DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 1

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** 3 **

3M

* 3M CO

PERIDEX, CHLORHEXIDINE GLUCONATE

* 3M HEALTH CARE INC

AVAGARD, ALCOHOL (OTC)

DURAPREP, IODINE POVACRYLEX (OTC)

* 3M PHARMACEUTICALS INC

PROVENTIL-HFA, ALBUTEROL SULFATE

AAIPHARMA LLC

* AAIPHARMA LLC

AZASAN, AZATHIOPRINE

AB GENERICS

* AB GENERICS LP

MORPHINE SULFATE, MORPHINE SULFATE

ABBOTT

* ABBOTT LABORATORIES

ADVICOR, LOVASTATIN

AKINETON, BIPERIDEN HYDROCHLORIDE

AZMACORT, TRIAMCINOLONE ACETONIDE

BIAXIN XL, CLARITHROMYCIN

BIAXIN, CLARITHROMYCIN

CYCLOSPORINE, CYCLOSPORINE

DEPAKOTE ER, DIVALPROEX SODIUM

DEPAKOTE, DIVALPROEX SODIUM

GENGRAF, CYCLOSPORINE

KALETRA, LOPINAVIR

NIASPAN, NIACIN

NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE

NIMBEX, CISATRACURIUM BESYLATE

NORVIR, RITONAVIR

OMNICEF, CEFDINIR

SIMCOR, NIACIN

SYNTHROID, LEVOTHYROXINE SODIUM

TEVETEN HCT, EPROSARTAN MESYLATE

TEVETEN, EPROSARTAN MESYLATE

ULTANE, SEVOFLURANE

ZEMPLAR, PARICALCITOL

* ABBOTT LABORATORIES HOSP PRODUCTS DIV

CALCIJEX, CALCITRIOL

* ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV

BIAXIN, CLARITHROMYCIN

DEPACON, VALPROATE SODIUM

DEPAKENE, VALPROIC ACID

DEPAKOTE, DIVALPROEX SODIUM

E.E.S. 200, ERYTHROMYCIN ETHYLSUCCINATE

E.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATE

E.E.S., ERYTHROMYCIN ETHYLSUCCINATE

E-MYCIN, ERYTHROMYCIN

ENDURON, METHYCLOTHIAZIDE

ERYDERM, ERYTHROMYCIN

ERYPED, ERYTHROMYCIN ETHYLSUCCINATE

ERY-TAB, ERYTHROMYCIN

ERYTHROCIN STEARATE, ERYTHROMYCIN STEARATE

ERYTHROMYCIN, ERYTHROMYCIN

HYTRIN, TERAZOSIN HYDROCHLORIDE

K-TAB, POTASSIUM CHLORIDE

MAVIK, TRANDOLAPRIL

MERIDIA, SIBUTRAMINE HYDROCHLORIDE

NORVIR, RITONAVIR

ORETIC, HYDROCHLOROTHIAZIDE

PCE, ERYTHROMYCIN

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

TARKA, TRANDOLAPRIL

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 2

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV

TRICOR, FENOFIBRATE

TRIDIONE, TRIMETHADIONE

VICODIN ES, ACETAMINOPHEN

VICODIN HP, ACETAMINOPHEN

VICODIN, ACETAMINOPHEN

VICOPROFEN, HYDROCODONE BITARTRATE

ZEMPLAR, PARICALCITOL

ABBOTT ENDO

* ABBOTT ENDOCRINE INC SUB ABBOTT LABORATORIES

LUPRON DEPOT, LEUPROLIDE ACETATE

LUPRON DEPOT-3, LEUPROLIDE ACETATE

LUPRON DEPOT-4, LEUPROLIDE ACETATE

LUPRON DEPOT-PED, LEUPROLIDE ACETATE

LUPRON, LEUPROLIDE ACETATE

ABBOTT LABS

* ABBOTT LABORATORIES

TRILIPEX, CHOLINE FENOFIBRATE

ABRAXIS BIOSCIENCE

* ABRAXIS BIOSCIENCE INC

ASTRAMORPH PF, MORPHINE SULFATE

DIPRIVAN, PROPOFOL

POLOCAINE, MEPIVACAINE HYDROCHLORIDE

POLOCAINE-MPF, MEPIVACAINE HYDROCHLORIDE

SENSORCAINE, BUPIVACAINE HYDROCHLORIDE

* ABRAXIS BIOSCIENCE LLC

ABRAXANE, PACLITAXEL

ABRAXIS PHARM

* ABRAXIS PHARMACEUTICAL PRODUCTS

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM

ADENOSINE, ADENOSINE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AZITHROMYCIN, AZITHROMYCIN

BACITRACIN, BACITRACIN

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

CAFFEINE CITRATE, CAFFEINE CITRATE

CALCITRIOL, CALCITRIOL

CARBOPLATIN, CARBOPLATIN

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFOTAXIME, CEFOTAXIME SODIUM

CEFOTETAN, CEFOTETAN DISODIUM

CEFOXITIN, CEFOXITIN SODIUM

CEFTRIAXONE, CEFTRIAXONE SODIUM

CEFUROXIME SODIUM, CEFUROXIME SODIUM

CHLORAMPHENICOL SODIUM SUCCINATE, CHLORAMPHENICOL SODIUM SUCCINATE

CISPLATIN, CISPLATIN

CLADRIBINE, CLADRIBINE

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CYTARABINE, CYTARABINE

DACARBAZINE, DACARBAZINE

DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DIMENHYDRINATE, DIMENHYDRINATE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

DOXY 100, DOXYCYCLINE HYCLATE

DOXY 200, DOXYCYCLINE HYCLATE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

ETOPOSIDE, ETOPOSIDE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 3

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ABRAXIS PHARMACEUTICAL PRODUCTS

FAMOTIDINE, FAMOTIDINE

FLOXURIDINE, FLOXURIDINE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

FLUMAZENIL, FLUMAZENIL

FLUOROURACIL, FLUOROURACIL

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FOLIC ACID, FOLIC ACID

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

FUROSEMIDE, FUROSEMIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

IFOSFAMIDE, IFOSFAMIDE

IOPAMIDOL-250, IOPAMIDOL

IOPAMIDOL-300, IOPAMIDOL

IOPAMIDOL-370, IOPAMIDOL

KANAMYCIN, KANAMYCIN SULFATE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MANNITOL 25%, MANNITOL

MESNA, MESNA

METARAMINOL BITARTRATE, METARAMINOL BITARTRATE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE, MILRINONE LACTATE

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

POTASSIUM CHLORIDE IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PROGESTERONE, PROGESTERONE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

PYRIDOXINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, WATER FOR INJECTION, STERILE

TERBUTALINE SULFATE, TERBUTALINE SULFATE

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

THIOTEPA, THIOTEPA

TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

VALPROATE SODIUM, VALPROATE SODIUM

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VIBISONE, CYANOCOBALAMIN

VINBLASTINE SULFATE, VINBLASTINE SULFATE

VINCRISTINE SULFATE, VINCRISTINE SULFATE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

ABRAXIS PHARM PRODS

* ABRAXIS PHARMACEUTICAL PRODUCTS DIV ABRAXIS BIOSCIENCE INC

CAFFEINE CITRATE, CAFFEINE CITRATE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

POLYMXIN B SULFATE, POLYMYXIN B SULFATE

ACCORD HLTH

* ACCORD HEALTH CARE INC

METHYLDOPA, METHYLDOPA

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 4

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

ACCORD HLTHCARE

* ACCORD HEALTHCARE INC

GLIMEPIRIDE, GLIMEPIRIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

MITOMYCIN, MITOMYCIN

SIMVASTATIN, SIMVASTATIN

ACCORD HLTHCARE INC

* ACCORD HEALTHCARE INC USA

ETOPOSIDE, ETOPOSIDE

PACLITAXEL, PACLITAXEL

ACORDA

* ACORDA THERAPEUTICS INC

ZANAFLEX, TIZANIDINE HYDROCHLORIDE

ACS DOBFAR

* ACS DOBFAR SPA

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE

CEFTAZIDIME, CEFTAZIDIME

CEFTRIAXONE, CEFTRIAXONE SODIUM

KEFZOL, CEFAZOLIN SODIUM

ACS DOBFAR INFO SA

* ACS DOBFAR INFO SA

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

ACTAVIS

* ACTAVIS SOUTHATLANTIC LLC

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

FENTANYL-100, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-75, FENTANYL

NIFEDIPINE, NIFEDIPINE

ACTAVIS ELIZABETH

* ACTAVIS ELIZABETH LLC

ACYCLOVIR, ACYCLOVIR

ALPRAZOLAM, ALPRAZOLAM

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN

CARBAMAZEPINE, CARBAMAZEPINE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CARVEDILOL, CARVEDILOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLONAZEPAM, CLONAZEPAM

