030 23031 A 23032 A 23033 A 23034 A 23035 A 23036 23037 23038 23039 23040 23041 23042 A 23043 23044 C 23045 A 23046 A 23047 23048 23049 23050 23051 A 23052 A 23053 A 23054 C 23055 23056 A A III III 8/10/2009 8/10/2009 RAVIRAJ FOILS LTD RAVIRAJ FOILS LTD II 8/19/2009 TEVA PHARMACEUTICAL INDUSTRIES LTD IV 8/13/2009 UNGERER AND CO II 8/19/2009 A A A A II II II IV II 8/10/2009 9/30/2009 8/17/2009 8/17/2009 3/5/2009 ALEMBIC PHARMACEUTICALS LTD LUPIN LTD INTERQUIM SA FONA INTERNATIONAL INC ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD DSM ANTI INFECTIVES BV III 8/13/2009 TEKNOR COLOR CO III 8/13/2009 P II 8/4/2009 *** PENDING FILING REVIEW *** FIDIA FARMACEUTICI SPA DIVISIONE SOLMAG MWV CALMAR GMBH A A A A A A II III II II II II II 8/9/2009 8/10/2009 8/11/2009 8/13/2009 8/14/2009 8/14/2009 8/14/2009 HIKMA PHARMACEUTICALS COLORMATRIX CORP AARTI INDUSTRIES LTD FORMOSA LABORATORIES INC UQUIFA MEXICO SA DE CV YONSUNG FINE CHEMICALS CO LTD YONSUNG FINE CHEMICALS CO LTD III 8/13/2009 SABIC PETROCHEMICALS BV III 8/13/2009 SABIC PETROCHEMICALS BV II 7/31/2009 ALP PHARM BEIJING CO LTD II 7/30/2009 ALP PHARM BEIJING CO LTD STATUS Type SUBMIT DATE A A A A IV II II II II 7/29/2009 8/12/2009 7/30/2009 7/31/2009 7/31/2009 HOLDER SYMRISE GBMH CO KG AMOLI ORGANICS PVT LTD YUKI GOSEI KOGYO CO LTD ALP PHARM BEIJING CO LTD ALP PHARM BEIJING CO LTD SUBJECT

4Q2012

163592 MENTHOL L SPRAY DRIED AS MANUFACTURED IN HOLZMINDEN, GERMANY DICLOFENAC POTASSIUM AS MANUFACTURED IN GUJARAT INDIA BETA-ALANINE AS MANUFACTURED IN FUKUSHIMA JAPAN BECLOMETHASONE DIPROPIONATE AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA BROMFENAC SODIUM HYDRATE AS MANUFACTURED IN ZHANGQIU MINGSHUI JINAN SHANDONG CHINA FOR ALP PHARM BEIJING CO LTD NEPAFENAC AS MANUFACTURED IN JIANGSU PROVINCE CHINA FOR ALP PHARM BEIJING CO LTD VARENICLINE TARTRATE AS MANUFACTURED IN JIANGSU PROVINCE CHINA FOR ALP PHARM BEIJING CO LTD SABIC HDPE PCG40053 00900 AS MANUFACTURED IN AI GELEEN THE NETHERLANDS FOR SABIC PETROCHEMICALS BV SABIC HDPE PCG5421 00900 AS MANUFACTURED IN AI GELEEN THE NETHERLANDS FOR SABIC PETROCHEMICALS BV ZOLEDRONIC ACID MONOHYDRATE AS MANUFACTURED IN AMMAN JORDAN PACKAGING MATERIAL AS MANUFACTURED IN BEREA OHIO AZATHIOPRINE USP AS MANUFACTURED IN MAHARASHTRA INDIA SEVELAMER CARBONATE AS MANUFACTURED IN TAOYUAN TAIWAN PYRANTEL PAMOATE AS MANUFACTURED IN MORELOS MEXICO MISOPROSTOL AS MANUFACTURED IN HWASEONG SI GYEONGGI DO KOREA MISOPROSTOL HPMC 1% DISPERSION AS MANUFACTURED IN HWASEONG SI GYCONGGI DO KOREA VALGANCYCLOVIR HYDROCHLORIDE AMORPHOUS AS MANUFACTURED IN MULAZZANO (LO) ITALY PRESERVATIVE FREE PUMP PFP SPRAYER MEDICAL DEVICE AS MANUFACTURED IN HEMER, GERMANY 70671LCP ORANGE 716 50:1 AS MANUFACTURED IN HENDERSON KY AND JACKSONVILLE TX FENOFIBRIC ACID CHOLINE SALT AS MANUFACTURED IN GUJARAT INDIA CHOLINE FENOFIBRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN BARCELONA SPAIN 889.276 PEACH-MINT FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA IL DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA ATORVASTATIN CALCIUM CRYSTALLINE AND MICRONIZED AS MANUFACTURED IN HARYANA INDIA FOR DSM ANTI-INFECTIVES BV NATURAL AND ARTIFICIAL BUBBLEGUM FLAVOR FQ-5511 AS MANUFACTURED IN BETHLEHEM PA DOCETAXEL AS MANUFACTURED IN LERMA EDO DE MEXICO AND SANTHIA (VC) ITALY FOR TEVA PHARMACUETICAL INDUSTRIES LTD ALUMINIUM FOIL CONTAINER AS MANUFACTURED IN GUJARAT INDIA ALUMINIUM LIDDING FOIL (COATED/PRINTED) AS MANUFACTURED IN GUJARAT INDIA

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4Q2012EXCEL DMF# 23057 A 23058 A 23059 A 23060 23061 A 23062 A 23063 A 23064 A 23065 I 23066 23067 A 23068 A 23069 23070 23071 A 23072 A 23073 A 23074 A 23075 A 23076 23077 A 23078 23079 A 23080 23081 23082 A A A II IV III 8/31/2009 9/3/2009 8/31/2009 UQUIFA MEXICO SA DE CV FONA INTERNATIONAL INC LOPAREX LLC PYRANTEL TARTRATE ZEOLEX AS MANUFACTURED IN MORELOS MEXICO 829.0013U FONATECH CLOUDING BLEND AS MANUFACTURED IN GENEVA IL A II II 8/28/2009 8/28/2009 JUNGBUNZLAUER LADENBURG GMBH APOTEX PHARMACHEM INC A II II 8/26/2009 8/28/2009 II 8/20/2009 DISHMAN PHARMACEUTICALS AND CHEMICALS LTD FARCHEMIA SRL TEVA PHARMACEUTICAL INDUSTRIES LTD IV 8/1/2009 CRODA INC III 8/4/2009 II 8/17/2009 A A II II IV 8/19/2009 8/10/2009 8/25/2009 POLYDRUG LABORATORIES PVT LTD VIRUPAKSHA ORGANICS PVT LTD AVANTOR PERFORMANCE MATERIALS INC II 8/24/2009 A II II 8/26/2009 8/21/2009 II 8/24/2009 II 8/20/2009 II 8/19/2009 II 8/21/2009 A III II 8/21/2009 8/20/2009 CODING PRODUCTS II 8/20/2009 ALDRICH CHEMICAL CO ISOTEC FACILITY III 8/10/2009 RAVIRAJ FOILS LTD STATUS Type SUBMIT DATE III 8/10/2009 HOLDER RAVIRAJ FOILS LTD SUBJECT

4Q2012

ALUMINIUM BLISTER FOIL (BARE/COATED/PRINTED) AS MANUFACTURED IN GUJARAT INDIA ALUMINIUM STRIP FOIL (BARE/LAMINATED/PRINTED) AS MANUFACTURED IN GUJARAT INDIA CORTISOL-9, 11, 12, 12-D4, FOR EARLY CLINICAL TRIALS AS MANUFACTURED IN MIAMISBURG OH TTR-77190 AS MANUFACTURED IN KALKASKA MI

ZHEJIANG HISUN PHARMACEUTICAL CO LTD MYCOPHENOLIC ACID NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT AS MANUFACTURED IN ZHEJIANG PROVINCE PR CHINA AMRI RENSSELAER INC SUB ALBANY TARTARIC ACID NF DRUG SUBSTANCE AS MANUFACTURED IN RENSSELAER NY MOLECULAR RESEARCH INC FLEMING LABORATORIES LTD CYCLOBENZAPRINE HYDROCHLORIDE USP BULK AS MANUFACTURED IN ANDHRA PRADESH INDIA BIOPHARM GMBH RHGDF-5 (RECOMBINANT HUMAN GROWTH/DIFFERENTIATION FACTOR 5) AS MANUFACTURED IN KAWAGOE CITY SAITAMA JAPAN FOR BIOPHARM GMBH HANGZHOU ZHONGMEI HUADONG MYCOPHENOLIC ACID AS MANUFACTURED IN HANGZHOU CHINA PHARMACEUTICAL CO LTD SMS PHARMACEUTICALS LTD RIZATRIPTAN BENZOATE AS MANUFACTURED IN ANDHRA PRADESH INDIA ACTAVIS PHARMA MANUFACTURING PRIVATE LTD AUROBINDO PHARMA LTD SILDENAFIL CITRATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU INDIA REPAGLINIDE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA CHLOROBUTANOL (HEMIHYDRATE) AS MANUFACTURED IN MAHARASHTRA INDIA FEXOFENADINE HCL AS MANUFACTURED IN ANDHRA PRADESH INDIA PANEXCEA TM MHC300G (ESUB) AS MANUFACTURED IN NASIK MAHARASHTRA INDIA FOR AVANTOR PERFORMANCE MATERIALS INC

TANGSHAN SANXIN BIOCHEMICAL PRODUCT CHONDROITIN SULFATE SODIUM AS MANUFACTURED IN HEBEI PROVINCE PR CHINA CO LTD SSF PLASTICS INDIA PRIVATE LTD EYE EAR & NASAL DROPPER VIALS AND DRY SYRUP BOTTLE SET AS NANI DAMAN INDIA ARLACEL P135 (PEG 30 DIPOLYHYDROXYSTEARATE) AS MANUFACTURED IN NEW CASTLE DE OCTENIDINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA IMIPRAMINE PAMOATE AS MANUFACTURED IN TEVIGLIO (BG) ITALY DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN ZAGREB CROATIA AND PRIGORJE BRDOVECKO CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD CITRIC ACID AS MANUFACTURED IN LADENBURG, GERMANY SUMATRIPTAN SUCCINATE USP AS MANUFACTURED IN BRANTFORD ONTARIO CANADA

GRADE 45821 D 4.0 WH HDP U4195/000 AS MANUFACTURED IN IOWA CITY IA, EDEN NC, CULLMAN AL AND HAMMOND WI

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4Q2012EXCEL DMF# 23083 23084 C 23085 23086 23087 23088 23089 A 23090 A 23091 A 23092 A 23093 A 23094 A 23095 A 23096 A 23097 A 23098 23099 23100 A 23101 23102 A 23103 A 23104 23105 A 23106 23107 A 23108 A II 9/11/2009 A III II 9/14/2009 9/10/2009 PRO PALS INDUSTRIES LTD ZHEJIANG HISOAR PHARMACEUTICAL CO LTD ALEMBIC PHARMACEUTICALS LTD A IV II 9/11/2009 7/8/2009 SPI PHARMA INC NANDU CHEMICALS PVT LTD II 9/9/2009 CERBIOS PHARMA SA A II II 9/10/2009 9/4/2009 ZYFINE DIV CADILA HEALTHCARE LTD MEGAFINE PHARMA P LTD A A II IV II 9/8/2009 8/31/2009 9/9/2009 MERCK KGAA NECTAR LIFESCIENCES LTD SHASUN PHARMACEUTICALS LTD BORIC ACID AS MANUFACTURED IN FRANKFURTER STRASSE, GERMANY II 9/3/2009 II 8/6/2009 SAFC BIOSCIENCES INC II 7/31/2009 SAFC BIOSCIENCES INC II 7/31/2009 SAFC BIOSCIENCES INC II 7/31/2009 SAFC BIOSCIENCES INC II 7/31/2009 SAFC BIOSCIENCES INC II 7/31/2009 SAFC BIOSCIENCES INC II 7/31/2009 SAFC BIOSCIENCES INC A A A A II IV IV II II 9/4/2009 9/2/2009 9/2/2009 8/28/2009 7/31/2009 SEQUENT SCIENTIFIC LTD KOEL COLOURS PVT LTD KOEL COLOURS PVT LTD PARABOLIC DRUGS LTD SAFC BIOSCIENCES INC STATUS Type SUBMIT DATE A II II 9/3/2009 8/31/2009 HOLDER BASF PHARMACHEMIKALIEN GMBH CO KG AUROBINDO PHARMA LTD SUBJECT

4Q2012

PHENYLEPHRINE HYDROCHLORIDE AS MANUFACTURED IN MINDEN, GERMANY IRBESARTAN USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA STAVUDINE AS MANUFACTURED IN KARNATAKA INDIA LAKE COLOURS AS MANUFACTURED IN GUJARAT INDIA IRON OXIDE COLOURS AS MANUFACTURED IN GUJARAT INDIA CEFUROXIME ACID AS MANUFACTURED IN PUNJAB INDIA EX-CELL EBX GRO I, SERUM-FREE MEDIUM FOR EMBRYONIC STEM CELLS, W/O LGLUTAMINE, W/O PHENOL RED AS MANUFACTURED IN DENVER PA EX-CELL EBX GRO II, SERUM-FREE MEDIUM FOR EMBRYONIC STEM CELLS, W/O LGLUTAMINE AS MANUFACTURED IN DENVER PA EX-CELL EBX GRO I, SERUM-FREE MEDIUM FOR EMBRYONIC STEM CELLS, W/O LGLUTAMINE, W/O PHENOL RED, W/O SODIUM BICARBONATE AS MANUFACTURED IN DENVER PA EX-CELL CD CHO (63206 MODIFIED) CHO SERUM-FREE MEDIUM, CHEMICALLY DEFINED, W/500 MG/L DEXTRAN SULFATE, W/O L-GLUTAMINE, W/O HYPOXANTINE AS MANUFACTURED IN DENVER PA EX-CELL EBX GRO II, SERUM-FREE MEDIUM FOR EMBRYONIC STEM CELLS, W/O LGLUTAMINE, W/O SODIUM BICARBONATE AS MANUFACTURED IN DENVER PA EX-CELL CD CHO FUSION, ANIMAL-COMPONENT FREE, SERUM-FREE MEDIUM, CHEMICALLY DEFINED, W/O L-GLUTAMINE AS MANUFACTURED IN DENVER PA EX-CELL CD CHO FUSION, ANIMAL-COMPONENT FREE, SERUM-FREE MEDIUM, CHEMICALLY DEFINED, W/O L-GLUTAMINE, W/O SODIUM BICARBONATE AS MANUFACTURED IN DENVER PA EX-CELL CD HYDROLYSATE FUSION, ANIMAL COMPONENT FREE, CHEMICALLY-DEFINED LIQUID MEDIA, (PRODUCT NO. 14700C), DRY POWDER MEDIA (PRODUCT NO. 24700C) AS MANUFACTURED IN DENVER PA

ST GOBAIN PERFORMANCE PLASTICS CORP SANI-TECH ULTRA 50 SILICONE TUBING AS MANUFACTURED IN TAUNTON MA

HARD GELATIN CAPSULE SHELL AS MANUFACTURED IN DISTT SOLAN (HP) INDIA CARISOPRODOL AS MANUFACTURED IN CUDDALORE INDIA FOR SHASUN RESEARCH CENTRE OXALIPLATIN PH. EUR. AS MANUFACTURED IN GUJARAT INDIA VENLAFAXINE HYDROCHLORIDE (AMC ACETATE ROUTE) (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN NASHIK INDIA CALCIPOTRIENE ANHYDROUS DRUG SUBSTANCE AS MANUFACTURED IN BARBENGO SWITZERLAND ADVANTOL 300 AS MANUFACTURED IN GRAND HAVEN MI SODIUM CHLORIDE BP (PARENTERAL GRADE) AS MANUFACTURED IN BELUR DHARWAD INDIA FOAM LDPE LINER AS MANUFACTURED IN LAVAL QC CANADA KETO AS MANUFACTURED IN ZHEJIANG CHINA MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA

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4Q2012EXCEL DMF# 23109 A 23110 23111 A 23112 A 23113 A 23114 A 23115 A 23116 23117 23118 A 23119 23120 23121 23122 A 23123 23124 23125 A 23126 A 23127 I 23128 23129 23130 C 23131 23132 23133 23134 23135 23136 A 23137 A 23138 C II 9/24/2009 II 9/29/2009 A A A A A III II II II II II 9/24/2009 9/28/2009 9/28/2009 10/27/2009 9/28/2009 7/27/2009 AMERICHEM INC RELIABLE BIOPHARMACEUTICAL CORP ERREGIERRE SPA LUPIN LTD TAI HENG INDUSTRY CO LTD A A II II II 9/25/2009 10/7/2009 9/28/2009 DR REDDYS LABORATORIES LTD JUBILANT LIFE SCIENCES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD III 9/18/2009 AMPACET CORP II 10/6/2009 BASF PHARMA CALLANISH LTD A A II II II 9/23/2009 9/23/2009 9/22/2009 SHILPA MEDICARE LTD SEQUENT SCIENTIFIC LTD ION EXCHANGE INDIA LTD A A A II II II III 9/15/2009 9/16/2009 9/21/2009 11/25/2008 MEISSNER FILTRATION PRODUCTS INC MYLAN LABORATORIES LTD RAKS PHARMA PVT LTD EMS CHEMIE NORTH AMERICA INC A A II II II 9/10/2009 9/18/2009 9/16/2009 MEISSNER FILTRATION PRODUCTS INC CATALENT PHARMA SOLUTIONS LLC FARMABIOS S P A II 9/30/2009 LUPIN LTD III 9/15/2009 IV 9/9/2009 IV 9/9/2009 A II IV 9/14/2009 9/8/2009 STATUS Type SUBMIT DATE II 9/14/2009 HOLDER HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD TORRENT PHARMACEUTICALS LTD KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE ELM PLASTIC GMBH SUBJECT SIROLIMUS AS MANUFACTURED IN HANGZHOU CHINA ESOMEPRAZOLE MAGNESIUM AS MANUFACTURED IN GUJARAT INDIA

4Q2012

5X00158 LUBRITOSE AN AS MANUFACTURED IN BLUE EARTH MN FOR KERRY BIOFUNCTIONAL INGREDIENTS WL10400330 SHEFFIELD TABLETTING SYSTEM DISINTEQUIK AS MANUFACTURED IN ROTHSCHILD WI FOR KERRY BIOFUNCTIONAL INGREDIENTS WL10400331 SHEFFIELD TABLETTING SYSTEM DISINTEQUIK MCC AS MANUFACTURED IN ROTHSCHILD WI FOR KERRY BIOFUNCTIONAL INGREDIENTS PLASTIC DOSING PIPETTES (SHORT FORM) AS MANUFACTURED IN DUDELDORF, GERMANY CLINDAMYCIN PALMITATE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA TEPOFLEX BIOCONTAINERS AS MANUFACTURED IN CAMARILLO CA PROCARDIA SOFTGELS 10 MG (NIFEDIPINE) AS MANUFACTURED IN ST PETERSBURG FL BETAMETHASONE DIPROPIONATE MICRONIZED AS MANUFACTURED IN GROPELLO CAIROLI (PV) ITALY EVERLUX FILTER CARTRIDGES AS MANUFACTURED IN CAMARILLO CA ESOMEPRAZOLE MAGNESIUM AS MANUFACTURED IN ANDHRA PRADESH INDIA TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA GRILAMID TR 60 NATURAL AS MANUFACTURED IN REICHENAUERSTRASSE DOMAT/EMS FOR EMS CHEMIE (NORTH AMERICA) INC ANASTROZOLE AS MANUFACTURED IN KARNATAKA INDIA NEVIRAPINE ANHYDROUS AS MANUFACTURED IN KARNATAKA INDIA CALCIUM POLYSTYRENE SULPHONATE BP 2007 (INDION 404) AS MANUFACTURED IN GUJARAT INDIA DOCOSAHEXAENOIC ACID ETHYL ESTER (DHA 90 EE) (ESUB) AS MANUFACTURED IN SCOTLAND UNITED KINGDOM 190826 HP BLACK PE MB AS MANUFACTURED BY AMPACET EUROPE SA IN WINDHOF GRAND DUCHE DE LUXEMBOURG FOR AMPACET CORPORATION GRANISETRON AS MANUFACTURED IN ANDHRA PRADESH INDIA PALIPERIDONE (ESUB) AS MANUFACTURED IN KARNATAKA INDIA CISATRACURIUM BESYLATE AS MANUFACTURED IN SANTHIA (VC) ITALY AND RHO (MI) ITALY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD 46538 CD4 WHITE COLORANT AS MANUFACTURED IN CUYAHOGA FALLS OH DEXMEDETOMIDINE HCI AS MANUFACTURED IN ST LOUIS MO DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN BERGAMO ITALY ARMODAFINIL (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA

DERIVADOS QUIMICOS SA FINE CHEMICALS IPRATROPIUM BROMIDE AS MANUFACTURED MURCIA SPAIN ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN JIANGSU PROVINCE PR CHINA FOR TAI HENG INDUSTRY CO LTD JINAN JINDA PHARMACEUTICAL CHEMISTRY NITROFURAZONE AS MANUFACTURED IN SHANDONG PROVINCE CHINA CO LTD LAURUS LABS PRIVATE LTD DOCETAXEL ANHYDROUS AS MANUFACTURED IN ANDHRA PRADESH INDIA

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4Q2012EXCEL DMF# 23139 23140 23141 23142 23143 A 23144 23145 23146 23147 A 23148 23149 23150 A 23151 23152 A 23153 23154 23155 A 23156 A 23157 23158 23159 A 23160 23161 23162 A 23163 A 23164 23165 23166 A 23167 A 23168 A II 10/6/2009 ANUS LABORATORIES LTD II 10/9/2009 A A II II IV 10/8/2009 10/5/2009 10/8/2009 EMCURE PHARMACEUTICALS LTD JOST CHEMICAL CO II 10/7/2009 A A II II II 10/5/2009 10/9/2009 10/7/2009 MYLAN LABORATORIES LTD AARTI DRUGS LTD CSPC WEISHENG PHARMACEUTICAL SHIJIAZHUANG CO LTD MACLEODS PHARMACEUTICALS LTD A A II II IV 9/30/2009 10/6/2009 10/5/2009 BIOVET JOINT STOCK CO FORMOSA LABORATORIES INC SYMRISE INC II 9/25/2009 ALP PHARM BEIJING CO LTD A A II II II 9/30/2009 9/25/2009 9/18/2009 NUTRA SPECIALITIES PRIVATE LTD DALIAN ZHEN AO BIO TECH CO LTD ALP PHARM BEIJING CO LTD A II IV 10/6/2009 9/29/2009 NISSAN CHEMICAL INDUSTRIES LTD HENKEL CORP A A II IV II 10/2/2009 10/6/2009 10/5/2009 HOVIONE FARMACIENCIA SA CAFOSA GUM SA SIGNA SA DE CV A A A II II II II 9/30/2009 9/30/2009 10/2/2009 9/29/2009 STATUS Type SUBMIT DATE A A A A II II III II II 10/1/2009 9/30/2009 9/30/2009 9/30/2009 9/25/2009 HOLDER SMS PHARMACEUTICALS LTD JOHNSON MATTHEY PHARMA SERVICES A SUNG PLASTIC IND CO LTD SANOFI AVENTIS CHIMIE ZHEJIANG CANDORLY PHARMACEUTICAL CO LTD MEDICHEM SA MEDICHEM SA AMINO CHEMICALS LTD WUHAN WUYAO PHARMACEUTICAL CO LTD SUBJECT IMATINIB MESYLATE AS MANUFACTURED IN ANDHRA PRADESH INDIA 4116.E AS MANUFACTURED IN DEVENS MA CONTAINER & CLOSURE AS MANUFACTURED IN KYONGKI DO KOREA NALOXONE HYDROCHLORIDE 350 AS MANUFACTURED IN ARAMON FRANCE

4Q2012

(R) -9-[2-(PHOSPHONMETHOXY)PROPYL]ADENINE AN INTERMEDIATE FOR TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN ZHEJIANG PROVINCE PR CHINA LOXAPINE BASE AS MANUFACTURED IN GIRONA SPAIN MED-201750/E AS MANUFACTURED IN GIRONA SPAIN (R)-MODAFINIL AS MANUFACTURED IN MARSA MALTA CHLOROPROCAINE HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN WUHAN CHINA IOHEXOL AS MANUFACTURED IN LINHAI PARK CHINA FOR HOVIONE FARMACIENCIA SA HIG PWD-01 AS MANUFACTURED IN BARBERA DEL VALLES SPAIN VALSARTAN USP AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO FOR APOTEX PHARMACHEM INC NTC-801F AS MANUFACTURED IN YAMAGUCHI JAPAN DURO-TAK 87-611A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY NC OLMESARTAN MEDOXOMIL AS MANUFACTURED IN ANDHRA PRADESH INDIA ADENOSINE 5' -MONOPHOSPHATE FREE ACID AS MANUFACTURED IN DALIAN CHINA ERGOCALCIFEROL USP AS MANUFACTURED IN SICHUAN PROVINCE CHINA FOR ALP PHARM BEIJING CO LTD D-PENICILLAMINE USP AS MANUFACTURED IN SICHUAN CHINA FOR ALP PHARM BEIJING CO LTD TESTOSTERONE AS MANUFACTURED IN PESHTERA BULGARIA TEMOZOLOMIDE AS MANUFACTURED IN TAOYUAN TAIWAN 695292 EVOGLASS NATURAL & ARTIFICIAL FLAVOR CHERRY TYPE AS MANUFACTURED IN TETERBORO NJ AND BRANCHBURG NJ TEMAZEPAM USP AS MANUFACTURED IN ANDHRA PRADESH INDIA CELECOXIB AS MANUFACTURED IN MAHARASHTRA INDIA ASCORBIC ACID (VITAMIN C) AS MANUFACTURED IN HEBEI PROVINCE CHINA PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN GUJARAT INDIA SEVELAMER CARBONATE AS MANUFACTURED IN MAHARASHTRA INDIA POTASSIUM SULFATE AS MANUFACTURED IN ST LOUIS MO

ARMARK AUTHENTICATION TECHNOLOGIES EXCIPIENT ON DOSE (EOD) GRADE COVERT MARKERS(CM): A PHYSICAL CHEMICAL LLC IDENTIFIER (PCID) UTILIZED FOR PHARMACEUTICAL BRAND PROTECTION AS MANUFACTURED IN GLEN ROCK PA ACS DOBFAR SPA CEFTAROLINE FOSAMIL STERILE DRUG SUBSTANCE AS MANUFACTURED IN MILANO ITALY CIS (+) HYDROXY LACTAM AS MANUFACTURED IN ANDHRA PRADESH INDIA FOR ANUS LABORATORIES LIMITED

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4Q2012EXCEL DMF# 23169 A 23170 23171 23172 23173 A 23174 A 23175 23176 A 23177 23178 A 23179 23180 23181 23182 A 23183 C 23184 23185 A 23186 A 23187 23188 A 23189 A 23190 A 23191 23192 23193 23194 23195 A 23196 23197 A A II IV 10/18/2009 10/14/2009 YONEZAWA HAMARI CHEMICALS LTD SURETY LABORATORIES INC A A A A II II II II III 10/20/2009 10/14/2009 10/16/2009 10/19/2009 10/20/2009 II 9/30/2009 LABORATORIO OPOTERAPICO ARGENTINO SA AMOLI ORGANICS PVT LTD UNIMARK REMEDIES LTD NOVUS FINE CHEMICALS LLC CHOONGWAE PHARMA CORP TUBETTIFICIO M FAVIA SRL II 7/31/2009 A IV II 10/16/2009 9/30/2009 II 10/15/2009 AMCOL HEALTH AND BEAUTY SOLUTIONS INC BASF SE LABORATORIO OPOTERAPICO ARGENTINO SA SAFC BIOSCIENCES INC A II II 10/16/2009 7/31/2009 EMCURE PHARMACEUTICALS LTD SAFC BIOSCIENCES INC II 10/16/2009 TEVA PHARMACEUTICAL INDUSTRIES LTD A A A II II II III 10/13/2009 10/13/2009 10/15/2009 10/14/2009 A II II 10/15/2009 10/14/2009 CRYSTAL PHARMA SAU ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD RAKS PHARMA PVT LTD EUROGENTEC SA CHOONGWAE PHARMA CORP BAYER MATERIALSCIENCE LLC A II III 10/7/2009 11/11/2009 EUTICALS SPA WEENER EMPIRE PLASTICS LTD II 10/9/2009 AUROBINDO PHARMA LTD A A A II II II II 10/14/2009 10/5/2009 9/22/2009 10/7/2009 STATUS Type SUBMIT DATE II 9/30/2009 HOLDER CHONGQING CARE LIFE PHARMACEUTICAL CO LTD AMOLI ORGANICS PVT LTD ION EXCHANGE INDIA LTD GLAND PHARMA LTD GLAND PHARMA LTD SUBJECT

4Q2012

ALENDRONATE SODIUM NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING PR CHINA CARBAMAZEPINE AS MANUFACTURED IN GUJARAT INDIA CHOLESTYRAMINE RESIN USP (INDION 454) AS MANUFACTURED IN GUJARAT INDIA DEXRAZOXANE (ESUB) AS MANUFACTURED IN HYDERABAD ANDHRA PRADESH INDIA TIROFIBAN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN HYDERABAD ANDHRA PRADESH, INDIA TORSEMIDE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA LITHIUM CARBONATE PHARMA GRADE AS MANUFACTURED IN LODI ITALY HIGH DENSITY POLYETHYLENE BOTTLES (ESUB) AS MANUFACTURED IN SILVASSA (UNION TERRITORY OF D&NH) INDIA NESTORONE AS MANUFACTURED IN BOECILLO (VALLADOLID) SPAIN DONEPEZIL HYDROCHLORIDE (PROCESS II) AS MANUFACTURED IN ZHEJIANG CHINA AZATHIOPRINE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA PRODUCTION OF PLASMID DNA AS MANUFACTURED IN SERAING BELGIUM CILASTATIN ACID AS MANUFACTURED IN GYEONGGI-DO REPUBLIC OF KOREA MAKROLON DP1-1869 AND MAKROLON AM2428 RESINS AS MANUFACTURED IN HEBRON OH ERLOTINIB HCL AS MANUFACTURED IN LERMA ESTADO DE MEXICO, MEXICO FOR TEVA PHARMACEUTICAL INDUSTRIES LTD EMTRICITABINE AS MANUFACTURED IN MAHARASHTRA INDIA EX-CELL EBX? PRO-I SERUM-FREE MEDIUM FOR EMBRYONIC STEM CELLS W/O LGLUTAMINE W/O PHENOL RED W/O SODIUM BICARBONATE AS MANUFACTURED IN DENVER PA TRETINOIN 4% IN POLY-PORE POLYMER (TRETINOIN IN ALLYL METHACRYLATES CROSSPOLYMER) AS MANUFACTURED IN LAFAYETTE LA KOLLICOAT IR COATING SYSTEMS AS MANUFACTURED IN LUDWIGHAFEN, GERMANY THYROID USP POWDER F.S./THYROID 3 X USP POWDER AS MANUFACTURED IN BUENOS ARIES ARGENTINA EX-CELL EBX PRO I SERUM-FREE MEDIUM FOR EMBRYONIC STEM CELLS W/O LGLUTAMINE W/O PHENOL RED AS MANUFACTURED IN DENVER PA PANCREATIN 4 X USP POWDER/PANCREALIPASE USP POWDER AS MANUFACTURED IN BUENOS AIRES ARGENTINA OXCARBAZEPINE AS MANUFACTURED IN GUJARAT INDIA FLECAINIDE ACETATE USP (PROCESS B) AS MANUFACTURED IN GUJARAT INDIA ALPRAZOLAM (CIV) AS MANUFACTURED IN CARLSTADT NJ PNB-THIENAMYCIN IMINE AS MANUFACTURED IN GYEONGGI-DO REPUBLIC OF KOREA ALUMINIUM COLLAPSIBLE TUBES FOR DRUG PRODUCTS AS MANUFACTURED IN MILANO ITALY LULICONAZOLE AS MANUFACTURED IN YAMAGATA JAPAN SURFASIL 1520 AS MANUFACTURED IN CASSOPOLIS MI FOR SURETY LABORATORIES INC

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4Q2012EXCEL DMF# 23198 A 23199 A 23200 A 23201 A 23202 I 23203 I 23204 I 23205 23206 23207 23208 23209 A 23210 A 23211 A 23212 23213 A 23214 23215 23216 A 23217 A 23218 A 23219 A 23220 A 23221 23222 23223 A 23224 23225 A A II III 10/29/2009 10/23/2009 DELMAR CHEMICALS INC FOUR M PROPACK PVT LTD A A IV II II 10/29/2009 10/28/2009 10/29/2009 FONA INTERNATIONAL INC LEK PHARMACEUTICALS DD CHANGZHOU PHARMACEUTICAL FACTORY II 10/27/2009 II 10/20/2009 DISHMAN PHARMACEUTICALS AND CHEMICALS LTD EMCURE PHARMACEUTICALS LTD IV 10/23/2009 II 10/21/2009 A A II II II 10/21/2009 10/26/2009 10/21/2009 I II II 10/29/2009 10/26/2009 CSL BEHRING LLC CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD SIEGFRIED LTD HETERO DRUGS LTD SHANDONG NEW TIME PHARMACEUTICAL CO LTD SHANDONG NEW TIME PHARMACEUTICAL CO LTD HENKEL CORP ISCOMATRIX ADJUVANT (ESUB) AS MANUFACTURED IN BRADLEY IL TACROLIMUS SD20 AS MANUFACTURED IN SHU-LIN TAIPEI HSIEN TAIWAN II 10/10/2009 DALIAN ZHEN AO BIO TECH CO LTD III 10/5/2009 STOLZE UNION SRO A A A A II II II II II 10/20/2009 10/20/2009 10/20/2009 10/19/2009 10/12/2009 IV 10/6/2009 IV 10/6/2009 IV 10/6/2009 II 9/18/2009 HUBEI HUANGSHI SHIXING PHARMACEUTICAL CO LTD KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE TOMITA PHARMACEUTICAL CO LTD INALCO SPA SUVEN LIFE SCIENCES LTD CHEMI SPA ALP PHARM BEIJING CO LTD II 10/21/2009 ESTEVE QUIMICA SA II 11/16/2009 SUN PHARMACEUTICAL INDUSTRIES LTD STATUS Type SUBMIT DATE IV 10/14/2009 HOLDER SURETY LABORATORIES INC SUBJECT

4Q2012

SURFASIL 1511 AS MANUFACTURED IN CASSOPOLIS MI FOR SURETY LABORATORIES INC ESOMEPRAZOLE SODIUM (ESUB) AS MANUFACTURED IN GUJARAT INDIA DICLOFENAC SODIUM INJECTABLE GRADE/NON-STERILE AS MANUFACTURED IN CELRA (GIRONA) SPAIN DEXKETOPROFEN TROMETAMOL AS MANUFACTURED IN HUBEI PROVINCE PR CHINA 5X00138 SHEFFIELD COATING SYSTEM CM AS MANUFACTURED IN NORWICH NY 5X00139 SHEFFIELD COATING SYSTEM CM AS MANUFACTURED IN NORWICH NY 5X00140 SHEFFIELD COATING SYSTEM CM AS MANUFACTURED IN NORWICH NY MAGNESIUM OXIDE USP LIGHT POWDER AS MANUFACTURED IN TOKUSHIMA JAPAN GOS 95 AS MANUFACTURED IN PISTOIA ITALY ZOLMITRIPTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA BUPROPION HCL FV3307 AS MANUFACTURED IN PATRICA (FR) ITALY PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA FOR ALP PHARM BEIJING CO LTD GLASS PRIMARY PACKAGING AS MANUFACTURED IN HERMANOVA HUT CZECH REPUBLIC URIDINE 5' -MONOPHOSPHATE DISODIUM SALT AS MANUFACTURED IN DALIAN CHINA PC

NALTREXONE HYDROCHLORIDE AS MANUFACTURED IN ZOFINGEN SWITZERLAND RILUZOLE AS MANUFACTURED IN ANDHRA PRADESH INDIA DILUTED ISOSORBIDE MONONITRATE (60%) AS MANUFACTURED IN SHANDONG PROVINCE CHINA DILUTED ISOSORBIDE MONONITRATE (70%) AS MANUFACTURED IN SHANDONG PROVINCE PR CHINA DURO-TAK 87-612A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY NC OMEPRAZOLE AS MANUFACTURED IN GAJARAT INDIA IRINOTECAN HYDROCHLORIDE TRIHYDRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA 815.0033U BUBBLEGUM FLAVOR, ART AS MANUFACTURED IN GENEVA IL CASPOFUNGIN ACETATE AS MANUFACTURED IN MENGES SLOVENIA RSM (ROSUVASTATIN METHYL ESTER, ROSUVASTATIN CALCIUM INTERMEDIATE) AS MANUFACTURED IN JIANGSU PROVINCE CHINA SUCCINYLCHOLINE CHLORIDE AS MANUFACTURED IN QUEBEC CANADA BOTTLES AND CLOSURES AS MANUFACTURED IN HIMACHAL PRADESH INDIA

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4Q2012EXCEL DMF# 23226 A 23227 A 23228 A 23229 A 23230 A 23231 A 23232 A 23233 23234 23235 A 23236 A 23237 A 23238 A 23239 23240 23241 23242 A 23243 A 23244 A 23245 23246 A 23247 A 23248 A 23249 A 23250 23251 23252 A A A II II II 11/5/2009 11/4/2009 12/2/2009 II 11/9/2009 II 11/9/2009 II 11/5/2009 MALLADI DRUGS AND PHARMACEUTICALS LTD CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO LTD CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO LTD MOEHS IBERICA SL RA CHEM PHARMA LTD ACOM CORP (ADVANCED CENTER ONCOLOGY MACERATA) LORAZEPAM AS MANUFACTURED IN TAMIL NADU INDIA DINOPROST AS MANUFACTURED IN BUDAPEST HUNGARY MISOPROSTOL AS MANUFACTURED IN BUDAPEST HUNGARY FENOFIBRATE AS MANUFACTURED IN BARCELONA SPAIN LAMOTRIGINE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA SODIUM [124I] IODIDE (ESUB) AS MANUFACTURED IN MONTECOSARO ITALY A II II 12/24/2009 11/6/2009 LUPIN LTD PHARMACOSMOS AS II 11/2/2009 HAINAN POLY PHARMACEUTICAL CO LTD II 11/2/2009 HAINAN POLY PHARMACEUTICAL CO LTD A A A II II II II 11/2/2009 10/30/2009 11/2/2009 11/3/2009 FINE CHEMICALS CORP PTY LTD ZACH SYSTEM SPA AREVIPHARMA GMBH IPC PROCESS CENTER GMBH AND CO KG III 11/2/2009 TOPPAN PRINTING CO LTD II 10/23/2009 III 10/29/2009 HSIAO SUNG NON OXYGEN CHEMICAL CO LTD COVALENT LABORATORIES PRIVATE LTD A A II II II 4/7/2010 10/23/2009 10/30/2009 LUPIN LTD CADILA HEALTHCARE LTD MCGUFF PHARMACEUTICALS INC II 10/30/2009 GLAND PHARMA LTD III 10/30/2009 COLORS FOR PLASTICS INC III 10/30/2009 III 10/28/2009 HSIAO SUNG NON OXYGEN CHEMICAL CO LTD AMPACET CORP II 10/16/2009 CHANGZHOU AHK TECH INC II 10/23/2009 STATUS Type SUBMIT DATE II 10/29/2009 HOLDER RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA DAISO CO LTD SUBJECT PHENYTOIN AS MANUFACTURED IN COMPOVERDE DI APRILIA (LT) ITALY

4Q2012

DAISOGEL ODS SERIES CHEMICALLY MODIFIED SILICA GEL AS MANUFACTURED IN HYOGO JAPAN CLADRIBINE NON-STERILE BULK DRUG AS MANUFACTURED IN JIANGSU PROVINCE PR CHINA SORB OO - OXYGEN ABSORBERS AS MANUFACTURED IN TAICHUNG COUNTY TAIWAN AND JIANG SU PROV CHINA FOR HSIAO SUNG NON-OXYGEN CHEMICAL CO LTD 102837 DESICCANT PE MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA AND HEATH OH THERMOPLASTIC RESIN COLORANT MASTERBATCH R29213 RED AS MANUFACTURED IN ELK GROVE VILLAGE IL AND SPARTANBURG SC DEXMEDETOMEDINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN HYDERABAD INDIA DOXERCALCIFEROL (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ESCITALOPRAM OXALATE (FORM -1) AS MANUFACTURED IN GUJARAT INDIA ASCOR L 500 (ASCORBIC ACID INJECTION USP) AS MANUFACTURED IN SANTA ANA CA O-BUSTER OXYGEN ABSORBERS AS MANUFACTURED IN TAICHUNG COUNTY TAIWAN AND JIANG SU PROV. CHANG SHU CHINA CEFUROXIME AXETIL USP (CRYSTALLINE) AS MANUFACTURED IN ANDHRA PRADESH INDIA HP-3 PACKAGE FOR TRANSDERMAL DRUG DELIVERY PATCHES AS MANUFACTURED IN FUKUOKA JAPAN FOR TOPPAN PRINTING CO LTD ROPIVACAINE AS MANUFACTURED IN CAPE TOWN SOUTH AFRICA OLOPATADINE HYDROCHLORIDE AS MANUFACTURED IN LONIGO ITALY BISOPROLOL FUMARATE AS MANUFACTURED IN RADEBEUL, GERMANY IBUPROFEN DC100 (IBUPROFEN PH. EUR., GRANULATED) AS MANUFACTURED IN DRESDEN, GERMANY DICLOFENAC SODIUM EXTENDED RELEASE CAPSULES AS MANUFACTURED IN HAINAN PROVINCE CHINA THEOPHYLLINE EXTENDED RELEASE CAPSULES AS MANUFACTURED IN HAINAN PROVINCE CHINA RANOLAZINE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA 24% IRON ISOMALTOSIDE POWDER (ESUB) AS MANUFACTURED IN HOLBAEK DENMARK

Page 706

4Q2012EXCEL DMF# 23253 23254 23255 23256 23257 A 23258 A 23259 A 23260 A 23261 23262 A 23263 23264 23265 A 23266 23267 23268 A 23269 A 23270 23271 A 23272 23273 A 23274 23275 A 23276 A 23277 A 23278 23279 A 23280 23281 A A II II 11/16/2009 11/19/2009 A II II 11/16/2009 11/18/2009 BIOCON LTD LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LTD HIKMA PHARMACEUTICALS HARMAN FINOCHEM LTD III 11/16/2009 PACUR LLC II 11/24/2009 A II V 11/17/2009 12/16/2009 A II II 11/9/2009 10/27/2009 A II II 11/16/2009 11/4/2009 II 11/12/2009 A A III II II 11/12/2009 11/13/2009 11/13/2009 A A III II II 11/12/2009 11/11/2009 11/10/2009 A IV II 11/11/2009 10/28/2009 COREL PHARMACHEM ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD MYLAN TECHNOLOGIES INC CADILA HEALTHCARE LTD ACTAVIS PHARMA MANUFACTURING PRIVATE LTD ST GOBAIN PERFORMANCE PLASTICS FORMOSA LABORATORIES INC FIDIA FARMACEUTICI SPA DIVISIONE SOLMAG ACTAVIS PHARMA MANUFACTURING PRIVATE LTD SIFAVITOR SRL SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD S M HERBALS PVT LTD SHOUGUANG FUKANG PHARMACEUTICAL CO LTD HETERO DRUGS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD SUZHOU HOMESUN WANQING PHARMACEUTICAL CO LTD IV 11/12/2009 COREL PHARMACHEM IV 11/12/2009 COREL PHARMACHEM IV 11/11/2009 COREL PHARMACHEM STATUS Type SUBMIT DATE A A A A III II II II IV 11/5/2009 11/5/2009 11/11/2009 11/10/2009 11/12/2009 HOLDER PRESSPART NEMO UNIMARK REMEDIES LTD MSN LABORATORIES LTD DR REDDYS LABORATORIES LTD COREL PHARMACHEM SUBJECT PACKAGING MATERIAL AS MANUFACTURED IN TARRAGONA SPAIN

4Q2012

LANTHANUM CARBONATE OCTAHYDRATE AS MANUFACTURED IN GUJARAT INDIA BOSENTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA LOPINAVIR AS MANUFACTURED IN ANDHRA PRADESH INDIA ACRYFLOW L, '12-HYDROXY STEARATE AS MANUFACTURED IN DIST MEHSANA (NG) INDIA KYRON T-104, CROSS-LINKED POLYACRYLATE AS MANUFACTURED IN DIST MEHSANA (NG) INDIA ACRYSOL K-150, PROPERITARY MIXTURE AS MANUFACTURED IN DIST MEHSANA (NG) INDIA ACRYSOL EL-135, POLYOXYL 35 CASTOR OIL USP/NF AS MANUFACTURED IN DIST MEHSANA (NG) INDIA KYRON T-114, POLACRILLIC ACID AS MANUFACTURED IN DIST MEHSANA (NG) INDIA LAMOTRIGINE USP AS MANUFACTURED IN ZHEJIANG CHINA MEDIDERM 3900 AS MANUFACTURED IN ST ALBANS VT ATORVASTATIN CALCIUM (CRYSTALLINE) AS MANUFACTURED IN GUJARAT INDIA RIVASTIGMINE HYDROGEN TARTRATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU INDIA F1570 AND F1571 AS MANUFACTURED IN POESTENKILL NY CALCIPOTRIOL MONOHYDRATE AS MANUFACTURED IN TAOYUAN TAIWAN CHOLINE FENOFIBRATE AS MANUFACTURED IN MULAZZANO (LO) ITALY DARIFENACIN HYDROBROMIDE (NON STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU INDIA PROGUANIL HYDROCHLORIDE AS MANUFACTURED IN LODI ITALY EFAVIRENZ AS MANUFACTURED IN SHANGHAI CHINA 10 DEACETYLBACCATIN III AS MANUFACTURED IN RAJASTHAN INDIA METFORMIN HYDROCHLORIDE AS MANUFACTURED IN SHANDONG PROVINCE PR CHINA EPROSARTAN MESYLATE AS MANUFACTURED IN ANDHRA PRADESH INDIA STERILE PROCESSING DETAILS OF PHASE - 18 (ESUB) AS LOCATED IN ALATHUR KANCHEEPURAM DISTRICT INDIA MEROPENEM FOR INJECTION STERILE BULK (ESUB) AS MANUFACTURED IN JIANGSU PR CHINA PACKAGING MATERIAL (EXTRUDED PLASTIC SHEET MATERIALS) AS MANUFACTURED IN OSHKOSH WI PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN BANGALORE INDIA ACARBOSE AS MANUFACTURED IN GUANGDONG PROVINCE PR CHINA NICARDIPINE HYDROCHLORIDE AS MANUFACTURED IN AMMAN JORDAN FENOFIBRATE USP AS MANUFACTURED IN MAHARASHTRA INDIA

Page 707

4Q2012EXCEL DMF# 23282 A 23283 A 23284 23285 A 23286 23287 23288 23289 23290 23291 23292 A 23293 A 23294 A 23295 A 23296 I 23297 I 23298 I 23299 I 23300 23301 A 23302 23303 A 23304 A 23305 23306 A 23307 A II 11/24/2009 SANDOZ GMBH A II V 11/25/2009 11/21/2009 SANDOZ PRIVATE LTD SANDOZ PRIVATE LTD IMIPENEN STERILE AS MANUFACTURED IN MAHARASHTRA INDIA III 11/11/2009 TRUDELL MEDICAL INTERNATIONAL A II III 11/23/2009 11/20/2009 FLAMMA SPA FUJIMORI KOGYO CO LTD LOSARTAN POTASSIUM AS MANUFACTURED IN BERGAMO ITALY A II II 11/18/2009 11/4/2009 IV 11/10/2009 IV 11/10/2009 IV 11/10/2009 IV 11/10/2009 KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE ALEMBIC PHARMACEUTICALS LTD JIANGSU ZW PHARMACEUTICALS CO LTD II 12/29/2009 II 12/24/2009 II 12/28/2009 ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD A A A A A A III II II II IV II II 11/20/2009 11/20/2009 11/20/2009 11/20/2009 11/20/2009 12/15/2009 12/24/2009 TAKEUCHI PRESS INDUSTRIES CO LTD FRESENIUS KABI ANTI INFECTIVES SRL APICORE LLC RAKS PHARMA PVT LTD SYMRISE GMBH AND CO KG SUN PHARMACEUTICAL INDUSTRIES LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD A II II 12/9/2009 12/24/2009 TARO PHARMACEUTICAL INDUSTRIES LTD BIOSENSORS INTERNATIONAL II 4/9/2010 STATUS Type SUBMIT DATE II 11/16/2009 HOLDER CHANGZHOU SUNLIGHT PHARMACEUTICAL CO LTD IPCA LABORATORIES LTD SUBJECT

4Q2012

BENZOCAINE USP NON STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU PROVINCE CHINA HYDROXYZINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA MEPROBAMATE USP (ESUB) AS MANUFACTURED IN HAIFA BAY ISRAEL BIOLIMUS A9 ACTIVE PHARMACEUTICAL INGREDIENT (API) (ESUB) AS MANUFACTURED IN GUNMA JAPAN FOR BIOSENSORS INTERNATIONAL TAKEUCHI 4315F TUBE AS MANUFACTURED IN HYOGO JAPAN AMPICILLIN SODIUM STERILE AS MANUFACTURED IN VILLADOSE (ROVIGO) ITALY DISULFIRAM USP AS MANUFACTURED IN GUJARAT INDIA FOR APICORE LLC WARFARIN SODIUM CLATHRATE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA CYCLOPENTADECANOLIDE (CPD) AS MANUFACTURED IN HOLZMINDEN, GERMANY QUETIAPINE FUMARATE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA QUETIAPINE FUMARATE (NON STERILE BULK API) (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA SODIUM CARBONATE (STERILE) (ESUB) AS MANUFACTURED IN ALATHUR INDIA CEFTAZIDIME (STERILE) (ESUB) AS MANUFACTURED IN ALATHUR INDIA CEFTAZIDIME + SODIUM CARBONATE (STERILE BULK) (ESUB) AS MANUFACTURED IN TAMILNADU INDIA 5X00149 SHEFFIELD COATING SYSTEM WHITE S AS MANUFACTURED IN NORWICH NY 5X00161 SHEFFIELD COATING SYSTEM WHITE 03 AS MANUFACTURED IN NORWICH NY 5X00162 SHEFFIELD COATING SYSTEM CLEAR PG AS MANUFACTURED IN NORWICH NY 5X00169 SHEFFIELD COATING SYSTEM WHITE PG AS MANUFACTURED IN NORWICH NY ARIPIPRAZOLE AS MANUFACTURED IN GUJARAT INDIA 4-(TRIFLUOROMETHOXY) ANILINE AS MANUFACTURED IN JIANGSU PROVINCE PR CHINA

RELEASE LINER FILM FOR USE IN PATCHES TRANSDERMAL DRUG DELIVERY (FILMBYNA **E-5511 DG-2.5) AS MANUFACTURED IN SHIZUOKA PREF JAPAN TOP MOUNTED ACTUATION INDICATOR (TMAI) AS MANUFACTURED IN ONTARIO CANADA

STERILIZATION PROCESS VALIDATION INFORMATION FOR CARBAPENEM STERILE PRODUCTS LOCATED IN MAHARASHTRA INDIA CILASTATIN SODIUM STERILE AS MANUFACTURED IN LANGKAMPFEN AUSTRIA

Page 708

4Q2012EXCEL DMF# 23308 A 23309 23310 A 23311 23312 A 23313 A 23314 A 23315 23316 A 23317 A 23318 A 23319 A 23320 23321 23322 A 23323 23324 23325 A 23326 23327 A 23328 A 23329 23330 A 23331 A 23332 A 23333 A II 4/6/2010 LUPIN LTD II 12/3/2009 TEVA PHARMACEUTICAL INDUSTRIES LTD V 12/2/2009 FACTA FARMACEUTICI SPA A II II 11/30/2009 11/25/2009 EXCELLA GMBH NINGBO TEAM PHARMACEUTICAL CO LTD II 12/1/2009 A II II 12/1/2009 12/1/2009 APOTEX PHARMACHEM INC SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTD PHARMAZELL GMBH ANASTROZOLE USP AS MANUFACTURED IN ONTARIO CANADA ATENOLOL AS MANUFACTURED IN SHANGHAI PR CHINA P A II II 12/1/2009 12/1/2009 *** PENDING FILING REVIEW *** YMC CO LTD CILAG AG A I III II II 11/28/2009 12/10/2009 11/30/2009 ESSEL PROPACK LTD RANBAXY LABORATORIES LTD MYLAN LABORATORIES LTD II 11/1/2009 CHEMPACIFIC CORP III 11/24/2009 TOPPAN PRINTING CO LTD III 11/26/2009 FUJIMORI KOGYO CO LTD A II III 11/27/2009 10/7/2009 ITF CHEMICAL LTDA EMA PHARMACEUTICALS MOXIFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN BAHIA BRAZIL II 11/27/2009 II 11/24/2009 A II II 11/20/2009 11/25/2009 RPG LIFE SCIENCES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD HALOPERIDOL USP AS MANUFACTURED IN NAVI MUMBAI INDIA P II 12/10/2009 *** PENDING FILING REVIEW *** USV LIMITED ACITRETIN USP (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA STATUS Type SUBMIT DATE II 7/10/2010 HOLDER STAVO INDUSTRIES INC SUBJECT

4Q2012

PHARMACEUTICAL GRADE DEPTH TYPE FILTERS (ESUB) AS MANUFACTURED IN KINGSTON NY

CARVEDILOL PHOSPHATE AS MANUFACTURED IN NETANYA ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD SANDOZ PRIVATE LTD IMIPENEM AND CILASTATIN STERILE BLEND AS MANUFACTURED IN MAHARASHTRA INDIA PHARMACEUTICAL WORKS POLPHARMA SA ARIPIPRAZOLE AS MANUFACTURED IN STAROGARD GDANSKI POLAND

PACKAGING MATERIAL (13 & 20 MM COMBINATED PLASTIC ALUMINUM CAPS) AS MANUFACTURED IN LAILLY EN VAL FRANCE PLASTIC FILM FOR USE IN DRUG PRODUCT CONTAINER AS MANUFACTURED IN MIE PREFECTURE JAPAN HP-2 PACKAGE FOR TRANSDERMAL DRUG DELIVERY PATCHES AS MANUFACTURED IN FUKUOKA JAPAN FOR TOPPAN PRINTING CO LTD BGP32269 AS MANUFACTURED IN BALTIMORE MD AND ZHEJIANG CHINA FOR CHEMPACIFIC CORPORATION LAMINATED TUBES AS MANUFACTURED IN DADRA & NAGAR HAVELI INDIA LAMIVUDINE (DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN PUNJAB INDIA VALGANCICLOVIR HYDROCHLORIDE USP (CRYSTALLINE) AS MANUFACTURED IN ANDHRA PRADESH INDIA YMC BIOPRO SERIES AS MANUFACTURED IN ISHIKAWA JAPAN FOR YMC CO LTD NALTREXONE HYDROCHLORIDE AS MANUFACTURED IN SCHAFFHAUSEN SWITZERLAND

CARBAMAZEPINE (PROCESS II) AS MANUFACTURED IN RAUBLING FEDERAL REPUBLIC, GERMANY AZATHIOPRINE (ESUB) AS MANUFACTURED IN FEUCHT GERMANY ONDANSETRON HYDROCHLORIDE BULK FORM AS MANUFACTURED IN ZHEJIANG PROVINCE PR CHINA STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN TERAMO ITALY PALONOSETRON HYDROCHLORIDE FORM A AS MANUFACTURED IN OPAVA KOMAROV CZECH REPUBLIC FOR TEVA PHARMACEUTICAL INDUSTRIES LTD COLESEVELAM HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA

Page 709

4Q2012EXCEL DMF# 23334 A 23335 23336 A 23337 23338 23339 23340 A 23341 A 23342 A 23343 A 23344 A 23345 A 23346 A 23347 A 23348 A 23349 23350 A 23351 23352 23353 23354 23355 A 23356 A 23357 23358 A 23359 23360 A 23361 A II 11/30/2009 ZHEJIANG GARDEN BIOCHEMICAL HIGH TECH STOCK CO LTD A II II 12/7/2009 12/10/2009 A III II 12/7/2009 12/4/2009 ESSEL PROPACK LTD NORTH CHINA PHARMACEUTICAL HUASHENG CO LTD JOST CHEMICAL CO SANOFI AVENTIS DEUTSCHLAND GMBH III 12/1/2009 SIBO G DOO A A A A II III II II II 11/30/2009 12/4/2009 11/30/2009 12/4/2009 12/2/2009 ALEMBIC PHARMACEUTICALS LTD AMERICHEM INC CTX LIFE SCIENCES PVT LTD MYLAN LABORATORIES LTD SAFC BIOSCIENCES INC A II II 11/30/2009 12/8/2009 UNIMARK REMEDIES LTD GADOR SA III 11/15/2009 SURYAS OLDFORT PLASTICS PVT LTD II 12/7/2009 II 11/30/2009 II 11/30/2009 ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD SIGNA SA DE CV V 12/3/2009 II 11/30/2009 II 11/30/2009 ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD SANOFI AVENTIS DEUTSCHLAND GMBH II 11/28/2009 A A A II II II III 12/4/2009 2/20/2010 12/4/2009 12/3/2009 AIR LIQUIDE HEALTHCARE AMERICA CORP UNIMARK REMEDIES LTD EMCURE PHARMACEUTICALS LTD HPT HOCHWERTIGE PHARMATECHNIK GMBH CO KG QILU PHARMACEUTICAL CO LTD A II II 12/2/2009 12/4/2009 LONZA AG AIR LIQUIDE HEALTHCARE AMERICA CORP STATUS Type SUBMIT DATE IV 12/3/2009 HOLDER DAIDO CHEMICAL CORP SUBJECT SANGELOSE (HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER) AS MANUFACTURED IN OSAKA JAPAN VOCLOSPORIN (IE-001) AS MANUFACTURED IN VISP SWITZERLAND

4Q2012

80PPM NITROGEN DIOXIDE BALANCE OXYGEN AS MANUFACTURED IN PLUMSTEADVILLE PA 80PPM NITROGEN DIOXIDE BALANCE AIR AS MANUFACTURED IN PLUMSTEADVILLE PA PALIPERIDONE (ESUB) AS MANUFACTURED IN GUJARAT INDIA GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA HD-PE ROUND BOTTLE 35ML AS MANUFACTURED IN NEUHAUS A RWG, GERMANY PEMETREXED DISODIUM AS MANUFACTURED IN JINAN SHANDONG PROVINCE PEOPLES REPUBLIC OF CHINA PREGABALIN AS MANUFACTURED IN ZHEJIANG CHINA IMATINIB MESYLATE AS MANUFACTURED IN ZHEJIANG CHINA FRANKFURT H600 ASEPTIC PROCESSING FACILITY LOCATED IN FRANKFURT AM MAIN, GERMANY ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA RIVASTIGMINE TARTRATE AS MANUFACTURED IN ZHEJIANG CHINA IRBESARTAN USP AS MANUFACTURED IN TOLUCA MEXICO FOR APOTEX PHARMACHEM INC (API) LDPE BASED PLASTIC FILMS FOR PHARMACEUTICAL USE AS MANUFACTURED IN SILVASSA INDIA TOPIRAMATE USP (PROCESS A) AS MANUFACTURED IN GUJARAT INDIA SODIUM IBANDRONATE AS MANUFACTURED IN PILAR PROVINCIA DE BUENOS AIRES ARGENTINA QUETIAPINE FUMARATE AS MANUFACTURED IN GUJARAT INDIA 44225-CD5 BLUE COLORANT AS MANUFACTURED IN CUYAHOGA FALLS OH OXCARBAZEPINE (ROUTE-I) AS MANUFACTURED IN GUJARAT INDIA BOSENTAN AS MANUFACTURED IN MAHARASHTRA INDIA EX-CELL ANTIFOAM GAMMA IRRADIATED BY SER-TAIN PROCESS AS MANUFACTURED IN DENVER PA CHILD RESISTANT CLOSURE CRP-045-FP AS MANUFACTURED IN SKOFJA LOKA SLOVENIA EU LAMINATED TUBES AS MANUFACTURED IN GOA INDIA BACITRACIN ZINC NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN HEBEI CHINA POTASSIUM NITRATE AS MANUFACTURED IN ST LOUIS MO FEXOFENADINE HYDROCHLORIDE (MDL 16455 A) AS MANUFACTURED IN FRANKFURT AM MAIN, GERMANY CHOLECALCIFEROL AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA

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4Q2012EXCEL DMF# 23362 I 23363 A 23364 A 23365 23366 23367 23368 23369 A 23370 A 23371 A 23372 A 23373 A 23374 A 23375 A 23376 23377 23378 23379 A 23380 23381 A 23382 A 23383 23384 A 23385 23386 I 23387 23388 A A II II 12/18/2009 12/18/2009 SCINOPHARM TAIWAN LTD CHEMO IBERICA SA MADRID A II II 12/14/2009 12/21/2009 BACHEM SA MITSUBISHI TANABE PHARMA CORP A II V 12/17/2009 12/21/2009 II 12/17/2009 A II II 12/16/2009 12/17/2009 AMINO CHEMICALS LTD ACTAVIS PHARMA MANUFACTURING PRIVATE LTD ACTAVIS PHARMA MANUFACTURING PRIVATE LTD EVERLIGHT CHEMICAL INDUSTRIAL CORP SANDOZ GMBH A A A II III II II 12/15/2009 12/15/2009 12/16/2009 12/16/2009 SANOFI AVENTIS CHIMIE MANUFACTURE GENERALE DE JOINTS MGJ SHASUN PHARMACEUTICALS LTD HETERO DRUGS LTD II 12/8/2009 SCORA SA II 12/16/2009 GADOR SA II 11/23/2009 COVALENT LABORATORIES PRIVATE LTD II 12/15/2009 SRI KRISHNA DRUGS LTD III 12/3/2009 MARTIN SONTAG GMBH III 11/11/2009 STE PHARMAPACK SL A A A A II II II II II 12/8/2009 3/5/2010 12/14/2009 12/14/2009 1/6/2010 BIOCON LTD TARO PHARMACEUTICAL INDUSTRIES LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD BASF PHARMA CALLANISH LTD IV 12/7/2009 HENKEL CORP IV 12/7/2009 HENKEL CORP STATUS Type SUBMIT DATE II 12/11/2009 HOLDER CHATHAM BIOTEC LTD SUBJECT

4Q2012

SEMISYNTHETIC DOCETAXEL DRUG SUBSTANCE (API) AS MANUFACTURED IN SHANGHAI CHINA (MAINLAND) FOR CBL - CHATHAM BIOTEC LTD DURO-TAK 87-625A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY NC DURO-TAK 87-626A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY NC TACROLIMUS (PRODUCT CODE 8000255) AS MANUFACTURED IN BANGALORE INDIA MALATHION USP (ESUB) AS MANUFACTURED IN HAIFA BAY ISRAEL PALIPERIDONE AS MANUFACTURED IN ANDHRA PRADESH INDIA NEVIRAPINE ANHYDROUS USP (RAN) AS MANUFACTURED IN ANDHRA PRADESH INDIA OMEGA-3 ACID ETHYL ESTERS 90 (ESUB) AS MANUFACTURED IN ISLE OF LEWIS, SCOTLAND UK PLASTIC MOLDED BOTTLE ASSEMBLIES FOR PACKAGING AND DELIVERY OF PHARMACEUTICAL PRODUCTS AS MANUFACTURED IN TARRAGONA SPAIN CARTRIDGES FOR PHARMACEUTICAL USE AS MANUFACTURED IN ONOLZHEIM, GERMANY MECLIZINE HYDROCHLORIDE (ESUB) USP AS MANUFACTURED IN ANDHRA PRADESH INDIA 7-AMINO-3-VINYL-3-CEPHEM-4-CARBOXYLIC ACID (7-AVNA) AS MANUFACTURED IN ANDHRA PRADESH INDIA ZOLEDRONIC ACID AS MANUFACTURED IN PILAR PROVINCIA DE BUENOS AIRES ARGENTINA GRANULAR CALCIUM CARBONATE (SCORALITE DC AND SCORALITE LOW LEAD DC) AS MANUFACTURED IN CAFFIERS FRANCE RPR106721 - POMA (INTERMEDIATE) AS MANUFACTURED IN VERTOLAYE FRANCE CORESEAL LINERS AS MANUFACTURED IN CHAZAY D'AZERGUES FRANCE COLESEVELAM HYDROCHLORIDE AS MANUFACTURED IN CUDDALORE INDIA ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA DEXLANSOPRAZOLE AS MANUFACTURED IN MARSA MALTA ROSIGLITAZONE MALEATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU INDIA LEVOFLOXACIN HEMIHYDRATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU INDIA LUBIPROSTONE AS MANUFACTURED IN TAOYUAN HSIEN TAIWAN STERILIZATION PROCESS VALIDATION INFORMATION FOR THE STERILE CEPHALOSPORIN CRYSTALLIZATION PLANT LOCATED IN KUNDL TYROL AUSTRIA DORZOLAMIDE HYDROCHLORIDE AS MANUFACTURED IN VIONNAZ SWITZERLAND MT-7716 DRUG SUBSTANCE AS MANUFACTURED IN YAMAGUCHI JAPAN FOR MITSUBISHI TANABE PHARMA CORPORATION DECITABINE AS MANUFACTURED IN TAINAN COUNTY TAIWAN ROC SEVELAMER CARBONATE AS MANUFACTURED IN ZHEJIANG PROVINCE PR OF CHINA FOR CHEMO IBERIC SA MADRID

Page 711

4Q2012EXCEL DMF# 23389 A 23390 23391 23392 23393 A 23394 A 23395 A 23396 23397 C 23398 23399 23400 23401 A 23402 A 23403 23404 23405 23406 23407 A 23408 23409 23410 23411 23412 23413 23414 C 23415 23416 A 23417 A 23418 23419 A A II II 12/31/2009 6/30/2010 ACS DOBFAR SPA CHATTEM CHEMICALS INC II 12/28/2009 CHEMWERTH INC I II II 12/15/2009 12/22/2009 AANJANEYA LIFECARE LTD CHEMWERTH INC A A A A I I II II II II II II II 12/23/2009 12/29/2009 12/29/2009 12/29/2009 12/28/2009 12/29/2009 12/29/2009 THE SUZUKI MENTHOL CO LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD RANBAXY LABORATORIES LTD RANBAXY LABORATORIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD A A A A II II II II III 12/22/2009 12/14/2009 12/22/2009 12/16/2009 12/21/2009 SIEGFRIED USA INC CHEMISCHE FABRIK BERG GMBH POLYDRUG LABORATORIES PVT LTD CENWAY PHARMACEUTICALS CO LTD AMPACET CORP II 12/23/2009 A A A II II II II 3/12/2010 12/21/2009 12/15/2009 12/23/2009 LUPIN LTD FINE CHEMICALS CORP PTY LTD SYN TECH CHEM AND PHARM CO LTD ACTAVIS PHARMA MANUFACTURING PRIVATE LTD TEVA PHARMACEUTICAL INDUSTRIES LTD A II II 12/22/2009 1/12/2010 SRI KRISHNA DRUGS LTD LUPIN LTD V 12/18/2009 NANOINK INC III 12/21/2009 COIM USA INC A A A II III IV III 12/18/2009 12/18/2009 12/18/2009 12/18/2009 EUTICALS INC JSR CORP FONA INTERNATIONAL INC EI DUPONT DE NEMOURS INC STATUS Type SUBMIT DATE II 2/22/2010 HOLDER SUN PHARMACEUTICAL INDUSTRIES LTD SUBJECT

4Q2012

NALOXONE HYDROCHLORIDE DIHYDRATE USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA CHOLINE FENOFIBRATE DRUG SUBSTANCE AS MANUFACTURED IN SPRINGFIELD MO ARTON SERIES AS MANUFACTURED IN CHIBA JAPAN 856.0196U GRAPE FLAVOR ART AS MANUFACTURED IN GENEVA IL DUPONT APPEEL LIDDING SEALANT RESINS AS MANUFACTURED IN ORANGE TX, ONTARIO CANADA, ZWIJNDRECHT BELGIUM AND HIROSHIMA PREFECTURE JAPAN NOVACOTE NC-9170-23MAC WITH CO-REACTANT CA-350 PU AS MANUFACTURED IN WEST DEPTFORD NJ PHARMACEUTICAL BRAND PROTECTION AND ANTI-COUNTERFEITING INSTRUMENTATION AND PROCESS FOR HARD CAPSULES AS MANUFACTURED IN SKOKIE IL FUROSEMIDE USP (ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA DROSPIRENONE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA FOR LUPIN LIMITED IRBESARTAN USP (PROCESS B) (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA FCC-7280 AS MANUFACTURED IN CAPE TOWN, SOUTH AFRICA RABEPRAZOLE SODIUM AS MANUFACTURED IN HSIN-YING TAIWAN ROC RANOLAZINE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU INDIA LUBIPROSTONE AS MANUFACTURED IN ZAGREB CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD OXYMORPHONE HYDROCHLORIDE USP AS MANUFACTURED IN PENNSVILLE NJ PHENOBARBITAL USP AS MANUFACTURED IN BITTERFELD-WOLFEN, GERMANY FLUCONAZOLE AS MANUFACTURED IN MAHARASHTRA INDIA DOCETAXEL AS MANUFACTURED IN TIANJIN PR CHINA 603192-PT UVA PET MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA AND HEATH OH L-MENTHOL USP/JP AS MANUFACTURED IN KOBE JAPAN VORINOSTAT AS MANUFACTURED IN MAHARASHTRA INDIA LENALIDOMIDE AS MANUFACTURED IN MAHARASHTRA INDIA LETROZOLE USP AS MANUFACTURED IN MAHARASHTRA INDIA ENTACAPONE AS MANUFACTURED IN PUNJAB INDIA TROSPIUM CHLORIDE (NON-STERILE BULK) AS MANUFACTURED IN PUNJAB INDIA SUNITINIB MALATE AS MANUFACTURED IN MILAN ITALY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD QUININE SULPHATE USP DRUG SUBSTANCE AS MANUFACTURED IN MAHAD INDIA AZACITIDINE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA FOR CHEMWERTH INC PEMETREXED DISODIUM NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA FOR CHEMWERTH INC AMPA AS MANUFACTURED IN MILANO ITALY OXYCODONE HYDROCHLORIDE, USP (ESUB) AS MANUFACTURED IN CHATTANOOGA TN

Page 712

4Q2012EXCEL DMF# 23420 23421 A 23422 23423 23424 A 23425 A 23426 23427 23428 23429 23430 A 23431 23432 23433 23434 A 23435 A 23436 A 23437 23438 A 23439 A 23440 23441 23442 23443 23444 23445 A 23446 A 23447 A 23448 A 23449 23450 A A II II 1/11/2010 1/7/2010 MACLEODS PHARMACEUTICALS LTD LAURUS LABS PRIVATE LTD II 5/26/2010 JUBILANT LIFE SCIENCES LTD III 1/12/2010 TRIMAR INTERNATIONAL CORP II 1/8/2010 ALP PHARM BEIJING CO LTD A A A A A II II II II II III 1/8/2010 1/12/2010 1/8/2010 1/11/2010 1/7/2010 1/11/2010 SCI PHARMTECH INC MYLAN LABORATORIES LTD MSN PHARMACHEM PVT LTD EMCURE PHARMACEUTICALS LTD PROVENTUS LIFE SCIENCES PVT LTD TEIJIN FIBERS LTD II 1/7/2010 CADILA HEALTHCARE LTD C II II 1/4/2010 12/31/2009 CERBIOS PHARMA SA NECTAR LIFESCIENCES LTD II 12/31/2009 II 1/6/2010 A A A II II II II 1/6/2010 1/6/2010 1/6/2010 1/6/2010 MYLAN LABORATORIES LTD CADILA HEALTHCARE LTD CADILA HEALTHCARE LTD CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD AUROBINDO PHARMA LTD A A A P III 7/21/2009 II II II 12/31/2009 1/5/2010 1/5/2010 II 12/29/2009 A A II II II 12/29/2009 12/28/2009 12/28/2009 MACLEODS PHARMACEUTICALS LTD SCINOPHARM TAIWAN LTD ALP PHARM BEIJING CO LTD STATUS Type SUBMIT DATE A IV II 12/18/2009 12/30/2009 HOLDER DOW CORNING CORP WUHAN WUYAO PHARMACEUTICAL CO LTD SUBJECT

4Q2012

DOW CORNING Q7-9180 SILICONE FLUIDS AS MANUFACTURED IN HEMLOCK MI METRONIDAZOLE AS MANUFACTURED IN WUHAN CHINA VALACICLOVIR HYDROCHLORIDE DIHYDRATE AS MANUFACTURED IN GUJARAT INDIA TRAVOPROST AS MANUFACTURED IN TAINAN COUNTY TAIWAN ROC

ESZOPICLONE AS MANUFACTURED IN ZHEJIANG CHINA FOR ALP PHARM BEIJING CO LTD SOUTHWEST SYNTHETIC PHARMACEUTICAL SIMVASTATIN NON STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN CO LTD CHONGQING PR CHINA ALEMBIC PHARMACEUTICALS LTD DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA INDUSTRIALE CHIMICA SRL INDUSTRIALE CHIMICA SRL *** PENDING FILING REVIEW *** ASTRA PLASTIQUE CLOSURE: REFERENCE 1442 AS MANUFACTURED IN SAINT-GEORGES DE RENEINS FRANCE LAMIVUDINE USP (LVD) AS MANUFACTURED IN ANDHRA PRADESH INDIA RANOLAZINE AS MANUFACTURED IN GUJARAT INDIA GEMCITABINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA METAXALONE AS MANUFACTURED IN TAIPEI HSIEN TAIWAN MYCOPHENOLATE SODIUM AS MANUFACTURED IN TAIPEI HSIEN TAIWAN CLINDAMYCIN PALMITATE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA CALCIUM LEVOFOLINATE AS MANUFACTURED IN BARBENGO/LUGANO SWITZERLAND 7-AMINO-3-VINYL-3-CEPHEM-4-CARBOXYLIC ACID (7-AVCA) [NON-STERILE DRUG SUBSTANCE INTERMEDIATE] AS MANUFACTURED IN CHANDIGARH INDIA CLOPIDOGREL BISULFATE USP (FORM-I) (CUE ROUTE) AS MANUFACTURED IN GUJARAT INDIA DULOXETINE HYDROCHLORIDE (DULO.HCI) AS MANUFACTURED IN TAOYUAN TAIWAN VARENICLINE TARTRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA SUMATRIPTAN USP [ROUTE CODE SN] AS MANUFACTURED IN ANDHRA PRADESH INDIA TOPOTECAN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA PRIMIDONE AS MANUFACTURED IN CHENNAI INDIA POLYETHYLENE TEREPHTHALATE RESIN (TYPE SD-M) AS MANUFACTURED IN EHIME PREF JAPAN CIDOFOVIR DIHYDRATE AS MANUFACTURED IN SHANDONG CHINA PC FOR ALP PHARM BEIJING CO LTD HIGH DENSITY POLYETHYLENE (HDPE) BOTTLES AS MANUFACTURED IN YUNLIN COUNTY TAIWAN ESOMEPRAZOLE MAGNESIUM (AMORPHOUS) (ESUB) AS MANUFACTURED IN KARNATAKA INDIA IRBESARTAN AS MANUFACTURED IN GUJARAT INDIA TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN ANDHRA PRADESH INDIA FLUTICASONE PROPIONATE AS MANUFACTURED IN SARONNO (VARESE) ITALY DIENOGEST AS MANUFACTURED IN SARONNO (VARESE) ITALY

Page 713

4Q2012EXCEL DMF# 23451 23452 A 23453 23454 23455 23456 A 23457 23458 A 23459 A 23460 23461 23462 23463 A 23464 A 23465 A 23466 23467 A 23468 23469 A 23470 23471 23472 23473 23474 23475 23476 23477 23478 23479 23480 23481 23482 23483 A A A A A A I A A A A A A A III III II II II II II II II II II IV II III 1/18/2010 1/18/2010 1/21/2010 1/21/2010 1/18/2010 1/21/2010 2/20/2010 1/18/2010 1/22/2010 1/22/2010 1/26/2010 1/20/2010 1/26/2010 12/26/2009 GREEN PACK FOILS PRIVATE LTD GREEN PACK FOILS PRIVATE LTD DR REDDYS LABORATORIES LTD GLOCHEM INDUSTRIES LTD PARABOLIC DRUGS LTD SEQUENT SCIENTIFIC LTD UNIMARK REMEDIES LTD CAMBREX PROFARMACO MILANO SRL CYALUME SPECIALTY PRODUCTS INC SHILPA MEDICARE LTD INDUSTRIALE CHIMICA SRL UNGERER AND CO CYALUME SPECIALTY PRODUCTS INC PACKNOWCRAT INDIA PVT LTD A III II 1/8/2010 1/12/2010 HB FULLER CO CHANGZHOU AHK TECH INC PHC9255 AS MANUFACTURED IN MESQUITE TX A II II 1/20/2010 1/15/2010 MSN LABORATORIES LTD WANBURY LTD V 1/20/2010 II 1/14/2010 LABORATORIO CHIMICO INTERNAZIONALE SPA LONZA HOUSTON INC A A A II II III III 1/18/2010 1/15/2010 1/15/2010 1/15/2010 DR REDDYS LABORATORIES LTD CYALUME SPECIALTY PRODUCTS INC DA PRO RUBBER INC MINNESOTA RUBBER AND PLASTICS II 1/15/2010 EMCURE PHARMACEUTICALS LTD N II 1/8/2010 A A A II III II II 1/11/2010 1/14/2010 1/14/2010 8/3/2010 PARABOLIC DRUGS LTD KANEKA BELGIUM NV AMINO CHEMICALS LTD SHANGHAI ZIYUAN PHARMACEUTICAL CO LTD NOT AN ASSIGNED NUMBER QILU PHARMACEUTICAL CO LTD STATUS Type SUBMIT DATE A II V 1/11/2010 1/11/2010 HOLDER HUANGSHI MEIFENG CHEMICAL CO LTD OFFICE SURGEON GENERAL DEPT ARMY SUBJECT SULISOBENZONE AS MANUFACTURED IN HUBEI PR CHINA

4Q2012

SKIN EXPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTS (SERPACWA) LOCATED IN FORT DETRICK MARYLAND CEFUROXIME AXETIL (CRYSTALLINE) PROCESS-II AS MANUFACTURED IN PUNJAB INDIA KANE ACE B-28A AS MANUFACTURED IN WESTERLO-OEVEL BELGIUM BOSENTAN MONOHYDRATE AS MANUFACTURED IN MARSA MALTA NAFTIFINE HYDROCHLORIDE NON-STERILE BULK DRUG (ESUB) AS MANUFACTURED IN SHANGHAI CHINA DOCETAXEL AS MANUFACTURED IN JINAN SHANDONG PROVINCE PEOPLES REPUBLIC OF CHINA SEVELAMER CARBONATE (FOR POWDER FORMULATION) (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA RASAGILINE MESYLATE AS MANUFACTURED IN ANDHRA PRADESH INDIA CHLORPHENIRAMINE TANNATE AS MANUFACTURED IN BOUND BROOK NJ PACKAGING MATERIAL AS MANUFACTURED IN BROKEN ARROW OK A RUBBER FLUOROELASTOMER FOR SEALING APPLICATIONS IN MEDICAL DEVICES AS MANUFACTURED BY MINNESOTA RUBBER AND PLASTICS IN TAMAULIPAS MEXICO FENOFIBRIC ACID CHOLINE SALT AS MANUFACTURED IN SEGRATE MI ITALY CLINICAL PHASE BIOLOGICS SPECIALIZING IN ADENOVIRAL BASED GENE THERAPY PRODUCTS LOCATED IN HOUSTON TX EPLERENONE [ROUTE CODE: PL] AS MANUFACTURED IN ANDHRA PRADESH INDIA CARVEDILOL PHOSPHATE MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA INDIA

