Professional Documents
Culture Documents
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1 I III 11/4/1947 ROHM AND HAAS CO LETHANE 384 SPECIAL
2 I II 5/8/1943 MONSANTO CO SUCCINYL SULFATHIAZOLE
5 I II 1/1/1940 NATIONAL RESEARCH COUNCIL PENICILLIN
7 I II 6/19/1943 WF STRAUB AND CO HEXESTROL
8 A IV 1/1/1950 EASTMAN CHEMICAL CO C-A-P(TM) CELLULOSE ESTER, NF
(CELLACEFATE)
9 I II 2/20/1944 NATIONAL RESEARCH COUNCIL GELATIN & OTHER BLOOD SUBSTITUTES
11 I II 3/12/1944 ROHM AND HAAS CO HYAMINE X (QUATERNARY AMMONIUM
CHLORIDE COMPOUND)
12 I II 2/21/1947 NATIONAL RESEARCH COUNCIL BAL IN OIL
13 I II 1/1/1945 YEAST PRODS INC RIBOFLAVIN, ACETYLATED
16 I II 9/1/1947 VETERANS ADMINISTRATION STREPTOMYCIN
17 I II 1/1/1940 PENICK CORP TYROTHRICIN
19 I II 1/1/1940 ABBOTT LABORATORIES THIOURACIL
PHARMACEUTICAL PRODUCTS DIV
21 I II 11/3/1947 MERCK AND CO INC NITROGEN MUSTARDS
22 I II 7/30/1946 DEPT DEFENSE PROTEIN HYDROLYSATES
23 I II 6/2/1946 LEDERLE LABORATORIES DIV STERILE FILLED PHARMACEUTICAL
AMERICAN CYANAMID CO PREPARATIONS
24 I II 3/22/1946 JOHNS HOPKINS HOSP P-ARSENOSOPHENYLBUTYRIC ACID
25 I II 9/12/1946 ABBOTT LABORATORIES VITAMIN K, "HYKIMONE" (ABBOTT)
PHARMACEUTICAL PRODUCTS DIV
26 I II 1/1/1946 CINBERG B L MD PROGESTERONE
28 I II 9/3/1946 BOOTS FLINT INC SUB BOOTS CO USA "AMINO ACIDS"
INC
29 I II 12/26/1946 NATIONAL RESEARCH COUNCIL SN 13,276; PALUDRINE (CHLORUGUAN); SN 12-
837
30 I II 5/22/1947 NEW YORK QUININE AND CHEMICAL METOPON
WORKS INC
31 I II 10/13/1946 STEPAN CO INC B.T.C. (A INGRED: BENZALKONIUM CHL)
32 I II 12/12/1946 SB PENICK AND CO RUTIN
33 I II 1/1/1947 UNIVERSITY OF CHICAGO DEPARTMENT CARBOWAX--POLYETHYLENE GLYCOLS &
OF MEDICINE OTHER GLYCOLS
34 I II 12/13/1946 NATIONAL INSTITUTES OF HEALTH "PALUDRINE"
CLINICAL CENTER
35 I II 2/11/1947 PARKE DAVIS AND CO ANTIMALARIAL SN 10751
36 I II 4/17/1947 UNIV MINNESOTA AMIDONE, DOLPHINE, (4,4-DIPHENYL-6-
DIMETHYLAMINO-3-HEPTANONE HCL)
39 I II 6/6/1947 DR. KARL JOHN KARNAKY STILBESTROL, INJ. & TABLETS
41 I II 10/1/1947 JOHNS HOPKINS HOSP THE ADMINISTRATION OF DI-ISOPROPYL
FLUOROPHOSPHATE (DFP) TO MAN
43 I II 1/16/1947 US PUBLIC HEALTH SERV "VIRUS, THERAPEUTIC SERUM, TOXIN
ANTITOXIN"
44 I II 12/19/1947 ICI AMERICAS INC SORBITOL, MANITOL, HEXITOL EMULSIF. AGENT-
TN: SPAN; TWEENS; ARLACEL
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SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
46 I II 2/9/1948 BATTELLE MEMORIAL INSTITUTE SELENIUM SULFIDE
48 I II 3/26/1948 LEDERLE LABORATORIES DIV LEDINAC PARENTERAL
AMERICAN CYANAMID CO
49 I II 9/10/1963 ROHM AND HAAS CO AMBERLITES IRC-50 & XE 64
54 I II 1/20/1950 WYETH INC ARTISONE ACETATE
55 I II 3/9/1950 SNYDER AND SNYDER ANTIHISTAMINE INSOMNIA TREATMENT
(MISCELLANEOUS)
59 I II 1/1/1940 PENICK CORP KHELLIN
60 I II 1/1/1950 FIRMENICH INC SOLPROTEX (DIGALLOYL TRIOLEATE)
61 I II 9/16/1963 ROHM AND HAAS CO RESINS - ION EXCHANGE AMBERLITE IRP 276
(CHOLESTYRAMINE RESIN USP)
63 I II 3/5/1951 NATIONAL INSTITUTES OF HEALTH LEVO-ISO-METHADONE
CLINICAL CENTER
64 I II 3/9/1951 LEDERLE LABORATORIES DIV GENERAL METHODS OF ASSAY AND CONTROLS
AMERICAN CYANAMID CO
68 I II 3/22/1951 UNITED STATES PHARMACOPEIA ACTH
70 I II 6/11/1951 SB PENICK AND CO CASANTHRANOL
72 I II 7/19/1951 METAL AND THERMIT CORP DIBUTYL TIN DILAURATE
73 I II 7/31/1951 PACIFIC YEAST PRODUCTS INC B 12 SSUPPLEMENT (B-MEGATHERIUM)
74 I II 7/30/1951 PERMUTIT CO PERMUTIT Z-AMMONIUM; PERMUTIT Z P-
POTASSIUM
75 I II 7/31/1951 SB PENICK AND CO VERABORE--SPECIAL AMORPHOUS ALKALOIDS
OF VERATRUM VIRIDE
76 A IV 3/10/1950 THE DOW CHEMICAL CO METHOCEL HG - HYDROXYPROPYL
METHYLCELLULOSE
77 I II 7/18/1939 SCHERING CORP CORTATE (DESOXYCORTICOSTERONE
ACETATE)
78 A IV 9/8/1966 ASHLAND LLC PLASDONE POLYVINYL PYRROLIDONE
79 I II 7/16/1951 MAYO CLINIC COMMITTEE ON SAFETY OF THERAPEUTIC
AGENTS
80 I II 10/18/1951 DIAMOND SHAMROCK CHEM CORP DIPHENYLPYRALINE (THIS D FORMERLY HELD
BY NOPCO CHEM. CO)
81 I II 8/11/1950 NATIONAL STARCH AND CHEMICAL CO DRYFLO
82 I II 1/31/1952 CHLORAMINT CO O-SILVER ANTISEPTIC DISPOSABLE DIAPERS &
ANTISEPTIC SURGICAL DRESSING
84 I II 1/1/1940 NATIONAL RESEARCH COUNCIL PLASMA EXPANDERS
86 I II 1/1/1940 DEPT DEFENSE PRIMAQUINE
88 I II 1/1/1940 PLAVOLEX PLAVOLEX (PLASMA VOLUME EXPANDER)
89 I II 4/4/1979 ER SQUIBB AND SONS INC NYDRAZID
90 I II 3/4/1954 WORTHINGTON BIOCHEM CORP HYALURONIDASE
92 I II 5/9/1952 A MASCHMEIJER JR INC ISONICOTINIC ACID HYDROZIDE
93 I II 6/23/1952 EI DUPONT DE NEMOURS AND CO INC ALATHON (POLYTHENE RESIN)
94 I II 5/19/1952 NIPA LABORATORIES INC OTTAFECT AND OTTASEPT
98 I II 1/1/1940 PFIZER INC LUDOX
100 I IV 6/2/1965 BASF CORP PLURONICS (L62 F68) L44 PLURONIS POLYOLS
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SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
101 I I 8/26/1952 PARKE DAVIS & CO GENERAL METHODS OF MANUFACTURE $
CONTROL
103 I II 9/16/1952 SB PENICK AND CO AQUEESTROL
105 I II 1/1/1940 NATIONAL INSTITUTES OF HEALTH DARAPRIM (PYRIMETHAMINE)
CLINICAL CENTER
106 I II 2/3/1953 ROUSSEL CORP CORTISONE ACETATE
107 I II 12/16/1952 DEXTRAN CORP PLASMA EXPANDERS
108 I II 3/18/1953 NORDA ESSENTIAL OIL AND CHEMICAL DICHLOROSAN
CO INC
110 I II 5/29/1953 SB PENICK AND CO NEOMYCIN SULFATE USP
112 I II 5/21/1953 TERRA CHEMICALS INC AEROSIL
114 I II 7/3/1953 RT VANDERBILT CO INC VANCIDE 89 (CAPTAN)
115 I II 7/5/1953 SARATOGA TRADING CORP RAUWOLFIA SERPENTINA
116 I II 8/14/1953 SB PENICK AND CO PROTAVERATRINE
117 I II 9/11/1953 PASADENA RESEARCH LABORATORIES HYDROCORTISONE ACETATE
INC
118 I II 5/9/1952 ER SQUIBB AND SONS INC VITAMINE B-12
121 I II 11/18/1953 NORDA ESSENTIAL OIL AND CHEMICAL HALOSAN
CO INC
122 I II 11/20/1953 SB PENICK AND CO PHTHALAMAQUIN
124 I II 7/23/1953 PFIZER INC NEOMYCIN SULFATE CAPS (THIS D CHANGED
TO NDA 9-579)
126 I IV 2/9/1954 DOW CORNING CORP SILICONES
128 I II 2/23/1954 GENERAL ANILINE AND FILM CORP SODIUM N-LAUROYL SARCOSINATE
131 I II 1/1/1940 CENTRAL SOYA CO INC SOYBEAN STEROL PRODUCTS
133 I II 2/10/1954 NATIONAL RESEARCH COUNCIL DRUG ADDICTION $ NARCOTICS
134 I II 9/28/1953 LIDD DAVID MD POLYVINYL PYRROLIDONE
135 I II 5/20/1954 AMGER CHEMICALS INC DEHYDROACETIC ACID
136 I II 4/27/1954 SB PENICK AND CO RESERPINE
137 I V 5/26/1954 DOW CHEMICAL CO SHORT TERM CHRONIC DIETARY FEEDING OF
METHOCEL 2602 TO RATS
140 I II 10/21/1947 SE MASSENGILL CO FACILITIES $ CONTROL
141 I II 10/6/1941 ORGANICHEM CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
144 I II 1/17/1977 US ATOMIC ENERGY COMMISSION RADIO ISOTOPES, IODINE 131 AND
PHOSPHORUS 32
146 I II 9/3/1954 3M PHARMACEUTICALS VARIOUS RAUWOLFIA SPECIES
147 I II 9/2/1954 CHAS PFIZER AND CO INC RESERPINE
148 I II 1/1/1940 IOWA STATE COLLEGE DIETHYLSTILBESTROL AS A CATTLE FEED
ADDITIVE
149 I II 9/15/1954 THOS LEEMING AND CO SUB CHAS FACILITIES ,CONTROL
PFIZER AND CO INC
150 I II 1/1/1940 OHIO AGRICULTURE EXPERIMENT MASSIVE VIT D FOR MILK FEVER PREVENTION
STATION
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SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
152 I II 10/1/1954 NATIONAL RESEARCH COUNCIL NRC.MEETING $ OTHER MEETINGS
153 A IV 9/29/1954 LUBRIZOL ADVANCED MATERIALS INC CARBOPOL 934P NF, 934 NF, 942NF, AND 940NF
POLYMER
154 I II 4/25/1955 SB PENICK AND CO RAUSERFIA TABLETS
157 I II 11/5/1954 GENERAL ELECTRIC CO SILICONES
158 I I 11/9/1954 MEER CORP RESERPINE CONCENTRATE
159 I II 11/9/1954 CORN PRODUCTS INC GLUCURONO-LACTONE $ THE SALTS OF
GLUCURONIC ACID
161 I II 1/11/1955 ROUSSEL CORP HYDROCORTISONE,FREE ALCOHOL
162 I II 1/27/1955 WORTHINGTON BIOCHEM CORP CRYSTALLINE TRYPSIN
167 I II 3/10/1958 LEDERLE LABORATORIES DIV SPECIFICATIONS AND METHODS OF ASSAY
AMERICAN CYANAMID CO
168 I II 1/1/1940 PENICK CORP UTERASE
169 I II 7/13/1955 MERCK SHARP AND DOHME RESEARCH MANUFACTURING SITE, FACILITIES,
LABORATORIES DIV MERCK AND CO INC PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
170 I IV 6/15/1955 EASTMAN CHEMICAL CO D-ALPHA-TOCOPHERYL POLYETHYLENE
GLYCOL 1000 SUCCINATE
171 I II 8/16/1955 NEW DRUG INSTITUTE RAUWOLFIA SERPERTINA WHOLE
ROOT,MANNITOL HEXANITRATE ,
175 I II 8/24/1955 MERCK AND CO INC PROCESS $ CONTROL DATE CONCERNING
MANUFACTURE OF 2-ACETYLAMINA ETC.
176 I II 1/1/1940 NEW DRUG INSTITUTE RESERPINE;PROTOVERATRINES
A&B;SUCROSE;STARCH;LACTOSE;ACACIA;MAG
NESIUM
179 I II 10/28/1955 CITRUS AND CANNED PRODUCTS ASSN HESPERDIN
180 I II 10/13/1955 NATIONAL RESEARCH COUNCIL PLASTIC BAG CONTAINERS
181 I II 1/1/1940 NEW DRUG INSTITUTE NDI FORMULA 200
183 A II 2/29/1952 ASHLAND LLC POLYVINYL PYRROLIDONE-IODINE 10
185 I II 12/22/1955 ELI LILLY AND CO TOPICAL ANESTHETIC COMPOUND C-10
187 I II 1/11/1956 NEW DRUG INSTITUTE NDI. FORMULA 156
188 I I 1/20/1956 WYETH INC MANUFACTURING: METHODS AND CONTROLS
189 I II 1/1/1940 COLORADO AGRICULTURAL & DIETHYLSTILBESTROL IN CATTLE FEEDS
MECHANICAL COLLEGE --SAFETY OF USE OF
190 I I 1/24/1956 ABBOTT LABORATORIES SYSTEMS FOR THE CONTROL OF
PHARMACEUTICAL PRODUCTS DIV MANUFACTURE PROCESSING $ PACKING OF
DRUGS
191 A II 1/24/1956 SPECGX LLC PARZONE BITARTRATE (DIHYDROCODEINE
BITARTRATE)
192 I II 2/2/1956 MALLINCKRODT INC RESERPINE
193 I II 2/17/1956 FINE CHEMICALS CANADA LTD RESERPINE
194 I I 2/16/1956 PENNWALT CORP CONTROL PROCEDURES MANUFACTURING
196 I II 5/1/1956 INSTITUTE STUDY ANALGESIC REPORT OF MEETING
SEDATIVE DRUGS
197 I II 5/2/1956 UPJOHN CO ORINASE
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SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
199 I II 1/1/1940 NEW DRUG INSTITUTE HYDROCORTISONE
200 I II 3/29/1956 LEDERLE LABORATORIES DIV ESKASUL MANUFACTURING DETAILS
AMERICAN CYANAMID CO
201 I II 1/1/1940 PENICK CORP GRAMICIDIN
202 A IV 3/4/1964 INTERNATIONAL FLAVORS AND ALVA FLAVORS, SEALVA FLAVORS
FRAGRANCES INC
203 I II 1/1/1940 ER SQUIBB AND SONS INC STILBETIN SUPPLEMENT 50
(DIETHYLSTILBESTROL IN POLYETHYLENE
GLYCOL)
207 I II 5/9/1956 NEW YORK QUININE AND CHEMICAL DIHYDROCODEINE BITARTRATE ANHYDROUS
WORKS INC
208 I II 5/24/1956 BRISTOL LABORATORIES INC DIV TESTING FACILITIES FOR RAW MATERIALS &
BRISTOL MYERS CO FINISHED GOODS
209 I II 5/23/1956 UPJOHN CO COMBINED ADRENAL HORMONE ANTIBIOTIC
THERAPY
210 I II 5/26/1959 SB PENICK AND CO RAUNORMINE
211 I II 1/1/1940 MALLINCKRODT INC FERROUS FUMARATE "TOLERON"
212 I II 1/1/1940 PHARMACRAFT INC ZIRCONIUM
213 I II 7/13/1956 SOCIETE DES LABORATOIRES LABAZ SULFANILAMIDE -2,4-DIMETHOXY-5-TRIAZINE
(HB-182)
214 I II 1/1/1940 SOCIETE DES LABORATOIRES LABAZ CARNITINE CARNITINATE DICHLORIDE
215 I II 5/21/1965 ARCHIMICA LTD TCC TRICLOCARBAN (3,4,4'-TRICHLORO
CARBANILIDE)
216 I II 7/16/1956 PHARMACEUTICAL PRODUCTS CO INC A DESCRIPTION OF THE FACILITIES &
OPERATING PROCEDURES
217 I II 7/9/1956 SUMNER CHEMICAL CO INC POTASSIUM PARA AMINOSALICYLATE
218 I II 1/1/1940 LEDERLE LABORATORIES DIV STYLOMYCIN (PUROMYCIN)
AMERICAN CYANAMID CO
219 I II 12/8/1958 ANHEUSER BUSCH INC VITA-BUSCH-12 CONCENTRATE
220 I II 7/23/1956 FRANK SAMUEL AND CO INC POWDERED WHOLE RAUWOLFIA SERPENTINA
ROOT
221 I II 7/18/1956 GALAT ALEXANDER N-(3'DIMETHYLAMINO)PROPYL PHENOTHIAZING
HCL (PROMAZINE HCL)
222 I II 8/7/1956 SB PENICK AND CO AMMOIDIN (8-METHOXYPSORALEN,
XANTHATOXIN)
223 I II 8/6/1956 SOCIETE DES LABORATOIRES LABAZ SODIUM DI-TERTIARY BUTYL-NAPHTHALENE
SULFONATE
225 I II 1/1/1940 ABBOTT LABORATORIES DIETHYLSTILBESTROL PWD &
PHARMACEUTICAL PRODUCTS DIV DIETHYLSTILBESTROL 50% SUSPEN. IN
SOYBEAN OIL
226 I II 5/24/1956 BRISTOL LABORATORIES INC DIV CALCIUM AMPHOMYCIN OINTMENT
BRISTOL MYERS CO
227 I II 4/8/1957 ELI LILLY AND CO CHLORDIETHYLNOL (DIETHYL CHLORO
ETHYNYL CARBINOL)
229 I II 1/1/1940 NEW YORK ACADEMY SCIENCES MEETINGS, MISCELLANEOUS
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SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
230 I II 1/1/1940 CHEMO PURO G CO PIPERAZINE PREPARATIONS
232 I II 11/1/1956 PENCO OF LYNDHURST INC METHOCARBAMOL
233 I II 1/1/1940 WALLERSTEIN TYROTHRICIN & GRAMICIDIN
234 I II 12/11/1956 SYNTHETIC FERTILIZERS AND p HYDROXYPHENYLSALICYLAMIDE
CHEMICALS INC
235 I II 1/1/1940 CARBIDE AND CARBON CHEMS CO DIV PIPERAZINE, TECHNICAL
UNION CARBIDE AND CARBON COR
238 I II 11/2/1956 ELLAY RUBBER CO DIV WR GRACE AND VINYL SHEETING & GRANULES - 0445X3
CO
239 I II 2/8/1957 GANE AND INGRAM INC BENACTYZINE HCL
240 A II 1/11/1957 DR REDDYS LABORATORIES LTD NORETHINDRONE
241 I II 1/29/1957 SYNTEX LABORATORIES INC SUB PREDNISONE, CRUDE AND CRYSTALLINE
SYNTEX CORP
242 I II 1/1/1940 APOTHEKERNES LABORATORIUM AS NEOMYCIN SULFATE
243 I II 2/7/1957 ARMOUR LABORATORIES DIV ARMOUR 3,3' - ALLYLDIETHYLSTILBESTROL & 3,3' - ALLYL
PHARMACEUTICAL CO HEXESTROL
244 I II 1/1/1940 ARMOUR LABORATORIES DIV ARMOUR VITAMIN B12 CONC. (FEED GRADE
PHARMACEUTICAL CO MILORGANITE) (VET MED)
249 I II 3/14/1957 ER SQUIBB AND SONS INC PACKAGING OF SQUIBB
RADIOPHARMACEUTICALS
250 I II 1/1/1940 JENSEN-SALSBERY LABS DIV XYLOCAINE
RICHARDSON-MERRILL INC
252 I II 1/1/1940 JENSEN-SALSBERY LABS DIV SODIUM POLYTHIONATE SOLUTION (VET MED)
RICHARDSON-MERRILL INC
253 I II 4/27/1957 MERCK AND CO INC AQUEOUS SOLN RADIO-A VITAMIN B12
254 I IV 4/4/1957 CLINCAL TECHNOLOGY DIVISION OF IONAC C-269
SYBRON CORP
255 I II 5/1/1957 SOCIETE DES LABORATOIRES LABAZ ADRENOCHROME MONO SEMI CARBAZONE
256 I II 1/1/1940 FERRING AB TRICORTAN (VET MED)
258 I I 5/23/1967 GENERAL PACKAGING SERVICE MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
259 I II 6/13/1957 SYNTEX LABORATORIES INC SUB "HORMONE COCKTAIL"
SYNTEX CORP
260 I II 7/9/1957 ROUSSEL CORP PREDNISONE
261 I II 5/15/1957 ROBECO CHEMICALS INC ROBANE
262 I II 1/1/1940 UPJOHN CO NEOMYCIN SULFATE 0.5GM, COMMERICIAL
GRADE, NOT USP
263 I III 6/18/1957 ROHM AND HAAS CO POLYMER MC 2242
264 I II 7/26/1957 SB PENICK AND CO NEOMYCIN PALMITATE
265 I II 1/1/1940 RHODIA INC HYDROCHLORIDE 6484 R.P. (VET MED)
266 I II 1/1/1940 JENSEN-SALSBERY LABS DIV STEROSAN (VET MED)
RICHARDSON-MERRILL INC
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SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
267 I II 8/21/1951 IVERS LEE DIV BECTON DICKINSON AND MANUFACTURING SITE, FACILITIES,
CO PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
268 I II 1/1/1940 RHODIA INC PIPERAZINE DIHYDROCHLORIDE AMMONIUM)
RHODEX (VET MED)
269 I II 9/25/1957 NORDA ESSENTIAL OIL AND CHEMICAL BIS (2-HYDROXY-5-CHLORO PHENYL) SULFIDE
CO INC
270 I II 1/1/1940 CHAS PFIZER AND CO INC NEOMYCIN SULFATE (VET MED)
271 I II 1/1/1940 MERCK AND CO INC NEOMYCIN SULFATE
272 I II 1/1/1940 NEW YORK QUININE AND CHEMICAL HYDROCORTISONE, HYDROCORTISONE
WORKS INC ACETATE & CORTISONE ACETATE
273 I II 9/3/1957 DOW CHEMICAL CO DISIDIUM DIHYDROGEN VERSENATE, A.R.
274 I II 1/1/1940 F.X. GASSNER, COLORADO STATE TESTOSTERONE & DIETHYLSTILBESTROL-
UNIVERSITY CATTLE FEED MIXED W/INGREDS--SAFETY?
275 I II 1/1/1940 ABBOTT LABORATORIES DEXOXYEPHEDRINE HCL
PHARMACEUTICAL PRODUCTS DIV
276 I II 11/1/1957 SYNTEX SA PREDNISOLONE
278 I II 10/28/1957 ORTHANA KEMISK FABRIK A S CORTICOTROPIN - GEL
279 I II 8/8/1960 GENERAL MILLS INC L-ARGININE MONHYDROCHLORIDE AND L-
ARGININE AND L-GLUTAMATE
280 I II 11/19/1957 SYNTEX SA 17a - ACETOXY PROGESTERONE
281 I II 11/21/1957 MEDA PHARMACEUTICALS INC 2 HYDROXY-METHYLENE-17 ALPHA METHYL-
DIHYDRO-TESTOTERONE
282 I II 11/14/1957 PETER HAND FDN VITAMIN A-DESOXYCHOLIC ACID COMPLEX
283 I II 12/5/1957 NEW DRUG INSTITUTE SYNTHESIS OF RESPERINE
284 I II 12/18/1957 SB PENICK AND CO RESCINNAMINE
285 I I 1/16/1965 SPARKS CORP PROCEDURE FOR HANDLING MEDICAL TABLETS
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DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
297 I II 5/19/1958 LEDERLE LABORATORIES DIV SULFACHLOROPYRAZINEM - R & SPECS
AMERICAN CYANAMID CO
298 I II 5/22/1958 SOCIETE DES LABORATOIRES LABAZ PROPYNYL CYCLOHEXANOL CARBAMATE
299 I II 1/1/1940 JENSEN-SALSBERY LABS DIV DEQUADIN (COMMON NAME DEQUALINIUM
RICHARDSON-MERRILL INC CHL)
300 I II 1/1/1940 JENSEN-SALSBERY LABS DIV TEOQUIL
RICHARDSON-MERRILL INC
301 I I 6/23/1958 HOFFMANN LA ROCHE INC FACILITIES AND CONTROLS --TRETINOIN
302 I V 7/16/1958 JENSEN-SALSBERY LABS DIV SOMATOTROPIC HORMONE - JOURNAL
RICHARDSON-MERRILL INC REFERENCES
303 I II 8/29/1958 ELI LILLY AND CO 1 - CYCLOPPENTYL - 2 - AMINO PROPANE
304 I II 9/18/1958 UPJOHN CO CHLORPROPAMIDE TABLETS-PHARMACOLOGY,
CLIN RPTS,G'S PROCEEDS. & CNTRL
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DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
330 I II 3/4/1959 MONSANTO CO HEMA (HYDROLYZED ETHYLENE MALEIC
ANHYDRIDE) RESIN
331 I II 3/31/1959 PABST LABORATORIES DIV PABST ZYMO-PABST
BREWING CO
332 I II 4/14/1959 UPJOHN CO SOLKETAL (GLYCEROL 1,2 - ISOPROPYLIDENE
ETHER)
333 I II 4/13/1959 SOLVAY PHARMACEUTICALS DUVADILAN (ISOXSUPRINE HCL)
334 I II 4/20/1959 ELI LILLY AND CO MYRISTYL - 3 - HYDROXYBUTYLAMINE HCL -
COMPOUND 06537
335 I II 1/1/1940 NOVO NORDISK AS AMYLASE CONCENTRATE, CRUDE BACTERIAL
336 I II 5/18/1959 CHEMICALS INC IRON - HYDRODEXTRAN
337 I II 1/1/1940 RHODIA INC SPIRAMYCIN--G PROCEDURES
338 I IV 6/23/1959 KNOLL PHARMACEUTICAL CO UNIT DONDREN (MINERAL OIL)
BASF K&F CORP
339 A II 7/8/1959 SOLVAY USA INC IGEPAL® CO-630 SPECIAL USP
340 I II 7/13/1959 UPJOHN CO STYRENE - MALEIC ACID COPOLYMER-TOXIC.
DATA, CLIN REPTS & PHYSI CHARAC
341 I II 8/6/1959 STECKER CHEMICALS INC ASC-4, BRAND OF DIAPHENE
342 I II 8/16/1959 KV PHARMACEUTICAL CO NOLAMINE REPEAT ACTION TABLETS
343 I II 8/18/1959 SB PENICK AND CO PHOLCODINE - R' & SPECS
345 I II 9/10/1959 AVECIA INC SDM-40 (25% ISOSORBIDE DINITRATE IN
LACTOSE)
346 I II 9/4/1959 MINERALS AND CHEMICALS PHILIPP PHARMASORB - REGULAR & COLLOIDAL
CORP
347 I II 10/14/1959 MONSANTO CO SANTOPHEN 1, o-BENZYL-p-CHLOROPHENOL
348 I V 10/19/1959 WARNER LAMBERT CO LLC PARENTERAL MANUFACTURE
349 I II 10/16/1959 ARMOUR PHARMACEUTICAL CO MANUFACTURING CONTROL PROCEDURES
350 I II 11/2/1959 SB PENICK AND CO INOSITOL HEXANICOTINATE
351 I II 11/2/1959 PRINCETON LAB PRODS CO TRYPSIN, CHYMOTRYPSIN & RIBONUCLEASE -
'G PROCEDURES & ASSAYS
352 I II 11/16/1959 ELI LILLY AND CO VORTEL TABLETS
353 I II 11/16/1959 PHARMACIA LABORATORIES INC LOW MOLECULAR DEXTRAN
354 I II 12/2/1959 WALLERSTEIN ENZYMES
356 I II 12/17/1959 AMERICAN CYANAMID CO NEOMYCIN BASE - 'G PROCEDURES & SPECS
357 I II 1/6/1960 HELENA RUBINSTEIN INC WHITE MAGNOLIA PERFUME OIL, FORMULATION
358 I II 1/13/1960 SYNTEX LABORATORIES INC SUB 6A - CHLORO - PREDNISONE ACETATE (G
SYNTEX CORP PROCEDURE & SPECS)
359 I II 1/21/1960 EASTMAN CHEMICAL CO MYVACET
360 I II 1/21/1960 ROBAPHARM LTD ROBUDEN - 'G PROCEDURES & SPECS
362 I II 1/27/1960 EATON LABS DIV NORWICH PHARMACAL NIDRAFUR MIX
CO
363 I I 2/5/1960 KNOLL PHARMACEUTICAL CO UNIT G PROCEDURES, & CONTROLS
BASF K&F CORP
364 I II 2/8/1960 WALLERSTEIN AMYLOLYTIC AND PROTEOLYTIC ENZYMES
Page 9
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
365 I IV 3/3/1960 RHONE POULENC PHARMACEUTICALS EMULPHOR EL - 620 & EL - 719
DIV RHONE POULENC INC
366 I II 2/16/1960 KV PHARMACEUTICAL CO PYRILAMINE - PHENYLEPHRINE SUSTAINED
ACTION CAPSULES
367 I II 2/17/1960 WAITAKI INTERNATIONAL BIOSCIENCES TRYPSIN & a - CHYMOTRYPSIN - PREPARTION &
SUB WAITAKI CANADA LTD ASSAY METHODS
368 A IV 2/24/1960 GIVAUDAN FLAVORS CORP FLAVOR FORMULATIONS
371 I III 3/14/1960 REED LANE INC CONTRACT PACKAGING FACILITIES LOCATED IN
WAYNE, NJ
373 I II 3/23/1960 WORTHINGTON BIOCHEM CORP DESOXYRIBONUCLEASE, PANCREATIC
374 I II 3/31/1960 SB PENICK AND CO PHENAZOCINE HYDROBROMIDE - 'G PROCED.,
SPECS, CLIN. & TOXICITY DATA
375 I II 4/5/1960 JOHN MANVILLE PRODUCTS CORP MICRO-CEL & CELKATE
376 I II 4/28/1960 ROUSSEL CORP DESERPIDINE SYNTHETIC
377 I II 4/29/1960 ROYAL NETHERLANDS FERMENTATIONS PIMARICIN
LTD
378 I II 5/16/1960 ELI LILLY AND CO IMIDAZOLIUM BROMIDE DERIVATIVE
379 I V 5/25/1960 HESS AND CLARK CO DIV RICHARDSON- NIHYDRAZONE - FIELD RESEARCH DATA
MERRELL INC
380 I II 6/6/1960 LEDERLE LABORATORIES DIV FORMULAE FOR VARIOUS STANDARD COATING
AMERICAN CYANAMID CO SOLUTIONS ,LAKEDYE
382 I II 6/16/1960 ELI LILLY AND CO TYLOSIN
383 I II 6/27/1960 REYNAUD LTD PERBRO CLOUD
384 I II 7/5/1960 SANOFI AVENTIS CHIMIE 1-(A-HYDROXYETHYL)-2-METHYL-5-NITRO-
IMIDAZOLE,A NEW TRICHOMONOCIDE
385 I II 7/7/1960 WYETH-AYERST LABORATORIES DIETHYLSTILBESTROL IMPLANTATION PELLETS
386 I II 6/27/1960 ABBOTT LABORATORIES GALLIMYCIN -10+ ZOALENE
PHARMACEUTICAL PRODUCTS DIV
387 I II 7/11/1960 NORWICH PHARMACAL CO FURALTADONE MASTITIS PREPARATION -
SQUEEJET DISPENSER
389 I II 7/15/1960 RP SCHERER CORP FERROUS CITRATE
390 I II 1/17/1960 DRAGOCO INC AZULENE
391 I II 7/18/1960 DOLE CO BROMELAIN - COMMERICAL GRADE 'G
PROCEDURES
392 I II 7/25/1960 SYNTEX LABORATORIES INC SUB G OF BULK--19-NOR-17a-ETHINYL-
SYNTEX CORP TESTOSTERONE-17B-MONOENANTHATE
393 I I 8/1/1960 MCMILLEN FEED MILLS METHODS IN FACILS & CONTROLS FOR THE G,
PROCESSING, PACK. OF DRUGS
394 I I 8/2/1960 GENERAL MILLS INC METHODS FACILS & CONTROLS - FOR G
PROCESSING & PACK. OF DRUGS.
395 A II 8/10/1960 DSM NUTRITIONAL PRODUCTS INC 5% D-METHORPHAN HYDROBROMIDE
ADSORBATE POWDER
396 I II 1/1/1940 BIO-RAMO DRUG CO INC IRON POLYSACCHARIDE RAW MATERIAL USED
IN G OF DI-FERRON INJECTION
Page 10
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
397 I II 9/6/1960 SHARP CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CONSHOHOCKEN,
PENNSYLVANIA.
398 I II 9/19/1960 UPJOHN CO MANUFACTURING ,PACKAGING AND CONTROLS
PROCEDURES-THIS IS A VET MED D
399 I IV 10/3/1960 EMERY PERSONAL CARE PRODUCTS NIMLESTROL; LANFRAX; LANTROL; LANFRAX
GROUP WS55 (LANOLIN PRODUCTS)
401 I II 10/10/1960 CHAS PFIZER AND CO INC OLEANSOMYCIN AND COCCIDIOSTATS IN
POULTRY FEED
402 I II 1/1/1940 ICI AMERICAS INC SORBITAN MONOOLEATE (SPAN 80) (VET MED)
REFERRED TO PESTICIDE BRANCH
403 I II 10/20/1960 LEDERLE LABORATORIES DIV BIPHENAMINE HYDROCHLORIDE
AMERICAN CYANAMID CO
404 I II 10/27/1960 RHONE POULENC PHARMACEUTICALS IGEPAL CO 887 (SAME AS IGEPAL 880) CONTRLS
DIV RHONE POULENC INC & TOXICITY
405 I II 10/27/1960 RHONE POULENC PHARMACEUTICALS BIOPAL VRO-20
DIV RHONE POULENC INC
406 I II 11/7/1960 SB PENICK AND CO NEODECYLLIN (NEOMYCIN UNDECYLENATE)
407 I II 11/7/1960 WORTHINGTON BIOCHEM CORP CHYMOTRYPSIN (MANUF PROCEDURE)
408 I II 11/4/1960 WALLERSTEIN CELLASE 1000
409 I II 11/10/1960 SYNTEX SA PARAMETHASONE ACETATE--MANUF PROCEDS,
Page 11
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
427 I II 4/4/1961 DUPHAR BV DYDROGESTERONE (FORMERLY
ISOPREGNENONE)
428 I II 4/11/1961 RP SCHERER CORP FERROUS CITRATE, MANUF SPECS & CLINICAL
DATA
430 I II 4/18/1961 SB PENICK AND CO GLYCOPYRROLATE
431 I II 4/27/1961 STRONG COBB ARNER INC VICKS SINUS ANTICONGESTION "TIME COVE"
TABLETS "TRI-SPAN"
433 I II 5/12/1961 H LUNDBECK AND CO AS CALCIUM - AMPHOMYCIN
434 I II 6/22/1961 IMC CHEMICAL GROUP INC SUB TROMETHAMINE
INTERNATIONAL MINERALS CHEMICAL
CORP
435 I II 6/22/1961 RHODIA INC ETHIONAMIDE
438 I II 6/30/1961 DOW CHEMICAL CO FACILITIES & CONTROLS (METHOXY FLURANE)
440 I IV 7/12/1961 NATIONAL STARCH AND CHEMICAL CO INSTANT CLEARJEL
441 I II 7/21/1961 PRODOTTI CHIMICI DOTTORI RE MEPROBAMATE
442 I II 2/10/1961 CHEMAGRO CORP NEGUVON
444 I II 8/9/1961 LEDERLE LABORATORIES DIV SULFACHLOROPYRIDAZINE
AMERICAN CYANAMID CO
446 I II 8/28/1961 CHAS PFIZER AND CO INC L'-LYSINE MONOHYDROCHLORIDE
449 A IV 9/18/1961 DUPONT NUTRITION USA INC AVICEL MICROCRYSTALLINE CELLULOSE
453 A II 7/13/1965 FIS FABBRICA ITALIANA SINTETICI SPA NITROFURANTOIN & NITROFURANTOIN
MACROCRYSTALS
454 I II 12/7/1961 PRODOTTI CHIMICI DOTTORI RE NITROFURANTOIN
456 I II 12/11/1961 INDUSTRIA CHEMICA PRODOTTI CHLOROTHIAZIDE (BULK) -
FRANCIS SPA HYDROCHLOROTHIAZIDE
457 I I 12/12/1961 ALLIED MILLS, INC. FEED MANUF PLANTS AND CONTROL
LABORATORIES WAYNE FEEDS
458 I II 12/28/1961 RT VANDERBILT CO INC VANCIDE ZP AND VANCIDE ZP DISPERSION
459 I II 1/4/1962 RT VANDERBILT CO INC VANCIDE BL
460 I II 1/4/1962 RT VANDERBILT CO INC VANCIDE BN
461 I II 1/8/1962 RT VANDERBILT CO INC METHYL TUADS
462 I II 1/8/1962 PHARMACIA LABORATORIES INC RHEOMACRODEX
463 I II 2/6/1962 SB PENICK AND CO BENZOMETHAMINE CHLORIDE
464 I IV 2/7/1962 ELANCO PRODS DIV ELI LILLY AND CO HYGROMIX - CHICKENS
465 I II 2/6/1962 RHODIA INC PIPERACETAZINE
466 I II 2/15/1962 ALFA WASSERMANN SPA TOLBUTAMIDE BULK
467 A II 2/15/1962 FIS FABBRICA ITALIANA SINTETICI SPA CHLORDIAZEPOXIDE HCL
468 I II 2/13/1962 INDUSTRIA CHIMICA MILANESE SPA PROCHLORPERAZINE MALEATE
469 I II 2/26/1962 INDUSTRIA CHIMICA MILANESE SPA CHLORPROMAZINE HYDROCHLORIDE
470 I II 2/26/1962 SYNTEX SA 2a-METHYL-DIHYDROTESTOSTERONE
(CRYSTALLINE)
471 I II 2/26/1962 EI DUPONT DE NEMOURS AND CO INC BAYMAL COLLOIDAL ALUMINA
472 I II 3/12/1962 DOW CHEMICAL CO BROMINATED SALICYLANILIDE
473 I II 3/21/1962 STRONG COBB ARNER INC MATRIX GEL SUSTAINED RELEASE SYSTEM
Page 12
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
474 I II 3/21/1962 EI DUPONT DE NEMOURS AND CO INC TEREPHTHALIC ACID IN COMBINATION W/
TETRACYCLINES MED. TURKEY FEEDS
475 I II 3/23/1962 METAL AND THERMIT CORP STANNOUS FLUORIDE
477 I II 3/27/1962 CHAS PFIZER AND CO INC TEREPHTHALIC ACID IN POULTRY FEEDS
CONTAINING OXYTETRACYCLINE
478 I II 2/13/1962 ARAPAHOE CHEMICALS INC DIV SYNTEX HYDROXYPHENAMATE
LABORATORIES INC
479 I II 4/12/1962 RT VANDERBILT CO INC VANCIDE 2b
480 I II 4/18/1962 BAXTER LABS INC DIV TRAVENOL LABS TYROTHRICIN CHEMPLEXES
INC
482 I II 4/26/1962 ALFA WASSERMANN SPA MEPROBAMATE
484 I II 5/18/1962 PACO PACKAGING INC PHARMACEUTICAL PACKAGING OPERATION
487 I II 6/11/1962 CONTINENTAL CAN COMPANY CONALOY (EXTERNAL)
488 I II 6/12/1962 ABBOTT LABORATORIES ARSANILIC ACID (SODIUM ARSANILATE)
PHARMACEUTICAL PRODUCTS DIV
489 I II 6/8/1962 SEARLE CHEMICALS INC SUB GD ANAVAR, PESA
SEARLE AND CO
490 I II 6/22/1962 ELANCO DIV ELI LILLY AND CO CHYMOTRYPSIN TRYPSIN CRYSTALLIZED
491 I II 6/27/1962 SALSBURY LABS 3-NITRO-4-HYDROXYPHENYLARSONIC ACID
493 I II 7/6/1962 ROHM AND HAAS CO ASPERKINASE PRODUCTION
494 I II 7/20/1962 METAL AND THERMIT CORP STANNOUS OCTOATE
495 A IV 7/25/1962 MARKEM IMAJE CORP INKS USED ON CAPSULES & TABLETS
496 I II 8/15/1962 ICI AMERICAS INC STANDARD DRUG MIXTURE #35--SDM#35
498 I II 8/24/1962 YARDLEY ELECTRIC CORP AGOSAN
501 A III 10/8/1962 BD MEDICAL - PHARMACEUTICAL BD GLASS PREFILLABLE SYRINGE (PFS)
SYSTEMS
502 I II 10/10/1962 PRIVATE BRANDS CO PACKAGING AND CONTROL SPECIFICATIONS
503 I II 10/12/1962 DEPT DEFENSE 2 PAM CHLORIDE
504 I II 10/17/1962 SCHERING AG 17 ALPHA-ETHINYL-19-NOR-TESTOSTERONE
505 I II 11/14/1962 PENTAPHARM AG REPTILASE
506 I II 11/28/1962 RHODIA INC DIMETRIDAZOLE [EMTRYL]
508 I II 11/30/1962 ALLERGAN SPA 5-IODODEOXYURIDINE (5IUDR)
509 I IV 12/13/1962 DOG LIFE CORP TABLETTING MIXURE AND FLAVORING
TECHNIQUES
510 A IV 1/3/1963 THE DOW CHEMICAL CO SENTRY POLYOX WATER SOLUBLE RESINS - NF
GRADE
511 I II 12/28/1962 ROHM AND HAAS CO RHOZYME J-25 CONCENTRATE
513 I II 1/17/1963 GIST-BROCADES NV FLURANDRENOLONE ACETATE
PHARMACEUTICALS
514 I II 1/22/1963 LEDERLE LABORATORIES DIV ULTRAVIOLET ABSORBERS (U.V.Q, U.V. 24, &
AMERICAN CYANAMID CO U.V.24 PHARMACEUTICAL GRADE)
515 I II 12/19/1962 SCHERING AG 17A-ETHINYL-19-NOR-TESTOSTERONE ACETATE
Page 15
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
588 I II 6/10/1963 NATIONAL INSTITUTES OF HEALTH COOPERATIVE STUDY GROUPS OF CLINICAL
CLINICAL CENTER STUDIES PANEL
590 I II 6/21/1963 PARKE DAVIS AND CO VIRAL AND BACTERIAL VACCINES
593 I II 6/6/1963 SANDOZ PHARMACEUTICALS CORP DIV INVESTIGATIONAL DRUGS
SANDOZ INC
594 I II 7/5/1963 ROUSSEL CORP INOSITOL HEXANICOTINATE
595 I II 5/31/1963 AMERICAN CYANAMID CO CL 45,167 OR STYRYLPYRIDINIUM
(INVESTIGATIONNAL DRUG)
596 I II 5/31/1963 AMERICAN CYANAMID CO STYRYLQUINOLINIUM (CL40,001)
INVESTIGATIONAL USE
597 I II 6/13/1963 AMERICAN CYANAMID CO SULFAETHOXYPYRIDAZINE W/& WITHOUT
CHLORTETRACYCTINE IN SWINE FEED EXP
598 I II 7/11/1963 NOVO INDUSTRI AS CRYSTALLINE TRYPSIN - NOVO DELETED 10 - 11
- 63
599 I IV 6/18/1963 ALBERS MILLING CO. ALBERS LAB - MIX POULTRY
600 I II 6/18/1963 LEDERLE LABORATORIES DIV TRIAMTERENE
AMERICAN CYANAMID CO
601 I II 6/27/1963 SYNTEX LABORATORIES INC SUB (VET) 6-ALPHA-9-A-DIFLUORO-16-A-METHYL
SYNTEX CORP PREDNISOLONE DESIGNATED RS 2177
602 I II 6/24/1963 AH ROBINS CO FACILITIES, METHODS AND PERSONNEL
INVESTIGATIONAL DRUG
603 I II 6/3/1963 MERCK SHARP AND DOHME RESEARCH HADACIDIN SOD. DIHYDRATE (NSC 521778) &
LABORATORIES DIV MERCK AND CO INC HADACIDIN POTASS. NSC 72962
Page 16
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
629 I II 8/8/1963 ABBOTT LABORATORIES 2-(2-FORMYLHYDRAZINO)-4-(5-NITRO-2-FURYL)-
THIAZOLE (AS-L7665)&A-2L203
630 I II 8/12/1963 DOW CHEMICAL CO PROPYLENE GLYCOL--TRADE NAME SIRLENE
(VET)
633 I II 8/5/1963 ELANCO DIV ELI LILLY AND CO INVEST DRUG STREPTOMYCIN,TYLOSIN,
ERYTHROMYCIN & PENICILLIN BOLUS(VET)
634 I II 3/8/1963 SOLVAY PHARMACEUTICALS GENERAL INFO-DISCN. INVESTIGATIONAL
DRUGS
636 I III 8/16/1963 JT BAKER CHEMICAL CO DIETHYLPROPION
637 I II 8/15/1963 FORT DODGE LABORATORIES P-234 (INJECT. ANTHELMINTIC IN SWINE)
CALLED TRICHLORPHON & NEGUVON
640 I II 8/8/1963 HAMPSHIRE CHEMICAL CORP HAMPSHIRE NTA NA3 (TRISODIUM
NITRILOTRIACETATE MONOHYDRATE)
641 I II 7/19/1963 MERCK SHARP AND DOHME RESEARCH 1-METHYL-1-(B-CHLOROETHYL)
LABORATORIES DIV MERCK AND CO INC ETHYLENIMONIUM PICRYSULFONATE
Page 19
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
727 I II 8/8/1963 ELANCO PRODS DIV ELI LILLY AND CO TAPAZOLE AND DIETHYLSTILBESTROL FOR
CATTLE (VET)
728 I II 11/13/1963 BURROUGHS WELLCOME CO CANOPAR BRAND THENIUM CLOSYLATE (VET)
729 I V 11/4/1963 ELANCO PRODS DIV ELI LILLY AND CO INVESTIGATIONS W/SWINE FED A COMBINATION
OF TYLOSIN-STREPTOMYCIN (VET)
Page 22
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
827 I II 9/9/1964 PARKE DAVIS DIV WARNER LAMBERT METHODS, FACILS & CONTRLS
CO
828 I II 8/11/1964 RP SCHERER CORP HARDSHELL GELATIN CAPS
830 I II 8/27/1964 NYSCO LABS INC PAPAVERINE HCL-METHODS, FACIL,CONTRL-IN
GR OF T.R. CAPS
831 I II 8/21/1964 SANOFI CHIMIE TRIMEPRIMINE MALEATE
833 I II 8/7/1964 REYNAUD LTD COUGH SYRUP FLAVOR R 446
834 I II 8/13/1964 SCHUTZ AND CO MESO-INOSITOL HEXANICOTINATE
835 I II 9/9/1964 SOLVAY DUPHAR BV LACTULOSE SOLUTION
836 I IV 9/14/1964 STEPAN CO VEGETABLE OIL 1400
837 I IV 9/14/1964 STEPAN CO NEOBEE O
838 I II 9/16/1964 LAWSON PACKAGING CORP HANDLING & PACKAGING OF DRUG PRODS IN
PHARMACEUTICAL PROGRAMS
840 I II 9/3/1964 HENKEL KG AA DEPLASTOL
841 I IV 8/28/1964 STEPAN CO AR 13026 AND AR 13027
842 I IV 8/10/1964 HENKEL KG AA NASUNA A AND NASUNA B
845 I II 9/30/1964 PFIZER LABORATORIES DIV PFIZER INC ALTHIAZIDE
846 I II 10/6/1964 INTERNATL CHEM & NUCLEAR PHARMS CHROMIUM-51 (HIGH SPECIFIC ACTIVITY
INC ISOTOPE)
847 I II 10/1/1964 DRAGOCO INC PUR-CELLIN OIL, DRAGOCO
848 I II 10/15/1964 EI DUPONT DE NEMOURS AND CO INC SCIENTIFIC PERSONNEL
849 I II 6/30/1964 CHEMIRAD CORP TRIETHYLENE MELAMINE "TEM"
850 I II 10/28/1964 MEADE THOMAS J MD MARIV 240 (HIGH IODINE VALUE FISH OIL
FRACT.)-S. AFRICAN PILCHARD OIL
852 I II 11/25/1964 ABBOTT LABORATORIES IRON-58 STERILE SOLUTION
PHARMACEUTICAL PRODUCTS DIV
854 I III 11/5/1964 HOSPIRA ASHLAND FAULTLESS COMPOUNDS
855 I V 11/19/1964 PARKE DAVIS AND CO PROCEDURES
856 I IV 12/15/1964 COLONIAL SUGARS CO SUCRO SUCROSE MONOPALMITATE
CHEMICAL DIV
858 I II 11/10/1964 3M PHARMACEUTICALS MANUFACTURING AND CONTROL FACILITIES
AND PERSONNEL
859 I II 12/10/1964 WORTHINGTON BIOCHEM CORP BETA LIVER FRACTION -B
861 I II 12/22/1964 VAN DYK AND CO INC CERAPHYL 28 (CETYL LACTATE)
862 I II 12/16/1964 WHEATON SCIENTIFIC GLASS MANUF. PROCEDURES
863 A II 11/23/1964 ARCH CHEMICALS INC ZINC OMADINE
864 I II 12/21/1964 PILLSBURY CO POLYTETRAN (BRAND OF BETA-GLUCAN)
866 I II 12/2/1964 CHRISTIAN BRUNNENGRABER AND CO METHOCARBAMOL
867 I II 12/22/1964 SYNTEX SA FLUMETHASONE
868 I II 1/14/1965 SYNTEX SA FLUMETHASONE ACETATE
870 I II 1/5/1965 ROHM AND HAAS CO RHOZYME 41 CONCENTRATE
873 I II 2/15/1965 PFISTER CHEMICAL CO INC FLUOROPHENE
874 I II 1/15/1990 STOCKHOLMS GUMMIINDUSTRI AB RUBBER STOPPERS QUALITY 2213
877 I II 2/24/1965 PHILADELPHIA LABORATORIES INC MANUFACTURING AND CONTROL FOR
PRODUCTION OF MEPROBAMATE
Page 23
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
879 A III 3/15/1965 QUADRA INC RUBBER FORMULATIONS
880 I II 3/5/1965 PACKAGING COMPONENTS INC METHODS, CONTROLS AND FACILITIES
881 A II 1/2/1965 CAMBREX PROFARMACO MILANO SRL HYDROCHLOROTHIAZIDE
883 A II 3/18/1965 CAMBREX PROFARMACO MILANO SRL CHLOROTHIAZIDE
884 I II 3/31/1965 US PUBLIC HEALTH SERV INVESTIGATOR INFO
885 A III 3/29/1965 EQUISTAR CHEMICALS LP A POLYMERS FOR USE IN PACKAGING
LYONDELLBASELL INDUSTRIES CO
886 I II 4/19/1965 INOLEX CHEMICAL CO METHODS, FACILS & CONTROLS
887 I I 4/19/1965 CROWN ZELLERBACH CORP DIMETHYL SULFOXIDE (DMSO) FACILITIES
AND CONTROLS
888 I I 4/29/1965 NYSCO LABS INC FACILITIES AND CONTROLS
889 I II 5/6/1965 SHELL CHEMICAL CO HUMAN STUDIES FOR NEW DRUGS
890 I II 5/6/1965 SHELL CHEMICAL CO INVESTIGATORS FOR HUMAN STUDIES
891 I II 5/6/1965 SHELL CHEMICAL CO FACILITIES-GENERAL GR PROTOCOL AND RAW
MATERIAL CONTROLS
892 I II 5/12/1965 RHODIA INC RP 9965
893 I IV 5/13/1965 ER SQUIBB AND SONS INC SILICONE FLUIDS
896 I II 6/10/1965 VICTOR M HERMELIN CO DIV K-V PETN - BUTABARBITAL
PHARMACAL CO
897 I IV 6/9/1965 HENKEL KG AA DEHYMULS E AND DEHYMULS K
898 I II 6/9/1965 MILAN PHARMACEUTICALS INC MEPROBAMATE TABLETS
899 I II 6/24/1965 MURRAY RODERICK MD IND LISTING DIV. OF BIOLOGICS STANDARDS
900 I III 7/19/1965 AMERICAN NATIONAL CAN CO POLYOLEFIN PRODUCTS (C-70 SERIES)
901 I II 7/22/1965 ORGANON INC MESTRANOL
902 I II 7/29/1965 P L BIOCHEMICALS DIPHOSPHOPYRIDINE NUCLEOTIDE (DPN)
903 I II 8/13/1965 WALLACE LABORATORIES DIV CARTER MEPROBAMATE POWDER-WITH TRACER
WALLACE INC
904 I II 8/24/1965 DOW CHEMICAL CO TEFLURANE
905 I II 8/23/1965 GD SEARLE AND CO METHODS, FACILITIES & CONTROLS
906 I IV 8/23/1965 HENKEL KG AA DEHYDAG-PRODUCTS 1. DEHYDAG WAX O
907 I II 8/25/1965 PACIFIC BIOCHEM INC METHODS & FACILITIES
908 I II 8/28/1965 SYNTEX SA DIMETHISTERONE
909 I IV 9/2/1965 UNGERER AND CO COMPOUND FLAVOR #5218
913 I II 9/7/1965 JUNICE LABS INC CHLORPROMAZINE HYDROCHLORIDE U.S.P.
914 I II 9/15/1965 PHARMA RESEARCH CANADA LTD FLOOR PLAN ---- EQUIPMENT ---- PERSONNEL
915 I II 9/10/1965 KLINE NATHAN S MD RESEARCH INFORMATION
916 I V 9/24/1965 CIBA CORP TRICLOSAN TOXICOLOGY INFORMATION
918 I II 10/11/1965 WINTHROP PHARMACEUTICALS DIV COMPOUND 904
STERLING DRUG INC
919 I V 11/9/1965 PARKE DAVIS AND CO GYNECOLOGY BOOK
920 I II 11/17/1965 STIEFEL LABORATORIES INC SULFOXYL
921 I II 11/13/1965 CARRON PRODUCTS CO 342 RED NATURAL RUBBER COMPOUNDS AND P
& H COATING
922 I II 11/15/1965 SB PENICK AND CO QUERCETIN
Page 24
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
923 I II 11/23/1965 OWENS ILLINOIS INC PROJECT NO. 84258 EXTRACTION STUDIES
FROM TIN OXIDE COATED BOTTLES
924 I II 11/30/1965 BROCKWAY GLASS CO INC THE CHEMICAL DURABILITY OF F-GLASS
925 I II 11/24/1965 EJ TRUM INC PACKAGING CARTON MANUFACTURING
927 I II 12/8/1965 EURAND AMERICA INC ENCAPSULATION
928 I II 12/9/1965 BOEHRINGER MANNHEIM GMBH MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
929 I II 12/9/1965 PACO LABORATORIES INC PACKAGING METHODS AND FACILITIES
931 A III 12/15/1965 HOSPIRA INC PVC FLEXIBLE CONTAINER
932 A IV 12/16/1965 W R GRACE AND CO -CONN SYLOID - SILICA PRODUCTS (SILICA GEL)
933 I II 12/27/1965 ELI LILLY AND CO AMPOULES SODIUM THIOCYANATE, INJECTION
COMPOUND #23206
934 I II 12/8/1965 AYERST LABORATORIES INC DIV PREMARIN (CONJUGATED ESTROGENS-
AMERICAN HOME PRODUCTS CORP EQUINE)
937 I II 2/1/1966 TUBED CHEMICALS CORP FACILITIES & CONTROLS
938 I III 2/4/1966 EI DUPONT DE NEMOURS AND CO INC POLYETHYLENE FILM A-101 (DRUG PACKAGING)
AND MYLAR POLYESTER FILM
940 I II 2/21/1966 VYPAK CORP P-2, P-6 & P-7 POLYVINYL CHLORIDE
COMPOUNDS
941 I I 2/17/1966 CLARK ONIELL INC ASSEMBLING AND MAILING OF DRUG SAMPLE
AND LITERATURE
942 I I 2/28/1966 ARMSTRONG LABORATORIES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN WEST ROXBURY,
MASSACHUSETTS.
943 I II 2/28/1966 HENKEL KG AA PRESERVATIVE C
944 I V 2/25/1966 WARNER LAMBERT CO INVESTIGATIONAL NEWN DRUG LISTINGS
PHARMACEUTICAL RESEARCH DIV
945 I II 3/11/1966 HUMBLE OIL AND REFINING CO ISOPAR
946 I II 10/28/1965 GUARDIAN CHEMICAL CORP SURTENOL
947 I IV 2/2/1966 STANDARD AROMATICS INC IMITATION FLAVOR
949 I II 3/18/1966 DOW CHEMICAL CO ETHOXYLATED POLYETHYLENIMINE, MONTREK
600E
951 I II 3/30/1966 RHODIA INC CLOREXOLONE
952 A III 4/6/1966 KLOCKNER PENTAPLAST OF AMERICA GENOTHERM PVC FILMS
INC
953 I III 4/1/1966 CP HALL CO PARAPLEX G-50 (THIS D FORMERLY HELD BY
ROHM AND HAAS CO)
954 I II 1/6/1966 NATIONAL INSTITUTES OF HEALTH LISTING ----DIV BIOLOGICS NOTICES (IND'S)
CLINICAL CENTER
955 I II 4/19/1966 FISONS PHARMACEUTICAL LTD LOMODEX (DEXTRAN 40 INJECTION)
956 I II 4/19/1966 TRI X CORP FACILITIES AND CONTROLS
957 I II 4/22/1966 ER SQUIBB AND SONS INC FACILITIES AND CONTROLS PERSONNEL FOR
MANUFACTURE AND CONTROL
Page 25
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
958 I II 4/26/1966 SYNTEX USA INC FACILITIES AND CONTROLS
959 I II 5/6/1966 GANES CHEMICALS INC PENNSVILLE EBNZOMETHAMINE CHLORIDE
963 I II 5/5/1966 CALGON CORP DIV MERCK AND CO INC BIOCHEK 60
964 I II 5/13/1966 SCHERING AG MESTRANOL
966 I II 6/6/1966 MILES PHARMACEUTICAL DIV MILES INC CURRICULUM VITAE (PERSONNEL)
967 A IV 12/21/1965 COLORCON INC POLYVINYL ACETATE PHTHALATE
969 I II 6/22/1966 ER SQUIBB AND SONS INC SUMMARIES OF THE BACKGROUND &
QUALIFICATION OF INVEST & MONITORS
970 I II 6/23/1966 DOW CORNING CORP DOW CORNING (R) 555 FLUID
973 I II 6/22/1966 HENKEL KG AA "TEXAMID S 058 AND CUTINA OR"
974 I II 6/28/1966 SHELTERED EMPLOYMENT SERVICES FACILITIES, CONTROLS AND PROCEDURES
INC
975 I II 7/6/1966 RHODIA INC PENTAMIDINE ISETHIONATE
976 I II 7/11/1966 ATOMIC ENERGY CORP RADIOISOTOPE MASTER FILE
977 A III 7/1/1966 BAXTER HEALTHCARE CORP POLYVINYL CHLORIDE PLASTIC
978 I II 7/13/1966 VICTOR M HERMELIN CO DIV K-V NITROGLYCERIN
PHARMACAL CO
979 I III 7/12/1966 HELVOET PHARMA ITALIA SPA FORMULAS AND INGREDIENTS
980 I IV 7/16/1966 SHIONOGI QUALICAPS INC FORMULA IDENTIFICATION CODE--IDENTI-CODE
INDEX
981 I II 7/22/1966 LABORATORIES GLAXO EVANS CARRAGRRIN DERIVATIVE C.16
982 I II 7/25/1966 MARION LABORATORIES INC FACILITIES AND CONTROLS
983 I II 8/1/1966 PHARMACIA FINE CHEMICALS DEAE-SEPHADEX (C-800 074)
984 I III 8/10/1966 REYNOLDS PACKAGING LLC FOIL-VINYL SPECIFICATION
985 I II 8/15/1966 NYSCO LABS INC BROMODIPHENHYDRAMINE HYDROCHLORIDE
986 I III 8/29/1966 VCF PACKAGING FILMS INC CAST VINYL FILMS C-102 & C-105 FORMERLY
HELD BY CADILLAC PLASTIC)
987 I II 2/11/1966 SERUMWERK BASEL AG TOQUILONE COMPOSITUM
988 I II 9/14/1966 ALCON LABORATORIES INC FACILITIES AND CONTROLS
989 I V 8/25/1966 HOSPIRA INC STERILE MANUFACTURING FACILITY IN
CLAYTON NC
990 I III 10/1/1966 HOFFMANN LA ROCHE INC PACKAGING MATERIALS
991 I I 9/3/1966 HOFFMANN LA ROCHE INC RAW MATERIAL
993 I III 9/15/1966 BECTON DICKINSON AND CO PARENTOPAK PHARMACEUTICAL SYRINGE
994 I II 9/22/1966 HENKEL KG AA EDENOL BS (STEARIC ACID BUTYL ESTER)
996 I II 8/22/1966 HENKEL KG AA LUBRICANTS FOR PLASTICS
997 I I 9/20/1966 LEMMON CO FACILITIES, EQUIPMENT AND CONTROLS
998 I II 9/21/1966 MALLINCKRODT INC FACILITIES, PROCEDURES AND PERSONNEL
999 I II 9/14/1966 EJ TRUM INC FACILITIES AND CONTROLS
1001 I V 9/16/1966 SLOAN-KETTERING INST CANCER RES CLINICAL INVESTIGATORS FILE.
1003 I II 10/19/1966 NYSCO LABS INC PHENOBARBITAL TIMED RELEASE PELLETS
1006 I II 11/4/1966 NYSCO LABS INC PAVABID-PB TIMED RELEASE CAPSULES
1007 I II 11/1/1966 HOFFMANN LA ROCHE INC COMPOSITION & GR OF INJECTABLE SOLUTION
OF HEPARINOID RO 1-8307
Page 26
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1008 I III 10/31/1966 HENKEL CORP GELVA MULTIPOLYMER RESIN EMULSIONS
(GME)
1010 I II 5/20/1965 COLONIAL SUGAR REFINING CO LTD CLINICAL TESTING OF ANTI-CARIES AGENTS
1011 I II 11/21/1966 HENKEL KG AA FATTY ACIDS
1012 I II 11/18/1966 DRUG AND ALLIED PRODUCTS GUILD EFFECTIVENESS OF ANTIBIOTIC DRUGS
INC
1014 I II 12/14/1966 ER SQUIBB AND SONS INC PATIENT STARTER PACKAGES
1015 I II 12/2/1966 SCHERING AG AMIDOTRIZOIC ACID (UROGRAFIN ACID)
1016 A III 12/14/1966 CHEVRON PHILLIPS CHEMICAL CO LP MARLEX RESINS-POLYOLEFINS FOR DRUG
PACKAGING USE
1018 I IV 1/5/1967 ICI AMERICAS INC PGAC-112 (THIS D FORMERLY HELD BY
CHATTEM CHEMICALS)
1020 I I 1/13/1967 GEIGY CO SA FACILITIES AND PERSONNEL CONTROL
OPERATIONS,MANUFACTURING OPERATIONS
1021 I II 1/12/1967 NYSCO LABS INC ISOSORBIDE DINITRATE TIMED RELEASE
PELLETS
1023 A III 1/16/1967 OXY VINYLS LP POLYVINYL CHLORIDE
1025 I II 1/31/1967 VPI MIRREX CORP RP 16,091 (10-METHYL-2-PHENOTHIAZINYL)
ACETIC ACID
1026 I II 2/1/1967 ICI AMERICAS INC STANDARD DRUG MIXTURE NO. 23 (20% PETN)
1027 I II 2/2/1967 GENERAL ATOMIC ISOTOPE RESEARCH PROGRAM
1028 I II 2/6/1967 FLUORITAB CORP DURABONE #5 TABLETS (11.25MG.
SODIULUORIDE)
1029 I II 2/6/1967 FLUORITAB CORP DURABONE #10 (22.5MG SODIUM FLUORIDE)
TABLETS
1030 I II 2/6/1967 FLUORITAB CORP DURABONE # 25 (56.25MG SODIUM FLUORIDE)
TABLETS
1031 I II 2/6/1967 P L BIOCHEMICALS TRIFLUOROTHYMIDINE (F3TdR), FACILITIES AND
CONTROLS
1033 I II 3/10/1966 ER SQUIBB AND SONS INC LISTING OF INDS
1034 I II 2/16/1967 KAROLINSKA INST CHOLECYSTOKININ-PANCREOZYMIN --CCK-PZ
1035 I II 2/16/1967 CHATTEM DRUG & CHEMICAL COMPANY ALUMINUM CHLORHYDROXIDE COMPLEX ACH-
A-23
1036 I II 2/2/1967 PARKE DAVIS AND CO BENADRYL POWDER
1037 I II 3/1/1967 HOFFMANN LA ROCHE INC PROTAMINE HCL, RO 6-1588/1
1038 I IV 3/7/1967 UNKNOWN STANDARD DRUG MIXTURE NO. 24 (10% PETN-
LACTOSE MIXTURE)
1039 I II 3/9/1967 NAFTONE INC 6-AMINOCAPROIC ACID
1040 I II 3/7/1967 ATLAS CHEMICAL INDUSTRIES INC STANDARD DRUG MIXTURE NO. 16 (10%
NITROGLYCERIN-LACTOSE MIXTURE)
1041 I II 3/15/1967 VALE CHEMICAL CO INC FACILITIES, METHODS AND PERSONNEL
1042 I II 3/17/1967 MONSANTO CO POLYVINYL CHLORIDE CONTAINERS
1043 I II 3/27/1967 OLIN MATHIESON CHEM CORP SODIUM OMADINE
1044 I II 3/29/1967 LEDERLE LABORATORIES DIV SPECTRA"SORB UV 531
AMERICAN CYANAMID CO
Page 27
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1046 I II 3/27/1967 PHILLIPS PETROLEUM CO MARLEX 0202 POLYOLEFIN RESIN
1047 I III 3/31/1967 LILLY RESEARCH LABORATORIES POLYVINYL CHLORIDE CONTAINERS
1048 I II 3/24/1967 GANES CHEMICALS INC PENNSVILLE BUTABARBITAL
1049 A II 3/21/1967 SIEGFRIED USA LLC PHENOBARBITAL SODIUM USP
1050 A II 3/22/1967 SIEGFRIED USA LLC SECOBARBITAL SODIUM USP
1051 A II 3/23/1967 SIEGFRIED USA LLC AMOBARBITAL SODIUM USP
1052 I II 4/3/1967 DOW CHEMICAL CO UNS-TETRAFLUOROETHANE
1054 I II 4/21/1967 FUJISAWA PHARMACEUTICAL CO LTD SYNTHESIS OF PYRROINITRIN
1055 I II 4/25/1967 FRANK H FLEER CORP CHEWING GUM COMPOUND
1056 I II 4/26/1967 MACLIN CO MACLIN COMPOUND VM-1921---POLYVINYL
CHLORIDE ACETATE
1057 I II 5/2/1967 LEDERLE LABORATORIES DIV DICHLOROMETHOTREXATE
AMERICAN CYANAMID CO
1059 I II 5/10/1967 MICRO CHEMS LTD HYDROCHLOROTHIAZIDE USP
1060 A III 5/2/1967 KLOCKNER PENTAPLAST EUROPE MIRREX MCFD RIGID VINYL SHEET PRODS
GMBH AND CO KG
1062 I II 5/19/1967 SYNTEX CORP FREEPORT FACILITIES
1063 I II 5/29/1967 CALBIOCHEM BEHRING CORP DOPAMINE HCL
1064 I II 6/6/1967 FERRING AB ACTH
1065 I II 6/21/1967 ICI PHARMA STANDARD DRUG MIXTURE NO. 22
1066 I I 6/21/1967 SYNTEX CHEMICALS INC GENERAL MASTER FILE (THIS D FORMERLY
ARAPAHOE CHEMICALS, INC)
1067 I II 6/29/1967 ARAPAHOE CHEMICALS INC DIV SYNTEX DIMETHYL SULFOXIDE
LABORATORIES INC
1068 I II 5/6/1967 WINGENROTH LEONORA JOST STERILE PACK AND PROCESS
1069 I II 7/17/1967 MILES INC METHOXYPHENAMINE HCL
1071 I II 7/19/1967 PURDUE FREDERICK CO CLINICAL INVESTIGATORS
1072 I II 7/26/1967 EI DUPONT DE NEMOURS AND CO INC SR-87m GENERATORS
1073 I II 8/4/1967 AMOCO CHEMS CORP AFFILIATE INDOPOL POLYBUTENES
AMERICAN OIL CO
1074 I II 6/27/1967 SOLVAY PHARMACEUTICALS MANUFACTURING CONTROL INFORMATION
FOR--LITHIUM CARBONATE
1076 A II 8/15/1967 AJINOMOTO CO INC AMINO ACID PRODUCTS
1077 I II 8/25/1967 ER SQUIBB AND SONS INC MANUFACTURE OF HYDROXYUREA
1080 I II 9/7/1967 PHARMACEUTICAL FLAVOR CLINIC DIV PHARMACEUTICAL FLAVORS
FOOTE AND JENKS
1081 A III 9/6/1967 BILCARE RESEARCH AG PVC FILM
1083 I II 9/25/1967 SYNTEX USA INC RESEARCH STEROIDS
1084 I II 9/13/1967 SYNTEX USA INC NORETHINDRONE ACETATE
1085 I II 10/4/1967 AMERICAN CYANAMID CO CONSUMER PRODUCTS DIVISION
1086 I II 10/6/1967 PURDUE FREDERICK CO MANUFACTURE AND CONTROL OPERATIONS
1089 I II 10/17/1967 ABBOTT LABORATORIES MEPROBAMATE
PHARMACEUTICAL PRODUCTS DIV
1092 I II 10/24/1967 CENTURY PACKAGING CORP PACKAGING FACILITIES AND CONTROLS
1093 I II 10/25/1967 SCHERING AG ESTRADIOL ENANTHATE
Page 28
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1094 I II 10/27/1967 CHEMDEX INC IRON HY-DEX HUMAN USE
1095 I II 11/2/1967 SF DURST AND CO INC DEXAMETHASONE
1096 I II 11/8/1967 DELAWARE CITY PLASTICS CORP DIAMOND PVC-500 RESIN
1097 I II 11/9/1967 UNITED STATES DEPT ENERGY TIN-113/INDIUM-113m (D FORMERLY HELD BY
UNION CARBIDE CORP)
1098 I IV 11/17/1967 ER SQUIBB AND SONS INC PLASTIBASE (SQUIBB PLASTICIZED
HYDROCARBON GEL)
1099 I III 11/24/1967 HERCULES INC STAYBELITE RESIN
1100 I I 11/27/1967 STANDARD PHARMACAL CORP MANUFACTURING FACILITIES AND CONTROLS
1101 A III 9/11/1967 AMCOR FLEXIBLES LLC PACKAGING FILMS
1102 I II 11/30/1967 RICHLYN LABORATORIES INC FACILITIES, PERSONNEL AND CONTROLS IN
CONNECTION WITH NEW DRUGS
1103 I II 12/1/1967 PHILLIPS FILMS CO INC ELASTOTHERM F. FILM
1104 I II 12/6/1967 VICTOR M HERMELIN CO DIV K-V DRISTAN CAPSULES
PHARMACAL CO
1105 I II 12/8/1967 AYERST LABORATORIES INC DIV CF-100 OINTMENT
AMERICAN HOME PRODUCTS CORP
1108 I II 12/15/1967 DAVIES ROSE HOYT PHARMACEUTICAL MANUFACTURING, PACKAGING AND CONTROL
DIV KENDALL CO PROCEDURES
1110 I II 12/18/1967 SCHERING AG DROXONE
1111 I IV 12/12/1967 INTERNATIONAL FLAVORS AND FLAVORS
FRAGRANCES INC
1112 I II 12/20/1967 VALSPAR CORP MOBILE PACKAGING COATING FORMULATION S-
988-025
1113 I III 12/20/1967 VALSPAR CORP MOBILE PACKAGING COATING FORMULATION S-
7007-006
1115 I IV 12/28/1967 EVONIK CORP AEROSIL
1116 I II 1/2/1968 UNITED STATES DEPT ENERGY CESIUM-131 (D FORMERLY HELD BY UNION
CARBIDE CORP)
1117 I II 1/18/1967 UNITED STATES DEPT ENERGY MERCURY-197 (D FORMERLY HELD BY UNION
CARBIDE CORP)
1118 I II 12/18/1967 UNITED STATES DEPT ENERGY MERCURY-203 (D FORMERLY HELD BY UNION
CARBIDE CORP)
1119 I II 1/3/1968 UNITED STATES DEPT ENERGY IODINE-123 (D FORMERLY HELD BY UNION
CARBIDE CORP)
1120 I II 1/4/1968 REYNAUD LTD REYNO CLOUD
1121 I I 1/5/1968 GLENBROOK LABORATORIES DIV GENERAL DESCRIPTION OF FACILITIES,
STERLING DRUG INC MANUFACTURING AND CONTROLS
1122 I II 1/17/1968 UNITED STATES DEPT ENERGY MOLYBDENUM-99-P-2 (D FORMERLY HELD BY
UNION CARBIDE CORP)
1123 I II 1/17/1968 UNITED STATES DEPT ENERGY MOLYBDENUM-99-P-1 (D FORMERLY HELD BY
UNION CARBIDE CORP)
1124 I II 1/17/1968 UNITED STATES DEPT ENERGY PHOSPHORUS-32 (D FORMERLY HELD BY UNION
CARBIDE CORP)
Page 29
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1125 I I 1/10/1968 HEXAGON LABORATORIES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES .
1126 I II 1/15/1968 EI DUPONT DE NEMOURS AND CO INC "IN-113m GENERATORS"
1127 I II 1/15/1968 CILAG CHEMIE AG 3-AMINOOPROPIONITRILE FUMARATE
1128 I II 1/16/1968 ROUSSEL CORP MATHAQUALONE
1130 I II 1/22/1968 HOECHST CELANESE CORP BLOOD PLASMA TUBES (BLU 1 AND TF70)
1131 I II 1/25/1968 TROJAN POWDER CO PENTAERYTHRITOL TETRANITRATE (PETN)
1132 I II 1/24/1968 UNITED STATES DEPT ENERGY CHROMIUM-51 (D FORMERLY HELD BY UNION
CARBIDE CORP)
1133 I II 1/24/1968 MALLINCKRODT INC DIATRIZOIC ACID
1135 I II 1/30/1968 UNITED STATES DEPT ENERGY STRONTIUM-85 (D FORMERLY HELD BY UNION
CARBIDE CORP)
1136 I II 2/1/1968 UNITED STATES DEPT ENERGY IRON-59 (D FORMERLY HELD BY UNION
CARBIDE CORP)
1137 I II 1/30/1968 UNITED STATES DEPT ENERGY IODINE-131 (D FORMERLY HELD BY UNION
CARBIDE CORP)
1138 I II 2/2/1968 INTERNATL CHEM & NUCLEAR PHARMS 5-FLUOROURACIL
INC
1140 I V 2/1/1968 MERCK SHARP AND DOHME RESEARCH QUALIFICATIONS OF RESEARCH PERSONNEL
LABORATORIES DIV MERCK AND CO INC
Page 32
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1229 I II 9/4/1968 DPT LABORATORIES LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
1230 I III 9/4/1968 UNION CARBIDE CORP POLYETHYLENE RESINS (BAKELITE SERIES)
1231 I II 9/9/1968 SYNTEX LABORATORIES INC SUB 6A-FLURO-9A,11BDICHLORO-16A,17A,21-
SYNTEX CORP TRIHYDROXYPREGNA-1,4-DIENE-3, 20-DI
1232 I II 9/10/1968 UNION CARBIDE CORP BAKELITE BRAND DYNH RESIN
1233 I IV 9/11/1968 ABITEC CORP HARD BUTTER PRODUCTS
1234 I II 9/11/1968 SYNTEX LABORATORIES INC SUB D-2-(6-METHOXY-2-NAPHYTHYL) PROPIXONIC
SYNTEX CORP ACID
1236 I II 9/16/1968 EGYPTIAN LACQUER MANUFACTURING CV-1443 HEAT SEAL COATING
CO
1237 I II 9/16/1968 GANES CHEMICALS INC PENNSVILLE DIPHENHYDRAMINE HYDROCHLORIDE
1238 I II 9/19/1968 PHYTOGEN PRODUCTS INC ANAGESTONE ACETATE
1239 I III 9/17/1968 AMERICAS STYRENICS LLC BAKELITE BRAND RUBBER MODIFIED
POLYSTYRENE TMD(F) A-9501 NATURAL
1240 I IV 9/19/1968 GULF OIL CORP BAKELITE BRAND POLYSTRENE SMD(F) 3500
NATURAL
1241 A II 9/30/1968 FMC LITHIUM SUB FMC CORP LITHIUM CARBONATE
1242 A IV 10/2/1968 EVONIK NUTRITION AND CARE GMBH EUDRAGITS
1244 I II 10/18/1968 ER SQUIBB AND SONS INC DESFLUORO TRIAMCINOLONE ACETONIDE
1246 I II 10/23/1968 ROUSSEL CORP METHYLOXINE BROMOMETHYLOXINE
METHYLOXINE N-DODECYLSULFATE
1247 I II 10/21/1968 KEMKO INC MEPROBAMATE N.F.XII
1248 I II 10/23/1968 TANABE SEIYAKU CO LTD L-THREONINE
1249 I II 10/25/1968 TANABE SEIYAKU CO LTD L-METHIONINE
1250 I II 10/23/1968 TANABE SEIYAKU CO LTD L-ISOLEUCINE
1251 I II 10/25/1968 TANABE SEIYAKU CO LTD L-HISTIDINE MONOHYDROCHLORIDE
MONOHYDRATE
1252 I II 10/23/1968 TANABE SEIYAKU CO LTD L-TRYPTOPHAN
1253 I II 10/25/1968 TANABE SEIYAKU CO LTD L-VALINE
1256 I II 12/5/1968 MERRELL DOW RESEARCH INSTITUTE MANUFACTURING SITE, FACILITIES,
DIV MERRELL DOW PHARMACEUTICAL PERSONNEL, AND GENERAL OPERATING
INC PROCEDURES .
1257 I II 10/30/1968 ANABOLIC INC MANUF, CONTROL & HOUSEKEEPING
STANDARD OPER. PROCEDS, EQUIPMENT
PERSON
1258 I II 12/3/1968 ALUMINUM CO AMERICA PILFERPROOF CLOSURE (38MM) FOR STERILE
SOLUTIONS
1259 I II 12/3/1968 BECTON DICKINSON AND CO TRITIATED CYTIDINE
1260 I II 12/6/1968 NAPP CHEMICALS INC MANUFACTURE AND CONTROL OPERATIONS
1261 I II 12/13/1968 DOW CORNING CORP DOW CORNING 556 FLUID
1262 I II 12/16/1968 GENERAL ELECTRIC CO CALCIUM 45, PRODUCT SPECIFICATIONS AND
PROCESS DESCRIPTIONS
1263 I II 12/16/1968 GENERAL ELECTRIC CO CALCIUM-47
Page 33
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1264 I II 12/16/1968 GENERAL ELECTRIC CO CHROMIUM-51
1265 I II 12/16/1968 GENERAL ELECTRIC CO SELENIUM-75
1266 I II 12/16/1968 GENERAL ELECTRIC CO RUBIDIUM-86
1267 I II 12/16/1968 GENERAL ELECTRIC CO YTTERBIUM-169
1268 I II 12/16/1968 GENERAL ELECTRIC CO MERCURY-203
1269 I II 12/19/1968 BECTON DICKINSON AND CO ADENOSINE CYCLIC PHOSPHATE MANUF. BY
SCHWARZ BIORESEARCH
1270 I II 5/13/1968 BECTON DICKINSON AND CO DIBUTYRYL CYCLIC MONOPHOSPHATE SODIUM
MANUF. BY SCHWARZ BIORESEARCH
1271 A II 12/13/1968 CHATTEM CHEMICALS INC AMINOACETIC ACID (GLYCINE)
1272 I II 12/27/1968 TANABE SEIYAKU CO LTD L-ASPARTIC ACID
1273 I II 12/27/1968 TANABE SEIYAKU CO LTD L-PHENYLALANINE
1274 I II 12/31/1968 TANABE SEIYAKU CO LTD L-ARGININE MONOHYDROCHLORIDE
1275 I II 12/31/1968 TANABE SEIYAKU CO LTD L-LEUCINE
1276 I II 12/26/1968 GENERAL ELECTRIC CO IRON-59
1277 I II 12/26/1968 GENERAL ELECTRIC CO STRONTIUM-85
1278 I II 12/26/1968 GENERAL ELECTRIC CO TIN-113
1279 I II 12/26/1968 GENERAL ELECTRIC CO TIN-119M
1280 I II 11/12/1968 MILPRINT INC PHARMACEUTICAL PACKAGING MATERIAL,
NEALAM (R) 40455
1281 I III 12/2/1968 VALSPAR CORP 37 MOBIL PACKAG. COATINGS
FORMULATIONS:S-1299-
001;005;010;013;024;&030
1282 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-9658-501
1283 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-9094-001, S-9094-002
1284 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-9092-001
1285 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-9087-001
1286 I III 11/27/1968 VALSPAR CORP 37 MOBIL PAKAGING COATINGS FORMULATIONS
S-9075-001,S-9075-002,003,004
1287 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-8998-001
1288 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-8998-004
1289 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-8988-003
1290 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-8988-002
1291 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-8958-002
1292 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-8958-001
Page 34
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1293 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-8586-002
1294 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-8480-001, S-8480-002
1295 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-8327-001
1296 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-8279-001
1297 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-3208-004
1298 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING FORMULATIONS S-1961-
106, S-1961-107
1299 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-1961-101
1300 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS FORMULATS S-
1300-001,S1300-004, S-1300-009
1301 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-1299-018, S-1299-029
1302 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-1299-026
1303 I III 11/27/1968 VALSPAR CORP 37 MOBIL PACKAGING COATINGS
FORMULATIONS S-1298-001
1304 I III 12/31/1968 VALSPAR CORP MOBIL PACKAGING FORMULATION S-1167-025
1305 I II 1/6/1969 WALLERSTEIN "MICROBIAL LIPASE"
1306 I III 1/6/1969 FLINT HILLS RESOURCES LP POLYETHYLENE PE 107
1307 I III 1/13/1969 VALSPAR CORP PACKAGING FORMULATION S-6265-011
1308 I III 1/13/1969 VALSPAR CORP PACKAGING FORMULATION S-1518-016
1309 I III 1/13/1969 VALSPAR CORP PACKAGING FORMULATION S-1518-018
1312 I II 1/22/1969 UOP FRAGRANCES US PERFUME BOUQUET #15741 (ANTOINE CHIRIS)
1313 I II 1/22/1969 MILPRINT INC MILSEAL 42601
1315 I II 1/23/1969 TANABE SEIYAKU CO LTD DL-VALINE
1316 I II 1/23/1969 TANABE SEIYAKU CO LTD DL-PHENYLALANINE
1317 I II 1/23/1969 TANABE SEIYAKU CO LTD DL-TRYPTOPHAN
1318 I II 1/23/1969 TANABE SEIYAKU CO LTD DL-THREONINE
1319 I II 2/3/1969 CURWOOD INC CURWOOD'S 3802 PHARMACEUTICAL
PACKAGING FILM
1320 I II 2/10/1969 SOLVAY PHARMACEUTICALS LITHIUM CITRATE SYRUP
1323 I II 2/6/1969 PHYTOGEN PRODUCTS INC 19-NOR-17-ALPHA-ETHINYLTESTERONE
1324 I II 2/7/1969 COLONIAL SUGAR REFINING CO LTD CALCIUM SUCROSE PHOSPHATES (ANTICAY)
1325 I III 2/10/1969 EASTMAN CHEMICAL CO PROPYLENE-ETHYLENE POLYALLOMERS
(TENITE POLALLOMERS)
1326 I II 2/17/1969 MILPRINT INC MILSEAL 31100 SERIES
1327 I II 2/17/1969 MILPRINT INC MILSEAL 31600 SERIES
1328 I II 2/17/1969 MILPRINT INC MILSEAL 32000 SERIES
1329 I II 2/17/1969 MILPRINT INC MILSEAL 33200 SERIES
Page 35
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1330 I II 2/17/1969 MILPRINT INC MILSEAL 34050 SERIES
1331 I II 2/17/1969 MILPRINT INC NEALAM 43550 SERIES
1332 I II 2/17/1969 MILPRINT INC SUPEREL 55300 SERIES
1333 I III 2/17/1969 MILPRINT INC NEALAM 60550 SERIES
1334 I II 2/13/1969 MILPRINT INC NEALAM 60650 SERIES, PACKAGING MATERIALS
1335 I III 2/14/1969 ROHM AND HAAS CO ADHESIVE FORMULATIONS
1336 I III 2/24/1969 PIERCE AND STEVENS CHEMICAL CORP PROXSEAL E-9327
1347 I III 3/24/1969 PIERCE AND STEVENS CHEMICAL CORP PROXSEAL E- 9133
1349 I II 3/28/1969 SYNTEX LABORATORIES INC SUB A DESCRIPTION OF OUR CLARK, NEW JERSEY
SYNTEX CORP WAREHOUSE
1350 I II 4/24/1969 DINAMITE DIPHARMA SPA PROPOXYPHENE HYDROCHLORIDE
1351 I II 4/8/1969 ALLERGAN PHARMACEUTICAL MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF OPTHALMIC PREPS IN IRVINE,
CALIFORNIA.
1352 I II 4/14/1969 PHARMATON LTD NEO-LIDOCATION
1354 I II 6/8/1969 EL PASO POLYOLEFINS CO POLYPROPYLENE RESIN COMPOUNDS USED IN
MANUF. PLASTIC CONTAINERS
1355 I II 4/21/1969 EI DUPONT DE NEMOURS AND CO INC RUBIDIUM-84
1356 A II 3/18/1969 UNION CARBIDE CORP A WHOLLY CARBOWAX POLYETHYLENE GLYCOL
OWNED SUB OF THE DOW CHEMICAL
CO
1357 I II 4/28/1969 SYNTEX LABORATORIES INC SUB GUANADREL (CL-1388-R)
SYNTEX CORP
1358 I II 4/28/1969 EASTMAN CHEM PRODS INC TENITE POLYETHYLENE 860E-69141 WHITE
1360 I III 4/30/1969 REICHHOLD CHEMICALS INC BLACK TUBING
1361 I II 4/28/1969 RT VANDERBILT CO INC VANCIDE TBS.
1362 A III 4/24/1969 INEOS OLEFINS AND POLYMERS USA INEOS POLYETHYLENE RESIN
1363 I III 5/2/1969 CHEVRON PHILLIPS CHEMICAL CO LP POLY-ETH POLYETHELYNE 5555 RESIN
1364 I II 5/9/1969 P L BIOCHEMICALS POLYCYTIDYLIC ACID (POLY C)
1365 I II 5/12/1969 P L BIOCHEMICALS POLYINOSINIC ACID (POLYI)
1366 I III 5/5/1969 PARAMOUNT PACKAGING CORP FLEXIBLE PACKAGING MATERIALS
1367 I II 5/7/1969 LILLY RESEARCH LABORATORIES DIV LEVODOPA (COMPOUND 7550)
ELI LILLY AND CO
1368 I III 5/13/1969 VALSPAR CORP FORMULATION S-3414-102
1369 I II 5/21/1969 SOLVAY PHARMACEUTICALS SODIUM FLUORIDE TABLETS AND CAPSULES
Page 36
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1370 I II 5/28/1969 MICROBIOLOGICAL ASSOC POLYRIBOINOSINIC ACID AND
POLYRIBOCYTIDYLIC ACID
1371 I II 5/26/1969 P L BIOCHEMICALS DITHIOTHREITOL
1372 A III 5/20/1969 EI DUPONT DE NEMOURS AND CO INC SURLYN IONOMER RESINS
1373 I II 6/4/1969 PROCTER AND GAMBLE CO MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN GREENVILLE, SOUTH
CAROLINA.
1374 I II 6/9/1969 UNION CARBIDE CORP VINYLITE BRAND COATED PAPER VDI 6645
WHITE 1435
1377 I II 6/10/1969 MILPRINT INC MILSEAL 33250 SERIES
1378 A III 6/23/1969 TEKNI-PLEX INC PACKAGING FILMS AND LAMINATION, CLOSURE
LINER MATERIALS, AND LIDDING MATERIALS
1380 I II 6/26/1969 GENERAL SILICONES PARTY LTD GENSIL 39 ANTI-FOAM COMPOUND
1381 I II 7/1/1969 VICTOR M HERMELIN CO DIV K-V DARVON (PROPOXYPHENE HCL) SUSTAINED
PHARMACAL CO RELEASE CAPSULES
1382 I II 4/25/1969 REICHHOLD CHEMICALS INC RUBBER TUBING
1383 I III 6/26/1969 PRINTPAK INC LAMINATIONS AND LAMINATING PROCEDURES.
1384 I II 7/1/1969 RHODIA INC RP 4763, (SPECIA) BEMARSAL
1385 I II 7/11/1969 DELTA RUBBER CO FORMULAS #B-501, #B-502 RED BUTYL AND #R-
503, #R-505 BLUE RUBBER
1386 I II 6/27/1969 VICTOR M HERMELIN CO DIV K-V DILAC 80MG (PENTAERYTHRITOL
PHARMACAL CO TETRANITRATE RIMED DISINT CAPSULES
1387 I III 6/10/1969 REXHAM CORP LAMINATING ADHESIVE, RIEGEL CODE NO. A-
1708
1388 I II 7/14/1969 ORGANON INC ALPHA-ESTRADIOL
1389 I II 7/1/1969 HOWMEDICA INC SURGICAL SIMPLEX P AND SURGICAL SIMPLEX
RADIOPAQUE
1390 I II 7/15/1969 MONSANTO CO MONSANTO POLYETHYLENE MPE 80
1391 I II 7/16/1969 ER SQUIBB AND SONS INC D-GLUCOSAMINE HYDROCHLORIDE SOLUTION,
2N SODIUM HYDROXIDE SOLUTION
1392 A III 7/18/1969 AMCOR FLEXIBLES LLC PHARMACEUTICAL PACKAGING MATERIALS
1394 I II 7/24/1969 ROHM AND HAAS CO HYDROXYETHYL METHACRYLATE 94%
1397 I II 7/25/1969 CALBIOCHEM BEHRING CORP CYTOSINE ARABINOSIDE AND CYSTOSINE
ARABINOSINE HYDROCHLORIDE
1398 I II 7/30/1969 VICTOR M HERMELIN CO DIV K-V NEO-COROVAS TYM CAPS 30MG
PHARMACAL CO (PENTAERYTHRITOL TETRANITRATE
1400 I II 8/1/1969 UNIV WISCONSIN 25-HYDROXY-CHOLECALCIFEROL
1401 I II 8/1/1969 KEY PHARMACEUTICALS INC SUB L-DOPA
SCHERING PLOUGH CORP
1402 I II 8/1/1969 VICTOR M HERMELIN CO DIV K-V COROVAS TYMCAPS (PENTAERYTHRITOL
PHARMACAL CO TETRA NITRATE)
1403 I II 8/5/1969 DOW CORNING CORP DOW CORNING 386 FOAM ELASTOMER
1405 I II 7/29/1969 FARMITALIA SPA FORMOCORTAL
Page 37
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1406 I II 8/13/1969 PHARMACIA AND UPJOHN CORTISONE (MICRONIZED, ACETATE AND
STERILE)
1407 I II 8/12/1969 ORGANON INC ESTRIOL
1408 I III 8/20/1969 SILGAN PET CORP MONSANTO POLYETHYLENE M.P.E. 212: ALSO IN
FOOD ADDITIVE FILE #118
1411 I II 8/21/1969 GENERAL ELECTRIC CO NICKEL-63
1412 I II 9/2/1969 PHARMACIA AND UPJOHN CO WHOLLY PREDNISONE MICRONIZED, STERILIZED AND
OWNED SUB PFIZER INC ACETATE
1413 A II 9/2/1969 PHARMACIA AND UPJOHN CO LLC HYDROCORTISONE MICRONIZED AND NON-
WHOLLY OWNED SUB OF PFIZER INC MICRONIZED
1414 I III 8/27/1969 THE DOW CHEMICAL CO BAKELITE BRAND POLYETHYLENE RESIN DNDA-
01800 NATURAL 7
1415 I III 8/29/1969 ALCOA INC ALCOA NUMBERS 9003, 9004, 9005 (PHAR 9003,
9004, 9005)
1416 I II 8/29/1969 BF SCHOEN PREGNANEDIOL
1418 A II 9/4/1969 PHARMACIA AND UPJOHN CO LLC PROGESTERONE MICRONIZED AND CRYSTALS
WHOLLY OWNED SUB OF PFIZER INC
1424 A III 9/8/1969 HENKEL CORP GELVA MULTIPOLYMER RESIN SOLUTIONS
(GMS)
1425 A III 9/4/1969 SABIC INNOVATIVE PLASTICS NORYL™ RESINS
1426 I II 9/7/1969 FORNOVO FARMACHIMICI SRL IMINODIBENZYL
1427 I II 9/11/1969 ZENITH LABORATORIES INC TOLAZAMIDE POWDER
1428 I II 8/20/1969 TERRA MARINE BIORESEARCH CYTOSINE ARABINOSIDE
1429 I II 3/3/1969 VICTOR M HERMELIN CO DIV K-V ISORDIL TEMBIDS (ISOSORBIDE DINITRATE)
PHARMACAL CO SRC
1430 I II 6/10/1969 ALUMINUM CO AMERICA POLYMERIC HEAT-SEAL COATED ALUMINUM
FOIL 9403, 9404, AND 9405
1431 I II 9/16/1969 ORGANON INC ETHINYL ESTRADIOL
1432 I II 9/18/1969 PHARMACIA AND UPJOHN SUB PFIZER PREDNISOLONE USP
INC
1433 I III 9/4/1969 MILPRINT INC FLEXIBLE PACKAGING MATERIALS
1434 I II 10/6/1969 ER SQUIBB AND SONS INC PROLIXIN ELIXIR (FLUPHENAZINE
HYDROCHLORIDE)
1435 I II 10/7/1969 SCHERING AG GENERAL OPERATING PROCEDURES FOR BULK
PRODUCTS
1436 I II 10/8/1969 OLIN CHEMICAL GROUP PYRIDINETHIONE DISULFIDE (OMADINE
DISULFIDE)
1437 I II 10/8/1969 OLIN CHEMICAL GROUP 2,2' PYRIDYLDISULFIDE (2,2' PYRIDINE
DISULFIDE)
1438 I II 10/20/1969 HERCULES INC POLYMER S2062
1439 I II 10/24/1969 UNITED STATES DEPT ENERGY RADIOISOTOPE MOLYBDENUM-99-P-2
UNPROCESSED(FORMERLY UNION CARBIDE
CORP
Page 38
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1440 I II 10/29/1969 PHARMACIA LABORATORIES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PISCATAWAY, NEW JERSEY.
1442 I II 10/28/1969 ISO-MED INC SODIUM RADIOFLUORIDE
1446 I II 11/26/1969 VICTOR M HERMELIN CO DIV K-V DUOTRATE 45MG PLATEAU CAPSULES
PHARMACAL CO
1447 I II 12/3/1969 MERCK SHARP AND DOHME RESEARCH MANUF.CONTROL,FACILITIES &PROCEDURES-
LABORATORIES DIV MERCK AND CO INC AT RAHWAY, NJ PLANT
1448 I II 9/23/1969 MERCK SHARP AND DOHME RESEARCH MANUF, CONTROL FACILITIES PROCEDURES
LABORATORIES DIV MERCK AND CO INC FOR ALBANY, GA. PLANT
1449 I II 9/23/1969 MERCK SHARP AND DOHME RESEARCH MANUF. CONTROL FACILITIES & PROCEDURES
LABORATORIES DIV MERCK AND CO INC FOR DANVILLE PA PLANT
1450 I II 9/23/1969 MERCK SHARP AND DOHME RESEARCH MANUF. & CONTROL,FACILITIES &
LABORATORIES DIV MERCK AND CO INC PROCEDURES-FOR ELKTON, VA. PLANT
1451 I I 9/23/1969 MERCK SHARP AND DOHME RESEARCH MANUFACTURING, CONTROLS, FACILITIES &
LABORATORIES DIV MERCK AND CO INC PROCEDURES
1484 I II 2/12/1970 DONELAIN PHARMACEUTICALS INC PLANT FACILITIES, PERSONNEL AND CONTROL
PROCEDURES FOR DRUG ITEMS
1485 I II 2/6/1970 SCHERING AG GEN. OPERATING PROCEDS FOR BULK
PRODUCTS-SCHERING AG BERGKAMEN PLANT
1488 I II 2/13/1970 DOW CHEMICAL CO PEI 600 POLYETHYLENIMINE
1490 I II 2/18/1970 DOW CORNING CORP SILASTIC 9711 MEDICAL GRADE ELASTOMER
1492 I II 3/6/1970 ABBOTT LABORATORIES CYCLAMATE, SACCHARIN AND
PHARMACEUTICAL PRODUCTS DIV CYCLOHEXYLAMINE
1493 I IV 1/12/1970 STEPAN CO DEFOAMER FD 101, FD 102,FD 104, L-500 AND
DREWFLOC 225 AND 412
1494 I II 3/9/1970 RICHLYN LABORATORIES INC PHARMACEUTICAL MANUF, FACILITIES,
PERSONNEL AND QUALITY CONTROL
1495 I II 2/27/1970 ZENITH LABORATORIES INC MANUFACTURING FACILS, PERSONNEL AND
CONTROL PROCEDS OF NORTHVALE PLANT
1497 I II 3/19/1970 WINTHROP PHARMACEUTICALS DIV FACILITIES, METHODS AND CONTROLS
STERLING DRUG INC
1498 I I 3/9/1970 WINTHROP PHARMACEUTICALS DIV MANUFACTURING DETAILS FOR SPECIFIC
STERLING DRUG INC CHEMICALS
1499 A IV 3/6/1970 DDP SPECIALTY ELECTRONIC DOW CORNING™ 360 MEDICAL GRADE FLUID
MATERIALS US 9 LLC
1500 A III 3/12/1970 DUPONT PERFORMANCE POLYMERS A DUPONT NYLON RESIN
DIV OF EI DUPONT DE NEMOURS AND
CO
1504 I III 2/11/1970 EASTMAN CHEMICAL CO TENITE POLYPROPYLENE PRODUCTS
1505 I II 3/21/1970 BENEFICIADORA E INDUSTRIALIZADORA METHODS, FACILITIES, AND CONTROLS
SA
1506 I II 3/19/1970 MANBRITT INDUSTRY INC INJECTION BLOW MOLDING OF PLASTIC
CONTAINERS
Page 40
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1507 I II 3/27/1970 GLAXO WELLCOME INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN GREENVILLE, NORTH
CAROLINA.
1508 I II 3/25/1970 LILLY RESEARCH LABORATORIES DIV 1-METHADONE HYDROCHLORIDE
ELI LILLY AND CO
1509 I II 3/11/1970 ZENITH LABORATORIES INC PENICILLIN PLANT OPERATION IN ENGLEWOOD,
NEW JERSEY
1511 I II 4/7/1970 UNION CARBIDE CORP POLYMER JR & LR RESINS
1512 I III 4/8/1970 UNION CARBIDE CORP SHELL POLYPROPYLENES
1513 I II 4/16/1970 HERCULES INC DIVINYL ETHER-MALEIC ANHYDRIDE
COPOLYMER (ALSO CALLED PYRAN
COPOLYMER)
1514 I II 3/13/1970 SOLAR CHEMICAL CORP POLYSTYRENE RESINS
1515 I II 4/23/1970 MALLINCKRODT INC METHADONE HYDROCHLORIDE
1516 A II 4/23/1970 SANOFI CHIMIE CHLORPROMAZINE HYDROCHLORIDE
1517 I II 4/23/1970 STERLING-WINTHROP RES INST DIV AMINACRINE HYDROCHLORIDE
STERLING DRUG INC
1518 A III 4/20/1970 TOTAL PETROCHEMICALS AND ETHYLENE PROPYLENE COPOLYMER RESIN &
REFINING USA INC POLYPROPYLENE HOMOPOLYMER RESIN
1519 I II 5/4/1970 RICHLYN LABORATORIES INC FACILITIES, PERSONNEL, AND CONTROLS ON
ANTIBIOTIC DRUG PRODUCTION
1520 I II 4/28/1970 BEECHAM PHARMACEUTICALS 6-AMINOPENICILLANIC ACID
1521 I II 4/27/1970 WYETH INC MANUF FACILITIES FOR VARIOUS PLANTS OF
WYETH LABORATORIES, INC.
1522 I II 4/27/1970 WYETH INC MANUF FACILITIES FOR VARIOUS PLANTS OF
WYETH LABORATORIES, INC.
1523 I II 4/27/1970 WYETH INC GR FACILS FOR THE VARIOUS PLANTS OF
WYETH LABS INC (CHICAGO PLANT)
1524 I II 4/27/1970 WYETH INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
1525 I II 5/11/1970 ABBOTT LABORATORIES MANUF, PACKAGING AND LABELING OF BULK
PHARMACEUTICAL PRODUCTS DIV CALCIUM AND SODIUM CYCLAMATE
1526 I II 5/27/1970 ELI LILLY AND CO MANUF AND CONTROL INFOR. FOR
METHADONE HYDROCHLORIDE DISPERSIBLE
TBLS
1528 A III 5/13/1970 EI DUPONT DE NEMOURS CO DUPONT DUPONT SPECIALTY POLYETHYLENE RESINS
PACKAGING AND INDUSTRIAL
POLYMERS
1529 A IV 5/20/1970 STEPAN SPECIALTY PRODUCTS LLC WECOBEE® M
1530 I I 5/26/1970 CONCORD LABORATORIES INC MANUFACTURING AND QUALITY CONTROL
PROCEDURES
1531 I I 6/4/1970 ELKINS SINN INC SUB AH ROBINS CO CONTRACT FILLING METHODS, FACILITIES AND
CONTROLS
Page 41
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1532 I I 6/8/1970 CHASE CHEMICAL CO PHYSICAL FACILITIES, MANUFACTURING
METHODS, AND CONTROLS
1533 A III 6/4/1970 BERRY GLOBAL PLASTIC BOTTLES
1534 I II 6/1/1970 PHARMACIA AND UPJOHN CYTARABINE
1535 I II 6/11/1970 PHARMACIA AND UPJOHN SUB PFIZER MEDRYSONE
INC
1536 I II 6/9/1970 NOVO NORDISK AS BOVINE PROTEOLYTIC ENZYME MIXTURE
(BOVINE PEM) BVF 8001 70)
1537 I II 6/9/1970 NOVO NORDISK AS CRYSTALLINE TRYPSIN NOVO
1538 I II 6/23/1970 PHILLIPS PETROLEUM CO FIBER FINISH FORMULATION S-2031
1539 A III 6/17/1970 PRETIUM PACKAGING LLC PHARMACEUTICAL BOTTLES
1541 I II 6/25/1970 PHARMACIA AND UPJOHN FLUOROMETHOLONE MICRONIZED
1542 I II 6/25/1970 PHARMACIA AND UPJOHN 16-METHYLDIOLONE ACETATE AND S.D. VII)
9(11)-ANHYDRO-16a METHYLPREDNIS
1543 I II 7/7/1970 ASSIA CHEMICAL LABORATORIES LTD MANUFACTURE OF NITROFURANTOIN
1544 I II 7/14/1970 HERCULES INC HI-FAX SA 181A (A HIGH DENSITY
POLYETHYLENE-POLYPROPYLENE ALLOY)
1545 I III 8/19/1970 WEST PHARMACEUTICAL SERVICES INC RAW MATERIAL DESCRIPTIONS AND
SPECIFICATIONS FOR RUBBER FORMULATIONS
1547 I II 8/26/1970 FASSON INDUSTRIAL DIV AVERY COMPOSITION OF FASSON S-201 ADHESIVE
INTERNATIONAL
1548 I II 7/23/1970 AMSA ANONIMA MEDICINALI SINTETICI PHENYLBUTAZONE
AND AFFINI SPA
1550 I II 7/16/1970 ROUSSELL UCLAF TRIAMCINOLONE ACETATE AND
TRIAMCINOLONE (ALCOHOL)
1551 I II 6/3/1970 ROBECO CHEMICALS INC CETINATE
1553 I II 7/22/1970 PLASKON PRODUCTS INC UREA & MELAMINE FORMALDEHYDE MOLDING
COMPOUNDS (PLASKON)
1554 I II 7/29/1970 UNION CARBIDE CORP BAKELITE BRAND VINYL RESIN QMDA-4361
CLEAR 847
1555 I II 8/6/1970 EI DUPONT DE NEMOURS AND CO INC METHYL METHACRYLATE NONOMER H-112
1557 I I 8/14/1970 FISONS PLC PHARMACEUTICAL DIV MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN LOUGHBOROUGH, UNITED
KINGDOM.
1558 I II 8/7/1970 SYNTEX USA INC FA 9 ACETATE, STEROID (FLURANDRELIDE
ACETATE)
1559 I II 8/17/1970 UNION CARBIDE CORP BAKELITE BRAND OF POLYETHYLENE RESIN
DFDA-3210 NATURAL 7
1560 I II 8/20/1970 ER SQUIBB AND SONS INC TESTOLACTONE TABLETS, 250 MG
Page 42
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1561 I II 8/25/1970 ABBOTT LABORATORIES MANUFACTURING SITE, FACILITIES,
PHARMACEUTICAL PRODUCTS DIV PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ROCKY MOUNT, NORTH
CAROLINA.
1562 A III 8/26/1970 SABIC INNOVATIVE PLASTICS LEXAN™ RESINS
1563 I III 9/8/1970 FISONS CORP SPINHALER, TORBO-INSUFFLATOR DEVICE
1564 I II 9/16/1970 WINTHROP PHARMACEUTICALS DIV GR, CONTROL PROCEDURES & FACILITIES-
STERLING DRUG INC MYERSTOWN, PA., PLANT
1565 I III 9/14/1970 PHILLIPS PETROLEUM CO CLEAR POLYOLEFIN BOTTLES (CPO BOTTLES)
1566 I II 9/25/1970 BROCKTON CONTRACT PACKAGING GENERAL INFO ON PLANT, QUAL. CONTROL,
EQUIP, PERSONNEL & MANAGEMENT
1568 I II 8/3/1970 REYNAUD LTD IMITATION CITRUS FLAVOR #379LLA
1569 I III 8/28/1970 BF GOODRICH CO GEON 85658 GRADE BOTTLE COMPOUND
1570 I III 8/28/1970 BF GOODRICH CO GEON 85692 FOOD GRADE BOTTLE COMPOUND
Page 43
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1602 I II 11/4/1970 VITARINE CO INC SUB WEST CHEMICAL TABLET MANUFACTURING AND PACKAGING
PRODUCTS INC
1603 I II 10/30/1970 GANES CHEMICALS INC PENNSVILLE N,N-DIMETHOXYMETHYLPHENOBARBITAL
1604 I II 11/24/1970 LANNETT CO INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
1607 I II 11/28/1970 VITARINE CO INC SUB WEST CHEMICAL METHADONE HCL EFFERVESCENT TABLETS,
PRODUCTS INC 40MG
1608 I II 11/10/1970 BRISTOL MYERS SQUIBB CO TRIAMCINOLONE AND TRIAMCINOLONE
ACETONIDE
1614 I II 11/18/1970 ROUSSEL CORP MESTRANOL
1615 I III 11/18/1970 UNION CARBIDE CORP BAKELITE BRAND ETHYLENE ACRYLIC ACID
COPOLYMER DRDA-2300 NATURAL 7/
1616 I II 7/2/1970 DOLDER AND CO LTD CHLORPROMAZINE HCL
1617 I II 11/24/1970 ABBOTT LABORATORIES QUALITY ASSURANCE OPERATIONS
PHARMACEUTICAL PRODUCTS DIV STANDARDS MANUAL
1618 I II 11/24/1970 ABBOTT LABORATORIES QUALITY ASSURANCE OPERATIONS
PHARMACEUTICAL PRODUCTS DIV STANDARDS MANUAL
1620 I II 11/28/1970 NATCON CHEMICAL CO INC NATCOM'S PROCESSING & PACKAGING
FACILITIES & CONTROLS
1622 I II 11/19/1970 DIOSYNTH INC SODIUM HEPARIN
1623 I III 11/25/1970 DOW CHEMICAL CO POLYSTYRENE PRODUCTS, COMPOSITION OF
1624 I III 12/2/1970 UNION CARBIDE CORP BAKELITE, BRAND POLYETHYLENE RESIN
1625 I II 12/7/1970 GENERAL ELECTRIC CO FISSION PRODUCT XENON-133
1626 A III 12/8/1970 BERRY GLOBAL PRODUCTS IN LCFLEX SERIES
1627 A III 12/8/1970 THE SHERWIN-WILLIAMS CO RESIN FORMULATIONS
1629 I II 12/16/1970 FOREST LABORATORIES INC MANUFACTURING SITE,FACILITIES,OPERATING
PROCEDURES, AND PERSONNEL.
1630 I II 12/22/1970 P L BIOCHEMICALS POLYINOSINIC-POLYCYTIDYLIC ACID (STERILE
SOLUTION)
1631 A II 1/5/1971 NATIONAL INSTITUTE DRUG ABUSE MARIJUANA (PRODUCT CODE 1000)
1632 I II 12/22/1970 TENNECO CHEMICALS INC MANUFACTURING AND PACKAGING
1635 I III 1/18/1971 EDWARD MENDELL CO INC EXPLOTAB-PER CORRES 9.23.77 THIS D HAS
BEEN SUPERSEDED BY D-3015
1636 I II 1/27/1971 ABBOTT LABORATORIES ABBOTT LABS QUALITY ASSURANCE
PHARMACEUTICAL PRODUCTS DIV OPERATIONS STANDARDS MANUAL PHARM. DIV.
1638 I III 1/11/1971 COLE POLYMERS LTD BEAD COPOLYMER GRADE DISS-120 MESH
1639 A V 1/5/1971 STERIS CONTRACT STERILIZATION FACILITY IN ELGIN
INDUSTRIAL ESTATE, SWINDON WILTSHIRE,
UNITED KINGDOM
1640 I III 1/15/1971 BAKELITE XYLONITE LTD DFDG 4250 NATURAL LOW DENSITY
POLYETHYLENE
1641 I II 3/4/1971 UNITED STATES DEPT ENERGY GOLD 198 COLLOID (RADIOISOTOPE)
(FORMERLY HELD BY UNION CARBIDE CORP)
Page 44
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1642 I II 12/28/1970 USV PHARMACEUTICAL CORP SUB METHODS, FACILITIES AND CONTROLS
RORER GROUP
1643 I II 1/6/1971 SHAW MUDGE AND CO ALLERDERM INTRUDER M3225
1644 I III 1/26/1971 ALCAN ROLLED PRODUCTS CO ALUMINUM FOIL PACKAGING
1646 A III 12/9/1970 CHEVRON PHILLIPS CHEMICAL CO LP GULF HiD 9414, 9406, 9410 RESIN
1647 I II 2/2/1971 ALUMINUM CO AMERICA PILFERPROOF CLOSURE (28MM)
1649 I II 2/1/1971 GD SEARLE AND CO L-DOPA (OR LEVODOPA) IN BULK ONLY
1650 I III 10/26/1970 LANXESS CORP STYRENE ACRYLONITRILE COPOLYMER
1654 I II 2/18/1971 ABBOTT LABORATORIES GR PROCEDS,CTRLS,FACILS & PACKAGING
PHARMACEUTICAL PRODUCTS DIV P.RICO PLANT
1655 I II 1/28/1971 ORTHO PHARMACEUTICAL CORP ESTRADIOL 17-A-IN PROPYLENE GLYCOL :
PARENTERAL
1656 I III 1/29/1971 HUNTSMAN CHEMICAL CORP POLYSTYRENE PRODUCTS--UNDER TRADE
NAME HOSTYREN (FORMERLY TUF-FLEX)
1658 I IV 3/2/1971 DOW CHEMICAL CO DOWICIL 200 PRESERVATIVE
1659 I II 2/1/1971 CALBIOCHEM BEHRING CORP DL AND L-5-HYDROXYTRYPTOPHAN, 100mg AND
250mg CAPSULE
1660 I II 2/9/1971 THERMOPLASTIC PROCESSES INC POLYVINYL CHLORIDE PLASTIC TUBING
1661 I III 2/16/1971 ALCAN ROLLED PRODUCTS CO C-250 VINYL LACQUER LAMINATED FOIL &
COATED FOIL
1662 A III 3/19/1971 WATSON STANDARD CO LINING FOR ALUMINUM COLLAPSIBLE TUBES
#XB-8298
1663 I II 3/4/1971 UPJOHN CO U-32, 070E (25-HYDROXYCHOLECALCIFEROL)
1664 I II 3/2/1971 ALTANA INC MANUF FACILITIES, PERSONNEL AND MANUF.
CONTROLS
1665 I II 1/15/1971 AMERICAN CHEWING GUM INC MANUF FACILS, PERSONNEL AND CONTROL
INFORMATION
1666 I II 1/15/1971 DOW CORNING CORP PERSONNEL HANDLING NEW DRUG
SUBSTANCES
1667 I II 12/16/1970 SYNTEX USA INC NORANDROSTENDIONE (NAD) --METHODS,
FACILITIES AND CONTROLS
1668 I II 1/22/1971 HERCULES INC HI-FAX A-60 008 NATURAL (HIGH DENSITY
POLYETHYLENE PELLETS)
1669 I II 1/22/1971 HERCULES INC HI-FAX B53-003 NATURAL (HIGH DENSITY
ETHYLENE-BUTENE 1 COPOLYMER)
1670 I V 1/18/1971 ROXANE LABORATORIES INC STERILE VALIDATION DATA FOR COLUMBUS,
OHIO LOCATION
1671 I II 1/19/1971 LINSON LTD DESONIDE
1672 I II 2/5/1971 MONSANTO CO SODIUM TRIMETAPHOSPHATE (NaPO3)3
1673 I II 12/28/1970 GOLDSCHMIDT CHEMICAL DIV WILSON BRONOPOL, A PRESERVATIVE IMPORTED FROM
PHARMA AND CHEMICAL CORP BOOTS PURE DRUG CO.,LTD/ENGLAND
1676 I II 3/5/1971 CALBIOCHEM BEHRING CORP L-TRYPTOPHAN
1677 I I 3/12/1971 DANBURY PHARMACAL INC PERSONNEL,FACILITIES AND CONTROLS
1678 I II 3/15/1971 JWS DELAVAU CO INC DESCRIPTION OF PLANT
1679 I II 11/23/1970 GANES CHEMICALS INC PENNSVILLE ERIODICTYOL BULK
Page 45
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1681 I III 3/26/1971 NATIONAL STARCH AND CHEMICAL CO RESYN 30-1268
1683 A III 3/18/1971 ALBEA AMERICAS INC GLAMINATE® TUBES
1684 I II 4/9/1971 GANES CHEMICALS INC PENNSVILLE MANUFACTURE OF METHAQUALONE &
DIV METHAQUALONE HCL
1686 I III 4/9/1971 COMMONWEALTH PACKAGING CORP CONTRACT PACKAGING OF DRUGS
1687 I III 4/9/1971 NASHUA CORP WP-1 AND RX-1 LABEL ADHESIVES
1688 I II 3/2/1971 GENERAL ELECTRIC CO IODINE-131 AS SODIUM IODIDE IN SODIUM
HYDROXIDE--FISSION PRODUCT
1689 I II 3/2/1971 GENERAL ELECTRIC CO MOLYBDENUM-99 AS AMMONIUM MOLYBDATE IN
AMMONIUM HYDROXIDE-FISSION PROD
1690 I II 3/2/1971 GENERAL ELECTRIC CO MOLYBDENUM-99 AS SODIUM MOLYBDATE IN
SODIUM HYDROXIDE--FISSION PRODUCT
1691 I II 1/22/1971 CALBIOCHEM CORP MANUFACTURING PROCEDURE FOR 5-
AZACYTIDINE
1693 I II 4/20/1971 RT VANDERBILT CO INC VANCIDE FP
1694 I III 12/29/1970 REXENE CORP POLYETHYLENE PE 253
1696 A III 2/26/1971 SK PRIMACOR AMERICAS LLC POLYMER/COPOLYMER FORMULATIONS,
ADHESIVES INCLUDED
1697 I II 3/11/1971 GANES CHEMICALS INC PENNSVILLE SODIUM THIAMYLAL FOR INJ
1698 A III 3/29/1971 EQUISTAR CHEMICALS LP A PRO-FAX NATURAL POLYPROPYLENE
LYONDELLBASELL INDUSTRIES CO MATERIALS
1699 I I 3/26/1971 KEMWORTH LABS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF CUSTOM LYPHILIZATION OF
DRUGS FOR HUMAN USE
1700 I II 3/29/1971 ROBECO CHEMICALS INC SPERMWAX
1701 I III 12/8/1970 ARCO CHEMICAL CO DIV ATLANTIC DYLAN POLYETHYLENE 1020 F-40 RESIN
RICHFIELD CO COMPOUNDS
1702 I II 12/17/1970 INQUIME INDS QUIMECA ESTENE SA PHENYLBUTAZONE USP
1703 I II 12/30/1970 TROPONWERKE GMBH CO KG BUPHENINE HCL (NYLIDRIN)
1704 I II 4/20/1971 PFIZER INC TINIDAZOLE BULK
1707 A III 4/16/1971 TRANSCENDIA INC EXPERIMENTAL FILM PZ-2005.07
1708 I III 4/16/1971 REXHAM CORP RPL-1
1709 I II 4/22/1971 JOHN DICKINSON AND CO LTD POUCHES SUPPLIED TO NORTH HILL PLASTICS,
LTD.
1710 I II 4/23/1971 SSL INTERNATIONAL CHLORHEXIDINE GLUCONATE 20% SOLUTION
1711 I III 4/14/1971 EASTMAN CHEMICAL CO TENITE POLYETHYLENE 1572E-60804, WHITE
1713 I II 4/28/1971 LILLY RESEARCH LABORATORIES DIV INSULIN DRUG SUBSTANCES
ELI LILLY AND CO
1714 I IV 4/30/1970 GIVAUDAN ROURE CORP FLAVORS
1715 I II 5/25/1971 AMCON INDUSTRIES INC AMGLO FILM COATING BASE
1716 I II 5/25/1971 BEECHAM PHARMACEUTICALS UK DIV MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
Page 46
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1717 I IV 8/18/1969 ESSCHEM CO DIV SARTOMER RESINS ETHYLENE GLYCOL DIMETHACRYLATE
INC
1718 I II 5/25/1971 BILCHEM LTD GEN OPER PROCEDS OF WESTERN FHER
LABORATORIES, INC.
1719 I II 5/25/1971 SERVASSEM DIV METAL EDGE INDS FACILITIES & CONTROL USED IN PACKAGING &
LABELS OF DRUGS
1720 I II 5/17/1971 PHYSIOLOGICAL POLYMERS INC P.H.P. POLYMER
1722 I II 5/17/1971 CALBIOCHEM BEHRING CORP INOSINNE (CALBIOCHEM CAT. #800101)
1723 I II 5/18/1971 MERCK SHARP AND DOHME RESEARCH MANUF&CONTROL FACILITIES&PROCEDURES
LABORATORIES DIV MERCK AND CO INC AT SUBSIDIARY PLANT BARCELONETA,PR
Page 49
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1831 I II 12/17/1971 TANABE SEIYAKU CO LTD L - TYROSINE ETHYLESTER
MONOHYDROCHLORIDE
1832 I II 12/17/1971 TANABE SEIYAKU CO LTD DL - METHIONINE
1833 I II 12/17/1971 TANABE SEIYAKU CO LTD L-GLUTAMINE
1834 I II 11/22/1971 HOECHST CELANESE CORP FUROSEMIDE
1835 I II 12/6/1971 TANABE SEIYAKU CO LTD L-LYSINE MONOHYDROCHLORIDE
1836 I III 12/3/1971 REXENE CORP POLYETHYLENE RESIN PE 117
1838 I III 11/24/1971 GUTMANN PLASTICS INC PACKAGING MATERIALS
1839 A II 12/16/1971 COPPERHEAD INVESTMENTS INC SDM-17 (10% NITROGLYCERIN IN LACTOSE)
1840 I IV 11/22/1971 SARTOMER RESINS INC SR 205, TRIETHYLENE GLYCOL
DIMETHACRYLATE
1842 I IV 12/14/1971 ROBECO CHEMICALS INC CETINA
1844 A IV 12/22/1971 PHARMACEUTICAL FLAVOR CLINIC DIV FLAVOR FORMULATIONS
FOOTE AND JENKS
1845 I II 12/28/1971 LETRASET LTD LABEL FOR INCORPORATION IN BLOOD BAG
1846 I II 12/22/1971 ROUSSEL CORP NORETHINDRONE ACETATE
1847 A III 1/4/1972 THE DOW CHEMICAL CO BAKELITE BRAND POLYETHYLENE RESIN
1849 I I 1/7/1972 SIMKINS INDS INC FACILITIES, AND MANUFACTURE PROCEDURES
1850 I III 11/15/1971 DEWEY AND ALMY CHEM DIV WR THERMOPLASTIC COATINGS---TC AMR 12; TC
GRACE AND CO AMR 22; AND TC AMR 44
1851 I II 12/14/1971 UNION CARBIDE CORP TERGITOL MONIONIC SURFACTANT 12-M-10
1853 I II 12/17/1971 SHANKMAN LABORATORIES FACILITIES AND PERSONNEL
1854 I III 1/12/1971 DUPONT DENEMOURS & CO TYVEK SPUNBONDED OLEFIN
1855 I II 1/7/1972 EUTICALS LTD ISOSORBIDE DINITRATE BULK
1857 I II 1/17/1972 PALMER RESEARCH LABORATORIES ISOSORBIDE DINITRATE TRITURATE
1859 I II 1/20/1972 BURTON PARSONS AND CO INC BOILSOAK---BUFFERED NORMAL SALINE
SOLUTION
1860 I II 1/26/1972 CAMBREX PROFARMACO MILANO SRL NITROFURANTOIN ANHYDROUS
1861 I II 1/26/1972 CAMBREX PROFARMACO MILANO SRL NITROFURANTOIN MONOHYDRATE
1862 A II 1/25/1972 SPECGX LLC NALOXONE HCL USP DIHYDRATE
1863 I I 2/4/1972 CINTICHEM INC MANUFACTURING FACILS.-(THIS D FORMERLY
HELD BY UNION CARBIDE CORP)
1864 I II 2/2/1972 CALBIOCHEM BEHRING CORP GAMMA-HYDROXYBUTYRIC ACID SODIUM SALT
1865 I III 1/17/1972 EASTMAN CHEMICAL CO TENITE ACETATE 036E-00969-H2
1867 I II 2/8/1972 PARKE DAVIS AND CO HYDROGEN PEROXIDE SOLUTION 3%
1868 A III 1/28/1972 EASTMAN CHEMICAL CO EASTMAN DOP PLASTICIZER
1869 A II 12/5/1971 TEVA PHARMACEUTICAL INDUSTRIES PROBENECID USP
LTD
1870 A IV 10/20/1971 DOW CHEMICAL CO METHOCEL
1871 I II 2/14/1972 AMERICAN BIO SYNTHETICS CORP METHYLENE CASEIN-ESMA TAB NO. 609
1873 I II 2/23/1972 PARKE DAVIS AND CO METHAQUALONE HYDROCHLORIDE &
METHAQUALONE BASE
1874 I II 2/25/1972 PHARMACHEM CORP EXTRACELLULAR WATER SOLUTION (ECWASOL)
Page 50
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1876 I III 2/24/1972 PACKAGING COORDINATORS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PHILADEPHIA, PA. I
CONVERSION TO III
1877 I II 3/1/1972 DOW CHEMICAL CO POLYTHIOL RESIN
1879 A IV 2/25/1972 SYMRISE INC FLAVORS
1881 I II 3/3/1972 DEXTER CORP V-1243 AND V-1269 COATING MATERIALS.
1882 I II 3/6/1972 GANES CHEMICALS INC PENNSVILLE HEXAFLUORENIUM BROMIDE
1883 I II 3/8/1972 SYNCOR INTERNATIONAL CORP FACILITIES AND SUPERVISORY PERSONNEL
1886 I I 3/7/1972 HASTINGS RADIOCHEMICAL WORKS FACILITIES AND SUPERVISORY PERSONNEL,
DALLAS PLANT
1888 I II 3/8/1972 MEDI PHYSICS INC 99M TC-PERTECHNETATE-SULFUR COLLOID
1889 I II 3/10/1972 UNIV WISCONSIN 1,25-DIHYDROXYCHOLECALCIFEROL
1890 I I 3/8/1972 CIBA GEIGY CORP PERSONNEL
1891 A IV 7/21/1971 DDP SPECIALTY ELECTRONIC DOW CORNING™ MDX4-4159 50% MEDICAL
MATERIALS US 9 LLC GRADE DISPERSION
1892 I II 3/14/1972 PFIZER PHARMACEUTICALS INC DESCRIPTION OF FACILS AND PERSONNEL OF
DEVELOPMENTAL RESEARCH
1893 A III 3/14/1972 BEMIS HEALTHCARE PACKAGING INC PAPER & VINYL ADHESIVE COATING
1895 I II 7/11/1986 GEDEON RICHTER LTD ETHYNODIOL DIACETATE
1898 I II 3/21/1972 BIP CHEMICALS LTD UREA-FORMALDEHYDE MOULDING
1899 I II 3/1/1972 TANABE SEIYAKU CO LTD GLYCINE (AMINOACETIC ACID)
1900 I II 1/5/1971 F RITTER AND CO IMITATION VANILLA CONCENTRATE 20 X #20
1901 I III 2/2/1972 ETHYL CORP ETHYL 8237 POLYVINYL CHLORIDE
1902 I II 3/20/1972 PIERCE AND STEVENS CHEMICAL CORP PROXMELT A-4624
1955 I II 6/19/1972 NAPP CHEMICALS INC PROMETHAZINE HCL (THIS D ORIG HELD BY
VITAMERICAN CORP BY DOLDER LTD
Page 52
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1956 I II 6/23/1972 CONSUPAK INC CONSUPAK BRAND POLYETHYLENE BOTTLES
1959 I II 6/30/1972 EASTMAN KODAK CO N,N- DIMETHYL - P - TOLUIDINE
1960 I III 7/6/1972 NATL PATENT DEVELOPMENT CORP HYDRON TM BIOMEDICAL POLYMER N
1961 I IV 6/30/1972 UNION CARBIDE CORP CELLOSIZE HYDROXYETHYL CELLULOSE
1962 I III 6/20/1972 BASELL USA INC PRO-FAX 6313;6413;6513 NATURAL
POLYPROPYLENE(FORMERLY HELD BY
HERCULES
1963 A III 6/20/1972 EQUISTAR CHEMICALS LP A PRO-FAX 6528 NATURAL POLYPROPYLENE
LYONDELLBASELL INDUSTRIES CO
1965 I II 7/17/1972 DEWEY AND ALMY CHEM DIV WR DAREX EXPERIMENTAL COMPOUND H-1453
GRACE AND CO
1966 I II 7/17/1972 PFIZER INC QUALITY CONTROL INFORMATION FOR NDA
ANTIBIOTIC
1967 I II 2/20/1970 P ROBERTET INC DERMODOR 4775
1968 A III 7/17/1972 TEKNI-PLEX INC FLEXIBLE LAMINATES
1969 I II 7/21/1972 GANES CHEMICALS INC PENNSVILLE PROBENECID
1970 I II 7/24/1972 UPJOHN CO ARA-CYTIDINE 5 - BENZOATE (U - 32,072E)
1971 A III 7/24/1972 WATSON STANDARD CO LACQUER PE-1090-21
1973 I IV 7/27/1972 EASTMAN KODAK CO GLYCOLIDE
1974 I II 8/2/1972 PHENCHEM INDUSTRIES LTD PROMETHAZINE HYDROCHLORIDE
1975 I II 7/1/1972 TITE PAK INC PERSONNEL FACILITIES AND CONTROL
1976 I II 7/24/1972 SANOFI AVENTIS DEUTSCHLAND GMBH D-PROPOXYPHENE HYDROCHLORIDE BULK
1977 I IV 7/28/1972 SCHERER HARTKAPSEL GMBH EMPTY GELATIN CAPSULES (HARD SHELL)
1978 I III 7/10/1972 EQUISTAR CHEMICALS LP SUB NORCHEM'S POLYETHYLENE RESIN NPE-810--
LYONDELLBASELL PRODUCTION & SPECS FOR
1979 I IV 8/4/1972 LILLY RESEARCH LABORATORIES DIV COMPOUND 56997-SWEETENING AGENT
ELI LILLY AND CO (TETRAZOLE)
1980 I II 8/8/1972 LILLY RESEARCH LABORATORIES DIV STERAPS SULFATHIAZOLE 2.5GM, 5GM
ELI LILLY AND CO
1981 I V 8/16/1972 TRAVENOL LABORATORIES INC STERILITY TESTING OF LARGE VOLUME
PARENTERAL SOLUTION
1983 I II 8/10/1972 VERNAY LABORATORIES INC VL201N25 & VL201X22 COMPOUNDS
1984 I II 8/11/1972 MINN 3M LABS LTD ISOETHARINE HCl USP & NUMOTAC TABLETS
WITH ISOETHARINE HCl
1985 A II 8/16/1972 BAYER AG ETHINYL ESTRADIOL
1986 I II 8/25/1972 BURTON PARSONS AND CO INC FLEXSOL CLEANING SOLUTION
1987 I IV 8/25/1972 BURTON PARSONS AND CO INC PREFLEX, NORMAL--FLEXSOL CLEANING &
STORAGE SOLUTION
1988 I II 8/28/1972 SEARLE NORTHINDQONE, MESTRANOL,
MEDROXYPROGESTERONE
1990 I II 9/1/1972 TANABE SEIYAKU CO LTD AMINO ACID MIXTURE
1991 A III 8/7/1972 GLENROY INC PACKAGING FILMS
1992 I II 9/7/1972 SWORDS LABORATORIES LTD FLUPHENAZINE DECANOATE
1993 I II 9/9/1972 TANABE SEIYAKU CO LTD L-GLUTAMIC ACID
Page 53
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
1994 I II 9/18/1972 SHIONOGI AND CO LTD 2A,3A-EPITHIO-5A-ANDROSTAN-17B-OL (10275-S)
EPITIOSTANOL
1997 I II 9/14/1972 GIST-BROCADES NV HYDROCORTISONE BULK
PHARMACEUTICALS
1998 I III 7/31/1972 WEST PHARMACEUTICAL SERVICES INC ACRYLONITRILE RESINS: TYRIL 867 SERIES
Page 57
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
2160 I II 10/10/1973 EDWARD F PRODIGO ENTERPRISES INC FACILITIES, METHODS AND CONTROL FOR
PACKAGING
2162 I II 10/4/1973 HOFFMANN LA ROCHE INC R03-0749/607 DISODIUM PYRIDOXAL
PHOSPHATE INJ
2163 I II 10/4/1973 DELMAR CHEMICALS INC PHENAZOPYRIDINE HYDROCHLORIDE (BULK
POWDER)
2165 I III 10/2/1973 CHEVRON PHILLIPS CHEMICAL CO LP PLASTIC BOTTLES PRODUCED BY AN
INJECTION BLOW MOLDING PROCESS
2166 I II 10/16/1973 PROQUINA SA GENERAL OPERATING PROCEDURE
2167 I II 10/17/1973 HOECHST MARION ROUSSEL INC PROBUCOL (DH-581)
2169 I I 10/24/1973 KYOWA HAKKO USA INC MANUFACTURING FACILITIES & CONTROLS
(BULK DRUGS)
2170 I II 10/24/1973 KYOWA HAKKO KOGYO CO LTD L-ARGININE, L-ARGININE
MONOHYDROCHLORIDE
2171 I II 10/24/1973 PFIZER INC L-LYSINE MONOHYDROCHLORIDE
2172 I II 10/19/1973 BEL MAR LABORATORIES INC STANDARD OPERATING PROCEDURE
2173 I II 10/5/1973 ROBINSON BROTHERS LTD PIPERIDINE HYDROCHLORIDE
2174 I II 10/5/1973 UNION CARBIDE CORP BAKELITE BRAND VINYL CHLORIDE-ACETATE
COPOLYMER, VYNW5 & VYNW 6
2177 I II 10/3/1973 GEORGE ANGUS AND CO LTD COMPOUND KL 1104
2178 I II 10/26/1973 TELEDYNE WIRZ MATERIALS USED/POLYETHYLENE BOTTLES
MADE BY EXTRUSION BLOW MOLD METHOD
2179 I I 10/30/1973 LAFAYETTE PHARMACAL DIV ALCON MANUFACTURING OPERATIONS
LABORATORIES INC
2180 I II 10/15/1973 RHODIA INC FORMULAS: RHODIAL & BOUQUET 5886
2181 I II 1/2/1973 SCHWARZ MANN DIV BECTON PRODUCT 90-1431,90-1432 "SYTHETIC
DICKINSON AND CO SECRETIN"
2182 I V 1/2/1973 TRAVENOL LABORATORIES INC STABILITY & COMPATIBILITY OF DRUG
ADDITIVES INTRO INT INJ
2183 I II 11/12/1973 CELANESE COATINGS CO # 86 GOLD HS CAN LINING
2184 I II 10/9/1973 PFANSTIEHL LABORATORIES INC L-ARGININE MONOHYDROCHLORIDE
2185 I II 10/17/1972 ANTIBIOTICOS SPA HYDROCORTISONE 17-VALERATE
2186 I II 11/15/1973 COMPANHIA INDUSTRIAL PRODUTORA METRONIDAZOLE
DE ANTIBIOTICOS SARL
2188 I II 10/29/1973 COLLETT MARWELL HAUGE A/S PROCAINAMIDE S.R. TAB 300 & 500MGS
2189 I II 11/16/1973 KV PHARMACEUTICAL CO MANUFACTURING FACILITIES AND CONTROLS
2190 I III 11/7/1973 CELANESE PLASTICS CELCON
2192 I II 11/21/1973 ER SQUIBB AND SONS INC PLASTIC CONTAINERS
2193 I II 11/20/1973 SIFAVITOR SRL TRICHLORMETHIAZIDE NF XIII
2194 I II 11/27/1973 SARGENT INDUSTRIES NITRILE COMPOUND SR 3013-70
2195 I II 11/27/1973 ROUSSELL UCLAF HEMATOPORPHYRIN HCL
2196 I II 11/27/1973 INDUSTRIA CHIMICA MILANESE SPA DEXTRO-PROPOXYPHENE HCL
2198 I II 12/3/1973 LILLY RESEARCH LABORATORIES DIV ERTHROMYCIN ESTOLATE
ELI LILLY AND CO
2199 A II 12/7/1973 SIEGFRIED LTD PRIMIDONE
Page 58
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
2200 I II 12/12/1973 SOCIETA ITALIANA MEDICINALI CHLORDIAZE POXIDE & CHLORDIAZE POXIDE
SCANDICCI SIMS SRL (BULK)
2201 I II 12/13/1973 ER SQUIBB AND SONS INC COMPOUND SQ 21, 286
2203 I II 12/21/1973 BRISTOL MYERS SQUIBB CO HALCINONIDE BULK
2204 I II 12/31/1973 ANTIBIOTICOS SPA NON-STERILE BETAMETHASONE (BULK)
2205 I II 12/31/1973 ANTIBIOTICOS SPA DEXAMETHASONE, NON-STERILE (BULK)
2206 I II 12/31/1973 ANTIBIOTICOS SPA TRIAMCINOLONE
2207 I II 12/31/1973 ANTIBIOTICOS SPA TRIAMCINOLONE DIACETATE
2209 I II 1/4/1974 ORGANON INC TUBOCURARINE CHLORIDE
2210 I II 12/19/1973 ALUMINUM CO AMERICA PILFERPROOF CLOSURE (18MM)
2211 I II 1/8/1974 SOLVAY PHARMACEUTICALS QUALITY CONTROL MANUAL
2213 I II 1/16/1974 HOECHST MARION ROUSSEL SA TRIENE
2214 I II 1/22/1974 ICN CANADA LTD PLANT MASTER FILE
2215 I II 1/21/1974 SYNTEX USA INC SODIUM 7-ISOPROPOXYANTHONE-2-
CARBOXYLATE (RS-6818)
2216 I II 1/22/1974 VERNAY LABORATORIES INC STOPPERS
2217 I II 1/23/1974 ORGANICHEM CORP GENERAL DESCRIPTION OF PLANT
2218 I II 1/25/1974 GYMA LABORATORIES AMERICA INC SULFAMETHAZINE
2220 I IV 1/29/1974 KALSEC KALAMAZOO SPICE SPICES AND SPICE EXTRACTIONS
EXTRACTION CO
2221 I II 1/17/1974 PHARMACIA AND UPJOHN ANTIBIOTIC GENERAL INFORMATION
2222 I II 1/17/1974 AYERST LABORATORIES INC DIV QUILENE
AMERICAN HOME PRODUCTS CORP
2223 I I 1/18/1974 GLOGAU AND CO INC MANUFACTURE PROCEDURES
2224 I II 1/28/1974 ADAMHA NIDA METHADONE
2225 I II 2/1/1974 AYERST LABORATORIES INC DIV 6-AM (6-DEOXY-6-AZIDIDIHYDROMORPHINE
AMERICAN HOME PRODUCTS CORP BITARTRATE) AMP.
2226 I II 1/31/1974 EASTMAN KODAK CO 1-CHLORO-2, 4-DINITROBENZENE
2229 A III 2/5/1974 BERRY GLOBAL CLIC-LOC CHILD RESISTANT CLOSURE AND
FINAL GENERATION (FG) CHILD RESISTANT
CLOSURES
2230 I II 2/4/1974 ANDRE GUERBET LABORATORIES IOCARMIC ACID
2231 I II 8/17/1973 KV PHARMACEUTICAL CO PSEUDOEPHEDRINE HCL &
CHLORPHENIRAMINE MALEATE S.R.C.
2232 I II 2/20/1974 FIRMENICH INC CHEMODERM 840 & 985
2234 I II 2/20/1974 SCHWARZ MANN DIV BECTON BRADYKININ POTENTIATING FACTOR-
DICKINSON AND CO NONAPEPTIDE
2235 I II 2/26/1974 PECHET MAURIC M MD 1A-HYDROXY VITAMIN D3
2236 I II 2/27/1974 KV PHARMACEUTICAL CO FACILITIES, CONTROL, PERSONNEL
2237 A III 3/1/1974 AMCOR FLEXIBLES SHELBYVILLE PACKAGING LAMINATES
2238 I II 3/1/1974 BOFORS INDS ISOSORBIDE DINITRATE
2239 A II 3/1/1974 CAMBREX CHARLES CITY INC SULFASALAZINE USP
2240 I II 12/14/1973 CYCLO PRODUCTS INC N-DECYLMETHYL SULFOXIDE
2241 I II 2/26/1974 P L BIOCHEMICALS POLYADENYLIC ACID
2242 I II 2/26/1974 P L BIOCHEMICALS POLYURIDYLIC ACID
Page 59
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
2245 I II 3/4/1974 DOW CORNING CORP DOW CORNING X-95704 ANTIMICROBIAL
2246 I II 3/5/1974 BEECHAM-MASSENGILL PHARMS DIV 6-AMINO PENICILLANIC ACID
BEECHAM INC
2247 I II 3/12/1974 KYOWA HAKKO KOGYO CO LTD L-TRYPTOPHAN, L-TYROSINE, L-ASPARTIC ACID
(L-PROLINE, L-GLUTAMIC)
2248 A II 3/21/1974 CAMBREX PROFARMACO MILANO SRL BISACODYL
2249 I III 3/22/1974 MYLAN TECHNOLOGIES INC PLASTIC BOTTLES
2250 I I 3/28/1974 CARTRIX PARENTERAL SYSTEMS MANUFACTURE OF PARENTERAL PRODUCTS
(FACILITIES, CONTROLS PERSONNEL)
2251 I II 3/18/1974 ORGANON INC NORANDROS TENEDIONE (NANDROLONE)
2253 I II 3/28/1974 RP SCHERER CORP DIGOXIN CAPS
2254 I II 3/27/1974 RHONE POULENC LTD FACILITIES, PERSONNEL & PROCEDURES FOR
PHARMACEUTICAL FINISHED PRODUCT
PRODUCTION IN DAGENHAM, ENGLAND.
2255 I II 3/14/1974 DOW CHEMICAL CO PZ 5561.21 (DURAFILM PRODUCT)
2256 A III 4/2/1974 BERRY GLOBAL INJECTION MOLDED CLOSURES
2257 I II 4/8/1974 PFW INC MENTHYL ANTHRANILATE 263610,260160
2258 I II 4/9/1974 FERMENTA FRANCE SA HYDROXYUREA BY OLMACO OF
EMPERNON,FRANCE (FORMERLY HELD BY
OLMACO)
2259 I II 4/11/1974 SQUIBB HYDROXYUREA
2260 I II 4/7/1974 MARVI SA MANUFACTURE OF GLASS AMPULS, VIALS
2261 I I 4/10/1974 CALBIOCHEM BEHRING CORP STERILE MANUFACTURING FACILITY FOR
ONCOLOGICAL PRODUCTS
2262 I II 3/28/1974 LABORATORIO ELEA SACIFYA HUMAN CHORIONIC GONADOTROPHIN
2263 I II 4/24/1974 SYNTEX USA INC RS 8584
2264 I III 4/17/1974 BASF CORP POLYSTYRENE PLASTICS
2265 I II 4/25/1974 AYERST LABORATORIES INC DEXPROPRANOLOL INJ
2266 I I 4/19/1974 ISOMEDIX INC RADIATION PROCESSING OF DRUGS
2268 I II 4/30/1974 SOLVAY PHARMACEUTICALS CHENODEOXYCHOLIC ACID
2269 I V 4/26/1974 STERIS ISOMEDIX SERVICES CONTRACT STERILIZATION FACILITY IN
MORTON GROVE,IL
2270 I II 4/30/1974 H REISMAN CORP CHLORPROMAZINE HYDROCHLORIDE (BULK)
2271 I III 5/1/1974 ABBOTT LABORATORIES SEMI-RIGID CONTAINER PLASTIC BOTTLE
PHARMACEUTICAL PRODUCTS DIV
2273 I II 5/10/1974 CELLO FOIL PRODUCTS INC STRUCTURED PACKAGING MATERIALS
2274 I II 5/8/1974 WILLIAM FREEMAN AND CO LTD RUBBER COMPOUND 161063
2275 I III 5/2/1974 IMCO CONTAINER CO CONTAINERS, CLOSURES AND FITMENTS
2276 I II 5/15/1974 DELMAR CHEMICALS INC KETAZOLAM, BULK POWDER
2277 I II 5/17/1974 ROCHE DIAGNOSTICS GMBH DIGOXIN PRODUCTS
2278 I II 5/23/1974 KV PHARMACEUTICAL CO CHLORPHENIRAMINE MALEATE 12 MG SRC
2279 I II 5/23/1974 NAPP CHEMICALS INC MEGLUMINE SALICYLATE
2280 I II 5/31/1974 DELMAR CHEMICALS INC D.M.M.P.(1,3-BISMETHOXYMETHYL-5-ETHYL-5-
PHENYL-BARBITURIC ACID)BULK
2281 I II 5/31/1974 UNION CARBIDE CORP ZIRCONIA TEXTILES
Page 60
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
2282 I II 5/30/1974 PCR INC PROMAZINE HYDROCHLORIDE
2284 I III 6/3/1974 SHEFFIELD TUBE CORP TUBE LINERS, TUBE CLOSURE SEALANTS AND
CAP LINERS
2286 I II 6/11/1974 CAMBRIDGE NUCLEAR RADIOPHARM SODIUM CHLORIDE NA-24
CORP
2287 I II 6/12/1974 ARMOUR PHARMACEUTICAL CO DIPALMITOYL-DL-3-LECITHIN
2288 I III 6/14/1974 AMERICAN NATIONAL CAN CO ALUMINUM FOIL-POLYPROPYLENE LAMINATE
2289 I II 6/12/1984 UNION CARBIDE CORP SYNTHETIC SODIUM ALUMINOSILICATE
ABSORBENTS (MOLECULAR SIEVES)
2291 I II 6/18/1974 ROUSSEL CORP ESTRADIOL BENZOATE
2292 I II 6/19/1974 HOFFMANN LA ROCHE INC PROCARBAZINE HYDROCHLORIDE
PARENTERAL
2293 I II 6/21/1974 GANES CHEMICALS INC PENNSVILLE GLUTETHIMIDE BULK
2294 I II 6/24/1974 ETHYL CORP TOLMETIN (MCN2559-21-98)
2295 I III 5/30/1974 REEVES BROTHERS INC COMPOUND #5165 RUBBER GASKET MATERIAL
2296 I II 8/23/1973 EMSON RESEARCH INC DISPENSING DEVICES
2297 A IV 6/14/1974 ASHLAND LLC POLYVINYLPOLYPYRROLIDONE
(CROSPOVIDONE)
2298 I II 7/1/1974 KNOLL AG CHEMISCHE FABRIKEN DIHYDROXYPROPYL-THEOPHYLLIN
2299 I II 7/3/1974 KYOWA HAKKO KOGYO CO LTD FACILITIES & CONTROLS (UBE PLANT IN JAPAN)
2300 I II 7/5/1974 BEECHAM PHARMACEUTICALS PTE LTD GENERAL OPERATING PROCEDURES
SINGAPORE PLANT
2301 I II 7/11/1974 INDUSTRIAL REACTOR LABORATORIES RADIOCHEMICAL 99 MOO 3
INC
2302 I II 7/11/1974 GANES CHEMICALS INC PENNSVILLE DIPYRONE
2303 A II 7/11/1974 OLON SPA DICYCLOMINE HYDROCHLORIDE
2304 I II 7/16/1974 KYOWA HAKKO USA INC L-VALINE, L-THREONINE, L-GLUTAMINE
2305 I III 7/17/1974 NATIONAL STARCH AND CHEMICAL CO ADHESIVES E 56620 & 56635
2306 I V 1/16/1974 SSL INTERNATIONAL TOXICOLOGY STUDIES ON CHLORHEXIDINE
GLUCONATE
2308 I II 7/30/1974 BRACCO IND CHIMICA SPA DIATRIZOIC ACID
2309 I II 3/15/1974 FERRING AB DESURIN, MINRIN, DDAVP
2310 I II 7/30/1974 KV PHARMACEUTICAL CO METHYLTESTOSTERONE
2311 I II 8/6/1974 TRAVENOL LABORATORIES INC PROTEIN HYDROLYSATE BULK POWDER FOR
PARENTERAL SOLUTIONS
2312 I II 8/8/1974 SYNTEX PUERTO RICO INC FACILITIES AND CONTROLS
2313 I II 8/6/1974 PFIZER LABORATORIES DIV PFIZER INC ANTIBIOTIC SUSCEPTIBILITY DISCS
2314 I II 8/8/1974 BOEHRINGER INGELHEIM CHEMICALS AMPHETAMINE BULK AND DEXTRO
INC DESOXYEPHEDRINE
2315 A V 7/26/1974 BEN VENUE LABORATORIES INC STERILE PROCESSING FACILITY IN BEDFORD,
OHIO
2316 I II 8/16/1974 MALLINCKRODT INC MANUFACTURING FACILITY AT RALEIGH, NORTH
CAROLINA
2317 I I 8/19/1984 USV PHARMACEUTICAL CORP SUB MANUFACTURE, PACKAGING AND
RORER GROUP DISTRIBUTION
Page 61
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
2318 I II 8/23/1974 TAKEDA PHARMACEUTICAL CO LTD FOLIC ACID
2320 I II 8/27/1974 SWORDS LABORATORIES LTD FLUPHENAZINE ENANTHATE N.F.
2321 I II 8/26/1974 GANES CHEMICALS INC PENNSVILLE PROPANTHELINE BROMIDE
2324 I II 9/6/1974 BURTON PARSONS AND CO INC BURTON PARSONS BUTTON FOR HYDROPILIC
SOFT CONTACT LENSES
2325 I II 9/10/1974 OHIO MEDICAL PRODUCTS DIV AIRCO ETHRANE (ENFLURANE) FORANE (ISOFLURANE)
INC
2326 I III 8/21/1974 FLINT HILLS RESOURCES LP POLYETHYLENE RESINS
2327 I II 9/18/1974 GAF CORP CHEMICAL DIV FLUOROL 7GA
2328 I V 9/20/1974 TRAVENOL LABORATORIES INC LARGE VOLUME PARENTERAL PRODUCTS -
PYROGEN TESTING
2329 I III 9/26/1974 HOECHST CELANESE CORP PACKAGING
2331 I II 10/7/1974 WIMMER KG RUBBER STOPPERS A-40 GREY FOR INFUSION
BOTTLES
2332 I II 10/10/1974 MERRELL-NATIONAL LABORATORIES FACILITIES AND CONTROLS
INC
2333 I II 10/9/1974 UPJOHN CO PELLETHANE MDI BASED URETHANE
ELASTOMER
2335 I IV 10/16/1974 BARNES-HIND PHARMACEUTICALS INC BARNES-HIND BOILING SOLUTION
2336 I II 10/24/1974 ALCON LABORATORIES INC STEROID/ANTI-INFECTIVE
OPHTH.COMBINATIONS;SAFETY/EFFICACY
ANALYSIS
2337 I III 10/7/1974 REXENE CORP POLYPROPYLENE PLASTICS 14B AND 14S
SERIES
2338 I III 10/3/1973 GLYCO CHEMICALS INC ACRAWAX C
2341 I II 9/4/1974 DEWEY AND ALMY CHEM DIV WR DAREX CAP COMPOUND 64
GRACE AND CO
2342 I II 10/17/1974 SIGMA F AND D DIV LTD L-TRYPTOPHAN
2343 A III 10/28/1974 INEOS BAREX USA LLC BAREX 210 RESIN
2344 I II 10/17/1974 KV PHARMACEUTICAL CO LEVODOPA S.R.C. 300MG
2345 I II 10/29/1974 DOW CORNING CORP DOW CORNING F-218 FLUID
2346 I II 10/24/1974 BURTON PARSONS AND CO INC SOACLENS (SILICO) CONTACT LENS SOLUTION
2347 I II 10/31/1974 BARNES-HIND PHARMACEUTICALS INC SOFT CONTACT LENS CLEANER FOR USE WITH
FLEXLENS (TRANSF. TO DEVICES)
2348 I II 11/1/1974 HOECHST AG HALOTHANE
2349 I I 11/4/1974 DENVER CHEMICAL MANUFACTURING MANUFACTURING FACILITIES AND CONTROLS
CO
2350 I II 9/17/1974 UNITED STATES DEPT ENERGY RADIOISOTOPE MOLYBDENUM-99-P-7
(FORMERLY HELD BY UNION CARBIDE CORP)
2352 I II 11/12/1974 PIERCE AND STEVENS CHEMICAL CORP FOAMCOAT (TM) A7673A
Page 62
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
2356 I II 11/6/1974 WAITAKI INTERNATIONAL BIOSCIENCES CHENODEOXYCHOLIC ACID
SUB WAITAKI CANADA LTD
2358 I II 11/18/1974 WARNER LAMBERT CO LLC PLEXIGEL (POLYETHYLENE OINT. BASE)
2359 I II 11/19/1974 SCIENTIFIC ASSOC INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
2360 I III 11/25/1974 UNION CARBIDE CORP UDEL POLYSULFONE RESIN P-1700
2361 I II 11/29/1974 ABBOTT LABORATORIES QUALITY ASSURANCE OPERATION STANDARDS
PHARMACEUTICAL PRODUCTS DIV
2363 I II 11/27/1974 RENASA, INC. SUBSIDIARY OF E.R. HALOG CREAM
SQUIBB
2364 I II 11/26/1974 SANOFI CHIMIE NORGESTERAL ACETATE OXIME
2365 I II 12/20/1974 MERCK FROSST CANADA INC TECHNETIUM Tc 99M POLYPHOSPHATE KIT
2366 I II 12/6/1974 WACKER CHEMIE GMBH SILICONE RUBBER HL 44
2367 I III 12/6/1975 HB FULLER CO FULLER'S HM-777-R INNER SEAL
2368 A II 12/10/1974 TRIFARMA SPA PROCHLORPERAZINE MALEATE
2370 I II 12/3/1974 FLOW PHARMACEUTICALS INC PLIACIDE
2371 I II 12/12/1974 STUDSVIK ISOTOPSERVICE AB RADIOA XENON-133 GAS
2372 I II 12/16/1974 EI DUPONT DE NEMOURS AND CO INC SODIUM-24 RADIOISOTOPE (FORMERLY NEW
ENGLAND NUCLEAR)
2373 I II 12/13/1974 HOFFMANN LA ROCHE INC 1a,25-DIHYDROXYCHOLECALCIFEROL
(RO21,5535) IN USAN IS CALCITRIOL
2374 I II 12/18/1974 ER SQUIBB AND SONS INC FLUPHENAZINE DECANOATE INJ.
2376 I II 12/18/1974 ANTIBIOTICOS SPA PREDNISOLONE SODIUM PHOSPHATE BULK
2377 I II 12/18/1974 ANTIBIOTICOS SPA BETAMETHASONE SODIUM PHOSPHATE, N.F. XIII
BULK
2378 I II 12/18/1974 ANTIBIOTICOS SPA DEXAMETHASONE SODIUM PHOSPHATE BULK
2380 I II 12/20/1974 ALLERGAN PHARMACEUTICAL GSH-1157-2333X PROLASE 300 (SOFT CONTACT
LENS CLEANER)
2381 I II 12/6/1974 PFANSTIEHL LABORATORIES INC a LACTULOSE
2382 I I 12/31/1974 EI DUPONT DE NEMOURS AND CO INC MANUFACTURING FACILITIES AND CONTROL
2383 I I 12/31/1974 EI DUPONT DE NEMOURS AND CO INC MANUFACTURING FACILITIES AND CONTROLS
(FORMERLY NEW ENGLAND NUCLEAR)
2384 I II 1/3/1975 SIGMA F AND D DIV LTD 2-DEOXY-D-GLUCOSE
2385 I II 1/3/1975 CIECH POLFA SULFAMERAZINE
2386 I II 1/3/1975 CIECH POLFA SULFAMETHAZINE
2387 I II 1/3/1975 CIECH POLFA SULFATHIAZOLE
2388 I V 1/7/1975 STERIGENICS INTERNATIONAL INC STERILE FINISHED PRODUCTS AND STERILE
PROCESSING OPERATIONS LOCATED IN
ROCKAWAY, NJ
2389 I II 1/10/1975 LILLY RESEARCH LABORATORIES DIV PRODUCTION OPERATIONS
ELI LILLY AND CO
2390 I II 1/14/1975 ER SQUIBB AND SONS INC PERSONNEL FOR PUERTO RICO PLANTS
2391 I I 1/17/1975 SYNTEX RES DIV SYNTEX LABS INC METHODS, FACILITIES AND CONTROLS
Page 63
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
2392 A III 1/16/1975 EQUISTAR CHEMICALS LP A PROFAX ® PD 191 NATURAL POLYPROPYLENE
LYONDELLBASELL INDUSTRIES CO RESINS
2394 I III 2/17/1975 GENERAL ELECTRIC CORP VALOX DR-140 GRADE RESIN
2395 I II 1/29/1975 DELMAR CHEMICALS LTD CHLORDIAZEPOXIDE HYDROCHLORIDE
2396 I II 2/7/1975 LEHIGH PACKAGING GENERAL INFO., BURLINGTON PLANT NEW
JERSEY
2397 I II 2/7/1975 SYNTEX USA INC 7-METHYLSULFINYLXANTHONE-2-CARBOXYLIC
ACID (RS-7337)
2399 I II 2/11/1975 ROUSSELL UCLAF 19-NOR-ANDROSTENEDIONE (NANDROLONE)
2400 I II 2/19/1975 SYNTEX USA INC INHALER DEVICE
2401 I III 2/19/1975 DUPONT TEIJIN FILMS US LP CONSOLIDATED INTO D 7760
2402 I II 2/21/1975 WINTHROP PHARMACEUTICALS DIV ENTRENOL
STERLING DRUG INC
2403 I II 2/26/1975 ER SQUIBB AND SONS INC DIATRIZOIC ACID
2404 I II 2/26/1975 TAYLOR PHARMACAL CO DYMASIL BRAND DIMETHICONE 350
2406 A III 2/19/1975 INEOS STYROLUTION GROUP GMBH K-RESIN SBC
2407 I III 2/20/1975 FLINT HILLS RESOURCES LP POLYETHYLENE RESIN PE 143, 207, AND 178
2408 I II 2/26/1975 PARKE DAVIS AND CO MINOCYCLINE HYDROCHLORIDE CAP
2409 I II 1/21/1975 KV PHARMACEUTICAL CO ANTIPRESS TAB
2410 I II 2/25/1975 BOEHRINGER MANNHEIM GMBH DOXEPIN
2411 I II 3/5/1975 COLUMBIA RESEARCH CORP IRRADIATION STERILIZATION PROCEDURE
2413 I II 3/10/1975 KV PHARMACEUTICAL CO AMITRIPTYLINE HYDROCHLORIDE
2414 I II 3/10/1975 BARNES-HIND PHARMACEUTICALS INC SOFT LENS COORT DROPS--SOFT LENS
HYDRATING SOLUTION(TRANS TO DEVICE)
2416 I II 3/12/1975 CONCORD LABORATORIES INC MANUFACTURING & QUALITY ASSURANCE
PROCEDURE
2417 A III 1/13/1975 SELIG SEALING PRODUCTS INC CAPSEAL BRAND SA-66 CLOSURE LINER &
CAPSEAL BRAND SA-22 CLOSURE LINER
2418 A II 2/24/1975 PHARMACIA AND UPJOHN CO LLC GLIPIZIDE USP
WHOLLY OWNED SUB OF PFIZER INC
2419 I II 3/28/1975 KERR MANUFACTURING CO TITANIUM TETRAFLOURIDE SOLUTION
(MOUTHWASH)
2420 A II 3/11/1975 STARKS ASSOC INC LOMUSTINE (CCNU) BULK
2421 A II 3/14/1975 SUMITOMO CHEMICAL CO LTD HYDRALAZINE HYDROCHLORIDE
2423 I II 3/27/1975 NAPP CHEMICALS INC PHENYLBUTAZONE
2425 I II 3/27/1975 ROUSSELL UCLAF ETHINYL ESTRADIOL
2426 I II 3/28/1975 LILLY RESEARCH LABORATORIES DIV PAPAVERINE HYDROCHLORIDE
ELI LILLY AND CO
2427 I II 3/19/1975 HEINRICH MACK NACHF TRIFLUOROTHYMIDINE
2428 I II 3/13/1975 SIGMA F AND D DIV LTD SODIUM PARA-AMINOBENZOATE
2430 I II 4/4/1975 ANALYTICA CORP CHLOROTRIANISENE
2431 I III 3/11/1975 MONSANTO CO PLASTIC CLOSURES AND FITMENTS MADE BY
AN INJECTION MOLDING PROCESS
2433 I III 4/8/1975 LUDLOW SPECIALTY PAPERS HEAT SEAL LABEL PAPER
2434 A III 3/14/1975 TEKNI-PLEX INC TRI-SEAL CLOSURE LINER MATERIALS
Page 64
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
2435 A II 3/13/1975 AESICA PHARMACEUTICALS LTD FLURBIPROFEN AND SODIUM FLUBIPROFEN
2436 I IV 4/8/1975 ICI AMERICAS INC ARLAMOL E (PPG-15 STEARYL ETHER)
2437 I II 4/9/1975 RHODIA INC RUBIDAZONE HYDROCHLORIDE RP 22, 050
2438 A II 4/21/1975 PRIME EUROPEAN THERAPEUTICALS CHLORTHALIDONE USP-EP
SPA (EUTICALS SPA)
2439 I II 4/8/1975 RHODIA INC TETRAMISOLE HYDROCHLORIDE,
LEVOROTATORY
2440 I II 3/25/1975 SYNTEX LABS HEPARIN, SODIUM
2441 I II 4/30/1975 MALLINCKRODT INC GALLIUM CHLORIDE (GA-67)
2442 I II 4/21/1975 LILLY RESEARCH LABORATORIES DIV ERGONOVINE MALEATE 0.2MG
ELI LILLY AND CO
2443 I II 4/2/1975 MOLECULAR DESIGN INC BAROPHANE (LAMINATED PLASTIC SHEET)
2444 I II 4/30/1975 TAYLOR PHARMACAL CO TEMPORARY FILLING FACILITIES
2446 I II 5/7/1975 NOVO LABORATORIES LTD SULPHATED INSULIN
2447 I I 4/14/1975 YAMAKAWA CHEMICAL INDUSTRY CO ASEPTIC PENICILLIN FACILITY AS
LTD MANUFACTURED IN SERMONETA (LATINA), ITALY
Page 66
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
2515 I II 8/25/1975 ABBOTT LABORATORIES I-125-FIBRINOGEN (HUMAN) SENSOR
PHARMACEUTICAL PRODUCTS DIV
2516 A II 8/28/1975 NOVUS FINE CHEMICALS LLC PSEUDOEPHEDRINE HCL, SULFATE, AND BASE
BULK POWDER
2517 A III 8/27/1975 FLINT HILLS RESOURCES LP 23M2A AND 23M2Acs038
2518 A III 9/4/1975 TRI-SEAL LLC A TEKNI-PLEX CO CAP LINER MATERIALS
2519 I II 9/19/1975 BARNES-HIND PHARMACEUTICALS INC CONTACT LENS CLEANER USED W/BRUCKNER
TENITE BUTYRATE LENS(TRANS DEVCS)
2522 I II 9/18/1975 SEAL BAG CO INC SURGI-PEEL POUCHES
2523 I II 6/23/1975 SIGMA F AND D DIV LTD AMINO ACIDS: L-ARGININE, FREE BASE AND L-
ARGININE, HYDROCHLORIDE
2524 I III 9/4/1974 NOVA CHEMICALS USA INCORPORATED POLYSTYRENE RESINS
2525 I V 8/22/1975 KALI QUALIF OF PROFESSIONAL STAFF--(D
FORMERLY HELD BY MID-WEST MEDICAL)
2526 I II 8/3/1975 EI DUPONT DE NEMOURS AND CO INC COPPER-64 (NITRATE & CHLORIDE)
2527 I II 9/24/1975 NAPP CHEMICALS INC CHLOROTHIAZIDE
2528 I II 9/17/1975 PFC ITALIANA SRL DIV ALFA CHEMICALS THIORIDAZINE HCL
ITALIANA
2529 I II 9/15/1975 HOECHST AG PROCAINE HCL--METHODS, FACILS, CONTROLS
USED IN
2531 I II 9/12/1975 MALLINCKRODT INC LENPERONE 4'-FLUORO-4-[4-(p-FLUORO-
BENZOYL)-PIPERDINO] BUTYROPHENONE
2532 I II 10/8/1975 APOTEKSVARUCENTRALEN VITRUM AB BRANCHED-CHAIN AMINO ACID SOLU
2533 I II 9/25/1975 LILLY RESEARCH LABORATORIES DIV TYRAMINE HCL INJ
ELI LILLY AND CO
2534 I II 10/13/1975 DINAMITE DIPHARMA SPA ALLOPURINOL
2535 I II 10/6/1975 INDUSTRIA CHIMICA MILANESE SPA AMITRYPTILINE HCL
2536 I II 7/23/1975 GARDENA RUBBER CO INC COMPOUND GRC 604-70
2537 I II 10/21/1975 CILAG CHEMIE AG TOLMETIN SODIUM DIHYDRATE
2539 I II 10/23/1975 BARNES-HIND PHARMACEUTICALS INC SOFT CONTACT LENS CLEANER
2540 I III 10/23/1975 FLOW PHARMACEUTICALS INC PORTA-FLOW DEVICE(HYDROPHILIC LENS
STORAGE AND DISINFECTION)
2541 I IV 10/3/1975 FOREST LABORATORIES INC SYNCHRON ORAL-CARRIER
2542 I II 10/22/1975 PFANSTIEHL LABORATORIES INC MALTOSE MONOHYDRATE
2543 I III 10/28/1975 LLOYD MANUFACTURING CO INC 14-B WHITE RUBBER LINING MATERIAL
2544 I II 10/31/1975 CONVERTERS INK CO INK FORMULATIONS
2545 I II 11/6/1975 COMMOMWEALTH SERUM LABS INSULIN SALT CAKE & INSULIN CRYSTALS
2546 I III 11/6/1975 CONTINENTAL CAN COMPANY IRRIGATION BOTTLES
2547 I II 10/31/1975 MEDIMPEX NORTHAMERICA INC PHENYLBUTAZONE
2548 I II 10/31/1975 MEDIMPEX NORTHAMERICA INC DIHYDROERGOTOXIN METHANESULPHONATE
2549 I III 11/4/1975 GENERAL ELECTRIC CO RADIOISOTOPES
2550 I III 11/12/1975 BURTON PARSONS AND CO INC FLEXSOL 43 PLASTIC BUTTON
2551 I II 11/3/1975 RESEARCH INDUSTRIES CORP DIMETHYL SULFOXIDE (DMSO)
2552 I I 11/14/1975 JT BAKER CHEMICAL CO MASTER FACILITIES
2553 I III 3/8/1976 PRINTPAK INC COMPOSITE CONSTRUCTION LAYER FILMS
Page 67
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
2554 I I 11/4/1975 INTERNATIONAL NUTRONICS INC FACILITY DESCRIPTION & PERSONNEL (THIS D
FORMERLY HELD BY RSA CORP)
2557 I II 11/7/1975 HAFSLUND NYCOMED PHARMA AG HEXOPRENALINE SULFATE
2558 I IV 11/12/1975 BURTON PARSONS AND CO INC ADAPETTES, (LUBRICATING SOLUTION)
2559 I III 11/21/1975 BURTON PARSONS AND CO INC FLEXSOL 55 PLASTIC BUTTON
2560 I III 11/21/1975 BURTON PARSONS AND CO INC FLEXSOL 72 PLASTIC BUTTON
2561 I II 8/30/1975 KV PHARMACEUTICAL CO ACETAZOLAMIDE 500MG SRC
2562 I II 11/13/1975 PHARMA-WALDHOF GMBH GLUTATHIONE, OXIDIZED HYDRATE
2563 I I 11/21/1975 SYNTEX USA INC MANUFACTURING FACILITIES AND CONTROLS
(NASAL+-SUFFLATOR SYSTEM)
2564 I II 11/20/1975 SANWA CHEMICAL CO LTD CYCLANDELATE
2565 A II 11/12/1975 TEVA PHARMACEUTICAL INDUSTRIES FUROSEMIDE USP
LTD
2566 I II 11/25/1975 GANES CHEMICALS INC PENNSVILLE DIETHYLPROPION HYDROCHLORIDE
2567 I II 12/1/1975 KORO CORP KORACRYL THERMOPLASTIC SHEETING
2568 I II 12/5/1975 SYNTEX USA INC TRALONIDE
2569 I II 11/21/1975 SIGMA F AND D DIV LTD TAURINE
2570 I II 7/21/1975 SIGMA F AND D DIV LTD D-PHENYLALANINE
2572 I II 11/13/1975 EMERY IND INC SPECS & COMPOSITION EMERSOL 315-LINLEIC
ACID
2573 I II 12/3/1975 PFEIFER AND LANGEN MANUFACTURING AND DESCRIPTION
(DEXTRAN)
2574 I I 12/10/1975 OTSUKA PHARMACEUTICAL CO LTD MANUFACTURING FACILITIES AND SPECS--
MALTOSE SUGAR
2576 I I 12/16/1975 MK LABORATORIES INC PLANT FACILITIES AND CONTROLS
2577 I I 12/22/1975 TECHNICAL WAREHOUSE SERVICES INC MANUFACTURING FACILITIES AND CONTROLS
Page 69
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
2629 I III 3/18/1976 STEVENS ELASTOMERIC AND PLASTIC MX-1834 E.P.D.M. I.V. STOPPER FORMULATION
PRODUCTS SUB JP STEVENS AND CO
INC
2630 I II 2/19/1976 CYCLO PRODUCTS INC TRIPROLIDINE HCL (THIS D FORMERLY HELD BY
TRAVENOL LABS, INC)
2631 I II 3/18/1976 KYOWA HAKKO KOGYO CO LTD AMINO ACIDS
2633 I II 3/1/1976 INDUSTRIE CHIMICHE FARMACEUTICHE INDOMETHACIN
ITALIANE SPA
2634 I IV 3/12/1976 EASTMAN CHEMICAL CO TENITE BUTYRATE (FOR CONTACT LENS)
2636 I V 3/25/1976 BELL MORE LABS INC FILLING & FREEZE DRYING METHODS FOR IN-
VIVO MATERIAL
2639 I II 3/8/1976 CENTERCHEM INC SODIUM HEPARIN
2640 I II 3/18/1976 ROUSSELL UCLAF DELTA-5 (10)-NORANDROSTENEDIONE
2641 I II 3/25/1976 SYNTEX USA INC CLOPREDNOL
2643 I II 3/23/1976 BARNES-HIND PHARMACEUTICALS INC B-H SOFT LENS RINSING AND BOILING
SOLUTION-HYDROCURVE(TRANS-DEVICES)
2646 I I 3/30/1976 SCHERING CORP SUB SCHERING MANUFACTURING PROCEDURES
PLOUGH CORP
2647 I II 4/7/1976 LILLY RESEARCH LABORATORIES DIV EPHEDRINE SULFATE
ELI LILLY AND CO
2648 I II 4/8/1976 MONSANTO CO HEXAMETHYLENE DIAMINETETRA ACID
(METHYLENE PHOSPHONIC)
2649 I II 4/2/1976 SOLMAG SPA FUROSEMIDE
2651 I II 4/26/1976 ANTIBIOTICOS SPA TRIAMCINOLONE ACETONIDE
2652 I II 4/6/1976 AZIENDE CHIMICHE RIUNITE ANGELINI FACILITIES IN APRILIA, ITALY
FRANCESCO SPA
2653 I II 4/19/1976 MALLINCKRODT INC SELENOMETHIONINE
2654 I III 4/22/1976 BORDEN CHEMICAL CO PVC HOMOPOLYMER RESINS
2655 I II 4/1/1976 PIERREL SPA TRIAMCINOLONE ACETONIDE
2656 I II 4/1/1976 PIERREL SPA TRIAMCINOLONE ALCOHOL
2657 I II 4/26/1976 ANTIBIOTICOS SPA SPIRONOLACTONE
2658 I II 4/22/1976 MERCK SHARP AND DOHME RESEARCH MANUFACTURE AND CONTROL
LABORATORIES DIV MERCK AND CO INC
Page 72
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
2733 I III 8/20/1976 CELANESE PLASTICS CELGARD MICROPOROUS FILM AND HOOLOW
FIBER PRODUCTS
2734 I II 9/2/1976 BECKMAN INSTRUMENTS INC DIV SYNTHETIC BOVINE PARATHYROID HORMONE
SMITHKLINE BECKMAN CORP (1-34) PEPTIDE
2735 I II 8/10/1976 ROUSSEL CORP HEMATOPORPHYRIN BASE
2736 A II 7/19/1976 SANOFI CHIMIE DEXAMETHASONE ACETATE ANHYDROUS USP
2737 I II 7/19/1976 ROUSSEL CORP DEXAMETHASONE SODIUM
METASULFOBENZOATE
2738 A II 8/2/1976 OLON SPA DIETHYLPROPION HCL
2739 I II 8/30/1976 PLIVA HRVATSKA DOO SULFISOXAZOLE
2740 I II 9/3/1976 ER SQUIBB AND SONS INC KENALOG LOTION
2741 I II 9/3/1976 ER SQUIBB AND SONS INC TRIAMCINOLONE ACETONIDE CONCENTRATE
2742 I II 9/1/1976 ROCHE PRODUCTS INC L
2743 I III 8/23/1976 ONYX CHEM CO DIV MILLMASTER ONYX MAPROLYTE XL AND LX
CORP
2744 I II 9/9/1976 PHARM ECO LABORATORIES INC FACILITIES FOR PHARM-ECO LABS
2745 I II 8/18/1976 HOFFMANN LA ROCHE INC RO 21-5816/000 24R,25-
DIHYDROXYCHOLECALCIFEROL
2746 I III 8/10/1976 AMERICAN NATIONAL CAN CO LAMINATED PACKAGING FILMS (THIS FORMERLY
HELD BY CONTINENTAL CAN CO.)
2747 A III 8/2/1976 3M DRUG DELIVERY SYSTEMS SCOTCHPAK™9727, 2 MIL POLYESTER FILM
LAMINATE
2748 I II 8/20/1976 WESTWOOD SQUIBB KENALOG CREAM
PHARMACEUTICALS INC
2750 A III 9/15/1976 DUPONT PERFORMANCE POLYMERS DELRIN® ACETAL RESIN
2751 I II 9/17/1976 NAPP CHEMICALS INC N-ACETYL PROCAINAMIDE HCL
2752 I II 8/13/1976 DELVCO INDUSTRIES INC PACKAGING GUIDELINE
2753 I II 10/15/1976 KYOWA HAKKO KOGYO CO LTD L-CYSTINE & DERIVATIVE L-CYSTINE HCL & N-
ACETYL-L-CYSTEIN
2754 I II 10/27/1976 A INC ZETA/PLUS PRE-TEK (3" NORMAL DIAMETER)
CARTRIDGES FOR PHARMACEU. USE
2755 I I 10/26/1976 MERCK SHARP & DOHME RESEARCH FACILITIES & CONTROLS FOR MERCK FROSST
LABS LABS FOR TROCOSONE
2757 A II 10/8/1976 3M DRUG DELIVERY SYSTEMS DIV CORDRAN (FLURANDRENOLIDE) TAPE
2758 I II 9/27/1976 KV PHARMACEUTICAL CO HYBEPHEN -LA CAPSULES
2759 I II 8/10/1976 BUCHLER AND CO QUINIDINE SULFATE AND QUINIDINE PRODUCTS
Page 74
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
2805 I II 11/22/1976 KESTREL THERMAL DISINFECTION UNIT, CONTACT LENS
CARRYING/STORAGE CASE-FACILS
2807 I II 11/22/1976 INDUSTRIA CHIMICA PROFARMACO SPA HYDROXYZINE HCL
2808 I II 11/29/1976 INDUSTRIA CHIMICA PROFARMACO SPA HYDROXYZINE PAMOATE
2809 A II 12/10/1976 OLON SPA CLIDINIUM BROMIDE
2811 A IV 12/6/1976 DDP SPECIALTY ELECTRONIC SILASTIC™ MDX-4-4210 BIOMEDICAL GRADE
MATERIALS US 9 LLC ELASTOMER
2813 I II 12/22/1976 SYNTEX USA INC SYNTHESIS OF RS-40974-00-00-0
2814 I II 12/15/1976 INDUSTRIE CHIMICHE FARMACEUTICHE CHLORTHALIDONE
ITALIANE SPA
2815 I II 12/14/1976 ORGANON INC DEXAMETHASONE ACETATE
2816 I II 12/16/1976 ORGANON INC DEXAMETHASONE
2817 I II 1/7/1977 CILAG CHEMIE AG AMANTADINE HCL
2818 I II 1/3/1977 KV PHARMACEUTICAL CO POTASSIUM CHLORIDE SUSTAINED RELEASE
CAPSULES 600MG
2819 I II 1/22/1977 SYNTEX USA INC RS-44872-00-10-3 (d,l-1[2,4-dichloro-beta-[4-
chlorobenzyl)thio]pheneth
2820 I II 1/25/1977 LILLY RESEARCH LABORATORIES DIV EMETINE HCL INJECTION
ELI LILLY AND CO
2821 I II 1/4/1977 MALLINCKRODT CHEMICAL INC OXYCODONE HYDROCHLORIDE PURIFIED
RECRYSTALLIZED
2822 A IV 12/23/1976 EVONIK NUTRITION AND CARE GMBH EUDRAGIT® E 30 D ACRYLATE ESTER
COPOLYMER COATING
2823 I II 12/23/1976 UNION CARBIDE CORP XENON-133 PL AND XENON-133 P2
2824 I III 12/8/1976 WRAPS INC LAMINATES AND FILM-COATED PAPERS
2826 I II 1/24/1977 BARNES-HIND PHARMACEUTICALS INC BARNES-HIND CLEANING SOL'N FOR SOFT
CONTACT LENSES (TRANS. TO DEVICES)
2827 I II 1/25/1977 BARNES-HIND PHARMACEUTICALS INC BARNES-HIND RINSING SOLUTION FOR SOFT
CONTACT LENSES(TRANS.TO DEVICES)
2829 I II 1/26/1977 BARNES-HIND PHARMACEUTICALS INC BARNES-HIND STORAGE CASE FOR SOFT
CONTACT LENSES
2830 I II 12/30/1976 SIGMA F AND D DIV LTD CYCLOHEXIMIDE
2832 I II 1/28/1977 LAKE AND CRUICKSHANK QUINIDINE PRODUCTS
2833 I II 1/12/1977 TEVA PHARMACEUTICAL INDUSTRIES ACETAZOLAMIDE
LTD
2834 I II 1/13/1977 KOLMAR LABORATORIES INC MANUFACTURING SITE FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
2835 I II 1/13/1977 KOLMAR LABORATORIES INC MANUF & PACKAGING OF DRUG PRODUCTS AT
THE MILWAUKEE, WIS. FACILITY
2836 A III 1/26/1977 SABIC INNOVATIVE PLASTICS VALOX RESINS
2837 I II 1/27/1977 WAITAKI INTERNATIONAL BIOSCIENCES CHYMOTRYPSIN AND/OR TRYPSIN
SUB WAITAKI CANADA LTD
2838 I II 1/25/1977 BARNES-HIND PHARMACEUTICALS INC STORAGE AND RINSING SOLUTION FOR SOFT
CONTACT LENSES(TRANS.TO DEVICES)
Page 75
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
2839 A III 1/1/1977 SEKISUI VOLTEK LLC VOLARA FOAMS---CROSS-LINKED
POLYETHYLENE FOAMS
2840 I II 2/4/1977 DELMAR CHEMICALS INC TOLBUTAMIDE (COARSE)
2841 I II 2/4/1977 DELMAR CHEMICALS INC TOLBUTAMIDE (FINE)
2842 A III 1/14/1977 TEKNI-PLEX INC COMPOSITION AND MANUF PROCESSES FOR
PACKAGING MATERIAL
2843 I II 2/7/1977 SIGMA F AND D DIV LTD CHOLIC ACID SODIUM SALT
2844 I II 1/3/1977 UNITED STATES STEEL CORP POLYSTYRENE COMPOUNDS
2847 I II 2/4/1977 PLIVA PHARMACEUTICAL CHEMICAL MECLIZINE HCL
FOOD & COSMETIC INDUSTRY
2848 I II 1/28/1977 BARNES-HIND PHARMACEUTICALS INC BOILING AND RINSING SOLUTION FOR SOFT
CONTACT LENSES(TRANS.TO DEVICES)
2849 I II 1/26/1977 BLASCHIM SPA DEXAMETHASONE 21 SODIUM PHOSPHATE
2850 I II 1/26/1977 BLASCHIM SPA PREDNISOLONE 21 DISODIUM PHOSPHATE
2851 I II 1/26/1977 BLASCHIM SPA TRIAMCINOLONE DIACETATE
2852 I II 1/26/1977 BLASCHIM SPA TRIAMCINOLONE ALCOHOL
2853 A II 2/1/1977 TRIFARMA SPA TRIFLUOPERAZINE HYDROCHLORIDE
2854 I II 2/3/1977 NATIONAL INSTITUTES OF HEALTH LYMPHILIZED PRODUCT OF AMINOPTERIN (NSC
CLINICAL CENTER 739), 50MG
2855 A IV 2/8/1977 BASF SE LUDWIGSHAFEN KOLLIDON 30 ORIGIN USA
(POLYVINYLPYRROLIDONE/POVIDONE/PVP)
2856 I II 2/16/1977 UPJOHN CO HYDROXYPROGESTERONE CAPROATE
2857 I II 2/10/1977 GANES CHEMICALS INC PENNSVILLE DEHYROACETIC ACID & SODIUM
DIV DEHYDROACETATE
2858 I II 1/19/1977 API SYSTEM SA MASTER FORMULA RECORDS
2859 I II 2/10/1977 TAKEDA CHEMICAL INDUSTRIES LTD ESTAZOLAM (TA-8)
2860 I II 2/15/1977 LONZA INC CHLORPROMAZINE HCL
2861 I II 2/7/1977 RP SCHERER CORP PRODUCTION FACILITY IN DETROIT, MICH.
2862 I II 2/10/1977 SCHERING AG FLUOCORTIN BUTYLESTER (RECOMMENDED
GENERIC NAME IS FLUOCORTIN BUTYL)
2863 I I 2/2/1977 BEECHAM LABORATORIES DIV OF FACILITIES AND CONTROLS
BEECHAM INC
2864 I II 2/24/1977 BOEHRINGER MANNHEIM GMBH DIHYDROXYPROPYLTHEOPHYLLINE
(DYPHYLLINE)
2865 I II 2/24/1977 BOEHRINGER INGELHEIM PHARMA KG DIHYDROERGOTOXINE METHANESULFONATE
(DEMS)
2866 I II 2/10/1977 SOCHINAZ SA DIHYDROERGOTOXINE METHANE SULFONATE
2867 I II 3/7/1977 MEDI PHYSICS INC INDIUM III OXINE (D FORMERLY HELD BY
DIAGNOSTIC ISOTOPES INC)
2868 I II 2/24/1977 SIGMA F AND D DIV LTD ACETYL-BETA-METHYLCHOLINE CHLORIDE
2869 I II 2/16/1977 ABBOTT LABORATORIES MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MCPHERSON, KANSAS.
2870 A II 2/18/1977 TEVA PHARMACEUTICAL INDUSTRIES ALLOPURINOL USP
LTD
Page 76
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
2871 I II 2/18/1977 PLANTEX LTD CHEMICAL AND QUINIDINE SULFATE
PHARMACEUTICAL WORKS
2872 A II 3/1/1977 TEVA PHARMACEUTICAL INDUSTRIES TRIMETHOPRIM USP
LTD
2874 A II 2/28/1977 SANOFI CHIMIE PREDNISONE
2875 I II 2/10/1977 UCB PHARMACEUTICALS INC PIRACETAM (NOOTROPIL)
2876 I II 2/24/1977 BUCKEYE CELLULOSE CORP SODIUM CARBOXYMETHYLDICELLULOSE
GLYCEROL (CLD)
2877 I II 3/2/1977 CILAG CHEMIE AG ECONAZOLE NITRATE
2879 I II 3/3/1977 APPLETON PAPER DIV NATIONAL CASH ASCOT HEAT SEAL STERILE PACKAGING 1A
REGISTER CO INC
2880 A III 2/15/1977 CLARIANT PLASTICS AND COATINGS DESICCANT PRODUCT LINES
USA INC
2881 I II 3/1/1977 CELANESE PLASTICS AND SPECIALTIES CRE 5G2-85D
CO
2882 I II 3/21/1977 LONZA RIVERSIDE PROCHLORPERAZINE, PROCHLORPERAZINE
EDISYLATE,PROCHLORPERAZINE MALEATE
2883 I II 3/18/1977 MALLINCKRODT CHEMICAL INC NALBUPHINE HYDROCHLORIDE CODE 3300
2885 I II 3/17/1977 PLIVA PHARMACEUTICAL CHEMICAL CHLORPROPAMIDE
FOOD & COSMETIC INDUSTRY
2886 I IV 3/25/1977 SIGMA F AND D DIV LTD ALPHA-AMYLASE III-A
2887 I II 3/22/1977 SIEGFRIED AG N-ACETYL PROCAINAMIDE HCL
2889 I II 3/21/1977 SCHERING AG HYDROCORTISONE HEMISUCCINATE
2890 I II 3/18/1977 LILLY RESEARCH LABORATORIES DIV NORTRIPTYLINE HCL CAPSULES
ELI LILLY AND CO
2891 I II 3/18/1977 LILLY RESEARCH LABORATORIES DIV NORTRIPTYLINE HCL SOLUTION
ELI LILLY AND CO
2892 I II 3/8/1977 HEINRICH MACK NACHF 5-FLUOROURACIL
2893 I III 3/25/1977 PARAMOUNT PACKAGING CORP COEXTRUSION HIGH DEN. POLYETHYLENE
W/ETHYLENE VINYL ACETATE COPOLYMER
2895 I II 3/30/1977 P F LABORATORIES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
2896 I II 4/6/1977 PFANSTIEHL LABORATORIES INC GLUCOSE POLYMER (G-130)
2897 I II 4/8/1977 BARNES-HIND PHARMACEUTICALS INC BARNES-HIND SOLUTION FOR SOFT CONTACT
LENSES
2898 I II 4/14/1977 GANES CHEMICALS INC PENNSVILLE DIMENHYDRINATE, BULK POWDER FORM
2899 I II 4/11/1977 SHIONOGI AND CO LTD SULFAMETHOXAZOLE N.F.
2900 I II 4/6/1977 SANOFI CHIMIE HYDROCORTISONE HEMISUCCINATE
2901 I II 4/7/1977 USV DEVELOPMENT CORP SUB RORER FACILS. & CONTROLS FOR AN ADDITIONAL
GROUP MANUF FACILITY IN MANALI, P.R.
2902 I II 4/19/1977 SOCIETE CHIMIQUE POINTET GIRARD QUINIDINE SULFATE
SA
2903 I II 3/22/1977 INDUSTRIA CHIMICA PROFARMACO SPA BENZBROMARONE BULK
Page 77
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
2904 I II 4/13/1977 ABBOTT LABORATORIES ERYTHROMYCIN PHOSPHATE
PHARMACEUTICAL PRODUCTS DIV
2905 I III 3/22/1977 UNIPAC CORP CLOSURE LINER-CAP-SEAL II BRAND
2906 I III 1/22/1973 3M PHARMACEUTICALS CLOSURE LINERS ST-25 AND SW-25 ---CAP-SEAL
BRAND
2907 I II 4/28/1977 ETHYL CORP IBUPROFEN
2908 A II 3/18/1977 DIPHARMA FRANCIS SRL AMITRIPTYLINE HYDROCHLORIDE
2909 I II 4/29/1977 H REISMAN CORP SODIUM SULFATHIAZOLE SESQUIHYDRATE &
SODIUM SULFATHIAZOLE
2910 I II 4/1/1977 DUPONT MERCK PHARMACEUTICAL CO FACILITIES AND CONTROLS
2911 A II 4/12/1977 SIEGFRIED EVIONNAZ SA BUPIVACAINE HCL
2912 I II 12/22/1976 ELI LILLY CO ZINC INSULIN CRYSTALS--ARGENTINA D-2912
2913 I II 10/26/1976 SYNTHETIC PRODUCTS CO SYNPRON 1375 PVC HEAT STABILIZER
2914 I II 9/14/1976 GLASROCK POREX DIV FACILITIES AND CONTROLS FOR T-17
2915 I II 10/4/1976 MICROBIOLOGICAL RESEARCH ACHROMOBACTER GLUTAMINASE
ESTABLISHMENT
2916 A III 5/2/1977 SUMITOMO BAKELITE CO LTD SUMILITE PRODUCTS SERIES
2919 I II 4/18/1977 CLM SPECIAL POLYMERS LTD SAUFLON 70 POLYMER
2920 I II 4/18/1977 CLM SPECIAL POLYMERS LTD SAUFLON 85 POLYMER
2921 I II 5/6/1977 ER SQUIBB AND SONS INC INSULIN
2922 A II 5/2/1977 SANOFI CHIMIE METHYLPREDNISOLONE HEMISUCCINATE
2923 A III 4/5/1977 WESTLAKE CHEMICAL CORP PVC RESINS
2924 I II 3/28/1977 MERCK SHARP AND DOHME RESEARCH FACILS., METHODS & CONTROLS FOR
LABORATORIES DIV MERCK AND CO INC PROCESSING & PACKAGING OF DRUG PRODS.
Page 81
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3042 I V 10/24/1977 SSL INTERNATIONAL LISTING OF PRECLINICAL TOXICOLOGY
STUDIES (CHLORHEXIDINE GLUCONATE 20%)
3043 I II 10/21/1977 SIGMA F AND D DIV LTD GLUTATHIONE OXIDIZED
3044 I II 9/29/1977 GELMAN SCIENCES INC ACROFLOW 121 AND PREFLOW N.F.R. FILTER
CARTRIDGE LINES
3045 I IV 11/8/1977 WM LEMAN INC NATURAL PEPPERMINT OIL
3046 I II 11/7/1977 HENKEL KG AA NOVATA R SUPPOSITORY BASES
3047 I II 11/8/1977 MONSANTO CO METHOTREXATE
3048 I II 10/25/1977 DINAMITE DIPHARMA SPA d-PROPOXYPHENE NAPSYLATE
3049 I II 11/14/1977 PACO PACKAGING INC LAKEWOOD FACILITY FOR DRUG PACKAGING
3050 I II 11/9/1977 PCR INC FACILITIES AND CONTROLS FOR THE
HUMACAO, PUERTO RICO PLANT
3051 I II 10/17/1977 SIGMA F AND D DIV LTD L-ALPHA-PHOSPHATIDYL CHOLINE II-S
3052 I II 10/18/1977 DIPHARMA FRANCIS SRL SPIRONOLACTONE
3053 I II 11/17/1977 PFIZER INC TESTOLACTONE, USP
3054 I II 11/17/1977 HOFFMANN LA ROCHE INC BIOTIN
3055 I II 11/11/1977 DESMO CHEMICAL CORP BENBROMARONE AS MANUF BYRSA. CORP,
ARDLEY, N.Y.
3056 I I 11/1/1977 GAELEO LTD METHODS, FACILITIES AND CONTROLS
3057 I II 8/30/1977 DISCO LTD MICRO-ENEMA
3058 I II 11/21/1977 CYCLO PRODUCTS INC CHLORPROMAZINE HCL U.S.P.
3059 I II 11/11/1977 TANABE SEIYAKU CO LTD DILTIAZEM HCL
3060 I II 11/22/1977 KYOWA HAKKO KOGYO CO LTD L-DOPAMINE HYDROCHLORIDE (3-
HYDROXYTYRAMINE HYDROCHLORIDE )
3061 I II 11/14/1977 DUPONT NUTRITION BIOSCIENCES APS VALPROIC ACID
3062 A II 11/9/1977 TEVA PHARMACEUTICAL INDUSTRIES 5-FLUOROURACIL
LTD
3063 I II 11/2/1977 HOFFMANN LA ROCHE INC URSODEOXYCHOLIC ACID (RO13-1798)
3064 I II 11/4/1977 STAUFFER CHEM CO EMCOMPRESS (DICALCIUM PHOSPHATE
DIHYDRATE)
3065 I II 11/23/1977 MILTON ROY CO PHP (HEFILCONA) SOFT CONTACT LENS
BUTTONS
3066 I II 10/13/1977 KIMIA FARMA QUINIDINE SALTS
3067 I II 11/2/1977 HOFFMANN LA ROCHE INC CHENODEOXYCHOLIC ACID TABLETS, 250MG
(R08-2871)
3068 I II 11/9/1977 PHARMA-WALDHOF GMBH GLUTATHIONE REDUCED (GSH)
3069 I II 10/31/1977 ROHM CHEMICAL LABORATORY CO LTD MANUF PROCESSES OF CAP-PLATE MENICON &
MAFILCON SOFT CONTACT LENS MAT.
3070 I II 11/23/1977 OLC LABORATORIES INC STANDARD OPERATING PROCEDURES FOR
DISTRIBUTING L-TRYPTOPHAN
3072 I II 11/9/1977 ROUSSELL UCLAF ESTRADIOL VALERATE
3075 I II 11/21/1977 SIEGFRIED AG DIBENZOSUBERONE
3076 I I 11/15/1977 THE WEST CO PLASTIC CONTAINER DIV FACILS & CONTRLS-PLEASANTVILLE, NJ (THIS D
SUB OF THE WEST COMPANY FORMERLY CITATION PLASTIC
3077 I II 12/6/1977 CYCLO PRODUCTS INC TRIFLUORPERAZINE HCL NF
Page 82
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3078 I II 12/6/1977 CYCLO PRODUCTS INC PROCHLORPERAZINE MALEATE U.S.P.
3079 I II 12/6/1977 CYCLO PRODUCTS INC IMIPRAMINE HCL U.S.P.
3080 I II 11/29/1977 RHONE POULENC RORER TRIFLUOPERAZINE CHLORHYDRATE
PHARMACEUTICALS INC
3081 I II 12/8/1977 WEST PHARMACEUTICAL SERVICES INC OAK STREET LIQUID DRUG PRODUCTION,
LAKEWOOD, NEW JERSEY
3082 A III 11/14/1977 WEBER INTERNATIONAL PACKAGING CO PLASTIC BOTTLES
LLC
3084 I II 11/15/1977 STANDARD PASTE AND GLUE CO INC ADHESIVE FORMULATION-S-200-K-1-B
3085 I II 11/21/1977 INDENA GRUPPO INVERNI DELLA BEFFA CASANTHRANOL (THIS D FORMERLY HELD BY
INVERNI DELLA BEFFA, ITALY)
3086 I II 12/5/1977 LAOB LABORATORIO OPOTERAPICO SODIUM HEPARIN USP
BRASILEIRO SA
3087 I II 11/22/1977 PLANTEX LTD CHEMICAL AND TOLNAFTATE U.S.P.
PHARMACEUTICAL WORKS
3088 I II 12/9/1977 GENEVA GENERICS FACILITIES AND STANDARD OPERATING
PROCEDURES
3090 I II 12/15/1977 GRAVURE FLEX CORP FACILITIES & CONTROLS--SPECIALITY
LAMINATIONS
3091 I II 12/12/1977 GANES CHEMICALS INC PENNSVILLE DIBENZOSUBERONE BULK FORM
3092 I II 11/21/1977 LONGVIEW FIBRE CO PACKAGING MATERIALS
3093 I II 11/21/1977 MASCHEMIJER AROMATICS INC FRAGRANCES
3094 I II 12/14/1977 SHAWANO PAPER MILLS INC GRADE NO. 181-1-165-3 WHITE MG FOIL
MOUNTING TISSUE
3095 I II 12/14/1977 NORTHWESTERN CHEMICAL CO GLYCEROL MONOSTEARATE
3096 I II 12/15/1977 ARLIN MANUFACTURING CO INC TEAR TAPES
3097 I II 1/9/1978 ANTIBIOTICOS SPA HYDROCORTISONE 21-HYDROGEN, SUCCINATE,
BULK, NON-STERILE
3098 I II 1/9/1978 SYNTEX OPHTHALMICS INC CONTACT LENSES
3099 I II 1/3/1978 ANTIBIOTICOS SPA ENDRYSONE (BULK, NON-STERILE, NON-
MICRONIZED & MICRONIZED)
3100 I II 1/3/1978 ANTIBIOTICOS SPA DESONIDE, BULK, NON-STERILE, NON-
MICRONIZED & MICRONIZED
3101 I II 12/16/1977 AM TODD CO NATURAL OILS-PEPPERMINT & SPEARMINT
FRACTIONATED (REDISTILLED)
3102 I II 1/13/1977 SYNTEX USA INC SILAFOCON A
3103 I II 1/13/1977 GRUPPO LEPETIT SPA L-ALANOSINE
3104 I II 12/27/1977 ANTIBIOTICOS SPA MEDRYSONE USP XIX, NON-MICRONIZED AND
MICRONIZED
3105 I II 1/3/1978 ANTIBIOTICOS SPA BETAMETHASONE 17-VALERATE, NF BULK, NON
STERILE, NON MICRON & MICRON
3106 I II 1/6/1978 E MERCK DIOCTYL SODIUM SULFOSUCCINATE (45%
SOLUTION)
3107 I II 12/27/1977 ANTIBIOTICOS SPA PREDNACINOLONE ALCOHOL, MICRONIZED &
NON MICRONIZED
Page 83
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3108 I II 1/16/1978 ANTIBIOTICOS SPA FLUROMETHOLONE-(BULK, NON-MICRONZIED &
MICRONIZED)
3109 I II 12/27/1977 ANTIBIOTICOS SPA 6-ALPHA-METHYLPREDNISOLONE-21-
HYDROGEN SUCCINATE
3110 I II 12/27/1977 KNOLL AG LUDWIGSHAFEN HYDROXYZINE HYDROCHIORIDE
3112 I II 1/3/1978 ANTIBIOTICOS SPA FLUOCINONIDE (BULK, NON STERILE, NON-
MICRONIZED & MICRONIZED)
3113 I IV 11/18/1977 COLORPLAST LTD PLASKO WHITE 80-F
3114 I III 12/22/1977 CORNING GLASS WORKS PHARMACUETICAL ROLLER BOTTLES-PRODUCT
NO.25140
3115 I IV 1/11/1978 NAARDEN UOP FRANGANCES LADINA FRAGANCES RO 57.836
3116 A II 12/27/1977 SIEGFRIED PHARMACHEMIKALIEN DOPAMINE HYDROCHLORIDE
MINDEN GMBH
3118 I II 11/17/1977 SHIONOGI AND CO LTD KEFLEX R SUSTAINED RELEASE CAPSULES
(CEPHALEXIN MONOHYDRATE LILLY)
3119 I II 12/30/1977 HOUBA INC METHODS, FACILITIES AND CONTROLS FRO d-
BIOTIN
3120 I II 12/15/1977 LA DREYFUS CO SOFT IDEAL R BUBBLE GUM BASE AND NT
CHEWING GUM BASE
3121 I II 1/26/1978 MERCK SHARP & DOHME LTD PREPARATION OF TEN STABLE ISOTOPE-
LABELLED COMPOUNDS
3122 I III 12/19/1977 EASTMAN CHEMICAL CO ETHYLENE METHYL ACRYLATE COPOLYMERS
(EMAC)
3123 I II 1/24/1978 MALLINCKRODT CHEMICAL INC DIOCTYL SODIUM SULFOSUCCINATE IN P E G
3124 I II 2/3/1978 LEDERLE LABORATORIES DIV FACILS & CONTROLS FOR LEDERLE
AMERICAN CYANAMID CO METHOTREXATE, INC. & LEDERLE
PARENTERALS
3125 I II 1/20/1978 ISOCHEM SA QUINIDINE PRODUCTS
3126 I II 1/24/1978 TRIO PRODUCTS INC FACILITIES AND CONTROLS
3127 A IV 2/16/1978 SHIN-ETSU CHEMICAL CO LTD L-HPC (LOW-SUBSTITUTED HYDROXYPYL
CELLULOSE)
3128 I II 1/5/1978 AMERSHAM CORP SUB RADIOCHEMICAL FACILS, CONTROLS & PERSONNEL-AT THE
CENTER FREEZE DRYING UNIT GLOUCESTER ENG
3129 I II 1/20/1978 KV PHARMACEUTICAL CO ELIXOPHYLLIN SUSTAINED RELEASE CAPSULES
125MG (THEOPHYLLINE)
3130 I II 1/20/1978 KV PHARMACEUTICAL CO ELIXOPHYLLIN SUSTAINED RELEASE CAPSULES
250MG. (THEOPHYLLINE)
3131 A II 2/27/1978 KYOWA HAKKO BIO CO LTD AMINO ACIDS
3132 I II 1/8/1978 PLANTEX LTD CHEMICAL AND ESTERIFIED ESTROGENS, U.S.P.
PHARMACEUTICAL WORKS
3134 I II 1/24/1978 CIECH POLFA FUROSEMIDE
3135 I II 12/15/1977 KV PHARMACEUTICAL CO PHENDIMETRAZINE TARTRATE SUSTAINED
RELEASE CAPSULES 100 MG.
3136 A II 1/23/1978 FIS FABBRICA ITALIANA SINTETICI SPA INDOMETHACIN
3137 I II 1/24/1978 WARD BLENKINSOP AND CO LTD LIDOCAINE (LIGNOCAINE)
Page 84
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3139 A II 2/28/1978 DIPHARMA FRANCIS SRL TOLBUTAMIDE USP
3140 I III 2/9/1978 AMERICAN NATIONAL CAN CO PAPER-FOIL-POLYETHYLENE LAMINATE FILM
3141 I II 1/4/1978 BOEHRINGER MANNHEIM GMBH TABLETTING AND ENCAPSULATING FACILITIES
3142 I II 2/1/1978 RHONE POULENC RORER ACETAMINOPHEN (BULK)
PHARMACEUTICALS INC
3143 I II 2/20/1978 PFANSTIEHL LABORATORIES INC L-GLUCOSE, C.P., CATALOG NO. G-117
3144 I II 2/28/1978 INDUSTRIA CHEMICA PRODOTTI SULFAMETHOXAZOLE
FRANCIS SPA
3145 I II 2/28/1978 DR REDDYS LABORATORIES LTD FLUNISOLIDE
3146 I II 3/10/1978 PRB CHEMIE QUINIDINE SULPHATE USP 19
3147 I II 2/8/1978 ISTITUTO CHEMICOTHERAPICO TRIMETHOPRIM BULK, BP 1973
ITALIANO
3148 I II 3/15/1978 MASSACHUSETTS INSTITUTE FACILITIES AND CONTROLS
TECHNOLOGY
3149 A II 3/15/1978 KYOWA HAKKO BIO CO LTD AMINO ACIDS
3150 I II 3/16/1978 CORD LABORATORIES INC DIV SJ THEOPHYLLINE CAPSULES, T.D.
TUTAG AND CO
3151 I II 3/3/1978 AKTIEBOLAGET LEO METHODS, FACILITIES AND CONTROLS
3152 I II 2/24/1978 ANDERSON PACKAGING INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES
3153 I II 2/14/1978 EKCO PRODUCTS INC DRAWN ALUMINUM UNIT DOSE CONTAINERS
3154 I II 2/27/1978 HEINRICH MACK NACHF THYMIDINE
3155 I II 3/27/1978 ABBOTT LABORATORIES FACILS., PROCEDS., & CONTROLS-AT THE
PHARMACEUTICAL PRODUCTS DIV BARCELONETA, PUERTO RICO PLANT
3156 I II 3/21/1978 CHEMIE GRUNENTHAL GMBH SUPIDIMIDE (FACILITIES AND CONTROLS) (CG
3033)
3157 I II 2/24/1978 ERCOPHARM L-ALPHA METHYLDOPA
3159 I II 1/31/1978 INDUSTRIE CHIMICHE FARMACEUTICHE DIPHENHYDRAMINE HCL & DIMENHYDRINATE
ITALIANE SPA
3161 I II 2/27/1978 PLANTEX USA INC DIV IKAPHARM INC SULFAMETHOXAZOLE, N.F.
3162 I II 2/28/1978 KV PHARMACEUTICAL CO THEOPHYLLINE SUSTAINED RELEASE
CAPSULES, 125 MG.
3163 I II 2/28/1978 KV PHARMACEUTICAL CO THEOPHYLLINE S.R. CAPSULES, 250 MG.
3164 A II 2/28/1978 FIS FABBRICA ITALIANA SINTETICI SPA DIAZEPAM
3165 I II 2/22/1978 SYNTHA DOPAMIN HCL
3166 I II 2/8/1978 CILAG CHEMIE AG ACETRIZOIC ACID
3167 I II 2/27/1978 MACH ENTERPRISES SODIUM HEPARIN
3168 I II 2/28/1978 ALZA CORP FACILITIES OF ALZA MEXICANA S.A. -ESTADO de
MEXICO
3169 I II 3/6/1978 SANOFI CHIMIE DIHYDROERGOTOXIN MESYLATE
3170 I II 2/8/1978 CILAG CHEMIE AG EUDRAGITr E
3172 I II 3/23/1978 SYNTEX USA INC CIPROCINONIDE-MANUF BY SYNTEX RES IN CA,
BAHAMAS CHEM DIV SYNTEX
Page 85
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3173 I II 3/23/1978 ARNAR-STONE LABORATORIES INC SVP FACILITY AT ARNAR-STONE LABS,INC-
MOUNT PROSPECT, ILL
3174 I II 3/24/1978 SYNTEX USA INC PROCINONIDE AS MANUF BY SYNTEX
RESEARCH IN CA, BAHAMAS CHEMICAL DIV.
3175 I II 3/16/1978 MITSUBISHI CHEMICAL INDUSTRIES LTD ESTRADIOL
3176 I II 4/4/1978 LYNE LABORATORIES INC PROCEDURES, FACILITIES AND CONTROLS
3177 I II 4/4/1978 LEON INDUSTRIES INC PROCEDURES, FACILITIES AND CONTROLS
(FORT LAUDERDALE, FLA)
3179 I II 3/13/1978 BAYER CORP THE COMPLETE BUTYL PRODUCT LINE
3181 I II 4/21/1978 PHARMAKINETICS LABORATORIES INC FACILITIES AND PROCEDURES
(ADMINISTRATIVE AND OPERATING)
3182 I II 4/11/1978 PENN CHEMICALS BV SUB SMITHKLINE TICRYNAFEN (AS PRODUCED AT THE CORK,
BECKMAN CORP IRELAND FACILITY)
3183 I II 3/31/1978 REITECH CORP ROFLEX P INK SERIES
3184 I IV 4/14/1978 FERRO PFANSTIEHL INC EGG PHOSPHATIDE
3185 I II 3/9/1978 RHONE-POULENC SANTE INC PERCHLORPERAZINE BIS-MALEATE ACID
3186 I II 4/6/1978 HOECHST AG OCTOPIROX
3188 I II 4/28/1978 SIGMA F AND D DIV LTD METHYLENE DIPHOSPHORIC ACID
3189 I II 4/28/1978 PFANSTIEHL LABORATORIES INC METHOTREXATE
3190 A II 4/28/1978 PHARMACIA AND UPJOHN SUB PFIZER TESTOSTERONE, USP
INC
3192 I II 3/20/1978 TAKASAGO PERFUMERY CO LTD FLAVORS, FACILITIES AND CONTROLS FOR THE
LOCATION IN JAPAN
3193 I II 4/5/1978 WYETH INC TEMAZEPAM
3195 I V 4/21/1978 AQUALON CO TOXICOLOGICAL STUDIES OF NATROSOL
HYDROXYETHYL CELLULOSE
3196 I II 5/17/1978 PHARMACIA AND UPJOHN 17a-METHYLTESTOSTERONE
3197 I IV 5/10/1978 ICI AMERICAS INC TWEEN 80 (POLYSORBATE 80)
3198 I II 5/11/1978 ROUSSELL UCLAF DELTADIIODOMEDRANE
3199 I IV 4/25/1978 TAKASAGO PERFUMERY CO LTD MILK FLAVOR ON-1366
3200 I III 4/21/1978 AMERICAN NATIONAL CAN CO RETORT. PHARMACEU. PKGS-IN MT. VERNON,
OH. (CONTINENTAL CAN CO -ORIG)
3201 I II 5/11/1978 ANTIBIOTICOS SPA 17a-hydroxyprogesterone caproate usp, bulk, non-
sterile,non-micronized
3202 I III 5/19/1978 ALUMINUM CO AMERICA ALUMINUM CLOSURES W/COMPOSITE LINER
3203 I II 3/17/1978 PFANSTIEHL LABORATORIES INC SODIUM GLUCOHEPTONATE, NRC GRADE,
CATOLOG NO. S-105
3204 I I 3/8/1978 GLASFLEX FACILITIES AND CONTROLS FOR CONTACT
LENS MATERIALS
3205 I II 4/19/1978 G AND W LABORATORIES INC G FACILS & CONTROLS FOR G&W LABS,INC.,
SO. PLAINFIELD, NJ
3206 I II 4/13/1978 ALUMINUM CO AMERICA PHAR 9012 (PAPER MOUNTED LAMINATION OF
ALUM. FOIL & POLYOLEFIN-IN IOWA
3207 I II 4/28/1978 HEINRICH MACK NACHF CARBINOXAMINE MALEATE
3208 A II 5/25/1978 DR REDDYS LABORATORIES LTD NAPROXEN SODIUM
Page 86
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3209 A II 4/17/1978 SOCIETA ITALIANA MEDICINALI DIPYRIDAMOLE
SCANDICCI SIMS SRL
3210 I II 4/11/1978 FARMITALIA SPA ERGOTAMINE TARTRATE USP
3211 I II 5/23/1978 SYNTEX USA INC VALPROIC ACID
3212 I V 5/1/1978 AAA LABORATORY PROCEDURES FOR AMINO ACID ANALYSIS
3213 I II 4/12/1978 CONWAY CHEMICAL CO LTD BETHANECHOL CHL N.F.
3214 I II 5/17/1978 PCR INC 5-TRIFLUOROMETHYL-2-DEOXYURIDINE
3215 I II 5/5/1978 SIGMA F AND D DIV LTD 17 ALPHA-ESTRADIOL
3216 I IV 6/7/1978 ROUSSEL CORP HUMAN CHORIONIC GONADOTROPIN AS REC'D
FROM COHELFRED
3217 I II 6/23/1978 JANSSEN PHARMACEUTICA NV FACILS. & CONTROLS FOR PRODUCTION UNIT II
AT GEEL, BELGIUM
3218 I II 6/2/1978 TOWA PHARMACEUTICAL CO LTD GASTROLUFT TABLETS
3220 I II 6/14/1978 ROUSSELL UCLAF TESTOSTERONE CYPIONATE
3221 I II 6/6/1978 PARCOR SA FACILITIES AND CONTROLS
3222 I II 5/23/1978 FARMITALIA SPA CYANOCOBALAMIN (VITAMIN B 12)
3223 I II 6/16/1978 KYOWA HAKKO KOGYO CO LTD AMINO ACID BLEND "KYOWA", TR-1
3224 I II 6/15/1978 SIGMA F AND D DIV LTD DIETHYLENETRIAMINE PENTACETIC ACID
TRISODIUM ZINC SALT, 0.5 MOLAR SOL.
3225 I II 5/25/1978 ORMA ISTITUDO TERAPEUTICO NANDROLONE PHENYLPROPIONATE
3226 I II 6/22/1978 KOLMAR LABORATORIES INC FACILITIES AND CONTROLS AT THE DENTON, TX
LOCATION
3227 I III 9/27/1978 3M PHARMACEUTICALS AEROSOL VALVES
3228 I IV 5/31/1978 ICI LTD VICTREX (TM) POLYETHERSULFONO RESIN
3229 I II 5/28/1978 ORMA ISTITUDO TERAPEUTICO NANDROLONE DECANOATE
3230 A II 5/26/1978 TEVA PHARMACEUTICAL INDUSTRIES DOXEPIN HCL USP
LTD
3232 I II 6/2/1978 PACKAGING INK CORP FLEXO CELLOPHANE BLACK INK -FBK-7828
3234 I I 6/28/1978 ACF CHEMIEFARMA NV MANUFACTURING FACILITIES
3235 A IV 6/22/1978 CYTEC INDUSTRIES INC DIOCTYL ESTERS OF SULFOSUCCINIC ACID (NA,
CA, K, SALTS)
3236 I II 6/14/1978 LEMMON CO CHENODEOXYCHOLIC ACID CAPSULES, 250MG
3237 I II 6/5/1978 LEO PHARMACEUTICAL PRODUCTS LTD MECILLINAM FOR INJECTION
3238 I III 6/27/1978 FRANK B ROSS CO INC ROSS CARNAUBA WAX,POWDERED, REFINED #
80 (NATURAL & SYNTHETIC WAXES)
3239 I II 7/18/1978 SK&F LAB CO SUB SK BECKMAN CORP CIMETIDINE AND CIMETIDINE HCL
3240 I II 6/30/1978 ROCHE PALO ALTO LLC RS-37619-00-31-3 (RS-37619, TROMETHAMINE
SALT)
3241 I II 6/28/1978 DSM MINERA BV QUINIDINE GLUCONATE USP XIX
3242 I II 6/30/1978 SIGMA F AND D DIV LTD GLYCINE
3243 I II 6/22/1978 PLANTEX LTD CHEMICAL AND METHYLDOPA USP
PHARMACEUTICAL WORKS
3244 I II 7/6/1978 CYTEC INDUSTRIES BUSINESS UNIT SULFA DRUGS & MISC. SULFA PRODS
AMERICAN CYANAMID CO
Page 87
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3245 I II 1/16/1978 DIOSYNTH BV NORANDROSTENEDIONE --NANDROLONE
3246 I II 6/16/1978 MALLINCKRODT INC DIOCYTL SODIUM SULFOSUCCINATE IN
POLYETHYLENE GLYSOL 400
3247 I II 7/14/1978 KV PHARMACEUTICAL CO THEOPHYLLINE S.R. CAPSULES 125MG
3248 I II 4/11/1978 SCHARPER SPA ALGLUTAMOL
3249 I II 7/19/1978 MEDIMPEX NORTHAMERICA INC SULFADIMIDINE/SUPERSEPTYL (R)
3250 I II 6/2/1978 HOWMEDICA INC FACILITIES, METHODS & CONTROLS FOR THE
DEKNATEL DIVISION
3251 I I 5/29/1978 SANOFI WINTHROP INDUSTRIE PERSONNEL, METHODS, FACILITIES AND
CONTROLS
3252 I II 7/14/1978 KV PHARMACEUTICAL CO THEOPHILLINE S.R. CAPSULES 250MG
3253 I II 6/28/1978 BERK PHARMACEUTICALS LTD MANUFACTURING & PACKAGING OF 1-
TRYPTOPHAN (PACITRON TABLESTS, 500MG)
3256 I II 7/14/1978 SIGMA F AND D DIV LTD PROGESTERONE
3257 I II 7/21/1978 INDUSTRIE CHIMICHE FARMACEUTICHE PERSONNEL, FACILITIES AND
ITALIANE SPA CONTROLS(GENERAL OPERATING
PROCEDURES)
3258 I II 8/9/1978 BARNES-HIND PHARMACEUTICALS INC G. CONTROLS & DISTR. OF STERILE AND NON
STERILE PROD.(TRANS-DEVICES)
3260 I II 8/9/1978 WARD BLENKINSOP AND CO LTD PROBENECID
3261 I II 7/10/1978 DOW CHEMICAL CO VERSENE CA. CALCIUM CHELATING AGENT
3262 I III 5/25/1978 HATCO CHEMICAL CORP HATCOL 200
3263 I II 6/13/1978 UNION CARBIDE CORP 20% OXYGEN, 80% ARGON AS MANUF AT
TORRENCIE, CA
3264 I II 7/14/1978 STEROID SRL DICHLORPHENAMIDE (1,2 DICHLOR 3,5
DISULPHONAMIDO BENZENE)
3265 I II 4/11/1978 SCHARPER SPA FUROSEMIDE
3266 I I 7/21/1978 SIGMA F AND D DIV LTD PERSONNEL, FACILITIES AND CONTROLS
3267 I II 8/4/1978 BUCKEYE CELLULOSE CORP PRODUCT CLD-2
3268 I II 6/9/1978 BARDAHL CHICAGO INC FOOD MACHINERY GREASE
3269 I I 8/9/1978 PROSINTEX SPA PERSONNEL, FACILITIES AND CONTROLS
3270 I II 8/21/1978 MEDIMPEX NORTHAMERICA INC TOLBUTAMIDE USP XIX
3271 I II 8/11/1978 ORION CORP GENERAL METHODS, FACILITIES, AND
CONTROLS
3272 I II 6/2/1978 FERMION OY CYCLOPHOSPHAMIDE ORAL GRADE
3273 I II 7/21/1978 ORION CORP LTD PERPHENAZINE
3274 I II 7/31/1978 SIGMA F AND D DIV LTD CATABATE, SODIUM OXYBATE, GAMMA-
HYDROXYBUTYRIC ACID, SODIUM SALT
3275 I II 8/15/1978 UNION CARBIDE CORP 20% OXYGEN, 80% ARGON
3276 I II 6/20/1978 PHARMA-WALDHOF GMBH THYMIDINE
3277 I II 4/11/1978 SCHARPER SPA TRIAMTERENE
3278 I II 8/30/1978 SIGMA F AND D DIV LTD THYMIDINE
3279 I II 6/6/1978 ACE LUBE OIL CO LUBRICANTS: 1. ALUMPLEX FM 2-EP
3280 I II 8/10/1978 NATIONAL CANCER INSTITUTE DON (NORLEUCINE, 6-DIAZO-5-OXO-,L).
3281 I II 6/21/1978 FISKE BROTHERS REFINING CO OIL AND GREASES LUBRIPLATE
Page 88
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3282 I II 9/11/1978 FUJISAWA PHARMACEUTICAL CO LTD (TIARAMIDE HCL) GENERAL PROCEDURES
3283 I II 7/24/1978 SIGMA F AND D DIV LTD L-ALANINE
3285 I II 8/29/1978 ALPHA ONE BIOMEDICALS INC SYNTHETIC THYMOSIN (Ro 21-9199)
3286 I II 9/13/1978 SIFAVITOR SRL FACILITIES, PERSONNEL AND GENERAL
OPERATING PROCEDURES
3287 I II 8/7/1978 BASF AKTIENGESELLSCHAFT KOLLIDON 12 PF, POLYVINYLPYRROLIDONE
3290 I II 6/27/1978 ORION CORP LTD CHLORHEXIDINE GLUCONATE SOLUTION BP
20%
3291 I II 9/15/1978 SIFAVITOR SRL NORTRIPTYLINE HCL, USP
3292 I II 9/15/1978 SIFAVITOR SRL CYCLANDELATE
3293 A II 9/13/1978 OLON SPA CYPROHEPTADINE HYDROCHLORIDE
3294 I II 9/15/1978 SIFAVITOR SRL CHLOROTRIANISENE N.F. XIV
3295 I II 8/2/1978 SIGMA F AND D DIV LTD L-GLUTAMIC ACID
3297 I IV 9/21/1978 JOHN L ARMITAGE AND CO H-852 CLEAR LINER (CHEMICAL COATINGS)
3298 I IV 9/7/1978 ETHICHEM CORP SORBITOL
3300 I II 6/13/1978 UNION CARBIDE CORP UCC MASTER MILKER SYSTEM FOR TC-99
EXTRACTION FROM MO-99
3301 I I 9/19/1978 MEDI PHYSICS INC FACILITIES, CONTROLS, AND PERSONNEL AT
THE SOUTH PLAINFIELD, NJ LOC
3302 I I 9/19/1978 MEDI PHYSICS INC FACILS., CONTROLS & PERSONNEL-
EMERYVILLE, CA.--MEDI-PHYSICS NO. I-E
3303 I I 9/19/1978 MEDI PHYSICS INC FACILS.CONTROLS & PERSONNEL-ARLINGTON
HGTS, ILL--MEDI-PHYSICS NO. I-A
3304 I I 9/19/1978 MEDI PHYSICS INC FACILITIES, CONTROLS AND PERSONNEL AT
THE MIAMI LAKES, FLA LOCATION
3305 I I 9/19/1978 MEDI PHYSICS INC FACILITIES, CONTROLS AND PERSONNEL AT
THE ROSEMONT, ILL LOCATION
3306 I I 9/19/1978 MEDI PHYSICS INC FACILITIES, CONTROLS AND PERSONNEL AT
THE GLENDALE, CA FACILITY
3307 I I 7/8/1978 MEDI PHYSICS INC QUALITY CONTROL OF RAW MATERIAL & FINAL
PRODUCT RELEASE & DISTRIBUTION
3308 I I 9/19/1978 MEDI PHYSICS INC CORPORATE ADMIN &
3309 I II 6/15/1978 RECORDATI INDUSTRIA CHIMICA E PAPAVERINE BASE
FARMACEUTICA SPA
3310 A III 9/21/1978 NOVA CHEMICALS CORP SCLAIR POLYOLEFINE RESINS
3311 I II 7/18/1978 E MERCK TECHNETIUM TC-99m PYROPHOSPHATE NDA
17-913
3312 A II 8/9/1978 MITSUBISHI TANABE PHARMA CORP URSODEOXYCHOLIC ACID
3313 I IV 9/7/1978 AMERICAN CYANAMID CO CYMEL 1077
3314 I II 9/12/1978 SIGMA F AND D DIV LTD DL-CARNITINE
3315 I IV 6/28/1978 PVO INTERNATIONAL INC SAFFLOWER OIL
3316 I II 8/30/1978 RHONE POULENC RORER ZOPICLONE (26,267 R.P.)
PHARMACEUTICALS INC
3317 I II 10/6/1978 MASSACHUSETTS GENERAL HOSP 1 ALPHA-HYDROXYDIHYDROTACHYSTEROL 3
3318 I II 9/21/1978 SIEGFRIED AG TRIAMTERENE
Page 89
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3319 I III 9/5/1978 BCL LTD SINGLE-SIDE COATED REGENERATED
CELLULOSE FILMS
3320 I II 10/10/1978 APOTEX INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
3321 I II 8/30/1978 RHONE POULENC RORER FUMARATE (30,356 R.P.)
PHARMACEUTICALS INC
3322 I II 6/20/1978 YODOGAWA PHARMACEUTICAL CO LTD VALPROIC ACID
3323 I II 8/28/1978 SIGMA F AND D DIV LTD L-LYSINE MONO HCl
3324 I II 9/22/1978 ORTHO PHARMACEUTICAL LTD OPERATING PROCEDS & PLANT FACILS AT THE
DON MILLS, ONTARIO LOC.
3325 I IV 10/13/1978 SCM CORP PARAMOUNT B
3326 I II 10/20/1978 EGIS PHARMACEUTICALS PRIVATE LTD ALPHA METHYLDOPA USP XIX BULK
3327 I III 10/2/1978 AMERICAS STYRENICS LLC RUBBER MODIFIED POLYSTYRENE PRODS: 1.
TMDB-6800
3328 A II 6/14/1978 ANGELINI ACRAF SPA TRAZODONE HCL
3329 I II 7/13/1978 SUMIKA FINE CHEMICALS CO LTD SODIUM VALPROATE
3330 I IV 9/14/1978 M AND T CHEMS INC DM-9327 STABILIZER
3331 I II 10/20/1978 CHINOIN PHARMACEUTCIAL AND FUROSEMIDE USP XIX, BULK
CHEMICAL WORKS CO LTD
3332 I II 10/3/1978 SCHERING AG SPIRONOLACTONE
3333 I II 7/12/1978 SOCIETE CHIMIQUE POINTET GIRARD QUINIDINE POLYGALACTURONATE
SA
3334 I II 7/4/1978 ORSAN SOCIETE ANONYME PURE L-GLUTAMIC ACID
3335 I II 7/4/1978 ORSAN SOCIETE ANONYME PHARMACEUTICAL GRADE L-GLUTAMIC ACID
3336 I II 7/4/1978 ORSAN SOCIETE ANONYME L-GLUMATIC ACID HCL
3337 I II 7/4/1978 ORSAN SOCIETE ANONYME CALIUM L-GLUTAMATE MONOHYDRATE
TETRAHYDRATE
3338 I II 7/4/1978 ORSAN SOCIETE ANONYME POTASSIUM L-GLUTAMATE
3339 I II 7/4/1978 ORSAN SOCIETE ANONYME POTASSIUM L-GLUTAMATE (LOW SODIUM
CONTENT)
3340 I II 7/4/1978 ORSAN SOCIETE ANONYME MAGNESIUM L-GLUTAMATE
3341 I II 7/4/1978 ORSAN SOCIETE ANONYME L-ASPARTIC ACID
3342 I II 9/27/1978 SIGMA F AND D DIV LTD PYRIDOXAL HYDROCHLORIDE
3343 I II 9/29/1978 MEDIMPEX NORTHAMERICA INC SPIRONOLACTONE USP XIX
3344 I I 10/24/1978 UPSHER SMITH LABS INC FACILITIES AND CONTROLS
3345 I II 10/11/1978 BOEHRINGER MANNHEIM GMBH ALPHA-METHYLDOPA, BULK FORM USP XIX
3346 I II 10/7/1978 MALLINCKRODT INC ZOMEPIRAC
3347 I V 10/26/1978 WEST PHARMACEUTICAL SERVICES STERILE PROCESSING FACILITES LOCATED IN
LAKEWOOD INC LAKEWOOD, NEW JERSEY.
3348 I II 10/24/1978 MEDIMPEX NORTHAMERICA INC NORETHISTERONE ACETATE
3349 I II 10/24/1978 SIGMA F AND D DIV LTD URIDINE
3350 I II 10/11/1978 BOEHRINGER MANNHEIM GMBH SPIRONOLACTONE (BULK FORM) USP XIX, BP
1973
3351 I II 10/31/1978 ROCHE PALO ALTO LLC BUTOCONAZOLE NITRATE
Page 90
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3352 I II 10/20/1978 KV PHARMACEUTICAL CO SEARLE ANTACID
3353 I II 11/10/1978 GEDEON RICHTER LTD NORETHISTERONE
3354 I II 10/24/1978 ANTIBIOTICOS SPA FLUMETHASONE 21-PIVALATE, MICRONIZED
AND NON-MICRONIZED
3355 I II 10/13/1978 ROCHE DIAGNOSTICS GMBH QUINIDINE GLUCONATE & SULFATE USP XIX
(BULK) & BP 1973
3356 I III 9/22/1978 AVON INDUSTRIAL POLYMERS LTD RUBBER COMPONENTS FOR AEROSOL VALVES:
1. AVON COMPOUND 55 P14
3357 I III 10/2/1978 JAITE PACKAGING PACKAGING LAMINATIONS: MMP-7
3358 I II 10/13/1978 MEDIMPEX NORTHAMERICA INC ERGOTAMINE TARTRATE
3359 I II 10/10/1978 ORION CORP LTD CHLORHEXIDINE ACETATE, BPC
3360 I III 10/23/1978 BRITISH SIDAC LTD TRANSPARENT CELLULOSE FILMS
3361 I II 11/20/1978 DELMAR CHEMICALS INC BRETYLIUM TOSYLATE, BULK FORM
3362 I II 11/8/1978 PARKE DAVIS AND CO CAPSULE PLANT OPERATION AT THE DETROIT,
MICHIGAN FACILITY
3363 I II 8/10/1978 SANOFI CHIMIE PROPIONYL PROMAZINE (PROPIOPROMAZINE)
3364 I II 8/29/1978 DINAMITE DIPHARMA SPA FUROSEMIDE USP
3365 I II 10/27/1978 SIGMA F AND D DIV LTD FUSARIC ACID
3366 I II 11/20/1978 DELMAR CHEMICALS INC HALAZEPAM
3367 A IV 11/8/1978 CAPSUGEL MANUFACTURING INC EMPTY HARD GELATIN CAPSULES
3368 I II 9/11/1978 SYNTEX SA CHORIONIC GONADOTROPIN
3369 I III 10/13/1978 VERTA FOAM COMPONENTS LTD POLYETHER FOAM WADS 1. VFC 70
3370 I II 11/20/1978 DELMAR CHEMICALS INC OXTRIPHYLLINE, BULK FORM
3371 I IV 9/8/1978 WARNER JENKINSON CO FLAVORS 1. 0042 VANILLA BOURBON NAT AL WS
Page 91
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3384 I II 12/1/1978 JANSSEN PHARMACEUTICA NV CHEMICAL PRODUCTION & CONTROL OF BPC'S
FOR INVESTIGATIONAL USE IN BEERSE,
BELGIUM.
3385 I III 10/24/1978 MORTON INTERNATIONAL INC EPOXY ADHESIVES CONTAINING P-32 BLACK
PAST
3386 I II 12/1/1978 DSM ANDENO GMBH QUININE HYDROCHLORIDE FF II / NF XI
3387 I II 11/14/1978 BRACCO IND CHIMICA SPA (B15000), IOPAMIDOL, BULK FORM
3388 I II 11/30/1978 MEDIMPEX NORTHAMERICA INC PHARMACOLOGY AND TOXICOLOGY
INFORMATION REGARDING PROPELLANT HFA-
134A (GR106642X)
3389 I II 11/1/1978 DSM MINERA BV QUINIDINE SULFATE
3390 I II 12/15/1978 MERCK SHARP AND DOHME RESEARCH MERCK
LABORATORIES DIV MERCK AND CO INC
Page 95
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3508 I II 4/18/1979 NAPP TECHNOLOGIES INC G & CONTRL PROCEDS.--PRODUCT. OF
HYDROXYZINE PAMOATE NF XIV-LODI,NJ
3509 I II 4/20/1979 HOECHST CELANESE CORP FACILITIES, PERSONNEL & GENERAL
OPERATING PROCEDURES (COVENTRY, R.I.)
3510 I IV 4/4/1979 DEGUSSA CORP ELCEMA MICROFINE CELLULOSE
3511 I II 3/27/1979 SIEGFRIED AG PROPOXYPHENE NAPSYLATE
3512 I IV 1/18/1979 ER SQUIBB AND SONS INC PLACEBO FOR FLUPHENAZINE HCL TABLETS
3513 A II 3/8/1979 FIS FABBRICA ITALIANA SINTETICI SPA FUROSEMIDE
3514 A II 3/2/1979 DIPHARMA FRANCIS SRL CHLORPROPAMIDE
3515 I II 4/2/1979 IRISH FINE CHEMICALS LTD TRIFLUOPERAZINE
3516 A II 3/30/1979 DIPHARMA FRANCIS SRL TRIAMTERENE USP
3517 I II 3/5/1979 DIOSYNTH BV PREGNANT MARE SERUM GONADOTROPHIN
(PMSG) FROM PREGNANT MARE PLASMA
3518 I II 3/14/1979 ELI LILLY AND CO ROTOWEIGH (TM) CAPSULE WEIGHING
MACHINE AT USED IN THE INDIANAPOLIS PL
3519 I II 2/10/1979 BACHEM FINE CHEMICALS INC PENTAPEPTIDE, L-ARG-L-LYS-L-ASP-L-VAL-L-TYR
Page 97
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3565 I II 7/6/1979 INDUSTRIE CHIMICHE FARMACEUTICHE PROPRANOLOL HCL.
ITALIANE SPA
3566 I II 7/20/1979 UPJOHN CO AT-125 (U-42,126) ANTI-TUMOR AGENT
3567 A III 7/11/1979 AMCOR RIGID PLASTICS USA LLC MANUFACTURING OF INJECTION MOLDED
PARTS OR CLOSURE COMPRESSION MOLDED
PARTS
3568 I II 7/20/1979 SYNTEX USA INC RS-5888R
3569 I III 7/17/1979 WEST CO CR-1 CHILD RESISTANT CLOSURE
3570 A II 7/20/1979 SANOFI CHIMIE HYDROCORTISONE ACETATE
3571 I II 7/6/1979 PROSINTEX INDUSTRIE CHIMIQUE FACILITIES, PERSONNEL & GENERAL
ITALIANE SRL OPERATING PROCEDURES IN MILAN, ITALY
3572 I V 8/9/1979 AYERST LABORATORIES INC DIV PRECLINICAL STUDIES USING AY-25,650;
AMERICAN HOME PRODUCTS CORP SCHALLY ANALOGUE; (D-TRP6)-LH/RH
3573 I II 8/6/1979 ADRIA LABORATORIES INC DIV MANUFACTURING SITE, FACILITIES,
ERBAMONT INC PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PLAIN CITY, OHIO.
3574 I III 8/7/1979 BP CHEMICALS SA POLYETHYLENE PLASTIC PELLETS: PRODUCT
NO. DFDM 0111 (NATURAL)
3575 I IV 8/10/1979 HORII PHARMACEUTICAL INDUSTRIES BAROS TM EFFERVESCENT GRANULES
LDT
3576 I II 8/9/1979 AYERST LABORATORIES INC DIV G & CONTROL PROCEDS FOR INJECT. DOS
AMERICAN HOME PRODUCTS CORP FORM AY-25,650; SCALLY ANALOGUE
3577 I II 7/31/1979 RECKITT AND COLMAN PRODUCTS LTD PHARMACEUTICAL PRODUCTION FACILITY
PHARMACEUTICAL DIV
3578 I II 7/15/1979 BTB CO SPA ANISOTROPINE METHYLBROMIDE
3579 I II 8/7/1979 PARKEDALE PHARMACEUTICALS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ROCHESTER, MICHIGAN.
3580 I II 8/6/1979 DIOSYNTH BV ESTRADIOL BENZOATE
3581 I III 4/5/1979 ROHM AND HAAS CO BLENDEX SERIES (FORMERLY HELD BY BORG-
WARNER)
3582 I II 7/27/1979 DIAGNOSTIC ISOTOPES INC GENERAL PLANT MASTER FILE
3583 I II 7/22/1979 GANES CHEMICALS INC PENNSVILLE ALLOPURINOL, BULK FORM
3584 I II 8/6/1979 DIOSYNTH BV PREDNISOLONE TEBUTATE
3585 I III 2/7/1979 BORDEN CHEMICAL CO HOT MELT PRODUCTS: 1. HA-6335
3586 I III 4/5/1979 VINYL PLASTICS INC HEAT SEAL COATINGS, SP SERIES : 1. SP-2000
2. SP-2015
3587 I II 7/4/1979 LAEVOSAN GMBH AND CO KG LACTULOSE CONCENTRATE (BULK)
3588 I II 8/6/1979 DIOSYNTH BV ESTRONE MICRONIZED
3589 I I 8/28/1979 MCNEIL PHARMACEUTICAL DIV MANUFACTURING SITE, FACILITIES,
MCNEILAB INC PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN DORADO, PUERTO RICO.
3590 I II 7/20/1979 KINGLY PRODUCTS CORP PLASTIC MEDICINE SPOONS
Page 98
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3591 I II 8/10/1979 NOVOPHARM LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SCARBOROUGH, ONTARIO,
CANADA.
3592 I II 8/6/1979 DIOSYNTH BV METHYLPREDNISOLONE
3593 I II 6/15/1979 HOECHST AG ACESULFAME K (ACETOSULFAM-KGERMAN)
3594 A II 6/11/1979 BAXTER HEALTHCARE CORP CYCLOPHOSPHAMIDE, USP/EP
3595 I II 8/22/1979 ELI LILLY AND CO ACETAMINOPHEN CAPSULES
3596 I II 8/6/1979 DIOSYNTH BV METHYLPREDNISOLONE ACETATE
3597 I IV 8/16/1979 NORTHVILLE LABORATORIES F-1888 ARTIFICAL PEACH FLAVOR
3598 I II 8/21/1979 SYNTEX USA INC NEW DRUG SUBSTANCE RS-35909-00-00-0
3599 I II 8/22/1979 ORGAMOL SA TICLOPIDINE
3600 I III 7/30/1979 SOLVAY AND CIE SA PVC HOMOPOLYMER SOLVIC 271 GA
3601 I II 8/6/1979 DIOSYNTH BV METHYLPREDNISOLONE HEMISUCCINATE
3602 I II 8/22/1979 FINORGA TRITHIOZINE
3603 I II 9/11/1979 ERCOPHARM PROPANTHELINE BROMIDE
3604 I V 8/31/1979 CONTINENTAL PHARMA SA FACILS., METHODS & PRECLINICAL DATA FOR
PRODUCT CP 804 S
3605 A II 9/5/1979 SANOFI CHIMIE KETOPROFEN (19,583 R.P.)
3606 I II 9/19/1979 OTSUKA PHARMACEUTICAL CO LTD PROCATEROL HYDROCHLORIDE HEMIHYDRATE
Page 99
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3624 I III 9/21/1979 CUTTER BIOLOGICAL DIV MILES IV SOLUTIONS IN POLYOLEFIN BOTTLES
LABORATORIES INC
3625 I II 10/12/1979 PROGRESSIVE PLASTICS INC QUALITY CONTROL PROCEDURES RELATIVE TO
THE CLEVELAND, OHIO FACILITY
3626 I I 10/12/1979 ETHYL CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BATON ROUGE, LOUISIANA.
3627 I II 9/28/1979 METALLGESELLSCHAFT AG LITHIUM CARBONATE
3628 I III 10/5/1979 GUARDSMAN PRODUCTS ADHESIVES USED AS TUBE END SEALANT FOR
FLEXIBLE TUBES
3629 I II 10/5/1979 SCIENTIFIC PROTEIN LABORATORIES CONDRANOL BRAND OF CHONDROITIN 4-
INC SULFATE, BULK
3630 I II 10/3/1979 CILAG CHEMIE AG PRODUCT NDC 12502 - 1848 PHENAZOPYRIDINE
HCL
3631 I III 10/9/1979 SILGAN PET CORP PACKAGING MATERIALS FOR PHARMACEUTICAL
PRODUCTS
3632 I II 10/22/1979 PFANSTIEHL LABORATORIES INC 2-DEOXY-D-GLUCOSE, NRC-CATALOG NO. D-101
Page 103
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3744 I IV 3/10/1980 WARNER JENKINSON CO SPRAY DRIED FLAVORS:MNFG
MO.,NATURAL&ART.ORANGE FLAVOR #4168
3745 I II 3/7/1980 PROCOS SPA PROGLUMIDE
3746 A II 3/10/1980 GE HEALTHCARE INC THALLOUS CL (TL-201) (CYCLOTRON
OPERATION)
3747 I II 3/11/1980 NV ORGANON MEDROXYPROGESTERONE ACETATE MICRO
3748 A IV 3/10/1980 SHIN-ETSU CHEMICAL CO LTD PHARMACOAT AND METOLOSE ( LOW DEGREE
OF POLYMERIZATION ) METOLOSE(HIGH
DEGREE OF POLYMERIZATION)
3749 I II 3/10/1980 MEDI PHYSICS INC CYCLOTRON-I-123 EMERYVILLE,CA; SOUTH
PLAINFIELD,NJ; NORTH ARLINGTON,IL
3750 I II 2/28/1980 PHARMA-WALDHOF GMBH 5-BROMO-2' -DEOXYURIDINE (BDU)-PRODUCT
NO. 6706
3751 I IV 3/7/1980 PHILLIPS PETROLEUM CO PHILPRENE STYRENE-BUTADIENE
COPOLYMERS MNFG IN OKLAHOMA FACILITIES
3752 I II 3/10/1980 MEDI PHYSICS INC GALLIUM (GA 67) EMERYVILLE,CA; SOUTH
PLAINFIELD,NJ; NORTH ARLINGTON,IL
3753 I II 3/12/1980 DIOSYNTH INC HEPARIN SODIUM USP (BEEF LUNG)
3754 I II 3/12/1980 GANES CHEMICALS INC PENNSVILLE SOTALOL HCL
3755 I II 3/10/1980 MEDI PHYSICS INC KRYPTON (KR 81m) EMERYVILLE,CA;SOUTH
PLAINFIELD,NJ;NORTH ARLINGTON,ILL
3756 I II 2/28/1980 KV PHARMACEUTICAL CO HYOSCYAMINE SO4 & HYOSCYAMINE S04
W/PHENOBARBITAL SR CAPS-KREMERS
3757 I II 4/3/1980 MEIJI SEIKA KAISHA LTD PERSONNEL, PROCEDURES, FACILITIES AND
CONTROLS
3758 I II 4/7/1980 SIGMA F AND D DIV LTD BETA-ESTRADIOL-3-BENZOATE
3759 I II 4/7/1980 DIOSYNTH BV TRIAMCINOLONE MICRO
3760 I II 4/3/1980 UNIV IOWA PHARMACEUTICAL LEVO-ALPHA-ACETYLMETHADOL (LAAM)-
SERVICES COLL PHARMACY PRODUCED FOR NAT'L INST. DRUG ABUSE
3761 I IV 4/1/1980 V MANE FILS INC FLAVORS
3762 I IV 3/27/1980 REXENE CORP POLYPROPYLENE RESINS IN THE PP 11M AND
PP 21M SERIES-
3763 I II 4/7/1980 DIOSYNTH BV TRIAMCINOLONE ACETONIDE MICRO
3764 A III 3/21/1980 KLOCKNER PENTAPLAST FILMS FOR PHARMACEUTICAL PACKAGING
3765 I III 3/26/1980 3M PHARMACEUTICALS SECUR-A-SEAL EDGE SEALING TAPES: L. TAPE
YR-8027-2--IN MINNESOTA FACIL
3766 I II 4/9/1980 ARSYNCO INC PHENYL PROPANOLAMINE HCL
3767 I III 3/25/1980 CONTOUR PACKAGING CORP PLASTIC BOTTLES
3768 I II 4/17/1980 NAPP CHEMICALS INC MEPIVACAINE HCL
3769 I II 3/6/1980 POLAROID CORP PERSONNEL AND FACILITIES IN
MASSACHUSETTS
3770 I II 3/30/1980 SIGMA F AND D DIV LTD THIOPROLINE
3771 A II 4/15/1980 SANOFI CHIMIE METHYLPREDNISOLONE
3772 I III 3/25/1980 A INC 1DEP MEDIA & CARTRIDGES FOR
PHARMACEUTICAL USE
Page 104
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3773 I II 4/18/1980 FOOTE MINERAL CO LITHIUM CARBONATE, USP
3774 I II 3/28/1980 FISONS LTD IRON DEXTRAN INJECTION
3775 I II 4/15/1980 ROUSSELL UCLAF METHYLTESTOSTERONE USP
3776 A II 3/7/1980 FIS FABBRICA ITALIANA SINTETICI SPA
PENTAZOCINE HCI
3777 A III 4/10/1980 BAXTER HEALTHCARE CORP POLYOLEFIN (PL-325) CONTAINER- POUR
BOTTLE
3778 I II 4/7/1980 ANI PHARMACEUTICALS INC LITHIUM CARBONATE PILOT PROCESS
3779 I II 4/15/1980 ROUSSELL UCLAF METHYLPREDNISOLONE HEMISUCCINATE
3780 I II 3/14/1980 KNOLL AG LUDWIGSHAFEN PAMABROM (8-BROMOTHEOPHYLLINE-
ISOBUTANOLAMINE)
3781 I II 4/15/1980 ROUSSELL UCLAF TESTOSTERONE ENANTHATE
3782 A III 4/9/1980 SELIG SEALING PRODUCTS INC INNERSEAL MATERIALS
3783 I II 4/17/1980 THOMPSON HAYWARD CHEMICAL CO FORMULA T-DET N-9.5
3784 I III 4/17/1980 ALUMINUM CO AMERICA FORMED FOIL CONTAINERS IN THE PHAR
SERIES
3785 I II 3/24/1980 MUSKEGON CHEMICAL CO DIETHYL CARBAMAZINE
3786 I II 3/24/1980 ANTIBIOTICOS SPA FLUOROMETHOLONE 17-ACETATE NON-
MICRONIZED AND MICRONIZED
3787 I II 4/15/1980 ROUSSELL UCLAF TRIAMTERENE
3788 I II 3/26/1980 MALLINCKRODT SPECIALTY CHEMICALS FACILITIES-PERSONNEL-GEN. OPERATING
CO PROCEDURES RALEIGH NC CHEM. PLANT
3789 I I 3/31/1980 EON LABS G OF THE VIRGIN ISLANDS FACILITIES, PERSONNEL & GEN. OPERT.
INC PROCEDS-SPRINGFIELD GARDENS, NY
3790 I II 4/18/1980 M AND T CHEMS INC STANNOCHLOR (STANNOUS CHL., ANHYDROUS)
Page 106
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3835 A II 6/10/1980 JOHNSON AND JOHNSON CONSUMER NICORETTE
INC MCNEIL CONSUMER HEALTHCARE
DIV
3836 I II 6/12/1980 SIGMA F AND D DIV LTD STERILE FINISHED PRODUCTS AND STERILE
PROCESSING OPERATIONS LOCATED IN
ROCKAWAY, NJ
3837 I II 5/21/1980 DIOSYNTH BV ESTRIOL
3838 I II 6/16/1980 AMERCHOL CORP PROPAL (ISOPROPYL PALMITATE)
3839 I II 6/10/1980 LEO AB NICORETTE (R): PRODUCTION OF ION
EXCHANGE RESIN AT THE RAA, SWEDEN PLA
3840 A II 6/10/1980 INSTITUTO MASSONE S A HUMAN CHORIONIC GONADOTROPIN
3841 I II 5/21/1980 DIOSYNTH BV DEXAMETHASONE SODIUM PHOSPHATE
3842 I II 6/11/1980 CYTEC INDUSTRIES BUSINESS UNIT DISODIUM PAMOATE MONOHYDRATE (DISP)
AMERICAN CYANAMID CO
3843 I II 6/16/1980 NOVARTIS PHARMACEUTICALS CORP PERSONNEL, FACILS & GEN OPERATING
PROCEDURES AT EAST HANOVER, NJ.
3844 I II 5/30/1980 ANALYTICAL BIO LABORATORIES INC PERSONNEL FACILITIES & GENERAL
OPERATING PROCEDURES-COLUMBIA MO
3845 I II 5/21/1980 DIOSYNTH BV HYDROXYPROGESTERONE CAPROATE
3846 I II 6/25/1980 LONZA INC DEXTROMETHOPHAN HYDROBROMIDE
3847 I II 5/29/1980 IVERS LEE AG MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES .
3848 I II 6/18/1980 SIGMA F AND D DIV LTD DL-THERO-3,4-DIHYDROXYPHENYLSERINE
3849 A II 5/22/1980 ASPEN OSS BV NORETHINDRONE
3850 I II 5/28/1980 LYNE LABORATORIES INC PERSONNEL, FACILS, METHODS & CONTROLS
AT THE WESTWOOD, MASS. LOCATION
3851 I II 3/26/1980 ISF ISF 2522 (4-HYDROXY-2-0X0-1-PYRROLIDIN-
ACETAMIDE)
3852 I II 6/23/1980 MERCK SHARP & DOHME RESEARCH DIFLUNISAL
LABS
3853 I II 6/6/1980 NV ORGANON STABILIZED MIXTURE OF CONJUGATED
ESTROGENS
3854 I II 6/13/1980 MEDIMPEX NORTHAMERICA INC VINPOCETINE (CAVITON R)
3855 I II 5/29/1980 SCHUPBACH AG METHODS, FACILS & CONTROLS RELATED TO
PACKAGING MATERIALS
3856 I II 4/23/1980 PRB CHEMIE QUININE DERIVATIVES FACILITIES DESCRIPTION
Page 108
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3907 I II 8/11/1980 RACHELLE LABORATORIES INC FACILITIES, PERSONNEL & GENERAL
OPERATING PROCEDURES
3908 I II 7/17/1980 DIOSYNTH BV CORTISONE ACETATE MICRO
3909 I III 1/15/1980 CELANESE PLASTICS AND SPECIALTIES MEDICAL PACKAGING ADHESIVES;1.22188-54 IN
CO THE KENTUCKY FACILITY
3910 A II 7/18/1980 RECORDATI INDUSTRIA CHIMICA E DIPHENHYDRAMINE HCL USP
FARMACEUTICA SPA
3911 I II 6/16/1980 SELOC PHARMA AG MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF ISOSORBIDE DINITRATE
DILUTED BY SIFA LTD IN CLARE, IRELAND.
3912 I II 7/18/1980 POLIPHARM SPA IMIPRAMINE HCL USP
3913 I II 4/4/1980 DIOSYNTH BV L-PROPLYL-L-LEUCYL-GLYCINAMIDE (MIF)
3914 I II 8/5/1980 DEGUSSA AG WERK RADEBEUL L-ARGININE
3915 I II 7/21/1980 COSMA SPA SULFINPYRAZONE
3916 I II 7/21/1980 FBA PHARMACEUTICALS INC DIV CHLOROQUINE DIPHOSPHATE
BAYCHEM CORP
3917 I II 7/17/1980 DIOSYNTH INC HYDROCORTISONE MICRONIZED
3918 I II 7/18/1980 POLIPHARM SPA HYDRALAZINE HCL USP
3919 I II 7/16/1980 STANNIOLFABRIK BURGDORF AG MANUFACTURING FACILITIES FOR BLOW
EXTENSION THERMOPLASTIC MATERIALS
3920 I II 8/5/1980 DEGUSSA AG WERK RADEBEUL L-HISTIDINE
3921 I II 7/17/1980 DIOSYNTH BV HYDROCORTISONE ACETATEMICRO
3922 I II 7/18/1980 POLIPHARM SPA DOXYLAMINE SUCCINATE USP
3923 I II 8/18/1980 ASTRA USA INC FACILITIES AND CONTROLS AT THE WESTBORO,
MASS LOCATION
3924 I II 8/5/1980 DEGUSSA AG WERK RADEBEUL L-ORNITHINE HCL
3925 I II 7/24/1980 WEST PHARMACEUTICAL SERVICES INC MANUFACTURING FACILITIES
Page 110
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
3969 I II 11/3/1980 KV PHARMACEUTICAL CO THEOPHYL S.R. CAPS 125MG & 250MG
(THEOPHYLLINE)-FOR KNOLL PHARMA CO.
3970 I I 11/7/1980 WHITEHALL LABS DIV AMERICAN HOME PERSONNEL, FACILS, & GEN OPER PROCEDS
PRODS CORP FOR ELKHART, IN LOCATION
3971 I II 11/6/1980 JT BAKER CHEMICAL CO ZOMEPIRAC SODIUM DIHYDRATE
3972 I II 9/12/1980 BOEHRINGER MANNHEIM GMBH OXTRIPHYLLINE (CHOLINE THEOPHYLLINATE)
3973 I II 5/22/1980 DEGUSSA AG WERK RADEBEUL L-THREONINE (PYROGEN FREE)
3974 I II 10/23/1980 DIOSYNTH BV TESTOSTERONE
3975 I IV 11/6/1980 HETERENE CHEMICAL CO INC HETOXOL D(CETEARYL ALCOHOL&CETEARETH-
20) MNFG IN PATERSON,NJ FACILITY
Page 115
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4117 I II 4/10/1981 SYNCOR INTERNATIONAL CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SYLMAR, CALIFORNIA.
4118 A II 4/9/1981 TEVA PHARMACEUTICAL INDUSTRIES BETAMETHASONE VALERATE
LTD
4119 I II 4/1/1981 CHUGAI PHARMACEUTICAL CO LTD SG-75 (N-(2-HYDROXYETHYL) NICOTINAMIDE
NITRATE TABS
4120 A II 2/27/1981 TRIFARMA SPA THIORIDAZINE HYDROCHLORIDE
4121 I II 4/1/1981 SIGMA F AND D DIV LTD YOHIMBINE HYDROCHLORIDE
4122 I II 4/7/1981 DIOSYNTH BV HYDROCORTISONE SODIUM SUCCINATE
4123 I II 4/14/1981 ROCHE PRODS LTD RO 12-1989 (DIHOMO-GRAMMA-LINOLENIC ACID)
4124 I II 4/7/1981 HOECHST AG MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN FRANKFURT.
4125 I II 2/28/1981 YAMASA SHOYU CO LTD URIDINE, 5-BROMO-2' -DEOXY. THIS INFO WAS
SUBMITTED NCI/NIH
4126 A II 2/27/1981 TRIFARMA SPA FLUPHENAZINE HCL
4127 I III 11/20/1986 CP HALL CO MONOPLEX S-75 (D FORMERLY HELD BY ROHM
AND HAAS COMPANY)
4128 A II 3/31/1981 CURIUM US LLC THALLOUS CHLORIDE TI 201
4129 I II 4/7/1981 DIOSYNTH BV HEPARIN CALCIUM
4130 A II 2/27/1981 TRIFARMA SPA PERPHENAZINE USP
4131 I II 4/20/1981 GD SEARLE AND CO MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MT. PROSPECT, ILL.LOCATIO.
4132 I II 4/20/1981 H REISMAN CORP PSEUDOEPHEDRINE HCL; BULK
PSEUDOEPHEDRINE HCL
4133 I II 4/21/1981 WHEATON CLOSURES INC FACILITIES,CONTROLS & PERSONNEL
MILLVILLE, NJ
4134 A II 3/31/1981 CURIUM US LLC GALLIUM CHLORIDE GA-67
4135 I II 2/27/1981 INDUSTRIA CHIMICA MILANESE SPA MANUFACTURING SITE, PERSONNEL,
FACILITIES, AND GENERAL OPERATING
PROCEDURES AT MILANO, ITALY.