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DIAZEPAM, DIAZEPAM

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

ETODOLAC, ETODOLAC

FAMOTIDINE, FAMOTIDINE

FENOPROFEN CALCIUM, FENOPROFEN CALCIUM

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

GABAPENTIN, GABAPENTIN

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

INDAPAMIDE, INDAPAMIDE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

KADIAN, MORPHINE SULFATE

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LORAZEPAM, LORAZEPAM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 5

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ACTAVIS ELIZABETH LLC

LOVASTATIN, LOVASTATIN

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

NAPROXEN, NAPROXEN

NIFEDIPINE, NIFEDIPINE

OXAPROZIN, OXAPROZIN

OXAZEPAM, OXAZEPAM

OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN

PENTOXIFYLLINE, PENTOXIFYLLINE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, ACETAMINOPHEN

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

PROPYLTHIOURACIL, PROPYLTHIOURACIL

RAMIPRIL, RAMIPRIL

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SPIRONOLACTONE, SPIRONOLACTONE

TEMAZEPAM, TEMAZEPAM

TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOLMETIN SODIUM, TOLMETIN SODIUM

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

ACTAVIS MID ATLANTIC

* ACTAVIS MID ATLANTIC LLC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

ACETASOL HC, ACETIC ACID, GLACIAL

ACETASOL, ACETIC ACID, GLACIAL

ACYCLOVIR, ACYCLOVIR

ALBUTEROL SULFATE, ALBUTEROL SULFATE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

CAPITAL AND CODEINE, ACETAMINOPHEN

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

CICLOPIROX, CICLOPIROX

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CLOTRIMAZOLE, CLOTRIMAZOLE (OTC)

CONSTULOSE, LACTULOSE

CROMOLYN SODIUM, CROMOLYN SODIUM

CROMOLYN SODIUM, CROMOLYN SODIUM (OTC)

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

ENULOSE, LACTULOSE

FLUOCINONIDE, FLUOCINONIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GRISEOFULVIN, GRISEOFULVIN, MICROCRYSTALLINE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

HALOPERIDOL LACTATE, HALOPERIDOL LACTATE

HYDROCODONE COMPOUND, HOMATROPINE METHYLBROMIDE

HYDROCORTISONE, HYDROCORTISONE

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

INFANTS' FEVERALL, ACETAMINOPHEN (OTC)

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LEVETIRACETAM, LEVETIRACETAM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 6

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ACTAVIS MID ATLANTIC LLC

LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE

MICONAZOLE 7, MICONAZOLE NITRATE (OTC)

MICONAZOLE NITRATE, MICONAZOLE NITRATE

MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

MYKACET, NYSTATIN

M-ZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

M-ZOLE 7 DUAL PACK, MICONAZOLE NITRATE (OTC)

NYSTATIN, NYSTATIN

PERMETHRIN, PERMETHRIN

PERMETHRIN, PERMETHRIN (OTC)

PHENYTOIN, PHENYTOIN

PROMETH VC PLAIN, PHENYLEPHRINE HYDROCHLORIDE

PROMETH VC W/ CODEINE, CODEINE PHOSPHATE

PROMETH W/ CODEINE, CODEINE PHOSPHATE

PROMETH W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE

SELENIUM SULFIDE, SELENIUM SULFIDE

SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE

THEOPHYLLINE, THEOPHYLLINE

THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VALNAC, BETAMETHASONE VALERATE

ACTAVIS TOTOWA

* ACTAVIS TOTOWA LLC

ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE, ACETAMINOPHEN

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

BACLOFEN, BACLOFEN

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CARISOPRODOL AND ASPIRIN, ASPIRIN

CARISOPRODOL, CARISOPRODOL

CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN

CHLORZOXAZONE, CHLORZOXAZONE

CILOSTAZOL, CILOSTAZOL

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DANTROLENE SODIUM, DANTROLENE SODIUM

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

DIGOXIN, DIGOXIN

DIPYRIDAMOLE, DIPYRIDAMOLE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

FINASTERIDE, FINASTERIDE

GLYBURIDE, GLYBURIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HOMATROPRINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

ISRADIPINE, ISRADIPINE

LOXAPINE SUCCINATE, LOXAPINE SUCCINATE

MELOXICAM, MELOXICAM

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

METHIMAZOLE, METHIMAZOLE

MIRTAZAPINE, MIRTAZAPINE

NALOXONE HYDROCHLORIDE AND PENTAZOCAINE, NALOXONE HYDROCHLORIDE

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 7

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ACTAVIS TOTOWA LLC

PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

QUINARETIC, HYDROCHLOROTHIAZIDE

RIMACTANE, RIFAMPIN

RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE

URSODIOL, URSODIOL

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ACTELION

* ACTELION LTD

TRACLEER, BOSENTAN

ACTELION PHARM

* ACTELION PHARMACEUTICAL LTD

VENTAVIS, ILOPROST

ACTELION PHARMS

* ACTELION PHARMACEUTICALS US INC

ZAVESCA, MIGLUSTAT

ADAMS RESP THERAP

* ADAMS RESPIRATORY THERAPEUTICS

DELSYM, DEXTROMETHORPHAN POLISTIREX (OTC)

ADOLOR

* ADOLOR CORP

ENTEREG, ALVIMOPAN

ADVENT PHARMS

* ADVENT PHARMACEUTICALS INC

CARISOPRODOL, CARISOPRODOL

IBUPROFEN, IBUPROFEN (OTC)

AEGIS PHARMS

* AEGIS PHARMACEUTICALS INC

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

AESGEN

* AESGEN INC

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

AGOURON

* AGOURON PHARMACEUTICALS INC

RESCRIPTOR, DELAVIRDINE MESYLATE

VIRACEPT, NELFINAVIR MESYLATE

AKORN

* AKORN INC

ADENOSINE, ADENOSINE

AKBETA, LEVOBUNOLOL HYDROCHLORIDE

AK-FLUOR 10%, FLUORESCEIN SODIUM

AK-FLUOR 25%, FLUORESCEIN SODIUM

AKPENTOLATE, CYCLOPENTOLATE HYDROCHLORIDE

AKPRO, DIPIVEFRIN HYDROCHLORIDE

AKTEN, LIDOCAINE HYDROCHLORIDE

AKTOB, TOBRAMYCIN

ALFENTA, ALFENTANIL HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC

BAL, DIMERCAPROL

BALANCED SALT, CALCIUM CHLORIDE

BETAXOLOL, BETAXOLOL HYDROCHLORIDE

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

CALCITRIOL, CALCITRIOL

CROMOLYN SODIUM, CROMOLYN SODIUM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 8