CYTARABINE USP NON-STERILE BULK DRUG AS MANUFACTURED IN JIANGSU PROVINCE PR CHINA ALUMINIUM STRIP FOIL (LAMINATED/PRINTED) AS MANUFACTURED IN GUJARAT INDIA ALUMINIUM BLISTER FOIL (COATED/PRINTED) AS MANUFACTURED IN GUJARAT INDIA TELMISARTAN (PROCESS-II) AS MANUFACTURED IN ANDHRA PRADESH INDIA CLOPIDOGREL BISULPHATE FORM-I AS MANUFACTURED IN ANDHRA PRADESH INDIA CEFIXIME AS MANUFACTURED IN PUNJAB INDIA TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN KARNATAKA INDIA ESZOPICLONE (ESUB) AS MANUFACTURED IN GUJARAT INDIA SODIUM PICOSULFATE AS MANUFACTURED IN MILAN ITALY DEXTROMETHORPHAN TANNATE AS MANUFACTURED IN BOUND BROOK NJ TEMOZOLOMIDE AS MANUFACTURED IN KARNATAKA INIDA BIMATOPROST AS MANUFACTURED IN SARONNO (VARESE) ITALY ARTIFICIAL TUTTI FRUITTI FLAVOR FS-6943 AS MANUFACTURED IN BETHLEHEM PA PSEUDOEPHEDRINE TANNATE AS MANUFACTURED IN BOUND BROOK NJ FLEXIBLE PACKAGING MATERIAL AS MANUFACTURED IN MAHARASHTRA INDIA

Page 714

4Q2012EXCEL DMF# 23484 A 23485 A 23486 A 23487 A 23488 A 23489 23490 23491 A 23492 23493 23494 A 23495 23496 A 23497 23498 23499 A 23500 23501 23502 A 23503 A 23504 A 23505 23506 A 23507 23508 A 23509 23510 23511 23512 A A A A II II II II 2/2/2010 4/21/2010 1/22/2010 1/22/2010 RAKS PHARMA PVT LTD BASF PHARMA CALLANISH LTD SUPRIYA LIFESCIENCE LTD SUPRIYA LIFESCIENCE LTD A II II 1/27/2010 1/16/2010 AREVIPHARMA GMBH QILU PHARMACEUTICAL CO LTD A III II 1/26/2010 2/2/2010 II 2/1/2010 II 1/22/2010 A A II II II 2/16/2010 2/16/2010 5/6/2010 UNIMARK REMEDIES LTD UNIMARK REMEDIES LTD TARO PHARMACEUTICAL INDUSTRIES LTD A A III III III 1/22/2010 1/22/2010 2/1/2010 LG CHEM LTD LG CHEM LTD KLOCKNER PENTAPLAST A II II 1/29/2010 1/29/2010 APOTEX PHARMACHEM INC SANOFI CHIMIE MONTELUKAST SODIUM AS MANUFACTURED IN ONTARIO CANADA A A III II II 1/20/2010 1/22/2010 4/30/2010 A A III II II 1/21/2010 1/28/2010 1/22/2010 HYUNDAI ENGINEERING PLASTICS CO LTD APOTEX PHARMACHEM INC ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD PRETIUM PACKAGING HUBEI HAOSUN PHARMACEUTICAL CO LTD PHF SA II 1/27/2010 MSN LABORATORIES LTD II 1/27/2010 HAINAN POLY PHARMACEUTICAL CO LTD II 1/27/2010 HAINAN POLY PHARMACEUTICAL CO LTD II 2/7/2010 BGP HEALTHCARE PRIVATE LTD NICOTINE USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA STATUS Type SUBMIT DATE II 5/7/2010 HOLDER NEKTAR THERAPEUTICS SUBJECT

4Q2012

N-HYDROXYSUCCINIMIDYL ESTER OF BIS (METHOXYPOLY(ETHYLENE GLYCOL) MW 20,000) MODIFIED LYSINE (ESUB) AS MANUFACTURED IN HUNTSVILLE AL

AZITHROMYCIN GRANULES FOR ORAL SUSPENSION AS MANUFACTURED IN HAINAN PROVINCE CHINA GLUCOSAMINE HYDROCHLORIDE PELLETS CAPSULES AS MANUFACTURED IN HAINAN PROVINCE CHINA PITAVASTATIN CALCIUM [ROUTE CODE: PC] AS MANUFACTURED IN ANDHRA PRADESH INDIA PACKAGING MATERIAL AS MANUFACTURED IN CHUNGNAM KOREA LUBIPROSTONE AS MANUFACTURED IN ONTARIO CANADA VALSARTAN USP (PROCESS II) AS MANUFACTURED IN ZHEJIANG CHINA PLASTIC PACKAGING MATERIAL AS MANUFACTURED IN PHILMONT NY AMISULPRIDE AS MANUFACTURED IN HUBEI PR CHINA DUTASTERIDE (ESUB) AS MANUFACTURED IN MARCON VENEZIA ITALY FOR PHF SA

CABAZITAXEL ACETONE SOLVATE AS MANUFACTURED IN VITRY-SUR-SEINE FRANCE FOR SANOFI CHIMIE PP PRODUCTS AS MANUFACTURED IN SEOUL KOREA LDPE PRODUCTS AS MANUFACTURED IN SEOUL KOREA POLYESTER BASED PACKAGING FILMS AS MANUFACTURED IN GORDONSVILLE VIRGINIA; MONTABAUR, GERMANY AND LIEBEFELD/BERN SWITZERLAND NITROFURANTOIN ANHYDROUS USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA NITROFURANTOIN MONOHYDRATE USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA

MOMETASONE FUROATE USP/PH EUR MICRONIZED (ESUB) AS MANUFACTURED IN HAIFA BAY ISRAEL CALYX CHEMICALS AND PHARMACEUTICALS FLUCYTOSINE AS MANUFACTURED IN MAHARASHTRA INDIA LTD BASF SE SOLUPLUS AS MANUFACTURED IN LUDWIGHAFEN, GERMANY AND DRESDEN, GERMANY FOR BASF SE KISHORE PHARMA PRODUCTS PVT LTD TYPE I GLASS AMPOULES AND VIALS AS MANUFACTURED IN KARNATAKA INDIA TEVA PHARMACEUTICAL INDUSTRIES LTD PACLITAXEL SEMISYNTHETIC AS MANUFACTURED IN OPAVA KOMAROV CZECH REPUBLIC FLUTAMIDE AS MANUFACTURED IN RADEBEUL, GERMANY EXEMESTANE (NON STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE PR CHINA SILDENAFIL CITRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA OMEGA-3 ACID ETHYL ESTERS 78 (ESUB) AS MANUFACTURED IN SCOTLAND UK BROMPHENIRAMINE MALEATE AS MANUFACTURED IN MAHARASHTRA INDIA PHENIRAMINE MALEATE AS MANUFACTURED IN MAHARASHTRA INDIA

Page 715

4Q2012EXCEL DMF# 23513 23514 23515 A 23516 23517 23518 A 23519 23520 A 23521 23522 23523 23524 A 23525 A 23526 A 23527 23528 23529 23530 A 23531 A 23532 23533 C 23534 23535 A 23536 A 23537 23538 23539 23540 A 23541 23542 23543 23544 A A A A II II II II 4/7/2010 3/31/2010 4/8/2010 4/15/2010 LUPIN LTD LUPIN LTD LUPIN LTD LUPIN LTD A A C II III II II 2/4/2010 1/13/2010 2/13/2010 2/19/2010 SCI PHARMTECH INC PRADEEP LAMINATORS PVT LTD LAURUS LABS PRIVATE LTD TEVA PHARMACEUTICAL INDUSTRIES LTD II 1/30/2010 ALP PHARM BEIJING CO LTD A III II 2/3/2010 1/31/2010 APTAR RADOLFZELL GMBH ALP PHARM BEIJING CO LTD A II II 1/29/2010 2/16/2010 FERMION OY MSN LABORATORIES LTD V 2/4/2010 BASF SE A A A III II IV II 1/14/2010 2/11/2010 2/15/2010 2/8/2010 III 1/27/2010 CCC PLASTICS CANADA COLORS AND CHEMICALS LTD KEJARIWAL INDUSTRIES JSC OLAINFARM EMERSON RESOURCES INC QILU PHARMACEUTICAL CO LTD II 2/3/2010 A A A II II II II 2/5/2010 1/10/2010 2/12/2010 2/11/2010 C II II 2/8/2010 2/4/2010 BIOCON LTD SIEGFRIED USA LLC MYCOPHENOLATE SODIUM AS MANUFACTURED IN BANGALORE INDIA A A II IV IV 2/12/2010 2/8/2010 2/9/2010 EUTICALS SPA FONA INTERNATIONAL INC FONA INTERNATIONAL INC STATUS Type SUBMIT DATE A A II III III 2/18/2010 2/2/2010 1/29/2010 HOLDER USV LIMITED IFS INDUSTRIES INC BASELL POLYOLEFINE ITALIA SRL SUBJECT

4Q2012

ATOVAQUONE USP (FORM III) (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA IFS HOT MELT #M-766-2V (HM-560) AS MANUFACTURED IN READING PA PURELL PE 3420 F AS MANUFACTURED IN WESSELING, GERMANY FOR BASELL POLYOLEFINE ITALIA SRL GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN VARESE ITALY PRODUCT # 825.744 CHERRY FLAVOR ARTIFICIAL AS MANUFACTURED IN GENEVA IL PRODUCT # 877.0131U N-C MINT FLAVOR NAT WONF AS MANUFACTURED IN GENEVA IL

OXYCODONE HYDROCHLORIDE USP (LOW ABUK IMPURITY) AS MANUFACTURED IN PENNSVILLE NJ DERIVADOS QUIMICOS SA FINE CHEMICALS CYCLOBENZAPRINE HYDROCHLORIDE AS MANUFACTURED IN MURCIA SPAIN HUBEI HAOSUN PHARMACEUTICAL CO LTD NATCO PHARMA LTD SHENZHEN HAIBIN PHARMACEUTICAL CO LTD AUROBINDO PHARMA LTD IRINOTECAN HYDROCHLORIDE AS MANUFACTURED IN HUBEI PR CHINA LANSOPRAZOLE AS MANUFACTURED IN ANDHRA PRADESH INDIA MEROPENEM STERILE AS MANUFACTURED IN GUANGDONG PROVINCE, PR CHINA OLANZAPINE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA WHITE MB50-9576 POLYPROPYLENE COLOUR CONCENTRATE AS MANUFACTURED IN ONTARIO CANADA GLASS AMPOULES AND VIALS AS MANUFACTURED IN DELHI INDIA AMANTADINE HYDROCHLORIDE AS MANUFACTURED IN OLAINE LATVIA PLASACRYL PF AS MANUFACTURED IN NORRISTOWN PA OXALIPLATIN (NON-STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE PEOPLES REPUBLIC OF CHINA SOLUTOL HS 15 PRE-CLINICAL SAFETY DATA AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY METHOTREXATE DISODIUM AS MANUFACTURED IN OULU FINLAND DUTASTERIDE [ROUTE CODE - DT] [NON-STERILE DRUG SUBSTANCE] AS MANUFACTURED IN ANDHRA PRADESH INDIA POWDER DISPENSING DEVICES AS MANUFACTURED IN EIGELTINGEN, GERMANY URSODEOXYCHOLIC ACID (DRUG SUBSTANCE NON-STERILE) AS MANUFACTURED IN SUZHOU JIANGSU CHINA FOR ALP PHARM BEIJING CO LTD ADAPALENE (DRUG SUBTANCE NON-STERILE) AS MANUFACTURED IN SHANDONG CHINA FOR ALP PHARM BEIJING CO LTD PROPAFENONE HYDROCHLORIDE AS MANUFACTURED IN TAOYUAN TAIWAN RETORT POUCHES AS MANUFACTURED IN MAHARASHTRA INDIA LATANOPROST AS MANUFACTURED IN ANDHRA PRADESH INDIA FENOFIBRATE CHOLINE AS MANUFACTURED IN ZAGREB CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD EZETIMIBE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA RITONAVIR USP (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA CELECOXIB (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA CEFDITOREN PIVOXIL (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA

Page 716

4Q2012EXCEL DMF# 23545 23546 23547 A 23548 23549 A 23550 A 23551 A 23552 23553 23554 23555 23556 23557 A 23558 A 23559 23560 23561 23562 C 23563 23564 23565 A 23566 A 23567 23568 23569 23570 A 23571 A 23572 23573 A 23574 A III 3/1/2010 SABIC PETROCHEMICALS BV A II III 2/23/2010 3/1/2010 PARABOLIC DRUGS LTD SABIC PETROCHEMICALS BV IV 3/16/2010 DOTTIKON EXCLUSIVE SYNTHESIS AG A A A II III II II 2/22/2010 2/22/2010 2/24/2010 3/12/2010 HIKAL LTD LABLABO DR REDDYS LABORATORIES LTD UNIMARK REMEDIES LTD MEMANTINE HYDROCHLORIDE API AS MANUFACTURED IN BANGALORE INDIA METERED AEROSOL VALVES AS MANUFACTURED IN ANNEMASSE FRANCE RILUZOLE AS MANUFACTURED IN ANDHRA PRADESH INDIA II 3/3/2010 ARCH PHARMALABS LTD A A II II III 2/23/2010 2/23/2010 2/18/2010 SHILPA MEDICARE LTD DR REDDYS LABORATORIES LTD AMPACET CORP OXALIPLATIN AS MANUFACTURED IN KARNATAKA INDIA AZACITIDINE AS MANUFACTURED IN ANDHRA PRADESH INDIA A A A II II II II 2/12/2010 2/19/2010 2/22/2010 2/23/2010 ARKEMA INC HUBEI MEIKAI CHEMICAL CO LTD SEQUENT SCIENTIFIC LTD SHILPA MEDICARE LTD II 2/19/2010 A A A P A II II 3/9/2010 2/16/2010 II II II 4/8/2010 3/8/2010 2/21/2010 LUPIN LTD SUN PHARMACEUTICAL INDUSTRIES LTD CHEMAGIS LTD *** PENDING FILING REVIEW *** USV LIMITED SPECIALTY ENZYMES AND BIOCHEMICALS CO FUJIAN SOUTH PHARMACEUTICAL CO LTD III 11/8/2009 REGO PACKING INDUSTRY CO LTD III 2/19/2010 EI DUPONT DE NEMOURS INC A III III 2/19/2010 2/17/2010 OKADA SHIGYO CO LTD AMPACET CORP STATUS Type SUBMIT DATE A P II 2/17/2010 II 3/16/2010 HOLDER USV LIMITED *** PENDING FILING REVIEW *** CHEMWERTH INC SUBJECT BEXAROTENE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA

4Q2012

TEMOZOLOMIDE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN SICHUAN CHINA FOR CHEMWERTH INC HI-GAL FILM ~ SEIBOU PE-01 AS MANUFACTURED IN OSAKA JAPAN 182136 BEIGE PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA AND HEATH OH DUPONT ELVALOY AC RESINS AS MANUFACTURED IN ZWIJNDRECHT BELGIUM FOR E.I. DUPONT DE NEMOURS INC COLLAPSIBLE LAMINATED TUBES FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN GUANGDON CHINA GATIFLOXACIN (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA TEMOZOLOMIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA CISATRACURIUM BESYLATE AS MANUFACTURED IN BEER SHEVA ISRAEL ATOVAQUONE USP (FORM I) (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA SERRATIOPEPTIDASE AS MANUFACTURED IN NASHIK INDIA FOR SPECIALTY ENZYMES & BIOCHEMICALS CO PACLITAXEL (NATURAL) USP (NATURAL, NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN FUJIAN PR CHINA LUPEROX A75FP AS MANUFACTURED IN PIFFARD NY OXYBENZONE AS MANUFACTURED IN HUBEI CHINA LUMEFANTRINE AS MANUFACTURED IN KARNATAKA INDIA IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN KARNATAKA INDIA

15571 PINK AS PE MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERVILLE GA AND HEATH OH CITALOPRAM HYDROBROMIDE USP (CYANO ROUTE) (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA

NITROFURANTOIN ANHYDROUS CRYSTALS USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA DOTTISOL (ISOSORBIDE DIMETHYL ETHER) (ESUB) AS MANUFACTURED IN DOTTIKON SWITZERLAND CEFPODOXIME PROXETIL AS MANUFACTURED IN PUNJAB INDIA SABIC LDPE PCG00 AS MANUFACTURED IN AI GELEEN THE NETHERLANDS FOR SABIC PETROCHEMICALS BV SABIC LDPE PCG01 AS MANUFACTURED IN AI GELEEN THE NETHERLANDS FOR SABIC PETROCHEMICALS BV

Page 717

4Q2012EXCEL DMF# 23575 A 23576 A 23577 A 23578 23579 A 23580 23581 23582 A 23583 A 23584 23585 23586 23587 23588 23589 23590 23591 23592 23593 A 23594 A 23595 23596 23597 A 23598 A 23599 A 23600 23601 C 23602 23603 A 23604 23605 A I II II 4/29/2010 2/22/2010 MALLINCKRODT INC AANJANEYA LIFECARE LTD A IV II 3/1/2010 3/22/2010 A II II 3/3/2010 2/26/2010 SANOFI AVENTIS SPA AUROBINDO PHARMA LTD II 3/2/2010 II 2/23/2010 A A II II II 3/1/2010 3/3/2010 2/23/2010 FERMION OY DR REDDYS LABORATORIES LTD ZHEJIANG SUPOR PHARMACEUTICALS CO LTD ZHEJIANG SUPOR PHARMACEUTICALS CO LTD MSN LABORATORIES LTD II 2/25/2010 CQ INTERNATIONAL CO INC A A A A A A A A A II II III III II II II II II II 2/24/2010 3/2/2010 2/18/2010 2/26/2010 2/25/2010 7/30/2010 3/1/2010 3/1/2010 2/26/2010 3/12/2010 II 3/4/2010 A A II II II 8/16/2010 5/28/2010 3/25/2010 SUN PHARMACEUTICAL INDUSTRIES LTD SUN PHARMACEUTICAL INDUSTRIES LTD ALKALOIDA CHEMICAL CO ZRT A II III 2/24/2010 2/5/2010 III 3/1/2010 III 3/1/2010 STATUS Type SUBMIT DATE III 3/1/2010 HOLDER SABIC PETROCHEMICALS BV SUBJECT

4Q2012

SABIC LDPE PCG02 AS MANUFACTURED IN AI GELEEN THE NETHERLANDS FOR SABIC PETROCHEMICALS BV SABIC PETROCHEMICALS BV SABIC LDPE PCG07 AS MANUFACTURED IN AI GELEEN THE NETHERLANDS FOR SABIC PETROCHEMICALS BV SABIC PETROCHEMICALS BV SABIC LDPE PCG09 AS MANUFACTURED IN AI GELEEN THE NETHERLANDS FOR SABIC PETROCHEMICALS BV DERIVADOS QUIMICOS SA FINE CHEMICALS LANSOPRAZOLE AS MANUFACTURED IN MURCIA SPAIN AMCOR FLEXIBLES BURGDORF GMBH LAMINATE POLYESTER 23 / ALUMINIUM 12 / LDPE 50 (SOP 51284) AS MANUFACTURED IN BURGDORF SWITZERLAND DROSPIRENONE USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA RIZATRIPTAN BENZOATE (ESUB) AS MANUFACTURED IN GUJARAT INDIA

HYDROXYCHLOROQUINE SULFATE USP (ESUB) AS MANUFACTURED IN TISZAVASVARI HUNGARY JOHNSON MATTHEY INC PHARMACEUTICAL DEXTROAMPHETAMINE SULFATE USP (PROCESS 2) AS MANUFACTURED IN WEST MATERIALS GROUP DEPTFORD NJ ALEMBIC PHARMACEUTICALS LTD VALSARTAN USP (PROCESS II) AS MANUFACTURED IN GUJARAT INDIA AMOLI ORGANICS PVT LTD ESSEL PROPACK LTD BERRY PLASTICS CORP HAMARI CHEMICALS LTD IPCA LABORATORIES LTD DR REDDYS LABORATORIES LTD DR REDDYS LABORATORIES LTD EGIS PHARMACEUTICALS PLC UNIMARK REMEDIES LTD LEVETIRACETAM AS MANUFACTURED IN GUJARAT INDIA LAMINATED TUBES AS MANUFACTURED IN THE NALAGARH DIST SOLAN HP INDIA MARVELLINER 8CB1CP-PET AS MANUFACTURED IN COLUMBUS GA GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN OSAKA JAPAN AMLODIPINE BESYLATE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH INDIA RITONAVIR USP AS MANUFACTURED IN ANDHRA PRADESH INDIA ROSUVASTATIN AS MANUFACTURED IN BUDAPEST HUNGARY HYDROXYCHLOROQUINE SULFATE USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA VANCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA FOR CQ INTERNATIONAL CO INC TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN OULU FINLAND DECITABINE AS MANUFACTURED IN ANDHRA PRADESH INDIA OLANZAPINE AS MANUFACTURED IN ZHEJIANG PR CHINA RIZATRIPTAN BENZOATE AS MANUFACTURED IN ZHEJIANG PR CHINA TERTIARY BUTYL AMINE SALT OF ROSUVASTATIN [ROUTE CODE - ROC1] AS MANUFACTURED IN ANDHRA PRADESH KETOPROFEN AS MANUFACTURED IN FRANKFURT AM MAIN, GERMANY

LAMIVUDINE USP (CRYSTALLINE POLYMORPH FORM I) AS MANUFACTURED IN ANDHRA PRADESH INDIA HENRY H OTTENS MANUFACTURING CO INC ARTIFICIAL BUBBLE GUM FLAVOR #3266-Q AS MANUFACTURED IN PHILADELPHIA PA TORRENT PHARMACEUTICALS LTD ALFUZOSIN HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA NALBUPHINE HYDROCHLORIDE (1P) (ESUB) AS MANUFACTURED IN ST LOUIS MO QUININE HYDROCHLORIDE EP DRUG SUBSTANCE AS MANUFACTURED IN MAHAD INDIA

Page 718

4Q2012EXCEL DMF# 23606 I 23607 A 23608 A 23609 A 23610 A 23611 A 23612 23613 23614 A 23615 23616 A 23617 23618 C 23619 A 23620 23621 23622 23623 A 23624 A 23625 23626 A 23627 23628 23629 A 23630 A 23631 23632 23633 A A A II II II 4/26/2010 5/21/2010 3/31/2010 APICORE LLC ARCH PHARMALABS LTD ARCH PHARMALABS LTD BEXAROTENE (ESUB) AS MANUFACTURED IN SOMERSET NJ II 3/11/2010 A A II II II 3/29/2010 5/26/2010 3/31/2010 JUBILANT LIFE SCIENCES LTD JUBILANT LIFE SCIENCES LTD A II V 3/16/2010 2/23/2010 HARMAN FINOCHEM LTD BASF SE II 3/10/2010 DIVIS LABORATORIES LTD A A A II II II II 3/11/2010 3/10/2010 3/2/2010 3/2/2010 MACLEODS PHARMACEUTICALS LTD DR REDDYS LABORATORIES LTD GOLDEN SHELL BIOCHEMICAL CO LTD GOLDEN SHELL BIOCHEMICAL CO LTD QUETIAPINE FUMARATE AS MANUFACTURED IN GUJARAT INDIA RANOLAZINE AS MANUFACTURED IN ANDHRA PRADESH INDIA GLUCOSAMINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA II 4/12/2010 LUPIN LTD I II II 3/20/2010 4/8/2010 UNIMARK REMEDIES LTD LUPIN LTD A II II 3/9/2010 3/8/2010 A A II IV II 3/30/2011 3/8/2010 3/11/2010 LUPIN LTD LIPIDCHEM SENDIRIAN SHANDONG RUIYING PIONEER PHARMACEUTICAL CO LTD MERCK KGAA CKD BIO CORP NORGESTREL USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA STEARIC ACID AS MANUFACTURED IN JOHOR MALAYSIA PIPERACILLIN AS MANUFACTURED IN SHANDONG PROVINCE PR CHINA POTASSIUM IODIDE AS MANUFACTURED IN FRANKFURTER STR., GERMANY II 4/12/2010 LUPIN LTD IV 3/10/2010 FONA INTERNATIONAL INC IV 3/9/2010 FONA INTERNATIONAL INC IV 3/9/2010 FONA INTERNATIONAL INC III 2/23/2010 RAUMEDIC AG STATUS Type SUBMIT DATE II 2/22/2010 HOLDER QILU PHARMACEUTICAL CO LTD SUBJECT

4Q2012

CARBOPLATIN (NON-STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE PEOPLES REPUBLIC OF CHINA RAUMEDIC PVC-FREE COEXTRUDED FILLING TUBES (RAUMED TUBING RFT) AS MANUFACTURED IN HELMBRECHTS, GERMANY PRODUCT # 825.666 N-C CHERRY FLAVOR NAT WONF AS MANUFACTURED IN GENEVA IL PRODUCT # 805.0100U N-C BANANA FLAVOR NAT & ART AS MANUFACTURED IN GENEVA IL PRODUCT # 802.0003U ANISE LIQUER TYPE FLAVOR NAT AS MANUFACTURED IN GENEVA IL ATAZANAVIR SULFATE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA

RIFAMYCIN SODIUM NON-STERILE BULK AS MANUFACTURED IN ANSAN KYUNGGI-DO SOUTH KOREA OLMESARTAN MEDOXOMIL (ESUB) AS MANUFACTURED IN GUJARAT INDIA ABACAVIR SULFATE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA DESOGESTREL (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA FOR LUPIN LTD

GLUCOSAMINE SULFATE POTASSIUM CHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA SUMATRIPTAN SUCCINATE AND SUMATRIPTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA OXICONAZOLE NITRATE AS MANUFACTURED IN MAHARASHTRA INDIA SOLUPLUS PRE-CLINICAL SAFETY DATA AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY ZOLMITRIPTAN (ESUB) AS MANUFACTURED IN KARNATAKA INDIA ESOMEPRAZOLE SODIUM (ESUB) AS MANUFACTURED IN KARNATAKA INDIA

ORCHID CHEMICALS AND TOLTERODINE TARTRATE (NON-STERILE BULK API) (ESUB) AS MANUFACTURED IN PHARMACEUTICALS LTD MAHARASHTRA INDIA CENTAUR PHARMACEUTICALS PRIVATE LTD TIMOLOL MALEATE USP AS MANUFACTURED IN MAHARASHTRA INDIA

AMLODIPINE BESYLATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA GEMCITABINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA

Page 719

4Q2012EXCEL DMF# 23634 A 23635 A 23636 A 23637 23638 C 23639 A 23640 23641 A 23642 A 23643 A 23644 A 23645 A 23646 A 23647 A 23648 I 23649 A 23650 23651 23652 23653 A 23654 23655 A 23656 23657 A 23658 A 23659 A II 3/30/2010 CHONGQING HUAPONT PHARMACEUTICAL CO LTD II 3/27/2010 DR REDDYS LABORATORIES LTD A II II 3/23/2010 4/8/2010 DR REDDYS LABORATORIES LTD AUROBINDO PHARMA LTD BIVALIRUDIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA A IV II 3/18/2010 3/22/2010 NUSIL TECHNOLOGY LLC DR REDDYS LABORATORIES LTD A A A II II II II 3/23/2010 3/25/2010 3/24/2010 3/15/2010 II 3/18/2010 JIANGXI SYNERGY PHARMACEUTICAL CO LTD AARTI INDUSTRIES LTD APOTEX PHARMACHEM INDIA PVT LTD INDUSTRIALE CHIMICA SRL YONSUNG FINE CHEMICALS CO LTD III 3/23/2010 MITSUI CHEMICALS AMERICA INC III 3/16/2010 AMPACET CORP III 3/16/2010 AMPACET CORP II 3/15/2010 AVANTI POLAR LIPIDS INC II 3/19/2010 SIGNA SA DE CV II 3/12/2010 ALP PHARM BEIJING CO LTD II 3/12/2010 ALP PHARM BEIJING CO LTD A II II 3/17/2010 3/12/2010 II 3/30/2010 ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORGAPHARM ALP PHARM BEIJING CO LTD A II II 3/17/2010 3/18/2010 II 3/16/2010 ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD RAKS PHARMA PVT LTD HOVIONE FARMACIENCIA SA II 4/16/2010 AURISCO PHARMACEUTICAL LTD STATUS Type SUBMIT DATE II 5/6/2010 HOLDER ANTARIA LTD SUBJECT

4Q2012

ZINCLEAR-IM_50CCT (ESUB) AS MANUFACTURED IN WELSHPOOL WESTERN AUSTRALIA

DIDANOSINE AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA FOR AURISCO PHARMACEUTICAL LIMITED KETOPROFEN AS MANUFACTURED IN ZHEJIANG CHINA SALSALATE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA DOXYCYCLINE MONOHYDRATE MICRONIZED AS MANUFACTURED IN TAIPA MACAU SAR FOR HOVIONE FARMACIENCIA SA LEVOFLOXACIN (NON-STRILE BULK API) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ETHIONAMIDE DRUG SUBSTANCE AS MANUFACTURED IN PITHIVIERS FRANCE ITRACONAZOLE (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN ZHEJIANG CHINA FOR ALP PHARM BEIJING CO LTD NAPHAZOLINE HYDROCHLORIDE (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN TIANJIN CHINA FOR ALP PHARM BEIJING CO LTD NAPHAZOLINE NITRATE (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN TIANJIN CHINA FOR ALP PHARM BEIJING CO LTD ABACAVIR SULFATE AS MANUFACTURED IN TOLUCA MEXICO FOR APOTEX PHARMACHEM INC 1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DOPC) AS MANUFACTURED IN ALABASTER AL 782896 / DARK AMBER PET MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA AND HEATH OH 782895 / LIGHT AMBER PET MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA AND HEATH OH ADMER NF458A AS MANUFACTURED IN SIDNEY OH FOR MITSUI CHEMICALS AMERICA INC CANDESARTAN CILEXETIL AS MANUFACTURED IN JIANGXI PROVINCE PR CHINA CICLESONIDE AS MANUFACTURED IN MAHARASHTRA INDIA ELETRIPTAN HYDROBROMIDE AS MANUFACTURED IN KARNATAKA, INDIA DESOGESTREL CN AS MANUFACTURED IN SARONNO (VARESE), ITALY BROMFENAC SODIUM SESQUIHYDRATE AS MANUFACTURED IN GYEONGGI-DO, REPUBLIC OF KOREA DDR-1370 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN CAPINTERIA, CA DEXLANSOPRAZOLE (CRYSTALLINE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

FLUVASTATIN SODIUM USP (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA OLMESARTAN MEDOXOMIL (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA LEVOCETIRIZINE HCL AS MANUFACTURED IN CHONGQING, CHINA

Page 720

4Q2012EXCEL DMF# 23660 23661 23662 23663 23664 A 23665 A 23666 23667 I 23668 23669 A 23670 A 23671 A 23672 23673 A 23674 I 23675 A 23676 A 23677 A 23678 23679 A 23680 23681 23682 23683 C 23684 A 23685 23686 A A II II 4/6/2010 4/3/2010 SMS PHARMACEUTICALS LTD CSPC WEISHENG PHARMACEUTICAL SHIJIAZHUANG CO LTD II 4/5/2010 JANSSEN PHARMACEUTICA NV A A A II II II II 3/21/2010 3/31/2010 3/29/2010 4/5/2010 AMOLI ORGANICS PVT LTD RHODES TECHNOLOGIES SYNBIAS PHARMA LTD JANSSEN PHARMACEUTICA NV DICLOFENAC DIETHYLAMINE AS MANUFACTURED IN VAPI, GUJARAT, INDIA HYDROCODONE BITARTRATE, USP AS MANUFACTURED IN COVENTRY, RI TOPOTECAN HYDROCHLORIDE AS MANUFACTURED IN DONETSK, UKRAINE A III II 3/8/2010 4/26/2010 IV 3/26/2010 II 4/2/2010 III 3/22/2010 II 3/31/2010 JINGDEZHEN FUXIANG PHARMACEUTICAL CO LTD INGENIA POLYMERS CORP A II II 4/1/2010 4/2/2010 INDUSTRIALE CHIMICA SRL EMCURE PHARMACEUTICALS LTD II 6/4/2010 DR REDDYS LABORATORIES LTD II 3/31/2010 NOF CORP A II III 3/31/2010 3/31/2010 MACLEODS PHARMACEUTICALS LTD PRAVESHA INDUSTRIES PRIVATE LTD A III II 3/25/2010 4/1/2010 POLYONE CORP XIAN LIBANG PHARMACEUTICAL CO LTD III 3/22/2010 INGENIA POLYMERS CORP STATUS Type SUBMIT DATE A A A A II II II II II 3/16/2011 7/6/2010 6/15/2010 5/21/2010 3/30/2010 HOLDER CIPLA LTD CIPLA LTD CIPLA LTD CIPLA LTD DR REDDYS LABORATORIES LTD SUBJECT DARUNAVIR (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA DARUNAVIR HYDRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA

4Q2012

DARUNAVIR ETHANOLATE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA ENTECAVIR MONOHYDRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA ATORVASTATIN CALCIUM TRIHYDRATE (FORM I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA INGENIA POLYMERS 1004 50% WHITE FOR USE IN PACKAGING MATERIALS AS MANUFACTURED IN ONTARIO, CANADA; ALBERTA, CANADA; HOUSTON, TEXAS CC10117176WE AS MANUFACTURED IN BETHLEHEM, PENNSYLVANIA MELPHALAN HYDROCHLORIDE (NON STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN SHAANXI PROVINCE, P. R. OF CHINA PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN VALSAD GUJARAT, INDIA CHILD RESISTANT (CR) AND CONTINUOUS THREAD (CT) CLOSURES AS MANUFACTURED IN ANDHRA PRADESH, INDIA DIMYRISTOYL PHOSPHATIDYLCHOLINE (DMPC) AS MANUFACTURED IN KUMEGUN OKAYAMA, JAPAN FOR NOF CORP AND HYOGO, JAPAN TESTOSTERONE (ESUB) AS MANUFACTURED IN MORELOS MEXICO FOR DR REDDYS LABORATORIES LIMITED LOTEPREDNOL ETABONATE AS MANUFACTURED IN SARONNO (VARESE), ITALY PROTRIPTYLINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA TAZOBACTAM AS MANUFACTURED IN JIANGXI PROVINCE, P.R. OF CHINA INGENIA POLYMERS 1006, 70% WHITE FOR USE IN PACKAGING MATERIALS MANUFACTURED IN BRANTFORD, ONTARIO; ALBERTA, CANADA AND HOUSTON, TEXAS

POLYPEPTIDE LABORATORIES SWEDEN AB DESMOPRESSIN ACETATE DRUG SUBSTANCE AS MANUFACTURED IN LIMHAMN, SWEDEN UNGERER AND CO NATURAL AND ARTIFICIAL STRAWBERRY ANISE FLAVOR FS-5206 AS MANUFACTURED IN BETHLEHEM, PA TECHNIPAQ INC LAMINATES FOR FLEXIBLE PACKAGING AS MANUFACTURED IN CRYSTAL LAKE, IL ALKEM LABORATORIES LTD RASAGILINE MESYLATE (ESUB) AS MANUFACTURED IN GUJARAT INDIA FOR ALKEM LABORATORIES LIMITED

BUPRENORPHINE HYDROCHLORIDE (R036869) DRUG SUBSTANCE AS MANUFACTURED IN GEEL, BELGIUM AND BEERSE, BELGIUM BUPRENORPHINE BASE (R371605) DRUG SUBSTANCE AS MANUFACTURED IN GEEL, BELGIUM; BEERSE, BELGIUM AND MINDEN, GERMANY CAPECITABINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA SODIUM ASCORBATE AS MANUFACTURED IN HEBEI PROVINCE P.R. OF CHINA

Page 721

4Q2012EXCEL DMF# 23687 A 23688 23689 23690 A 23691 23692 23693 23694 23695 A 23696 A 23697 23698 23699 23700 A 23701 23702 23703 23704 23705 23706 A 23707 23708 C 23709 23710 23711 A 23712 23713 23714 A 23715 A 23716 A 23717 A II 4/13/2010 JM HUBER CORP II 4/13/2010 JM HUBER CORP II 4/13/2010 JM HUBER CORP A A V IV IV 5/11/2010 4/9/2010 4/9/2010 CEPHAZONE PHARMA LLC UNGERER AND CO UNGERER AND CO A A III II II 4/9/2010 4/13/2010 4/6/2010 AMPACET CORP SEQUENT SCIENTIFIC LTD NIPPON RIKA CO LTD A II II 5/10/2010 4/12/2010 SUN PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD N A A A A II IV II II IV 4/9/2010 4/6/2010 4/12/2010 4/9/2010 3/22/2010 NOT AN ASSIGNED NUMBER ALEMBIC PHARMACEUTICALS LTD VIKRAM THERMO INDIA LTD EUTICALS SPA MACLEODS PHARMACEUTICALS LTD ACG LUKAPS DOO DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA A A A II IV II III 4/7/2010 4/7/2010 4/7/2010 2/19/2010 NEULAND LABORATORIES LTD NIPPON CARBIDE INDUSTRIES CO INC FRESENIUS KABI ANTI INFECTIVES SRL REXAM DISPENSING SYSTEMS SAS II 3/31/2010 PARABOLIC DRUGS LTD A A A A II IV II II II 4/6/2010 4/6/2010 4/5/2010 4/7/2010 4/7/2010 CYALUME SPECIALTY PRODUCTS INC AMRI RENSSELAER INC CADILA HEALTHCARE LTD MEDICHEM MANUFACTURING MALTA LTD JIANGSU HENGRUI MEDICINE CO LTD A A II II II 4/5/2010 4/5/2010 4/7/2010 STATUS Type SUBMIT DATE II 5/7/2010 HOLDER ORCHID CHEMICALS AND PHARMACEUTICALS LTD CADILA HEALTHCARE LTD CADILA HEALTHCARE LTD MSN LABORATORIES LTD SUBJECT

4Q2012

RASAGILINE MESYLATE (NON STERILE BULK API) (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA ETODOLAC USP AS MANUFACTURED IN GUJARAT, INDIA SOLIFENACIN SUCCINATE AS MANUFACTURED IN GUJARAT, INDIA OLMESARTAN MEDOXOMIL [ROUTE CODE OX] AS MANUFACTURED IN ANDHRA PRADESH, INDIA DICHLORALPHENAZONE USP AS MANUFACTURED IN BOUND BROOK, NJ TYLOXAPOL, USP EXCIPIENT AS MANUFACTURED IN RENSSELAER, NY CANDESARTAN CILEXETIL (FORM-I) AS MANUFACTURED IN GUJARAT, INDIA MED-201593/M AS MANUFACTURED IN HAL FAR, MALTA TAMSULOSIN HYDROCHLORIDE USP, NON-STERILE, BULK SUBSTANCE AS MANUFACTURED IN JIANGSU, CHINA CEFUROXIME AXETIL (AMORPHOUS) PROCESS II USP AS MANUFACTURED IN MOHALI PUNJAB, INDIA VORICONAZOLE AS MANUFACTURED IN ANDHRA PRADESH INDIA NIKASOL TS-620A AS MANUFACTURED IN TOYAMA, JAPAN AMPICILLIN TRIHYDRATE STERILE AS MANUFACTURED IN VILLADOSE (ROVIGO), ITALY PACKAGING MATERIALS, PHARMACEUTICALS VALVES AS MANUFACTURED IN LE TREPORT, FRANCE

METHACRYLIC ACID COPOLYMER, TYPE C, NF AS MANUFACTURED IN GUJARAT, INDIA BROMFENAC AS MANUFACTURED IN LODI, ITALY SILDENAFIL CITRATE AS MANUFACTURED IN GUJARAT, INDIA EXCIPIENT-HARD GELATIN CAPSULES SHELLS AS MANUFACTURED IN LUDBREG, CROATIA RASAGILINE MESYLATE (ESUB) AS MANUFACTURED IN GUJARAT INDIA VARENICLINE TARTRATE (AS HPC SOLID SOLUTION) AS MANUFACTURED IN BEER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LIMITED 140511-K ORANGE 511 AS MANUFACTURED IN RAYONG, THAILAND LABETALOL HYDROCHLORIDE AS MANUFACTURED IN KARNARAKA, INDIA 5-AMINOLEVULINIC ACID HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN TOCHIGI, JAPAN STERILE MANUFACTURING FACILITY (ESUB) LOCATED IN POMONA CA NATURAL CHERRY WONF FLAVOR FQ-10519 AS MANUFACTURED IN BETHLEHEM, PA NATURAL AND ARTIFICIAL CREME DE MENTHE FLAVOR FT-2423 AS MANUFACTURED IN BETHLEHEM, PA CALCIUM CARBONATE GRANULATION WITH MALTODEXTRIN AS MANUFACTURED IN MODESTO, CA CALCIUM CARBONATE GRANULATION WITH ACACIA GUM AND MALTODEXTRIN AS MANUFACTURED IN MODESTO, CA CALCIUM CARBONATE GRANULATION WITH ACACIA GUM AS MANUFACTURED IN MODESTO, CA

Page 722

4Q2012EXCEL DMF# 23718 A 23719 23720 23721 23722 A 23723 23724 A 23725 A 23726 A 23727 A 23728 23729 23730 23731 23732 23733 23734 A 23735 23736 23737 23738 23739 A 23740 23741 A 23742 23743 23744 A 23745 23746 23747 A 23748 A II 4/26/2010 TEVA PHARMACEUTICALS INDUSTRIES LTD A A II II II 4/23/2010 4/26/2010 4/26/2010 SANDOZ PRIVATE LTD APOTEX PHARMACHEM INC MSN LABORATORIES LTD A A II II II 4/22/2010 4/13/2010 3/18/2010 DERIVADOS QUIMICOS SA FINE CHEMICALS BUPROPION HYDROCHLORIDE AS MANUFACTURED IN MURICA, SPAIN RAKS PHARMA PVT LTD ULKAR KIMYA SANAYI VE TICARET AS CARVEDILOL USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA A II II 4/22/2010 4/20/2010 CALAIRE CHIMIE SAS ALP PHARM BEIJING CO LTD A A A A II II II II II 4/21/2010 4/16/2010 4/26/2010 4/17/2010 4/21/2010 FORMOSA LABORATORIES INC LAURUS LABS PRIVATE LTD APICORE LLC MACLEODS PHARMACEUTICALS LTD MEGAFINE PHARMA P LTD A P A A A A IV IV IV IV II 4/20/2010 4/20/2010 4/20/2010 5/7/2010 4/14/2010 II 4/19/2010 II 1/5/2010 SICHUAN NEIJIANG HUIXIN PHARMACEUTICAL CO LTD MEDICHEM SA *** PENDING FILING REVIEW *** FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC ISP PHARMA SYSTEMS LLC HAINAN POLY PHARMACEUTICAL CO LTD 825.572 CHERRY FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL 815.153 BUBBLEGUM FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL 803.0048U CANDY APPPLE FLAVOR, ART AS MANUFACTURED IN GENEVA, IL ALPHA-TOCOPHEROL/PEG POWDER AS MANUFACTURED IN COLUMBIA, MD ASPIRIN AND DIPYRIDAMOLE EXTENDED RELEASE PELLETS CAPSULES AS MANUFACTURED IN HAINAN PROVINCE, P. R. OF CHINA CALCIUM ACETATE AS MANUFACTURED IN TAOYUAN, TAIWAN MONTELUKAST SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA II 4/14/2010 HAINAN POLY PHARMACEUTICAL CO LTD II 4/14/2010 HAINAN POLY PHARMACEUTICAL CO LTD I II II 4/29/2010 4/14/2010 UNIMARK REMEDIES LTD HAINAN POLY PHARMACEUTICAL CO LTD A A A II IV II II 6/4/2010 4/16/2010 4/16/2010 4/19/2010 ARCH PHARMALABS LTD ROQUETTE FRERES TRIFARMA SPA MSN LABORATORIES LTD STATUS Type SUBMIT DATE II 4/13/2010 HOLDER JM HUBER CORP SUBJECT

4Q2012

CALCIUM CARBONATE GRANULATION WITH STARCH AS MANUFACTURED IN MODESTO, CA BENZTROPINE MESYLATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA PEARLITOL FLASH AS MANUFACTURED IN LESTREM FRANCE GANCICLOVIR, USP AS MANUFACTURED IN LAGHETTO (MB), ITALY DEXLANSOPRAZOLE ANHYDROUS [ROUTE CODE- DZ] AS MANUFACTURED IN ANDHRA PRADESH, INDIA PROPOFOL USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA FELODIPINE EXTENDED RELEASE TABLETS AS MANUFACTURED IN HAINAN PROVINCE, P. R. OF CHINA TRIMEBUTINE MALEATE TABLETS AS MANUFACTURED IN HAINAN PROVINCE, P. R. OF CHINA METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS AS MANUFACTURED IN HAINAN PROVINCE, P. R. OF CHINA VITAMIN D2 AS MANUFACTURED IN SICHUAN, P.R. CHINA MED-201890/E AS MANUFACTURED IN CELRA (GIRONA), SPAIN

AZATHIOPRINE USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA FOR APICORE LLC RISEDRONATE SODIUM AS MANUFACTURED IN GUJARAT, INDIA ZIPRASIDONE HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN NASHIK, INDIA LAMOTRIGINE ACTIVE INGREDIENT AS MANUFACTURED IN CEDEX, FRANCE TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN JIANGSU PROVINCE, P.R. CHINA

PANTAPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN TEKIRDAG, TURKEY MOXIFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA RASAGILINE MESYLATE AS MANUFACTURED IN KARNATAKA, INDIA SOLIFENACIN SUCCINATE [ROUTE CODE SF] AS MANUFACTURED IN ANDHRA PRADESH, INDIA ROSIGLITAZONE MALEATE AS MANUFACTURED IN ZAGREB, CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD

Page 723

4Q2012EXCEL DMF# 23749 A 23750 23751 23752 23753 23754 A 23755 23756 23757 23758 23759 A 23760 23761 23762 A 23763 23764 A 23765 A 23766 23767 23768 23769 A 23770 23771 A 23772 23773 23774 23775 23776 A 23777 A 23778 A 23779 A IV 4/29/2010 III 4/28/2010 II 4/29/2010 A A A A III II II II II 6/4/2010 4/28/2010 5/5/2010 5/12/2010 5/3/2010 URSATECH VERPACKUNG GMBH LAURUS LABS PRIVATE LTD APOTEX PHARMACHEM INDIA PVT LTD UNIMARK REMEDIES LTD SYNCORE BIOTECHNOLOGY CO LTD A III III 5/4/2010 4/28/2010 ASAHI KASEI CHEMICALS CORP COLORTECH INC A A A II III II II 4/27/2010 4/29/2010 5/3/2010 5/3/2010 III 4/21/2010 A II II 4/21/2010 4/26/2010 HUBEI HAOSUN PHARMACEUTICAL CO LTD SHANGHAI WHYTE ASIA PIONEER PHARMACEUTICALS LTD RUBY SURGICAL AND ALLIED PRODUCTS PRIVATE LTD MYLAN LABORATORIES LTD POREX CORP EMCURE PHARMACEUTICALS LTD ZHUHAI UNITED LABORATORIES CO LTD A A II II II 9/15/2010 4/28/2010 4/20/2010 IPCA LABORATORIES LTD AVANTI POLAR LIPIDS INC HEC PHARM CO TORSEMIDE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA CHOLESTEROL (SEMI-SYNTHETIC) AS MANUFACTURED IN ALABASTER, AL A A A A II II II II II 4/28/2010 4/14/2010 4/14/2010 8/18/2010 8/13/2010 ALBEMARLE CORP RESONANCE LABORATORIES PVT LTD RESONANCE LABORATORIES PVT LTD IPCA LABORATORIES LTD IPCA LABORATORIES LTD A A A A IV IV II IV II 4/23/2010 4/23/2010 4/19/2010 4/26/2010 4/29/2010 STATUS Type SUBMIT DATE II 4/20/2010 HOLDER SUBJECT

4Q2012

SUPREEM PHARMACEUTICALS MYSORE PVT VITAMIN D3 (CHOLECALCIFEROL) WATER SOLUBLE 100 IU/MG AS MANUFACTURED IN LTD MYSORE, INDIA UNGERER AND CO NATURAL PEPPERMINT FLAVOR FT-3494 AS MANUFACTURED IN BETHLEHEM, PA UNGERER AND CO AREVIPHARMA GMBH NUSIL TECHNOLOGY LLC GRUNENTHAL GMBH NATURAL CITRUS WONF FLAVOR FT-2811 AS MANUFACTURED IN BETHLEHEM, PA SOTALOL HYDROCHLORIDE AS MANUFACTURED IN RADEBEUL, GERMANY DDR-4355 SILICONE GEL AS MANUFACTURED IN CARPINTERIA, CA EXTENDED-RELEASE OXYMORPHONE HYDROCHLORIDE TABLETS AS MANUFACTURED IN HORSHAM, PA FOR GRUNENTHAL GMBH IBUPROFEN SODIUM DIHYDRATE AS MANUFACTURED IN ORANGEBURG, SC BUPRENORPHINE HYDROCHLORIDE (BPNH) AS MANUFACTURED IN BANGALORE, INDIA OXYBUTYNIN CHLORIDE (OBTN) AS MANUFACTURED IN BANGALORE, INDIA ONDANSETRON USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA RISEDRONATE SODIUM HEMI-PENTAHYDRATE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA

ZIDOVUDINE, NON-STERILE DRUG SUBSTANCE, BULK FORM AS MANUFACTURED IN HUBEI PROVINCE, P.R. CHINA FOR HEC PHARMA CO DASATINIB AS MANUFACTURED IN HUBEI, P.R. CHINA 7-AMINO DESACETOXY CEPHALOSPORANIC ACID (7-ADCA) AS MANUFACTURED SHANGHAI, P.R. CHINA PURIFIED RAYON/ RAYON COILS AS MANUFACTURED IN JALGAON, INDIA ROSUVASTATIN CALCIUM AS MANUDFACTURED IN ANDHRA PRADESH, INDIA APPLICATOR TIP PART NUMBER 41505 AS MANUFACTURED IN FAIRBURN, GA ZOLEDRONIC ACID AS MANUFACTURED IN MAHARASHTRA, INDIA SULBACTAM SODIUM USP, NON-STERILE AS MANUFACTURED IN GUANGDONG, P.R. CHINA BARRIALON-UB M0651 AS MANUFACTURED IN SUZUKA-CITY, JAPAN 10296-16 NATURAL ANTIBLOCK POLYETHLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN AND BRAMPTON, ONTARIO, CANADA 3K-SYSTEM (ESUB) AS MANUFACTURED IN ST WENDEL GERMANY EMTRICITABINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA VARENICLINE TARTRATE AS MANUFACTURED IN KARNATAKA, INDIA CANDESARTAN CILEXETIL (ESUB) AS MANUFACTURED IN GUJARAT INDIA SCB01A (6-METHOXY-3-(3, 4, 5-TRIMETHOXYBENZOYL) INDOLE) AS MANUFACTURED IN SHAN-HUA, TAINAN COUNTY, TAIWAN R.O.C. FOR SYNCORE BIOTECHNOLOGY CO LTD

PRODUCTOS QUIMICOS MONTERREY SA DE POTASSIUM NITRATE USP AS MANUFACTURED IN SANTA CATARINA NUEVO LEON, CV MEXICO COLORTECH INC 10868-12 SLIP/ANTIBLOCK POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN AND BRAMPTON, ONTARIO, CANADA ADHESIVES RESEARCH INC TD-17B (A4775) AS MANUFACTURED IN GLEN ROCK, PA

Page 724

4Q2012EXCEL DMF# 23780 23781 A 23782 23783 23784 A 23785 23786 A 23787 A 23788 II 6/24/2010 JANSSEN PHARMACEUTICA NV II 6/24/2010 JANSSEN PHARMACEUTICA NV A II II 3/18/2010 4/30/2010 ULKAR KIMYA SANAYI VE TICARET AS ALP PHARM BEIJING CO LTD A A V III II 4/23/2010 5/5/2010 4/30/2010 PATHEON ITALIA SPA THE POLYOLEFIN CO SINGAPORE PTE LTD LIFE TECHNOLOGIES CORP STATUS Type SUBMIT DATE N IV 4/30/2010 HOLDER NOT AN ASSIGNED NUMBER 3M DRUG DELIVERY SYSTEMS SUBJECT

4Q2012

SOLVATED ACRYLATE COPOLYMER ADHESIVE R-27149 AS MANUFACTURED IN CORDOVA, IL STERILE AREA 2 DEPARTMENT LOCATED IN MONZA (MB), ITALY COSMOPLENE W331 AS MANUFACTURED IN SINGAPORE MYCOSEQ MYCOPLASMA DETECTION SYSTEM AS MANUFACTURED IN WARRINGTON, GREAT BRITAIN LANSOPRAZOLE AS MANUFACTURED IN TEKIRDAG, TURKEY EPTIFIBATIDE (DRUG SUBSTANCE, NON-STERILE, INJECTABLE) AS MANUFACTURED IN SHANGHAI, P.R. CHINA FOR ALP PHARM BEIJING CO LTD TELAPREVIR DRUG SUBSTANCE (R600109) (ESUB) AS MANUFACTURED IN GEEL BELGIUM AND BEERSE BELGIUM FOR JANSSEN PHARMACEUTICA NV TELAPREVIR SPRAY DRIED DISPERSION (INTERMEDIATE DRUG PRODUCT) (ESUB) AS MANUFACTURED IN GEEL BELGIUM AND BEERSE BELGIUM FOR JANSSEN PHARMACEUTICA NV BRINZOLAMIDE USP (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN SHANGDONG, P.R. CHINA FOR ALP PHARM BEIJING CO LTD EPROSARTAN MESILATE AS MANUFACTURED IN ANDHRA PRADESH INDIA VARENICLINE TARTRATE MALTODEXTRIN PREMIX (1:10) [DRUG SUBSTANCE (NONSTERILE)] AS MANUFACTURED IN TAMIL NADU INDIA NITAZOXANIDE AS MANUFACTURED IN SARONNO (VARESE) ITALY POVIDONE IODINE USP AS MANUFACTURED IN GUJARAT INDIA STAT-LOY * PRODUCTS AS MANUFACTURED IN THORNDALE, PENNSYLVANIA (USA), COLUMBUS INDIANA (USA), AND SAN LUIS POTOSI, MEXICO DORZOLAMIDE HYDROCHLORIDE USP AS MANUFACTURED IN TALKUKA KHALAPUR, DISTRICT RAIGAD, INDIA IMIPENEM AND CILASTATIN FOR INJECTION STERILE BULK (ESUB) AS MANUFACTURED IN JIANGSU CHINA POLYSULFATED GLYCOSAMINOGLYCAN (PSGAG) AS MANUFACTURED IN ALTKIRCH CEDEX,FRANCE EMBOSSED CPP FILM AS MANUFACTURED IN SHIGA-PREF., JAPAN FOR OG CORPORATION (PACKAGING MATERIAL) ACTIVATOR CAP AS MANUFACTURED IN PEACHTREE CITY, GA STERILE MANUFACTURING FACILITY LOCATED IN ROCHESTER, MI GEMCITABINE HYDROCHLORIDE USP (CODE: GMI) (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA SODIUM ACETATE TRIHYDRATE AS MANUFACTURED IN DARMSTADT, GERMANY SV-16450 AS MANUFACTURED IN KALKASKA MI ENTACAPONE AS MANUFACTURED IN HSIN-YING, TAIWAN R.O.C. GRANULATED MAGNESIUM CARBONATE: SCORAMAG DC 90ST AS MANUFACTURED IN CAFFIERS,FRANCE

A 23789 A 23790 23791 A 23792 23793 23794 A 23795 A 23796 A 23797 I 23798 A 23799 A 23800 23801 A 23802 23803 23804 A 23805 A II 5/14/2010 A A II III II 5/13/2010 9/29/2010 5/11/2010 MERCK KGAA CODING PRODUCTS STANDARD CHEMICAL AND PHARMACEUTICAL CO LTD SCORA SA A V II 4/20/2010 5/26/2010 JHP PHARMACEUTICALS LLC ARCH PHARMALABS LTD III 5/10/2010 GERRESHEIMER PEACHTREE CITY III 4/2/2010 OG CORP II 5/11/2010 II 7/9/2010 SUZHOU HOMESUN WANQING PHARMACEUTICAL CO LTD DAIICHI SANKYO ALTKIRCH SARL II 5/5/2010 INDOCO REMEDIES LTD A A II II III 5/6/2010 4/5/2010 6/4/2010 A II II 4/30/2010 5/6/2010 GLOCHEM INDUSTRIES LTD ACTAVIS PHARMA MANUFACTURING PRIVATE LTD INDUSTRIALE CHIMICA SRL RN LABORATORIES PVT LTD SABIC INNOVATIVE PLASTICS II 4/22/2010 ALP PHARM BEIJING CO LTD

Page 725

4Q2012EXCEL DMF# 23806 A 23807 23808 A 23809 I 23810 23811 23812 23813 23814 A 23815 23816 23817 A A II IV II 5/12/2010 5/15/2010 12/23/2010 PHARMAZELL INDIA PRIVATE LTD GANGWAL CHEMICALS PVT LTD RANBAXY LABORATORIES LTD A A A A II II IV II II 5/18/2010 5/14/2010 5/12/2010 5/18/2010 5/20/2010 GADOR SA SIFAVITOR SRL MB SUGARS AND PHARMACEUTICALS LTD FDC LTD AUROBINDO PHARMA LTD II 5/25/2010 RELIANCE LIFE SCIENCES PVT LTD ESZOPICLONE (ESUB) AS MANUFACTURED IN NAVI MUMBAI INDIA A III II 5/7/2010 5/25/2010 STATUS Type SUBMIT DATE III 5/12/2010 HOLDER YANGZHONG HONG YUAN PHARMACEUTICAL PACKAGING CO LTD KOREA ALUMINIUM CO LTD RELIANCE LIFE SCIENCES PVT LTD SUBJECT

4Q2012

PACKAGING MATERIALS AND COMPONENTS FOR PARENTERAL DRUG AND BIOLOGICAL PRODUCTS AS MANUFACTURED IN JIANGSU PROVINCE, P.R. CHINA PACKAGING MATERIAL AS MANUFACTURED IN CHUNG-BUK, KOREA CAPECITABINE USP (ESUB) AS MANUFACTURED IN NAVI MUMBAI INDIA

DUTASTERIDE AS MANUFACTURED IN PROVINCIA DE BUENOS AIRES, ARGENTINE PIPAMPERONE DIHYDROCHLORIDE AS MANUFACTURED IN LODI, ITALY SUCROSE USP NF AS MANUFACTURED IN NASIK, MAHARASHTRA, INDIA LATANOPROST AS MANUFACTURED IN MUMBAI MAHARASHTRA STATE, INDIA RIZATRIPTAN BENZOATE (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA N-ACETYLTYROSINE AS MANUFACTURED IN TAMBARAM CHENNAI, INDIA HYDROXYPROPYL BETADEX AS MANUFACTURED IN BOISAR, INDIA BOSENTAN MONOHYDRATE (ESUB) AS MANUFACTURED IN PUNJAB INDIA

A 23818 23819 A 23820 A 23821 A 23822 23823 A 23824 A 23825 A 23826 A 23827 A 23828 A 23829 A II 5/10/2010 V 5/12/2010 STRIDES ARCOLAB LTD SPECIALTY FORMULATION FACILITY ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD II 5/21/2010 CATALENT PHARMA SOLUTIONS LLC III 5/17/2010 MARUTO SANGYO CO LTD III 5/11/2010 MARUTO SANGYO CO LTD MEL, A BACKING LINER FOR TRANSDERMAL DRUG DELIVERY PATCHES AS MANUFACTURED IN FUKUOKA JAPAN MAP, A SACHET FOR TRANSDERMAL DRUG DELIVERY PATCHES AS MANUFACTURED IN FUKUOKA JAPAN PROGESTERONE SOFT GELATIN CAPSULES 100 MG AND 200 MG AS MANUFACTURED IN ST PETERSBURG FL PROCEDURE FOR STERILE OPERATIONS IN SPECIALTY FORMULATION FACILITY (SFF) AS LOCATED IN BANGALORE INDIA TELMISARTAN API AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA II 7/19/2010 JANSSEN PHARMACEUTICA NV A II II 5/20/2010 5/20/2010 HETERO DRUGS LTD ISOCHEM SAS III 5/19/2010 DAI NIPPON PRINTING CO LTD II 5/19/2010 CRYSTAL PHARMA SAU A IV II 5/7/2010 5/19/2010 DOW CORNING CORP CHIRAL BIOSCIENCES LTD DOW CORNING E70 LIQUID SILICONE RUBBER AS MANUFACTURED IN HEMLOCK, MI (S)-5-CHLORO-ALPHA-(CYCLOPROPYLETHYNYL)-2-AMINO-ALPHA-(TRIFLUOROMETHYL) BENZENE METHANOL AS MANUFACTURED IN KARNATAKA, INDIA AND ANDHRA PRADESH, INDIA METHYLPREDNISOLONE ACETATE STERILE MICRONIZED AS MANUFACTURED IN BOECILLO (VALLADOLID), SPAIN IB FILM AS MANUFACTURED IN FUKUSHIMA PREF., JAPAN FOR DAI NIPPON PRINTING CO LTD FAMCICLOVIR AS MANUFACTURED IN ANDHRA PRADESH, INDIA VITAMIN E POLYETHYLENE GLYCOL SUCCINATE AS MANUFACTURED IN GENNEVILLIERS, FRANCE RILPIVIRINE HYDROCHLORIDE (R314585) DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN GEEL BELGIUM AND COUNTY CORK IRELAND FOR JANSSEN PHARMACEUTICA NV

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4Q2012EXCEL DMF# 23830 A 23831 A 23832 23833 23834 A 23835 A 23836 23837 23838 23839 23840 A 23841 A 23842 A 23843 23844 A 23845 23846 A 23847 A 23848 A 23849 A 23850 23851 23852 23853 A 23854 23855 23856 A 23857 A 23858 A II 5/28/2010 ZHUHAI UNITED LABORATORIES CO LTD III 5/19/2010 A A II II II 6/2/2010 6/3/2010 5/27/2010 A A A II III II II 2/10/2011 4/29/2010 5/24/2010 6/2/2010 LUPIN LTD PLASTICON INDUSTRIAL LTD PCAS ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD HETERO LABS LTD HARMAN FINOCHEM LTD PRODUCTOS QUIMICOS NATURALES SA DE CV INGENIA POLYMERS CORP III 6/1/2010 OKURA INDUSTRIAL CO LTD II 5/10/2010 LUSOCHIMICA SPA II 5/20/2010 ALP PHARM BEIJING CO LTD A II III 5/25/2010 5/24/2010 XELLIA PHARMACEUTICALS APS AMPACET CORP A II II 5/24/2010 6/3/2010 MACLEODS PHARMACEUTICALS LTD SIGMAPHARM LABORATORIES LLC II 5/27/2010 III 5/17/2010 JIANGSU ZHONGJIN MATAI MEDICINAL PACKAGING CO LTD CATALENT PHARMA SOLUTIONS LLC A A A A II II II II V 5/18/2010 6/2/2010 6/17/2010 4/19/2010 6/9/2010 VALDEPHARM UNIMARK REMEDIES LTD BGP HEALTHCARE PRIVATE LTD GLAND PHARMA LTD NOVOCOL PHARMACEUTICAL CANADA INC ESTRADIOL BENZOATE (ESUB) AS MANUFACTURED IN VAL DE REUIL, FRANCE II 6/4/2010 UNICHEM LABORATORIES LTD A A II II II 5/25/2010 5/26/2010 6/3/2010 CYALUME SPECIALTY PRODUCTS INC SMS PHARMACEUTICALS LTD UNICHEM LABORATORIES LTD II 5/24/2010 STATUS Type SUBMIT DATE II 5/24/2010 HOLDER ACTAVIS PHARMA MANUFACTURING PRIVATE LTD JIANGSU HENGRUI MEDICINE CO LTD SUBJECT

4Q2012

PALIPERIDONE DRUG SUBSTANCE (NON-STERILE) AS MANUFACTURED IN TAMIL NADU, INDIA LETROZOLE USP NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU CHINA ISOMETHEPTENE MUCATE, USP AS MANUFACTURED IN BOUND BROOK, NJ GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA EPROSARTAN MESYLATE (ESUB) AS MANUFACTURED IN PITHAMPUR DISTRIC - DHAR (M.P.), INDIA IRBESARTAN API (ESUB) AS MANUFACTURED IN PITHAMPUR DISTRICT DHAR (MP) INDIA

MONTELUKAST SODIUM (PROCESS A) (ESUB) AS MANUFACTURED IN GUJARAT INDIA NICOTINE POLACRILEX USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA HEPARIN SODIUM USP, AS MANUFACTURED IN ANDHRA PRADESH, INDIA NOVOCOL PHARMACEUTICAL OF CANADA INC STERILE MANUFACTURING VALIDATION (ESUB) AS LOCATED IN ONTARIO CANADA ALUMINIUM FOILS PACKAGING FOR MEDICINE AS MANUFACTURED IN JIANGSU PROVINCE, P.R. CHINA DRONABINOL CAPSULES USP 2.5MG, 5.0MG, 10.0MG (CIII) SA MANUFACTURED IN SOMERSET, NJ TOLTERODINE TARTRATE AS MANUFACTURED IN GUJARAT, INDIA AMORPHOUS ADEFOVIR DIPIVOXIL (11.6% COPOVIDONE DISPERSION) (ESUB) AS MANUFACTURED IN BENSALEM, PA MUPIROCIN USP, NON-STERILE AS MANUFACTURED IN TAIZHOU ZHEJIANG, P.R. CHINA 482521 BEIGE SLIP PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA AND HEATH, OH ZOLEDRONIC ACID AS MANUFACTURED IN SHANDONG, CHINA FOR ALP PHARMA BEIJING CO LTD FORMOTEROL FUMARATE DIHYDRATE AS MANUFACTURED IN PISA, ITALY AND LOMAGNA (LC), ITALY OKR EMBOSSED POLYPROPYLENE LINER AS MANUFACTURED IN KAGAWA PREFECTURE, JAPAN DARUNAVIR ETHANOLATE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA USA APPLICATOR AS MANUFACTURED IN TOKOL, HUNGARY DISOPYRAMIDE PHOSPHATE AS MANUFACTURED IN TURKU, FINLAND LEVETIRACETAM USP (PROCESS II) AS MANUFACTURED IN ZHEJIANG, P.R. CHINA DARUNAVIR AMORPHOUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA FENOFIBRIC ACID AS MANUFACTURED IN MAHARASHTRA, INDIA 17 ALPHA-ESTRADIOL AS MANUFACTURED IN IXTACZOQUITLAN, VER., MEXICO INGENIA POLYMERS 1020 FILLED WHITE FOR USE IN PACKAGING MATERIALS AS MANUFACTURED IN ONTARIO, CANADA; ALBERTA, CANADA AND HOUSTON, TEXAS MEROPENEM USP, NON-STERILE AS MANUFACTURED IN GUANGDONG, P.R. Page 727 CHINA

4Q2012EXCEL DMF# 23859 A 23860 23861 23862 A 23863 A 23864 A 23865 23866 A 23867 23868 23869 A 23870 A 23871 23872 A 23873 23874 A 23875 A 23876 23877 23878 A 23879 A 23880 A 23881 23882 A 23883 23884 A 23885 23886 23887 A A I II II II 4/29/2010 8/30/2010 6/15/2010 MELODY HEALTHCARE PVT LTD INDENA SPA SEQUENT SCIENTIFIC LTD A II II 8/4/2010 6/8/2010 MALLINCKRODT INC INDENA SPA A II IV 6/29/2010 6/9/2010 TORRENT PHARMACEUTICALS LTD UNGERER AND CO PALIPERIDONE (ESUB) AS MANUFACTURED IN GUJARAT INDIA II 6/9/2010 II 6/5/2010 A A II II II 5/31/2010 5/31/2010 5/31/2010 BIOTIKA AS AREVIPHARMA GMBH BIA SEPARATIONS DOO II 6/9/2010 TEVA PHARMACEUTICAL INDUSTRIES LTD A II IV 6/10/2010 6/9/2010 A II II 11/29/2010 6/10/2010 CADILA PHARMACEUTICALS LTD YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD MYLAN LABORATORIES LTD EVONIK INDUSTRIES AG II 7/20/2010 A P IV 6/7/2010 II 6/4/2010 A II II 6/7/2010 6/28/2010 HETERO DRUGS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD EUTICALS SPA *** PENDING FILING REVIEW *** XIANGSHAN JINAN IMPORT & EXPORT CO LTD TRIS PHARMA INC II 6/3/2010 MSN PHARMACHEM PVT LTD II 6/28/2010 APICORE LLC FONDAPARINUX SODIUM (ESUB) AS MANUFACTURED IN SOMERSET NJ A A II IV II 6/4/2010 6/4/2010 5/20/2010 CADILA HEALTHCARE LTD FONA INTERNATIONAL INC STATUS Type SUBMIT DATE II 5/27/2010 HOLDER MYLAN LABORATORIES LTD SUBJECT

4Q2012

VALGANCICLOVIR HYDROCHLORIDE USP (AMORPHOUS) ( ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA BENZOYL PEROXIDE HYDROUS (ESUB) AS MANUFACTURED IN GUJARAT, INDIA 805.219 BANANA FLAVOR, NAT WONF AS MANUFACUTERED IN GENEVA, IL

ST GOBAIN PERFORMANCE PLASTICS CORP TYGON 3350 SILICONE TUBING AS MANUFACUTRED IN BANGALORE, INDIA

SITAGLIPTIN PHOSPHATE MONOHYDRATE (ROUTE CODE SG) AS MANUFACUTRED IN ANDHRA PRADESH, INDIA LEVOFLOXACIN HEMIHYDRATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA ISA (INTERMEDIATE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA FOR ORCHID CHEMICALS & PHARMACEUTICALS LTD SODIUM MYCOPHENOLATE AS MANUFACTURED IN ROZZANO (MI) ITALY HARD EMPTY GELATIN CAPSULES AS MANUFACTURED IN ZHEJIANG, P.R. CHINA METHYLPHENIDATE ERL (METHYLPHENIDATE ER POWDER FOR ORAL SUSPENSION) (ESUB) AS MANUFACTURED IN MONMOUTH JUNCTION NJ PALIPERIDONE (ESUB) AS MANUFACTURED IN GUJARAT INDIA CEPHALEXIN USP YUNG SHIN AS MANUFACTURED IN TAICHUNG, TAIWAN, R.O.C. DARUNAVIR AS MANUFACUTRED IN ANDHRA PRADESH, INDIA RESOMER R SR FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN INGELHEIM, GERMANY FLUOCINOLONE ACETONIDE (PROCESS II) AS MANUFACTURED IN RHO MILAN ITALY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD POLYMYXIN B SULFATE AS MANUFACTURED IN SLOVENSKA LUPCA, SLOVAKIA METAXALONE AS MANUFACTURED IN RADEBEUL, GERMANY

CIM CONVECTIVE INTERACTION MEDIA SO3 AS MANUFACTURED IN LJUBLJANA, SLOVENIA TRACE LIFE SCIENCES INC SODIUM IODINE (I-123) DRY IODINE RADIOCHEMICAL AS MAUNFACTURED IN DENTAON, TX CENTAUR PHARMACEUTICALS PRIVATE LTD BRIMONIDINE TARTRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

NATURAL AND ARTIFICIAL ORANGE FLVP FO-9464 AS MANUFACTURED IN BETHLEHEM, PA OPIUM TINCTURE 2% (ESUB) AS MANUFACTURED IN ST LOUIS MO N-DEBOC-DOCETAXEL (N-DEBENZOYL-10-DEACETYLPACLITAXEL INTERMEDIATE) AS MANUFACTURED IN SETTALA (MI), ITALY RAMIPRIL AS MANUFACTURED IN MAHARASHTRA, INDIA DOCETAXEL (ESUB) AS MANUFACTURED IN MILAN ITALY PRAZIQUANTEL AS MANUFACTURED IN KARNATAKA, INDIA

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4Q2012EXCEL DMF# 23888 A 23889 A 23890 23891 A 23892 A 23893 23894 A 23895 23896 23897 23898 23899 23900 A 23901 A 23902 A 23903 23904 A 23905 A 23906 23907 23908 23909 23910 A 23911 A 23912 23913 A 23914 23915 23916 A A A II II II 6/23/2010 6/23/2010 6/25/2010 INKE SA RAKS PHARMA PVT LTD CRYSTAL PHARMA SAU A IV III 6/21/2010 6/18/2010 TERRENE PHARMA PVT LTD DYNEON GMBH II 7/7/2010 A I A A II II II II II 6/14/2010 6/8/2010 6/18/2010 6/18/2010 6/23/2010 YUNG ZIP CHEMICAL IND CO LTD SINTENOVO SA DE CV PCAS YUNG ZIP CHEMICAL IND CO LTD ACTAVIS PHARMA MANUFACTURING PRIVATE LTD BASF PHARMA CALLANISH LTD II 7/12/2010 KD PHARMA BEXBACH GMBH A IV III 6/22/2010 6/18/2010 FONA INTERNATIONAL INC AMPACET CORP 825.0275U CHERRY FLAVOR NAT & ART AS MANUFACTURED IN GENEVA IL II 7/2/2010 NOVARTIS PHARMACEUTICALS CORP II 6/30/2010 NOVARTIS PHARMACEUTICALS CORP A A A A A II II II II II II 6/18/2010 6/18/2010 7/7/2010 6/29/2010 6/18/2010 6/22/2010 NEULAND LABORATORIES LTD APOTEX PHARMACHEM INDIA PVT LTD CML EUROPE BV AUROBINDO PHARMA LTD SYMBIOTEC PHARMALAB LTD MSN LABORATORIES LTD A III III 6/16/2010 6/15/2010 FLOW DRY TECHNOLOGY INC CORMACK PACKAGING PTY LTD II 6/7/2010 A II II 4/27/2010 6/29/2010 BRIDGE ORGANICS CO ORCHID CHEMICALS AND PHARMACEUTICALS LTD BIOCON LTD II 6/15/2010 MSN PHARMACHEM PVT LTD STATUS Type SUBMIT DATE II 6/8/2010 HOLDER CHEMAGIS LTD SUBJECT

4Q2012

MOMETASONE FUROATE MONOHYDRATE AS MANUFACTURED IN BEER SHEVA, ISRAEL OSELTAMIVIR PHOSPHATE [ROUTE CODE: OT] AS MANUFACTURED IN ANDHRA PRADESH, INDIA CRYSTALLINE LACTONEDIOL AS MANUFACTURED IN VICKSBURG, MI CEFUROXIME AXETIL (CRYSTALLINE) (NON-STERILE BULK API) (ESUB) AS MANUFACTURED IN ALATHUR KANCHEEPURAM DISTRICT INDIA HUMAN INSULIN-BULK (RDNA ORIGIN) (ANIMAL ORIGIN FREE) AS MANUFACTURED IN BANGALORE, INDIA. DESICCANT PRODUCTS AS MANUFACTURED IN BELEN, NM CORMACK TAMPER EVIDENT (TE) CLOSURES AS MANUFACTURED IN NEW SOUTH WALES, AUSTRALIA PARICALCITOL, USP AS MANUFACTURED IN ANDHRA PRADESH INDIA ZOLMITRIPTAN AS MANUFACTURED IN KARNATAKA, INDIA MALATHION USP (ESUB) AS MANUFACTURED IN WEERT THE NETHERLANDS MODAFINIL USP (NON-STERILE DRUG SUBSTANCE) (ESUB) ANDHRA PRADESH INDIA PREDNISOLONE SODIUM PHOSPHATE USP AS MANUFACTURED IN INDORE, INDIA PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE [ROUTE CODE PP] AS MANUFACTURED IN ANDHRA PRADESH, INDIA FLUVASTATIN DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN RINGASKIDDY CO CORK IRELAND FOR NOVARTIS PHARMACEUTICAL CORPORATION VALSARTAN DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN RINGASKIDDY CO CORK IRELAND FOR NOVARTIS PHARMACEUTICAL CORPORATION

474187 GREEN PP MB AS MANUFACTURED IN DERRIDER LA, CATERSVILLE GA, HEATH OH, AND TERRE HAUTE IN OMEGA-3-ACIDS ETHYL ESTER (ESUB) AS MANUFACTURED IN BEXBACH GERMANY CLONIDINE HYDROCHLORIDE AS MANUFACTURED IN TACHIA TAICHUNG TAIWAN ROC RABEPRAZOLE SODIUM AS MANUFACTURED IN JUAREZ MEXICO OLOPATADINE HCI AS MANUFACTURED IN TURKU FINLAND FOR PCAS DICLOFENAC EPOLAMINE AS MANUFACTURED IN TACHIA TAICHUNG TAIWAN ROC CINACALCET HYDROCHLORIDE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU, INDIA EICOSAPENTAENOIC ACID ETHYL ESTER (EPA-E) (ESUB) AS MANUFACTURED IN ISLE OF LEWIS SCOTLAND UK EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN GUJARAT, INDIA IMPROVED PFA POLYMER DISPERSIONS AS MANUFACTURED IN BURGKIRCHEN, GERMANY SALMETEROL XINAFOATE AS MANUFACTURED IN (BARCELONA) SPAIN DIVALPROEX SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA MOMETASONE FUROATE MICRONIZED AS MANUFACTURED IN BOECILLO (VALLADOLID), SPAIN Page 729

4Q2012EXCEL DMF# 23917 A 23918 A 23919 A 23920 23921 23922 23923 23924 23925 23926 23927 23928 A 23929 23930 A 23931 23932 A 23933 23934 A 23935 A 23936 A 23937 23938 23939 23940 23941 A 23942 A 23943 23944 23945 23946 A 23947 A II 6/14/2010 ZHEJIANG SUPOR PHARMACEUTICALS CO LTD A A A IV II II II 7/2/2010 7/6/2010 7/6/2010 7/6/2010 II 6/29/2010 ZHEJIANG XIANJU PHARMACEUTICAL CO LTD FONA INTERNATIONAL INC EMCURE PHARMACEUTICALS LTD MSN LABORATORIES LTD RANBAXY LABORATORIES LTD A A A A II IV II II II 6/30/2010 7/2/2010 6/29/2010 6/28/2010 7/2/2010 RA CHEM PHARMA LTD COMED CHEMICALS LTD SMRUTHI ORGANICS LTD APOTEX PHARMACHEM INDIA PVT LTD ENTACAPONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN GUJARAT, INDIA FENOFIBRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA II 7/1/2010 II 6/21/2010 A II II 6/30/2010 6/28/2010 ERREGIERRE SPA ZHEJIANG XIANJU PHARMACEUTICAL CO LTD FIDIA FARMACEUTICI SPA DIVISIONE SOLMAG KYOWA HAKKO KIRIN CO LTD A III III 6/30/2010 6/29/2010 CORADIN SAS MITSUBISHI PLASTICS INC DUAL VIALS SYSTEM AS MANUFACTURED IN MOUANS-SARTOUX, FRANCE A II II 6/25/2010 6/29/2010 PROVENTUS LIFE SCIENCES PVT LTD A A A A A A A A II II III II II II II II IV 6/28/2010 6/25/2010 6/28/2010 6/29/2010 8/5/2010 6/8/2010 6/25/2010 6/29/2010 6/23/2010 BIOVET JOINT STOCK CO STERLING SRL DYNIC USA TRACE LIFE SCIENCES INC APICORE LLC SHASUN PHARMACEUTICALS LTD HAINAN POLY PHARMACEUTICAL CO LTD MYLAN LABORATORIES LTD EVONIK INDUSTRIES AG IV 6/25/2010 ROQUETTE FRERES II 12/29/2010 APICORE LLC STATUS Type SUBMIT DATE IV 6/25/2010 HOLDER ROQUETTE FRERES SUBJECT PEA STARCH HYDROXYPROPYL PREGELATINIZED (LYCOAT+F23803 RS) AS MANUFACTURED IN LESTREM, FRANCE AND LENGRAIN, FRANCE CABERGOLINE (ESUB) AS MANUFACTURED IN SOMERSET NJ