4136 I II 4/14/1981 PERKINS ELMER LIFE SCIENCES INDIUM-111 PRODUCED IN NORTH BILLERICA,
MASS FACILITIES
4137 I II 3/23/1981 ETHYL CORP ZOMEPIRAC SODIUM DIHYDRATE PROCESSED
MD UNIT, BATON ROUGE, LA
4138 I II 4/23/1981 SIGMA FOOD AND DRUG DIV SIGMA DIMETHYL SULFOXIDE
ALDRIDGE CORP
4139 A II 3/27/1981 SIMS SRL LIDOCAINE BASE CRYSTALLIZED & LIDOCAINE
HcL
4140 I II 3/3/1981 PROFARMACO SRL LIDOCAINE HCL & BASE---2-(diethylamino)-2-6
acetoxylidide hcl
4141 I II 3/24/1981 MAY AND BAKER LTD ACEBUTOLOL HCL/SECTRAL
Page 116
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4142 I I 3/16/1981 SMITH LABORATORIES INC MANUFACTURING SITE,
FACILITIES,PERSONNEL, AND GENERAL
OPERATING PROCEDURES .
4143 I II 4/13/1981 IMC CHEMICAL GROUP INC SUB ERYTHRITOL TETRANITRATE(ETN) MNFG IN
INTERNATIONAL MINERALS CHEMICAL SPANISH FORK, UTAH FACILITIES
CORP
4144 I II 4/16/1981 GANES CHEMICALS INC PENNSVILLE FLUTAMIDE
4145 I II 4/6/1981 CAMBREX PROFARMACO MILANO SRL NAPROXENE
4146 I II 1/31/1981 US COTTON LLC NICLOSAMIDE
4147 I III 1/23/1981 WACKER CHEMIE GMBH VINNOL H 70 DF
4148 A II 4/28/1981 TEVA PHARMACEUTICAL INDUSTRIES BETAMETHASONE DIPROPIONATE
LTD
4149 I II 4/8/1981 GEDEON RICHTER LTD FOR CHEMICAL WORKS OF GEDEON RICHTER,
LTD -BUDAPEST
4150 I II 5/5/1981 DIOSYNTH BV PREDNISOLONE SUCCINATE
4151 I I 5/7/1981 CCL CUSTOM MANUFACTURING INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN DANVILLE, ILL.
4152 I II 5/7/1981 INDUSTRIA FARMACEUTICA SERONO FACILITIES, CONTROLS & PROCEDURES FOR
SPA MANUF OF ANTI-hCG
4153 I I 5/1/1981 DENKA PHARMCEUTICAL CO LTD MANUF PROCEDS HUMAN CHORIONIC
GONADOTROPIN (HCG)
4154 I II 4/28/1981 GRINDSTED PRODUCTS SULFAMETHAZINE
4155 I II 5/5/1981 LYPHOMED INC MANUF. PROCEDS FOR OXYTOCIN INJECT
(BULK)--IN CHICAGO, ILL. FACILITIES
4156 I I 4/17/1981 VANGARD LABS DIV MIDWAY MED CO MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN GLASGOW, KENTUCKY.
4157 I I 2/18/1981 GAELEO LTD METHODS, FACILS. & CONTROLS FOR THE GR
OF POLYESTRADIOL PHOSPHATE
4158 I II 5/11/1981 MEIJI SEIKA KAISHA LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ASHIGARA, JAPAN.
4159 I II 5/21/1981 SCHERING PLOUGH AVONDALE CO RATHDRUM, COUNTY WICKLOW, IRELAND
4160 A III 4/23/1981 EASTMAN CHEMICAL CO ECDEL ELASTOMERS
4161 I II 4/29/1981 CENTRAL PHARMACEUTICALS INC PSEUDOEPHEDRINE HCL CAPS 120MG
4162 I III 5/1/1981 TECNOCAP LLC PACKAGING MATERIALS-CLOSURES
4163 I III 4/29/1981 FLEXEL INC NITROCELLULOSE & POLYMER COATED
CELLOPHANES
4164 A III 4/30/1981 BARNHARDT MANUFACTURING CO COTTON,RAYON AND POLYESTER
PHARMACEUTICAL COIL
4165 I II 5/21/1981 IRISH FINE CHEMICALS LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL AND GENERAL OPERATING
PROCEDURES IN RATHDRUM, IRELAND.
Page 117
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4166 I III 5/13/1981 EKA NOBEL INC PAPER CHEMICALS DIV BEROCELLS DEBONDING AGTS FOR PROCESS
FLUFF PULPS
4167 I II 3/31/1981 PROFARMACO SRL MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
4168 I II 5/7/1981 PLIVA PHARMACEUTICAL CHEMICAL GLUTETHIMIDE (CHEM NAME: 2-ETHYL-2-
FOOD & COSMETIC INDUSTRY PHENYL GLUTARIMIDE)
4169 I III 5/20/1981 BAXTER HEALTHCARE CORP PRODUCTION OF PARENTERAL INJ. - PLASTIC
CONTAINERS(PL-146) CAROLINA PR
4170 I I 5/21/1981 BRYAN LOFTUS MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN RATHDRUM, CO WICKLOW
IRELAND.
4171 I II 4/6/1981 G POHL BOSKAMP GMBH AND CO KG CR3 FLEXIBLE CONTAINER
4172 I II 5/21/1981 STUART PHARMACEUTICALS DIV ICI SDM 50 (STABILIZED 50/50 ISOSORBIDE
AMERICAS DINITRATE-LACTOSE MIXTURE)
4173 I II 5/29/1981 ABBOTT LABORATORIES HOSP STD TEST METHODS FOR TESTING SVP & LVP
PRODUCTS DIV PRODUCTS(PERIOD 5-1-80 - 5-1-81
4174 I II 5/28/1981 MARION LABORATORIES INC RESEARCH & DEVELOPMENT FACILS AT THE
KANSAS CITY MISSOURI LOCATION
4175 I II 5/4/1981 ONCOLOGY RESEARCH AND HEMATOPORPHYIN DERIVATIVE (PHOTOFIN)
DEVELOPMENT INC FOR HUMAN USE--CHEEKTOWAGA, NY
4176 I I 5/7/1981 SCHERING CORP SUB SCHERING MANUFACTURING SITE, FACILITIES,
PLOUGH CORP PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MANATI, PUERTO RICO.
4177 A III 5/8/1981 HOSPIRA INC CR3 FLEXIBLE CONTAINER
4178 A II 5/21/1981 BAYER AG LEVONORGESTREL
4179 I II 5/1/1981 CILAG CHEMIE AG ZOMEPIRAC SODIUM DIHYDRATE
4180 I II 6/1/1981 ABBOTT LABORATORIES HOSP STANDARD TEST METHODS FOR TESTING SVP &
PRODUCTS DIV LVP PRODUCTS (5-1-80 - 5-1-81)
4181 I II 6/10/1981 MERCK SHARP AND DOHME BV CORTICOTROPIN
4182 I II 6/23/1981 NAPP CHEMICALS INC LIDOCAINE HCL
4183 I II 5/7/1981 SISA INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CAMBRIDGE,
MASSACHUSETTS.
4184 I II 5/29/1981 ABBOTT LABORATORIES HOSP STD.CONTROL PROCEDURES,RAW DRUG
PRODUCTS DIV CODES FOR SVP & LVP PRODUCTS(5-80 5-81
4185 A II 5/27/1981 SIEGFRIED PHARMACHEMIKALIEN PSEUDOEPHEDRINE
MINDEN GMBH
4186 I II 6/12/1981 PHARMACO LABORATORIES INC METHDILAZINE--AT THE TITUSVILLE, FLA.
LOCATION
4187 I II 6/23/1981 NAPP CHEMICALS INC SILVER SULFADIAZINE
Page 118
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4188 I II 6/18/1981 ASAHI CHEMICAL INDUSTRY CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
4189 I I 5/26/1981 SALK INSTITUTE 4F-ANTAGONIST
4190 A III 6/22/1981 B BRAUN MEDICAL INC PACKAGING MATERIAL - QUALIFIED
COMPONENT VENDORS FOR THE EXECEL(R)
PLASTIC CONTAINER
4191 I II 6/24/1981 BIOCHEMIC GESELLSCHAFT MBH OXYTOCIN SOLUTION 200 I.U./ML
4192 A IV 6/18/1981 ASAHI KASEI FINECHEM CO LTD REFINED EGG PHOSPHATIDE
4193 I II 6/11/1981 ABBOTT LABORATORIES SELENIUM SULFIDE
PHARMACEUTICAL PRODUCTS DIV
4194 I II 5/29/1981 TANABE SEIYAKU CO LTD AMINO ACID MIXTURE ABBU
4195 A II 5/11/1981 CAMBREX PROFARMACO MILANO SRL LORMETAZEPAM
4196 I II 5/28/1981 PFIZER INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PARSIPPANY, NEW JERSEY.
4197 I II 6/30/1981 COMPANIA ESPANOLA DE SINTESIS TRIAMCINOLONE ACETONIDE USPXX
QUIMICA SA
4198 I II 6/1/1981 ABBOTT LABORATORIES HOSP STD CONTROL PROCEDURES,RAW DRUG
PRODUCTS DIV CODES FOR SVP & LVP PRODUCTS,5-80 5-81
4199 I III 5/22/1981 OLIN CORP LAMINAT. OF CELLOPHANE W/ALUM. FOIL OR
POLYPROPYLENE FILM, N.C. LOCAT
4200 I II 6/10/1981 DIOSYNTH BV METOCURINE IODIDE
4201 I II 6/5/1981 UDL LABORATORIES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ROCKFORD, ILLINOIS.
4202 I II 5/29/1981 TANABE SEIYAKU CO LTD AMINO ACID MIXTURE ABBX
4203 A II 6/12/1981 SPECGX LLC COMPAP™
4204 I II 6/19/1981 H REISMAN CORP PSEUDOEPHEDRINE SULFATE, BULK FORM
4205 I II 5/5/1981 FABBRICA ITALIANA SINTETICI SPA TRIMETHOPRIM USP, BULK FORM
4206 I II 7/8/1981 POLYSCIENCES INC INDICINE-N-OXIDE
4207 I II 7/3/1981 DIOSYNTH BV TRIAMCINOLONE DIACETATE
4208 I II 7/8/1981 SIGMA F AND D DIV LTD ADENOSINE, SIGMA GRADE
4209 I II 7/9/1981 LAPORTE ORGANICS FRANCIS SPA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
4210 I II 7/16/1981 AH ROBINS CO PLANT MASTER FILE FOR ARECIBO, PUERTO
RICO LOCATION
4211 I II 6/12/1981 FERMION OY SULPHINPYRAZONE USP 80
4212 I II 7/17/1981 LONZA RIVERSIDE AURANOFIN
4213 I II 6/5/1981 BIOCHEMIC GESELLSCHAFT MBH PLEUROMULIN
4214 I I 5/19/1981 CYANAMID GREAT BRITAIN LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN GOSPORT.
Page 119
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4215 I II 6/30/1981 KV PHARMACEUTICAL CO DIDRONEL TABLETS, 200 MG, MNFG IN
WESTPORT FACIL., ST.LOUIS, MISSOURI
4216 I II 7/22/1981 SANOL SCHWARZ PERSONNEL,FACILITIES AND GENERAL OP.
PROCEDURES, MONHEIM FACIL.
4217 I II 5/14/1981 FALK GMBH AND CO URSODEOXYCHOLIC ACID (URSOFALK CAPS)
4218 I II 6/15/1981 ORION CORP LTD CHLORHEXIDINE ACETATE BP 80
4219 I I 7/15/1981 JOHNSON AND JOHNSON MEDICAL INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDUES IN GURABO, PUERTO RICO.
4220 A II 3/18/1981 ESTEVE QUIMICA SA INDOMETHACIN FOR HUMAN USE
4221 I I 6/30/1981 HOVIONE SOCIEDADE QUIMICA LDA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
4222 I II 7/20/1981 PFANSTIEHL LABORATORIES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN WAUKEGAN, ILLINOIS.
4223 I II 7/21/1981 B BRAUN MEDICAL INC FACILITIES & GENERAL OPERATING PROCEDS
AT IRVINE, CALIF
4224 I II 7/22/1981 SANOL SCHWARZ ISOSORBIDE DINITRATE TRANSDERMAL
SUSPENSION
4225 I II 6/24/1981 HOFFMANN LA ROCHE INC RO 5-9963 (DESMETHYLMISON IDAZOLE
4226 I II 6/12/1981 LINSON LTD BENDROFLUMETHIAZIDE (BULK)
4227 I III 5/28/1981 BORDEN CHEMICAL CO CASCO FLEX ADHESIVE IN THE "NT" SERIES
4228 I II 7/28/1981 STEROID SRL NANDROLONE DECANOATE (USAN)
4229 I II 7/21/1981 MCGAW INC FACIL & GENERAL OPER PROCEDS AT
MILLEDGEVILLE, GA LOCATION
4230 I II 6/15/1981 SIEGFRIED AG OXYMETAZOLONE HCL (BULK)
4231 I II 6/16/1981 PERKINELMER LIFE ANALYTICAL IODINE-131-PRODUCED IN NORTH BILLERICA,
SCIENCES INC MA.
4232 I II 6/25/1981 PIERCE CHEMICAL CO DIMETHYL ADIPIMIDATE HCL
4233 A II 4/8/1981 PHARMACIA AND UPJOHN CO LLC TESTOSTERONE PROPIONATE
WHOLLY OWNED SUB OF PFIZER INC
4234 I II 8/3/1981 AYERST LABORATORIES INC DIV MANUFACTURING SITE, FACILITIES,
AMERICAN HOME PRODUCTS CORP PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ROUSES POINT, NEW YORK.
4235 I II 8/5/1981 TAIHO PHARMACEUTICAL CO INC FTORAFUR (ALSO CALLED FUTRAFUL OR
TEGAFUR)
4236 I II 8/6/1981 G POHL BOSKAMP GMBH AND CO KG NITROLINGUAL CHEWABLE CAPSULE
4237 I III 8/5/1981 POLYMER CORP POLYBOND ADHES. SYSTEMS IN THE GA-83
SERIES
4238 I III 11/11/1980 BASF AKTIENGESELLSCHAFT LUPOLEN 1810 H WHITE 950/LUPOLEN 1800H
NATURAL/POLYSTROL 143E WHT 200
4239 I II 6/26/1981 PHARMACIA AND UPJOHN TESTOSTERONE ENANTHATE USP
4240 A II 6/26/1981 CAMBREX PROFARMACO MILANO SRL CLORAZEPATE DIPOTASSIUM
4241 I II 7/29/1981 GANES CHEMICALS INC PENNSVILLE BUSPIRONE HCL
Page 120
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4242 A II 8/12/1981 ALBEMARLE CORP LITHIUM CARBONATE USP
4243 I II 8/5/1981 GLAXO WELLCOME INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MONTROSE, ANGEES,
SCOTLAND.
4244 I II 7/31/1981 AMERSHAM RADIOCHEMICAL CENTER INDIUM IN 111 OXINE
4245 A II 8/13/1981 PHARMACIA AND UPJOHN CO LLC TESTOSTERONE CYPIONATE USP KALAMAZOO
WHOLLY OWNED SUB OF PFIZER INC
4246 A II 8/6/1981 FERMION OY METHOTREXATE
4247 I II 7/21/1981 PFANSTIEHL LABORATORIES INC FTORAFUR (1-TETRAHYDRO-2-FURANYL) 5-
FLUOROURACIL) PROD CODE #F-107
4248 I II 7/20/1981 ICI AMERICAS INC SDM 37 (ETHYL ALCOHOL-NITROGLY DRUG
MIXTURE)
4249 I III 6/19/1981 POLYMER CORP POLYBOND ADHES. SYSTEMS IN THE PF-SERIES
Page 121
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4268 I II 7/16/1981 PROCESSING CO INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PARAMOUNT CALIFORNIA.
4269 I II 8/31/1981 ROEHR CHEMICALS INC PHENYLPROPANOLAMINE BASE
4270 I II 9/1/1981 DANISCO INGREDIENTS MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN GRINSTED, DENMARK.
4271 I II 9/10/1981 FH FAULDING AND CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
4272 I II 8/25/1981 RHONE POULENC INC SURICLONE (31, 264 R.P.)
4273 A II 7/15/1981 BAYER AG TRASYLOL (APROTININ)-DRUG SUBSTANCE
4274 I II 9/2/1981 PLANTEX LTD CHEMICAL AND HYDRALAZINE HCL U.S.P.
PHARMACEUTICAL WORKS
4275 I II 8/21/1981 KV PHARMACEUTICAL CO MEDIGESIC PLUS CAPS
4276 I II 9/23/1981 INDUSTRIA FARMACEUTICA SERONO MANUFACTURING SITE, FACILITIES,
SPA PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
4277 I II 9/8/1981 NV ORGANON TESTOSTERONE PROPIONATE
4278 I II 9/17/1981 SIGMA F AND D DIV LTD GLUTATHIONE, FREE ACID REDUCED FORM
4279 I II 9/23/1981 ROUSSELL UCLAF PREDNISOLONE SUCCINATE (PREDNISOLONE
HYDROGEN SUCCINATE)
4280 I II 9/22/1981 GANES CHEMICALS INC PENNSVILLE DISOPYRAMIDE PHOSPHATE,BULK FORM
4281 I II 9/23/1981 INDUSTRIA FARMACEUTICA SERONO HUMAN CHORIONIC gonadotropin (HCG)
SPA
4282 I II 9/10/1981 JT BAKER CHEMICAL CO CHLOROPROCAINE HCL
4283 I II 8/31/1981 SCHERING AG FACILITIES FOR THE G OF LIQUID & SOFT
GELATIN CAPSULE PRODUCTS
4284 I II 10/8/1981 FOREST LABORATORIES INC SODIUM FLUORIDE 22MG, SUSTAINED ACTION
CAPSULES
4285 I II 10/2/1981 COMPANIA ESPANOLA DE SINTESIS DEXAMETHASONE BASE, USP XX
QUIMICA SA
4286 I III 9/9/1981 DEXTER CORP COATINGS IN 8500-A--AND 8510-A SERIES
4287 A II 10/2/1981 MERCK KGAA PRAZIQUANTEL 2-(CYCLOHEXYLCARBONYL)-
1,2,3,6,7,11BETA-4HPYRAZINO-(2,1-ALPHA)
4288 I II 10/4/1981 SIFAVITOR SRL PROPRANOLOL HCL
4289 I II 9/29/1981 LEK PHARMACEUTICAL AND CHEMICAL CALCIUM (GLUCOHYTONATE) GLUCEPTATE
CO DD
4290 I II 10/8/1981 LUSOCHIMICA SPA OXYMETAZOLINE HCL USP XX
4291 I II 9/25/1981 TEVA PHARMACEUTICAL INDUSTRIES SULFAMETHOXAZOLE
LTD
4292 I II 10/21/1981 BIOCRAFT LABORATORIES INC FOR NON-PENICILLIN PRODS FACILS AT BANK
STREET LOCATION
4293 I II 9/29/1981 LEK PHARMACEUTICAL AND CHEMICAL LITHIUM CARBONATE
CO DD
Page 122
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4294 I II 9/29/1981 SOCIETA ITALIANA CORTICOSTEROIDI BETAMETHASONE NA PHOSPHATE
SPA
4295 I II 10/19/1981 HUHTAMAKI OY LEIRAS DISOPYRAMIDE PHOSPHATE BULK FORM
PHARMACEUTICALS
4296 I II 8/28/1981 ORGANICHEM CORP SUPROFEN
4297 A II 9/29/1981 LEK PHARMACEUTICALS DD SILVER SULFADIAZINE
4298 I II 10/22/1981 SCHERING PLOUGH AVONDALE CO DEXCHLORPHENIRAMINE MALEATE
4299 I I 10/7/1981 FLOW LABORATORIES INC SOP FOR STORAGE & DISTRIB. OF CLINICAL
DRUGS-MCLEAN,VA.-(NCI CONTRACT)
4300 I II 8/14/1981 ABBOTT LABORATORIES SPEC, STANDARD CONTROL PROCEDS & TEXT
PHARMACEUTICAL PRODUCTS DIV METHODS FOR INA INGREDS.
4301 I II 10/27/1981 A INC MANUF OF MICROSPOROUS MEMBRANE FLAT
STOCK PRODUCTS FOR PHARM USE
4302 I II 10/19/1981 ACIC LTD PROCEDURES FOR THE MANUF OF
PROCHLORPERAZINE EDISYLATE
4303 I II 9/29/1981 LEK PHARMACEUTICAL AND CHEMICAL FDA DATA AND REFERENCE MATERIAL:
CO DD HISTORICAL CONTROL FOR EPILEPSY
MONOTHERAPY CLINICAL TRIALS
4304 I II 9/24/1981 ACF CHEMIEFARMA NV SULFAMETHOXAZOLE USP XX
4305 A II 10/22/1981 SCHERING PLOUGH AVONDALE CO CHLORPHENIRAMINE MALEATE
4306 I III 10/5/1981 ALUMINUM CO AMERICA SPECIFS FOR ALCOA CLOSURE STRUCTURES
IN THE 6000 SERIES
4307 I II 10/19/1981 ACIC LTD PROCEDURES FOR THE MANUF OF
ALLOPURINOL
4308 I II 8/28/1981 SCHERING AG MEGLUMINE (D(-) N- METHYLGLUIAMINE)
4309 I II 10/23/1981 SIGMA F AND D DIV LTD N-(2-MERCAPTOPROPIONYL) GLYCINE
4310 I II 9/30/1981 AMERICAN PLASTICS CO INC PERSONNEL FACILS & GEN OPER PROCEDS -
INDEPENDENCE MISSOURI LOCATION
4311 I II 10/19/1981 ACIC LTD PROCEDURES FOR
4312 A II 10/21/1981 SCHERING PLOUGH AVONDALE CO DEXBROMPHENIRAMINE MALEATE
4313 A II 11/3/1981 COPPERHEAD INVESTMENTS INC SDM 27 (10% NITROGLYCERIN IN PROPYLENE
GLYCOL)
4314 I II 11/9/1981 AZIENDE CHIMICHE RIUNITE ANGELINI LONIDAMINE
FRANCESCO SPA
4315 I II 10/19/1981 ACIC LTD PROCEDURES FOR THE
4316 I V 11/6/1981 TOXICOL SISA INC PRROGENICITY TESTING OF THALLOUS
CHLORIDE T1-201 INJECT
4317 I II 10/15/1981 SCHERING PHARMACEUTICAL CORP BETAMETHASONE USP
4318 I I 11/5/1981 ISP FACILITY FOR BULK PHARMS.
4319 I II 10/19/1981 ACIC LTD PROCEDURES FOR THE
4320 I I 11/10/1981 SHERWIN WILLIAMS CO 4-ETHYL-2-NITROPHEND
4321 I II 10/19/1981 ACIC LTD PROCEDURES FOR
4322 I II 10/8/1981 SUNEETA LABORATORIES LTD PROBENECID USPXX
4323 A II 11/10/1981 ALBEMARLE CORP LIDOCAINE HCL, USP, BP & PH EUR
4324 I II 10/1/1981 SIGMA F AND D DIV LTD 5-BROMO-2'-DEOXYURIDINE
Page 123
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4325 I II 10/19/1981 ACIC LTD CHLOROTHIAZIDE PROCEDURES FOR
4326 I II 9/2/1981 FLESSEN PLASTIC INC PERSONNEL, FACILS & GEN OPER PROCEDS AT
THE GREENVILLE, N.C. LOCATION
4327 I II 11/10/1981 PHARMACIA AND UPJOHN AT THE CHRISTIANSTED, ST. CROIX LOCATION
4328 A II 10/2/1981 PROCOS SPA PHENELZINE SULFATE
4329 I II 10/19/1981 ACIC LTD PROCEDURES FOR THE MANUF OF IBUPROFEN
Page 124
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4356 I I 10/15/1981 LABOCHIM MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
4357 I III 11/20/1981 ALZA CORP ALZAMER BIOERODIBLE POLYMERIC
MATERIALS--PRODUCED IN THE PALO ALTO CA.
Page 125
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4385 I II 11/6/1981 SANDOZ LTD PHARMACEUTICAL DIV ETOPOSIDE (VP 16-213) (ETHYLIDENE)
CHEMICAL DEVELOPMENT
4386 I II 6/25/1982 FABBRICA ITALIANA SINTETICI SPA QUAZEPAM--BULK DRUG
4387 I II 11/23/1981 LONZA INC CHORHEXIDINE DIACETATE BP 73
4388 I II 11/25/1981 GRINDSTED PRODUCTS PYRIDOXINE HYDROCHLORIDE
4389 I II 12/17/1981 DIOSYNTH BV VECURONIUMBROMIDE SECOND SUBMISSION
12-17-81
4390 I II 1/14/1982 ROCHE VITAMINS AND FINE CHEMICALS BETA-CAROTENE CAPS., 30MG AS PRODUCED
DIV HOFFMAN LAROCHE INC IN NUTLEY,NJ FACILITIES
4391 I II 1/5/1982 UNION CARBIDE CORP LECITHIN (BOLEC PC 80+)
4392 A III 1/14/1982 OLIVER HEALTHCARE PACKAGING HEAT SEAL LABEL MATERIAL
4393 I II 1/14/1982 LINSON LTD FLUPHENAZINE HYDROCHLORIDE, BULK FORM
4394 I II 1/18/1982 CHEMI SPA INDOMETHACINE USP XX
4395 A II 11/25/1981 CHEMISCHE FABRIK BERG GMBH BUTALBITAL
4396 I II 12/24/1981 VIS FARMACEUTICA METHYLCLOTHIAZIDE
4397 I II 12/22/1981 HOVIONE FARMACIENCIA SA BETAMETHASONE 17-VALERATE
4398 I II 12/15/1981 KV PHARMACEUTICAL CO KETOPROFEN S.R. CAPS., 150MG & 200MG
4399 I II 12/18/1981 WYCKOFF CHEMICAL CO INC DIPHENHYDRAMINE HCL USP XX
4400 I II 12/24/1981 NAPP CHEMICALS INC SULFACETAMIDE
4401 I II 11/25/1981 GRINDSTED PRODUCTS SULFAMERAZINE
4402 I II 12/23/1981 LONZA RIVERSIDE HYDROXYAMPHETAMINE HYDROBROMIDE
4403 I II 12/22/1981 DM GRAHAM LABORATORIES INC ISORBIDE DINITRATE C.R. CAPS 80MG
4404 I II 1/12/1982 KV PHARMACEUTICAL CO NICOTINIC ACID CAPSULES 125,250, & 500MG
4405 I II 12/21/1981 MALLINCKRODT INC MANUFACTURING SITE, FACILITIES,
PERSONNEL AND GENERAL OPERATING
PROCEDURES IN PETTEN, HOLLAND FACILITY.
4406 I II 1/15/1982 SCHERING AG NANDROLONE PHENPROPIONATE,17 B-(3-
PHENYLPROPIONYLOXY-)4-ESTREN-3-ONE
4407 I II 11/25/1981 BASF HEALTH AND NUTRITION AS RIBOFLAVINE
4408 I II 1/15/1982 LINSON LTD FLUMETHIAZIDE
4409 I I 1/18/1982 ORGANON OSS MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
4410 I II 1/7/1982 HOECHST AG GONADORELIN BULK DRY SUBSTANCE
4411 I II 1/22/1982 POLYSCIENCES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURE IN WARRINGTON, PA.
4412 I II 12/18/1981 KV PHARMACEUTICAL CO HEXASTAT CAPS, 50 & 100MG
4413 I II 1/11/1982 TROPONWERKE GMBH CO KG CROTAMITON
4414 I II 12/21/1981 GRINDSTED PRODUCTS SULFAMERAZINE SODIUM
4415 I II 1/20/1982 HOECHST CELANESE CORP DOPAMINE HCL, BULK DRUG SUBSTANCE
4416 A II 1/23/1982 OLON SPA CARISOPRODOL
4417 I II 1/27/1982 NATIONAL CANCER INSTITUTE SANGIVAMYCIN HCL (NSC 143648) AS
PREPARED BY THE FREDERICK CANCER RES.
4418 I II 1/11/1982 E MERCK PRODUCT 502006, VITAMIN K PHYTONADIONE
Page 126
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4419 I II 12/21/1981 GRINDSTED PRODUCTS SULFAMETHAZINE SODIUM
4420 A II 2/3/1982 TEVA PHARMACEUTICAL INDUSTRIES DESONIDE
LTD
4421 I II 2/1/1982 SMITH KLINE & FRENCH LABS DIV DIPHENIDOL HCL
SMITHKLINE BECKMAN CORP
4422 I II 2/1/1982 SWORDS LABORATORIES LTD TRIFLUPROMAZINE & TRIFLUPROMAZINE HCL
4423 A II 2/3/1982 SANOFI CHIMIE FLUOROMETHOLONE
4424 I II 1/29/1982 PHARMACEUTICAL RESEARCH MANUFACTURING SITE, FACILITIES,
INSTITUTE PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN WORTHINGTON, OHIO.
4425 I II 1/20/1982 SOCIETA ITALIANA MEDICINALI DISOPYRAMIDE PHOSPHATE
SCANDICCI SIMS SRL
4426 I II 12/21/1981 NORAMCO INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ATHENS, GEORGIA.
4427 I III 10/19/1981 VALSPAR CORP LAMINATING ADHESIVES AS PRODUCED IN THE
ILLNOIS FACILITIES
4428 I III 12/22/1981 FGC ACQUISITION COMPANY LLC CLOSURES FOR USE IN PACKAGING OF
PHARMACEUTICAL PRODUCTS
4429 I I 1/25/1982 YAMANOUCHI PHARMACEUTICAL MANUFACTURING SITE, FACILITIES,
COMPANY LTD PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
4430 I II 2/3/1982 LONZA INC FLAVOXATE HYDROCHLORIDE
4431 I II 1/21/1982 RECORDATI INDUSTRIA CHIMICA E BROMODIPHENHYDRAMINE hcl bulk
FARMACEUTICA SPA
4432 I III 1/27/1982 HELVOET PHARMA NV RUBBER COMPOUNDS: CODE FM 157 & RL 5-54-
1
4433 I II 12/21/1981 NORAMCO INC ZOMEPIRAC SODIUM DIHYRATE
4434 I II 2/17/1982 ABBOTT LABORATORIES SODIUM THIAMYLAL
PHARMACEUTICAL PRODUCTS DIV
4435 A II 1/29/1982 COSMA SPA HYDROXYZINE HYDROCHLORIDE
4436 I II 2/4/1982 SMITH KLINE & FRENCH LABS DIV HYDROCHLOROTHIAZIDE IN PHIL PA
SMITHKLINE BECKMAN CORP
4437 I II 1/25/1982 MONSANTO CO EMA
4438 A II 2/18/1982 CAMBREX PROFARMACO MILANO SRL OXAZEPAM
4439 I II 4/14/1981 BENE PHARMACHEM GMBH AND CO KG PENTOSAN POLYSULFATE SP54
4440 I II 2/18/1982 BLASCHIM SPA IBUPROFEN
4441 I II 12/21/1981 NORAMCO INC TOLMETIN SODIUM DIHYDRATE
4442 I II 2/18/1982 ACIC LTD CHLORPROMAZINE HCL--ACIC PROCEDURES
FOR THE MANUF.
4443 I II 2/5/1982 DAIICHI SANKYO CO LTD CETRAXATE HYDROCHLORIDE
4444 I II 6/22/1982 SANOFI INC AMIODARONE HCL
4445 I III 2/2/1982 HELVOET PHARMA ITALIA SPA BLACK CHLOROBUTYL RUBBER STOPPERS S
450/60
Page 127
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4446 I II 2/10/1982 FARMA FOOD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BIRKEROED, DENMARK.
4447 I II 2/5/1982 AJINOMOTO CO INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF CRYSTALLINE AMINO ACIDS
IN RALEIGH, NORTH CAROLINA.
4448 I II 2/5/1982 DAIICHI SANKYO CO LTD CETRAXATE HCl CAPSULES
4449 I II 2/11/1982 PHARMICHEM TESTING SERVICES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN TINLEY PARK, ILLINOIS.
4450 I II 3/3/1982 LILLY RESEARCH LABORATORIES DIV PROTAMINE S04
ELI LILLY AND CO
4451 I I 2/25/1982 SIGMA F AND D DIV LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
4452 I IV 3/4/1982 NAARDEN INTERNATIONAL USA INC FRAGRANCES: 1. FRAGRANCE N-7043
4453 I II 2/12/1982 ISF ISF 2469 (CADRALAZINE)
4454 I III 6/29/1981 REXENE CORP POLYPROPYLENE RESINS IN THE PP 23M
SERIES
4455 I II 3/4/1982 SIGMA F AND D DIV LTD TYRAMINE HYDROCHLORIDE
4456 I II 2/22/1982 SMITH KLINE AND FRENCH ISOPROPAMIDE IODIDE
LABORATORIES
4457 I II 2/8/1982 ORGAMOL SA ORPHENADRINE CITRATE/ORPHENADRINE HCL
(TRANSFER TO D 4811 1/13/88)
4458 I II 2/24/1982 LEK PHARMACEUTICAL AND CHEMICAL PROPRANOLOL HCL
CO DD
4459 I II 3/3/1982 SIGMA F AND D DIV LTD DL-6-METHYL-5,6,7,8-TETRAHYDROPTERINE
4460 I II 3/11/1982 CYCLO PRODUCTS INC THIORIDAZINE hcl
4461 I II 2/25/1982 LABORATOIRES SERONO SA PROFASI (hCG) HUMAN CHORIONIC
gonadotropin)
4462 I I 3/8/1982 H FINZELBERGS NACHFOLGER CASANTHRANOL --FACILITIES
(MANUFACTURING)
4463 I II 2/24/1982 BASF AKTIENGESELLSCHAFT 7,-8-DIDEHYDRO-RETINOIC ACID
4464 A IV 3/5/1982 GATTEFOSSE SAS LABRAFIL M 1944 CS
4465 I I 3/18/1982 CENTRAL PHARMACEUTICALS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SEYMOUR, IND.
4466 I II 3/17/1982 LONZA INC CARSONON L-4
4467 I I 5/19/1985 LABORATOIRES SERONO SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN AUBONNE, SWITZERLAND
(FORMERLY 4473 AND 4547).
4468 I II 1/25/1982 TAKEDA CHEMICAL INDUSTRIES LTD PHARMACEUTICAL PROCESSING OF
CEFMENOXINE HCL FOR INJECT -HIKARI PLANT
Page 128
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4469 I II 2/25/1982 FERROSAN AB MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES
4470 I II 3/10/1982 QUINTILES SCOTLAND LTD FOR THE SYNTEX RES. CTR. IN RICCARTON,
EDINBURGH, SCOTLAND
4471 I II 3/8/1982 H FINZELBERGS NACHFOLGER CASANTHRANOL
4472 I II 3/17/1982 LONZA INC CARSONON L-23
4473 I I 3/10/1982 LABORATOIRES SERONO SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES
4474 I II 3/18/1982 SIGMA F AND D DIV LTD GLUCOSIDASE
4475 A II 3/12/1982 DELMAR CHEMICALS INC ESMOLOL HYDROCHLORIDE
4476 I II 1/25/1982 TAKEDA CHEMICAL INDUSTRIES LTD TAP-144 LEUPROLIDE BULK PRODUCTION IN
CENTRAL RESEARCH DIVISION
4477 I IV 2/25/1982 WP DEVELOPMENT AB MULTIPOR COATING POLYMER
4478 I II 3/10/1982 LABORATOIRES SERONO SA ASELLACRIN (SOMATROPIN)
4479 I II 3/24/1982 SIGMA F AND D DIV LTD ANGIOTENSIN I
4480 I II 3/19/1982 MEIJI SEIKA KAISHA LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN GIFU PLANT, JAPAN.
4481 I III 3/18/1982 WAITAKI INTERNATIONAL BIOSCIENCES POLYVINYL ACETATE PHTHALATE(PVAP)
SUB WAITAKI CANADA LTD
4482 I II 1/15/1982 SCHERING AG NANDROLONE PHENPROPIONATE
4483 I II 3/11/1982 INDUSTRIA FARMACEUTICA SERONO PURE URINARY FSH ALSO REFERRED TO AS
SPA UROFOLLITROPHIN AND PERGONAL FSH
4484 I III 2/3/1982 SOLVAY AND CIE SA HD-PE HOMOPOLYMER ELTEX A 1050 P
4485 I II 3/19/1982 MEIJI SEIKA KAISHA LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN OSAKA CITY, JAPAN.
4486 A II 4/5/1982 TEVA PHARMACEUTICAL INDUSTRIES FLUOCINOLONE ACETONIDE (PROCESS I)
LTD
4487 I III 4/2/1982 TRAVENOL LABORATORIES INC PROD. OF FROZEN PARENTERAL INJECTS IN
PLASTIC CONTAINERS
4488 I II 4/5/1982 LABORATORIOS JULIAN DE MEXICO SA HYDROCHLOROTHIAZIDE
4489 I II 2/2/1982 DIOSYNTH BV HYALURONIDASE
4490 I II 4/2/1982 LYPHOMED INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ORLANDO, FLORIDA.
4491 I II 3/29/1982 WYCKOFF CHEMICAL CO INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SOUTH HAVEN, MICHIGAN.
4492 I II 4/6/1982 SIGMA F AND D DIV LTD BIOA PEPTIDES (FORMERLY SOMATOSTATIN)
4493 A II 4/5/1982 SOCIETA ITALIANA MEDICINALI CLONIDINE HCL
SCANDICCI SIMS SRL
Page 129
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4494 I II 3/10/1982 SMITH KLINE & FRENCH LABS DIV DOXEPIN HCL
SMITHKLINE BECKMAN CORP
4495 I II 2/25/1982 LABORATORIE GUERBET IOXAGLIC ACID
4496 I II 4/6/1982 MY K LABORATORIES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SKOKIE, ILL.
4497 I II 3/15/1982 COMPANIA ESPANOLA DE SINTESIS DEXAMETHASONE SODIUM PHOSPHATE USP XX
QUIMICA SA
4498 I III 3/12/1982 IMPERIAL CHEMICAL INDUSTRIES PLC MELINEX 800 AND ALKATHENE MASTERBATCH
0121 WHITE 1036
4499 I II 4/15/1982 DM GRAHAM LABORATORIES INC ACTIFED S.A. BRAND OF PSEUDOEPHEDRINE
HCL 120MG & TRIPTOLIDINE 5MG
4500 I I 3/25/1982 MCNEIL PHARMACEUTICAL DIV MANUFACTURING SITE, FACILITIES,
MCNEILAB INC PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SPRING HOUSE,
PENNSYLVANIA.
4501 I III 3/10/1982 BP CHEMICALS LTD RIGIDEX HPDE POLYMERS
4502 A III 2/17/1982 EI DUPONT DE NEMOURS CO DUPONT BYNEL® ADHESIVE RESINS ELVAX® EV A
PACKAGING AND INDUSTRIAL RESINS
POLYMERS
4503 I III 2/18/1982 JOHNSON LAMINATING AND COATING LAMINATED PACKAGING MATERIALS
INC
4504 I II 3/18/1982 SOCIETE SUISSE DES EXPLOSIFS NITROGLYCERIN,PENTAERYTHRITOL
TETRANITRATE AND ISOSORBIDE DINITRATE
4505 A II 4/26/1982 ALBEMARLE CORP PARA-AMINOHIPPURIC ACID USP XX
4506 I II 3/18/1982 TAKEDA CHEMICAL INDUSTRIES LTD PYRIDOXINE HYDROCHLORIDE
4507 I II 4/14/1982 ELANCO SA BENOXAPROFEN TECHNICAL
4508 I II 4/6/1982 ABBOTT LABORATORIES HYDROCHLOROTHIAZIDE
PHARMACEUTICAL PRODUCTS DIV
4509 I II 4/4/1982 KALI CHEMIE PHARMACEUTICA GMBH (PILOT PLANT)
4510 I II 4/19/1982 DIOSYNTH BV METHDILAZINE
4511 I II 4/20/1982 HYGENIC CORP FOR NATURAL LATEX SHEETING-
4512 I II 4/23/1982 ROUSSELL UCLAF TESTOSTERONE (DIOSYNTH BV)
4513 I II 3/29/1982 SANDOZ LTD PHARMACEUTICAL DIV DIBENZOSUBERONE
CHEMICAL DEVELOPMENT
4514 A II 4/16/1982 COSMA SPA HYDROXYZINE PAMOATE
4515 I II 5/7/1982 MALLINCKRODT INC COMPAP (TM)
4516 I II 5/4/1982 SCHERING AG 6a-METHYLPREDNISOLONE-21-ACETATE
4517 A II 5/4/1982 CAMBREX PROFARMACO MILANO SRL LORAZEPAM
4518 I IV 5/17/1982 KABI PHARMACIA HEPAR INC EGG YOLK PHOSPHATIDE
4519 A II 4/30/1982 ABBVIE INC PRAMOXINE HCL
4520 I II 4/26/1982 DUPHAR BV MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN OLST, THE NETHERLANDS.
4521 I II 4/7/1982 SIGMA F AND D DIV LTD ALPHA-LINOLENIC ACID
Page 130
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4522 I II 3/12/1982 SPECTOR MOLDING INC FACILITIES AND GENERAL OPERATING
PROCEDS
4523 A II 5/3/1982 COSMA SPA METOCLOPRAMIDE HYDROCHLORIDE
4524 A II 5/10/1982 PHARMACIA AND UPJOHN CO LLC DEXAMETHASONE USP MICRONIZED
WHOLLY OWNED SUB OF PFIZER INC
4525 A II 4/20/1982 AMRI RENSSELAER INC MEPERIDINE HCL USP
4526 I II 4/20/1982 DIOSYNTH BV METHANDRIOL DIPROPIONATE
4527 I II 4/26/1982 DUPHAR BV YUTOPAR (RITODRINE HCL) TABLETS &
INJECTION FORMS,OLST,HOLLAND
4528 I III 5/11/1982 ABBOTT LABORATORIES HOSP SPECS FOR CONTAINER & CLOSURE USED IN
PRODUCTS DIV MANUF OF SVP & LVP PRODUCTS
4529 I II 5/5/1982 SIGMA F AND D DIV LTD d-BIOTIN
4530 I II 4/16/1982 ESP INDUSTRIES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN EDISON, NEW JERSEY.
4531 A II 4/7/1982 RECORDATI INDUSTRIA CHIMICA E PHENYTOIN MICRO
FARMACEUTICA SPA
4532 A II 5/10/1982 PHARMACIA AND UPJOHN CO LLC DEXAMETHASONE ACETATE USP ANHYDROUS
WHOLLY OWNED SUB OF PFIZER INC MICRONIZED
4533 I II 4/9/1982 MAR KAY PLASTICS INC PERSONNEL, FACILITIES AND GENERAL
OPERATING PROCEDURES
4534 I II 5/7/1982 SCHERING AG 6-METHYLPREDNISOLONE-21-HEMISUCCINATE
4535 I II 5/7/1982 ABBVIE INC CLORAZEPATE DIPOTASSIUM (TRANXENE)
4536 I V 5/14/1982 AMERICAN PHARMACEUTICAL STERILE PROCESSING FACILITY IN MELROSE
PARTNERS INC PARK, IL
4537 I II 4/7/1982 DIPHARMA FRANCIS SPA HYDROFLUMETHIAZIDE USP
4538 A II 4/7/1982 RECORDATI INDUSTRIA CHIMICA E PHENYTOIN SODIUM
FARMACEUTICA SPA
4539 A II 5/17/1982 R MASON CHEMICALS LTD SELENIUM DISULFIDE
4540 I II 5/18/1982 SIGMA F AND D DIV LTD DIETHYLENETRIAMINEPENTAACETIC ACID
(CLINICAL STUDY BY D.HONEYCHURCH)
4541 A III 4/20/1982 AMERICAN PACKAGING CORP PACKAGING MATERIALS
4542 I II 5/14/1982 UG CLOSURES AND PLASTICS LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF BOTTLES AND CLOSURES.
4543 I III 5/20/1982 RJR PACKAGING PUSH-THROUGH BLISTER BACKING MATERIALS
PRODUCED WINSTON-SALEM, N.C.
4544 A III 5/21/1982 SELIG SEALING PRODUCTS INC CAP LINERS
4545 I II 5/13/1982 SCHERING AG PIRAZOLAC
4546 I II 5/18/1982 SIGMA F AND D DIV LTD PYRUVIC ACID SODIUM SALT
4547 I I 5/24/1982 LABORATOIRES SERONO SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES .
4548 I II 3/18/1982 LEO PHARMACEUTICAL PRODUCTS LTD FACILS & CONTROLS USED IN GR OF SODIUM
FUSIDATE CAPS.
Page 131
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4549 I II 5/11/1982 KEY PHARMACEUTICALS INC SUB MANUFACTURING SITE, FACILITIES,
SCHERING PLOUGH CORP PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MIAMI, FLORIDA ON 176 ST.
4550 I II 4/23/1982 ABBOTT LABORATORIES QUALITY ASSURANCE OPERATIONS
PHARMACEUTICAL PRODUCTS DIV STANDARDS
4551 I II 6/7/1982 MEDIMPEX NORTHAMERICA INC OXYTOCIN
4552 I II 6/7/1982 SANDOZ LTD PHARMACEUTICAL DIV ACEPAM
CHEMICAL DEVELOPMENT
4553 I II 6/2/1982 DURHAM PHARMACEUTICALS LLC AZONE
4554 A III 6/7/1982 PHOENIX CLOSURES INC CLOSURES & LINING
4555 A II 3/17/1982 AJINOMOTO HEALTH AND NUTRITION AMINO ACIDS
NORTH AMERICA INC
4556 I IV 5/10/1982 GATTEFOSSE ESTABLISSEMENTS PRECIROL ATO 5.
4557 I II 5/25/1982 HERCULES INC PENTAERYTHRITOL TETRANITRATE DILUTED
(PETN)
4558 I II 5/25/1982 SCHERING PLOUGH INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
4559 I II 4/29/1982 AH ROBINS CO MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES .
4560 I III 4/5/1982 ST GOBAIN PERFORMANCE PLASTICS TFE/POLYETHYLENE LAMINATES
CORP
4561 A II 5/12/1982 FINE CHEMICALS CORP PTY LTD VINCRISTINE SULPHATE/VINBLASTINE
SULPHATE
4563 I II 6/18/1982 PHARMADERM DIV ALTANA INC URAPIDIL AMPULES AS PRODUCED IN THE
HICKSVILLE, NY FACILITY
4564 I II 5/14/1982 MEIJI SEIKA KAISHA LTD NEOTHRAMYCIN
4566 A III 6/9/1982 ST GOBAIN PERFORMANCE PLASTICS TFE/14B RUBBER LAMINATES
CORP
4567 I III 2/10/1982 ROLLING DIV NATIONAL ALUMINUM UNIT ALUM FOIL/PAPER LAMINATIONS AS PROD IN
NATIONAL STEEL CORP SOMERVILLE, MASS FACILITY
4568 I II 4/23/1982 PHARMA-WALDHOF GMBH URIDINE PRODUCT #3401
4569 I IV 4/28/1982 NEWMANN BUSLEE AND WOLFE INC NATURAL & ARTIFICIAL FLAVOR #390170 &
365070
4570 A II 5/21/1982 FERMION OY TRAZODONE HYDROCHLORIDE
4571 A IV 6/10/1982 HENKEL CORP DURO-TAK PRESSURE SENSITIVE ADHESIVES
4572 I III 6/9/1982 ST GOBAIN PERFORMANCE PLASTICS TFE SILICONE LAMINATES AS PROD IN THE
CORP WAYNE, NJ PLANT
4573 I II 5/4/1982 PHARMA-WALDHOF GMBH ADENOSINE-5-MONOPHOSPHORIC ACID,
PRODUCT #2030
4574 I II 6/2/1982 ICI AMERICAS INC G-100 DIMETHYL ISOSORBIDE/ANIMAL STUDIES-
IN VITRO BLOOD COMPAT TESTS
4575 I II 4/29/1982 CIECH POLFA SULFAQUINOXALINE
4576 I II 4/21/1982 CILAG CHEMIE AG SUPROFEN
Page 132
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4577 I II 4/30/1982 MEIJI SEIKA KAISHA LTD NEOTHRAMYCIN, BULK
4578 I II 6/9/1982 GLAXOCHEM LTD BETAMETHASONE VALERATE
4579 I II 5/24/1982 LABORATOIRES SERONO SA STILAMIN (SOMATOSTIN)
4580 I II 6/3/1982 MD PHARMACEUTICAL INC DIPHENOXYLATE HCL W/1% ATROPINE SULFATE
SUBSTANCE
4581 I IV 6/4/1982 AH ROBINS CO PLACEBO TABLET MATCHING PONDIMIN
EXTENTAB
4582 I III 6/11/1982 A INC MICROPOROUS MEMBRANE CARTRIDGE FOR
PHARM USE
4583 I II 6/15/1982 CIBA GEIGY CORP PHARMACEUTICAL ANAFRANIL INJECTABLE (CLOMIPRAMINE HCl)
DIVISION
4584 I II 5/14/1982 FARMABOIS NANDROLONE-17-DECANOATE USP XX
4585 I II 5/25/1982 ACIC LTD CHENODEOXYCHOLIC ACID
4586 I II 5/19/1982 STAROGAREZKIE ZAKLADY TOLBUTAMIDE
FARMACEUTYCZNE POLFA
4587 I II 6/14/1982 SCHERING AG 6-METHYLPREDNISOLNE
4588 I II 4/23/1982 GREEN CROSS CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN YODOGAWA.
4589 I II 7/7/1982 CONNAUGHT LABORATORIES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SWIFTWATER, PA.
4590 I II 7/8/1982 MICRO BIO TESTING AND RESEARCH MANUFACTURING SITE, FACILITIES,
LABORATORIES PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN NORTH HOLLYWOOD, CA.
4591 A II 7/9/1982 TEVA PHARMACEUTICAL INDUSTRIES FLUOCINONIDE
LTD
4592 I II 7/9/1982 GLAXO WELLCOME INC CEPHALOSPORINS FILLING UNIT IN EVREUX,
FRANCE
4593 I II 7/7/1982 LEO PHARMACEUTICAL PRODUCTS LTD PERSONNEL, FACILITIES AND GENERAL
OPERATING PROCEDURES
4594 I II 5/17/1982 INDUSTRIA CHEMICA PRODOTTI IBUPROFEN USP
FRANCIS SPA
4595 I II 6/14/1982 DIOSYNTH BV NALOXONE HYDROCHLORIDE
4596 I II 6/17/1982 GANES CHEMICALS INC PENNSVILLE SULFINPYRAZONE
4597 I II 6/16/1982 SCHERING AG PREDNISOLONE-21-ACETATE
4598 I II 6/11/1982 APPLIED ANALYTICAL INDUSTRIES INC FACILITIES & INSTRUMENTATION
4599 I II 6/16/1982 CIBA GEIGY CORP PHARMACEUTICAL RITALIN
DIVISION
4600 I II 6/21/1982 MD PHARMACEUTICAL INC TRIPROLIDINE HCL MONOHYDRATE
4601 I II 6/23/1982 BIDACHEM SPA CHLORTHALIDONE U.S.P.
4602 I II 7/15/1982 BANNER GELATIN PRODUCTS CORP FACILS/PERSONNEL/GOP FOR THE OLDS,
ALBERTA PLANT
4603 I II 7/2/1982 FREEDOM CHEMICAL DIAMALT GMBH CHENODEOXYCHOLIC acid
Page 133
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4604 I II 7/18/1982 COMPANIA ESPANOLA DE SINTESIS PREDNISOLONE SODIUM PHOSPHATE, USP XX
QUIMICA SA
4605 I II 6/15/1982 OCE ANDENO BV PROLINE THIOESTER
4606 I I 6/29/1982 HARRIS LABORATORIES INC PERSONNEL,FACIL.FLOOR PLANS & EQUIP. LIST
FOR LABS & CLINIC-LINCOLN,NE
4607 I II 7/23/1982 PFIZER INC FLUOXYMESTERONE USP
4608 I II 7/14/1982 ORION CORP LTD THIORIDAZINE HYDROCHLORIDE
4609 I II 7/13/1982 SCHERING PHARMACEUTICAL CORP FACIL, PERSONNEL & GEN OPERATING
PROCEDS FOR MANATI, PR PLANT
4610 I II 6/16/1982 PLIVA PHARMACEUTICAL CHEMICAL CHLOROTHIAZIDE
FOOD & COSMETIC INDUSTRY
4611 I II 6/17/1982 PT RIASIMA ABADI INDUSTRI KIMIA ACETAMINOPHEN
FARMASI PERTAMA
4612 I II 2/16/1982 BAYER CORP PARACETAMOL
4613 I II 6/24/1982 SIBEFAT SPA FACILITIES, PERSONNEL AND GENERAL
OPERATING PROCEDURES
4614 I III 6/15/1982 STALCON PLASTICS LTD PLASTICS BOTTLES
4615 I II 7/22/1982 KNOLL AG LUDWIGSHAFEN DIMENHYDRINATE
4616 I II 7/12/1982 TAKEDA CHEMICAL INDUSTRIES LTD MANUF OF CEFMENOXIME HCL IN THE HIKARI
PLANT
4617 I II 7/7/1982 PHARMACIA INFUSION AB MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN FYRISLUND.
4618 I II 8/6/1982 HOECHST-ROUSSEL PENBUTOLOL SULFATE (BULK FORM)
PHARMACEUTICALS INC
4619 I II 8/2/1982 DIOSYNTH BV METHANDRIOL
4620 I III 8/3/1982 ABBOTT LABORATORIES FC81 FLEXIBLE,CONTAINER-PRODUCED IN
PHARMACEUTICAL PRODUCTS DIV NORTH CHICAGO, ILL. FACILITIES
4621 I II 8/9/1982 SIGMA F AND D DIV LTD METHIONINE ENKEPHALIN-ACETATE SALT
4622 I II 8/11/1982 CHEMI SPA HYDROXYZINE HCL.USP. XX 093082
4623 I II 6/10/1982 TARO PHARMACEUTICALS INC FACIL & GEN OPER PROCEDS AT DOWNSVIEW,
ONTARIO, CANADA LOCATION
4624 I II 7/27/1982 FOREST LABORATORIES INC THIORIDAZINE HCL100MG CR(LD IN SYCHRON
VEHICLE)MNFG INWOOD,NY
4625 I II 7/13/1982 ABBOTT LABORATORIES METHYCLOTHIAZIDE
PHARMACEUTICAL PRODUCTS DIV
4626 I II 7/30/1982 YUKI GOSEI KOGYO CO LTD PROTAMINE SULFATE
4627 A II 7/13/1982 RECORDATI INDUSTRIA CHIMICA E DIMENHYDRINATE
FARMACEUTICA SPA
4628 I II 8/11/1982 SIGMA F AND D DIV LTD POLY (ALA,GLU,LYS-HBR,TYR) 6:2:5:1
4629 I II 8/11/1982 CHEMI SPA HYDROXYZINE PAMOATE USP. XX
4630 I II 7/13/1982 ABBOTT LABORATORIES SPECTINOMYCIN DIHDROCHLORIDE
PHARMACEUTICAL PRODUCTS DIV PENTAHYDRATE
Page 134
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4631 I II 7/22/1982 PHARMAFAIR INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING IN
HAUPPAUGE, NEW YORK.
4632 I II 7/27/1982 FOREST LABORATORIES INC THIORIDAZINE HCl C.R. TABLETS (IN SYNCHRON
VEHICLE)
4633 A II 7/28/1982 SHANDONG XINHUA PHARMACEUTICAL THEOPHYLLINE
CO LTD
4634 I II 8/24/1982 SOCIETA ITALIANA CORTICOSTEROIDI METHYLPREDNISOLONE ACETATE
SPA
4635 I II 8/10/1982 NORTH EAST SIXTH PHARMACEUTICAL SULFAMETHOXAZOLE USP 20
FACTORY
4636 I I 7/29/1982 CADEMA MEDICAL PRODUCTS INC PERS, FACIL & GEN OP PROC/PRODUC-
ANTIMONY TRISULFIDE COLLOID KIT
4637 I II 8/13/1982 HOECHST AG SECRETIN PENTAHYDROCHLORIDE, BULK
FORM
4638 I II 8/18/1982 WARNER LAMBERT CO G, PROCESS & PACK OF INDS IN MORRIS
PHARMACEUTICAL RESEARCH DIV PLAINS, NJ FACIL (710 TABOR RD)
4639 I II 7/12/1982 BECKMAN INSTRUMENTS INC DIV D-NA 16 LUTENINIZING HORMONE RELEAS.
SMITHKLINE BECKMAN CORP HORMONE-PRODUCED BY BIOPRODUCTS
4640 I II 8/27/1982 HEALTH CHEMICAL CORP PERSONNEL, FACIL & GEN OPERATING
PROCEDS FOR EMIGSVILLE, PA PLANT
4641 I IV 8/10/1982 CIBA GEIGY CORP PHARMACEUTICAL PLACEBO FOR LITHOBID SLOW RELEASE
DIVISION TABLETS
4642 A II 9/1/1982 ALKALOIDA CHEMICAL CO ZRT PHENOBARBITAL USP
4643 I III 9/1/1982 HELVOET PHARMA MARYLAND E0608
4644 I II 9/2/1982 FOREST LABORATORIES INC IBUPROFEN 800 MG C.R. TABLETS (IN
SYNCHRON VEHICLE)
4645 I II 9/10/1982 BASF AKTIENGESELLSCHAFT LUROTIN TM CAPSULES
4646 I II 9/9/1982 STIEFEL LABORATORIES INC COMPOUND C-205
4647 I II 8/5/1982 CAMBREX PROFARMACO MILANO SRL ACETAZOLAMIDE
4648 I III 7/20/1982 CARR LOWREY DIV ANCHOR HOCKING GLASS PRODUCTS (DEFINED BY USP)
CORP
4649 A II 7/16/1982 AMINO GMBH L-TYROSINE
4650 I II 8/24/1982 SICOR SPA METHYLPREDNISOLOME HEMISUCCINATE
(FORMERLY HELD BY S.I.R.S.)
4651 I II 9/7/1982 NATIONAL CANCER INSTITUTE ELLIOTT'S B SOLUTION
4652 I II 8/10/1982 SANOFI AVENTIS CHIMIE NALOXONE HCL
4653 I II 9/13/1982 PROFARMACO SRL MICONAZOLE NITRATE & BASE
4654 I II 7/27/1982 SANOFI SYNTHELABO INC CHLORMEZANONE
4655 I II 9/15/1982 EASTMAN KODAK CO METOLAZONE (ZAROXOLYN)
4656 I II 9/15/1982 ERIMOS TECHNOLOGIES LLC NORDIHYDROGUAIARECTIC ACID (NDGA), BULK
FORM
4657 I II 9/9/1982 ABBOTT LABORATORIES VALPROIC ACID
PHARMACEUTICAL PRODUCTS DIV
Page 135
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4658 I II 9/14/1982 AYERST LABORATORIES INC DIV RAPAMYCIN (DOSAGE FORM)
AMERICAN HOME PRODUCTS CORP
4659 I II 8/24/1982 SOCIETA ITALIANA CORTICOSTEROIDI METHYLPREDNISOLONE SOD. SUCCINATE (THIS
SPA D FORMERLY HELD BY S.I.R.S)
4660 I I 9/24/1982 WESTWOOD PHARMACEUTICALS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BUFFALO, NEW YORK.
4661 I II 9/30/1982 SHIONOGI AND CO LTD CERULETIDE DIETHYLAMINE
4662 A II 9/23/1982 SANOFI CHIMIE HYDROCORTISONE VALERATE USP BULK
SUBSTANCE
4663 A IV 9/16/1982 GATTEFOSSE SAS COMPRITOL 888 PELLETS, COMPRITOL 888 ATO
Page 136
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4683 I II 10/18/1982 KV PHARMACEUTICAL CO PHENYLPROPANOLAMINE
HCl/CHLORPHENIRAMINE MALEATE S.R.(B.F.
ASCHER &CO)
4684 A II 10/13/1982 BAYER AG ESTRADIOL
4685 I II 10/14/1982 RADPHARM INC GALLIUM CHLORIDE GA-67 RADIOCHEMICAL
SOLUTION
4686 I II 10/15/1982 ORGANICHEM CORP DIATRIZOATE MEGLUMINE USP
4687 A II 10/14/1982 SUMITOMO CHEMICAL CO LTD DISOPYRAMIDE PHOSPHATE USP XX
4688 A II 10/16/1982 KONGO CHEMICAL CO LTD DEXCHLORPHENIRAMINE MALEATE
4689 I II 9/29/1982 CAMBREX PROFARMACO MILANO SRL ECONOZOLE NITRATE
4690 A II 10/13/1982 BAYER AG ESTRADIOL-3-BENZOATE
4691 A II 10/19/1982 DISHMAN NETHERLANDS BV DIHYDROTACHYSTEROL
4692 I II 10/22/1982 HOSPIRA BOULDER INC SODIUM NITROPRUSSIDE
4693 I II 10/13/1982 SANOFI SYNTHELABO INC HYDROXYCHLOROQUINE SULFATE
4694 I II 10/14/1982 INDUSTRIA CHEMICA PRODOTTI TRIMETHOBENZAMIDE HCL USP
FRANCIS SPA
4695 I II 10/14/1982 SCHERING AG TESTOSTERONE
4696 I II 10/18/1982 INDUSTRIA CHIMICA PROFARMACO SPA 2 BROMOACETAMIDO-5 CHLORO-2'
FLUOROBENZOPHENONE
4697 A II 10/27/1982 ROQUETTE FRERES DEXTROSE MONOHYDRATE USP GRADE
(LYCADEX® PF)
4698 I II 10/11/1982 HEXACHIMIE SA 2-CHLORO NICOTINIC ACID (INTERMEDIATE)
4699 I II 10/18/1982 GC SCHERER CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF HARDSHELL CAPS IN
SPRINGVILLE, UTAH.
4700 A V 11/4/1982 ELI LILLY AND CO PROCEDURES FOR STERILE OPERATIONS IN
INDIANAPOLIS, INDIANA
4701 I II 11/1/1982 DESTILERIAS ADRIAN AND KLEIN SA TERPIN HYDRATE USP XX
4702 I II 11/3/1982 OY STAR AB FACILITIES, PERSONNEL AND GENERAL
OPERATING PROCEDURES
4703 I II 10/22/1982 ER SQUIBB AND SONS INC FLUPHENAZINE HYDROCHLORIDE
4704 I II 10/25/1982 SCHERING AG METHYLTESTOSTERONE
4705 I II 11/1/1982 KV PHARMACEUTICAL CO APTROPINE SULFATE CAPSULES
4706 A II 11/2/1982 DIPHARMA FRANCIS SRL TOLAZAMIDE
4707 I II 10/26/1982 SOCIETA ITALIANA CORTICOSTEROIDI BETAMETHASONE ACETATE
SPA
4708 I I 11/9/1982 JAMES ROBINSON GMBH FACILITIES, PERSONNEL, GENERAL OPERATING
PROCEDURES-DIEBURG W GERMANY
Page 140
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4806 I III 1/17/1983 BALL CORP BALL PLASTIC 656(TM) COEXTRUD. PACKAG.
MTRLS-PRODUCED-EVANSVILLE, IND.
4807 I II 1/31/1983 3M PHARMACEUTICALS POLYURETHANE FOAM CIRCLES AS MAMUF. IN
THE ST. PAUL, MINN. FACILITIES
4808 I II 2/18/1983 INDENA GRUPPO INVERNI DELLA BEFFA DESERPIDINE USP
4809 I II 11/16/1982 FARMABOIS MEDROXYPROGESTERONE ACETATE USPXX
4810 I III 2/2/1983 BALL CORP BALL SARAN COEXTRUSIONS AS PRODUCED IN
THE EVANSVILLE, IN FACILITY
4811 I II 1/21/1983 ORGAMOL SA ORPHENADRINE CITRATE AND ORPHENADRINE
HCL.
4812 I IV 1/31/1983 3M PHARMACEUTICALS TAPE LAMINATE PATCHS
4813 A II 1/6/1983 PHARMACIA AND UPJOHN CO WHOLLY METHYLPREDNISOLONE ACETATE USP
OWNED SUB PFIZER INC
4814 I II 12/20/1982 NIPPON KAYAKU CO LTD L-ALANINE, L-METHIONINE & GLYCINE
4815 I II 8/24/1982 IRE NATIONAL INSTITUTE XENON -133 GAS
RADIOISOTOPES
4816 I II 12/22/1982 BAYER CORP NIMODIPINE CAPS 10MG (bay e 9736)
4817 I II 2/22/1983 OMNICHEM NV VERAPAMIL HCL
4818 I II 1/12/1983 MEDI PHYSICS INC 1231-M-123 OR 1231-d,1-N-ISOPROPYL-P-
IODOAMPHETAMINE HYDROCHLORIDE
4819 I II 12/6/1982 CAMBREX PROFARMACO MILANO SRL METOPROLOL TARTRATE
4820 I II 1/17/1983 OTSUKA PHARMACEUTICAL CO LTD PROCATEROL, AEROSOL FORMULATION
PRODUCED IN TOKUSHIMA FACTORY
4821 I II 9/17/1982 IRE NATIONAL INSTITUTE MOLYBDENUM-99
RADIOISOTOPES
4822 I II 12/20/1982 NIPPON KAYAKU COMPANY LTD L-THREONINE, L-TRYTOPHAN & L-ISOLEUCINE
4823 I III 3/2/1983 SIFAVITOR SRL MANUFACTURING SITE, FACILITIES, PERSONEL
& GENERAL OPERATING PROCEDURES IN
MILAN, ITALY
4824 I II 3/3/1983 PLANTEX LTD CHEMICAL AND CISPLATIN
PHARMACEUTICAL WORKS
4825 I III 3/8/1983 3M PHARMACEUTICALS HEAT SEALABLE MICROPOROUS TAPE NO. 1781
4826 I II 2/25/1983 BECKMAN INSTRUMENTS INC DIV SYNTHETIC HUMAN PROINSULIN C-PEPTIDE
SMITHKLINE BECKMAN CORP
4827 A II 3/3/1983 REGIS TECHNOLOGIES INC 4-AMINOPYRIDINE
4828 I II 2/15/1983 ORGAMOL SA METHOCARBAMOL
4829 I II 1/26/1983 SIGMA F AND D DIV LTD l ETHYL-3-(3-DIMETHYLAMINOPROPYL)
CARBODIIMIDE HCl ST. LOUIS,MO PLANT
4830 I II 1/28/1983 KNOLL AG LUDWIGSHAFEN PROPRANOLOL HCL
4831 I II 12/15/1982 SCHERING AG PREDNISOLONE
4832 I II 3/22/1983 MERCK SHARP AND DOHME RESEARCH MANUFACTURING SITE, FACILITIES,
LABORATORIES DIV MERCK AND CO INC PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN WILSON, NORTH CAROLINA.
Page 141
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4833 I II 1/11/1983 GANES CHEMICALS INC PENNSVILLE GENERAL OPERATING PROCEDS FOR
DIV PENNSVILLE, NJ FACILITY
4834 I II 2/24/1983 ERREGIERRE SPA CHENO DESOXYCHOLIC ACID
4835 I II 2/25/1983 SCM CORP ENCAPSULATED POTASSIUM CHLORIDE
DURKOTE KCL 150-92
4836 I II 3/4/1983 SIGMA F AND D DIV LTD ANTIPYRINE AS PRODUCED IN THE ST. LOUIS,
MISSOURI PLANT
4837 A III 3/10/1983 BERRY GLOBAL ARGUS-LOC & ULTRA-LOC CHILD-RESISTANT
CLOSURES
4838 I II 12/15/1982 DOW CHEMICAL CO MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MIDLAND, MICHIGAN.
4839 A II 3/11/1983 SPECGX LLC CODEINE PHOSPHATE
4840 I III 1/25/1983 PANTASOTE INC PVC COMPD AND/OR FILM: 1. 4575 PVC CMPD
AND/OR FILM
4841 I III 9/10/1982 UNION CARBIDE CORP BAKELITE BRAND POLYETHYLENE (GRSN
SERIES):1. GRSN-7144 NATURAL 7
4842 I II 3/7/1983 SIGMA F AND D DIV LTD ADENOSINE 5' TRIPHOSPHATE (ATP) DISODIUM
SALT
4843 I II 1/7/1983 SCHERING AG MICRONIZING LORMETAZEPAM
4844 I II 1/11/1983 CIS US INC MANUAFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN DEANGELO DRIVE.
4845 I II 1/4/1983 DIOSYNTH BV PROTEIN HYDROLYSATE
4846 I II 3/11/1983 SANOFI AVENTIS DEUTSCHLAND GMBH HUMAN INSULIN-SEMISYNTHETIC, BULK
MATRLS & FINISHED DOS. FORM
4847 I II 3/7/1983 NOBEL KEMI AB N,N-BIS (2,3-DIHYDROXYPROPYL)-5-
AMINOISOPHTALAMIDE OR (5-AIPA-DIAMIDE)
4848 I II 2/17/1983 AMERICAN CHEMICAL INDUSTRIAL MANUFACTURING SITE, FACILITIES,
CORP PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN RICHMOND, CALIFORNIA.
4849 I II 3/8/1983 SCHERING AG L-5-HYDROXYTRYPTOPHAN
4850 I III 3/11/1983 PERSTORP CHEMICALS AB UREA MOLDING CMPDS
4851 I IV 12/7/1982 ARCHER DANIELS MIDLAND CO SOYBEAN OIL
4852 I II 3/17/1983 LANHAM PACKAGING FACILS AND GENERAL OPERATING PROCEDS-AT
20TH & L ST., S.W., WASH, DC
4853 A III 3/28/1983 TOTAL PETROCHEMICALS AND POLYSTYRENE MANUFACTURE
REFINING USA INC
4854 I II 3/7/1983 BOFORS AB N,N'-BIS (2,3-DIHYDROXYPROPYL)-5-
NITROISOPHTALAMIDE
4855 I II 3/9/1983 SHOWA DENKO KK CHENODEOXYCHOLIC ACID-PROCEDS FOR
PRODUCTION AT THE KAWASAKI WORKS
4856 I II 2/17/1983 PHARMACIA AND UPJOHN TRANEXAMIC ACID
Page 142
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4857 I II 2/28/1983 BECTON DICKINSON MONOCLONAL MANUFACTURING SITE, FACILITIES,
CENTER INC PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MOUNTAIN VIEW, CALIFORNIA.
4858 I V 3/11/1983 SANOFI AVENTIS DEUTSCHLAND GMBH PRECLINICAL STUDIES USING HUMAN INSULIN
SEMISYNTHETIC (HOE 21 PH INJ)
4859 I II 4/8/1983 CILAG CHEMIE AG BEPRIDIL HCL
4860 I II 4/7/1983 SIGMA F AND D DIV LTD SELENO-DL-METHIONINE AS SUPPLIED BY
SIGMA (ISRAEL)CHEMICAL COMPANY
4861 I II 1/25/1983 GANES CHEMICALS INC PENNSVILLE 1-EPHEDRINE SULFATE
4862 I II 3/30/1983 PLANTEX LTD CHEMICAL AND VINCRISTINE SULFATE USP
PHARMACEUTICAL WORKS
4863 I II 3/31/1983 ASTRA RESEARCH LABORATORIES OMEPRAZOLE CAPSULES
4864 I III 3/23/1983 INEOS FILMS ITALIA SRI PVC FILM FOR PHARMACEUTICAL PACKAGING
4865 I II 12/30/1982 MEDIMPEX NORTHAMERICA INC HEPARIN SODIUM
4866 I II 3/8/1983 PEBOC LTD GUAIFENESIN USP
4867 I III 3/21/1983 TECHNICAL COATINGS CO SUB BIOEQUIVALANCE STUDY ON THREE
BENJAMIN MOORE AND CO CLOMIPHENE CITRATE PRODUCTS
4868 I III 3/16/1983 SPARTECH PLASTICS THERMOPLASTIC SHEET RTB,BTR SERIES
PRODUCED AT MEDFORD,MASS FACIL
4869 I II 11/18/1982 CELL PRODUCTS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL,AND GENERAL OPERATING IN NEW
BRUNSWICK, NEW JERSEY.
4870 I II 12/30/1982 MEDIMPEX NORTHAMERICA INC ERGONOVINE MALEATE
4871 A II 3/14/1983 TEVA PHARMACEUTICAL INDUSTRIES BECLOMETHASONE DIPROPIONATE
LTD
4872 I II 3/18/1983 ABBOTT LABORATORIES SODIUM BUTABARBITAL
PHARMACEUTICAL PRODUCTS DIV
4873 I IV 3/28/1983 MONA INDUSTRIES INC MONAMID 150-LW
4874 I III 3/16/1983 SPARTECH PLASTICS THERMOPLASTIC SHEETS FTB,BRT SERIES
MNFG MEDFORD,MASS.FACILITY
4875 I II 3/21/1983 TEMMLER WERKE VEREINIGTE KETOPROFEN CR CAPSULES 200&300MG, MNFG
CHEMISCHE FABRIKEN IN MARBURG,WEST GERMANY
4876 I II 2/24/1983 MEDIMPEX NORTHAMERICA INC TRIMETHOPRIM
4877 A II 3/26/1983 LUNDBECK PHARMACEUTICALS ITALY METOCLOPRAMIDE HCL MONOHYDRATE
SPA
4878 I II 2/21/1983 DINAMITE DIPHARMA SPA NAPROXEN USP XX BP 80
4879 I I 2/28/1983 BIOREX LABORATORIES INC MANFACTURING SITE, FACILITIES, PERSONNEL,
AND GENERAL OPERATING PROCEDURES IN
LONDON ON QUEENSLAND ROAD.
4880 I II 3/16/1983 AAI PHARMA LLC PROPOXYPHENE NAPSYLATE
4881 I II 10/14/1983 PFIZER LTD TIOCONAZOLE
4882 I II 2/1/1983 ANTIBIOTICOS SPA CHEM. & PHARMACY OF ANTIBIOTIC LM 427 AS
IT WILL BE REFERENCED BY INDS
Page 143
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4883 I II 4/4/1983 PLANTEX LTD CHEMICAL AND VINBLASTINE SO4 USP
PHARMACEUTICAL WORKS
4884 A II 3/15/1983 SPECGX LLC HYDROCODONE BITARTRATE USP CRYSTALS
4885 I II 3/1/1983 BIOREX LABORATORIES INC CICLOXOLONE SODIUM
4886 I II 3/16/1983 AAI PHARMA LLC PROPOXYPHENE HCL
4887 I II 3/23/1983 EASTMAN KODAK CO 13-Cis-RETINOIC ACID (ISOTRETINOIN)
4888 I III 3/16/1983 SPARTECH PLASTICS THERMOPLASTIC SHEET IN MTB-BTM SERIES
MNFG IN MEDFORD, MASS FACILITIES
4889 A III 3/16/1983 CONSTANTIA PATZ GES MBH ALUMINUM FOIL PACKAGING MATERIALS FOR
DRUG PRODUCTS
4890 I II 3/31/1983 JANSSEN PHARMACEUTICA NV DROPERIDOL,CODE#R4749,MNFG IN BELGIUM
AND PUERTO RICO FACILITIES
4891 I II 3/30/1983 ASTA WERKE AKTIENGESELLSCHAFT CORMELIAN COATED TABLETS
4892 I II 12/27/1982 LEDERLE LABORATORIES DIV FENBUFEN MNFG BY CYANAMID OF GREAT
AMERICAN CYANAMID CO BRITAIN, LIMITED
4893 I II 8/4/1982 NORDION INTERNATIONAL INC XENON-127 (PROD VANCOUVER, BRITISH
COLUMBIA) ORIG SUBMITTED TO D4115
4894 I II 12/20/1982 SPRET MAUCHANT LABORATORIES BAMIFYLLINE (TRENTADIL)
4895 I II 5/9/1983 TROPONWERKE GMBH CO KG ETOFENAMATE
4896 I II 5/10/1983 OMNICHEM NV PROPRANOLOL HCL
4897 I II 5/10/1983 DINAMITE DIPHARMA SPA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
4898 I II 4/2/1983 SUMIKA FINE CHEMICALS CO LTD FOLIC ACID
4899 I III 3/16/1983 SPARTECH PLASTICS COMPOSITE THERMOPLASTIC SHEETS OF
PTR,RTP SERIES,MNFG IN MEDFORD, MASS
4900 I III 7/31/1984 UNION CARBIDE CORP UCAR SOLUTION VINYL RESINS
4901 I II 3/10/1983 KONGO CHEMICAL CO LTD L- CARNITINE HYDROCHLORIDE
4902 I II 3/14/1983 FINE CHEMICALS CORP PTY LTD THIORIDAZINE HCL
4903 I III 3/16/1983 SPARTECH PLASTICS COMPOSITE THERMOPLASTIC SHEETS IN
PTF,FTP SERIES;MNFG IN MEDFORD, MASS
4904 I II 3/28/1983 AH ROBINS CO MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN RICHMOND, VIRGINIA.
4905 I II 3/23/1983 ORGAMOL SA SOBREROL
4906 I IV 4/7/1983 MING TAI CHEMICAL CO LTD MICROCRYSTALLINE CELLULOSE PROCEDURES
USE IN THE MANUFACTURING
4907 I II 4/28/1983 PITMAN-MOORE INC DIV ALLIED PERSONNEL, FACILS & GEN OPERATING
PROCEDS WASHINGTON CROSSING NJ PLANT
4908 I II 2/15/1983 PFIZER INC 5-ETHYL-2"-DEOXYURIDINE
4909 I II 3/16/1983 SIEGFRIED AG METHACHOLINE CHL
4910 I II 3/31/1983 ABBOTT LABORATORIES VERAPAMIL AS MNFG IN N.CHICAGO, ILLINOIS
4911 A II 4/18/1983 ALBEMARLE CORP PROCAINAMIDE HYDROCHLORIDE
4912 I II 4/20/1983 AYERST LABORATORIES INC DIV MYSOLINE (PRIMIDONE) TABLETS
AMERICAN HOME PRODUCTS CORP
Page 144
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4913 I II 3/31/1983 MIKART INC ATLANTA, GA. PLANT ON MARIETTA BLVD.
4914 I II 2/15/1983 PFIZER INC DECARBAZINE
4915 I II 3/4/1983 ALZA CORP OSMET DELIVERY MODULES AS PRODUCED IN
THE PALO ALTO, CA. FACILITIES
4916 I II 5/16/1983 VITARINE CO INC SUB WEST CHEMICAL PSEUDOEPHEDRINE HCL 120MG S.R. CAPS
PRODUCTS INC
4917 I II 4/18/1983 KNOLL AG LUDWIGSHAFEN AMINOPHYLLINE
4918 I II 5/10/1983 OMNICHEM NV PROPANETRIOL TRINITRATE 10% WITH
LACTOSE
4919 I II 4/25/1983 SIGMA F AND D DIV LTD TRIZMA HYDROCHLORIDE
4920 I III 2/17/1983 ER SQUIBB AND SONS INC PROCEDURES FOR PACKAGING DRUG
PRODUCTS
4921 I III 4/11/1983 FOLIENWALZWERK BRUEDER TECH ALUMINUM PACKAGING MATERIALS
AKTIENGESELLSCHAFT
4922 I II 3/17/1983 SCHERING AG DEFLAZACORT
4923 A II 4/18/1983 SIEGFRIED PHARMACHEMIKALIEN (+)-PSEUDOEPHEDRINE SULFATE
MINDEN GMBH
4924 I II 4/29/1983 CHANGZHOU PHARMACEUTICAL HYDROCHLOROTHIAZIDE
FACTORY
4925 I II 8/8/1983 HOECHST MARION ROUSSEL SA DEZOCINE
4926 I II 4/13/1983 WHITEWORTH TOWNE PAULSEN INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MONROVIA, CALIFORNIA.
4927 I II 5/24/1983 TIANJIN HEBEI PHARMACEUTICAL METRONIDAZOLE
FACTORY
4928 A II 3/22/1983 HERBRAND PHARMACHEMICALS GMBH PROPYLTHIOURACIL
4929 A II 3/17/1983 TARO PHARMACEUTICAL INDUSTRIES CARBAMAZEPINE USP
LTD
4930 I II 5/19/1983 SCHERING AG ETHINAMATE
4931 I I 4/12/1983 ELAN CORP PLC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MONKSLAND, ATHLONE.
4932 A II 6/1/1983 MINAKEM HIGH POTENT VINCRISTINE SULFATE
4933 I II 6/3/1983 ROUSSELL UCLAF TESTOSTERONE PROPIONATE
4934 I II 3/25/1983 HEXAGON LABORATORIES INC BEPRIDIL HCL
4935 I II 6/7/1983 FMC CORP CELOCAL(R) CO-PROCESSED CELLULOSE
GEL/CALCIUM SULFATE
4936 I II 6/1/1983 NORDIC SYNTHESIS AB MEPIVACAINE HCL
4937 I II 1/20/1983 DIOSYNTH BV DEXAMETHASONE MICRO AND NON-MICRO
4938 I II 3/31/1983 LOFTUS BRYAN CHEMICALS LTD BROMPHENIRAMINE MALEATE
4939 I II 1/21/1983 SANDOZ LTD PHARMACEUTICAL DIV OXAZEPAM
CHEMICAL DEVELOPMENT
4940 A IV 3/29/1983 DDP SPECIALTY ELECTRONIC SILASTIC™ 7-48XX BIOMEDICAL GRADE LIQUID
MATERIALS US 9 LLC SILICONE RUBBERS
Page 145
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4941 I II 4/26/1983 SIGMA F AND D DIV LTD TRIZMA BASE AS PROCESSED IN THE SAINT
LOUIS, MISSOURI FACILITIES
4942 A II 4/29/1983 INDENA SPA RESERPINE USP
4943 I II 4/25/1983 SANOFI WINTHROP INDUSTRIE MANUFACTURING SITE, FACILITIES,
PERSONNEL AND GENERAL OPERATING
PROCEDURES IN AMBARES, FRANCE.
4944 I II 1/10/1983 DIOSYNTH BV DEXAMETHASONE ACETATE MICRO AND NON
MICRO
4945 I II 4/28/1983 AB ASTRA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SODERTALFE, SWEDEN.
4946 I I 4/26/1983 DESITIN WERK CARL KLINKE GMBH PRODUCTION OF PHENYTOIN SODIUM, INJECT.
IN HAMBURG,GER
4947 I II 4/27/1983 MALLINCKRODT INC FACILS & PERSONNEL FOR THE RAD PHARM
INC CYCLOTRIN ON MAHLER RD. CA.
4948 I II 6/8/1983 HOECHST AG MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES
4949 I II 5/23/1983 JT BAKER CHEMICAL CO METHENAMINE HIPPURATE
4950 I II 2/15/1983 DIOSYNTH BV ALLOPURINOL
4951 I II 5/25/1983 FDC PRIVATE LTD FACILS & GEN. OPERATING PROCEDS. FOR GR
OF BULK DRUG PRODS: W/FORMU
4952 I II 4/28/1983 AB ASTRA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
4953 A II 5/31/1983 SEKISUI MEDICAL CO LTD L-METHIONINE
4954 I I 4/21/1983 EUDERMA SRL MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ITALY.
4955 I II 4/22/1983 SANOFI SYNTHELABO INC AMIODARONE HYDROCHLORIDE
4956 I II 4/11/1983 CILAG CHEMIE AG CHLORZOXAZONE
4957 I II 5/17/1983 FARMABOIS TRIAMCINOLONE ACETONIDE
4958 I II 2/15/1983 DIOSYNTH BV CHENODEOXYCHOLIC ACID H.M.
4959 I II 5/18/1983 PHARMA-WALDHOF GMBH 5-FLUORO-URACIL,PRODUCT 4965
4960 I II 5/31/1983 DAIICHI PURE CHEMICALS CO LTD L-TRYPTOPHAN
4961 I II 4/19/1983 SANOFI CHIMIE MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ARAMON.
4962 I II 5/20/1983 PAN MEDICA SA SYNTHESIS & INVEST. DOSAGE FORM
PREPARATION FOR TRIPTOSINE
4963 I II 5/9/1983 ZYMA SA ZY-15029
4964 I III 3/22/1983 PFIZER INC PACKAGING COMPONENTS-PRIMARILY USED IN
PRODUCTION AT BKLYN, NY PLANT
Page 146
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4965 I I 6/21/1983 PROTER LABORATORY SPA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN OPERA, MILAN, ITALY.
4966 I II 3/14/1983 BOEHRINGER MANNHEIM GMBH D-PHENYLALANINE
4967 I II 4/7/1983 JUSTE SAQF MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
4968 I II 5/17/1983 GLAXO PHARMACEUTICALS LTD 0/4 DIHYDROCHLORIDE DIHYDRATE
(CEPHALORIDINE ROUTE-CP)-ULVERSTON
PLANT
4969 I V 5/18/1983 PAN MEDICA SA PRECLINICAL ANIMAL STUDIES FOR TRIPTOSINE
Page 147
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
4988 I II 6/9/1983 PARKE DAVIS AND CO FACILITIES & GENERAL OPERATING
PROCEDURES (SANDY, UTAH LOCATION)
4989 I II 6/28/1983 RHODIA OPERATIONS GUAIFENESIN (GLYCEROL GUAIACOLATE)
4990 A II 6/21/1983 SANDOZ GMBH 7-AMINO-CEPHALOSPORANIC ACID (7-ACA)
4991 A II 5/28/1983 TEVA PHARMACEUTICAL INDUSTRIES HALOPERIDOL
LTD
4992 I II 6/21/1983 ANTIBIOTICOS SPA TRIPROLIDINE HCL. BULK FORM
4993 I IV 2/15/1983 DIOSYNTH BV EGG-YOLK PHOSPHOLIPID
4994 I IV 7/13/1983 LA DREYFUS CO DREYCO CHEWING GUM BASE
4995 I II 4/22/1983 YODOGAWA PHARMACEUTICAL CO LTD CHLORZOXAZONE USP XX
4996 A II 6/21/1983 SANDOZ GMBH 7-ACT
4997 I II 7/8/1983 SMITHKLINE AND BECKMAN INC DIPHENYLPYRALINE HCL--PRODUCED IN
SMITHKLINE FACILS-CONSHOHOCKEN, PA.
4998 I II 5/9/1983 SANDOZ LTD PHARMACEUTICAL DIV SF86-327 (E)-N-(6,6-DIMETHYL-2-HEPTEN-4-YUL)-
CHEMICAL DEVELOPMENT N--METHYL-1-NAPHTHALALENE
4999 I II 5/26/1983 PROCTER AND GAMBLE CO MIAMI VALLEY LABS-EAST MIAMI RIVER RD.,
CINCINNATI,OHIO
5001 I II 6/15/1983 GLAXOCHEM LTD VITAMIN B 12(CYANOCOBALAMIN)
5002 I II 5/31/1983 PERSTORP CHEMICALS AB MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
5003 I II 5/19/1983 DEGUSSA AG WERK RADEBEUL L-TYROSINE ETHYLESTER HCL-BY REXIM S.A.
DIV. OF DEGUSSA, HAM, ENGLAND
5004 A III 6/20/1983 ACTION TECHNOLOGY RUBBER CMPDS & GASKETS
5005 I II 5/3/1983 SANOFI CHIMIE AMIODARONE HCL
5006 I II 6/29/1983 SMITHKLINE BEECHAM ANIMAL HEALTH DIETHYLCARBAMIZINE CITRATE
5007 I II 6/23/1983 SALK INSTITUTE NAL-ARG ANTAGONIST
5008 I II 6/14/1983 VITARINE CO INC SUB WEST CHEMICAL PHENYLEPHRINE HCL 20MG S.R. CAPS
PRODUCTS INC
5009 I IV 7/11/1983 PETROLITE CORP BARECO DIV SILTEX M AS PROCESSED IN OKLAHOMA
FACILITIES
5010 I IV 7/14/1983 KV PHARMACEUTICAL CO PROTECTIVE CREAMS,LOTIONS-WESTPORT
FACIL. ON SCHUETZ RD, ST. LOUIS, MO
5011 I II 8/1/1983 INNOTHERA AMERICA CETIEDIL
5012 I II 8/4/1983 INDUSTRIA FARMACEUTICA SERONO TP-1 SERONO (THYMOSTIMULIN)
SPA
5013 I II 7/29/1983 JAME FINE CHEMICALS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BOUND BROOK PLANT.
5014 A III 2/1/1983 AMCOR FLEXIBLES SELESTAT ALUMINUM FOIL PACKAGING MATERIALS
5015 I III 7/22/1983 BALL CORP COEXTRUDED PKG MATLS-EVANSVILLE, IND,
FACIL: 1.BALL PLASTICS 454(TM)
5016 I II 4/20/1983 E MERCK CHLORTHALIDONE USP
5017 I II 5/19/1983 DEGUSSA AG WERK RADEBEUL AMINO ACID MIXTURES I AS PRODUCED BY
REXIM SA DIV DEGUSSA HAM FRANCE
Page 148
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5018 I II 7/29/1983 JAME FINE CHEMICALS INC METHENAMINE HIPPURATE
5019 A II 6/29/1983 SIEGFRIED EVIONNAZ SA PRILOCAINE HCL
5020 A III 5/5/1983 KURZ TRANSFER PRODUCTS LP COLORIT P 912 BLACK PIGMENT FOIL
5021 I II 7/18/1983 ANDRULIS RESEARCH CORP BULK SYNTHESIS OF NSC 271674
5022 I II 3/22/1983 SANDOZ LTD PHARMACEUTICAL DIV L(-)-POLYLACTIC ACID FOR USE IN DRUG
CHEMICAL DEVELOPMENT DOSAGE FORMS
5023 I II 7/25/1983 WAITAKI INTERNATIONAL BIOSCIENCES METOCLOPRAMIDE MONOHYDROCHLORIDE
SUB WAITAKI CANADA LTD
5024 A II 6/28/1983 SIEGFRIED EVIONNAZ SA BENOXINATE HYDROCHLORIDE
5025 A II 7/21/1983 OLON SPA DOXEPINE HYDROCHLORIDE
5026 I II 7/26/1983 MEIJI SEIKA KAISHA LTD ASHIGARA PLANT (WHERE THP-ADRIAMYCIN IS
GR & CONTROLLED)
5027 A II 5/17/1983 FIS FABBRICA ITALIANA SINTETICI SPA LORAZEPAM
5028 I I 7/28/1983 UCB,SOCIETE ANONYME PHARM DIV PERSONNEL FACILITIES & GENERAL
OPERATING PROCEDURES BRAINE-L'ALLEUD
5029 I II 7/29/1983 EUTICALS LTD ISOSORBIDE-5-MONONITRATE, DILUTED
5030 I II 4/27/1983 JUSTESA IMAGEN SAU SODIUM DIATRIZOATE
5031 I II 6/30/1983 FERMION OY VERAPAMIL HCL BP 80 ADD. 82
5032 A II 8/5/1983 SIEGFRIED PHARMACHEMIKALIEN CAFFEINE (HYDROUS, ANHYDROUS FORMS)
MINDEN GMBH
5033 I II 5/19/1983 DEGUSSA AG WERK RADEBEUL L-ARGININE ACETATE AS PRODUCED BY REXIM
S.A.DIV DEGUSSA -HAM FRANCE
5034 I II 5/31/1983 ER SQUIBB AND SONS INC TRIFLUPROMAZINE AND TRIFLUPROMAZINE
HCL
5035 I IV 5/6/1982 SCM CORP SATINA III-PROCESSED IN JOLIET, ILLINOIS
FACILITIES
5036 I III 5/6/1982 SUNOCO CHEMICAL CO POLYPROPYLENE RESINS IN PP11M12ACS
SERIES
5037 I III 7/12/1983 BALL CORP COEXTRUDED PACKAGING MATERIALS-
PROCESSED EVANSVILLE FACILITIES
5038 A II 8/15/1983 JOHNSON MATTHEY PHARMACEUTICAL FENTANYL CITRATE (BULK)
MATERIALS
5039 I II 7/26/1983 ARCO CHEMICAL CO TEBOL 99 ALCOHOL (HIGH PURITY TERTIARY
BUTYL ALCOHOL) PASEDENA TX
5040 I II 7/15/1983 UPJOHN CO MENOGAROL (U-52,047,Nsc-269148)PRODUCED
KALAMAZOO, MICHIGAN FACILITIES
5041 A II 7/9/1983 EVONIK NUTRITION AND CARE GMBH LORAZEPAM
5042 I III 6/22/1983 BALL CORP COEXTRUDED PACKAGING MATERIALS AS
PROCEDURES IN EVANSVILLE IN
5043 I II 5/26/1983 SCHERING CANADA INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN POINTE CLAIRE, QUEBEC.
5044 I II 8/9/1983 DAIICHI SANKYO CHEMICAL PHARMA CO LEVODOPA AS PRODUCED IN THE HIRATSUKA
LTD PLANT
5045 I II 11/28/1983 UCB,SOCIETE ANONYME PHARM DIV MECLIZINE HCL TABS IN BULK 12.5MG
Page 149
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5046 A II 6/30/1983 CERBIOS PHARMA SA LEUCOVORIN CALCIUM
5047 A II 7/25/1983 PHARMACIA AND UPJOHN CO WHOLLY ESTRADIOL CYPIONATE USP
OWNED SUB PFIZER INC
5048 I II 7/22/1983 SANOFI PHARMACEUTICALS INC ACETAMINOPHEN
5049 I II 6/30/1983 DIAMALT AG S-CARBOXYMATHYL-L-CYSTEINE
5050 I II 7/28/1983 UCB,SOCIETE ANONYME PHARM DIV MECLIZINE HCL TABS-BULK 25MG
5051 I II 6/24/1983 LABORATOIRES DETUDES ET DE MANUFACTURING SITE, FACILITIES,
RECHERCHES SYNTHELABO PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PORCHVILLE, ANTONY,
FRANCE.
5052 I II 4/7/1983 JUSTESA IMAGEN SAU MEGLUMINE DIATRIZOATE
5053 I I 4/11/1983 SPECIALTES SEPTODONT MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDUES.
5054 I II 6/24/1983 EMSON RESEARCH INC PERSONNEL FACILITIES & GENERAL
OPERATING PROCEDURES
5055 I II 7/27/1983 SYNCOR INTERNATIONAL CORP PERSONNEL, FACILITIES & GENERAL
OPERATING PROCEDURES-GLENDALE CA
PLANT
5056 I II 9/7/1983 ROUSSELL UCLAF L-5-HYDROXYTRYPTOPHAN
5057 I I 9/1/1983 CONTECH LABORATORIES PERSONNEL FACILITIES & GENERAL
OPERATING PROCEDURES-GREENVILLE ILL
5058 I III 9/1/1983 TECHNICAL COATINGS CO SUB FOIL TO PVC HEAT SEAL PRODS-PRODUCED IN
BENJAMIN MOORE AND CO NUTLEY NJ FACILITIES
5059 I III 9/9/1983 INTERNATIONAL PACKING CORP PRODUCT BO-401
5060 I II 6/13/1983 FUJISAWA DEUTSCHLAND GMBH TAMOXIFEN CITRATE
5061 I II 8/22/1983 CHUNGHWA CHEMICAL SYNTHESIS AND ACETAMINOPHEN USP XX PWD &
BIOTECH CO LTD ACETAMINOPHEN W/10% STARCH
5062 I II 7/14/1983 SCHERING AG QUINIDINE GLUCONATE
5063 I II 9/5/1983 ANTIBIOTICOS SPA FLURANDRENOLIDE USP BULK FORM (NON-
STERILE)
5064 I III 5/9/1983 PANTASOTE INC PVC COMPOUNDS AND/OR FILMS (PRO.N.J.
FACILITIES):1. 4504P1000 PVC
5065 I II 7/22/1983 SIGMA F AND D DIV LTD MUSCIMOL
5066 I I 9/6/1983 YAMANOUCHI PHARMACEUTICAL PERSONNEL FACILITIES & GENERAL
COMPANY LTD OPERATING PROCEDURES
5067 I II 8/31/1983 AYERST LABORATORIES INC DIV GONADORELIN HCL
AMERICAN HOME PRODUCTS CORP
5068 I II 6/22/1983 NORDION CANADA INC LEAD & THALLIUM 201-PRODUCED IN AECL TRID
CHEM. ANNEX-VANCOUVER, CAN
5069 I II 7/27/1983 MEMBRANA INC PERSONNEL FACILITIES & GENERAL
OPERATING PROCEDURES
5070 I II 7/26/1983 DINAMITE DIPHARMA SPA GUANETHIDINE MONOSULFATE
5071 I III 8/19/1983 AMERICAN NATIONAL CAN CO LACQUERED PRINTED ALUMINUM FOIL HEAT
SEAL COATED PACKAGING PRODUCTS
Page 150
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5072 I III 8/14/1983 NATIONAL STARCH AND CHEMICAL CO STERILE PRODUCTS FACILITIES LOCATED IN
NERVIANO, MILAN, ITALY
5073 I II 7/15/1983 ORGANICHEM CORP PHENYLEPHRINE HCL USP
5074 I II 9/6/1983 ASTELLAS PHARMA INC CEFOTETAN
5075 I II 8/22/1983 MDS NORDION IODINE 125 PRODUCED IN KANATA ISOTOPE
PROCESSING FACIL (AECL-KIPE)
5076 I II 5/24/1983 SUMIKA FINE CHEMICALS CO LTD DOXEPIN USP XX
5077 I II 9/14/1983 VETERANS ADMINISTRATION TC-99M-PROPYLENE AMINE OXIME (TC-99M-
PnAO)
5078 I II 9/12/1983 OMNICHEM SA 5-HYDROXY-L-TRYPTOPHAN
5079 I II 8/24/1983 KLINGE PHARMA GMBH PROPRANOLOL HCL
5080 I II 7/4/1983 ZAMBON SPA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ALMISANO DI LONIGO
(VICENZA).
5081 I II 8/11/1983 ORGAMOL SA DISOPYRAMIDE
5082 I II 9/30/1983 SIGMA F AND D DIV LTD BETAINE FREE BASE ANHYDROUS PURCHASED
BY SIGMA LTD LONDON FOR USA
5083 I II 7/15/1983 NATIONAL RUBBER AND BACKING CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN LONG ISLAND, NEW YORK.
5084 I II 6/24/1983 EASTMAN KODAK COMPANY STERILE PROCESSING FACILITY LOCATED IN
SHIRLEY, NEW YORK
5085 I II 8/30/1983 ROMAN INDUSTRIES CO LTD HUMAN CHORIONIC GONADOTROPIN
5086 I II 7/29/1983 IRISH FINE CHEMICALS LTD DEXCHLORPHENIRAMINE MALEATE
5087 I I 8/8/1983 ELI LILLY INDUSTRIES INC GENERAL OPERATING PROCEDURES FOR THE
PUERTO RICO FACILITY
5088 I II 8/15/1983 CHIREX LTD PHENTERMINE BASE & HCL
5089 I II 9/20/1983 SIGMA F AND D DIV LTD ANTHRAX ANIMAL MODEL LOCATED IN
BETHESDA, MARYLAND
5090 I II 7/20/1983 ACF CHEMIEFARMA NV QUINIDINE BISULFATE
5091 A II 7/4/1983 FIS FABBRICA ITALIANA SINTETICI SPA ACETYLCYSTEINE, USP
5092 I II 10/12/1983 BACHEM INC SOMATOSTATIN; BULK FORM
5093 I II 10/3/1983 KABI PHARMACIA HEPAR INC CALCIUM HEPARIN
5094 I II 10/10/1983 RECORDATI INDUSTRIA CHIMICA E DISOPYRAMIDE PHOSPHATE
FARMACEUTICA SPA
5095 I II 10/12/1983 VITARINE CO INC SUB WEST CHEMICAL L-LYSINE MONOHYDROCHLORIDE TABLETS
PRODUCTS INC
5096 I IV 9/14/1983 V V DRUG
5097 I II 8/22/1983 EPROVA AG PHOSPHORIC ACID (76541-72-5) DESIGNATED AS
SR-202
5098 I III 9/30/1983 BALL CORP COEXTRUDED PKG MATERIALS
5099 I II 8/4/1983 EASTMAN KODAK CO ACETOHYDROXAMIC ACID
(LITHOSTAT)PROCESSED ROCHESTER, N.Y.
FACILITIES
Page 151
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5100 I III 5/26/1981 3M PHARMACEUTICALS HDPE CLOSURE LINER AS PROCESSED IN ST.
PAUL, MINN. FACILITIES
5101 I II 7/18/1983 SIGMA F AND D DIV LTD D-PANTETHINE
5102 I II 9/16/1983 ELI LILLY AND CO FENOPROFEN CALCIUM, BULK FORM
5103 I II 8/23/1983 SCHERING AG IOTROL USING 5-NITROISOPHTHALIC ACID AS
STARTING MATERIAL
5104 I II 7/25/1983 TEVA PHARMACEUTICAL INDUSTRIES CHLORTHALIDONE
LTD
5105 I II 9/27/1983 QUANTUM PHARMICS LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN AMITYVILLE, NEW YORK.
5106 I II 9/20/1983 SOCIETE LIPHA LORTALAMINE (LM 1404) AS PROCESSED IN THE
LYON FACILITY
5107 I II 9/15/1983 AMIDE PHARMACEUTICAL INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN LITTLE FALLS, NEW JERSEY.
5108 I II 9/9/1983 JANSSEN PHARMACEUTICA NV OXATOMIDE-R 35443 AS PROCESSED IN THE
BELGIUM FACILITY
5109 I II 9/2/1983 SANDOZ LTD PHARMACEUTICAL DIV CHLORTHALIDONE
CHEMICAL DEVELOPMENT
5110 I II 8/26/1983 AMERSHAM RADIOCHEMICAL CENTER TAURO-23-[75Se]-SELENA-25 HOMOCHOLIC ACID
(DESIGNATED AS SeHCAT)
5111 I II 8/31/1983 THATCHER CHEMICAL CO MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDUES IN SALT LAKE CITY, UTAH.
5112 I I 6/22/1983 CYANAMIDE OF CANADA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BAIE D'URFE, QUEBEC
CANADA.
5113 I II 9/15/1983 GOEDECKE AG LEVOBUNOLOL HYDROCHLORIDE (1-BUNOLOL
HYDROCHLORIDE)
5114 I II 9/20/1983 LIPHA SAS LORTALAMINE (LM 1404) IN FINISHED DOSAGE
FORMS PRODUCED LYON FACILITY
5115 I II 9/12/1983 L PERRIGO CO MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ALLEGAN, MICHIGAN.
5116 A IV 5/23/1983 GATTEFOSSE SAS PRECIROL ATO 5
5117 A III 9/14/1983 THE NIPPON SYNTHETIC CHEMICAL ETHYLENE-VINYLACETATE-VINYLALCOHOL
INDUSTRY CO LTD COPOLYMER (SOARNOL)
5118 I III 9/19/1983 OWENS ILLINOIS INC PLASTIC PRODUCTS
5119 I II 9/20/1983 SIGMA F AND D DIV LTD DEHYDROISOANDROSTERONE-3-
SULFATE,SODIUM SALT
5120 I II 10/14/1983 KABI PHARMACIA HEPAR INC CHONDROCTIN SULFATE
Page 152
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5121 I II 10/11/1983 MERCK SHARP AND DOHME RESEARCH BULK FORM OF DRUG PRODUCT L-590,153
LABORATORIES DIV MERCK AND CO INC PROCESSED RAHWAY, N.J. FACILITIES
Page 154
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5175 I II 12/15/1983 PHARMACHEMIE BV MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN HAARLEM, HOLLAND.
5176 I II 12/19/1983 ORGANICHEM CORP ENCAINIDE HCl
5177 I II 11/4/1983 SIBEFAT SPA ACEPROMAZINE MALEATE
5178 I II 11/30/1983 LABORATORY ANALYTICAL BIOLOGY INC NITROGLYCREINE ANALYSIS IN PLASMA
CARRIED OUT BY LAB IN GERMANY
5179 I II 12/13/1983 SALK INSTITUTE NORLEUCINE 27, HUMAN PANCREATIC GROWTH
HORMONE RELEASING FACTOR (NG-29
Page 155
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5201 I II 1/3/1984 FRESENIUS USA INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
5202 A II 1/3/1984 PHARMACIA AND UPJOHN CO LLC DINOPROSTONE USP
WHOLLY OWNED SUB OF PFIZER INC
5203 I II 1/3/1984 HEINRICH MACK NACHF MITOXANTRONE DIHYDROCHLORIDE
5204 A II 12/22/1983 EXCELLA GMBH AND CO KG TAMOXIFEN CITRATE
5205 I II 1/11/1984 ORION CORP FARMOS CHEMICAL PLANT IBUPROFEN
5206 I II 1/11/1984 USV LABORATORIES INC SUB RORER MANUFACTURING SITE, FACILITIES,
GROUP PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MANATI, PUERTO RICO
FACILITY ON SAN JOSE ROAD.
5207 I I 12/7/1983 LTS LOHMANN THERAPIE SYSTEME MANUFACTURING SITE, FACILITIES,
GMBH PERSONNEL, GENERAL OPERATING
PROCEDURES IN NEUWEID, FEDERAL
REPUBLIC OF GERMANY.
5208 A II 1/9/1984 FIS FABBRICA ITALIANA SINTETICI SPA
OXAZEPAM
5209 I IV 12/30/1983 JRS PHARMA LP EMCOMPRESS (DIBASIC CALCIUM PHOSPHATE,
DIHYDRATE USP XX
5210 I I 1/26/1984 ISOMEDIX INC FACILITIES & CONTROLS FOR IRRADIATION
PROCESSING(PLANT IN PUERTO RICO)
5211 I II 2/8/1984 CUSTOM CHEMICAL LABORATORIES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL , AND GENERAL OPERATING
PROCEDURES IN INDIANAPOLIS PLANT ON
GUION ROAD.
5212 I II 12/1/1983 SIEGFRIED AG AMILORIDE HCL
5213 I II 6/15/1983 SIGMA F AND D DIV LTD PYRIDOXAL 5-PHOSPHATE
5214 I III 11/22/1983 DOW CORNING CORP EXPERIMENTAL LATEX XD 30612.05 PRODUCED
MIDLAND, MICHIGAN FACILITIES
5215 I II 11/21/1983 SCHERING AG MICRONIZED PREDNISONE
5216 I II 12/9/1983 DAIICHI SANKYO CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SHIZUOKA JAPAN.
5217 I II 12/1/1983 SANDOZ LTD PHARMACEUTICAL DIV NAFTIFINE HCl (SN 105-843 ch) PRODUCED IN
CHEMICAL DEVELOPMENT THE BASLE, SWITZERLAND PLANT
5218 I II 12/16/1983 A INC ZETAPREP DEAE-CELLULOSE ION EXCHANGE
MEDIA (PRODUCED CT. FACILITIES)
5219 I II 12/23/1983 WAITAKI INTERNATIONAL BIOSCIENCES 5-AMINOSALICYLIC ACID
SUB WAITAKI CANADA LTD
5220 I II 1/17/1984 AYERST WYETH PHARMACEUTICALS MANUFACTURING SITE, FACILITIES,
INC PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN GUAYAMA, PUERTO RICO.
5221 I II 12/29/1983 HEICO CHEMICALS DIV WHITTAKER POTASSIUM CHLORIDE
CORP
Page 156
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5222 I II 1/19/1984 MALLINCKRODT INC BIOLOGICAL INDICATOR PROGRAM APPLIED
MARYLAND HEIGHTS, MO PLANT SITE
5223 A II 12/16/1983 FIS FABBRICA ITALIANA SINTETICI SPA TEMAZEPAM
5224 I II 1/18/1984 UPJOHN CHEM CO ESMOLOL HCl
5225 I II 12/5/1983 SANDOZ LTD PHARMACEUTICAL DIV RS-86 AMPULS 10 mg/ml AS PRODUCED IN THE
CHEMICAL DEVELOPMENT BASLE, SWITZERLAND PLANT
5226 I II 1/20/1984 RUETGERS NEASE CHEMICAL CO INC ZINC PYRION - NS
5227 I II 12/20/1983 GANES CHEMICALS INC PENNSVILLE VERAPAMIL HYDROCHLORIDE
5228 I IV 1/18/1984 DOW CORNING CORP ION EXCHANGE RESINS (DOWEX TRADE MARK)
5229 I III 2/9/1984 PANTASOTE INC PVC FILMS
5230 I IV 11/15/1983 ICI AMERICAS INC BRIJ 93 (POLYOXYETHYLENE (2) OLYL ETHER)
5231 I II 2/22/1984 MONSANTO POLYMER PRODUCTS CO LACTIC ACID, BULK FORM
5232 I II 12/27/1983 IBARAKI KASEI CO LTD THE MANUFACTURE AND QUALITY CONTROL OF
CHLORZOXAZONE
5233 I II 2/17/1984 MALLINCKRODT INC CODEINE SULFATE
5234 I II 2/20/1984 ROHM AND HAAS CO AMBERLITE IRP-69 & AMBERLITE IRP-70
5235 I II 1/25/1984 ORGAMOL SA ALLOPURINOL
5236 I II 2/10/1984 SHOWA INDUSTRY CO LTD DIMETHYL SULFOXIDE (DMSO-P)
5237 I IV 1/20/1984 SUTTON LABORATORIES GERMALL 115 (IMIDUREA NF)
5238 I II 2/16/1984 DYNAMIT NOBEL AG NITROGLYCERINE 10% IN LACTOSE
5239 I V 2/27/1984 STERIS ISOMEDIX SERVICES CONTRACT STERILIZATION FACILITY IN WHITBY,
ONTARIO,CANADA
5240 A II 2/9/1984 SIEGFRIED EVIONNAZ SA CARISOPRODOL
5241 I II 3/19/1984 FINE CHEMICALS CORP TRIFLUOPERAZINE HCL
5242 I II 1/24/1984 ACF CHEMIEFARMA NV SULFADIMIDE PH EUR/SULFAMETHAZINE USP
5243 I II 12/7/1983 SANDOZ LTD PHARMACEUTICAL DIV RS-86 HYDROBROMIDE AS PRODUCED IN THE
CHEMICAL DEVELOPMENT BASLE, SWITZERLAND PLANT
5244 I II 2/9/1984 CIBA GEIGY LTD CGP LL637 ADJUVANT--CHEMISTRY & GMP
5245 I III 1/20/1984 LABLABO METERED AEROSOL VALVES
5246 I III 1/25/1984 ARTEK SYSTEMS CORP GENERATOR FLUID PATH KITS
5247 I II 2/7/1984 BIOCHEMIE DEUTSCHLAND GMBH 7-ACA, BULK FORM (7-
AMINOCEPHALOSPORANIC ACID
5248 I II 1/11/1984 DAIICHI SANKYO CO LTD DL 8280 MEFOXACIN A & PLACEBO TABS
5249 I II 1/3/1984 PHOTOFRIN INC DIHEMATOPORPHYRIN ETHERS (DHE) TRADE
NAME, PHOTOFRIN II
5250 I II 12/15/1983 SANDOZ LTD PHARMACEUTICAL DIV RS-86 CAPSULES IN 0.25 mg AND 1.0 mg (BASLE,
CHEMICAL DEVELOPMENT SWITZERLAND PLANT)
5251 I II 2/9/1984 CIBA GEIGY LTD ADJUVANT CGP 11637:TOXICITY STUDIES &
RESULTS CONDUCTED IN EUROPEAN FA
5252 I II 1/24/1984 PATHEON INC TORONTO REGION MANUFACTURING SITE, FACILITIES,
OPERATIONS PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MISSISSAUGA, ONTARIO,
CANADA.
5253 A IV 12/28/1983 GATTEFOSSE SAS GELUCIRE 44/14; GELUCIRE 50/02 AND
GELUCIRE 50/13
Page 157
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5254 I II 1/16/1984 SANOL SCHWARZ DEPONIT NITROGLYCERINE TRANSDERMAL
THERAPEUTIC SYSTEM (MONHEIM PLANT)
5255 I II 2/23/1984 SANOFI WINTHROP INC TYROPANOATE SODIUM
5256 I II 1/30/1984 MORINAGA MILK INDUSTRY CO LTD LACTULOSE SYRUP (MLS-50)
5257 I II 5/11/1983 SANTEN PHARMACEUTICAL CO LTD TROPICAMIDE MYDRIATIC
5258 I II 7/20/1983 SIGMA F AND D DIV LTD INDOMETHACIN
5259 I II 2/8/1984 WATSON LABORATORIES INC MANUFACTURING SITE, FACILITIES ,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN LIBERTYVILLE, ILLINOIS.
5260 I III 1/25/1984 3M PHARMACEUTICALS SCOTCHPAR BRAND FILMS
5261 A II 1/23/1984 MERCK AND CIE CALCIUM FOLINATE ( CALCIUM LEUCOVORIN )
5262 I II 1/18/1984 VAN DYK AND CO INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BELLEVILLE, NEW JERSEY.
5263 I I 12/1/1983 PREMIUM PLASTICS INC SOP FOR G PKG MATERIALS (EAST BRUNSWICK,
N.J.) PRODUCT INFO INCLUDED
5264 I II 7/27/1983 SIGMA F AND D DIV LTD STEARYLAMINE AS PROCESSED BY ARMAK FOR
SIGMA F & D
5265 I II 1/18/1984 PFANSTIEHL LABORATORIES INC 5-THIO-D-GLUCOSE
5266 I II 2/7/1984 SCHNELL PLASTIC INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN HUNTINGTON BEACH,
CALIFORNIA.
5267 I II 2/17/1984 STERIS ISOMEDIX SERVICES MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CERIANO LAGHETTO PLANT.
5268 I II 10/20/1983 INDUSTRIA CHIMICA PROFARMACO SPA ACETYL OXIDE (OXAZEPAM INTERMEDIATE)
5269 I IV 8/12/1983 SIGMA F AND D DIV LTD L-ALPHA-PHOSPHATIDYLCHOLINE, III-E
(HEXANE SOLUTION)
5270 I II 11/29/1983 DIOSYNTH BV L-ALPHA-METHYLDOPATE HYDROCHLORIDE
5271 I I 2/21/1984 HOUBA INC FACILITIES & GENERAL OPERATING
PROCEDURES ON STATE ROAD, CULVER,IN.
5272 I II 3/2/1984 NATIONAL CANCER INSTITUTE 3-O-LAUROYL-L-CARNITINE HYDROCHLORIDE
(LLC) PRECLINICAL AND CLINICAL DATA
5273 I II 3/8/1984 GALIBIA SPA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN GALIBI-TODI.
5274 I II 3/1/1984 HOVIONE FARMACIENCIA SA BETAMETHASONE 17,21-DIPROPIONATE
5275 I IV 1/31/1984 GATTEFOSSE ESTABLISSEMENTS TEFOSE 2561
5276 A II 3/2/1984 DYNAMIT NOBEL GMBH NITROGLYCERINE 5% IN MIGLYOL 812 NEUTRAL
EXPLOSIVSTOFF UND SYSTEMTECHNIK OIL
5277 I II 2/21/1984 HOUBA INC ETIOCHOLANOLONE (3,-ALPHA-HYDROXY-5,-
BETA-ANDROSTAN-17-ONE)CULVER,IND
5278 I II 2/17/1984 NORDION CANADA INC XENON GAS XE-133
Page 158
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5279 I II 3/8/1984 INDUSTRIA FARMACEUTICA SERONO HUMAN MENOPAUSAL GONADOTROPIN
SPA (hMG)PROCESSED IN THE GALIBIA-TODI PLANT
5280 I II 4/20/1984 ALDRICH CHEMICAL CO INC PENTAMIDINE ISETHIONATE (PRODUCT W149-5)
Page 159
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5300 I II 3/16/1984 PENCO OF LYNDHURST INC CODEINE PHOSPHATE
5301 I II 9/29/1983 EXPANSIA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES ARAMON, FRANCE.
5302 I I 2/24/1984 SKYLAND SCIENTIFIC SERVICES INC MANUFACTURING SITE, FACILITEIS,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BELGRADE, MONTANTA.
5303 I II 11/21/1983 SIPSY CHIMIE FINE SCA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN AVRILLE, FRANCE.
5304 I II 2/8/1984 VICKS HEALTH CARE DIV RICHARDSON MANUFACTURING SITE, FACILITIES,
VICKS INC PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN HATBORO, PENNSYLVANIA.
5305 I II 3/14/1984 ASTA WERKE AKTIENGESELLSCHAFT MESNA AMPOULES
5306 I IV 3/12/1984 ELAN CORP PLC ELANPRES CAPSULES
5307 I II 3/30/1984 IOLAB PHARMACEUTICALS SUB MANUFACTURING SITE, FACILITIES,
JOHNSON AND JOHNSON CO PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SAN GERMAN, PUERTO RICO
(NORTE INDUSTRIAL PARK)
5308 I II 2/29/1984 BEECHAM LABORATORIES DIV STERILE AMOXICILLIN SODIUM
BEECHAM INC
5309 I II 2/16/1984 ORION CORP FERMION TRIOXSALEN, USP XX
5310 I II 2/13/1984 EGIS PHARMACEUTICALS PRIVATE LTD TAMOXIFEN CITRATE
5311 I II 3/19/1984 HEINRICH MACK NACHF CYTARABINE
5312 I II 3/20/1984 MAPRIMED SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MORGUIONDO 2011,
ARGENTINA
5313 I II 3/2/1984 ISOCHEM SA MANUFACTURING PROCEDURES FOR
ETINTIDINE HYDROCHLORIDE
5314 I II 4/11/1984 KYOWA HAKKO KOGYO CO LTD ACEGLUTAMIDE ALUMINUM GRANULES (KW-110)
Page 162
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5373 I II 5/24/1984 PRIVATE FORMULATIONS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN EDISON, NEW JERSEY.
5374 I II 5/23/1984 ABBOTT LABORATORIES METHOCARBAMOL
PHARMACEUTICAL PRODUCTS DIV
5375 I II 5/17/1984 FRESENIUS USA INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CANTON, MASSACHUSETTS.
5376 I II 5/24/1984 BOEHRINGER INGELHEIM PHARMA YOHIMBINE HYDROCHLORIDE AS PROCESSED
GMBH AND CO KG IN THE INGELHEIM PLANT
5377 I IV 5/29/1984 DAVID MICHAEL AND CO INC FLAVORING FORMULATION (PRODUCED IN PHIL.
PA) 1. ARTIFIC. GRAPE # 7201
5378 I II 2/9/1984 SIGMA F AND D DIV LTD D-AMPHETAMINE SULFATE # A5880 FD & (+)
METHAMPHETAMINE HCL NO. M8750FD
5379 I II 6/1/1984 PFANSTIEHL LABORATORIES INC 9-BETA-D-ARABINOFURANOSYL ADENINE
5380 I II 5/11/1984 ORION CORP FARMOS CHEMICAL PLANT DETOMIDINE HYDROCHLORIDE
Page 165
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5453 I II 2/20/1984 WHITMOYER LABS INC CHLORHEXIDINE (BASE, DIHYDROCHLORIDE,
GLUCONATE AND DIACETATE)
5454 I II 6/25/1984 ORION CORP LTD SUCRALFATE
5455 I II 6/26/1984 TEMMLER WERKE VEREINIGTE KETOPROFEN S.R. CAPSULES
CHEMISCHE FABRIKEN
5456 I II 7/18/1984 SCHERING AG DIFLUCORTOLONE-21-VALERATE
5457 I IV 6/22/1984 DUPONT NUTRITION USA INC AQUATERIC CD-910 AQUEOUS ENTERIC
COATING
5458 I IV 6/29/1984 GATTEFOSSE ESTABLISSEMENTS GELUCIRE 46/08; 48/09; AND 53/10
5459 I II 6/27/1984 ORGANICHEM CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN HVIDOVRE AND
COPENHAGEN, DENMARK.
5460 I II 7/18/1984 AVECIA INC SDM-25 (25/75 ISOSORBIDE DINITRATE-
MANNITOL MIXTURE)
5461 I II 7/20/1984 SANKYO CO LTD BULK FORM OF NIMUSTINE HCL (NIDRAN)
5462 I II 7/17/1984 GEDEON RICHTER LTD KETAMINE HCL
5463 I II 7/20/1984 BIOTEK INC VAGINAL CONTRACEPTIVE SUPPOSITORIES
5464 I II 7/19/1984 LABORATOIRES DETUDES ET DE BETAXOLOL HYDROCHLORIDE
RECHERCHES SYNTHELABO
5465 I II 7/20/1984 COMPANIA ESPANOLA DE SINTESIS BETAMETHASONE VALERATE USP XX
QUIMICA SA
5466 I II 6/27/1984 ALFRED BENZON AS ACETARD(ACETYSALICYLIC ACID)C.R. TABS(3
DOSAGE FORMS)
5467 I II 7/18/1984 AVECIA INC SDM-47 (10/90 NITROGLYCERIN-PLASTISOL
MIXTURE)
5468 I II 7/20/1984 SANKYO CO LTD NIMUSTINE HCL (NIDRAN) IN VIALS
5469 I II 8/1/1984 OMNICHEM NV CIRAMADOL HYDROCHLORIDE
5470 I II 8/1/1984 MCNEIL PHARMACEUTICAL LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN STOUFFVILLE, ONTARIO,
CANADA.
5471 I IV 8/8/1984 GATTEFOSSE ESTABLISSEMENTS GELUCIRE 35/10 & GELUCIRE 42/12
5472 I II 3/30/1984 AMERSHAM RADIOCHEMICAL CENTER 111 INDIUM CHL RADIOCHEM SOLUTION
5473 I II 7/25/1984 WEST CO MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN WEST CO, MED PLASTICS DIV,
JERSEY SHORE, PA.
5474 I II 8/8/1984 EURAND AMERICA INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN DAYTON, OHIO.
5475 I II 7/20/1984 DIAMALT AG MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF PEPTIDES IN MUNICH,
GERMANY.
Page 166
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5476 I II 7/5/1984 NITA PHARMACEUTICAL LTD DESONIDE (PREDNACINOLONE 16,17
ACETONIDE
5477 I II 7/24/1984 AAI PHARMA LLC PROPOXYPHENE NAPSYLATE PRODUCED BY
TIPPECANOE LABS IN LAFAYETTE, IN.
5478 I II 7/19/1984 DINAMITE DIPHARMA SPA NAPROXEN SODIUM
5479 I III 5/22/1984 PRECISE TECHNOLOGY INC PACKAGING MATERIAL
5480 I II 4/24/1984 AMERSHAM INTERNATIONAL PLC 89 STRONTIUM CHL. RADIOCHEM SOLUTION-
AMERSHAM LABORATORY PROCESSED IN BUCKINGHAMSHIRE,ENG.
5481 I II 7/20/1984 DIAMALT AG SOMATOSTATIN
5482 I II 8/11/1984 PROSINTEX SPA TRIFLUOPERAZINE HCL
5483 I II 7/20/1984 HOECHST CELANESE CORP CHLORPROPAMIDE USP
5484 I II 8/1/1984 SANOFI SA NALMEFENE HYDROCHLORIDE
5485 I II 7/25/1984 ZAMBON SPA IBUPROFEN USP XX
5486 I II 7/17/1984 FINE CHEMICALS CORP MEDROXYPROGESTERONE ACETATE
5487 I II 6/13/1984 UPJOHN CO CORTISONE ACETATE USP, MICRO & NON
MICRO
5488 A III 7/27/1984 HOSPIRA INC ADD-VANTAGE® VIAL PLASTIC SHROUD
5489 I II 7/20/1984 SIFAVITOR SPA CLOTRIMAZOLE USP XX
5490 I II 7/12/1984 NOVOPHARM LTD FACILITIES, PERSONNEL, AND GENERAL
OPERATING PROCEDURES FOR THE
SCARBOROUGH, ONTARIO CANADA PLANT.
5491 I II 7/31/1984 LABORATOR MAG VIA MILANO NYLIDRIN HCL
5492 I II 6/12/1984 UPJOHN CO PREDNISONE ACETATE, MICRO & NON-MICRO
5493 I II 4/18/1984 INDUSTRIAL PHARMACEUTICAL HYDROFLUORIC ACID BURN JELLY
SERVICE LTD
5494 A II 1/11/1984 BOEHRINGER INGELHEIM PHARMA ATROPINE SULFATE
GMBH AND CO KG
5495 I IV 4/18/1984 AE STALEY CO PURIFIED SOYBEAN OIL AS PROCESSED IN THE
DECATUR, ILLINOIS FACILITIES
5496 I II 8/10/1984 ORTHO PHARMA PRIVATE LTD CHLORPROPAMIDE
5497 A II 7/30/1984 CORDEN PHARMA BERGAMO SPA CIMETIDINE
5498 A II 6/11/1984 PHARMACIA AND UPJOHN CO WHOLLY HYDROCORTISONE ACETATE USP, MICRO &
OWNED SUB PFIZER INC NON-MICRO
5499 I II 7/30/1984 AMERICAN CHEMICAL INDUSTRIAL CHLORPROMAZINE HCL USP(BULK)
CORP
5500 A II 8/15/1984 TEVA PHARMACEUTICAL INDUSTRIES TAMOXIFEN CITRATE USP
LTD
5501 I II 7/24/1984 SUMIKA FINE CHEMICALS CO LTD NIFEDIPINE USP XX
5502 I II 8/1/1984 REGIS CHEMICAL CO CLORGYLINE (REGIS CODE NO. 002061)
5503 I II 8/23/1984 MEIJI SEIKA KAISHA LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN KAWASAKI, KANAGAWA,
JAPAN.
5504 I II 6/23/1984 PFIZER INC PREDNISOLONE ACETATE USP,MICRO & NON
MICRO
Page 167
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5505 A II 7/16/1984 VALEANT PHARMACEUTICALS NORTH PYRIDOSTIGMINE BROMIDE
AMERICA
5506 A III 8/17/1984 HOSPIRA INC MICROBIOLOGICAL VALIDATION OF THE ADD-
VANTAGE FLEXIBLE CONTAINER
5507 I II 7/23/1984 SANDOZ LTD PHARMACEUTICAL DIV TEMAZEPAM
CHEMICAL DEVELOPMENT
5508 I II 8/20/1984 PARKE DAVIS DIV WARNER LAMBERT MANUFACTURING SITE, FACILITIES,
CO PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN GWENT, UNITED KINGDOM.
5509 I II 8/17/1984 KV PHARMACEUTICAL CO UNISOM CAPS(DOXYLAMINE USP)
5510 I IV 9/6/1984 BAYER AG BAYER PRODUCTS IN THE MAKROLON SERIES
5511 I II 9/7/1984 GEDEON RICHTER LTD PIPECURONIUM BROMIDE
5512 I IV 9/1/1984 PT GELATINDO MUKTI GRAHA PROCEDURES & COMPONENTS FOR
5513 I II 9/7/1984 CHEMSPEC CHEMICALS PVT LTD HEXACHLOROPHENE
5514 I II 7/6/1983 SIGMA F AND D DIV LTD ATROPINE METHYL NITRATE AS SUPPLIED BY
MAC FARALAN SMITH, LIMITED
5515 A II 7/23/1984 LOS ALAMOS NATIONAL LABORATORY STRONTIUM-82
DEPT ENERGY
5516 I IV 8/27/1984 MORGAN ADHESIVES CO PRESSURE SENSITIVE ADHESIVE SUBSTRATES
5517 I II 8/14/1984 HOUBA INC DEXBROMPHENIRAMINE MALEATE
5518 I III 9/6/1984 GE SILICONES BAYILONE LIQUID SILICONE RUBBER
PRODUCTS
5519 I II 9/5/1984 SUTTON LABORATORIES GERMALL II (DIAZOLIDINYL UREA)
5520 I I 6/15/1984 DAVID BULL LABORATORIES PTY LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MULGRAVE, AUSTRALIA.
5521 I II 8/16/1984 BIOCHEMIC GESELLSCHAFT MBH D-PENICILLAMINE
5522 I II 8/30/1984 MOEHS SA DIV SANOF SULFAMETHOXAZOLE USP XX
5523 I V 9/12/1984 NATIONAL CANCER INSTITUTE MESNA:PRECLINICAL TOXICOLOGY &
PHARMACOLOGY STUDIES CONDUCTED FOR
NCI
5524 I III 7/12/1984 BESPAK DIV CONSORT MEDICAL PLC BESPAK BK 356 AEROSOL PHAR METERING
VALVES
5525 I II 8/29/1984 HAZER CHEMICALS INC SIMETHICONE USP (BULK FORM)
5526 I II 9/17/1984 KNOLL AG LUDWIGSHAFEN GALLOPAMIL HCl
5527 I II 9/14/1984 NOVO NORDISK AS HUMAN INSULIN (SEMI-SYNTHETIC) AS
PROCESSED IN KALUNDBORG & BAGSVAERD
5528 I II 9/13/1984 ROUSSELL UCLAF DESERPIDINE
5529 I II 9/13/1984 SIGMA F AND D DIV LTD HISTOPAQUE (1077 & 1119) & PHYSIOLOGICAL
SALTS MIXTURES PROC ST. LOUIS
5530 I II 9/21/1984 UPSHER SMITH LABS INC TROFAN (L-TYPTOPHAN)TABLETS & PLACEBO
5531 A II 7/23/1984 BROOKHAVEN NATIONAL LABORATORY STRONTIUM-82
5532 I III 9/20/1984 INNOVATION TECHNOLOGY INC COATING FORMULATIONS/HEAT SEAL COATED
MATERIALS PKG/LABEL,WARRINGTON
Page 168
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5533 I II 9/14/1984 NOVO NORDISK AS HUMAN INSULIN INJ NEUTRAL 500 UNITS/ML
PREPARED & PKG BAGSVAERD PLANT
5534 I II 9/18/1984 MITSUBISHI CORP L-CIS CIRAMADOL HYDROCHLORIDE(BULK
5535 I II 9/19/1984 DYNAMIT NOBEL AG NITROGLYCERINE 2.2% IN MIGLYOL(R)812
NEUTRAL AS PROC.IN LEVERKUSEN PLT
5536 I II 9/27/1984 PENCO OF LYNDHURST INC THEBAINE ALKABOID POWDER
5537 I V 9/25/1984 ROHM AND HAAS CO KATHON CG (KATHON 886):TOXICOLOGICAL
INFO. GENERATED TOX.DEPT,R-H CO.
5538 I IV 10/1/1984 GATTEFOSSE ESTABLISSEMENTS GELUCIRE 33/01,GELUCIRE 37/02,GELUCIRE
64/02
5539 I II 10/1/1984 SCHERING AG ROLIPRAM AS PRODUCED IN THE BERLIN
PLANT
5540 I II 10/12/1984 DSM PHARMA CHEMICALS SOUTH SALICYLSALICYLIC ACID
HAVEN INC
5541 I II 9/27/1984 BEN VENUE LABORATORIES INC CYCLOPHOSPHAMIDE LYOPHILIZED FOR INJ(5
DOSAGE FORMS)BEDFORD,OHIO FAC
5542 A II 9/27/1984 BWXT ITG CANADA INC INDIUM-111 CHLORIDE
5543 I II 9/12/1984 HOECHST CELANESE CORP CHLORZOXAZONE(BULK)
5544 I II 9/17/1984 EASTMAN KODAK CO RIBAVIRAN;VIREZOLE AS PREPARED IN THE
ROCHESTER,NEW YORK FACILITY
5545 A III 8/31/1984 HLG PACKAGING INC PHARMACEUTICAL HDPE BOTTLES
5546 I II 9/20/1984 DIOSYNTH BV GLUCAGON
5547 I II 10/2/1984 SELOC AG FUROSEMIDE
5548 I II 9/26/1984 KALI UND SALZ AG POTASSIUM CHLORIDE USP PRODUCED IN THE
HERINGEN (GERMANY) PLANT.
5549 I II 9/20/1984 YAMAMOTO CHEMICAL INDUSTRIES CO ACETAMINOPHEN USP XX
LTD
5550 I II 9/27/1984 JANSSEN PHARMACEUTICA NV LORCAINIDE HCL (JANSSEN CODE NO.R 15889
5551 I II 6/27/1984 NORDION CANADA INC STRONTIUM-82 CHLORIDE (SPALLATION)
5552 I II 9/17/1984 ORION CORP FARMOS CHEMICAL PLANT IBUPROFEN,200 MG TABLETS
Page 169
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5563 I III 6/18/1984 HAENDLER AND NATERMANN GMBH COMP & G PROC. FOR SINGLE LAYER TAB.
FOILS
5564 I II 10/4/1984 SELOC AG VERAPAMIL HYDROCHLORIDE
5565 I III 8/30/1984 BCL LTD COEXTRUDED POLYPROPYLENE FILM
5566 A II 9/28/1984 ORGAPHARM SAS THIOTHIXENE
5567 I I 10/10/1984 SUMMA MEDICAL CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ALBUQUERQUE, NEW MEXICO.
Page 174
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5698 I II 1/30/1985 BALL UNIMARK PLASTICS DIV BALL MANUFACTURING SITE, FACILITIES,
CORP PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MILROY, PA.
5699 I II 1/18/1985 ORCHIMIE SA (PRODUITS CHIMIQUES ET TRIFLUOPERAZINE
BIOCHIMIQUES)
5700 I III 2/11/1985 MONSANTO POLYMER PRODUCTS CO SANTOPRENE (R) THERMOPLASTIC
ELASTOMER,270 GRADE SERIES
5701 I II 2/13/1985 BEECHAM LABORATORIES DIV PROCESSING OF STERILE BULK CLAVULANATE
BEECHAM INC POTASSIUM
5702 I II 2/14/1985 FOREST LABORATORIES INC THIORIDAZINE HCL 400MG S.R.TABS (IN
SYNCHRON VEHICLE)
5703 I II 2/12/1985 SIEGFRIED AG BENZPHETAMINE HYDROCHLORIDE
5704 I II 1/30/1985 BALL UNIMARK PLASTICS DIV BALL MANUFACTURING SITE, FACILITIES,
CORP PERSONNEL,AND GENERAL OPERATING
PROCEDURES IN MILROY, PA. CENTER II.
5705 I II 2/4/1985 ZUMBRO INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES .
5706 I II 1/31/1985 SIMBEC RESEARCH LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
5707 I II 2/11/1985 GLAXO WELLCOME INC MANUFACTURING SITE AND FACILITIES FOR
ANNAN, UK PLANT
5708 I II 1/21/1985 GEDEON RICHTER PLC NORGESTIMATE
5709 I IV 2/11/1985 SUMITOMO CHEMICAL AMERICA INC EGG YOLK PHOSPHATIDE
5710 I II 1/30/1985 BALL UNIMARK PLASTICS DIV BALL MANUFACTURING SITE, FACILITIES,
CORP PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN GREENVILLE, SOUTH
CAROLINA, CENTER II.
5711 I IV 2/22/1985 FIRMENICH INC CHEMODERM 1001
5712 A III 2/19/1985 HUB PLASTICS INC BLOW MOLDED CONTAINER PRODUCTS
5713 A III 2/14/1985 BERRY GLOBAL INJECTION MOLDED/LINED CLOSURES
5714 I II 1/11/1985 PACKAGE CRAFT INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
5715 I II 2/11/1985 GLAXOCHEM LTD LABETALOL HYDROCHLORIDE
5716 I II 2/13/1985 IG SPRUHTECHNIK GMBH MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN WEHR/BADEN.
5717 A II 2/6/1985 FERMION OY DILTIAZEM HCL
5718 A IV 2/11/1985 GATTEFOSSE SAS TRANSCUTOL
5719 I III 2/15/1985 LABELTAPE MEDITECT INC TRANSDERMAL DRUG DELIVERY SYSTEM
5720 I II 2/25/1985 SIEGFRIED AG HYDRALAZINE HYDROCHLORIDE
5721 I II 2/19/1985 BACHEM FINE CHEMICALS INC GROWTH HORMONE RELEASING FACTOR
(GRF),(1-44)AMIDE,HUMAN (BULK)
Page 175
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5722 A II 2/22/1985 ALBEMARLE CORP ORPHENADRINE CITRATE USP
5723 I II 2/27/1985 PFIZER INC ZINC GLUCONATE
5724 I II 2/14/1985 PROCOS SPA DISOPYRAMIDE PHOSPHATE
5725 I II 12/3/1984 RECORDATI INDUSTRIA CHIMICA E ALPHA-METHYLDOPA
FARMACEUTICA SPA
5726 I II 2/4/1985 KLINGE PHARMA CO DIPIVEFRINE HCL.
5727 I II 2/7/1985 CONTAINER SUPPLY CO MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
5728 I II 3/6/1985 CHEMISCHE WERKE LAHR GMBH CROTAMITON
5729 I II 3/4/1985 QUALITY CHEMICALS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN TYRONE, PA.
5730 I II 3/5/1985 ROUSSELL UCLAF DIHYDROTACHYSTEROL
5731 I II 3/5/1985 ACME UNITED CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
5732 I II 2/28/1985 GEDEON RICHTER LTD DISOPYRAMIDE PHOSPHATE
5733 I II 2/26/1985 SANDOZ PHARMACEUTICALS CORP DIV PHENIRAMINE MALEATE
SANDOZ INC
5734 A IV 2/28/1985 GATTEFOSSE SAS LABRASOL, LABRAFAC HYDRO WL 1219
5735 I II 2/27/1985 SERONO LABORATORIES INC VIA CASILINA PLANT IN ROME, ITALY
5736 I II 3/5/1985 PARKE DAVIS DIV WARNER LAMBERT MANUFACTURING SITE, FACILITIES,
CO PERSONNEL, AND GENERAL OPERATING
PROCEDURES
5737 I II 2/12/1985 RP SCHERER NORTH AMERICA DIV RP ENPROSTIL CAPSULES
SCHERER CORP
5738 I II 3/1/1985 TRINITY TECHNOLOGIES CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN DETROIT, MICHIGAN.
5739 I II 3/13/1985 EVONIK TECHNOCHEMIE GMBH GUANABENZ ACETATE
5740 A II 2/27/1985 CHEMICAL WORKS OF GEDEON ETHINYL ESTRADIOL USP
RICHTER PLC DBA GEDEON RICHTER
PLC
5741 I II 3/11/1985 PROFARMACO SRL MECLOFENAMATE SODIUM
5742 I II 8/17/1984 ELI LILLY INDUSTRIES INC ALMITRINE BISMESYLATE TABLETS
5743 I II 3/11/1985 LEDERLE LABORATORIES DIV MANUFACTURING SITE, FACILITIES,
AMERICAN CYANAMID CO PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BOUND BROOK, NEW JERSEY.
Page 176
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5747 I II 3/13/1985 SANDOZ LTD PHARMACEUTICAL DIV LORAZEPAM
CHEMICAL DEVELOPMENT
5748 A II 3/11/1985 SIEGFRIED EVIONNAZ SA METOLAZONE
5749 I II 3/4/1985 MICROCHEM LABORATORIES IRELAND CONTRACT MICRONIZATION SERVICES
LTD LOCATED IN FIORENZUOLA D'ARDA, ITALY
5750 I II 3/11/1985 DIOSYNTH INC PREGNANT MARE SERUM GONADOTROPIN
(PMSG)(CRUDE)
5751 A IV 3/21/1985 VIRGINIA DARE EXTRACT CO INC EXTRACTS & FLAVORS
5752 I I 3/18/1985 CP PACKAGING INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN JAMESBURG, NEW JERSEY.
5753 I II 3/27/1954 BOEHRINGER INGELHEIM PHARMA KG CAFFEINE AS PROCESSED IN INGELHEIM
FACILITIES
5754 I II 3/20/1985 CILAG CHEMIE AG DISULFIRAM
5755 I I 2/27/1985 SHIONOGI QUALICAPS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES
5756 I II 3/29/1985 LUDWIG HEUMANN AND CO GMBH METOCLOPRAMIDE HCL.
5757 I II 2/19/1985 MCNEIL CONSUMER HEALTHCARE DIV NICOTINE RESIN COMPLEX 20%
MCNEIL-PPC INC
5758 I II 2/18/1985 NOVO NORDISK AS PRODUCTION OF INSULIN
5759 I II 2/18/1985 DOW CHEMICAL CO CHOLESTYRAMINE USP
5760 I II 3/18/1985 PLAISTOW LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN LITTLE ISLAND, COUNTY
CORK.
5761 I II 3/19/1985 LYPHOMED INC ISOSORBIDE DINITRATE INJECTION (50ML AND
100ML)
5762 I V 2/28/1985 SQUIBB DIAGNOSTICS RUBIDIUM-82 PERCLINICAL STUDIES
5763 I II 3/28/1985 ORTHO DIAGNOSTIC SYSTEMS DIV PHOTOFRIN
ORTHO PHARMACEUTICAL LTD
5764 I II 11/30/1984 TEXBERRY CONTAINER CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
5765 I II 3/27/1985 BOEHRINGER INGELHEIM PHARMA ERGOTAMINE TARTRATE
GMBH AND CO KG
5766 I II 3/15/1985 INJECTRONICS INC MANUFACTURING SITE FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BURLINGTON, NORTH
CAROLINA.
5767 A V 3/27/1985 STERIS CONTRACT STERILIZATION FACILITY IN SANDY,
UTAH
5768 I II 2/28/1985 SQUIBB DIAGNOSTICS MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
Page 177
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5769 I IV 3/7/1985 EKA NOBEL INC PAPER CHEMICALS DIV BEROCELLS 584 AND 588
5770 I IV 4/8/1985 SMITH KLINE & FRENCH LABS DIV EMPTY HARD GELATIN CAPSULES
SMITHKLINE BECKMAN CORP
5771 I II 4/1/1985 DELTA SYNTHETIC CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN TAIPEI HSIEN, CHINA.
5772 I II 4/1/1985 DOW CHEMICAL CO ETHYCELLULOSE DISPERSIONS
5773 I II 3/27/1985 NV ORGANON DROPERIDOL
5774 I I 4/3/1985 MASTER-PAK LABORATORIES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PATERSON, NEW JERSEY.
5775 I II 3/21/1985 NORAMCO DELAWARE INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN WILMINGTON, DELAWARE.
5776 I II 3/8/1985 FABBRICA ITALIANA SINTETICI SPA PRAZEPAM
5777 I II 4/9/1985 ORION CORP FARMOS CHEMICAL PLANT TAMOXIFEN (10MG. TABLET)
Page 183
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5935 I II 7/15/1985 MISSION PHARMACAL CO MANUFACTURING SITE, FACILITIES,
PERSONNEL,AND GENERAL OPERATING
PROCEDURES IN SAN ANTIONIO, TEXAS.
5936 I II 7/18/1985 DOW CHEMICAL CO MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PITTSBURG, CAL.
5937 I II 5/31/1985 KOTHARI PHYTOCHEMICALS PROPRANOLOL HYDROCHLORIDE
INTERNATIONAL
5938 I II 7/16/1985 NYPRO INC COMBINATION I & III FOR INJECTION MOLDED
MATERIALS
5939 I II 7/26/1985 ORCHIMIE SA (PRODUITS CHIMIQUES ET THIOTHIXENE DIHYDROCHLORIDE ANHYDROUS
BIOCHIMIQUES)
5940 I II 7/25/1985 HOECHST AG ANTIPYRINE
5941 I II 6/26/1985 AMERICAN CHEMICAL INDUSTRIAL PROCHLORPERAZINE EDISYLATE USP XXI
CORP
5942 I II 7/24/1985 PHARM ECO LABORATORIES INC D,L,N,-BENZYL-ALPHA-
ACETOXPHENYLACETAMIDE (BPA)
5943 I II 4/26/1985 3M PHARMACEUTICALS MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN RAMAT-GAN, ISRAEL.
5944 I II 7/17/1985 SANDOZ LTD PHARMACEUTICAL DIV 6-METHYLERGOLINE-8B-CARBOXYLIC ACID
CHEMICAL DEVELOPMENT
5945 I II 8/5/1985 DIOSYNTH BV MIANSERIN HYDROCHLORIDE
5946 A III 8/2/1985 CATTY CORP A COMBO.S I/III PROD.VINYL HEATSEALABLE
ALUM.FOILS
5947 I II 8/6/1985 RHONE-POULENC SANTE INC TRIMEPRAZINE TARTRATE
5948 I II 8/7/1985 WYCKOFF CHEMICAL CO INC PRILOCAINE HYDROCHLORIDE USP
5949 I II 8/6/1985 INVAMED INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN FAIRFIELD, NEW JERSEY.
5950 I II 7/30/1985 FMC CORP TETRAPOTASSIUM PEROXYDIPHOSPHATE
5951 A II 8/9/1985 MERCK SANTE SAS METFORMIN HYDROCHLORIDE
5952 I II 8/14/1985 SANKYO CO LTD CEFMETAZOLE SODIUM INJECTION(VIALS)
5953 I II 6/26/1985 PENINSULA LABS INC ALPHA-ATRIAL NATRIURETIC PEPTIDE (HUMAN
1-28)
5954 A II 7/9/1985 BOEHRINGER INGELHEIM CHEMICALS METHOCARBAMOL
INC
5955 I III 7/25/1985 NATIONAL STARCH AND CHEMICAL CO PRESSURE SENSITIVE ADHESIVES FOR
TRANSDERMAL MEDICAL APPLICATION
5956 I II 7/16/1985 NYPRO INC INJECTION MOLDED MATERIALS
5957 I III 7/31/1985 VICTOR TUBE CORP PRODUCTION OF COLLAPSIBLE TUBES IN
HARRISSONBURY,VA.
5958 I II 8/15/1985 KV PHARMACEUTICAL CO CAPTOPRIL TABLETS, 100MG.
5959 I II 8/9/1985 LIPHA SAS METFORMIN ( LA-6023),500MG.&850MG.
TABLETS
Page 184
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
5960 I I 7/30/1985 FREEDOM CHEMICAL DIAMALT GMBH MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN RAUBLING (FRG).
5961 I II 8/27/1985 FMC CORP CELLULOSE TRIACETATE
5962 I II 8/16/1985 SOCIETE INDUSTRIELLE DES SEMI-SYNTHETIC GLYCERIDES
OLEAGINEUX
5963 I II 8/8/1985 PAR PHARMACEUTICAL INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SPRING VALLEY, NEW YORK.
5964 I II 8/7/1985 CALIFORNIA BIOTECHNOLOGY INC NAZDEL TM MEMBRANE PERMEATION
ENHANCER
5965 I II 8/26/1985 GLAXOCHEM LTD O/4 DIHYDROCHLORIDE DIHYRATE (CPZ ROUTE)
6037 I II 10/4/1985 DM GRAHAM LABORATORIES INC IBUPROFEN TIMED-RELEASE 600 MG. TALBETS
6038 I II 10/9/1985 SHOWA DENKO KK GYLCINE
6039 I II 10/1/1985 SMITHKLINE AND BECKMAN INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CIDRA, PUERTO RICO.
6040 I III 9/27/1985 ISRAEL CAN CO LTD PROD.FLEXIBLE PKG.MATERIAL (KFAR SABA
PLANT)
6041 I I 5/31/1985 CARLSBERG BIOTECHNOLOGY LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL,AND GENERAL OPERATING
PROCEDURES IN COPENHAGEN, DENMARK.
6042 I II 9/16/1985 BACHEM FINE CHEMICALS INC ATRIAL NATRIURETIC PEPTIDE (4-28).HUMAN
6043 I II 7/10/1985 PHARMACIA AND UPJOHN AB MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN UPPSALA, SWEDEN.
6044 I II 10/1/1985 BOEHRINGER INGELHEIM CHEMICALS GLYCOPYRROLATE
INC
6045 I II 9/30/1985 SMITHKLINE AND BECKMAN INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CIDRA, PUERTO RICO.
Page 187
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6046 I II 10/7/1985 GEDEON RICHTER LTD RGH-4417
6047 I II 9/26/1985 GIULIANI SPA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CERNUSCO SUL NAVIGLIO.
6048 I II 9/27/1985 NIPPON KAYAKU CO LTD SUCRALFATE
6049 I II 5/31/1985 CARLSBERG BIOTECHNOLOGY LTD NAFARELIN ACETATE
6050 I I 10/7/1985 BIOCHEMIC GESELLSCHAFT MBH MANUFACTURING SITE, FACILITY, PERSONNEL
AND GENERAL OPERATING PROCEDURES IN
KUNDL, AUSTRIA
6051 I IV 10/7/1985 PHARMACIA AND UPJOHN AB SEPHAROSE GEL FILTRATION MEDIA
6052 I II 10/7/1985 FUJISAWA PHARMACEUTICAL CO LTD NILVADIPINE (FK 235,FR 34235)
6053 I II 10/2/1985 ASAHI CHEMICAL INDUSTRY CO LTD EGG PHOSPHATIDYLCHOLINE
6054 I I 10/11/1985 CHELSEA LABORATORIES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN LAKEVIEW, NEW YORK.
6055 I II 9/24/1985 ABBOTT LABORATORIES HYDROCHLOROTHIAZIDE
PHARMACEUTICAL PRODUCTS DIV
6056 I II 10/2/1985 INTERPHARM INC FOR PLAINVIEW,N.Y.
6057 I II 9/5/1985 SHANGHAI NO 6 PHARMACEUTICAL SUCRALFATE
FACTORY
6058 I II 8/16/1985 MITSUBISHI YUKA FINE CHEMICALS CO ZPT SLURRY
LTD
6059 I III 10/1/1985 COMAR INC GLASS PACKAGING MATERIALS
6060 I II 10/11/1985 PHARMACIA AND UPJOHN AB MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF LARGE VOLUME
PARENTERALS IN GLASS BOTTLES IN UPPSALS,
SWEDEN.
6061 I I 9/19/1985 ORTHO DIAGNOSTIC SYSTEMS DIV MANUFACTURING SITE, FACILITIES,
ORTHO PHARMACEUTICAL LTD PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN DON MILLS, ONTARIO.
6062 I II 9/25/1985 NIPPON KAYAKU CO LTD AMINO ACID
6063 I II 9/30/1985 BASF PLC BTS 54 524
6064 I II 10/17/1985 HALDANE CONSULTANTS LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN POOLE, DORSET (ENGLAND),
NUFFIELD ROAD.
6065 A II 10/16/1985 PHARMACIA AND UPJOHN SUB PFIZER EPOPROSTENOL SODIUM (U-53,217A)
INC
6066 I II 10/8/1985 SCIENTIFIC POLYMER PRODUCTS INC POLY (2-HYDROXYETHYL METHACAYLATE)
6067 I II 10/3/1985 GLATT AIR TECHNIQUES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN RAMSEY, NEW JERSEY.
6068 I I 9/30/1985 ALDRICH CHEMICAL CO INC 4-METHYLPYAZOLE
Page 188
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6069 I II 10/11/1985 BIOMED LABORATORIES MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SAN DIMAS, CALIFORNIA.
6070 I II 10/21/1985 BOEHRINGER INGELHEIM CHEMICALS METOCLOPRAMIDE
INC
6071 I II 10/7/1985 GEDEON RICHTER LTD DIAZEPAM USP
6072 I II 6/18/1985 KONOSHIMA CHEMICAL CO LTD MAGNESIUM OXIDE
6073 I I 9/11/1985 BEECHAM LABORATORIES DIV OF MANUFACTURING SITE, FACILITIES,
BEECHAM INC PERSONNEL, AND GENERAL OPERAING
PROCEDURES IN MAYENNE, FRANCE.
6074 A IV 10/18/1985 GATTEFOSSE SAS TEFOSE 1500, POLYSTATE B, POLYSTATE C,
STEARATE 1500, STEARATE 4000,
SUPERPOLYSTATE
6075 I II 7/2/1985 NEWPORT PHARMACEUTICALS ISOPRINOSINE SYRUP 5%
INTERNATIONAL INC
6076 I I 9/27/1985 WICKHAM RESEARCH LABORATORIES WICKHAM, HAMPSHIRE FACILITIES ON
LTD WINCHESTER RD.
6077 I IV 10/15/1985 INTERNATIONAL SPECIALTY PRODUCTS M-PYROL (N-METHYLPYRROLIDONE)
6078 I II 9/30/1985 MEDI NUCLEAR CORP INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BALDWIN PARK, CA.
6079 I II 10/21/1985 JANSSEN PHARMACEUTICA NV LEVAMISOLE HCL-R 12564
6080 I II 8/6/1985 HANGZHOU MINSHENG THEOPHYLLIN
PHARMACEUTICAL FACTORY
6081 I II 9/26/1985 ALTANA LOMBERG CHEMISCHE FABRIK BUDIPINE-HYDROCHLORIDE
6082 A II 11/6/1985 ADARE PHARMACEUTICALS INC ACETAMINOPHEN, MICROENCAPSULATED
6083 I I 11/4/1985 BEECHAM LABORATORIES DIV OF BLOW MOLDING FACILITY IN BRISTOL,TN.
BEECHAM INC
6084 I II 11/4/1985 COMPANIA ESPANOLA DE SINTESIS BECLOMETHASONE DIPROPIONATE USP
QUIMICA SA
6085 I II 11/7/1985 OTSUKA PHARMACEUTICAL CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN TOKUSHIMA, JAPAN.
6086 I II 10/25/1985 RHONE POULENC RORER SPIRAMYCIN BASE
PHARMACEUTICALS INC
6087 I II 10/29/1985 VICKS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CAYEY, PUERTO RICO.
6088 I II 11/8/1985 MATRIX RESEARCH LABORATORIES INC AL-721
6089 I II 11/13/1985 MIKART INC ACETAMINOPHEN & CODEINE PHOSPHATE
TABS. 650/60
6090 I II 11/12/1985 ELI LILLY INDUSTRIES INC CEPHALEXIN HYDROCHLORIDE,BULK
6091 I II 11/7/1985 OTSUKA PHARMACEUTICAL CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN TOKUSHIMA, JAPAN.
Page 189
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6092 I II 11/13/1985 ORGAMOL SA TRILOSTANE
6093 I III 10/9/1985 WEST PHARMACEUTICAL SERVICES INC PLASTIC INJECTION MOLDED CLOSURES
Page 191
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6143 I II 1/4/1985 LABORATORIO CHIMICO SALBUTAMOL BASE AND SALBUTAMOL SULFATE
INTERNAZIONALE SPA (ALBUTEROL BASE ETC.)
6144 I II 11/1/1985 LONZA INC TOLRESTAT AND ITS INTERMEDIATES
6145 I II 12/9/1985 ELAN CORP PLC PARACETAMOL (ACETOMINOPHEN) ORAL LA
SUSPENSION
6146 I III 1/2/1986 ELI LILLY INDUSTRIES INC QUALITY CONTROL PROCEDURES FOR IN-
COMING INSPECTION OF PACKAGING
COMPONENTS USED IN PUERTO RICO
6147 I I 1/13/1986 S-P PRODUCTS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES S-P PRODUCTS, INC.
6148 A II 12/23/1985 SIGMA ALDRICH MANUFACTURING LLC TRIPALMITIN
6149 I III 12/6/1985 ADVANCED ELASTOMER SYSTEMS SANTOPRENE THERMOPLASTIC ELASTOMER
GRADE 271-64-W144
6150 I II 1/7/1986 DSM ANDENO GMBH SILVER SULFADIAZINE
6151 A III 11/11/1985 AXIALL CORP POLYVINYL CHLORIDE PRODUCTS
6152 I II 2/15/1983 BOEHRINGER INGELHEIM PHARMA SCOPOLAMINE HYDROBROMIDE
GMBH AND CO KG
6153 I II 1/2/1986 SIGMA F AND D DIV LTD NALOXONE HCL.AS RELABELLED FOR SIGMA
6154 I II 12/17/1985 ALDRICH CHEMICAL CO INC TERT-BUTYL METHYL ETHER
6155 I II 12/20/1985 MALLINCKRODT CHEMICAL INC PROPOXYPHENE HYDROCHLORIDE
6156 I II 1/13/1986 WYETH-AYERST LABORATORIES MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ENGLAND.
6157 I II 12/19/1985 MAY AND BAKER LTD PROMAZINE HYDROCHLORIDE
6158 I II 12/19/1985 FREEDOM CHEMICAL DIAMALT GMBH URSODEOXYCHOLIC ACID
6159 A II 12/30/1985 CAMBREX PROFARMACO MILANO SRL CHLORDIAZEPOXIDE
6160 I II 12/26/1985 SIGMA F AND D DIV LTD POLYETHYLENE GLYCOL
6161 I II 11/4/1985 EVANS MEDICAL LTD DIAMOPHINE HYDROCHLORIDE
6162 I II 1/13/1986 WYETH-AYERST LABORATORIES TEMAZEPAM
6163 I II 11/21/1985 ETHYL CORP TOLRESTAT
6164 I II 10/3/1985 BIOCON BIOCHEMICALS LTD SODIUM HEPARIN
6165 I II 12/30/1985 ABBOTT LABORATORIES GONADORELIN DIACETATE TETRAHYDRATE
PHARMACEUTICAL PRODUCTS DIV (GnRH)
6166 I II 1/10/1986 BAYER AG EDRUL TABS (20,30 & 240MG)
6167 I II 1/3/1986 FUJI CHEMICAL INDUSTRY CO LTD KB-2413,1-(2-ETHOXYETHYL)-2-(4-METHYL-I-
HOMOPIPERAZINYL)BENZIMIDAZOLE
6168 I II 1/20/1986 MATERIALS PROCESSING TECHNOLOGY ACETAMINOPHEN,73% GRANULATION
INC
6169 I II 1/23/1986 ORGAMOL SA MINAPRINE
6170 A II 1/24/1985 PMC ISOCHEM ACETOHYDROXAMIC ACID
6171 I II 1/14/1986 DELMAR CHEMICALS INC N-[,3-5-DI(PYROLIDNYLMETHYL)-4-
HYDROXY]BENZOYL ANILINE(A.CC.-9358)
6172 I II 1/10/1986 BAYER AG MUZOLIMINE SEMIHYDRATE
6173 I II 1/3/1986 ORION CORP LTD RITODRINE HCL
Page 192
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6174 A II 12/19/1985 BAYER AG GESTODENE
6175 I II 1/27/1986 LEIRAS PHARMACEUTICALS LEVONORGESTREL INTRAUTERINE DEVICE
6176 I II 12/10/1985 PALMER RESEARCH MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN HOLYWELL, WALES, UNITED
KINGDOM.
6177 I III 1/29/1986 HOOVER UNIVERSAL INC POLYETHYLENE TEREPHTHALATE (PET)
BOTTLES
6178 I II 1/23/1986 ROUSSELL UCLAF TRIPROLIDINE HCL.
6179 I II 5/30/1985 ISOCHEM SA 1-METHYL AMINO-1-METHYL-THIO-2-
NITROETHYLENE AND
6180 I II 12/27/1985 3M PHARMACEUTICALS MANUFACTURE AND ASSEMBLY FACILITIES
6181 I II 1/17/1986 MERCK AND CO INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN HOBBESDON,
HERFORDSHIRE, ENGLAND.
6182 I II 2/7/1986 CULTOR FOOD SCIENCE INC CAFFEINE
6183 I II 2/6/1986 HEUMANN PCS GMBH PRAZOSIN HYDROCHLORIDE
6184 I II 2/4/1986 ELAN CORP PLC THEOPHYLLINE PHARMAZOME TM POWDER
6185 I II 1/30/1986 SOCIETA ITALIANA CORTICOSTEROIDI HYDROCORTISONE HEMISUCCINATE
SPA
6186 I II 1/29/1986 PARKE DAVIS DIV WARNER LAMBERT N-ACETYLPROCAINAMIDE HCL.
CO
6187 A II 2/11/1986 FIS FABBRICA ITALIANA SINTETICI SPA SULINDAC
6188 I II 2/11/1986 ABBOTT LABORATORIES ETHRANE (ENFLURANE)
PHARMACEUTICAL PRODUCTS DIV
6189 I II 1/30/1986 ORION CORP LTD BENZTROPINE MESYLATE
6190 I II 2/4/1986 ELAN CORP PLC IBUPROFEN CAPSULES
6191 I II 2/22/1986 DINAMITE DIPHARMA SPA D-OXYPHENE
6192 I II 1/17/1986 ZAMBON SPA THIAMPHENICOL
6193 I II 2/3/1986 GANES CHEMICALS INC PENNSVILLE EPHEDRINE HYDROCHLORIDE
6194 I II 1/30/1986 SIGMA F AND D DIV LTD DELTA-AMINOLEVULINIC ACID HCL
6195 I III 1/25/1986 PACKAGING COORDINATORS INC PCI CARIBE,INC.FACILITY,GURABO,PUERTO
RICO
6196 I II 2/12/1986 CP PHIBROCHEM DIV PHILIPP GUAIFENSEIN USP
BROTHERS CHEMICALS INC
6197 A II 12/3/1985 TEVA PHARMACEUTICAL INDUSTRIES NIFEDIPINE
LTD
6198 I II 1/21/1986 KOTHARI PHYTOCHEMICALS CHLORPROPAMIDE AND TOLBUTAMIDE
INTERNATIONAL
6199 I II 12/20/1985 SAN FU CHEMICAL CO LTD MANNITOL
6200 I II 2/12/1986 ABBOTT LABORATORIES HALOPERIDOL
PHARMACEUTICAL PRODUCTS DIV
6201 I II 2/11/1986 SIGMA F AND D DIV LTD DEOXYCHOLIC ACID,SODIUM SALT
Page 193
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6202 I III 2/22/1986 BEMIS CO INC PRODUCTION OF DRUG PACKAGING MATERIALS
IN MURPHUSBORO, IL
6203 I II 11/12/1985 BERKELEY ANTIBODY CO IMMUNOLOGICAL SERVICES AS RELATED TO
VITRO QUALITY ASSURANCE
6204 I II 1/10/1986 GEDEON RICHTER LTD DISOPYRAMIDE PHOSPHATE CAPSULES
6205 I III 2/17/1986 B BRAUN MEDICAL INC MCGAW TM PLASTIC CONTAINER
6206 I II 2/21/1986 BRACCO IND CHIMICA SPA IOTHALAMIC ACID
6207 I II 2/21/1986 MIKART INC ACETAMINOPHEN AND HYDROCODONE
BITARTRATE
6208 I II 1/16/1986 CHINOIN PHARMACEUTCIAL AND VERAPAMIL HYDROCHLORIDE
CHEMICAL WORKS CO LTD
6209 I II 12/9/1985 BIOCON BIOCHEMICALS LTD PAPAIN
6210 I II 3/4/1986 ELAN CORP PLC IBUPROFEN 300MG. LA CAPSULES
6211 I II 3/3/1986 RP SCHERER LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
6212 I II 2/7/1986 STERIS LABORATORIES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN WEST BETHANY, ARIZONA.
6213 A II 3/5/1986 TEVA PHARMACEUTICAL INDUSTRIES ATENOLOL
LTD
6214 I III 3/4/1986 MID-STATE PLASTICS, INC. INJECTION MOLDED PARTS IN SEAGROVE,
NORTH CAROLINA
6215 A II 1/23/1986 ASAHI KASEI FINECHEM CO LTD CYTARABINE
6216 A II 2/20/1986 SIGMA ALDRICH MANUFACTURING LLC PALMITIC ACID
6217 A II 2/25/1986 JOHNSON MATTHEY PHARMACEUTICAL FENTANYL BASE
MATERIALS
6218 I III 3/12/1986 REXAM MEDICAL PACKAGING INC HEAT SEALABLE AND PEELABLE ADHESIVE
COATINGS
6219 I III 2/11/1986 PALMYRA NONWOVENS CORP FIBROUS RAYON PHARMACEUTICAL COILS
6220 I II 3/7/1986 EASTMAN KODAK CO MEROCYANINE 540
6221 I II 2/17/1986 CHEMWERTH INC VINCRISTINE SULFATE
6222 I II 2/20/1986 BALENCO ENTERPRISES INC DECYLMETHYL SULFOXIDE USP
6223 I II 12/16/1985 FABBRICA ITALIANA SINTETICI SPA TRIMETHOPRIM AF (ANILINE FREE)
6224 I II 2/27/1986 FINE CHEMICALS CORP MECLOFENAMATE SODIUM
6225 I II 2/20/1986 BIOTEK INC LEVONORGESTREL MICROCAPSULES
6226 I II 9/6/1985 PFIZER LABORATORIES DIV PFIZER INC TINIDAZOLE
6227 I II 2/26/1986 ROUSSELL UCLAF DISOPYRAMIDE PHOSPHATE
6228 I III 12/4/1985 DUPONT POLYESTER CARODEL POLYETHYLENE TEREPHTHALATE
(PET) RESINS X5122
6229 I IV 2/18/1986 BRASKAP INDUSTRIA E COMERCIO LTDA EMPTY HARD GELATIN CAPSULES
6386 I II 5/15/1986 ALDRICH CHEMICAL CO INC FILLING & FREEZE DRYING METHODS FOR IN-
VIVO MATERIAL
6387 I II 5/9/1986 SALK INSTITUTE NAL-GLU ANTAGONIST AS RESEARCHED IN SAN
DIEGO, CALIFORNIA
6388 I II 2/21/1986 NV ORGANON NALBUFINE HYDROCHLORIDE
6389 I II 8/6/1985 ORION CORP LTD METHOCARBAMOL
6390 I II 6/4/1986 FINE CHEMICALS CORP DANAZOL USP
6391 A II 5/9/1986 DIPHARMA FRANCIS SRL BENDROFLUMETHIAZIDE USP
6392 I II 5/30/1986 PHARMACIA AND UPJOHN AB MANUFACTURING SITE, FACILITIES, OPERATING
PROCEDURES AND PERSONNEL IN UPPSALA,
SWEDEN.
6393 I II 6/4/1986 HYBRITECH INC INDIUM-III CITRATE ANTIBODY GRADE 7590
6394 I II 12/17/1982 DINAMITE DIPHARMA SPA TOLAZAMIDE
6395 I II 6/2/1986 SIGMA F AND D DIV LTD ESERINE SALICYLATE SALT
6396 I II 6/6/1986 GANES CHEMICALS INC PENNSVILLE TRAZODONE HYDROCHLORIDE
6397 I I 6/9/1986 MEDICAL UNIV OF SOUTH CAROLINA MANUFACTURING SITE, FACILITIES,
HOSP PHARMACY PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CHARLESTON, SOUTH
CAROLINA.
6398 I II 8/1/1985 PHARM ECO LABORATORIES INC CYCLOPHOSPHAMIDE MONOHYDRATE
6399 I II 6/4/1986 PHARM ECO LABORATORIES INC HALOPROGIN
6400 I I 6/5/1986 HOFFMANN LAROCHE MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN VILLIAGE-NEUF, FRANCE.
6401 I II 6/3/1986 EASTMAN KODAK CO 1-METHYL-2-(3-PYRIDYL) PYRROLIDINE
(NICOTINE)
6402 I II 6/10/1986 FINE ORGANICS LTD 1, METHYLAMINO-1-METHYLTHIO-2-
NITROETHENE
6403 I II 6/2/1986 HEICO CHEMICALS DIV WHITTAKER POTASSIUM BICARBONATE, USP
CORP
6404 I II 6/2/1986 HEICO CHEMICALS DIV WHITTAKER PSEUDOEPHEDRINE HCL USP
CORP
6405 I II 6/9/1986 PFIZER INC BETAMETHASONE VALERATE
6406 I III 6/11/1986 CONSOLIDATED CONTAINER CO LLC POLYETHYLENE AND POLYPROPYLENE
CONTAINERS
6407 I II 6/15/1982 TENNECO CHEMICALS INC NUOPLAZ 6959 (PLASTICIZER)
6408 I III 5/28/1986 INTERTECH CORP PLASTIC BOTTLE CONTAINERS
6409 I II 6/5/1986 NV ORGANON FLUPHENAZINE DECANOATE
6410 I II 6/10/1986 JRS PHARMA LP MICROCRYSTALLINE CELLULOSE USP
Page 200
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6411 I II 6/12/1986 MERCK KGAA TITRIPLEX VS,
DIETHYLENETRIAMINEPENTAACETIC ACID
6412 A II 6/12/1986 PCAS OXYBUTYNIN CHLORIDE USP
6413 A II 6/6/1986 NORAMCO INC CODEINE PHOSPHATE
6414 I II 6/9/1986 RECKITT AND COLMAN PRODUCTS LTD IDAZOXAN CAPSULES
PHARMACEUTICAL DIV
6415 I II 6/12/1986 RECKITT AND COLMAN PRODUCTS LTD IDAZOXAN DRUG SUBSTANCE
PHARMACEUTICAL DIV
6416 I I 6/10/1986 HOFFMANN LAROCHE F AND CO LTD MANUFACTURING FACILITY LOCATED IN BASLE,
SWITZERLAND
6417 I III 4/25/1986 ABBOTT LABORATORIES HOSP FC85 PLASTIC (FLEXIBLE CONTAINERS)
PRODUCTS DIV
6418 I II 6/2/1986 CYCLO PRODUCTS INC BUSPIRONE HYDROCHLORIDE
6419 I III 7/1/1985 HELVOET PHARMA NV RUBBER CLOSURES
6420 I II 6/5/1986 NEN LIFE SCIENCE PRODUCTS IONIC GALLIUM-68
6421 A II 6/18/1986 FINE CHEMICALS CORP PTY LTD BACLOFEN
6422 I II 6/11/1986 LABORATORY ANALYTICAL BIOLOGY INC ERGOTAMINE IN HUMAN PLASMA
6423 I II 5/16/1986 SMITH KLINE & FRENCH LABS DIV CARBON-14 ALBENDAZOLE SUSPENSION
SMITHKLINE BECKMAN CORP
6424 I III 2/28/1986 GETTIG PHARMACEUTICAL RUBBER CLOSURE FORMULATION, GP 1502/45
INSTRUMENT CO
6425 I II 6/11/1986 SANOFI PHARMACEUTICALS INC CHLOROQUINE BASE AND PHOSPHATE
6426 A V 6/12/1986 STERIGENICS US LLC STERILE FINISHED PRODUCTS AND STERILE
PROCESSING OPERATIONS
6427 I I 6/13/1986 DAINIPPON PHARMACEUTICAL CO LTD FACILITIES, PERSONNEL, AND PROCEDURES AT
SUZUKA-SHI, JAPAN
6428 A II 6/18/1986 KATWIJK CHEMIE BV VALPROIC ACID
6429 I II 6/9/1986 OLIN RESCTR OMADINE MDS
6430 I II 6/17/1986 DC CHEMICAL CO LTD HEXACHLOROPHENE
6431 I II 6/19/1986 CARLSBERG BIOTECHNOLOGY LTD IGE PENTAPEPTIDE ACETATE
6432 I II 6/17/1986 STEROID STABILIMENTS OXYMETHOLONE USP
6433 I II 6/17/1986 STEROID SRL STANOZOLOL USP
6434 I II 1/9/1984 HOFFMANN LA ROCHE INC PROTIRELIN (THYROTROPIN RELEASING
HORMONE)
6435 I II 6/18/1986 SIGMA F AND D DIV LTD FRUCTOSE 1,6-DIPHOSPHATE
6436 I II 6/25/1986 SOLVAY PHARMACEUTICALS HORMONE G. FACILITY LOCATED IN BAUDETTE,
MINNESOTA
6437 I II 6/18/1986 HONEYMEAD PRODUCTS CO EDIBLE LIQUID SOYBEAN OIL
6438 I II 6/25/1986 SUMIKA FINE CHEMICALS CO LTD METOLAZONE
6439 I II 6/23/1986 DINAMITE DIPHARMA SPA SULINDAC USP
6440 A II 6/27/1986 BWXT ITG CANADA INC SODIUM IODIDE I-123
6441 I III 6/26/1986 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMULATION B5000-45
GRAY
Page 201
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6442 I III 6/26/1986 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMULATION B5000-55
GRAY
6443 I II 6/23/1986 PHARMACIA AND UPJOHN OLSALAZINE SODIUM
6444 I II 6/26/1986 NORDEN ANDBRO MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PITMAN, NEW JERSEY.
6445 I II 6/27/1986 WYETH-AYERST LABORATORIES OXAZEPAM
6446 I III 6/11/1986 SOLVAY AND CIE SA BENVIC EB 652/5405-A, RIGID PVC COMPOUND
6447 I II 7/2/1986 MACFARLAN SMITH JOHNSON MATTHEY PENTAMIDINE ISETHIONATE,(BULK)
PLC BUSINESS
6448 I V 6/10/1986 HOLOPAK GMBH ASEPTIC PROCESSING FACILITY FOR
ROMMELAG(R) BOTTELPACK(R) BLOW-FILL-
SEAL TECHNOLOGY IN SULZBACH AND
UNTERGRONINGEN, GERMANY
6449 I II 7/2/1986 AMERSHAM INTERNATIONAL PLC YTTRIUM 90Y SILICATE
AMERSHAM LABORATORY
6450 I II 6/25/1986 STEROID SRL FACILITIES,PERSONNEL,AND OPERATING PROC.
AT COLOGNO MONZESE,IT
6451 I II 4/24/1986 SIGMA F AND D DIV LTD BETA-PHENYLETHYLAMINE HYDROCHLORIDE
6452 I II 7/2/1986 RHONE-POULENC SANTE INC ALLOPURINOL
6453 I III 5/14/1986 DRG MEDICAL PACKAGING INC 2438 COATING PAPER
6454 I III 7/3/1986 INTERNATIONAL MEDICATION SYSTEMS RUBBER CLOSURES AND VIAL INJECTORS
LTD
6455 I III 7/1/1986 CUNO INC ZETAPOR O.45 WP MEMBRANE CARTRIDGES
6456 I II 6/18/1986 EPROVA AG FENOFIBRATE (PROCETOFEN)
6457 A III 6/30/1986 B BRAUN MEDICAL INC EXCEL® PLASTIC CONTAINER STERILIZATION
PROGRAM
6458 A III 6/30/1986 B BRAUN MEDICAL INC MATERIAL QUALIFICATION FOR THE EXCEL
PLASTIC CONTAINER
6459 A III 6/30/1986 B BRAUN MEDICAL INC VAPOR TRANSMISSION STUDIES FOR THE
EXCEL PLASTIC CONTAINER
6460 A III 6/30/1986 B BRAUN MEDICAL INC CHEMISTRY MANUFACTURING AND CONTROLS
FOR THE EXCEL PLASTIC CONTAINER
6461 A III 6/30/1986 B BRAUN MEDICAL INC INK QUALIFICATION STUDIES FOR THE EXCEL®
PLASTIC CONTAINERS
6462 A III 6/30/1986 B BRAUN MEDICAL INC ACCELERATED STUDIES FOR THE EXCEL
PLASTIC CONTAINER
6463 I III 1/7/1986 SOLVAY AND CIE SA ELTEX B 4921
6464 I II 6/20/1986 BRISTOL LABORATORIES INC DIV METHODS, FACILITIES, AND CONTROLS IN
BRISTOL MYERS CO MAYAGUEZ, PUERTO RICO
6465 I III 1/7/1984 SOLVAY AND CIE SA HD-PE COPOLYMER ELTEX A 4009
6466 I II 6/25/1986 ORION CORP LTD MINOXIDIL
6467 I II 7/11/1986 MIKART INC LORTAB TABLETS
6468 I II 6/17/1986 HEXAGON LABORATORIES INC METHOCARBAMOL
6469 I II 6/15/1986 HEXAGON LABORATORIES INC PROPANTHELINE BROMIDE
Page 202
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6470 I II 6/30/1986 PHARMACIA AND UPJOHN FACILITIES AND CONTROLS IN WEST SUSSEX,
U.K.
6471 I II 7/9/1986 CUNO INC ZETAPOR 0.20UM ST MEMBRANE CARTRIDGES,
MERIDEN, CT
6472 I II 1/23/1985 HEXAGON LABORATORIES INC THIORIDAZINE HYDROCHLORIDE
6473 I III 6/25/1986 INTRAPAC CORP PLASTIC BOTTLES AND CLOSURES
6474 I II 7/11/1986 NOVOPHARM LTD FACILITIES, PERSONNEL,OPERATING PROC. AT
ONTARIO, CANADA
6475 I II 7/9/1986 HOECHST CELANESE CORP ACETOHEXAMIDE USP
6476 I III 7/14/1986 WEST AMERICAN RUBBER CO WEST AMERICAN RUBBER COMPOUND 55-P-146
Page 203
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6501 A V 6/18/1986 STERIS CONTRACT STERILIZATION FACILITY AT1880
INDUSTRIAL DRIVE LIBERTYVILLE, IL.
6502 I II 7/18/1986 HEINRICH MACK NACHF 5-FLUORO-2'-DEOXYURIDINE
6503 I II 7/21/1986 HILL DERMACEUTICALS INC DERMA-SMOOTHE CAPSULES
6504 A II 7/29/1986 BACHEM AMERICAS INC SALMON CALCITONIN (SCT)
6505 A II 7/23/1986 DIPHARMA FRANCIS SRL NIFEDIPINE USP
6506 I II 7/11/1986 ROHM AND HAAS CO CHOLESTYRAMINE RESIN, USP-AMBERLITE IRP-
276
6507 I II 7/22/1986 ASPEN OSS BV ARGININE VASOPRESSIN
6508 I V 7/17/1986 LABORATORY ANALYTICAL BIOLOGY INC VALIDATION REPORT ON FLURAZEPAM AND IT'S
MAJOR METABOLITES
6509 I II 7/23/1986 CAROLINA MEDICAL PRODUCTS CO FACILITIES, PERSONNEL AND GENERAL OPER.
PROC. IN N. CAROLINA
6510 I V 7/17/1986 LABORATORY ANALYTICAL BIOLOGY INC DETERMINATION OF HALOPERIDOL IN HUMAN
PLASMA USING GC-MS
6511 I II 7/30/1986 SCHERING CHEMICALS LTD ULTRALANUM CREAM PLAIN
6512 I IV 7/31/1986 GATTEFOSSE ESTABLISSEMENTS PRECIFAC
6513 I II 7/30/1986 FISONS PHARMACEUTICAL LTD NEDOCROMIL SODIUM
6514 I II 7/31/1986 RAYLO CHEMICALS FACILITIES, PERSONNEL AND OPERATING
PROCED. IN ALBERTA, CANADA
6515 I V 7/9/1986 LABORATORY ANALYTICAL BIOLOGY INC VALIDATION REPORT ON NITROGLYCERIN
METABOLITES
6516 I V 7/17/1986 LABORATORY ANALYTICAL BIOLOGY INC VALIDATION REPORT ON PRAZEPAM AND IT'S
MAJOR METABOLITES
6517 I I 8/1/1986 HELSINN CHEMICALS SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SWITZERLAND.
6518 I II 4/11/1986 HELSINN CHEMICALS SA CHLORZOXAZONE DRUG SUBSTANCE
6519 I II 8/1/1986 SELOC FRANCE SODIUM VALPROATE
6520 I III 8/6/1985 MILLIKEN AND CO MILLAD 3905 (DIBENZYLIDENE SORBITOL)
6521 I III 6/19/1986 CUNO INC ZETAPOR 0.45 UM SP MEMBRANE CARTRIDGES
6522 A II 8/7/1986 CAMBREX PROFARMACO MILANO SRL ALBUTEROL /SALBUTAMOL SULPHATE
6523 I II 8/6/1986 PCAS TRIMIPRAMINE MALEATE
6524 I II 8/7/1986 CAMBREX PROFARMACO MILANO SRL ALBUTEROL BASE
6525 A II 8/11/1986 PHARMACIA AND UPJOHN CO LLC DEXAMETHASONE SODIUM PHOSPHATE USP
WHOLLY OWNED SUB OF PFIZER INC
6526 I II 8/12/1986 ORGANICHEM CORP AMINOBISAMIDE HYDROCHLORIDE
6527 I II 7/24/1986 BOEHRINGER INGELHEIM PHARMA KG PHYSOSTIGMINE SALICYLATE
6528 I III 8/8/1986 TECHNICAL COATINGS CO SUB BACKGROUND, PERSONNEL AND PROCEDURES
BENJAMIN MOORE AND CO FOR DEVELOPMENT OF NEW ANTI-CANCER
AGENTS IN UNITED KINGDOM
6529 I II 8/8/1986 LABORATOIRE CHOAY AMIODARONE HYDROCHLORIDE INJECTION
6530 I II 7/25/1986 BOEHRINGER INGELHEIM CHEMICALS METAXALONE
INC
6531 I II 6/9/1986 ANTIBIOTICOS SPA IBUPROFEN
Page 204
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6532 I II 8/11/1986 RICHARDSON VICKS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN NORTH CAROLINA.
6533 I II 8/12/1986 NIPPON KAYAKU CO LTD DEOXYSPERGUALIN HYDROCHLORIDE FOR
INJECTION
6534 I II 7/31/1986 NORDION CANADA INC SODIUM MOLYBDATE MO99
6535 I II 8/15/1986 IROPHARM LTD IMIPRAMINE HYDROCHLORIDE
6536 I II 8/9/1986 RHONE-POULENC SANTE INC GADOLINIUM OXIDE 99.99 (PHOSPHOR GRADE)
6537 I II 8/12/1986 NIPPON KAYAKU CO LTD DEOXYSPERGUALIN HYDROCHLORIDE
6538 A IV 8/14/1986 ASHLAND LLC HYDROXYPROPYL CELLULOSE
6539 I II 8/6/1986 BERK PHARMACEUTICALS LTD A & PLACEBO FUROSEMIDE (FRUSEMIDE TABS)
40MG
6540 I III 8/7/1986 PCI SERVICES INC PACKAGING PROCEDURES AT ESSEX, UK
6541 I III 8/15/1986 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMULATION B5001-45
GRAY
6542 I IV 7/9/1986 LUBRIZOL ADVANCED MATERIALS INC NOVEON CA-1/NOVEON CA-2 (CALCIUM
POLYCARBOPHIL USP)
6543 I II 8/15/1986 PFIZER CHEMICALS DIV PFIZER INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN RINGASKIDDY, IRELAND.
6544 I II 8/19/1986 PFIZER SA TINIDAZOLE
6545 I II 8/15/1986 JM HUBER POLYMER SERVICES GROUP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ORANGE, TEXAS.
6546 I II 8/19/1986 WHITBY RESEARCH INC SUB ETHYL N-0437 SYNTHESIS AND NON-CLINICAL STUDIES
CORP AT IRVINE, CALIF.
6547 I II 8/25/1986 DUPHAR BV CALCITRIOL
6548 I III 7/30/1986 SOCIETE BOURGUIGNONNE D BENVIC PEB 02 P/0546
APPLICATIONS PLASTIQUES
6549 I III 7/30/1986 SOCIETE BOURGUIGNONNE D BENVIC PEB 02 P/0102
APPLICATIONS PLASTIQUES
6550 I III 7/30/1986 SOCIETE BOURGUIGNONNE D BENVIC PEB 01 P/0546 (A PVC CMPD)
APPLICATIONS PLASTIQUES
6551 I III 7/30/1986 SOCIETE BOURGUIGNONNE D BENVIC PEB 01 P/0102
APPLICATIONS PLASTIQUES
6552 I I 8/18/1986 EXTAL PTY LTD DIV JOHNSON AND MANUFACTURING SITE, FACILITIES,
JOHNSON PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN TASMANIA, AUSTRALIA.
6553 I II 8/13/1986 QUATRUM TRIAMCINOLONE BASE
6554 A V 8/18/1986 SYNERGY HEALTH STERILISATION UK COBALT 60 GAMMA IRRADIATION CONTRACT
LTD STERILIZATION FACILITY LOCATED IN READING,
BERKSHIRE, ENGLAND
6555 A V 8/18/1986 SYNERGY HEALTH STERILISATION UK COBALT 60 GAMMA IRRADIATION CONTRACT
LTD STERILIZATION FACILITY LOCATED IN
BRADFORD, WEST YORKSHIRE, ENGLAND
Page 205
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6556 I II 7/14/1986 PROCTER AND GAMBLE FACILITIES, PERSONNEL AND OPER. PROC. AT
PHARMACEUTICALS GERMANY GMBH WEITERSTADT, GERMANY
6557 I III 8/25/1986 STATOIL POLYETHYLENE RESIN L500
6558 I II 9/1/1986 ORGANICHEM CORP SR-2508, HYPOXIC CELL RADIOSENSITIZER
6559 I II 8/29/1986 ETHYL CORP TOLRESTAT
6560 I II 8/29/1986 DIOSYNTH BV 6-ALPHA-METHYLPREDNISOLONE SODIUM
SUCCINATE
6561 I II 8/7/1986 TSUJIMOTO KAGAKU KOGYO CO LTD DEXTROMETHORPHAN PHENOLPHTHALINATE
6562 I II 8/22/1986 UNIV TEXAS MD ANDERSON CANCER CYCLOTRON-PRODUCED
CENTER RADIOPHARMACEUTICALS
6563 I II 8/30/1986 TOKUYAMA CORP CHLORZOXAZONE USP
6564 I II 9/5/1986 ZENITH LABORATORIES INC FACIL. AND OPER. PROC. AT PRALEX CORP. IN
ST. CROIX,VIRGIN ISL
6565 I III 9/3/1986 3M PHARMACEUTICALS SCOTCHPAK BRAND HEAT SEALABLE
POLYESTER FILM NO. 6
6566 I II 8/28/1986 ASTA PHARMA AG PRODUCTION PLANT AT KUNSEBECK, GERMANY
6621 I IV 10/2/1986 VEB GELATINE UND LEIMWERKE EMPTY HARD GELATIN CAPSULES
6622 I II 10/8/1986 LABORATOIRES DETUDES ET DE ZOLPIDEM TARTRATE
RECHERCHES SYNTHELABO
6623 I III 9/30/1986 ALLPACK LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES
6624 I III 6/3/1986 ADRIAPLAST SPA ALKORPACK-P PLASTIC SHEET PACKAGING
6625 I III 6/3/1986 ADRIAPLAST SPA VENIPAK-P PLASTIC SHEET PACKAGING
6626 A II 10/15/1986 MSD INTERNATIONAL GMBH LORATADINE
6627 I III 9/22/1986 IDEMITSU PETROCHEMICAL CO LTD IDEMITSU POLYPROPYLENE FILM
6628 I III 10/15/1986 WYETH-AYERST LABORATORIES PROTOCOLS FOR EQUIVALENCY OF
PACKAGING COMPONENTS
6629 I II 10/14/1986 DR REDDYS LABORATORIES LTD L-METHYL DOPA
6630 A III 10/15/1986 A SCHULMAN INC PACKAGING MATERIAL
6631 I II 10/13/1986 CUNO INC ZETAPOR 0.20 UM AND 0.45 SP FLAT STOCK
MEMBRANE
6632 I III 9/30/1986 WILLIAM WARNE LTD RUBBER SEALING GASKET PART #300H 42P
6633 I II 10/14/1986 TOKUYAMA CORP FACILITIES PRODUCING PROPANTHELINE
BROMIDE
6634 I II 7/18/1986 FERRING AB MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MALMO, SWEDEN.
6635 I II 10/21/1986 AMERICAN CUSTOM DRYING CO INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BURLINGTON, NEW JERSEY.
6636 I II 10/22/1986 RELIABLE CHEMICAL CO PROTAMINE SULFATE (BULK)
6637 I III 10/20/1986 ADVANCED ELASTOMER SYSTEMS VYRAM THERMOPLASTIC RUBBER, GRADE 1055
6638 I II 10/21/1986 MIKART INC LORCET PLUS TABLETS
6639 I II 10/2/1986 GEDEON RICHTER LTD NORETHINDRONE 1 MG. AND MESTRANOL 0.05
MG. TABLETS IN BULK
6640 I IV 10/2/1986 GEDEON RICHTER LTD FINISHED DOSAGE FORM OF PLACEBO
TABLETS
6641 A II 10/20/1986 FIS FABBRICA ITALIANA SINTETICI SPA CARBAMAZEPINE
6642 I II 10/6/1986 LASA LABORATORIOS SA METHOCARBAMOL
6643 I II 10/21/1986 IRISH FINE CHEMICALS LTD DESIPRAMINE HYDROCHLORIDE
6644 A II 9/10/1986 OLON SPA TIMOLOL MALEATE
6645 I II 10/17/1986 ORCHIMIE SA (PRODUITS CHIMIQUES ET PERPHENAZINE
BIOCHIMIQUES)
6646 I II 10/27/1986 QUATRUM HYDROCORTISONE HEMISUCCINATE
6647 I I 10/22/1986 SPRAY TEK INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN NEW JERSEY.
6648 I II 10/17/1986 HOKURIKU SEIYAKU CO LTD TULOBUTEROL BASE
Page 208
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6649 I II 10/27/1986 LENNON LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PORT ELIZABETH, SOUTH
AFRICA.
6650 I II 10/29/1986 ROQUETTE FRERES MANNITOL GRANULAR G.G.
6651 I III 10/21/1986 SAFET EMBAMET LETHIAS SAFET MONOBLOC ALUMINUM CAN
6652 A II 8/8/1986 FERMION OY TOREMIFENE CITRATE
6653 I II 10/30/1986 MY K LABORATORIES INC FACILITIES, PERSONNEL AND GENERAL
OPERATING PROCEDURES IN ILL.
6654 I II 10/31/1986 NIACET CORP SODIUM ACETATE ANHYDROUS, USP GRADE
6655 I II 10/28/1986 EMERY CHEMICALS EMTHOX 6946 (NONOXYNOL-9)
6656 I II 9/30/1986 FINE CHEMICALS CORP PTY LTD THIOTHIXENE HYDROCHLORIDE
6657 I II 10/29/1986 NEO MICRO AG MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
6658 A II 10/29/1986 EUTICALS SPA SULFAPYRIDINE
6659 I II 10/28/1986 ZENECA INC COSMOCIL CQ (POLYHEXAMETHYLENE
BIGUANIDE HYDROCHLORIDE)
6660 I II 10/2/1986 GEDEON RICHTER LTD NORETHINDRONE 1 MG. AND ETHINYL
ESTRADIOL 0.035 MG. USP TABS.
6661 I II 11/6/1986 INDUSTRIE CHIMICHE FARMACEUTICHE PINDOLOL
ITALIANE SPA
6662 A II 11/1/1986 HERAEUS DEUTSCHLAND GMBH AND CISPLATIN USP
CO KG
6663 I II 11/5/1986 ACF CHEMIEFARMA NV DESIPRAMINE HYDROCHLORIDE
6664 I V 11/7/1986 INTERNATIONAL MEDICINES EXCHANGE EMORFAZONE, CLINICAL AND PRE-CLINICAL
DEVELOPMENT STUDIES
6665 I II 11/10/1986 EGIS PHARMACEUTICALS PRIVATE LTD DIETHYLCARBAMAZINE CITRATE USP
6666 I II 11/10/1986 CUNO INC ZETA PLUS 90 LP MEDIA CARTRIDGES AND FLAT
STOCK
6667 I II 11/5/1986 NV ORGANON HUMAN MENOPAUSAL GONADOTROPHIN 100
6668 I II 11/7/1986 ORCHIMIE SA (PRODUITS CHIMIQUES ET CYTARABINE
BIOCHIMIQUES)
6669 I II 11/10/1986 DR REDDYS LABORATORIES LTD IBUPROFEN
6670 I II 11/12/1986 CUNO INC ZETA PLUS 60 LP MEDIA CARTRIDGES AND FLAT
STOCK
6671 I III 11/5/1986 DUMA PACKAGING AS DUMA TAMPER-EVIDENT CONTAINERS AND
DUMACAPS
6672 A V 8/27/1986 STERIGENICS US LLC STERILE FINISHED PRODUCTS AND STERILE
PROCESSING OPERATIONS
6673 I II 11/12/1986 SOCIETA ITALIANA CORTICOSTEROIDI MEGESTROL ACETATE
SPA
6674 I II 11/11/1986 SOL PHARMACEUTICALS LTD SULFAMETHOXAZOLE AND TRIMETHOPRIM
6675 I II 11/20/1986 SHIONOGI AND CO LTD MOXALACTAM DIACID
Page 209
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6676 A III 10/17/1986 EXXONMOBIL CHEMICAL CO ESCORENE POLYPROPYLENE RESINS (1000
SERIES)
6677 A III 10/22/1986 EXXONMOBIL CHEMICAL CO ESCORENE POLYPROPYLENE RESINS (9000
SERIES)
6678 I II 11/7/1986 PHARMACIA AND UPJOHN SPA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MILAN, ITALY.
6679 I II 11/12/1986 SYNTEX USA INC METHYLTESTOSTERONE
6680 I II 11/20/1986 PENICK CORP MORPHINE SULFATE
6681 I II 11/21/1986 SOLVAY PHARMACEUTICALS FACILITIES, PERSONNEL AND GENERAL
OPERATING PROCEDURES IN GA
6682 I II 11/18/1986 PFC ITALIANA SRL DIV ALFA CHEMICALS HALOPERIDOL DECANOATE
ITALIANA
6683 I II 11/21/1986 HAARMANN AND REIMER GMBH DIBENZOSUBERONE
6684 A III 11/17/1986 AMCOR FLEXIBLES SHELBYVILLE FLEXIBLE PACKAGING MATERIALS
6685 I I 11/18/1986 GANES CHEMICALS INC PENNSVILLE 4-N,N-BIS(2-HYDROXYETHYL)-
DIV AMINOACETOPHENONE
6686 A II 11/14/1986 LUSOCHIMICA SPA DILTIAZEM HYDROCHLORIDE
6687 A II 11/18/1986 HOVIONE FARMACIENCIA SA BETAMETHASONE SODIUM PHOSPHATE
6688 I I 11/20/1986 TEVA PHARM & CHEMICAL WORKS FACILITIES, PERSONNEL AND OPERATING
PROCEDURES IN JERUSALEM
6689 A II 11/20/1986 DIPHARMA FRANCIS SRL DICLOFENAC SODIUM EP/USP
6690 I II 11/20/1986 KV PHARMACEUTICAL CO DISOPYRAMIDE S.R. CAPSULES (100 MG)
6691 I II 11/18/1986 EMERY CHEMICALS EMEREST 2703 (PEG-4 LAURATE)
6692 I II 11/25/1986 RIVOPHARM SA FACILITIES, PERSONNEL, AND GENERAL
OPERATING PROCEDURES.
6693 A II 11/25/1986 OLON SPA MINOXIDIL
6694 I III 11/26/1986 CUNO INC ZETA PLUS 90 SP MEDIA CARTRIDGES AND FLAT
STOCK
6695 I IV 11/26/1986 LONZA RIVERSIDE FILM COATING SOLUTION
6696 I II 11/28/1986 TOKUYAMA CORP SULFAMETHIZOLE
6697 I II 11/19/1986 BASF WYANDOTTE CORP HDO 1,6-HEXANEDIOL
6698 I II 11/25/1986 PENINSULA LABS INC BRADYKININ (A PEPTIDE)
6699 I II 12/2/1986 DIOSYNTH BV ORGOTEIN
6700 I II 11/6/1986 STERLING CHEMS INC LACTIC ACID 88% USP AND LACTIC ACID 88%
LOW AMMONIA
6701 I IV 12/17/1986 SHANDONG ENTERPRISES LTD EMPTY HARD GELATIN CAPSULES
6702 I II 11/24/1986 LEDERLE LABORATORIES DIV FACILITIES, PERSONNEL AND GENERAL OPER.
AMERICAN CYANAMID CO PROCEDURES IN GERMANY
6703 I V 12/3/1986 EASTMAN CHEMICAL CO 5-AMINOSALICYLIC ACID TOXICOLOGY AND
CLINICAL INFORMATION
6704 I II 12/3/1986 EASTMAN CHEMICAL CO 5-AMINOSALICYLIC ACID DOSAGE FORM FOR
CLINICAL RESEARCH
6705 I II 12/5/1986 CIPLA LTD METHOCARBAMOL
Page 210
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6706 I II 12/4/1986 WAITAKI INTERNATIONAL BIOSCIENCES LINOLEIC ACID
SUB WAITAKI CANADA LTD
6707 I II 12/3/1986 SALK INST BIOLOGICAL STUDIES [N-MeTyr1,Nle27,Asn28]-hGRF(1-29)-NHEt
6708 I II 11/26/1986 SIBEFAT SPA VERAPAMIL HYDROCHLORIDE
6709 I II 12/5/1986 PACKAGING COORDINATORS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN RICHMOND, VIRGINIA.
6710 I V 12/3/1986 TEVA PHARMACEUTICAL INDUSTRIES STERILE PROCESSING FACILITY FOR
LTD CEPHALOSPORIN IN JERUSALEM, ISRAEL
6711 A II 12/2/1986 MEDICHEM SA CHLORHEXIDINE BASE
6712 I II 12/5/1986 CAMBREX PROFARMACO MILANO SRL NAPROXEN SODIUM
6713 A II 11/28/1986 HOVIONE FARMACIENCIA SA BETAMETHASONE 21-ACETATE
6714 I II 12/3/1986 LERS CHEM DEVELOPMENT CICLOPROLOL HYDROCHLORIDE
6715 I II 12/5/1986 ORCHIMIE SA (PRODUITS CHIMIQUES ET FLUPHENAZINE HYDROCHLORIDE
BIOCHIMIQUES)
6716 I II 12/11/1986 CHUGAI PHARMACEUTICAL CO LTD SG-75 (NICORANDIL) BULK DRUG PRODUCT
6717 I I 12/5/1986 ROCHE AG FACILITIES, PERSONNEL AND GENERAL
OPERATING PROCEDURES
6718 I I 11/26/1986 MARIETTA CORP FACILITIES, PERSONNEL AND GENERAL
OPERATING PROCEDURES
6719 I II 12/8/1986 DAIICHI PURE CHEMICALS CO LTD METHIONINE-ENKEPHALIN
6720 I II 12/5/1986 BORREGAARD INDUSTRIES LTD 5-AMINO-N,N'-BIS(2,3-DIHYDROXYPROPYL)-
ISOPHTALAMIDE-HYDROCHLORIDE
6721 A II 12/1/1986 EXCELLA GMBH AND CO KG TRAZODONE HYDROCHLORIDE
6722 I I 12/15/1986 ROYCE LABORATORIES FACILITIES, PERSONNEL AND CONTROLS IN
FLORIDA
6723 I II 12/8/1986 ATOMIC ENERGY CORP FACILITIES AND GENERAL OPERATING
PROCEDURES AT KANATA, CANADA
6724 I II 11/25/1986 UNION CARBIDE AND CARBON CORP CARBON DIOXIDE, XENON AND OXYGEN
MIXTURE
6725 I II 12/15/1986 COMPANIA ESPANOLA DE SINTESIS 6-ALPHA METHYLPREDNISOLONE
QUIMICA SA
6726 I II 11/26/1986 COMPANIA ESPANOLA DE SINTESIS BETAMETHASONE DIPROPIONATE
QUIMICA SA
6727 I II 11/26/1986 COMPANIA ESPANOLA DE SINTESIS BETAMETHASONE SODIUM PHOSPHATE
QUIMICA SA
6728 I I 11/26/1986 COMPANIA ESPANOLA DE SINTESIS FACILITIES, PERSONNEL AND GENERAL
QUIMICA SA OPERATING PROCEDURES
6729 I II 12/17/1986 CUTTER BIOLOGICAL DIV MILES CLOTRIMAZOLE
LABORATORIES INC
6730 I II 12/15/1986 BALENCO ENTERPRISES INC MAPROTILINE HYDROCHLORIDE USP
6731 I II 12/15/1986 CUNO INC G OF ZETA PLUS 50 LP MEDIA CARTRIDGES AND
FLAT STOCK
6732 I II 12/15/1986 CUNO INC G. OF ZETA PLUS 30 LP MEDIA CARTRIDGES
AND FLAT STOCK.
Page 211
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6733 I III 12/15/1986 CUNO INC G OF ZETA PLUS 60 SP MEDIA CARTRIDGES AND
FLAT STOCK.
6734 I II 12/1/1986 SOCIETA ITALIANA MEDICINALI MANUFACTURING SITE, FACILITIES,
SCANDICCI PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
6735 A II 12/15/1986 OLON SPA TAMOXIFEN CITRATE
6736 I II 12/15/1986 MAY AND BAKER LTD KETOPROFEN
6737 I II 12/16/1986 GEDEON RICHTER LTD BROMOCRIPTINE MESYLATE USP
6738 A II 12/22/1986 GE HEALTHCARE INC SODIUM IODIDE I 123 PRODUCED VIA XENON XE
123
6739 I III 11/19/1986 BETHAM CORP 1510C FOAM PAD
6740 I II 12/26/1986 OKAMI CHEMICAL INDUSTRY CO LTD TIOPRONIN
6741 I II 12/22/1986 DSM ANDENO GMBH CARBASALATE CALCIUM
6742 I II 12/23/1986 RECORDATI INDUSTRIA CHIMICA E CARBAMAZEPINE
FARMACEUTICA SPA
6743 I II 12/19/1986 PRIME EUROPEAN THERAPEUTICALS FACILITIES, PERSONNEL, AND GENERAL
SPA (EUTICALS SPA) OPERATING PROCEDURES.
6744 I II 12/22/1986 SANDOZ LTD PHARMACEUTICAL DIV L-LEUCINE-ISOPROPYLAMINOCYCLOL
CHEMICAL DEVELOPMENT HYDROCHLORIDE
6745 A IV 12/22/1986 BASF SE KOLLIDON VA 64
6746 I II 12/29/1986 ANAQUEST DIV BOC INC FACILITIES, PERSONNEL AND GENERAL
OPERATING PROCEDURES IN OHIO
6747 I II 12/29/1986 ANAQUEST DIV BOC INC ENDROPHONIUM CHLORIDE USP
6748 I II 12/22/1986 HEXAGON LABORATORIES INC CARBAMAZEPINE USP
6749 I III 12/29/1986 DARTO MANUFACTURING INC DARTCO XYDAR RESINS
6750 I II 12/24/1986 BASF AKTIENGESELLSCHAFT RADIO-PHARMACEUTICAL SYNTHESIS MODULE
<< SYNTHERArV1 >>
6751 I II 12/24/1986 BASF AKTIENGESELLSCHAFT STERILE AREA 1 DEPARTMENT AT MONZA
FACILITY IN MILAN, ITALY.
6752 I III 12/30/1986 SETCO INC HIGH DENSITY POLYETHYLENE BOTTLES
6753 I II 11/26/1986 COMPANIA ESPANOLA DE SINTESIS HYDROCORTISONE HEMISUCCINATE
QUIMICA SA
6754 I III 12/30/1986 CUNO INC ZETA PLUS 50 SP MEDIA CARTRIDGES AND FLAT
STOCK
6755 I III 12/30/1986 CUNO INC ZETA PLUS 10 SP MEDIA CARTRIDGES AND FLAT
STOCK
6756 I III 12/15/1986 ALCAN CANADA FOILS PUSH-THRU FOIL
6757 I II 12/31/1986 ALDRICH CHEMICAL CO INC AMINOGUANIDINE HYDROCHLORIDE (W176-2)
6758 I III 12/30/1986 CUNO INC ZETA PLUS 30 SP MEDIA CARTRIDGES AND FLAT
STOCK
6759 I II 12/19/1986 PHARMECO LABORATORIES INC CYCLOPENTOLATE HYDROCHLORIDE (P-637)
6760 I II 12/29/1986 AYERST LABORATORIES INC DIV INTRANASAL INSULIN
AMERICAN HOME PRODUCTS CORP
6761 A II 1/5/1987 CAMBREX PROFARMACO MILANO SRL DILTIAZEM HCL
Page 212
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6762 I IV 1/2/1987 GUANGZHOU PHARMACEUTICAL EMPTY HARD GELATIN CAPSULES
PACKAGING MATERIAL FACTORY
6763 I II 12/23/1986 SELOC AG IMIPRAMINE PAMOATE
6764 I II 1/5/1987 ACF CHEMIEFARMA NV IMIPRAMINE HYDROCHLORIDE
6765 I III 1/6/1987 CONPLEX INC THERMOPLASTIC SHEET
6766 I II 1/7/1987 GE SILICONES BAYSILONE FLUID M 1000 S
6767 A II 12/29/1986 MEDICHEM SA LOXAPINE SUCCINATE
6768 I II 1/9/1987 PENICK CORP OXYCODONE HYDROCHLORIDE
6769 I II 1/7/1987 GE SILICONES BAYSILONE ANTIFOAM 100%
DIMETHYLPOLYSILOXANE
6770 I II 10/6/1986 SUZHOU BIOCHEMICAL SODIUM HEPARIN.
PHARMACEUTICAL MANUFACTURING
CO
6771 A II 1/15/1987 BAYER AG CLOTRIMAZOLE
6772 I II 1/13/1987 SELOC FRANCE NIFEDIPINE
6773 I II 1/15/1987 PENCO OF LYNDHURST INC METHOCARBAMOL
6774 I I 1/15/1987 CHELSEA LABORATORIES INC FACILITIES, PERSONNEL, & GENL OPERATING
PROCEDURES IN NC.
6775 I II 12/10/1986 ERCI FACILITIES SERVICES CORP SOP'S FOR DRUG STORAGE AND DISTRIBUTION
OF NCI DRUGS.
6776 I II 1/12/1987 INDUSTRIE CHIMICHE FARMACEUTICHE THIOTHIXENE BASE AND HC1
ITALIANE SPA
6777 I II 1/9/1987 DINAMITE DIPHARMA SPA ISOSORBIDE-2-MONONITRATE (2-ISMN)
6778 A II 1/9/1987 DIPHARMA FRANCIS SRL ISOSORBIDE-5-MONONITRATE (5-ISMN)
6779 A III 1/21/1987 ALPHA PACKAGING HDPE & LDPE BOTTLES
6780 I II 1/15/1987 PHARM ECO LABORATORIES INC N,N'-BIS (2-CHLOROETHYL)-N-NITROSOUREA
(CARMUSTINE)
6781 I III 1/16/1987 MOBAY CHEMICAL CORP MERLON M 40(H)F-3291
6782 I III 1/19/1987 CUNO INC ZETA PLUS 01A MEDIA CARTRIDGES AND FLAT
STOCK
6783 I II 12/19/1986 ORION CORP LTD TOLMETIN SODIUM
6784 I II 1/19/1987 HOECHST AG CEFAZOLIN SODIUM INJECTION (STERILE
FILLING)
6785 I III 1/19/1987 CUNO INC ZETA PLUS 30 CP MEDIA CARTRIDGES & FLAT
STOCK
6786 I II 1/8/1987 QUATRUM HYDROCORTISONE ACETATE
6787 I IV 1/23/1987 SHIONOGI AND CO LTD CAPSULES 7432-S
6788 I II 1/27/1987 PFIZER INC TRIAMCINOLONE 21-ACETATE
6789 I II 1/23/1987 DOTTIKON EXCLUSIVE SYNTHESIS AG DILUTED ISOSORBIDE MONONITRATE
6790 I III 1/19/1987 CUNO INC ZETA PLUS 70 CP MEDIA CARTRIDGES & FLAT
STOCK
6791 I III 1/19/1987 CUNO INC ZETA PLUS 60 CP MEDIA CARTRIDGES & FLAT
STOCK
6792 I IV 1/14/1987 PHARMACIA AND UPJOHN AB SEPHADEX GEL FILTRATION MEDIA
Page 213
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6793 A II 1/20/1987 SOUTHWEST SYNTHETIC SULFAMETHOXAZOLE USP
PHARMACEUTICAL CORP LTD
6794 I IV 1/19/1987 PHARMACIA AND UPJOHN AB SEPHACRYL GEL FILTRATION MEDIA
6795 A II 1/20/1987 SOUTHWEST SYNTHETIC TRIMETHOPRIM USP
PHARMACEUTICAL CORP LTD
6796 I II 1/22/1987 PURDUE UNIV ASEPTIC FORMULATION, FILL, AND FINISH
FACILITY IN SAN DIEGO, CA.
6797 I II 1/26/1987 ORION CORP LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MANKKAA PLANT.
6798 I II 1/28/1987 ANAQUEST INC METHOXYFLURANE
6799 I II 1/30/1987 WISCONSIN ANALYTICAL AND ISOSORBIDE DINITRITE (ISDN), 2-ISMN AND 5-
RESEARCH SERVICES LTD ISMN
6800 I II 2/2/1987 IMHAUSEN CHEMIE GMBH HALOPERIDOL
6801 I II 1/27/1987 KV PHARMACEUTICAL CO BROMPHENIRAMINE
MALEATE/PHENYLPROPANOLAMINE C.R.
TABLET
6802 I II 1/30/1987 UCB BIOPRODUCTS SA FACILITIES, PERSONNEL AND GENERAL
OPERATING PROCEDURES
6803 I II 2/5/1987 GRAESSER LABORATORIES LTD ISOSORBIDE-2-MONONITRATE
6804 I II 2/2/1987 UPJOHN CO U-62,840
6805 I II 1/28/1987 RAYLO CHEMICALS 2',3'-DIDEOXYCYTIDINE
6806 I II 2/2/1987 SELOC AG IMIPRAMINE HYDROCHLORIDE
6807 I IV 1/27/1987 PHARMACIA AND UPJOHN AB SEPHADEX ION EXCHANGE MEDIA
6808 I II 2/4/1987 SANOFI CHIMIE FLURAZEPAM HYDROCHLORIDE
6809 I II 2/5/1987 KYOWA HAKKO KOGYO CO LTD ALPHA-MERCAPTOPROPIONYLGLYCINE
6810 I III 1/19/1987 CUNO INC ZETA PLUS 50 CP MEDIA CARTRIDGES AND FLAT
STOCK
6811 I II 1/23/1987 SOCIETA ITALIANA CORTICOSTEROIDI FLUNISOLIDE
SPA
6812 I II 1/19/1987 CHEMINOVA A S FYFANON TECHNICAL
6813 I III 1/19/1987 CUNO INC ZETA PLUS 05 SP MEDIA CARTRIDGES AND FLAT
STOCK
6814 A II 1/23/1987 TEVA PHARMACEUTICAL INDUSTRIES CLOBETASOL PROPIONATE
LTD
6815 I II 2/4/1987 SIBEFAT SPA SODIUM CROMOGLYCATE
6816 I III 1/19/1987 CUNO INC ZETA PLUS 10 CP MEDIA CARTRIDGES AND FLAT
STOCK
6817 A II 1/23/1987 TEVA PHARMACEUTICAL INDUSTRIES PANCURONIUM BROMIDE
LTD
6818 I II 2/11/1987 ALTANA LOMBERG CHEMISCHE FABRIK THEOPHYLLINE SUSTAINED RELEASE
CAPSULES (BY-158)
6819 I II 1/6/1987 KYOWA HAKKO KOGYO CO LTD DACARBAZINE
6820 I III 2/4/1987 WINN PACKAGING CO HIGH DENSITY POLYETHYLENE PLASTIC
CONTAINERS
Page 214
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6821 A II 12/16/1986 RELIANCE CELLULOSE PRODUCTS LTD MICROCRYSTALLINE CELLULOSE
6822 I II 2/12/1987 ASTA PHARMA AG PHARMACEUTICAL PRODUCTION PLANT IN
KUNSEBECK, GERMANY
6823 I II 2/6/1987 PENINSULA LABS INC D-ALA-8-THR-NH2
6824 I V 2/10/1987 SOUTH FLORIDA BIOAVAILABILITY EFFECTS OF BIPERIDEN ON THE
CLINIC INC PHARMACOKINETICS OF HALOPERIDOL
6825 I II 2/13/1987 DIOSYNTH BV BETAMETHASONE MICRO
6826 I II 2/10/1987 MEPHA AG FACILITIES, PERSONNEL AND GENERAL OPER.
PROC. IN SWITZERLAND
6827 A II 2/13/1987 LEK PHARMACEUTICALS DD BROMOCRIPTINE MESYLATE USP
6828 I IV 2/11/1987 EMERY CHEMICALS EMERWAX 1266 EMULSIFYING WAX
6829 I II 2/19/1987 ELAN PHARMA LTD NIFEDIPINE 50 MG. TABLETS
6830 I II 1/23/1987 QUATRUM METHYLPREDNISOLONE HEMISUCCINATE
6831 I III 2/23/1987 SPARTECH PLASTICS COMPOSITE THERMOPLASTIC SHEET
GTE/MTE/FTE
6832 I II 1/19/1987 QUATRUM METHYLPREDNISOLONE BASE
6833 I III 2/24/1987 TECHNICAL PLASTIC EXTRUDERS INC PHARMACEUTICAL GRADE POLYVINYL
CHLORIDE FILM AND SHEETING
6834 I II 2/13/1987 SUPERIOR INC FACILITIES, PERSONNEL AND PROCEDURES IN
FELTON, PA
6835 I II 2/23/1987 LABOCHIM SPA METAPROTERENOL SULFATE USP
6836 I II 2/26/1987 ORGANICHEM CORP AMINOBISAMIDE HYDROCHLORIDE
6837 I III 2/23/1987 ALUMINUM CO AMERICA PHAR 9423
6838 A II 2/27/1987 TEVA PHARMACEUTICAL INDUSTRIES METOPROLOL TARTRATE USP
LTD
6839 A III 3/6/1987 HOSPIRA INC ADD-VANTAGE FLEXIBLE DILUENT CONTAINER
6840 I II 2/18/1987 ORION CORP LTD PRAZOSIN HCL DELTA-FORM
6841 I II 2/18/1987 ORION CORP LTD PRAZOSIN HCL ALPHA-FORM
6842 I III 3/3/1987 JAMES RIVER CORPORATION MANU OF CELESTRA X 1.00 LLP-T090 AND V090
NONWOVEN FABRICS
6843 A II 3/3/1987 ALBEMARLE CORP FENOPROFEN CALCIUM, USP+BP
6844 I III 2/24/1987 WACHUSETT MOLDING CORP PACKAGING MATERIALS
6845 I II 2/26/1987 PHARM ECO LABORATORIES INC 2,6-DICHLORO-N-(4,5-DIHYDRO-IH-IMIDAZOL-2-
YL)-1,4-BEZENEDIAMINE MONO
6846 I II 3/3/1987 INDUSTRIE CHIMICHE FARMACEUTICHE FACILITIES, PERSONNEL AND OPERATING
ITALIANE SPA PROCEDURES IN VARESE,ITALY
6847 I II 3/6/1987 DYNAMIT NOBEL AG NITROGLYCERIN 5% IN MIGLYOL 829
6848 I II 3/9/1987 HOECHST MARION ROUSSEL SA TRIAMCINOLONE 21-ACETATE
6849 I II 2/26/1987 PHARM ECO LABORATORIES INC XYLAZINE HYDROCHLORIDE
6850 I II 3/11/1987 FINE CHEMICALS CORP FLUPHENAZINE ENANTHATE
6851 I I 2/27/1987 CYANAMID GREAT BRITAIN LTD FACILITY AT GOSPORT HANTS, ENGLAND
6852 I III 2/25/1987 SILGAN PLASTICS CORP PACKAGING MATERIALS
6853 A II 3/10/1987 UCB PHARMA SA CETIRIZINE HYDROCHLORIDE
Page 215
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6854 I II 3/3/1987 ORION CORP LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN FINLAND.
6855 A III 3/10/1987 BARNHARDT MANUFACTURING CO PHARMACEUTICAL COIL PRODUCTS
6856 I II 3/10/1987 GANES CHEMICALS INC PENNSVILLE DOXEPIN HYDROCHLORIDE
6857 I II 3/9/1987 CAMBREX PROFARMACO MILANO SRL MECLOFENAMATE SODIUM
6858 I II 3/10/1987 CUNO INC STERILE PROCESSING FACILITY IN WINNIPEG,
MANITOBA, CANADA.
6859 I II 3/13/1987 DIOSYNTH BV STABILIZED ESTRONE SODIUM SULPHATE
6860 I II 2/27/1987 PFC ITALIANA SRL DIV ALFA CHEMICALS NIFEDIPINE
ITALIANA
6861 I II 3/13/1987 DIOSYNTH BV EQUILIN SODIUM SULPHATE STABILIZED
6862 I II 3/2/1987 DAITO PHARMACEUTICALS CO LTD CLEMASTINE FUMERATE
6863 I II 3/10/1987 CUNO INC 100 TSM MEDIA CARTRIDGES
6864 I III 3/4/1987 HELVOET PHARMA ITALIA SPA RUBBER STOPPERS IN GREY CHLOROBUTYL
COMPOUND 464.04
6865 I III 3/4/1987 HELVOET PHARMA ITALIA SPA RUBBER STOPPERS IN GREY BROMOBUTYL
COMPOUND 544.04
6866 I III 3/6/1987 TOP SEAL CORP INJECTION MOLDED CLOSURES
6867 I III 3/4/1987 HELVOET PHARMA ITALIA SPA EPR COPOLYMER RUBBER COMPOUND 056.04
6868 A II 1/20/1987 FINORGA SAS ESMOLOL HYDROCHLORIDE
6869 I II 3/5/1987 ERREGIERRE SPA ECONAZOLE NITRATE
6870 A II 3/5/1987 ERREGIERRE SPA MICONAZOLE NITRATE
6871 I II 3/13/1987 QUIMICA SINTETICA SA MECLOFENAMATE SODIUM USP
6872 I II 3/13/1987 ZAMBON SPA NAPROXEN USP
6873 I II 3/16/1987 HILLESTAD CORP COUMARIN TABLETS 100 MG.
6874 I II 3/9/1987 SIBEFAT SPA GEIBROZIL USP
6875 A II 3/19/1987 KANEKA CORP N-[1(S)-ETHOXYCARBONYL-3-PHENYLPROPYL]-
L-ALANINE (ALE)
6876 I III 3/13/1987 LLOYD MANUFACTURING CO INC GUM RUBBER FORMULATION #3141-71
6877 A II 3/6/1987 SEKISUI MEDICAL CO LTD CLEMASTINE FUMERATE
6878 I II 3/20/1987 DAIICHI PURE CHEMICALS CO LTD MIX-RR
6879 I II 3/10/1987 SANKYO CHEMICAL INDUSTRIES INC FLAVOXATE HYDROCHLORIDE
6880 I II 3/20/1987 MOEHS SA DIV SANOF TRIMETHOPRIM
6881 I II 3/23/1987 NOVA PHARMACEUTICAL CORP NPC-567 PRECLINICAL STUDIES &
6882 I II 3/16/1987 PROSINTEX INDUSTRIE CHIMIQUE MICONAZOLE NITRATE
ITALIANE SRL
6883 I II 3/18/1987 SHIONOGI AND CO LTD COMPOUND 7432-S
6884 I II 3/23/1987 LEO PHARMACEUTICAL PRODUCTS LTD SODIUM TAURO-24,25-DIHYDROFUSIDATE BULK
SUBSTANCE
6885 A II 1/20/1987 CIPLA LTD ALBUTEROL SULFATE USP
6886 I II 1/21/1987 CIPLA LTD ALBUTEROL
6887 A II 3/16/1987 MEDICHEM SA AMOXAPINE
6888 I II 3/13/1987 QUATRUM METHYLPREDNISOLONE ACETATE
Page 216
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6889 I II 3/25/1987 ICI PHARMACEUTICALS PUERTO RICO MANUFACTURING SITE, FACILITIES,
INC PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CAROLINA, PUERTO RICO.
6890 I II 3/27/1987 AMERSHAM CORP IN-113M GENERATOR
6891 I IV 3/26/1987 DOW CORNING CORP TRIMETHYLSILOXY ENDBLOCKED
POLYMETHYLHYDROGEN SILOXANE
6892 I II 3/25/1987 LONZA AG L-CARNITINE (VIT. BT)
6893 I III 3/23/1987 NORWOOD INDUSTRIES INC NORWOOD KM-1392-00 AND IT'S COMPONENTS
6894 A V 3/16/1987 STERIGENICS US LLC STERILE FINISHED PRODUCTS AND STERILE
PROCESSING OPERATIONS LOCATED IN HAW
RIVER, NC.
6895 A II 3/26/1987 NOVARTIS PHARMA AG POLY (DL-LACTIDE-CO-GLYCOLIDE)
6896 I I 2/28/1987 HOVIONE MACAU SOCIEDADE QUIMICA MANUFACTURING SITE, FACILITIES,
LDA PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MACAU.
6897 I II 4/1/1987 AUTOMATIC LIQUID PACKAGING INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN WOODSTOCK, ILLINOIS.
6898 I II 3/25/1987 ISP SODIUM HYDROGEN VALPROATE
6899 I II 3/31/1987 ORION CORP FARMOS CHEMICAL PLANT METHOTREXATE 2,5 MG TABLET
6900 I II 3/25/1987 AMOCO CHEMS CORP AFFILIATE POLYARYLSULFONE RESIN RADEL A-400
AMERICAN OIL CO
6901 I II 3/30/1987 POYTHRESS AND CO FACIL, PERSONNEL & CONTROLS AT
RICHMOND, VA
6902 I III 4/2/1987 BCL LTD REGENERATED CELLULOSE FILM
6903 I III 4/2/1987 BCL LTD REGENERATED CELLULOSE FILM
6904 I II 4/3/1987 BLASCHIM SPA FENOPROFEN CALCIUM
6905 I II 3/30/1987 ASTRAZENECA PHARMACEUTICALS LP ATENOLOL
6906 I II 3/31/1987 QUIMICA SINTETICA SA FACIL, PERSONNEL AND GENL OPERATING
PROCEDURES AT MADRID,SPAIN
6907 I II 3/26/1987 INJECTRONICS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CLINTON, MA
6908 A II 4/7/1987 SIGMA ALDRICH IRELAND LTD DOXYLAMINE SUCCINATE USP
6909 I II 4/3/1987 ZEELAND CHEMICALS INC PARA-AMINOSALICYLIC ACID, SODIUM
6910 I II 3/26/1987 CIBA GEIGY LTD CHLORTHALIDONE USP
6911 I II 4/8/1987 ZENECA PHARMACEUTICALS ZESTRIL (LISINOPRIL) TABLETS
6912 I II 3/30/1987 CELLTECH LTD FACILITIES FOR PRODUCTION OF BULK
RECOMBINANT HUMAN GROWTH HORMONE
6913 A V 3/16/1987 STERIGENICS US LLC STERILE FINISHED PRODUCTS AND STERILE
PROCESSING OPERATIONS LOCATED IN SALEM,
NEW JERSEY
6914 A II 4/9/1987 FINE CHEMICALS CORP PTY LTD BENZTROPINE MESYLATE
Page 217
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6915 I II 3/16/1987 PROCESS TECHNOLOGY INC FACILITIES, PERSONNEL AND PROCEDURES IN
WEST MEMPHIS, ARIZONA
6916 I III 3/4/1987 BUNDER GLAS GMBH PACKAGING MATERIALS/BRONCHOLATOR AND
RHINOLATOR
6917 I II 4/10/1987 AL HIKMA PHARMACEUTICALS FACILITIES, PERSONNEL AND GENERAL
OPERATING PROCEDURES IN AMMAN JORDON
6918 I II 4/7/1987 MERCK SHARP AND DOHME RESEARCH L-651,392-00N,4-BROMO-2,7-DIMETHOXY-3H-
LABORATORIES DIV MERCK AND CO INC PHENOTHIAZIN-3-ONE
Page 218
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6943 I IV 4/21/1987 MILES INC EX-CYTE III (BOVINE ORIGIN) GROWTH
ENHANCEMENT MEDIA SUPPLEMENT
6944 I II 4/22/1987 E MERCK SODIUM DIETHYLDITHIOCARBAMATE
TRIHYDRATE-EXTRA PURE
6945 I I 4/24/1987 SMITH KLINE & FRENCH LABS DIV ANTI-INFECTIVE FACILITIES AT CONSHOHOKEN,
SMITHKLINE BECKMAN CORP PENNSYLVANIA
6946 I II 4/15/1987 DR REDDYS LABORATORIES LTD ESTRADIOL
6947 A II 4/7/1987 BK GIULINI GMBH PHOSKADENT NA 211
(SODIUMMONOFLUOROPHOSPHATE)
6948 I II 4/28/1987 STELLA KG MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ELTVILLE, GERMANY.
6949 I III 4/30/1987 GEORGIA PACKAGING INC PRODUCTION MODULE 2 (PM2) ASEPTIC
FACILITY LOCATED CO. DUBLIN, IRELAND
6950 I II 4/28/1987 STELLA KG MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN KASTELLAUN, GERMANY.
6951 I III 4/27/1987 HYGENIC CORP PROCESSING OF LATEX SHEETING FOR
COMPOUND FORMULA TR200
6952 I II 4/16/1987 LABORATOIRES FOURNIER SA FENOFIBRATE CAPSULES
6953 I I 4/16/1987 SYNKEM DIV PLASTO SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CHENOVE, FRANCE.
6954 I II 4/16/1987 LABORATOIRES FOURNIER SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN FONTAINE-LES-DIJON
FRANCE.
6955 A II 5/11/1987 EUTICALS SPA BROMOCRIPTINE MESYLATE
6956 I III 5/4/1987 BRISTOL-MYERS PRODS DIV BRISTOL- PACKAGING MATERIALS
MYERS CO
6957 I II 4/30/1987 SOUTH FLORIDA BIOAVAILABILITY DETERMINATION OF ERYTHROMYCIN IN HUMAN
CLINIC INC SERUM BY BIOLUMINOMETRY ASSAY
6958 I II 4/30/1987 SOCIETA ITALIANA CORTICOSTEROIDI TRIAMCINOLONE HEXACETONIDE
SPA
6959 I II 5/11/1987 POLI INDUSTRIA CHIMICA SPA FACILITIES PERSONNEL AND GENERAL
OPERATING PROCEDURES IN MILAN, ITALY
6960 I II 5/8/1987 FARMABOIS BETAMETHASONE 17 VALERATE
6961 I II 5/8/1987 FARMABOIS BETAMETHASONE
6962 I II 5/8/1987 HEXAGON LABORATORIES INC BENZPHETAMINE HYDROCHLORIDE
6963 A III 4/29/1987 SCANDIA PLASTICS INC HDPE PILL BOTTLES
6964 I II 4/28/1987 FOREST LABORATORIES INC FACILITIES AND PERSONNEL IN RIO PIEDRAS,
PUERTO RICO
6965 I II 5/8/1987 PARTICLE SIZE TECHNOLOGY INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PENNSYLVANIA.
Page 219
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6966 I II 5/8/1987 SIGMA F AND D DIV LTD APOMORPHINE HCl
6967 A II 5/8/1987 NORAMCO INC MORPHINE SULFATE
6968 I II 5/12/1987 MACFARLAN SMITH JOHNSON MATTHEY MANUFACTURING SITE, FACILTIES,
PLC BUSINESS PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN READING, ENGLAND
6969 I II 4/30/1987 DIAMALT AG ENCAINIDE HYDROCHLORIDE
6970 I II 4/14/1987 NOVO NORDISK AS NORDITROPIN (BIOSYNTHETIC HUMAN
GROWTH HORMONE, SOMATROPIN)
6971 I II 5/12/1987 AVATAR CORP SOYBEAN OIL, USP
6972 A II 5/13/1987 SPECGX LLC IOVERSOL
6973 I II 5/15/1987 PACO PHARMACEUTICAL SERVICES INC TRANSDERMAL MANUFACTURING FACILITY AT
LAKEWOOD, NEW JERSEY
6974 I II 5/2/1987 CONTRAPAK CORP CONTRACT PACKAGING FACILITY IN WAYNE,
PENNSYLVANIA
6975 I II 5/12/1987 MCGAW INC CYOCTOL PURIFIED
6976 I II 5/5/1987 NATL INST HLTH CONTRACEPTIVE DEV [D-TRP6, PRO9-NHET] GNRH
BRANCH
6977 I II 4/10/1987 MALLINCKRODT CHEMICAL INC OXYCODONE TEREPHTHALATE-D
6978 I II 5/19/1987 PROGRAPHARM LABORATORIES FACILITES AND PERSONNEL AT CHATEAUNEUF-
EN-THYMERAIS, FRANCE
6979 A II 5/5/1987 SOCIETA ITALIANA MEDICINALI ATENOLOL
SCANDICCI SIMS SRL
6980 I II 5/7/1987 AMILCO CORP PR MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF GLASS CONTAINERS IN
PUERTO RICO.
6981 A II 5/27/1987 YUNG ZIP CHEMICAL IND CO LTD DICLOFENAC SODIUM
6982 A II 5/27/1987 YUNG ZIP CHEMICAL IND CO LTD MICONAZOLE NITRATE
6983 A II 5/22/1987 PCAS TIMOLOL MALEATE
6984 I II 5/8/1987 CHEMAPOL LTD BROMOCRIPTINE MESYLATE
6985 I II 5/1/1987 TIM PLASTICS INC FACILITIES FOR MANUFACTURING HIGH
DENSITY POLYETHYLENE BOTTLES
6986 I II 5/26/1987 BAUSCH AND LOMB INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN GREENVILLE, SOUTH
CAROLINA.
6987 I II 5/19/1987 ALCOLAC INC CHLORHEXIDINE GLUCONATE
6988 I II 5/27/1987 SANDOZ GMBH SACA SODIUM SALT
6989 A II 5/29/1987 COPPERHEAD INVESTMENTS INC SDM 88 ® (10% NITROGLYCERIN IN SOLVATED
ACRYLATE BASED ADHESIVE)
6990 I II 5/27/1987 MEDEA RESEARCH LABORATORIES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PORT JEFFERSON STATION,
NEW YORK.
6991 I II 5/28/1987 ROHM AND HAAS CO BIOCRYL BPA-5050PMN
Page 220
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
6992 I II 5/28/1987 ELAN PHARM RES CORP THEOPHYLLINE CONTROLLED RELEASE BEADS
Page 223
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7084 I II 7/20/1987 EI DUPONT DE NEMOURS AND CO INC IRON-59 AS FERRIC CHLORIDE AND FERROUS
CITRATE
7085 I III 7/28/1987 GRAPHIC PACKAGING CORP PRINTED & LAMIN ROLL STOCK FLEXIBLE PACK
MATL & PREF BAGS -
7086 I IV 7/28/1987 VERTELLUS PERFORMANCE MATERIALS TRIETHYL CITRATE FCC
INC
7087 I III 7/27/1987 HERCULES INC NC-603R POLYPROPYLENE RESIN
7088 I II 7/24/1987 LABOCHIM BROMOCRIPTINE MESYLATE
7089 I II 7/29/1987 NIPPON GOHSEI ALUMINUM SUCROSE SULFATE
7090 A II 7/28/1987 NORDMARK ARZNEIMITTEL GMBH AND PANCRELIPASE
CO KG
7091 I II 7/28/1987 FIRMA KNOLL AG NORDMARK PHARMACEUTICAL PROD. FACIL. IN
UETERSEN, W. GERMANY
7092 A III 7/31/1987 MULTISORB TECHNOLOGIES INC MINIPAX DESSICANT PACKETS
7093 I I 8/7/1987 RORER PHARM CORP SUB RORER FACILITIES, PERSONNEL AND PROCEDURES IN
GROUP FORT WASHINGTON, PA
7094 A II 8/4/1987 CAMBREX PROFARMACO MILANO SRL ALPRAZOLAM
7095 I II 8/4/1987 PHARMACIA AND UPJOHN SUB PFIZER BETAMETHASONE DIPROPIONATE
INC
7096 A II 8/4/1987 OLON SPA MAPROTILINE HYDROCHLORIDE
7097 I II 8/7/1987 ALCAN FOLIEN GMBH FACILITIES FOR THE G. OF PACKAGING
MATERIALS IN W. GERMANY
7098 I II 8/7/1987 ADVANCED MAGNETICS INC FACILITIES, PERSONNEL AND OPERATING
PROCEDURES IN CAMBRIDGE,MA
7099 A II 8/6/1987 ASPEN OSS BV BUPRENORPHINE HYDROCHLORIDE
7100 I II 8/4/1987 3M PHARMACEUTICALS METHENAMINE HIPPURATE
7101 I II 8/6/1987 ASTRAZENECA PHARMACEUTICALS LP ATENOLOL ACETATE
7102 I II 8/7/1987 FDC PRIVATE LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MAHARASHTRA STATE, INDIA.
7103 I II 8/10/1987 ASHOK ORGANIC INDUSTRIES LTD MICROCRYSTALLINE CELLULOSE POWDER
7104 I I 8/6/1987 WARNER LAMBERT CO LLC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BROCKVILLE, ONTARIO,
CANADA.
7105 A V 7/27/1987 PFIZER MANUFACTURING BELGIUM NV PUURS ASEPTIC MANUFACTURING FACILITY
7106 I III 8/14/1987 MULTISORB TECHNOLOGIES INC DRICAP®
7107 I II 8/10/1987 WISCONSIN ANALYTICAL AND DETERMINATION OF PSEUDOEPHEDRINE IN
RESEARCH SERVICES LTD HUMAN PLASMA
7108 I II 8/11/1987 3M PHARMACEUTICALS ORPHENADRINE CITRATE
7109 I II 8/11/1987 HUNTINGTON LABS INC 20% CHLORHEXIDINE GLUCONATE
7110 A II 8/18/1987 SANDOZ GMBH LIOTHYRONINE SODIUM
7111 I II 8/17/1987 MYLAN INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PUERTO RICO.
Page 224
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7112 I II 4/30/1987 RP SCHERER NORTH AMERICA DIV RP MCN-5691
SCHERER CORP
7113 I III 8/14/1987 POLYCON INDUSTRIES INC PLASTIC BOTTLES
7114 A IV 8/17/1987 DDP SPECIALTY ELECTRONIC DOW CORNING™ BIO-PSA AMINE-COMPATIBLE
MATERIALS US 9 LLC PRESSURE SENSITIVE ADHESIVE
7115 A II 8/24/1987 SANDOZ GMBH CTAZ-TBE (CEFTAZIDIME-TERT-BUTYLESTER)
7116 I III 8/19/1987 COURTESY MEDTEK PACKAGING FOR HUMAN DRUGS AND
BIOLOGICS
7117 I I 8/18/1987 RORER PHARM CORP FACILITIES, PERSONNEL AND PROCEDURES IN
MANATI, PUERTO RICO
7118 I II 8/20/1987 ALLIED SIGNAL INC FLUOROCARBON
7119 I II 8/28/1987 FOREST LABORATORIES INC SODIUM MONOFLUOROPHOSPHATE 76 MG. C.R.
TABLETS
7120 I II 8/27/1987 ISOCHEM SA FENOPROFEN CALCIUM USP
7121 I II 8/26/1987 SCHERING AG PANCURONIUM BROMIDE
7122 I II 8/24/1987 BACHEM FEINCHEMIKALIEN AG BOC-THR(BZL)-D-GLU(OBZL)-NH2
7123 I III 8/25/1987 NORTON PERFORMANCE PLASTICS TFE/PU LAMINATE
CORP
7124 I II 8/27/1987 TANABE SEIYAKU CO LTD TA-3090
7125 I II 8/31/1987 QUATRUM BETAMETHASONE DIPROPIONATE
7126 I II 8/21/1987 AVATAR CORP SAFFLOWER OIL
7127 I II 8/17/1987 IFP INC SULFASALAZINE STARCH POWDER
7128 I I 8/28/1987 WARNER LAMBERT CO LLC MANUFACTURING FACILITY IN PONTYPOOL,
GWENT, UNITED KINGDOM
7129 A III 9/3/1987 DAIICHI GLASS CO LTD GLASS BOTTLES
7130 I II 8/25/1987 FABBRICA ITALIANA SINTETICI SPA PIROXICAM
7131 I II 9/4/1987 NOBEL CHEMICALS AB DIV FINE NAPROXEN SODIUM USP
CHEMICALS INC
7132 I II 9/4/1987 ALCHYMARS SPA TRANYLCYPROMINE SULFATE USP
7133 I II 9/4/1987 BLASCHIM SPA ATENOLOL
7134 I II 8/31/1987 ERCI FACILITIES SERVICES CORP FACILITIES IN ROCKVILLE, MD FOR STORAGE-
NCI CONTRACT #N01-CN-65002
7135 I II 8/31/1987 RALLIS INDIA LTD NAPROXEN
7136 I I 8/31/1987 CHEMAPOL LTD GALENA N.P., A CO. OF SPOFA-FACILITIES,
OPAVA-KOMAROV, CZECHOSLOVAKIA
7137 I II 9/4/1987 DELMAR CHEMICALS INC TACRINE HYDROCHLORIDE MONOHYDRATE
7138 I II 9/4/1987 EXTAL PTY LTD DIV JOHNSON AND NALOXONE HYDROCHLORIDE
JOHNSON
7139 I II 9/10/1987 ABBOTT LABORATORIES CHEMICAL AND TUBOCURARINE CHLORIDE
AGRICULTURAL PRODUCTS DIV
7140 I III 9/14/1987 NAN YA PLASTICS CORP USA XAH FILM AND SHEET MATERIAL
7141 I II 9/14/1987 ZENECA PHARMACEUTICALS LISINOPRIL DIHYDRATE
7142 I II 9/3/1987 UNILEVER UNITED STATES INC ENCAPSULATED CALCIUM CARBONATE
7143 I II 9/10/1987 BACHEM FEINCHEMIKALIEN AG MANUFACTURE OF ANARITIDE ACETATE
Page 225
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7144 I I 9/14/1987 STROLLE RESEARCH & DEVELOPMENT FACILITIES AND PROCEDURES IN CINCINNATI,
CORP OHIO
7145 A II 9/17/1987 JOHNSON MATTHEY INC CARBOPLATIN
7146 I II 9/8/1987 LUSOCHIMICA SPA PRODUCTION AND CONTROL METHODS FOR
THE
7147 I II 9/17/1987 PFANSTIEHL LABORATORIES INC L-RHAMNOSE
7148 I II 9/16/1987 VIS FARMACEUTICA FACILITIES, PERSONNEL AND CONTROLS IN
PADOVA
7149 I IV 9/14/1987 ALDRICH CHEMICAL CO INC ROSE BENGAL
7150 I II 9/17/1987 SEKISUI CHEMICAL CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN YAMAGUCHI, JAPAN.
7151 A II 9/22/1987 TEVA PHARMACEUTICAL INDUSTRIES METOPROLOL TARTRATE
LTD
7152 I II 9/24/1987 FRANCIS SPA FENOPROFEN CALCIUM
7153 I II 9/24/1987 SYLATEC GROUPE SYNTHELABO KETO ACID MIXTURE "EE" FORMULA MB 235G06
7154 I II 9/25/1987 SUMITOMO CHEMICAL CO LTD PRAZOSIN HYDROCHLORIDE
7155 A III 9/1/1987 DAIKYO SEIKO LTD PHARMACEUTICAL RUBBER ITEMS
7156 I II 9/29/1987 EZ PAP INC DIRECTLY COMPRESSIBLE ACETAMINOPHEN
73% (E-Z 180)
7157 I II 9/25/1987 GD SEARLE AND CO HALOPERIDOL
7158 I II 9/23/1987 PFANSTIEHL LABORATORIES INC UREA PEROXIDE, U-102
7159 I V 9/29/1987 NATIONAL INSTITUTES HEALTH CURRICULUM VITAES
NATIONAL INSTITUTE ALLERGY
INFECTIOUS DISEASES
7160 I II 9/25/1987 NISSEI CHEMICAL INDUSTRY CO LTD FACILITIES, PRODUCTION AND CONTROLS FOR
Page 226
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7173 I IV 10/5/1987 STERLING ORGANICS DIV STERLING MACROSORB I MATERIALS
DRUG INC
7174 I II 10/12/1987 CIPLA LTD PROPANALOL HYDROCHLORIDE
7175 I II 10/13/1987 PRODESFARMA QUIMICA SL ATENOLOL
7176 I III 10/8/1987 MULTISORB TECHNOLOGIES DRICAP PLUS
7177 I II 10/2/1987 NAPP TECHNOLOGIES INC SULFAMETHOXAZOLE
7178 I II 10/6/1987 ERREGIERRE SPA METOPROLOL BASE
7179 I II 10/8/1987 TEIKOKU CHEM INDUSTRY FLUOROURACIL
7180 I III 10/9/1987 NUODEX INC ADMEX 760 POLYMERIC PLASTICIZER
7181 I II 10/9/1987 PFIZER CENTRAL RESEARCH FACILITIES, PERSONNEL & EQUIPMENT IN
SANDWICH, KENT, ENGLAND
7182 I II 10/9/1987 AMSA ANONIMA MEDICINALI SINTETICI MANUFACTURING SITE, FACILITIES,
AND AFFINI SPA PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MILANO, ITALY.
7183 I II 10/14/1987 WYCKOFF CHEMICAL CO INC DOXAPRAM HYDROCHLORIDE
7184 I V 10/12/1987 GIVAUDAN CORP CLINICAL STUDIES REGARDING THE USE OF
PARSOL MCX
7185 I I 10/16/1987 FISONS CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES
7186 I II 11/3/1987 ISTITUTO CHEMICOTHERAPICO SUCRALFATE
ITALIANO
7187 I II 8/17/1987 AVANTI POLAR LIPIDS INC 1,2-DIPALMITOYL-SN-GLYCERO-3-
PHOSPHOCHOLINE
7188 A II 10/13/1987 PCAS PINDOLOL
7189 I II 10/20/1987 INNOVATIVE FOOD PROCESSORS INC DIETHYLCARBAMAZINE CITRATE
7190 I II 10/18/1987 ARCHIMICA SPA IMIPRAMINE HYDROCHLORIDE
7191 I III 10/16/1987 PHARMA ELASTOMERE RUBBER PARTS PHE 401/60 GREY
7192 I II 10/19/1987 RAYLO CHEMICALS G. METHODS AND PROPERTIES OF 2'-3'-
DIDEOXYADENOSINE
7193 I II 10/26/1987 DELMAR CHEMICALS INC CLINDAMYCIN PHOSPHATE
7194 I I 10/26/1987 ORGANON INC ORGANIZATION, FACILITIES AND PROCEDURES
IN WEST ORANGE, N.J.
7195 I II 10/16/1987 CADILA LABORATORIES PVT LTD TRIMETHOPRIM
7196 I II 10/28/1987 HEUMANN PCS GMBH MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN FEUCHT, WEST GERMANY.
7197 A II 10/28/1987 ASPEN OSS BV DESOGESTREL
7198 I II 10/22/1987 A AND I LABORATORY MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ARLINGTON, TEXAS.
7199 I II 7/1/1987 FINE CHEMICALS CORP MINOCYCLINE HYDROCHLORIDE
7200 I II 10/21/1987 IMPERIAL CHEMICAL INDUSTRIES PLC ATENOLOL BULK DRUG
7201 I II 10/23/1987 UNILEVER UNITED STATES INC ENCAPSULATED CIMETIDINE DURKOTE 130M-50
AND DURKOTE 145-50
Page 227
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7202 I III 10/5/1987 ALUMINUM CO AMERICA PACKAGING STRUCTURES PHAR 9424 & 9425
7203 I II 10/22/1987 ABBOTT LABORATORIES CHEMICAL AND PRAZOSIN HYDROCHLORIDE USP&PRAZOSIN
AGRICULTURAL PRODUCTS DIV HYDROCHLORIDE,POLYHYDRATE
7204 I II 11/2/1987 CHUGAI PHARMACEUTICAL CO LTD CCA (LOBENZARIT SODIUM) TABLETS
7205 I I 10/21/1987 LEBERCO CELSIS TESTING MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ROSELLE PARK, NEW JERSEY.
Page 228
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7232 I II 11/16/1987 BEECHAM PHARMACEUTICALS FACIL, PERSONNEL & GENL OPER PROCED IN
GREAT BURGH, EPSOM, U.K.
7233 I II 11/16/1987 BEECHAM PHARMACEUTICALS FACIL, PERSONNEL AND GENERAL OPERATING
PROCEDURES IN HARLOW, ESSEX.
7234 I II 11/17/1987 EURAND AMERICA INC CIMETIDINE BASE MICROCAPSULES
7235 A III 11/13/1987 EQUISTAR CHEMICALS LP SUB ALATHON POLYETHYLENE RESIN COMPOUNDS
LYONDELLBASELL
7236 I II 11/16/1987 LISAC SA FACIL, PERSONNEL, EQUIP & PROCEDURES IN
BARCELONA, SPAIN
7237 A II 11/20/1987 SPECGX LLC HYDROMORPHONE HYDROCHLORIDE
7238 I II 11/19/1987 SIPSY CHIMIE FINE SCA TRIMEBUTINE BASE & TRIMEBUTINE MALEATE
7239 A II 11/30/1987 TEVA PHARMACEUTICAL INDUSTRIES DILTIAZEM HYDROCHLORIDE USP
LTD
7240 I II 10/26/1987 TORCAN CHEMICAL LTD DILTIAZEM HYDROCHLORIDE
7241 I II 11/27/1987 ISOCHEM SA ACCEPTANCE TESTING OF HFA-134A(1,1,1,2-
TETRAFLUOROETHANE)
7242 I II 11/9/1987 PROQUINA SA SALAZOSULFAPYRIDINE
7243 I II 12/4/1987 ALLERGAN OPTICAL INC DIV ALLERGAN MIOGAN (ACETYLCHOLINE CHLORIDE FOR
INC OPTHALMIC SOLUTION)
7244 I II 11/7/1987 ALFA CHEMICALS ITALIANA SRL VERAPAMIL HYDROCHLORIDE
7245 I II 12/3/1987 DELMAR CHEMICALS INC NIFEDIPINE
7246 I II 12/7/1987 CORN PRODUCTS BRASIL INGREDIENTS MANNITOL
INDUSTRIAIS LTDA
7247 A IV 12/9/1987 YUNG ZIP CHEMICAL IND CO LTD SODIUM STARCH GLYCOLATE
7248 I II 12/7/1987 DEGUSSA AG WERK RADEBEUL CHLORHEXIDINE ACETATE
7249 I II 12/11/1987 APOTEX PHARMACHEM INC GAMMA-HYDROXYBUTYRATE
7250 I II 12/10/1987 BORREGAARD INDUSTRIES LTD FACILITIES, PERSONNEL & PROCEDURES IN
SARPSBORG, NORWAY
7251 I IV 12/7/1987 UNGERER AND CO ARTIFICIAL GRAPE FLAVOR #18176
7252 I II 12/9/1987 DAINIPPON PHARMACEUTICAL CO LTD ENOXACIN SESQUIHYDRATE
7253 I I 12/9/1988 NATIONAL O RINGS MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN DOWNEY, CALIFORNIA
7254 I II 12/11/1987 WADDINGTON JAYCARE LTD PRODUCTION OF JAYCAPS IN LONDON,
ENGLAND
7255 I II 12/14/1987 QUATRUM TRIAMCINOLONE HEXACETONIDE
7256 I III 12/16/1987 PRO GRAM PLASTICS INC POLYETHYLENE AND POLYPROPYLENE
CONTAINERS
7257 I III 12/2/1987 COURTESY PLASTICS INJECTION MOLDED PARTS
7258 I II 12/8/1987 ACCRA PAC INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ELKHART, INDIANA.
7259 I II 12/21/1987 MACFARLAN SMITH JOHNSON MATTHEY FACILITIES, EQUIPMENT & PROCEDURES IN
PLC BUSINESS BUCKHAVEN,FIFE,SCOTLAND
Page 229
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7260 I IV 12/7/1987 NATIONAL STARCH AND CHEMICAL CO MODIFIED FOOD STARCHES FOR USE AS
PHARMACEUTICAL EXCIPIENTS
7261 I III 10/15/1987 ANDERSON TOOL AND DIE CORP DRY SCRUB BRUSH
7262 I II 12/16/1987 WISCONSIN ANALYTICAL AND CLORAZEPATE
RESEARCH SERVICES LTD
7263 I II 12/23/1987 VERTELLUS PERFORMANCE MATERIALS TRIBUTYL CITRATE
INC
7264 A II 12/22/1987 TEVA PHARMACEUTICAL INDUSTRIES TIMOLOL MALEATE
LTD
7265 I II 12/23/1987 AMSA ANONIMA MEDICINALI SINTETICI ATENOLOL
AND AFFINI SPA
7266 I III 12/7/1987 ZIMMER PAPER PRODUCTS INC INNERSEALS
7267 I II 12/29/1987 DIOSYNTH BV 2-PHENYL-1,3-PROPANEDIOL DICARBAMATE
7268 I II 12/12/1987 YUKI GOSEI KOGYO CO LTD 2' DEOXYCYTIDINE HYDROCHLORIDE (BULK)
7269 I II 12/10/1987 COMPANIA ESPANOLA DE SINTESIS BETAMETHASONE ACETATE
QUIMICA SA
7270 I II 12/18/1987 ALFA CHEMICALS ITALIANA SRL TOLMETIN SODIUM DIHYDRATE
7271 I III 12/28/1987 BF ASCHER AND CO INC PACKAGING MATERIALS
7272 A II 12/31/1987 UNION QUIMICO FARMACEUTICA SA CYCLOPENTOLATE HYDROCHLORIDE
(UQUIFA)
7273 A III 1/7/1988 CONSTANTIA PIRK GMBH & CO KG FLEXIBLE PACKAGING MATERIALS
7274 I II 12/21/1987 PLAISTOW LTD FENOFIBRATE
7275 I II 1/4/1988 SELOC FRANCE XYLAZINE HYDROCHLORIDE
7276 I II 10/20/1987 NIPPON RIKAGAKUYAKUHIN CO LTD CARBOCYSTEINE (S-CARBOXYMETHYL-L-
CYSTEINE)
7277 I II 1/4/1988 GUANGDONG PHARMACEUTICAL TRIMETHOPRIM AND SULFAMETHOXAZOLE
FACTORY
7278 I II 1/1/1988 SIGMA F AND D DIV LTD L-TRYPTOPHAN ETHYL ESTER HCl
7279 I II 10/20/1987 NIPPON RIKAGAKUYAKUHIN CO LTD L-2-OXOTHIAZOLIZINE-4-CARBOXYLIC ACID
7280 I II 1/4/1988 GUANGDONG PHARMACEUTICAL SULFAMETHAZINE
FACTORY
7281 I II 1/5/1988 CHEMWERTH INC DOXYCYCLINE MONOHYDRATE
7282 I II 1/13/1988 NANJING PHARMACEUTICAL FACTORY SUCRALFATE
CO LTD
7283 I II 1/8/1988 PHARM ECO LABORATORIES INC N,N-BIS-(PYRIDOXAL-5-
PHOSPHATE)ETHYLENEDIAMINE-N,N-DIACETIC
ACID
7284 I II 1/14/1988 LION CORP GLYCERIDE OF PENTADECANOIC ACID (PDG)
DRUG SUBSTANCE
7285 I II 1/14/1988 LION CORP LKF DRUG PRODUCT
7286 I I 12/18/1987 MERCK SHARP & DOHME CAGUAS MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CAGUAS, PUERTO RICO.