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AKORN INC

DICLOFENAC SODIUM, DICLOFENAC SODIUM

ENDOSOL EXTRA, CALCIUM CHLORIDE

ERYTHROMYCIN, ERYTHROMYCIN

GENTAK, GENTAMICIN SULFATE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

IC-GREEN, INDOCYANINE GREEN

INAPSINE, DROPERIDOL

KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

NEOMYCIN AND POLYMYXIN B SULFATE AND BACITRACIN ZINC, BACITRACIN ZINC

OFLOXACIN, OFLOXACIN

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

PAREMYD, HYDROXYAMPHETAMINE HYDROBROMIDE

SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TERBUTALINE SULFATE, TERBUTALINE SULFATE

TIMOLOL MALEATE, TIMOLOL MALEATE

TROPICACYL, TROPICAMIDE

AKORN INC

* AKORN INC

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

AKORN MFG

* AKORN MANUFACTURING INC

SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE

AKORN STRIDES

* AKORN STRIDES LLC

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE

FLUMAZENIL, FLUMAZENIL

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

RIFAMPIN, RIFAMPIN

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

AKRIMAX PHARMS

* AKRIMAX PHARMACEUTICALS LLC

INDERAL, PROPRANOLOL HYDROCHLORIDE

INDERIDE-40/25, HYDROCHLOROTHIAZIDE

AKYMA PHARMS

* AKYMA PHARMACEUTICALS LLC

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

AL AND S

* AL AND S LLC

LINDANE, LINDANE

ALARA PHARM

* ALARA PHARMACEUTICAL CORPORATION

LEVO-T, LEVOTHYROXINE SODIUM

ALAVEN PHARM

* ALAVEN PHARMACEUTICAL LLC

ANADROL-50, OXYMETHOLONE

REGLAN ODT, METOCLOPRAMIDE HYDROCHLORIDE

REGLAN, METOCLOPRAMIDE HYDROCHLORIDE

ROWASA, MESALAMINE

SFROWASA, MESALAMINE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 9

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

ALCON

* ALCON INC

AZOPT, BRINZOLAMIDE

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

CILOXAN, CIPROFLOXACIN HYDROCHLORIDE

CIPRO HC, CIPROFLOXACIN HYDROCHLORIDE

CIPRODEX, CIPROFLOXACIN

DICLOFENAC SODIUM, DICLOFENAC SODIUM

FLUORESCITE, FLUORESCEIN SODIUM

KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)

NAVSTEL, CALCIUM CHLORIDE

NEVANAC, NEPAFENAC

OFLOXACIN, OFLOXACIN

PATADAY, OLOPATADINE HYDROCHLORIDE

PATANASE, OLOPATADINE HYDROCHLORIDE

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TRAVATAN Z, TRAVOPROST

TRAVATAN, TRAVOPROST

TRIESENCE, TRIAMCINOLONE ACETONIDE

VIGAMOX, MOXIFLOXACIN HYDROCHLORIDE

* ALCON LABORATORIES INC

ALCAINE, PROPARACAINE HYDROCHLORIDE

ALOMIDE, LODOXAMIDE TROMETHAMINE

BETADINE, POVIDONE-IODINE

BETOPTIC S, BETAXOLOL HYDROCHLORIDE

BETOPTIC, BETAXOLOL HYDROCHLORIDE

BSS PLUS, CALCIUM CHLORIDE

BSS, CALCIUM CHLORIDE

CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE

CETAMIDE, SULFACETAMIDE SODIUM

CROMOLYN SODIUM, CROMOLYN SODIUM

CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE

CYCLOMYDRIL, CYCLOPENTOLATE HYDROCHLORIDE

DENDRID, IDOXURIDINE

EMADINE, EMEDASTINE DIFUMARATE

FLAREX, FLUOROMETHOLONE ACETATE

IOPIDINE, APRACLONIDINE HYDROCHLORIDE

ISOPTO CETAMIDE, SULFACETAMIDE SODIUM

MAXIDEX, DEXAMETHASONE

MAXITROL, DEXAMETHASONE

MIOSTAT, CARBACHOL

MYDRIACYL, TROPICAMIDE

NAPHCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)

NATACYN, NATAMYCIN

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE

OMNIPRED, PREDNISOLONE ACETATE

PATANOL, OLOPATADINE HYDROCHLORIDE

PILOPINE HS, PILOCARPINE HYDROCHLORIDE

TOBRADEX, DEXAMETHASONE

TOBRASONE, FLUOROMETHOLONE ACETATE

TOBREX, TOBRAMYCIN

TRIFLURIDINE, TRIFLURIDINE

VEXOL, RIMEXOLONE

ALCON RES

* ALCON RESEARCH LTD

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

ALCON UNIVERSAL

* ALCON UNIVERSAL LTD

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 10

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

ALEMBIC LTD

* ALEMBIC LTD

LITHIUM CARBONATE, LITHIUM CARBONATE

ALKERMES

* ALKERMES INC

VIVITROL, NALTREXONE

ALLEGIANCE HLTHCARE

* ALLEGIANCE HEALTHCARE CORP

POVIDONE IODINE, POVIDONE-IODINE (OTC)

ALLERGAN

* ALLERGAN

ACULAR LS, KETOROLAC TROMETHAMINE

ALPHAGAN P, BRIMONIDINE TARTRATE

BLEPH-10, SULFACETAMIDE SODIUM

GENOPTIC, GENTAMICIN SULFATE

* ALLERGAN INC

ACULAR PRESERVATIVE FREE, KETOROLAC TROMETHAMINE

ACULAR, KETOROLAC TROMETHAMINE

ACZONE, DAPSONE

ALBALON, NAPHAZOLINE HYDROCHLORIDE

ALOCRIL, NEDOCROMIL SODIUM

ALPHAGAN P, BRIMONIDINE TARTRATE

AVAGE, TAZAROTENE

AZELEX, AZELAIC ACID

COMBIGAN, BRIMONIDINE TARTRATE

ELESTAT, EPINASTINE HYDROCHLORIDE

ELIMITE, PERMETHRIN

LATISSE, BIMATOPROST

LUMIGAN, BIMATOPROST

OCUFLOX, OFLOXACIN

OPTICROM, CROMOLYN SODIUM

POLYTRIM, POLYMYXIN B SULFATE

RESTASIS, CYCLOSPORINE

TAZORAC, TAZAROTENE

TRIVARIS, TRIAMCINOLONE ACETONIDE

ZYMAR, GATIFLOXACIN

* ALLERGAN PHARMACEUTICAL

BETAGAN, LEVOBUNOLOL HYDROCHLORIDE

BLEPHAMIDE S.O.P., PREDNISOLONE ACETATE

BLEPHAMIDE, PREDNISOLONE ACETATE

FML FORTE, FLUOROMETHOLONE

FML, FLUOROMETHOLONE

HERPLEX, IDOXURIDINE

OCUFEN, FLURBIPROFEN SODIUM

OPHTHETIC, PROPARACAINE HYDROCHLORIDE

POLY-PRED, NEOMYCIN SULFATE

PRED FORTE, PREDNISOLONE ACETATE

PRED MILD, PREDNISOLONE ACETATE

PRED-G, GENTAMICIN SULFATE

PROPINE, DIPIVEFRIN HYDROCHLORIDE

ALLERGAN HERBERT

* ALLERGAN HERBERT SKIN CARE DIV ALLERGAN INC

FLUOROPLEX, FLUOROURACIL

ALPHAPHARM

* ALPHAPHARM PARTY LTD

ALPRAZOLAM, ALPRAZOLAM

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

BACLOFEN, BACLOFEN

CILOSTAZOL, CILOSTAZOL

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLONAZEPAM, CLONAZEPAM

DICLOFENAC SODIUM, DICLOFENAC SODIUM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 11

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ALPHAPHARM PARTY LTD

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GLIPIZIDE, GLIPIZIDE

INDAPAMIDE, INDAPAMIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

NAPROXEN, NAPROXEN

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRIAZOLAM, TRIAZOLAM

ZONISAMIDE, ZONISAMIDE

* ALPHAPHARM PTY LTD

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

ALPHARMA

* ALPHARMA USPD INC

PREDNISOLONE, PREDNISOLONE

VALPROIC ACID, VALPROIC ACID

ALPHARMA US PHARMS

* ALPHARMA US PHARMACEUTICALS DIVISION

ERYTHROMYCIN ESTOLATE, ERYTHROMYCIN ESTOLATE

ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

ALRA

* ALRA LABORATORIES INC

CHOLAC, LACTULOSE

CONSTILAC, LACTULOSE

ERYZOLE, ERYTHROMYCIN ETHYLSUCCINATE

GEN-XENE, CLORAZEPATE DIPOTASSIUM

IBU-TAB 200, IBUPROFEN (OTC)

IBU-TAB, IBUPROFEN

K+10, POTASSIUM CHLORIDE

K+8, POTASSIUM CHLORIDE

ALTANA

* ALTANA INC

ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE

AMCINONIDE, AMCINONIDE

BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC

BACITRACIN, BACITRACIN

BACITRACIN-NEOMYCIN-POLYMYXIN, BACITRACIN ZINC

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CHLORAMPHENICOL, CHLORAMPHENICOL

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CUTIVATE, FLUTICASONE PROPIONATE