4Q2012

PEA STARCH HYDROXYPROPYL (LYCOAT NG) AS MANUFACTURED IN LESTREM, FRANCE AND LENGRAIN, FRANCE TESTOSTERONE ENANTHATE AS MANUFACTURED IN PESHTERA, BULGARIA NOMEGESTROL ACETATE AS MANUFACTURED IN PERUGIA, ITALY HT13 THERMAL TRANSFER RIBBON AS MANUFACTURED IN HILLSBORO, OR INDIUM CHLORIDE (111IN) RADIOCHEMICAL AS MANUFACTURED IN DENTON, TX BUSULFAN USP (ESUB) AS MANUFACTURED IN SOMERSET NJ IBUPROFEN SODIUM DIHYDRATE AS MANUFACTURED IN CUDDALORE, INDIA DESLORATADINE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA ROSIGLITAZONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA RESOMER (R) RP D FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN INGELHEIM, GERMANY TROSPIUM CHLORIDE AS MANUFACTURED IN CHENNAI, INDIA

PHARMACEUTICAL WORKS POLPHARMA SA SILDENAFIL CITRATE AS MANUFACTURED STAROGARD GDANSKI, POLAND

TECHBARRIER SERIES AS MANUFACTURED IN KYOTO, JAPAN AND SHIGA, JAPAN FOR MITSUBISHI PLASTICS INC ENTACAPONE AS MANUFACTURED IN SAN PAOLO D ARGON (BG), ITALY TESTOSTERONE UNDECANOATE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA RITONAVIR AS MANUFACTURED IN MULAZZANO (LO), ITALY ISTRADEFYLLINE (KW-6002) DRUG SUBSTANCE AS MANUFACTURED IN OSAKA, JAPAN

DERIVADOS QUIMICOS SA FINE CHEMICALS SEVELAMER HYDROCHLORIDE AS MANUFACTURED IN MURCIA, SPAIN CANDESARTAN CILEXETIL AS MANUFACTURED IN BRANTFORD, CANADA AND BANGALORE, INDIA ESTRADIOL USP, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG P.R. CHINA 926.0425U N-C VANILLA FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL BENZPHETAMINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA PALIPERIDONE [ROUTE CODE-PA] AS MANUFACTURED IN ANDHRA PRADESH, INDIA VALGANCICLOVIR HYDROCHLORIDE, USP (PROCESS 2; SITE TOANSA) AS MANUFACTURED IN PUNJAB, INDIA MITOTANE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA

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4Q2012EXCEL DMF# 23948 23949 23950 A 23951 A 23952 A 23953 A 23954 A 23955 23956 A 23957 23958 23959 A 23960 23961 23962 23963 23964 23965 23966 A 23967 A 23968 A 23969 23970 A 23971 A 23972 A 23973 A 23974 A 23975 A II 7/15/2010 MSN LABORATORIES LTD II 7/6/2010 PORTON PHARMACEUTICAL LTD II 8/25/2010 WUHAN WUYAO PHARMACEUTICAL CO LTD II 10/25/2010 II 7/6/2010 CHONGQING FUAN PHARMACEUTICAL CO LTD SRI KRISHNA PHARMACEUTICALS LTD A III IV 7/1/2010 7/4/2010 II 7/9/2010 CALYX CHEMICALS AND PHARMACEUTICALS ARTEMETHER AS MANUFACTURED IN MAHARASHTRA INDIA LTD HMC POLYMERS CO LTD PURELL RP271G AS MANUFACTURED IN RAYONG THAILAND TOSAF COMPOUNDS LTD II 7/12/2010 A A A A A A II II II II IV II II 7/13/2010 7/13/2010 7/8/2010 7/12/2010 7/12/2010 7/28/2010 7/9/2010 EUTICALS SPA EUTICALS SPA CONCORD BIOTECH LTD SAURAV CHEMICALS LTD FONA INTERNATIONAL INC UNIMARK REMEDIES LTD A A III II II 6/30/2010 7/8/2010 5/21/2010 E SAENG TECHNOPACK CO LTD NORAC INC NTP RADIOISOTOPES PTY LTD A III III 7/7/2010 6/29/2010 II 7/7/2010 III 5/26/2010 III 5/26/2010 II 6/1/2010 ALP PHARM BEIJING CO LTD STATUS Type SUBMIT DATE A A II II IV 7/2/2010 6/18/2010 7/1/2010 HOLDER VALDEPHARM ALP PHARM BEIJING CO LTD UNGERER AND CO SUBJECT ESTRADIOL VALERATE AS MANUFACTURED IN VAL DE REUIL, FRANCE

4Q2012

IRINOTECAN HYDROCHLORIDE AS MANUFACTURED IN SICHUAN PROVINCE, P.R. CHINA NATURAL AND ARTIFICIAL LEMON FLVP FT-4174 AS MANUFACTURED IN BETHLEHEM, PA

VINORELBINE TARTRATE AS MANUFACTURED IN HUBEI PROVINCE, P.R. CHINA FOR ALP PHARM BEIJING CO LTD COLORTECH INC 11287-16 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN AND ONTARIO, CANADA COLORTECH INC 10505-14 KOSHER ANTIFOG POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TN AND ONTARIO, CANADA SOUTHWEST SYNTHETIC PHARMACEUTICAL ALLOPURINOL AS MANUFACTURED IN CHONGQING, P.R. CHINA CO LTD GEPACK SA PET PACKAGING AS MANUFACTURED IN AZAMBUJA, PORTUGAL COPE ALLMAN JAYCARE LTD 20ML POLYETHYLENE WHITE ROUND BOTTLE AS MANUFACTURED IN NEW CASTLE UPON TYNE, ENGLAND CONTAINER AND CLOSURE AS MANUFACTURED IN CHUNGNAM, KOREA RSN-01314 DRUG SUBSTANCE AS MANUFACTURED IN AZUSA, CA FISSION MOLYBDENUM-99 (PRODUCED FROM LOW ENRICHED URANIUM (LEU)) AS MANUFACTURED IN PRETORIA, REPUBLIC OF SOUTH AFRICA DIACEREIN (PROCESS I) AS MANUFACTURED IN LODI, ITALY DIACEREIN (PROCESS II) AS MANUFACTURED IN CASALETTO LODIGIANO, ITALY CYCLOSPORINE USP AS MANUFACTURED in AHMEDABAD, INDIA HOMATROPINE METHYLBROMIDE USP AS MANUFACTURED IN PUNJAB, INDIA 915.0113U STRAWBERRY FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL SOLIFENACIN SUCCINATE (ESUB) AS MANUFACTURED IN GUJARAT INDIA

CALYX CHEMICALS AND PHARMACEUTICALS LUMEFANTRINE AS MANUFACTURED IN MAHARASHTRA INDIA LTD ST GOBAIN PERFORMANCE PLASTICS CORP SANI-TECH STHT-C AS MANUFACTURED IN TAUNTON MA

EXCIPIENT, COLORANT, FLAVOR, ESSENCE, OR MATERIAL USED IN PREPARATION FOR TOSAF COMPOUNDS AS MANUFACTURED IN KEFAR YONA ISRAEL AZTREONAM USP (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN CHONGQING CHINA FOR G&A ASSOCIATES LLC SODIUM PHENYL BUTYRATE GRANULES 100% (ESUB) AS MANUFACTURED IN HYDERABAD INDIA ACAMPROSATE CALCIUM, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN WUHAN, CHINA CLINDAMYCIN PALMITATE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG AS MANUFACTURED IN CHONGQING, P.R. CHINA ROSUVASTATIN CALCIUM (ROUTE CODE RT) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

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4Q2012EXCEL DMF# 23976 A 23977 A 23978 23979 23980 23981 A 23982 23983 A 23984 23985 A 23986 A 23987 23988 23989 23990 23991 23992 23993 23994 A 23995 A 23996 23997 A 23998 A 23999 A 24000 A 24001 24002 A 24003 A 24004 24005 A N II 7/28/2010 II 7/27/2010 A IV II 7/27/2010 7/22/2010 GATTEFOSSE SAS II 7/2/2010 ALP PHARM BEIJING CO LTD II 7/2/2010 ALP PHARM BEIJING CO LTD II 7/20/2010 ALP PHARM BEIJING CO LTD A II II 7/26/2010 7/2/2010 DR REDDYS LABORATORIES LTD ALP PHARM BEIJING CO LTD BORTEZOMIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA II 7/30/2010 FRESENIUS KABI ONCOLOGY LTD A A A A A A A III III III II II II II II 7/23/2010 7/23/2010 7/23/2010 7/23/2010 7/22/2010 7/22/2010 7/26/2010 7/26/2010 SABIC PETROCHEMICALS BV SABIC PETROCHEMICALS BV SABIC PETROCHEMICALS BV DIVIS LABORATORIES LTD ROVI CONTRACT MANUFACTURING SL ROVI CONTRACT MANUFACTURING SL RANBAXY LABORATORIES LTD DR REDDYS LABORATORIES LTD III 7/21/2010 AMERICAS STYRENICS LLC A II II 7/13/2010 5/22/2010 A II III 7/20/2010 7/20/2010 A A A II II II III 7/19/2010 7/19/2010 7/19/2010 7/20/2010 FORMOSA LABORATORIES INC WUXI JIDA PHARMACEUTICAL CO LTD RAKS PHARMA PVT LTD ZAKLADY AZOTOWE W TARNOWIE MOSCICACH SA CADILA HEALTHCARE LTD ZAKLADY AZOTOWE W TARNOWIE MOSCICACH SA FIS FABBRICA ITALIANA SINTETICI SPA QILU PHARMACEUTICAL CO LTD ORLISTAT AS MANUFACTURED IN TAOYUAN TAIWAN II 7/14/2010 AARTI INDUSTRIES LTD STATUS Type SUBMIT DATE III 7/13/2010 HOLDER EVA FILSAKOVA VINAMET SUBJECT

4Q2012

HDPE BOTTLES FOR SOLID DOSAGE FORMS AS MANUFACTURED IN MISKOVICE, CZECH REPUBLIC MOMETASONE FUROATE MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA

CITALOPRAM HYDROBROMIDE AS MANUFACTURED IN JIANGSU PROVINCE CHINA METAXALONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA TARNOFORM 300 AS MANUFACTURED IN TARNOW, POLAND IRINOTECAN HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT INDIA TARNOFORM 500 AS MANUFACTURED IN TARNOW, POLAND ENTACAPONE AS MANUFACTURED IN VICENZA ITALY CISPLATIN (NON STERILE API) AS MANUFACTURED IN JINAN SHANDONG PROVINCE PEOPLES REPUBLIC OF CHINA GENERAL PURPOSE POLYSTYRENE (GPPS) RESINS AS MANUFACTURED IN GALES FERRY, CT; IRONTON, OH; CHANNAHON, IL; TORRANCE, CA AND MARIETTA, OH SABIC PP PCGH10 AS MANUFACTURED IN AI GELEEN, THE NETHERLANDS SABIC PP PCGH19 AS MANUFACTURED IN AI GELEEN, THE NETHERLANDS SABIC HDPE PCG80063 AS MANUFACTURED IN AI GELEEN, THE NETHERLANDS 2-4-WING ACTIVE ESTER AS MANUFACTURED IN ANDHRA PRADESH INDIA STERILE WATER FOR INJECTION USP 2.0 ML AS MANUFACTURED IN MADRID SPAIN STERILE WATER FOR INJECTION USP 0.5 ML AS MANUFACTURED IN MADRID SPAIN ADEFOVIR DIPIVOXIL AS MANUFACTURED IN PUNJAB, INDIA ESOMEPRAZOLE MAGNESIUM (AMORPHOUS)[PROCESS-2] AS MANUFACTURED IN ANDHRA PRADESH, INDIA CARBOPLATIN (ESUB) AS MANUFACTURED IN WEST BENGAL INDIA

POLYMYXIN B SULFATE USP AS MANUFACTURED IN JIANGSU, P.R. CHINA FOR ALP PHARM BEIJING CO LTD CALCITONON SALMON AS MANUFACTURED IN SHANGHAI, P.R. CHINA FOR ALP PHARM BEIJING CO LTD BACITRACIN AS MANUFACTURED IN JIANGSU, P.R. CHINA FOR ALP PHARM BEIJING CO LTD BACITRACIN ZINC AS MANUFACTURED IN JIANGSU, P.R. CHINA FOR ALP PHARM BEIJING CO LTD PLUROL OLEIQUE CC 497, AS MANUFACTURED IN SAINT-PRIEST CEDEX, FRANCE

CALYX CHEMICALS AND PHARMACEUTICALS HYDROXYZINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA LTD MSN PHARMACHEM PVT LTD MOXIFLOXACIN HYDROCHLORIDE (ANHYDROUS) [ROUTE CODE: MP] AS MANUFACTURED ANDHRA PRADESH, INDIA TORAY INDUSTRIES INC BPS-314d DRUG SUBSTANCE AS MANUFACTURED IN SHIZUOKA, JAPAN NOT AN ASSIGNED NUMBER

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4Q2012EXCEL DMF# 24006 A 24007 A 24008 24009 24010 24011 A 24012 24013 A 24014 24015 A 24016 A 24017 A 24018 A 24019 24020 A 24021 A 24022 24023 24024 24025 A 24026 24027 A 24028 24029 A 24030 24031 A 24032 24033 A 24034 N NOT AN ASSIGNED NUMBER A II II 8/4/2010 7/14/2010 A II II 8/4/2010 8/5/2010 EMCURE PHARMACEUTICALS LTD APOTEX PHARMACHEM INC A II III 8/5/2010 7/20/2010 SEQUENT SCIENTIFIC LTD STARPLASTIC INDUSTRY CO LTD A II II 8/2/2010 8/5/2010 MOEHS IBERICA SL KREATIVE ORGANICS P LTD A A A II II II III 8/4/2010 6/28/2010 8/10/2010 7/30/2010 II 7/20/2010 A II II 8/2/2010 8/11/2010 II 8/2/2010 II 7/26/2010 II 8/23/2010 A II II 7/23/2010 7/23/2010 3D IMAGING LLC P II 7/30/2010 *** PENDING FILING REVIEW *** ATON PHARMA INC A A A III II IV IV 7/29/2010 7/29/2010 7/27/2010 7/27/2010 II 7/20/2010 STATUS Type SUBMIT DATE IV 7/25/2010 HOLDER VIKRAM THERMO INDIA LTD SUBJECT

4Q2012

METHACRYLIC ACID COPOLYMER DISPERSION NF AS MANUFACTURED IN GUJARAT, INDIA CSPC CENWAY TIANJIN PHARMACEUTICALS 7-AVCA AS MANUFACTURED IN TIANJIN P.R. CHINA CO LTD TORAY INDUSTRIES INC NYLON 6/66 RESIN T-1200P AS MANUFACTURED IN NAGOYA, JAPAN MYLAN LABORATORIES LTD LONZA INC HENKEL CORP EPROSARTAN MESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA GLYCOMUL TS KFG AS MANUFACTURED IN WILLIAMSPORT, PA DURO-TAK (TM) 87-905A PRESSURE SENSITIVE ADHESIVE AS MANUFACUTRED IN SALISBURY, NC PENICILLAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR ATON PHARMA INC [I-124] FIAU (FIALURIDINE) AS MANUFACTURED IN LITTLE ROCK, AR

SYMBIOTICA SPECIALITY INGREDIENTS SDN CLOBETASOL PROPIONATE AS MANUFACTURED IN KEDAH, MALAYSIA BHD ALKEM LABORATORIES LTD OLANZAPINE USP (ESUB) AS MANUFACTURED IN A P INDIA FOR ALKEM LABORATORIES LIMITED CALYX CHEMICALS AND PHARMACEUTICALS IRBESARTAN AS MANUFACTURED IN MAHARASHTRA, INDIA LTD MYLAN LABORATORIES LTD CLINDAMYCIN PALMITATE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA YANTAI VALIANT FINE CHEMICAL CO LTD 1, 4-DIOXASPIRO[4.5]DECAN-8-ONE AS MANUFACTURED IN SHANDONG, P.R. CHINA ORCHID CHEMICALS AND PHARMACEUTICALS LTD PRODUCTOS QUIMICOS NATURALES SA DE CV NEULAND LABORATORIES LTD KUKDONG OIL AND CHEMICAL CO LTD UNIQUE CHEMICALS SARONG OLANZAPINE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA DANAZOL AS MANUFACTURED IN IXTACZOQUITLAN, VER., MEXICO MIRTAZAPINE, USP (ANHYDROUS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA WHITE MINERAL OIL LILY-50 AS MANUFACTURED IN KYUNGNAM, KOREA ATENOLOL USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA POLYVINYLCHLORIDE/POLYETHYLENE FILM LAMINATE AS MANUFACTURED IN REGGIOLO (R.E.), ITALY SUMATRIPTAN AS MANUFACTURED IN RUBI (BARCELONA), SPAIN CHOLINE MAGNESIUM TRISALICYLATE POWDER AS MANUFACTURED IN ANDHRA PRADESH, INDIA ARTESUNATE AS MANUFACTURED IN KARNATAKA, INDIA HIGHSTAR PF SERIES AS MANUFACTURED IN HYOGO JAPAN AND HIROSHIMA JAPAN FOR STARPLASTIC INDUSTRY CO LTD RITONAVIR USP AS MANUFACTURED IN MAHARASHTRA INDIA

WARFARIN POTASSIUM ISOPROPANOL SOLVATE AS MANUFACTURED IN ONTARIO CANADA DERIVADOS QUIMICOS SA FINE CHEMICALS FENOFIBRATE AS MANUFACTURED IN MURCIA SPAIN ALP PHARM BEIJING CO LTD CISATRACURIUM BESYLATE AS MANUFACTURED IN SHAANXI PROVINCE CHINA FOR ALP PHARM BEIJING CO LTD

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4Q2012EXCEL DMF# 24035 A 24036 A 24037 24038 A 24039 24040 24041 24042 24043 24044 A 24045 A 24046 A 24047 24048 A 24049 A 24050 24051 24052 24053 24054 A 24055 24056 24057 A 24058 A 24059 A 24060 A 24061 24062 24063 24064 A A P A II III 7/19/2010 7/21/2010 II 8/12/2010 APOTEX PHARMACHEM INDIA PVT LTD *** PENDING FILING REVIEW *** VITAL HEALTH CARE PVT LTD GERRESHEIMER PLASTICOS SAO PAULO LTDA QUININE SULFATE USP AS MANUFACTURED IN GUJARAT, INDIA III 8/5/2010 3M DRUG DELIVERY SYSTEMS III 8/5/2010 3M DRUG DELIVERY SYSTEMS III 8/5/2010 3M DRUG DELIVERY SYSTEMS A A III II III 8/11/2010 8/3/2010 8/5/2010 WINPAK FILMS INC KONDUSKAR LABORATORIES PVT LTD 3M DRUG DELIVERY SYSTEMS PUREFLEX FILM AS MANUFACTURED IN SENOIA, GA A A A P II 11/4/2010 II II II 8/9/2010 8/9/2010 11/4/2010 II 8/2/2010 A II II 8/6/2010 7/8/2010 PARABOLIC DRUGS LTD II 8/2/2010 FERRO PFANSTIEHL III 7/30/2010 FRESENIUS KABI NORGE AS A A N A A III III II 7/31/2010 9/23/2010 8/5/2010 III II 7/16/2010 7/25/2010 A IV II 8/2/2010 7/30/2010 II 7/31/2010 ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD CATALENT PHARMA SOLUTIONS LLC ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD SHAKAI PACKAGING PVT LTD MELODY HEALTHCARE PVT LTD NOT AN ASSIGNED NUMBER MATRI MIRRA PACKAGING PRIVATE LTD AERO PUMP GMBH STATUS Type SUBMIT DATE II 7/26/2010 HOLDER ALP PHARM BEIJING CO LTD SUBJECT

4Q2012

ALVIMOPAN DIHYDRATE AS MANUFACTURED IN CHONGQING CHINA FOR ALP PHARM BEIJING CO LTD QUETIAPINE FUMARATE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA GELATIN MASSES AS MANUFACTURED IN SOMERSET, NJ METOPROLOL TARTRATE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA ALUMINIUM SEALS AS MANUFACTURED IN NANI DAMAN, INDIA SALMETEROL XINAFOATE AS MANUFACTURED IN MAHARASHTRA, INDIA TUBULAR GLASS VIALS USP TYPE-I AS MANUFACTURED IN ANDHRA PRADESH, INDIA METERED DOSE SYSTEMS (ESUB) AS MANUFACTURED IN HOCHHEIM GERMANY

PHARMACEUTICAL WORKS POLPHARMA SA SOLIFENACIN SUCCINATE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND OVALIA POLYPROPYLEN AMPOULES AS MANUFACTURED IN FELUY, BELGIUM FOR FRESENIUS KABI NORGE AS D-RIBOSE, HIGH PURITY (LOW ENDOTOXIN) (R-104-1) AS MANUFATURED IN WAUKEGAN, IL CEFPROZIL USP AS MANUFACTURED IN PUNJAB, INDIA

JOHNSON MATTHEY INC PHARMACEUTICAL AMPHETAMINE SULFATE, USP (PROCESS II) AS MANUFACTURED IN WEST DEPTFORD, NJ MATERIALS GROUP JOHNSON MATTHEY INC PHARMACEUTICAL SODIUM OXYBATE AS MANUFACTURED IN WEST DEPTFORD, NJ MATERIALS GROUP MAHENDRA CHEMICALS LIDOCAINE USP AS MANUFACTURED IN GUJARAT, INDIA MAHENDRA CHEMICALS JUBILANT LIFE SCIENCES LTD *** PENDING FILING REVIEW *** JUBILANT LIFE SCIENCES LTD RIZATRIPTAN BENZOATE (ESUB) AS MANUFACTURED NANJANGUD MYSORE DIST INDIA LIDOCAINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA TELMISARTAN (ESUB) AS MANUFACTURED IN NANJANGUD MYSORE DIST INDIA

LIDOCAINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA 3M SCOTCHPAK(TM) 9753 POLYESTER FILM AS MANUFACTURED IN DECATUR, AL AND GREENVILLE, SC 3M SCOTCHPAK(TM) 9754 POLYESTER FILM AS MANUFACTURED IN DECATUR, AL AND GREENVILLE, SC 3M SCOTCHPAK(TM) 9756 POLYESTER FILM AS MANUFACTURED IN DECATUR, AL AND GREENVILLE, SC 3M SCOTCHPAK(TM) 9757 POLYESTER FILM AS MANUFACTURED IN DECATUR, AL AND GREENVILLE, SC RIZATRIPTAN BENZOATE AS MANUFACTURED IN KARNATAKA, INDIA

DOSAGE CUPS, ORAL SYRINGES, DROPPERS, PIPETTES AND ACCESSORIES FOR PACKAGING AS MANUFACTURED IN EMBU SP, BRASIL

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4Q2012EXCEL DMF# 24065 24066 A 24067 24068 A 24069 A 24070 A 24071 A 24072 A 24073 A 24074 A 24075 24076 24077 24078 24079 A 24080 24081 24082 24083 A 24084 A 24085 A 24086 A 24087 24088 A 24089 A 24090 24091 A C II II 8/23/2010 8/20/2010 MSN PHARMACHEM PVT LTD PHARMATHEN INDUSTRIAL SA III 6/18/2010 WINPAK HEAT SEAL PACKAGING INC A II V 8/18/2010 8/20/2010 II 8/31/2010 II 8/16/2010 II 8/14/2010 A A A II III II II 8/16/2010 8/13/2010 8/17/2010 8/18/2010 3M DRUG DELIVERY SYSTEMS LONSTROFF AG CHEMAGIS LTD TRIAD ISOTOPES INC A A A A III III IV III IV 8/18/2010 8/18/2010 8/18/2010 8/18/2010 8/13/2010 III 8/9/2010 II 6/30/2010 II 8/16/2010 II 8/10/2010 II 9/13/2010 II 1/12/2011 A II III 8/16/2010 9/27/2010 MYLAN LABORATORIES LTD ECLATIN AG STATUS Type SUBMIT DATE A IV II 8/15/2010 8/10/2010 HOLDER CRODA INC SPECTRON MRC LLC SUBJECT CRODALAN AWS AS MANUFACTURED IN MILL HALL, PA

4Q2012

GALLIUM GA68 ALBUMIN AGGREGATED ([68GA]MAA) AS MANUFACTURED IN SOUTH BEND, IN SITAGLIPTIN PHOSPHATE AS MANUFACTURED ANDHRA PRADESH, INDIA

INTERNAL PROTECTIVE LACQUER A-2079 AS MANUFACTURED IN SOLOTHURN, SWITZERLAND ARCH PHARMALABS LTD ATS-8 / (4R-CIS)-1, 1-DIMETHYLETHYL-6-CYANOMETHYL-2,2-DIMETHYL-1,3-DIOXANE-4ACETATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA ARCH PHARMALABS LTD (DKT -III) 4-FLUORO- ALPHA- [2-METHYL-1 -OXO- PROPYL]-Y-OXO-N-BETA- DIPHENYL BENZENE BUTANAMIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA JOHNSON MATTHEY INC PHARMACEUTICAL DEXTROAMPHETAMINE SACCHARATE (PROCESS2) AS MANUFACTURED IN WEST MATERIALS GROUP DEPTFORD, NJ JOHNSON MATTHEY INC PHARMACEUTICAL AMPHETAMINE ASPARTATE (PROCESS2) AS MANUFACTURED IN WEST DEPTFORD, NJ MATERIALS GROUP PIERRE FABRE MEDICAMENT-PLANTES & MILNACIPRAN HYDROCHLORIDE (PROCESS II) AS MANUFACTURED IN CELRA (GIRONA), INDUSTRIE SPAIN FOR PIERRE FABRE MEDICAMENT-PLANTES & INDUSTRIE INGENIA POLYMERS CORP INGENIA POLYMERS IT-982 FILLED WHITE AS MANUFACTURED IN ONTARIO, CANADA, ALBERTA, CANADA AND HOUSTON, TEXAS PPG INDUSTRIES INC PPG9145-403 COATING AS MANUFACTURED IN OAK CREEK, WI AND DELAWARE, OH PPG INDUSTRIES INC FONA INTERNATIONAL INC FABRI PLAST SA AVANTOR PERFORMANCE MATERIALS INC PPG2803-302 COATING AS MANUFACTURED IN OAK CREEK, WI AND DELAWARE, OH 862.0249U N-C LEMON FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL HDPE/BO-TE FAB CONTAINER AS MANFACTURED IN BARCELONA, SPAIN PANEXCEA(TM) MC200G (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA FOR AVANTOR PERFORMANCE MATERIALS INC RESIQUIMOD DRUG SUBSTANCE AS MANUFACTURED IN PITHIVIERS CODEX, FRANCE RUBBER COMPOUNDS AS MANUFACTURED IN AARAU, SWITZERLAND DONEPEZIL HYDROCHLORIDE FORM III AS MANUFACTURED IN BEER SHEVA, ISRAEL

FLUORINE-18 SODIUM FLUORIDE AS MANUFACTURED IN CHARLESTON, SC AND NORCROSS, GA SHANGHAI ZIYUAN PHARMACEUTICAL CO CHLOROTHIAZIDE USP, NON-STERILE, BULK DRUG AS MANUFACTURED IN SHANGHAI, LTD P.R. CHINA BEIJING KEYIFENG BIOTECH DEVELOPMENT ESTRADIOL USP, NON-STERILE, BULK DRUG AS MANUFACTURED IN BEIJING, P.R. CHINA CO LTD AUROBINDO PHARMA LTD RIVASTIGMINE TARTRATE (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA HIKAL LTD QUETIAPINE FUMARATE API AS MANUFACTURED IN BANGALORE, INDIA CARDINAL HEALTH 414 LLC POSITRON EMISSION TOMOGRAPHY (PET) FACILITIES AS LOCATED IN CHARLOTTE, NC; COLTON, CA; COLUMBUS, OH; EAST HARTFORD, CT; FORT LAUDERDALE, FL; ORLANDO, FL; PHOENIX, AZ FLEXIBLE PACKAGING MATERIALS FOR POUCH/SACHET PACKAGING AS MANUFACTURED IN QUEBEC, CANADA ARIPIPRAZOLE [ROUTE CODE: AL1] AS MANUFACTURED IN ANDHRA PRADESH INDIA FLUVASTATIN SODIUM AMORPHOUS AS MANUFACTURED IN GUJARAT, INDIA FOR PHARMATHEN INDUSTRIAL SA

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4Q2012EXCEL DMF# 24092 A 24093 24094 A 24095 A 24096 24097 24098 24099 24100 24101 A 24102 A 24103 A 24104 A 24105 A 24106 24107 A 24108 24109 A 24110 24111 A 24112 A 24113 24114 24115 24116 A 24117 A 24118 A 24119 A II 12/28/2010 II 9/1/2010 ZHEJIANG JINHUA CONBA BIO PHARM CO LTD IPCA LABORATORIES LTD OMEPRAZOLE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA II 11/12/2010 XOMA US LLC A A A III II III II 8/31/2010 8/30/2010 6/21/2010 9/27/2010 HB FULLER CO GULBRANDSEN TECHNOLOGIES INC PLASTIAPE SPA AUROBINDO PHARMA LTD II 8/31/2010 PHARMAZELL DENMARK AS A II IV 8/30/2010 8/25/2010 MACLEODS PHARMACEUTICALS LTD ABELEI INC A II III 8/31/2010 8/20/2010 DAIWA PHARMACEUTICAL CO LTD APTAR FRANCE SAS LOXOPROFEN SODIUM HYDRATE AS MANUFACTURED IN TOYAMA, JAPAN A II II 8/27/2010 8/31/2010 INDOCO REMEDIES LTD DIPHARMA FRANCIS SRL III 7/21/2010 BESPAK DIV CONSORT MEDICAL PLC III 8/24/2010 CONSOLIDATED BOTTLE CORP III 8/24/2010 CONSOLIDATED BOTTLE CORP III 8/24/2010 CONSOLIDATED BOTTLE CORP A A A A A II III II IV II III 8/12/2010 8/24/2010 9/2/2010 8/27/2010 8/26/2010 8/24/2010 CTX LIFE SCIENCES PVT LTD ASSEM PAK INC UNICHEM LABORATORIES LTD SPI PHARMA INC NUTRA SPECIALITIES PRIVATE LTD CONSOLIDATED BOTTLE CORP III 8/2/2010 STELLA KUNSTSTOFFTECHNIK GMBH A II IV 8/17/2010 8/23/2010 3M DRUG DELIVERY SYSTEMS DAVID MICHAEL AND CO INC STATUS Type SUBMIT DATE IV 8/16/2010 HOLDER 3M DRUG DELIVERY SYSTEMS SUBJECT

4Q2012

SOLVATED ACRYLATE COPOLYMER ADHESIVE R-27171 AS MANUFACTURED IN CORDOVA, IL RESIQUIMOD TOPICAL GEL AS MANUFACTURED IN ST. PAUL, MN MICHAELOK NATURAL LEMON FLAVOR #676 AS MANUFACTURED IN PHILADELPHIA, PA STELLA SCREW-NECK BOTTLE SECRO PP28 AND STELLA PROTECAP PP28 AS MANUFACTURED IN SUCY-EN-BRIE, FRANCE AND ELTVILLE, GERMANY FOR STELLA KUNSTSTOFFTECHNIK GMBH CARVEDILOL (ROUTE-II) AS MANUFACTURED IN GUJARAT, INDIA ELASTOMERIC STOPPERS AND CLOSURES AS MANUFACTURED IN VINELAND, NJ ARIPIPRAZOLE (ESUB) AS MANUFACTURED IN ROHA DIST RAIGAD INDIA PHARMABURST 500 AS MANUFACTURED IN GRAND HAVEN, MI TETRACAINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA ? INCH X 2 INCH NATURAL PP VIAL PRINTED WITH LINE AS MANUFACTURED IN ONTARIO, CANADA FOR CONSOLIDATED BOTTLE CORPORATION 1 INCH WHITE SMOOTH TOP PE CAP PLUG FINISH AS MANUFACTURED IN ONTARIO, CANADA FOR CONSOLIDATED BOTTLE CORPORATION 1 INCH X 2 INCH NATURAL PP VIAL PRINTED WITH LINE AS MANUFACTURED IN ONTARIO, CANADA FOR CONSOLIDATED BOTTLE CORPORATION ? INCH WHITE SMOOTH TOP PE CAP PLUG FINISH AS MANUFACTURED IN ONTARIO, CANADA FOR CONSOLIDATED BOTTLE CORPORATION BK357 & BK361 VALVE EXTRACTABLES INFORMATION AS MANUFACTURED IN NORFOLK, ENGLAND OLOPATADINE HYDROCHLORIDE AS MANUFACTURED IN MUMBAI, INDIA GLYCERYL TRINITRATE SOLUTION AS MANUFACTURED IN MERETO DI TOMBA (UD), ITALY

APTAR UNIT DOSE AND BIDOSE SYSTEMS AS MANUFACTURED IN CONGERS, NY AND EIGELTINGEN, GERMANY AND LE VAUDREUIL, FRANCE CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN GUJARAT, INDIA 113a61 NATURAL & ARTIFICIAL BERRY TYPE FLAVOR AS MANUFACTURED IN NORTH AURORA, IL TERBINAFINE AS TERBINAFINE HYDROCHLORIDE AS MANUFACTURED IN HVIDOVRE, DENMARK ADHESIVE USED IN PLASTIC CLOSURE SYSTEMS AS MANUFACTURED IN JACKSON, TN ACHIEVE L 5440 PG SOLUTION AS MANUFACTURED IN PHILLIPSBURG, NJ DESICCANT CAP AND PILL JAR AS MANUFACTURED IN LECCO, ITALY ATORVASTATIN CALCIUM (AMORPHOUS) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA XOMA 3AB (ESUB) AS MANUFACTURED IN BERKELEY CA

ZOLEDRONIC ACID (ESUB) AS MANUFACTURED IN DISTRICT RATLAM (MADHYA PRADESH), INDIA

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4Q2012EXCEL DMF# 24120 24121 A 24122 A 24123 A 24124 24125 24126 24127 24128 A 24129 A 24130 A 24131 A 24132 A 24133 A 24134 A 24135 24136 A 24137 24138 A 24139 24140 A 24141 A 24142 A 24143 I 24144 I 24145 A II 9/23/2010 IV 9/14/2010 IV 9/14/2010 IV 9/14/2010 IV 9/14/2010 KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE USV LIMITED A II III 9/7/2010 6/8/2010 RANBAXY LABORATORIES LTD ROHM AND HAAS CO A III IV 9/3/2010 9/6/2010 RELIANCE INDUSTRIES LTD LIPOID GMBH RELENE 1070LA17 AS MANUFACTURED IN MAHARASHTRA, INDIA A II II 8/16/2010 3/4/2011 VITAL LABORATORIES PVT LTD SHILPA MEDICARE LTD II 8/31/2010 NECTAR LIFESCIENCES LTD II 8/19/2010 QILU PHARMACEUTICAL CO LTD III 8/30/2010 AMPACET CORP III 10/18/2010 II 8/30/2010 ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD HOSPIRA INC II 9/2/2010 TEVA PHARMACEUTICAL INDUSTRIES LTD A A A A II V II II II 9/9/2010 8/25/2010 8/31/2010 9/3/2010 8/31/2010 GLENMARK GENERICS LTD JANSSEN DIAGNOSTICS BVBA SCINOPHARM TAIWAN LTD IRVINE SCIENTIFIC SALES CO RPG LIFE SCIENCES LTD II 9/1/2010 CATALENT PHARMA SOLUTIONS LLC IV 8/30/2010 FERRO PFANSTIEHL STATUS Type SUBMIT DATE A II II 12/9/2010 12/15/2010 HOLDER IPCA LABORATORIES LTD IPCA LABORATORIES LTD SUBJECT

4Q2012

BISOPROLOL FUMARATE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA CITALOPRAM HYDROBROMIDE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA ALPHA, ALPHA-TREHALOSE DIHYDRATE, HIGH PURITY (LOW ENDOTOXIN), USP/NF, EP (T104-4) AS MANUFACTURED IN WAUKEGAN, IL VEGICAPS SOFT SHELL GEL MASS FORMULATION AS MANUFACTURED IN ST. PETERSBURG, FL BOSENTAN (ESUB) AS MANUFACTURED IN GUJARAT INDIA GENOTYPIC RESISTANCE TESTING FOR HCV AS LOCATED IN BEERSE, BELGIUM CAPECITABINE AS MANUFACTURED IN TAINAN COUNTY, TAIWAN, ROC FMDF-11 (KIRIN) AS MANUFACTURED IN SANTA ANA CA DOXORUBICIN HYDROCHLORIDE USP/EP AS MANUFACTURED IN ANKLESHWAR BHARUCH INDIA MYCOPHENOLATE SODIUM AS MANUFACTURED IN DEBRECEN HUNGARY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD CLOPIDOGREL BISULFATE AS MANUFACTURED IN ZHEJIANG CHINA ABBOJECT VIAL INJECTOR (ESUB) AS MANUFACTURED IN ROCKY MOUNT NC 103177 SLIP PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA AND HEATH OH IRINOTECAN HYDROCHLORIDE (NON STERILE, API) AS MANUFACTURED IN SHANDONG PROVINCE PEOPLES REPUBLIC OF CHINA CEFTRIAXONE SODIUM (NON-STERILE) DRUG SUBSTANCE AS MANUFACTURED IN CHANDIGARH INDIA DIGOXIN AS MANUFACTURED IN GUJARAT INDIA GEMCITABINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA

LIPOID E 100, LIPOID E PC S, LIPOID E PC AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY ATORVASTATIN CALCIUM, USP (CRYSTALLINE) AS MANUFACTURED IN PUNJAB, INDIA PARALOID RESINS USED AS A COMPONENT IN PHARMACEUTICAL PACKAGING AS MANUFACTURED IN LOUISVILLE, KY 5X00195 LUBRITOSE SD AS MANUFACTURED IN NORWICH, NY 5X00217 LUBRITOSE MCC AS MANUFACTURED IN NORWICH, NY 5X00255 SHEFFCOAT CLEAR GL AS MANUFACTURED IN NORWICH, NY 5X00282 SHEFFCOAT CLEAR 02 AS MANUFACTURED IN NORWICH, NY DOLASETRON MESYLATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA

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4Q2012EXCEL DMF# 24146 A 24147 24148 C 24149 24150 24151 A 24152 24153 24154 24155 A 24156 A 24157 A 24158 A 24159 24160 A 24161 24162 A 24163 A 24164 A 24165 A 24166 24167 A 24168 A 24169 A 24170 A 24171 24172 A A III III 9/10/2010 9/14/2010 III 9/14/2010 III 9/14/2010 II 9/15/2010 A IV III 9/10/2010 9/14/2010 UNGERER AND CO PPG INDUSTRIES INC PPG PACKAGING AND COATINGS 3D IMAGING DRUG DESIGN AND DEVELOPMENT LLC PPG INDUSTRIES INC PPG PACKAGING AND COATINGS PPG INDUSTRIES INC PPG PACKAGING AND COATINGS HUDSON COLOR CONCENTRATES AMERICAS STYRENICS LLC III 8/19/2010 ALPHAPOINTE ASSN FOR THE BLIND III 8/19/2010 ALPHAPOINTE ASSN FOR THE BLIND II 9/24/2010 A II II 8/29/2010 9/7/2010 A II II 9/1/2010 8/31/2010 TAI HENG INDUSTRY CO LTD CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTD CHEMAGIS LTD DISHMAN PHARMACEUTICALS AND CHEMICALS LTD GLENMARK GENERICS LTD III 3/29/2011 SCHOTT NORTH AMERICA INC II 1/27/2011 MALLINCKRODT INC V 11/24/2010 XOMA US LLC A A A II II II II 8/1/2010 9/10/2010 9/10/2010 9/9/2010 A A IV IV II 8/13/2010 8/13/2010 8/28/2010 DOW CORNING CORP DOW CORNING CORP ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD SERATEC MACLEODS PHARMACEUTICALS LTD INTERQUIM SA ALKALOIDS CORP A II II 7/27/2010 9/9/2010 MICRON TECHNOLOGIES INC TEVA PHARMACEUTICAL INDUSTRIES LTD STATUS Type SUBMIT DATE III 6/23/2010 HOLDER FUJIMORI KOGYO CO LTD SUBJECT

4Q2012

PLASTIC FILMS FOR USE IN DRUG PRODUCT CONTAINER AS MANUFACTURED IN NABARICITY, JAPAN MICRONIZATION PROCESS FACILITY AS LOCATED IN MALVERN, PA SITAGLIPTIN PHOSPHATE AS MANUFACTURED IN ZAGREB, CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD DOW CORNING SILMOGEN CARRIER AS MANUFACTURED IN HEMLOCK, MI DOW CORNING? DIMETHICONOL BLEND 20 AS MANUFACTURED IN HEMLOCK, MI ADEFOVIR DIPIVOXIL DMC (ADVANCE INTERMEDIATE) AS MANUFACTURED IN ZHEJIANG PROVINCE PR CHINA METHYLDOPATE HYDROCHLORIDE USP AS MANUFACTURED IN EURE ET LOIR FRANCE RIVASTIGMINE TARTRATE AS MANUFACTURED IN GUJARAT INDIA SOLIFENACIN SUCCINATE AS MANUFACTURED IN BARCELONA SPAIN COLCHICINE USP (REFINED GRADE) AS MANUFACTURED IN ANDHRA PRADESH INDIA FOR ALKALOIDS CORPORATION NONCLINICAL (PHARMACOLOGY, PHARMACOKINETICS, AND TOXICOLOGY) (ESUB) FOR XOMA 3AB LOCATED IN BERKELEY CA NOSCAPINE USP/EP CRYSTALS CODE 6047 (ESUB) AS MANUFACTURED IN ST LOUIS MO FORMA 3S PREFILLABLE GLASS SYRINGES (ESUB) AS MANUFACTURED IN LEBANON, PA AND QUEENSBURY, NY FOR SCHOTT NORTH AMERICA INC RASAGILINE MESYLATE AS MANUFACTURED IN SHANGHAI PR CHINA CEFTRIAXONE SODIUM (NON-STERILE) AS MANUFACTURED IN HEBEI PROVINCE PR CHINA LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN BEER SHEVA ISRAEL HEXETIDINE AS MANUFACTURED IN GUJARAT INDIA PALIPERIDONE (ESUB) AS MANUFACTURED IN GUJARAT INDIA POLYPROPYLENE PLASTIC BOTTLES USED FOR ORAL MEDICATION AS MANUFACTURED IN KANSAS CITY, MO HIGH DENSITY POLYETHYLENE PLASTIC BOTTLES USED FOR ORAL MEDICATION AS MANUFACTURED IN KANSAS CITY, MO NATURAL MELON WONF FLAVOR #14747 AS MANUFACTURED IN BETHLEHEM, PA PPG4553-603 COATING AS MANUFACTURED IN OAK CREEK, WI AND DELAWARE, OH [F-18] FDPN AS MANUFACTURED IN LITTLE ROCK, ARKANSAS P-2238862 COATING AS MANUFACTURED IN OAK CREEK, WI AND DELAWARE, OH PPG4553-303 COATING AS MANUFACTURED IN OAK CREEK, WI AND DELAWARE, OH WHITE HC81523PVC AS MANUFACTURED IN LEOMINSTER, MA HIGH IMPACT POLYSTYRENE (HIPS) RESINS AS MANUFACTURED IN GALES FERRY, CT; IRONTON, OH; CHANNAHON, IL; TORRANCE, CA AND MARIETTA, OH

Page 738

4Q2012EXCEL DMF# 24173 A 24174 24175 24176 A 24177 II 9/27/2010 A A II II II 8/7/2010 9/13/2010 10/6/2010 SMRUTHI ORGANICS LTD JIANGSU HENGRUI MEDICINE CO LTD STATUS Type SUBMIT DATE II 8/6/2010 HOLDER GLOPEC INTERNATIONAL INC SUBJECT

4Q2012

TEMOZOLOMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR GLOPEC INTERNATIONAL INC S (-) AMLODIPINE BESILATE USP AS MANUFACTURED IN MAHARASHTRA, INDA DOCETAXEL TRIHYDRATE USP AS MANUFACTURED IN JIANGSU, P.R. CHINA

ZHEJIANG XIANJU JUNYE PHARMACEUTICAL NORETHINDRONE (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE PEOPLES CO LTD REPUBLIC OF CHINA UNIMARK REMEDIES LTD RIZATRIPTAN BENZOATE (ESUB) AS MANUFACTURED IN GUJARAT INDIA

A 24178 24179 24180 24181 A 24182 24183 24184 24185 A 24186 24187 A 24188 A 24189 24190 A 24191 A 24192 II 10/6/2010 II 9/16/2010 A II III 9/20/2010 11/9/2010 FORMOSA LABORATORIES INC AERO PUMP GMBH II 9/27/2010 AUROBINDO PHARMA LTD A II IV 9/10/2010 9/16/2010 I A A II II II II 9/15/2010 9/15/2010 9/13/2010 9/17/2010 ELAN DRUG DELIVERY INC DIVIS LABORATORIES LTD POLYDRUG LABORATORIES PVT LTD CHONGQING DAXIN PHARMACEUTICAL CO LTD MEGAFINE PHARMA P LTD HENKEL CORP A A A II II II II 9/13/2010 9/14/2010 9/29/2010 9/15/2010 MACLEODS PHARMACEUTICALS LTD SHASUN PHARMACEUTICALS LTD TORRENT PHARMACEUTICALS LTD MSN ORGANICS PVT LTD VALSARTAN USP AS MANUFACTURED IN GUJARAT, INDIA KETOPROFEN AS MANUFACTURED IN CUDDALORE, INDIA OLMESARTAN MEDOXOMIL (ESUB) AS MANUFACTURED IN GUJARAT INDIA PIOGLITAZONE HYDROCHLORIDE [ROUTE CODE: PG] AS MANUFACTURED IN ANDHRA PRADESH, INDIA N1766 TABLETS AS MANUFACTURED IN KING PRUSSIA, PA TRITYL LOSARTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA FERROUS FUMARATE AS MANUFACTURED IN MAHARASHTRA, INDIA VANCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN CHONGQING, P.R. CHINA SOLIFENACIN SUCCINATE AS MANUFACTURED IN NASHIK, INDIA DURO-TAK(TM) 87-624A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY, NC ENTACAPONE (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA ERGOCALCIFEROL AS MANUFACTURED IN TAOYUAN, TAIWAN

PUMP SYSTEMS FOR ORAL AND TOPIC APPLICATIONS (ESUB) AS MANUFACTURED IN HOCHHEIM GERMANY ESSENTIAL INGREDIENTS CUROXYL BP 42 USP AS MANUFACTURED IN POMPANO BEACH, FL FOR ESSENTIAL INGREDENTS ZHEJIANG XIANJU JUNYE PHARMACEUTICAL ESTRADIOL (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE PEOPLE'S REPUBLIC OF CO LTD CHINA

A 24193 24194 24195 24196 A 24197 A 24198 24199 A A II II 9/21/2010 10/9/2010 ACS DOBFAR SPA SUN PHARMACEUTICAL INDUSTRIES LTD II 9/21/2010 A A A II II II II 9/20/2010 9/20/2010 9/17/2010 9/21/2010 RELIABLE BIOPHARMACEUTICAL CORP KINGLAND CHEMICALS CO LTD CTX LIFE SCIENCES PVT LTD LABORATORIO CHIMICO INTERNAZIONALE SPA NATIONAL JEWISH HEALTH CYANOMETHYL MANNOSYL ACETATE AS MANUFACTURED IN ST. LOUIS, MO BENZONATATE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA CARBAMAZEPINE USP AS MANUFACTURED IN GUJARAT, INDIA PREGABALIN AS MANUFACTURED IN SEGRATE MI, ITALY FBC-0007 (Mn-Te-2PyP) AS MANUFACTURED IN CONCORD, OH FOR NATIONAL JEWISH HEALTH GENTAMICIN SULFATE AS MANUFACTURED IN BERGAMO, ITALY SITAGLIPTIN PHOSPHATE (ESUB) AS MANUFACTURED IN GUJARAT INDIA

Page 739

4Q2012EXCEL DMF# 24200 24201 I 24202 24203 A 24204 24205 24206 24207 24208 24209 A 24210 A 24211 A 24212 A 24213 24214 24215 A 24216 A 24217 A 24218 24219 24220 24221 24222 24223 24224 24225 24226 24227 24228 24229 24230 24231 24232 24233 A A A A A A A A A A A A A A A A III III III III III III III III III III III III III III III III 9/20/2010 9/17/2010 9/20/2010 9/20/2010 9/17/2010 9/20/2010 9/17/2010 9/20/2010 9/21/2010 9/20/2010 9/20/2010 9/20/2010 9/20/2010 9/21/2010 9/20/2010 9/20/2010 CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-LIGHT BLUE PP52176043 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-WHITE PP00176011 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-MID GREY PP72176017 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-BROWN PP83176012 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-RED PP33176028 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-ORANGE PE23176044 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-BLACK PP94176008 AS MANUFACTURED IN MALMO SWEDEN MEVOPUR-BEIGE PE82176048 AS MANUFACTURED IN MALMO SWEDEN III 9/30/2010 II 9/17/2010 A A II III II 9/30/2010 9/27/2010 9/22/2010 IV 9/24/2010 II 9/24/2010 II 9/24/2010 A A A A A III II II II II II 9/23/2010 9/22/2010 9/28/2010 3/4/2011 9/28/2010 10/28/2010 SK CHEMICALS CO LTD INFA SA SMS PHARMACEUTICALS LTD RELIANCE LIFE SCIENCES PVT LTD MYLAN LABORATORIES LTD GLENMARK GENERICS LTD A II II 12/15/2011 8/26/2010 CHEM WERTH INC HAINAN POLY PHARMACEUTICAL CO LTD STATUS Type SUBMIT DATE A II II 10/28/2010 9/25/2010 HOLDER JUBILANT LIFE SCIENCES LTD QILU PHARMACEUTICAL CO LTD SUBJECT

4Q2012

LEVETIRACETAM (ESUB) AS MANUFACTURED IN NANJANGUD MYSORE DIST INDIA CARBOPLATIN PROCESS II AS MANUFACTURED IN SHANDONG PROVINCE PEOPLES REPUBLIC OF CHINA DEXMEDETOMIDINE HCL (ESUB) AS MANUFACTURED IN NEWBURYPORT MA TRIMEBUTINE MALEATE DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA SKYPET BR AS MANUFACTURED IN ULSAN, KOREA MELOXICAM AS MANUFACTURED IN MURCIA, SPAIN FOR INFA S.A. TADALAFIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA IMATINIB MESYLATE (ESUB) AS MANUFACTURED IN NAVI MUMBAI, INDIA LATANOPROST AS MANUFACTURED IN ANDHRA PRADESH, INDIA DEFERASIROX (ESUB) AS MANUFACTURED IN GUJARAT INDIA

JIANGXI SYNERGY PHARMACEUTICAL CO ACECLOFENAC AS MANUFACTURED IN JIANGXI PROVINCE, P.R. CHINA LTD JIANGXI SYNERGY PHARMACEUTICAL CO TELMISARTAN AS MANUFACTURED IN JIANGXI PROVINCE, P.R. CHINA LTD HENRY H OTTENS MANUFACTURING CO INC ARTIFICIAL BUTTERSCOTCH FLAVOR CONCENTRATE #5659 AS MANUFACTURED IN PHILADELPHIA, PA CEDARBURG PHARMACEUTICALS INC BRIMONIDINE TARTRATE AS MANUFACTURED IN GRAFTON, WI FLEXTRUS AB SYMBIOTICA SPECIALITY INGREDIENTS SDN BHD PRODUCTOS QUIMICOS NATURALES SA DE CV PROQUINA BAXTER HEALTHCARE CORP TRANSOFOIL EL-OPET/I AS MANUFACTURED IN LUND, SWEDEN DEXAMETHASONE SODIUM PHOSPHATE AS MANUFACTURED IN KEDAH, MALAYSIA PRASTERONE (DEHYDROEPIANDROSTERONE) AS MANUFACTURED IN IXTACZOQUITLAN VER. MEXICO CLARITY CONTAINER CLOSURE SYSTEM AS MANUFACTURED IN JAYUYA, PUERTO RICO

MEVOPUR-BLUISH GREEN PE63176126 AS MANUFACTURED IN MALMO SWEDEN MEVOPUR-BROWN PE83176049 AS MANUFACTURED IN MALMO SWEDEN MEVOPUR-DARK BLUE PE54176153 AS MANUFACTURED IN MALMO SWEDEN MEVOPUR-DARK BLUE PP54176045 AS MANUFACTURED IN MALMO SWEDEN MEVOPUR-LIGHT BLUE PE52176155 AS MANUFACTURED IN MALMO SWEDEN MEVOPUR-LIGHT GREEN PE62176128 AS MANUFACTURED IN MALMO SWEDEN MEVOPUR-MID BLUE PE52176154 AS MANUFACTURED IN MALMO SWEDEN MEVOPUR-MID BLUE PP52176044 AS MANUFACTURED IN MALMO SWEDEN

Page 740

4Q2012EXCEL DMF# 24234 24235 24236 24237 24238 24239 24240 24241 24242 24243 24244 24245 24246 24247 24248 24249 24250 24251 24252 A 24253 24254 A 24255 A 24256 A 24257 A 24258 24259 24260 24261 24262 24263 24264 24265 24266 A 24267 24268 24269 A A A III III III 9/29/2010 9/29/2010 9/29/2010 CODING PRODUCTS CODING PRODUCTS CODING PRODUCTS A A A A A A A A III III III III III II II IV II 10/1/2010 10/1/2010 10/1/2010 10/1/2010 10/1/2010 10/6/2010 12/2/2010 10/4/2010 10/8/2010 CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB AMINO CHEMICALS LTD APICORE LLC PRODOTTI CHIMICI E ALIMENTARI SPA APOTEX PHARMACHEM INC II 9/15/2010 ALP PHARM BEIJING CO LTD II 9/10/2010 ALP PHARM BEIJING CO LTD II 9/10/2010 A II II 9/24/2010 8/25/2010 GULBRANDSEN TECHNOLOGIES INC LABORATORIO OPOTERAPICO ARGENTINO SA ALP PHARM BEIJING CO LTD STATUS Type SUBMIT DATE A A A A A A A A A A A A A A A A A A III III III III III III III III III III III III III III III III III III III 9/21/2010 9/20/2010 9/20/2010 9/21/2010 9/20/2010 9/20/2010 9/20/2010 9/17/2010 9/20/2010 9/17/2010 9/20/2010 9/20/2010 9/20/2010 9/20/2010 9/20/2010 9/20/2010 9/20/2010 9/17/2010 9/22/2010 HOLDER CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB CLARIANT MASTERBATCHES NORDEN AB HRJ SURGICALS SUBJECT MEVOPUR-MID GREEN PE64176127 AS MANUFACTURED IN MALMO SWEDEN MEVOPUR-MID GREEN PP64176028 AS MANUFACTURED IN MALMO SWEDEN MEVOPUR-RED PE33176131 AS MANUFACTURED IN MALMO SWEDEN MEVOPUR-VIOLET PE43176023 AS MANUFACTURED IN MALMO SWEDEN MEVOPUR-MID GREY PE72176067 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-WHITE PE00176031 AS MANUFACTURED IN MALMO SWEDEN MEVOPUR-YELLOW PE13176076 AS MANUFACTURED IN MALMO SWEDEN MEVOPUR-YELLOW PP13176012 AS MANUFACTURED IN MALMO SWEDEN MEVOPUR-DARK GREY PE74176066 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-PINK PP32176027 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-VIOLET PP43176005 AS MANUFACTURED IN MALMO, SWEDEN

4Q2012

MEVOPUR-BLUISH GREEN PP63176029 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-BEIGE PP82176011 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-BLACK PL94176008 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-DARK GREY PP74176018 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-LIGHT GREEN PP62176027 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-PINK PE32176130 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-ORANGE PP23176008 AS MANUFACTURED IN MALMO, SWEDEN PLASTIC ITEMS USED AS PRIMARY PACKAGING MATERIAL IN PHARMACEUTICAL PRODUCTS AS MANUFACTURED IN MAHARASHTRA, INDIA ACHIEVE L 5440 PG SOLUTION AS MANUFACTURED IN GUJARAT, INDIA CHONDROITIN SULFATE POWDER AS MANUFACTURED IN BUENOS AIRES, ARGENTINA CICLESONIDE AS MANUFACTURED IN TIANJIN, P.R. CHINA FOR ALP PHARM BEIJING CO LTD MESALAMINE AS MANUFACTURED IN HEILONGJIANG, P.R. CHINA FOR ALP PHARM BEIJING CO LTD BIVALIRUDIN AS MANUFACTURED IN ZHEJIANG, P.R. CHINA FOR ALP PHARM BEIJING CO LTD MEVOPUR-TRANS RED PP3M176042 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-TRANS YELLOW PP1M176018 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-TRANS GREY PP7M176029 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-TRANS BLUE PP5M176061 AS MANUFACTURED IN MALMO, SWEDEN MEVOPUR-TRANS GREEN PP6M176048 AS MANUFACTURED IN MALMO, SWEDEN PALIPERIDONE AS MANUFACUTRED IN MARSA, MALTA LENALIDOMIDE (ESUB) AS MANUFACTURED IN SOMERSET NJ GLYCOCHOLIC ACID AS MANUFACTURED IN BASALUZZO (AL), ITALY SITAGLIPTIN PHOSPHATE MONOHYDRATE AS MANUFACTURED IN BRANTFORD ON, CANADA SV-17807 AS MANUFACTURED IN KALKASKA, MI SV-14207 AS MANUFACTURED IN KALKASKA, MI SV-19820 AS MANUFACTURED IN KALKASKA, MI

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4Q2012EXCEL DMF# 24270 24271 A 24272 24273 24274 24275 24276 24277 24278 A 24279 A 24280 A 24281 A 24282 24283 24284 24285 A 24286 A 24287 24288 24289 24290 I 24291 24292 24293 A 24294 A 24295 A 24296 A 24297 A 24298 24299 A A II III 12/17/2010 10/8/2010 IND SWIFT LABORATORIES LTD TEKNOR COLOR CO TEMOZOLOMIDE (ESUB) AS MANUFACTURED IN PUNJAB INDIA II 10/29/2010 IND SWIFT LABORATORIES LTD II 11/4/2010 AUROBINDO PHARMA LTD IV 10/15/2010 ABELEI INC IV 10/15/2010 ABELEI INC A A II II IV 9/28/2010 9/30/2010 10/15/2010 JOHNSON MATTHEY INC ALEMBIC PHARMACEUTICALS LTD ABELEI INC A A A II II II II 12/9/2010 11/1/2010 10/15/2010 10/9/2010 PHF SA USV LIMITED SEQUENT SCIENTIFIC LTD QILU PHARMACEUTICAL CO LTD II 11/8/2010 PHF SA A A A III III III II 9/20/2010 9/20/2010 9/20/2010 10/29/2010 POLYONE CORP POLYONE CORP POLYONE CORP AUROBINDO PHARMA LTD III 9/20/2010 POLYONE CORP III 9/20/2010 POLYONE CORP III 10/7/2010 APTAR FRANCE SAS A N A A I A II II III II II 10/13/2010 12/14/2010 9/20/2010 10/14/2010 10/14/2010 II 10/13/2010 PROTEUS SA NOT AN ASSIGNED NUMBER CADILA HEALTHCARE LTD TARO PHARMACEUTICAL INDUSTRIES LTD HMC POLYMERS CO LTD ALEMBIC PHARMACEUTICALS LTD PHARMAESSENTIA CORP STATUS Type SUBMIT DATE A III III 9/29/2010 8/13/2010 HOLDER CODING PRODUCTS SARONG SUBJECT SV-17383 AS MANUFACTURED IN KALKASKA, MI

4Q2012

EMPTY SUPPOSITORY SHELLS OF POLYVINYLCHLORIDE/POLYETHYLENE FILM LAMINATE AS MANUFACTURED IN REGGIOLO (R.E.), ITALY NEOSAXITOXIN AS MANUFACTURED IN SANTIAGO, CHILE DULOXETINE HYDROCHLORIDE (DUB ROUTE) AS MANUFACTURED IN GUJARAT, INDIA DESLORATADINE (ESUB) AS MANUFACTURED IN HAIFA BAY ISRAEL PURELL RP270M AS MANUFACTURED IN RAYONG, THAILAND FENOFIBRIC ACID AS MAUNFACTURED IN GUJARAT, INDIA GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN TAIPEI HSIENG, TAIWAN FOR PHARMAESSENTIA COROPRATION LATITUDE(TM) SIDE ACTUATION DEVICE AS MANUFACTURED IN LE VAUDREUIL, FRANCE CC10132659BG AS MANUFACTURED IN ASSESSE, BELGIUM AND SAINT-OUEN L'AUMONE, FRANCE CC10132662BG AS MANUFACTURED IN ASSESSE, BELGIUM AND LAINT-OUEN L'AUMONE, FRANCE CC00017726WE AS MANUFACTURED IN ELK GROVE, IL CC00017835WE AS MANUFACTURED IN ELK GROVE, IL CC10012890WE AS MANUFACTURED IN ELK GROVE, IL TRAMADOL HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA LUBIPROSTONE (ESUB) AS MANUFACTURED IN BUENOS AIRES ARGENTINA FOR PHF SA IMATINIB MESYLATE (ESUB) AS MANUFACTURED IN RAICHUR INDIA FOR PHA SA OCTREOTIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA ACYCLOVIR SODIUM AS MANUFACTURED IN KARNATAKA, INDIA RISPERIDONE (NON STERILE, API) AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA MORPHINE TECHNICAL ALKALOID AS MANUFACTURED IN WEST DEPTFORD, NJ PREGABALIN AS MANUFACTURED IN GUJARAT, INDIA 148A84 NATURAL AND ARTIFICIAL GRAPEFRUIT ORANGE FLAVOR AS MANUFACTURED IN NORTH AURORA, IL 196A22 NATURAL AND ARTIFICIAL JUICY FRUIT TYPE FLAVOR AS MANUFACTURED IN NORTH AURORA, IL 174A78 NATURAL AND ARTIFICIAL MINT FLAVOR AS MANUFACTURED IN NORTH AURORA, IL CANDESARTAN CILEXETIL (NON STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA CINACALCET HYDROCHLORIDE (ESUB) AS MANUFACTURED IN PUNJAB INDIA

32,820HCC AMBER 50:1 AS MANUFACTURED IN JACKSONVILLE, TX AND HENDERSON, KY

Page 742

4Q2012EXCEL DMF# 24300 A 24301 A 24302 A 24303 A 24304 A 24305 24306 A 24307 A 24308 A 24309 A 24310 A 24311 A 24312 A 24313 A 24314 24315 24316 A 24317 A 24318 A 24319 A 24320 24321 A 24322 A 24323 A 24324 A II 11/2/2010 UNIMARK REMEDIES LTD II 10/28/2010 TEVA PHARMACEUTICAL INDUSTRIES LTD II 9/15/2010 SAFC BIOSCIENCES INC A IV II 10/27/2010 10/28/2010 SENSIENT PHARMACEUTICAL NAVINTA LLC SPECTRABLEND COATING SYSTEM AS MANUFACTURED IN ST LOUIS MO III 10/19/2010 KJ SPECIALTY PAPER CO LTD III 10/19/2010 KJ SPECIALTY PAPER CO LTD II 9/28/2010 A A II II II 11/8/2010 11/30/2010 10/1/2010 II 10/18/2010 DISHMAN PHARMACEUTICALS AND CHEMICALS LTD PHARMACIA AND UPJOHN SUB PFIZER INC ABBVIE INC YANTAI DONGCHENG BIOCHEMICALS CO LTD KOREA UNITED PHARMACEUTICALS INC II 12/1/2010 ARCH PHARMALABS LTD II 10/22/2010 II 9/17/2010 PRODUCTOS QUIMICOS NATURALES SA DE CV PROQUINA MYLAN LABORATORIES LTD II 10/13/2010 MAPRIMED SA III 10/21/2010 LANXESS DEUTSCHLAND GMBH II 10/19/2010 MSN ORGANICS PVT LTD A II II 10/19/2010 10/13/2010 APOTEX PHARMACHEM INDIA PVT LTD II 10/19/2010 CATALENT PHARMA SOLUTIONS LLC III 10/9/2010 TEKNOR APEX CO III 10/9/2010 TEKNOR APEX CO III 10/9/2010 STATUS Type SUBMIT DATE III 10/7/2010 HOLDER HPT HOCHWERTIGE PHARMATECHNIK GMBH CO KG TEKNOR APEX CO SUBJECT

4Q2012

INJECTION BOTTLES WITH CLINCH NECK FINISH AS MANUFACTURED IN NEUHAUS A. RWG., GERMANY MEDALIST MD-585 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX COMPANY MEDALIST MD-565 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX COMPANY MEDALIST MD-575 NATURAL AS MANUFACTURED IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX COMPANY DUTASTERIDE 0.5 MG SOFT GELATIN CAPSULES AS MANUFACTURED IN ST. PETERSBURG, FL ENTECAVIR AS MANUFACTURED IN BANGALORE KARNATAKA, INDIA

PHARMACEUTICAL WORKS POLPHARMA SA ZOLEDRONIC ACID AS MANUFACTURED IN STAROGARD GDANSKI, POLAND SILDENAFIL CITRATE [ROUTE CODE: SE] AS MANUFACTURED IN ANDHRA PRADESH, INDIA LANXESS BROMOBUTYL 2030 AS MANUFACTURED IN ZWIJNDRECHT, BELGIUM AND SARNIA, ONTARIO, CANADA FLECAINIDE ACETATE PROCESS II (CODE 50856) AS MANUFACTURED IN BUENOS AIRES, ARGENTINA TESTOSTERONE L-2 AS MANUFACTURED IN IXTACZOQUITLAN VER. MEXICO FROVATRIPTAN SUCCINATE MONOHYDRATE AS MANUFACTURED IN MAHARASHTRA, INDIA ATORVASTATIN CALCIUM CRYSTALLINE USP (ATVR) (ESUB) AS MANUFACTURED IN HARYANA INDIA FOR ARCH PHARMALABS LIMITED PANTOPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA TRIAZOLAM USP MICRONIZED (ESUB) AS MANUFACTURED IN KALAMAZOO MI PARICALCITOL DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN SLIGO, IRELAND ENOXAPARIN SODIUM AS MANUFACTURED IN YANTAI DEVELOPMENT ZONE, SHANDONG PROVINCE, P.R. CHINA AZELASTINE HYDROCHLORIDE AS MANUFACTURED IN CHUNGNAM, REPUBLIC OF KOREA DDSF-2 SERIES (DDSF-2, DDSF-2FP AND DDSF-2FPS) BACKING FILMS MADE OF PET FILM AND UNWOVEN CLOTH LAMINATED AS MANUFACTURED IN SHIZUOKA, JAPAN DDSF-151 SERIES (DDSF-151, DDSF-151P AND DDSF-151PS) BACKING FILMS MADE OF PET FILM AND UNWOVEN CLOTH LAMINATED AS MANUFACTURED IN SHIZUOKA, JAPAN

HYDRALAZINE HYDROCHLORIDE USP (P) GRADE AS MANUFACTURED IN GUJARAT INDIA FOR NAVINTA LLC EX-CELL 325 PF CHO SERUM-FREE PROTEIN FREE W/O L-GLUTAMINE AS MANUFACTURED IN DENVER PA PERGOLIDE MESYLATE AS MANUFACTURED IN OPAVA-KOMAROV CZECH REPUBLIC FOR TEVA PHARMACEUTICAL INDUSTRIES LTD MONTELUKAST SODIUM (PROCESS B) (ESUB) AS MANUFACTURED IN GUJARAT INDIA

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4Q2012EXCEL DMF# 24325 A 24326 24327 24328 24329 24330 A 24331 A 24332 I 24333 24334 24335 A 24336 A 24337 24338 A 24339 A 24340 A 24341 24342 A 24343 A 24344 24345 A 24346 24347 A 24348 C 24349 A 24350 24351 24352 A P A II II 11/19/2010 11/9/2010 II 10/20/2010 ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD *** PENDING FILING REVIEW *** GLENMARK GENERICS LTD BEIJING LUNARSUN PHARMACEUTICAL CO LTD II 11/8/2010 HETERO DRUGS LTD A II II 11/5/2010 12/1/2010 SANDOZ PRIVATE LTD WATSON PHARMA PRIVATE LTD POSACONAZOLE AS MANUFACTURED IN MAHARASHTRA INDIA A IV II 10/31/2010 11/4/2010 DOSHION LTD POLACRILEX RESIN (DOSHION P551) AS MANUFACTURED IN GUJARAT INDIA II 12/28/2010 A II III 10/29/2010 10/29/2010 JARI PHARMACEUTICAL CO LTD SHANDONG WEIGAO GROUP MEDICAL POLYMER CO LTD TARO PHARMACEUTICAL INDUSTRIES LTD II 10/30/2010 NECTAR LIFESCIENCES LTD II 3/1/2011 GLAXOSMITHKLINE LLC A II II 11/5/2010 11/12/2010 EXCELLA GMBH GLENMARK GENERICS LTD II 10/21/2010 ALP PHARM BEIJING CO LTD A A II II IV 10/30/2010 4/1/2011 11/1/2010 MACLEODS PHARMACEUTICALS LTD APICORE LLC AARHUSKARLSHAMN SWEDEN AB II 10/8/2010 QILU PHARMACEUTICAL CO LTD II 10/25/2010 ERREGIERRE SPA A A A A II II II III II 10/28/2010 11/1/2010 12/21/2010 10/27/2010 9/10/2010 STATUS Type SUBMIT DATE II 10/25/2010 HOLDER SUBJECT

4Q2012

ZHEJIANG HISUN PHARMACEUTICAL CO LTD ATORVASTATIN CALCIUM AS MANUFACTURED IN ZHEJIANG PROVINCE PEOPLES REPUBLIC OF CHINA MACLEODS PHARMACEUTICALS LTD ESZOPICLONE AS MANUFACTURED IN GUJARAT INDIA SCINOPHARM TAIWAN LTD RPG LIFE SCIENCES LTD FABRI PLAST SA SPECTRON MRC LLC PEMETREXED DISODIUM AS MANUFACTURED IN TAINAN COUNTY TAIWAN ROC CLOPIDOGREL BISULFATE USP (ESUB) AS MANUFACTURED IN MUMBAI INDIA HDPE/BO-CRC FAB CONTAINER AS MANUFACTURED IN BARCELONA SPAIN 3'-DEOXY-3'-[18F]FLUOROTHYMIDINE ([18F]FLT) AS MANUFACTURED IN SOUTH BEND IN PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE PH EUR AS MANUFACTURED IN SAN PAOLO D'ARGON (BG) ITALY ETOPOSIDE (NON-STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE PEOPLES REPUBLIC OF CHINA OLANZAPINE AS MANUFACTURED IN GUJARAT INDIA ZILEUTON USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA FOR APICORE LLC SHEA BUTTERS FOR USE AS EXCIPIENTS IN PHARMACEUTICAL PREPARATIONS LIPEX 102 & LIPEX SHEASOFT AS MANUFACTURED IN KARLSHAMN SWEDEN ADEFOVIR DIPIVOXIL AS MANUFACTURED IN JIANGSU CHINA FOR ALP PHARM BEIJING CO LTD GANCICLOVIR ANHYDROUS R (ESUB) AS MANUFACTURED IN FEUCHT GERMANY ESOMEPRAZOLE MAGNESIUM DIHYDRATE (ESUB) AS MANUFACTURED IN GUJARAT INDIA CEFTAZIDIME (ESUB) AS MANUFACTURED IN CUMBRIA, UK FOR GLAXOSMITHKLINE LLC CEFOTAXIME (NON STERILE DRUG SUBSTANCES INTERMEDIATE) AS MANUFACTURED IN PUNJAB INDIA GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN JIANGSU CHINA ASSEMBLAGES FOR PREFILLED SYRINGES AS MANUFACTURED IN SHANDONG PR CHINA LEVOCETIRIZINE DIHYDROCHLORIDE (ESUB) AS MANUFACTURED IN HAIFA BAY ISRAEL

PHARMACEUTICAL WORKS POLPHARMA SA TOLTERODINE L-TARTRATE AS MANUFACTURED IN STAROGARD GDANSKI POLAND

ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP (ESUB) AS MANUFACTURED IN THANE DISTRICT INDIA ESOMEPRAZOLE MAGNESIUM DIHYDRATE PROCESS II AS MANUFACTURED IN ANDHRA PRADESH INDIA VENLAFAXINE HYDROCHLORIDE API AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA

PALONOSETRON HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT INDIA TEMOZOLOMIDE AS MANUFACTURED IN CHONGQING CHINA FOR BEIJING LUNARSUN PHARMACEUTICAL CO LTD

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4Q2012EXCEL DMF# 24353 24354 A 24355 A 24356 A 24357 A 24358 24359 A 24360 A 24361 II 12/15/2010 JUBILANT LIFE SCIENCES LTD II 11/12/2010 A II II 11/8/2010 11/12/2010 ANHUI WANBEI PHARMACEUTICAL CO LTD HERAEUS PRECIOUS METALS GMBH AND CO KG MUSTAFA NEVZAT ILAC SANAYII AS IV 11/10/2010 II 11/8/2010 LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTD SUHEUNG VIETNAM CO LTD III 11/4/2010 BORMIOLI ROCCO SPA BU PLASTICS STATUS Type SUBMIT DATE A II II 1/10/2011 10/30/2010 HOLDER CAYMAN CHEMICAL CO NECTAR LIFESCIENCES LTD SUBJECT BIMATOPROST DRUG SUBSTANCE AS MANUFACTURED IN ANN ARBOR MI

4Q2012

CEFTRIAXONE SODIUM USP (STERILE) DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB INDIA PET BOTTLE 500 ML - F18048 AS MANUFACTURED IN SAINT SULPICE FRANCE, RIVANAZZANO (PV) ITALY, AND CASTELGUELFO (PR) ITALY ZOLEDRONIC ACID AS MANUFACTURED IN JIANGSU CHINA GELATIN HARD SHELL CAPSULES AS MANUFACTURED IN DONG NAI PROVINCE VIETNAM CLINDAMYCIN PHOSPHATE USP AS MANUFACTURED IN ANHUI PROVINCE CHINA 5-AMINOLEVULINIC ACID HYDROCHLORIDE AS MANUFACTURED IN HANAU, GERMANY STERILE MIXTURE OF AMPICILLIN SODIUM AND SULBACTAM SODIUM (2:1) AS MANUFACTURED IN KUNDL TYROL AUSTRIA, KOCAELI TURKEY AND ISTANBUL TURKEY FOR MUSTAFA NEVZAT ILAC SANAYII AS ENTACAPONE (ESUB) AS MANUFACTURED IN KARNATAKA INDIA

A 24362 24363 24364 24365 24366 A 24367 24368 24369 A 24370 24371 A 24372 A 24373 24374 A 24375 A 24376 A 24377 A II 11/4/2010 ALP PHARM BEIJING CO LTD II 11/1/2010 ALP PHARM BEIJING CO LTD IV 11/15/2010 EASTMAN CHEMICAL CO EASTMAN CELLULOSE ACETATE BUTYRATE (CAB-381-20BP) AS MANUFACTURED IN KINGSPORT TN NELARABINE AS MANUFACTURED IN JILIN PROVINCE CHINA FOR ALP PHARM BEIJING CO LTD VERTEPORFIN AS MANUFACTURED IN JIANGSU PROVINCE CHINA FOR ALP PHARM BEIJING CO LTD A II II 12/1/2010 12/1/2010 II 11/15/2010 CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD UNICHEM LABORATORIES LTD UNICHEM LABORATORIES LTD MYCOPHENOLATE MOFETIL HYDROCHLORIDE ANHYDROUS AS MANUFACTURED IN TAIPEI HSIEN, TAIWAN LACIDIPINE (ESUB) AS MANUFACTURED IN ROHA DIST RAIGAD INDIA TAMSULOSIN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ROHA DIST RAIGAD INDIA A II II 11/9/2010 11/25/2010 A A II II II 11/15/2010 11/12/2010 11/15/2010 A A A A II IV IV III III 11/11/2010 11/12/2010 11/12/2010 11/12/2010 11/8/2010 GLOCHEM INDUSTRIES LTD NUSIL TECHNOLOGY LLC NUSIL TECHNOLOGY LLC LOTTE ALUMINIUM CO LTD RUBY SURGICAL AND ALLIED PRODUCTS PRIVATE LTD HOSPIRA BOULDER INC BASF PHARMA EVIONNAZ SA ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD INTAS PHARMACEUTICALS LTD AUROBINDO PHARMA LTD TELMISARTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA MED50 -5336 AS MANUFACTURED IN CARPINTERIA CA MED-6602 AS MANUFACTURED IN CARPINTERIA CA CONTAINER & CLOSURE AS MANUFACTURED IN GYEONGGI-DO KOREA POLYESTER COILS AS MANUFACTURED IN JALGAON INDIA OXALIPLATIN DRUG SUBSTANCE AS MANUFACTURED IN BOULDER CO ENAMINE AMIDE AS MANUFACTURED IN EVIONNAZ SWITZERLAND N-METHYLPAROXETINE AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA FOR ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD CAPECITABINE USP (ESUB) AS MANUFACTURED IN GUJARAT INDIA MOXIFLOXACIN HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE) (ESUB) ANDHRA PRADESH INDIA

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4Q2012EXCEL DMF# 24378 A 24379 24380 24381 24382 24383 A 24384 24385 24386 24387 A 24388 A 24389 24390 24391 24392 24393 24394 24395 A 24396 24397 24398 24399 24400 24401 24402 24403 24404 A 24405 A 24406 A 24407 24408 A II II 11/17/2010 12/17/2010 OLON SPA PHF SA II 11/30/2010 HETERO DRUGS LTD III 10/29/2010 SARONG A A A A A A A A III II II IV II II II II IV 8/26/2009 11/19/2010 9/9/2010 11/24/2010 11/28/2010 11/10/2010 10/25/2011 11/29/2010 11/29/2010 TREDEGAR FILM PRODUCTS CORP FORMOSA LABORATORIES INC SEPPIC SA VIKRAM THERMO INDIA LTD ASAHI GLASS CO LTD SHANDONG YIBAO BIOLOGICS CO LTD EXCELLA GMBH MYLAN LABORATORIES LTD HENKEL CORP A A A A A A IV IV IV IV II II II 11/22/2010 10/26/2010 10/26/2010 10/26/2010 12/10/2010 3/31/2011 3/31/2011 BASF SE NUSIL TECHNOLOGY LLC NUSIL TECHNOLOGY LLC NUSIL TECHNOLOGY LLC UNICHEM LABORATORIES LTD LUPIN LTD ACS DOBFAR SPA II 11/23/2010 DR REDDYS LABORATORIES LTD A A A IV II II II 8/12/2010 11/30/2010 3/30/2011 11/22/2010 A A A A IV IV II III II 2/22/2011 2/22/2011 11/17/2010 10/29/2010 12/2/2010 BIOSPECTRA BIOSPECTRA MACLEODS PHARMACEUTICALS LTD EZCAP INTERNATIONAL CO LTD SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD SEPPIC SA FRESENIUS KABI ONCOLOGY LTD EXCELLA GMBH INTERQUIM SA UREA AS MANUFACTURED IN STROUDSBURG, PA TROMETHAMINE AS MANUFACTURED IN STROUDSBURG, PA MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA CHILD RESISTANT CLOSURES AS MANUFACTURED IN KYUNGGI DO KOREA RITONAVIR USP AS MANUFACTURED IN SHANGHAI CHINA STATUS Type SUBMIT DATE II 11/5/2010 HOLDER ALP PHARM BEIJING CO LTD SUBJECT