7287 I II 1/6/1988 BLASCHIM SPA TRAZODONE HYDROCHLORIDE
Page 230
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7288 I II 1/5/1988 AMERICAN CHEMICAL INDUSTRIAL CARBAMAZEPINE
CORP
7289 I II 1/5/1988 AMERICAN CHEMICAL INDUSTRIAL CLINDAMYCIN HYDROCHLORIDE
CORP
7290 I II 1/6/1988 MINNTECH CORP WATER FILTER
7291 I II 1/8/1988 NORAMCO INC CHLORZOXAZONE
7292 I II 1/15/1988 LEIRAS PHARMACEUTICALS QUINIDINE GLUCONATE EXTENDED RELEASE
GRANULES
7293 I II 12/1/1987 SIGMA F AND D DIV LTD AMETHOPTERIN (METHOTREXATE)
7294 I II 1/19/1988 IMAGENTS INC FACILITIES, PERSONNEL AND OPERATING
PROCEDURES IN HOUSTON, TX
7295 I II 2/2/1988 PFANSTIEHL LABORATORIES INC D-GALACTOSE
7296 I II 12/29/1987 RALLIS INDIA LTD IBUPROFEN U.S.P.
7297 I III 1/22/1988 CUNO INC ZETAPREP SP MEDIA
7298 I II 11/1/1987 FINE CHEMICALS CORP TOLAZOLINE HYDROCHLORIDE
7299 I II 1/25/1988 SIFAVITOR SPA LOPERAMIDE HYDROCHLORIDE
7300 I II 1/22/1988 CUNO INC ZETAPREP DEAE MEDIA
7301 I II 1/6/1988 BOEHRINGER INGELHEIM PHARMA KG THEOPHYLLINE MONOHYDRATE
7302 I III 1/2/1988 CUNO INC ZETAPREP QEA MEDIA
7303 I V 12/30/1987 MOVA PHARMACEUTICAL CORP STERILE FINISHED PRODUCTS AND STERILE
PROCESSING OPERATIONS LOCATED IN
CAGUAS, PUERTO RICO
7304 I II 1/22/1988 EASTMAN KODAK CO AML ASEPTIC PROCESSING WAREHOUSING
AND LABORATORIES
7305 I II 1/26/1988 MITCHELL COTTS CHEMICALS LTD FACILITY AT MIRFIELD, UK
7306 A II 1/27/1988 MOEHS IBERICA SL METOPROLOL TARTRATE
7307 I II 1/29/1988 BASF CORP BIS-2-ETHYLHEXYL PHTHALATE
7308 I I 12/17/1987 SIPHARM SUB OF SELOC AG FACILITIES, PERSONNEL AND PROCEDURES IN
SISSELN, SWITZERLAND
7309 I I 2/1/1988 FORMULATION DEVELOPMENT CO FACILITIES, PERSONNEL AND PROCEDURES IN
WILMINGTON, N.CAROLINA
7310 I II 2/2/1988 HOECHST MARION ROUSSEL SA BETAMETHASONE VALERATE USP, BP
7311 A II 2/2/1988 EXCELLA GMBH AND CO KG BACLOFEN
7312 I II 1/27/1988 SWISS CAPS AG FACILITIES, PERSONNEL AND PROCEDURES IN
KIRCHBERG, SWITZERLAND
7313 I II 2/1/1988 CHEMISCHE FABRIK WEYL GMBH ACETYLSALICYLIC ACID
7314 I II 2/2/1988 REXIM SA DIV DEGUSSA AG L-AMINO ACIDS
7315 I II 2/1/1988 STERIS LABORATORIES INC FACILITIES & STANDARD OPERATING
PROCEDURES IN ARIZONA
7316 I II 2/2/1988 REXIM SA DIV DEGUSSA AG N-ACETYL L-TYROSINE
7317 I II 2/4/1988 WISCONSIN ANALYTICAL AND DETERMINATION OF OXAZEPAM IN HUMAN
RESEARCH SERVICES LTD PLASMA
7318 I II 1/15/1988 BRADY ENTERPRISES INC MANUFACTURING FACILITIES AND
PROCEDURES IN E. WEYMOUTH, MA.
Page 231
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7319 I II 1/28/1987 THERMO PAK CO INC FACILITIES AND PROCEDURES IN WOOD DALE,
ILLINOIS
7320 I II 2/5/1988 3M PHARMACEUTICALS FACILITIES, PERSONNEL AND PROCED. IN
PITHIVIERS, CEDEX, FRANCE
7321 I II 2/10/1988 SOLOPAK LABORATORIES INC FACILITIES, PERSONNEL AND PROCEDURES IN
ELK GROVE VILLAGE, IL.
7322 I II 2/9/1988 RESEARCH BIOCHMICALS INC SKF-38393 HCl AS ENCAPSULATED AT
NORTHEASTERN UNIV.,BOSTON,MA
7323 I II 2/10/1988 DIOSYNTH BV STERILE PROCESSING FACILITY IN JAPAN
7324 A II 2/5/1988 PUROLITE CORP CHOLESTYRAMINE RESIN USP
7325 I III 1/25/1988 HUNTSMAN CHEMICAL CORP POLYPROPYLENE
7326 I III 2/16/1988 4P VERPACKUNGEN RONSBERG GMBH FLEXIBLE FOIL LAMINATE
7327 I II 2/16/1988 IMAGENTS INC RADIOCHEMICAL INDIUM CHLORIDE IN-111
7328 I II 2/9/1988 ORGANICS DIV LA GRANGE INC CONJUGATED ESTROGENS FOR INJECTION USP
POWDER - CHICAGO, IL.
7329 A II 2/12/1988 SIEGFRIED EVIONNAZ SA CHOLINE-SALICYLATE 80%
7330 I II 2/8/1988 HOECHST CELANESE CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BISHOP, TEXAS.
7331 I II 1/20/1988 NIPPON KAYAKU CO LTD BUTADIAMUPLATIN
7332 I II 2/16/1988 GEDEON RICHTER LTD NORETHINDRONE 0.5 MG. AND ETHINYL
ESTRADIOL 0.035
7333 A II 2/8/1988 SIEGFRIED EVIONNAZ SA METHENAMINE HIPPURATE
7334 I II 2/9/1988 BOEHRINGER INGELHEIM PHARMA KG ATROPINE METHYLNITRATE
7335 I II 2/18/1988 GLAXO WELLCOME INC FACILITY LOCATED IN EDINBURG, SCOTLAND
7336 I II 2/5/1988 COSMA SPA TOLMETIN SODIUM
7337 I II 2/19/1988 NANTONG GENERAL PHARMACEUTICAL 5-FLUOROURACIL
FACTORY
7338 I II 2/19/1988 HEXACHIMIE SA CIBENZOLINE SUCCINATE INN. OR CIFENLINE
SUCCINATE USAN
7339 I II 2/17/1988 GREAT LAKES CHEMICAL KONSTANZ L-AMINO ACID
GMBH
7340 A II 2/17/1988 TEVA PHARMACEUTICAL INDUSTRIES LOPERAMIDE HYDROCHLORIDE
LTD
7341 I II 2/25/1988 ORION CORP FARMOS CHEMICAL PLANT CYCLOPHOSPHAMIDE 50 MG. TABL.
Page 236
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7482 I II 5/18/1988 SIGMA F AND D DIV LTD TES(N-tris[ HYRDOXYMETHYL ] methy 2-
aminoethanesulfonic acid)
7483 I II 5/18/1988 KV PHARMACEUTICAL CO PSEUDOEPHEDRINE HCl CONTROLLED BEADS
7484 I II 5/10/1988 AVENTIS BEHRING GMBH HPLC PURIFIED CALCITONIN-SALMON DRUG
SUBSTANCE
7485 A II 5/16/1988 OLON SPA ISOTRETINOIN
7486 I II 5/17/1988 HEUMANN PCS GMBH HALOPERIDOL
7487 I II 5/20/1988 REPLIGEN CORP ULTRAPURE RECOMBINANT PROTEIN A
7488 I II 5/16/1988 SIGMA F AND D DIV LTD SUCCINIC ACID,DISODIUM HEXAHYDRATE
7489 I II 5/20/1988 REPLIGEN CORP IMMOBILIZED RECOMBINANT PROTEIN A
7490 I II 5/20/1988 FINORGA 6-METHOXY-2-NAPHTHALDEHYDE
7491 I II 5/20/1988 REPLIGEN CORP THERAPEUTIC RECOMBINANT PROTEIN A
7492 A II 5/22/1988 CHEMI SPA DIFLUNISAL
7493 I II 4/30/1988 LONZA BRAINE SA DESMOPRESSIN ACETATE
7494 I II 5/26/1988 SHANGHAI NO 17 PHARMACEUTICAL INDOMETHACIN
FACTORY
7495 A II 5/30/1988 OLON SPA PYRANTEL PAMOATE
7496 I IV 5/25/1988 WEI MING PHARMACEUTICAL G CO LTD MICROCRYSTALLINE CELLULOSE
7497 I II 5/31/1988 BIOGLUCONICS INC FERROUS GLUCONATE
7498 I II 5/27/1988 FARMABOIS DESOXIMETHASONE
7499 I II 5/26/1988 ICFI SPA BACLOFEN
7500 I II 5/16/1988 PENINSULA LABS INC BETA-HUMAN CHORIONIC-GONADOTROPIN
(109-145) IN BELMONT, CA
7501 I II 6/2/1988 QUATRUM BECLOMETHASONE DIPROPIONATE
7502 I II 6/1/1988 MEDISORB TECHNOLOGIES TESTOSTERONE INJECTABLE MICROSPHERES
INTERNATIONAL LTD PARTNERSHIP
7503 I II 5/30/1988 NOBEL CHEMICALS AB DIV FINE FLUOCINONIDE
CHEMICALS INC
7504 A II 6/3/1988 MOEHS IBERICA SL NIFEDIPINE
7505 A II 6/1/1988 FIS FABBRICA ITALIANA SINTETICI SPA CLONAZEPAM
7506 I III 5/31/1988 SILGAN PLASTICS CORP PLASTIC BOTTLES
7507 I IV 6/2/1988 SHIN-ETSU CHEM IND CO LTD HYDROXYPROPYL METHYLCELLULOSE
ACETATE SUCCINATE
7508 I II 6/1/1988 EXPANSIA CICLETANINE
7509 I IV 6/1/1988 ABITEC CORP BBS, BAKER'S BEST SHORTENING
7510 I II 6/3/1988 PENCO OF LYNDHURST INC FACILITY, PERSONNEL AND PROCEDURES IN
LYNDHURST, NEW JERSEY
7511 I III 6/9/1988 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMUATION B5001-55
GRAY, SALISBURY, MD
7512 I II 6/6/1988 ERCI FACILITIES SERVICES CORP STORAGE OF CHEMICALS AND DRUGS FOR NCI
CONTRACT (N01-CM-73721)
7513 I II 6/7/1988 NOVARTIS PHARMACEUTICALS CORP STARTING MATERIALS 1 & 3, IN NEW JERSEY
AND SWITZERLAND
7514 I II 6/3/1988 ER SQUIBB AND SONS INC FUNGILIN (AMPHOTERICIN B) ORAL
SUSPENSION
Page 237
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7515 I II 5/19/1988 FARCHEMIA SRL N-METHYL-1-METHYLTHIO-2-NITRO
ETHENAMINE, TREVIGLIO, ITALY
7516 I II 6/6/1988 BOSTON ANALYTICAL INC MANUFACTURING SITE, FACILITIES,
PERSONNEL AND GENERAL OPERATING
PROCEDURES IN EVERETT, MA.
7517 I II 6/8/1988 BACHEM FEINCHEMIKALIEN AG H-PHE-0ME HYDROCHLORIDE
7518 I II 6/10/1988 SOGO PHARMACEUTICAL CO LTD THIOTEPA
7519 A III 6/9/1988 AMPAC FLEXIBLES PACKAGING MATERIALS
7520 I II 6/8/1988 BIORESEARCH SPA ENTERIC COATED 400 mg TABLET
7521 I IV 6/6/1988 UNILEVER UNITED STATES INC EXCIPIENTS FOR CREAMTEX
7522 I II 6/6/1988 OMNICHEM SA TERMINAL STERILIZATION PROGRAM IN GRAND
ISLAND, NEW YORK.
7523 I II 6/8/1988 CHEMISCHE FABRIK BERG GMBH METHENAMINE HIPPURATE
7524 I II 6/13/1988 DIOSYNTH BV DEHYDRO ISOANDROSTERONE ACETATE
7525 A II 6/12/1988 STEROGENE BIOSEPARATIONS INC PURIFICATION CHROMATOGRAPHY MEDIA USED
IN THE PREPARATION OF PROTEINS
7526 I II 6/13/1988 SIGMA F AND D DIV LTD DEXTROMETHORPHAN HYDROBROMIDE
7527 I II 6/14/1988 JOHNSON MATTHEY INC GALLIUM NITRATE
7528 I II 6/14/1988 SHANGHAI NO 6 PHARMACEUTICAL RANITIDINE HYDROCHLORIDE
FACTORY
7529 I II 6/13/1988 DIOSYNTH BV METOLAZONE
7530 I III 6/8/1988 SILGAN PET CORP PACKAGING MATERIALS
7531 I II 6/13/1988 IMAGENTS INC RADIOCHEMICAL GALLIUM CITRATE Ga-67
7532 I II 6/13/1988 DIOSYNTH BV DEHYDRO ISOANDROSTERONE SODIUM
SULPHATE
7533 I II 5/23/1988 ANTIBIOTICOS SPA CABERGOLINE A DRUG SUBSTANCE
7534 I II 5/23/1988 ANTIBIOTICOS SPA CABERGOLINE FINISHED DOSAGE
7535 I II 6/13/1988 DIOSYNTH BV DEHYDRO ISOANDROSTERONE
7536 I II 5/17/1988 LINNEA PHYTOCHEMICALS PILOCARPINE HYDROCHLORIDE
7537 I III 4/28/1988 REEMAY INC SPUNBONDED POLYESTER
7538 I II 6/6/1988 ANGELINI FRANCESCO ACR G. SITE AND FACILITIES LOCATED IN APRILIA
(LT) ITALY
7539 I II 6/9/1988 INDUSTRIE CHIMICHE FARMACEUTICHE DROPERIDOL
ITALIANE SPA
7540 I II 6/16/1988 SIEGFRIED AG DILTIAZEN HYDROCHLORIDE
7541 I II 6/21/1988 SHANGHAI NO 6 PHARMACEUTICAL CIMETIDINE
FACTORY
7542 I II 6/2/1988 ANTIBIOTICOS SPA THYMIC HUMORAL FACTOR GAMMA 2 A DRUG
SUBS. - MILAN,ITALY
7543 I II 6/2/1988 ANTIBIOTICOS SPA THYMIC HUMORAL FACTOR GAMMA 2 FINISHED
DOSAGE, MILAN ITALY
7544 I II 6/15/1988 FARMOS GROUP LTD MEDIPOLAR CYTARABINE
7545 I II 6/21/1988 SHOWA DENKO KK L-5-HYDROXYTRYPTOPHAN
7546 I III 6/9/1988 AIR PRODUCTS AND CHEMICALS INC AIRFLEX 416 EMULSION
Page 238
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7547 I II 6/22/1988 INDUSTRIE CHIMICHE FARMACEUTICHE ECONAZOLE NITRATE
ITALIANE SPA
7548 A II 6/21/1988 FIS FABBRICA ITALIANA SINTETICI SPA CLOTRIMAZOLE
7549 I II 6/21/1988 KNOLL AG MEFLOQUINE HYDROCHLORIDE
7550 I III 6/22/1988 DYMAX CORP PACKAGING MATERIALS ADHESIVES
7551 I II 6/21/1988 NORTHEAST GENERAL MANUFACTURING SITE, FACILITIES,
PHARMACEUTICAL FACTORY PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SHENYANG, PEOPLE'S REP.
OF CHINA (#2 AFFILIATED PLANT).
7552 I II 6/21/1988 NORTHEAST PHARMACEUTICAL GROUP SUCRALFATE
CO LTD
7553 I II 6/24/1988 SELOC FRNCE DIVALPROEX SODIUM
7554 I II 6/27/1988 CONTENSIO CHEMICALS GMBH FACILITY LOCATED AT WITTEN/RUHR, WEST
GERMANY
7555 I II 6/29/1988 EASTMAN KODAK CO (ETHYLENEDINITRILO) TETRAACETIC ACID
COPPER DISODIUM SALT
7556 I II 6/30/1988 HOECHST MARION ROUSSEL SA BETAMETHASONE
7557 A II 6/22/1988 TCI AMERICA DICHLOROACETIC ACID SODIUM SALT
7558 A III 6/28/1988 EXXONMOBIL CHEMICAL CO LOW DENSITY POLYETHYLENE
7559 I IV 6/8/1988 JAY FLAVORS ARTIFICIAL FLAVOR FOR ANTIBIOTIC SPRAY
DRIED NV-7757
7560 I II 6/29/1988 AB COWLES CO INC FACILITIES AND OPERATING PROCEDURES AT
THE WAYLAND PLANT, N.Y.
7561 I I 7/4/1988 IROPHARM LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ARKLOW, IRELAND.
7562 I II 6/28/1988 PENICK CORP OPIUM TINCTURE SOLUTION
7563 I II 7/4/1988 IROPHARM LTD NIFEDIPINE
7564 A II 7/1/1988 PARKER HANNIFIN MANUFACTURING MICROPORUS FILTERS
LTD DOMNICK HUNTER PROCESS
FILTRATION EUROPE
7565 I II 7/4/1988 LABORATOIRES DETUDES ET DE CD271
RECHERCHES SYNTHELABO
7566 I II 5/9/1988 FILTRON TECHNOLOGY CORP FACILITIES LOCATED IN CLINTON,
MASSACHUSETTS
7567 I II 7/1/1988 ANGUS BIOTECH INC ERYTHROMYCIN
7568 A II 7/11/1988 DAIICHI SANKYO CO LTD PRAVASTATIN SODIUM DRUG SUBSTANCE
7569 I II 7/13/1988 RALLIS INDIA LTD NAPROXEN SODIUM
7570 I III 7/7/1988 MAGENTA CORP POP-LOK CAPS
7571 I II 7/6/1988 PAUL SCHERRER INSTITUTE STRONTIUM Sr-82 CONCENTRATE
7572 I I 7/6/1988 PAUL SCHERRER INSTITUTE FACILITIES LOCATED IN WURENLINGEN,
SWITZERLAND
7573 I II 7/6/1988 SMITHKLINE BEECHAM PENN CHEMICALS PRODUCTION FACILITY IN
PHARMACEUTICALS COUNTY CORK, IRELAND
7574 I II 7/6/1988 POLYPEPTIDE LABORATORIES INC ANTOCIN
Page 239
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7575 I II 7/12/1988 RESOLUTION CHEMICALS LTD AZATHIOPRINE
7576 I II 7/19/1988 REXIM SA DIV DEGUSSA AG GLYCINE HYDROCHLORIDE
7577 I II 7/11/1988 MIKAH PHARMA LLC LOXAPINE SUCCINATE
7578 I II 7/7/1988 PHARMACHIM ECONOMIC CORP TOBRAMYCIN BASE
7579 I II 7/18/1988 MEDICHEM SA PROBUCOL
7580 I II 7/15/1988 IPCA LABORATORIES PRIVATE LTD FACILITY IBD-D IN PIN., INDIA
7581 A II 7/15/1988 IPCA LABORATORIES LTD METOCLOPRAMIDE HCL USP
7582 I II 7/18/1988 OWENS ILLINOIS CLOSURE INC FACILITY LOCATED IN FORT WORTH, TEXAS
7583 A II 7/19/1988 INSTITUTO MASSONE S A MENOTROPIN
7584 I II 6/29/1988 SCHERING AG DANAZOL
7585 I II 7/14/1988 EGIS PHARMACEUTICALS PRIVATE LTD PIROXICAM
7586 I II 7/12/1988 SINTENOVA SA ATENOLOL
7587 I II 6/27/1988 RHONE POULENC RORER SPIRAMYCIN SYRUP
PHARMACEUTICALS INC
7588 I II 7/6/1988 STOLLE RESEARCH AND DEVELOPMENT NORETHINDRONE INJECTABLE MICROSPHERES
CORP - CINCINNATI, OHIO
7589 I II 7/13/1988 DS INDUSTRIE APS FACILITY FOR THE PRODUCTION OF LIPID
ESTERS,COPENHAGEN,DENMARK
7590 A II 7/18/1988 MENADIONA SL CLOMIPHENE CITRATE
7591 I II 7/22/1988 FRANCIS SPA ATENOLOL
7592 I II 7/18/1988 SANDOZ LTD PHARMACEUTICAL DIV THIETHYLPERAZINE MALEATE
CHEMICAL DEVELOPMENT
7593 I II 7/13/1988 TANABE SEIYAKU CO LTD BENZYL S-1,2,3,4-TETRAHYDROISOQUINOLINE-
3-CARBOXYLATE P-TOLUENESULFONIC ACID
SALT (THIQ)
7594 I II 7/20/1988 PHARMACEUTICAL DELIVERY SYSTEMS G. SITE, PERSONNEL AND PROCEDURES IN
INC CHESTERFIELD, MO
7595 I II 7/12/1988 BAXTER HEALTHCARE CORP FACILITIES IN MORTON GROVE, IL AND
BRIDGEPORT, NJ
7596 I IV 7/14/1988 SCHER CHEMICALS INC DIISOPROPYL DIMERATE
7597 I II 6/27/1988 AJINOMOTO CO INC INTRAVENOUS LENTINAN
7598 I II 7/29/1988 FINE CHEMICALS CORP PTY LTD PROCHLORPERAZINE DIMALEATE
7599 A II 7/21/1988 COSMA SPA KETOPROFEN
7600 A II 7/18/1988 FIS FABBRICA ITALIANA SINTETICI SPA DILTIAZEM HYDROCHLORIDE
7601 I II 7/29/1988 FUJISAWA PHARMACEUTICAL CO LTD FK506 (FK900506) DOSAGE FORMS
7602 I I 7/28/1988 SYNTHO RIFA PVT LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN GUJARAT, INDIA.
7603 I II 7/28/1988 SYNTHO RIFA PVT LTD RIFAMPIN
7604 I II 6/30/1988 PROQUINA SA DANAZOL
7605 I II 7/27/1988 SANDOZ PHARMACEUTICALS CORP DIV THIAMYLAL SODIUM
SANDOZ INC
7606 I II 7/28/1988 LINZ INSTITUTE INC IMINODIBENZYL
7607 I II 7/29/1988 BIOMEASURE INC MANUFACTURING FACILITIES LOCATED IN
HOPKINTON, MASSACHUSETTS
Page 240
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7608 I II 7/28/1988 CHEMDEX INC IRON DEXTRAN SOLUTION 5% (50 MG/ML)
7609 I II 8/2/1988 TEVA PHARMACEUTICAL INC CO-POLYMER-1 (COP-1)
7610 A III 8/3/1988 LOPAREX LLC 10976 S 63# BL KFT L/0 4000D/000
7611 I II 8/2/1988 BASF AKTIENGESELLSCHAFT STERILE G FACILITIES IN KVAR SAVA,ISRAEL
7612 I II 8/3/1988 HEINRICH MACK NACHF ALEXAN 1000 MG/20 ML VIAL (5% CYTARABINE
SOLUTION) W. GERMANY
7613 I II 8/2/1988 WISCONSIN ANALYTICAL AND DETERMINATION OF HYDROCHLOROTHIAZIDE
RESEARCH SERVICES LTD IN HUMAN URINE
7614 I II 8/8/1988 CHANTAL PHARMACEUTICAL CORP ETHOCYN
7615 I II 7/29/1988 LABORATOIRES DETUDES ET DE (S)-BETAXOLOL HYDROCHLORIDE INFO TRANS.
RECHERCHES SYNTHELABO TO D 5464 ON 9/2/88
7616 I II 8/8/1988 BENZEX LABORATORIES LTD NAPROXEN
7617 A II 8/2/1988 PMC ISOCHEM AMIODARONE HYDROCHLORIDE
7618 A IV 8/1/1988 LUBRIZOL ADVANCED MATERIALS INC NOVEON AA-1® POLYCARBOPHIL( FORMERLY
CARBOPOL 976)
7619 I II 7/19/1988 WIPF AG MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CH-8604 VOLKETSWIL,
SWITZERLAND
7620 I II 8/9/1988 KABI PHARMACIA AB MICTURO (TERODILINE HYDROCHLORIDE)
12.5MG TABS
7621 I II 7/29/1988 IRFI SPA EASFOSFINA
7622 I II 8/11/1988 ASAHI CHEMICAL INDUSTRY CO LTD 1-(2,4-DIFLUOROPHENYL)-6, 7 DIFLUORO-1,4-
DIHYDRO-4-OXOQUINOLINE-3-CARB
7623 I II 7/25/1988 PYUNGHWA SPECIAL RUBBER CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN KYUNGKI-DO, KOREA.
7624 A III 7/25/1988 PYUNGHWA MEDICAL PRECISION CO ELASTOMERIC CLOSURES
LTD
7625 I II 8/9/1988 MALLINCKRODT PHARMS DIV LEVORPHANOL TARTRATE
MALLINCKRODT INC
7626 I II 8/12/1988 KABI PHARMACIA HEPAR INC NUCLEIC ACIDS
7627 I II 8/15/1988 BACHEM FINE CHEMICALS INC BIOMEASURE SOMATOSTATIN ANALOG
7628 I IV 8/3/1988 JAY FLAVORS FLAVOR FOR ANTIBIOTIC SPRAY DRIED NV-7759,
S. PLAINFIELD, NJ.
7629 I II 8/12/1988 FUJISAWA PHARMACEUTICAL CO LTD FK973 DRUG SUBSTANCE AND DRUG PRODUCT
IN AICHI & OSAKA, JAPAN
7630 I II 7/29/1988 ATOMIC ENERGY CORP ISOTOPE PRODUCTION DEPARTMENT FACILITY
IN KANATA, CANADA
7631 I II 8/5/1988 KV PHARMACEUTICAL CO CLONIDINE HYDROCHLORIDE CONTROLLED
RELEASE CAPSULES 0.2 MG.
7632 I III 8/10/1988 LAWSON MARDON GROUP LTD FOIL LIDDING
7633 I III 8/16/1988 MAR CO INDUSTRIES CORP PACKAGING MATERIALS
7634 I II 8/15/1988 ALDRICH CHEMICAL CO INC 1(2PHENYLETHYL)4(N(2PYRAZYL)2(FUROYLAMI
DO)PIPERIDINE HCl
Page 241
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7635 I II 8/23/1988 WILLIAM WRIGLEY JR CO EXTRA SUGARFREE CHEWING GUM
CONTAINING FLUORIDE - CHICAGO, IL
7636 I I 8/25/1988 ZENECA PHARMACEUTICALS FACILITY LOCATED IN NEWARK, DELAWARE
7637 I III 8/17/1988 ZAPPA PLASTICS INC PACKAGING MATERIALS
7638 I II 8/15/1988 FARMOS GROUP LTD MEDIPOLAR GLYBURIDE
7639 I II 8/17/1988 DINAMITE DIPHARMA SPA PENTOXIFYLLINE
7640 I I 8/22/1988 IODENT CO MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN RANTOUL, ILLINOIS.
7641 I III 8/26/1988 SPA SAFTA ALUMINUM FOIL PACKAGING MATERIALS
7642 I II 8/23/1988 WOCKHARDT LTD NIACIN
7643 I II 8/17/1988 INSTITUTO BIOLOGICO DOXOFYLLINE
CHEMIOTERAPICO SPA DIV UNIBIOS
7644 I III 8/25/1988 COMAR INC PACKAGING MATERIALS
7645 I II 8/22/1988 ALDRICH CHEMICAL CO INC Q1196-9
7646 I II 8/23/1988 MALLINCKRODT CHEMICAL INC DEXTROCET-N2000
7647 I III 3/10/1988 MALLINCKRODT INC WEST COMPANY'S 20MM 890 GREY STOPPER
7648 I II 8/25/1988 ALPHA ONE BIOMEDICALS INC FACILITIES UTILLIZED AT THE FOSTER CITY, CA
LOCATION
7649 I II 6/30/1988 PHARMACIA LEO PHARMACEUTICALS FACILITIES, PERSONNEL AND PROCEDURES IN
HELSINGBORG, SWEDEN
7650 I II 8/23/1988 REXOLIN CHEMS AB PIPERANZINE PHOSPHATE
7651 A II 8/22/1988 ITACEL FARMOQUIMICA LTDA EXPLOSOL A SODIUM STARCH GLYCOLATE NF
7652 I II 8/26/1988 GANES CHEMICALS INC PENNSVILLE DEXBROMPHENIRAMINE MALEATE
7653 I II 8/24/1988 BETATENE LTD BETA CAROTENE
7654 I II 9/2/1988 WYCKOFF CHEMICAL CO INC NICOTINE POLACRILEX
7655 A II 9/1/1988 CAMBREX CHARLES CITY INC 5-AMINOSALICYLIC ACID
7656 I II 8/31/1988 BARRE NATIONAL INC FACILITIES, PERSONNEL AND PROCEDURES IN
BALTIMORE, MD
7657 I II 8/24/1988 VENTURE MOLDED PRODUCTS INC FACILITIES FOR PACKAGING MATERIALS G. IN
WEST TRENTON, NJ
7658 A II 9/6/1988 PFANSTIEHL INC SODIUM DL-LACTATE SOLUTION 60%, USP (S-
110, S110-M)
7659 I II 9/6/1988 QP CORP EGG YOLK PHOSPHATIDYL CHOLINE
7660 I II 8/31/1988 SIBEFAT SPA PIROXICAM
7661 I II 9/12/1988 UNICHEM LABORATORIES LTD DIPHENHYDRAMINE HYDROCHLORIDE
7662 I II 9/7/1988 SIGMA F AND D DIV LTD BRADYKININ ACETATE SALT
7663 I III 9/6/1988 3M PHARMACEUTICALS SCOTCHPAK BRAND FILM NO. X-443
7664 I III 9/8/1988 B BRAUN MEDICAL INC MCGAW 4 LITER PLASTIC CONTAINER
7665 I II 8/22/1988 BEA FILTRI SPA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PERO (MILANO) ITALY.
7666 I III 9/14/1988 ALPHAGARY CORP PACKAGING MATERIALS
7667 I II 9/12/1988 DIOSYNTH BV BETAMETHASONE DIPRIONATE
7668 I II 9/6/1988 ALDRICH CHEMICAL CO INC 6- HYDROXYDOPAMINE HYDROBROMIDE
Page 242
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7669 A II 9/9/1988 COSMA SPA PYRANTEL PAMOATE
7670 I I 9/12/1988 HERBERT LABORATORIES DIV SMITH FACILITIES, SITE AND PERSONNEL UTILLIZED IN
KLINE & FRENCH CO IRVINE, CA
7671 I I 9/14/1988 FAULDING HOSPITAL PRODUCTS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN AGUADILLA, PUERTO RICO.
7672 I III 9/13/1988 ROBERTS AND CARLSON INC LOKFLEX II PRIMER
7673 I II 9/21/1988 BEIERSDORF MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN HAMBURG, WEST GERMANY
FOR MOXONIDINE.
7674 I I 9/14/1988 HR CENCI LABORATORIES INC FACILITIES, PERSONNEL AND PROCEDURES
UTILLIZED IN FRESNO, CA
7675 A II 9/16/1988 CAMBREX PROFARMACO MILANO SRL GLYBURIDE
7676 I II 9/15/1988 REINO CHEMICAL INDUSTRIAL CORP ACETAMINOPHEN
7677 I II 10/21/1988 BOMBAY DRUG HOUSE LTD TRIMETHOPRIM
7678 A II 9/16/1988 DIPHARMA FRANCIS SRL GLYBURIDE
7679 I II 9/15/1988 SIGMA F AND D DIV LTD INSULIN FROM BOVINE PANCREAS
7680 I II 9/23/1988 RAYLO CHEMICALS 2',3'-DIDEOXYINOSINE
7681 I II 9/15/1988 DIBRA SPA FACILITIES UTILIZED IN MILANO, ITALY
7682 I II 9/20/1988 INALCO SPA PURIFIED LACTULOSE SYRUP
7683 I II 9/16/1988 SALARS SPA FACILITIES UTILIZED IN COMO, ITALY
7684 I II 9/16/1988 SALARS SPA BUPRENORPHINE HYDROCHLORIDE
7685 I III 9/16/1988 SOUTHERN RESEARCH INSTITUTE INTRA-ORAL FLUORIDE-RELEASING DEVICES -
BIRMINGHAM, ALABAMA
7686 A II 9/22/1988 CU CHEMIE UETIKON GMBH KETAMINE HYDROCHLORIDE
7687 I II 9/15/1988 SIGMA F AND D DIV LTD INOSINE
7688 I I 8/18/1988 RORER HLTH CARE UK LTD FACILITIES UTILIZED IN EASTBOURNE, EAST
SUSSEX, UK
7689 I II 9/21/1988 SIGMA F AND D DIV LTD ISONICOTINIC ACID HYDRAZIDE
7690 I II 9/21/1988 SIGMA F AND D DIV LTD D (-) PENICILLAMINE
7691 I II 9/26/1988 CHEMWERTH INC PROPANTHELINE BROMIDE
7692 I III 9/23/1988 REXAM CLOSURE SYSTEMS INC CONTAINER/CLOSURE SYSTEMS
7693 I IV 9/23/1988 B BRAUN MEDICAL INC STERILIZATION OF GLASS
7694 A II 9/30/1988 AJINOMOTO CO INC 2'3'-DIDEOXYINOSINE
7695 I II 9/29/1988 PHARMECO LABORATORIES INC DTPA BIS (METHYLAMIDE) AND ITS SALTS
7696 I IV 9/29/1988 DS INDUSTRIE APS ESTARAM'S INA DRUG INGREDIENTS
7697 I II 9/29/1988 ESTEVE QUIMICA SA PIROXICAM
7698 I II 9/29/1988 TEIKOKU CHEM INDUSTRY THYMIDINE
7699 I II 10/3/1988 DIOSYNTH BV PRAZEPAM
7700 I II 10/1/1988 APPLIED LABORATORIES INC BLAIREX BRONCHO SALINE
7701 I II 10/5/1988 STOLLE RESEARCH AND DEVELOPMENT TETRACYCLINE BIODEGRADABLE
CORP MICROSPHERES
7702 I II 10/11/1988 BEIERSDORF GMBH MOXONIDINE
7703 I II 10/4/1988 ORION CORP LTD PENTOXIFYLLINE
Page 243
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7704 I II 10/12/1988 VICTREX USA INC POLYETHERETHERKETONE (PEEK)
7705 A IV 9/30/1988 IOI OLEO GMBH SOFTIGEN 767 EXCIPIENTS
7706 I I 10/13/1988 CYGNUS RESEARCH CORP FACILITIES AND G. SITE UTILIZED IN REDWOOD
CITY, CA
7707 I II 10/12/1988 INDUSTRIAS QUIMICAS TAUBATE SA ISOSORBIDE DINITRATE
7708 I I 10/11/1988 WHITEHALL LABS DIV AMERICAN HOME FACILITY LOCATED IN GUAYAMA, PUERTO RICO
PRODS CORP
7709 I II 10/13/1988 LINNEA PHYTOCHEMICALS PILOCARPINE NITRATE
7710 A II 10/13/1988 CAMBREX PROFARMACO MILANO SRL GLIPIZIDE
7711 I II 10/7/1988 MITSUBISHI KASEI CORP REPIRINAST (MY-5116) DRUG SUBSTANCE,
KASHIMA-GUN, JAPAN
7712 I II 10/12/1988 RP SCHERER NORTH AMERICA DIV RP NIFEDIPINE SOFTGELS 20 MG
SCHERER CORP
7713 I II 10/12/1988 RP SCHERER NORTH AMERICA DIV RP NIFEDIPINE SOFTGELS 10 MG
SCHERER CORP
7714 I II 10/11/1988 WAITAKI INTERNATIONAL BIOSCIENCES FACILITIES UTILIZED IN TORONTO, ONTARIO,
SUB WAITAKI CANADA LTD CANADA
7715 I III 10/7/1988 TEKNI-PLEX INC PVC COMPOUNDS
7716 I II 10/18/1988 ROUSSELL UCLAF BETAMETHASONE ACETATE
7717 I II 10/18/1988 CIPLA LTD METAPROTERENOL SULFATE
7718 I II 10/17/1988 SANOFI CHIMIE FACILITIES LOCATED IN SISTERON, FRNACE
7719 I II 10/17/1988 FRANCIS SPA CROMOLYN SODIUM
7720 I II 10/17/1988 RP SCHERER CORP MAXEPA OIL
7721 I II 10/20/1988 FABBRICA ITALIANA SINTETICI SPA TRIMETHOBENZAMIDE HYDROCHLORIDE
7722 I II 10/20/1988 SUMIKA FINE CHEMICALS CO LTD PRAZOSIN HYDROCHLORIDE (POLYHYDRATE)
7723 I IV 10/27/1988 AIR PRODUCTS AND CHEMICALS INC PERFLUOROPERHYDROPHENANTHRENE
EXCIPIENT
7724 I II 10/25/1988 RESOLUTION CHEMICALS LTD BACLOFEN RAW MATERIAL
7725 I III 10/21/1988 LOPAREX INC 10420, 3 MIL CL PET 4N/000
7726 I II 10/6/1988 SIMS AMILORIDE HCL
7727 I III 10/13/1988 MEDICAL MOLDING CORP AMERICA PLASTIC MATERIALS AND COLORANTS
7728 A II 10/25/1988 PHARMA-WALDHOF GMBH ADENOSINE
7729 I III 10/28/1988 NATIONAL LABEL CO NONPARENTERAL METAL PCAKAGING
7730 I III 10/18/1988 EXXONMOBIL CHEMICAL CO SANTOPRENE THERMOPLASTIC RUBBER 180 &
280 GRADE SERIES
7731 I I 9/1/1988 FERROSAN A/S FACILITES AND GENERAL OPERATING
PROCEDURES IN SOEBORG, DENMARK
7732 I IV 10/31/1988 CAPSULE TECHNOLOGY PUERTO RICO EMPTY HARD GELATIN CAPSULES
INC
7733 I IV 10/27/1988 DS INDUSTRIE APS ESTARAM 299
7734 I II 10/31/1988 DSM NUTRITIONAL PRODUCTS LTD TRETINOIN (ALL-TRANS-RETINDE, ACID)
7735 I III 10/11/1988 SCHUBERT SEALS AS RUBBER SHEET LAMINATE FROM COMPOUND
6377
7736 I III 10/11/1988 SCHUBERT SEALS AS RUBBER SHEET LAMINATE FROM COMPOUND
6377/42022 IN DENMARK
Page 244
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7737 I II 10/21/1988 GIVAUDAN CORP FACILITIES AND PROCEDURES IN VERNIER,
SWITZERLAND
7738 I II 10/21/1988 GIVAUDAN CORP PARSOL MCX
7739 I II 10/18/1988 AMINO GMBH BETAINE HCl
7740 I II 11/1/1988 NOVARTIS MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN GRIMSBY, UK
7741 I II 11/1/1988 RP SCHERER NORTH AMERICA DIV RP NIFEDIPINE SOFTGELS 10 MG, TO SUPPORT
SCHERER CORP CHELSEA LABS. ANDA
7742 I II 11/1/1988 RP SCHERER NORTH AMERICA DIV RP NIFEDIPINE SOFTGELS 20 MG, TO SUPPORT
SCHERER CORP CHELSEA LABS. ANDA
7743 I I 11/3/1988 SIGNA SA G. SITE, FACILITIES AND PERSONNEL UTILIZED
IN TOLUCA, MEXICO
7744 I II 10/25/1988 FREEDOM CHEMICAL DIAMALT GMBH CARBAMAZEPINE
7745 I II 10/31/1988 PENINSULA LABS INC BETA-ENDORPHIN
7746 I II 11/8/1988 PHARMACIA AND UPJOHN NICOTINE TRANSDERMAL DELIVERY SYSTEM
7747 I IV 11/9/1988 DS INDUSTRIE APS Z-ESTARAM
7748 I II 10/25/1988 KOREA STEEL CHEMICAL CO LTD YELLOW PHENOLPHTHALEIN
7749 I II 11/8/1988 EASTMAN KODAK CO RHODAMINE 123
7750 I II 10/28/1988 SOL PHARMACEUTICALS LTD ALBUTEROL SULPHATE
7751 I II 11/4/1988 GOODWIN INST MANUFACTURING SITE, FACILITES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PLATATION, FLORIDA.
7752 I II 11/7/1988 RP SCHERER NORTH AMERICA DIV RP NIFEDIPINE SOFTGELS 20 MG, KALIPHARMA,
SCHERER CORP INC.
7753 I II 11/15/1988 CELLTEC LABS LTD FACILITIES UTILIZED IN MADRAS, INDIA
7754 I II 11/7/1988 RP SCHERER NORTH AMERICA DIV RP NIFEDIPINE SOFTGELS 10 MG
SCHERER CORP
7755 I II 11/14/1988 SIEGFRIED AG DIBENZOSUBERENONE
7756 I II 10/28/1988 PCAS DILTIAZEM HYDROCHLORIDE
7757 A IV 11/9/1988 LUBRIZOL ADVANCED MATERIALS INC CARBOPOLS 1342 AND 1382 AND PEMULEN
BASE TR-1 AND TR-1
7758 I III 11/4/1988 AUTOMATIC INJECTION MOLDING INC PACKAGING MATERIALS
7759 I II 10/28/1988 FERMION OY CYCLOBENZAPRINE HCL
7760 A III 10/5/1984 DUPONT TEIJIN FILMS US LP POLYESTER FILMS
7761 I II 11/22/1988 SUMIKA FINE CHEMICALS CO LTD PROBUCOL
7762 I II 11/21/1988 SUMIKA FINE CHEMICALS CO LTD PRAZOSIN HCL (BETA-FORM)
7763 I II 11/15/1988 HARTINGTON CHEMICALS DIV ACETAMINOPHEN DC-PGS
STAVELEY CHEMICALS LTD
7764 I II 11/22/1988 FRANCIS SPA GEIBROZIL
7765 I IV 11/18/1988 HERCULES INC HERCULES RS, AS AND SS NITROCELLULOSE
7766 A II 11/18/1988 SIEGFRIED LTD NICOTINE
7767 I III 11/17/1988 GLASS CORP AMERICA AMPULES
Page 245
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7768 I II 11/16/1988 PRODUITS ROCHE SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN FONTENAY-SOUS-BOIS,
FRANCE.
7769 I II 11/16/1988 ROCHE PRODUCTS INC FACILITIES UTILIZED IN DALRY, SCOTLAND
7770 I II 11/21/1988 LINNEA PHYTOCHEMICALS CYTARBINE
7771 I II 11/8/1988 SIGMA F AND D DIV LTD A-KETOISOCAPROIC ACID, SODIUM SALT
7772 I III 11/21/1988 FRESENIUS USA INC PACKAGING OF SVP AND LVP PRODUCTS IN
OGDEN, UTAH
7773 I II 10/31/1988 IAF BIOCHEM INTERNATIONAL INC SYNTHETIC GLUCAGON HYDROCHLORIDE
"HUMAN"
7774 A IV 11/15/1988 CAPSUGEL INC GELATIN CAPSULES
7775 I IV 11/16/1988 NIPPON FINE CHEMICAL CO LTD PHOSPHOLIPID DPPC
7776 I II 11/4/1988 REXOLIN CHEMS AB PIPERAZINE ADIPATE
7777 I II 11/18/1988 MEDEA RESEARCH LABORATORIES INC POLYTHIAZIDE
7778 I II 11/16/1988 SIEGFRIED USA INC OMOCONAZOLE NITRATE
7779 I II 11/4/1988 NATL INST HLTH ADAMHA DOC OMEGA-3 FATTY ACID ETHYL ESTERS
SUBMITTED FOR FOTMAC
7780 I III 10/31/1988 REXHAM CORP PACKAGING MATERIALS
7781 I II 11/21/1988 RAYLO CHEMICALS FACILITY AND PROCEDURES FOR GAMMA RAY
STERILIZATION
7782 I IV 11/17/1988 BASF CORP BUTOFAN NS 222
7783 I IV 11/17/1988 BASF CORP STYROFAN ND 487
7784 I I 11/25/1988 GRIFFITH MICRO SCI LTD FACILITIES LOCATED IN DERBYSHIRE, ENGLAND
Page 249
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
7900 I III 1/20/1989 MEGAS MANUFACTURING INC FACILITIES FOR PACKAGING IN CLEVELAND,
OHIO
7901 A II 1/26/1989 3M PURIFICATION INC ZETAPOR™ NYLON MEMBRANE CARTRIDGE
PRODUCTS: LIFEASSURE PSA SERIES,
LIFEASSURE BLA SERIES, LIFEASSURE PLA
SERIES, LIFEASSURE 020S4, 045SP, 020SP, AND
020ST SERIES, AND LIFEASSURE MEMBRANE
DISC PRODUCTS
Page 254
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8057 I II 5/11/1989 VALEAS SPA PHARMACEUKTICALS BRONCOVALEAS INHALER (ALBUTEROL
INHALER)
8058 I III 3/21/1989 PHE PHARMA ELASTOMERE GMBH CO RUBBER FORMULATIONS
KG
8059 I IV 4/25/1989 SIMETRY COMPANY HYDROPHOBIC CARRIER FOR CONTROLLED
RELEASE DOSAGE FORMS
8060 A II 5/6/1989 CIPLA LTD ALPRAZOLAM USP
8061 I II 4/24/1989 ANAQUEST INC FACILITIES, PERSONNEL AND OPERATING
PROCEDURES IN GUAYAMA, PR
8062 A II 5/6/1989 CIPLA LTD TERBUTALINE SULFATE USP
8063 I II 4/28/1989 JANSSEN PHARMACEUTICA NV CLAZURIL - R 62690
8064 I II 5/5/1989 MALLINCKRODT INC THE SODIUM IODIDE I-123
PHARMACEUTICALS BUSINESS OF
COVIDIEN
8065 I II 4/28/1989 SUMIKA FINE CHEMICALS CO LTD CYCLOBENZAPRINE HYDROCHLORIDE
8066 I II 5/16/1989 FUJISAWA PHARMACEUTICAL CO LTD FK366 ALDOSE REDUCTASE INHIBITOR
8067 I III 5/9/1989 GRAHAM PACKAGING CO LP CONTAINER/CLOSURE SYSTEMS
8068 I IV 5/9/1989 TAKASAGO INTERNATIONAL CORP TAK 80128 NATURAL ORANGE FLAVOR
8069 I II 5/26/1989 SAFEPHARM LABORATORIES LTD FACILITIES LOCATED IN SHARDLOW, ENGLAND
8070 A II 5/9/1989 PHARMAZELL GMBH 5-AMINOSALICYLIC ACID
(MESALAZINE/MESALAMINE)
8071 I II 5/10/1989 ABBOTT LABORATORIES CHEMICAL AND BRADYKININ ACETATE NPC-567
AGRICULTURAL PRODUCTS DIV
8072 I IV 8/17/1988 UNILEVER UNITED STATES INC DURKEE 07 EXCIPIENT
8073 I II 5/15/1989 ERBA BIOCHIMICA SPA FACILITIES LOCATED IN MILANO, ITALY
8074 I II 5/11/1989 MALLINCKRODT CHEMICAL INC FENTANYL ALKALOID
8075 I II 5/18/1989 SEPRACOR INC S-(+)- IBUPROFEN
8076 I II 4/18/1989 FARMABOIS BECLOMETHASONE DIPROPIONATE
8077 I II 5/15/1989 GANTAX NV PHARMACEUTICA PANCRUONIUM BROMIDE
8078 I II 5/17/1989 PENICK CORP MEPERIDINE HYDROCHLORIDE
8079 I IV 5/30/1989 AVANTI POLAR LIPIDS INC 1-STEAROYL-SN-GLYCERO-3-
PHOSPHOCHOLINE (PTDCHO-MONO180)
8080 I II 5/17/1989 WHEATON APPLICATOR CO FACILITIES LOCATED IN MILLVILLE, NJ
8081 I II 5/11/1989 WACKER CHEMIE GMBH PHTALIMIDOACETONE
8082 I IV 5/19/1989 B BRAUN MEDICAL INC STERILIZATION, SOLUTION PRODUCTS
8083 I III 5/24/1989 AIR PRODUCTS AND CHEMICALS INC FLEXCRYL 1653 EMULSION
8084 A III 5/23/1989 ABBOTT BIOLOGICALS BV PREFILLED BD READYFILL SYRINGE
8085 I II 5/26/1989 TRANS CONTAINER CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN UPLAND, CALIFORNIA.
8086 I II 5/16/1989 ABBOTT LABORATORIES LTD FACILITIES LOCATED IN QUEENBOROUGH,
KENT, UK
8087 I II 5/8/1989 KM LEE LABORATORIES INC G. SITE AND FACILITIES LOCATED IN SANTA FE
SPRINGS, CA
Page 255
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8088 I II 5/19/1989 DOW CORNING CORP BIO-RELEASE SILICONE RELEASE COATING
SYSTEM, HEMLOCK, MI
8090 I III 5/24/1989 AIR PRODUCTS AND CHEMICALS INC FLEXCRYL 1614 EMULSION
8091 I II 6/1/1989 CAMBREX PROFARMACO MILANO SRL AMOXAPINE
8092 I II 6/1/1989 ROCHE PALO ALTO LLC TICLOPIDINE HCL- BOULDER, CO, SPRINGFIELD,
MO, EVIONNAZ,SWITZ
8093 I II 6/7/1989 DIOSYNTH BV DESMOPRESSIN
8094 A III 6/1/1989 UACJ FOIL CORP PACKAGING MATERIALS
8095 I II 6/7/1989 SIBEFAT SPA MICONAZOLE NITRATE
8096 I II 4/25/1989 CESQUISA SA CLOBETASOL PROPIONATE
8097 I II 6/8/1989 HOECHST MARION ROUSSEL SA VINORELBINE DITARTRATE
8098 I V 5/30/1989 BRISTOL MYERS PRODUCTS DIV STERILE PROCESSING FACILITY IN JAPAN
BRISTOL MYERS CO
8099 I II 6/13/1989 ZENECA INC SDM 70
8100 I II 4/27/1989 RESEARCH BIOCHMICALS INC (HIPDM)
8101 I II 6/8/1989 CILAG AG CYCLOBENZAPRINE HCL
8102 I III 5/31/1989 SCHUBERT SEALS AS 7.2 MM PLUNGER
8103 I III 5/31/1989 SCHUBERT SEALS AS RUBBER SHEET LAMINATE FOR DISCS
8104 I III 6/2/1989 GERRESHEIMER BUNDE GMBH STAKED NEEDLE DISPOSABLE SYRINGE
8105 I II 6/16/1989 HAYDEN MANUFACTURING CO INC FACILITIES FORHAYDEN MOLDING LTD. IN
BRANTFOR, ONTARIO, CANADA
8106 I II 6/12/1989 BOEHRINGER MANNHEIM GMBH CATALASE THERAPEUTIC GRADE
8107 I II 6/15/1989 CUNO INC ZETA PLUS LA MEDIA AND CARTRIDGES IN
STAFFORD SPRINGS, CT
8108 I II 6/15/1989 CUNO INC ZETA PLUS SA MEDIA AND CARTRIDGES IN
STAFFORD SPRINGS, CT
8109 I II 6/15/1989 BAYER AG AMPICILLIN SODIUM STERILE
8110 I II 6/23/1989 UNILEVER UNITED STATES INC DURKOTE CALCIUM CARBONATE 1551-95 (P),
JOLIET & CHICHAGO, IL
8111 I II 6/26/1989 CUNO INC ZETA PLUS CA MEDIA AND CARTRIDGES
8112 A II 6/20/1989 ASPEN OSS BV RIMEXOLONE
8113 I III 6/22/1989 BAXTER HEALTHCARE CORP PRODUCTION OF TERMINALLY STERILIZED
PARENTERAL SOLUTIONS IN IL. AND MS.
8114 I IV 6/28/1989 JM HUBER CORP AMORPHOUS PRECIPITATED SILICON DIOXIDE
8115 I II 6/20/1989 HEUMANN PCS GMBH CYCLOBENZAPRINE-HCL
8116 A II 6/26/1989 SANOFI AVENTIS DEUTSCHLAND GMBH LEFLUNOMIDE
8117 I II 6/26/1989 LUSOCHIMICA SPA TERBUTALINE SULPHATE
8118 I II 7/15/1989 DIOSYNTH BV HUMAN MENOPAUSAL GONADOTROPHIN
NATURAL - OSS, THE NETHERLANDS
8119 I II 6/28/1989 OCCIDENTAL CHEM CORP ETHYLENE DICHLORIDE
8120 I II 7/7/1989 CIPLA LTD PROPANOLOL HCl
8121 I II 6/13/1989 HEUMANN PCS GMBH DICLOFENAC SODIUM
8122 I II 7/6/1989 TEKKOTE CORP FACILITIES LOCATED IN MOONACHIE, NJ
8123 I II 7/6/1989 BOREALIS AB FACILITIES LOCATED IN STENUNGSUND,
SWEDEN
Page 256
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8124 A III 7/19/1989 BOREALIS AG BORMED LE6607-PH
8125 I II 7/3/1989 NPBI BV FACILITIES LOCATED IN EMMEN, THE
NETHERLANDS
8126 I II 7/3/1989 NPBI BV MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL
8127 I II 7/5/1989 DAITO CORP CARBIDOPA
8128 I II 7/10/1989 VALPHARMA SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN REPUBLIC SAN MARINO.
8129 A II 7/10/1989 CAMBREX PROFARMACO MILANO SRL METAPROTERENOL SULFATE
8130 I II 6/30/1989 AID PACK INC FACILITIES LOCATED IN GLOUCESTER,
MASSACHUSETTS
8131 A II 7/10/1989 JOHNSON AND JOHNSON CONSUMER NASAL NICOTINE SOLUTION (NNS)
INC MCNEIL CONSUMER HEALTHCARE
DIV
8132 I II 7/13/1989 EASTMAN KODAK CO a-(2-AMINO-3-p-BROMOBENZOYLPHENYL)
ACETIC ACID SODIUM SALT
8133 I II 7/14/1989 NOVO NORDISK AS SUBTILISIN A
8134 A II 7/14/1989 BAYER AG CIPROFLOXACIN HYDROCHLORIDE
8135 I II 7/12/1989 BIOCHEMIC GESELLSCHAFT MBH TDA
8136 I II 7/12/1989 BIOCHEMIC GESELLSCHAFT MBH TET-ACA
8137 I II 7/12/1989 GEMA SA CEFAZOLIN
8138 I II 6/30/1989 SYNTEX SA FACILITIES LOCATED IN MEXICO CITY, MEXICO
8139 I III 7/7/1989 AKROSIL RELEASE LINERS FOR MEDICAL PRODUCTS
8140 A II 7/7/1989 IWAKI SEIYAKU CO LTD PHENYLEPHRINE HCL
8141 I V 7/25/1989 BRISTOL MYERS SQUIBB CO FACILITIES FOR PARENTERAL MANUFACTURING
(BUILDING 115) LOCATED IN NEW BRUNSWICK,
NJ
8142 I II 7/26/1989 NEWPORT PHARMACEUTICALS METOPROLOL TARTRATE
IRELAND
8143 I II 7/26/1989 SELOC AG NORTRIPTYLINE HCL
8144 I II 7/26/1989 WARNER LAMBERT CO MECLOFENAMATE SODIUM
8145 I IV 7/26/1989 INNOPHOS INC DIBASIC CALCIUM PHOSPHATE, ANHYDROUS (A-
TAB AND ANHYDROUS EMCOMPRESS)
8146 A III 7/19/1989 SANNER GMBH PACKAGING MATERIALS
8147 I II 7/20/1989 SIGMA F AND D DIV LTD N,N-DIMETHYLTRYPTAMINE
8148 I III 7/31/1989 EXXONMOBIL CHEMICAL CO SANTOPRENE THERMOPLASTIC RUBBER
GRADE 171-55-W199
8149 I III 7/11/1989 STYROLUTION EUROPE GMBH LURAN 358 N
8150 I IV 7/26/1989 HENRY H OTTENS MANUFACTURING CO NATURAL & ARTIFICIAL CHERRY MINT #5095-A
INC
8151 I II 7/25/1989 RECORDATI INDUSTRIA CHIMICA E GALLOPAMIL HCL
FARMACEUTICA SPA
8152 I II 8/1/1989 SOGO PHARMACEUTICAL CO LTD SULFADIMETHOXINE
8153 I II 7/27/1989 CIMA LABORATORIES INC FACILITIES LOCATED IN MINNEAPOLIS, MN
Page 257
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8154 I III 7/31/1989 SCHUBERT SEALS AS RUBBER COMPOUND 6404
8155 I III 7/31/1989 SCHUBERT SEALS AS RUBBER COMPOUND 41003
8156 I III 7/31/1989 SCHUBERT SEALS AS RUBBER COMPOUND 42038
8157 I III 7/31/1989 SCHUBERT SEALS AS RUBBER COMPOUND 42022
8158 I III 7/31/1989 SCHUBERT SEALS AS RUBBER COMPOUND 41002, HORSENS,
DENMARK
8159 I III 7/31/1989 SCHUBERT SEALS AS PTFE FILM
8160 I II 8/8/1989 ABBOTT LABORATORIES CHEMICAL AND GADOLINIUM
AGRICULTURAL PRODUCTS DIV DIETHYLENETRIAMINEPENTAACETIC ACID, N.
CHICAGO, IL
8161 I II 8/2/1989 DELMAR CHEMICALS INC AMIODARONE HCL
8162 I IV 7/27/1989 SEPRACOR INC DEAE SPHERODEX M/LS
8163 I II 8/2/1989 CAMBREX PROFARMACO MILANO SRL DIFLUNISAL
8164 A II 8/2/1989 CAMBREX PROFARMACO MILANO SRL CROMOLYN SODIUM / SODIUM CROMOGLICATE
8165 I III 8/10/1989 PHARMASCIENCE INC HIMEDICS DISPENSER
8166 I II 8/15/1989 BRISTOL MYERS CO INTERNATIONAL FACILITIES LOCATED IN MAYAGUEZ, PUERTO
DIV RICO
8167 I II 8/15/1989 RHONE POULENC RORER LINDANE
PHARMACEUTICALS INC
8168 I II 7/25/1989 IRONWOOD INDUSTRIES FACILITIES LOCATED IN LIBERTYVILLE, IL
8169 A III 8/7/1989 LOPAREX LLC FILM BASED 4000E COATED RELEASE LINERS
8170 I III 8/9/1989 HAZEN PAPER CO DRUG PACK H-130
8171 A II 8/9/1989 SIEGFRIED EVIONNAZ SA CINCHOCAINE BASE AND HCL
8172 I II 8/11/1989 PHARM ECO LABORATORIES INC PENTAMIDINE ISETHIONATE
8173 I IV 8/17/1989 IMAJE INK JET PRINTING CO ED-1112-H2 BLUE INK
8174 I III 8/18/1989 DOW DERMATOLOGICS INC VOID
8175 I II 7/19/1989 PHARMECO LABORATORIES INC DIPIVEFRIN HCL
8176 I II 8/15/1989 ABBOTT LABORATORIES PENTAMIDINE ISETHIONATE
8177 I II 8/30/1989 DELMAR CHEMICALS INC FAMOTIDINE
8178 A II 8/15/1989 BAYER AG IOPROMIDE
8179 I II 8/18/1989 LUMELITE PLASTICS FACILITIES AND PERSONNEL LOCATED IN
PAWLING, NY
8180 I II 8/21/1989 NATL INST HLTH CONTRACEPTIVE DEV ANTIDE
BRANCH
8181 I III 8/24/1989 EI DUPONT DE NEMOURS AND CO INC TEFLON FEP FLUROCARBON RESINS, S 100,
140, 160
8182 I IV 8/22/1989 AVATAR CORP LIGHT MINERAL OIL NF
8183 I II 8/24/1989 A POTASSIUM NITRATE
8184 I II 8/28/1989 NANTONG PHARMACEUTICAL FACTORY PIROXICAM
8185 I II 8/25/1989 SUMIKA FINE CHEMICALS CO LTD METHOTREXATE
8186 I IV 8/18/1989 A FLAVOR POTENTIATOR #3096-E
8187 I II 8/9/1989 FINE CHEMICALS CORP GUANABENZ ACETATE
8188 I II 8/25/1989 CREATIVE BIOMOLECULES EPIDERMAL GROWTH FACTOR-51
8189 I II 8/28/1989 EGIS PHARMACEUTICALS PRIVATE LTD CARBIDOPA
Page 258
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8190 I I 8/31/1989 GRUPPO LEPETIT SPA FACILITIES LOCATED IN GARESSIO (CUNEO)
ITALY
8191 A II 8/10/1989 KOEI CHEMICAL CO LTD PYRMETHYL ALCOHOL
8192 A II 8/28/1989 CHENG FONG CHEMICAL CO LTD DICLOFENAC SODIUM
8193 I II 9/7/1989 HIMEDICS INC R&D PLANT 1 LOCATED IN HOLLYWOOD, FL
8194 I I 9/8/1989 CG SMITH CHEMICALS DIV CG SMITH FACILITIES LOCATED IN DURBAN, SOUTH
SUGAR LTD AFRICA
8195 A II 9/8/1989 RELAX LTD LACTULOSE CONCENTRATE USP
8196 I II 9/5/1989 MEIJI SEIKA KAISHA LTD PIRARUBICIN BASE
8197 I II 9/5/1989 MEIJI SEIKA KAISHA LTD PIRARUBICIN HCl FOR INJECTION
8198 I II 9/5/1989 MEIJI SEIKA KAISHA LTD ODAWARA PLANT LOCATED IN KANAGAWA,
JAPAN
8199 I II 9/11/1989 SEITZ FILTER WERKE MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BAD KREUZNACH, FRG.
8200 I II 9/8/1989 DSM PHARMA CHEMICALS SOUTH KETOPROFEN
HAVEN INC
8201 I III 5/3/1989 CLEARPLASS CONTAINER INC PLASTIC CONTAINERS
8202 I II 9/1/1989 YUKI GOSEI KOGYO CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF 2-DEOXYCYTIDINE
HYDROCHLORIDE IN TOKYO, JAPAN.
8203 I II 9/7/1989 CHEMI SPA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PATRICA (FROSINONE)ITALY.
8204 I II 8/11/1989 A CHLORTHALIDONE
8205 A II 9/6/1989 QUIMICA SINTETICA SA MICONAZOLE NITRATE
8206 I II 9/6/1989 QUIMICA SINTETICA SA LOPERAMIDE HCL
8207 I I 9/8/1989 UNISYN TECHNOLOGIES CORP FACILITIES LOCATED IN TUSTIN, CA
8208 I II 9/15/1989 RALLIS INDIA LTD CROMOLYN SODIUM
8209 I III 9/15/1989 ASAHI CHEMICAL INDUSTRY CO LTD BARRIALON UB-6
8210 I II 9/18/1989 SUMITOMO CHEMICAL CO LTD SM-8668
8211 I II 9/1/1989 EURAND AMERICA INC MICROENCAPSULATED SULFAMETHOXAZOLE
8212 I II 9/19/1989 SMITH AND NEPHEW RES LTD APRACLONIDINE HCl
8213 I I 9/19/1989 SMITH AND NEPHEW RES LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN HARLOW, ESSEX, UNITED
KINGDOM.
8214 I II 9/19/1989 SMITH AND NEPHEW MANUFACTURING SITE, FACILITIES,
PHARMACEUTICALS LTD PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ROORD, ESSEX, UNITED
KINGDOM
8215 I II 9/20/1989 RHONE POULENC INSTITUTE DE UREA-CALCIUM ACETYLSALICYLATE, VITRY SUR
BIOPHARMACIE SEINE CEDEX, FRANCE
8216 I II 9/19/1989 GANES CHEMICALS INC PENNSVILLE NORTRIPTYLINE CARBAMATE
Page 259
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8217 I I 9/19/1989 NORTHVIEW LABS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN NORTHBROOK, ILLINOIS.
8218 A II 8/18/1989 ELANCO ANIMAL HEALTH DICLAZURIL
8219 A II 9/7/1989 FDC LTD FLURBIPROFEN USP
8220 A III 9/18/1989 LOPAREX LLC 11117, S 72# BL KFT L/L 4D/000
8221 A II 9/21/1989 ALBEMARLE CORP TETRACAINE HCL
8222 I II 9/20/1989 TOMITA PHARMACEUTICAL CO LTD ALUMINUM HYDROXIDE GEL
8223 I III 9/25/1989 BETTS MEXICO SA DE CV PACKAGING MATERIALS
8224 I II 9/26/1989 NP INDUSTRIES INC FACILITIES LOCATED IN ST. LOUIS, MO
8225 A II 9/21/1989 ROCHE DIAGNOSTICS GMBH ADENOSINE DEAMINASE THERAPEUTIC GRADE
8226 I II 9/29/1989 SUMITOMO CHEMICAL CO LTD TIMOLOL MALEATE
8227 I II 9/26/1989 HAMPSHIRE CHEMICAL CORP FACILITIES LOCATED IN DEER PARK, TEXAS
8228 I II 9/26/1989 ICI COLOURS AND FINE CHEMS THIOTEPA
8229 I III 9/18/1989 ADVANCED ELASTOMER SYSTEMS TREFSIN THERMOPLASTIC RUBBER
8230 I II 9/25/1989 AVATAR CORP PROPYLENE GLYCOL
8231 I II 10/3/1989 MEDICHEM SA PIROXICAM
8232 I II 9/29/1989 DISCOVERY THERAPEUTICS INC N-0923
8233 I V 9/29/1989 DISCOVERY THERAPEUTICS INC PHARMACOLOGY & TOXICOLOGY DATA ON N-
0923
8234 A II 10/1/1989 OLON SPA CROMOLYN SODIUM
8235 I II 10/5/1989 IAF BIOCHEM INTERNATIONAL INC CALCITONIN
8236 I I 9/29/1989 KNOLL PHARMACEUTICAL CO FACILITIES FOR THE G. OF CHYMODIACTIN
8237 I II 10/3/1989 KANEGAFUCHI CHEMICAL INDUSTRY CO FACILITIES LOCATED IN TAKASAGO CITY,
LTD HYOGO PREFECTURE, JAPAN
8238 I II 10/5/1989 ERREGIERRE SPA TERFENADINE
8239 I II 10/5/1989 ROUSSELL UCLAF NORETHINDRONE
8240 I II 10/4/1989 IVERS LEE LTD FACILITIES LOCATED IN BRAMPTON, ONTARIO,
CANADA
8241 I II 10/6/1989 ASH STEVENS INC FLUDARABINE PHOSPHATE
8242 I I 9/12/1989 FINE GRINDING CORP FACILITIES LOCATED IN CONSHOHOCKEN,
PENNSYLVANIA
8243 A II 10/11/1989 TAKEDA GMBH PANTOPRAZOLE SODIUM SESQUIHYDRATE
8244 I II 10/12/1989 BYK GULDEN LOMBERG CHEMISCHE FACILITIES LOCATED IN SINGEN AND
FABRIK GMBH KONSTANZ, WEST GERMANY
8245 I I 10/10/1989 GREENWICH PHARMACEUTICALS INC FACILITIES LOCATED IN HORSHAM,
PENNSYLVANIA
8246 A III 10/16/1989 MITSUBISHI CHEMICAL CORP VINYFOIL RIGID PVC CALENDERED FILM
8247 I I 10/17/1989 DSM PHARMA CHEMICALS 3-T-BUTYLAMINO-1,2-PROPANEDIOL
NETHERLANDS BV
8248 A III 10/12/1989 CKS PACKAGING INC EXTRUSION BLOWN PLASTIC BOTTLES
8249 I II 10/12/1989 SMITH KLINE CONSUMER PRODUCTS BANDING OF PSEUDOEPHEDRINE HCl AND
CHLORPHENIRAMINE MALEATE
8250 I IV 10/11/1989 HENRY H OTTENS MANUFACTURING CO NATURAL/ARTIFICIAL CHERRY MINT FLAVOR
INC #5073A - PHILA., PA.
Page 260
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8251 I III 10/9/1989 GRAFCO PET PLASTIC CONTAINERS
8252 I IV 10/3/1989 SEPRACOR INC QMA SPHEROSIL M/LS
8253 I II 10/19/1989 BACHEM FINE CHEMICALS INC GLUCAGON (1-29), HUMAN HCl SALT -
TORRANCE AND SAN DIEGO, CA.
8254 I II 10/20/1989 BAYER AG FACILITY AND OPERATING PROCEDURES IN
DORMAGEN, WEST GERMANY
8255 I II 10/17/1989 PROFARMACO SRL ETHYL ESTER 3-(2-CHLORO-4,5-
DIFLUOROPHENYL)-3-OXO PROPIONIC
8256 I II 10/17/1989 EASTMAN CHEMICAL CO MANUFACTURING SITE, FACILITIES,
PERSONNEL AND GENERAL OPERATING
PROCEDURES IN ROCHESTER, NEW YORK.
8257 A IV 10/12/1989 LIPOID GMBH LIPOID PG 18:0/18:0 (1,2-DISTEAROYL-SN-
GLYCERO-3-PHOSPHO-RAC-GLYCEROL, SODUM
SALT; DSPG-NA)
8258 I II 10/20/1989 WYCKOFF CHEMICAL CO INC PROBUCOL
8259 A II 10/17/1989 VERTELLUS INTEGRATED PYRIDINES NIACIN USP
LLC
8260 I III 10/16/1989 ANCHOR HOCKING PACKAGING CONTINUOUS THREAD METAL CLOSURES
8261 I II 10/12/1989 ARCHIMICA SPA 2-CHLORO-4.5-DIFLUOROPHENYL-B-
KETOESTER (SOL.) - VARESE,ITALY
8262 I II 10/12/1989 ARCHIMICA SPA 2-CHLORO-4.5-DIFLUOROPHENYL-B-
KETOESTER - VARESE, ITALY
8263 I II 10/27/1989 ANDRULIS PHARMACEUTICALS CORP THALIDOMIDE
8264 I II 11/22/1989 SIPSY SNC HYDROCORTISONE-17-BUTYRATE
8265 I II 10/27/1989 AMERSHAM CORP SODIUM IOTHALAMATE I-125 INJECTION
8266 I II 10/17/1989 RHONE-POULENC SANTE INC NICERGOLINE
8267 I II 10/25/1989 GRAIN PROCESSING CORP FACILITY FOR WATER LOCK(R)
SUPERABSORBENT POLYMERS IN IOWA
8268 I I 10/31/1989 TOKYO KASEI KOGYO CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN FUKAYA, JAPAN.
8269 I II 10/27/1989 TIANJIN PHARMACEUTICAL PLANT HYDROCORTISONE
8270 I II 10/31/1989 TOKYO KASEI KOGYO CO LTD 2,7-DIFLUORO-5-METHOXYSPIRO(9H-
FLUORENE-9,4'-IMIDAZOLIDINE
8271 I III 10/2/1989 CALIGEN FOAM LTD POLYESTER POLYURETHANE FOAM 5100A
8272 I II 10/24/1989 CHEMI SPA OXIRACETAM
8273 I I 10/27/1989 EISAI CO LTD FACILITY IN GIFU-KEN, JAPAN FOR THE G. OF
E3810 DRUG PRODUCT
8274 I I 10/27/1989 EISAI CO LTD FACILITY IN IBARAKI-KEN, JAPAN G. OF E3810
DRUG SUBSTANCE
8275 A III 10/26/1989 KEY INTERNATIONAL INC POLYETHYLENE FILM (ALUMINUM FOIL)
8276 I III 10/23/1989 SCHUBERT SEALS AS RUBBER COMPOUND 6374B2
8277 I II 10/31/1989 SUMIKA FINE CHEMICALS CO LTD MESORIDAZINE BESYLATE
8278 I II 10/3/1989 FREEDOM CHEMICAL DIAMALT GMBH 6-PROPYL-2-THIOURACIL
8279 I II 11/2/1989 ABBOTT PHARMACEUTICALS INC FENTANYL CITRATE
Page 261
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8280 I II 11/2/1989 AVATAR CORP WHITE MINERAL OIL
8281 I II 11/2/1989 MALLINCKRODT BAKER INC SODIUM FLUORIDE
8282 A II 10/24/1989 AMINO GMBH L-TRYPTOPHAN
8283 I II 11/6/1989 PENINSULA LABS INC HISTIDINYL-31-GLYCINE
8284 I II 11/10/1989 THERATECH INC FACILITY LOCATED IN SALT LAKE CITY, UTAH
8285 I II 11/15/1989 MEDICHEM SA KETOPROFEN
8286 I II 11/14/1989 ZAMBON SPA PROBUCOL USP
8287 I III 11/17/1989 SPA SAFTA POLYESTER, ALUMINUM FOIL , POLYETHYLENE
8288 A II 11/17/1989 UNION QUIMICO FARMACEUTICA SA RANITIDINE HCL
(UQUIFA SA)
8289 I I 11/17/1989 SIMIREX INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MT. LAUREL, NEW JERSEY.
8290 I II 11/15/1989 GUANGDONG PHARMACEUTICAL SULFADIAZINE AND SULFADIAZINE SODIUM
FACTORY
8291 I II 11/24/1989 MEDICHEM SA GUANABENZ ACETATE
8292 I II 11/16/1989 LEK PHARMACEUTICAL AND CHEMICAL AURANOFIN
CO DD
8293 I V 11/21/1989 DR MADAUS GMBH NON-PRODUCT SPECIFIC DOCUMENTATION
FOR STERILIZATION PROCESS VALIDATION
APPLICATIONS FOR HUMAN AND VETERINARY
DRUG PRODUCTS
8294 I II 11/16/1989 CHEMAPOL LTD SULFAMETHAZINE
8295 I II 11/10/1989 CHEMAPOL LTD SULFANILAMIDE
8296 A II 11/14/1989 TEVA PHARMACEUTICAL INDUSTRIES CARBIDOPA USP (DRUG SUBSTANCE)
LTD
8297 I II 11/13/1989 RECORDATI INDUSTRIA CHIMICA SPA MEBEVERINE HYDROCHLORIDE
8298 A II 11/17/1989 COOPERSURGICAL INC COPPER T MODEL TCU 380A INTRAUTERINE
CONTRACEPTIVE
8299 I III 11/27/1989 TICONA LLC RITEFLEX POLYESTER ELASTOMER
8300 I III 10/1/1989 ROSSENDALE COMBINING CO LTD POLYETHYLENE FILM FOAM LAMINATE
8301 I I 11/16/1989 GRIFFITH MICRO SCIENCE INC ETO STERILIZATION PROCESS IN
WILLOWBROOK, ILLINOIS
8302 I II 11/22/1989 SOUTHERN RESEARCH INSTITUTE FACILITY LOCATED IN BIRMINGHAM, ALABAMA
8303 A III 11/3/1989 HOFFMANN NEOPAC AG LAMINATE COLLAPSIBLE TUBING
8304 A II 11/24/1989 SIEGFRIED EVIONNAZ SA FELBAMATE
8305 I IV 11/17/1989 SEPRACOR INC SP-SPHERODEX M/LS
8306 I II 12/4/1989 SANOFI CHIMIE FACILITY LOCATED IN SISTERON, FRANCE
8307 I II 12/4/1989 BIOCHEMICAL FACTORY NANJING UNIV CHINESE CRUDE HMG
8308 I II 11/1/1989 LEO PHARMA AS CALCIPOTRIENE DRUG SUBSTANCE
8309 I II 11/10/1989 BOEHRINGER KNOLL LTD PROPRANOLOL HYDROCHLORIDE
8310 I II 11/27/1989 WHATMAN WHATMAN DE52 (DIETHYLAMINOETHYL
CELLULOSE)
8311 I II 11/27/1989 ORGAMOL SA PROPAFENONE HYDROCHLORIDE
8312 I II 11/27/1989 LEO PHARMA AS CALCIPOTRIENE OINTMENT
Page 262
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8313 I II 11/27/1989 LEO PHARMACEUTICAL PRODUCTS LTD FACILITIES AND OPERATING PROCEDURES IN
BALLERUP, DENMARK
8314 I II 12/1/1989 LANZ LABORATORIES LOPERAMIDE HYDROCHLORIDE
8315 I II 12/7/1989 XYROFIN AG FACILITIES AND OPERATING PROCEDURES
8316 I II 12/7/1989 XYROFIN AG XYLITOL
8317 I II 12/1/1989 FINE ORGANICS LTD N,N-DIMETHYLAMINOTHIOACETAMIDE
HYDROCHLORIDE
8318 I II 12/8/1989 FERMENTECH LTD PROTEIN A
8319 I II 12/11/1989 MITSUBISHI CHEMICAL CORP MCI-196 DRUG SUBSTANCE
8321 I IV 12/5/1989 CUNO INC ZETAFFINITY UNCOUPLED MEDIA
8322 I II 11/27/1989 LEO PHARMACEUTICAL PRODUCTS LTD FACILITIES AND OPERATING PROCEDURES
Page 263
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8346 I III 12/26/1989 SEITZ FILTER WERKE SUPRADISC (R) DEPTH FILTER MODULES, BAD
KREUZNACH, FRG
8347 I II 12/15/1989 NEPERA INC ESTROPIPATE
8348 I II 11/10/1989 NEORX INC RHENIUM RE 186
8349 I II 12/29/1989 PLIVA PHARMACEUTICAL CHEMICAL CHLORHEXIDINE BASE
FOOD & COSMETIC INDUSTRY
8350 I III 12/31/1989 ADVANCED MONOBLOC INC EIANLAKK IA-1001A
8351 I III 12/15/1989 AMPACET CORP 11147 CAMEL WHITE PEMB
8352 I II 11/19/1989 NOBEL CHEMS SPA KETOPROFEN
8353 I II 12/26/1989 SUMIKA FINE CHEMICALS CO LTD PIROXICAM
8354 A III 12/14/1989 AMPACET CORP 11078 WHITE PEMB
8355 I II 12/29/1989 BACHEM FEINCHEMIKALIEN AG THYMORALIN
8356 A III 12/20/1989 CELANESE EVA PERFORMANCE EVA COPOLYMERS AND LDPE RESINS
POLYMERS
8357 I II 8/21/1989 DIOSYNTH BV MIRTAZAPINE
8358 I I 12/22/1989 MERRELL DOW PHARMS CANADA INC FACILITIES AND OPERATING PROCEDURES IN
ONTARIO, CANADA
8359 I I 12/28/1989 TROPONWERKE GMBH CO KG MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
8360 I II 12/28/1989 WYETH-AYERST RESEARCH FACILITIES AND OPERATING PROCEDURES IN
QUEBEC, CANADA
8361 I II 12/27/1989 SQUIBB MARK DIV ER SQUIBB AND HYDROXYUREA LYOPHILIZED POWDER
SONS INC
8362 I III 11/13/1989 IRONWOOD INDUSTRIES JAYCAPS
8363 I II 12/18/1989 PLIVA PHARMACEUTICAL CHEMICAL CHLORHEXIDINE GLUCONATE SOLUTION
FOOD & COSMETIC INDUSTRY
8364 A II 12/29/1989 PHARMACOSMOS AS IRON DEXTRAN POWDER
8365 I II 3/28/1989 HYBRITECH INC YTTRIUM-90 CHLORIDE
8366 I II 12/21/1989 RISDON PHARMA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN DIEPPE, FRANCE.
8367 I II 12/22/1989 LABORATOIRE PEROUSE FACILITIES LOCATED IN RANTIGNY, FRANCE
STERILISATION
8368 I II 12/19/1989 VIATRIS GMBH AND CO KG AZELASTINE HCl
8369 I II 1/11/1990 QUIMICA SINTETICA SA TERFENADINE
8370 I II 1/11/1990 KNOLL PHARMA CHEMICALS FLOSEQUINAN
8371 A II 12/25/1989 TAISHO PHARMACEUTICAL CO LTD HYDROCORTISONE BUTEPRATE
8372 I II 11/22/1989 AZIENDE CHIMICHE RIUNITE ANGELINI ETOPERIDONE HYDROCHLORIDE
FRANCESCO SPA
8373 I II 1/11/1990 KYOWA HAKKO KOGYO CO LTD SODIUM HYALURONATE
8374 I I 1/15/1990 MEDISOL LABORATORIES INC FACILITIES LOCATED IN EAST HANOVER, NJ
8375 I II 1/16/1990 DAINIPPON PHARMACEUTICAL CO LTD AT-4140
8376 I III 1/26/1990 FERRO CORP THERMOPLASTIC COMPOUNDS
8377 I II 1/15/1990 ROCHE DIAGNOSTICS GMBH PROPYLTHIOURACIL
Page 264
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8378 I II 1/12/1990 SALK INST BIOLOGICAL STUDIES ANITIDE
8379 A II 1/19/1990 EVONIK NUTRITION AND CARE GMBH CHLORHEXIDINE DIGLUCONATE
8380 I II 1/22/1990 MALLINCKRODT INC SODIUM PERRHENATE RE 186 INJECTION,
MARYLAND HEIGHTS, MO
8381 A II 11/23/1989 OLON SPA PROTRIPTYLINE HYDROCHLORIDE
8382 I II 1/24/1990 MARION MERRELL DOW INC SUDAFED 12-HOUR CAPSULES
8383 I II 1/22/1990 STOLLE RESEARCH AND DEVELOPMENT 90 DAY PROGESTERONE
CORP
8384 I IV 1/23/1990 SEPPIC DIV AIR LIQUIDE SEPIFILM 752
8385 I IV 1/23/1990 SEPPIC DIV AIR LIQUIDE SEPIFILM 003
8386 I I 1/18/1990 CLINICAL PACKAGING SERVICES INC FACILITIES AND OPERATING PROCEDURES IN
WATERBURY, CT
8387 I II 1/23/1990 SHANGHAI NO 2 PHARMACEUTICAL SULFATHIAZOLE
FACTORY
8388 I II 1/22/1990 DSM PHARMA CHEMICALS SOUTH NORTRIPTYLINE HYDROCHLORIDE
HAVEN INC
8389 I II 1/18/1990 PFANSTIEHL LABORATORIES INC AURANOFIN
8390 I II 1/19/1990 THERAKOS INC UVADEX (METHOXSALEN), STERILE SOLUTION,
NUTLEY, NJ
8391 I II 1/25/1990 PAREKH CHEMICALS ITALIA SPA CEFADROXIL
8392 I II 1/25/1990 PAREKH CHEMICALS ITALIA SPA FACILITIES IN BORGO SAN GIOVANNI, MILAN,
ITALY
8393 I II 1/15/1990 ORGAMOL SA ESERINE BASE AND SALICYLATE
8394 A III 1/4/1990 AMPACET CORP 11585 WHITE PE MB
8395 I III 1/4/1990 AMPACET CORP 11560 WHITE
8396 A II 1/26/1990 POLYPEPTIDE LABORATORIES SWEDEN DESMOPRESSIN
AB
8397 I III 1/15/1990 VETREIA PARMENSE BROMIOLI ROCCO GLASS CONTAINERS
SPA
8398 I II 1/25/1990 CILAG AG TERFENADINE
8399 I III 1/26/1990 EXXEL CONTAINER LP PACKAGING MATERIALS
8400 I II 1/26/1990 INFAR INDIA LTD VINCRISTINE SULPHATE (USP)
8401 I II 1/26/1990 INFAR INDIA LTD FACILITIES AND OPERATING PROCEDURES
8402 I III 1/30/1990 ALFA CHEMICALS ITALIANA SRL NAPROXEN
8403 A IV 1/27/1990 NOF CORP DIPALMITOYL PHOSPHATIDYL CHOLINE (DPPC)
8404 I I 1/24/1990 KORSCH PROCESSING LABORATORIES FACILITIES AND OPERATING PROCEDURES
INC
8405 I II 1/25/1990 KYOWA HAKKO KOGYO CO LTD AICA-RIBOSIDE
8406 I II 1/30/1990 NANTONG GENERAL PHARMACEUTICAL PRIMIDONE USP XXII
FACTORY
8407 I I 2/2/1990 LABORATORIES PFIZER LIMITADA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SAO PAULO, BRAZIL.
8408 I II 1/29/1990 PLIVA CROATIA LTD FACILITY FOR AZITHROMICIN DIHYDRATE G. IN
ZAGREB, YUGOSLAVIA
Page 265
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8409 I II 1/11/1990 PYMAH CORP ATI DIV FACILITIES FOR G. STERILIZATION PROCESS
INDICATORS
8410 A III 2/6/1990 BASELL POLIOLEFINE ITALIA SRL PURELL PE 1840 H
8411 I III 9/17/1989 BASF AKTIENGESELLSCHAFT LUPOLEN 1810 H
8412 A III 9/17/1989 BASELL POLYOLEFINE ITALIA SRL PURELL PE 1810 E
8413 A III 9/17/1989 BASELL POLIOLEFINE ITALIA SRL PURELL PE 3020 D
8414 I IV 1/27/1990 NIPPON OIL AND FATS CO LTD DISTEAROYL PHOSPHATIDYL CHOLINE
8415 I II 2/6/1990 CIPLA LTD NORFLOXACIN
8416 I II 2/1/1990 SOUTHWEST SYNTHETIC KETOPROFEN USP XXII
PHARMACEUTICAL CO LTD
8417 I II 1/30/1990 QUIMICA SINTETICA SA CIMETIDINE USP XXII
8418 I II 1/31/1990 WYETH PHARMACEUTICALS INC FACILITIES AND OPERATING PROCEDURES IN
MUENSTER, WEST GERMANY
8419 I II 2/5/1990 ZAMBON SPA MANUFACTURINGS SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN VICENZA, ITALY.
8420 I IV 1/31/1990 PACO RESEARCH CORP GELATIN BASED OPTHALMIC VEHICLE
8421 I II 2/6/1990 HOECHST MARION ROUSSEL SA METOLAZONE
8422 I III 2/1/1990 KOA GLASS CO LTD PARENTERAL AND NON PARENTERAL FLINT
GLASS CONTAINERS
8423 I II 2/2/1990 SCHERING AG NOCLOPROST BETA-CYCLODEXTRIN
CLATHRATE
8424 I II 1/1/1990 SIGMA F AND D DIV LTD TRIOLEIN
8425 I II 2/6/1990 SIGMA F AND D DIV LTD ANTI-FUNGAL DRUGS
8426 I II 2/1/1990 NV ORGANON PIMOZIDE
8427 I II 1/31/1990 BACHEM FEINCHEMIKALIEN AG N-FMOC-L-LEUCINE
8428 I II 2/6/1990 ROCHE QUIMICOS E FARMACEUTICOS FACILITIES AND OPERATING PROCEDURES IN
SA SAO PAULO, BRAZIL
8429 I II 1/26/1990 FINORGA (-)-(R)-1,2,3,4,-TETRAHYDRO-6,7-DIMETHOXY-2-
METHYL-1-(3,4,5-TRIMETHOXYBENZYL)
ISOQUINOLINE 2,3-DI-O-BENZOYL-L-TARTRATE
8430 I II 2/6/1990 ESTEVE QUIMICA SA METOPROLOL TATRATE
8431 A II 2/6/1990 GUSMER ENTERPRISES INC PHARMACEUTICAL GRADE FILTER MEDIA
8432 A III 2/21/1990 JSR CORP SYNDIOTACTIC 1, 2 POLYBUTADIENE
8433 I II 2/14/1990 SANDOZ LTD PHARMACEUTICAL DIV PHENYLALANINE-METHYLAMINOCYCLOL HCL
CHEMICAL DEVELOPMENT
8434 I I 2/13/1990 GENSIA PHARMACEUTICAL INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN IRVINE, CALIFORNIA.
8435 A II 2/20/1990 QUIMICA SINTETICA SA BUMETANIDE
8436 I II 2/19/1990 ALFA WASSERMANN SPA NAPROXEN SODIUM
8437 I I 2/22/1990 PHARMAKAPSEL PRODUKTIONS GMBH FACILITIES AND OPERATING PROCEDURES
& CO. KG
8438 I II 2/5/1990 PURAC BIOCHEM BV CALCIUM GLUCONATE
Page 266
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8439 I II 2/21/1990 PENINSULA LABS INC C- PEPTIDE ( 31 AMINO ACIDS) CODE # 7309 LOT
# 020524
8440 A III 2/19/1990 LOPAREX LLC GRADE 10925 S 80# SB SCK 4400M/000 R
8441 I III 2/19/1990 LOPAREX INC 10625, S 44# NT KFT H/00 4D/000
8442 A III 2/19/1990 LOPAREX LLC 11430 S 92# BL KFT L/L 4000D/000
8443 I II 2/28/1990 SUMIKA FINE CHEMICALS CO LTD FLAVOXATE HYDROCHLORIDE
8444 I II 10/20/1989 PFC ITALIANA SRL DIV ALFA CHEMICALS LEVODOPA
ITALIANA
8445 I III 4/27/1990 DOW CORNING CORP SILASTIC MDF-0372 AND MDF-0373 MEDICAL
GRADE TUBING -JAPAN
8446 I II 2/26/1990 PENINSULA LABS INC SUBSTANCE P CODE #7451 LOT #020973
8447 I II 3/2/1990 RESOLUTION CHEMICALS LTD BUMETAMIDE USP
8448 I II 2/27/1990 BIOCHEMIC GESELLSCHAFT MBH AMPICILLIN ANHYDRATE
8449 I II 3/2/1990 ASAHI CHEMICAL INDUSTRY CO LTD PHOSPHATIDYLGLYCEROL
8450 I II 2/15/1990 DEGUSSA AG WERK RADEBEUL PROCEDURES FOR CHLORHEXIDINE
8451 I II 2/15/1990 DEGUSSA AG WERK RADEBEUL CHLORHEXIDINE
8452 I I 2/28/1990 MERCK SA INDUSTRIA QUIMICAS G. FACILITIES IN PARNAIBA-PD-BRAZIL
8453 I II 3/2/1990 ANIDRO DO BRASIL EXTRACOES SA PILOCARPINE HYDROCHLORIDE
8454 I I 2/28/1990 GRIFFITH MICRO SCI LTD ETO STERILIZATION G. IN BOUND BROOK, NEW
JERSEY
8455 I II 2/15/1990 GANES CHEMICALS INC PENNSVILLE TERFENADINE
8456 I III 3/7/1990 THOROUGHBRED PLASTICS CORP POLYETHYLENE TEREPHTHALATE
8457 I II 3/2/1990 EASTMAN KODAK CO FURIL DIOXIME
8458 I II 2/28/1990 PENINSULA LABS INC DERMORPHIN CODE #8801, LOT # 020746
8459 I II 2/27/1990 NOBEL CHEMS SPA FLUNISOLIDE
8460 A II 3/5/1990 QUIMICA SINTETICA SA CAPTOPRIL
8461 I I 3/5/1990 JANSSEN PHARMACEUTICA INC FACILITIES FOR PARENTERAL FACILITY
8462 I II 2/22/1990 WACKER CHEMIE GMBH 1,3-DICHLOROACETONE
8463 A IV 3/5/1990 LIPOID GMBH LIPOID PG 14:0/14:0 (DMPG-NA 1,2-
DIMYRISTOYL-SN-GLYCERO-3-PHOSPHO-RAC-
GLYCEROL, SODIUM SALT)
8464 A III 3/8/1990 TICONA LLC VECTRA LIQUID CRYSTAL POLYMERS
8465 I II 2/23/1990 IG SPRUHTECHNIK GMBH ALBUTEROL INHALER 90 MCG.
8466 I II 3/12/1990 SYNTHELABO BP L-LYSINE ALPHA KETO BETA METHYLVALERATE -
MONTARGIS CEDEX,FR
8467 I II 3/12/1990 SYNTHELABO BP L-ORNITHINE ALPHA KETO ISOCAPROATE
8468 I II 3/12/1990 SYNTHELABO BP DL-LYSINE ACETYLSALICYLATE
8469 I II 2/14/1990 BROCADES PHARMA BV DIV DRIED BISMUTHSUBCITRATE SOL
YAMANOUCHI GROUP
8470 I I 3/8/1990 BIOCHEMIC GESELLSCHAFT MBH CYCLOSPORIN RECOVERY PLANT
8471 I II 3/21/1990 SUMIKA FINE CHEMICALS CO LTD MICONAZOLE NITRATE
8472 I II 3/12/1990 SUMIKA FINE CHEMICALS CO LTD SULINDAC
8473 I II 3/15/1990 SAFC BIOSCIENCES INC 93% DME (HG)/5% NCTC (CAT. NO. 52-589)
8474 I II 3/15/1990 SAFC BIOSCIENCES INC BIOTAIN-MPS TM CONCENTRATE (100X)
8475 I II 3/15/1990 SAFC BIOSCIENCES INC DMS-12 (100X) CONCENTRATE
Page 267
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8476 I II 3/20/1990 BIOKEN SEPARATIONS INC G. OF ULTRAFILTRATION MEMBRANE
CARTRIDGES
8477 I V 3/20/1990 NATIONAL INSTITUTES HEALTH CURRICULUM VITAE OF THE PEDIATRIC
NATIONAL INSTITUTE ALLERGY INVESTIGATORS FOR AIDS (CTG)
INFECTIOUS DISEASES
8478 I II 3/16/1990 EXPANSIA 5-METHYL-2-(2-THIAZOLYLAMINO) PHENOL
MONOHYDROCHLORIDE
8479 I II 3/9/1990 PFIZER PHARMACEUTICALS INC FACILITY IN NAGOYA, JAPAN
8480 I II 3/14/1990 PENINSULA LABS INC ANGIOTENSIN II
8481 A IV 3/15/1990 ALKERMES INC MEDISORB
8482 I II 3/13/1990 MALLINCKRODT INC THE D-PROPOXYPHENE NAPSYLATE USP CRYSTALS
PHARMACEUTICALS BUSINESS OF
COVIDIEN
8483 I III 3/14/1990 SPARTECH PLASTICS H-S-LD
8484 I II 3/20/1990 MALLINCKRODT BAKER INC PEI BONDED PHASE SILICA GEL
8485 I II 3/22/1990 MARSAM PHARMACEUTICALS INC FACILITIES FOR STERILE FILLING OPERATION IN
CHERRY HILL, NJ.
8486 I II 3/19/1990 INTEROX CHEMICALS LTD MMPP
8487 I II 3/22/1990 ABBOTT LABORATORIES HYROCHLOROQUINE SULFATE
8488 I II 3/19/1990 BIOPRODUCTS FOR SCIENCE INC MANUFACTURING SITE, FACILITY, PERSONEL
AND OPREATING PROCEDURES IN MADISON,
WISCONSIN
8489 I II 3/28/1990 ASTELLAS PHARMA INC CEPHALOSPORIN (ORAL) (FK482 CEFDINIR, CI-
983)
8490 I II 3/20/1990 QUIMICA SINTETICA SA NORFLOXACIN USP XXII
8491 I II 3/23/1990 EASTMAN KODAK CO CIS-4-METHOXYCYCLOHEXYL P-
TOLUNESSULFONATE
8492 I II 3/20/1990 BASF AKTIENGESELLSCHAFT N-[1-(5,6,7,8-TETRAHYDRO-5,5,8,8-
TETRAMETHYL 2-NAPHTHALENYL)
8493 I II 4/2/1990 AVTECH LABORATORIES INC FACILITIES AND PROCEDURES IN KALAMAZOO,
MICHIGAN
8494 I II 3/27/1990 QUIMICA SINTETICA SA RANITIDINE HYDROCHLORIDE
8495 I II 3/27/1990 SIBEFAT SPA LABETALOL HYDROCHLORIDE
8496 I II 3/29/1990 EURAND AMERICA INC DIFFUTAB SIMETRY BASE
8497 I III 3/26/1990 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMULATION B5001-60
GRAY
8498 I II 3/26/1990 BORON BIOLOGICALS INC 10B-ENRICHED D,L-p-BORONO-PHENYLALANINE
Page 268
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8501 I II 3/28/1990 ESTEVE QUIMICA SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BARCELONA, SPAIN.
8502 I II 4/2/1990 PAREKH CHEMICALS ITALIA SPA CEFOPERAZONE ACID
8503 I II 3/23/1990 ATOCHEM PERFLUOROOCTYLBROMIDE C8F17Br
8504 I II 3/28/1990 DAIICHI PHARMACEUTICAL CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN EDOGAWA-KU, TOKYO, JAPAN.
Page 269
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8529 I II 4/16/1990 LEO PHARMACEUTICAL PRODUCTS LTD FUCIDIN OINTMENT
8530 I II 3/23/1990 BANN LABORATORIES INC FACILITIES AND PROCEDURES IN RAHWAY, NEW
JERSEY
8531 I II 4/17/1990 FINE ORGANICS LTD 1,3-DICHLOROACETONE
8532 I II 4/17/1990 GLAXO WELLCOME INC BUILDINGS AND FACILITIES IN SEALS SANDS,
ENGLAND
8533 A III 3/12/1990 SGD SA CLEAR GLASS I CONTAINERS
8534 I I 4/12/1990 GLOBAL PHARMACEUTICALS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN DON MILLS, ONTARIO,
CANADA.
8535 I II 4/12/1990 BILCHEM LTD DEXTROMETHORPHAN HYDROBROMIDE USP
8536 I II 4/3/1990 IND ESQUIMEX SA KM 396 CARRETERA CIMETIDINE
MEX
8537 I II 4/17/1990 BIOSURFACE AB DELMOPINOL HYDROCHLORIDE
8538 I II 4/26/1990 LOFTUS BRYAN CHEMICALS LTD PHENIRAMINE MALEATE
8539 A II 4/23/1990 BAYER AG ACARBOSE
8540 I III 4/23/1990 SEITZ FILTER WERKE SEITZ MEMBRACART (R) NYLON 66 MEMBRANE
8541 I II 4/24/1990 YONEZAWA HAMARI CHEMICALS LTD [(S)-1,2,3,4-TETRAHYDRO-3-ISO-
QUINOLINECARBOXYLIC
8542 I II 4/27/1990 DIOSYNTH BV BUPRENORPHINE
8543 I II 4/11/1990 MEDGENIX GROUP TIRATRICOL 3,5,3 TRIIODOTHYROACETIC ACID
8544 I I 4/20/1990 MANDEVILLE MEDICINES MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN AYLESBURY, ENGLAND.
8545 A II 2/21/1990 IPCA LABORATORIES LTD TRIMETHOPRIM USP
8546 I II 3/2/1990 NATURAL SOURCE VITAMIN E ASSN NATURAL SOURCE VITAMIN E
8547 I II 4/19/1990 LUSOCHIMICA SPA PINDOLOL
8548 I II 5/1/1990 HAMARI CO LTD DILTIAZEM HYDROCHLORIDE
8549 I II 5/1/1990 NIPPON MEKTRON LTD PERFLUOROOCTYLBROMIDE (PFOB), C8F17BR
8550 I II 5/1/1990 NIPPON MEKTRON LTD FACILITIES AND OPERATING PROCEDURES IN
KATAIBARAK, JAPAN
8551 I II 4/23/1990 PLIVA PHARMACEUTICAL CHEMICAL KETOPROFEN
FOOD & COSMETIC INDUSTRY
8552 I II 5/3/1990 IMAGENTS INC RADIOCHEMICAL GALLIUM CHLORIDE GA-67
8553 A II 5/2/1990 YAKULT HONSHA CO LTD CPT-11
8554 I I 4/27/1990 SMITH KLINE & FRENCH LABS DIV MANUFACTURING SITE, FACILITIES,
SMITHKLINE BECKMAN CORP PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN GERMANY.
8555 I III 5/5/1990 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMULATION B-5300-50
GRAY
8556 I II 4/25/1990 FINE CHEMICALS CORP PERPHENAZINE
8557 I III 5/7/1990 COVALENCE COATED PRODUCTS PRODUCTS 41748-30
8558 I III 4/30/1990 TREND PLASTICS SINGLE -DOSE POLYETHYLENE CONTAINER
Page 270
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8559 I I 4/19/1990 ESQUIRE PHARMACEUTICAL MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN WESTMONT, ILLINOIS.
8560 I II 3/17/1990 IPCA LABORATORIES PRIVATE LTD ERTHROMYCIN ESTOLATE
8561 I I 4/27/1990 SURGICAL TECHNOLOGIES MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SAINT PAUL, MINNESOTA.
8562 I II 5/9/1990 ISOCHEM SA FACILITIES AND OPERATING PROCEDURES IN
GENNEVILLER, FRANCE
8563 I II 5/7/1990 AJINOMOTO CO INC CURDLAN SULFATE SODIUM INTRAVENOUS
8564 I II 5/14/1990 MITSUBISHI KASEI CORP CRUDE REPIRINAST (MY-5116)
8565 I II 5/14/1990 DAIICHI PHARMACEUTICAL CO LTD DR-3355 BULK SUBSTANCE
8566 I II 4/9/1990 FARMABOIS FLUNISOLIDE
8567 I II 5/9/1990 BIOINDUSTRIA FARMACEUTICI SPA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN FRESONARA, ITALY.
8568 I II 5/9/1990 EXXONMOBIL CHEMICAL CO AMILORIDE
8569 I III 5/14/1990 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMULATION B-5300-50
CREAM
8570 A V 5/14/1990 SYNERGY HEALTH EDE BV GAMMA IRRADIATION FACILITY LOCATED IN
EDE, THE NETHERLANDS
8571 I II 5/17/1990 RAPID SPRAY GMBH CO KG FACILITY FOR THE G OF AEROSOL SPRAY
CONTAINER
8572 I II 4/10/1990 CELLIANCE A SEROLOGICALS CO PENTEX BOVINE EXCYTE VLE GROWTH
ENHANCEMENT
8573 I II 5/11/1990 QUIMICA SINTETICA SA CINOXACIN USP XXII
8574 I III 5/22/1990 TOKAI ALUMINUM FOIL CO LTD ALUMINUM FOR PHARMACEUTICAL PACKING
PTP
8575 I III 3/2/1990 TOKAI METALS CO LTD E PL-11 FILM
8576 I II 5/21/1990 ORIL INDUSTRIE FACILITIES AND OPERATING PROCEDURES IN
BOLBEC, FRANCE
8577 I II 5/21/1990 ORIL INDUSTRIE INDAPAMIDE
8578 I II 4/19/1990 UNITED COCONUT CHEMICALS FACILITIES AND PROCEDURES IN MAKATI, N.M.,
PHILIPPINES
8579 I II 5/22/1990 DOW CHEMICAL CO POLYGLYCOL E-3350 NF
8580 I II 5/11/1990 RASCHIG GMBH BENZYLAMINOPYRIDINE
8581 I II 5/15/1990 GUANGDONG PHARMACEUTICAL INDOMETHACIN
FACTORY
8582 I II 5/28/1990 DELMAR CHEMICALS INC ETHAMBUTOL DIHYDROCHLORIDE
8583 I II 5/28/1990 PROSINTEX SPA DICLOFENAC SODIUM
8584 A II 5/25/1990 QUIMICA SINTETICA SA ACYCLOVIR
8585 I II 5/29/1990 DAISO CO LTD PINDOLOL
8586 A III 5/29/1990 EXXONMOBIL CHEMICAL CO ISOBUTYLENE ISOPRENE RUBBER, EXXON
CHEMICAL 065
8587 I III 6/1/1990 NATIONAL STARCH AND CHEMICAL CO 28-4979 (DERMACYL-79)
Page 271
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8588 I III 6/4/1990 OWENS BROCKWAY INC PLASTICS AND PACKAGING MATERIALS
CLOSURES DIV
8589 I II 6/5/1990 ABBOTT LABORATORIES DOBUTAMINE HYDROCHLORIDE
8590 A II 6/12/1990 MEDICHEM SA GUANFACINE HYDROCHLORIDE
8591 A III 6/6/1990 FPC FLEXIBLE PACKAGING CORP SUPPOSITORY AND PILLOW PACKAGING
8592 I II 6/8/1990 HOFFMANN LA ROCHE INC TRETINOIN CAPSULES
8593 I III 6/7/1990 KALLE PENTAPLAST GMBH GENOTHERM POLYVINYL CHLORIDE FILM-
GERMANY & THE NETHERLANDS
8594 I I 5/30/1990 DE VONQUE INC FACILITY AND OPERATING PROCEDURES IN
RICHMOND HILL, NEW YORK
8595 I III 6/11/1990 ANGSTROM TECHNOLOGIES INC NON-VISIBLE MATRIX OF PRINTING INKS
8596 I II 6/15/1990 KLINGE PHARMA GMBH DROLOXIFENE CITRATE IN TABLET DOSAGE
FORM
8597 I II 6/12/1990 PENINSULA LABS INC ADRENOCORTICOTROPIC HORMONE
8598 I II 6/15/1990 SHANGHAI NO 2 PHARMACEUTICAL ATENOLOL USP
FACTORY
8599 I II 6/18/1990 KURARAY CO LTD FACILITIES AND OPERATING PROCEDURES IN
NIIGATA, JAPAN.
8600 I II 6/18/1990 KURARAY CO LTD (-) -HPBE
8601 I III 6/11/1990 LOPAREX INC 11005, S 66 #BL KFT L/L 4D/4D
8602 I IV 6/7/1990 NOF CORP PURIFIED EGG YOLK PHOSPHATIDYL CHOLINE
8603 I III 6/11/1990 GW PLASTICS INC ORAL INHALER DEVICE
8604 I II 6/20/1990 NORISTON LTD PYRAZINAMIDE
8605 I IV 4/4/1990 GATTEFOSSE SAS COMPRITO HD5 ATO (GELUCIRE 63/05)
LUBRIFIANT WL 3284 ATO
8606 I II 6/21/1990 WISCONSIN ANALYTICAL AND IMIPRAMINE & DESIPRAMINE IN HUMAN PLASMA
RESEARCH SERVICES LTD
8607 I II 6/22/1990 ALBERMARLE CORP S (+) IBUPROFEN
8608 I III 4/4/1990 SCHUBERT SEALS AS RUBBER COMPOUND 42046
8609 I III 4/4/1990 SCHUBERT SEALS AS RUBBER COMPOUND 42018
8610 I III 4/4/1990 SCHUBERT SEALS AS RUBBER COMPOUND 6247
8611 I III 4/4/1990 SCHUBERT SEALS AS RUBBER COMPOUND 6424
8612 I III 4/4/1990 SCHUBERT SEALS AS RUBBER COMPOUND 6432
8613 I III 4/4/1990 SCHUBERT SEALS AS RUBBER COMPOUND 6433
8614 I III 4/4/1990 SCHUBERT SEALS AS RUBBER COMPOUND 6425
8615 I III 4/4/1990 SCHUBERT SEALS AS RUBBER COMPOUND 6426
8616 I II 6/25/1990 ISOCHEM PHARMACEUTICAL BRAND PROTECTION AND
ANTI-COUNTERFEITING INSTRUMENTATION AND
PROCESS
8617 I III 6/22/1990 3M PHARMACEUTICALS AUTOHALER DEVICE
8618 I II 6/25/1990 EGIS PHARMACEUTICALS PRIVATE LTD SODIUM CROMOGLYCATE
8619 A II 6/27/1990 SCI PHARMTECH INC HYDROXYCHLOROQUINE SULFATE
8620 I III 6/18/1990 VALSPAR KOLACK CORPORATION AG INTERIOR COATING J 3121 PIGMENTED
8621 I IV 6/26/1990 F AND C INTERNATIONAL INC PUNCH FLAVOR #103543
8622 I III 6/21/1990 LOPAREX INC 10688, S 5 MIL BU HDP 4N/000
Page 272
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8623 I II 6/25/1990 BASF AKTIENGESELLSCHAFT 5-ETHENYL-PYRROLIDIN-2-ONE
8624 I II 6/29/1990 DIOSYNTH BV TRIAZOLAM
8625 A II 6/28/1990 CHUNGHWA CHEMICAL SYNTHESIS AND DEXBROMPHENIRAMINE MALEATE
BIOTECH CO LTD
8626 I II 6/22/1990 ISOCHEM SA TERFENADINE
8627 I II 7/2/1990 CIPLA LTD CIPROFLOXACIN HYDROCHLORIDE USP IN
BANGALORE, INDIA
8628 I III 6/26/1990 EXXON CHEMICAL CO ELASTOMERIC MODIFERS, CHEMICAL GRADES
PA23, PA30, PA50
8629 I II 7/3/1990 GLAXO WELLCOME INC FACILITY IN BUCKHAVEN, UNITED KINGDOM
8630 I II 7/3/1990 COURTAULDS FIBRES LTD BISULPHATE ADDUCT
8631 I II 6/27/1990 SHASUN PHARMA SOLUTIONS LTD SULPHONAMIDO ANILINE GR 40917A
8632 I IV 7/6/1990 GATTEFOSSE SAS OCTYLDODECYL MYRISTATE (M.O.D.)
8633 I IV 6/29/1990 LANXESS CORP MACROLEX FLUORESCENT YELLOW 10 GN
8634 I II 7/2/1990 BIOCHEMIC GESELLSCHAFT MBH CEFAZOLIN
8635 I II 7/2/1990 BIOCHEMIC GESELLSCHAFT MBH CEFAZOLIN CRUDE
8636 I IV 6/21/1990 JWS DELAVAU CO INC DELA-COAT CLEAR
8637 I II 7/11/1990 HOFFMANN LA ROCHE INC HIVID DIDEOXYCYTIDINE SYRUP
8638 I II 7/13/1990 PHARMACEUTICAL WORKS POLPHARMA SULFANILAMIDE
SA
8639 I II 7/13/1990 PHARMACEUTICAL WORKS POLPHARMA FACILITIES AND PROCEDURES AT 19
SA PELPLINSKA STR., POLAND
8640 I II 7/13/1990 PHARMACEUTICAL WORKS POLPHARMA FACILITY AND OPERATING PROCEDURES IN 24-
SA 26 STAROGARD, POLAND
8641 I II 7/13/1990 PHARMACEUTICAL WORKS POLPHARMA SULFADIMETHOXINE
SA
8642 I II 7/13/1990 PHARMACEUTICAL WORKS POLPHARMA SULFAQUINOXALINE
SA
8643 I II 7/13/1990 PHARMACEUTICAL WORKS POLPHARMA SULFATHIAZOLE
SA
8644 I II 7/12/1990 NEORX INC RHENIUM RE 188
8645 I II 7/10/1990 SANKYO CO LTD CS-622 DRUG SUBSTANCE
8646 I II 7/10/1990 SANKYO CO LTD CS-622 FINISHED DOSAGE FORM
8647 A II 7/2/1990 JIANGSU HENGRUI MEDICINE CO LTD ETOPOSIDE USP
8648 I II 7/13/1990 MEDICHEM SA AURANOFIN
8649 I II 7/9/1990 SUZHOU NUMBER 1 PHARMACEUTICAL TIMOLOL MALEATE USP
FACTORY
8650 I II 7/3/1990 ROCHE DIAGNOSTICS GMBH GALACTOSE, THERAPEUTIC GRADE
8651 I II 7/9/1990 LABORATOIRES EOLLIEZ SA FACILITY AND OPERATING PROCEDURES IN
COURGEVAUX, SWITZERLAND
8652 I II 7/10/1990 PHARMACIA AND UPJOHN NICOTINE INHALER
8653 I IV 6/30/1990 PROMEDICS HEALTH CARE TOPICALS CHITOSAN SALTS
DIV UNION CARBIDE CORP
8654 I II 7/12/1990 NEW ZEALAND PHARMACEUTICAL LTD FACILITY AND OPERATING PROCEDURES IN
LINTON, NEW ZEALAND
Page 273
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8655 I II 7/12/1990 NEW ZEALAND PHARMACEUTICAL LTD SODIUM CHOLATE (INTERMEDIATE)
8656 A II 7/11/1990 TEVA PHARMACEUTICAL INDUSTRIES CARBIDOPA
LTD
8657 I II 7/16/1990 LIPOID GMBH LIPOID E PC (EGG PHOSPHATIDYLCHOLINE)
8658 I IV 7/17/1990 MOBAY CHEMICAL CORP TEXIN 480A NATURAL
8659 I III 6/18/1990 VALSPAR KOLACK CORPORATION AG INTERIOR COATING J 3121 GOLD TRANSPARENT
Page 275
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8723 I II 8/31/1990 BOEHRINGER INGELHEIM PHARMA SCOPOLAMINE
GMBH AND CO KG
8724 I II 9/7/1990 RAYLO CHEMICALS ACONIAZIDE
8725 I II 9/11/1990 E MERCK EUSOLEX 6300 OIL SOLUBLE UV-B-FILTER
8726 I I 9/11/1990 E MERCK FACILITIES AND PROCEDURES IN GERNSHEIM,
FED. REP. OF GERMANY
8727 I II 9/14/1990 DM GRAHAM LABORATORIES INC IBUPROFEN S (+) TABLETS
8728 I II 9/7/1990 HEUMANN PCS GMBH E-CLOMIPHENE-CITRATE
8729 I II 9/12/1990 SHANGHAI BIOCHEMICAL AND MENOTROPINS
PHARMACEUTICAL LABORATORIES
8730 I II 8/29/1990 SHAKLEE USA INC FACILITY AND OPERATING PROCEDURES G. IN
NORMAN, OKLAHOMA
8731 I II 9/12/1990 ESTEVE QUIMICA SA FACILITY AND OPERATING PROCEDURES
8732 I III 8/29/1990 SCHUBERT SEALS AS RUBBER COMPOUND 36141
8733 A IV 9/17/1990 CELANESE PRODUCTION GERMANY ACESULFAME POTASSIUM
GMBH AND CO KG
8734 I III 8/29/1990 SCHUBERT SEALS AS RUBBER COMPOUND 36140
8735 I II 9/13/1990 PACIFIC NORTHWEST NATIONAL YTTRIUM-90 (Y-90)
LABORATORY
8736 A II 9/13/1990 SYN-TECH CHEM AND PHARM CO LTD CHLORZOXAZONE USP
8737 I I 9/12/1990 NORTHVIEW PACIFIC LABORATORIES MANUFACTURING SITE, FACILITIES,
INC PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BERKELEY, CALIFORNIA.
8738 A III 9/6/1990 SOLVIN SA DIOFAN 193 D
8739 I III 9/4/1990 BASF AKTIENGESELLSCHAFT DIOFAN 185 D
8740 I III 9/4/1990 SOLVIN SA DIOFAN 233 D
8741 I III 9/4/1990 BASF AKTIENGESELLSCHAFT DIOFAN A 735
8742 I III 9/10/1990 BASF AKTIENGESELLSCHAFT TERLUX 2802 TR
8743 I III 9/3/1990 BASF AKTIENGESELLSCHAFT DIOFAN A 710
8744 I II 9/20/1990 KYOWA HAKKO KOGYO CO LTD FACILITIES AND PROCEDURES IN SHIZUOKA
PREFECTURE, JAPAN
8745 I II 9/20/1990 KYOWA HAKKO KOGYO CO LTD CI-920 (FOSTRIECIN) BULK FORM
8746 A II 9/18/1990 TEVA PHARMACEUTICAL INDUSTRIES NAPROXEN SODIUM
LTD
8747 I II 9/19/1990 AVANTI POLAR LIPIDS INC FACILITIES AND OPERATING PROCEDURES IN
ALABASTER, ALABAMA
8748 A II 6/19/1990 TEVA PHARMACEUTICAL INDUSTRIES NAPROXEN
LTD
8749 I II 8/30/1990 ASHWOOD CHEMICALS LTD DIMETHYLAMINOETHYLCHLORIDE HCL
8750 I II 9/17/1990 DUPHAR MEDICAL DEVICES ATROPINE/PRALIDOXIME CHLORIDE INJECTION
(PERFORATED NEEDLE)
8751 I II 9/17/1990 DUPHAR MEDICAL DEVICES ATROPINE/PRALIDOXIME CHLORIDE INJECTION
(RETRACTION NEEDLE)
8752 I II 9/17/1990 BOEHRINGER INGELHEIM PHARMA KG POLY-(D,L-LACTIDE-CO-GLYCOLIDE) 50:50
8753 I II 9/18/1990 SIGMA F AND D DIV LTD D-ARGININE HYDROCHLORIDE
Page 276
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8754 I I 9/26/1990 SUMITRA PHARMACEUTICALS AND FACILITIES AND OPERATING PROCEDURES IN
CHEMICALS LTD ANDHRA PRADESH, INDIA
8755 I II 9/26/1990 SUMITRA PHARMACEUTICALS AND IBUPROFEN
CHEMICALS LTD
8756 I II 9/26/1990 TATEISHI SEIYAKU CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL
8757 A II 9/25/1990 SANDOZ GMBH 6-APA (6 AMINOPENICILLANIC ACID)
8758 I II 10/2/1990 EASTMAN KODAK CO POSITRON EMISSION TOMOGRAPHY (PET)
FACILITIES
8759 I II 10/2/1990 WATSON LABORATORIES INC TRANSDERMAL ESTRADIOL PATCH
8760 A II 9/20/1990 DANIPHARM AS LACTULOSE CONCENTRATE
8761 I III 9/28/1990 ALUMINUM CO AMERICA PHAR 9300
8762 I III 10/1/1990 AVANTI POLAR LIPIDS INC PACKAGING MATERIALS
8763 I III 10/1/1990 AMPACET CORP 11447 WHITE PE/MB
8764 I II 9/26/1990 TEVA PHARMACEUTICAL INC TERFENADINE
8765 I III 9/24/1990 ARKEMA INC PLEXIGLAS DR
8766 I III 9/17/1990 SCHUBERT SEALS AS RUBBER COMPOUND 42047
8767 I III 9/17/1990 SCHUBERT SEALS AS RUBBER COMPOUND 42045
8768 I III 9/17/1990 SCHUBERT SEALS AS RUBBER COMPOUND 42044
8769 I III 9/17/1990 SCHUBERT SEALS AS RUBBER COMPOUND 42043
8770 I III 9/17/1990 SCHUBERT SEALS AS RUBBER COMPOUND 41010
8771 I III 9/17/1990 SCHUBERT SEALS AS RUBBER COMPOUND 41008
8772 I III 9/17/1990 SCHUBERT SEALS AS RUBBER COMPOUND 6446
8773 I III 9/17/1990 SCHUBERT SEALS AS RUBBER COMPOUND 6445
8774 I III 9/17/1990 SCHUBERT SEALS AS RUBBER COMPOUND 6443
8775 I III 9/17/1990 SCHUBERT SEALS AS RUBBER COMPOUND 6442
8776 I III 9/17/1990 SCHUBERT SEALS AS RUBBER COMPOUND 6427
8777 A III 9/28/1990 ST GOBAIN PERFORMANCE PLASTICS RIGID PVC C/1/S 7015 SILICONE RELEASE
COATING
8778 A III 9/24/1990 BASF SE EMULDUR® 381 A
8779 A III 10/5/1990 DUPONT PERFORMANCE POLYMERS HYTREL 8238 POLYESTER ELASTOMER
8780 I II 10/15/1990 PEPTISYNTHA SA FACILITIES AND OPERATING PROCEDURES IN
BRUSSELS, BELGIUM
8781 I V 10/19/1990 NATIONAL INSTITUTES HEALTH REFERENCE INFORMATION (CURRICULA VITAE)
NATIONAL INSTITUTE ALLERGY
INFECTIOUS DISEASES
8782 I II 10/11/1990 LUBRIZOL ADVANCED MATERIALS INC CARBOPOL SALTS
8783 I III 10/17/1990 LOPAREX LLC GRADE 10929 S #53 SB SCK 7967/000
8784 A II 10/12/1990 FINORGA SAS ADAPALENE
8785 I I 10/10/1990 MADIS LABORATORY FACILITIES AND OPERATING PROCEDURES IN
SOUTH HACKENSACK, NJ
8786 A V 10/16/1990 PHARMACHEMIE BV STERILE MANUFACTURING FACILITY IN
HAARLEM,NETHERLANDS
8787 I II 10/10/1990 BIOSPECIA LTD HUMAN CHORIONIC GONADOTROPHIN
Page 277
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8788 I III 10/21/1990 ARCO CHEMICAL CO DIV ATLANTIC FIBERSORB SUPERABSORBENT MATERIALS
RICHFIELD CO 7000, 7200 AND 7500 IN PA
8789 I IV 10/9/1990 HERCULES INC PENTALYN H SYNTHETIC RESIN
8790 I III 10/1/1990 BASF AKTIENGESELLSCHAFT LUPOLEN 3025 K
8791 A III 10/5/1990 LOPAREX LLC FLIM BASED 4400 SERIES COATED RELEASE
LINERS
8792 I II 10/22/1990 NIPPON STEEL CHEMICALS CO LTD (S)-1,2,3,4-TETRAHYDROISOQUINOLINE-3-
CARBOXYLIC ACID-JAPAN
8793 I II 10/19/1990 BACHEM FEINCHEMIKALIEN AG CYT-379
8794 I II 10/18/1990 EGIS PHARMACEUTICALS PRIVATE LTD NIFEDIPINE
8795 I I 10/25/1990 GLAXO OPERATIONS UK LTD FACILITIES AND OPERATING PROCEDURES AT
BARNARD CASTLE, UK
8796 I III 9/7/1990 TOYO ALUMINIUM KK PAPER/LDPE/AL
FOIL/ADHESIVE/ACRYLONITRILE FILM IN JAPAN
8797 I I 10/10/1990 KLINGE PHARMA GMBH MANUFACTURING FACILITY IN KILLORGLIN,
IRELAND
8798 A III 10/17/1990 LOPAREX BV GELROLEASE 111/80, PS 29.701
8799 I II 10/23/1990 TATEISHI SEIYAKU CO LTD DILTIAZEM HYDROCHLORIDE
8800 I II 10/25/1990 DELMAR CHEMICALS INC PYRIDOSTIGMINE BROMIDE
8801 I II 10/29/1990 HAUSER CHEMICAL RESEARCH INC TAXOL
8802 I II 10/24/1990 GEDEON RICHTER LTD DIHYDROLYSERGOL
8803 A III 10/24/1990 LAUFENBERG GMBH PET-FILM, TRANSPARENT, ONE SIDE PRINTED
OR ALUMINIZED, ONE OR BOTH SIDE
SILICONIZED
8804 I II 11/1/1990 MALLADI DRUGS AND EPHEDRINE HYDROCHLORIDE
PHARMACEUTICALS LTD
8805 I II 10/31/1990 SUMITOMO CHEMICAL CO LTD GLIPIZIDE
8806 A II 10/30/1990 GEDEON RICHTER PLC LEVONORGESTREL, USP
8807 I III 11/2/1990 NYPRO CAROLINA MOLDED MEMBRANE PORT #03-20-16-422
8808 I II 10/31/1990 WATSON LABORATORIES INC IRON DEXTRAN, 5% SOLUTION
8809 I II 10/31/1990 CILAG AG 2-BENZYLAMINO-PYRIDINE
8810 I II 11/6/1990 AMERSHAM CORP YTTRIUM CHLORIDE (Y-90)
8811 I II 9/18/1990 PIONEER PHARMACEUTICALS INC ELMIRON (PENTOSAN POLYSULFATE
SODIUM)CAPSULES 100MG, NJ
8812 I II 11/5/1990 PROFARMACO SRL LOXAPINE SUCCINATE
8813 I II 11/5/1990 FAR RESEARCH INC FACILITY IN PALM BAY, FLORIDA
8814 I II 11/5/1990 FAR RESEARCH INC MONOBENZONE
8815 I II 11/9/1990 ASAHI GLASS CO LTD PERFLUOROOCTYLBROMIDE
8816 I II 11/9/1990 ASAHI GLASS CO LTD FACILITES AND OPERATING PROCEDURES IN
CHIBA, JAPAN
8817 I II 11/6/1990 AVANTI POLAR LIPIDS INC GLYCEROPHOSPHOCHOLINE.CdC12.CELITE
8818 I II 11/7/1990 SIGNA SA DE CV AZT (ZIDOVUDINE)
8819 I II 11/9/1990 ROUSSELL UCLAF ESTRADIOL
8820 I II 11/9/1990 CYCLO PRODUCTS INC BIOTIN
8821 I II 10/31/1990 PFIZER INC TRIAMCINOLONE ACETONIDE
Page 278
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8822 I II 10/11/1990 SCHOELLER AND HOESCH GMBH GEFOLUX TDS/HF
8823 I III 10/11/1990 SCHOELLER AND HOESCH GMBH GEFOLUX TDS/M
8827 I II 11/9/1990 HASHIMOTO CHEMICAL INDUSTRIES CO SODIUM FLUORIDE
LTD
8828 I II 11/20/1990 KYOWA HAKKO KOGYO CO LTD ADENOSINE
8829 I II 11/16/1990 HAIMEN PHARM FACTORY DAUNORUBICIN HYDROCHLORIDE
8830 I IV 11/8/1990 SC JOHNSON AND SON INC PRIMAFRESH HS
8831 I II 11/15/1990 IAF BIOCHEM INTERNATIONAL INC ACONIAZIDE TABLETS 650 MG.
8832 I II 11/15/1990 CREATIVE PRODUCTS INC FACILITIES AND OPERATING PROCEDURES IN
ROSSVILLE, ILLINOIS
8833 A III 11/5/1990 DANAPAK FLEXIBLES AS COMPOUND PACKAGING MATERIAL
8834 I II 10/10/1990 ARCHIMICA SPA ATENOLOL
8835 I III 10/31/1990 LOHMANN GMBH AND CO KG PARATEX III/40
8836 A V 11/16/1990 STERIS CONTRACT STERILIZATION FACILITY IN
SPARTANBURG, SOUTH CAROLINA
8837 A III 11/19/1990 HUECK FOLIEN GESELLSCHAFT MBH METALLIZED POLYESTER FILMS
8838 I II 11/9/1990 RECORDATI INDUSTRIA CHIMICA SPA METOPROLOL TARTRATE
8839 I II 11/12/1990 KYOWA HAKKO USA INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ASHIKAGA-SHI, JAPAN.
8840 I II 11/16/1990 SIPSY SNC TRICAINE METHANE SULFONATE
8841 I I 11/21/1990 KINERTON LTD FACILITY AND OPERATING PROCEDURES IN
BLANCHARDSTOWN, IRELAND
8842 I I 11/16/1990 MALLINCKRODT CANADA INC FACILITIES AND OPERATING PROCEDURES IN
POINTE CLAIRE, CANADA
8843 I II 11/15/1990 KOPRAN LTD AMPICILLIN TRIHYDRATE
8844 I II 11/15/1990 KOPRAN LTD CLOXACILLIN SODIUM
8845 I II 11/15/1990 KOPRAN LTD AMOXYCILLIN TRIHYDRATE
8846 I II 11/15/1990 KOPRAN LTD FACILITIES AND OPERATIONS IN
MAHARASHTRA, INDIA
8847 I II 11/16/1990 MALLINCKRODT CANADA INC X-RAY CONTRAST MEDIA
8848 I II 8/10/1990 3M HEALTH CARE LTD SALSALATE
8849 I II 8/10/1990 3M HEALTH CARE LTD MANUFACTURE OF FLECAINIDE ACETATE
8850 I II 11/16/1990 MALLINCKRODT CANADA INC HEXABRIX X-RAY CONTRAST MEDIA
8851 I II 11/21/1990 BACHEM INC Eel CALCITONIN
8852 I II 11/21/1990 ACS DOBFAR SPA 7-AMINO-3-CHLORO CEPHEM ESTER
8853 I II 11/21/1990 QUIMICA SINTETICA SA CHLORAMPHENICOL PALMITATE
8854 I II 11/27/1990 NIPPON FINE CHEMICAL CO LTD MANUFACTURTING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN HYOGO, JAPAN.
8855 A II 11/26/1990 ASPEN OSS BV 16-ALPHA-HYDROXYPREDNISOLONE
8856 A II 11/20/1990 CHEMWERTH INC DOBUTAMINE HYDROCHLORIDE
8857 I I 11/4/1990 GENZYME CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN HAVERHILL, ENGLAND.
Page 279
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8858 I II 11/29/1990 PERRIGO API LTD PENTOXIYFYLLINE
8859 I II 11/26/1990 ZAMBON SPA TRIAZOLAM
8860 I II 11/26/1990 ZAMBON SPA ALPRAZOLAM
8861 I II 11/29/1990 RIEDEL DEHAEN AG BENZOPHENONE -3 (OXYBENZONE)
8862 I V 11/20/1990 PHARMACONSULT INC DRUG INTERACTION STUDY ON
BROMOCRIPTINE AND TORECAN
8864 A II 11/19/1990 LUNDBECK PHARMACEUTICALS ITALY CLOMIPRAMINE HYDROCHLORIDE
SPA
8865 I II 11/30/1990 TAENAKA KOGYO CO LTD FACILITIES AND OPERATING PROCEDURES IN
MOBARA CITY, JAPAN
8866 A II 11/30/1990 TAENAKA KOGYO CO LTD L-CYSTEINE MONOHYDROCHLORIDE
MONOHYDRATE
8867 I III 11/11/1990 FRANTSCHACH INNCOAT GMBH AZETIN SILAZET
8868 I II 11/30/1990 ORLOVE GROUP FACILITIES AND OPERATING PROCEDURES IN
FORT LAUDERDALE, FLA.
8869 I II 12/3/1990 BIOCHEMIE SA ANHYDROUS AMPICILLIN INTERMEDIATE NON-
STERILE BULK
8870 I III 12/4/1990 AMCOR FLEXIBLES ITALIA SRL PAPER/ALUMINUM/POLYETHYLENE LAMINATE
DRUG
8871 I IV 11/30/1990 HENRY H OTTENS MANUFACTURING CO ARTIFICIAL BING CHERRY AND CHERRY
INC RASPBERRY FLAVORS
8872 I II 12/4/1990 BRISTOL MYERS PRODUCTS DIV TRI-BUFFERED BUFFERIN
BRISTOL MYERS CO
8873 I III 12/6/1990 OWENS ILLINOIS INC PACKAGING MATERIALS
8874 I II 12/4/1990 QUIMICA SINTETICA SA ACEBUTOLOL HYDROCHLORIDE
8875 I II 11/28/1990 DENKA PHARMCEUTICAL CO LTD MENOTROPIN
8876 I II 12/14/1990 AVECIA INC SDM-75 (20 % NITROGLYCERIN IN SOLVATED
ACRYLATE POLYMER)
8877 I II 12/10/1990 IMHAUSEN CHEMIE GMBH FACILITIES AND GENERAL OPERATING
PROCEDURES IN LAHR, GERMANY
8878 I III 12/6/1990 4P FOLIE FORCHHEIM GMBH PVC RIGID FILM 41121
8879 I III 12/6/1990 4P FOLIE FORCHHEIM GMBH PVC RIGID FILM 51520
8880 I II 12/7/1990 FINE ORGANICS LTD S-1,2,3,4-TETRAHYDROISOQUINOLINE-3- ACID
SALT
8881 A III 12/10/1990 TAISEI KAKO CO LTD MANUFACTURING OF GLASS VIALS FOR
PHARMACEUTICAL USE
8882 A III 12/10/1990 TAISEI KAKO CO LTD MANUFACTURING OF EYE DROP CONTAINERS
8883 A III 12/10/1990 TAISEI KAKO CO LTD PTP-SHEETS FOR PKG. TABLETS AND
CAPSULES
8884 A III 12/10/1990 TAISEI KAKO CO LTD MANUFACTURING OF WIDE ORIFICE BOTTLES
AND CLOSURES FOR ORAL TABLETS, ORAL
CAPSULES AND ORAL POWDERS
8885 I II 12/7/1990 REPLIGEN CORP FAST FLOW IMMOBILIZED RECOMBINANT
PROTEIN A IN MASSACHUSETTS
8886 I II 12/10/1990 FINE ORGANICS LTD SULPHAZINE
Page 280
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
8887 I II 12/11/1990 DAIICHI PHARMACEUTICAL CO LTD PANTETHINE BULK SUBSTANCE
8888 A II 12/13/1990 VERTELLUS GREENSBORO LLC ACETYLTRI-N-HEXYL CITRATE (ATHC)
8889 I III 12/11/1990 FOLIENWALZWERK BRUEDER TECH DOUBLE LAMINATED FOIL OPA/ALU/PVC
AKTIENGESELLSCHAFT
8890 I II 6/28/1990 DAIICHI PHARMACEUTICAL CO LTD PANTOSIN 200 MG TABLETS
8891 I II 12/12/1990 SUN CHEMICAL CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SAITAMA, JAPAN.
8892 I II 12/13/1990 BACHEM AG CALCITONIN (SALMON) (BULK)
8893 I II 12/17/1990 KYOWA HAKKO BIO CO LTD MANUFACTURING AND QUALITY INFORMATION
ON L-GLUTATHIONE REDUCED
8894 I I 12/10/1990 MIDWEST RES INST MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MISSOURI.
8895 I IV 12/10/1990 AMICON DIV WR GRACE AND CO MATREX SILICA PAE MEDIA
8896 I II 12/18/1990 LEO PHARMACEUTICAL PRODUCTS LTD FUCIDIN GEL DRUG PRODUCT
Page 287
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9097 I I 4/11/1991 MERCK SHARP & DOHME RESEARCH MANUFACTURING SITE, FACILITIES,
LABS, DEVELOPMENT LABS PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN HODDESDON, HERTFORD,
UNITED KINGDOM.
9099 I II 4/30/1991 KERFOOT PHARMACEUTICALS KETOPROFEN
9100 I II 5/6/1991 HOECHST MARION ROUSSEL SA HYDROXOCOBALAMIN BASE
9102 I II 5/2/1991 SIPSY CHIMIE FINE SCA BUTOXOCORT PROPIONATE
9103 I II 4/30/1991 SIPSY SNC AMIFOSTINE
9104 A II 5/15/1991 SIEGFRIED PHARMACHEMIKALIEN XYLOMETAZOLINE HYDROCHLORIDE
MINDEN GMBH
9105 I I 4/3/1991 VITA TECH INTERNATIONAL INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN TUSTIN, CALIFORNIA.
9106 I II 5/6/1991 FARMITALIA CARLO ERBA SPA FCE 23884 A DRUG SUBSTANCE
9107 I II 5/6/1991 FARMITALIA CARLO ERBA SPA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF FCE 23884 IN MILAN, ITALY.
9108 I II 5/6/1991 FARMITALIA CARLO ERBA SPA FCE 23884 0.20 AND 0.50 MG TABLETS
9109 I II 5/7/1991 MALLINCKRODT CHEMICAL INC OXYMORPHONE HYDROCHLORIDE
9110 I II 5/6/1991 SIEGFRIED AG METOPROLOL TARTRATE
9111 I II 5/14/1991 YUKI GOSEI KOGYO CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF SULFADIAZINE SILVER IN
JAPAN.
9112 I II 5/14/1991 YUKI GOSEI KOGYO CO LTD SULFADIAZINE SILVER
9113 I I 4/30/1991 MERCK AG STERILE MANUFACTURING FACILITY
9114 I II 4/22/1991 FINAF 92 SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN TARRAGONA, SPAIN.
9115 A II 4/22/1991 ESTEVE QUIMICA SA DICLOFENAC SODIUM
9116 I II 5/7/1991 PHARMA TECHNOLOGY INDUSTRIES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN UNION, MISSOURI.
9117 I III 5/7/1991 NATIONAL WAX CO CEREPLAX 4628 WAX COATING
9118 A II 5/13/1991 ARCH PHARMALABS LTD PIROXICAM USP
9119 I II 5/13/1991 ARCH PHARMALABS LTD IBUPROFEN
9120 I II 5/13/1991 SEKHSARIA CHEMICALS PRIVATE LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN THANE, INDIA
9121 I II 4/30/1991 YUNG SHIN PHARMACEUTICAL MANUFACTURING SITE, FACILITIES,
INDUSTRIES CO LTD PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN TAIWAN, CHINA.
9122 I II 5/16/1991 PHARMACIA AND UPJOHN MANFACTURING SITE, FACILITIES, PERSONNEL,
AND GENERAL OPERATING PROCEDURES IN
JOHANNESHOV, SWEDEN.
Page 288
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9126 I III 5/13/1991 STYROLUTION EUROPE GMBH LURAN 368 R
9127 I II 5/20/1991 NV ORGANON BUTORPHANOL TARTRATE
9128 I II 5/20/1991 DIOSYNTH BV ALPRAZOLAM
9129 I II 5/15/1991 PFANSTIEHL LABORATORIES INC SUCROSE, N.F. (HIGH PURITY)
9130 I III 5/17/1991 HELVOET PHARMA MARYLAND RUBBER CLOSURE R2502-50 TAN
9131 A II 5/9/1991 ASPEN OSS BV HEPARIN SODIUM USP
9132 I II 4/30/1991 ONY INC INFASURF
9133 I II 5/20/1991 ELDER PHARMACEUTICALS LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN NEW BOMBAY, INDIA.
9134 I III 5/22/1991 CONSOLIDATED CONTAINER CO LLC CONTAINERS
9135 I III 5/15/1991 BASF AKTIENGESELLSCHAFT NOVOLEN 1100 N
9136 A II 5/20/1991 GEDEON RICHTER PLC NORGESTREL USP
9137 I III 5/22/1991 CROWN CORK AND SEAL CO INC PILFER PROOF CAP
9138 I III 5/15/1991 UNION CAMP CORP PAPER/LOW DENSITY POLYETHYLENE
9139 I II 5/29/1991 FRONTIER SCIENTIFIC INC NPe6 DRUG SUBSTANCE
9140 I II 5/21/1991 SCHERING AG ILOPROST
9141 I II 5/16/1991 INSTITUTE CLINICAL PET F-18 FLUDEOXYGLUCOSE (MICHIGAN
SYNTHESIS)
9142 I IV 5/24/1991 DS INDUSTRIE APS ESTARAM T SUPPOSITORY BASES
9143 I II 5/31/1991 ABBOTT LABORATORIES ARBUTAMINE
9144 I II 5/30/1991 EGIS PHARMACEUTICALS PRIVATE LTD SULFAMETHOXAZOLE
9145 I III 5/23/1991 MITSUI CHEMICALS INC TPX
9146 A III 5/29/1991 BOREALIS AG BORMED DM55PHARM
9147 A II 5/31/1991 PFANSTIEHL INC SODIUM GLUCONATE, USP (S-108)
9148 I II 5/21/1991 YUKI GOSEI KOGYO CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF PROTAMINE SULFATE IN
TOKYO, JAPAN.
9149 I II 6/5/1991 FINE CHEMICALS CORP INDAPAMIDE
9150 I II 6/3/1991 MICRA BIOTECHNOLOGIES INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN FORT LEE, NEW JERSEY.
9151 I II 6/5/1991 NIPPON FINE CHEMICAL CO LTD PHOSPHOLOPID DMPG
9152 I II 5/21/1991 DIACEL CHEMICAL INDUSTRIES LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN AARI-CITY, JAPAN.
9153 I III 5/24/1991 UNITED CLOSURES AND PLASTICS PLC X825 PLASTIC CLOSURE MATERIAL
9154 I II 6/4/1991 GATTEFOSSE AG MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN LUCERNE, SWITZERLAND.
9155 A IV 6/10/1991 ROQUETTE FRERES BETA CYCLODEXTRIN
9156 I II 6/7/1991 RASCHIG GMBH EMORFAZONE, CLINICAL AND PRE-CLINICAL
STUDIES
9157 I II 6/6/1991 SUMITOMO CHEMICAL CO LTD TERAZOSIN HYDROCHLORIDE
Page 289
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9158 A II 5/3/1991 ZACH SYSTEM SA 4-METHOXY-2,3,6-TRIMETHYLBENZALDEHYDE
9159 I II 6/4/1991 SYNTHELABO BP ZOLPIDEM TARTRATE
9160 I II 6/10/1991 PENINSULA LABS INC PEPTIDE E
9161 I II 6/11/1991 FARMHISPANIA SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BARCELONA, SPAIN.
9162 I II 6/12/1991 PHARMACEUTICAL WORKS POLPHARMA NIFEDIPINE
SA
9163 I IV 2/25/1991 POLIOLES SA DE CV POLYETHYLENE GLYCOLS (PEG'S)
9164 I IV 2/25/1991 POLIOLES SA DE CV PROPYLENE GLYCOL (MPG) AND DYPROPYLENE
GLYCOL IN MEXICO
9165 I II 6/13/1991 NORAMCO DELAWARE INC PERINDOPRIL ERBUMINE
9166 I II 4/4/1991 FERSINSA GIST BROCADES SA DE CV 7-ADCA
9167 A II 6/11/1991 EXCELLA GMBH AND CO KG BUSPIRONE HYDROCHLORIDE
9168 I I 6/13/1991 JB LABS FACILITY AND OPERATING PROCEDURES IN
HOLLAND, MICHIGAN
9169 I II 6/12/1991 ROMAN INDUSTRIES CO LTD UROFOLLITROPIN
9170 I II 6/12/1991 ROMAN INDUSTRIES CO LTD MENOTROPINS
9171 I II 6/10/1991 ORIL INDUSTRIE PERINDOPRIL ERBUMINE
9172 I II 6/14/1991 BAYER AG METRIFONATE DRUG SUBSTANCE
9173 I II 6/14/1991 BAYER AG METRIFONATE DRUG PRODUCT
9174 I III 5/23/1991 COSTAR NUCLEPORE QMC CARTRIDGE MEDIA FILTERS
9175 I III 5/23/1991 COSTAR NUCLEPORE QR2 CARTRIDGE FILTERS
9176 I III 5/23/1991 COSTAR NUCLEPORE QS CARTRIDGE FILTERS
9177 I II 6/13/1991 GIULINI CHEMIE GMBH DIHYDROXY ALUMINUM SODIUM CARBONATE -
LUDWIGSHAFEN, GERMANY
9178 I I 6/17/1991 VAN DEN BERGH FOODS CO FACILITIES AND OPERATING PROCEDURES IN
JOLIET, ILLINOIS
9179 I II 6/11/1991 ZACH SYSTEM 1,3 PROPANEDIOL 2 PHENYL
9180 I III 6/11/1991 SPARTECH PLASTICS THERMOPLASTIC SHEET PES-HD-PES
9181 I III 6/11/1991 SPARTECH PLASTICS THERMOPLASTIC SHEET PES-PP-PES
9182 A III 6/11/1991 AMPACET CORP 11246 BLUE-WHITE PEMB
9183 I IV 6/12/1991 ALZA CORP GITS
9184 I II 6/25/1991 ABIC LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN NETANYA, ISRAEL.
9185 I II 6/14/1991 QUIMICA SINTETICA SA MEFENAMIC ACID
9186 I II 6/21/1991 PERIMMUNE INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF LAK CELLS.
9187 I II 6/17/1991 PFANSTIEHL LABORATORIES INC PODOPHYLLOTOXIN
9188 I II 6/25/1991 FERMION OY PRAZOSIN HYDROCHLORIDE
9189 I II 6/14/1991 QUIMICA SINTETICA SA BUSPIRONE
9190 I III 7/30/1991 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMULATION B5002-45
RED
Page 290
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9191 A II 6/17/1991 IRE SODIUM MOLYBDATE MO-99 (FISSON)
9192 A II 6/24/1991 AVANTI POLAR LIPIDS INC 1,2-DIOLEOYL-SN-GLYCERO-3-
PHOSPHOETHANOLAMINE (DOPE) (770725)
9193 I I 6/25/1991 KNOLL PHARMA CHEMICALS MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN NOTTINGHAM, ENGLAND.
9194 I II 6/13/1991 APPLIED BIOSYSTEMS ISIS 1082
9195 I II 6/13/1991 APPLIED BIOSYSTEMS FACILITIES IN FOSTER CITY, CA. (TRANS. TO
BIOLOGICS-7/10/91)
9196 I II 6/26/1991 PERIMMUNE INC ATENOLOL
9197 I III 6/26/1991 AMPACET CORP 11171 WHITE PE MB
9198 I II 6/26/1991 BPRL FINE CHEMICALS PRIVATE LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN KARNATAKA, INDIA.
9199 I III 6/20/1991 TRICON HOSTAPHAN RN 100
9200 I II 6/26/1991 ORION CORP LTD TRIAZOLAM
9201 A IV 6/17/1991 ITACEL FARMOQUIMICA LTDA MICROCEL MICROCRYSTALLINE CELLULOSE
9202 I II 6/28/1991 SOCHINAZ SA FACILITIES AND OPERATING PROCEDURES IN
VIONNAZ, SWITZERLAND
9203 I II 6/27/1991 ASTA MEDICA AG FACILITIES AND OPERATING PROCEDURES IN
CARINTHIA, AUSTRIA
9204 I I 6/24/1991 LIBBY LABS MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BERKELEY, CALIFORNIA.
9205 A III 6/24/1991 SCHOTT SCHWEIZ AG PRIMARY PACKAGING MATERIAL (VIALS,
CARTRIDGES)
9206 A III 6/24/1991 SCHOTT DE MEXICO SA DE CV PRIMARY PACKAGING MATERIAL (VIALS,
AMPOULES, SYRINGES, CARTRIDGES)
9207 I II 7/1/1991 CHISSO CORP CM CELLUFINE C - 200
9208 I II 7/1/1991 CHISSO CORP DEAE CELLUFINE A - 200
9209 I II 7/1/1991 CHISSO CORP CM CELLUFINE C - 500
9210 I II 7/1/1991 CHISSO CORP CM CELLUFINE C - 40
9211 I II 7/1/1991 CHISSO CORP DEAE CELLUFINE A - 800
9212 I II 7/1/1991 CHISSO CORP DEAE CELLUFINE A - 500
9213 I II 6/25/1991 NEN LIFE SCIENCE PRODUCTS YTTRIUM-90 (YTTRIUM CHLORIDE)
9214 I II 6/25/1991 EI DUPONT DE NEMOURS AND CO INC RHENIUM-186 AS SODIUM PERRHENATE
(NaRe04)
9215 I III 7/3/1991 4P FOLIE FORCHHEIM GMBH EUROPHAN FILM QUALITY 89014
9216 I II 6/21/1991 NV ORGANON PYRIDOSTIGMINE BROMIDE
9217 A III 5/31/1991 UNITED CLOSURES AND PLASTICS LTD CLICLOC CLOSURES
9218 I II 5/15/1991 OMNICHEM SA NEFAZODONE II
9219 I II 7/3/1991 CIPLA LTD PODOPHYLLOTOXIN
9220 I IV 5/12/1991 CAPSPHARMA ENTERPRISE LTD EMPTY HARD GELATIN CAPSULES
SCIENCE BASED INDUSTRIES CAMPUS
9221 I II 7/3/1991 EGIS PHARMACEUTICALS PRIVATE LTD CAPTOPRIL
Page 291
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9222 I I 7/16/1991 CHEMIE LINZ AG FACILITY IN LINZ, AUSTRIA
9223 I IV 6/26/1991 GIVAUDAN ROURE CORP FRAGRANCE PA-71038
9224 I III 7/9/1991 NESTE CHEMICALS POLYPROPYLENE PRODUCT XB18 66MN
9225 I II 6/28/1991 VEGEFLORA EXTRACOES DO PILOCARPINE NITRATE
NORDESTE LTDA
9226 I II 7/9/1991 NESTE CHEMICALS FACILITIES AND OPERATING PROCEDURES IN
PORVOO, FINLAND
9227 I V 6/10/1991 NATIONAL INSTITUTES HEALTH ANTIVIRAL STUDY GROUP INFORMATION TO
NATIONAL INSTITUTE ALLERGY AND SUPPORT CLINICAL STUDIES
INFECTIOUS DISEASES
9228 A II 7/11/1991 AVARA SHANNON PHARMACEUTICAL ISOSORBIDE DINITRATE DILUTED
SERVICES LTD
9229 I II 7/9/1991 MDS NORDION SODIUM IODIDE I-131
9230 I II 7/10/1991 WYCKOFF CHEMICAL CO INC SELEGILINE HYDROCHLORIDE
9231 A II 7/11/1991 BACHEM SA CARBIDOPA
9232 I II 8/1/1991 DIOSYNTH BV NOMEGESTROL ACETATE
9233 I III 7/29/1991 3M PHARMACEUTICALS PHARMACEUTICAL GRADE TRANSFER
ADHESIVE
9234 I I 7/2/1991 E MERCK (INDIA) LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF CHLOROQUIN PHOSPATE IN
INDORE, INDIA
9235 A II 7/2/1991 IPCA LABORATORIES LTD CHLOROQUINE PHOSPHATE USP
9236 I II 7/2/1991 IPCA LABORATORIES LTD FACILITY FOR BULK DRUG PRODUCTION IN
INDORE INDIA
9237 A II 7/2/1991 IPCA LABORATORIES LTD PROBENECID USP
9238 I II 7/2/1991 BDH PHARMACEUTICALS LTD IBUPROFEN BULK DRUG SUBSTANCES
9239 I II 7/10/1991 GLAXO WELLCOME INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BOMBAY, INDIA.
9240 I II 7/10/1991 BURROUGHS WELLCOME INDIA LTD TRIMETHOPRIM BULK DRUG PRODUCT
9241 I II 7/15/1991 MEDEA RESEARCH LABORATORIES INC HYDROXYUREA
9242 I II 7/16/1991 SANDOZ PHARMA LTD TIZANIDINE HYDROCHLORIDE
9243 I II 7/16/1991 HISAMITSU PHARMACEUTICAL CO INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN TOKYO, JAPAN.
9244 I I 7/15/1991 KOS PHARMACEUTICALS INC FACILITIES AND PROCEDURES IN HOLLYWOOD,
FLORIDA AND AKRON,OHIO
9245 I III 7/11/1991 AMPACET CORP 11418-F WHITE HDPE MB
9246 I III 7/10/1991 BASF AKTIENGESELLSCHAFT ULTRAPEK KR 4175, 4176, 4177 AND 4178
9247 I III 7/16/1991 AMPACET CORP 11912 WHITE PE MB
9248 I II 7/3/1991 SIGMA F AND D DIV LTD N-DODECYL B-D-MALTOSIDE, PRODUCT NO. D
4641 IN ST.LOUIS, MO.
Page 292
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9249 I II 6/19/1991 CHEDOKE MCMASTER HOSP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN HAMILTON, ONTARIO,
CANADA.
9250 I II 6/19/1991 CHEDOKE MCMASTER HOSP 18F 2-FLUORO-2-DEOXYGLUCOSE
9251 I II 7/18/1991 ORION CORP LTD DEXMEDETOMIDINE
9252 I I 7/19/1991 GRUPPO LEPETIT SPA FACILITIES AND PROCEDURES IN GERENZANO
(VARESE), ITALY
9253 I III 7/22/1991 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMULATION B-5001-55
PEARL GRAY-SALISBURY,MD
9254 I III 9/6/1988 3M DRUG DELIVERY SYSTEMS SCOTCHPAK BRAND HEAT SEALABLE
POLYESTER FILM NO. 113
9255 I V 7/22/1991 DRAXIMAGE DIV DRAXIS SPECIALTY MANUFACTURING SITE, FACILITIES,
PHARMACEUTICALS INC PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN KIRKLAND, QUEBEC, CANADA.
Page 294
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9308 I II 8/29/1991 CHISSO CORP OCTYL-CELLUFINE HYDROPHOBIC
INTERACTION CHROMATOGRAPHY MEDIA
9309 I II 8/29/1991 CHISSO CORP PHENYL-CELLUFINE HYDROPHOBIC
INTERACTION CHROMATOGRAPHY MEDIA
9310 I II 8/29/1991 CHISSO CORP FORMYL-CELLUFINE AN AFFINITY
CHROMATOGRAPHY MEDIA
9311 I II 8/29/1991 CHISSO CORP HYDROPHOBIC INTERACTION
CHROMATOGRAPHY MEDIA
9312 I II 8/30/1991 CYANAMID UK LTD PROPRANOLOL HYDROCHLORIDE
9313 I II 8/27/1991 SHANGHAI BIOCHEMICAL AND MANUFACTURING FACILITIES FOR CHORIONIC
PHARMACEUTICAL LABORATORIES GONADOTROPIN IN CHINA
9314 I II 8/30/1991 REXAM CLOSURES AND CONTAINERS MANUFACTURING SITE, FACILITIES,
PERSONNEL AND GENERAL OPERATING
PROCEDURES IN EVANSVILLE AND PRINCETON,
INDIANA
9315 I III 8/27/1991 BASF AKTIENGESELLSCHAFT POLYSTYROL 436C
9316 I III 8/27/1991 BASF AKTIENGESELLSCHAFT ULTRAFORM W2320 007
9317 I II 9/2/1991 SUMIKA FINE CHEMICALS CO LTD NIFEDIPINE
9318 I II 9/4/1991 TILLOTTS PHARMA AG MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ZIEFEN, SWITZERLAND.
9319 A III 8/26/1991 WATSON STANDARD ADHESIVES CO COATING FOR PHARMACEUTICAL PACKAGING
9320 I II 8/30/1991 BIOSPECIA LTD MENOTROPIN
9321 I III 9/3/1991 OWENS ILLINOIS INC THERMOPLASTIC CLOSURES AND PACKAGING
9322 I II 9/3/1991 THATCHER CHEMICAL CO HEXACHLOROPHENE SOAP SOLUTION
9323 A IV 9/5/1991 EASTMAN CHEMICAL CO EASTMAN CELLULOSE ACETATE (CA-398-10
NF/EP)
9324 I II 9/5/1991 SAUTER LABORATORIES LTD FACILITIES AND OPERATING PROCEDURES IN
GENEVA, SWITZERLAND
9325 I II 9/3/1991 ALPS PHARMACEUTICAL IND CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN KAMINO, JAPAN.
9326 I II 9/3/1991 ALPS PHARMACEUTICAL IND CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MUKAIMACHI, JAPAN.
9327 I III 9/6/1991 AMPACET CORP 10358-F SLIP PE MB
9328 I III 9/6/1991 AMPACET CORP 10477-F ANTIBLOCK PE MB
9329 I II 9/4/1991 BACHEM FEINCHEMIKALIEN AG H-LEU-LEU-OME HYDROCHLORIDE
9330 I III 9/6/1991 LEIDEL CORP INJECTION MOLDED PRODUCTS
9331 I II 9/5/1991 GEN THERAPEUTICA VERTRIEBS GMBH FACILITIES AND OPERATING PROCEDURES IN
AND CO BAD ZWISCHENAHN,GERMANY
9332 I II 9/5/1991 BOEHRINGER INGELHEIM PHARMA KG PILOCARPINE HYDROCHLORIDE
9333 I II 9/5/1991 TECHNOCHEMIE GMBH METHOXYCARBONYL-METHYLENE-TRIPHENYL-
PHOSPHORANE"YLID-ESTER"
9334 I III 9/10/1991 HELVOET PHARMA MARYLAND RUBBER FORMULATION B5310-55 BLACK
Page 295
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9335 I II 9/6/1991 ISOCHEM SA 1,4-DITHIA-7-AZASPIRO[4,4]NONANE-8-
(S)CARBOXYLIC ACID-HYDROBR
9336 I II 9/6/1991 LABORATOIRE AGUETTANT PARC APOMORPHINE
SCIENTIFIC TONY GARNIER RUE
ALEXANDER FLEMMING
9337 I III 9/9/1991 HELVOET PHARMA MARYLAND RUBBER FORMULATION B5011-55 BLACK
9338 I II 9/6/1991 LABORATOIRE AGUETTANT PARC FACILITIES AND PROCEDURES FOR THE G. OF
SCIENTIFIC TONY GARNIER RUE APOMORPHINE, FRANCE
ALEXANDER FLEMMING
9339 A IV 9/10/1991 HENRY H OTTENS MANUFACTURING CO SPRAY DRIED ARTIFICIAL VANILLA CREAM
INC FLAVOR S-208,PENNSYLVANI
9340 I IV 9/10/1991 HENRY H OTTENS MANUFACTURING CO POWDERED NATURAL/ARTIFICAL LEMON JUICE
INC FLAVOR #4968 IN PENNSY
9341 I IV 9/10/1991 HENRY H OTTENS MANUFACTURING CO ARTIFICIAL CHERRY RASPBERRY FLAVOR
INC #5091(ALCOHOL FREE)
9342 I II 8/31/1991 FINE CHEMICALS CORP TRIAZOLAM
9343 I II 8/31/1991 FINE CHEMICALS CORP ALPRAZOLAM
9344 I II 9/16/1991 WHATMAN SODIUM CELLULOSE PHOSPHATE
9345 I III 9/18/1991 FUJI PHOTO FILM CO LTD ASTRO PORE PSM CARTRIDGE
9346 I I 9/5/1991 TAIHO PHARMACEUTICAL CO INC FACILITIES AND PROCEDURES FOR
TAZOBACTAM BULK DRUG
9347 I II 9/19/1991 GUJARAT DRUGS AND CHEMICALS LTD FACILITIES, PERSONNEL AND GENERAL
OPERATING PROCEDURES - INDIA
9348 I II 9/19/1991 INFAR INDIA LTD METOCLOPRAMIDE AND ITS RELATED
HYDROCHLORIDE SALT
9349 I II 9/19/1991 AMUCHINA SPA FACILITY FOR THE G. OF AMUCHINA 10% IN
CASELLA(GENOVA) ITALY
9350 I IV 9/18/1991 GATTEFOSSE SAS SUPPOCIRE P SERIES EXCIPIENTS
9351 I II 9/6/1991 BOEHRINGER INGELHEIM PHARMA HYOSCYAMINE SULFATE
GMBH AND CO KG
9352 I II 9/16/1991 GANES CHEMICALS INC PENNSVILLE FELBAMATE
9353 I III 9/18/1991 PUBLIC STOCK CORPORATION OYJ NASAL ADAPTER
9354 I III 9/24/1991 HELVOET PHARMA MARYLAND RUBBER FORMULATION N4003-45 RED
9355 I II 9/27/1991 AMICON DIV WR GRACE AND CO AMICON MATRIX SILICA REVERSED PHASE
CHROMATOGRAPHY MEDIA
9356 I II 10/1/1991 SHANGHAI BIOCHEMICAL AND HUMAN CHORIONIC GONADOTROPIN
PHARMACEUTICAL LABORATORIES
9357 I I 9/20/1991 HIGHLAND PACKAGING CO FACILITY IN BRANCHBURG TOWNSHIP, NEW
JERSEY
9358 I II 9/26/1991 DAINIPPON INK AND CHEMICAL INC PANTETHINE
BIOCHEMICAL DIV
9359 I II 9/23/1991 SA AJINOMOTO OMNICHEM NV 6-MERCAPTOPURINE
9360 I II 10/2/1991 CHINA CHEMICAL SYNTHESIS NORFLOXACIN
INDUSTRIAL CO LTD
9361 I III 9/25/1991 UNITED STATES COTTON INC 100% COTTON COIL
Page 296
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9362 A IV 8/27/1991 ITACEL FARMOQUIMICA LTDA SOLUTAB CROSCARMELLOSE SODIUM
9363 I II 9/7/1991 YUKI GOSEI KOGYO CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF ISONAZID IN JOBAN
FACTORY, IWAKI-CITY, FUKUSHIMA
PREFECTURE, JAPAN.
9364 I II 10/1/1991 EGIS PHARMACEUTICALS PRIVATE LTD PROCHLORPERAZINE MALEATE
9365 A II 9/30/1991 TAKEDA PHARMACEUTICAL CO LTD TAP-144-SR (3M) (22.5MG.)
9366 I II 10/2/1991 PENICK CORP CODEINE
9367 I II 10/3/1991 REGIS CHEMICAL CO STERILE FINISHED PRODUCTS AND STERILE
PROCESSING OPERATIONS LOCATED IN
TUSTIN, CA.
9368 I II 10/2/1991 PENICK CORP CODEINE SULFATE
9369 I II 9/30/1991 SUMIKA FINE CHEMICALS CO LTD DOBUTAMINE HYDROCHLORIDE
9370 I III 10/7/1991 HEAT SEAL PACKAGING FOILGUARD #W
9371 I II 10/8/1991 DIOSYNTH BV UROFOLLITROPHIN
9372 I I 10/7/1991 HARIMA FACTORY OF TEIKOKU FACILITIES AND OPERATING PROCEDURES IN
CHEMICAL INDUSTRIES HYOGO, JAPAN
9373 I II 10/7/1991 NAGASE FINE CHEMICALS LTD S-(+)-2-(4`-ISOBUTYLPHENYL) PROPIONIC ACID
(S-(+)-IBUPROFEN
9374 I II 10/4/1991 SYNTEX PHARMACEUTICALS AMIPRILOSE HYDROCHLORIDE
INTERNATIONAL LTD
9375 I II 10/14/1991 RESOLUTION CHEMICALS LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF AZATHIPRINE UPS
9376 A II 10/9/1991 CAMBREX PROFARMACO MILANO SRL ACEBUTOLOL HYDROCHLORIDE
9377 I III 10/8/1991 ALUMINUM CO AMERICA PHAR 9101
9378 I III 10/8/1991 ALUMINUM CO AMERICA PHAR 9100
9379 A III 10/10/1991 JAPAN GLASS INDUSTRY CO LTD AMPOULES, VIALS AND CARTRIDGES
9380 I II 10/18/1991 DIASPA TRADE MARK STRIDES ITALIA DEMECLOCYCLINE HYDROCHLORIDE
SRL
9381 I II 10/2/1991 BLIS TECH CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN FAIRFIELD, NEW JERSEY.
9382 I II 10/23/1991 SANOFI CHIMIE ACEBUTOLOL HYDROCHLORIDE
9383 I II 10/24/1991 TAENAKA KOGYO CO LTD L-TYROSINE
9384 A II 10/24/1991 TAENAKA KOGYO CO LTD L-GLUTAMIC ACID
9385 I IV 10/24/1991 DOW CHEMICAL CO CARBOWAX SENTRY METHOXYPOLYETHYLENE
GLYCOL
9386 I II 10/24/1991 SPECGX LLC DESMOPRESSIN
9387 I II 10/25/1991 WEST GRAND CORP THEOPHYLLINE
9388 I II 10/28/1991 SYNPAC CHEMICALS LTD FACILITIES AND OPERATING PROCEDURES IN
CAMBOIS, ENGLAND
9389 I II 10/16/1991 YONEYAMA YAKUHIN KOGYO CO LTD FACILITIES AND OPERATING PROCEDURES AT
THE MIKUNI PLANT
Page 297
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9390 I III 10/25/1991 BASELL POLIOLEFINE ITALIA SPA LUPOLEN 6031 M
9391 I III 9/24/1991 BASF AKTIENGESELLSCHAFT NOVOLEN 3204 PCX
9392 I III 9/24/1991 BASF AKTIENGESELLSCHAFT NOVOLEN 3200 H
9393 I II 10/18/1991 DAICEL CHEMICAL INDUSTRIES LTD N-{1-(S)-ETHOXYCARBONYL-3-PHENYLPROPYL}-
(S)-ALANINE
9394 I III 10/21/1991 CREST FLEXIBLE PACKAGING LTD SACCHET OVERWRAP
9395 I III 10/21/1991 CREST FLEXIBLE PACKAGING LTD BLISTER PACK PEELABLE LIDDING MATERIAL
9396 I II 10/18/1991 TORAY INDUSTRIES INC FACILITIES FOR THE G. OF BERAPROST SODIUM
IN NAGOYA, JAPAN
9397 I II 11/5/1991 CHEMAGIS LTD MANUFACTURING SITE FOR PENTOXIFYLLINE G.
IN BEER SHEVA, ISRAEL
9398 I III 11/1/1991 SOCIETE ALSACIENNE D ALUMINUM DRUG PHARMACEUTICAL BLISTER
9399 A II 10/31/1991 JOHNSON MATTHEY INC SUFENTANIL CITRATE (GENERIC)
9400 I II 11/1/1991 MALLADI DRUGS AND PSEUDOEPHEDRINE BASE
PHARMACEUTICALS LTD
9401 A III 11/5/1991 BESPAK DIV CONSORT MEDICAL PLC BESPAK BK 681 VALVE
9402 I II 11/5/1991 BIOKINE TECHNOLOGY LTD FACILITIES FOR THE G. OF
GLUCOSAMINYLMURAMYL PEPTIDES
9403 I IV 10/21/1991 CERESTAR USA INC BETA-CYCLODEXTRIN
9404 I II 10/21/1991 AMERICAN MAIZE PRODUCTS CO FACILITIES AND OPERATING PROCEDURES IN
HAMMOND, INDIANA
9405 I II 11/8/1991 MAY AND BAKER LTD PROMETHAZINE HYDROCHLORIDE
9406 I II 11/14/1991 SIFAVITOR SRL METRONIDAZOLE BENZOATE
9407 I III 11/19/1991 KAITO CHEMICAL INDUSTRY CO LTD PORTION PACK A, B, AND C
9408 A II 11/11/1991 SANDOZ GMBH PYCA.HI (PYRIDINIUM-7-
AMINOCEPHALOSPORANIC ACID HYDROIODIDE)
9409 I III 11/5/1991 ROLLPRINT PACKAGING PRODUCTS INC RPP #36-1054 PACKAGING MATERIAL
Page 299
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9455 I II 12/5/1991 BOEHRINGER MANNHEIM GMBH PRODUCTION PLANT HC-B 4 AND EXTRACTION
PLANT HC-B 10 IN MANNHEIM, GERMANY
9456 I II 12/7/1991 FUJISAWA PHARMACEUTICAL CO LTD FACILITY LOCATED IN NAGOYA, JAPAN
9457 I II 12/10/1991 FUJISAWA PHARMACEUTICAL CO LTD FACILITY LOCATED IN OSAKA, JAPAN
9458 I II 12/13/1991 NORISTAN LTD DICYCLOMINE HYDROCHLORIDE
9459 I II 12/11/1991 UNION QUIMICO FARMACEUTICA SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF CIMETIDINE USP IN
BARCELONA, SPAIN.
9460 I II 12/12/1991 MARION MERRELL DOW RESEARCH FACILITIES LOCATED IN WINNERSH,
AND DEVELOPMENT CENTRE BERKSHIRE, THE UNITED KINGDOM
9461 I II 12/13/1991 MITSUBISHI KASEI CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MIE PREFECTURE, JAPAN.
9462 I II 12/13/1991 BOEHRINGER MANNHEIM GMBH QUININE SULFATE
9463 I II 12/18/1991 MALLINCKRODT CHEMICAL INC CALCITONIN, SALMON
9464 I II 12/12/1991 CAMBRIDGE CHEMICAL INC 2,7-DIMETHYL-FMOC-L-LEUCINE
9465 I II 12/19/1991 DOW CORNING CORP SILASTIC MDF-0108 MEDICAL GRADE TUBING
9466 A III 12/13/1991 SIEGWERK DRUCKFARBEN AG AND CO EPOXY AMINE TWO COMPONENT INKS FOR
KGAA PRINTING POLYESTER FILMS
9467 I III 12/17/1991 TECH SEAL PRODUCTS INC LINER MATERIALS AND TAMPER EVIDENCE
INNERSEALS
9468 I II 12/18/1991 ROCHE DIAGNOSTICS GMBH CYTOSINE - ARABINOFURANOSIDE
9469 I II 12/19/1991 SCIENTIFIC PROTEIN LABORATORIES DERMATAN SULFATE
INC
9470 I II 12/26/1991 KYORIN PHARMACEUTICAL CO LTD FACILITIES FOR THE G. OF FLEROXACIN BULK
DRUG SUBSTANCE AT THE OKAYA PLANT IN
NAGANO, JAPAN
9471 I II 12/20/1991 LIPHA SAS FACILITIES AND PROCEDURES IN
HERTFORDSHIRE AND MIDDLESEX, ENGLAND
9472 A II 12/23/1991 SANOFI CHIMIE HEPARIN SODIUM
9473 I IV 12/19/1991 MITSUBISHI KASEI CORP SUCROSE STEARATE "RYOTO"
9474 I II 12/26/1991 CYGNUS INC FENTANYL TRANSDERMAL SYSTEM (FENTANYL
TS)
9475 I II 1/2/1992 APPLIED ANALYTICAL INDUSTRIES INC SUCROSE OCTASULFATE, AMMONIUM SALT
9476 I II 12/31/1991 DM GRAHAM LABORATORIES INC ACETAMINOPHEN CONTROLLED-RELEASE
BEADS 325 MG.
9477 A II 11/25/1991 PIERRE FABRE MEDICAMENT VINORELBINE TARTRATE
9478 I II 12/31/1991 ASTELLAS PHARMA INC CEFIXIME
9479 I II 12/16/1991 ASTELLAS PHARMA INC 7 ACA-A48
9480 I II 12/16/1991 FUJISAWA PHARMACEUTICAL CO LTD STERILE CEFAZOLIN SODIUM
9481 I II 12/17/1991 PHARMECO LABORATORIES INC LEVOBUNOLOL HYDROCHLORIDE
9482 A II 1/8/1992 MEDICHEM SA LEVOBUNOLOL HYDROCHLORIDE
9483 I II 1/10/1992 BIOCHIMICA OPOS 2 SPA DOBUTAMINE HYDROCHLORIDE, BULK, NON
STERILE PYROGEN FREE
Page 300
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9484 I II 1/6/1992 BURROUGHS WELLCOME INDIA LTD PSEUDOEPHEDRINE HYDROCHLORIDE
9485 I II 1/3/1992 EVONIK CORP GLYCYL-L-TYROSINE DIHYDRATE
9486 A II 1/3/1992 EVONIK CORP L-ALANYL-L-GLUTAMINE
9487 I II 1/3/1992 EVONIK CORP GLYCYL-L-GLUTAMINE MONOHYDRATE
9488 I II 1/6/1992 YONEYAMA YAKUHIN KOGYO CO LTD L-LEUCINE
9489 I II 1/7/1992 5N PLUS LUBECK GMBH BISMUTH CITRATE
9490 I II 12/6/1991 SHANGHAI ZHONGXI PHARMACEUTICAL HYDROXYCHLOROQUINE SULFATE
CO LTD
9491 I II 12/31/1991 CHONGQING PHARMACEUTICAL AMRINONE
RESEARCH INSTITUTE CO LTD
9492 I IV 1/7/1992 SHAW MUDGE AND CO FRAGRANCE FORMULATIONS M-4600 AND U-
8571
9493 A II 1/8/1992 LUSOCHIMICA SPA NICARDIPINE HYDROCHLORIDE
9494 I I 12/30/1991 EMS DOTTIKON AG MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN DOTTIKON, SWITZERLAND.
9495 I II 1/14/1992 GIST-BROCADES NV 6-AMINOPENICILLANIC ACID (6-APA)
PHARMACEUTICALS
9496 I II 1/10/1992 SYNTHELABO RECHERCHE ALPIDEM
9497 I II 12/11/1991 RENKER GMBH AND CO KG PET-FILM 15U, ONE SIDE ALUMINIZED, REVERSE
SIDE YELLOW OCHER COLOR PRINT
9498 I I 1/3/1992 OGDDEN BIOSERVICES CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
9499 I III 12/20/1991 WEST CO INC FASPAK ANTIBIOTIC CONTAINERS
9500 I II 1/7/1992 FLEXCON CO MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SPENCER, MASSACHUSETTS.
Page 304
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9595 I II 3/13/1992 BOEHRINGER INGELHEIM MANUFACTURING SITE, FACILITIES,
PHARMACEUTICALS INC PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN RIDGEFIELD, CONNECTICUT.
9596 I II 2/28/1992 STREM CHEMICALS INC GALLIUM NITRATE HYDRATE
9597 I I 3/16/1992 SYNTEX LABS FACILITIES AND CONTROLS IN BUENOS AIRES,
ARGENTINA
9598 I I 4/17/1992 SAITAMA DAIICHI PHARMACEUTICAL FACITLITIES AND PROCEDURES IN ONUMA,
CO., LTD HANYU-SHI, SAITAMA PREFECTURE, JAPAN
9599 I II 3/4/1992 TRIDENT ORGANICS PRIVATE LTD ASTEMIZOLE INTERMEDIATES
9600 A IV 3/10/1992 LIPOID GMBH LIPOID S 75
9601 A II 3/26/1992 JOHNSON MATTHEY INC CISPLATIN
9602 I III 3/19/1992 SILGAN PLASTICS CORP PLASTIC TUBES
9603 I II 3/18/1992 TOMITA PHARMACEUTICAL CO LTD FERRIC AMMONIUM CITRATE, BROWN
9604 I II 3/24/1992 CARLBIOTECH LTD AS OXYTOCIN
9605 A IV 3/23/1992 LIPOID GMBH LIPOID S 100
9606 I II 3/25/1992 WACKER CHEMIE GMBH 2-(2-METHOXYETHOXY) ACETALDEHYDE
DIMETHYL ACETAL
9607 A III 3/16/1992 3M DRUG DELIVERY SYSTEMS 9720 POLYETHYLENE FILM
9608 I III 3/20/1992 ROLLPRINT PACKAGING PRODUCTS INC RPP # 26-1054
9609 I III 3/6/1992 DSM THERMOPLASTIC ELASTOMERS, SARLINK 2400 SERIES OF THERMOPLASTICS
INC. ELASTOMERS
9610 I III 2/13/1992 RHONE POULENC INC COLLOID 999
9611 I IV 3/16/1992 METSA SPECIALTY CHEMICALS BV SODIUM CARBOXYMETHYLCELLULOSE
9612 I III 3/5/1992 AMPACET CORP 11171-101 WHITE PE/MB
9613 I II 5/15/1991 PROCYTE CORP GLY-HIS-LYS TRIPEPTIDE COPPER CHELATE
9614 I II 12/14/1988 BACHEM FEINCHEMIKALIEN AG GLY-HIS-LYS TRIPEPTIDE COPPER CHELATE
9615 I II 10/1/1990 HAMARI CHEMICALS LTD GLY-HIS-LYS TRIPEPTIDE COPPER CHELATE
9616 I II 5/7/1969 PHARMACIA PL BIOCHEMICALS INC POLYCYTIDYLIC ACID (POLY 1)
9617 I II 5/7/1969 PHARMACIA PL BIOCHEMICALS INC POLYCYTIDYLIC ACID (POLY C)
9618 I II 10/19/1990 CARLBIOTECH LTD AS (D-ALA1)-PEPTIDE-T AMIDE
9619 A II 9/30/1992 CAMBREX PROFARMACO MILANO SRL CYSTEAMINE BITARTRATE
9620 I II 3/16/1992 SYNTEX SA HEPARIN SODIUM
9621 I II 4/2/1992 PLAISTOW LTD PROPIRAM FUMERATE
9622 I II 3/30/1992 HAMARI CHEMICALS LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN OSAKA, JAPAN.
9623 I III 4/1/1992 TUREX INC PACKAGING MATERIAL
9624 I II 3/30/1992 HAMARI CHEMICALS LTD (3S)-1,2,3,4-TETRAHYDRO-3-
ISOQUINOLINECARBOXYLIC ACID BENZYL
ESTER P-TOLUENESULFONIC ACID SALT "THIQ-
B"
9625 I II 4/1/1992 NEWPORT PHARMACEUTICALS PENTAMIDINE ISETHIONATE
IRELAND
Page 305
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9626 I IV 3/30/1992 BIO-RAD LABORATORIES MACRO-PREP S STRONG CATION EXCHANGE
SUPPORT
9627 A IV 3/30/1992 BIO-RAD LABORATORIES MACRO-PREP CM WEAK CATION EXCHANGE
SUPPORT
9628 I IV 3/30/1992 BIO-RAD LABORATORIES MACRO-PREP Q STRONG ANION EXCHAGE
SUPPORT
9629 I II 4/1/1992 FUJISAWA PHARMACEUTICAL CO LTD FACILITY IN TOYOMA, JAPAN
9630 I III 3/24/1992 COLOR CONVERTING INDUSTRIES PRINTING INK FOR PACKAGING MATERIALS
9631 I II 3/30/1992 PT SINKONA INDONESIA LESTARI MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CIATER, INDONESIA.
9632 I II 3/30/1992 PT SINKONA INDONESIA LESTARI QUINIDINE SULFATE
9633 I III 3/23/1992 ROLLPRINT PACKAGING PRODUCTS INC RPP #26-1066
9708 I III 6/3/1992 HELVOET PHARMA MARYLAND LZ 519 RUBBER CLOSURE FORMULATION
9709 I II 6/4/1992 CIBA GEIGY CORP PHARMACEUTICAL NAPHAZOLINE HYDROCHLORIDE
DIV
9710 I II 6/4/1992 HOECHST-ROUSSEL HP 290 MANUFACTURE, ISOLATION,
PHARMACEUTICALS INC PURIFICATION AND TESTING
9711 I II 5/29/1992 NIPPON JUNRYO CHEMICALS CO LTD 5-AMINOSALICYLIC ACID
9712 I II 6/2/1992 HOUBA INC ZIDOVUDINE
9713 I II 6/5/1992 SUMIKA FINE CHEMICALS CO LTD FACILITIES AND PROCEDURES AT THE GIFU
PLANT, JAPAN
9714 I II 6/5/1992 SUMIKA FINE CHEMICALS CO LTD FACILITIES AND PROCEDURES AT THE OKAYAMA
PLANT IN JAPAN
9715 I V 6/4/1992 ASTRA HASSLE AB STUDIES CONDUCTED WITH ALMOKALANT
9716 A II 6/8/1992 CU CHEMIE UETIKON GMBH 4-PHENYLBUTYRIC ACID SODIUM SALT
9717 I II 6/5/1992 AVANTI POLAR LIPIDS INC 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-
[PHOSPHO-RAC-(1-GLYCEROL)]
9718 I II 5/19/1992 QUIMICA SINTETICA SA KETOCONAZOLE
9720 I III 1/20/1992 SWIFT ADHESIVES DIV REICHHOLD 81463 ADHESIVE
CHEMICALS INC
9721 I II 6/12/1992 CHISSO CORP CELLUFINE GCL-25 AND GCL-90 GEL FILTRATION
CHROMATOGRAPHY MEDIA
9722 I II 6/12/1992 CHISSO CORP CELLUFINE GCL-1000 CHROMATOGRAPHY
MEDIA
Page 309
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9723 I II 6/12/1992 CHISSO CORP CELLUFINE GCL-300 CHROMATOGRAPHY MEDIA
Page 312
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9808 I I 8/13/1992 DR FRANZ KOHLER CHEMIE GMBH FACILITIES, PERSONNEL AND GENERAL
OPERATING PROCEDURES LOCATED IN
ALSBACK-HAHNLEIN, FEDERAL REPUBLIC OF
GERMANY
9809 I II 8/3/1992 KV PHARMACEUTICAL CO CETIRIZINE
HYDROCHLORIDE/PSEUDOEPHEDRINE
HYDROCHLORIDE EXTENDED-RELEASE
CAPSULES, 10MG/240MG
9810 I II 8/14/1992 ELEOS INC NUMBER OL(1)P53
9811 I II 8/5/1992 GRUNENTHAL GMBH TRAMADOL HYDROCHLORIDE
9812 I I 8/5/1992 GRUENTHAL FACILITY FOR THE MANUFACTURE OF
TRAMADOL HYDROCHLORIDE IN AACHEN,
FEDERAL REPUBLIC OF GERMANY
9813 I III 8/3/1992 BASELL POLIOLEFINE ITALIA SPA LUPOLEN 1840 D
9814 I II 8/10/1992 NIPPON KAYAKU CO LTD BOC-AHPBA-OH, INTERMEDIATE OF DRUG
SUBSTANCE
9815 I II 8/25/1992 SIANG TA PHARMACEUTICAL CO LTD SODIUM STARCH GLYCOLATE
9816 I II 8/14/1992 SYNTHELABO PHARMACIE PRECLINICAL ANIMAL STUDIES FOR TRIPTOSINE
Page 313
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9835 I I 8/15/1992 SYNCHEM CHEMICALS PVT LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ANKLESHWAR GUJARAT,
INDIA.
9836 I II 8/24/1992 MEIJI SEIKA KAISHA LTD FACILITY AND PROCEDURES AT THE KITAKAMI
PLANT.
9837 I II 8/20/1992 RESOLUTION CHEMICALS LTD BACLOFEN
9838 I II 8/15/1992 SYNCHEM CHEMICALS PVT LTD METOPROLOL TARTRATE
9839 A II 7/27/1992 FDC LTD TIMOLOL MALEATE USP
9840 I II 8/21/1992 WYCKOFF CHEMICAL CO INC FLURBIPROFEN
9841 A II 8/31/1992 3M DRUG DELIVERY SYSTEMS ESTRADIOL TRANSDERMAL DRUG DELIVERY
SYSTEM
9842 I IV 7/28/1992 ROBERTET FLAVORS INC SPRAY DRIED ARTIFICIAL CHERRY FLAVOR
9843 I II 8/31/1992 WACKER CHEMIE GMBH FACILITIES AND PROCEDURES IN
BURGHAUSEN, GERMANY
9844 A II 8/28/1992 KONGO CHEMICAL CO LTD CARBINOXAMINE MALEATE
9845 I II 8/31/1992 CELSUS LABORATORIES INC HEPARIN PEPTIDOGLYCAN
9846 I III 8/28/1992 BOSTIK INC HOT MELT ADHESIVE 235-334
9847 I II 8/28/1992 BRISTOL MYERS SQUIBB CO TRIAMCINOLONE HEXACETONIDE
9848 I II 9/3/1992 PENTAPHARM LTD BASLE PEFABLOC SC
9849 I II 9/1/1992 BACHEM INC MSI-78
9850 I II 9/4/1992 DSM PHARMA CHEMICALS SOUTH HYDROXYUREA
HAVEN INC
9851 I III 8/24/1992 BASELL POLIOLEFINE ITALIA SPA LUPOLEN 5261 ZQ 445
9852 I II 8/31/1992 ANDRULIS RESEARCH CORP CIS-PLATIN (NSC-119875)
9853 I II 9/1/1992 SMITHKLINE BEECHAM MANUFACTURING SITE, FACILITIES, PESONNEL,
PHARMACEUTICALS AND GENERAL OPERATING PROCEDURES IN
WEST SUSSEX, ENGLAND.
9854 A II 9/1/1992 ASPEN OSS BV ROCURONIUM BROMIDE
9855 I I 9/2/1992 CHANTAL PHARMACEUTICAL CORP FACILITIES AND PROCEDURES IN
KAISERSLAUTERN, GERMANY
9856 I III 9/2/1992 3M PHARMACEUTICALS #MSP 082592P DOUBLE COATED
POLYETHYLENE TAPE
9857 I III 9/2/1992 3M DRUG DELIVERY SYSTEMS #MSP 082492P POLYETHYLENE TAPE
9858 I III 9/2/1992 3M DRUG DELIVERY SYSTEMS 3M COTRAN 9764 FOAM TAPE
9859 A V 9/3/1992 INTERNATIONAL PHARMACEUTICAL TOXICOLOGY AND PHARMACOKINETICS DATA
AEROSOL CONSORTIUM TOXICOLOGY ON THE HYDROFLUOROALKANE HFA-134A.
TESTING
9860 I III 9/11/1992 JL CLARK DIV ATLAS TUBE COLLAPSIBLE ALUMINUM TUBES
9861 I II 9/8/1992 BAYER AG BAY Y 3118 DRUG SUBSTANCE
9862 A III 9/3/1992 WALTER DRAKE INC THERORMED PLASTIC STRIPS
9863 I III 8/31/1992 FINDLEY ADHESIVES INC HOT MELT ADHESIVE 694-373
9864 I III 9/3/1992 PRENT CORP 24 UNIT RU-TUSS DE ARRAY
9865 I II 9/14/1992 JAPAN ENERGY CORP KNI-272
Page 314
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9866 I II 9/14/1992 JAPAN ENERGY CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SAITAMA, JAPAN.
9867 I II 8/8/1992 JOHNSON MATTHEY INC BAHNH (CYTOGEN LINKER)
9868 A III 9/9/1992 SGD SA AMBER GLASS III CONTAINERS
9869 A III 9/8/1992 BERRY GLOBAL THERMOPLASTIC CLOSURES & SPECIALTY
ITEMS
9870 I II 9/7/1992 FERMTEC PROCHIM SA METHACYCYLINE HYDROCHLORIDE
9871 I II 9/11/1992 UNION QUIMICO FARMACEUTICA SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BARCELONA, SPAIN.
9872 I III 9/18/1992 KOLACK AG INTERNAL COATING 3123
9873 I II 9/14/1992 ROHNER AG PHENAZOPYRIDIINE HYDROCHLORIDE
9874 I II 9/15/1992 PHARMAZELL GMBH L-LYSINE-N-ACETYLCYSTEINATE
9875 I II 9/24/1992 NIPPON KAYAKU CO LTD AUREOBASIDIN A
9876 I II 9/22/1992 ACS DOBFAR SPA O-FORMYL CEFAMANDOLE ACETONITRILE
SOLVATE
9877 I III 9/29/1992 SPARTECH POLYCOM D19971 WHITE POLYPROPYLENE
CONCENTRATE
9878 A III 9/25/1992 NOVA CHEMICALS CORP POLYETHYLENE RESINS
9879 I I 9/4/1992 SOLVAY FLUOR AND DERIVATE GMBH MANUFACTURING SITE, FACLITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF 1,1,2,3,3,3-
HEPTAFLUOROPROPANE IN FRANKFURT,
GERMANY.
9880 I II 9/25/1992 GANES CHEMICALS INC PENNSVILLE GEIBROZIL
9881 I II 9/18/1992 SCICLONE PHARMACEUTICALS INC THYMOSIN ALPHA 1 INJECTION FINAL DOSAGE
FORM
9882 I IV 9/28/1992 INTERCAPS SPOL SRO EMPTY HARD GELATIN CAPSULES
9883 I II 9/25/1992 VIOBIN CORP VIOKASE
9884 I III 10/1/1992 3M PHARMACEUTICALS #MSP 081792P POLYOLEFIN FOAM TAPE
9885 I III 10/1/1992 3M PHARMACEUTICALS #9751 POLYOLEFIN FOAM TAPE
9886 I II 4/15/1987 DAIICHI SANKYO PROPHARMA CO LTD CS-807 CEFPODOXIME PROXETIL DRUG
SUBSTANCE
9887 I II 9/3/1982 SANKYO CO LTD CEFMETAZOLE (FREE ACID)
9888 I II 10/2/1992 HUHTAMAKI OY LEIRAS DOBUTAMINE HYDROCHLORIDE
PHARMACEUTICALS
9889 I II 9/21/1992 ELANCO QUIMICA LIMITADA CEPHALEXIN DISOLVATE
9890 I II 9/30/1992 LIFE TECHNOLOGIES INC CHO-S-SFM AND CHO-S-SFMII
9891 I II 9/19/1992 FREEDOM CHEMICAL DIAMALT GMBH METOPROLOL TARTRATE
9892 I II 9/30/1992 LIFE TECHNOLOGIES INC HYBRIDOMA SFM
9893 I II 9/30/1992 LIFE TECHNOLOGIES INC SF-900 SERUM-FREE INSECT CELL CULTURE
MEDIUM
9894 I II 8/21/1992 OTSUKA PHARMACEUTICAL CO LTD FACILITIES AND OPERATING PROCEDURES AT
THE SAGA FACTORY, JAPAN
Page 315
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9895 I II 9/25/1992 ATI POTASSIUM DICHROMATE, POTASSIUM
HYDROFIDE, UREA (STERILIZATION PROCESS
INDICATORS
9896 I II 10/5/1992 OTSUKA PHARMACEUTICAL CO LTD COMMERCIAL BULK PLANT OF SECOND
TOKUSHIMA FACTORY IN TOKUSHIMA, JAPAN
9897 I II 9/30/1992 CHEMICAL PHARMACEUTICAL FACILITY FOR THE MANUFACTURE OF
RESEARCH INSTITUTE NIHFI LTD GALANTHAMINE HYDROBROMIDE IN SOFIA,
BULGARIA
9898 I II 10/5/1992 STAVO INDUSTRIES INC PHARMACEUTICAL GRADE DEPTH FILTER
MEDIA
9899 A II 10/5/1992 SYN-TECH CHEM AND PHARM CO LTD DICLOFENAC SODIUM USP
9900 I III 10/8/1992 3M DRUG DELIVERY SYSTEMS #1779 POLYOLEFIN FOAM TAPE
9901 I III 10/5/1992 WEST PENN PLASTIC INC 25 TABLET DISPENSER
9902 I III 10/5/1992 WEST PENN PLASTIC INC DOSAGE CUP PP FOR TRIAMINIC LIQUIDS
9903 I III 10/5/1992 WEST PENN PLASTIC INC 28 TABLET DISPENSER
9904 I III 10/5/1992 WEST PENN PLASTIC INC 21 TABLET DISPENSER
9905 I III 10/1/1992 SGD SA TITAN 300 TREATED CONTAINERS
9906 A II 10/9/1992 NOVARTIS PHARMA AG PENTETREOTIDE
9907 I II 10/14/1992 ASAHI CHEMICAL INDUSTRY CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF ORACIL IN NOBEOKA CITY,
JAPAN.
9908 I II 10/14/1992 ASAHI KASEI FINECHEM CO LTD URACIL
9909 I III 10/14/1992 TENAX CORP PACKAGING MATERIALS
9910 I II 10/13/1992 LAPORTE INDUSTRIES LTD LAPONITE D, DS, XLG, XLS, AND DF PRODUCTS
9911 I II 9/24/1992 PCAS BISMUTH SUBSALICYLATE AND SODIUM
BICARBONATE 2 PER THOUSAND
9912 I II 10/16/1992 3M PHARMACEUTICALS PERFLUORODICHLOROOCTANE
9913 I II 9/29/1992 HYDRO MED SCIENCES HISTRELIN (LHRH AGONIST) IMPLANTS
9914 I II 10/8/1992 VALOIS SAS MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN LE VAUDREUIL, FRANCE.
9915 A II 10/21/1992 CORDEN PHARMA BRUSSELS SA EPTIFIBATIDE (BULK)
9916 I II 10/12/1992 IPCA LABORATORIES LTD PYRANTEL TARTRATE
9917 I II 10/21/1992 MALLINCKRODT INC OCTREOSCAN REACTION VIAL, PENETREOTIDE
LYPHOLIZED
9918 A II 10/21/1992 CURIUM US LLC OCTREOSCAN REACTION VIAL
9919 A II 10/21/1992 CURIUM US LLC INDIUM IN-111 CHLORIDE STERILE SOLUTION
9920 I III 9/28/1992 ROLLPRINT PACKAGING PRODUCTS INC RPP #31-1003 PACKAGING MATERIAL
9921 I III 10/23/1992 HAENDLER AND NATERMANN GMBH FORMABLE FILM FOIL COMBINATIONS
9922 I II 9/24/1992 PCAS FACILITY IN LA VOULTE SUR RHONE, FRANCE
9923 A II 10/23/1992 SEKISUI MEDICAL CO LTD N-ACETYL-DL-TRYPTOPHAN
9924 I III 10/23/1992 ROLLPRINT PACKAGING PRODUCTS INC RPP #26-1072 PACKAGING MATERIAL
Page 316
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9925 A II 10/27/1992 TEVA PHARMACEUTICAL INDUSTRIES VECURONIUM BROMIDE
LTD
9926 I II 10/28/1992 E BEGEROW GMBH AND CO FILTRATION MEDIA FOR PURIFICATION OF
PHARMACEUTICAL PRODUCTS
9927 I II 10/27/1992 ERREGIERRE SPA LABETALOL HYDROCHLORIDE
9928 I II 10/23/1992 LIFE TECHNOLOGIES INC SF-900 II SFM (OPTIMIZED SERUM-FREE
MEDIUM FOR INSECT CELL CULTURE,
COMPLETE)
9929 I II 10/24/1992 CARACO PHARMACEUTICAL FACILITY IN DETROIT, MICHIGAN.
LABORATORIES LTD
9930 I II 10/30/1992 SANDOZ PHARMACEUTICALS CORP DIV SDZ PSC 833
SANDOZ INC
9931 I II 11/2/1992 SIGMA F AND D DIV LTD TESTOSTERONE
9932 A IV 10/28/1992 NIPPON SURFACTANT INDUSTRIES CO HCO-60
LTD
9933 I II 11/2/1992 MILLIPORE CORP MILLIPAK 20 FILTER UNIT
9934 I II 10/30/1992 FUKUZYU PHARMACEUTICAL CO LTD NAPHAZOLINE HYDROCHLORIDE
9935 I II 10/29/1992 CHONGQING NO. 5 PHARM. FACTORY METHAZOLAMIDE
9936 I II 10/28/1992 EASTMAN CHEMICAL CO MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF HOT MELT ADHESIVES IN
LONGVIEW, TEXAS.
9937 I III 11/3/1992 SHIN ETSU CHEMICAL IND CO LTD X-70-201 FLUOROSILICONE RELEASE MATERIAL
9938 A III 11/2/1992 TUSA SA ALUMINUM TUBES PACKAGING MATERIAL
9939 I II 11/2/1992 SANOFI SYNTHELABO INC NADROPARIN CALCIUM
9940 I II 10/28/1992 BIORAD CHEMICAL DIV MACRO-PREP HIGH S STRONG CATION
EXCHANGE SUPPORT
9941 A II 10/28/1992 BIO-RAD LABORATORIES LIFE SCIENCE MACRO-PREP HIGH Q STRONG ANION
GROUP EXCHANGE SUPPORT
9942 I II 11/6/1992 PCAS MOEXIPRIL HYDROCHLORIDE
9943 I III 10/13/1992 BASF AKTIENGESELLSCHAFT SICOLEN BROWN 32-1315
9944 I III 10/13/1992 BASF AKTIENGESELLSCHAFT SICOLEN BLUE 65-0475
9945 I III 10/13/1992 BASF AKTIENGESELLSCHAFT SICOLEN BLUE 66-0185
9946 I III 10/13/1992 BASF AKTIENGESELLSCHAFT SICOLEN BROWN 23-1195
9947 I III 10/13/1992 BASF AKTIENGESELLSCHAFT SICOLEN BROWN 32-1855
9948 A III 10/12/1992 INEOS STYROLUTION EUROPE GMBH NOVODUR R HD 877 M GREY
9949 A III 10/12/1992 INEOS STYROLUTION EUROPE GMBH NOVODUR® HD 877M WHITE
9950 A III 10/13/1992 BASF COLOR SOLUTIONS GERMANY SICOSTYREN WHITE 00-2105 C6
GMBH
9951 A II 11/5/1992 BACHEM AMERICAS INC DESMOPRESSIN ACETATE
9952 I III 11/2/1992 ROLLPRINT PACKAGING PRODUCTS INC RPP #21-1046 PACKAGING MATERIAL
9953 I III 11/6/1992 ROLLPRINT PACKAGING PRODUCTS INC RPP #26-3009 PACKAGING MATERIAL
Page 317
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
9954 I II 11/9/1992 URQUIMA SA FACILITIES AND OPERATING PROCEDURES IN
BARCELONA, SPAIN.
9955 I III 11/6/1992 AMERICAN RENOLIT CORP LAPORTE SOLMED 100 FILM
9956 I IV 10/22/1992 FLAVORS NORTH AMERICA INC #827.052/EN NOR-CAP ARTIFICIAL CINNAMON
FLAVOR AS G. IN NORTHFIELD ILLINOIS.
9957 I II 11/10/1992 GENZYME CORP ACEBUTOLOL HYDROCHLORIDE
9958 I II 11/13/1992 DAIICHI PURE CHEMICALS CO LTD DF-4639 INTERMEDIATE
9959 I II 11/13/1992 DAIICHI PHARMACEUTICAL CO LTD DS-4152 DRUG SUBSTANCE
9960 I II 11/13/1992 DAIICHI PHARMACEUTICAL CO LTD PARENTERAL FORMULATION FACILITY IN
OSAKA, JAPAN.
9961 I IV 11/9/1992 AMERICAN MAIZE PRODUCTS CO MALTODEXTRIN
9962 I II 11/2/1992 BIHOKU FUNKA KOGYO CO LTD PRECIPITATED CALCIUM CARBONATE
9963 I I 11/13/1992 HAMILTON PHARMACEUTICAL LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN HUMACAO, PUERTO RICO.
9964 I II 11/17/1992 HOSPIRA INC PFC EMULSION
9965 I IV 11/16/1992 AMERICAN MAIZE PRODUCTS CO TABLETING STARCH
9966 A II 11/20/1992 TEVA PHARMACEUTICAL INDUSTRIES ETOPOSIDE
LTD
9967 I II 11/19/1992 FARCHEMIA SRL CARBAMAZEPINE
9968 I II 11/13/1992 MALLINCKRODT INC LEVORPHANOL TARTRATE
9969 I II 11/13/1992 ALDRICH CHEMICAL CO INC 1-HEXADECANOL
9970 I II 11/6/1992 FAR RESEARCH INC WAY-125,174 CRUDE
9971 I II 11/19/1992 WHATMAN PAPER LTD DE52/D461 ANION EXCHANGE CELLULOSE
9972 A II 11/25/1992 BACHEM SA 5-AMINOLEVULINIC ACID HYDROCHLORIDE
9973 I II 11/23/1992 PIERRE FABRE MEDICAMENT NAVELBINE FOR INJECTION
PRODUCTION AQUITAINE PHARM
INTERNATIONAL
9974 I I 11/25/1992 LABORATORIO BP SRL MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SIDERNO, ITALY.
9975 I II 11/17/1992 LIPHA SAS FACILITY AND OPERATING PROCEDURES IN
SURESNES, FRANCE.
9976 I II 11/19/1992 BASF CORP UVINUL N539 SG
9977 I II 11/18/1992 ALDRICH CHEMICAL CO INC PERCORTEN PIVALATE
9978 I II 11/20/1992 PARTICLE DYNAMICS INTERNATIONAL DESTAB CALCIUM CARBONATE 95%
LLC
9979 I II 11/19/1992 SIGMA F AND D DIV LTD L-ARGININE HYDROCHLORIDE
9980 I II 11/6/1992 SHIN ETSU CHEMICAL IND CO LTD GADOLINIUM OXIDE
9981 I III 11/30/1992 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMULATION 35004-50 RED
Page 320
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 1/12/1993 RECORDATI INDUSTRIA CHIMICA E ACYCLOVIR
FARMACEUTICA SPA
### I II 1/13/1993 NORDIC SYNTHESIS AB KETOPROFEN
### A II 1/19/1993 URQUIMA SA GLIPIZIDE
### A III 1/8/1993 TICONA LLC CELANEX POLYBUTYLENE TEREPHTHALATE
### I II 1/21/1993 ARCHIMICA SPA FACILITY IN ORIGGIO (VARESE), ITALY
### A III 2/12/1993 LANXESS CORP POCAN B1501 NATURAL
### I III 1/19/1993 ABSORBENT COTTON CO COTTON AND RAYLON COILER
### I III 1/18/1993 GETTIG PHARMACEUTICAL GETTIG BLUNT ASSEMBLY
INSTRUMENT CO
### I II 12/9/1992 DIOSYNTH BV HEPARIN SODIUM
### I III 1/20/1993 ROLLPRINT PACKAGING PRODUCTS INC RPP #26-1010B
### I II 1/21/1993 PFC ITALIANA SRL DIV ALFA CHEMICALS TERAZOSIN HYDROCHLORIDE
ITALIANA
### I II 1/25/1993 GLAXO WELLCOME INC MANUFACTURING PRODUCTION FACILITY IN
TORONTO, CANADA
### I II 1/25/1993 ASAHI GLASS CO LTD MANUFACTURING FACILITIES IN HIRAKATA CITY,
OSAKA, JAPAN
### I II 1/25/1993 ASAHI GLASS CO LTD RO 09-1168
### A II 1/29/1993 COPPERHEAD INVESTMENTS INC SDM-71 NITROGLYCERIN TRANSDERMAL PATCH
Page 321
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I V 12/18/1986 ACS DOBFAR SPA STERILE FINISHED PRODUCTS AND STERILE
PROCESSING OPERATIONS AT THE VIALE
ADDETTA PLANT IN MILANO, ITALY
### A V 8/27/1991 ACS DOBFAR SPA STERILE FINISHED PRODUCTS AND STERILE
PROCESSING OPERATIONS
### I II 8/27/1991 ACS DOBFAR SPA FACILITY AND OPERATING PROCEDURES IN VIA
MARZABOTTO, VIMERCATE, MILANO, ITALY
(PREVIOUSLY AN ANTIBIOTIC FILE)
### I I 2/15/1993 CASCADE BIOCHEM LTD MANUFACTURING FACILITY IN READING,
BERKSHIRE, ENGLAND
### I II 2/15/1993 CASCADE BIOCHEM LTD LEUKOTRIENE D4 IN ETHANOL
### A III 1/26/1993 SHIOTANI GLASS CO LTD AMPULES, VIALS AND CARTRIDGES
### A III 2/8/1993 DAIKYO SEIKO LTD PACKAGING MATERIALS
### I IV 2/10/1993 UNGERER AND CO ARTIFICIAL FRUIT FLAVOR #25288
### I II 11/30/1992 KYOWA HAKKO KOGYO CO LTD URACIL
### I II 2/5/1993 DHP LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN POWYS, THE UNITED
KINGDOM
### I II 2/10/1993 MEGA BLOW MOULDING LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MISSISSAUGA, ONTARIO,
CANADA
### I II 4/11/1991 PHARMACIA AND UPJOHN ERYTHROMYCIN ENTERIC-COATED TABLETS
### A II 2/10/1993 INDENA SPA COLCHICINE USP
### I II 1/29/1993 AJINOMOTO USA INC M-HES
### I II 2/10/1993 SIGMA F AND D DIV LTD HEPES, SODIUM SALT (N-2-
HYDROXYETHYLPIPERAZINE-N'-2-
ETHANESULFONIC ACID)
### I IV 2/11/1993 QP CORP SODIUM HYALURONATE
### I III 2/18/1993 SABIC PETROCHEMICALS BV SABIC LDPE 2100TN00
### I III 2/18/1993 SABIC PETROCHEMICALS BV SABIC LDPE 2200TC00
### I III 2/18/1993 SABIC PETROCHEMICALS BV SABIC LDPE 2200TC12
### A III 2/12/1993 NIPRO PHARMAPACKAGING AMERICAS TUBING GLASS CONTAINERS
CORP
### I V 2/9/1993 NATIONAL INSTITUTES OF HEALTH ANTI-FUNGAL DRUGS
### I II 2/11/1993 EGIS PHARMACEUTICALS PRIVATE LTD DOBUTAMINE HYDROCHLORIDE
### I III 2/4/1993 H AND N CHEMICAL CO PRESSURE SENSITIVE ADHESIVE CODED
POLYTAC 212X26
### A IV 2/1/1993 DAIKIN REFRIGERANTS EUROPE GMBH 1,1,1,2,3,3,3-HEPTAFLUOROPROPANE (R-227)
PROPELLANT GAS
### I II 2/22/1993 WHATMAN PAPER LTD DE52/D774 ANION EXCHANGE CELLULOSE
### I II 2/25/1993 GENZYME CORP CERAMIDETRIHEXOSIDASE
### A II 2/26/1993 DAIICHI SANKYO CO LTD LEVOFLOXACIN DRUG SUBSTANCE
### I II 2/22/1993 SAFC INC MECHLORETHAMINE HYDROCHLORIDE
Page 322
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 2/19/1993 OLON SPA NICARDIPINE HYDROCHLORIDE
### I II 2/22/1993 SEPPIC DIV AIR LIQUIDE MONTANOX 80DF
### I II 2/26/1993 ORIL INDUSTRIE DEXFENFLURAMINE HYDROCHLORIDE
### I II 2/26/1993 WATSON LABORATORIES INC PROGESTERONE VAGINAL SUPPOSITORY 100
MG. AND 200 MG.
### I IV 2/16/1993 MILES INC LEWATIT S 5428 A
### A II 2/23/1993 IPCA LABORATORIES LTD FUROSEMIDE USP
10110 A II 2/26/1993 COPPERHEAD INVESTMENTS INC SDM-74 (20/80 NITROGLYCERIN-SOLVATED
ADHESIVE POLYMER)
10111 I III 2/22/1993 SCHUBERT SEALS AS RUBBER COMPOUND NO. 6457
10112 I II 4/30/1980 LEDERLE LABORATORIES DIV PIPERACILLIN MONOHYDRATE
AMERICAN CYANAMID CO
10113 I III 2/22/1993 AMPACET CORP 100267 AS MB
10114 I II 3/1/1993 KURARAY CO LTD 1S,3S,4R-3-(2-PROPENYL)-BICYCLO[2,2,1]
HEPTAN-2-ONE
10115 I II 3/3/1993 PHARMACO LIFE SCIENCE RESEARCH METHOD VALIDATION REPORT, METHOD 29,
GC/MS ANALYSIS OF UNCONJUGATED ESTRONE
AND 17B-ESTRADIOL IN HUMAN PLASMA
Page 326
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 5/5/1993 PRODUCTOS QUIMICOS NATURALES SA FLUORANDROSTENONE
DE CV
### I II 5/5/1993 JOHNSON MATTHEY INC AUROTHIOGLUCOSE
### I II 4/30/1993 TAKEDA CHEMICAL INDUSTRIES LTD TAK-536 DRUG SUBSTANCE
### I II 4/23/1993 ALDRICH CHEMICAL CO INC ISOBUTYRAMIDE
### I II 4/23/1993 ALDRICH CHEMICAL CO INC BUTYRIC ACID
### A III 5/5/1993 3M DRUG DELIVERY SYSTEMS 3M SCOTCHPAK 9742 RELEASE LINER
### I IV 4/22/1993 AQUALON CO HYDROXYETHYL CELLULOSE
### A III 4/26/1993 BD MEDICAL - PHARMACEUTICAL MONOVIAL-INF. NG (DRUG CONTAINER AND
SYSTEMS CLOSURE)
### I II 5/7/1993 JOHNSON MATTHEY INC GOLD SODIUM THIOMALATE
### I II 3/6/1993 LABOCHIM SPA LEUCOVORIN CALCIUM
### I II 5/5/1993 CILAG AG RIMANTADINE HYDROCHLORIDE
### I II 5/4/1993 NORTH CHINA PHARMACEUTICAL CORP PENICILLIN G POTASSIUM CRUDE
### I II 5/5/1993 TEVA PHARMACEUTICAL INDUSTRIES SELEGILINE HYDROCHLORIDE
LTD
### I II 4/14/1993 BK LADENBURG GMBH PHOSKADENT SF (SODIUM FLUORIDE)
### I II 4/14/1993 BK LADENBURG GMBH PHOSKADENT TM (SODIUM
TRIMETAPHOSPHATE)
### I II 4/14/1993 BK LADENBURG GMBH DENTPHOS C (CALCIUM HYDROXYLAPATITE)
### I I 4/22/1993 PRIMA PHARM INC FACILITY AND OPERATING PROCEDURES IN
SAN DIEGO, CALIFORNIA
### I II 5/10/1993 TATEYAMA KASEI CO LTD TOYAMA PLANT IN TOYAMA PREF., JAPAN
### I II 5/7/1993 NV ORGANON FACILITY AND PROCEDURES IN OSS, THE
NETHERLANDS - MOLENSTRAAT 110
### A II 4/26/1993 BOEHRINGER INGELHEIM PHARMA DIHYDROERGOTAMINE MESYLATE
GMBH AND CO KG
### A V 4/30/1993 IONISOS FACILITY AND PROCEDURES FOR GAMMA RAY
STERILIZATION
### I I 5/7/1993 WILLIAM RANSON AND SON LTD FACILITY FOR THE
### A III 5/6/1993 HENKEL AG AND CO KGAA LIOFOL, LAMINATING ADHESIVE
### I III 5/12/1993 MITSUI PETROCHEMICAL AMERICA LTD ADMER QF551E
### I II 5/17/1993 DIOSYNTH BV PANCURONIUM BROMIDE
### I II 5/17/1993 WYCKOFF CHEMICAL CO INC FLURBIPROFEN SODIUM
### I III 5/14/1993 OMV WERKSTOFF PCD POLYMERE DAPLEN KS101
GMBH
### I II 5/18/1993 SYNKEM DIV PLASTO SA B.P. 102
### I II 5/14/1993 ABBOTT LABORATORIES PROTIRELIN (TRH)
### I III 5/21/1993 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMULATION V 7000-55
BLACK
### A II 5/12/1993 NEULAND LABORATORIES LTD BENZYL ALBUTEROL, INTERMEDIATE
### I II 5/12/1993 NEULAND LABORATORIES LTD ALBUTEROL SULFATE
### A V 5/18/1993 STERIS CONTRACT STERILIZATION FACILITY IN
WESTPORT MAYO, IRELAND
### I II 5/24/1993 KAKEN PHARMACEUTICAL CO LTD KP-102
Page 327
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 5/20/1993 OTSUKA PHARMACEUTICAL CO LTD FORMULATION RESEARCH INSTITUTE IN
TOKUSHIMA, JAPAN
### I III 5/3/1993 GETTIG PHARMACEUTICAL GETTIG NEEDLE ASSEMBLY
INSTRUMENT CO
### A III 5/21/1993 OWENS BROCKWAY GLASS CONTAINER GLASS CONTAINERS (FLINT AND AMBER)
INC
### I IV 5/17/1993 BENTLEY PHARMACEUTICALS INC CYCLOPENTADECANOLIDE
### I II 5/26/1993 BIOREX RESEARCH DEVELOPMENT CO MOLINDONE HYDROCHLORIDE
### I II 5/25/1993 JETPHARMA SA CONTRACT MICRONIZATION SERVICES
LOCATED IN BALERNA, SWITZERLAND
### I II 5/27/1993 TAKEDA CHEMICAL INDUSTRIES LTD TAP-144-SR(N) 7.5 AND 3.75 MG.
### I II 5/24/1993 LONZA INC DEXTROMETHORPHAN BASE
### I II 5/17/1993 ZAMBON GROUP SPA WAY-125,147 CRUDE
### I II 6/3/1993 SMITHKLINE BEECHAM BRL 47539 (2-ACETOXYMETHYL-4-IODOBUT-1-
PHARMACEUTICALS YL-ACETATE)
### I II 6/3/1993 SMITHKLINE BEECHAM BRL 47539 (2-ACETOXYMETHYL-4-IODOBUT-1-
PHARMACEUTICALS YL-ACETATE)
### I II 6/3/1993 WELLSPRING PHARMACEUTICAL CORP DIBENZYLINE (SK&F 688-A) SOLUTION FOR
INJECTION
### I IV 6/2/1993 PARKE DAVIS DIV WARNER LAMBERT CAPILL
CO
### I II 5/26/1993 LONZA LTD DEBMEB
### I III 5/25/1993 TEMPIL DIV BIG THREE INDUSTRIES INC SERIES 200 POLYMER ACTIVATED INKS
### I II 5/28/1993 ABBOTT LABORATORIES LTD SEMI-WORKS AREA IN QUEENBOROUGH, KENT,
UNITED KINGDOM
### A II 5/27/1993 UNION QUIMICO FARMACEUTICA SA RANITIDINE HYDROCHLORIDE (CRYSTALLINE
(UQUIFA SA) FORM 1)
### A II 6/4/1993 CU CHEMIE UETIKON GMBH PHENYLACETIC ACID SODIUM SALT
### I II 6/4/1993 PENINSULA LABS INC TJN-135
### I III 5/28/1993 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMULATION B5004-50
GRAY
### A III 5/31/1993 FUJIMORI KOGYO CO LTD RELEASE LINER FILM
### I II 6/3/1993 BIO RAD BIO-GEL A-5M, MEDIUM
### I II 6/3/1993 BIO RAD PC CROSSLINKED BIO-GEL A-5M, MEDIUM
### I II 6/7/1993 UNIQUE CHEMICALS NIFEDIPINE
### I II 6/8/1993 NORTH CHINA PHARMACEUTICAL CORP CYCLOSPORINE, USP (BULK, NON-STERILE)
### I II 6/3/1993 JUZEN CHEMICAL CORP METHYL (2R,3S)-3-(4-METHOXYPHENYL)-2,3-
EPOXYPROPIONATE
### I II 6/10/1993 BACHEM FEINCHEMIKALIEN AG DESMOPRESSIN ACETATE
### I III 6/11/1993 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMULATION B5002-50
RED
### I III 6/7/1993 BASELL POLIOLEFINE ITALIA SPA LUPOLEN 5261 ZS
### I III 6/9/1993 TEKNI-PLEX INC F93SR-1
### I II 6/14/1993 BIO RAD AG 1-X2 RESIN, 200-400 MESH, ACETATE
Page 328
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 6/14/1993 JOHNSON MATTHEY PHARMACEUTICAL CARMUSTINE
MATERIALS
### A III 6/9/1993 MULTISORB TECHNOLOGIES INC DESIMAX®
### I V 6/12/1993 FUJISAWA PHARMACEUTICAL CO LTD STERILE PROCESSING FACILITIES FOR
PROGRAF(TACOLIMUS) AMPOULES AS LOCATED
IN BANSAGH, KILLOGLIN, CO. KERRY, IRELAND.
### I II 6/11/1993 LABORATOIRES SERONO SA BULK GRF (1-29) NH2 (SERMORELIN ACETATE
DRUG SUBSTANCE)
### A II 6/14/1993 ASPEN OSS BV OXYTOCIN
### I II 6/17/1993 ZENECA PHARMACEUTICALS HALOTHANE
### I II 6/14/1993 CHEMSYN SCIENCE LABORATORIES DOBUTAMINE HYDROCHLORIDE
### I II 6/17/1993 CHINOIN PHARMACEUTICAL CHEMICAL GLIBENCLAMIDE BP88 (GLYBURIDE)
WORKS
### I II 6/14/1993 ROFERM SPA 7-AMINOCEPHALOSPORANIC ACID
### I II 6/15/1993 BRACCO IND CHIMICA SPA IOMEPROL
### I III 6/18/1993 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMULATION B5005-45
GRAY
### I II 6/11/1993 ARCHER DANIELS MIDLAND CO POTASSIUM CITRATE MONOHYDRATE
### I II 6/18/1993 UNIQUE CHEMICALS FACILITY AND PROCEDURES IN ANKLESHWAR,
INDIA
### A II 4/1/1987 ACS DOBFAR SPA ACID CEFAZOLIN (INTERMEDIATE GRADE)
### A V 6/24/1993 BAXTER PHARMACEUTICALS STERILE PROCESSING FACILITY
SOLUTIONS LLC
### I II 6/29/1993 ONO PHARMACEUTICAL CO LTD FACILITY AND OPERATING PROCEDURES IN
OSAKA, JAPAN
### I III 6/16/1993 ACTION COLOR INC ACPP-80071 COLORANT
### I II 6/29/1993 CREAPHARM SA FACILITY AND OPERATING PROCEDURES IN LE
HAILLAN, FRANCE
### I I 6/29/1993 3M BIOAPPLICATIONS 3M EMPHAZE AB 1 SUPPORT MEDIUM
### A II 6/30/1993 SANOFI CHIMIE IRBESARTAN DRUG SUBSTANCE
10311 I II 6/28/1993 BURZYNSKI RESEARCH INSTITUTE INC ANTINEOPLASTON A10 INJECTIONS
### I II 6/25/1993 LIPHA SAS FACILITY AND PROCEDURES IN SEMOY,
FRANCE
### I III 6/14/1993 BASF AKTIENGESELLSCHAFT NOVOLEN 1125 N
### I III 6/14/1993 BASF AKTIENGESELLSCHAFT NOVOLEN 1325 M
### I II 6/16/1993 LUSOCHIMICA SPA RITODRINE HYDROCHLORIDE
### I II 6/25/1993 SIPSY CHIMIE FINE SCA PENTAMIDINE ISETHIONATE
### I II 6/25/1993 LONZA RIVERSIDE TRANYLCYPROMINE SULFATE
### A III 6/29/1993 BAYPORT POLYMERS LLC MANUFACTURE OF POLYETHYLENE
### I II 6/24/1993 CATALENT PHARMA SOLUTIONS LLC HYTRIN (TERAZOSIN) SOFT GELATIN CAPSULES
### A II 6/24/1993 MALLADI DRUGS AND D-PSEUDOEPHEDRINE HYDROCHLORIDE
PHARMACEUTICALS LTD
### I II 6/25/1993 DAINIPPON SUMITOMO PHARMA CO LTD MEROPENEM/SODIUM CARBONATE
### A II 6/25/1993 SUMITOMO DAINIPPON PHARMA CO LTD MEROPENEM
Page 329
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 6/17/1993 NAGASE FINE CHEMICALS LTD METHYL (2R,3S)-(4-METHOXYPHENYL)-2,3-
EPOXYPROPIONATE
### I II 6/24/1993 CCL INDUSTRIES LTD FACILITY AND OPERATING PROCEDURES IN
RUNCORN, UNITED KINGDOM
### I III 6/24/1993 BASF AKTIENGESELLSCHAFT ULTRAPEK A 1000
### I III 6/24/1993 BASF AKTIENGESELLSCHAFT ULTRAPEK A 2000
### I III 6/24/1993 BASF AKTIENGESELLSCHAFT ULTRAPEK A 3000
### I IV 6/14/1993 NOVILLE ESSENTIAL OIL CO INC FLAVOR AN106248
### I III 6/10/1993 PHILLIPS PLASTICS CORP CUSTOM INJECTION MOLDING OF
COMPONENTS FOR POCKETHALER FOR
NASONEX
### I III 7/1/1993 WHEATON PHARMATECH N4003-45 PINK
### I III 6/26/1991 SCHUPBACH AG COMPOUND PACKAGING MATERIAL FOR
NICOTIN-TTS
### I III 3/30/1989 SCHUPBACH AG TRANSDERM-NITRO TTS BACKING FILM
### A III 6/29/1993 PREMIX OY PREWHITE PE 10-50,PREWHITE PP 22-50 AND
PREWHITE PE 13-60
### A II 7/6/1993 CHATTEM CHEMICALS INC HYDROXYAMPHETAMINE HYDROBROMIDE USP
### A II 6/29/1993 AGC INC QN-3 CARBOXYLIC ACID
### I II 7/12/1993 HAFSLUND NYCOMED PHARMA AG AMINOBISAMIDE-HYDROCHLORIDE
### I II 7/12/1993 PHARMACIA AND UPJOHN FACILITY AND OPERATING PROCEDURES IN
STOCKHOLM, SWEDEN
### I II 7/12/1993 PHARMACIA AND UPJOHN FACILITY AND OPERATING PROCEDURES AT
THE BRUNNA FACILITY IN KUNGSANGEN,
SWEDEN
### I II 7/12/1993 PHARMACIA AND UPJOHN CO FACILITY AND OPERATING PROCEDURES IN
STRANGNAS, SWEDEN
### A II 6/28/1993 SIEGFRIED PHARMACHEMIKALIEN SELEGILINE HYDROCHLORIDE
MINDEN GMBH
### I III 7/6/1993 AMPACET CORP 100319 AS MB
### I III 7/6/1993 AMPACET CORP 100320 AS MB
### I III 6/29/1993 BASF AKTIENGESELLSCHAFT SICOLEN BLUE 69-0964
### I III 6/29/1993 BASF AKTIENGESELLSCHAFT RAKUSOL WHITE 00-2207
### I III 6/29/1993 BASF AKTIENGESELLSCHAFT RAKUSOL BLUE 62-9607
### I III 6/29/1993 BASF AKTIENGESELLSCHAFT RAKUSOL BLUE 70-9007
### I III 5/22/1993 PRESSPART MANUFACTURING LTD PHARMACEUTICAL AEROSOL CANS
### A III 7/8/1993 ALBEA AMERICAS INC LAMINATE TUBES
### I II 7/12/1993 BURZYNSKI RESEARCH INSTITUTE INC ANTINEOPLASTON AS2-1 INJECTIONS
### I II 6/23/1993 ZAKLADY FARMACEUTYCZNE TINIDAZOLE
POLPHARMA SA
### A III 7/9/1993 GERRESHEIMER LOHR GMBH GLASS CONTAINERS
### A III 7/6/1993 CLARIANT PLASTICS AND COATINGS MASTERBATCH PE-10993
NORDIC AB
### A II 7/13/1993 BAYER AG CIPROFLOXACIN HYDRATED DRUG SUBSTANCE
Page 330
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 7/6/1993 MARVAL MARVAL M-800 NATURAL
### I III 6/8/1993 H AND N CHEMICAL CO PRESSURE SENSITIVE CODED POLYTAC 5135-1
### I IV 9/21/1993 SEPRACOR INC BLUE TRISACRYL AND BLUE TRISACRYL PLUS
### I III 9/13/1993 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMULATION B5021-45
GRAY
### I II 9/24/1993 QUALITY CHEMICALS INC FACILITY AND OPERATING PROCEDURES IN
DAYTON, OHIO
### A II 9/15/1993 SOCIETA ITALIANA MEDICINALI TICLOPIDINE HYDROCHLORIDE
SCANDICCI SIMS SRL
### A II 9/23/1993 ASPEN OSS BV BUDESONIDE
### I II 9/27/1993 CTRC RESEARCH FDN FACILITIES, SITE AND PERSONNEL IN SAN
ANTONIO, TEXAS
### A IV 9/23/1993 IOI OLEO GMBH MIGLYOL 829
### I II 9/24/1993 HOFFMANN LA ROCHE INC NITOMAN (TETRABENAZINE) TABLETS
### I II 9/24/1993 GEDEON RICHTER USA INC FLUTAMIDE
### A II 9/28/1993 GRAIN PROCESSING CORP ETHYL ALCOHOL PRODUCTS
### A II 9/29/1993 CATALENT PHARMA SOLUTIONS LLC IBUPROFEN SOFTGELS, 200 MG.
### A III 9/23/1993 BEATSON CLARK PLC AMBER GLASS CONTAINERS
### I III 9/23/1993 BEATSON CLARK PLC WHITE FLINT GLASS CONTAINERS
### I IV 9/21/1993 KERRY INGREDIENTS AND FLAVOURS NATURAL CHERRY WONF 717082
DBA MASTERTASTE INC
Page 335
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I IV 9/21/1993 J MANHEIMER INC NATURAL AND ARTIFICIAL CHERRY FLAVOR
606947
### I II 9/29/1993 NAPRO BIOTHERAPEUTICS INC PACLITAXEL DRUG SUBSTANCE
### I II 9/29/1993 LONZA LTD 2-BUTYL-5-CHLORO-1H-IMIDAZOLE-4-
CARBOXALDEHYDE
### I III 9/7/1993 FERRO CORP NPPOONPO4NA (ALTERNATIVELY X53-041 OR
CPC27-4555)
### I II 9/30/1993 BTR SEPARATIONS ZORBAX
### I IV 9/23/1993 CREMER OLEO GMBH AND CO KG IMWITOR 742
### I II 9/21/1993 LONZA LTD FACILITY AND OPERATING PROCEDURES IN
VISP, SWITZERLAND
### I II 9/27/1993 LIQUID CARBONIC INDUSTRIES CORP NITRIC OXIDE IN NITROGEN GAS MIXTURE
BULK GASES PRODUCED IN OAK BROOK, ILLINOIS
10511 I II 9/24/1993 BTR SEPARATIONS FACILITIES AND OPERATING PROCEDURES IN
MILAN, ITALY.
### I II 10/4/1993 LABORATORIOS SERONO SA BACTERIOSTATIC SODIUM CHLORIDE
INJECTION
### A II 10/5/1993 VALEANT PHARMACEUTICALS NORTH PIRBUTEROL ACETATE
AMERICA LLC
### A II 10/8/1993 LEO PHARMA AS CALCIPOTRIENE HYDRATE DRUG SUBSTANCE
### A II 10/8/1993 LEO PHARMA AS CALCIPOTRIENE CREAM DRUG PRODUCT
### I II 10/5/1993 RANBAXY LABORATORIES LTD RANITIDINE HYDROCHLORIDE
### A II 9/30/1993 OLON SPA LOPERAMIDE HYDROCHLORIDE
### A II 9/30/1993 OLON SPA MICONAZOLE NITRATE
### A II 10/8/1993 ASPEN OSS BV DANAPAROID SODIUM
### I II 9/30/1993 ORGAMOL SA MOEXIPRIL HYDROCHLORIDE
### I II 10/5/1993 SANDOZ AG FACILITIES AND PROCEDURES IN NUREMBERG,
GERMANY
### I III 10/8/1993 INTERNATIONAL TRADING CORP PROLEN XM6150K, HY6100, AND SM6100K
### I II 10/7/1993 UPSHER SMITH LABORATORIES INC NIACOR (IMMEDIATE-RELEASE NIACIN TABLETS)
Page 337
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 11/12/1993 SAFC BIOSCIENCES INC EX-CELL 300 (MBS) W/L-GLUTAMINE, HEPES,
NAHC03, GALACTOSE W/O PHENOL RED (CAT.
NO. 14035)
### I II 11/8/1993 ALBERT DAVID LTD FACILITY AND OPERATING PROCEDURES IN
CALCUTTA, INDIA
### I II 11/5/1993 MAROPACK AG FACILITIES AND OPERATING PROCEDURES IN
ZELL/LUCERNE, SWITZERLAND.
### I II 11/9/1993 PHARMACIA AND UPJOHN BIZELESIN (U-77779) DRUG SUBSTANCE
### I II 11/12/1993 RANBAXY LABORATORIES LTD TERFENADINE
### I II 11/4/1993 DAIICHI ASUBIO PHARMA CO LTD SUN A0026 DRUG SUBSTANCE
### I I 11/4/1993 SUNTORY BIO PHARMA TECH CENTER MANUFACTURING SITE AT THE CHIBA PLANT IN
CHIBA-CITY, CHIBA, JAPAN
### I IV 11/10/1993 ENCAPSULATION SYSTEMS INC DELTA STARCH 901
### I II 11/11/1993 3V PARTECIPAZIONI INDUSTRIALI SPA UVASORB MET/C
### I II 11/11/1993 3V PARTECIPAZIONI INDUSTRIALI SPA MANUFACTURING FACILITY IN MOZZO, ITALY
### I II 11/17/1993 BACHEM INC DESLORELIN PAMOATE
### I II 11/18/1993 INTERPHARMA PRAHA AS IODIPAMIDE DRUG SUBSTANCE
### I II 11/8/1993 ALDRICH CHEMICAL CO INC 2,5-DIHYDROXYBENZOIC ACID
### I IV 11/5/1993 CARRUBBA INC FLAVOR CONCENTRATE # 48119
### I II 11/16/1993 KV PHARMACEUTICAL CO MICONAZOLE VAGINAL CREAM
### A IV 11/17/1993 IOI OLEO GMBH SOFTISAN 378
### A V 11/19/1993 NERPHARMA SRL STERILE PRODUCTS FACILITIES
### I II 11/19/1993 SCHUTZ AND CO TRIPELENNAMINE HYDROCHLORIDE
### I III 10/27/1993 BASF AKTIENGESELLSCHAFT NOVOLEN 1100 L
### I III 10/27/1993 BASF SE ULTRADUR B 4520
### I III 12/1/1993 INTRAPAC CORP COLLAPSIBLE ALUMINUM TUBES
### I II 11/22/1993 BOEHRINGER INGELHEIM PHARMA KG LOBELINE SULFATE
### I III 11/9/1993 CEBAL VERPACKUNGEN GMBH AND CO ALUMINUM TUBES, CAPS AND AEROSOL CANS
KG
### A III 11/18/1993 JOHN C BROW LTD TA BROW STATPAK (TM) FP
PACKAGING
### I II 11/22/1993 LEO PHARMACEUTICAL PRODUCTS LTD HEPARIN SODIUM DRUG SUBSTANCE
Page 338
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 12/7/1993 LEO PHARMACEUTICAL PRODUCTS LTD INNOHEP INJECTION 20,000 ANTI-XA IR/ML
Page 340
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 12/10/1993 RELIABLE BIOPHARMACEUTICAL CORP FACILITIES, PERSONNEL AND GENERAL
OPERATING PROCEDURES IN SAINT LOUIS,
MISSOURI
### I II 12/9/1993 CYGNUS INC ESTRADIOL TRANSDERMAL DELIVERY SYSTEM
(E2 III TDS)
### I II 1/10/1994 GADOR SA ZOLPIDEM HEMITARTRATE
### I I 12/28/1993 KATAYAMA SEIYAKUSYO CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN OSAKA, JAPAN.
### I II 12/28/1993 KATAYAMA SEIYAKUSYO CO LTD GLYCL-L-GLUTAMINE
### I II 12/6/1993 PCAS BISMUTH CITRATE
### I II 1/7/1994 SIGMA ALDRICH MANUFACTURING LLC GLYCYLGLYCINE (PRODUCT NO. W 5310-8)
### I III 12/23/1993 BASF AKTIENGESELLSCHAFT RAKUSOL BLUE 68-5647
### I II 1/6/1994 SIGMA F AND D DIV LTD COLLAGEN (PRODUCT NO. C 9301)
### I III 2/14/1994 DSM POLYMERS STAMYLAN HD 9630
### I II 1/6/1994 CELOX CORP SERUM-FREE CELL GROWTH MEDIUM
### I II 1/5/1994 GLAXO WELLCOME INC MANUFACTURING FACILITY AT VERONA, ITALY.
### I III 12/1/1993 LOPAREX BV GELROFLEX ALU-PET 100 M - 25
### I II 12/1/1993 SEPRACOR INC HYPER - D ION EXCHANGERS
### I II 1/5/1994 PFIZER IRELAND PHARMACEUTICALS FEDOTOZINE TARTRATE
### I II 12/6/1993 PCAS MANUFACTURING FACILITY FOR "BISMUTH
CITRATE" AT LA VOULTE SUR RHONE
### A III 1/18/1994 MEDISIZE SCHWEIZ AG RAW MATERIALS AND MANUFACTURING
CONTROLS UTILIZED IN PRODUCTION OF
PLASTIC BOTTLES
### A II 1/12/1994 LOBA FEINCHEMIE GMBH NAPHAZOLINE HYDROCHLORIDE
### I III 1/4/1994 HELVOET PHARMA MARYLAND SIL FREE COATED STOPPERS FOR DRUG
PACKAGING
### I III 1/6/1994 ECP ENICHEM POLYMERES FRANCE RIBLENE MP30
### I III 1/10/1994 COIM USA INC NOVACOTE ADH260-805
### A II 1/10/1994 EXCELLA GMBH AND CO KG ACICLOVIR
### I II 12/22/1993 SCHERING AG ONAPRISTONE
### I II 12/15/1993 CHEMICAL PHARMACEUTICAL FACILITY AND PROCEDURES IN SOFIA,
RESEARCH INSTITUTE NIHFI LTD BULGARIA
### I II 12/15/1993 CHEMICAL PHARMACEUTICAL FENOFIBRATE
RESEARCH INSTITUTE NIHFI LTD
### I II 12/15/1993 CHEMICAL PHARMACEUTICAL PROPANOLOL HYDROCHLORIDE
RESEARCH INSTITUTE NIHFI LTD
### I II 12/15/1993 CHEMICAL PHARMACEUTICAL KETOTIFEN HYDROGEN
RESEARCH INSTITUTE NIHFI LTD
### I II 12/15/1993 CHEMICAL PHARMACEUTICAL FLUNARIZINE HYDROCHLORIDE
RESEARCH INSTITUTE NIHFI LTD
### I II 12/15/1993 CHEMICAL PHARMACEUTICAL PRAZOSIN HYDROCHLORIDE
RESEARCH INSTITUTE NIHFI LTD
Page 341
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 12/15/1993 CHEMICAL PHARMACEUTICAL BROMOCRIPTINE MESYLATE
RESEARCH INSTITUTE NIHFI LTD
### I II 12/15/1993 CHEMICAL PHARMACEUTICAL AMIKACIN SULFATE
RESEARCH INSTITUTE NIHFI LTD
### I II 12/15/1993 CHEMICAL PHARMACEUTICAL TAMOXIFEN CITRATE
RESEARCH INSTITUTE NIHFI LTD
### I II 12/15/1993 CHEMICAL PHARMACEUTICAL RANITIDINE HYDROCHLORIDE
RESEARCH INSTITUTE NIHFI LTD
### I III 1/19/1994 WINPAK TECHNOLOGIES INC POUCH FOR POWDERED DRUGS
### I III 1/19/1994 WINPAK TECHNOLOGIES INC NON FORMING LIDDING FOR PILL PACKAGE
### A II 1/12/1994 OLON SPA ACYCLOVIR
### A III 1/21/1994 PERLEN CONVERTING AG PERLALUX BLISTER FILMS TWO AND THREE
LAYER
### I II 1/17/1994 CHINA SUZHOU NO 5 PHARMACEUTICAL METHACYCLINE HYDROCHLORIDE
FACTORY
### A II 1/24/1994 MAPRIMED SA FLECAINIDE ACETATE PROCESS I (CODE 50064)
Page 342
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
10711 I II 2/1/1994 ORGAMOL FRANCE SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ST. VULBAS, FRANCE.
### I II 2/4/1994 CHENG FONG CHEMICAL CO LTD FACILITY AND OPERATING PROCEDURES IN TAO
YUAN HSIEN, TAIWAN, R.O.C.
### A II 2/4/1994 CORDEN PHARMA BERGAMO SPA CLOTRIMAZOLE
### I II 2/2/1994 ICI KLEA 1,1,1,2-TETRAFLUOROETHANE
### I II 2/2/1994 ICI AMERICAS INC FACILITY AND PROCEDURES IN ST. GABRIEL,
LOUISIANA
### I II 2/2/1994 ICI LTD FACILITY AND OPERATING PROCEDURES IN
RUNCORN, CHESHIRE, UNITED KINGDOM
### I II 2/7/1994 ESTEVE QUIMICA SA LESOPITRON DIHYDROCHLORIDE
### I III 2/14/1994 DSM POLYMERS STAMYLEX 1016LF
### I II 1/20/1994 SHANDONG XIN HUA PHARMACEUTICAL FACILITY AND PROCEDURES IN ZIBO,
FACTORY SHANDONG, THE PEOPLE'S REPUBLIC OF
CHINA.
### I I 2/7/1994 CHEMINOR DRUGS PVT LTD FACILITIES, OPERATING PROCEDURES AND
PERSONNEL IN ANDHRA PRADESH, INDIA
### A III 1/28/1994 CHEVRON PHILLIPS CHEMICAL CO LP POLYETHYLENE COPOLYMER RESIN 6109
### A III 1/31/1994 GRUPPO MOSSI AND GHISOLFI POLYESTER RESINS
### I II 1/25/1994 KONICA CHEMICAL CORP FACILITIES AND PROCEDURES IN FUKUSHIMA,
JAPAN
### I II 2/2/1994 ICI KLEA 1,1,1,2-TETRAFLUORETHANE
### A II 2/18/1994 JANSSEN PHARMACEUTICA NV ITRACONAZOLE DRUG SUBSTANCE
### A III 2/7/1994 BPREX HEALTHCARE OFFRANVILLE SAS EYE-DROPPER 5, 11 AND 15 ML, PLUG, CAPS
Page 343
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 2/9/1994 PLASTINVENT I KARLSKOGA AB MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN KARLSKOGA, SWEDEN.
### I II 2/18/1994 SOCIETA ITALIANA MEDICINALI CROMOLYN SODIUM
SCANDICCI
### I II 2/24/1994 CENTRAL GLASS CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN UBE-CITY, JAPAN.
### I II 2/25/1994 EASTMAN CHEMICAL CO [5-METHYL-2-[(2-NITROPHENYL)AMINO]-3-
THIOPHENECARBONITRILE](COMMONLY
KNOWN AS TCN, STEP 2)
### A II 2/1/1994 NICOBRAND LTD NICOTINE POLACRILEX RESIN
### I II 2/23/1994 DELMAR CHEMICALS INC KETOROLAC TROMETHAMINE
### I II 2/28/1994 NIPPON RIKAGAKUYAKUHIN CO LTD CYSTEINE HYDROCHLORIDE
### I II 2/25/1994 FERRING AB FACILITY AND OPERATING PROCEDURES IN
MALMO, SWEDEN
### I III 2/25/1994 BILCARE INC PACKAGING SERVICES IN PHOENIXVILLE,
PENNSYLVANIA
### A III 10/18/1993 TEKNOR APEX CO MEDALIST MD-12243
### I III 2/8/1994 EDISON PLASTICS CO PACKAGING MATERIALS
### I III 2/21/1994 NESTE CHEMICALS POLYETHYLENE PRODUCT NCPE2224
### I II 2/25/1994 ARZNEIMITTELWERK DRESDEN GMBH FACILITY AND OPERATING PROCEDURES IN
RADEBEUL, GERMANY
### I II 3/3/1994 SOLVAY DUPHAR BV CHOLECALCIFEROL (VITAMIN D3)
### I II 3/1/1994 SUMIKA FINE CHEMICALS CO LTD 5MACA (INTERMEDIATE)
### I II 1/25/1994 BACHEM INC PEPTIDE AL-204
### A II 3/4/1994 JANSSEN PHARMACEUTICA NV INTERMEDIATE T000034
### I II 3/4/1994 JANSSEN PHARMACEUTICA NV INTERMEDIATE T000015
### I II 3/4/1994 JANSSEN PHARMACEUTICA NV INTERMEDIATE T000506
### I II 3/4/1994 JANSSEN PHARMACEUTICA NV INTERMEDIATE T000509
### I IV 2/18/1994 TIMERX TECHNOLOGIES CONTROLLED RELEASE EXCIPIENT
### I II 2/28/1994 RAYLO CHEMICALS INTERMEDIATE FOR ACA-147, 4-(2,2-
DIMETHYLPROPYL)-N-
HEXYLBENZENEMETHANAMINE
HYDROCHLORIDE
### I II 2/21/1994 NESTE CHEMICALS FACILITY AND MANUFACTURING PROCEDURES
IN PORVOO, FINLAND
### I II 3/8/1994 PEPTISYNTHA SA LY297141
### I II 3/3/1994 AKZO NOBEL CHEMICALS BV DISSOLVINE E-CA-10 (EDETATE CALCIUM
DISODIUM USP)
### I II 3/3/1994 AKZO NOBEL CHEMICALS BV DISSOLVINE NA-2-P (EDETATE DISODIUM USP)
### I IV 3/4/1994 LIPOID GMBH LIPOID S 75-MCT
### A II 2/28/1994 COPPERHEAD INVESTMENTS INC SDM-78
### I II 2/28/1994 SYNTHELABO RECHERCHE ELIPRODIL HYDROCHLORIDE
### I III 2/15/1994 BASF AKTIENGESELLSCHAFT NOVOLEN 2600 PCX
Page 344
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 3/10/1994 SELOC FRANCE FLUNIXIN MEGLUMINE
### I III 3/8/1994 GERRESHEIMER BUNDE GMBH DISPOSABLE SYRINGE SYSTEM
### I III 3/7/1994 RESCO COLOURS INC 01EHD-225
### I II 2/18/1994 IPCA LABORATORIES LTD IBD-IV MANUFACTURING FACILITY IN RATLAM,
INDIA
### I II 3/14/1994 FUJISAWA PHARMACEUTICAL CO LTD RHIZOXIN
### I II 3/11/1994 NIPPON PROTEIN CO LTD N-ACETYL-D-GLUCOSAMINE
### I II 3/10/1994 CERESTAR USA INC FACILITIES AND OPERATING PROCEDURES IN
WAUKEGAN, ILLINOIS
### I IV 3/10/1994 WACKER CHEMICAL CORP HYDROXYPROPYL BETA CYCLODEXTRIN
(HPBCD)
### I III 3/1/1994 GERRESHEIMER GLAS AG KIMBLE ITALIANA KI101 GLASS, KI201 GLASS
### A III 1/31/1994 CODING PRODUCTS SV-19811 HOT STAMP INK RIBBON
### I III 1/31/1994 CODING PRODUCTS TTR-5903 AND TTR-7903 THERMAL TRANSFER
INK RIBBONS
### A III 1/31/1994 CODING PRODUCTS SV-19154 HOT STAMP INK RIBBON
### I III 1/31/1994 CODING PRODUCTS SV-16391 HOT STAMP INK RIBBONS
### I III 1/31/1994 CODING PRODUCTS DOI-1A AND DOI-1A 3/4 HOT STAMP INK RIBBONS
### A III 1/31/1994 CODING PRODUCTS DOI-6 HOT STAMP INK RIBBON
### I III 1/31/1994 CODING PRODUCTS SV-16810
### I III 1/31/1994 CODING PRODUCTS SV-17805
### I III 1/31/1994 CODING PRODUCTS TTR-5907, TTR-5908, TTR-7907 AND TTR-7908
THERMAL TRANSFER IN RIBBONS
### I III 1/31/1994 CODING PRODUCTS TTR-5901, TTR-5902, TTR-7901 AND TTR-7902
THERMAL TRANSFER INK RIBBONS
### A III 1/31/1994 CODING PRODUCTS SV-16356 HOT STAMP INK RIBBON
### A III 1/31/1994 CODING PRODUCTS SV-14808 HOT STAMP INK RIBBON
### A III 1/31/1994 CODING PRODUCTS SV-15807 HOT STAMP INK RIBBON
### I III 1/31/1994 CODING PRODUCTS TTR-7909 THERMAL TRANSFER INK RIBBON
### I III 1/31/1994 CODING PRODUCTS DOI-6A HOT STAMP INK RIBBON
### A III 1/31/1994 CODING PRODUCTS DOI-9 HOT STAMP INK RIBBON
### I III 1/31/1994 CODING PRODUCTS DS-1 HOT STAMP INK RIBBON
### I III 1/31/1994 CODING PRODUCTS FOI-3 HOT STAMP INK RIBBON
### I III 1/31/1994 CODING PRODUCTS FOI-4 HOT STAMP INK KRIBBON
### I III 1/31/1994 CODING PRODUCTS TTR-5900 THERMAL TRANSFER INK RIBBON
### A III 1/31/1994 CODING PRODUCTS CDF-1 AND CDF-1 3/4 HOT STAMP INK RIBBON
### I III 1/31/1994 CODING PRODUCTS CDF-4P HOT STAMP INK RIBBON
### A III 1/31/1994 CODING PRODUCTS CDF-6 HOT STAMP INK RIBBON
### A III 1/31/1994 CODING PRODUCTS CDF-9 AND CDF-9 3/4 HOT STAMP INK RIBBON
### I III 1/31/1994 CODING PRODUCTS CDF-634 HOT STAMP INK RIBBON
### I III 1/31/1994 CODING PRODUCTS CDF-63 HOT STAMP INK RIBBON
### I III 1/31/1994 CODING PRODUCTS CDF-14 HOT STAMP INK RIBBON
### A III 1/31/1994 CODING PRODUCTS CDF-98 HOT STAMP INK RIBBON
### I III 1/31/1994 CODING PRODUCTS DB-1 HOT STAMP INK RIBBON
Page 345
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 1/31/1994 CODING PRODUCTS DB-14 HOT STAMP INK RIBBON
### A III 1/31/1994 CODING PRODUCTS DOI-1 AND DOI-1 3/4 HOT STAMP INK RIBBONS
### I III 1/31/1994 CODING PRODUCTS CDF-33 HOT STAMP INK RIBBON
### I III 1/31/1994 CODING PRODUCTS CDF-96 HOT STAMP INK RIBBON
### I III 1/31/1994 CODING PRODUCTS CDF-95 HOT STAMP INK RIBBON
### I III 1/31/1994 CODING PRODUCTS CDF-93 HOT STAMP INK RIBBON
### I III 1/31/1994 CODING PRODUCTS CDF-94 HOT STAMP INK RIBBON
### I III 1/31/1994 CODING PRODUCTS CDF-92 HOT STAMP INK RIBBON
10811 I III 1/31/1994 CODING PRODUCTS CDF-37 HOT STAMP INK RIBBON
### A II 3/15/1994 ALBEMARLE CORP MACA (5-METHANESULFONYLAMINOINDOLE-2-
CARBOXYLIC ACID)
### I II 3/15/1994 JANSSEN PHARMACEUTICA NV INTERMEDIATE T000743
### I II 3/16/1994 LABORATOIRES SERONO SA STERILE DILUENT (0.3% M-CRESOL)
### I III 3/16/1994 SCHUPBACH AG COMPOUND PACKAGING MATERIAL #SOP 25255
PAPER/PE/ALU/LONOMER
### I III 3/9/1994 PACUR INC PETG COPOLYESTER 6763 MATERIAL
### I II 3/15/1994 BACHEM FEINCHEMIKALIEN AG 1-HYDROXY-2-NAPHTHOYL-ARG-PRO-NH2
HYDROCHLORIDE
### I II 3/18/1994 CHEMOX CHEMICAL INDUSTRIES LTD SULFAMETHOXAZOLE
### I III 3/10/1994 MORGAN ADHESIVES CO ROLL PHARMACEUTICAL LABEL PRODUCT LINE
PRODUCTS DIV
### I II 3/17/1994 BIOVAIL CORP INTERNATIONAL MANUFACTURING FACILITIES IN STEINBACH,
CANADA.
### I II 4/12/1994 CHINOIN PHARMACEUTCIAL AND FACILITY FOR THE MANUFACTURE OF
CHEMICAL WORKS CO LTD SELEGILINE HYDROCHLORIDE IN BUDAPEST,
HUNGARY
### I II 3/18/1994 CHEMOX CHEMICAL INDUSTRIES LTD FACILITIES AND PROCEDURES IN GUJARAT,
INDIA.
### I II 3/18/1994 DOTTIKON EXCLUSIVE SYNTHESIS AG ISOSORBIDE-5-NITRATE EXTENDED RELEASE
PREMIXTURE 49.2%
### A III 3/20/1994 POLYONE CORP GLS THERMOPLASTIC THERMOPLASTIC ELASTOMER COMPOUNDS
ELASTOMERS
### I II 3/25/1994 JICHENG PHARMACEUTICAL FACTORY MINOXIDIL
### I III 3/1/1994 GERRESHEIMER GLAS AG KIMBLE N51A GLASS, KIMBLE AMBER 203 GLASS
AND KIMBLE KG-33 GLASS
### I III 3/23/1994 LABORATORIOS DR ESTEVE SA FACILITIES AND PERSONNEL IN MARTORELLAS
(BARCELONA), SPAIN.
### I II 3/24/1994 JANSSEN PHARMACEUTICA NV FACILITIES, PERSONNEL AND GENERAL
OPERATING PROCEDURES IN BEERSE,
BELGIUM.
### I II 3/22/1994 DR REDDYS LABORATORIES LTD 2,6-DIISOPROPYLPHENOL
### A II 3/24/1994 YUNG ZIP CHEMICAL IND CO LTD ACYCLOVIR
### A II 3/24/1994 YUNG ZIP CHEMICAL IND CO LTD DICLOFENAC POTASSIUM
### I III 3/21/1994 MILLIKEN AND CO PC COLORANTS
### I II 3/25/1994 SIANG TA PHARMACEUTICAL CO LTD METHOCARBAMOL
Page 346
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 3/25/1994 SANDOZ CANADA INC FACILITIES AND PROCEDURES IN WHITBY,
ONTARIO, CANADA.
### I II 3/24/1994 HANJIANG PHARMACEUTICAL FACTORY FACILITY AND PROCEDURES IN HANZHONG
CITY, SHAANXI PROVINCE, CHINA.
### I II 3/30/1994 KYOWA HAKKO KOGYO CO LTD SODIUM HYALURONATE
### A II 3/28/1994 ERREGIERRE SPA FLUOXETINE HYDROCHLORIDE USP-EP
### A II 3/29/1994 SANDOZ GMBH 7-PACA (7-AMINO-3-PROPENYL-
CEPHALOSPORANIC ACID)
### I II 3/30/1994 LEO PHARMA AS CALCIPOTRIENE SCALP SOLUTION
### I II 3/30/1994 LEO PHARMACEUTICAL PRODUCTS LTD EB 1089
Page 347
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 4/11/1994 FERMENTACIONES Y SINTESIS NITRO-THIAZOLINE
ESPANOLAS SA
### I III 4/14/1994 CURWOOD INC PACKAGING MATERIALS
### I II 4/7/1994 ESTEVE QUIMICA SA AZT (ZIDOVUDINE)
### A II 4/12/1994 APOTEX PHARMACHEM INDIA PVT LTD DEFERIPRONE(L1)
### A II 4/20/1994 PRIME EUROPEAN THERAPEUTICALS PROPOFOL
SPA (EUTICALS SPA)
### I III 4/20/1994 STANIPAC AG POLYETHYLENE BAGS
### A IV 4/14/1994 SEPPIC SA MONTANIDE ISA 51 VG STERILE
### I II 4/14/1994 LAKESIDE CHEMICAL DEXFENFLURAMINE HYDROCHLORIDE
### I II 4/18/1994 JANSSEN RESEARCH FDN PIMOZIDE
### I II 4/14/1994 LABORATORIOS SERVIER SA DEXFENFLURAMINE BASE
### I V 4/13/1994 PHARMACO LIFE SCIENCE RESEARCH METHOD VALIDATION NITROGLYCERIN AND ITS
DINITROGLYCERIN METABOLITES IN HUMAN
PLASMA
### I I 4/14/1994 LABORATORIOS SERVIER SA FACILITIES AND PERSONNEL IN TOLEDO, SPAIN
### A II 4/7/1994 BIO-RAD LABORATORIES MACRO-PREP 50 EPOXIDE, DISTILLED SIZED
SUPPORT
### I II 4/11/1994 HELSINN ADVANCED SYNTHESIS SA PYRIDOSTIGMINE BROMIDE
### I II 4/26/1994 PEPTECH EUROPE AS GONADORELIN ACETATE
### I IV 4/15/1994 ROQUETTE AMERICA INC NEOSORB 70/20 SORBITOL SOLUTION
### A II 4/25/1994 PHYTEX AUSTRALIA PARTY LTD CASTANOSPERMINE
### A II 4/22/1994 HOYA CORP PENTAX HIGH CAPACITY CERAMIC
HYDROXYAPATITE
### I III 4/14/1994 RESCO COLOURS INC WHITE CONCENTRATE (01EHD-371)
### I II 4/19/1994 EURAND SPA PANCRELIPASE (ULTRASE) MINITABS
### I II 4/21/1994 AJINOMOTO CO INC GLYCYL-L-GLUTAMINE HYDRATE
### I II 4/25/1994 NOVOPHARM LTD RANITIDINE HYDROCHLORIDE USP
### I II 4/26/1994 SERIPHARM SA FACILITIES AND PROCEDURES IN LE MANS,
FRANCE
### I III 4/26/1994 ALCO CHEMICAL DIV NATIONAL STARCH ALCOGUM 9710
AND CHEMICAL CO
### I II 4/2/1994 SEAC FACILITY AND OPERATING PROCEDURES IN
BEUVRY-LA-FORET, FRANCE
### I II 5/3/1994 WYCKOFF CHEMICAL CO INC ASTEMIZOLE
### I II 4/29/1994 JANSSEN PHARMACEUTICA NV FACILITIES AND OPERATING PROCEDURES IN
THE CHEMICAL PILOT PLANT, BEERSE, BELGIUM
Page 351
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 7/1/1994 ZELLER PLASTIK GMBH G SITE, FACILITIES, OPERATING PROCEDURES
AND PERSONNEL AT ZELL/MOSEL, FEDERAL
REPUBLIC OF GERMANY
### A II 7/8/1994 TOKYO CHEMICAL INDUSTRY CO LTD TROPICAMIDE USP
### A II 7/11/1994 UNION QUIMICO FARMACEUTICA SA CIMETIDINE USP
(UQUIFA SA)
### I II 7/12/1994 ACCUCAPS INDUSTRIES LTD G. FACILITIES, PERSONNEL AND GENERAL
OPERATING PROCEDURES AT WINDSOR,
ONTARIO
### A III 6/27/1994 AKCROS CHEMICALS INC INTERSTAB HEAT AND LIGHT STABILIZERS
### A III 7/8/1994 KARL HOLL GMBH AND CO KG ALUMINIUM AND LAMINATE TUBES
### I II 7/18/1994 JANSSEN PHARMACEUTICA NV INTERMEDIATE T001349
### I II 7/18/1994 JANSSEN PHARMACEUTICA NV INTERMEDIATE T000425
### I II 7/19/1994 SIANG TA PHARMACEUTICAL CO LTD GUAIFENESIN
### I II 7/15/1994 HEUMANN PHARMA GMBH AND CO RANITIDINE HYDROCHLORIDE-FORM 1
### I I 7/20/1994 SPIRIG AG MANUFACTURING FACILITIES, PERSONNEL AND
GENERAL OPERATING PROCEDURES IN
EGERKINGEN, SWITZERLAND
### A II 7/14/1994 PHOSPHOLIPID GMBH PHOSPHOLIPON 90 H
### I II 7/14/1994 PHOSPHOLIPID GMBH PHOSAL 50 PG
### I III 7/15/1994 CARCANO ANTONIO SPA PACKAGING MATERIALS FOR SUPPOSITORIES
### A II 7/19/1994 OLON SPA BUMETANIDE
### I II 7/21/1994 JANSSEN PHARMACEUTICA NV LEVAMISOLE HYDROCHLORIDE CRUDE
### I II 7/21/1994 GENZYME CORP 5-METHYLSULFONAMIDOINDOLE-2-CARBOXYLIC
ACID
### I III 7/22/1994 TUBENFABRIK BISCHOFSZELL ALUMINUM DRUG PACKAGE MATERIALS
### I II 8/25/1994 SIGNA SA DE CV RANITIDINE HCL USP
### I III 5/9/1994 BASF AKTIENGESELLSCHAFT STYROLUX 637 D
11000 I II 7/25/1994 SANOFI RECHERCHE MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN TOULOUSE, FRANCE.
11001 A III 7/26/1994 NIPRO PHARMAPACKAGING GERMANY ARTICLES OF TUBULAR GLASS
GMBH
11002 I I 7/22/1994 SANDOZ LTD MANUFACTURING FACILITIES, PERSONENEL,
AND GENERAL OPERATING PROCEDURES IN
CO. CORK, IRELAND.