DESONIDE, DESONIDE

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

ECONAZOLE NITRATE, ECONAZOLE NITRATE

ERYTHROMYCIN, ERYTHROMYCIN

FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE

FLUOCINONIDE, FLUOCINONIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

HYDROCORTISONE, HYDROCORTISONE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 12

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ALTANA INC

KETOCONAZOLE, KETOCONAZOLE

LIDOCAINE AND PRILOCAINE, LIDOCAINE

METRONIDAZOLE, METRONIDAZOLE

MOMETASONE FUROATE, MOMETASONE FUROATE

MUPIROCIN, MUPIROCIN

NYSTATIN, NYSTATIN

OXISTAT, OXICONAZOLE NITRATE

PREDNICARBATE, PREDNICARBATE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TEMOVATE E, CLOBETASOL PROPIONATE

TEMOVATE, CLOBETASOL PROPIONATE

TERCONAZOLE, TERCONAZOLE

TOBRAMYCIN, TOBRAMYCIN

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

ALTANA PHARMA

* ALTANA PHARMA AG

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

ALTERNA-TCHP LLC

* ALTERNA-TCHP LLC

CHILDREN'S ELIXSURE, IBUPROFEN (OTC)

ALZA

* ALZA CORP

SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)

AM ANTIBIOTICS

* AMERICAN ANTIBIOTICS LLC

AMOXICILLIN, AMOXICILLIN

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

AMAG PHARMS INC

* AMAG PHARMACEUTICALS INC

FERIDEX I.V., FERUMOXIDES

GASTROMARK, FERUMOXSIL

AMGEN

* AMGEN INC

SENSIPAR, CINACALCET HYDROCHLORIDE

AMIDE PHARM

* ACTAVIS TOTOWA LLC

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

AMNEAL PHARM

* AMNEAL PHARMACEUTICAL

ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

PRIMIDONE, PRIMIDONE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

AMNEAL PHARMS

* AMNEAL PHARMACEUTICALS

RANITIDINE, RANITIDINE HYDROCHLORIDE

* AMNEAL PHARMACEUTICALS LLC

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

AMNEAL PHARMS NY

* AMNEAL PHARMACEUTICALS NY LLC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ALPRAZOLAM, ALPRAZOLAM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 13

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AMNEAL PHARMACEUTICALS NY LLC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

GABAPENTIN, GABAPENTIN

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NAPROXEN, NAPROXEN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

REPREXAIN, HYDROCODONE BITARTRATE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

AMPHASTAR

* AMPHASTAR PHARMACEUTICALS INC

CORTROSYN, COSYNTROPIN

AMPHASTAR PHARM

* AMPHASTAR PHARMACEUTICAL INC

AMPHADASE, HYALURONIDASE

AMYLIN

* AMYLIN PHARMACEUTICALS INC

BYETTA, EXENATIDE SYNTHETIC

SYMLIN, PRAMLINTIDE ACETATE

ANBEX

* ANBEX INC

IOSAT, POTASSIUM IODIDE (OTC)

ANCHEN PHARMS

* ANCHEN PHARMACEUTICALS INC

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

* ANCHEN PHARMACEUTICALS TAIWAN INC

DIVALPROEX SODIUM, DIVALPROEX SODIUM

ANDAPHARM

* ANDAPHARM LLC

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

ANDRX LABS LLC

* ANDRX LABS LLC

ALTOPREV, LOVASTATIN

FORTAMET, METFORMIN HYDROCHLORIDE

ANESIVA

* ANESIVA INC

ZINGO, LIDOCAINE HYDROCHLORIDE

ANESTA

* ANESTA CORP

AMRIX, CYCLOBENZAPRINE HYDROCHLORIDE

ANI PHARMS

* ANI PHARMACEUTICALS INC

CORTENEMA, HYDROCORTISONE

ANI PHARMS INC

* ANI PHARMACEUTICALS INC

LACTULOSE, LACTULOSE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

ANTISOMA

* ANTISOMA

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 14

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

APOTEX

* APOTEX CORP

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

* APOTEX INC

ALENDRONATE SODIUM, ALENDRONATE SODIUM

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

EPLERENONE, EPLERENONE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

OMEPRAZOLE, OMEPRAZOLE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

RAMIPRIL, RAMIPRIL

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

APOTEX CORP

* APOTEX CORP

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

CICLOPIROX, CICLOPIROX

CLARITHROMYCIN, CLARITHROMYCIN

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

APOTEX INC

* APOTEX INC

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALPRAZOLAM, ALPRAZOLAM

CALCITONIN-SALMON, CALCITONIN, SALMON

CARBIDOPA AND LEVODOPA, CARBIDOPA

CEFPROZIL, CEFPROZIL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

LOVASTATIN, LOVASTATIN

MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE

OFLOXACIN, OFLOXACIN

OXCARBAZEPINE, OXCARBAZEPINE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* APOTEX INC ETOBICOKE SITE

ACYCLOVIR, ACYCLOVIR

ALLOPURINOL, ALLOPURINOL

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CARBAMAZEPINE, CARBAMAZEPINE

CARVEDILOL, CARVEDILOL

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CILOSTAZOL, CILOSTAZOL

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DILTZAC, DILTIAZEM HYDROCHLORIDE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

ETODOLAC, ETODOLAC

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 15

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* APOTEX INC ETOBICOKE SITE

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

GABAPENTIN, GABAPENTIN

KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)

LEFLUNOMIDE, LEFLUNOMIDE

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LITHIUM CARBONATE, LITHIUM CARBONATE

LORATADINE, LORATADINE (OTC)

MELOXICAM, MELOXICAM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

OXAPROZIN, OXAPROZIN

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

TORSEMIDE, TORSEMIDE

ZONISAMIDE, ZONISAMIDE

* APOTEX INC RICHMOND HILL

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK), FAMOTIDINE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUMAZENIL, FLUMAZENIL

FLUNISOLIDE, FLUNISOLIDE

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HALOPERIDOL, HALOPERIDOL LACTATE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LORATADINE, LORATADINE (OTC)

MEGESTROL ACETATE, MEGESTROL ACETATE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE

MILRINONE LACTATE IN DEXTROSE 5%, MILRINONE LACTATE

MILRINONE LACTATE, MILRINONE LACTATE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

PREDNISOLONE, PREDNISOLONE

VALPROIC ACID, VALPROIC ACID

APOTHECON

* APOTHECON INC DIV BRISTOL MYERS SQUIBB

CAPOZIDE 25/15, CAPTOPRIL

CAPOZIDE 25/25, CAPTOPRIL

CAPOZIDE 50/15, CAPTOPRIL

CAPOZIDE 50/25, CAPTOPRIL

FUNGIZONE, AMPHOTERICIN B

KENALOG, TRIAMCINOLONE ACETONIDE

KENALOG-10, TRIAMCINOLONE ACETONIDE

KENALOG-40, TRIAMCINOLONE ACETONIDE

KLOTRIX, POTASSIUM CHLORIDE

OPHTHAINE, PROPARACAINE HYDROCHLORIDE

PRINCIPEN, AMPICILLIN/AMPICILLIN TRIHYDRATE

STADOL PRESERVATIVE FREE, BUTORPHANOL TARTRATE

STADOL, BUTORPHANOL TARTRATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 16

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* APOTHECON INC DIV BRISTOL MYERS SQUIBB

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TRIMOX, AMOXICILLIN

VEETIDS, PENICILLIN V POTASSIUM

APOTHEKERNES

* APOTHEKERNES LABORATORIUM A/S

BACITRACIN, BACITRACIN

APP PHARMS

* APP PHARMACEUTICALS

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

PROTAMINE SULFATE, PROTAMINE SULFATE

* APP PHARMACEUTICALS LLC

CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC

COLISTIMETHATE, COLISTIMETHATE

EMLA, LIDOCAINE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HALOPERIDOL, HALOPERIDOL LACTATE

HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

NAROPIN, ROPIVACAINE HYDROCHLORIDE MONOHYDRATE

NEBUPENT, PENTAMIDINE ISETHIONATE

NESACAINE, CHLOROPROCAINE HYDROCHLORIDE

NESACAINE-MPF, CHLOROPROCAINE HYDROCHLORIDE

OXYTOCIN, OXYTOCIN

PENTAM, PENTAMIDINE ISETHIONATE

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

SENSORCAINE, BUPIVACAINE HYDROCHLORIDE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