4Q2012

LANREOTIDE AS MANUFACTURED IN SHANGHAI CHINA FOR ALP PHARM BEIJING CO LTD

MONTANOX 80 API AS MANUFACTURED IN CASTRES CEDEX FRANCE FOR SEPPIC SA BUSULFAN (ESUB) AS MANUFACTURED IN WEST BENGAL INDIA MASITINIB MESYLATE (ESUB) AS MANUFACTURED IN FEUCHT GERMANY PALIPERIDONE AS MANUFACTURED IN BARCELONA SPAIN AND ESTADO DE MEXICO (MEXICO) FOR INTERQUIM SA PEMETREXED DISODIUM (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH INDIA KOLLICOAT SMARTSEAL 30 D AS MANUFACTURED IN LUDWIGHAFEN, GERMANY MED-344 (ANTIFOAM 7120) AS MANUFACTURED IN BAKERSFIELD CA MED-346 (ANTIFOAM 70451) AS MANUFACTURED IN BAKERSFIELD CA MED-347 (ANTIFOAM 70454) AS MANUFACTURED IN BAKERSFIELD CA FENOFIBRATE (ESUB) AS MANUFACTURED IN DHAVAT-ROHA DIST RAIGAD INDIA PALIPERIDONE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA CEFEPIME FOR INJECTION (STERILE BULK) (ESUB) AS MANUFACTURED IN MILANO, ITALY CEX-816WR ELASTIC FILM (35621, 35618) AS MANUFACTURED IN LAKE ZURICH IL MYCOPHENOLATE SODIUM AS MANUFACTURED IN TAOYUAN TAIWAN MONTANOX 80 LPI AS MANUFACTURED IN CASTRES CEDEX FRANCE FOR SEPPIC SA METHACRYLIC ACID COPOLYMER TYPE A NF AS MANUFACTURED IN GUJARAT INDIA TAFLUPROST DRUG SUBSTANCE AS MANUFACTURED IN CHIBA JAPAN CHONDROITIN SULFATE SODIUM AS MANUFACTURED IN SHANDONG PROVINCE CHINA LEVOTHYROXINE SODIUM (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA DURO-TAK 87-608A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY NC ALUMINUM/POLYETHYLENE FILM LAMINATE AS MANUFACTURED IN MANDELLO DEL LARIO (LC) ITALY AND BAGNATICA (BERGAMO) ITALY FOR SARONG PANTOPRAZOLE SODIUM SESQUIHYDRATE, USP (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH INDIA TOREMIFENE CITRATE AS MANUFACTURED IN RODANO (MI) ITALY OLOPATADINE HCI USP (ESUB) AS MANUFACTURED IN VICENZA ITALY

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4Q2012EXCEL DMF# 24409 I 24410 24411 A 24412 A 24413 24414 A 24415 24416 24417 A 24418 24419 24420 24421 24422 24423 24424 24425 24426 24427 24428 A 24429 24430 A 24431 A 24432 24433 A 24434 A 24435 A 24436 24437 24438 A A A III II II 12/1/2010 12/10/2010 12/10/2010 HUBENA CO LTD VIRUPAKSHA ORGANICS PVT LTD CHANGZHOU JIAERKE PHARMACEUTICALS GROUP CORP LTD II 12/10/2010 CATALENT PHARMA SOLUTIONS LLC II 12/8/2010 APOTEX PHARMACHEM INC A II II 12/9/2010 12/9/2010 RANBAXY LABORATORIES LTD OCEAN NUTRITION CANADA LTD IV 12/6/2010 I II II 12/8/2010 11/11/2010 RANBAXY LABORATORIES LTD FIDIA FARMACEUTICI SPA DIVISIONE SOLMAG HENKEL CORP A A A A A A A P A A III III III 12/14/2010 11/25/2010 11/29/2010 II II II II II II II 12/2/2010 11/30/2010 12/7/2010 12/7/2010 12/7/2010 1/15/2011 12/13/2010 NOBILUS ENT ALEMBIC PHARMACEUTICALS LTD RANBAXY LABORATORIES LTD DR REDDYS LABORATORIES LTD KREATIVE ORGANICS (P) LTD SUN PHARMACEUTICAL INDUSTRIES LTD SRI KRISHNA PHARMACEUTICALS LTD *** PENDING FILING REVIEW *** CODING PRODUCTS MEDIPHARMAPLAN CO LTD FUJIMORI KOGYO CO LTD TTR-71523 AS MANUFACTURED IN KALKASKA MI CONTAINER & CLOSURE AS MANUFACTURED IN GYEONGGI-DO KOREA N A II IV 3/7/2011 12/1/2010 NOT AN ASSIGNED NUMBER VALDEPHARM MEXICHEM UK LTD NORETHINDRONE (ESUB) AS MANUFACTURED IN VAL DE REUIL, FRANCE A III III 11/18/2010 11/23/2010 ACG PHARMAPACK PVT LTD TEKNOR APEX CO II 12/1/2010 SANDOZ INDUSTRIAL PRODUCTS GMBH A II II 11/30/2010 3/1/2011 STATUS Type SUBMIT DATE II 11/22/2010 HOLDER ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD EMCURE PHARMACEUTICALS LTD GLAXOSMITHKLINE LLC SUBJECT METAXALONE API AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA CIDOFOVIR DIHYDRATE AS MANUFACTURED IN MAHARASHTRA INDIA

4Q2012

CEFUROXIME SODIUM (ESUB) AS MANUFACTURED IN CORK, IRELAND FOR GLAXOSMITHKLINE LLC CEFTRIAXONE SODIUM STERILE AS MANUFACTURED IN FRANKFURT, GERMANY AND KUNDL AUSTRIA FOR SANDOZ INDUSTRIAL PRODUCTS GMBH RIGID PACKAGING FILMS AS MANUFACTURED IN MAHARASHTRA INDIA MEDALIST MD-160A NATURAL AS MANUFACTURED IN SAINT ALBANS VT AND HENDERSON KY FOR TEKNOR APEX COMPANY

BLENDS OF INHALATION GRADE 1, 1, 1, 2, 2, 2, 3-HEPTAFLUOROPROPANE AND INHALATION GRADE 1,1,1,2-TETRAFLUOROETHANE AS MANUFACTURED IN RUNCORN CHESHIRE UNITED KINGDOM DIGOXIN AS MANUFACTURED IN KUTNO POLAND CELECOXIB AS MANUFACTURED IN GUJARAT INDIA TRETINOIN USP (NON STERILE BULK) AS MANUFACTURED IN PUNJAB INDIA ABACAVIR AS MANUFACTURED IN ANDHRA PRADESH INDIA ETODOLAC USP AS MANUFACTURED IN ANDHRA PRADESH INDIA BIVALIRUDIN (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA DOMPERIDONE PH EUR (ESUB) AS MANUFACTURED IN HYDERABAD INDIA

PLASTIC FILMS AND BAG FOR USE IN OUTER PACKAGING OF DRUG PRODUCT AS MANUFACTURED IN MIE PREFECTURE JAPAN TELBIVUDINE AS MANUFACTURED IN PUNJAB INDIA ACITRETIN (FORM I) AS MANUFACTURED IN GARBAGNATE MILANESE (MI) ITALY DURO-TAK 87-6900 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY NC OLMESARTAN MEDOXOMIL AS MANUFACTURED IN PUNJAB INDIA OMEGA-3 ACID ETHYL ESTERS AS MANUFACTURED IN CHARLOTTETOWN PE CANADA FOR OCEAN NUTRITION CANADA LTD VALGANCICLOVIR HYDROCHLORIDE USP AS MANUFACTURED IN KARNATAKA INDIA FOR APOTEX PHARMACHEM INC SOFT GELATIN CAPSULE MANUFACTURING PROCESS FOR OET-10275167 AS MANUFACTURED IN ST PETERSBURG FL GLASS VIALS & GLASS AMPOULES AS MANUFACTURED IN CHOONG NAM-DO KOREA FLUCONAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA PRASTERONE ACETATE AS MANUFACTURED IN JIANGSU CHINA

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4Q2012EXCEL DMF# 24439 A 24440 A 24441 24442 24443 24444 24445 24446 24447 24448 24449 A 24450 24451 24452 24453 24454 24455 A 24456 A 24457 A 24458 A 24459 A 24460 A 24461 A 24462 24463 A 24464 24465 A 24466 A 24467 A 24468 A II 2/24/2011 CONCORD BIOTECH LTD III 11/19/2010 SARONG III 12/20/2010 A IV II 12/17/2010 12/20/2010 ASHA CELLULOSE I PVT LTD JIAOZUO JOINCARE BIOTECHNOLOGICAL CO LTD THE DOW CHEMICAL COMPANY A IV II 12/17/2010 12/17/2010 NUSIL TECHNOLOGY LLC EUTICALS INC II 12/17/2010 CATALENT PHARMA SOLUTIONS LLC V 12/14/2010 IV 12/10/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA BASF SE II 2/2/2011 IV 12/15/2010 IV 12/10/2010 A A A A A II II II II II IV 12/17/2010 12/14/2010 12/15/2010 11/18/2010 12/14/2010 12/10/2010 A A A A A A A A II II II IV II II II II II 12/13/2010 12/13/2010 2/14/2011 12/6/2010 12/13/2010 12/15/2010 12/15/2010 12/15/2010 11/22/2010 IV 12/6/2010 STATUS Type SUBMIT DATE II 12/8/2010 HOLDER SUBJECT

4Q2012

ZHEJIANG HISUN PHARMACEUTICAL CO LTD CAPREOMYCIN SULFATE AS MANUFACTURED IN ZHEJIANG PROVINCE PEOPLES REPUBLIC OF CHINA UNGERER AND CO NATURAL AND ARTIFICIAL YELLOW PLUM LEMON FLAVOR FT-5399 AS MANUFACTURED IN BETHLEHEM PA MYLAN LABORATORIES LTD DIPYRIDAMOLE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA MYLAN LABORATORIES LTD PHF SA DOW CORNING CORP MOREPEN LABORATORIES LTD HETERO DRUGS LTD RANBAXY LABORATORIES LTD RANBAXY LABORATORIES LTD SPECIALTY ENZYMES AND BIOCHEMICALS CO MYLAN LABORATORIES LTD LONZA BRAINE SA MACLEODS PHARMACEUTICALS LTD JIANGSU NHWA PHARMACEUTICAL CO LTD PARABOLIC DRUGS LTD KERRY INGREDIENTS AND FLAVOURS ITALIA SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA GLAXOSMITHKLINE LLC RIVASTIGMINE HYDROGEN TARTRATE AS MANUFACTURED MAHARASHTRA INDIA QUETIAPINE FUMARATE (ESUB) AS MANUFACTURED IN QUEBEC, CANADA FOR PHF SA DOW CORNING ST-DIMETHICONOL 40 AS MANUFACTURED IN HEMLOCK MI MONTELUKAST SODIUM AS MANUFACTURED IN HIMACHAL PRADESH INDIA ATOVAQUONE (FORM-A) AS MANUFACTURED IN ANDHRA PRADESH INDIA SOLIFENACIN SUCCINATE AS MANUFACTURED IN PUNJAB INDIA PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN PUNJAB INDIA ALPHA GALATOSIDASE AS MANUFACTURED IN SINNAR (NASHIK) INDIA FOR SPECIALTY ENZYMES AND BIOCHEMICALS CO ZIDOVUDINE USP (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH INDIA SECRETIN DRUG SUBSTANCE AS MANUFACTURED IN BRAINE-L ALLEUD BELGIUM ATORVASTATIN CALCIUM (AMORPHOUS) AS MANUFACTURED IN GUJARAT INDIA FENOFIBRATE AS MANUFACTURED IN JIANGSU CHINA CEFTIZOXIME SODIUM (STERILE) USP AS MANUFACTURED IN PUNJAB INDIA 20.4573.5P PHA VANILLA FLAVOUR AS MANUFACTURED IN MOZZO (BG) ITALY AND TORINO (TO) ITALY 20.4562.4P PHA ORANGE FLAVOUR AS MANUFACTURED IN MOZZO (BG) ITALY AND TORINO (TO) ITALY 58.3478.1P PHA ORANGE FLAVOUR AS MANUFACTURED IN MOZZO (BG) ITALY AND TORINO (TO) ITALY TOPOTECAN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN CORK, IRELAND FOR GLAXOSMITHKLINE LLC 58.4108.UL PHA ORANGE FLAVOUR AS MANUFACTURED IN MOZZO (BG) ITALY AND TORINO (TO) ITALY KOLLICOAT SMARTSEAL 30 D PRE-CLINICAL SAFETY DATA AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY SOFT GELATIN CAPSULE MANUFACTURING PROCESS FORMULA OET-10275188 (ESUB) AS MANUFACTURED IN ST PETERSBURG FL MED-4840 AS MANUFACTURED IN CARPINTERIA CA OMEGA-3 ACID ETHYL ESTERS DRUG SUBSTANCE AS MANUFACTURED IN SPRINGFIELD MO ASHACEL ETHYL CELLULOSE AS MANUFACTURED IN VALSAD INDIA 7-AMINOCEPHALOSPORANIC ACID AS MANUFACTURED IN HENAN PR CHINA ETHYLENE/VINYL ACETATE CO-POLYMER FORMULATIONS AS MANUFACTURED IN ELK GROVE VILLAGE IL AND RINGWOOD IL POLYVINYLCHLORIDE/POLVINYLIDENE CHLORIDE/POLYETHYLENE FILM LAMINATE AS MANUFACTURED IN REGGIOLO (RE) ITALY SIROLIMIUS (ESUB) AS MANUFACTURED IN AHMEDABAD, INDIA

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4Q2012EXCEL DMF# 24469 24470 24471 A 24472 24473 24474 24475 24476 A 24477 A 24478 A 24479 24480 A 24481 24482 24483 A 24484 A 24485 24486 A 24487 A 24488 A 24489 A 24490 A 24491 A 24492 A 24493 A 24494 A 24495 24496 A A II II 12/28/2010 2/21/2011 COVALENT LABORATORIES PRIVATE LTD JUBILANT LIFE SCIENCES LTD III 12/21/2010 III 12/20/2010 IV 12/21/2010 III 12/23/2010 III 12/23/2010 III 12/23/2010 IV 12/22/2010 II 12/23/2010 A II II 12/23/2010 10/12/2010 MYLAN LABORATORIES LTD III 12/22/2010 BESPAK DIV CONSORT MEDICAL PLC A A II II III 12/22/2010 12/17/2010 12/15/2010 A II II 12/21/2010 12/20/2010 GEDEON RICHTER PLC JIANGSU HANSOH PHARMACEUTICAL CO LTD FORMOSA LABORATORIES INC CODING PRODUCTS EASTMAN CHEMICAL CO III 12/21/2010 HOSOKAWA YOKO CO LTD II 10/1/2010 A A A A II III III III II 1/5/2011 12/21/2010 12/21/2010 12/21/2010 12/8/2010 IND SWIFT LABORATORIES LTD PPG PACKAGING AND COATINGS PPG PACKAGING AND COATINGS PPG PACKAGING AND COATINGS SHANDONG XINHUA PHARMACEUTICAL CO LTD VITAL LABORATORIES PVT LTD STATUS Type SUBMIT DATE A P II 2/11/2011 II 12/24/2010 HOLDER USV LIMITED *** PENDING FILING REVIEW *** GLAXOSMITHKLINE SUBJECT ZOLEDRONIC ACID (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA

4Q2012

AMOXICILLIN SODIUM (ESUB) AS MANUFACTURED IN WEST SUSSEX, UNITED KINGDOM FOR GLAXOSMITHKLINE LLC DBA GLAXOSMITHKLINE TELMISARTAN (ESUB) AS MANUFACTURED IN PUNJAB, INDIA PPG5085-301 COATING AS MANUFACTURED IN OAK CREEK WI AND DELAWARE OH PPG5085-302 COATING AS MANUFACTURED IN OAK CREEK WI AND DELAWARE OH PPG5085-304 COATING AS MANUFACTURED IN OAK CREEK WI AND DELAWARE OH MELOXICAM AS MANUFACTURED IN SHANDONG PR CHINA SCOPOLAMINE BUTYL BROMIDE (HYOSCINE BUTYL BROMIDE) AS MANUFACTURED IN GUJARAT INDIA POLYOLEFIN BAGS AND FILM (POLYELITE SERIES) FOR PHARMACEUTICAL CONTAINER USE AS MANUFACTURED IN NAGANO JAPAN FOR HOSOKAWA YOKO CO LTD DIENOGEST AS MANUFACTURED IN DOROG HUNGARY OLANZAPINE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU CHINA ILOPERIDONE AS MANUFACTURED IN TAOYUAN TAIWAN TTR-74808 AS MANUFACTURED IN KALKASKA MI EASTMAN TRITAN COPOLYESTER PRODUCTION AT TENNESSEE EASTMAN DIVISION AS MANUFACTURED IN KINGSPORT TN BK357 AND BK361 VALVE SPECIFIC INFORMATION AS MANUFACTURED IN NORFOLK, ENGLAND RIVASTIGMINE AS MANUFACTURED IN MAHARASHTRA INDIA

SYMBIOTICA SPECIALITY INGREDIENTS SDN BETAMETHASONE DIPROPIONATE AS MANUFACTURED IN KULIM, KEDAH, MALAYSIA BHD CHEMO IBERICA SA LANSOPRAZOLE AS MANUFACTURED IN ZHEJIANG PROVINCE PR OF CHINA FOR CHEMO IBERICA SA 3M DRUG DELIVERY SYSTEMS SOLVATED ACRYLATE COPOLYMER ADHESIVE R-24449 AS MANUFACTURED IN CORDOVA IL FOR 3M DRUG DELIVERY SYSTEMS DIVISION BORMIOLI ROCCO SPA BU PLASTICS OVERTUNING DROPPER 0.65 MM AS MANUFACTURED IN CASTELGUELFO (PR) ITALY, RIVANAZZANO (PV) ITALY, AND SAINT SULPICE FRANCE BORMIOLI ROCCO E FIGLIO SPA BU TAMPER EVIDENT CLOSURE 15 MM AS MANUFACTURED IN CASTELGUELFO (PR) ITALY, PLASTICA RIVANAZZANO (PV) ITALY, AND SAINT SULPICE FRANCE BORMIOLI ROCCO SPA BU PLASTICS LDPE BOTTLE 10 ML AS MANUFACTURED IN CASTELGUELFO (PR) ITALY, RIVANAZZANO (PV) ITALY, AND SAINT SULPICE FRANCE KERRY BIOFUNCTIONAL INGREDIENTS INC DISINTEQUIK MCC 25 AS MANUFACTURED IN ROTHSCHILD WI FOR KERRY DBA KERRY BIO SCIENCE BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIOSCIENCE BRIGHTWOOD PHARMMED CONSUMABLE MULTILAYER FILM (MF518) AS MANUFACTURED IN HUAI ROU COUNTY BEIJING PR CHINA BEIJING LTD AND TONGZHOU INDUSTRY DISTRICT BEIJING PR CHINA SCHOTT KAISHA PVT LTD NEUTRAL GLASS SULPHUR TREATED VIALS AS MANUFACTURED IN NANI DAMAN INDIA CEFUROXIME ACID (ACETONE ROUTE) AS MANUFACTURED IN ANDHRA PRADESH INDIA CLOPIDOGREL BISULFATE USP (ESUB) AS MANUFACTURED IN MYSORE DIST., INDIA

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4Q2012EXCEL DMF# 24497 24498 24499 24500 A 24501 24502 24503 A 24504 A 24505 24506 24507 A 24508 A 24509 24510 24511 24512 A 24513 24514 A 24515 24516 A 24517 24518 A 24519 24520 A 24521 A 24522 24523 A 24524 24525 24526 24527 A A A A II II II II 1/19/2011 12/31/2010 1/5/2011 1/4/2011 A II II 1/4/2011 12/15/2010 CADILA HEALTHCARE LTD DISHMAN PHARMACEUTICALS AND CHEMICALS LTD GLENMARK GENERICS LTD SARV BIO LABS PVT LTD ALEMBIC PHARMACEUTICALS LTD CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTD II 5/20/2011 CHEMWERTH INC A II II 3/22/2011 1/17/2011 A II II 1/3/2011 12/29/2010 CADILA HEALTHCARE LTD ZHEJIANG SANMEN HENGKANG PHARMACEUTICAL CO LTD JUBILANT LIFE SCIENCES LTD AUROBINDO PHARMA LTD CAPECITABINE USP AS MANUFACTURED IN GUJARAT, INDIA AMIODARONE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, CHINA REPAGLINIDE (ESUB) AS MANUFACTURED IN MYSORE DIST., INDIA A III II 12/30/2010 12/31/2010 GOPALDAS VISRAM AND CO LTD DR REDDYS LABORATORIES LTD A II IV 3/31/2011 12/30/2010 LUPIN LTD SENSIENT FLAVORS LLC A A A II II II III 12/30/2010 12/30/2010 12/30/2010 12/28/2010 MYLAN LABORATORIES LTD SCINOPHARM TAIWAN LTD CHANGZHOU PHARMACEUTICAL FACTORY AMPACET CORP II 12/20/2010 BLOOMAGE FREDA BIOPHARM CO LTD A A II II II 12/21/2010 12/29/2010 12/20/2010 MYLAN LABORATORIES LTD NEULAND LABORATORIES LTD BLOOMAGE FREDA BIOPHARM CO LTD II 12/28/2010 MYLAN LABORATORIES LTD A A II II II 3/27/2011 3/27/2011 12/21/2010 JUBILANT LIFE SCIENCES LTD JUBILANT LIFE SCIENCES LTD MYLAN LABORATORIES LTD STATUS Type SUBMIT DATE A A A II II II II 12/23/2010 12/28/2010 12/28/2010 3/1/2011 HOLDER ROLABO OUTSOURCING SL NAVINTA LLC MYLAN LABORATORIES LTD PFIZER INC SUBJECT PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN ZARAGOZA, SPAIN

4Q2012

TAUROLIDINE AS MANUFACTURED IN ANDHRA PRADESH INDIA FOR NAVINTA LLC ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA TESTOSTERONE UNDECANOATE (ESUB) AS MANUFACTURED IN KALAMAZOO, MICHIGAN RIVASTIGMINE TARTRATE (ESUB) AS MANUFACTURED IN MYSORE DIST., INDIA RIVASTIGMINE (ESUB) AS MANUFACTURED IN MYSORE DIST., INDIA DEXLANSOPRAZOLE SESQUIHYDRATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ELETRIPTAN HYDROBROMIDE (PROCESS 1) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA AMBRISENTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA LINEZOLID (FORM-II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA SODIUM HYALURONATE (HA-EP 3.0) AS MANUFACTURED IN SHANDONG PROVINCE, P.R. OF CHINA SODIUM HYALURONATE (HA-EP 1.8) AS MANUFACTURED IN SHANDONG PROVINCE, P.R. OF CHINA SUNITINIB MALATE AS MANUFACTURED IN MAHARASHTRA, INDIA CLADRIBINE AS MANUFACTURED IN TAINAN, TAIWAN EZETIMIBE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA 502997 AS PE MB AS MANUFACTURED IN MESSANCY, BELGIUM AND TELGATE (BG), ITALY FOR AMPACET CORP DIENOGEST (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA NATURAL AND ARTIFICIAL SPRAY DRIED CITRUS TYPE FLAVORS AS MANUFACTURED IN INDIANAPOLIS, INDIANA BOTTLES AS MANUFACTURED IN KUNDAIM, GOA, INDIA MONTELUKAST SODIUM [PROCESS-2] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

NEVIRAPINE ANHYDROUS USP (PROCESS II) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA BROMFENAC SODIUM (SESQUIHYDRATE) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA FOR CHEMWERTH INC DICLOFENAC EPOLAMINE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA BENZOCAINE AS MANUFACTURED IN GUJARAT, INDIA CHOLINE FENOFIBRATE (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA COLCHICINE USP AS MANUFACTURED IN HIMACHAL PRADESH, INDIA METOPROLOL TARTRATE USP AS MANUFACTURED IN GUJARAT, INDIA CEFAZOLIN SODIUM (STERILE) AS MANUFACTURED IN HEBEI PROVINCE, P.R. CHINA

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4Q2012EXCEL DMF# 24528 24529 A 24530 A 24531 A 24532 A 24533 24534 A 24535 A 24536 A 24537 A 24538 24539 24540 A 24541 A 24542 A 24543 24544 A 24545 24546 24547 24548 A 24549 A 24550 A 24551 A 24552 24553 24554 24555 A A A A II II III III 1/15/2011 1/18/2011 12/21/2010 1/10/2011 MACLEODS PHARMACEUTICALS LTD GEDEON RICHTER PLC GERRESHEIMER REGENSBURG GMBH AMPACET CORP III 1/5/2011 BV RUBBERFABRIEK WITTENBURG II 12/23/2010 II 12/22/2010 A A P II 1/4/2011 II II 12/17/2010 1/12/2011 SAFC INC UQUIFA MEXICO SA DE CV *** PENDING FILING REVIEW *** ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD MYLAN LABORATORIES LTD HALOFUGINONE LACTATE AS MANUFACTURED IN MADISON, WI CARISOPRODOL AS MANUFACTURED IN MORELOS, MEXICO A II II 1/7/2011 3/2/2011 NEWCHEM SPA AUROBINDO PHARMA LTD II 1/31/2011 USV LIMITED II 1/7/2011 MOEHS IBERICA SL A A II III II 1/7/2011 12/15/2010 1/7/2011 CADILA HEALTHCARE LTD PAREKHPLAST INDIA PVT LTD MOEHS IBERICA SL II 1/4/2011 III 12/15/2010 III 12/15/2010 P III 12/15/2010 II 1/6/2011 ACTAVIS PHARMA MANUFACTURING PRIVATE LTD *** PENDING FILING REVIEW *** SUZHOU HAISHUN PACKAGING MATERIAL CO LTD SUZHOU HAISHUN PACKAGING MATERIAL CO LTD SUZHOU HAISHUN PACKAGING MATERIAL CO LTD PARABOLIC DRUGS LTD II 1/6/2011 APOTEX PHARMACHEM INDIA PVT LTD II 1/5/2011 DSM NUTRITIONAL PRODUCTS LTD STATUS Type SUBMIT DATE A II II 12/29/2010 12/31/2010 HOLDER FIS FABBRICA ITALIANA SINTETICI SPA QILU TIANHE PHARMACEUTICAL CO LTD SUBJECT ELETRIPTAN HYDROBROMIDE AS MANUFACTURED IN VICENZA, ITALY

4Q2012

CAPECITABINE (NON-STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA PHYTOMENADIONE (VITAMIN K1) AS MANUFACTURED IN SISSELN, SWITZERLAND FOR DSM NUTRITIONAL PRODUCTS LTD DOLASETRON MESYLATE MONOHYDRATE USP AS MANUFACTURED IN KARNATAKA STATE, INDIA ATORVASTATIN CALCIUM AMORPHOUS (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU, INDIA PCTFE/PVC COMPOSITE SHEET FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN SUZHOU, P.R. CHINA ALUMINIUM FOIL FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN SUZHOU, P.R. CHINA POLYAMIDE/ALUMINIUM/PVC COLD-FORMED FOIL FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN SUZHOU, P.R. CHINA CEFUROXIME AXETIL - AMORPHOUS (PROCESS-III) USP AS MANUFACTURED IN PUNJAB, INDIA ESOMEPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA HDPE BOTTLES WITH CAPS AS MANUFACTURED IN MAHARASHTRA, INDIA CHOLINE FENOFIBRATE AS MANUFACTURED IN BARCELONA, SPAIN FOR MOEHS IBERICA SL QUETIAPINE FUMARATE AS MANUFACTURED IN BARCELONA, SPAIN AND SANTANDER, SPAIN FOR MOEHS IBERICA SL OLOPATADINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA TRIAMCINOLONE ACETONIDE MICRONIZED AS MANUFACTURED IN VERONA, ITALY VALSARTAN USP (PROCESS II) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

LEVALBUTEROL L-TARTRATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA TORSEMIDE, USP AS MANUFACTURED IN ZHEJIANG, CHINA ZIDOVUDINE USP (PROCESS III) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR MYLAN LABORATORIES LTD TPE W4509 THERMOPLASTIC ELASTOMER COMPOUND FOR VIAL CAPS & CLOSURES AS MANUFACTURED IN THE NETHERLANDS RIZATRIPTAN BENZOATE AS MANUFACTURED IN GUJARAT, INDIA ESTRADIOL VALERATE AS MANUFACTURED IN BUDAPEST, HUNGARY ALMIRALL INHALER AS MANUFACTURED IN PFREIMD, GERMANY 120919 SILVER PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA, AND HEATH OH

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4Q2012EXCEL DMF# 24556 A 24557 24558 A 24559 24560 24561 A 24562 A 24563 24564 24565 A 24566 A 24567 24568 24569 24570 24571 24572 24573 24574 A 24575 24576 A 24577 A 24578 24579 24580 24581 A 24582 A 24583 A 24584 A II 2/1/2011 PARABOLIC DRUGS LTD II 1/26/2011 II 3/23/2011 A A A II II II V 3/10/2011 1/24/2011 1/12/2011 2/2/2011 NATCO PHARMA LTD MERCK AND CIE HENAN DONGTAI PHARM CO LTD FDA CDER DIV NEUROLOGY PRODUCTS II 3/8/2011 JUBILANT LIFE SCIENCES LTD A III IV 1/20/2011 1/20/2011 A A A A A A P II 2/3/2011 III III III III III III 1/21/2011 1/21/2011 1/21/2011 1/21/2011 1/21/2011 1/21/2011 POLYONE CORP POLYONE CORP POLYONE CORP POLYONE CORP POLYONE CORP POLYONE CORP *** PENDING FILING REVIEW *** ORCHID CHEMICALS AND PHARMACEUTICALS LTD CLARIANT MASTERBATCHES NORDEN AB MANTROSE HAEUSER CO INC PALIPERIDONE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA MEVOPUR-BLUE PP5M176067-ZN AS MANUFACTURED IN MALMO, SWEDEN IV 1/21/2011 NIPRO PATCH CO LTD P A II III 1/19/2011 1/25/2011 *** PENDING FILING REVIEW *** MACLEODS PHARMACEUTICALS LTD SHINTECH INC TELMISARTAN AS MANUFACTURED IN GUJARAT, INDIA II 12/27/2010 MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH A A II II II 1/18/2011 1/19/2011 1/19/2011 EMCURE PHARMACEUTICALS LTD CARDINAL HEALTH 414 LLC SYNTHON BV A II V 1/19/2011 1/10/2011 HETERO DRUGS LTD WEST PHARMACEUTICAL SERVICES INC STATUS Type SUBMIT DATE III 1/10/2011 HOLDER AMPACET CORP SUBJECT 120937 GOLD PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA, AND HEATH OH CELECOXIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA

4Q2012

CRYSTAL ZENITH (CZ) VIAL READY-TO-USE AS MANUFACTURED IN MONTGOMERY PA, SCOTTSDALE AZ, LIONVILLE PA, SAN DIEGO CA, AND SALT LAKE CITY UT FOR WEST PHARMACEUTICAL SERVICES INC OXALIPLATIN USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA SODIUM ACETATE C-11 INJECTION AS MANUFACTURED IN PHOENIX, AZ LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN BLANSKO, CZECH REPUBLIC FOR SYNTHON BV 5-AMINOLEVULINIC ACID HYDROCHLORIDE 30 MG/ML POWDER FOR ORAL SOLUTION AS MANUFACTURED IN DESSAU-ROSSLAU, GERMANY AND WEDEL, GERMANY FOR MEDAC GESELLSCHAFT FUER KLINISCHE SPEZIALPRAEPARATE MBH

POLYVINYL CHLORIDE HOMOPOLYMER RESIN AS MANUFACTURED IN FREEPORT TX, ADDIS LA, AND PLAQUEMINE LA FOR SHINTECH INC A06 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SAITAMA, JAPAN FOR NIPRO PATCH CO LTD EM1001977260 AS MANUFACTURED IN AVON LAKE, OH EM1001977660 AS MANUFACTURED IN AVON LAKE, OH EM1001977360 AS MANUFACTURED IN AVON LAKE, OH EM1001978560 AS MANUFACTURED IN AVON LAKE, OH EM1001978460 AS MANUFACTURED IN AVON LAKE, OH EM1001977460 AS MANUFACTURED IN AVON LAKE, OH

MANTROCEL K-100M AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA FOR MANTROSE HAEUSER CO INC VALACYCLOVIR HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MYSORE DIST., INDIA SORAFENIB TOSYLATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA DOTAP CHLORIDE AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND DICLOFENAC SODIUM AS MANUFACTURED IN HENAN PROVINCE, CHINA

FDA DATA AND REFERENCE MATERIAL: HISTORICAL CONTROL FOR EPILEPSY MONOTHERAPY CLINICAL TRIALS GLAXOSMITHKLINE LLC SALMETEROL XINAFOATE (ESUB) AS MANUFACTURED IN MONTROSE, UK; JURONG, SINGAPORE; WARE, UK; EVREUX, FRANCE FOR GLAXOSMITHKLINE LLC TAIZHOU TAIFA PHARMACEUTICALS CO LTD MEGESTROL ACETATE AS MANUFACTURED IN ZHEJIANG, CHINA CEFUROXIME AXETIL (CRYSTALLINE) PROCESS-III AS MANUFACTURED IN PUNJAB, INDIA

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4Q2012EXCEL DMF# 24585 24586 24587 24588 24589 A 24590 A 24591 24592 A 24593 24594 24595 A 24596 24597 24598 24599 24600 24601 A 24602 A 24603 24604 A 24605 A 24606 A 24607 A 24608 24609 24610 24611 24612 24613 A 24614 24615 A A II II 2/4/2011 5/3/2011 CENTER MOLECULAR RESEARCH LLC APICORE LLC OXYGEN-18 ENRICHED WATER AS MANUFACTURED IN MOSCOW, RUSSIA C A A A P II 10/7/2011 II II II II 2/3/2011 2/3/2011 2/3/2011 2/3/2011 III 1/21/2011 III 1/21/2011 III 1/21/2011 A II II 1/31/2011 1/17/2011 RAKS PHARMA PVT LTD III 1/13/2011 A A A A A II II II II II II 4/19/2011 3/5/2011 1/21/2011 2/1/2011 1/28/2011 1/28/2011 A A II II II 2/1/2011 1/24/2011 1/21/2011 A II II 1/31/2011 1/31/2011 ALCHYMARS ICM SM PRIVATE LTD ZHEJIANG XIANJU PHARMACEUTICAL CO LTD PARABOLIC DRUGS LTD AREVIPHARMA GMBH HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO LTD CTX LIFE SCIENCES PVT LTD IND SWIFT LABORATORIES LTD SIFAVITOR SRL DR REDDYS LABORATORIES LTD DR REDDYS LABORATORIES LTD CHONGQING CARELIFE PHARMACEUTICAL CO LTD COLORS FOR PLASTICS INC RISEDRONATE SODIUM USP AS MANUFACTURED IN TAMILNADU, INDIA MEGESTROL ACETATE USP (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN ZHEJIANG, CHINA CEFUROXIME ACID (PROCESS-III) AS MANUFACTURED IN PUNJAB, INDIA II 1/31/2011 STATUS Type SUBMIT DATE A A A A II II II II II 1/28/2011 2/15/2011 3/1/2011 3/23/2011 2/1/2011 HOLDER SIFAVITOR SRL IND SWIFT LABORATORIES LTD SUN PHARMACEUTICAL INDUSTRIES LTD SUN PHARMACEUTICAL INDUSTRIES LTD APOTEX PHARMACHEM INDIA PVT LTD SUBJECT HALOPERIDOL AS MANUFACTURED IN LODI, ITALY CLOPIDOGREL BISULFATE USP (ESUB) AS MANUFACTURED IN PUNJAB, INDIA SEVELAMER CARBONATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA MONTELUKAST SODIUM (ESUB) AS MANUFACTURED IN GUJARAT, INDIA

4Q2012

RALOXIFENE HYDROCHLORIDE USP AS MANUFACTURED IN KARNATAKA, INDIA FOR APOTEX PHARMACHEM INC PHARMACEUTICAL WORKS POLPHARMA SA TADALAFIL AS MANUFACTURED IN GDANSKI, POLAND

BUPRENORPHINE HYDROCHLORIDE AS MANUFACTURED IN RADEBEUL, GERMANY HEPARIN SODIUM AS MANUFACTURED IN HEBEI PROVINCE, PEOPLE'S REPUBLIC OF CHINA IRBESARTAN USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FEXOFENADINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN PUNJAB, INDIA CLODRONATE DISODIUM TETRAHYDRATE AS MANUFACTURED IN LODI, ITALY LACOSAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA PALIPERIDONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ENTECAVIR HYDRATE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, PEOPLE'S REPUBLIC OF CHINA THERMOPLASTIC RESIN BROWN COLORANT MASTERBATCHES N08554-1, N08554-2, AND N08554-3 AS MANUFACTURED IN ELK GROVE VILLAGE, IL AND SPARTANBURG, SC PANTOPRAZOLE SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

SHANDONG KEYUAN PHARMACEUTICAL CO METFORMIN HYDROCHLORIDE AS MANUFACTURED IN SHANDONG PROVINCE, CHINA LTD BASF SE ULTRADUR B4520 PRO UNCOLORED AS MANUFACTURED IN SCHWARZHEIDE, GERMANY FOR BASF SE BASF SE ULTRAFORM H4320 PRO UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY BASF SE ULTRAFORM N2320 003 PRO UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY HETERO LABS LTD ZIDOVUDINE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA HETERO LABS LTD HETERO LABS LTD SYMBIOTEC PHARMALAB LTD *** PENDING FILING REVIEW *** IPCA LABORATORIES LTD PANTOPRAZOLE SODIUM USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA LAMIVUDINE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA NEVIRAPINE ANHYDROUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA METHYLPREDNISOLONE ACETATE USP AS MANUFACTURED IN INDORE (M.P), INDIA

MAFENIDE ACETATE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC

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4Q2012EXCEL DMF# 24616 A 24617 A 24618 A 24619 24620 A 24621 A 24622 A 24623 A 24624 A 24625 24626 24627 A 24628 A 24629 24630 24631 24632 24633 A 24634 24635 24636 24637 A 24638 24639 A 24640 24641 24642 24643 A 24644 A II 2/16/2011 CADILA HEALTHCARE LTD A A A II II II II 2/16/2011 2/16/2011 2/15/2011 5/6/2011 DR REDDYS LABORATORIES LTD HETERO DRUGS LTD HOVIONE FARMACIENCIA SA ARCH PHARMALABS LTD A II II 3/31/2011 3/11/2011 LUPIN LTD ARCH PHARMALABS LTD A A A IV III II III 2/12/2011 2/7/2011 2/7/2011 2/16/2011 FLAMEL TECHNOLOGIES SRC MEDICAL INC SMRUTHI ORGANICS LTD MITSUI CHEMICALS AMERICA INC A A A A II II II II II 2/11/2011 2/11/2011 2/4/2011 2/14/2011 2/15/2011 II 1/30/2011 QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTD HETERO DRUGS LTD SYMBIOTEC PHARMALAB LTD SYN TECH CHEM AND PHARM CO LTD ALKERMES GAINESVILLE LLC CILAG AG A A II II II 3/18/2011 2/11/2011 1/31/2011 LUPIN LTD NECTAR LIFESCIENCES LTD II 2/8/2011 MSN LABORATORIES LTD III 2/3/2011 AMCOR FLEXIBLES BURGDORF GMBH III 2/4/2011 II 2/8/2011 CHONGQING HUAPONT PHARMACEUTICAL CO LTD BESPAK DIV CONSORT MEDICAL PLC A II IV 6/27/2012 9/8/2010 TARO PHARMACEUTICAL INDUSTRIES LTD TAKASAGO INTERNATIONAL CORP III 2/3/2011 AMPACET CORP IV 1/28/2011 ABELEI INC STATUS Type SUBMIT DATE III 1/28/2011 HOLDER AMPACET CORP SUBJECT

4Q2012

111717-B WHITE PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA; AND HEATH, OH 174A91 NATURAL & ARTIFICIAL COOL MINT FLAVOR AS MANUFACTURED IN NORTH AURORA, IL 163814 SPRING WATER BLUE PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA; AND HEATH, OH NAFTIFINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN HAIFA BAY, ISRAEL TAK-093146 MICRON ARTIFICIAL STRAWBERRY FLAVOR AS MANUFACTURED IN TETERBORO, NJ ACITRETIN AS MANUFACTURED IN SHAANXI PROVINCE, CHINA FOR CHONGQING HUAPONT PHARMACEUTICAL CO LTD BESPAK BK357 & BK361 SHARED VALVE INFORMATION AS MANUFACTURED IN NORFOLK, ENGLAND TTS BACKING FILM M-PETP 12/ION 12/LDPE 40 (SPECIFICATION #178 INCLUDING #SOP13209 AND #SOP79007) AS MANUFACTURED IN BURGDORF, SWITZERLAND OLOPATADINE HYDROCHLORIDE [ROUTE CODE - "OH"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA CLOPIDOGREL BISULFATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA CEFUROXIME SODIUM USP (STERILE) DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA MIFEPRISTONE AS MANUFACTURED IN HEBEI PROVINCE, CHINA RITONAVIR USP (FORM I), PROCESS II AS MANUFACTURED IN ANDHRA PRADESH, INDIA PREDNISOLONE HEMISUCCINATE USP AS MANUFACTURED IN INDORE (M.P), INDIA METAXALONE AS MANUFACTURED IN HSIN-YING, TAIWAN R.O.C. N1714 TABLETS AS MANUFACTURED IN KING OF PRUSSIA, PA NALOXONE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND AND MOLINAZZO DI MONTEGGIO, SWITZERLAND FOR CILAG AG MEDUSA PGLUVE TYPE POLYMER AS MANUFACTURED IN PESSAC, FRANCE VAGINAL APPLICATORS AS MANUFACTURED IN HANOVER, MA CIPROFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA ADMER SE800 AS MANUFACTURED IN CHIBA, JAPAN FOR MITSUI CHEMICALS AMERICA INC TELMISARTAN USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA TTP.HCL / 4,5,6,7-TETRAHYDROTHIENO (3,2-C) PYRIDINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA OMEPRAZOLE [PROCESS-II] AS MANUFACTURED IN ANDHRA PRADESH, INDIA ESOMEPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA SUMATRIPTAN USP AS MANUFACTURED IN LOURES, PORTUGAL IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA OLMESARTAN MEDOXOMIL (ESUB)

DERIVADOS QUIMICOS SA FINE CHEMICALS CICLETANINE HYDROCHLORIDE AS MANUFACTURED IN MURCIA, SPAIN

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4Q2012EXCEL DMF# 24645 A 24646 24647 24648 24649 24650 A 24651 24652 24653 A 24654 24655 24656 24657 24658 A 24659 24660 A 24661 A 24662 I 24663 24664 24665 24666 24667 24668 A 24669 24670 A 24671 24672 24673 A 24674 24675 24676 A 24677 A IV 3/11/2011 AUTHENTIX INC A A III II III 2/11/2011 2/15/2011 2/14/2011 YOUNG JIN CO LTD PHYTON BIOTECH LLC APTAR FRANCE SAS A A II V III 2/25/2011 2/24/2011 2/18/2011 ALEMBIC PHARMACEUTICALS LTD BD DIAGNOSTIC SYSTEMS JAPAN VILENE CO LTD A II II 2/25/2011 2/25/2011 SMS PHARMACEUTICALS LTD SMS PHARMACEUTICALS LTD A A C A A II II II II II II 4/14/2011 4/7/2011 2/23/2011 2/23/2011 2/23/2011 2/24/2011 TARO PHARMACEUTICAL INDUSTRIES LTD SUN PHARMACEUTICAL INDUSTRIES LTD HETERO LABS LTD HETERO LABS LTD HETERO DRUGS LTD SIEGFRIED LTD II 1/29/2011 QILU PHARMACEUTICAL CO LTD II 2/19/2011 A II II 2/18/2011 2/21/2011 ESTEVE QUIMICA SA ZHEJIANG MEDICINE CO LTD XINCHANG PHARMACEUTICAL FACTORY QILU PHARMACEUTICAL CO LTD A A A A II II II II III 2/18/2011 2/21/2011 2/21/2011 2/18/2011 2/18/2011 A A II II II 2/18/2011 2/18/2011 1/27/2011 A A A A II II III II II 11/28/2012 2/18/2011 2/18/2011 2/14/2011 1/24/2011 STATUS Type SUBMIT DATE II 2/15/2011 HOLDER SUBJECT

4Q2012

JINAN JINDA PHARMACEUTICAL CHEMISTRY NITROFURANTOIN MACROCRYSTALS AS MANUFACTURED IN SHANDONG, CHINA CO LTD APICORE LLC PERPHENAZINE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC STERLING SPA IDEMITSU UNITECH CO LTD INKE SA ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD STERLING SRL APTALIS PHARMATECH INC ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD SUVEN LIFE SCIENCES LTD EMCURE PHARMACEUTICALS LTD DR REDDYS LABORATORIES LTD YUNG ZIP CHEMICAL IND CO LTD LAMINADOS FACARLYTE SA DE CV FLUTICASONE FUROATE AS MANUFACTURED IN PERUGIA, ITALY PLALOC M-700 AS MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN ZOLMITRIPTAN AS MANUFACTURED IN BARCELONA, SPAIN RAMIPRIL AS MANUFACTURED IN ZHEJIANG, CHINA ETONOGESTREL AS MANUFACTURED IN PERUGIA, ITALY EUR-1098 AS MANUFACTURED IN VANDALIA, OHIO IRINOTECAN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA LOSARTAN POTASSIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA ESZOPICLONE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ABACAVIR SULPHATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA METOPROLOL SUCCINATE AS MANUFACTURED IN TAIWAN, R.O.C. HEAT ACTIVATED AND ADHESIVE APPLIED PACKAGING MATERIALS AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN TARRAGONA, SPAIN LEVOFLOXACIN DS AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA PALONOSETRON HYDROCHLORIDE (NON STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE, PEOPLE'S REPUBLIC OF CHINA TAZOBACTAM SODIUM (STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE, PEOPLE'S REPUBLIC OF CHINA TERCONAZOLE USP (MICRONIZED) (ESUB) AS MANUFACTURED IN HAIFA BAY, ISRAEL MESALAMINE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA IRBESARTAN (FORM A) PROCESS II AS MANUFACTURED IN ANDHRA PRADESH, INDIA ZOLEDRONIC ACID MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA MONTELUKAST SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA NALOXONE HYDROCHLORIDE DIHYDRATE AS MANUFACTURED IN ZOFINGEN, SWITZERLAND ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA BICALUTAMIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR SMS PHARMACEUTICALS LIMITED OLMESARTAN MEDOXOMIL AS MANUFACTURED IN GUJARAT, INDIA MICROPRO MICROBIAL DETECTION SYSTEM MEDICAL BACKING MATERIALS OF FILM LAMINATED NON-WOVEN AS MANUFACTURED IN SHIGA, JAPAN CONTAINER & CLOSURE AS MANUFACTURED IN KYUNGKI-DO, KOREA DOCETAXEL ANHYDROUS AS MANUFACTURED IN VANCOUVER, CANADA APTAR UNITDOSE POWDER AND BIDOSE POWDER SYSTEMS AS MANUFACTURED IN CONGERS, NY AND EIGELTINGEN, GERMANY; AND LE VAUDREUIL, FRANCE AUTHENTIX SECURITY MARKER AS MANUFACTURED IN ADDISON, TX Page 755

4Q2012EXCEL DMF# 24678 24679 A 24680 A 24681 24682 24683 24684 24685 24686 24687 24688 24689 24690 24691 24692 A 24693 24694 A 24695 A 24696 24697 24698 24699 A 24700 24701 24702 24703 24704 A 24705 24706 24707 24708 A 24709 A 24710 A IV 3/4/2011 FINAR CHEMICALS LTD II 2/20/2011 HEC PHARM CO LTD A A A II II II II 3/29/2011 2/28/2011 12/20/2010 12/20/2010 DR REDDYS LABORATORIES EU LTD TOMITA PHARMACEUTICAL CO LTD TOMITA PHARMACEUTICAL CO LTD TOMITA PHARMACEUTICAL CO LTD A A P A II III 5/12/2011 3/3/2011 II II 3/3/2011 3/1/2011 SRINI PHARMACEUTICALS LTD WANBURY LTD *** PENDING FILING REVIEW *** COSMA SPA APTAR RADOLFZELL GMBH TELMISARTAN (ESUB) AS MANUFACTURED IN BERGAMO, ITALY A A A III IV II III 2/28/2011 2/27/2011 3/2/2011 1/17/2011 IV 2/24/2011 A II II 2/28/2011 2/25/2011 ESTEVE QUIMICA SA A A A A A A A A A A A II IV III II II II II II II II II II 2/25/2011 2/25/2011 2/28/2011 11/30/2010 3/17/2011 11/26/2010 11/26/2010 11/26/2010 3/24/2011 5/11/2011 3/2/2011 3/1/2011 EMCURE PHARMACEUTICALS LTD PHOSPHOLIPID GMBH ESSEL PROPACK LTD MICRO LABS LTD INDIA ALKEM LABORATORIES LTD MICRO LABS LTD INDIA MICRO LABS LTD INDIA MICRO LABS LTD INDIA SHILPA MEDICARE LTD SHILPA MEDICARE LTD SYMBIOTEC PHARMALAB LTD FRED HUTCHINSON CANCER RESCTR II 2/23/2011 PCAS STATUS Type SUBMIT DATE A II II 2/22/2011 2/25/2011 HOLDER PARABOLIC DRUGS LTD PARABOLIC DRUGS LTD SUBJECT OXACILLIN SODIUM USP AS MANUFACTURED IN HARYANA, INDIA

4Q2012

CEPHALOTHIN SODIUM (STERILE) BUFFERED (USP) AS MANUFACTURED IN PUNJAB, INDIA MIPRI AS MANUFACTURED IN ARAMON, FRANCE AND VILLENEUVE-LA-GARENNE, FRANCE FOR PCAS FELODIPINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA PHOSAL 53 MCT AS MANUFACTURED IN COLOGNE, GERMANY PLASTIC CAPS AND CLOSURES AS MANUFACTURED IN MAHARASHTRA, INDIA ESCITALOPRAM OXALATE AS MANUFACTURED IN KARNATAKA, INDIA DULOXETINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA CELECOXIB AS MANUFACTURED IN KARNATAKA, INDIA TORSEMIDE USP AS MANUFACTURED IN KARNATAKA, INDIA LOSARTAN POTASSIUM USP AS MANUFACTURED IN KARNATAKA, INDIA CAPECITABINE USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA BICALUTAMIDE USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA DEFLAZACORT MICRONIZED AS MANUFACTURED IN INDORE (M.P.), INDIA MANUFACTURE AND QUALITY CONTROL OF THE BC8-DOTA MONOCLONAL ANTIBODY CONJUGATE (BC8-DOTA) AS MANUFACTURED IN SEATTLE, WA RILUZOLE AS MANUFACTURED IN TARRAGONA, SPAIN

ZHEJIANG CHARIOTEER PHARMACEUTICAL VALACYCLOVIR HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CO LTD CHINA HENRY H OTTENS MANUFACTURING CO INC SPRAY DRIED ARTIFICIAL CARAMEL FLAVOR # S-989 AS MANUFACTURED IN PHILADELPHIA, PA ESSEL PROPACK LTD UNPRINTED AND PRINTED LAMINATES AS MANUFACTURED IN MAHARASHTRA, INDIA SHOWA DENKO KK DR REDDYS LABORATORIES LTD EMA PHARMACEUTICALS ADHERO AS MANUFACTURED IN YAMAGATA PREF., JAPAN FOR SHOWA DENKO KK PALIPERIDONE PALMITATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA PACKAGING MATERIAL FOR 32 MM COMBINATED ALUMINIUM CAP AS MANUFACTURED IN LAILLY EN VAL, FRANCE PREGABALIN AS MANUFACTURED IN CHOUTUPPAL AP, INDIA PENICILLAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

OPHTHALMIC DRUG DELIVERY SYSTEMS AS MANUFACTURED IN RADOLFZELL, GERMANY AND EIGELTINGEN, GERMANY LUBIPROSTONE (ESUB) AS MANUFACTURED IN WEST YORKSHIRE, UNITED KINGDOM USP CALCIUM CHLORIDE DIHYDRATE AS MANUFACTURED IN TOKUSHIMA, JAPAN USP ZINC GLUCONATE AS MANUFACTURED IN TOKUSHIMA, JAPAN USP CALCIUM GLUCONATE, MONOHYDRATE (ORAL DOSAGE FORM) AS MANUFACTURED IN TOKUSHIMA, JAPAN CLARITHROMYCIN, NON-STERILE DRUG SUBSTANCE, BULK FORM AS MANUFACTURED IN HUBEI PROVINCE, P.R. CHINA TERTIARY BUTANOL HIGH PURITY GRADE (HP) AS MANUFACTURED IN GUJARAT, INDIA

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4Q2012EXCEL DMF# 24711 A 24712 24713 A 24714 24715 24716 A 24717 24718 24719 A 24720 24721 24722 24723 A 24724 A 24725 24726 24727 A 24728 24729 A 24730 A 24731 A 24732 A 24733 A 24734 A 24735 A 24736 A 24737 A IV 12/15/2010 IV 12/15/2010 IV 12/15/2010 IV 12/15/2010 IV 12/15/2010 IV 12/15/2010 IV 12/10/2010 IV 12/10/2010 A II IV 2/28/2011 12/10/2010 FIS FABBRICA ITALIANA SINTETICI SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA P A II II 3/1/2011 3/10/2011 II 1/18/2011 A A A II II II II 3/25/2011 4/1/2011 3/8/2011 3/4/2011 TORRENT PHARMACEUTICALS LTD TORRENT PHARMACEUTICALS LTD ALCHYMARS ICM SM PRIVATE LTD A A II II II 3/31/2011 3/21/2011 3/26/2011 A A II II II 3/9/2011 3/31/2011 3/8/2011 A II II 3/9/2011 1/20/2011 ALEMBIC PHARMACEUTICALS LTD NORTH CHINA PHARMACEUTICAL GROUP SEMISYNTECH CO LTD ALEMBIC PHARMACEUTICALS LTD LUPIN LTD HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD GLENMARK GENERICS LTD JUBILANT LIFE SCIENCES LTD JUBILANT LIFE SCIENCES LTD STATUS Type SUBMIT DATE IV 3/7/2011 HOLDER DAVID MICHAEL AND CO INC SUBJECT

4Q2012

MICHAELOK ARTIFICIAL STRAWBERRY FLAVOR #3095 AS MANUFACTURED IN PHILADELPHIA, PA WARFARIN SODIUM AMORPHOUS USP AS MANUFACTURED IN GUJARAT, INDIA AMPICILLIN TRIHYDRATE (NON STERILE, API) AS MANUFACTURED IN HEBEI, P.R. CHINA MEXILETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA RITONAVIR - COPOVIDONE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA MUPIROCIN CALCIUM AS MANUFACTURED IN HANGZHOU, CHINA VORICONAZOLE (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA FAMPRIDINE (ESUB) AS MANUFACTURED IN MYSORE DIST., INDIA CYCLOBENZAPRINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MYSORE DIST., INDIA TELMISARTAN USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA MONTELUKAST SODIUM (ESUB) AS MANUFACTURED IN GUJARAT, INDIA MAFENIDE ACETATE USP AS MANUFACTURED IN TAMILNADU, INDIA

ZHEJIANG HISUN PHARMACEUTICAL CO LTD DAPTOMYCIN AS MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF CHINA FOR ZHEJIANG HISUN PHARMACEUTICAL CO., LTD. TEVA PHARMACEUTICAL INDUSTRIES LTD VALSARTAN AS MANUFACTURED IN UTTAR PRADESH, INDIA AND MADHYA PRADESH, INDIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD. *** PENDING FILING REVIEW *** VITAL LABORATORIES PVT LTD 3M DRUG DELIVERY SYSTEMS COLCHICINE USP AS MANUFACTURED IN GUJARAT, INDIA BA058-SOLID MICROSTRUCTURED TRANSDERMAL SYSTEM (BA058-SMTS) COATING AND DRYING PROCESS FOR THE FINISHED DRUG PRODUCT AS MANUFACTURED IN ST. PAUL, MN CLOBAZAM AS MANUFACTURED IN VICENZA, ITALY 20.4566.CP PHA STRAWBERRY FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY 58.3964.2P PHA PEPPERMINT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY 20.4554.CP PHA MILK FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY 58.3514.2P PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY 20.4582.2P PHA SOUR CHERRY FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY 20.4568.1G PHA STRAWBERRY FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY 58.4262.2L PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY 20.4570.3P PHA PASSION FRUIT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY 20.4564.2P PHA GRAPE FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY

Page 757

4Q2012EXCEL DMF# 24738 A 24739 A 24740 A 24741 A 24742 A 24743 A 24744 A 24745 A 24746 A 24747 24748 A 24749 24750 24751 A 24752 A 24753 24754 A 24755 24756 24757 24758 24759 A 24760 24761 A 24762 24763 24764 24765 24766 A A A A A II II II II II 3/15/2011 3/15/2011 3/15/2011 3/28/2011 3/28/2011 A II II 3/16/2011 3/7/2011 DSM FINE CHEMICALS AUSTRIA DISHMAN PHARMACEUTICALS AND CHEMICALS LTD AARTI INDUSTRIES LTD AIR LIQUIDE ELECTRONICS US LP MACLEODS PHARMACEUTICALS LTD JUBILANT LIFE SCIENCES LTD IPCA LABORATORIES LTD A A A P IV 3/14/2011 II II II 3/10/2011 3/31/2011 3/15/2011 CHANGZHOU PHARMACEUTICAL FACTORY UNICHEM LABORATORIES LTD SRINI PHARMACEUTICALS LTD *** PENDING FILING REVIEW *** HENKEL CORP A II II 2/28/2011 2/1/2011 II 3/8/2011 ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD MICRO LABS LTD INDIA ALEMBIC PHARMACEUTICALS LTD A A II II II 3/10/2011 3/14/2011 3/10/2011 HENAN LIHUA PHARMACEUTICAL CO LTD INDUSTRIALE CHIMICA SRL MARUHA NICHIRO FOODS INC A II II 3/10/2011 3/10/2011 SINTENOVO SA DE CV NECTAR LIFESCIENCES LTD II 3/11/2011 IV 12/15/2010 IV 12/15/2010 IV 12/15/2010 IV 12/15/2010 IV 12/15/2010 IV 12/15/2010 IV 12/15/2010 STATUS Type SUBMIT DATE IV 12/15/2010 HOLDER KERRY INGREDIENTS AND FLAVOURS ITALIA SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA KERRY INGREDIENTS AND FLAVOURS ITALIA SPA DR REDDYS LABORATORIES LTD SUBJECT

4Q2012

58.3748.UW PHA PEPPERMINT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY 20.4563.UL PHA CHERRY FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY 20.4557.1G PHA MIXED BERRIES FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY 58.3754.1P PHA SPEARMINT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY 20.4561.1P PHA BLACKCURRANT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY 58.3536.1P PHA LIME FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY 20.4579.1P PHA MIXED BERRIES FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY 58.3520.1P PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY ESOMEPRAZOLE MAGNESIUM (AMORPHOUS) [PROCESS-3] AS MANUFACTURED IN ANDHRA PRADESH, INDIA MONTELUKAST SODIUM AS MANUFACTURED IN MORELOS, MEXICO CEFOTAXIME SODIUM USP (STERILE) DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA PREDNISONE AS MANUFACTURED IN HENAN, CHINA BUMETANIDE AS MANUFACTURED IN SARONNO (VARESSE), ITALY SODIUM HYALURONATE FH AND SODIUM HYALURONATE FL AS MANUFACTURED IN TOCHIGI-PREF, JAPAN IRBESARTAN API AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA DORZOLAMIDE HYDROCHLORIDE USP AS MANUFACTURED IN KARNATAKA, INDIA AZITHROMYCIN MONOHYDRATE USP (PROCESS-II) AS MANUFACTURED IN GUJARAT, INDIA ALISKIREN HEMIFUMARATE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA ZOLMITRIPTAN (ESUB) AS MANUFACTURED IN RAIGAD, INDIA LEVETIRACETAM USP AS MANUFACTURED IN HYDERABAD AP, INDIA DURO-TAK 87-6911 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY, NC NEOSTIGMINE METHYLSULFATE AS MANUFACTURED IN LINZ, AUSTRIA QUETIAPINE FUMARATE AS MANUFACTURED IN GUJARAT, INDIA DIFLUNISAL AS MANUFACTURED IN MAHARASHTRA, INDIA NITRIC OXIDE AS MANUFACTURED IN MORRISVILLE, PA TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN GUJARAT, INDIA SOLIFENACIN SUCCINATE (ESUB) AS MANUFACTURED IN MYSORE DIST., INDIA TRAMADOL HYDROCHLORIDE (YT3 PROCESS) (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA

Page 758

4Q2012EXCEL DMF# 24767 A 24768 A 24769 24770 24771 A 24772 A 24773 24774 24775 24776 A 24777 24778 24779 A 24780 A 24781 24782 C 24783 24784 24785 A 24786 24787 24788 24789 A 24790 24791 A 24792 A 24793 A 24794 24795 24796 A A A II II II 3/28/2011 3/24/2011 3/29/2011 EMCURE PHARMACEUTICALS LTD HENAN LIHUA PHARMACEUTICAL CO LTD ALEMBIC PHARMACEUTICALS LTD II 3/15/2011 KYONGBO PHARMACEUTICAL CO LTD III 3/25/2011 3M DRUG DELIVERY SYSTEMS A II II 3/25/2011 3/25/2011 ALEMBIC PHARMACEUTICALS LTD HOVIONE FARMACIENCIA SA A A A III II II II 3/17/2011 3/22/2011 3/18/2011 3/22/2011 ALPHAPET INC PARABOLIC DRUGS LTD FORMOSA LABORATORIES INC RA CHEM PHARMA LTD PREFORMANCE PET 1708CC(A) AS MANUFACTURED IN DECATUR, AL CEFTAZIDIME FOR INJECTION (USP) AS MANUFACTURED IN PUNJAB, INDIA LAPATINIB DITOSYLATE AS MANUFACTURED IN TAOYUAN, TAIWAN 2-(2,3-DICHLOROPHENYL) METHYLENE HYDRAZINE CARBOXIMID AMIDINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA LINEZOLID AS MANUFACTURED IN GUJARAT, INDIA A A III II IV 3/22/2011 3/23/2011 1/6/2011 TOYO INK MFG CO LTD EMCURE PHARMACEUTICALS LTD SYMRISE AG A II II 6/23/2011 3/23/2011 WOCKHARDT LTD TEVA PHARMACEUTICALS INDUSTRIES LTD IV 3/18/2011 NIPPON FINE CHEMICAL CO LTD A A II II III 3/19/2011 3/22/2011 3/22/2011 EMCURE PHARMACEUTICALS LTD HETERO DRUGS LTD DOW CHEMICAL CO A A A III III II III 3/10/2011 3/10/2011 3/16/2011 3/8/2011 FUTURISTIC PACKAGING PRIVATE LTD FUTURISTIC PACKAGING PRIVATE LTD SMRUTHI ORGANICS LTD NEX PERFORMANCE FILMS V 1/31/2011 ROTEM INDUSTRIES LTD A A II II III 6/27/2012 3/17/2011 3/10/2011 IPCA LABORATORIES LTD HETERO LABS LTD AVI GLOBAL PLAST PVT LTD RITALINIC ACID (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA CANDESARTAN CILEXETIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA II 4/26/2011 IPCA LABORATORIES LTD STATUS Type SUBMIT DATE II 4/20/2011 HOLDER IPCA LABORATORIES LTD SUBJECT

4Q2012

CLOPIDOGREL BISULFATE (XC4 PROCESS) (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA FLUCONAZOLE (G3 PROCESS) (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA

CALENDARED RIGID PVC FILM FOR BLISTER PACKAGING AS MANUFACTURED IN DAMAN, INDIA CASSETTE FOR PRODUCTION OF FLUORINE-18 FLUDEOXYGLUCOSE ON THE TRACERLAB MXFDG SYNTHESIS UNIT AS MANUFACTURED BY ROTEM INDUSTRIES LTD. IN MISHOR YAMIN, ISRAEL ALUMINIUM BLISTER FOIL (COATED/PRINTED) AS MANUFACTURED IN GUJARAT, INDIA ALUMINIUM STRIP FOIL (LAMINATED/PRINTED) AS MANUFACTURED IN GUJARAT, INDIA CIPROFLOXACIN USP AS MANUFACTURED IN MAHARASHTRA, INDIA NEX 1506 MONOLAYER POLYETHYLENE SHEETING FILM AS MANUFACTURED IN TURNERS FALLS, MA AND MILTON, WI THIAMINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA VINYL ACETATE/VINYL CHLORIDE CO-POLYMER FORMULATIONS AS MANUFACTURED IN ELK GROVE VILLAGE, IL CHOLESTEROL HP AS MANUFACTURED IN HYOGO, JAPAN AND SHIZUOKA, JAPAN FOR NIPPON FINE CHEMICAL CO LTD PRAMIPEXOLE DIHYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA ERGOTAMINE TARTRATE AS MANUFACTURED IN KOMAROV, CZECH REPUBLIC FOR TEVA PHARMACEUTICAL INDUSTRIES LTD ELBIMA Z117 AS MANUFACTURED IN TOKYO, JAPAN PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA 207420 STRAWBERRY FLAVOR #68998 AS MANUFACTURED IN HOLZMINDEN GERMANY

FLUTICASONE PROPIONATE INHALATION GRADE AS MANUFACTURED IN LOURES, PORTUGAL BECLOMETHASONE DIPROPIONATE HFA NASAL AEROSOL VALVE AS MANUFACTURED IN LANCASHIRE, GREAT BRITAIN FOR 3M DRUG DELIVERY SYSTEMS CEFOTAXIME SODIUM, STERILE API AS MANUFACTURED IN CHUNGCHEONG NAM-DO, REP OF KOREA DOLASETRON MESYLATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA PREDNISOLONE AS MANUFACTURED IN HENAN, CHINA WARFARIN SODIUM CLATHRATE USP AS MANUFACTURED IN GUJARAT, INDIA

Page 759

4Q2012EXCEL DMF# 24797 24798 A 24799 A 24800 24801 24802 A 24803 24804 24805 24806 24807 24808 24809 A 24810 24811 24812 24813 A 24814 24815 A 24816 24817 24818 A 24819 A 24820 A 24821 24822 24823 24824 A 24825 24826 A 24827 24828 A A II II 4/5/2011 4/5/2011 A II II 4/12/2011 3/21/2011 GLENMARK GENERICS LTD CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTD MSN LABORATORIES LTD MSN LABORATORIES LTD A A A II II II II 3/31/2011 3/30/2011 3/30/2011 5/31/2011 IV 4/1/2011 KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE DR REDDYS LABORATORIES LTD DR REDDYS LABORATORIES LTD DR REDDYS LABORATORIES LTD NATCO PHARMA LTD II 4/4/2011 MERCK AND CIE A A II II II 3/28/2011 3/31/2011 3/31/2011 PIRAMAL HEALTHCARE LTD DR REDDYS LABORATORIES LTD DR REDDYS LABORATORIES LTD A II II 3/30/2011 4/1/2011 DEVATS INDIA PRIVATE LTD MSN LABORATORIES LTD A A A II II II II 3/28/2011 3/30/2011 4/1/2011 3/31/2011 MACLEODS PHARMACEUTICALS LTD DR REDDYS LABORATORIES LTD RICHTER THEMIS MEDICARE I PVT LTD DR REDDYS LABORATORIES LTD A A A A A A IV IV III III III III IV 3/31/2011 3/31/2011 4/1/2011 4/1/2011 3/29/2011 3/31/2011 3/31/2011 FONA INTERNATIONAL INC FONA INTERNATIONAL INC POLYONE CORP POLYONE CORP AMERICHEM INC REXAM HEALTHCARE OFFRANVILLE SAS JRS PHARMA GMBH AND CO KG 828.078 N-C CITRUS FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL 828.112 N-C CITRUS FLAVOR, NATURAL AS MANUFACTURED IN GENEVA, IL A A II III IV 6/27/2011 3/24/2011 3/31/2011 JUBILANT LIFE SCIENCES LTD CLARIANT MASTERBATCHES NORDEN AB FONA INTERNATIONAL INC II 1/8/2011 SRI VYJAYANTHI LABS PVT LTD STATUS Type SUBMIT DATE A II II 3/29/2011 3/23/2011 HOLDER DIVIS LABORATORIES LTD CHEMAGIS LTD SUBJECT VALSARTAN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

4Q2012

PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN SHANGHAI, CHINA FOR CHEMAGIS LTD 2,3,4,5-BIS-O-(1-METHYLETHYLIDENE)-D-FRUCTOPYRANOSE AS MANUFACTURED IN A.P., INDIA QUETIAPINE FUMARATE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA MEVOPUR-PINK PE3M176130 AS MANUFACTURED IN MALMO, SWEDEN 862.0194U FONATECH LEMON FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL

CC10029299WE AS MANUFACTURED IN GLENDALE, AZ AND ELK GROVE VILLAGE, IL CC10075198BG AS MANUFACTURED IN TOSSIAT, FRANCE FOR POLYONE CORP 61644-CD1 WHITE COLORANT AS MANUFACTURED IN CUYAHOGA FALLS, OH EYE DROPPERS SETS AS MANUFACTURED IN OFFRANVILLE, FRANCE SODIUM STARCH GLYCOLATE, PH. EUR, NF, JP AS MANUFACTURED IN GUJARAT, INDIA FOR JRS PHARMA GMBH & CO. KG CANDESARTAN CILEXETIL AS MANUFACTURED IN GUJARAT, INDIA IMATINIB MESYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FAMOTIDINE AS MANUFACTURED IN GUJARAT, INDIA PANTOPRAZOLE SODIUM USP [PROCESS-2] AS MANUFACTURED IN ANDHRA PRADESH, INDIA NIMORAZOLE AS MANUFACTURED IN MAHARASHTRA, INDIA DEXLANSOPRAZOLE SESQUIHYDRATE [ROUTE CODE: "DP"] AS MANUFACTURED ANDHRA PRADESH, INDIA QUETIAPINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ESLICARBAZEPINE ACETATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA VALGANCICLOVIR HYDROCHLORIDE (CRYSTALLINE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA 1, 2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHLINE (DOPC) AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND SHEFFCOAT COATING SYSTEMS AS MANUFACTURED IN NORWICH, NY NEBIVOLOL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FEBUXOSTAT AS MANUFACTURED IN ANDHRA PRADESH, INDIA BENDAMUSTINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA IBANDRONATE SODIUM MONOHYDRATE (INJECTABLE GRADE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA EZETIMIBE (PROCESS II) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA PENICILLIN G POTASSIUM (NON-STERILE) AS MANUFACTURED IN HEBEI PROVINCE, P.R. CHINA ZILEUTON USP [ROUTE CODE -ZN] AS MANUFACTURED IN ANDHRA PRADESH, INDIA SALMETEROL XINAFOATE [ROUTE CODE - SX] AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 760

4Q2012EXCEL DMF# 24829 24830 24831 A 24832 24833 24834 24835 24836 A 24837 A 24838 24839 A 24840 24841 24842 A 24843 A 24844 24845 24846 A 24847 A 24848 A 24849 24850 A 24851 A 24852 A 24853 A 24854 24855 24856 24857 24858 A A A A A II II II II II 6/14/2011 4/12/2011 4/12/2011 4/7/2011 4/5/2011 DR REDDYS LABORATORIES LTD BACHEM SA SYMED LABS LTD SMRUTHI ORGANICS LTD STERLING BIOTECH LTD IV 2/16/2011 UNGERER AND CO II 5/5/2011 CIPLA LTD IV 2/16/2011 UNGERER AND CO A II IV 5/19/2011 2/16/2011 MITSUBISHI TANABE PHARMA CORP UNGERER AND CO II 9/30/2011 MALLINCKRODT INC II 4/8/2011 ACEBRIGHT INDA PHARMA PRIVATE LTD I P II 9/30/2011 II 4/12/2011 ALEMBIC PHARMACEUTICALS LTD *** PENDING FILING REVIEW *** MALLINCKRODT INC III 4/11/2011 FORMOSA PLASTICS CORP PP DIV A A IV IV IV 4/11/2011 4/11/2011 4/11/2011 A II IV 3/26/2011 4/8/2011 TAI HENG INDUSTRY CO LTD MOLKEREI MEGGLE WASSERBURG GMBH AND CO KG FONA INTERNATIONAL INC FONA INTERNATIONAL INC FONA INTERNATIONAL INC II 3/31/2011 QILU TIANHE PHARMACEUTICAL CO LTD A I A A II II II II III 4/6/2011 4/6/2011 3/28/2011 4/7/2011 3/25/2011 ALEMBIC PHARMACEUTICALS LTD ALEMBIC PHARMACEUTICALS LTD MICRO LABS LTD INDIA MSN PHARMACHEM PVT LTD BESPAK DIV CONSORT MEDICAL PLC STATUS Type SUBMIT DATE A A II II II 3/31/2011 4/5/2011 4/1/2011 HOLDER DR REDDYS LABORATORIES LTD ALEMBIC PHARMACEUTICALS LTD DR REDDYS LABORATORIES LTD SUBJECT

4Q2012

FOSAPREPITANT DIMEGLUMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA RABEPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA VALGANCICLOVIR HYDROCHLORIDE (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ILOPERIDONE AS MANUFACTURED IN GUJARAT, INDIA TOPIRAMATE USP AS MANUFACTURED IN GUJARAT, INDIA IRBESARTAN USP AS MANUFACTURED IN KARNATAKA, INDIA APREPITANT (ROUTE CODE - AP) AS MANUFACTURED IN ANDHRA PRADESH, INDIA BK640 NASAL INTERGRATED DOSE COUNTER AS MANUFACTURED IN NORFOLK, UNITED KINGDOM ZIPRASIDONE HYDROCHLORIDE (NON - STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA IMATINIB MESYLATE AS MANUFACTURED IN SHANGHAI CHINA CAPSULAC 60 INH US AS MANUFACTURED IN WESSERBURG, GERMANY 803.0115U N-C RED APPLE TYPE FLAVOR, NAT AS MANUFACTURED IN GENEVA, IL 825.441 N-C WILD CHERRY FLAVOR, ART AS MANUFACTURED IN GENEVA ILLINOIS 862.0085U N-C LEMONADE FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA ILLINOIS YUNGSOX PROPYLENE RESINS AS MANUFACTURED IN KAOHSIUNG CITY, TAIWAN R.O.C. FOR FORMOSA PLASTICS CORPORATION PP DIVISION, TAIWAN CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN GUJARAT, INDIA HYDROCODONE POLISTIREX FOR SUSPENSION, CODE 7490 AS MANUFACTURED IN ST. LOUIS, MO EFAVIRENZ [DRUG SUBSTANCE (NON-STERILE)] AS MANUFACTURED IN KARNATAKA, INDIA CHLORPHENIRAMINE POLISTIREX FOR SUSPENSION, CODE 7480 AS MANUFACTURED IN ST. LOUIS, MO AVANAFIL (ESUB) AS MANUFACTURED IN YAMAGUCHI, JAPAN NATURAL AND ARTIFICIAL ORANGE FLAVOR FS-10783 AS MANUFACTURED IN BETHLEHEM, PA FOR UNGERER & COMPANY. ARTIFICIAL GRAPE FLAVOR FT - 2968 AS MANUFACTURED IN BETHLEHEM, PA FOR UNGERER & COMPANY TENOFOVIR DISOPROXIL FUMARATE PROCESS B (ESUB) AS MANUFACTURED PUNE (MAHARASHTRA) INDA NATURAL BLUEBERRY WONF FLAVOR FT - 2967 AS MANUFACTURED IN BETHLEHEM, PA FOR UNGERER & Company DOCETAXEL ANHYDROUS (ESUB) AS MANUFACTURED IN ANDHRA PRADESH INDIA TRANDOLAPRIL AS MANUFACTURED IN VIONNAZ, SWITZERLAND PHENTERMINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ENROFLOXACIN USP AS MANUFACTURED IN MAHARASHTRA, INDIA DOXORUBICIN HYDROCHLORIDE(API) AS MANUFACTURED IN GUJARAT, INDIA FOR STERLING BIOTECH LIMITED

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4Q2012EXCEL DMF# 24859 A 24860 A 24861 24862 24863 A 24864 A 24865 24866 24867 24868 24869 A 24870 24871 24872 A 24873 24874 24875 24876 24877 A 24878 A 24879 24880 24881 A 24882 A 24883 24884 24885 A 24886 24887 A 24888 24889 A A V II 4/21/2011 4/26/2011 COOK PHARMICA LLC ERREGIERRE SPA A II II 4/25/2011 4/25/2011 A A II II II 11/21/2011 5/6/2011 4/12/2011 RELIANCE LIFE SCIENCES PVT LTD ALKEM LABORATORIES LTD CHONGQING DI LINK PHARMACEUTICAL CO LTD HETERO LABS LTD ANQUI LUAN PHARMACEUTICAL CO LTD II 7/18/2011 AMI ORGANICS PVT LTD A A II II II 4/21/2011 7/29/2011 4/22/2011 FDC LTD RELIANCE LIFE SCIENCES PVT LTD MEGAFINE PHARMA P LTD III 4/20/2011 RPC FORMATIC GMBH A A A A II II II II II 4/18/2011 4/15/2011 4/15/2011 4/15/2011 5/9/2011 HETERO LABS LTD PIRAMAL HEALTHCARE CANADA LTD AMINO CHEMICALS LTD SCI PHARMTECH INC ARCH PHARMALABS LTD A A III II II 4/4/2011 4/18/2011 4/15/2011 FIBERTEX NONWOVENS AS HETERO DRUGS LTD EMCURE PHARMACEUTICALS LTD A A A A III III III II II 4/1/2011 4/1/2011 4/1/2011 5/2/2011 4/15/2011 ADHESIVES RESEARCH INC ADHESIVES RESEARCH INC ADHESIVES RESEARCH INC IPCA LABORATORIES LTD MACLEODS PHARMACEUTICALS LTD II 4/18/2011 AMBIOPHARM INC A A III II II 4/11/2011 7/5/2011 4/6/2011 HOLLAND COLOURS AMERICAS INC APICORE LLC ESTEVE QUIMICA SA V 4/8/2011 BIOLUMIX INC STATUS Type SUBMIT DATE II 4/7/2011 HOLDER STERLING BIOTECH LTD SUBJECT