11003 I III 7/25/1994 DSM POLYMERS STAMYLEX 2H 438
11004 A II 7/21/1994 PROCOS SPA EMBUTRAMIDE
11005 I III 7/1/1994 TOYO ALUMINIUM KK FILM PACKAGING MATERIAL: PET, LDPE
REVERSE PRINTED WHITE, ALUMINUM FOIL,
ADHESIVE AND ACRYLONITRILE FILM
11006 I III 7/29/1994 REXAM MEDICAL PACKAGING INC ECDEL LAYFLAT FILM
11007 I II 7/28/1994 BIO PHARMACEUTICAL MANUFACTURING SITE, FACILITIES, OPERATING
PHARMACEUTICS SERVICES INC DIV PROCEDURES AND PERSONNEL AT FORT
IBAH INC WASHINGTON, PA
Page 352
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11008 A II 7/26/1994 ORGAPHARM HEMATOPORPHYRIN DIHYDROCHLORIDE
11009 I III 8/2/1994 PMS CONSOLIDATED COLORANT-061233CMBR,USED IN PLASTIC
PACKAGING MATERIALS
11010 A III 7/25/1994 SGD SA GLASS II CONTAINERS
11011 I I 7/28/1994 VERDUGT B V MANUFACTURING FACILITIES OPERATING
PROCEDURES AND PERSONNEL IN TIEL,
NETHERLAND
11012 I III 7/27/1994 RESCO COLOURS INC BLUE WHITE MASTERBATCH 01EHD-261
11013 I II 8/2/1994 JRH BIOSCIENCES RPMI 1640 MEDIUM, W/O L-GLUTAMINE AND W/O
PHENOL RED (PROD. NO. 52773)
11014 I II 7/28/1994 BIOSYNTH AG MELATONIN AND A STABILITY INDICATION ASSAY
METHOD FOR MELATONIN
11015 I II 8/2/1994 JANSSEN PHARMACEUTICA NV LEVAMISOLE DRUG SUBSTANCE
11016 I II 8/1/1994 BYK GULDEN LOMBERG CHEMISCHE ELTENAC/B 7808-020 DRUG SUBSTANCE
FABRIK GMBH
11017 I II 8/2/1994 ESTEVE QUIMICA SA OMEPRAZOLE
11018 I II 8/4/1994 TARO PHARMACEUTICAL INDUSTRIES DESOXIMETASONE
LTD
11019 A II 8/1/1994 BAYER AG ESTRONE
11020 I II 7/31/1994 DERETIL SA D(-) ALPHA PHENYLGLYCINE DANE SALT ETHYL
NPOTASSIUM
11021 I II 7/31/1994 DERETIL SA D(-) ALPHA PARAHYDROXY PHENYLGLYCINE
DANE SALT METHYL POTASSIUM
11022 I II 7/31/1994 DERETIL SA D(-) ALPHA DIHYDRO PHENYLGLYCINE DANE
SALT METHYL SODIUM
11023 A II 8/2/1994 SIEGFRIED PHARMACHEMIKALIEN DOBUTAMINE HYDROCHLORIDE
MINDEN GMBH
11024 I II 8/5/1994 CHINA CHEMICAL SYNTHESIS GLIPIZIDE
INDUSTRIAL CO LTD
11025 I II 8/4/1994 PHARM ECO LABORATORIES INC ANTIVIRAL STUDY GROUP INFORMATION TO
SUPPORT CLINICAL STUDIES
11026 I I 7/21/1994 MERIND LTD MANUFACTURING SITE, FACILITIES, OPERATING
PROCEDURES AND PERSONNEL AT BOMBAY,
INDIA
11027 I II 7/21/1994 MERIND LTD AMITRIPTYLINE HYDROCHLORIDE USP
11028 I III 8/10/1994 MITSUI CHEMICALS INC APEL RESINS FOR DRUG PACKAGING
11029 I II 8/10/1994 PVP SOCIEDADE ANONIMA PILOCARPINE NITRATE
11030 I II 7/27/1994 AVENTIS PHARMA SA HEMATOROPHYRINE
DIHYDROCHLORIDE,PACKAGED AND TESTED IN
VERTOLAYE,FRANCE
11031 I II 8/6/1994 TAKASAGO INTERNATIONAL CORP MANUFACTURING SITE, FACILITIES, OPERATING
PROCEDURES AND PERSONNEL IN SHIZUOKA
PREFECTURE, JAPAN
11032 I II 8/6/1994 TAKASAGO INTERNATIONAL CORP A88820.605
Page 353
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11033 I III 8/15/1994 MULLER PACKAGING LTD COATED METAL CONTAINERS, CONICAL STEEL
DRUMS
11034 I III 8/11/1994 EK PACK FOLIEN GMBH EK-MINIUM S PAP 50 GMS - PE 12 MY - ALU 12
MY - SURLYN 30 GMS; PHARMACEUTICAL
COMPONENT/PHARMACEUTICAL INTERMEDIATE
Page 354
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11060 I II 9/2/1994 SUD CHEMIE GROUP BUSINESS UNIT QUATERNIUM-18 BENTONITE (BULK)
RHEOLOGY
11061 I II 9/2/1994 PFANSTIEHL LABORATORIES INC -A,A-TREHALOSE DIHYDRATE, LOW ENDOTOXIN
11062 I III 9/2/1994 OBRIST OVERSEAS LTD COLLAPSIBLE ALUMINUM TUBES FOR CREAM &
OINTMENTS
11063 I II 9/2/1994 PHARM ECO LABORATORIES INC (S)-N-[2-OXO-2-(3,4,5-TRIMETHOXYPHENYL)
ACETYL]PIPERIDINE-2-CARBOXYLIC ACID 1,7-
BIS(3-PYRIDYL)-4-HEPTYL ESTER DICITRATE
SALT
11064 I III 8/29/1994 WINPAK TECHNOLOGIES INC TRANSDERMAL PATCH PRODUCT
11066 I II 9/2/1994 JOHNSON MATTHEY INC NAPHAZOLINE HYDROCHLORIDE
11068 I III 9/2/1994 MITSUI PETROCHEMICAL AMERICA LTD ADMER QF550E AND SF710
11069 I II 9/8/1994 AMINO GMBH BETAINE, MONOHYDRATE
11070 I IV 8/30/1994 BASF SE KOLLIDON 17 PF
11071 I III 8/18/1994 BASF AKTIENGESELLSCHAFT TERLURAN 967 K
11072 I IV 9/2/1994 NP PHARMACEUTICAL SA SUGAR SPHERES (NEUTRAL PELLETS)
11073 I IV 9/7/1994 ELF ATOCHEM NORTH AMERICA INC FORANES, F11, F12, AND F114
11074 I III 8/24/1994 CREST FLEXIBLE PACKAGING LTD PACKAGING MATERIALS FOR MEDICAL
PACKAGING (PAPER/PE/FOIL/MEL 850) 40.0G/M2
PAPER
11075 I II 9/13/1994 PURAC BIOCHEM BV AMMONIUM LACTATE, PURASAL NH 70
11076 I II 9/13/1994 LAEVOSAN GMBH AND CO KG HETASTARCH FOR INJECTION
11077 I II 9/9/1994 TANABE SEIYAKU CO LTD DILTIAZEM MALATE
11078 A II 9/10/1994 BACHEM AMERICAS INC OVINE CORTICOTROPIN RELEASING FACTOR
(0CRF)
11079 A II 9/8/1994 AMINO GMBH BETAINE
11080 I II 9/14/1994 ASAHI CHEMICAL INDUSTRY CO LTD 7-AMINOCEPHALOSPORANIC ACID (7-ACA)
FINE CHEMICALS DIV
11081 I II 9/3/1994 SUMIKA FINE CHEMICALS CO LTD CHLORPHENESIN CARBAMATE
11082 I II 9/1/1994 KANEKA CORPORATION JAPAN N2-[1-(S)-ETHOXYCARBONYL 1-3-
PHENYLPROPYL]-N6-TRIFLUOROACETYL-L-
LYSYL-L-PROLINE.
11083 I II 9/15/1994 SOCHINAZ SA DOBUTAMINE HCL
11084 A III 8/26/1994 VISCOUNT PLASTICS AUSTRALIA PTY POLYPROPYLENE VIALS
LTD
11085 I II 9/14/1994 ABBOTT LABORATORIES AMRINONE
11086 I II 9/16/1994 ALLERGAN INC MANUFACTURING SITE, FACILITIES,
PERSONNEL AND GENERAL OPERATING
PROCEDURES IN WACO, TEXAS.
11087 I II 9/16/1994 FINE ORGANICS LTD TVA
11088 I II 9/16/1994 WYCKOFF CHEMICAL CO INC 5-HYDROXYMETHYLTHIAZOLE-4-
NITROPHENYLCARBONATE HYDROCHLORIDE
11089 I II 9/16/1994 SANOFI SYNTHELABO INC ISOETHARINE MESYLATE AND ISOETHARINE
HYDROCHLORIDE
Page 355
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11090 A IV 9/19/1994 QUALICAPS EUROPE SAU EMPTY GELATIN CAPSULES
11091 I II 9/13/1994 CHEMIE LINZ GMBH N-(PHENOXYCARBONYL)-L-VALINE METHYL
ESTER
11092 I II 9/20/1994 SOCIETE INDUSTRIELLE DES MANUFACTURING SITE, FACILITIES,
OLEAGINEUX PERSONNEL AND GENERAL OPERATING
PROCEDURES
11093 I III 9/9/1994 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMULATON N4013-45 RED
11094 A III 9/12/1994 UNITED CLOSURES AND PLASTICS LTD PP28 TAMPER-EVIDENT CLICLOC III CLOSURE
11095 I II 9/14/1994 ASAHI CHEMICAL INDUSTRY CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL AND GENERAL OPERATING
PROCEDURE IN HOKKAIDO, JAPAN.
11096 I III 9/22/1994 3M PHARMACEUTICALS MSX 1154P 28% EVA COTRAN CONTROLLED
CALIPER FILM
11097 A II 9/23/1994 ALBEMARLE CORP DIPHENHYDRAMINE CITRATE, USP
11098 I II 9/26/1994 SANDOZ LTD PHARMACEUTICAL DIV CLOZAPINE
CHEMICAL DEVELOPMENT
11099 I II 9/28/1994 SEPRACOR INC (S)-KETOPROFEN
11100 I II 9/8/1994 WHATMAN EXPRESS-ION EXCHANGER C (CARBOXYETHYL
CELLULOSE)
11101 I II 9/8/1994 WHATMAN EXPRESS-ION EXCHANGER S (SULPHOXYETHYL
CELLULOSE)
11102 I II 9/8/1994 WHATMAN EXPRESS-ION EXCHANGER D
(DIETHYLAMINOETHYL CELLULOSE)
11103 I II 9/8/1994 WHATMAN EXPRESS-ION EXCHANGER Q (QUATERNARY
AMMONIUM CELLULOSE)
11104 I II 9/28/1994 SIEGFRIED LTD SELEGILINE HYDROCHLORIDE
11105 A II 9/26/1994 ZACH SYSTEM SA LOTEPREDNOL ETABONATE
11106 I IV 9/30/1994 3M PHARMACEUTICALS CHLOROFLUOROCARBON PROPELLANT P-11
(TRICHLOROFLUOROMETHANE, NF)
11107 I IV 9/30/1994 3M PHARMACEUTICALS CHLOROFLUOROCARBON PROPELLANT P-12
(DICHLOROFLUOROMETHANE,NF)
11108 I IV 9/30/1994 3M PHARMACEUTICALS CHLOROFLUOROCARBON PROPELLANT P-114
(1,2-DICHLOROTETRAFLUOROETHAN,NF)
11109 I II 9/29/1994 FINE ORGANICS LTD AOC (ACETOXY ACID GR148460X)
11110 I II 9/30/1994 BACHEM INC GLUCAGON-LIKE PEPTIDE (7-37)
11111 A IV 9/29/1994 DDP SPECIALTY ELECTRONIC SILASTIC™ QCF7-4910 UNFILLED ELASTOMER
MATERIALS US 9 LLC
11112 I III 10/3/1994 BELL FIBRE PRODUCTS CORP PRODUCT SPEC. AND TOXICITY TESTS "RVCY
700 RIGILAM BC HIPS"
11114 I III 8/31/1994 ALUMINUM CO AMERICA PHARM 9502
11115 I II 9/30/1994 WYCKOFF CHEMICAL CO INC SELEGIINE
11116 I III 8/27/1994 VAN LEER VERPACKUNGEN GMBH FIBRE DRUMS
11117 I III 9/20/1994 REXHAM CONTAINERS P&G 100CT HDPE BOTTLES
11118 I III 9/21/1994 LOCTITE INTERNATIONAL LOCTITE 408
Page 356
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11119 I II 9/21/1994 LONZA LTD NIACINAMIDE
11120 I I 9/29/1994 ZENECA PHARMACEUTICALS DIV G. SITE, FACILITIES, PERSONNEL & GENERAL
ZENECA INC OPERATING PROCEDURES IN PLANKSTADT,
GERMANY
11121 I III 9/28/1994 APTAR FRANCE SAS APTAR GASKETS
11122 I II 9/30/1994 DSM ANDENO GMBH R(-)-2-PHENYLGLYCINE DANE SALT
(POTASSIUM, ETHYL) (KE)
11123 I II 9/30/1994 DSM ANDENO GMBH R (-)-2-4-HYDROXY-PHENYLGLYCINE DANE SALT
(POTASSIUM , METHYL) (DP)
11124 A IV 9/23/1994 AKZO NOBEL SURFACE CHEMISTRY LLC ALCOGUM(R) SP
Page 357
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11143 I II 10/20/1994 PURETEK CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL & GENERAL OPERATING
PROCEDURES IN SAN FERNANDO,CA.
11144 I II 10/21/1994 ABBOTT LABORATORIES ATRACURIUM BESYLATE
11145 I III 10/13/1994 JAMES RIVER CORP DIV BERLIN DUNCOTE II HG 605/260
GORHAM GROUP
11146 A III 10/7/1994 CODING PRODUCTS TTR-5640 THERMAL TRANSFER INK RIBBON
11147 A III 10/7/1994 CODING PRODUCTS TTR-5940 THERMAL TRANSFER INK RIBBON
11148 A II 10/21/1994 FERMION OY BUSPIRONE HYDROCHLORIDE
11149 I II 10/19/1994 KOKEN CO LTD CERAMIC HYDROXYAPATITE
11150 I II 10/20/1994 ARENOL CHEMICAL CORP MAGNESIUM SALICYLATE USP
11151 I II 10/14/1994 MITSUI PETROCHEMICAL INDUSTRIES PP J858T
LTD
11152 I III 10/17/1994 COLORS FOR PLASTICS INC ACPP-10371 COLORANT
11153 I III 10/17/1994 COLORS FOR PLASTICS INC ACPP-10378 COLORANT
11154 I III 10/17/1994 COLORS FOR PLASTICS INC ACPP-40544 COLORANT
11155 A II 10/24/1994 AJINOMOTO CO INC A-4166
11156 I II 10/24/1994 DSM PHARMA CHEMICALS SOUTH OXAPROZIN
HAVEN INC
11157 A III 10/15/1994 ARTE CORP DUAL CHAMBER PREFILLABLE SYRINGE
11158 I II 10/15/1994 ARTE CORP MANUFACTURING SITE,FACILITIES,PERSONNEL
AND GENERAL OPERATING PROCEDURES IN
IBARAKI PREFECTURE, JAPAN.
11159 A III 9/1/1994 NIPRO CORP ELASTOMERIC CLOSURES
11160 I III 10/17/1994 EI DUPONT DE NEMOURS AND CO INC ZYTEL 101L NC010
11161 I II 10/24/1994 MERCK RESEARCH LABORATORIES DIV DILTIAZEM ER TABLETS
MERCK AND CO INC
11162 I III 10/11/1994 MITSUI CHEMICALS INC HZ 1300J
11163 A II 10/26/1994 CORDEN PHARMA BERGAMO SPA SULFASALAZINE
11164 I III 10/19/1994 AMPACET CORP 11416 WHITE POLYETHYLENE MASTERBATCH
11165 A IV 10/26/1994 QUALICAPS INC EMPTY GELATIN CAPSULES
11166 I II 10/12/1994 ZAMBON GROUP SPA ANA 756
11167 I II 10/26/1994 SINTESIS QUIMICA SA 6-AMINOPENICILLANIC ACID
11168 I III 10/21/1994 ECP ENICHEM POLYMERES FRANCE FLEXIRENE MS20
11169 I I 10/28/1994 ZENECA LTD MANUFACTURING SITE,FACILITIES,PERSONNEL
& GENERAL OPERATING PROCEDURES OF THE
PARENTERAL
11170 I II 10/28/1994 MERCK RESEARCH LABORATORIES DIV ENALAPRIL MALEATE & DILTIAZEM ER TABLETS
MERCK AND CO INC
11171 A II 10/31/1994 CADILA PHARMACEUTICALS LTD ETHAMBUTOL HYDROCHLORIDE USP
11172 I I 10/28/1994 ZENECA LTD MANUFACTURING SITE, FACILITY, PERSONNEL
AND GENERAL OPERATING PROCEDURES OF
THE GOSERELIN BULK DRUG PLANT IN
MACCLESFIELD, CHESHIRE, U.K.
Page 358
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11173 I III 10/14/1994 WHEATON PHARMATECH RUBBER CLOSURE FORMULATION B5006-50
BLACK
11174 I I 10/28/1994 ZENECA LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL AND GENERAL OPERATING
PROCEDURES FOR THE STERILE PRODUCT
PLANT IN MACCLESFIELD, CHESHIRE UK.
11175 I III 11/2/1994 NASHUA CORP PBL-3
11176 I II 10/31/1994 PHARMACEUTICAL MANUFACTURING MANUFACTURING SITE,FACILITIES,PERSONNEL
RESEARCH SERVICES INC & GENERAL OPERATING PROCEDURES IN
HORSHAM, PA.
11177 I II 10/31/1994 ARENOL CHEMICAL CORP COPPER GLYCINATE MONOHYDRATE
11178 I III 10/28/1994 BASF AKTIENGESELLSCHAFT STYROLUX KR 2691
11179 I II 11/4/1994 HOECHST CELANESE CORP GLYBURIDE
11180 I II 10/28/1994 KANEKA AMERICA LLC UBIDECARENONE
11181 I II 10/28/1994 KANEKA CORPORATION JAPAN MANUFACTURING SITE, FACILITIES,
PERSONNEL AND GENERAL OPERATING
PROCEDURES AT TAKASAGO-SHI HYOGO,
JAPAN
11182 I II 11/4/1994 PFANSTIEHL LABORATORIES INC PHOSPHOLIPIDS, EGG
11183 I II 11/8/1994 CILAG AG IRI -695
11184 I III 10/27/1994 INDUSTRIAL GOMERA SA DE CV BUTYL STOPPER COMPOUND
11185 I III 11/11/1994 DAK AMERICAS MISSISSIPPI INC PERMACLEAR POLYETHYLENE
TEREPHTHALATE
11186 A III 10/12/1994 CLARIANT PLASTICS AND COATINGS LICOCENE PP 6102
NORDIC AB
11187 I III 11/4/1994 ELM PLASTIC GMBH DOSING PIPETTES
11188 A III 11/5/1994 TAISEI KAKO CO LTD CONTAINERS FOR PULMONARY,NASAL,ORAL,
THROAT,SUBLINGUAL OR EAR
11189 A III 10/31/1994 INTRAPAC INDIANA INC LAMINATE TUBES
11190 I III 11/4/1994 ALUMINUM CO AMERICA PHAR 9503
11191 I II 11/14/1994 BURROUGHS WELLCOME CO MANUFACTURING SITE, FACILITIES,PERSONNEL
AND GENERAL OPERATING PROCEDURES IN
GREENVILLE, NORTH CAROLINA.
11192 I II 11/12/1994 SYNCHEM CHEMICALS PRIVATE LTD NADOLOL
11193 I III 11/7/1994 VALSPAR CORP TPL-301 CLEAR COATING
11194 A II 11/9/1994 WAVELENGTH ENTERPRISES LTD FENOFIBRATE
11195 A II 11/16/1994 SHANGHAI ZHONGXI SUNVE CLOZAPINE
PHARMACEUTICAL CO LTD
11196 I II 11/14/1994 NORDIC SYNTHESIS AB BUPROPION HYDROCHLORIDE
11197 I II 11/11/1994 DEGUSSA AG WERK RADEBEUL MANUFACTURING SITE,FACILITIES,PERSONNEL
AND GENERAL OPERATING PROCEDURES IN
WEISSENBORN, GERMANY.
11198 A IV 11/11/1994 JRS PHARMA GMBH AND CO KG UNITAB, MICROCRYSTALLINE CELLULOSE
Page 359
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11199 I I 10/24/1994 INPAC AB MANUFACTURING SITE, FACILITIES,
PERSONNEL AND GENERAL OPERATING
PROCEDURES IN LUND, SWEDEN.
11200 A II 11/15/1994 JOHNSON MATTHEY INC FENTANYL HYDROCHLORIDE
PHARMACEUTICAL MATERIALS
11201 I III 11/11/1994 AMPACET CORP 110406 WHITE POLYPROPYLENE MASTERBATCH
Page 360
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11223 I II 12/5/1994 ROQUETTE FRERES MANUFACTURING SITE,FACILITIES,PERSONNEL
AND GENERAL OPERATING PROCEDURES IN
LESTREM,FRANCE.
11224 I IV 11/30/1994 HENRY H OTTENS MANUFACTURING CO SPRAY DRIED ARTIFICIAL STRAWBERRY OIL S-
INC 464
11225 I II 11/29/1994 PHARM ECO LABORATORIES INC (3)-TETRAHYDRO-3-FURYL-N-[91S,2R)-3-2-
HYDROSYPROPYL]CARBAMATE MESYLATE
11226 I II 11/28/1994 BAUSCH AND LOMB PHARMACEUTICALS MANUFACTURING SITE,FACILITIES,PERSONNEL
INC AND GENERAL OPERATING PROCEDURES IN
TAMPA,FLORIDA.
11227 I II 12/1/1994 MALLINCKRODT CHEMICAL INC SODIUM HYDROGEN L-TARTRATE
11228 I II 12/16/1994 BORYUNG PHARMACEUTICAL CO LTD CAPTOPRIL
11229 A II 11/15/1994 RELIABLE BIOPHARMACEUTICAL LLC ETOMIDATE
11230 I II 11/28/1994 ECP ENICHEM POLYMERES FRANCE RIBLENE MR10
11231 I II 11/29/1994 METRICS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL AND GENERAL OPERATING
PROCEDURES IN GREENVILLE, NORTH
CAROLINA
11232 I II 12/1/1994 RHONE POULENC CHIMIE SALICYLIC ACID
11233 I II 12/5/1994 DS PHARMA ANIMAL HEALTH CO LTD ORBIFLOXACIN
11234 A III 11/28/1994 BPREX HEALTHCARE OFFRANVILLE SAS THERMO-PLASTIC MATERIALS
Page 363
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11302 I II 1/16/1995 CHIRON MIMOTOPES PEPTIDE CT-112
SYSTEMS
11303 I II 12/30/1994 GUANGDONG PHARMACEUTICAL ECONAZOLE NITRATE
FACTORY
11304 I IV 1/12/1995 F AND C WILD FLAVORS INC ARTIFICIAL PUNCH FLAVOR #FAAF896
11305 I II 1/17/1995 SAMHWA LUBE OIL CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN KANGWON PROVINCE, SOUTH
KOREA.
11306 I III 1/19/1995 WINPAK TECHNOLOGIES INC VAGISTAT POUCHES
11307 I V 12/7/1994 APP PHARMACEUTICALS LLC TERMINAL STERILIZATION PROGRAM IN GRAND
ISLAND, NEW YORK.
11308 A II 1/18/1995 KATWIJK CHEMIE BV OXAPROZIN
11309 I II 1/11/1995 BRECON PHARMACEUTICALS LTD MANUFACTURING SITE, FACILITIES,
PERESONNEL, AND GENERAL OPERATING
PROCEDURES IN HEREFORD, ENGLAND.
11310 I III 1/20/1995 HENKEL CORP TPX 16-159
11311 I IV 1/25/1995 GENZYME PHARMACEUTICALS LLC N-(CARBONYL-METHOXYPOLYETHYLENE
GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-
PHOSPHOETHANOLAMINE SODIUM SALT
(MPEG-DSPE)
11312 I III 1/9/1995 SONOCO PRODUCTS CO SPC-TM-506
11313 I III 1/20/1995 RESCO COLOURS INC O6EHD-895 (AMBER CONCENTRATE)
11314 I II 12/31/1994 SAFC BIOSCIENCES INC EX-CELL 405 WITH L-GLUTAMINE
11315 A II 1/26/1995 FERMION OY FLUOXETINE HYDROCHLORIDE USP
11316 I II 1/25/1995 FUJI PHOTO FILM CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
11317 I II 1/25/1995 FUJI PHOTO FILM CO LTD FP-21399
11318 I II 1/13/1995 SUPERFOS PACKAGING A S MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES.
11319 I II 1/20/1995 KYOWA HAKKO KIRIN CO LTD UCN-01 (KW-2401) BULK SUBSTANCE
11320 I IV 1/20/1995 DAVID MICHAEL AND CO INC ARTIFICIAL CHERRY FLAVOR 13233
11321 A III 1/15/1995 STEVANATO GROUP SPA GLASSWARE CONTAINERS FOR
PHARMACEUTICAL USAGE
11322 A III 2/2/1995 ALUBERG SPA LACQUERED ALUMINUM FOIL DRUG PACKAGING
MATERIALS
11323 I I 1/31/1995 SM ORGANICS PRIVATE LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN HARYANA, INDIA.
11324 I II 1/26/1995 CALBIOCHEM NOVABIOCHEM AG MANUFACTURING SITE,
FACILITIES,PERSONNEL, AND GENERAL
OPERATING PROCEDURES IN LAUFELFINGEN,
SWITZERLAND.
Page 364
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11325 A III 1/24/1995 CODING PRODUCTS SV-11618, A HOT STAMP INK RIBBON
11326 A III 1/24/1995 CODING PRODUCTS SV-11521 A HOT STAMP INK RIBBON
11327 I II 2/6/1995 JANSSEN PHARMACEUTICA NV SUFENTANIL CITRATE
11328 I II 2/7/1995 SP PHARMACEUTICALS LLC 9-AMINOCAMPTOTHECIN COLLOIDAL
DISPERSION AND DILUENT
11329 I III 1/31/1995 CREST FLEXIBLE PACKAGING LTD PACKAGING MATERIALS FOR MEDICAL
PACKAGING (PET/FOIL/PE)
11330 I III 1/27/1995 PCD POLYMERE GMBH POLYPROPYLENE GRADE DAPLEN MSC 3006 A
11331 I II 1/16/1995 BK LADENBURG GMBH PHOSKADENT SF-SODIUM FLUORIDE
11332 I III 1/27/1995 PCD POLYMERE GMBH POLYPROPYLENE GRADE DAPLEN CHC 3007
11333 I III 1/27/1995 PCD POLYMERE GMBH POLYPROPLYENE GRADE DAPLEN COD 9007
11334 I III 1/27/1995 PCD POLYMERE GMBH POLYPROPYLENE GRADE DAPLEN MOC 9006 A
11335 I II 2/7/1995 PHARMACIA AND UPJOHN 9-AMINOCAMPTOTHECIN A DRUG SUBSTANCE
11336 I II 12/2/1996 ANTIBIOTIC CO LOVASTATIN
11337 I II 2/3/1995 JANSSEN PHARMACEUTICA NV ALFENTANIL HYDROCHLORIDE
11338 A II 2/10/1995 DELTA SYNTHETIC CO LTD LIDOCAINE HYDROCHLORIDE
11339 A II 2/10/1995 DELTA SYNTHETIC CO LTD LIDOCAINE
11340 A II 2/9/1995 SAFC INC 19-NOR-1A, 25-DIHYDROXY VITAMIN D2
11341 I I 2/9/1995 TETRIONICS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MADISON, WI.
11342 A V 2/13/1995 FRESENIUS KABI USA LLC MANUFACTURING FACILITY IN MELROSE PARK,
IL
11343 I II 2/14/1995 ELF ATOCHEM MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ALONSOTEGUI, SPAIN.
11344 I II 2/14/1995 ELF ATOCHEM MANUFACTURING SITE,
FACILITIES,PERSONNEL, AND GENERAL
OPERATING PROCEDURES IN PIERRE-BENITE,
FRANCE.
11345 A II 2/10/1995 SPECGX LLC MEPERIDINE HYDROCHLORIDE, USP
11346 I II 2/13/1995 ARAB MEDICAL CONTAINERS CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SAHAB, JORDAN.
11347 I II 2/10/1995 HEUMANN PHARMA GMBH AND CO MANUFACTURING SITE, PERSONNEL,
FACILITIES, AND GENERAL OPERATING
PROCEDURES IN FEUCHT, GERMANY.
11348 I II 2/13/1995 PROMETIC BIOSCIENCES LTD MIMETIC GREEN 1 A6XL
11349 I II 2/14/1995 BRISTOL MYERS SQUIBB CO TRIAMCINOLONE DIACETATE, STERILE
11350 I III 2/10/1995 AMPACET CORP 11898 WHITE POLYETHYLENE MASTERBATCH
11351 A II 2/17/1995 CAMBREX PROFARMACO MILANO SRL CLONAZEPAM
11352 I II 2/20/1995 LEK LJUBLJANA PHARMACEUTICAL AND ACYCLOVIR A SUBSTANCE
CHEMICAL CO
11353 I III 2/21/1995 WATSON LABORATORIES INC PACKAGING MATERIALS AS MANFACTURED IN
COPIAGUE, NY.
Page 365
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11354 I II 2/15/1995 SA ALCON COUVREUR NV MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PUURS, BELGIUM.
11355 I II 2/22/1995 RTI INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SALEM, NEW JERSEY.
11356 I II 2/20/1995 RESOLUTION CHEMICALS LTD SELEGILINE HYDROCHLORIDE
11357 I III 2/13/1995 SOLVAY AND CIE SA HIGH DENSITY POLYETHYNE ELTEX B3002/33
11358 I II 2/23/1995 BIO INTERMEDIAIR BV MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN GRONINGEN, THE
NETHERLANDS.
11359 A II 2/20/1995 AMSA SPA ETODOLAC
11360 I III 2/22/1995 ELM PLASTIC GMBH MEASURING DISHES
11361 I III 2/9/1995 SENSORMATIC ELECTRONICS CORP OUTLOOK FILM #71WX38
11362 I III 2/22/1995 TUREX INC LD-640N
11363 I II 2/27/1995 BIOSEPRA INC PROTEIN A-HYPER D.
11364 A IV 3/2/1995 SYMRISE INC MICROSEAL NATURAL AND ARTIFICIAL ORANGE
FLAVOR 9/79J839
11365 I II 2/23/1995 HOSPIRA INC CLEVIDIPINE EMULSION
11366 I IV 2/28/1995 KYOWA HAKKO KOGYO CO LTD SODIUM HYALURONATE
11367 I II 3/1/1995 POWDERSIZE INC CONTRACT MICRONIZATION SERVICES
LOCATED IN QUAKERTOWN, PA.
11368 A III 2/24/1995 AMPACET CORP 110080 WHITE POLYETHYLENE MASTERBATCH
11369 A III 2/15/1995 PLASTIQUE MICRON INC PLASTIC CONTAINERS
11370 I IV 2/28/1995 J MANHEIMER INC NATURAL AND ARTIFICIAL GRAPE FLAVOR
522463
11371 I II 3/9/1995 TORPHARM INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN ONTARIO, CANADA.
11372 I V 3/9/1995 PHARMACO LIFE SCIENCE RESEARCH METHOD VALIDATION, GC/MS ANALYSIS OF
TRINITROGLYCERIN, 1,2, DINITROGLYCERIN
AND 1,3 DINITROGLYCERIN IN HUMAN PLASMA,
METHOD MS42.1
11373 A II 3/6/1995 NOVACYL SAS ASPIRIN
11374 I II 3/3/1995 OMNICHEM SA BOC CORE SUCCINATE A88820.605
11375 A IV 3/9/1995 WACKER CHEMIE AG GAMMA CYCLODEXTRIN
11376 I II 3/10/1995 BUNDER GLAS GMBH MANUFACTURING SITE, FACILITIES,
PERSONNEL AND GENERAL OPERATING
PROCEDURES IN BUNDE, GERMANY
11377 I II 3/12/1995 FERMIC SA DE CV MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MEXICO, D.F., MEXICO.
11378 A II 3/16/1995 CAMBRIDGE ISOTOPE LABORATORIES 13C UREA
INC
Page 366
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11379 A II 3/13/1995 DIPHARMA FRANCIS SRL URSODEOXYCHOLIC ACID
11380 I II 3/7/1995 DIXIE CHEMICAL CO INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN PASADENA, TEXAS.
11381 I II 3/15/1995 SS ORGANICS LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SADASIVAPET MANDIA, INDIA.
11382 I III 3/6/1995 SOLVIN SA DIOFAN DS 2319 X
11383 A III 3/6/1995 SOLVIN SA DIOFAN A-736
11384 A III 3/6/1995 SOLVIN SA DIOFAN A-716
11385 I II 3/15/1995 JIANGSU TIANQING PHARMACEUTICAL FOSCARNET SODIUM
FACTORY
11386 I IV 3/8/1995 J MANHEIMER INC NATURAL ORANGE WONF 608352
11387 A II 3/15/1995 APOTEX PHARMACHEM INC WARFARIN SODIUM CLATHRATE USP
11388 I II 3/15/1995 MW ENCAP LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN WEST LOTHIAN, UNITED
KINGDOM.
11389 A II 3/17/1995 OLON SPA CICLOPIROX OLAMINE
11390 I II 3/15/1995 JANSSEN PHARMACEUTICA NV INTERMEDIATE T001310
11391 I II 3/15/1995 BACHEM FEINCHEMIKALIEN AG TEMURTIDE
11392 A III 2/1/1995 NUSSBAUM KESSWIL AG COLLAPSIBLE ALUMINUM TUBES AND PLASTIC
CLOSURES
11393 I II 3/15/1995 BOEHRINGER INGELHEIM PHARMA KG CROTAMITON
11394 I II 3/22/1995 RANBAXY LABORATORIES LTD 7-AMINO-3-CHLORO-3-CEPHEM-4-CARBONXYLIC
ACID-DRUG SUBSTANCE INTERMEDIATE
11399 I II 3/13/1995 PURITAN BENNETT CORP NITRIC OXIDE IN NITROGEN GAS MIXTURE
11400 I II 3/24/1995 SMITHKLINE BEECHAM MANUFACTURING SITE, FACILITIES,
PHARMACEUTICALS PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CUERNAVACA, MEXICO.
11401 I II 3/23/1995 UPJOHN FARMOQUIMICA SA MANUFACTURING SITE, FACILITIES,
PERSONNNEL, AND GENERAL OPERATING
PROCEDURES IN MADRID, SPAIN.
11402 I III 3/23/1995 COVESTRO LLC MAKROLON 2658-1112
11403 I V 3/27/1995 APP PHARMACEUTICALS LLC TERMINAL STERILZATION PROGRAM IN
MELROSE PARK, ILLINOIS.
11404 A III 3/15/1995 MYLAN TECHNOLOGIES INC MEDIFLEXr 1200 and MEDIFLEXr 1501
Page 367
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11405 A II 3/29/1995 ZAKLADY FARMACEUTYCZNE ETODOLAC
POLPHARMA SA
11406 I II 3/29/1995 PORTON FINE CHEMICALS LTD PROPOFOL USP
11407 I II 3/28/1995 AVANTI POLAR LIPIDS INC 1,2-DIMYRISTOYL-SN-GLYCERO-3-
PHOSPHOCHOLINE
11408 I II 3/24/1995 SAUREFABRIK SCHWEIZERHALL MANUFACTURING SITE FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES I SCHWEIZERHALLE,
SWITZERLAND.
11409 I II 3/29/1995 DSM ANDENO GMBH L-VALINE-N-(PHENOXYCARBONYL)-
METHYLESTER (VAPOX-M)
11410 I II 3/29/1995 DSM ANDENO GMBH MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN REGENSBURG, GERMANY.
11411 I II 3/28/1995 AVECIA PHARMACEUTICALS HYDROXYSULPHONE FC4010
11412 I V 3/28/1995 PHARMACO LIFE SCIENCE RESEARCH METHOD GC32,GC ANALYSIS OF SELEGILINE IN
HUMAN PLASMA AND METHOD GC33 REVISION
1, GC ANALYSIS OF AMPHETAMINE
METHAPHETAMINE AND DESMETHYSELEGILINE
IN HUMAN PLASMA
11413 I II 3/28/1995 SANOFI AVENTIS US INC MDL 101,731
11414 I IV 3/13/1995 QUEST INTERNATIONAL FLAVORS FOOD ARTIFICIAL RASPBERRY DYO4447
INGREDIENTS CO
11415 I IV 3/22/1995 QUEST INTERNATIONAL FLAVORS FOOD ARTIFICIAL STRAWBERRY FLAVOR DY04359
INGREDIENTS CO
11416 I III 3/24/1995 GERRESHEIMER BUNDE GMBH PRIMARY PACKAGING MATERIAL FOR
PHARMACEUTICAL PRODUCTS MADE FROM
TUBULAR GLASS
11417 I V 4/3/1995 KOLMI SET OY GAMMA STERILIZATION AS CARRIED OUT BY
MOLNLYCKE HEALTH CARE OY IN
ILOMANTSI,FINLAND
11418 I IV 3/27/1995 RESCO COLOURS INC ORANGE CONCENTRATE (90PPP-158)
11419 I II 3/30/1995 FINORGA SAS PHENYLOXYCARBONYL-(L)-VALINE METHYL
ESTER
11420 I II 3/31/1995 PHARM ECO LABORATORIES INC 1,4-BIS[5-(2-IMIDAZOLINYL)-2-
BENZIMIDAZOLYL]BUTANE
TETRAHYDROCHLORIDE
11421 A II 3/31/1995 SPECGX LLC NALBUPHINE HYDROCHLORIDE (LOW BETA
EPIMER) CODE 3310
11422 A II 4/4/1995 SI GROUP 2,6-DIISOPROPYPHENOL (DIP)
11423 I III 3/27/1995 RESCO COLOURS INC GREEN CONCENTRATE (50PPP-488)
11424 I III 3/27/1995 RESCO COLOURS INC YELLOW CONCENTRATE (30PPP-260)
11425 I III 3/27/1995 RESCO COLOURS INC ORANGE CONCENTRATE (90PPP-160)
11426 A II 4/3/1995 PROCOS SPA PROPAFENONE HYDROCHLORIDE
11427 A III 3/28/1995 HOSPIRA INC PC-79 HEAT SEAL ADHESIVE
Page 368
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11428 I II 4/3/1995 JANSSEN PHARMACEUTICA NV MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN OLEN, BELGIUM.
11429 I II 4/7/1995 BIOSEPRA INC LYSINE-HYPER D
11430 I IV 4/6/1995 DRAGOCO GERBERDING AND CO AG BLOOD ORANGE FLAVORING 9/028658
11431 A III 3/31/1995 MONDI KORNEUBURG GMBH ALUMINUM LAMINATE & ALUMINUM LAMINATE
POUCH
11432 I II 4/7/1995 SANKYO CO LTD CS-866 DRUG PRODUCT
11433 I II 4/7/1995 SANKYO CO LTD CS-866 DRUG SUBSTANCE
11434 I III 4/10/1995 DUOPAC PACKAGING INC ROUND AND OBLONG HDPE BOTTLES
11435 A II 4/5/1995 NTP RADIOISOTOPES LTD MOLYBDENUM-99 (FISSION)
11436 I II 4/5/1995 GRANULES INDIA LTD COMPRESSO-90-P (ACETAMINOPHEN
GRANULES 90%)
11437 I II 4/6/1995 YONEZAWA HAMARI CHEMICALS CO LTD MANUFACTURING SITE, FACILITY PERSONNEL
AND GENERAL OPERATING PROCEDURES IN
YAMAGATA, JAPAN.
11438 A II 4/11/1995 JANSSEN PHARMACEUTICA NV RISPERIDONE (R064766) DRUG SUBSTANCE
11439 I III 4/11/1995 PCD POLYMERE GMBH POLYPROPYLENE GRADE DAPLEN KFC 2004 SB
11440 I III 4/11/1995 PCD POLYMERE GMBH POLYPROPYLENE GRADE DAPLEN KFC 2208 SB
11506 I III 5/9/1995 CLARIANT CORP WLC-12486, 25/1 WHITE COLOR CONCENTRATE
Page 372
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11541 I II 5/31/1995 E PHARMA SPA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN VIA PROVINA, ITALY.
11542 I II 5/31/1995 DSM ANDENO GMBH MBT-ESTER
11543 I II 6/1/1995 MAPRIMED SA RANITIDINE HYDROCHLORIDE
11544 I II 6/2/1995 MAHARISHI AYUR VED PRODUCTS INTL MAHARISHI MARIT KALASH (MAK-4 AND MAK-5)
INC
11545 I II 6/1/1995 GREAT LAKES CHEMICAL KONSTANZ MANUFACTURING SITE, FACILITIES,
GMBH PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN KONSTANZ, GERMANY.
11546 I II 5/31/1995 DR REDDYS LABORATORIES LTD RANITIDINE
11547 I III 6/1/1995 RESCO COLOURS INC AMBER CONCENTRATE (06EDH-950)
11548 I III 6/5/1995 CLARIANT CORP RLC-14321, 25/1 PINK COLOR CONCENTRATE
11549 I II 6/9/1995 PLANTEX LTD PENTOXIFYLLINE
11550 I II 6/1/1995 XIAN PHARMACEUTICAL FACTORY DEMETHYLEPIPODOFILOX
11551 A II 6/9/1995 UNION QUIMICO FARMACEUTICA SA OMEPRAZOLE
(UQUIFA SA)
11552 I II 6/12/1995 AVANTI POLAR LIPIDS INC 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPATE
11553 I II 6/12/1995 AVANTI POLAR LIPIDS INC 1,2-DIPALMITOYL-SN-GLYCERO-3-
PHOSPHOETHANOLAMINE-N-(POLYETHYLENE
GLYCOL 5000)
11554 I II 6/12/1995 AVANTI POLAR LIPIDS INC IMARX SYNTHETIC PHOSPHOLIPID BLEND
11555 I II 6/12/1995 ORGANON NV DESOGESTREL TABLETS (75UG AND 150UG)
11556 I II 6/13/1995 SANOFI RECHERCHE MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN LABEGE CEDEX, FRANCE
11557 I III 6/9/1995 CLARIANT CORP WPC-116, 33/1 WHITE COLOR CONCENTRATE
11558 I III 6/12/1995 SCHUEPBACH AG COMPOUND PACKING MATERIAL
PAPER/ALUMINIUN/POLYETHYENE MATERIAL
#SOP 25330
11559 A III 6/8/1995 TICONA LLC HOSTAFORM ACETAL COPOLYMER
11560 I III 6/12/1995 CLARIANT CORP WPA-116B, 25/1 WHITE COLOR CONCENTRATE
11561 I II 5/31/1995 NOF CORP PURIFIED EGG YOLK PHOSPHATIDYLCHOLINE
11562 A II 6/20/1995 CORDEN PHARMA BERGAMO SPA MICONAZOLE NITRATE
11563 A II 7/6/1995 CHINOIN PHARMACEUTICAL AND DINOPROSTONE (PROSTAGLANDIN E2)
CHEMICAL WORKS PRIVATE CO LTD
11564 A II 6/5/1995 ALBEMARLE CORP LIDOCAINE USP
11565 I III 6/16/1995 STYROLUTION EUROPE GMBH POLYSTYROL 158 K KO 21 GK 00013
11566 I II 6/8/1995 SEITZ FILTER WERKE MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES FOR SEITZ MEMBRACART PS
MEMBERANE FILTER CARTRIDGES IN BAD
KREUZNACH, FEDERAL REPUBLIC OF
GERMANY.
Page 374
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11594 I II 7/20/1995 ANTIBIOTICOS MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES FOR BULK PROCESS
DEVELOPMENT IN RODANO, ITALY.
11595 A II 7/21/1995 COPPERHEAD INVESTMENTS INC NITROGLYCERIN
11596 I II 7/25/1995 ARCHIMICA SPA BULK CRUDE PROPOFOL
11597 I II 7/6/1995 PALMER RESEARCH TRIETHYL 3-BROMOPROPANE-1, 1, 1-
TRICARBOXYLATE
11598 A III 7/18/1995 CARCANO ANTONIO SPA PACKAGING MATERIAL ALUMINUM FOIL
SMOOTH, HARD OR SOFT TEMPER, .020, .025
AND .030 MM
11599 I III 8/15/1995 MONTELL SDK SUNRISE LTD SHOLEX 6002B AND SHO-ALLOMER MA 411 AND
MA 422
11600 I II 8/15/1995 ZENTIVA KS METOPROLOL SUCCINATE
11601 A IV 7/27/1995 CFC CONSORTIUM CHLOROFLUOROCARBON 11, 12, AND 114.
11602 I II 2/5/1996 UNION QUIMICO FARMACEUTICA SA CIPROFLOXACIN HYDROCHLORIDE
11603 I II 7/25/1995 SHANGHAI INDUSTRIAL CHEMICAL CO D-(-)-PHENYGLYCINE DANE SALT
LTD
11604 A III 7/18/1995 CARCANO ANTONIO SPA PACKAGING MATERIAL ALUMINUM FOIL,
SMOOTH, SOFT TEMPER, .045 AND .048MM
11605 I II 7/28/1995 HELSINN CHEMICALS SA TRAMADOL HYDROCHLORIDE
11606 A II 7/27/1995 SHANDONG XINHUA PHARMACEUTICAL HYDROCORTISONE
CO LTD
11607 A II 7/31/1995 FARMHISPANIA SA ATRACURIUM BESYLATE USP
11608 I III 7/25/1995 SUPERFOS PHARMA HD POLYETHYLENE COLOURED WHITE
BOTTLES
11609 I II 7/25/1995 LIFECORE BIOMEDICAL INC HY-50 HYALURONATE SODIUM STERILE
INJECTION
11610 I II 7/28/1995 AIR LIQUIDE AMERICA CORP 2200 PPM NITRIC OXIDE/BALANCE NITROGEN
GAS MIXTURE
11611 I III 8/2/1995 KANEKA TEXAS CORP KANE ACE B-22, B-52, B-56, AND B-522
11612 I III 8/2/1995 KANEKA TEXAS CORP KANE ACE B-22, B-52, B-56, AND B-522
11613 I III 8/2/1995 KANEKA TEXAS CORP KANE ACE B-22, B-52, B-56, AND B-522
11614 A II 7/28/1995 VETTER PHARMA FERTIGUNG GMBH STERILE WATER FOR INJECTION
AND CO KG
11615 A II 8/4/1995 BASF SE DERMAZ 88 (AZELAIC ACID)
11616 I III 9/1/1995 SONOCO FLEXIBLE PACKAGING MPE953M-3
11617 I III 8/3/1995 DSM POLYMERS STAMYLAN LD 2304A
11618 I II 8/7/1995 SANDOZ PHARMA LTD CYCLOSPORINE MANFACTURED IN BASLE,
SWITZERLAND.
11619 I II 8/9/1995 UNION QUIMICO FARMACEUTICA SA 2-ISOPROPYL-4-(N-METHYL)
AMNINOMETHYLTHIAZOLE
11620 I IV 8/8/1995 CYTRX CORP CRL-1005 (POE-POP-POE BLOCK COPOLYMER
120.5)
11621 I III 8/7/1995 HARTFORD PLASTICS HIGH-DENSITY POLYETHYLENE
Page 375
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11622 I V 7/20/1995 PHARMACO LIFE SCIENCE RESEARCH METHOD MS23.1, GC/MS ANALYSIS OF
ENALAPRIL AND ENALAPRILAT IN HUMAN URINE
11623 I V 7/20/1995 PHARMACO LIFE SCIENCE RESEARCH METHOD MS23 REVISION 1 GC/MS ANALYSIS OF
ENALAPRIL AND ENALAPRILAT IN HUMAN
PLASMA
11624 I III 8/4/1995 REXENE CORP POLYETHYLENE RESIN PE 1403
11625 I I 8/14/1995 LABORATORIOS SERONO SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN TRES CANTOS, SPAIN.
11626 I III 8/14/1995 SAMHWA LUBE OIL CO LTD LUBRICATION OILS FOR COLD ROLLING OF
ALUMINUM FOIL
11627 I II 6/4/1996 FARCHEMIA SRL NAPROXEN SODIUM USP
11628 I IV 8/11/1995 HENRY H OTTENS MANUFACTURING CO ARTIFICIAL COOLING COMPOUND #6883
INC
11629 I II 8/17/1995 DEGUSSA AG WERK RADEBEUL MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CISPLATIN USP IN HANAU,
GERMANY.
11630 I II 8/15/1995 SLOVAKOFARMA LTD METOPROLOL TARTRATE
11631 I II 8/23/1995 SHANGHAI NUMBER 6 PRAZIQUANTEL
PHARMACEUTICAL FACTORY
11632 I II 8/23/1995 TIANJIN HEBEI PHARMACEUTICAL MANUFACTURING SITE, FACILITIES,
FACTORY PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN TIANJIN, CHINA.
11633 I II 8/25/1995 CALAIRE CHIMIE SAS MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN CEDEX, FRANCE.
11634 I III 8/7/1995 FLINT HILLS RESOURCES LP POLYPROPYLENE RESIN PP 6310
11635 I II 8/31/1995 UCB INC METHYLPHENIDATE HYDROCHLORIDE, USP
11636 I II 8/30/1995 MALLINCKRODT INC MEPERIDINE HYDROCHLORIDE INJECTION USP
10MG/ML
11637 I II 8/28/1995 ZENTIVA AS D,L-METIPRANOLOL
11638 I II 9/1/1995 ROCHE DIAGNOSTICS GMBH D,L-METIPRANOLOL
11639 A II 8/28/1995 NORBROOK LABORATORIES LTD PROCAINE HYDROCHLORIDE USP
11640 A III 10/9/1995 BPREX HEALTHCARE OFFRANVILLE SAS PLASTIC BOTTLE 10ML PEHD WHITE, PLASTIC
NOZZLE PELD WHITE, AND PLASTIC CAP
PELD/HD MIXING 50/50
11641 I II 9/1/1995 CELSUS LABORATORIES INC PERIODATE-OXIDIZED HEPARIN
11642 I III 8/16/1995 REXENE CORP POLYPROPYLENE RESIN PP 13T10A CS-276
11643 I II 9/13/1995 MERCK AND CO INC STERILE DILUENT
11644 I III 9/5/1995 3M HEALTH CARE LTD MSX 1174P NONWOVEN TAPE
11645 I II 9/7/1995 DSM ANDENO GMBH ASEPTIC ONCOLOGICAL FACILITY
11646 I III 9/8/1995 AMPACET CORP 10061 SLIP POLYETHYLENE MASTERBATCH
11647 I III 9/6/1995 WEST PHARMACEUTICAL SERVICES INC COUNTER CAP
Page 376
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11648 A V 9/6/1995 WEST PHARMACEUTICAL SERVICES INC WESTAR RS PROCESS
Page 377
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11674 A II 9/22/1995 PRIME EUROPEAN THERAPEUTICALS 5-THIAZOLE WING
SPA (EUTICALS SPA)
11675 I II 9/18/1995 KURITA WATER INDUSTRIES LTD KURIMOVER II
11676 I II 9/26/1995 AMOLI ORGANICS LTD DICLOFENAC SODIUM
11677 I II 9/25/1995 AJINOMOTO CO INC A-84538.0 (RITONAVIR)
11678 A IV 9/13/1995 DUPONT NUTRITION USA INC MARINE COLLOIDS CARRAGEENAN
11679 I II 9/20/1995 BOEHRINGER INGELHEIM PHARMA KG SCOPOLAMINE-N-BUTLYBROMIDE (BUSCOPAN)
11680 I II 9/27/1995 DURA PHARMACEUTICALS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SAN DIEGO, CALIFORNIA.
11681 I II 9/26/1995 AMOLI ORGANICS LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN GUJARAT, INDIA.
11682 A II 9/19/1995 PMC ISOCHEM TERTIOBUTYL-4'-CHLORO-4-BUTYROPHENONE
11683 A II 9/25/1995 COPPERHEAD INVESTMENTS INC SDM 26 (NITROGLYCERIN ON LACTOSE
MIXTURE)
11684 I III 9/22/1995 PROMEXMEDICAL INC SECONDARY PACKAGING OF BIAXIN FILMTABS
CLAIRTHROMYCIN 500MG TABLETS,
MEDISCRIPTS STARTER
11685 I II 4/20/1995 SYNTHELABO PHARMACIE UREA-CALCIUM ACETYLSALICYLATE
11686 I V 9/27/1995 VETTER PHARMA FERTIGUNG GMBH PRODUCTION OF PRE-FILLED SYRINGES AND
AND CO KG LIQUID PRODUCTS
11687 I III 9/18/1995 AMILCO SA GLASS TUBULAR CONTAINERS
11688 I II 9/29/1995 DELMAR CHEMICALS INC KETOROLAC DERIVATIVE
11689 I V 9/12/1995 EORTC NEW DRUG DEVELOPMENT STANDARD OPERATING PROCEDURES OF
OFFICE EARLY CLINICAL RESEARCH OF NEW
ANTICANCER AGENTS.
11690 I III 9/29/1995 CREST FLEXIBLE PACKAGING LTD PACKAGING MATERIALS FOR MEDICAL
PACKAGING (PAPER/PE/FOIL/MEL 850 45.0G/M2
PAPER)
11691 A III 9/29/1995 BAXTER HEALTHCARE CORP TERMINALLY STERILIZED INJECTIONS IN PL
2408 PLASTIC CONTAINER
11692 A II 10/3/1995 CAMBREX PROFARMACO MILANO SRL CLOZAPINE
11693 I II 9/29/1995 ALMEDICA EUROPE LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN DEESIDE, UNITED KINGDOM.
11694 I III 10/4/1995 COVALENCE COATED PRODUCTS PROCEDURES FOR STERILE OPERATIONS IN
CATALENT BELGIUM LOCATED IN BRUSSELS
BELGIUM
11695 I II 9/28/1995 AIR PRODUCTS AND CHEMICALS INC APF-N30 (PERFLUOROPROPANE)
11696 I IV 9/28/1995 GATTEFOSSE SAS PLUROL DIISOSTEARIQUE
11697 I II 10/3/1995 JACOBUS PHARMACEUTICAL CO AMINOSALICYLATE SODIUM USP
11698 I III 10/5/1995 YOSHINO KOUGYOUSHO CO LTD PLASTIC CONTAINER FOR WRAPPING TABLETS
11699 I II 10/4/1995 SIMS SRL FLUOXETINE HCL
11700 I II 9/30/1995 FARCHEMIA SRL DICLOFENAC SODIUM
Page 378
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11701 I V 9/28/1995 PHARMACIA AND UPJOHN STERILE PROCESSING FACILITY LOCATED IN
NERVIANO (MILAN) ITALY.
11702 A II 10/10/1995 DR REDDYS LABORATORIES LTD PERMETHRIN BPC CIS:TRANS/25:75
11703 I II 10/6/1995 CLINETICS CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN TUSTIN, CALIFORNIA
11704 A II 10/5/1995 EXCELLA GMBH AND CO KG METHOTREXATE
11705 I II 10/4/1995 AVECIA INC SDM-79 (25% NITROGLYCERIN IN SOLVATED
ADHESIVE POLYMER)
11706 I II 10/12/1995 BAYER SCHERING PHARMA AG ILOPROST B-CYCLODEXRIN CLATHRATE
11707 I III 10/13/1995 3M DRUG DELIVERY SYSTEMS DIV A66210 SPRAYMISER MK2 VALVE
11708 I III 10/11/1995 CLARIANT CORP MASTERBATCHES DIV MLC-15194 25/1 SILVER METALLIC COLOR
CONCENTRATE
11709 I II 10/2/1995 TERRY MESON TECHNOLOGY LTD STRONTIUM-82 (P:4N, 6N)
11710 A III 10/10/1995 BERRY GLOBAL POLYETHYLENE AND POLYPROPYLENE
SQUEEZE TUBES IN NATURAL OR WHITE RESIN
11711 A III 9/27/1995 TRIVENI POLYMERS PRIVATE LTD HDPE CONTAINERS
11712 I III 10/16/1995 CLARIANT CORP MASTERBATCHES DIV YLC-15218 25/1 PEARL YELLOW COLOR
CONCENTRATE
11713 I V 10/20/1995 AMERICAN PHARMACEUTICAL POWDER DRUGS IN VIALS STERILIZATION
PARTNERS INC PROCESS VALIDATION DOCUMENTATION
(ASEPTIC FILL) IN GRAND ISLAND, NEW YORK.
11714 I II 10/18/1995 BOEHRINGER INGELHEIM PHARMA KG CAMPTOTHECIN
11715 I III 10/18/1995 MAC CLOSURES INC 13-425 LINERLESS CLOSURE
11716 I III 10/16/1995 AIR PRODUCTS AND CHEMICALS INC FLEXCRYL GP5 EMULSION
11717 I IV 10/16/1995 TECHNOLOGY FLAVORS AND ARTIFICIAL STRAWBERRY FLAVOR 844-149
FRAGRANCES INC
11718 I IV 10/16/1995 TECHNOLOGY FLAVORS AND NATURAL CHERRY WONF 544-412
FRAGRANCES INC
11719 I IV 10/16/1995 TECHNOLOGY FLAVORS AND NATURAL CHERRY FLAVOR 544-411
FRAGRANCES INC
11720 I III 10/30/1995 TENAX CORP RECTAL DELIVERY SYSTEM COMPONENT
11721 I II 10/20/1995 NOVARTIS PHARMACEUTICALS CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURE IN ORLEANS-LA SOURCE,
FRANCE.
11722 A III 10/16/1995 COLORS FOR PLASTICS INC R27188
11723 I III 10/16/1995 COLORS FOR PLASTICS INC W06221
11724 I II 10/26/1995 LIPHA SAS CROMOLYN SODIUM
11725 I II 10/27/1995 MERCIAN CORP RAPAMYCIN CRUDE OIL
11726 I IV 10/27/1995 WESTERN FLAVORS AND FRAGRANCES CHERRY FLAVOR ARTIFICIAL WILD W.S. #501237
INC
Page 379
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11727 A II 10/31/1995 KOEI CHEMICAL CO LTD BOC-PIPERAZINE (S)-3-[[(1,1-DIMETHYLETHYL)
AMINO] CARBONYL] -1-
PIPERAZINECARBOXYLIC ACID 1,1-
DIMETHYLETHYL ESTER
11728 I II 1/30/1996 TAMA KAGAKU KOGYO CO LTD (-)-CIS-1-AMINOINDAN-2-01
11729 I I 9/1/1995 CAULDRON INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MALVERN, PENNSYLVANIA.
11730 I II 10/26/1995 LONZA LTD TERT-BUTYL (S)-3-(TERT-BUTYLCARBAMOYL)
PIPERAZINE-1-CARBOXYLATE
11731 I III 10/31/1995 BPREX HEALTHCARE PACKAGING INC PLASTIC CONTAINERS
DBA BERRY PLASTICS
11732 A III 10/31/1995 3M DRUG DELIVERY SYSTEMS ALUMINIUM CANISTERS
11733 I III 11/1/1995 3M DRUG DELIVERY SYSTEMS DIV A66139 50UL SPRAYMISER VALVE
11734 I II 11/16/1995 MEDEA RESEARCH LABORATORIES INC 2,5-DIMETHOXY-2-METHYL-5H-DIHYDROFURAN
11735 I I 10/20/1995 LABORATOIRES SANDOZ SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN RUEIL-MALMAISON, FRANCE.
11736 I II 11/3/1995 ABBOTT LABORATORIES CHEMICAL AND KETOROLAC TROMETHAMINE
AGRICULTURAL PRODUCTS DIV
11737 I III 11/3/1995 3M DRUG DELIVERY SYSTEMS DIV 3M SCOTCH PAK 9724 POLYESTER FILM
LAMINATE
11738 I III 11/2/1995 3M PHARMACEUTICALS 66203 63UL SPRAYMISER MK1 VALVE
11739 I III 10/31/1995 PECHINEY EMBALLAGE ALIMENTAIRE BLISTER FOIL A LACQURED ANNEALED
ALUMINIUM FOIL
11740 I II 11/6/1995 CHEMI SPA ETODOLAC
11741 I III 11/8/1995 MITSUI CHEMICALS INC HZ 5195B AND MIRASON 50
11742 A II 11/14/1995 TEVA PHARMACEUTICAL INDUSTRIES ATRACURIUM BESYLATE
LTD
11743 I II 11/9/1995 SIGMA CHEMICAL CO CHOLESTERYL ACETATE (W 5388-4)
11744 I II 11/14/1995 DSM ANDENO GMBH (-)-CIS-1-AMINOINDAN-2-OL(AMINDA)
11745 I II 11/9/1995 MORTON INTERNATIONAL INC MAGNESIUM OXIDE USP HEAVY (PRODUCT
SPECIALTY CHEMICAL GROUP CODE 6010-9)
11746 I II 11/14/1995 PHARM ECO LABORATORIES INC (S)-N-BENZYL-N-[1,5,-BIS(4-PYRIDYL)-3-PENTYL]-
3-(4CHLOROPHENYL)-2-{METHYL-[2-OXO-2-(3,4,5
TRIMETHOXYPHENYL)
11747 I II 11/13/1995 ZACH SYSTEM SPA ZALEPLON
11748 I II 11/20/1995 SUMITOMO CHEMICAL CO LTD OXAPROZIN
11749 I II 11/17/1995 HOECHST AG BULK MEPERIDINE HYDROCHLORIDE USP
(PETHIDINE HYDROCHLORIDE EP) DRUG
SUBSTANCE
11750 I II 11/16/1995 CKD BIO CORP RIFAMYCIN-S
11751 A III 8/15/1996 3M DRUG DELIVERY SYSTEMS CONTAINER CLOSURE COMPONENTS FOR
HFA134A FLUNISOLIDE METERED DOSE
INHALER (MDI)
Page 380
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11752 I III 11/20/1995 WHEATON WORLDWIDE INC PLASTIC CONTAINERS
11753 I III 11/14/1995 OY PREMIX LTD PREADD SL 101
11754 I III 11/14/1995 BASELL POLIOLEFINE ITALIA SPA LUPOLEN 5021 D
11755 I II 11/27/1995 ALDRICH PHARMACEUTICALS LTD FENBENDAZOLE
11756 I I 11/16/1995 CHONG KUN DANG CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN KYEONGKI-DO, KOREA.
11757 A II 11/9/1995 ACS DOBFAR SPA CEPHAPIRIN ACID
11758 A II 11/28/1995 APOTEX PHARMACHEM INC METHACHOLINE CHLORIDE USP
11759 A II 11/29/1995 SHIRATORI PHARMCEUTICAL CO LTD EMEDASTINE DIFUMARATE
11760 I II 11/28/1995 ARCHIMICA SPA OP 3300/15
11761 I II 12/1/1995 ASTELLAS PHARMA INC TAMSULOSIN HYDROCHLORIDE
11762 I III 11/27/1995 PROMEXMEDICAL INC SECONDARY PACKAGING OF PREVACID 15MG &
30MG CAPSULES OF LANSOPRAZOLE,
MEDISCRIPTS STARTER
11763 A III 11/23/1995 BESPAK CONSORT MEDICAL PLC BESPAK BK600 & BK700 SERIES ACTUATORS
11764 A II 12/5/1995 FINORGA SAS ZOLPIDEM TARTRATE MODIFIED SYNTHESIS
11765 A III 12/4/1995 BERRY GLOBAL CONTINUOUS THREADED CLOSURES (CTC)
11766 A II 12/11/1995 TEVA PHARMACEUTICAL INDUSTRIES ETODOLAC
LTD
11767 A II 12/6/1995 NORBROOK LABORATORIES LTD BENZOCAINE USP
11768 A II 12/7/1995 JANSSEN PHARMACEUTICA NV CISAPRIDE(R051619) DRUG SUBSTANCE
11769 I II 12/5/1995 BORON BIOLOGICALS INC DISODIUM 1-MERCAPTO-
UNDECAHYDRODODECABORATE, 10B-ERICHED
AND 1-MERCAPTO-
UNDECAHYDRODODECABORATE, NATURAL
ABUNDANCE
11770 I IV 11/30/1995 CUSTOM ESSENCE INC FRAGRANCE CE-26101
11771 I II 12/12/1995 SM ORGANICS PRIVATE LTD COLCHICINE
11772 I III 12/15/1995 SABIC PETROCHEMICALS BV SABIC LDPE 2308A
11773 I III 12/15/1995 SABIC PETROCHEMICALS BV SABIC LDPE 1922T
11774 I III 12/15/1995 DSM POLYMERS STAMYLEX 9089
11775 I III 12/15/1995 DSM POLYMERS STAMYLAN HD 9089U
11776 I IV 11/28/1995 GRAIN PROCESSING CORP SUPERABSORBENT ADDITIVES USED IN DRUG
DOSAGE FORMS
11777 A II 12/8/1995 SI GROUP PROPOFOL
11778 I III 12/11/1995 VERATEC CANADA RAYON AND COTTON PHARMACEUTICAL COIL
11779 A II 12/22/1995 OLON SPA LABETALOL HYDROCHLORIDE
11780 A II 12/24/1995 KATWIJK CHEMIE BV PEMOLINE
11781 I II 12/19/1995 WYCKOFF CHEMICAL CO INC BUTAMBEN USP
11782 I II 12/26/1995 CHISSO CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MINAMATA, JAPAN.
11783 I III 12/20/1995 FLINT HILLS RESOURCES LP POLYPROPYLENE RESIN PP 12N25A
11784 A II 12/20/1995 FIS FABBRICA ITALIANA SINTETICI SPA ESTAZOLAM
Page 381
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11785 A II 12/18/1995 SANOFI AVENTIS DEUTSCHLAND GMBH FUROSEMIDE (BULK)
11786 A II 12/24/1995 KATWIJK CHEMIE BV SODIUM VALPROATE CRYSTALS
11787 I III 12/7/1995 BASELL POLIOLEFINE ITALIA SPA LUPOLEN 5031 L
11788 I III 12/18/1995 SOLVAY SA POLYPROPYLENE ELTEX P HF100
11789 I III 12/18/1995 SOLVAY SA B55-20N0047
11790 I III 12/18/1995 SOLVAY SA HIGH DENSITY POLYETHYLENE ELTEX B3015LG
11791 I III 12/18/1995 SOLVAY SA HIGH DENSITY POLYETHYLENE ELTEX B4020LG
11792 I III 12/18/1995 SOLVAY SA HIGH DENSITY POLYETHYLENE ELTEX A4009
11793 A III 12/18/1995 SCHOTT HUNGARY KFT PRIMARY PACKAGING MATERIAL
11794 A II 12/21/1995 ESTEVE QUIMICA SA OMEPRAZOLE
11795 A III 12/27/1995 TAISEI KAKO CO LTD PLASTIC TUBES AND METAL TUBES FOR
NONPARENTERAL CONTAINERS
11796 I II 1/22/1996 DIASPA SPA RIFAMYCIN "S" BULK
11797 I IV 10/27/1995 JRS PHARMA LP NONPAREILS (SUGAR SPHERES NF)
11798 I IV 12/29/1995 MISSISSIPPI BLENDING CO INC DIRECTO PRESS NF (CORNSTARCH BLEND)
11799 I II 1/4/1996 CILAG AG KETOROLAC TROMETHAMINE
11800 I IV 12/21/1995 SENN CHEMICALS AG AA-D-TREHALOSE DIHYDRATE
11801 A II 1/10/1996 KYOWA HAKKO KIRIN CO LTD OLOPATADINE HYDROCHLORIDE (KW 4679)
11802 I II 1/5/1996 INHALE THERAPEUTICS SYSTEMS DRY POWDER AEROSOL PARATHYROID
HORMONE (PTH) DRUG PRODUCT
11803 A II 12/19/1995 QUIMICA SINTETICA SA LORATADINE
11804 I III 1/10/1996 3M PHARMACEUTICALS A66154 50UL SPRAYMISER VALVE
11805 I II 1/11/1996 SMITHKLINE BEECHAM CIMETIDINE
PHARMACEUTICALS
11806 I II 1/15/1996 ORSYMONDE MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF MODAFINIL DRUG
SUBSTANCE IN MITRY-MORY MITRY-MORY
CEDEX FRANCE.
11807 A II 1/15/1996 CORDEN PHARMA BERGAMO SPA MESALAMINE
11808 A II 1/9/1996 INTERQUIM SA SERTACONAZOLE NITRATE
11809 A II 1/15/1996 ACS DOBFAR SPA STERILE TRISODIUM CITRATE DIHYDRATE
11810 A II 1/16/1996 CHENG FONG CHEMICAL CO LTD PHENYLPROPANOLAMINE HYDROCHLORIDE
11811 A II 1/15/1996 CIPLA LTD NORFLOXACIN USP
11812 I III 1/11/1996 CARCANO ANTONIO SPA ALUMINIUM FOIL, SMOOTH, HARD TEMPER, .020
AND .025 MM LACQUERED
11813 I IV 1/15/1996 TIMERX TECHNOLOGIES TIMERX-O CONTROLLED RELEASE SYSTEM
11814 I II 1/17/1996 JANSSEN PHARMACEUTICA NV RIDOGREL DRUG SUBSTANCE
11815 I IV 12/20/1995 DAVID MICHAEL AND CO INC MICHAELOK NATURAL LEMON-LIME FLAVOR
WONF #1296
11816 I II 1/12/1996 SIGMA CHEMICAL CO CHOLESTERYL BENZOATE, STOCK NUMBER W
5389-2
11817 A III 1/18/1996 APTAR FRANCE SAS METERED DOSE VALVES
Page 382
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11818 I II 1/17/1996 MITSUI CHEMICALS INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF PLGA5 IN NAGOYA, JAPAN.
11819 A IV 1/17/1996 MITSUI CHEMICALS INC PLGA5, POLY (DL-LACTIDE-O(O-GLYCOLIDE)
11820 A III 12/22/1995 SCHOTT AG GLASS / PLASTIC VIALS
11821 A II 1/23/1996 SANOFI CHIMIE TILUDRONATE DISODIUM DRUG SUBSTANCE
11822 I I 1/15/1996 RANQ PHARMACEUTICALS AND MANUFACTURING SITE, FACILITIES,
EXCIPIENTS PVT LTD PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN MAHARASHTRA STATE, INDIA.
11823 A II 1/23/1996 ACS DOBFAR SPA CEFOXITIN ACID
11824 I II 1/25/1996 HOECHST MARION ROUSSEL INC RANITIDINE HYDROCHLORIDE USP, FORM 1
11825 I II 1/24/1996 PTI ADVANCED FILRATION INC CLARIFLOW PRODUCT LINE
11826 A II 1/3/1996 ASPEN OSS BV TESTOSTERONE
11827 I II 1/25/1996 CHEMICA INC A-PHENYL-A-(2-PYRIDYL) ACETIC ACID METHYL
ESTER
11828 A II 1/26/1996 CORDEN PHARMA BERGAMO SPA NAPROXEN USP
11829 I II 1/24/1996 FIDIA FARMACEUTICI SPA ACYCLOVIR SODIUM SALT
11830 I II 1/24/1996 LOS ALAMOS NATIONAL LABORATORY CU-67 BULK RADIOISOTOPIC PRODUCT
DEPT ENERGY
11831 I II 1/19/1996 VEREIN FUR KREBSFORSCHUNG ISCADOR QU SPEZIAL
11832 I II 1/19/1996 VEREIN FUR KREBSFORSCHUNG MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF ISCADOR QU SPEZIAL IN
ARLESHEIM, SWITZERLAND.
11833 I IV 1/19/1996 COURTAULDS CHEMICALS SEPA 0009 (2-MONYL-1,3-
DIOXACYCLOPENTANE)
11834 A II 1/29/1996 CHEMI SPA BUPROPION HYDROCHLORIDE
11835 I II 1/29/1996 ASAHI GLASS CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF BFBB
11836 I II 1/29/1996 ASAHI GLASS CO LTD BFBB
11837 A III 1/18/1996 AMPACET CORP 19574 BLACK PE MB
11838 I II 1/30/1996 YAMAKAWA CHEMICAL INDUSTRY CO BOC-PIPERAZINE
LTD
11839 I II 1/17/1996 GENPHARM INC RANITIDINE HYDROCHLORIDE USP FORM 1
11840 I I 1/15/1996 COVANCE PHARMACEUTICAL MANUFACTURING SITE, FACILITIES,
PACKAGING SERVICES INC PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF PACKAGING OF CLILNICAL
TRIALS SUPPLIES IN BASEL, SWITZERLAND.
11841 I II 1/29/1996 NAPRO BIOTHERAPEUTICS INC PACLITAXEL DRUG SUBSTANCE
11842 I II 1/26/1996 ARCHIMICA SPA SANCYCLINE
11843 I II 2/5/1996 EURAND INTERNATIONAL SPA DIFFUCAPS PSEUDOEPHEDRINE HCL BULK
PELLETS
11844 I III 10/12/1995 POLIMERI EUROPA FRANCE GREENFLEX FF 55 M (MEDICAL GRADE)
11845 I II 2/6/1996 NISSAN CHEMICAL INDUSTRIES LTD ALPROSTADIL
Page 383
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11846 I II 2/5/1996 EASTMAN CHEMICAL CO DIETHYL PHTHALATE, NF
11847 I II 2/8/1996 NORDION INTERNATIONAL INC DOPASCAN INJECTION
11848 A II 2/8/1996 PHARMACIA AND UPJOHN CO WHOLLY BETAMETHYL EPOXIDE
OWNED SUB PFIZER INC
11849 I II 2/13/1996 PHARM ECO LABORATORIES INC 2(R)-HYDROXY-3(S) BOC-AMINO-4-PHENYL-1-
AMINOBUTANE
11850 I I 2/5/1996 CIBA GEIGY CORP PHARMACEUTICALS MANUFACTURING SITE, FACILITIES,
DIV PERSONNEL, AND GENERAL OPERATING
PROCEDURES BY CIBA-GEIGY SPA IN TORRE
ANNUNIATA (NAPLES) ITALY.
11851 A III 2/16/1996 BERRY GLOBAL 41121-22
11852 I III 2/14/1996 CLARIANT CORP MASTERBATCHES DIV GLC-16004 25/1 LIME COLOR CONCENTRATE
11853 I I 3/4/1996 SEPPIC DIV AIR LIQUIDE MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN GIVAUDAN LAVIROTTE, LYON,
FRANCE.
11854 I IV 2/13/1996 SYMRISE INC CHERRY FLAVORING 9/021529
11855 I IV 2/13/1996 SYMRISE INC CHERRY FLAVORING 9/021935
11856 I II 2/19/1996 BIOSEPRA SA CM-HYPERD (10U, 20U, F AND M GRADES)
11857 I II 2/9/1996 WOODWARD IODINE CORP IODINE (USP IODINE)
11858 I III 2/14/1996 CLARIANT CORP MASTERBATCHES DIV BLC-16005 25/1 PEARL BLUE COLOR
CONCENTRATE
11859 I IV 2/16/1996 MERCK SHARP AND DOHME CORP POLYVINYL ACETATE-CROTONIC ACID
COPOLYMER
11860 I II 2/19/1996 TASMANIAN ALKALOIDS PARTY LTD BUPRENORPHINE BASE
11861 I III 2/26/1996 GRAND POLYMER CO LTD GRANDPOLYPRO F300(I) AND F305(I)
11862 I II 2/8/1996 MEDICHEM SA OXAPROZIN
11863 I II 2/14/1996 BROOKHAVEN NATIONAL LABORATORY CU-67 BULK RADIOISOTOPIC PRODUCT
11864 I II 1/1/1996 DSM DERETIL D-(-) ALPHA PHENYLGLYCINE CHLORIDE
HYDROCHLORIDE
11865 I II 2/19/1996 DUDEK PLAST AS MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN JONSTRUP, DENMARK.
11866 A II 2/27/1996 ESTEVE QUIMICA SA ENALAPRIL MALEATE
11867 I II 2/28/1996 CILAG AG OXAPROZIN
11868 A IV 2/27/1996 ENDO PHARMACEUTICALS INC TIMERX CONTROLLED RELEASE SYSTEMS
11869 I II 2/21/1996 PLASRO PLASTICS LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN SURREY, UNITED KINGDOM.
11870 A III 2/29/1996 BERRY GLOBAL 41708-34
11871 A III 2/28/1996 DESICCARE INC PACKAGING MATERIALS PILLOW PAKS
11872 I III 2/19/1996 MITSUI CHEMICALS INC MIRASON 14P
11873 I III 2/27/1996 B BRAUN MEDICAL INC QUALIFICATION AND MANUFACTURING OF
EXCEL PLASTIC IV CONTAINER
Page 384
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
11874 I II 2/28/1996 BOEHRINGER MANNHEIM SA MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES IN BARCELONA, SPAIN.
11875 I IV 2/28/1996 MARUTI INDUSTRIAL CARBOHYDRATES MICROCRYSTALLINE CELLULOSE (MCC)
LTD
11876 I II 2/28/1996 BK GIULINI GMBH SUCRALFATE POWDER
11877 A II 3/4/1996 SCI PHARMTECH INC ARTICAINE HYDROCHLORIDE DRUG
SUBSTANCE
11878 I V 2/27/1996 MCGAW INC STERILIZATION AND MICROBIOLOGY PROGRAM
FOR EXCEL PLASTIC IV CONTAINER
11879 A II 2/29/1996 MICROBIOPHARM JAPAN CO LTD DAUNORUBICIN HYDROCHLORIDE (CRUDE)
11880 I III 3/5/1996 TUBEX LTD IRELAND COLLAPSIBLE ALUMINIUM TUBES
11881 A III 3/5/1996 AMCOR FLEXIBLES BURGDORF GMBH COMPOUND PACKAGING MATERIAL
PAPER/OPA/ALUMINIUM/PAN-BAREX MATERIAL
#SOP 50963
11882 I II 3/13/1996 ORION CORP FERMION TERAZOSIN HYDROCHLORIDE DIHYDRATE
11883 I II 3/8/1996 EAGLE PICHER INDUSTRIES INC CEP-2563 DIHYDROCHLORIDE
11884 I IV 3/4/1996 MYLAN TECHNOLOGIES INC BERTEK CODE 44119 MEDILAM 3600
11885 I II 2/28/1996 UCB SA PHARMACEUTIQUE SECTEUR PIRACETAM
11886 I II 2/28/1996 UCB SA PHARMACEUTIQUE SECTEUR PIRACETAM TABLETS 80 MG AND 1200 MG
11887 I II 3/6/1996 IROTEC LABORATORIES SOTALOL HYDROCHLORIDE
11888 A II 3/8/1996 SIGMA ALDRICH IRELAND LTD PROMETHAZINE HYDROCHLORIDE
11889 I II 3/11/1996 OMICRON QUIMICA SA BISMUTH SUBSALICYLATE
11890 I II 2/22/1996 ISOCHEM SA FLUMECINOL
11891 I II 2/28/1996 MARUTI INDUSTRIAL CARBOHYDRATES SODIUM CARBOXYMETHYL CELLULOSE (CMC)
LTD
11892 I II 3/14/1996 PHARM ECO LABORATORIES INC AMPALEX TM, PRE-CLINICAL STUDIES , BY
CORTEX PHARMACEUTICALS, INC. IN IRVINE,
CALIFORNIA
11893 I II 3/18/1996 BORREGAARD AS BORREGAARD IOXILAN BULK DRUG SUBSTANCE
SYNTHESIS
11894 I II 3/15/1996 FINE CHEMICALS CORP ASTEMIZOLE
11895 I II 3/11/1996 FOREST LABORATORIES IRELAND LTD MANUFACTURING SITE,
FACILITIES,PERSONNEL, AND GENERAL
OPERATING PROCEDURES IN DUBLIN, IRELAND.
11965 I III 5/8/1996 CLARIANT CORP CLC-16645 25/1 LIGHT GREY COLOR
CONCENTRATE
11966 A II 2/21/1996 QUIMICA SINTETICA SA CIPROFLOXACIN HYDROCHLORIDE (NEW
SYNTHETIC PATHWAY)
11967 I IV 5/9/1996 WILLETT SYSTEMS LTD CIJ ETHANOL MICRO PILL CODING BLUE
PART201-0001-220,FG SF TOP-UP PART201-0001-
221,ET 3920E BLUE & TOP-UP PART201-0001-620
&201-0001-720 AND CIJ ET 3912F WASHDOWN
PART 201-0001-721
11968 A II 5/17/1996 ERREGIERRE SPA TICLOPIDINE HYDROCHLORIDE
11969 I II 5/14/1996 BACHEM FEINCHEMIKALIEN AG MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF BULK DRUG IN BUBENDORF,
SWITZERLAND.
11970 A II 5/15/1996 CEPHALON INC MODAFINIL DRUG SUBSTANCE
11971 I II 5/13/1996 GALENA AS CYCLOSPORINE
11972 I II 5/10/1996 ROCHE PRODUCTS LTD PYRIDOSTIGMINE BROMIDE TABLETS USP 30MG
Page 389
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
12011 I II 6/20/1996 MYLAN INC MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES OF TRIFLUOROTHYMIDINE IN
JOBAN, IWAKI-CITY, FUKUSHIMA PREFECTURE,
JAPAN.
### I II 6/24/1996 DEGUSSA AG WERK RADEBEUL CISPLATIN
### I III 6/25/1996 HYGENIC CORP TUBING GAR1030
### I V 6/24/1996 PPD WARS DIV PPD CRV INC METHODS WARS-P317.01 DETERMINATION OF
CLOZAPINE AND NORMETHYLCLOZAPINE IN
HUMAN PLASMA BY GAS LIQUID
CHROMATOGRAPHY
### A II 6/25/1996 PFANSTIEHL INC MALTOSE HIGH PURITY HYDRATE (LOW
ENDOTOXIN)
### A III 6/25/1996 BD MEDICAL - PHARMACEUTICAL PLASTIC PRE-FILLABLE STERILE SYRINGE
SYSTEMS SYSTEM
### I II 6/27/1996 ICN CZECH REPUBLIC AS L-EPHEDRINE HYDROCHLORIDE
### A II 6/28/1996 AVANTI POLAR LIPIDS INC TETRAMYRISTOYL CARDIOLIPIN (14:0 CA)
### I II 6/28/1996 ABBOTT LABORATORIES D-CHIRO-INOSITOL
### I II 6/25/1996 CHIREX LTD KETOPROFEN
### A II 6/27/1996 ESTEVE QUIMICA SA DICLOFENAC POTASSIUM
### I II 7/3/1996 GE SILICONES BAYSILONE FLUID M PH 300, 350, 500, 1000, 1500
### A II 6/25/1996 QUIMICA SINTETICA SA KETOCONAZOLE
### I V 7/1/1996 PPD WARS DIV PPD CRV INC DETERMINATION OF N-0923 IN HUMAN PLASMA
BY GC/MS (WARS-P333.00) AND BY LC/MS/MS
(WARS P380.00)
### I II 7/3/1996 WATSON LABORATORIES INC HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLETS, 10 MG\650 MG
### I II 7/2/1996 TAKEDA CHEMICAL INDUSTRIES LTD TAK-603
### I III 6/18/1996 DRYCOLOR AB MASTER BATCH PE 192214
### I II 7/8/1996 MICROBIOPHARM JAPAN CO LTD (1S,3R)-1,3-BIS(TERT-
BUTYLDIMETHYLSILYLOXY) ANDROST-5-EN-17-
ONE (SI-HDEA)
### I II 7/3/1996 WATSON LABORATORIES INC HYDROCODONE BITARTRATE TABLETS, 10 MG
### I II 7/2/1996 ASH STEVENS INC 2',3'-DIDEOXY-2'-B-FLUORO-ADENOSINE
### I III 7/11/1996 POLYFIL CORP AMC-0500-50 AND AMC-0500-95
### I II 7/5/1996 NORDMARK ARZNEIMITTEL GMBH PANCRELIPASE ENTERIC COATED
MICROTABLETS
### I II 7/30/1996 GROUPE LIPHA LIPHA LACASSAGNE; MANUFACTURING SITE,
FACILITIES, OPERATING PROCEDURES AND
PERSONNEL
### I II 6/25/1996 GENELABS DIAGNOSTICS PTE LTD MANUFACTURING SITE, FACILITIES, OPERATING
PROCEDURES, AND PERSONNEL IN SINGAPORE
Page 392
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 8/5/1996 CKS PACKAGING INC CLEAR AND WHITE PVC CYLINDER,
MANFACTURED IN MOORESVILLE, NORTH
CAROLINA
### I III 8/20/1996 CLARIANT CORP MASTERBATCHES DIVCLC-16645-A 25/1 LIGHT GREY COLOR
CONCENTRATE
### A II 8/23/1996 BASF GRENZACH GMBH TRICLOSAN
### A II 8/20/1996 JOHNSON MATTHEY PHARMACEUTICAL HYDROMORPHONE HCL
MATERIALS
### I II 8/26/1996 SHANDONG LUKANG PHARMACEUTICAL MANUFACTURING SITE, FACILITIES, OPERATING
CO LTD PROCEDURES AND PERSONNEL AT JINING CITY,
SHANDONG PROVINCE, CHINA
### A III 8/1/1996 MYLAN TECHNOLOGIES INC BERTEK CODE 44127 MEDIFLEX 1000
### I IV 8/19/1996 CARGILL FLAVOR SYSTEMS WATERMELON F-11420, MANFACTURED IN
LANGHORNE PENNSYLVANIA
### A IV 8/21/1996 EVONIK NUTRITION AND CARE GMBH PLASTOID B
### A II 8/28/1996 CURIUM US LLC SODIUM MOLYBDATE (99MO)
### A II 8/28/1996 AVANTI POLAR LIPIDS INC TRIOLEIN
### I II 8/28/1996 AVANTI POLAR LIPIDS INC 1, 2-DIOLEOYL-SN-GLYCERO-3-
PHOSPHOCHLINE (DOPC)
### I II 7/10/1996 LUKIAN PLASTIC CLOSURES LTD PLASTIC CAP MANUFACTURING SITE IN POINTE
CLAIRE, QUEBEC
### I II 8/29/1996 DIOSYNTH BV ATC/2 OXALATE
### A III 8/12/1996 LOPAREX LLC FILM BASED 8000B SERIES COATED RELEASE
LINERS
### A III 8/22/1996 LOPAREX LLC FILM BASED 4813 SERIES COATED RELEASE
LINERS
12110 I III 8/22/1996 LOPAREX INC GRADE 15835, 7 MIL NT HDP 92A/92A SILICONE
COATED RELEASE LINER
12111 I III 8/22/1996 LOPAREX INC GRADE 15827, 10 MIL NT PVC 92A/000 SILICONE
COATED RELEASE LINER
12112 I III 8/22/1996 LOPAREX INC GRADE 13361, 1.5 MIL CL PET 85A/86B SILICONE
COATED RELEASE LINER
12113 A III 8/22/1996 LOPAREX LLC GRADE 15719 S 6 NT HIP 800B/000
12114 I II 9/3/1996 SHOWA KAKO CORP FACILITIES, PERSONNEL AND GENERAL
OPERATING PROCEDURES
12115 I II 8/29/1996 SICOR SPA PORFIROMYCIN
12116 I II 9/3/1996 BI CHEMICALS INC ISOETHARINE HYDROCHLORIDE
12117 I II 8/27/1996 NAPP TECHNOLOGIES INC WARFARIN SODIUM CLATHRATE
12118 I IV 8/21/1996 MEYERS COLOUR COMPOUNDS LTD MMB-3479 GREY & MMB-7366 MAUVE
12119 I II 9/3/1996 TASMANIAN ALKALOIDS PARTY LTD BUTORPHANOL TARTRATE
### I II 9/5/1996 QUIMICA ESTEROIDAL SA DE CV ATRACURIUM BESYLATE
### I II 9/6/1996 EMMELLEN BIOTECH D-PSEUDOEPHEDRINE HYDROCHLORIDE
PHARMACEUTICALS LTD
### I II 9/3/1996 SHANDONG LUKANG PHARMACEUTICAL PENICILLIN G POTASSIUM BULK NON-STERILE
CO LTD INTERMEDIATE FOR FURTHER PROCESSING
Page 393
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 8/30/1996 BOREALIS AG BORMED RF825MO, BORMED RF830MO AND
BORMED RG835MO
### A II 9/4/1996 ROMARK BELGIUM BVBA NITAZOXANIDE
### I IV 8/30/1996 RESCO COLOURS INC BLUE CONCENTRATE (04VFV-415)
### I II 9/11/1996 FERRING PEPTIDE PRODUCTION AB FACILITIES, PERSONNEL, QUALITY ASSURANCE,
QUALITY CONTROL, MANFACTURING AND
GENERAL OPERATING PROCEDURES
Page 396
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 11/1/1996 SHANGHAI NUMBER 16 MANUFACTURING SITES, FACILITIES,
PHARMACEUTICAL FACTORY PERSONNEL AND OPERATING PROCEDURES IN
SHANGHAI, P.R. CHINA
### I II 11/8/1996 TEVA GROUP ACYCLOVIR USP
### I II 11/12/1996 PG AMIDE D-(-)-PHENYLGLYCINAMIDE (FG-AMIIDE)
12211 I II 11/11/1996 RECORDATI INDUSTRIA CHIMICA E IOPAMIDOL
FARMACEUTICA SPA
### I III 11/5/1996 CKS PACKAGING INC HIGH DENSITY POLYETHYLENE PLASTIC
CONTAINERS
### I III 11/6/1996 OY PREMIX LTD PRE-ELEC PP 1381
### A II 10/25/1996 CKD BIO CORP CYCLOSPORINE, NON-STERILE BULK, USP
### I III 10/28/1996 CODING PRODUCTS SV-59122, HOT STAMP INK IBBON
### A III 10/28/1996 CODING PRODUCTS SV-16848, HOT STAMP INK RIBBON
### I II 11/14/1996 FARCHEMIA SRL DICLOFENAC POTASSIUM
### I I 11/12/1996 NIPPON SODA CO LTD 4-NITROBENZYL (4R,5R,6S)-3-
DIPHENYLPHOSPHORYLOXY-6-[(R)-1-
HYDROXYETHYL]-4-METHYL-7-OXO-1-
AZABICYCLO[3.2.0.] HEPT-2-ENE-2-
CARBOXYLATE (CODE NAME MAP), A BULK
CHEMICAL DRUG SUBSTANCE INTERMEDIATE
Page 398
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/16/1996 TEVA PHARMACEUTICAL INDUSTRIES WARFARIN SODIUM CLATHRATE
LTD
### I II 11/22/1996 KYOWA HAKKO KOGYO CO LTD BUCILLAMINE BULK SUBSTANCE
### I II 12/16/1996 AKZO NOBEL CHEMICALS BV HALAMID PHARMA GRADE
### I II 12/6/1996 AVENTIS PHARMA DEUTSCHLAND GMBH BULK PROTIRELIN (THYROID RELEASING
HORMONE; TRH) DRUG SUBSTANCE
### A II 12/17/1996 CAMBREX PROFARMACO MILANO SRL SOTALOL HCL
### I II 12/13/1996 SANKYO CO LTD CS-834 DRUG SUBSTANCE
### I II 12/17/1996 JANSSEN PHARMACEUTICA NV LIAROZOLE FUMERATE DRUG SUBSTANCE
### I II 12/13/1996 SANKYO CO LTD CS-834 DRUG PRODUCT
### I II 12/16/1996 ROCHE DIAGNOSTICS GMBH 5-BROMO-2'-DEOXYURIDINE
### I I 12/13/1996 SHANGHAI NUMBER 1 MANUFACTURING SITE, FACILITIES,
PHARMACEUTICAL FACTORY PERSONNEL AND OPERATING PROCEDURES IN
SHANGHAI, CHINA
### I II 12/12/1996 UNION QUIMICO FARMACEUTICA SA PENTAACETYLIOPAMIDOL
### I II 12/12/1996 UNION QUIMICO FARMACEUTICA SA IOPAMIDOL STEP #1
(UQUIFA SA)
### I II 8/28/1996 SHANGHAI NUMBER 1 BIOCHEMICAL HEPARIN SODIUM
AND PHARMACEUTICAL CO
### I III 12/10/1996 CARCANO ANTONIO SPA ALUMINIUM FOIL, SMOOTH, SOFT TEMPER,
0.045 MM, LACQUERED FOR PRINTING ON ONE
SIDE AND LAMINATED WITH ADHESIVE TO
POLYETHYLENE FILM 0.020 MM ON THE OTHER
SIDE
### I II 12/20/1996 NANOSYSTEMS MK-639 NANOCRYSTAL
### I II 12/19/1996 BIODOME MANUFACTURING SITES, FACILITIES, AND
PERSONNEL IN CEDEX, FRANCE
### I I 12/23/1996 BAYER DE MEXICO SA DE CV MANUFACTURING SITES, FACILITIES,
OPERATING PROCEDURES, AND PERSONNEL IN
DELEGACION MIGUEL HIDALGO, MEXICO
### I II 12/19/1996 EXCELLA GMBH FLUNIXIN MEGLUMINE
### I II 12/20/1996 SA AJINOMOTO OMNICHEM NV BALSALAZIDE DISODIUM
### I II 12/23/1996 BACHEM CALIFORNIA IB-367
### I II 12/18/1996 COURTAULDS CHEMICALS BALSALAZIDE DISODIUM
### I V 12/19/1996 BIODOME BIOSET INFUSION, IN CEDEX, FRANCE
### A II 12/18/1996 QUIMICA SINTETICA SA FLUOXETINE HYDROCHLORIDE
### I II 12/23/1996 INDUSTRIALE CHIMICA SRL FLUOXETINE HYDROCHLORIDE
### A II 12/24/1996 ASPEN OSS BV ETONOGESTREL
### A II 12/27/1996 SERIPHARM SAS PACLITAXEL
### A II 12/30/1996 VIFOR INTERNATIONAL INC DEXFER HUMAN USA (IRON DEXTRAN POWDER)
Page 399
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 12/20/1996 ITACEL FARMOQUIMICA LTDA TABULOSE SC, MICROCRYSTALLINE
CELLULOSE AND CARBOXYMETHYLCELLULOSE
SODIUM
### I III 12/24/1996 ALVEO AG ALVEOLIT TEE 0500 WHITE
### I III 12/31/1996 BAG PACK INC BOTTOM SEAL POLY BAGS
### I V 1/2/1997 DRUG DEVELOPMENT OFFICE CANCER BACKGROUND, PERSONNEL AND PROCEDURES
RESEARCH CAMPAIGN FOR DEVELOPMENT OF NEW ANTI-CANCER
AGENTS IN UNITED KINGDOM
### I II 12/16/1996 RHONE POULENC INC IGEPAL CA 630 SPECIAL (OCTOXYNOL-9)
### I II 1/3/1997 SIGMA CHEMICAL CO PHLORIDZIN FROM APPLE SIGMA PRODUCT NO.
P0289
### I IV 12/27/1996 BOC GROUP INC THE BOC GASES EXCIPIENT, LIQUEFIED NITROGEN
### I III 8/31/1996 IRIS LTD DIV ARCO BEAUTY LTD SURGICAL COIL 100% COTTON AND 100%
RAYON-PHARMACEUTICAL GRADE
### I I 1/6/1997 TAKASAGO INTL CORP MANUFACTURING SITES, FACILITIES,
PERSONNEL, AND GENERAL OPERATING
PROCEDURES AT FINE CHEM CO., LTD. IN
OGASA-GUN, JAPAN FOR (R)-4-
MERCAPTOPYRROLIDIN-2-ONE, OR (R)
### I II 1/10/1997 CHANGZOU SYNTHETIC MATERIAL ALBENDAZOLE
PLANT
### A II 1/9/1997 CORDEN PHARMA CHENOVE OXYBUTYNIN HYDROCHLORIDE
### I II 1/6/1997 TAKASAGO INTL CORP (R)-4-MERCAPTOPYRROLIDIN-2-ONE, OR (R)-
MPD
12311 I III 12/16/1996 BASELL POLIOLEFINE ITALIA SPA LUPOLEN 2426 F
### I III 12/16/1996 BASF AKTIENGESELLSCHAFT LUPOLEN 1804 H
### I II 1/13/1997 ANTIBIOTIC CO STERILE SULBACTAM SODIUM
### I III 12/11/1996 SOLVIN SA IXAN PVDC WA 36
### I III 12/11/1996 SOLVAY SA IXAN PVDC PA 120
### I III 12/11/1996 SOLVIN SA IXAN PVDC WA 63
### I III 11/21/1996 SOLVAY SA IXAN PVDC PA 344
### I III 12/10/1996 SOLVIN SA IXAN PVDC PA 331
### I III 12/10/1996 SOLVIN SA IXAN PVDC WA 50
### I II 12/30/1996 DOTTIKON EXCLUSIVE SYNTHESIS AG 6.7-DIHYDRO-3-ETHYL-2-METHYLINDOL-4-ONE
(EMOTI)
### A III 1/16/1997 COVESTRO DEUTSCHLAND AG MAKROLON 2458-FBL
### I IV 1/7/1997 DOW CORNING CORP DOW CORNING BIO-PSA AMINE-COMPATIBLE
HOT MELT SILICONE PRESSURE SENSITIVE
ADHESIVES
### A III 12/4/1996 NAN YA PLASTICS CORP AMERICA TAIRLIN COPOLYMER PET
SOUTH CAROLINA PLANT
### I III 1/17/1997 BASF AKTIENGESELLSCHAFT BASONAT F DS 3425
### I III 1/15/1997 TUBCOR SA COLLAPSIBLE ALUMINIUM TUBE
### I II 1/14/1997 UNION QUIMICO FARMACEUTICA SA AG 1346
Page 400
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 1/21/1997 CATALENT PHARMA SOLUTIONS LLC TESSALON 100 MG AND 200 MG SOFTGEL
CAPSULES AND BENZONATATE 100 MG AND 200
MG SOFTGEL CAPSULES
### A II 1/20/1997 IDT AUSTRALIA LTD MITOXANTRONE HYDROCHLORIDE USP
### A IV 1/16/1997 DUPONT NUTRITION USA INC AVICEL RC/CL MICROCRYSTALLINE CELLULOSE
AND CARBOXYMETHLCELLULOSE SODIUM
### I III 1/6/1997 PRECISE PRODUCTS AND BOTTLE PLUG AND DIP TUBE ASSEMBLY DWG
DEVELOPMENT CORPORATION NO. P9601-05 REV. A.
### I II 1/23/1997 GANES CHEMICALS INC PENNSVILLE R-NORSELEGILINE BASE AND HYDROCHLORIDE
DIV
### I II 1/23/1997 NV ORGANON NORGESTOMET
### I III 1/23/1997 TAYLOR WHARTON SEAMLESS STEEL COMPRESSED GAS
CYLINDERS
### I II 1/24/1997 PT SINKONA INDONESIA LESTARI QUINIDINE GLUCONATE
### I III 1/27/1997 WEST CO INC MERCURY BOTTLE ASSEMBLY
### I III 1/27/1997 TETRAFLUOR INC TEFLON O-RING GASKET FOR COMPRESSED
GAS CYLINDER
### A III 1/23/1997 LUXFER GAS CYLINDERS HIGH PRESSURE ALUMINUM COMPRESSED GAS
CYLINDERS
### I IV 1/23/1997 ARYLESSENCE INC ARYLESSENCE 00798 N AND A CHERRY FLAVOR,
MANFACTURED IN MARIETTA, GA
### I III 1/7/1997 GEORGIA GULF CHEMICALS AND PVC COMPOUND, 8272 WHITE 344
VINYLS LLC
### I II 1/24/1997 CORDEN PHARMA BERGAMO SPA OXAPROZIN
### A II 1/28/1997 DR REDDYS LABORATORIES LTD NAPROXEN
### A II 1/28/1997 DR REDDYS LABORATORIES LTD NAPROXEN SODIUM
### A V 1/2/1997 APTAR STELMI SAS ULTRACLEAN-6 WASHING PROCESS
### I V 1/27/1997 NATIONAL INSTITUTES HEALTH PRECLINICAL TOXICOLOGY DATA FOR THE
NATIONAL CANCER INSTITUTE AGENT ECTEINASCIDIN 743 IN BETHESDA, MD
### I III 1/8/1997 CREST FLEXIBLE PACKAGING LTD PACKAGING MATERIALS AND MEDICAL
PACKAGING (POLYESTER/ADHESIVE/ALUMINIUM
FOIL/ADHESIVE/POLYETHYLENE)
### A II 1/29/1997 ZACH SYSTEM SA VENLAFAXINE HYDROCHLORIDE
### I III 1/16/1997 3M DRUG DELIVERY SYSTEMS METHOD MS23 REVISION 1 GC/MS ANALYSIS OF
ENALAPRIL AND ENALAPRILAT IN HUMAN
PLASMA
### A II 1/31/1997 ANTIBIOTICOS SA 6-AMINO PENICILLANIC ACID
### I II 2/5/1997 TASMANIAN ALKALOIDS PARTY LTD NALTREXONE BENZOATE
### I II 2/3/1997 EGIS PHARMACEUTICALS PRIVATE LTD BUSPIRONE HYDROCHLORIDE USP BULK
### I II 2/2/1997 ROLABO SL MANUFACTURING SITES, FACILITIES,
PERSONNEL AND GENERAL OPERATING
PROCEDURES IN ZARAGOZA, SPAIN
### I II 2/6/1997 PHARMACEUTICAL FINE CHEMICALS RIFAXIMIN
PFC BAHAMAS LTD
Page 401
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 2/4/1997 VIS FARMACEUTICI INSTITUTO FLUVOXAMINE MALEATE
SCIENTIFICO VINEZIE SPA
### I II 2/3/1997 VIS FARMACEUTICI INSTITUTO ETIDRONATE DISODIUM
SCIENTIFICO VINEZIE SPA
### A II 1/31/1997 DOW FRANCE AMBERLITE IRP69
### A II 2/4/1997 DIVIS LABORATORIES LTD DEXTROMETHORPHAN HYDROBROMIDE USP
### I II 2/11/1997 VICKSBURG CHEMICAL CO POTASSIUM NITRATE USP GRADE
### A III 1/30/1997 SHERWOOD VALVE LLC COMPRESSED CYLINDER GAS VALVES, SERIES
6074X
### I III 2/11/1997 AMPACET CORP 160325 BLUE UV POLYETHYLENE
MASTERBATCH
### I II 1/31/1997 EURAND AMERICA INC DIPHENHYDRAMINE CITRATE (MICROCAPS)
### I II 1/31/1997 EURAND AMERICA INC MICROCAPS CIMETIDINE, USP
### A III 2/10/1997 INOVYN EUROPE LTD INOVYN TM PVC 257RF
### I II 2/10/1997 INDUSTRIALE CHIMICA SRL MANUFACTURING SITE, FACILITIES,
PERSONNEL AND GENERAL OPERATING
PROCEDURES IN SARONNO, ITALY
### I II 2/13/1997 OMAN CHEMICALS AND 6-AMINO PENICILLANIC ACID
PHARMACEUTICALS LLC
### I III 2/11/1997 FLEX INDUSTRIES LTD POLYESTER FILM (BIAXIALLY ORIENTED)
### I II 2/5/1997 MATERIALS PROCESSING TECHNOLOGY DIRECTLY COMPRESSIBLE ACETAMINOPHEN
INC DC-90B
### I II 2/5/1997 MATERIALS PROCESSING TECHNOLOGY DIRECTLY COMPRESSIBLE ACETAMINOPHEN
INC DC-90A
### A II 2/18/1997 GEDEON RICHTER PLC DESOGESTREL
### I II 2/21/1997 DEGUSSA AG WERK RADEBEUL CARBOPLATIN, USP
### I III 2/18/1997 CLARIANT CORP GLC-18713 25/1 TURQUOISE COLOR
CONCENTRATE
### I II 2/24/1997 NOVOCOL PHARMACEUTICAL CANADA AUTOINJECTOR PRODUCTION
INC
### A IV 2/11/1997 MANTROSE HAEUSER CO INC CERTISEAL FC-300A
### I II 2/24/1997 USV LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
MAHARASHTRA, INDIA
### A II 2/24/1997 USV PRIVATE LTD GLIPIZIDE USP
### I III 2/18/1997 BASF CORP GLEITMITTELDISPERSION 8645
### I III 2/12/1997 DANAPAK FLEXIBLES PHARMACEUTICAL COMPONENT
### I V 2/24/1997 NATIONAL INSTITUTES HEALTH DAIDS POLICIES AND PROCEDURES
NATIONAL INSTITUTE ALLERGY AND PERTAINING TO CLINICAL TRIALS CONDUCTED
INFECTIOUS DISEASES UNDER DAIDS-SPONSORED INDS
### I III 3/3/1997 4P VERPACKUNGEN RONSBERG GMBH FLEXIBLE LAMINATE FOR TUBE PRODUCTION
### A II 2/19/1997 AJINOMOTO CO INC LEVODOPA
### I II 2/24/1997 ASTELLAS PHARMA INC FORMOTEROL FUMARATE
Page 402
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 2/24/1997 H LUNDBECK AS MANUFACTURING SITE, FACILITIES,
PERSONNEL AND GENERAL OPERATING
PROCEDURES IN VALBY, DENMARK
### I II 2/24/1997 H LUNDBECK AS MANUFACTURING SITE, FACILITIES,
PERSONNEL AND GENERAL OPERATING
PROCEDURES IN SEAL SANDS, UNITED
KINGDOM
### I II 2/24/1997 H LUNDBECK AS MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
LAMSAS, DENMARK
### A II 2/24/1997 H LUNDBECK AS CITALOPRAM HYDROBROMIDE
### A II 2/21/1997 SIEGFRIED PHARMACHEMIKALIEN SELEGILINE
MINDEN GMBH
### I II 2/27/1997 SOLVAY DUPHAR BV CALCIFEDIOL
### I II 2/21/1997 IWAKI SEIYAKU CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES AT
THE SHIZUOKA FACTORY IN SHIZUOKA, JAPAN
Page 403
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 3/5/1997 DUPONT NUTRITION USA INC AQUACOAT CPD CELLULOSE ACETATE
PHTHALATE AQUEOUS DISPERSION
### I III 2/26/1997 INTERNATIONAL GROUP INC IGI 1239
### I III 3/6/1997 AMPACET CORP 100488 AB POLYETHYLENE MASTERBATCH
### I III 3/6/1997 AMPACET CORP 10437 SLIP POLYETHYLENE MASTERBATCH
### I V 2/28/1997 CIBA VISION STERILE MANUFACTURING STERILE
12411 I II 3/10/1997 BACHEM CALIFORNIA PEPTIDE P280
### A II 3/10/1997 INDIVIOR UK LTD BUPRENORPHINE HCI
### I III 2/7/1997 VALSPAR CORP PHENOLIC SPRAY COATING
### I III 2/7/1997 VALSPAR CORP PHENOLIC SPRAY COATING
### I III 1/31/1997 BASF AKTIENGESELLSCHAFT NOVOLEN 3248 TC
### I II 3/14/1997 JANSSEN PHARMACEUTICA NV LOVIRIDE DRUG SUBSTANCE
### A II 3/14/1997 TEVA PHARMACEUTICAL INDUSTRIES CALCITRIOL USP
LTD
### I II 3/1/1997 OTSUKA PHARMACEUTICAL CO LTD NADIFLOXACIN DRUG SUBSTANCE
### A II 3/17/1997 AMRI RENSSELAER INC SULFAMYLON (MAFENIDE) ACETATE
### I II 3/18/1997 KYOWA HAKKO KOGYO CO LTD KW-2189 DRUG SUBSTANCE
### I II 3/14/1997 NOVARTIS PHARMACEUTICALS CORP TESSALON DRUG SUBSTANCE, (BENZONATATE,
USP)
### A V 3/7/1997 STERIGENICS US LLC STERILIZATION FACILITY
### I II 2/15/1997 CKD BIO CORP 7-AMINOCEPHALOSPORANIC ACID, (7-ACA)
### I II 3/17/1997 BIOINDUSTRIA TERAZOSIN HCI. 2H20 BULK SUBSTANCE
### I II 3/20/1997 PROMETIC BIOSCIENCES LTD MIMETIC ORANGE 1-6XL
### I II 3/19/1997 YAMANOUCHI IRELAND CO LTD FORMOTEROL FUMERATE
### I II 3/19/1997 YMC CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
ISHIKAWA, JAPAN
### I III 2/11/1997 ASPELL POLYMERES LACQTENE 2003 SN 53 U
### I III 3/27/1997 DSM PERFORMANCE POLYMERS STAMYLAN P 17M10
### I III 3/27/1997 DSM POLYETHYLENES STAMYLAN HD 7625
### I III 3/12/1997 ALBIS PLASTIC GMBH LUPOLEN 1810 S WHITE 99950
### I III 3/12/1997 ALBIS PLASTIC GMBH LUPOLEN 1810 E WHITE 99950
### I III 3/12/1997 ALBIS PLASTIC GMBH LUPOLEN 3020 D WHITE 99950
### I III 3/12/1997 ALBIS PLASTIC GMBH LUPOLEN 5021 D WHITE 99950
### I III 3/12/1997 ALBIS PLASTIC GMBH LUPOLEN 5031 L WHITE 99950
### I III 3/12/1997 ALBIS PLASTIC GMBH LUPOLEN CONZENTRATE SL 02 OA
### I II 3/26/1997 SIEGFRIED LTD FLUOXETINE HYDROCHLORIDE
### I II 3/12/1997 PFC ITALIANA SRL DIV ALFA CHEMICALS BACLOFEN
ITALIANA
### I II 3/6/1997 SANOFI AVENTIS CHIMIE CLOPIDOGREL BISULFATE
### I II 3/24/1997 CORDEN BIOCHEM GMBH 7-AMINOCEPHALOSPORANIC ACID, ENZYMATIC
### A II 3/31/1997 SPECGX LLC DIPHENOXYLATE HYDROCHLORIDE USP
### I II 3/31/1997 ABBOTT LABORATORIES CHEMICAL AND IOPAMIDOL, USP
AGRICULTURAL PRODUCTS DIV
### I II 3/28/1997 SCHERING PLOUGH PRODUCTS INC STERILE WATER FOR INJECTION
Page 404
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 3/26/1997 FERMION OY ENTACAPONE
### I II 3/18/1997 NAPP TECHNOLOGIES INC NABUMETONE
### I III 3/21/1997 CREST FLEXIBLE PACKAGING LTD PAPER/PE/FOIL/PE
### I II 3/24/1997 BEA FILTRI SPA MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
MILANO, ITALY
### I III 4/2/1997 AMPACET CORP 100652 ANTIBLOCK SLIP POLYETHYLENE
MASTERBATCH
### I II 4/3/1997 PHARM ECO LABORATORIES INC 2-AMINO-5-PHENYL-4(5H)-OXAZOLONE-
(PEMOLINE)
### A III 4/1/1997 CODING PRODUCTS SV-54258
### A III 4/1/1997 CODING PRODUCTS SV-14258
### I III 4/1/1997 CODING PRODUCTS SV-14157NNT
### I III 4/4/1997 SAFTA SPA STERIFOIL 121235
### I II 4/2/1997 SCHENK FILTERBAU GMBH MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
WALDSTETTEN, GERMANY
### I II 4/7/1997 GUFIC BIOSCIENCES LTD MICONAZOLE NITRATE USP
### I III 4/2/1997 AMPACET CORP 109982 ANTIBLOCK POLYETHYENE
MASTERBATCH
### I III 3/13/1997 BASF AKTIENGESELLSCHAFT NOVOLEN 110 H Q651
### I III 4/8/1997 LOPAREX BV FL2000 175UM HDPE EASY/EASY (PRODUCT
CODE 78D171)
### A III 4/4/1997 FUJIMORI KOGYO CO LTD PLASTIC FILM AND BAG
### I II 4/8/1997 SANOFI SYNTHELABO INC CLOPIDOGREL BISULFATE
### I II 4/9/1997 DAIICHI PHARMACEUTICAL CO LTD DX-8951F DRUG SUBSTANCE
### I II 3/6/1997 SAMYANG GENEX RESEARCH CORP BULK PHARMACEUTICAL CHEMICAL GENEXOL,
PLANT A
### I II 4/9/1997 ADVANCED CHEMTECH INC GONADERELIN ACETATE BULK
PHARMACEUTICAL CHEMICAL
### A III 4/10/1997 3M DRUG DELIVERY SYSTEMS PACKAGING MATERIAL FOR THE CICLESONIDE
HFA METERED DOSE INHALER
### A III 4/17/1997 WIPF AG POLYESTER-ALUMINIUM-POLYACRYLONITRILE
LAMINATE
### I III 4/11/1997 LUBRIZOL ADVANCED MATERIALS INC STAT-RITE E-1150
### I II 4/15/1997 DR REDDYS LABORATORIES LTD DEXTROMETHORPHAN HYDROBROMIDE
### I III 3/25/1997 DRYCOLOR AB MASTERBATCH PE 192301
### A II 4/14/1997 UNIQUE CHEMICALS DICLOFENAC SODIUM USP
### A III 4/11/1997 CLARIANT MASTERBATCHES NORDEN MASTERBATCH PE 192183
AB
### A II 4/14/1997 ESTEVE QUIMICA SA QUINAPRIL HCL
### A II 4/11/1997 EXCELLA GMBH AND CO KG METHOTREXATE SODIUM
Page 405
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I I 4/14/1997 DOCTORS ORGANIC CHEMICALS LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
K. ILLINDALAPARRU, TANUKU, ANDHRA
PRADESH, INDIA
### I IV 4/10/1997 ADHESIVES RESEARCH INC MEDICAL GRADE ADHESIVES
### A II 4/17/1997 RANKE QUIMICA SA ALMOTRIPTAN, LAS 31416 D,L HYDROGEN
MALATE
### I II 4/18/1997 PROQUINA SA ESTRIOL
### I II 4/22/1997 CARA PARTNERS WALLINGSTOWN LTD GINKGO BILOBA EXTRACT
### A III 4/18/1997 SCHOTT FRANCE PHARMA SYSTEM SAS GLASS AMPOULES
### I III 4/15/1997 CLARIANT CORP BLC-19380 25/1 PROCESS BLUE COLOR
CONCENTRATE
### I II 3/4/1997 POLFA TARCHOMIN 7-ADC ACID
### I II 4/25/1997 SYNGEN BIOTECH CO LTD LOVASTATIN
### I IV 4/10/1997 CERESTAR USA INC HYDROXYPROPYL BETA CYCLODEXTRIN
### I IV 4/24/1997 LA DREYFUS CO DREYCO CHEWING GUM BASE
### I II 4/21/1997 SCHERING GMBH UND CO MANUFACTURING SITE, FACILITIES,
PRODUKTIONS KG PERSONNEL AND PROCEDURES IN WEIMAR,
GERMANY
### A II 4/8/1997 DYNAMIT NOBEL GMBH GLYCEROLTRINITRATE-DUROTAK 387-2516
EXPLOSIVSTOFF UND SYSTEMTECHNIK SOLUTION
### A V 4/24/1997 STERIGENICS US LLC CONTRACT STERILIZATION FACILITY IN
HAYWARD, CA
### I III 2/24/1997 ALVEO AG ALVEOLIT TEE 3000 WHITE
### I III 2/24/1997 ALVEO AG ALVEOLIT TEE 1000 WHITE
### I II 4/30/1997 REHEIS INC ALUMINUM NITRATO HYDRATE
### I II 3/27/1997 HARBIN PHARMACEUTICAL FACTORY PENICILLIN G POTASSIUM CRUDE
### I II 4/28/1997 NANOSYSTEMS RAPAMYCIN NANOCRYSTAL COLLOIDAL
DISPERSION-JAR MILLING PROCESS
### I II 4/21/1997 THATCHER CO CHLORHEXIDINE GLUCONATE, 20% (W/V)
### A III 3/27/1997 LANXESS CORP PERBUNAN
### I IV 4/30/1997 ROUGIER INC CONTRAMID
### I III 4/30/1997 BECTON DICKINSON AND CO BD AUTO-INJECTOR CARTRIDGE
### I II 5/8/1997 CHONGQING DAXIN PHARMACEUTICAL LOVASTATIN, USP
CO LTD
### A III 5/5/1997 BD MEDICAL - PHARMACEUTICAL BD READYFILL™
SYSTEMS
### I II 4/28/1997 PLASTIAPE SPA MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
OSNAGO, ITLAY
### A III 4/28/1997 PLASTIAPE SPA AEROLISER INHALATION DEVICE
### I IV 5/8/1997 HENKEL CORP GLUCOPON 625 UP
### I II 5/8/1997 VERA LABORATORIES LTD RANITIDINE BULK DRUG
Page 406
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I I 5/8/1997 VERA LABS LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
ANDHRA PRADESH, INDIA
### I II 5/13/1997 NEULAND LABORATORIES LTD RANITIDINE
### I III 5/8/1997 AMPACET CORP 10562 PROCESS AID POLYETHYLENE
MASTERBATCH
### I II 5/15/1997 EGIS PHARMACEUTICALS PRIVATE LTD LEVODOPA USP BULK
### A III 4/24/1997 A SCHULMAN INC POLYETHYLENE PACKAGING COMPONENTS
### I III 5/5/1997 BASF AKTIENGESELLSCHAFT NOVOLEN 1100 H
### I V 5/16/1997 RENTSCHLER BIOTECHNOLOGIE GMBH STERILE PROCESSING FACILITY LOCATED IN
AND CO LAUPHEIM, GERMANY
### A II 5/15/1997 LUSOCHIMICA SPA CARTEOLOL HYDROCHLORIDE
### I III 5/15/1997 ROLLPRINT PACKAGING PRODUCTS INC RPP #26-3027
### I III 5/20/1997 PECHINEY SOPLARIL FLEXIBLE EUROPE LID 20 UM ANNEALED FOIL
### I III 5/20/1997 PECHINEY SOPLARIL FLEXIBLE EUROPE LID 25 UM ANNEALED FOIL
### I III 5/20/1997 PECHINEY SOPLARIL FLEXIBLE EUROPE LID 25 UM HARD FOIL
### I III 5/20/1997 PECHINEY SOPLARIL FLEXIBLE EUROPE LID 30 UM ANNEALED FOIL
### I III 5/20/1997 PECHINEY SOPLARIL FLEXIBLE EUROPE LID 30 UM HARD FOIL
### I III 5/20/1997 PECHINEY SOPLARIL FLEXIBLE EUROPE LID 15 UM HARD FOIL
### I III 6/25/1997 PECHINEY SOPLARIL FLEXIBLE EUROPE LID 15 UM HARD FOIL WITHOUT PHTALATES
### I III 6/25/1997 PECHINEY SOPLARIL FLEXIBLE EUROPE LID 20 UM HARD FOIL WITHOUT PHTALATES
### I III 6/25/1997 PECHINEY SOPLARIL FLEXIBLE EUROPE LID 20 UM HARD FOIL WITHOUT PHTALATES
### I III 6/25/1997 PECHINEY SOPLARIL FLEXIBLE EUROPE LID 20 UM ANNEALED FOIL WITHOUT
PHTALATES
### I III 6/25/1997 PECHINEY EMBALLAGE ALIMENTAIRE LID 25 UM ANNEALED FOIL WITHOUT
PHTALATES
### I III 6/25/1997 PECHINEY SOPLARIL FLEXIBLE EUROPE LID 30 UM ANNEALED FOIL WITHOUT
PHTALATES
### I II 7/8/1997 PFC ITALIANA SRL DIV ALFA CHEMICALS TERAZOSIN HCL-FORM 1
ITALIANA
### I IV 7/7/1997 SYMRISE INC PINEAPPLE FLAVOR 9/H04395, CHOCOLATE
FLAVOR SPRAY DRIED 9/H07215, STRAWBERRY
FLAVOR ARTIFICIAL 9/H04832, AND VANILLA
FLAVOR 9/H00625
### I II 6/17/1997 THERATECH INC ALORA ESTRADIOL TRANSDERMAL SYSTEM
Page 409
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 7/11/1997 NICOBRAND LTD NICOTINE BITARTRATE DIHYDRATE
### A II 7/9/1997 ACS DOBFAR SPA SODIUM BICARBONATE, STERILE
### A II 7/9/1997 ACS DOBFAR SPA CEPHALOTHIN SODIUM, ORAL GRADE
### I III 7/7/1997 GRAND POLYMER CO LTD GRANDPOLYPRO J216
### A III 7/7/1997 SGD SA SILICONIZATION PROCEDURE
### I II 7/11/1997 FERMION OY AZATHIOPRINE
### I IV 7/8/1997 MITSUBISHI CHEMICAL CORP SUCROSE STEARIC ACID ESTERS AND
SUCROSE PALMITIC ACID ESTERS
### I V 7/11/1997 NATIONAL INSTITUTES HEALTH PRECLINICAL PHARMACOLOGY AND
NATIONAL CANCER INSTITUTE TOXICOLOGY AGENT ISIS 5320 (NSC 665353), IN
BETHESDA, MARYLAND
### A III 7/22/1997 CONSTANTIA SAN PROSPERO SRL PVC FOIL DRUG PACKAGING MATERIAL
LAMINATED TO PE FILM
### I III 7/15/1997 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMULATION B5310-45 N
GRAY
### I II 7/18/1997 TORRENT GUJARAT BIOTECH LTD 6-AMINO PENICILLANIC ACID
### I II 7/18/1997 TORRENT GUJARAT BIOTECH LTD PENICILLANIC G POTASSIUM
### I II 7/18/1997 CARBOGEN AMCIS AG TROPICAMIDE
### I III 7/11/1997 SKILLPACK PET TECHNOLOGIES BV POLYETHYLENE TEREPHTHALATE PACKAGING
MATERIALS
### I II 7/23/1997 NORDEN PACK INTERNATIONAL AB MANUFACTURING SITE, FACILITIES,
PERSONNEL, AND OPERATING PROCEDURES IN
HELSINGBORG AND ASTORP, SWEDEN
### I II 7/18/1997 LONZO LTD IMEOL
### A II 7/17/1997 BASF SE UVINUL N 539 T
### I III 7/9/1997 DUDEK PLAST AS TABLET CONTAINER AND CAPS IN FIVE SIZES
150ML, 250ML, 300ML, 400ML AND 500ML
### A III 7/9/1997 LINHARDT GMBH AND CO KG ALUMINIUM TUBES
### A III 7/24/1997 BRASKEM AMERICA INC POLYPROPYLENE 5E88S
### I II 7/24/1997 NANOSYSTEMS L-754,030 NANOCRYSTAL COLLOIDAL
DISPERSION-JAR MILLING PROCESS,
MANFACTURED IN HORSHAM, PA
### A II 7/23/1997 QUIMICA SINTETICA SA OMEPRAZOLE
### I III 7/21/1997 SUD CHEMIE PERFORMANCE AIRSEC DRI-PAX POLY TUBES, DESICCANT
PACKAGING PLUGS, AND DESICCANT STOPPERS
### A II 7/25/1997 TEVA PHARMACEUTICAL INDUSTRIES DIFLORASONE DIACETATE BULK DRUG
LTD
### I III 7/28/1997 ERACO AS CHILD RESISTANCE AND TAMPER EVIDENCE
CLOSURES
### I II 7/24/1997 NEMO SA MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
BARCELONA, SPAIN
### I III 7/30/1997 3M DRUG DELIVERY SYSTEMS DIV METERED DOSE AEROSOL VALVE
12611 A IV 6/18/1997 SHANGHAI GUANG DE LI CAPSULE CO GELATIN CAPSULES
LTD
Page 410
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 8/5/1997 PFANSTIEHL INC AMMONIUM LACTATE
### A II 8/4/1997 ERREGIERRE SPA TIOCONAZOLE, .
### I II 8/5/1997 DIOSYNTH BV DEHYDROISOANDROSTERONE SODIUM
SULPHATE
### I II 7/29/1997 ESTEVE QUIMICA SA VPA-985
### I II 6/9/1997 GEDEON RICHTER LTD GLUTETHIMIDE
### I IV 8/6/1997 EASTMAN DENTAL CENTER SAIB SPECIAL GRADE (SG)
### I II 8/8/1997 RANBAXY PHARMACEUTICALS INC ETODOLAC DRUG SUBSTANCE
### I II 8/5/1997 ORGANICHEM CORP MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURE IN
CORK, IRELAND.
### A II 8/11/1997 BACHEM AMERICAS INC VASOA INTESTINAL PEPTIDE (VIP), HUMAN
### I II 8/12/1997 MALLINCKRODT CHEMICAL INC ACYCLOVIR USP (MICRONIZED), CODED 2524
### I II 8/14/1997 FINORGA SAS 6-BENZYL-1-ETHOXYMETHYL-5-
ISOPROPYLURACIL
### I II 8/14/1997 PHARMACEUTICAL FINE CHEMICALS NABUMETONE
PFC BAHAMAS LTD
### A III 3/27/1997 NOLATO JAYCARE LTD SECURIPAC, VITAPAC CONTAINER WITH JAYCAP
CLOSURE
### I III 8/14/1997 AMPACET CORP 11200 WHITE MASTERBATCH
### I II 8/21/1997 HANA BIOSCIENCES INC VINCRISTINE SULFATE LIPOSOME INJECTION
### A IV 8/21/1997 DUPONT NUTRITION USA INC AVICEL CE-15 MICROCRYSTALLINE CELLULOSE
AND GUAR GUM
### I II 8/22/1997 PHARMA BIOTECHNOLOGIE HANNOVER MANUFACTURING SITE, FACILITIES,
GMBH PERSONNEL, AND OPERATING PROCEDURES IN
SIGNES, FRANCE.
### I II 8/15/1997 VEGEFLORA EXTRACOES DO PILOCARPINE USP
NORDESTE LTDA
### I II 8/25/1997 HUBEI PHARMACEUTICAL FACTORY NAPROXEN USP
### I II 8/27/1997 UNION QUIMICO FARMACEUTICA SA FLUOXETINE HYDROCHLORIDE, USP
### I II 8/27/1997 HAMNMI FINE CHEMICAL CO LTD CEFOTAXIME ACID
### I III 8/26/1997 STEDIM SA EVA BAGS
### A II 8/27/1997 EXCELLA GMBH AND CO KG DOXAZOSIN MESYLATE
### I II 8/29/1997 ABBOTT LABORATORIES TROMETHAMINE,USP
### I II 8/29/1997 SUMITOMO CHEMICAL CO LTD BMCB(INERMEDIATE)
### A II 8/28/1997 FLUOROMED LP APF-N40M
### I II 8/29/1997 ABBOTT LABORATORIES CHEMICAL AND BETAXOLOL HYDROCHLORIDE, USP
AGRICULTURAL PRODUCTS DIV
### I II 9/2/1997 NATURAL BIOLOGICS LLC NATURAL CONJUGATED ESTROGEN-BULK
INGREDIENT
### A IV 9/3/1997 ACG ASSOCIATED CAPSULES PVT LTD EXCIPIENT HARD GELATIN CAPSULES SHELLS
### I II 8/21/1997 PAPIERFABRIK DIV SCHOELLER AND GEFOLUX BOPP/ML
HOESCH GMBH
Page 411
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I V 8/18/1997 NATIONAL INSTITUTES HEALTH OVERSIGHT, REVIEW, MONITORING AND
NATIONAL CANCER INSTITUTE DIV AUDITING PROCEDURES OF NCI, DCPD IN
CANCER PREVENTION AND CONTROL BETHESDA, MD.
### A II 9/4/1997 EUTICALS SPA TICLOPIDINE HYDROCHLORIDE
### I II 9/8/1997 SUMITOMO SEIKA CHEMICALS CO LTD MANUFACTURING SITE , FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
HYOGO, JAPAN.
### A II 9/8/1997 SUMITOMO SEIKA CHEMICALS CO LTD 2,4-THIAZOLE WING ACID HOSU A ESTER
### I II 9/5/1997 MALLINCKRODT CHEMICAL INC PRAMLINTIDE STD AMYLIN
### A II 9/8/1997 USV PRIVATE LTD METFORMIN HCL USP
### I III 7/10/1997 APTAR FRANCE SAS VP3 PUMPS
### I II 9/8/1997 CILAG AG TERAZOSIN HYDROCHLORIDE MONOHYDRATE
### A II 9/11/1997 MOREPEN LABORATORIES LTD LORATADINE
### I III 8/28/1997 LOPAREX BV FL2000TM 80UM HDPE (PRODUCT CODE 78-080-
A-020-B)
### I II 9/15/1997 DSM ANDENO GMBH TRIAZOLON
### A III 8/6/1997 WEBER INTERNATIONAL PACKAGING PHARMACEUTICAL PLASTIC BOTTLES
CORP
### I III 8/9/1997 ELM PLASTIC GMBH DOSING PIPETTE
### I II 9/11/1997 FINE CHEMICALS CORP CODEINE PHOSPHATE
### A II 9/10/1997 SYN-TECH CHEM AND PHARM CO LTD DICLOFENAC POTASSIUM USP
### A III 9/22/1997 BPREX HEALTHCARE OFFRANVILLE SAS
EYE-DROPPER 5, 11 AND 15ML, DROPPERS,
CAPS
### I III 9/19/1997 SABIC PETROCHEMICALS BV SABIC LDPE 2102TC32
### A II 9/18/1997 AMRI RENSSELAER INC TRIENTINE HCL USP
### I III 8/8/1997 DANAPAK FLEXIBLES AS PHARMACEUTICAL COMPONENT
### A II 9/19/1997 JOHNSON MATTHEY PHARMACEUTICAL ALFENTANIL HCL
MATERIALS
### A II 9/20/1997 FARMABIOS SPA MEGESTROL ACETATE
### I III 9/1/1997 3M DRUG DELIVERY SYSTEMS DIV METERED DOSE AEROSOL VALVE
### I III 9/19/1997 AXIALL LLC PVC COMPOUND, 8271 CLEAR 36
### I II 9/23/1997 SHASUN CHEMICALS AND DRUGS LTD RANITIDINE HYDROCHLORIDE
### A III 9/26/1997 INEOS CHLORVINYLS BELGIUM NV NORVINYL S 5702
### I II 9/26/1997 FINE ORGANICS LTD TVSE
### I III 9/10/1997 PLASTICOS ARCO IRIS SA DE CV PLASTIC MATERIALS
### I II 9/22/1997 WANBURY LTD IBUPROFEN BULK DRUG
### A II 9/30/1997 MERCK SANTE SAS METFORMIN HYDROCHLORIDE DRUG
SUBTANCE
### I II 9/29/1997 YAMASA CORP SODIUM CITICOLINE
### I II 9/23/1997 SINOVA PHARMACEUTICALS CO PTE CAPTOPRIL
LTD
### I II 10/1/1997 KIBUN FOOD CHEMIFA CO LTD PLANT FACILITIES AND ORGANIZATION FOR
MANUFACTURING SODIUM HYALURONATE OF
PHARMACEUTICAL GRADE IN TOKYO, JAPAN.
Page 412
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 10/1/1997 KIKKOMAN BIOCHEMIFA CO SODIUM HYALURONATE OF PHARMACEUTICAL
GRADE
### I III 9/30/1997 DRYCOLOR AB MASTERBATCH PE 142306
### I II 10/1/1997 PRODOTTI CHIMICI DOTTORI RE CHENODIOL, (CHENODEOXYCHOLIC ACID)
### I III 10/3/1997 SCHOTT PARENTA SYSTEMS PACKAGING MATERIAL, PREFILL SYRINGE, A
COMBONATION PRODUCT
### I III 9/29/1997 CLARIANT CORP WPC-116-P 33/1 WHITE COLOR CONCENTRATE
### I II 10/2/1997 CAMBREX KARLSKOGA AB ISOSORBIDE-5-MONONITRATE/LACTOSE
### I II 10/2/1997 SIFAVITOR SRL BETAXOLOL HYDROCHLORIDE
### I III 9/30/1997 3M PHARMACEUTICALS NON-CLINICAL PHARMACOLOGY TOXICOLOGY
STUDIES ON HYDROXYPROPYL-BETA-
CYCLODEXTRIN (ENCAPSIN HPB)
### I V 6/16/1997 BRISTOL MYERS SQUIBB CO FACILITIES FOR PARENTERAL MANUFACTURING
(BUILDING D) LOCATED IN MAYAGUEZ, PR.
Page 414
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 11/11/1997 AMCOL HEALTH AND BEAUTY FLUOROURACIL IN MICROSPONGE® POLYMER
SOLUTIONS INC (FLUROURACIL IN METHYL
METHACRYLATE/DIMETHACRYLATE
CROSSPOLYMER)
### I III 10/29/1997 DUPONT POLYESTER FILMS MELINEX 813
### I II 11/13/1997 FINORGA SAS N-(2-DEOXY-2-L-LEUCYLAMINO-B-D-
GLUCOPYRANOSYL)-N-OCTADECYL-
DODECANAMIDE
### I II 10/10/1997 ORPHARM INC LEVOMETHADYL ACETATE HYDROCHLORIDE
(LAAM HCL)
### A III 11/12/1997 CENTER PACKAGING INC CP 20 PRESSURE SENSITIVE INNERSEAL LINER
### I III 11/12/1997 COURTALDS PACKAGING LTD OPHTHALMIC BOTTLES
### A IV 11/14/1997 ACG ASSOCIATED CAPSULES PVT LTD EXCIPIENT HARD GELATIN CAPSULES SHELLS
### I II 11/14/1997 ABBOTT LABORATORIES HOSP MIDAZOLAM
PRODUCTS DIV
### A II 11/18/1997 TARO PHARMACEUTICAL INDUSTRIES WARFARIN SODIUM CLATHRATE USP
LTD
### I II 11/17/1997 CATALENT PHARMA SOLUTIONS LLC RITONAVIR, 100MG AND 200MG SOFT-GELATIN
CAPSULE
### A III 11/12/1997 CENTER PACKAGING INC CP 40 PRESSURE SENSITIVE INNERSEAL LINER
### A II 11/18/1997 FARMABIOS SPA BETAMETHASONE VALERATE
### A II 11/14/1997 DR REDDYS LABORATORIES LTD DOXAZOSIN MESYLATE USP
### I III 10/10/1997 PECHINEY SOPLARIL FLEXIBLE EUROPE COLD-FORMED BLISTER: CEF 100
Page 420
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 4/1/1998 ASH STEVENS INC SS-2'-DEOXY-5-FLUOROURIDINE A
PHARMACEUTICAL INGREDIENT
### A II 4/2/1998 TEVA PHARMACEUTICAL INDUSTRIES CYCLOSPORINE
LTD
### I II 3/31/1998 SMITHKLINE BEECHAM 6-AMINOPENICILLANIC ACID [6-APA]
### I II 3/20/1998 YANGZHOU PHARMACEUTICAL LEVONORGESTREL USP 23
FACTORY
### I II 4/3/1998 MIPHARM SPA MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
MILANO, ITALY
### I III 3/24/1998 RESCO COLOURS INC 78MPT-466
### A II 4/3/1998 MSD INTERNATIONAL GMBH BETAMETHASONE, USP
(SINGAPORE BRANCH)
### A II 4/8/1998 CATALENT PHARMA SOLUTIONS LLC MICONAZOLE NITRATE (1,200MG) VAGINAL
OVULE SOFT-GELATIN CAPSULE
### I II 4/8/1998 GEDEON RICHTER LTD ENALAPRIL MALEATE
### I III 4/9/1998 DSM RESINS US INCORPORATED URAVER FB120 B-60
### I III 4/8/1998 WEST PHARMACEUTICAL SERVICES INC LYODRY DESICCANT STOPPER
Page 421
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 4/24/1998 ZHEJIANG HISUN PHARMACEUTICAL CO BLEOMYCIN SULFATE USP
LTD
### I IV 4/20/1998 AMPACET CORP 160638-A BLUE PA POLYETHYLENE
MASTERBATCH
### A II 4/27/1998 PCAS CLONIDINE BASE
### I III 4/22/1998 ZELLER PLASTIK GMBH SCREW CLOSURE ND 20 WITH ZELSNAP SNAP
HINGE
### A IV 2/3/1998 MINGTAI CHEMICAL CO LTD COMPRECEL MICROCRYSTALLINE CELLULOSE,
S M101, M102 ,M112, M113, M112D+ & M113D+
Page 422
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 5/11/1998 ZHEJIANG HISUN PHARMACEUTICAL CO CLONAZEPAM, USP
LTD
### I II 5/11/1998 LONZA LTD 2-BUTYL-3-H-IMIDAZOL-4-CARBALDEHYDE
(IMALOC SB 202783)
### I II 5/15/1998 SUZHOU NUMBER 4 PHARMACEUTICAL CLINDAMYCIN ISOPROPYLIDENE,
FACTORY INTERMEDIATE
### I II 5/15/1998 SIEGFRIED USA LLC METHYLPHENIDATE HYDROCHLORIDE USP
### A II 5/5/1998 PRIME EUROPEAN THERAPEUTICALS 31/AC HCL
SPA (EUTICALS SPA)
### I II 5/18/1998 SANOFI SYNTHELABO INC SUCCIMER (MESO-2,3-DIMERCAPTOSUCCINIC
ACID)
### A II 5/15/1998 PMC ISOCHEM AMINOPYRROLAMIDE
### A III 4/30/1998 KUTTERER MAUER AG CAPS, SHOULDERS AND CLOSURES MADE
FROM PLASTIC MATERIAL/RESINS
### I II 5/18/1998 HUBEI PHARMACEUTICAL FACTORY LEVONORGESTREL, USP
### I II 5/15/1998 BACHEM AG PEPTIDE P829 (DEPREOTIDE)
TRIFLUOROACETATE
### I I 5/19/1998 SHANGHAI SHEN XING MANUFACTURING SITE, FACILITIES,
PHARMACEUTICAL FACTORY PERSONNEL AND OPERATING PROCEDURES IN
SHANGHAI, CHINA
### A II 5/21/1998 IDT AUSTRALIA LTD ACETAZOLAMIDE USP
### I II 5/22/1998 CHEMI SPA DMPC (DIMYRISTOYL-PHOSPHATIDYLCHOLINE)
### A II 5/21/1998 COSMA SPA OXAPROZIN
### A IV 5/19/1998 LIPOID GMBH LIPOID PC 16:0/16:0 (1.2-DIPALMITOYL-SN-
GLYCERO-3-PHOSPHOCHOLINE)
### I II 5/19/1998 LIPOID GMBH LIPOID PC 16:0/16:0 (1,2-DIPALMITOYL-SN-
GLYCERO-3-PHOSPHO CHOLINE)
### I II 5/26/1998 JOHNSON MATTHEY INC AMD 3100
### I II 5/26/1998 BORREGAARD AS BORREGAARD BFI BULK INTERMEDIATE
SYNTHESIS
### A II 5/27/1998 DYNAMIT NOBEL GMBH SR 47436 (CRUDE)
EXPLOSIVSTOFF UND SYSTEMTECHNIK
### I II 5/28/1998 NEW CONCEPT THERAPEUTICS INC B-ENRICHED L-P-BORONPHENYLALANINE
### A II 5/28/1998 RELIABLE BIOPHARMACEUTICAL LLC CLADRIBINE
### I II 5/28/1998 NEW CONCEPT THERAPEUTICS INC 10B ENRICHED P-BORONOPHENYLALANINE
### I II 5/29/1998 PHARMACIA AND UPJOHN SPA 9-AMINOCAMPTOTHECIN COLLOIDAL
DISPERSION
### A II 5/25/1998 SANDOZ GMBH CTAZ.DH (=CEFTAZIDIME DIHYDROCHLORIDE)
### A II 6/1/1998 ERREGIERRE SPA PROPAFENONE HYDROCHLORIDE USP-EP
13011 I II 5/26/1998 FUJISAWA PHARMACEUTICAL CO LTD FK 960
### A II 5/28/1998 QUIMICA SINTETICA SA ITRACONAZOLE
### I II 6/5/1998 FARMABIOS SRL BUDESONIDE
### A III 6/2/1998 SARTORIUS STEDIM FMT SAS STEDIM 71 BAGS FOR HUMAN DRUGS AND
BIOLOGICS PACKAGING
### I II 6/10/1998 MCNEIL CONSUMER HEALTHCARE NICOTINE PURIFICATION PROCESS
Page 423
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 6/11/1998 CSF BIOTECH PACLITAXEL
### I II 6/11/1998 NEXTRAN INC TRISACCHARIDE FREE ACID (TRFA)
### I II 6/10/1998 ZACH SYSTEM SPA SULINDAC SULFONE
### A II 6/12/1998 EUTICALS SPA MECAMYLAMINE BASE
### I III 6/11/1998 AMPACET CORP 110849 WHITE HD POLYETHYLENE
MASTERBATCH
### A II 6/15/1998 TARO PHARMACEUTICAL INDUSTRIES CLOMIPRAMINE HYDROCHLORIDE USP
LTD
### I II 6/11/1998 SAFC BIOSCIENCES INC EX-CELL 301 COMPLETE MEDIUM (MODIFIED)
### I II 6/12/1998 WUJING CHANGXIN BIOCHEMISTRY HUMAN MENOPAUSAL GONADOTROPIN
FACTORY
### I II 6/12/1998 NANJING CHENGHONG BIOCHEMICAL HUMAN CHORIONIC GONADOTROPIN
FACTORY
### I II 6/17/1998 GEDEON RICHTER PLC 17-DEACETYL NORGESTIMATE
### I II 6/16/1998 BASF PHARMACHEMIKALIEN GMBH CO FLUOXETINE HYDROCHLORIDE
KG
### I II 6/17/1998 TACONIC BIOTECHNOLOGY ANTIBODY RELATED REAGENTS
### I III 6/15/1998 TENNECO PACKAGING FILMS LTD MONO PVC FILMS
### I II 6/15/1998 AUSIMONT USA INC POLYMIST F5A TSP
### A II 6/18/1998 KISSEI PHARMACEUTICALS CO LTD KMD-3213 (SILODOSIN) DRUG SUBSTANCE
### I IV 6/17/1998 BORCULO DOMO INGREDIENTS LACTOCHEM
### A II 6/18/1998 MSD INTERNATIONAL GMBH LORATADINE
### I III 6/17/1998 HELVOET PHARMA MARYLAND RUBBER CLOSURE FORMULATION B5001-BLUE
3XD
### I II 6/16/1998 CUNO INC ZETAPOR 020ST
### I II 6/17/1998 JINZHOU JIUTAI PHARMACEUTICAL CO PARACETAMOL
LTD
### A II 6/17/1998 QUIMICA SINTETICA SA FAMOTIDINE
### I II 6/15/1998 SHANGHAI TONGREN IVERMECTIN
PHARMACEUTICAL CO LTD
### A III 6/11/1998 BASELL POLIOLEFINE ITALIA SRL POLYPROPYLENES HOMOPOLYMERS,
COPOLYMERS AND TERPOLYMERS
### A II 6/22/1998 APOTEX PHARMACHEM INDIA PVT LTD DOXAZOSIN MESYLATE USP
### I II 6/25/1998 KUNSHAN ORIENTAL PHARMACEUTICAL DOXYCYCLINE USP, NON-STERILE BULK DRUG
CO LTD
### I III 6/10/1998 POLIMERI EUROPA SPA FLEXIRENE CM50
### I II 6/24/1998 JOHNSON MATTHEY PHARMACEUTICAL 1-(MERCAPTOMETHYL)CYCLOPROPYL ACETIC
MATERIALS ACID (TAD)
### I III 6/22/1998 SHELL CHEMICAL CO SOLID EPOXY RESINS
### I V 6/24/1998 PATHEON MANUFACTURING SERVICES STERILE PRODUCT OPERATION-SOUTH (SPO-
LLC SOUTH) IN GREENVILLE NORTH CAROLINA
### A II 6/26/1998 DIPHARMA FRANCIS SRL DICLOFENAC POTASSIUM
### I III 7/28/1998 TARGOR UK LTD SPECIALITIES HOSTACOM D1124 NATURAL 001
### I II 6/28/1998 ALDRICH CHEMICAL CO INC RHODAMINE 123
### A III 6/29/1998 INEOS ABS USA CORP LUSTRAN ABS 348-VARIOUS COLORS
Page 424
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 6/30/1998 AVECIA BIOTECHNOLOGY INC OLIGONUCLEOTIDE 2006 A PHARMACEUTICAL
INGREDIENT
### I II 7/2/1998 LIANYUNGANG PHARMACEUTICAL CYCLOPHOSPHAMIDE USP,NON-STERILE BULK
FACTORY DRUG
### I III 7/2/1998 ISHIDA PRESS KOGYO CO LTD ALUMINUM CAPS FOR MEDICAL VIALS
### I II 7/2/1998 H LUNDBECK AND CO AS LU 28-179-C, DRUG SUBSTANCE
### I II 7/2/1998 H LUNDBECK AND CO AS LU 28-179-CAPSULES
### A III 7/2/1998 INGE SPA PLASTIC PACKAGING
### A II 6/29/1998 MEDICHEM SA ENALAPRIL MALEATE
### I IV 7/7/1998 MITSUBISHI CHEMICAL CORP SUCROSE FATTY ACID ESTERS-SUCROSE
STEARIC ACID ESTERS AND SUCROSE PALMITIC
ACID ESTERS
### I II 7/6/1998 TAKASAGO INTERNATIONAL CORP MANUFACTURING SITE, FACILTIES, PERSONNEL
AND OPERATIONAL PROCEDURES IN SHIZUOKA
PREFECTURE, JAPAN
### I II 7/6/1998 TAKASAGO INTERNATIONAL CORP [2R-[2A,5A,6A(R
### I V 6/23/1998 EUROPEAN ORGANIZATION FOR PERSONNEL AND PROCEDURES FOR THE
RESEARCH AND TREATMENT OF DEVELOPMENT OF ANTI-CANCER AGENTS AND
CANCER OTHER MODALITES IN CLINICAL TRIALS IN
BRUSSELS, BELGIUM
### I II 7/7/1998 CATALENT FRANCE BEINHEIM SA AMPRENAVIR 50 AND 150 MG SOFT GELATIN
CAPSULES
### A II 7/7/1998 BAYER AG GADOBUTROL
### I II 3/24/1998 POLIMERI EUROPA FRANCE SA RIBLENE FL24
### A IV 7/7/1998 BAYER AG CALCIUMBUTROL
### A III 6/26/1998 FUJIMORI KOGYO CO LTD PLASTIC FILM FOR USE IN DRUG SUBSTANCE
AND PRODUCT CONTAINERS
### A IV 7/15/1998 MINGTAI CHEMICAL CO LTD COMPRECEL MICROCRYSTALLINE CELLULOSE,
S M200D+ M200 & M212
### A III 7/9/1998 PRINTAL OY ONE-PIECE ALUMINIUM CANS, BOTTLES AND
RIGID CONTAINERS
### A IV 7/7/1998 MEXICHEM UK LTD INHALATION GRADE 1,1,1,2-
TETRAFLUOROETHANE
### I I 6/26/1998 LANZHOU CHEMISTRY NATRUAL 4-DEMETHYL-EPIPODOPHYLLOTOXIN
PRODUCTS FACTORY
### A II 7/9/1998 DR REDDYS LABORATORIES LTD FLUOXETINE HYDROCHLORIDE, USP
### I II 7/15/1998 MITSUBISHI TANABE PHARMA CORP MCC-135 (BULK DRUG SUBSTANCE)
### I II 7/1/1998 BASF AKTIENGESELLSCHAFT 9-Z-ISOTRETINOIN
### I II 7/13/1998 SUN PHARMACEUTICAL INDUSTRIES CIPROFLOXACIN HYDROCHLORIDE USP
LTD
### A II 7/7/1998 JIANGSU TIANHE PHARMACEUTICAL CO SULFADIMETHOXINE
LTD
### A II 7/17/1998 ISHIHARA SANGYO KAISHA LTD CEVIMELINE HYDROCHLORIDE
### A III 7/16/1998 INTRAPAC CORP METERED DOSE INHALER CANS INTERNALLY
COATED WITH FLUOROPOLYMER
Page 425
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 7/20/1998 BORMIOLI PHARMA SPA HDPE BOTTLE 40 ML
### I III 7/10/1998 POLIMERA EUROPA SRL ERACLENE MM 74
### I III 7/10/1998 POLIMERA EUROPA SRL RIBLENE FC 40
### A III 7/15/1998 ILC DOVER LP FLEXIBLE CONTAINMENT DEVICE USED TO
STORE A PHARMACEUTICAL INGREDIENTS
(BULK DRUG SUBSTANCE)
### A II 7/17/1998 CHUNGHWA CHEMICAL SYNTHESIS AND METHOCARBAMOL USP
BIOTECH CO LTD
### I IV 7/21/1998 CERESTAR USA INC HYDROXYPROPYL BETA CYCLODEXTRIN
### A II 7/8/1998 ZHEJIANG CANDORLY CLINDAMYCIN PHOSPHATE U.S.P.
PHARMACEUTICAL CO LTD
### I II 7/21/1998 ERREGIERRE SPA SOTALOL HYDROCHLORIDE
### A II 7/22/1998 PCAS OXYBUTYNIN BASE
### I II 7/20/1998 CUNO INC ZETA PLUS DELIPID PLUS
### A II 7/21/1998 ERCROS SA FAMOTIDINE
### A II 7/24/1998 CHEMWERTH INC INAMRINONE USP, NON-STERILE BULK DRUG
INTENDED FOR HUMAN USE
### A III 7/22/1998 NOLATO JAYCARE LTD 500ML/750ML ROUND HDPE BOTTLE
### I II 7/21/1998 DIPHARMA SPA SULINDAC, MANFACTURED IN MERETO DI
TOMBA (UD), ITALY
### A II 7/27/1998 PURESYN INC POLYFLO RESIN
### A II 7/23/1998 CLARIANT PRODUKTE DEUTSCHLAND MACROGOLS (INN)=POLYETHYLENE GLYCOLS
GMBH (NF),
### A II 7/10/1998 SHANDONG XINHUA PHARMACEUTICAL CAFFEINE ANHYDROUS
CO LTD
### I II 7/27/1998 NV ORGANON PORCINE INSULIN HIGHLY PURIFIED
### I II 7/28/1998 DIOSYNTH BV ORG 9487
### I III 7/22/1998 INEOS ABS USA CORP LUSTRAN SAN 32 20010, LUSTRAN SAN 29 20029
### A III 7/22/1998 INEOS ABS USA CORP 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
### I III 7/27/1998 PHARMACEUTICAL AND MEDICAL HIGH DENSITY POLYETHYLENE RESIN (165770)
PLASTICS INC
### I II 7/24/1998 SF CHEM 2-BROMO-4'-(METHLSULFONYL)
ACETOPHENONE, (BROMOSULFONE)
### I II 7/31/1998 RANBAXY LABORATORIES LTD 7-AMINO-3-CHLORO-3-CEPHEM-4-CARBOXYLIC
ACID
### I II 7/30/1998 BIONEBRASKA INC RECOMBINANT HUMAN GROWTH HORMONE
RELEASING FACTOR (RGRF)
### A II 7/30/1998 AMSA SPA GLIPIZIDE
### A IV 7/29/1998 DMV-FONTERRA EXCIPIENTS GMBH AND HMS LACTOSE DT AND PHARMATOSE® DCL 15
CO KG
Page 426
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 7/26/1998 CHAICHEM PHARMACEUTICALS PACITAXELINE
INTERNATIONAL INC
### I II 7/31/1998 CHEMI SPA DMPG. NA (DIMYRISTOYL-
PHOSPHATIDYLGLYCEROL)
### I II 7/30/1998 RECORDATI INDUSTRIA CHIMICA E NABUMETONE
FARMACEUTICA SPA
### I II 7/6/1998 QUIMICA SINTETICA SA BUTOCONAZOLE NITRATE
### I II 8/5/1998 BIOIBERICA SA CHONDROITIN SULFATE SODIUM
### I II 8/3/1998 NIPPON SYNTHETIC CHEMICAL TBHI
INDUSTRY CO LTD
### I III 8/3/1998 LOPAREX BV FL20000 100 MICRON PET EASY/EASY PRODUCT
CODE 78-100-A-320-B OR 7CF
13110 I III 8/3/1998 BASELL POLIOLEFINE ITALIA SPA LUPOLEN 2420 K
13111 I II 8/5/1998 AVANTI POLAR LIPIDS INC 1,2-DIOLEOYL-SN-GLYCERO-3-
PHOSPHOETHANOLAMINE-N-GLUTARYL
13112 I II 8/5/1998 KYOWA HAKKO KIRIN CO LTD KRN5500 DRUG SUBSTANCE
13113 I II 8/4/1998 APTE AMALGAMATIONS LTD SULFAMETHOXAZOLE
13114 I II 8/6/1998 LEK PHARMACEUTICALS DD ENALAPRIL MALEATE, A SUBSTANCE
13115 I II 8/7/1998 CHINA CHEMICAL SYNTHESIS NIFEDIPINE USP, (BULK A PHARMACEUTICAL
INDUSTRIAL CO LTD INGREDIENT), MANFACTURED IN TAIWAN, THE
REPUBLIC OF CHINA
13116 A III 8/3/1998 ISO-GESELLSCHAFT FUR PACKAGING MATERIAL
ARZNEIVERPACKUNGEN MBH
13117 I III 8/6/1998 WEDTECH INC WEDTECH 1005 WHITE FOR USE IN PACKAGING
MATERIALS
13118 I III 8/6/1998 INGENIA POLYMERS CORP WEDTECH WT-157 WHITE FOR USE IN
PACKAGING MATERIALS
13119 I II 8/11/1998 CHINA CHEMICAL SYNTHESIS OXAPROZIN (BULK A PHARMACEUTICAL
INDUSTRIAL CO LTD INGREDIENT)
### I IV 8/11/1998 FONA INTERNATIONAL INC 840.042 NATURAL FLAVOR,(CREAM )
### I IV 8/11/1998 FONA INTERNATIONAL INC 884.114 N-C NATURAL & ARTIFICIAL ORANGE
FLAVOR
### I IV 8/11/1998 FONA INTERNATIONAL INC 877.038 N-C NATURAL MINT FLAVOR
### I IV 8/11/1998 FONA INTERNATIONAL INC 894.037 N-C NATURAL PEPPERMINT FLAVOR
### I II 7/27/1998 JINZHOU JIUTAI PHARMACEUTICAL CO CHLORHEXIDINE ACETATE
LTD
### I II 8/11/1998 TEVA GROUP CARBAMAZEPINE USP
### I II 8/11/1998 LIPOMED AG AG14-35 (VICUREX)
### I II 8/12/1998 EVONIK TECHNOCHEMIE GMBH CLOMIPRAMINE HYDROCHLORIDE
### I V 8/12/1998 ASTA MEDICA INC TOXICOLOGY INFORMATION FOR PERIFOSINE
(D-21266)
### I IV 8/13/1998 SANWA STARCH CO LTD CRYSTALLINE MALTOSE
### I II 8/12/1998 NATCO PHARMA LTD DILTIAZEM HYDROCHLORIDE, USP
### I III 8/7/1998 ARTSANA SPA PACKAGING MATERIAL
### A II 8/12/1998 SPECGX LLC METHYLPHENIDATE BASE
Page 427
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 8/14/1998 ELAN DRUG DELIVERY INC RITALIN QD (METHYLPHENIDATE) ONCE DAILY
CAPSULES
### A V 8/17/1998 FRESENIUS KABI NORGE AS STERILE MANUFACTURING OPERATIONS IN
HALDON, NORWAY
### I II 8/14/1998 INSTITUTE DRUG TECHNOLOGY LOXAPINE BASE
AUSTRALIA LTD
### I V 10/9/1998 PHARMACIA AND UPJOHN TOXICOLOGY INFORMATION FOR
IODODOXORUBICIN HCL
### I II 8/7/1998 ENDURA SPA PIPERONYL BUTOXIDE
### I III 8/6/1998 INGENIA POLYMERS CORP WT-152 WHITE (WHITE COLOUR CONCENTRATE)
### I III 8/6/1998 INGENIA POLYMERS CORP WT-153 WHITE (WHITE COLOUR CONCENTRATE)
### I III 8/14/1998 B BRAUN MEDICAL INC 250 ML STERILE FLEXIBLE I.V. CONTAINER, PART
NUMBER 80-203
### I II 8/18/1998 DEGUSSA AG WERK RADEBEUL KETAMINE HYDROCHLORIDE
### I II 8/18/1998 ASH STEVENS INC PREPARATION OF N-(2-PYRAZINECARBONYL)-L-
PHENYLALANINE-L-LEUCINE BORONIC ACID
BULK DRUG SUBSTANCE
### I III 7/13/1998 MUNNERSTADTER GLASWARENFABRIK ARTICLES OF TUBULAR GLASS USED AS
GMBH CONTAINERS
### A II 8/18/1998 SHANDONG XINHUA PHARMACEUTICAL TRIMETHOPRIM USP
CO LTD
### I II 8/20/1998 PFANSTIEHL LABORATORIES INC D-GLUCOSAMINE HYDROCHLORIDE, HIGH
PURITY
### I II 8/18/1998 NEOMPS INC MBI 226, A SYNTHETIC PEPTIDE
### I II 8/18/1998 MULTIPLE PEPTIDE SYSTEMS MPS-35, A SYNTHETIC PEPTIDE
### I II 8/21/1998 CHONGQING UNIT MODERN PACLITAXEL
TECHNOLOGY CO LTD
### A IV 8/25/1998 ROTEM AERT NEGEV LTD EXCIPIENT, WHITE PHOSPHORIC ACID
### A II 8/21/1998 POLYPEPTIDE LABORATORIES INC LEUPROLIDE
### I II 8/24/1998 VALEANT PHARMACEUTICALS NORTH MOGADON (NITRAZEPAM) TABLETS
AMERICA
### A II 8/25/1998 ISO TEX DIAGNOSTICS INC INDIUM-111
### A III 8/21/1998 NEMERA LE TREPORT PHARMACEUTICALS PACKAGING MATERIALS,
PUMPS AND DEVICES
### I III 8/26/1998 POLYTECH KUNSTSTOFF GMBH PACKAGING MATERIALS FOR HDPE BOTTLE 950
ML
### I II 8/26/1998 REPLIGEN CORP IMMOBLIZED (R) PROTEIN (A) TM, IPA-500
### A IV 8/15/1998 MINGTAI CHEMICAL CO LTD COMPRECEL MICROCRYSTALLINE CELLULOSE,
S M301D+ M302D+M301 & M302
### I II 8/27/1998 AMYLIN PHARMACEUTICALS INC EXENDIN-4 INJECTION DRUG PRODUCT
### I II 6/23/1998 AJINOMOTO CO INC MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
YOKKAICHI, MIE PREFECTURE, JAPAN
Page 428
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 8/28/1998 SABIC PETROCHEMICALS BV SABIC LDPE 2101TN47 POLYETHYLENE
### A II 8/27/1998 ISO TEX DIAGNOSTICS INC PLATINUM-195M (PT-195M)
### I II 8/26/1998 SIEGFRIED CHEMICALS INC VALPROIC ACID
### A II 9/1/1998 SIGMA ALDRICH MANUFACTURING LLC L-A-PHOSPHATIDYLCHOLINE DIPALMITOYL
### A IV 8/31/1998 LIPOID GMBH LIPOID PA 16:0/16:0 (1,2-DIPALMITOYL-SN-
GLYCERO-3-PHOSPHATIDIC ACID MONOSODIUM
SALT)
### A III 9/1/1998 BOXMORE PLASTICS LTD PLASTIC CONTAINERS
### I II 9/2/1998 APTE AMALGAMATIONS LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
MAHARASHTRA STATE, INDIA
### I II 9/2/1998 APOTEX PHARMACHEM INC TERAZOSIN HCI DIHYDRATE
### A III 8/31/1998 LAGEEN TUBOPLAST LTD ALUMINUM TUBES AND CAPS
### A III 9/2/1998 SARTORIUS STEDIM FMT SAS STEDIM 40 BAGS FOR HUMAN DRUGS AND
BIOLOGICS PACKAGING
### A II 9/1/1998 AMPAC FINE CHEMICALS LLC CARMUSTINE (BCNU)
### I III 8/27/1998 ALBIS PLASTIC GMBH LUPOLEN 1840 H WHITE 99950
### I III 9/4/1998 ABBOTT LABORATORIES FORM FILL SEAL FLEXIBLE CONTAINER
### I II 9/4/1998 AVANTI POLAR LIPIDS INC 1,2-DIOLEOYL-SN-GLYCERO-3-[PHOSPHO-RAC-
(1-GLYCEROL)](DOPG)
### A II 8/6/1998 CRYSTAL PHARMA SAU PREDNISONE ANHYDROUS USP,
### A II 9/10/1998 YANGZHOU PHARMACEUTICAL CO LTD DOXYCYCLINE HYCLATE
### I IV 8/25/1998 FONA INTERNATIONAL INC #862.378 LEMON FLAVOR, NATURAL (WONF)
### I IV 7/30/1998 KERRY INC DBA MASTERTASTE INC NAT & ART VANILLA FLAVOR 601444
### I II 9/10/1998 ADVANCED SYTHESIS TECHNOLOGIES MANUFACTURING SITE, FACILITIES,
SADE CV PERSONNEL AND OPERATING PROCEDURES IN
TIJUANA, MEXICO
### I II 9/4/1998 MEDICHEM SA GABAPENTIN, DRUG SUBSTANCE
### I II 9/8/1998 YAMAMOTO CHEMICAL INDUSTRIES CO FLAVOXATE HYDROCHLORIDE JP XIII
LTD
### I II 9/9/1998 PROMETIC BIOSCIENCES LTD DECYL AGAROSE 6XL
### I II 9/10/1998 ST PHARM CO LTD ZIDOVUDINE DRUG SUBSTANCE
### I II 9/17/1998 DAIICHI PHARMACEUTICAL CO LTD DX-9065A
### I II 9/10/1998 YANGZHOU PHARMACEUTICAL METHACYCLINE
FACTORY
### I I 9/14/1998 VIRCHOW LABORATORIES LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
HYDERBAD, INDIA
### A II 9/14/1998 VIRCHOW LABORATORIES LTD SULFAMETHOXAZOLE USP
### I II 9/14/1998 HEUMANN PHARMA GMBH SOTALOL HYDROCHLORIDE
### I III 9/15/1998 GRAHAM PACKAGING CO LP PLASTIC CONTAINERS
### A II 9/11/1998 MACFARLAN SMITH LTD APOMORPHINE HYDROCHLORIDE
### A II 9/8/1998 CORDEN PHARMA SWITZERLAND LLC 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOPHATIDIC
ACID SODIUM SALT (DPPA, NA)
### A IV 8/25/1998 ROTEM AERT NEGEV LTD MONOBASIC POTASSIUM PHOSPHATE
Page 429
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 9/18/1998 NIPPON SYNTHETIC CHEMICAL 2-N-BUTYL-1H-IMIDAZOLE-4-CARBOXALDEHYDE
INDUSTRIES (BFI)
### A II 9/21/1998 SOLARA A PHARMA SCIENCES LTD NIZATIDINE
### I II 9/22/1998 ARCHIMICA SPA AMRINONE, USP
### I II 9/23/1998 TEVA PHARMACEUTICAL FINE TERAZOSIN HCI 2H20
CHEMICALS SRL
### A II 9/23/1998 CHEMWERTH INC MILRINONE, NON-STERILE BULK DRUG
### I V 9/21/1998 STERIS APPLIED STERILIZATION CONTRACT STERILIZATION FACILITY IN
TECHNOLOGIES GROVEPORT OHIO
### A II 4/30/1998 ABBVIE INC ERYTHROMYCIN BASE
### I II 4/30/1998 GIST-BROCADES NV PENICILLIN G PROCAINE
PHARMACEUTICALS
### I II 4/30/1998 CULTOR FOOD SCIENCE INC POLYMYXIN B SULFATE
### I II 4/30/1998 COMPANHIA INDUSTRIAL PRODUTORA OXYTETRACYCLINE
DE ANTIBIOTICOS SARL
### I II 4/30/1998 SMITHKLINE BEECHAM AMOXICILLIN TRIHYDRATE
### I II 4/30/1998 HOUBA INC DOXYCYCLINE HYCLATE
### I II 4/30/1998 BIOCHEMIE DEUTSCHLAND GMBH PENICILLIN G PROCAINE STERILE
### I II 4/30/1998 LILLY RESEARCH LABORATORIES ERYTHROMYCIN ESTOLATE
### A II 4/30/1998 ACS DOBFAR SPA CEFUROXIME SODIUM (STERILE BULK)
### I II 4/30/1998 ACS DOBFAR SPA CEPHALOTHIN SODIUM
### A II 4/30/1998 GLAXOSMITHKLINE LLC AMOXICILLIN TRIHYDRATE
### A II 4/30/1998 ACS DOBFAR SPA CEFAZOLIN SODIUM LYOPHILIZED (STERILE,
BULK)
### A II 4/30/1998 MEIJI SEIKA PHARMA CO LTD DOXORUBICIN HYDROCHLORIDE DRUG
SUBSTANCE
### A II 4/30/1998 DSM SINOCHEM PHARMACEUTICALS CEPHALEXIN MONOHYDRATE
NETHERLANDS BV
13211 A II 4/30/1998 MICROBIOPHARM JAPAN CO LTD DOXORUBICIN HYDROCHLORIDE
### A II 4/30/1998 SANDOZ INDUSTRIAL PRODUCTS SA AMPICILLIN ANHYDROUS
### I II 4/30/1998 TEVA PHARMACEUTICALS USA INC PENICILLIN V POTASSIUM
### A II 4/30/1998 LUPIN LTD RIFAMPIN USP
### I II 4/30/1998 SINTESIS QUIMICA AMOXICILLIN TRIHYDRATE
### I II 4/30/1998 SANDOZ INDUSTRIAL PRODUCTS SA OXACILLIN SODIUM
### I II 4/30/1998 LUPIN LTD CEFACLOR USP AS MAUFACTURED IN
MANDIDEEP, INDIA
### I II 4/30/1998 BRISTOL MYERS SQUIBB CO CEFACLOR
### A II 4/30/1998 LUPIN LTD STERILE CEFOTAXIME SODIUM USP
### I II 4/30/1998 HIKMACHEM BPC CEFADROXIL
### I II 4/30/1998 CONSOLIDATED PHARMACEUTICAL DICLOXACILLIN SODIUM
GROUP INC
### A II 4/30/1998 SPIC LTD PENICILLIN G POTASSIUM
### I II 4/30/1998 LEK PHARMACEUTICALS DD VANCOMYCIN HYDROCHLORIDE
### I II 4/30/1998 SHANGHAI ASIA PIONEER CO LTD AMPHOTERICIN B
### A II 4/30/1998 ACS DOBFAR SPA CEFADROXIL MONOHYDRATE
Page 430
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 4/30/1998 MIWON CEFACLOR MONOHYDRATE USP, NON-STERILE
BULK
### I II 9/21/1998 ZAMBON GROUP SPA OXAPROZIN
### A II 9/21/1998 SIEGFRIED USA LLC DEXMETHYLPHENIDATE HYDROCHLORIDE
### I II 9/22/1998 PHARM ECO LABORATORIES INC 2-NSA-FORMALDEHYDE CONDENSATE, SODIUM
SALT-FRACTIONED
### A II 9/24/1998 ALBEMARLE CORP PRAMOXINE HYDROCHLORIDE
### I IV 9/23/1998 NEKTAR THERAPEUTICS MPEG5000 DPPE
### I III 9/22/1998 AMPACET CORP 816030-P WHITE POLYETHYLENE
MASTERBATCH
### I IV 9/10/1998 SOLUTIA INC DEQUEST 2010 DEFLOCCULANT AND
SEQUESTRANT
### I II 9/22/1998 FLUOROMED LP PERFLUOROHEXANES, 99.0% (APF-60M)
### A II 9/25/1998 MOEHS IBERICA SL LIDOCAINE
### I II 9/1/1998 HEBEI ZHONGKANG PHARMACEUTICAL PENICILLIN G POTASSIUM CRUDE
COMPANY LTD
### I V 9/28/1998 STERIS ISOMEDIX SERVICES CONTRACT STERILIZATION FACILITY IN
TEMECULA,CALIFORNIA
### A V 9/28/1998 STERIS APPLIED STERILIZATION CONTRACT STERILIZATION FACILITY
TECHNOLOGIES
### I II 9/27/1998 AVANTI POLAR LIPIDS INC 1,2-DIARACHIDOYL-SN-GLYCERO-3-
PHOSPHOCHOLINE
### I II 9/25/1998 ARADIGM CORP AER INSULIN DIABETES MANAGMENT SYSTEM
### I II 9/28/1998 BIOSEPRA SA Q/S CERAMIC HYPERD ION EXCHANGERS
### I II 9/28/1998 BIOSEPRA SA DEAE CERAMIC HYPERD ION EXCHANGERS
### A II 10/1/1998 ZHEJIANG CHARIOTEER NAPROXEN SODIUM, USP (BULK)
PHARMACEUTICAL CO LTD
### I II 10/1/1998 SPI PHARMA INC DRIED ALUMINUM HYDROXIDE GEL, USP
### A II 9/30/1998 VIFOR INTERNATIONAL INC VENOFER® CONCENTRATE USA
### I III 10/1/1998 BAXTER PHARMACEUTICALS PACKAGING MATERIALS OF VIAL DRUG
SOLUTIONS LLC PRODUCTS
### I II 9/28/1998 AMERICAN INGREDIENTS INC AMGRAN
### I II 9/30/1998 ABBOTT LABORATORIES CHEMICAL AND LOVASTATIN, USP
AGRICULTURAL PRODUCTS DIV
### I II 9/30/1998 EVOTEC OAI PROSTAGLANDIN E
### A II 9/29/1998 NEULAND LABORATORIES LTD CIPROFLOXACIN HYDROCHLORIDE, USP
### A III 9/16/1998 BERRY GLOBAL PRODUCT 11173-40
### A III 9/16/1998 BERRY GLOBAL PRODUCT 41713-34
### I III 9/16/1998 GEORGIA PACKAGING INC PRODUCT 41762-34
### I II 10/2/1998 MAYNE PHARMA USA INC BLEOMYCIN SULFATE
### I II 10/2/1998 WOCKHARDT LTD FELODIPINE
### I V 10/1/1998 STERIS ISOMEDIX SERVICES CONTRACT STERILIZATION FACILITY IN VEGA
ALTA, PUERTO RICO
### I III 10/1/1998 BAXTER PHARMACEUTICALS PACKAGING MATERIALS OF SYRINGE DRUG
SOLUTIONS LLC PRODUCTS
Page 431
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 9/30/1998 HOSPIRA INC ALUER VIAL SUBASSEMBLY
### I III 10/7/1998 DSM RESEARCH ARNITAL E EM400
### I III 10/7/1998 DSM RESEARCH ARNITEL P PM380
### I III 10/7/1998 DSM RESEARCH ARNITEL P PL380
### I III 10/7/1998 DSM RESEARCH ARNITEL E EM460
### I III 10/7/1998 DSM RESEARCH ARNITEL P P-X6179
### I III 10/7/1998 DSM RESEARCH ARNITEL P PL460
### I II 10/8/1998 BRISTOL MYERS SQUIBB CO IRBESARTAN
### A II 10/5/1998 FIS FABBRICA ITALIANA SINTETICI SPA NITROFURANTOIN MONOHYDRATE
### I II 9/30/1998 OSAKA WORKS OF KOIE CHEMICAL CO MANUFACTURING SITE, FACILITIES,
LTD PERSONNEL AND GENERAL OPERATING
PROCEDURES IN OSAKA, JAPAN
### I II 6/4/1998 GENERAL ELECTRIC MEDICAL SYSTEMS FLUDEOXYGLUCOSE F-18 INJECTION
Page 435
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 9/1/1998 FERMENTACIONES Y SINTESIS SA DE TETRACYCLINE
CV
### I II 9/1/1998 GYMA LABORATORIES AMERICA INC TETRACYCLINE HYDROCHLORIDE
### I II 9/1/1998 NOVARTIS PHARMACEUTICALS CORP RIFAMPIN
### I II 9/1/1998 FARMITALIA CARLO ERBA SPA TETRACYCLINE
### I II 9/1/1998 PFIZER INC CARBENICILLIN INDANYL SODIUM
### I II 9/1/1998 GLAXO STREPTOMYCIN SULFATE
### I II 9/1/1998 GLAXO GROUP RESEARCH LTD DIHYDROSTREPTOMYCIN SULFATE
### I II 9/1/1998 FERMIC SA DE CV DEMECLOCYCLINE HYDROCHLORIDE
### I II 9/1/1998 LEDERLE LABORATORIES MINOCYCLINE HYDROCHLORIDE
### I II 9/1/1998 SMITHKLINE BEECHAM METHICILLIN SODIUM
PHARMACEUTICALS
### I II 9/1/1998 COMPANHIA INDUSTRIAL PRODUTORA ERYTHROMYCIN
DE ANTIBIOTICOS SARL
### I II 9/1/1998 PHARMACIA AND UPJOHN CO WHOLLY SPECTINOMYCIN HYDROCHLORIDE
OWNED SUB PFIZER INC
### I II 9/1/1998 BARCELONETA INC DIV BRISTOL MYERS AMPICILLIN TRIHYDRATE
Page 446
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 9/1/1998 ZHEJIANG HISUN PHARMACEUTICAL CO MITOMYCIN USP
LTD
### A II 9/1/1998 TEVA PHARMACEUTICAL INDUSTRIES BLEOMYCIN SULFATE
LTD
### I II 9/1/1998 MICROBIOPHARM JAPAN CO LTD MITOMYCIN
### A II 9/1/1998 TEVA PHARMACEUTICAL INDUSTRIES DAUNORUBICIN HYDROCHLORIDE
LTD
### A II 9/1/1998 CHONGQING CARELIFE CLINDAMYCIN HYDROCHLORIDE USP, NON
PHARMACEUTICAL CO LTD STERILE BULK DRUG SUBSTANCE
### A II 9/1/1998 CHONGQING DAXIN PHARMACEUTICAL AMIKACIN SULFATE (1:2) USP
CO LTD
### A II 9/1/1998 CHEMWERTH INC CYCLOSPORINE
### I II 9/1/1998 RANBAXY LABORATORIES LTD CEFACLOR
### A II 9/1/1998 TEVA PHARMACEUTICAL INDUSTRIES MITOMYCIN
LTD
### A II 9/1/1998 MYTHEN SPA DEMECLOCYCLINE HYDROCHLORIDE
### I II 9/1/1998 TEVA PHARMACEUTICALS USA INC CEPHRADINE
### A II 9/1/1998 XELLIA PHARMACEUTICALS LTD VANCOMYCIN HYDROCHLORIDE
### A II 9/1/1998 SANDOZ INDUSTRIAL PRODUCTS SA CLOXACILLIN SODIUM (NON-STERILE, BULK)
### A II 9/1/1998 OLON SPA RIFAMPIN
### I II 9/1/1998 ASTELLAS PHARMA INC CEFAZOLIN SODIUM (STERILE)
### A II 9/1/1998 SANDOZ INDUSTRIAL PRODUCTS SA DICLOXACILLIN SODIUM
### A II 9/1/1998 TEVA PHARMACEUTICAL INDUSTRIES CYCLOSPORINE
LTD
### A II 9/1/1998 ABBVIE INC CYCLOSPORINE USP
### A II 10/23/1998 OLON SPA FENOFIBRATE
### I II 10/21/1998 DIPHARMA SPA DIBENZOSUBERENONE
### I II 10/23/1998 AVECIA BIOTECHNOLOGY INC OLIGONUCLEOTIDE MG98 API
### I II 10/23/1998 SKYEPHARMA PLC MANUFACTURING SITE, FACILITIES,
OERSONNEL AND GENERAL OPERATING
PROCEDURES IN CEDEX, FRANCE
### I II 10/23/1998 SOLVAY SOLEXIS INC FOMBLIN Y25 TSP
### I II 10/30/1998 APTUIT INC MILRINONE DRUG SUBSTANCE
### I II 10/29/1998 BASF PHARMACHEMIKALIEN GMBH CO DOXAZOSIN MESYLATE
KG
### I II 9/30/1998 KOEI CHEMICAL CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
OSAKA, JAPAN
### I II 10/30/1998 BACHEM INC HUMAN GROWTH HORMONE RELEASING
FACTOR (1-44), AMIDE, ACETATE (BULK)
### A II 10/30/1998 FERMION OY DEXMEDETOMIDINE HYDROCHLORIDE
13811 I II 10/20/1998 INKE SA LORATADINE
### I IV 11/2/1998 LIPOID GMBH LIPOID PG 16:0/18:1-NH4 (1-PALMITOYL-2-
OLEOYL-SN-GLYCERO-3-PHOSPHATIDYL
GLYCEROL AMMONIUM SALT)
Page 447
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 10/26/1998 BERRY PLASTICS CORP PRODUCT 24-3-090
### I III 10/26/1998 MAC CLOSURES INC RECLOSABLE CONTINUOUS THREADED "LE"
STYLE STRIPPED CLOSURE
### A V 8/11/1998 STERIGENICS US LLC ELECTRON BEAM FACILITY IN SAN DIEGO, CA
### A III 11/2/1998 NEMERA BUFFALO GROVE LLC PACKAGING COMPONENTS FOR ASMANEX®
### I IV 11/4/1998 CENTRAL SOYA CO INC EXCIPIENTS (SOY LECITHIN, ETC.)
### A III 10/30/1998 HONEYWELL ACLAM LAMINATE STRUCTURES
### I II 11/5/1998 ASENCE PHARMA PRIVATE LTD AMPHOTERICIN B
### I II 11/5/1998 SUN PHARMACEUTICAL INDUSTRIES ENALAPRIL MALEATE USP
LTD
### I III 11/2/1998 HENKEL CORP MACROMELT 6900
### A II 11/6/1998 BACHEM AG LEUPROLIDE ACETATE
### I III 11/5/1998 CFC INTERNATIONAL INC PIGMENTED FOILS
### A IV 11/9/1998 WILD FLAVORS INC NATURAL PEPPERMINT FLAVOR WONF #112136
### I II 11/9/1998 PHARMACIA AND UPJOHN SPA IODODOXORUBICIN HCL BULK DRUG
SUBSTANCE
### I II 11/4/1998 HUIANG BIO CHEMICAL PRODUCT PACLITAXEL
MANUFACTURE COMPANY LTD
### I II 11/9/1998 TAPI PUERTO RICO INC METFORMIN HYDROCHLORIDE DRUG
SUBSTANCE
### I III 11/8/1998 ROPACK INC BULK DRUG PACKAGING AS LOCATED IN
QUEBEC, CANADA
### I III 11/9/1998 3M PHARMACEUTICALS D96171 SPRAYMISER VALVE
### I III 11/11/1998 HUMPHREY COSBURN PLASTICS PACKAGING FOR CYCLOSPORIN
### A II 11/5/1998 EUTICALS SPA PIRENZEPINE DIHYDROCHLORIDE
### A IV 11/19/1998 BAYER OY PDMS 372 TUBING
### I II 11/9/1998 ASAHI CHEMICAL INDUSTRY CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATIONAL PROCEDURES
IN TOKYO, JAPAN
### A IV 11/9/1998 ASAHI KASEI CORP MICROCRYSTALLINE CELLULOSE (USP/NF,
JP,Ph, Eur.)
### I II 11/9/1998 DR REDDYS LABORATORIES LTD ENALAPRILAT, USP
### A II 11/9/1998 DR REDDYS LABORATORIES LTD ENALAPRIL MALEATE, USP
### A II 11/12/1998 ISO TEX DIAGNOSTICS INC PT-195M CIS-PLATIN
### A II 11/12/1998 ISO TEX DIAGNOSTICS INC PLATINUM-195M
### I II 11/11/1998 MALLINCKRODT INC PROSAPTIDE TX 14(A), CODE 8200
### I III 11/12/1998 COURTAULDS PACKAGING LTD ALBUTEROL 300 DOSE ACTUATOR PROJECT
### A III 11/11/1998 ST GOBAIN PERFORMANCE PLASTICS POLYESTER/9022 FLUOROSILICONE RELEASE
COATING
### I II 11/12/1998 MEDICHEM SA LORATADINE
### A II 11/12/1998 CHATTEM CHEMICALS INC AMMONIUM LACTATE
### A II 11/19/1998 WAVELENGTH ENTERPRISES LTD GRANISETRON HYDROCHLORIDE
### I II 11/16/1998 ORGANICHEM CORP 4-METHOXYPHENOL
### A II 10/29/1998 BIDACHEM SPA MELOXICAM
### I III 11/18/1998 KOHAP LTD PAPET (TM) POLYESTER RESIN
Page 448
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 11/18/1998 PENINSULA LABS INC ALA-10-ASP
### I II 11/18/1998 PENINSULA LABS INC GLU-10-THR
### I II 11/18/1998 PENINSULA LABS INC ASP-10-GLU
### I II 11/16/1998 SOLMAG SPA BUPROPION HYDROCHLORIDE
### I II 11/19/1998 UCB SA PHARMACEUTIQUE SECTEUR HYDROXYZINE HYDROCHLORIDE COMPACTED
### I II 10/16/1998 SYNGEN BIOTECH CO LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
TAIWAN, R.O.C.
### A II 10/16/1998 STANDARD CHEM AND PHARM CO LTD DEXTROMETHORPHAN HYDROBROMIDE USP
### I IV 11/16/1998 LUBRIZOL ADVANCED MATERIALS INC CARBOPOL 1984, 2984 AND 5984 RESINS
### I II 11/10/1998 ESTEVE QUIMICA SA NEFAZODONE HYDRCHLORIDE
### I II 11/23/1998 JACOBUS PHARMACEUTICAL CO INC PROGUANIL HYDROCHLORIDE
### I II 11/23/1998 ZHEJIANG RUIBANG LABORATORIES INC CYCLOSPORINE
### I III 11/19/1998 REXAM CONSUMER PLASTICS INC ACTUATOR AND/OR STRAPCAP COMPONENTS
### I III 11/16/1998 AMPACET CORP WHITE POLYETHYLENE MASTERBATCH
### A II 11/25/1998 TARO PHARMACEUTICAL INDUSTRIES DESOXIMETASONE USP
LTD
### A II 11/24/1998 DR REDDYS LABORATORIES LTD CIPROFLOXACIN HYDROCHLORIDE, USP
### I II 11/25/1998 UNIV WISCONSIN FOOD RESEARCH PREPARATION OF BOTULINUM TOXINS A
INSTITUTE THROUGH G FOR MOUSE NEUTRALIZATION
ASSAYS
### A III 11/24/1998 ONGROPACK LTD ONGROFOL P-100 P-150 RIGID PVC FILM
### I II 11/24/1998 MALLINCKRODT INC PEMOLINE MALLINCKRODT CODE 1500
### A II 11/27/1998 DIVIS LABORATORIES LTD NAPROXEN USP
### A II 11/27/1998 DIVIS LABORATORIES LTD NAPROXEN SODIUM USP
### I II 11/25/1998 PROGEN INDUSTRIES PTY LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
DARRA, AUSTRALIA
### A II 11/24/1998 FARMHISPANIA SA METFORMIN HYDROCHLORIDE
### A II 11/27/1998 MALGRAT PHARMA CHEMICALS SLU DIPYRIDAMOLE
### I III 11/20/1998 POLIMERA EUROPA SRL RIBLENE FL20
### I III 11/25/1998 POLIMERI EUROPA FRANCE GREENFLEX FF 35
### I II 11/30/1998 LIPOID GMBH LIPOID PG 16:0/18:1-NH4 (1-PALMITOYL-2-
OLEOYL-SN-GLYCERO-3- PHOSPHATIDYL
GLYCEROL AMMONIUM SALT)
### I II 12/2/1998 FINORGA SAS TIAPRIDE HYDROCHLORIDE
### I III 11/19/1998 LEXINGTON MEDICAL DIV LEXINGTON PACKAGING MATERIALS USED IN SHORT TERM
COMPONENTS EXTERNALLY COMMUNICATING DEVICES
### I II 12/4/1998 SICOR SPA IDARUBICIN AGLYCONE (BULK CHEMICAL)
### I II 12/4/1998 SICOR SPA DAUNOSAMINE TFA ACETATE (BULK CHEMICAL)
### I II 12/3/1998 ASTELLAS IRELAND CO LTD TAMSULOSIN HYDROCHLORIDE
### I IV 12/4/1998 DERIVADOS MACROQUIMICOS SA DE CV HYDROPROPYL METHLCELLULOSE
Page 449
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 11/19/1998 PROTEIN TECHNOLOGIES PTI G-2535 (UNCONJUGATED ISOFLAVENS-70)
INTERNATIONAL INC CAPSULES 150 MG GENSTEIN
ACTIVITY/CAPSULES
### I II 11/19/1998 PROTEIN TECHNOLOGIES PTI G-4660 (UNCONJUGATED ISOFLAVENS - 100)
INTERNATIONAL INC CAPSULES 150 MG GENSTEIN
ACTIVITY/CAPSULES
### A II 11/30/1998 SOLARA A PHARMA SCIENCES LTD NAPROXEN, USP
### A II 12/3/1998 ERREGIERRE SPA MESALAMINE USP-EP
### A II 12/7/1998 TEVA PHARMACEUTICAL INDUSTRIES IDARUBICIN HYDROCHLORIDE
LTD
### A III 12/1/1998 ZEON CORP CYCLOOLEFIN POLYMER (ZEONOR 1020R)
### I III 12/7/1998 DSM RESEARCH VESTOLEN A 6016 L-O
### I II 12/7/1998 CIPLA LTD 16A-BROMOEPIANDROSTERONE
### I II 12/7/1998 SUMITOMO CHEMICAL CO LTD PAROXETINE HYDROCHLORIDE ANHYDRATE
### I II 12/7/1998 PHARMACIA AND UPJOHN SPA IODODOXORUBICIN HCL FOR INJECTION
### I II 12/8/1998 ELI LILLY AND CO DIPEPTIDYLAMINOPEPTIDASE (DDAP)
### I III 12/8/1998 AMPACET CORP 100099 UV BARRIER
### I II 12/10/1998 DIOSYNTH BV FLUVOXAMINE MALEATE
### I II 12/14/1998 BAYER PHARMA AG PYNASUNATE
### I II 12/14/1998 PENINSULA LABS INC GLU-11-VAL
### I II 12/14/1998 NV ORGANON TIBOLONE
### I II 12/15/1998 PFANSTIEHL LABORATORIES INC SODIUM DICHLOROACETATE
### I II 12/16/1998 XIAN LIBANG PHARMACEUTICAL CO LTD DROPERIDOL USP, NON-STERILE BULK DRUG
INTENDED FOR HUMAN USE
### I II 12/18/1998 DSM SINOCHEM PHARMACEUTICALS CLAVULANATE POTASSIUM MIXTURE WITH
NETHERLANDS BV SILICONE DIOXIDE IN THE RATIO 1:1
### I II 12/18/1998 DSM SINOCHEM PHARMACEUTICALS CLAVULANATE POTASSIUM MIXTURE WITH
NETHERLANDS BV MICROCRYSTALLINE CELLULOSE IN THE RATIO
1:1
### I II 12/18/1998 DSM SINOCHEM PHARMACEUTICALS CLAVULANATE POTASSIUM
NETHERLANDS BV
### I III 12/10/1998 ST GOBAIN PERFORMANCE PLASTICS 53# BLEACHED KRAFT C1S 7015 SILICONE
RELEASE COATING
### I II 12/18/1998 KYORIN PHARMACEUTICAL CO LTD GATIFLOXACIN
### I III 12/18/1998 RHODIA INDUSTRIAL YARNS AG POLYESTER GRANULAT 74K40Z108
### I II 12/17/1998 EXCELLA GMBH ENALAPRILAT
### I II 12/21/1998 HOSPIRA INC TEQUIN I.V. (GATIFLOXACIN)
### I II 12/22/1998 RESTORAGEN INC RECOMBINANT GLUCAGON-LIKE PEPTIDE-1
(RGLP)
### I II 12/17/1998 NEOMPS INC SYNTHETIC PEPTIDES MPS-74, MPS-75, MPS-76,
MPS-77, AND MPS-78
### I II 12/22/1998 SUMITOMO CHEMICAL CO LTD POTASSIUM OTASTAT
Page 450
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 12/18/1998 UBE INDUSTRIES LTD ETHYL L-CYCLOPROPY-6,7-DIFLUORO-1,4-
DIHYDRO-8-METHOXY-4-OXO-3-
QUINOLINECARBOXYLATE(6,7-DIFLUOROESTER
FORM) DRUG SUBSTANCE
### A II 12/22/1998 CORDEN PHARMA CHENOVE BISOPROLOL FUMARATE
13911 A II 12/24/1998 HERAEUS DEUTSCHLAND GMBH AND THIOTEPA USP
CO KG
### I II 12/23/1998 CHEMI SPA DSPC(1,2-DISTEAROYL-PHOPHATIDYCHOLINE)
### A II 12/23/1998 TEVA PHARMACEUTICAL INDUSTRIES FLUVOXAMINE MALEATE
LTD
### I III 12/29/1998 MARUTANI CHEMICAL PLANT HI-DRYPACK FOR PACKAGING TABLETS &
ENGINEERING CO LTD CAPLETS
### I II 1/8/1999 DEXCEL LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
OR AKIVA, ISRAEL
### I III 12/22/1998 MY HEALTHCARE ITALY SRL PRINTED ALUMINUM FOIL
### I II 12/23/1998 RECORDATI INDUSTRIA CHIMICA E LOVASTATIN
FARMACEUTICA SPA
### I III 12/23/1998 ALVEO AG ALVEOLIT TEE 0500 SKIN
### I II 12/29/1998 PLIVA DD PEMOLINE
### I II 12/24/1998 EURORESEARCH S.R.L. BISKALCITRATE LYOPHILIZED, POTASSIUM SALT
(ORAL)
### A II 12/30/1998 TARO PHARMACEUTICAL INDUSTRIES HYDROCORTISONE 17-VALERATE, USP
LTD
### I II 12/29/1998 PENINSULA LABS INC LEUPROLIDE
### I II 8/15/1998 PYRETHRUM BOARD OF KENYA PYRETHRUM
### I II 12/30/1998 ORGANICHEM CORP HYPERPOLARIZED HELIUM-3 GAS (HP-3HE)
### I II 12/18/1998 VEREIN FUR KREBSFORSCHUNG MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
ARLESHEIM, SWITZERLAND
### I II 12/21/1998 VEREIN FUR KREBSFORSCHUNG CANNADOR
### A II 12/21/1998 OLON SPA BUPROPION HYDROCHLORIDE
### I III 12/29/1998 CRYOVAC M371, OXYGEN BARRIER MEDICAL PACKAGING
MATERIAL
### A II 1/4/1999 APOTEX FERMENTATION INC CYCLOSPORINE USP (BULK)
### I III 12/28/1998 KERR SUN COAST FOOD AND LINED PLASTIC INJECTION MOLDED CLOSURE
BEVERAGE GROUP (BOTTLE CAP)
### A IV 1/4/1999 PHOSPHOLIPID GMBH PHOSAL 50 PG
### I II 1/8/1999 MALLINCKRODT INC EXENDIN-4
### I IV 1/4/1999 WILD FLAVORS INC ARTIFICIAL STRAWBERRY FLAVOR #FACN402
### I II 1/8/1999 CAMBREX PROFARMACO CORK LTD DICLOFENAC POTASSIUM
### I II 1/12/1999 TOYAMA CHEMICAL CO LTD T-3811ME DRUG SUBSTANCE
### A III 1/6/1999 BERRY GLOBAL PRODUCT 24-5-081
### A III 1/13/1999 CCC PLASTICS CANADA COLORS AND WHITE MB50-902 POLYPROPYLENE COLOUR
CHEMICALS LTD CONCENTRATE
Page 451
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 1/12/1999 RICON COLORS INC WHITE, CPP-W368-1
### I II 1/13/1999 PENINSULA LABS INC DESLORELIN
### I II 12/31/1998 AVANTI POLAR LIPIDS INC L-A-PHOSPHATIDYL-DL-GLYCEROL (EGG)
### A IV 1/15/1999 EVONIK NUTRITION AND CARE GMBH EUDRAGIT® FS 30 D
### I II 1/18/1999 BOEHRINGER INGELHEIM CHEMICALS METHADONE HYDROCHLORIDE USP
INC
### I III 1/19/1999 PRETIUM PACKAGING PACKAGING MATERIALS
### A II 1/13/1999 YANGZHOU PHARMACEUTICAL CO LTD DOXYCYCLINE MONOHYDRATE
### A II 1/15/1999 SANOFI AVENTIS DEUTSCHLAND GMBH HR1799
### I II 1/18/1999 TEVA PHARMACEUTICAL INDUSTRIES PAMIDRONATE BULK CHEMICAL
LTD
### I II 1/11/1999 LONZA LTD L-CARNITINE USP
### A II 12/29/1998 EMBIO LTD PSEUDOEPHEDRINE HYDROCHLORIDE, USP
### A V 1/13/1999 STERIS CONTRACT STERILIZATION FACILITY AT 2500
COMMERCE DRIVE LIBERTYVILLE, IL
### A II 1/19/1999 TIANJIN TIANYAO PHARMACEUTICALS PREDNISONE ACETATE USP
CO LTD
### I II 12/4/1998 CULTOR FOOD SCIENCE INC MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
KOTKA, FINLAND
### I II 12/4/1998 CULTOR FOOD SCIENCE INC LACTITOL MONOHYDRATE
### I III 1/20/1999 AMPACET CORP 19699 BLACK POLYETHYLENE
### I III 1/20/1999 LUBRIZOL ADVANCED MATERIALS INC STAT-RITE E-1150-001
### A II 1/21/1999 ANALYTECON SA PODOPHYLLOTOXIN (CPH-86)
### I II 1/22/1999 3M PHARMACEUTICALS R-848 DRUG SUBSTANCE AND DRUG PRODUCT
(ORAL)
### I II 1/22/1999 ALKERMES INC FLUVOXAMINE MALEATE CR CAPSULES
### A III 1/18/1999 TECHMER PM PACKAGING MATERIALS
### A II 1/26/1999 TEVA PHARMACEUTICAL INDUSTRIES TERAZOSIN HCI DIHYDRATE
LTD
### A II 1/25/1999 PQ CORP MAGNESIUM SULFATE HEPTAHYDRATE, USP
(PARENTERAL GRADES)
### I II 1/29/1999 GLAXOSMITHKLINE LLC MUPIROCIN FREE ACID AND MUPIROCIN
CALCIUM (NON-STERILE)
### I II 1/29/1999 TEVA PHARMACEUTICAL INDUSTRIES ESTROGENIC POWDERS
LTD
### A II 1/29/1999 BIOTIKA AS PENICILLIN V POTASSIUM
### I III 1/29/1999 AMPACET CORP 100552-A AS POLYETHYLENE MASTERBATCH
### I II 1/29/1999 TEVA PHARMACEUTICAL INDUSTRIES BECLOMETHASONE DIPROPIONATE
LTD MONOHYDRATE
### A II 1/29/1999 ENTERIS BIOPHARMA INC AMIDATING ENZYME
### I II 1/22/1999 SIMAFEX SAS DOTA
### I III 2/3/1999 FINA RESEARCH SA FINATHENE 6006
### A IV 1/29/1999 ASHLAND LLC PLASDONE S-630
Page 452
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 12/4/1998 CULTOR FOOD SCIENCE INC LACTITOL, DIRECTLY COMPRESSIBLE FORM,
(FINLAC DC)
### A II 2/4/1999 ASPEN OSS BV GANIRELIX,
### I II 2/9/1999 PRODUCTOS QUIMICOS NATURALES SA EQUILIN, USP
DE CV
### I III 2/3/1999 AMPACET CORP 110021 WHITE PE MB POLYETHYLENE
MASTERBATCH
### I II 2/8/1999 MEDI CULT AS MANUFACTURING SITE, FACILTIES, PERSONNEL
AND OPERATING PROCEDURES IN
COPENHAGEN, DENMARK
### I II 2/8/1999 MEDI CULT AS RENCYTE SYSTEM
### I II 2/9/1999 UNIV MICHIGAN MEDCTR NGVL/NONVIRAL GMP VECTOR PRODUCTION
FACILITY IN ANN ARBOR, MI
### I II 2/16/1999 PRODUCTOS QUIMICOS NATURALES SA DEHYDROESTRONE
DE CV PROQUINA
### I III 1/28/1999 SOLVAY POLYOLEFINS EUROPE SA ELTEX A5006FN1285
### I II 2/17/1999 MITSUBISHI TANABE PHARMA CORP MCC-555
### I II 2/10/1999 KUNMING INSTITUTE OF BOTANY PACLITAXEL (TAXOL)
### I III 1/21/1999 SOLVIN SA IXAN PVDC PA 345
### I III 1/21/1999 SOLVAY SA IXAN PVDC PA 910
### A II 2/9/1999 INDUSTRIALE CHIMICA SRL PENTAZOCINE HYDROCHLORIDE
### I II 2/19/1999 KOPALLE PHARMA CHEMICALS PVT LTD MANUFACTURING SITE, FACILITIES,
PERSONNEL AND OPERATING PROCEDURES IN
HYDERABAD, INDIA
### A II 2/17/1999 LABORATOIRES BESINS INTERNATIONAL ESTROGEL 0.06%
Page 454
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 3/11/1999 PHARMACIA AND UPJOHN SPA MANUFACTURING SITE FACILITIES OPERATING
PROCEDURES AND PERSONNEL OF THE GS/API
PROCESS R&D PLANT IN NERVIANO ITALY
Page 455
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 3/7/1999 RISDON SA THERMOPLASTICS FOR THE MANUFACTURE OF
EYE DROPPERS AND ACCESSORIES
### A II 3/19/1999 WANBURY LTD METFORMIN HYDROCHLORIDE
### A II 4/5/1999 VUAB PHARMA AS NYSTATIN USP
### I III 3/24/1999 INGENIA POLYMERS CORP WT170 WHITE FOR USE IN PACKAGING
MATERIALS
### I II 4/7/1999 SUN PHARMACEUTICAL INDUSTRIES CEFUROXIME AXETIL USP (CRYSTALLINE)
LTD
### I II 4/5/1999 ERREGIERRE SPA OXAPROZIN JP
### I III 3/30/1999 CANADA COLORS AND CHEMICALS LTD WHITE MB20922 POLYETHYLENE COLOR
CONCENTRATE
### I III 4/27/1999 WADDINGTON IP JAYCARE DESIGNS MATERIALS AND SPECIFICATIONS FOR
60ML WHITE OPAQUE HDPE BOTTLE
### I II 4/12/1999 ML LABORATORIES DEXTRIN SULPHATE
### I II 4/9/1999 UBE INDUSTRIES LTD 6,7-DIFLUOROACID FORM INTERMEDIATE
### A III 4/12/1999 MEDISIZE IRELAND LTD SADDLE PORT SYSTEM DESIGNED FOR USE IN
MEDICAL FLUID CONTAINERS
### I II 4/7/1999 DEPA ILAC AKTIF MADDELERI SANAYI VE CLAVULANATE POTASSIUM
PAZARLAMA AS
### I II 4/9/1999 SPECIALTIES SEPTODONT MANUFACTURING SITE, FACILITIES, OPERATING
PROCEDURES, AND PERSONNEL AT
SPECIALITIES SEPTODONT LOCATED IN SAINT
MAURDES FOSSES, FRANCE
### A III 4/8/1999 3M DRUG DELIVERY SYSTEMS 3M COTRAN 9728 18.5% EVA FILM
### I III 4/8/1999 3M DRUG DELIVERY SYSTEMS DIV COTRAN 9726 (2% ETHYLENE VINYL ACETATE
(EVA) FILM)
### A III 4/8/1999 3M DRUG DELIVERY SYSTEMS 3M COTRAN™ 9702 9% EVA FILM
### I II 4/7/1999 SAFC BIOSCIENCES INC EX-CELL PF CHO
### I II 3/30/1999 JUZEN CHEMICAL CORP OXYBUTYNIN
### A II 4/7/1999 BAXTER HEALTHCARE CORP ICODEXTRIN POWDER
### I II 4/7/1999 ML LABORATORIES PHASE V OUTCOMES INFORMATION SYSTEM
LOCATED IN WELLESLEY HILLS MA
### I II 4/7/1999 RANBAXY LABORATORIES LTD CEFUROXIME AXETIL
### I II 3/22/1999 WL GORE AND ASSOC INC GORE PERISTALTIC PUMP TUBING
### I I 3/23/1999 STERITEK INC MANUFACTURING SITE, FACILITIES, OPERATING
PROCEDURES, MAJOR EQUIPMENT, AND KEY
PERSONNEL FOR PACKAGING OF DRUG
PRODUCTS IN MOONACHIE, NEW JERSEY.
### A II 3/29/1999 GEDEON RICHTER PLC SPIRONOLACTONE USP
### I II 4/8/1999 SICOR DE MEXICO SA DE CV CYPROTERONE ACETATE
### I II 4/15/1999 PLIVA DD MANUFACTURING SITE, PERSONNEL, AND
OPERATING PROCEDURES FOR AZITHROMYCIN
DIHYDRATE
### I II 4/9/1999 CLARIANT GMBH GRIESHEIM WORKS N-CARBOXYBENZYL-3-FLUORO-4-
DIVISION FINE CHEMICALS MORPHOLINOANILINE
Page 456
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 4/23/1999 ALGROUP LAWSON MARDON LAMINATED ALUMINUM FOIL PACKAGES AS
PRODUCED IN TORONTO, ONTARIO, CANADA
### A III 4/23/1999 BERRY GLOBAL BPN6036
### I III 4/21/1999 AMPACET CORP 11989-I WHITE PE POLYETHYLENE
MASTERBATCH
### A III 4/19/1999 ZEON CORP CYCLOOLEFIN POLYMER (ZEONEX 690 R)
### A III 4/12/1999 EXAL CORP PACKAGING MATERIALS AEROSOL ALUMINUM
CONTAINER
### A II 4/19/1999 CATALENT PHARMA SOLUTIONS LLC TARGRETIN 75 MG SOFT-GELATIN CAPSULE
### A II 4/17/1999 IPCA LABORATORIES LTD HYDROXYCHLOROQUINE SULFATE USP
### I II 4/19/1999 CLARIANT GMBH N-CARBOXYBENZYL-3-FLUORO-4-
MORPHOLINOANILINE
### I II 4/20/1999 LONZA BIOTEC SRO LEVOCARNITINE TARTATE
### I III 4/21/1999 HUMPHREY COSBURN PLASTICS PLASTIC APPLICATORS
### A II 4/22/1999 ALBEMARLE CORP 1LZD-LINEZOLID, STEP 1
### I III 4/6/1999 INTERGLASS INC TUBING GLASS CONTAINERS (AMPOULES &
VIALS)
### A II 4/16/1999 DISHMAN NETHERLANDS BV CALCITRIOL
### I II 4/23/1999 CHEMI SPA 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-
PHOSPHOGLYCEROL AMMONIUM SALT
### A III 3/1/1999 CANADA COLORS AND CHEMICALS LTD ANTIBLOCK MB-551-13 POLYPROPYLENE
ADDITIVE CONCENTRATE
### I II 4/30/1999 SAFC BIOSCIENCES INC EX-CELL 525 FOR PER C6 CELLS, DEFINED
SERUM FREE MEDIUM
### I II 5/3/1999 AJINOMOTO CO INC AT-1015 A 5-HT2A ANTAGONIST
### I III 5/4/1999 WISTOFF GMBH AND CO PHARMACEUTICAL GLASS CONTAINERS
### A II 5/3/1999 MEDICHEM SA FELODIPINE
### I II 4/28/1999 YAMASA CORP DIQUAFOSOL TETRASODIUM
### I II 4/30/1999 EURO CHEMI INC NIZATIDINE
### I III 4/26/1999 DOW CHEMICAL CO POLYETHYLENE RESINS FOR PACKAGING AND
MEDICAL APPLICATIONS
### A II 4/29/1999 H LUNDBECK AS ESCITALOPRAM OXALATE
### I III 4/24/1999 CLARIANT MASTERBATCHES ITALIA SPA CUSTOM COLORING/ADDITIVE CONCENTRATES
FOR USE IN PLASTIC PRODUCTS AND
PACKAGING
### I III 5/3/1999 HUNTSMAN POLYPROPYLENE CORP POLYPROPYLENE PRODUCTS
### A III 4/19/1999 GERRESHEIMER GLASS INC MOULDED GLASS PACKAGING MATERIAL AND
CONTAINERS
### I III 2/23/1999 PECHINEY EMBALLAGE FLEXIBLE FOIL FOR PHARMACEUTICAL WHITE(ONE SIDE)
EUROPE BLISTERFOIL
### I III 2/23/1999 PECHINEY EMBALLAGE FLEXIBLE FOIL FOR PHARMACEUTICAL WHITE(BOTH
EUROPE SIDES) BLISTERFOIL WITH PHTALATES
### A II 5/10/1999 EUTICALS SPA 1-LZD
14110 A III 5/10/1999 WEST PHARMACEUTICAL SERVICES INC ELASTOMER COMPARABILITY: FORMULATIONS
4588/40 GRAY AND 1888 GRAY
Page 457
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
14111 I IV 3/16/1999 FONA INTERNATIONAL INC 825.075 ARTIFICIAL WILD CHERRY FLAVOR
14112 I IV 3/25/1999 FONA INTERNATIONAL INC 936.115 NATURAL BITTERING FLAVOR
14113 I IV 3/25/1999 FONA INTERNATIONAL INC EU 936.115 NATURAL BITTERING FLAVOR
14114 I IV 3/25/1999 FONA INTERNATIONAL INC 942.001 N-C NATURAL & ARTIFICIAL DAIRY
FLAVOR
14115 I IV 3/16/1999 FONA INTERNATIONAL INC 915.356 ARTIFICIAL STRAWBERRY FLAVOR
(FRESH )
14116 I IV 3/16/1999 FONA INTERNATIONAL INC 918.004 SWEET AM (A NATURAL FLAVOR)
14117 I IV 3/23/1999 FONA INTERNATIONAL INC 815.105 BUBBLEMINT FLAVOR (NATURAL AND
ARTIFICIAL)
14118 I IV 3/15/1999 FONA INTERNATIONAL INC 827.183 N-C CINNAMON FLAVOR NATURAL AND
ARTIFICIAL
14119 I IV 3/15/1999 FONA INTERNATIONAL INC 827.182 N-C CINNAMON FLAVOR NATURAL AND
ARTIFICIAL
### I III 5/7/1999 AMPACET CORP 11134 WHITE PE MB POLYETHYLENE
MASTERBATCH
### A III 5/7/1999 AMPACET CORP 190405 BLACK PE MB POLYETHYLENE
MASTERBATCH
### I III 5/7/1999 AMPACET CORP 10561 UV PE MB POLYETHYLENE
MASTERBATCH
### I III 5/7/1999 AMPACET CORP 19909-T BLACK PE MB POLYETHYLENE
MASTERBATCH
### I III 5/7/1999 AMPACET CORP 190007-U BLACK PE MB POLYETHYLENE
MASTERBATCH
### I III 5/7/1999 AMPACET CORP 11303 WHITE UV PE MB POLYETHYLENE
MASTERBATCH
### I III 5/7/1999 AMPACET CORP 10478-A UV PE MB POLYETHYLENE
MASTERBATCH
### I III 5/7/1999 AMPACET CORP 19909 BLACK PE MB POLYETHYLENE
MASTERBATCH
### I III 5/7/1999 AMPACET CORP 11376 WHITE HDPE MB POLYETHYLENE
MASTERBATCH
### A II 5/5/1999 PERKINELMER INC YTTRIUM-90
### I I 4/30/1999 PUBLIC STOCK CORPORATION OYJ DESCRIPTION OF FACILITIES PROCESS AND
MATERIALS OF G PLANT LOCATED IN
NURMIJARU FINLAND
### I IV 5/7/1999 FONA INTERNATIONAL INC 825.450 CHERRY MINT ARTIFICIAL FLAVOR
### I II 5/1/1999 ALPS PHARMACEUTICAL IND CO LTD SENNOSIDES(60)
### A II 5/3/1999 SANDOZ GMBH CEFAZOLIN SODIUM (STERILE)
### I III 5/6/1999 AMPACET CORP 110532-I WHITE POLYETHYLENE MASTERBATCH
Page 460
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 6/7/1999 HUNTSMAN POLYPROPYLENE CORP POLYPROPYLENES PP23M2 23M2CS38
23M2CS198 23M2CS219 23M2CS260 23M10
23M10CS259 41E4CS215 AND 31S4CS62
### A II 6/11/1999 EUTICALS SPA DISOPYRAMIDE PHOSPHATE
### I II 6/15/1999 SANKYO CO LTD CS-780 DRUG PRODUCT
### I III 6/8/1999 WINPAK TECHNOLOGIES INC FLEXIBLE PACKAGING MATERIALS FOR
VARIOUS PHARMACEUTICAL APPLICATIONS
### I II 5/20/1999 KYOWA HAKKO KOGYO CO LTD UBIDECARENONE BULK
### A II 6/14/1999 AMRI RENSSELAER INC PRALIDOXIME CHLORIDE USP
### A II 6/17/1999 UNION QUIMICO FARMACEUTICA SA KETOROLAC TROMETHAMINE USP
(UQUIFA SA)
### A II 6/14/1999 CADILA HEALTHCARE LTD ATENOLOL USP
14211 I II 4/22/1997 YUHAN CORP CEFACLOR BULK
### I II 9/1/1980 GLAXO PHARMACEUTICALS LTD AMPICILLIN TRIHYDRATE
### I II 4/5/1990 BRISTOL MYERS SQUIBB CO HETACILLIN POTASSIUM
### I III 3/24/1999 AMPACET CORP 16180 BLUE PE MB POLYETHYLENE
MASTERBATCH
### A III 6/16/1999 AMPACET CORP 7188335 WHITE POLYETHYLENE MASTERBATCH
### I III 6/21/1999 AKERLUND AND RAUSING GROUP TRANSOFOIL LL-OPET/PE LAMINATE
### I III 6/15/1999 POLYVEL INC ANTISTATIC ADDITIVE CONCENTRATE USED IN
THE G OF FLEXIBLE CONTAINMENT DEVICES
### I III 6/15/1999 POLYVEL INC ANTIBLOCK ADDITIVE CONCENTRATE USED IN
THE G OF FLEXIBLE CONTAINMENT DEVICES
### I II 6/18/1999 NINGXIA PHARMACEUTICAL FACTORY MANUFACTURING SITES FACILITIES OPERATION
PROCEDURES AND PERSONNEL IN YINCHUAN
CITY NINGXIA HUI NATIONALITY
### A II 6/23/1999 SHANGHAI ZHONGXI SUNVE SULFAMETHAZINE SODIUM
PHARMACEUTICAL CO LTD
### I III 6/21/1999 AMPACET CORP 13920 YELLOW PE MB POLYETHYLENE
MASTERBATCH
### A II 6/22/1999 EXCELLA GMBH AND CO KG HALOPERIDOL
### I IV 6/2/1999 FONA INTERNATIONAL INC 915.354 N-C ARTIFICIAL STRAWBERRY FLAVOR
### I IV 6/2/1999 FONA INTERNATIONAL INC 831.002 N-C ARTIFICIAL PINA COLADA FLAVOR
### I IV 6/18/1999 FONA INTERNATIONAL INC 825.476 ARTIFICIAL CHERRY FLAVOR
### I IV 6/18/1999 FONA INTERNATIONAL INC 826.229 NATURAL AND ARTIFICIAL CHOCOLATE
FLAVOR
Page 461
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 6/18/1999 BERRY PLASTICS CORP PRODUCT 24-5-067
### I III 6/18/1999 BERRY PLASTICS CORP TAPES AND STERILE FINISHED PRODUCTS AND STERILE
COATINGS DIV PROCESSING OPERATIONS
### I III 6/18/1999 BERRY PLASTICS CORP TAPES AND ASEPTIC PROCESSING FACILITY FOR
COATINGS DIV ROMMELAG(R) BOTTELPACK(R) BLOW-FILL-
SEAL TECHNOLOGY IN SULZBACH AND
UNTERGRONINGEN, GERMANY
### A II 6/24/1999 CHUNGHWA CHEMICAL SYNTHESIS AND GUAIFENESIN USP
BIOTECH CO LTD
### A II 6/24/1999 CHUNGHWA CHEMICAL SYNTHESIS AND PRAVASTATIN SODIUM USP
BIOTECH CO LTD
### A II 6/7/1999 ROHNER LTD 4-AMINO-5-CHLORO2,1,3-BENZOTHIADIAZOLE
(CABTD)
### I II 6/24/1999 SIFAVITOR SRL ECONAZOLE
### I II 6/28/1999 ASUBIO PHARMA CO LTD CARPERITIDE DRUG SUBSTANCE
### I II 6/25/1999 PHARMASYNTHESE PHARMACEUTICAL BRAND PROTECTION AND
ANTI-COUNTERFEITING INSTRUMENTATION AND
PROCESS FOR HARD CAPSULES
### I II 6/25/1999 SUN PHARMACEUTICAL INDUSTRIES OFLOXACIN USP
LTD
### A II 6/25/1999 TEVA PHARMACEUTICAL INDUSTRIES NORGESTIMATE BULK DRUG SUBSTANCE
LTD
### I II 6/29/1999 MITSUBISHI TANABE PHARMA CORP MKC-242 BULK DRUG SUBSTANCE
### I II 7/1/1999 COMPANHIA INDUSTRIAL PRODUTORA TETRACYCLINE PHOSPHATE
DE ANTIBIOTICOS SARL
### A II 7/1/1999 COMPANHIA INDUSTRIAL PRODUTORA DEMECLOCYCLINE HCL
DE ANTIBIOTICOS SA
### I II 7/1/1999 COMPANHIA INDUSTRIAL PRODUTORA ERYTHROMYCIN STEARATE
DE ANTIBIOTICOS SARL
### I II 7/6/1999 LEO LABORATORIES LTD AMDINOCILLIN PIVOXIL HCL
### I II 5/25/1999 MEDIBRANDS LTD G SITE FACILITIES OPERATING PROCEDURES
AND PERSONEL FOR MEDIBRANDS LTD. IN
HAIFA ISRAEL
### I II 6/14/1999 SAFC BIOSCIENCES INC EX-CELL PF CHO MEDIUM(MODIFIED)
### I II 5/26/1999 ECOLAB INC 20% CHLORHEXIDINE GLUCONATE
### I III 6/23/1999 ASTRA PLASTIQUE CONTAINER CLOSURES(CAPS)
### I II 6/30/1999 PHIBRO ANIMAL HEALTH CORP POTASSIUM NITRATE USP
### A II 6/29/1999 CADILA PHARMACEUTICALS LTD FLUOXETINE HYDROCHLORIDE USP
### A III 6/30/1999 ISHIDA PRESS KOGYO CO LTD ALUMINUM CAPS FOR MEDICAL VIALS
### A II 5/25/1999 CARLSON FILTRATION LTD ASBESTOS FREE DEPTH FILTER SHEETS
### I II 6/29/1999 RHODIA INDUSTRIE CHIMIQUE LEVOTHYROXINE SODIUM USP
MULHOUSE DORNACH
### I II 6/28/1999 HOSPIRA INC ROGOSIN EMULSION
### A II 6/25/1999 BOEHRINGER INGELHEIM PHARMA ALBUTEROL SULFATE (UNMICRONIZED)
GMBH AND CO KG
Page 462
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 6/25/1999 BOEHRINGER INGELHEIM PHARMA IPRATROPIUM BROMIDE MONOHYDRATE
GMBH AND CO KG
### I II 7/3/1995 BIOCHIMICA OPOS SPA CLINDAMYCIN HYDROCHLORIDE
### I III 6/30/1999 ZIMMER CUSTOM-MADE PACKAGING MOBIL OPPALYTE 35MU842/COMMEX CX1102
FILM LAMINATE
### A III 6/25/1999 LAGEEN TUBOPLAST LTD PLASTIC TUBES AND CAPS
### I III 6/29/1999 MEDIFIQ HEALTHCARE CORP JADELLE (R) INSERTER SET
### I II 6/29/1999 CADILA PHARMACEUTICALS LTD G SITE FACILITIES PROCEDURES AND
PERSONEL FOR ANKLESHWAR SITE IN GUJARAT
INDIA
### I III 6/30/1999 TRANSFOBEL PLASTICS NV POLYPROPYLENE SCREWCAPS FOR LOCKING
ALUMINUM TUBES
### I II 6/29/1999 JK DRUGS AND PHARMACEUTICALS LTD CEPHALEXIN USP
Page 467
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 9/30/1999 INSTITUTE DRUG TECHNOLOGY TIAZOFURIN
AUSTRALIA LTD
### I I 9/3/1999 NORDEN PAC PLASTIC AB G SITE FACILITIES OPERATING PROCEDURES
AND PERSONNEL FOR ASTORP SWEDEN
LOCATION
### I II 10/21/1999 DUMEX ALPHARMA AS COLISTIN SULFATE MONOCOMPONENT
### I II 9/29/1999 JANSSEN PHARMACEUTICA NV GALANTAMINE HYDROBROMIDE
### A II 9/30/1999 UGP THERAPEUTICS INC CALCITONIN-SALMON (RDNA ORIGIN)
### I III 10/1/1999 B BRAUN MELSUNGEN AG 1 ML DISPENSER SET / 93 MM 4 ML DISPENSER-
SET / 93 MM 4ML DISPENSER SET "DO NOT
RINSE" / 93 MM 4 ML DISPENSER-SET "6 MG
EXELON"® SUCTION TUBE 120 MM (FOR
DISPENSER-SET 6 MG EXELON®)
### A II 9/30/1999 DR REDDYS LABORATORIES LTD OXAPROZIN USP
### A II 9/28/1999 CORDEN PHARMA SWITZERLAND LLC 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-
PHOSPHOGLYCEROL SODIUM SALT (POPG NA)
### I II 9/28/1999 BOEHRINGER INGELHEIM PHARMA MELOXICAM JETMILLED
GMBH AND CO KG
### I II 9/30/1999 ASAHI GLASS CO LTD PAROXETINE HYDROCHLORIDE AMORPHOUS
### I III 9/30/1999 MULTIFILM PACKAGING CORP CAST POLYPROPYLENE TWISTWRAP
### I III 9/27/1999 AMPACET CORP 110916 WHITE POLYETHYLENE MASTERBATCH
### I III 9/27/1999 AMPACET CORP 110869 WHITE COP CMPD POLYETHYLENE
MASTERBATCH
### A II 10/5/1999 FERMIC SA DE CV CLAVULANATE POTASSIUM
### A II 10/5/1999 CIPLA LTD SERTRALINE HYDROCHLORIDE USP (FORM-V)
### A II 10/4/1999 CHATTEM CHEMICALS INC BUTABARBITAL SODIUM
### I II 6/23/1999 SANYO FINE CO LTD ELS(ELASTASE)
### I II 10/8/1999 GENZYME CORP LEUPROLIDE ACETATE
### I II 10/7/1999 PFANSTIEHL LABORATORIES INC N-ACETYL-D-GLUCOSAMINE
### I II 10/7/1999 SLOVAKOFARMA AS MEXILETINE HYDROCHLORIDE
### A IV 10/8/1999 PADDOCK LABORATORIES LLC ORA-BRAND OF ORAL PHARMACEUTICAL
VEHICLES
### I IV 10/12/1999 FONA INTERNATIONAL INC 826.397 N-C CHOCOLATE FLAVOR NATURAL AND
ARTIFICIAL
### I IV 10/12/1999 FONA INTERNATIONAL INC 840.136 ART CREAM FLAVOR POWDER
### I IV 10/12/1999 FONA INTERNATIONAL INC 852.263 N-C NAT AND ART GOLDEN PUNCH
FLAVOR
### I IV 10/12/1999 FONA INTERNATIONAL INC 884.044 NAT ORANGE EXTRACT
### I IV 10/12/1999 FONA INTERNATIONAL INC 800.002 N-C NAT ALMOND FLAVOR
### I IV 9/21/1999 FONA INTERNATIONAL INC 926.462 NAT AND ART VANILLA FLAVOR
### I IV 9/21/1999 FONA INTERNATIONAL INC 906.243 N-C NAT RASPBERRY FLAVOR WONF
### I IV 9/21/1999 FONA INTERNATIONAL INC 895.047 NAT ART PINEAPPLE FLAVOR
### I IV 9/21/1999 FONA INTERNATIONAL INC 884.612 JUICY ORANGE FLAVOR NAT AND ART
### I IV 9/21/1999 FONA INTERNATIONAL INC 884.611 JUICY ORANGE FLAVOR NAT AND ART
Page 468
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I IV 9/21/1999 FONA INTERNATIONAL INC 884.610 ORANGE CREME FLAVOR EMULSION
NAT AND ART
### I IV 9/21/1999 FONA INTERNATIONAL INC 884.011 ORANGE CREME FLAVOR NAT AND ART
FLAVOR
### I IV 9/21/1999 FONA INTERNATIONAL INC 861.057 N-C NATURAL LEMON HONEY
FLAVOR(WONF)
### I IV 9/21/1999 FONA INTERNATIONAL INC 856.055 N-C NATURAL GRAPE FLAVOR(WONF)
### I IV 9/21/1999 FONA INTERNATIONAL INC 856.012 N-C NATURAL GRAPE FLAVOR
### I IV 9/12/1999 FONA INTERNATIONAL INC 856.003 NC ART GRAPE FLAVOR
### I IV 9/21/1999 FONA INTERNATIONAL INC 852.330 RED PUNCH FLAVOR NAT AND
ART(ALCOHOL FREE)
### I IV 9/21/1999 FONA INTERNATIONAL INC 839.099 N-C CRANBERRY FLAVOR NAT(WONF)
### I IV 9/21/1999 FONA INTERNATIONAL INC 825.527 CHERRY FLAVOR NAT AND
ART(ALCOHOL FREE) ETOH
### I IV 10/6/1999 FONA INTERNATIONAL INC 915.192 ART STRAWBERRY FLAVOR
### I IV 10/7/1999 FLAVORS NORTH AMERICA INC 890.045 OS NATURAL MOCHA FLAVOR
### I IV 10/7/1999 FONA INTERNATIONAL INC 944.023 OS ART KIWI FLAVOR
### A III 10/1/1999 POLYONE CORP CC10004850WE
### A II 9/29/1999 3M PURIFICATION INC BETAPURE NT-P SERIES CARTRIDGE
PRODUCTS
### A II 10/6/1999 SOLARA A PHARMA SCIENCES LTD RANITIDINE HYDROCHLORIDE
### A II 10/11/1999 LONZA BIOLOGICS PLC HP67.6 ANTIBODY
### I II 10/14/1999 RANBAXY LABORATORIES LTD LOVASTATIN USP
### I II 10/8/1999 SICOR SPA N-ACETYL CALICHEAMICIN
### A II 10/8/1999 TEVA PHARMACEUTICAL INDUSTRIES NAC-GAMMA CALICHEAMICIN ACBUT
LTD OSU(PIVOTAL INTERMEDIATE)
### I III 10/13/1999 POLIMERI EUROPA SPA RIBLENE FM53
### A II 10/19/1999 UQUIFA MEXICO SA DE CV CIPROFLAXIN HCL
### I II 10/13/1999 GLAXOSMITHKLINE PAROXETINE HYDROCHLORIDE HEMIHYDRATE
### A III 10/8/1999 SOCIETA INDUSTRIA COMMERCIO PACKAGING MATERIAL RELATED TO THE
APPLICAZIONI TECNICHE E PRODUCTION OF GLASS AMPOULES
FARMACEUTICHE SPA
### A II 10/15/1999 OLON SPA MYCOPHENOLIC ACID NS TECHNICAL GRADE
### I III 10/18/1999 DONEGAL HEALTHCARE LTD TIP & CAP DROPPER SYSTEM
### I II 10/20/1999 BOSTON BIOSYSTEMS GTI-2040 DRUG SUBSTANCE
### I II 10/14/1999 WOCKHARDT LTD AZITHROMYCIN USP
### I IV 10/18/1999 FONA INTERNATIONAL INC 807.117 N-C MIXED BERRY FLAVOR NAT(WONF)
### I IV 10/15/1999 FONA INTERNATIONAL INC 815.111 BUBBLEMINT FLAVOR NAT & ART
### I IV 10/15/1999 FONA INTERNATIONAL INC 815.112 BUBBLEMINT FLAVOR NAT & ART
### I IV 10/18/1999 FONA INTERNATIONAL INC 856.409 GRAPE FLAVOR ART
### I IV 10/18/1999 FONA INTERNATIONAL INC 926.336 N-C NAT & ART VANILLA FLAVOR
### I IV 10/18/1999 FONA INTERNATIONAL INC 932.049 WINTERGREEN FLAVOR ART
### I IV 10/18/1999 FONA INTERNATIONAL INC 932.050 WINTERGREEN FLAVOR ART
### I IV 10/18/1999 FONA INTERNATIONAL INC 932.051 WINTERGREEN FLAVOR ART
### I IV 10/18/1999 FONA INTERNATIONAL INC 936.404 MASKING AGENT FLAVOR NAT
Page 469
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 10/10/1999 ZSCHIMMER AND SCHWARZ ITALIANA GM 9011/C
SPA
### A IV 10/10/1999 ZSCHIMMER AND SCHWARZ ITALIANA ZETESOL LES 2
SPA
### I II 10/14/1999 RP SCHERER NORTH AMERICA ACCUTANE (ISOTRETINOIN)
### I II 10/5/1999 JK DRUGS AND PHARMACEUTICALS LTD 7-AMINODESACETOXYCEPHALOSPORANIC ACID
(7-ADCA) CHEMICAL INTERMEDIATE
### I II 10/11/1999 MEITO SANGYO CO LTD G AND QUALITY CONTROL OF SUBSTANCES-
NAGOYA-AS IN AICHI JAPAN
### I III 10/22/1999 KANEKA TEXAS CORP PA-10 PA-20 PA-30 PA-40 PA-50 PA-101 AND PA-
110
### I III 10/20/1999 BOREALIS AG HE1903
### A III 10/18/1999 LAJOVIC TUBA EMBALAZA DD ALUMINUM TUBES FOR USE IN THE
PHARMACEUTICAL INDUSTRY
### I II 10/21/1999 EVERLIGHT CHEMICAL INDUSTRIAL G SITE FACILITIES OPERATING PROCEDURES
CORP AND PERSONEL FOR FACTORY LOCATED IN
TAOYUAN HSIEN TAIWAN
### I II 10/21/1999 EVERLIGHT CHEMICAL INDUSTRIAL MISOPROSTOL
CORP
### I II 10/28/1999 HOECHST MARION ROUSSEL MP52
PHARMACEUTICALS INC
### A II 10/29/1999 SPECGX LLC OXYMORPHONE HYDROCHLORIDE USP
### I II 10/27/1999 BIOXEL PHARMA INC PACLITAXEL
### A II 10/22/1999 GADOR SA PAMIDRONIC ACID A PHARMACEUTICAL
INGREDIENT
### A II 10/27/1999 SPECGX LLC SUFENTANIL CITRATE USP
### I III 9/29/1999 AGIFIN SRL SECURECLIK 5ML SAFETY SYRINGES WITH
RETRACTABLE NEEDLE
### I II 11/9/1999 QUIMICA FINA FARMEX SA DE CV ITRACONAZOLE
### I IV 11/1/1999 FONA INTERNATIONAL INC 802.029 N-C ANISE FLAVOR NATURAL
### I I 11/5/1999 LA CALHENE G SITE FACILITIES OPERATING PROCEDURES
AND PERSONEL FOR PHARMACEUTICAL
PACKAGE COMPONENT PROCESSING FACILITY
LOCATED IN VENDOME FRANCE
### I III 10/27/1999 PRESSPART INC EXTRUDED CANS
14511 A II 10/29/1999 MEDICHEM SA FLUVOXAMINE MALEATE
### I II 10/26/1999 TEVA PHARMACEUTICAL INDUSTRIES THIOTEPA
LTD
### I III 10/27/1999 AMPACET CORP 11976 WHITE PE POLYETHYLENE
MASTERBATCH
### I II 11/5/1999 PRONOVA BIOMEDICAL AS G SITE FACILITIES OPERATING PROCEDURES
AND PERSONEL FOR OSLO NORWAY
### A IV 11/5/1999 DUPONT NUTRITION USA INC CHITOSAN CHLORIDE AND CHITOSAN
GLUTAMATE
### A III 10/1/1999 POLYONE CORP CC00017246WE/D4
Page 470
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 11/22/1999 ARDAGH GLASS GMBH AMBER GLASS CONTAINERS
### I III 11/8/1999 DSM RESEARCH STAMYLAN P 15M10
### I III 11/8/1999 DSM RESEARCH STAMYLAN P 16M10
### I II 10/15/1999 DAICEL CHEMICAL INDUSTRIES LTD FACILITIES PERSONEL AND GENERAL
OPERATING PROCEDURES OF ARAI PLANT FOR
G OF CHIRAL PAK ADCSP FOR LIQUID
CHROMATIC RESOLUTION IN NIIGATA JAPAN
### I II 10/15/1999 DAICEL CHEMICAL INDUSTRIES LTD CHIRALPAK AD CSP
### I III 8/13/1999 POLIMERI EUROPA FRANCE FLEXIRENE MR50
### I III 10/15/1999 RISDON SA CONTRACT STERILIZATION FACILITY IN
HAYWARD, CA
### A II 11/15/1999 LG CHEM LTD GEMIFLOXACIN MESYLATE
### I II 11/12/1999 SAFC BIOSCIENCES INC EX-CELL 325 PF CHO PROTEIN FREE MEDIUM
### I III 11/10/1999 CANADA COLORS AND CHEMICALS LTD PACKAGING MATERIAL
### I II 11/9/1999 CHEMI SPA POPC(1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-
PHOSPHORYLCHOLINE)
### I II 11/10/1999 JK DRUGS AND PHARMACEUTICALS LTD CEPHRADINE USP
### A II 11/12/1999 APOTEX PHARMACHEM INDIA PVT LTD FLUVOXAMINE MALEATE USP
### I II 11/16/1999 WOCKHARDT LTD FAMOTIDINE USP
### I III 11/15/1999 BORMIOLI ROCCO E FIGLIO SPA SPECIAL CHILD PROOF CAP 028MM
PLASTIC DIV
### I II 11/15/1999 PHARMACEUTICAL FINE CHEMICALS TERAZOSIN HYDROCHLORIDE
PFC BAHAMAS LTD
### I III 11/15/1999 HI TECH POLYMERS INDIA PVT LTD HDPE BOTTLES AND CLOSURES FOR
PHARMACEUTICAL APPLICATIONS
### A II 11/11/1999 DIPHARMA FRANCIS SRL BUPROPION HCL
### I III 11/11/1999 COLORS FOR PLASTICS INC R28415
### I II 11/16/1999 EVONIK CORP LISINOPRIL CRUDE
### I II 11/19/1999 FUJISAWA PHARMACEUTICAL CO LTD FK8453 DRUG SUBSTANCE
### A II 11/9/1999 TEVA PHARMACEUTICAL INDUSTRIES AMCINONIDE
LTD
### A II 11/18/1999 UNION QUIMICO FARMACEUTICA SA CLINDAMYCIN HYDROCHLORIDE USP
(UQUIFA SA)
### A II 11/18/1999 ASPEN OSS BV TESTOSTERONE UNDECANOATE
### I II 11/22/1999 EVONIK TECHNOCHEMIE GMBH TRAMADOL HYDROCHLORIDE
### I IV 11/14/1999 FONA INTERNATIONAL INC 2050A TUTTI FRUTTI BASE OIL
### I IV 11/14/1999 FONA INTERNATIONAL INC 852.049 N-C NATURAL AND ARTIFICIAL FUIT
PUNCH FLAVOR
### I IV 11/14/1999 FONA INTERNATIONAL INC 852.013 STRAW PUNCH FLAVOR(A NATURAL AND
ARTIFICIAL FLAVOR)
### I IV 11/14/1999 FONA INTERNATIONAL INC 2038A NATURAL AND ARTIFICIAL TROPICAL
FRUIT PUNCH FLAVOR
### I IV 11/14/1999 FONA INTERNATIONAL INC 2038B INTERMEDIATE B
Page 471
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I IV 11/14/1999 FONA INTERNATIONAL INC 856.039 N-C ARTIFICIAL CONCORD GRAPE
FLAVOR
### I IV 11/14/1999 FONA INTERNATIONAL INC 856.316 N-C ARTIFICIAL CONCORD GRAPE
FLAVOR
### I IV 11/14/1999 FONA INTERNATIONAL INC 856.107 N-C ARTIFICIAL CONCORD GRAPE
FLAVOR
### I IV 11/14/1999 FONA INTERNATIONAL INC 884.596 N-C ORANGE CREME FLAVOR
NATURAL(WONF)
### I IV 11/14/1999 FONA INTERNATIONAL INC 600.014 ACETALDEHYDE NATURAL 50%
SOLN/TRIACETIN
### I IV 11/14/1999 FONA INTERNATIONAL INC 10252A ORANGE CREAM FLAVOR
NATURAL(WONF)
### I IV 11/14/1999 FONA INTERNATIONAL INC 929.005 N-C ARTIFICIAL WATERMELON FLAVOR
### I IV 11/14/1999 FONA INTERNATIONAL INC 929.001 ARTIFICIAL WATERMELON FLAVOR
### I IV 11/14/1999 FONA INTERNATIONAL INC 807.216 N-C BERRY FLAVOR(AN ARTIFICIAL
FLAVOR)
### I IV 11/15/1999 FONA INTERNATIONAL INC 906.423 RASPBERRY FLAVOR ARTIFICIAL
### I IV 11/15/1999 FONA INTERNATIONAL INC 6788D NATURAL AND ARTIFICIAL RASPBERRY
CONC
### I IV 11/14/1999 FONA INTERNATIONAL INC 807.101 N-C NATURAL AND ARTIFICIAL BERRY
FLAVOR
### I IV 11/14/1999 FONA INTERNATIONAL INC 6922B NATURAL AND ARTIFICIAL BERRY OIL
### I IV 11/14/1999 FONA INTERNATIONAL INC 6711C ARTIFICIAL IRISONE
### I IV 11/14/1999 FONA INTERNATIONAL INC 825.032 N-C ARTIFICIAL WILD CHERRY FLAVOR
### I IV 11/14/1999 FONA INTERNATIONAL INC 825.029 ARTIFICIAL WILD CHERRY FLAVOR
### I IV 11/14/1999 FONA INTERNATIONAL INC 852.002 N-C NATURAL AND ARTIFICIAL FRUIT
PUNCH FLAVOR
### I IV 11/14/1999 FONA INTERNATIONAL INC 611B NATURAL AND ARTIFICIAL FRUIT PUNCH
FLAVOR
### I IV 11/14/1999 FONA INTERNATIONAL INC 852.017 N-C TUTTI FRUTTI FLAVOR(A NATURAL
FLAVOR)
### I IV 11/14/1999 FONA INTERNATIONAL INC 8539Z RUM FLAVOR (NATURAL)
### I IV 11/14/1999 FONA INTERNATIONAL INC 5839B COMPOUND 1036 NATURAL
### I IV 11/15/1999 FONA INTERNATIONAL INC 1837D ARTIFICIAL STRAWBERRY FLAVOR
### I IV 11/15/1999 FONA INTERNATIONAL INC 915.136 ARTIFICIAL STRAWBERRY BASE OIL
### I IV 11/15/1999 FONA INTERNATIONAL INC 258C ARTIFICIAL RUM ETHER
### I IV 11/15/1999 FONA INTERNATIONAL INC 915.697 N-C STRAWBERRY FLAVOR NATURAL
AND ARTIFICIAL
### I IV 11/15/1999 FONA INTERNATIONAL INC 10257A ARTIFICIAL STRAWBERRY OIL
### I IV 11/15/1999 FONA INTERNATIONAL INC 612.600 METHYL THIOBUTYRATE 1%
SOLN/ETOH(1208850)
### I IV 11/15/1999 FONA INTERNATIONAL INC 600.297 ALPHA AMYL CINNAMIC ALDEHYDE 1%
SOLN.PG
### I IV 11/15/1999 FONA INTERNATIONAL INC 612.500 METHYL SULFIDE 1%
SOLN/ETOH(1208750)
Page 472
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I IV 11/15/1999 FONA INTERNATIONAL INC 612.401 2-ME-2-PENTENAL 1%
SOLN/PG(1208420)
### I IV 11/15/1999 FONA INTERNATIONAL INC 906.300 N-C NATURAL AND ARTIFICIAL
RASPBERRY FLAVOR
### I IV 11/15/1999 FONA INTERNATIONAL INC 6788A ARTIFICIAL RASPBERRY KEY
### I IV 11/15/1999 FONA INTERNATIONAL INC STERILE PRODUCTS FACILITY IN LENOIR, NC.
### I IV 11/15/1999 FONA INTERNATIONAL INC 807.120 N-C TRIPLEBERRY FLAVOR ARTIFICIAL
### I IV 11/15/1999 FONA INTERNATIONAL INC 809.085 N-C NATURAL AND ARTIFICIAL
BLUEBERRY FLAVOR
### I IV 11/15/1999 FONA INTERNATIONAL INC 2915C ARTIFICIAL BLUEBERRY FLAVOR
### I IV 11/15/1999 FONA INTERNATIONAL INC 856.054 ARTIFICIAL CONCORD GRAPE BASE OIL
### I IV 11/14/1999 FONA INTERNATIONAL INC 981N NATURAL BLUEBERRY FLAVOR
### I IV 11/15/1999 FONA INTERNATIONAL INC 758A NATURAL BLUEBERRY FORTIFIER
### I IV 11/15/1999 FONA INTERNATIONAL INC 600.300 AMBRETTE SEED ABSOLUTE
### I IV 11/15/1999 FONA INTERNATIONAL INC 601.070 BORONIA ABSOLUTE 1%
SOLN/ETOH(1003600)
### I IV 11/15/1999 FONA INTERNATIONAL INC 601.090 BUCHU LEAF OIL 1% SOLN/ETOH
### I IV 11/15/1999 FONA INTERNATIONAL INC 606.400 GALBANUM RESINOIDE 1%
SOLN/ETOH(1013220)
### I IV 11/15/1999 FONA INTERNATIONAL INC 606.500 GERANIUM OIL CHINESE
### I IV 11/15/1999 FONA INTERNATIONAL INC 609.200 JASMIN ABSOLUTE 1%
SOLN/ETOH(1014625)
### I IV 11/15/1999 FONA INTERNATIONAL INC 612.010 MANDARIN PETT TRPLS 1% SOLN/ETOH
### I IV 11/14/1999 FONA INTERNATIONAL INC 915.005 N-C ARTIFICIAL STRAWBERRY FLAVOR
### I IV 11/14/1999 FONA INTERNATIONAL INC 915.004 ARTIFICIAL STRAWBERRY BASE OIL
### I IV 11/15/1999 FONA INTERNATIONAL INC 915.747 STRAWBERRY FLAVOR(AN ARTIFICIAL
FLAVOR)
### I IV 11/15/1999 FONA INTERNATIONAL INC 915.727 N-C STRAWBERRY FLAVOR NATURAL
AND ARTIFICIAL
### I IV 11/15/1999 FONA INTERNATIONAL INC 1837R N-C STRAWBERRY FLAVOR ARTIFICIAL
### I III 11/18/1999 AMPACET CORP 10799-A TALC POLYETHYLENE MASTERBATCH
### A II 11/29/1999 TEVA PHARMACEUTICAL INDUSTRIES SIMVASTATIN
LTD
### I II 11/30/1999 ERREGIERRE SPA NABUMETONE
### A III 11/25/1999 LOG PLASTIC PRODUCTS CO 1993 LTD PLASTIC BOTTLES
### I II 11/23/1999 SCHERING AKTIENGESELLSCHAFT ZK807834
### A II 11/23/1999 DR REDDYS LABORATORIES LTD KETOROLAC TROMETHAMINE USP
### A II 12/1/1999 AVANTI POLAR LIPIDS INC 1,2-DIERUCOYL-SN-GLYCERO-3-
PHOSPHOCHOLINE (DEPC)
### I II 11/19/1999 TEVA PHARMACEUTICALS USA INC CEFACLOR USP
### I II 11/3/1999 SIEGFRIED CHEMICALS INC ORGANIZATION G SITE BUILDING FACILITIES
AND OPERATION OF FACTORY IN TAOYUAN
TAIWAN ROC
### I II 11/5/1999 SIEGFRIED CHEMICALS INC VALPROIC ACID USP
### I III 11/29/1999 FLINT HILLS RESOURCES LP PP11530V POLYPROPYLENE
Page 473
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 12/7/1999 ANTIBIOTICE SA FACILITIES PERSONEL AND GENERAL
OPERATING PROCEDURES FOR FACTORY IN
IASI ROMANIA
### I III 11/19/1999 DEX PLASTOMERS ETHYLENE OCTENE COPOLYMERS
14611 I II 12/7/1999 R TECH UENO LTD UNOPROSTONE ISOPROPYL
### A II 12/9/1999 TEVA PHARMACEUTICAL INDUSTRIES METOPROLOL SUCCINATE
LTD
### I V 11/30/1999 GLAND PHARMA LTD STERILE FINISHED PRODUCTS AND STERILE
PROCESSING OPERATIONS LOCATED IN
AMEEPET AND DUNDIGAL, INDIA
### I II 12/9/1999 DAIICHI ASUBIO PHARMA CO LTD SUN A0026 DRUG SUBSTANCE
### I II 12/9/1999 SAFC INC 2-METHOXYESTRA-3,17 B-DIOL
### A II 12/2/1999 SAFC BIOSCIENCES INC EX-CELL PF CHO PART A (MODIFIED)
### A II 12/6/1999 SAFC BIOSCIENCES INC EX-CELL PF CHO MEDIUM (MODIFIED)
DEFICIENT
### A II 12/13/1999 MINAKEM HIGH POTENT VINORELBINE TARTRATE
### A IV 12/8/1999 WACKER BIOSOLUTIONS DIV OF BETA-CYCLODEXTRIN
WACKER CHEMIE AG
### A V 11/26/1999 BIOMERIEUX SA DESCRIPTION AND DATA TO SUPPORT USE OF
SOLID PHASE CYTOMETER FOR THE
MEASUREMENT OF VIABLE MICRO-ORGANISMS
IN PHARMACEUTICAL WATER SYSTEMS
### A II 12/10/1999 QUIMICA SINTETICA SA TERCONAZOLE
### I II 12/16/1999 SANOFI AVENTIS PYRAZINAMIDE
### I III 12/9/1999 COLOR MASTER INC BN11107E CHOCOLATE BROWN COLOR
CONCENTRATE FOR PLASTICS
### I III 12/9/1999 COLOR MASTER INC RD1583E 187C RED COLOR CONCENTRATE FOR
PLASTICS
### A II 12/16/1999 SPECGX LLC NOSCAPINE USP SMALL CRYSTALS CODE 6040
AND NOSCAPINE HYDROCHLORIDE PURIFIED
CODE 6150
### A II 12/17/1999 SANOFI AVENTIS DEUTSCHLAND GMBH CICLOPIROX
### A IV 12/15/1999 BAYER OY PDMS 373MI TUBING
### A IV 12/15/1999 BAYER OY 4910 UNFILLED ELASTOMER
### A II 12/15/1999 XIAN LIJUN PHARMACEUTICAL CO LTD ERYTHROMYCIN BASE USP 23
### A III 12/17/1999 TEKNI-PLEX GALLAZZI SRL FLEXAPHARM PRODUCTS
### I II 12/15/1999 LEIRAS OY G FACILITY EQUIPMENT AND PERSONEL FOR
SITE IN TURKU FINLAND
### I II 12/17/1999 SANOFI AVENTIS DEUTSCHLAND GMBH CICLOPIROX OLAMINE
### A III 12/2/1999 LONSTROFF AG BROMOBUTYL RUBBER COMPOUNDS
### I III 12/8/1999 SPARTECH COLOR WH 18485 WHITE POLYETHYLENE
CONCENTRATE
### A II 12/18/1999 CEDARBURG PHARMACEUTICALS INC BUTABARBITAL SODIUM, USP
### A II 12/20/1999 CIPLA LTD FLUTAMIDE USP
### I II 12/16/1999 INDUSTRIAS MONFEL SA DE CV ACETAMINOPHEN
Page 474
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/16/1999 EASTMAN CHEMICAL CO HYDROQUINONE USP
### I II 12/22/1999 ABBVIE INC 5-DESOSAMINYL-6-0-METHYL ERYTHRONOLIDE
### I II 12/23/1999 ARADIGM CORP AERX MORPHINE SULFATE PAIN MANAGEMENT
SYSTEM
### I III 12/22/1999 MAC CLOSURES INC PLASTIC DISPENSER
### I II 12/22/1999 CATALENT FRANCE BEINHEIM SA DUTASTERIDE SOFT GELATIN CAPSULES .5MG
### A IV 12/23/1999 DMV-FONTERRA EXCIPIENTS GMBH AND RESPITOSE ML001
CO KG
### I II 12/28/1999 TAIHO PHARMACEUTICAL CO LTD GTS-21
### A II 12/27/1999 PCAS DIVALPROEX SODIUM
### I II 12/28/1999 SUMITOMO CHEMICAL CO LTD MCC-555
### A II 12/28/1999 TARO PHARMACEUTICAL INDUSTRIES CLOBETASOL-17-PROPIONATE USP
LTD MICRONIZED
### I II 12/30/1999 MERCK AND CO INC OMEPRAZOLE MAGNESIUM
### I II 12/29/1999 SCHWEIZERHALL MANUFACTURING CO METYRAPONE
### A II 12/30/1999 TARO PHARMACEUTICAL INDUSTRIES BETAMETHASONE DIPROPIONATE USP,
LTD MICRONIZED
### A III 12/2/1999 MYLAN TECHNOLOGIES INC MEDIRELEASE 2249
### I II 1/3/2000 FAKO ILACLARI AS CEFUROXIME AXETIL AMORPHOUS
### I II 12/28/1999 TEVA GROUP ACYCLOVIR USP
### I II 12/29/1999 NAPP TECHNOLOGIES INC SULFABENZAMIDE
### A IV 12/7/1999 ROXLOR SA EMPTY GELATIN CAPSULES
### I II 12/25/1999 GLENMARK PHARMACEUTICALS LTD G SITE FACILITIES OPERATING PROCEDURES
AND PERSONEL FOR SATPUR NASIK INDIA SITE
### I II 1/7/2000 NANOSYSTEMS L-822,179 ORAL NANOCRYSTAL COLLOIDAL
DISPERSION-MEDIA MILLING PROCESS
### I II 1/6/2000 SYN-TECH CHEM AND PHARM CO LTD DILTIAZEM HYDROCHLORIDE USP
### A II 1/11/2000 NISSAN CHEMICAL CORP PITAVASTATIN CALCIUM
### A II 1/3/2000 INDUSTRIALE CHIMICA SRL ZOPICLONE
### I II 1/10/2000 BEIJING SECOND PHARMACEUTICAL ISONIAZID USP23
FACTORY
### A III 12/30/1999 POLYONE CORP CC00016123WE
### A III 12/30/1999 POLYONE CORP CC10004846WE
### A III 12/30/1999 POLYONE CORP CC00017504DR
### A III 12/30/1999 POLYONE CORP CC00017506WE/DR
### I III 12/30/1999 POLYONE CORP CC10004836WE
### A III 12/30/1999 POLYONE CORP CC00015904WE
### A III 12/30/1999 POLYONE CORP CC00022347DR
### A III 1/3/2000 ST GOBAIN PERFORMANCE PLASTICS ELASTOMERIC CLOSURES FOR ALUMINUM
FRANCE CONTAINERS & PHARMACEUTICAL VIALS
### I III 1/14/2000 WINPAK HEAT SEAL PACKAGING INC HEAT SEALABLE LIDDING
### I III 1/14/2000 AMCOR FLEXIBLES ITALIA SRL POLYESTER ALUMINUM/POLYETYLENE DRUG
WRAPPER PRODUCT W/ADHESIVE
### I III 12/30/1999 MA HANNA COLOR COLORANT PRODUCT #506324JEMB
Page 475
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 1/7/2000 BOOTS CO PLC G SITE FACILITIES OPERATING PROCEDURES
AND PERSONNEL FOR D95 G FACILITY LOCATED
IN NOTTINGHAM ENGLAND
### A II 1/13/2000 EUTICALS SPA INTERMEDIATE PERG/9 D-6-N-(PROPIONYL)-
8BETA-METHYLTHIOMETHYLERGOLINE
### I III 1/12/2000 FBG ANCHOR TUBULAR GLASS VIALS( I)
### I III 1/14/2000 WINPAK HEAT SEAL PACKAGING INC FOILGUARD LF1515E2Z
### I II 1/21/2000 YAKULT HONSHA CO LTD SN-38B-11 INTERMEDIATE COMPOUND
### A II 1/19/2000 LEK PHARMACEUTICALS DD CLAVULANATE POTASSIUM
### I V 1/21/2000 CHLOPROPHAM TASK FORCE ONE YEAR CHRONIC STUDY OF
CHLORPROPHAM IN DOGS AS PERFORMED BY
TPS INC IN MT VERNON INDIANA
### A III 1/20/2000 DANAPAK FLEXIBLES AS LAMINATE FILM FOR PACKAGING OF
PHARMACEUTICAL PRODUCTS, E.G.