XYLOCAINE 4% PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

XYLOCAINE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

XYLOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE

XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE

XYLOCAINE, LIDOCAINE HYDROCHLORIDE

AR HOLDING CO INC

* AR HOLDING CO INC

QUALAQUIN, QUININE SULFATE

ARMSTRONG PHARMS

* ARMSTRONG PHARMACEUTICALS INC

ALBUTEROL, ALBUTEROL

EPINEPHRINE, EPINEPHRINE (OTC)

ASCEND

* ASCEND THERAPEUTICS INC

ESTROGEL, ESTRADIOL

ASCENT PEDS

* ASCENT PEDIATRICS INC

ORAPRED, PREDNISOLONE SODIUM PHOSPHATE

ASTELLAS

* ASTELLAS PHARMA US INC

ADENOCARD, ADENOSINE

ADENOSCAN, ADENOSINE

AMBISOME, AMPHOTERICIN B

LEXISCAN, REGADENOSON

MYCAMINE, MICAFUNGIN SODIUM

PROGRAF, TACROLIMUS

PROTOPIC, TACROLIMUS

VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, CONIVAPTAN HYDROCHLORIDE

VAPRISOL, CONIVAPTAN HYDROCHLORIDE

VESICARE, SOLIFENACIN SUCCINATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 17

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

ASTRAZENECA

* ASTRAZENECA LP

ENTOCORT EC, BUDESONIDE

FOSCAVIR, FOSCARNET SODIUM

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE

NEXIUM IV, ESOMEPRAZOLE SODIUM

NEXIUM, ESOMEPRAZOLE MAGNESIUM

PRILOSEC OTC, OMEPRAZOLE MAGNESIUM (OTC)

PRILOSEC, OMEPRAZOLE

PRILOSEC, OMEPRAZOLE MAGNESIUM

PULMICORT FLEXHALER, BUDESONIDE

PULMICORT RESPULES, BUDESONIDE

RHINOCORT, BUDESONIDE

SEROQUEL, QUETIAPINE FUMARATE

SYMBICORT, BUDESONIDE

TENORMIN, ATENOLOL

TOPROL-XL, METOPROLOL SUCCINATE

* ASTRAZENECA PHARMACEUTICALS LP

ATACAND HCT, CANDESARTAN CILEXETIL

ATACAND, CANDESARTAN CILEXETIL

FASLODEX, FULVESTRANT

LEXXEL, ENALAPRIL MALEATE

PLENDIL, FELODIPINE

PULMICORT, BUDESONIDE

SEROQUEL XR, QUETIAPINE FUMARATE

TENORETIC 100, ATENOLOL

TENORETIC 50, ATENOLOL

ZOMIG, ZOLMITRIPTAN

ZOMIG-ZMT, ZOLMITRIPTAN

* ASTRAZENECA UK LTD

ACCOLATE, ZAFIRLUKAST

ARIMIDEX, ANASTROZOLE

CASODEX, BICALUTAMIDE

IRESSA, GEFITINIB

MERREM I.V., MEROPENEM

ZESTORETIC, HYDROCHLOROTHIAZIDE

ZESTRIL, LISINOPRIL

ZOLADEX, GOSERELIN ACETATE

ATON

* ATON PHARMA INC

CUPRIMINE, PENICILLAMINE

DEMSER, METYROSINE

EDECRIN, ETHACRYNATE SODIUM

EDECRIN, ETHACRYNIC ACID

LACRISERT, HYDROXYPROPYL CELLULOSE

MEPHYTON, PHYTONADIONE

SYPRINE, TRIENTINE HYDROCHLORIDE

AUROBINDO

* AUROBINDO PHARMA LTD

AMOXICILLIN, AMOXICILLIN

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

ZIDOVUDINE, ZIDOVUDINE

AUROBINDO PHARM

* AUROBINDO PHARMA USA INC

GABAPENTIN, GABAPENTIN

LEVETIRACETAM, LEVETIRACETAM

AUROBINDO PHARMA

* AUROBINDO PHARMA LTD

ALENDRONATE SODIUM, ALENDRONATE SODIUM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 18

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AUROBINDO PHARMA LTD

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMOXICILLIN, AMOXICILLIN

ATENOLOL, ATENOLOL

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

CARVEDILOL, CARVEDILOL

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFDINIR, CEFDINIR

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFPROZIL, CEFPROZIL

CEFTRIAXONE, CEFTRIAXONE SODIUM

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DIDANOSINE, DIDANOSINE

FINASTERIDE, FINASTERIDE

FLUCONAZOLE, FLUCONAZOLE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GLYBURIDE, GLYBURIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LEVETIRACETAM, LEVETIRACETAM

MELOXICAM, MELOXICAM

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

RISPERIDONE, RISPERIDONE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

STAVUDINE, STAVUDINE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TORSEMIDE, TORSEMIDE

TRANDOLAPRIL, TRANDOLAPRIL

ZALEPLON, ZALEPLON

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

AUROBINDO PHARMA LTD

* AUROBINDO PHARMA LTD INC

CEFPROZIL, CEFPROZIL

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEPHALEXIN, CEPHALEXIN

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

MIRTAZAPINE, MIRTAZAPINE

ZIDOVUDINE, ZIDOVUDINE

AUROSAL PHARMS

* AUROSAL PHARMACEUTICALS LLC

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AUXILIUM PHARMS

* AUXILIUM PHARMACEUTICALS

TESTIM, TESTOSTERONE

AVEVA

* AVEVA DRUG DELIVERY SYSTEMS INC

NICOTINE, NICOTINE (OTC)

PROSTEP, NICOTINE (OTC)

AXCAN

* AXCAN PHARMA US INC

BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE

BENTYL, DICYCLOMINE HYDROCHLORIDE

CARAFATE, SUCRALFATE

URSO 250, URSODIOL

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 19

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AXCAN PHARMA US INC

URSO FORTE, URSODIOL

AXCAN SCANDIPHARM

* AXCAN SCANDIPHARM INC

CANASA, MESALAMINE

PHOTOFRIN, PORFIMER SODIUM

PYLERA, BISMUTH SUBCITRATE POTASSIUM

AZUR PHARMA

* AZUR PHARMA INTERNATIONAL LTD

AVC, SULFANILAMIDE

GASTROCROM, CROMOLYN SODIUM

AZUR PHARMA II

* AZUR PHARMA INTERNATIONAL II LTD

ELESTRIN, ESTRADIOL

AZUR PHARMA INTL

* AZUR PHARMA INTERNATIONAL III LTD

FAZACLO ODT, CLOZAPINE

B BRAUN

* B BRAUN MEDICAL INC

ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL

ALCOHOL 10% AND DEXTROSE 5%, ALCOHOL

ALCOHOL 5% AND DEXTROSE 5%, ALCOHOL

BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER, BRETYLIUM TOSYLATE

CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM

CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER, CEFOTETAN DISODIUM

CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, CEFOXITIN SODIUM

CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM

CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM

DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%, DOPAMINE HYDROCHLORIDE

FREAMINE HBC 6.9%, AMINO ACIDS

FREAMINE III 10%, AMINO ACIDS

FREAMINE III 3% W/ ELECTROLYTES, AMINO ACIDS

FREAMINE III 8.5% W/ ELECTROLYTES, AMINO ACIDS

FREAMINE III 8.5%, AMINO ACIDS

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 20

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* B BRAUN MEDICAL INC

GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPATAMINE 8%, AMINO ACIDS

ISOLYTE E IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

ISOLYTE E IN PLASTIC CONTAINER, CALCIUM CHLORIDE

ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

HYDROCHLORIDE

MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER, MANNITOL

MANNITOL 10%, MANNITOL

MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%, MANNITOL

MANNITOL 15%, MANNITOL

MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 20%, MANNITOL

MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%, MANNITOL

MANNITOL 5%, MANNITOL

METRO I.V. IN PLASTIC CONTAINER, METRONIDAZOLE

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE

NEPHRAMINE 5.4%, AMINO ACIDS

NUTRILIPID 10%, SOYBEAN OIL

NUTRILIPID 20%, SOYBEAN OIL

PHYSIOLYTE IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC

CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 21

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* B BRAUN MEDICAL INC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 22