4Q2012

LOVASTATIN(API) AS MANUFACTURED IN GUJARAT, INDIA FOR STERLING BIOTECH LIMITED MICROBIOLOGICAL RAPID METHOD TO DETECTION AND ENUMERATION OF MICROORGANISMS IN PHARMACEUTICAL PRODUCTS AS LOCATED IN ANN ARBOR, MI COLOR CONCENTRATES FOR PET AS MANUFACTURED IN RICHMOND, IN PENTOSTATIN (ESUB) AS MANUFACTURED IN SOMERSET, NJ ESZOPICLONE AS MANUFACTURED IN BANYERES DEL PENEDES(TARRAGONA), SPAIN FOR ESTEVE QUIMICA, S. A. EPTIFIBATIDE, NON-STERILE, BULK DRUG(API) AS MANUFACTURED IN NORTH AUGUSTA, SC AND SHANGHAI, CHINA FOR AMBIOPHARM INC A4435 (EC-18B ADHESIVE) AS MANUFACTURED IN GLEN ROCK, PA A4436(EC-23B ADHESIVE) AS MANUFACTURED IN GLEN ROCK , PA A4437(MA-80 ADHESIVE) AS MANUFACTURED IN GLEN ROCK, PA ETODOLAC (ED6 PROCESS) (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA ZOLMITRIPTAN AS MANUFACTURED IN GUJARAT, INDIA FOR MACLEODS PHARMACEUTICALS LIMITED FIBERTEX TERCIE 60 AS MANUFACTURED IN SVITAVY,CZECH REPUBLIC SOLIFENACIN SUCCINATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA SEVELAMER HYDROCHLORIDE (PROCESS II) AS MANUFACTURED IN MAHARASHTRA, INDIA FOR EMCURE PHARMACEUTICALS LIMITED VALSARTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA TAZAROTENE AS MANUFACTURED IN ONTARIO, CANADA DEXLANSOPRAZOLE ANHYDROUS AS MANUFACTURED IN MARSA, MALTA ALLOPURINOL AS MANUFACTURED IN TAOYUAN, TAIWAN ATV-1/(4R-CIS)-1, 1-DIMETHYLETHYL 6-{2[2-(4-FLUOROPHENYL)-5-(1-METHYLETHYL)-3PHENYL-4[(PHENYLAMINO) CARBONYL]-1 H-PYRROL-1-YL]ETHYL}-2,2-DIMETHYL-1,3DIOXAN-4-ACETATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA MOUTHPIECE WITH ACTUATION INDICATOR AS MANUFACTURED IN MELLRICHSTADT, GERMANY MICONAZOLE USP AS MANUFACTURED IN MAHARASHTRA STATE, INDIA DUTASTERIDE (ESUB) AS MANUFACTURED IN NAVI MUMBAI, INDIA CINACALCET HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN DIST. NASHIK, INDIA 1-(3-CHLORO PHENYL)-4-(3-CHLOROPROPYL) PIPERAZINE HYDROCHLORIDE AS MANUFACTURED IN GUJURAT, INDIA NANDROLONE DECANOATE USP AS MANUFACTURED IN NAVI MUMBAI, INDIA RIZATRIPTAN BENZOATE (ESUB) AS MANUFACTURED IN GUJARAT INDIA ORLISTAT AS MANUFACTURED IN CHONGQING, CHINA LETROZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ACETAMINOPHEN DC90-3 SD AS MANUFACTURED IN SHANDONG PROVINCE, P. R. OF CHINA STERILE FILLING OPERATION AS LOCATED IN BLOOMINGTON, IN MESALAMINE USP - PH.EUR. (HIGH DENSITY) AS MANUFACTURED IN BERGAMO, ITALY

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4Q2012EXCEL DMF# 24890 24891 A 24892 A 24893 A 24894 24895 24896 A 24897 24898 24899 A 24900 A 24901 24902 A 24903 A 24904 24905 24906 24907 24908 A 24909 A 24910 24911 24912 24913 24914 24915 24916 A 24917 A 24918 24919 24920 A A A II II II 7/30/2011 4/8/2011 4/8/2011 EMCURE PHARMACEUTICALS LTD HUBEI YITAI PHARMACEUTICAL CO LTD HUBEI YITAI PHARMACEUTICAL CO LTD II 5/2/2011 SCI PHARMTECH INC A A A A A A IV III II II II II II 1/12/2011 5/3/2011 2/13/2012 5/25/2011 4/30/2011 5/2/2011 5/4/2011 MINGTAI CHEMICAL CO LTD SABIC EUROPE VALDEPHARM VALDEPHARM CADILA HEALTHCARE LTD POLYDRUG LABORATORIES PVT LTD MSN PHARMACHEM PVT LTD III 4/29/2011 AMPACET CORP A A A A III II II II IV 4/29/2011 5/2/2011 4/18/2011 4/18/2011 4/27/2011 POLYONE CORP SMS PHARMACEUTICALS LTD YONSUNG FINE CHEMICALS CO LTD YONSUNG FINE CHEMICALS CO LTD UNGERER AND CO II 4/29/2011 JIANGSU HENGRUI MEDICINE CO LTD A II II 4/20/2011 8/27/2012 FIS FABBRICA ITALIANA SINTETICI SPA CF PHARMA LTD III 4/25/2011 MEENAKSHI FOILS P A II II 4/29/2011 4/5/2011 A P II 8/16/2011 III 4/28/2011 II 4/26/2011 II 4/18/2011 STATUS Type SUBMIT DATE A II III 4/22/2011 4/25/2011 HOLDER FRESENIUS KABI ANTI INFECTIVES SRL TOPPAN PRINTING CO LTD SUBJECT CEPHAPIRIN SODIUM STERILE AS MANUFACTURED IN VILLADOSE, ITALY

4Q2012

CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTD ZHEJIANG HISUN PHARMACEUTICAL CO LTD GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, PEOPLE'S REPUBLIC OF CHINA HUDSON COLOR CONCENTRATES AMBER HC72646PVC AS MANUFACTURED IN LEOMINSTER, MA *** PENDING FILING REVIEW *** EPHAR BIOLOGICAL AND CHEMICAL CO LTD ATORVASTATIN CALCIUM (API) (ESUB) AS MANUFACTURED IN ANHUI PROVINCE, P.R. CHINA *** PENDING FILING REVIEW *** MSN PHARMACHEM PVT LTD VINDHYA PHARMA INDIA PVT LTD RANOLAZINE[ROUTE CODE: "RL"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA N-METHYL FLUOXETINE OXALATE(NON-STERILE DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA SLITTED & PRINTED FOILS AND SLITTED PVDC COATED PVC FILMS" AS MANUFACTURED IN DAMAN, INDIA ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN VICENZA, ITALY CISATRACURIUM BESYLATE VERSION FA1 AS MANUFACTURED IN BUDAPEST, HUNGARY SEVOFLURANE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU PROVINCE, P. R. CHINA EM1002025410 AS MANUFACTURED IN AVON LAKE, OHIO ELETRIPTAN HYDROBROMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA BIMATOPROST AS MANUFACTURED IN GYEONGGI-DO, KS TRAVOPROST AS MANUFACTURED IN GYCONGGI-DO, REPUBLIC OF KOREA NATURAL AND ARTIFICIAL LEMON LIME FLVP FT-867 AS MANUFACTURED IN BETHLEHEM, PA 101736 AB PE MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER,LA, CARTERSVILLE, GA, HEATH, OH CROSCARMELLOSE SODIUM NF(PROCESS II) AS MANUFACTURED IN TAIWAN, R. O. C. SABIC PP PCGR02 00900 AS MANUFACTURED IN THE NETHERLANDS ETHINYL ESTRADIOL (ESUB) AS MANUFACTURED IN VAL DE REUIL, FRANCE NORETHINDRONE ACETATE (ESUB) AS MANUFACTURED IN VAL DE REUIL, FRANCE PALIPERIDONE API AS MANUFACTURED IN GUJARAT, INDIA LOSARTAN POTASSIUM AS MANUFACTURED IN MAHARASHTRA, INDIA NEBIVOLOL HYDROCHLORIDE[ROUTE CODE: "NH"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA CLINDAMYCIN PALMITATE HYDROCHLORIDE AS MANUFACTURED IN TAOYUAN, TAIWAN ESOMEPRAZOLE SODIUM (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ACYCLOVIR(NON-STERILE,BULK FORM) AS MANUFACTURED IN HUBEI, P. R. CHINA VALACYCLOVIR HYDROCHLORIDE(NON-STERILE, BULK FORM) AS MANUFACTURED IN HUBEI, P. R. CHINA

HP-4, PACKAGE FOR TRANSDERMAL DRUG DELIVERY PATCHES AS MANUFACTURED IN FUKUOKA, JAPAN CEFOTAXIME SODIUM STERILE AS MANUFACTURED IN HEBEI, CHINA

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4Q2012EXCEL DMF# 24921 24922 24923 A 24924 24925 24926 24927 A 24928 24929 24930 A 24931 24932 24933 24934 C 24935 A 24936 24937 24938 24939 A 24940 24941 24942 24943 24944 24945 24946 A 24947 24948 24949 A 24950 24951 A 24952 A 24953 A III 5/16/2011 SAM A ALUMINIUM CO LTD IV 5/12/2011 UNGERER AND CO A III IV 5/26/2011 5/16/2011 SELECTIVE COATINGS AND INKS INC JRS PHARMA GMBH AND CO KG A A II II II 5/18/2011 10/13/2011 11/3/2011 HETERO LABS LTD JUBILANT LIFE SCIENCES LTD APICORE LLC A A A C A A IV II II II II II II 5/16/2011 5/11/2011 5/17/2011 5/17/2011 8/23/2011 6/1/2011 10/20/2011 FONA INTERNATIONAL INC FRESENIUS KABI ANTI INFECTIVES SRL GLOCHEM INDUSTRIES LTD HETERO LABS LTD SHILPA MEDICARE LTD UNIMARK REMEDIES LTD CHEMWERTH INC A A A II II III II 5/12/2011 5/12/2011 1/19/2011 5/6/2011 II 5/10/2011 ZHEJIANG JIANGBEI PHARMACEUTICAL CO LTD ULKAR KIMYA SANAYI VE TICARET AS ULKAR KIMYA SANAYI VE TICARET AS HUAYI ISOTOPES CORP SCI PHARMTECH INC A A A III II II II 4/8/2011 5/10/2011 5/11/2011 5/12/2011 BOREALIS AG SYMED LABS LTD CHEMI SPA TEVA PHARMACEUTICAL INDUSTRIES LTD A A II II III 5/2/2012 5/9/2011 4/8/2011 MALLINCKRODT INC ZACH SYSTEM SPA BOREALIS AG A A A II IV IV II 5/2/2011 5/5/2011 5/4/2011 5/2/2012 STATUS Type SUBMIT DATE A A II II II 5/28/2011 6/8/2011 5/2/2011 HOLDER CONCORD BIOTECH LTD EMCURE PHARMACEUTICALS LTD SHOUGUANG FUKANG PHARMACEUTICAL CO LTD MOEHS IBERICA SL LIPOID GMBH JRS PHARMA GMBH AND CO KG MALLINCKRODT INC SUBJECT TEMSIROLIMUS (ESUB) AS MANUFACTURED IN AHMEDABAD, INDIA BICALUTAMIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA OMEPRAZOLE (C-015) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA RABEPRAZOLE SODIUM AS MANUFACTURED IN RUBI(BARCELONA), SPAIN

4Q2012

LIPOID PG 16:O/16:0 (DPPG-NA) AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY HYPROMELLOSE USP AS MANUFACTURED IN ZACAPU, MEXICO BUPRENORPHINE HYDROCHLORIDE USP, CODE 3210 (ESUB) AS MANUFACTURED IN ST. LOUIS, MO BUPRENORPHINE BASE EP, CODE 3205(ESUB) AS MANUFACTURED IN ST. LOUIS, MO BOSENTAN MONOHYDRATE AS MANUFACTURED IN TAMIL NADU, INDIA BORMED RD804CF AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR BOREALIS AG BORMED TD109CF AS MANUFACTURED IN BERINGEN, BELGIUM FOR BOREALIS AG ILOPERIDONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA EPTIFIBATIDE AS MANUFACTURED IN MILAN, ITLAY AND FROSINONE, ITALY ACYCLOVIR AS MANUFACTURED IN HANGZHOU, P.R. CHINA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD SIMVASTATIN AMMONIUM SALT AS MANUFACTURED IN ZHEJIANG, CHINA ETODOLAC AS MANUFACTURED IN TEKIRDAG, TURKEY ARIPIPRAZOLE AS MANUFACTURED IN TEKIRDAG, TURKEY VACUUM STERILE VIALS AS MANUFACTURED IN JIANGSU PROVINCE, CHINA DULOXETINE HYDROCHLORIDE (FROM (S)-MMAA) AS MANUFACTURED IN TAOYUAN, TAIWAN 875.0040U N-C ENCAPSULATED MENTHOL AS MANUFACTURED IN GENEVA, IL BUFFERED OXACILLIN SODIUM STERILE AS MANUFACTURED IN VILLADOSE (RO) ITALY AMLODIPINE BESILATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA EFAVIRENZ (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA BORTEZOMIB (ESUB) AS MANUFACTURED IN KARNATAKA INDIA ARMODAFINIL AS MANUFACTURED IN GUJARAT INDIA TETRABENAZINE(NON-STERILE BULK DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA FOR CHEMWERTH INC. LAMIVUDINE, USP (FORM I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ROPIVACAINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA CEVIMELINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC SCI BOND HEAT SEAL COATINGS AS MANUFACTURED IN FARMINGDALE, NJ CROSCARMELLOSE SODIUM, PH.EUR., NF, JP AS MANUFACTURED IN GUJARAT, INDIA FOR JRS PHARMA GMBH & CO. KG NATURAL AND ARTIFICIAL BUBBLEGUM FLAVOR FU-3869 AS MANUFACTURED IN BETHLEHEM, PA CONTAINER & CLOSURE AS MANUFACTURED IN GYEONGGI-DO, KOREA

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4Q2012EXCEL DMF# 24954 24955 24956 24957 A 24958 24959 A 24960 A 24961 A 24962 24963 A 24964 24965 24966 A 24967 A 24968 24969 A 24970 A 24971 A 24972 A 24973 24974 A 24975 A 24976 24977 24978 A 24979 A 24980 A 24981 A II 5/16/2011 II 5/21/2011 III 5/23/2011 A A II II II 5/25/2011 5/18/2011 5/20/2011 II 5/18/2011 SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO LTD HETERO DRUGS LTD LUNAN NEW TIME BIO TECH CO LTD A II III 5/25/2011 5/1/2011 V 5/7/2011 MICROTROL STERILISATION SERVICES PVT LTD HETERO DRUGS LTD ESKAY PACKAGING II 5/16/2011 CHEMAGIS LTD II 5/24/2011 RANBAXY LABORATORIES LTD A II II 10/14/2011 8/27/2012 II 4/29/2011 A A II II IV 5/20/2011 7/6/2011 5/18/2011 A II II 5/5/2011 5/18/2011 SYN TECH CHEM AND PHARM CO LTD IV 5/9/2011 HENKEL CORP II 5/5/2011 AESICA PHARMACEUTICALS LTD A II II 6/6/2011 5/2/2011 CTX LIFE SCIENCES PVT LTD SHANGHAI DONGYUE BIOCHEM CO LTD STATUS Type SUBMIT DATE A A A II II II III 5/6/2011 10/13/2011 5/17/2011 5/17/2011 HOLDER PIRAMAL HEALTHCARE LTD JUBILANT LIFE SCIENCES LTD SM BIOMED SDN BHD DOCTORPACK INDIA PVT LTD SUBJECT

4Q2012

TRAMADOL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ZIPRASIDONE HYDROCHLORIDE USP(ESUB) AS MANUFACTURED IN MYSORE, INDIA ERYTHROMYCIN BASE AS MANUFACTUED IN KEDAH DARUL AMAN, MALAYSIA PLASTIC CONTAINER CLOSURE SYSTEMS FOR 'N' DESIGN AS MANUFACTURED IN BANGALORE, INDIA LAMOTRIGINE USP (ESUB)AS MANUFACTURED IN GUJARAT, INDIA CLOPIDOGREL BISULFATE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA FOR SHANGHAI DONGYUE BIOCHEM CO., LTD PAROXETINE HYDROCHLORIDE HEMIHYDRATE AS MANUFACTURED IN NORTHUMBERLAND, UK DURO-TAK 87-6908 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY, NC DICLOFENAC EPOLAMINE AS MANUFACTURED IN TAINAN CITY, TAIWAN

ZHEJIANG HISUN PHARMACEUTICAL CO LTD TAZOBACTAM AS MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF CHINA SANDOZ GMBH TEMSIROLIMUS AS MANUFACTURED IN TYROL, AUSTRIA IPCA LABORATORIES LTD PHOSPHAGENICS LTD TRIAMTERENE (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA TOCOPHEROL PHOSPHATES(TPH) NOVEL DELIVERY PLATFORM AS MANUFACTURED IN VICTORIA, AUSTRALIA SOUTHWEST SYNTHETIC PHARMACEUTICAL SIMVASTATIN AMMONIUM SALT AS MANUFACTURED IN CHONGQING, P. R. CHINA CO LTD APICORE LLC NADOLOL, USP AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC CF PHARMA LTD CISATRACURIUM BESYLATE VERSION FB1 AS MANUFACTURED IN BUDAPEST, HUNGARY ATAZANAVIR SULFATE AS MANUFACTURED IN MAHARASHTRA, INDIA FOR RANBAXY LABORATORIES LIMITED IMATINIB MESYLATE ALPHA FORM AS MANUFACTURED IN BEER SHEVA, ISRAEL, A.P., INDIA FOR CHEMAGIS LTD ETHYLENE OXIDE STERILISATION AS MANUFACTURED IN MAHARASHTRA, INDIA RABEPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA ALUMINIUM COLLAPSIBLE TUBES SUITABLE FOR PACKAGING PHARMACEUTICAL DOSAGES AS MANUFACTURED IN GOA, INDIA EMTRICITABINE AS MANUFACTURED IN SHIJIAZHUANG, P.R. CHINA CLOPIDOGREL BISULFATE (FORM-I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA MYCOPHENOLIC ACID AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA

JINAN JINDA PHARMACEUTICAL CHEMISTRY NITROFURANTOIN MONOHYDRATE AS MANUFACTURED IN SHANDONG, CHINA CO LTD DOCTORPACK INDIA PVT LTD PLASTIC CONTAINER CLOSURE SYSTEM 'S' DESIGN AS MANUFACTURED IN BANGALORE, INDIA JINAN JINDA PHARMACEUTICAL CHEMISTRY NITROFURANTOIN AS MANUFACTURED IN SHANDONG, CHINA CO LTD CKD BIO CORP MYCOPHENOLATE MOFETIL, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN KYUNGGI-DO, SOUTH KOREA

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4Q2012EXCEL DMF# 24982 24983 24984 A 24985 24986 24987 A 24988 24989 24990 24991 A 24992 24993 A 24994 24995 A 24996 24997 A 24998 24999 25000 25001 25002 A 25003 25004 25005 A 25006 A 25007 A 25008 A 25009 25010 25011 25012 A A A A II II II III 6/3/2011 5/20/2011 5/31/2011 6/3/2011 II 6/1/2011 TOKO PHARMACEUTICAL INDUSTRIES CO LTD SEQUENT SCIENTIFIC LTD KOPRAN LTD PARABOLIC DRUGS LTD SCHOTT NAIGAI KK II 6/1/2011 PHARMAZELL VIZAG PRIVATE LTD II 5/31/2011 A A II IV II 11/4/2011 5/26/2011 5/19/2011 LUPIN LTD UNGERER AND CO ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD TORONTO RESEARCH CHEMICALS INC A A A A II II II II III 5/27/2011 5/30/2011 10/24/2011 5/31/2011 6/1/2011 HETERO DRUGS LTD FARMHISPANIA SA INDOCO REMEDIES LTD MACLEODS PHARMACEUTICALS LTD FORMOSA CHEMICALS AND FIBRE CORP A II II 5/27/2011 6/7/2011 SINOMEGA BIOTECH ENGINEERING CO LTD AUROBINDO PHARMA LTD OMEGA-3 REFINED FISH OIL AS MANUFACTUED IN ZHEJIANG, CHINA A III II 5/27/2011 5/25/2011 MYLAN TECHNOLOGIES INC A II III 5/27/2011 5/27/2011 CORDEN PHARMA COLORADO INC NUSSBAUM MATZINGEN AG A A A II II III III 5/27/2011 5/26/2011 5/26/2011 5/26/2011 SANDOZ GMBH PIRAMAL HEALTHCARE LTD HMC POLYMERS CO LTD DOCTORPACK INDIA PVT LTD FILGRASTIM (G-CSF) AS MANUFACTURED IN TYROL, AUSTRIA TOLCAPONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA PURELL RP271M AS MANUFACTURED IN RAYONG, THAILAND A A IV IV III 5/25/2011 5/25/2011 8/26/2011 FONA INTERNATIONAL INC FONA INTERNATIONAL INC RADPHARM SCIENTIFIC 828.0030U CITRUS BLEND FLAVOR, ART AS MANUFACTURED IN GENEVA, IL 862.0061U N-C LEMON FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA IL RADPHARM STERILE EVACUATED GLASS VIALS 10ML, 20ML, 30ML ( ESUB) AS MAnUFACTURED IN BELCONNEN, AUSTRALIA STATUS Type SUBMIT DATE A P IV 5/25/2011 II 5/25/2011 HOLDER HETERO DRUGS LTD *** PENDING FILING REVIEW *** FONA INTERNATIONAL INC SUBJECT OMEPRAZOLE MAGNESIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA

4Q2012

915.0527U N-C STRAWBERRY FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL

PLASTIC CONTAINTER CLOSURE SYSTEM 'MRL' DESIGN AS MANUFACTURED IN BANGALORE, INDIA LINACLOTIDE AS MANUFACTURED IN BOULDER, COLORADO ALUMINUM CANS AS MANUFACTURED IN MATZINGEN, SWITZERLAND AND FRANKENBERG AND RIELASINGEN, GERMANY MEDIRELEASE 2500 AS MANUFACTURED IN ST. ALBANS, VERMONT

ST GOBAIN PERFORMANCE PLASTICS CORP C-FLEX ULTRA TPE TUBING AS MANUFACTURED IN CLEARWATER, FL

ARIPIPRAZOLE (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA PROGUANIL HYDROCHLORIDE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA CISATRACURIUM BESYLATE AS MANUFACTUED IN MONTMELO, SPAIN QUETIAPINE FUMARATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA EMTRICITABINE AS MANUFACTURED IN VALSAD GUJARAT, INDIA TAIRIPRO POLYPROPYLENE RESINS: K1023, T3002, F4007, K4515 & K4535 AS MANUFACTURED IN TAIPEI, TAIWAN EFAVIRENZ USP (ESUB) AS MANUFACTUED IN MAHARASHTRA, INDIA #41288 NATURAL MELON WONF FLAVOR AS MANUFACTURED IN BETHLEHEM, PA LEVETIRACETAM AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA 2-AMINO-3,8-DIMETHYLIMIDAZOL[4,5-F]QUINOXALINE-2-14C AS MANUFACTURED IN TORONTO, CANADA RISEDRONATE SODIUM HEMIPENTAHYDRATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA TAMIBAROTENE AS MANUFACTURED IN HOKKAIDO, JAPAN ZIDOVUDINE AS MANUFACTURED IN KARNATAKA, INDIA ATENOLOL AS MANUFACTURED IN MAHARASHTRA STATE, INDIA PENTOSAN POLYSULFATE SODIUM AS MANUFACTURED IN HARYANA, INDIA INJECTION VIALS AND SCREW NECK VIALS IN CLEAR GLASS AND AMBER GLASS AS MANUFACTURED IN OSAKA, JAPAN

Page 766

4Q2012EXCEL DMF# 25013 25014 A 25015 A 25016 A 25017 A 25018 25019 A 25020 25021 25022 25023 25024 25025 25026 A 25027 A 25028 25029 25030 25031 A 25032 A 25033 25034 25035 A 25036 25037 25038 25039 A 25040 25041 A 25042 A III 6/7/2011 3M DRUG DELIVERY SYSTEMS A II III 7/1/2011 6/2/2011 EMCURE PHARMACEUTICALS LTD INEOS SERVICES BELGIUM NV A A A II III IV II 6/9/2011 6/8/2011 4/30/2011 7/1/2011 A A III II II 5/3/2011 6/10/2011 5/9/2011 II 6/18/2011 A A A II II II II 6/9/2011 6/9/2011 2/4/2011 6/23/2011 HETERO LABS LTD HETERO LABS LTD VITAL LABORATORIES PVT LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD SABIC PETROCHEMICALS BV DK PHARMA CHEM PVT LTD CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTD MACLEODS PHARMACEUTICALS LTD SOLVIN SA BALAJI AMINES LTD UNIT III EMCURE PHARMACEUTICALS LTD III 6/1/2011 KURARAY TRADING CO LTD A A A A A A II II II II II II III 6/6/2011 6/1/2011 6/27/2011 6/8/2011 6/8/2011 6/7/2011 5/25/2011 SANOFI CHIMIE GLENMARK GENERICS LTD INTERQUIM SA TEVA PHARMACEUTICAL INDUSTRIES LTD POLYPEPTIDE LABORATORIES INC TEXOL SRL A II IV 10/11/2011 6/1/2011 NECTAR LIFESCIENCES LTD LIPOID GMBH II 12/22/2011 NECTAR LIFESCIENCES LTD II 2/21/2012 NECTAR LIFESCIENCES LTD II 9/5/2011 AMI ORGANICS PVT LTD STATUS Type SUBMIT DATE A II II 6/7/2011 9/5/2011 HOLDER SHARON BIO MEDICINE LTD AMI ORGANICS PVT LTD SUBJECT KETOCONAZOLE USP AS MANUFACTURED IN MAHARASHTRA, INDIA

4Q2012

1- (2,3-DICHLORO PHENYL) PIPERAZINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA 1-[2-(2-HYDROXY ETHOXY) ETHYL] PIPERAZINE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA CEFEPIME HYDROCHLORIDE USP (STERILE) (ESUB) AS MANUFACTURED IN DISTRICT MOHALI, (PUNJAB) INDIA CEFEPIME HYDROCHLORIDE (NON-STERILE) DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN DISTRICT MOHALI, (PUNJAB) INDIA PYCA (ESUB) AS MANUFACTURED IN DISTRICT MOHALI, (PUNJAB) INDIA LIPOID LIPIDMIX HSPC/MPEG2000-DSPE/CHOLESTEROL (3/1/1) AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY SEMULOPARIN SODIUM AS MANUFACTURED IN SINGAPORE MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN GUJARAT STATE, INDIA OZENOXACIN AS MANUFACTUED IN BARCELONA, SPAIN SIMVASTATIN (ETHANOL PROCESS) AS MANUFACTURED IN DEBRECEN, HUNGARY LINACLOTIDE DRUG SUBSTANCE AS MANUFACTURED IN TORRANCE, CA PERFORATED LAMINATE TOPSHEET 43 GSM AS MANUFACTURED IN ALLANO(PE), ITALY KG001, POLYPROPYLENE-KNITTED BACKING CLOTH FOR MEDICAL PATCHES AS MANUFACTURED IN SAIJO-SHI, TOKYO, KAWAKITA-GUN, SABAE-SHI, JAPAN FOR KURARAY TRADING CO., LTD. EFAVIRENZ(FORM-H1) AS MANUFACTURED IN ANDHRA PRADESH, INDIA TELMISARTAN, USP (FORM A) AS MANUFACTURED IN ANDHRA PRADESH, INDIA RESERPINE USP AS MANUFACTURED IN GUJARAT, INDIA ARMODAFINIL (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA RABEPRAZOLE SODIUM (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA SABIC PP PCGR25 00900 AS MANUFACTURED IN AI GELEEN, THE NETHERLANDS FENOFIBRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA AMPICILLIN TRIHYDRATE AS MANUFACTURED IN SHIJIAZHUANG, P.R. CHINA DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA SOLVIN 372HA AS MANUFACTURED IN TAVAUX, FRANCE AND RHEINBERG, GERMANY POVIDONE USP-31 AS MANUFACTURED IN MAHARASHTRA STATE, INDIA SEVELAMER CARBONATE (PROCESS II) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA MELPHALAN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ELTEX MED HD5226EA-M AS MANUFACTURED IN LAVERA, FRANCE FOR INEOS SERVICES BELGIUM NV 3M COTRAN 9696 TAN TRICOT FABRIC TAPE AS MANUFACTURED IN BROOKINGS, SD FOR 3M DRUG DELIVERY SYSTEMS

POLYPEPTIDE LABORATORIES SWEDEN AB LINACLOTIDE DRUG SUBSTANCE AS MANUFACTURED IN LIMHAMN, SWEDEN

Page 767

4Q2012EXCEL DMF# 25043 25044 A 25045 A 25046 25047 A 25048 A 25049 25050 25051 25052 25053 A 25054 A 25055 25056 A 25057 25058 25059 A 25060 25061 A 25062 25063 A 25064 25065 25066 A 25067 A 25068 A 25069 25070 25071 A A A II II III 6/22/2011 6/20/2011 6/10/2011 APOTEX PHARMACHEM INDIA PVT LTD R.N. LABORATORIES PVT LTD. RKW SE II 6/22/2011 II 6/18/2011 ZHEJIANG XIANJU PHARMACEUTICAL CO LTD MOEHS IBERICA SL A A II II III 6/21/2011 6/16/2011 6/14/2011 MSN PHARMACHEM PVT LTD RAKS PHARMA PVT LTD LORMAC INDUSTRIAL DISTRIBUTORS LTD A II III 6/16/2011 6/14/2011 RAKS PHARMA PVT LTD RAVIRAJ FOILS LTD DOXYCYCLINE, USP, AS MANUFACTURED IN ANDHRA PRADESH, INDIA A II II 6/14/2011 6/20/2011 CHEMSPEC CHEMICALS PVT LTD A A III II III 5/12/2011 6/15/2011 6/17/2011 A II II 7/20/2011 6/17/2011 CADILA HEALTHCARE LTD HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTD AMCOR FLEXIBLES AS RA CHEM PHARMA LTD MINNESOTA RUBBER AND PLASTICS II 6/14/2011 ACEBRIGHT INDA PHARMA PRIVATE LTD A A A A II II II II IV 6/9/2011 6/2/2011 7/5/2011 6/16/2011 6/8/2011 PCAS PORTON FINE CHEMICALS LTD UNICHEM LABORATORIES LTD AMINO CHEMICALS LTD 3M DRUG DELIVERY SYSTEMS II 6/14/2011 MACLEODS PHARMACEUTICALS LTD A IV III 6/9/2011 6/15/2011 NIPPON FINE CHEMICAL CO LTD TOPPAN PRINTING CO LTD III 6/13/2011 MITSUI ELASTOMERS SINGAPORE PTE LTD STATUS Type SUBMIT DATE A II II 6/13/2011 6/13/2011 HOLDER SANDOZ PRIVATE LTD CRYSTAL PHARMA SAU SUBJECT LANSOPROZOLE AS MANUFACTURED IN MAHARASHTRA, INDIA

4Q2012

OLOPATADINE HYDROCHLORIDE, USP (PROCESS II) AS MANUFACTURED IN BOECILLO (VALLADOLID), SPAIN TAFMER MY-1, MY-2, XM7070, XM7080 AND NOTIO PN-9060 AS MANUFACTURED IN JURONG ISLAND, SINGAPORE AND CHIBA, JAPAN FOR MITSUI ELASTOMERS SINGAPORE PTE LTD PRESOME ESI AS MANUFACTURED IN TAKASAGO-CITY, JAPAN LOW ADSORPTION LAMINATED PACKAGING MATERIAL AS MANUFACTURED IN GUNMA, JAPAN ZIPRASIDONE HYDROCHLORIDE AS MANUFACTURED IN CITY: VALSAD GUJARAT, INDIA ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN LIMAY, FRANCE ROSUVASTATIN CALCIUM AS MANUFACTURED IN CHONGQING, P.R. CHINA BRIMONIDINE TARTRATE (ESUB) AS MANUFACTURED IN ROHA, DIST. RAIGAD, INDIA FESOTERODINE FUMARATE AS MANUFACTURED IN MARSA, MALTA 3M COTRAN 9714 POLYETHYLENE FILM AS MANUFACTURED IN BROOKINGS, SD FOR 3M DRUG DELIVERY SYSTEMS CAPECITABINE USP[DRUG SUBSTANCE (NON-STERILE)] AS MANUFACTURED IN KARNATAKA, INDIA PROPAFENONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FINASTERIDE AS MANUFACTURED IN HUBEI, CHINA OPP40/ALU9/OPP40 AS MANUFACTURED IN DRAMMEN, NORWAY PHTHALAZINONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA POLYISOPRENE RUBBER FOR SEALING AND OTHER MEDICAL-RELATED APPLICATIONS IN MEDICAL DEVICES AS MANUFACTURED IN GUANGDONG, P. R. CHINA FOR MINNESOTA RUBBER & PLASTICS TRICLOCARBAN AS MANUFACTURED IN MAHARASHTRA, INDIA

PHARMACEUTICAL WORKS POLPHARMA SA MONTELUKAST SODIUM AS MANUFACTURED IN STAROGARD GDANSKI, POLAND

CHILD RESISTANT BLISTER PACK LIDDING MATERIAL (PLAIN / PRINTED)' AS MANUFACTURED IN GUJARAT, INDIA PREGABALIN[ROUTE CODE: "PU"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA CITALOPRAM HYDROBROMIDE, USP, AS MANUFACTURED IN ANDHRA PRADESH, INDIA LORMAC TYPE 40 POLYETHYLENE AS MANUFACTURED IN BRIGHOUSE, UNITED KINGDOM AND CORK, IRELAND FOR LORMAC INDUSTRIAL DISTRIBUTORS LTD. METHYLPREDNISOLONE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG, CHINA ARTICAINE HCL AS MANUFACTURED IN BELGIUM AND RUBI (BCN), SPAIN FOR MOEHS IBERICA, S. L. LETROZOLE USP AS MANUFACTURED IN KARNATAKA STATE, INDIA CHLORHEXIDINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA HYFOL PE SOFT TEXTILE - 45701 AS MANFACTURED IN WASSERBURG, GERMANY

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4Q2012EXCEL DMF# 25072 25073 25074 25075 A 25076 A 25077 A 25078 25079 25080 25081 25082 25083 25084 I 25085 A 25086 A 25087 25088 A 25089 25090 25091 A 25092 25093 25094 A 25095 25096 A 25097 A 25098 25099 25100 25101 25102 A 25103 A II 7/20/2011 FRESENIUS KABI ONCOLOGY LTD A A A A II II II III II 6/30/2011 6/30/2011 7/4/2011 7/1/2011 9/21/2011 BACHEM SA ALEMBIC PHARMACEUTICALS LTD APOTEX PHARMACHEM INDIA PVT LTD AGI GLASPAC BHONGIR UNIT SHILPA MEDICARE LTD II 6/29/2011 MOEHS IBERICA SL A II II 6/24/2011 7/1/2011 A A II II II 7/26/2011 6/30/2011 7/14/2011 USV LIMITED RELIABLE BIOPHARMACEUTICAL CORP NANTONG JINGHUA PHARMACEUTICAL CO LTD JOYANG LABORATORIES MUSTAFA NEVZAT ILAC SANAYII AS A A II II IV 6/29/2011 7/27/2011 6/20/2011 REGIS TECHNOLOGIES INC EXCELLA GMBH SUMITOMO SEIKA CHEMICALS CO LTD A II II 6/28/2011 6/29/2011 II 6/12/2011 II 6/12/2011 A A A A I A II III II II II II II 8/26/2011 6/10/2011 4/20/2011 7/20/2009 6/17/2011 6/18/2011 6/28/2011 SUN PHARMACEUTICAL INDUSTRIES LTD UNITIKA LTD F.I.S.-FABBRICA ITALIANA SINTETICI S.P.A. AARTI INDUSTRIES LTD MATRIX PHARMA GROUP XIAMEN LTD MYLAN LABORATORIES LTD RANBAXY LABORATORIES LTD III 6/18/2011 GREEN PACK FOILS PRIVATE LTD II 6/27/2011 MYLAN LABORATORIES LTD STATUS Type SUBMIT DATE P A A II II II 6/24/2011 6/24/2011 6/24/2011 HOLDER *** PENDING FILING REVIEW *** APOTEX PHARMACHEM INDIA PVT LTD APOTEX PHARMACHEM INDIA PVT LTD COVALENT LABORATORIES PRIVATE LTD PALIPERIDONE AS MANUFACTURED IN KARNATAKA STATE, INDIA ALPRAZOLAM USP AS MANUFACTURED IN KARNATAKA STATE, INDIA SUBJECT

4Q2012

CEFUROXIME AXETIL USP (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ELETRIPTAN HYDROBROMIDE (PROCESS 2) AS MANUFACTURED IN ANDHRA PRADESH, INDIA CHILD RESISTANT BLISTER PACK LIDDING FOIL (PLAIN / PRINTED)'. AS MANUFACTURED IN GUJARAT, INDIA ZOLMITRIPTAN (ESUB) AS MANUFACTURED IN GUJARAT, INDIA EMBLET PET,S AS MANUFACTURED IN KYOTO, JAPAN FOR UNITIKA LTD. ESOMEPRAZOLE MAGNESIUM TRIHYDRATE AS MANUFACTURED IN VICENZA, ITALY IFOSFAMIDE AS MANUFACTURED IN MAHARASHTRA, INDIA ZIDOVUDINE USP AS MANUFACTURED IN XIAMEN, P.R. CHINA S-PREGABALIN (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

QUETIAPINE FUMARATE (NON-STERILE BULK) AS MANUFACTURED IN HARYANA, INDIA FOR RANBAXY LABORATORIES LIMITED ZHEJIANG HUAFANG PHARMACEUTICAL CO CEFCAPENE PIVOXIL HYDROCHLORIDE HYDRATE AS MANUFACTURED IN ZHEJIANG, LTD CHINA ZHEJIANG HUAFANG PHARMACEUTICAL CO CEFDITOREN PIVOXIL AS MANUFACTURED IN ZHEJIANG, CHINA LTD JOHNSON MATTHEY PHARMA SERVICES 3011.H AS MANUFACTURED IN DEVENS, MA HETERO DRUGS LTD CITALOPRAM HYDROBROMIDE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA DAPSONE, USP AS MANUFACTURED IN MORTON GROVE, IL BUPIVACAINE (S) HYDROCHLORIDE (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY PEO-1NF, A LOW MOLECULAR WEIGHT POLYETHYLENE OXIDE AS MANUFACTURED IN HYOGO, JAPAN EPTIFIBATIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA FONDAPARINUX SODIUM AS MANUFACTURED IN ST. LOUIS, MO FLUCYTOSINE (ESUB) AS MANUFACTURED IN NANTONG JIANGSU, CHINA BACITRACIN ZINC AS MANUFACTURED IN JIANGSU, CHINA NON-STERILE SULBACTAM SODIUM AS MANUFACTURED IN CAYIROVA-KOCAELI, TURKEY SERTRALINE HCL FORM 1 (SCHIFF BASE) AS MANUFACTURED IN RUBI (BARCELONA), SPAIN FOR MOEHS IBERICA S.L. TOPOTECAN HYDROCLORIDE AS MANUFACTURED IN VIONNAZ, SWITZERLAND BOSENTAN AS MANUFACTURED IN GUJARAT, INDIA VORICONAZOLE AS MANUFACTURED IN BANGALORE, INDIA GLASS BOTTLES USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA PEMETREXED DISODIUM (HEMIPENTA HYDRATE) (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA DOCETAXEL(ESUB) AS MANUFACTURED IN WEST BENGAL, INDIA

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4Q2012EXCEL DMF# 25104 25105 25106 25107 25108 A 25109 25110 25111 25112 25113 25114 A 25115 25116 25117 A 25118 25119 25120 25121 25122 25123 25124 25125 25126 A 25127 A 25128 25129 A 25130 A 25131 25132 25133 25134 25135 A 25136 A III 7/12/2011 ARTUBE IRIDIUM INDUSTRIES INC A A A A II II II II II 7/5/2011 7/5/2011 7/5/2011 9/9/2011 7/5/2011 III 6/13/2011 A II II 6/30/2011 7/15/2011 II 5/11/2011 KOTHARI PHYTOCHEMICALS INTERNATIONAL HEMMO PHARMACEUTICALS PVT LTD A A A A A A A A II II II II II II III II III 7/12/2011 6/20/2011 6/30/2011 7/13/2011 7/13/2011 7/11/2011 7/12/2011 7/11/2011 7/14/2011 HETERO LABS LTD VITAL LABORATORIES PVT LTD SECOND PHARMA CO LTD HETERO LABS LTD HAINAN POLY PHARMACEUTICAL CO LTD PROCOS SPA MITSUI MINING AND SMELTING CO LTD LIFE TECHNOLOGIES CORP THE JENARD CO DIV FEY INDUSTRIES INC A A II II II 7/12/2011 7/12/2011 7/7/2011 HETERO LABS LTD HETERO LABS LTD MARAVIROC (FORM-B) AS MANUFACTURED IN ANDHRA PRADESH, INDIA A A A A A III III II IV III III 7/8/2011 7/8/2011 6/30/2011 7/8/2011 7/6/2011 5/16/2011 POLYCINE GMBH POLYCINE GMBH MYLAN LABORATORIES LTD GANGWAL CHEMICALS PVT. LTD. VITEX PACKAGING GROUP STATUS Type SUBMIT DATE A A A A II III II II II 7/4/2011 6/27/2011 7/6/2011 6/30/2011 5/31/2011 HOLDER MACLEODS PHARMACEUTICALS LTD PIONEER EXTRUDERS PVT LTD SANOFI AVENTIS CHIMIE YUNG ZIP CHEMICAL IND CO LTD OG CORP SUBJECT MONTELUKAST SODIUM AS MANUFACTURED IN GUJARAT, INDIA COLLAPSIBLE ALUMINIUM TUBES AS MANUFACTURED IN DAMAN, INDIA TRIMIPRAMINE MALEATE AS MANUFACTURED IN CEDEX, FRANCE DICLOFENAC ACID AS MANUFACTURED IN TAICHUNG, TAIWAN

4Q2012

POLYESTER KNITTING CLOTH FOR BACKING LINER AS MANUFACTURED IN FUKUI CITY, JAPAN FOR OG CORPORATION APP114 FILM AS MANUFACTURED IN SCHIFFWEILER, GERMANY APP218 FILM AS MANUFACTURED IN SCHIFFWEILER, GERMANY DEXLANSOPRAZOLE AMORPHOUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA SUCRALOSE USP AS MANUFACTURED IN MAHARASHTRA, INDIA VITEX POUCH 40493 AS MANUFACTURED IN SUFFOLK, VA

ST GOBAIN PERFORMANCE PLASTICS CORP D9899000-12 AS MANUFACTURED IN POESTENKILL, NEW YORK

IMATINIB MESYLATE AMORPHOUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA

PHARMACEUTICAL WORKS POLPHARMA SA ROSUVASTATIN CALCIUM AS MANUFACTURED IN STAROGARD GDANSKI, POLAND SAQUINAVIR MESYLATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA METHYLCOBALAMIN (MECOBALAMIN) AS MANUFACTURED IN GUJARAT, INDIA LEVETIRACETAM AS MANUFACTURED IN ZHEJIANG PROVINCE, P. R. CHINA MARAVIROC AMORPHOUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA GANCICLOVIR SODIUM AS MANUFACTURED IN ZHEJIANG, CHINA DIMIRACETAM AS MANUFACTURED IN CAMERI (NO) - ITALY OMNIBATCH AS MANUFACTURED IN CHIBA, JAPAN FOR POWDERTECH CO., LTD. HUMAN GROWTH FACTORS AS MANUFACTURED IN FREDERICK, MD DISCREET SLEEVE PACKAGING FOR ORAL CONTRACEPTIVES AS MANUFACTURED IN EDGERTON, MN FOR THE JENARD COMPANY, A DIVISION OF FEY INDUSTRIES, INC CHLORPROPAMIDE AS MANUFACTURED IN TAMILNADU, INDIA LEUPRORELIN PH.EUR. AS MANUFACTURED IN DISTRICT THANE, INDIA

SHANDONG LUKANG PHARMACEUTICAL CO SPECTINOMYCIN HYDROCHLORIDE HCI USP, NON-STERILE, BULK DRUG SUBSTANCE AS LTD MANUFACTURED IN SHANDONG, P. R. CHINA NEX PERFORMANCE FILMS NEX S9149 SINGLE-LAYER POLYETHYLENE SHEETING FILM AS MANUFACTURED IN TURNERS FALLS, MA AND MILTON, WI JOST CHEMICAL CO CALCIUM SUCCINATE, MONOHYDRATE AS MANUFACTURED IN ST. LOUIS, MO JOST CHEMICAL CO JOST CHEMICAL CO WATSON PHARMA PRIVATE LTD JOST CHEMICAL CO SODIUM PHOSPHATE DIBASIC, ANHYDROUS AS MANUFACTURED IN ST. LOUIS, MO MAGNESIUM SULFATE DRIED AS MANUFACTURED IN ST. LOUIS, MO AMBRISENTAN (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA SODIUM PHOSPHATE MONOBASIC, MONOHYDRATE AS MANUFACTURED IN ST. LOUIS, MO MONO LAYER AND COEX LAYER PLASTIC TUBES AS MANUFACTURED IN EAST STROUDSBURG, PA

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4Q2012EXCEL DMF# 25137 A 25138 A 25139 A 25140 A 25141 A 25142 25143 25144 A 25145 25146 25147 A 25148 A 25149 A 25150 A 25151 A 25152 25153 A 25154 25155 25156 25157 A 25158 25159 A 25160 A 25161 25162 A 25163 A III 7/25/2011 ELIX POLYMERS SL A II III 7/25/2011 7/27/2011 PCAS COLORS FOR PLASTICS INC TAZAROTENE AS MANUFACTURED IN TURKU, FINLAND FOR PCAS III 9/16/2011 HOSPIRA INC A II III 7/25/2011 7/26/2011 AMERICA STEM CELL INC JSR CORP A A A II II II V 5/20/2011 9/29/2011 11/14/2011 5/18/2011 AICELLOMILIM CHEMICAL CO LTD UNICHEM LABORATORIES LTD RELIANCE LIFE SCIENCES PVT LTD ROTEM INDUSTRIES LTD A II III 7/29/2011 7/19/2011 II 7/21/2011 ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTD ALKEM LABORATORIES LTD AMPACET CORP III 7/18/2011 PIRAMIDA DD II 7/25/2011 MEDICHEM SA II 3/4/2011 ALP PHARM BEIJING CO LTD A A II IV II 8/4/2011 7/19/2011 7/20/2011 JUBILANT HOLLISTERSTIER LLC UNGERER AND CO STERILE EVACUATED VIALS (ESUB) AS MANUFACTURED IN SPOKANE, WA A A II II II 8/20/2011 9/5/2011 8/6/2011 II 10/19/2011 III 6/6/2011 IV 7/15/2011 II 9/9/2011 STATUS Type SUBMIT DATE III 7/11/2011 HOLDER BASELL POLYOLEFINE ITALIA SRL SUBJECT

4Q2012

PURELL ACP 5231 D AS MANUFACTURED IN FRANKFURT AM MAIN AND MUNCHSMUNSTER, GERMANY FOR BASELL POLYOLEFINE ITALIA S. R. L. CHEMWERTH INC CLOCORTOLONE PIVALATE NON-STERILE BULK DRUG (ESUB) AS MANUFACTURED IN TIANJIN, PR CHINA JIANGSU ZODIAC MARINE BIOTECHNOLOGY EMPTY HARD CARRAGEENAN CAPSULES AS MANUFACTURED IN JIANGSU, CHINA CO LTD STYROLUTION GMBH TERLUX 2822 HD AS MANUFACTURED IN LUDWIGSHAFEN AND SCHWARZHEIDE, GERMANY LUPIN LTD L-5-METHYL TETRAHYDROFOLATE CALCIUM (AMORPHOUS)(ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ARCH PHARMALABS LTD DOCETAXEL ANHYDROUS USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ARCH PHARMALABS LTD CADILA HEALTHCARE LTD ZYFINE DOCETAXEL TRIHYDRATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ERLOTINIB HYDROCHLORIDE (FORM-A) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA

ARTIFICIAL PINA COLADA FLAVOR FT-11512 AS MANUFACTURED IN BETHLEHEM, PA

ZHEJIANG HISUN PHARMACEUTICAL CO LTD SIROLIMUS AS MANUFACTURED IN ZHEJIANG, PEOPLE'S REPUBLIC OF CHINA DOXERCALCIFEROL AS MANUFACTURED IN LIAONING PROVINCE, CHINA FOR ALP PHARM BEIJING CO., LTD. CHLORHEXIDINE GLUCONATE SOLUTION (DGLP) AS MANUFACTURED IN CELRA (GIRONA), SPAIN PHARMACEUTICAL GLASS PACKAGING - AMPOULES AND VIALS AS MANUFACTURED IN SESVETE, CROATIA AMANTADINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJINAG PROVINCE, P.R. CHINA LANSOPRAZOLE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA 173834 TRANS GREEN SMC PE MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA AND HEATH, OH ADF-03 (CLEAN BAG) AS MANUFACTURED IN GYEONGGI-DO, KOREA TOLTERODINE TARTARATE (ESUB) AS MANUFACTURED IN DIST. RAIGAD, INDIA ROCURONIUM BROMIDE USP (ESUB) AS MANUFACTURED IN NAVI MUMBAI, INDIA CASSETTE FOR THE PRODUCTION OF FLUORINE-18 FLUDEOXYGLUCOSE ON THE TRACERLAB MX FDG SYNTHESIS UNIT, TYPE B AS MANUFACTURED IN MISHOR YAMIN , ISRAEL ASC-1401 AS MANUFACTURED IN ALACHUA, FLORIDA FOR AMERICA STEM CELL, INC JSR DYNARON SERIES (HYDROGENATED STYRENE BUTADIENE COPOLYMER) AS MANUFACTURED IN MIE, JAPAN ANSYR SYRINGE DRUG CONTAINER (ESUB) AS MANUFACTURED IN ROCKY MOUNT, NC

THERMOPLASTIC RESIN COLORANT MASTERBATCH N06534 BROWN AS MANUFACTURED IN ELK GROVE VILLAGE, IL AND SPARTANBURG, SC ELIX ABS M210TF, VARIOUS COLORS AS MANUFACTURED IN LA CANONJA, SPAIN

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4Q2012EXCEL DMF# 25164 A 25165 A 25166 A 25167 A 25168 A 25169 25170 25171 A 25172 25173 25174 A 25175 A 25176 A 25177 A 25178 A 25179 A 25180 25181 25182 A 25183 A 25184 A 25185 A 25186 A 25187 A 25188 A 25189 A II 12/21/2011 GLAXOSMITHKLINE LLC II 10/25/2011 GILEAD SCIENCES INC II 10/24/2011 GILEAD SCIENCES INC II 8/22/2011 DR REDDYS LABORATORIES LTD II 8/11/2011 DR REDDYS LABORATORIES LTD III 7/29/2011 3M DRUG DELIVERY SYSTEMS V 7/29/2011 P A II II 7/20/2011 8/3/2011 III 2/23/2011 III 8/2/2011 III 8/2/2011 III 8/2/2011 II 7/29/2011 QILU PHARMACEUTICAL CO LTD A A II II II 9/9/2011 7/20/2011 8/2/2011 EMCURE PHARMACEUTICALS LTD GOLDEN SHELL BIOCHEMICAL CO LTD A P III 7/25/2011 II 7/15/2011 II 7/1/2011 KOTHARI PHYTOCHEMICALS INTERNATIONAL TAI HENG INDUSTRY CO LTD *** PENDING FILING REVIEW *** CV HOLDINGS LLC II 7/19/2011 LI COR BIOSCIENCES INC II 3/30/2011 AUCTUS PHARMA LTD II 4/14/2011 HYBIO PHARMACEUTICAL CO LTD STATUS Type SUBMIT DATE IV 7/26/2011 HOLDER UNGERER AND CO SUBJECT

4Q2012

NATURAL AND ARTIFICIAL CHERRY FLVP FT-9496 AS MANUFACTURED IN BETHLEHEM, PA BIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN GUANGDONG, P. R. CHINA PANTOPRAZOLE SODIUM SESQUIHYDRATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA IRDYE 800CW NHS ESTER(DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN MORTON GROVE, IL FOR LI-COR BIOSCIENCES, INC. TOLBUTAMIDE USP AS MANUFACTURED IN TAMILNADU, INDIA BOSENTAN MONOHYDRATE AS MANUFACTURED IN SHANGHAI, P.R. CHINA 5ML GLASS COATED PARENTERAL DRUG VIAL AS MANUFACTURED IN AUBURN, ALABAMA IBANDRONATE SODIUM (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA CHITOSAN AS MANUFACTURED IN ZHEJIANG, CHINA

PHARMACEUTICAL WORKS POLPHARMA SA VARDENAFIL HYDROCHLORIDE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND OLANZAPINE AS MANUFACTURED IN SHANDONG PROVINCE, PEOPLE'S REPUBLIC OF CHINA JIANGSU BEST NEW MEDICAL MATERIAL CO BROMOBUTYL RUBBER STOPPERS FOR INFUSION BOTTLES AS MANUFACTURED IN LTD JIANGSU, CHINA JIANGSU BEST NEW MEDICAL MATERIAL CO BROMOBUTYL RUBBER STOPPERS FOR INJECTION VIALS AS MANUFACTURED IN LTD JIANGSU, CHINA JIANGSU BEST NEW MEDICAL MATERIAL CO FREEZE DRYING BROMOBUTYL RUBBER STOPPERS FOR INJECTION VIALS AS LTD MANUFACTURED IN JIANGSU, CHINA TEKNOR COLOR CO 47,264CP MOM BLUE 25/1 AS MANUFACTURED IN HENDERSON, KY AND JACKSONVILLE, TX *** PENDING FILING REVIEW *** GOLDEN SHELL BIOCHEMICAL CO LTD SHOUGUANG FUKANG PHARMACEUTICAL CO LTD ECKERT AND ZIEGLER EUROTOPE GMBH N-ACETYL-D-GLUCOSAMINE AS MANUFACTURED IN ZHEJIANG, CHINA CLOZAPINE AS MANUFACTURED IN SHOUGUANG CITY, P.R. OF CHINA MODULAR-LAB RADIOPHARMACEUTICAL SYNTHESIS SYSTEMS AS MANUFACTURED IN BERLIN, GERMANY 3M SCOTCHPAK 9758 POLYESTER FILM AS MANUFACTURED IN DECATUR, ALABAMA, GREENVILLE, SC AND HUTCHINSON, MN FOR 3M DRUG DELIVERY SYSTEMS BROMFENAC SODIUM SESQUIHYDRATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA O-DESMETHYL VENLAFAXINE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ELVITEGRAVIR (ESUB) AS MANUFACTURED IN ALBERTA, CANADA, VICENZA, ITALY AND KYUNGGI-DO, SOUTH KOREA FOR GILEAD SCIENCES, INC COBICISTAT ON SILICON DIOXIDE (ESUB) AS MANUFACTURED IN ALBERTA, CANADA AND KYUNGGI-DO, SOUTH KOREA FOR GILEAD SCIENCES, INC ALBUTEROL (ESUB) AS MANUFACTURED IN ANGUS, UNITED KINGDOM AND EVREUX, FRANCE FOR GLAXO GROUP LIMITED D/B/A GLAXOSMITHKLINE Page 772

4Q2012EXCEL DMF# 25190 A 25191 A 25192 A 25193 25194 25195 A 25196 A 25197 25198 25199 A 25200 A 25201 25202 I 25203 I 25204 25205 25206 25207 A 25208 A 25209 A 25210 A 25211 A 25212 A 25213 A 25214 A 25215 A III 8/18/2011 II 8/1/2011 II 8/10/2011 ANHUI BBCA LIKANG PHARMACEUTICAL CO LTD SHOUGUANG FUKANG PHARMACEUTICAL CO LTD SABIC PETROCHEMICALS BV II 8/16/2011 II 8/5/2011 ZHEJIANG APELOA KANGYU BIO PHARMACEUTICAL CO LTD HOSPIRA BOULDER INC IV 8/12/2011 NEOPHARM CO LTD III 8/15/2011 MITSUBISHI GAS CHEMICAL CO INC III 8/9/2011 ROY AND LECLAIR EMBALLAGE INC A A A II II II II 8/1/2011 7/26/2011 7/27/2011 7/11/2011 FIS FABBRICA ITALIANA SINTETICI SPA FIS FABBRICA ITALIANA SINTETICI SPA FIS FABBRICA ITALIANA SINTETICI SPA II 7/30/2011 QILU PHARMACEUTICAL CO LTD A II II 8/5/2011 7/29/2011 II 8/5/2011 ZHEJIANG AUSUN PHARMACEUTICAL CO LTD LONZA AG QILU PHARMACEUTICAL CO LTD A A II II III 8/10/2011 8/10/2011 8/5/2011 SYMBIOTEC PHARMALAB LTD GMT FINE CHEMICALS SA 3M DRUG DELIVERY SYSTEMS V 6/3/2011 A A II II II 6/1/2011 8/9/2011 8/1/2011 II 8/3/2011 FIDIA FARMACEUTICI SPA DIVISIONE SOLMAG OLON SPA SHARON BIO MEDICINE LTD SHOUGUANG FUKANG PHARMACEUTICAL CO LTD COLORCON INC II 8/5/2011 SPI PHARMA INC STATUS Type SUBMIT DATE II 8/4/2011 HOLDER MYLAN LABORATORIES LTD SUBJECT

4Q2012

EFAVIRENZ USP(PROCESS - II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR MYLAN LABORATORIES LIMITED BULK ACTIMASK TASTE MASKED ACETAMINOPHEN AS MANUFACTURED IN GRAND HAVEN, MICHIGAN TRETINOIN TYPE 2 AS MANUFACTURED IN GARBAGNATE MILANESE (MI) - ITALY DIENOGEST AS MANUFACTURED IN RODANO (MI), ITALY MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA TRIMETHOPRIM AS MANUFACTURED IN SHOUGUANG CITY, CHINA SUPPLEMENTARY INFORMATION FOR COLORCON PRODUCT POLYVINYL ACETATE PHTHALATE (PVAP)" AS MANUFACTURED IN WEST POINT, PA BETAMETHASONE, USP (MICRONIZED) AS MANUFACTURED IN DIST. DHAR, (M.P.), INDIA LEVOLEUCOVORIN CALCIUM AS MANUFACTURED IN COUVET, SWITZERLAND 3M COTRAN 9759 DOUBLE-COATED MEDICAL TAPE AS MANUFACTURED IN BROOKINGS, SD FOR 3M DRUG DELIVERY SYSTEMS ENTECAVIR MONOHYDRATE BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG, CHINA FLUVOXAMINE MALEATE (SV-006) AS MANUFACTURED IN VISP, SWITZERLAND RISPERIDONE PROCESS II (NON STERILE, API) AS MANUFACTURED IN SHANDONG PROVINCE, P. R. OF CHINA VINORELBINE TARTRATE (PROCESS I) (NON STERILE, API) AS MANUFACTURED IN SHANDONG PROVINCE, P. R. OF CHINA MIDAZOLAM HCI AS MANUFACTURED IN VICENZA, ITALY IMATINIB MESYLATE (BETA FORM) AS MANUFACTURED IN VICENZA, ITALY IMATINIB MESYLATE (ALPHA FORM) AS MANUFACTURED IN VICENZA, ITALY

HEBEI HUARONG PHARMACEUTICAL CO LTD ACARBOSE AS MANUFACTURED IN HEBEI, CHINA EYE APPLICATOR BRUSH AS MANUFACTURED IN OMAHA, NE FOR ROY AND LECLAIR EMBALLAGE INC. NYLON MXD-6 GRADES FOR USE IN PHARMACEUTICAL PACKAGING APPLICATIONS AS MANUFACTURED IN COLONIAL HEIGHTS, VIRGINIA AND NIIGATA, JAPAN FOR MITSUBISHI GAS CHEMICAL CO., INC MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ ARACHAMIDE MEA (CODE NAME: PC-9S) AS MANUFACTURED IN DAEJEON, KOREA TYLOSIN TARTRATE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA ISOPROTERENOL HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN BOULDER, CO ACETAMINOPHEN AS MANUFACTURED IN BENGBU CITY, CHINA SULFAMETHOXAZOLE AS MANUFACTURED IN SHOUGUANG CITY, CHINA SABIC HDPE PCG300054 AS MANUFACTURED IN AI GELEEN, THE NETHERLANDS

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4Q2012EXCEL DMF# 25216 25217 A 25218 A 25219 25220 A 25221 I 25222 25223 A 25224 A 25225 25226 25227 25228 A 25229 A 25230 A 25231 25232 A 25233 A 25234 25235 A 25236 A 25237 25238 A 25239 A 25240 A 25241 25242 A A III II 8/16/2011 8/29/2011 CHEMIPACK INDIA PRIVATE LTD HANGZHOU JIUYUAN GENE ENGINEERING CO LTD II 9/19/2011 II 11/7/2011 ORCHID CHEMICALS AND PHARMACEUTICALS LTD OTSUKA AMERICA PHARMACEUTICAL INC A III II 8/23/2011 8/25/2011 II 9/16/2011 A II II 8/17/2011 8/31/2011 ROVI CONTRACT MANUFACTURING SL ORCHID CHEMICALS AND PHARMACEUTICALS LTD ORCHID CHEMICALS AND PHARMACEUTICALS LTD PRAVESHA INDUSTRIES PRIVATE LTD HETERO DRUGS LTD III 8/17/2011 TEKNOR APEX CO A II V 11/2/2011 8/23/2011 AMOLI ORGANICS PVT LTD ION BEAM APPLICATIONS SA V 6/14/2011 BIOSCAN INC II 3/7/2011 ALP PHARM BEIJING CO LTD A A A II II II II 8/16/2011 8/18/2011 8/18/2011 8/23/2011 APOTEX PHARMACHEM INDIA PVT LTD DECCAN NUTRACEUTICALS PVT LTD CHEMAGIS LTD FARMABIOS S P A II 9/16/2011 AMOLI ORGANICS PVT LTD A II II 11/9/2011 12/20/2011 SHILPA MEDICARE LTD EPAX NORWAY AS BENDAMUSTINE HCL AS MANUFACTURED IN KARNATAKA, INDIA II 8/22/2011 MATRIX PHARMA GROUP XIAMEN LTD A II IV 8/16/2011 8/19/2011 II 8/18/2011 STATUS Type SUBMIT DATE A II II 8/11/2011 8/26/2011 HOLDER ULKAR KIMYA SANAYII VE TICARET AS ORCHID CHEMICALS AND PHARMACEUTICALS LTD JOHNSON MATTHEY PHARMACEUTICAL MATERIALS PARABOLIC DRUGS LTD DAVID MICHAEL AND CO INC SUBJECT CANDESARTAN CILEXETIL AS MANUFACTURED IN TEKIRDAG, TURKEY

4Q2012

CLOPIDOGREL BISULFATE(ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA JOHNSON MATTHEY 4147.F AS MANUFACTURED IN DEVENS, MA FOR JOHNSON MATTHEY PHARMACEUTICAL MATERIALS CANDESARTAN CILEXETIL AS MANUFACTURED HARYANA, INDIA NATURAL AND ARTIFICIAL LEMON FLAVOR #11980 AS MANUFACTURED IN PHILADELPHIA, PA NEVIRAPINE ANHYDROUS USP AS MANUFACTURED IN FUJIAN PROVINCE, P. R. OF CHINA

EPAX 4608 EE US PH (EPA-ENRICHED FATTY ACID ETHYL ESTER) (ESUB) AS MANUFACTURED IN AALESUND, NORWAY DICLOFENAC EPOLAMINE/DICLOFENAC APOLAMINE (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA ALMOTRIPTAN MALATE AS MANUFACTURED IN KARNATAKA, INDIA 10-DEACETYL BACCATIN III (10-DAB III) AS MANUFACTURED IN MAHARASHTRA, INDIA OMEPRAZOLE MAGNESIUM AS MANUFACTURED IN BEER SHEVA, ISRAEL DIFLUPREDNATE (MICRONIZED) AS MANUFACTURED IN GROPELLO CAIROLI (PV), ITALY RIZATRIPTAN BENZOATE AS MANUFACTURED IN CHONGQING, CHINA FOR ALP PHARM BEIJING CO., LTD F18-PLUS SYNTHESIZER FOR PRODUCTION OF PET TRACERS AS MANUFACTURED IN YORK, PA FOR BIOSCAN, INC. SILDENAFIL CITRATE FORM-II (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA RADIO-HARMACEUTICAL SYNTHESIS MODULE SYNTHERA V2 AS MANUFACTURED LOUVAIN-LA NEUVE, BELGIUM MEDALIST MD-555 NATURAL AS MANUFACTURED IN HENDERSON, KY AND SAINT ALBANS, VT FOR TEKNOR APEX COMPANY STERILE WATER FOR INJECTION, USP, 5.0 ML AS MANUFACTURED IN MADRID, SPAIN DEXLANSOPRAZOLE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ZOLMITRIPTAN (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA MASTER BATCH/COLORANT AS MANUFACTURED IN ANDHRA PRADESH, INDIA SERTRALINE HYDROCHLORDE, USP (FORM II), PROCESS II AS MANUFACTURED IN ANDHRA PRADESH, INDIA DORIPENEM (STERILE) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA STERILE WATER FOR INJECTION USP, 2 ML VIAL (ESUB) AS MANUFACTURED IN HAMELN, GERMANY FOR OTSUKA AMERICA PHARMACEUTICAL, INC. 'HDPE BOTTLE' AS MANUFACTURED IN ANDHRA PRADESH, INDIA ENOXAPARIN SODIUM AS MANUFACTURED IN HANGZHOU, CHINA

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4Q2012EXCEL DMF# 25243 A 25244 A 25245 25246 A 25247 25248 A 25249 A 25250 A 25251 25252 25253 A 25254 A 25255 A 25256 A 25257 A 25258 A 25259 25260 25261 25262 25263 25264 A 25265 25266 25267 25268 A 25269 25270 A A II II 5/10/2011 5/23/2011 TOMITA PHARMACEUTICAL CO LTD TOMITA PHARMACEUTICAL CO LTD U.S.P. MAGNESIUM GLUCONATE AS MANUFACTURED IN TOKUSHIMA, JAPAN A A A II II II II 9/7/2011 9/7/2011 9/7/2011 4/27/2011 EUTICALS SPA EUTICALS SPA EUTICALS SPA TOMITA PHARMACEUTICAL CO LTD A A A A A II II II II II V 10/11/2011 9/24/2011 9/6/2011 9/6/2011 9/2/2011 8/31/2011 LUPIN LTD ALKEM LABORATORIES LTD HETERO DRUGS LTD HETERO LABS LTD EVERLIGHT CHEMICAL INDUSTRIAL CORP ION BEAM APPLICATIONS SA II 10/11/2011 IPCA LABORATORIES LTD II 5/3/2012 AMI ORGANICS PVT LTD II 9/1/2011 VIFOR INTERNATIONAL INC II 9/1/2011 II 8/23/2011 ZHEJIANG SUPOR PHARMACEUTICALS CO LTD NOF CORP A A II II III 9/6/2011 8/30/2011 9/1/2011 LABORCHEMIE APOLDA GMBH GUFIC BIOSCIENCES LTD VISTAPAC(HK)INDUSTRIAL LTD V 8/29/2011 II 9/1/2011 A II II 8/26/2011 9/1/2011 BIOCON LTD AVANTI POLAR LIPIDS INC A II II 8/18/2011 6/20/2011 INDOCO REMEDIES LTD TOMITA PHARMACEUTICAL CO LTD V 8/29/2011 ION BEAM APPLICATIONS SA STATUS Type SUBMIT DATE V 10/28/2011 HOLDER WYETH LEDERLE S.R.L SUBJECT

4Q2012

CATANIA NON-PENICILLIN VIALS DEPARTMENT (01) ASEPTIC FACILITY (ESUB) AS LOCATED IN CATANIA, ITALY RADIO-PHARMACEUTICAL SYNTHESIS MODULE << SYNTHERA V1 >> AS MANUFACTURED IN LOUVAIN-LA-NEUVE, BELGIUM BROMFENAC SODIUM (ESUB) AS MANUFACTURED IN MUMBAI INDIA U.S.P. MANGANESE GLUCONATE DIHYDRATE AS MANUFACTURED IN TOKUSHIMA, JAPAN ATORVASTATIN CALCIUM CRYSTALLINE AS MANUFACTURED IN BANGALORE, INDIA

1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DPPC) AS MANUFACTURED IN ALABASTER, ALABAMA NATIONAL CANCER INSTITUTE DIV CANCER RECOMBINANT HUMAN INTERLEUKIN-15 (RHIL-15) AS MANUFACTURED IN FREDERICK, TREATMENT AND DIAGNOSIS MD FOR NATIONAL CANCER INSTITUTE (NCI), DIVISIO OF CANCER TREATMENT AND DIAGNOSIS (DCTD) ION BEAM APPLICATIONS SA SYNTHERA?INTEGRATED FLUIDIC PROCESSOR AS MANUFACTURED IN LOUVAIN-LANEUVE, BELGIUM DIENOGEST AS MANUFACTURED IN THURINGIA, GERMANY PRILOCAINE USP AS MANUFACTURED IN GUJARAT, INDIA DESICCANT TYPE PACKAGING MATERIAL AS MANUFACTURED IN DONGGUAN CITY, P.R. CHINA FOR VITAPAC (HK) INDUSTRIAL LTD. BUPROPION HYDROBROMIDE AS MANUFACTURED IN ZHEJIANG, P. R. CHINA DLINDMA (1,2-DILINOLEYLOXY-N,N-DIMETHYLPROPYLAMINE AS MANUFACTURED IN HYOGO AND KANAGAWA, JAPAN CARBOXYMETHYLATED DEXTRAN (CM DEXTRAN) AS MANUFACTURED IN GALLEN, SWITZERLAND 1- (2-METHOXYPHENYL) PIPERAZINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA PRIMAQUINE PHOSPHATE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA BRIMONIDINE TARTRATE (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA RILUZOLE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA RALTEGRAVIR POTASSIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA EFAVIRENZ (PROCESS III) AS MANUFACTURED IN ANDHRA PRADESH, INDIA TRAVOPROST AS MANUFACTURED IN TAOYUAN HSIEN, TAIWAN RADIO-PHARMACEUTICAL PURIFICATION/SEPARATION MODULE SYNTHERA HPLC AS MANUFACTURED IN LOUVAIN-LA-NEUVE, BELGIUM AZACITIDINE AS MANUFACTURED IN VARESE, ITALY CAPECITABINE AS MANUFACTURED IN LODI, ITALY CYTARABINE AS MANUFACTURED IN VARESE, ITALY U.S.P. MAGNESIUM SULFATE, ANHYDROUS AS MANUFACTURED IN TOKUSHIMA, JAPAN

U.S.P. MAGNESIUM OXIDE HEAVY POWDER AS MANUFACTURED IN TOKUSHIMA, JAPAN

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4Q2012EXCEL DMF# 25271 A 25272 25273 A 25274 25275 A 25276 A 25277 A 25278 A 25279 A 25280 25281 25282 A 25283 A 25284 25285 25286 A 25287 25288 25289 25290 25291 25292 A 25293 25294 A 25295 A 25296 25297 25298 25299 25300 A A A A A II II II III II 9/12/2011 9/13/2011 9/11/2011 10/20/2011 9/13/2011 HETERO DRUGS LTD HETERO DRUGS LTD HIKMA PHARMACEUTICALS WEENER EMPIRE PLASTICS LTD DISHMAN NETHERLAND B.V. II 9/7/2011 FUJIAN SOUTH PHARMACEUTICAL CO LTD A III II 8/11/2011 9/7/2011 TRUDELL MEDICAL INTERNATIONAL FUJIAN SOUTH PHARMACEUTICAL CO LTD A A A P P III 9/7/2011 II III II 9/9/2011 9/6/2011 9/12/2011 SANOFI AVENTIS SPA ELIX POLYMERS SL CATALENT PHARMA SOLUTIONS LLC *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** ADVANCED FILMS LLC RIFAMYCIN SODIUM AS MANUFACTURED IN BRINDISI, ITALY A P II 5/9/2012 III 9/6/2011 II 8/31/2011 FIDIA FARMACEUTICI SPA DIVISIONE SOLMAG ELIX POLYMERS SL *** PENDING FILING REVIEW *** CHATTEM CHEMICALS INC A A II II II 9/12/2011 9/6/2011 9/8/2011 HETERO DRUGS LTD HETERO DRUGS LTD II 3/30/2012 III 10/6/2011 III 8/30/2011 II 9/8/2011 A II II 10/6/2011 7/25/2011 BAYER PHARMA AG A II II 2/28/2011 10/6/2011 TOMITA PHARMACEUTICAL CO LTD BAYER PHARMA AG STATUS Type SUBMIT DATE II 5/23/2011 HOLDER TOMITA PHARMACEUTICAL CO LTD SUBJECT

4Q2012

U.S.P. MAGNESIUM OXIDE HEAVY FINE GRANULAR AS MANUFACTURED IN TOKUSHIMA, JAPAN U.S.P. MAGALDRATE AS MANUFACTURED IN TOKUSHIMA, JAPAN NICLOSAMIDE ANHYDROUS DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN RUBI (BCN), SPAIN NICLOSAMIDE 500MG TABLET (ESUB) AS MANUFACTURED IN TURKU, FINLAND

SYMBIOTICA SPECIALITY INGREDIENTS SDN EXEMESTANE AS MANUFACTURED IN KEDAH, MALAYSIA BHD BAXTER HEALTHCARE CORP MESNA, USP/EP DRUG SUBSTANCE AS MANUFACTURED IN BIELEFELD AND HALLE/WESTFALEN, GERMANY FOR BAXTER HEALTHCARE CORPORATION CELGARD LLC CELGARD 2300 SERIES TRANSDERMAL FLAT SHEET MEMBRANE AS MANUFACTURED IN CHARLOTTE, NORTH CAROLINA PLASTITEC SA PVC BAGS AND ITS COMPONENTS FOR PHARMACEUTICAL SOLUTIONS (ESUB) AS MANUFACTURED IN BOGOTA, COLOMBIA JUBILANT LIFE SCIENCES LTD LEVOCETIRIZINE DIHYDROCHLORIDE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA RALOXIFENE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

PHARMACEUTICAL WORKS POLPHARMA SA DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN STAROGARD GDANSKI, POLAND OTILONIUM BROMIDE AS MANUFACTURED IN GARBAGNATE MILANESE (MI), AND DORNO (PV), ITALY ELIX ABS M205FC, VARIOUS COLORS AS MANUFACTURED IN LA CANONJA, SPAIN METHADONE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN CHATTANOOGA, TN

ELIX ABC M203FC, VARIOUS COLORS AS MANUFACTURED IN LA CANONJA, SPAIN AMR101 1G CAPSULES AS MANUFACTURED IN ST. PETERSBURG, FLORIDA

MEDICAL POUCH FILM, PRODUCT CODE F-19 AS MANUFACTURED IN RICHMOND, BC, CANADA FOR ADVANCED FILMS, LLC TOP MOUNT ACTUATION INDICATOR AS MANUFACTURED IN ONTARIO, CANADA 10-DEACETYL-BACCATIN III (10-DAB III) (NON-STERILE) AS MANUFACTURED IN FUJIAN PROVINCE, P. R. OF CHINA DOCETAXEL ANHYDROUS, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN FUJIAN PROVINCE, P. R. OF CHINA NEBIVOLOL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ZOLMITRIPTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA GRANISETRON HYDROCHLORIDE AS MANUFATURED IN AMMAN, JORDAN PLASTIC CLOSURES (ESUB) AS MANUFACTURED IN MAHARASHTRA STATE, INDIA PARICALCITOL AS MANUFACTURED IN BE VEENENDAAL, THE NETHERLANDS

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4Q2012EXCEL DMF# 25301 A 25302 25303 A 25304 A 25305 A 25306 25307 A 25308 25309 25310 25311 25312 25313 25314 25315 A 25316 25317 25318 25319 25320 25321 25322 A 25323 25324 25325 A 25326 25327 A 25328 A 25329 A 25330 A 25331 A II 9/14/2011 ASAHI KASEI FINECHEM CO LTD IV 9/21/2011 NIPPON FINE CHEMICAL CO LTD IV 9/21/2011 NIPPON FINE CHEMICAL CO LTD II 10/21/2011 DR REDDYS LABORATORIES LTD A II II 9/28/2011 9/24/2011 SANGROSE LABORATORIES PVT LTD MSN LABORATORIES LTD A A II II II 9/27/2011 9/19/2011 10/21/2011 LEK PHARMACEUTICALS DD BACHEM SA DR REDDYS LABORATORIES EU LTD A A A A A A II II II II II II V 9/22/2011 9/21/2011 9/12/2011 8/22/2011 10/25/2011 10/24/2011 12/14/2011 FINE CHEMICALS CORP PTY LTD INTAS PHARMACEUTICALS LTD MANGALAM DRUGS AND ORGANICS LTD NEWCHEM SPA SUN PHARMACEUTICAL INDUSTRIES LTD EMCURE PHARMACEUTICALS LTD CORDEN PHARMA LATINA SPA A A P A A P A II II 10/3/2011 11/23/2011 II II 11/2/2011 10/14/2011 II II 10/3/2011 9/20/2011 IND SWIFT LABORATORIES LTD CHEMO IBERICA SA *** PENDING FILING REVIEW *** AMOLI ORGANICS PVT LTD CRESTONE INC *** PENDING FILING REVIEW *** CADILA HEALTHCARE LTD APICORE LLC A II III 6/9/2011 9/12/2011 II 9/13/2011 II 9/13/2011 A II II 8/16/2011 9/15/2011 VITAL HEALTH CARE PVT LTD QILU ANTIBIOTICS PHARMACEUTICAL CO LTD SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD VITAL HEALTH CARE PVT LTD AMPACET CORP NIMESULIDE AS MANUFACTURED IN GIDC VAPI, INDIA STATUS Type SUBMIT DATE II 9/22/2011 HOLDER INDOCO REMEDIES LTD SUBJECT

4Q2012

BETAXOLOL HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA

CEFEPIME FOR INJECTION AS MANUFACTURED IN SHANDONG PROVINCE, CHINA TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN SHANGHAI, CHINA ATOVAQUONE AS MANUFACTURED IN SHANGHAI, CHINA ARTEMETHER AS MANUFACTURED IN GIDC VAPI, INDIA 412978 WHITE POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN AND DERIDDER, LA AND CARTERSVILLE, GA AND HEATH, OH ANASTROZOLE USP (ESUB) AS MANUFACTURED IN PUNJAB, INDIA RABEPRAZOLE SODIUM (PROCESS II) AS MANUFACTURED IN MADRID, SPAIN SILDENAFIL CITRATE FORM-I (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA CRS3123 (ESUB) AS MANUFACTURED IN MENLO PARK, CA FOR CRESTONE, INC. ERLOTINIB HYDROCHLORIDE (FORM-B) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA BROMFENAC SODIUM (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FOR APICORE LLC SCOPOLAMINE (HYOSCINE) AS MANUFACTURED IN CAPE TOWN, SOUTH AFRICA DECITABINE AS MANFACTURED IN STATE-GUJARAT, INDIA FUROSEMIDE USP AS MANUFACTURED IN GUJARAT, INDIA BUDESONIDE MICRONIZED AS MANUFACTURED IN VERONA, ITALY RABEPRAZOLE SODIUM (ESUB) AS MANUFACTURED IN GUJARAT, INDIA MEMANTINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ASEPTIC PENICILLIN FACILITY (ESUB) AS MANUFACTURED IN SERMONETA (LATINA), ITALY MYCOPHENOLATE MOFETIL (PROCESS B) AS MANUFACTURED IN MENGES, SLOVENIA BRINZOLAMIDE AS MANUFACTURED IN VIONNAZ, SWITZERLAND 20 KDA METHOXYPOLY(ETHYLENE GLYCOL)-4-NITROPHENYL CARBONATE (ESUB) AS MANUFACTURED IN WEST YORKSHIRE, UNITED KINGDOM CLOFAZIMINE AS MANUFACTURED IN MAVELIKARA KERALA, INDIA ALMOTRIPTAN MALATE [ROUTE CODE - AM] [NON-STERILE DRUG SUBSTANCE] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA PRASUGREL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA N-(CARBONYL-METHOXYPOLYETHYLENEGLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3PHOSPHOETHANOLAMINE,SODIUM SALT (MPEG2000-DSPE) AS MANUFACTUED IN HYOGO, JAPAN 1-STEAROYL-LYSOPHOSPHATIDYLCHOLINE (1-STEPC) AS MANUFACTURED IN HYOGO, JAPAN TRANEXAMIC ACID USP AS MANUFACTURED IN MIYAZAKI, JAPAN