TRANSDERMAL SYSTEMS
### I IV 1/24/2000 TAKASAGO INTERNATIONAL CORP TAK-990020 ARTIFICIAL RASPBERRY FLAVOR
### I IV 1/24/2000 TAKASAGO INTERNATIONAL CORP TAK-990021 ARTIFICIAL CHERRY FLAVOR
### I III 1/27/2000 SHINKONG SYNTHETIC FIBERS CORP SHINPET 5015W POLYETHYLENE
TERPHTHALATE COPOLYESTER
### A II 1/26/2000 CATALENT PHARMA SOLUTIONS LLC LOVAZA 1 G SOFT GELATIN CAPSULES(OMEGA-
3-ACID ETHYL ESTERS, 1 GRAM)
### I II 1/26/2000 CIPLA LTD PAMIDRONIC ACID
### I II 1/24/2000 3M PHARMACEUTICALS R-848 ORAL DRUG PRODUCT
### I II 1/17/2000 SALSBURY CHEMICALS INC SULFASALAZINE PVP
### I II 1/21/2000 QIAGEN GMBH QIAGEN NI-NTA AGAROSE
### I II 1/21/2000 QIAGEN GMBH NI-NTA SUPERFLOW
### I III 12/23/1999 ASPELL POLYMERES LACQTENE HD2002SN58U
### A II 1/31/2000 TEVA PHARMACEUTICAL INDUSTRIES ALCLOMETASONE DIPROPIONATE
LTD
### A II 2/1/2000 FARMABIOS SPA TRIAMCINOLONE ACETONIDE
### A II 2/15/2000 CORDEN PHARMA SWITZERLAND LLC 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-
PHOSPHOCHOLINE (POPC)
### I II 2/24/2000 DOW CHEMICAL CO SEVELAMER HYDROCHLORIDE
### I II 2/2/2000 METAFLUX AG METAFLUX 70-09 BIOLUB(SPRAY)
### I II 2/3/2000 EMISPHERE TECHNOLOGIES INC 5-CNAC
### A II 1/31/2000 EMBIO LTD PSEUDOEPHEDRINE SULFATE USP
### A II 2/2/2000 DR REDDYS LABORATORIES LTD CIPROFLOXACIN USP
### A II 2/2/2000 SUMITOMO SEIKA CHEMICALS CO LTD B-WING
### I III 2/3/2000 COLOR MASTER INC MT1161E FDA BRONZE COLOR CONCENTRATE
FOR PLASTICS
### A II 2/4/2000 COSMA SPA LABETALOL HYDROCHLORIDE
### A II 12/20/1999 TEVA PHARMACEUTICAL INDUSTRIES FLUDROCORTISONE ACETATE
LTD
### I II 2/2/2000 INTERNATIONAL ISOTOPES INC STRONTIUM SR-89 CHLORIDE
### I II 2/9/2000 EXCELLA GMBH FLUTAMIDE
Page 476
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 2/10/2000 NATURAL PHARMACEUTICALS INC PACLITAXEL API, ISOLATION AND PURIFICATION
FROM TAXUS BREVIFOLIA
### I III 1/28/2000 NORDEN PACK INTERNATIONAL AB PACKAGING MATERIAL FOR NICOTROL INHALER
### A III 2/14/2000 KLOCKNER PENTAPLAST EUROPE CYCLOOLEFIN MULTILAYER PACKAGING FILMS
GMBH AND CO KG
### A II 2/11/2000 CIPLA LTD CIPROFLOXACIN HYDROCHLORIDE USP
### I II 2/10/2000 WOCKHARDT LTD NIZATIDINE USP
14711 A II 2/15/2000 ERREGIERRE SPA NAFTIFINE HYDROCHLORIDE USP
### I II 2/29/2000 SERIPHARM SA 10-DEACETYL BACCATIN III
### A II 1/27/2000 PIRAMAL ENTERPRISES LTD DILTIAZEM HYDROCHLORIDE
### A II 12/15/1999 INKE SA FLUCONAZOLE
### A II 2/1/2000 PEPTIDO GMBH LEVOTHYROXINE SODIUM
### I III 2/18/2000 WINPAK TECHNOLOGIES INC PACKAGING MATERIAL FOR PHARMACEUTICAL
PRODUCTS
### A III 2/10/2000 PRETIUM PACKAGING LLC PLASTIC PACKAGING MATERIALS
### A II 2/18/2000 CERBIOS PHARMA SA CALCITRIOL
### I II 2/18/2000 IROTEC LABORATORIES FLUTAMIDE
### A II 2/21/2000 ALBEMARLE CORP BENAZEPRIL HYDROCHLORIDE
### A IV 2/22/2000 CP KELCO US INC GELLAN GUM GELRITE MK
### I II 2/23/2000 DIVISION OF CANCER TREATMENT AND PYROXAMIDE CMC AND PRECLINICAL
DIAGNOSIS PHARMACOLOGY AND TOXICOLOGY DATA
### I III 3/2/2000 DSM RESEARCH STAMYLAN P11E10
### I II 2/23/2000 ZHEJIANG JIUZHOU PHARMACEUTICAL SULFASALAZINE
CO LTD
### I III 2/9/2000 POLIMERI EUROPA FRANCE FLEXIRENE FG23F
### I III 2/9/2000 POLIMERI EUROPA FRANCE FLEXIRENE FG20F
### A II 2/29/2000 KEWPIE CORP SODIUM HYALURONATE
### I II 2/21/2000 PCAS CLOMIPHENE CITRATE
### A II 2/25/2000 TEVA PHARMACEUTICAL INDUSTRIES PRAVASTATIN SODIUM
LTD
### I II 3/14/2000 AVENTIS PHARMACEUTICALS INC MDL 105074
### I II 3/14/2000 AVENTIS PHARMACEUTICALS INC MDL 104036
### I II 2/25/2000 SOCIETA ITALIANA MEDICINALI MESNA
SCANDICCI
### I III 3/3/2000 COLOR MASTER INC BL1886E FDA282C DK BLUE COLOR
CONCENTRATE FOR PLASTICS
### I III 3/3/2000 COLOR MASTER INC BN1114E FDA DK BROWN COLOR
CONCENTRATE FOR PLASTICS
### I III 3/3/2000 COLOR MASTER INC GR1579E FDA 332C GREEN COLOR
CONCENTRATE FOR PLASTICS
### I III 3/3/2000 COLOR MASTER INC RD1369E FDA 2365 PINK COLOR CONCENTRATE
FOR PLASTICS
### I III 3/3/2000 COLOR MASTER INC RD1640E FDA182C PINK COLOR CONCENTRATE
FOR PLASTICS
Page 477
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 2/25/2000 COLOR MASTER INC RD1636E FDA PMS 182 PINK COLOR
CONCENTRATE FOR PLASTICS
### I III 2/25/2000 COLOR MASTER INC BL 1879E FDA PMS282 DK BLUE COLOR
CONCENTRATE FOR PLASTICS
### I III 2/25/2000 COLOR MASTER INC GR1573E FDA PMS332 GREEN COLOR
CONCENTRATE FOR PLASTICS
### I III 2/25/2000 COLOR MASTER INC RD1635E FDA PMS2356 PINK COLOR
CONCENTRATE FOR PLASTICS
### I II 3/1/2000 MOLECULAR MEDICINE LLC ADENOVIRUS
### I II 2/15/2000 OKAMI CHEMICAL INDUSTRY CO LTD TROPICAMIDE
### A III 3/1/2000 SOFFIERIA BERTOLINI SPA GLASS VIALS, GLASS AMPOULES AND GLASS
CARTRIDGES
### I III 2/24/2000 AKZO NOBLE INKS CORP WATER BASED PRINTING INK AND UV CURABLE
COATING PRODUCTS
### I II 2/29/2000 MEDI CULT AS G SITE FACILITIES OPERATING PROCEDURES
AND PERSONNEL LOCATED IN JYLLINGE
DENMARK
### I II 2/29/2000 MEDI CULT AS RENCYTE SYSTEM MEDIA
### I II 3/2/2000 PROCOS SPA MONOALDEHYDE
### A II 2/29/2000 AMSA ANONIMA MATERIE SINTETICHE FLECAINIDE ACETATE
AND AFFINI SPA
### I II 2/29/2000 SIFAVITOR SPA TIMOLOL MALEATE
### I II 3/8/2000 ZHEJIANG JUZHOU PHARMACEUTICALS SULFASALAZINE-PVP
CO LTD
### I II 9/1/1998 ABBOTT INDUSTRIES INC LINCOMYCIN HYDROCHLORIDE MONOHYDRATE
BULK
### I II 9/1/1998 FERMIC SA DE CV GENTAMYCIN SULFATE
### I II 9/1/1998 BIOCHIMICA OPOS SPA CEFACLOR BULK NON STERILE AADA
CONVERSION
### I II 9/1/1998 ABBOTT LABORATORIES CHEMICAL AND ERYTHROMYCIN ESTOLATE
AGRICULTURAL PRODUCTS DIV
### I II 9/1/1998 ABBOTT LABORATORIES CHEMICAL AND ERYTHROMYCIN ESTOLATE
AGRICULTURAL PRODUCTS DIV
### I II 3/6/2000 DSM MINERA BV SILVER SULFADIAZINE
### A III 3/8/2000 STELLA KUNSTSTOFFTECHNIK GMBH CHILD PROOF PACKAGING MATERIAL
### A II 3/7/2000 MIDORI KAGAKU CO LTD A-WING
### A III 2/24/2000 MULLER AND MULLER JOH GMBH CO KG TUBULAR GLASS INJECTION VIALS
Page 483
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I I 5/26/2000 SHENZHAN (CHINA) NEPTUNUS G FACILITIES, OPERATING PROCEDURES, AND
PHARMACEUTICAL CO., LTD. PERSONEL FOR PRODUCTION FACILITY
LOCATED IN NANSHAN DISTRICT, SHENZHEN,
GUANGDONG, CHINA
### I III 6/6/2000 NATIONAL PAPER AND PACKAGING INC GLASS CONTACTS: U-S-P 3 GLASS
### I II 6/20/2000 LILLY RESEARCH LABORATORIES DIV CEPHALEXIN MONOHYDRATE BULK
ELI LILLY AND CO
### I II 5/4/2000 CKD BIO CORP LOVASTATIN, NON-STERILE BULK, USP
### I II 6/15/2000 SANKYO CO LTD CS-505 DRUG SUBSTANCE
### A II 6/16/2000 3M DRUG DELIVERY SYSTEMS CLIMARA PRO(R)
ESTRADIOL/LEVONORGESTREL TRANSDERMAL
DELIVERY SYSTEM
### I II 6/15/2000 BAYER SCHERING PHARMA AG FLUDARABINE PHOSPHATE
### I II 6/18/2000 AVANTI POLAR LIPIDS INC 1,2-DIPALMITOYL-SN-GLYCERO-3-
PHOSPHOETHANOLAMINE(DPPE)
### I II 6/18/2000 AVANTI POLAR LIPIDS INC DC-30 LIPID BLEND
### A III 6/15/2000 EAGLE STAINLESS CONTAINER EAGLE STAINLESS CONTAINER
### A II 6/19/2000 CAMBREX CHARLES CITY INC OFLOXACIN USP
### I II 6/20/2000 NANO SYSTEMS CELECOXIB 200 MG FILM COATED TABLETS
### I II 6/21/2000 SAFC BIOSCIENCES INC EX-CELL 302 MEDIUM (GS MODIFIED), CATALOG
NO. 62639
### I II 6/15/2000 HYBRIDON INC G3139 A PHARMACEUTICAL INGREDIENT
### I III 6/26/2000 ZEON CORP ZEONOR 750R (CYCLOOLEFIN POLYMER)
### I IV 6/19/2000 TECHNOLOGY FLAVORS AND ARTIFICIAL CHERRY FLAVOR BRY-63
FRAGRANCES INC
### I III 6/19/2000 COLOR MASTER INC BN1025M, FDA TRANSPARENT AMBER COLOR
CONCENTRATE FOR PLASTICS
### I III 6/14/2000 COLOR MASTER INC BL1918E, PEARL MAG BLUE COLOR
CONCENTRATE FOR PLASTICS
### I II 6/22/2000 NORTHEAST GENERAL RIMANTADINE HYDROCHLORIDE, NON-STERILE
PHARMACEUTICAL FACTORY BULK DRUG SUBSTANCE CW-100
### A IV 6/20/2000 WACKER CHEMIE AG ALPHA-CYCLODEXTRIN.A DRUG SUBSTANCE
INTERMEDIATE USED IN THE PREPARATION OF
A DRUG PRODUCT
### I II 6/30/2000 CHEMSOURCE CORP ENALAPRIL MALEATE DRUG SUBSTANCE
### A IV 7/12/2000 HENRY H OTTENS MANUFACTURING CO NATURAL & ARTIFICIAL CITRUS FLAVOR # 9185
INC
### I II 7/3/2000 SHIONO FINESSE LTD TROPICAMIDE
### A II 7/3/2000 CATALENT PHARMA SOLUTIONS LLC PROMETRIUM 100-MG AND 200-MG SOFT-
GELATIN CAPSULE
### A II 6/26/2000 RECORDATI INDUSTRIA CHIMICA E PYRIDOXAL-5-PHOSPHATE
FARMACEUTICA SPA
### A III 5/5/2000 BERRY GLOBAL 11176-40
### A II 6/28/2000 TEVA PHARMACEUTICAL INDUSTRIES DIHYDROERGOTAMINE MESYLATE
LTD
Page 484
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 8/21/2000 TAKEHARA KAGAKU KOGYO CO LTD U-CAL SSS CALCIUM CARBONATE
### I II 7/3/2000 AMSA SPA CARTEOLOL HYDROCHLORIDE
### A II 6/29/2000 ERREGIERRE SPA BISACODYL USP-EP
### I II 6/30/2000 NAPP TECHNOLOGIES INC KETOCONAZOLE USP
### A III 7/7/2000 GERRESHEIMER BUNDE GMBH PREFILLABLE DISPOSABLE ALL GLASS SYRINGE
SYSTEMS MADE FROM TUBULAR GLASS TO BE
USED AS PRIMARY PACKAGING CONTAINERS
FOR PHARMACEUTICAL AND MEDICINAL
PRODUCTS
### A III 7/11/2000 SEKISUI ALVEO AG ALVEOLIT TL S
### A II 7/13/2000 NEULAND LABORATORIES LTD SOTALOL HYDROCHLORIDE USP
### I II 7/13/2000 HEALTH RESEARCH INC HUMAN PARAHYROID HORMONE, SYNTHETIC
[SPTH(1-34)]
### A II 7/14/2000 DAIICHI SANKYO CO LTD OLMESARTAN MEDOXOMIL DRUG SUBSTANCE
### I II 7/18/2000 DAIICHI PHARMACEUTICAL CO LTD DX-8951F DRUG SUBSTANCE
### A II 9/19/2000 KANEKA AMERICA CORP N-2-[1-(S)-ETHOXYCARBONYL]-N-6-
TRIFLUOROACETYL-1-LYSYL-N-2-CARBOXY
ANHYDRIDE(EPTL)
### I II 7/19/2000 DIOSYNTH BV HEPARIN SODIUM
### A III 7/18/2000 BILCARE LTD BILCARE PVDC COATED PVC FILM
### I II 7/20/2000 WL GORE AND ASSOC INC GORE FLUOROELASTOMER PERISTALTIC PUMP
TUBE
### I II 7/28/2000 SMITH KLINE AND FRENCH TICARCILLIN DISODIUM
LABORATORIES
### A II 7/25/2000 BAYER AG ETHINYLESTRADIOL-BETA-CYCLODEXTRIN-
CLATHRATE
### I II 7/27/2000 SMITH KLINE AND FRENCH TICARCILLIN MONOSODIUM
LABORATORIES
### I II 8/2/2000 SMLX TECHNOLOGIES INC INSULIN (HUMULIN) TRANSDERMAL PACHES
### I II 7/19/2000 NINGBO RENJIAN PHARMACEUTIAL CO HMG (HUMAN MENOPAUSAL GONADOTROPHIN)
LTD
### I II 7/25/2000 BOSTON BIOSYSTEMS EPI-2010 DRUG SUBSTANCE
### I II 7/25/2000 DSM FINE CHEMICALS INC FLOXURIDINE
### I II 7/25/2000 3M DRUG DELIVERY SYSTEMS DIV TRANSDERMAL DELIVERY SYSTEM CONTAINING
FENTANYL
### I II 7/20/2000 BOEHRINGER INGELHEIM PHARMA TROSPIUM CHLORIDE
GMBH AND CO KG
### A III 8/2/2000 MARUTANI CHEMICAL PLANT MK DESSICANT
ENGINEERING CO LTD
### I II 7/31/2000 SANYO FINE CO LTD OMEPRAZOLE
### A II 7/31/2000 CORDEN PHARMA SWITZERLAND LLC 1,2-DISTEAROYL-SN-GLYCERO-3-
PHOSPHOCHOLINE (DSPC)
### A II 7/19/2000 PROCOS SPA ORPHENADRINE CITRATE
### A II 7/31/2000 ERREGIERRE SPA SULCONAZOLE NITRATE USP
### I II 7/27/2000 BIOCHEM CORP PROTAMINE SULFATE
Page 485
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 8/4/2000 EUMEDICA PHARMACEUTICALS SULBACTAM SODIUM USP
INDUSTRIES SL
### A IV 7/31/2000 MITSUBISHI CHEMICAL CORP EXCIPIENTS SUCROSE FATTY ACID
ESTERS(SUCROSE STEARIC ACID ESTERS,
SUCROSE PALMITIC ACID ESTERS AND
SUCROSE LAURIC ACID ESTERS)
### I II 7/28/2000 CHEMI SPA 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-
PHOSPHOGLYCEROL AMMONIUM SALT 95%
POSITIONAL PURITY
### A II 8/1/2000 CADILA HEALTHCARE LTD HYDROXYCHLOROQUINE SULFATE USP
### I II 9/6/2000 ELAN PHARMACEUTICAL RESEARCH FAMPRIDINE SR TABLETS
CORP
### A II 7/26/2000 LUSOCHIMICA SPA NIMODIPINE
### A III 7/24/2000 POLYONE CORP CC00012984D4/WE
### I II 8/4/2000 CHINOIN PHARMACEUTCIAL AND PGE1 ETHYL ESTER
CHEMICAL WORKS CO LTD
### I II 7/25/2000 TEVA GROUP SULFAMETHOXAZOLE USP
### I II 8/2/2000 ALCHYMARS SPA ALENDRONATE SODIUM
### I II 8/3/2000 PROLIGO LLC GTI-2040 DRUG SUBSTANCE
### A II 8/29/2000 CAMBREX PROFARMACO MILANO SRL PROPAFENONE HYDROCHLORIDE
### I III 7/31/2000 BETTS UK LTD BETTS UK LTD LAMINATE TUBES
### A II 7/25/2000 SUN PHARMACEUTICAL INDUSTRIES PENTOXIFYLLINE USP
LTD
### I II 8/8/2000 NIPPON SODA CO LTD FAROPENEM DALOXATE
### A IV 8/24/2000 QUALICAPS CO LTD EDIBLE INKS
### I IV 8/10/2000 FMC CORP LUSTRECLEAR N MICROCRYSTALLINE
CELLULOSE/CARRAGEENAN-BASED COATING
### A II 5/26/2000 HOVIONE FARMACIENCIA SA MOMETASONE 17-FUROATE
### I II 8/10/2000 GLAXO WELLCOME INC CEFUROXIME AXETIL BULK DRUG SUBSTANCE
### A IV 8/8/2000 DUPONT NUTRITION USA INC SODIUM ALGINATE
### A II 8/4/2000 POLYPEPTIDE LABORATORIES INC OCTREOTIDE ACETATE DRUG SUBSTANCE
### I II 8/14/2000 SUN PHARMACEUTICAL INDUSTRIES LISINOPRIL USP (NON-STERILE BULK)
LTD
### A II 8/15/2000 MACCO ORGANIQUES SRO CALCIUM CHLORIDE DIHYDRATE USP
### I II 8/15/2000 SHANGHAI SINE PHARMACEUTICAL BIFICO
CORP LTD
### I III 8/3/2000 BASF AKTIENGESELLSCHAFT TERLURAN GP-22NATURAL
### A III 8/11/2000 INEOS ABS USA CORP LUSTRAN ABS 308-1000
### I III 8/3/2000 BASF AKTIENGESELLSCHAFT TERLURAN GP-35 NATURAL
### I II 8/10/2000 OTSUKA PHARMACEUTICAL CO LTD REBAMIPIDE(OPC-12759) DRUG SUBSTANCE
### I II 8/15/2000 CUNO INC ZETA PLUS M SERIES GRADED DENSITY MEDIA
AND CARTIDGE PRODUCTS
### A II 9/11/2000 BOEHRINGER INGELHEIM PHARMA EPINASTINE HYDROCHLORIDE
GMBH AND CO KG
Page 486
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 8/18/2000 TARO PHARMACEUTICAL INDUSTRIES BETAMETHASONE 17-VALERATE, USP
LTD MICRONIZED
### I II 8/21/2000 KRKA DD NOVO MESTO ENALAPRILA USP
### I II 8/17/2000 IRVINE SCIENTIFIC SALES CO INC IS-CHO
### I II 8/22/2000 TECHNOLOGY COMMERCIALIZATION ACCELERATOR-PRODUCED PALLADIUM-103 (103
INTERNATIONAL INC PD) MEDICAL RADIOISOTOPE
### A III 8/17/2000 AMPACET CORP 100664 MOLD RELEASE POLYETHYLENE
MASTERBATCH
### I II 8/18/2000 SAFC BIOSCIENCES INC EX-CELL PF CHO MEDIUM (MODIFIED) CATALOG
NO. 67480
15011 I II 8/22/2000 INTERNATIONAL ISOTOPES INC SODIUM IODIDE I-123 RADIOCHEMICAL
### A III 9/20/2000 POLYFIL CORP POLYFIL CONCENTRATES ABC5000 AND MT5000
Page 490
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 11/10/2000 ELAN PHARMACEUTICAL RESEARCH N1179(BMS-347070-01)NANO CRYSTAL SPRAY
CORP GRANULATED INTERMEDIATE
### I II 11/13/2000 NEULAND LABORATORIES LTD RANITIDINE HYDROCHLORIDE USP
### A III 11/15/2000 BERRY GLOBAL SVP PLASTIC BOTTLES
### I II 11/20/2000 VIBRANTIS SA DE CV METFORMIN HYDROCHLORIDE
### I II 11/20/2000 ACS DOBFAR SPA CEFAZOLIN FOR INJECTION 100G & 300G
PHARMACY BULK PACKS
### A II 11/17/2000 CIPLA LTD CETIRIZINE DIHYDROCHLORIDE USP
### I II 11/22/2000 CHR HANSEN INC CAL-CARB 4457 (91:9 CALCIUM
CARBONATE/STARCH GRANULATION)
### A II 11/17/2000 HERAEUS DEUTSCHLAND GMBH AND CARBOPLATIN USP
CO KG
### A II 11/16/2000 OLON SPA METFORMIN HYDROCHLORIDE
### A II 11/20/2000 BAYER AG ASPIRIN USP
### I II 11/20/2000 DESERET LABORATOTRIES INC 90:10 CALCIUM CARBONATE/STARCH
GRANULATION
### I II 11/21/2000 PHILLIPS PLASTICS CORP 5-CNAC DI-SODIUM SALT
### A III 11/20/2000 BERRY GLOBAL CHILD-RESISTANT PUSH & TURN CLOSURES
### I III 11/20/2000 MAC CLOSURES INC TAMPER-EVIDENT CLOSURES
### I II 11/15/2000 MERCK KGAA EMD 68 843
### I II 11/21/2000 RANKE QUIMICA SL LAS 34475
### I II 11/21/2000 SUN PHARMACEUTICAL INDUSTRIES LORAZEPAM USP
LTD
### I II 11/24/2000 DOTTIKON EXCLUSIVE SYNTHESIS AG 2-CHLORO-3-(4 FLUOROBENZYL)-BENZIMIDE
HYDROCHLORIDE(FBI HCL)
### A II 11/22/2000 ZHEJIANG RUIBANG LABORATORIES INC THIOSTREPTON USP (NON-STERILE BULK
FORM)
### A II 11/27/2000 NATIONAL INSTITUTES HEALTH (S)-(+)-METHAMPHETAMINE HYDROCHLORIDE
NATIONAL INSTITUTE DRUG ABUSE
### I III 1/10/2001 TEK PACKAGING GROUP PACKAGING MATERIALS
### A II 11/27/2000 CIPLA LTD FLUCONAZOLE USP
### I II 11/27/2000 THERAPLEX CORP PACLITAXEL SUBSTANCE
### I II 11/28/2000 SOUTHWEST SYNTHETIC BUSPIRONE HYDROCHLORIDE
PHARMACEUTICAL GENERAL FACTORY
### I II 11/27/2000 LIPOTEC SA LEUPROLIDE ACETATE NON-STERILE BULK
DRUG SUBSTANCE
### A II 11/27/2000 BACHEM AG SINCALIDE
### I II 11/14/2000 F2 CHEMICALS LTD PERFLUOROBUTANE
### A II 11/28/2000 JINAN JINDA PHARMACEUTICAL DANTROLENE SODIUM NON-STERILE BULK
CHEMISTRY CO LTD DRUG SUBSTANCE
### A II 11/30/2000 SIGNA SA DE CV PIRFENIDONE EP
### I II 11/29/2000 SUN PHARMACEUTICAL INDUSTRIES ISOTRETINOIN USP (NON-STERILE BULK)
LTD
### I II 11/29/2000 SUN PHARMACEUTICAL INDUSTRIES MIDAZOLAM (NON-STERILE BULK) USP
LTD
Page 491
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/1/2000 UNION QUIMICO FARMACEUTICA SA MINOCYCLINE HYDROCHLORIDE USP
(UQUIFA SA)
### A II 12/6/2000 ESTEVE QUIMICA SA MOEXIPRIL HYDROCHLORIDE
### I II 11/30/2000 JENAHEXAL PHARMA GMBH 0.9% SODIUM CHLORIDE INJECTION,USP-
1ML/2ML AMPOULE
### A II 12/4/2000 FERMION OY GLIPIZIDE
### I III 1/15/2001 ROHM AND HAAS CO ADCOTE 15P6M
### I II 11/28/2000 ALDRICH CHEMICAL CO INC ROSE BENGAL, DISODIUM SALT, SIGMA-
ALDRICH CHEMICAL CO. PRODUCT NUMBER
W184-3
### I III 12/1/2000 NEMERA BUFFALO GROVE LLC ACTUATORS AND DUST CAP FOR INHALATION
AEROSOL
### A II 12/1/2000 ZHEJIANG HISUN PHARMACEUTICAL CO CYCLOPHOSPHAMIDE USP
LTD
### I IV 11/14/2000 BHARTI HEALTHCARE LTD EMPTY HARD GELATIN CAPSULES
### I II 12/6/2000 GALENA AS PERGOLIDE MESYLATE
### I II 12/4/2000 EXCELLA GMBH DICLOFENAC SODIUM
### I II 12/7/2000 NEOMPS INC MPS-69 (SYNTHETIC PEPTIDE)
### I III 12/5/2000 LPS INDUSTRIES INC VF60(METALIZED POLYESTER/LLDPE
LAMINATION)
### I II 12/7/2000 BOEHRINGER INGELHEIM CHEMICALS DEXRAZOXANE
INC
### A III 12/7/2000 CORMACK PACKAGING PTY LTD CORMACK/KERR CR-III 2 PIECE CHILD
RESISTANT CLOSURE (CRC)
### I III 12/5/2000 CORMACK PACKAGING PTY LTD CORMACK/KERR CR-I 2 PIECE CHILD
RESISTANT CLOSURE (CRC)
### A II 12/7/2000 WAVELENGTH ENTERPRISES LTD MOMETASONE FUROATE
### I III 12/6/2000 QENOS PTY LTD GF7660 WHITE 22 HDPE
### I II 12/11/2000 TEVA PHARMACEUTICAL INDUSTRIES LEUPROLIDE ACETATE
LTD
### I IV 1/12/2001 PENWEST PHARMACEUTICALS CO TIMERX-A CONTROLLED RELEASE SYSTEM
### I II 12/15/2000 ZENTIVA KS TETRAHYDROZOLINE HYDROCHLORIDE USP
### I II 12/18/2000 SUN PHARMACEUTICAL INDUSTRIES CEFPODOXIME PROXETIL USP
LTD
### A II 12/19/2000 NEOPHARMA JAPAN CO LTD MYCOPHENOLIC ACID, TECHNICAL GRADE
(INTERMEDIATE)
### I II 12/18/2000 SUN PHARMACEUTICAL INDUSTRIES CEFPODOXIME ACID
LTD
### A II 12/4/2000 SIEGFRIED EVIONNAZ SA CARBAMAZEPINE (CARBATOL)
### I II 12/13/2000 CUNO INC ZETA PLUS VIRAL REMOVAL MEDIA
### I III 12/11/2000 MATRIX PACKAGING INC PLASTIC CONTAINERS
### I III 12/14/2000 PERLOS CORP TURBUHALER M3
### I II 12/13/2000 PROLIGO LLC OLIGONUCLEOTIDE GTI-2501
### I II 11/12/2000 SOUTHERN HERBALS LTD PACLITAXEL DRUG SUBSTANCE
### A III 12/18/2000 STERI-PLAS PTY LTD 70ML TABLET BOTTLE
Page 492
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 12/20/2000 IWATA GLASS INDUSTRIAL CO LTD AMPULES AND VIALS
### I IV 12/18/2000 CERESTAR USA INC ERYTHRITOL
### I IV 12/19/2000 KEWPIE CORP PHOSPHATIDYCHLOLINE DRUG EXCIPIENT
### A III 11/30/2000 EASTMAN CHEMICAL CO EASTAPAK, VORIDIAN, AND EASTAR POLYMER
PRODUCTION
### I IV 12/20/2000 INTERNATIONAL SPECIALTY PRODUCTS DIAZOLIDINYL UREA,(GERMALL II)
### A III 12/18/2000 STERI-PLAS PTY LTD 115 ML TABLET BOTTLE
### A II 12/19/2000 SANOFI AVENTIS DEUTSCHLAND GMBH RAMIPRIL
### A III 12/21/2000 GERRESHEIMER BUNDE GMBH CONTAINERS MADE FROM TUBULAR GLASS AS
AMPOULES, BULK SYRINGES, CARTRIDGES AND
VIAL UP TO 100ML TO BE USED AS PRIMARY
PACKAGING CONTAINERS FOR
PHARMACEUTICAL AND MEDICINAL PRODUCTS
### A II 12/21/2000 OLAINFARM JSC RIMANTADINE HYDROCHLORIDE
15211 A II 12/26/2000 LEK PHARMACEUTICALS DD CLAVULANATE POTASSIUM
### A IV 12/27/2000 SUHEUNG CO LTD GELATIN AND HYDROXYPROPYL
METHYLCELLULOSE HARD SHELL CAPSULES
### A II 12/20/2000 CORDEN PHARMA BERGAMO SPA BETHANECHOL CHLORIDE
### I IV 5/8/2000 FONA INTERNATIONAL INC #884.167 N-C NATURAL ORANGE FLAVOR
(WONF) (TG-4NA)
### I IV 12/22/2000 FONA INTERNATIONAL INC #937.129 BITTERING FLAVOR, NATURAL
### A III 12/27/2000 POLYONE CORP CC00016405DR/WE
### A II 1/2/2001 HARMAN FINOCHEM LTD METFORMIN HYDROCHLORIDE
### A II 12/27/2000 CAMBREX KARLSKOGA AB HYDROUS BENZOYL PEROXIDE
### I II 12/22/2000 CAMBREX CHARLES CITY INC CETIRIZINE DIHYDROCHLORIDE
### I II 12/30/2000 BACHEM CALIFORNIA THYMOSIN ALPHAS-1 (BULK)
### I II 1/3/2001 DIOSYNTH BV NALTREXONE
### I II 1/3/2001 TEVA PHARMACEUTICAL INDUSTRIES TORSEMIDE
LTD
### I II 1/4/2001 STERLING SRL MEDROXYPROGESTERONE ACETATE
### I III 7/19/2000 PCI SERVICES INC PACKAGING MATERIAL
### I III 12/13/2000 COLOR MASTER INC BL2017E, 638C FDA BLUE COLOR
CONCENTRATE FOR PLASTICS
### I II 1/4/2001 WUXI SHANHE GROUP NO 1 ACETAMINOPHEN (PARACETAMOL)
PHARMACEUTICAL CO LTD
### I II 1/3/2001 MEMORIAL SLOAN KETTERING CANCER SODIUM IODIDE-124
CENTER
### A II 1/4/2001 ORCHID PHARMA LTD 7-AMINO-DESACETOXY-CEPHALOSPORANIC
ACID
### I II 1/8/2001 DSM DERETIL D(-)PHENYLGLYCINE AMIDE
### I III 1/2/2001 ALUPAK DOO HEAT-WELDING ALUMINUM FOIL, THICKNESS
0.020MM FOR HEA-SEALING ON PVC AND PVDC
(BLISTERFOIL)
### I II 12/21/2000 PARTICLE DYNAMICS INC DESTAB CALCIUM SULFATE 90 A/A
### I II 10/5/2000 SAN FU CHEMICAL CO LTD BENZOIC ACID
Page 493
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 1/4/2001 ACS DOBFAR SPA CEFUROXIME FOR INJECTION (75G AND 225G
BULK PACKS)
### I II 12/21/2000 LUITPOLD PHARMACEUTICALS INC STERILE WATER FOR INJECTION,USP
### I II 12/28/2000 LUITPOLD PHARMACEUTICALS INC NEUTRA-CAINE (SODIUM BICARBONATE
INJECTION) USP 7.5%
### A II 12/28/2000 LUITPOLD PHARMACEUTICALS INC METHYLENE BLUE INJECTION, USP 1%
### I II 1/12/2001 KYOWA HAKKO KIRIN CO LTD KRN7000
### I III 12/19/2000 AMPACET CORP 11989-DI WHITE POLYETHYLENE MASTERBATCH
### I IV 2/8/2001 FONA INTERNATIONAL INC #825.321 N-C ARTIFICIAL CHERRY FLAVOR
### I IV 2/8/2001 FONA INTERNATIONAL INC 825.662 ARTIFICIAL CHERRY FLAVOR
### I III 2/9/2001 HARCOSTAR DRUMS LTD 0008E FOR 60L OPEN TOP PLASTIC PACKAGING
(60L UNIVERSAL)
### I II 1/31/2001 SUMITOMO SEIKA CHEMICALS CO LTD KETOSULFONE
### A II 2/8/2001 BIDACHEM SPA CROTAMITON
### A III 2/5/2001 HEINKE TECHNOLOGY INC PREFILLED VAGINAL APPLICATOR
### A II 2/12/2001 TEVA PHARMACEUTICAL INDUSTRIES MUPIROCIN
LTD
### I II 2/27/2001 ELI LILLY AND CO CAPREOMYCIN SULFATE, STERILE BULK
(CAPASAT)
### A II 2/15/2001 OLON SPA PHENTERMINE HYDROCHLORIDE
### I II 2/16/2001 DSM PHARMACEUTICALS INC CLINDAMYCIN PHOSPHATE
### I II 2/19/2001 SIFAVITOR SPA THALIDOMIDE
### I II 2/14/2001 ORGAMOL SA CDT-PHOSPHATE
### A II 2/15/2001 CATALENT PHARMA SOLUTIONS LLC NIFEDIPINE (10MG AND 20MG) SOFTGEL
CAPSULE
### A IV 1/12/2001 HENRY H OTTENS MANUFACTURING CO FLAVOR POTENTIATOR S-100
INC
Page 495
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 2/14/2001 AMPACET CORP 11748 WHITE POLYETHYLENE MASTERBATCH
### I III 1/31/2001 3M DRUG DELIVERY SYSTEMS SCOTCHPAK 9739 (2-MIL POLYESTER LAMINATE)
Page 496
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 3/12/2001 BUNDER GLAS GMBH PLASTIC BOTTLES AND DROPPER BOTTLE
SYSTEMS FOR OPHTHALMIC PRODUCTS AND
OTHER APPLICATIONS UP TO CONTENTS OF
250ML CAPACITY
### I II 3/14/2001 XINJIANG HESHUO EPHEDRINE PSEUDOEPHEDRINE HYDROCHLORIDE
PRODUCT CO LTD
### I II 3/30/2001 EVONIK DEGUSSA GMBH N6-TRIFLUORACETYL-L-LYSYL-L-PROLINE
### I III 4/4/2001 TECH GROUP INHALATION ACTUATORS PACKAGING
MATERIALS
### I II 3/15/2001 CATALENT PHARMA SOLUTIONS LLC LANOXICAPS (0.5, 0.10, AND 0.20MG) SOFTGEL
CAPSULES
### A III 3/27/2001 A SCHULMAN INC POLYMER BLENDS
### I II 3/19/2001 SPI PHARMA INC MAGNESIUM HYDROXIDE PASTE/POWDER USP
### A II 2/21/2001 CAMBREX CHARLES CITY INC PURIFIED D-AMPHETAMINE BASE
### A II 4/13/2001 TARO PHARMACEUTICAL INDUSTRIES ETODOLAC USP MICRONIZED
LTD
### A II 2/21/2001 CAMBREX CHARLES CITY INC PURIFIED D, L-AMPHETAMINE BASE
### I IV 2/5/2001 ALPINE AROMATICS INTERNATIONAL INC SKIN CARE FRAGRANCE#223-520
### I III 3/9/2001 BERRY PLASTICS CORP PRODUCT 24-5-141
### A V 12/14/2000 WEST PHARMACEUTICAL SERVICES INC CONTRACT LABORATORY TEST METHODS
### I III 3/21/2001 AMPACET CORP STERILE FINISHED PRODUCTS AND STERILE
PROCESSING OPERATIONS AT THE VIALE
ADDETTA PLANT IN MILANO, ITALY
### I II 3/20/2001 WEX PHARMACEUTICALS INC TETRODOTOXIN DRUG SUBSTANCE
### A II 3/23/2001 3M PURIFICATION INC BETAFINE® PLEATED POLYPROLYLENE
CARTRIDGE PRODUCTS (BETAFINE® D SERIES,
BETAFINE® XL SERIES, AND BETAFINE® PP & PG
SERIES)
### I III 3/26/2001 NAMPAK PERSONAL CARE 15ML PHARMAPAC BOTTLE
### I III 3/26/2001 CONSOLIDATED CONTAINER CO LLC PACKAGING MATERIAL
### I III 3/26/2001 ALUPAK DOO PRINTED HEAT WELDING ALUMINUM FOIL
### A II 3/28/2001 RELIABLE BIOPHARMACEUTICAL LLC FLOXURIDINE
### A II 3/28/2001 SOLARA A PHARMA SCIENCES LTD METHOHEXITAL USP
### I IV 3/22/2001 EXXONMOBIL CHEMICAL CO VISTANEX POLYISOBUTYLENE RUBBER
### I III 3/23/2001 ROHM AND HAAS CO GREEN BAY ADHESIVE 103
### I III 3/26/2001 BECTON DICKINSON PHARMACEUTICAL BD MONOVIAL LUER AXS
SYSTEMS
### A II 4/12/2001 TEVA PHARMACEUTICAL INDUSTRIES DOXERCALCIFEROL DRUG SUBSTANCE
LTD
### I III 3/30/2001 WINPAK HEAT SEAL PACKAGING INC PACKAGING MATERIALS
### I II 3/29/2001 PISGAH LABS INC IMIPRAMINE PAMOATE
Page 497
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 3/30/2001 ELAN PHARMACEUTICAL RESEARCH BICIFADINE TABLETS
CORP
### A II 3/29/2001 GEDEON RICHTER PLC AZELASTINE HCL USP
### I II 4/4/2001 RANBAXY LABORATORIES LTD FLUOXETINE HYDROCHLORIDE
### A IV 3/30/2001 ZEON CORP QUINTAC 3570C (AN EXCIPIENT)
### A II 4/2/2001 DIVIS LABORATORIES LTD NABUMETONE USP
### I II 4/1/2001 PHARMACEUTICAL FINE CHEMICALS METAXALONE
PFC BAHAMAS LTD
### A II 4/10/2001 UNIQUE CHEMICALS (A DIV OF J B DICLOFENAC ACID
CHEMICALS AND PHARMACEUTICALS
LTD)
### I II 3/30/2001 WUHAN WUYAO PHARMACEUTICAL CO NOREPINEPHRINE BITARTRATE USP, NON-
LTD STERILE, BULK DRUG
### I II 4/10/2001 GENTA INC DJ-927 DRUG SUBSTANCE
### A III 4/5/2001 NOLATO JAYCARE LTD ANTIBIOTIC BOTTLES WITH POURER NECK
### A III 4/10/2001 INEOS CHLORVINYLS BELGIUM NV NORVINYL S5902
### I III 4/10/2001 CREATIVE FORMING POLYETHYLENE TEREPHTHALATE SHEET
### I III 4/4/2001 CATALENT GERMANY SCHORNDORF PACKAGING MATERIALS
GMBH
### I III 4/5/2001 DUPONT POLYESTER KALIDAR X70
### A III 4/2/2001 POLYONE CORP CC00004396WE
### A II 4/5/2001 QUIMICA SINTETICA SA SUMATRIPTAN SUCCINATE
### I II 4/6/2001 ZHUHAI UNITED LABORATORIES CO LTD AMOXICILLIN USP BULK SUBSTANCE
### I III 4/5/2001 HEINKE TECHNOLOGY INC PREFILLED VAGINAL APPLICATOR
### I III 4/9/2001 LIQUITANE ROCHESTER PACKAGING MATERIAL
### I III 4/10/2001 CHROMA CORP PC2118C 20/1 WHITE COLOR CONCENTRATE
### I II 4/11/2001 LONZA INC CDT PHOSPHATE
### I II 4/16/2001 TAIHUA NATURAL PLANT PACLITAXEL
PHARMACEUTICAL CO LTD
### A IV 5/7/2001 WACKER CHEMIE AG HDK N20 PHARMA
### A II 5/8/2001 JANSSEN PHARMACEUTICA NV GALANTAMINE HYDROBROMIDE DRUG
SUBSTANCE(SYNTHETIC)
### A II 4/18/2001 SPECGX LLC DEXTROAMPHETAMINE SULFATE USP
### A IV 4/18/2001 HEBEI WENDA CHEMICALS CO LTD EFFERVES (AMINO ACID COMPLEX)
### I III 4/12/2001 SOLUTIA INC CPFILMS WATER BASED DEEP DYED FILMS
### I II 4/18/2001 PROLIGO THIOATES LLC OLIGONUCLEOTIDE INX-3001
### I III 4/30/2001 CLARIANT CANADA INC 01SHI-227, STYRENE WHITE MASTERBATCH
### I III 10/4/2000 PLASDENE GLASS PAK CLINICAL TRIALS BY ECOG IN BROOKLINE,
MASSACHUSETTS.
### I II 4/3/2001 INDUSTRIES MONFEL S.A. DE C.V. ACETYLSALICYLIC ACID
### A III 4/25/2001 WESTLAKE LONGVIEW CORP EMAC SPECIALTY COPOLYMERS
### A III 4/17/2001 INEOS OLEFINS AND POLYMERS USA INEOS POLYPROPYLENE H20E-00
### A III 4/5/2001 NOLATO JAYCARE LTD COPHARM BOTTLE
### I III 4/5/2001 COPE ALLMAN PLASTIC PACKAGING LTD 2 PIECE PUSH-LOK CRC CLOSURE
Page 498
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 4/17/2001 SOLUTIA INC CLEARSIL RELEASE FILMS
### I II 4/19/2001 CEDARBURG PHARMACEUTICALS LLC DOXERCALCIFEROL
### I II 4/13/2001 IPCA LABORATORIES LTD TRICLOSAN
### I III 4/18/2001 BASELL POLIOLEFINE ITALIA SPA LUPOLEN 1810 D
### A III 4/18/2001 WESTLAKE PETROCHEMICALS LP LINEAR LOW-DENSITY POLYETHYLENE RESINS
### A IV 4/26/2001 ACG ASSOCIATED CAPSULES PVT LTD EXCIPIENT HARD GELATIN CAPSULE SHELLS
### A II 4/25/2001 POLYPEPTIDE LABORATORIES INC HUMAN SECRETIN ACETATE DRUG SUBSTANCE
Page 502
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 5/31/2001 FUJIMORI KOGYO CO LTD RELEASE LINER FILM FOR USE IN
TRANSDERMAL DRUG DELIVERY PATCHES E-
0010 NO. 33
### I II 7/25/2001 ASH STEVENS INC FLUDARABINE PHOSPHATE (ASP)
### I II 6/20/2001 WOCKHARDT LTD D-OXYPHENE BASE
### A III 7/20/2001 AR LA VE S SRL PACKAGING MATERIALS AMPOULES I GLASS
### A II 7/25/2001 DIPHARMA FRANCIS SRL TRAMADOL HCL
### I II 6/29/2001 MEMORIAL SLOAN KETTERING CANCER [I124] FIAU
CENTER
### A IV 7/15/2001 NITTA GELATIN INDIA LTD GELATIN
### I II 7/26/2001 JOST CHEMICAL CO MAGNESIUM CITRATE
### I III 7/24/2001 AMPACET CORP 110361 WHITE POLYETHYLENE MASTERBATCH
### I II 7/24/2001 FRESENIUS KABI ANTI INFECTIVES SRL CEFUROXIME SODIUM STERILE
### I II 7/11/2001 CAREFUSION CORP VIANOX-H (NITRIC OXIDE)
### A II 7/27/2001 CATALENT PHARMA SOLUTIONS LLC ADVIL PM LIQUI-GELS
### A II 7/31/2001 CALYX CHEMICALS AND PYRAZINAMIDE USP
PHARMACEUTICALS LTD
### A V 7/26/2001 ADVANCED MICRODEVICES PVT LTD MEMBRANE DISC AND CARTRIDGE FILTERS
USED FOR STERILIZATION OF DRUG PRODUCTS
### I II 10/10/2001 LUITPOLD PHARMACEUTICALS INC SODIUM CHLORIDE INJECTION 0.9% 4ML FILL IN
A 5ML VIAL
### A IV 10/9/2001 CAPSUGEL INC CAPSULE FOR INHALATION FOR BOEHRINGER
INGELHEIM
### I II 10/12/2001 GILEAD SCIENCES INC FK506LC AND PLACEBO
### I II 10/12/2001 ELAN PHARMACEUTICAL BUDESONIDE NANOCRISTAL COLLOIDAL
TECHNOLOGIES DISPERSION
### I II 10/10/2001 MALLINCKRODT INC NALMEFENE HYDROCHLORIDE
### I II 10/15/2001 RESOLUTION CHEMICALS LTD AZOTHIAPRINE USP
### A II 10/16/2001 POLYCARBON INDUSTRIES INC DBA PCI PYRIDOSTIGMINE BROMIDE USP
SYNTHESIS
### I II 10/15/2001 SIFA LTD BMS 20783-01
### I II 10/15/2001 DSM PHARMA CHEMICALS FLUMOL 50(35-60% FLUMOL IN ACETONITRIL)
NETHERLANDS BV
### I II 10/13/2001 AVANTI POLAR LIPIDS INC 1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHO-L-
SERINE(SODIUM SALT) (DOPS)
### A IV 10/10/2001 NIPPON SHINYAKU CO LTD CLZ-42
### I II 10/16/2001 RANBAXY LABORATORIES LTD CEFUROXIME ACID
### A III 10/12/2001 EASTMAN CHEMICAL CO EASTMAN 168 PLASTICIZER
### A II 10/15/2001 QUIMICA SINTETICA SA LEVOFLOXACIN
### I II 10/22/2001 INDUSTRIA QUIMICA ANDINA Y CIA SA ACETYLSALICYLIC ACID
### I III 10/9/2001 BASELL GMBH LUPOLEN 5621 DX
### I III 10/9/2001 BASELL POLIOLEFINE ITALIA SPA LUPOLEN 5021 DX
### I II 10/19/2001 FARCHEMIA SRL RANITIDINE HYDROCHLORIDE
### A II 10/18/2001 LEK PHARMACEUTICALS DD LITHIUM CARBONATE A SUBSTANCE
### I III 10/22/2001 PENN COLOR INC 66W42 WHITE
### A II 10/18/2001 LIFE TECHNOLOGIES CORP POROS CHROMATOGRAPHIC RESINS
### I II 10/22/2001 APOTECNIA SA TERCONAZOLE
Page 506
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 10/15/2001 ADARE PHARMACEUTICALS SRL PANCRELIPASE PRODUCTS (EURAND MINITABS)
(HP55)
### A II 10/23/2001 INKE SA RISPERIDONE
### I II 10/24/2001 FINORGA SAS TMC 125
### A II 10/19/2001 POLYPEPTIDE LABORATORIES SWEDEN CALCITONIN (SALMON)
AB
### A III 10/23/2001 ASO CO LTD ASO CLEAN BAG, ASO CLEAN SHEET AND ASO
CLEAN TUBE
### I II 10/19/2001 SCINOPHARM TAIWAN LTD FLUTICASONE PROPIONATE
### A II 10/29/2001 OLON SPA MEFLOQUINE HYDROCHLORIDE
### I III 10/10/2001 BERRY PLASTICS CORP TAPES AND IS PAPER/POLYETHYLENE/FOIL/EMAA
COATINGS DIV TERPOLYMER
### A III 10/19/2001 POLYONE CORP CC00022659X1
### I II 10/22/2001 E BEGEROW GMBH AND CO BECODISK LENTICULAR CARTRIDGES
### A III 10/25/2001 MWV CALMAR GMBH ACCUPUMP SPRAY PUMP
### A II 10/31/2001 PERRIGO API LTD FLUMAZENIL
### A II 10/31/2001 CIPLA LTD TOPIRAMATE USP
### A II 10/29/2001 FINETECH PHARMACEUTICAL LTD DONEPEZIL HYDROCHLORIDE
### I III 4/24/2001 BESPAK INC ORAL ACTUATORS & CAPS
### A III 10/31/2001 RPC FORMATIC GMBH HANDIHALER DEVICE
### I III 10/22/2001 AMPACET CORP 7182288 WHITE POLYETHYLENE MASTERBATCH
Page 507
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 11/6/2001 KREBS BIOCHEMICALS AND PSEUDOEPHEDRINE HCL-USP
INDUSTRIES LTD
### I II 11/12/2001 DR REDDYS LABORATORIES LTD CLOPIDOGREL BISULFATE
### A III 11/5/2001 POLYONE CORP CC00000987WE
### A III 11/5/2001 POLYONE CORP CC00000985WE
### A III 11/5/2001 POLYONE CORP PRODUCT NUMBER 10016620
### A III 11/5/2001 POLYONE CORP CC00018782WE/60
### A II 11/13/2001 SANDOZ GMBH RAPAMYCIN
### A II 11/13/2001 SIGNA SA DE CV CLOPIDOGREL BISULPHATE USP
### I II 11/7/2001 SUN PHARMACEUTICAL INDUSTRIES SIMVASTATIN USP
LTD
### I III 11/15/2001 UCB FILMS, INC. BIAXIALLY ORIENTED POLYPROPYLENE (BOPP)
FILMS
### A II 11/15/2001 CIPLA LTD ONDANSETRON HCL USP
### I II 11/14/2001 SAFC BIOSCIENCES INC EX-CELL 302 MEDIUM (MODIFIED) CAT. #62630
### I II 11/16/2001 SUGAI CHEMICAL INDUSTRY CO LTD SMAP (BROMOSULFONE)
### A II 10/31/2001 SUN PHARMACEUTICAL INDUSTRIES TIZANIDINE HYDROCHLORIDE USP
LTD
### I II 11/14/2001 HETERO DRUGS LTD ITRACONAZOLE
### I II 11/15/2001 LONZA LTD CN25225 (METEXAFIN GADOLINIUM)
### I II 11/14/2001 HETERO DRUGS LTD TIZANIDINE HYDROCHLORIDE
### A II 11/14/2001 HETERO DRUGS LTD SERTRALINE HCL USP (FORM II PROCESS I)
### A II 11/15/2001 MYLAN LABORATORIES LTD NAPROXEN SODIUM USP
### I III 11/21/2001 HI TECH RUBBER INC MEDICAL COMPONENTS
### A II 11/19/2001 JM HUBER CORP CALCIUM CARBONATE
### I III 11/19/2001 TEKNOR COLOR CO 61,579HCPP MAROON 33:1
### A III 11/19/2001 TEKNOR COLOR CO 90,699 HCC WHITE 1%
### A II 11/21/2001 SIEGFRIED EVIONNAZ SA BETHANECHOL CHLORIDE
### A II 11/26/2001 TEVA PHARMACEUTICAL INDUSTRIES TORSEMIDE
LTD
### A II 11/12/2001 UNICHEM LABORATORIES LTD TIZANIDINE HCL USP
### I II 11/15/2001 LONZA AG CN 28091 LACTOL-LACTAM
### I III 10/29/2001 AMPACET CORP 7010778 AB POLYETHYLENE MASTERBATCH
### A II 11/12/2001 TEVA PHARMACEUTICAL INDUSTRIES FLUDARABINE PHOSPHATE
LTD
### I II 11/30/2001 BOEHRINGER INGELHEIM LTD ESMOLOL HCL
### I II 12/3/2001 SANOFI CHIMIE ZOPICLONE
### A II 11/29/2001 TEVA PHARMACEUTICAL INDUSTRIES FLUTICASONE PROPIONATE
LTD
### I II 12/3/2001 DR REDDYS LABORATORIES LTD AMLODIPINE MALEATE
### I III 11/27/2001 AMPACET CORP 11078-A WHITE ANTISTAT
### A II 12/3/2001 NORAC PHARMA HYDROUS BENZOYL PEROXIDE, USP
### A II 12/5/2001 MEDICHEM SA MIRTAZAPINE
### A II 12/6/2001 TARO PHARMACEUTICAL INDUSTRIES HYDROCORTISONE 17-BUTYRATE, USP
LTD
Page 508
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 12/7/2001 LOPAREX LLC WH FILM BASED 4400B SERIES COATED
RELEASE LINERS
### A II 12/5/2001 CAMBREX CHARLES CITY INC ONDANSETRON HCL
### I II 12/3/2001 KREBS BIOCHEMICALS AND L-EPHEDRINE HCL-USP
INDUSTRIES LTD
### I II 12/6/2001 DOTTIKON EXCLUSIVE SYNTHESIS AG DB5, IP-DB5
### I III 11/8/2001 AMCOR FLEXIBLES ITALIA SRL FLEXIBLE PACKAGING MATERIAL FOR DRUG
### A II 10/1/2001 BIDACHEM SPA RIBAVIRIN
### A II 12/5/2001 DR REDDYS LABORATORIES LTD FEXOFENADINE HYDROCHLORIDE
### A II 11/27/2001 PIRAMAL HEALTHCARE UK LTD CLOPROSTENOL SODIUM
### I II 12/11/2001 DIOSYNTH BV ESTRADIOL GLUCOSIDE
### I II 11/30/2001 MDS NORDION SA THALLOUS (T1-201) CHLORIDE
### I III 12/12/2001 BASELL USA INC PDC1273, PDC1274, PDC1284, PDC1287,
PDC1288, PRO-FAXPH433 AND PRO-FAXPH133
### I III 12/3/2001 CKS PACKAGING INC HIGH DENSITY POLYETHYLENE BOTTLES
### A III 12/5/2001 AMPACET CORP 10090 SLIP POLYETHYLENE MASTERBATCH
### I II 12/10/2001 DIXIE CHEMICAL CO INC TP1
### A III 11/23/2001 BPREX HEALTHCARE OFFRANVILLE SAS EYE-DROPPER SETS
Page 510
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I IV 1/14/2002 HANGZHOU NANHANG INDUSTRIAL POVIDONE USP
TRADE CO LTD
### I II 1/23/2002 LIPHA SAS HOMOTAURINE (CALCIUM ACAMPROSATE
INTERMEDIATE)
### A II 1/22/2002 TEVA PHARMACEUTICAL INDUSTRIES TIZANIDINE HYDROCHLORIDE USP
LTD
### A II 1/24/2002 USV PRIVATE LTD GLYBURIDE USP
### A II 1/23/2002 TARO PHARMACEUTICAL INDUSTRIES FLUCONAZOLE USP
LTD
### I II 1/24/2002 ESTEVE QUIMICA SA ADATANSERIN HYDROCHLORIDE (CRUDE)
### A II 1/24/2002 SANDOZ GMBH MYCOPHENOLIC ACID
### I IV 12/3/2001 DERIVADOS MACROQUIMICOS SA DE CV METHYL CELLULOSE
### A III 1/21/2002 SEALED AIR CORP CRYOVAC M916 MEDICAL CONNECTOR TUBING
### A III 1/23/2002 POLYONE CORP CC00018103WE
### A II 1/23/2002 IRVINE SCIENTIFIC SALES CO INC IS CHO-V(TM) (P)
### I II 1/28/2002 ANTIBIOTICOS SA 7-AMINO-DEACETOXY-CEPHALOSPORANIC ACID
(7ADCA)
### A III 1/23/2002 CORMACK PACKAGING PTY LTD THE CORMACK RING SEAL AND STANDARD
CLOSURES PLAIN OR LINED
### I II 1/30/2002 RHODIA USINE DE MULHOUSE PARATRIFLUOROMETHOXYANILINE
DORNACH
### A III 1/29/2002 NEMERA SERVICES MULTI DOSE POWDER INHALER (MDPI)
### A III 12/19/2001 LONSTROFF AG FLUOROELASTOMER RUBBER COMPOUND
F5028Q BLACK
### I IV 1/31/2002 CAPSUGEL INC EMPTY HARD CAPSULES FROM
HYDROXYPROPYLMETHYLCELLULOSE
(HYPROMELLOSE)
### I IV 1/31/2002 CAPSUGEL INC POLYSACCHARIDE EMPTY HARD CAPSULES
### I II 1/31/2002 SUMITOMO CHEMICAL CO LTD CITALOPRAM HYDROBROMIDE
### A II 1/31/2002 SPECGX LLC NALTREXONE METHOBROMIDE
### A II 1/29/2002 BIA SEPARATIONS DOO CIM CONVECTIVE INTERACTION MEDIA® DEAE
### A II 1/25/2002 HUBEI BIOCAUSE HEILEN IBUPROFEN USP
PHARMACEUTICAL CO LTD
### I II 1/31/2002 QUIMICA SINTETICA SA ZOLPIDEM TARTRATE
### A II 2/4/2002 SIGNA SA DE CV ALLOPURINOL USP
### I II 11/20/2001 CAMBREX CHARLES CITY INC DB5
### I III 1/23/2002 BLEN COLOR INC 16-03N AND 06-00 COLOR CONCENTRATES
### A III 2/5/2002 TAKETOMO INC ALUMINIUM FOR PRESS THROUGH PACKAGING
### I III 2/5/2002 GRAND POLYMER CO LTD GRAND POLYPRO J235T
### A II 2/6/2002 SRI KRISHNA PHARMACEUTICALS LTD ACETAMINOPHEN USP
### A II 2/4/2002 UNICHEM LABORATORIES LTD BENDROFLUMETHIAZIDE USP
### I II 1/31/2002 DIVIS LABORATORIES LTD 5-PHENYLHYDANTOIN
### A II 2/1/2002 IPCA LABORATORIES LTD PROPRANOLOL HYDROCHLORIDE USP
### A II 2/2/2002 IPCA LABORATORIES LTD METOPROLOL TARTRATE USP
Page 511
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 2/6/2002 MANTROSE HAEUSER CO INC CERTISEAL A-100
### A II 1/31/2002 MEISSNER FILTRATION PRODUCTS INC STERILUX AND STERIDYNE FILTER ELEMENTS
### I III 2/5/2002 COLORS FOR PLASTICS INC COLORS FOR PLASTICS I.D.: B 18854
### A III 2/12/2002 WACKER CHEMICAL CORP VINNOL® H 15/45 M
### I III 12/17/2002 COLORS FOR PLASTICS INC B20035
### A III 2/5/2002 QENOS PTY LTD ALKATHENE R LDJ225
### I III 5/24/2002 POLYTECH SOUTH INC MASTER BACHES
### I II 2/12/2002 CHEMI SPA SODIUM ALENDRONATE
### I II 2/12/2002 JUHUA GROUP CORP PHARMACEUTICAL IBUPROFEN
FACTORY
### I III 2/8/2002 PARYLENE COATING SERVICES INC PARYLENE COATING
### A IV 2/19/2002 WACKER CHEMIE AG SILFAR(R) SE 4
### A II 2/19/2002 TARO PHARMACEUTICAL INDUSTRIES DIFLORASONE DIACETATE USP MICRONIZED
LTD
### I II 2/18/2002 SIGMA ALDRICH CO LTD MEBROFENIN
### A II 2/15/2002 CIPLA LTD LEVOFLOXACIN HEMIHYDRATE USP
### A II 2/20/2002 TEVA PHARMACEUTICAL INDUSTRIES CARVEDILOL USP
LTD
### A II 2/18/2002 SERATEC SAS BETHANECHOL CHLORIDE USP
### I II 5/20/2002 TCI AMERICA BMIPP FINAL INTERMEDIATE
### I III 2/18/2002 ROLLPRINT PACKAGING PRODUCTS INC RPP#36-1085B
Page 513
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 3/28/2002 TEVA PHARMACEUTICALS INDUSTRIES SYNTHETIC CONJUGATED ESTROGENS,
LTD A(F00375)
### A IV 3/29/2002 DMV-FONTERRA EXCIPIENTS GMBH AND RESPITOSE SV 001 (DPI QUALITY)
CO KG
### A IV 3/29/2002 DMV-FONTERRA EXCIPIENTS GMBH AND PHARMATOSE 200 M (DPI QUALITY)
CO KG
### A II 3/29/2002 FLAMMA SPA MINOXIDIL
### A II 3/28/2002 SIEGFRIED EVIONNAZ SA ARTICAINE HYDROCHLORIDE
### I IV 4/2/2002 FMC CORP FMC BIOPOLYMER DIV LUSTRECLEAR(TM) LC 103 MICROCRYSTALLINE
CELLULOSE/CARRAGEENAN-BASED COATING
### A III 2/22/2002 BORMIOLI PHARMA SPA ENGRAVED SPOON + CE MARK
### I II 4/3/2002 LEK PHARMACEUTICALS DD PRAVASTATIN SODIUM
### A II 4/2/2002 SIEGFRIED LTD O-DESMETHYLVENLAFAXINE SUCCINATE
MONOHYDRATE
### A II 4/4/2002 TEVA PHARMACEUTICAL INDUSTRIES LAMOTRIGINE
LTD
### A II 4/4/2002 BAXTER PHARMACEUTICALS STERILE WATER FOR INJECTION FOR
SOLUTIONS LLC RECONSTITUTION
### A II 4/5/2002 ARCH PHARMALABS LTD MELOXICAM USP
### I III 4/4/2002 DSM RESEARCH STAMYLAN P PHC 27
### A IV 4/5/2002 LIPOID GMBH LIPOID E PG(EGG PHOSPHATIDYL GLYCEROL)
### I II 4/8/2002 GEDEON RICHTER PLC BUTOCONAZOLE NITRATE
### I III 4/3/2002 CLARIANT AUSTRALIA PTY LTD CUSTOM COLOR/ADDITIVE CONCENTRATES
FOR USE IN PLASTIC PRODUCTS AND
PACKAGING IN VICTORIA AND NSW, AUSTRALIA.
### A II 3/26/2002 LUPIN LTD CEFTRIAXONE SODIUM USP (STERILE )
### A II 4/10/2002 ERREGIERRE SPA RALOXIFENE HYDROCHLORIDE
### I II 3/18/2002 IVAX CR CABERGOLINE
### I II 4/11/2002 QUIMICA SINTETICA SA FOSINOPRIL SODIUM
### I II 4/15/2002 BAXTER PHARMACEUTICALS BACTERIOSTATIC WATER FOR INJECTION, USP
SOLUTIONS LLC
### A III 4/9/2002 DAK AMERICAS LLC B 95 A
### A II 4/16/2002 LIPOID GMBH LIPOID PURIFIED SOYBEAN OIL (PH. EUR. USP)
### A II 4/18/2002 STREM CHEMICALS INC CARBOPLATIN (USP)
### I II 4/18/2002 ASUBIO PHARMA CO LTD SUN N 8075 DRUG SUBSTANCE
### I II 4/17/2002 CODY LABORATORIES INC A WHOLLY PHENTERMINE HYDROCHLORIDE A INGREDIENT
OWNED SUBSIDIARY OF LANNETT CO
INC
### I III 3/11/2002 BASF AKTIENGESELLSCHAFT ULTRAFORM N2320 003 UNCOLORED
### A III 4/5/2002 POLYONE CORP CC00012334DR
### I II 4/10/2002 CUNO EUROPE SA ZETACARBON RX5S, SP AND SLP SERIES
### A II 4/17/2002 LIPOID GMBH LIPOID S VPC-3
### I II 4/18/2002 LABORATORIO CHIMICO ALLOPURINOL
INTERNAZIONALE SPA
### I II 4/22/2002 MITSUBISHI TANABE PHARMA CORP MCI-196 DRUG SUBSTANCE
Page 514
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 4/22/2002 LEK PHARMACEUTICAL AND CHEMICAL OMEPRAZOLE A DRUG SUBSTANCE
CO DD
### I II 4/4/2002 BOC MICRO APPLICATIONS CENTRE MICRO-CYLINDER PRESSURISED GAS CAPSULE
Page 518
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 8/2/2002 SAFC INC 2-METHYLENE-19-NOR-20-EPI-1 ,25-
DIHYDROXYVITAMIN D3
### I II 8/9/2002 PHARMACIA AND UPJOHN DIHYDROFLUOCINOLONE ACETONIDE
### I IV 8/6/2002 WILD FLAVORS INC NATURAL PEPPERMINT FLAVOR WONF
#FATEL649
### I IV 8/7/2002 FONA INTERNATIONAL INC #877.242 N-C MINT ROOTBEER FLAVOR,
NATURAL AND ARTIFICIAL
### A II 8/6/2002 HIKMA PHARMACEUTICALS HYDROCORTISONE USP
### A II 8/7/2002 DR REDDYS LABORATORIES LTD CLOPIDOGREL BISULFATE [FORM-I] USP
### I IV 8/6/2002 WILD FLAVORS INC NATURAL ORANGE FLAVOR #FATEB893
### I II 8/12/2002 ELAN DRUG DELIVERY INC N1177 NANOCRYSTAL(R) COLLOIDAL
DISPERSION
### A II 8/9/2002 LIPOID GMBH LIPOID FA 16:0
### I II 8/12/2002 BIOCON LTD SIMVASTATIN USP
### I II 8/12/2002 BIOCON INDIA LTD LOVASTATIN TECHNICAL(SFP)
### I V 8/5/2002 PATHEON UK LTD SWINDON STERILE MANUFACTURING AT SWINDON,
OPERATONS UNITED KINGDOM.
### I II 8/12/2002 FINE CHEMICALS CORP PTY LTD FLUPHENAZINE DECANOATE OIL(BMS)
### I II 8/19/2002 RANBAXY LABORATORIES LTD ATORVASTATIN CALCIUM(AMORPHOUS)
### A II 8/15/2002 PATHEON API MANUFACTURING INC A METYROSINE USP
PART OF THERMO FISHER SCIENTIFIC
### I III 7/10/2002 COLORS FOR PLASTICS INC B19558
### A III 8/20/2002 FORMOSA PLASTICS CORP USA FORMOLON PVC RESINS
### I II 8/19/2002 MALLINCKRODT INC HYDROCODONE ALKALOID
### I IV 8/21/2002 INGREDION INC UNIPURE(TM) DW
### A II 8/16/2002 NEULAND LABORATORIES LTD ALBUTEROL USP
### I II 8/21/2002 HEBEI ZHONGXING PHARMACEUTICAL 7-AMINOCEPHALOSPORANIC ACID
CO LTD
### I II 8/21/2002 SHIJIAZHUANG PHARMA GROUP HEBEI PENICILLIN G POTASSIUM
ZHONGRUN PHARMACEUTICAL CO LTD
### I III 8/15/2002 DUPONT PERFORMANCE COATINGS HERBERTS-1K-LF 190 X3
GMBH CO KG
### A II 8/21/2002 LUPIN LTD CEFUROXIME AXETIL (AMORPHOUS) USP
### A II 8/23/2002 CIPLA LTD LEFLUNOMIDE USP
16110 A II 8/22/2002 POLYPEPTIDE LABORATORIES INC THYMOSIN-ALPHA 1 DRUG SUBSTANCE
16111 I III 8/21/2002 AMPACET CORP 161367 USA INJ.DARK BLUE POLYPROPYLENE
MASTERBATCH
16112 A II 8/29/2002 ALEMBIC PHARMACEUTICALS LTD LEFLUNOMIDE USP
16113 A II 8/22/2002 SUN PHARMACEUTICAL INDUSTRIES MIRTAZAPINE USP [HEMIHYDRATE]
LTD
16114 I IV 8/26/2002 HISAMITSU PHARMACEUTICAL CO INC PIROTIODECANE (HPE-101)
16115 I II 8/29/2002 CQ INTERNATIONAL CO INC CAMPTOTHECIN
16116 A III 8/20/2002 APTAR FRANCE SAS APTAR EPDM ELASTOMER
Page 519
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
16117 A III 8/19/2002 GERRESHEIMER BOLESLAWIEC S A PLASTIC BOTTLES AND ACCESSORIES,
DROPPER BOTTLE SYSTEMS AND CONTAINERS
WITH CLOSURE SYSTEMS
16118 A II 8/23/2002 SCINOPHARM TAIWAN LTD DANTROLENE SODIUM USP
16119 A II 8/27/2002 WOCKHARDT LTD BETHANECHOL CHLORIDE USP
### A II 8/30/2002 MILLICENT HOLDINGS LTD ESTRADIOL 3 ACETATE
### I III 8/23/2002 CLARIANT CANADA INC BLUE CLARIANT MASTERBATCHES 04EHD-7206
### A II 9/4/2002 SEVEN STAR PHARMACEUTICAL CO LTD GUAIFENESIN USP
Page 520
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 9/5/2002 MALLADI DRUGS AND D-PSEUDOEPHEDRINE SULFATE
PHARMACEUTICALS LTD
### I II 9/26/2002 AMRI RENSSELAER INC PHENOBARBITAL SODIUM USP
### I IV 9/25/2002 INTERNATIONAL SPECIALTY PRODUCTS GANEX WP-660(VP/1-TRIANCONTENE
COPOLYMER)
### A II 9/24/2002 ACETO CORP LEVOCARNITINE USP
### A II 9/25/2002 TARO PHARMACEUTICAL INDUSTRIES GABAPENTIN USP
LTD
### A II 9/25/2002 SANOFI CHIMIE HYDROXOCOBALAMIN ACETATE
PH.EUR.,JP,PYROGEN-FREE
### I III 9/30/2002 WEST PENN PLASTIC INC INJECTION MOLDING USING THERMOPLASTICS,
COLORANTS, AND CHEMICAL ADDITIVES
### A III 9/24/2002 POLYONE CORP UV ABSORBER PRODUCT NUMBER
CC0003827960
### I IV 9/27/2002 THERMAX LTD CHEMICAL DIV TULSION(R) 335
### I III 10/1/2002 BESPAK INC ALBUTEROL ACTUATOR-CAP ASSEMBLY
### I III 9/25/2002 GRAHAM PACKAGING CO LP PLASTIC BOTTLES
### I II 9/30/2002 BECTON DICKINSON AND CO BD CELL MAB MEDIUM ANIMAL COMPONENT
FREE
### A III 9/20/2002 STERI-PLAS PTY LTD 35ML TABLET BOTTLE
### A III 9/23/2002 STERI-PLAS PTY LTD 55ML TABLET BOTTLE
### A III 9/23/2002 STERI-PLAS PTY LTD 45ML TABLET BOTTLE
### A III 9/23/2002 STERI-PLAS PTY LTD 20ML TABLET BOTTLE
### A III 9/24/2002 POLYONE CORP UV ABSORBER PRODUCT NUMBER
CC00003928WE
### I II 9/30/2002 BECTON DICKINSON AND CO BD CELL MAB MEDIUM SERUM-FREE
### I V 9/17/2002 STERIS ISOMEDIX SERVICES CONTRACT STERILIZATION FACILITY
### A II 10/1/2002 CAMBREX CHARLES CITY INC NICOTINE POLACRILEX, 15%, USP
### I II 10/2/2002 SAFC BIOSCIENCES INC EX-CELL(TM) 302 SERUM-FREE MEDIUM, W/O L-
GLUTAMINE
### I II 10/2/2002 SAFC BIOSCIENCES INC EX-CELL(TM) 620-HSF, HYBRIDOMA SERUM-
FREE MEDIUM, W/O L-GLUTAMINE
### A II 9/30/2002 INKE SA ONDANSETRON BASE
### A III 9/30/2002 NIPRO PHARMA PACKAGING FRANCE PACKAGING MATERIAL
### A II 9/24/2002 SUN PHARMACEUTICAL INDUSTRIES FLUVOXAMINE MALEATE USP
LTD
### A III 9/27/2002 TOKAI CHEMICAL INDUSTRY CO LTD PACKAGING MATERIALS
### A II 10/4/2002 CHATTEM CHEMICALS INC METHAMPHETAMINE HYDROCHLORIDE USP
### A V 9/26/2002 134A CONSORTIUM ACCEPTANCE TESTING OF HFA-134A(1,1,1,2-
TETRAFLUOROETHANE)
### A II 10/9/2002 SYNBIAS PHARMA LTD DOXORUBICIN HYDROCHLORIDE
### I II 9/18/2002 CHEMISCHE FABRIK BUDENHEIM KG DIBASIC SODIUM PHOSPHATE ANHYDROUS
### A II 10/8/2002 DR REDDYS LABORATORIES LTD SULINDAC USP
### I III 10/8/2002 RIWISA AG DRY POWDER INHALER
### A III 10/9/2002 SEALED AIR CORP UNIMARK WINGED SPIKE PORT
Page 521
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 10/14/2002 PEPTISYNTHA SA ATN 161 BULK DRUG SUBSTANCE
### I II 10/11/2002 MERCK SANTE SAS CRE 15876/A4 INTERMEDIATE
### I II 10/11/2002 MERCK SANTE SAS CRE 16257 DRUG SUBSTANCE
### A II 10/8/2002 IRVINE SCIENTIFIC SALES CO IS CHO-CD(TM) (L) CATALOG #91119
### A II 10/4/2002 UQUIFA MEXICO SA DE CV TERBINAFINE HYDROCHLORIDE
### A II 10/4/2002 UQUIFA MEXICO SA DE CV VENLAFAXINE HYDROCHLORIDE
### A II 10/4/2002 UNICHEM LABORATORIES LTD MELOXICAM USP
### A IV 10/15/2002 INGREDION INC UNIPURE(TM) DW-L, PREGELATINIZED CORN
STARCH NF PHEUR
### I II 9/24/2002 YANCHENG SUHAI PHARMACEUTICAL DOXYCYCLINE HYCLATE USP
CO LTD
### I II 9/26/2002 LONZA AG SB 200473
### A II 10/17/2002 DR REDDYS LABORATORIES LTD RAMIPRIL USP
### I II 10/17/2002 LEK PHARMACEUTICALS DD DIHYDROERGOTAMINE MESYLATE
### I III 10/17/2002 WIPF AG POLIALUVEL(R) STERIL OVERWRAP BAG
INTENDED FOR DRUG PACKAGING
### I III 8/27/2002 BASF SE ULTRADUR B 4500 NATURAL
### I III 10/9/2002 COLORS FOR PLASTICS INC E13210
### I III 10/9/2002 COLORS FOR PLASTICS INC E13211
### I III 10/9/2002 COLORS FOR PLASTICS INC S34508
### I II 10/22/2002 VERA LABORATORIES LTD NAPROXEN SODIUM
### A II 10/14/2002 OLON SPA KETOTIFEN HYDROGEN FUMARATE
### A III 1/6/2003 JAPAN VILENE CO LTD MEDICAL BACKING NON-WOVEN FABRIC: EW-
4350PE
### I II 10/18/2002 BANYU PHARMACEUTICAL CO LTD J-107088
### I II 10/22/2002 LEK PHARMACEUTICALS DD PRAVASTATIN SODIUM
### A II 10/22/2002 ZHEJIANG HISUN PHARMACEUTICAL CO CLADRIBINE USP
LTD
### I II 10/15/2002 ROHIT PLASTICS AND CHEMICALS CHLORHEXIDINE GLUCONATE 20%
### I II 10/25/2002 VERA LABORATORIES LTD TRAZODONE HYDROCHLORIDE
### A II 10/25/2002 ALEMBIC PHARMACEUTICALS LTD FENOFIBRATE USP
### I II 10/24/2002 PISGAH LABS INC BUTALBITAL USP
### A II 10/23/2002 ZHEJIANG KANGLE PHARMACEUTICAL ACETAMINOPHEN
CO LTD
16211 I III 9/27/2002 BASF AKTIENGESELLSCHAFT RONFALIN SCF 34 WHITE 30265
### A II 10/17/2002 UQUIFA MEXICO SA DE CV KETOCONAZOLE
### A IV 10/22/2002 DUPONT NUTRITION USA INC PROTANAL® SODIUM ALGINATE, NF
### I III 10/25/2002 BOREALIS AG PACKAGING MATERIAL FB2310
### A II 10/22/2002 ERREGIERRE SPA NISOLDIPINE
### A III 10/12/2002 PIRAMAL GLASS PRIVATE LTD GLASS CONTAINERS
### I II 10/21/2002 OLON SPA OXANDROLONE
### I II 10/30/2002 WOCKHARDT LTD CLARITHROMYCIN
### I III 10/25/2002 BOREALIS AG PACKAGING MATERIAL FB2230
### I III 7/22/2002 ALBIS PLASTIC GMBH LUPOLEN CONCENTRATE SL 02 EA
### I III 10/2/2002 AIR PRODUCTS AND CHEMICALS INC FLEXCRYL(R) AC20 EMULSION
Page 522
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 10/24/2002 SANKYO CO LTD CS-003 DRUG PRODUCT
### I II 10/24/2002 SANKYO CO LTD CS-003 DRUG SUBSTANCE
### I II 11/5/2002 CILAG AG DIVALPROEX SODIUM
### I II 11/5/2002 SUZHOU NUMBER 4 PHARMACEUTICAL CLINDAMYCIN PHOSPHATE USP
FACTORY
### I II 11/4/2002 TRAGARA PHARMACEUTICALS INC CS-706 DRUG SUBSTANCE
### I II 10/28/2002 IRVINE SCIENTIFIC SALES CO INC IS MAB-V(TM)
### A III 10/28/2002 POLYONE CORP COLORANT PRODUCT NO. CC0003821560
### I III 9/25/2002 BANGKOK POLYESTER PUBLIC CO LTD BANGKOK PET V080P
### I III 11/11/2002 GRAHAM PACKAGING CO LP PLASTIC BOTTLES
### A IV 11/4/2002 FERTIN PHARMA AS CHEWING GUM BASE: DAN MED 60 W/BHT
### A II 11/8/2002 3M PURIFICATION INC LIFEASSURE(TM) PFS SERIES AND
LIFEASSURE(TM) FP SERIES FILTER PRODUCTS
### I III 11/5/2002 ROHM AND HAAS CO LAMAL 408-40 AND LAMAL COREACTANT C
### I II 11/11/2002 NV ORGANON HEPARIN SODIUM III
### A II 11/5/2002 YANGZHOU PHARMACEUTICAL CO LTD ISONIAZID
### I II 11/7/2002 MITSUBISHI PHARMA CORP MT-210 BULK DRUG SUBSTANCE
### I II 11/6/2002 GILEAD SCIENCES INC LIPOSOMAL LURTOTECAN FOR INJECTION (OSI-
211)
### I II 11/6/2002 TRAGARA PHARMACEUTICALS INC CS-706 DRUG PRODUCT
### A III 11/11/2002 RPC FORMATIC GMBH M-71 MOUTHPIECE, MATERIAL NO.35155911
### A II 11/11/2002 ZHEJIANG HISUN PHARMACEUTICAL CO VINBLASTINE SULFATE USP
LTD
### I II 11/13/2002 SICOR SWISS BRANCH FORMOTEROL FUMARATE
### A II 11/13/2002 INDENA SPA PACLITAXEL P.I.
### A II 11/15/2002 DELMAR CHEMICALS INC MONTELUKAST SODIUM THIOL ACID
### A II 11/14/2002 WAVELENGTH ENTERPRISES LTD CETIRIZINE DIHYDROCHLORIDE
### A II 11/15/2002 PAR A TECHNOLOGIES PRIVATE LTD CLONAZEPAM
### I II 12/10/2002 MYLAN LABORATORIES LTD NAPROXEN USP
### I II 11/19/2002 ITF CHEMICAL LTDA PAROXETINE HYDROCHLORIDE HEMIHYDRATE
### I II 11/18/2002 PROMETIC BIOSCIENCES LTD MABSORBENT A1P
### I II 11/20/2002 SSP CO LTD SS734
### A II 11/19/2002 DIPHARMA FRANCIS SRL MODAFINIL USP
### A II 11/14/2002 UNION QUIMICO FARMACEUTICA SA RANITIDINE BASE
(UQUIFA SA)
### I III 11/14/2002 ROHM AND HAAS CO ROBOND PS-7619
### I II 11/18/2002 R N PHARMACEUTICALS CHLORHEXIDINE ACETATE
### I II 11/19/2002 SIEGFRIED LTD AMOROLFINE HYDROCHLORIDE
### A II 11/15/2002 ZHEJIANG HISUN PHARMACEUTICAL CO MESNA USP
LTD
### I II 1/2/2003 SA AJINOMOTO OMNICHEM NV BALSALAZIDE DISODIUM
### I IV 11/21/2002 NATIONAL STARCH AND CHEMICAL CO DRY-FLOC(R) PC AESTHETIC ENHANCER
### A II 10/31/2002 SYNBIAS PHARMA AG EPIRUBICIN HYDROCHLORIDE
### A II 11/20/2002 SUVEN LIFE SCIENCES LTD LAMOTRIGINE USP
Page 523
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 1/14/2003 NATUREX LTD TALIN ( THAUMATIN )
### I II 11/27/2002 SUN PHARMACEUTICAL INDUSTRIES QUINAPRIL HYDROCHLORIDE USP
LTD
### A II 11/27/2002 TARO PHARMACEUTICAL INDUSTRIES CETIRIZINE DIHYDROCHLORIDE USP
LTD
### A II 11/18/2002 UNICHEM LABORATORIES LTD METRONIDAZOLE USP
### A II 11/25/2002 FERMIC SA DE CV CLAVULANATE POTASSIUM+SILICON DIOXIDE
### A II 11/25/2002 FERMIC SA DE CV CLAVULANATE
POTASSIUM+MICROCRYSTALLINE CELLULOSE
### A III 11/20/2002 PRESSPART MANUFACTURING LTD STAINLESS STEEL AEROSOL CANISTERS
### A II 11/25/2002 WOCKHARDT LTD CEFUROXIME AXETIL(AMORPHOUS)
### I II 11/25/2002 WOCKHARDT LTD AZITHROMYCIN-FORM I
### I V 11/26/2002 NATIONAL INSTITUTES HEALTH CURRICULA VITAE (CV) FOR HIV PREVENTION
NATIONAL INSTITUTE ALLERGY TRIALS NETWORK (HPTN) INVESTIGATORS.
INFECTIOUS DISEASES
### I II 11/21/2002 SICOR SPA DOXORUBICIN HYDROCHLORIDE, LYOPHILIZED
### A II 11/26/2002 GADOR SA NORGESTIMATE- DEXNORGESTREL ACETIME
### I II 11/25/2002 KUNSHAN DOUBLE CRANE METFORMIN HYDROCHLORIDE
PHARMACEUTICAL CO LTD
### I II 11/25/2002 RELIABLE BIOPHARMACEUTICAL CORP HYALURONIDASE
### A III 11/18/2002 POLYONE CORP PRODUCT NO. CC00017894DR
### I III 11/15/2002 STE PACKAGING DEVELOPMENT SL PLASTIC MOLDED COMPONENTS FOR
PACKAGING AND DELIVERY OF
PHARMACEUTICAL PRODUCTS
### I III 11/19/2002 AMPACET CORP 12416 PEARL POLYPROPYLENE MASTERBATCH
### I III 11/12/2002 BESPAK DIV CONSORT MEDICAL PLC BK357951MT PHARMACEUTICAL METERING
VALVE
### A II 11/26/2002 UNICHEM LABORATORIES LTD HYDROCHLOROTHIAZIDE USP
### A II 12/2/2002 SMS PHARMACEUTICALS LTD SUMATRIPTAN SUCCINATE
### I II 12/2/2002 PLIVA-LACHEMA AS CARBOPLATIN
### A II 12/2/2002 TEVA PHARMACEUTICAL INDUSTRIES VENLAFAXINE HYDROCHLORIDE
LTD
### I III 3/5/2003 WINPAK TECHNOLOGIES INC PREPARATION OF PRE-FILLED SYRINGE
### A II 11/28/2002 AMINO CHEMICALS LTD TERBINAFINE HYDROCHLORIDE
### A IV 12/2/2002 DMV-FONTERRA EXCIPIENTS GMBH AND RESPITOSE ML002
CO KG
### A IV 12/2/2002 DMV-FONTERRA EXCIPIENTS GMBH AND RESPITOSE SV003
CO KG
### A II 12/4/2002 AKZO NOBEL CHEMICALS SA DE CV PERKADOX API (BENZOYL PEROXIDE)
### I II 12/4/2002 SUN PHARMACEUTICAL INDUSTRIES GABAPENTIN USP (NON-STERILE BULK)
LTD
### I II 12/6/2002 NV ORGANON ESTERIFIED ESTROGENS BA
### I II 12/5/2002 INTERQUIM SA ABAPERIDONE HYDROCHLORIDE
### A III 12/4/2002 RENOLIT HISPANIA SA RENOLIT PHARMAFOLIE ART.-GRUPPE 41
### A III 12/5/2002 INEOS STYROLUTION AMERICA LLC ZYLAR(R) RESINS
Page 524
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 12/10/2002 COLLGARD BIOPHARMACEUTICALS LTD HALOFUGINONE HYDROBROMIDE
### I III 11/27/2002 BASF SE ULTRAFORM W 2320 003 UNCOLORED Q600
### A III 12/6/2002 LOPAREX LLC RELEASE LINERS MADE WITH TIN CURE
CHEMISTRY ON POLYESTER FILM SUBSTRATES
### A III 12/6/2002 LOPAREX LLC KFT BASED 6300 SERIES COATED RELEASE
LINERS
### A III 12/6/2002 LOPAREX LLC RELEASE LINERS MADE WITH PLATINUM CURE
CHEMISTRY ON POLYESTER SUBSTRATES
### A II 12/2/2002 CADILA HEALTHCARE LTD FLUCONAZOLE USP
### I III 12/2/2002 BERRY PLASTICS CORP TAPES AND STERILE FINISHED PRODUCTS AND STERILE
COATINGS DIV PROCESSING OPERATION
### A II 12/10/2002 CSPC ZHONGNUO PHARMACEUTICAL 7-AMINOCEPHALOSPORANIC ACID 7-ACA
SHIJIAZHUANG CO LTD
### A II 12/11/2002 SUN PHARMACEUTICAL INDUSTRIES VALACYCLOVIR HYDROCHLORIDE USP
LTD (HYDROUS)
### A II 12/5/2002 ERREDUE SPA INNOVATIVE CHEMICAL PHENYTOIN SODIUM
AND LIFE
### I III 12/10/2002 STELLA KUNSTSTOFFTECHNIK GMBH SECRO PP28, CHILD-PROFF CLOSURE,
WHITE/YELLOW WITH SEALING DISK
### I III 12/2/2002 BERRY PLASTICS CORP TAPES AND STERILE FACILITY
COATINGS DIV
### I II 11/28/2002 POLFA TARCHOMIN SA ERYTHROMYCIN THIOCYANATE
### A II 12/11/2002 ZHEJIANG HISUN PHARMACEUTICAL CO SIMVASTATIN USP
LTD
### A II 12/12/2002 MYLAN LABORATORIES LTD MODAFINIL USP
### A V 12/12/2002 LILLY FRANCE SAS PROCEDURES FOR STERILE OPERATIONS
### I III 11/25/2002 BESPAK EUROPE LTD BK 357676MT PHARMACEUTICAL METERING
VALVE
### A II 12/13/2002 ZHEJIANG HISUN PHARMACEUTICAL CO PRAVASTATIN SODIUM USP
LTD
### A II 12/13/2002 TEVA PHARMACEUTICAL INDUSTRIES MODAFINIL
LTD
16311 I II 12/16/2002 MAPRIMED SA LOSARTAN POTASSIUM
### A II 12/11/2002 KATWIJK CHEMIE BV DIVALPROEX SODIUM
### I II 12/17/2002 SANDOZ PRIVATE LTD CEFIXIME
### A II 12/17/2002 TEVA PHARMACEUTICAL INDUSTRIES LABETALOL HYDROCHLORIDE
LTD
### I II 12/17/2002 RELIABLE BIOPHARMACEUTICAL CORP APROTININ
### A II 1/27/2003 DR REDDYS LABORATORIES LTD FLUCONAZOLE (FORM 2)
### A II 12/13/2002 INKE SA ONDANSETRON HYDROCHLORIDE
### A III 12/18/2002 IWATA GLASS INDUSTRIAL CO LTD DRUG AMPOULES AND VIALS
### A V 12/9/2002 PFIZER PERTH PTY LTD PERTH ASEPTIC ONCOLOGY MANUFACTURING
FACILITY IN WESTERN AUSTRALIA, AUSTRALIA.
### A II 1/29/2003 DR REDDYS LABORATORIES LTD ONDANSETRON
Page 525
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 12/17/2002 SUN PHARMACEUTICAL INDUSTRIES FOSINOPRIL SODIUM USP (NON-STERILE BULK)
LTD
### I III 12/18/2002 LORMAC INDUSTRIAL DISTRIBUTORS LORMAC 30 POLYETHYLENE BAGS
LTD
### A II 12/3/2002 SUN CHEMICAL CO LTD BENZYL (3S)-1,2,3,4-
TETRAHYDROISOQUINOLINE-3-CARBOXYLATE
P-TOLUENESULFONIC ACID SALT
### A II 12/18/2002 ZHEJIANG HISUN PHARMACEUTICAL CO EPIRUBICIN HYDROCHLORIDE
LTD
### I II 12/19/2002 FARMABIOS SPA CEFUROXIME SODIUM (INTERMEDIATE)
### I II 12/19/2002 PLIVA LACHEMA AS DACARBAZINE
### A II 12/23/2002 5N PLUS LUBECK GMBH BISMUTH SUBSALICYLATE SG
### I III 12/24/2002 PPG INDUSTRIES INC COVERING PPG2004855 COATING FOR
AEROSOL CANS CONTAINING DRUG PRODUCT
### I II 12/16/2002 SAFC INC HALOBETASOL PROPIONATE (HBS)
### A II 1/29/2003 DR REDDYS LABORATORIES LTD CARVEDILOL FORM-2
### A II 12/20/2002 CHATTEM CHEMICALS INC METHYLPHENIDATE HYDROCHLORIDE, USP
### I II 12/19/2002 DOTTIKON EXCLUSIVE SYNTHESIS AG T-3811A05
### I II 12/20/2002 HEUMANN PHARMA GMBH CARPROFEN
### A II 12/20/2002 HOVIONE FARMACIENCIA SA FLUTICASONE PROPIONATE
### I II 12/18/2002 OMNICHEM SA T-3811A15
### I II 12/17/2002 DAITO CORP FLAVOXATE HYDROCHLORIDE JP14
### A III 12/18/2002 BERRY GLOBAL PRODUCT 15807-55
### A III 12/18/2002 BERRY GLOBAL PRODUCT 60091-21
### A II 12/26/2002 TARO PHARMACEUTICAL INDUSTRIES OXCARBAZEPINE MICRONIZED
LTD
### I II 12/18/2002 LONZA AG CN 343 (SAS)
### A III 12/13/2002 POLYONE CORP PRODUCT NO. CC00017075WE
### I II 12/30/2002 PROCOS SPA GABAPENTIN
### I II 12/24/2002 SANYO FINE CO LTD HMMP
### A II 12/20/2002 CHEMPACIFIC CORP NOREPINEPHRINE BITARTRATE
### A II 12/20/2002 THE ANDHRA SUGARS LTD ASPIRIN USP
### I II 1/3/2003 DIOSYNTH BV ALTRENOGEST
### I II 1/3/2003 DIOSYNTH BV TRENBOLONE ACETATE
### I II 1/2/2003 WENZHOU PHARMACEUTICAL FACTORY ACETAMINOPHEN DC GRANULAR
### A IV 1/6/2003 SANYO CHEMICAL INDUSTRIES LTD POLYQUID PA-30 AND POLYQUID PA-30L
### I II 1/23/2003 OLON SPA CEFUROXIME AXETIL
### A II 12/6/2002 RHODES TECHNOLOGIES HYDROMORPHONE HYDROCHLORIDE USP
### A II 1/2/2003 ERREGIERRE SPA CICLOPIROX OLAMINE USP-PH.EUR.
### A II 12/30/2002 ERREGIERRE SPA CICLOPIROX USP-EP
### A III 1/6/2003 ADVANEX EUROPE LTD GSK MDI COUNTER WIRE FORMS
### I II 1/14/2003 NITTO DENKO CORP OLIGONUCLEOTIDE APQ
### I II 1/13/2003 SAFC BIOSCIENCES INC EX-CELL(TM) 302, SERUM-FREE MEDIUM, W/O L-
GLUTAMINE, W/O NAHCO3
Page 526
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 1/23/2003 CHONGQING CARELIFE CLINDAMYCIN PHOSPHATE USP
PHARMACEUTICAL CO LTD
### I II 1/10/2003 AVANTI POLAR LIPIDS INC NP-015-ANTHRAX IMMUNE GLOBULIN (HUMAN)
INTRAVENOUS
### I II 1/10/2003 AVANTI POLAR LIPIDS INC 1,2-DI-O-OCTADECENYL-3-(N,N-
DIEMTHYLAMINOPROPANE) (DODMA)
### A III 1/13/2003 MITSUBISHI GAS CHEMICAL CO INC OXYGEN ABSORBERS AGELESS S ZPT, ZP (ZPT-
C) SS AND ZM
### I II 1/15/2003 JOHNSON MATTHEY PHARMACEUTICAL 2-BUTYL-4-CHLORO-1-[[2'-[2-
MATERIALS (TRIPHENYLMETHYL)-2H-TETRAZOL-5-YL]-[1,1'-
BIPHENYL]-4-YL]METHYL]1-H-IMIDAZOLE-5-
METHANOL (TTL)
### I IV 1/16/2003 SPI PHARMA INC MANNOGEM(TM) EZ SPRAY DRIED MANNITOL
USP
### I III 1/15/2003 LORMAC INDUSTRIAL DISTRIBUTORS LORMAC 7-B POLYETHYLENE
LTD
### I III 1/16/2003 ALKERMES INC C2S DRY POWDER INHALER DRUG DELIVERY
SYSTEMS
### A III 1/16/2003 FORTEQ NIDAU AG MDI COUNTER PROJECT
### A IV 1/15/2003 KERRY CANADA INC BUBBLEGUM ARTIFICIAL FLAVOR 712563
### I II 1/17/2003 MEDICHEM SA ALENDRONATE SODIUM
### A III 1/21/2003 ZEON CORP CYCLOOLEFIN POLYMER
### A II 1/21/2003 SOLARA A PHARMA SCIENCES LTD ISRADIPINE, USP
### I II 1/16/2003 PHLOX PHARMACEUTICALS LTD CEFUROXIME ACID
### A II 1/20/2003 NEULAND LABORATORIES LTD ALBUTEROL SULFATE USP
### I II 1/17/2003 SYNTETICA FINE CHEMICALS INC AMONAFIDE L-MALATE
### I III 11/26/2002 BASF SE ULTRAFORM N 2320 003 UNCOLORED Q600
### A II 1/21/2003 PHYTON BIOTECH LLC SEMI-SYNTHETIC PACLITAXEL API
### I II 1/21/2003 HOVIONE FARMACIENCIA SA T-3811A15 (17TY01)
### I IV 1/2/2003 CI FARMACAPSULAS SA EMPTY HARD VEGETABLE CAPSULE SHELLS
### A III 1/21/2003 LANXESS CORP CHLOROBUTYL 1240
### I III 1/22/2003 ACI PLASTICS PACKAGING CLOSURE ARGUS-LOC TAMPERTEL CRC CLOSURES
SPECIALTY PRODUCTS
### A II 1/23/2003 ZHEJIANG JIUZHOU PHARMACEUTICAL SULFADIMETHOXINE SODIUM
CO LTD
### I II 1/16/2003 TIANJIN ZHONGAN PHARMACEUTICAL METRONIDAZOLE
CO LTD
### I II 1/22/2003 RANBAXY LABORATORIES LTD T-3811A 05
### I III 1/20/2003 OWENS ILLINOIS INC PLASTICS PACKAGING COMPONENTS
### I II 1/22/2003 EXPRESSION SYSTEMS LLC ESF 921 MEDIUM (A SERUM FREE
FORMULATION)
### I II 1/22/2003 EXPRESSION SYSTEMS LLC AF 99 MEDIUM (AN ANIMAL FREE FORMULATION)
### I III 1/24/2003 ASHLAND INC FLEXCRYL(R) SP-38 EMULSION
### I II 1/28/2003 SIGNA SA DE CV NEFAZODONE HYDROCHLORIDE
Page 527
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 1/24/2003 CURTEC NEDERLAND BV CLICK PACK'S 4500 SERIES AND KEGS 6900 AND
7000 SERIES
### A II 1/25/2003 EUTICALS SPA DESOGESTREL
### A II 1/30/2003 SANDOZ INDUSTRIAL PRODUCTS SA AZITHROMYCIN MONOHYDRATE (NON-STERILE
BULK)
### I II 11/26/2002 CADILA PHARMACEUTICALS LTD FLUCONAZOLE
### I III 1/27/2003 SOMAR CORP A MEDICAL BACKING CLOTH: SOMAPET HW-25
### I III 1/31/2003 BASF CORP ACRONAL(R) N-CR 112
### I III 1/15/2003 AMPACET CORP 111203 WHITE POLYETHYLENE MASTERBATCH
### A IV 1/23/2003 MANE INC SPEARMINT FLAVOR S.D. E_9822433
### I II 2/3/2003 LABORATORI DERIVATI ORGANICI SPA SODIUM HEPARIN
### I III 1/31/2003 INTERNATIONAL MEDICATION SYSTEMS EMPTY PREFILLED DISPOSABLE PIPETTE (PDP),
LTD D SERIES S: D1000, D 2500, D5000, AND D10K
### A III 1/31/2003 MITSUBISHI GAS CHEMICAL CO INC OXYGEN ABSORBERS AGELESS FX
### A II 2/3/2003 GEDEON RICHTER PLC NORELGESTROMIN USP
### I II 1/30/2003 ALKALOIDA CHEMICAL CO ZRT TOPIRAMATE
### A II 1/20/2003 BIOCON LTD MYCOPHENOLATE MOFETIL
### I II 1/20/2003 BIOCON LTD MYCOPHENOLIC ACID
### A III 2/5/2003 WACKER CHEMIE AG ELASTOSIL(R) R 409/70 MH
### A II 4/23/2003 MYLAN LABORATORIES LTD ALLOPURINOL USP
### I II 2/3/2003 ROHIT PLASTICS AND CHEMICALS CHLORHEXIDINE BASE
16411 I II 1/31/2003 GMT FINE CHEMCALS SA DACARBAZINE USP
### A III 2/4/2003 BAXTER HEALTHCARE CORP PRESS-IN BOTTLE ADAPTERS AND PRESS-IN
BOTTLE WELL ASSEMBLIES
### A III 2/4/2003 BAXTER HEALTHCARE CORP EXACTA-MED® ORAL LIQUID DISPENSER
### A II 2/7/2003 SENJU PHARMACEUTICAL CO LTD BROENAC SODIUM
### A III 1/29/2003 NOLATO JAYCARE LTD 22OZ AND 30OZ ROUND PACKERS
### I II 2/6/2003 TEVA PHARMACEUTICAL INDUSTRIES PAROXETINE HYDROCHLORIDE HEMIHYDRATE
LTD
### I II 2/6/2003 CHEMAGIS LTD MIDODRINE HYDROCHLORIDE
### A II 2/4/2003 FILTROX AG DEPTH FILTER SHEETS
### A II 1/29/2003 TEVA PHARMACEUTICAL INDUSTRIES BUPRENORPHINE HYDROCHLORIDE
LTD
### I II 2/10/2003 SIGNA SA DE CV FLUCONAZOLE
### I II 1/10/2003 MDS NORDION ALTROPANE(R) [123I]-E-IACFT INJECTION
### I II 2/10/2003 UNIV MISSOURI COLUMBIA HO-166 CHLORIDE (166 HOCL3)
RADIOCHEMICAL
Page 528
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 2/12/2003 STERLING SPA FLUTICASONE PROPIONATE
### I II 2/5/2003 BACHEM SA RESVERATROL
### A II 2/17/2003 PHARMAZELL GMBH BALSALAZIDE DISODIUM
### I III 2/14/2003 AMPHASTAR PHARMACEUTICALS INC PROCESSING FOR WASHING,
DEPYROGENAING, SILICONIZING, STERILIZING
AND PACKAGING OF STERILE STOPPERS
### A II 1/21/2003 CKD BIO CORP CLAVULANATE POTASSIUM
### A II 2/13/2003 INDUSTRIALE CHIMICA SRL PHENTOLAMINE MESILATE USP
### I IV 2/17/2003 LIPOID GMBH LIPOID TG 8:0/8:0/8:0 (TRICAPRYLIN)
### A II 3/11/2003 JUBILANT GENERICS LTD OXCARBAZEPINE USP
### I II 2/17/2003 SUN PHARMACEUTICAL INDUSTRIES MESALAMINE USP (5-AMINO SALICYLIC ACID)
LTD
### I II 2/17/2003 AMSA SPA TOLMETIN SODIUM
### I II 2/21/2003 ALKERMES INC AVINZA((R) (MORPHINE SULFATE EXTENDED-
RELEASE CAPSULES) 30MG, 45MG, 60MG, 75MG,
90MG AND 120MG
### A III 2/19/2003 JOE PIETRYKA INC DOSAGE CUPS
### I III 2/18/2003 ALVEO AG ALVEOLIT(R) TE POLYMER FOAMS
### I III 2/11/2003 ROLLPRINT PACKAGING PRODUCTS INC RPP#33-2023
### I II 2/10/2003 TAKASAGO INTERNATIONAL CORP STERILE FINISHED PRODUCTS AND STERILE
PROCESSING OPERATIONS LOCATED IN
AMEEPET AND DUNDIGAL, INDIA
### A II 2/19/2003 CORDEN PHARMA BOULDER INC PACLITAXEL DRUG SUBSTANCE
### A II 2/25/2003 CHEMWERTH INC ANAGRELIDE HYDROCHLORIDE MONOHYDRATE
Page 532
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 4/21/2003 AMPACET CORP LP-23443 WHITE POLYETHYLENE
MASTERBATCH
### A II 4/29/2003 SPECGX LLC DEXTROAMPHETAMINE BASE
### I III 5/1/2003 AIR PRODUCTS AND CHEMICALS INC FLEXCRYL SP65
### A II 6/18/2003 CATALENT MICRON TECHNOLOGIES INC CONTRACT MICRONIZATION FACILITY
### A III 4/25/2003 SILGAN PLASTICS CORP PLASTICS BOTTLES, JARS AND CONTAINERS
### I III 4/15/2004 ROHM AND HAAS CO ADCOTE 40-3E
### I III 5/1/2003 ASHLAND INC FLEXCRYL(R) AF2066
### I III 5/5/2003 INTELLIGENT DEVICES INC MED-IC(TM) ECM PACKAGE
### A III 4/30/2003 MOLD RITE PLASTICS LLC PACKAGING MATERIAL
### I II 4/30/2003 CHANGZHOU SIYAO MERCAPTOPURINE USP
PHARMACEUTICALS CO LTD
### I II 5/2/2003 NATIONAL INSTITUTES HEALTH CHARACTERIZATION OF AEDES ALBOPICTUS
NATIONAL INSTITUTE ALLERGY AND (C6/36) MOSQUITO CELL LINE
INFECTIOUS DISEASES
### A III 5/9/2003 BD MEDICAL - PHARMACEUTICAL BD STERIFILL(TM) SCF(TM) PLASTIC
SYSTEMS PREFILLABLE SYRINGE SYSTEM (CRYSTAL
CLEAR POLYMER)
### A II 5/7/2003 CHEMISCHE FABRIK BERG GMBH PROPYLTHIOURACIL USP
### A II 5/9/2003 NATIONAL INSTITUTES HEALTH COCAINE HYDROCHLORIDE INJECTABLES
NATIONAL INSTITUTE DRUG ABUSE
### I II 5/12/2003 SUN PHARMACEUTICAL INDUSTRIES ACITRETIN USP
LTD
### I IV 5/8/2003 BIOFAC AS SPLEEN EXTRACT
### A II 5/12/2003 CHEMWERTH INC FENOLDOPAM MESYLATE (NON-STERILE BULK
DRUG SUBSTANCE)
### I II 5/12/2003 GW PHARMA LTD CANNABIS BASED MEDICINE
### I III 5/13/2003 LORMAC INDUSTRIAL DISTRIBUTORS LORMAC 1-E POLYETHYLENE BAGS
LTD
### I III 5/13/2003 LORMAC INDUSTRIAL DISTRIBUTORS LORMAC 1-B ANTI-STATIC POLYETHYLENE
LTD BAGS
### I II 5/14/2003 R N PHARMACEUTICALS CHLORHEXIDINE HCL
### I II 5/14/2003 MASTAFA NEVZAT ILAC SANAYII SULBACTAM SODIUM (NON-STERILE)
### A II 5/15/2003 EUTICALS SPA OXCARBAZEPINE
### A II 5/13/2003 EUTICALS SPA SUCRALFATE
### I III 5/9/2003 DYNIC USA CORP HT8 INK-THERMAL TRANSFER RIBBON
### A III 5/9/2003 DYNIC USA CORP HT8 PLUS INK-THERMAL TRANSFER RIBBON
### A III 4/17/2003 DYNIC USA CORP S245 INK-THERMAL TRANSFER RIBBON
### I II 5/13/2003 ISP CHEMICALS INC PHENOXYBENZAMINE HYDROCHLORIDE (PBZA)
### A II 5/14/2003 DR REDDYS LABORATORIES LTD ROSIGLITAZONE MALEATE USP (FORM III)
### A IV 5/8/2003 UNGERER AND CO LEMON SPRAY DRIED FLAVOURING V3938-1N1
### I II 5/19/2003 MATRIX LABORATORIES LTD AMLODIPINE
### A II 5/15/2003 FIS FABBRICA ITALIANA SINTETICI SPA OXCARBAZEPINE
### A II 5/22/2003 CEDARBURG PHARMACEUTICALS INC OXANDROLONE USP
Page 533
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 5/13/2003 UNGERER AND CO NATURAL & ARTIFICIAL CHERRY FLVP FL-8568
### A III 5/16/2003 POLYONE CORP BL22995, BLUE POLYPROPYLENE
CONCENTRATE
### A II 5/21/2003 PCAS APRACLONIDINE HYDROCHLORIDE
### I II 5/20/2003 AVANTI POLAR LIPIDS INC (+)-N-(2-HYDROXYEHTYL-N,N-DIMETHYL-2,3-
BIS(TETRADECYLOXY)-1-PROPANIMINIUM
BROMIDE (DMRIE-BR)
### I II 5/15/2003 MEDICARB AB CHITOSAN
### A II 5/22/2003 TEVA PHARMACEUTICAL INDUSTRIES RISEDRONATE SODIUM
LTD
### A II 5/26/2003 PIRAMAL ENTERPRISES LTD VERAPAMIL HYDROCHLORIDE
### A II 5/21/2003 DYNAMIT NOBEL GMBH CICLESONIDE
EXPLOSIVSTOFF UND SYSTEMTECHNIK
### I III 5/28/2003 RICON COLORS INC BLACK, CPP-BK853-1 RAW MATERIAL FOR
PACKAGING (CAPS)
### A II 6/2/2003 AVANTI POLAR LIPIDS INC L-THREO-DIHYDROSPHINGOSINE (SAFINGOL)
### A II 6/2/2003 AVANTI POLAR LIPIDS INC 1,2-DIOLEOYL-3-TRIMETHYLAMMONIUM
PROPANE (CHLORIDE SALT) (DOTAP•CL)
(770890)
### A II 5/20/2003 CAMBREX CHARLES CITY INC METHYLPHENIDATE HYDROCHLORIDE (RITALIN
HCL)
16611 I III 5/23/2003 PLASPAK CLOSURES PTY LTD STERILE PRODUCT OPERATION-NORTH (SPO-
NORTH)
### A III 5/12/2003 ALBEA TUBES FRANCE SAS HIGH DENSITY POLYETHYLENE
(HDPE)/ETHYLENE-VINLY- ALCOHOL (EVOH)
COPOLYMER/HDPE TUBES WITH
POLYPROPYLENE (PP) CAPS
### I II 5/19/2003 ZHEJIANG HUAHAI PHARMACEUTICAL PAROXETINE BASE (BULK)
CO LTD
### A II 5/22/2003 PHOSPHOLIPID GMBH PHOSPHOLIPON 90 G (1,2-DIACYL-SN-GLYCERO-
3-PHOSPHOCHOLINE)
### I II 5/30/2003 POLYPEPTIDE LABS INC KL4 ACETATE (SINAPULTIDE)
### I II 5/29/2003 YUHAN CHEMICAL INC LEVOFLOXACIN HEMIHYDRATE
### I II 5/19/2003 SHASUN CHEMICALS AND DRUGS LTD ROFECOXIB
### I III 6/2/2003 AMPACET CORP 111150 WHITE POLYETHYLENE MASTERBATCH
### I II 6/5/2003 AVON ORGANICS LTD EPHEDRINE HYDROCHLORIDE USP
### I III 5/28/2003 CLARIANT PRODUCTION FRANCE DESICCATOR WASHER IN PE
### A II 6/19/2003 MOEHS IBERICA SL METOPROLOL SUCCINATE
### I II 5/30/2003 SERAVAC BIOTECH PTY LTD HYALURONIDASE
### A II 6/3/2003 ABX ADVANCED BIOCHEMICAL TATM
COMPOUNDS GMBH
### I II 6/2/2003 ZENTIVA KS ZOLPIDEM TARTRATE
### A II 6/6/2003 GRANULES INDIA LTD METFORMIN HYDROCHLORIDE USP
### I III 6/9/2003 TEKNOR COLOR CO 18054 SLIP COLOR CONCENTRATE
### A III 6/9/2003 TEKNOR COLOR CO 93,947CP WHITE 2% COLOR CONCENTRATE
Page 534
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 6/3/2003 INKE SA FORMOTEROL FUMARATE
### I IV 5/27/2003 MCCORMICK AND CO INC FLAVOR FORMULAS
### I IV 6/11/2003 VSP TECHNOLOGIES INC ZYTREL(TM)
### I II 6/10/2003 AVECIA BIOTECHNOLOGY INC OLIGONUCLEOTIDE APH
### A II 6/12/2003 FDC LTD FLUCONAZOLE
### A III 6/12/2003 EMMAUS MEDICAL INC ORAL GLUTAMINE PACKETS
### I II 6/12/2003 ELAN DRUG DELIVERY INC N1406 (AGI-1067) NANOCRYSTAL(R) WHITE
TABLETS, 150 MG
### A II 6/11/2003 BIOCON LTD PIOGLITAZONE HYDROCHLORIDE USP
### A II 6/12/2003 CIPLA LTD ESCITALOPRAM OXALATE
### I II 6/12/2003 FH FAULDING AND CO LTD COATED PARACETAMOL POWDER
### I II 6/6/2003 ARCHIMICA SRL BENZOCAINE USP-EP
### A II 6/12/2003 EMMAUS MEDICAL INC GLUTAMINE PACKETS (ORAL)
### I III 5/23/2003 BASF AKTIENGESELLSCHAFT ULTRAFORM H4320 UNCOLORED
### A II 6/4/2003 ASH STEVENS INC DIMETHANDROLONE UNDECANOATE (CDB-
4521C)
### I III 6/6/2003 CLARIANT CANADA INC BROWN CLARIANT MASTERBATCH 06MPG-580
### I V 6/12/2003 SANTEN OY STERILIZATION PROCESS FOR CONTINUOUS
MOTION (CM1) COMPOUNDING AND FILLING
LINE
### A II 6/11/2003 TEVA PHARMACEUTICAL INDUSTRIES ONDANSETRON BASE
LTD
### A II 6/15/2003 WAVELENGTH ENTERPRISES LTD CILOSTAZOL
### I IV 6/10/2003 NATIONAL STARCH AND CHEMICAL CO UNI-PURE(TM) LQ
### A II 6/10/2003 NEULAND LABORATORIES LTD RAMIPRIL USP
### A II 6/16/2003 STERLING SPA MOMETASONE FUROATE
### I II 6/16/2003 WOCKHARDT LTD CEFUROXIME SODIUM (STERILE)
### A II 6/16/2003 WOCKHARDT LTD STERILE CEFTRIAXONE SODIUM USP
### I III 6/18/2003 MARUTANI CHEMICAL PLANT MK SETCAP
ENGINEERING CO LTD
### A III 6/20/2003 CCC PLASTICS CALCIUM STEARATE MB355-22 POLYETHYLENE
ADDITIVE CONCENTRATE
### I II 6/16/2003 MYTHEN SPA DEFEROXAMINE MESYLATE
### A III 6/9/2003 BESPAK DIV CONSORT MEDICAL PLC BESPAK BK690 DISKUS
### A III 6/23/2003 LANXESS CORP BUNA EP T 2450
### I II 6/18/2003 ORCHID CHEMICALS AND CEFUROXIME ACID
PHARMACEUTICALS LTD
### I II 6/19/2003 ESTEVE QUIMICA SA PANTOPRAZOLE SODIUM
### A II 6/24/2003 DR REDDYS LABORATORIES LTD LEVOFLOXACIN HEMIHYDRATE USP
### A II 6/19/2003 HIKMA PHARMACEUTICALS CORTISONE ACETATE, USP (MICRONIZED)
### A III 6/4/2003 COLORTECH INC 11004-18 WHITE POLYETHYLENE CONCENTRATE
Page 536
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 7/8/2003 TEVA PHARMACEUTICAL INDUSTRIES PACLITAXEL
LTD
### I V 6/26/2003 MERCK RESEARCH LABORATORIES L-829165 POSITRON EMISSION TOMOGRAPHY
(PET) TRACER SAFETY AND PHARMACOLOGY
REFERENCE DATA
### I II 7/14/2003 DISHMAN PHARMACEUTICALS AND EPROSARTAN MESYLATE
CHEMICALS LTD
### I IV 7/11/2003 FLAVORMATIC INDUSTRIES INC N&A GRAPE FLAVOR #909-510
### I IV 7/10/2003 FLAVORMATIC INDUSTRIES INC N&A BUBBLE GUM FLAVOR #909-487
### I II 7/14/2003 ERIOCHEM SA VINORELBINE TARTRATE, USP
### A II 7/7/2003 IPCA LABORATORIES LTD HYDROCHLOROTHIAZIDE USP
### I II 7/16/2003 MYLAN LABORATORIES LTD CLARITHROMYCIN USP (CXP)
### I II 7/15/2003 INSTITUTE DRUG TECHNOLOGY CARBOPLATIN
AUSTRALIA LTD
### A II 7/15/2003 HIKAL LTD ONDANSETRON HYDROCHLORIDE USP
16711 I III 7/10/2003 RICON COLORS INC WHITE CPP-W368-8 POLYPROPYLENE
### A III 7/16/2003 TUBEX TUBENFABRIK WOLFSBERG COLLAPSIBLE ALUMINIUM TUBES
GMBH
### A II 7/18/2003 USV PRIVATE LTD GLIMEPIRIDE USP
### I IV 7/18/2003 PADDOCK LABORATORIES INC DERMABASE(TM) CREAM
### I II 7/23/2003 DEGUSSA LTD INSOLUBLE PRUSSIAN BLUE [IRON (III)
HEXACYANOFERRATE (II)]
### A III 7/22/2003 APTAR RADOLFZELL GMBH MULTIDOSE DISPENSING SYSTEM FOR
UNPRESERVED PRODUCTS
### I II 7/21/2003 FABBRICA ITALIANA SINTETICI SPA CITALOPRAM
### I II 7/18/2003 GMT FINE CHEMCALS SA LEUCOVORIN CALCIUM, USP
### I IV 7/16/2003 FONA INTERNATIONAL INC #913.006, NAT & ART SPEARMINT FLAVOR
### A IV 7/24/2003 ROBERTET FLAVORS INC ARTIFICIAL SPRAY DRIED SUGAR TASTE
FLAVOR NV-24,013
### I IV 7/22/2003 FLAVORMATIC INDUSTRIES INC N&A APPLE FLAVOR #909-359
### A II 7/24/2003 TEVA PHARMACEUTICAL INDUSTRIES CILOSTAZOL USP
LTD
### I II 7/28/2003 DAIICHI SANKYO CO LTD DX-619 DRUG SUBSTANCE
### I IV 7/21/2003 SYMRISE INC ARTIFICIAL APPLE FLAVOR 9/70X834 (609041)
AND ARTIFICIAL WATERMELON FLAVOR 9/710233
(843657)
### A II 7/29/2003 AVANTI POLAR LIPIDS INC 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-
PHOSPHOCHOLINE (POPC)
### I III 7/9/2003 HUHTAMAKI RONSBERG TUBE LAMINATES 1327 F, 1337 F, 1338 F AND
2328 F
### A III 7/25/2003 CRESTANI SRL GLASS AMPOULES
### I II 7/23/2003 SPRING WIND HERBS INC ARNEBIA INDIGO JADE AND PEARL (AIJP)
OINTMENT
### A III 7/28/2003 BPREX HEALTHCARE OFFRANVILLE SAS PILL JARS SETS
Page 537
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 7/29/2003 UNIQUE CHEMICALS (A DIV OF J B NIFEDIPINE USP
CHEMICALS AND PHARMACEUTICALS
LTD)
### I III 7/10/2003 VALOIS SAS VALOIS BUTYL 540 SERIES ELASTOMER
### I II 8/1/2003 NORAMCO INC OXYCODONE BASE DRUG SUBSTANCE
### I II 7/31/2003 MERCK SHARP AND DOHME RESEARCH L-000825058
LABORATORIES DIV MERCK AND CO INC
Page 543
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 11/6/2003 TEVA PHARMACEUTICAL INDUSTRIES HALOBETASOL PROPIONATE
LTD
### A III 11/6/2003 SILGAN PLASTICS CORP INJECTION MOLDED PLASTIC FITMENTS- PARTS
AND CLOSURES-LINED AND
UNLINED/LINERLESS WITH AND WITHOUT
PRINTING
### A II 11/7/2003 BASF SE POLYETHYLENE GLYCOLS
### A II 11/7/2003 TEVA PHARMACEUTICAL INDUSTRIES DESMOPRESSIN ACETATE USP
LTD
### I II 11/7/2003 SF CHEM 3-CHLOROMETHYL-1,2,4-TRIAZOLIN-5-ONE
(CMT)
### A II 11/10/2003 OLON SPA HALOPERIDOL DECANOATE
### A II 11/14/2003 DSM SINOCHEM PHARMACEUTICALS AMOXICILLIN TRIHYDRATE (PURIMOX®)
NETHERLANDS BV
### A II 11/3/2003 UNION QUIMICO FARMACEUTICA SA NIMODIPINE (MICRONIZED)
(UQUIFA SA)
### A II 11/11/2003 JOHNSON MATTHEY INC OXALIPLATIN
### A II 11/13/2003 HOVIONE FARMACIENCIA SA HALOBETASOL PROPIONATE
### A III 10/16/2003 WIPAK OY INFUKING 200
### A III 11/10/2003 LOPAREX LLC CL FILM BASED 7.3K SERIES COATED RELEASE
LINERS
### I III 9/1/2003 PROENFAR SA PACKAGING MATERIAL
### I IV 11/3/2003 SYMRISE INC 815485 NATURAL CHAI SPICE FLAVOR
CONCENTRATE
### A II 11/14/2003 TEVA PHARMACEUTICAL INDUSTRIES CALCIPOTRIENE USP
LTD
### A III 11/14/2003 BD MEDICAL - PHARMACEUTICAL BD MONOVIAL(TM) SPIKE
SYSTEMS
### A II 11/14/2003 MEDTRONIC VASCULAR HOLDINGS ZOTAROLIMUS
UNLTD CO
### A II 11/18/2003 MYLAN LABORATORIES LTD CITALOPRAM HYDROBROMIDE USP
### A II 11/17/2003 ZAKLADY FARMACEUTYCZNE SODIUM ALENDRONATE
POLPHARMA SA
### A II 11/17/2003 CIPLA LTD RISPERIDONE USP
### I IV 11/18/2003 CAPSUGEL INC EMPTY HARD CAPSULES FROM
HYDROXYPROPYLMETHYLCELLULOSE
(HYPROMELLOSE)
### I II 11/17/2003 TEVA GROUP GATIFLOXACIN
### A II 11/17/2003 DR REDDYS LABORATORIES LTD LEVETIRACETAM
### A II 11/17/2003 VIFOR INTERNATIONAL INC VIT-45 POWDER
### I II 11/19/2003 RANBAXY LABORATORIES LTD 7-AMINO-3-[(Z)-PROPEN-1-YL]-3-CEPHEM-4-
CARBOXYLIC ACID (7-APCA)
### I II 11/12/2003 AMSA ANONIMA MATERIE SINTETICHE ANAGRELIDE HYDROCHLORIDE
AND AFFINI SPA
### I II 11/18/2003 CADILA HEALTHCARE LTD LORATADINE
Page 544
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 11/17/2003 ANONIMA MATERIE SINTETICHE AND FENOFIBRATE
AFFINI (AMSA) SPA
### A II 11/13/2003 AMSA ANONIMA MATERIE SINTETICHE GLYCOPYRROLATE
AND AFFINI SPA
### I II 11/21/2003 SUN PHARMACEUTICAL INDUSTRIES CEFPROZIL USP (NON-STERILE BULK)
LTD
### A II 11/20/2003 CATALENT PHARMA SOLUTIONS LLC CALCITRIOL 0.25 MCG SOFT GELATIN
CAPSULES
### I II 11/20/2003 KYOWA HAKKO KOGYO CO LTD PRAVASTATIN SODIUM
### A II 11/25/2003 TARO PHARMACEUTICAL INDUSTRIES ONDANSETRON HYDROCHLORIDE USP
LTD
### A II 11/21/2003 CHENG FONG CHEMICAL CO LTD PSEUDOEPHEDRINE HYDROCHLORIDE
### A II 11/19/2003 CATALENT PHARMA SOLUTIONS LLC RISPERIDONE 0.5 MG AND 1.0 MG ORALLY
DISINTEGRATING TABLETS
### I II 11/25/2003 WOCKHARDT LTD CITALOPRAM HYDROBROMIDE
### I II 11/25/2003 SUN PHARMACEUTICAL INDUSTRIES CLORAZEPATE DIPOTASSIUM USP
LTD
### I IV 11/24/2003 SYMRISE INC CONTRACT STERILIZATION FACILITY IN EL
PASO,TX
### I III 11/17/2003 AMPACET CORP 100991-K PROFLOW 91 POLYETHYLENE
MASTERBATCH
### A II 11/26/2003 DR REDDYS LABORATORIES LTD GLIMEPIRIDE USP
### A II 11/25/2003 BIORESPONSE LLC BIORESPONSE-DIINOLYLMETHANE (PG) (SPRAY
DRIED DIINDOLYLMETHANE) AND
BIORESPONSE-DIM (PG) CAPSULES (75 MG
DIINDOLYLMETHANE)
### I II 11/26/2003 HAUSER CHEMICAL RESEARCH INC EPIGALLOCATECHIN GALLATE (EGCG)
### I III 11/14/2003 ERIE MOLDED PLASTICS INC DISPENSING PLUG WITH A .178 ORIFICE THAT IS
USED ON A BOTTLE FOR DISPENSING LIQUID
MEDICINE
### A II 11/14/2003 NOF CORP POPC (FN) (1-PALMITOYL-2-OLEOYL
PHOSPHATIDYLCHOLINE)
### A II 11/14/2003 NOF CORP POPC(ST) (1-PALMITOYL-2-OLEOYL
PHOSPHATIDYLCHOLINE)
### A III 10/17/2003 BERRY GLOBAL 105.1T POLYETHYLENE SHEETING FILM
### I III 11/20/2003 BERRY PLASTICS CORP TAPES AND STERILE ELASTOMERIC CLOSURE AND ITEMS
COATINGS DIV
### I III 11/19/2003 CLARIANT CANADA INC WHITE CLARIANT MASTERBATCH 10EHD-196A
### A II 11/17/2003 EXCELLA GMBH AND CO KG GANCICLOVIR SODIUM
### A II 12/1/2003 AUROBINDO PHARMA LTD METFORMIN HYDROCHLORIDE USP
### I III 11/26/2003 LAJOVIC TUBA EMBALAZA DD INJECTION BLOW MOLDED PLASTIC BOTTLES
### A II 12/3/2003 TEVA PHARMACEUTICAL INDUSTRIES TOLTERODINE TARTRATE
LTD
### A II 12/3/2003 TEVA PHARMACEUTICAL INDUSTRIES LOSARTAN POTASSIUM
LTD
Page 545
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 10/30/2003 BACHEM AG HISTRELIN ACETATE
### A II 12/1/2003 INTERPHARMA PRAHA AS DIINDOLYLMETHANE (DIM)
### A II 12/2/2003 DR REDDYS LABORATORIES LTD MOXIFLOXACIN HYDROCHLORIDE USP
### I II 12/3/2003 MYLAN LABORATORIES LTD MOXIFLOXACIN HYDROCHLORIDE
### A II 12/1/2003 OLON SPA ACITRETIN
### I II 12/3/2003 CADILA HEALTHCARE LTD GATIFLOXACIN ANHYDROUS
### I II 12/1/2003 ALCHEM INTERNATIONAL LTD COLCHICINE USP
### A II 12/8/2003 HENGSHUI JIHENG PHARMACEUTICAL FOLIC ACID
CO LTD
### I II 12/8/2003 HENGSHUI JIHENG PHARMACEUTICAL ACETAMINOPHEN
CO LTD
### I II 12/8/2003 HENGSHUI JIHENG PHARMACEUTICAL METAMIZOLE SODIUM
CO LTD
### A II 12/1/2003 PCAS CICLOPIROX
### A II 12/5/2003 TEVA PHARMACEUTICAL INDUSTRIES BICALUTAMIDE
LTD
### A II 12/5/2003 TEVA PHARMACEUTICAL INDUSTRIES CLOPIDOGREL BISULFATE USP
LTD
### I II 2/28/2005 ITF CHEMICAL LTDA AZITHROMYCIN MONOHYDRATE
17011 I IV 11/24/2003 SYMRISE INC 826506 ENTRAPPED NATURAL & ARTIFICIAL
CHERRY FLAVOR
### A II 12/2/2003 DR REDDYS LABORATORIES LTD GATIFLOXACIN ANHYDROUS
### A II 12/10/2003 MYLAN LABORATORIES LTD GATIFLOXACIN
### I II 12/9/2003 DR REDDYS LABORATORIES LTD LANSOPRAZOLE FORM-1
### I II 12/1/2003 BASF CORP GLUCOPONA(R) 600 UP
### A II 11/26/2003 TIANJIN TIANYAO PHARMACEUTICALS BETAMETHASONE USP
CO LTD
### A V 12/11/2003 WEST PHARMACEUTICAL SERVICES INC WESTAR® RS PROCESS
Page 551
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 2/27/2004 TEKNOR COLOR CO COLOR CONCENTRATE 55,275CP GREEN 2%
AND ITS COMPOSITION
### I III 2/27/2004 TEKNOR COLOR CO COLOR CONCENTRATE 45,703CP BLUE 2% AND
ITS COMPOSITION
### I III 2/27/2004 TEKNOR COLOR CO COLOR CONCENTRATE 65,843CP RED 2% AND
ITS COMPOSITION
### I III 2/19/2004 AMPACET CORP 171083 TRANS MINT GREEN POLYPROPYLENE
MASTERBATCH
### I IV 2/18/2004 EMERSON RESOURCES INC MARCOAT 125
### I IV 2/18/2004 EMERSON RESOURCES INC MARCOAT 125N
### A III 12/23/2003 BORMIOLI PHARMA SPA CHILD-PROOF CAP 18 MM
### I IV 3/5/2004 CAPSUGEL INC POLYSACCHARIDE EMPTY HARD CAPSULES
17211 I II 3/4/2004 MYLAN LABORATORIES LTD AMLODIPINE BESYLATE USP (ADP)
### I III 2/24/2004 HB FULLER CO HL0916SUV
### A IV 3/1/2004 DDP SPECIALTY ELECTRONIC DOW CORNING™ ST- ELASTOMER 10
MATERIALS US 9 LLC
### I II 3/30/2004 SIGMA ALDRICH CO CHO ANIMAL-FREE MEDIUM MODIFICATION 21
### A II 3/4/2004 IRVINE SCIENTIFIC SALES CO IS CHO-CD4(TM) A CELL CULTURE MEDIUM
### A II 3/4/2004 IRVINE SCIENTIFIC SALES CO IS CHO-CD4(TM) POWDER A CELL CULTURE
MEDIUM
### I II 3/5/2004 AUROBINDO PHARMA LTD AMIODARONE HYDROCHLORIDE
### I II 3/4/2004 CHEMWERTH INC DAUNORUBICIN HYDROCHLORIDE (TECHNICAL
GRADE)
### A III 3/8/2004 3M DRUG DELIVERY SYSTEMS SCOTCHPAK™ 9730
### I III 3/4/2004 HUMPHREY COSBURN PLASTICS FLIP-TOP DISPENSING CAP
### A II 3/9/2004 SIEGFRIED LTD NICOTINE BITARTRATE DIHYDRATE
### I III 3/10/2004 HENKEL CORP PROXSEAL 8480-107
### A II 3/10/2003 CIPLA LTD VALACYCLOVIR HYDROCHLORIDE DIHYDRATE
USP
### A II 3/5/2004 SIGNA SA DE CV VALPROIC ACID USP
### A II 3/5/2004 SIGNA SA DE CV SODIUM VALPROATE
### A II 3/9/2004 ECKERT AND ZIEGLER RADIOPHARMA YTTRIUM-90 CHLORIDE STERILE SOLUTION
INC
### A II 3/5/2004 BACHEM AMERICAS INC EXENATIDE (BULK)
### I III 3/12/2004 CYTEC SURFACE SPECIALTIES INC PHENODUR(R) PR 612/80B
### I II 3/12/2004 DAIICHI SANKYO CO LTD CS-023 DRUG SUBSTANCE
### I II 3/12/2004 MEDICHEM SA ZALEPLON
### A II 3/12/2004 MEDICHEM SA LAMOTRIGINE
### I III 3/3/2004 CLARIANT AUSTRALIA PTY LTD CUSTOM COLOUR/ADDITIVE CONCENTRATES
FOR USE IN PLASTIC PRODUCTS AND
PACKAGING
### A II 3/12/2004 SIGMA ALDRICH MANUFACTURING LLC POLY-L-LYSINE HYDROCHLORIDE
### A II 3/8/2004 NOF CORP PURIFIED EGG YOLK SPHINGOMYELIN
(PURIFIED EY-SPM)
### A II 2/16/2004 OLON SPA BETAXOLOL HYDROCHLORIDE
Page 552
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 3/9/2004 ZEON CORP CYCLO OLEFIN POLYMER 2
### A III 2/6/2004 NIPRO PHARMAPACKAGING INDIA PVT GLASS CONTAINERS
LTD
### A II 3/16/2004 ANONIMA MATERIE SINTETICHE AND MELOXICAM
AFFINI (AMSA) SPA
### I IV 3/18/2004 COLORCON CHR. HANSEN(TM) CAL-CARB
### A II 3/18/2004 SUN PHARMACEUTICAL INDUSTRIES GABAPENTIN USP
LTD
### I V 3/12/2004 NATIONAL INSTITUTES HEALTH PRECLINICAL STUDIES ON IBOGAINE
NATIONAL INSTITUTE DRUG ABUSE
### A IV 3/5/2004 CAPSUGEL INC POLYSACCHARIDE EMPTY HARD CAPSULES
### A II 3/19/2004 ASPEN OSS BV LEUPRORELIN
### I III 3/18/2004 FLEXTRUS AB TRANSOFOIL EL-OPET/PE LAMINATE, MATERIAL
SPECIFICATION: M80109
### A II 3/19/2004 DR REDDYS LABORATORIES LTD REPAGLINIDE
### A III 3/8/2004 COLORTECH INC 11002-19 WHITE POLYETHYLENE CONCENTRATE
### I III 3/17/2004 DYNA TECH ADHESIVES DYNA-TECH ADHESIVES - TECHCRYL 2233
### I III 3/17/2004 DYNA TECH ADHESIVES DYNA-TECH ADHESIVES - TECHCRYL 6136
Page 553
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 3/17/2004 DYNA TECH ADHESIVES DYNA-TECH ADHESIVES - DYTAC 2105
### A II 3/23/2004 ICROM SPA MINOXIDIL
### A IV 3/25/2004 WILD FLAVORS INC NATURAL BANANA FLAVOR WONF #FAFH080
(ALSO REFERRED TO AS #471608)
### A IV 3/25/2004 WILD FLAVORS INC NATURAL GRAPE FLAVOR WONF #FAFH082
(ALSO REFERRED TO AS #471477)
### I IV 3/25/2004 WILD FLAVORS INC NATURAL GRAPE FLAVOR #FAFH083 (ALSO
REFERRED TO AS #800715)
### A IV 3/25/2004 WILD FLAVORS INC NATURAL BANANA FLAVOR WONF #FAFH079
(ALSO REFERRED TO AS #208830)
### A IV 3/25/2004 WILD FLAVORS INC NATURAL BANANA FLAVOR #FAFH078 (ALSO
REFERRED TO AS #203410)
### A IV 4/5/2004 MANE INC MINT FLAVOR E_0325609
### A II 3/24/2004 LUPIN LTD CEPHALEXIN USP
### I II 3/31/2004 DR REDDYS LABORATORIES LTD ESOMEPRAZOLE MAGNESIUM
### A II 3/31/2004 UQUIFA MEXICO SA DE CV CIPROFLOXACIN
### I II 4/2/2004 POLYCARBON INDUSTRIES INC PCI-8001 (1,2-BENZISOXAZOLE-3-
METHANESULFONAMIDE)
### A III 3/29/2004 POLYONE CORP CC10022488WE
### A III 3/29/2004 POLYONE CORP CC00014040WE
### A III 3/29/2004 POLYONE CORP CC00007232WE
### A III 3/29/2004 POLYONE CORP CC00007234WE
### A II 3/25/2004 SPECGX LLC HYDROCODONE POLISTIREX
### I II 4/2/2004 CADILA HEALTHCARE LTD PAROXETINE HYDROCHLORIDE, ANHYDROUS
### I II 4/6/2004 MYLAN LABORATORIES LTD LORATADINE USP (LDP)
### I II 4/6/2004 SUN PHARMACEUTICAL INDUSTRIES GLIMEPIRIDE
LTD
### A II 4/6/2004 SUN PHARMACEUTICAL INDUSTRIES RIVASTIGMINE TARTRATE USP
LTD
### A II 4/2/2004 PIRAMAL ENTERPRISES LTD KETOCONAZOLE
### I II 3/19/2004 RECORDATI ESPANA SL TERBINAFINE HYDROCHLORIDE
### I II 3/16/2004 APOTECNIA SA ITRACONAZOLE
### I II 3/12/2004 RECORDATI ESPANA SL PAROXETINE HYDROCHLORIDE HEMIHYDRATE
### I II 3/15/2004 APOTECNIA SA FLUCONAZOLE
### A III 3/29/2004 POLYONE CORP CC10007232WE
### A III 3/29/2004 POLYONE CORP CC10007234WE
### I III 3/30/2004 AMPACET CORP 16869-A BLUE (ALCAN CODE WF2804)
POLYETHYLENE MASTERBATCH
### A III 3/30/2004 AMPACET CORP 11078-K LAMITE 78
### A III 3/31/2004 PRESSPART MANUFACTURING LTD RESPIMAT® ALUMINUM CYLINDER
### I II 4/3/2004 SHISEIDO CO LTD CAPCELL C18
### I II 4/5/2004 BASIC PHARMA CHEM CHLORHEXIDINE GLUCONATE (BP)
### I II 3/18/2004 SHANDONG XINHUA PHARMACEUTICAL IRISQUINONE
CO LTD
### A II 4/2/2004 DIPHARMA FRANCIS SRL ZONISAMIDE
Page 554
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 4/8/2004 SANOFI CHIMIE HYDROXY ACID
### A II 4/9/2004 MYLAN LABORATORIES LTD CIPROFLOXACIN USP
### A II 4/12/2004 ZHEJIANG HISUN PHARMACEUTICAL CO ADENOSINE USP
LTD
### A II 4/16/2004 BAYER AG NORGESTREL
### I II 4/6/2004 KUNSHAN DOUBLE CRANE OFLOXACIN
PHARMACEUTICAL CO LTD
### I II 4/7/2004 ARCHER DANIELS MIDLAND CO SIO/BXR REFINED SOYBEAN OIL
### A II 3/31/2004 LUPIN LTD LOVASTATIN
17311 A II 4/1/2004 SPECGX LLC CHLORPHENIRAMINE POLISTIREX
### A II 4/20/2004 SCINOPHARM TAIWAN LTD IRINOTECAN HYDROCHLORIDE
### I III 3/15/2004 CONTINENTALAFA DISPENSING CO DISPENSING PUMPS
### I III 4/15/2004 BRASKEM AMERICA INC POLYPROPYLENE PRODUCTS
### I III 4/15/2004 DOW CHEMICAL CO SARAN
### I II 4/12/2004 ZINCOLLIED INDIA PVT LTD ZINC OXIDE
### A II 4/15/2004 CIPLA LTD SERTRALINE HYDROCHLORIDE (FORM II)
### A II 4/9/2004 LEK PHARMACEUTICALS DD TAMSULOSIN HYDROCHLORIDE
### I II 4/13/2004 UNION QUIMICO FARMACEUTICA SA LABETALOL HYDROCHLORIDE
(UQUIFA SA)
### A II 5/7/2004 NOF CORP DOPS-NA (DIOLEOYL PHOSPHATIDYLSERINE,
SODIUM SALT)
### I II 4/16/2004 KV PHARMACEUTICAL CO DESTAB(TM) FERROUS FUMARATE 90 S ULTRA
### I III 3/25/2004 BOEHRINGER INGELHEIM MICROPARTS RESPIMAT(R) INHALER
GMBH
### A V 8/6/2004 BOEHRINGER INGELHEIM FREMONT INC ABGENIX PRODUCTION FACILITIES IN
FREMONT, CA.
### A II 4/19/2004 CSPC ZHONGNUO PHARMACEUTICAL AMOXICILLIN
SHIJIAZHUANG CO LTD
### A II 4/20/2004 MYLAN LABORATORIES LTD SERTRALINE HYDROCHLORIDE USP (FORM II)
### A II 4/19/2004 FORMOSA LABORATORIES INC BALSALAZIDE DISODIUM DIHYDRATE USP
### A II 4/26/2004 ESTEVE QUIMICA SA LEVETIRACETAM
### I II 4/23/2004 HOVIONE FARMACIENCIA SA 17ST75030
### I II 4/27/2004 QUIMICA SINTETICA SA LANZOPRAZOLE
### A II 4/22/2004 CIPLA LTD TERBINAFINE HYDROCHLORIDE USP
### I IV 4/21/2004 TAKASAGO INTERNATIONAL CORP TAK-020184 MICRON(R) ARTIFICIAL MENTHOL
FLAVOR
### A IV 4/21/2004 TAKASAGO INTERNATIONAL CORP TAK-022173 MICRON(R) NATURAL & ARTIFICIAL
MENTHOL FLAVOR
### A II 4/26/2004 SHANGHAI ZIYUAN PHARMACEUTICAL FOSPHENYTOIN SODIUM USP
CO LTD
### I II 4/28/2004 RANBAXY LABORATORIES LTD CITALOPRAM HYDROBROMIDE
### I II 4/15/2004 SAFC BIOSCIENCES INC EX-CELL(TM) 302, CHO, SERUM-FREE MEDIUM
### I II 4/12/2004 TAIHO PHARMACEUTICAL CO LTD IPD-1151T DRUG SUBSTANCE
### I II 4/22/2004 ASTELLAS PHARMA INC FK330 DRUG SUBSTANCE
### I III 4/28/2004 ROHM AND HAAS CO ADHESIVE E-2723LV
Page 555
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 5/3/2004 ROHM AND HAAS CO ROSBOND PS-67LV
### I III 4/28/2004 ROHM AND HAAS CO ADHESIVE E-2723RG
### I III 4/21/2004 CLARIANT CANADA INC WHITE CLARIANT MASTERBATCH 01MPG-090
### I III 4/21/2004 CLARIANT CANADA INC WHITE CLARIANT MASTERBATCH 01VFV-110
### A II 3/6/2004 ANQIU LUAN PHARMACEUTICAL CO LTD ACETAMINOPHEN USP
### I IV 4/23/2004 BIO INGVIGOR CORP BIODEGRADABLE POLYMERS
### I II 4/22/2004 IPCA LABORATORIES LTD PENTOXIFYLLINE
### A II 4/5/2004 INKE SA GRANISETRON HYDROCHLORIDE
### I II 4/29/2004 SYNKEM SAS CICLOPIROX
### I II 5/13/2004 CHEMWERTH INC IRINOTECAN HCL (NON-STERILE BULK DRUG
SUBSTANCE)
### I II 5/3/2004 PROCOS SPA DIVALPROEX SODIUM
### I II 5/6/2004 MYLAN LABORATORIES LTD CLARITHROMYCIN USP(COP)
### I II 4/29/2004 ERREGIERRE SPA GABAPENTIN
### A II 4/29/2004 MOEHS IBERICA SL SUMATRIPTAN SUCCINATE
### A II 4/27/2004 LUPIN LTD LOVASTATIN USP
### A III 4/22/2004 FENOPLAST LTD RIGID PVC FILM, PVC/PVDC COMPOSITE FILM &
RIGID PVC/PE/PVDC COMPOSITE FILM
### A II 4/26/2004 SCI PHARMTECH INC PROBUCOL
### I II 4/29/2004 SIGMA ALDRICH CO STEMLINE(TM) II HEMATOPOIETIC STEM CELL
EXPANSION MEDIUM
### A II 4/22/2004 PIERRE FABRE MEDICAMENT VINFLUNINE DITARTRATE
### A II 5/5/2004 CADILA HEALTHCARE LTD MELOXICAM USP
### A III 5/3/2004 AICELLO CORP CLEAN BAG SERIES
### I II 6/23/2004 MALLINCKRODT INC OPTIMARK(R) (GADOVERSETAMIDE INJECTION)
PARAMETRIC RELEASE
### I IV 5/3/2004 FONA INTERNATIONAL INC 926.029 NOR-VAN POWDER (A NATURAL &
ARTIFICIAL FLAVOR)
### I IV 5/3/2004 FONA INTERNATIONAL INC 863.002 N-C NATURAL LEMON-LIME FLAVOR
(WONF)
### A II 2/20/2004 CHANGZHOU SIYAO CYPROHEPTADINE HYDROCHLORIDE
PHARMACEUTICALS CO LTD
### I II 5/7/2004 ELAN DRUG DELIVERY INC N1486 NANOCRYSTAL(R) TABLET CORES
### I II 5/10/2004 DR REDDYS LABORATORIES LTD MELOXICAM
### A II 5/5/2004 CHEMO IBERICA SA ISRADIPINE
### A IV 4/22/2004 DAH FENG CAPSULE INDUSTRY CO LTD EMPTY GELATIN CAPSULE (HARD SHELL)
### A II 5/6/2004 SANDOZ GMBH VICA, PURE (3-VINYL-ACA)
### I III 5/5/2004 CCC PLASTICS WHITE MB50-926 POLYPROPYLENE COLOUR
CONCENTRATE
### I II 4/16/2004 THERAGENICS CORP GALLIUM CHLORIDE GA-67 (BULK)
RADIOCHEMICAL
### I II 5/12/2004 SA AJINOMOTO OMNICHEM NV CILOSTAZOL
### I II 5/10/2004 ZHEJIANG HISUN PHARMACEUTICAL CO CHLORAMPHENICOL HEMISUCCINATE
LTD
### I II 5/13/2004 EUTICALS SPA FLUDARABINE PHOSPHATE
Page 556
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 5/13/2004 ORCHID PHARMA LTD CEFPROZIL
### I III 5/13/2004 LORMAC INDUSTRIAL DISTRIBUTORS LORMAC 20 POLYETHYLENE BAGS
LTD
### I III 5/11/2004 CLARIANT CANADA INC RED CLARIANT MASTERBATCH 20PP-1396
### I III 5/11/2004 CLARIANT CANADA INC RED CLARIANT MASTERBATCH 02EHD-1870
### A III 5/14/2004 DYNIC USA CORP HL21 INK-THERMAL TRANSFER RIBBON
### I III 5/14/2004 DYNIC USA CORP NK21 INK-THERMAL TRANSFER RIBBON
### I III 5/11/2004 ROLLPRINT PACKAGING PRODUCTS INC RPP# 17-1006
Page 559
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 2/7/2004 DINESH PHARMACEUTICALS PRIVATE ACETAMINOPHEN USP
LTD
### I II 6/22/2004 ARCHER DANIELS MIDLAND CO SIO/BXR REFINED OLIVE OIL
### I III 6/2/2004 STEAG MICROPARTS GMBH ALUMINUM CYLINDER FOR THE USE WITH
RESPIMAT(R) INHALER CARTRIDGE
### I II 6/22/2004 MEIJI SEIKA PHARMA CO LTD CEFDITOREN PIVOXIL DRUG SUBSTANCE
### I II 6/21/2004 GUFIC BIOSCIENCES LTD LIDOCAINE HYDROCHLORIDE
### I II 6/21/2004 RANBAXY LABORATORIES LTD ATORVASTATIN MAGNESIUM
### I III 6/16/2004 AMCOR FLEXIBLES RAACKMANN PETP 12/ALU 7/LLDPE 60
### I II 6/22/2004 TIANJIN ZHONGAN PHARMACEUTICAL CAFFEINE (ANHYDROUS)
CO LTD
### I II 6/24/2004 USV LTD CARVEDILOL PH. EUR.
### I II 6/25/2004 TRIFARMA SPA OXCARBAZEPINE
### A II 6/21/2004 CAMBREX CHARLES CITY INC TORSEMIDE USP
### A III 6/16/2004 BERRY GLOBAL PRODUCT 60110-18
### A III 6/23/2004 ALTIRA INC PLASTIC BOTTLES
### I IV 6/28/2004 AUXILIUM PHARMACEUTICALS LLC OXACYCLOHEXADECAN-2-ONE
### I III 6/14/2004 POLIMERI EUROPA FRANCE SNC ERACLENE ML70
### I III 6/14/2004 POLIMERI EUROPA FRANCE SNC ERACLENE MR80
### I III 6/14/2004 POLIMERI EUROPA FRANCE SNC ERACLENE MQ70
### I III 6/22/2004 FARMASERVICE SRL ROUND HDPE BOTTLE 200 ML
### I III 6/22/2004 FARMASERVICE SRL ROUND HDPE BOTTLE 150 ML
### I II 6/23/2004 CHUNGHWA CHEMICAL SYNTHESIS AND LOVASTATIN
BIOTECH CO LTD
### I III 6/21/2004 POLIMERI EUROPA FRANCE SNC GREENFLEX FF55
### I II 6/25/2004 FARCHEMIA SRL BALSALAZIDE DISODIUM DIHYDRATE
### A II 6/14/2004 CODY LABORATORIES INC HYDROMORPHONE HYDROCHOLORIDE USP
### I II 6/29/2004 CAMBREX CHARLES CITY INC PROPOXYPHENE HYDROCHLORIDE
### I II 6/28/2004 CAMBREX CHARLES CITY INC PROPOXYPHENE NAPSYLATE
### A II 6/26/2004 SYNBIAS PHARMA AG IDARUBICIN HYDROCHLORIDE
### A III 6/30/2004 ACS DOBFAR SPA STERBAG® PACKAGING SYSTEM
### A II 7/2/2004 HETERO LABS LTD IRBESARTAN (FORM A) PROCESS I
### A III 4/23/2004 PLAMI SA DE CV BLISTER FILMS
### A II 7/1/2004 TEVA PHARMACEUTICAL INDUSTRIES CEFADROXIL
LTD
### I II 7/6/2004 DAIICHI SANKYO CO LTD DW-908E DRUG SUBSTANCE
17511 I II 7/1/2004 ESTEVE QUIMICA SA CITALOPRAM HYDROBROMIDE
### I II 7/6/2004 SANDOZ GMBH SULBACTAM SODIUM (STERILE)
### A II 6/18/2004 UCB FARCHIM SA CETIRIZINE HYDROCHLORIDE
### A IV 6/28/2004 ERAWAT PHARMA LTD EMPTY HARD GELATIN CAPSULE SHELLS &
HPMC CAPSULE SHELLS
### I III 6/17/2004 RIBEYRON FRANCE TECHNICAL FILM
### A II 7/14/2004 KURA ONCOLOGY INC TIPIFARNIB (R115777) DRUG SUBSTANCE
### I II 7/12/2004 CHIFENG ARKER PHARMACEUTICAL PSEUDOEPHEDRINE HYDROCHLORIDE
TECHNOLOGY CO LTD
Page 560
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 7/9/2004 ROHM AND HAAS CO ADCOTE 37P295HV
### A II 7/13/2004 MYLAN LABORATORIES LTD RISPERIDONE USP
### A II 7/13/2004 MYLAN LABORATORIES LTD MIRTAZAPINE USP (HEMIHYDRATE)
### I III 7/9/2004 ROHM AND HAAS CO ADCOTE 2730-2B
### I II 7/8/2004 PERRIGO API LTD DONEPEZIL HYDROCHLORIDE (DILUTED) 25%
AMORPHOUS
### A II 7/14/2004 WOCKHARDT BIO AG CLARITHROMYCIN USP
### A II 7/13/2004 MYLAN LABORATORIES LTD VENLAFAXINE HYDROCHLORIDE USP
### I III 7/8/2004 CHROMA CORP PC56252B 33/1 BLUE COLOR CONCENTRATE
### I III 7/9/2004 GLOBAL ADVANTAGE LLC PVC PACKAGING MATERIAL
### A II 7/14/2004 TARO PHARMACEUTICAL INDUSTRIES HALOBETASOL PROPIONATE USP, MICRONIZED
LTD
### I II 7/3/2004 ZHEJIANG YONGNING 3990 ACID, PHARMACEUTICAL INTERMEDIATE
PHARMACEUTICAL FACTORY
### I II 7/15/2004 BAYER SCHERING PHARMA AG ASOPRISNIL
### A II 7/13/2004 MYLAN LABORATORIES LTD LEVOFLOXACIN USP (HEMIHYDRATE)
### A IV 7/9/2004 UNGERER AND CO ARTIFICIAL GRAPE FLAVOR FI-7723
### A II 7/27/2004 MONACHEM GRADE B NOMAC
### A II 7/19/2004 CIPLA LTD LAMIVUDINE USP
### A II 6/30/2004 SCANDINAVIAN FORMULAS INC SPB11(TM) (SODIUM PHENYLBUTYRATE) 1-
GRAM TABLETS
### A III 6/30/2004 SCANDINAVIAN FORMULAS INC PACKAGING MATERIAL FOR SPB11(TM) (SODIUM
PHENYLBUTYRATE) 1-GRAM TABLETS
### A II 7/12/2004 XELLIA PHARMACEUTICALS LTD GRAMICIDIN, USP
### I III 5/24/2004 ROHM AND HAAS CO COREACTANT T-8384
### A III 7/16/2004 CAPRIHANS INDIA LTD COVER PVC AND PVDC-COATED PVC FILM
PRODUCTS PACKAGING MATERIAL
### A II 7/1/2004 ACS DOBFAR SPA CEFTRIAXONE SODIUM NON STERILE USP
### I II 7/13/2004 SMS PHARMACEUTICALS LTD RANITIDINE HYDROCHLORIDE
### A II 7/19/2004 SOLARA A PHARMA SCIENCES LTD GABAPENTIN USP
### I II 7/20/2004 SUN PHARMACEUTICAL INDUSTRIES FLUTICASONE PROPIONATE EP/BP
LTD
### I II 7/19/2004 UNION QUIMICO FARMACEUTICA SA MODAFINIL
(UQUIFA SA)
### I II 7/19/2004 SANDOZ INDUSTRIAL PRODUCTS GMBH STERILE BULK MIXTURE
AMPICILLIN/SULBACTAM FOR INJECTION
### A II 7/19/2004 TIANJIN TIANYAO PHARMACEUTICALS METHYLPREDNISOLONE USP
CO LTD
### A III 6/16/2004 BERRY GLOBAL PRODUCT 41763-43
### I III 7/1/2004 VALOIS SAS METHODS FOR CONTROLLING VALOIS
PACKAGING COMPONENTS
### I III 7/15/2004 PDC PHARMACEUTICAL DEVELOPMENT PACKAGING MATERIALS AND COMPONENTS
CHINA CO LTD FOR LARGE VOLUME PARENTERAL DRUG AND
BIOLOGICAL PRODUCTS
Page 561
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 7/20/2004 TEVA PHARMACEUTICAL INDUSTRIES LANSOPRAZOLE
LTD
### I III 7/22/2004 MS UNIVERSAL MEDICAP LTD BIOCLEAN BUTYL PHARMA RUBBER CLOSURES
(NON-RFS)
### I III 7/22/2004 UNIVERSAL MEDICAP LTD BIOCLEAN BUTYL PHARMA RUBBER CLOSURES
(RFS)
### I III 7/22/2004 UNIVERSAL MEDICAP LTD BIOCLEAN CHLOROBUTYL PHARMA RUBBER
CLOSURES (NON-RFS)
### I III 7/22/2004 UNIVERSAL MEDICAP LTD BIOCLEAN CHLOROBUTYL PHARMA RUBBER
CLOSURES (RFS)
### I III 7/22/2004 UNIVERSAL MEDICAP LTD BIOCLEAN BROMOBUTYL PHARMA RUBBER
CLOSURES (NON-RFS)
### I III 7/22/2004 UNIVERSAL MEDICAP LTD BIOCLEAN BROMOBUTYL PHARMA RUBBER
CLOSURES (RFS)
### I II 4/26/2004 GLIDE CHEM PVT LTD POVIDONE IODINE
### I II 4/26/2004 GLIDE CHEM PVT LTD CHLORHEXIDINE GLUCONATE SOLUTION 20%
### I II 5/26/2004 MUSTAFA NEVZAT ILAC SANAYII AS SULBACTAM SODIUM (NON-STERILE)
### A II 7/23/2004 FARMABIOS SPA TRIAMCINOLONE DIACETATE
### I II 7/5/2004 AUROBINDO PHARMA LTD 7-AMINO DESACETOXY CEPHALOSPORANIC
ACID (7-ADCA)
### I II 7/20/2004 NV ORGANON NALTREXONE
### A III 7/20/2004 COLORTECH INC 11030-13 WHITE POLYETHYLENE CONCENTRATE
### I II 10/22/2004 ELAN DRUG DELIVERY INC N1296 ORAL NANOCRYSTAL(R) COLLOIDAL
DISPERSION
### A II 10/21/2004 TEVA PHARMACEUTICAL INDUSTRIES OCTREOTIDE ACETATE
LTD
### A II 10/25/2004 TEVA PHARMACEUTICAL INDUSTRIES SILDENAFIL CITRATE
LTD
Page 568
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 10/26/2004 DR REDDYS LABORATORIES LTD DONEPEZIL HYDROCHLORIDE MONOHYDRATE
(FORM-1) USP
### I II 10/20/2004 IPCA LABORATORIES LTD BALSALAZIDE DISODIUM DIHYDRATE
### A II 10/28/2004 ATUL LTD DAPSONE USP
### A II 10/26/2004 HETERO LABS LTD NEVIRAPINE
### A II 10/26/2004 CATALENT PHARMA SOLUTIONS LLC TIPRANAVIR CAPSULES 250 MG (IMPRINTED)
### A II 10/8/2004 OLON SPA BUPROPION HYDROCHLORIDE
### A III 10/21/2004 BPREX HEALTHCARE OFFRANVILLE SAS RISPHARM EYE DROPPERS SETS
Page 575
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 1/20/2005 ZAKLADY FARMACEUTYCZNE BACLOFEN
POLPHARMA SA
### I II 1/12/2005 BIOFER SPA IRON SUCROSE INJECTION
### I II 1/19/2005 SUN PHARMACEUTICAL INDUSTRIES SODIUM VALPORATE EP
LTD
### A II 1/17/2005 SAFC BIOSCIENCES INC EX-CELL(TM) 325 PF CHO, SERUM-FREE
MEDIUM, PROTEIN FREE
### A II 1/21/2005 SANOFI INDIA LTD GLYBURIDE USP (GLIBENCLAMIDE), MILLED
### A II 1/18/2005 JOHNSON MATTHEY PHARMA SERVICES EPOPROSTENOL SODIUM
### A III 1/13/2005 RENOLIT NEDERLAND BV RENOLIT SOLMED ALKA FORMULATIONS
### A II 1/26/2005 CIPLA LTD RIZATRIPTAN BENZOATE USP
### A II 1/26/2005 CIPLA LTD ZALEPLON
### A II 3/22/2005 LUPIN LTD RAMIPRIL USP
### A IV 1/27/2005 BASF SE POLOXAMERS
### I III 1/25/2005 BOREALIS AG FG5224
### I III 1/25/2005 BOREALIS AG FG5223
### A III 1/3/2005 HUMPHREY COSBURN PLASTICS 33/400 WHITE ROUND SMOOTH TOP F/RIBBED
PP CAP
### I II 1/24/2005 NINGBO SMART PHARMACEUTICAL CO GUAIFENESIN USP
LTD
### I II 1/24/2005 ZHEJIANG HISUN PHARMACEUTICAL CO TOLTERODINE TARTRATE, NON-STERILE A
LTD PHARMACEUTICAL INGREDIENT
### A II 1/26/2005 TARO PHARMACEUTICAL INDUSTRIES IMIQUIMOD USP
LTD
### I II 1/25/2005 ALKALOIDS CORP COLCHICINE USP
### A IV 1/29/2005 DAIDO CHEMICAL CORP POVACOAT(TM) (POLYVINYLALCOHOL-ACRYLIC
ACID-METHYL METHACRYLATE COPOLYMER)
### A III 1/17/2005 3M DRUG DELIVERY SYSTEMS DIV SCOTCHPAK 1109
### A III 1/17/2005 3M DRUG DELIVERY SYSTEMS SCOTCHPAK (TM) 1006
### A III 1/17/2005 3M DRUG DELIVERY SYSTEMS DIV SCOTCHPAK (TM) 1020
### I III 1/17/2005 3M DRUG DELIVERY SYSTEMS DIV SCOTCHPAK (TM) 1220
### A III 1/17/2005 3M DRUG DELIVERY SYSTEMS SCOTCHPAK™ 1012
### A III 1/17/2005 3M DRUG DELIVERY SYSTEMS SCOTCHPAK™ 1022
### I III 2/1/2005 BOREALIS AG BOREALIS HE9621-PH
### I III 2/1/2005 BOREALIS AG BOREALIS BORMED(TM) HE2581-PH
### I II 1/31/2005 RANBAXY LABORATORIES LTD ZIPRASIDONE HYDROCHLORIDE
### A II 2/1/2005 FARMABIOS SPA CYPROTERONE ACETATE
### A II 2/1/2005 SANDOZ INDUSTRIAL PRODUCTS SA AMOXICILLIN SODIUM (NON-STERILE BULK)
### I II 1/28/2005 SA AJINOMOTO OMNICHEM NV GALANTAMINE HBR
### I III 2/1/2005 AVERY DENNISON ACCU-PLACE-IN-MOLD LABEL (APIML) PRODUCT
### I V 1/18/2005 MONOGRAM BIOSCIENCES A LABCORP PHENOSENSE(TM) HIV ENTRY TROPISM ASSAY
SUB VALIDATION PACKET
### I II 2/3/2005 CADILA HEALTHCARE LTD SERTRALINE HYDROCHLORIDE
### A II 2/3/2005 APOTEX PHARMACHEM INC ZIPRASIDONE HYDROCHLORIDE
Page 576
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 2/2/2005 CHIFENG PHARMACEUTICAL CO LTD GRISEOFULVIN, USP
### A II 2/1/2005 MEDICHEM SA PAROXETINE HYDROCHLORIDE HEMIHYDRATE
### I II 2/2/2005 POLYCARBON INDUSTRIES INC PCI-8024 (NON-STERILE BULK DRUG
SUBSTANCE)
### I II 2/2/2005 SIMS SRL MESALAMINE
### A II 2/4/2005 LUPIN LTD ZIPRASIDONE HYDROCHLORIDE USP
### A II 2/3/2005 ISOCHEM SAS GEIBROZIL
### A II 1/24/2005 CHENG FONG CHEMICAL CO LTD PHENYLEPHRINE HYDROCHLORIDE
### I II 2/1/2005 SUZHOU WANQING PHARMACEUTICALS LORATADINE
CO LTD
### A II 2/7/2005 WOCKHARDT LTD ZONISAMIDE USP
### I II 2/7/2005 WOCKHARDT LTD STERILE SODIUM CARBONATE
### I III 1/26/2005 AMPACET CORP 111680 WHITE POLYPROPYLENE MASTERBATCH
### A IV 2/25/2005 UNGERER AND CO NATURAL & ARTIFICIAL GRAPE FLAVOR FM-4962
### I II 3/2/2005 SHANGHAI SUNVE PHARMACEUTICAL GEIBROZIL
CO LTD
### A II 3/1/2005 SEKISUI MEDICAL CO LTD N-ACETYL-L-TYROSINE
### I III 3/1/2005 MGJ CORELEN/AI/PTFE LINER
### I II 3/3/2005 BOEHRINGER INGELHEIM PHARMA TIOTROPIUM BROMIDE MONOHYDRATE
GMBH AND CO KG
### A III 1/14/2005 SCHOTT KAISHA PVT LTD GLASS CYLINDERS FOR CARTRIDGES
### I II 3/3/2005 CF PHARMA LTD LAMOTRIGINE
### A II 2/24/2005 HANGZHOU ZHONGMEI HUADONG ACARBOSE
PHARMACEUTICAL CO LTD
### I II 3/7/2005 BOEHRINGER INGELHEIM CHEMICALS FENTANYL BASE
INC
### I IV 3/1/2005 CRODA INC SUPER REFINED NOVOL NF (OLEYL ALCOHOL)
### I II 3/3/2005 CF PHARMA LTD BICALUTAMIDE
### I II 3/4/2005 TEVA PHARMACEUTICAL INDUSTRIES HYDROCORTISONE BUTYRATE DRUG
LTD SUBSTANCE
### A IV 3/8/2005 ROQUETTE FRERES MANNITOL USP POWDER PEARLITOL ®
### A III 2/28/2005 SHREE RUBBERPLAST CO PVT LTD DROPPER BOTTLES, NOZZLES AND CAPS
### A II 3/7/2005 TARO PHARMACEUTICAL INDUSTRIES CARVEDILOL
LTD
### I II 3/2/2005 DAINIPPON SUMITOMO PHARMA CO LTD SMP-797 DRUG SUBSTANCE
### A II 3/4/2005 OLON SPA NAFTIFINE HYDROCHLORIDE
### I II 2/21/2005 BIDACHEM SPA KETOPROFEN
### A II 3/8/2005 ORCHID PHARMA LTD CEFOXITIN SODIUM USP (STERILE)
### A II 3/2/2005 WANBURY LTD METFORMIN HYDROCHLORIDE
### I II 2/24/2005 COATING PLACE INC COATED DEXTROMETHORPHAN POLISTIREX
### I II 3/3/2005 SA AJINOMOTO OMNICHEM NV GALANTAMINE HYDROBROMIDE
### A II 3/4/2005 CADILA HEALTHCARE LTD LOSARTAN POTASSIUM USP
### I II 2/28/2005 AUROBINDO PHARMA LTD CEFOTAXIME SODIUM (STERILE)
### A II 3/7/2005 DISHMAN CARBOGEN AMCIS LTD EPROSARTAN MESYLATE
### A III 3/7/2005 APTAR FRANCE SAS APTAR PACKAGING COMPONENTS FOR
TOPICAL OR TRANSDERMAL APPLICATIONS
Page 579
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 3/10/2005 NORTH CHINA PHARMACEUTICAL AMPHOTERICIN B USP NON-STERILE BULK
HUASHENG CO LTD DRUG
### I II 3/11/2005 URQUIMA SA CARVEDILOL, MICRONIZED
### A II 3/8/2005 UQUIFA MEXICO SA DE CV LEVOFLOXACIN HEMIHYDRATE
### I II 3/10/2005 DERMAL RESEARCH LABORATORIES GEN443 (TM) SODIUM HYALURONATE
INC
### A II 3/11/2005 SANDOZ INDUSTRIAL PRODUCTS SA PIPERACILLIN
### I IV 3/11/2005 BORREGAARD INDUSTRIES LTD CELLOBIOSE OCTAACETATE XP
### A II 3/14/2005 GLENMARK PHARMACEUTICALS LTD BUPROPION HYDROCHLORIDE USP
### A II 3/14/2005 GLENMARK PHARMACEUTICALS LTD ZOLPIDEM TARTRATE USP
### A II 3/14/2005 GLENMARK PHARMACEUTICALS LTD TRANDOLAPRIL USP
### I II 3/8/2005 SAFC BIOSCIENCES INC EX-CELL (TM) 293 MEDIUM
### I II 11/19/2004 SANDOZ INDUSTRIAL PRODUCTS GMBH PACA, PURE
### A III 3/16/2005 JAMES ALEXANDER CORP PLASTIC AMPOULE
### I II 3/15/2005 TEVA GROUP LR-103
### I III 3/7/2005 CARCLO TECHNICAL PLASTICS LTD MDI ACTUATOR AND CAP
### A II 3/3/2005 OLON SPA GABAPENTIN
### A II 3/4/2005 SUN PHARMACEUTICAL INDUSTRIES TOPIRAMATE USP
LTD
### I II 3/2/2005 WANBURY LTD PROMETHAZINE HYDROCHLORIDE
### I II 3/2/2005 WANBURY LTD AMITRIPTYLINE
### A II 3/14/2005 GLENMARK PHARMACEUTICALS LTD TERBINAFINE HYDROCHLORIDE, USP
### A II 2/28/2005 AUROBINDO PHARMA LTD FLUCONAZOLE USP
### I II 3/15/2005 WOCKHARDT LTD FLUOXETINE HYDROCHLORIDE USP
### A II 3/14/2005 CEDARBURG PHARMACEUTICALS INC FENTANYL CITRATE
### I II 3/11/2005 CIPLA LTD TAMSULOSIN HYDROCHLORIDE
### A II 2/25/2005 NATCO PHARMA LTD ONDANSETRON HYDROCHLORIDE
### I III 3/7/2005 AMPACET CORP 180660 BEIGE POLYETHYLENE MASTERBATCH
### I III 3/7/2005 AMPACET CORP 19270 BLACK POLYETHYLENE MASTERBATCH
### I III 3/7/2005 AMPACET CORP 18109 BROWN POLYETHYLENE MASTERBATCH
### I III 3/7/2005 AMPACET CORP 12083 SILVER POLYETHYLENE MASTERBATCH
### I III 3/7/2005 AMPACET CORP 13599 YELLOW POLYETHYLENE MASTERBATCH
### I II 3/14/2005 ZENTIVA KS TAMSULOSIN HYDROCHLORIDE
### A II 3/17/2005 CATALENT PHARMA SOLUTIONS LLC PALONOSETRON HYDROCHLORIDE 0.50 MG
SOFTGELS
### I II 3/15/2005 ZHEJIANG RUIBANG LABORATORIES INC LOVASTATIN USP
### A IV 3/14/2005 STANDARD CHEM AND PHARM CO LTD SODIUM STEARYL FUMARATE
### I II 3/9/2005 PARTICLE DYNAMICS INC DESTAB (TM) MAGNESIUM HYDROXIDE 95%
### A II 3/22/2005 SUN PHARMACEUTICAL INDUSTRIES ZONISAMIDE USP
LTD
### A II 3/11/2005 AUROBINDO PHARMA LTD TERBINAFINE HYDROCHLORIDE USP
### A II 3/22/2005 CYALUME SPECIALTY PRODUCTS INC MEPROBAMATE
### A II 3/23/2005 CEDARBURG PHARMACEUTICALS INC FENTANYL
### I II 3/18/2005 WOCKHARDT LTD DEXTROPROPOXYPHENE NAPSYLATE
(PROPOXYPHENE NAPSYLATE USP)
Page 580
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 3/21/2005 GE HEALTHCARE BIO SCIENCES CORP HOLLOW FIBER TANGENTIAL CARTRIDGE
### I II 3/23/2005 TEVA PHARMACEUTICAL INDUSTRIES ZONISAMIDE
LTD
### I IV 3/22/2005 UNICHEMA CHEMIE BV ARLAMOL (R) E (PPG 15-STEARYL ETHER)
### I II 3/21/2005 GEDEON RICHTER PLC CABERGOLINE
### A II 3/22/2005 ZHEJIANG APELOA JIAYUAN BUPROPION HYDROCHLORIDE USP
PHARMACEUTICAL CO LTD
### I II 3/1/2005 IND SWIFT LABORATORIES LTD VENLAFAXINE HYDROCHLORIDE
### I II 3/28/2005 TEVA PHARMACEUTICAL INDUSTRIES CLOBETASOL PROPIONATE
LTD
### I II 3/24/2005 APOTEX PHARMACHEM INC ZONISAMIDE
### A III 3/21/2005 DYNIC USA CORP HT 8 PLUS WHITE-INK-THERMAL TRANSFER
RIBBON
### I II 3/22/2005 ITF CHEMICAL LTDA LANSOPRAZOLE
### I IV 12/28/2004 FLAVORS NORTH AMERICA INC 825.0033U CHERRY FLAVOR, ARTIFICIAL
### A II 3/25/2005 CADILA HEALTHCARE LTD ZONISAMIDE
### A III 3/21/2005 BERRY GLOBAL (BPREX PHARMA TAMP SAFE (O) PLASTIC CONTAINER CLOSURE
PACKAGING INDIA PRIVATE LTD) SYSTEM
### A III 3/21/2005 BERRY GLOBAL (BPREX PHARMA TAMP SAFE (I) PLASTIC CONTAINER CLOSURE
PACKAGING INDIA PRIVATE LTD) SYSTEM
### A III 3/21/2005 BERRY GLOBAL (BPREX PHARMA TAMP SAFE (R) PLASTIC CONTAINER CLOSURE
PACKAGING INDIA PRIVATE LTD) SYSTEM
18211 A II 3/28/2005 CADILA HEALTHCARE LTD VENLAFAXINE HYDROCHLORIDE USP
### A II 3/28/2005 MYLAN LABORATORIES LTD NABUMETONE USP
### A II 3/30/2005 MYLAN LABORATORIES LTD ESCITALOPRAM OXALATE USP
### A II 3/30/2005 MYLAN LABORATORIES LTD ALPRAZOLAM USP
### I II 3/28/2005 ARCH PHARMALABS LTD 3-PHENYL-5-METHYL ISOXAZOLE-4-CARBONYL
CHLORIDE (PMIC CHLORIDE)
### A II 3/30/2005 SANOFI CHIMIE HYDROXOCOBALAMIN
### A III 3/23/2005 AMPACET CORP 11748-K LAMITE 48
### A III 3/18/2005 BPREX HEALTHCARE OFFRANVILLE SAS OCUMETER PLUS ASSEMBLED BOTTLE
### I III 3/29/2005 INEOS ABS USA CORP LUSTRAN ABS M301 FC 000000 AND LUSTRAN
ABS M301 FC 018646
### A II 4/24/2005 DIVIS LABORATORIES LTD BUPROPION HYDROCHLORIDE USP
### A II 4/26/2005 TEVA PHARMACEUTICAL INDUSTRIES EPIRUBICIN HYDROCHLORIDE LYOPHILIZED
LTD
### A III 4/25/2005 BAXTER HEALTHCARE CORP AVIVA CONTAINER CLOSURE SYSTEM
### I II 4/20/2005 ZHEJIANG APELOA PHARMACEUTICAL SIMVASTATIN USP BULK
CO LTD
### I III 4/27/2005 KUNSTSTOFFWERK KREMSMUNSTER PP 28 CAPS T/E CRC
GMBH
18311 A II 4/29/2005 TORRENT PHARMACEUTICALS LTD SERTRALINE HYDROCHLORIDE DRUG
SUBSTANCE
### A II 4/27/2005 SOLARA A PHARMA SCIENCES LTD IBUPROFEN SODIUM DIHYDRATE
### I II 4/26/2005 HUASHU PHARMACEUTICAL CORP DOXYCYCLINE MONOHYDRATE
### I II 4/26/2005 HUASHU PHARMACEUTICAL CORP DOXYCYCLINE HYCLATE
### A III 4/28/2005 NYPRO INC ORLISTAT 60 MG PORTABLE PACKAGE (R)
### A III 4/13/2005 POLYONE CORP CC00039994BG
### A II 4/27/2005 ZAKLADY FARMACEUTYCZNE CYCLOBENZAPRINE HYDROCHLORIDE
POLPHARMA SA
### A II 4/29/2005 SOCIETA ITALIANA MEDICINALI LIDOCAINE BASE
SCANDICCI SIMS SRL
### A II 5/6/2005 SYN-TECH CHEM AND PHARM CO LTD PHENYLEPHRINE HYDROCHLORIDE USP
### I III 4/20/2005 ADVANCED SCIENTIFICS INC INJECTION MOLDED AUTOCLAVABLE WINGED
SPIKE PORT
### A II 5/26/2005 IPCA LABORATORIES LTD METFORMIN HYDROCHLORIDE USP
### A III 4/28/2005 RELIANCE INDUSTRIES LTD POLYETHYLENE (PE) RELENE B56003 RAW
MATERIAL
### I II 4/15/2005 XIAN LIBANG PHARMACEUTICAL CO LTD DIATRIZOIC ACID BULK
### I III 3/7/2005 PLASPAK QP PTY LTD PLASTIC TABLET BOTTLES
### A II 5/3/2005 TEVA PHARMACEUTICAL INDUSTRIES ALENDRONATE MONOSODIUM TRIHYDRATE
LTD
Page 584
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A V 1/31/2005 PATHEON BIOLOGICS BV MAMMALIAN MANUFACTURING AREAS IN AP
GRONINGEN, THE NETHERLANDS.
### A II 5/9/2005 USV PRIVATE LTD REPAGLINIDE USP
### I II 5/5/2005 SMRUTHI ORGANICS LTD METFORMIN HYDROCHLORIDE USP
### A II 4/30/2005 AUROBINDO PHARMA LTD CEFADROXIL USP
### A III 4/29/2005 BAXTER HEALTHCARE CORP ORAL DISPENSER ACCESSORIES
### I III 4/28/2005 TECH GROUP EUROPE NOVEL DUAL STRIP DPI
### I II 4/27/2005 VENKAT PHARMA LTD OMEPRAZOLE PELLETS 8.5% W/W
### A II 5/6/2005 SCINOPHARM TAIWAN LTD ANASTROZOLE USP
### A II 5/9/2005 ALCAMI WISCONSIN CORP DEXRAZOXANE
### A III 4/15/2005 HUMPHREY COSBURN PLASTICS 250ML WHITE LDPE FLAT OVAL BOTTLE 24/410
### A II 5/9/2004 HETERO LABS LTD RAMIPRIL
### A III 5/10/2005 GRAHAM PACKAGING CO LP PLASTIC CONTAINERS
### A II 5/9/2005 SANOFI AVENTIS DEUTSCHLAND GMBH CLOBAZAM
### A II 5/9/2005 TEVA PHARMACEUTICAL INDUSTRIES QUETIAPINE FUMARATE DRUG SUBSTANCE
LTD
### I II 5/9/2005 DR REDDYS LABORATORIES LTD ESCITALOPRAM OXALATE
### A II 5/24/2005 CHIROGATE INTERNATIONAL INC LATANOPROST
### A IV 5/5/2005 RANQ REMEDIES PVT LTD MICROCRYSTALLINE CELLULOSE USP
### A II 2/11/2005 OLON SPA PENTAZOCINE HYDROCHLORIDE
### A II 5/12/2005 HETERO DRUGS LTD TOPIRAMATE
### A II 5/11/2005 DR REDDYS LABORATORIES LTD VENLAFAXINE HYDROCHLORIDE USP
### A II 5/13/2005 DR REDDYS LABORATORIES LTD METOPROLOL SUCCINATE USP
### A III 5/12/2005 DYNIC USA CORP HL35 INK-THERMAL TRANSFER RIBBON
### A III 5/12/2005 EXXONMOBIL CHEMICAL CO CHLORINATED ISOBUTYLENE-ISOPRENE
RUBBER
### I III 5/13/2005 BOREALIS AG BORMED HE7541-PH
### A II 5/13/2005 FARMABIOS SPA HALCINONIDE
### I II 5/17/2005 GEDEON RICHTER LTD LAMOTRIGINE
### A II 4/28/2005 YANTAI DONGCHENG BIOCHEMICALS HEPARIN SODIUM, INJECTABLE GRADE NON-
CO LTD STERILE BULK DRUG
### I II 5/18/2005 SUN PHARMACEUTICAL INDUSTRIES LAMOTRIGINE USP
LTD
### A IV 5/16/2005 NATURAL CAPSULES LTD EMPTY HARD CELLULOSE CAPSULES (VEGE
CAPSULES)
### A IV 5/16/2005 NATURAL CAPSULES LTD EMPTY HARD GELATIN CAPSULES
### A IV 5/16/2005 NATURAL CAPSULES LTD EMPTY HARD GELATIN CAPSULES
### A II 6/26/2007 HETERO LABS LTD TORSEMIDE
### I II 5/20/2005 UNIMARK REMEDIES LTD CEPHALEXIN USP
### A II 4/14/2005 CKD BIO CORP CLAVULANATE POTASSIUM WITH SILICON
DIOXIDE IN THE RATIO 1:1, NON-STERILE BULK
DRUG SUBSTANCE
### A II 4/14/2005 CKD BIO CORP CLAVULANATE POTASSIUM WITH
MICROCRYSTALLINE CELLULOSE IN THE RATIO
1:1
Page 585
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 5/16/2005 ION EXCHANGE INDIA LTD SODIUM POLYSTYRENE SULFONATE USP
(INDION 254)
### A IV 5/16/2005 ION EXCHANGE INDIA LTD INDION 204
### A IV 5/16/2005 ION EXCHANGE INDIA LTD INDION 234
### A IV 5/19/2005 WILD FLAVORS INC NATURAL BANANA FLAVOR WONF #FAFH079
### A II 5/18/2005 NUVIEW LIFE SCIENCES INC SODIUM IODIDE (I-123) RADIOCHEMICAL
### I V 4/4/2005 A BIO PHARMA PTE LTD CGMP MANUFACTURING FACILITY FOR
PRODUCTION OF BIOLOGICS FOR CLINICAL
TRIALS IN SINGAPORE.
### A V 5/11/2005 WEST PHARMACEUTICAL SERVICES INC WESTAR RS PROCESS IN ESCHWEILER
### A III 11/16/2004 UNITED CLOSURES AND PLASTICS LTD PP28 MEDI-LOC CLOSURES
### I III 5/25/2005 MEYERS COLOUR COMPOUNDS LTD MEYERS COLOUR COMPOUNDS WHITE
MMB9524
### I II 5/24/2005 CATALENT PHARMA SOLUTIONS LLC NIMODIPINE 30MG SOFTGELS
### A II 5/26/2005 USV PRIVATE LTD BICALUTAMIDE
### A II 5/26/2005 PRIME EUROPEAN THERAPEUTICALS EBAB
SPA (EUTICALS SPA)
### I III 5/21/2005 COPE ALLMAN JAYCARE LTD 250ML PET ROUND PACKER
### I III 5/21/2005 COPE ALLMAN JAYCARE LTD 500ML PET ROUND PACKER
### A II 5/26/2005 CIPLA LTD SALMETEROL XINAFOATE
### A II 5/21/2005 IND SWIFT LABORATORIES LTD PIOGLITAZONE HYDROCHLORIDE USP
### I II 5/25/2005 ZHEJIANG XIANJU PHARMACEUTICAL DELTA CORTISONE ACETATE
CO LTD
### I II 5/27/2005 DR REDDYS LABORATORIES LTD OXCARBAZEPINE
### A II 5/27/2005 BASF CORP POLOXALENE USP
### I II 6/1/2005 ERREDUE SPA INNOVATIVE CHEMICAL OXCARBAZEPINE
AND LIFE
### I II 5/27/2005 SYNTHON BV SIMVASTATIN
### A II 5/31/2005 CRYSTAL PHARMA SAU DORZOLAMIDE HYDROCHLORIDE
### I II 5/21/2005 AUROBINDO PHARMA LTD CEFAZOLIN SODIUM USP
### I II 5/27/2005 DR REDDYS LABORATORIES LTD MESALAMINE
### A II 6/3/2005 NATCO PHARMA LTD LETROZOLE
### I II 6/1/2005 DANIPHARM AS LACTULOSE PURUM LIQUIDUM
### A II 5/31/2005 CHONGQING PHARMACEUTICAL IRON SUCROSE (NON-STERILE BULK DRUG
RESEARCH INSTITUTE CO LTD SUBSTANCE)
### A II 5/31/2005 JOHNSON MATTHEY PHARMA SERVICES TALAPORFIN SODIUM
### I II 6/3/2005 NATCO PHARMA LTD TAMSULOSIN HYDROCHLORIDE
### I II 5/11/2005 CHIFENG ARKER PHARMACEUTICAL DIRITHROMYCIN USP, NON-STERILE DRUG
TECHNOLOGY CO LTD SUBSTANCE
### A II 6/3/2005 NATCO PHARMA LTD SALMETEROL XINAFOATE
### A II 5/27/2005 DR REDDYS LABORATORIES LTD CETIRIZINE DIHYDROCHLORIDE
### I II 6/3/2005 URQUIMA SA GLIMEPIRIDE, MICRONISED
### A II 5/23/2005 POLYMED THERAPEUTICS INC PACLITAXEL DRUG SUBSTANCE
### A II 6/1/2005 DAITO PHARMACEUTICALS CO LTD AZELASTINE HYDROCHLORIDE USP
Page 586
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 6/1/2005 ADVANEX EUROPE LTD GSK TORSION HUB SPRINGS
### I II 6/10/2005 CML EUROPE BV PHENELZINE SULFATE
### A II 5/22/2005 AUROBINDO PHARMA LTD NEVIRAPINE HEMIHYDRATE USP
### I II 6/6/2005 MOREPEN LABORATORIES LTD ATORVASTATIN CALCIUM AMORPHOUS, BULK
SUBSTANCE
### I II 6/2/2005 BAYER PHARMA AG LEVONORGESTREL (DCM)
### I II 6/7/2005 SANDOZ GMBH MYCOPHENOLIC ACID PURE
### I II 6/2/2005 CIPLA LTD SERTRALINE HYDROCHLORIDE (FORM-I)
### A IV 3/23/2005 MANE INC BANANA FLAVOR E_0501695
### A IV 3/15/2005 MANE INC ARANCIA FLAVOR E_9940619/01
### I II 6/7/2005 DR REDDYS LABORATORIES LTD DUTASTERIDE (Process-I)
### A II 6/8/2005 SANOFI CHIMIE DRONEDARONE HYDROCHLORIDE
### A III 6/3/2005 3M DRUG DELIVERY SYSTEMS 3M COTRAN™ 9773 POLYOLEFIN FOAM TAPE
18411 I II 6/9/2005 SUN PHARMACEUTICAL INDUSTRIES MODAFINIL
LTD
### A II 6/9/2005 DR REDDYS LABORATORIES LTD ROPINIROLE HYDROCHLORIDE
### A II 6/9/2005 ZIBO XINHUA PERRIGO IBUPROFEN USP DRUG SUBSTANCE
PHARMACEUTICAL CO LTD
### A III 6/10/2005 SHRIJI POLYMERS INDIA LTD HIGH DENSITY POLYETHYLENE BOTTLES
### A III 5/24/2005 BERRY GLOBAL PRODUCT 41809-26
### A III 5/26/2005 SCHOTT SCHWEIZ AG TOPPAC™ SYRINGE
### A II 6/9/2005 H LUNDBECK AS GABOXADOL MONOHYDRATE
### A III 6/10/2005 PLASTIAPE SPA DRY POWDER INHALER MODEL 8
### A II 6/7/2005 WACKER CHEMIE AG ELASTOSIL(R) LR 3003/20 A/B - RAL 6010
### A II 6/9/2005 JOHNSON MATTHEY PHARMACEUTICAL SUFENTANIL BASE
MATERIALS
### A II 6/9/2005 CIPLA LTD LAMOTRIGINE USP
### A II 6/9/2005 CIPLA LTD DONEPEZIL HYDROCHLORIDE FORM-I
### A III 6/6/2005 HUMPHREY COSBURN PLASTICS 20MM GREEN M14102 PP OVERCAP
### I II 5/19/2005 WELDING GMBH AND CO KG CRUDE HEPARIN SODIUM
### I III 1/14/2005 KLOCKE VERPACKUNGS SERVICE NOA44X NOVEL PACKAGING SYSTEM
GMBH
### I II 6/15/2005 SUN PHARMACEUTICAL INDUSTRIES GRANISETRON HYDROCHLORIDE
LTD
### A III 5/24/2005 SONOLITE PLASTICS CORP ENEMA APPLICATOR ASSEMBLY
### A II 6/8/2005 INDUSTRIALE CHIMICA SRL IDEBENONE
### A II 6/13/2005 WACKER CHEMIE AG ELASTOSIL(R) LR 3003/30 A/B - RAL 6010
### A II 6/10/2005 LUPIN LTD ZOLPIDEM TARTRATE USP
### A II 6/15/2005 WACKER CHEMIE AG ELASTOSIL(R) LR 3003/70 A/B - RAL 6010
### I III 6/6/2005 MAC CLOSURES INC FLIP TOP CHILD RESISTANT CONTAINER
### A II 6/16/2005 TEVA PHARMACEUTICAL INDUSTRIES LEVALBUTEROL HYDROCHLORIDE
LTD
### I II 6/16/2005 HETERO DRUGS LTD CEFPROZIL MONOHYDRATE
### A II 6/17/2005 JOHNSON MATTHEY PHARMA SERVICES CANGRELOR
Page 587
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 6/17/2005 UNION QUIMICO FARMACEUTICA SA MEMANTINE HYDROCHLORIDE
(UQUIFA SA)
### A II 6/17/2005 SAFC BIOSCIENCES INC EX-CELL™ 302 CHO, SERUM-FREE MEDIUM, W/O
L-GLUTAMINE, W/O PHENOL RED, W/O NAHC03
### I V 4/15/2005 DAIDS NIAID NIH CURRICULA VITAE (CV) FOR ACUTE INFECTION
AND EARLY DISEASE RESEARCH PROGRAM
(AIEDRP) INVESTIGATORS.
### A II 6/27/2005 SANDOZ GMBH CEFDINIR
### I II 6/24/2005 MEDAREX INC MDX-1303 VALORTIM (TM), ANTI-BACILLUS
ANTHRACIS PROTECTIVE ANTIGEN HUMAN
MONOCLONAL ANTIBODY
### A II 6/27/2005 EXCELLA GMBH AND CO KG DEFEROXAMINE MESYLATE
### A II 6/30/2005 DAIICHI SANKYO CO LTD SUN11031 (HUMAN GHRELIN) DRUG
SUBSTANCE
### I II 6/29/2005 CHEMWERTH INC DOXORUBICIN HYDROCHLORIDE USP (NON-
STERILE, BULK DRUG SUBSTANCE)
### I IV 6/4/2005 DOW CHEMICAL CO WALOCEL(R) HM HYPROMELLOSE USP
### I II 6/29/2005 SYMED LABS LTD GEIBROZIL
### A II 6/24/2005 NEULAND LABORATORIES LTD CIPROFLOXACIN USP
Page 588
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 6/29/2005 APOTEX PHARMACHEM INDIA PVT LTD TORSEMIDE USP
### I II 6/29/2005 DR REDDYS LABORATORIES LTD TRANDOLAPRIL
### A II 6/29/2005 DR REDDYS LABORATORIES LTD ATORVASTATIN CALCIUM (AMORPHOUS)
### A II 6/28/2005 AUROBINDO PHARMA LTD CEFPROZIL USP
### A II 6/30/2005 APOTEX PHARMACHEM INC MIDODRINE HYDROCHLORIDE USP
### I II 6/30/2005 DR REDDYS LABORATORIES LTD ARIPIPRAZOLE
### A II 6/30/2005 JOHNSON MATTHEY PHARMACEUTICAL OXYCODONE HYDROCHLORIDE
MATERIALS
### A III 6/25/2005 POLYONE CORP CC00015929WE/DR
### A III 7/1/2005 MGJ CORELEN/TRESYLENE LINERS
### I III 6/28/2005 POLIMERI EUROPA FRANCE RIBLENE MP31
### I III 6/28/2005 POLIMERI EUROPA FRANCE FLEXIRENE MS26
### A II 6/28/2005 NANTONG JINGHUA PHARMACEUTICAL FLUOROURACIL USP
CO LTD
### I II 6/28/2005 SAFC BIOSCIENCES INC EX-CELL(TM) 325 PF CHO, SERUM-FREE
MEDIUM, PROTEIN-FREE (MODIFIED), W/O L-
GLUTAMINE, W/O PHENOL RED, W/O NAHC03
### A II 7/6/2005 UQUIFA MEXICO SA DE CV PANTOPRAZOLE SODIUM
### A II 7/5/2005 DIVIS LABORATORIES LTD NIACIN USP
### A II 7/6/2005 BIOCON LTD REPAGLINIDE
### A II 7/6/2005 STERLING SPA FINASTERIDE
### A III 7/5/2005 INDIAN SCIENTIFIC GLASS INDUSTRIES NEUTRAL GLASS AMPOULES
### A III 7/5/2005 KHEMKA GLASS PRODUCTS PVT LTD GLASS CYLINDERS, DENTAL LOCAL
ANESTHETICS CARTRIDGES AND PEN
INJECTOR CARTRIDGES
### A IV 6/22/2005 TAKASAGO INTERNATIONAL CORP TAK-051367 INTENSATES(R) NATURAL &
ARTIFICIAL PEPPERMINT MASK (859)
### A III 7/5/2005 KHEMKA GLASS PRODUCTS PVT LTD NEUTRAL GLASS VIALS
### A II 7/7/2005 HETERO LABS LTD ZONISAMIDE
### I II 7/8/2005 SANDOZ INDUSTRIAL PRODUCTS SA GABAPENTIN (NON-STERILE BULK)
### A III 7/7/2005 PACIFIC VIAL MANUFACTURING INC GLASS VIALS
### I III 7/5/2005 RICON COLORS INC WHITE, CPP-W1528-1
### A III 7/8/2005 INEOS STYROLUTION AMERICA LLC GENERAL PURPOSE POLYSTYRENE (GPPS) AND
HIGH IMPACT POLYSTYRENE (HIPS)
### A II 7/7/2005 BIOCON LTD FLUVASTATIN SODIUM AMORPHOUS
### A II 7/11/2005 CHUNGHWA CHEMICAL SYNTHESIS AND MYCOPHENOLATE MOFETIL USP
BIOTECH CO LTD
### I II 7/12/2005 MYLAN LABORATORIES LTD INDINAVIR SULFATE USP
### A II 7/7/2005 HETERO LABS LTD BICALUTAMIDE (FORM-H1)
### I II 7/5/2005 ZHEJIANG HISUN PHARMACEUTICAL CO VANCOMYCIN HYDROCHLORIDE USP (NON-
LTD STERILE, A PHARMACEUTICAL INGREDIENT)
### I II 7/6/2005 ZHEJIANG HISUN PHARMACEUTICAL CO EPIRUBICIN HYDROCHLORIDE (LYOPHILIZED)
LTD NON-STERILE A PHARMACEUTICAL INGREDIENT
### A II 7/12/2005 MYLAN LABORATORIES LTD CARVEDILOL USP
### I II 7/12/2005 MYLAN LABORATORIES LTD NELFINAVIR MESYLATE
Page 589
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 7/11/2005 CADILA HEALTHCARE LTD OMEPRAZOLE
### A II 7/1/2005 MERCK KGAA CALCIUM CHLORIDE DIHYDRATE
### I II 7/12/2005 MYLAN LABORATORIES LTD AMLODIPINE BESILATE USP (AYP)
### A II 7/12/2005 SUN PHARMACEUTICAL INDUSTRIES OXCARBAZEPINE USP
LTD
### A II 7/11/2005 ORCHID PHARMA LTD CEFPODOXIME PROXETIL USP (NON-STERILE
BULK)
### A II 7/11/2005 PFIZER HEALTHCARE INDIA PVT LTD TAZOBACTAM ACID USP
### A III 7/11/2005 NEMERA SERVICES METERED DOSE INHALER ACTUATORS
### A II 7/6/2005 SPECGX LLC COMPAP™ COURSE L
### A II 7/12/2005 SCINOPHARM TAIWAN LTD EFLORNITHINE HYDROCHLORIDE
### I II 7/5/2005 PCAS FELODIPINE
18511 A III 7/14/2005 FARMACAP INDUSTRIA E COMERCIO RUBBER STOPPERS
LTDA
### I III 7/14/2005 COMPANHIA INDUSTRIAL DE VIDROS CIV GLASS VIALS
### A III 8/1/2005 ANADOLU CAM SANAYII AS ESKISEHIR PHARMACEUTICAL GLASS CONTAINERS
FABRIKASI
### A II 7/29/2005 HELSINN ADVANCED SYNTHESIS SA TROSPIUM CHLORIDE
### I II 7/20/2005 OLON SPA NIZATIDINE
### I II 7/20/2005 OLON SPA SPIRONOLACTONE
### A III 7/26/2005 BERRY GLOBAL (BPREX PHARMA TAMP LOCK / DOUBLE SAFE (R) PLASTIC
PACKAGING INDIA PRIVATE LTD) CONTAINER CLOSURE SYSTEM
### I III 7/26/2005 REXAM PHARMA PACKAGING INDIA PVT PLASTIC CONTAINER & CLOSURES FOR ORAL
LTD PREPARATION
### A IV 7/25/2005 KERRY CANADA INC GRAPE NAT/ART FLAVOR 707820
### I III 8/1/2005 COLORS FOR PLASTICS INC W07071-XRF
### I II 7/28/2005 CRYSTAL PHARMA SAU FINASTERIDE
### I III 7/26/2005 AMCOR FLEXIBLES BURGDORF GMBH COMPOUND PACKAGING MATERIAL (LAMINATE)
PETP 12/ALU 12/LDPE 40 (SOP 51810)
### A III 7/26/2005 AMCOR FLEXIBLES BURGDORF GMBH COMPOUND PACKAGING MATERIAL (LAMINATE)
PETP 12/ALU 12/LDPE50 (SOP 51811)
### A II 7/25/2005 ZHEJIANG CHARIOTEER NAPROXEN USP (BULK)
PHARMACEUTICAL CO LTD
### I III 7/19/2005 COPE ALLMAN JAYCARE LTD 150ML PET ROUND PACKER
### A II 8/1/2005 ASPEN OSS BV ESTERIFIED ESTROGENS AC
### A II 8/2/2005 SANDOZ GMBH HEPARIN SODIUM
### A II 7/25/2005 AUROBINDO PHARMA LTD CIPROFLOXACIN HYDROCHLORIDE USP
### I II 8/3/2005 SUN PHARMACEUTICAL INDUSTRIES ESOMEPRAZOLE MAGNESIUM (AMORPHOUS,
LTD NON-STERILE BULK DRUG SUBSTANCE)
### A III 8/3/2005 POLYONE CORP CC10042164WE
### A II 8/5/2005 CORDEN PHARMA BRUSSELS SA LARAZOTIDE
### A II 7/29/2005 OLON SPA MEMANTINE HYDROCHLORIDE
### A II 11/11/2005 IPCA LABORATORIES LTD HYDROCHLOROTHIAZIDE USP, PROCESS II
### A II 7/30/2005 IND SWIFT LABORATORIES LTD ROPINIROLE HYDROCHLORIDE USP
### A II 8/1/2005 POLYPEPTIDE SA EPTIFIBATIDE DRUG SUBSTANCE
### A II 8/4/2005 TRIFARMA SPA HALOBETASOL PROPIONATE
### A III 8/3/2005 EMS CHEMIE NORTH AMERICA INC GRILAMID TR 55 NATURAL
### A III 7/27/2005 LONSTROFF AG E5218C GREY
### A III 8/3/2005 PRESSPART GMBH AND CO KG ALUMINUM ALLOY METERED DOSE INHALER
CONTAINERS (ANODIZED AND INTERNALLY
COATED)
Page 591
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 7/29/2005 AMPACET CORP 102286 CLARITY SLIP AB POLYETHYLENE
MASTERBATCH
### I II 8/8/2005 DAINIPPON SUMITOMO PHARMA CO LTD SMP-114
### I II 5/7/2005 CHIFENG ARKER PHARMACEUTICAL PSEUDOEPHEDRINE SULFATE USP
TECHNOLOGY CO LTD
### I II 5/7/2005 CHIFENG ARKER PHARMACEUTICAL BALSALAZIDE DISODIUM DIHYDRATE
TECHNOLOGY CO LTD
### I IV 8/5/2005 AEGIS THERAPEUTICS LLC INTRAVAIL(TM) A-5 (TETRADECYLMALTOSIDE)
### I III 8/10/2005 ARKEMA INC PLEXIGLAS(R) HF110-101, PLEXIGLAS(R)
HF110G-101 AND PLEXIGLAS(R) VS-100
### A II 7/30/2005 AUROBINDO PHARMA LTD NEVIRAPINE ANHYDROUS USP
### I II 6/6/2005 SHIJIAZHUANG PHARMACEUTICAL ALENDRONATE SODIUM USP 28
GROUP HUASHENG PHARMA CO LTD
### I II 4/29/2005 SHIJIAZHUANG PHARMACEUTICAL TRAMADOL HYDROCHLORIDE EP
GROUP HUASHENG PHARMA CO LTD
### I II 8/8/2005 GUANGZHOU HUANYE VINCRISTINE SULFATE USP (NON-STERILE BULK
PHARMACEUTICAL CO LTD DRUG)
### I II 8/11/2005 GUANGDONG NEW NORTH RIVER PRAVASTATIN SODIUM
PHARMACEUTICAL CO LTD
### A II 6/24/2005 SOUTHWEST SYNTHETIC NABUMETONE USP
PHARMACEUTICAL CORP LTD
### I III 8/11/2005 AMERICHEM INC SOLUTOL HS 15 PRE-CLINICAL SAFETY DATA
### A III 8/11/2005 AMERICHEM INC 46603-CD2 RED
### I II 8/15/2005 INCELL CORP LLC ACE(TM) CELL CULTURE MEDIUM
### A II 8/15/2005 INCELL CORP LLC EZ-CPZ(TM) AND EZ-CPZ-H(TM) CELL
CRYOPRESERVATION MEDIA
### I II 5/24/1991 CENTOCOR INC HUMAN-MURINE CHIMERIC MONOCLONAL
ANTIBODY TO TUMOR NECROSIS FACTOR FOR
SEPSIS (CENTOCOR)
### I II 5/28/1991 BERKLEY ANTIBODY CO MURINE MONOCLONAL ANTIBODY PRODUCTION
(ASCITES)
### I II 9/14/1990 IMMUNOMEDICS INC MURINE MONOCLONAL ANTIBODY AND F(AB)2
FRAGMENT (IMMU-14) TO CARCINOEMBRYONIC
ANTIGEN (CEA)
### I II 5/8/1987 NEORX CORP 99M TC MURINE MONOCLONAL ANTIBODIES TO
HUMAN CARCINOMA SURFACE ANTIGEN (P39)
### I II 3/16/1989 YU ALICE L MD PHD CHIMERIC (HUMAN/MURINE) MONOCLONAL
ANTIBODY (14.18) TO GD2 ANTIGEN
(NEUROBLASTOMA)
### I II 4/15/1988 YU ALICE L MD PHD MURINE MONOCLONAL ANTIBODY (14G2A) TO
GD2
### I II 9/22/1987 CENTOCOR INC 99M-TC-MURINE MONOCLONAL ANTIBODY (FAB')
(T2G1S) TO HUMAN FIBRIN II (B-CHAIN)
Page 592
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 3/19/1985 CENTOCOR INC EDRECOLOMAB [MURINE MONOCLONAL
ANTIBODY (17-1A) TO COLORECTAL
CARCINOMA]
### I II 8/22/1988 PROGEN INDUSTRIES PTY LTD MONOCLONAL ANTIBODIES
### A II 2/13/1985 LONZA BIOLOGICS PLC IMMOBILIZED MONOCLONAL ANTIBODY (NK2) TO
INTERFERON
### I V 4/25/1986 SANOFI WINTHROP INC MANUFACTURING FACILITY - INTERFERON
### I II 3/21/1988 BIOLOGICAL THERAPY INSTITUTE MURINE MONOCLONAL ANTIBODIES
### I II 7/14/1988 BIOLOGICAL THERAPY INSTITUTE MITOMYCIN-C CONJUGATED MURINE
MONOCLONAL ANTIBODIES
### I II 4/28/1989 IMMUNOMEDICS INC MURINE MONOCLONAL ANTIBODY (IMMU-31) TO
ALPHA-FETOPROTEIN
### I II 5/5/1989 NEORX CORP RHENIUM RE 186 CONJUGATED (MAGG) MURINE
MONOCLONAL ANTIBODY (NR-LU-10) TO HUMAN
CARCINOMA SURFACE ANTIGEN (P39)
### I II 9/28/1989 BIOINVENT PRODUCTION AB MONOCLONAL ANTIBODY PRODUCTION
### I II 11/2/1989 IMMUNOMEDICS INC MURINE MONOCLONAL ANTIBODY (IMM-LL-2) TO
B-CELL LYMPHOMA AND LEUKEMIA CELLS
### I II 12/12/1989 BEN VENUE LABORATORIES INC PEG-L-ASPARAGINASE
### I II 7/3/1991 MILLIPORE CORP DURAPORE FILTER MEMBRANE
### I II 8/1/1991 MEDAREX INC MURINE MONOCLONAL ANTIBODY (PM-81) TO
HUMAN MYELOID DIFFERENTIATION ANTIGEN
### I II 12/13/1991 GOODWIN BIOTECHNOLOGY INC PRODUCTION OF MONOCLONAL ANTIBODIES
### I II 6/30/1992 INSTITUTE MOLECULAR BIOLOGY INC INSULIN-LIKE GROWTH FACTOR-I (HUMAN,
RECOMBINANT, YEAST, INSTITUTE OF
MOLECULAR BIOLOGY)
### I II 6/30/1992 INSTITUTE MOLECULAR BIOLOGY INC PLATELET DERIVED GROWTH FACTOR-BB
(HUMAN, RECOMBINANT, C-127 MOUSE
MAMMARY CELLS, INSTITUTE OF MOLECULAR
BIOLOGY)
### I II 8/14/1992 EISAI INC INTERLEUKIN-2 DIPHTHERIA TOXIN FUSION
PROTEIN (DAB 389 IL-2)
18611 I II 8/13/1992 MILLIPORE CORP VIRAL FILTER MEMBRANES (MILLIPORE)
### I II 6/25/1990 DOW CHEMICAL CO MURINE MONOCLONAL ANTIBODY (COL-1) TO
CEA
### I II 7/13/1990 GENETICS INSTITUTE INC -MODIFIED TISSUE PLASMINOGEN ACTIVATOR,
FEIX, (DEL 6-86, ASP-GLU117) (RECOMBINANT,
HUMAN, CHO CELLS)
### A II 10/22/1992 HEMISPHERX BIOPHARMA INC INTERFERON ALFA-N3 GEL (HUMAN
LEUKOCYTE, INTERFERON SCIENCES)
### I II 3/22/1993 NATIONAL INSTITUTES HEALTH PSEUDOMONAS EXOTOXIN (RECOMBINANT,
NATIONAL CANCER INSTITUTE NLYSPE38) CONJUGATED MURINE MAB (B3) TO
B3 ANTIGEN AND RITUXIMAB [CHIMERIC MOAB
(C2B8) (IDEC) TO CD20]
Page 593
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 1/17/1989 HOECHST MARION ROUSSEL MURINE MONOCLONAL ANTIBODY BMA-031 TO T
DEUTSCHLAND GMBH CELL RECEPTOR
### A II 4/1/1993 BOEHRINGER INGELHEIM PHARMA NR-LU-10 MURINE MONOCLONAL ANTIBODY FAB
GMBH AND CO KG FRAGMENT (NOFETUMOMAB) AND
PHENTHIOATE LIGAND BULK MATERIAL FOR
ONCOTRAC KIT (NEORX)
### I II 6/29/1993 PIERCE CHEMICAL CO HYDRATED AZLACTONE FUNCTIONAL BEADS AS
BIOSUPPORT MEDIUM
### I II 10/8/1993 SERAGEN INC SUB LIGAND EPIDERMAL GROWTH FACTOR DIPHTHERIA
PHARMACEUTICALS INC TOXIN FUSION PROTEIN (DAB389EGF)
### I II 5/23/1988 SYNTEX USA INC INTERLEUKIN-1 BETA (RECOMBINANT, E. COLI)
(IMMUNEX)
### I II 11/12/1993 ENZON INC BULK SINGLE CHAIN FV MONOCLONAL
ANTIBODY (CC49) (MURINE, RECOMBINANT,
E.COLI) TO TAG-72
### I II 11/11/1993 GENENTECH INC TUMOR NECROSIS FACTOR RECEPTOR
IMMUNOGLOBULIN G
### I II 12/14/1993 NEORX CORP MURINE MONOCLONAL ANTIBODY (NR-LU-10)
FAB FRAGMENT AND PHENTHIOATE LIGAND
BULK MATERIAL FOR ONCOTRAC KIT
(MANUFACTURING HISTORY)
### I II 12/31/1991 SEPRACOR INC MEMBRANE AFFINITY PURIFIER FOR
ANTIBODIES AND OTHER BIOLOGICALS
### I II 9/3/1993 NEORX CORP MURINE MONOCLONAL ANTIBODY (NR-LU-
10)/STREPTAVADIN CONJUGATE LABELED
W/RHENIUM-186 CONJUGATE (MAG2GABA),
BIOTIN-GALACTOSE-HSA, INDIUM-111/YTTRIUM-
90-DOTA-BIOTIN
### A II 2/1/1994 HYCLONE LABS INC HYCLONE CCM MEDIA PRODUCTS
### I II 3/16/1994 DOW CHEMICAL CO CHIMERIC (MURINE VARIABLE, HUMAN
CONSTANT) MONOCLONAL ANTIBODY (CC49) TO
TUMOR ASSOCIATED GLYCOPROTEIN (TAG)-72
Page 594
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 9/16/1994 GLAXOSMITHKLINE CHIMERIC (MACAQUE VARIABLE/HUMAN
CONSTANT) (RECOMBINANT, CHO CELLS)
MONOCLONAL ANTIBODY (SB 210396; CE9.1) TO
HUMAN CD4 ANTIGEN
### I II 11/4/1994 NEORX CORP TECHNETIUM-TC-99M LABELED R-ANNEXIN V
(NEORX)
### I II 2/21/1995 CEL SCI CORP LEUKOCYTE INTERLEUKIN, INJECTION
### I V 2/24/1995 CHIRON BETA CORP CHIRON BETA CORPORATION, CANOVANAS
PUERTO RICO
### I II 2/23/1995 BOEHRINGER INGELHEIM PHARMA INTERLEUKIN-12 BULK SUBSTANCE
GMBH AND CO KG
### I II 4/4/1995 BIOTRANSPLANT INC RAT MONOCLONAL ANTIBODY (BTI-322) TO CD2+
T CELLS AND NK CELLS (BIOTRANSPLANT) OR
MUROMONAB-CD3 (OKT3, ORTHO) EACH WITH
IMMUNOSUPPRESSIVE AGENTS
Page 595
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 1/12/1998 NEORX CORP MURINE MONOCLONAL ANTIBODY (NR-LU-
10)/STREPTAVIDIN CONJUGATE, BIOTIN-
GALACTOSE-HUMAN SERUM ALBUMIN,
YTTRIUM-Y-90-DOTA-BIOTIN
### I II 3/24/1998 SMITHKLINE BEECHAM CLENOLIXIMAB [CHIMERIC (MACAQUE/HUMAN)
PHARMACEUTICALS MONOCLONAL ANTIBODY (SB-217969) (CHO
CELLS, SMITHKLINE BEECHAM) TO CD4]
### I II 4/15/1998 GENMAB AS HUMAN MONOCLONAL ANTIBODY TO CD4
(ZANOLIMUNAB)
### I V 12/2/1997 UNIVERSITY BRITISH COLUMBIA MS/MRI RESEARCH GROUP AT THE UNIVERSITY
OF BRITISH COLUMBIA
### I II 5/7/1998 DIAMYD THERAPEUTICS AB RECOMBINANT HUMAN GLUTAMIC ACID
DECARBOXYLASE (RHGAD65)
### I II 8/20/1998 BIOGEN IDEC INC IDEC-114 (GALIXIMAB);CHEMERIC
(MACAQUE/HUMAN) MONOCLONAL ANTIBODY
TO CD80 (B7.1)
### I II 11/4/1998 NEORX CORP INDIUM-IN-111 RADIOLABELED HUMANIZED MAB
SINGLE CHAIN FV/STREPTAVIDIN FUSION
PROTEIN (HUNRLU10 SCFV/SA), BIOTIN-
GALACTOSE (SYNTHETIC), IN-111/Y-90-DOTA-
BIOTIN
### I II 1/8/1999 PROTEIN DESIGN LABORATORIES INC HUMANIZED MONOCLONAL ANTIBODY (HU1D10)
TO HLA-DR.
### A II 4/9/1999 HYCLONE LABS INC HYCLONE PROTEIN FREE MEDIA AND
CHEMICALLY DEFINED MEDIA PRODUCTS
### I II 5/15/1999 ABGENIX INC HUMAN MONOCLONAL ANTIBODY (ABX-EGF) TO
EPIDERMAL GROWTH FACTOR RECEPTOR
### I II 6/4/1999 ABGENIX INC BULK PURIFIED MURINE MONOCLONAL
ANTIBODY (ABX-CBL) TO BLAST CELLS
### I II 6/30/1999 LONZA BIOLOGICS PLC TOSITUMOMAB [MURINE MONOCLONAL
ANTIBODY (B1) AGAINST B LYMPHOCYTES
(CD20)]
### I II 10/6/1999 MEDAREX INC MURINE MONOCLONAL ANTIBODY (ALPHA
CTLA4) TOCTLA4
### I II 11/9/1999 GENENTECH INC DORNASE ALFA INHALATION SOLUTION
(GENENTECH)
### I V 1/13/2000 GENETICS INSTITUTE INC GENETICS INSTITUTE, INCORPORATED,
ANDOVER, MASSACHUSETTS CLINICAL
FILL/FINISH FACILITY
### I V 12/28/1999 CANCER AND LEUKEMIA GROUP B CANCER AND LEUKEMIA GROUP B (CALGB)
### I II 6/29/2000 MDS NORDION YTTRIUM - Y - 90 CHLORIDE STERILE SOLUTION
### I II 9/20/2000 BIOGEN IDEC INC HUMANIZED MONOCLONAL ANTIBODY (IDEC-
131) (CHO CELLS, IDEC) TO CD40L (CD 154)
### A II 9/18/2000 FRED HUTCHINSON CANCER MURINE MONOCLONAL ANTIBODY (BC8) TO
RESEARCH CENTER CD45
Page 596
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 10/18/2000 MDS NORDION YTTRIUM-Y-90 CHLORIDE (FISSION)
### I II 1/31/2001 EMD MILLIPORE CORP RETROPORE MEMBRANE AND VIRESOLVE
NORMAL FLOW RETROVIRUS DEVICES
### I II 3/13/2001 MEDIMMUNE LLC HUMANIZED MONOCLONAL ANTIBODY (MEDI-
522) TO THE VITRONECTIN (ALPHA-5 BETA-3)
RECEPTOR
### I II 4/2/2001 AMGEN INC HUMAN MONOCLONAL ANTIBODY (MDX-015)
(SP2/0,- AG14 CELLS, MEDAREX) TO IL15
### I II 4/30/2001 LONZA BIOLOGICS PLC BULK PURIFIED HUMANIZED MONOCLONAL
ANTIBODY (H5G1-1)(NSO CELLS. LONZA) TO C5
### I II 8/6/2001 NEKTAR THERAPEUTICS METHOXYPOLY (ETHYLENE GLYCOL)-
SUCCINIMIDYL BUTANOATE, MW 30,000
(MSBA30K)
### I II 12/20/2001 FRED HUTCHINSON CANCER HUMAN MONOCLONAL ANTIBODY (ABX-MA1) TO
RESEARCH CENTER MUC-18
### I II 2/25/2002 CHEMICON INTERNATIONAL MURINE MONOCLONAL ANTIBODY (T10B9-1A31)
TO T CELLS
### I II 2/28/2002 VIRON THERAPEUTICS SERINE PROTEINASE INHIBITOR-1 (CHO CELLS,
BIOVEST INTERNATIONAL)
### I II 10/4/2000 VIVENTIA BIOTECH INC GELONIN, RECOMBINANT (E. COLI)
### I II 4/17/2002 BRISTOL MYERS SQUIBB CO HUMAN MONOCLONAL ANTIBODY (MDX-060) TO
CD30
### I II 9/6/2002 WYETH PHARMACEUTICALS INC BONE MORPHOGENETIC PROTEIN-2 (HUMAN,
RECOMBINANT, CHO CELLS, WYETH)
### I II 12/9/2002 MEDAREX INC HUMAN MONOCLONAL ANTIBODY (MDX-070) TO
PROSTATE SPECIFIC MEMBRANE ANTIGEN
### I II 6/24/2003 MEDAREX INC HUMAN MONOCLONAL ANTIBODY (MDX-214) TO
THE EPIDERMAL GROWTH FACTOR RECEPTOR
(EGFR)
### I II 9/15/2003 FRED HUTCHINSON CANCER MURINE MONOCLONAL ANTIBODY (9.3) TO CD-
RESEARCH CENTER 28
### I II 9/22/2003 MEDAREX INC HUMAN MONOCLONAL ANTIBODY (MDX-067) TO
HEPARANASE
### I II 10/15/2003 MDS NORDION YTTRIUM (Y-90) CHLORIDE (FISSION)
### I II 3/15/2004 ELI LILLY AND CO MDX-068 (HUMANIZED ANTI-B-AMYLOID
MONOCLONAL ANTIBODY)
### A II 8/5/2005 RIOCARE INDIA PRIVATE LTD SIMETHICONE USP
### A II 8/5/2005 RIOCARE INDIA PVT LTD DIMETHICONE USP
### A II 8/5/2005 RIOCARE INDIA PVT LTD SIMETHICONE EMULSION USP
### I II 8/18/2005 ZHEJIANG HISUN PHARMACEUTICAL CO FAMCICLOVIR (NON-STERILE A
LTD PHARMACEUTICAL INGREDIENT)
### A II 8/18/2005 DELMAR CHEMICALS INC (R)-BAP L-MA
### A II 8/19/2005 ZHEJIANG HISUN PHARMACEUTICAL CO LOSARTAN POTASSIUM USP
LTD
### I III 8/15/2005 ADHESIVES RESEARCH INC MA-24B ADHESIVE
Page 597
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 8/15/2005 ADHESIVES RESEARCH INC HY-9 ADHESIVE
### I III 8/15/2005 ADHESIVES RESEARCH INC HY-10 ADHESIVE
### A II 8/23/2005 CATALENT PHARMA SOLUTIONS LLC LORATADINE SOFTGELS (10 MG)
### I II 8/24/2005 SHANDONG LUNAN BETTER ZOLPIDEM TARTRATE (NON-STERILE BULK
PHARMACEUTICAL CO LTD FORM)
### A IV 8/24/2005 GATTEFOSSE SAS PANCOGENE® MARIN
### I II 8/24/2005 DR REDDYS LABORATORIES LTD DISODIUM PAMIDRONATE
### A II 8/25/2005 CADILA HEALTHCARE LTD TOPIRAMATE USP
### A II 8/25/2005 CIPLA LTD PRAMIPEXOLE DIHYDROCHLORIDE
MONOHYDRATE USP
### A II 8/25/2005 CADILA HEALTHCARE LTD LORATADINE USP
### A II 9/29/2005 BITOLEA SPA CHIMICA ECOLOGICA KETOENAMINE
### I II 8/8/2005 ACS DOBFAR SPA CLINDAMYCIN HYDROCHLORIDE
### A II 8/8/2005 ACS DOBFAR SPA CLINDAMYCIN PHOSPHATE
### A II 8/15/2005 ERREGIERRE SPA ARIPIPRAZOLE USP-EP
### A II 8/16/2005 ERREGIERRE SPA BUTENAFINE HYDROCHLORIDE
### I II 8/26/2005 CATALENT PHARMA SOLUTIONS LLC R115866 SOFTGELS
### I II 8/24/2005 ZHEJIANG HISUN PHARMACEUTICAL CO PRAVASTATIN SODIUM (AMORPHOUS, NON-
LTD STERILE A PHARMACEUTICAL INGREDIENT)
### I II 8/25/2005 ZHEJIANG HISUN PHARMACEUTICAL CO TAZOBACTAM SODIUM (NON-STERILE A
LTD PHARMACEUTICAL INGREDIENT)
18711 A III 8/29/2005 WACKER CHEMIE AG VINNAPAS(R) B 100
### I III 8/25/2005 CODING PRODUCTS TTR-51524 THERMAL TRANSFER INK RIBBON
### A II 8/18/2005 AUROBINDO PHARMA LTD LAMIVUDINE USP
### A II 8/18/2005 AUROBINDO PHARMA LTD ZIDOVUDINE USP
### A II 8/30/2005 TORRENT PHARMACEUTICALS LTD VENLAFAXINE HYDROCHLORIDE USP
### A II 8/29/2005 TIANJIN TIANYAO PHARMACEUTICALS PREDNISOLONE USP BULK
CO LTD
### A II 8/29/2005 SCINOPHARM TAIWAN LTD TAMSULOSIN HYDROCHLORIDE USP
### A IV 8/31/2005 CARGILL POLYOLS LLC ERYTHRITOL 16956 (PHARMA EXCIPIENT
GRADE)
### A II 8/31/2005 ALEMBIC PHARMACEUTICALS LTD AZITHROMYCIN MONOHYDRATE USP
### A III 8/31/2005 NOVARTIS PHARMACEUTICALS CORP T-326 DRY POWDER INHALER DEVICE
### I II 8/23/2005 STRAINTITE DCX-8XX-MD-XX-XXX-XXX: 8-INCH NOMINAL
DIAMETER CLARIFICATION VESSEL FOR ONE-
TIME USE.
### A II 9/1/2005 FARMABIOS SPA CEFUROXIME SODIUM STERILE USP
### A II 8/31/2005 CIPLA LTD BICALUTAMIDE USP
### A III 9/1/2005 APTAR FRANCE SAS QUALITY CONTROL METHODS FOR APTAR
PACKAGING COMPONENTS
### I II 9/2/2005 NOVARTIS PHARMACEUTICALS CORP PULMOSPHERE(R) PLACEBO INHALATION
POWDER
### A II 8/31/2005 EVONIK REXIM NANNING L-METHIONINE (PHARMACEUTICAL INFUSION
PHARMACEUTICAL CO LTD GRADE)
### A II 8/31/2005 HIKMA PHARMACEUTICALS GLYCOPYRROLATE USP
Page 598
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 9/2/2005 NATIONAL INSTITUTES HEALTH 2-CYANO-3, 12-DIOXOOLEANA-1, 9(11)-DIEN-28-
NATIONAL CANCER INSTITUTE OIC ACID (CDDO)
### I III 9/7/2005 KUNSTSTOFFWERK KREMSMUNSTER 71.216.32 DP1S1 PP 28 CAPS T/E CRC WITH
GMBH SILICAGEL
### A IV 9/6/2005 DMV-FONTERRA EXCIPIENTS GMBH AND RESPITOSE(R) ML003
CO KG
### I II 9/7/2005 RESOLUTION CHEMICALS LTD DRONABINOL USP
### A II 9/9/2005 ALEMBIC PHARMACEUTICALS LTD LAMOTRIGINE USP
### I II 9/7/2005 HETERO LABS LTD DIDANOSINE
### A II 9/9/2005 ALEMBIC PHARMACEUTICALS LTD VENLAFAXINE HYDROCHLORIDE USP
### I IV 8/12/2005 SUNIL HEALTHCARE LTD EMPTY HARD GELATIN CAPSULES
### A III 9/1/2005 POLYONE CORP CC10037686BG
### A III 9/1/2005 POLYONE CORP CC10037779BG
### A III 9/8/2005 SABIC INNOVATIVE PLASTICS CYCOLOY™ RESINS
### I II 9/9/2005 PROMETHEUS LABORATORIES INC AZATHIOPRINE 50 MG TABLETS AND PLACEBO
TABLETS
### A II 9/8/2005 BCN PEPTIDES SA OCTREOTIDE ACETATE
### I IV 9/9/2005 OLOGY BIOSERVICES INC GELSITE(R) POLYMER, A PHARMACEUTICAL
EXCIPIENT FOR MUCOSAL DELIVERY
APPLICATIONS.
### A II 9/9/2005 INFAR SA 5-AMINOSALICYLIC ACID I (MESALAMINE)
### I II 9/9/2005 MITSUBISHI TANABE PHARMA CORP MP-513 DRUG SUBSTANCE
### A III 9/2/2005 ELM PLASTIC GMBH PLASTIC DOSING PIPETTES AND ACCESSORY
### A IV 8/10/2005 UNGERER AND CO NATURAL PEPPERMINT EXT. FN-2356
### I II 9/8/2005 QUIMICA SINTETICA SA IRBESARTAN
### I IV 9/2/2005 DAVID MICHAEL AND CO INC ARTIFICIAL CREAM FLAVOR #20761
### A IV 9/2/2005 DAVID MICHAEL AND CO INC ARTIFICIAL CREAM FLAVOR #12034
### A IV 9/2/2005 DAVID MICHAEL AND CO INC ARTIFICIAL CREAM FLAVOR #20844
### A IV 9/2/2005 DAVID MICHAEL AND CO INC ARTIFICIAL VANILLA FLAVOR #15448
### A IV 9/2/2005 DAVID MICHAEL AND CO INC ARTIFICIAL VANILLA FLAVOR #1119
### A IV 9/2/2005 DAVID MICHAEL AND CO INC ARTIFICIAL VANILLA CREAM FLAVOR #24549
### A IV 9/2/2005 DAVID MICHAEL AND CO INC MICHAEL-THERMICS(R) ARTIFICIAL VANILLA
FLAVOR #16618
### A IV 9/2/2005 DAVID MICHAEL AND CO INC ARTIFICIAL VANILLA CREAM FLAVOR #20397
### A II 9/13/2005 JUBILANT GENERICS LTD SIMVASTATIN USP
### A II 9/12/2005 GLENMARK PHARMACEUTICALS LTD ADAPALENE USP
### I II 8/26/2005 MOEHS IBERICA SL TRIAMTERENE
### I II 9/12/2005 TEVA PHARMACEUTICAL INDUSTRIES TERBINAFINE HYDROCHLORIDE
LTD
### I II 9/12/2005 GLENMARK PHARMACEUTICALS LTD TELMISARTAN
### A II 9/13/2005 BIOCON LTD FLUVASTATIN SODIUM
### A III 9/1/2005 POLYONE CORP CC10064753BG
### A III 9/1/2005 POLYONE CORP CC10069184BG
### I III 9/8/2005 AMPACET CORP AMPACET 191423-K GREY 423
### I III 9/8/2005 AMPACET CORP AMPACET 140456-K ORANGE 456
Page 599
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 9/8/2005 AMPACET CORP AMPACET 181060-K BROWN 060
### I III 9/8/2005 AMPACET CORP AMPACET 162057-K BLUE 057
### I III 9/8/2005 AMPACET CORP AMPACET 191422-K BLACK 422
### A III 9/8/2005 AMPACET CORP 7188175 WHITE POLYETHYLENE MASTERBATCH
Page 602
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 10/14/2005 NINGBO SMART PHARMACEUTICAL CO DICLOFENAC SODIUM
LTD
### I II 10/14/2005 AMINO CHEMICALS LTD VENLAFAXINE HYDROCHLORIDE
### I III 10/16/2006 RKW AG RHEINISCHE POLYETHYLENE-FILM K460/50
KUNSTSTORFFWERKE
### I IV 10/15/2005 DURECT CORP CELLULOSE ACETATE BUTYRATE (CAB)-381-
20BP, ETHANOL WASHED
### A IV 10/15/2005 DURECT CORP PHARMACEUTICAL GRADE SAIB (SUCROSE
ACETATE ISOBUTYRATE)
### A V 10/3/2005 MEDTRONIC VASCULAR HOLDINGS CLINICAL AND NON-CLINICAL STUDIES FOR ABT-
UNLTD CO 578 (ZOTAROLIMUS)
### I II 10/18/2005 QILU TIANHE PHARMACEUTICAL CO LTD TAZOBACTAM ACID (INTERMEDIATE, NON-
STERILE BULK)
### I III 10/14/2005 GERRESHEIMER REGENSBURG GMBH HANDIHALER(R) DEVICE
### I II 10/1/2005 AUROBINDO PHARMA LTD CEFUROXIME SODIUM (STERILE) USP
### A II 10/18/2005 JOHNSON MATTHEY PHARMACEUTICAL TETRAHYDROCANNABINOL (THC) IN ETHANOL
MATERIALS
### A II 10/14/2005 WANBURY LTD METFORMIN HYDROCHLORIDE DC GRADE - 90%
Page 605
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 10/30/2005 POLYMED THERAPEUTICS INC IRINOTECAN HYDROCHLORIDE TRIHYDRATE
(NON-STERILE BULK) DRUG SUBSTANCE
### I III 11/7/2005 NYPRO INC OCUMETER(R) PLUS VIAL
### A II 11/25/2005 DIVIS LABORATORIES LTD TAMSULOSIN HYDROCHLORIDE
### I II 11/25/2005 RESOLUTION CHEMICALS LTD CABERGOLINE DRUG SUBSTANCE
### A II 11/23/2005 AUROBINDO PHARMA LTD RIBAVIRIN USP
### A II 11/16/2005 AUROBINDO PHARMA LTD ZOLPIDEM TARTRATE USP
### I II 11/28/2005 DSM NUTRITIONAL PRODUCTS LTD 5-FLUOROURACIL
### I II 4/8/2007 JIANGSU ZHONGDAN PHARMACEUTICAL NABUMETONE
CO LTD
### A II 11/28/2005 ACS DOBFAR SPA CEFOTETAN DISODIUM (STERILE BULK)
### A II 11/28/2005 GRANULES INDIA LTD COMPRESSO PAP 90 CPL
### A II 11/18/2005 PRIME EUROPEAN THERAPEUTICS SPA RITALINIC ACID
(EUTICALS SPA)
### A II 11/23/2005 AUROBINDO PHARMA LTD FLUOXETINE HYDROCHLORIDE USP
### A II 11/29/2005 DERIVADOS QUIMICOS SAU BUTOCONAZOLE NITRATE
### I II 11/28/2005 TEVA PHARMACEUTICAL INDUSTRIES ZOLPIDEM TARTRATE
LTD
### I II 11/28/2005 TEVA PHARMACEUTICAL INDUSTRIES VENLAFAXINE HYDROCHLORIDE
LTD
### A II 11/24/2005 QUIMICA SINTETICA SA MELOXICAM
### A II 11/28/2005 CHUNGHWA CHEMICAL SYNTHESIS AND TACROLIMUS
BIOTECH CO LTD
### I II 8/4/2005 CADILA PHARMACEUTICALS LTD ZOLPIDEM TARTRATE
### A II 11/30/2005 CATALENT PHARMA SOLUTIONS LLC SANDIMMUNE 25 MG AND 100 MG SOFTGELS
### A II 11/28/2005 TEVA PHARMACEUTICAL INDUSTRIES METHYLERGONOVINE MALEATE USP
LTD
### I II 11/28/2005 IVAX PHARMACEUTICALS SRO MYCOPHENOLATE MOFETIL USP
### I II 11/30/2005 SUMITOMO DAINIPPON PHARMA CO LTD SM-5887 (AMRUBICIN HYDROCHLORIDE)
### I II 11/30/2005 SUMITOMO CHEMICAL CO LTD PBL (A STARTING MATERIAL FOR
MANUFACTURING DRUG SUBSTANCES)
### I II 12/2/2005 BELCHER PHARMACEUTICALS INC OMEPRAZOLE PELLETS (8.5% W/W)
### A III 12/2/2005 JSR CORP STYRENE ISOPRENE BLOCK COPOLYMER (JSR
SIS)
### A II 12/2/2005 VALEANT PHARMACEUTICALS NORTH METFORMIN AQ 1000 MG EXTENDED RELEASE
AMERICA LLC TABLETS
### A II 11/28/2005 SHANDONG NEW TIME ISOFLURANE (NON-STERILE BULK)
PHARMACEUTICAL CO LTD
### I II 12/1/2005 EURAND INC EUR-1038 MODIFIED RELEASE CAPSULES
### A II 11/25/2005 NIACET BV CALCIUM ACETATE
### A II 11/30/2005 OLON SPA ALPHA LIPOIC ACID
### I IV 11/28/2005 COGNIS GMBH PLANTACARE 2000 UP
### A II 12/4/2005 DIVIS LABORATORIES LTD GABAPENTIN USP
### I II 12/5/2005 KYOWA HAKKO BIO CO LTD D-SERINE (BULK SUBSTANCE)
Page 606
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/5/2005 TEVA PHARMACEUTICAL INDUSTRIES DEXRAZOXANE (ICRF-187)
LTD
### I II 11/11/2005 GE HEALTHCARE BIO SCIENCES CORP BF-1400 FILM CELLBAG(R)
### A III 12/6/2005 EMS CHEMIE NORTH AMERICA INC GRIVORY G21 NATURAL
### I II 12/7/2005 TEVA PHARMACEUTICALS INDUSTRIES ZIPRASIDONE HYDROCHLORIDE
LTD
### A II 11/28/2005 RL FINE CHEM PVT LTD LORAZEPAM
### I II 12/5/2005 CHANGZHOU QIANHONG BIO PHARMA HEPARIN SODIUM USP
CO LTD
### I II 12/2/2005 RELIABLE BIOPHARMACEUTICAL LLC PROTAMINE SULFATE USP
### A II 12/5/2005 WAVELENGTH ENTERPRISES LTD IMIQUIMOD
### I II 12/7/2005 RANBAXY LABORATORIES LTD REPAGLINIDE USP
19011 I II 12/7/2005 RANBAXY LABORATORIES LTD CEFDITOREN PIVOXIL DRUG SUBSTANCE
### I II 12/7/2005 RANBAXY LABORATORIES LTD CEFDITOREN SODIUM INTERMEDIATE DRUG
SUBSTANCE
### A II 11/28/2005 AUROBINDO PHARMA LTD BENAZEPRIL HYDROCHLORIDE USP
### A II 12/8/2005 SUN PHARMACEUTICAL INDUSTRIES DESLORATADINE
LTD
### I II 12/13/2005 GADOR SA ZALEPLON
### I II 12/6/2005 INTERNATIONAL MEDICATION SYSTEMS SODIUM NITRITE INJECTION USP, 30 MG / ML, 10
LTD ML
### A II 11/21/2005 SI GROUP ALBE-TAB® IBUPROFEN 90
### I II 12/6/2005 LABORATOIRES FOURNIER SA FENOFIBRATE SPRAY GRANULATION
INTERMEDIATE
### A II 12/8/2005 HIKAL LTD TRIPROLIDINE HYDROCHLORIDE API
### A II 1/4/2006 UNIQUE CHEMICALS DICLOFENAC DIETHYAMINE
### I II 12/5/2005 SMRUTHI ORGANICS LTD NORFLOXACIN USP
### A II 12/9/2005 NOF CORP DIERUCOYL PHOSPHATIDYLCHOLINE (DEPC)
### A III 12/9/2005 3M DRUG DELIVERY SYSTEMS DIV MOMETASONE & FORMOTEROL COMBINATION
PRODUCT PMDI ACTUATOR
### I II 12/14/2005 ESTEVE QUIMICA SA MEMANTINE HYDROCHLORIDE
### A II 12/13/2005 ALCAMI WISCONSIN CORP ANASTROZOLE
### A II 12/10/2005 AKSHAT PHARMA PRIVATE LTD GLYCOPYRROLATE USP
### I III 12/5/2005 ROLLPRINT PACKAGING PRODUCTS INC RPP #36-1210
### A II 12/13/2005 MICRONISIERUNGS KONTOR OBERROT CICLESONIDE, MICRONIZED (ITEM NO. 37)
GMBH
### I II 12/9/2005 ALPHARMA APS TOBRAMYCIN BASE USP (NON-STERILE BULK)
### I II 12/9/2005 ALPHARMA APS TOBRAMYCIN SULPHATE USP (NON-STERILE
BULK)
### A II 12/14/2005 PFIZER HEALTHCARE INDIA PVT LTD PIPERACILLIN
### A II 12/15/2005 TEVA PHARMACEUTICAL INDUSTRIES LINEZOLID
LTD
### A II 12/15/2005 TEVA PHARMACEUTICAL INDUSTRIES LEVETIRACETAM
LTD
Page 607
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/16/2005 TEVA PHARMACEUTICAL INDUSTRIES ANASTROZOLE
LTD
### A II 12/13/2005 WANBURY LTD SERTRALINE HYDROCHLORIDE
### I II 12/17/2005 SUN PHARMACEUTICAL INDUSTRIES ZOLPIDEM TARTRATE DRUG SUBSTANCE
LTD
### A II 12/9/2005 AUROBINDO PHARMA LTD RITONAVIR USP
### I II 12/15/2005 RELIABLE BIOPHARMACEUTICAL CORP DALTEPARIN SODIUM
### A III 12/16/2005 NYPRO INC PROVENTIL(R) HFA (ALBUTEROL SULFATE)
INHALATION AEROSOL ACTUATOR & DUST CAP
### I II 12/15/2005 DAINIPPON SUMITOMO PHARMA CO LTD SMP-028
### A II 12/16/2005 AVANTI POLAR LIPIDS INC DSPE-PEG2000 MALEIMIDE
### I IV 12/19/2005 NOF CORP DSPE-PEG5000
### A II 12/1/2005 SECOND PHARMA CO LTD AMLODIPINE BESILATE
### I II 12/13/2005 CONCORD BIOTECH LTD SIMVASTATIN USP
### A II 12/19/2005 USV PRIVATE LTD ROPINIROLE HYDROCHLORIDE USP
### A II 11/30/2005 AUROBINDO PHARMA LTD QUINAPRIL HYDROCHLORIDE USP
### I II 12/22/2005 SUN PHARMACEUTICAL INDUSTRIES SERTRALINE HYDROCHLORIDE
LTD
### A II 12/16/2005 JUBILANT GENERICS LTD DONEPEZIL HYDROCHLORIDE
USP(ANHYDROUS FORM-1)
### I II 12/21/2005 SUN PHARMACEUTICAL INDUSTRIES GANCICLOVIR (INTERMEDIATE DRUG
LTD SUBSTANCE)
### A II 12/20/2005 PLIVA-LACHEMA AS IRINOTECAN HYDROCHLORIDE TRIHYDRATE
### I II 12/19/2005 RANBAXY LABORATORIES LTD LEVETIRACETAM
### I II 12/17/2005 MYTHEN SPA DEFEROXAMINE MESYLATE NT
### A II 12/19/2005 SCINOPHARM TAIWAN LTD GEMCITABINE HYDROCHLORIDE USP
### I II 12/19/2005 BRIDGE ORGANICS CO Z4124 FINAL INTERMEDIATE
### I III 12/6/2005 INDIAN PETROCHEMICALS CORP LTD POLYETHYLENE (PE) INDOTHENE 22FA002
### A II 12/8/2005 XINYU PHARMACEUTICAL CO LTD LINCOMYCIN HYDROCHLORIDE USP
### A III 12/6/2005 TECHNOFLEX CONTAINERS AND CLOSURE SYSTEM FOR
INJECTABLE SOLUTION AND DRUGS
### I II 12/21/2005 APOTEX PHARMACHEM INDIA PVT LTD ENALAPRIL MALEATE USP
### I III 12/22/2005 SYNTHETIC RUBBER TECHNOLOGIES RUBBER AND POLYMERIC COMPOUNDS
INC
### I II 12/21/2005 SUN PHARMACEUTICAL INDUSTRIES VALGANCICLOVIR HYDROCHLORIDE (NON-
LTD STERILE BULK)
### I II 12/22/2005 INTRALYTIX INC WPP-201, A BACTERIOPHAGE COCKTAIL FOR P.
AERUGINOSA, S. AUREUS, AND E. COLI
### A II 12/19/2005 SOFRADIM PRODUCTION PORCINE ATELOCOLLAGEN CPP
### A II 12/23/2005 EUTICALS INC METHYLPHENIDATE HYDROCHLORIDE USP
### I II 12/20/2005 ZHEJIANG HISOAR PHARMACEUTICAL CALCIUM POLYCARBOPHIL
CO LTD
### A III 12/22/2005 BIRGI SANAYI AS 1-30 ML COLOURLESS AMPOULES FOR
INJECTABLES MADE OF TUBULAR GLASS
Page 608
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 12/22/2005 BIRGI SANAYI AS 1-30 ML AMBER AMPOULES FOR INJECTABLES
MADE OF TUBULAR GLASS
### A III 12/22/2005 BIRGI SANAYI AS 2-30 ML COLOURLESS INJECTION VIALS MADE
OF TUBULAR GLASS
### A III 12/22/2005 BIRGI SANAYI AS 2-30 ML AMBER INJECTION VIALS MADE OF
TUBULAR GLASS
### A II 12/14/2005 ZHEJIANG HISUN PHARMACEUTICAL CO ACARBOSE USP
LTD
### A II 12/24/2005 APICORE US LLC GRANISETRON HYDROCHLORIDE
### A II 12/19/2005 AUROBINDO PHARMA LTD ONDANSETRON HYDROCHLORIDE USP
### I II 12/22/2005 ZHEJIANG HISUN PHARMACEUTICAL CO TACROLIMUS (NON-STERILE A
LTD PHARMACEUTICAL INGREDIENT)
### A II 12/21/2005 3M PURIFICATION INC LIFEASSURE™ PDA AND PNA SERIES FILTER
PRODUCTS
### I II 12/21/2005 CUNO INC BIOLIFE(TM) FILTER PRODUCTS
### A II 12/27/2005 VIVIMED LABS ALATHUR PRIVATE LTD TRICLOSAN USP
### I II 12/28/2005 RANBAXY LABORATORIES LTD CILOSTAZOL DRUG SUBSTANCE
### A III 12/22/2005 POLYONE CORP CC00018519DR COLORANT PRODUCT
### A II 12/15/2005 HUBEI BIOCAUSE HEILEN GRANISETRON HYDROCHLORIDE, NON-STERILE
PHARMACEUTICAL CO LTD BULK DRUG SUBSTANCE
### A II 12/30/2005 SIGMA ALDRICH MANUFACTURING LLC N-DODECYL BETA-D-MALTOSIDE
### A II 12/30/2005 LUPIN LTD LEVETIRACETAM USP
### I II 1/3/2006 NV ORGANON FENTANYL CITRATE
### A II 12/16/2005 FINE ORGANICS LTD KETAMINE HYDROCHLORIDE
### A II 12/27/2005 LUPIN LTD DESLORATADINE USP
### A II 12/30/2005 NAVINTA LLC ROPIVACAINE
### A II 1/4/2006 TRIFARMA SPA FOSCARNET SODIUM
### A III 1/2/2006 HINDALCO INDUSTRIES LTD KOLLUR STRIP PACKAGING ALUMINIUM FOIL
WORKS
### A III 1/2/2006 HINDALCO INDUSTRIES LTD KOLLUR BLISTER PACKAGING ALUMINIUM FOIL
WORKS
### A II 12/24/2005 AUROBINDO PHARMA LTD ESCITALOPRAM OXALATE USP
### I II 1/3/2006 BASF SE TAZAROTENE
### A II 12/20/2005 TEVA PHARMACEUTICAL INDUSTRIES ERGONOVINE MALEATE
LTD
### I II 12/20/2005 SHANDONG NEW TIME SEVOFLURANE (NON-STERILE BULK FORM)
PHARMACEUTICAL CO LTD
### A II 1/6/2006 SUVEN LIFE SCIENCES LTD ENTACAPONE
### A II 1/6/2006 AMRI RENSSELAER INC SUB ALBANY VORINOSTAT DRUG SUBSTANCE
MOLECULAR RESEARCH INC
### I II 1/3/2006 EXOPHARM CO LTD VINORELBINE TARTRATE (NON-STERILE BULK
DRUG SUBSTANCE)
### A II 1/6/2006 HETERO DRUGS LTD PERINDOPRIL TERT-BUTYLAMINE
### A II 1/5/2006 TIANJIN TIANYAO PHARMACEUTICALS TRIAMCINOLONE ACETONIDE USP
CO LTD
Page 609
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 1/10/2006 MYLAN LABORATORIES LTD SILDENAFIL CITRATE USP
### A II 1/10/2006 MYLAN LABORATORIES LTD RIZATRIPTAN BENZOATE USP
### I II 1/10/2006 EVONIK TECHNOCHEMIE GMBH D-PENICILLAMINE
### A III 1/10/2006 3M DRUG DELIVERY SYSTEMS COTRAN™ 9719 POLYETHYLENE FILM
### I III 1/10/2006 3M DRUG DELIVERY SYSTEMS SCOTCHPAK(TM) 9680, 2-MIL POLYESTER FILM
LAMINATE
### A IV 10/28/2005 EVONIK NUTRITION AND CARE GMBH RESOMER® R FOR PHARMACEUTICAL
APPLICATIONS
### A IV 10/28/2005 EVONIK NUTRITION AND CARE GMBH RESOMER® RG FOR PHARMACEUTICAL
APPLICATIONS
### I II 1/10/2006 HIKAL LTD LEVETIRACETAM API
### A II 12/31/2005 LUPIN LTD ESCITALOPRAM OXALATE USP
### A II 1/6/2006 AUROBINDO PHARMA LTD CARVEDILOL USP
### I II 1/16/2006 ELAN DRUG DELIVERY INC N1504 NANOCRYSTAL(R) COLLOIDAL
DISPERSION - STERILE INTERMEDIATE
### I III 1/13/2006 SENAWANG LAMINATING SL5825A, CLEAR LAMINATE FOR MEDICAL
TECHNOLOGIES SDN BHD PACKAGING
### A II 1/12/2006 MACFARLAN SMITH LTD BUPRENORPHINE HYDROCHLORIDE
19110 A III 1/13/2006 NAIGAI GLASS INDUSTRY CO LTD AMPOULE
19111 A II 1/12/2006 YUNNAN HANDE BIO-TECH CO LTD PACLITAXEL DRUG SUBSTANCE ISOLATED
FROM TAXUS CANADENSIS
19112 I II 1/18/2006 N S CHEMICALS PARA CHLORO META XYLENOL (PCMX), USP
19113 A II 1/18/2006 APOTEX PHARMACHEM INC MOEXIPRIL HYDROCHLORIDE USP
19114 I II 12/23/2005 BIOIBERICA SA CHONDROITIN SULFATE SODIUM SHARK
INJECTABLE GRADE
19115 I II 1/19/2006 NEULAND LABORATORIES LTD FLUTICASONE PROPIONATE PH.EUR
19116 A III 12/15/2005 BASELL POLIOLEFINE ITALIA SRL PURELL ACP 6541 A (POLYETHYLENE HIGH
DENSITY)
19117 I II 1/19/2006 AREVIPHARMA GMBH TRAMADOL HYDROCHLORIDE
19118 I III 1/20/2006 SHINKO CHEMICAL CO LTD EYEDROP CONTAINER 6
19119 A II 1/16/2006 MOEHS IBERICA SL MICRONIZED FENOFIBRATE & FENOFIBRATE
### I III 1/6/2006 AMPACET CORP 100664-K RELEASY 64 POLYETHYLENE
MASTERBATCH
### I III 1/6/2006 AMPACET CORP 100665-K RELEASY 65 POLYPROPYLENE
MASTERBATCH
### A III 1/6/2006 AMPACET CORP 11447-K BLOMITE 47 POLYETHYLENE
MASTERBATCH
### A III 1/6/2006 AMPACET CORP 11343-K PROMITE- 43
### A III 1/13/2006 KIRCHNER SIMON AND CO GMBH O28L89070 TAMPER EVIDENT CAPS PP28 MADE
OF PP WITH HOLE
### A III 1/13/2006 KIRCHNER SIMON AND CO GMBH OV2889070 TAMPER EVIDENT CAP PP 28 MADE
OF PP WHITE WITH TAMPER EVIDENT RING
MADE OF PP BLUE AND INJECTED JOINT MADE
OF TPE
### I II 1/23/2006 XIAN LIJUN PHARMACEUTICAL CO LTD ERYTHROMYCIN THIOCYANATE
Page 610
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I IV 1/19/2006 ALBERMARLE CORP AZONE(R), AN INA INGREDIENT
### A II 1/24/2006 CYALUME SPECIALTY PRODUCTS INC CHLORHEXIDINE GLUCONATE 20% SOLUTION,
USP
### A II 1/25/2006 SUN PHARMACEUTICAL INDUSTRIES DONEPEZIL HYDROCHLORIDE USP
LTD
### I III 1/13/2006 EXEMPLAR PHARMACEUTICALS LLC HFA 134A PLACEBO
### A II 1/25/2006 CIPLA LTD LEVALBUTEROL HYDROCHLORIDE USP
### I II 1/26/2006 KATAYAMA SEIYAKU CO LTD LOMEFLOXACIN HYDROCHLORIDE
### I II 1/22/2006 WORLD JIANGSU INDUSTRY CO LTD BACITRACIN ZINC USP (NON-STERILE DRUG
SUBSTANCE)
### I II 1/22/2006 JIANGSU SUNNY HEALTH INDUSTRY CO GALANTAMINE HYDROBROMIDE (NON-STERILE
LTD DRUG SUBSTANCE)
### I IV 1/26/2006 FONA INTERNATIONAL INC 833.051 N-C NATURAL & ARTIFICIAL COFFEE
FLAVOR
### I IV 1/26/2006 FONA INTERNATIONAL INC 861.094 HONEY FLAVOR, ARTIFICIAL
### I IV 1/26/2006 FONA INTERNATIONAL INC 857.080 NATURAL GRAPEFRUIT EXTRACT
(WONF)
### A II 1/26/2006 EVONIK NUTRITION AND CARE GMBH LISINOPRIL DIHYDRATE
### A II 1/25/2006 SCINOPHARM TAIWAN LTD LETROZOLE
### I II 1/27/2006 NEKTAR THERAPEUTICS PEG2MAL40K
### A II 1/31/2006 GLENMARK PHARMACEUTICALS LTD OLMESARTAN MEDOXOMIL, USP
### A II 1/26/2006 CHENGDA PHARMACEUTICALS CO LTD LEVOCARNITINE USP
### I II 1/20/2006 WANBURY LTD GLUCOSAMINE HYDROCHLORIDE
### A IV 1/30/2006 NITTO DENKO CORP PHARMACEUTICAL ADHESIVE FOR
TRANSDERMAL SYSTEM: AV-V SOLUTION
### A III 2/1/2006 BORMIOLI PHARMA SPA PET BOTTLE 100 ML-FI8095
### A III 2/1/2006 BORMIOLI PHARMA SPA TE CLOSURE
### A III 2/1/2006 BORMIOLI PHARMA SPA CHILD RESISTANT CLOSURE 28 MM: "CHILD
RESISTANT PLUS"
### A II 2/2/2006 AMINO CHEMICALS LTD BENAZEPRIL HYDROCHLORIDE
### A II 1/31/2006 ANQIU LUAN PHARMACEUTICAL CO LTD ACETAMINOPHEN, DC 90%
### A IV 2/3/2006 EVONIK CORP BIODEGRADABLE POLYMER EXCIPIENTS
### A II 2/3/2006 ALCAMI WISCONSIN CORP FP-059 (FOMEPIZOLE) DRUG SUBSTANCE
### A II 1/30/2006 AUROBINDO PHARMA LTD PAROXETINE HYDROCHLORIDE (HEMIHYDRATE)
USP
### A II 1/30/2006 AUROBINDO PHARMA LTD BUPROPION HYDROCHLORIDE USP
### I III 1/31/2006 NYPRO INC CONTAINER CLOSURE SYSTEM OF THE DRY
POWDER INHALER (DPI)
### A II 1/19/2006 CADILA PHARMACEUTICALS LTD CELECOXIB USP
### A III 2/4/2006 P CHHOTALAL MANUFACTURERS PLASTIC BOTTLES (MADE OF HDPE, LDPE,
EXPORTERS MDPE & PP) ALUMINUM COLLAPSIBLE TUBES,
ALUMINUM AEROSOL CANS, ALUMINUM
PHARMACEUTICAL FOIL AND POLYAL TAPE
### I II 2/6/2006 NEKTAR THERAPEUTICS PEG2NHS40KP
### I II 2/3/2006 LIMTECH CARBONATE INC LITHIUM CARBONATE, USP GRADE
Page 611
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 1/30/2006 CHONGQING UNITED PHARMACEUTICAL PACLITAXEL DRUG SUBSTANCE
CO LTD
### A II 2/2/2006 FERMION OY QUETIAPINE FUMARATE A PHARMACEUTICAL
INGREDIENT
### I II 2/8/2006 SUN PHARMACEUTICAL INDUSTRIES CARISOPRODOL USP (A SUBSTANCE)
LTD
### A II 2/8/2006 SUN PHARMACEUTICAL INDUSTRIES CEPHALEXIN USP (COMPACTED)
LTD
### I II 2/8/2006 NIPPON CHEMIPHAR CO LTD NC-2300 DRUG SUBSTANCE
### A V 12/23/2005 EIRGENIX INC CGMP MANUFACTURING FACILITY FOR
PRODUCTION OF BIOPHARMACEUTICALS FOR
CLINICAL TRIALS
### A IV 10/20/2005 SASOL GERMANY GMBH LIPOXOL(R) MED
### I III 2/10/2006 GRAHAM PACKAGING CO LP PLASTIC CONTAINERS
### A II 2/8/2006 ACS DOBFAR SPA ACID CEFOTETAN
### I II 2/10/2006 CADILA HEALTHCARE LTD OLANZAPINE
### A II 2/9/2006 EXCELLA GMBH AND CO KG ADAPALENE
### A II 2/13/2006 ALCAMI WISCONSIN CORP LETROZOLE, USP
### I II 3/14/2006 CARDIOME DEVELOPMENT AG RSD1235 DRUG SUBSTANCE
### I IV 2/14/2006 FONA INTERNATIONAL INC 805.124 N-C ARTIFICIAL BANANA FLAVOR
### I IV 2/14/2006 FONA INTERNATIONAL INC 936.420 MASKING AGENT FLAVOR, ARTIFICIAL
### I IV 2/14/2006 FONA INTERNATIONAL INC 875.017 MENTHOL FLAVOR, NATURAL
### I IV 2/14/2006 FONA INTERNATIONAL INC 915.010 N-C ARTIFICIAL FRESH STRAWBERRY
FLAVOR
### A II 2/14/2006 ALCHYMARS ICM SM PRIVATE LTD CLINDAMYCIN HYDROCHLORIDE, USP
### A II 2/10/2006 CAMBREX KARLSKOGA AB BUPIVACAINE BASE
### A II 2/14/2006 SUN PHARMACEUTICAL INDUSTRIES PAROXETINE HYDROCHLORIDE HEMIHYDRATE
LTD USP
### A II 2/14/2006 DR REDDYS LABORATORIES LTD RIZATRIPTAN BENZOATE USP
### I II 8/7/2006 CIPLA LTD ALFUZOSIN HYDROCHLORIDE
### A II 3/9/2006 CIPLA LTD FAMCICLOVIR USP
### I II 5/18/2006 CIPLA LTD DESLORATADINE
### I II 2/17/2006 CIPLA LTD LEVO SALBUTAMOL SULPHATE
### A IV 2/10/2006 BASF SE KOLLICOAT® PROTECT
### I II 2/8/2006 EXOPHARM CO LTD IDARUBICIN HYDROCHLORIDE, USP NON-
STERILE BULK DRUG SUBSTANCE
### A II 1/31/2006 AUROBINDO PHARMA LTD RABEPRAZOLE SODIUM
### I III 2/10/2006 FARMASERVICE SRL SQUARE HDPE BOTTLE, 95 ML
### I III 2/10/2006 FARMASERVICE SRL SQUARE HDPE BOTTLE, 25 ML
### I III 2/10/2006 FARMASERVICE SRL SQUARE HDPE BOTTLE, 165 ML
### A II 2/17/2006 VISTIN PHARMA AS METFORMIN HYDROCHLORIDE
### A II 10/25/2005 JIANGXI HENGXIANG PHARMCEUTICAL ISOTRETINOIN (NON-STERILE BULK FORM)
TECHNOLOGY CO LTD
### I II 2/21/2006 DR REDDYS LABORATORIES LTD ESOMEPRAZOLE MAGNESIUM (AMORPHOUS
FORM)
Page 612
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I IV 2/15/2006 KERRY INGREDIENTS AND FLAVOURS NATURAL SPEARMINT FLAVOR WONF (080-
00707) POWDER
### I II 2/21/2006 HEBEI CHANGSHAN BIOCHEMICAL HEPARIN SODIUM USP
PHARMACEUTICAL CO LTD
### A II 2/23/2006 SOLARA A PHARMA SCIENCES LTD MEFENAMIC ACID, USP
### I III 2/20/2006 BESPAK DIV CONSORT MEDICAL PLC BK357933MTA PHARMACEUTICAL METERING
VALVE
### I II 2/21/2006 EXCELLA GMBH HALOPERIDOL DECANOATE
### I II 2/22/2006 PCAS ROPINIROLE HYDROCHLORIDE
### I III 2/23/2006 FPC FLEXIBLE PACKAGING CORP PHARMACEUTICAL POUCH - FPC
SPECIFICATION 47515X
### A II 2/21/2006 MYLAN LABORATORIES LTD FORMOTEROL FUMARATE DIHYDRATE USP
### I II 2/14/2006 IND SWIFT LABORATORIES LTD ARIPIPRAZOLE
### A III 2/6/2006 ANSAPACK PVT LTD ALUMINIUM FOIL & PAPER LAMINATES
-POLYLAMINATED & HEAT SEAL LACQUER (HSC)
COATED FOR PACKING TABLETS, CAPSULES
AND OTHER SOLID DOSAGE FORMS
### I II 2/24/2006 MDS NORDION IODOFILTIC ACID I-123 STERILE INJECTION
### I V 2/16/2006 CATALENT PHARMA SOLUTIONS LLC CARDINAL HEALTH'S STERILE MANUFACTURING
FACILITIES IN SAN DIEGO, CA.