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* B BRAUN MEDICAL INC

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PROCALAMINE, AMINO ACIDS

RESECTISOL IN PLASTIC CONTAINER, MANNITOL

RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE

SORBITOL 3.3% IN PLASTIC CONTAINER, SORBITOL

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, WATER FOR INJECTION, STERILE

STERILE WATER IN PLASTIC CONTAINER, WATER FOR IRRIGATION, STERILE

THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

TROPHAMINE 10%, AMINO ACIDS

TROPHAMINE, AMINO ACIDS

BALLARD MEDCL

* BALLARD MEDICAL PRODUCTS INC

PYTEST KIT, UREA, C-14

PYTEST, UREA, C-14

BANNER PHARMACAPS

* BANNER PHARMACAPS INC

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

BENZONATATE, BENZONATATE

ETHOSUXIMIDE, ETHOSUXIMIDE

IBUPROFEN, IBUPROFEN (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NIMODIPINE, NIMODIPINE

STAVZOR, VALPROIC ACID

VALPROIC ACID, VALPROIC ACID

VITAMIN D, ERGOCALCIFEROL

ZONISAMIDE, ZONISAMIDE

BARR

* BARR LABORATORIES INC

ALENDRONATE SODIUM, ALENDRONATE SODIUM

ALPRAZOLAM, ALPRAZOLAM

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

ARANELLE, ETHINYL ESTRADIOL

BALZIVA-21, ETHINYL ESTRADIOL

BALZIVA-28, ETHINYL ESTRADIOL

CABERGOLINE, CABERGOLINE

CAMILA, NORETHINDRONE

CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CHLORZOXAZONE, CHLORZOXAZONE

CLARAVIS, ISOTRETINOIN

CLONAZEPAM, CLONAZEPAM

DANAZOL, DANAZOL

DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 23

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BARR LABORATORIES INC

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

ASPARTATE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DIAZEPAM, DIAZEPAM

DIDANOSINE, DIDANOSINE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

ERRIN, NORETHINDRONE

ESTRADIOL AND NORGESTIMATE, ESTRADIOL

ESTRADIOL, ESTRADIOL

ESTROPIPATE, ESTROPIPATE

ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUTAMIDE, FLUTAMIDE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

ISONIAZID, ISONIAZID

JUNEL 1.5/30, ETHINYL ESTRADIOL

JUNEL 1/20, ETHINYL ESTRADIOL

JUNEL FE 1.5/30, ETHINYL ESTRADIOL

JUNEL FE 1/20, ETHINYL ESTRADIOL

KARIVA, DESOGESTREL

KELNOR, ETHINYL ESTRADIOL

LEFLUNOMIDE, LEFLUNOMIDE

LESSINA-28, ETHINYL ESTRADIOL

MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

MEFLOQUINE, MEFLOQUINE HYDROCHLORIDE

MEGESTROL ACETATE, MEGESTROL ACETATE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

MIRTAZAPINE, MIRTAZAPINE

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NIMODIPINE, NIMODIPINE

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

NORTREL 0.5/35-28, ETHINYL ESTRADIOL

NORTREL 1/35-21, ETHINYL ESTRADIOL

NORTREL 1/35-28, ETHINYL ESTRADIOL

NORTREL 7/7/7, ETHINYL ESTRADIOL

ONDANSETRON, ONDANSETRON

OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN

PORTIA-28, ETHINYL ESTRADIOL

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

SPRINTEC, ETHINYL ESTRADIOL

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRETINOIN, TRETINOIN

TREXALL, METHOTREXATE SODIUM

TRI-LEGEST 21, ETHINYL ESTRADIOL

TRI-LEGEST FE, ETHINYL ESTRADIOL

TRI-SPRINTEC, ETHINYL ESTRADIOL

WARFARIN SODIUM, WARFARIN SODIUM

ZONISAMIDE, ZONISAMIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 24

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BARR PHARMACEUTICALS

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

BARRIER

* BARRIER THERAPEUTICS

SOLAGE, MEQUINOL

VUSION, MICONAZOLE NITRATE

BARRIER THERAP

* BARRIER THERAPEUTICS INC

XOLEGEL, KETOCONAZOLE

BARTOR

* BARTOR PHARMACAL CO

TESTOSTERONE, TESTOSTERONE

BAUSCH AND LOMB

* BAUSCH AND LOMB INC

ALAWAY, KETOTIFEN FUMARATE (OTC)

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALREX, LOTEPREDNOL ETABONATE

CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

FLURBIPROFEN SODIUM, FLURBIPROFEN SODIUM

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LOTEMAX, LOTEPREDNOL ETABONATE

OFLOXACIN, OFLOXACIN

OPCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)

RETISERT, FLUOCINOLONE ACETONIDE

TIMOLOL MALEATE, TIMOLOL MALEATE

VITRASERT, GANCICLOVIR

ZYLET, LOTEPREDNOL ETABONATE

* BAUSCH AND LOMB PHARMACEUTICALS INC

ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE, ACETIC ACID, GLACIAL

BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CROLOM, CROMOLYN SODIUM

CROMOLYN SODIUM, CROMOLYN SODIUM

CROMOLYN SODIUM, CROMOLYN SODIUM (OTC)

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXASPORIN, DEXAMETHASONE

DIPIVEFRIN HYDROCHLORIDE, DIPIVEFRIN HYDROCHLORIDE

ERYTHROMYCIN, ERYTHROMYCIN

FLUNISOLIDE, FLUNISOLIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

NAFAZAIR, NAPHAZOLINE HYDROCHLORIDE

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC

NYSTATIN, NYSTATIN

OFLOXACIN, OFLOXACIN

OPTIPRANOLOL, METIPRANOLOL HYDROCHLORIDE

OTICAIR, HYDROCORTISONE

PENTOLAIR, CYCLOPENTOLATE HYDROCHLORIDE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TIMOLOL MALEATE, TIMOLOL MALEATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 25

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAUSCH AND LOMB PHARMACEUTICALS INC

TOBRAMYCIN AND DEXAMETHASONE, DEXAMETHASONE

TOBRAMYCIN, TOBRAMYCIN

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

TROPICAMIDE, TROPICAMIDE

BAXTER

* BAXTER HEALTHCARE CORP

CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE

PHENYTOIN SODIUM, PHENYTOIN SODIUM

BAXTER HLTHCARE

* BAXTER HEALTHCARE CORP

ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL

ADENOSINE, ADENOSINE

AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER, GLYCINE

ANCEF IN PLASTIC CONTAINER, CEFAZOLIN SODIUM

BACTOCILL IN PLASTIC CONTAINER, OXACILLIN SODIUM

BRANCHAMIN 4% IN PLASTIC CONTAINER, AMINO ACIDS

CARDIOPLEGIC IN PLASTIC CONTAINER, CALCIUM CHLORIDE

CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC

CONTAINER, AMINO ACIDS

CLINIMIX E 2.75/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC

CONTAINER, AMINO ACIDS

CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,

AMINO ACIDS

CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC

CONTAINER, AMINO ACIDS

CLINIMIX E 4.25/20 SULFITE-FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC

CONTAINER, AMINO ACIDS

CLINIMIX E 4.25/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC

CONTAINER, AMINO ACIDS

CLINIMIX E 4.25/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,

AMINO ACIDS

CLINIMIX E 5/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER,

AMINO ACIDS

CLINIMIX E 5/15 SULFITE-FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER,

AMINO ACIDS

CLINIMIX E 5/20 SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER,

AMINO ACIDS

CLINIMIX E 5/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER,

AMINO ACIDS

CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER,

AMINO ACIDS

DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 26

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAXTER HEALTHCARE CORP

DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER,

DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER,

DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER,

DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER,

DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER,

DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER,

DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC

CONTAINER, DEXTROSE

DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 60% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE

DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE

EXTRANEAL, ICODEXTRIN

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE

FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPATASOL 8%, AMINO ACIDS

ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER, GENTAMICIN SULFATE

LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

HYDROCHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 27

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAXTER HEALTHCARE CORP

MESNEX, MESNA

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE

NALLPEN IN PLASTIC CONTAINER, NAFCILLIN SODIUM

NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN

ONDANSETRON HYDROCHLORIDE AND SODIUM CHLORIDE IN PLASTIC CONTAINER, ONDANSETRON

HYDROCHLORIDE

OSMITROL 10% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 10% IN WATER, MANNITOL

OSMITROL 15% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 15% IN WATER, MANNITOL

OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 20% IN WATER, MANNITOL

OSMITROL 5% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 5% IN WATER, MANNITOL

PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, PENICILLIN G POTASSIUM

PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

PLASMA-LYTE 56 IN PLASTIC CONTAINER, MAGNESIUM ACETATE TETRAHYDRATE

PLASMA-LYTE A IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PLASMA-LYTE R IN PLASTIC CONTAINER, CALCIUM CHLORIDE

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM

CHLORIDE

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

CALCIUM CHLORIDE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

CALCIUM CHLORIDE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

CALCIUM CHLORIDE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

CALCIUM CHLORIDE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

CALCIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

CALCIUM CHLORIDE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PREMASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS

PREMASOL 6% IN PLASTIC CONTAINER, AMINO ACIDS

RENAMIN W/O ELECTROLYTES, AMINO ACIDS

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 28

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAXTER HEALTHCARE CORP

RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

SEVOFLURANE, SEVOFLURANE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE

SORBITOL 3% IN PLASTIC CONTAINER, SORBITOL

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, WATER FOR INJECTION, STERILE

STERILE WATER IN PLASTIC CONTAINER, WATER FOR IRRIGATION, STERILE

STERILE WATER, WATER FOR IRRIGATION, STERILE

THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

TIS-U-SOL IN PLASTIC CONTAINER, MAGNESIUM SULFATE

TIS-U-SOL, MAGNESIUM SULFATE

TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS

TRAVASOL 10% W/O ELECTROLYTES, AMINO ACIDS

TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS

TRAVASOL 3.5% W/ ELECTROLYTES, AMINO ACIDS

TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS

TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS

TRAVASOL 5.5% W/ ELECTROLYTES, AMINO ACIDS

TRAVASOL 5.5% W/O ELECTROLYTES, AMINO ACIDS

TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS

TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS

TRAVASOL 8.5% W/ ELECTROLYTES, AMINO ACIDS

TRAVASOL 8.5% W/O ELECTROLYTES, AMINO ACIDS

VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE

* BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE

ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE, ACYCLOVIR SODIUM

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

BUMETANIDE, BUMETANIDE

CEFOXITIN, CEFOXITIN SODIUM

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DIGOXIN, DIGOXIN

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

DOPRAM, DOXAPRAM HYDROCHLORIDE

DURAMORPH PF, MORPHINE SULFATE

ERYTHROMYCIN LACTOBIONATE, ERYTHROMYCIN LACTOBIONATE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE

FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE

FLUMAZENIL, FLUMAZENIL

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

FUROSEMIDE, FUROSEMIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HEPARIN SODIUM, HEPARIN SODIUM

INFUMORPH, MORPHINE SULFATE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE, MILRINONE LACTATE

MITOMYCIN, MITOMYCIN

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

ROBINUL, GLYCOPYRROLATE

SUFENTANIL CITRATE, SUFENTANIL CITRATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 29

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

* BAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV

FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE

PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS

BAXTER HLTHCARE CORP

* BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE

AMRINONE LACTATE, INAMRINONE LACTATE

ATIVAN, LORAZEPAM

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

BREVIBLOC, ESMOLOL HYDROCHLORIDE

ETHRANE, ENFLURANE

FORANE, ISOFLURANE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE, MILRINONE LACTATE

OXYTOCIN, OXYTOCIN

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE

REGLAN, METOCLOPRAMIDE HYDROCHLORIDE

ROBAXIN, METHOCARBAMOL

SUPRANE, DESFLURANE

BAYER

* BAYER HEALTHCARE LLC

ALEVE, NAPROXEN SODIUM (OTC)

ALEVE-D SINUS & COLD, NAPROXEN SODIUM (OTC)

BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN, ASPIRIN (OTC)

FEMSTAT 3, BUTOCONAZOLE NITRATE (OTC)

BAYER HLTHCARE

* BAYER HEALTHCARE PHARMACEUTICALS INC

ANGELIQ, DROSPIRENONE

BETAPACE AF, SOTALOL HYDROCHLORIDE

BETAPACE, SOTALOL HYDROCHLORIDE

CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CIPRO XR, CIPROFLOXACIN

CIPRO, CIPROFLOXACIN

CIPRO, CIPROFLOXACIN HYDROCHLORIDE

CLIMARA PRO, ESTRADIOL

CLIMARA, ESTRADIOL

DTIC-DOME, DACARBAZINE

EOVIST, GADOXETATE DISODIUM

FLUDARA, FLUDARABINE PHOSPHATE

LEVITRA, VARDENAFIL HYDROCHLORIDE

LEVLITE, ETHINYL ESTRADIOL

MAGNEVIST, GADOPENTETATE DIMEGLUMINE

MENOSTAR, ESTRADIOL

MIRENA, LEVONORGESTREL

MYCELEX, CLOTRIMAZOLE

PRECOSE, ACARBOSE

REFLUDAN, LEPIRUDIN RECOMBINANT

TRASYLOL, APROTININ

ULTRAVIST (PHARMACY BULK), IOPROMIDE

ULTRAVIST 150, IOPROMIDE

ULTRAVIST 240, IOPROMIDE

ULTRAVIST 300 IN PLASTIC CONTAINER, IOPROMIDE

ULTRAVIST 300, IOPROMIDE

ULTRAVIST 370, IOPROMIDE

YASMIN, DROSPIRENONE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 30

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAYER HEALTHCARE PHARMACEUTICALS INC

YAZ, DROSPIRENONE

BAYER PHARMS

* BAYER PHARMACEUTICALS CORP

ADALAT CC, NIFEDIPINE

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN HYDROCHLORIDE

AVELOX, MOXIFLOXACIN HYDROCHLORIDE

BILTRICIDE, PRAZIQUANTEL

MYCELEX-7 COMBINATION PACK, CLOTRIMAZOLE (OTC)

MYCELEX-7, CLOTRIMAZOLE (OTC)

NEXAVAR, SORAFENIB TOSYLATE

NIMOTOP, NIMODIPINE

BEAUFOUR IPSEN

* BEAUFOUR IPSEN PHARMA

SOMATULINE DEPOT, LANREOTIDE ACETATE

BECTON DICKINSON

* BECTON DICKINSON AND CO

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC)

E-Z SCRUB 201, POVIDONE-IODINE (OTC)

E-Z SCRUB 241, POVIDONE-IODINE (OTC)

BEDFORD

* BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC

ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM

ACETYLCYSTEINE, ACETYLCYSTEINE

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM

ADENOSINE, ADENOSINE

ALPROSTADIL, ALPROSTADIL

AMIKACIN SULFATE, AMIKACIN SULFATE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMRINONE, INAMRINONE LACTATE

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

AZATHIOPRINE SODIUM, AZATHIOPRINE SODIUM

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

BUMETANIDE, BUMETANIDE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

CARBOPLATIN, CARBOPLATIN

CEFTRIAXONE, CEFTRIAXONE SODIUM

CERUBIDINE, DAUNORUBICIN HYDROCHLORIDE

CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CISPLATIN, CISPLATIN

CLADRIBINE, CLADRIBINE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CYCLOSPORINE, CYCLOSPORINE

CYTARABINE, CYTARABINE

DACARBAZINE, DACARBAZINE

DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE

DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE

DEXRAZOXANE, DEXRAZOXANE HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE), DICYCLOMINE HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE

DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE HYCLATE

ENALAPRILAT, ENALAPRILAT

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

ETOMIDATE, ETOMIDATE

ETOPOSIDE, ETOPOSIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 31

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE

FLOXURIDINE, FLOXURIDINE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

GANCICLOVIR SODIUM, GANCICLOVIR SODIUM

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HALOPERIDOL, HALOPERIDOL LACTATE