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4Q2012EXCEL DMF# 25332 25333 25334 A 25335 A 25336 A 25337 A 25338 I 25339 A 25340 25341 A 25342 A 25343 25344 25345 A 25346 25347 A 25348 25349 A 25350 25351 A 25352 A 25353 A 25354 A 25355 25356 A 25357 25358 25359 A A A II II III 11/3/2011 10/6/2011 10/6/2011 USV LIMITED SMS PHARMACEUTICALS LTD AMPACET CORP A II II 10/5/2011 10/5/2011 AMI LIFE SCIENCES PRIVATE LTD MSN LABORATORIES LTD II 10/5/2011 MEGAFINE PHARMA P LTD III 10/5/2011 AMPACET CORP III 10/4/2011 NYPRO INC A III III 10/4/2011 10/4/2011 A II II 10/24/2011 10/18/2011 CADILA HEALTHCARE LTD KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE HUAYI ISOTOPES CORP NYPRO INC A II II 11/4/2011 10/5/2011 AMOLI ORGANICS PVT LTD VALDEPHARM A A II II II 10/4/2011 10/4/2011 10/14/2011 MYLAN LABORATORIES LTD HETERO LABS LTD CRESTONE INC VORICONAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA TEMOZOLOMIDE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA II 10/3/2011 CHEMPORT INC A II II 10/3/2011 10/3/2011 MEIJI SEIKA PHARMA CO LTD QUESTCOR PHARMACEUTICALS INC II 10/3/2011 II 10/3/2011 XINJIANG NUZILINE BIO PHARMACEUTICAL CO LTD ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD AIR LIQUIDE HEALTHCARE AMERICA CORP II 10/3/2011 II 10/3/2011 STATUS Type SUBMIT DATE A A IV IV II 9/16/2011 9/16/2011 10/3/2011 HOLDER SAMSUNG FINE CHEMICALS CO LTD SAMSUNG FINE CHEMICALS CO LTD ALP PHARM BEIJING CO LTD SUBJECT

4Q2012

HYPROMELLOSE PHTHALATE AS MANUFACTURED IN INCHEON, REPUBLIC OF KOREA HYPROMELLOSE AS MANUFACTURED IN INCHEON, REPUBLIC OF KOREA

LEUCOVORIN CALCIUM AS MANUFACTURED IN ZHEJIANG, CHINA FOR ALP PHARM BEIJING CO., LTD. CENTAUR PHARMACEUTICALS PRIVATE LTD CHLORDIAZEPOXIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA ZHEJIANG HISUN PHARMACEUTICAL CO LTD MYCOPHENOLATE MOFETIL AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA CONJUGATED ESTROGENS AS MANUFACTURED IN XINJIANG PROVINCE, CHINA

800 PPM NITROGEN DIOXIDE BALANCE AIR AS MANUFACTURED IN PLUMSTEADVILLE, PA ARBEKACIN SULFATE DRUG SUBSTANCE AS MANUFACTURED IN IWATE, JAPAN H.P. ACTHAR GEL (REPOSITORY CORTICOTROPIN INJECTION) AS MANUFACTURED IN BALTIMORE, MD FOR QUESTCOR PHARMACEUTICALS, INC OMEGA-3-ACID ETHYL ESTERS AS MANUFACTURED IN JEOLLANAM-DO, SOUTH KOREA

CRS3123-2HCL (ESUB) AS MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE FOR CRESTONE, INC ATORVASTATIN CALCIUM (ESUB) AS MANUFACTURED IN GUJARAT STATE, INIDA STERILE ARIPIPRAZOLE MONOHYDRATE AS MANUFACTURED IN VAL DE REUIL, FRANCE DESVENLAFAXINE BASE (ESUB) AS MANUFACTURED IN STATE: GUJARAT, INDIA DISINTEQUIK ODT AS MANUFACTUED IN NORWICH, NY MX CASSETTES AS MANUFACTURED IN JIANGSU PROVINCE, CHINA MDI ACTUATOR/ DOSE COUNTER ASSEMBLY AS MANUFACTURED IN COUNTY DUBLIN, IRELAND FOR NYPRO INC CONCEPT ONE DRY POWDER INHALER AS MANUFACTURED IN FONTENAY SUR EURE, FRANCE FOR NYPRO INC 112761 WHITE PE MB AS MANUFACTURED IN TERRE HAUTE, IN; CARTERSVILLE, GA; HEATH, OH; DERIDDER ,LA BOSENTAN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN DIST. NASHIK, INDIA TADALAFIL AS MANUFACTURED IN STATE GUJARAT, INDIA AZELASTINE HYDROCHLORIDE [ROUTE CODE: AH] AS MANUFACTURED IN ANDHRA PRADESH, INDIA SEVELAMER CARBONATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA SILDENAFIL CITRATE (UNIT-II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA 169240 BLUE/HR POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA; HEATH, OH

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4Q2012EXCEL DMF# 25360 25361 25362 25363 A 25364 A 25365 25366 A 25367 A 25368 A 25369 25370 25371 A 25372 25373 25374 25375 A 25376 A 25377 A 25378 A 25379 A 25380 A 25381 A 25382 A 25383 A 25384 A 25385 A II 10/14/2011 III 4/30/2012 SHRINIWAS CONTAINERS AND CLOSURES PVT LTD CHEMI SPA III 10/13/2011 II 10/13/2011 II 10/13/2011 CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTD DISHMAN PHARMACEUTICALS AND CHEMICALS LTD TEKNOR COLOR CO II 10/13/2011 IV 10/12/2011 II 10/12/2011 IV 10/12/2011 III 10/12/2011 AMPACET CORP A A A II II III III 10/11/2011 10/11/2011 10/11/2011 2/10/2012 SANDOZ PRIVATE LTD ALEMBIC PHARMACEUTICALS LTD INDIAN EXTRUSIONS RADPHARM SCIENTIFIC, A DIVISION OF GLOBAL MEDICAL SOLUTIONS A A IV II II 9/30/2011 10/3/2011 10/11/2011 UNGERER AND CO IBA MOLECULAR NORTH AMERICA INC GE HEALTHCARE INC II 10/3/2011 ALP PHARM BEIJING CO LTD II 10/28/2011 MALLINCKRODT INC A II II 10/7/2011 10/7/2011 ALEMBIC PHARMACEUTICALS LTD MAPRIMED SA NISOLDIPINE AS MANUFACTURED IN GUJARAT, INDIA II 10/7/2011 STATUS Type SUBMIT DATE A A A II II II II 10/6/2011 11/16/2011 10/25/2011 10/6/2011 HOLDER LABORATORIOS IMPERIALES SA DE CV UNIMARK REMEDIES LTD UNIMARK REMEDIES LTD SCI PHARMTECH INC SUBJECT BISMUTH SUBSALICYLATE AS MANUFACTURED IN MORELOS, MEXICO

4Q2012

BUSPIRONE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA MOXIFLOXACIN HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA

(+)-THREO-PHENYL-2-PIPERIDIN-2-YL-ACETIC ACID. HCI (5TC) AS MANUFACTURED IN TAOYUAN, TAIWAN CENTAUR PHARMACEUTICALS PRIVATE LTD TEMAZEPAM USP AS MANUFACTURED IN MAHARASHTRA, INDIA

RASAGILINE MESYLATE (CODE 50855) AS MANUFACTURED IN BUENOS AIRES, ARGENTINA PARACETAMOL DC 272N (GELATIN) (ESUB) AS MANUFACTURED IN GREENVILE, ILLINOIS MOXIFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA FOR ALP PHARM BEIJING CO., LTD. ARTIFICIAL ROSE FLAVOR FU-6326 AS MANUFACTURED IN BETHLEHEM, PA 3'-DEOXY-3'-[18F]FLUOROTHYMIDINE AS MANUFACTURED IN TOTOWA, NJ FASTLAB FDG CITRATE CASSETTE PACK AS MANUFACTURED IN LIEGE, BELGIUM FOR GE HEALTHCARE INC DORIPENEM MONOHYDRATE, STERILE AS MANUFACTURED IN MAHARASHTRA, INDIA FELODIPINE USP AS MANUFACTURED IN GUJARAT, INDIA HDPE BOTTLES WITH CAPS AS MANUFACTURED IN DAMAN, INDIA RADPHARM GAMMA STERILIZED EMPTY VIALS 10ML, 20ML AND 30ML(ESUB) AS MANUFACTURED IN BELCONNEN, AUSTRALIA FOR RADPHARM SCIENTIFIC, A DIVISION OF GLOBAL MEDICAL SOLUTIONS

154313 RED PE MB AS MANUFACTURED IN GRAND DUCHE DE, LUXEMBOURG FOR AMPACET CORPORATION ABELEI INC PRODUCT #174A95 NAT. & ART. MINT FLAVOR POWDER AS MANUFACTURED IN NORTH AURORA, IL QILU PHARMACEUTICAL CO LTD ROPIVACAINE HYDROCHLORIDE (NON STERILE, API) AS MANUFACTURED IN SHANDONG PROVINCE, P. R. OF CHINA MEXICHEM UK LTD INHALATION GRADE 1,1,1,2,3,3,3-HEPTAFLUOROPROPANE FOR USE IN METERED DOSE INHALERS AS MANUFACTURED IN EL DORADO, AR FOR MEXICHEM UK LTD CENTAUR PHARMACEUTICALS PRIVATE LTD NORTRIPTYLINE HCI USP AS MANUFACTURED IN MAHARASHTRA, INDIA CEFTRIAXONE SODIUM STERILE AS MANUFACTURED IN HEBEI PROVINCE, THE P. R. OF CHINA CHOLESTEROL HP AS MANUFACTURED IN GUJARAT, INDIA 040,121TCS FDA TR BLUE 2% AS MANUFACTURED IN HENDERSONK, KY AND JACKSONVILLE, TX HIGH PERFORMANCE BOTTLES (ESUB) MESALAMINE CRYSTALLIZED, USP AS MANUFACTURED IN FROSINONE, ITALY

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4Q2012EXCEL DMF# 25386 A 25387 25388 25389 25390 A 25391 A 25392 25393 25394 25395 25396 A 25397 25398 25399 A 25400 A 25401 25402 A 25403 A 25404 25405 A 25406 A 25407 A 25408 A 25409 A 25410 25411 A 25412 A 25413 A IV 10/24/2011 II 10/24/2011 ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD TAKASAGO INTERNATIONAL CORP A II II 10/24/2011 10/24/2011 MACLEODS PHARMACEUTICALS LTD HETERO LABS LTD III 10/21/2011 LUCAS PACKAGING GROUP IV 10/21/2011 FMC CORP FMC BIOPOLYMER DIV III 10/21/2011 II 10/21/2011 I II II 10/20/2011 10/20/2011 JOYANG LABORATORIES IV 8/1/2011 BHARAT COATS A II II 11/4/2011 10/20/2011 GLAND PHARMA LTD MEGAFINE PHARMA P LTD II 11/3/2011 GLAND PHARMA LTD A A IV IV II 10/18/2011 10/18/2011 11/7/2011 UNGERER AND CO UNGERER AND CO GLAND CHEMICALS PRIVATE LTD A A A A III II II IV III 10/17/2011 10/18/2011 10/18/2011 10/18/2011 10/18/2011 UPM RAFLATAC OY EUTICALS SPA EUTICALS SPA UNGERER AND CO AMPACET CORP V 10/17/2011 A A A II III II II 10/14/2011 12/2/2011 10/17/2011 10/17/2011 FRESENIUS KABI ANTI INFECTIVES SRL WOLFE TORY MEDICAL, INC. PIRAMAL HEALTHCARE LTD CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTD MEDISIZE CORP STATUS Type SUBMIT DATE III 10/14/2011 HOLDER 3M DRUG DELIVERY SYSTEMS SUBJECT

4Q2012

SOLID MICROSTRUCTURED TRANSDERMAL SYSTEM (SMTS) ARRAY FOR BA058-SMTS AS MANUFACTURED IN ST. PAUL, MN AND FLORENCE, KY FOR 3M DRUG DELIVERY SYSTEMS BUFFERED NAFCILLIN SODIUM STERILE AS MANUFACTURED IN VILLADOSE (RO), ITALY VAXINATOR ATOMIZATION TIP AS MANUFACTURED IN SALT LAKE CITY, UT ACYCLOVIR AS MANUFACTURED IN ANDHRA PRADESH, INDIA CEFIXIME NON-STERILE AS MANUFACTURED IN HEBEI PROVINCE, CHINA INSERTER FOR LNG IUS 13.5 MG AS MANUFACTURED IN LEHMO, FINLAND FOR MEDISIZE CORPORATION RP 31 PURUS AS MANUFACTURED IN TAMPERE, FINLAND BUSULFAN AS MANUFACTURED IN VARESE, ITALY BENDAMUSTINE HYDROCHLORIDE HYDRATE AS MANUFACTURED IN VARESE, ITALY N/A FRUIT TOPNOTE FLAVOR FU-6558 AS MANUFACTURED IN BETHLEHEM, PA 183538 BROWN PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA AND HEATH, OH NATURAL ORANGE WONF FLAVOR FU-6556 AS MANUFACTURED IN BETHLEHEM, PA N/A CREAM FLAVOR FU-6557 AS MANUFACTURED IN BETHLEHEM, PA PEMETREXED DISODIUM 2.5 HYDRATE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA ARGATROBAN MONOHYDRATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA INDOMETHACIN SODIUM USP (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA MEMANTINE HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN DIST. NASHIK, INDIA PROTECTAB EC-1, PROTECTAB HP-1(ORGANIC), PROTECTAB HP-1 (AQUEOUS) AND PROTECTAB MB-1 AS MANUFACTURED IN TAMILNADU, INDIA BACITRACIN USP AS MANUFACTURED IN JIANGSU, CHINA

CHANGZHOU RUIMING PHARMACEUTICAL FELODIPINE AS MANUFACTURED IN JIANGSU, CHINA CO LTD JINAN JINDA PHARMACEUTICAL CHEMISTRY CIDOFOVIR DIHYDRATE AS MANUFACTURED IN SHANDONG, CHINA CO LTD NOVAPET SA NOVAPET CR POLYESTER RESIN AS MANUFACTURED IN BARBASTRO(HUESCA), SPAIN ALUBRA SODIUM STEARYL FUMARATE AS MANUFACTURED IN QUAKERTOWN, PA AND DIST. RAIGAD, INDIA FOR FMC CORPORATION AIRLESS METERED DOSE (AMD) PEN AS MANUFACTURED IN REEDSVILLE, PA FOR LUCAS PACKAGING GROUP ENTACAPONE AS MANUFACTURED IN GUJARAT, INDIA HYDRALAZINE HYDROCHLORIDE, USP (PARENTERAL GRADE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA NILOTINIB HYDROCHLORIDE MONOHYDRATE (VERSION NO.: 1) AS MANUFACTURED IN ZHEJIANG, CHINA TAK-100176 MICRON? NATURAL ORANGE FLAVOR WONF AS MANUFACTURED IN TETERBORO, NJ

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4Q2012EXCEL DMF# 25414 A 25415 A 25416 25417 A 25418 25419 25420 A 25421 25422 25423 A 25424 A 25425 25426 A 25427 25428 A 25429 A 25430 A 25431 25432 A 25433 25434 25435 25436 A 25437 25438 25439 25440 25441 A 25442 25443 A P II 11/28/2011 *** PENDING FILING REVIEW *** ORCHID CHEMICALS AND PHARMACEUTICALS LTD A A A A III IV III II III 10/31/2011 10/31/2011 10/31/2011 10/31/2011 10/31/2011 SIBO G DOO SEPPIC SA BRUNA SEALS LLC MAC CHEM PRODUCTS INDIA PVT LTD ESSEL PROPACK LTD A A A II II II II 12/29/2011 12/31/2011 12/6/2011 10/31/2011 EMCURE PHARMACEUTICALS LTD SUN PHARMACEUTICAL INDUSTRIES LTD RELIANCE LIFE SCIENCES PVT LTD AVANTI POLAR LIPIDS INC A III III 10/28/2011 9/22/2011 POLYCINE GMBH EXTRAL SA DE CV IV 10/28/2011 ABELEI INC IV 10/28/2011 ABELEI INC A II V 1/3/2012 10/26/2011 AMOLI ORGANICS PVT LTD WEST PHARMACEUTICAL SERVICES INC A II II 11/28/2011 10/28/2011 DR REDDYS LABORATORIES LTD HETERO DRUGS LTD II 11/3/2011 AUROBINDO PHARMA LTD A A II IV III 3/1/2012 10/26/2011 10/26/2011 EXCELLA GMBH FONA INTERNATIONAL INC TEKNOR COLOR CO A P II 11/22/2011 II 10/26/2011 SYMED LABS LTD *** PENDING FILING REVIEW *** OCEAN NUTRITION CANADA LTD A IV II 10/25/2011 10/26/2011 IDEAL CURES PVT LTD LAB EXPRESS INTERNATIONAL INC IV 10/24/2011 TAKASAGO INTERNATIONAL CORP STATUS Type SUBMIT DATE IV 10/24/2011 HOLDER TAKASAGO INTERNATIONAL CORP SUBJECT

4Q2012

TAK-081662 MICRON? NATURAL & ARTIFICIAL COOL PEPPERMINT FLAVOR AS MANUFACTURED IN TETERBORO, NJ TAK-100094 MICRON? NATURAL & ARTIFICIAL CITRUS FLAVOR AS MANUFACTURED IN TETERBORO, NJ ESPHERES NEUTRAL PELLETS AS MANUFACTURED IN JAMMU & KASHMIR, INDIA CHLORHEXIDINE GLUCONATE SOLUTION USP 20% AS MANUFACTURED IN FAIRFIELD, NJ MECLIZINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA HIGH EPA INTERMEDIATE FISH OIL (ESUB) AS MANUFACTURED IN NOVA SCOTIA, CANADA DEFEROXAMINE MESYLATE USP(ESUB) AS MANUFACTURED IN FEUCHT, GERMANY 815.0020U BUBBLEGUM FLAVOR, NAT & ART AS MANUFACTURED IN GENEVA, IL 43,777HCP BLUE 25:1 AS MANUFACTURED IN HENDERSON, KY AND JACKSONVILLE, TX SILDENAFIL CITRATE (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA LINEZOLID (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA SERTRALINE HYDROCHLORIDE, USP (FORM 1) AS MANUFACTURED IN ANDHRA PRADESH, INDIA CELECOXIB (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA WESTAR READY-TO-USE (RU) GAMMA IRRADIATED ELASTOMERS AS MANUFACTURED IN JERSEY SHORE, PA FOR WEST PHARMACEUTICAL SERVICES, INC 113A68 NATURAL & ARTIFICIAL BERRY TYPE FLAVOR POWDER AS MANUFACTURED IN NORTH AURORA, IL 144A147 NATURAL & ARTIFICIAL TROPICAL TYPE FLAVOR POWDER AS MANUFACTURED IN NORTH AURORA, IL APP147 AS MANUFACTURED IN SCHIFFWEILER, GERMANY ALUMINUM BARRIER LAMINATION (ABL) AND PLASTIC BARRIER LAMINATION (PBL) IMPRESSION AS MANUFACTURED IN ESTADO DE MEXICO, MEXICO BUSULFAN USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA SEVELAMER HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA LOTEPREDNOL ETABONATE (ESUB) AS MANUFACTURED IN NAVI MUMBAI, INIDA 1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE, PROCESS II (DSPC II) AS MANUFACTURED IN ALABASTER, ALABAMA CONTAINERS SIBO AS MANUFACTURED IN SKOFJA LOKA, SLOVENIA MONTANE 20 PPI AS MANUFACTURED IN CASTRES CEDEX, FRANCE FOR SEPPIC S. A. CLOSURE LINERS AS MANUFACTURED IN MIAMI, FLORIDA SUCCINYLCHOLINE CHLORIDE USP AS MANUFACTURED IN DISTRICT THANE, INDIA LAMINATED TUBES (MURBAD UNIT) AS MANUFACTURED IN DIST. THANE MAHARASHTRA, INDIA CEFEPIME HCI USP (ESUB) AS MANUFACTURED IN KANCHEEPURAM DISTRICT, INDIA

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4Q2012EXCEL DMF# 25444 25445 25446 25447 25448 25449 A 25450 I 25451 A 25452 A 25453 A 25454 25455 A 25456 25457 A 25458 25459 A 25460 25461 25462 A 25463 A 25464 A 25465 25466 25467 25468 25469 25470 A 25471 25472 25473 A 25474 A II 11/8/2011 FINORGA SAS A A III II III 3/22/2012 1/10/2012 11/10/2011 PADMA POLYTEX INDIA PVT LTD MACLEODS PHARMACEUTICALS LTD METALCO S.R.L. A A A A A II II II II II II 11/4/2011 11/4/2011 11/4/2011 11/4/2011 11/4/2011 11/29/2011 II 11/4/2011 IV 11/4/2011 A A II II II 11/16/2011 10/20/2011 12/14/2011 A III IV 11/3/2011 11/3/2011 GIL PLASTIC PRODUCTS LTD A II II 11/3/2011 11/3/2011 A II II 12/16/2011 11/3/2011 III 11/2/2011 III 11/2/2011 III 11/2/2011 V 11/1/2011 STATUS Type SUBMIT DATE P P A A A II II II IV 11/14/2011 2/8/2012 11/2/2011 11/2/2011 HOLDER *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** CADILA HEALTHCARE LTD CADILA HEALTHCARE LTD SYMBIOTEC PHARMALAB LTD IRBESARTAN USP (ESUB) AS MANUFACTURED IN STATE: GUJARAT, INDIA DESVENLAFAXINE SUCCINATE AS MANUFACTURED IN GUJARAT, INDIA SUBJECT

4Q2012

MOMETASONE FUROATE MONOHYDRATE AS MANUFACTURED IN INDORE (M.P.), INDIA

CELANESE EVA PERFORMANCE POLYMERS ETHYLENE VINYL ACETATE COPOLYMER, ATEVA? K2356.XO1 AS MANUFACTURED IN ALBERTA, CANADA ROTEM INDUSTRIES LTD DISPOSABLE CASSETTE FOR VIAL FILLER SYSTEM AS MANUFACTURED IN BEER-SHEVA, ISRAEL AMPACET CORP 100665 MOLD RELEASE PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA AND HEALTH, OH AMPACET CORP 122103 SILVER PEARL PE MB AS MANFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA AND HEALTH, OH AMPACET CORP 169617 PEARL VIOLET PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA AND HEALTH , OH CHEMSPEC API MENADIOL SODIUM DIPHOSPHATE (ESUB) AS MANUFACTURED IN FAIRFIELD, NJ ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD VASUDHA PHARMA CHEM LTD BIOPHORE PHARMA INC CANDESARTAN CILEXETIL AS MANUFACTURED IN ZHEJIANG PROVINCE, P. R. OF CHINA CYPROHEPTADINE HCL AS MANUFACTURED IN ANDHRA PRADESH, INDIA PENTETIC ACID AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE PHARMA INC PLASTIC JARS AND BOTTLES AS MANUFACTURED IN ASHDOD, ISRAEL

CELANESE EVA PERFORMANCE POLYMERS ETHYLENE VINYL ACETATE COPOLYMER, ATEVA+F25369 K2357.X01 AS MANUFACTURED IN ALBERTA, CANADA JUBILANT HOLLISTERSTIER LLC STERILE EMPTY VIALS (ESUB) AS MANUFACTURED IN SPOKANE, WA CHENG FONG CHEMICAL CO LTD PAR PHARMACEUTICAL INC PROCAINAMIDE HYDROCHLORIDE AS MANUFACTURED IN TAOYUAN COUNTY, TAIWAN PIMOZIDE USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA FOR PAR PHARMACEUTICAL, INC CELANESE EVA PERFORMANCE POLYMERS ETHYLENE VINYL ACETATE COPOLYMER, VITALDOSE K2418.X01 AS MANUFACTURED IN ALBERTA, CANADA ZHEJIANG APELOA JIAYUAN CLOPIDOGREL BISULFATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA PHARMACEUTICAL CO LTD KEKULE PHARMA LTD NILUTAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA SYN TECH CHEM AND PHARM CO LTD EXEMED PHARMACEUTICALS HUAYI ISOTOPES CO HUAYI ISOTOPES CO ARCH PHARMALABS LTD TOLPERISONE HYDROCHLORIDE AS MANUFACTURED IN TAINAN CITY, TAIWAN METFORMIN HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA RK-100 AS MANUFACTURED IN JIANGSU PROVINCE, CHINA OXYGEN-18 WATER AS MANUFACTURED IN JIANGSU PROVINCE, CHINA CLOPIDOGREL CAMPHOR SULPHONATE SALT (ESUB) AS MANUFACTURED IN HARYANA, INDIA FOR ARCH PHARMALABS LIMITED PLASTIC POUCHES (POLY BAGS) (ESUB) AS MANUFACTURED IN UJJAIN,(M.P.) INDIA ARIPIPRAZOLE (ESUB) AS MANUFACTURED IN GUJRAT, INDIA ALUMINUM CONTAINERS FOR BULK DRUGS SUBSTANCES AS MANUFACTURED IN MONTECARLO (LU), ITALY FENOFIBRATE AS MANUFACTURED IN MOURENX, FRANCE

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4Q2012EXCEL DMF# 25475 25476 A 25477 A 25478 A 25479 25480 25481 25482 25483 C 25484 25485 25486 A 25487 A 25488 25489 A 25490 A 25491 25492 25493 25494 25495 25496 A 25497 25498 25499 A 25500 25501 A 25502 A 25503 25504 A A II II 12/20/2011 6/3/2011 ALEMBIC PHARMACEUTICALS LTD SANOFI AVENTIS DEUTSCHLAND GMBH III 11/14/2011 CONSOLIDATED BOTTLE CORP A III II 11/14/2011 11/14/2011 A A II II II 12/22/2011 11/14/2011 11/14/2011 CHEMSPEC-API GLOCHEM INDUSTRIES LTD HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD FABRI PLAST SA SUNBIO, INC. A A A A A II II II II II II 12/8/2011 11/14/2011 11/14/2011 11/14/2011 11/14/2011 1/3/2012 SHILPA MEDICARE LTD APOTEX PHARMACHEM INDIA PVT LTD APOTEX PHARMACHEM INDIA PVT LTD APOTEX PHARMACHEM INDIA PVT LTD INTAS PHARMACEUTICALS LTD PFIZER INC II 11/9/2011 AVANTI POLAR LIPIDS INC I II III 12/23/2011 11/9/2011 PHF SA JIANGSU CHAOHUA GLASSWORK CO LTD III 11/9/2011 JIANGSU CHAOHUA GLASSWORK CO LTD A A II III II 12/6/2011 11/9/2011 11/9/2011 EMCURE PHARMACEUTICALS LTD PG FOILS LTD TOYOX CO LTD A A A A II III II II II 11/4/2011 11/10/2011 11/10/2011 11/9/2011 11/9/2011 MEISSNER FILTRATION PRODUCTS INC AURIGA POLYMERS INC DERIVADOS QUIMICOS SA HETERO LABS LTD TEVA PHARMACEUTICAL INDUSTRIES LTD II 11/10/2011 ICROM SPA II 11/10/2011 FRESENIUS KABI ANTI INFECTIVES SRL STATUS Type SUBMIT DATE A IV III 11/7/2011 11/10/2011 HOLDER PHOSPHOLIPID GMBH FUJIMORI KOGYO CO LTD SUBJECT PHOSAL+F25451 35 SB AS MANUFACTURED IN COLOGNE, GERMANY

4Q2012

RELEASE LINER FILM FOR USE IN TRANSDERMAL DRUG DELIVERY PATCHES ** E-0010 GT AS MANUFACTURED IN SHIZUOKA PREF., JAPAN AMPICILLIN SODIUM/SULBACTAM SODIUM AS MANUFACTURED IN VILLADOSE (RO), ITALY BRINZOLAMIDE (MICRONIZED AND NON MICRONIZED, STERILE AND NON STERILE) AS MANUFACTURED IN CONCOREZZO, ITALY FLUOROFLEX BIOCONTAINERS AS MANUFACTURED IN CAMARILLO, CA POLYETHYLENE TEREPHTHALATE RESINS, SPARTANBURG, SC DIOXANONE AS MANUFATURED IN MURCIA (SPAIN) BORTEZOMIB (FORM-II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA IRBESARTAN (ESUB) AS MANUFACTURED IN MALANPUR AND GAJRAULA, INDIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD. ANASTROZOLE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA PRIMARY PACKAGING MATERIAL AS MANUFACTURED IN RAJASTHAN, INDIA TOYOX SILICONE HOSE SERIES AS MANUFACTURED IN TOYAMA-PREF., JAPAN FOR TOYOX COMPANY LTD. CONTAINERS FOR PARENTERAL PREPARATIONS MADE OF NEUTRAL-BOROSILICATE GLASS (TYPE I, USP) TUBING, DANYANG CITY, P.R. CHINA SOLIFENACIN SUCCINATE (ESUB) AS MANUFACTURED IN VICENZA, ITALY FOR PHF SA CONTAINERS FOR PARENTERAL PREPARATIONS MADE OF LOW-BOROSILICATE GLASS TUBING ( TYPEI, USP) DANYANG CITY, P.R CHINA 1,2-DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOCHOLINE, PROCESS II (DMPC II) AS MANUFACTURED IN ALABASTER, AL BUSULFAN USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA LINEZOLID AS MANUFACTURED IN BANGALORE, INDIA LANSOPRAZOLE USP AS MANUFACTURED IN BANGALORE, INDIA OLMESARTAN MEDOXOMIL AS MANUFACTURED IN BANGALORE, INDIA DOCETAXEL ANHYDROUS(ESUB) AS MANUFACTURED IN GUJARAT, INDIA SPIRONOLACTONE USP (ESUB) AS MANUFACTURED IN NORTHUMBERLAND, ENGLAND FOR PFIZER INC ISOCARBOXAZID (ESUB) AS MANUFACTURED IN FAIRFIELD, NJ LEVODOPA AS MANUFACTURED IN ANDHRA PRADESH, INDIA PANTOPRAZOLE SODIUM AS MANUFACTURED IN HANGZHOU, CHINA BOTE 1500ML HDPE/BO-TE US AS MANUFACTURED IN BARCELONA, SPAIN METHOXY POLYETHYLENE GLYCOL BENZOTRIAZOLYL CARBONATE 20,000 AS MANUFACTURED IN ANYANG CITY, S. KOREA 1" X 2" NATURAL PP VIAL PRINTED WITH LINE - BLUE" AS MANUFACTURED IN ONTARIO, CANADA FOR CONSOLIDATED BOTTLE CORPORATION ZOLMITRIPTAN (ESUB) AS MANUFACTURED IN GUJARAT, INDIA PREDNICARBATE AS MANUFACTURED IN FRANKFURT AM MAIN, GERMANY

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4Q2012EXCEL DMF# 25505 A 25506 A 25507 25508 A 25509 25510 25511 A 25512 A 25513 A 25514 25515 A 25516 25517 A 25518 25519 25520 A 25521 A 25522 25523 25524 A 25525 25526 25527 25528 25529 25530 25531 A 25532 25533 A 25534 A II 11/30/2011 A II II 12/16/2011 11/30/2011 FRESENIUS KABI ONCOLOGY LTD ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD SYMBIOTEC PHARMALAB LTD DECITABINE (ESUB) AS MANUFACTURED IN WEST BENGAL, INDIA METAXALONE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA TESTOSTERONE UNDECANOATE AS MANUFACTURED IN (M.P.), INDIA A A A P P A II II 12/8/2011 5/14/2012 II II II 11/28/2011 11/28/2011 11/28/2011 A A III II II 11/23/2011 11/28/2011 11/28/2011 AMERICHEM INC ICROM SPA CHONGQING HUAPONT PHARMACEUTICAL CO LTD PHYTON BIOTECH LLC FRESENIUS KABI ANTI INFECTIVES SRL ALEMBIC PHARMACEUTICALS LTD *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** TORRENT PHARMACEUTICALS LTD CHENGDU SHENGNUO BIOPHARM CO LTD II 11/23/2011 JIANGSU HENGRUI MEDICINE CO LTD A A III II V 11/22/2011 11/23/2011 3/25/2011 CHROMA CORP WUXI JIDA PHARMACEUTICAL CO LTD IONISOS IBERICA A III II 11/22/2011 12/6/2011 HBR PACKAGING AUROBINDO PHARMA LTD A II III 11/22/2011 11/22/2011 SMS PHARMACEUTICALS LTD AGUA FARMA PLASTICOS SA DE CV II 11/22/2011 II 11/21/2011 HERAEUS PRECIOUS METALS GMBH AND CO KG MSN ORGANICS PVT LTD A A II II II 11/18/2011 11/18/2011 11/18/2011 ZHUHAI RUNDU PHARMACEUTICAL CO LTD ZHUHAI RUNDU PHARMACEUTICAL CO LTD JIANGSU HENGRUI MEDICINE CO LTD A II II 11/18/2011 11/18/2011 II 11/17/2011 DISHMAN PHARMACEUTICALS AND CHEMICALS LIMITED SIEGFRIED USA LLC ICEUTICA OPERATIONS LLC STATUS Type SUBMIT DATE II 11/16/2011 HOLDER BD BIOSCIENCES ADVANCED BIOPROCESSING SUBJECT

4Q2012

BD RECHARGE WITHOUT GLUCOSE AND L-GLUTAMINE AS MANUFACTURED IN MIAMI, FL; SPARKS, MD AND SARANAC LAKE, NY FOR BD BIOSCIENCE ADVANCED BIOPROCESSING ROPIVACAINE HYDROCHLORIDE MONOHYDRATE, AHMEDABAD, GUJARAT, INDIA BUPRENORPHINE HYDROCHLORIDE, PENNSVILLE, NEW JERSEY MELOXICAM SOLUMATRIX TM CAPSULES (6 MG), AS MANUFACTURED IN KANSAS CITY, MO FOR ICEUTICA OPERATIONS LLC IRBESARTAN, GUANGDONG PROVINCE, PEOPLE'S REPUBLIC OF CHINA VALSARTAN, GUANGDONG PROVINCE, PEOPLE'S REPUBLIC OF CHINA CISATRACURIUM BESYLATE, NON-STERILE, BULK DRUG SUBSTANCE, JIANGSU PROVINCEM, CHINA BENDAMUSTINE HYDROCHLORIDE, HANAU, GERMANY TADALAFIL [ROUTE CODE - "TD"] [NON-STERILE DRUG SUBSTANCE] AS MANUFACTURED IN ANDHRA PRADESH, INDIA ITRACONAZOLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA HDPE & LDPE BOTTLES AS MANUFACTURED IN JALISCO, MEXICO FOR AGUA FARMA PLASTICOS, S.A DE C.V. ALUMINIUM VIAL SEALS AS MANUFACTURED IN THANE, INDIA ATAZANAVIR SULFATE (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA PC57088 PURPLE COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, ILLINOIS ESCITALOPRAM OXALATE AS MANUFACUTED IN JIANGSU PROVINCE, CHINA FACILITY AND PROCEDURES FOR ELECTRON BEAM STERILIZATION IN TARANCON, SPAIN CAPECITABINE USP, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU, CHINA 61936-CD2 TAN COLORANT AS MANUFACTURED IN CUYAHOGA FALLS, OH AMISULPRIDE AS MANUFACTURED IN CONCOREZZO, ITALY BENDAMUSTINE HCL, CHONGQING , P.R. CHINA PACLITAXEL PRODUCED BY PLANT CELL FERMENTATION USP, SAN ANTONIO, TX BUFFERED PENICILLIN G POTASSIUM STERILE, CERNUSCO SUL NAVIGILIO, ITALY O-DESMETHYL VENLAFAXINE, GUJARAT, INDIA

DARIFENACIN HYDROBROMIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA BIVALIRUDIN (NON-STERILE BULK DRUG) (ESUB) AS MANUFACTURED IN SICHUAN, CHINA

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4Q2012EXCEL DMF# 25535 25536 25537 25538 25539 25540 25541 25542 A 25543 25544 25545 A 25546 25547 25548 25549 25550 25551 A 25552 A 25553 25554 A 25555 A 25556 A 25557 25558 A 25559 25560 25561 A 25562 A 25563 25564 A 25565 A II 12/6/2011 A II II 12/9/2011 12/8/2011 GLOCHEM INDUSTRIES LTD KOTHARI PHYTOCHEMICALS INTERNATIONAL COPPERHEAD INVESTMENTS INC IV 9/4/2012 NECTAR LIFESCIENCES LTD A A II II II 3/15/2012 12/22/2011 5/2/2012 RELIANCE LIFE SCIENCES PVT LTD ALCHYMARS ICM SM PRIVATE LTD NECTAR LIFESCIENCES LTD A II III 12/6/2011 12/7/2011 SHARON BIO MEDICINE LTD BORMIOLI ROCCO SPA BU PLASTICS NIFEDIPINE USP AS MANUFACTURED IN NAVI MUMBAI, INDIA "PACKAGING MATERIAL" FOR DROPPER 1.00 MM AS MANUFACTURED IN CASTELGUELFO(PR),RIVANAZZANO, ITALY, SAINT SULPICE, FRANCE PEMETREXED DISODIUM (ESUB) AS MANUFACTURED IN NAVI MUMBAI, INDIA SODIUM PHENYLBUTYRATE AS MANUFACTURED IN TAMILNADU, INDIA II 12/27/2011 GLAND PHARMA LTD III 12/5/2011 A IV III 12/5/2011 12/5/2011 II 12/5/2011 ZHEJIANG TIANYU PHARMACEUTICAL CO LTD LIPOID GMBH SUZHOU HAISHUN PACKAGING MATERIAL CO LTD HANGZHOU PLASTICS INDUSTRIAL CO LTD A A A A A II II II II II V 12/1/2011 12/2/2011 12/2/2011 12/2/2011 12/2/2011 12/2/2011 LG LIFE SCIENCES LTD SYMBIOTEC PHARMALAB LTD ALPHORA RESEARCH INC SCINOPHARM TAIWAN LTD HETERO LABS LTD ROTEM INDUSTRIES LTD A A II II II 12/1/2011 12/1/2011 12/1/2011 NEULAND LABORATORIES LTD HIKMA PHARMACEUTICALS PLC FRESENIUS KABI ANTIINFECTIVES SRL EZETIMIBE AS MANUFACTURED IN ANDHRA PRADESH, INDIA MILRINONE, USP AS MANUFACTURED IN AMMAN, JORDAN PIPERACILLIN SODIUM/ TAZOBACTAM SODIUM (8:1) STERILE LYOPHILIZED AS MANUFACTURED IN CERNUSCO SUL NAVIGLIO, ITALY MONTELUKAST SODIUM AS MANUFACTURED IN ULSAN, KOREA FLUMETHASONE AS MANUFACTURED IN INDORE, INDIA TREPROSTINIL SODIUM AS MANUFACTURED IN ONTARIO, CANADA ENTECAVIR MONOHYDRATE AS MANUFACTURED IN TAINAN, TAIWAN ETRAVIRINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA STATUS Type SUBMIT DATE A A A A A A A II II II II III III II II 11/30/2011 11/29/2011 11/29/2011 12/6/2011 12/2/2011 12/2/2011 12/1/2011 12/1/2011 HOLDER SYMBIOTEC PHARMALAB LTD DAEWOONG BIO INC SEIKAGAKU CORP COSMA SPA POLIMERI EUROPA SPA POLIMERI EUROPA SPA FERMION OY DJADA PHARMACEUTICAL SA SUBJECT

4Q2012

TESTOSTERONE PROPIONATE, USP (MICRONIZED) AS MANUFACTURED IN (M.P.), INDIA URSODIOL(URSODEXOXYCHOLIC ACID) AS MANUFACTURED IN KYUNGGI-DO, KOREA SODIUM HYALURONATE AS MANUFACTURED IN KANAGAWA, JAPAN GLICLAZIDE (ESUB) AS MANUFACTURED IN BERGAMO, ITALY RIBLENE MP 31 R AS MANUFACTURED IN FERRARA, ITALY RIBLENE MR 10 R AS MANUFACTURED IN FERRARA, ITALY OSPEMIFENE AS MANUFACTURED IN OULU, FINLAND BEXAROTENE AS MANUFACTURED IN CHONGQING, CHINA FOR DJADA PHARMACEUTICAL SA

CASSETTE FOR THE PRODUCTION OF FLUORINE-18 SODIUM FLUORIDE ON THE TRACERLAB MX SYNTHESIS UNIT AS MANUFACTURED IN BEER SHEVA, ISRAEL TELMISARTAN METHYL ESTER AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA LIPOID SODIUM OLEATE B AS MANUFACTURED IN LUDWIQSHAFEN, GERMANY LAMINATED FILMS AND POUCHES (PET/A1/PE) FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN SUZHOU, P.R. CHINA PVC SHEET FOR SOLID PHARMACEUTICAL PACKAGING AS MANUFACTURED IN HANGZHOU, CHINA DALTEPARIN SODIUM PH.EUR. (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

CEFTRIAXONE SODIUM USP (STERILE) DRUG SUBSTANCE (PROCESS-II) (ESUB) AS MANUFACTURED IN PUNJAB, INDIA HARD GELATIN CAPSULE SHELL (PROCESS-II) (ESUB) AS MANUFACTURED IN DISTT. SOLAN (H.P), INDIA CARBIDOPA AS MANUFACTURED IN ANDHRA PRADESH, INDIA METFORMIN HYDROCHLORIDE USP AS MANUFACTURED IN MADURAI DISTRICT, TAMILNADU, INDIA SDM12, DILUTED NITROGLYCERIN USP AS MANUFACTURED IN TAMAQUA, PENNSYLVANIA FOR COPPERHEAD INVESTMENTS INC

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4Q2012EXCEL DMF# 25566 25567 A 25568 25569 25570 25571 25572 25573 25574 A 25575 A 25576 25577 25578 25579 25580 A 25581 25582 A 25583 25584 A 25585 A 25586 A 25587 25588 A 25589 25590 25591 A 25592 A 25593 A 25594 25595 A A II II 1/19/2012 6/6/2012 SUN PHARMACEUTICAL INDUSTRIES LTD K+S KALI GMBH II 12/19/2011 II 12/19/2011 ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD FARMABIOS S P A A A II II III 12/21/2011 1/30/2012 3/20/2012 C II II 12/13/2011 3/20/2012 HETERO DRUGS LTD EMCURE PHARMACEUTICALS LTD III 12/7/2011 AMPACET CORP III 12/13/2011 GUJARAT FOILS LTD A II II 12/13/2011 12/23/2011 A II II 12/13/2011 12/14/2011 ALEMBIC PHARMACEUTICALS LTD JIANGXI SYNERGY PHARMACEUTICAL CO LTD SMILAX LABORATORIES LTD FERMENTA BIOTECH LTD A A A A II II II II II 12/12/2011 12/12/2011 12/12/2011 12/12/2011 1/11/2012 QILU PHARMACEUTICAL CO LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD PAR PHARMACEUTICAL INC III 12/12/2011 A A A A A A II II II III II II II 12/8/2011 2/24/2012 12/29/2011 12/13/2011 12/13/2011 12/12/2011 12/12/2011 NEULAND LABORATORIES LTD LUPIN LTD NECTAR LIFESCIENCES LTD YAMANI YAKUHIN CO LTD HETERO DRUGS LTD NORAC INC SHANDONG FANGMING PHARMACEUTICAL GROUP CO LTD AMPACET CORP MONTELUKAST SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA STATUS Type SUBMIT DATE A IV II 12/8/2011 12/8/2011 HOLDER FONA INTERNATIONAL INC HETERO LABS LTD SUBJECT 815.086 BUBBLEGUM FLAVOR, NAT AS MANUFACTURED IN GENEVA, IL

4Q2012

ATAZANAVIR SULFATE AS MANUFACTURED IN HYDERABAD, ANDHRA PRADESH, INDIA

FOSAMPRENAVIR CALCIUM (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA CEFDINIR USP (ESUB) AS MANUFACTURED IN PUNJAB, INDIA DRYEN SILICA GEL DESICCANT AS MANUFACTURED IN SHIGA, JAPAN APREPITANT AS MANUFACTURED IN ANDHRA PRADESH, INDIA NGT-10100 DRUG SUBSTANCE AS MANUFACTURED IN AZUSA, CA GLICLAZIDE AS MANUFACTURED IN SHANDONG PROVINCE, CHINA 111818-K BLOMITE 818 AS MANUFACTURED IN RAYONG, THAILAND FOR AMPACET CORPORATION DOCETAXEL TRIHYDRATE AS MANUFACTURED IN SHANDONG P.R. CHINA ILOPERIDONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOSAMPRENAVIR CALCIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA SEVELAMER HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA PHENOXYBENZAMINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA FOR PAR PHARMACEUTICAL INC FAMOTIDINE USP AS MANUFACTURED IN GUJARAT, INDIA CELECOXIB AS MANUFACTURED IN JIANGXI PROVINCE, P.R. CHINA PANTOPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA CHOLECALCIFEROL USP (CRYSTALLINE VITAMIN D3) (ESUB) AS MANUFACTURED IN HIMACHAL PRADESH, INDIA BLISTER FOIL (BARE / COATED / PRINTED ALUMINIUM FOIL) AS MANUFACTURED IN GUJARAT, INDIA 474974 GREEN PP MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA, HEATH, OH ACYCLOVIR AS MANUFACTURED IN ANDHRA PRADESH, INDIA

PROPAFENONE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA POLYPEPTIDE LABORATORIES SWEDEN AB TERLIPRESSIN ACETATE AS MANUFACTURED IN LIMHAMN, SWEDEN API INC SHRIJI POLYMERS INDIA PVT LTD PROCARBAZINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN FAIRFIELD, NJ LIQUID MEDICATION DISPENSERS (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA FOR SHRIJI POLYMERS INDIA LTD CAPECITABINE AS MANUFACTURED IN ZHEJIANG, P.R. CHINA METHYLTESTOSTERONE (MICRONIZED) AS MANUFACTURED IN GROPELLO CAIROLI (PV), ITALY DOXERCALCIFEROL (ESUB) AS MANUFACTURED IN GUJARAT, INDIA POTASSIUM CHLORIDE 99.9% KCI PH. EUR., USP AS MANUFACTURED IN DEUTSCHLAND, GERMANY

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4Q2012EXCEL DMF# 25596 A 25597 25598 25599 A 25600 A 25601 25602 25603 25604 25605 25606 A 25607 25608 A 25609 A 25610 25611 25612 25613 25614 25615 A 25616 A 25617 A 25618 A 25619 25620 25621 A 25622 25623 25624 25625 A 25626 A II 12/23/2011 A A A II II II II 12/23/2011 12/23/2011 12/27/2011 12/23/2011 EUTICALS SPA INKE SA MAC CHEM PRODUCTS INDIA PVT LTD JIANGSU HANSOH PHARMACEUTICAL CO LTD JIANGSU HENGRUI MEDICINE CO LTD A A II II II 12/16/2011 12/16/2011 12/22/2011 SOCIETE INDUSTRIELLE DES OLEAGINEUX SOCIETE INDUSTRIELLE DES OLEAGINEUX TEVA PHARMACEUTICAL INDUSTRIES LTD II 12/22/2011 II 12/19/2011 SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD NEULAND LABORATORIES LTD III 12/13/2011 AMPACET CORP A A A A A III III II II II II 12/19/2011 12/19/2011 12/22/2011 2/12/2011 12/21/2011 12/20/2011 II 10/25/2011 JIANGXI FUSHINE PHARMACEUTICAL CO LTD EVONIK INDUSTRIES AG EVONIK INDUSTRIES AG MEDICHEM MANUFACTURING MALTA LTD VITAL LABORATORIES PVT LTD HETERO DRUGS LTD FARMABIOS S P A A III II 12/21/2011 12/22/2011 A A A A A III III III III II II 12/15/2011 12/21/2011 12/21/2011 12/15/2011 12/20/2011 12/13/2011 KRAIBURG TPE GMBH AND CO KG KRAIBURG TPE GMBH AND CO KG KRAIBURG TPE GMBH AND CO KG KRAIBURG TPE GMBH AND CO KG WUXI JIDA PHARMACEUTICAL CO. LTD. ZHEJIANG XIANJU PHARMACEUTICAL CO LTD KRAIBURG TPE GMBH AND CO KG SMS PHARMACEUTICALS LTD III 12/20/2011 FUJIMORI KOGYO CO LTD LAMINATED SHEET FOR USE IN OUTER PACKAGING OF DRUG PRODUCT AS MANUFACTURED IN YOKOHAMA CITY, JAPAN THERMOLAST M-TM#HET AS MANUFACTURED IN WALDKRAIBURG, GERMANY A A IV II V 12/13/2011 12/20/2011 12/20/2011 CABOT SANMAR LTD HAYASHIBARA CO LTD HAUPT PHARMA WOLFRATSHAUSEN GMBH STATUS Type SUBMIT DATE III 11/22/2011 HOLDER INDIAN EXTRUSIONS SUBJECT

4Q2012

POLYPROPYLENE (PP) AND PET BOTTLES WITH CAPS AS MANUFACTURED IN DAMAN, INDIA CAB-O-SIL M-5P FUMED SILICA AS MANUFACTURED IN TAMIL NADU, INDIA MALTOSE MONOHYDRATE AS MANUFACTURED IN OKAYAMA, JAPAN ASEPTIC PROCESS VALIDATION AS MANUFACTURED IN WOLFRATSHAUSEN, GERMANY

THERMOLAST M - TM(3 TO 7)MHD AS MANUFACTURED IN WALDKRAIBURG, GERMANY THERMOLAST M - TM(3 TO 4)RST AS MANUFACTURED IN WALDKRAIBURG, GERMANY THERMOLAST M-TM # ADT AS MANUFACTURED IN WALDKRAIBURG, GERMANY RISPERIDONE AS MANUFACTURED IN JIANGYIN CITY, CHINA TESTOSTERONE PROPIONATE NON-STERILE BULK AS MANUFACTURED IN ZHEJIANG, CHINA THERMOLAST M - TM#LFT AS MANUFACTURED IN WALDKRAIBURG, GERMANY RANITIDINE HYDROCHLORIDE USP (UNIT-VII) AS MANUFACTURED IN ANDHRA PRADESH, INDIA SULBACTAM AS MANUFACTURED IN JINGDEZHEN CITY, CHINA DEGALAN PM 555 AS MANUFACTURED IN DARMSTADT, GERMANY DEGALAN VP 4164 E AS MANUFACTURED IN DARMSTADT, GERMANY MED-200400/M AS MANUFACTURED IN HAL FAR BBG, MALTA SCOPOLAMINE HYDRO BROMIDE AS MANUFACTURED IN GUJARAT, INDIA FOSAPREPITANT DIMEGLUMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA BUDESONIDE MICRONIZED STERILE AS MANUFACTURED IN GROPELLO CAIROLI (PV), ITALY 100671 PP UV MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA AND HEATH, OH EMTRICITABINE AS MANUFACTURED IN SHANGHAI, CHINA PEMETREXED DISODIUM (FORM IV) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR NEULAND LABORATORIES LTD BXR US REFINED SOYBEAN OIL AS MANUFACTURED IN CEDEX, FRANCE BXR US REFINED OLIVE OIL AS MANUFACTURED IN CEDEX, FRANCE OMEPRAZOLE AS MANUFACTURED IN PRIGORJE BRDOVECKO, CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD ROCURONIUM BROMIDE AS MANUFACTURED IN ROZZANO (MI), ITALY RIZATRIPTAN BENZOATE AS MANUFACTURED IN BARCELONA, SPAIN DACARBAZINE USP AS MANUFACTURED IN DISTRICT THANE, INDIA DULOXETINE HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU, CHINA AZELASTINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU, CHINA

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4Q2012EXCEL DMF# 25627 A 25628 A 25629 25630 25631 A 25632 25633 25634 25635 25636 25637 25638 A 25639 25640 25641 25642 A 25643 A 25644 A 25645 25646 25647 25648 25649 25650 A 25651 25652 25653 25654 A 25655 A 25656 A 25657 A 25658 P *** PENDING FILING REVIEW *** II 2/20/2012 SUN PHARMACEUTICAL INDUSTRIES LTD II 1/13/2012 WOCKHARDT LTD III 12/30/2011 INTERNATIONAL CONVERTER LLC A A A II II II II 12/30/2011 12/30/2011 12/30/2011 1/3/2012 MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD MYLAN LABORATORIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD A A A A A IV II II II II II 12/27/2011 2/16/2012 2/21/2012 12/30/2011 1/16/2012 1/10/2012 IDEAL CURES PVT LTD CADILA HEALTHCARE LTD CADILA HEALTHCARE LTD RAKS PHARMA PVT LTD RANBAXY LABORATORIES LTD AUROBINDO PHARMA LTD II 1/29/2011 CHEMWERTH INC III 1/3/2012 HUHTAMAKI RONSBERG A A I II II II II 12/29/2011 12/27/2011 12/28/2011 12/28/2011 MYLAN LABORATORIES LTD SUZHOU LIXIN PHARMACEUTICAL CO LTD QILU PHARMACEUTICAL CO LTD MEGAFINE PHARMA P LTD SEVELAMER CARBONATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA PEMETREXED DISODIUM AS MANUFACTURED IN JIANGSU, CHINA A A A A A A II II II III II II II 12/13/2011 2/15/2012 12/27/2011 11/20/2011 12/28/2011 12/29/2011 12/29/2011 A A II II II 12/23/2011 12/27/2011 12/5/2011 CRYSTAL PHARMA SAU EVERLIGHT CHEMICAL INDUSTRIAL CORP HUNAN YUANTONG PHARMACEUTICAL CO LTD VITAL LABORATORIES PVT LTD APICORE LLC SCINOPHARM TAIWAN LTD VIVEK POLYMER (INDIA) RAKS PHARMA PVT LTD HETERO DRUGS LTD II 12/22/2011 STATUS Type SUBMIT DATE III 12/12/2011 HOLDER THURINGER PHARMAGLAS GMBH AND CO KG SIEGFRIED USA LLC SUBJECT

4Q2012

VIALS AND AMPOULES MADE OF TUBULAR GLASS AS MANUFACTURED IN NEUHAUS/RENNWEG, GERMANY OXYMORPHONE HYDROCHLORIDE USP (LOW ABUK IMPURITY) AS MANUFACTURED IN PENNSVILLE, NEW JERSEY BUDESONIDE MICRONIZED AS MANUFACTURED IN BOECILLO (VALLADOLID), SPAIN RASAGILINE MESYLATE AS MANUFACTURED IN TAOYUAN HSIEN, TAIWAN DIOSMIN AS MANUFACTURED IN HUNAN PROVINCE, CHINA YOHIMBINE HYDROCHLORIDE AS MANUFACTURED IN MUMBAI, INDIA CLOFARABINE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA BIVALIRUDIN AS MANUFACTURED IN TAINAN, TAIWAN PLASTIC BOTTLES AND CLOSURES AS MANUFACTURED IN MAHARASHTRA, INDIA CELECOXIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA FEXOFENADINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

PHARMACEUTICAL WORKS POLPHARMA SA IBANDRONATE SODIUM AS MANUFACTURED IN STAROGARD GDANSKI, POLAND

ADEFOVIR DIPIVOXIL (NON STERILE, API) AS MANUFACTURED IN SHANDONG, CHINA PALIPERIDONE (NON- STERILE DRUG SUBSTANCE) AS MANUFACTURED IN NASHIK, INDIA FILM WRAPPER FOR TRANSDERMAL PATCHES AS MANUFACTURED IN RONSBERG, GERMANY MELPHALAN HCL, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN FREIBURG, GERMANY FOR CHEMWERTH INC ECOPAL TM RANGE OF ACRYLIC POLYMERS AS MANUFACTURED IN GUJARAT, INDIA SALMETEROL XINAFOATE US(ESUB) AS MANUFACTURED IN GUJARAT, INDIA ETHACRYNIC ACID USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA RABEPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOSAMPRENAVIR CALCIUM (ESUB) AS MANUFACTURED IN PUNJAB, INDIA RALOXIFENE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA PRASUGREL HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA DESMOPRESSIN ACETATE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA EZETIMIBE AS MANUFACTURED IN ANDHRA PRADESH, INDIA LOSARTAN POTASSIUM AS MANUFACTURED IN GAJRAULA, MALANPUR IN INDIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD FLEXIBLE PACKAGING FOR PHARMACEUTICAL APPLICATIONS AS MANUFACTURED IN CALDWELL, OH AND LUKA, MS DESVENLAFAXINE SUCCINATE MONOHYDRATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA ATORVASTATIN CALCIUM (AMORPHOUS) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA

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4Q2012EXCEL DMF# 25659 A 25660 25661 25662 25663 25664 25665 25666 A 25667 A 25668 25669 25670 A 25671 A 25672 25673 25674 25675 25676 25677 25678 25679 25680 25681 25682 C 25683 25684 25685 A 25686 A 25687 25688 A 25689 25690 A 25691 A IV 1/10/2012 LIPOID GMBH LIPOID PE 16:0/16:0-PEG 5000 (MPEG 5000-DPPE) AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY A III IV 12/20/2011 1/9/2012 SIBO G DOO FONA INTERNATIONAL INC A II III 1/2/2012 1/6/2012 POLYDRUG LABORATORIES PVT LTD OREM ACCESS BIO INC II 1/9/2012 A A II V II 12/22/2011 1/6/2012 12/20/2011 ICROM SPA DURECT CORP ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD HETERO LABS LTD A A P A A A A A A A IV II II II II II II II 12/30/2011 1/4/2012 1/4/2012 1/4/2012 1/5/2012 1/5/2012 1/3/2012 1/6/2012 II II 1/4/2012 4/10/2012 SAMYANG GENEXBIO CORP LUNDBECK PHARMACEUTICALS ITALY SPA *** PENDING FILING REVIEW *** ILE PHARMACEUTICAL MATERIALS CO LTD AMINO CHEMICALS LTD AMINO CHEMICALS LTD SAMYANG GENEXBIO CORP DAEWOONG BIO INC DAEWOONG BIO INC JARI PHARMACEUTICAL CO LTD MSN LABORATORIES LTD ENTERIC FILM COATING SYSTEMS AS MANUFACTURED IN TIANJIN, CHINA RUFINAMIDE AS MANUFACTURED IN MARSA, MALTA DICLOFENAC EPOLAMINE AS MANUFACTURED IN MARSA, MALTA DOCETAXEL TRIHYDRATE AS MANUFACTURED IN SEOL, KOREA STERILE MEROPENEM AS MANUFACTURED IN KYUNGGI-DO, KOREA IOPROMIDE AS MANUFACTURED IN KYUNGGI-DO, KOREA OXALIPLATIN AS MANUFACTURED IN JIANGSU, CHINA III 12/28/2011 H AND H GLASS INC P A II II 2/16/2012 1/17/2012 *** PENDING FILING REVIEW *** UNIMARK REMEDIES LTD SRI KRISHNA PHARMACEUTICALS LTD II 2/2/2012 CHEMWERTH INC A P A A A A II II II II II 3/27/2012 1/3/2012 12/10/2010 12/30/2011 12/22/2011 II 3/23/2012 IPCA LABORATORIES LTD *** PENDING FILING REVIEW *** IPCA LABORATORIES LTD TORRENT PHARMACEUTICALS LTD ALP PHARM BEIJING CO LTD SCINOPHARM TAIWAN LTD ALP PHARM BEIJING CO LTD TRIMETHOPRIM USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA REPAGLINIDE AS MANUFACTURED IN GUJARAT, INDIA STATUS Type SUBMIT DATE II 12/30/2011 HOLDER SUBJECT

4Q2012

ZHEJIANG HISUN PHARMACEUTICAL CO LTD MITOMYCIN ALTERNATIVE PROCESS AS MANUFACTUED IN TAIZHOU, ZHEJIANG, CHINA ESCITALOPRAM OXALATE (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA

FEBUXOSTAT AS MANUFACTURED IN HUBEI, CHINA FOR ALP PHARM BEIJING CO LTD BORTEZOMIB AS MANUFACTURED IN TAINAN, TAIWAN CILOSTAZOL USP AS MANUFACTURED IN CHONGQING, CHINA FOR ALP PHARM BEIJING CO LTD BUSULFAN USP NON-STERILE BULK DRUG (ESUB) AS MANUFACTURED IN SICHUAN PROVINCE, P. R. OF CHINA FOR CHEMWERTH INC DRONEDARONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA BUTORPHANOL TARTRATE USP (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA AMBER AND FLINT GLASS AS MANUFACTURED IN HSINCHU, TAIWAN FOR H & H GLASS INC DOCETAXEL ANHYDROUS AS MANUFACTURED IN DAEJEON, KOREA ETHOTOIN (ESUB) AS MANUFACTURED IN PADOVA, ITALY FOR LUNDBECK LLC

FOSAPREPITANT DIMEGLUMINE [ROUTE CODE: "FD"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA RISPERIDONE AS MANUFACTURED IN CONCOREZZO, ITALY SUCROSE ACETATE ISOBUTYRATE (SAIB) AS MANUFACTURED IN VACAVILLE, CA ARIPIPRAZOLE AS MANUFACTURED IN ZHEJIANG, CHINA IRINOTECAN HYDROCHLORIDE TRIHYDRATE, USP (FORM B) AS MANUFACTURED IN ANDHRA PRADESH, INDIA CARISOPRODOL AS MANUFACTURED IN MAHARASHTRA, INDIA MOISTURE AND ODOUR REGULATING PRODUCTS AS MANUFACTURED IN HYDERABAD, ANDHRA PRADESH, INDIA CLOSURES SIBO AS MANUFACTURED IN SLOVENIA, EUROPE PRODUCT # 889.0069U PEACH FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL

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4Q2012EXCEL DMF# 25692 25693 25694 A 25695 25696 A 25697 A 25698 A 25699 A 25700 25701 25702 A 25703 A 25704 25705 A 25706 A 25707 A 25708 A 25709 A 25710 A 25711 25712 25713 A 25714 A 25715 A 25716 A 25717 A 25718 A II 1/16/2012 SHANDONG NEW TIME PHARMACEUTICAL CO LTD II 2/23/2012 II 1/14/2012 QILU ANTIBIOTICS PHARMACEUTICAL CO LTD COSMA SPA II 1/17/2012 II 1/16/2012 SHANDONG NEW TIME PHARMACEUTICAL CO LTD VIWIT PHARMACEUTICAL CO LTD A A II II II 2/18/2012 1/18/2012 1/5/2012 II 12/29/2011 II 1/9/2012 IV 1/16/2012 II 12/20/2011 II 12/29/2011 A IV II 10/22/2011 1/9/2012 FONA INTERNATIONAL INC QILU ANTIBIOTICS LINYI PHARMACEUTICAL CO LTD KYONGBO PHARMACEUTICAL CO LTD 856.061 GRAPE FLAVOR, ARTIFICIAL AS MANUFACTURED IN GENEVA, IL II 4/9/2012 BIOCON LTD A A II II III 1/9/2012 1/9/2012 1/9/2012 IV 1/10/2012 II 12/30/2011 II 12/30/2011 SHANDONG KEXING BIOPRODUCTS CO LTD A II II 5/15/2012 3/20/2012 ENALTEC LABS PRIVATE LTD USV LIMITED STATUS Type SUBMIT DATE A A III II II 1/3/2012 1/4/2012 1/18/2012 HOLDER ADHESIVES RESEARCH INC AVRA LABORATORIES PRIVATE LTD AUROBINDO PHARMA LTD SUBJECT MA-69 (R-9667) AS MANUFACTURED IN GLEN ROCK, PA

4Q2012

IRINOTECAN HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA TADALAFIL (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA DALFAMPRIDINE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA COLESEVELAM HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA

RECOMBINANT HUMAN GRANULOCYTE COLONY-STIMULATING FACTOR AS MANUFACTURED IN ZHANG QIU-SHANDONG, CHINA SHANDONG KEXING BIOPRODUCTS CO LTD RECOMBINANT HUMAN ERYTHROPOIETIN AS MANUFACTURED IN ZHANG QIUSHANDONG, CHINA CELANESE EVA PERFORMANCE POLYMERS ETHYLENE VINYL ACETATE COPOLYMER, VITALDOSE TM K2390.X01 AS MANUFACTURED IN ALBERTA, CANADA FORMOSA LABORATORIES INC LINEZOLID AS MANUFACTURED IN TAOYUAN, TAIWAN FORMOSA LABORATORIES INC GREINER PACKAGING GMBH ULIPRISTAL ACETATE AS MANUFACTURED IN TAOYUAN, TAIWAN 250ML AND 950 ML PLASTIC BOTTLE INTENDED FOR PACKAGING ORAL SOLID DOSAGE FORMS AS MANUFACTURED IN WERNBERG, AUSTRIA. RASTATT, GERMANY TRAVOPROST USP DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN BANGALORE, INDIA

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD CELANESE EVA PERFORMANCE POLYMERS ETHYLENE VINYL ACETATE COPOLYMER, VITALDOSE K2389.X01 AS MANUFACTURED IN ALBERTA, CANADA SHANGHAI ZHONGXI SUNVE HYDROXYCHLOROQUINE SULFATE (USP) AS MANUFACTURED IN SHANGHAI, P. R. CHINA PHARMACEUTICAL CO LTD KYONGBO PHARMACEUTICAL CO LTD CEFTAZIDIME STERILE, BULK AS MANUFACTURED IN CHUNGCHEONG NAM-DO, REPUBLIC OF KOREA MACLEODS PHARMACEUTICALS LTD RABEPRAZOLE SODIUM (ESUB) AS MANUFACTURED IN GUJARAT, INDIA HETERO DRUGS LTD MSN ORGANICS PVT LTD OMEPRAZOLE, USP (FORM B) AS MANUFACTURED IN ANDHRA PRADESH, INDIA TOPIRAMATE USP [ROUTE CODE - "TI"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA POTASSIUM CLAVULANATE, DILUTED WITH SILICON DIOXIDE IN THE RATIO 1:1 AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA APREPITANT (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN TENGZHOU, CHINA STERILE CEFAZOLIN SODIUM PROCESS 1 AS MANUFACTURED IN JINAN CITY, CHINA MILNACIPRAN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN CISERANO(BERGAMO), ITALY CLAVULANATE POTASSIUM AS MANUFACTURED IN SHANDONG PROVINCE, P. R. CHINA

TERBINAFINE HYDROCHLORIDE (NON STERILE, API) AS MANUFACTURED IN SHANDONG PROVINCE, P. R. OF CHINA MEROPENEM STERILE, BULK AS MANUFACTURED IN CHUNGCHEONG NAM-DO, REP OF KOREA VORICONAZOLE AS MANUFACTURED IN ZHEJIANG, CHINA

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4Q2012EXCEL DMF# 25719 A 25720 25721 A 25722 A 25723 A 25724 A 25725 A 25726 A 25727 25728 25729 25730 25731 A 25732 A 25733 25734 25735 25736 25737 I 25738 25739 25740 A 25741 A 25742 25743 A 25744 25745 25746 25747 A 25748 A II 1/30/2012 BLUE ZONE TECHNOLOGIES LTD A A A II II II II 2/23/2012 3/26/2012 1/31/2012 1/30/2012 A II II 1/25/2012 6/18/2012 SIGNA SA DE CV JUHUA GROUP CORP PHARMACEUTICAL FACTORY EMCURE PHARMACEUTICALS LTD DR REDDYS LABORATORIES LTD APOTEX PHARMACHEM INDIA PVT LTD TEVA PHARMACEUTICAL INDUSTRIES LTD IV 1/28/2012 TOAGOSEI CO LTD A A II IV II 2/7/2012 1/10/2012 1/26/2012 A A A A II II II II II 1/26/2012 3/8/2012 1/26/2012 1/24/2012 12/20/2011 NEULAND LABORATORIES LTD DR REDDYS LABORATORIES LTD BACHEM SA BCN PEPTIDES ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD WISDOM PHARMCEUTICAL CO LTD TAKASAGO INTERNATIONAL CORP POLYMED THERAPEUTICS INC III 1/19/2012 ADVANCED SCIENTIFICS INC A A A A II II IV II II 3/26/2012 1/19/2011 1/23/2012 1/24/2012 1/25/2012 LUPIN LTD BIOCON LTD FONA INTERNATIONAL INC MSN LABORATORIES LTD NS PHARMA INC II 1/25/2012 CHENG FONG CHEMICAL CO LTD III 12/10/2011 GUJARAT FOILS LTD III 1/11/2012 HANGZHOU PLASTICS INDUSTRIAL CO LTD III 1/11/2012 HANGZHOU PLASTICS INDUSTRIAL CO LTD III 1/11/2012 A II II 1/19/2012 12/20/2011 STATUS Type SUBMIT DATE II 1/16/2012 HOLDER SHANDONG NEW TIME PHARMACEUTICAL CO LTD APOTEX PHARMACHEM INDIA PVT LTD ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD HANGZHOU PLASTICS INDUSTRIAL CO LTD SUBJECT

4Q2012

POTASSIUM CLAVULANATE, DILUTED WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO 1:1 AS MANUFACTURED IN SHANDONG PROVINCE, P. R. CHINA CAPECITABINE USP AS MANUFACTURED IN BANGALORE, INDIA CARVEDILOL DIHYDROGEN PHOSPHATE HEMIHYDRATE AS MANUFACTURED IN ZHEJIANG, CHINA PP/A1/PVC/PVDC COMPOSITE SHEET FOR SOLID PHARMACEUTICAL PACKAGING AS MANUFACTURED IN HANGZHOU, CHINA PVC/PVDC COMPOSITE SHEET FOR SOLID PHARMACEUTICAL PACKAGING AS MANUFACTURED IN HANGZHOU, CHINA PVC/PE/PVDC COMPOSITE SHEET FOR SOLID PHARMACEUTICAL PACKAGING AS MANUFACTURED IN HANGZHOU, CHINA STRIP FOIL (BARE/COATED/LAMINATED/PRINTED/ALUMINUM FOIL) AS MANUFACTURED IN GUJARAT, INDIA 4-PHENYLBUTYRIC ACID SODIUM SALT AS MANUFACTURED IN TAOYUAN COUNTY, TAIWAN DESVENLAFAXINE BENZOATE(ESUB) AS MANUFACTURED IN GUJARAT, INDIA HYDROXY ECHINOCANDIN AS MANUFACTURED IN BANGALORE, INDIA 825.527 N-C CHERRY FLAVOR, ARTIFICIAL AS MANUFACTURED IN GENEVA, IL BICALUTAMIDE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA NS-018 ACTIVE DRUG SUBSTANCE AS MANUFACTURED IN YOKKAICHI, MIE, JAPAN FOR NS PHARMA INC POLYETHLENE BAGS AND TRANSFER TUBE ASSEMBLIES AS MANUFACTURED IN MILLERSBURG, PA DEFERASIROX AS MANUFACTURED IN ANDHRA PRADESH, INDIA ZOLMITRIPTAN (PROCESS-II) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ZIPRASIDONE HCL H2O AS MANUFACTURED IN VIONNAZ, SWITZERLAND VASOPRESSIN AS MANUFACTURED IN BARCELONA, SPAIN LOSARTAN POTASSIUM AS MANUFACTURED IN ZHEJIANG, CHINA BENAZEPRIL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN JIANGSU, CHINA DORANGE FLAVOR OT-42107 AS MANUFACTURED IN IBARAKI, JAPAN BORTEZOMIB DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING, CHINA FOR POLYMED THERAPEUTICS INC POLYACRYLATE POLYMERS- ARONVIS AH-105, AH-105X, AH-106X, MX, SX, AND JURYMER AC-10H AS MANUFACTURED IN KAGAWA, JAPAN TELMISARTAN USP/EP AS MANUFACTURED IN TOLUCA ESTADO DE MEXICO, MEXICO DIFLUNISAL USP (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA MYCOPHENOLATE MOFETIL USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ASENAPINE MALEATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA MYCOPHENOLATE MOFETIL USP AS MANUFACTURED IN BANGALORE, INDIA DESVENLAFAXINE SUCCINATE HPMC PRELIMINARY MIX AS MANUFACTURED IN PRIGORJE BRDOVECKO, CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD. DESFLURANE USP AS MANUFACTURED IN ONTARIO, CANADA

Page 791

4Q2012EXCEL DMF# 25749 A 25750 25751 25752 25753 25754 25755 25756 25757 A 25758 25759 25760 A 25761 25762 A 25763 25764 25765 25766 A 25767 25768 A 25769 A 25770 25771 A 25772 25773 25774 A 25775 A 25776 25777 A 25778 25779 A A II II 2/27/2012 2/14/2012 ALEMBIC PHARMACEUTICALS LTD API DIV INOGENT LABORATORIES PRIVATE LTD P II 2/13/2012 II 12/30/2011 WATERSTONE PHARMACEUTICALS HUBEI TIANMEN CO LTD *** PENDING FILING REVIEW *** APOTEX PHARMACHEM INC P A II III 3/29/2012 2/7/2012 *** PENDING FILING REVIEW *** GLENMARK GENERICS LTD PROMENS HF A II II 2/9/2012 6/29/2012 HETERO LABS LTD THE PROCTER AND GAMBLE CO II 2/7/2012 N II 3/1/2012 NOT AN ASSIGNED NUMBER ORCHID CHEMICALS AND PHARMACEUTICALS LTD POLYMED THERAPEUTICS INC RISEDRONATE SODIUM (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA A C A II II II II 3/19/2012 3/20/2012 3/19/2012 7/25/2012 EMCURE PHARMACEUTICALS LTD EMCURE PHARMACEUTICALS LTD EMCURE PHARMACEUTICALS LTD MALLINCKRODT INC A II II 2/24/2012 2/8/2012 UNIMARK REMEDIES LTD AMOLI ORGANICS PVT LTD A A II II II 2/3/2012 1/18/2012 2/3/2012 FERRO PFANSTIEHL LABORATORIES INC JIANGSU YEW PHARMACEUTICAL CO LTD LIFECORE BIOMEDICAL LLC A A A A A A A II II II II IV IV III III 3/20/2012 2/24/2012 2/10/2012 4/2/2012 2/3/2012 1/10/2012 2/1/2012 2/27/2012 EMCURE PHARMACEUTICALS LTD LUPIN LTD PAN DRUGS LTD LUPIN LTD FONA INTERNATIONAL INC JUKU ORCHEM PRIVATE LTD DA PRO RUBBER INC SANNER GMBH STATUS Type SUBMIT DATE II 1/30/2012 HOLDER TEVA PHARMACEUTICALS INDUSTRIES LTD SUBJECT

4Q2012

DESVENLAFAXINE SUCCINATE AS MANUFACTURED IN BEER SHEVA, ISRAEL AND PRIGORJE BRDOVECKO, CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD. NISOLDIPINE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA DESVENLAFAXINE SUCCINATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA GUAIFENESIN USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA RALTEGRAVIR POTASSIUM (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA 856.485 N-C GRAPE FLAVOR, ART AS MANUFACTURED IN GENEVA, IL MICROCRYSTALLINE CELLULOSE USP AS MANUFACTURED IN TAMILNADU, INDIA DPXB433-5 AS MANUFACTURED IN BROKEN ARROW, OK DESICCANT CARTRIDGES AS MANUFACTURED IN BENSHEIM, GERMANY; KUNSHAN, CHINA; BUDAPEST, HUNGARY FOR SANNER GMBH PODOPHYLLOTOXIN (P-126) AS MANUFACTURED IN WAUKEGAN, IL PACLITAXEL AS MANUFACTURED IN JIANGSU, CHINA SODIUM HYALURONATE POWDER, SPECIFICATION LPD-9800037, PH 4.0 PROCESS AS MANUFACTURED IN CHASKA, MN FEBUXOSTAT (ESUB) AS MANUFACTURED IN GUJARAT, INDIA LEVETIRACETAM USP [ROUTE CODE - LVS] (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA IBUTILIDE FUMARATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA RIZATRIPTAN BENZOATE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ARGATROBAN MONOHYDRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA HYDROMORPHONE HYDROCHLORIDE USP (NP), MALLINCKRODT INC. CODE 3222 (ESUB) AS MANUFACTURED IN ST. LOUIS, MISSOURI

CABAZITAXEL MONOHYDRATE AS MANUFACTURED IN CHONGQING, CHINA FOR POLYMED THERAPEUTICS INC QUETIAPINE FUMARATE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ALIGN PRODUCT CONTAINING BIFANTIS (BIFIDOBACTERIUM LONGUM SUBSP. INFANTIS 36524) (ESUB) AS MANUFACTURED IN HOLLAND, MI FOR THE PROCTER & GAMBLE COMPANY SITAGLIPTIN PHOSPHATE (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA POLYETHYLENE VIALS AS MANUFACTURED IN LANGESKOV, DENMARK FOR PROMENS HR. LAMOTRIGINE AS MANUFACTURED IN HUBEI TIANMEN PROVINCE, CHINA

DESVENLAFAXINE SUCCINATE MONOHYDRATE AS MANUFACTURED IN BRANTFORD ONTARIO, CANADA FLUOXETINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA LAMOTRINGINE AS MANUFACTURED IN HYDERABAD, INDIA

Page 792

4Q2012EXCEL DMF# 25780 A 25781 A 25782 A 25783 A 25784 A 25785 25786 A 25787 II 3/27/2012 LUPIN LTD A II IV 1/30/2012 2/14/2012 MICRO LABS LTD INDIA FMC CORP FMC BIOPOLYMER DIV II 2/15/2012 II 2/13/2012 GUANGZHOU HANFANG PHARMACEUTICAL CO LTD AVANTI POLAR LIPIDS INC III 1/31/2012 II 2/10/2012 ZHEJIANG NEO DANKONG PHARMACEUTICAL CO LTD AMCOR FLEXIBLES GENT STATUS Type SUBMIT DATE III 2/10/2012 HOLDER NEX PERFORMANCE FILMS SUBJECT

4Q2012

NEX 1509 SINGLE-LAYER POLYETHYLENE SHEETING FILM AS MANUFACTURED IN TURNERS FALLS, MA ROSUVASTATIN CALCIUM, NON- STERILE BULK DRUG SUBSTANCES AS MANUFACTURED IN TAIZHOU, CHINA EXTRUDED FILMS AND LAMINATES FOR PACKAGING AS MANUFACTURED IN GENT, BELGIUM VINORELBINE TARTRATE, USP AS MANUFACTURED IN GUANGDONG, CHINA (5Z,8Z, 11Z)-N-CYCLOPROPYL-14-(N-ISOPROPYL-HEXANAMIDO) TETRADECA-5,8,11TRIENAMIDE (CMX-20) AS MANUFACTURED IN ALABASTER, ALABAMA MELOXICAM USP AS MANUFACTURED IN KARNATAKA, INDIA AVICEL(R) DG BINDER - MICROCRYSTALLINE CELLULOSE AND ANHYDROUS DICALCIUM PHOSPHATE AS MANUFACTURED IN BETHLEHEM, PENNSYLVANIA FOR FMC CORP( FMC BIOPOLYMER DIV) TENOFOVIR DISOPROXIL FUMARATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA

A 25788 25789 25790 25791 25792 25793 A 25794 25795 A 25796 A 25797 A 25798 25799 A 25800 A 25801 A 25802 25803 A 25804 25805 A A II II 3/27/2012 3/26/2012 EMCURE PHARMACEUTICALS LTD EMCURE PHARMACEUTICALS LTD A III II 2/8/2012 2/10/2012 AVANTIS PACKAGING INC SYMRISE AG II 2/22/2012 HEINKE TECHNOLOGY INC II 2/21/2012 HETERO LABS LTD A II III 2/16/2012 2/17/2012 II 2/17/2012 CHROMO LABORATORIES INDIA PRIVATE LTD SYMBIOTEC PHARMALAB LTD DOCTORPACK INDIA PVT LTD II 2/17/2012 CRYSTAL PHARMA SAU A II II 3/14/2012 4/9/2012 MACLEODS PHARMACEUTICALS LTD MACLEODS PHARMACEUTICALS LTD LANSOPRAZOLE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA VARDENAFIL HYDROCHLORIDE TRIHYDRATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA DROSPIRENONE NON MICRONIZED AND MICRONIZED AS MANUFACTURED IN BOECILLO (VALLADOLID), SPAIN CANDESARTAN CILEXETIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA BETAMETHASONE DIPROPIONATE AS MANUFACTURED IN MADHYA PRADESH, INDIA PLASTIC CONTAINER CLOSURE SYSTEM 'SQUEEZE NASAL SPRAY/NEBULIZER SYSTEM' AS MANUFACTURED IN BANGALORE, INDIA BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA PRE-FILLED VAGINAL APPLICATOR WITH SIDE DISPERSION TIP AS MANUFACTURED IN LINCOLN, NE PLASTIC BOTTLES & CONTAINERS AS MANUFACTURED IN QUEBEC, CANADA 210363 NATURAL & ARTIFICIAL FLAVOR LEMON TYPE AS MANUFACTURED IN HOLZMINDEN, GERMANY DOCETAXEL USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ZILEUTON USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA P P A A A II II II II 1/19/2012 2/14/2012 6/29/2012 4/9/2012 *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** MEITEK TECHNOLOGY QINGDAO CO LTD FARMABIOS S P A MACLEODS PHARMACEUTICALS LTD MACLEODS PHARMACEUTICALS LTD CHONDROITIN SULFATE SODIUM AS MANUFACTURED IN SHANDONG PROVINCE, CHINA MELPHALAN HYDROCHLORIDE AS MANUFACTURED IN GROPELLO CAIROLI (PV), ITALY CELECOXIB (ESUB) AS MANUFACTURED IN GUJARAT, INDIA IBANDRONATE SODIUM MONOHYDRATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA

Page 793

4Q2012EXCEL DMF# 25806 A 25807 A 25808 25809 25810 A 25811 A 25812 A 25813 A 25814 25815 A 25816 25817 25818 25819 25820 A 25821 A 25822 A 25823 25824 25825 A 25826 25827 25828 25829 A 25830 25831 A 25832 A 25833 25834 A A IV III 2/28/2012 2/21/2012 IV 2/28/2012 A II II 2/22/2012 2/24/2012 SWATI SPENTOSE PVT LTD A A A II II II II 2/24/2012 2/22/2012 3/24/2012 3/24/2012 A A II IV II 10/12/2011 2/24/2012 2/22/2012 II 2/23/2012 II 2/23/2012 A A A A II II II III II 4/2/2012 2/22/2012 2/20/2012 4/5/2012 4/2/2012 LUPIN LTD NEULAND LABORATORIES LTD APOTEX PHARMACHEM INDIA PVT LTD NAGL MANUFACTURING CO LUPIN LTD A II II 2/22/2012 2/22/2012 CATALENT PHARMA SOLUTIONS LLC APOTEX PHARMACHEM INC III 2/17/2012 IV 2/15/2012 II 12/22/2011 A A II II II 3/27/2012 3/30/2012 3/14/2012 EMCURE PHARMACEUTICALS LTD EMCURE PHARMACEUTICALS LTD AUROBINDO PHARMA LTD ETODOLAC USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA II 3/31/2012 EMCURE PHARMACEUTICALS LTD STATUS Type SUBMIT DATE II 3/27/2012 HOLDER EMCURE PHARMACEUTICALS LTD SUBJECT

4Q2012

PROMETHAZINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA BENDAMUSTINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA

ACAMPROSATE CALCIUM (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA

TELMISARTAN USP (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA JOHNSON MATTHEY INC PHARMACEUTICAL JOHNSON MATTHEY 1319 AS MANUFACTURED IN WEST DEPTFORD, NJ MATERIALS GROUP ABELEI INC 164A50 NATURAL LEMON LIME FLAVOR WONF POWDER AS MANUFACTURED IN NORTH AURORA, IL PROMENS HF CYCLOOLEFIN VIALS AS MANUFACTURED IN LANGESKOV, DENMARK FOR PROMENS HF. MDV3100, 40MG, CAPSULES (SOFTGELS) AS MANUFACTURED IN ST. PETERSBURG, FL TADALAFIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA AND BRANTFORD ONTARIO, CANADA FOR APOTEX PHARMACHEM INC. ESTRADIOL HEMIHYDRATE (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA BRINZOLAMIDE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA LEVOTHYROXINE SODIUM USP AS MANUFACTURED IN BANGALORE, INDIA FLO-THRU APPLICATOR (ESUB) AS MANUFACTURED IN OMAHA, NE

AZITHROMYCIN MONOHYDRATE USP (PROCESS B) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA NINGBO RENJIAN PHARMACEUTICAL GROUP HUMAN CHORIONIC GONADOTROPIN USP AS MANUFACTURED IN ZHEJIANG PROVINCE, CO LTD CHINA FUJIAN SOUTH PHARMACEUTICAL CO LTD PACLITAXEL (SEMI-SYNTHETIC) USP NON STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN FUJIAN PROVINCE, P. R. OF CHINA MELODY HEALTHCARE PVT LTD MONTELUKAST SODIUM AS MANUFACTURED IN MAHARASHTRA, INDIA FONA INTERNATIONAL INC JIANGXI SYNERGY PHARMACEUTICAL CO LTD OLON SPA SWATI SPENTOSE PVT LTD CTX LIFE SCIENCES PVT LTD CTX LIFE SCIENCES PVT LTD 826.595 CHOCOLATE EXTRACT, NAT AS MANUFACTURED IN GENEVA, IL GABAPENTIN[H] AS MANUFACTURED IN JIANGXI PROVINCE, P.R. CHINA BENDAMUSTINE HCL AS MANUFACTURED IN RODANO (MI), ITALY PENTOSAN POLYSULFATE SODIUM AS MANUFACTURED IN GUJARAT, INDIA ALENDRONATE SODIUM USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA TERAZOSIN HYDROCHLORIDE DIHYDRATE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA LIDOCAINE USP AS MANUFACTURED IN GUJARAT, INDIA

ST GOBAIN PERFORMANCE PLASTICS CORP TYGON? 2475 HIGH PURITY TUBING AND TYGON? 2475 I.B. HIGH PURITY PRESSURE TUBING AS MANUFACTURED IN AKRON, OHIO FONA INTERNATIONAL INC 800.119 TOASTED ALMOND FLAVOR EMULSION, NAT WONF AS MANUFACTURED IN GENEVA, IL FONA INTERNATIONAL INC 816.0530U BUTTER TYPE FLAVOR, NAT AS MANUFACTURED IN GENEVA, IL AMPACET CORP 110730 WHITE PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA AND HEATH, OH

Page 794

4Q2012EXCEL DMF# 25835 A 25836 A 25837 A 25838 A 25839 A 25840 25841 A 25842 25843 25844 25845 25846 25847 25848 25849 25850 A 25851 A 25852 A 25853 A 25854 25855 25856 A 25857 A 25858 A 25859 25860 25861 25862 25863 25864 P A A A A P II II IV II 3/7/2012 3/7/2012 3/9/2012 3/7/2012 *** PENDING FILING REVIEW *** ULKAR KIMYA SANAYII VE TICARET AS ULKAR KIMYA SANAYII VE TICARET AS FONA INTERNATIONAL INC OLON SPA *** PENDING FILING REVIEW *** OLMESARTAN MEDOXOMIL USP AS MANUFACTURED IN TEKIRDAG, TURKEY IRBESARTAN USP AS MANUFACTURED IN TEKIRDAG, TURKEY II 3/30/2012 DR REDDYS LABORATORIES LTD II 6/13/2012 PAR PHARMACEUTICAL INC A A II II II 3/30/2012 3/24/2012 3/30/2012 II 3/23/2012 III 3/8/2012 JIANGSU HUALAN NEW PHARMACEUTICAL MATERIAL CO LTD 3D IMAGING DRUG DESIGN AND DEVELOPMENT LLC LUPIN LTD DR REDDYS LABORATORIES LTD NORAMCO INC II 2/28/2012 ORCHEV PHARMA PVT LTD A A A A A A A A III II II II II II II II II 3/1/2012 3/6/2012 2/29/2012 2/27/2012 3/2/2012 3/2/2012 3/1/2012 3/13/2012 3/5/2012 POLYONE CORP MAC CHEM PRODUCTS INDIA PVT LTD ZHUHAI UNITED LABORATORIES CO LTD AREVIPHARMA GMBH PROACTA INC PROACTA INC SECOND PHARMA CO LTD AMOLI ORGANICS PVT LTD SAVIOR LIFETEC CORP TAINAN BRANCH A II II 11/22/2011 11/22/2011 NANDU CHEMICAL INDUSTRIES NANDU CHEMICAL INDUSTRIES III 3/2/2012 DOCTORPACK INDIA PVT LTD IV 2/29/2012 ASAHI KASEI CHEMICALS CORP II 2/21/2012 MSN LABORATORIES LTD IV 4/1/2012 EMCURE PHARMACEUTICALS LTD STATUS Type SUBMIT DATE II 2/17/2012 HOLDER SUNBIO INC SUBJECT

4Q2012

METHOXY POLYETHYLENE GLYCOL PROPIONALDEHYDE 20,000 AS MANUFACTURED IN ANYANG CITY, S. KOREA PREMIX FOR BUSULFAN (WITHOUT ACTIVE) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA DEFERASIROX [ROUTE CODE - "DR"] [NON-STERILE DRUG SUBSTANCE] AS MANUFACTURED IN ANDHRA PRADESH, INDIA PREGELATINIZED STARCH (USP / NF) AS MANUFACTURED IN NARA, JAPAN FOR ASAHI KASEI CHEMICALS CORPORATION PLASTIC CONTAINER CLOSURE SYSTEM 'TR' DESIGN AS MANUFACTURED IN BANGALORE, INDIA 'POTASSIUM CHLORIDE BP' AS MANUFACTURED IN KARNATAKA, INDIA 'MAGNESIUM CHLORIDE HEXAHYDRATE BP' AS MANUFACTURED IN KARNATAKA, INDIA CC10132453WE (WHITE PEARL PP/PE) AS MANUFACTURED IN ELK GROVE VILLAGE, IL PACLITAXEL USP AS MANUFACTURED IN DISTRICT THANE, INDIA CEFOTAXIME SODIUM USP AS MANUFACTURED IN GUANGDONG, P. R. CHINA TORASEMIDE AS MANUFACTURED IN RADEBEUL, GERMANY SN35006 AS MANUFACTURED IN NORTH SYRACUSE, NY FOR PROACTA, INC. SN33962 AS MANUFACTURED IN NORTH SYRACUSE, NY FOR PROACTA, INC VALSARTAN AS MANUFACTURED IN SHANGYU CITY, P. R. CHINA HYDROCHLOROTHIAZIDE (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA STERILE SODIUM BICARBONATE USP AS MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA RANITIDINE HYDROCHLORIDE USP (POLYMORPH FORM - II) CRYSTALLINE POWDER GRADE AND DC GRADE AS MANUFACTURED IN GUJARAT STATE, INDIA BUTYL RUBBER STOPPERS AS MANUFACTURED IN CHONGQING CITY, CHINA FOR JIANGSU HUALAN NEW PHARMACEUTICAL MATERIAL CO., LTD SODIUM IODIDE I 124 (ESUB) AS MANUFACTURED IN LITTLE ROCK, ARKANSAS ESTRADIOL VALERATE USP(ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA GLATIRAMER ACETATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA CODEINE PHOSPHATE (ESUB) AS MANUFACTURED IN ATHENS, GA AND WILMINGTON, DE TOLCAPONE, USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA FOR PAR PHARMACEUTICAL INC ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

906.0312U RASPBERRY FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA, IL ROTIGOTINE AS MANUFACTURED IN RODANO (MI), ITALY

Page 795

4Q2012EXCEL DMF# 25865 A 25866 25867 A 25868 25869 25870 A 25871 25872 25873 A 25874 A 25875 A 25876 25877 A 25878 25879 A 25880 25881 A 25882 25883 A 25884 A 25885 A 25886 A 25887 25888 25889 25890 25891 A 25892 25893 A 25894 A II 3/19/2012 FORMOSA LABORATORIES INC A II II 4/9/2012 2/20/2012 CTX LIFE SCIENCES PVT LTD ALP PHARM BEIJING CO LTD A A A A II II II II II 4/2/2012 3/30/2012 3/29/2012 3/29/2012 3/12/2012 ALEMBIC PHARMACEUTICALS LTD API DIV JUBILANT LIFE SCIENCES LTD JUBILANT LIFE SCIENCES LTD JUBILANT LIFE SCIENCES LTD ZHUHAI UNITED LABORATORIES CO LTD III 3/6/2012 BORMIOLI ROCCO SPA BU PLASTICS III 3/6/2012 BORMIOLI ROCCO SPA BU PLASTICS III 3/5/2012 ESS DEE ALUMINIUM LTD A II II 3/19/2012 3/16/2012 COVALENT LABORATORIES PRIVATE LTD APTALIS PHARMA SRL A II II 3/30/2012 3/3/2012 DR REDDYS LABORATORIES LTD MSN LABORATORIES LTD A II II 12/12/2011 4/4/2012 A III II 3/13/2012 3/2/2012 II 3/16/2012 DSM SINOCHEM PHARMACEUTICALS NETHERLANDS BV SHAILY ENGINEERING PLASTICS LTD SHOUGUANG FUKANG PHARMACEUTICAL CO LTD ANYGEN CO LTD LUPIN LTD II 3/12/2012 SIFAVITOR SRL A A II II II 12/22/2011 3/30/2012 3/30/2012 ERREGIERRE SPA DR REDDYS LABORATORIES LTD DR REDDYS LABORATORIES LTD A A II II II 4/20/2012 3/31/2012 3/30/2012 IND SWIFT LABORATORIES LTD UNIMARK REMEDIES LTD ARCH PHARMALABS LTD A II II 3/28/2012 3/2/2012 SUN PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD STATUS Type SUBMIT DATE II 3/30/2012 HOLDER DR REDDYS LABORATORIES LTD SUBJECT

4Q2012

MILNACIPRAN HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA GANIRELIX ACETATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA SITAGLIPTIN PHOSPHATE AS MANUFACTURED IN MADHYA PRADESH, INDIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD. CLOPIDOGREL CAMPHOR SULFONATE (ESUB) AS MANUFACTURED IN PUNJAB, INDIA MEROPENEM TECHNICAL (ESUB) AS MANUFACTURED IN STATE-GUJARAT, INDIA PACLITAXEL USP (SEMI-SYNTHETIC) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA RIVASTIGMINE AS MANUFACTUTED IN BERGAMO, ITALY LENALIDOMIDE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ESCITALOPRAM OXALATE (PROCESS II) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA RACEPINEPHRINE HYDROCHLORIDE AS MANUFACTURED IN MURCIA, SPAIN FOR SIFAVITOR S.R.L AMOXICILLIN TRIHYDRATE (PURIMOX) AS MANUFACTURED IN PUNJAB, INDIA FOR DSM SINOCHEM PHARMACEUTICALS NETHERLANDS B.V. LOGENGES HANDLE AS MANUFACTURED IN STATE-GUJARAT, INDIA LANSOPRAZOLE AS MANUFACTURED IN SHOUGUANG CITY, CHINA LEUPRORELIN ACETATE AS MANUFACTURED IN JEOLLANAM-DO, SOUTH KOREA LOSARTAN POTASSIUM USP (CRYSTALLINE) (ESUB) AS MANUFACTURED IN MUMBAI, INDIA BAZEDOXIFENE ACETATE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA TROSPIUM CHLORIDE [ROUTE CODE - ''TC''] AS MANUFACTURED IN ANDHRA PRADESH, INDIA CEFDINIR USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA PANCREATIC ENZYME PRODUCT (PEP) DELAYED RELEASE CAPSULES 750 U USPL AS MANUFACTURED IN MILAN, ITALY NON TOXIC FOOD/ PHARMA GRADE PLAIN AND PRINTED 3 PLY; 4 PLY LAMINATE AS MANUFACTURED IN NANI DAMAN, INDIA SYRINGE DOSING 0,5-5ML AS MANUFACTURED IN SAINT SULPICE, FRANCE; CASTELGUELFO (PR), ITALY; RIVANAZZANO (PV), ITALY BOTTLE PET 130 ML AS MANUFACTURED IN CASTELGUELFO (PR), ITALY; RIVANAZZANO (PV), ITALY; SAINT SULPICE, FRANCE SOLIFENACIN SUCCINATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA DEFERASIROX (ESUB) AS MANUFACTURED IN MYSORE DIST., INDIA CINACALCET HYDROCHLORIDE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA DULOXETINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA MEROPENEM FOR INJECTION BULK STERILE AS MANUFACTURED IN GUANGDONG, P. R. CHINA AMIODARONE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA ARGATROBAN HYDRATE AS MANUFACTURED IN SUZHOU, CHINA FOR ALP PHARM BEIJING CO., LTD IXABEPILONE AS MANUFACTURED IN TAOYUAN, TAIWAN Page

796

4Q2012EXCEL DMF# 25895 25896 25897 A 25898 25899 25900 A 25901 A 25902 A 25903 25904 25905 25906 A 25907 A 25908 A 25909 25910 25911 A A II II III 4/18/2012 5/8/2012 2/10/2012 TRIS PHARMA INC DR REDDYS LABORATORIES LTD SIDDHI FOILS II 4/2/2012 ALP PHARM BEIJING CO LTD II 3/30/2012 UNICHEM LABORATORIES LTD A A A II II II II 3/19/2012 3/1/2012 7/18/2012 6/19/2012 LAURUS LABS PRIVATE LTD QILU TIANHE PHARMACEUTICAL CO LTD SHILPA MEDICATE LTD GLAXOSMITHKLINE LLC II 3/23/2012 DR REDDYS LABORATORIES LTD II 4/2/2012 AUROBINDO PHARMA LTD A A II II III 3/21/2012 3/2/2012 2/29/2012 ALEMBIC PHARMACEUTICALS LTD API DIV CSPC INNOVATION PHARM CO LTD BOREALIS AG PRASUGREL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA PENTOXIFYLLINE AS MANUFACTURED IN SHIJIAZHUANG CITY, CHINA STATUS Type SUBMIT DATE A A II III II 3/19/2012 3/13/2012 3/31/2012 HOLDER LABORATORIOS IMPERIALES SA DE CV AMERICHEM INC SUBJECT BISMUTH SUBNITRATE AS MANUFACTURED IN MORELOS, MEXICO 62838-F50 WHITE COLORANT AS MANUFACTURED IN CUYAHOGA FALLS, OH

4Q2012

ZHEJIANG HISUN PHARMACEUTICAL CO LTD ANASTROZOLE (ESUB) AS MANUFACTURED IN TAIZHOU CITY, CHINA

BORMED HE9601-PH AS MANUFACTURED IN BURGHAUSEN, GERMANY FOR BOREALIS AG CLINDAMYCIN HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ATORVASTATIN CALCIUM (BUTYLATED HYDROXY ANISOLE PREMIX) AS MANUFACTURED IN ANDHRA PRADESH, INDIA BIMATOPROST AS MANUFACTURED IN ANDHRA PRADESH, INDIA PIPERACILLIN (NON-STERILE API) AS MANUFACTURED IN JINAN, CHINA ZOLEDRONIC ACID (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA VILANTEROL TRIFENATATE (ESUB) AS MANUFACTURED IN JURONG, SINGAPORE; HERTFORDSHIRE, UK FOR GLAXOSMITHKLINE LLC PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP (ESUB) AS MANUFACTURED IN DIST. RAIGAD, INDIA ALVIMOPAN DIHYDRATE (ESUB) AS MANUFACTURED IN SUZHOU, CHINA FOR ALP PHARM BEIJING CO LTD METHYLPHENIDATE ERCT (METHYLPHENIDATE ER CHEWABLE TABLETS (CII)) (ESUB) RIVASTIGMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ALUMINIUM FOIL PLAIN AND PRINTED, LAMINATED AND HEAT SEAL LACQUER (HSL) COATED FOR PHARMACEUTICAL TABLETS/ CAPSULES/ SOLID DOSAGE FORMS COLD FORM ALU ALU FOIL PLAIN AND PRINTED AS MANUFACTURED IN UTTARAKHAND, INDIA STERILE CONTRACT MANUFACTURING FACILITY (ESUB) AS MANUFACTURED IN GRAND RAPIDS, MI CEFEPIME FOR INJECTION USP (STERILE BULK) DRUG SUBSTANCE (ESUB) AS MANUFACTURED DISTRICT MOHALI (PUNJAB), INDIA ALBENDAZOLE AS MANUFACTURED IN MORELOS, MEXICO BOSENTAN MONOHYDRATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FESOTERODINE FUMARATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA 432619 YELLOW PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA AND HEATH, OH BRINZOLAMIDE, USP AS MANUFACTURED IN SARONNO (VARESE), ITALY AND BUCHAREST, ROMANIA FOR INDUSTRIALE CHIMICA S. R. L. 454113 RED PP MP AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA AND HEATH, OH 474268 GREEN PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA AND HEATH, OH 463728 BLUE PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA AND HEATH, OH 61918-CD1 WHITE COLORANT AS MANUFACTURED IN CUYAHOGA FALLS, OH

A 25912 A 25913 A 25914 25915 25916 25917 A 25918 A 25919 A 25920 A 25921 A 25922 A III 3/21/2012 AMERICHEM INC III 3/22/2012 AMPACET CORP III 3/22/2012 AMPACET CORP III 3/22/2012 AMPACET CORP II 3/28/2012 INDUSTRIALE CHIMICA SRL A A A II II II III 3/27/2012 4/2/2012 5/17/2012 3/22/2012 UQUIFA MEXICO SA DE CV CADILA HEALTHCARE LTD CADILA HEALTHCARE LTD AMPACET CORP II 5/5/2012 NECTAR LIFESCIENCES LTD V 10/22/2012 GRAND RIVER ASEPTIC MANUFACTURING

Page 797

4Q2012EXCEL DMF# 25923 A 25924 25925 25926 A 25927 25928 25929 25930 25931 25932 A 25933 A 25934 A 25935 25936 25937 25938 A 25939 25940 25941 25942 A 25943 A 25944 A 25945 A 25946 25947 A 25948 A 25949 A 25950 A 25951 25952 A A II III 3/30/2012 2/4/2012 III 3/16/2012 III 3/16/2012 ZHENGZHOU AOXIANG PHARMACEUTICAL PACKING CO LTD ZHENGZHOU AOXIANG PHARMACEUTICAL PACKING CO LTD SYNKEM SAS RAVIRAJ FOILS LTD III 4/6/2012 A II II 2/29/2012 5/17/2012 III 3/16/2012 ZHENGZHOU AOXIANG PHARMACEUTICAL PACKING CO LTD ZHUHAI UNITED LABORATORIES CO LTD THERAPEUTIC PROTEINS INTERNATIONAL LLC RACER TECHNOLOGY PTE LTD II 4/3/2012 LIPOID GMBH II 3/30/2012 NANOTHERAPEUTICS INC A A A II III III II 4/2/2012 6/6/2012 5/25/2012 3/30/2012 FARMAK AS SOOD PLASTICS PRIVATE LTD SOOD PLASTICS PRIVATE LTD NANOTHERAPEUTICS INC REGADENOSON AS MANUFACTURED IN OLOMOUC, CZECH REPUBLIC PLASTIC CLOSURES (ESUB) AS MANUFACTURED IN PUNJAB, INDIA PLASTIC BOTTLES (ESUB) AS MANUFACTURED IN PUNJAB, INDIA A A A II II II II 5/19/2012 5/29/2012 4/20/2012 6/6/2012 GLAND PHARMA LTD TOPCHEM PHARMACEUTICALS LTD TOPCHEM PHARMACEUTICALS LTD GLAND CHEMICALS PRIVATE LTD II 3/27/2012 SPLACK SA II 3/27/2012 FARMABIOS S P A P A A A A II II II II II 3/5/2012 4/3/2012 3/30/2012 4/2/2012 3/27/2012 *** PENDING FILING REVIEW *** TOMITA PHARMACEUTICAL CO LTD AARTI DRUGS LTD SHARON BIO MEDICINE LTD INDUSTRIALE CHIMICA SRL ERREGIERRE SPA A A II II II 3/30/2012 3/27/2012 3/30/2012 IRIX MANUFACTURING INC MEITEK TECHNOLOGY QINGDAO CO LTD AMRI RENSSELAER INC STATUS Type SUBMIT DATE III 3/28/2012 HOLDER SYMETAL ALUMINIUM FOIL INDUSTRY SA SUBJECT

4Q2012

LACQUERED BLISTER FOIL 20 - 25 MICRONS ALLOY 1200 AS MANUFACTURED IN ATHENS, GREECE LATANOPROST AS MANUFACTURED IN GREENVILLE, SC CHONDROITIN SULFATE CALCIUM AS MANUFACTURED IN QINGDAO CITY PENTOBARBITAL SODIUM, USP DRUG SUBSTANCE AS MANUFACTURED IN RENSSELAER, NEW YORK N.F. CALCIUM SILICATE (AS FLORITE R) AS MANUFACTURED IN TOKUSHIMA, JAPAN DICLOFENAC EPOLAMINE AS MANUFACTURED IN MAHARASHTRA, INDIA MOXIFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA LATANOPROST AS MANUFACTURED IN SARONNO (VARESE), ITALY N-[4-(TRIFLUOROMETHYL)BENZYL]-4-METHOXYBUTYRAMIDE AS MANUFACTURED IN SAN PAOLO D'ARGON (BERGAMO), ITALY BUSULFAN AS MANUFACTURED IN GROPELLO CAIROLI (PV), ITALY SILIPAC; CARBONPAC; MIXPAX; MOLPAC - DESICCANT BAGS AS MANUFACTURED IN ATIBAIA, SP BRAZIL TIGECYCLINE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ETHACRYNIC ACID (ESUB) AS MANUFACTURED IN CO SLIGO, REPUBLIC OF IRELAND BRETYLIUM TOSYLATE AS MANUFACTURED IN CO SLIGO, REPUBLIC OF IRELAND GEMCITABINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA

TRIAPINE DRUG SUBSTANCE AS MANUFACTURED IN LENEXA, KS FOR NANOTHERAPEUTICS, INC TRIAPINE INJECTION AS MANUFACTURED IN CHARLESTON , SC FOR NANOTHERAPEUTICS, INC LIPOID S 100 AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY; KOLN, GERMANY FOR LIPOID GMBH HALOGENATED BUTYL RUBBER STOPPER FOR INJECTION STERILE FREEZE-DRYING POWDER (BROMOBUTYL) AS MANUFACTURED IN DENGFENG CITY, CHINA CEFTRIAXONE SODIUM USP AS MANUFACTURED IN GUANGDONG, P. R. CHINA COMPOUND FILGRASTIM (G-CSF) CONCENTRATED SOLUTION, EP (ESUB) AS MANUFACTURED IN CHICAGO, IL OINTMENT APPLICATOR AS MANUFACTURED IN CHANGI SOUTH INDSTURIAL ESTATE, SINGAPORE HALOGENATED BUTYL RUBBER STOPPER FOR INJECTION (BROMOBUTYL) AS MANUFACTURED IN DENGFENG CITY, CHINA HALOGENATED BUTYL RUBBER STOPPER FOR INJECTION STERILE POWDER (BROMOBUTYL) AS MANUFACTURED IN DENGFENG CITY, CHINA QUETIAPINE FUMARATE AS MANUFACTURED IN CHENOVE, FRANCE ALU-ALU (COLD FORMING BLISTER) LAMINATE' AS MANUFACTURED IN GUJARAT, INDIA

Page 798

4Q2012EXCEL DMF# 25953 A 25954 A 25955 25956 25957 25958 25959 A 25960 A 25961 25962 25963 25964 25965 A 25966 25967 A 25968 A 25969 25970 A 25971 A 25972 25973 A 25974 A 25975 25976 A 25977 A 25978 25979 25980 25981 A 25982 A II 4/18/2012 A A A II IV II III 5/16/2012 5/5/2012 4/16/2012 4/13/2012 RELIANCE LIFE SCIENCES PVT LTD SUNIL HEALTHCARE LTD SYN TECH CHEM AND PHARM CO LTD NOLATO JAYCARE LTD V 4/17/2012 ACS DOBFAR SPA A IV II 4/10/2012 4/23/2012 III 4/17/2012 P II 4/16/2012 *** PENDING FILING REVIEW *** LABORATORIO CHIMICO INTERNAZIONALE SPA JAPAN POLYPROPYLENE CORP ETHACRYNIC ACID AS MANUFACTURED IN SEGRATE MI ITALY III 4/10/2012 SCG PERFORMANCE CHEMICALS CO LTD A II II 4/2/2012 4/12/2012 SEKISUI ALVEO AG INCELL CORP LLC II 3/15/2012 QILU TIANHE PHARMACEUTICAL CO LTD A IV IV 4/10/2012 4/12/2012 ILE PHARMACEUTICAL MATERIALS CO LTD SYMRISE INC COMPLETE FILM COATING SYSTEMS AS MANUFACTURED IN TIANJIN, CHINA P P A A II II III 3/6/2012 3/27/2012 4/12/2012 *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** SWATI SPENTOSE PRIVATE LTD PARABOLIC DRUGS LTD SEKISUI ALVEO AG LIDOCAINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA DEFERASIROX AS MANUFACTURED IN HARYANA, INDIA III 3/1/2012 EASTMAN CHEMICAL CO A A A A II II II II IV 3/29/2012 4/11/2012 4/10/2012 3/1/2012 4/10/2012 RAKS PHARMA PVT LTD SHASUN PHARMACEUTICALS LTD CF PHARMA LTD HUNAN YUXIN PHARMACEUTICAL CO LTD FONA INTERNATIONAL INC II 10/26/2011 FERMION OY STATUS Type SUBMIT DATE III 3/17/2012 HOLDER ASAHI RUBBER INC SUBJECT

4Q2012

RUBBER GASKET FOR DISPOSABLE SYRINGE AS MANUFACTURED IN FUKUSHIMA, PREFECTURE, JAPAN QUETIAPINE FUMARATE "ALTERNATIVE PROCESS" AS MANUFACTURED IN HANKO, FINLAND DOXYCYCLINE HYCLATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA PITAVASTATIN CALCIUM AS MANUFACTURED IN CUDDALORE, INDIA METHOTREXATE AS MANUFACTURED IN BUDAPEST, HUNGARY MOMETASONE FUROATE AS MANUFACTURED IN SHAOYANG CITY, CHINA 926.0701U FONATECH VANILLA TYPE FLAVOR, NAT (CFT) AS MANUFACTURED IN GENEVA, IL EASTMAN 168 NON-PHTHALATE PLASTICIZER PRODUCTION AS MANUFACTURED IN TEXAS CITY, TX

ALVEOLIT TA SRZ POLYMER FOAMS AS MANUFACTURED IN LUCERNE, SWITZERLAND

910009 EVOSPRAY NATURAL LIME FLAVOR WONF AS MANUFACTURED IN TETERBORO, NJ AND BRANCHBURG, NJ FOR SYMRISE INC TAZOBACTAM ACID (PROCESS V, NON-STERILE API) AS MANUFACTURED IN JINAN, CHINA ALVEOLIT TL SRZ AS MANUFACTURED IN LUCERNE, SWITZERLAND ZSOL:F, ZSOL:M AND ZSOL:MH BIOPROCESSING BUFFER FAMILY AS MANUFACTURED IN SAN ANTONIO, TX POLYPROPYLENE EL-PRO P655IM AS MANUFACTURED IN RAYONG, THAILAND FOR SCG PERFORMANCE CHEMICALS CO., LTD.

NOVATEC/WELNEX/WINTEC PP SERIES AS MANUFACTURED IN MIE, JAPAN FOR JAPAN POLYPROPYLENE CORPORATION HENRY H OTTENS MANUFACTURING CO INC ARTIFICIAL CHERRY FLAVOR #5578 AS MANUFACTURED IN PHILADELPHIA, PA AUROBINDO PHARMA LTD PALONOSETRON HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATION AS LOCATED IN TRIBIANO (MI), ITALY ERLOTINIB HYDROCHLORIDE (ESUB) AS MANUFACTURED IN NAVI MUMBAI, INDIA EMPTY HARD GELATIN CAPSULES AS MANUFACTURED IN RAJASTHAN, INDIA GRANISETRON BASE AS MANUFACTURED IN TAINAN CITY, TAIWAN

60, 75 AND 100ML HDPE WHITE ROUND BOTTLES AS MANUFACTURED IN NEWCASTLE UPON TYNE, ENGLAND ZHEJIANG GUOBANG PHARMACEUTICAL CO CLARITHROMYCIN USP AS MANUFACTURED IN ZHEJIANG, P. R. CHINA LTD Page 799

4Q2012EXCEL DMF# 25983 25984 25985 A 25986 25987 A 25988 25989 25990 25991 25992 A 25993 25994 25995 A 25996 A 25997 A 25998 A 25999 A 26000 A 26001 A 26002 A 26003 26004 26005 26006 26007 A 26008 26009 A 26010 26011 26012 A P P III 4/11/2012 CHROMA CORP *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** A III II 4/25/2012 3/21/2012 AIRSEC SAS QILU TIANHE PHARMACEUTICAL CO LTD SORB-IT PACKETS AS MANUFACTURED IN SAINT-MAMMES -FRANCE A A A P III 4/27/2012 II II II 4/19/2012 4/20/2012 8/12/2012 BACHEM SA PIRAMAL HEALTHCARE LTD SUZHOU APAC PHARMATECH CO LTD *** PENDING FILING REVIEW *** CONSOLIDATED BOTTLE CORP III 4/24/2012 AMPACET CORP III 4/23/2012 KAYGEE LOPAREX INDIA PVT LTD III 4/23/2012 KAYGEE LOPAREX INDIA PVT LTD III 4/23/2012 KAYGEE LOPAREX INDIA PVT LTD III 4/23/2012 KAYGEE LOPAREX INDIA PVT LTD III 4/23/2012 II 4/24/2012 ZHEJIANG JINHUA CONBA BIO PHARM CO LTD KAYGEE LOPAREX INDIA PVT LTD A N III 4/25/2012 II 5/7/2012 SRI KRISHNA PHARMACEUTICALS LTD NOT AN ASSIGNED NUMBER MITSUI CHEMICALS INC GLIPIZIDE USP AS MANUFACTURED IN MEDAK DIST, A.P, INDIA A A A A II II III IV II 4/23/2012 4/13/2012 4/25/2012 4/20/2012 4/28/2012 CQ INTERNATIONAL CO INC CAMBREX PROFARMACO MILANO SRL MPI RELEASE SYNKEM SAS A II II 4/20/2012 4/23/2012 RA CHEM PHARMA LTD HOVIONE FARMACIENCIA SA ITRACONAZOLE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA STATUS Type SUBMIT DATE A A II IV III 4/19/2012 4/23/2012 4/20/2012 HOLDER CHEMI SPA BHARAT STARCH INDUSTRIES SUBJECT

4Q2012

ZOLEDRONIC ACID HEMIPENTAHYDRATE AS MANUFACTURED IN FROSINONE, ITALY SODIUM STARCH GLYCOLATE USP AS MANUFACTURED IN YAMUNA NAGAR, INDIA

ST GOBAIN PERFORMANCE PLASTICS CORP SANI-TECH ULTRA 65 SILICONE TUBING AS MANUFACTURED IN TAUNTON, MA

MOMETASONE FUROATE MONOHYDRATE INHALATION GRADE AS MANUFACTURED IN LOURES, PORTUGAL DECITABINE JIANGSU, CHINA FOR CQ INTERNATIONAL CO. INC. EPINEPHRINE AS MANUFACTURED IN MILAN, ITALY RELEASE LINER 2-MIL PET C1S 15-0121 AS MANUFACTURED IN GREENFIELD, IN SODIUM STEARYL FUMARATE AS MANUFACTURED IN CHENOVE, FRANCE

ZHEJIANG HISUN PHARMACEUTICAL CO LTD FLUVASTATIN SODIUM AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

APEL APL6011T, APL6013T, APL6015T, APL6509T, AND APL8008T AS MANUFACTURED IN OSAKA, JAPAN ARIPIPRAZOLE AS MANUFACTURED IN ZHEJIANG PROVINCE RELEASE LINERS GRADE XL-TDP 62 YELLOW MADE WITH PLATINUM CURE CHEMISTRY ON YELLOW GLASSINE AS MANUFACTURED IN VILLAGE ATHAL SILVASSA, INDIA RELEASE LINERS GRADE XL-TDP 62 WHITE MADE WITH PLATINUM CURE CHEMISTRY ON WHITE GLASSINE AS MANUFACTURED IN VILLAGE ATHAL SILVASSA, INDIA RELEASE LINERS GRADE XL-TDP 80 MADE WITH PLATINUM CURE CHEMISTRY ON GLASSINE PAPER AS MANUFACTURED IN VILLAGE ATHAL SILVASSA, INDIA RELEASE LINERS GRADE XL-TDP 90 MADE WITH PLATINUM CURE CHEMISTRY ON GLASSINE PAPER AS MANUFACTURED IN VILLAGE ATHAL SILVASSA, INDIA RELEASE LINERS GRADE XL-TDP 120 MADE WITH PLATINUM CURE CHEMISTRY ON GLASSINE PAPER AS MANUFACTURED IN VILLAGE ATHAL SILVASSA, INDIA 455899 RED SMC PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA AND HEATH OH DEFERASIROX AS MANUFACTURED IN VIONNAZ,SWITZERLAND SULINDAC AS MANUFACTURED IN ANDHRA PRADESH, INDIA EWJPB, API AS MANUFACTURED IN WUJIANG CITY, CHINA 20ML NATURAL EUROPEAN DOSAGE CUP PP ROUND, GRADUATED (2.5ML TO 20ML) AS MANUFACTURED IN ONTARIO, CANADA FOR CONSOLIDATED BOTTLE CORPORATION

PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM (8:1) (STERILE API) AS MANUFACTURED IN JINAN, CHINA PC85234B BLACK COLOR CONCENTRATE AS MANUFACTURED IN MCHENRY, IL

Page 800

4Q2012EXCEL DMF# 26013 26014 A 26015 A 26016 A 26017 26018 26019 26020 A 26021 A 26022 A 26023 26024 A 26025 26026 26027 26028 26029 26030 A 26031 26032 26033 A 26034 A 26035 A 26036 26037 A 26038 26039 26040 A 26041 A 26042 A II 5/8/2012 RAKS PHARMA PVT LTD II 5/11/2012 JIANGSU HENGRUI MEDICINE CO LTD A A II II IV 5/9/2012 5/7/2012 5/8/2012 NEULAND LABORATORIES LTD BLOOMAGE FREDA BIOPHARM CO LTD SYMRISE INC A III II 5/4/2012 5/7/2012 LEVOSIL SPA JIANGSU HENGRUI MEDICINE CO LTD DESICCANT BAGS AS MANUFACTURED IN CHIUSA SAN MICHELE (TO), ITALY II 6/1/2012 AUROBINDO PHARMA LTD III 11/15/2010 INGENIA POLYMERS CORP A A II II II 4/27/2012 8/16/2012 5/23/2012 A A A A A II II II II II II 4/20/2012 5/8/2012 4/25/2012 5/5/2012 5/8/2012 5/8/2012 AVRA LABORATORIES PRIVATE LTD PROTEUS SA KONDUSKAR LABORATORIES PVT LTD DIVIS LABORATORIES LTD MAC CHEM PRODUCTS INDIA PVT LTD LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTD KREATIVE ORGANICS P LTD EXCELLA GMBH IPCA LABORATORIES LTD A II II 4/25/2012 5/3/2012 II 4/28/2012 ZHEJIANG NEO DANKONG PHARMACEUTICAL CO LTD MYLAN LABORATORIES LTD MSN LABORATORIES LTD II 5/2/2012 SYMBIOTEC PHARMALAB LTD A A A II II II II 5/2/2012 7/13/2012 5/22/2012 5/2/2012 HETERO DRUGS LTD SUN PHARMACEUTICAL INDUSTRIES LTD FRESENIUS KABI ONCOLOGY LTD SYMBIOTEC PHARMALAB LTD II 4/30/2012 III 5/1/2012 STATUS Type SUBMIT DATE A II III 6/1/2012 5/1/2012 HOLDER APICORE LLC BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG BOEHRINGER INGELHEIM MICROPARTS GMBH CERBIOS PHARMA SA SUBJECT ETHACRYNIC ACID USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA

4Q2012

CONTAINER CLOSURE FOR RESPIMAT AQUEOUS SOLUTIONS AS MANUFACTURED IN INGELHEIM AM RHEIN, GERMANY RESPIMAT INHALER FOR AQUEOUS SOLUTIONS AS MANUFACTURED IN DORTMUND, GERMANY (6S)-5-METHYLTETRAHYDROFOLIC ACID CALCIUM SALT AS MANUFACTURED IN BARBENGO/LUGANO, SWITZERLAND RIZATRIPTAN BENZOATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CAPECITABINE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA TEMSIROLIMUS (ESUB) AS MANUFACTURED IN WEST BENGAL, INDIA ETHINYL ESTRADIOL, USP (MICRONIZED) AS MANUFACTURED IN MADHYA PRADESH, INDIA ETHYNODIOL DIACETATE, USP (MICRONIZED) AS MANUFACTURED IN MADHYA PRADESH, INDIA ATORVASTATIN CALCIUM, NON-STERILE BULK DRUG SUBSTANCES AS MANUFACTURED IN TAIZHOU, CHINA DRONEDARONE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ESMOLOL HYDROCHLORIDE [ROUTE CODE: "EH"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA 10-HYDROXYCAMPTOTHECIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA NEOSAXITOXIN 200G/ML AS MANUFACTURED IN SANTIAGO, CHILE OXCARBAZEPINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA TELMISARTAN, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA CARBOPLATIN USP AS MANUFACTURED IN DISTRICT THANE, INDIA VANCOMYCIN HYDROCHLORIDE, LYOPHILIZED AS MANUFACTURED IN FUZHOU CITY, CHINA SALSALATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA TEMOZOLOMIDE (ESUB) AS MANUFACTURED IN FEUCHT, GERMANY CETIRIZINE HYDROCHLORIDE USP (CZ5 PROCESS) (ESUB) AS MANUFACTURED IN MADHYA PRADESH, INDIA INGENIA POLYMERS 1023 FILLED WHITE AS MANUFACTURED IN ONTARIO, CANADA; ALBERTA, CANADA; HOUSTON, TEXAS FOR INGENIA POLYMERS CORPORATION OLMESARTAN MEDOXOMIL (NON-STERILE DRUG SUBSTANCE) ANDHRA PRADESH, INDIA

MESNA USP, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU, CHINA BOSENTAN MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA SODIUM HYALURONATE (HA-P-0.5) AS MANUFACTURED IN JINAN CITY, P. R. OF CHINA 992583 NATURAL PEPPERMINT FLAVOR POWDER 605030 AS MANUFACTURED IN TETERBORO, NJ AND BRANCHBURG, NJ CYCLOPHOSPHAMIDE, USP, STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU, CHINA LINEZOLID AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 801

4Q2012EXCEL DMF# 26043 26044 26045 26046 A 26047 26048 A 26049 II 6/14/2012 A II II 6/8/2012 5/23/2012 UNIMARK REMEDIES LTD STATUS Type SUBMIT DATE P A A II II IV 5/15/2012 5/15/2012 5/3/2012 HOLDER *** PENDING FILING REVIEW *** HETERO LABS LTD HETERO DRUGS LTD FRUTAROM USA ETORICOXIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA SUBJECT

4Q2012

ZIPRASIDONE HYDROCHLORIDE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA NATURAL & ARTIFICIAL BLACKBERRY FLAVOR 3251351091.00 AS MANUFACTURED IN CORONA, CA CEFIXIME USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA

ZHEJIANG HISUN PHARMACEUTICAL CO LTD SIMVASTATIN (BHA ADDED) (ESUB) AS MANUFACTURED IN TAIZHOU CITY, CHINA ZHEJIANG HISUN PHARMACEUTICAL CO LTD DEMECLOCYCLINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN TAIZHOU CITY, CHINA

A 26050 A 26051 26052 26053 A 26054 A 26055 A 26056 A 26057 A 26058 26059 A 26060 A 26061 A 26062 26063 A 26064 26065 26066 A 26067 A 26068 A II 5/17/2012 TEVA PHARMACEUTICAL INDUSTRIES LTD II 5/18/2012 A A II II II 5/19/2012 5/11/2012 5/15/2012 A II II 5/2/2012 5/17/2012 KOPRAN LTD ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD INDO PHYTO CHEMICALS PRIVATE LTD PIRAMAL HEALTHCARE LTD NORTH CHINA PHARMACEUTICAL GROUP SEMISYNTECH CO LTD MAPRIMED SA II 5/9/2012 QILU PHARMACEUTICAL CO LTD EXEMESTANE (NON-STERILE, API) AS MANUFACTURED IN SHANDONG PROVINCE PR CHINA FOR QILU PHARMACEUTICAL CO LTD PREGABALIN AS MANUFACTURED IN MAHARASHTRA INDIA LCA45 AS MANUFACTURED IN ZHEJIANG CHINA LEVONORGESTREL USP AS MANUFACTURED IN UTTRAKHAND INDIA APREPITANT AS MANUFACTURED IN ANDHRA PRADESH INDIA AMOXICILLIN TRIHYDRATE (NON STERILE, API) AS MANUFACTURED IN HEBEI, P. R. CHINA ZOLEDRONIC ACID MONOHYDRATE (CODE 50787) AS MANUFACTURED IN BUENOS AIRES, ARGENTINA EZETIMIBE AS MANUFACTURED IN UTTAR PRADESH, INDIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD V 5/15/2012 A III II 4/23/2012 5/25/2012 SHREE NAINA PACKWELL INC AMPHASTAR NANJING PHARMACEUTICALS INC ACS DOBFAR SPA IV 5/14/2012 WILSHIRE TECHNOLOGIES INC II 8/31/2012 PRONOVA BIOPHARMA NORGE AS V 7/27/2012 UNIGENE LABORATORIES INC IV 5/16/2012 CAPSUGEL MANUFACTURING INC A A III II III 4/23/2012 5/14/2012 4/25/2012 SHREE NAINA POLYMERS INC SIEGFRIED LTD SUN PACKMET PRIVATE LTD PET BOTTLES AS MANUFACTURED IN HIMACHAL PRADESH, INDIA BUPRENORPHINE AS MANUFACTURED IN ZOFINGEN, SWITZERLAND PLAIN/PRINTED ALUMINIUM FOILS (STRIP/BLISTER) AS MANUFACTURED IN HIMACHAL PRADESH, INDIA COMPLIANCE IDENTIFIER CAPSULES AS MANUFACTURED IN GRAFFENSTADEN, FRANCE AND CAMBRIDGE, MA 3-O-LAUROYL-L-CARNITINE HYDROCHLORIDE (LLC) PRECLINICAL AND CLINICAL DATA (ESUB) OMEGA-3-ACID ETHYL ESTERS, (ESUB) AS MANUFACTURED IN SANDEFJORD, NORWAY AND KALUNDBORG, DENMARK PHYTOSQUENE AS MANUFACTURED IN CHARLES CITY, IOWA FOR WILSHIRE TECHNOLOGIES INC GLASS AMPOULES AND VIALS AS MANUFACTURED IN HIMACHAL PRADESH, INDIA SEMI-PURIFIED HEPARIN SODIUM (ESUB) AS MANUFACTURED IN JIANGSU CHINA STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS AS MANUFACTURE IN MILAN, ITALY - VALE ADDETTA PLANT - LYOPHILIZATION PLANT NO, 2 II 7/20/2012 ZHEJIANG HISUN PHARMACEUTICAL CO LTD MINOCYCLINE HYDROCHLORIDE (ESUB) AS MANUFACTUTED IN TAIZHOU CITY, CHINA

Page 802

4Q2012EXCEL DMF# 26069 A 26070 A 26071 26072 26073 26074 26075 A 26076 26077 26078 26079 A 26080 26081 26082 26083 26084 A 26085 26086 26087 26088 A 26089 A 26090 A 26091 26092 26093 26094 26095 A 26096 A 26097 A 26098 A 26099 A II 5/30/2012 HETERO DRUGS LTD II 6/8/2012 II 5/26/2012 ZHEJIANG TIANYU PHARMACEUTICAL CO LTD MEIJI SEIKA PHARMA CO LTD III 5/22/2012 P A A A IV IV IV III 4/23/2012 4/23/2012 4/23/2012 5/30/2012 *** PENDING FILING REVIEW *** GC CHEMIE PHARMIE LTD GC CHEMIE PHARMIE LTD GC CHEMIE PHARMIE LTD JIANGSU HUALAN NEW PHARMACEUTICAL MATERIAL CO LTD BORMIOLI ROCCO SPA BU PLASTICA III 5/30/2012 LUXFER GAS CYLINDERS III 5/21/2012 A A A II II II II 6/28/2012 5/24/2012 5/23/2012 5/16/2012 GLENMARK GENERICS LTD SIGMA ALDRICH MANUFACTURING LLC RAKS PHARMA PVT LTD ZHEJIANG JIANGBEI PHARMACEUTICAL CO LTD SMITHS MEDICAL ASD INC A A A A II II II II II 5/22/2012 5/14/2012 5/18/2012 5/24/2012 5/22/2012 HETERO DRUGS LTD CAYMAN PHARMA SRO NAGAOKA AND CO LTD SHASUN PHARMACEUTICALS LTD RAKS PHARMA PVT LTD A A A II II II II 5/21/2012 6/13/2012 5/22/2012 5/23/2012 SEQUENT SCIENTIFIC LTD WATSON PHARMA PRIVATE LTD MSN LABORATORIES LTD UNIT II HETERO DRUGS LTD A A A A II II II II II 5/31/2012 7/2/2012 5/31/2012 5/22/2012 5/18/2012 CADILA HEALTHCARE LTD CADILA HEALTHCARE LTD CADILA HEALTHCARE LTD HETERO DRUGS LTD CHEMWERTH INC FEBUXOSTAT API (ESUB) AS MANUFACTURED IN GUJARAT, INDIA OLANZAPINE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA ROSUVASTATIN CALCIUM API (ESUB) AS MANUFACTURED IN GUJARAT, INDIA II 6/15/2012 STATUS Type SUBMIT DATE IV 4/26/2012 HOLDER SUBJECT TIANJIN KAIWEI AND YONGLI UNITED WHITE MINERAL OIL AS MANUFACTURED IN TIANJIN, CHINA CHEMICAL CO LTD INTERNATIONAL MEDICATION SYSTEMS LTD HEPARIN SODIUM USP (ESUB) AS MANUFACTURED IN SOUTH EL MONTE, CA

4Q2012

MOXIFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ARSENIC TRIOXIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN FREIBURG, GERMANY FOR CHEMWERTH INC PRAZIQUENTEL AS MANUFACTURED IN KARNATAKA, INDIA OXYBUTYNIN BASE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA CAPECITABINE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA VALGANCICLOVIR HYDROCHLORIDE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR HETERO DRUGS LIMITED FENOFIBRATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA LATANOPROST AS MANUFACTURED IN NERATOVICE, CZECH REPUBLIC MENTHA OIL JP AS MANUFACTURED IN HYOGO, JAPAN TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN CUDDALORE, INDIA ATORVASTATIN CALCIUM STABILIZED AS MANUFACTURED IN ANDHRA PRADESH, INDIA DRONEDARONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA HYALURONIDASE AS MANUFACTURED IN ST LOUIS MO DEXLANSOPRAZOLE API AS MANUFACTURED IN ANDHRA PRADESH INDIA SIMVASTATIN AMMONIUM SALT (ALTERNATIVE PROCESS) AS MANUFACTURED IN TAIZHOU CITY, CHINA ENTERAL MEDICATION CASSETTE RESERVOIR AS MANUFACTURED IN TIJUANA MEXICO FOR SMITHS MEDICAL ASD INC COMPRESSED GAS CYLINDER PACKAGE (ALTERNATIVE PROCESS) AS MANUFACTURED IN GRAHAM, NC NOVOCOAT - HYPROMELLOSE USP-34 AS MANUFACTURED IN HUZHOU CITY, CHINA NOVODONE-CR CROSPOVIDONE USP-34 AS MANUFACTURED IN HUZHOU CITY, CHINA NOVODONE POVIDONE USP-34 AS MANUFACTURED IN HUZHOU CITY, CHINA BUTYL RUBBER STOPPERS COVERED WITH POLYSTER FILMS AS MANUFACTURED IN JIANGSU PROVINCE CHINA SPECIAL CHILD-PROOF CP O28 MM AS MANUFACTURED IN CASTELGUELFO (PR), ITALY; RIVANAZZANO (PV), ITALY; SAINT SULPICE, FRANCE FOR BORMIOLI ROCCO S.P.A. - B.U. PLASTICA MONTELUKAST BACKONE DIOL AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA ARBEKACIN FREE BASE DRUG SUBSTANCE (ME1100) AS MANUFACTURED IN IWATE, JAPAN AND KANAGAWA-KEN, JAPAN ELETRIPTAN HYDROBROMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 803

4Q2012EXCEL DMF# 26100 26101 26102 A 26103 A 26104 26105 26106 A 26107 26108 26109 A 26110 26111 A 26112 26113 26114 26115 26116 26117 26118 A 26119 A 26120 26121 26122 A 26123 26124 A 26125 26126 A 26127 26128 26129 A 26130 26131 A A II II 5/30/2012 6/6/2012 SARV BIO LABS PVT LTD HETERO DRUGS LTD A A II II II 6/5/2012 6/5/2012 6/5/2012 POSH CHEMICALS PRIVATE LTD DAIICHI FINE CHEMICAL CO LTD TRIFARMA SPA A II II 6/4/2012 6/4/2012 CRYSTAL PHARMA LTD TEVA PHARMACEUTICAL INDUSTRIES LTD A II III 5/28/2012 5/31/2012 SHARON BIO MEDICINE LTD AMCOR FLEXIBLES BURGDORF GMBH A P II 6/4/2012 IV 6/1/2012 IV 6/1/2012 THE NIPPON SYNTHETIC CHEMICAL INDUSTRY CO LTD FONA INTERNATIONAL INC *** PENDING FILING REVIEW *** HETERO LABS LTD A A A A A A II II II II II II III 5/31/2012 6/4/2012 5/28/2012 5/28/2012 6/4/2012 5/30/2012 6/1/2012 CAMBREX CHARLES CITY INC HETERO DRUGS LTD ZHUHAI UNITED LABORATORIES CO LTD ZHUHAI UNITED LABORATORIES CO LTD HETERO LABS LTD MYLAN LABORATORIES LTD KYODO PRINTING CO LTD A II II 5/31/2012 5/29/2012 A A II II II 5/31/2012 5/31/2012 5/30/2012 HUBEI HAOSUN PHARMACEUTICAL CO LTD CATALENT PHARMA SOLUTIONS LLC MINSHENG GROUP SHAOXING PHARMACEUTICAL CO LTD CATALENT PHARMA SOLUTIONS LLC ZHUHAI UNITED LABORATORIES CO LTD A C II II III 5/30/2012 9/30/2012 5/15/2012 OLON SPA EMCURE PHARMACEUTICALS LTD EQUISTAR CHEMICALS LP A LYONDELLBASELL INDUSTRIES CO ASENAPINE MALEATE AS MANUFACTURED IN RODANO (MI), ITALY ZOLMITRIPTAN (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA II 11/28/2012 TARO PHARMACEUTICAL INDUSTRIES LTD STATUS Type SUBMIT DATE A A II II II 5/30/2012 5/18/2012 9/7/2012 HOLDER HETERO DRUGS LTD BIOCON LTD AUROBINDO PHARMA LTD SUBJECT

4Q2012

SEVELAMER HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ORLISTAT AS MANUFACTURED IN BANGALORE, INDIA ESOMEPRAZOLE SODIUM (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA PROGUANIL HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN HAIFA BAY, ISRAEL

POLYPROPYLENE RESINS FOR MEDICAL APPLICATIONS AS MANUFACTURED IN PASADENA, TX AND WEST LAKE, LA FOR EQUISTAR CHEMICALS, LP, A LYONDELLBASELL INDUSTRIES COMPANY OXALIPLATIN AS MANUFACTURED IN HUBEI, CHINA WC3042-08P CAPSULE AS MANUFACTURED IN ST PETERSBURG FL ALENDRONATE SODIUM AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA WC3042-05, CAPSULE AS MANUFACTURED IN ST.PETERSBURG, FLORIDA POTASSIUM CLAVULANATE - MICROCRYSTALLINE CELLULOSE (1:1) AS MANUFACTURED IN GUANGDONG PR CHINA DICLOFENAC EPOLAMINE AS MANUFACTURED IN CHARLES CITY, IA TETRABENAZINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CEFUROXIME SODIUM USP AS MANUFACTURED IN GUANGDONG PR CHINA CEFOPERAZONE SODIUM USP AS MANUFACTURED IN GUANGDONG PR CHINA ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA ADEFOVIR DIPIVOXIL AS MANUFACTURED IN MAHARASHTRA, INDIA MOISTCATCH SERIES FOR MOISTURE ABSORBING MATERIAL AS MANUFACTURED IN IBARAKI JAPAN GOHSENOL EG AS MANUFACTURED IN KUMAMOTO JAPAN 825.0047U CHERRY FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA IL ATORVASTATIN CALCIUM TRIHYDRATE (FORM I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA TELMISARTAN USP AS MANUFACTURED MAHARASHTRA, INDIA COMPOUND PACKAGING MATERIAL PAPER/OPA/ALUMINIUM/ION AS MANUFACTURED IN BURGDORF, SWITZERLAND SOLIFENACIN SUCCINATE AS MANUFACTURED IN ZEJTUN, MALTA AZACITIDINE AS MANUFACTURED IN VERCELLY, ITALY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD SULFASALAZINE USP AS MANUFACTURED IN HYDERABAD, INDIA TRANEXAMIC ACID DRUG SUBSTANCE AS MANUFACTURED IN TOYAMA, JAPAN COLOCORTOLONE PIVALATE AS MANUFACTURED IN CERIANO LAGHETTO (MB) ITALY FOR THIOCOLCHICOSIDE AS MANUFACTURED IN PARDESH, INDIA GABAPENTIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA

Page 804

4Q2012EXCEL DMF# 26132 A 26133 26134 26135 26136 26137 26138 26139 26140 A 26141 A 26142 A 26143 A 26144 26145 26146 26147 A 26148 A 26149 A 26150 A 26151 A 26152 A 26153 26154 A 26155 26156 26157 A 26158 26159 26160 A A A II II II 5/28/2012 6/15/2012 6/11/2012 PARABOLIC DRUGS LTD CKD BIO CORP APTALIS PHARMATECH INC A A III II IV 5/23/2012 6/8/2012 6/13/2012 SIPPEX MSN LABORATORIES LTD GM CHEMIE PVT LTD PVC BAGS WITH CONNECTORS AS MANUFACTURED IN COURZIEU, FRANCE P III 5/23/2012 III 5/29/2012 CCC PLASTICS CANADA COLORS AND CHEMICALS LTD *** PENDING FILING REVIEW *** SIPPEX II 6/9/2012 MSN PHARMACHEM PVT LTD II 2/8/2012 APOTEX PHARMACHEM INC III 5/25/2012 MEGAPLAST GMBH II 6/12/2012 A C A II II II II 7/17/2012 7/2/2012 4/18/2011 6/8/2012 II 4/28/2012 ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD UBE INDUSTRIES LTD CADILA HEALTHCARE LTD SIGNA SA DE CV STANDARD CHEMICAL AND PHARMACEUTICAL CO LTD FARMABIOS S P A II 6/8/2012 NERPHARMA DS SRL BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE DRUG SUBSTANCE AS MANUFACTURED IN MILAN, ITALY OLMESARTAN MEDOXOMIL AS MANUFACTURED IN ZHEJIANG, CHINA III 6/8/2012 A P A A A A P III 5/31/2012 II II II II 6/5/2012 6/7/2012 6/8/2012 6/27/2012 II 5/14/2012 STATUS Type SUBMIT DATE II 5/25/2012 HOLDER SHANDONG XINHUA PHARMACEUTICAL CO LTD BETTS INDIA PRIVATE LTD *** PENDING FILING REVIEW *** POLYONE CORP HETERO DRUGS LTD SCI PHARMTECH, INC. ALEMBIC PHARMACEUTICALS LTD API DIV *** PENDING FILING REVIEW *** CC10161654XX (AMBER ARCH) AS MANUFACTURED IN ELK GROVE VILLAGE, IL LACOSAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CYCLOPHOSPHAMIDE AS MANUFACTURED IN TAOYUAN, TAIWAN SUBJECT AMLODIPINE BESYLATE AS MANUFACTURED IN SHANDONG, PR CHINA LAMINATED TUBES USED FOR PACKAGING AS MANUFACTURED IN GOA, INDIA

4Q2012

DARIFENACIN HYDROBROMIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA

ST GOBAIN PERFORMANCE PLASTICS CORP POLYESTER FILM C/1/S WITH 4130 SILICONE RELEASE COATING, POLYESTER FILM C/1/S WITH 4140 SILICONE RELEASE COATING AS MANUFACTURED IN WORCESTER, MASSACHUSETTS COLORS FOR PLASTICS INC THERMOPLASTIC RESIN COLORANT MASTERBATCHES B24338 BLUE 286C, E16055 GREEN 369C AND W05255 WHITE AS MANUFACTURED IN ELK GROVE VILLAGE, ILLINOS

DS-1442B DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN YAMAGUCHI, JAPAN PHENTERMINE HYDROCHLORIDE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA GEMFIBROZIL USP (GEA PROCESS) AS MANUFACTURED IN TOLUCA, MEXICO RILUZOLE AS MANUFACTURED IN TAINAN CITY, TAIWAN FLUNISOLIDE HEMIHYDRATE (MICRONIZED) AS MANUFACTURED IN GROPELLO CAIROLI (PV) ITALY AIRLESS PUMP DISPENSERS AS MANUFACTURED IN VILLINGEN SCHWENNINGEN GERMANY ROSUVASTATIN CALCIUM (ROS) AS MANUFACTURED IN BRANTFORD ONTARIO, CANADA AND TOLUCA ESTADO DE, MEXICO FOR APOTEX PHARMACHEM INC MILNACIPRAN HYDROCHLORIDE [ROUTE CODE-"MR"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA WHITE MB50-936 POLYPROPYLENE COLOUR CONCENTRATE AS MANUFACTURED IN ONTARIO, CANADA POLYPROPYLENE BAGS WITH CONNECTORS AS MANUFACTURED IN COURZIEU, FRANCE

AMBRISENTAN [ROUTE CODE - "AB"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA CELLULOSE ACETATE PHTHALATE (CELLACEFATE) USP AS MANUFACTURED IN MAHARASHTRA, INDIA BOSENTAN MONOHYDRATE AS MANUFACTURED IN HARYANA, INDIA RIFAMYCIN O, NON-STERILE API AS MANUFACTURED IN KYUNGGI-DO, SOUTH KOREA TENOFOVIR RAPIDLY DISINTEGRATING TABLETS, 40 MG AS MANUFACTURED IN VANDALIA, OHIO Page

805

4Q2012EXCEL DMF# 26161 A 26162 A 26163 A 26164 A 26165 A 26166 A 26167 26168 26169 A 26170 26171 26172 A 26173 26174 26175 A 26176 A 26177 A 26178 26179 A 26180 26181 26182 A 26183 26184 A 26185 A 26186 26187 26188 26189 A A P A IV II 6/29/2012 6/29/2012 V 6/26/2012 LONZA AG *** PENDING FILING REVIEW *** FONA INTERNATIONAL INC FRESENIUS KABI ANTI INFECTIVES SRL POTENT COMPOUND PRODUCTION (PCP) FACILITY AT LONZA VISP SITE II 6/28/2012 HETERO LABS LIMITED A II II 6/26/2012 6/28/2012 CRYSTAL PHARMA SAU ASENCE PHARMA PRIVATE LTD A A II II II 6/22/2012 6/22/2012 7/11/2012 A II II 6/22/2012 6/25/2012 II 7/13/2012 ORCHID CHEMICALS AND PHARMACEUTICALS LTD HETERO DRUGS LTD DISHMAN PHARMACEUTICALS AND CHEMICALS LTD DELTA BIOTECH SA DELTA BIOTECH SA GLOPEC INTERNATIONAL INC II 6/28/2012 UNIMARK REMEDIES LTD A P V 7/16/2012 II 10/26/2012 SUN PHARMACEUTICAL INDUSTRIES LTD *** PENDING FILING REVIEW *** CORDEN PHARMA LATINA SPA P P II 6/7/2012 *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** CHONGQING PHAR SCIN CO LTD A P V 6/15/2012 II 7/7/2012 CADILA PHARMACEUTICALS LTD *** PENDING FILING REVIEW *** ACS DOBFAR SPA II 6/19/2012 III 6/15/2012 ZHONGSHAN CITY CONSTRONG MEDICAL PACKAGING MATERIAL CO LTD SYMBIOTEC PHARMALAB LTD II 6/7/2012 II 6/11/2012 II 6/11/2012 STATUS Type SUBMIT DATE II 6/11/2012 HOLDER APTALIS PHARMATECH INC SUBJECT

4Q2012

EMTRICITABINE RAPIDLY DISINTEGRATING TABLETS, 40 MG AS MANUFACTURED IN VANDALIA, OHIO APTALIS PHARMATECH INC EMTRICITABINE AND TENOFOVIR RAPIDLY DISINTEGRATING TABLETS, 40 MG/40 MG AS MANUFACTURED IN VANDALIA, OHIO ZHEJIANG JIUZHOU PHARMACEUTICAL CO VENLAFAXINE HYDROCHLORIDE CRYSTALLINE FORM B (VERSION NUMBER: 1) AS LTD MANUFACTURED IN ZHEJIANG, CHINA CENTAUR PHARMACEUTICALS PRIVATE LTD ES-ZOPICLONE AS MANUFACTURED IN MAHARASHTRA, INDIA NON-PVC MEDICAL PACKING FILM AS MANUFACTURED IN GUANGDONG, CHINA TESTOSTERONE ENANTHATE, USP AS MANUFACTURED IN MADHYA PRADESH (M.P.), INDIA VALSARTAN USP (PROCESS 2) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA STERILE FINISHED PRODUCTS AS STERILE PROCESSING OPERATIONS, AND LOCATED IN MILANO, ITALY- VIALE ADDETTA PLANT- LYOPHILIZATION PLANT NO.1

HYDROTALCITE NON STERILE, DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING CITY, P.R. CHINA FESOTERODINE FUMARATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA ASEPTIC ONCOLOGICAL FACILITY (ESUB) AS MANUFACTURED IN SERMONETA (LATINA), ITALY NITROFURANTOIN ANHYDROUS USP (MACROCRYSTALS) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA ALMOTRIPTAN MALATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA RITONAVIR PREMIX AS MANUFACTURED IN ANDHRA PRADESH, INDIA CETIRIZINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA TRAVOPROST AS MANUFACTURED IN BUENOS AIRES, ARGENTINA LATANOPROST AS MANUFACTURED IN BUENOS AIRES, ARGENTINA ACITRETIN (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR GLOPEC INTERNATIONAL INC ETHINYL ESTRADIOL AS MANUFACTURED IN VALLADOLID, SPAIN AMPHOTERICIN B USP [ORAL GRADE] AS MANUFACTURED IN GUJARAT, INDIA FOR ASENCE PHARMA PRIVATE LIMITED ESCITALOPRAM OXALATE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

825.0062U N-C CHERRY BERRY FLAVOR, ART AS MANUFACTURED IN GENEVA, IL HETACILLIN POTASSIUM STERILE AS MANUFACTURED IN CERNUSCO SUL NAVIGLIO (MI), ITALY AND VILLADOSE (RO), ITALY

Page 806

4Q2012EXCEL DMF# 26190 A 26191 26192 26193 26194 A 26195 26196 26197 A 26198 26199 26200 A 26201 A 26202 26203 A 26204 A 26205 26206 26207 26208 26209 26210 A 26211 26212 26213 A 26214 26215 26216 A 26217 26218 A 26219 A 26220 A IV 7/5/2012 UNGERER AND CO IV 7/11/2012 FUJI SILYSIA CHEMICAL LTD A II II 7/12/2012 7/12/2012 HETERO DRUGS LTD DELAVAU LLC A P III 9/18/2012 II 11/9/2012 LUPIN LTD *** PENDING FILING REVIEW *** EMPHASYS INDUSTRIAL A A IV IV II 7/5/2012 7/5/2012 8/5/2012 TAKASAGO INTERNATIONAL CORP TAKASAGO INTERNATIONAL CORP AVA, INC. A A A A A II II II II II II 6/29/2012 7/10/2012 7/10/2012 6/29/2012 10/23/2012 9/27/2012 PCI SYNTHESIS HETERO DRUGS LTD HETERO LABS LTD JARI PHARMACEUTICAL CO LTD GLENMARK GENERICS LTD CADILA PHARMACEUTICALS LTD II 7/9/2012 HETERO DRUGS LTD A II III 7/5/2012 3/26/2012 III 6/8/2012 A A II V II 7/10/2012 6/28/2012 7/3/2012 CTX LIFE SCIENCES PVT LTD PIRAMAL HEALTHCARE UK LTD A A II IV IV 7/2/2012 7/3/2012 8/16/2012 A A A II II III II 6/29/2012 7/3/2012 6/25/2012 6/25/2012 CRYSTAL PHARMA SAU AARTI DRUGS LTD AMPACET CORP WATERSTONE PHARMACEUTICALS HUBEI CO LTD NEULAND LABORATORIES LTD JSR LIFE SCIENCES CORP LIFECELL INTERNATIONAL PRIVATE LTD STATUS Type SUBMIT DATE II 6/14/2012 HOLDER FIS FABBRICA ITALIANA SINTETICI SPA SUBJECT

4Q2012

SOLIFENACIN SUCCINATE AS MANUFACTURED IN ALTE DI MONTECCHIO MAGGIORE, ITALY CLOBETASOL PROPIONATE MICRONIZED AS MANUFACTURED IN VALLADOLID, SPAIN PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA 11078-E WHITE PE MB AS MANUFACTURED IN MESSANCY, BELGIUM LEVETIRACETAM AS MANUFACTURED IN HUBEI PROVINCE, CHINA PALIPERIDONE PALMITATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA STYRENE ISOPRENE BLOCK COPOLYMER AS MANUFACTURED IN IBARAKI, JAPAN DMSO 55%W/V DEXTRAN-40 5%W/V SOLUTION (ESUB) AS MANUFACTURED IN CHENNAI, INDIA OLMESARTAN MEDOXOMIL (ESUB) AS MANUFACTURED IN GUJARAT, INDIA GRANGEMOUTH SITE (SUITE 5)

UNION QUIMICO FARMACEUTICA SA UQUIFA LINEZOLID AS MANUFACTURED IN BARCELONA, SPAIN SA AMI POLYMERS PVT LTD SILICON TUBES & BRAIDED HOSES (PLATINUM CURED & PEROXIDE CURED) AS MIRA ROAD AND SILVASSA, INDIA SICHUAN XIELI PHARMACEUTICAL CO LTD ANASTROZOLE AS MANUFACTURED IN SICHUAN, CHINA REXAM HEALTHCARE OFFRANVILLE SAS EYE DROPPERS SETS (10ML LDPE BOTTLE+ LDPE NOZZLE + PP CAPS) AS MANUFACTURED IN OFFRANVILLE, FRANCE DORZOLAMIDE HYDROCHLORIDE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA PCI-114234 AS MANUFACTURED IN NEWBURYPORT, MASSACHUSETTS SEVELAMER CARBONATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA PAZOPANIB HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA TORSEMIDE AS MANUFACTURED IN JIANGSU, CHINA RUFINAMIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA RUPATADINE FUMARATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA CHERRY MICRON OT-22685 AS MANUFACTURED IN SHIZAUOKA, JAPAN CHERRY FLAVOR OT-83853 AS MANUFACTURED IN KANAGAWA, JAPAN CHLORHEXIDINE GLUCONATE 20% SOLUTION, USP (ESUB) AS MANUFACTURED IN WILLOWBROOK, IL ATORVASTATIN CALCIUM AMORPHOUS (ESUB) AS MANUFACTURED IN GUJRAT, INDIA CDM-HALER (ESUB) AS MANUFACTURED IN BOITUVA/SP, BRAZIL FOR EMPHASYS INDUSTRIAL FEBUXOSTAT (FORM-H1) AS MANUFACTURED IN ANDHRA PRADESH, INDIA CALCIUM CARBONATE/MAGNESIUM HYDROXIDE GRANULATION AS MANUFACTURED IN PHILADELPHIA, PENNSYLVANIA SYNTHETIC AMORPHOUS SILICA PRODUCTS - SYLYSIA/ADSOLIDER AS MANUFACTURED IN MIYAZAKI-KEN, JAPAN ARTIFICIAL STRAWBERRY FLAVOR FV-3179 AS MANUFACTURED IN BETHLEHEM, PENNSYLVANIA

Page 807

4Q2012EXCEL DMF# 26221 26222 26223 26224 A 26225 A 26226 A 26227 A 26228 A 26229 A 26230 A 26231 A 26232 A 26233 26234 A 26235 26236 26237 26238 A 26239 A 26240 A 26241 26242 26243 A 26244 26245 A 26246 26247 A A II II 7/31/2012 8/10/2012 P II 7/23/2012 *** PENDING FILING REVIEW *** DISHMAN PHARMACEUTICALS AND CHEMICALS LTD CTX LIFE SCIENCES PVT LTD HEBEI JIHENG GROUP PHARMACEUTICAL CO LTD TRANS CHLOROATOVAQUONE AS MANUFACTURED IN GUJARAT, INDIA PREGABALIN (ESUB) AS MANUFACTURED IN GUJARAT, INDIA ACETAMINOPHEN (ESUB) AS MANUFACTURED IN HENGSHUI CITY, CHINA A A II II III 9/4/2012 7/17/2012 7/23/2012 II 2/28/2012 SHANDONG LONGLIVE BIO TECHNOLOGY CO LTD ALEMBIC PHARMACEUTICALS LTD API DIV LAURUS LABS PRIVATE LIMITED KRISHNA FOILS II 8/1/2012 A A A II II III II 7/13/2012 7/12/2012 7/19/2012 7/6/2012 APOTEX PHARMACHEM INDIA PVT LTD CHEMAGIS LTD MITSUI CHEMICALS INC QILU ANTIBIOTICS PHARMACEUTICAL CO LTD AUROBINDO PHARMA LTD P III 6/12/2012 *** PENDING FILING REVIEW *** ESS DEE ALUMINIUM LTD IV 7/13/2012 ILE PHARMACEUTICAL MATERIALS CO LTD IV 7/13/2012 II 6/22/2012 ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD ILE PHARMACEUTICAL MATERIALS CO LTD II 7/31/2012 II 10/26/2012 UNIV TEXAS MD ANDERSON CANCER CENTER APOGEPHA ARZNEIMITTEL GMBH III 7/10/2012 TOPPAN PRINTING CO LTD II 11/28/2012 TARO PHARMACEUTICAL INDUSTRIES LTD II 8/16/2012 SANOFI PASTEUR INC STATUS Type SUBMIT DATE P A A III II II 6/25/2012 7/16/2012 12/17/2012 HOLDER *** PENDING FILING REVIEW *** AMPACET CORP ASYMCHEM LABORATORIES INC IROKO PHARMACEUTICALS LLC 100664-E MOLD RELEASE PE MB AS MANUFACTURED IN BELGIUM, EUROPE DEXMEDETOMIDINE HYDROCHLORIDE AS MANUFACTURED IN TIANJIN, CHINA SUBJECT

4Q2012

ZORVOLEX ( TM) (DICLOFENAC SUBMICRON PARTICLE) CAPSULES 18 MG AND 35 MG (ESUB) AS MANUFACTURED IN KANSAS CITY, MO FOR IROKO PHARMACEUTICALS, LLC PEGYLATED RECOMBINANT ANTI-PSEUDOMONAS AERUGINOSA PCRV FAB' ANTIBODY (KB001-A) DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN BERKSHIRE, UNITED KINGDOM FOR SANOFI PASTEUR, INC OXICONAZOLE NITRATE, MICRONIZED (ESUB) AS MANUFACTURED IN HAIFA BAY, ISRAEL A PET/SILICONE LINER FOR TRANSDERMAL DRUG DELIVERY PATCHES AS MANUFACTURED IN FUKUOKA, JAPAN 3'-DEOXY-3'-[F-18] FLUOROTHYMIDINE (18F-FLT) (ESUB) AS MANUFACTURED IN HOUSTON, TX P4 (ESUB) AS MANUFACTURED IN RADEBEUL, GERMANY AND DRESDEN, GERMANY FOR APOGEPHA ARZNEIMITTEL GMBH EPROSARTAN MESYLATE AS MANUFACTURED IN ZHEJIANG, CHINA ETHYLCELLULOSE AQUEOUS DISPERSION (PROFESSIONAL) (NON-STERILE, BULK FORM) AS MANUFACTURED IN TIANJIN , CHINA ETHYLCELLULOSE AQUEOUS DISPERSION (REGULAR) (NON-STERILE, BULK FORM) AS MANUFACTURED IN TIANJIN , CHINA NON TOXIC FOOD CONTACT GRADE SOFT ALUMINIUM HOUSE FOIL (PLAIN & PRINTED) AS MANUFACTURED IN NANI DAMAN (U.T.), INDIA CABERGOLINE USP AS MANUFACTURED IN BANGALOR, INDIA ROTIGOTINE AS MANUFACTURED IN JINAN CITY, CHINA FOR CHEMAGIS LTD TAFMER A-0585X AS MANUFACTURED IN CHIBA, JAPAN PACA INTERMEDIATE AS MANUFACTURED IN JINAN, CHINA ESOMEPRAZOLE MAGNESIUM DIHYDRATE USP (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA XYLO-OLIGOSACCHARIDES AS MANUFACTURED IN YUCHENG CITY, P.R. OF CHINA FESOTERODINE FUMARATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA EFAVIRENZ USP (PROCESS-2) AS MANUFACTURED IN ANDHRA PRADESH, INDIA PHARMACEUTICALS FOILS & FLEXIBLE PACKAGING PRODUCTS AS MANUFACTURED IN AHMEDABAD INDIA

Page 808

4Q2012EXCEL DMF# 26248 A 26249 26250 26251 26252 26253 A 26254 26255 A 26256 26257 A 26258 A 26259 A 26260 A 26261 26262 A 26263 26264 A 26265 A 26266 A 26267 26268 A 26269 26270 26271 A 26272 26273 A 26274 A 26275 A II 10/31/2012 III 8/1/2012 BEIJING AUSTAR HANSEN PACKAGING TECHNOLOGY LTD LUPIN LTD TWIST OFF PORT AS MANUFACTURED IN BEIJING CITY, CHINA FESOTERODINE FUMARATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA A II III 8/1/2012 7/23/2012 A A II II II 7/30/2012 7/21/2012 8/1/2012 A II II 7/30/2012 7/20/2012 VUAB PHARMA AS QILU ANTIBIOTICS LINYI PHARMACEUTICAL CO LTD PROCOS SPA MSN PHARMACHEM PVT LTD CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD GALAXY SURFACTANTS LTD OH SUNG PLASTIC CO LTD OXALIPLATIN AS MANUFACTURED IN BRNO CEZCH REPUBLIC II 7/31/2012 III 8/1/2012 P II 8/16/2012 A III II 7/18/2012 7/25/2012 III 7/27/2012 III 7/27/2012 II 7/30/2012 HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO LTD SHENG ZOU RUBBER AND PLASTICS SUZHOU CO LTD SHENG ZOU RUBBER AND PLASTICS SUZHOU CO LTD NIPRO STERILE GLASS GERMANY AG IOL CHEMICALS AND PHARMACEUTICALS LTD *** PENDING FILING REVIEW *** SANOFI PASTEUR INC P II 8/12/2012 *** PENDING FILING REVIEW *** BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO., LTD. A II II 7/27/2012 7/26/2012 A A C A II II II II II 7/26/2012 10/26/2012 9/10/2012 7/23/2012 7/10/2012 STATUS Type SUBMIT DATE II 8/10/2012 HOLDER HEBEI JIHENG GROUP PHARMACEUTICAL CO LTD AARTI INDUSTRIES LTD RANBAXY LABORATORIES LTD CADILA HEALTHCARE LTD SICHUAN XIELI PHARMACEUTICAL CO LTD BEIJING GEYUAN TIANRUN BIO TECH CO LTD SINTENOVO SA DE CV INCELL CORP LLC SUBJECT

4Q2012

ACETAMINOPHEN DC 90% (ESUB) AS MANUFACTURED IN HENGSHUI CITY, CHINA LOTEPREDNOL ETABONATE AS MANUFACTURED IN MAHARASHTRA, INDIA LACOSAMIDE (ESUB) AS MANUFACTURED IN PUNJAB, INDIA SILODOSIN (ESUB) AS MANUFACTURED IN GUJARAT, INDIA LETROZOLE AS MANUFACTURED IN SICHUAN, CHINA TRYPSIN AS MANUFACTURED IN BEIJING CITY PALIPERIDONE AS MANUFACTURED IN ESTADO DE MEXICO ZTM: A1 AND ZTM: A2 DEFINED CULTURE MEDIA AS MANUFACTURED IN SAN ANTONIO, TX 2-AMINO-1,9-DIHYDRO-9-[(1S,3R,4S)-4-(BENZYLOXY)-3-(BENZYLOXYMETHYL)-2METHYLENE CYCLOPENTYL]-6H-PURINE-6-ONE(ET1) (ESUB) AS MANUFACTURED IN JIANGSU, CHINA ENOXAPARIN SODIUM AS MANUFACTURED IN HEBEI PROVINCE, P.R. CHINA FORMULATION C25(C25B) RUBBER STOPPER AS MANUFACTURED IN SUZHOU CITY, CHINA FORMULATION C31(C31B) AS MANUFACTURED IN SUZHOU CITY, CHINA STERILE TUBULAR GLASS VIALS AS MANUFACTURED IN MUNNERSTADT, GERMANY OMEPRAZOLE AS MANUFACTURED IN PUNJAB, INDIA

PEGYLATED RECOMBINANT ANIT-PSEUDOMONAS AERUGINOSA PCRV FAB' ANTIBODY (KB001-A) DRUG PRODUCT (ESUB) AS MANUFACTURED IN VITRY-SUR-SEINE CEDEX, FRANCE AND ONTARIO, CANADA FOR SANOFI PASTEUR, INC.