### A II 2/28/2006 INSYS MANUFACTURING LLC DRONABINOL USP
### I III 11/7/2005 HEINKE TECHNOLOGY INC A MEASURING SPOON
### I II 2/10/2006 SHANDONG WEIFANG HYDRALAZINE HYDROCHLORIDE (NON-STERILE
PHARMACEUTICAL FACTORY CO LTD A PHARMACEUTICAL INGREDIENT)
### I III 3/2/2006 LG CHEM LTD ABS PRODUCTS INTENDED FOR USE IN DRUG
PACKAGING APPLICATIONS
19211 I II 2/27/2006 SYNTHON BV ANASTROLZOLE
### I II 3/3/2006 NATCO PHARMA LTD SUMATRIPTAN
### I II 2/23/2006 ZHEJIANG CHENG YI PHARMACEUTICAL RIBAVIRIN (NON-STERILE A PHARMACEUTICAL
CO LTD INGREDIENT)
### I II 3/2/2006 NARD CHEMICALS LTD SON-216 API
### A II 3/3/2006 NATCO PHARMA LTD GRANISETRON HYDROCHLORIDE
### I II 1/19/2006 CADILA PHARMACEUTICALS LTD MELOXICAM
### A II 3/1/2006 ZHEJIANG APELOA KANGYU LOVASTATIN USP, NON-STERILE A
PHARMACEUTICAL CO LTD PHARMACEUTICAL INGREDIENT
### A II 2/28/2006 LUPIN LTD CARVEDILOL
### A IV 3/3/2006 YKF INC SYNTHETIC AMORPHOUS SILICA PRODUCTS -
SYLYSIA / ADSOLIDER
### I II 3/6/2006 TERUMO CORP IHL- 305 IRINOTECAN LIPOSOME INJECTION
### A II 2/18/2006 IND SWIFT LABORATORIES LTD CLARITHROMYCIN SPECIAL
### I II 3/3/2006 CADILA HEALTHCARE LTD ZOLPIDEM TARTRATE
### A II 3/4/2006 CADILA HEALTHCARE LTD CLINDAMYCIN HYDROCHLORIDE
### A II 2/28/2006 AUROBINDO PHARMA LTD AMPICILLIN TRIHYDRATE, USP
### A II 2/28/2006 LUPIN LTD PANTOPRAZOLE SODIUM SESQUIHYDRATE
### I II 2/25/2006 IONS PHARMA METFORMIN HYDROCHLORIDE USP
Page 613
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 3/3/2006 FLAMMA SPA LANSOPRAZOLE
### I V 3/13/2005 STERIS ISOMEDIX SERVICES STERIS INC ISOMEDIX SERVICES FACILITY IN
NOGALES, AZ.
### A II 3/7/2006 CONCORD BIOTECH LTD MYCOPHENOLATE MOFETIL USP
### I III 2/24/2006 COGNIS DEUTSCHLAND GMBH CO KG SPEZIOL G 86% PF
### I III 2/24/2006 BASF PERSONAL CARE AND NUTRITION SPEZIOL G 99,8% PF
GMBH
### A III 3/1/2006 POLYONE CORP CC10047660BG COLORANT PRODUCT
### A V 9/23/2005 TERUMO BCT LTD GAMBRO MANUFACTURING FACILITY IN ANTRIM,
NORTHERN IRELAND
### I II 3/10/2006 CADILA HEALTHCARE LTD GLYBURIDE
### A II 3/8/2006 BIOINDUSTRIA LABORATORIO ITALIANO TORSEMIDE (MOD 1) BULK SUBSTANCE
MEDICINALI SPA
### A II 2/28/2006 AUROBINDO PHARMA LTD OXACILLIN SODIUM USP
### I III 3/9/2006 COLORS FOR PLASTICS INC THERMOPLASTIC RESIN COLORANT
MASTERBATCHES E14070, E14071, AND W07769
### A III 3/10/2006 TOYO INK CO LTD 357 PTP HS D2 VARNISH C AND 790 PTP OP
VARNISH
### I III 12/19/2005 HEINKE TECHNOLOGY INC SKIN TAG (ACROCHORDON) REMOVAL DEVICE
TAGNER
### A II 3/8/2006 JOHNSON MATTHEY PHARMACEUTICAL ALENDRONIC ACID MONOHYDRATE (ALC)
MATERIALS
### A II 3/7/2006 ERREGIERRE SPA NABUMETONE USP
### A IV 1/20/2006 CHITINOR AS CHITOPHARM™ L
### A IV 1/20/2006 CHITINOR AS CHITOPHARM™ M
### A IV 1/20/2006 CHITINOR AS CHITOPHARM™ S
### A II 3/4/2006 AUROBINDO PHARMA LTD TOPIRAMATE USP
### I III 3/7/2006 MATRIX TOOL INC APPLICATOR STICK (PLASTIC INJECTION
MOLDED COMPONENT)
### I II 3/8/2006 OCEAN NUTRITION CANADA LTD 18/12 TG COMPLEX CAPSULES
### A II 3/10/2006 USV PRIVATE LTD PIOGLITAZONE HYDROCHLORIDE USP (EXTRA
PURE)
### I II 3/16/2006 SUN PHARMACEUTICAL INDUSTRIES ESCITALOPRAM OXALATE USP
LTD
### A III 3/1/2006 KEY INTERNATIONAL INC PVC/PVDC/PE LAMINATED FILM
### A II 1/3/2006 CADILA PHARMACEUTICALS LTD CHLORHEXIDINE BASE
### I II 3/8/2006 YANGTZE RIVER PHARMACY GROUP LANSOPRAZOLE, NON-STERILE DRUG
JIANGSU HAI CI BIOLOGICAL PHARMACY SUBSTANCE
CO LTD
### A III 3/15/2006 CORMACK PACKAGING PTY LTD CORMACK TECR-PP (3 PIECE TAMPER EVIDENT
CHILD RESISTANT CLOSURE FOR PILFER
PROOF NECK FINISH, 28 MM)
### A III 3/14/2006 OKADA SHIGYO CO LTD PACKAGING FILM FOR MEDICINE
### A II 3/17/2006 CSL BEHRING GMBH STERILE WATER FOR INJECTION
Page 614
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 2/6/2006 XIAN HUIFENG BIOCHEMISTRY GROUP TROXERUTIN, NON-STERILE BULK FORM
CO LTD
### I II 2/6/2006 XIAN HUIFENG BIOCHEMISTRY GROUP DIOSMIN, NON-STERILE BULK FORM
CO LTD
### A II 3/14/2006 ALCHEM INTERNATIONAL LTD 10 DEACETYL BACCATIN III (10 DAB III)
### I II 4/18/2006 IPCA LABORATORIES LTD MESALAMINE USP
### I II 3/14/2006 CHEMISCHE FABRIK BERG GMBH PENTOBARBITAL SODIUM USP
### I III 3/13/2006 COPE ALLMAN JAYCARE LTD 60ML HDPE ROUND PACKER
### A IV 3/14/2006 DAH FENG CAPSULE INDUSTRY CO LTD EMPTY HARD SHELL VEGETABLE CAPSULES
(HYDROXYPROPYL METHYL CELLULOSE)
### A II 3/15/2006 AUROBINDO PHARMA LTD PIPERACILLIN USP
### A II 3/18/2006 SUVEN LIFE SCIENCES LTD DIVALPROEX SODIUM
### A II 3/16/2006 LUPIN LTD RISPERIDONE USP
### I II 3/21/2006 TEVA PHARMACEUTICAL INDUSTRIES LORAZEPAM
LTD
### A II 3/20/2006 ENDORECHERCHE INC ACOLBIFENE, NON-STERILE A
PHARMACEUTICAL INGREDIENT
### I II 3/22/2006 AMRI RENSSELAER INC SGD-1006 (VC-MMAE) INTERMEDIATE
### A III 3/20/2006 CREATIVE TECHNOPLAST HDPE BOTTLE FOR PHARMACEUTICAL
APPLICATIONS
### A II 3/23/2006 UNIMARK REMEDIES LTD FLECAINIDE ACETATE USP
### A II 1/23/2006 GLOCHEM INDUSTRIES PRIVATE LTD CETIRIZINE DIHYDROCHLORIDE
### A IV 3/20/2006 UNGERER AND CO ARTIFICIAL BITTER MASKING FLAVOR FM-4730
### A IV 3/20/2006 UNGERER AND CO N/A BLUEBERRY FLAVOR FM-4726
### A IV 3/20/2006 UNGERER AND CO N/A STRAWBERRY FLAVOR FN-3927
### A IV 3/20/2006 UNGERER AND CO N/A GRAPE FLAVOR FM-4727
### I II 3/16/2006 SHANDONG FREDA BIOCHEM CO LTD SODIUM HYALURONATE (NON-STERILE BULK
FORM)
### A III 3/21/2006 ADIT INDUSTRIES NEUTRAL GLASS AMPOULES AND VIALS USP ( 1)
Page 617
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 4/15/2006 JEEVANLAKSHMI PACKAGING ROLL ON PILFER PROOF (ROPP) CAPS
SOLUTIONS PVT LTD
### A III 4/15/2006 JEEVANLAKSHMI PACKAGING COLLAPSIBLE ALUMINIUM TUBES
SOLUTIONS PVT LTD
### A II 4/19/2006 CHEMOSWED AB ISRADIPINE
### A III 4/20/2006 STREAM PEAK INTERNATIONAL PTE LTD PERFORMANCE DRY DESICCANT PACKETS
### A III 4/20/2006 STREAM PEAK INTERNATIONAL PTE LTD HUMI DRI DESICCANT PACKETS
### I II 10/10/2005 MATRIX LABORATORIES LTD NEVIRAPINE USP, NON-STERILE BULK FORM
### A V 4/18/2006 PAIN THERAPEUTICS INC REFERENCE INFORMATION TO SUPPORT THE
SAFETY OF CELLULOSE ACETATE BUTYRATE
381-20BP AS A PHARMACEUTICAL EXCIPIENT.
### A V 4/19/2006 PAIN THERAPEUTICS INC REFERENCE INFORMATION TO SUPPORT THE
SAFETY OF ISOPROPYL MYRISTATE AS A
PHARMACEUTICAL EXCIPIENT.
### A V 4/20/2006 PAIN THERAPEUTICS INC REFERENCE INFORMATION TO SUPPORT THE
SAFETY OF ETHYL LACTATE AS A
PHARMACEUTICAL EXCIPIENT.
### I II 4/20/2006 TONIRA PHARMA LTD FAMOTIDINE
### A II 4/20/2006 DR REDDYS LABORATORIES LTD OLMESARTAN MEDOXOMIL
### A II 3/1/2006 WOCKHARDT LTD ENTACAPONE USP
### A II 9/16/2005 CADILA PHARMACEUTICALS LTD VENLAFAXINE HYDROCHLORIDE USP
### A II 4/18/2006 AUROBINDO PHARMA LTD LEVETIRACETAM USP
### A II 4/18/2006 AUROBINDO PHARMA LTD CARISOPRODOL USP
### I IV 4/10/2006 SPI PHARMA INC PHARMAGUM(TM) C
### I II 4/18/2006 ZHEJIANG HUAYI PHARMACEUTICAL CO CLARITHROMYCIN
LTD
### I III 4/24/2006 PETROMONT INC HIGH DENSITY POLYETHYLENE RESINS HDPE
1000 AND HDPE 1002
### I III 4/20/2006 TEKNOR COLOR CO COLOR CONCENTRATE 91,355HCTPE WHITE
50:1
### A III 4/25/2006 EMS CHEMIE NORTH AMERICA INC GRIVORY HB 7103 NATURAL
### I III 4/7/2006 RESPONSIVE POLYMERS LTD PVC FILMS
### A III 5/1/2006 INEOS CHLORVINYLS BELGIUM NV NORVINYL S7102
### I II 5/1/2006 SIEGFRIED USA INC OXYCODONE HYDROCHLORIDE USP
### A II 4/29/2006 SUVEN LIFE SCIENCES LTD (R)-(-)-5-(2-AMINOPROPYL)-2-
METHOXYBENZENE SULPHONAMIDE
HYDROCHLORIDE DRUG INTERMEDIATE
### A II 4/26/2006 AUROBINDO PHARMA LTD ZALEPLON USP
### I II 5/1/2006 SANDOZ INDUSTRIAL PRODUCTS SPA LOVASTATIN DRUG SUBSTANCE INTERMEDIATE
### A II 5/2/2006 GLENMARK PHARMACEUTICALS LTD LORATADINE USP
### A II 5/2/2006 ORCHID PHARMA LTD CEFDINIR FORM-B
### A II 4/20/2006 SYMBIOTEC PHARMALAB PRIVATE LTD HALOBETASOL PROPIONATE
Page 618
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 5/2/2006 TEVA PHARMACEUTICAL INDUSTRIES DESLORATADINE DRUG SUBSTANCE
LTD
### I II 5/1/2006 BIOCON LTD ROSIGLITAZONE MALEATE DRUG SUBSTANCE
### I IV 4/25/2006 HENRY H OTTENS MANUFACTURING CO NATURAL MINT FLAVOR #9295
INC
### I IV 4/25/2006 HENRY H OTTENS MANUFACTURING CO NATURAL PEPPERMINT FLAVOR EXTRACT #7801
INC
### A II 6/13/2006 ZHEJIANG EXCEL PHARMACEUTICAL CO GEIBROZIL USP
LTD
### I II 5/5/2006 ISOCHEM SAS CARISOPRODOL
### A II 4/29/2006 AUROBINDO PHARMA LTD CLOPIDOGREL BISULFATE USP
### I II 4/21/2006 COSMA SPA BICALUTAMIDE
19411 I II 4/26/2006 ERCROS INDUSTRIAL SA FYSE COMPACTIN
### I III 5/3/2006 M AND H PLASTICS PACKAGING MATERIAL
### A II 5/8/2006 AARTI INDUSTRIES LTD QUINAPRIL HYDROCHLORIDE USP
### I III 5/5/2006 3M DRUG DELIVERY SYSTEMS DIV SCOTCHPAK 9734, 2-MIL POLYESTER FILM
LAMINATE
### A II 5/9/2006 FORMOSA LABORATORIES INC CALCIPOTRIOL ANHYDROUS
### A II 5/9/2006 MALLADI DRUGS AND THREO-RITALINIC ACID AND SALT
PHARMACEUTICALS LTD
### A II 5/9/2006 URQUIMA SA OLOPATADINE HYDROCHLORIDE
### A V 5/5/2006 DAIKYO SEIKO LTD RSV COMPONENT WASHING PROCESS AT SANO
HANEDA PLANT I
### A II 4/28/2006 SOUTHWEST SYNTHETIC MECLIZINE HYDROCHLORIDE
PHARMACEUTICAL CORP LTD
### I II 5/8/2006 HANZHONG HANJIANG VENTUREPHARM BUPROPION HYDROCHLORIDE
PHARMACEUTICAL LTD
### I II 5/8/2006 BEIJING YI HE BIOTECH CO LTD PACLITAXEL USP, NON-STERILE BULK
### A II 5/5/2006 EUTICALS SPA AZELASTINE HYDROCHLORIDE
### I II 5/8/2006 PCAS INDOCYANINE GREEN
### I IV 4/27/2006 EVONIK DEGUSSA CORP CALCIUM SILICATE
### A II 4/20/2006 SHANDONG LUNAN BETTER MOSAPRIDE CITRATE (NON-STERILE BULK
PHARMACEUTICAL CO LTD FORM)
### A II 5/12/2006 HELSINN ADVANCED SYNTHESIS SA SODIUM BENZOATE
### A II 5/16/2006 SUN PHARMACEUTICAL INDUSTRIES GEMCITABINE HYDROCHLORIDE USP
LTD
### A II 5/12/2006 GLENMARK PHARMACEUTICALS LTD DESLORATADINE
### A II 5/15/2006 GEDEON RICHTER PLC NORGESTIMATE USP
### A IV 5/5/2006 RELIANCE CELLULOSE PRODUCTS LTD CARBOXYMETHYLCELLULOSE SODIUM USP
### A III 5/15/2006 WACKER CHEMICAL CORP VINNOL(R) E 22/48 A
### I II 5/15/2006 SINTENOVO SA DE CV CETIRIZINE DIHYDROCHLORIDE
### A II 5/10/2006 ZHEJIANG XIANJU PHARMACEUTICAL MEDROXYPROGESTERONE ACETATE USP, NON-
CO LTD STERILE BULK DRUG SUBSTANCE
### A II 5/16/2006 SOFIE CO DBA SOFIE IODINE-124
Page 619
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 5/4/2006 FLEXTRUS AB TRANSOFOIL EL-OPET/PELD LAMINATE,
SPECIFICATION 2383150-0008
### I III 5/4/2006 FLEXTRUS AB TRANSOFOIL EL-OPET/PELD, SPECIFICATION
2383150-0008
### I III 5/4/2006 FLEXTRUS AB TRANSOFOIL EL-OPET/PE LAMINATE, MATERIAL
SPECIFICATION M80142
### I II 5/12/2006 ISOTEC POTASSIUM PALMITATE-1,2,3,4-(13)C(4) FOR
CLINICAL RESEARCH
### A IV 5/16/2006 CATALENT ONTARIO LTD GELATIN MASS FOR SOFT GEL CAPSULES
### A II 5/16/2006 AARTI DRUGS LTD ZOLPIDEM TARTRATE
### I II 5/17/2006 DIVIS LABORATORIES LTD DESLORATADINE
### I II 3/10/2006 HEC PHARM CO METRONIDAZOLE USP, NON-STERILE BULK
FORM
### A II 3/20/2006 HEC PHARM CO LTD ERYTHROMYCIN THIOCYANATE,
PHARMACEUTICAL INTERMEDIATE BULK FORM
### A II 3/20/2006 HEC PHARM CO LTD ERYTHROMYCIN USP, NON-STERILE BULK
FORM
### A III 5/9/2006 ROY + LECLAIR EMBALLAGE INC ROPACKS (ROUND PACKER BOTTLES)
### A II 5/12/2006 JUBILANT GENERICS LTD ESCITALOPRAM OXALATE USP
### A II 5/1/2006 PIRAMAL ENTERPRISES LTD OXYBUTYNIN CHLORIDE
### A II 5/18/2006 PAR A TECHNOLOGIES PRIVATE LTD MOLINDONE HYDROCHLORIDE
### A II 5/16/2006 ZHEJIANG SUPOR PHARMACEUTICALS FELODIPINE, NON-STERILE DRUG SUBSTANCE
CO LTD USP
### A II 5/16/2006 ZHEJIANG SUPOR PHARMACEUTICALS SECNIDAZOLE
CO LTD
### I II 5/22/2006 MITSUBISHI TANABE PHARMA CORP Y-39983 DRUG SUBSTANCE
### A II 5/17/2006 CHEMCO PLUS SCIENTIFIC CO LTD LC-SORB SPW-C-ODS(S)
### A IV 5/22/2006 COREL PHARMACHEM ACRYCOAT, METHACRYLIC ACID COPOLYMER
### A II 5/22/2006 AUROBINDO PHARMA LTD GEIBROZIL USP
### A II 5/25/2006 SUN PHARMACEUTICAL INDUSTRIES FOSPHENYTOIN SODIUM USP
LTD
### A II 5/24/2006 DR REDDYS LABORATORIES LTD DESLORATADINE
### A II 5/23/2006 SOCIETA ITALIANA MEDICINALI KETOPROFEN
SCANDICCI SIMS SRL
### A II 5/19/2006 APOTEX PHARMACHEM INDIA PVT LTD LEVOFLOXACIN USP
### I III 5/19/2006 3M DRUG DELIVERY SYSTEMS 3M COTRAN 9691 POLYESTER TAPE
### A II 5/26/2006 SIEGFRIED USA LLC HYDROCODONE BITARTRATE USP
### I II 5/23/2006 3M DRUG DELIVERY SYSTEMS DIV DROSPIRENONE/ETHINYL ESTRADIOL
TRANSDERMAL DELIVERY SYSTEM
### A III 5/23/2006 BESPAK DIV CONSORT MEDICAL PLC BK920 SERIES PHARMACEUTICAL ORAL
ACTUATORS AND DUST CAPS
### A II 5/24/2006 MEDICHEM MANUFACTURING MALTA ZALEPLON (MED - 201970)
LTD
### I II 5/22/2006 ST GOBAIN PERFORMANCE PLASTICS SANIPURE(TM) 60 BIOPHARMACEUTICAL
CORP TUBING
Page 620
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 5/22/2006 INDUSTRIALE CHIMICA SRL MEMANTINE HYDROCHLORIDE USP
### A II 5/26/2006 JOHNSON MATTHEY INC OXANDROLONE
PHARMACEUTICAL MATERIALS
### A II 5/19/2006 PEPTIDO GMBH LIOTHYRONINE SODIUM
### A II 5/24/2006 RHODIA OPERATIONS GADOLINIUM OXIDE
### I II 4/15/2006 DOSHION LTD P-544S - POTASSIUM SALT OF POLACRYLIC ACID
WITH PERCENTAGE OF POTASSIUM TO EXTENT
OF 17-20%
### I II 4/15/2006 DOSHION LTD P-544D - POTASSIUM SALT OF POLACRYLIC ACID
WITH PERCENTAGE OF POTASSIUM TO EXTENT
OF 24.5-25.5%
### I II 4/15/2006 DOSHION LTD P-542, SODIUM SALT OF POLACRYLIC ACID
### A II 5/24/2006 APICORE US LLC FOMEPIZOLE
### A II 5/26/2006 NOF CORP PL-2000CS PHOSPHOLIPID COMPOUND
### A II 5/26/2006 DSM NUTRITIONAL PRODUCTS LTD BONISTEIN(TM) - GENISTEIN CRYSTALLINE
### I II 5/17/2006 ST GOBAIN PERFORMANCE PLASTICS TYGON (R)R 3350 - SANITARY SILICONE TUBING
CORP
### A II 5/26/2006 FARMAK AS ALFUZOSIN HYDROCHLORIDE
### A II 5/31/2006 FARMABIOS SPA FLUNISOLIDE ANHYDROUS USP
### A II 5/26/2006 AUROBINDO PHARMA LTD CEFEPIME HYDROCHLORIDE, NON-STERILE
INTERMEDIATE DRUG SUBSTANCE
### A II 5/31/2006 UNIMARK REMEDIES LTD BENAZEPRIL HYDROCHLORIDE USP
### I II 5/25/2006 ARCHIMICA SRL TERAZOSIN HYDROCHLORIDE
### A II 5/31/2006 BASF SE DERMAZ 99 (AZELAIC ACID)
### A II 5/30/2006 PCAS CICLETANINE
### I III 5/30/2006 3M DRUG DELIVERY SYSTEMS DIV KOLLICOAT SMARTSEAL 30 D PRE-CLINICAL
SAFETY DATA
### A II 5/31/2006 AUROBINDO PHARMA LTD PERINDOPRIL TERT-BUTYLAMINE DRUG
SUBSTANCE
### A II 5/31/2006 NUVIEW LIFE SCIENCES INC COPPER CHLORIDE (CU-64) RADIOCHEMICAL
### A III 6/2/2006 BPREX HEALTHCARE OFFRANVILLE SAS SOF' BAG SETS
Page 622
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 6/19/2006 HOFFMANN LA ROCHE INC INTERLEUKIN-2 (HUMAN, RECOMBINANT, E.
COLI, HOFFMAN-LA ROCHE)
### A IV 6/13/2006 UNGERER AND CO N/A CHERRY FLVP FLAVOR WS FO-1979
### A II 4/30/2006 CAMBREX KARLSKOGA AB LIDOCAINE HYDROCHLORIDE
### A II 4/30/2006 CAMBREX KARLSKOGA AB LIDOCAINE
### A II 6/15/2006 ZHEJIANG HUAHAI PHARMACEUTICAL CARVEDILOL USP
CO LTD
### A II 6/19/2006 ISOCHEM SAS AMBOX
### A II 6/20/2006 FINETECH PHARMACEUTICAL LTD LATANOPROST DRUG SUBSTANCE
### I II 6/19/2006 KREBS BIOCHEMICALS INDUSTRIES LTD SIMVASTATIN AMMONIUM SALT (INTERMEDIATE)
### A IV 7/20/2006 ACG ASSOCIATED CAPSULES PVT LTD EXCIPIENT CELLULOSE CAPSULE SHELLS
### I II 7/22/2006 WANBURY LTD GLUCOSAMINE SULFATE SODIUM CHLORIDE
### A II 7/31/2006 NOF CORP DSPC (DISTEAROYL PHOSPHATIDYLCHOLINE)
### A II 7/26/2006 AUROBINDO PHARMA LTD CEFACLOR USP
### A II 7/28/2006 AUROBINDO PHARMA LTD CEFTAZIDIME DIHYDROCHLORIDE, NON-
STERILE DRUG SUBSTANCE INTERMEDIATE
### A II 8/3/2006 ORCHID PHARMA LTD MODAFINIL
### A II 7/31/2006 POLYPEPTIDE LABORATORIES SWEDEN EXENATIDE DRUG SUBSTANCE
AB
### A II 8/2/2006 SUVEN LIFE SCIENCES LTD TAMSULOSIN HYDROCHLORIDE
### A II 8/4/2006 SUN PHARMACEUTICAL INDUSTRIES OXALIPLATIN USP
LTD
### A II 7/31/2006 AUROBINDO PHARMA LTD TOLTERODINE TARTRATE, NON-STERILE DRUG
SUBSTANCE
### A III 8/2/2006 LABLABO SELECT AIRLESS PUMP AND BOTTLE .
### I III 6/15/2006 RITE SYSTEMS INC WHITE, NQC-W1317-7, LIQUID COLOR
CONCENTRATE
### A II 8/3/2006 ERREGIERRE SPA CELECOXIB USP-EP
### A IV 7/4/2006 DOOSAN BIOTECH BUSINESS DIV DS-PL95E PURIFIED EGG YOLK LECITHIN FOR
UTILIZATION IN FAT EMULSION PRODUCTION
### A V 7/28/2006 CELSIS INC CELSIS RAPISCREEN HEALTH
### A II 8/3/2006 ANTIBIOTICOS DO BRASIL LTDA ARGININE USP, STERILE BULK
### I II 8/4/2006 ABBOTT LABORATORIES HYDROCODONE/ACETAMINOPHEN EXTENDED
RELEASE TABLETS
Page 626
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 7/5/2006 ZHEJIANG APELOA JIAYUAN METHOCARBAMOL API
PHARMACEUTICAL CO LTD
### I II 8/4/2006 OPOCRIN SPA DALTEPARIN SODIUM BULK
### A III 8/1/2006 BASELL POLIOLEFINE ITALIA SRL PURELL PE 3220 D
### I II 7/27/2006 SAI PHYTOCEUTICALS PVT LTD PACLITAXEL
### I II 7/27/2006 SAI PHYTOCEUTICALS PVT LTD IRINOTECAN HYDROCHLORIDE TRIHYDRATE
### A II 8/7/2006 NEULAND LABORATORIES LTD ESCITALOPRAM OXALATE
### A II 6/20/2006 ARCH PHARMALABS LTD ESCITALOPRAM OXALATE
### A IV 7/31/2006 UNGERER AND CO N/A COUGH SYRUP MASKER FLAVOR FN-6819
### A IV 7/31/2006 UNGERER AND CO N/A CHERRY BERRY FL FM-4725
### A IV 7/31/2006 UNGERER AND CO ART. STRAWBERRY FLAVOR FO-1022
### A IV 7/31/2006 UNGERER AND CO N/A STRAWBERRY FL WS FN-8378
### I II 8/6/2006 ZHEJIANG CHENG YI PHARMACEUTICAL MERCAPTOPURINE, USP, NON-STERILE A
CO LTD PHARMACEUTICAL INGREDIENT
### I II 8/6/2006 ZHEJIANG CHENG YI PHARMACEUTICAL AZATHIOPRINE USP, NON-STERILE A
CO LTD PHARMACEUTICAL INGREDIENT
### I II 8/9/2006 DAIICHI SANKYO CO LTD SUN13834 DRUG SUBSTANCE
### A II 8/5/2006 AUROBINDO PHARMA LTD LOSARTAN POTASSIUM USP DRUG SUBSTANCE
Page 627
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 8/31/2007 EASTMAN CHEMICAL CO BIOSUSTANE® SAIB (SUCROSE ACETATE
ISOBUTYRATE)
### A II 7/26/2006 BIA SEPARATIONS DOO CIM CONVECTIVE INTERACTION MEDIA® QA
### I II 8/18/2006 SANDOZ GMBH STERILE NAFCILLIN SODIUM, BUFFERED
### A II 8/18/2006 LUPIN LTD BENAZEPRIL HYDROCHLORIDE USP (PROCESS
B)
### I II 8/21/2006 3M DRUG DELIVERY SYSTEMS DIV MINITRAN (NITROGLYCERIN) TRANSDERMAL
DELIVERY SYSTEM - CHEMISTRY
### A IV 8/16/2006 UNGERER AND CO N/A PINEAPPLE FLAVOR FM-4130
### A III 8/22/2006 ACTEGA RHENANIA GMBH 28505-18014 (LOR 30) COATING LACQUER
### A II 8/22/2006 TEVA PHARMACEUTICAL INDUSTRIES ZOLEDRONIC ACID
LTD
### I II 8/14/2006 WOCKHARDT LTD CYANOCOBALAMIN USP
### I II 4/2/2007 MERRION PHARMACEUTICALS MER-104A GIPET 10MG ENTERIC TABLETS
### A IV 8/18/2006 HONEYWELL INTERNATIONAL INC HONEYWELL PHARMACEUTICAL HFA-134A
### I II 8/25/2006 MARTEK BIOSCIENCES CORP DOCOSAHEXAENOIC ACID A SINGLE CELL OIL
(DHASCO) 55%, DHASCO CAPSULES, 510 MG
DHA, AND PLACEBO TO MATCH DHASCO
CAPSULES
### A IV 8/18/2006 STERLING BIOTECH LTD GELATIN B
### I III 8/22/2006 PRETIUM PACKAGING PLASTIC RESINS, PLASTIC COLORANTS AND
PLASTIC ADDITIVES
### A II 8/21/2006 WOCKHARDT LTD GRANISETRON HYDROCHLORIDE
### I II 8/28/2006 SAI LIFE SCIENCES LTD MILRINONE
### A II 8/28/2006 HARMAN FINOCHEM LTD GLYCOPYRROLATE USP
19711 A II 8/17/2006 AUROBINDO PHARMA LTD FOSINOPRIL SODIUM USP
### A II 8/11/2006 ZHEJIANG HUAHAI PHARMACEUTICAL NEVIRAPINE USP
CO LTD
### A II 8/28/2006 DR REDDYS LABORATORIES LTD OMEPRAZOLE (FORM B) USP
### A II 8/28/2006 AARTI INDUSTRIES LTD RAMIPRIL USP (GRADE A)
### A II 9/8/2006 INDUSTRIALE CHIMICA SRL EPLERENONE
### I II 8/29/2006 SHANGHAI ZHONGXI SUNVE CLOTRIMAZOLE
PHARMACEUTICAL CO LTD
### A II 8/30/2006 GLENMARK PHARMACEUTICALS LTD EZETIMIBE (PROCESS I)
### I III 8/28/2006 APTAR FRANCE SAS EQUADEL METERED DOSE PUMPS
### I II 8/30/2006 AARTI INDUSTRIES LTD RAMIPRIL USP, GRADE II
### I II 8/26/2006 WOCKHARDT LTD TRANDOLAPRIL
### A II 8/31/2006 POSH CHEMICALS PRIVATE LTD HYDROCHLOROTHIAZIDE USP
### A II 8/31/2006 MALLADI DRUGS AND 2-(4' METHOXYPHENYL) -2-(1-
PHARMACEUTICALS LTD HYDROXYCYCLOHEXYL) ETHYLAMINE ACETATE
(MHE ACETATE)
### A II 8/31/2006 HUBEI BIOCAUSE HEILEN FLUMAZENIL
PHARMACEUTICAL CO LTD
### I II 7/28/2006 CAMBREX CHARLES CITY INC FENTANYL CITRATE USP MICRONIZED
### A II 9/1/2006 CIPLA LTD LANSOPRAZOLE USP
Page 628
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 8/31/2006 HUBEI BIOCAUSE HEILEN MILRINONE
PHARMACEUTICAL CO LTD
### I III 8/25/2006 CEODEUX MEDITEC SA HIGH PRESSURE VALVE RANGE D 335 FOR
CYLINDERS CONTAINING GASEOUS MIXTURE
DRUGS UNDER PRESSURE
### I II 7/27/2006 BENGBU BAYI PHARMACEUTICAL CO PARACETAMOL (OR ALTERNATIVELY KNOWN AS
LTD ACETAMINOPHEN)
### I II 9/4/2006 DIVIS LABORATORIES LTD SIBUTRAMINE HYDROCHLORIDE
MONOHYDRATE
### A II 8/31/2006 AUROBINDO PHARMA LTD TAMSULOSIN HCI USP
### A IV 8/31/2006 NOF CORP N-(METHYLPOLYOXYETHYLENE
OXYCARBONYL)-1, 2- DISTEAROYL--SN-
GLYCERO-3- PHOSPHOETHANOLAMINE SODIUM
SALT (DSPE-PEG2000)
### I II 8/31/2006 ST GOBAIN PERFORMANCE PLASTICS SANIPURE(TM) BDF(TM) BIOPHARMACEUTICAL
CORP TUBING
### I II 8/31/2006 ST GOBAIN PERFORMANCE PLASTICS TYGON(R) LFL BIOPHARMACEUTICAL TUBING
CORP
### A II 9/6/2006 TIANJIN JINJIN PHARMACEUTICAL CO HYDROCORTISONE BASE
LTD
### A II 9/6/2006 GLENMARK PHARMACEUTICALS LTD IMIQUIMOD USP
### A II 11/7/2006 ALCAMI WISCONSIN CORP FP-062
### A II 9/6/2006 BEIJING TAIYANG PHARMACEUTICAL DIPHENHYDRAMINE HYDROCHLORIDE
INDUSTRY CO LTD
### I II 8/31/2006 CAMBREX CHARLES CITY INC LEVETIRACETAM
### A II 8/31/2006 JUBILANT GENERICS LTD ARIPIPRAZOLE USP
### I II 5/15/2006 ZHEJIANG WEPON PHARMACEUTICAL LORATADINE
CO LTD
### I II 5/15/2006 ZHEJIANG WEPON PHARMACEUTICAL CLINDAMYCIN PHOSPHATE
CO LTD
### A III 9/1/2006 KUNSTSTOFFWERK KREMSMUNSTER PP 28 CAPS T/E
GMBH
### I II 9/8/2006 ZAKLADY FARMACEUTYCZNE METOPROLOL SUCCINATE
POLPHARMA SA
### A II 9/5/2006 VITALIFE LABORATORIES DIV ARCH CLOPIDOGREL BISULFATE USP
PHARMALABS LTD
### A II 9/11/2006 HETERO LABS LTD THALIDOMIDE USP
### A II 9/11/2006 GLENMARK PHARMACEUTICALS LTD LINEZOLID
### A II 9/11/2006 ORCHID PHARMA LTD LEVETIRACETAM
### A II 2/7/2008 CIPLA LTD ANASTROZOLE USP
### A II 8/24/2006 CIPLA LTD ZOLEDRONIC ACID
### A II 8/24/2006 CIPLA LTD BECLOMETHASONE DIPROPIONATE
### A II 9/11/2006 ORCHID PHARMA LTD PAROXETINE HYDROCHLORIDE
### A II 9/8/2006 SUVEN LIFE SCIENCES LTD NITAZOXANIDE
### A II 4/3/2008 CIPLA LTD NEVIRAPINE HEMIHYDRATE USP
Page 629
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A V 8/15/2006 SANDOZ GMBH STERILIZATION PROCESS VALIDATION
INFORMATION FOR THE STERILE PENICILLIN
PLANT
### I II 9/7/2006 AUROBINDO PHARMA LTD CEFEPIME FOR INJECTION USP (STERILE BULK)
### A III 9/11/2006 SHIN ETSU KASEI KOGYO CO LTD ADSORBENT SE-PACK
### I III 8/30/2006 DURAN PRODUKTIONS GMBH AND CO DURAN PREMIUM LABORATORY BOTTLE WITH
KG SCREW CAP
### A II 9/6/2006 ROTEM INDUSTRIES LTD OXYGEN 18 ENRICHED WATER
### I II 9/11/2006 DR REDDYS LABORATORIES LTD TELMISARTAN
### A II 9/13/2006 CADILA HEALTHCARE LTD METOPROLOL SUCCINATE USP
### A III 9/11/2006 ARCH PLASTICS PACKAGING PACKAGING MATERIALS
### I II 9/13/2006 QILU PHARMACEUTICAL CO LTD ONDANSETRON
### A II 8/24/2006 NAKODA CHEMICALS LTD ACETAZOLAMIDE
### I II 9/14/2006 EURAND INC EUR-1042 ORALLY DISINTEGRATING TABLETS
### A II 9/12/2006 PMC ISOCHEM TRIMEBUTINE MALEATE
### A II 8/28/2006 EVONIK REXIM NANNING L-ASPARTIC ACID
PHARMACEUTICAL CO LTD
### A IV 9/11/2006 NICHIRIN CHEMICAL INDUSTRIES LTD CARMELLOSE JP
### I II 9/2/2006 ISOCHEM FENOLDOPAM MESYLATE USP
### A II 8/28/2006 EVONIK REXIM NANNING L-ALANINE
PHARMACEUTICAL CO LTD
### I II 9/1/2006 SAFC BIOSCIENCES INC EX-CELL 302 CHO SERUM-FREE MEDIUM W/O L-
GLUTAMINE
### I II 9/1/2006 SAFC BIOSCIENCES INC EX-CELL 325 PF CHO (MODIFIED) SERUM-FREE
PROTEIN-FREE W/L-GLUTAMINE
### I II 9/1/2006 SAFC BIOSCIENCES INC EX-CELL 325 PF CHO (MODIFIED) SERUM-FREE
PROTEIN-FREE W/L-GLUTAMINE W/O SODIUM
BICARBONATE
### A II 9/15/2006 NAVINTA LLC NICARDIPINE HYDROCHLORIDE
### I II 9/14/2006 BOEHRINGER INGELHEIM PHARMA SCOPOLAMINE (HYOSCINE)
GMBH AND CO KG
### A II 9/13/2006 AARTI DRUGS LTD TERBINAFINE HYDROCHLORIDE
### I II 9/18/2006 PHOSPHAGENICS LTD TOCOPHERYL PHOSPHATE MIX (TPM)
### A II 9/18/2006 ABBEY COLOR INC FLUORESCEIN USP
### A III 9/19/2006 KYORAKU CO LTD POLYETHYLENE BAG FOR MEDICAL SUPPLIES
(MIRASON 53)
### I II 4/3/2007 SHISEIDO CO LTD SODIUM HYALURONATE OF PHARMACEUTICAL
GRADE CONSISTING OF INTERMEDIATE (SZE
AND API (LM)
### A II 9/11/2006 ALEMBIC PHARMACEUTICALS LTD ROPINIROLE HYDROCHLORIDE USP
### I II 9/20/2006 SYMBIOTEC PHARMALAB PRIVATE LTD MOMETASONE FUROATE
### I II 9/19/2006 DR REDDYS LABORATORIES LTD BICALUTAMIDE
### A II 9/20/2006 JOHNSON MATTHEY PHARMACEUTICAL TETRAHYDROCANNABINOL (THC) IN SESAME
MATERIALS OIL
Page 630
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 11/13/2008 CIPLA LTD DIDANOSINE USP
### A II 9/22/2006 CIPLA LTD EMTRICITABINE
### I II 12/1/2006 STANDARD CHEM AND PHARM CO LTD ALFUZOSIN HYDROCHLORIDE
### I II 9/19/2006 ST GOBAIN PERFORMANCE PLASTICS TYGON 2775 HIGH PURITY TUBING AND TYGON
CORP 2275 IB HIGH PURITY PRESSURE TUBING
### A II 9/19/2006 ST GOBAIN PERFORMANCE PLASTICS PHARMAPURE LOW SPALLATION PUMP TUBING
CORP
### I II 9/19/2006 ANTIBIOTICOS DO BRASIL LTDA CEFOXITIN SODIUM STERILE BULK
### A II 9/14/2006 JUBILANT GENERICS LTD IRBESARTAN USP
### I II 9/21/2006 NUVIEW LIFE SCIENCES INC COPPER CHLORIDE CU-67 RADIOCHEMICAL
### A II 9/18/2006 ZHEJIANG SHENZHOU PROGESTERONE USP (BULK)
PHARMACEUTICAL CO LTD
### A III 9/21/2006 BORMIOLI PHARMA SPA HDPE BOTTLE 60 ML - FI9190
### A II 10/3/2006 CADILA HEALTHCARE LTD LANSOPRAZOLE USP
### A III 9/25/2006 PPC INDUSTRIES INC FORM-FILL-SEAL WEB MATERIAL
### I II 9/25/2006 APOTEX PHARMACHEM INC EPLERENONE MEK HEMISOLVATE (1:0.5)
### A II 9/26/2006 ACS DOBFAR SPA CRUDE CEFEPIME HYDROCHLORIDE
### A II 9/22/2006 SUN PHARMACEUTICAL INDUSTRIES VENLAFAXINE HYDROCHLORIDE USP
LTD
### A II 9/26/2006 MYLAN LABORATORIES LTD RITONAVIR USP (FORM-II)
### I II 9/26/2006 FLEMING LABORATORIES LTD CARISOPRODOL USP
### I IV 9/27/2006 EVONIK DEGUSSA CORP SODIUM ALUMINUM SILICATE
### I II 9/22/2006 TAIZHOU HIGHSUN PHARMACEUTICAL PAROXETINE HYDROCHLORIDE HEMIHYDRATE
CO LTD USP
### A II 9/28/2006 GRANULES INDIA LTD ACETAMINOPHEN USP
### A II 9/25/2006 AUROBINDO PHARMA LTD SULBACTAM SODIUM USP (STERILE) BULK
### A II 9/26/2006 ANTIBIOTICOS DO BRASIL LTDA CEFEPIME FOR INJECTION USP (STERILE BULK)
Page 631
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 10/2/2006 NIPPON FINE CHEMICAL CO LTD A LIPOSOMAL EXCIPIENT
DIPALMITOYLPHOSPHATIDYLCHOLINE (DPPC)
### A IV 10/2/2006 NIPPON FINE CHEMICAL CO LTD A LIPOSOMAL EXCIPIENT 1-PALMITOYL-2-
OLEOYL-PHOSPHATIDYLGLYCEROL (POPG)
### A II 10/2/2006 WUHAN SHIJI PHARMACEUTICAL CO LTD CLOZAPINE
### I III 9/21/2006 CONSOLIDATED BOTTLE CORP 4 LITRE WIDEMOUTH ROUND JAR 110MM
### I III 6/6/2006 T AND S BLOWMOULDING INC COBALT 60 GAMMA IRRADIATION CONTRACT
STERILIZATION FACILITY LOCATED IN READING,
BERKSHIRE, ENGLAND
### I III 6/6/2006 T AND S BLOWMOULDING INC COBALT 60 GAMMA IRRADIATION CONTRACT
STERILIZATION FACILITY LOCATED IN
BRADFORD, WEST YORKSHIRE, ENGLAND
### A III 9/28/2006 APTAR FRANCE SAS LANDMARK DOSE INDICATING ACTUATOR
### A II 10/4/2006 TEVA PHARMACEUTICAL INDUSTRIES MONTELUKAST SODIUM
LTD
### I III 9/27/2006 AMPACET CORP AMPACET 162805-MX MB AZUL
### I III 9/27/2006 AMPACET CORP AMPACET 169181-MX MB AZUL
### I III 9/27/2006 AMPACET CORP AMPACET 171921-MX MB VERDE
### I III 9/27/2006 AMPACET CORP AMPACET 171920-MX MB AZUL
### I II 10/4/2006 DR REDDYS LABORATORIES LTD TOPOTECAN HYDROCHLORIDE
### A II 9/27/2006 JUBILANT GENERICS LTD BUPROPION HYDROCHLORIDE USP
### I II 9/26/2006 JUBILANT ORGANOSYS LTD QUETIAPINE FUMARATE
### A II 9/29/2006 AUROBINDO PHARMA LTD STAVUDINE USP (NON-STERILE DRUG
SUBSTANCE)
### I III 9/27/2006 ROHM AND HAAS CO AQUABOND 444A AND AQUABOND 444D
### I II 10/5/2006 MYLAN LABORATORIES LTD RITONAVIR USP (FORM I)
### A II 10/9/2006 CADILA HEALTHCARE LTD PROMETHAZINE HYDROCHLORIDE
### A II 10/9/2006 CADILA HEALTHCARE LTD ARIPIPRAZOLE
### I II 10/5/2006 BASF SE DRY VITAMIN D3 50
### I II 10/5/2006 ST GOBAIN PERFORMANCE PLASTICS PHARMED BPT BIOCOMPATIBLE TUBING
CORP
### I II 10/5/2006 ST GOBAIN PERFORMANCE PLASTICS TYGON S-50-HL MEDICAL/SURGICAL TUBING
CORP
### I III 10/6/2006 WEATHERCHEM CORP DISPENSING CLOSURE
### A II 10/6/2006 JOHNSON MATTHEY PHARMACEUTICAL HYDROMORPHONE HCI, USP
MATERIALS
### I II 10/6/2006 3M DRUG DELIVERY SYSTEMS DIV MAXAIR AUTOHALER (PIRBUTEROL ACETATE
INHALATION AEROSOL)
### A II 10/3/2006 JOHNSON MATTHEY PHARMACEUTICAL HYDROCODONE BITARTRATE USP
MATERIALS
Page 632
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 10/6/2006 ROLLPRINT PACKAGING PRODUCTS INC RPP# 36-1223
### I II 10/6/2006 AUROBINDO PHARMA LTD INDINAVIR SULFATE USP (NON-STERILE DRUG
SUBSTANCE)
### A II 10/10/2006 HETERO LABS LTD LOPINAVIR USP
### A II 10/10/2006 HETERO DRUGS LTD PRAMIPEXOLE DIHYDROCHLORIDE
### A III 6/9/2006 ROY + LECLAIR EMBALLAGE INC FLAT OVAL FAMILY OF BOTTLES
### A III 6/9/2006 ROY + LECLAIR EMBALLAGE INC CYLINDER FAMILY OF BOTTLES
### A II 12/6/2006 EMCURE PHARMACEUTICALS LTD ATAZANAVIR SULFATE
### I II 11/7/2006 IPCA LABORATORIES LTD BENDROFLUMETHIAZIDE USP
### A II 11/1/2006 AURISCO PHARMACEUTICAL CO LTD FLUMETHASONE
### I II 10/12/2006 ZHEJIANG XINHUA PHARMACEUTICAL SPIRONOLACTONE
CO LTD
### I II 10/12/2006 MATRIX LABORATORIES LTD DULOXETINE HYDROCHLORIDE
### A II 10/12/2006 MYLAN LABORATORIES LTD ATOMOXETINE HYDROCHLORIDE USP
### A II 10/9/2006 AUROBINDO PHARMA LTD LOPINAVIR (NON STERILE DRUG SUBSTANCE)
### A II 10/3/2006 ERREDUE SPA INNOVATIVE CHEMICAL STAVUDINE
AND LIFE
### A IV 10/13/2006 SIEGFRIED USA LLC CELLULOSE ACETATE BUTYRATE NF
### I II 10/13/2006 RANBAXY LABORATORIES LTD 7-AMINO-3-VINYL-3-CEPHEM-4-CARBOXYLIC
ACID [7-AVCA] DRUG SUBSTANCE
INTERMEDIATE
### I II 10/13/2006 RANBAXY LABORATORIES LTD CEFDINIR
### I IV 10/9/2006 CARGILL FLAVOR SYSTEMS US LLC NATURAL MIXED BERRY FLAVOR WONF (125-
01054) - LIQUID
### A III 10/18/2006 ALUFLEXPACK NOVI DOO BLISTER FOIL
### I IV 10/17/2006 PRENIUM INGRDIENTS GROUP ARTIFICIAL MIXED BERRY FLAVOR (118A09F)
### A II 10/16/2006 TEVA PHARMACEUTICAL INDUSTRIES DIFLUPREDNATE
LTD
### A II 10/16/2006 DR REDDYS LABORATORIES LTD DIVALPROEX SODIUM USP
### A III 10/9/2006 WACKER CHEMIE AG ELASTOSIL R PLUS 400/40
### I III 10/13/2006 3M DRUG DELIVERY SYSTEMS 3M COTRAN 9699 POLYURETHANE-POLYOLEFIN
TAPE
### A III 10/16/2006 3M DRUG DELIVERY SYSTEMS 3M COTRAN 9700
### I III 10/16/2006 3M DRUG DELIVERY SYSTEMS DIV 3M COTRAN 9767 EVA-BLEND TAPE
### I II 10/16/2006 ZHEJIANG XINHUA PHARMACEUTICAL CIPROFLOXACIN HYDROCHLORIDE
CO LTD
### I II 10/17/2006 RAGAS SL TAMSULOSIN HYDROCHLORIDE
### A III 10/18/2006 ALPLA MEXICO SA DE CV TOOTHPASTE BOTTLE AND CAP
### A II 10/11/2006 AARTI INDUSTRIES LTD VENLAFAXINE HYDROCLORIDE
### I II 10/17/2006 TEVA PHARMACEUTICAL INDUSTRIES ATORVASTATIN CALCIUM
LTD
### I III 10/12/2006 AMPACET CORP AMPACET 151334-K RED 334
Page 633
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 10/17/2006 MALLINCKRODT LLC AMPHETAMINE BASE CODE 6507
### I III 10/10/2006 3M DRUG DELIVERY SYSTEMS 3M COTRAN 9761 POLYETHYLENE TAPE
### A II 10/14/2006 SUN PHARMACEUTICAL INDUSTRIES DIVALPROEX SODIUM USP
LTD
### I II 10/20/2006 NUVIEW LIFE SCIENCES INC SODIUM IODIDE-123-02 DRY IODINE
### I III 10/18/2006 DYNIC USA CORP SPEED WAX THERMAL TRANSFER RIBBON
### I II 10/19/2006 ADARE PHARMACEUTICALS INC EUR-1046 ORALLY DISINTEGRATING TABLETS
### A III 10/4/2006 BASF SE ULTRAFORM S2320 003 PRO UNCOLORED
### A III 10/4/2006 BASF SE ULTRAFORM W2320 003 PRO UNCOLORED
### A II 6/2/2006 TRIFARMA SPA PROCHLORPERAZINE BASE
### A III 6/13/2006 CLARIANT HEALTHCARE PACKAGING CHILD RESISTANT CLOSURE
(FRANCE)
### A II 10/5/2006 LUPIN LTD LAMOTRIGINE USP (MICRONISED)
### A II 10/23/2006 MERCK KGAA DIPOTASSIUM HYDROGEN PHOSPHATE
### I II 10/23/2006 SANDOZ PRIVATE LTD ROSIGLITAZONE MALEATE
### A III 10/24/2006 MURASE GLASS CO LTD AMPOULE VIAL AND SCREW VIAL
### I V 5/25/2005 DIOSYNTH BV DOWN STREAM PROCESSING FACILITY
LOCATED IN OSS THE NETHERLANDS
### A III 10/23/2006 STELLA KUNSTSTOFFTECHNIK GMBH MEASURING CUP
### A II 10/17/2006 SPECGX LLC OXYCODONE BASE - CODE 8180
### A II 10/16/2006 ZHEJIANG CHIRAL MEDICINE CARBIDOPA
CHEMICALS CO LTD
### A III 10/16/2006 FARMACAP INDUSTRIA E COMERCIO RUBBER STOPPERS
LTDA
### I II 10/17/2006 APOTEX PHARMACHEM INC PAMIDRONIC ACID
### A II 10/20/2006 LUPIN LTD RIFABUTIN USP
### A II 10/25/2006 LUPIN LTD RABEPRAZOLE SODIUM
### A II 10/26/2006 NAVINTA LLC HYDRALAZINE HYDROCHLORIDE USP
### I II 10/24/2006 PT SINKONA INDONESIA LESTARI QUININE SULFATE USP
### A III 10/24/2006 NOLATO JAYCARE LTD 150ML BOTTLE
### A III 10/24/2006 NOLATO JAYCARE LTD SAF PAK RANGE OF BOTTLES
### A II 10/26/2006 AUROBINDO PHARMA LTD LAMOTRIGINE USP (NON-STERILE DRUG
SUBSTANCE)
### A II 10/28/2006 ADARE PHARMACEUTICALS INC EUR-1048 ORALLY DISINTEGRATING TABLETS
### I II 10/28/2006 AURO LABORATORIES LTD METFORMIN HYDROCHLORIDE
19911 A II 10/30/2006 UNION QUIMICO FARMACEUTICA SA FAMOTIDINE USP
(UQUIFA SA)
### A II 10/26/2006 IRVINE SCIENTIFIC SALES CO INC FMDF-6 (KIRIN)
### A II 10/26/2006 IRVINE SCIENTIFIC SALES CO KI NSM-12 (KIRIN)
### I II 10/25/2006 ALDRICH CHEMICAL CO ISOTEC CARBAMAZEPINE-13C1, 15N1 FOR CLINICAL
FACILITY RESEARCH
### A II 11/1/2006 CYALUME SPECIALTY PRODUCTS INC PRAMOXINE HYDROCHLORIDE USP
### I II 8/31/2006 HENAN KAIFENG PHARMACEUTICAL GENTAMICIN SULFATE
FACTORY
Page 634
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 10/30/2006 TEVA PHARMACEUTICAL INDUSTRIES PANTOPRAZOLE SODIUM
LTD
### A II 10/30/2006 HELSINN ADVANCED SYNTHESIS SA ISOTRETINOIN
### I II 11/1/2006 ZHEJIANG CHARIOTEER CARISOPRODOL USP
PHARMACEUTICAL CO LTD
### A II 11/2/2006 SANDOZ PRIVATE LTD ARIPIPRAZOLE
### I II 8/15/2006 NINGBO DOUBLE SUN GLICLAZIDE
PHARMACEUTICAL CO LTD
### A II 10/17/2006 ZHEJIANG HUAHAI PHARMACEUTICAL PAROXETINE HYDROCHLORIDE HEMIHYDRATE
CO LTD USP
### I IV 10/28/2006 CHEMCAPS LTD EMPTY HARD GELATIN CAPSULES
### A II 11/20/2006 IPCA LABORATORIES LTD METFORMIN HYDROCHLORIDE USP (PROCESS-
II)
### A II 11/2/2006 TEVA PHARMACEUTICAL INDUSTRIES ARIPIPRAZOLE
LTD
### A II 11/1/2006 ACS DOBFAR SPA CEFEPIME HYDROCHLORIDE ORAL GRADE
### I III 9/20/2006 SHANDONG PHARMACEUTICAL GLASS GLASS ( III) CONTAINERS FOR PARENTERAL
CO LTD PREPARATIONS
### A III 10/28/2006 SHANDONG PHARMACEUTICAL GLASS GLASS ( I) CONTAINERS FOR PARENTERAL
CO LTD PREPARATIONS
### A III 9/20/2006 SHANDONG PHARMACEUTICAL GLASS ELASTOMERIC CLOSURES FOR PHARMA
CO LTD PACKAGING
### A II 10/10/2006 WANBURY LTD SERTRALINE HYDROCHLORIDE FORM I
### A II 10/30/2006 AUROBINDO PHARMA LTD EFAVIRENZ USP (NON-STERILE DRUG
SUBSTANCE)
### I II 8/18/2006 CADILA PHARMACEUTICALS LTD ROPINIROLE HYDROCHLORIDE
### A II 11/3/2006 CHEMI SPA SODIUM ALENDRONATE TRIHYDRATE
### A III 10/30/2006 AMCOR FLEXIBLES BURGDORF GMBH COATED PAPER 60/ALUMINIUM 8/LLDPE 50 (SOP
50158)
### I II 11/6/2006 CAMBREX CHARLES CITY INC CARVEDILOL
### A II 11/2/2006 SAVIOR LIFETEC CORP IMIPENEM MONOHYDRATE STERILE
### A II 10/30/2006 SAVIOR LIFETEC CORP CILASTATIN SODIUM STERILE
### I III 11/1/2006 LORMAC INDUSTRIAL DISTRIBUTORS LORMAC 1P ANTI-STATIC POLYETHYLENE
LTD PRODUCTS
### I III 11/1/2006 LORMAC INDUSTRIAL DISTRIBUTORS LORMAC 1X ANTI-STATIC POLYETHYLENE
LTD PRODUCTS
### I III 11/1/2006 ULTRAAFLEX INDIA PLAIN/PRINTED ALUMINIUM FOILS
### I II 11/1/2006 IMMUTEP SA IMP321
### I II 11/8/2006 CATALENT PHARMA SOLUTIONS MICONAZOLE GELATIN ENCAPSULATED
VAGINAL SUPPOSITORY 200 MG
### A V 11/7/2006 CHARLES RIVER LABORATORIES INC CELSIS AMPISCREEN™
### A III 11/2/2006 AMPACET CORP AMPACET PRODUCT 112147 WHITE
POLYETHYLENE
### A IV 7/26/2006 HENRY H OTTENS MANUFACTURING CO NATURAL BANANA FLAVOR WONF #8763
INC
Page 635
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 11/8/2006 TARO PHARMACEUTICAL INDUSTRIES GRANISETRON HYDROCHLORIDE USP
LTD
### A II 11/1/2006 YUNG ZIP CHEMICAL IND CO LTD ACYCLOVIR (PROCESS II)
### I II 11/6/2006 SUN PHARMACEUTICAL INDUSTRIES ARIPIPRAZOLE
LTD
### A III 11/9/2006 SCHOTT BRASIL LTDA GLASS PRODUCTS
### I II 11/2/2006 JIANGSU TASLY DIYI PHARMACEUTICAL FLUTAMIDE
CO LTD
### A IV 11/7/2006 BIO-CIDE INTERNATIONAL INC SODIUM CHLORITE EXCIPIENT INGREDIENT
### A III 11/13/2006 INYECCIONES PLASTICAS DE PET INJECTED FLAVOR BARRIER INSERT AND
QUERETARO SA DE CV HDPE INJECTED SHOULDER FOR TOOTHPASTE
BOTTLE
### A IV 10/30/2006 FREUND CORP NONPAREIL-108
### I III 10/30/2006 REXAM PHARMA SAS SEABISCUIT RANGE
### A II 11/4/2006 IND SWIFT LABORATORIES LTD DONEPEZIL HYDROCHLORIDE MONOHYDRATE
USP
### A II 11/13/2006 APOTEX PHARMACHEM INC ARIPIPRAZOLE USP
### A III 11/14/2006 ARTE CORP SINGLE CHAMBER PREFILLABLE SYRINGE
### A II 11/7/2006 AUROBINDO PHARMA LTD DOXAZOSIN MESYLATE USP (NON-STERILE
DRUG SUBSTANCE)
### A II 11/14/2006 ORCHID PHARMA LTD CEFIXIME (PROCESS 2)
### I II 11/14/2006 DR REDDYS LABORATORIES LTD ALFUZOSIN HYDROCHLORIDE
### I IV 11/13/2006 FONA INTERNATIONAL INC 825.609 N-C CHERRY BERRY FLAVOR ARTIFICIAL
### I IV 11/13/2006 FONA INTERNATIONAL INC 935.195 N-C COOLING FLAVOR, NATURAL
### I IV 11/13/2006 FONA INTERNATIONAL INC 848.0001U N-C EUCALYPTUS FLAVOR NATURAL
### I II 11/10/2006 FARCHEMIA SRL TRIMETHOBENZAMIDE HCI
### A II 11/15/2006 UBE INDUSTRIES LTD BEPOTASTINE BESILATE
### A II 11/15/2006 ORCHID PHARMA LTD GRANISETRON HYDROCHLORIDE
### A II 11/3/2006 JUBILANT GENERICS LTD RISEDRONATE SODIUM HEMIPENTAHYDRATE-
USP
### A III 11/14/2006 PHILLIPS 66 POLYPROPYLENE GRADES
### I II 11/16/2006 DR REDDYS LABORATORIES LTD PAROXETINE HYDROCHLORIDE HEMIHYDRATE
### A II 11/15/2006 SAI LIFE SCIENCES LTD EPOPROSTENOL SODIUM, NON-STERILE
### A II 11/16/2006 GRANULES INDIA LTD COMPRESSO PAP 90 CPC
### I II 11/8/2006 SARACA LABORATORIES LTD RANITIDINE HCI (FORM-I)
### I II 11/3/2006 OLON SPA DULOXETINE HYDROCHLORIDE
### I II 11/3/2006 OLON SPA FUROSEMIDE
### I III 11/15/2006 PPG INDUSTRIES INC PPG2004877
### I III 11/13/2006 ASHLAND INC FLEXCRYL AF2027
### A II 12/13/2006 CHEMWERTH INC FOMEPIZOLE
### A II 11/20/2006 LEK PHARMACEUTICALS DD TACROLIMUS
### I II 10/10/2006 CHANGZHOU SIYAO FLUOXETINE HYDROCHLORIDE
PHARMACEUTICALS CO LTD
### I II 11/17/2006 HOVIONE FARMACIENCIA SA FLUMETHASONE
Page 636
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 10/10/2006 TAI HENG INDUSTRY CO LTD ARIPIPRAZOLE
### A II 11/16/2006 AUROBINDO PHARMA LTD CEPHALOTHIN ACID (NON-STERILE DRUG
SUBSTANCE INTERMEDIATE)
### A II 11/17/2006 NEULAND LABORATORIES LTD ENALAPRIL MALEATE USP
### I II 10/19/2006 MS MARKSANS PHARMA LTD METFORMIN HYDROCHLORIDE USP
### A II 11/15/2006 WANBURY LTD DIPHENHYDRAMINE CITRATE
### A II 11/22/2006 CIPLA LTD TELMISARTAN USP
### A II 11/22/2006 HETERO LABS LTD LOSARTAN POTASSIUM (FORM 1)
### A II 11/23/2006 ITF CHEMICAL LTDA ROSIGLITAZONE MALEATE
### A II 11/22/2006 DR REDDYS LABORATORIES LTD CANDESARTAN CILEXETIL USP
### A II 11/22/2006 MOEHS IBERICA SL MEPIVACAINE HYDROCHLORIDE
### A III 11/13/2006 AMPACET CORP AMPACET 163058 DARK BLUE POLYPROPYLENE
MASTERBATCH
### A II 11/20/2006 CORDEN PHARMA BERGAMO SPA MESALAMINE HIGH DENSITY
### I III 11/17/2006 RICON COLORS INC BLUE REFLEX FDA CPP-BL-3578-1
### A II 11/24/2006 OLON SPA FENOFIBRIC ACID
### A II 11/27/2006 DR REDDYS LABORATORIES LTD VORICONAZOLE USP
### A II 11/27/2006 DR REDDYS LABORATORIES LTD ATORVASTATIN CALCIUM (FORM P) USP,
SEMICRYSTALLINE
### I II 11/17/2006 AUROBINDO PHARMA LTD CEFTAZIDIME FOR INJECTION USP (STERILE
BULK)
### I II 11/21/2006 WANBURY LTD IBUPROFEN DC GRADE-65%
### A III 9/21/2006 THE CONTROL GROUP LAMINATED AND PRINTED PACKAGING FILMS
### I II 11/23/2006 PALL BIOSEPRA DIVISION OF PALL BIOSEPRA PPAHYPERCEL SORBENT
FRANCE SA
### I II 11/23/2006 PALL BIOSEPRA DIVISION OF PALL BIOSEPRA HEA HYPERCEL
FRANCE SA
### A II 11/29/2006 CIPLA LTD TENOFOVIR DISOPROXIL FUMARATE
### A II 11/30/2006 GADOR SA 17-METHYLNORETHINDRONE OXIME
(NORELGESTROMIN)
### I III 11/22/2006 COLORS FOR PLASTICS INC THERMOPLASTIC RESIN COLORANT
MASTERBATCH W04200
### I II 11/30/2006 SCORA SA SCORALITE AND SCORALITE LOW LEAD
CALCIUM CARBONATE
### A II 11/30/2006 DR REDDYS LABORATORIES LTD PRIMIDONE
### A II 12/1/2006 DR REDDYS LABORATORIES LTD IRBESARTAN USP
### I II 11/30/2006 PHARMACEUTICAL WORKS POLPHARMA SULFADIMETHOXINE SODIUM
SA
### A II 11/30/2006 INDUSTRIALE CHIMICA SRL BUDESONIDE USP
20011 A II 11/29/2006 APICORE US LLC PHENOXYBENZAMINE HYDROCHLORIDE USP
### A II 11/24/2006 JUBILANT GENERICS LTD CITALOPRAM HYDROBROMIDE (DGR) USP
### I II 12/5/2006 ORCHID CHEMICALS AND AZTREONAM
PHARMACEUTICALS LTD
### A II 12/5/2006 HETERO LABS LTD EFAVIRENZ (PROCESS I)
### A III 11/28/2006 POLYONE CORP CC00001986DR 10031450 ALCOA WHITE
Page 637
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 11/26/2006 INEOS STYROLUTION EUROPE GMBH TERLUX® HD 2812
### A III 11/25/2006 ISHAN INDUSTRIES PET BOTTLES
### A III 11/25/2006 ISHAN INDUSTRIES COLLAPSIBLE ALUMINIUM TUBES
### I II 12/9/2006 SANMAR SPECIALITY CHEMICALS LTD LETROZOLE USP
### A II 12/8/2006 SCINOPHARM TAIWAN LTD DOCETAXEL USP
### A II 12/8/2006 SIEMENS MOLECULAR IMAGING STERILE NON-PYROGENIC 3'-DEOXY-3'-
[18F]FLUOROTHYMIDINE ([18F]FLT)
### A II 11/21/2006 ALEMBIC PHARMACEUTICALS LTD CLARITHROMYCIN USP
### I III 11/21/2006 APEX PLASTICS INC PACKAGING BLOW MOLDED BOTTLE
### I II 10/31/2006 STANDARD CHEM AND PHARM CO LTD TERAZOSIN HYDROCHLORIDE
### A III 12/4/2006 NATIONAL PLASTICS COLOR INC COLORANT
### I III 11/27/2006 BERRY PLASTICS CORP TAPES AND MS-H-2530SR
COATINGS DIV
### A II 12/10/2006 NOF CORP METHOXYPOLY(ETHYLENE GLYCOL)-
PROPYLALDEHYDE MW20000
### I III 12/6/2006 ROHM AND HAAS CO ROBOND PS-8136
### A II 12/4/2006 AUROBINDO PHARMA LTD ALENDRONATE SODIUM USP (NON-STERILE
DRUG SUBSTANCE)
### I II 12/7/2006 FIS FABBRICA ITALIANA SINTETICI SPA FIS0127
### A II 12/13/2006 HERAEUS DEUTSCHLAND GMBH AND ARSENIC TRIOXIDE USP
CO KG
### A II 12/14/2006 ANJAN DRUG PRIVATE LTD VALPROIC ACID USP
### A II 12/14/2006 DR REDDYS LABORATORIES LTD MONTELUKAST SODIUM USP
### A II 12/14/2006 ANJAN DRUG PRIVATE LTD DIVALPROEX SODIUM USP
### A II 12/19/2006 IPCA LABORATORIES LTD GLIMEPIRIDE USP
### A II 12/11/2006 WANBURY LTD METHOXSALEN
### A II 12/13/2006 TEVA PHARMACEUTICAL INDUSTRIES EZETIMIBE
LTD
### A II 12/12/2006 MERCK AND CIE L-METHYLFOLATE CALCIUM
### A II 12/14/2006 TEVA PHARMACEUTICAL INDUSTRIES MUPIROCIN CALCIUM
LTD
### A III 11/24/2006 AMCOR FLEXIBLES HORSENS PETP12/ALU7/PETP12/LLDPE60
### I II 12/11/2006 WANBURY LTD IBUPROFEN DC GRADE-90%
### A III 12/14/2006 NOLATO JAYCARE LTD PUSH-LOK RANGE OF CLOSURES
### A II 12/15/2006 SANDOZ PRIVATE LTD QUETIAPINE FUMARATE
### I II 12/16/2006 SUN PHARMACEUTICAL INDUSTRIES CILASTATIN ACID
LTD
### I II 12/16/2006 SUN PHARMACEUTICAL INDUSTRIES BICYCLOKETONE DRUG SUBSTANCE
LTD INTERMEDIATE
### I II 12/16/2006 SUN PHARMACEUTICAL INDUSTRIES IMIPENEM TECHNICAL DRUG SUBSTANCE
LTD INTERMEDIATE
### A III 6/26/2006 EMS CHEMIE NORTH AMERICA INC GRILFLEX ELG 5930 NATURAL
### I III 12/15/2006 STELLA KUNSTSTOFFTECHNIK GMBH PRIMARY PACKAGE CONSISTING OF BOTTLE,
PLUG AND BRUSH CLOSURE
### A II 12/14/2006 AARTI DRUGS LTD NIACIN
Page 638
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/16/2006 JUBILANT GENERICS LTD ZOLEDRONIC ACID
### I II 12/18/2006 LEK PHARMACEUTICALS DD CANDESARTAN CILEXETIL
### A II 12/19/2006 HERAEUS DEUTSCHLAND GMBH AND OXALIPLATIN PROCESS HER-2 USP
CO KG
### I II 12/8/2006 SAI PHYTOCEUTICALS PVT LTD CAMPTOTHECIN
### I IV 12/19/2006 FONA INTERNATIONAL INC 833.046 NATURAL COFFEE CONCENTRATE
### I IV 12/19/2006 FONA INTERNATIONAL INC 807.002 NAT. MIXED BERRY FLAVOR WONF
### I II 5/31/2006 NUVIEW LIFE SCIENCES INC INDIUM CHLORIDE (111-IN) RADIOCHEMICAL
### A II 12/19/2006 ASPEN OSS BV VECURONIUM BROMIDE
### A II 11/23/2006 S M HERBALS PVT LTD CAMPTOTHECIN [CAS NO. 7689-03-4]
### A II 12/19/2006 CHONGQING DAXIN PHARMACEUTICAL LOVASTATIN
CO LTD
### I II 12/8/2006 SAI PHYTOCEUTICALS PVT LTD 10-DEACETYL BACCATIN-III
### I II 12/13/2006 WATSON PHARMA PRIVATE LTD TAZAROTENE
### A II 12/13/2006 TEVA PHARMACEUTICAL INDUSTRIES ADAPALENE USP
LTD
### A III 12/14/2006 POLYONE CORP VC1000388260 GEON XV3432 TRANS 9000
### A II 12/21/2006 CILAG AG ALCAFTADINE (R89674) DRUG SUBSTANCE
### I II 12/14/2006 SUN PHARMACEUTICAL INDUSTRIES LAMIVUDINE USP
LTD
### A II 12/20/2006 TEVA PHARMACEUTICAL INDUSTRIES ROCURONIUM BROMIDE
LTD
### I II 12/20/2006 TEVA PHARMACEUTICAL INDUSTRIES ATORVASTATIN CALCIUM
LTD
### A II 5/18/2007 APOTEX PHARMACHEM INC ATOMOXETINE HYDROCHLORIDE
### A II 5/15/2007 WOCKHARDT LTD ADENOSINE USP
### A II 12/20/2006 TEVA PHARMACEUTICAL INDUSTRIES MYCOPHENOLATE MOFETIL DRUG SUBSTANCE
LTD
### A II 12/20/2006 CHEMPACIFIC CORP MELPHALAN DRUG SUBSTANCE
### I II 12/18/2006 SHIJIAZHUANG PHARMACEUTICAL AZITHROMYCIN USP (API)
GROUP HUASHENG PHARMA CO LTD
### I II 12/22/2006 RANBAXY LABORATORIES LTD VENLAFAXINE HYDROCHLORIDE
### A II 12/26/2006 SANDOZ GMBH CEFPODOXIME PROXETIL
### A II 11/9/2006 KYONGBO PHARMACEUTICAL CO LTD CEFTRIAXONE SODIUM STERILE
### A V 12/20/2006 BIOPHARMA SRL BIOPHARMA SRL MANUFACTURING IN ROMA
ITALY
### A II 12/22/2006 CARDINAL HEALTH 414 LLC CARDINAL TETRAKIS (2-METHOXYISOBUTYLISONITRILE)
HEALTH NUCLEAR PHARMACY COPPER (I) TETRAFLUOROBORATE DRUG
SERVICES SUBSTANCE
### I III 12/20/2006 3M DRUG DELIVERY SYSTEMS SCOTCHPAK™ 9748 RELEASE LINER
### A II 10/17/2006 ZHEJIANG HUAHAI PHARMACEUTICAL ESCITALOPRAM OXALATE USP
CO LTD
### A II 12/21/2006 SYNTHON BV TAMSULOSIN HYDROCHLORIDE
### A III 12/22/2006 SRC MEDICAL INC DROPPER ASSEMBLIES
### A IV 12/22/2006 FUJI CHEMICAL INDUSTRIES CO LTD F-MELT C (EXCIPIENT)
Page 639
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 12/21/2006 ZHEJIANG XINHUA PHARMACEUTICAL BUPROPION HYDROCHLORIDE
CO LTD
### I II 12/27/2006 SUN PHARMACEUTICAL INDUSTRIES IMIPENEM USP (STERILE)
LTD
### I II 12/27/2006 RANBAXY LABORATORIES LTD STAVUDINE USP
### I II 12/27/2006 RANBAXY LABORATORIES LTD NEVIRAPINE USP (ANHYDROUS) (NON-STERILE
BULK) DRUG SUBSTANCE
### I II 12/27/2006 SUN PHARMACEUTICAL INDUSTRIES CILASTATIN SODIUM USP (STERILE)
LTD
### I II 12/27/2006 SUN PHARMACEUTICAL INDUSTRIES SODIUM BICARBONATE USP (STERILE)
LTD
### I II 12/27/2006 RANBAXY LABORATORIES LTD CANDESARTAN CILEXETIL (NON STERILE BULK)
DRUG SUBSTANCE
### I III 12/26/2006 KUNSTSTOFFWERK KREMSMUNSTER PP 28 CHILD RESISTANT TAMPER EVIDENT
GMBH SCREW CAPS
### A II 12/21/2006 AMINO CHEMICALS LTD TOLTERODINE TARTRATE
### I II 12/6/2006 JIANGSU JIWA RINTECH CITALOPRAM HYDROBROMIDE USP
PHARMACEUTICAL CO LTD
### A II 12/23/2006 WOCKHARDT LTD TAMSULOSIN HYDROCHLORIDE
### A II 12/28/2006 UQUIFA MEXICO SA DE CV TOLTERODINE TARTRATE
### A II 12/27/2006 AARTI INDUSTRIES LTD BENAZEPRIL HYDROCHLORIDE
### I II 12/28/2006 EMERALD KALAMA CHEMICAL LLC BENZYL ALCOHOL NF-API
### A II 12/28/2006 FRESENIUS KABI ONCOLOGY LTD BICALUTAMIDE
### A II 12/29/2006 DR REDDYS LABORATORIES LTD ALENDRONATE SODIUM
### I II 12/29/2006 JOHNSON MATTHEY PHARMACEUTICAL 2-(1-AMINO-1-METHYL-ETHYL)-HYDROXY-1-
MATERIALS METHYL-6-OXO-1,6-DIHYDROPYRIMIDINE-4-
CARBOXYLIC ACID 4-FLUORO-BENZYLAMIDE
(ECB)
### I II 11/29/2006 NORTHEAST GENERAL LEVOCARNITINE
PHARMACEUTICAL FACTORY
### A II 12/29/2006 CAMBREX CHARLES CITY INC MMB4 DIMESYLATE
### I II 12/28/2006 AGNO PHARMA USA SULINDAC
### I II 12/27/2006 AMINO CHEMICALS LTD ZIPRASIDONE HYDROCHLORIDE ANHYDROUS
### I II 12/27/2006 AMINO CHEMICALS LTD ADAPALENE
### A II 1/2/2007 MYLAN LABORATORIES LTD STAVUDINE USP
### A II 1/3/2007 MYLAN LABORATORIES LTD TENOFOVIR DISOPROXIL FUMARATE
### A II 1/3/2007 MYLAN LABORATORIES LTD TELMISARTAN USP
20110 A II 1/4/2007 SMS PHARMACEUTICALS LTD ZOLMITRIPTAN
20111 A III 1/2/2007 WACKER CHEMICAL CORP VINNOL H 40/43
20112 A II 1/3/2007 MYLAN LABORATORIES LTD AMLODIPINE BESYLATE USP
20113 A II 12/30/2006 AUROBINDO PHARMA LTD TERAZOSIN HYDROCHLORIDE USP (NON-
STERILE DRUG SUBSTANCE)
20114 A II 1/4/2007 UQUIFA ITALIA SPA PYRANTEL TARTRATE ZEOLEX
20115 I IV 12/15/2006 CRODA INC TWEEN 80 HP-LQ-(MH)
Page 640
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
20116 A II 1/3/2007 WAVELENGTH ENTERPRISES LTD PRAMIPEXOLE DIHYDROCHLORIDE
MONOHYDRATE
20117 I II 12/15/2006 APOTEX PHARMACHEM INC ATORVASTATIN CALCIUM GRANULATION
20118 I II 12/19/2006 SANOFI AVENTIS DEUTSCHLAND GMBH ARTICAINE HYDROCHLORIDE
20119 A II 1/5/2007 ORCHID PHARMA LTD CETIRIZINE DIHYDROCHLORIDE
### A II 12/11/2006 TAIWAN BIOTECH CO LTD BISOPROLOL FUMARATE
### A II 1/9/2007 UNIMARK REMEDIES LTD 7-AMINO-3-CHLORO-3-CEPHEM-4-CARBOXYLIC
ACID (7ACCA)
### A II 12/27/2006 AUROBINDO PHARMA LTD GABAPENTIN USP (NON-STERILE DRUG
SUBSTANCE)
### A II 1/8/2007 FERTIN PHARMA AS NICOTINE POLACRILEX USP
### I II 1/7/2007 DIVIS LABORATORIES LTD TPE ALCOHOL
### I II 1/8/2007 CADILA HEALTHCARE LTD SIMVASTATIN ( LOVASTATIN ROUTE)
### A II 11/16/2006 PCI SYNTHESIS DISULFIRAM USP
### A II 1/9/2007 DR REDDYS LABORATORIES LTD RANITIDINE HYDROCHLORIDE [FORM-2]
### I II 12/30/2006 AUROBINDO PHARMA LTD AMOXICILLIN SODIUM (STERILE) BULK
### I II 1/11/2007 APOTEX PHARMACHEM INDIA PVT LTD LAMOTRIGINE
### A II 1/8/2007 CADILA HEALTHCARE LTD PRAMIPEXOLE DIHYDROCHLORIDE USP
(MONOHYDRATE)
### A V 1/9/2007 COLORCON INC SUPPLEMENTARY INFORMATION FOR
COLORCON PRODUCT STARCAP 1500 CO-
PROCESSED STARCH EXCIPIENT
### A III 12/27/2006 EXECHON CONTAINERS AND CLOSURES FOR
PHARMACEUTICALS DOSAGE FORMS
Page 641
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/31/2006 BIO TECHNOLOGY GENERAL ISRAEL SOMATROPIN (RECOMBINANT HUMAN GROWTH
LTD HORMONE) API
### A II 1/12/2007 USV PRIVATE LTD IRBESARTAN USP
### A II 1/12/2007 SANMAR SPECIALITY CHEMICALS LTD COLCHICINE USP NON-STERILE BULK DRUG
SUBSTANCE
### I II 1/9/2007 ZHEJIANG LIAOYUAN 1-(3-HYDROXYMETHYLPYRIDYL-2)-2-PHENYL-4-
PHARMACEUTICALS CO LTD METHYLPIPERAZINE (M3 INTERMEDIATE FOR
MIRTAZAPINE)
### I II 4/2/2007 TAI HENG INDUSTRY CO LTD MEMANTINE HYDROCHLORIDE
### A II 1/5/2007 JUBILANT GENERICS LTD CETIRIZINE DIHYDROCHLORIDE USP
### A III 1/17/2007 MEGA PUMPS LP STANDARD AND MINI PUMP DISPENSERS
### A III 1/4/2007 COIM USA INC PRIMER PR-109
### I III 1/4/2007 BERRY PLASTICS CORP PRODUCT 60119-21
### A IV 1/12/2007 HENRY H OTTENS MANUFACTURING CO NATURAL AND ARTIFICIAL MINT FLAVOR #8985-B
INC
### A III 1/11/2007 AMCOR FLEXIBLES BURGDORF GMBH COATED PAPER 50/ALUMINIUM 9/PAN-BAREX 28
(SOP 50911)
### I II 2/19/2009 CIPLA LTD VINORELBINE TARTRATE USP
### I II 6/29/2007 CIPLA LTD VENLAFAXINE HYDROCHLORIDE FORM B
### I II 1/17/2007 CIPLA LTD SIBUTRAMINE HYDROCHLORIDE
### A II 3/16/2007 CIPLA LTD RISEDRONATE SODIUM HEMI PENTAHYDRATE
USP
### I II 1/17/2007 CIPLA LTD RALOXIFENE HYDROCHLORIDE
### I II 1/17/2007 CIPLA LTD QUETIAPINE FUMERATE
### A II 9/6/2007 CIPLA LTD PERINDOPRIL ERBUMINE MONOHYDRATE
### A II 3/13/2008 CIPLA LTD OXALIPLATIN PH. EUR.
### A II 1/17/2007 CIPLA LTD OMEPRAZOLE SODIUM
### I II 7/31/2008 CIPLA LTD MOXIFLOXACIN HYDROCHLORIDE PH. EUR.
### A II 12/20/2007 CIPLA LTD MOMETHASONE FUROATE USP
### A II 4/24/2008 CIPLA LTD LUMEFANTRINE
### A II 1/17/2007 CIPLA LTD LEVOCETIRIZINE DIHYDROCHLORIDE USP
### A II 6/26/2008 CIPLA LTD LETROZOLE USP
### I II 12/3/2008 CIPLA LTD IRBESARTAN
### A II 4/24/2007 CIPLA LTD FORMOTEROL FUMARATE USP
### A II 5/6/2009 CIPLA LTD DUTASTERIDE
### I II 4/24/2007 CIPLA LTD CYPROTERONE ACETATE BP/PH.EUR.
### I II 6/26/2008 CIPLA LTD AZELASTINE HYDROCHLORIDE BP/PH.EUR
### I II 4/24/2008 CIPLA LTD ARTEMETHER
### A II 4/15/2008 CIPLA LTD ARTESUNATE
### I II 7/16/2007 CIPLA LTD ARIPIPRAZOLE
### I II 3/27/2007 CIPLA LTD ADEFOVIR DIPIVOXIL
### A III 2/6/2007 PRIORITY PLASTICS INC MANUFACTURER OF PLASTIC BLOW MOLDED
CONTAINERS AND OTHER PRODUCTS
### I II 1/19/2007 DR REDDYS LABORATORIES LTD ZOLMITRIPTAN
Page 642
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 1/12/2007 SUN PHARMACEUTICAL INDUSTRIES IRINOTECAN HYDROCHLORIDE TRIHYDRATE
LTD
### I II 1/16/2007 EMCURE PHARMACEUTICALS LTD EFAVIRENZ USP
### A V 1/22/2007 NOVO NORDISK PHARMACEUTICAL STERILIZATION VALIDATION PACKAGE
INDUSTRIES LP
### A II 1/19/2007 LUPIN LTD IRBESARTAN USP
### A II 1/18/2007 INDUSTRIALE CHIMICA SRL FORMOTEROL FUMARATE DIHYDRATE USP
### A III 1/18/2007 3M CO PACKAGING MATERIAL (FPO)
### A III 1/5/2007 3M CO PACKAGING MATERIAL (PB009146/147)
### A III 1/15/2007 IMPRESS CONTAINERS CO ALUMINIUM COLLAPSIBLE TUBES
### A II 1/12/2007 ZHEJIANG CHARIOTEER ACYCLOVIR USP (API)
PHARMACEUTICAL CO LTD
### I II 1/23/2007 TONIRA PHARMA LTD TRAMADOL HYDROCHLORIDE
### I II 1/24/2007 AMINO CHEMICALS LTD PANTOPRAZOLE SODIUM SESQUIHYDRATE
### A II 1/23/2007 ORCHID PHARMA LTD DIVALPROEX SODIUM
### I II 1/16/2007 BIOCON LTD ATORVASTATIN MAGNESIUM
### I II 1/18/2007 ZHEJIANG JIUZHOU PHARMACEUTICAL ATOMOXETINE HYDROCHLORIDE
CO LTD
### I II 1/5/2007 ALP PHARM ALLIANCEPHARM SULPIRIDE EP
### A II 1/23/2007 SUN PHARMACEUTICAL INDUSTRIES BUPROPION HYDROCHLORIDE USP
LTD
20211 A II 1/16/2007 AUROBINDO PHARMA LTD AMPICILLIN SODIUM USP (STERILE) BULK
### A II 1/17/2007 AURISCO PHARMACEUTICAL CO LTD FLUTICASONE PROPIONATE USP
### A II 1/29/2007 SIEGFRIED USA LLC CODEINE PHOSPHATE USP
### I II 1/24/2007 MEDICHEM SA MED - 201650/E
### A III 1/11/2007 AMPACET CORP 11171-A WHITE POLYETHYLENE MASTERBATCH
### A IV 1/15/2007 HENRY H OTTENS MANUFACTURING CO NATURAL AND ARTIFICIAL MIXED TUTTI FRUTTI
INC FLAVOR #12346-B
### I IV 1/23/2007 FONA INTERNATIONAL INC 913.004 N-C NAT & ART SPEARMENT FLAVOR
### A II 1/29/2007 TEVA PHARMACEUTICAL INDUSTRIES OLANZAPINE USP
LTD
### I II 1/30/2007 PERRIGO API LTD EXEMESTANE
### I II 1/31/2007 NUTRITION 21 INC CHROMAX CHROMIUM PICOLINATE
### A IV 1/31/2007 CORDEN PHARMA SWITZERLAND LLC N-(CARBONYL-METHOXYPOLYETHYLENE
GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-
PHOSPHOETHANOLAMINE SODIUM SALT
(MPEG-2000-DSPE)
### A II 1/31/2007 GLENMARK PHARMACEUTICALS LTD ESOMEPRAZOLE
### A II 1/26/2007 POLYMED THERAPEUTICS INC IRINOTECAN HYDROCHLORIDE TRIHYDRATE
### A III 1/24/2007 FUJIMORI KOGYO CO LTD TRF-7
### I II 1/29/2007 ZHEJIANG JINGXIN PHARMACEUTICAL LEVOFLOXACIN HEMIHYDRATE
CO LTD
### I II 1/31/2007 RELIABLE BIOPHARMACEUTICAL CORP DTPA MANNOSYL DEXTRAN (A.K.A.
TILMANOCEPT)
### A II 1/29/2007 ERREGIERRE SPA RIVASTIGMINE TARTRATE
Page 643
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 1/9/2007 DAIWA SPECIAL GLASS CO LTD GLASS BOTTLE
### A III 1/19/2007 AMPACET CORP 111818 WHITE POLYETHYLENE MASTERBATCH
### I IV 1/26/2007 HENRY H OTTENS MANUFACTURING CO NATURAL AND ARTIFICIAL CITRUS BERRY
INC FLAVOR #14924
### A II 1/27/2007 IND SWIFT LABORATORIES LTD NATEGLINIDE USP
### A II 1/31/2007 FARMABIOS SPA MIVACURIUM CHLORIDE
### A IV 1/31/2007 DDP SPECIALTY ELECTRONIC SILASTIC™7-4870 BIOMEDICAL GRADE LIQUID
MATERIALS US 9 LLC SILICONE RUBBER
### A II 1/29/2007 BACHEM SA ETOMIDATE
### I III 1/22/2007 BOREALIS AS BOREALIS POLYPROPYLENE BORSOFT
SC220CF
### I III 1/22/2007 BOREALIS AS BOREALIS POLYPROPYLENE STERIPEEL
WD170CF
### I III 1/22/2007 BOREALIS AG SD233CF
### I III 1/22/2007 BOREALIS AG SA233CF
### I III 1/22/2007 BOREALIS AG BOREALIS POLYPROPYLENE BORSEAL TD210BF
A TERPOLYMER FOR BOPP FILM APPLICATIONS
Page 644
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 1/8/2007 ZHEJIANG GUOBANG PHARMACEUTICAL AZITHROMYCIN MONOHYDRATE
CO LTD
### A II 1/8/2007 HEBEI HUARONG PHARMACEUTICAL CO MECOBALAMIN
LTD
### I II 2/12/2007 LUPIN LTD STERILE CEFEPIME HYDROCHLORIDE USP
### I III 2/9/2007 BASELL USA INC PRO-FAX HL232R
### A II 2/7/2007 ST GOBAIN PERFORMANCE PLASTICS SANITECH STHT-C HIGH PURITY SILICONE
CORP TUBING
### A II 2/10/2007 SUN PHARMACEUTICAL INDUSTRIES BICALUTAMIDE USP
LTD
### I II 2/9/2007 PAION UK LTD MORPHINE-6-BETA-D-GLUCURONIDE
### I II 2/9/2007 LUPIN LTD STERILE CEFEPIME HYDROCHLORIDE
(BUFFERED)
### I II 1/29/2007 FIS FABBRICA ITALIANA SINTETICI SPA TERBINAFINE HCL
### I III 1/24/2007 HEINKE TECHNOLOGY INC PACKAGING PRE-FILED VAGINAL APPLICATOR
### I II 2/13/2007 WANBURY LTD ATENOLOL
### A II 2/15/2007 SYMED LABS LTD LINEZOLID (FORM III)
### I II 2/13/2007 HETERO DRUGS LTD RITONAVIR, USP (FORM I), PROCESS I
### A II 2/13/2007 HETERO DRUGS LTD PANTOPRAZOLE SODIUM SESQUIHYDRATE
### A II 2/9/2007 SAFC BIOSCIENCES INC EX CELL VPRO (MODIFIED) SERUM FREE W/O L-
GLUTAMINE W/O COD LIVER OIL
### A II 1/10/2007 LIVZON GROUP (NINGXIA) MEVASTATIN (NON-STERILE, BULK FORM)
PHARMACEUTICAL CO LTD
### I II 2/10/2007 ZHEJIANG JIUZHOU PHARMACEUTICAL TRANS-(-)-PAROXOL
CO LTD
### I II 2/6/2007 SEVEN STAR PHARMACEUTICAL CO LTD METHOCARBAMOL DC 90%
Page 646
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 2/20/2007 CONSOLIDATED BOTTLE CORP STERILE PROCESSING FACILITY LOCATED IN
COUNTY ANTRIM, NORTHERN IRELAND
### A II 3/2/2007 DR REDDYS LABORATORIES LTD VALSARTAN
### I III 2/20/2007 POLIMERI EUROPA FRANCE RIBLENE FM34
### I III 2/20/2007 POLIMERI EUROPA FRANCE RIBLENE FH10
### A III 2/22/2007 POLYONE CORP CC00015845DR/WE 5026002KMBC PEROXIDE
BROWN
### I II 3/3/2007 SHANDONG WEIFANG GEIBROZIL
PHARMACEUTICAL FACTORY CO LTD
### I V 2/28/2007 NANOINK INC PHARMACEUTICAL BRAND PROTECTION AND
ANTI-COUNTERFEITING INSTRUMENTATION AND
PROCESS
### I II 3/6/2007 DR REDDYS LABORATORIES LTD IRINOTECAN HYDROCHLORIDE TRIHYDRATE
### A II 2/28/2007 SUN PHARMACEUTICAL INDUSTRIES ENTACAPONE
LTD
### A II 2/28/2007 MERCK AND CIE CALCIUM LEVOFOLINATE PENTAHYDRATE
### I II 2/28/2007 SAFC PHARMA SODIUM METAARSENITE
### A IV 3/6/2007 COLORCON STARCAP 1500 CO-PROCESSED STARCH
EXCIPIENT
### I II 3/7/2007 PERRIGO API LTD PRAMIPEXOLE BASE
### I II 3/8/2007 ORCHID CHEMICALS AND CEFUROXIME SODIUM (STERILE)
PHARMACEUTICALS LTD
### A II 3/9/2007 NIPPON ZOKI PHARMACEUTICAL CO LTD NEUTROTROPIN TABLET
### I III 4/2/2007 HEINKE TECHNOLOGY INC SIDE DISPERSION PRE-FILLED VAGINAL
APPLICATOR
### I III 3/8/2007 GERRESHEIMER BOLESLAWIEC S A GLASS AMPOULES, VIALS, AND SAMPLES MADE
FROM GLASS TUBES FOR VARIOUS PRODUCTS
OF HEALTH CARE SECTIONS UP TO CONTENTS
OF 30 ML
### A II 4/25/2007 NOF CORP DISTEAROYL PHOSPHATIDYL GLYCEROL
SODIUM SALT (DSPG-NA)
### A II 4/23/2007 MALLADI DRUGS AND PHENYLEPHRINE BITARTRATE
PHARMACEUTICALS LTD
### A II 4/24/2007 DISHMAN CARBOGEN AMCIS LTD BISACODYL
### A III 4/18/2007 ST GOBAIN PERFORMANCE PLASTICS POLYESTER FILM C/1/S WITH 8005 SILICONE
RELEASE COATING
### A II 4/27/2007 POLYPEPTIDE SA THYMOSIN-A-1, DRUG SUBSTANCE
### A II 4/27/2007 ERCROS SA FUSIDIC ACID
### I II 3/19/2007 QILU ANTIBIOTICS PHARMACEUTICAL STERILE CEFOTAXIME SODIUM
CO LTD
### A II 12/28/2006 QILU ANTIBIOTICS PHARMACEUTICAL CEFTAZIDIME FOR INJECTION
CO LTD
### A II 12/30/2006 QILU ANTIBIOTICS PHARMACEUTICAL STERILE CEFTRIAXONE SODIUM
CO LTD
### A II 4/24/2007 ERREGIERRE SPA TOLTERODINE TARTRATE
Page 651
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 4/27/2007 BESPAK DIV CONSORT MEDICAL PLC BK361003MTA PHARMACEUTICAL METERING
VALVE
### A II 12/20/2006 QILU ANTIBIOTICS PHARMACEUTICAL STERILE CEFOPERAZONE SODIUM
CO LTD
### I II 12/28/2006 QILU ANTIBIOTICS PHARMACEUTICAL STERILE CEFAZOLIN SODIUM
CO LTD
### I III 4/17/2007 CHESAPEAKE PLASTICS PACKAGING PACKAGING MATERIAL
KUNSHAN CO LTD
### A II 4/26/2007 MACCO ORGANIQUES SRO MAGNESIUM CHLORIDE HEXAHYDRATE
### I IV 4/24/2007 MASTERTASTE SPA 06201.1 DRYCELL YOGURT FLAVOUR
### I IV 4/24/2007 MASTERTASTE SPA 06300.1 DRYCELL ORANGE FLAVOUR
### I IV 4/24/2007 MASTERTASTE SPA B03373F.1 ORANGE FLAVOUR
### A II 4/27/2007 MITSUI NORIN CO LTD POLYPHENON E (USAN: SINECATECHINS)
### I V 4/30/2007 CATALENT PHARMA SOLUTIONS INC CARDINAL HEALTH NORTH RALEIGH STERILE
MANUFACTURING FACILITY
### I II 4/30/2007 TEVA PHARMACEUTICAL INDUSTRIES IBANDRONATE SODIUM
LTD
### I II 4/23/2007 WANBURY LTD CLOPIDOGREL BISULFATE
### I II 4/30/2007 AARTI DRUGS LTD LORATADINE
### A IV 4/24/2007 DUPONT NUTRITION USA INC CALCIUM ALGINATE
### A II 4/26/2007 SUVEN LIFE SCIENCES LTD FENOPROFEN CALCIUM USP
### A II 4/30/2007 TEVA PHARMACEUTICAL INDUSTRIES ATOMOXETINE HYDROCHLORIDE
LTD
### A II 4/30/2007 CHEMWERTH INC ETOMIDATE USP NON STERILE BULK DRUG
SUBSTANCE
### A II 4/30/2007 ZHEJIANG BETTER PHARMACEUTICALS CLARITHROMYCIN USP
CO LTD
### A II 5/1/2007 AARTI INDUSTRIES LTD BICALUTAMIDE
### I IV 5/3/2007 DO COOP TECHNOLOGIES LTD NEOWATER
### I II 5/1/2007 PCAS MIFEPRISTONE
### I IV 5/3/2007 FONA INTERNATIONAL INC 884.114 N-C NAT & ART ORANGE FLAVOR
### I IV 5/3/2007 FONA INTERNATIONAL INC 862.378 NATURAL LEMON FLAVOR WONF
### A IV 5/3/2007 FONA INTERNATIONAL INC 895.032 N-C ART PINEAPPLE FLAVOR
### I IV 5/3/2007 FONA INTERNATIONAL INC 825.527 N-C CHERRY FLAVOR ARTIFICIAL
### A II 5/3/2007 CADILA PHARMACEUTICALS LTD LOSARTAN POTASSIUM USP
### A II 5/7/2007 TARO PHARMACEUTICAL INDUSTRIES PREDNICARBATE USP MICRONIZED
LTD
20511 I II 5/7/2007 DR REDDYS LABORATORIES LTD FOSPHENYTOIN SODIUM
### I II 5/2/2007 BAYER PHARMA AG MS-275 FILM-COATED TABLETS
### A II 5/2/2007 BAYER AG MS-275
### I II 5/8/2007 OLON SPA FAMCYCLOVIR
### A II 5/8/2007 OLON USA INC ABACAVIR SULFATE
### I II 5/3/2007 ZHEJIANG JIUZHOU PHARMACEUTICAL OXCARBAZEPINE
CO LTD
### A II 5/9/2007 ZHUHAI UNITED LABORATORIES CO LTD AMOXICILLIN TRIHYDRATE USP
Page 652
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 5/8/2007 ZHEJIANG HUAHAI PHARMACEUTICAL RISPERIDONE USP
CO LTD
### A III 4/17/2007 ALUCAN ENTEC SAU PACKAGING MATERIAL
### A II 5/9/2007 HETERO LABS LTD HYDRALAZINE HYDROCHLORIDE
### I II 5/10/2007 DR REDDYS LABORATORIES LTD FINASTERIDE (FORM I)
### I II 5/8/2007 DELMAR CHEMICALS INC LEVODOPA METHYL ESTER HYDROCHLORIDE
### I III 5/8/2007 HEINKE TECHNOLOGY INC POWDER DISPENSING PRE-FILLED VAGINAL
APPLICATOR
### A II 5/10/2007 TAIZHOU HISOUND PHARMACEUTICAL CHOLECALCIFEROL CONCENTRATE (POWDER
CO LTD FORM) DRUG SUBSTANCE
### A II 5/11/2007 APOTEX PHARMACHEM INC IBANDRONATE SODIUM
### A IV 5/11/2007 COREL PHARMACHEM KYRON POLACRILLIN POTASSIUM
### A IV 5/11/2007 COREL PHARMACHEM ACRYSOL POLYOXYL 40 HYDROGENATED
CASTOR OIL
### I II 5/11/2007 USV LTD FLUVASTATIN SODIUM USP
### A II 5/10/2007 ST GOBAIN PERFORMANCE PLASTICS PHARMAFLOUR FEP BIOCOMPATIBLE TUBING
CORP
### A III 5/9/2007 3M DRUG DELIVERY SYSTEMS 3M COTRAN 9766
### I III 5/9/2007 3M DRUG DELIVERY SYSTEMS INVESTIGATIONS W/SWINE FED A COMBINATION
OF TYLOSIN-STREPTOMYCIN (VET)
Page 653
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 5/23/2007 ZAKLADY FARMACEUTYCZNE LAMOTRIGINE
POLPHARMA SA
### I II 5/18/2007 SIGMA ALDRICH MANUFACTURING LLC STEMLINE NEURAL STEM CELL EXPANSION
MEDIUM
### I II 5/18/2007 SIGMA ALDRICH MANUFACTURING LLC CHO KIT 2 IRON CHELATOR SOLUTION
### I II 5/18/2007 SIGMA ALDRICH MANUFACTURING LLC CHO MEDIUM MODIFICATION 21
### A II 5/21/2007 SUN PHARMACEUTICAL INDUSTRIES ATOMOXETINE HYDROCHLORIDE USP
LTD
### A III 4/18/2007 INEOS SERVICES BELGIUM NV INEOS POLYPROPYLENE GRADE 101-SA09
### A III 4/18/2007 INEOS SERVICES BELGIUM NV INEOS POLYPROPYLENE GRADE 194-NA25
### I V 5/22/2007 ASEPTIC TECHNOLOGIES SA PHARMACEUTICAL FILLING FACILITY FOR
FILLING STERILE INJECTABLE DEVELOPMENT
SAMPLES AND CLINICAL SUPPLIES AT LES
ISNES BELGIUM
### A II 5/23/2007 SUMITOMO DAINIPPON PHARMA CO LTD DROXIDOPA
### A II 5/23/2007 AARTI INDUSTRIES LTD LEVALBUTEROL HCL
### I III 5/17/2007 SEASONS POLYMERS PVT LTD PLASTIC BOTTLES/CONTAINERS, NOZZLES,
PILFER PROOF/TAMPER EVIDENT CAPS,
MEASURING CUPS, CHILD RESISTANT CAPS,
CLOSURES
### A II 5/18/2007 OLON SPA ATAZANAVIR SULFATE
### I II 5/25/2007 RANBAXY LABORATORIES LTD EFAVIRENZ
### I II 6/25/2007 ALKERMES GAINESVILLE LLC ELND-005
### A II 5/29/2007 FRESENIUS KABI AUSTRIA GMBH LACTULOSE CONCENTRATE USP
### I II 5/30/2007 SIEGFRIED LTD BENZPHETAMINE HYDROCHLORIDE
### I II 5/31/2007 UNIMARK REMEDIES LTD MONTELUKAST SODIUM
### A II 5/15/2007 ZHEJIANG CHIRAL MEDICINE METHYLDOPA
CHEMICALS CO LTD
### A II 5/29/2007 ACTAVIS GROUP PTC EHF LETROZOLE USP NON-STERILE BULK DRUG
SUBSTANCE
### I II 5/29/2007 ALDRICH CHEMICAL CO ISOTEC POTASSIUM PALMITATE -1,2,3,4-(13)C4
FACILITY
### A IV 5/10/2007 MOLKEREI MEGGLE WASSERBURG STARLAC®
GMBH AND CO KG
### A II 6/1/2007 JOHNSON MATTHEY PHARMACEUTICAL FLUVOXAMINE MALEATE (SVB)
MATERIALS
### A II 5/28/2007 MEGAFINE PHARMA P LTD MIRTAZAPINE ANHYDROUS USP (NON-STERILE
DRUG SUBSTANCE)
### I II 6/1/2007 TEVA PHARMACEUTICAL INDUSTRIES TELMISARTAN
LTD
### A II 4/10/2007 WANBURY LTD DIPHENHYDRAMINE HYDROCHLORIDE
### A II 5/29/2007 WANBURY LTD METFORMIN SR GRADE 70%
### A II 5/31/2007 SUN PHARMACEUTICAL INDUSTRIES ZOLEDRONIC ACID MONOHYDRATE
LTD
### A II 5/25/2007 GLENMARK PHARMACEUTICALS LTD TELMISARTAN USP
Page 654
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 7/4/2006 RENOLIT NEDERLAND BV RENOLIT SOLMED SPECIALTY PP/PVC-BASED
MULTILAYER TUBING
### A II 6/7/2007 HETERO DRUGS LTD ALFUZOSIN HYDROCHLORIDE
### I II 5/31/2007 BOCA PHARMACAL LLC GLYCOPYRROLATE USP
### I II 6/11/2007 CADILA HEALTHCARE LTD CSA SALT OF CLOPIDOGREL
### A II 6/7/2007 MSN PHARMACHEM PRIVATE LTD MONTELUKAST SODIUM USP [ROUTE CODE -
MT"]
### A II 6/6/2007 ZAKLADY FARMACEUTYCZNE TOPIRAMATE
POLPHARMA SA
### A II 6/7/2007 HALCYON LABS PRIVATE LTD BETAMETHASONE DIPROPIONATE USP
### I II 6/5/2007 WANBURY LTD PANTOPRAZOLE SODIUM SESQUIHYDRATE
### A II 4/30/2007 HUNAN JIUDIAN PHARMACEUTICAL CO DIRITHROMYCIN
LTD
### A IV 6/7/2007 SPECGX LLC MAGNESIUM STEARATE (CODES 2257 & 5712)
### A II 6/4/2007 ZHEJIANG HUAHAI PHARMACEUTICAL CITALOPRAM HYDROBROMIDE USP
CO LTD
### I II 6/5/2007 ROCHE DIAGNOSTICS GMBH CARVEDILOL
### A IV 6/4/2007 SHING LIH FANG ENTERPRISE CO LTD EMPTY GELATIN CAPSULE
### I III 4/26/2007 PRETIUM PACKAGING PLASTIC PACKAGING MATERIAL
### A II 5/23/2007 SYMRISE INC NEO HELIOPAN OS
### A II 6/11/2007 HETERO DRUGS LTD OLANZAPINE (FORM-1)
### A II 6/12/2007 GLENMARK PHARMACEUTICALS LTD ROSUVASTATIN CALCIUM
### A II 6/12/2007 GLENMARK PHARMACEUTICALS LTD ROPINIROLE HYDROCHLORIDE USP
### A III 6/6/2007 NEMERA NEUENBURG GMBH DUAL STRIP DRY POWDER INHALER
### A II 6/8/2007 APOTEX PHARMACHEM INC ALFUZOSIN HYDROCHLORIDE USP
### A II 6/12/2007 AMRI RENSSELAER INC DRONABINOL IN SESAME OIL DRUG SUBSTANCE
Page 656
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 5/20/2007 JIANGSU NHWA PHARMACEUTICAL CO GABAPENTIN
LTD
### I II 6/26/2007 SUN PHARMACEUTICAL INDUSTRIES METOPROLOL SUCCINATE USP
LTD
### A III 6/28/2007 POLYONE CORP CC10042428WE TP GREEN
### A III 6/28/2007 POLYONE CORP CC00018501WE
### A II 6/29/2007 FERMION OY IRINOTECAN HYDROCHLORIDE
### I II 7/6/2007 CADILA HEALTHCARE LTD CLOPIDOGREL BISULFATE USP (FORM-I)
### I II 6/25/2007 ALEMBIC PHARMACEUTICALS LTD ALENDRONATE SODIUM USP
### A III 6/21/2007 3M DRUG DELIVERY SYSTEMS 3M PACKAGING FILM PF200CD
### A III 6/21/2007 3M DRUG DELIVERY SYSTEMS 3M PACKAGING FILM LF400M
### A II 7/3/2007 FINE CHEMICALS CORP PTY LTD ROPIVACAINE HYDROCHLORIDE
### A II 7/2/2007 SHANDONG NEW TIME MYCOPHENOLATE MOFETIL
PHARMACEUTICAL CO LTD
### I II 7/18/2007 JIANGSU JIWA RINTECH RISPERIDONE EP, NON-STERILE DRUG
PHARMACEUTICAL CO LTD SUBSTANCE
### I III 7/6/2007 DYNEON GMBH AND CO KG TFR 1105 PTFE
### A II 6/20/2007 ZHEJIANG HISUN PHARMACEUTICAL CO DACTINOMYCIN USP
LTD
### A II 7/9/2007 HETERO DRUGS LTD VALACYCLOVIR HYDROCHLORIDE
MONOHYDRATE
### A II 7/6/2007 FRESENIUS KABI ONCOLOGY LTD ANASTROZOLE
### I II 8/2/2007 CHEMWERTH INC KETOTIFEN HYDROGEN FUMARATE
### A II 7/9/2007 CHEMPACIFIC CORP CHP010 DRUG SUBSTANCE
### I IV 6/27/2007 CRODA INC SUPER REFINED POLYETHYLENE GLYCOL 300
NF
### I II 6/30/2007 CHONGQING BIOCARE DOXAZOSIN MESYLATE USP
PHARMACEUTICAL CO LTD
### A II 7/9/2007 JIANGSU HENGRUI MEDICINE CO LTD OXALIPLATIN USP
### A III 6/18/2007 BERRY GLOBAL GPWN60 HS
### A III 7/2/2007 NAMICOS CORP CLEANING OF GLASS VIALS AND OTHER
CONTAINER CLOSURE SYSTEMS FOR
PACKAGING DRUG PRODUCTS
### A IV 6/19/2007 ACG METALCRAFTS PRIVATE LTD EXCIPIENT MARKING SOLUTION
### A II 7/11/2007 MOREPEN LABORATORIES LTD LORATADINE (PROCESS 2) U.S.P.
### A III 6/18/2007 BERRY GLOBAL BFN60
### A II 7/12/2007 TEVA PHARMACEUTICAL INDUSTRIES ROSUVASTATIN CALCIUM (BULK)
LTD
### I II 7/6/2007 USV LTD ATOVAQUONE USP
### A III 6/13/2007 WIPAK OY APET 500
### A II 7/13/2007 HARMAN FINOCHEM LTD MEPROBAMATE USP
### A II 7/12/2007 NATCO PHARMA LTD ONDANSETRON HYDROCHLORIDE (INJECTABLE
GRADE)
### A II 7/11/2007 INDUSTRIALE CHIMICA SRL DROSPIRENONE USP
Page 657
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 7/2/2007 ZHEJIANG NEO DANKONG ROSUVASTATIN CALCIUM INTERMEDIATE (RJS3)
PHARMACEUTICAL CO LTD
### A II 7/13/2007 NATCO PHARMA LTD GRANISETRON HYDROCHLORIDE (INJECTABLE
GRADE)
### I II 11/7/2007 CIPLA LTD MYCOPHENOLATE MOFETIL BP/PH. EUR.
### A II 8/16/2007 CIPLA LTD TRIMETAZIDINE DIHYDROCHLORIDE BP/PH.EUR.
Page 665
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 10/5/2007 SAI LIFE SCIENCES LTD LATANOPROST, NON-STERILE BULK DRUG
SUBSTANCE
### A III 9/19/2007 YEONHAP GLASS CO LTD CLEAR AMPOULE & VIAL
### I II 10/1/2007 BIO 2 INC BIOCATALYST SUBSTANCE
### I II 11/21/2007 SALIENT PHARMACEUTICALS INC HYDRATED CALCIUM ALUMINOSILICATE
UNIFORM PARTICLE SIZE NON-SWELLING (HCAS
UPSN)
### I II 10/22/2007 IPCA LABORATORIES LTD FLUCONAZOLE USP
### A II 10/18/2007 IPCA LABORATORIES LTD CARVEDILOL USP
### I II 10/8/2007 CHEMWERTH INC IMIQUIMOD, NON-STERILE BULK DRUG
SUBSTANCE
### A II 10/5/2007 UNIMARK REMEDIES LTD TOPIRAMATE USP
### I II 10/11/2007 SALTIGO GMBH N-BENZYLHYDRAZINE MSA SALT DRUG
SUBSTANCE INTERMEDIATE
### I III 10/1/2007 T AND S BLOWMOULDING INC PRECLINICAL STUDIES ON IBOGAINE
### A II 10/8/2007 PQ SILICAS UK LTD SORBOSIL(R) AC43, SYNTHETIC AMORPHOUS
SILICA PRECIPITATE
### I IV 10/9/2007 SILESIA FLAVORS INC N&A CITRUS FRUIT FREEZE- FLAVOR
1100609500
### A II 8/4/2007 ZHEJIANG HISOAR PHARMACEUTICAL CLINDAMYCIN PHOSPHATE
CO LTD
### A II 10/17/2007 JUBILANT GENERICS LTD OXCARBAZEPINE CO-PRECIPITATE
### I II 9/24/2007 ZHEJIANG HUAHAI PHARMACEUTICAL VALSARTAN DRUG SUBSTANCE
CO LTD
### A II 10/3/2007 SUN PHARMACEUTICAL INDUSTRIES MEMANTINE HYDROCHLORIDE USP
LTD
### I II 10/12/2007 RANBAXY LABORATORIES LTD MEMANTINE HYDROCHLORIDE
### A II 10/12/2007 SCINOPHARM TAIWAN LTD DOCETAXEL TRIHYDRATE USP
### A III 9/25/2007 AARDEE EXTRUSIONS INDIA PV LTD ALUMINIUM COLLAPSIBLE TUBES FOR FILLING &
PACKING OF PHARMACEUTICAL OINTMENTS,
CREAMS AND GELS
### I II 10/9/2007 WORLD JIANGSU INDUSTRY CO LTD BACITRACIN USP, NON-STERILE DRUG
SUBSTANCE
### I II 10/15/2007 DIVIS LABORATORIES LTD TRIPEPTIDE, DRUG INTERMEDIATE
### I II 10/15/2007 EURAND INC EUR-1057 EXTENDED-RELEASE DOSAGE
FORMS
### I II 10/12/2007 ZHEJIANG CANDORLY DIDANOSINE EUR.PH NON-STERILE DRUG
PHARMACEUTICAL CO LTD SUBSTANCE
### I II 10/15/2007 EXCELLA GMBH MYCOPHENOLATE MOFETIL
### I II 10/17/2007 CRYSTAL PHARMA SAU MIFEPRISTONE, MICRONIZED
### A II 10/15/2007 CORDEN PHARMA CHENOVE CHOLINE FENOFIBRATE DRUG SUBSTANCE
### I II 9/3/2007 PT KIMIA FARMA PERSERO TBK QUININE SULFATE
### I II 9/3/2007 PT KIMIA FARMA PERSERO TBK QUININE HYDROCHLORIDE
### I II 10/18/2007 SANDOZ INDUSTRIAL PRODUCTS SPA PRAVASTATIN T-BA, DRUG SUBSTANCE
INTERMEDIATE
Page 666
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 10/10/2007 ABELEI INC 127A55 N&A CHERRY FLAVOR
### A IV 10/10/2007 ABELEI INC 134A46 N&A CINNAMON FLAVOR
### A IV 10/11/2007 MANE INC F94249 PEPPERMINT FLAVOR
### I II 10/18/2007 SANDOZ GMBH STERILE OXACILLIN SODIUM, BUFFERED
### I II 10/15/2007 POLYPLUS TRANSFECTION SA IN VIVO-JETPEI(TM), NON-STERILE BULK DRUG
SUBSTANCE
### A II 10/18/2007 DISHMAN CARBOGEN AMCIS LTD BUPIVACAINE HYDROCHLORIDE
### A IV 10/11/2007 BASF SE LUDIFLASH®
### A II 10/22/2007 POLYMED THERAPEUTICS INC DOCETAXEL ANHYDROUS, NON-STERILE BULK
DRUG SUBSTANCE
### A II 10/22/2007 ORCHID PHARMA LTD TADALAFIL
### A II 10/22/2007 ORCHID PHARMA LTD VENLAFAXINE HYDROCHLORIDE
### I III 10/19/2007 RELIANCE INDUSTRIES LTD POLYVINYL CHLORIDE (PVC) RAW MATERIAL
GRADE REON 60GER01
### I III 10/19/2007 RELIANCE INDUSTRIES LTD POLYVINYL CHLORIDE (PVC) RAW MATERIAL
GRADE REON 57GER01
### I II 11/7/2007 CIPLA LTD LOSARTAN POTASSIUM USP
### I II 12/13/2007 CIPLA LTD MOMETASONE FUROATE MONOHYDRATE
### A II 10/24/2007 TRIFARMA SPA FOSPHENYTOIN SODIUM
### A II 10/25/2007 NANYANG PUKANG PHARMACEUTICAL CLINDAMYCIN HYDROCHLORIDE
CO LTD
### A III 9/25/2007 JITSAN ENTERPRISES PLASTIC BOTTLE & CONTAINERS, PLUG,
NOZZLE & DROPPERS, PILFER PROOF CAP &
CHILD RESISTANCE CAP, MEASURE CUP &
SPOONS, APPLICATORS & PESSARI
APPLICATORS
### I II 10/25/2007 HEBEI HUARONG PHARMACEUTICAL CO CYANOCOBALAMIN
LTD
### A III 9/27/2007 ROCHLING MEDICAL NEUHAUS GMBH ROUND TABLET JAR LINE WITH 2-PART TAMPER-
AND CO KG EVIDENT CLOSURE, CHILD-RESISTANT, SENIOR-
FRIENDLY WITH AND WITHOUT DRYING AGENT
Page 674
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/28/2007 ZHEJIANG SUPOR PHARMACEUTICALS BUPROPION HYDROCHLORIDE USP
CO LTD
### A II 12/31/2007 AUROBINDO PHARMA LTD OMEPRAZOLE USP (NON-STERILE DRUG
SUBSTANCE)
### A II 1/17/2008 H LUNDBECK AS LU AA21004 HYDROBROMIDE
### A IV 1/4/2008 COREL PHARMACHEM Colorcoat, Ready to Use Coating Material
### A III 1/7/2008 JAPAN VILENE CO LTD MEDICAL BACKING NON WOVEN PRODUCTS
### I II 1/11/2008 APOTEX PHARMACHEM INDIA PVT LTD MYCOPHENOLATE MOFETIL USP
### I II 1/11/2008 SIGMA ALDRICH MANUFACTURING LLC TrypZean Bovine, Recombinant Expressed in Corn
### A II 1/11/2008 GLENMARK PHARMACEUTICALS LTD TERBINAFINE HYDROCHLORIDE USP
### A II 1/10/2008 LUPIN LTD LAMIVUDINE USP
### I II 1/16/2008 DSM ANTI INFECTIVES BV Mycophenolic Acid Triethylamine Salt
### I II 1/16/2008 DSM ANTI INFECTIVES BV MYCOPHENOLATE MOFETIL
### A II 1/15/2008 EVERLIGHT CHEMICAL INDUSTRIAL Alprostadil
CORP
### I II 1/15/2008 APICORE LLC Protriptyline Hydrochloride
### I II 1/16/2008 TORRENT PHARMACEUTICALS LTD CLOPIDOGREL BISULPHATE FORM II
### I III 1/10/2008 AMPACET CORP Ampacet 181908 Amber Polyethylene Masterbatch
### A II 1/11/2008 CHEMWERTH INC MELPHALON USP
### A II 1/31/2008 ORCHID PHARMA LTD GEMIFLOXACIN MESYLATE (NON-STERILE BULK
API)
### A II 1/15/2008 INDOCO REMEDIES LTD ALLOPURINOL USP
### A III 2/6/2008 TRICORBRAUN MAGNESIUM SULFATE DESICCANT
### I II 2/18/2008 IPCA LABORATORIES LTD CLOPIDOGREL BISULFATE (FORM 1) USP
(PROCESS-II)
### I II 1/8/2008 WORLD JIANGSU INDUSTRY CO LTD Fusidic Acid & Sodium Fusidate (Non-Sterile Drug
Substance)
### I II 1/9/2008 WORLD JIANGSU INDUSTRY CO LTD Polymyxin B Sulfate USP (Non-Sterile Drug
Substance)
### A II 12/19/2007 ASIAN HERBEX LTD CURCUMIN
### A II 1/10/2008 SAI LIFE SCIENCES LTD BENZINDENE TRIOL INTERMEDIATE
### A II 1/14/2008 PROCOS SPA FELBAMATE
### A II 1/10/2008 BENE PHARMACHEM GMBH AND CO KG PENTOSAN POLYSULFATE SODIUM (PPS), NON-
STERILE BULK DRUG SUBSTANCE
### I II 12/6/2007 ZHEJIANG HISOAR PHARMACEUTICAL Tramadol Hydrochloride
CO LTD
### I II 1/22/2008 SMS PHARMACEUTICALS LTD Sildenafil Citrate
### A II 1/15/2008 RA CHEM PHARMA LTD METAXALONE USP
### A III 1/18/2008 INEOS SERVICES BELGIUM NV LOW DENSITY POLYETHYLENE GRADES ELTEX
MED¨ PH22D630, PH23T630, PH27D630 AND
PH30D630
### A III 1/22/2008 CODING PRODUCTS TTR-79160
### A II 2/7/2008 IPCA LABORATORIES LTD METOPROLOL TARTRATE USP (PROCESS III)
### A II 1/16/2008 ALP PHARM BEIJING CO LTD PARICALCITOL USP (NON-STERILE DRUG
SUBSTANCE)
Page 675
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 1/16/2008 CHANGZHOU RUIMING AMLODIPINE BESYLATE (NON-STERILE DRUG
PHARMACEUTICAL CO LTD SUBSTANCE)
### I II 1/20/2006 FINETECH PHARMACEUTICAL LTD TROVOPROST (TOS-00)
### A II 1/14/2008 YONEZAWA HAMARI CHEMICALS LTD POLAPREZINC
### I II 1/11/2008 RIZHAO TOP SCIENCE BIO TECH CO LTD CHONDROITIN SULFATE SODIUM
Page 677
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I IV 2/5/2008 MASTERTASTE INC DBA KERRY 700512 ARTIFICIAL CHERRY FLAVOR
INGREDIENTS AND FLAVOURS
### A II 2/5/2008 OLON SPA BENZPHETAMINE HYDROCHLORIDE
### A II 2/4/2008 HALCYON LABS PRIVATE LTD BETAMETHASONE VALERATE USP
### I III 1/30/2008 AMPACET CORP AMPACET 110313-C WHITE POLYETHYLENE
MASTERBATCH
### A II 2/7/2008 CALYX CHEMICALS AND ISONIAZID
PHARMACEUTICALS LTD
### A II 2/7/2008 CORDEN PHARMA BRUSSELS SA OMIGANAN PENTAHYDROCHLORIDE BULK
DRUG SUBSTANCE
### I II 2/1/2008 CHR HANSEN INC LACTOBACILLUS GG, LGG Grade PAb
### I II 2/6/2008 SIBRA PHARMACEUTICALS LTD AN ZIDOVUDINE USP
ARCH ENTERPRISE
### A II 2/7/2008 TAI HENG INDUSTRY CO LTD GLYCOPYRROLATE USP
### I II 2/11/2008 TEVA PHARMACEUTICALS INDUSTRIES RALOXIFENE HYDROCHLORIDE BULK DRUG
LTD SUBSTANCE
### I III 2/5/2008 AVON AMPOULES PVT LTD NEUTRAL GLASS AMPOULES AND TUBULAR
VIALS
### I II 1/31/2008 AUROBINDO PHARMA LTD CEFOXITIN SODIUM USP (STERILE BULK)
### A II 1/31/2008 TEVA PHARMACEUTICAL INDUSTRIES NORTRIPTYLINE HYDROCHLORIDE USP
LTD
### I II 2/7/2008 TEVA PHARMACEUTICAL INDUSTRIES ROPINIROLE HYDROCHLORIDE USP
LTD
### A II 2/12/2008 DR REDDYS LABORATORIES LTD DILUTED TACROLIMUS 20%
### I II 9/3/2007 GENESEN LABS LTD BICALUTAMIDE
### A II 2/12/2008 AARTI INDUSTRIES LTD MOMETASONE FUROATE
### I II 2/14/2008 SYMED LABS LTD CARBINOXAMINE MALEATE USP
### A II 2/12/2008 AARTI INDUSTRIES LTD QUETIAPINE FUMARATE USP
### I IV 2/14/2008 FONA INTERNATIONAL INC 895.096 NAT PINEAPPLE FLAVOR (WONF)
### I IV 2/14/2008 FONA INTERNATIONAL INC 889. 244 PEACH FLAVOR, NATURAL (WONF)
### I III 2/12/2008 CORMACK PACKAGING PTY LTD CORMACK TECR-TT (3-PIECE TAMPER EVIDENT
CHILD RESISTANCE CLOSURE FOR TAMPER TEL
NECK FINISH, SIZE 24 & 28MM)
### A III 2/13/2008 BPREX HEALTHCARE OFFRANVILLE SAS PP EYE-DROPPER RANGE
### I II 2/1/2008 SAFC BIOSCIENCES INC 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
### A II 2/26/2008 NIPPON PROTEIN CO LTD L-CYSTEINE HYDROCHLORIDE MONOHYDRATE
### I IV 2/20/2008 FONA INTERNATIONAL INC 894.132 PEPPERMINT FLAVOR (A NATURAL
FLAVOR)
### A III 2/22/2008 POLYONE CORP CC10031855BG, CC00041542BG, CC00039937BG,
CC00039936BG
### A II 2/27/2008 SPI PHARMA INC CALCIUM CARBONATE DC CS90 PRODUCTS
### I II 2/1/2008 SAFC BIOSCIENCES INC EX-CELL(TM) 301 COMPLETE MEDIUM W/ L-
GLUTAMINE, W/O SODIUM BICARBONATE
### I II 12/31/2007 CADILA PHARMACEUTICALS LTD IRBESARTAN (POLYMORPHIC FORM-A)
### I III 2/16/2008 CMT MATERIALS INC THERMOFORM PLUG ASSIST MATERIALS FOR
BLISTER PACKAGING
### I II 2/22/2008 PHARMATHEN INDUSTRIAL SA VENLAFAXINE HYDROCHLORIDE
### A II 2/18/2008 SPECGX LLC OXYMORPHONE BASE
### A II 2/25/2008 CHEMPACIFIC CORP CH011 (ACITRETIN) DRUG SUBSTANCE
### A II 5/21/2008 JUBILANT GENERICS LTD CANDESARTAN CILEXETIL USP
### I II 5/23/2008 JUBILANT ORGANOSYS LTD ESOMEPRAZOLE MAGNESIUM
### A II 8/1/2008 JUBILANT GENERICS LTD ATORVASTATIN CALCIUM (AMORPHOUS)
### A II 2/26/2008 APOTEX PHARMACHEM INDIA PVT LTD VENLAFAXINE HYDROCHLORIDE USP
### I III 2/12/2008 AMPACET CORP AMPACET PRODUCT 681726-PT AMBER PET
MASTERBATCH
Page 679
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 2/12/2008 AMPACET CORP AMPACET PRODUCT 681725-PT AMBER PET
MASTERBATCH
### A II 2/25/2008 DISHMAN NETHERLANDS BV CHOLECALCIFEROL
### I II 2/20/2008 CHEMI SPA DAPC (1,2-DIARACHIDOYL-SN-GLYCERO-3-
PHOSPHOCHOLINE)
### A II 2/26/2008 CHIROGATE INTERNATIONAL INC BIMATOPROST
### I III 3/3/2008 MITSUI CHEMICALS AMERICA INC ADMER CP-30A
### A II 2/21/2008 TOMITA PHARMACEUTICAL CO LTD DRIED ALUMINUM HYDROXIDE GEL
### I II 2/29/2008 ZHEJIANG JIUZHOU PHARMACEUTICAL DULOXETINE HYDROCHLORIDE
CO LTD
### A II 2/29/2008 PAR A TECHNOLOGIES PRIVATE LTD QUETIAPINE HEMIFUMARATE (NON-STERILE
BULK DRUG SUBSTANCE)
### A III 1/29/2008 REMY AND GEISER GMBH TUBULAR GLASS BOTTLES
### A III 2/15/2008 HILLSIDE PLASTICS INC HIGH DENSITY POLYETHYLENE CONTAINERS
### I II 3/3/2008 DR REDDYS LABORATORIES LTD ZOLEDRONIC ACID TRIHYDRATE
### I II 3/20/2008 ALKEM LABORATORIES LTD LAMOTRIGINE
### A II 3/3/2008 HEBEI YUXING BIO ENGINEERING CO CYANOCOBALAMIN
LTD
### A II 3/5/2008 HETERO DRUGS LTD CYCLOBENZAPRINE HYDROCHLORIDE
### A II 3/5/2008 APOTEX PHARMACHEM INDIA PVT LTD PERINDOPRIL TERT-BUTYLAMINE
### I II 3/5/2008 FDC LTD LEVALBUTEROL HYDROCHLORIDE
### A II 3/5/2008 HOVIONE PHARMASCIENCE LTD IVERMECTIN USP
### A II 3/6/2008 CALYX CHEMICALS AND CETIRIZINE DIHYDROCHLORIDE
PHARMACEUTICALS LTD
### I III 2/12/2008 AMPACET CORP 682084 PT AMBER PET
### I IV 3/3/2008 3M DRUG DELIVERY SYSTEMS DIV ACETYLOLIGOLACTIC ACID
HYDROXYETHYLUREA ESTER [OLA-72]
### A II 4/22/2008 FRESENIUS KABI ONCOLOGY LTD GEMCITABINE HYDROCHLORIDE
### A II 3/4/2008 SIEGFRIED EVIONNAZ SA TROSPIUM CHLORIDE
### I II 2/29/2008 JIANGXI SYNERGY PHARMACEUTICAL GABAPENTIN
CO LTD
### I II 2/28/2008 WATSON PHARMA PRIVATE LTD RAMIPRIL USP
### I IV 3/7/2008 ESSENTRA POROUS TECHNOLOGIES OPTIPOL(TM) PREPOLYMER AND MEDICAL
GRADE FLEXIBLE POLYURETHANE FOAM
### A II 2/20/2008 LIVZON NEW NORTH RIVER MYCOPHENOLIC ACID (NON STERILE BULK
PHARMACEUTICAL CO LTD FORM)
### A II 3/6/2008 MEDICHEM MANUFACTURING MALTA CINACALCET HYDROCHLORIDE (MED-200140/M )
LTD
### I IV 3/5/2008 KERRY BIOFUNCTIONAL INGREDIENTS Sheffcoat White
INC DBA KERRY BIO SCIENCE
### I IV 3/5/2008 KERRY BIOFUNCTIONAL INGREDIENTS Sheffcoat White ENT
INC DBA KERRY BIO SCIENCE
### I III 3/7/2008 POLIMERI EUROPA SPA FLEXIRENE MS 40 A
### I III 3/7/2008 POLIMERI EUROPA SPA FLEXIRENE MR 50 A
Page 680
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 3/8/2008 SUN PHARMACEUTICAL INDUSTRIES VALPROIC ACID USP
LTD
21411 I III 3/10/2008 STELLA KUNSTSTOFFTECHNIK GMBH DROP-DISPENSING BOTTLES 3 ML & 6 ML WITH
SZ14 NECK FINISH, AMBER AND SCREW CAPS
SZ14 BLUE WITH BRUSH
### I II 3/7/2008 FARMAK AS ESZOPICLONE
### A II 3/12/2008 BOEHRINGER INGELHEIM PHARMA PRAMIPEXOLE DIHYDROCHLORIDE
GMBH AND CO KG MONOHYDRATE
### A II 3/5/2008 SUN PHARMACEUTICAL INDUSTRIES LEVETIRACETAM USP
LTD
### A III 10/2/2007 CELGARD LLC CELGARD 2400 SEMI-PERMEABLE MEMBRANE
### I IV 3/5/2008 KERRY BIOFUNCTIONAL INGREDIENTS Sheffcoat Clear ENT
INC DBA KERRY BIO SCIENCE
### A II 3/11/2008 RA CHEM PHARMA LTD LEVOCETIRIZINE DIHYDROCHLORIDE USP
### A III 3/10/2008 SIBO G DOO CHILD RESISTANT CLOSURE CRP-045-F
### A III 3/10/2008 SIBO G DOO CHILD RESISTANT CLOSURE CRP-045-FE
### A III 3/10/2008 SIBO G DOO CONTAINER 60ML, V-045-060
### A III 3/10/2008 SIBO G DOO CONTAINER 120ML, V-055-120
### A II 3/14/2008 GLENMARK PHARMACEUTICALS LTD TAZAROTENE
### I II 3/7/2008 SHANGHAI YOUNGGREEN BIOTECH CO MYCOPHENOLATE MOFETIL (NON-STERILE A
LTD INGREDIENT)
### I II 3/10/2008 SHANDONG FANGXING TECHNOLOGY CARPROFEN (NON-STERILE DRUG SUBSTANCE)
DEVELOPMENT CO LTD
### I II 3/8/2008 WORLD JIANGSU INDUSTRY CO LTD RAPAMYCIN/SIROLIMUS (NON-STERILE, A
INGREDIENT)
### A II 3/17/2008 DR REDDYS LABORATORIES LTD LANSOPRAZOLE FORM-1
### I II 3/13/2008 MEDICHEM MANUFACTURING MALTA MED-201100/M
LTD
### A III 3/11/2008 MAK AMPOULES PVT LTD TUBULAR VIALS USP -1
### A III 3/11/2008 MAK AMPOULES PVT LTD GLASS AMPOULES USP -I
### A II 3/13/2008 FARMABIOS SPA FLUOCINONIDE, MICRONIZED BP/USP
### A IV 3/10/2008 UNGERER AND CO ARTIFICIAL BUBBLEGUM FLVP FC-1153
### A III 3/14/2008 NEMERA NEUENBURG GMBH I VIAL
### A III 3/14/2008 NEMERA NEUENBURG GMBH FLIP AWAY CAP
### I II 3/17/2008 DAEWOONG BIO INC URSODIOL USP (URSODEOXYCHOLIC ACID)
### A IV 3/5/2008 BIOGRUND GMBH AQUAPOLISH, PRE-MIXED EXCIPIENTS SYSTEM
FOR FILM COATING
### A III 4/7/2008 TRICORBRAUN DRY KEEP DESICCANT
### A II 3/11/2008 LUPIN LTD IMIPRAMINE HYDROCHLORIDE USP
### A II 3/14/2008 AMOLI ORGANICS PVT LTD VENLAFAXINE HYDROCHLORIDE USP
### A II 3/18/2008 APOTEX PHARMACHEM INC PAROXETINE HYDROCHLORIDE ANHYDROUS
USP
### I II 12/8/2007 YANCHENG XINYI PHARM AND CHEM CO EXEMESTANE (NON-STERILE, BULK FORM)
LTD
### A II 3/20/2008 SMS PHARMACEUTICALS LTD FAMOTIDINE USP
Page 681
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 3/18/2008 MEDICHEM MANUFACTURING MALTA MED-201950/E (VORICONAZOLE)
LTD
### A II 3/20/2008 DIPHARMA FRANCIS SRL IBUPROFEN LYSINE SALT
### I II 3/19/2008 SUMITOMO DAINIPPON PHARMA CO LTD RANIRESTAT (AS-3201)
### A II 3/19/2008 SUN PHARMACEUTICAL INDUSTRIES RISPERIDONE USP
LTD
### I II 3/21/2008 DR REDDYS LABORATORIES LTD RISEDRONATE SODIUM HEMIPENTAHYDRATE
### I II 5/9/2008 XOMA US LLC CELL LINE (SOURCE, HISTORY AND
GENERATION ) FOR SCH 900105 CONCENTRATE
FOR INJECTION
### I II 4/16/2008 IPCA LABORATORIES LTD ETODOLAC
### I III 3/21/2008 POLIMERI EUROPA SPA FLEXIRENE MT 40 A
### I IV 3/20/2008 MASTERTASTE INC DBA KERRY 709039 ARTIFICIAL BUBBLE GUM FLAVOR
INGREDIENTS AND FLAVOURS
### A III 3/3/2008 RAJESH PLASTICS PRIMARY PACKAGING MATERIAL
### A IV 3/6/2008 HEALTHCAPS INDIA LTD EMPTY HARD GELATIN CAPSULES
### A II 3/1/2008 ZHEJIANG HISOAR PHARMACEUTICAL METOPROLOL SUCCINATE
CO LTD
### A II 3/24/2008 IRVINE SCIENTIFIC SALES CO FMDF-9 (KIRIN)
### A II 3/24/2008 IRVINE SCIENTIFIC SALES CO INC KI NSM-15 (KIRIN)
### A II 3/24/2008 IRVINE SCIENTIFIC SALES CO KI NSM-16 (KIRIN)
### A II 3/24/2008 IRVINE SCIENTIFIC SALES CO FMDF-10 (KIRIN)
### A III 3/18/2008 COLORTECH INC 11629-09 WHITE POLYETHYLENE CONCENTRATE
Page 684
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 4/17/2008 VITALIFE LABORATORIES DIV ARCH LAMIVUDINE USP
PHARMALABS LTD
### I II 4/17/2008 SIBRA PHARMACEUTICALS LTD AN LAMIVUDINE USP
ARCH ENTERPRISE
### A IV 4/18/2008 SUMITOMO SEIKA CHEMICALS CO LTD POLYETHYLENE OXIDE (PEO): A NON-IONIC
WATER SOLUBLE THERMOPLASTIC RESIN
### A II 4/18/2008 LUPIN LTD FENOFIBRATE USP
### I II 4/21/2008 SMS PHARMACEUTICALS LTD LANSOPRAZOLE USP
### I II 4/14/2008 XIAN LIBANG PHARMACEUTICAL CO LTD IBUTILIDE FUMARATE, NON-STERILE BULK
DRUG
### A II 4/17/2008 MSN LABORATORIES PRIVATE LTD EZETIMIBE USP [ROUTE CODE - EB]
### I III 4/23/2008 VARI SPA KEMP HFA METERED DOSE AEROSOL VALVES
### A II 6/27/2008 PFIZER HEALTHCARE INDIA PVT LTD THN-CYCLIC (IMIPENEM INTERMEDIATE)
### A II 5/29/2008 CIPLA LTD OSELTAMIVIR PHOSPHATE USP
### I III 4/9/2008 VERRETUBEX AMPOULES, VIALS AND CARTRIDGES
### A II 4/15/2008 BOEHRINGER INGELHEIM PHARMA DIGOXIN 20 MICROMETER
GMBH AND CO KG
### I II 4/22/2008 MALLINCKRODT INC SODIUM SULFATE USP ANHYDROUS MILLED
POWDER
### A III 4/21/2008 BPREX HEALTHCARE OFFRANVILLE SAS 60 ML PILLJAR
### A III 4/15/2008 RUBY SURGICAL AND ALLIED ABSORBENT COTTON/PURIFIED COTTON
PRODUCTS PRIVATE LTD
### I II 1/15/2008 YANCHENG XINYI PHARM AND CHEM CO MEDROXYPROGESTERONE ACETATE (NON-
LTD STERILE BULK FORM)
### A III 3/18/2008 CHONGQING ZHENGCHUAN GLASS CO CONTAINERS FOR PARENTERAL PREPARATIONS
LTD MADE OF BOROSILICATE GLASS ( I) TUBING
### A III 3/18/2008 CHONGQING ZHENGCHUAN GLASS CO CONTAINERS FOR PARENTERAL PREPARATIONS
LTD OF LOW-BOROSILICATE GLASS ( I) TUBING
Page 688
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 6/4/2008 JOHNSON MATTHEY PHARMACEUTICAL OXYMORPHONE HCL, USP
MATERIALS
### A II 7/25/2008 IPCA LABORATORIES LTD ALLOPURINOL USP
### A II 9/20/2008 IPCA LABORATORIES LTD FENOFIBRATE USP
### I II 10/20/2008 IPCA LABORATORIES LTD CILOSTAZOL USP
### A II 7/1/2008 IPCA LABORATORIES LTD TRAMADOL HYDROCHLORIDE USP
### A II 8/12/2008 IPCA LABORATORIES LTD WARFARIN SODIUM CLATHRATE USP
### A II 6/10/2008 KYOWA PHARMA CHEMICAL CO LTD BIMATOPROST DRUG SUBSTANCE
### A II 6/5/2008 TORRENT PHARMACEUTICALS LTD RALOXIFENE HYDROCHLORIDE
### I III 6/5/2008 ROHM AND HAAS CO ADCOTE 548E AND COREACTANT F
### I IV 6/6/2008 MASTERTASTE INC DBA KERRY 700355 NATURAL AND ARTIFICIAL ORANGE
INGREDIENTS AND FLAVOURS FLAVOR
### A IV 6/6/2008 CAPSUGEL INC EMPTY HARD CAPSULES FROM
HYDROXYPROPYLMETHYLCELLULOSE
(HYPROMELLOSE)
### I II 5/4/2008 ZHEJIANG SUPOR PHARMACEUTICALS QUETIAPINE FUMARATE
CO LTD
### I II 6/11/2008 SIFAVITOR SRL KETOTIFEN
### A II 6/7/2008 AUROBINDO PHARMA LTD VALACYCLOVIR HYDROCHLORIDE USP (NON-
STERILE DRUG SUBSTANCE)
### A II 7/23/2008 PFIZER HEALTHCARE INDIA PVT LTD SODIUM BICARBONATE (STERILE)
### A II 6/27/2008 PFIZER HEALTHCARE INDIA PVT LTD MPEP (MEROPENEM INTERMEDIATE)
### I II 6/12/2008 CARDINAL HEALTH 414 LLC FLUOROMISONIDAZOLE F 18 INJECTION
### I II 6/7/2008 ERREGIERRE SPA CHENODEOXYCHOLIC ACID EP
### A II 5/28/2008 MSN LABORATORIES PRIVATE LTD KETOROLAC TROMETHAMINE USP
### A II 6/12/2008 PIRAMAL ENTERPRISES LTD AMIODARONE HYDROCHLORIDE
### A II 4/9/2008 SOHAN HEALTHCARE PVT LTD METFORMIN HYDROCHLORIDE USP
### A III 5/16/2008 AMPACET CORP 110017-A WHITE POLYETHYLENE MASTERBATCH
Page 689
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 7/31/2008 PFIZER HEALTHCARE INDIA PVT LTD MEROPENEM + SODIUM CARBONATE (STERILE
BULK)
### A II 7/31/2008 PFIZER HEALTHCARE INDIA PVT LTD MEROPENEM (STERILE)
21711 A II 6/3/2008 MYLAN LABORATORIES LTD SUMATRIPTAN SUCCINATE USP
### A II 5/28/2008 MYLAN LABORATORIES LTD PRAMIPEXOLE DIHYDROCHLORIDE USP
### A II 6/10/2008 SICHUAN XIELI PHARMACEUTICAL CO IRINOTECAN HCL
LTD
### A II 6/13/2008 CHEMSPEC API BIS (3, 5-DIBROMOSALICYL) FUMARATE (DBSF)
### A II 5/12/2008 TIANJIN TASLY SANTS ESZOPICLONE
PHARMACEUTICAL CO LTD
### A II 6/6/2008 AMRI RENSSELAER INC RACEPINEPHRINE HYDROCHLORIDE, USP
DRUG SUBSTANCE
### I II 6/6/2008 QILU PHARMACEUTICAL CO LTD TERBINAFINE HYDROCHLORIDE (NON STERILE,
API)
### I III 6/2/2008 RITE SYSTEMS INC WHITE, LQC-W2433-1
### I II 5/19/2008 HARIKA DRUGS PRIVATE LTD CHLORPHENIRAMINE TANNATE
### A II 6/20/2008 SOLARA A PHARMA SCIENCES LTD CYCLOSERINE USP
### A II 6/18/2008 ZHEJIANG SHENGHUA BIOK BIOLOGY PLEUROMUTILIN
CO LTD
### A II 6/10/2008 DELAVAU LLC CALCIUM CARBONATE/MAGNESIUM HYDROXIDE
GRANULATION
### A III 5/26/2008 NUOVA OMPI SRL UNIPERSONALE E-Z-FILL PRODUCTS
### A III 6/13/2008 EQUISTAR CHEMICALS LP A PRO-FAX ULTRA SC973
LYONDELLBASELL INDUSTRIES CO
### I II 3/26/2008 THERMAX LTD CHEMICAL DIV TULSION 345 (CALCIUM POLYSTYRENE
SULPHONATE BP)
### I II 3/17/2008 THERMAX LTD CHEMICAL DIV TULSION 412 CHL (CHOLESTYRAMINE RESIN
USP)
### A III 6/17/2008 RELIANCE INDUSTRIES LTD POLYPROPYLENE (PP), H200MA
### I IV 6/17/2008 KERRY INGREDIENTS AND FLAVOURS NATURAL/ARTIFICIAL BUBBLE GUM FLAVOR
0011638
### I IV 6/17/2008 KERRY INGREDIENTS AND FLAVOURS ARTIFICIAL COTTON CANDY FLAVOR 0011640
### I IV 6/17/2008 KERRY INGREDIENTS AND FLAVOURS NATURAL/ARTIFICIAL BUBBLE GUM FLAVOR
0011639
### I IV 6/17/2008 KERRY INGREDIENTS AND FLAVOURS NATURAL/ARTIFICIAL CHERRY BERRY FLAVOR
0014700
### A II 6/14/2008 CTX LIFE SCIENCES PVT LTD METOPROLOL SUCCINATE USP
### A II 6/27/2008 STERLING SPA DROSPIRENONE
### I IV 6/25/2008 CIBA CORP IRGASURF HL560
### A III 7/2/2008 SHRIJI POLYMERS INDIA LTD POLYPROPYLENE CLOSURES
### A II 6/26/2008 TORRENT PHARMACEUTICALS LTD RABEPRAZOLE SODIUM USP
### A V 6/26/2008 ACS DOBFAR SPA VIALE ADDETTA PLANT - SMART PAK PLANT
### I II 6/25/2008 AVANTI POLAR LIPIDS INC 1,2-DISTEAROYL-SN-GLYCERO-3-
PHOSPHOCHOLINE (DSPC)
### A II 6/25/2008 AVANTI POLAR LIPIDS INC DICETYL PHOSPHATE (770042)
Page 690
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 6/28/2008 MACLEODS PHARMACEUTICALS LTD INDOMETHACIN DRUG SUBSTANCE
### I II 6/24/2008 MALLINCKRODT INC COMPAP 90 (ACETAMINOPHEN USP 90%
ANHYDROUS BASIS)
### A V 6/27/2008 NOVARTIS PHARMACEUTICALS CORP DRUG SUBSTANCE MANUFACTURING AT
NOVARTIS BPO HUNINGUE
### I II 6/27/2008 WANBURY LTD LEVETIRACETAM
### A III 6/30/2008 BD MEDICAL - PHARMACEUTICAL BD UNIJECT PREFILLABLE INJECTION SYSTEM
SYSTEMS
### A II 6/30/2008 RELIABLE BIOPHARMACEUTICAL LLC CHLOROTHIAZIDE, USP
### I II 6/6/2008 LIANYUNGANG JARI PHARMACEUTICAL IRINOTECAN HYDROCHLORIDE TRIHYDRATE
CO LTD
### I II 6/27/2008 ZACH SYSTEM SPA LEVETIRACETAM
### A V 6/24/2008 COGNATE BIOSERVICES INC CONTRACT MANUFACTURING FACILITIES
### A II 7/1/2008 TEVA PHARMACEUTICAL INDUSTRIES PALONOSETRON HCL
LTD
### A II 6/27/2008 EDMOND PHARMA TULOBUTEROL BASE
### I II 7/18/2008 SUN PHARMACEUTICAL INDUSTRIES QUINAPRIL HYDROCHLORIDE USP
LTD
### A II 7/21/2008 SUN PHARMACEUTICAL INDUSTRIES DULOXETINE HYDROCHLORIDE USP
LTD
### I II 7/19/2008 SUN PHARMACEUTICAL INDUSTRIES ROSIGLITAZONE MALEATE ANHYDROUS
LTD
### I II 6/27/2008 ZHEJIANG HUAHAI PHARMACEUTICAL IRBESARTAN
CO LTD
### A II 6/23/2008 PHARMA MAR SA TRABECTEDIN
### A II 7/1/2008 CAMBREX CHARLES CITY INC NICOTINE RESINATE, 20%
### I II 6/5/2008 OLON SPA TAMOXIFEN CITRATE
### I II 7/1/2008 RPG LIFE SCIENCES LTD MERCAPTOPURINE USP
### A II 6/30/2008 ZHEJIANG HISUN PHARMACEUTICAL CO CAPREOMYCIN SULFATE CONCENTRATE
LTD
### A IV 6/30/2008 SYMRISE INC 992890 ARTIFICIAL GRAPE FLAVOR 605935
### A II 7/3/2008 SHANGHAI AJINOMOTO AMINO ACID CO L-LEUCINE
LTD
### A II 7/3/2008 ASPEN OSS BV NANDROLONE DECANOATE
### A II 9/30/2008 CIPLA LTD LAMIVUDINE USP (PROCESS 3)
### A II 9/30/2008 CIPLA LTD LAMIVUDINE USP (PROCESS 2)
### A II 6/26/2008 LIANYUNGANG RUNZHONG AMIFOSTINE
PHARMACEUTICAL CO LTD
### A III 6/1/2008 JAMNADAS INDUSTRIES ALUMINUM FLIP OFF SEALS
### A II 6/27/2008 AUROBINDO PHARMA LTD DULOXETINE HYDROCHLORIDE USP (NON-
STERILE DRUG SUBSTANCE)
### A II 7/2/2008 SIEGFRIED LTD FLUOXETINE HYDROCHLORIDE
### I II 6/18/2008 FIS FABBRICA ITALIANA SINTETICI SPA FIS1174
### A III 7/3/2008 BESPAK CONSORT MEDICAL PLC BESPAK BK851 GSK DOSE COUNTER
### I III 7/4/2008 RELIANCE INDUSTRIES LTD RELENE F46003
Page 691
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 7/4/2008 RELIANCE INDUSTRIES LTD RELENE F19010
### A II 7/3/2008 PKC PHARMACEUTICALS INC RESINIFERATOXIN
### A II 6/30/2008 DCS PHARMA AG FLUOROURACIL
### A II 7/8/2008 HOVIONE FARMACIENCIA SA 05ST03P
### I III 6/30/2008 MATRIX PACKAGING INC PACKAGING MATERIAL
### A II 6/27/2008 JOINT STOCK CO GRINDEKS OXYTOCIN, USP
### A III 7/1/2008 CHARTER NEX FILMS INC GRADE NXSLC70E
### A II 7/8/2008 VASUDHA PHARMA CHEM LTD CYCLOBENZAPRINE HCL USP
### A II 5/28/2008 ZHEJIANG HUAHAI PHARMACEUTICAL IRBESARTAN USP
CO LTD
### A II 7/8/2008 DR REDDYS LABORATORIES LTD RIVASTIGMINE HYDROGEN TARTRATE
(PROCESS II )
### I II 6/26/2008 ZHEJIANG SANHE PHARMACHEM CO MONOALDEHYDE (3-[2-(7-CHLORO-QUINOLIN-2-
LTD YL)-VINYL]-BENZALDEHYDE)
### A IV 6/25/2008 DUPONT NUTRITION USA INC AVICEL HFE MICROCRYSTALLINE CELLULOSE
AND MANNITOL
### A IV 7/11/2008 CAPSUGEL INC VCAPS/VCAPS PLUS
### A III 7/9/2008 TOYO INK CO LTD GRAVURE INK "LAMISTAR" SERIES
### A II 7/11/2008 NATCO PHARMA LTD ERLOTINIB HYDROCHLORIDE
### I II 6/18/2008 QILU ANTIBIOTICS PHARMACEUTICAL 7-AMINO CEPHALOSPORANIC ACID (7-ACA)
CO LTD
### A II 7/10/2008 NIPPON RIKA CO LTD L-TYROSINE DRUG SUBSTANCE
### A II 7/10/2008 NIPPON RIKA CO LTD ACETYLCYSTEINE DRUG SUBSTANCE
### A II 6/24/2008 INKE SA GRANISETRON BASE
### A II 7/11/2008 CRYSTAL PHARMA SAU PRAMIPEXOLE DIHYDROCHLORIDE
MONOHYDRATE
### A III 7/4/2008 RELIANCE INDUSTRIES LTD POLYPROPYLENE (PP), GRADE: REPOL H200MK
Page 692
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 7/17/2008 AVANTI POLAR LIPIDS INC 1,2-DIPALMITOYL-SN-GLYCERO-3-
PHOSPHOETHANOLAMINE-N-(BIOTINYL)
(SODIUM SALT)(16:0 BIOTINYL PE)(770285)
### I II 7/17/2008 HOVIONE FARMACIENCIA SA TAMSULOSIN HYDROCHLORIDE
### A II 7/15/2008 CSPC OUYI PHARMACEUTICAL CO LTDTRAMADOL HYDROCHLORIDE
### A II 7/28/2008 FIS FABBRICA ITALIANA SINTETICI SPA
THALIDOMIDE
### A II 7/14/2008 OLON SPA ACAMPROSATE CALCIUM
### I II 7/16/2008 CHEMWERTH INC TACROLIMUS, NON-STERILE, BULK DRUG
SUBSTANCE
### I II 6/18/2008 SHANDONG KEYUAN PHARMACEUTICAL DILUTED ISOSORBIDE MONONITRATE (DRUG
CO LTD SUBSTANCE, NON-STERILE)
### I IV 7/11/2008 MASON CHEMICAL CO MACAT LB
21811 A III 7/16/2008 RELIANCE INDUSTRIES LTD POLYETHYLENE (PE), GRADE: 22FA002
### A III 7/16/2008 RELIANCE INDUSTRIES LTD POLYETHYLENE (PE), GRADE: 24FS040
### A III 7/16/2008 RELIANCE INDUSTRIES LTD POLYETHYLENE (PE), GRADE: 1005FY20
### A III 7/16/2008 RELIANCE INDUSTRIES LTD POLYETHYLENE (PE), GRADE:16MA400
### I II 7/18/2008 SANOFI AVENTIS US LLC EPLIVANSERIN HEMIFUMARATE
### I II 7/18/2008 ORPEGEN PHARMA TLN-232 DRUG SUBSTANCE
### A IV 7/23/2008 PURAC BIOCHEM BV PURASORB POLYMERS
### I II 7/10/2008 HTI TECHNOLOGIES HYDROXYAPATITE COATINGS WITH PURE
TITANIUM BOND COAT
### A II 7/18/2008 APOTEX PHARMACHEM INC RISEDRONATE SODIUM HEMIPENTAHYDRATE
USP
### I II 7/17/2008 MALLINCKRODT INC THE 6-BETA-NALTREXOL HYDROCHLORIDE
PHARMACEUTICALS BUSINESS OF
COVIDIEN
### A II 7/23/2008 CAMBREX CHARLES CITY INC SUFENTANIL
### I II 7/24/2008 NEWCHEM SPA PREDNISOLONE SODIUM PHOSPHATE
### A III 7/9/2008 RENOLIT SENXING PHARMMED RUBBER STOPPER
CONSUMABLE BJ LTD
### A II 7/28/2008 SOLARA A PHARMA SCIENCES LTD VENLAFAXINE HYDROCHLORIDE
### I III 7/25/2008 POLIMERI EUROPA SPA FLEXIRENE MS 20
### I II 7/28/2008 MENADIONA SL QUETIAPINE FUMARATE
### A II 7/28/2008 TEVA PHARMACEUTICAL INDUSTRIES DULOXETINE HCL
LTD
### I II 7/10/2008 LAKE CHEMICALS PRIVATE LTD ALPRAZOLAM
### A III 7/22/2008 HYDRO ALUMINIUM ROLLED PRODUCTS HARP 506/1 AND 506/2 DRUG PACKAGING
GMBH MATERIALS
### A II 7/28/2008 ICROM SPA EPINASTINE HYDROCHLORIDE
### A III 7/28/2008 KB SEIREN LTD H20N
### A III 8/27/2008 KB SEIREN LTD H20N-TU22
### A II 7/30/2008 SIGNA SA DE CV DULOXETINE HYDROCHLORIDE USP
### A II 7/29/2008 PMC ISOCHEM NEFOPAM HYDROCHLORIDE
### A II 7/24/2008 BAXTER PHARMACEUTICAL SOLUTIONS 0.9% SODIUM CHLORIDE DILUENT, USP
LLC
Page 693
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 7/29/2008 MEDICHEM MANUFACTURING MALTA MED-200448/M
LTD
### A II 7/28/2008 ESTEVE QUIMICA SA LEVETIRACETAM INJECTABLE GRADE/NON-
STERILE
### I II 7/30/2008 RANBAXY LABORATORIES LTD DULOXETINE HYDROCHLORIDE DRUG
SUBSTANCE
### I II 5/30/2008 SYNTHESIA AS ERGOCALCIFEROL
### I III 6/27/2008 AMPACET CORP AMPACET 19258-A- BLACK COP MASTERBATCH
### A II 7/31/2008 CRYSTAL PHARMA SAU HYDROCORTISONE BUTYRATE, MICRONIZED
### I II 7/9/2008 ZHEJIANG ANGLIKANG CEFALEXIN MONOHYDRATE (NON-STERILE,
PHARMACEUTICAL CO LTD BULK FORM)
### I IV 7/23/2008 COGNIS GMBH MONOMULS 90-L 12
### A II 9/29/2008 H LUNDBECK AS LU AA24530 HYDROBROMIDE
### A II 7/30/2008 AUROBINDO PHARMA LTD VALSARTAN USP (NON-STERILE DRUG
SUBSTANCE)
### A IV 8/1/2008 SYMRISE AG FRUIT PUNCH FLAVOUR SD 204264
### A IV 8/1/2008 SYMRISE GBMH CO KG NATURAL PEPPERMINT FLAVOR 290017
### A II 7/30/2008 TAIYO NIPPON SANSO CORP WATER-18O
### A III 7/31/2008 SABIC PETROCHEMICALS BV SABIC LDPE PCG80
### I II 8/1/2008 TEVA PHARMACEUTICAL INDUSTRIES ATORVASTATIN CALCIUM
LTD
### A II 8/1/2008 TRIFARMA SPA EPINASTINE HYDROCHLORIDE
### A II 7/31/2008 ROLABO OUTSOURCING SL DOLASETRON MESYLATE
### A II 8/4/2008 GLENMARK PHARMACEUTICALS LTD ESZOPICLONE USP
### A IV 7/30/2008 NECTAR LIFESCIENCES LTD MENTHOL USP
### I III 7/24/2008 SHANDONG PHARMACEUTICAL GLASS BOROSILICATE GLASS (USP I) BARRELS FOR
CO LTD INJECTABLES FOR PREFILLED SYRINGES
### A III 7/24/2008 SHANDONG PHARMACEUTICAL GLASS BOROSILICATE GLASS (USP I) CYLINDERS FOR
CO LTD PEN-INJECTORS FOR MEDICAL USE
### I II 8/1/2008 MEDICHEM MANUFACTURING MALTA MED-201570/M
LTD
### A II 7/29/2008 BIOCON LTD ATORVASTATIN CALCIUM AMORPHOUS
### A II 8/5/2008 MYLAN LABORATORIES LTD SALMETEROL XINAFOATE USP
### A II 7/24/2008 CENTAUR PHARMACEUTICALS PRIVATE DIAZEPAM USP
LTD
### A II 7/25/2008 SAVIOR LIFETEC CORP MEROPENEM AND SODIUM CARBONATE
(STERILE BULK)
### A II 8/6/2008 SOLARA A PHARMA SCIENCES LTD METHOXSALEN USP
### A II 8/4/2008 EXCELLA GMBH AND CO KG BICALUTAMIDE MILLED Z
### I II 8/5/2008 IWAKI SEIYAKU CO LTD CETIRIZINE HYDROCHLORIDE
### I II 9/26/2008 TEVA PHARMACEUTICAL INDUSTRIES METOPROLOL TARTRATE USP
LTD
### A II 8/7/2008 AARTI INDUSTRIES LTD RANOLAZINE
### I III 7/23/2008 AMPACET CORP AMPACET 172954 LIME GREEN
POLYPROPYLENE MASTERBATCH
Page 694
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 7/5/2008 ISOCHEM BUFLOMEDIL HYDROCHLORIDE
### I II 8/8/2008 NOVARTIS PHARMACEUTICALS CORP SMT487 ACETATE (EDOTREOTIDE)
### A II 7/25/2008 KAKEN PHARMACEUTICAL CO LTD KP-103/B
### I IV 7/28/2008 DOW CORNING CORP SILASTIC 7-6840 BIOMEDICAL GRADE LIQUID
SILICONE RUBBER
### A III 7/30/2008 GERRESHEIMER PLASTICOS SAO BOTTLES
PAULO LTDA
### I IV 8/11/2008 FONA INTERNATIONAL INC 827.014 NAT CINNAMON FLAVOR (WONF)
### I III 7/21/2008 YONWOO CORP AS30-J/PP AND AS50-J/PP
### I III 7/21/2008 YONWOO CORP AS30/50-J/PP JAR
### I II 10/31/2008 ABBVIE INC NIACIN CORE TABLET INTERMEDIATE
### A II 8/12/2008 ALMATICA PHARMA INC NAPRELAN (NAPROXEN SODIUM) CONTROLLED-
RELEASE TABLETS, 375MG, 500MG, 750MG
### I II 8/14/2008 BASIC PHARMA LIFE SCIENCE PVT LTD CHLORHEXIDINE GLUCONATE
### A II 8/12/2008 CORAL DRUGS PVT LTD FLUTICASONE PROPIONATE
### A II 8/14/2008 FORMOSA LABORATORIES INC PARICALCITOL
### A III 8/1/2008 POLYCINE GMBH APP107 TUBE
### A IV 8/15/2008 HENKEL CORP DURO-TAK¨ 87-613A PRESSURE SENSITIVE
ADHESIVE
### A II 8/13/2008 APICORE US LLC ISOSULFAN BLUE
### I II 7/30/2008 POLYDRUG LABORATORIES PVT LTD METOPROLOL SUCCINATE
### A III 7/7/2008 INEOS STYROLUTION EUROPE GMBH LURAN® HD 20
### A II 8/14/2008 PHARMAZELL INDIA PRIVATE LTD L-CYSTINE
### A II 8/5/2008 FIS FABBRICA ITALIANA SINTETICI SPA NITROFURANTOIN MONOHYDRATE (CODE 1042)
Page 696
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 8/25/2008 HARBIN PHARMACEUTICAL GROUP CO 6 AMINOPENCILLANIC ACID
LTD GENERAL PHARMACEUTICAL
FACTORY
### A III 8/31/2008 FUJIMORI KOGYO CO LTD FILMBYNA
### A II 9/2/2008 AUROBINDO PHARMA LTD GALANTAMINE HYDROBROMIDE USP (NON-
STERILE DRUG SUBSTANCE)
### A II 9/5/2008 CADILA HEALTHCARE LTD CLONIDINE
### A II 9/26/2008 RA CHEM PHARMA LTD VANILLYLAMINE HYDROCHLORIDE
### A II 9/20/2008 ORCHID PHARMA LTD ARIPIPRAZOLE (NON-STERILE BULK API)
### A II 10/18/2008 ORCHID PHARMA LTD ROPINIROLE HYDROCHLORIDE (NON-STERILE
BULK API)
### A II 9/5/2008 BOEHRINGER INGELHEIM PHARMA TIOTROPIUM BROMIDE MONOHYDRATE
GMBH AND CO KG
### A V 9/2/2008 AZBIL NORTH AMERICA BIOVIGILANT DIV IMD-A 300
### I II 9/4/2008 POLYDRUG LABORATORIES PVT LTD METOPROLOL TARTRATE USP
### I II 9/1/2008 ALP PHARM BEIJING CO LTD STERILE FINISHED PRODUCTS AND STERILE
PROCESSING OPERATIONS LOCATED IN
CHARLOTTE, NC.
### A II 9/1/2008 ALP PHARM BEIJING CO LTD CALCIPOTRIENE (CALCIPOTRIOL)
### I II 9/8/2008 ZHEJIANG XIANJU JUNYE MIFEPRISTONE
PHARMACEUTICAL CO LTD
### I III 9/5/2008 BOEHRINGER INGELHEIM PHARMA PLASTIC CONTAINER FOR RESPIMAT(R)
GMBH AND CO KG
### A II 3/10/2008 RN LABORATORIES PVT LTD CHLORHEXIDINE GLUCONATE 20% SOLUTION
### I II 9/8/2008 RANBAXY LABORATORIES LTD OLANZAPINE DRUG SUBSTANCE
### I II 9/1/2008 SICHUAN SANCHINE SUNNYHOPE MELOXICAM USP (DRUG SUBSTANCE, NON-
PHARMACEUTICAL CO LTD STERILE)
### I II 9/1/2008 ALP PHARM BEIJING CO LTD ALPRAZOLAM USP (DRUG SUBSTANCE, NON-
STERILE)
### I II 9/1/2008 ALP PHARM BEIJING CO LTD DALTEPARIN SODIUM (DRUG SUBSTANCE, NON-
STERILE)
### I II 9/1/2008 ALP PHARM BEIJING CO LTD AMLODIPINE BESYLATE (DRUG SUBSTANCE,
NON-STERILE)
### A II 9/5/2008 FORMOSA LABORATORIES INC MYCOPHENOLIC ACID
### I II 9/5/2008 DK PHARMA CHEM PVT LTD HYDRALAZINE HYDROCHLORIDE USP
### I II 10/1/2008 CIPLA LTD TORSEMIDE USP
### I II 9/5/2008 PIERRE FABRE MEDICAMENT VINFLUNINE INJECTION
PRODUCTION AQUITAINE PHARM
INTERNATIONAL
### A III 9/5/2008 KUNSTSTOFFWERK KREMSMUNSTER PP28 CHILD RESISTANT TAMPER-EVIDENT
GMBH SCREW CAPS WITH FILLED DESICCANT-INSERT
### I III 8/29/2008 MONDI COATING ZELTWEG GMBH FLEXIBLE PACKAGING MATERIALS
### A II 9/5/2008 MYLAN LABORATORIES LTD LANTHANUM CARBONATE
### I II 8/15/2008 BACHEM AMERICAS INC COSYNTROPIN TFA SALT PEPTIDE
Page 697
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 8/26/2008 CADILA PHARMACEUTICALS LTD ATORVASTATIN CALCIUM
### A II 9/4/2008 ANQIU LUAN PHARMACEUTICAL CO LTD ACETAMINOPHEN DC 90 6
### I II 9/9/2008 CADILA PHARMACEUTICALS LTD NATEGLINIDE FORM B
### A II 9/5/2008 DISHMAN NETHERLANDS BV CALCIFEDIOL
### A II 9/10/2008 LAURUS LABS LTD EFAVIRENZ USP
### A III 9/5/2008 FORMOSA PLASTICS CORP USA FORMOLON 690F POLYVINYL CHLORIDE (PVC)
RESIN
### A II 12/3/2008 CIPLA LTD RANOLAZINE
### A II 3/26/2009 CIPLA LTD ATAZANAVIR SULPHATE
### I II 9/5/2008 NANJING LANYA CHEMICAL CO LTD MAGNESIUM LACTATE DIHYDRATE
### A II 9/11/2008 MYLAN LABORATORIES LTD EFAVIRENZ USP
### I II 9/12/2008 CALYX CHEMICALS AND VALPROIC ACID
PHARMACEUTICALS LTD
### A II 9/10/2008 LUPIN LTD FENOFIBRATE-SLS MIXTURE
### A II 9/11/2008 FARMABIOS SPA BECLOMETASONE DIPROPIONATE
MONOHYDRATE MICRONIZED
### A III 8/12/2008 ESS DEE ALUMINIUM LTD NON TOXIC FOOD/PHARMA GRADE ALU ALU
LAMINATE, NON TOXIC FOOD/PHARMA GRADE
CHILD RESISTANT (CR) FOIL, NON TOXIC
FOOD/PHARMA GRADE TROPICALISED
LAMINATE
### A II 12/30/2008 CHEMWERTH INC EPINASTINE HCL
### A II 10/6/2008 IPCA LABORATORIES LTD INDAPAMIDE USP
### A II 9/13/2008 DR REDDYS LABORATORIES LTD ESZOPICLONE
### A III 9/11/2008 NEMERA NEUENBURG GMBH MIRENA INSERTER
### I II 9/16/2008 SMS PHARMACEUTICALS LTD NICOTINE POLACRILEX USP
### I II 10/13/2008 TEVA PHARMACEUTICAL INDUSTRIES METOPROLOL SUCCINATE USP
LTD
### A II 9/17/2008 APOTEX PHARMACHEM INC OLANZAPINE USP
### A II 9/8/2008 CORDEN PHARMA BERGAMO SPA OLSALAZINE SODIUM
### A II 9/10/2008 QILU ANTIBIOTICS PHARMACEUTICAL STERILE CEFAZOLIN SODIUM BULK ANTIBIOTIC
CO LTD DRUG SUBSTANCE
### I II 9/17/2008 EMCURE PHARMACEUTICALS LTD SODIUM FERRIC GLUCONATE COMPLEX
### A II 9/16/2008 CSPC OUYI PHARMACEUTICAL CO LTD INDOMETHACIN
### I II 9/15/2008 VITALIFE LABORATORIES DIV ARCH ATORVASTATIN CALCIUM CRYSTALLINE
PHARMALABS LTD
### I II 1/29/2009 JUBILANT ORGANOSYS LTD ESOMEPRAZOLE SODIUM
### A II 12/5/2008 JUBILANT GENERICS LTD MECLIZINE HYDROCHLORIDE
### A II 11/10/2009 JUBILANT GENERICS LTD LANSOPRAZOLE USP
### A II 11/26/2008 JUBILANT GENERICS LTD GALANTAMINE HYDROBROMIDE
### A II 9/26/2008 JUBILANT GENERICS LTD PINAVERIUM BROMIDE
### A II 7/17/2008 AJINOMOTO DO BRASIL INDUSTRIA E L-ISOLEUCINE
COMERCIO DE ALIMENTOS LTDA
### A III 9/1/2008 ANSAPACK PRIVATE LTD PRINTED CARTONS AND PRINTED LABELS AND
LEAFLETS
Page 698
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 9/15/2008 NEWCHEM SPA MOMETASONE FUROATE MICRONIZED
### A II 9/16/2008 UNITED LABORATORIES CHENGDU CO 6-AMINO-PENICILLANIC ACID (6-APA)
LTD
### A V 9/19/2008 GE HEALTHCARE INC FASTLAB PET SYNTHESIZER
### A V 9/2/2008 AZBIL NORTH AMERICA BIOVIGILANT DIV IMD-A-350
### I III 9/16/2008 TEKNOR APEX CO MEDALIST MD-100 NATURAL
### I III 9/16/2008 TEKNOR APEX CO MEDALIST MD-105 NATURAL
### I III 9/16/2008 TEKNOR APEX CO MEDALIST MD-110 NATURAL
### I III 9/16/2008 TEKNOR APEX CO MEDALIST MD-115 NATURAL
### I III 9/16/2008 TEKNOR APEX CO MEDALIST MD-120 NATURAL
### I III 9/16/2008 TEKNOR APEX CO MEDALIST MD-125 NATURAL
### I III 9/16/2008 TEKNOR APEX CO MEDALIST MD-130 NATURAL
### I III 9/16/2008 TEKNOR APEX CO MEDALIST MD-135 NATURAL
### I III 9/16/2008 TEKNOR APEX CO MEDALIST MD-140 NATURAL
### I III 9/16/2008 TEKNOR APEX CO MEDALIST MD-145 NATURAL
### I III 9/16/2008 TEKNOR APEX CO MEDALIST MD-150 NATURAL
### I III 9/16/2008 TEKNOR APEX CO MEDALIST MD-155 NATURAL
### I III 9/16/2008 TEKNOR APEX CO MEDALIST MD-160 NATURAL
### I III 9/16/2008 TEKNOR APEX CO MEDALIST MD-165 NATURAL
22011 I III 9/16/2008 TEKNOR APEX CO MEDALIST MD-170 NATURAL
### I III 9/17/2008 TEKNOR APEX CO MEDALIST MD-175 NATURAL
### I III 9/17/2008 TEKNOR APEX CO MEDALIST MD-180 NATURAL
### I II 8/28/2008 JIANGSU ZW PHARMACEUTICALS CO CAPECITABINE
LTD
### A II 9/19/2008 JIANGSU HENGRUI MEDICINE CO LTD GABAPENTIN, USP, NON-STERILE, BULK DRUG
SUBSTANCE
### A V 9/19/2008 WEST PHARMACEUTICAL SERVICES INC DAIKYO CRYSTAL ZENITH RU SYRINGE SYSTEM
Page 703
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 10/27/2008 ALP PHARM BEIJING CO LTD EPO (RECOMBINANT HUMAN ERYTHROPOIETIN)
Page 707
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 12/11/2008 CLARIANT HEALTHCARE PACKAGING EQ-PAK SACHET
(FRANCE)
### A II 12/12/2008 CHEMO IBERICA SA TIANEPTINE SODIUM
### A II 12/11/2008 RA CHEM PHARMA LTD MECLIZINE HYDROCHLORIDE USP
### A II 12/10/2008 IND SWIFT LABORATORIES LTD ATORVASTATIN CALCIUM USP
22311 A II 12/15/2008 WAVELENGTH ENTERPRISES LTD GRANISETRON BASE
### I II 5/12/2009 CIPLA LTD DESLORATADINE FORM I: FORM II (89:11)
### I III 12/16/2008 HOSPIRA INC STANDARD MICROBIOLOGICAL METHODS FOR
CONTRACT MANUFACTURED DRUG PRODUCT
PACKAGED IN I GLASS BOTTLES
### A III 12/15/2008 AMPACET CORP 100977 UV POLYETHYLENE MASTERBATCH
### A IV 12/17/2008 SYMRISE INC 994791 ARTIFICIAL BURNT SUGAR FLAVOR
687817
### A III 12/16/2008 THE DOW CHEMICAL CO SOLUTION POLYETHYLENE PRODUCTS
### A II 12/15/2008 OSAKA SODA CO LTD DAISOGEL SP-C8 SERIES CHEMICALLY
MODIFIED SILICA GEL
### A II 12/17/2008 NOF CORP DIPALMITOYL PHOSPHATIDYLGLYCEROL,
SODIUM SALT (DPPG-NA)
### A II 12/18/2008 FARMABIOS SPA MOMETASONE FUROATE
### A II 12/1/2008 SAFC INC SGD-1269
### I II 12/17/2008 KRKA DD NOVO MESTO LANSOPRAZOLE A SUBSTANCE
### A II 12/16/2008 POLYPEPTIDE LABORATORIES INC PTH (1-34), HUMAN, ACETATE
### I II 12/17/2008 CADILA HEALTHCARE LTD ANASTROZOLE
### A II 12/19/2008 SCINOPHARM TAIWAN LTD DESMOPRESSIN ACETATE
### A II 12/9/2008 LUPIN LTD RIFAMYCIN O
### I III 12/15/2008 COLORMATRIX CORP LIQUID COLORANT FOR USE IN COLORING PET
### A II 12/17/2008 NECTAR LIFESCIENCES LTD CEFUROXIME AXETIL USP (CRYSTALLINE)
### I II 12/20/2008 FRESENIUS KABI AUSTRIA GMBH LACTULOSE SOLUTION USP
### I II 12/19/2008 CAMBREX CHARLES CITY INC DEXTROMETHORPHAN POLISTIREX
### A II 12/17/2008 LUPIN LTD PREGABALIN
### A II 12/5/2008 CSPC OUYI PHARMACEUTICAL CO LTD AZITHROMYCIN
### A II 12/18/2008 NINGXIA QIYUAN PHARMACEUTICAL CO ERYTHROMYCIN THIOCYANATE
LTD
### A II 3/31/2009 JUBILANT GENERICS LTD ALENDRONATE SODIUM USP
### A II 12/7/2010 JUBILANT GENERICS LTD ESOMEPRAZOLE MAGNESIUM DIHYDRATE
### A II 3/26/2009 JUBILANT GENERICS LTD PAROXETINE HYDROCHLORIDE-
USP(HEMIHYDRATE)
### A II 3/30/2009 JUBILANT GENERICS LTD RABEPRAZOLE SODIUM-USP (HYDRATE,
AMORPHOUS)
### I II 12/23/2008 SMS PHARMACEUTICALS LTD ARIPIPRAZOLE
### A II 12/23/2008 SMS PHARMACEUTICALS LTD ONDANSETRON HYDROCHLORIDE USP
### A III 12/17/2008 RELIANCE INDUSTRIES LTD RELENE 53EA010
### I II 12/17/2008 ESTEVE QUIMICA SA AMLODIPINE BESYLATE
### I III 11/24/2008 SHANDONG PHARMACEUTICAL GLASS ASSEMBLAGES FOR PREFILLED SYRINGES
CO LTD
Page 708
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I IV 11/18/2008 BRAHMAR CELLULOSE PRODUCTS CARBOXYMETHYLCELLULOSE SODIUM USP-NF
PRIVATE LTD
### I IV 11/18/2008 BRAHMAR CELLULOSE PRODUCTS MICROCRYSTALLINE CELLULOSE USP-NF
PRIVATE LTD
### I IV 11/18/2008 BRAHMAR CELLULOSE PRODUCTS CROSCARMELLOSE SODIUM USP-NF
PRIVATE LTD
### A II 12/24/2008 FARMAK AS ZOPICLONE
### A II 12/22/2008 BIOFER SPA HEPARIN SODIUM
### I II 12/23/2008 CHEMO IBERICA SA SEVELAMER HYDROCHLORIDE
### A II 12/22/2008 MSN PHARMACHEM PRIVATE LTD RANOLAZINE [ROUTE CODE - "RA"]
### A II 12/22/2008 PIERRE FABRE MEDICAMENT LEVOMILNACIPRAN
### I II 12/30/2008 SUN PHARMACEUTICAL INDUSTRIES TELMISARTAN USP (NON-STERILE BULK)
LTD
### I II 12/30/2008 RANBAXY LABORATORIES LTD MEROPENEM TECHNICAL
### A II 12/17/2008 MYLAN LABORATORIES LTD TIZANIDINE HYDROCHLORIDE USP
### I II 12/30/2008 AARTI DRUGS LTD TICLOPIDINE HYDROCHLORIDE
### A II 12/19/2008 NINGXIA QIYUAN PHARMACEUTICAL CO TETRACYCLINE HYDROCHLORIDE
LTD
### I II 12/30/2008 SUN PHARMACEUTICAL INDUSTRIES ORLISTAT (NON-STERILE BULK)
LTD
### A II 12/29/2008 SOLARA A PHARMA SCIENCES LTD ACITRETIN
### I III 11/21/2008 RITE SYSTEMS INC AMBER, LQC-BR1966-1
### A II 12/31/2008 SCINOPHARM TAIWAN LTD AZACITIDINE
### A V 12/31/2008 HOSPIRA INC STANDARD MICROBIOLOGICAL METHODS FOR
CONTRACT MANUFACTURED DRUG PRODUCT
PACKAGED IN GLASS VIALS AS MANUFACTURED
IN ROCKY MOUNT NC
### A II 12/24/2008 ALEMBIC PHARMACEUTICALS LTD CLONIDINE HYDROCHLORIDE USP
### A II 12/29/2008 CADILA HEALTHCARE LTD ESOMEPRAZOLE MAGNESIUM DIHYDRATE
### A II 12/30/2008 CADILA HEALTHCARE LTD LOSARTAN POTASSIUM USP
### A II 12/29/2008 TRIFARMA SPA EXEMESTANE
### A II 12/30/2008 MYLAN LABORATORIES LTD RASAGILINE MESYLATE
### A II 1/2/2009 KUMAR ORGANIC PRODUCTS LTD MINOXIDIL USP
### A II 12/27/2008 MYLAN LABORATORIES LTD FEXOFENADINE HYDROCHLORIDE
### A II 12/20/2008 MYLAN LABORATORIES LTD DEFERASIROX
### I II 12/27/2008 MATRIX LABORATORIES LTD OXCARBAZEPINE
### I II 12/27/2008 MYLAN LABORATORIES LTD DARIFENACIN HYDROBROMIDE
### A II 12/27/2008 MYLAN LABORATORIES LTD O-DESMETHYL VENLAFAXINE SUCCINATE
### I II 1/2/2009 SREENIVASA PHARMA PRIVATE LTD SIBUTRAMINE HYDROCHLORIDE
MONOHYDRATE
### A III 12/16/2008 GRAND PLAST CO LTD COLLAPSIBLE PLASTIC TUBES FOR
PHARMACEUTICAL PACKAGING
### A II 12/31/2008 MACLEODS PHARMACEUTICALS LTD LEVOFLOXACIN HEMIHYDRATE
### I II 12/31/2008 DR REDDYS LABORATORIES LTD ESOMEPRAZOLE MAGNESIUM DIHYDRATE
### A III 12/14/2008 TRIVENI POLYMERS PRIVATE LTD PLASTIC CAPS/CLOSURES
Page 709
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 12/23/2008 WINPAK HEAT SEAL PACKAGING INC FLEXIBLE PACKAGING MATERIALS
### A II 12/25/2008 MEGAFINE PHARMA P LTD DONEPEZIL HYDROCHLORIDE MONOHYDRATE
(FORM-1) USP (NON-STERILE DRUG
SUBSTANCE)
### A II 12/26/2008 MACLEODS PHARMACEUTICALS LTD DONEPEZIL HCL
### A II 1/6/2009 HETERO DRUGS LTD TOLTERODINE TARTRATE
### A II 1/4/2009 PERRIGO API LTD DONEPEZIL BASE
### I III 12/24/2008 SHANDONG PHARMACEUTICAL GLASS MESTRANOL 3-METHOXY-17-ETHINYL-ES
CO LTD POLYISOPRENE RUBBEER CAPS FOR NEEDLES
FOR PREFILLED SYRINGES
### I III 12/24/2008 SHANDONG PHARMACEUTICAL GLASS HALOGENATED BUTYL RUBBER PLUNGERS FOR
CO LTD PREFILLED
### I III 12/24/2008 SHANDONG PHARMACEUTICAL GLASS HALOGENATED BUTYL RUBBER PLUNGERS AND
CO LTD DISCS FOR PEN-INJECTORS
### I III 12/24/2008 SHANDONG PHARMACEUTICAL GLASS ALU-CAPS FOR PEN-INJECTORS
CO LTD
### A II 12/22/2008 LAURUS LABS LTD OXALIPLATIN USP
### I II 1/6/2009 DISHMAN PHARMACEUTICALS AND INDAPAMIDE
CHEMICALS LTD
### A II 1/7/2009 GENTHON BV TAMSULOSIN HYDROCHLORIDE
### A II 12/31/2008 NINGXIA QIYUAN PHARMACEUTICAL CO ERYTHROMYCIN
LTD
### A II 1/9/2009 MACLEODS PHARMACEUTICALS LTD FAMCICLOVIR
### I II 1/9/2009 DAIICHI SANKYO CO LTD SUN13837 DRUG SUBSTANCE
### I II 12/31/2008 CSPC ZHONGNUO PHARMACEUTICAL 6-AMINO-PENICILLANIC ACID (BY DIRECT
SHIJIAZHUANG CO LTD METHOD)
### I III 4/2/2012 TRASIS SA PACKAGING MATERIAL
### I IV 1/8/2009 SYMRISE INC 688617 EVOGLASS NATURAL FLAVOR
PINEAPPLE
### I IV 1/9/2009 SYMRISE INC 694942 EVOGLASS NATURAL & ARTIFICIAL
FLAVOR GRAPE
### I IV 1/8/2009 SYMRISE INC 688620 EVOGLASS NATURAL & ARTIFICIAL
ORANGE FLAVOR
### A III 12/22/2008 DANAPAK FLEXIBLES AS LAMINATE FILM FOR PACKAGING OF
PHARMACEUTICAL PRODUCTS, E.G.
TRANSDERMAL SYSTEMS
### A II 1/12/2009 SOLARA A PHARMA SCIENCES LTD TIOCONAZOLE
### A II 1/12/2009 SYMBIOTEC PHARMALAB PRIVATE LTD DESOXIMETASONE USP (MICRONIZED)
### A II 12/10/2008 CTX LIFE SCIENCES PVT LTD OXYMETAZOLINE HYDROCHLORIDE USP
### A IV 1/5/2009 CRODA INC SUPER REFINED ARLASOLVE DMI (DIMETHYL
ISOSORBIDE)
### A III 1/7/2009 CHARTER NEX FILMS INC 1019
### I II 1/16/2009 SMS PHARMACEUTICALS LTD ROSIGLITAZONE MALEATE
### A II 1/15/2009 LIGHT SCIENCES ONCOLOGY INC TALAPORFIN SODIUM (LS11) LYOPHILIZED DRUG
PRODUCT FORMULATION AND FILLING
Page 710
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 1/5/2009 NEWCHEM SPA BETAMETHASONE 17-VALERATE MICRONIZED
### A II 1/13/2009 EUTICALS SPA DIHYDROERGOTAMINE MESYLATE USP/EP
### A III 1/12/2009 3M DRUG DELIVERY SYSTEMS 3M SCOTCHPAK™ 9755 RELEASE LINER
### A III 1/16/2009 HUHTAMAKI RONSBERG HUHTAMAKI RONSBERG'S MULTI-LAYER
PACKAGING FILM
22411 A III 1/15/2009 RELIANCE INDUSTRIES LTD REPOL T200MK
### A III 1/15/2009 RELIANCE INDUSTRIES LTD REPOL R120MK
### A II 1/16/2009 SHANDONG NEW TIME KETOROLAC TROMETHAMINE (NON-STERILE,
PHARMACEUTICAL CO LTD BULK FORM)
### I IV 1/16/2009 FONA INTERNATIONAL INC 825.0003C CHERRY FLAVOR ARTIFICIAL
### I IV 1/16/2009 FONA INTERNATIONAL INC 856.0006C N-C GRAPE FLAVOR, ARTIFICIAL
### A III 1/15/2009 3M DRUG DELIVERY SYSTEMS DIV 3M COTRAN 9698 POLYURETHANE TAPE
### I II 1/29/2009 PFIZER INC LIPITOR (ATORVASTATIN CALCIUM) 10MG, 20MG,
40MG, 80MG ORALTABLETS
### A II 1/16/2009 GLENMARK PHARMACEUTICALS LTD SOLIFENACIN SUCCINATE
### I II 1/21/2009 ERREGIERRE SPA BUPROPION HYDROBROMIDE
### A II 1/22/2009 REGIS TECHNOLOGIES INC ACETAZOLAMIDE, USP
### A II 1/21/2009 FARMABIOS SPA CLOCORTOLONE PIVALATE (MICRONIZED)
### I II 12/26/2008 IND SWIFT LABORATORIES LTD NARATRIPTAN HYDROCHLORIDE USP
### I II 12/25/2008 ALP PHARM BEIJING CO LTD MEPROBAMATE (DRUG SUBSTANCE, NON-
STERILE)
### A II 12/10/2008 ZHEJIANG WILD WIND CARBIDOPA (NON-STERILE, BULK FORM)
PHARMACEUTICAL CO LTD
### A II 12/12/2008 ZHEJIANG WILD WIND METHYLDOPA (NON-STERILE, BULK FORM)
PHARMACEUTICAL CO LTD
### A II 1/21/2009 NECTAR LIFESCIENCES LTD CEFUROXIME AXETIL USP (AMORPHOUS)
### A II 1/20/2009 ESTEVE QUIMICA SA AZELASTINE HYDROCHLORIDE
### I IV 1/7/2009 CABOT SANMAR LTD CAB-O-SIL GRADE M-5 (FUMED SILICA)
### A II 1/6/2009 LIPOID GMBH LIPOID MCT (PH.EUR., USP)
### A II 1/7/2009 CHUNGHWA CHEMICAL SYNTHESIS AND OLOPATADINE HCL
BIOTECH CO LTD
### A II 1/15/2009 IOL CHEMICALS AND IBUPROFEN USP
PHARMACEUTICALS LTD
### I II 1/21/2009 RPG LIFE SCIENCES LTD RISPERIDONE USP
### I III 1/14/2009 AMPACET CORP AMPACET PRODUCT 181724 DELSYM AMBER
POLYPROPYLENE MASTERBATCH
### A II 1/22/2009 BHARAT PHARMA BTD 177: 17.7% NITROGLYCERIN IN SOLVATED
ADHESIVE
### A II 1/22/2009 BHARAT PHARMA NITROGLYCERIN AS IN DILUTED
NITROGLYCERIN, USP
### I II 3/23/2009 SUN PHARMACEUTICAL INDUSTRIES GLIMEPIRIDE USP
LTD
### A II 3/16/2009 SUN PHARMACEUTICAL INDUSTRIES SUN 8016 (LIOTHYRONINE SODIUM USP)
LTD
Page 711
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 3/16/2009 SUN PHARMACEUTICAL INDUSTRIES RILUZOLE USP
LTD
### A II 1/21/2009 STERLING SPA EXEMESTANE
### A II 1/6/2009 CADILA PHARMACEUTICALS LTD ESCITALOPRAM OXALATE USP
### A II 1/21/2009 BIO VECTRA INC ZERANOL
### A II 1/27/2009 JOHNSON MATTHEY INC LISDEXAETAMINE DIMESYLATE
PHARMACEUTICAL MATERIALS GROUP
### I II 1/21/2009 CADILA PHARMACEUTICALS LTD TELMISARTAN
### A II 1/20/2009 SHANDONG ZHONGYUAN GREENTECH CHONDROITIN SULFATE SODIUM
CO LTD
### I III 1/14/2009 TEKNOR APEX CO MEDALIST MD-220 NATURAL
### I III 1/7/2009 TEKNOR APEX CO MEDALIST MD-200 NATURAL
### I III 1/7/2009 TEKNOR APEX CO MEDALIST MD-205 NATURAL
### I III 1/7/2009 TEKNOR APEX CO MEDALIST MD-210 NATURAL
### I III 1/7/2009 TEKNOR APEX CO MEDALIST MD-215 NATURAL
### I III 1/14/2009 TEKNOR APEX CO MEDALIST MD-225 NATURAL
### A III 1/14/2009 TEKNOR APEX CO MEDALIST MD-230 NATURAL
### I III 1/14/2009 TEKNOR APEX CO MEDALIST MD-235 NATURAL
### I IV 1/27/2009 MASTERTASTE INC DBA KERRY 715770 - NATURAL AND ARTIFICIAL CHERRY
INGREDIENTS AND FLAVOURS FLAVOR
### I IV 1/27/2009 MASTERTASTE INC DBA KERRY 715846 - NATURAL LEMON FLAVOR WONF
INGREDIENTS AND FLAVOURS
### I IV 1/27/2009 MASTERTASTE INC DBA KERRY 715870 - NATURAL MINT FLAVOR WONF
INGREDIENTS AND FLAVOURS
### I IV 1/27/2009 MASTERTASTE INC DBA KERRY 716021 - NATURAL AND ARTIFICIAL MIXED
INGREDIENTS AND FLAVOURS BERRY FLAVOR
### I IV 1/27/2009 MASTERTASTE INC DBA KERRY 715990 - NATURAL ORANGE FLAVOR WONF
INGREDIENTS AND FLAVOURS
### I IV 1/27/2009 MASTERTASTE INC DBA KERRY 715787 - NATURAL AND ARTIFICIAL
INGREDIENTS AND FLAVOURS STRAWBERRY FLAVOR
### I IV 1/27/2009 MASTERTASTE INC DBA KERRY 715680 - NATURAL AND ARTIFICIAL
INGREDIENTS AND FLAVOURS WINTERGREEN FLAVOR
### A II 1/23/2009 CENTAUR PHARMACEUTICALS PVT LTD LORAZEPAM USP
### I IV 10/22/2008 FONA INTERNATIONAL INC 862.015 NAT & ART LEMON FLAVOR
### A III 11/24/2008 STARPET INC PERFORMANCE® PET 1708CC
### A II 1/16/2009 CHONGQING KANGLE CILOSTAZOL USP (DRUG SUBSTANCE, NON-
PHARMACEUTICAL CO LTD STERILE)
### A II 1/23/2009 AUROBINDO PHARMA LTD OXACILLIN FOR INJECTION USP (STERILE BULK)
Page 721
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 5/7/2009 EXXONMOBIL CHEMICAL CO BROMINATED ISOBUTYLENE -
PARAMETHYLSTYRENE RUBBER
### A II 5/12/2009 RELIANCE LIFE SCIENCES PVT LTD TEMOZOLOMIDE USP
### A II 5/14/2009 OLON SPA TROSPIUM CHLORIDE
### A III 5/8/2009 RELIANCE INDUSTRIES LTD RELENE B56003
### A IV 5/14/2009 YASUHARA CHEMICAL CO LTD YS RESIN PX 1150N
### I V 5/13/2009 LABORATOIRES THISSEN SA STERILIZATION PROCESS VALIDATION IN
APPLICATIONS FOR HUMAN AND VETERINARY
DRUG PRODUCTS LOCATED IN BRAINE I
ALLEUD BELGIUM
### A V 4/30/2009 PHASE V TECHNOLOGIES INC PHASE V OUTCOMES INFORMATION SYSTEM
### I II 5/15/2009 CF PHARMA LTD PENTOSAN POLYSULFATE SODIUM
### A II 5/15/2009 PAR A TECHNOLOGIES PRIVATE LTD RASAGILINE MESYLATE (NON STERILE BULK
DRUG SUBSTANCE)
### A III 5/11/2009 AMPACET CORP 111717 A WHITE PE MB
### A II 5/15/2009 SIGNA SA DE CV BICALUTAMIDE USP
### A II 5/18/2009 MSN PHARMACHEM PRIVATE LTD ATORVASTATIN CALCIUM USP(AMORPHOUS)
[ROUTE CODE - "ACA"]
### I II 5/13/2009 WUXI FORTUNE PHARMACEUTICAL CO MYCOPHENOLATE MOFETIL
LTD
### I II 5/14/2009 CHONGQING BIOCARE RIFABUTIN USP
PHARMACEUTICAL CO LTD
### A III 5/13/2009 AMPACET CORP 169625 BLUE POLYETHYLENE MASTERBATCH
### A II 5/15/2009 AUROBINDO PHARMA LTD PRAMIPEXOLE DIHYDROCHLORIDE USP
### I IV 5/20/2009 BASF SE KOLLIPHOR(R) TPGS
### A II 5/21/2009 EUMEDICA PHARMCEUTICALS AMPICILLIN AND SULBACTAM STERILE MIXTURE
INDUSTRIES
### A III 5/1/2009 JW LIFE SCIENCE MEDITUBE (MT-400)
### A III 5/1/2009 JW LIFE SCIENCE MEDIROLL (CT-800)
### I II 5/21/2009 EMCURE PHARMACEUTICALS LTD CYCLOPHOSPHAMIDE USP
### A II 3/23/2009 YUNG SHIN PHARMACEUTICAL MECLOFENAMATE SODIUM
INDUSTRIAL CO LTD
### A III 10/31/2009 IMARETCIOGLU LTD CO CLEAR ONE POINT CUT (OPC) AMPOUL
### A III 10/31/2009 IMARETCIOGLU LTD CO AMBER ONE POINT CUT (OPC) AMPOUL
### A III 5/8/2009 IMARETCIOGLU LTD CO AMBER COLOUR BREAK (CBR) AMPOUL
### A III 5/8/2009 IMARETCIOGLU LTD CO CLEAR COLOUR BREAK (CBR) AMPOUL
### A II 5/16/2009 LAURUS LABS LTD GEMCITABINE HYDROCHLORIDE USP
### A II 5/26/2009 APICORE US LLC AZACITIDINE
### A II 5/15/2009 NEWCHEM SPA DROSPIRENONE
### A IV 5/26/2009 SHOWA DENKO KK VISCOMATE
### A IV 5/7/2009 DEEPAK CELLULOSE PVT LTD HYPROMELLOSE PHTHALATE USP NF
### A III 5/19/2009 AMPACET CORP 112213 BLUE WHITE PE MB
### A III 5/19/2009 AMPACET CORP 11134 K SITE 34
### I II 5/15/2009 XIAN LIBANG PHARMACEUTICAL CO LTD SUCCINYLCHOLINE CHLORIDE
### A II 5/27/2009 APOTEX PHARMACHEM INDIA PVT LTD TROSPIUM CHLORIDE USP
Page 722
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 5/8/2009 ZHEJIANG APELOA JIAYUAN BUPROPION HYDROBROMIDE API
PHARMACEUTICAL CO LTD
### A II 6/15/2009 SOLARA A PHARMA SCIENCES LTD FELBAMATE
22811 A II 6/15/2009 COSMA SPA RANOLAZINE
### A II 5/29/2009 NATCO PHARMA LTD LETROZOLE (LER)
### A II 5/25/2009 UNIMARK REMEDIES LTD LAMOTRIGINE USP
### A IV 5/26/2009 NIPPON FINE CHEMICAL CO LTD A LIPOSOMAL EXCIPIENT GLYCERYL
TRICAPRYLATE (TRICAPRYLIN)
### A II 6/18/2009 NORAMCO INC OXYMORPHONE HYDROCHLORIDE DRUG
SUBSTANCE
### A III 5/15/2009 KOSMA KARE CANADA INC COTTON AND RAYON FIBER
### A III 5/26/2009 KARL OTTO BRAUN GMBH AND CO KG KOB 051 (ELASTIC POLYESTER FABRIC)
### A II 5/28/2009 APOTEX FERMENTATION INC MYCOPHENOLATE SODIUM
### A III 5/26/2009 ESSEL PACKAGING GUANGZHOU LTD LAMINATED TUBES
### A IV 5/22/2009 ABELEI INC 127A78 ARTIFICIAL CHERRY FLAVOR
### A IV 5/22/2009 ABELEI INC 148A41 ARTIFICIAL GRAPE FLAVOR
### A II 5/29/2009 ROTEM INDUSTRIES LTD MANNOSE TRIFLATE
### A II 5/29/2009 KYOWA PHARMA CHEMICAL CO LTD GP531T DRUG SUBSTANCE
### A II 6/1/2009 SUVEN LIFE SCIENCES LTD ARIPIPRAZOLE
### I IV 6/2/2009 LIFEBLOOD MEDICAL INC LIFORCELLr ACF PERFUSION MEDIA NOVEL
EXCIPIENT
### I IV 5/1/2009 CRODA INC SUPER REFINED PEANUT OIL NF
### I III 5/28/2009 DAE HEUNG IBN INC CONTAINER AND CLOSURE
### A II 6/2/2009 CHEMPACIFIC CORP JSP92476 DRUG SUBSTANCE
### I II 5/27/2009 AUROBINDO DATONG BIO PHARMA CO 6 AMINO PENICILLANIC ACID
LTD
### I V 5/29/2009 AUROBINDO PHARMA LTD STERILE MANUFACTURING FACILITY OF
AUROBINDO PHARMA LIMITED UNIT VI LOCATED
IN HYDERABAD INDIA
### A II 5/30/2009 AUROBINDO PHARMA LTD NAPROXEN SODIUM USP NON STERILE DRUG
SUBSTANCE
### I IV 6/2/2009 MASTERTASTE INC DBA KERRY INC 716252 NATURAL FLAVOR MODULATOR (SWEET)
FMT
### I IV 6/2/2009 MASTERTASTE INC DBA KERRY INC 716253 NATURAL FLAVOR MODULATOR (SWEET)
FMT
### A II 6/3/2009 CEDARBURG PHARMACEUTICALS INC TRAVOPROST A DRUG SUBSTANCE
### A III 6/5/2009 ESSEL PROPACK AMERICAS LLC LAMINATED TUBES
### I III 6/5/2009 ARISTA TUBES INC SUB ESSEL PLASTIC TUBES
PROPACK
### A II 6/4/2009 GE HEALTHCARE INC FASTLAB NAF CASSETTE PACK
### A II 6/1/2009 YUNNAN HANDE BIO-TECH CO LTD SEMI SYNTHETIC PACLITAXEL DRUG
SUBSTANCE
### I II 5/29/2009 ZHEJIANG JIANFENG HAIZHOU GUAIFENESIN
PHARMACEUTICAL CO LTD
### A II 6/9/2009 SANDOZ PRIVATE LTD TIGECYCLINE HYDROCHLORIDE
Page 723
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 6/9/2009 PRAVEEN LABORATORIES PVT LTD (R)-[1-(4 CHLOROPHENYL) PHENYL METHYL-1-
PIPERAZINE]
### A II 6/8/2009 CATALENT PHARMA SOLUTIONS LLC ESTRADIOL VAGINAL SOFT GELATIN CAPSULES
### A V 6/8/2009 WEST PHARMACEUTICAL SERVICES INC WESTAR RU GAMMA PROCESS ESCHWEILER
Page 725
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 6/29/2009 TEVA PHARMACEUTICAL INDUSTRIES ELETRIPTAN HYDROBROMIDE
LTD
### I II 6/29/2009 TEVA PHARMACEUTICAL INDUSTRIES MUPIROCIN CALCIUM DIHYDRATE
LTD
### I III 6/30/2009 APTAR RADOLFZELL GMBH CARTRIDGE PUMP SYSTEMS (CPS)
### A II 6/30/2009 ALCAMI WISCONSIN CORP FP-098
### A III 6/29/2009 AMPACET CORP 173409 SMC GREEN PE MB
### A III 6/23/2009 ROLLS PACK PVT LTD TAILOR MADE POLY BAGS
### A II 6/15/2009 ACS DOBFAR SPA ARGININE (STERILE BULK)
### A II 7/2/2009 CADILA HEALTHCARE LTD AZELASTINE HYDROCHLORIDE
### A III 6/19/2009 LAMINADOS FACARLYTE SA DE CV GASKET PACKAGING MATERIALS
### I II 7/1/2009 SYMED LABS LTD SIBUTRAMINE HYDROCHLORIDE
MONOHYDRATE
### A II 6/30/2009 APICORE US LLC BORTEZOMIB
### A II 6/15/2009 OLON SPA DAPTOMYCIN
### A II 7/6/2009 PAR A TECHNOLOGIES PRIVATE LTD PIOGLITAZONE HYDROCHLORIDE (NON-
STERILE) DRUG SUBSTANCE
### I II 7/8/2009 CADILA HEALTHCARE LTD PREGABALIN
### A II 7/8/2009 SOLARA A PHARMA SCIENCES LTD OSELTAMIVIR PHOSPHATE
### A II 7/7/2009 CAMBREX PROFARMACO MILANO SRL RALOXIFENE HYDROCHLORIDE
### A III 7/1/2009 AMPACET CORP 110402 WHITE PE MB
### A III 7/1/2009 SPLACK SA DESTAMP - DESICCANT TAMPER-EVIDENT
CLOSURES
### A II 7/8/2009 CADILA HEALTHCARE LTD AMLODIPINE BESYLATE USP
### A II 7/8/2009 SIGNA SA DE CV LAMIVUDINE METHANOL SOLVATE USP
### A II 7/6/2009 EUTICALS SPA ERGOTAMINE TARTRATE USP/EP
### A II 7/8/2009 SRIKEM LABORATORIES PVT LTD MECLIZINE HYDROCHLORIDE USP
### A III 7/8/2009 AMPACET CORP 191029 FDA BLACK PE MB
### I II 7/10/2009 SCINOPHARM TAIWAN LTD ARGATROBAN
### I II 6/25/2009 CTX LIFE SCIENCES PVT LTD METOPROLOL TARTRATE USP (ROUTE-I)
### A II 7/13/2009 DR REDDYS LABORATORIES LTD UDENAFIL
### I III 7/9/2009 AMPACET CORP 181092 K AMBER 092
### A II 6/30/2009 JOHNSON MATTHEY INC METHYLPHENIDATE FREE BASE
### A II 7/13/2009 SOLARA A PHARMA SCIENCES LTD SEVELAMER CARBONATE
### A II 7/10/2009 RA CHEM PHARMA LTD DOXAZOSIN MESYLATE USP
### I IV 7/14/2009 FONA INTERNATIONAL INC 852.0093U FRUIT PUNCH FLAVOR NAT WONF
### I II 9/29/2009 LUPIN LTD 7-AMINO-3-VINYL 3-CEPHEM-4-CARBOXYLIC
ACID(7-AVCA)
### A II 9/18/2009 LUPIN LTD EMTRICITABINE
### I II 7/14/2009 HY GRO CHEMICALS PHARMATEK D-OXYPHENE BASE (AN INTERMEDIATE FOR
PRIVATE LTD DEXTROPROPOXYPHENE HCI USP)
### A III 6/29/2009 GERRESHEIMER ZARAGOZA SA PLASTIC BOTTLES AND DROPPER BOTTLE
SYSTEMS
### A II 7/15/2009 SANOFI CHIMIE TRIAMCINOLONE ACETONIDE
### A IV 7/15/2009 BASF SE LUDIPRESS
Page 726
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 7/16/2009 SIGNA SA DE CV ACYCLOVIR USP
### A III 7/14/2009 AMPACET CORP 167378 SMC BLUE PP MB
### I III 7/17/2009 SHINKO CHEMICAL CO LTD EYEDROP CONTAINER UE-5
### A II 7/17/2009 GLENMARK PHARMACEUTICALS LTD FROVATRIPTAN SUCCINATE MONOHYDRATE
### A II 8/26/2009 USV PRIVATE LTD NARATRIPTAN HYDROCHLORIDE USP
### A II 7/17/2009 AARTI INDUSTRIES LTD CAPECITABINE
### A II 7/20/2009 CHANGZHOU QIANHONG BIO PHARMA HEPARIN SODIUM USP (NON STERILE BULK)
CO LTD
### A II 7/18/2009 HIKAL LTD VENLAFAXINE HYDROCHLORIDE API
### I II 7/17/2009 TEVA PHARMACEUTICAL INDUSTRIES ARMODAFINIL
LTD
### A II 7/15/2009 APICORE US LLC FELBAMATE USP
### A III 7/21/2009 HUHTAMAKI RONSBERG TUBE LAMINATES
### A III 7/16/2009 BERRY GLOBAL (BPREX PHARMA RISPHARM CONTAINER CLOSURE SYSTEM
PACKAGING INDIA PRIVATE LTD)
### A III 7/16/2009 BERRY GLOBAL (BPREX PHARMA DOUBLE SAFE CONTAINER CLOSURE SYSTEM
PACKAGING INDIA PRIVATE LTD)
### A II 7/21/2009 GLAND PHARMA LTD CISATRACURIUM BESYLATE
### A II 7/20/2009 AARTI INDUSTRIES LTD DESONIDE
### A II 7/21/2009 LEK PHARMACEUTICALS DD AMLODIPINE BESYLATE (PROCESS 2)
### A IV 7/20/2009 AMCOL HEALTH AND BEAUTY POLY-PORE® E100 POLYMER (ALLYL
SOLUTIONS INC METHACRYLATES CROSSPOLYMER)
### A II 8/19/2009 CIPLA LTD ARFORMOTEROL TARTRATE
### A II 7/18/2009 AUROBINDO PHARMA LTD OMEPRAZOLE MAGNESIUM USP (NON STERILE
DRUG SUBSTANCE)
### A II 7/21/2009 AARTI INDUSTRIES LTD MERCAPTOPURINE
### A II 7/21/2009 VALDEPHARM ESTRADIOL HEMIHYDRATE
### A II 7/22/2009 NEULAND LABORATORIES LTD SALMETEROL XINAFOATE USP
### A II 7/22/2009 INTERQUIM SA RIVASTIGMINE
### A II 7/16/2009 JOINT STOCK CO GRINDEKS DROPERIDOL USP
### A II 4/21/2009 HEBEI HUARONG PHARMACEUTICAL CO COBAMAMIDE
LTD
### I II 7/22/2009 HAUDONG MEDICINE CO LTD MYCOPHENOLATE MOFETIL
### I IV 7/23/2009 FONA INTERNATIONAL INC 825.0259U CHERRY FLAVOR NAT WONF
### A III 7/22/2009 KRAIBURG TPE GMBH AND CO KG THERMOLAST® M TM#MED
### A II 7/22/2009 AARTI INDUSTRIES LTD FLUTICASONE PROPIONATE USP
### I III 7/24/2009 GERRESHEIMER KUESSNACHT AG SPIROMAX INHALER
### A II 7/21/2009 SHIJIAZHUANG LONZEAL LAMIVUDINE
PHARMACEUTICALS CO LTD
### A II 7/24/2009 ACTAVIS GROUP PTC EHF ARMODAFINIL (NON STERILE BULK DRUG
SUBSTANCE)
### I III 7/21/2009 ST GOBAIN PERFORMANCE PLASTICS F1435
CORP
Page 727
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A V 7/24/2009 CATALENT BELGIUM SA PROCEDURES FOR STERILE OPERATIONS IN
CATALENT BELGIUM LOCATED IN BRUSSELS
BELGIUM
### I II 7/29/2009 R TECH UENO LTD UNOPROSTONE ISOPROPYL OPHTHALMIC
SOLUTION 0.15%
### A IV 7/27/2009 KAFRIT INDUSTRIES 1993 LTD MB CC 12720 LD WHITE
### A IV 7/22/2009 CRODA JAPAN KK SUPER REFINED CRODAMOL IPM UP LQ (JP)
### A II 8/3/2009 LUPIN LTD LEVOFLOXACIN HEMIHYDRATE USP
### I III 7/28/2009 PRESSPART GMBH CO KG ALUMINIUM ALLOY METERED DOSE INHALER
CONTAINERS (CANS) INTERNALLY COATED
WITH EPOXY PHENOLIC RESIN
### A II 7/28/2009 NORAMCO GMBH NALTREXONE DRUG SUBSTANCE
### A V 7/22/2009 MICROTROL STERILISATION SERVICES ETHYLENE OXIDE STERILISATION
PVT LTD
### A II 7/27/2009 APICORE US LLC FLUDROCORTISONE ACETATE USP
### A II 7/28/2009 SOLARA A PHARMA SCIENCES LTD ARTEMETHER
### I II 7/30/2009 APOTEX PHARMACHEM INDIA PVT LTD TOLTERODINE TARTRATE
### A II 7/31/2009 AARTI DRUGS LTD RIVASTIGMINE HYDROGEN TARTRATE
### A II 9/23/2009 CHATTEM CHEMICALS INC d-Methylphenidate Hydrochloride
### A II 7/31/2009 CADILA HEALTHCARE LTD MESALAMINE USP
### A II 6/12/2009 CENWAY PHARMACEUTICALS CO LTD 10 DABIII
### I II 7/31/2009 CADILA HEALTHCARE LTD ATORVASTATIN CALCIUM (CRYSTALLINE FORM I)
Page 729
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 8/13/2009 UNGERER AND CO NATURAL AND ARTIFICIAL BUBBLEGUM FLAVOR
FQ-5511
### A II 8/19/2009 TEVA PHARMACEUTICAL INDUSTRIES DOCETAXEL
LTD
### I III 8/10/2009 RAVIRAJ FOILS LTD ALUMINIUM FOIL CONTAINER
### A III 8/10/2009 RAVIRAJ FOILS LTD ALUMINIUM LIDDING FOIL (COATED/PRINTED)
### A III 8/10/2009 RAVIRAJ FOILS LTD ALUMINIUM BLISTER FOIL
(BARE/COATED/PRINTED)
### A III 8/10/2009 RAVIRAJ FOILS LTD ALUMINIUM STRIP FOIL
(BARE/LAMINATED/PRINTED)
### I II 8/20/2009 ALDRICH CHEMICAL CO ISOTEC CORTISOL-9, 11, 12, 12-D4, FOR EARLY CLINICAL
FACILITY TRIALS
### A III 8/21/2009 CODING PRODUCTS TTR-77190
### I II 8/20/2009 ZHEJIANG HISUN PHARMACEUTICAL CO MYCOPHENOLIC ACID NON-STERILE A
LTD PHARMACEUTICAL INGREDIENT
### A II 8/21/2009 AMRI RENSSELAER INC SUB ALBANY TARTARIC ACID NF DRUG SUBSTANCE
MOLECULAR RESEARCH INC
### I II 8/19/2009 FLEMING LABORATORIES LTD CYCLOBENZAPRINE HYDROCHLORIDE USP
BULK
### I II 8/20/2009 BIOPHARM GMBH RHGDF-5 (RECOMBINANT HUMAN
GROWTH/DIFFERENTIATION FACTOR 5)
### I II 8/24/2009 HANGZHOU ZHONGMEI HUADONG MYCOPHENOLIC ACID
PHARMACEUTICAL CO LTD
### A II 8/26/2009 SMS PHARMACEUTICALS LTD RIZATRIPTAN BENZOATE
### A II 8/21/2009 PAR A TECHNOLOGIES PRIVATE LTD SILDENAFIL CITRATE (NON-STERILE BULK DRUG
SUBSTANCE)
### A II 8/24/2009 AUROBINDO PHARMA LTD REPAGLINIDE USP (NON-STERILE DRUG
SUBSTANCE)
### I II 8/19/2009 POLYDRUG LABORATORIES PVT LTD CHLOROBUTANOL (HEMIHYDRATE)
### A II 8/10/2009 VIRUPAKSHA ORGANICS PVT LTD FEXOFENADINE HCL (FORM-1) USP
### I IV 8/25/2009 AVANTOR PERFORMANCE MATERIALS PANEXCEA TM MHC300G
INC
### A II 8/17/2009 TANGSHAN SANXIN BIOCHEMICAL CHONDROITIN SULFATE SODIUM
PRODUCT CO LTD
### A III 8/4/2009 SSF PLASTICS INDIA PRIVATE LTD EYE EAR & NASAL DROPPER VIALS AND DRY
SYRUP BOTTLE SET
### I IV 8/1/2009 CRODA INC ARLACEL P135 (PEG 30
DIPOLYHYDROXYSTEARATE)
### A II 8/20/2009 DISHMAN CARBOGEN AMCIS LTD OCTENIDINE HYDROCHLORIDE
### I II 8/26/2009 FARCHEMIA SRL IMIPRAMINE PAMOATE
### A II 8/28/2009 TEVA PHARMACEUTICAL INDUSTRIES DONEPEZIL HYDROCHLORIDE
LTD
### A II 8/28/2009 JUNGBUNZLAUER LADENBURG GMBH ANHYDROUS CITRIC ACID
### I II 8/28/2009 APOTEX PHARMACHEM INC SUMATRIPTAN SUCCINATE USP
### A II 8/31/2009 UQUIFA MEXICO SA DE CV PYRANTEL TARTRATE ZEOLEX
Page 730
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I IV 9/3/2009 FONA INTERNATIONAL INC 829.0013U FONATECHr CLOUDING BLEND
### I III 8/31/2009 LOPAREX LLC GRADE 45821 D 4.0 WH HDP U4195/000
### A II 9/3/2009 SIEGFRIED PHARMACHEMIKALIEN PHENYLEPHRINE HYDROCHLORIDE
MINDEN GMBH
### A II 8/31/2009 AUROBINDO PHARMA LTD IRBESARTAN USP (NON-STERILE DRUG
SUBSTANCE)
### I II 9/4/2009 SEQUENT SCIENTIFIC LTD STAVUDINE
### A IV 9/2/2009 KOEL COLOURS PVT LTD LAKE COLOURS
### A IV 9/2/2009 KOEL COLOURS PVT LTD IRON OXIDE COLOURS
### A II 8/28/2009 PARABOLIC DRUGS LTD CEFUROXIME ACID
### I II 7/31/2009 SAFC BIOSCIENCES INC EX-CELL EBX® GRO I, SERUM-FREE MEDIUM
FOR EMBRYONIC STEM CELLS, W/O L-
GLUTAMINE, W/O PHENOL RED
### I II 7/31/2009 SAFC BIOSCIENCES INC EX-CELL EBX® GRO II, SERUM-FREE MEDIUM
FOR EMBRYONIC STEM CELLS, W/O L-
GLUTAMINE
### I II 7/31/2009 SAFC BIOSCIENCES INC EX-CELL EBX® GRO I, SERUM-FREE MEDIUM
FOR EMBRYONIC STEM CELLS, W/O L-
GLUTAMINE, W/O PHENOL RED, W/O SODIUM
BICARBONATE
### I II 7/31/2009 SAFC BIOSCIENCES INC 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
### I II 7/31/2009 SAFC BIOSCIENCES INC EX-CELL EBX® GRO II, SERUM-FREE MEDIUM
FOR EMBRYONIC STEM CELLS, W/O L-
GLUTAMINE, W/O SODIUM BICARBONATE
### I II 7/31/2009 SAFC BIOSCIENCES INC EX-CELL CD CHO FUSION, ANIMAL-COMPONENT
FREE, SERUM-FREE MEDIUM, CHEMICALLY
DEFINED, W/O L-GLUTAMINE
### A II 7/31/2009 SAFC BIOSCIENCES INC EX-CELL CD CHO FUSION, ANIMAL-COMPONENT
FREE, SERUM-FREE MEDIUM, CHEMICALLY
DEFINED, W/O L-GLUTAMINE, W/O SODIUM
BICARBONATE
### I II 8/6/2009 SAFC BIOSCIENCES INC EX-CELL CD HYDROLYSATE FUSION, ANIMAL
COMPONENT FREE, CHEMICALLY-DEFINED
LIQUID MEDIA, (PRODUCT NO. 14700C), DRY
POWDER MEDIA (PRODUCT NO. 24700C)
### A II 9/3/2009 ST GOBAIN PERFORMANCE PLASTICS SANI-TECHr ULTRA 50 SILICONE TUBING
CORP
### A II 9/8/2009 MERCK KGAA BORIC ACID
### A IV 8/31/2009 NECTAR LIFESCIENCES LTD HARD GELATIN CAPSULE SHELL
### A II 9/9/2009 SOLARA A PHARMA SCIENCES LTD CARISOPRODOL USP
### I II 9/10/2009 CADILA HEALTHCARE LTD OXALIPLATIN PH EUR
### A II 9/4/2009 MEGAFINE PHARMA P LTD VENLAFAXINE HYDROCHLORIDE USP
Page 731
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 9/9/2009 CERBIOS PHARMA SA CALCIPOTRIENE ANHYDROUS
### I IV 9/11/2009 SPI PHARMA INC ADVANTOL 300
### A II 7/8/2009 NANDU CHEMICALS PVT LTD SODIUM CHLORIDE BP (PARENTERAL GRADE)
### A III 9/14/2009 PRO PALS INDUSTRIES LTD FOAM LDPE LINER
### I II 9/10/2009 ZHEJIANG HISOAR PHARMACEUTICAL KETO
CO LTD
### A II 9/11/2009 ALEMBIC PHARMACEUTICALS LTD MEMANTINE HYDROCHLORIDE USP
### I II 9/14/2009 HANGZHOU ZHONGMEI HUADONG SIROLIMUS
PHARMACEUTICAL CO LTD
23110 A II 9/14/2009 TORRENT PHARMACEUTICALS LTD ESOMEPRAZOLE MAGNESIUM USP
23111 I IV 9/8/2009 KERRY BIOFUNCTIONAL INGREDIENTS LUBRITOSE AN
INC DBA KERRY BIO SCIENCE
23112 I IV 9/9/2009 KERRY BIOFUNCTIONAL INGREDIENTS DISINTEQUIK
INC DBA KERRY BIO SCIENCE
23113 I IV 9/9/2009 KERRY BIOFUNCTIONAL INGREDIENTS DISINTEQUIK MCC
INC DBA KERRY BIO SCIENCE
23114 A III 9/15/2009 ELM PLASTIC GMBH PLASTIC DOSING PIPETTES (SHORT FORM)
23115 A II 9/30/2009 LUPIN LTD CLINDAMYCIN PALMITATE HYDROCHLORIDE
USP
23116 A II 9/10/2009 MEISSNER FILTRATION PRODUCTS INC TEPOFLEX BIOCONTAINERS
23117 A II 9/18/2009 CATALENT PHARMA SOLUTIONS LLC PROCARDIA SOFTGELS 10 MG (NIFEDIPINE)
23118 A II 9/16/2009 FARMABIOS SPA BETAMETHASONE DIPROPIONATE MICRONIZED
23119 A II 9/15/2009 MEISSNER FILTRATION PRODUCTS INC EVERLUX FILTER CARTRIDGES
### A II 9/16/2009 MYLAN LABORATORIES LTD ESOMEPRAZOLE MAGNESIUM USP
(AMORPHOUS) (PROCESS II)
### A II 9/21/2009 RAKS PHARMA PVT LTD TRAMADOL HYDROCHLORIDE USP
### A III 11/25/2008 EMS CHEMIE NORTH AMERICA INC GRILAMID TR 60 NATURAL
### I II 9/23/2009 SHILPA MEDICARE LTD ANASTROZOLE
### I II 9/23/2009 SEQUENT SCIENTIFIC LTD NEVIRAPINE ANHYDROUS
### A II 9/22/2009 ION EXCHANGE INDIA LTD CALCIUM POLYSTYRENE SULFONATE BP 2007
(INDION-404)
### I II 10/6/2009 BASF PHARMA CALLANISH LTD DOCOSAHEXAENOIC ACID ETHYL ESTER (DHA
90 EE)
### I III 9/18/2009 AMPACET CORP 190826 HP BLACK PE MB
### A II 9/25/2009 DR REDDYS LABORATORIES LTD GRANISETRON
### A II 10/7/2009 JUBILANT GENERICS LTD PALIPERIDONE
### A II 9/28/2009 TEVA PHARMACEUTICAL INDUSTRIES CISATRACURIUM BESYLATE
LTD
### A III 9/24/2009 AMERICHEM INC 46538 CD4 WHITE COLORANT
### A II 9/28/2009 RELIABLE BIOPHARMACEUTICAL LLC DEXMEDETOMIDINE HCI
### A II 9/28/2009 ERREGIERRE SPA DULOXETINE HYDROCHLORIDE EP-USP
### A II 10/27/2009 LUPIN LTD ARMODAFINIL
### I II 9/28/2009 DERIVADOS QUIMICOS SA FINE IPRATROPIUM BROMIDE
CHEMICALS
### I II 7/27/2009 TAI HENG INDUSTRY CO LTD ERLOTINIB HYDROCHLORIDE
Page 732
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 9/29/2009 JINAN JINDA PHARMACEUTICAL NITROFURAZONE
CHEMISTRY CO LTD
### A II 9/24/2009 LAURUS LABS LTD DOCETAXEL ANHYDROUS USP
### I II 10/1/2009 MYLAN LABORATORIES LTD IMATINIB MESYLATE
### A II 9/30/2009 JOHNSON MATTHEY PHARMA SERVICES 4116.E
### I III 9/30/2009 A SUNG PLASTIC IND CO LTD CONTAINER & CLOSURE
### A II 9/30/2009 SANOFI CHIMIE NALOXONE HYDROCHLORIDE
### A II 9/25/2009 ZHEJIANG CANDORLY (R) -9-[2-
PHARMACEUTICAL CO LTD (PHOSPHONMETHOXY)PROPYL]ADENINE AN
INTERMEDIATE FOR TENOFOVIR DISOPROXIL
FUMARATE
### A II 9/30/2009 MEDICHEM SA LOXAPINE BASE
### A II 9/30/2009 MEDICHEM SA TAMSULOSIN HYDROCHLORIDE(MED-201750/E)
### A II 10/2/2009 AMINO CHEMICALS LTD (R)-MODAFINIL
### I II 9/29/2009 WUHAN WUYAO PHARMACEUTICAL CO CHLOROPROCAINE HYDROCHLORIDE USP
LTD (NON-STERILE BULK DRUG SUBSTANCE)
### I II 10/2/2009 HOVIONE FARMACIENCIA SA IOHEXOL
### I IV 10/6/2009 CAFOSA GUM SA HEALTH IN GUM PWD-01
### A II 10/5/2009 SIGNA SA DE CV VALSARTAN USP
### I II 10/6/2009 NISSAN CHEMICAL INDUSTRIES LTD NTC-801F
### A IV 9/29/2009 HENKEL CORP DURO-TAK® 87-611A PRESSURE SENSITIVE
ADHESIVE
### A II 9/30/2009 VENKATA NARAYANA A INGREDIENTS OLMESARTAN MEDOXOMIL
PRIVATE LTD
### I II 9/25/2009 DALIAN ZHEN AO BIO TECH CO LTD ADENOSINE 5' -MONOPHOSPHATE FREE ACID
### I II 9/18/2009 ALP PHARM BEIJING CO LTD ERGOCALCIFEROL USP
### I II 9/25/2009 ALP PHARM BEIJING CO LTD D-PENICILLAMINE USP
### I II 9/30/2009 BIOVET JOINT STOCK CO TESTOSTERONE
### A II 10/6/2009 FORMOSA LABORATORIES INC TEMOZOLOMIDE
### I IV 10/5/2009 SYMRISE INC 695292 EVOGLASSr NATURAL & ARTIFICIAL
FLAVOR CHERRY
### A II 10/5/2009 MYLAN LABORATORIES LTD TEMAZEPAM USP
### A II 10/9/2009 AARTI DRUGS LTD CELECOXIB
### A II 10/7/2009 CSPC WEISHENG PHARMACEUTICAL ASCORBIC ACID (VITAMIN C)
SHIJIAZHUANG CO LTD
### A II 10/7/2009 MACLEODS PHARMACEUTICALS LTD PRAMIPEXOLE DIHYDROCHLORIDE
MONOHYDRATE USP
### I II 10/8/2009 EMCURE PHARMACEUTICALS LTD SEVELAMER CARBONATE (E SUB)
### A II 10/5/2009 JOST CHEMICAL CO POTASSIUM SULFATE
### I IV 10/8/2009 ARMARK AUTHENTICATION EXCIPIENT ON DOSE (EOD) GRADE COVERT
TECHNOLOGIES LLC MARKERS(CM): A PHYSICAL CHEMICAL
IDENTIFIER (PCID) UTILIZED FOR
PHARMACEUTICAL BRAND PROTECTION
### A II 10/9/2009 ACS DOBFAR SPA CEFTAROLINE FOSAMIL STERILE DRUG
SUBSTANCE
Page 733
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 10/6/2009 ANUS LABORATORIES LTD CIS (+) HYDROXY LACTAM
### I II 9/30/2009 CHONGQING CARE LIFE ALENDRONATE SODIUM NON-STERILE BULK
PHARMACEUTICAL CO LTD DRUG SUBSTANCE
### A II 10/14/2009 AMOLI ORGANICS PVT LTD CARBAMAZEPINE USP
### A II 10/5/2009 ION EXCHANGE INDIA LTD CHOLESTYRAMINE RESIN USP (INDION 454)
### A II 9/22/2009 GLAND PHARMA LTD DEXRAZOXANE
### A II 10/7/2009 GLAND PHARMA LTD TIROFIBAN HYDROCHLORIDE
### A II 10/9/2009 AUROBINDO PHARMA LTD TORSEMIDE USP (NON-STERILE DRUG
SUBSTANCE)
### A II 10/7/2009 EUTICALS SPA LITHIUM CARBONATE PHARMA GRADE
### A III 11/11/2009 WEENER EMPIRE PLASTICS LTD HIGH DENSITY POLYETHYLENE BOTTLES
### A II 10/15/2009 CRYSTAL PHARMA SAU NESTORONE®
### I II 10/14/2009 ZHEJIANG HUAHAI PHARMACEUTICAL DONEPEZIL HYDROCHLORIDE (PROCESS II)
CO LTD USP
### A II 10/13/2009 RAKS PHARMA PVT LTD AZATHIOPRINE USP
### A II 10/13/2009 KANEKA EUROGENTEC SA PRODUCTION OF PLASMID DNA
### A II 10/15/2009 JW PHARMACEUTICAL CORP CILASTATIN ACID
### I III 10/14/2009 COVESTRO LLC MAKROLON DP1-1869 AND MAKROLON AM2428
RESINS
### A II 10/16/2009 TEVA PHARMACEUTICAL INDUSTRIES ERLOTINIB HCL
LTD
### I II 10/16/2009 EMCURE PHARMACEUTICALS LTD EMTRICITABINE
### I II 7/31/2009 SAFC BIOSCIENCES INC EX-CELL EBXr PRO-I SERUM-FREE MEDIUM FOR
EMBRYONIC STEM CELLS W/O L-GLUTAMINE
W/O PHENOL RED W/O SODIUM BICARBONATE
Page 735
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 10/28/2009 HSIAO SUNG NON OXYGEN CHEMICAL SORB OO - OXYGEN ABSORBERS
CO LTD
### I III 10/30/2009 AMPACET CORP 102837 DESICCANT PE MB
### A III 10/30/2009 COLORS FOR PLASTICS INC THERMOPLASTIC RESIN COLORANT
MASTERBATCH R29213 RED
### A II 10/30/2009 GLAND PHARMA LTD DEXMEDETOMIDINE HYDROCHLORIDE USP
### A II 4/7/2010 LUPIN LTD DOXERCALCIFEROL
### I II 10/23/2009 CADILA HEALTHCARE LTD ESCITALOPRAM OXALATE (FORM -1)
### A II 10/30/2009 MCGUFF PHARMACEUTICALS INC ASCOR L 500® (ASCORBIC ACID INJECTION
USP)
### A III 10/29/2009 HSIAO SUNG NON OXYGEN CHEMICAL O-BUSTERr OXYGEN ABSORBERS
CO LTD
### I II 10/23/2009 COVALENT LABORATORIES PRIVATE LTD CEFUROXIME AXETIL USP (CRYSTALLINE)
### A III 11/2/2009 TOPPAN PRINTING CO LTD HP-3 PACKAGE FOR TRANSDERMAL DRUG
DELIVERY PATCHES
### A II 11/2/2009 FINE CHEMICALS CORP PTY LTD ROPIVACAINE
### A II 10/30/2009 FIS FABBRICA ITALIANA SINTETICI SPA OLOPATADINE HYDROCHLORIDE
### A II 11/2/2009 AREVIPHARMA GMBH BISOPROLOL FUMARATE
### A II 11/3/2009 IPC PROCESS CENTER GMBH AND CO IBUPROFEN DC100 (IBUPROFEN PH. EUR.,
KG GRANULATED)
### I II 11/2/2009 HAINAN POLY PHARMACEUTICAL CO DICLOFENAC SODIUM EXTENDED RELEASE
LTD CAPSULES
### I II 11/2/2009 HAINAN POLY PHARMACEUTICAL CO THEOPHYLLINE EXTENDED RELEASE
LTD CAPSULES
### A II 12/24/2009 LUPIN LTD RANOLAZINE
### A II 11/6/2009 PHARMACOSMOS AS 24% IRON ISOMALTOSIDE POWDER
### A II 11/5/2009 MALLADI DRUGS AND LORAZEPAM
PHARMACEUTICALS LTD
### I II 11/9/2009 CHINOIN PHARMACEUTICAL AND DINOPROST
CHEMICAL WORKS PRIVATE CO LTD
### A II 11/9/2009 CHINOIN PHARMACEUTICAL AND MISOPROSTOL
CHEMICAL WORKS PRIVATE CO LTD
### A II 11/5/2009 MOEHS IBERICA SL FENOFIBRATE
### A II 11/4/2009 RA CHEM PHARMA LTD LAMOTRIGINE USP
### A II 12/2/2009 ACOM CORP SODIUM [124I] IODIDE
### A III 11/5/2009 PRESSPART MANUFACTURING SA INTRANASAL DEVICE COMPONENTS AND SUB-
ASSEMBLY
### A II 11/5/2009 UNIMARK REMEDIES LTD LANTHANUM CARBONATE OCTAHYDRATE
### A II 11/11/2009 MSN LABORATORIES PRIVATE LTD BOSENTAN MONOHYDRATE [ROUTE CODE - 'BN']
Page 740
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/17/2009 EVERLIGHT CHEMICAL INDUSTRIAL LUBIPROSTONE
CORP
### A V 12/21/2009 SANDOZ GMBH STERILIZATION PROCESS VALIDATION
INFORMATION FOR THE STERILE
CEPHALOSPORIN CRYSTALLIZATION PLANT
### I II 12/14/2009 BACHEM SA DORZOLAMIDE HYDROCHLORIDE
### I II 12/21/2009 MITSUBISHI TANABE PHARMA CORP MT-7716 DRUG SUBSTANCE
### A II 12/18/2009 SCINOPHARM TAIWAN LTD DECITABINE
### I II 12/18/2009 CHEMO IBERICA SA SEVELAMER CARBONATE
### A II 2/22/2010 SUN PHARMACEUTICAL INDUSTRIES NALOXONE HYDROCHLORIDE DIHYDRATE USP
LTD
### A II 12/18/2009 EUTICALS INC CHOLINE FENOFIBRATE DRUG SUBSTANCE
### A III 12/18/2009 JSR CORP ARTON SERIES
### I IV 12/18/2009 FONA INTERNATIONAL INC 856.0196U GRAPE FLAVOR ART
### A III 12/18/2009 EI DUPONT DE NEMOURS INC DUPONT APPEEL LIDDING RESINS
### A III 12/21/2009 COIM USA INC NOVACOTE NC-9170-23MAC WITH CO-
REACTANT CA-350 PU
### I V 12/18/2009 NANOINK INC PHARMACEUTICAL BRAND PROTECTION AND
ANTI-COUNTERFEITING INSTRUMENTATION AND
PROCESS FOR HARD CAPSULES
### A II 12/22/2009 SRI KRISHNA PHARMACEUTICALS LTD FUROSEMIDE USP
### A II 1/12/2010 LUPIN LTD DROSPIRENONE USP
### A II 3/12/2010 LUPIN LTD IRBESARTAN USP (PROCESS B)
### A II 12/21/2009 FINE CHEMICALS CORP PTY LTD FCC-7280
### A II 12/15/2009 SYN-TECH CHEM AND PHARM CO LTD RABEPRAZOLE SODIUM
### A II 12/23/2009 PAR A TECHNOLOGIES PRIVATE LTD RANOLAZINE (NON-STERILE BULK DRUG
SUBSTANCE)
### I II 12/23/2009 TEVA PHARMACEUTICAL INDUSTRIES LUBIPROSTONE
LTD
### I II 12/22/2009 SIEGFRIED USA INC OXYMORPHONE HYDROCHLORIDE USP
### A II 12/14/2009 CHEMISCHE FABRIK BERG GMBH PHENOBARBITAL USP
### I II 12/22/2009 POLYDRUG LABORATORIES PVT LTD FLUCONAZOLE
### A II 12/16/2009 CENWAY PHARMACEUTICALS CO LTD DOCETAXEL
### I III 12/21/2009 AMPACET CORP 603192-PT UVA PET MB
### A II 12/23/2009 THE SUZUKI MENTHOL CO LTD L-MENTHOL USP/JP
### A II 12/29/2009 MYLAN LABORATORIES LTD VORINOSTAT
### A II 12/29/2009 MYLAN LABORATORIES LTD LENALIDOMIDE
23411 A II 12/29/2009 MYLAN LABORATORIES LTD LETROZOLE USP
### I II 12/28/2009 RANBAXY LABORATORIES LTD ENTACAPONE
### I II 12/29/2009 RANBAXY LABORATORIES LTD TROSPIUM CHLORIDE (NON-STERILE BULK)
### A II 12/29/2009 TEVA PHARMACEUTICAL INDUSTRIES SUNITINIB MALATE
LTD
### I II 12/15/2009 AANJANEYA LIFECARE LTD QUININE SULPHATE USP DRUG SUBSTANCE
### A II 12/22/2009 CHEMWERTH INC AZACITIDINE NON-STERILE BULK DRUG
SUBSTANCE
Page 741
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/28/2009 CHEMWERTH INC PEMETREXED DISODIUM NON-STERILE BULK
DRUG SUBSTANCE
### A II 12/31/2009 ACS DOBFAR SPA AMPA
### A II 6/30/2010 CHATTEM CHEMICALS INC OXYCODONE HYDROCHLORIDE, USP
### A IV 12/18/2009 DDP SPECIALTY ELECTRONIC DOW CORNING™Q7-9180 SILICONE FLUIDS
MATERIALS US 9 LLC
### I II 12/30/2009 WUHAN WUYAO PHARMACEUTICAL CO METRONIDAZOLE
LTD
### A II 12/29/2009 MACLEODS PHARMACEUTICALS LTD VALACICLOVIR HYDROCHLORIDE DIHYDRATE
### A II 12/28/2009 SCINOPHARM TAIWAN LTD TRAVOPROST USP
### I II 12/28/2009 ALP PHARM BEIJING CO LTD ESZOPICLONE
### A II 12/29/2009 SOUTHWEST SYNTHETIC SIMVASTATIN USP
PHARMACEUTICAL CORP LTD
### A II 12/31/2009 ALEMBIC PHARMACEUTICALS LTD DONEPEZIL HYDROCHLORIDE MONOHYDRATE
USP
### A II 1/5/2010 INDUSTRIALE CHIMICA SRL FLUTICASONE PROPIONATE USP
### A II 1/5/2010 INDUSTRIALE CHIMICA SRL DIENOGEST
### A III 7/21/2009 ASTRA PLASTIQUE CLOSURE: REFERENCE 1442
### A II 1/6/2010 MYLAN LABORATORIES LTD LAMIVUDINE USP (LVD)
### I II 1/6/2010 CADILA HEALTHCARE LTD RANOLAZINE
### I II 1/6/2010 CADILA HEALTHCARE LTD GEMCITABINE HYDROCHLORIDE USP
### A II 1/6/2010 CHUNGHWA CHEMICAL SYNTHESIS AND METAXALONE USP
BIOTECH CO LTD
### I II 1/6/2010 CHUNGHWA CHEMICAL SYNTHESIS AND MYCOPHENOLATE SODIUM
BIOTECH CO LTD
### A II 12/31/2009 AUROBINDO PHARMA LTD CLINDAMYCIN PALMITATE HYDROCHLORIDE
USP (NON-STERILE DRUG SUBSTANCE)
### A II 1/4/2010 CERBIOS PHARMA SA CALCIUM LEVOFOLINATE
### A II 12/31/2009 NECTAR LIFESCIENCES LTD 7-AMINO-3-VINYL-3-CEPHEM-4-CARBOXYLIC
ACID (7-AVCA) [NON-STERILE DRUG
SUBSTANCE INTERMEDIATE]
### A II 1/7/2010 CADILA HEALTHCARE LTD CLOPIDOGREL BISULFATE USP (FORM-I) (CUE
ROUTE)
### I II 1/8/2010 SCI PHARMTECH INC DULOXETINE HYDROCHLORIDE (FROM (S)-
MMAA-OME)
### A II 1/12/2010 MYLAN LABORATORIES LTD VARENICLINE TARTRATE
### A II 1/8/2010 MSN PHARMACHEM PRIVATE LTD SUMATRIPTAN USP [ROUTE CODE - "SN"]
### A II 1/11/2010 EMCURE PHARMACEUTICALS LTD TOPOTECAN HYDROCHLORIDE
### I II 1/7/2010 PROVENTUS LIFE SCIENCES PVT LTD PRIMIDONE
### A III 1/11/2010 TEIJIN FRONTIER CO PET RESIN GRADE TPL-SD
### I II 1/8/2010 ALP PHARM BEIJING CO LTD CIDOFOVIR DIHYDRATE
### A III 1/12/2010 TRIMAR INTERNATIONAL CORP HIGH DENSITY POLYETHYLENE (HDPE)
BOTTLES
### A II 5/26/2010 JUBILANT GENERICS LTD ESOMEPRAZOLE MAGNESIUM (AMORPHOUS)
USP
Page 742
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 1/11/2010 MACLEODS PHARMACEUTICALS LTD IRBESARTAN
### I II 1/7/2010 LAURUS LABS LTD TENOFOVIR DISOPROXIL FUMARATE
### I II 1/11/2010 HUANGSHI MEIFENG CHEMICAL CO LTD SULISOBENZONE
### I V 1/11/2010 THE SURGEON GENERAL DEPT OF THE SKIN EXPOSURE REDUCTION PASTE AGAINST
ARMY CHEMICAL WARFARE AGENTS (SERPACWA)
LOCATED IN FORT DETRICK MARYLAND
### A II 1/11/2010 PARABOLIC DRUGS LTD CEFUROXIME AXETIL CRYSTALLINE ( PROCESS-
II )
### A III 1/14/2010 KANEKA BELGIUM NV KANE ACE B-28A
### A II 1/14/2010 AMINO CHEMICALS LTD BOSENTAN MONOHYDRATE
### A II 8/3/2010 SHANGHAI ZIYUAN PHARMACEUTICAL NAFTIFINE HYDROCHLORIDE
CO LTD
### A II 1/8/2010 QILU PHARMACEUTICAL CO LTD DOCETAXEL USP
### A II 1/15/2010 EMCURE PHARMACEUTICALS LTD SEVELAMER CARBONATE (FOR POWDER
FORMULATION)
### A II 1/18/2010 DR REDDYS LABORATORIES LTD RASAGILINE MESYLATE
### A II 1/15/2010 CYALUME SPECIALTY PRODUCTS INC CHLORPHENIRAMINE TANNATE
### I III 1/15/2010 DA PRO RUBBER INC PACKAGING MATERIAL
### A III 1/15/2010 MINNESOTA RUBBER AND PLASTICS A RUBBER FLUOROELASTOMER FOR SEALING
APPLICATIONS IN MEDICAL DEVICES
### A II 1/14/2010 OLON SPA CHOLINE FENOFIBRATE
### A II 1/20/2010 MSN LABORATORIES PRIVATE LTD EPLERENONE [ROUTE CODE: PL]
### I II 1/15/2010 WANBURY LTD CARVEDILOL PHOSPHATE MONOHYDRATE
### A III 1/8/2010 HB FULLER CO PHC9255
### I II 1/12/2010 CHANGZHOU AHK TECH INC CYTARABINE USP NON-STERILE BULK DRUG
### A III 1/18/2010 GREEN PACK FOILS PRIVATE LTD ALUMINIUM STRIP FOIL (LAMINATED/PRINTED)
### A III 1/18/2010 GREEN PACK FOILS PRIVATE LTD ALUMINIUM BLISTER FOIL (COATED/PRINTED)
### A II 1/21/2010 DR REDDYS LABORATORIES LTD TELMISARTAN (PROCESS-II) USP
### I II 1/21/2010 TORRENT PHARMACEUTICALS LTD CLOPIDOGREL BISULPHATE FORM-I
### A II 1/18/2010 PARABOLIC DRUGS LTD CEFIXIME
### I II 1/21/2010 SEQUENT SCIENTIFIC LTD TENOFOVIR DISOPROXIL FUMARATE
### I II 2/20/2010 UNIMARK REMEDIES LTD ESZOPICLONE
### A II 1/18/2010 CAMBREX PROFARMACO MILANO SRL SODIUM PICOSULFATE
### A II 1/22/2010 CYALUME SPECIALTY PRODUCTS INC DEXTROMETHORPHAN TANNATE
### A II 1/22/2010 SHILPA MEDICARE LTD TEMOZOLOMIDE USP
### A II 1/26/2010 INDUSTRIALE CHIMICA SRL BIMATOPROST
### A IV 1/20/2010 UNGERER AND CO ARTIFICIAL TUTTI FRUITTI FLAVOR FS-6943
### A II 1/26/2010 CYALUME SPECIALTY PRODUCTS INC PSEUDOEPHEDRINE TANNATE
### A III 12/26/2009 PACKNOWCRAT INDIA PVT LTD FLEXIBLE PACKAGING MATERIAL
### I II 5/7/2010 NEKTAR THERAPEUTICS N-HYDROXYSUCCINIMIDYL ESTER OF BIS
(METHOXYPOLY(ETHYLENE GLYCOL) MW
20,000) MODIFIED LYSINE
### A II 2/7/2010 BGP HEALTHCARE PRIVATE LTD NICOTINE USP
### I II 1/27/2010 HAINAN POLY PHARMACEUTICAL CO AZITHROMYCIN GRANULES FOR ORAL
LTD SUSPENSION
Page 743
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 1/27/2010 HAINAN POLY PHARMACEUTICAL CO GLUCOSAMINE HYDROCHLORIDE PELLETS
LTD CAPSULES
### A II 1/27/2010 MSN LABORATORIES PRIVATE LTD PITAVASTATIN CALCIUM [ROUTE CODE: PC]
### A III 1/21/2010 HYUNDAI ENGINEERING PLASTICS CO PACKAGING MATERIAL
LTD
### I II 1/28/2010 APOTEX PHARMACHEM INC LUBIPROSTONE
### A II 1/22/2010 ZHEJIANG HUAHAI PHARMACEUTICAL VALSARTAN USP (PROCESS II)
CO LTD
### A III 1/20/2010 PRETIUM PACKAGING LLC PLASTIC PACKAGING MATERIAL
### I II 1/22/2010 HUBEI HAOSUN PHARMACEUTICAL CO AMISULPRIDE
LTD
### I II 4/30/2010 FIS FABBRICA ITALIANA SINTETICI SPA DUTASTERIDE
### A II 1/29/2010 APOTEX PHARMACHEM INC MONTELUKAST SODIUM USP
### A II 1/29/2010 SANOFI CHIMIE CABAZITAXEL ACETONE SOLVATE
### A III 1/22/2010 LG CHEM LTD PP PRODUCTS
### A III 1/22/2010 LG CHEM LTD LDPE PRODUCTS
### A III 2/1/2010 KLOCKNER PENTAPLAST POLYESTER BASED PACKAGING FILMS
### A II 2/16/2010 UNIMARK REMEDIES LTD NITROFURANTOIN ANHYDROUS USP
### A II 2/16/2010 UNIMARK REMEDIES LTD NITROFURANTOIN MONOHYDRATE USP
### A II 5/6/2010 TARO PHARMACEUTICAL INDUSTRIES MOMETASONE FUROATE USP/PH EUR
LTD MICRONIZED
### A II 1/22/2010 CALYX CHEMICALS AND FLUCYTOSINE
PHARMACEUTICALS LTD
### A IV 2/1/2010 BASF SE SOLUPLUS
### A III 1/26/2010 KISHORE PHARMA PRODUCTS PVT LTD I GLASS AMPOULES AND VIALS
### A II 2/2/2010 TEVA PHARMACEUTICAL INDUSTRIES PACLITAXEL SEMISYNTHETIC
LTD
### I II 1/27/2010 AREVIPHARMA GMBH FLUTAMIDE
### I II 1/16/2010 QILU PHARMACEUTICAL CO LTD EXEMESTANE (NON STERILE API)
### A II 2/2/2010 RAKS PHARMA PVT LTD SILDENAFIL CITRATE USP
### A II 4/21/2010 PRONOVA BIOPHARMA NORGE AS OMEGA-3 ACID ETHYL ESTERS 78
23511 A II 1/22/2010 SUPRIYA LIFESCIENCE LTD BROMPHENIRAMINE MALEATE
### A II 1/22/2010 SUPRIYA LIFESCIENCE LTD PHENIRAMINE MALEATE
### A II 2/18/2010 USV PRIVATE LTD ATOVAQUONE USP (FORM III)
### I III 2/2/2010 IFS INDUSTRIES INC IFS HOT MELT #M-766-2V (HM-560)
### A III 1/29/2010 BASELL POLIOLEFINE ITALIA SRL PURELL PE 3420 F
### I II 2/12/2010 EUTICALS SPA GEMCITABINE HYDROCHLORIDE
### I IV 2/8/2010 FONA INTERNATIONAL INC PRODUCT # 825.744 CHERRY FLAVOR
ARTIFICIAL
### I IV 2/9/2010 FONA INTERNATIONAL INC PRODUCT # 877.0131U N-C MINT FLAVOR NAT
WONF
### A II 2/8/2010 BIOCON LTD MYCOPHENOLATE SODIUM
### A II 2/4/2010 SIEGFRIED USA LLC OXYCODONE HYDROCHLORIDE USP
### A II 2/5/2010 DERIVADOS QUIMICOS SAU CYCLOBENZAPRINE HYDROCHLORIDE
Page 744
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 1/10/2010 HUBEI HAOSUN PHARMACEUTICAL CO IRINOTECAN HYDROCHLORIDE
LTD
### A II 2/12/2010 NATCO PHARMA LTD LANSOPRAZOLE
### A II 2/11/2010 SHENZHEN HAIBIN PHARMACEUTICAL MEROPENEM STERILE
CO LTD
### A II 2/3/2010 AUROBINDO PHARMA LTD OLANZAPINE USP (NON-STERILE DRUG
SUBSTANCE)
### A III 1/27/2010 CCC PLASTICS CANADA COLORS AND WHITE MB50-9576 POLYPROPYLENE COLOUR
CHEMICALS LTD CONCENTRATE
### A III 1/14/2010 KEJARIWAL INDUSTRIES GLASS AMPOULES AND VIALS
### A II 2/11/2010 OLAINFARM JSC AMANTADINE HYDROCHLORIDE
### A IV 2/15/2010 EMERSON RESOURCES INC PLASACRYL (R) T20
### A II 2/8/2010 QILU PHARMACEUTICAL CO LTD OXALIPLATIN USP (NON-STERILE API)
### A V 2/4/2010 BASF SE KOLLIPHOR HS 15 PRE-CLINICAL SAFETY DATA
### A II 1/29/2010 FERMION OY METHOTREXATE DISODIUM
### A II 2/16/2010 MSN LABORATORIES PRIVATE LTD DUTASTERIDE USP [ROUTE CODE - "DT"]
### I III 2/3/2010 APTAR RADOLFZELL GMBH POWDER DISPENSING DEVICES
### I II 1/31/2010 ALP PHARM BEIJING CO LTD URSODEOXYCHOLIC ACID (DRUG SUBSTANCE
NON-STERILE)
### I II 1/30/2010 ALP PHARM BEIJING CO LTD ADAPALENE (DRUG SUBTANCE NON-STERILE)
### A II 2/4/2010 SCI PHARMTECH INC PROPAFENONE HYDROCHLORIDE
### A III 1/13/2010 PRADEEP LAMINATORS PVT LTD RETORT POUCHES
### A II 2/13/2010 LAURUS LABS LTD LATANOPROST USP
### A II 2/19/2010 TEVA PHARMACEUTICAL INDUSTRIES FENOFIBRATE CHOLINE
LTD
### A II 4/7/2010 LUPIN LTD EZETIMIBE
### A II 3/31/2010 LUPIN LTD RITONAVIR USP
### A II 4/8/2010 LUPIN LTD CELECOXIB USP
### A II 4/15/2010 LUPIN LTD CEFDITOREN PIVOXIL
### I II 3/16/2010 USV LTD BEXAROTENE
### A II 2/17/2010 CHEMWERTH INC TEMOZOLOMIDE (NON-STERILE BULK DRUG
SUBSTANCE)
### A III 2/19/2010 OKADA SHIGYO CO LTD HI-GAL FILM - SEIBOU PE-01
### I III 2/17/2010 AMPACET CORP 182136 BEIGE PP MB
### A III 2/19/2010 EI DUPONT DE NEMOURS AND CO INC DUPONT ELVALOY AC RESINS
### I III 11/8/2009 REGO PACKING INDUSTRY CO LTD COLLAPSIBLE LAMINATED TUBES FOR
PHARMACEUTICAL PACKAGING
### A II 4/8/2010 LUPIN LTD GATIFLOXACIN
### A II 3/8/2010 SUN PHARMACEUTICAL INDUSTRIES TEMOZOLOMIDE USP
LTD
### A II 2/21/2010 WAVELENGTH ENTERPRISES LTD CISATRACURIUM BESYLATE
### A II 3/9/2010 USV PRIVATE LTD ATOVAQUONE USP (FORM I)
### I II 2/16/2010 SPECIALTY ENZYMES AND SERRATIOPEPTIDASE
BIOCHEMICALS CO
Page 745
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 2/19/2010 FUJIAN SOUTH PHARMACEUTICAL CO PACLITAXEL (NATURAL) USP (NATURAL, NON-
LTD STERILE BULK DRUG SUBSTANCE)
### A II 2/12/2010 ARKEMA INC LUPEROX A75FP
### I II 2/19/2010 HUBEI MEIKAI CHEMICAL CO LTD OXYBENZONE
### A II 2/22/2010 SOLARA A PHARMA SCIENCES LTD LUMEFANTRINE
### A II 2/23/2010 SHILPA MEDICARE LTD IRINOTECAN HYDROCHLORIDE TRIHYDRATE
USP
### A II 2/23/2010 SHILPA MEDICARE LTD OXALIPLATIN USP
### A II 2/23/2010 DR REDDYS LABORATORIES LTD AZACITIDINE
### I III 2/18/2010 AMPACET CORP 15571 PINK AS PE MB
### A II 3/3/2010 ARCH PHARMALABS LTD CITALOPRAM HYDROBROMIDE USP (CYANO
ROUTE)
### A II 2/22/2010 HIKAL LTD MEMANTINE HYDROCHLORIDE USP
### A III 2/22/2010 LABLABO METERED AEROSOL VALVES
### I II 2/24/2010 DR REDDYS LABORATORIES LTD RILUZOLE
### A II 3/12/2010 UNIMARK REMEDIES LTD NITROFURANTOIN ANHYDROUS CRYSTALS USP
Page 754
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 6/2/2010 ZHEJIANG HUAHAI PHARMACEUTICAL LEVETIRACETAM USP (PROCESS II)
CO LTD
### A II 6/2/2010 HETERO LABS LTD DARUNAVIR AMORPHOUS
### A II 6/3/2010 HARMAN FINOCHEM LTD FENOFIBRIC ACID
### A II 5/27/2010 PRODUCTOS QUIMICOS NATURALES SA 17 ALPHA-ESTRADIOL
DE CV
### I III 5/19/2010 INGENIA POLYMERS CORP INGENIA POLYMERS 1020 FILLED WHITE FOR
USE IN PACKAGING MATERIALS
### A II 5/28/2010 ZHUHAI UNITED LABORATORIES CO LTD MEROPENEM CRUDE NON- STERILE
### A II 5/27/2010 MYLAN LABORATORIES LTD VALGANCICLOVIR HYDROCHLORIDE USP
(AMORPHOUS)
### A II 6/4/2010 CADILA HEALTHCARE LTD BENZOYL PEROXIDE HYDROUS USP
### I IV 6/4/2010 FONA INTERNATIONAL INC 805.219 BANANA FLAVOR, NAT WONF
### I II 5/20/2010 ST GOBAIN PERFORMANCE PLASTICS TYGON 3350 SILICONE TUBING
CORP
### A II 6/28/2010 APICORE US LLC FONDAPARINUX SODIUM USP
### A II 6/3/2010 MSN PHARMACHEM PRIVATE LTD SITAGLIPTIN PHOSPHATE MONOHYDRATE USP
(ROUTE CODE SG)
### A II 6/7/2010 HETERO DRUGS LTD LEVOFLOXACIN HEMIHYDRATE, USP
### A II 6/28/2010 ORCHID PHARMA LTD ISA (INTERMEDIATE)
### A II 6/4/2010 EUTICALS SPA SODIUM MYCOPHENOLATE
### A IV 6/7/2010 XIANGSHAN JINAN IMPORT AND HARD EMPTY GELATIN CAPSULES
EXPORT CO LTD
### A II 7/20/2010 TRIS PHARMA INC METHYLPHENIDATE ERL (METHYLPHENIDATE
ER POWDER FOR ORAL SUSPENSION)
### A II 11/29/2010 CADILA PHARMACEUTICALS LTD PALIPERIDONE USP
### I II 6/10/2010 YUNG SHIN PHARMACEUTICAL CEPHALEXIN USP "YUNG SHIN"
INDUSTRIAL CO LTD
### A II 6/10/2010 MYLAN LABORATORIES LTD DARUNAVIR
### A IV 6/9/2010 EVONIK NUTRITION AND CARE GMBH RESOMER® SR FOR PHARMACEUTICAL
APPLICATIONS
### A II 6/9/2010 TEVA PHARMACEUTICAL INDUSTRIES FLUOCINOLONE ACETONIDE - PROCESS II
LTD
### A II 5/31/2010 BIOTIKA AS POLYMYXIN B SULFATE
### I II 5/31/2010 AREVIPHARMA GMBH METAXALONE
### A II 5/31/2010 BIA SEPARATIONS DOO CIM CONVECTIVE INTERACTION MEDIA SO3
### A II 6/5/2010 NUVIEW LIFE SCIENCES INC SODIUM IODINE (I-123) DRY IODINE
RADIOCHEMICAL
### A II 6/9/2010 CENTAUR PHARMACEUTICALS PVT LTD BRIMONIDINE TARTRATE USP
### A II 6/29/2010 TORRENT PHARMACEUTICALS LTD PALIPERIDONE
### A IV 6/9/2010 UNGERER AND CO NATURAL AND ARTIFICIAL ORANGE FLVP FO-
9464
### A II 8/4/2010 SPECGX LLC OPIUM TINCTURE 2%
### A II 6/8/2010 INDENA SPA N-DEBOC-DOCETAXEL (N-DEBENZOYL-10-
DEACETYLPACLITAXEL INTERMEDIATE)
Page 755
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 4/29/2010 MELODY HEALTHCARE PVT LTD RAMIPRIL
### A II 8/30/2010 INDENA SPA DOCETAXEL
### I II 6/15/2010 SEQUENT SCIENTIFIC LTD PRAZIQUANTEL
### A II 6/8/2010 WAVELENGTH ENTERPRISES LTD MOMETASONE FUROATE MONOHYDRATE
### A II 6/15/2010 MSN PHARMACHEM PRIVATE LTD OSELTAMIVIR PHOSPHATE [ROUTE CODE - "OT"]
Page 761
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 6/18/2010 WINPAK HEAT SEAL PACKAGING INC FLEXIBLE PACKAGING MATERIALS FOR
POUCH/SACHET PACKAGING
### A II 8/23/2010 MSN PHARMACHEM PRIVATE LTD ARIPIPRAZOLE USP [ROUTE CODE - "AL1"]
### A II 8/20/2010 PHARMATHEN INDUSTRIAL SA FLUVASTATIN SODIUM AMORPHOUS
### A IV 8/16/2010 3M DRUG DELIVERY SYSTEMS SOLVATED ACRYLATE COPOLYMER ADHESIVE
R-27171
### I II 8/17/2010 3M DRUG DELIVERY SYSTEMS DIV RESIQUIMOD TOPICAL GEL
### A IV 8/23/2010 DAVID MICHAEL AND CO INC MICHAELOK® NATURAL LEMON FLAVOR #676
### A III 8/2/2010 STELLA KUNSTSTOFFTECHNIK GMBH STELLA SCREW-NECK BOTTLE SECRO PP28
AND STELLA PROTECAP PP28
### A II 8/12/2010 CTX LIFE SCIENCES PVT LTD CARVEDILOL (ROUTE-II)
### A III 8/24/2010 ASSEM PAK INC ELASTOMERIC STOPPERS AND CLOSURES
### A II 9/2/2010 UNICHEM LABORATORIES LTD ARIPIPRAZOLE USP
### A IV 8/27/2010 SPI PHARMA INC PHARMABURST® 500 AND SL SERIES
### A II 8/26/2010 VENKATA NARAYANA A INGREDIENTS TETRACAINE USP
PRIVATE LTD
### A III 8/24/2010 CONSOLIDATED BOTTLE CORP 3/4 X 2 NATURAL PP VIAL PRINTED WITH LINE
### A III 8/24/2010 CONSOLIDATED BOTTLE CORP 1 INCH WHITE SMOOTH TOP PE CAP PLUG
FINISH
### A III 8/24/2010 CONSOLIDATED BOTTLE CORP 1 INCH X 2 INCH NATURAL PP VIAL PRINTED
WITH LINE
### A III 8/24/2010 CONSOLIDATED BOTTLE CORP ¾" WHITE SMOOTH TOP PE CAP PLUG FINISH
### A III 7/21/2010 BESPAK CONSORT MEDICAL PLC BK357 & BK361 VALVE EXTRACTABLES
INFORMATION
### A II 8/27/2010 INDOCO REMEDIES LTD OLOPATADINE HYDROCHLORIDE USP
### A II 8/31/2010 DIPHARMA FRANCIS SRL GLYCERYL TRINITRATE SOLUTION
### A II 8/31/2010 DAIWA PHARMACEUTICAL CO LTD LOXOPROFEN SODIUM HYDRATE
### A III 8/20/2010 APTAR FRANCE SAS UNIT DOSE AND BIDOSE SYSTEMS
24110 A II 8/30/2010 MACLEODS PHARMACEUTICALS LTD CLOPIDOGREL BISULFATE USP
24111 A IV 8/25/2010 ABELEI INC 113a61 NATURAL & ARTIFICIAL BERRY FLAVOR
24112 I II 8/31/2010 PHARMAZELL DENMARK AS TERBINAFINE AS TERBINAFINE
HYDROCHLORIDE
24113 A III 8/31/2010 HB FULLER CO ADHESIVE USED IN PLASTIC CLOSURE
SYSTEMS
24114 A II 8/30/2010 GULBRANDSEN TECHNOLOGIES INC ACHIEVE L 5440 PG SOLUTION
24115 I III 6/21/2010 PLASTIAPE SPA DESICCANT CAP AND PILL JAR
24116 A II 9/27/2010 AUROBINDO PHARMA LTD ATORVASTATIN CALCIUM (AMORPHOUS)
24117 I II 11/12/2010 XOMA US LLC XOMA 3AB
24118 A II 9/1/2010 ZHEJIANG JINHUA CONBA BIO PHARM OMEPRAZOLE
CO LTD
24119 I II 12/28/2010 IPCA LABORATORIES LTD ZOLEDRONIC ACID
### I II 12/9/2010 IPCA LABORATORIES LTD BISOPROLOL FUMARATE USP
### I II 12/15/2010 IPCA LABORATORIES LTD CITALOPRAM HYDROBROMIDE USP
Page 762
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 8/30/2010 PFANSTIEHL INC ALPHA, ALPHA-TREHALOSE DIHYDRATE, HIGH
PURITY (LOW ENDOTOXIN), USP/NF, EP, JP (T-
104-4)
### A II 9/1/2010 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [0775279]
### A II 9/9/2010 GLENMARK PHARMACEUTICALS LTD BOSENTAN
### I V 8/25/2010 JANSSEN DIAGNOSTICS BVBA GENOTYPIC RESISTANCE TESTING FOR HCV AS
LOCATED IN BEERSE, BELGIUM
### A II 8/31/2010 SCINOPHARM TAIWAN LTD CAPECITABINE
### A II 9/3/2010 IRVINE SCIENTIFIC SALES CO INC FMDF-11 (KIRIN)
### I II 8/31/2010 RPG LIFE SCIENCES LTD DOXORUBICIN HYDROCHLORIDE USP/EP
### A II 9/2/2010 TEVA PHARMACEUTICAL INDUSTRIES MYCOPHENOLATE SODIUM
LTD
### I II 8/30/2010 ZHEJIANG JIUZHOU PHARMACEUTICAL CLOPIDOGREL BISULFATE
CO LTD
### A III 10/18/2010 HOSPIRA INC ABBOJECT™ SYRINGE SYSTEM
### A III 8/30/2010 AMPACET CORP 103177 SLIP PP MB
### A II 8/19/2010 QILU PHARMACEUTICAL CO LTD IRINOTECAN HYDROCHLORIDE (NON STERILE,
API)
### A II 8/31/2010 NECTAR LIFESCIENCES LTD CEFTRIAXONE SODIUM (NON-STERILE) DRUG
SUBSTANCE
### A II 8/16/2010 VITAL LABORATORIES PVT LTD DIGOXIN
### A II 3/4/2011 SHILPA MEDICARE LTD GEMCITABINE HYDROCHLORIDE USP
### A III 9/3/2010 RELIANCE INDUSTRIES LTD RELENE 1070LA17
### A IV 9/6/2010 LIPOID GMBH LIPOID E 100, LIPOID E PC S, LIPOID E PC
### A II 9/7/2010 SUN PHARMACEUTICAL INDUSTRIES ATORVASTATIN CALCIUM TRIHYDRATE USP
LTD
### I III 6/8/2010 ROHM AND HAAS CO PARALOID RESINS USED AS A COMPONENT IN
PHARMACEUTICAL PACKAGING
### I IV 9/14/2010 KERRY BIOFUNCTIONAL INGREDIENTS LUBRITOSE SD
INC DBA KERRY BIO SCIENCE
### I IV 9/14/2010 KERRY BIOFUNCTIONAL INGREDIENTS LUBRITOSE MCC
INC DBA KERRY BIO SCIENCE
### I IV 9/14/2010 KERRY BIOFUNCTIONAL INGREDIENTS 5X00255 SHEFFCOAT CLEAR GL
INC DBA KERRY BIO SCIENCE
### I IV 9/14/2010 KERRY BIOFUNCTIONAL INGREDIENTS 5X00282 SHEFFCOAT CLEAR 02
INC DBA KERRY BIO SCIENCE
### I II 9/23/2010 USV LTD DOLASETRON MESYLATE USP
### A III 6/23/2010 FUJIMORI KOGYO CO LTD PLASTIC FILMS FOR USE IN DRUG PRODUCT
CONTAINER
### A II 7/27/2010 CATALENT MICRON TECHNOLOGIES INC MICRONIZATION PROCESS FACILITY
Page 763
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 8/13/2010 DDP SPECIALTY ELECTRONIC DOW CORNING™ DIMETHICONOL BLEND 20
MATERIALS US 9 LLC
### A II 8/28/2010 ZHEJIANG CHARIOTEER ADEFOVIR DIPIVOXIL DMC (ADVANCE
PHARMACEUTICAL CO LTD INTERMEDIATE)
### A II 8/1/2010 SERATEC SAS METHYLDOPATE HYDROCHLORIDE USP
### A II 9/10/2010 MACLEODS PHARMACEUTICALS LTD RIVASTIGMINE TARTRATE
### A II 9/10/2010 INTERQUIM SA SOLIFENACIN SUCCINATE
### A II 9/9/2010 ALKALOIDS CORP COLCHICINE USP (REFINED GRADE)
### I V 11/24/2010 XOMA US LLC NONCLINICAL (PHARMACOLOGY,
PHARMACOKINETICS, AND TOXICOLOGY) FOR
XOMA 3AB
### A II 1/27/2011 SPECGX LLC NOSCAPINE USP/EP CRYSTALS CODE 6047
### I III 3/29/2011 SCHOTT NORTH AMERICA INC SYRIQ PREFILLABLE GLASS SYRINGES
### A II 9/1/2010 TAI HENG INDUSTRY CO LTD RASAGILINE MESYLATE
### A II 8/31/2010 CSPC ZHONGNUO PHARMACEUTICAL CEFTRIAXONE SODIUM (NON-STERILE)
SHIJIAZHUANG CO LTD
### I II 8/29/2010 WAVELENGTH ENTERPRISES LTD LEVOCETIRIZINE DIHYDROCHLORIDE
### I II 9/7/2010 DISHMAN PHARMACEUTICALS AND HEXETIDINE
CHEMICALS LTD
### A II 9/24/2010 GLENMARK PHARMACEUTICALS LTD PALIPERIDONE
### A III 8/19/2010 ALPHAPOINTE POLYPROPYLENE PLASTIC BOTTLES USED FOR
ORAL MEDICATION
### A III 8/19/2010 ALPHAPOINTE ASSN FOR THE BLIND HIGH DENSITY POLYETHYLENE PLASTIC
BOTTLES USED FOR ORAL MEDICATION
### A IV 9/10/2010 UNGERER AND CO NATURAL MELON WONF FLAVOR #14747
### I III 9/14/2010 PPG INDUSTRIES INC PPG PACKAGING PPG4553-603 COATING
AND COATINGS
### I II 9/15/2010 3D IMAGING DRUG DESIGN AND [F-18] FDPN
DEVELOPMENT LLC
### I III 9/14/2010 PPG INDUSTRIES INC PPG PACKAGING P-2238862 COATING
AND COATINGS
### I III 9/14/2010 PPG INDUSTRIES INC PPG PACKAGING PPG4553-303 COATING
AND COATINGS
### A III 9/10/2010 HUDSON COLOR CONCENTRATES WHITE HC81523PVC
### A III 9/14/2010 AMERICAS STYRENICS LLC HIGH IMPACT POLYSTYRENE (HIPS) RESINS
### A II 8/6/2010 GLOPEC INTERNATIONAL INC TEMOZOLOMIDE
### I II 8/7/2010 SMRUTHI ORGANICS LTD S (-) AMLODIPINE BESILATE USP
### A II 9/13/2010 JIANGSU HENGRUI MEDICINE CO LTD DOCETAXEL TRIHYDRATE USP
### I II 10/6/2010 ZHEJIANG XIANJU JUNYE NORETHINDRONE
PHARMACEUTICAL CO LTD
### A II 9/27/2010 UNIMARK REMEDIES LTD RIZATRIPTAN BENZOATE
### A II 9/13/2010 MACLEODS PHARMACEUTICALS LTD VALSARTAN
### A II 9/14/2010 SOLARA A PHARMA SCIENCES LTD KETOPROFEN USP
### A II 9/29/2010 TORRENT PHARMACEUTICALS LTD OLMESARTAN MEDOXOMIL USP
Page 764
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 9/15/2010 MSN ORGANICS PRIVATE LTD PIOGLITAZONE HYDROCHLORIDE USP [ROUTE
CODE "PG"]
### I II 9/15/2010 ELAN DRUG DELIVERY INC N1766 TABLETS
### A II 9/15/2010 DIVIS LABORATORIES LTD TRITYL LOSARTAN
### I IV 9/13/2010 POLYDRUG LABORATORIES PVT LTD FERROUS FUMARATE
### A II 9/17/2010 CHONGQING DAXIN PHARMACEUTICAL VANCOMYCIN HYDROCHLORIDE
CO LTD
### A II 9/10/2010 MEGAFINE PHARMA P LTD SOLIFENACIN SUCCINATE
### A IV 9/16/2010 HENKEL CORP DURO-TAK(TM) 87-624A PRESSURE SENSITIVE
ADHESIVE
### A II 9/27/2010 AUROBINDO PHARMA LTD ENTACAPONE USP (NON-STERILE DRUG
SUBSTANCE)
### A II 9/20/2010 FORMOSA LABORATORIES INC ERGOCALCIFEROL
### A III 11/9/2010 AERO PUMP GMBH PUMP SYSTEMS FOR ORAL AND TOPIC
APPLICATIONS
### A II 9/16/2010 VANTAGE SPECIALTY INGREDIENTS CUROXYL® 42
### I II 10/6/2010 ZHEJIANG XIANJU JUNYE ESTRADIOL
PHARMACEUTICAL CO LTD
### A II 9/20/2010 RELIABLE BIOPHARMACEUTICAL LLC CYANOMETHYL MANNOSYL ACETATE
### I II 9/20/2010 KINGLAND CHEMICALS CO LTD BENZONATATE
### A II 9/17/2010 CTX LIFE SCIENCES PVT LTD CARBAMAZEPINE USP
### A II 9/21/2010 OLON SPA PREGABALIN
### I II 9/21/2010 NATIONAL JEWISH HEALTH FBC-0007 (Mn-Te-2PyP)
### A II 9/21/2010 ACS DOBFAR SPA GENTAMICIN SULFATE
### A II 10/9/2010 SUN PHARMACEUTICAL INDUSTRIES SITAGLIPTIN PHOSPHATE USP
LTD
### A II 10/28/2010 JUBILANT GENERICS LTD LEVETIRACETAM USP
### I II 9/25/2010 QILU PHARMACEUTICAL CO LTD CARBOPLATIN PROCESS II
### A II 12/15/2011 CHEMWERTH INC DEXMEDETOMIDINE HCL
### I II 8/26/2010 HAINAN POLY PHARMACEUTICAL CO TRIMEBUTINE MALEATE DRUG SUBSTANCE
LTD
### I III 9/23/2010 SK CHEMICALS CO LTD SKYPET BR
### A II 9/22/2010 DERIVADOS QUIMICOS SAU MELOXICAM
### A II 9/28/2010 SMS PHARMACEUTICALS LTD TADALAFIL
### A II 3/4/2011 RELIANCE LIFE SCIENCES PVT LTD IMATINIB MESYLATE
### I II 9/28/2010 MYLAN LABORATORIES LTD LATANOPROST
### A II 10/28/2010 GLENMARK PHARMACEUTICALS LTD DEFERASIROX
### I II 9/24/2010 JIANGXI SYNERGY PHARMACEUTICAL ACECLOFENAC
CO LTD
24211 I II 9/24/2010 JIANGXI SYNERGY PHARMACEUTICAL TELMISARTAN
CO LTD
### A IV 9/24/2010 HENRY H OTTENS MANUFACTURING CO ARTIFICIAL BUTTERSCOTCH FLAVOR
INC CONCENTRATE #5659
### A II 9/30/2010 CEDARBURG PHARMACEUTICALS INC BRIMONIDINE TARTRATE
### I III 9/27/2010 FLEXTRUS AB TRANSOFOIL EL-OPET/I
Page 765
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 9/22/2010 SYMBIOTICA SPECIALITY INGREDIENTS DEXAMETHASONE SODIUM PHOSPHATE
SDN BHD
### A II 9/17/2010 PRODUCTOS QUIMICOS NATURALES SA PRASTERONE (DEHYDROEPIANDROSTERONE)
DE CV PROQUINA
### A III 9/30/2010 BAXTER HEALTHCARE CORP CLARITY CONTAINER CLOSURE SYSTEM
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-LIGHT BLUE PP52176043
AB
### I III 9/17/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-WHITE PP00176011
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-MID GREY PP7M 176017
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN REMAFIN-BROWN PP83176012
AB
### I III 9/17/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-RED PP3M176028
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-ORANGE PE2M176044
AB
### I III 9/17/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-BLACK PP9M176008
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-BEIGE PE8M176048
AB
### I III 9/21/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-BLUISH GREEN PE6M176126
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-BROWN PE8M176049
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-DARK BLUE PE5M176153
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-DARK BLUE PP5M176045
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-LIGHT BLUE PE 5
AB
### I III 9/21/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-LIGHT GREEN PE6M176
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN REMAFIN-MID BLUE PE52176154
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-MID BLUE PP5M176044
AB
### I III 9/21/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-MID GREEN PE6M176127
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-MID GREEN PP6M176028
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-RED PE3M176131
AB
### I III 9/21/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-VIOLET PE4M176023
AB
Page 766
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-MID GREY PE7M176067
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-WHITE PEOM176031
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-MID YELLOW PE1M176076
AB
### I III 9/17/2010 CLARIANT MASTERBATCHES NORDEN REMAFIN-YELLOW PP13176012
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN REMAFIN-DARK GREY PE74176066
AB
### I III 9/17/2010 CLARIANT MASTERBATCHES NORDEN REMAFIN-PINK PP32176027
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN REMAFIN-VIOLET PP43176005
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN REMAFIN-BLUISH GREEN PP63176029
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN REMAFIN-BEIGE PP82176011
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN REMAFIN-BLACK PL94176008
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN REMAFIN-DARK GREY PP74176018
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN REMAFIN-LIGHT GREEN PP62176027
AB
### I III 9/20/2010 CLARIANT MASTERBATCHES NORDEN REMAFIN-PINK PE32176130
AB
### I III 9/17/2010 CLARIANT MASTERBATCHES NORDEN REMAFIN-ORANGE PP23176008
AB
### I III 9/22/2010 HRJ SURGICALS PLASTIC ITEMS USED AS PRIMARY PACKAGING
MATERIAL IN PHARMACEUTICAL PRODUCTS
### I II 9/24/2010 GULBRANDSEN TECHNOLOGIES INC ACHIEVE L 5440 PG SOLUTION
### A II 8/25/2010 LABORATORIO OPOTERAPICO CHONDROITIN SULFATE POWDER
ARGENTINO SA
### I II 9/10/2010 ALP PHARM BEIJING CO LTD CICLESONIDE
### A II 9/10/2010 ALP PHARM BEIJING CO LTD MESALAMINE
### A II 9/15/2010 ALP PHARM BEIJING CO LTD BIVALIRUDIN
### I III 10/1/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-TRANS RED PP3M176042
AB
### I III 10/1/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-TRANS YELLOW PP1M176018
AB
### I III 10/1/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-TRANS GREY PP7M176029
AB
### I III 10/1/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-TRANS BLUE PP5M176061
AB
Page 767
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 10/1/2010 CLARIANT MASTERBATCHES NORDEN MEVOPUR-TRANS GREEN PP6M176048
AB
### A II 10/6/2010 AMINO CHEMICALS LTD PALIPERIDONE USP
### A II 12/2/2010 APICORE US LLC LENALIDOMIDE
### A IV 10/4/2010 PRODOTTI CHIMICI E ALIMENTARI SPA GLYCOCHOLIC ACID
### A II 10/8/2010 APOTEX PHARMACHEM INC SITAGLIPTIN PHOSPHATE MONOHYDRATE USP
### I III 9/29/2010 CODING PRODUCTS SV-17807
### A III 9/29/2010 CODING PRODUCTS SV-14207
### A III 9/29/2010 CODING PRODUCTS SV-19820
### A III 9/29/2010 CODING PRODUCTS SV-17383
### A III 8/13/2010 SARONG EMPTY SUPPOSITORY SHELLS OF
POLYVINYLCHLORIDE/POLYETHYLENE FILM
LAMINATE
### I II 10/13/2010 PROTEUS SA NEOSAXITOXIN
### I II 10/13/2010 CADILA HEALTHCARE LTD DULOXETINE HYDROCHLORIDE USP (DUB
ROUTE)
### A II 12/14/2010 TARO PHARMACEUTICAL INDUSTRIES DESLORATADINE
LTD
### I III 9/20/2010 HMC POLYMERS CO LTD PURELL RP270M
### A II 10/14/2010 ALEMBIC PHARMACEUTICALS LTD FENOFIBRIC ACID
### I II 10/14/2010 PHARMAESSENTIA CORP GEMCITABINE HYDROCHLORIDE
### A III 10/7/2010 APTAR FRANCE SAS LATITUDE™ SIDE ACTUATION DEVICE
### A III 9/20/2010 POLYONE CORP CC10132659BG
### A III 9/20/2010 POLYONE CORP CC10132662BG
### A III 9/20/2010 POLYONE CORP CC00017726WE
### A III 9/20/2010 POLYONE CORP CC00017835WE
### A III 9/20/2010 POLYONE CORP CC10012890WE
### A II 10/29/2010 AUROBINDO PHARMA LTD TRAMADOL HYDROCHLORIDE USP (NON
STERILE DRUG SUBSTANCE)
### I II 11/8/2010 FIS FABBRICA ITALIANA SINTETICI SPA LUBIPROSTONE
### I II 12/9/2010 PHF SA IMATINIB MESYLATE
### A II 11/1/2010 USV PRIVATE LTD OCTREOTIDE ACETATE USP
### A II 10/15/2010 SOLARA A PHARMA SCIENCES LTD ACYCLOVIR SODIUM
### I II 10/9/2010 QILU PHARMACEUTICAL CO LTD RISPERIDONE (NON STERILE, API)
### A II 9/28/2010 JOHNSON MATTHEY PHARMACEUTICAL MORPHINE TECHNICAL ALKALOID
MATERIALS
### A II 9/30/2010 ALEMBIC PHARMACEUTICALS LTD PREGABALIN USP
### A IV 10/15/2010 ABELEI INC 148A84 NATURAL AND ARTIFICIAL GRAPEFRUIT
ORANGE FLAVOR
### A IV 10/15/2010 ABELEI INC 196A22 NATURAL AND ARTIFICIAL JUICY FRUIT
FLAVOR
### A IV 10/15/2010 ABELEI INC 174A78 NATURAL AND ARTIFICIAL MINT FLAVOR
### A II 11/4/2010 AUROBINDO PHARMA LTD CANDESARTAN CILEXETIL (NON STERILE DRUG
SUBSTANCE)
### A II 10/29/2010 IND SWIFT LABORATORIES LTD CINACALCET HYDROCHLORIDE
Page 768
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/17/2010 IND SWIFT LABORATORIES LTD TEMOZOLOMIDE USP
### A III 10/8/2010 TEKNOR COLOR CO 32,820HCC AMBER 50:1
### A III 10/7/2010 ROCHLING MEDICAL NEUHAUS GMBH INJECTION BOTTLES WITH CLINCH NECK FINISH
AND CO KG
### A III 10/9/2010 TEKNOR APEX CO MEDALIST® MD-585 NATURAL
### A III 10/9/2010 TEKNOR APEX CO MEDALIST® MD-565 NATURAL
### A III 10/9/2010 TEKNOR APEX CO MEDALIST® MD-575 NAT
### A II 10/19/2010 CATALENT PHARMA SOLUTIONS LLC DUTASTERIDE 0.5 MG SOFT GELATIN CAPSULES
### A III 12/22/2010 BESPAK CONSORT MEDICAL PLC BK357 AND BK361 VALVE SPECIFIC
INFORMATION
### A II 12/23/2010 MYLAN LABORATORIES LTD RIVASTIGMINE
### A II 10/12/2010 SYMBIOTICA SPECIALITY INGREDIENTS BETAMETHASONE DIPROPIONATE
SDN BHD
### A II 12/23/2010 CHEMO IBERICA SA LANSOPRAZOLE USP
### A IV 12/22/2010 3M DRUG DELIVERY SYSTEMS SOLVATED ACRYLATE COPOLYMER ADHESIVE
R-24449
### A III 12/23/2010 BORMIOLI PHARMA SPA OVERTUNING DROPPER 0.65 MM
### A III 12/23/2010 BORMIOLI PHARMA SPA TAMPER EVIDENT CLOSURE 15-24 MM
### A III 12/23/2010 BORMIOLI PHARMA SPA LDPE BOTTLE 10 ML
### I IV 12/21/2010 KERRY BIOFUNCTIONAL INGREDIENTS DISINTEQUIK MCC 25
INC DBA KERRY BIO SCIENCE
### A III 12/20/2010 RENOLIT BRIGHTWOOD PHARMMED MULTILAYER FILM (518)
CONSUMABLE BJ LTD
### A III 12/21/2010 SCHOTT KAISHA PVT LTD NEUTRAL GLASS SULPHUR TREATED VIALS
Page 774
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/28/2010 COVALENT LABORATORIES PRIVATE LTD CEFUROXIME ACID (ACETONE ROUTE)
Page 775
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 1/6/2011 PAR A TECHNOLOGIES PRIVATE LTD ATORVASTATIN CALCIUM AMORPHOUS (NON-
STERILE BULK DRUG SUBSTANCE)
### A III 12/15/2010 SUZHOU HAISHUN PACKAGING PCTFE/PVC COMPOSITE SHEET FOR
MATERIAL CO LTD PHARMACEUTICAL PACKAGING
### A III 12/15/2010 SUZHOU HAISHUN PACKAGING ALUMINIUM FOIL FOR MEDICINE
MATERIAL CO LTD
### A III 12/15/2010 SUZHOU HAISHUN PACKAGING POLYAMIDE/ALUMINIUM/PVC COLD-FORMED
MATERIAL CO LTD FOIL FOR PHARMACEUTICAL PACKAGING
### A II 1/4/2011 PARABOLIC DRUGS LTD CEFUROXIME AXETIL - AMORPHOUS (PROCESS-
III) USP
### I II 1/7/2011 CADILA HEALTHCARE LTD ESOMEPRAZOLE SODIUM
### A III 12/15/2010 PAREKHPLAST INDIA LTD HDPE BOTTLES WITH CAPS
### A II 1/7/2011 MOEHS IBERICA SL CHOLINE FENOFIBRATE
### A II 1/7/2011 MOEHS IBERICA SL QUETIAPINE FUMARATE
### A II 1/31/2011 USV PRIVATE LTD OLOPATADINE HYDROCHLORIDE USP
### A II 1/7/2011 NEWCHEM SPA TRIAMCINOLONE ACETONIDE MICRONIZED
### A II 3/2/2011 AUROBINDO PHARMA LTD VALSARTAN USP (PROCESS II)
### A II 12/17/2010 SAFC INC HALOFUGINONE LACTATE
### A II 1/12/2011 UQUIFA MEXICO SA DE CV CARISOPRODOL
### A II 1/4/2011 ZHEJIANG APELOA JIAYUAN LEVALBUTEROL L-TARTRATE
PHARMACEUTICAL CO LTD
### A II 12/22/2010 ZHEJIANG HUAHAI PHARMACEUTICAL TORSEMIDE, USP
CO LTD
### A II 12/23/2010 MYLAN LABORATORIES LTD ZIDOVUDINE USP (PROCESS III)
### A III 1/5/2011 BV RUBBERFABRIEK WITTENBURG TPE W4509 THERMOPLASTIC ELASTOMER
COMPOUND FOR VIAL CAPS & CLOSURES
### A II 1/15/2011 MACLEODS PHARMACEUTICALS LTD RIZATRIPTAN BENZOATE
### I II 1/18/2011 GEDEON RICHTER PLC ESTRADIOL VALERATE
### A III 12/21/2010 GERRESHEIMER REGENSBURG GMBH GENUAIR INHALER
### I III 1/10/2011 AMPACET CORP 120919 SILVER PP MB
### I III 1/10/2011 AMPACET CORP 120937 GOLD PP MB
### A II 1/19/2011 HETERO DRUGS LTD CELECOXIB
### A V 1/10/2011 WEST PHARMACEUTICAL SERVICES INC DAIKYO CRYSTAL ZENITH (CZ) RU VIALS
Page 781
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS 58.4262.2L PHA LEMON FLAVOUR
ITALIA SPA
### A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS 20.4570.3P PHA PASSION FRUIT FLAVOUR
ITALIA SPA
### A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS 20.4564.2P PHA GRAPE FLAVOUR
ITALIA SPA
### A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS 58.3748.UW PHA PEPPERMINT FLAVOUR
ITALIA SPA
### A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS 20.4563.UL PHA CHERRY FLAVOUR
ITALIA SPA
### A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS 20.4557.1G PHA MIXED BERRIES FLAVOUR
ITALIA SPA
### A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS 58.3754.1P PHA SPEARMINT FLAVOUR
ITALIA SPA
### A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS 20.4561.1P PHA BLACKCURRANT FLAVOUR
ITALIA SPA
### A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS 58.3536.1P PHA LIME FLAVOUR
ITALIA SPA
### A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS 20.4579.1P PHA MIXED BERRIES FLAVOUR
ITALIA SPA
### A IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS 58.3520.1P PHA LEMON FLAVOUR
ITALIA SPA
### I II 3/11/2011 DR REDDYS LABORATORIES LTD ESOMEPRAZOLE MAGNESIUM (AMORPHOUS)
[PROCESS-3]
### A II 3/10/2011 SINTENOVO SA DE CV MONTELUKAST SODIUM
### A II 3/10/2011 NECTAR LIFESCIENCES LTD CEFOTAXIME SODIUM USP (STERILE) DRUG
SUBSTANCE
### A II 3/10/2011 HENAN LIHUA PHARMACEUTICAL CO PREDNISONE
LTD
### A II 3/14/2011 INDUSTRIALE CHIMICA SRL BUMETANIDE
### A II 3/10/2011 MARUHA NICHIRO CORP SODIUM HYALURONATE FH AND SODIUM
HYALURONATE FL
### A II 3/8/2011 ZHEJIANG APELOA JIAYUAN IRBESARTAN API
PHARMACEUTICAL CO LTD
### A II 2/28/2011 MICRO LABS LTD DORZOLAMIDE HYDROCHLORIDE USP
### A II 2/1/2011 ALEMBIC PHARMACEUTICALS LTD AZITHROMYCIN MONOHYDRATE USP
(PROCESS-II)
### I II 3/10/2011 CHANGZHOU PHARMACEUTICAL ALISKIREN HEMIFUMARATE
FACTORY
### A II 3/31/2011 UNICHEM LABORATORIES LTD ZOLMITRIPTAN USP
### A II 3/15/2011 SRINI PHARMACEUTICALS PRIVATE LTD LEVETIRACETAM USP
### A IV 3/14/2011 HENKEL CORP DURO-TAK 87-6911 PRESSURE SENSITIVE
ADHESIVE
### A II 3/16/2011 PATHEON AUSTRIA GMBH AND CO KG NEOSTIGMINE METHYLSULFATE
Page 782
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 3/7/2011 DISHMAN PHARMACEUTICALS AND QUETIAPINE FUMARATE
CHEMICALS LTD
### A II 3/15/2011 AARTI INDUSTRIES LTD DIFLUNISAL
### A II 3/15/2011 AIR LIQUIDE ELECTRONICS US LP NITRIC OXIDE
### A II 3/15/2011 MACLEODS PHARMACEUTICALS LTD TENOFOVIR DISOPROXIL FUMARATE
### A II 3/28/2011 JUBILANT GENERICS LTD SOLIFENACIN SUCCINATE
### I II 3/28/2011 IPCA LABORATORIES LTD TRAMADOL HYDROCHLORIDE (YT3 PROCESS)
### I II 4/20/2011 IPCA LABORATORIES LTD CLOPIDOGREL BISULFATE USP (XC4 PROCESS)
### A IV 3/31/2011 JRS PHARMA GMBH AND CO KG SODIUM STARCH GLYCOLATE, PH. EUR, NF, JP
### A II 3/28/2011 MACLEODS PHARMACEUTICALS LTD CANDESARTAN CILEXETIL
24811 A II 3/30/2011 DR REDDYS LABORATORIES LTD IMATINIB MESYLATE
### I II 4/1/2011 RICHTER THEMIS MEDICARE I PVT LTD FAMOTIDINE
### A II 3/31/2011 DR REDDYS LABORATORIES LTD PANTOPRAZOLE SODIUM USP [PROCESS-2]
### A II 3/30/2011 DEVATS INDIA PRIVATE LTD NIMORAZOLE
### A II 4/1/2011 MSN LABORATORIES PRIVATE LTD DEXLANSOPRAZOLE SESQUIHYDRATE [ROUTE
CODE - "DP"]
### A II 3/28/2011 PIRAMAL ENTERPRISES LTD QUETIAPINE FUMARATE
### I II 3/31/2011 DR REDDYS LABORATORIES LTD ESLICARBAZEPINE ACETATE
### A II 3/31/2011 DR REDDYS LABORATORIES LTD VALGANCICLOVIR HYDROCHLORIDE USP
(CRYSTALLINE)
### A II 4/4/2011 MERCK AND CIE 1, 2-DIOLEOYL-SN-GLYCERO-3-
PHOSPHOCHLINE (DOPC)
### A IV 4/1/2011 KERRY BIOFUNCTIONAL INGREDIENTS SHEFFCOAT COATING SYSTEMS
INC DBA KERRY BIO SCIENCE
### I II 3/31/2011 DR REDDYS LABORATORIES LTD NEBIVOLOL HYDROCHLORIDE
### A II 3/30/2011 DR REDDYS LABORATORIES LTD FEBUXOSTAT
### A II 3/30/2011 DR REDDYS LABORATORIES LTD BENDAMUSTINE HYDROCHLORIDE
### A II 5/31/2011 NATCO PHARMA LTD IBANDRONATE SODIUM MONOHYDRATE
(INJECTABLE GRADE)
### A II 4/12/2011 GLENMARK PHARMACEUTICALS LTD EZETIMIBE, USP (PROCESS II)
### A II 3/21/2011 CSPC ZHONGNUO PHARMACEUTICAL PENICILLIN G POTASSIUM (NON-STERILE)
SHIJIAZHUANG CO LTD
### A II 4/5/2011 MSN LABORATORIES PRIVATE LTD ZILEUTON USP [ROUTE CODE "ZN"]
Page 784
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 4/5/2011 MSN LABORATORIES PRIVATE LTD SALMETEROL XINAFOATE USP [ROUTE CODE -
SX]
### A II 3/31/2011 DR REDDYS LABORATORIES LTD FOSAPREPITANT DIMEGLUMINE
### I II 4/5/2011 ALEMBIC PHARMACEUTICALS LTD RABEPRAZOLE SODIUM
### A II 4/1/2011 DR REDDYS LABORATORIES LTD VALGANCICLOVIR HYDROCHLORIDE USP
(AMORPHOUS)
### A II 4/6/2011 ALEMBIC PHARMACEUTICALS LTD ILOPERIDONE
### I II 4/6/2011 ALEMBIC PHARMACEUTICALS LTD TOPIRAMATE USP
### A II 3/28/2011 MICRO LABS LTD IRBESARTAN USP
### A II 4/7/2011 MSN PHARMACHEM PRIVATE LTD APREPITANT USP (ROUTE CODE - AP)
### A III 3/25/2011 BESPAK CONSORT MEDICAL PLC BK640 NASAL INTEGRATED DOSE COUNTER
### I II 3/31/2011 QILU TIANHE PHARMACEUTICAL CO LTD ZIPRASIDONE HYDROCHLORIDE (NON -
STERILE API)
### A II 3/26/2011 TAI HENG INDUSTRY CO LTD IMATINIB MESYLATE
### A IV 4/8/2011 MOLKEREI MEGGLE WASSERBURG CAPSULAC 60 INH US
GMBH AND CO KG
### I IV 4/11/2011 FONA INTERNATIONAL INC 803.0115U N-C RED APPLE FLAVOR, NAT
### I IV 4/11/2011 FONA INTERNATIONAL INC 825.441 N-C WILD CHERRY FLAVOR, ART
### I IV 4/11/2011 FONA INTERNATIONAL INC 862.0085U N-C LEMONADE FLAVOR, NAT WONF
### A III 4/11/2011 FORMOSA PLASTICS CORP POLYOLEFIN YUNGSOX POLYPROPYLENE RESINS 5018, 5060,
DIV 5050M, 5090T, 5250T,
5350T,5050S,1020L,1024,2100M,5071,5200XT,5450
XT,5200M,1080,1250D,5060T,5090R,1100,1700D,19
90,5018T
### I II 4/12/2011 ALEMBIC PHARMACEUTICALS LTD CLOPIDOGREL BISULFATE USP
### I II 5/29/2013 SPECGX LLC LEUPROLIDE ACETATE (SPECIAL)
### A II 9/30/2011 SPECGX LLC HYDROCODONE POLISTIREX FOR SUSPENSION,
CODE 7490
### A II 4/8/2011 ACEBRIGHT INDIA PHARMA PRIVATE LTD EFAVIRENZ [DRUG SUBSTANCE (NON-STERILE)]
Page 786
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 4/18/2011 CSPC ZHONGNUO PHARMACEUTICAL CEFOTAXIME SODIUM STERILE
SHIJIAZHUANG CO LTD
### A II 4/26/2011 ZHEJIANG HISUN PHARMACEUTICAL CO GEMCITABINE HYDROCHLORIDE USP
LTD
### A III 4/28/2011 HUDSON COLOR CONCENTRATES AMBER HC72646PVC
### I II 8/16/2011 EPHAR BIOLOGICAL AND CHEMICAL CO ATORVASTATIN CALCIUM (API)
LTD
### A II 4/29/2011 MSN PHARMACHEM PRIVATE LTD RANOLAZINE [ROUTE CODE - "RL"]
### A II 4/5/2011 VINDHYA PHARMA INDIA PVT LTD N-METHYL FLUOXETINE OXALATE(NON-STERILE
DRUG SUBSTANCE INTERMEDIATE)
### A III 4/25/2011 MEENAKSHI FOILS SLITTED & PRINTED FOILS AND SLITTED PVDC
COATED PVC FILMS
### A II 4/20/2011 FIS FABBRICA ITALIANA SINTETICI SPA ESOMEPRAZOLE MAGNESIUM DIHYDRATE
### A II 8/27/2012 CF PHARMA LTD CISATRACURIUM BESYLATE VERSION FA1
### A II 4/29/2011 JIANGSU HENGRUI MEDICINE CO LTD SEVOFLURANE USP, NON-STERILE, BULK DRUG
SUBSTANCE
### A III 4/29/2011 POLYONE CORP EM1002025410
### A II 5/2/2011 SMS PHARMACEUTICALS LTD ELETRIPTAN HYDROBROMIDE MONOHYDRATE
### A II 4/18/2011 YONSUNG FINE CHEMICALS CO LTD BIMATOPROST
### A II 4/18/2011 YONSUNG FINE CHEMICALS CO LTD TRAVOPROST
### A IV 4/27/2011 UNGERER AND CO NATURAL AND ARTIFICIAL LEMON LIME FLVP FT-
867
### I III 4/29/2011 AMPACET CORP 101736 AB PE MB
### A IV 1/12/2011 MINGTAI CHEMICAL CO LTD CROSCARMELLOSE SODIUM NF (PROCESS II)
24911 A III 5/3/2011 SABIC PETROCHEMICALS BV SABIC PP PCGR02 00900
### A II 2/13/2012 VALDEPHARM ETHINYL ESTRADIOL
### A II 5/25/2011 VALDEPHARM NORETHINDRONE ACETATE
### I II 4/30/2011 CADILA HEALTHCARE LTD PALIPERIDONE
### I II 5/2/2011 POLYDRUG LABORATORIES PVT LTD LOSARTAN POTASSIUM
### A II 5/4/2011 MSN PHARMACHEM PRIVATE LTD NEBIVOLOL HYDROCHLORIDE[ROUTE CODE:
"NH"]
### A II 5/2/2011 SCI PHARMTECH INC CLINDAMYCIN PALMITATE HYDROCHLORIDE
### A II 7/30/2011 EMCURE PHARMACEUTICALS LTD ESOMEPRAZOLE SODIUM
### A II 4/8/2011 HUBEI YITAI PHARMACEUTICAL CO LTD ACYCLOVIR(NON-STERILE,BULK FORM)
### I II 4/8/2011 HUBEI YITAI PHARMACEUTICAL CO LTD VALACYCLOVIR HYDROCHLORIDE(NON-
STERILE, BULK FORM)
### A II 5/28/2011 CONCORD BIOTECH LTD TEMSIROLIMUS
### I II 6/8/2011 EMCURE PHARMACEUTICALS LTD BICALUTAMIDE USP
### A II 5/2/2011 SHOUGUANG FUKANG OMEPRAZOLE
PHARMACEUTICAL CO LTD
### A II 5/2/2011 MOEHS IBERICA SL RABEPRAZOLE SODIUM
### A IV 5/5/2011 LIPOID GMBH LIPOID PG 16:0/16:0 (DPPG-NA) AND LIPOID PG
16:0/16:0 CONTAINING EDTA (NMT 1.5%) (DPPG-
NA) (1,2-DIPALMITOYL-SN-GLYCERO-3-
PHOSPHO-RAC-GLYCEROL SODIUM SALT)
Page 787
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 5/4/2011 JRS PHARMA GMBH AND CO KG HYPROMELLOSE USP
### A II 5/2/2012 SPECGX LLC BUPRENORPHINE HYDROCHLORIDE USP, CODE
3210
### A II 5/2/2012 SPECGX LLC BUPRENORPHINE BASE EP, CODE 3205
### A II 5/9/2011 ZACH SYSTEM SPA BOSENTAN MONOHYDRATE
### A III 4/8/2011 BOREALIS AG BORMED RD804CF
### A III 4/8/2011 BOREALIS AG BORMED TD109CF
### A II 5/10/2011 SYMED LABS LTD ILOPERIDONE
### A II 5/11/2011 CHEMI SPA EPTIFIBATIDE
### A II 5/12/2011 TEVA PHARMACEUTICAL INDUSTRIES ACYCLOVIR USP
LTD
### I II 5/10/2011 ZHEJIANG JIANGBEI PHARMACEUTICAL SIMVASTATIN AMMONIUM SALT
CO LTD
### A II 5/12/2011 ULKAR KIMYA SANAYII VE TICARET AS
ETODOLAC
### A II 5/12/2011 ULKAR KIMYA SANAYII VE TICARET AS
ARIPIPRAZOLE
### I III 1/19/2011 HUAYI ISOTOPES CO VACUUM STERILE VIALS
### A II 5/6/2011 SCI PHARMTECH INC DULOXETINE HYDROCHLORIDE
### I IV 5/16/2011 FONA INTERNATIONAL INC 875.0040U N-C ENCAPSULATED MENTHOL
### A II 5/11/2011 FRESENIUS KABI IPSUM SRL BUFFERED OXACILLIN SODIUM STERILE
### I II 5/17/2011 GLOCHEM INDUSTRIES LTD AMLODIPINE BESILATE
### A II 5/17/2011 HETERO LABS LTD EFAVIRENZ (PROCESS II)
### A II 8/23/2011 SHILPA MEDICARE LTD BORTEZOMIB
### A II 6/1/2011 UNIMARK REMEDIES LTD ARMODAFINIL
### I II 10/18/2011 CHEMWERTH INC TETRABENAZINE(NON-STERILE BULK DRUG
SUBSTANCE)
### A II 5/18/2011 HETERO LABS LTD LAMIVUDINE, USP (FORM I)
### A II 10/12/2011 JUBILANT GENERICS LTD ROPIVACAINE HYDROCHLORIDE USP
### A II 10/31/2011 APICORE US LLC CEVIMELINE HYDROCHLORIDE
### A III 5/26/2011 SELECTIVE COATINGS AND INKS INC SCI BOND HEAT SEAL COATINGS
### A IV 5/16/2011 JRS PHARMA GMBH AND CO KG CROSCARMELLOSE SODIUM, PH.EUR., NF, JP
### A IV 5/12/2011 UNGERER AND CO NATURAL AND ARTIFICIAL BUBBLEGUM FLAVOR
FU-3869
### I III 5/16/2011 SAM A ALUMINIUM CO LTD CONTAINER & CLOSURE
### A II 5/6/2011 PIRAMAL ENTERPRISES LTD TRAMADOL HYDROCHLORIDE
### A II 10/12/2011 JUBILANT GENERICS LTD ZIPRASIDONE HYDROCHLORIDE USP
### A II 5/17/2011 SM BIOMED SDN BHD ERYTHROMYCIN BASE USP
### A III 5/17/2011 DOCTORPACK INDIA PVT LTD PLASTIC CONTAINER CLOSURE SYSTEMS 'N'
DESIGN
### A II 6/6/2011 CTX LIFE SCIENCES PVT LTD LAMOTRIGINE USP
### I II 5/2/2011 SHANGHAI DONGYUE BIOCHEM CO LTD CLOPIDOGREL BISULFATE
### A II 5/5/2011 AESICA PHARMACEUTICALS LTD PAROXETINE HYDROCHLORIDE HEMIHYDRATE
### A IV 5/9/2011 HENKEL CORP DURO-TAK 87-6908 PRESSURE SENSITIVE
ADHESIVE
### A II 5/5/2011 SYN-TECH CHEM AND PHARM CO LTD DICLOFENAC EPOLAMINE
Page 788
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 5/18/2011 ZHEJIANG HISUN PHARMACEUTICAL CO TAZOBACTAM USP
LTD
### A II 5/20/2011 SANDOZ GMBH TEMSIROLIMUS
### A II 7/6/2011 IPCA LABORATORIES LTD TRIAMTERENE USP
### A IV 5/18/2011 PHOSPHAGENICS LTD TOCOPHERYL PHOSPHATE MIXTURE
### I II 4/29/2011 SOUTHWEST SYNTHETIC SIMVASTATIN AMMONIUM SALT
PHARMACEUTICAL CO LTD
### A II 10/4/2011 APICORE US LLC NADOLOL, USP
### A II 8/27/2012 CF PHARMA LTD CISATRACURIUM BESYLATE
### I II 5/24/2011 SUN PHARMACEUTICAL INDUSTRIES ATAZANAVIR SULFATE
LTD
### A II 5/16/2011 PERRIGO API LTD IMATINIB MESYLATE ALPHA FORM
### A V 5/7/2011 MICROTROL STERILISATION SERVICES ETHYLENE OXIDE STERILISATION
PVT LTD
### A II 5/25/2011 HETERO DRUGS LTD RABEPRAZOLE SODIUM
### A III 5/1/2011 ESKAY PACKAGING ALUMINIUM COLLAPSIBLE TUBES SUITABLE
FOR PACKAGING PHARMACEUTICAL DOSAGES
### I II 5/18/2011 SHIJIAZHUANG LONZEAL EMTRICITABINE
PHARMACEUTICALS CO LTD
### A II 5/25/2011 HETERO DRUGS LTD CLOPIDOGREL BISULFATE (FORM-I)
### A II 5/18/2011 LUNAN NEW TIME BIO TECH CO LTD MYCOPHENOLIC ACID
### I II 5/20/2011 JINAN JINDA PHARMACEUTICAL NITROFURANTOIN MONOHYDRATE
CHEMISTRY CO LTD
### A III 5/23/2011 DOCTORPACK INDIA PVT LTD PLASTIC CONTAINER CLOSURE SYSTEM 'S'
DESIGN
### A II 5/21/2011 JINAN JINDA PHARMACEUTICAL NITROFURANTOIN
CHEMISTRY CO LTD
### A II 5/16/2011 CKD BIO CORP MYCOPHENOLATE MOFETIL, NON-STERILE
BULK DRUG SUBSTANCE
### A II 5/25/2011 HETERO DRUGS LTD OMEPRAZOLE MAGNESIUM
### I IV 5/25/2011 FONA INTERNATIONAL INC 915.0527U N-C STRAWBERRY FLAVOR, NAT
WONF
### A IV 5/25/2011 FONA INTERNATIONAL INC 828.0030U CITRUS BLEND FLAVOR, ART
### I IV 5/25/2011 FONA INTERNATIONAL INC 862.0061U N-C LEMON FLAVOR, NAT WONF
### A III 8/26/2011 RADPHARM SCIENTIFIC RADPHARM STERILE EVACUATED GLASS VIALS
10ML, 20ML, 30ML
### I II 5/27/2011 SANDOZ GMBH FILGRASTIM (G-CSF)
### A II 5/26/2011 PIRAMAL ENTERPRISES LTD TOLCAPONE
### A III 5/26/2011 HMC POLYMERS CO LTD PURELL RP271M
### A III 5/26/2011 DOCTORPACK INDIA PVT LTD PLASTIC CONTAINER CLOSURE SYSTEM 'MRL'
DESIGN
### A II 5/27/2011 CORDEN PHARMA COLORADO INC LINACLOTIDE
### A III 5/27/2011 NUSSBAUM MATZINGEN AG ALUMINUM CANS
### A III 5/27/2011 MYLAN TECHNOLOGIES INC MEDIRELEASE 2500
Page 789
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 5/25/2011 ST GOBAIN PERFORMANCE PLASTICS C-FLEX ULTRA TPE TUBING
CORP
### A II 5/27/2011 ZHOUSHAN SINOMEGA BIOTECH OMEGA-3 REFINED FISH OIL
ENGINEERING CO LTD
### A II 6/7/2011 AUROBINDO PHARMA LTD ARIPIPRAZOLE USP (NON-STERILE DRUG
SUBSTANCE)
### A II 5/27/2011 HETERO DRUGS LTD PROGUANIL HYDROCHLORIDE, USP
### A II 5/30/2011 FARMHISPANIA SA CISATRACURIUM BESYLATE USP
### I II 10/14/2011 INDOCO REMEDIES LTD QUETIAPINE FUMARATE
### A II 5/31/2011 MACLEODS PHARMACEUTICALS LTD EMTRICITABINE
### A III 6/1/2011 FORMOSA CHEMICALS AND FIBRE CORP TAIRIPRO POLYPROPYLENE RESINS: K1023,
T3002, F4007, K4515, K4535 & K4520
### A II 11/4/2011 LUPIN LTD EFAVIRENZ USP
### A IV 5/26/2011 UNGERER AND CO FW-3484 NAT/ ART MELON FLAVOR
### A II 5/19/2011 ZHEJIANG APELOA JIAYUAN LEVETIRACETAM
PHARMACEUTICAL CO LTD
### I II 5/31/2011 TORONTO RESEARCH CHEMICALS INC 2-AMINO-3,8-DIMETHYLIMIDAZOL[4,5-
F]QUINOXALINE-2-14C
### I II 6/1/2011 PHARMAZELL VIZAG PRIVATE LTD RISEDRONATE SODIUM HEMIPENTAHYDRATE
USP
### A II 6/1/2011 TOKO PHARMACEUTICAL INDUSTRIES TAMIBAROTENE
CO LTD
### A II 6/3/2011 SOLARA A PHARMA SCIENCES LTD ZIDOVUDINE
### I II 5/20/2011 KOPRAN LTD ATENOLOL
25011 A II 5/31/2011 PARABOLIC DRUGS LTD PENTOSAN POLYSULFATE SODIUM
### I III 6/3/2011 SCHOTT NAIGAI KK INJECTION VIALS AND SCREW NECK VIALS IN
CLEAR GLASS AND AMBER GLASS
### A II 6/7/2011 SHARON BIO MEDICINE LTD KETOCONAZOLE USP
### I II 9/5/2011 AMI ORGANICS PVT LTD 1- (2,3-DICHLORO PHENYL) PIPERAZINE
HYDROCHLORIDE
### I II 9/5/2011 AMI ORGANICS PVT LTD 1-[2-(2-HYDROXY ETHOXY) ETHYL] PIPERAZINE
### A II 2/21/2012 NECTAR LIFESCIENCES LTD CEFEPIME HYDROCHLORIDE USP (STERILE)
### A II 12/22/2011 NECTAR LIFESCIENCES LTD CEFEPIME HYDROCHLORIDE (NON-STERILE)
DRUG SUBSTANCE
### A II 10/8/2011 NECTAR LIFESCIENCES LTD PYCA (NON-STERILE DRUG SUBSTANCE
INTERMEDIATE)
### A IV 6/1/2011 LIPOID GMBH LIPOID LIPIDMIX HSPC/MPEG2000-
DSPE/CHOLESTEROL (3/1/1)
### I II 6/6/2011 SANOFI CHIMIE SEMULOPARIN SODIUM
### A II 6/1/2011 POLYPEPTIDE LABORATORIES SWEDEN LINACLOTIDE DRUG SUBSTANCE
AB
### A II 6/27/2011 GLENMARK PHARMACEUTICALS LTD MILNACIPRAN HYDROCHLORIDE
### A II 6/8/2011 INTERQUIM SA OZENOXACIN
### A II 6/8/2011 TEVA PHARMACEUTICAL INDUSTRIES SIMVASTATIN (ETHANOL PROCESS)
LTD
Page 790
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 6/7/2011 POLYPEPTIDE LABORATORIES INC LINACLOTIDE DRUG SUBSTANCE
### A III 5/25/2011 TEXOL SRL PERFORATED LAMINATE TOPSHEET 43 GSM
### I III 6/1/2011 KURARAY TRADING CO LTD KG001, POLYPROPYLENE-KNITTED BACKING
CLOTH FOR MEDICAL PATCHES
### A II 6/9/2011 HETERO LABS LTD EFAVIRENZ(FORM-H1)
### A II 6/9/2011 HETERO LABS LTD TELMISARTAN, USP (FORM A)
### A II 2/4/2011 VITAL LABORATORIES PVT LTD RESERPINE USP
### A II 6/23/2011 ORCHID PHARMA LTD ARMODAFINIL
### A II 6/18/2011 ORCHID PHARMA LTD RABEPRAZOLE SODIUM
### A III 5/3/2011 SABIC PETROCHEMICALS BV SABIC PP PCGR25 00900
### I II 6/10/2011 DK PHARMA CHEM PVT LTD FENOFIBRATE USP
### A II 5/9/2011 CSPC ZHONGNUO PHARMACEUTICAL AMPICILLIN TRIHYDRATE
SHIJIAZHUANG CO LTD
### A II 6/9/2011 MACLEODS PHARMACEUTICALS LTD DULOXETINE HYDROCHLORIDE
### A III 6/8/2011 INOVYN EUROPE LTD INOVYN TM PVC 372HA
### I IV 4/30/2011 BALAJI AMINES LTD UNIT III POVIDONE USP-31
### A II 7/1/2011 EMCURE PHARMACEUTICALS LTD SEVELAMER CARBONATE (PROCESS II)
### A II 7/1/2011 EMCURE PHARMACEUTICALS LTD MELPHALAN HYDROCHLORIDE
### A III 6/2/2011 INEOS SERVICES BELGIUM NV ELTEX MED HD5226EA-M
### I III 6/7/2011 3M DRUG DELIVERY SYSTEMS GAMMA RADIATION STERILIZATION PROCESSES
AND FACILITIES AS LOCATED IN SWINDON,
ENGLAND
### I II 6/13/2011 SANDOZ PRIVATE LTD LANSOPROZOLE
### A II 6/13/2011 CRYSTAL PHARMA SAU OLOPATADINE HYDROCHLORIDE, USP
(PROCESS II)
### A III 6/13/2011 MITSUI ELASTOMERS SINGAPORE PTE TAFMER MY-1, MY-2, XM7070, XM7080 AND PN-
LTD 9060
### A IV 6/9/2011 NIPPON FINE CHEMICAL CO LTD PRESOME ESI
### A III 6/15/2011 TOPPAN PRINTING CO LTD LOW ADSORPTION LAMINATED PACKAGING
MATERIAL PET/AL/SEALANT FILMS SERIES
### A II 6/14/2011 MACLEODS PHARMACEUTICALS LTD ZIPRASIDONE HYDROCHLORIDE
### A II 6/9/2011 PCAS ESOMEPRAZOLE MAGNESIUM DIHYDRATE
### I II 6/2/2011 PORTON FINE CHEMICALS LTD ROSUVASTATIN CALCIUM
### A II 7/5/2011 UNICHEM LABORATORIES LTD BRIMONIDINE TARTRATE
### A II 6/16/2011 DIPHARMA FRANCIS SRL FESOTERODINE FUMARATE
### I III 6/8/2011 3M DRUG DELIVERY SYSTEMS GRANGEMOUTH SITE (SUITE 5)
### A II 6/14/2011 ACEBRIGHT INDIA PHARMA PRIVATE LTD CAPECITABINE USP[DRUG SUBSTANCE (NON-
STERILE)]
### A II 7/20/2011 CADILA HEALTHCARE LTD PROPAFENONE HYDROCHLORIDE USP
### A II 6/17/2011 HUBEI GEDIAN HUMANWELL FINASTERIDE
PHARMACEUTICAL CO LTD
### I III 5/12/2011 AMCOR FLEXIBLES AS OPP40/ALU9/OPP40
### I II 6/15/2011 RA CHEM PHARMA LTD PHTHALAZINONE
Page 791
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 6/17/2011 MINNESOTA RUBBER AND PLASTICS POLYISOPRENE RUBBER FOR SEALING AND
OTHER MEDICAL-RELATED APPLICATIONS IN
MEDICAL DEVICES
### I II 6/14/2011 CHEMSPEC CHEMICALS PVT LTD TRICLOCARBAN
### I II 6/20/2011 PHARMACEUTICAL WORKS POLPHARMA MONTELUKAST SODIUM
SA
### A II 6/16/2011 RAKS PHARMA PVT LTD DOXYCYCLINE USP
### A III 6/14/2011 RAVIRAJ FOILS LTD CHILD RESISTANT BLISTER PACK LIDDING
MATERIAL (PLAIN / PRINTED)
### A II 6/21/2011 MSN PHARMACHEM PRIVATE LTD PREGABALIN USP [ROUTE CODE - "PU"]
### A II 6/16/2011 RAKS PHARMA PVT LTD CITALOPRAM HYDROBROMIDE, USP
### I III 6/14/2011 LORMAC INDUSTRIAL DISTRIBUTORS LORMAC 40 POLYETHYLENE
LTD
### A II 6/18/2011 ZHEJIANG XIANJU PHARMACEUTICAL METHYLPREDNISOLONE USP, NON-STERILE
CO LTD BULK DRUG SUBSTANCE
### A II 6/22/2011 MOEHS IBERICA SL ARTICAINE HCL
### I II 6/22/2011 APOTEX PHARMACHEM INDIA PVT LTD LETROZOLE USP
### A II 6/20/2011 RN LABORATORIES PVT LTD CHLORHEXIDINE HYDROCHLORIDE
### I III 6/10/2011 RKW SE HYFOL PE SOFT TEXTILE - 45701
### A III 1/22/2014 SCHOTT SCHWEIZ AG PRIMARY PACKAGING MATERIAL SYRINGES
### A II 6/24/2011 APOTEX PHARMACHEM INDIA PVT LTD PALIPERIDONE USP
### I II 6/24/2011 APOTEX PHARMACHEM INDIA PVT LTD ALPRAZOLAM USP
### A II 6/24/2011 COVALENT LABORATORIES PRIVATE LTD CEFUROXIME AXETIL USP (AMORPHOUS)
### A III 7/11/2011 BASELL POLYOLEFINE ITALIA SRL PURELL ACP 5231 D
### A II 9/9/2011 CHEMWERTH INC CLOCORTOLONE PIVALATE
### A IV 7/15/2011 JIANGSU ZODIAC PHARMACEUTICALS HPMC VEGETABLE EMPTY HARD CAPSULES
CO LTD
### A III 6/6/2011 INEOS STYROLUTION EUROPE GMBH TERLUX R HD 2822
### A II 10/19/2011 LUPIN LTD L-5-METHYL TETRAHYDROFOLATE CALCIUM
(AMORPHOUS)
### I II 8/20/2011 ARCH PHARMALABS LTD DOCETAXEL ANHYDROUS USP
### I II 9/5/2011 ARCH PHARMALABS LTD DOCETAXEL TRIHYDRATE USP
### I II 8/6/2011 CADILA HEALTHCARE LTD ZYFINE ERLOTINIB HYDROCHLORIDE (FORM-A)
### A II 8/4/2011 JUBILANT HOLLISTERSTIER LLC STERILE EVACUATED VIALS
### A IV 7/19/2011 UNGERER AND CO ARTIFICIAL PINA COLADA FLAVOR FT-11512
### I II 7/20/2011 ZHEJIANG HISUN PHARMACEUTICAL CO SIROLIMUS
LTD
### A II 3/4/2011 ALP PHARM BEIJING CO LTD DOXERCALCIFEROL
### A II 7/25/2011 MEDICHEM SA CHLORHEXIDINE GLUCONATE SOLUTION
(DGLP)
### A III 7/18/2011 PIRAMIDA DOO PHARMACEUTICAL GLASS PACKAGING -
AMPOULES AND VIALS
### A II 7/21/2011 ZHEJIANG APELOA KANGYU AMANTADINE HYDROCHLORIDE USP
PHARMACEUTICAL CO LTD
### A II 7/29/2011 ALKEM LABORATORIES LTD LANSOPRAZOLE USP
### I III 7/19/2011 AMPACET CORP 173834 TRANS GREEN SMC PE MB
### A II 5/20/2011 AICELLOMILIM CHEMICAL CO LTD ADF-03 (CLEAN BAG)
### A II 9/29/2011 UNICHEM LABORATORIES LTD TOLTERODINE TARTRATE USP
### I II 11/11/2011 RELIANCE LIFE SCIENCES PVT LTD ROCURONIUM BROMIDE USP
### A V 5/18/2011 ROTEM INDUSTRIES LTD CASSETTE FOR THE PRODUCTION OF
FLUORINE-18 FLUDEOXYGLUCOSE ON THE
TRACERLAB MX FDG SYNTHESIS UNIT, B AS
MANUFACTURED IN MISHOR YAMIN , ISRAEL
### A II 7/25/2011 TARGAZYME INC TZ-101
### I III 7/26/2011 JSR CORP JSR DYNARON SERIES (HYDROGENATED
STYRENE BUTADIENE COPOLYMER)
Page 794
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 9/16/2011 HOSPIRA INC ANSYR SYRINGE DRUG CONTAINER
### A II 7/25/2011 PCAS TAZAROTENE
### A III 7/27/2011 COLORS FOR PLASTICS INC THERMOPLASTIC RESIN COLORANT
MASTERBATCH N06534 BROWN
### A III 7/25/2011 ELIX POLYMERS SL ELIX ABS M210TF, VARIOUS COLORS
### A IV 7/26/2011 UNGERER AND CO NATURAL AND ARTIFICIAL CHERRY FLVP FT-9496
Page 797
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 8/23/2011 ZHEJIANG SUPOR PHARMACEUTICALS BUPROPION HYDROBROMIDE
CO LTD
### A II 9/1/2011 NOF CORP DLINDMA (1,2-DILINOLEYLOXY-N,N-
DIMETHYLPROPYLAMINE
### A II 9/1/2011 VIFOR INTERNATIONAL INC CARBOXYMETHYLATED DEXTRAN (CM
DEXTRAN)
### I II 5/3/2012 AMI ORGANICS PVT LTD 1- (2-METHOXYPHENYL) PIPERAZINE
HYDROCHLORIDE
### A II 10/11/2011 IPCA LABORATORIES LTD PRIMAQUINE PHOSPHATE USP
### A II 10/10/2011 LUPIN LTD BRIMONIDINE TARTRATE
### A II 9/24/2011 ALKEM LABORATORIES LTD RILUZOLE USP
### A II 9/6/2011 HETERO DRUGS LTD RALTEGRAVIR POTASSIUM
### A II 9/6/2011 HETERO LABS LTD EFAVIRENZ (PROCESS III) USP
### A II 9/2/2011 EVERLIGHT CHEMICAL INDUSTRIAL TRAVOPROST
CORP
### A V 8/31/2011 ION BEAM APPLICATIONS SA RADIO-PHARMACEUTICAL
PURIFICATION/SEPARATION MODULE
SYNTHERA® HPLC
### I II 9/7/2011 EUTICALS SPA AZACITIDINE
### A II 9/7/2011 EUTICALS SPA CAPECITABINE
### A II 9/7/2011 EUTICALS SPA CYTARABINE
### I II 4/27/2011 TOMITA PHARMACEUTICAL CO LTD U.S.P. MAGNESIUM SULFATE, ANHYDROUS
### I II 5/10/2011 TOMITA PHARMACEUTICAL CO LTD U.S.P. MAGNESIUM GLUCONATE
### I II 5/23/2011 TOMITA PHARMACEUTICAL CO LTD U.S.P. MAGNESIUM OXIDE HEAVY POWDER
### I II 5/23/2011 TOMITA PHARMACEUTICAL CO LTD U.S.P. MAGNESIUM OXIDE HEAVY FINE
GRANULAR
### I II 2/28/2011 TOMITA PHARMACEUTICAL CO LTD U.S.P. MAGALDRATE
### A II 10/6/2011 BAYER AG NICLOSAMIDE ANHYDROUS DRUG SUBSTANCE
### A II 10/6/2011 BAYER AG NICLOSAMIDE 500MG TABLET
### A II 7/25/2011 SYMBIOTICA SPECIALITY INGREDIENTS EXEMESTANE
SDN BHD
### A II 9/8/2011 BAXTER HEALTHCARE CORP MESNA, USP/EP DRUG SUBSTANCE
### A III 8/30/2011 CELGARD LLC CELGARDr 2300 SERIES TRANSDERMAL FLAT
SHEET MEMBRANE
### A III 10/5/2011 PLASTITEC SA PVC BAGS AND ITS COMPONENTS FOR
PHARMACEUTICAL SOLUTIONS
### A II 3/30/2012 JUBILANT GENERICS LTD LEVOCETIRIZINE DIHYDROCHLORIDE
### A II 9/12/2011 HETERO DRUGS LTD DULOXETINE HYDROCHLORIDE
### A II 9/6/2011 HETERO DRUGS LTD RALOXIFENE HYDROCHLORIDE USP
### I II 9/8/2011 ZAKLADY FARMACEUTYCZNE DARIFENACIN HYDROBROMIDE
POLPHARMA SA
### A II 8/31/2011 OLON SPA OTILONIUM BROMIDE
### A III 9/6/2011 ELIX POLYMERS SL ELIX ABS M205FC, VARIOUS COLORS
### A II 4/1/2015 CHATTEM CHEMICALS INC HYDROCODONE BITARTRATE USP
### A II 5/9/2012 CHATTEM CHEMICALS INC METHADONE HYDROCHLORIDE USP
Page 798
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 9/9/2011 SANOFI AVENTIS SPA RIFAMYCIN SODIUM
### A III 9/6/2011 ELIX POLYMERS SL ELIX ABS M203FC, VARIOUS COLORS
### A II 9/12/2011 CATALENT PHARMA SOLUTIONS LLC AMR101 1G CAPSULES
### A III 9/7/2011 ADVANCED FILMS LLC MEDICAL POUCH FILM, PRODUCT CODE F-19
### A III 8/11/2011 TRUDELL MEDICAL INTERNATIONAL TOP MOUNT ACTUATION INDICATOR
### A II 9/7/2011 FUJIAN SOUTH PHARMACEUTICAL CO 10-DEACETYL-BACCATIN III (10-DAB III) (NON-
LTD STERILE)
### A II 9/7/2011 FUJIAN SOUTH PHARMACEUTICAL CO DOCETAXEL ANHYDROUS, NON-STERILE, BULK
LTD DRUG SUBSTANCE
### A II 9/12/2011 HETERO DRUGS LTD NEBIVOLOL HYDROCHLORIDE
### A II 9/13/2011 HETERO DRUGS LTD ZOLMITRIPTAN
### A II 9/11/2011 HIKMA PHARMACEUTICALS GRANISETRON HYDROCHLORIDE USP
### A III 10/19/2011 WEENER EMPIRE PLASTICS LTD PLASTIC CLOSURES
### A II 9/13/2011 DISHMAN NETHERLANDS BV PARICALCITOL
### A II 9/22/2011 INDOCO REMEDIES LTD BETAXOLOL HYDROCHLORIDE USP
### A II 8/16/2011 VITAL HEALTH CARE PVT LTD NIMESULIDE
### A II 9/15/2011 QILU ANTIBIOTICS PHARMACEUTICAL CEFEPIME FOR INJECTION
CO LTD
### A II 9/13/2011 SHANGHAI DESANO CHEMICAL TENOFOVIR DISOPROXIL FUMARATE
PHARMACEUTICAL CO LTD
### A II 9/13/2011 SHANGHAI DESANO CHEMICAL ATOVAQUONE
PHARMACEUTICAL CO LTD
### A II 6/9/2011 VITAL HEALTH CARE PVT LTD ARTEMETHER
### A III 9/12/2011 AMPACET CORP 412978 WHITE POLYPROPYLENE MASTERBATCH
Page 799
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 9/24/2011 MSN LABORATORIES PRIVATE LTD ALMOTRIPTAN MALATE USP [ROUTE CODE - AM]
### A IV 10/24/2011 ABELEI INC 113A86 NATURAL & ARTIFICIAL BERRY FLAVOR
POWDER
### A IV 10/24/2011 ABELEI INC 144A147 NATURAL & ARTIFICIAL TROPICAL
FLAVOR POWDER
### A III 10/21/2011 POLYCINE GMBH APP147
### A III 9/21/2011 EXTRAL SA DE CV ALUMINUM BARRIER LAMINATION (ABL) AND
PLASTIC BARRIER LAMINATION (PBL)
IMPRESSION
### A II 12/29/2011 EMCURE PHARMACEUTICALS LTD BUSULFAN USP
### A II 12/31/2011 SUN PHARMACEUTICAL INDUSTRIES SEVELAMER HYDROCHLORIDE
LTD
### I II 12/6/2011 RELIANCE LIFE SCIENCES PVT LTD LOTEPREDNOL ETABONATE
### A II 10/7/2011 AVANTI POLAR LIPIDS INC 1,2-DISTEAROYL-SN-GLYCERO-3-
PHOSPHOCHOLINE (DSPC) (730365)
### A III 10/25/2011 SIBO G DOO CONTAINERS SIBO
### A IV 10/25/2011 SEPPIC SA MONTANE 20 PPI
### A III 10/21/2011 TEKNI-PLEX INC (DBA TRI-SEAL) CLOSURE LINERS
### A II 10/31/2011 MAC CHEM PRODUCTS INDIA PVT LTD SUCCINYLCHOLINE CHLORIDE USP
### A III 9/24/2011 ESSEL PROPACK LTD LAMINATED TUBES
### I III 10/11/2011 SANDLER AG NONWOVEN SAWABOND 4163
### A II 11/28/2011 ORCHID PHARMA LTD CEFEPIME HCI USP
### I II 12/20/2012 GLAXOSMITHKLINE LLC CLOBETASOL PROPIONATE
### I II 11/12/2011 CADILA HEALTHCARE LTD IRBESARTAN USP
### A II 2/8/2012 CADILA HEALTHCARE LTD DESVENLAFAXINE SUCCINATE
### A II 10/31/2011 SYMBIOTEC PHARMALAB PRIVATE LTD MOMETASONE FUROATE MONOHYDRATE
### A IV 10/31/2011 CELANESE EVA PERFORMANCE ETHYLENE VINYL ACETATE COPOLYMER,
POLYMERS ATEVA®K2356.XO1
### I V 10/31/2011 ROTEM INDUSTRIES LTD DISPOSABLE CASSETTE FOR VIAL FILLER
SYSTEM
### I III 10/27/2011 AMPACET CORP 100665 MOLD RELEASE PP MB
### I III 10/27/2011 AMPACET CORP 122103 SILVER PEARL PE MB
### A III 10/27/2011 AMPACET CORP 169617 PEARL VIOLET PE MB
### A II 11/15/2011 CHEMSPEC API MENADIOL SODIUM DIPHOSPHATE
### A II 10/21/2011 ZHEJIANG HUAHAI PHARMACEUTICAL CANDESARTAN CILEXETIL USP
CO LTD
### A II 10/10/2011 VASUDHA PHARMA CHEM LTD CYPROHEPTADINE HCL USP
### A II 10/17/2011 BIOPHORE INDIA PHARMACEUTICALS PENTETIC ACID
PVT LTD
### A III 11/2/2011 GIL PLASTIC PRODUCTS LTD PLASTIC JARS AND BOTTLES
Page 803
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 11/2/2011 CELANESE EVA PERFORMANCE ETHYLENE VINYL ACETATE COPOLYMER,
POLYMERS ATEVA® K2357.X01
### A II 11/15/2011 JUBILANT HOLLISTERSTIER LLC STERILE EMPTY VIALS
### A II 10/7/2011 CHENG FONG CHEMICAL CO LTD PROCAINAMIDE HYDROCHLORIDE
### A II 12/14/2011 PAR PHARMACEUTICAL INC PIMOZIDE USP
### A IV 11/3/2011 CELANESE EVA PERFORMANCE ETHYLENE VINYL ACETATE COPOLYMER,
POLYMERS VITALDOSE K2418.X01
### A II 10/20/2011 ZHEJIANG APELOA JIAYUAN CLOPIDOGREL BISULFATE
PHARMACEUTICAL CO LTD
### A II 9/29/2011 KEKULE PHARMA LTD NILUTAMIDE
### A II 10/31/2011 SYN-TECH CHEM AND PHARM CO LTD TOLPERISONE HYDROCHLORIDE
### A II 11/3/2011 EXEMED PHARMACEUTICALS METFORMIN HYDROCHLORIDE USP
### I II 10/19/2011 HUAYI ISOTOPES CO RK-100
### A II 10/10/2011 HUAYI ISOTOPES CO OXYGEN-18 WATER
### A II 11/19/2011 ARCH PHARMALABS LTD CLOPIDOGREL CAMPHOR SULPHONATE SALT
### A III 3/22/2012 PADMA POLYTEX INDIA PVT LTD PLASTIC POUCHES (POLY BAGS)
### A II 1/10/2012 MACLEODS PHARMACEUTICALS LTD ARIPIPRAZOLE
### A III 11/9/2011 METALCO SRL ALUMINUM CONTAINERS FOR BULK DRUGS
SUBSTANCES
### I II 10/28/2011 FINORGA SAS FENOFIBRATE
### A IV 10/31/2011 PHOSPHOLIPID GMBH PHOSAL ®35 SB CGMP
### A III 10/31/2011 FUJIMORI KOGYO CO LTD RELEASE LINER FILM FOR USE IN
TRANSDERMAL DRUG DELIVERY PATCHES **E-
0010 GT
### A II 11/3/2011 FRESENIUS KABI IPSUM SRL AMPICILLIN SODIUM/SULBACTAM SODIUM
### A II 11/7/2011 ICROM SPA BRINZOLAMIDE (MICRONIZED AND NON
MICRONIZED, STERILE AND NON STERILE)
### A II 11/4/2011 MEISSNER FILTRATION PRODUCTS INC FLUOROFLEX BIOCONTAINERS
### A III 10/31/2011 AURIGA POLYMERS INC POLYETHYLENE TEREPHTHALATE RESINS,
SPARTANBURG, SC
### I II 11/7/2011 DERIVADOS QUIMICOS SAU DIOXANONE
### I II 11/8/2011 HETERO LABS LTD BORTEZOMIB (FORM-II)
### A II 11/8/2011 TEVA PHARMACEUTICAL INDUSTRIES IRBESARTAN USP
LTD
### I II 12/6/2011 EMCURE PHARMACEUTICALS LTD ANASTROZOLE USP
### A III 10/28/2011 PG FOILS LTD PRIMARY PACKAGING MATERIAL
### A II 11/8/2011 TOYOX CO LTD TOYOX SILICONE HOSE, TOYOFUSSO HOSE
SERIES
### A III 11/1/2011 JIANGSU CHAOHUA GLASSWORK CO CONTAINERS FOR PARENTERAL PREPARATIONS
LTD MADE OF NEUTRAL-BOROSILICATE GLASS ( I,
USP) TUBING
### I II 12/23/2011 PHF SA SOLIFENACIN SUCCINATE
### A III 11/1/2011 JIANGSU CHAOHUA GLASSWORK CO CONTAINERS FOR PARENTERAL PREPARATIONS
LTD MADE OF LOW-BOROSILICATE GLASS TUBING
( I, USP)
Page 804
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 11/8/2011 AVANTI POLAR LIPIDS INC 1,2-DIMYRISTOYL-SN-GLYCERO-3-
PHOSPHOCHOLINE (DMPC) (730345)
### A II 12/7/2011 SHILPA MEDICARE LTD BUSULFAN USP
### I II 11/8/2011 APOTEX PHARMACHEM INDIA PVT LTD LINEZOLID
### A II 11/8/2011 APOTEX PHARMACHEM INDIA PVT LTD LANSOPRAZOLE USP
### I II 11/8/2011 APOTEX PHARMACHEM INDIA PVT LTD OLMESARTAN MEDOXOMIL USP
### I II 11/3/2011 INTAS PHARMACEUTICALS LTD DOCETAXEL ANHYDROUS USP
### I II 1/3/2012 PIRAMAL HEALTHCARE UK LTD SPIRONOLACTONE USP
### A II 11/18/2011 CHEMSPEC API ISOCARBOXAZID
### I II 11/11/2011 TORRENT PHARMACEUTICALS LTD LEVODOPA
### A II 11/10/2011 HANGZHOU ZHONGMEI HUADONG PANTOPRAZOLE SODIUM
PHARMACEUTICAL CO LTD
### A III 11/11/2011 PFP TERMOPOLIMEROS SL BOTE 1500ML HDPE/BO-TE US
### A II 11/7/2011 SUNBIO INC METHOXY POLYETHYLENE GLYCOL
BENZOTRIAZOLYL CARBONATE 20,000
### A III 10/28/2011 CONSOLIDATED BOTTLE CORP 1 X 2" NATURAL PP VIAL PRINTED WITH LINE -
BLUE"
### A II 12/20/2011 ALEMBIC PHARMACEUTICALS LTD ZOLMITRIPTAN USP
### A II 6/2/2011 SANOFI AVENTIS DEUTSCHLAND GMBH PREDNICARBATE
### I II 11/4/2011 BD BIOSCIENCES ADVANCED BD RECHARGE WITHOUT GLUCOSE AND L-
BIOPROCESSING GLUTAMINE
### A II 11/14/2011 DISHMAN CARBOGEN AMCIS LTD ROPIVACAINE HYDROCHLORIDE
MONOHYDRATE
### A II 11/15/2011 SIEGFRIED USA LLC BUPRENORPHINE HYDROCHLORIDE USP
### I II 11/17/2011 IROKO PHARMACEUTICALS LLC MELOXICAM SOLUMATRIX® CAPSULES
### I II 11/14/2011 ZHUHAI RUNDU PHARMACEUTICAL CO IRBESARTAN
LTD
### I II 11/14/2011 ZHUHAI RUNDU PHARMACEUTICAL CO VALSARTAN
LTD
25511 A II 11/17/2011 JIANGSU HENGRUI MEDICINE CO LTD CISATRACURIUM BESYLATE, USP, NON-STERILE,
BULK DRUG SUBSTANCE
### A II 11/18/2011 HERAEUS DEUTSCHLAND GMBH AND BENDAMUSTINE HYDROCHLORIDE
CO KG MONOHYDRATE
### A II 11/15/2011 MSN ORGANICS PRIVATE LTD TADALAFIL USP [ROUTE CODE - "TD"]
### A II 11/22/2011 SMS PHARMACEUTICALS LTD ITRACONAZOLE USP
### A III 9/12/2011 GRUPO ARCO IRIS PLASTICOS SA DE CV HDPE & LDPE BOTTLES
Page 805
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 11/22/2011 JIANGSU HENGRUI MEDICINE CO LTD CAPECITABINE USP, NON-STERILE, BULK DRUG
SUBSTANCE
### A III 11/18/2011 AMERICHEM INC 61936-CD2 TAN COLORANT
### A II 11/24/2011 ICROM SPA AMISULPRIDE
### A II 11/24/2011 CHONGQING HUAPONT BENDAMUSTINE HCL
PHARMACEUTICAL CO LTD
### A II 11/23/2011 PHYTON BIOTECH LLC PACLITAXEL PRODUCED BY PLANT CELL
FERMENTATION USP
### A II 11/21/2011 FRESENIUS KABI IPSUM SRL BUFFERED PENICILLIN G POTASSIUM STERILE
### A II 11/28/2011 ALEMBIC PHARMACEUTICALS LTD O-DESMETHYL VENLAFAXINE
### I II 12/17/2014 CHEMWERTH INC NEPAFENAC
### A II 12/8/2011 TORRENT PHARMACEUTICALS LTD DARIFENACIN HYDROBROMIDE
### A II 5/14/2012 CHENGDU SHENGNUO BIOPHARM CO BIVALIRUDIN (NON-STERILE BULK DRUG)
LTD
### A II 12/16/2011 FRESENIUS KABI ONCOLOGY LTD DECITABINE
### A II 11/21/2011 ZHEJIANG APELOA JIAYUAN METAXALONE
PHARMACEUTICAL CO LTD
### A II 11/28/2011 SYMBIOTEC PHARMALAB PRIVATE LTD TESTOSTERONE UNDECANOATE
### A II 11/28/2011 SYMBIOTEC PHARMALAB PRIVATE LTD TESTOSTERONE PROPIONATE, USP
(MICRONIZED)
### A II 11/16/2011 DAEWOONG BIO INC URSODIOL USP (PROCESS I)
### I II 11/28/2011 SEIKAGAKU CORP SODIUM HYALURONATE
### A II 12/6/2011 COSMA SPA GLICLAZIDE
### A III 5/5/2011 VERSALIS SPA RIBLENE MP 31 R
### A III 5/5/2011 VERSALIS SPA RIBLENE MR 10 R
### A II 11/30/2011 FERMION OY OSPEMIFENE
### A II 11/29/2011 AVANTHERA SA BEXAROTENE
### A II 11/30/2011 NEULAND LABORATORIES LTD EZETIMIBE USP (FORM-X)
### A II 11/24/2011 HIKMA PHARMACEUTICALS PLC MILRINONE, USP
### A II 11/29/2011 FRESENIUS KABI IPSUM SRL PIPERACILLIN SODIUM/ TAZOBACTAM SODIUM
(8:1) STERILE LYOPHILIZED
### I II 11/30/2011 LG LIFE SCIENCES LTD MONTELUKAST SODIUM
### A II 12/1/2011 SYMBIOTEC PHARMALAB PRIVATE LTD FLUMETHASONE
### A II 12/1/2011 ALPHORA RESEARCH INC TREPROSTINIL SODIUM
### A II 11/30/2011 SCINOPHARM TAIWAN LTD ENTECAVIR MONOHYDRATE USP
### A II 12/1/2011 HETERO LABS LTD ETRAVIRINE
### I V 12/2/2011 ROTEM INDUSTRIES LTD CASSETTE FOR THE PRODUCTION OF
FLUORINE-18 SODIUM FLUORIDE ON THE
TRACERLAB MX SYNTHESIS UNIT AS
MANUFACTURED IN BEER SHEVA, ISRAEL
### A II 11/9/2011 ZHEJIANG TIANYU PHARMACEUTICAL TELMISARTAN METHYL ESTER
CO LTD
### A IV 12/1/2011 LIPOID GMBH LIPOID SODIUM OLEATE B
### A III 11/28/2011 SUZHOU HAISHUN PACKAGING LAMINATED FILMS AND POUCHES (PET/A1/PE)
MATERIAL CO LTD FOR PHARMACEUTICAL PACKAGING
Page 806
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 11/29/2011 HANGZHOU PLASTICS INDUSTRIAL CO PVC SHEET FOR SOLID PHARMACEUTICAL
LTD PACKAGING
### A II 12/20/2011 GLAND PHARMA LTD DALTEPARIN SODIUM PH.EUR.
### A II 12/5/2011 SHARON BIO MEDICINE LTD NIFEDIPINE USP
### A III 12/1/2011 BORMIOLI PHARMA SPA DROPPER 1.00 MM
### A II 3/15/2012 RELIANCE LIFE SCIENCES PVT LTD PEMETREXED DISODIUM
### A II 12/22/2011 ALCHYMARS ICM SM PRIVATE LTD SODIUM PHENYLBUTYRATE USP
### A II 5/2/2012 NECTAR LIFESCIENCES LTD CEFTRIAXONE SODIUM USP (STERILE) DRUG
SUBSTANCE (PROCESS-II)
### A IV 9/4/2012 NECTAR LIFESCIENCES LTD HARD GELATIN CAPSULE SHELL (PROCESS-II)
### A II 12/7/2011 GLOCHEM INDUSTRIES PRIVATE LTD CARBIDOPA
### A II 11/24/2011 KOTHARI PHYTOCHEMICALS METFORMIN HYDROCHLORIDE USP
INTERNATIONAL
### A II 12/6/2011 COPPERHEAD INVESTMENTS INC SDM® 12, DILUTED NITROGLYCERIN USP
### A IV 12/7/2011 FONA INTERNATIONAL INC 815.086 BUBBLEGUM FLAVOR, NAT
### A II 12/6/2011 HETERO LABS LTD ATAZANAVIR SULFATE
### I II 12/6/2011 NEULAND LABORATORIES LTD MONTELUKAST SODIUM
### A II 2/24/2012 LUPIN LTD FOSAMPRENAVIR CALCIUM
### A II 12/29/2011 NECTAR LIFESCIENCES LTD CEFDINIR USP
### A III 12/5/2011 YAMANI YAKUHIN CO LTD DRYEN SILICA GEL DESICCANT
### A II 12/12/2011 HETERO DRUGS LTD APREPITANT
### A II 12/8/2011 NORAC INC NGT-10100 (Methamphetamine Hydrochloride)
### I II 11/30/2011 SHANDONG FANGMING GLICLAZIDE
PHARMACEUTICAL GROUP CO LTD
### I III 12/5/2011 AMPACET CORP 111818-K BLOMITE 818
### A II 12/9/2011 QILU PHARMACEUTICAL CO LTD DOCETAXEL TRIHYDRATE
### A II 11/28/2011 MYLAN LABORATORIES LTD ILOPERIDONE
### A II 11/29/2011 MYLAN LABORATORIES LTD FOSAMPRENAVIR CALCIUM
### A II 11/30/2011 MYLAN LABORATORIES LTD SEVELAMER HYDROCHLORIDE
### A II 1/11/2012 PAR PHARMACEUTICAL INC PHENOXYBENZAMINE HYDROCHLORIDE USP
### A II 12/12/2011 ALEMBIC PHARMACEUTICALS LTD FAMOTIDINE USP
### A II 8/16/2011 JIANGXI SYNERGY PHARMACEUTICAL CELECOXIB
CO LTD
### I II 10/21/2011 SMILAX LABORATORIES LTD PANTOPRAZOLE SODIUM
### A II 12/23/2011 FERMENTA BIOTECH LTD CHOLECALCIFEROL USP (CRYSTALLINE VITAMIN
D3)
### A III 12/10/2011 GUJARAT FOILS LTD BLISTER FOIL (BARE / COATED / PRINTED
ALUMINIUM FOIL)
### I III 12/7/2011 AMPACET CORP 474974 GREEN PP MB
### A II 12/13/2011 HETERO DRUGS LTD ACYCLOVIR
### A II 3/20/2012 EMCURE PHARMACEUTICALS LTD PROPAFENONE HYDROCHLORIDE USP
### I II 12/21/2011 POLYPEPTIDE LABORATORIES SWEDEN TERLIPRESSIN ACETATE
AB
### A II 1/30/2012 CHEMSPEC API PROCARBAZINE HYDROCHLORIDE
### A III 3/20/2012 SHRIJI POLYMERS INDIA LTD LIQUID MEDICATION DISPENSERS
Page 807
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 11/8/2011 ZHEJIANG CHENG YI PHARMACEUTICAL CAPECITABINE
CO LTD
### A II 12/15/2011 FARMABIOS SPA METHYLTESTOSTERONE (MICRONIZED)
### A II 1/19/2012 SUN PHARMACEUTICAL INDUSTRIES DOXERCALCIFEROL
LTD
### A II 6/6/2012 K+S KALI GMBH POTASSIUM CHLORIDE 99.9% KCI PH. EUR., USP
### A III 11/22/2011 INDIAN EXTRUSIONS POLYPROPYLENE (PP) AND PET BOTTLES WITH
CAPS
### A IV 12/13/2011 CABOT SANMAR LTD CAB-O-SIL M-5P FUMED SILICA
### A II 12/19/2011 HAYASHIBARA CO LTD MALTOSE MONOHYDRATE
### A V 12/16/2011 HAUPT PHARMA WOLFRATSHAUSEN ASEPTIC PROCESS VALIDATION
GMBH
### A III 11/30/2011 FUJIMORI KOGYO CO LTD LAMINATED SHEET FOR USE IN OUTER
PACKAGING OF DRUG PRODUCT
### A III 12/15/2011 KRAIBURG TPE GMBH AND CO KG THERMOLAST M-TM#HET
### A III 12/15/2011 KRAIBURG TPE GMBH AND CO KG THERMOLAST M - TM#MHD
### A III 12/15/2011 KRAIBURG TPE GMBH AND CO KG THERMOLAST M - TM#RST
### A III 12/15/2011 KRAIBURG TPE GMBH AND CO KG THERMOLAST M-TM # ADT
### A II 12/19/2011 WUXI JIDA PHARMACEUTICAL CO LTD RISPERIDONE
### A II 12/13/2011 ZHEJIANG XIANJU PHARMACEUTICAL TESTOSTERONE PROPIONATE NON-STERILE
CO LTD BULK DRUG SUBSTANCE
### A III 12/15/2011 KRAIBURG TPE GMBH AND CO KG THERMOLAST® M TM#LFT
### I II 12/22/2011 SMS PHARMACEUTICALS LTD RANITIDINE HYDROCHLORIDE USP (UNIT-VII)
### A II 10/25/2011 JIANGXI FUSHINE PHARMACEUTICAL CO SULBACTAM
LTD
### I III 12/19/2011 EVONIK INDUSTRIES AG DEGALAN PM 555
25611 I III 12/19/2011 EVONIK INDUSTRIES AG DEGALAN VP 4164 E
### A II 12/22/2011 MEDICHEM MANUFACTURING MALTA MED-200400/M (Desvenlafaxine Succinate)
LTD
### A II 2/12/2011 VITAL LABORATORIES PVT LTD SCOPOLAMINE HYDRO BROMIDE USP
### A II 12/21/2011 HETERO DRUGS LTD FOSAPREPITANT DIMEGLUMINE
### A II 12/20/2011 FARMABIOS SPA BUDESONIDE MICRONIZED STERILE
### I III 12/13/2011 AMPACET CORP 100671 PP UV MB
### A II 12/19/2011 SHANGHAI DESANO CHEMICAL EMTRICITABINE
PHARMACEUTICAL CO LTD
### I II 12/22/2011 NEULAND LABORATORIES LTD PEMETREXED DISODIUM (FORM IV)
### A II 12/16/2011 SOCIETE INDUSTRIELLE DES BXR US REFINED SOYBEAN OIL
OLEAGINEUX
### A II 12/16/2011 SOCIETE INDUSTRIELLE DES BXR US REFINED OLIVE OIL
OLEAGINEUX
### A II 12/22/2011 TEVA PHARMACEUTICAL INDUSTRIES OMEPRAZOLE
LTD
### A II 12/22/2011 EUTICALS SPA ROCURONIUM BROMIDE
### A II 12/22/2011 INKE SA RIZATRIPTAN BENZOATE
Page 808
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/27/2011 MAC CHEM PRODUCTS INDIA PVT LTD DACARBAZINE USP
### I II 12/23/2011 JIANGSU HANSOH PHARMACEUTICAL DULOXETINE HYDROCHLORIDE NON-STERILE
CO LTD BULK DRUG SUBSTANCE
### I II 12/23/2011 JIANGSU HENGRUI MEDICINE CO LTD AZELASTINE HYDROCHLORIDE, NON-STERILE,
BULK DRUG SUBSTANCE
### A III 12/12/2011 THURINGER PHARMAGLAS GMBH AND VIALS AND AMPOULES MADE OF TUBULAR
CO KG GLASS
### I II 12/22/2011 SIEGFRIED USA LLC OXYMORPHONE HYDROCHLORIDE USP (LOW
ABUK IMPURITY)
### A II 12/23/2011 CRYSTAL PHARMA SAU BUDESONIDE MICRONIZED
### A II 12/27/2011 EVERLIGHT CHEMICAL INDUSTRIAL RASAGILINE MESYLATE
CORP
### I II 12/5/2011 HUNAN YUANTONG PHARMACEUTICAL DIOSMIN
CO LTD
### A II 12/13/2011 VITAL LABORATORIES PVT LTD YOHIMBINE HYDROCHLORIDE
### A II 2/15/2012 APICORE US LLC CLOFARABINE
### A II 12/27/2011 SCINOPHARM TAIWAN LTD BIVALIRUDIN
### A III 11/20/2011 VIVEK POLYMER INDIA PLASTIC BOTTLES AND CLOSURES
### A II 12/28/2011 RAKS PHARMA PVT LTD CELECOXIB, USP
### A II 12/29/2011 HETERO DRUGS LTD FEXOFENADINE HYDROCHLORIDE
### A II 12/29/2011 ZAKLADY FARMACEUTYCZNE IBANDRONATE SODIUM MONOHYDRATE
POLPHARMA SA
### A II 12/29/2011 MYLAN LABORATORIES LTD SEVELAMER CARBONATE
### A II 12/27/2011 SUZHOU LIXIN PHARMACEUTICAL CO PEMETREXED DISODIUM (NON STERILE)
LTD
### I II 12/28/2011 QILU PHARMACEUTICAL CO LTD ADEFOVIR DIPIVOXIL (NON STERILE, API)
### A II 12/28/2011 MEGAFINE PHARMA P LTD PALIPERIDONE USP (NON- STERILE DRUG
SUBSTANCE)
### A III 1/3/2012 HUHTAMAKI FLEXIBLE PACKAGING FILM WRAPPER FOR TRANSDERMAL PATCHES
GERMANY GMBH AND CO KG
### A II 12/29/2011 CHEMWERTH INC MELPHALAN HCL, NON-STERILE, BULK DRUG
SUBSTANCE
### A IV 12/27/2011 IDEAL CURES PVT LTD ECOPOL ACRYLIC PHARMA POLYMERS
### I II 2/16/2012 CADILA HEALTHCARE LTD SALMETEROL XINAFOATE USP
### A II 2/21/2012 CADILA HEALTHCARE LTD ETHACRYNIC ACID USP
### A II 12/30/2011 RAKS PHARMA PVT LTD RABEPRAZOLE SODIUM USP
### I II 1/16/2012 SUN PHARMACEUTICAL INDUSTRIES FOSAMPRENAVIR CALCIUM
LTD
### A II 1/10/2012 AUROBINDO PHARMA LTD RALOXIFENE HYDROCHLORIDE USP (NON-
STERILE DRUG SUBSTANCE)
### A II 12/30/2011 MYLAN LABORATORIES LTD PRASUGREL HYDROCHLORIDE
### A II 12/30/2011 MYLAN LABORATORIES LTD DESMOPRESSIN ACETATE USP
### A II 12/30/2011 MYLAN LABORATORIES LTD EZETIMIBE USP
### A II 1/3/2012 TEVA PHARMACEUTICAL INDUSTRIES LOSARTAN POTASSIUM
LTD
Page 809
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 12/30/2011 INTERNATIONAL CONVERTER LLC FLEXIBLE PACKAGING FOR PHARMACEUTICAL
APPLICATIONS
### A II 1/13/2012 WOCKHARDT LTD DESVENLAFAXINE SUCCINATE MONOHYDRATE
### I II 2/20/2012 SUN PHARMACEUTICAL INDUSTRIES ATORVASTATIN CALCIUM (AMORPHOUS)
LTD
### A II 12/30/2011 ZHEJIANG HISUN PHARMACEUTICAL CO MITOMYCIN USP (ALTERNATIVE PROCESS)
LTD
### I II 3/23/2012 IPCA LABORATORIES LTD ESCITALOPRAM OXALATE
### A II 3/27/2012 IPCA LABORATORIES LTD TRIMETHOPRIM USP
### A II 1/3/2012 TORRENT PHARMACEUTICALS LTD REPAGLINIDE
### I II 12/10/2010 ALP PHARM BEIJING CO LTD FEBUXOSTAT
### A II 12/30/2011 SCINOPHARM TAIWAN LTD BORTEZOMIB
### A II 12/22/2011 CHONGQING KANGLE CILOSTAZOL USP
PHARMACEUTICAL CO LTD
### A II 2/2/2012 CHEMWERTH INC BUSULFAN USP NON-STERILE BULK DRUG
### A II 2/16/2012 UNIMARK REMEDIES LTD DRONEDARONE HYDROCHLORIDE
### A II 1/17/2012 SRI KRISHNA PHARMACEUTICALS LTD BUTORPHANOL TARTRATE USP
### I III 12/28/2011 H AND H GLASS INC AMBER AND FLINT GLASS
### A II 1/4/2012 SAMYANG BIOPHARMACEUTICALS DOCETAXEL ANHYDROUS
CORP
### A II 4/10/2012 LUNDBECK PHARMACEUTICALS ITALY ETHOTOIN
SPA
### A IV 12/30/2011 ILE PHARMACEUTICAL MATERIALS CO ENTERIC FILM COATING SYSTEMS
LTD
### A II 1/4/2012 DIPHARMA FRANCIS SRL RUFINAMIDE USP
### A II 1/4/2012 DIPHARMA FRANCIS SRL DICLOFENAC EPOLAMINE
### A II 1/4/2012 SAMYANG BIOPHARMACEUTICALS DOCETAXEL TRIHYDRATE
CORP
### I II 1/5/2012 DAEWOONG BIO INC STERILE MEROPENEM
### I II 1/5/2012 DAEWOONG BIO INC IOPROMIDE
### I II 1/3/2012 JARI PHARMACEUTICAL CO LTD OXALIPLATIN
### A II 1/6/2012 MSN LABORATORIES PRIVATE LTD FOSAPREPITANT DIMEGLUMINE [ROUTE CODE -
"FD"]
### A II 12/22/2011 ICROM SPA RISPERIDONE
### A V 1/6/2012 DURECT CORP SUCROSE ACETATE ISOBUTYRATE (SAIB)
### A II 12/20/2011 ZHEJIANG HUAHAI PHARMACEUTICAL ARIPIPRAZOLE USP
CO LTD
### A II 1/9/2012 HETERO LABS LTD IRINOTECAN HYDROCHLORIDE TRIHYDRATE,
USP (FORM B)
### I II 1/2/2012 POLYDRUG LABORATORIES PVT LTD CARISOPRODOL
### A III 1/6/2012 OREM ACCESS BIO INC MOISTURE AND ODOUR REGULATING
PRODUCTS
### A III 12/20/2011 SIBO G DOO CLOSURES SIBO
### I IV 1/9/2012 FONA INTERNATIONAL INC PRODUCT # 889.0069U PEACH FLAVOR, NAT
WONF
Page 810
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 1/10/2012 LIPOID GMBH LIPOID PE 16:0/16:0-PEG 5000 (MPEG 5000-
DPPE)
### A III 1/3/2012 ADHESIVES RESEARCH INC MA-69 (R-9667)
### I II 1/4/2012 AVRA LABORATORIES PRIVATE LTD IRINOTECAN HYDROCHLORIDE USP
### A II 1/18/2012 AUROBINDO PHARMA LTD TADALAFIL USP (NON-STERILE DRUG
SUBSTANCE)
### I II 5/15/2012 ENALTEC LABS PRIVATE LTD DALFAMPRIDINE
### I II 3/20/2012 USV LTD COLESEVELAM HYDROCHLORIDE
### I II 12/30/2011 SHANDONG KEXING BIOPRODUCTS CO RECOMBINANT HUMAN GRANULOCYTE
LTD COLONY-STIMULATING FACTOR
### I II 12/30/2011 SHANDONG KEXING BIOPRODUCTS CO RECOMBINANT HUMAN ERYTHROPOIETIN
LTD
### A IV 1/10/2012 CELANESE EVA PERFORMANCE ETHYLENE VINYL ACETATE COPOLYMER,
POLYMERS VITALDOSE® K2390.X01
### A II 1/9/2012 FORMOSA LABORATORIES INC LINEZOLID
### A II 1/9/2012 FORMOSA LABORATORIES INC ULIPRISTAL ACETATE
### I III 1/9/2012 GREINER PACKAGING GMBH 250ML AND 950 ML PLASTIC BOTTLE INTENDED
FOR PACKAGING ORAL SOLID DOSAGE FORMS
### A II 4/9/2012 BIOCON LTD TRAVOPROST USP DRUG SUBSTANCE
### I IV 10/22/2011 FONA INTERNATIONAL INC 856.061 GRAPE FLAVOR, ARTIFICIAL
### A II 1/9/2012 QILU ANTIBIOTICS LINYI TERBINAFINE HYDROCHLORIDE (NON STERILE,
PHARMACEUTICAL CO LTD API)
### I II 12/29/2011 KYONGBO PHARMACEUTICAL CO LTD MEROPENEM STERILE, BULK
### A II 12/20/2011 ZHEJIANG HUAHAI PHARMACEUTICAL VORICONAZOLE USP
CO LTD
### A IV 1/16/2012 CELANESE EVA PERFORMANCE ETHYLENE VINYL ACETATE COPOLYMER,
POLYMERS VITALDOSE® K2389.X01
### I II 1/9/2012 SHANGHAI ZHONGXI SUNVE HYDROXYCHLOROQUINE SULFATE (USP)
PHARMACEUTICAL CO LTD
### I II 12/29/2011 KYONGBO PHARMACEUTICAL CO LTD CEFTAZIDIME STERILE, BULK
25711 A II 2/18/2012 MACLEODS PHARMACEUTICALS LTD RABEPRAZOLE SODIUM
### A II 1/18/2012 HETERO DRUGS LTD OMEPRAZOLE, USP (FORM B)
### A II 1/5/2012 MSN ORGANICS PRIVATE LTD TOPIRAMATE USP [ROUTE CODE - "TI"]
### A II 1/16/2012 SHANDONG NEW TIME POTASSIUM CLAVULANATE, DILUTED WITH
PHARMACEUTICAL CO LTD SILICON DIOXIDE IN THE RATIO 1:1
### I II 1/17/2012 VIWIT PHARMACEUTICAL CO LTD APREPITANT (DRUG SUBSTANCE, NON-STERILE)
### A II 1/14/2012 QILU ANTIBIOTICS PHARMACEUTICAL STERILE CEFAZOLIN SODIUM PROCESS 1 BULK
CO LTD ANTIBIOTIC DRUG SUBSTANCE
### A II 2/23/2012 COSMA SPA MILNACIPRAN HYDROCHLORIDE
### A II 1/16/2012 SHANDONG NEW TIME CLAVULANATE POTASSIUM
PHARMACEUTICAL CO LTD
### A II 1/16/2012 SHANDONG NEW TIME POTASSIUM CLAVULANATE, DILUTED WITH
PHARMACEUTICAL CO LTD MICROCRYSTALLINE CELLULOSE IN THE RATIO
1:1
Page 811
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 1/19/2012 APOTEX PHARMACHEM INDIA PVT LTD CAPECITABINE USP
### A II 12/20/2011 ZHEJIANG HUAHAI PHARMACEUTICAL CARVEDILOL DIHYDROGEN PHOSPHATE
CO LTD HEMIHYDRATE USP
### A III 1/11/2012 HANGZHOU PLASTICS INDUSTRIAL CO PP/A1/PVC/PVDC COMPOSITE SHEET FOR
LTD SOLID PHARMACEUTICAL PACKAGING
### A III 1/11/2012 HANGZHOU PLASTICS INDUSTRIAL CO PVC/PVDC COMPOSITE SHEET FOR SOLID
LTD PHARMACEUTICAL PACKAGING
### A III 1/11/2012 HANGZHOU PLASTICS INDUSTRIAL CO PVC/PE/PVDC COMPOSITE SHEET FOR SOLID
LTD PHARMACEUTICAL PACKAGING
### A III 12/10/2011 GUJARAT FOILS LTD STRIP FOIL
(BARE/COATED/LAMINATED/PRINTED/ALUMINUM
FOIL)
### A II 1/25/2012 CHENG FONG CHEMICAL CO LTD 4-PHENYLBUTYRIC ACID SODIUM SALT
### A II 3/26/2012 LUPIN LTD DESVENLAFAXINE BENZOATE
### A II 1/19/2011 BIOCON LTD HYDROXY ECHINOCANDIN
### I IV 1/23/2012 FONA INTERNATIONAL INC 825.527 N-C CHERRY FLAVOR, ARTIFICIAL
### A II 1/24/2012 MSN LABORATORIES PRIVATE LTD BICALUTAMIDE USP [ROUTE CODE - "BL"]
### A II 1/25/2012 NIPPON SHINYAKU CO LTD NS-018 A DRUG SUBSTANCE
### A III 1/19/2012 ADVANCED SCIENTIFICS INC POLYETHLENE BAGS AND TRANSFER TUBE
ASSEMBLIES
### A II 1/26/2012 NEULAND LABORATORIES LTD DEFERASIROX
### A II 3/8/2012 DR REDDYS LABORATORIES LTD ZOLMITRIPTAN (PROCESS-II)
### I II 1/26/2012 BACHEM SA ZIPRASIDONE HCL
### A II 1/24/2012 BCN PEPTIDES SA VASOPRESSIN
### I II 12/20/2011 ZHEJIANG HUAHAI PHARMACEUTICAL LOSARTAN POTASSIUM
CO LTD
### A II 2/7/2012 WISDOM PHARMACEUTICAL CO LTD BENAZEPRIL HYDROCHLORIDE
### A IV 1/10/2012 TAKASAGO INTERNATIONAL CORP ORANGE FLAVOR OT-42107
### A II 1/26/2012 POLYMED THERAPEUTICS INC BORTEZOMIB DRUG SUBSTANCE
### A IV 1/28/2012 TOAGOSEI CO LTD POLYACRYLATE POLYMERS- ARONVIS AH-105,
AH-105X, AH-105XX, AH-106X, MX, SX, AND
JURYMER AC-10H
### A II 1/25/2012 SIGNA SA DE CV TELMISARTAN USP/EP
### I II 6/18/2012 JUHUA GROUP CORP PHARMACEUTICAL DIFLUNISAL USP
FACTORY
### A II 2/23/2012 EMCURE PHARMACEUTICALS LTD MYCOPHENOLATE MOFETIL USP
### A II 3/26/2012 DR REDDYS LABORATORIES LTD ASENAPINE MALEATE
### I II 1/31/2012 APOTEX PHARMACHEM INDIA PVT LTD MYCOPHENOLATE MOFETIL USP
### I II 1/30/2012 TEVA PHARMACEUTICAL INDUSTRIES DESVENLAFAXINE SUCCINATE HPMC
LTD PRELIMINARY MIX
### A II 1/30/2012 BLUE ZONE TECHNOLOGIES LTD DESFLURANE USP
### A II 1/30/2012 TEVA PHARMACEUTICAL INDUSTRIES DESVENLAFAXINE SUCCINATE
LTD
### A II 3/20/2012 EMCURE PHARMACEUTICALS LTD NISOLDIPINE
### A II 2/24/2012 LUPIN LTD DESVENLAFAXINE SUCCINATE
Page 812
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 2/10/2012 PAN DRUGS LTD GUAIFENESIN USP
### A II 4/2/2012 LUPIN LTD RALTEGRAVIR POTASSIUM
### I IV 2/3/2012 FONA INTERNATIONAL INC 856.485 N-C GRAPE FLAVOR, ART
### A IV 1/10/2012 JUKU ORCHEM PRIVATE LTD MICROCRYSTALLINE CELLULOSE USP
### I III 2/1/2012 DA PRO RUBBER INC DPXB433-5
### A III 2/27/2012 SANNER GMBH DESICCANT CARTRIDGES
### A II 2/3/2012 PFANSTIEHL INC PODOPHYLLOTOXIN (P-126)
### I II 1/18/2012 JIANGSU YEW PHARMACEUTICAL CO PACLITAXEL
LTD
### I II 2/3/2012 LIFECORE BIOMEDICAL LLC SODIUM HYALURONATE POWDER,
SPECIFICATION LPD-9800037, PH 4.0 PROCESS
### A II 2/24/2012 UNIMARK REMEDIES LTD FEBUXOSTATE
### A II 2/8/2012 AMOLI ORGANICS PVT LTD LEVETIRACETAM USP [ROUTE CODE - LVS]
### A II 3/19/2012 EMCURE PHARMACEUTICALS LTD IBUTILIDE FUMARATE USP
### A II 3/20/2012 EMCURE PHARMACEUTICALS LTD RIZATRIPTAN BENZOATE USP
### A II 3/19/2012 EMCURE PHARMACEUTICALS LTD ARGATROBAN USP
### A II 7/25/2012 SPECGX LLC HYDROMORPHONE HYDROCHLORIDE USP (NP)
### A II 5/5/2012 NECTAR LIFESCIENCES LTD CEFEPIME FOR INJECTION USP (STERILE BULK)
DRUG SUBSTANCE
### A II 3/27/2012 UQUIFA MEXICO SA DE CV ALBENDAZOLE
### A II 4/2/2012 CADILA HEALTHCARE LTD BOSENTAN MONOHYDRATE
### A II 5/17/2012 CADILA HEALTHCARE LTD FESOTERODINE FUMARATE
### I III 3/22/2012 AMPACET CORP 432619 YELLOW PP MB
### A II 3/28/2012 INDUSTRIALE CHIMICA SRL BRINZOLAMIDE, USP
### I III 3/22/2012 AMPACET CORP 454113 RED PP MP
### A III 3/22/2012 AMPACET CORP 474268 GREEN PP MB
### I III 3/22/2012 AMPACET CORP 463728 BLUE PP MB
### A III 3/21/2012 AMERICHEM INC 61918-CD1 WHITE COLORANT
### A III 3/28/2012 SYMETAL ALUMINIUM FOIL INDUSTRY SA LACQUERED BLISTER FOIL 20 - 30 MICRONS
### A II 3/30/2012 PATHEON API MANUFACTURING INC LATANOPROST
Page 817
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 3/27/2012 MEITEK TECHNOLOGY QINGDAO CO LTD CHONDROITIN SULFATE CALCIUM
Page 818
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 3/1/2012 HUNAN YUXIN PHARMACEUTICAL CO MOMETASONE FUROATE
LTD
### A IV 4/10/2012 FONA INTERNATIONAL INC 926.0701U FONATECHr VANILLA FLAVOR, NAT
(CFT)
### A III 3/1/2012 EASTMAN CHEMICAL CO EASTMAN® 168 NON-PHTHALATE PLASTICIZER
PRODUCTION
### A II 10/31/2013 SPECGX LLC HYDROCODONE BITARTRATE USP CRYSTALS
(NP)
### A II 3/6/2012 SWATI SPENTOSE PRIVATE LTD LIDOCAINE HYDROCHLORIDE USP
### A II 3/27/2012 PARABOLIC DRUGS LTD DEFERASIROX
### A III 4/12/2012 SEKISUI ALVEO AG ALVEOLITr TA SRZ POLYMER FOAMS
### A IV 4/10/2012 ILE PHARMACEUTICAL MATERIALS CO COMPLETE FILM COATING SYSTEMS
LTD
### A IV 4/12/2012 SYMRISE INC 910009 EVOSPRAY NATURAL LIME FLAVOR
WONF
### I II 3/15/2012 QILU TIANHE PHARMACEUTICAL CO LTD TAZOBACTAM ACID (PROCESS V, NON-STERILE
API)
### A III 4/2/2012 SEKISUI ALVEO AG ALVEOLITr TL SRZ
### A II 4/12/2012 INCELL CORP LLC ZSOL:F, ZSOL:M AND ZSOL:MH BIOPROCESSING
BUFFER FAMILY
### A III 4/10/2012 SCG PERFORMANCE CHEMICALS CO POLYPROPYLENE EL-PRO P655IM
LTD
### A II 4/16/2012 OLON SPA ETHACRYNIC ACID
### A III 4/17/2012 JAPAN POLYPROPYLENE CORP NOVATEC/WELNEX/WINTEC PP SERIES
### A IV 4/10/2012 HENRY H OTTENS MANUFACTURING CO ARTIFICIAL CHERRY FLAVOR #5578
INC
### A II 4/23/2012 AUROBINDO PHARMA LTD PALONOSETRON HYDROCHLORIDE (NON-
STERILE DRUG SUBSTANCE)
### A V 4/17/2012 ACS DOBFAR SPA STERILE FINISHED PRODUCTS AND STERILE
PROCESSING OPERATION
### A II 5/16/2012 RELIANCE LIFE SCIENCES PVT LTD ERLOTINIB HYDROCHLORIDE
### A IV 5/5/2012 SUNIL HEALTHCARE LTD EMPTY HARD GELATIN CAPSULES
### A II 4/16/2012 SYN-TECH CHEM AND PHARM CO LTD GRANISETRON BASE
### A III 4/13/2012 NOLATO JAYCARE LTD 60, 75 AND 100ML HDPE WHITE ROUND
BOTTLES
### I II 4/18/2012 ZHEJIANG GUOBANG PHARMACEUTICAL CLARITHROMYCIN USP
CO LTD
### I II 4/19/2012 CHEMI SPA ZOLEDRONIC ACID HEMIPENTAHYDRATE
### I IV 4/23/2012 BHARAT STARCH INDUSTRIES SODIUM STARCH GLYCOLATE USP
### A II 4/20/2012 ST GOBAIN PERFORMANCE PLASTICS SANI-TECH® ULTRA 65 SILICONE TUBING
CORP
### A II 4/20/2012 RA CHEM PHARMA LTD ITRACONAZOLE USP
### A II 4/23/2012 HOVIONE FARMACIENCIA SA MOMETASONE FUROATE MONOHYDRATE
INHALATION GRADE
### A II 4/23/2012 CQ INTERNATIONAL CO INC DECITABINE
Page 819
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 4/13/2012 CAMBREX PROFARMACO MILANO SRL EPINEPHRINE
### I III 4/25/2012 MPI RELEASE RELEASE LINER 2-MIL PET C1S 15-0121
### A IV 4/20/2012 CORDEN PHARMA CHENOVE SODIUM STEARYL FUMARATE
### A II 4/28/2012 ZHEJIANG HISUN PHARMACEUTICAL CO FLUVASTATIN SODIUM USP
LTD
### A II 5/7/2012 SRI KRISHNA PHARMACEUTICALS LTD GLIPIZIDE USP
### A III 4/25/2012 MITSUI CHEMICALS INC APEL APL6011T, APL6013T, APL6015T, APL6509T,
AND APL8008T
### A II 4/24/2012 ZHEJIANG JINHUA CONBA BIO PHARM ARIPIPRAZOLE
CO LTD
### A III 4/23/2012 LOPAREX INDIA PVT LTD RELEASE LINERS GRADE XL-TDP 62 YELLOW
MADE WITH PLATINUM CURE CHEMISTRY ON
YELLOW GLASSINE
### A III 4/23/2012 LOPAREX INDIA PVT LTD RELEASE LINERS GRADE XL-TDP 62 WHITE
MADE WITH PLATINUM CURE CHEMISTRY ON
WHITE GLASSINE
### A III 4/23/2012 LOPAREX INDIA PVT LTD RELEASE LINERS GRADE XL-TDP 80 MADE WITH
PLATINUM CURE CHEMISTRY ON GLASSINE
PAPER
### A III 4/23/2012 LOPAREX INDIA PVT LTD RELEASE LINERS GRADE XL-TDP 90 MADE WITH
PLATINUM CURE CHEMISTRY ON GLASSINE
PAPER
### A III 4/23/2012 LOPAREX INDIA PVT LTD RELEASE LINERS GRADE XL-TDP 120 MADE
WITH PLATINUM CURE CHEMISTRY ON
GLASSINE PAPER
### I III 4/24/2012 AMPACET CORP 455899 RED SMC PP MB
### I II 4/19/2012 BACHEM SA DEFERASIROX
### A II 4/20/2012 PIRAMAL ENTERPRISES LTD SULINDAC
### I II 8/12/2012 SUZHOU APAC PHARMATECH CO LTD EWJPB, API
### I V 5/25/2013 HALOZYME THERAPEUTICS INC PRE-CLINICAL AND LABORATORY INFORMATION
(RHUPH20)
### A III 4/27/2012 CONSOLIDATED BOTTLE CORP 20ML NATURAL EUROPEAN DOSAGE CUP PP
ROUND, GRADUATED (2.5ML TO 20ML)
### A III 4/25/2012 CLARIANT HEALTHCARE PACKAGING SORB-IT PACKETS
(FRANCE)
### A II 3/21/2012 QILU TIANHE PHARMACEUTICAL CO LTD PIPERACILLIN SODIUM AND TAZOBACTAM
SODIUM (8:1) (STERILE API)
### A III 4/11/2012 CHROMA CORP PC85234B BLACK COLOR CONCENTRATE
### A II 6/1/2012 APICORE US LLC ETHACRYNIC ACID USP
### A III 5/1/2012 BOEHRINGER INGELHEIM PHARMA CONTAINER CLOSURE FOR RESPIMAT®
GMBH AND CO KG AQUEOUS SOLUTIONS
### A III 5/1/2012 BOEHRINGER INGELHEIM MICROPARTS RESPIMAT® INHALER FOR AQUEOUS
GMBH SOLUTIONS
### A II 4/30/2012 CERBIOS PHARMA SA (6S)-5-METHYLTETRAHYDROFOLIC ACID
CALCIUM SALT
Page 820
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 5/2/2012 HETERO DRUGS LTD RIZATRIPTAN BENZOATE USP
### A II 7/13/2012 SUN PHARMACEUTICAL INDUSTRIES CAPECITABINE USP
LTD
### I II 5/22/2012 FRESENIUS KABI ONCOLOGY LTD TEMSIROLIMUS
### A II 5/2/2012 SYMBIOTEC PHARMALAB PRIVATE LTD ETHINYL ESTRADIOL, USP (MICRONIZED)
### A II 5/2/2012 SYMBIOTEC PHARMALAB PRIVATE LTD ETHYNODIOL DIACETATE, USP (MICRONIZED)
### A II 4/28/2012 ZHEJIANG NEO DANKONG ATORVASTATIN CALCIUM, NON-STERILE BULK
PHARMACEUTICAL CO LTD DRUG SUBSTANCES
### A II 4/25/2012 MYLAN LABORATORIES LTD DRONEDARONE HYDROCHLORIDE
### A II 5/3/2012 MSN LABORATORIES PRIVATE LTD ESMOLOL HYDROCHLORIDE USP [ROUTE
CODE-"EH"]
### A II 4/20/2012 AVRA LABORATORIES PRIVATE LTD 10-HYDROXYCAMPTOTHECIN
### A II 5/8/2012 PROTEUS SA NEOSAXITOXIN 200æG/ML
### I II 4/25/2012 KONDUSKAR LABORATORIES PVT LTD OXCARBAZEPINE USP
### A II 5/5/2012 DIVIS LABORATORIES LTD TELMISARTAN, USP
### A II 5/8/2012 MAC CHEM PRODUCTS INDIA PVT LTD CARBOPLATIN USP
### A II 5/8/2012 LIVZON GROUP FUZHOU FUXING VANCOMYCIN HYDROCHLORIDE, LYOPHILIZED
PHARMACEUTICAL CO LTD
### A II 4/27/2012 KREATIVE ORGANICS PRIVATE LTD SALSALATE
### A II 8/16/2012 EXCELLA GMBH AND CO KG TEMOZOLOMIDE
### A II 5/23/2012 IPCA LABORATORIES LTD CETIRIZINE HYDROCHLORIDE USP (CZ5
PROCESS)
### I III 11/15/2010 INGENIA POLYMERS CORP INGENIA POLYMERS 1023 FILLED WHITE
### A II 6/1/2012 AUROBINDO PHARMA LTD OLMESARTAN MEDOXOMIL USP
### A III 5/4/2012 LEVOSIL SPA DESICCANT BAGS
### I II 5/7/2012 JIANGSU HENGRUI MEDICINE CO LTD MESNA USP, NON-STERILE, BULK DRUG
SUBSTANCE
### A II 5/9/2012 NEULAND LABORATORIES LTD BOSENTAN MONOHYDRATE
### A II 5/7/2012 BLOOMAGE FREDA BIOPHARM CO LTD SODIUM HYALURONATE (HA-P-0.5)
### A IV 5/8/2012 SYMRISE INC 992583 NATURAL PEPPERMINT FLAVOR
POWDER 605030
### A II 5/11/2012 JIANGSU HENGRUI MEDICINE CO LTD CYCLOPHOSPHAMIDE, USP, STERILE, BULK
DRUG SUBSTANCE
### A II 5/8/2012 RAKS PHARMA PVT LTD LINEZOLID USP
### A II 1/31/2013 CHONGQING SHENGHUAXI FEBUXOSTAT
PHARMACEUTICAL CO LTD
### A II 5/15/2012 HETERO LABS LTD ETORICOXIB
### I II 5/15/2012 HETERO DRUGS LTD ZIPRASIDONE HYDROCHLORIDE, USP
### I IV 5/3/2012 FRUTAROM USA NATURAL & ARTIFICIAL BLACKBERRY FLAVOR
3251351091.00
### A II 6/8/2012 UNIMARK REMEDIES LTD CEFIXIME USP
### A II 5/23/2012 ZHEJIANG HISUN PHARMACEUTICAL CO SIMVASTATIN (BHA ADDED) USP
LTD
### A II 6/14/2012 ZHEJIANG HISUN PHARMACEUTICAL CO DEMECLOCYCLINE HYDROCHLORIDE USP
LTD
Page 821
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 7/20/2012 ZHEJIANG HISUN PHARMACEUTICAL CO MINOCYCLINE HYDROCHLORIDE USP
LTD
### A III 4/23/2012 SHREE NAINA POLYMERS INC PET BOTTLES
### A II 5/14/2012 SIEGFRIED LTD BUPRENORPHINE
### A III 4/25/2012 SUN PACKMET PRIVATE LTD PLAIN/PRINTED ALUMINIUM FOILS
(STRIP/BLISTER)
### I IV 5/16/2012 CAPSUGEL MANUFACTURING INC COMPLIANCE IDENTIFIER CAPSULES
### A V 7/27/2012 ENTERIS BIOPHARMA INC 3-O-LAUROYL-L-CARNITINE HYDROCHLORIDE
(LLC)
### A II 8/31/2012 PRONOVA BIOPHARMA NORGE AS OMEGA-3-ACID ETHYL ESTERS
### A IV 5/14/2012 WILSHIRE TECHNOLOGIES INC PHYTOSQUENE®
### I III 4/23/2012 SHREE NAINA PACKWELL INC GLASS AMPOULES AND VIALS
### A II 5/25/2012 AMPHASTAR NANJING SEMI-PURIFIED HEPARIN SODIUM
PHARMACEUTICALS INC
### A V 5/15/2012 ACS DOBFAR SPA STERILE FINISHED PRODUCTS AND STERILE
PROCESSING OPERATIONS
### A II 5/9/2012 QILU PHARMACEUTICAL CO LTD EXEMESTANE (NON-STERILE, API)
### I II 5/2/2012 KOPRAN LTD PREGABALIN
### A II 5/17/2012 ZHEJIANG JIUZHOU PHARMACEUTICAL LCA45
CO LTD
### I II 5/19/2012 INDO PHYTO CHEMICALS PRIVATE LTD LEVONORGESTREL USP
### A II 5/11/2012 PIRAMAL ENTERPRISES LTD APREPITANT
### I II 5/15/2012 NORTH CHINA PHARMACEUTICAL AMOXICILLIN TRIHYDRATE (NON STERILE, API)
GROUP SEMISYNTECH CO LTD
### A II 5/18/2012 MAPRIMED SA ZOLEDRONIC ACID MONOHYDRATE (CODE
50787)
### A II 5/17/2012 TEVA PHARMACEUTICAL INDUSTRIES EZETIMIBE DRUG SUBSTANCE
LTD
### I IV 4/26/2012 TIANJIN KAIWEI AND YONGLI UNITED WHITE MINERAL OIL
CHEMICAL CO LTD
### A II 6/15/2012 INTERNATIONAL MEDICATION SYSTEMS HEPARIN SODIUM USP
LTD
### A II 5/31/2012 CADILA HEALTHCARE LTD FEBUXOSTAT API
### A II 7/2/2012 CADILA HEALTHCARE LTD OLANZAPINE USP
### A II 5/31/2012 CADILA HEALTHCARE LTD ROSUVASTATIN CALCIUM USP
### A II 5/22/2012 HETERO DRUGS LTD MOXIFLOXACIN HYDROCHLORIDE
### A II 5/18/2012 CHEMWERTH INC ARSENIC TRIOXIDE, NON-STERILE, BULK DRUG
SUBSTANCE
### A II 5/21/2012 SOLARA A PHARMA SCIENCES LTD PRAZIQUANTEL
### A II 6/13/2012 TEVA PHARMACEUTICAL INDUSTRIES OXYBUTYNIN BASE
LTD
### A II 5/22/2012 MSN LABORATORIES PRIVATE LTD CAPECITABINE USP [ROUTE CODE - "CT"]
### A II 5/23/2012 HETERO DRUGS LTD VALGANCICLOVIR HYDROCHLORIDE, USP
### A II 5/22/2012 HETERO DRUGS LTD FENOFIBRATE, USP
### A II 5/14/2012 CAYMAN PHARMA SRO LATANOPROST
Page 822
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 5/18/2012 NAGAOKA AND CO LTD MENTHA OIL JP
### A II 5/24/2012 SOLARA A PHARMA SCIENCES LTD TENOFOVIR DISOPROXIL FUMARATE
### A II 5/22/2012 RAKS PHARMA PVT LTD ATORVASTATIN CALCIUM STABILIZED
### A II 6/28/2012 GLENMARK PHARMACEUTICALS LTD DRONEDARONE HYDROCHLORIDE
### I II 5/24/2012 SIGMA ALDRICH MANUFACTURING LLC HYALURONIDASE
### A II 5/23/2012 RAKS PHARMA PVT LTD DEXLANSOPRAZOLE API
### A II 5/16/2012 ZHEJIANG JIANGBEI PHARMACEUTICAL SIMVASTATIN AMMONIUM SALT (ALTERNATIVE
CO LTD PROCESS)
### A III 5/21/2012 SMITHS MEDICAL ASD INC ENTERAL MEDICATION CASSETTE RESERVOIR
### A III 5/30/2012 LUXFER GAS CYLINDERS COMPRESSED GAS CYLINDER PACKAGE
(ALTERNATIVE PROCESS)
### A II 12/30/2013 HUBEI HONCH PHARMACEUTICAL CO VINORELBINE TARTRATE
LTD
### A IV 4/23/2012 GC CHEMIE PHARMIE LTD NOVOCOAT - HYPROMELLOSE USP-34
### A IV 4/23/2012 GC CHEMIE PHARMIE LTD NOVODONE-CR CROSPOVIDONE USP-34
### A IV 4/23/2012 GC CHEMIE PHARMIE LTD NOVODONE POVIDONE USP-34
### A III 5/30/2012 JIANGSU HUALAN NEW BUTYL RUBBER STOPPERS COVERED WITH
PHARMACEUTICAL MATERIAL CO LTD POLYSTER FILMS
### A III 5/22/2012 BORMIOLI PHARMA SPA SPECIAL CHILD-PROOF CP O28 MM
### A II 5/26/2012 ZHEJIANG TIANYU PHARMACEUTICAL MONTELUKAST BACKONE DIOL
CO LTD
### A II 6/8/2012 MEIJI SEIKA PHARMA CO LTD ARBEKACIN FREE BASE DRUG SUBSTANCE
(ME1100)
### A II 5/30/2012 HETERO DRUGS LTD ELETRIPTAN HYDROBROMIDE
### I II 5/30/2012 HETERO DRUGS LTD SEVELAMER HYDROCHLORIDE
### A II 5/18/2012 BIOCON LTD ORLISTAT
### A II 9/7/2012 AUROBINDO PHARMA LTD ESOMEPRAZOLE SODIUM (NON-STERILE DRUG
SUBSTANCE)
### A II 11/28/2012 TARO PHARMACEUTICAL INDUSTRIES PROGUANIL HYDROCHLORIDE USP
LTD
### A II 5/30/2012 OLON SPA ASENAPINE MALEATE
### A II 9/30/2012 EMCURE PHARMACEUTICALS LTD ZOLMITRIPTAN
### A III 5/15/2012 EQUISTAR CHEMICALS LP A POLYPROPYLENE RESINS FOR MEDICAL
LYONDELLBASELL INDUSTRIES CO APPLICATIONS
### A II 5/31/2012 HUBEI HAOSUN PHARMACEUTICAL CO OXALIPLATIN
LTD
### A II 5/31/2012 CATALENT PHARMA SOLUTIONS LLC WC3042-08P CAPSULE
### A II 5/30/2012 MINSHENG GROUP SHAOXING ALENDRONATE SODIUM
PHARMACEUTICAL CO LTD
26110 A II 5/31/2012 CATALENT PHARMA SOLUTIONS LLC WC3042-05, CAPSULE
26111 I II 5/29/2012 ZHUHAI UNITED LABORATORIES CO LTD POTASSIUM CLAVULANATE -
MICROCRYSTALLINE CELLULOSE (1:1)
26112 A II 5/31/2012 CAMBREX CHARLES CITY INC DICLOFENAC EPOLAMINE
26113 A II 6/4/2012 HETERO DRUGS LTD TETRABENAZINE
26114 I II 5/28/2012 ZHUHAI UNITED LABORATORIES CO LTD CEFUROXIME SODIUM USP
Page 823
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
26115 I II 5/28/2012 ZHUHAI UNITED LABORATORIES CO LTD CEFOPERAZONE SODIUM USP
26116 A II 6/4/2012 HETERO LABS LTD ERLOTINIB HYDROCHLORIDE
26117 A II 5/30/2012 MYLAN LABORATORIES LTD ADEFOVIR DIPIVOXIL
26118 A III 6/1/2012 KYODO PRINTING CO LTD MOISTCATCH SERIES FOR MOISTURE
ABSORBING MATERIAL
26119 A IV 6/1/2012 THE NIPPON SYNTHETIC CHEMICAL GOHSENOL EG
INDUSTRY CO LTD
### I IV 6/1/2012 FONA INTERNATIONAL INC 825.0047U CHERRY FLAVOR, NAT WONF
### A II 6/4/2012 HETERO LABS LTD ATORVASTATIN CALCIUM TRIHYDRATE (FORM I)
### A II 5/28/2012 SHARON BIO MEDICINE LTD TELMISARTAN USP
### A III 5/31/2012 AMCOR FLEXIBLES BURGDORF GMBH COMPOUND PACKAGING MATERIAL
PAPER/OPA/ALUMINIUM/ION
### I II 6/4/2012 CRYSTAL PHARMA LTD SOLIFENACIN SUCCINATE
### A II 6/4/2012 TEVA PHARMACEUTICAL INDUSTRIES AZACITIDINE
LTD
### A II 6/5/2012 POSH CHEMICALS PRIVATE LTD SULFASALAZINE USP
### A II 6/5/2012 KYOWA PHARMA CHEMICAL CO LTD TRANEXAMIC ACID DRUG SUBSTANCE
### I II 6/5/2012 TRIFARMA SPA COLOCORTOLONE PIVALATE
### I II 5/30/2012 SARV BIO LABS PVT LTD THIOCOLCHICOSIDE
### A II 6/6/2012 HETERO DRUGS LTD GABAPENTIN
### A II 5/25/2012 SHANDONG XINHUA PHARMACEUTICAL AMLODIPINE BESYLATE
CO LTD
### A III 5/14/2012 BETTS INDIA PRIVATE LTD LAMINATED TUBES USED FOR PACKAGING
### A III 6/5/2012 POLYONE CORP CC10161654XX (AMBER ARCH)
### A II 6/7/2012 HETERO DRUGS LTD LACOSAMIDE
### A II 6/8/2012 SUNNY PHARMTECH INC CYCLOPHOSPHAMIDE
### A II 6/27/2012 ALEMBIC PHARMACEUTICALS LTD DARIFENACIN HYDROBROMIDE
### A II 4/5/2013 MACLEODS PHARMACEUTICALS LTD TADALAFIL
### A III 5/31/2012 ST GOBAIN PERFORMANCE PLASTICS POLYESTER FILM C/1/S WITH 4130 SILICONE
CORP RELEASE COATING, POLYESTER FILM C/1/S
WITH 4140 SILICONE RELEASE COATING
### I III 6/8/2012 COLORS FOR PLASTICS INC THERMOPLASTIC RESIN COLORANT
MASTERBATCHES B24338 BLUE 286C, E16055
GREEN 369C AND W05255 WHITE
### A II 6/8/2012 NERPHARMA SRL BENDAMUSTINE HYDROCHLORIDE
MONOHYDRATE DRUG SUBSTANCE
### A II 4/28/2012 ZHEJIANG HUAHAI PHARMACEUTICAL OLMESARTAN MEDOXOMIL USP
CO LTD
### I II 7/17/2012 UBE INDUSTRIES LTD DS-1442B DRUG SUBSTANCE
### A II 7/2/2012 CADILA HEALTHCARE LTD PHENTERMINE HYDROCHLORIDE USP
### A II 4/18/2011 SIGNA SA DE CV GEIBROZIL USP (GEA PROCESS)
### A II 6/8/2012 STANDARD CHEM AND PHARM CO LTD RILUZOLE
### A II 6/12/2012 FARMABIOS SPA FLUNISOLIDE HEMIHYDRATE (MICRONIZED)
### A III 5/25/2012 APTAR VILLINGEN GMBH AIRLESS PUMP DISPENSERS
### A II 2/8/2012 SIGNA SA DE CV ROSUVASTATIN CALCIUM
Page 824
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 6/9/2012 MSN PHARMACHEM PRIVATE LTD MILNACIPRAN HYDROCHLORIDE [ROUTE CODE
-MR"]
### A III 5/29/2012 CCC PLASTICS CANADA COLORS AND WHITE MB50-936 POLYPROPYLENE COLOUR
CHEMICALS LTD CONCENTRATE
### A II 6/1/2012 SYMBIOTICA SPECIALITY INGREDIENTS MOMETASONE FUROATE
SDN BHD
### A III 5/23/2012 MEDIPPEX SAS POLYPROPYLENE BAGS WITH CONNECTORS
### I III 5/23/2012 MEDIPPEX SAS PVC BAGS WITH CONNECTORS
### A II 6/8/2012 MSN LABORATORIES PRIVATE LTD AMBRISENTAN [ROUTE CODE - AB]
### A IV 6/13/2012 GM CHEMIE PVT LTD CELLULOSE ACETATE PHTHALATE
(CELLACEFATE) USP
### A II 5/28/2012 PARABOLIC DRUGS LTD BOSENTAN MONOHYDRATE
### A II 6/15/2012 CKD BIO CORP RIFAMYCIN O, NON-STERILE API
### I II 6/11/2012 ADARE PHARMACEUTICALS INC TENOFOVIR RAPIDLY DISINTEGRATING
TABLETS, 40 MG
### I II 6/11/2012 ADARE PHARMACEUTICALS INC EMTRICITABINE RAPIDLY DISINTEGRATING
TABLETS, 40 MG
### I II 6/11/2012 ADARE PHARMACEUTICALS INC EMTRICITABINE AND TENOFOVIR RAPIDLY
DISINTEGRATING TABLETS, 40 MG/40 MG
### A II 6/11/2012 ZHEJIANG RAYBOW PHARMACEUTICAL VENLAFAXINE HYDROCHLORIDE CRYSTALLINE
CO LTD FORM B
### A II 6/7/2012 CENTAUR PHARMACEUTICALS PVT LTD ES-ZOPICLONE USP
### I III 6/15/2012 ZHONGSHAN CITY CONTRONG MEDICAL NON-PVC MEDICAL PACKING FILM
PACKAGING MATERIAL CO LTD
### A II 6/19/2012 SYMBIOTEC PHARMALAB PRIVATE LTD TESTOSTERONE ENANTHATE, USP
### A II 7/7/2012 CADILA PHARMACEUTICALS LTD VALSARTAN USP (PROCESS 2)
### I IV 6/6/2012 JC BIOLOGY TECHNOLOGY CO LTD BRIGHT POLY UNFILLED HARD SHELL PULLULAN
CAPSULES
### A V 6/15/2012 ACS DOBFAR SPA STERILE FINISHED PRODUCTS AS STERILE
PROCESSING OPERATIONS, AND LOCATED IN
MILANO, ITALY- VIALE ADDETTA PLANT-
LYOPHILIZATION PLANT NO.1
### A II 1/23/2013 CIPLA LTD IMATINIB MESYLATE (A-FORM)
### A II 6/7/2012 CHONGQING PHARSCIN HYDROTALCITE NON STERILE, DRUG
PHARMACEUTICAL CO LTD SUBSTANCE
### A II 10/26/2012 SUN PHARMACEUTICAL INDUSTRIES FESOTERODINE FUMARATE
LTD
### A II 10/9/2012 SUN PHARMACEUTICAL INDUSTRIES LACOSAMIDE
LTD
### A V 7/16/2012 CORDEN PHARMA LATINA SPA ASEPTIC ONCOLOGICAL FACILITY
### A II 6/28/2012 UNIMARK REMEDIES LTD NITROFURANTOIN ANHYDROUS USP
(MACROCRYSTALS)
### A II 7/13/2012 ORCHID PHARMA LTD ALMOTRIPTAN MALATE
### A II 6/22/2012 HETERO DRUGS LTD RITONAVIR PREMIX AMORPHOUS
### A II 6/25/2012 DISHMAN CARBOGEN AMCIS LTD CETIRIZINE HYDROCHLORIDE
Page 825
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 6/22/2012 DELTA BIOTECH SA TRAVOPROST
### A II 6/22/2012 DELTA BIOTECH SA LATANOPROST
### A II 7/11/2012 GLOPEC INTERNATIONAL INC ACITRETIN
### I II 6/26/2012 CRYSTAL PHARMA SAU ETHINYL ESTRADIOL
### A II 6/28/2012 ASENCE PHARMA PRIVATE LTD AMPHOTERICIN B USP [ORAL GRADE]
### A II 6/28/2012 HETERO LABS LTD ESCITALOPRAM OXALATE (PROCESS II)
### A V 6/26/2012 LONZA AG PROTEIN CONJUGATION PLANT (PCP) FACILITY
### I IV 6/29/2012 FONA INTERNATIONAL INC 825.0062U N-C CHERRY BERRY FLAVOR, ART
### A II 6/29/2012 FRESENIUS KABI IPSUM SRL HETACILLIN POTASSIUM STERILE
### I II 6/14/2012 FIS FABBRICA ITALIANA SINTETICI SPA SOLIFENACIN SUCCINATE
### A II 6/29/2012 CRYSTAL PHARMA SAU CLOBETASOL PROPIONATE MICRONIZED
### I II 7/3/2012 AARTI DRUGS LTD PIOGLITAZONE HYDROCHLORIDE
### I III 6/25/2012 AMPACET CORP 11078-E WHITE PE MB
### I II 6/25/2012 WATERSTONE PHARMACEUTICALS LEVETIRACETAM
HUBEI CO LTD
### A II 7/2/2012 NEULAND LABORATORIES LTD PALIPERIDONE PALMITATE
### A IV 7/3/2012 JSR CORP STYRENE ISOPRENE BLOCK COPOLYMER
### I IV 8/16/2012 LIFECELL INTERNATIONAL PRIVATE LTD DMSO 55%W/V DEXTRAN-40 5%W/V SOLUTION
### A II 7/10/2012 CTX LIFE SCIENCES PVT LTD OLMESARTAN MEDOXOMIL
### A V 6/28/2012 PIRAMAL HEALTHCARE UK LTD GRANGEMOUTH SITE (SUITE 5)
### A II 7/3/2012 UNION QUIMICO FARMACEUTICA SA LINEZOLID
(UQUIFA SA)
### A III 6/8/2012 AMI POLYMER PVT LTD IMAPURE® PLATINUM CURED SILICONE TUBING
AND REINFORCED HOSES
### I II 7/5/2012 SICHUAN XIELI PHARMACEUTICAL CO ANASTROZOLE
LTD
### A III 3/26/2012 BPREX HEALTHCARE OFFRANVILLE SAS EYE DROPPERS SETS (10ML LDPE BOTTLE+
LDPE NOZZLE + PP CAPS)
### A II 7/9/2012 HETERO DRUGS LTD DORZOLAMIDE HYDROCHLORIDE (PROCESS II)
### A II 6/29/2012 PCI SYNTHESIS PCI-114234
### I II 7/10/2012 HETERO DRUGS LTD SEVELAMER CARBONATE
### A II 7/10/2012 HETERO LABS LTD PAZOPANIB HYDROCHLORIDE
### I II 6/29/2012 JARI PHARMACEUTICAL CO LTD TORSEMIDE
### A II 10/23/2012 GLENMARK PHARMACEUTICALS LTD RUFINAMIDE
### I II 9/27/2012 CADILA PHARMACEUTICALS LTD RUPATADINE FUMARATE
26211 A IV 7/5/2012 TAKASAGO INTERNATIONAL CORP CHERRY MICRON OT-22685
### A IV 7/5/2012 TAKASAGO INTERNATIONAL CORP CHERRY FLAVOR OT-83853
### A II 8/5/2012 AVA INC CHLORHEXIDINE GLUCONATE 20% SOLUTION,
USP
### A II 11/9/2012 LUPIN LTD ATORVASTATIN CALCIUM AMORPHOUS USP
### A II 2/6/2013 LUPIN LTD ATORVASTATIN CALCIUM TRIHYDRATE USP
### A III 9/18/2012 EMPHASYS IMPORTADORA CDM-HALER®
EXPORTADORA E DISTRIBUIDORA LTDA
Page 828
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 8/1/2012 RENOLIT HANSEN PACKAGING TECH TWIST OFF PORT
(BJ) LTD
### A II 10/31/2012 LUPIN LTD FESOTERODINE FUMARATE
### A II 7/30/2012 DEAD SEA BROMINE CO LTD MAGNESIUM OXIDE
### A III 7/17/2012 OG CORP EMBOSSED PET FILM
### A IV 7/27/2012 DINESH REMEDIES LTD HARD GELATIN CAPSULE SHELLS
### A IV 7/31/2012 DDP SPECIALTY ELECTRONIC SILASTIC™ BIOMEDICAL GRADE ETR
MATERIALS US 9 LLC ELASTOMERS
### A II 8/2/2012 SHANGHAI AJINOMOTO AMINO ACID CO L-LYSINE MONOHYDROCHLORIDE
LTD
### A II 5/24/2012 MAC CHEM PRODUCTS INDIA PVT LTD CYTARABINE USP
### A II 8/14/2012 RELIANCE LIFE SCIENCES PVT LTD BORTEZOMIB
### I III 8/1/2012 BULK PACKAGING LINERS PVT LTD PE FILM 40 FEET CONTAINER LINER
### I III 8/1/2012 BULK PACKING LINERS PVT LTD PE FILM 20 FEET CONTAINER LINER
### A III 7/18/2012 NOLATO JAYCARE LTD OVERCAP
### A III 7/17/2012 NOLATO JAYCARE LTD 20ML MK2 POLYETHYLENE WHITE ROUND
BOTTLE
### I II 6/28/2012 JIANSHI YUANTONG BIOENGINEERING RUTIN
CO LTD
### I II 6/28/2012 HUNAN YUANTONG PHARMACEUTICAL TROXERUTIN
CO LTD
### A II 9/7/2012 MSN ORGANICS PRIVATE LTD FEBUXOSTAT [ROUTE CODE FUG]
### A II 7/26/2012 FARMABIOS SPA EXEMESTANE MICRONIZED USP
### A III 8/9/2012 AMCOR FLEXIBLES GENT AF GENT EXTRUDED FILMS AND LAMINATES
FOR PACKAGING
### A II 3/8/2013 APICORE US LLC MIGLUSTAT
### A II 8/9/2012 HEC PHARM CO LTD LEVOFLOXACIN NON-STERILE BULK DRUG
SUBSTANCE
### A III 8/9/2012 CONSOLIDATED BOTTLE CORP 120ML WHITE LDPE FLAT OVAL BOTTLE 20/410
### A II 8/2/2012 FIS FABBRICA ITALIANA SINTETICI SPA OLOPATADINE HYDROCHLORIDE
### A V 8/9/2012 VALDEPHARM STERILIZATION PROCESS VALIDATION FOR USE
IN CEDEX, FRANCE
### A II 8/22/2012 CIPLA LTD ABACAVIR SULFATE USP
### A IV 7/24/2012 SEPPIC SA MONTANOX 80 PPI AND MONTANOX 20 PPI
### A II 8/8/2012 TOMITA PHARMACEUTICAL CO LTD MAGNESIUM SULFATE HEPTAHYDRATE
### I II 8/8/2012 SICHUAN XIELI PHARMACEUTICAL CO URSODEOXYCHOLIC ACID
LTD
### A II 8/13/2012 HETERO DRUGS LTD LOPINAVIR AMORPHOUS
### A II 7/30/2012 ZHEJIANG APELOA JIAYUAN LAROPIPRANT
PHARMACEUTICAL CO LTD
### A II 8/3/2012 SHANGHAI DESANO CHEMICAL RILPIVIRINE HYDROCHLORIDE
PHARMACEUTICAL CO LTD
### A III 8/8/2012 COLORTECH INC 11525-16 WHITE POLYETHYLENE CONCENTRATE
Page 833
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 9/12/2012 ANKIT PULPS AND BOARDS PVT LTD MICROCRYSTALLINE CELLULOSE (USP) OF
VARIOUS GRADES
### I II 9/17/2012 ZHEJIANG XIANJU XIANMING PROGESTERONE, USP
PHARMACEUTICAL CO LTD
### I III 9/17/2012 ROSELABS BIOSCIENCE LTD ROSE-FILL-LT-5.0 ML (STERILE DISPOSABLE
PRE-FILLABLE GLASS SYRINGES 5.0 ML)
### I III 9/17/2012 ROSELABS BIOSCIENCE LTD ROSE-FILL-LT-1.0 ML (STERILE DISPOSABLE
PRE-FILLABLE GLASS SYRINGES 1.0 ML)
### I II 9/12/2012 SICHUAN XIELI PHARMACEUTICAL CO TRIMETAZIDINE DIHYDROCHLORIDE
LTD
### A II 9/18/2012 CATALENT PHARMA SOLUTIONS LLC PALONOSETRON HC1 0.50 MG SOFTGELS (1.5
OVAL)
### I II 11/6/2012 UNIMARK REMEDIES LTD MONTELUKAST SODIUM USP (PROCESS-C)
### A II 10/31/2012 GLAND CHEMICALS PRIVATE LTD BORTEZOMIB
### A II 10/25/2012 GLAND CHEMICALS PRIVATE LTD ROCURONIUM BROMIDE USP
### A II 1/11/2013 CIPLA LTD RITONAVIR USP
### A II 11/1/2012 DR REDDYS LABORATORIES LTD PLERIXAFOR
### A II 9/30/2013 SUN PHARMACEUTICAL INDUSTRIES BUDESONIDE USP
LTD
### A II 9/26/2012 BIOPHORE INDIA PHARMACEUTICALS ZILEUTON
PVT LTD
### A II 9/26/2012 BIOPHORE INDIA PHARMACEUTICALS PHYTONADIONE
PVT LTD
### A II 9/17/2012 MACFARLAN SMITH LTD A JOHNSON BUPRENORPHINE
MATTHEY CO
### I II 9/7/2012 XIWANG PHARMACEUTICAL CO LTD DEXTROSE MONOHYDRATE
### I II 9/7/2012 XIWANG PHARMACEUTICAL CO LTD DEXTROSE ANHYDROUS
### A II 8/9/2012 HUNAN LIJIE BIOCHEMICAL CO LTD CHLOROXYLENOL
### A II 9/27/2012 AUROBINDO PHARMA LTD GATIFLOXACIN HEMIHYDRATE (NON-STERILE
DRUG SUBSTANCE)
### A II 9/20/2012 HYBIO PHARMACEUTICAL CO LTD EPTIFIBATIDE ACETATE, NON-STERILE BULK
DRUG SUBSTANCE
### A II 8/30/2012 BEIJING GEYUAN TIANRUN BIO TECH CHYMOTRYPSIN (NON-STERILE, BULK FORM)
CO LTD
### A II 9/21/2012 ARGUS PHARMACEUTICALS LTD ORLISTAT
### A II 9/18/2012 SICHUAN XIELI PHARMACEUTICAL CO GEFITINIB
LTD
### A II 9/12/2012 WUXI KAILI PHARMACEUTICAL CO LTD EPTIFIBATIDE
### A II 9/18/2012 TIANJIN TIANYAO PHARMACEUTICALS METHYLPREDNISOLONE, USP
CO LTD
### A II 9/21/2012 SANDOZ PRIVATE LTD SILODOSIN
### I II 9/18/2012 SICHUAN XIELI PHARMACEUTICAL CO SORAFENIB TOSYLATE
LTD
### I II 9/20/2012 SICHUAN XIELI PHARMACEUTICAL CO VIDAGLIPTIN
LTD
Page 834
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 9/18/2012 SICHUAN XIELI PHARMACEUTICAL CO CABAZITAXEL
LTD
### A II 10/6/2012 EMCURE PHARMACEUTICALS LTD RITONAVIR USP (PROCESS II)
### I II 9/18/2012 SICHUAN XIELI PHARMACEUTICAL CO SUNITINIB MALATE
LTD
### I II 9/20/2012 SICHUAN XIELI PHARMACEUTICAL CO LAPATINIB TOSYLATE
LTD
### I II 9/21/2012 TOMITA PHARMACEUTICAL CO LTD USP SODIUM SULFATE, ANHYDROUS
### I II 9/21/2012 GLOCHEM INDUSTRIES LTD CETIRIZINE DIHYDROCHLORIDE
### A II 9/20/2012 ERREGIERRE SPA DEFERASIROX
### A II 11/16/2012 NECTAR LIFESCIENCES LTD CEFTAZIDIME FOR INJECTION USP (STERILE
BULK)
### I II 9/17/2012 RESONANCE LABORATORIES PVT LTD GLYCOPYRROLATE
### A III 9/21/2012 EQUISTAR CHEMICALS LP A PRO-FAX SR257M POLYPROPYLENE
LYONDELLBASELL INDUSTRIES CO COPOLYMER RESIN
### A II 10/6/2012 CADILA HEALTHCARE LTD LACOSAMIDE
### A II 9/21/2012 INCELL CORP LLC ZAPR RED BLOOD CELL LYSING BUFFER
### A II 9/11/2012 JIAXING HENGJIE BIOPHARMACEUTICAL CHONDROITIN SULFATE SODIUM (NON STERILE,
CO LTD BULK FORM)
### A II 10/3/2012 DR REDDYS LABORATORIES LTD DUTASTERIDE (PROCESS-II)
### A II 9/21/2012 ZHEJIANG MEDICINE CO LTD XINCHANG BOSENTAN MONOHYDRATE
PHARMACEUTICAL FACTORY
### A II 5/2/2013 CHEMWERTH INC DRONEDARONE HYDROCHLORIDE NON-
STERILE BULK DRUG
### A II 10/12/2012 MSN ORGANICS PRIVATE LTD (2R,3R)-3(3-METHOXY PHENYL)-N,N,2-
TRIMETHYL PENTANE-1-AMINE
HYDROCHLORIDE [ROUTE CODE TPT4]
### A II 9/26/2012 INTERQUIM SA ROTIGOTINE
### I II 9/24/2012 SICHUAN XIELI PHARMACEUTICAL CO DIOSMIN
LTD
### A II 10/12/2012 AMOLI ORGANICS PVT LTD CLOTRIMAZOLE USP
### A II 9/27/2012 SIGNA SA DE CV LACOSAMIDE
### I II 9/24/2012 SICHUAN XIELI PHARMACEUTICAL CO TROXERUTIN
LTD
### I II 9/21/2012 SICHUAN XIELI PHARMACEUTICAL CO SOY ISOFLAVONES
LTD
### A II 9/27/2012 AMBIOPHARM INC GLATIRAMER NON-STERILE, BULK DRUG
SUBSTANCE
### A II 9/27/2012 EUTICALS INC TAPENTADOL HYDROCHLORIDE DRUG
SUBSTANCE
### A II 9/27/2012 LEK PHARMACEUTICALS DD FESOTERODINE FUMARATE
### I II 9/27/2012 SICHUAN XIELI PHARMACEUTICAL CO RALOXIFENE HYDROCHLORIDE
LTD
### I II 9/28/2012 SICHUAN XIELI PHARMACEUTICAL CO TELBIVUDINE
LTD
Page 835
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 9/25/2012 SICHUAN XIELI PHARMACEUTICAL CO DASATINIB
LTD
### I II 9/26/2012 SICHUAN XIELI PHARMACEUTICAL CO SITAGLIPTIN PHOSPHATE
LTD
### A III 9/25/2012 COIM USA INC NOVACOTE HS-8256
### I II 9/28/2012 SICHUAN XIELI PHARMACEUTICAL CO NILOTINIB
LTD
### A II 9/28/2012 CHEMI SPA FESOTERODINE FUMARATE
### A II 9/26/2012 MYLAN LABORATORIES LTD RIVASTIGMINE USP (PROCESS II)
### A II 9/27/2012 SOLARA A PHARMA SCIENCES LTD LEVETIRACETAM
### A II 9/27/2012 HETERO LABS LTD ENTACAPONE
### A II 9/26/2012 SYN-TECH CHEM AND PHARM CO LTD NAFTOPIDIL
### A II 10/13/2012 INTAS PHARMACEUTICALS LTD FESOTERODINE FUMARATE
### A II 9/26/2012 SYN-TECH CHEM AND PHARM CO LTD GRANISETRON HYDROCHLORIDE USP
### A II 10/30/2012 DSM SINOCHEM PHARMACEUTICALS AMPICILLIN TRIHYDRATE (PURICILLIN)
NETHERLANDS BV
### A IV 10/1/2012 SHANXI GUANGSHENG MEDICINAL VACANT CAPSULE
CAPSULE CO LTD
### A II 10/24/2012 WOCKHARDT BIO AG FESOTERODINE FUMARATE
### I II 9/28/2012 SICHUAN XIELI PHARMACEUTICAL CO HESPERIDIN
LTD
### I II 9/28/2012 SICHUAN XIELI PHARMACEUTICAL CO RUTOSIDE TRIHYDRATE
LTD
### I III 9/28/2012 ROSELABS POLYMERS LTD ROSEPOLY FILL LT 5 ML (STERILE HYPODERMIC
DISPOSABLE PREFILLABLE SYRINGE 5 ML)
26511 I III 9/28/2012 ROSELABS POLYMERS LTD ROSEPOLY FILL LT 2.25 ML (STERILE
HYPODERMIC DISPOSABLE PREFILLABLE
SYRINGE 2.25 ML)
### I III 9/28/2012 ROSELABS POLYMERS LTD ROSEPOLY FILL LT 1 ML (STERILE HYPODERMIC
DISPOSABLE PREFILLABLE SYRINGE 1 ML)
Page 837
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 10/16/2012 NEOPHARM CO LTD METHYL CAPROOYL TYROSINATE (CODE NAME:
DEFENSAMIDE)
### I II 10/10/2012 AMPACET CORP 140891 ORANGE PP MB
### A III 9/20/2012 INVISTA RESINS AND FIBERS GMBH POLYETHYLENE TEREPHTHALATE RESINS USED
IN PACKAGING
### I II 10/15/2012 HUATAI BIOPHARM INC OMEGA-3-ACID ETHYL ESTERS (NON-STERILE,
BULK FORM)
### A III 10/12/2012 BASF SE ULTRAFORM W2320 003 PRO TR UNCOLORED
### I II 9/28/2012 LIANYUNGANG RUNZHONG PALONOSETRON HYDROCHLORIDE
PHARMACEUTICAL CO LTD
### I II 10/24/2012 MELODY HEALTHCARE PVT LTD ALBUTEROL SULFATE
### I II 9/14/2012 MELODY HEALTHCARE PVT LTD TERBUTALINE SULPHATE
### I III 10/10/2012 AMPACET CORP 181356 DARK BROWN PP MB
### I III 10/10/2012 AMPACET CORP 454458 PEARL RED PP MB
### I III 10/9/2012 AMPACET CORP 164364-K BLUE 364
### I III 10/10/2012 AMPACET CORP 131617 YELLOW PP MB
### I III 10/10/2012 AMPACET CORP 401198 HIGH HEAT PA PP MB
### A III 10/10/2012 ROCHLING MEDICAL NEUHAUS GMBH WHITE PE-BOTTLE 60ML
AND CO KG
### A II 10/16/2012 KINOMEGA BIOPHARM INC OMEGA-3-ACID ETHYL ESTERS
### A II 11/29/2012 TEVA PHARMACEUTICAL INDUSTRIES ATORVASTATIN CALCIUM
LTD
### A II 10/25/2012 IRVINE SCIENTIFIC SALES CO BALANCD CHO GROWTH A ( PRODUCT NUMBER
91128)
### A III 12/28/2012 KURARAY CO LTD HYBRAR ™ AND SEPTON ™ HYDROGENATED
STYRENE-ISOPRENE, BUTADIENE OR
ISOPRENE/BUTADIENE BLOCK COPOLYMERS
### A II 10/25/2012 IRVINE SCIENTIFIC SALES CO BALANCD CHO FEED 2 (PRODUCT NUMBER
91129)
### A II 10/25/2012 IRVINE SCIENTIFIC SALES CO BALANCD™ CHO FEED 1 (PRODUCT NUMBER
91127)
### A II 10/22/2012 FUKUZYU PHARMACEUTICAL CO LTD NPS-005
### A II 12/3/2012 CENTAUR PHARMACEUTICALS PVT LTD MILNACIPRAN HYDROCHLORIDE
### I II 1/11/2013 RPG LIFE SCIENCES LTD MYCOPHENOLATE MOFETIL USP
### I II 10/24/2012 MELODY HEALTHCARE PVT LTD LEVOSALBUTAMOL SULPHATE
### A II 10/26/2012 MAC CHEM PRODUCTS INDIA PVT LTD DOCETAXEL TRIHYDRATE USP
### A II 10/26/2012 MAC CHEM PRODUCTS INDIA PVT LTD ANASTROZOLE USP
### A II 2/11/2013 LUPIN LTD FEBUXOSTAT (MICRONIZED)
### I IV 10/26/2012 FONA INTERNATIONAL INC 863.002 N-C LEMON-LIME FLAVOR, NAT WONF
### I IV 10/26/2012 FONA INTERNATIONAL INC 884.628 N-C ORANGE FLAVOR, NATURAL
### A II 10/29/2012 IRVINE SCIENTIFIC SALES CO BALANCD CHO FEED 3 (PRODUCT NUMBER
99471)
### I II 10/23/2012 IOL CHEMICALS AND LANSOPRAZOLE
PHARMACEUTICALS LTD
Page 838
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 10/26/2012 WEST PHARMACEUTICAL SERVICES INC NOVAGUARD SA SAFE SYSTEM
### A III 10/16/2012 UFLEX LTD PET + ALUMINIUM FOIL + POLY LAMINATES
### A II 12/30/2013 WISDOM PHARMACEUTICAL CO LTD MEFENAMIC ACID
### A III 10/16/2012 UFLEX LTD PAPER + POLY + ALUMINIUM FOIL + POLY
LAMINATE
### A III 10/16/2012 UFLEX LTD POLYAMIDE (NYLON) + ALUMINUM FOIL + PVC
LAMINATE
### A V 10/22/2012 NORTHSTAR MEDICAL RADIOISOTOPES RADIOGENIX ™SYSTEM
LLC
### A II 12/23/2012 WISDOM PHARMACEUTICAL CO LTD DRONEDARONE HYDROCHLORIDE
### A II 12/17/2012 SYMPHONY PHARMA LIFESCIENCES LACOSAMIDE
PRIVATE LTD
### A II 10/30/2012 LAURUS LABS LTD DOCETAXEL ANHYDROUS, USP (PROCESS-2)
### A II 11/5/2012 AMOLI ORGANICS PVT LTD ASCORBIC ACID USP
### A II 11/2/2012 ZHEJIANG CHARIOTEER VALGANCICLOVIR HYDROCHLORIDE,
PHARMACEUTICAL CO LTD AMORPHOUS (DRUG SUBSTANCE)
### A III 10/26/2012 NEW AGE INDUSTRIES INC ADVANTAPURE SILICONE APST TUBING NI201
### A II 12/21/2012 GLENMARK PHARMACEUTICALS LTD RASAGILINE MESYLATE
### A II 11/7/2012 SIGMUND LINDNER GMBH SILIBEADS-CERAMIC BEADS ZY
### A V 10/22/2012 EVONIK NUTRITION AND CARE GMBH EUDRAGIT® L/S
### A II 11/12/2012 HETERO LABS LTD PLERIXAFOR
### A II 12/21/2012 HISUN PHARMACEUTICAL HANGZHOU DAPTOMYCIN
CO LTD
### A II 12/27/2012 ZHEJIANG HISUN PHARMACEUTICAL CO DONEPEZIL HYDROCHLORIDE USP
LTD
### A II 12/30/2012 ZHEJIANG HISUN PHARMACEUTICAL CO IMATINIB MESYLATE
LTD
### I II 2/8/2013 SUN PHARMACEUTICAL INDUSTRIES FEBUXOSTAT
LTD
### A III 11/12/2012 AMERICAN PACKAGING CORP PILL PACK OVERWRAP POUCH - PRINTED
LAMINATION
### A III 11/9/2012 COMPAGNIE SELENIS CANADA POLY(ETHYLENE TEREPHTHALATE)
### A II 11/2/2012 NANYANG PUKANG PHARMACEUTICAL LINCOMYCIN HYDROCHLORIDE
CO LTD
26611 A II 11/7/2012 DERIVADOS QUIMICOS SAU MILNACIPRAN HYDROCHLORIDE
### A IV 11/8/2012 FINAR LTD ACETONITRILE HIGH PURITY GRADE (HP)
### A III 11/9/2012 SANNER GMBH CONTAINER PACKAGING MATERIAL
### A II 12/13/2012 SUN PHARMACEUTICAL INDUSTRIES PEMETREXED DISODIUM USP
LTD
### A II 12/20/2012 SUN PHARMACEUTICAL INDUSTRIES DESVENLAFAXINE FUMARATE MONOHYDRATE
LTD
### I III 11/7/2012 AMPACET CORP 433548 TRANSP YELLOW SMC PP MB
### A III 10/30/2012 AMPACET CORP 466276 MYLAN BLUE SLIP PP MB
### A II 11/12/2012 MEIJI SEIKA PHARMA CO LTD ME1111 DRUG SUBSTANCE
Page 839
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 10/29/2012 NTP RADIOISOTOPES SOC LTD FISSION IODINE-131 (PRODUCED FROM LOW
ENRICHED URANIUM(LEU) NORMAL PRODUCT
### A II 1/9/2013 LUPIN LTD MILNACIPRAN HYDROCHLORIDE
### A III 11/16/2012 ASAHI KASEI CORP TUFTEC STYRENE BLOCK POLYMER WITH 1,3-
BUTADIENE, HYDROGENATED
### A II 11/19/2012 BIAL PORTELA AND CA SA ESLICARBAZEPINE ACETATE
### I II 12/31/2012 CATALENT PHARMA SOLUTIONS LLC SOFT GELATIN CAPSULE - OET-10275258
### A II 11/19/2012 RAKS PHARMA PVT LTD MILNACIPRAN HYDROCHLORIDE, API
### A IV 11/12/2012 UNGERER AND CO ARTIFICIAL BUBBLEGUM FLAVOR FS-12019
### A III 11/8/2012 PRETIUM PACKAGING LLC PLASTIC PACKAGING MATERICALS
### A II 11/15/2012 IOL CHEMICALS AND LAMOTRIGINE
PHARMACEUTICALS LTD
### I III 11/12/2012 LOTTE CHEMICAL DAESAN PLANT POLYPROPYLENE (PP) - SB-520Y
### I III 11/15/2012 LOTTE CHEMICAL YEOSU PLANT POLYPROPYLENE (PP) - SB-520Y, SB-550Y, SB-
740D, SFC-750D, SFO-130A
### A II 12/7/2012 APOTEX PHARMACHEM INC ADEFOVIR DIPIVOXIL
### A II 1/22/2013 APOTEX PHARMACHEM INC ERLOTINIB HYDROCHLORIDE
### A II 3/5/2013 CADILA PHARMACEUTICALS LTD BOSENTAN MONOHYDRATE
### A III 4/9/2013 SHANGHAI BLOPAK CO LTD COLLAPSIBLE PLASTIC TUBES FOR
PHARMACEUTICAL PACKAGING
### A IV 11/16/2012 BEIJING YINGMAO PHARMACEUTICAL GASTRIC FILM COATING SYSTEM
CO LTD
### A II 9/27/2012 OLON SPA CLOFARABINE
### A III 8/14/2012 HUHTAMAKI PPL LTD FLEXIBLE LAMINATES AND SPECIALIZED
POUCHES, IN 1 PLY, 2PLY, 3PLY, 4PLY, 5PLY, AND
6PLY SHRINK SLEEVES AND LABELS FOR
PACKING ALL PHARMACEUTICAL APPLICATION
### A II 12/10/2012 SIGNA SA DE CV EZETIMIBE USP
### A V 11/20/2012 FUJIFILM DIOSYNTH BIOTECHNOLOGIES ABC5000 CONTRACT MANUFACTURING
UK LTD FACILITIES FOR THE MANUFACTURE OF
BIOTECHNOLOGY DRUG SUBSTANCES
### A II 12/21/2012 SIGNA SA DE CV PROGESTERONE USP
### A II 1/24/2013 INTERPHARMA PRAHA AS IOHEXOL DRUG SUBSTANCE, FOR ORAL
PRODUCTS
### A II 11/26/2012 SOLARA A PHARMA SCIENCES LTD MILNACIPRAN HYDROCHLORIDE
### A II 11/26/2012 SANOCHEMIA PHARMAZEUTIKA AG GALANTAMINE HYDROBROMIDE
### A III 11/22/2012 JAPAN VILENE CO LTD MEDICAL RELEASE LINER FILM, DL-01
### I III 11/20/2012 AMPACET CORP 113375-K BLOMITE 75
### A III 11/26/2012 STELLA KUNSTSTOFFTECHNIK GMBH PLASTIC BOTTLE PP28, 50 ML, ACP 6031 D AN
SECRO PP28 CHILDPROOF CLOSURE
### A II 11/8/2012 SEVEN STAR PHARMACEUTICAL CO LTD GADOPENTETATE DIMEGLUMINE
Page 844
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/24/2012 CHONGQING PHARMACEUTICAL ABIRATERONE ACETATE (NON-STERILE BULK
RESEARCH INSTITUTE CO LTD DRUG SUBSTANCE)
### A IV 1/2/2013 HUBEI GREENHOME MATERIALS BENZYL ALCOHOL
TECHNOLOGY INC
### A II 4/9/2013 LUPIN LTD ROSUVASTATIN CALCIUM
### A II 4/18/2013 LUPIN LTD OLMESARTAN MEDOXOMIL USP
### A II 3/11/2013 GLENMARK PHARMACEUTICALS LTD SITAGLIPTIN PHOSPHATE MONOHYDRATE
### A II 2/5/2013 MSN LABORATORIES PRIVATE LTD PALONOSETRON HYDROCHLORIDE USP
[ROUTE CODE PI]
### A II 3/8/2013 MSN ORGANICS PRIVATE LTD ASENAPINE MALEATE [ROUTE CODE AN]
### A II 2/8/2013 MSN ORGANICS PRIVATE LTD TADALAFIL USP [ROUTE CODE - "TP"]
### I II 1/3/2013 PHARMACEUTICAL WORKS POLPHARMA ACYCLOVIR
SA
### I III 1/1/2013 MULTIPLAST POLYMER PVT LTD PLASTIC HDPE BOTTLES FOR
PHARMACEUTICAL USE
### A II 1/4/2013 NOSCH LABS PRIVATE LTD DULOXETINE HYDROCHLORIDE, USP
### A III 1/4/2013 HSIAO SUNG NON OXYGEN CHEMICAL DESICCANT
CO LTD
### A II 12/30/2012 CHONGQING CARELIFE CLINDAMYCIN PALMITATE HC1 USP(NON-
PHARMACEUTICAL CO LTD STERILE BULK DRUG SUBSTANCE)
### A II 1/17/2013 INTAS PHARMACEUTICALS LTD PACLITAXEL USP (SEMI-SYNTHETIC)
### I II 1/15/2013 CATALENT PHARMA SOLUTIONS LLC SOFTGEL CAPSULE [OET-10275263]
### A II 12/27/2012 SUVEN LIFE SCIENCES LTD DOXOFYLLINE
### A II 2/6/2013 SUN PHARMACEUTICAL INDUSTRIES EPTIFIBATIDE
LTD
### A II 3/14/2013 SUN PHARMACEUTICAL INDUSTRIES OMEPRAZOLE USP
LTD
### A II 1/7/2013 STERLING SPA DESOXYCORTICOSTERONE PIVALATE
### I IV 1/8/2013 SEPPIC SA SEPICOAT
### A II 1/7/2013 LEE PHARMA LTD LANSOPRAZOLE USP
### A II 12/13/2012 CAMBREX CHARLES CITY INC SUFENTANIL CITRATE
### I II 1/4/2013 ZHEJIANG ZONE BANNER CHEMICAL CO 3-CHLORO-IMINODIBENZYL
LTD
### I II 1/5/2013 HEC PHARM CO LTD IRBESARTAN NON-STERILE BULK DRUG
SUBSTANCE
### A II 1/9/2013 HUBEI GEDIAN HUMANWELL DUTASTERIDE
PHARMACEUTICAL CO LTD
### A II 1/31/2013 ZHEJIANG HUAHAI PHARMACEUTICAL METOPROLOL SUCCINATE USP
CO LTD
### A II 12/18/2012 FRESENIUS KABI IPSUM SRL CLOXACILLIN BENZATHINE STERILE
### A II 8/6/2012 FARMHISPANIA SA METFORMIN HYDROCHLORIDE / 0.75%
COLLOIDAL SILICON DIOXIDE BLEND
### A II 2/20/2013 GLENMARK PHARMACEUTICALS LTD FINGOLIMOD HYDROCHLORIDE
### A II 2/18/2013 CENTAUR PHARMACEUTICALS PRIVATE TRANYLCYPROMINE SULFATE USP
LTD
Page 845
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 1/16/2013 JC BIOLOGY TECHNOLOGY CO LTD UNFILLED HARD SHELL HYPROMELLOSE
CAPSULES
### A III 1/10/2013 SAGAR RUBBER PRODUCTS PVT LTD RUBBER GASKET FOR PRE-FILLED SYRINGES
(RFS/RFU)
26811 I II 1/15/2013 HEC PHARM USA INC FELODIPINE NON-STERILE BULK DRUG
SUBSTANCE
### A III 1/3/2013 CHARTER NEX FILMS INC CHARTER NEX FILMS GRADE C8082
### I II 2/5/2013 IND SWIFT LABORATORIES LTD COLESEVELAM HYDROCHLORIDE
### A II 2/15/2013 EMCURE PHARMACEUTICALS LTD DARIFENACIN HYDROBROMIDE
### A II 2/1/2013 EMCURE PHARMACEUTICALS LTD FEBUXOSTAT
### A II 9/5/2013 ACIC FINE CHEMICALS INC CYSTEAMINE BITARTRATE
### A III 1/18/2013 AVERY DENNISON CORP S-2060N ADHESIVE
### A II 1/6/2013 LIANYUNGANG GUIKE CAPECITABINE (NON-STERILE, BULK FORM)
PHARMACEUTICAL CO LTD
### A II 2/8/2013 CHUNGHWA CHEMICAL SYNTHESIS AND EVEROLIMUS PRE-MIX
BIOTECH CO LTD
### I II 1/31/2013 ZHEJIANG HISUN PHARMACEUTICAL CO MEROPENEM STERILE
LTD
### A III 1/17/2013 SHREE RAMA MULTI TECH LTD LAMI TUBES
### A II 1/18/2013 YMC CO LTD YMC-TRIART
### A III 1/18/2013 BORMIOLI PHARMA SPA PET BOTTLE
### A II 8/23/2013 APOTEX PHARMACHEM INC DARIFENACIN HYDROBROMIDE
### A II 3/30/2013 SUN PHARMACEUTICAL INDUSTRIES TEMSIROLIMUS
LTD
### A II 3/19/2013 SUN PHARMACEUTICAL INDUSTRIES PALIPERIDONE USP
LTD
### A III 12/20/2012 LOPAREX LLC FLUORINE SILICONE 5199 COATED RELEASE
LINERS
### A II 2/13/2013 APOTEX PHARMACHEM INDIA PVT LTD ESZOPICLONE USP
### A II 1/31/2013 FORTEQ NIDAU AG MIRENA® INSERTER PROJECT
### A III 1/18/2013 EQUISTAR CHEMICALS LP A PRO-FAX RP512H POLYPROPYLENE
LYONDELLBASELL INDUSTRIES CO COPOLYMER RESIN
### A II 2/20/2013 POLYPEPTIDE LABORATORIES SWEDEN LEUPROLIDE ACETATE
AB
### A II 2/27/2013 ALEMBIC PHARMACEUTICALS LTD DEFERASIROX
### I III 1/15/2013 JOBAN GLASS CO LTD TUBULAR VIALS FOR PHARMACEUTICAL USE
### A II 3/15/2013 TEVA PHARMACEUTICAL INDUSTRIES FULVESTRANT
LTD
### I III 1/21/2013 COLORS FOR PLASTICS INC THERMOPLASTICS RESIN R34151 RED/1797C
COLORANT MASTERBATCH
### A II 1/14/2013 SHANGHAI DESANO CHEMICAL PRAZIQUANTEL
PHARMACEUTICAL CO LTD
### A IV 1/17/2013 TAKASAGO INTERNATIONAL CORP MICRON INTENSATES NATURAL AND ARTIFICIAL
COOL SPEARMINT FLAVOR TAK-122461
Page 846
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 1/17/2013 TAKASAGO INTERNATIONAL CORP TAK-122311 MICRON INTENSATES ARTIFICAL ICE
FLAVOR
### A II 3/29/2013 TARO PHARMACEUTICAL INDUSTRIES DESOXIMETASONE USP, MICRONIZED
LTD
### A IV 1/17/2013 TAKASAGO INTERNATIONAL CORP TAK-122134 MICRON INTENSATES NATURAL AND
ATIFICIAL PEPPERMINT EXTRA FLAVOR
### I II 1/22/2013 HEC PHARM USA INC SIMVASTATIN NON-STERILE DRUG SUBSTANCE,
BULK FORM
### A II 1/18/2013 SHANDONG XINHUA PHARMACEUTICAL ASPIRIN REFINED
CO LTD
### A II 12/15/2012 ZHEJIANG CHENG YI PHARMACEUTICAL RIBAVIRIN
CO LTD
### A II 2/7/2013 LAURUS LABS LTD AZACITIDINE
### A II 12/15/2012 ZHEJIANG CHENG YI PHARMACEUTICAL AZATHIOPRINE
CO LTD
### A II 2/13/2013 ZHEJIANG HUAHAI PHARMACEUTICAL FEBUXOSTAT
CO LTD
### A II 12/30/2012 ZHEJIANG CHENG YI PHARMACEUTICAL MERCAPTOPURINE
CO LTD
### A II 1/25/2013 ZHEJIANG RAYBOW PHARMACEUTICAL MAP(VERSION NO.:1) (4R,5R,6S)-3-
CO LTD [(DIPHENOXYPHOSPHINYL)OXYL-6-[(1R)-1-
HYDROXYETHYL]-7-OXO-1-
AZABICYCLO[3.2.0]HEPT-2-ENE-2-CARBOXYLIC
ACID (4-NITROPHENYL) METHYL ESTER
### I III 1/30/2013 MITSUBISHI GAS CHEMICAL CO INC T-ESTER
### A II 3/15/2013 JUBILANT GENERICS LTD APREPITANT
### A III 1/25/2013 BPREX HEALTHCARE OFFRANVILLE SAS EYE DROPPERS SETS (PP SOFT BOTTLES + PP
SOFT NOZZLE + HDPE CAPS)
### A IV 2/4/2013 FIRMENICH INC FRAGRANCE FORMULAS
### A II 1/30/2013 STERLING SPA FULVESTRANT
### A II 10/18/2013 CHONGQING SHENGHUAXI AZTREONAM
PHARMACEUTICAL CO LTD
### A II 1/28/2013 GANGWAL CHEMICALS PVT LTD ISOXSUPRINE HYDROCHLORIDE
### A III 1/4/2013 ASTRA PLASTIQUE CLOSURE PHARMASAFE MADE OUT OF
THERMOPLASTIC MATERIALS
### A IV 1/23/2013 HENKEL CORP DURO-TAK 87-4900 PRESSURE SENSITIVE
ADHESIVE
### A V 1/29/2013 LUBRIZOL ADVANCED MATERIALS INC TOXICOLOGY AND REGULATORY REVIEW-
CARBOMER CLASS OF POLYMERS
### A II 2/4/2013 GEDEON RICHTER PLC ULIPRISTAL ACETATE MICRONIZED
### A II 1/22/2013 CHIRAL QUEST SUZHOU CO LTD (S)-3-METHYLAMINO-1-(THIOPHENE-2-
YL)PROPAN-1-OL
### A II 2/4/2013 GANGWAL CHEMICALS PVT LTD SALMETEROL XINAFOATE IP/BP
### A II 3/22/2013 JANSSEN PHARMACEUTICA NV SIMEPREVIR (R494617) DRUG SUBSTANCE
Page 847
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 2/14/2013 AUROBINDO PHARMA LTD BOSENTAN MONOHYDRATE (NON-STERILE
DRUG SUBSTANCE)
### A III 1/30/2013 APTAR FRANCE SAS APTAR ELECTRONIC ANCILLARY COMPONENTS
### I III 1/30/2013 E-ONEMEDI CONTAINER & CLOSURE
### A IV 1/22/2013 TIANJIN BOKELIN MEDICAL PACKAGING SUITTAR
TECHNOLOGY CO LTD
### A IV 1/22/2013 TIANJIN BOKELIN MEDICAL PACKAGING NATRACOLOR
TECHNOLOGY CO LTD
### A II 2/7/2013 SYMED LABS LTD KETOROLAC TROMETHAMINE
### A II 2/4/2013 RA CHEM PHARMA LTD MIDAZOLAM USP
### A II 1/31/2013 ISOCHEM SAS ECONAZOLE NITRATE
### A II 2/1/2013 ZAKLADY FARMACEUTYCZNE SODIUM SALICYLATE
POLPHARMA SA
### I III 1/17/2013 HUHTAMAKI RONSBERG SIDE SEALED FLAT POUCH FOR DRUGS
APPLIED AS FAST DISSOLVING ORAL FILM
### A III 1/30/2013 ROCHLING MEDICAL NEUHAUS GMBH ROUND WHITE PE- BOTTLE 300 ML (P-4029)
AND CO KG
### A III 1/30/2013 ROCHLING MEDICAL NEUHAUS GMBH SQUARE WHITE PE- BOTTLE 300 ML (P 4030)
AND CO KG
### A II 5/20/2013 LUPIN LTD BIMATOPROST
### A II 4/19/2013 LUPIN LTD TRAVOPROST USP
### A II 4/12/2013 LUPIN LTD PRASUGREL HYDROCHLORIDE
### I II 3/21/2013 CI NATURMEGA SA OMEGA-3 FISH OIL ETHYL ESTER 84%
### A II 2/4/2013 ZHEJIANG LANGHUA PHARMACEUTICAL SPIRONOLACTONE
CO LTD
### A II 3/25/2013 USV PRIVATE LTD NATEGLINIDE USP [MICRONISED]
### A II 2/6/2013 SHANGHAI DESANO CHEMICAL MEFLOQUINE HYDROCHLORIDE
PHARMACEUTICAL CO LTD
### A IV 12/19/2012 HENKEL CORP DURO-TAK 87-9900 PRESSURE SENSITIVE
ADHESIVE
### A II 3/27/2013 GLENMARK PHARMACEUTICALS LTD SITAGLIPTIN PHOSPHATE ANHYDROUS
### A II 2/13/2013 INTERQUIM SA CELECOXIB
### A III 2/6/2013 CODING PRODUCTS SV-17809
### A III 2/11/2013 MULTISORB TECHNOLOGIES STABILOX HEAT SEAL LABEL
### A II 11/28/2012 CALYX CHEMICALS AND VALGANCICLOVIR HYDROCHLORIDE
PHARMACEUTICALS LTD
### A II 3/4/2013 ZHEJIANG HUAHAI PHARMACEUTICAL CLOPIDOGREL BISULFATE USP
CO LTD
### A II 4/17/2013 SHENZHEN TECHDOW ENOXAPARIN SODIUM USP
PHARMACEUTICAL CO LTD
### A II 2/26/2013 KD PHARMA BEXBACH GMBH EICOSAPENTAENOIC ACID ETHYL ESTER
### I II 3/14/2014 CHEM WERTH INC FULVESTRANT
### A II 7/30/2014 CHEMWERTH INC ABIRATERONE ACETATE
### A II 3/1/2013 ULTRAGENYX PHARMACEUTICAL INC TRIHEPTANOIN ULTRAPURE
### A III 2/14/2013 SCHOTT KAISHA PVT LTD GLASS AMPOULES & VIALS
Page 848
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 2/13/2013 EVONIK CORP 100 DL MPEG 5000
### I IV 2/12/2013 KERRY INGREDIENTS AND FLAVOURS 9000188 NAT MASKING FLAVOR
DBA MASTERTASTE INC
### I IV 2/18/2013 FONA INTERNATIONAL INC 877.237 MINT FLAVOR, NAT & ART
### A III 2/20/2013 CADILLAC PRODUCTS PACKAGING CO COMMERCIAL N
### A II 3/26/2013 ALKEM LABORATORIES LTD DRONEDARONE HYDROCHLORIDE
### I III 2/15/2013 SHL PHARMA LLC EPINEPHRINE AUTO-INJECTOR
### A IV 2/13/2013 UNGERER AND CO ARTIFICIAL BANANA FLVP FT-8072
### A II 2/27/2013 APOTEX FERMENTATION INC SIROLIMUS DRUG SUBSTANCE
### A IV 2/13/2013 UNGERER AND CO NAT/ART CREME DE VANILLA FLVP FT-8073
### A II 3/21/2013 TARO PHARMACEUTICAL INDUSTRIES ATOVAQUONE USP, MICRONIZED
LTD
### A IV 2/13/2013 UNGERER AND CO ARTIFICAL CARAMEL FLAVOR FV-8873
### A II 3/26/2013 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET-10275261]
26911 I II 2/21/2013 MAC CHEM PRODUCTS INDIA PVT LTD EXEMESTANE
### A II 9/9/2013 ABX ADVANCED BIOCHEMICAL EXAMETAZIME
COMPOUNDS BIOMEDIZINISCHE
FORSCHUNGSREAGENZIEN GMBH
### A II 2/20/2013 NOSCH LABS PRIVATE LTD RABEPRAZOLE SODIUM
### A II 2/21/2013 NOSCH LABS PRIVATE LTD LANSOPRAZOLE, USP
### A V 2/21/2013 ACS DOBFAR SPA STERILE FINISHED PRODUCTS AND STERILE
PROCESSING OPERATIONS STERILE PLANT
NO.3
### A III 2/25/2013 MULTIPLAST POLYMER PVT LTD PLASTIC HDPE BOTTLES FOR
PHARMACEUTICAL USE
### A III 2/22/2013 AMCOR FLEXIBLES BURGDORF GMBH COMPOUND PACKAGING MATERIAL
PAPER/ALUMINIUM/BAREX
### A II 2/26/2013 SYNBIAS PHARMA AG VALRUBICIN USP
### I II 2/25/2013 DISHMAN PHARMACEUTICALS AND TOPIRAMATE USP
CHEMICALS LTD
### A III 2/21/2013 LANXESS DEUTSCHLAND GMBH LANXESS BROMOBUTYL 2230
### I II 2/26/2013 MAPRIMED SA ARIPIPRAZOLE
### A II 3/30/2013 BIOPHORE INDIA PHARMACEUTICALS TRETINOIN
PVT LTD
### A II 5/16/2013 MEDICHEM SA MED-200056/E
### A II 4/29/2013 MEDICHEM MANUFACTURING MALTA SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
LTD
### A II 3/25/2013 GLENMARK PHARMACEUTICALS LTD PRASUGREL HYDROCHLORIDE
### A II 9/27/2013 SPECTRUM PHARMACEUTICALS INC BELINOSTAT DRUG SUBSTANCE
### A II 3/26/2013 JUBILANT GENERICS LTD ESLICARBAZEPINE ACETATE
### A II 3/28/2013 JUBILANT GENERICS LTD LINEZOLID FORM 1
### A II 3/29/2013 JUBILANT GENERICS LTD OLMESARTAN MEDOXOMIL USP
### A III 2/27/2013 SURYA POLYCONTAINER PLASTIC HDPE & PP BOTTLES & CLOSURES &
PLUGS
### A II 3/14/2013 WISDOM PHARMACEUTICAL CO LTD FLUPIRTINE MALEATE
Page 849
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 2/27/2013 MEDIPHARMAPLAN CO LTD MP-3000 (NON-PVC MEDICAL TUBE FOR IV
SOLUTION BAG) MP-5000 (NON-PVC MEDICAL
FILM FOR IV SOLUTION & BLOOD BAG)
### A II 3/31/2013 EMCURE PHARMACEUTICALS LTD COLESEVELAM HYDROCHLORIDE
### I II 3/28/2013 EMCURE PHARMACEUTICALS LTD RALTEGRAVIR POTASSIUM
### A II 2/28/2013 NEULAND LABORATORIES LTD BRINZOLAMIDE USP (STERILE)
### A II 3/5/2013 FARMABIOS SPA LOTEPREDNOL ETABONATE
### A II 2/14/2014 GLENMARK PHARMACEUTICALS LTD ESOMEPRAZOLE MAGNESIUM DIHYDRATE
(D058 PROCESS)
### I III 11/24/2014 STULL TECHNOLOGIES PACKAGING MATERIAL
### A II 4/11/2013 ARIAD PHARMACEUTICALS INC RIDAFOROLIMUS DRUG SUBSTANCE
### A IV 2/28/2013 LONZA INC POLYGLYCEROL-6
### I II 3/14/2013 WISDOM PHARMACEUTICAL CO LTD TIROFIBAN HYDROCHLORIDE
### I II 3/4/2013 ZHEJIANG YIZHOU CHEMICAL CO LTD TYRAMINE HYDROCHLORIDE (VERSION NO.:1)
### A II 2/28/2013 CODING PRODUCTS TTR-76356
### A II 3/4/2013 PROCOS SPA ILOPERIDONE
### A II 3/4/2013 AK AND MN BIOFARM CO LTD EPA ETHYL ESTER 70
### A II 3/31/2013 EMCURE PHARMACEUTICALS LTD ENOXAPARIN SODIUM USP
### A II 3/29/2013 EMCURE PHARMACEUTICALS LTD DECITABINE MONOHYDRATE
### A II 3/30/2013 EMCURE PHARMACEUTICALS LTD PANTOPRAZOLE SODIUM USP
### A II 6/11/2013 EMCURE PHARMACEUTICALS LTD TRIMETHOBENZAMIDE HYDROCHLORIDE USP
### A II 3/30/2013 AUROBINDO PHARMA LTD PRASUGREL HYDROCHLORIDE (NON-STERILE
DRUG SUBSTANCE)
### A III 2/28/2013 PROMENS HF AIR FREE VINCI AND AIR FREE VEGA
### I II 3/7/2013 ZHEJIANG JIUZHOU PHARMACEUTICAL 10- METHOXY IMINOSTILBENE (VERSION NO.:1)
CO LTD
### A II 3/9/2013 SAURAV CHEMICALS LTD DIETHYLCARBAMAZINE CITRATE
### A II 3/6/2013 RECORDATI INDUSTRIA CHIMICA E CARGLUMIC ACID
FARMACEUTICA SPA
### A II 3/29/2013 MSN LABORATORIES PRIVATE LTD DRONEDARONE HYDROCHLORIDE USP [ROUTE
CODE-DD]
### A II 4/6/2013 MSN LABORATORIES PRIVATE LTD SILODOSIN [ROUTE CODE - "SD"]
### A II 3/30/2013 MSN LABORATORIES PRIVATE LTD PRASUGREL HYDROCHLORIDE [ROUTE CODE -
"PR"]
### A II 3/9/2013 SAURAV CHEMICALS LTD DEXKETOPROFEN TROMETAMOL
### A III 2/25/2013 COSTER TECHNOLOGIE SPECIALI SPA 20MM AEROSOL VALVES
### A II 3/18/2013 OLON SPA PIROXICAM
### A II 3/3/2013 ZHEJIANG NEO DANKONG LINEZOLID (FORM I), NON-STERILE BULK DRUG
PHARMACEUTICAL CO LTD SUBSTANCE
### A II 6/28/2013 LUPIN LTD DRONEDARONE HYDROCHLORIDE USP
### I III 3/9/2013 ALUTECH PACKAGING PVT LTD PLAIN, COLOURED AND/OR PRINTED ALU- ALU
FOIL "SILPACK" TM PACKAGING MATERIAL AND
ALUMINIUM FOILS FOR PHARMACEUTICAL,
MEDICAL, BIOLOGICAL AND FOOD INDUSTRY
Page 850
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 3/8/2013 CHANGZHOU PHARMACEUTICAL AGOMELATINE
FACTORY
### A II 1/29/2013 FINECURE PHARMACEUTICALS LTD FINEMOX CV 625 (CO- AMOXICLAV TABLETS BP
625 MG)
### A II 3/5/2013 RAKS PHARMA PVT LTD ESCITALOPRAM OXALATE, USP
### A II 12/6/2013 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET-10275266]
### I II 3/6/2013 FRESENIUS KABI ANTI INFECTIVES SRL CEPHAPIRIN BENZATHINE STERILE
### A II 12/8/2012 OMKAR SPECIALITY CHEMICALS LTD SELENIUM SULFIDE
### A II 3/4/2013 ZHEJIANG JIANGBEI PHARMACEUTICAL SIMVASTATIN
CO LTD
### A II 4/1/2013 MSN LABORATORIES PRIVATE LTD EZETIMIBE USP [ROUTE CODE - EZ]
### A II 3/23/2013 MSN ORGANICS PRIVATE LTD ASENAPINE MALEATE [ROUTE CODE "AOI"]
### A II 4/5/2013 MSN PHARMACHEM PRIVATE LTD SITAGLIPTIN PHOSPHATE ANHYDROUS [ROUTE
CODE - SA"]
### A II 4/29/2013 MSN LABORATORIES PRIVATE LTD ALISKIREN HEMIFUMARATE [ROUTE CODE -
"AF"]
### A II 3/26/2013 ALEMBIC PHARMACEUTICALS LTD DRONEDARONE HYDROCHLORIDE USP
### A II 5/3/2013 GLENMARK PHARMACEUTICALS LTD SAXAGLIPTIN MONOHYDRATE
### A II 6/21/2013 TEVA PHARMACEUTICAL INDUSTRIES CASPOFUNGIN ACETATE
LTD
### I II 3/15/2013 ZHEJIANG JIUZHOU PHARMACEUTICAL V5537 (3-(2-AMINOETHYL)-2-METHYL-6,7,8,9-
CO LTD TETRAHYDRO-4H-PYRIDO{1,2-A}PYRIMIDINE-4-
ONE,DIHYDROCHLORIDE)(VERSION NO.:1)
### I II 3/15/2013 ZHEJIANG ZONE BANNER CHEMICAL CO 1-[2-AMINO-1-(4-METHOXYPHENYL)ETHYL]-
LTD CYCLOHEXANOL HYDROCHLORIDE (VERSION
NO.:1)
### A III 2/14/2012 SANWARIYA PACKAGING PVT LTD PRINTED BLISTER ALUMINIUM FOIL FOR
PHARMACEUTICAL USE
### I II 3/12/2013 ZHEJIANG ZONE BANNER CHEMICAL CO 2-(3-BENZOYLPHENYL) PROPANENITRILE
LTD (VERISION NO.:1)
### A II 3/14/2013 HANGZHOU HUADONG MEDICINE SIROLIMUS (INTERMEDIATE)
GROUP KANGRUN PHARMACEUTICAL
CO LTD
### A II 3/12/2013 EDMOND PHARMA SRL DEXMEDETOMIDINE HCI
### I III 3/6/2013 MS JINDAL ALUMINIUM LTD HEAT SEAL LACQUER COATED BLISTER FOIL
(PLAIN /PRINTED)
### I III 2/27/2013 LINHARDT GMBH AND CO KG LAMINATED TUBES FOR THE COSMETIC,
PHARMACEUTICAL OR FOOD SECTOR
### I III 3/6/2013 MS JINDAL ALUMINIUM LTD POLY LAMINATED STRIP FOIL (PLAIN /PRINTED)
### I III 3/6/2013 MS JINDAL ALUMINIUM LTD BARE ALUMINIUM FOIL
### I III 3/6/2013 MS JINDAL ALUMINIUM LTD PRINTED ALUMINIUM FOIL
### I III 3/6/2013 MS JINDAL ALUMINIUM LTD OPA (ORIENTED POLY AMIDE) / ALUMINIUM
FOIL/PVC LAMINATE
### A III 3/15/2013 CHROMA CORP PC302483C PINK COLOR CONCENTRATE
### A II 3/20/2013 HETERO LABS LTD OLMESARTAN MEDOXOMIL
Page 851
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 3/29/2013 ZHEJIANG HISUN PHARMACEUTICAL CO CAPECITABINE USP
LTD
### I III 3/19/2013 DAIKIN INDUSTRIES LTD NEOFLON PCTFE FILM
### A II 3/15/2013 ERREGIERRE SPA ZILEUTON USP
### A II 3/7/2013 ULKAR KIMYA SANAYII VE TICARET AS CANDESARTAN CILEXETIL USP
### A II 3/7/2013 ULKAR KIMYA SANAYII VE TICARET AS PANTOPRAZOLE SODIUM SESQUIHYDRATE USP
Page 852
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 4/2/2013 MAC CHEM PRODUCTS INDIA PVT LTD ROPIVACAINE HYDROCHLORIDE
MONOHYDRATE USP
### A II 4/2/2013 MAC CHEM PRODUCTS INDIA PVT LTD OXALIPLATIN USP
### I III 4/1/2013 COLORS FOR PLASTICS INC R34215 RED/1797C COLORANT MASTERBATCH
### I II 3/25/2013 GW PHARMA LTD GWP42003-P
### A II 4/1/2013 UNIMAX CHEMICALS PVT LTD ERYTHROMYCIN (HIGH PURITY)
### A II 3/29/2013 JOHNSON MATTHEY PHARMA SERVICES 4235.D
### A II 4/3/2013 KYONGBO PHARMACEUTICAL CO LTD CEFIXIME BULK
### A III 3/25/2013 SVAM PACKAGING INDUSTRIES PVT LTD ALUBLIS/TROBLIS COLD FORMING BLISTER FOIL
(ALU-ALU FOIL)
### A II 3/29/2013 CONTIPRO AS SODIUM HYALURONATE
### A II 7/10/2013 SPECGX LLC COMPAP SDCRSL
### A II 6/29/2013 MSN LABORATORIES PRIVATE LTD DABIGATRAN ETEXILATE MESYLATE [ROUTE
CODE - "DE"]
### A II 4/20/2013 MSN PHARMACHEM PRIVATE LTD DARUNAVIR [ROUTE CODE - "DI"]
### A II 5/16/2013 MSN ORGANICS PRIVATE LTD ILOPERIDONE [ROUTE CODE - "IO"]
### A II 5/16/2013 MSN PHARMACHEM PRIVATE LTD VILDAGLIPTIN [ROUTE CODE - "VG"]
### A II 5/28/2013 MSN PHARMACHEM PRIVATE LTD MONTELUKAST SODIUM USP [ROUTE CODE -
"MK"]
### A II 5/31/2013 MSN LABORATORIES PRIVATE LTD ERLOTINIB HYDROCHLORIDE [ROUTE CODE -
"ER"]
### A II 5/30/2013 MSN LABORATORIES PRIVATE LTD GEMCITABINE HYDROCHLORIDE USP [ROUTE
CODE - "GH"]
### A II 5/29/2013 MSN LABORATORIES PRIVATE LTD BIMATOPROST [ROUTE CODE - "BM"]
### A II 4/19/2013 SRI KRISHNA PHARMACEUTICALS LTD GLYBURIDE USP
### A II 9/16/2013 MACLEODS PHARMACEUTICALS LTD DARIFENACIN HYDROBROMIDE
### A II 6/12/2013 TEVA PHARMACEUTICAL INDUSTRIES PRASUGREL HYDROCHLORIDE
LTD
### A II 4/3/2013 HAINAN YEW PHARMACEUTICAL CO LTD PACLITAXEL (SEMI-SYNTHETIC)
### I III 4/1/2013 LOTTE CHEMICAL J-560M
### I II 4/1/2013 ST GOBAIN PERFORMANCE PLASTICS C- FLEXr R70-082 TPE TUBING
CORP
### A II 4/3/2013 HETERO DRUGS LTD TOLVAPTAN
### A III 3/27/2013 COLORTECH INC 11616-18 WHITE POLYETHYLENE CONCENTRATE
### A III 4/2/2013 SHANDONG LINUO TECHNICAL NEUTRAL BOROSILICATE GLASS AMPOULE
GLASSWORK CO LTD
Page 854
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 4/2/2013 SHANDONG LINUO TECHNICAL NEUTRAL BOROSILICATE GLASS TUBULAR VIAL
GLASSWORK CO LTD
### A II 4/19/2013 ZHEJIANG LIAOYUAN (+)-METHYL-(2-CHLOROPHENYL)-(2-THIOPHEN-
PHARMACEUTICALS CO LTD 2YL-ETHYLAMINO) ACETATE HYDROCHLORIDE
### A II 8/2/2013 MEGHMANI LLP ACETAMINOPHEN, USP
### I III 3/14/2013 VERSALIS SPA ERACLENE MP 90U
### I III 3/14/2013 VERSALIS SPA ERACLENE BB 82
### I III 4/19/2013 TECTUBES SWEDEN AB PLASTIC AND ALMINUM TUBES
### A II 5/13/2013 SUN PHARMACEUTICAL INDUSTRIES DRONEDARONE HYDROCHLORIDE
LTD
### A III 4/22/2013 BD MEDICAL - PHARMACEUTICAL BD NEOPAK (STERILE) SYRINGE SYSTEM
SYSTEMS
### A II 5/10/2013 SUN PHARMACEUTICAL INDUSTRIES PRASUGREL HYDROCHLORIDE
LTD
### A II 4/26/2013 PIRAMAL ENTERPRISES LTD METAXALONE
### A II 5/7/2013 AUROBINDO PHARMA LTD PITAVASTATIN CALCIUM (NON-STERILE DRUG
SUBSTANCE)
### A II 4/24/2013 TRIFARMA SPA ZOLEDRONIC ACID
### A III 4/15/2013 BOREALIS AG BORMED LE6607-PH
### A II 4/20/2013 HEC PHARM CO LTD ENTACAPONE NON-STERILE BULK DRUG
SUBSTANCE
27110 A II 7/29/2013 ABX ADVANCED BIOCHEMICAL ABX-[18F]FDG CASSETTE FOR GE TRACERLAB
COMPOUNDS GMBH MX SYNTHESIZER
27111 A II 5/9/2013 AUROBINDO PHARMA LTD SAXAGLIPTIN MONOHYDRATE (NON-STERILE
DRUG SUBSTANCE)
27112 I IV 4/29/2013 FONA INTERNATIONAL INC 915.0642U N-C STRAWBERRY FLAVOR, ART
27113 A III 4/12/2013 KEY INTERNATIONAL INC PLASTIC POLYMER ALLOY
27114 I II 4/18/2013 JIANSHI YUANTONG BIOENGINEERING HESPERIDIN
CO LTD
27115 A II 4/22/2013 CHIRAL QUEST SUZHOU CO LTD (R)-3-(TERT-BUTOXYCARBONYLAMINO)-4-(2,4,5-
TRIFLUOROPHENYL) BUTANOIC ACID
27116 A II 6/4/2013 FIS FABBRICA ITALIANA SINTETICI SPA LENALIDOMIDE
27117 A II 4/30/2013 BELLICUM PHARMACEUTICALS INC AP1903 INJECTION
27118 I III 4/9/2013 AXIUM PLASTICS HDPE BOTTLES
27119 A II 5/1/2013 HETERO DRUGS LTD PRASUGREL HYDROCHLORIDE
### A II 4/30/2013 INDUSTRIALE CHIMICA SRL TIOTROPIUM BROMIDE METHANOL SOLVATE
### A II 4/29/2013 COVALENT LABORATORIES PRIVATE LTD CEFIXIME USP
Page 855
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 5/15/2013 VORA PACKAGING PVT LTD BOTTLE CAP SEALS & LINERS (EXPANDED
POLYETHYLENE CAP LINERS & INDUCTION
HEAT SEALS)
### A II 7/22/2013 EPAX NORWAY AS EPAX 6015 TGN US API
### A III 5/3/2013 BEYONDEVICES SA VAGINAL APPLICATOR
### A II 4/26/2013 ONO PHARMACEUTICAL CO LTD ALPROSTADIL ALFADEX
### A II 6/2/2000 NEKTAR THERAPEUTICS METHOXYPOLY (ETHYLENE GLYCOL)-
SUCCINIMIDYL CARBONATE, MW 12,000
### A II 5/22/2013 ZHEJIANG HUAHAI PHARMACEUTICAL TOLVAPTAN
CO LTD
### A II 5/2/2013 ZHEJIANG CHARIOTEER GANCICLOVIR USP (NON-STERILE API)
PHARMACEUTICAL CO LTD
### I IV 5/1/2013 NUSIL TECHNOLOGY LLC DDU-4353 SILICONE
### A II 5/31/2013 APOTEX PHARMACHEM INDIA PVT LTD TETRABENAZINE
### A III 5/17/2011 THE JENARD CO DIV FEY INDUSTRIES SLEEVE FOR THE PROTECTION OF A MULTI-
INC DOSAGE PHARMACEUTICAL BLISTER PACKAGE
### I III 5/2/2013 JAUSS POLYMER LTD PET BOTTLES FOR PHARMACEUTICALS
### A II 11/10/2000 NEKTAR THERAPEUTICS METHOXYPOLY (ETHYLENE GLYCOL)-
PROPIONALDEHYDE, MW 20, 000
### A II 5/6/2013 IOL CHEMICALS AND METFORMIN HYDROCHLORIDE
PHARMACEUTICALS LTD
### A II 4/25/2013 QILU TIANHE PHARMACEUTICAL CO LTD TAZOBACTAM SODIUM (STERILE API)
### A II 10/31/1980 HEMISPHERX BIOPHARMA INC ALFERON N INJECTION
### A II 5/8/2013 ACEBRIGHT INDIA PHARMA PRIVATE LTD TENOFOVIR DISOPROXIL FUMARATE [DRUG
SUBSTANCE(NON-STERILE)]
### A II 6/25/2013 MYLAN LABORATORIES LTD PITAVASTATIN CALCIUM
### I II 5/4/2013 MICROBIOPHARM JAPAN CO LTD PARICALCITOL, USP
### A II 6/26/2013 MYLAN LABORATORIES LTD SAXAGLIPTIN HYDROCHLORIDE
### A II 6/28/2013 MYLAN LABORATORIES LTD TETRABENAZINE
### A III 1/9/2013 CHING HAI CHEMICAL INDUSTRIAL CO SILICA GEL
LTD
### I II 12/14/1988 BACHEM AG (H-GLY-HIS-LYS-OH) 2 COPPER CHELATE
### I II 1/29/1993 ARES SERVICES SA INTERFERON-BETA AND INTERLEUKIN-6"
### I II 2/6/1987 PENINSULA LABS INC D-ALA-8-THR-NH2
### I II 10/19/1990 CARLBIOTECH LTD A S PEPTIDE-T
### I II 11/4/1997 MAYO CLINIC HUMAN GRANULOCYTE-MACROPHAGE
COLONY-STIMULATING FACTOR (IMMUNEX),
AEROSOL
### I II 11/4/1988 GOODWIN INST CRUDE MOUSE ASCITES CONTAINING
MONOCLONAL ANTIBODIES
### A II 11/10/2015 ABBVIE INC ERYTHROMYCIN BASE
### A II 6/14/2013 XELLIA PHARMACEUTICALS APS CASPOFUNGIN (ACETATE)
### I II 8/5/1996 SCIOS INC FIBLAST TRAFERMIN FOR INJECTION
(RECOMBINANT HUMAN BASIC FIBROBLAST
GROWTH FACTOR, RHBFGF)
Page 856
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 5/22/1987 BEECHAM LABORATORIES APSAC (ANISOYLATED PLASMINOGEN
STREPTOKINASE COMPLEX - BRL26921)
### A II 5/21/2013 RAKS PHARMA PVT LTD TRAMADOL HYDROCHLORIDE USP API
(PROCESS-2)
### I II 4/15/1983 SHELL OIL CO RECOMBINANT HUMAN INTERFERON, BETA
### A II 5/31/2013 RAKS PHARMA PVT LTD DRONEDARONE HYDROCHLORIDE USP
### A II 8/6/2013 INDENA SPA PACLITAXEL/S SEMISYNTHETIC PROCESS,
USP/EP
### A V 3/28/2013 WEST PHARMACEUTICAL SERVICES INC DAIKYO CRYSTAL ZENITH READY-TO-USE
CARTRIDGE SYSTEM
### A II 5/21/2013 AMOLI ORGANICS PVT LTD OLMESARTAN MEDOXOMIL USP
### A II 5/22/2013 AMRI RENSSELAER INC DIATRIZOATE MEGLUMINE, USP
### I II 6/28/2013 DR REDDYS LABORATORIES LTD ESZOPICLONE [PROCESS-3]
### I II 5/31/2013 APOTEX PHARMACHEM INDIA PVT LTD EXEMESTANE
### A II 6/11/2013 AUROBINDO PHARMA LTD MEROPENEM (NON-STERILE DRUG SUBSTANCE
INTERMEDIATE)
### A II 12/12/2013 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET-00775174]
### I II 7/3/2013 MEDICHEM MANUFACTURING MALTA BEPOTASTINE BESILATE
LTD
### I II 5/31/2013 APOTEX PHARMACHEM INDIA PVT LTD OLOPATADINE HYDROCHLORIDE USP
### I II 5/6/2013 NEWGEN BIOTECH INC SERRAPEPTASE
### I II 5/6/2013 NEWGEN BIOTECH INC BROMELAIN
### A II 6/27/2013 TEVA PHARMACEUTICAL INDUSTRIES SAXAGLIPTIN MONOHYDRATE
LTD
### A III 8/28/2013 FRANPLAST SPA CHEMITON HMB SERIES
### A III 5/13/2013 CHROMA CORP PC23258B WHITE COLOR CONCENTRATE
### A III 5/13/2013 CHROMA CORP PC23258A WHITE COLOR CONCENTRATE
### A III 5/13/2013 CHROMA CORP PC56252C BLUE COLOR CONCENTRATE
### A II 7/16/2013 XELLIA PHARMACEUTICALS APS DAPTOMYCIN NON-STERILE
### A II 5/24/2013 HARMAN FINOCHEM LTD LIDOCAINE USP
### A II 6/7/2013 NEW ZEALAND PHARMACEUTICALS LTD CHOLIC ACID
### A II 5/23/2013 FINORGA SAS ICOSAPENT ETHYL
### A III 5/9/2013 CANADA COLORS AND CHEMICALS LTD WHITE MB50-949POLYPROPYLENE COLOUR
DBA CCC PLASTICS CONCENTRATE
### A IV 5/15/2013 NOVO EXCIPIENTS PVT LTD NOVOMIX
### A II 7/17/2013 SUN PHARMACEUTICAL INDUSTRIES ASENAPINE MALEATE
LTD
### A II 8/9/2013 SUN PHARMACEUTICAL INDUSTRIES TETRABENAZINE
LTD
### I II 6/24/2013 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET-10275265]
### A II 9/13/2013 CEDARBURG PHARMACEUTICALS INC RIBOFLAVIN 5'-PHOSPHATE SODIUM
### A II 6/14/2013 RAKS PHARMA PVT LTD SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
### A II 9/2/2013 RAKS PHARMA PVT LTD OMEPRAZOLE MAGNESIUM, USP
### A IV 5/15/2013 NOVO EXCIPIENTS PVT LTD NOVOPOWER
### A II 6/18/2013 AURONEXT PHARMA PRIVATE LTD MEROPENEM FOR INJECTION (STERILE BULK)
Page 857
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 5/5/2013 TULSTAR PRODUCTS INC PCTFE RESIN
### A II 7/4/2013 ALEMBIC PHARMACEUTICALS LTD ASENAPINE MALEATE
### I II 5/24/2013 TIANJIN TIANYAO PHARMACEUTICALS DEXAMETHASONE SODIUM PHOSPHATE
CO LTD
### A II 5/30/2013 HOVIONE FARMACIENCIA SA BECLOMETHASONE DIPROPIONATE
MONOHYDRATE USP
### A II 5/30/2013 HETERO DRUGS LTD RISEDRONATE SODIUM HEMI-PENTAHYDRATE,
USP
### A II 6/10/2013 ZHEJIANG HUAHAI PHARMACEUTICAL LOSARTAN POTASSIUM USP
CO LTD
### A IV 5/15/2013 FRUTAROM USA CHERRY SPRAY DRIED NATURAL FLAVOR
3209187501.00
### A III 5/29/2013 MEYER SEALS ALFELDER CLOSURE LINERS
KUNSTSTOFFWERKE HERM MEYER
GMBH
### A II 7/5/2013 APOTEX PHARMACHEM INDIA PVT LTD SAXAGLIPTIN HCI WITH MANNITOL
COPRECIPITATE 20%
### A II 6/27/2013 HISUN PHARMACEUTICAL HANGZHOU TACROLIMUS USP
CO LTD
### A IV 6/5/2013 FONA INTERNATIONAL INC 915.0213U N-C FRESH STRAWBERRY FLAVOR,
ART
### A II 6/17/2013 AARTI INDUSTRIES LTD BUPROPION HYDROCHLORIDE
### A II 6/15/2013 MSN LABORATORIES PRIVATE LTD BENDAMUSTINE HYDROCHLORIDE [ROUTE
CODE - "BH"]
### A II 6/21/2013 MSN PHARMACHEM PRIVATE LTD AGOMELATINE [ROUTE CODE - AG1"]
### A II 6/10/2013 SHANGHAI SHYNDEC ZIDOVUDINE
PHARMACEUTICAL HAIMEN CO LTD
### A II 7/12/2013 RHODES TECHNOLOGIES INC METHYLPHENIDATE HCL USP
### A II 7/1/2013 ALAND JIANGSU NUTRACEUTICAL CO ASCORBIC ACID, USP, PH. EUR
LTD
### I II 6/3/2013 SYMBIOTICA SPECIALITY INGREDIENTS BETHAMETHASONE VALERATE
SDN BHD
27211 A II 6/28/2013 DR REDDYS LABORATORIES LTD CINACALCET HYDROCHLORIDE
### A II 6/28/2013 DR REDDYS LABORATORIES LTD SAXAGLIPTIN HYDROCHLORIDE
### A II 9/12/2013 DR REDDYS LABORATORIES LTD TERT-BUTYL((S)-2-((1S,3S,5S)-3-CYANO-2-
AZABICYCLO[3.1.0]HEXAN-2-YL)1-((1R,
3R,5R,7S)-3-HYDROXYADAMANTAN-1-YL)-2-
OXOETHYL)CARBAMATE
### A II 6/20/2013 MSN PHARMACHEM PRIVATE LTD APREPITANT USP (FORM-II) [ROUTE CODE -
"AP2"]
### A II 6/12/2013 AMBIOPHARM INC LIRAGLUTIDE, NON-STERILE, BULK DRUG
SUBSTANCE
### A II 7/1/2013 CHUNGHWA CHEMICAL SYNTHESIS AND EVEROLIMUS
BIOTECH CO LTD
### A II 6/14/2013 SCINOPHARM TAIWAN LTD BIMATOPROST
Page 858
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 6/26/2013 HISUN PHARMACEUTICAL HANGZHOU PNEUMOCANDIN B0
CO LTD
### A II 7/9/2013 ZHEJIANG HISUN PHARMACEUTICAL CO OLANZAPINE USP
LTD
### A III 6/17/2013 CILICANT CHEM PRIVATE LTD DESICCANT POUCH
### A III 7/1/2013 COSPACK PLASTICS PRODUCTS CO LTD LAMINATE TUBES & COLLAPSIBLE PLASTIC
TUBES FOR PHARMACEUTICAL PACKAGING
### A II 9/6/2013 ALP PHARM BEIJING CO LTD CALCIPOTRIENE HYDRATE
### A II 6/29/2013 EMCURE PHARMACEUTICALS LTD DRONEDARONE HYDROCHLORIDE
### A II 6/29/2013 EMCURE PHARMACEUTICALS LTD PERPHENAZINE USP
### I II 6/15/2013 SHANGHAI SINE PHARMACEUTICAL RABEPRAZOLE SODIUM
LABORATORIES CO LTD
### A IV 6/18/2013 EVONIK CORP POLY(D, L-LACTIDE CO-CAPROLACTONE) AND
POLY(L-LACTIDE-CO-CAPROLACTONE)
### I III 6/11/2013 AMPACET CORP 466276-KQ MYLAN BLUE SLIP 276
### I III 6/11/2013 AMPACET CORP 111343 BLUE WHITE PE MB
### A II 6/4/2013 HEBEI HUARONG PHARMACEUTICAL CO HYDROXOCOBALAMIN ACETATE
LTD
### A II 6/27/2013 INTAS PHARMACEUTICALS LTD PRASUGREL HYDROCHLORIDE
### A II 6/19/2013 HETERO LABS LTD SIMVASTATIN, USP (PROCESS II)
### A II 6/19/2013 HETERO LABS LTD PRALATREXATE
### A II 7/30/2013 CADILA HEALTHCARE LTD LINEZOLID
### A II 7/9/2013 AUROBINDO PHARMA LTD MONTELUKAST SODIUM USP (NON-STERILE
DRUG SUBSTANCE)
### I II 6/11/2013 YONSUNG FINE CHEMICALS CO LTD ISOPROPYL UNOPROSTONE
### A III 6/18/2013 SGD PHARMA INDIA LTD MOULDED GLASS VIALS USP -I
### A III 6/18/2013 SGD PHARMA INDIA LTD TUBULAR GLASS VIALS AND AMPOULES USP -I
### A III 6/21/2013 BESPAK DIV CONSORT MEDICAL PLC BK640 GENERIC ORAL INTEGRATED DOSE
COUNTER
### A II 6/29/2013 MSN PHARMACHEM PRIVATE LTD SAXAGLIPTIN HYDROCHLORIDE (DIHYDRATE)
[ROUTE CODE - "SH"]
### A II 6/29/2013 MSN LABORATORIES PRIVATE LTD VIGABATRIN USP [ROUTE CODE - "VB"]
### A II 9/27/2013 IPCA LABORATORIES LTD PROMETHAZINE HYDROCHLORIDE USP
### A II 7/23/2013 LUPIN LTD PITAVASTATIN CALCIUM
### I II 6/18/2013 SICHUAN DEEBIO PHARMACEUTICALS HEPARIN SODIUM
CO LTD
### A II 7/23/2013 CIPLA LTD MOMETASONE FUROATE MONOHYDRATE
### I II 7/25/2013 IPCA LABORATORIES LTD MESALAMINE USP (MZ3 PROCESS)
### A II 6/28/2013 JUBILANT GENERICS LTD TADALAFIL-USP
### I II 6/25/2013 TIANJIN SEGA PHARMA CO LTD LAMIVUDINE USP
### A II 6/4/2013 THE UNITED LABORATORIES INNER 6-AMINO-PENICILLANIC ACID (6-APA) BULK
MONGOLIA CO LTD DRUG SUBSTANCE
### A IV 6/4/2013 DMV FONTERRA EXCIPIENTS GMBH CO MICROCRYSTALLINE CELLULOSE (SPRAY
KG DRIED)
### A II 6/21/2013 CEDARBURG PHARMACEUTICALS INC FLUOXYMESTERONE A DRUG SUBSTANCE
Page 859
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 9/17/2013 CADILA HEALTHCARE LTD ESOMEPRAZOLE MAGNESIUM DIHYDRATE
(PROCESS II)
### A II 7/17/2013 IPCA LABORATORIES LTD RISEDRONATE SODIUM HEMI-PENTAHYDRATE
USP
### A II 7/24/2013 MYLAN LABORATORIES LTD RILPIVIRINE HYDROCHLORIDE
### A II 7/16/2013 HETERO DRUGS LTD PITAVASTATIN CALCIUM
### A II 9/20/2013 JUBILANT GENERICS LTD VORICONAZOLE USP
### A II 9/28/2013 JUBILANT GENERICS LTD PALIPERIDONE PALMITATE
### A II 7/15/2013 NANJING LIFENERGY R AND D CO LTD IRON SUCROSE
### A II 7/15/2013 AMINO CHEMICALS LTD ZIPRASIDONE HYDROCHLORIDE
MONOHYDRATE
### A II 7/29/2013 APICORE US LLC PRIMAQUINE PHOSPHATE, USP
### A II 6/21/2013 ZHEJIANG RAYBOW PHARMACEUTICAL CARBAMAZEPINE PROCESS B
CO LTD
### I IV 6/21/2013 NITIKA PHARMACEUTICAL SPECIALITIES CALCIUM STEARATE USP/NF
PVT LTD
### A III 6/12/2013 PEARL POLYMERS LTD PET BOTTLES FOR PHARMACEUTICALS
### A III 6/14/2013 ROBIN INDUSTRIES INC EY-111206
### A II 6/25/2013 HYBIO PHARMACEUTICAL CO LTD NESIRITIDE CITRATE, NON-STERILE BULK DRUG
SUBSTANCE
### A II 7/8/2013 ZHEJIANG HISOAR PHARMACEUTICAL CLINDAMYCIN HYDROCHLORIDE (PROCESS B)
CO LTD
### A IV 6/28/2013 KRATON POLYMERS US LLC DX401 JS STYRENE-ISOPRENE-STYRENE
COPOLYMER
### I II 7/2/2013 HETERO DRUGS LTD SAXAGLIPTIN HYDROCHLORIDE PREMIX
### A III 6/27/2013 SICHUAN HUILI INDUSTRY CO LTD ALUMINIUM FOIL FOR PHARMACEUTICAL
PACKAGING
### A III 6/27/2013 SICHUAN HUILI INDUSTRY CO LTD BOPET/VMPET/PE COMPOSITE FILM/BAG FOR
PHARMACEUTICAL PACKAGING
### A II 7/15/2013 ZHEJIANG HISOAR PHARMACEUTICAL CLINDAMYCIN PHOSPHATE (PROCESS B)
CO LTD
### A II 9/19/2013 NAVINTA LLC BENDAMUSTINE HYDROCHLORIDE
MONOHYDRATE
### A II 10/24/2013 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET-10275226]
### I II 3/24/2014 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET-10275268]
### A III 6/27/2013 SICHUAN HUILI INDUSTRY CO LTD POLYVINYL CHLORIDE/POLYVINYLIDENE
CHLORIDE (PVC/PVDC) COMPOSITE SHEET FOR
PACKAGING OF SOLID DOSAGE FORMS
### A II 9/22/2013 ZHEJIANG HISOAR PHARMACEUTICAL CLINDAMYCIN PALMITATE HYDROCHLORIDE
CO LTD (PROCESS B)
### A III 6/27/2013 SICHUAN HUILI INDUSTRY CO LTD POLYVINYL CHLORIDE (PVC) SHEET FOR
PHARMACEUTICAL PACKAGING
Page 860
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 6/27/2013 SICHUAN HUILI INDUSTRY CO LTD POLYAMIDE/ALUMINUM/POLYVINYL CHLORIDE
(PA/AL/PVC) COLD FORMING COMPOSITE
SHEET FOR PACKAGING OF SOLID DOSAGE
FORMS
### A III 6/27/2013 SICHUAN HUILI INDUSTRY CO LTD POLYESTER/ALUMINUM/CASTING
POLYPROPYLENE (PET/AL/CPP) COMPOSITE
FILM/BAG FOR PHARMACEUTICAL PACKAGING
### I II 7/1/2013 ZHEJIANG JIUZHOU PHARMACEUTICAL 1-[2-AMINO-1-(4-METHOXYPHENYL) ETHYL]
CO LTD CYCLOHEXANOL HYDROCHLORIDE (VERSION
NO.:1)
### I III 7/3/2013 TRUDELL MEDICAL INTERNATIONAL TOP MOUNTED ACTUATION INDICATOR (TMAI) -
P/N 102545
### A II 10/24/2013 GLAND PHARMA LTD INDOMETHACIN SODIUM USP
### A III 5/9/2013 ALPHA PHARMA DAMAN PRIVATE LTD PET BOTTLES
### A II 7/16/2013 BIOPHORE INDIA PHARMACEUTICALS FROVATRIPTAN SUCCINATE MONOHYDRATE
PVT LTD
### A II 12/31/2013 LUPIN LTD ASENAPINE MALEATE (MICRONIZED)
### I II 8/26/2013 UNICHEM LABORATORIES LTD TIAGABINE HYDROCHLORIDE USP
### A II 8/20/2013 UNICHEM LABORATORIES LTD PALIPERIDONE
### A III 6/28/2013 AMPACET CORP 7011641 AB PP MB
### A III 6/27/2013 SICHUAN HUILI INDUSTRY CO LTD POLYESTER/ALUMINUM/POLYETHYLENE
(PET/AL/PE) COMPOSITE FILM/BAG FOR
PHARMACEUTICAL PACKAGING
### I II 7/8/2013 CHEMO IBERICA SA ASENAPINE MALEATE
### A II 7/8/2013 SHISEIDO CO LTD SHISEIDO SODIUM HYALURONATE SZE GRADE-
EP
### A II 6/30/2013 MEGAFINE PHARMA P LTD ASENAPINE MALEATE (NON-STERILE DRUG
SUBSTANCE)
### A II 7/3/2013 FARMABIOS SPA TIROFIBAN HYDROCHLORIDE MONOHYDRATE
### A IV 7/5/2013 LIPOID GMBH LIPOID PG 14:0/14:0 NH4 (DMPG-NH4)
### I II 7/10/2013 TEVA PHARMACEUTICAL INDUSTRIES AZITHROMYCIN MONOHYDRATE
LTD
### A III 6/28/2013 TIANJIN BOKELIN MEDICAL PACKAGING G60T-002
TECHNOLOGY CO LTD
### A II 7/19/2013 3D IMAGING DRUG DESIGN AND FLUOROMISONIDAZOLE F 18 INJECTION
DEVELOPMENT LLC
### A II 8/23/2013 TEVA PHARMACEUTICAL INDUSTRIES PRALATREXATE
LTD
### A II 8/8/2013 SIGMAPHARM LABORATORIES LLC ASENAPINE MALEATE AMORPHOUS (31.2%)
PREMIX
### A II 10/1/2013 3D IMAGING DRUG DESIGN AND DPA-713 I 124 INJECTION
DEVELOPMENT LLC
### A II 7/29/2013 AUROBINDO PHARMA LTD ARMODAFINIL
### A II 9/27/2013 GLENMARK PHARMACEUTICALS LTD EZETIMIBE (D067 PROCESS)
Page 861
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 7/1/2013 LORMAC INDUSTRIAL DISTRIBUTORS LRMAC 3A POLYETHYLENE
LTD
### A IV 7/8/2013 UNGERER AND CO ARTIFICIAL JUICY RASPBERRY FLAVOR FW-4870
Page 862
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 9/27/2013 JIANGSU HENGRUI MEDICINE CO LTD FONDAPARINUX SODIUM USP, NON-STERILE
BULK DRUG SUBSTANCE
### A III 7/17/2013 WITTENBURG BV CAWITON MO SERIES FOR MEDICAL &
PHARMACEUTICAL USE
### A III 7/24/2013 WITTENBURG BV CAWITON MT-SERIES FOR MEDICAL &
PHARMACEUTICAL APPLICATIONS
### A II 7/18/2013 POLYMED THERAPEUTICS INC CABAZITAXEL ETHYL ACETATE SOLVATE DRUG
SUBSTANCE
### A II 9/20/2013 FIS FABBRICA ITALIANA SINTETICI SPA PRASTERONE ACETATE
### I II 10/17/1994 TOSOH BIOSCIENCE LLC TOYOPEARL(R) CHROMATOGRAPHIC RESINS
### A III 7/24/2013 PAOLO GOBBI FRATTINI SRL PLASTIC BAGS FOR PHARMACEUTICAL
SOLUTIONS AND THEIR COMPONENTS
### I IV 7/25/2013 KERRY BIOFUNCTIONAL INGREDIENTS LUBRITOSE MANNITOL
INC
### A III 7/10/2013 SCORPION CONTAINERS PRIVATE LTD FLIP OFF SEALS
### A III 7/10/2013 SCORPION CONTAINERS PRIVATE LTD ROPP CAPS
### A II 9/3/2013 RUBICON RESEARCH PRIVATE LTD COATED DEXTROMETHORPHAN POLISTIREX
### A II 9/24/2013 PFIZER HEALTHCARE INDIA PVT LTD ERTAPENEM SODIUM
### A II 8/14/2013 BAL PHARMA LTD BEPOTASTINE BESILATE
### I II 8/5/1996 STRATEGIC MANUFACTURING BASIC FIBROBLAST GROWTH FACTOR HUMAN,
WORLDWIDE INC RECOMBINANT, E. COLI.