BRIGHTWOOD PHARMMED CONSUMABLE MULTILAYER TUBE (MF800) AS MANUFACTURED IN BEIJING, P.R. CHINA BEIJING LTD PHARMACEUTICAL WORKS POLPHARMA SA CARBAMAZEPINE AS MANUFACTURED IN GDANSKI, POLAND

WARFARIN SODIUM (NON-STERILE, API) AS MANUFACTURED IN LINYI COUNTY, P.R. CHINA MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN CAMERI, ITALY LACOSAMIDE [ROUTE CODE-"LD"] AS MANUFACTURED IN ANDHRA PRADESH, INDIA ETHYL ICOSAPENTATE AS MANUFACTURED IN NEW TAIPEI CITY, TAIWAN OCTINOXATE AS MANUFACTURED IN MAHARASHTRA, INDIA CONTAINER & CLOSURE AS MANUFACTURED IN CHUNGCHEONGBUK-DO, SOUTH KOREA

Page 809

4Q2012EXCEL DMF# 26276 26277 26278 26279 A 26280 A 26281 26282 26283 26284 26285 26286 A 26287 A 26288 A 26289 A 26290 26291 26292 26293 A 26294 26295 A 26296 A 26297 26298 26299 26300 26301 A 26302 A 26303 26304 A 26305 A II 8/3/2012 A II II 8/13/2012 7/30/2012 HETERO DRUGS LTD ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD II 8/8/2012 SICHUAN XIELI PHARMACEUTICAL CO LTD A A A A II V II IV II 8/2/2012 8/9/2012 8/22/2012 7/24/2012 8/8/2012 FIS FABBRICA ITALIANA SINTETICI SPA VALDEPHARM CIPLA LTD SEPPIC SA TOMITA PHARMACEUTICAL CO LTD III 8/9/2012 CONSOLIDATED BOTTLE CORP P II 8/9/2012 *** PENDING FILING REVIEW *** HEC PHARM USA INC P A P III 8/9/2012 II 7/26/2012 *** PENDING FILING REVIEW *** FARMABIOS S P A *** PENDING FILING REVIEW *** AMCOR FLEXIBLES GENT II 9/7/2012 JIANSHI YUANTONG BIOENGINEERING CO LTD HUNAN YUANTONG PHARMACEUTICAL CO LTD MSN ORGANICS PVT LTD A A A A A II II III III III III 5/24/2012 8/14/2012 8/1/2012 8/1/2012 7/18/2012 7/17/2012 II 8/2/2012 STATUS Type SUBMIT DATE P A A III IV IV 7/17/2012 7/27/2012 7/31/2012 HOLDER *** PENDING FILING REVIEW *** OG CORP DINESH REMEDIES LTD DOW CORNING CORP EMBOSSED PET FILM AS MANUFACTURED IN SHIGA-PREF., JAPAN HARD GELATIN CAPSULE SHELLS AS MANUFACTURED IN GUJARAT, INDIA SUBJECT

4Q2012

DOW CORNING SILASTIC BIOMEDICAL GRADE ETR ELASTOMERS AS MANUFACTURED IN HEMLOCK, MICHIGAN SHANGHAI AJINOMOTO AMINO ACID CO LTD L-LYSINE MONOHYDROCHLORIDE AS MANUFACTURES IN SHANGHAI, PEOPLE'S REPUBLIC OF CHINA MAC CHEM PRODUCTS INDIA PVT LTD CYTARABINE USP AS MANUFACTURED IN BOISAR, INDIA RELIANCE LIFE SCIENCES PVT LTD BULK PACKAGING LINERS PVT LTD BULK PACKING LINERS PVT LTD NOLATO JAYCARE LTD NOLATO JAYCARE LTD BORTEZOMIB (ESUB) AS MANUFACTURED IN NAVI MUMBAI, INDIA PE FILM 40 FEET CONTAINER LINER AS MANUFACTURED IN KARNATAKA, INDIA PE FILM 20 FEET CONTAINER LINER AS MANUFACTURED IN KARNATAKA, INDIA OVERCAP AS MANUFACTURED IN NEWCASTLE UPON TYNE ENGLAND 20ML MK2 POLYETHYLENE WHITE ROUND BOTTLE AS MANUFACTURED IN NEWCASTLE UPON TYNE, ENGLAND

FEBUXOSTAT [ROUTE CODE FUG] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA EXEMESTANE MICRONIZED AS MANUFACTURED IN GROPELLO CAIROLI, ITALY AF GENT EXTRUDED FILMS AND LAMINATES FOR PACKAGING AS MANUFACTURED IN GENT, BELGIUM LEVOFLOXACIN NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN HUBEI PROVINCE CHINA 120ML WHITE LDPE FLAT OVAL BOTTLE 20/410 AS MANUFACTURED IN CONCORD ONTARIO, CANADA FOR CONSOLIDATED BOTTLE CORPORATION OLOPATADINE HCL AS MANUFACTURED IN VICENZA, ITALY STERILIZATION PROCESS VALIDATION FOR USE IN CEDEX, FRANCE ABACAVIR SULFATE USP (ESUB) AS MANUFACTURED IN PUNE MAHARASHTRA, INDIA MONTANOX 80 PPI AS MANUFACTURED IN CASTRES CEDEX FRANCE U.S.P. MAGNESIUM SULFATE HEPTAHYDRATE AS MANUFACTURED IN NARUTO, TOKUSHIMA JAPAN URSODEOXYCHOLIC ACID AS MANUFACTURED IN PENGZHOU CITY,SICHUAN PROVINCE, CHINA LOPINAVIR AMORPHOUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA LAROPIPRANT AS MANUFACTURED IN DONGYANG CITY, ZHEJIANG PROVINCE, CHINA RILPIVIRINE HYDROCHLORIDE AS MANUFACTURED IN SHANGHAI, CHINA

Page 810

4Q2012EXCEL DMF# 26306 26307 26308 26309 26310 26311 A 26312 A 26313 A 26314 26315 26316 26317 26318 26319 26320 26321 26322 26323 26324 26325 26326 26327 26328 26329 26330 26331 26332 26333 26334 A A A A A A A A A A A P A A A A A A A A A II IV II II II II III II II II II II III II III II III III III III 8/24/2012 8/10/2012 10/9/2012 8/27/2012 9/22/2012 8/29/2012 8/16/2012 7/26/2012 8/17/2012 10/15/2012 9/6/2012 8/21/2012 8/14/2012 8/18/2012 8/8/2012 6/13/2012 8/8/2012 8/8/2012 8/8/2012 8/8/2012 AUROBINDO PHARMA LTD RT VANDERBILT CO INC LUPIN LTD MACLEODS PHARMACEUTICALS LTD MACLEODS PHARMACEUTICALS LTD UNIMARK REMEDIES LTD VERSALIS SPA GEDEON RICHTER PLC ACEBRIGHT INDA PHARMA PRIVATE LTD GLENMARK GENERICS LTD PAN DRUGS LTD *** PENDING FILING REVIEW *** AMBIOPHARM INC 3M DRUG DELIVERY SYSTEMS SICHUAN XIELI PHARMACEUTICAL CO LTD SHENG ZOU RUBBER AND PLASTICS HEMMO PHARMACEUTICALS PVT LTD SHENG ZOU RUBBER AND PLASTICS SHENG ZOU RUBBER AND PLASTICS SHENG ZOU RUBBER AND PLASTICS SHENG ZOU RUBBER AND PLASTICS II 8/30/2012 AUROBINDO PHARMA LTD II 9/21/2012 A A A A A II 9/4/2012 STATUS Type SUBMIT DATE III II II III II 8/8/2012 8/14/2012 8/3/2012 8/8/2012 8/8/2012 HOLDER COLORTECH INC SUBJECT

4Q2012

11525-16 WHITE POLYETHYLENE CONCENTRATE AS MANUFACTURED IN MORRISTOWN, TENNESSEE AND ONTARIO, CANADA HETERO DRUGS LTD ENTECAVIR MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CENTAUR PHARMACEUTICALS PRIVATE LTD TETRABENAZINE AS MANUFACTURED IN MAHARASHTRA, INDIA KOREA ALUMINUM CO LTD LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTD ZHEJIANG HISUN PHARMACEUTICAL CO LTD CR(CHILD RESISTANT) FILM/PEEL & PUSH AS MANUFACTURED IN CHUNG-BUK, KOREA VANCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN FUZHOU CITY, FUJIAN PROVINCE, P.R. CHINA TIGECYCLINE (ESUB) AS MANUFACTURED IN TAIZHOU CITY, CHINA

ZHEJIANG HISUN PHARMACEUTICAL CO LTD BLEOMYCIN SULFATE PROCESS II (ESUB) AS MANUFACTURED IN TAIZHOU CITY, CHINA LACOSAMIDE (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA VALGANCICLOVIR HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA VEEGUM; NATIONAL FORMULARY GRADES" AS MANUFACTURED IN MURRAY, KY RUFINAMIDE (ESUB) AS MANUFACTURED IN GUJRAT, INDIA PREGABALIN (ESUB) AS MANUFACTURED IN GUJARAT, INDIA OLMESARTAN MEDOXOMIL (ESUB) AS MANUFACTURED IN GUJARAT, INDIA TENOFOVIR DISOPROXIL FUMARATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA FLEXIRENE MR 50 A AS MANUFACTURED IN DUNKERQUE FRANCE FOR VERSALIS S.P.A. CARIPRAZINE HYDROCHLORIDE AS MANUFACTURED IN DOROG, HUNGARY IMATINIB MESYLATE [DRUG SUBSTANCE(NON-STERILE)] AS MANUFACTURED IN KARNATAKA, INDIA LACOSAMIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA GUAIFENESIN USP (NEW ROUTE) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA GLUCAGON, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN NORTH AUGUSTA, SC, AND SHANGHAI, CHINA 3M COTRAN 9697 TAN NONWOVEN POLYURETHANE TAPE AS MANUFACTURED IN BROOKINGS, SD DOCETAXEL AS MANUFACTURED IN PENGZHOU CITY, CHINA SHENGZOU FORMULATION A03(A03B) RUBBER STOPPER AS MANUFACTURED IN HEFEI CITY AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS OCTREOTIDE ACETATE AS MANUFACTURED IN DISTRICT THANE, INDIA SHENG ZOU RUBBER STOPPER FORMULATION A18(A18B) AS MANUFACTURED IN HEFEI CITY AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS SHENG ZOU RUBBER STOPPER FORMULATION A04(A04B) AS MANUFACTURED IN HEFEI CITY AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS SHENG ZOU FORMULATION A01 (A01B) RUBBER STOPPER AS MANUFACTURED IN HEFIEI CITY, CHINA AND SUZHOU CITY CHINA FOR SHENG ZOU RUBBER AND PLASTICS SHENG ZOU FORMULATION A41(A41B) RUBBER STOPPER AS MANUFACTURED IN HEFEI CITY, CHINA AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS

Page 811

4Q2012EXCEL DMF# 26335 STATUS Type SUBMIT DATE A III 8/8/2012 HOLDER SHENG ZOU RUBBER AND PLASTICS SUBJECT

4Q2012

SHENG ZOU FORMULATION K02 (K02B) RUBBER STOPPER AS MANUFACTURED IN HEFEI CITY, CHINA AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS SHENG ZOU FORMULATION F22 (F22B) RUBBER STOPPER AS MANUFACTURED IN HEFEI CITY, CHINA AND SUZHOU CITY, CHINA FOR SHENG ZOU RUBBER AND PLASTICS

26336

III

8/8/2012

SHENG ZOU RUBBER AND PLASTICS

26337 26338 26339 26340 26341 26342 26343 26344 26345 26346 26347 26348 26349 26350 26351 26352 26353 26354 26355 26356 26357 26358 26359 26360 26361 26362 26363 26364 26365 26366 26367 26368

P P A P A A A P A A A P A P A A A A A A A P A A A A P P P A P P

II

11/29/2012

*** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** GLAXOSMITHKLINE LLC *** PENDING FILING REVIEW *** EMCURE PHARMACEUTICALS LTD ZHEJIANG KANGLE PHARMACEUTICAL CO LTD NIVIKA CHEMO PHARMA PVT LTD *** PENDING FILING REVIEW *** APOTEX PHARMACHEM INDIA PVT LTD QILU ANTIBIOTICS PHARMACEUTICAL CO LTD NEULAND LABORATORIES LTD *** PENDING FILING REVIEW *** ALEMBIC PHARMACEUTICALS LTD API DIV *** PENDING FILING REVIEW *** MOREPEN LABORATORIES LTD SIEMENS MOLECULAR IMAGING INC HOSPIRA INC ACS DOBFAR SPA MAC CHEM PRODUCTS INDIA PVT LTD PHARMAZELL VIZAG PRIVATE LTD TEVA PHARMACEUTICAL INDUSTRIES LTD *** PENDING FILING REVIEW *** CHROMO LABORATORIES INDIA PRIVATE LTD BLOOMAGE FREDA BIOPHARM CO LTD ALKERMES GAINESVILLE LLC SICHUAN XIELI PHARMACEUTICAL CO LTD *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** MALLINCKRODT INC *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW ***

UMECLIDINIUM BROMIDE (ESUB) AS MANUFACTURED IN HERTFORDSHIRE, UK AND JURONG, SINGAPORE FOR GLAXOSMITHKLINE SULFAMETHOXAZOLE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA ACETAMINOPHEN DC90 AS MANUFACTURED IN WENZHOU CITY, CHINA NEBIVOLOL HCI AS MANUFACTURED IN GUJARAT, INDIA FESOTERODINE FUMARATE AS MANUFACTURED IN BANGALORE, INDIA STERILE CEFUROXIME SODIUM PROCESS 1, BULK ANTIBIOTIC DRUG SUBSTANCE AS MANUFACTURED IN SHANDONG CHINA DAPIPRAZOLE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA LACOSAMIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA ATORVASTATIN CALCIUM TRIHYDRATE AS MANUFACTURED IN HIMACHAL PRADESH, INDIA SODIUM ACETATE C11 INJECTION AS MANUFACTURED IN OVERLAND PARK, KS NT100H DRUG SUBSTANCE (ESUB) AS MANUFACTURED IN THEBARTON, AUSTRALIA FOR HOSPIRA, INC CEFPROZIL AS MANUFACTURED IN MILANO, ITALY BICALUTAMIDE USP AS MANUFACTURED IN BOISAR, INDIA CELECOXIB USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA DESVENLAFAXINE BASE AS MANUFACTURED IN BHIND, INDIA AND BEER SHEVA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD. ZAFIRLUKAST PREMIX-50% W/W (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA SODIUM HYALURONATE (HA-E 3.0) AS MANUFACTURED IN JINAN CITY, P.R. OF CHINA N1752 EXTENDED RELEASE TABLETS, 18MG AS MANUFACTURED IN ATHLONE, IRELAND FOR ALKERMES GAINESVILLE LLC IMATINIB MESYLATE AS MANUFACTURED IN PENGZHOU CITY, CHINA

II II II II II II II II II II II II II II

8/31/2012 8/16/2012 8/21/2012 8/17/2012 8/8/2012 8/23/2012 9/7/2012 8/23/2012 8/24/2012 9/28/2012 8/22/2012 8/27/2012 8/20/2012 8/26/2012

II II II

8/20/2012 8/28/2012 8/23/2012

II

11/27/2012

NORBUPRENORPHINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ST. LOUIS, MO

Page 812

4Q2012EXCEL DMF# 26369 26370 26371 26372 26373 26374 26375 26376 26377 26378 26379 26380 26381 26382 26383 26384 26385 26386 26387 26388 26389 26390 26391 26392 26393 26394 26395 26396 STATUS Type SUBMIT DATE A A A A A A A A A P A A A A A A A A A A A A A A P A A A II II IV III V II II II II 9/10/2012 9/7/2012 8/31/2012 8/7/2012 8/3/2012 8/29/2012 9/5/2012 9/5/2012 9/4/2012 HOLDER AUROBINDO PHARMA LTD MSN PHARMACHEM PVT LTD WILD FLAVORS INC SAMSUNG P AND S CO LTD MICROTROL STERILISATION SERVICES PVT LTD SYN TECH CHEM AND PHARM CO LTD ASENCE PHARMA PRIVATE LTD MEDICHEM MANUFACTURING MALTA LTD JIANGSU HENGRUI MEDICINE CO LTD *** PENDING FILING REVIEW *** TEVA PHARMACEUTICAL INDUSTRIES LTD AMBIOPHARM INC TEVA PHARMACEUTICAL INDUSTRIES LTD EUTICALS INC MYLAN LABORATORIES LTD NIPPON SODA CO LTD MSN LABORATORIES LTD MSN LABORATORIES LTD UNIT II AUROBINDO PHARMA LTD SICHUAN XIELI PHARMACEUTICAL CO LTD FARMABIOS S P A TERUMO CORP C S BIO CO RAKS PHARMA PVT LTD *** PENDING FILING REVIEW *** UNGERER AND CO ANDWIN SCIENTIFIC CHROMO LABORATORIES INDIA PRIVATE LTD SUBJECT

4Q2012

CEFIXIME USP (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FESOTERODINE FUMARATE [ROUTE CODE FF] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA NATURAL PEPPERMINT FLAVOR WONF #FALT526 AS MANUFACTURED IN ERLANGER, KY CONTAINER & CLOSURE AS MANUFACTURED IN GYEONGGI-DO, SOUTH KOREA ETHYLENE OXIDE STERILISATION CROTAMITON AS MANUFACTURED IN TAINAN CITY, TAIWAN AMPHOTERICIN B USP [PARENTERAL GRADE] AS MANUFACTURED IN VADODARA, GUJARAT, INDIA FOR ASENCE PHARMA PRIVATE LIMITED MED-200850/M (LACOSAMIDE) AS MANUFACTURED IN HAL FAR BBG, MALTA DEXMEDETOMIDINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN LIANYUNGANG, JIANGSU, CHINA DESVENLAFAXINE FUMARATE (ESUB) AS MANUFACTURED IN BEER SHEVA, ISRAEL AND BHIND (MADHYA PRADESH), INDIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD LEUPROLIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN NORTH AUGUST, SC, SHANGHAI, CHINA, AND HAIKOU CITY, CHINA FOR AMBIOPHARM, INC LACOSAMIDE (ESUB) AS MANUFACTURED IN PRIGORJE BRDOVECKO, CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD LACOSAMIDE AS MANUFACTURED IN SPRINGFIELD, MO THIOTEPA USP AS MANUFACTURED IN MAHARASHTRA, INDIA HYDROXYPROPYL CELLULOSE OR HPC AS MANUFACTURED IN NIIGATA, JAPAN FOR NIPPON SODA CO., LTD RUFINAMIDE [ROUTE CODE RU] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA IMATINIB MESYLATE [ROUTE CODE-" IT"] (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA PREGABALIN (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN PENGZHOU CITY, CHINA STERILIZED MEDROXYPROGESTERONE ACETATE USP ( MICRONIZED) AS MANUFACTURED IN GROPELLO CAIROLI (PV), ITALY PLAJEX-READY-TO-FILL PLASTIC SYRINGES AS MANUFACTURED IN SHIZUOKA, JAPAN TRIPTORELIN ACETATE, NON- STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN MENLO PARK, CA FESOTERODINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA NATURAL CHERRY WONF FLAVOR FV-7380 AS MANUFACTURED IN BETHLEHEM, PENNSYLVANIA SEALSAFE SELF-SEALING DOSING ADAPTERS AS MANUFATCURED IN WOODLAND HILLS, CALIFORNIA REPAGLINIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

II II II II II IV II II II II II III II II IV III II

9/24/2012 9/5/2012 9/27/2012 9/5/2012 9/5/2012 9/5/2012 9/29/2012 11/6/2012 9/14/2012 9/12/2012 9/4/2012 9/7/2012 9/5/2012 8/30/2012 8/29/2012 9/4/2012 9/10/2012

Page 813

4Q2012EXCEL DMF# 26397 26398 26399 26400 26401 26402 26403 26404 26405 26406 26407 26408 26409 26410 26411 26412 26413 26414 26415 26416 26417 26418 26419 26420 26421 26422 26423 26424 26425 26426 26427 26428 26429 26430 STATUS Type SUBMIT DATE A A A P A A A A A A A P A A A A A A A A A A A A A A A A A A A A A A II II II II II II II II II IV III III II V III II III II II II II II III II II II II II II IV II II 9/6/2012 9/7/2012 9/6/2012 11/5/2012 9/18/2012 9/3/2012 9/19/2012 11/23/2012 12/16/2012 8/29/2012 8/22/2012 9/7/2012 8/20/2012 9/7/2012 8/21/2012 9/14/2012 9/14/2012 9/14/2012 10/1/2012 9/11/2012 9/27/2012 9/6/2012 7/13/2012 9/11/2012 9/14/2012 9/11/2012 9/11/2012 9/11/2012 9/17/2012 9/18/2012 9/17/2012 9/18/2012 HOLDER HETERO LABS LTD SUL OXIDOS INDUSTRIA E COMERCIO LTDA MYLAN LABORATORIES LTD *** PENDING FILING REVIEW *** DR REDDYS LABORATORIES LTD ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD SICHUAN XIELI PHARMACEUTICAL CO LTD HISUN PHARMACEUTICAL HANGZHOU CO LTD HISUN PHARMACEUTICAL HANGZHOU CO LTD ZHEJIANG HISUN PHARMACEUTICAL CO LTD UNGERER AND CO *** PENDING FILING REVIEW *** TIANJIN BOKELIN MEDICAL PACKAGING TECHNOLOGY CO LTD NYPRO INC MANHATTAN ISOTOPE TECHNOLOGY LLC DAIKYO SEIKO LTD VERSALIS SPA NEULAND LABORATORIES LTD SUMITOMO RUBBER INDUSTRIES LTD FERMION OY ALEMBIC PHARMACEUTICALS LTD DIVIS LABORATORIES LTD UNIMARK REMEDIES LTD QILU TIANHE PHARMACEUTICAL CO LTD SHIJIAZHUANG ZHONGHUI LEECHDOM PACKING CO LTD ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD HETERO DRUGS LTD ACEBRIGHT INDA PHARMA PRIVATE LTD ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD UNIV MISSOURI RESEARCH REACTOR CENTER HETERO DRUGS LTD FONA INTERNATIONAL INC SUBJECT

4Q2012

VALSARTAN (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ZINC OXIDE AS MANUFACTURED IN SANTA CATARINA, BRAZIL MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FINGOLIMOD HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA NAPROXEN SODIUM GRANULE (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA CAPECITABINE AS MANUFACTURED IN SICHUAN, CHINA MYCOPHENOLIC ACID (ESUB) AS MANUFACTURED IN FUYANG CITY AND HANGZHOU CITY, CHINA MYCOPHENOLATE MOFETIL (ESUB) AS MANUFACTURED IN FUYANG CITY, HANGZHOU CITY AND ZHEJIANG, CHINA PITAVASTATIN CALCIUM (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA ARTIFICIAL CARAMEL FLAVOR FV-7382 AS MANUFACTURED IN BETHLEHEM, PA CODE NAME: G60T-004 AS MANUFACTURED IN TIANJIN, P.R. CHINA TABLET APPLICATOR AS MANUFACTURED IN HOSUR, INDIA FOR NYPRO INC STRONTIUM-82 DRUG SUBSTANCE AS MANUFACTURED IN LUBBOCK, TEXAS RSV COMPONENT WASHING PROCESS AT HANDEA II BUILDING B IN OCHIGI, JAPAN FLEXIRENE MT 40 A AS MANUFACTURED IN DUNKERQUE, FRANCE FOR VERSALIS SPA ROPINIROLE AS MANUFACTURED IN ANDHRA PRADESH, INDIA RUBBER CLOSURE AS MANUFACTURED IN HYOGO, JAPAN CARBIDOPA AS MANUFACTURED IN HANKO, FINLAND FEBUXOSTAT (ESUB) AS MANUFACTURED IN GUJARAT, INDIA IRBESARTAN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA DARIFENACIN HYDROBROMIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA OLMESARTAN MEDOXOMIL (NON-STERILA API) AS MANUFACTURED IN JINAN, CHINA HDPE BOTTLES FOR ORAL SOLID PREPARATION AS MANUFACTURED IN SHIJIAZHUANG CITY, P.R. CHINA VALGANCICLOVIR HYDROCHLORIDE, CRYSTALLINE (DRUG SUBSTANCE) AS MANUFACTURED IN XIANJU, P.R. CHINA SILODOSIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA IMATINIB MESYLATE A-FORM [DRUG SUBSTANCE(NON-STERILE)] AS MANUFACTURED IN KARNATAKA, INDIA SITAGLIPTIN PHOSPHATE ANHYDROUS AS MANUFACTURED IN DONGYANG CITY, CHINA POTASSIUM MOLYBDATE (MO-99) FINAL INTERMEDIATE RADIOCHEMICAL AS MANUFACTURED IN COLUMBIA, MISSOURI FESOTERODINE FUMARATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA PRODUCT # 807.0439U MIXED BERRY FLAVOR, ART AS MANUFACTURED IN GENEVA, IL

ST GOBAIN PERFORMANCE PLASTICS CORP BIO-SIL(R) 1450 AS MANUFACTURED IN TAUNTON, MA INDO PHYTO CHEMICALS PRIVATE LTD TESTOSTERONE USP AS MANUFACTURED IN UTTARAKHAND, INDIA

Page 814

4Q2012EXCEL DMF# 26431 26432 26433 26434 26435 26436 26437 26438 26439 26440 26441 26442 26443 26444 26445 26446 26447 26448 26449 26450 26451 26452 26453 26454 26455 26456 26457 26458 26459 26460 STATUS Type SUBMIT DATE A A A A A A A A A A A P P A P A A A A A A A A A A A A A A A II II II II II II II II II II II II II II II 9/26/2012 9/26/2012 9/17/2012 9/7/2012 9/7/2012 8/9/2012 9/27/2012 9/20/2012 8/30/2012 9/21/2012 9/18/2012 9/12/2012 9/18/2012 9/21/2012 9/18/2012 II 11/1/2012 II III IV II III III II II II II II 9/11/2012 9/17/2012 9/12/2012 9/17/2012 9/17/2012 9/17/2012 9/12/2012 9/18/2012 11/6/2012 10/31/2012 10/25/2012 HOLDER LAURUS LABS PRIVATE LTD ROSELABS BIOSCIENCE LTD ANKIT PULPS & BOARDS PVT LTD (PHARMA DIVISION) ZHEJIANG XIANJU XIANMING PHARMACEUTICAL CO LTD ROSELABS BIOSCIENCE LTD ROSELABS BIOSCIENCE LTD SICHUAN XIELI PHARMACEUTICAL CO LTD CATALENT PHARMA SOLUTIONS LLC UNIMARK REMEDIES LTD GLAND CHEMICALS PRIVATE LTD GLAND CHEMICALS PRIVATE LTD *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** DR REDDYS LABORATORIES LTD *** PENDING FILING REVIEW *** BIOPHORE INDIA PHARMACEUTICALS PVT. LTD BIOPHORE INDIA PHARMACEUTICALS PVT LTD MACFARLAN SMITH LTD A JOHNSON MATTHEY CO XIWANG PHARMACEUTICAL CO LTD XIWANG PHARMACEUTICAL CO LTD HUNAN LIJIE BIOCHEMICAL CO LTD AUROBINDO PHARMA LTD HYBIO PHARMACEUTICAL CO LTD BEIJING GEYUAN TIANRUN BIO TECH CO LTD ARGUS PHARMACEUTICALS LTD SICHUAN XIELI PHARMACEUTICAL CO LTD WUXI KAILI PHARMACEUTICAL CO LTD TIANJIN TIANYAO PHARMACEUTICALS CO LTD SANDOZ PRIVATE LTD SICHUAN XIELI PHARMACEUTICAL CO LTD PLERIXAFOR (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA SUBJECT PEMETREXED DISODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA

4Q2012

ROSE-FILL-LT-2.25 ML (STERILE DISPOSABLE PRE-FILLABLE GLASS SYRINGES 2.25 ML) AS MANUFACTURED IN GUJARAT, INDIA MICROCRYSTALLINE CELLULOSE (USP) OF VARIOUS GRADES AS MANUFACTURED IN MAHARASHTRA, INDIA PROGESTERONE, USP AS MANUFACTURED IN ZHEJIANG, CHINA ROSE-FILL-LT-5.0 ML (STERILE DISPOSABLE PRE-FILLABLE GLASS SYRINGES 5.0 ML) AS MANUFACTURED IN GUJARAT, INDIA ROSE-FILL-LT-1.0 ML (STERILE DISPOSABLE PRE-FILLABLE GLASS SYRINGES 1.0 ML) AS MANUFACTURED IN GUJARAT, INDIA TRIMETAZIDINE DIHYDROCHLORIDE AS MANUFACTURED IN PENGZHOU CITY, CHINA PALONOSETRON HC1 0.50 MG SOFTGELS (1.5 OVAL) AS MANUFACTURED IN SOMERSET, NEW JERSEY MONTELUKAST SODIUM USP (PROCESS-C) (ESUB) AS MANUFACTURED IN GUJARAT, INDIA BORTEZOMIB (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA ROCURONIUM BROMIDE USP (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA

ZILEUTON (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE INDIA PHARMACEUTICALS PVT. LTD. PHYTONADIONE (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR BIOPHORE INDIA PHARMACEUTICALS PVT. LTD. BUPRENORPHINE AS MANUFACTURED IN SCOTLAND, UNITED KINGDOM DEXTROSE MONOHYDRATE AS MANUFACTURED IN BINZHOU CITY, P.R. CHINA DEXTROSE ANHYDROUS AS MANUFACTURED IN BINZHOU CITY, P.R. CHINA CHLOROXYLENOL AS MANUFACTURED IN CHANGSHA, CHINA GATIFLOXACIN HEMIHYDRATE (NON-STERILE DRUG SUBSTANCE) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA EPTIFIBATIDE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN GUANGDONG, P.R. CHINA CHYMOTRYPSIN (NON-STERILE, BULK FORM) AS MANUFACTURED IN BEIJING, CHINA ORLISTAT AS MANUFACTURED IN CHANGSHA, CHINA GEFITINIB AS MANUFACTURED IN PENGZHOU CITY, CHINA EPTIFIBATIDE AS MANUFACTURED IN YIXING CITY, P.R. CHINA METHYLPREDNISOLONE, USP BULK AS MANUFACTURED IN TIANJIN, CHINA SILODOSIN AS MANUFACTURED IN MAHARASHTRA, INDIA SORAFENIB TOSYLATE AS MANUFACTURED IN PENGZHOU, CHINA

Page 815

4Q2012EXCEL DMF# 26461 26462 26463 26464 26465 26466 26467 26468 26469 26470 26471 26472 26473 26474 26475 26476 26477 26478 26479 26480 A 26481 26482 26483 26484 26485 26486 26487 26488 26489 26490 26491 26492 26493 A A A A P P A A A A A A A II II II II II II II 9/24/2012 9/21/2012 9/27/2012 9/27/2012 9/27/2012 9/27/2012 9/28/2012 II II II II 9/26/2012 9/24/2012 10/12/2012 9/27/2012 INTERQUIM SA SICHUAN XIELI PHARMACEUTICAL CO LTD AMOLI ORGANICS PVT LTD SIGNA SA DE CV *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** SICHUAN XIELI PHARMACEUTICAL CO LTD SICHUAN XIELI PHARMACEUTICAL CO LTD AMBIOPHARM INC EUTICALS INC LEK PHARMACEUTICALS DD SICHUAN XIELI PHARMACEUTICAL CO LTD SICHUAN XIELI PHARMACEUTICAL CO LTD TROXERUTIN AS MANUFACTURED IN SICHUAN, CHINA SOY ISOFLAVONES AS MANUFACTURED IN SICHUAN, CHINA STATUS Type SUBMIT DATE A A A A A A A A A A A A A A A A P P P II 10/12/2012 II II II II II II II II II II III II II II II II 9/20/2012 9/18/2012 10/6/2012 9/18/2012 9/20/2012 9/21/2012 9/21/2012 9/20/2012 11/16/2012 9/17/2012 9/21/2012 10/6/2012 9/21/2012 9/11/2012 10/3/2012 9/21/2012 HOLDER SICHUAN XIELI PHARMACEUTICAL CO LTD SICHUAN XIELI PHARMACEUTICAL CO LTD EMCURE PHARMACEUTICALS LTD SICHUAN XIELI PHARMACEUTICAL CO LTD SICHUAN XIELI PHARMACEUTICAL CO LTD TOMITA PHARMACEUTICAL CO LTD GLOCHEM INDUSTRIES LTD ERREGIERRE SPA NECTAR LIFESCIENCES LTD RESONANCE LABORATORIES PVT LTD EQUISTAR CHEMICALS LP A LYONDELLBASELL INDUSTRIES CO CADILA HEALTHCARE LTD INCELL CORP LLC SUBJECT VIDAGLIPTIN AS MANUFACTURED IN PENGZHOU, CHINA CABAZITAXEL AS MANUFACTURED IN PENGZHOU, CHINA

4Q2012

RITONAVIR USP (PROCESS II) (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA SUNITINIB MALATE AS MANUFACTURED IN PENGZHOU, CHINA LAPATINIB TOSYLATE AS MANUFACTURED IN PENGZHOU, CHINA USP SODIUM SULFATE, ANHYDROUS AS MANUFACTURED IN TOKUSHIMA, JAPAN CETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED AT VISAKHPATNAM DISTRICT FACILITY IN ANDHRA PRADESH, INDIA DEFERASIROX AS MANUFACTURED IN BERGAMO, ITALY CEFTAZIDIME FOR INJECTION USP (STERILE BULK) (ESUB) AS MANUFACTURED IN TEHSIL DERA BASSI, INDIA GLYCOPYRROLATE AS MANUFACTURED IN BANGALORE, INDIA PRO-FAX SR257M POLYPROPYLENE COPOLYMER RESIN AS MANUFACTURED IN BAYPORT, TEXAS AND LAKE CHARLES, LOUISIANA LACOSAMIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA ZAPR RED BLOOD CELL LYSING BUFFER AS MANUFACTURED IN SAN ANTONIO, TEXAS

JIAXING HENGJIE BIOPHARMACEUTICAL CO CHONDROITIN SULFATE SODIUM (NON STERILE, BULK FORM) AS MANUFACTURED IN LTD JIAXING, P.R. CHINA DR REDDYS LABORATORIES LTD DUTASTERIDE (PROCESS-II) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ZHEJIANG MEDICINE CO LTD XINCHANG PHARMACEUTICAL FACTORY *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** MSN ORGANICS PVT LTD "(2R,3R)-3(3-METHOXY PHENYL)-N,N,2-TRIMETHYL PENTANE-1-AMINE HYDROCHLORIDE [ROUTE CODE TPT4]" (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ROTIGOTINE AS MANUFACTURED IN BARCELONA, SPAIN DIOSMIN AS MANUFACTURED IN PENGZHOU, CHINA CLOTRIMAZOLE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA LACOSAMIDE AS MANUFACTURED IN TOLUCA MX, MEXICO BOSENTAN MONOHYDRATE AS MANUFACTURED IN XINCHANG, P.R. CHINA

GLATIRAMER NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN NORTH AUGUSTA, SC AND SHANGHAI, CHINA TAPENTADOL HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN SPRINGFIELD, MISSOURI FESOTERODINE FUMARATE AS MANUFACTURED IN LJUBLJANA, SLOVENIA RALOXIFENE HYDROCHLORIDE AS MANUFACTURED IN PENGZHOU, CHINA TELBIVUDINE AS MANUFACTURED IN PENGZHOU, CHINA

Page 816

4Q2012EXCEL DMF# 26494 26495 26496 26497 26498 26499 26500 26501 26502 26503 26504 26505 26506 26507 26508 26509 26510 26511 26512 26513 26514 26515 26516 26517 26518 26519 26520 26521 26522 26523 26524 26525 STATUS Type SUBMIT DATE A A A A A A A A A A A A A A A A A A A A A A A A P A A A A A A A II II II II II II II 10/23/2012 10/19/2012 10/3/2012 10/3/2012 10/3/2012 10/3/2012 10/4/2012 II II III II II II II II II II II II IV II II II III III III II II II III II 9/25/2012 9/26/2012 9/25/2012 9/28/2012 9/28/2012 9/26/2012 9/27/2012 9/27/2012 9/26/2012 10/13/2012 9/26/2012 10/30/2012 10/1/2012 10/24/2012 9/28/2012 9/28/2012 9/28/2012 9/28/2012 9/28/2012 9/28/2012 10/25/2012 10/1/2012 10/1/2012 9/22/2012 HOLDER SICHUAN XIELI PHARMACEUTICAL CO LTD SICHUAN XIELI PHARMACEUTICAL CO LTD COIM USA INC SICHUAN XIELI PHARMACEUTICAL CO LTD CHEMI SPA MYLAN LABORATORIES LTD SHASUN PHARMACEUTICALS LTD HETERO LABS LTD SYN TECH CHEM AND PHARM CO LTD INTAS PHARMACEUTICALS LTD SYN TECH CHEM AND PHARM CO LTD DSM SINOCHEM PHARMACEUTICALS NETHERLANDS BV SHANXI GUANGSHENG MEDICINAL CAPSULE CO LTD WOCKHARDT LTD SICHUAN XIELI PHARMACEUTICAL CO LTD SICHUAN XIELI PHARMACEUTICAL CO LTD ROSELABS POLYMERS LTD. ROSELABS POLYMERS LTD. ROSELABS POLYMERS LTD. MERCK AND CIE SUBJECT DASATINIB AS MNAUFACTURED IN PENGZHOU, CHINA SITAGLIPTIN PHOSPHATE AS MANUFACTURED IN PENGZHOU, CHINA

4Q2012

NOVACOTE HS-8256 AS MANUFACTURED IN OFFANENGO, ITALY FOR COIM USA, INC NILOTINIB AS MANUFACTURED IN PENGZHOU, CHINA FESOTERODINE FUMARATE AS MANUFACTURED IN FROSINONE, ITALY AND BAHIA, BRAZIL FOR CHEMI SPA RIVASTIGMINE (PROCESS II) AS MANUFACTURED IN MAHARASHTRA, INDIA LEVETIRACETAM AS MANUFACTURED IN CUDDALORE, INDIA ENTACAPONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA NAFTOPIDIL AS MANUFACTURED IN TAINAN, TAIWAN FESOTERODINE FUMARATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA GRANISETRON HYDROCHLORIDE AS MANUFACTURED IN TAINAN, TAIWAN AMPICILLIN TRIHYDRATE (PURICILLIN) (ESUB) AS MANUFACTURED IN PUNJAB, INDIA FOR DSM SINOCHEM PHARMACEUTICALS NETHERLANDS B.V. VACANT CAPSULE AS MANUFACTURED IN SHANXI, CHINA FESOTERODINE FUMARATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA HESPERIDIN AS MANUFACTURED IN PENGZHOU, CHINA RUTOSIDE TRIHYDRATE AS MANUFACTURED IN PENGZHOU, CHINA ROSEPOLY FILL LT 5 ML (STERILE HYPODERMIC DISPOSABLE PREFILLABLE SYRINGE 5 ML) AS MANUFACTURED IN GUJART, INDIA ROSEPOLY FILL LT 2.25 ML (STERILE HYPODERMIC DISPOSABLE PREFILLABLE SYRINGE 2.25 ML) AS MANUFACTURED IN GUJARAT, INDIA ROSEPOLY FILL LT 1 ML (STERILE HYPODERMIC DISPOSABLE PREFILLABLE SYRINGE 1 ML) AS MANUFACTURED IN GUJART, INDIA (R)-DOTAP CHLORIDE AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND

ZHEJIANG EXCEL PHARMACEUTICAL CO LTD GABAPENTIN [API] (ESUB) AS MANUFACTURED IN ZHEJIANG, CHINA HETERO LABS LTD PROLAMINA CORP HEMMO PHARMACEUTICALS PVT LTD *** PENDING FILING REVIEW *** ALKEM LABORATORIES LTD INTAS PHARMACEUTICALS LTD IRVINE SCIENTIFIC SALES CO IRVINE SCIENTIFIC SALES CO IRVINE SCIENTIFIC SALES CO IRVINE SCIENTIFIC SALES CO HETERO DRUGS LTD TAPENTADOL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA LACOSAMIDE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA BALANCD CHO FEED 3 AS MANUFACTURED IN SANTA ANA, CALIFORNIA BALANCD CHO FEED 2 (PRODUCT NUMBER 94121) AS MANUFACTURED IN SANTA ANA, CALIFORNIA BALANCD CHO FEED 1 (PRODUCT NUMBER 94119) AS MANUFCATURED IN SANTA ANA, CALIFORNIA BALANCD CHO GROWTH A (PRODUCT NUMBER 94120) AS MANUFACTURED IN SANTA ANA, CALIFORNIA MOXIFLOXACIN HYDROCHLORIDE ANHYDROUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA FLEXIBLE PACKAGING FOR PHARMACEUTICALS APPLICATIONS AS MANUFACTURED IN WESTFIELD, MA, NEENAH, WI, AND TERREBONNE QC CANADA OXYTOCIN AS MANUFACTURED IN TURBHE, INDIA

Page 817

4Q2012EXCEL DMF# 26526 26527 26528 26529 26530 A 26531 26532 26533 A 26534 26535 26536 26537 26538 26539 A 26540 26541 26542 A 26543 A 26544 A 26545 A 26546 26547 26548 26549 A 26550 26551 26552 26553 26554 A 26555 26556 A 26557 A II 10/10/2012 AMPACET CORP P IV 10/16/2012 *** PENDING FILING REVIEW *** NEOPHARM CO LTD A A P A IV II 10/16/2012 9/14/2012 II II 9/14/2012 9/18/2012 A A A II II II II 9/25/2012 12/6/2012 10/5/2012 9/25/2012 PIRAMAL HEALTHCARE LTD NATCO ORGANICS LTD GULBRANDSEN TECHNOLOGIES INC WATERSTONE PHARMACEUTICALS HUBEI CO LTD MAC CHEM PRODUCTS INDIA PVT LTD MELODY HEALTHCARE PVT LTD *** PENDING FILING REVIEW *** UNGERER AND CO MAC CHEM PRODUCTS INDIA PVT LTD N/A CHERRY FLAVOR FV-7379 AS MANUFACTURED IN BETHLEHEM, PA II 11/14/2012 SAI LIFE SCIENCES LTD II 10/30/2012 II 10/11/2012 A A II II III 10/11/2012 10/3/2012 10/12/2012 A A A A A II III II II II II 10/10/2012 9/24/2012 10/17/2012 10/22/2012 10/8/2012 10/8/2012 ITF CHEMICAL LTDA AMERICHEM INC AMOLI ORGANICS PVT LTD WATSON PHARMA PRIVATE LTD DAEWOONG BIO INC ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD BIOCON LTD PORTON FINE CHEMICALS LTD POLINAS PLASTIK SANAYII VE TICARETI AS P A II II 9/27/2012 9/30/2012 STATUS Type SUBMIT DATE A A A A III IV II II II 10/2/2012 10/4/2012 9/14/2012 10/8/2012 9/28/2012 HOLDER NAN YA PLASTICS CORP FONA INTERNATIONAL INC CILAG AG ST PHARM CO LTD KURASHIKI TEXTILE MANUFACTURING CO LTD *** PENDING FILING REVIEW *** AVANTI POLAR LIPIDS INC MEGAFINE PHARMA P LTD SUBJECT

4Q2012

POLYVINYL CHLORIDE (PVC) PELLETS, MEDICAL GRADE AS MANUFACTURED IN KAOHSIUNG CITY, TAIWAN (R.O.C.) PRODUCT # 936.1368U ARTIFICIAL FLAVOR AS MANUFACTURED IN GENEVA, ILLINOIS METHYLNALTREXONE BROMIDE AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND AND MONTEGGIO, SWITZERLAND FOR CILAG AG STAVUDINE DRUG SUBSTANCE AS MANUFACTURED IN GYEONGGI-DO, KOREA KURANBON AS MANUFACTURED IN OKAYAMA, JAPAN

DODECYLPHOSPHOCHOLINE (DPC) AS MANUFACTURED IN ALABASTER, ALABAMA DARIFENACIN HYDROBROMIDE (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN NASHIK, INDIA TEMOZOLOMIDE, USP AS MANUFACTURED IN BAHIA, BRAZIL 58616-CD1 WHITE COLORANT AS MANUFACTURED IN CUYAHOGA FALLS, OHIO TELMISARTAN USP (ESUB) MANUFACTURED IN GUJARAT, INDIA OXYBUTYNIN CHLORIDE USP (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA STERILE MEROPENEM FOR INFECTION AS MANUFACTURED IN KYUNGGI-DO, KOREA VALACYCLOVIR HYDROCHLORIDE, ANHYDROUS FORM II AS MANUFACTURED IN XIANJU, CHINA ROSUVASTATIN CALCIUM AS MANUFACTURED IN BANGALORE, INDIA NICOTINE USP AS MANUFACTURED IN CHONGQING, CHINA

BIAXIALLY ORIENTED POLYPROPYLENE FILM NAMED AS 525 AS MANUFACTURED IN MANISA, TURKEY GLOCHEM INDUSTRIES LTD PHTHALIMIDO AMLODIPINE (INTERMEDIATE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA JIANGXI TIANXIN PHARMACEUTICAL CO LTD PYRIDOXINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN JIANGXI, CHINA PARICALCITOL USP, NON-STERILE BULK DRUG (ESUB) AS MANUFACTURED IN KARNATAKA, INDIA VALACYCLOVIR HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA BORTEZOMIB (ESUB) AS MANUFACTURED IN TAMILNADU, INDIA ACHIEVE DA 1097 CP AS MANUFACTURED IN GUJARAT, INDIA FEBUXOSTAT AS MANUFACTURED IN HUBEI, CHINA LETROZOLE USP AS MANUFACTURED IN DISTRICT THANE, INDIA TIGECYCLINE AS MANUFACTURED IN MAHARASHTRA, INDIA

IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP AS MANUFACTURED IN DISTRICT THANE, INDIA METHYL CAPROOYL TYROSINATE (CODE NAME: DEFENSAMIDE) AS MANUFACTURED IN DAEJEON, KOREA 140891 ORANGE PP MB AS MANUFACTURED IN TERRE HAUTE, INDIANA

Page 818

4Q2012EXCEL DMF# 26558 A 26559 A 26560 A 26561 A 26562 26563 26564 A 26565 A 26566 26567 A 26568 A 26569 A 26570 26571 A 26572 A 26573 26574 A 26575 A 26576 26577 A 26578 26579 26580 26581 26582 26583 A 26584 26585 A A IV II 10/26/2012 10/29/2012 FONA INTERNATIONAL INC IRVINE SCIENTIFIC SALES CO P A A A P IV 10/26/2012 II II II 10/24/2012 10/26/2012 10/26/2012 *** PENDING FILING REVIEW *** MELODY HEALTHCARE PVT LTD MAC CHEM PRODUCTS INDIA PVT LTD MAC CHEM PRODUCTS INDIA PVT LTD *** PENDING FILING REVIEW *** FONA INTERNATIONAL INC LEVOSALBUTAMOL SULPHATE AS MANUFACTURED IN MAHARASHTRA, INDIA A II II 10/22/2012 12/3/2012 FUKUZYU PHARMACEUTICAL CO LTD II 10/25/2012 IRVINE SCIENTIFIC SALES CO P II 10/25/2012 *** PENDING FILING REVIEW *** IRVINE SCIENTIFIC SALES CO II 10/25/2012 IRVINE SCIENTIFIC SALES CO A II II 10/16/2012 11/29/2012 III 10/10/2012 HPT HOCHWERTIGE PHARMATECHNIK GMBH CO KG KINOMEGA BIOPHARM INC. TEVA PHARMACEUTICAL INDUSTRIES LTD III 10/10/2012 AMPACET CORP A III III 10/9/2012 10/10/2012 AMPACET CORP AMPACET CORP III 10/10/2012 AMPACET CORP A A II II III 10/24/2012 9/14/2012 10/10/2012 II 9/28/2012 LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTD MELODY HEALTHCARE PVT LTD MELODY HEALTHCARE PVT LTD AMPACET CORP III 10/12/2012 BASF SE II 10/15/2012 HUATAI BIOPHARM INC STATUS Type SUBMIT DATE III 9/20/2012 HOLDER INVISTA RESINS AND FIBERS GMBH SUBJECT

4Q2012

POLYETHYLENE TEREPHTHALATE RESINS USED IN PACKAGING AS MANUFACTURED IN GERSTHOFEN, GERMANY OMEGA-3-ACID ETHYL ESTERS (NON-STERILE, BULK FORM) AS MANUFACTURED IN SICHUAN, P.R. CHINA ULTRAFORM W2320 003 PRO TR UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN, GERMANY PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN LIANYUNGANG, CHINA ALBUTEROL SULFATE AS MANUFACTURED IN MAHARASHTRA, INDIA TERBUTALINE SULPHATE AS MANUFACTURED IN MAHARASHTRA, INDIA 181356 DARK BROWN PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA AND HEATH, OH 454458 PEARL RED PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA AND HEATH, OH 164364-K BLUE 364 AS MANUFACTURED IN RAYONG, THAILAND 131617 YELLOW PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA AND HEATH, OH 401198 HIGH HEAT PA PP MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE, GA AND HEATH, OH WHITE PE-BOTTLE 60ML AS MANUFACTURED IN NEUHAUS A. RWG., GERMANY OMEGA-3-ACID ETHYL ESTERS AS MANUFACTURED IN DEYANG CITY, CHINA ATORVASTATIN CALCIUM ( ESUB) AS MANUFACTURED IN UTTAR PRADESH, INDIA AND MADHYA PRADESH, INDIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD BALANCD CHO GROWTH A ( PRODUCT NUMBER 91128) AS MANUFACTURED IN SANTA ANA, CALIFORNIA BALANCD CHO FEED 2 (PRODUCT NUMBER 91129) AS MANUFACTURED IN SANTA ANA CALIFORNIA BALANCD CHO FEED 1 (PRODUCT NUMBER 91127) AS MANUFACTURED IN SANTA ANA, CALIFORNIA NPS-005 AS MANUFACTURED IN TOYAMA, JAPAN

CENTAUR PHARMACEUTICALS PRIVATE LTD MILNACIPRAN HYDROCHLORIDE (ESUB) AS MUNUFACTURED IN MAHARASHTRA, INDIA

DOCETAXEL TRIHYDRATE USP AS MANUFACTURED IN DISTRICT THANE, INDIA ANASTROZOLE USP AS MANUFACTURED IN DISTRICT THANE, INDIA 863.002 N-C LEMON-LIME FLAVOR, NAT WONF AS MANUFACTURED IN GENEVA ILLINOIS 884.628 N-C ORANGE FLAVOR, NATURAL AS MANUFACTURED IN GENEVA, ILLINOIS BALANCD CHO FEED 3 (PRODUCT NUMBER 99471) AS MANUFACTURED IN SANTA ANA, CALIFORNIA

Page 819

4Q2012EXCEL DMF# 26586 A 26587 26588 26589 26590 A 26591 A 26592 A 26593 26594 26595 A 26596 26597 A 26598 A 26599 26600 26601 A 26602 26603 26604 A 26605 A 26606 A 26607 26608 A 26609 26610 A 26611 26612 26613 A 26614 A II 12/13/2012 SUN PHARMACEUTICAL INDUSTRIES LTD A A II IV III 11/7/2012 11/8/2012 11/9/2012 P II 11/2/2012 *** PENDING FILING REVIEW *** NANYANG PUKANG PHARMACEUTICAL CO LTD DERIVADOS QUIMICOS SAU FINAR LTD SANNER GMBH LINCOMYCIN HYDROCHLORIDE AS MANUFACTURED IN NANYANG, CHINA P III 11/12/2012 *** PENDING FILING REVIEW *** AMERICAN PACKAGING CORP II 12/30/2012 II 12/27/2012 A A V II II 10/22/2012 11/12/2012 12/21/2012 EVONIK INDUSTRIES AG HETERO LABS LTD A P II 11/7/2012 II 12/21/2012 GLENMARK GENERICS LTD *** PENDING FILING REVIEW *** SIGMUND LINDNER GMBH III 10/26/2012 A II II 11/5/2012 11/2/2012 AMOLI ORGANICS PVT LTD ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD NEW AGE INDUSTRIES INC A P II 10/30/2012 II 12/23/2012 WISDOM PHARMCEUTICAL CO LTD *** PENDING FILING REVIEW *** LAURUS LABS PRIVATE LTD V 10/22/2012 III 10/16/2012 P A P III 10/16/2012 III 10/16/2012 STATUS Type SUBMIT DATE II 10/23/2012 HOLDER IOL CHEMICALS AND PHARMACEUTICALS LTD *** PENDING FILING REVIEW *** UFLEX LTD *** PENDING FILING REVIEW *** UFLEX LTD SUBJECT LANSOPRAZOLE AS MANUFACTURED IN PUNJAB, INDIA

4Q2012

PET + ALUMINIUM FOIL + POLY LAMINATES AS MANUFACTURED IN JAMMU, INDIA

PAPER + POLY + ALUMINIUM FOIL + POLY LAMINATE AS MANUFACTURED IN JAMMU, INDIA UFLEX LTD POLYAMIDE (NYLON) + ALUMINUM FOIL + PVC LAMINATE AS MANUFACTURED IN JAMMU, INDIA NORTHSTAR MEDICAL RADIOISOTOPES LLC TECHNEGEN GENERATOR SYSTEM AS MANUFACTURED IN MADISON, WISCONSIN DRONEDARONE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN JIANGSU, CHINA DOCETAXEL ANHYDROUS, USP (PROCESS-2) AS MANUFACTURED IN ANDHRA PRADESH, INDIA ASCORBIC ACID USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA VALGANCICLOVIR HYDROCHLORIDE, AMORPHOUS (DRUG SUBSTANCE) AS MANUFACTURED IN XIANJU, CHINA ADVANTAPURE SILICONE APST TUBING NI201 AS MANUFACTURED IN SHOUTHAMPTON, PA RASAGILINE MESYLATE (ESUB) AS MANUFACTURED IN GUJARAT STATE, INDIA. SILIBEADS-CERAMIC BEADS TYPE ZY AS MANUFACTURED IN WARMENSTEINACH, GERMANY EUDRAGIT L/S AS MANUFACTURED IN DARMSTADT, GERMANY PLERIXAFOR AS MANUFACTURED IN ANDHRA PRADESH, INDIA

HISUN PHARMACEUTICAL HANGZHOU CO DAPTOMYCIN (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA. LTD ZHEJIANG HISUN PHARMACEUTICAL CO LTD DONEPEZIL HYDROCHLORIDE (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA ZHEJIANG HISUN PHARMACEUTICAL CO LTD IMATINIB MESYLATE (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

PILL PACK OVERWRAP POUCH - PRINTED LAMINATION AS MANUFACTURED IN COLUMBUS, WI, STORY CITY, IA AND ROCHESTER, NEW YORK

MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN ALCANTARILLA, SPAIN ACETONITRILE HIGH PURITY GRADE (HP) AS MANUFACTURED IN GUJARAT, INDIA CONTAINER PACKAGING MATERIAL AS MANUFACTURED IN BENSHEIM, GERMANY, KUNSHAN, CINA, AND BUDAPEST, HUNGARY PEMETREXED DISODIUM HEPTAHYDRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA

Page 820

4Q2012EXCEL DMF# 26615 A 26616 A 26617 A 26618 26619 A 26620 26621 A 26622 A II 11/19/2012 BIAL PORTELA AND CA SA P III 11/16/2012 *** PENDING FILING REVIEW *** ASAHI KASEI CHEMICALS CORPORATION A II II 11/12/2012 10/29/2012 MEIJI SEIKA PHARMA CO LTD NTP RADIOISOTOPES SOC LTD III 10/30/2012 AMPACET CORP III 11/7/2012 AMPACET CORP STATUS Type SUBMIT DATE II 12/20/2012 HOLDER SUN PHARMACEUTICAL INDUSTRIES LTD SUBJECT

4Q2012

DESVENLAFAXINE FUMARATE MONOHYDRATE (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA 433548 TRANSP YELLOW SMC PP MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CATERSVILLE, GA AND HEATH, OH 466276 MYLAN BLUE SLIP PP MB AS MANUFACTURED IN TERRE HAUTE, IN, DERIDDER, LA, CARTERSVILLE, GA AND HEATH, OH ME1111 DRUG SUBSTANCE AS MANUFACTURED IN HYOGO-KEN, JAPAN FISSION IODINE-131 (PRODUCED FROM LOW ENRICHED URANIUM(LEU) NORMAL PRODUCT AS MANUFACTURED IN PRETORIA, SOUTH AFRICA TUFTEC STYRENE BLOCK POLYMER WITH 1,3-BUTADIENE, HYDROGENATED AS MANUFACTURED IN KANAGAWA, JAPAN ESLICARBAZEPINE ACETATE AS MANUFACTURED IN VISP SWITZERLAND SOFT GELATIN CAPSULE - OET-10275258 (ESUB) AS MANUFACTURED IN ST. PETERSBURG, FL

26623 26624 26625 26626 26627

A A A A A

II II IV III II III

12/31/2012 11/19/2012 11/12/2012 11/8/2012 11/15/2012 11/12/2012 11/15/2012 12/7/2012

CATALENT PHARMA SOLUTIONS LLC RAKS PHARMA PVT LTD UNGERER AND CO PRETIUM PACKAGING IOL CHEMICALS AND PHARMACEUTICALS LTD HONAM PETROCHEMICAL CORP DAESAN PLANT HONAM PETROCHEMICAL CORP YEOSU PLANT APOTEX PHARMACHEM INC *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW ***

MILNACIPRAN HYDROCHLORIDE, API AS MANUFACTURED IN ANDHRA PRADESH, INDIA ARTIFICIAL BUBBLEGUM FLAVOR FS-12019 AS MANUFACTURED IN BETHLEHEM, PA PLASTIC PACKAGING MATERICALS AS MANUFACTURED IN PARIS, ILLINOIS LAMOTRIGINE AS MANUFACTURED IN PUNJAB, INDIA POLYPROPYLENE (PP) - SB-520Y AS MANUFACTURED IN CHUNGNAM, KOREA POLYPROPYLENE (PP) - SB-520Y, SB-550Y, SB-740D, SB-750D, SFO-130A AS MANUFACTURED IN CHULLANAMDO, KOREA ADEFOVIR DIPIVOXIL AS MANUFACTURED IN ONTARIO, CANADA

26628 A 26629 A 26630 26631 26632 26633 26634 A 26635 26636 A A P P P

III II

IV II III

11/16/2012 9/27/2012 8/14/2012

BEIJING YINGMAO PHARMACEUTICAL CO LTD OLON SPA THE PAPER PRODUCTS LTD

GASTRIC FILM COATING SYSTEM AS MANUFACTURED IN BEIJING, P.R. CHINA CLOFARABINE AS MANUFACTURED IN MILAN, ITALY PRIMARY PACKAGING MATERIAL, FLEXIBLE LAMINATES SPECIALIZED POUCHES, IN 1 PLY, 2PLY, 3PLY, 4PLY, 5PLY, 6PLY AND SHRINK SLEEVES AND LABELS FOR PHARMACEUTICAL SOLID DOSAGE FORM AS MANUFACTURED IN UNION TERRITORY, INDIA

A 26637 26638 A 26639 26640 26641 26642 P A P A II 11/26/2012 II 12/21/2012 P V 11/20/2012 *** PENDING FILING REVIEW ***

FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK ABC5000 CONTRACT MANUFACTURING FACILITIES FOR THE MANUFACTURE OF LTD BIOTECHNOLOGY DRUG SUBSTANCES *** PENDING FILING REVIEW *** SIGNA SA DE CV *** PENDING FILING REVIEW *** SHASUN PHARMACEUTICALS LTD PROGESTERONE USP AS MANUFACTURED IN TOLUCA, ESTADO DE MEXICO MILNACIPRAN HYDROCHLORIDE AS MANUFACTURED IN PUDUCHERRY, INDIA

Page 821

4Q2012EXCEL DMF# 26643 26644 26645 26646 A 26647 26648 26649 26650 26651 A 26652 A 26653 26654 A 26655 26656 A 26657 26658 A 26659 A 26660 A 26661 26662 26663 26664 26665 A 26666 A 26667 26668 26669 26670 A 26671 A 26672 A II 11/20/2012 III 11/27/2012 EQUISTAR CHEMICALS LP A LYONDELLBASELL INDUSTRIES CO SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD P P P III 11/29/2012 *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** ROSELABS BIOSCIENCE LTD III 11/29/2012 ROSELABS BIOSCIENCE LTD P P A P II 12/12/2012 IV 11/30/2012 *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** SEIKAGAKU CORP *** PENDING FILING REVIEW *** CHEMPORT INC EPA960EE (ESUB) AS MANUFACTURED IN JEOLLANAM-DO, KOREA II 11/29/2012 II 4/25/2012 P II 11/15/2012 *** PENDING FILING REVIEW *** HUBEI HONGYUAN PHARMACEUTICAL CO LTD QIDONG DONGYUE PHARMACEUTICAL CO LTD FLUOROMED LP METRONIDAZOLE AS MANUFACTURED IN HUBEI PROVIENCE, CHINA ACYCLOVIR AS MANUFACTURED IN JIANGSU CHINA P II 12/21/2012 A IV II 9/28/2012 11/19/2012 II 12/26/2012 A A A A II II II II II 11/8/2012 11/29/2012 12/28/2012 12/25/2012 12/26/2012 SEVEN STAR PHARMACEUTICAL CO LTD AMOLI ORGANICS PVT LTD FRESENIUS KABI ONCOLOGY LTD FRESENIUS KABI ONCOLOGY LTD YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD SEPPIC SA SHANGHAI ZIYUAN PHARMACEUTICAL CO LTD *** PENDING FILING REVIEW *** FRESENIUS KABI ONCOLOGY LTD STATUS Type SUBMIT DATE A A A II III III III 11/26/2012 11/22/2012 11/20/2012 11/26/2012 HOLDER SANOCHEMIA PHARMAZEUTIKA AG JAPAN VILENE CO LTD AMPACET CORP STELLA KUNSTSTOFFTECHNIK GMBH SUBJECT GALANTAMINE HYDROBROMIDE AS MANUFACTURED IN NEUFELD, AUSTRIA

4Q2012

MEDICAL RELEASE LINER FILM, DL-01 AS MANUFACTURED IN SAITAMA, JAPAN 113375-K BLOMITE 75 AS MANUFACTURED IN RAYONG, THAILAND PLASTIC BOTTLE PP28, 50 ML, ACP 6031 D AN SECRO PP28 CHILDPROOF CLOSURE AS MANUFACTURED IN KASTELLAUN AND ELTVILLE, GERMANY GADOPENTETATE DIMEGLUMINE AS MANUFACTURED IN NEW TAIPEI, TAIWAN CHLORTHALIDONE USP (ESUB) AS MANUFACTURED IN GUJARAT, INDIA BUPIVACAINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN WEST BENGAL, INDIA ROPIVACAINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN WEST BENGAL INDIA ZOLEDRONIC ACID (ESUB) AS MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA DOCETAXEL TRIHYDRATE (ESUB) AS MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA SEPISPERSE LIQUID (AP, K, M, AS) AS MANUFACTURED IN CEDEX, FRANCE PHYTONADIONE USP, NON STERILE, BULK DRUG AS MANUFACTURED IN SHANGHAI, CHINA BENDAMUSTINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN WEST BENGAL, INDIA

PERFLUORO(T-BUTYCYCLOHEXANE),96.0%(TRADE NAME APF-150M) AS MANUFACTURED IN ROUND ROCK, TX

SODIUM CHONDROITIN SULFATE (ND) AS MANUFACTURED IN KANAGAWA, JAPAN

ROSE-FILL-SN-1 M1 (STERILE PRE FILLABLE GLASS SYRINGES 1.0 ML WITH STACKED NEEDLE) AS MANUFACTURED IN GUJARAT, INDIA

ROSE-FILL-LT-3.0 ML (STERILE DISPOSABLE PRE-FILLABLE GLASS SYRINGES 3.0 ML) AS MANUFACTURED IN GUJARAT, INDIA PRO-FAX SB891 POLYPROPYLENE COPOLYMER RESIN AS MANUFACTURED IN BAYPORT, TX AND LAKE CHARLES, LA ATAZANAVIR SULFATE AS MANUFACTURED IN SHANGHAI, CHINA

Page 822

4Q2012EXCEL DMF# 26673 26674 A 26675 A 26676 26677 26678 26679 26680 26681 A 26682 26683 26684 26685 26686 A 26687 26688 26689 A 26690 A 26691 26692 26693 A 26694 26695 A 26696 26697 26698 26699 26700 26701 26702 26703 26704 26705 26706 P P A P P P A A A P A II 12/24/2012 IV IV II 12/11/2012 12/11/2012 12/18/2012 IV 12/11/2012 P II 10/19/2012 *** PENDING FILING REVIEW *** ZHEJIANG XINHUA PHARMACEUTICAL CO LTD *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** FINAR LTD *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** FINAR LTD FINAR LTD NATCO PHARMA LTD *** PENDING FILING REVIEW *** MACLEODS PHARMACEUTICALS LTD RASAGILINE MESYLATE (ESUB) AS MANUFACTURED IN GUJARAT, INDIA P P II 12/21/2012 *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** NATCO PHARMA LTD II 12/19/2012 ZHEJIANG HISUN PHARMACEUTICAL CO LTD VALSARTAN (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA A A II II II 12/7/2012 12/7/2012 12/18/2012 A A A A II III II II IV 12/6/2012 12/3/2012 12/4/2012 12/7/2012 4/8/2012 AMINO CHEMICALS LTD UNIVERSAL MEDICAP LTD PIRAMAL ENTERPRISES LTD NOSCH LABS PRIVATE LTD NITIKA PHARMACEUTICAL SPECIALITIES PVT LTD HETERO LABS LTD HETERO LABS LTD A P P P P II 11/15/2012 II 12/4/2012 III 11/20/2012 HSIAO SUNG NON OXYGEN CHEMICAL CO LTD BCN PEPTIDES SA *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** LABORCHEMIE APOLDA GMBH STATUS Type SUBMIT DATE P IV 11/29/2012 HOLDER *** PENDING FILING REVIEW *** ABELEI INC SUBJECT

4Q2012

PRODUCT # 160A30 NATURAL LEMON FLAVOR AS MANUFACTURED IN NORTH AURORA, IL "O-BUSTER-E (ENZYME)' - OXYGEN ABSORBERS AS MANUFACTURED IN TAICHUNG, TAIWAN AND CHANG SU, CHINA NESIRITIDE AS MANUFACTURED IN BARCELONA, SPAIN

D-PENICILLAMINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN THURINGIA, GERMANY SAPROPTERIN DIHYDROCHLORIDE AS MANUFACTURED IN MARSA, MALTA RUBBER CLOSURES AS MANUFACTURED IN GUJARAT, INDIA IRBESARTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA PANTOPRAZOLE SODIUM, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA SODIUM STEARYL FUMARATE USP AS MANUFACTURED IN NAGPUR, INDIA IMATINIB MESYLATE (FORM-A) AS MANUFACTURED IN ANDHRA PRADESH, INDIA PACLITAXEL, USP (FORM-A) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

ZHEJIANG HISUN PHARMACEUTICAL CO LTD QUETIAPINE FUMARATE (ESUB) AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA

SORAFENIB TOSYLATE (SOT) (ESUB) AS MANUFACTURED IN ANDHRA PRADESH, INDIA

ZIDOVUDINE (NON-STERILE, BULK FORM) AS MANUFACTURED IN TAIZHOU, P.R. CHINA

CYCLOHEXANE HIGH PURITY GRADE (HP) AS MANUFACTURED IN GUJARAT, INDIA

N,N-DIMETHYL ACETAMIDE HIGH PURITY (HP) AS MANUFACTURED IN GUJARAT, INDIA BENZENE SULPHONIC ACID HIGH PURITY (HP) AS MANUFACTURED IN GUJARAT, INDIA BENDAMUSTINE HYDROCHLORIDE (ESUB) AS MANUFACTURED IN TAMILNADU, INDIA

Page 823

4Q2012EXCEL DMF# 26707 A 26708 26709 26710 26711 26712 A 26713 26713 26714 26715 26716 26717 26718 26719 26720 26721 26722 26723 26724 A 26725 26726 26727 A 26728 A 26729 A 26730 A 26731 A 26732 A 26733 26734 26735 26736 26737 A P P A A III IV 12/17/2012 12/10/2012 IV 12/12/2012 III 12/6/2012 III 12/18/2012 III 12/12/2012 IV 12/12/2012 II 12/14/2012 A P II 11/5/2012 II 11/28/2012 STERLING SPA *** PENDING FILING REVIEW *** SHAANXI HUIFENG PHARMACEUTICAL LTD C C P P A P P P P P A P II 11/28/2012 II 12/29/2012 II 12/11/2012 IV IV 11/8/2012 11/8/2012 A P A P II 12/6/2012 IV 12/11/2012 II 12/11/2012 ITF CHEMICAL LTDA *** PENDING FILING REVIEW *** MK SILICONE PRODUCTS PVT LTD *** PENDING FILING REVIEW *** ZHEJIANG XINHUA PHARMACEUTICAL CO LTD MB SUGARS AND PHARMACEUTICALS LTD MB SUGARS AND PHARMACEUTICALS LTD *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** BCN PEPTIDES SA *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** SUN PHARMACEUTICAL INDUSTRIES LTD *** PENDING FILING REVIEW *** SIGMUND LINDNER GMBH SILIBEADS - CERAMIC BEADS TYPE ZY PREMIUM AS MANUFACTURED IN WARMENSTEINACH, GERMANY ABIRATERONE ACETATE AS MANUFACTURED IN PERUGIA, ITALY FEBUXOSTAT (ESUB) AS MANUFACTURED IN MAHARASHTRA, INDIA LEUPROLIDE (LEUPRORELIN) AS MANUFACTURED IN BARCELONA, SPAIN LEVOFLOXACIN AS MANUFACTURED IN TAIZHOU, P.R. CHINA CONFECTIONERS SUGAR (USP) AS MANUFACTURED IN MAHARASHTRA, INDIA CONFECTIONERS SUGAR (USP) AS MANUFACTURED IN MAHARASHTRA, INDIA SILICONE TRANSPARENT TUBING AS MANUFACTURED IN MUMBAI, INDIA STATUS Type SUBMIT DATE III 12/10/2012 HOLDER LOPAREX BV SUBJECT

4Q2012

RELEASE LINER BASED ON POLYESTER WITH 1 OR 2 SIDES SOLVENT LESS SILICONE COATING AS MANUFACTURED IN APELDOORN, THE NETHERLANDS DECITABINE AS MANUFACTURED IN HUBEI, PR CHINA FOR ITF CHEMICAL LTDA

RUTOSIDE TRIHYDRATE (NON-STERILE, BULK FORM) AS MANUFACTURED IN XIANYANG, CHINA CHINOIN PHARMACEUTICAL AND CHEMICAL LATANOPROST AS MANUFACTURED IN BUDAPEST, HUNGARY WORKS PRIVATE CO LTD JRS PHARMA LP PROSOLV ODT (CO-PROCESSED EXCIPIENT FOR ORAL DISSOLVING TABLET) AS MANUFACTURED IN BETHLEHEM, PENNSYLVANIA FOR JRS PHARMA LP KUNSHAN WISEPAC DESICCANT CO LTD DESICCANT (SILICA GEL WITH TYVEK 1059B AS PACKAGING MATERIALS) AS MANUFACTURED IN JIANGSU, CHINA AMERICAN PACKAGING CORP INHALATION DRUG OVERWRAP AS MANUFACTURED IN ROCHESTER, NY, STORY CITY, IA AND COLUMBUS, WI SANNER GMBH CLOSURES AS MANUFACTURED IN BENSHEIM, GERMANY, KUNSHAN, CHINA AND BUDAPEST, HUNGARY HANGZHOU GAOCHENG BIOTECH AND MICROCRYSTALLINE CELLULOSE SPHERES, USP AS MANUFACTURED IN HANGZHOU, HEALTH CO LTD CHINA *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** REXAM HEALTHCARE LE TREPORT SAS SP3 PUMPS FOR SPRAY DRUG PRODUCTS AS MANUFACTURED IN TREPORT, FRANCE HANGZHOU GAOCHENG BIOTECH & HEALTH SUGAR SPHERES, USP AS MANUFACTURED IN HANGZHOU, CHINA CO. LTD.

Page 824

4Q2012EXCEL DMF# 26738 26739 26740 26741 26742 26743 26744 A 26745 26746 26747 26748 26749 26750 26751 26752 26753 26754 26755 26757 26758 A 26759 26760 26761 26762 26763 A 26764 II 12/27/2012 SCINOPHARM TAIWAN LTD P P P P II 12/28/2012 *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** HEC PHARM USA INC P A A P P P A A A A A A II II II 12/18/2012 12/21/2012 12/28/2012 NORAC PHARMA POLYPEPTIDE LABORATORIES FRANCE ROVI CONTRACT MANUFACTURING SL ETO-10100 DRUG SUBSTANCE AS MANUFACTURED IN AZUSA, CALIFORNIA EPTIFIBATIDE AS MANUFACTURED IN STRASBOURG, FRANCE II II II III 12/20/2012 12/21/2012 12/21/2012 10/16/2012 II II 12/20/2012 12/20/2012 STATUS Type SUBMIT DATE A P P P A P IV 12/18/2012 II 12/20/2012 II 12/17/2012 HOLDER HANGZHOU HUADONG MEDICINE GROUP KANGRUN PHARMACEUTICAL CO LTD *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** LOPAREX LLC *** PENDING FILING REVIEW *** BEIJING YINGMAO PHARMACEUTICAL CO LTD *** PENDING FILING REVIEW *** HETERO DRUGS LTD HETERO DRUGS LTD *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** HETERO LABS LTD HETERO DRUGS LTD HETERO DRUGS LTD UFLEX LTD ENTERIC FILM COATING SYSTEM AS MANUFACTURED IN BEIJING, P.R. CHINA SUBJECT EVEROLIMUS AS MANUFACTURED IN ZHEJIANG, P.R. CHINA

4Q2012

FLUORINE SILICONE COATED RELEASE LINERS AS MANUFACTURED IN IOWA CITY, IA

ELTROMBOPAG OLAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA NABUMETONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA

ATORVASTATIN CALCIUM AMORPHOUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA BUPROPION HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA CYCLOPHOSPHAMIDE MONOHYDRATE, USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA PET + POLY + ALUMINIUM FOIL + POLY LAMINATE AS MANUFACTURED IN JAMMU, INDIA

STERILE WATER FOR INJECTION 10 ML PREFILLED SYRINGE AS MANUFACTURED IN MADRID, SPAIN AND BARCELONA SPAIN FOR ROVI CONTRACT MANUFACTURING SL

OLANZAPINE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN YIDU CITY, P.R. CHINA FOR HEC PHARM USA INC ROFLUMILAST AS MANUFACTURED IN JIANGSU, CHINA FOR SCINOPHARM TAIWAN LTD

A 26765 A 26766 A 26767 A 26768 26769 P P II 12/7/2012 II 12/20/2012 II 12/27/2012 ZHEJIANG XIANJU PHARMACEUTICAL CO LTD SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD *** PENDING FILING REVIEW *** *** PENDING FILING REVIEW *** ROCURONIUM BROMIDE USP NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN XIANJU, CHINA LUMEFANTRINE AS MANUFACTURED IN SHANGHAI, CHINA TENOFOVIR AS MANUFACTURED IN SHANGHAI, CHINA

Page 825

4Q2012EXCEL DMF# 26770 26771 26772 26773 26774 26775 STATUS Type SUBMIT DATE P A A A P A IV 12/3/2012 II II V 12/20/2012 12/20/2012 12/31/2012 HOLDER *** PENDING FILING REVIEW *** SOUVIN PHARMACEUTICAL I PVT LTD SOUVIN PHARMACEUTICAL I PVT LTD EVONIK INDUSTRIES AG WERK ROHEM *** PENDING FILING REVIEW *** HEUBACH COLOUR PVT LTD SUBJECT

4Q2012

MEFENAMIC ACID BP AS MANUFACTURED IN MAHARASHTRA, INDIA DIPHENHYDRAMINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA EUDRAGIT RL/RS DRIED ALUMINIUM HYDROXIDE GEL USP AS MANUFACTURED IN GUJARAT, INDIA

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