### I II 7/15/2013 SUNBIO INC METHOXY POLYETHYLENE GLYCOL AMINE 2,000
Page 865
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 11/15/2013 UNIQUE CHEMICALS (A DIV OF J B CILNIDIPINE
CHEMICALS AND PHARMACEUTICALS
LTD)
### A II 10/14/2013 SUN PHARMACEUTICAL INDUSTRIES TESTOSTERONE USP
LTD
### A II 9/10/2013 MICRO LABS LTD RASAGILINE MESYLATE
### A III 8/16/2013 GREEN PACK FOILS PRIVATE LTD PET-FOIL-POLY LAMINATES
### A III 8/10/2013 GREEN PACK FOILS PRIVATE LTD COLD FORMING BLISTER (ALU-ALU) LAMINATE
### A II 11/1/2013 APOTEX PHARMACHEM INC BUDESONIDE USP
### A II 9/20/2013 GLENMARK PHARMACEUTICALS LTD LURASIDONE HYDROCHLORIDE
### A II 8/20/2013 ZHEJIANG CHARIOTEER VALACYCLOVIR HYDROCHLORIDE ANHYDROUS
PHARMACEUTICAL CO LTD FORM I
### A II 9/25/2013 MYLAN LABORATORIES LTD EFAVIRENZ USP (PROCESS-III)
### A II 9/24/2013 MYLAN LABORATORIES LTD EMTRICITABINE (PROCESS-II)
### A II 9/24/2013 MYLAN LABORATORIES LTD TENOFOVIR DISOPROXIL FUMARATE
(PROCESS-II)
### A II 8/31/2013 MSN LABORATORIES PRIVATE LTD DOCETAXEL TRIHYDRATE USP [ROUTE CODE -
"DO"]
### I II 9/6/2013 CTX LIFE SCIENCES PVT LTD LEVETIRACETAM
### A V 11/22/2013 MEDIMMUNE LLC FACILITIES AND EQUIPMENT INFORMATION FOR
THE MEDIMMUNE LLC, FREDERICK
MANUFACTURING CENTER
### A II 3/31/2014 CIPLA LTD BUDESONIDE USP
### A II 9/27/2013 CIPLA LTD LOPINAVIR USP
### A II 9/29/2013 CADILA HEALTHCARE LTD PITAVASTATIN MAGNESIUM
### A II 9/18/2013 IPCA LABORATORIES LTD MIDODRINE HYDROCHLORIDE USP
### A II 8/27/2013 ICROM SPA BEPOTASTINE BESILATE
### A II 8/26/2013 ASYMCHEM LABORATORIES TIANJIN CO TAMOXIFEN CITRATE
LTD
### I II 3/29/2014 FARMSON PHARMACEUTICAL GUJARAT ACETAMINOPHEN USP
PRIVATE LTD
### A II 5/7/2014 CIVENTICHEM LLC SODIUM NITROPRUSSIDE USP
### A II 9/30/2013 CIVENTICHEM LLC ISOPROTERENOL HYDROCHLORIDE USP
### A II 9/23/2013 BIOPHORE INDIA PHARMACEUTICALS ALOSETRON HYDROCHLORIDE
PVT LTD
### A III 12/13/2013 INDIAN OIL CORP LTD PROPEL PP2120MC
### A II 9/17/2013 RAKS PHARMA PVT LTD ESOMEPRAZOLE MAGNESIUM TRIHYDRATE,
USP
### A II 9/3/2013 NEULAND LABORATORIES LTD ETHACRYNIC ACID USP
### A II 9/13/2013 FORMOSA LABORATORIES INC MIFEPRISTONE
### A II 9/17/2013 FORMOSA LABORATORIES INC FONDAPARINUX SODIUM
### I III 8/15/2013 SSS PLASTICS PVT LTD BOTTLES AND CLOSURES
### A II 8/19/2013 CHONGQING FUAN PHARMACEUTICAL TIGECYCLINE
GROUP CO LTD
Page 866
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 8/28/2013 IMAX DIAGNOSTIC IMAGING HOLDING IODIXANOL
LTD
### A II 9/27/2013 ZHEJIANG HUAHAI PHARMACEUTICAL TADALAFIL USP
CO LTD
### I III 8/22/2013 AMPACET CORP 469837 BLUE SMC PP MB
### A II 9/29/2013 BIOPHORE INDIA PHARMACEUTICALS THIAMINE HYDROCHLORIDE
PVT LTD
### A II 9/20/2013 BIOPHORE INDIA PHARMACEUTICALS BENDAMUSTINE HYDROCHLORIDE
PVT LTD MONOHYDRATE
### A II 9/27/2013 BIOPHORE INDIA PHARMACEUTICALS ISOTRETINOIN
PVT LTD
### A II 9/28/2013 BIOPHORE INDIA PHARMACEUTICALS MELPHALAN HYDROCHLORIDE
PVT LTD
### A II 9/22/2013 YUNNAN HANDE BIO-TECH CO LTD PACLITAXEL DRUG SUBSTANCE, SEMI-
SYNTHESIZED FROM 10-DAB
### A II 9/23/2013 SHILPA MEDICARE LTD AZACITIDINE
### A II 9/26/2013 SHILPA MEDICARE LTD DECITABINE
### A II 9/26/2013 SHILPA MEDICARE LTD LETROZOLE USP
### A II 1/26/2015 NUSIL TECHNOLOGY LLC MED-342 SIMETHICONE GS
### I II 9/27/2013 CTX LIFE SCIENCES PVT LTD SEVELAMER HYDROCHLORIDE
### I II 9/27/2013 CTX LIFE SCIENCES PVT LTD COLESEVELAM HYDROCHLORIDE
### A II 9/25/2013 UNICHEM LABORATORIES LTD RANOLAZINE
### A III 9/6/2013 MITSUBISHI GAS CHEMICAL CO INC OA RESIN
### A II 9/23/2013 POLYCARBON INDUSTRIES INC DBA PCI PCI-104234 NON-STERILE BULK DRUG
SYNTHESIS SUBSTANCE
### A II 9/3/2013 OLON SPA BEZAFIBRATE
### I II 4/1/2003 VIVENTIA BIOTECH INC RECOMBINANT GELONIN (NOVOGELONIN)
### I II 5/22/1989 DOW CHEMICAL CO MONOCLONAL ANTIBODY CC49
### A II 9/30/2013 SPECGX LLC DEXTROMETHADONE HYDROCHLORIDE
### A II 9/19/2013 AUROBINDO PHARMA LTD CELECOXIB USP
### A II 9/19/2013 AUROBINDO PHARMA LTD ZOLMITRIPTAN
### A II 9/24/2013 ZHEJIANG HUAHAI PHARMACEUTICAL PALIPERIDONE USP
CO LTD
### A II 9/19/2013 ZHEJIANG HUAHAI PHARMACEUTICAL PIOGLITAZONE HYDROCHLORIDE USP
CO LTD
### A II 9/30/2013 ZHEJIANG HUAHAI PHARMACEUTICAL AMBRISENTAN
CO LTD
### A III 9/9/2013 AVERY DENNISON (KUNSHAN) CO LTD HP104 ADHESIVE
### I II 3/18/2003 MEDAREX MDX-015 (ANTI-IL15 HUMAN MONOCLONAL
ANTIBODY)
### A II 9/11/2013 GUANG'AN KINGDAY PHARMA AND AZTREONAM USP
CHEM CO LTD
### I II 1/9/2004 ALLERGAN INC BOTOX (R) (BOTULINUM TOXIN A) PURIFIED
NEUROTOXIN COMPLEX
Page 867
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 9/11/2013 YANCHENG YOUHUA PHARMACEUTICAL BACITRACIN USP
AND CHEMICAL TECHNOLOGY CO LTD
### A II 9/21/2013 IPCA LABORATORIES LTD ETODOLAC USP (ED7 PROCESS)
### A II 9/6/2013 CILAG AG REMIFENTANIL HCL DRUG SUBSTANCE
### A II 10/10/2013 TEVA PHARMACEUTICAL INDUSTRIES PALIPERIDONE
LTD
### I II 3/26/2003 BIOMEASURE INC DYSPORT(R) (BOTULINUM TOXIN A-
HEMAGGLUTININ COMPLEX)
### A II 9/30/2013 CADILA HEALTHCARE LTD RIVASTIGMINE USP
### I II 4/25/2000 COLORADO NEUROLOGICAL INSTITUTE BOTULINUM TOXIN B
### I II 3/21/2005 NUVELO INC PERIPHERAL ARTERIAL OCCLUSION
(ALFIMEPRASE)
### I II 10/3/2001 UNIVERSITY CHICAGO BOTOX(R) (BOTULINUM TOXIN A) PURIFIED
NEUROTOXIN COMPLEX
### I II 1/13/1999 UNIV TEXAS MEDICAL BRANCH BOTULINUM TOXIN
### I II 12/6/2001 MAYO CLINIC PEG INTERFERON ALFA 2B PLUS RIBAVIRIN
### A IV 9/9/2013 THE DOW CHEMICAL CO AFFINISOL™ HYDROXYPROPYL
METHYLCELLULOSE ACETATE SUCCINATE
### I II 6/30/1989 STRATEGIC MANUFACTURING FIBLAST(R) TRAFERMIN
WORLDWIDE INC
### A II 10/23/2013 TEVA PHARMACEUTICAL INDUSTRIES TIOTROPIUM BROMIDE
LTD
### I II 4/27/2014 TEVA PHARMACEUTICAL INDUSTRIES ATORVASTATIN CALCIUM
LTD
### I IV 9/18/2013 NOVOZYMES AS SODIUM HYALURONATE FROM BACILLUS
SUBTILIS (TOPICAL GRADE): HYASIS® 850T
### A II 9/27/2013 SANDOZ GMBH CEFIXIME
### A II 9/27/2013 CIPLA LTD PALONOSETRON HYDROCHLORIDE USP
### A III 8/29/2013 ROBIN INDUSTRIES INC EY-111214; USP CLASS VI APPROVED
CHLOROBUTYL COMPOUND FOR SYRINGE TIP
APPLICATIONS
### A III 9/4/2013 ROBIN INDUSTRIES INC I-5715; USP CLASS VI APPROVED
POLYISOPRENE COMPOUND FOR PLUNGER TIP
APPLICATIONS
### A II 9/26/2013 STEROID SPA TESTOSTERONE UNDECANOATE
### A II 9/21/2013 MACLEODS PHARMACEUTICALS LTD TROSPIUM CHLORIDE
### A II 9/29/2013 MACLEODS PHARMACEUTICALS LTD OSELTAMIVIR PHOSPHATE
### A II 9/13/2013 AMOLI ORGANICS PVT LTD LINEZOLID [FORM-1]
### A III 9/5/2013 ROBIN INDUSTRIES INC I-4318; USP CLASS VI APPROVED
POLYISOPRENE COMPOUND FOR PLUNGER TIP
APPLICATIONS
### A IV 9/12/2013 FREUND CORP NONPAREIL-105
### A III 9/11/2013 COIM USA INC NOVACOTE HS-8243
### A II 9/23/2013 MICRO LABS LTD TELMISARTAN USP
### A II 9/26/2013 MICRO LABS LTD OLMESARTAN MEDOXOMIL USP
Page 868
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 9/10/2013 BOREALIS AG BORMED SB815MO
### A V 10/18/2013 PFIZER INC MODULAR VIRAL CLEARANCE
### A III 9/13/2013 TAISEI KAKO CO LTD PLASTIC SYRINGES (VFP-ARD-5ML)
### A II 9/27/2013 SCINOPHARM TAIWAN LTD DECITABINE
### A II 9/9/2013 BIOSYN ARZNEIMITTEL GMBH SODIUM SELENITE PENTAHYDRATE
### A II 9/9/2013 BIOSYN ARZNEIMITTEL GMBH SELENIUM 5 MG TABLETS
### A II 10/22/2014 TAIZHOU TAIFA PHARMACEUTICALS CO MEDROXYPROGESTERONE ACETATE
LTD
### A II 9/23/2013 AREVIPHARMA GMBH BUPRENORPHINE
### A IV 12/17/2013 ASHLAND LLC AQUARIUS™ COATING SYSTEMS
### I III 9/10/2013 PRECIS PHARMA CONTAINERS PLASTIC CONTAINERS AND CLOSURES
### A II 9/30/2013 AUROBINDO PHARMA LTD SOLIFENACIN SUCCINATE
### A II 9/30/2013 AUROBINDO PHARMA LTD DARIFENACIN HYDROBROMIDE
### A III 9/13/2013 POLYONE CORP CC1012852460 (PE LITE BLUE 278C)
### A II 9/10/2013 OLON SPA ALITRETINOIN
### A II 9/13/2013 OLON USA INC ROTIGOTINE POLYMORPH II
### A V 9/17/2013 WEST PHARMACEUTICAL SERVICES INC NOVAPURE SYSTEM
### A II 11/26/2013 DDP SPECIALTY ELECTRONIC DOW CORNING™ Q7-2587 30% SIMETHICONE
MATERIALS US 9 LLC EMULSION USP
### A II 11/26/2013 DDP SPECIALTY ELECTRONIC DOW CORNING™ MEDICAL ANTIFOAM A
MATERIALS US 9 LLC COMPOUND
### I II 8/25/2013 WATERSTONE PHARMACEUTICALS L-Ala-pAF-OH HCl
HUBEI CO LTD
### I II 12/21/2013 ENALTEC LABS PRIVATE LTD ALCAFTADINE
### A II 9/16/2013 SAMYANG BIOPHARMACEUTICALS SEMISYNTHETIC PACLITAXEL
CORP
### A IV 11/26/2013 DDP SPECIALTY ELECTRONIC DOW CORNING™7-9245 30% SIMETHICONE
MATERIALS US 9 LLC EMULSION USP AND DOW CORNING™ MEDICAL
ANTIFOAM C EMULSION
### A II 2/12/2018 SCINOPHARM TAIWAN LTD ATAZANAVIR SULFATE
### A II 12/30/2013 SCINOPHARM TAIWAN LTD FONDAPARINUX SODIUM USP
### A II 12/30/2013 SCINOPHARM TAIWAN LTD GALANTAMINE
### A II 12/31/2014 SCINOPHARM TAIWAN LTD CLOFARABINE
### A II 12/28/2014 SCINOPHARM TAIWAN LTD PACLITAXEL USP
### A II 9/25/2013 CENTAUR PHARMACEUTICALS PVT LTD ZALEPLON USP
### A II 9/27/2013 MSN LABORATORIES PRIVATE LTD BORTEZOMIB [ROUTE CODE "BR"]
### A II 9/30/2013 MSN PHARMACHEM PRIVATE LTD LURASIDONE HYDROCHLORIDE [ROUTE CODE -
LN"]
### A II 9/30/2013 MSN LABORATORIES PRIVATE LTD PRASUGREL [ROUTE CODE - 'LP']
### I II 12/6/2013 HOUSTON CYCLOTRON PARTNERS LP 3'-DEOXY-3' -[18F] FLUOROTHYMIDINE ([18F]FLT)
INJECTION
### A II 7/25/2013 CAMBREX PROFARMACO MILANO SRL CYSTEAMINE BITARTRATE (RP)
### I III 9/17/2013 CYTECH COATINGS PVT LTD LAMINATION ADHESIVES
Page 869
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 12/19/2013 POLYPEPTIDE LABORATORIES SWEDEN VASOPRESSIN
AB
### A II 9/30/2013 IPCA LABORATORIES LTD CHLORTHALIDONE USP (CT6 PROCESS)
### A II 9/20/2013 SOLARA A PHARMA SCIENCES LTD ETOMIDATE
### A III 9/17/2013 BORMIOLI PHARMA SPA DROPPER TSD LDPE
### A III 9/18/2013 NEW AGE INDUSTRIES INC ADVANTAPURE SILICONE APST TUBING NI202
### A II 10/21/2013 VASUDHA PHARMA CHEM LTD PIMOZIDE USP
### A II 12/5/2013 ALP PHARM BEIJING CO LTD LURASIDONE HYDROCHLORIDE
### A II 11/27/2013 CHUNGHWA CHEMICAL SYNTHESIS AND CASPOFUNGIN ACETATE
BIOTECH CO LTD
### A II 9/24/2013 MOEHS IBERICA SL PRILOCAINE HYDROCHLORIDE
### A III 9/23/2013 BOREALIS AG BORMED LE6600-PH
### I IV 9/25/2013 FONA INTERNATIONAL INC PRODUCT # 815.016 N-C BUBBLEGUM FLAVOR,
NAT & ART
### I II 9/29/2013 ALP PHARM BEIJING CO LTD CLOPIDOGREL BISULFATE FORM II
### I II 10/30/2013 SINOPEP JIANGSU INC DRONEDARONE HYDROCHLORIDE
### A II 11/28/2013 SUN PHARMACEUTICAL INDUSTRIES CINACALCET HYDROCHLORIDE
LTD
### A II 3/20/2014 TEVA PHARMACEUTICAL INDUSTRIES FOSAMPRENAVIR CALCIUM
LTD
### A III 9/2/2013 SCORPION CONTAINERS PRIVATE LTD HDPE BOTTLE SET (BOTTLE, CAP, MEASURING
CUP)
### A III 9/25/2013 3M DRUG DELIVERY SYSTEMS 3M COTRANT 9695 TAN SPUNLACE NONWOVEN
TAPE
### A II 11/5/2013 JIANGSU GRAND XIANLE MEGESTROL ACETATE
PHARMACEUTICAL CO LTD
### A II 9/25/2013 VIWIT PHARMACEUTICAL CO LTD (2R, 3S)-2[(1R)-1-[3,5-
BIS(TRIFLUOROMETHYL)PHENYL]ETHOXY]-3-(4-
FLUOROPHENYL)-MORPHOLINE, 4-
METHYLBENZENESULFONATE
### A II 9/26/2013 KREATIVE ORGANICS PRIVATE LTD GLIPIZIDE USP
### A II 9/26/2013 EUTICALS INC SODIUM OXYBATE
### A II 2/26/2014 YUNG SHIN PHARMACEUTICAL ENTECAVIR MONOHYDRATE
INDUSTRIAL CO LTD
### A II 10/1/2013 HETERO LABS LTD LAPATINIB DITOSYLATE MONOHYDRATE
### A II 10/1/2013 NOF CORP ALPHA-SUCCINIMIDYLOXYSUCCINYL-OMEGA-
METHOXY, POLYOXYETHYLENE MW:4,500
### A III 9/23/2013 STERI-PLAS PTY LTD 150ML TABLET BOTTLE
### I II 9/30/2013 ALCHEM INTERNATIONAL LTD DIGOXIN USP
### A III 9/27/2013 TEKNOR COLOR CO 71,094HCP ORANGE 50:1
### A II 8/2/2013 PHAEX POLYMERS PRIVATE LTD CHOLESTYRAMINE RESIN USP AS IN
### A II 9/30/2013 SIGMA ALDRICH IRELAND LTD SODIUM BENZOATE
### A II 10/24/2013 BHARAT PHARMA (A UNIT OF BHARAT DILUTED NITROGLYCERIN USP
EXPLOSIVES LTD)
### A II 1/10/2014 GLENMARK PHARMACEUTICALS LTD APREPITANT USP (BO74 PROCESS)
Page 870
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
27611 I II 9/30/2013 HIKAL LTD DONEPEZIL HYDROCHLORIDE API
### A II 11/30/2013 MSN LABORATORIES PRIVATE LTD ROFLUMILAST [ROUTE CODE - RO"]
### A III 10/4/2013 MINNESOTA RUBBER AND PLASTICS SILICONES FOR SEALING APPLICATIONS IN
MEDICAL DEVICES
### A II 10/11/2013 MSN LABORATORIES PRIVATE LTD POSACONAZOLE AMORPHOUS [ROUTE CODE
PKA]
### A II 10/21/2013 ZHEJIANG HISUN PHARMACEUTICAL CO PRAVASTATIN SODIUM USP (PROCESS II)
LTD
### A II 11/19/2013 EMCURE PHARMACEUTICALS LTD EPL 001
### A II 10/25/2013 EMCURE PHARMACEUTICALS LTD GEMCITABINE HYDROCHLORIDE USP
(PROCESS II)
### A II 12/27/2013 EMCURE PHARMACEUTICALS LTD OLSALAZINE SODIUM (PROCESS II)
### A IV 9/26/2013 SEPPIC SA SEPITRAP 80
### A II 10/1/2013 ZAKLADY FARMACEUTYCZNE DABIGATRAN ETEXILATE METHANESULFONATE
POLPHARMA SA
### A III 9/17/2013 BORMIOLI PHARMA SPA BOTTLE LDPE 3-5 ML
### A II 9/27/2013 IRVINE SCIENTIFIC SALES CO DSP06B POWDER
### A II 10/18/2013 INDUSTRIALE CHIMICA SRL DALFAMPRIDINE
### A II 9/23/2013 MURLI KRISHNA PHARMA PVT LTD ORLISTAT PELLETS 50.0% W/W
### A II 10/8/2013 IRVINE SCIENTIFIC SALES CO INC PRIME-XV™ AFSC EXPANSION MEDIUM
### A II 9/23/2013 MURLI KRISHNA PHARMA PVT LTD TACROLIMUS PELLETS 5.0% W/W
### A II 10/8/2013 KREATIVE ORGANICS PRIVATE LTD SODIUM PICOSULFATE USP
### I II 12/27/2013 3D IMAGING DRUG DESIGN AND [I-124]CLR1404 INJECTION
DEVELOPMENT LLC
### A III 10/8/2013 CLARIANT PLASTICS AND COATINGS MATERIAL FOR PLASTIC PACKAGING
USA INC
### A II 7/19/2013 HUNAN YUXIN PHARMACEUTICAL CO 16ALPHA-HYDROXY PREDNISOLONE
LTD
### A II 10/9/2013 ASYMCHEM LIFE SCIENCE TIANJIN CO ATAZANAVIR SULFATE
LTD
### A II 10/28/2013 HETERO DRUGS LTD ROSUVASTATIN CALCIUM (AMORPHOUS)
### A II 11/12/2013 INDOCO REMEDIES LTD RASAGILINE MESYLATE
### A II 3/24/2015 TIANJIN TIANYAO PHARMACEUTICALS CELECOXIB USP
CO LTD
### A II 12/4/2013 APOTEX PHARMACHEM INDIA PVT LTD TOLVAPTAN
### A II 11/1/2013 ALKEM LABORATORIES LTD DALFAMPRIDINE USP
### A III 10/8/2013 TOPPAN PRINTING CO LTD A PET/EVA BACKING FILM FOR TRANSDERMAL
DRUG DELIVERY PATCHES
### A II 10/31/2013 TORRENT PHARMACEUTICALS LTD ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP
### A II 11/30/2013 MSN LABORATORIES PRIVATE LTD TOFACITINIB CITRATE [ROUTE CODE - TT"]
### A II 12/6/2013 PAR PHARMACEUTICAL INC COLCHICINE USP
### A II 12/12/2013 CORDEN PHARMA COLORADO INC GLATIRAMER ACETATE
### A II 12/19/2013 ZHEJIANG HISUN PHARMACEUTICAL CO IRINOTECAN HYDROCHLORIDE USP
LTD
### A II 12/31/2013 HISUN PHARMACEUTICAL HANGZHOU SIROLIMUS
CO LTD
### A II 1/31/2014 CADILA PHARMACEUTICALS LTD PHTHALOYL AMLODIPINE
### A II 12/27/2013 MYLAN LABORATORIES LTD ELVITEGRAVIR
### A II 12/24/2013 MYLAN LABORATORIES LTD RALTEGRAVIR POTASSIUM
### A II 12/20/2013 MYLAN LABORATORIES LTD OCTREOTIDE ACETATE USP
### A II 12/17/2013 MYLAN LABORATORIES LTD FINGOLIMOD HYDROCHLORIDE USP
### A II 12/6/2013 VASUDHA PHARMA CHEM LTD LOPERAMIDE HYDROCHLORIDE USP
### A II 2/6/2014 ASH STEVENS INC 8-CHLOROADENOSINE
### A II 11/25/2013 JOYANG LABORATORIES BACITRACIN ZINC
Page 874
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 11/13/2013 SHOUGUANG FUKANG OMEPRAZOLE MAGNESIUM
PHARMACEUTICAL CO LTD
### A III 9/20/2013 DANYANG XIANGHE PHARMACEUTICAL INJECTION VIALS MADE OF NEUTRAL
PACKAGING CO LTD BOROSILICATE GLASS TUBING
### A III 11/11/2013 RAJAT VINYLS PRIVATE LTD RIGID PVC FILM FOR PHARMACEUTICAL AND
FOOD PACKAGING APPLICATION
### I II 11/15/2013 ICEUTICA INC SOLUMATRIXT ABIRATERONE ACETATE DRUG
PRODUCT INTERMEDIATE
### A IV 11/12/2013 LIPOID GMBH LIPOID PURIFIED OLEIC ACID (PH.EUR.)
### A V 11/18/2013 ZHUHAI UNITED LABORATORIES CO LTD STERILIZATION PROCESS VALIDATION
INFORMATION FOR CARBOPENEM STERILE
PRODUCTS
### I IV 8/2/2013 PJ HEALTHCARE PNEU 112 GRANULES
### A II 10/5/2013 JIANGSU HUANXIN HIGH-TECH CHLOROXYLENOL
MATERIALS CO LTD
### A III 11/11/2013 PACKAGING INDIA PVT LTD PLAIN OR PRINTED POLYETHLENE
TETRAPHTHALATE/ ALUMINIUM FOIL/
POLYETHYLENE LAMINATES
### A II 12/30/2013 HISUN PHARMACEUTICAL NANTONG CO CELECOXIB USP
LTD
### A II 11/12/2013 SCI PHARMTECH INC (S)-3-(METHYLAMINO)-1-(2-THIENYL) PROPAN-1-
OL [(S)-MMAA]
### A II 12/2/2013 ZHEJIANG HISUN PHARMACEUTICAL CO PIOGLITAZONE HYDROCHLORIDE USP
LTD
### A III 11/15/2013 KUNSHAN WISEPAC DESICCANT CO LTD WISEMINI PACKED DESICCANT FOR
PHARMACEUTICAL INDUSTRY WITH MOLECULE
SIEVE AS ABSORBENT, TYVEK 1059B AS
PACKAGING MATERIAL
### I IV 10/25/2013 PJ HEALTHCARE INNOKOAT
### A II 11/18/2013 ASYMCHEM LABORATORIES TIANJIN CO ANASTROZOLE
LTD
### A III 3/15/2013 CHROMA CORP PC90261A CLARIFYING CONCENTRATE
### A II 3/28/2014 AVANTOR PERFORMANCE MATERIALS SODIUM ACETATE TRIHYDRATE
LLC
### A II 4/25/2014 AVANTOR PERFORMANCE MATERIALS POTASSIUM PHOSPHATE MONOBASIC
INC
### A II 4/25/2014 AVANTOR PERFORMANCE MATERIALS SODIUM PHOSPHATE, MONOBASIC,
INC MONOHYDRATE
### A II 3/28/2014 AVANTOR PERFORMANCE MATERIALS POTASSIUM PHOSPHATE DIBASIC
INC
### A II 11/20/2013 SOLARA A PHARMA SCIENCES LTD PANTOPRAZOLE SODIUM, USP
### I IV 11/20/2013 FONA INTERNATIONAL INC 865.0037U LIME EXTRACT, NAT
### I IV 11/20/2013 FONA INTERNATIONAL INC 825.0597U N-C CHERRY FLAVOR, ART
### A II 11/21/2013 AMBIOPHARM INC OCTREOTIDE, NON-STERILE, BULK DRUG
SUBSTANCE
Page 875
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 11/7/2013 JIANGSU ZHONGJIN MATAI MEDICINAL PA/AL/PVC COLD FORMING COMPOSITE SHEET
PACKAGING CO LTD FOR PACKAGING OF SOLID DOSAGE FORMS
### A II 12/10/2013 NISSAN CHEMICAL INDUSTRIES LTD PITAVASTATIN CALCIUM (ASYMMETRIC
SYNTHESIS METHOD)
### A II 12/13/2013 ZHEJIANG HISUN PHARMACEUTICAL CO OXALIPLATIN USP
LTD
### A II 12/16/2013 HUBEI GEDIAN HUMANWELL DUTASTERIDE ACID
PHARMACEUTICAL CO LTD
### A II 11/20/2013 WANBURY LTD QUETIAPINE FUMARATE
### A II 11/21/2013 INALCO SRL LACTITOL MONOHYDRATE
### A IV 11/21/2014 SE TYLOSE GMBH AND CO KG HYPROMELLOSE USP (TYLOPUR®)
### A II 12/26/2013 CADILA HEALTHCARE LTD ENTECAVIR USP
### A III 12/18/2013 KAKEN PHARMACEUTICAL CO LTD PLASTIC CONTAINER FOR TOPICAL SOLUTION
### A II 12/26/2013 ZHEJIANG HISUN PHARMACEUTICAL CO ROSUVASTATIN CALCIUM
LTD
### A V 12/11/2013 EVONIK NUTRITION AND CARE GMBH EUDRAGIT® E
### A II 1/10/2014 EMCURE PHARMACEUTICALS LTD DOCETAXEL TRIHYDRATE USP (PROCESS II)
### A II 11/26/2013 IRVINE SCIENTIFIC SALES CO INC PRIME-XV® MSC EXPANSION SFM
### I II 12/13/2013 NOVOZYMES AS SODIUM HYALURONATE FROM BACILLUS
SUBTILIS (PARENTERAL GRADE): HYASIS(R)
850P
### A II 12/11/2013 HETERO LABS LTD DUTASTERIDE
### A V 11/26/2013 WEST PHARMACEUTICAL SERVICES INC STEAM STERILIZATION PROCESS
### A II 11/27/2013 ZHEJIANG JINHUA CONBA BIO PHARM AMIKACIN SULFATE USP
CO LTD
### A II 9/6/2013 SHANGHAI DESANO CHEMICAL ROSUVASTATIN CALCIUM
PHARMACEUTICAL CO LTD
### A II 12/26/2013 S AND B PHARMA INC DBA NORAC PEN-10101 DRUG SUBSTANCE
PHARMA
### A II 3/28/2014 ALP PHARM BEIJING CO LTD ROFLUMILAST
### I II 12/27/2013 ALEMBIC PHARMACEUTICALS LTD VALSARTAN USP (PROCESS III)
### A II 12/31/2013 ALEMBIC PHARMACEUTICALS LTD DABIGATRAN ETEXILATE MESYLATE
### A III 11/26/2013 PLASTIQUES VENTHENAT EXTRUSION ACRYTER FILM
### A II 11/25/2013 SYMBIOTEC PHARMALAB PRIVATE LTD METHYLPREDNISOLONE, USP (MICRONIZED)
### A II 12/18/2013 SANDOZ PRIVATE LTD APREPITANT
### I II 1/8/2014 SANDOZ PRIVATE LTD MEROPENEM TRIHYDRATE, STERILE
### A II 12/10/2013 MSN LABORATORIES PRIVATE LTD PALIPERIDONE PALMITATE [ROUTE CODE - PM"]
Page 876
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 11/20/2013 ZHEJIANG JIUZHOU PHARMACEUTICAL SORAFENIB TOSYLATE (VERSION NO.: 1)
CO LTD
### A II 11/29/2013 SHANGHAI ACANA PHARMATECH CO FONDAPARINUX INTERMEDIATE N3
LTD
### A II 12/21/2013 AUROBINDO PHARMA LTD ISOSULFAN BLUE
### A IV 1/28/2014 EVONIK NUTRITION AND CARE GMBH EUDRAGIT® L/S
### A II 12/30/2013 EMCURE PHARMACEUTICALS LTD CLOFARABINE
### I III 11/18/2013 SAMET PLAST MASTER BATCHES
### A III 12/3/2013 BOREALIS AG BORMED HG820MO AND BORMED HG820MO-11
### A II 12/23/2013 MICRO LABS LTD BROENAC SODIUM SESQUIHYDRATE
### A II 12/8/2013 ZHEJIANG GUOBANG PHARMACEUTICAL AZAERYTHROMYCIN
CO LTD
### A II 12/9/2013 RN LABORATORIES PVT LTD CHLORHEXIDINE BASE
### A III 2/23/2014 INDIAN OIL CORP LTD PROPEL HDPE 012DB54
### A II 5/23/2014 GLENMARK PHARMACEUTICALS LTD TELMISARTAN USP (D297 PROCESS)
### A II 12/28/2013 BIOPHORE INDIA PHARMACEUTICALS PHYTONADIONE ROUTE-B
PVT LTD
### A II 1/8/2014 RELIABLE BIOPHARMACEUTICAL LLC CHLORAMPHENICOL HEMISUCCINATE
### A II 12/31/2013 MSN LABORATORIES PRIVATE LTD RIVAROXABAN [ROUTE CODE - 'RR']
### A II 12/28/2013 MSN LABORATORIES PRIVATE LTD TOLVAPTAN (AMORPHOUS) [ROUTE CODE TNA]
### A II 12/6/2013 POLYMED THERAPEUTICS INC PEMETREXED DISODIUM 2.5 HYDRATE DRUG
SUBSTANCE
### A II 12/16/2013 GLOCHEM INDUSTRIES LTD AMLODIPINE BESYLATE (PROCESS 1)
27811 A II 12/23/2013 TRIFARMA SPA FLUPHENAZINE DECANOATE
### A II 12/27/2013 ALCHYMARS ICM SM PRIVATE LTD SODIUM NITROPRUSSIDE USP
### A II 3/14/2014 JUBILANT GENERICS LTD ROSUVASTATIN CALCIUM AMORPHOUS
### A III 12/28/2013 ALPHAMED BOTTLES INC HDPE BOTTLES
### A III 12/11/2013 TOSOH CORP PETROTHENE 170K PACKAGING MATERIAL
### A II 2/25/2014 JOHNSON MATTHEY PHARMA SERVICES 4245.C (MILLED) [DOFETILIDE]
### I III 12/10/2013 POLYONE CORP EM10031235XX (PELL-80AE TRANS RO BACONC)
Page 884
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 2/28/2014 HENAN LIHUA PHARMACEUTICAL CO HYDROCORTISONE USP
LTD
### A III 2/19/2014 BORMIOLI PHARMA SPA BOTTLE LDPE 15 ML
### A IV 3/5/2014 FONA INTERNATIONAL INC 856.0232U GRAPE FLAVOR, NAT & ART
### I II 2/25/2014 JINGMEN SHUAIBANG CHEMICAL TENOFOVIR (DRUG SUBSTANCE
SCIENCE AND TECHNOLOGY CO LTD INTERMEDIATE)
### A II 3/20/2014 MSN LABORATORIES PRIVATE LTD MIRABEGRON [ROUTE CODE "MG"]
### A II 3/22/2014 MSN PHARMACHEM PRIVATE LTD VILAZODONE HYDROCHLORIDE [ROUTE CODE
"VN"]
### A II 3/24/2014 MSN ORGANICS PRIVATE LTD RIVASTIGMINE TARTRATE USP [ROUTE CODE
"RM"]
### A IV 3/5/2014 HUNAN ER KANG PHARMACEUTICAL CO STARCHGEL (MODIFIED STARCH)
LTD
### A II 3/6/2014 TEVA PHARMACEUTICAL INDUSTRIES BUPRENORPHINE
LTD
### I II 4/21/2014 APOTEX PHARMACHEM INDIA PVT LTD LURASIDONE HYDROCHLORIDE
### I II 4/10/2014 HOUSTON CYCLOTRON PARTNERS LP FLUOROLEVODOPA F 18 INJECTION
### A II 3/18/2014 EMCURE PHARMACEUTICALS LTD DEXMEDETOMIDINE HYDROCHLORIDE USP
### I II 1/29/2015 JIANGSU HIBROAD BIO- VANCOMYCIN HYDROCHLORIDE
PHARMACEUTICAL CO LTD
### A IV 3/5/2014 CI FARMACAPSULAS SA ACID RESISTANT CAPSULES (AR CAPS®)
### A IV 2/26/2014 GM CHEMIE PVT LTD HYPROMELLOSE PHTHALATE USP
### I IV 3/4/2014 KERRY INGREDIENTS AND FLAVOURS 30623270 NAT FL MODULATOR (MASKING) FMT r
DBA MASTERTASTE INC PWD
### I IV 3/4/2014 KERRY INGREDIENTS AND FLAVOURS 30623266 NAT FL MODULATOR (MASKING) FMTr
DBA MASTERTASTE INC PWD
### A II 5/2/2014 CIPLA LTD DARIFENACIN HYDROBROMIDE
### A II 3/25/2014 MSN LABORATORIES PRIVATE LTD DAPAGLIFLOZIN PROPANEDIOL [ROUTE CODE -
"DQ"]
### A II 3/31/2014 CIPLA LTD MONTELUKAST SODIUM USP
### A II 9/29/2015 USV PRIVATE LTD PALONOSETRON HYDROCHLORIDE
### A III 2/19/2014 QUALITY PLASTICS LLC POLYETHYLENE BOTTLES
### A II 3/10/2014 SRIKEM LABORATORIES PVT LTD PERMETHRIN
### A II 4/1/2014 ZHEJIANG HUAHAI PHARMACEUTICAL PAROXETINE MESYLATE
CO LTD
### A II 3/27/2014 MSN LABORATORIES PRIVATE LTD AZILSARTAN KAMEDOXOMIL [ROUTE CODE "AK"]
### A II 3/26/2014 MSN LABORATORIES PRIVATE LTD ACLIDINIUM BROMIDE [ROUTE CODE "AU"]
### A II 3/26/2014 MSN LABORATORIES PRIVATE LTD PEMETREXED DISODIUM HEPTAHYDRATE
[ROUTE CODE "PT"]
### A II 3/27/2014 MSN LABORATORIES PRIVATE LTD AVANAFIL [ROUTE CODE "AV"]
### A II 3/28/2014 MSN LABORATORIES PRIVATE LTD RIFAXIMIN [ROUTE CODE "RX"]
### A II 3/28/2014 MSN LABORATORIES PRIVATE LTD RIFAXIMIN [ROUTE CODE "RFa"]
### A II 3/28/2014 MSN PHARMACHEM PRIVATE LTD LINAGLIPTIN [ROUTE CODE "LG"]
Page 885
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 3/28/2014 MSN LABORATORIES PRIVATE LTD PEMETREXED DISODIUM HEMIPENTAHYDRATE
[ROUTE CODE "PN"]
### A II 4/5/2014 MSN LABORATORIES PRIVATE LTD AZACITIDINE [ROUTE CODE "AJ"]
### A II 4/1/2014 TEVA PHARMACEUTICAL INDUSTRIES CABAZITAXEL
LTD
### A II 7/15/2014 TEVA PHARMACEUTICAL INDUSTRIES NILOTINIB HYDROCHLORIDE
LTD
### A IV 3/12/2014 HUNAN ER KANG PHARMACEUTICAL CO HYDROXYPROPYL STARCH VACANT CAPSULE
LTD
### A III 3/11/2014 BINNY WADS PVT LTD EPE (EXPANDED POLYETHYLENE)
LINERS/SHEET
### I II 3/20/2014 TYCHE INDUSTRIES LTD NEVIRAPINE
### A II 3/13/2014 FINE CHEMICALS CORP PTY LTD REMIFENTANIL HYDROCHLORIDE
### A II 3/12/2014 POLYMED THERAPEUTICS INC AZACITIDINE USP
### A II 3/24/2014 MICRO LABS LTD LUMEFANTRINE USP
### A II 1/15/2014 JIAOZUO JOINCARE D-7ACA
BIOTECHNOLOGICAL CO LTD
28110 A II 2/20/2014 PHARMARESOURCES (KAIYUAN) CO LTD TICAGRELOR INTERMEDIATE, 2-((3AR, 4S, 6R,
6AS)-6-AMINO-2, 2-DIMETHYLTETRAHYDRO-3AH-
CYCLOPENTA [D] [1,3] DIOXOL-4-YLOXY)
ETHANOL L-TARTARIC ACID (1:1) (CAS:376608-65-
0)
28111 A II 2/20/2014 PHARMARESOURCES (KAIYUAN) CO LTD TICAGRELOR INTERMEDIATE, 4, 6-DICHLORO-2-
(PROPYLTHIO) PYRIMIDINE-5-AMINE (CAS:
145783-15-9)
28112 A II 2/20/2014 PHARMARESOURCES (KAIYUAN) CO LTD TICAGRELOR INTERMEDIATE, (1R, 2S) -2- (3,4-
DIFLUOROPHENYL) CYCLOPROPANAMINE (R)-2-
HYDROXY-2-PHENYLACETATE (1:1) (CAS:
376608-71-8)
28113 A III 3/14/2014 POLYONE CORP T270.0
28114 A III 3/14/2014 POLYONE CORP T270.5
28115 A III 3/14/2014 POLYONE CORP T623.8
28116 A III 3/12/2014 COLORS FOR PLASTICS INC THERMOPLASTIC RESIN B25026 BLUE 279C AND
G27947 COOL GREY 6C COLORANT
MASTERBATCHES
28117 A II 2/9/2014 WEINAN HIGH TECH NEW ELECTRONIC P-[[(1S)-2-[4-(BENZOYLAMINO)-2-OXO-1(2H)-
CHEMICAL CO LTD PYRIMIDINYL]-1-
(HYDROXYMETHYL)ETHOXY]METHYL]PHOSPHO
NIC ACID DIETHYL ESTER
28118 A II 4/27/2014 TEVA PHARMACEUTICAL INDUSTRIES DABIGATRAN ETEXILATE MESYLATE
LTD
28119 A II 4/16/2014 MEDICHEM SA MED-300179/E (INTERMEDIATE)
### A II 4/4/2014 CHEMISCHE FABRIK BERG GMBH METHENAMINE HIPPURATE
### A II 3/31/2014 DR REDDYS LABORATORIES LTD RIVAROXABAN
### A II 4/16/2014 CADILA PHARMACEUTICALS LTD ATORVASTATIN CALCIUM USP FORM-I
Page 886
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 3/18/2014 SOLARA A PHARMA SCIENCES LTD PREGABALIN USP
### A II 3/17/2014 SYMBIOTEC PHARMALAB PRIVATE LTD DESOGESTREL EP/BP, MICRONIZED
### A II 3/17/2014 STERLING SPA NOMEGESTROL ACETATE CODE 204622
### A II 4/18/2014 MYLAN LABORATORIES LTD LURASIDONE HYDROCHLORIDE
### A II 3/31/2014 DR REDDYS LABORATORIES LTD ESOMEPRAZOLE MAGNESIUM [AMORPHOUS]
[PRODUCT CODE: ADR]
### A II 3/31/2014 RAKS PHARMA PVT LTD RITONAVIR, USP (FORM-I)
### A II 4/1/2014 CIPLA LTD ATAZANAVIR SULPHATE (METHANOL ROUTE)
### A IV 3/18/2014 HENKEL CORP GELVA GMS 3087 PRESSURE SENSITIVE
ADHESIVE
### I IV 3/20/2014 FONA INTERNATIONAL INC 807.174 MIXED BERRY FLAVOR, NAT WONF
### A II 3/24/2014 CEDARBURG PHARMACEUTICALS INC BULK ETHANOLAMINE OLEATE API IN SOLUTION
### A II 4/17/2014 BEIJING HUIKANG BOYUAN CHEMICAL VILDAGLIPTIN
TECH CO LTD
### A II 4/2/2014 INDOCO REMEDIES LTD BRINZOLAMIDE USP
### I II 3/31/2014 DR REDDYS LABORATORIES LTD ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
[PRODUCT CODE: ERM]
### A IV 3/13/2014 TAKASAGO INTERNATIONAL CORP PUMA WHIZZLE - FLAVOUR TEG - 10353526
### A II 3/20/2014 SYMBIOTEC PHARMALAB PRIVATE LTD BECLOMETHASONE DIPROPIONATE USP
(MICRONIZED & NON-MICRONIZED)
### I IV 3/20/2014 PHARMA 73 SA HPE 1 - CHITIN GLUCAN COMPLEX
### A II 4/18/2014 CADILA PHARMACEUTICALS LTD CARVEDILOL USP
### A II 3/31/2014 KD PHARMA BEXBACH GMBH EPA 550/DHA 200 FFA
### A V 4/29/2014 PHARMALUCENCE INC STERILE PROCESSING FACILITY
### A II 4/23/2014 TAI HENG INDUSTRY CO LTD FINGOLIMOD HYDROCHLORIDE
### A III 3/24/2014 MINNESOTA RUBBER AND PLASTICS 914M, A FLUOROELASTOMER RUBBER FOR
SEALING AND OTHER MEDICAL-RELATED
APPLICATIONS IN MEDICAL DEVICES
### A II 3/29/2014 PIRAMAL ENTERPRISES LTD PERINDOPRIL ERBUMINE
### A III 3/17/2014 AMPACET CORP 10053-K AMSTAT 53
### I II 4/9/2014 TYCHE INDUSTRIES LTD TENOFOVIR DISOPROXIL FUMARATE
### A III 3/17/2014 AMPACET CORP 4500166-N PINK PP MB
### A II 4/27/2014 TEVA PHARMACEUTICAL INDUSTRIES FINGOLIMOD HYDROCHLORIDE
LTD
### A II 4/23/2014 MACLEODS PHARMACEUTICALS LTD FEBUXOSTAT
### I IV 3/26/2014 FONA INTERNATIONAL INC 822.0174U CARAMEL MAILLARD FLAVOR, NAT
WONF
### I II 3/27/2014 REVIMMUNE INC CYT107
### A III 3/28/2014 IPS SRL COLD FORMABLE FOIL LAMINATE
### A III 4/4/2014 INDIAN OIL CORP LTD PROPEL HDPE 180M50
### A IV 3/24/2014 ACG ASSOCIATED CAPSULES PVT LTD EXCIPIENT CELLULOSE CAPSULE SHELLS
### A II 3/27/2014 SOLARA A PHARMA SCIENCES LTD CINACALCET HYDROCHLORIDE
### A II 6/12/2014 MERCK KGAA SAFINAMIDE METHANESULFONATE
### A II 5/15/2014 MAPRIMED SA FLECAINIDE ACETATE PROCESS III (CODE
50970)
Page 887
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 4/21/2014 HETERO LABS LTD CABAZITAXEL
### A II 4/4/2014 CHEMCON GMBH SODIUM NITROPRUSSIDE DIHYDRATE
### A II 12/26/2013 WAVELENGTH ENTERPRISES LTD TIOTROPIUM BROMIDE MONOHYDRATE
### A II 5/30/2014 SHILPA MEDICARE LTD FINGOLIMOD HYDROCHLORIDE
### I II 3/27/2014 PERRIGO API LTD ESOMEPRAZOLE MAGNESIUM DIHYDRATE
### A II 4/22/2014 TORRENT PHARMACEUTICALS LTD LURASIDONE HYDROCHLORIDE
### A II 4/23/2014 HEC PHARM CO LTD FINGOLIMOD HYDROCHLORIDE NON-STERILE
BULK DRUG SUBSTANCE
### A III 3/27/2014 AMPACET CORP 113099 BLUE WHITE SLIP PE MB
### I III 3/18/2014 TEKNOR COLOR CO 16,386HCPP MAGENTA 227C 50:1
### A II 3/31/2014 IRVINE SCIENTIFIC SALES CO INC RPMI MEDIUM 1640 - LIQUID
### A II 3/31/2014 IRVINE SCIENTIFIC SALES CO PBS 1X DULBECCO'S PHOSPHATE BUFFERED
SALINE SOLUTION WITHOUT CALCIUM AND
MAGNESIUM SALTS - LIQUID
### A II 3/28/2014 CHEMPORT INC E550D200FFA (OMEGA-3-POLYUNSATURATED
FREE FATTY ACIDS)
### A II 4/1/2014 SYMED LABS LTD ESZOPICLONE
### A III 4/11/2014 ALPHAMED BOTTLES INC CLOSURES
### A II 4/14/2014 LUPIN LTD EZETIMIBE USP (PROCESS-B)
### A III 4/1/2014 POLYONE CORP CC00012728XX
### A II 5/15/2014 PAR PHARMACEUTICAL INC FERRIC CITRATE
### A II 4/18/2014 PAR PHARMACEUTICAL INC TIZANIDINE HYDROCHLORIDE, USP
### A II 8/5/2014 HETERO DRUGS LTD DABIGATRAN ETEXILATE MESYLATE
### A II 4/28/2014 TEVA PHARMACEUTICAL INDUSTRIES LURASIDONE HYDROCHLORIDE
LTD
### A III 4/4/2014 ARTE CORP DUAL CHAMBER PREFILLABLE SYRINGE WITH
CAP (WITHOUT NEEDLE)
### A II 4/2/2014 KATAYAMA SEIYAKUSYO CO LTD LULICONAZOLE
### A III 4/3/2014 AMPACET CORP 151249 RED HDPE MB
### A II 5/18/2014 TEVA PHARMACEUTICAL INDUSTRIES IMATINIB MESYLATE FORM ALPHA
LTD
### A III 3/15/2014 INNOVOPAK INC POLY-PROPYLENE DOSAGE CUP
### A IV 4/2/2014 TAKASAGO INTERNATIONAL CORP TOOTHPASTE FLAVOR F-91250
### A III 4/7/2014 POLYLAB INTERNATIONAL PLASTIC CONTAINERS FOR PHARMACEUTICAL
PACKAGING
### A II 4/24/2014 BEIJING HUIKANG BOYUAN CHEMICAL ALOGLIPTIN BENZOATE
TECH CO LTD
### A IV 4/7/2014 ANTARES HEALTH PRODUCTS INC ANTARES VITAMIN E TPGS, NF GRADE
### A IV 4/8/2014 FONA INTERNATIONAL INC 815.0084U BUBBLE GUM FLAVOR ART
### A II 6/26/2014 BAYER AG AZELAIC ACID (A)
### A II 5/15/2014 CORDEN PHARMA LATINA SPA CEFEPIME/L-ARGININE STERILE BLEND
### A II 6/28/2016 SIGNA SA DE CV IMATINIB MESYLATE
### A II 6/16/2014 APICORE US LLC PHENTOLAMINE MESYLATE, USP
### A II 6/15/2014 APICORE US LLC TETRABENAZINE
### A III 3/31/2014 BASELL POLIOLEFINE ITALIA SRL PURELL POLYPROPYLENE PRODUCTS
Page 888
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 4/10/2014 NOF CORP [A-METHOXY-W-AMINOPROPYL, POLY
(OXYETHYLENE)]-BLOCK-POLY (L-SODIUM
GLUTAMATE)
### A IV 3/27/2014 ANHUI SUNHERE PHARMACEUTICAL SODIUM STARCH GLYCOLATE A
EXCIPIENTS CO LTD
### A II 4/10/2014 VIWIT PHARMACEUTICAL CO LTD RIVAROXABAN (DRUG SUBSTANCE, NON-
STERILE)
### A II 4/18/2014 ALP PHARM BEIJING CO LTD DRONEDARONE HYDROCHLORIDE
### A III 4/10/2014 COLORTECH INC 10868-18 SLIP/ANTIBLOCK POLYETHYLENE
CONCENTRATE
### A IV 4/14/2014 ABELEI INC 148A76 NATURAL GRAPE FLAVOR
### I II 12/29/2015 CHEMWERTH INC NEPAFENAC STERILE BULK DRUG SUBSTANCE
### A II 5/21/2014 ASTRAZENECA PHARMACEUTICALS LP METOPROLOL SUCCINATE EXTENDED
RELEASE/HYDROCHLOROTHIAZIDE
25/12.5,50/12.5 AND100/12.5 TABLETS
### A III 4/11/2014 SHANDONG DAWN POLYMER CO LTD THERMOPLASTIC VULCANIZATE FOR
PHARMACEUTICAL STOPPERS AND SEALS
### A II 4/18/2014 AMOLI ORGANICS PVT LTD DICLOFENAC
### A II 5/23/2014 CLAROCHEM IRELAND LTD CL1109
### A II 4/25/2014 UNIMARK REMEDIES LTD DORIPENEM CRUDE (INTERMEDIATE)
28211 A II 4/30/2014 PAR PHARMACEUTICAL INC MIDODRINE HYDROCHLORIDE USP
### I II 5/3/2014 AURONEXT PHARMA PRIVATE LTD DORIPENEM MONOHYDRATE (STERILE)
### A III 4/14/2014 VERSALIS SPA PHARMALENE BC 82 PH
### A III 4/14/2014 VERSALIS SPA PHARMALENE MP 90 PH
### A III 4/14/2014 VERSALIS SPA RIBLENE FL 34 F
### A V 4/22/2015 AEGIS THERAPEUTICS LLC INTRAVAIL® FUNCTIONAL EXCIPIENT
### A II 4/21/2014 SYMED LABS LTD LANTHANUM CARBONATE
### A III 4/10/2014 SONA EXTRUSION PVT LTD ALUMINIUM COLLAPSIBLE TUBES AND
CONTAINERS
### A III 7/24/2014 STURGIS MOLDED PRODUCTS AUXILIARY COMPONENTS
### A II 5/6/2014 SYNBIAS PHARMA AG VINORELBINE TARTRATE
### A II 5/30/2014 S AND B PHARMA INC DBA NORAC SPB-10101 DRUG SUBSTANCE
PHARMA
### A II 1/5/2017 ALP PHARM BEIJING CO LTD POSACONAZOLE FOMR I
### A III 4/17/2014 HUHTAMAKI PPL LTD FLEXIBLE LAMINATES, POUCHES (IN 2PLY, 3PLY,
4PLY), SPECIALIZED CARTONS AND LABELS
Page 889
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 5/27/2014 MEDICHEM MANUFACTURING MALTA DABIGATRAN ETEXILATE MESYLATE
LTD
### A III 4/27/2014 AMISHA VINYLS PVT LTD NON-TOXIC RIGID PVC FILM FOR
PHARMACEUTICAL BLISTER PACKAGING, FOOD
PRODUCTS AND THERMOFORMING
APPLICATIONS
### A IV 4/25/2014 PFANSTIEHL INC D-GALACTOSE, PLANT DERIVED, HIGH PURITY
LOW ENDOTOXIN, USP/NF, EP (G-126-1)
### A IV 11/3/2014 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET-10275299]
### A II 6/19/2014 EMCURE PHARMACEUTICALS LTD FINGOLIMOD HYDROCHLORIDE
### I IV 4/18/2014 KERRY INGREDIENTS AND FLAVOURS 30625750 NAT FL MODULATOR (MASKING) FMTr
DBA MASTERTASTE INC
### I IV 4/18/2014 KERRY INGREDIENTS AND FLAVOURS 30625760 NAT FL MODULATOR (MASKING) FMT r
DBA MASTERTASTE INC PWD
### I IV 4/18/2014 KERRY INGREDIENTS AND FLAVOURS 30625759 NAT FL MOD (MASKING) FMT r SD
DBA MASTERTASTE INC
### I IV 4/21/2014 KERRY INGREDIENTS AND FLAVOURS 30627948 NAT FL MODULATOR (MASKING) FMT r
DBA MASTERTASTE INC PWD
### I IV 4/18/2014 KERRY INGREDIENTS AND FLAVOURS 30625761 NAT FL MODULATOR (MASKING) FMT r
DBA MASTERTASTE INC PWD
### I IV 4/21/2014 KERRY INGREDIENTS AND FLAVOURS 30627945 NAT FL MODULATOR (MASKING) FMT r
DBA MASTERTASTE INC PWD
### A II 5/14/2014 URQUIMA SA ALBACONAZOLE
### I IV 4/18/2014 KERRY INGREDIENTS AND FLAVOURS 30625757 NAT FL MOD (MOUTHFEEL) FMT r
DBA MASTERTASTE INC
### A II 4/28/2014 ACEBRIGHT INDIA PHARMA PRIVATE LTD LOPINAVIR [DRUG SUBSTANCE (NON-STERILE)]
Page 894
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 6/30/2014 CADILA HEALTHCARE LTD DULOXETINE HYDROCHLORIDE USP (PROCESS-
II)
### A II 6/16/2014 SOLARA A PHARMA SCIENCES LTD ERTAPENEM SODIUM
### A II 6/30/2014 DR REDDYS LABORATORIES LTD MIRABEGRON [PRODUCT CODE: AEB]
### A III 6/15/2014 ADHESIVES RESEARCH INC A4493 (SR-26)
### A III 6/15/2014 ADHESIVES RESEARCH INC A-5181 (MA-111)
### A II 8/22/2014 SUN PHARMACEUTICAL INDUSTRIES DABIGATRAN ETEXILATE MESYLATE
LTD
### A II 6/30/2014 PIRAMAL ENTERPRISES LTD PREGABALIN
### A II 7/8/2014 EMCURE PHARMACEUTICALS LTD NEOSTIGMINE METHYLSULFATE USP
### I II 6/17/2014 SHODHANA LABORATORIES LTD DULOXETINE HYDROCHLORIDE USP
### I IV 6/18/2014 FONA INTERNATIONAL INC 915.1071U STRAWBERRY FLAVOR, NAT & ART
### A II 10/22/2014 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET-10275198]
### A II 7/30/2014 LUPIN LTD VILAZODONE HYDROCHLORIDE
### A IV 6/18/2014 SPI PHARMA INC PHARMABURST® 530
### A II 6/10/2014 SHANDONG XINHUA PHARMACEUTICAL IBUPROFEN SODIUM
CO LTD
### A II 6/26/2014 BEIJING HUIKANG BOYUAN CHEMICAL LINAGLIPTIN
TECH CO LTD
### A II 7/11/2014 DR REDDYS LABORATORIES LTD LOMUSTINE USP
### A IV 6/12/2014 JIAOZUO ZHONGWEI SPECIAL POVIDONE
PRODUCTS PHARMACEUTICAL CO LTD
### A IV 6/16/2014 JIAOZUO ZHONGWEI SPECIAL CROSPOVIDONE
PRODUCTS PHARMACEUTICAL CO LTD
### A II 6/19/2014 VIWIT PHARMACEUTICAL CO LTD LULICONAZOLE
### A IV 9/25/2015 CAPSUGEL MANUFACTURING INC VCAPS® DRCAPS™ EMPTY HARD CAPSULES
28411 A II 6/26/2014 SOLARA A PHARMA SCIENCES LTD LORATADINE USP
### A II 7/7/2014 ZACH SYSTEM SA ABIRATERONE ACETATE
### A II 9/23/2014 JIANGSU HENGRUI MEDICINE CO LTD DESFLURANE, USP, NON-STERILE, BULK DRUG
SUBSTANCE
### I II 10/7/2014 PATHEON API MANUFACTURING INC TRAVOPROST, USP
### A II 6/19/2014 UNION QUIMICO FARMACEUTICA SA MIVACURIUM CHLORIDE
### A II 6/20/2014 ASYMCHEM LABORATORIES TIANJIN CO SAPROPTERIN
LTD
### A II 7/21/2014 SUN PHARMACEUTICAL INDUSTRIES LURASIDONE HYDROCHLORIDE
LTD
### A II 7/29/2014 ITF CHEMICAL LTDA BENDAMUSTINE HYDROCHLORIDE
### A II 7/10/2014 ZHEJIANG HUAHAI PHARMACEUTICAL DABIGATRAN ETEXILATE MESYLATE
CO LTD
### A II 6/25/2014 OPTIMUS DRUGS PRIVATE LTD (1R)-2-[(2-(4-NITROPHENYL) ETHYL] AMINO] -1-
PHENYL ETHANOL. HCL (MIRABEGRON
INTERMEDIATE)
### A II 6/21/2014 HIKAL LTD BUPROPION HYDROCHLORIDE USP [PROCESS-
2]
### I II 6/13/2014 SKUNY BIOSCIENCE CO LTD ICOSAPENT ETHYL
Page 895
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 7/8/2014 CEDARBURG PHARMACEUTICALS INC ATROPINE SULFATE, USP
### A II 7/28/2014 GLAND PHARMA LTD SODIUM PHENYLACETATE
### I II 6/16/2014 SKUNY BIOSCIENCE CO LTD DOCOSAHEXAENOIC ACID ETHYL ESTER
### A IV 6/16/2014 HENKEL CORP GELVA GMS 737 PRESSURE SENSITIVE
ADHESIVE
### A V 6/26/2014 DDP SPECIALTY ELECTRONIC DOW CORNING™ SILAC HYBRID PRESSURE
MATERIALS US 9 LLC SENSITIVE ADHESIVES
### A III 6/20/2014 BERRY GLOBAL (BPREX PHARMA HDPE PLASTIC CONTAINER
PACKAGING INDIA PRIVATE LTD)
### A III 6/30/2014 TERUMO CORP I-COATING™ STOPPERS
### A II 6/30/2014 SMS PHARMACEUTICALS LTD LEVETIRACETAM USP
### A II 7/22/2014 MEDICHEM SA NEPAFENAC
### A II 7/28/2014 AARTI INDUSTRIES LTD VENLAFAXINE HYDROCHLORIDE POLYMORPH B
### A III 12/15/2014 BAXTER HEALTHCARE CORP VIAFLO CONTAINER CLOSURE SYSTEM
### A II 8/8/2014 MYLAN LABORATORIES LTD COBICISTAT ON SILICON DIOXIDE
### A II 7/16/2014 EMCURE PHARMACEUTICALS LTD 4'-ACETYLOXY 2, 4-DIFLUOROBIPHENYL
### A II 9/4/2014 MYLAN LABORATORIES LTD ROFLUMILAST
### A II 6/20/2014 MINAKEM BUDESONIDE MICRONIZED
### A II 7/15/2014 AUROBINDO PHARMA LTD DABIGATRAN ETEXILATE MESYLATE
### A II 8/4/2014 TORRENT PHARMACEUTICALS LTD GUANFACINE HYDROCHLORIDE USP
### A II 7/2/2014 CHINOIN PHARMACEUTICAL AND OLMESARTAN MEDOXOMIL USP
CHEMICAL WORKS PRIVATE CO LTD
### A II 1/19/2015 APAC PHARMACEUTICAL LLC LWJXS API
### A II 8/28/2014 DR REDDYS LABORATORIES LTD TICAGRELOR
### A II 7/9/2014 INTAS PHARMACEUTICALS LTD LURASIDONE HYDROCHLORIDE
### A II 7/22/2014 AUROBINDO PHARMA LTD LURASIDONE HYDROCHLORIDE
### A IV 6/16/2014 TIANJIN BOKELIN MEDICAL PACKAGING POLYETHYLENE GLYCOL 4000
TECHNOLOGY CO LTD
### A IV 6/16/2014 TIANJIN BOKELIN MEDICAL PACKAGING POLYETHYLENE GLYCOL 6000
TECHNOLOGY CO LTD
### A II 8/14/2014 HEC PHARM CO LTD AZILSARTAN KAMEDOXOMIL NON-STERILE BULK
DRUG SUBSTANCE
### A II 10/23/2014 HEC PHARM CO LTD AZITHROMYCIN MONOHYDRATE NON-STERILE
BULK DRUG SUBSTANCE
### A II 9/28/2014 HEC PHARM CO LTD ESCITALOPRAM OXALATE NON-STERILE BULK
SUBSTANCE
### A II 7/31/2014 PIRAMAL ENTERPRISES LTD BACLOFEN
Page 896
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I II 7/1/2014 PHARMARESOURCES (KAIYUAN) CO LTD TICAGRELOR (CAS: 274693-27-5)
Page 898
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 3/18/2015 POLYCARBON INDUSTRIES INC DBA PCI PCI-104500 NON-STERILE BULK DRUG
SYNTHESIS SUBSTANCE
### A II 8/1/2014 OLON SPA PERHEXILINE MALEATE
### A IV 7/30/2014 SOCIETE INDUSTRIELLE DES REFINED SOYBEAN OIL IV
OLEAGINEUX
### I IV 7/31/2014 FONA INTERNATIONAL INC 825.0445U CHERRY FLAVOR, NAT & ART
### A II 7/28/2014 HUBEI BIOCAUSE HEILEN HOMATROPINE METHYLBROMIDE
PHARMACEUTICAL CO LTD
### A II 7/31/2014 CHONGQING DAXIN PHARMACEUTICAL MEVASTATIN
CO LTD
### A II 8/1/2014 BACHEM AMERICAS INC VASOPRESSIN, USP (BULK)
### A II 6/10/2015 ABRAXIS BIOSCIENCE LLC A WHOLLY IDN 5404 ALBUMIN-BOUND PARTICLES FOR
OWNED SUB OF CELGENE CORP INJECTABLE SUSPENSION (COMPANY CODE:
ABI-011)
### A III 7/31/2014 RENEWSYS INDIA PVT LTD COLD FORMING ALUMINIUM FOIL LAMINATE FOR
PACKING
### A II 4/14/2015 ABRAXIS BIOSCIENCE LLC A WHOLLY RAPAMYCIN PROTEIN BOUND PARTICLE FOR
OWNED SUB OF CELGENE CORP INJECTABLE SUSPENSION (COMPANY CODE:
ABI-009)
### I IV 7/25/2014 PJ HEALTHCARE INNOJIT™
### I II 9/2/2014 DR REDDYS LABORATORIES LTD CAPECITABINE [PROCESS-II]
### I IV 8/1/2014 MASTERTASTE INC DBA KERRY INC 30634656 NAT FL MOD (MASKING) FMT ® SD
### A III 8/4/2014 NANTONG HUIDESENG PACKAGING COLD FORMING FOIL
MATERIAL CO LTD
### A II 9/25/2014 AMPAC FINE CHEMICALS LLC TAPENTADOL HCI
### I IV 7/31/2014 FONA INTERNATIONAL INC 807.0602U N-C BERRY FLAVOR, ART
### A II 8/5/2014 IRVINE SCIENTIFIC SALES CO INC PRIME-XVT OSTEOGENIC DIFFERENTIATION
SFM
### A III 7/31/2014 INDORAMA VENTURES POLYMERS POLYETHYLENE TEREPHTHALATE RESINS
MEXICO S DE RL DE CV
### I IV 7/31/2014 FONA INTERNATIONAL INC 815.0074U BUBBLE GUM FLAVOR,NAT & ART
### A II 7/25/2014 LUOHE NANJIECUN PHARMACEUTICAL RIFAMYCIN S
GROUP PHARMACY CO LTD
### A II 7/8/2014 CHINA GATEWAY PHARMACEUTICAL MONTELUKAST SODIUM
DEVELOPMENT CO LTD
### A II 7/3/2014 SHOUGUANG FUKANG ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
PHARMACEUTICAL CO LTD
### I IV 8/6/2014 FONA INTERNATIONAL INC 884.0244U N-C ORANGE FLAVOR, NAT WONF
### A II 7/30/2014 CHONGQING HUAPONT PARICALCITOL
PHARMACEUTICAL CO LTD
### I II 7/30/2014 CHONGQING HUAPONT MOXIFLOXACIN HCL
PHARMACEUTICAL CO LTD
### A II 8/7/2014 BRIGHTGENE BIOMEDICAL FONDAPARINUX INTERMEDIATE FSC
TECHNOLOGY CO LTD
### A IV 8/4/2014 MASTERTASTE INC DBA KERRY INC 30632117 NAT FL MOD (MASKING) FMT®
Page 899
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 9/30/2014 WAVELENGTH ENTERPRISES LTD FLUTICASONE FUROATE
### A IV 8/8/2014 RAMA INDUSTRIES LTD GELATINE B
### A II 9/23/2014 RELIANCE LIFE SCIENCES PVT LTD SORAFENIB TOSYLATE
### A IV 8/4/2014 MASTERTASTE INC DBA KERRY INC 30631914 N&A COOLING FL FMT®
### A II 8/13/2014 SOLARA A PHARMA SCIENCES LTD ALBENDAZOLE
### I IV 8/14/2014 FONA INTERNATIONAL INC 944.0660U N-C TROPICAL BLEND FLAVOR, NAT &
ART
### I IV 8/14/2014 FONA INTERNATIONAL INC 926.1292U N-C VANILLA CREME FLAVOR, NAT &
ART
### A II 10/16/2014 AREVIPHARMA GMBH DIMETHYL FUMARATE
### A II 10/9/2014 EMCURE PHARMACEUTICALS LTD PEMETREXED DISODIUM HEMIPENTAHYDRATE
### A II 9/16/2014 TOPHARMAN SHANDONG CO LTD ARIPIPRAZOLE
### A III 8/15/2014 MEADWESTVACO CALMAR GMBH HIMARK™ CR SPRAYER MEDICAL DEVICE
### A II 1/28/2015 SIGNA SA DE CV ATAZANAVIR SULFATE
### I II 8/14/2014 YABAO PHARMACEUTICAL GROUP CO DIPYRIDAMOLE USP
LTD
### A II 11/18/2014 LUPIN LTD METAXALONE USP
### A II 8/8/2014 ANHUI WORLDBEST PHARMACEUTICAL L-MENTHOL USP
CO LTD
### A III 8/18/2014 DUYTAN PLASTICS MANUFACTURING HDPE/PET PHARMACEUTICAL PACKAGING
CORP
### A III 2/19/2014 BORMIOLI PHARMA SPA PE BOTTLE
### A III 8/19/2014 INOVYN EUROPE LTD INOVYN TM PVC 258RD
### A II 12/31/2014 CADILA PHARMACEUTICALS LTD BUPROPION HYDROCHLORIDE USP
### A IV 8/15/2014 MASTERTASTE INC DBA KERRY INC 30621251 NAT Fl MOD (MASKING) FMT® SD
### A IV 8/15/2014 MASTERTASTE INC DBA KERRY INC 30631976 NAT Fl MOD (MASKING) FMT® SD
### A IV 8/15/2014 MASTERTASTE INC DBA KERRY INC 30631971 NAT Fl MOD (MASKING) FMT® SD
### A IV 8/15/2014 MASTERTASTE INC DBA KERRY INC 30621242 NAT Fl MOD (MASKING) FMT® SD
### A IV 8/18/2014 MASTERTASTE INC DBA KERRY INC 30632403 N&A RASPBERRY FL
### A II 9/25/2014 AMPAC FINE CHEMICALS LLC TEMOZOLOMIDE
### A II 10/1/2014 ALKEM LABORATORIES LTD ESOMEPRAZOLE MAGNESIUM DIHYDRATE
### A III 8/14/2014 FLEX FILMS EUROPA SP ZOO BI-AXIALLY ORIENTED POLYETHYLENE
TEREPHTHALATE (BOPET) FILMS
### A II 8/18/2014 ZHEJIANG JIANGBEI PHARMACEUTICAL SIMVASTATIN (WITH 0.01% BHA)
CO LTD
### A II 8/26/2014 HANGZHOU ZHONGMEI HUADONG FONDAPARINUX SODIUM
PHARMACEUTICAL CO LTD
### A III 8/13/2014 ARAYMONDLIFE PLASTIC INJECTION MOLDED CLOSURE
SYSTEM
### A II 6/9/2014 JINZHOU JIUTAI PHARMACEUTICAL CO BENZOCAINE
LTD
### A II 2/18/2015 APAC PHARMACEUTICAL LLC DYCLONINE HYDROCHLORIDE USP
### A III 8/20/2014 AMPACET CORP 404449-K AMCLEAR 49
### A III 8/8/2014 HIMALAYAN CAPSCON INDUSTRIES HDPE DRY SYRUP BOTTLES, SCREW CAPS AND
MEASURING CAPS
Page 900
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 8/26/2014 ASYMCHEM LIFE SCIENCE TIANJIN CO SUMATRIPTAN SUCCINATE
LTD
### A III 8/26/2014 FLEXTRUS AB TRANSOFOIL E-OPET/l 2481134-0004
(UNPRINTED) AND 2281134-0003 (PRINTED)
### A IV 8/20/2014 UNGERER AND CO NAT/ART MANGO FLVP FV-658
### I IV 8/28/2014 FONA INTERNATIONAL INC 915.0543U STRAWBERRY FLAVOR, NAT & ART
### A III 7/27/2014 GREEN PACK FOILS PRIVATE LTD BLISTER PACK LIDDING FOIL WITH
POLYETHYLENE AS SELANT LAYER
### A III 7/27/2014 GREEN PACK FOILS PRIVATE LTD CHILD RESISTANT BLISTER PACK LIDDING FOIL:
PET FILM BASED
### A II 9/5/2014 ZHEJIANG HISUN PHARMACEUTICAL CO LINEZOLID
LTD
### A II 10/31/2014 HISUN PHARMACEUTICAL NANTONG CO MOXIFLOXACIN HYDROCHLORIDE USP
LTD
### A II 9/9/2014 JUBILANT GENERICS LTD BOSENTAN MONOHYDRATE
### A II 9/17/2014 CADILA HEALTHCARE LTD PHTHALOYL AMLODIPINE
### A IV 8/20/2014 UNGERER AND CO NAT/ART MASKING FLVP FV-9111
### A II 10/7/2014 WOCKHARDT BIO AG PALIPERIDONE USP
### A III 7/18/2014 ICM PLASTICS PVT LTD RIGID PVC FILM/PVDC COATED PVC FILM/PVC
FILM LAMINATED WITH PE AND COATED WITH
PVDC
### A III 9/9/2014 LYONDELLBASELL AUSTRALIA PTY LTD MOPLEN HP400L POLYPROPYLENE
HOMOPOLYMER
### A III 9/8/2014 POLYPACIFIC PTY LTD PROPAK 7021 40% TALC FILLED
POLYPROPYLENE HOMOPOLYMER COMPOUND
Page 902
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 9/3/2014 JIANGXI HONGYUAN PHARMACEUTICAL PROGESTERONE
CO LTD
### A II 10/22/2014 CADILA HEALTHCARE LTD VILAZODONE HYDROCHLORIDE
### A II 10/31/2014 CADILA HEALTHCARE LTD ROFLUMILAST
### A II 9/29/2014 BEIJING HUIKANG BOYUAN CHEMICAL IVABRADINE HYDROCHLORIDE
TECH CO LTD
### A II 10/7/2014 AMOLI ORGANICS PVT LTD ROSUVASTATIN CALCIUM
### I II 7/11/2015 ENALTEC LABS PRIVATE LTD CINACALCET HYDROCHLORIDE
### A II 11/23/2015 ENALTEC LABS PRIVATE LTD FELBAMATE USP
### A IV 12/17/2014 CAPSUGEL MANUFACTURING INC EMPTY TWO PIECE HARD ENTERIC DRUG
DELIVERY CAPSULES
### A II 9/19/2014 HIKAL LTD PREGABALIN USP
### A II 9/25/2014 LI-COR INC IRDYE 800CW CARBOXYLATE
### A II 9/23/2014 SHANDONG CHENZHONG ENOXAPARIN SODIUM USP
BIOPHARMACEUTICAL CO LTD
### A III 9/23/2014 EMS CHEMIE NORTH AMERICA INC GRIVORY GV-6H NATURAL
### A III 9/23/2014 EMS CHEMIE NORTH AMERICA INC GRIVORY XE 3706 WHITE 6513
### A III 9/23/2014 EMS CHEMIE NORTH AMERICA INC GRIVORY XE 3706 BLACK 9915
### A III 9/23/2014 EMS CHEMIE NORTH AMERICA INC GRIVORY XE 3706 GREY 9242
### A III 9/23/2014 EMS CHEMIE NORTH AMERICA INC GRIVORY XE 3706 GREY 9243
### A III 9/23/2014 EMS CHEMIE NORTH AMERICA INC GRIVORY XE 3707 GREY 9241
### A III 9/23/2014 EMS CHEMIE NORTH AMERICA INC GRIVORY XE 3707 NATURAL
### A III 9/23/2014 EMS CHEMIE NORTH AMERICA INC GRIVORY HT3 XE 4027 BLACK 9916
### A II 9/24/2014 ZAKLADY FARMACEUTYCZNE TICAGRELOR
POLPHARMA SA
### A II 9/22/2014 LIAOYUAN SILVER EAGLE ETHACRIDINE LACTATE MONOHYDRATE
PHARMACEUTICAL CO LTD
### A II 10/8/2014 MEDICHEM SA MED-300006/E (INTERMEDIATE)
### A II 10/15/2014 MANNKIND CORP AFREZZA® INHALATION POWDER AND
AFREZZA® INHALER
### A II 9/26/2014 NOF CORP ALPHA-(3'-{[1,2-
DI(MYRISTYLOXY)PROPANOXY]CARBONYLAMIN
O}PROPYL)-OMEGA-METHOXY,
POLYOXYETHYLENE
### A V 9/26/2014 BIOGEN IDEC US LTD PARTNERSHIP FACILITIES AND EQUIPMENT INFORMATION
### A II 9/25/2014 QINHUANGDAO ZIZHU DIENOGEST (MICRONIZED)
PHARMACEUTICAL CO LTD
### I II 9/19/2014 ZHEJIANG HISOAR PHARMACEUTICAL STLTDO
CO LTD
### I IV 9/29/2014 SD FINE CHEM LTD ADENINE USP
### A IV 9/29/2014 SD FINE CHEM LTD CALAMINE BP
### A IV 9/29/2014 SD FINE CHEM LTD CLOVE OIL BP
### A IV 9/29/2014 SD FINE CHEM LTD CREATININE USP
### A IV 9/29/2014 SD FINE CHEM LTD DIBASIC SODIUM PHOSPHATE ANHYDROUS USP
Page 903
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 9/29/2014 SD FINE CHEM LTD DIPOTASSIUM HYDROGEN PHOSPHATE BP
### A IV 9/29/2014 SD FINE CHEM LTD GLACIAL ACETIC ACID BP
### A II 10/1/2014 EMCURE PHARMACEUTICALS LTD (S)- METHYL-3- (4-BIS(2-HYDROXYETHYL)
AMINO) PHENYL) -2 - (TERT-
BUTOXYCARBONYLAMINO) PROPANOATE
### A IV 9/29/2014 SD FINE CHEM LTD MAGNESIUM SULPHATE BP
### A IV 9/29/2014 SD FINE CHEM LTD MENTHOL BP
### A IV 9/29/2014 SD FINE CHEM LTD POTASSIUM DIHYDROGEN PHOSPHATE BP
### A IV 9/29/2014 SD FINE CHEM LTD POTASSIUM IODIDE USP
### A IV 9/29/2014 SD FINE CHEM LTD SODIUM CITRATE USP
### A IV 9/29/2014 SD FINE CHEM LTD SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE
BP
### A IV 9/29/2014 SD FINE CHEM LTD STARCH BP
### A II 9/22/2014 PERLMAN SCOTT MD MS [18] FLT, 3'-DEOXY-3'-[18F] FLUOROTHYMIDINE
### I III 9/26/2014 AMPACET CORP 4600454-N TRANS LIGHT BLUE SMC PP MB
### A II 9/28/2014 ASYMCHEM LIFE SCIENCE TIANJIN CO SALMETEROL XINAFOATE
LTD
### A II 9/28/2014 YABAO PHARMACEUTICAL GROUP CO DIMETHYL FUMARATE
LTD
### A II 10/8/2014 INDUSTRIALE CHIMICA SRL ABIRATERONE ACETATE USP
### A II 10/10/2014 INTAS PHARMACEUTICALS LTD VILAZODONE HYDROCHLORIDE (AMORPHOUS)
### A III 10/1/2014 SANVIC INC KS PACK
### A II 11/6/2014 KYOWA HAKKO KIRIN CO LTD KOMEGA-6356 DRUG SUBSTANCE
### A IV 10/3/2014 SD FINE CHEM LTD ACETONE USP
### A IV 10/3/2014 SD FINE CHEM LTD BENZYL ALCOHOL BP
### A IV 10/3/2014 SD FINE CHEM LTD BORIC ACID BP
### A IV 10/3/2014 SD FINE CHEM LTD CITRIC ACID ANHYDROUS USP
### A IV 10/3/2014 SD FINE CHEM LTD CITRIC ACID MONOHYDRATE BP
### A IV 10/3/2014 SD FINE CHEM LTD DEXTROSE ANHYDROUS USP
28711 A IV 10/3/2014 SD FINE CHEM LTD DICHLOROMETHANE BP
### A IV 10/3/2014 SD FINE CHEM LTD DISODIUM EDTA USP
### A IV 10/3/2014 SD FINE CHEM LTD GLYCERINE BP
### A IV 10/3/2014 SD FINE CHEM LTD HYDROGEN PEROXIDE SOLUTION 6% BP
### A IV 10/3/2014 SD FINE CHEM LTD ISOPROPYL ALCOHOL USP
### A IV 10/3/2014 SD FINE CHEM LTD LIQUID PARAFFIN BP
### A IV 10/3/2014 SD FINE CHEM LTD MANNITOL USP
### A IV 10/3/2014 SD FINE CHEM LTD SODIUM CHLORIDE USP
### A IV 10/3/2014 SD FINE CHEM LTD SODIUM HYDROXIDE PELLETS BP
### A IV 10/3/2014 SD FINE CHEM LTD WHITE SOFT PARAFFIN BP
### A II 10/14/2014 AUROBINDO PHARMA LTD DOLUTEGRAVIR SODIUM
### A III 9/25/2014 SILICAGEL PRODUCTS G CO SILICA GEL CANISTERS 0.5G, 1.0G, & 3.0G
### A II 9/30/2014 EDMOND PHARMA SRL LURASIDONE HYDROCHLORIDE
### A III 10/2/2014 BPREX HEALTHCARE OFFRANVILLE SAS OPHTHALMIC BOTTLES
Page 905
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 9/7/2014 PRINT N PACK PRINTED/PLAIN BLISTER FOIL, STRIP FOIL, ALU-
ALU COLD FORM FOIL, GLASSINE
### A II 12/8/2014 JIANGSU HANSOH PHARMACEUTICAL PEMETREXED DIACID, NON-STERILE, BULK
GROUP CO LTD DRUG SUBSTANCE
### A III 10/16/2014 RAVAGO MANUFACTURING AMERICAS CRYSTALADD® HM-237B
### A III 10/14/2014 ROBIN INDUSTRIES INC I-341050-07
### A II 11/30/2014 ASPEN GLOBAL INC FONDAPARINUX SODIUM USP
### A II 12/22/2014 SIGNA SA DE CV PAROXETINE HYDROCHLORIDE HEMIHYDRATE
USP
### A II 10/30/2014 TEVA PHARMACEUTICAL INDUSTRIES ABIRATERONE ACETATE
LTD
### A II 3/19/2015 MACLEODS PHARMACEUTICALS LTD ATORVASTATIN CALCIUM TRIHYDRATE
### A II 11/19/2014 ZHEJIANG HUAHAI PHARMACEUTICAL LINAGLIPTIN
CO LTD
### A II 1/30/2015 DR REDDYS LABORATORIES LTD LINAGLIPTIN
### A III 11/6/2014 CREDENCE MEDSYSTEMS INC CREDENCE COMPANION™ GUIDE-ON™ NEEDLE
Page 907
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 11/30/2017 TEVA PHARMACEUTICAL INDUSTRIES RIVAROXABAN
LTD
### A II 1/27/2015 CERBIOS PHARMA SA TIOTROPIUM BROMIDE
### A II 12/19/2014 ZHEJIANG YONGTAI PHARMACEUTICAL METOPROLOL TARTRATE USP
CO LTD
### A III 11/3/2014 LEADMEDI INHALER OVER CAP
### A II 11/26/2014 BACHEM AG TETRACOSACTIDE
### A II 3/31/2016 IPCA LABORATORIES LTD VALSARTAN USP
### A II 11/12/2014 VASUDHA PHARMA CHEM LTD DESLORATADINE
### A II 5/3/2018 NEULAND LABORATORIES LTD POSACONAZOLE
### A III 11/12/2014 POLYONE CORP CC00021179XX
### I II 11/17/2014 LIFECORE BIOMEDICAL LLC SODIUM HYALURONATE, LSA-9850025 PROCESS
Page 908
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 11/20/2014 SD FINE CHEM LTD DIBASIC SODIUM PHOSPHATE
DODECAHYDRATE USP
### A IV 11/20/2014 SD FINE CHEM LTD DIBASIC SODIUM PHOSPHATE DIHYDRATE USP
### A IV 11/20/2014 SD FINE CHEM LTD ANHYDROUS DISODIUM HYDROGEN
PHOSPHATE BP
### A IV 11/20/2014 SD FINE CHEM LTD DIPOTASSIUM HYDROGEN PHOSPHATE BP
### A IV 11/20/2014 SD FINE CHEM LTD MONOBASIC SODIUM PHOSPHATE DIHYDRATE
USP
### A IV 11/20/2014 SD FINE CHEM LTD POTASSIUM HYDROGEN PHOSPHATE
### A IV 11/20/2014 SD FINE CHEM LTD SODIUM PHOSPHATE
### A IV 11/20/2014 SD FINE CHEM LTD MONOBASIC POTASSIUM PHOSPHATE USP
### A II 1/7/2015 UNICHEM LABORATORIES LTD PRASUGREL HYDROCHLORIDE
### A II 12/2/2014 EMCURE PHARMACEUTICALS LTD SM ARG-I
### A III 11/12/2014 SIMAL PACKAGING PVT LTD ALUMINIUM COLLAPSIBLE TUBES
### A II 1/16/2015 GLENMARK PHARMACEUTICALS LTD RIVAROXABAN
### A II 7/7/2016 DR REDDYS LABORATORIES LTD IRON SUCROSE
### I II 12/5/2014 VIWIT PHARMACEUTICAL CO LTD APREPITANT
### A II 3/10/2015 GLENMARK PHARMACEUTICALS LTD IVACAFTOR
### A II 3/27/2015 GLENMARK PHARMACEUTICALS LTD ARFORMOTEROL TARTRATE
### A II 1/31/2015 MSN ORGANICS PRIVATE LTD DIMETHYL FUMARATE [ROUTE CODE "DV"]
### A II 11/19/2014 ISOCHEM SAS SOLIFENACIN SUCCINATE
### I IV 11/17/2014 TOMITA PHARMACEUTICAL CO LTD USP MAGNESIUM OXIDE HEAVY POWDER
### I IV 11/17/2014 TOMITA PHARMACEUTICAL CO LTD USP MAGNESIUM OXIDE HEAVY FINE
### A II 11/26/2014 NOF CORP POLY(OXY-1,2-ETHANEDIYL), ALPHA-METHYL
-OMEGA-{6-[(2,5-DIOXO-1 -PYRROLIDINYL)OXY]-
6-OXOHEXYLOXY}
### A III 10/31/2014 CONSOLIDATED BOTTLE CORP 18MM WHITE LDPE NASAL SPRAY PLUG [CBC
009084]
### A III 11/26/2014 POLYONE CORP CC00002623XX
### A III 11/25/2014 PRECISION MEDICAL INC A COMAR LLC PLASTIC PACKAGING
CO
### A II 1/7/2015 HONOUR LAB LTD LINAGLIPTIN
### A II 1/7/2015 HONOUR LAB LTD LINAGLIPTIN PREMIX
### A II 1/7/2015 HONOUR LAB LTD TICAGRELOR
### A II 1/21/2015 TEVA PHARMACEUTICAL INDUSTRIES TICAGRELOR
LTD
### A III 11/13/2014 QENOS PTY LTD ALKATANE® HD0490
### A II 12/3/2014 KREITCHMAN PET CENTER PBR28 C11 INJECTION
### A IV 11/26/2014 NIPPON FINE CHEMICAL CO LTD A LIPOSOMAL EXCIPIENT, DIOLEOYL
PHOSPHATIDYLCHOLINE (DOPC)
### A IV 11/26/2014 NIPPON FINE CHEMICAL CO LTD A LIPOSOMAL EXCIPIENT, DIOLEOYL
PHOSPHATIDYLETHANOLAMINE (DOPE)
### A II 2/16/2015 ZHEJIANG HUAHAI PHARMACEUTICAL AMLODIPINE BESYLATE USP
CO LTD
### A II 1/14/2015 THINQ PHARMA-CRO LTD CETIRIZINE HYDROCHLORIDE USP
Page 909
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 1/12/2015 GLENMARK PHARMACEUTICALS LTD ROSUVASTATIN CALCIUM (D122 PROCESS)
### A II 12/30/2014 CTD HOLDINGS INC TRAPPSOL™ CYCLO®
### A III 11/27/2014 S S ENTERPRISES LAMINATED, COATED, PRINTED/PLAIN BLISTER
FOIL, STRIP FOIL, ALU-ALU COLD FORM FOIL,
CR FOIL, GLASSINE, LAMINATES, POUCHES,
PVC, TAGGERS, WADS
### A III 12/3/2014 SAINT GOBAIN PERFORMANCE ALUMINIZED POLYESTER FILM C/1/S WITH 8310
PLASTICS SILICONE RELEASE COATING, AND COS WITH
4130 SILICONE RELEASE COATING
### A IV 12/3/2014 STAR TECH &JRS SPECIALTY POVIDONE
PRODUCTS CO LTD
### A III 12/1/2014 AICELLOMILIM CHEMICAL CO LTD CLEAN BAG LAS-04
### A III 11/18/2014 HEBEI FIRST RUBBER MEDICAL BROMINATED BUTYL RUBBER STOPPER FOR
TECHNOLOGY CO LTD INJECTION
### A III 11/18/2014 HEBEI FIRST RUBBER MEDICAL BROMINATED BUTYL RUBBER STOPPER FOR
TECHNOLOGY CO LTD INJECTION STERILE POWDER
### A II 12/22/2014 SUN PHARMACEUTICAL INDUSTRIES ACITRETIN USP
LTD
### A II 4/2/2015 TEVA PHARMACEUTICAL INDUSTRIES FEBUXOSTAT
LTD
### A II 3/16/2016 ALEMBIC PHARMACEUTICALS LTD TERIFLUNOMIDE
### A II 1/9/2015 ALEMBIC PHARMACEUTICALS LTD TICAGRELOR
### A II 12/31/2014 ALEMBIC PHARMACEUTICALS LTD VARDENAFIL HYDROCHLORIDE USP
### A II 12/10/2014 MEDICHEM MANUFACTURING MALTA BEPOTASTINE BESILATE
LTD
### A III 12/1/2014 AMPACET CORP 1600955-K BLUE 955
### A III 12/2/2014 3M DRUG DELIVERY SYSTEMS 3M SCOTCHPAKT 9755W RELEASE LINER
### A III 11/28/2014 JAYANTI ELASTOMER PROCESSOR SILICONE AND VITON RUBBER TUBES/SLEEVES,
STRIPS, CORDS, SHEETS, GASKETS, O RINGS
AND OTHER RUBBER PARTS
Page 911
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/22/2014 IRVINE SCIENTIFIC SALES CO PRIME-XV® ADIPOGENIC DIFFERENTIATION SFM
### A III 12/20/2014 RENOLIT PLASTIC TECH BJ LTD PP MEDICAL GRANULE FOR IV INNER CAP
### A III 12/20/2014 RENOLIT PLASTIC TECH BJ LTD PP MEDICAL GRANULE FOR IV SOFT PLASTIC
BOTTLE
### A II 12/26/2014 IRVINE SCIENTIFIC SALES CO PRIME-XV® CHONDROGENIC DIFFERENTIATION
XSFM
### A II 12/29/2014 IRVINE SCIENTIFIC SALES CO PRIME-XV® FREEZIS
### A IV 12/24/2014 NUSIL TECHNOLOGY LLC CSF-3101
### A II 4/2/2015 SHANGHAI PHARMA GROUP VALACYCLOVIR HYDROCHLORIDE
CHANGZHOU KONY PHARMACEUTICAL
CO LTD
### A III 12/17/2014 ARMOR SAS APR 600 THERMAL TRANSFER RIBBON
### A II 2/19/2015 SUN PHARMACEUTICAL INDUSTRIES LINAGLIPTIN
LTD
### A IV 12/29/2014 STAR -TECH & JRS SPECIALTY CROSPOVIDONE
PRODUCTS CO LTD
### A II 4/2/2015 SHANGHAI PHARMA GROUP GANCICLOVIR
CHANGZHOU KONY PHARMACEUTICAL
CO LTD
### A III 12/19/2014 AMPACET CORP 111717 WHITE PE MB
### A II 12/29/2014 QILU ANTIBIOTICS LINYI MEROPENEM WITH SODIUM CARBONATE
PHARMACEUTICAL CO LTD
Page 912
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 1/8/2015 KYONGBO PHARMACEUTICAL CO LTD OLANZAPINE
### I II 1/9/2015 KYONGBO PHARMACEUTICAL CO LTD SOLIFENACIN SUCCINATE
### A II 12/25/2014 HUBEI BIOCAUSE HEILEN ATROPINE SULFATE
PHARMACEUTICAL CO LTD
### A III 12/20/2014 SHAILY ENGINEERING PLASTICS LTD SEPL CHILD RESISTANT CLOSURES AND HDPE
BOTTLES
### A IV 12/26/2014 ZHEJIANG QUHUA FLUOR CHEMISTRY NORFLURANE
CO LTD
### A IV 12/10/2014 ZHEJIANG HUAGUANG CAPSULE CO LTD VACANT GELATIN CAPSULES
### A II 12/31/2014 ZHEJIANG GUOBANG PHARMACEUTICAL AZAERYTHROMYCIN (U-GRADE)
CO LTD
### A II 3/30/2015 TARO PHARMACEUTICAL INDUSTRIES DEFERIPRONE
LTD
### A II 1/14/2015 CHANGZHOU PHARMACEUTICAL TICAGRELOR
FACTORY
### A II 1/2/2015 ALKALOIDS CORP HYOSCINE
### A II 1/5/2015 ASYMCHEM LIFE SCIENCE TIANJIN CO ERLOTINIB HYDROCHLORIDE
LTD
### A II 12/18/2014 LIAOYUAN SILVER EAGLE METOCLOPRAMIDE HYDROCHLORIDE
PHARMACEUTICAL CO LTD
### A III 12/31/2014 HANGZHOU RUIJING PACKAGING CO 24MM CRC CAPS, 28MM CRC CAPS
LTD
### A II 12/25/2014 HYBIO PHARMACEUTICAL CO LTD GLATIRAMER ACETATE, NON-STERILE BULK
DRUG SUBSTANCE
### A II 12/31/2014 ZHEJIANG XIANJU JUNYE 11-ADDITION SUBSTANCE
PHARMACEUTICAL CO LTD
### A II 3/20/2015 GLENMARK PHARMACEUTICALS LTD TERIFLUNOMIDE
### A II 3/18/2015 GLENMARK PHARMACEUTICALS LTD FOSAPREPITANT DIMEGLUMINE
### A II 1/23/2015 INTERQUIM SA RIVAROXABAN
### A II 2/10/2015 DAEWOONG BIO INC URSODIOL USP (PROCESS II)
### A II 1/21/2015 AUROBINDO PHARMA LTD FEXOFENADINE HYDROCHLORIDE USP
### A II 1/30/2015 CHEMWERTH INC FOSCARNET SODIUM USP
### A II 3/10/2015 LUSOCHIMICA SPA ALBUTEROL SULFATE
### A II 1/7/2015 SAFC INC TRYPAN BLUE
### A II 2/18/2015 ZHEJIANG YONGTAI PHARMACEUTICAL FENOFIBRATE USP
CO LTD
### A IV 1/8/2015 STAR-TECH & JRS SPECIALTY COPOVIDONE
PRODUCTS CO LTD
### A II 3/3/2015 CHEMWERTH INC BOSENTAN, NON-STERILE BULK DRUG
SUBSTANCE
### A II 3/11/2015 GLENMARK PHARMACEUTICALS LTD TOFACITINIB CITRATE
### A II 1/8/2015 HOVIONE FARMACIENCIA SA MINOCYCLINE HYDROCHLORIDE MICRONIZED
### A II 1/12/2015 SYMBIOTEC PHARMALAB PRIVATE LTD DEHYDROEPIANDROSTERONE (INTERMEDIATE)
Page 913
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 1/22/2015 EVEREST ORGANICS LTD OMEPRAZOLE CHLORO COMPOUND USE AS
INTERMEDIATE
### I II 2/17/2015 HARMAN FINOCHEM LTD PROPOFOL USP
### A III 11/18/2014 HEBEI FIRST RUBBER MEDICAL INJECTION OF BROMINATED BUTYL RUBBER
TECHNOLOGY CO LTD STOPPER WAS DRIED BY FREEZE
### A III 1/5/2015 ELASTO TECH INDUSTRIES PVT LTD SILICONE RUBBER TUBING PLATINUM CURED
AND BRAIDED
### A V 2/19/2015 ARWAN PHARMACEUTICAL INDUSTRIES STERILE FACILITY
### A II 3/13/2015 PIRAMAL ENTERPRISES LTD ENTACAPONE
29011 A II 3/16/2015 EMCURE PHARMACEUTICALS LTD TOLTERODINE TARTRATE
### A II 2/13/2015 MICRO LABS LTD TICAGRELOR
### A IV 1/22/2015 HUANGSHAN BONSUN CROSPOVIDONE
PHARMACEUTICALS CO LTD
### A II 3/4/2015 RELIANCE LIFE SCIENCES PVT LTD SUNITINIB MALATE
### A II 1/14/2015 VASUDHA PHARMA CHEM LTD KETOROLAC TROMETHAMINE USP
### A III 1/6/2015 DIVYA PACKING PVT LTD ALUMINIUM COLLAPSIBLE PRINTED TUBES &
CONTAINERS
### A II 1/31/2015 CADILA HEALTHCARE LTD LINAGLIPTIN AMORPHOUS
### A II 9/25/2015 CHEMWERTH INC TRIENTINE HYDROCHLORIDE USP
### A II 3/31/2015 GLENMARK PHARMACEUTICALS LTD DIPYRIDAMOLE USP
### A III 1/7/2015 ALUCA INDUSTRIES PRINTED/PLAIN BLISTER FOILS, ALUMINIUM
FOILS, ALU-ALU FOIL, PVC FOILS, CR FOILS AND
HDPE / PP BOTTLES AND JARS
### A IV 1/15/2015 NICHIRIN CHEMICAL INDUSTRIES LTD GRANFILLER-D GNF-D211
### A II 1/20/2015 SYMBIOTEC PHARMALAB PRIVATE LTD TESTOSTERONE CYPIONATE USP
### A V 6/17/2015 MEDINSTILL DEVELOPMENT LLC I INTACT® FILLING SYSTEM
### A III 1/17/2015 SINCURE INDUSTRIES PRINTED/PLAIN BLISTER FOILS, ALUMINIUM
FOILS, ALU-ALU FOIL, PVC FOILS, CR FOILS AND
HDPE / PP BOTTLES AND JARS
### A II 2/4/2015 UNICHEM LABORATORIES LTD OLMESARTAN MEDOXOMIL USP
### A II 2/3/2015 UNICHEM LABORATORIES LTD TADALAFIL USP
### A II 1/30/2015 CIPLA LTD TEMOZOLOMIDE USP
### A II 3/13/2015 CIPLA LTD BOSENTAN MONOHYDRATE
### A II 1/20/2015 SYMBIOTEC PHARMALAB PRIVATE LTD 17-a HYDROXYPROGESTERONE
(INTERMEDIATE)
### A III 1/15/2015 AMPACET CORP AMPACET 13839 BACON BRD YELLOW PE MB
### A III 1/14/2015 AMPACET CORP 17168-25 GREEN PE MB
### A II 3/31/2015 APOTEX PHARMACHEM INC RIVASTIGMINE USP
### A II 3/27/2015 APOTEX PHARMACHEM INC RUFINAMIDE USP
### A II 3/30/2015 APOTEX PHARMACHEM INC DEXLANSOPRAZOLE ANHYDRATE
### A II 1/6/2015 VM CHEMICALS SODIUM CHLORIDE BP
### A II 1/6/2015 VM CHEMICALS SODIUM BICARBONATE BP
### A II 1/6/2015 VM CHEMICALS SODIUM ACETATE TRIHYDRATE BP
### A II 1/6/2015 VM CHEMICALS POTASSIUM CHLORIDE BP
### A III 1/20/2015 AMPACET CORP 10069 ANTISTAT PE MB
Page 914
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 1/20/2015 AMPACET CORP 101140 AS PE MB
### A III 1/26/2015 NIPRO INDIA CORP PVT LTD RUBBER STOPPER FOR DRUG
### A III 1/23/2015 GERRESHEIMER PEACHTREE CITY LP DUAL STRIP DRY POWDER INHALER
COMPONENTS
### A II 1/21/2015 NIFTY LABS PVT LTD 2-[[[3-METHYL-4-(2,2,2-TRIFLUORO ETHOXY)-2-
PYRIDINYL] METHYL] SULFANYL]-1H-
BENZIMIDAZOLE
### A III 1/13/2015 WESTERN RUBBERSINDIA PVT LTD SILICONE RUBBER TUBING & HOSE, SEALS &
GASKETS
### A II 1/22/2015 OLON SPA RIFABUTIN
### A II 2/5/2015 AUROBINDO PHARMA LTD RIVAROXABAN
### A IV 2/2/2015 HUANGSHAN BONSUN POVIDONE
PHARMACEUTICALS CO LTD
### A II 4/30/2015 PCAS CINACALCET HCL
### A II 2/20/2015 CTX LIFE SCIENCES PVT LTD MESALAMINE USP
### A III 1/26/2015 POLYONE CORP CC10212038XX
### A II 3/24/2015 JOHNSON MATTHEY PHARMA SERVICES 4237.G
### A III 1/26/2015 HSIAO SUNG NON OXYGEN CHEMICAL O-BUSTER (DRYBOY) DESICCANT
CO LTD
### A III 1/26/2015 SAKAMOTO LIME INDUSTRY CO LTD LIME DESICCANT
### A II 2/5/2015 LIANYUNGANG RUNZHONG FOSCARNET SODIUM, NON STERILE, BULK
PHARMACEUTICAL CO LTD DRUG SUBSTANCE
### A II 2/3/2015 CHANGZHOU PHARMACEUTICAL ATORVASTATIN CALCIUM (TRIHYDRATE)
FACTORY
### A II 5/13/2015 SAI LIFE SCIENCES LTD METHENAMINE HIPPURATE USP
### A II 1/29/2015 NIFTY LABS PVT LTD DIBENZO [B,F] [1,4] THIAZEPIN-11 (10H)-ONE
### A II 2/2/2015 LI-COR INC IRDYE 700DX CARBOXYLATE(DRUG SUBSTANCE
INTERMEDIATE)
### A II 1/27/2015 CAMBREX PROFARMACO MILANO SRL CLOBAZAM
### A II 3/23/2015 SAI LIFE SCIENCES LTD 4-((2-CYANOPROPAN-2-YL)AMINO)-2-FLUORO-N-
METHYLBENZAMIDE (ENZALUTAMIDE
INTERMEDIATE)
### A II 5/25/2015 CIPLA LTD OLANZAPINE USP
### A II 2/27/2015 DR REDDYS LABORATORIES LTD MIRABEGRON [FORM - AMORPHOUS]
### A II 2/25/2015 RAKS PHARMA PVT LTD TICAGRELOR
### A II 3/18/2015 RAKS PHARMA PVT LTD RIVAROXABAN
### A II 1/24/2015 JIAOZUO JOINCARE THYMIDINE
BIOTECHNOLOGICAL CO LTD
### A II 1/29/2015 WUHAN ZY PHARMACEUTICAL CO LTD POSA-12 (POSACONAZOLE INTERMEDIATE)
### A III 2/3/2015 TAISEI KAKO CO LTD PLASTIC SYRINGES WITH NEEDLE
### A IV 3/28/2015 PLANET SCIENCE POLYETHYLENE GLYCOL 400 MONOSTEARATE
(P1154)
### A II 2/4/2015 IRVINE SCIENTIFIC SALES CO INC PRIME-XV® FREEZIS DMSO-FREE
### A II 2/4/2015 IRVINE SCIENTIFIC SALES CO PRIME-XV® IS21 SUPPLEMENT (50X) PRODUCT
NUMBER 91142
Page 915
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 2/4/2015 CHROMA CORP PC502199 BLUE COLOR CONCENTRATE
### I III 1/30/2015 AMPACET CORP 466600 HR BLUE PP MB
### A IV 2/6/2015 NICHIBAN CO LTD ACRYLIC COPOLYMER
### I II 2/24/2015 TEVA PHARMACEUTICAL INDUSTRIES TERIPARATIDE ACETATE
LTD
### A II 3/13/2015 JUSTESA IMAGEN SAU IOTHALAMIC ACID
### A II 1/31/2015 JOYANG LABORATORIES FUSIDIC ACID
### A II 2/5/2015 ZHEJIANG NEO DANKONG ESOMEPRAZOLE SODIUM (NON-STERILE BULK
PHARMACEUTICAL CO LTD DRUG SUBSTANCE)
### A II 2/27/2015 TEVA PHARMACEUTICAL INDUSTRIES FERRIC CITRATE
LTD
### A II 6/19/2015 TEVA PHARMACEUTICAL INDUSTRIES SUCROFERRIC OXYHYDROXIDE
LTD
### A II 8/27/2015 TEVA PHARMACEUTICAL INDUSTRIES TRIENTINE HYDROCHLORIDE USP
LTD
### A II 2/6/2015 CHANGZHOU BOHIV PHARMACEUTICAL L-6
TECHNOLOGY CO LTD
### A III 2/26/2015 HB FULLER CO SWIFT®THERM 84493
### A III 2/16/2015 CONSTANTIA OAI HUNG ALUMINIUM BLISTER FOIL & ALUMINIUM LIDDING
MANUFACTURING JOINT FOIL
### A IV 2/13/2015 FONA INTERNATIONAL INC 825.0344U CHERRY FLAVOR, NAT
### A II 3/23/2015 CIPLA LTD GEFITINIB
### A II 3/2/2015 SIEGFRIED USA LLC BUPRENORPHINE
### A III 2/12/2015 AMPACET CORP 465804 PURPLE SLIP PP MB
### A III 2/4/2015 ROCHLING MEDICAL NEUHAUS GMBH INFUSION BOTTLE SERIE WITH CLINCH NECK
AND CO KG AND LOOP AT BASE (P 3879, P 3880, P 3881)
### A II 4/14/2015 AREVIPHARMA GMBH KETAMINE HYDROCHLORIDE
### A II 2/11/2015 CHONGQING HUAPONT BENDAMUSTINE HCI MONOHYDRATE
PHARMACEUTICAL CO LTD
### A III 2/10/2015 WESTERN POLYRUB INDIA PVT LTD SILICONE TUBING & HOSE, SEALS & GASKETS
### A II 3/4/2015 AUROBINDO PHARMA LTD DIVALPROEX SODIUM USP
### A II 3/14/2015 AZICO BIOPHORE INDIA PVT LTD LEVOTHYROXINE SODIUM
### A II 2/21/2015 SUPRIYA LIFESCIENCE LTD PYRILAMINE MALEATE USP
### A II 2/10/2015 KUNMING GUIYAN PHARMACEUTICAL CARBOPLATIN DRUG SUBSTANCE
CO LTD
### A II 4/28/2015 MACLEODS PHARMACEUTICALS LTD PROPYLTHIOURACIL
### A II 4/13/2015 ACS DOBFAR SPA ERTAPENEM SODIUM
### A II 2/25/2015 KANEKA EUROGENTEC SA PRODUCTION OF PLASMID DNA (DRUG
SUBSTANCE, VERSION 2)
### A II 3/9/2015 INDUSTRIALE CHIMICA SRL FULVESTRANT USP
### A III 2/27/2015 VERSALIS SPA PHARMALENE MP 20 PH
### A III 2/27/2015 VERSALIS SPA PHARMALENE FL 20 PH
### A III 2/27/2015 ASAHI GLASS CO LTD AGC CHEMICALS FLUON™ ETFE FILM
CO
Page 916
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 2/27/2015 CELANESE EVA POLYMERS ETHYLENE VINYL ACETATE COPOLYMER,
VITALDOSE® K2534.X01
### A III 2/24/2015 TRUDELL MEDICAL INTERNATIONAL TOP MOUNTED ACTUATION INDICATOR (TMAI) -
P/N 102547
29110 A IV 2/27/2015 CELANESE EVA POLYMERS ETHYLENE VINYL ACETATE COPOLYMER
VITALDOSE® K2465.X01
29111 A IV 2/27/2015 CELANESE EVA POLYMERS ETHYLENE VINYL ACETATE COPOLYMER,
VITALDOSE® K2466.X01
29112 A III 2/27/2015 WINPAK HEAT SEAL PACKAGING INC FORMABLE FOIL PACKAGING MATERIALS
29113 A II 3/2/2015 VASUDHA PHARMA CHEM LTD OLMESARTAN MEDOXOMIL USP
29114 A II 4/1/2015 LUSOCHIMICA SPA SILVER SULFADIAZINE
29116 A II 4/7/2015 JOYANG LABORATORIES BACITRACIN
29117 A II 3/31/2015 DR REDDYS LABORATORIES LTD ENZALUTAMIDE
29118 A II 4/9/2015 LUPIN LTD DARUNAVIR N-PROPANOLATE
29119 A II 2/27/2015 TIANJIN PHARMACEUTICAL HOLDINGS CEFDINIR USP
GENCOM PHARMACY CO LTD
### A II 8/4/2017 CODY LABORATORIES INC COCAINE HYDROCHLORIDE, USP
### A II 3/12/2015 MSN PHARMACHEM PRIVATE LTD APREPITANT USP (FORM-I) [ROUTE CODE "FA"]
### A II 4/1/2015 RICHTER-HELM BIOTEC GMBH AND CO TERIPARATIDE
KG
### A II 3/26/2015 PIRAMAL ENTERPRISES LTD BISOPROLOL FUMARATE
### A II 4/13/2015 SHILPA MEDICARE LTD ERLOTINIB HYDROCHLORIDE (ET)
### A II 3/31/2015 CIPLA LTD ABIRATERONE ACETATE
### A II 3/31/2015 DR REDDYS LABORATORIES LTD DIMETHYL FUMARATE
### A III 3/3/2015 SPARTECH LLC 121108-C
### A II 3/2/2015 WUHU FOMAN BIOPHARMA CO LTD L-A-GLYCERYLPHOSPHORYLCHOLINE
### A II 3/4/2015 SMS PHARMACEUTICALS LTD PANTOPRAZOLE SODIUM USP
### A III 3/6/2015 HAJDUK PLASTICNA AMBALAZA DOO HDPE BOTTLES
### A III 3/6/2015 TVORNICA FARMACEUTSKE AMBALAZE AMPOULES
DOO
### A II 3/30/2015 MSN LABORATORIES PRIVATE LTD EZETIMIBE USP [ROUTE CODE "EE"]
### A II 3/20/2015 MSN ORGANICS PRIVATE LTD RIVASTIGMINE USP [ROUTE CODE "RP"]
### A II 5/4/2015 MSN PHARMACHEM PRIVATE LTD ATAZANAVIR SULFATE [ROUTE CODE "AQ"]
### A II 3/31/2015 MSN PHARMACHEM PRIVATE LTD ARIPIPRAZOLE USP MONOHYDRATE [ROUTE
CODE-HA]
### I II 2/27/2015 LIVZON GROUP FUZHOU FUXING DAPTOMYCIN
PHARMACEUTICAL CO LTD
### A II 3/24/2015 AMOLI ORGANICS PVT LTD ARIPIPRAZOLE USP
### A II 5/15/2015 MSN ORGANICS PRIVATE LTD CLOPIDOGREL BISULFATE USP (FORM-II)
[ROUTE CODE - 'CM2']
### A II 2/23/2015 SHANGHAI AJINOMOTO AMINO ACID CO L-PHENYLALANINE
LTD
### A II 2/23/2015 SHANGHAI AJINOMOTO AMINO ACID CO L-VALINE
LTD
Page 917
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 2/23/2015 SHANGHAI AJINOMOTO AMINO ACID CO L-ALANINE
LTD
### A II 2/23/2015 SHANGHAI AJINOMOTO AMINO ACID CO L-ISOLEUCINE
LTD
### A II 3/5/2015 ICROM SPA FLUORESCEIN SODIUM
### A II 3/6/2015 ASYMCHEM LABORATORIES FUXIN CO BETA-METHYL VINYL PHOSPHATE
LTD
### A II 5/7/2015 NORDMARK ARZNEIMITTEL GMBH AND COLLAGENASE NB 6 GMP GRADE
CO KG
### A II 3/31/2015 LUPIN LTD CINACALCET HYDROCHLORIDE
### A III 3/2/2015 AMPACET CORP 4500361-N RED SMC PP MB
### A III 3/3/2015 BOREALIS AG BORMED HE9621-PH
### A III 3/5/2015 BORMIOLI PHARMA SPA HDPE BOTTLE 500 ML
### I II 3/10/2015 ADVANCED ACCELERATOR KIT FOR PREPARATION OF 99M TC-RHANNEXIN
APPLICATIONS USA INC V-128
### A IV 3/2/2015 TAKASAGO INTERNATIONAL CORP POWDER NATURAL & ARTIFICIAL PEPPERMINT
FLAVOR TAK-130406
### A III 3/5/2015 AMPACET CORP 173001 LIME GRN SMC PP MB
### A II 3/6/2015 HEBEI CHANGSHAN BIOCHEMICAL DALTEPARIN SODIUM
PHARMACEUTICAL CO LTD
### A II 3/9/2015 NIFTY LABS PVT LTD 2-CHLOROMETHYL-3-METHYL-4-(3-METHOXY
PROPOSY) PYRIDINE HYDROCHLORIDE
### A II 7/14/2015 MICRO LABS LTD SODIUM NITROPRUSSIDE USP
### A II 9/17/2015 MICRO LABS LTD DARUNAVIR ETHANOLATE
### A II 3/16/2015 HETERO LABS LTD EZETIMIBE
### A II 4/8/2015 LUPIN LTD ATAZANAVIR SULFATE (PROCESS B)
### A III 1/15/2015 BHASIN PACKWELL PVT LTD ALUMINIUM FLIP OFF SEAL/ALUMINIUM TEAR
OFF SEAL
### A II 3/31/2015 THINQ PHARMA-CRO LTD MECLIZINE HYDROCHLORIDE USP
### A II 3/25/2015 PIRAMAL ENTERPRISES LTD CINACALCET HYDROCHLORIDE
### A II 3/30/2015 PIRAMAL ENTERPRISES LTD LURASIDONE HYDROCHLORIDE
### A II 3/28/2015 PIRAMAL ENTERPRISES LTD CLOBAZAM
### A II 4/20/2015 INDUSTRIALE CHIMICA SRL ETONOGESTREL
### A II 3/11/2015 MACCO ORGANIQUES INC CALCIUM ACETATE
### A II 3/13/2015 HETERO LABS LTD CARBOPLATIN USP
### I II 3/11/2015 ZHEJIANG APELOA JIAYUAN PREGABALIN
PHARMACEUTICAL CO LTD
### A II 3/30/2015 JUBILANT GENERICS LTD ZOPICLONE
### A II 3/28/2015 JUBILANT GENERICS LTD LACOSAMIDE
### A IV 3/9/2015 DAVID MICHAEL AND CO INC NATURAL AND ARTIFICIAL LEMON FLAVOR
#24025
### A IV 3/9/2015 DAVID MICHAEL AND CO INC NATURAL CHERRY FLAVOR WONF #24827
### A IV 3/9/2015 DAVID MICHAEL AND CO INC ARTIFICIAL CHERRY FLAVOR #27912
### A IV 3/9/2015 DAVID MICHAEL AND CO INC NATURAL AND ARTIFICIAL ORANGE FLAVOR
#27876
Page 918
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### I III 3/6/2015 AMPACET CORP 4600513-N BLUE PP MB
### A III 3/4/2015 FUJIMORI KOGYO CO LTD RELEASE LINER FILM FOR USE IN
TRANSDERMAL DRUG DELIVERY PATCHES **E-
8811 BD/DG-3 OR DG-3/BD
### A III 3/6/2015 OG CORP EMBOSSED SILICONE PET FILM
### A V 3/17/2015 FRESENIUS KABI USA LLC STERILE MANUFACTURING FACILITY IN WILSON,
NC.
### A II 3/13/2015 ZHEJIANG HAIZHOU PHARMACEUTICAL GUAIFENESIN
CO LTD
### A II 3/16/2015 ZCL CHEMICALS LTD MEMANTINE HYDROCHLORIDE USP
### A V 4/12/2017 ELI LILLY AND CO PROCEDURE FOR STERILE OPERATIONS IN
BUILDING B105 - CARTRIDGE LINE
### A II 3/18/2015 HETERO DRUGS LTD DONEPEZIL HYDROCHLORIDE (ANHYDROUS)
### A II 6/10/2015 JIANGSU HANSOH PHARMACEUTICAL PEMETREXED DISODIUM HEMIPENTAHYDRATE,
GROUP CO LTD NON-STERILE, BULK DRUG SUBSTANCE
### A II 2/2/2015 SHANDONG XINHUA PHARMACEUTICAL OMEGA-3-ACID-ETHYL ESTERS
CO LTD
### A II 3/31/2015 WOCKHARDT BIO AG REGADENOSON (AMORPHOUS)
### A IV 12/17/2014 ARKEMA FRANCE EVATANE 1020VN3
### A IV 12/17/2014 ARKEMA FRANCE EVATANE 1040VN4
### A IV 12/17/2014 ARKEMA FRANCE EVATANE 28-25RG
### A III 3/17/2015 CAPSULIT SPA CHILD PROOF AND PILFER PROOF TAMPER
EVIDENT PLASTIC CLOSURES
### A II 12/3/2015 DELMAR CHEMICALS INC ROSUVASTATIN CALCIUM
### A II 3/31/2015 UNICHEM LABORATORIES LTD LURASIDONE HYDROCHLORIDE
### A II 6/12/2015 BASF AS OMEGA-3-ACID ETHYL ESTERS CAPSULES
### A III 3/1/2015 MONAK PACKAGING ALUMINIUM COLLAPSIBLE TUBES SUITABLE
FOR PACKAGING PHARMACEUTICAL DOSAGES
### A II 4/9/2015 PICHEM FORSCHUNGS UND DOTA-TATE
ENTWICKLUNGS GMBH
### A II 4/16/2015 PCAS ENCLOMIPHENE CITRATE
### A II 4/2/2015 TEVA PHARMACEUTICAL INDUSTRIES VILAZODONE HYDROCHLORIDE
LTD
### A II 3/31/2015 MSN LABORATORIES PRIVATE LTD NEOSTIGMINE METHYLSULFATE USP [ROUTE
CODE "NS"]
### A II 4/28/2015 GLAND PHARMA LTD NICARDIPINE HYDROCHLORIDE USP
### A II 3/31/2015 ALEMBIC PHARMACEUTICALS LTD RIVASTIGMINE USP
### A III 3/11/2015 SILICAGEL PRODUCTS G CO SILICA GEL POUCHES 0.5 G, 1 G, 2 G, 5 G, 50 G,
100 G, 250 G, & 500 G
### A II 3/17/2015 OSAKA SODA CO LTD DAISOGEL C4 SERIES
### A IV 5/27/2015 PEARL THERAPEUTICS INC POROUS PARTICLES
### A IV 3/25/2015 JRS PHARMA GMBH AND CO KG VIVACOAT® READY-TO-USE FILMCOATING
SYSTEM
### A II 2/27/2015 AMERICAN TARTARIC PRODUCTS INC POTASSIUM BITARTRATE, USP/FCC
Page 919
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 4/3/2015 MSN LABORATORIES PRIVATE LTD LORCASERIN HYDROCHLORIDE HEMIHYDRATE
[ROUTE CODE "LC"]
### A II 6/30/2015 MSN LABORATORIES PRIVATE LTD TAFLUPROST [ROUTE CODE "TU"]
### A II 8/12/2015 CHIROGATE INTERNATIONAL INC HEXADECYL TREPROSTINIL
### A II 3/26/2015 PERLMAN SCOTT MD MS (18F) FES,16 ALPHA-[18F]-FLUORO-
17BETAESTRADIOL
### A II 11/19/2015 TEVA PHARMACEUTICAL INDUSTRIES CAPECITABINE
LTD
### A II 7/10/2015 AMRI RENSSELAER INC EPINEPHRINE, USP
29211 A II 3/26/2015 ZCL CHEMICALS LTD ATOMOXETINE HYDROCHLORIDE USP
### I II 3/23/2015 VIWIT PHARMACEUTICAL CO LTD ATAZANAVIR SULFATE
### A II 3/26/2015 BCN PEPTIDES SA ICATIBANT ACETATE
### A II 3/20/2015 ZHEJIANG APELOA JIAYUAN IRON DEXTRAN
PHARMACEUTICAL CO LTD
### A II 3/27/2015 SOLARA A PHARMA SCIENCES LTD APREPITANT
### A II 3/27/2015 SOLARA A PHARMA SCIENCES LTD DEXTROMETHORPHAN POLISTIREX
### A II 3/26/2015 QINHUANGDAO ZIZHU TIBOLONE
PHARMACEUTICAL CO LTD
### A IV 3/30/2015 HENKEL CORP DURO-TAK 87-2052
### A III 3/18/2015 KP MANISH GLOBAL INGREDIENTS PVT ALU ALU COLD FORMING BLISTER FOIL
LTD
### A V 4/23/2015 KBI BIOPHARMA INC FACILITIES
### A II 3/30/2015 SYMBIOTEC PHARMALAB PRIVATE LTD HYDROCORTISONE HEMISUCCINATE USP
### A IV 3/11/2015 DOOSAN CORP DS-SODIUM OLEATE
### A II 3/30/2015 SYMBIOTEC PHARMALAB PRIVATE LTD 16A-HYDROXY PREDNISOLONE (INTERMEDIATE)
Page 923
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 7/17/2015 TRIS PHARMA INC HCD-CPM-PSEUD ER OS (HYDROCODONE
POLISTIREX, CHLORPHENIRAMINE POLISTIREX
AND PSEUDOEPHEDRINE POLISTIREX ER ORAL
SUSPENSION)
### A II 6/15/2015 KREITCHMAN PET CENTER FPEB F18 INJECTION
### A II 5/26/2015 MSN LABORATORIES PRIVATE LTD CABAZITAXEL [ROUTE CODE - ''CL'']
### A III 5/4/2015 DYNIC USA CORP THERMAL TRANSFER RIBBON HF12
### A IV 5/11/2015 HENKEL CORP GELVA GMS 2893 PRESSURE SENSITIVE
ADHESIVE
### A III 5/4/2015 DYNIC USA CORP THERMAL TRANSFER RIBBON HF29
### A III 5/4/2015 DYNIC USA CORP THERMAL TRANSFER RIBBON HT18
### A III 4/29/2015 ROCHLING MEDICAL NEUHAUS GMBH OSD BOTTLE SERIE ALLERGAN (P 4052, P4053,
AND CO KG P4065)
### A III 4/29/2015 ROCHLING MEDICAL NEUHAUS GMBH OSD BOTTLE SERIE STANDARD HPT
AND CO KG
### A II 5/6/2015 CAMBREX CHARLES CITY INC HYDROCODONE BITARTRATE
HEMIPENTAHYDRATE
### A II 5/11/2015 SYNBIAS PHARMA AG CLOFARABINE
### A II 8/12/2015 MACLEODS PHARMACEUTICALS LTD MOXIFLOXACIN HYDROCHLORIDE
### A II 9/29/2015 NORTH CHINA PHARMACEUTICAL FIDAXOMICIN
HUASHENG CO LTD
### A II 5/27/2015 MIDAS PHARMA GMBH 5-AMINOLEVULINIC ACID HYDROCHLORIDE
### A III 4/27/2015 TAIWAN DORENCY CO LTD OXYGEN ABSORBER
### A III 5/6/2015 LABLABO TWINBAG AIRLESS PUMPS AND BOTTLES
### A IV 5/11/2015 ASYMCHEM LIFE SCIENCE TIANJIN CO BETADEX SULFOBUTYL ETHER SODIUM
LTD
### A II 5/11/2015 IRVINE SCIENTIFIC SALES CO PRIME-XV® MSC EXPANSION XSFM
### A IV 5/14/2015 FONA INTERNATIONAL INC 807.0246U MIXED BERRY FLAVOR, NAT & ART
### A II 5/13/2015 AK AND MN BIOFARM CO LTD AK&MN BIOFARM OMEGA-3 ACID ETHYL ESTER
### A II 5/15/2015 COVALENT LABORATORIES PRIVATE LTD CEFPROZIL USP
### A III 5/14/2015 MINNESOTA RUBBER AND PLASTICS RUBBER ELASTOMERS FOR VASCULAR
APPLICATIONS
### A II 5/14/2015 SMS PHARMACEUTICALS LTD ROSIGLITAZONE MALEATE USP
### A IV 5/26/2015 FONA INTERNATIONAL INC 894.0022U PEPPERMINT FLAVOR, NAT & ART
(CANDY CANE )
### A II 5/11/2015 ZHEJIANG CHARIOTEER CLOPIDOGREL INTERMEDIATE P4
PHARMACEUTICAL CO LTD
### A II 5/30/2015 AUROBINDO PHARMA LTD ESOMEPRAZOLE MAGNESIUM DIHYDRATE
(PROCESS II)
### A II 9/30/2015 BIOCON LTD PIMECROLIMUS
### A V 6/5/2015 WEST PHARMACEUTICAL SERVICES INC PHARMACEUTICAL WASH PROCESS
Page 925
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 5/28/2015 FONA INTERNATIONAL INC 870.0235U FONATECH®MANGO FLAVOR, NAT
WONF
### A III 5/15/2015 AMPACET CORP 466579 PURPLE SMC PP MB
### A III 5/15/2015 INEOS STYROLUTION EUROPE GMBH NAS® RESINS
### A III 5/21/2015 TEKNOR APEX CO MEDALIST® MD-590 NAT
### A II 6/30/2015 MSN LABORATORIES PRIVATE LTD ALOGLIPTIN BENZOATE [ROUTE CODE "LB"]
### A II 6/6/2015 BIOPHORE INDIA PHARMACEUTICALS ETHACRYNIC ACID
PVT LTD
### A II 5/13/2015 KUNMING GUIYAN PHARMACEUTICAL OXALIPLATIN DRUG SUBSTANCE
CO LTD
### A III 6/15/2015 HOSPIRA INC CARPUJECT MINI™ SYRINGE SYSTEM
### A II 5/28/2015 GLOBAL CALCIUM PRIVATE LTD CALCIUM GLUCONATE MONOHYDRATE FOR
INJECTION
### A II 5/28/2015 BRIGHTGENE BIOMEDICAL PIMECROLIMUS INTERMEDIATE ASCOMYCIN
TECHNOLOGY CO LTD
### A II 6/10/2015 BEIJING HUIKANG BOYUAN CHEMICAL CANAGLIFLOZIN HEMIHYDRATE
TECH CO LTD
### A II 6/8/2015 FUJIAN YEWPARK BIOLOGICAL 10-DEACETYLBACCATIN III
PHARMACEUTICAL CO LTD
### I III 6/23/2015 NYPRO INC DEVICE COMPONENTS FOR LEVER OPERATED
MULTI-DOSE INHALER
### A II 5/28/2015 HIKMA PHARMACEUTICALS PLC ERLOTINIB HYDROCHLORIDE
### A IV 6/3/2015 GRUNENTHAL GMBH ALPHA-TOCOPHEROL/PEG POWDER
### A II 5/18/2015 ZHEJIANG SUPOR PHARMACEUTICALS RIVAROXABAN USP
CO LTD
### A II 6/2/2015 LUNAN NEW TIME BIO TECH CO LTD RAPAMYCIN
### A II 9/30/2015 FIS FABBRICA ITALIANA SINTETICI SPA INDOMETHACIN SODIUM
### A II 9/28/2015 BIOCON LTD DRUG SUBSTANCE INTERMEDIATE
IMMUNOMYCIN
### A II 11/13/2015 AMCOL HEALTH AND BEAUTY POLY-PORE® FLUOROURACIL POLYMER
SOLUTIONS INC
### A II 6/22/2015 APOTEX PHARMACHEM INC OLANZAPINE USP
### A II 10/29/2015 PERRIGO API LTD FEXOFENADINE HYDROCHLORIDE
### A II 6/28/2015 PERRIGO API LTD FULVESTRANT
### A II 6/1/2015 PORTON PHARMA SOLUTIONS LTD TIOPRONIN NON-STERILE BULK DRUG
### A II 6/20/2015 AURO PEPTIDES LTD OCTREOTIDE ACETATE
### A II 6/10/2015 MSN LABORATORIES PRIVATE LTD RIFAXIMIN [ROUTE CODE "RFB"]
### A III 6/4/2015 RENOLIT HANSEN PACKAGING TECH PULL OFF CAP AND PP PORT FOR INFUSION
(BJ) LTD BAG
### A II 6/30/2015 MYLAN LABORATORIES LTD POMALIDOMIDE
### A II 6/30/2015 MYLAN LABORATORIES LTD THALIDOMIDE USP
### A II 6/16/2015 ADARE PHARMACEUTICALS INC AR17 -APT5037 IR ORALLY DISINTEGRATING
TABLETS
### A II 6/29/2015 AMPHASTAR NANJING FLUTICASONE PROPIONATE, USP
PHARMACEUTICALS INC
Page 926
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 8/11/2015 LUPIN LTD DARUNAVIR (AMORPHOUS)
### A III 5/8/2015 UFLEX LTD (FILM DIV) BLISTER PACKAGING BOPET FILMS
### A IV 3/26/2015 SHREE CHEMICALS KADCOAT™ L100 (METHACRYLIC ACID CO-
POLYMER - A)
### A III 5/11/2015 VANDANA ELECTRONICS RUBBER STOPPERS, FLIP OFF SEALS, PLASTIC
HANGERS, POLYPROPYLENE CAPS AND
CLOSURES, MEASURING CUPS, BOTTLES FOR
SYRUP, EYE/EAR DROPPERS & PAEDIATRIC
DROPPERS
### A III 6/3/2015 AMPACET CORP 4600697-K BLUE 697
### A III 5/28/2015 TOYOBO CO LTD BACKING FOR PHARMACEUTICAL USE
### A II 6/18/2015 JIANGXI TIANXIN PHARMACEUTICAL CO THIAMINE HYDROCHLORIDE
LTD
### A II 6/26/2015 CHEMO IBERICA SA LANSOPRAZOLE (PROCESS II)
### A III 6/5/2015 HEINKE TECHNOLOGY INC PACKAGING MATERIAL, PLASTIC CONTAINER
AND APPLICATOR DEVICE
### A II 6/23/2015 FDC LTD OLOPATADINE HYDROCHLORIDE USP
### A III 5/5/2015 PLASTICOS BDS SRL LDPE CONTAINERS FOR LIQUID OPHTHALMIC
PRODUCTS REFERENCES IS037BLCB,
IS040BLCB, CAP IO140BLKS AND DROPTAINER
IO126NAAS
### A III 5/28/2015 CHENGDU PINGYUAN NIPRO NEUTRAL BOROSILICATE GLASS AMPOULE
PHARMACEUTICAL PACKAGING CO LTD
### A III 5/28/2015 CHENGDU PINGYUAN NIPRO NEUTRAL BOROSILICATE GLASS INJECTION
PHARMACEUTICAL PACKAGING CO LTD VIAL
### A II 6/30/2015 TEVA PHARMACEUTICAL INDUSTRIES ROTIGOTINE
LTD
### A II 6/14/2015 BIOLOGICAL INDUSTRIES ISRAEL BEIT- MSC NUTRISTEM® XF
HAEMEK LTD
### A III 6/10/2015 POLYONE CORP CC00017123XX
### A III 6/10/2015 POLYONE CORP CC10218445XX
### I II 6/12/2015 ASYMCHEM LABORATORIES FUXIN CO ERTAPENEM SODIUM
LTD
### A IV 5/28/2015 INDIA PHOSPHATE ANHYDROUS DIBASIC CALCIUM PHOSPHATE
USP
### A II 7/13/2015 TORRENT PHARMACEUTICALS LTD ANAGRELIDE HYDROCHLORIDE USP
### A II 7/10/2015 INDOCO REMEDIES LTD LACOSAMIDE
### A III 6/15/2015 VSN PLAS PACK POLYETHYLENE (PE) BAG/ POLYETHYLENE(PE)
SLEEVE
### A IV 5/28/2015 INDIA PHOSPHATE TRIBASIC CALCIUM PHOSPHATE NF
### A IV 5/28/2015 INDIA PHOSPHATE DIBASIC CALCIUM PHOSPHATE DIHYDRATE USP
Page 932
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 11/26/2015 WUHAN HEALTHGEN BIOTECHNOLOGY RECOMBINANT HUMAN SERUM ALBUMIN
CORP
### A II 9/15/2015 NJOY INC ELECTRONIC NICOTINE DELIVERY SYSTEM
### A II 11/6/2015 LUPIN LTD PITAVASTATIN SODIUM
### A II 9/30/2015 BIOCON LTD EVEROLIMUS (WITH 0.2% BHT)
### A II 9/14/2015 SHILPA MEDICARE LTD PEMETREXED DIPOTASSIUM (NONA HYDRATE)
(PMN)
### A II 9/18/2015 SHILPA MEDICARE LTD ANASTROZOLE USP
### A II 9/19/2015 SHILPA MEDICARE LTD DIMETHYL FUMARATE
### A II 8/27/2015 QILU TIANHE PHARMACEUTICAL CO LTD IMATINIB MESYLATE (NON-STERILE API)
### A II 9/30/2015 BIOCON LTD EVEROLIMUS
### A II 9/15/2015 CONCORD BIOTECH LTD PIMECROLIMUS
### A II 9/4/2015 ALEMBIC PHARMACEUTICALS LTD SILODOSIN
### A II 9/30/2015 ALEMBIC PHARMACEUTICALS LTD APIXABAN
### A II 9/29/2015 SHANGHAI TECHWELL MICAFUNGIN SODIUM
BIOPHARMACEUTICAL CO LTD
### A V 8/13/2015 NITTO DENKO AVECIA INC DESCRIPTION OF NITTO DENKO AVECIA, INC.
MANUFACTURING FACILITIES IN MILFORD, MA
### A III 8/12/2015 CONSOLIDATED BOTTLE CORP 500ML AMBER PET METRIC ROUND 28/400 [CBC
014893]
### A IV 7/29/2015 LIPOID GMBH LIPOID PE 18:1/18:1 (1, 2-DIOLEOYL-SN-
GLYCERO-3-PHOSPHOETHANOLAMINE; DOPE)
### A II 9/2/2015 ZHEJIANG HUAHAI PHARMACEUTICAL APIXABAN
CO LTD
### A II 9/29/2015 MICRO LABS LTD DABIGATRAN ETEXILATE MESYLATE
### A II 9/30/2015 MSN LABORATORIES PRIVATE LTD PHYTONADIONE USP [ROUTE CODE "HN"]
### A II 9/4/2015 MSN LABORATORIES PRIVATE LTD GEFITINIB [ROUTE CODE GN]
### A II 8/29/2015 MSN LABORATORIES PRIVATE LTD CARFILZOMIB [ROUTE CODE "CJ"]
### A II 9/29/2015 MSN LABORATORIES PRIVATE LTD AXITINIB [ROUTE CODE - "XA"]
### A II 10/12/2015 SOLARA A PHARMA SCIENCES LTD MEFENAMIC ACID USP ( PRODUCT CODE : 05P)
### I II 8/31/2015 HOSPIRA HEALTHCARE INDIA PVT LTD TAZOBACTAM USP (BH ROUTE)
### A II 1/12/2016 SIGNA SA DE CV MESALAMINE USP
### A II 9/7/2015 MACLEODS PHARMACEUTICALS LTD CINACALCET HYDROCHLORIDE
### A II 8/14/2015 MEGAFINE PHARMA P LTD PRASUGREL HYDROCHLORIDE
### A II 9/21/2015 QILU ANTIBIOTICS LINYI ERLOTINIB HYDROCHLORIDE
PHARMACEUTICAL CO LTD
### A II 9/11/2015 CADILA PHARMACEUTICALS LTD ARIPIPRAZOLE USP
### A II 10/30/2015 SHANGHAI TECHWELL PNEUMOCANDIN B0
BIOPHARMACEUTICAL CO LTD
### A II 11/12/2015 SHANGHAI TECHWELL CASPOFUNGIN ACETATE
BIOPHARMACEUTICAL CO LTD
### A II 10/19/2015 ADARE PHARMACEUTICALS INC MICROCAPS® IBUPROFEN
### A II 8/20/2015 HENAN LIHUA PHARMACEUTICAL CO HYDROCORTISONE ACETATE
LTD
### A II 11/3/2015 TRIS PHARMA INC COD-CPM-PSE ER ORAL SUSPENSION
Page 933
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 8/12/2015 HIKAL LTD PREGABALIN (PROCESS-II)
### A II 8/20/2015 ZAKLADY FARMACEUTYCZNE AVANAFIL
POLPHARMA SA
### A II 9/30/2015 DR REDDYS LABORATORIES LTD LENALIDOMIDE DIMETHYLFORMAMIDE SOLVATE
Page 935
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 9/19/2015 SUN PHARMACEUTICAL INDUSTRIES S-(+)-FLURBIPROFEN
LTD
### A II 11/12/2015 CHONGQING DAXIN PHARMACEUTICAL DAPTOMYCIN, NON-STERILE, BULK DRUG
CO LTD
### A III 8/11/2015 HIMSAN POLYMER PRIVATE LTD PLATINUM CURED SILICONE TUBES & BRAIDED
HOSES
### A III 9/5/2015 YASH PACKAGING CLEAR/ COLOURED PVC RIGID FILMS
### A II 9/7/2015 CAMBREX PROFARMACO MILANO SRL LACOSAMIDE
### A II 9/20/2015 HUBEI GEDIAN HUMANWELL DIHYDROFINASTERIDE
PHARMACEUTICAL CO LTD
### A II 12/4/2015 HONOUR LAB LTD TADALAFIL USP
### A II 9/29/2015 NAVINTA LLC MELPHALAN HYDROCHLORIDE
### A III 9/8/2015 POLYONE CORP S535.6
### A IV 9/10/2015 SYMRISE INC 242631 NATURAL & ARTIFICIAL VANILLA FLAVOR
POWDER WL-3021
### A II 9/26/2015 QILU PHARMACEUTICAL CO LTD CLOFARABINE
### A II 9/28/2015 QILU PHARMACEUTICAL CO LTD CARFILZOMIB (NON-STERILE, API)
### A II 9/25/2015 QILU ANTIBIOTICS LINYI AZACITIDINE
PHARMACEUTICAL CO LTD
### A II 9/24/2015 QILU ANTIBIOTICS LINYI GEFITINIB
PHARMACEUTICAL CO LTD
### A II 9/25/2015 MEGAFINE PHARMA P LTD MIRABEGRON DRUG SUBSTANCE
### A II 9/24/2015 ZHEJIANG HUAHAI PHARMACEUTICAL LEVOMILNACIPRAN HYDROCHLORIDE
CO LTD
### A II 5/20/2016 JOHNSON MATTHEY INC B1450
PHARMACEUTICAL MATERIALS GROUP
### A II 5/31/2016 JOHNSON MATTHEY PHARMA SERVICES SILODOSIN
### A II 12/21/2016 JOHNSON MATTHEY PHARMA SERVICES 4303.B
### A II 2/18/2016 JOHNSON MATTHEY PHARMA SERVICES 4250.B (ETHACRYNIC ACID)
### A II 6/1/2016 JOHNSON MATTHEY PHARMA SERVICES 4302.E
### A II 12/30/2015 JOHNSON MATTHEY PHARMA SERVICES 686.B
### A II 10/7/2015 AMPAC FINE CHEMICALS LLC DEXMETHYLPHENIDATE HCl API
### A II 9/29/2015 JUBILANT GENERICS LTD AZILSARTAN MEDOXOMIL POTASSIUM
### A II 9/24/2015 BIOCON LTD TACROLIMUS GRANULES 20% W/W
### A II 9/28/2015 GLAND PHARMA LTD FULVESTRANT USP
### A II 9/30/2015 GLAND PHARMA LTD TIGECYCLINE [MANUFACTURING SITE - II]
### A II 9/29/2015 AUROBINDO PHARMA LTD OLANZAPINE USP (CRYSTALLINE POLYMORPH
FORM-II)
### A III 9/10/2015 CAPSULIT SPA PLASTIC AND ALUMINUM CLOSURES FOR
INJECTABLES
### A II 9/14/2015 COVALENT LABORATORIES PRIVATE LTD CEFPODOXIME PROXETIL USP
Page 938
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/31/2015 SUN PHARMACEUTICAL INDUSTRIES EXENATIDE
LTD
### A II 9/30/2016 SUN PHARMACEUTICAL INDUSTRIES AZACITIDINE
LTD
### A II 12/31/2015 SUN PHARMACEUTICAL INDUSTRIES OLOPATADINE HYDROCHLORIDE USP
LTD
### A II 10/31/2015 MSN ORGANICS PRIVATE LTD CINACALCET HYDROCHLORIDE [ROUTE CODE
"CN"]
### A II 10/20/2015 MSN LIFE SCIENCES PRIVATE LTD CANAGLIFLOZIN (AMORPHOUS) [ROUTE CODE
"CU"]
### A II 10/31/2015 MSN ORGANICS PRIVATE LTD ATOMOXETINE HYDROCHLORIDE USP [ROUTE
CODE "MY"]
### A II 9/30/2015 SYMBIOTEC PHARMALAB PRIVATE LTD TESTOSTERONE USP (MICRONIZED)
### A II 11/3/2015 MSN LABORATORIES PRIVATE LTD REGORAFENIB [ROUTE CODE "RZ"]
### A II 11/3/2015 AMPHASTAR NANJING SODIUM NITROPRUSSIDE USP
PHARMACEUTICALS INC
### A II 5/24/2016 TEVA PHARMACEUTICAL INDUSTRIES ENZALUTAMIDE
LTD
### A II 11/6/2015 AMGEN INC AMG 191 DRUG SUBSTANCE
### A II 10/6/2015 MERCK KGAA UREA
### A III 8/31/2015 SHANGHAI YINGQI DESICCANT CO LTD YINGQI DESICCANT FOR DRUG PACKAGE
MATERIAL
### A II 11/9/2015 AMPHASTAR NANJING ISOPROTERENOL HYDROCHLORIDE USP
PHARMACEUTICALS INC
### A II 11/6/2015 AMGEN INC AMG 191 CELL LINE DEVELOPMENT
### A IV 10/2/2015 TRELYST LLC DDU-4830 SILICONE POLYMER EXCIPIENT
SYSTEM
### A IV 9/25/2015 FACI ASIA PACIFIC PTE LTD MAGNESIUM STEARATE, EUR. PHARM
### A III 10/2/2015 GLOPAK USA CORP 75CC AMBER PACKER
### A II 10/5/2015 SOLARA A PHARMA SCIENCES LTD MIDAZOLAM
### A II 10/5/2015 HETERO LABS LTD EZETIMIBE (FORM-B)
### A II 11/6/2015 AMGEN INC AMG 191 DRUG PRODUCT
### A II 8/16/2016 RHODES TECHNOLOGIES INC BUPRENORPHINE HYDROCHLORIDE, USP
### A II 10/5/2015 HANGZHOU JIUYUAN GENE FULVESTRANT
ENGINEERING CO LTD
### A II 10/21/2015 SHANGHAI YUKING WATER SOLUBLE POVIDONE-IODINE
MATERIAL TECH CO LTD
### A II 10/6/2015 OPTIMUS DRUGS PRIVATE LTD (R) -ALPHA-[[[2-(4-NITRO-PHENYL)-
ETHYL]AMINO]METHYL]BENZENE
METHANOL(MIRABEGRON INTERMEDIATE)
### A II 10/6/2015 OPTIMUS DRUGS PRIVATE LTD (R)-5-BROMO-3-[(1-METHYL-2-
PYRROLIDINYL)METHYL]-1H-INDOLE
(ELETRIPTAN INTERMEDIATE)
Page 939
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A V 9/25/2015 TRACE-ABILITY INC ANALYTICAL METHOD TO BE USED FOR
QUALITY CONTROL OF FLUDEOXYGLUCOSE
(FDG) 18 INJECTION
### A IV 10/6/2015 SYMRISE INC 914585 EVOSPRAY NATURAL GRAPE FLAVOR
WONF
### A IV 10/6/2015 SYMRISE INC 980361 EVOSPRAY NATURAL & ARTIFICIAL
FLAVOR, MIXED BERRY
### A IV 10/6/2015 SYMRISE INC 433975 EVOSPRAY NATURAL CHERRY FLAVOR
WONF
### A IV 10/7/2015 HENKEL CORP GELVA GMS 9073 PRESSURE SENSITIVE
ADHESIVE
### A IV 10/7/2015 HENKEL CORP GELVA GMS 9083 PRESSURE SENSITIVE
ADHESIVE
### I II 7/3/2015 WANBURY LTD PHENAZOPYRIDINE HYDROCHLORIDE DC
GRANULES
### A IV 10/6/2015 SIGMA ALDRICH IRELAND LTD N,N-DIMETHYLACETAMIDE (99.9%, PH EUR)
### A II 10/26/2015 MACLEODS PHARMACEUTICALS LTD DULOXETINE HYDROCHLORIDE DELAYED-
RELEASE PELLETS
### A II 11/23/2015 EMCURE PHARMACEUTICALS LTD MILRINONE USP
### A II 12/7/2015 MERCK KGAA TRISODIUM CITRATE DIHYDRATE
### A II 11/13/2015 HUYA BIOSCIENCE INTERNATIONAL HBI-8000 DRUG SUBSTANCE
### A II 1/8/2016 HUYA BIOSCIENCE INTERNATIONAL HBI-8000 DRUG PRODUCT
### A II 1/14/2016 ABBVIE SC-LD002 DRUG SUBSTANCE INTERMEDIATE
### A II 12/24/2015 LUPIN LTD LORCASERIN HYDROCHLORIDE PREMIX
29911 A IV 8/19/2016 TOLMAR INC BIODEGRADABLE POLYMER EXCIPIENTS
### A IV 10/12/2015 FONA INTERNATIONAL INC 884.0872U ORANGE CREME FLAVOR, NAT & ART
Page 941
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 11/9/2015 MACLEODS PHARMACEUTICALS LTD CYCLOBENZAPRINE HYDROCHLORIDE
EXTENDED RELEASE PELLETS
### I III 10/27/2015 LOPAREX LLC GRADE 54221 - C 48# CL PET H/H S928440/000
### A III 10/26/2015 VERSALIS SPA PHARMALENE MP 30 PH
### A III 8/24/2015 ALUTECH PACKAGING PVT LTD ALU-ALU FOIL (SILPACK)™, BLISTER FOIL, STRIP
FOIL PLAIN, COLORED AND PRINTED
### A III 10/26/2015 VERSALIS SPA PHARMALENE MR 10 PH
### A III 10/26/2015 VERSALIS SPA PHARMALENE FC 20 PH
### A IV 10/26/2015 DAVID MICHAEL AND CO INC NATURAL AND ARTIFICIAL CHOCOLATE FLAVOR
POWDER #50083
### A IV 10/26/2015 DAVID MICHAEL AND CO INC NATURAL FLAVOR CREAMY VANILLA #50043
O.S.
### A III 10/28/2015 POLYONE CORP EM10021584XX
### A IV 10/28/2015 SYMRISE INC 736912 EVOGLASS® NATURAL & ARTIFICIAL
LEMON FLAVOR 0.6MM
### A IV 10/26/2015 BASF SE KOLLICOAT® SMARTSEAL 100 P
### A III 10/27/2015 CHROMA CORP PC75912B 25/1 TRANS AMBER COLOR
CONCENTRATE
### A IV 10/29/2015 SYMRISE INC 243338 ENTRAPPED NATURAL & ARTIFICIAL
APPLE FLAVOR WL-5019
### A III 10/30/2015 BESPAK CONSORT MEDICAL PLC BK749 DRY POWDER INHALER (DPI)
### A IV 10/12/2015 NCPC BIOTECHNOLOGY BRANCH CO RECOMBINANT HUMAN SERUM ALBUMIN
### A II 11/30/2015 MEDICHEM SA MED-201080/E
### A II 11/23/2015 AMRI INDIA PVT LTD ATENOLOL USP DRUG SUBSTANCE
### A III 10/27/2015 SHIVAMANI PHARMA PACK PVT LTD TUBULAR GLASS VIALS USP I
### A II 11/28/2016 STERILE INDIA PVT LTD ESOMEPRAZOLE SODIUM (STERILE)
### A II 12/10/2015 LUPIN LTD FLUTICASONE PROPIONATE USP
### A IV 11/9/2015 SUDEEP PHARMA PVT LTD DI BASIC CALCIUM PHOSPHATE DIHYDRATE
USP
### A II 11/6/2015 CENTAUR PHARMACEUTICALS PRIVATE LOXAPINE SUCCINATE USP
LTD
### A III 10/22/2015 BASELL POLIOLEFINE ITALIA SRL PURELL PE 3020 K
### A II 11/28/2016 STERILE INDIA PVT LTD PANTOPRAZOLE SODIUM (STERILE)
### A II 11/28/2016 STERILE INDIA PVT LTD RABEPRAZOLE SODIUM (STERILE)
### A II 11/28/2016 STERILE INDIA PVT LTD OMEPRAZOLE SODIUM (STERILE)
### A II 11/28/2016 STERILE INDIA PVT LTD CEFTRIAXONE SODIUM USP (STERILE)
### A II 11/28/2016 STERILE INDIA PVT LTD CEFUROXIME SODIUM USP (STERILE)
### A II 5/4/2018 STERILE INDIA PVT LTD AMPICILLIN SODIUM USP (STERILE)
### A II 11/28/2016 STERILE INDIA PVT LTD MEROPENEM FOR INJECTION USP
### A II 11/28/2016 STERILE INDIA PVT LTD AZITHROMYCIN (LYOPHILIZED BULK STERILE)
### A IV 11/11/2015 XINCHANG KAITAI CAPSULE CO LTD MEDICAL EMPTY CAPSULES
### A III 10/26/2015 QINGDAO HUAREN MEDICIAL PRODUCT SYNTHETIC POLYISOPRENE RUBBER CLOSURE
CO LTD FOR INJECTION USE
### A II 11/2/2015 MACCO ORGANIQUES SRO SODIUM SULFATE, USP
### A II 11/3/2015 OLON SPA GLYCOPYRRONIUM BROMIDE
Page 942
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 11/4/2015 SMS PHARMACEUTICALS LTD ARIPIPRAZOLE USP
### A II 11/4/2015 ZHEJIANG JINHUA CONBA BIO PHARM ESOMEPRAZOLE MAGNESIUM DIHYDRATE
CO LTD
### A II 11/5/2015 YALE UNIV PET CENTER [18F] FMISO
### A II 11/28/2016 STERILE INDIA PVT LTD PIPERACILLIN & TAZOBACTAM SODIUM
(STERILE)
### A II 11/28/2016 STERILE INDIA PVT LTD ACICLOVIR SODIUM (STERILE)
### A II 2/19/2016 MACLEODS PHARMACEUTICALS LTD NEBIVOLOL HYDROCHLORIDE
### A II 12/22/2015 MACLEODS PHARMACEUTICALS LTD METHIMAZOLE
### A II 11/6/2015 DIVIS LABORATORIES LTD MESALAMINE USP
### A II 3/31/2016 TARO PHARMACEUTICAL INDUSTRIES DAPSONE USP
LTD
### A II 12/6/2015 MSN LABORATORIES PRIVATE LTD TREPROSTINIL DIETHANOLAMINE [ROUTE CODE
TB]
### A II 11/13/2015 FORMOSA LABORATORIES INC COLESEVELAM HYDROCHLORIDE
### A II 11/13/2015 FORMOSA LABORATORIES INC SEVELAMER CARBONATE
### A II 12/9/2015 DAIICHI SANKYO CO LTD MAAA-1162A
### I V 12/2/2015 CLEAVE BIOSCIENCES INC NONCLINICAL INFORMATION FOR CB-5083
### I II 12/23/2015 CLEAVE BIOSCIENCES INC CB-5083 DRUG SUBSTANCE
### I II 12/23/2015 CLEAVE BIOSCIENCES INC CB-5083 CAPSULES
### A II 11/4/2015 BIZEN CHEMICAL CO LTD BIZEN EPA-E (ICOSAPENT ETHYL) DRUG
SUBSTANCE
### A II 12/3/2015 SPECGX LLC HYDROCODONE BASE (NP)
### A II 11/27/2015 MYLAN LABORATORIES LTD PEMETREXED DISODIUM HEMIPENTAHYDRATE
### A II 11/28/2015 MYLAN LABORATORIES LTD ENZALUTAMIDE
30011 A II 11/26/2015 MYLAN LABORATORIES LTD DOLUTEGRAVIR SODIUM
### A II 11/30/2015 MYLAN LABORATORIES LTD OSELTAMIVIR PHOSPHATE USP
### A II 12/24/2015 MYLAN LABORATORIES LTD TENOFOVIR ALAFENAMIDE FUMARATE
### A II 11/24/2015 FERMION OY HYDROXYCHLOROQUINE SULPHATE
### A II 12/8/2015 DR REDDYS LABORATORIES LTD LORCASERIN HYDROCHLORIDE HEMIHYDRATE
### A IV 11/9/2015 TRELYST LLC DDU-4870 SILICONE POLYMER EXCIPIENT
SYSTEM
### A III 10/30/2015 TPAC PACKAGING INDIA PRIVATE LTD PET BOTTLES FOR PHARMACEUTICALS
PACKING
### A III 11/3/2015 AMPACET CORP 192434 KOSHER FDA BLACK PE MB
### A III 11/5/2015 TOSAF COMPOUNDS LTD PACKAGING RAW MATERIALS
### A II 12/10/2015 MACLEODS PHARMACEUTICALS LTD ESOMEPRAZOLE MAGNESIUM DELAYED -
RELEASE PELLETS
### A II 12/14/2015 MACLEODS PHARMACEUTICALS LTD LANSOPRAZOLE DELAYED - RELEASE PELLETS
Page 947
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/8/2015 SHANGHAI DESANO CHEMICAL LOPINAVIR
PHARMACEUTICAL CO LTD
### A II 12/10/2015 SUNBIO INC 4-ARM POLYETHYLENE GLYCOL SUCCINIMIDYL
GLUTARATE 10,000
### A II 9/27/2016 NAVINTA LLC REMIFENTANIL HYDROCHLORIDE
### A II 1/13/2016 DSM NUTRITIONAL PRODUCTS LTD BIOTIN
### A II 12/30/2015 MINSHENG GROUP SHAOXING HOMOHARRINGTONINE
PHARMACEUTICAL CO LTD
### A V 12/8/2016 PATHEON BIOLOGICS LLC BIOTECHNOLOGY PRODUCT MANUFACTURING
IN SAINT LOUIS, MISSOURI
### A II 1/12/2016 KISSEI PHARMACEUTICALS CO LTD KLH-2109 CHOLINE DRUG SUBSTANCE
### A III 8/30/2016 ZIBO ZHONGNAN PLASTICS CO LTD PVC, PVC/PE, PET, PET/PE, PVC/PVDC SHEET
### I II 12/29/2015 CHONGQING PHARMACEUTICAL CARFILZOMIB (NON-STERILE BULK DRUG
RESEARCH INSTITUTE CO LTD SUBSTANCE)
### A III 12/24/2015 GELPAC SILICA GEL DESICCANT CANISTERS
### A II 12/29/2015 HIKMA PHARMACEUTICALS PLC NILOTINIB MONOHYDROCHLORIDE ANHYDROUS
Page 952
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A V 2/10/2016 AV PROCESSORS PVT LTD GAMMA IRRADIATION FACILITY FOR
STERILIZATION OF MEDICAL DEVICES DRUGS &
ALLIED PRODUCTS
### A IV 2/22/2016 FONA INTERNATIONAL INC 884.0554U ORANGE FLAVOR NAT & ART
### A II 2/22/2016 COVALENT LABORATORIES PRIVATE LTD CEFDINIR HYDRATE USP
### A III 3/4/2016 HOLOSTIK INDIA LTD INDUCTION SEALING WADS, HOLOGRAMS &
ALLIDE PRODUCTS
### A II 1/18/2016 HUAYI ISOTOPES CO 18F-FDG REAGENT KITS
### A II 6/4/2016 CORAL DRUGS PRIVATE LTD FORMOTEROL FUMARATE DIHYDRATE
### A II 3/28/2016 SHAANXI HANJIANG PHARMACEUTICAL MEBENDAZOLE POLYMORPH C
GROUP CO LTD
### A V 2/12/2016 AGROSURG IRRADIATORS INDIA PVT GAMMA RADIATION PROCESSING FACILITY
LTD
### A V 2/18/2016 HUAYI ISOTOPES CO NUCLEOPHILIC INTEGRATED FLUIDIC
PROCESSOR
### A IV 2/22/2016 SYMRISE AG 299761 OPTACOOL ® E
### A IV 2/2/2016 HENKEL CORP DURO-TAK 87-6913 PRESSURE SENSITIVE
ADHESIVE
### A IV 2/24/2016 DDP SPECIALTY ELECTRONIC DOW CORNING™ Q7-9330 ELASTOMER BLEND
MATERIALS US 9 LLC
### A III 5/12/2016 ORANGE PRODUCTS INC HDPE BOTTLES
### A II 3/29/2016 MSN LIFE SCIENCES PRIVATE LTD APREMILAST [ROUTE CODE LI]
### A II 3/3/2016 HETERO LABS LTD PIOGLITAZONE HYDROCHLORIDE (PROCESS-II)
### A III 2/1/2016 JIANGYIN PROPACK PACKING CO LTD ALUMINUM FOIL FOR PACKAGING OF MEDICINE
### A II 11/23/2016 SUN PHARMACEUTICAL INDUSTRIES OMEPRAZOLE MAGNESIUM USP
LTD
### A II 3/14/2016 DELMAR CHEMICALS INC APIXABAN
### A III 2/19/2016 ROLLPRINT PACKAGING PRODUCTS INC RPP# 36-1088D
Page 953
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 4/20/2016 TEVA PHARMACEUTICAL INDUSTRIES ARMODAFINIL 7SM1029
LTD
### A II 4/13/2016 LUPIN LTD PIRFENIDONE
### A II 3/22/2016 JUBILANT GENERICS LTD OLANZAPINE USP
### A II 3/30/2016 JUBILANT GENERICS LTD FEBUXOSTAT
### A II 4/7/2016 MACLEODS PHARMACEUTICALS LTD HYDRALAZINE HYDROCHLORIDE
### A II 2/20/2016 QILU ANTIBIOTICS LINYI TENOFOVIR DISOPROXIL FUMARATE
PHARMACEUTICAL CO LTD
### A III 2/4/2016 NGPL PAPER PACK PVT LTD COATED/LAMINATED-PLAIN/PRINTED-
ALUMINIUM FOILS
### A II 2/26/2016 POLYMED THERAPEUTICS INC CARFILZOMIB DRUG SUBSTANCE
### A IV 2/29/2016 DHARA LIFESCIENCE PVT LTD FILMCOAT UNIVERSAL
### A IV 2/29/2016 DHARA LIFESCIENCE PVT LTD COLONCOAT EC
### A IV 2/29/2016 DHARA LIFESCIENCE PVT LTD FILMCOAT MB
### A IV 2/29/2016 DHARA LIFESCIENCE PVT LTD FILMCOAT AMB
### A IV 2/29/2016 DHARA LIFESCIENCE PVT LTD AQUA EZE
### A IV 2/29/2016 DHARA LIFESCIENCE PVT LTD FILMCOAT SC
### A II 3/11/2016 DEBIOPHARM RESEARCH AND TRIPTORELIN PAMOATE MICROGRANULES
MANUFACTURING SA
### A II 2/3/2016 SHANGHAI DESANO CHEMICAL DOLUTEGRAVIR SODIUM
PHARMACEUTICAL CO LTD
### A II 12/31/2015 SHANGHAI DESANO CHEMICAL CANAGLIFLOZIN
PHARMACEUTICAL CO LTD
### A IV 2/29/2016 DHARA LIFESCIENCE PVT LTD COLONCOAT L100
### A IV 2/29/2016 DHARA LIFESCIENCE PVT LTD COLONCOAT L 30 D
### A IV 2/29/2016 DHARA LIFESCIENCE PVT LTD COLONCOAT S100
### A IV 2/29/2016 DHARA LIFESCIENCE PVT LTD COLONCOAT MAE 100P
### A IV 2/29/2016 DHARA LIFESCIENCE PVT LTD COLONCOAT L 100 55
### A III 3/4/2016 APPLE CONVERTING INC APPLE TDPS-C082
### A II 3/3/2016 SANOFI CHIMIE HYDROCORTISONE
### A III 3/3/2016 TRINSEO LLC MAGNUM™ MED ABS RESINS
### A II 4/15/2016 LUPIN LTD METHYLPREDNISOLONE SODIUM SUCCINATE
### A II 3/22/2016 LUPIN LTD LEVOTHYROXINE SODIUM USP
### A II 4/11/2016 LUPIN LTD TESTOSTERONE USP
### A II 4/14/2016 LUPIN LTD EZETIMIBE USP (PROCESS-C)
### A IV 3/1/2016 NICHIRIN CHEMICAL INDUSTRIES LTD E.C.G®-505
### A II 1/3/2016 SNJ LABS PVT LTD IRON SUCROSE (PYROGEN FREE)
### A II 3/29/2016 UNICHEM LABORATORIES LTD SOLIFENACIN SUCCINATE
### A II 3/22/2016 UNICHEM LABORATORIES LTD DIMETHYL FUMARATE
### A II 3/31/2016 UNICHEM LABORATORIES LTD CINACALCET HYDROCHLORIDE
### A II 3/5/2016 MELODY HEALTHCARE PVT LTD SALMETEROL XINAFOATE USP
### A III 2/24/2016 DY SORB CO LTD SILICA GEL
### A II 3/31/2016 ALEMBIC PHARMACEUTICALS LTD DULOXETINE HYDROCHLORIDE USP (DUX
PROCES)
Page 954
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 6/30/2016 TARO PHARMACEUTICAL INDUSTRIES PERAMPANEL 3/4 HYDRATE, MICRONIZED
LTD
### A II 3/30/2016 ALEMBIC PHARMACEUTICALS LTD ERLOTINIB HYDROCHLORIDE
### A II 3/2/2016 EVONIK REXIM NANNING GLYCINE
PHARMACEUTICAL CO LTD
### A II 3/2/2016 NORTHERN CALIFORNIA PET IMAGING (18F)-CP 18 POSITRON EMISSION TOMOGRAPHY
CENTERS IMAGING AGENT
### A III 2/29/2016 NUOVA OMPI SRL UNIPERSONALE EZ-FILL® CARTRIDGES
### A III 1/3/2016 METRO INDUSTRIES PRINTED/PLAIN POLY FOILS AND BLISTER FOILS
FOR PHARMACEUTICAL APPLICATIONS
### A III 3/9/2016 JW LIFE SCIENCE MEDICAL CLOSURE
### A II 3/30/2016 MSN LIFE SCIENCES PRIVATE LTD ESOMEPRAZOLE MAGNESIUM USP
(TRIHYDRATE) [ROUTE CODE 'EG']
### A II 3/29/2016 DR REDDYS LABORATORIES LTD CARFILZOMIB
### A II 3/31/2016 PIRAMAL ENTERPRISES LTD RIVAROXABAN
### A II 3/31/2016 PIRAMAL ENTERPRISES LTD DABIGATRAN ETEXILATE MESYLATE
### A II 3/31/2016 PIRAMAL ENTERPRISES LTD ARMODAFINIL
### A II 3/14/2016 IRVINE SCIENTIFIC SALES CO BALANCD® VERO (POWDER)
### A II 3/11/2016 ESCO-EUROPEAN SALT CO GMBH AND APISAL SODIUM CHLORIDE GMP GRADE
CO KG
### A II 3/30/2016 MSN LABORATORIES PRIVATE LTD POMALIDOMIDE [ROUTE CODE "PO"]
### A II 6/2/2016 PRAXAIR RARE GASES AND HELIUM XENON GAS FOR INHALATION, FOR CLINICAL
TRIALS
### A IV 5/19/2016 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET 10275375-7]
30411 A IV 2/28/2016 MB SUGARS AND PHARMACEUTICALS MICROCRYSTALLINE CELLULOSE PELLETS
LTD
### A II 3/16/2016 HETERO LABS LTD OSELTAMIVIR PHOSPHATE
### I II 6/2/2016 DR REDDYS LABORATORIES LTD MIRABEGRON PREMIX
### A II 3/29/2016 EMCURE PHARMACEUTICALS LTD TERIFLUNOMIDE
### A II 3/31/2016 EMCURE PHARMACEUTICALS LTD PALIPERIDONE USP
### A IV 4/25/2016 FMC CORP NUTRICOL® PH 0111 KONJAC GLUCOMANNAN
### A II 9/26/2016 CIPLA LTD FLUTICASONE PROPIONATE USP (PROCESS II)
### A IV 3/14/2016 UNGERER AND CO ART BUTTERSCOTCH FL FZ-1661
### A II 3/18/2016 ROVI CONTRACT MANUFACTURING SL STERILE WATER FOR INJECTION 2.2ML
PREFILLED SYRINGE
### A II 3/30/2016 MAITHRI DRUGS PRIVATE LTD EFINACONAZOLE [ROUTE CODE 'EC']
### A II 3/29/2016 MSN LIFE SCIENCES PRIVATE LTD LINACLOTIDE [ROUTE CODE LE]
### A II 3/31/2016 MAITHRI DRUGS PRIVATE LTD TIGECYCLINE USP (FORM-II) [ROUTE CODE 'TY']
### A II 3/31/2016 MSN PHARMACHEM PRIVATE LTD RILPIVIRINE HYDROCHLORIDE [ROUTE CODE
RC]
### A II 3/31/2016 MSN LABORATORIES PRIVATE LTD THIOTEPA USP [ROUTE CODE "ZT"]
### A II 3/21/2016 OLON SPA DAUNORUBICIN HYDROCHLORIDE
### A II 4/1/2016 CADILA HEALTHCARE LTD TERIFLUNOMIDE
### A III 3/18/2016 ORGANIC INDUSTRIES PVT LTD PET BOTTLES
### A III 3/18/2016 ORGANIC INDUSTRIES PVT LTD HDPE CONTAINERS
Page 955
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 9/16/2016 AMPHASTAR NANJING PROTAMINE SULFATE USP
PHARMACEUTICALS INC (ANP) AN
AMPHASTAR CO
### A II 5/5/2016 BASILDON CHEMICAL CO LTD SIMETHICONE EMULSION USP (BC
SIMETHICONE ANTIFOAM PD30S)
### A II 3/17/2016 BACHEM AMERICAS INC SINCALIDE
### A III 3/18/2016 ROLLPRINT PACKAGING PRODUCTS INC RPP# 37-1274
Page 958
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 4/8/2016 SHENG ZOU PHARMACEUTICAL SHENG ZOU FORMULATION K03(K03B) RUBBER
PACKAGING & DEVICE TECHNOLOGY STOPPER
(CHINA) CO., LTD.
### A II 9/27/2016 BIOPHORE INDIA PHARMACEUTICALS ICATIBANT ACETATE
PVT LTD
### A II 6/2/2016 CADILA HEALTHCARE LTD PERAMPANEL
### A III 4/29/2016 DYNIC USA CORP HF24 WHITE THERMAL TRANSFER RIBBON
### A II 5/23/2016 OTSUKA PHARMACEUTICAL CO LTD OPA-15406 DRUG SUBSTANCE
### A III 3/18/2016 VIVEK POLYPLAST INDIA PVT LTD PLASTIC BOTTLES CONTAINERS AND
CLOSURES FOR PHARMA PACKAGING
### A II 6/4/2016 CADILA HEALTHCARE LTD TOFACITINIB CITRATE
### A III 4/29/2016 DYNIC USA CORP HF24 SILVER THERMAL TRANSFER RIBBON
### A III 5/3/2016 ROLLPRINT PACKAGING PRODUCTS INC RPP# 36-3209 & RPP# 36-33210 & RPP# 36-3210A
Page 961
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 6/9/2016 FONA INTERNATIONAL INC 915.2224U STRAWBERRY CHEESECAKE
FLAVOR NAT & ART
### A IV 6/9/2016 FONA INTERNATIONAL INC 826.2208U CHOCOLATE FLAVOR, NAT & ART
### A IV 6/8/2016 FONA INTERNATIONAL INC 822.0251U CARAMEL FLAVOR, NAT WONF
### A II 6/29/2016 DSM NUTRITIONAL PRODUCTS LTD THIAMINE HYDROCHLORIDE
### I II 7/29/2016 WATSON PHARMA PRIVATE LTD APIXABAN
### A II 7/30/2016 HETERO LABS LTD LOPINAVIR (PROCESS-II)
### A III 6/3/2016 AMPACET CORP 4600891-N BLUE SMC PP MB
### A II 6/30/2016 AMRI RENSSELAER INC CANNABIDIOL DRUG SUBSTANCE
### A III 6/3/2016 JIANGSU RUNQI NEW MATERIALS CO PA/AL/PVC COLD-FORMED FOIL FOR
LTD PHARMACEUTICAL PACKAGING
### A II 6/21/2016 ASYMCHEM LABORATORIES TIANJIN CO TOREMIFENE CITRATE
LTD
### A IV 6/10/2016 UNGERER AND CO ARTIFICIAL TUTTI FRUITTI FLVP FT-5103
### A IV 6/10/2016 UNGERER AND CO NATURAL/ARTIFICIAL BERRY FLAVOR FY-6884
### A IV 6/10/2016 UNGERER AND CO NATURAL/ARTIFICIAL ORANGE EXTRACT
FLAVOR FZ-4297
### A II 7/9/2016 SCINOPHARM TAIWAN LTD ENZALUTAMIDE
### A III 7/12/2016 SIBO G DOO CHILD RESISTANT CLOSURES SIBO
### A II 6/30/2016 MEDICHEM MANUFACTURING MALTA APIXABAN
LTD
### A III 6/16/2016 DOCTORPACK INDIA PVT LTD ORAL DOSING SYRINGE
### A III 6/2/2016 JIANGSU HANLIN PHARMACEUTICAL POLYAMIDE/ALUMINUM/PVC SOLID MEDICINAL
PACKAGE TECHNOLOGY CO LTD COMPOSITE PLATE
### A II 6/24/2016 INTAS PHARMACEUTICALS LTD PERAMPANEL
### A II 7/2/2016 MSN LIFE SCIENCES PRIVATE LTD COBICISTAT ON SILICON DIOXIDE
### A II 7/5/2016 DSM NUTRITIONAL PRODUCTS LTD FOLIC ACID
### A II 9/15/2016 CHEMWERTH INC ISOPROTERENOL HCL USP
### A II 6/28/2016 SINTENOVO SA DE CV APIXABAN
### A II 7/5/2016 UNICHEM LABORATORIES LTD TOFACITINIB CITRATE
### A III 6/17/2016 DOCTORPACK INDIA PVT LTD COP/COC/PP/HDPE VIAL
### A III 6/21/2016 WAKOL GMBH WAKOL D 3990 SEALING COMPOUND (100) /
WAKOL D 3992 SEALING COMPOUND (102 LV)
### A II 10/7/2016 SPECGX LLC DEXMETHYLPHENIDATE HYDROCHLORIDE
### A II 9/27/2016 NATIONAL CENTER FOR NATURAL CANNABIDIOL
PRODUCTS RESEARCH
### A III 6/14/2016 SICHUAN HUILI INDUSTRY CO LTD PVC/ACLAR/PVC COMPOSITE SHEET FOR
PACKAGING OF SOLID DOSAGE FORMS
### A III 6/14/2016 SICHUAN HUILI INDUSTRY CO LTD PAPER/PET/AL COMPOSITE SHEET FOR
PACKAGING OF SOLID DOSAGE FORMS
### A III 6/14/2016 SICHUAN HUILI INDUSTRY CO LTD PAPER/AL COMPOSITE SHEET FOR PACKAGING
OF SOLID DOSAGE FORMS
### A IV 6/21/2016 FONA INTERNATIONAL INC 807.0787U MIXED BERRY FLAVOR NAT WONF
### A II 6/28/2016 DR REDDYS LABORATORIES LTD PREGABALIN USP
Page 962
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 6/21/2016 FONA INTERNATIONAL INC 856.0307U CONCORD GRAPE FLAVOR, NAT &
ART
### A IV 6/17/2016 FONA INTERNATIONAL INC 852.0108U FRUIT PUNCH FLAVOR NAT & ART
### A IV 6/21/2016 FONA INTERNATIONAL INC 932.0032U N-C WINTERGREEN FLAVOR NAT
WONF
### A II 7/20/2016 UNION QUIMICO FARMACEUTICA SA ESOMEPRAZOLE SODIUM
(UQUIFA SA)
### A II 7/14/2016 HETERO LABS LTD POMALIDOMIDE
### A III 6/23/2016 MITSUBISHI GAS CHEMICAL CO INC OXYCAPT™ VIALS FOR PHARMACEUTICAL USE
### A III 5/4/2016 SANTAPET POLYMERS LTD INJECTION BLOW MOULDED BOTTLES FOR EYE
DROPPERS, NASAL SPRAYERS AND TABLETS
CONTAINERS FOR PHARMACEUTICALS
Page 966
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 10/27/2016 RAKS PHARMA PVT LTD VARDENAFIL HYDROCHLORIDE TRIHYDRATE
USP
### A III 8/4/2016 ARAB MEDICAL CONTAINERS CO LTD 28MM HDPE PACKAGING SYSTEM
### A II 9/27/2016 NOVUGEN PHARMA (MALAYSIA) SDN MIDODRINE HYDROCHLORIDE USP
BHD
### A III 9/12/2016 CORNING INC PHARMACEUTICAL GLASS CONTAINERS
### A III 7/29/2016 AMPACET CORP 1602313-N TRANS BLUE SMC PE MB
### A II 7/13/2017 SARACA LABORATORIES LTD GABAPENTIN USP
### A II 8/30/2016 APOTEX PHARMACHEM INDIA PVT LTD PERINDOPRIL ARGININE
30811 A II 8/13/2016 BIOPHORE INDIA PHARMACEUTICALS ISOPROTERENOL HYDROCHLORIDE
PVT LTD
### A III 8/1/2016 INEOS STYROLUTION GROUP GMBH ZYLAR® RESINS
### A II 9/19/2016 BIOPHORE INDIA PHARMACEUTICALS ETHACRYNATE SODIUM
PVT LTD
### A II 8/20/2016 BIOPHORE INDIA PHARMACEUTICALS CLOMIPRAMINE HYDROCHLORIDE
PVT LTD
### A II 8/2/2016 ANTIBIOTICOS DE LEON SLU AMPICILLIN TRIHYDRATE
### A III 9/26/2016 SANOK RUBBER CO SA RUBBER STOPPER LK-6/1/E AND LK-16
### A II 9/20/2016 CIPLA LTD DEFERASIROX
### A IV 8/5/2016 FONA INTERNATIONAL INC 819.0029U BUTTERSCOTCH FLAVOR NAT & ART
Page 967
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 7/18/2016 STERLING BIOTECH LTD SIMVASTATIN AMMONIUM SALT DRUG
SUBSTANCE INTERMEDIATE
### A II 7/20/2016 STERLING BIOTECH LTD SIMVASTATIN USP
### A III 8/3/2016 ROLLPRINT PACKAGING PRODUCTS INC RPP#37-1249
### A IV 8/11/2016 FONA INTERNATIONAL INC 822.0418U N-C CARAMEL FLAVOR NAT & ART
### A IV 8/11/2016 FONA INTERNATIONAL INC 936.1204U FONATECH® TASTE MODIFIER
FLAVOR NAT
### A IV 8/11/2016 FONA INTERNATIONAL INC 936.0504U BITTERNESS MASKING FLAVOR NAT
### A IV 8/9/2016 FONA INTERNATIONAL INC 805.0092U N-C BANANA FLAVOR NAT
### A II 8/2/2016 LIFE TECHNOLOGIES LTD INCHINNAN AGT MEDIA
### A II 9/30/2016 NATCO PHARMA LTD APIXABAN
### A IV 8/16/2016 GELCAPS INDUSTRIES EMPTY HARD GELATIN CAPSULES
### A II 8/18/2016 ZHEJIANG HUAHAI PHARMACEUTICAL NEBIVOLOL HYDROCHLORIDE
CO LTD
### A II 9/13/2016 APICORE US LLC SODIUM NITROPRUSSIDE USP
### A II 9/7/2016 NEULAND LABORATORIES LTD MIRTAZAPINE USP (ACETONE ROUTE)
### A III 7/27/2016 APPLE CONVERTING INC APPLE TDPS C086
### A II 9/9/2016 CORAL DRUGS PRIVATE LTD MOMETASONE FUROATE
### A II 8/19/2016 CHONGQING PHARMACEUTICAL CANAGLIFLOZIN MONOHYDRATE (NON-STERILE
RESEARCH INSTITUTE CO LTD BULK DRUG SUBSTANCE)
### A III 8/19/2016 ENVASES COMERCIALES ENVASA SA INJECTION-BLOW MOLDING BOTTLES (IBM) AND
CAPS
### A IV 8/18/2016 FONA INTERNATIONAL INC 926.2128U N-C COOL VANILLA FLAVOR NAT &
ART
### A III 8/17/2016 INNOVAPLAST SA DE CV STICKS PLASTICS BOTTLE
### A II 9/22/2016 HONOUR LAB LTD SITAGLIPTIN PHOSPHATE MONOHYDRATE
### A II 10/17/2016 HONOUR LAB LTD OSPEMIFENE
### A II 10/14/2016 JIANGSU HANSYN PHARMACEUTICAL POSACONAZOLE FORM I
CO LTD
### A II 9/5/2016 QILU TIANHE PHARMACEUTICAL CO LTD TADALAFIL
### A II 9/27/2016 ESJAY PHARMA LLC TREPROSTINIL SODIUM
### A II 9/12/2016 ESJAY PHARMA LLC CHLORZOXAZONE USP
### A II 9/30/2016 MICRO LABS LTD DIMETHYL FUMARATE
### A II 10/27/2016 CIPLA LTD DONEPEZIL HYDROCHLORIDE USP
(ANHYDROUS)
### A II 8/31/2016 MSN LIFE SCIENCES PRIVATE LTD APREMILAST (FORM-M)
### A III 8/27/2016 PRINTMANN FOILS HSL COATED, LAMINATED & PRINTED
ALUMINIUM FOILS
### A II 9/19/2016 ALEMBIC PHARMACEUTICALS LTD GEFITINIB
### A IV 11/17/2016 HONEYWELL INTERNATIONAL INC SOLSTICE® PROPELLANT HP (HFO-1234ZE HP)
### A III 11/17/2016 MEDINSTILL DEVELOPMENT LLC MEDINSTILL INTACT™ CONNECTORS
### A II 9/30/2016 CADILA HEALTHCARE LTD IMATINIB MESYLATE
Page 968
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 5/30/2017 JOHNSON MATTHEY PHARMA SERVICES 4314.B
### A II 8/31/2016 HEC PHARM CO LTD APIXABAN NON-STERILE BULK DRUG
SUBSTANCE
### A II 9/2/2016 MSN LIFE SCIENCES PRIVATE LTD CLOBAZAM
### A II 9/6/2016 MSN LABORATORIES PRIVATE LTD PLERIXAFOR
### A II 11/8/2016 ESJAY PHARMA LLC TRIENTINE HYDROCHLORIDE USP
### A II 9/20/2016 ZHEJIANG HUAHAI PHARMACEUTICAL CANAGLIFLOZIN
CO LTD
### A II 9/30/2016 BIOCON LTD MICAFUNGIN SODIUM
### A II 10/27/2016 POLYPEPTIDE LABORATORIES SWEDEN DESLORELIN ACETATE
AB
### A II 10/5/2016 MSN LIFE SCIENCES PRIVATE LTD DARUNAVIR (AMORPHOUS)
### A II 9/1/2016 EVOLV LLC EVOLV E-LIQUID
### A II 8/29/2016 INTAS PHARMACEUTICALS LTD ERLOTINIB HYDROCHLORIDE
### A II 9/30/2016 BRIGHTGENE BIOMEDICAL POSACONAZOLE CRYSTALLINE III
TECHNOLOGY CO LTD
### A II 12/29/2016 SHANGHAI SHYNDEC AZITHROMYCIN DIHYDRATE
PHARMACEUTICAL HAIMEN CO LTD
### A III 8/24/2016 SAINT GOBAIN PERFORMANCE PET C/1/S WITH 7819 SILICONE RELEASE
PLASTICS COATING
### A II 8/22/2016 NEWGEN BIOTECH (NINGBO) LACTASE USP
### A II 10/7/2016 ABBVIE STEMCENTRX LLC A WHOLLY SC-LD003
OWNED SUB OF ABBVIE INC
### A II 9/21/2016 MSN LIFE SCIENCES PRIVATE LTD LEVOMILNACIPRAN HYDROCHLORIDE
### A II 9/30/2016 GLENMARK PHARMACEUTICALS LTD EFINACONAZOLE
### A III 8/29/2016 SAGAR RUBBER PRODUCTS PVT LTD BLOOD COLLECTION STOPPER
### A II 8/24/2016 NOF CORP 2,3-BIS(METHYLPOLYOXYETHYLENE-OXY)-1-{[3-
(3-MALEIMIDO-1-
OXOPROPYL)AMINO]PROPYLOXY} PROPANE
(MW 60,000)
### A III 8/10/2016 AMPACET CORP 103429 PERMSTAT 429 MB
### A II 8/29/2016 ROQUETTE FRERES HYDROXYPROPYL BETADEX
### A III 8/30/2016 LINHARDT GMBH AND CO KG LAMINATED TUBES
### A III 8/25/2016 DOCTORPACK INDIA PVT LTD VETERINARY SYRINGE
### A II 12/9/2016 G AND A ASSOCS LLC SODIUM TETRADECYL SULFATE
### A II 9/15/2016 ZHEJIANG YONGTAI PHARMACEUTICAL ESOMEPRAZOLE MAGNESIUM USP, NON-
CO LTD STERILE, BULK DRUG SUBSTANCE
### A III 12/28/2016 MYLAN TECHNOLOGIES INC MEDIDERM 3105
### A III 7/21/2016 MRK PACKAGING ALUMINIUM COLLAPSIBLE TUBES
### A V 10/24/2016 WUXI APPTEC INC STERILE PROCESSING FACILITY
### A II 9/15/2016 NAVINTA LLC TRIENTINE HYDROCHLORIDE USP
### A II 8/22/2016 SYMBIOTICA SPECIALITY INGREDIENTS HALOBETASOL PROPIONATE
SDN BHD
### A III 8/23/2016 SHANDONG PHARMACEUTICAL GLASS INJECTABLE GLASS CONTAINERS MADE OF
CO LTD BOROSILICATE GLASS TUBING
Page 969
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 8/25/2016 AMPACET CORP 4600965-NF FL PURPLE SMC PP MB
### A III 8/30/2016 DOCTORPACK INDIA PVT LTD VAGINAL APPLICATOR
### A II 9/20/2016 NAVINTA LLC PHYTONADIONE USP (PROCESS A)
30911 A II 8/23/2016 HEBEI WORLDSTAR CHEMICAL CO LTD 4AA (4-ACETOXYAZETIDIN-2-ONE)
### A II 8/23/2016 HEBEI WORLDSTAR CHEMICAL CO LTD MAP (BETA-METHYL VINYL PHOSPHATE)
### A II 9/30/2016 HEC PHARM CO LTD ALOGLIPTIN BENZOATE NON-STERILE BULK
DRUG SUBSTANCE
### A II 11/10/2016 TIANJIN WEIJIE PHARMACEUTICAL CO DIETHYLSTILBESTROL
LTD
### A IV 9/1/2016 ABELEI INC 160A04 NAT & ART JUICY LEMON FLAVOR
### A IV 9/1/2016 ABELEI INC 151A39 NATURAL HONEY FLAVOR WONF
### A III 9/7/2016 SINOPEC ASSETS MANAGEMENT CORP STYRENE BLOCK POLYMERS WITH 1 3
BALING PETROCHEMICAL BRANCH BUTADIENE HYDROGENATED
### A IV 9/2/2016 FONA INTERNATIONAL INC 856.2124U GRAPE FLAVOR NAT & ART
### A II 8/25/2016 NINGBO GREEN HEALTH 10-DAB
PHARMACEUTICAL CO LTD
### A III 11/16/2016 ECLATIN AG INTERNAL LACQUER AO-A2263/S3HS
MONOCOMPONENT BPA FREE
### A III 3/8/2017 ECLATIN AG INTERNAL LACQUER BO-A2263/S2B BPA FREE
### A II 9/30/2016 GRANULES INDIA LTD PIRFENIDONE
### A III 9/16/2016 MANJUSHREE TECHNOPACK LTD PET & HDPE BOTTLES
### A II 9/28/2016 POLYPEPTIDE LABORATORIES SWEDEN EXENATIDE USP
AB
### A II 12/23/2016 SCINOPHARM TAIWAN LTD IBRUTINIB
### A II 10/27/2016 SCINOPHARM TAIWAN LTD CELECOXIB USP
### A II 12/31/2016 FRESENIUS KABI ONCOLOGY LTD AFATINIB DIMALEATE
### A II 9/15/2016 AUROBINDO PHARMA LTD DIMETHYL FUMARATE
### A II 9/16/2016 UNICHEM LABORATORIES LTD APIXABAN
### A II 10/20/2016 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET-10258867]
### A IV 9/8/2016 DAH FENG CAPSULE INDUSTRY CO LTD EMPTY HARD SHELL ACID RESISTANT
VEGETABLE CAPSULES (HYDROXYPROPYL
METHYL CELLULOSE)
### A II 12/1/2016 LEK PHARMACEUTICALS DD ROSUVASTATIN CALCIUM (PROCESS C)
### A II 12/19/2016 LEK PHARMACEUTICALS DD DOLUTEGRAVIR SODIUM
### A II 9/29/2016 LAURUS LABS LTD ATAZANAVIR SULFATE
### A II 9/28/2016 LAURUS LABS LTD DOLUTEGRAVIR SODIUM
### A II 9/29/2016 TEVA PHARMACEUTICAL INDUSTRIES DIMETHYL FUMARATE
LTD
### A III 9/7/2016 LOPAREX LLC POLYESTER ( PET ) LINER
### A II 9/27/2016 GRANULES INDIA LTD DIMETHYL FUMARATE
### A II 3/23/2017 TARO PHARMACEUTICAL INDUSTRIES TERBINAFINE HYDROCHLORIDE , USP
LTD
### A II 9/16/2016 ALKEM LABORATORIES LTD CANAGLIFLOZIN
### A II 9/30/2016 AZICO BIOPHORE INDIA PVT LTD LIOTHYRONINE SODIUM
Page 970
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 2/28/2017 JOHNSON MATTHEY PHARMACEUTICAL B1486
MATERIALS
### A II 9/20/2016 ZHEJIANG HUAHAI PHARMACEUTICAL DIMETHYL FUMARATE (PROCESS II)
CO LTD
### A III 9/2/2016 AMPACET CORP 4600998 N FL PURPLE SMC PP MB
### A III 9/2/2016 AMPACET CORP 4300364 N YELLOW SMC PP MB
### A II 8/29/2016 RIOCARE INDIA PRIVATE LTD SIMETHICONE USP
### A II 8/29/2016 RIOCARE INDIA PRIVATE LTD SIMETHICONE EMULSION USP
### A II 8/29/2016 RIOCARE INDIA PRIVATE LTD DIMETHICONE USP
### A II 10/18/2016 INDOCO REMEDIES LTD CANAGLIFLOZIN
### A II 9/20/2016 SHILPA MEDICARE LTD PIRFENIDONE
### A II 10/18/2016 APICORE US LLC POMALIDOMIDE
### A II 9/28/2016 HEC PHARM CO LTD ARIPIPRAZOLE NON-STERILE BULK DRUG
SUBSTANCE
### A II 10/19/2016 WOCKHARDT BIO AG PALONOSETRON HYDROCHLORIDE USP
### A III 9/1/2016 INEOS STYROLUTION GROUP GMBH STYROLUX® 3G46
### A II 6/30/2017 DIPHARMA FRANCIS SRL SELEGILINE BASE
### A II 10/20/2016 ZHEJIANG HUAHAI PHARMACEUTICAL EFAVIRENZ USP
CO LTD
### A II 9/21/2016 HETERO LABS LTD IMATINIB MESYLATE (FORM-B)
### A II 11/16/2016 HELSINN THERAPEUTICS US INC ANAMORELIN HYDROCHLORIDE, 100 MG
TABLETS
### A II 9/10/2016 VITAL LABORATORIES PVT LTD METHSCOPOLAMINE BROMIDE
### A III 9/8/2016 ROLLPRINT PACKAGING PRODUCTS INC RPP# 36-1011B
Page 978
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 1/16/2017 EVONIK CORP BIODEGRADABLE POLYESTER-POLYETHER
BLOCK COPOLYMER EXCIPIENTS
### A II 6/29/2017 NEON THERAPEUTICS PERSONALIZED PEPTIDES
### A II 12/31/2016 MSN LABORATORIES PRIVATE LTD SALMETEROL XINAFOATE USP
### A II 12/30/2016 MSN LIFE SCIENCES PRIVATE LTD DOLUTEGRAVIR SODIUM
### A II 2/3/2017 CHATTEM CHEMICALS INC DEXTROAMPHETAMINE SULFATE USP
### A II 1/2/2017 EVONIK REXIM SAS L-ORNITHINE PHENYLACETATE
### A III 12/2/2016 AMPACET CORP 4300435-NQ YELLOW SMC AO PP MB
### A III 12/5/2016 JIANGSU CHIYUE MEDICINAL POLYAMIDE/ALUMINUM/POLYVINYL CHLORIDE
PACKAGING CO LTD ( BOPA/ AL/PVC) COLD FORMING COMPOSITE
SHEET FOR PACKAGING OF SOLID DOSAGE
FORMS
### I II 12/18/2016 WISDOM PHARMACEUTICAL CO LTD ENTECAVIR INTERMEDIATE
### A II 1/27/2017 NOVITIUM PHARMA LLC DIAZOXIDE USP
### A II 1/2/2017 NOVITIUM PHARMA LLC NITISINONE
### A III 12/21/2016 JIANGSU OUK PACKAGING OXYGEN ABSORBER
TECHNOLOGY CO LTD
### A III 12/5/2016 JIANGSU CHIYUE MEDICINAL ALUMINUM FOIL PACKAGING MATERIALS
PACKAGING CO LTD
### A III 12/5/2016 AMPACET CORP 174385 LT GREEN PE MB
### A III 12/20/2016 SHREE NAINA PACKWELL GLASS AMPOULES AND VIALS & DENTAL
CARTRIDGE
### A II 12/21/2016 ZHEJIANG HUAHAI PHARMACEUTICAL CLOFAZIMINE USP
CO LTD
### A II 12/30/2016 MYLAN LABORATORIES LTD ARIPIPRAZOLE MONOHYDRATE
### A II 12/14/2016 AMINO GMBH L -LEUCINE FROM FERMENTATION
### A III 7/12/2016 KLASSPACK PVT LTD NEUTRAL GLASS TUBULAR VIALS
### A II 12/29/2016 MYLAN LABORATORIES LTD ICATIBANT ACETATE
### A III 12/29/2016 ISOFLEX PACKAGING POLYMER FILMS FOR PHARMACEUTICAL
APPLICATIONS
### A II 1/2/2017 SUN PHARMACEUTICAL INDUSTRIES SODIUM NITROPRUSSIDE USP
LTD
### A II 12/31/2016 MSN LIFE SCIENCES PRIVATE LTD SODIUM PHENYLACETATE
### A II 12/31/2016 MSN LIFE SCIENCES PRIVATE LTD PIRFENIDONE
### A II 12/30/2016 AUROBINDO PHARMA LTD DRONEDARONE HYDROCHLORIDE USP
### A II 3/22/2017 LUPIN LTD APREMILAST (FORM M)
### A II 12/15/2016 INNOVATIVE PHARMACY SOLUTIONS PEMOLINE 18.75 MG COMPOUNDED CAPSULES
LLC
### A II 12/12/2016 IRVINE SCIENTIFIC SALES CO INC BALANCD® HEK293 (POWDER)
### A II 1/9/2017 ZHEJIANG HUAHAI PHARMACEUTICAL DAPAGLIFLOZIN PROPANEDIOL
CO LTD
### A II 12/30/2016 MYLAN LABORATORIES LTD SACUBITRIL
### A II 9/1/2017 MYLAN LABORATORIES LTD SOFOSBUVIR
### A II 12/31/2016 MYLAN LABORATORIES LTD PIRFENIDONE
### A II 1/31/2017 APOTEX PHARMACHEM INC LUBIPROSTONE
Page 979
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 12/30/2016 CHUNGHWA CHEMICAL SYNTHESIS AND CARFILZOMIB
BIOTECH CO LTD
### A II 12/16/2016 CHEMICAL AND BIOPHARMACEUTICAL OCTREOTIDE ACETATE
LABORATORIES OF PATRAS SA (CBL
PATRAS SA)
### A II 12/20/2016 ALCHEM INTERNATIONAL PRIVATE LTD ATROPINE SULFATE USP
### I III 12/12/2016 AMPACET CORP 4700157 N TEAL PP MB
### A III 12/27/2016 KUNSHAN WISEPAC DESICCANT CO LTD SILICA GEL DESICCANT WITH AIHUA PAPER
### A III 1/31/2017 TRUDELL MEDICAL INTERNATIONAL TOP MOUNT ACTUATION INDICATOR TMAI200
PLATFORM
Page 981
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 1/5/2017 POLYONE CORP TP09990846xx
### A III 12/16/2016 ACHYUT PACKAGING PVT LTD LAMINATED COATED PRINTED & PLAIN BLISTER
FOIL STRIP FOIL ALU ALU COLD FORM FOIL CR
FOIL LIDDING FOIL PVC/PVDC COATED PVC FILM
GLASSINE PAPER ( COATED/LAMINATED)
LAMINATES POUCHES/TETRAPACK TAGGERS
WADS AND FLEXIBLE PACKAGING FOR
PHARMACEUTICAL AS WELL AS FOOD
PACKAGING INDUSTRIES
Page 984
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 2/28/2017 GLOBAL ISOTOPES LLC DBA ZEVACOR STRONTIUM CHLORIDE (SR-82) API STARTING
MOLECULAR MATERIAL
### A IV 2/8/2017 SYMRISE AG 769441 CHERRY FLAVOR SD
### A IV 2/8/2017 SYMRISE AG 746600 ORANGE FLAVOR
### A IV 2/8/2017 SYMRISE AG 652742 RASPBERRY FLAVOR SD
### A IV 2/8/2017 SYMRISE AG 746603 ORANGE FLAVOR
### A IV 2/8/2017 SYMRISE AG 769472 STRAWBERRY FLAVOR SD
### A II 2/14/2017 HVIVO HUMAN RHINOVIRUS STRAIN 16 (HRV-16) DRUG
SUBSTANCE
### A IV 2/8/2017 SYMRISE AG 290012 BLACK CURRANT FLAVOR SD
### A III 1/23/2017 NINGBO ZHENGLI PHARMACEUTICAL PREFILLABLE GLASS SYRINGES
PACKAGING CO LTD
### A II 2/7/2017 QIDONG DONGYUE PHARMACEUTICAL 3-(4-PHENOXYPHENYL)-1H-PYRAZOLO[3,4-D]
CO LTD PYRIMIDIN-4-AMINE
### A III 1/27/2017 RAINBOW PLASTICS INDIA LTD COATED/PLAIN/PRINTED/LAMINATED
ALUMINIUM FOIL, GLASSINE PAPER,
PRINTED/PLAIN ALU- ALU FOIL, PRINTED/PLAIN
CHILD RESISTANT FOIL (CR FOIL),
COATED/PLAIN/PRINTED WADS AND TAGGERS,
VCACUUM/THERMO FORMED CONTAINERS AND
FLEXIBLE PACKAGING
### A II 3/3/2017 BRIGHTGENE BIOMEDICAL MICAFUNGIN SODIUM (NON-STERILE, API)
TECHNOLOGY CO LTD
### A II 2/28/2017 MSN LABORATORIES PRIVATE LTD TREPROSTINIL SODIUM
### A II 2/28/2017 ALEMBIC PHARMACEUTICALS LTD ERYTHROMYCIN ETHYLSUCCINATE USP
### A II 3/30/2017 ALEMBIC PHARMACEUTICALS LTD LINAGLIPTIN
### A II 3/1/2017 SUN PHARMACEUTICAL INDUSTRIES METOPROLOL SUCCINATE USP
LTD
### A II 2/22/2017 MAITHRI DRUGS PRIVATE LTD LOMITAPIDE MESYLATE (FORM-M)
### A II 3/4/2017 HETERO LABS LTD ARIPIPRAZOLE PROCESS-I
### A III 3/3/2017 SUNPLAST PE BOTTLES AND PP CLOSURES FOR
PHARMACEUTICAL PACKAGING
### A II 3/10/2017 MYLAN LABORATORIES LTD EMTRICITABINE (PROCESS-III)
### A II 3/31/2017 BACHEM AG BIVALIRUDIN
### A II 3/31/2017 MICRO LABS LTD SOLIFENACIN SUCCINATE
### A II 5/3/2017 ZHEJIANG HUAHAI PHARMACEUTICAL TENOFOVIR DISOPROXIL FUMARATE
CO LTD
### A II 3/7/2017 NINGXIA TAIYICIN BIOTECH CO LTD LINCOMYCIN HYDROCHLORIDE
### A II 4/1/2017 CADILA HEALTHCARE LTD MACITENTAN
### A II 2/17/2017 QINGDAO WANTUMING BIOLOGICAL CO CHONDROITIN SULFATE SODIUM
LTD
### A II 3/5/2018 ZHEJIANG RUIBANG LABORATORIES CYCLOSPORINE CRUDE
### A IV 3/8/2017 APOTEX PHARMACHEM INC POLYQUATERNIUM-1
### A III 2/16/2017 ADHESIVES RESEARCH INC A 3161 (AS 121 ADHESIVE)
### A III 2/16/2017 ADHESIVES RESEARCH INC A4397 (MA-78)
Page 985
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 2/16/2017 NEMERA NEUENBURG GMBH PRE METERED DRY POWDER INHALER
COMPONENTS
### A II 3/16/2017 AUROBINDO PHARMA LTD FOSAPREPITANT DIMEGLUMINE
### A II 2/3/2017 JOHANNES BURGER YSATFABRIK GMBH DRY EXTRACT OF COLCHICUM AUTUMNALE
SEEDS (MEADOW SAFFRON SEEDS)
### A II 4/13/2017 LUPIN LTD DOLUTEGRAVIR SODIUM (PROCESS A)
### A II 3/21/2017 LUPIN LTD DOLUTEGRAVIR SODIUM ( PROCESS B)
### A III 2/22/2017 ROCHLING MEDICAL NEUHAUS GMBH ROUND WIDE-NECK BOTTLE 1000ML (P 3756)
AND CO KG WITH TEMPER EVIDENT CLOSURE (HPT 7022)
### A II 3/13/2017 DR REDDYS LABORATORIES LTD ELIGLUSTAT TARTRATE
### A II 10/10/2018 CHEMWERTH INC ZIPRASIDONE MESILATE TRIHYDRATE
### A II 4/26/2017 BIOPHORE INDIA PHARMACEUTICALS AMINOCAPROIC ACID
PVT LTD
### A II 6/17/2017 BIOPHORE INDIA PHARMACEUTICALS CHLORPROMAZINE HYDROCHLORIDE
PVT LTD
### A II 4/13/2017 JIANGSU HANSOH PHARMACEUTICAL VINORELBINE TARTRATE, USP
GROUP CO LTD
### A II 3/24/2017 JIANGSU HANSOH PHARMACEUTICAL GEMCITABINE HYDROCHLORIDE USP
GROUP CO LTD
### A II 3/30/2018 TARO PHARMACEUTICAL INDUSTRIES TICAGRELOR
LTD
### A II 3/21/2017 BIOSPECTRA TROMETHAMINE
### A II 3/20/2017 PIRAMAL ENTERPRISES LTD FOSAPREPITANT DIMEGLUMINE
### A II 3/29/2017 PIRAMAL ENTERPRISES LTD DEFERASIROX
### A II 3/29/2017 PIRAMAL ENTERPRISES LTD DRONEDARONE HYDROCHLORIDE
### A IV 2/27/2017 FONA INTERNATIONAL INC 884.821 N-C ORANGE FLAVOR, NAT WONF
### A II 4/21/2017 ASTRAZENECA PHARMACEUTICALS LP GOSERELIN ACETATE
### A II 4/21/2017 ASTRAZENECA PHARMACEUTICALS LP GOSERELIN ACETATE IMPLANT
### A II 3/31/2017 GLENMARK PHARMACEUTICALS LTD APREMILAST
### A II 4/24/2017 EMCURE PHARMACEUTICALS LTD SODIUM CARBONATE MONOHYDRATE USP-NF
### A II 5/25/2017 ZHEJIANG HUAHAI PHARMACEUTICAL VORTIOXETINE HYDROBROMIDE
CO LTD
### A II 10/17/2017 LUPIN LTD RIFAXIMIN (PROCESS B)
### I II 2/24/2017 ZHEJIANG JIUZHOU PHARMACEUTICAL DARUNAVIR
CO LTD
### A II 3/8/2017 SINOPHARM WEIQIDA DEACETYL-7-AMINOCEPHALOSPORANIC ACID
PHARMACEUTICAL CO LTD
### A II 5/29/2017 BIOPHORE INDIA PHARMACEUTICALS PROCHLORPERAZINE
PVT LTD
### A II 7/3/2017 IPCA LABORATORIES LTD VENLAFAXINE HYDROCHLORIDE USP
### A II 4/15/2017 LUPIN LTD DARUNAVIR ETHANOLATE (PROCESS-B)
### A II 3/16/2017 HARMAN FINOCHEM LTD PHENOBARBITAL SODIUM USP
### A II 4/3/2017 LUPIN LTD ESLICARBAZEPINE ACETATE
### A II 4/13/2017 LUPIN LTD EMPAGLIFLOZIN
Page 986
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 2/28/2017 CHIRAL QUEST SUZHOU CO LTD (2R, 4S)-5-([1,1'-BIPHENYL]-4-YL)-4-((TERT-
BUTOXYCARBONYL)AMINO)-2-
METHYLPENTANOIC ACID
### A II 4/14/2017 LUPIN LTD EFINACONAZOLE
### A II 4/14/2017 LUPIN LTD CANAGLIFLOZIN HEMIHYDRATE
### A II 5/5/2017 GUANGZHOU HENOVCOM BIOSCIENCE CLADRIBINE DRUG SUBSTANCE
CO LTD
### A II 3/30/2017 MSN LABORATORIES PRIVATE LTD RAMELTEON
### A II 3/23/2017 LUPIN LTD VORTIOXETINE HYDROBROMIDE
### A III 2/21/2017 SPACE AGE PLASTIC INDUSTRIES DROPPER ASSEMBLY
### A III 2/20/2017 SPACE AGE PLASTIC INDUSTRIES MEASURING CUP
### A II 4/14/2017 LUPIN LTD METFORMIN HYDROCHLORIDE USP
31511 A II 4/14/2017 LUPIN LTD SOFOSBUVIR PREMIX
### A II 4/11/2017 LUPIN LTD WARFARIN POTASSIUM
### A II 4/13/2017 LUPIN LTD VARENICLINE TARTRATE
### A II 3/28/2017 MSN LIFE SCIENCES PRIVATE LTD DROXIDOPA
### A II 5/31/2017 SUN PHARMACEUTICAL INDUSTRIES AFATINIB DIMALEATE
LTD
### A II 4/14/2017 LUPIN LTD TENOFOVIR ALAFENAMIDE FUMARATE
### A II 3/27/2017 MSN LABORATORIES PRIVATE LTD SONIDEGIB DIPHOSPHATE
### A II 3/23/2017 DR REDDYS LABORATORIES LTD SODIUM BENZOATE USP
### A III 3/6/2017 SEAL AND PACK CO LTD PACKAGING MATERIALS
### A III 3/1/2017 AMPACET CORP 1701749 K GREEN 749
### A II 6/22/2017 DIPHARMA FRANCIS SRL DAPSONE
### A II 3/30/2017 MSN LABORATORIES PRIVATE LTD CABOZANTINIB (S)-MALATE
### A II 6/2/2017 HONOUR LAB LTD EMPAGLIFLOZIN
### A II 12/6/2017 TIEN TIANJIN PHARMACEUTICAL CO LTD TREPROSTINIL DIETHANOLAMINE
### A II 4/17/2017 DASAMI LAB PRIVATE LTD OXCARBAZEPINE USP
### A II 3/27/2017 MSN LABORATORIES PRIVATE LTD NINTEDANIB ESYLATE
### A II 12/13/2017 HEILONGJIANG WEIKAIER SIROLIMUS
BIOTECHNOLOGY CO LTD
### A II 4/5/2017 PANJIN TIANYUAN PHARMACEUTICALS MILK THISTLE DRY EXTRACT (ACETONE
CO LTD PROCESSED)
### A II 4/5/2017 PANJIN TIANYUAN PHARMACEUTICALS MILK THISTLE DRY EXTRACT (ETHANOL
CO LTD PROCESSED)
### A II 4/6/2017 PANJIN TIANYUAN PHARMACEUTICALS MILK THISTLE DRY EXTRACT (ETHYL ACETATE
CO LTD PROCESSED)
### A II 8/16/2018 ZAKLADY FARMACEUTYCZNE ARIPIPRAZOLE LAUROXIL
POLPHARMA SA
### A II 3/10/2017 FARMABIOS SPA DEXAMETHASONE (PH EUR/USP/JP)
### A II 3/21/2017 CORDEN PHARMA SWITZERLAND LLC 1,2 -DIMYRISTOYL-SN-GLYCERO-3-
PHOSPHOGLYCEROL SODIUM SALT (DMPG, NA)
Page 988
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 3/21/2017 AJINOMOTO HEALTH AND NUTRITION L-SERINE
NORTH AMERICA INC
### A II 3/21/2017 AJINOMOTO HEALTH AND NUTRITION L-TRYPTOPHAN
NORTH AMERICA INC
### A II 3/21/2017 AJINOMOTO HEALTH AND NUTRITION L-VALINE
NORTH AMERICA INC
### A II 3/21/2017 AJINOMOTO HEALTH AND NUTRITION L-HISTIDINE
NORTH AMERICA INC
### A II 3/21/2017 AJINOMOTO HEALTH AND NUTRITION L-HISTIDINE MONOHYDROCHLORIDE
NORTH AMERICA INC MONOHYDRATE
### A II 3/21/2017 AJINOMOTO HEALTH AND NUTRITION L-THREONINE
NORTH AMERICA INC
### A IV 3/7/2017 UNGERER AND CO NATURAL LEMON LIME FZ 9262
### A IV 3/7/2017 UNGERER AND CO NATURAL TUTTI FRUITTI FLVP FZ -3022
### A IV 3/9/2017 SICHUAN RAYBO BIOTECHNOLOGY CO GELATIN
LTD
### A II 3/21/2017 AJINOMOTO HEALTH AND NUTRITION L-SERINE (PROCESS II)
NORTH AMERICA INC
### A II 5/15/2017 EDMOND PHARMA SRL ISOPROTERENOL HYDROCHLORIDE
### A II 3/31/2017 MAITHRI DRUGS PRIVATE LTD MESALAMINE USP
### A II 3/31/2017 MSN LABORATORIES PRIVATE LTD PEMETREXED DIPOTASSIUM HEPTAHYDRATE
### A II 4/26/2017 GLAND PHARMA LTD PLERIXAFOR
### A II 3/30/2017 MSN LABORATORIES PRIVATE LTD TREPROSTINIL
### A II 8/29/2017 DR REDDYS LABORATORIES LTD SACUBITRIL/VALSARTAN
### A II 3/16/2017 SMS PHARMACEUTICALS LTD RANITIDINE HYDROCHLORIDE USP (PROCESS
-2)
### A II 3/30/2017 LEE PHARMA LTD VARENICLINE BASE ( INTERMEDIATE OF
VARENICLINE )
### A II 3/30/2017 SOLARA A PHARMA SCIENCES LTD POSACONAZOLE FORM-1
### A II 7/29/2017 SOLARA A PHARMA SCIENCES LTD ZILEUTON USP
### A II 3/17/2017 HIKAL LTD SITAGLIPTIN PHOSPHATE
### A II 4/5/2017 TIANJIN WEIJIE PHARMACEUTICAL CO BEXAROTENE
LTD
### A II 4/11/2017 TIANJIN WEIJIE PHARMACEUTICAL CO POMALIDOMIDE
LTD
### A II 4/12/2017 TIANJIN WEIJIE PHARMACEUTICAL CO ABIRATERONE ACETATE
LTD
### A II 3/31/2017 UNICHEM LABORATORIES LTD VORTIOXETINE HYDROBROMIDE
### A II 3/29/2017 UNICHEM LABORATORIES LTD LABETALOL HYDROCHLORIDE USP
### A III 3/17/2017 ROCHLING MEDICAL NEUHAUS GMBH BOTTLES SERIES FOR TABLETS - CELGENE
AND CO KG
### A III 3/14/2017 JAPAN VILENE CO LTD MEDICAL BACKING NON WOVEN PRODUCTS
(FORM II)
### A II 3/15/2017 SHANDONG LUXI PHARMACEUTICAL CO POLYMYXIN B SULFATE
LTD
Page 989
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A V 8/18/2017 PPD DEVELOPMENT LP SHARED SYSTEM RISK EVALUATION AND
MITIGATION STRATEGY (SSR) PROGRAM FOR
THE BUPRENORPHINE-CONTAINING
TRANSMUCOSAL PRODUCTS FOR OPIOID
DEPENDENCE (BTOD)
### A II 3/31/2017 MSN LABORATORIES PRIVATE LTD TRAMETINIB
### A II 3/28/2017 MSN LABORATORIES PRIVATE LTD LENALIDOMIDE
### A III 3/15/2017 TECHMER PM PTM11617 WHITE
### A III 3/14/2017 AMPACET CORP 712474-PT WHITE PET MB
### A II 3/31/2017 MSN LABORATORIES PRIVATE LTD NETUPITANT
### A II 3/31/2017 MSN LIFE SCIENCES PRIVATE LTD MONOMETHYL FUMARATE
### A II 9/27/2017 SHIN-ETSU CHEMICAL CO LTD SEAP-120G40
### A II 3/30/2018 MSN LIFE SCIENCES PRIVATE LTD VALSARTAN USP
### A II 5/8/2017 YUNG ZIP CHEMICAL IND CO LTD DEFERASIROX
### A II 4/26/2017 SAI LIFE SCIENCES LTD ETHACRYNATE SODIUM
### A II 3/16/2017 JIANGXI SYNERGY PHARMACEUTICAL RIVAROXABAN
CO LTD
### A II 3/30/2017 RAKS PHARMA PVT LTD VORTIOXETINE HYDROBROMIDE SOLVATE
### A II 4/4/2017 AVANTI POLAR LIPIDS INC CHOLESTERYL PALMITATE (730155)
### A III 3/22/2017 CONSOLIDATED BOTTLE CORP 60ML WHITE HDPE PHARMA ROUND 38/400
[011679]
### A II 4/18/2017 TEVA PHARMACEUTICAL INDUSTRIES DASATINIB MONOHYDRATE
LTD
### A III 5/15/2017 BOREALIS AG BORMED RE870MO
### A III 5/15/2017 BOREALIS AG BORMED RF825MO-12
### A III 5/16/2017 BOREALIS AG BORMED RG835MO-12
### A III 5/31/2017 BOREALIS AG BORMED RF830MO-12
### A III 3/30/2017 SHANGHAI JINZHU COLOR CO LTD MASTERBATCH
31611 A II 4/11/2017 HETERO LABS LTD AFATINIB DIMALEATE
### A II 5/11/2017 ZHEJIANG HUAHAI PHARMACEUTICAL LEVODOPA USP
CO LTD
### I II 3/25/2017 HIKAL LTD DABIGATRAN ETEXILATE MESYLATE
### A II 6/9/2017 GIP ARRONAX STRONTIUM-82 CHLORIDE SOLUTION
### A IV 3/30/2017 GRANT INDUSTRIES INC POLYSILICONE-11
### A IV 3/31/2017 SHAOXING KANGKE CAPSULE CO LTD ENTERIC COATED VACANT CAPSULES FROM
HYPROMELLOSE
### A II 4/6/2017 DIPHARMA FRANCIS SRL VORTIOXETINE HYDROBROMIDE
MONOHYDRATE
### A II 3/28/2017 NOF CORP [a-METHOXY-w-AMINOPROPYL, POLY
(OXYETHYLENE)]-BLOCK-POLY (ß-BENZYL-L
ASPARTATE)
### A II 3/24/2017 JIANGXI SYNERGY PHARMACEUTICAL TICAGRELOR
CO LTD
### A V 5/1/2017 MITIM SRL REFERENCE INFORMATION FOR STERILE
PROCESSING FACILITY- PENICILLINS
Page 990
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 4/7/2017 CENTAUR PHARMACEUTICALS PRIVATE PINDOLOL USP
LTD
### A IV 2/27/2017 FONA INTERNATIONAL INC 884.0324U N-C MANDARIN FLAVOR NAT WONF
### A IV 3/29/2017 SYMRISE INC 797438 NATURAL FLAVOR MULBERRY
### A IV 3/29/2017 SYMRISE INC 410434 EVOSPRAY NATURAL & ARTIFICIAL
EUCALYPTUS FLAVOR
### A IV 3/29/2017 SYMRISE INC 242072 ENTRAPPED NATURAL SPEARMINT
FLAVOR WL- 5264
### A II 6/16/2017 NOVITIUM PHARMA LLC PRAZOSIN HYDROCHLORIDE USP
### A II 4/20/2017 SM HERBALS PVT LTD QUININE SULPHATE USP
### A II 4/28/2017 HENAN LIHUA PHARMACEUTICAL CO METHYLPREDNISOLONE USP
LTD
### A II 6/8/2017 TEVA PHARMACEUTICAL INDUSTRIES IBRUTINIB
LTD
### A II 4/14/2017 ANQIU LUAN PHARMACEUTICAL CO LTD ACETAMINOPHEN DC90-7SD
### A IV 3/30/2017 JK SUCRALOSE INC SUCRALOSE (MICRONIZED AND NON-
MICRONIZED)
### A II 4/7/2017 ERREGIERRE SPA IMIDAZOLYL ETHANAMIDE PENTANDIOIC ACID
### A III 3/27/2017 YASH PACKAGING PLAIN/PRINTED TRANSPARENT PLASTIC
BOTTLES, INDUCTION SEALING CAPS,
MEASURING CUPS, DROPPER BOTTLE
ASSEMBLY, PVC RIGID BLISTER FILMS AND
PRINTED/ NON PRINTED/ LAMINATED
CORRUGATED BOXES FOR PHARMACEUTICAL
AND FOOD APPLICATIONS
Page 992
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 4/7/2017 UNGERER AND CO NATURAL AND ARTIFICIAL MIXED FRUIT FLVP FT
1789
### A IV 4/7/2017 UNGERER AND CO NATURAL AND ARTIFICIAL RASPBERRY FLAVOR
FZ 6963
### A II 4/7/2017 HUVEPHARMA ITALIA SRL ARTESUNATE
### A II 5/11/2017 MACLEODS PHARMACEUTICALS LTD VORTIOXETINE HYDROBROMIDE PREMIX
### A II 8/1/2017 HETERO LABS LTD IBRUTINIB (FORM-A)
### A II 5/23/2017 TOMITA PHARMACEUTICAL CO LTD CALCIUM GLUCONATE MONOHYDRATE USP
### A II 7/25/2017 SANECA PHARMACEUTICALS AS NALTREXONE
### A III 4/12/2017 SHAILY ENGINEERING PLASTICS LTD 05ML & 10ML OPHTHALMIC PACKAGING
COMPONENTS
### A II 4/14/2017 SUZHOU LIXIN PHARMACEUTICAL CO NILOTINIB HYDROCHLORIDE MONOHYDRATE
LTD
### A II 7/5/2017 MIKROCHEM SPOL SRO METHYLENE BLUE
### A IV 7/13/2017 CELANESE CANADA ULC ETHYLENE VINYL ACETATE COPOLYMER
VITALDOSE® K2568.X01
### A IV 7/14/2017 CELANESE CANADA ULC ETHYLENE VINYL ACETATE COPOLYMER,
VITALDOSE® K2569.X01
### A IV 3/30/2017 SOCIETE INDUSTRIELLE DES REFINED SESAME OIL IV-1
OLEAGINEUX
### A II 5/2/2017 MOEHS IBERICA SL CELIPROLOL HYDROCHLORIDE
### A II 4/28/2017 CENTAUR PHARMACEUTICALS PRIVATE LEVOMILNACIPRAN HYDROCHLORIDE
LTD
### A II 3/31/2017 SHANGHAI DESANO CHEMICAL TENOFOVIR ALAFENAMIDE FUMARATE
PHARMACEUTICAL CO LTD
### A II 4/21/2017 STEVE Y CHO MD [18F] FES 6 HOUR FORMULATION FOR
INJECTION
### A II 4/21/2017 SHANDONG CHENZHONG NADROPARIN CALCIUM
BIOPHARMACEUTICAL CO LTD
### A V 8/29/2017 SAMSUNG BIOLOGICS CO LTD FACILITIES AND EQUIPMENT INFORMATION FOR
SAMSUNG BIOLOGICS, LTD, CONTRACT
MANUFACTURING PLANT IN SONGDO, SOUTH
KOREA
### A II 5/2/2017 ADVANCED ACCELERATOR LUTETIUM [177 LU] TRICHLORIDE
APPLICATIONS USA INC
### A II 5/10/2017 UQUIFA MEXICO SA DE CV TELMISARTAN
### A IV 4/24/2017 FONA INTERNATIONAL INC 852.0231U FRUIT PUNCH FLAVOR, NAT
### A II 5/16/2017 ALKALOIDS CORP SCOPOLAMINE HYDROBROMIDE
### A II 6/22/2017 CHROMO LABORATORIES INDIA PRIVATE VORICONAZOLE USP
LTD
### A III 5/17/2017 CHENG FENG ENTERPRISES CO LTD PEN-9507-1 WHITE PE MASTERBATCH
31711 A III 4/21/2017 AMERICHEM INC 63808 CD1-100 WHITE
### A III 4/13/2017 CANGZHOU WEIKANG FOOD AND MEDICAL PLASTIC BOTTLE (SUCH AS MEDICAL
PHARMACEUTICAL PACKAGE CO LTD PLASTIC BOTTLE FOR SOLID & LIQUID
MEDICINE AND EYE DROPS)
Page 993
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 5/31/2017 HOVIONE FARMACIENCIA SA FLUTICASONE FUROATE INHALATION GRADE
### A IV 4/26/2017 FONA INTERNATIONAL INC 935.0152U TUTTI FRUTTI FLAVOR, ART
### A II 3/6/2017 IRE ELIT GALLIUM 68 RADIONUCLIDE GENERATOR
### A III 4/18/2017 FUJIMORI KOGYO CO LTD PLASTIC FILMS A FOR USE IN DRUG PRODUCT
CONTAINER
### A III 4/18/2017 FUJIMORI KOGYO CO LTD PLASTIC FILMS B FOR USE IN DRUG PRODUCT
CONTAINER
### A II 4/20/2017 YICHENG GOTO PHARMACEUTICALS CO ANDROSTENEDIONE
LTD
### A II 7/12/2017 CHROMO LABORATORIES INDIA PRIVATE TERBINAFINE HYDROCHLORIDE USP
LTD
### A III 5/17/2017 BESPACK CO LTD SOFT BAG BTM 100-23PP
### A II 4/28/2017 IRVINE SCIENTIFIC SALES CO BALANCD® TRANSFECTORY™ CHO (POWDER)
### A III 4/15/2017 RAJAT VINYLS PRIVATE LTD PVDC COATED RIGID PVC FILM FOR
PHARMACEUTICALS AND FOOD PACKAGING
APPLICATION
### A III 4/17/2017 YANTAI YONGSHENG PACKING POLYETHYLENE FOAM GASKET
MATERIAL CO LTD
### A III 4/24/2017 SUPERMAK FOILS PVT LTD ALUMINIUM FOIL PLAIN AND PRINTED
POLYETHYLENE LAMINATED AND HEAT SEAL
LACQUER (HSL) COATED CHILD RESISTANT
LAMINATES FOR PACKING PHARMACEUTICAL
TABLETS/CAPSULES & SOLID DOSAGE FORMS
### A II 6/1/2017 CADILA HEALTHCARE LTD VORTIOXETINE HYDROBROMIDE
### A III 4/21/2017 KRISH PHARMAPACK PRIMARY PACKAGING MATERIALS
### A II 7/3/2017 CIPLA LTD IBRUTINIB
### A II 5/1/2017 IRVINE SCIENTIFIC SALES CO PRIME-XV®T CELL CDM
### A III 4/17/2017 SHANGHAI JIA TIAN PHARMACEUTICAL ALUMINUM BOTTLE USED FOR SOLID
PACKAGING CO LTD PHARMACEUTICAL
### A III 4/17/2017 SHANGHAI JIA TIAN PHARMACEUTICAL ALUMINUM OINTMENT TUBE USED FOR
PACKAGING CO LTD PHARMACEUTICAL
### A III 4/17/2017 SHANGHAI JIA TIAN PHARMACEUTICAL PHARMACEUTICAL ALUMINUM AEROSOL CAN
PACKAGING CO LTD
### A II 5/17/2017 SAB HERBALS AND NUTRACEUTICALS CALCIUM SENNOSIDES 8%, 20%, 40% & 60%
COMPLYING WITH USP STANDARDS
### A IV 6/20/2017 EXCELLENT PHARMA CARE (INDIA) AF-COAT READYMIX POLYMERS
### A II 6/1/2017 BIOPHORE INDIA PHARMACEUTICALS NADOLOL
PVT LTD
### A II 6/28/2017 TEVA PHARMACEUTICAL INDUSTRIES SOFOSBUVIR 1213
LTD
### A II 7/4/2017 TEVA PHARMACEUTICAL INDUSTRIES SOFOSBUVIR 1613
LTD
### A II 5/17/2017 BIOIBERICA SAU HEPARIN SODIUM (PROCESS MPHP22002)
### A II 5/25/2017 FIS FABBRICA ITALIANA SINTETICI SPA ENCLOMIPHENE CITRATE
### A II 6/30/2017 FIS FABBRICA ITALIANA SINTETICI SPA NILOTINIB DIHYDROCHLORIDE DIHYDRATE
Page 994
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 4/24/2017 INEOS STYROLUTION GROUP GMBH STYROLUX® 4G60
### A II 5/2/2017 ACHARYA CHEMICALS DRIED FERROUS SULFATE USP
### A IV 4/7/2017 UNGERER AND CO ARTIFICIAL BITTERNESS MODIFIER FZ-6965
### A II 5/2/2017 IRVINE SCIENTIFIC SALES CO PRIME-XV® NEURAL BASAL MEDIUM
### A III 4/27/2017 JIANGYIN HAIHUA RUBBER AND HALOGENATED BUTYL RUBBER STOPPER FOR
PLASTIC CO LTD INJECTION
### A II 12/28/2017 NAVINTA LLC PHENOXYBENZAMINE HYDROCHLORIDE USP
### A III 4/27/2017 JIANGYIN HAIHUA RUBBER AND HALOGENATED BUTYL RUBBER STOPPER FOR
PLASTIC CO LTD INJECTION STERILE POWDER
### A III 4/27/2017 JIANGYIN HAIHUA RUBBER AND HALOGENATED BUTYL RUBBER STOPPER FOR
PLASTIC CO LTD INJECTION STERILE FREEZE-DRYING
### A II 5/15/2017 AUROBINDO PHARMA LTD MACITENTAN
### A II 5/31/2017 HETERO LABS LTD VORTIOXETINE HYDROBROMIDE
### A III 6/26/2017 ZHEJIANG HUAHAI PHARMACEUTICAL HDPE BOTTLES (150 CC & 300 CC)
PACKAGING PRODUCTS CO LTD
### A II 5/16/2017 EVOLVA TRANS-RESVERATROL
### A II 9/8/2017 SM BIOMED SDN BHD ERYTHROMYCIN ETHYLSUCCINATE USP
### A IV 5/10/2017 DAVID MICHAEL AND CO INC MICHAELOK® NATURAL LEMON FLAVOR #21947
### A IV 5/10/2017 DAVID MICHAEL AND CO INC MICHAELOK® NATURAL BROWN SUGAR FLAVOR
#21990
### A II 5/20/2017 AUROBINDO PHARMA LTD FLECAINIDE ACETATE USP
### A II 5/31/2017 DR REDDYS LABORATORIES LTD ESLICARBAZEPINE ACETATE
### A II 6/24/2017 APICORE US LLC VORTIOXETINE HYDROBROMIDE PROPYLENE
GLYCOL SOLVATE
### A II 4/20/2017 XIAMEN SINOPEG BIOTECH CO LTD METHOXYPOLY (ETHYLENE GLYCOL)
SUCCINIMIDYL CARBONATE 5K
### A II 6/30/2017 GLENMARK PHARMACEUTICALS LTD OLOPATADINE HYDROCHLORIDE USP
### A II 7/3/2017 BIOCON LTD DAPAGLIFLOZIN
### A II 4/18/2017 ZHEJIANG JIANGBEI PHARMACEUTICAL ATORVASTATIN CALCIUM TRIHYDRATE
CO LTD
### A IV 5/16/2017 FONA INTERNATIONAL INC 884.0143U FONATECH® ORANGE FLAVOR NAT
WONF
### A IV 5/23/2017 FINAR LTD LAURYL LACTATE HP
### A IV 9/6/2017 INDIA PHOSPHATE CALCIUM CITRATE USP
### A IV 9/6/2017 INDIA PHOSPHATE ANHYDROUS CITRIC ACID USP
### A IV 9/6/2017 INDIA PHOSPHATE DIBASIC SODIUM PHOSPHATE USP
### A IV 9/6/2017 INDIA PHOSPHATE MONOBASIC POTASSIUM PHOSPHATE USP
### A IV 9/6/2017 INDIA PHOSPHATE POTASSIUM CHLORIDE USP
### A IV 9/6/2017 INDIA PHOSPHATE POTASSIUM CITRATE USP
### A IV 9/6/2017 INDIA PHOSPHATE SODIUM CHLORIDE USP
### A IV 9/6/2017 INDIA PHOSPHATE SODIUM CITRATE USP
### A IV 5/19/2017 CREST CELLULOSE PRIVATE LTD SODIUM STARCH GLYCOLATE (RAPIGEL)
### A IV 5/19/2017 CREST CELLULOSE PRIVATE LTD DIBASIC CALCIUM PHOSPHATE (CRESTADD)
### A II 8/17/2017 HIGH SCIENCE CO LTD IMIPENEM MONOHYDRATE (STERILE)
### A III 5/17/2017 ENTECO PHARMA SL ALUMINIUM BLISTER
Page 995
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 6/15/2017 LANTECH PHARMACEUTICALS LTD LAMIVUDINE COUPLED ESTER
### A II 6/29/2017 RUSAN PHARMA LTD EFLORNITHINE HYDROCHLORIDE
MONOHYDRATE
### A II 5/29/2017 KANEKA EUROGENTEC SA PRODUCTION OF PLASMID DNA VERSION 3
### A II 5/29/2017 KANEKA EUROGENTEC SA PRODUCTION OF PLASMID DNA VERSION 4
### A II 7/3/2017 MACLEODS PHARMACEUTICALS LTD RIVAROXABAN
### A II 7/20/2018 ADARE PHARMACEUTICALS INC APT-5035 EXTENDED-RELEASE CAPSULES
### A III 4/14/2017 SCHOTT KAISHA PVT LTD GLASS AMPOULES GLASS VIALS GLASS
CARTRIDGES AND GLASS SYRINGES
### A III 3/24/2017 SEASHELL PLASTICS 60 CC HDPE CONTAINER WITH 40MM HDPE
CLOSURE
### A III 6/6/2017 ROY + LECLAIR EMBALLAGE INC INJECTION AND EXTRUSION MOLDED PLASTIC
CONTAINERS FOR USE WITH PHARMACEUTICAL
PRODUCTS
### A II 8/3/2017 AMOLI ORGANICS PVT LTD SOLIFENACIN SUCCINATE
### A II 4/13/2018 ALIVIRA ANIMAL HEALTH LTD (A GROUP TRICLABENDAZOLE
CO OF SEQUENT SCIENTIFIC LTD)
### A II 6/5/2017 DELMAR CHEMICALS INC ESLICARBAZEPINE ACETATE
### A II 6/23/2017 DR REDDYS LABORATORIES LTD IBRUTINIB
### A II 5/23/2017 ZAKLADY FARMACEUTYCZNE BAZEDOXIFENE ACETATE
POLPHARMA SA
### A II 6/2/2017 JUBILANT LIFE SCIENCES LTD 2-HYDROXY-5-METHYLPYRIDINE
### A II 6/22/2017 HOVIONE FARMACIENCIA SA SALMETEROL XINAFOATE INHALATION GRADE
### A II 8/11/2017 GENENTECH INC CED88004A
### A II 8/11/2017 GENENTECH INC CED88004S
### A III 4/3/2017 MAHESH INDUSTRY ALUMINUM CANS AND PRINTED COLLAPSIBLE
TUBES WITH LACQUERED AND LATEX LINING
### A II 5/19/2017 SHANDONG AWA BIOPHARM CO LTD SODIUM HYALURONATE
### A II 5/18/2017 SYNTHETICS CHINA CO LTD SAXAGLIPTIN
### A II 6/6/2017 ZCL CHEMICALS LTD LURASIDONE HYDROCHLORIDE
### A III 5/24/2017 PRAYAG POLYTECH PVT LTD MASTERBATCH
### A II 6/2/2017 CHANGZHOU PHARMACEUTICAL LENALIDOMIDE
FACTORY
### A III 8/22/2017 YABAO PHARMACEUTICAL GROUP CO HDPE BOTTLE AND CHILD-RESISTANT CLOSURE
LTD
### A II 7/24/2017 TOKUYAMA CORP ESCITALOPRAM OXALATE
### A II 4/27/2017 JINZHOU JIUTAI PHARMACEUTICAL CO PANTOPRAZOLE SODIUM
LTD
### A II 9/27/2017 LEK PHARMACEUTICALS DD APREMILAST
### A II 8/28/2017 HANGZHOU HAINA PHARMATECH CO EPTIFIBATIDE
LTD
31811 A II 8/10/2017 EMCURE PHARMACEUTICALS LTD DOFETILIDE USP
### A III 11/13/2017 JIANGSU ZHONGJIN MATAI MEDICINAL A1 / PVC COMPOSITE ALUMINIUM FOIL FOR
PACKAGING CO LTD PACKAGING MEDICINE
### A II 7/31/2017 PROCOS SPA PIRFENIDONE
Page 996
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 7/25/2017 3M DRUG DELIVERY SYSTEMS 3M COTRAN ™ 9694 TRANSFER ADHESIVE ON
LINER
### A II 10/6/2017 DAIICHI SANKYO ALTKIRCH SARL MUCOPOLYSACCHARIDE POLYSULFATE DRUG
SUBSTANCE
### A II 7/24/2017 HETERO DRUGS LTD GABAPENTIN (PROCESS-II)
### A II 8/22/2017 AVANTI POLAR LIPIDS INC TRICAPRYLIN (730412)
### A III 6/4/2017 JIANGSU RUNQI NEW MATERIALS CO ALUMINUM FOIL FOR PHARMACEUTICAL
LTD PACKAGING
### A IV 7/18/2017 SRF LTD DYMEL® 134A/P (1,1,1,2-TETRAFLUOROETHANE)
### A III 7/8/2017 SAI POLYMERS HDPE/PP BOTTLES AND CAPS FOR
PHARMACEUTICAL PACKAGING
### A III 10/24/2017 NICHIBAN CO LTD HS EVOH FILM
### A II 8/2/2017 MACLEODS PHARMACEUTICALS LTD DAPAGLIFLOZIN PREMIX
### A II 7/12/2017 ZHEJIANG HUAHAI PHARMACEUTICAL APREMILAST
CO LTD
### A III 6/28/2017 AMPACET CORP 4700533-N GREEN SMC PP MB
Page 998
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 7/14/2017 ALDRICH CHEMICAL CO CHOLIC ACID-24-13C
### A II 7/14/2017 ALDRICH CHEMICAL CO CHOLIC ACID-2,2,4,4-D4
### A III 7/4/2017 SHIJIAZHUANG ZHONGHUI HIGH DENSITY POLYETHYLENE RESIN
PHARMACEUTICAL PACKAGING CO LTD
### A II 7/14/2017 WANBURY LTD MESALAMINE
### A II 2/9/2018 ZHEJIANG TIANYU PHARMACEUTICAL OLMESARTAN MEDOXOMIL
CO LTD
### A II 7/28/2017 HYBIO PHARMACEUTICAL CO LTD DESMOPRESSIN ACETATE
### A III 7/12/2017 MULTITECH PRODUCTS PVT LTD SILICA GEL POUCHES/DESICCANT POUCHES
FOR PHARMACEUTICAL AND MEDICAL
APPLICATION
### A IV 7/7/2017 COLIBRI SCENTIQUE LLC FRAGRANCE 11316 SOOTHE AWAY AND KILEAH
FRAGRANCE 11302
### A II 7/18/2017 SHILPA MEDICARE LTD GEMCITABINE HYDROCHLORIDE USP
(PROCESS -2)
### A II 7/21/2017 GLAND PHARMA LTD CASPOFUNGIN ACETATE
### A II 12/29/2017 GLENMARK PHARMACEUTICALS LTD ZOLPIDEM TARTRATE USP
### A II 11/28/2017 HONOUR LAB LTD AZILSARTAN KAMEDOXOMIL
### A II 8/24/2017 DASAMI LAB PRIVATE LTD ESLICARBAZEPINE ACETATE
### A II 10/2/2017 SUTRO BIOPHARMA INC PEPTIDE DEFORMYLASE REAGENT
### A II 8/16/2017 SIGMAPHARM LABORATORIES LLC VORTIOXETINE HYDROBROMIDE AMORPHOUS
(24.12%)
### A II 5/10/2017 RAMDEV CHEMICAL PVT LTD BENZOCAINE USP
### A II 7/24/2017 ZHEJIANG CHARIOTEER RIVAROXABAN
PHARMACEUTICAL CO LTD
### A II 5/10/2017 RAMDEV CHEMICAL PVT LTD PIROXICAM USP
### A IV 11/30/2017 GRAIN PROCESSING CORP ALCOHOL PRODUCTS PURE AND DENATURED
### A II 12/11/2017 LIQUIDIA TECHNOLOGIES INC MOLD TEMPLATE FORMULATION 1 FOR PRINT®
PROCESS
### A III 7/13/2017 UDN PACKAGING CORP COLLAPSIBLE PLASTIC TUBES AND CLOSURES
FOR COSMETICS, FOOD, PHARMACEUTICAL
PACKAGING AND PERSONAL CARE PACKAGING.
Page 1000
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 7/27/2017 SHIJIAZHUANG XINFUDA MEDICAL PLASTIC SYRINGE FOR VETERINARY
PACKAGING CO LTD
### A II 8/30/2017 MSN LIFE SCIENCES PRIVATE LTD TASIMELTEON
### A II 8/23/2017 BRIGHTGENE BIOMEDICAL ENTECAVIR MONOHYDRATE
TECHNOLOGY CO LTD
### A II 5/2/2018 BIOCON LTD EVEROLIMUS (2% BHT)
### A II 8/16/2017 RAKS PHARMA PVT LTD DAPAGLIFLOZIN
### A II 8/23/2017 RAKS PHARMA PVT LTD RALOXIFENE HYDROCHLORIDE, USP
### A II 7/29/2017 DIVIS LABORATORIES LTD VIGABATRIN USP
### A II 9/27/2017 MACLEODS PHARMACEUTICALS LTD LURASIDONE HYDROCHLORIDE
### A III 8/6/2017 AMICIS PHARMACON LLP HDPE BOTTLES & CLOSURES FOR PHARMA
PACKAGING
### A II 9/8/2017 LAURUS LABS LTD HYDROXYCHLOROQUINE SULFATE USP
### A II 9/15/2017 LAURUS LABS LTD MACITENTAN
### A II 10/17/2017 LAURUS LABS LTD TENOFOVIR DISOPROXIL FUMARATE
(PROCESS-3)
### A II 8/30/2017 MAITHRI LABORATORIES PRIVATE LTD FLUCYTOSINE USP
### A II 9/13/2017 MSN LABORATORIES PRIVATE LTD LENALIDOMIDE [ROUTE CODE LW]
### A II 8/25/2017 CENTRE FOR PROBE DEVELOPMENT [I-124]IB-PF-06687234 INJECTION
AND COMMERCIALIZATION
### A II 7/5/2017 BIA SEPARATIONS DOO CIM CONVECTIVE INTERACTION MEDIA® OH
HYDROPHOBIC INTERACTION
CHROMATOGRAPHY RESIN
### A II 7/5/2017 BIA SEPARATIONS DOO CIM CONVECTIVE INTERACTION MEDIA® SO3
STRONG CATION EXCHANGE
CHROMATOGRAPHY RESIN
### A II 7/27/2017 WUHAN CALMLAND PHARMACEUTICALS PEMETREXED DISODIUM HEMIPENTAHYDRATE
CO LTD
### A II 8/9/2017 FLEMING LABORATORIES LTD CARISOPRODOL USP
### A III 9/13/2017 SHUBAN PRINTS HSL COATED, LAMINATED & PRINTED
ALUMINIUM FOIL & PLASTIC POUCHES
### A II 11/11/2017 FLEMING LABORATORIES LTD ETODOLAC USP
### A II 9/7/2017 JH NANHANG LIFE SCIENCES CO LTD CROSPOVIDONE
### A IV 7/21/2017 TAKASAGO INTERNATIONAL CORP MIXBERRY FLAVOR B1600948
### A III 8/31/2017 JIAXING LUCKY MOON PACKAGING PACKAGING FILM FOR OXYGEN ABSORBER
MATERIAL CO LTD PACKING - INNO4OA
### A II 7/29/2017 HIKAL LTD CELECOXIB
### A II 9/27/2017 GLENMARK PHARMACEUTICALS LTD ZONISAMIDE USP (D270 PROCESS)
### A II 9/8/2017 VASUDHA PHARMA CHEM LTD NORTRIPTYLINE HYDROCHLORIDE USP
### A II 9/8/2017 VASUDHA PHARMA CHEM LTD ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP
Page 1002
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 9/1/2017 GAURI POLYMERS SILICONE TUBING (PLATINUM & PEROXIDE
CURED), BRAIDED HOSE, GASKETS AND O
RINGS FOR PHARMACEUTICAL USE
### A II 8/30/2017 AUROBINDO PHARMA LTD HYDRALAZINE HYDROCHLORIDE USP
### A II 9/20/2017 BRIGHTGENE BIOMEDICAL EVEROLIMUS (2.0%BHT)
TECHNOLOGY CO LTD
### A II 12/13/2017 HUBEI ENORAY BIOPHARMACEUTICAL ENOXAPARIN SODIUM USP
CO LTD
### A III 8/17/2017 DANAPAK FLEXIBLES AS DANAEXTRA 15-56 COMPOUND PACKAGING
MATERIAL
### A III 8/17/2017 DANAPAK FLEXIBLES AS DANAEXTRA 15-57 COMPOUND PACKAGING
MATERIAL
### A III 8/17/2017 DANAPAK FLEXIBLES AS DANAEXTRA 15-58 COMPOUND PACKAGING
MATERIAL
### A III 8/17/2017 DANAPAK FLEXIBLES AS DANAEXTRA 15-59 COMPOUND PACKAGING
MATERIAL
### A III 8/17/2017 DANAPAK FLEXIBLES AS DANAEXTRA 15-55 COMPOUND PACKAGING
MATERIAL
### A III 8/17/2017 DANAPAK FLEXIBLES AS DANAEXTRA 15-50 COMPOUND PACKAGING
MATERIAL
### A III 8/16/2017 S S ENTERPRISES LAMINATED/COATED PLAIN/PRINTED ALUMINUM
FOIL BLISTER FOIL STRIP FOIL GLASSINE PAPER
TAGGERS & WADS PLAIN/PRINTED ALU-ALU
COLD FORM FOIL CHILD RESISTANT FOIL (CR
FOIL) LAMINATES POUCHES NON TOXIC RIGID
PVC PVC/PVDC AND FLEXIBLE PACKAGING
MATERIALS
### A IV 8/22/2017 FONA INTERNATIONAL INC 815.1171U N-C BUBBLEGUM FLAVOR NAT & ART
### A II 10/6/2017 ALKEM LABORATORIES LTD TOLVAPTAN
### A II 10/27/2017 JIANGSU HENGRUI MEDICINE CO LTD CARMUSTINE USP NON STERILE BULK DRUG
SUBSTANCE
### A II 10/6/2017 LUPIN LTD DROXIDOPA
### A II 12/6/2017 HARMAN FINOCHEM LTD EFINACONAZOLE
### A II 10/22/2018 CATALENT PHARMA SOLUTIONS LLC SOFTGELS [OET - 10258984]
### A II 9/1/2017 BIONPHARMA INC DAPAGLIFLOZIN
### A II 9/21/2017 UNICHEM LABORATORIES LTD CHLORTHALIDONE USP
### A II 8/24/2017 OMYA INC CALCIUM CARBONATE USP
### A II 10/2/2017 CORAL DRUGS PRIVATE LTD FLUTICASONE FUROATE
### A II 10/13/2017 GLAND PHARMA LTD PALIPERIDONE PALMITATE STERILE
### A III 8/29/2017 MITSUBISHI ENGINEERING PLASTICS NOVADURAN® 5010R5XS
CORP
### A IV 8/28/2017 UNGERER AND CO NATURAL STRAWBERRY BANANA FLVP UA 3868
Page 1003
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 9/1/2017 FLEXIFOIL PACKAGING PVT LTD PLAIN, PRINTED, COATED, LAMINATED
ALUMINIUM FOIL, COLD FORMING FOILS, CR
FOILS, TROPICAL BLISTERS, TRIPLE LAMINATED
POUCHES, BAGS, MULTILAYER LAMINATED
FILMS & FLEXIBLE LAMINATES FOR PACKAGING
OF PHARMACEUTICAL PRODUCT
### A III 9/1/2017 SUN SIL POLYMERS PVT LTD SILICONE TRANSPARENT TUBES
(PEROXIDE/PLATINUM CURED), BRAIDED HOSE,
GASKETS, BELLOWS, DIAPHRAGMS, O RINGS,
SHEETS, CORDS, STRIPS FOR
PHARMACEUTICAL USE
### A II 11/23/2017 PICHEM FORSCHUNGS UND NEOBOMB1 (TFA SALT)
ENTWICKLUNGS GMBH
### A II 9/6/2017 CHANGZHOU PHARMACEUTICAL SOFOSBUVIR (AMORPHOUS)
FACTORY
### A II 1/26/2018 MIDAS PHARMA GMBH DOXAPRAM HYDROCHLORIDE
### A IV 10/30/2017 HEPPE MEDICAL CHITOSAN GMBH CHITOSAN HCL
### A II 10/12/2017 HANGZHOU ANOW MICROFILTRATION STERILIZATION-GRADE POLYETHERSULFONE
CO LTD PLEATED CARTRIDGE FILTER (PORE SIZE: 0.22
UM)
### A II 4/30/2018 POSEIDA THERAPEUTICS RIMIDUCID FOR INJECTION
### A III 9/11/2017 ACCRUAL PHARMA PACK LLP SEALS FOR INJECTABLES & OTHER PACKING
PRODUCTS FOR PHARMACEUTICAL COMPANIES
### A III 10/20/2017 JARDEN PLASTICS INC PLASTIC CONTAINERS AND CLOSURES
### A II 11/13/2017 SCINOPHARM TAIWAN LTD APREMILAST
### A II 11/30/2017 MICRO LABS LTD CLOBAZAM
### A II 9/13/2017 PROTO CHEMICAL INDUSTRIES POVIDONE IODINE IP/BP/USP/EP
### A III 2/8/2018 PRESSPART GMBH AND CO KG DOSE COUNTER/DOSE INDICATOR
### A II 10/24/2017 SIEGFRIED EVIONNAZ SA TETRACAINE HYDROCHLORIDE
### A III 8/27/2017 SHIVA INTERNATIONAL DRY SYRUP BOTTLE SET/EYE DROP BOTTLE
SET/TABLET CONTAINER
### A II 9/6/2017 IRVINE SCIENTIFIC SALES CO INC BALANCD® HEK293 FEED (LIQUID)
### A III 9/5/2017 TOYO INK CO LTD M367 PTP HS D2 S VARNISH
### A III 9/11/2017 MITSUBISHI CHEMICAL CORP MODIC H503
### A II 11/10/2017 LAURUS LABS LTD SOFOSBUVIR
### A II 9/28/2017 SOLARA A PHARMA SCIENCES LTD ETHACRYNIC ACID USP
### A II 9/20/2017 CHEMICAL RESOURCES (CHERESO) THIOCOLCHICOSIDE
### A II 11/30/2017 JUBILANT GENERICS LTD APIXABAN
### A II 9/20/2017 CHEMICAL RESOURCES (CHERESO) COLCHICINE BP/USP
### A IV 9/21/2017 XELLIA PHARMACEUTICALS APS N-ACETYL-D-ALANINE
### A II 9/30/2017 ALEMBIC PHARMACEUTICALS LTD IVABRADINE HYDROCHLORIDE
### A II 9/30/2017 ALEMBIC PHARMACEUTICALS LTD SOFOSBUVIR
### A II 11/6/2017 ZHEJIANG AUSUN PHARMACEUTICAL EFINACONAZOLE
CO LTD
Page 1004
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 11/7/2017 ZHEJIANG AUSUN PHARMACEUTICAL TASIMELTEON
CO LTD
### A III 7/31/2017 BADDI FOILS PVT LTD PRINTED, NON PRINTED, COATED & LAMINATED
ALUMINIUM FOILS (BLISTER & STRIP) FOR
PHARMA PACKAGING
### A II 8/28/2017 SUZHOU LIXIN PHARMACEUTICAL CO IDEBENONE (NON-STERILE)
LTD
### I III 9/12/2017 MITSUBISHI GAS CHEMICAL CO INC MXD6-I POLYMER FOR PHARMACEUTICAL
PACKAGING USE
### A III 7/31/2017 BADDI FOILS PVT LTD ROPP CAPS & FLIP OFF SEALS FOR PHARMA
PACKAGING
### A IV 9/7/2017 ABELEI INC 113A113 NATURAL BERRY FLAVOR
### A II 3/26/2018 TARO PHARMACEUTICAL INDUSTRIES TAVABOROLE
LTD
### A II 11/9/2017 SUN PHARMACEUTICAL INDUSTRIES DAPAGLIFLOZIN
LTD
### A II 10/3/2017 ZCL CHEMICALS LTD QUETIAPINE FUMARATE USP
### A II 10/5/2017 APOTEX PHARMACHEM INC TREPROSTINIL DIETHANOLAMINE
### A III 7/31/2017 BADDI FOILS PVT LTD PRINTED, NON PRINTED, COATED & LAMINATED
ALUMINUM FOILS (BLISTER & STRIP) FOR
PHARMA PACKAGING
### A II 9/8/2017 SHANGHAI KYOWA AMINO ACID CO LTD AMINO ACIDS
### A II 4/28/2018 SYMED LABS LTD SUCROFERRIC OXYHYDROXIDE
### A II 11/10/2017 SOLARA A PHARMA SCIENCES LTD FLUCYTOSINE USP
### A II 9/8/2017 YICHANG SANXIA PHARMACEUTICAL CO NEOMYCIN SULFATE AND NEOMYCIN SULFATE
LTD MICRONIZED
### A IV 9/13/2017 FONA INTERNATIONAL INC 815.1170U N-C TUTTI FRUTTI FLAVOR NAT & ART
Page 1021
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 4/5/2018 D.M. PLASTOPACK PVT. LTD. PLASTIC CONTAINERS, CLOSURES & DOSE
MEASURES FOR PHARMACEUTICAL USE
### A IV 4/2/2018 FRUTAROM USA INC FLAVOR FORMULATIONS
### A IV 4/6/2018 SUDEEP PHARMA PVT LTD MAGNESIUM STEARATE USP
### A III 5/16/2018 NIPRO CORP PLBAG-F
### A III 4/2/2018 SUZHOU VALCON TUBE CO LTD COLLAPSIBLE PLASTIC TUBES AND CLOSURES
FOR PHARMACEUTICAL, FOOD, COSMETIC,
INDUSTRIAL AND PERSONAL CARE PACKAGING
### A IV 3/27/2018 BASF SE KOLLIDON® 30 ORIGIN CHINA
(POLYVINYLPYRROLIDONE/POVIDONE/PVP)
### A II 4/13/2018 AUROBINDO PHARMA LTD PIRFENIDONE
### A II 4/17/2018 EMBIO LTD EPHEDRINE SULFATE USP
### A IV 11/22/2018 HUZHOU SUNFLOWER POVIDONE K30
PHARMACEUTICAL CO LTD
### A II 3/31/2018 SUPREEM PHARMACEUTICALS MYSORE VITAMIN D3 STABILIZED 20 IU/MG
PVT LTD
### A II 5/16/2018 AMPHASTAR NANJING INSULIN ASPART USP
PHARMACEUTICALS INC
### A II 4/13/2018 WISDOM PHARMACEUTICAL CO LTD TIROFIBAN HYDROCHLORIDE
### A II 5/14/2018 DISHMAN CARBOGEN AMCIS LTD INDIGOTINDISULFONATE SODIUM
### A II 6/8/2018 BACHEM AG GLUCAGON PHARMA GRADE
### A IV 7/25/2018 PRACHIN CHEMICAL CROSCARMELLOSE SODIUM USP
### A III 4/10/2018 SKYPACK INDIA PVT LTD FLEXIBLE LAMINATES AND COLLAPSIBLE
LAMINATED TUBES WITH CLOSURES FOR
COSMETICS, FOOD, PHARMACEUTICALS,
INDUSTRIAL AND PERSONAL CARE PACKAGING
### A II 5/7/2018 OLON SPA RIFAMYCIN S (SETTIMO SITE)
### A II 4/3/2018 SYMBIOTEC PHARMALAB PRIVATE LTD PROGESTERONE USP
### A IV 3/30/2018 VIKRAM THERMO INDIA LTD DRUGCOAT E 100/E PO/E 12.5 (AMINO
METHACRYLATE COPOLYMER, NF)
32711 A IV 5/18/2018 SUDEEP PHARMA PVT LTD SODIUM BICARBONATE USP
### A II 4/30/2018 MSN LIFE SCIENCES PRIVATE LTD RUFINAMIDE USP
### A III 5/30/2018 SHOHOKU LAMINATE INDUSTRY CO LTD ALUMINIUM FOIL FOR PTP PACKAGING
### A II 4/23/2018 THC PHARM GMBH CANNABIDIOL
### A II 5/16/2018 OLON SPA TOLVAPTAN
### A III 7/25/2018 PHARMACEUTICAL ASSOCIATES INC UNIT DOSE (ORAL LIQUID) PACKAGING SYSTEM
### A II 4/2/2018 ICURE PHARMACEUTICAL INC SURFADONE LP300
### A III 4/9/2018 ECO BIO PLASTICS KOREA CO LTD MAPKA®
### A II 4/30/2018 MSN LIFE SCIENCES PRIVATE LTD ESLICARBAZEPINE ACETATE
### A II 5/7/2018 OLON SPA RIFAMYCIN S (RODANO SITE)
### A IV 9/17/2018 MOLKEREI MEGGLE WASSERBURG INHALAC 500
GMBH AND CO KG
### A II 5/1/2018 APOTEX PHARMACHEM INC ELIGLUSTAT TARTRATE
### A II 6/21/2018 MICRO LABS LTD TENOFOVIR ALAFENAMIDE HEMIFUMARATE
Page 1022
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 4/4/2018 SRP PHARMA FOIL PRINTING PLAIN/PRINTED ALUMINUM FOIL,
PLAIN/PRINTED BLISTER FOIL, PLAIN/PRINTED
ALU-ALU COLD FORM FOIL, CHILD RESISTANT
FOIL (CR FOIL), LAMINATES, POUCHES, VIAL
TRAY, PLASTIC CONTAINERS AND CLOSURES,
NON-TOXIC RIGID PVC / PVDC, PRINTED
GLASSINE POLY/GLASSINE VMCH AND FLEXIBLE
PACKAGING MATERIALS
### A IV 4/16/2018 FONA INTERNATIONAL INC MASTER FILE FONA FLAVORS- FONA
INTERNATIONAL eCTD
### A II 3/28/2018 JIANGSU BROTHER VITAMINS CO LTD THIAMINE HYDROCHLORIDE
### A IV 4/3/2018 SHANDONG HEALSEE CAPSULE LTD HYPROMELLOSE CAPSULE SHELL
### A II 7/2/2018 SHENZHEN TECHDOW ENOXAPARIN SODIUM USP
PHARMACEUTICAL CO LTD
### A II 6/12/2018 EMCURE PHARMACEUTICALS LTD THIOTEPA USP
### A II 4/17/2018 NIPPON YTTRIUM CO LTD GADOLINIUM OXIDE
### A II 5/15/2018 MAPP BIOPHARMACEUTICAL INC CHOK1-AF HOST CELL LINE
### A III 4/20/2018 PROTECH ENGINEERING INDUSTRIES PRINTED, PLAIN, COATED/LAMINATED
PVT LTD ALUMINUM FOILS (BLISTER, STRIP, 4 PLY
LAMINATES & FLEXIBLES) FOR PHARMA
PACKAGING
### A III 4/11/2018 BASELL POLIOLEFINE ITALIA SRL PURELL KT MR 07
### A III 5/22/2018 KITANO CO LTD AIRLESS CONTAINER
### A II 4/16/2018 LABORATOIRES SYNTH-INNOVE BM105
### A IV 4/16/2018 ZHUHAI TOPCHAIN PHARMACEUTICAL MICROCRYSTALLINE CELLULOSE USP
CO LTD
### A II 4/30/2018 RAKS PHARMA PVT LTD BOSENTAN MONOHYDRATE
### A III 4/17/2018 HUAYI ISOTOPES CO STERILE VIAL
### A II 4/18/2018 BIOMEDICAL ELITECELL CORP XENOGENEIC-FREE CELL CULTURE
SUPPLEMENT, EP01
Page 1023
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A III 4/17/2018 ANHUI HUAFENG PHARMACEUTICAL BROMINATED BUTYL RUBBER STOPPER FOR
RUBBER CO LTD INJECTABLE PRODUCTS(AQUEOUS
PARENTERAL PREPARATIONS, POWDERS AND
LYOPHILIZED POWDERS)
### A III 4/20/2018 PIRAMAL GLASS CEYLON PLC GLASS BOTTLES AND JARS
### A II 4/27/2018 STEROID SPA TESTOSTERONE ENANTHATE
### A II 6/21/2018 CHONGQING SOUTHWEST NO 2 BENZOCAINE (NON-STERILE)
PHARMACEUTICAL FACTORY CO LTD
### A III 4/19/2018 AMPACET CORP 166639 BLUE PE MB
### A III 4/17/2018 HANWHA L AND C CORP PVC SHEET (ALUALU)
### A II 5/5/2018 INTERNATIONAL MEDICATION SYSTEMS VASOPRESSIN USP
LTD
### A III 4/27/2018 PRIME PACK INDUCTION SEALING WADS
### A II 5/7/2018 GUANG'AN KINGDAY PHARMA AND DIAZOXIDE USP
CHEM CO LTD
### A II 6/28/2018 ALEMBIC PHARMACEUTICALS LTD PIRFENIDONE
### A III 4/16/2018 AMPACET CORP 10090-K SLIP 90
### A III 4/16/2018 AMPACET CORP 10063-KI ANTIBLOCK 63 I
### A V 6/1/2018 ACS DOBFAR SPA VIA ROSSINI PLANT - LINE 2
### A II 5/17/2018 LEK PHARMACEUTICALS DD CLAVULANATE POTASSIUM DILUTED WITH
SILICON DIOXIDE 1:1
### A II 5/10/2018 STEROID SPA DIFLUPREDNATE
### A III 6/15/2018 TAKEUCHI PRESS INDUSTRIES CO LTD TAKEUCHI MEMBRANE TUBE
### A II 4/21/2018 JIANGXI SYNERGY PHARMACEUTICAL FEBUXOSTAT
CO LTD
### A II 4/21/2018 JIANGXI SYNERGY PHARMACEUTICAL APIXABAN
CO LTD
### A II 4/21/2018 JIANGXI SYNERGY PHARMACEUTICAL DABIGATRAN ETEXILATE MESYLATE
CO LTD
### A II 4/25/2018 CHONGQING HUAPONT FLUTICASONE PROPIONATE INTERMEDIATE
PHARMACEUTICAL CO LTD
### A III 4/17/2018 ZHONGSHAN HUIFENG MEDICAL HDPE BOTTLES FOR ORAL SOLID PREPARATION
PACKAGING TECHNOLOGY CO LTD (CONTAIN BOTTLE BODY CAP AND CLOSURE
LINER)
### A II 5/30/2018 HOVIONE PHARMASCIENCE LTD SALMETEROL XINAFOATE MICRONIZED
### A II 1/19/2018 HENAN TOPFOND SCI-TECH CO LTD SIMVASTATIN AMMONIUM SALT (DRUG
SUBSTANCE INTERMEDIATE)
### A IV 4/27/2018 NICHIRIN CHEMICAL INDUSTRIES LTD GRANFILLER-D
### A IV 4/27/2018 CREST CELLULOSE PRIVATE LTD METHACRYLIC ACID COPOLYMER DISPERSION
(L30D 55)
### A III 4/27/2018 TROPACK PACKMITTEL GMBH DESICCANT BAG TM MINIBAG 2G MOLECULAR
SIEVE 4A/TYVEK
### A IV 4/27/2018 CREST CELLULOSE PRIVATE LTD CROSCARMELLOSE SODIUM (CRESTCROSS)
### A IV 4/16/2018 RANK ORGANICS CHEMICAL PVT LTD SODIUM STEARYL FUMARATE USP/NF
### A II 4/16/2018 RANK ORGANICS CHEMICAL PVT LTD NAPHAZOLINE HCL USP
Page 1024
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 5/17/2018 AMOLI ORGANICS PVT LTD ROSUVASTATIN CALCIUM
### A III 5/8/2018 KEY PACKAGING CO INC THERMOFORMED CUPS
### A II 5/18/2018 CHEMO IBERICA SA PIRFENIDONE
### A IV 5/17/2018 NIPPON FINE CHEMICAL CO LTD A LIPOSOMAL EXCIPIENT, DIPALMITOYL
PHOSPHATIDYLGLYCEROL (DPPG)
### A II 4/27/2018 PARTNERS PHARMACEUTICALS INC PNEUMOCANDIN B0
### A III 4/27/2018 PELICAN POLY AND PALLETS PVT LTD LDPE/LLDPE LINER BAGS
### A III 4/24/2018 PRANIL POLYMERS LTD HDPE BOTTLES AND PP CLOSURES
### A III 4/27/2018 AMPACET CORP 10966 ZINC STEARATE HDPE MB
### A III 5/1/2018 TECHMER PM PM 112025 LOW ODOR OLEAMIDE SLIP
### A IV 5/14/2018 ARJUN BEESWAX INDUSTRIES BEESWAX SLABS/PASTILLES IP, BP, USP
### A III 4/28/2018 TIANJIN BOKELIN MEDICAL PACKAGING PLASTIC HDPE BOTTLES FOR
TECHNOLOGY CO LTD PHARMACEUTICAL USE
### A III 5/1/2018 TECHMER PM PM19236 ANTIBLOCK
### A IV 7/10/2018 CELANESE CANADA ULC ETHYLENE VINYL ACETATE COPOLYMER,
VITALDOSE® K2917.X01
### A IV 7/10/2018 CELANESE CANADA ULC ETHYLENE VINYL ACETATE COPOLYMER,
VITALDOSE® K2918.X01
32811 A II 5/15/2018 SINOPHARM WEIQIDA AMOXICILLIN TRIHYDRATE, USP
PHARMACEUTICAL CO LTD
### A II 6/17/2018 TEVA PHARMACEUTICAL INDUSTRIES MICAFUNGIN SODIUM
LTD
### A II 8/8/2018 GUANG'AN KINGDAY PHARMA AND FOSPHENYTOIN SODIUM USP
CHEM CO LTD
### A II 6/1/2018 CRYSTAL PHARMA SAU SUBSIDIARY OF TESTOSTERONE MICRONIZED
AMRI
### A II 6/29/2018 MOEHS IBERICA SL PRILOCAINE
### A III 5/4/2018 MAEDA INDUSTRY CO LTD LLA MS/LLA 11.25 MG
### A III 5/14/2018 POLY SEALS EPE WADS/SHEETS/PLAIN RINGS/GASKETS FOR
PHARMA USE
### A III 5/16/2018 NIPRA INDUSTRIES PVT LTD ROPP CLOSURES
### A II 5/15/2018 FUZHOU CONTAY BIOTECHNOLOGY CO MUPIROCIN
LTD
### A II 8/21/2018 BIOCARE PHARMACEUTICAL LTD SODIUM SALICYLATE NON-STERILE BULK DRUG
SUBSTANCE
### A II 5/24/2018 UQUIFA MEXICO SA DE CV RIVAROXABAN
### A III 5/3/2018 AMPACET CORP 151810 STOCK RED PP MB
### A II 6/26/2018 BEIJING THTD PHARMACEUTICAL VONOPRAZAN FUMARATE
TECHNOLOGY CO LTD
### A II 5/24/2018 FUZHOU CONTAY BIOTECHNOLOGY CO MUPIROCIN CALCIUM
LTD
### A II 9/11/2018 ADARE PHARMACEUTICALS INC APT-5074 DELAYED-RELEASE TABLETS
### A IV 5/22/2018 FINAR LTD METHANE SULPHONIC ACID HP
### A II 6/19/2018 ENALTEC LABS PRIVATE LTD VARENICLINE TARTRATE
Page 1025
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A IV 7/6/2018 AQUADRY EXCIPIENTS PVT LTD AQUADRY SUGAR COATING SYSTEM USING
COLOUR
### A II 7/16/2018 KAIYUAN BIOPHARMA CO LTD (2S,5R)-5-METHYL-2-(PROPAN-2-
YL)CYCLOHEXYL(2R,5S)-5-(4-AMINO-2-OXO-1,2-
DIHYDROPYRIMIDIN-1-YL)-1,3-OXATHIOLANE-2-
CARBOXYLATE
### A II 6/4/2018 PCAS ZUCLOMIPHENE CITRATE
### A II 5/23/2018 DISHMAN CARBOGEN AMCIS LTD DIACETONE FRUCTOSE
### A II 7/9/2018 CHONGQING CARELIFE SORAFENIB TOSYLATE
PHARMACEUTICAL CO LTD
### A II 7/12/2018 JUNGBUNZLAUER LADENBURG GMBH TRISODIUM CITRATE DIHYDRATE
### A II 6/26/2018 BIOPHORE INDIA PHARMACEUTICALS CHLORZOXAZONE
PVT LTD
### A III 6/12/2018 SHENZHEN CHUNWANG OXYGEN ABSORBER
ENVIRONMENTAL PROTECTION
TECHNOLOGY CO LTD
### A III 5/17/2018 HMC POLYMERS CO LTD PURELL RP171G
### A II 6/26/2018 EPAX NORWAY AS EPAX 5010 EE US Ph
### A III 5/16/2018 COLORTECH INC 11521-16 WHITE POLYETHYLENE CONCENTRATE
Page 1033
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 9/21/2018 YICHANG HUMANWELL REMIFENTANIL HYDROCHLORIDE
PHARMACEUTICAL CO LTD
### A II 9/28/2018 HUBEI HUMANWELL CHENGTIAN NINTEDANIB ESYLATE
PHARMACEUTICAL CO LTD
### A II 9/28/2018 CHINOIN PHARMACEUTICAL AND ILOPROST
CHEMICAL WORKS PRIVATE CO LTD
### A II 9/22/2018 SIONC PHARMACEUTICALS PVT LTD VIGABATRIN
### A III 9/10/2018 MEDICAP HEALTHCARE LTD EURO HEAD CAPS FOR PLASTIC INFUSION
BOTTLES
### A II 9/11/2018 SUNPURE EXTRACTS PVT LTD CENTELLA ASIATICA DRY EXTRACT 45%
### A II 9/6/2018 OLON SPA CLOFAZIMINE
### A IV 12/11/2018 ANHUI SUNHERE PHARMACEUTICAL HYPROMELLOSE
EXCIPIENTS CO LTD
### A IV 12/11/2018 ANHUI SUNHERE PHARMACEUTICAL CARBOXYMETHYLCELLULOSE SODIUM
EXCIPIENTS CO LTD
### A IV 12/11/2018 ANHUI SUNHERE PHARMACEUTICAL MICROCRYSTALLINE CELLULOSE
EXCIPIENTS CO LTD
### A II 9/28/2018 UNICHEM LABORATORIES LTD MONTELUKAST SODIUM USP
### A II 9/28/2018 UNICHEM LABORATORIES LTD ATOMOXETINE HYDROCHLORIDE USP
### A II 12/7/2018 NOVITIUM PHARMA LLC CARGLUMIC ACID
### A II 9/29/2018 MACLEODS PHARMACEUTICALS LTD LOSARTAN POTASSIUM
### A II 10/17/2018 MANNKIND CORP TREPROSTINIL INHALATION POWDER
### A II 10/10/2018 ASTRAZENECA PHARMACEUTICAL LP BUDESONIDE
### A II 11/5/2018 CIPLA LTD FLUTICASONE PROPIONATE USP (PROCESS III)
### A II 11/2/2018 APOTEX PHARMACHEM INC ZIPRASIDONE HYDROCHLORIDE
MONOHYDRATE USP
### A II 9/24/2018 AARTI INDUSTRIES LTD MOMETASONE FUROATE USP (ALTERNATE
PROCESS)
### A II 9/16/2018 WISDOM PHARMACEUTICAL CO LTD APREPITANT
### A II 10/8/2018 MODIS THERAPEUTICS INC MT1621 (DRUG SUBSTANCE)
### A II 10/8/2018 MODIS THERAPEUTICS INC MT1621 DRUG PRODUCT
### A II 9/13/2018 FUXIN LONG RUI PHARMACEUTICAL CO VILDAGLIPTIN
LTD
### A III 11/19/2018 TAKAKYU INDUSTRIES CO LTD TAKAPLAIN
### A II 9/27/2018 ZAKLADY FARMACEUTYCZNE EMPAGLIFLOZIN
POLPHARMA SA
### A V 9/26/2018 STERIS CONTRACT STERILIZATION FACILITY IN GRAND
PRAIRIE, TX
### A V 9/26/2018 STERIS CONTRACT STERILIZATION FACILITY IN
MINNEAPOLIS, MN
### A V 9/26/2018 STERIS CONTRACT STERILIZATION FACILITY IN SOUTH
PLAINFIELD, NJ
Page 1034
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A V 9/26/2018 STERIS CONTRACT STERILIZATION FACILITY IN SAN
DIEGO, CA
### A V 9/26/2018 STERIS CONTRACT STERILIZATION FACILITY IN
TEMECULA, CA
### A V 9/26/2018 STERIS CONTRACT STERILIZATION FACILITY AT 1435
ISOMEDIX PLACE, EL PASO, TX
### A V 9/26/2018 STERIS CONTRACT STERILIZATION FACILITY IN EL
PASO, TX
### A III 8/31/2018 KOREA ENGINEERING PLASTIC CO LTD KEPITAL ACETAL RESIN (MX SERIES)
### A II 10/4/2018 NANOPHARMACEUTICS LLC TRIAPINE DRUG SUBSTANCE
### A III 10/8/2018 AARTS PLASTICS BV CONTAINER CLOSURE SYSTEM
### A V 9/26/2018 STERIS CONTRACT STERILIZATION FACILITY IN
ALAJUELA, COSTA RICA
### A II 10/16/2018 BRIGHTGENE BIOMEDICAL ((3S,5R)-5-((1H-1,2,4-TRIAZOL-1-YL)METHYL)-5-
TECHNOLOGY CO LTD (2,4-DIFLUOROPHENYL)TETRAHYDROFURAN-3-
YL)METHYL 4-
METHYLBENZENESULFONATE(POSACONAZOLE
INTERMEDIATE POA)
### A II 10/9/2018 BRIGHTGENE BIOMEDICAL 2-[(1S,2S)-1-ETHY1-2-BEZYLOXYPROPYL]-2,4-
TECHNOLOGY CO LTD DIHYDRO-4-[4-[4-(4-HYDROXYPHENYL) -1-
PIPERAZINYL]PHENYL]- 3H-1,2,4-TRIAZOL-3-ONE
(POSACONAZOLE INTERMEDIATE POB)
### A II 9/29/2018 MSN LABORATORIES PRIVATE LTD LENVATINIB
### A II 9/29/2018 MSN LABORATORIES PRIVATE LTD NILOTINIB
### A II 9/29/2018 MACLEODS PHARMACEUTICALS LTD METFORMIN HYDROCHLORIDE
### A II 9/28/2018 EMCURE PHARMACEUTICALS LTD ISOSULFAN BLUE
### A II 9/28/2018 AUROBINDO PHARMA LTD PENICILLAMINE USP
### A II 10/4/2018 YUNG ZIP CHEMICAL IND CO LTD METOPROLOL SUCCINATE (PROCESS II)
### A II 12/3/2018 ZAKLADY FARMACEUTYCZNE CHLORPROMAZINE HYDROCHLORIDE
POLPHARMA SA
### A II 10/30/2018 ZAKLADY FARMACEUTYCZNE ARIPIPRAZOLE MONOHYDRATE
POLPHARMA SA
### A II 10/11/2018 TEREOS STARCH AND SWEETENERS DEXTROSE MONOHYDRATE(MERIDEX, MERIDEX
LBERIA S.A.U. PF)
### A II 9/28/2018 MOEHS IBERICA SL SITAGLIPTIN PHOSPHATE MONOHYDRATE
### A II 9/28/2018 INDENA SPA DOCETAXEL TRIHYDRATE
33211 A II 9/28/2018 USV PRIVATE LTD DOLASETRON MESYLATE USP
### A II 12/7/2018 USV PRIVATE LTD ICATIBANT ACETATE
### A II 10/15/2018 URQUIMA SA IVABRADINE HYDROCHLORIDE (FORM IV)
### A II 9/29/2018 BIOPHORE INDIA PHARMACEUTICALS PROCAINAMIDE HYDROCHLORIDE USP
PVT LTD
### A II 9/28/2018 BIOPHORE INDIA PHARMACEUTICALS TIPIRACIL HYDROCHLORIDE
PVT LTD
### A II 10/1/2018 BIOPHORE INDIA PHARMACEUTICALS CRISABOROLE
PVT LTD
Page 1035
DMF# STATUS TYP SUBMIT DATE HOLDER NQYYYYEXCEL
SUBJECT
0 I II 2/8/1981 HEXCEL CHEMICAL PRODUCTS CPC
### A II 10/30/2018 LUPIN LTD PROPRANOLOL HYDROCHLORIDE USP
### A II 12/31/2018 NOVITIUM PHARMA LLC LEVORPHANOL TARTRATE USP
### A II 9/28/2018 HETERO DRUGS LTD VIGABATRIN
### A II 9/29/2018 RL FINE CHEM PVT LTD NORTRIPTYLINE HYDROCHLORIDE
### A II 10/17/2018 MAITHRI DRUGS PRIVATE LTD DOCOSANOL
### A II 9/29/2018 MAITHRI LABORATORIES PRIVATE LTD FESOTERODINE FUMARATE
### A II 10/19/2018 SCINOPHARM TAIWAN LTD BREXPIPRAZOLE
### A II 10/30/2018 MSN LIFE SCIENCES PRIVATE LTD SACUBITRIL SODIUM
### A II 11/16/2018 CHATTEM CHEMICALS INC AMPHETAMINE SULFATE USP
### A II 9/29/2018 ZHEJIANG HISUN PHARMACEUTICAL CO ROMIDEPSIN
LTD
### A II 12/13/2018 HUNAN XIANGYIKANG SULFADIAZINE USP
PHARMACEUTICAL CO LTD
### A II 10/21/2018 DISHMAN BIOTECH LTD CHLORHEXIDINE GLUCONATE SOLUTION
### A II 10/16/2018 FIS FABBRICA ITALIANA SINTETICI SPA TESTOSTERONE PROPIONATE
### A II 11/10/2018 VIWIT PHARMACEUTICAL CO LTD (2R,3R)-2-(2,4-DIFLUOROPHENYL)-1-(1H-1,2,4-
TRIAZOL-1-YL)BUTANE-2,3-DIOL
### A II 10/16/2018 TURTLE PHARMA PRIVATE LTD LEVOFLOXACIN HEMIHYDRATE USP
### A II 10/16/2018 TURTLE PHARMA PRIVATE LTD CIPROFLOXACIN HYDROCHLORIDE USP
### A II 10/30/2018 MAITHRI LABORATORIES PRIVATE LTD
IVABRADINE HYDROCHLORIDE
Page 1041