INDOMETHACIN SODIUM, INDOMETHACIN SODIUM

KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

LEVOCARNITINE, LEVOCARNITINE

LORAZEPAM, LORAZEPAM

MESNA, MESNA

METHOTREXATE PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOTREXATE SODIUM, METHOTREXATE SODIUM

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE, MILRINONE LACTATE

MITOMYCIN, MITOMYCIN

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PACLITAXEL, PACLITAXEL

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PHENTOLAMINE MESYLATE, PHENTOLAMINE MESYLATE

POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RIFAMPIN, RIFAMPIN

TERBUTALINE SULFATE, TERBUTALINE SULFATE

THIOTEPA, THIOTEPA

VALPROATE SODIUM, VALPROATE SODIUM

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

VINBLASTINE SULFATE, VINBLASTINE SULFATE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

BEDFORD LABS

* BEDFORD LABORATORIES

ALLOPURINOL SODIUM, ALLOPURINOL SODIUM

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

CARBOPLATIN, CARBOPLATIN

CIPROFLOXACIN, CIPROFLOXACIN

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUMAZENIL, FLUMAZENIL

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LORAZEPAM PRESERVATIVE FREE, LORAZEPAM

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 32

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BEDFORD LABORATORIES

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

PENTOSTATIN, PENTOSTATIN

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

TORSEMIDE, TORSEMIDE

* BEDFORD LABORATORIES INC

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

BEIJING DOUBLE CRANE

* BEIJING DOUBLE CRANE PHARMACEUTICAL CO LTD

MELOXICAM, MELOXICAM

BELCHER

* BELCHER PHARMACEUTICALS INC

CEPHALEXIN, CEPHALEXIN

BEN VENUE

* BEN VENUE LABORATORIES INC

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

BIO NUCLEONICS

* BIO NUCLEONICS INC

STRONTIUM CHLORIDE SR-89, STRONTIUM CHLORIDE, SR-89

BIOKEY

* BIOKEY INC

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BIOMARIN PHARM

* BIOMARIN PHARMACEUTICAL INC

KUVAN, SAPROPTERIN DIHYDROCHLORIDE

BIONICHE PHARMA

* BIONICHE PHARMA USA LLC

ALOPRIM, ALLOPURINOL SODIUM

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

DIMETHYL SULFOXIDE, DIMETHYL SULFOXIDE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

ENLON-PLUS, ATROPINE SULFATE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE

MEFOXIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM

MILRINONE LACTATE, MILRINONE LACTATE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RIMSO-50, DIMETHYL SULFOXIDE

SOTRADECOL, SODIUM TETRADECYL SULFATE

BIONICHE TEORANTA

* BIONICHE TEORANTA

ULTIVA, REMIFENTANIL HYDROCHLORIDE

BIOVAIL

* BIOVAIL CORP INTERNATIONAL

TIAZAC, DILTIAZEM HYDROCHLORIDE

* BIOVAIL LABORATORIES INC

ATIVAN, LORAZEPAM

CARDIZEM CD, DILTIAZEM HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

ISORDIL, ISOSORBIDE DINITRATE

NIFEDIPINE, NIFEDIPINE

PENTOXIFYLLINE, PENTOXIFYLLINE

BIOVAIL AMERICAS

* BIOVAIL AMERICAS CORP

XENAZINE, TETRABENAZINE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 33

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

BIOVAIL LABS INTL

* BIOVAIL LABORATORIES INTERNATIONAL SRL

APLENZIN, BUPROPION HYDROBROMIDE

CARDIZEM LA, DILTIAZEM HYDROCHLORIDE

CARDIZEM, DILTIAZEM HYDROCHLORIDE

ULTRAM ER, TRAMADOL HYDROCHLORIDE

VASERETIC, ENALAPRIL MALEATE

VASOTEC, ENALAPRIL MALEATE

VASOTEC, ENALAPRILAT

BLAIREX

* BLAIREX LABORATORIES INC

BRONCHO SALINE, SODIUM CHLORIDE (OTC)

BOCA PHARMA

* BOCA PHARMACAL INC

ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN

CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE

CO-LAV, POLYETHYLENE GLYCOL 3350

GO-EVAC, POLYETHYLENE GLYCOL 3350

HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%, HYDROCORTISONE ACETATE

METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE

BOEHRINGER INGELHEIM

* BOEHRINGER INGELHEIM

CATAPRES, CLONIDINE HYDROCHLORIDE

CATAPRES-TTS-1, CLONIDINE

CATAPRES-TTS-2, CLONIDINE

CATAPRES-TTS-3, CLONIDINE

MICARDIS HCT, HYDROCHLOROTHIAZIDE

MICARDIS, TELMISARTAN

MIRAPEX, PRAMIPEXOLE DIHYDROCHLORIDE

ZANTAC 150, RANITIDINE HYDROCHLORIDE (OTC)

ZANTAC 75, RANITIDINE HYDROCHLORIDE (OTC)

* BOEHRINGER INGELHEIM PHARMACEUTICALS INC

AGGRENOX, ASPIRIN

ALUPENT, METAPROTERENOL SULFATE

APTIVUS, TIPRANAVIR

ATROVENT HFA, IPRATROPIUM BROMIDE

ATROVENT, IPRATROPIUM BROMIDE

COMBIVENT, ALBUTEROL SULFATE

FLOMAX, TAMSULOSIN HYDROCHLORIDE

MOBIC, MELOXICAM

PERSANTINE, DIPYRIDAMOLE

SPIRIVA, TIOTROPIUM BROMIDE MONOHYDRATE

VIRAMUNE, NEVIRAPINE

BRACCO

* BRACCO DIAGNOSTICS INC

CARDIOGEN-82, RUBIDIUM CHLORIDE RB-82

CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT

CHOLOGRAFIN MEGLUMINE, IODIPAMIDE MEGLUMINE

CHROMITOPE SODIUM, SODIUM CHROMATE, CR-51

CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE

CYSTOGRAFIN, DIATRIZOATE MEGLUMINE

GASTROGRAFIN, DIATRIZOATE MEGLUMINE

ISOVUE-200, IOPAMIDOL

ISOVUE-250, IOPAMIDOL

ISOVUE-300, IOPAMIDOL

ISOVUE-370, IOPAMIDOL

ISOVUE-M 200, IOPAMIDOL

ISOVUE-M 300, IOPAMIDOL

KINEVAC, SINCALIDE

MDP-BRACCO, TECHNETIUM TC-99M MEDRONATE KIT

MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE

MULTIHANCE, GADOBENATE DIMEGLUMINE

PROHANCE MULTIPACK, GADOTERIDOL

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BRACCO DIAGNOSTICS INC

PROHANCE, GADOTERIDOL

RENO-30, DIATRIZOATE MEGLUMINE

RENO-60, DIATRIZOATE MEGLUMINE

RENO-DIP, DIATRIZOATE MEGLUMINE

RENOGRAFIN-60, DIATRIZOATE MEGLUMINE

RENOGRAFIN-76, DIATRIZOATE MEGLUMINE

SINOGRAFIN, DIATRIZOATE MEGLUMINE

BRAINTREE

* BRAINTREE LABORATORIES INC

AXID, NIZATIDINE

GOLYTELY, POLYETHYLENE GLYCOL 3350

HALFLYTELY, BISACODYL

NULYTELY, POLYETHYLENE GLYCOL 3350

NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350

BREATH LTD

* BREATH LTD

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

BRECKENRIDGE PHARM

* BRECKENRIDGE PHARMACEUTICAL INC

ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL

MELOXICAM, MELOXICAM

OXCARBAZEPINE, OXCARBAZEPINE

BRIGHTON PHARMS INC

* BRIGHTON PHARMACEUTICALS INC

BROMFED-DM, BROMPHENIRAMINE MALEATE

BRIGHTSTONE

* BRIGHTSTONE PHARMA INC

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

BRISTOL

* BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO

BICNU, CARMUSTINE

BRISTACYCLINE, TETRACYCLINE HYDROCHLORIDE

BRISTOL MYERS

* BRISTOL MYERS CO

MUTAMYCIN, MITOMYCIN

PLATINOL, CISPLATIN

PLATINOL-AQ, CISPLATIN

QUESTRAN LIGHT, CHOLESTYRAMINE

QUESTRAN, CHOLESTYRAMINE

BRISTOL MYERS SQUIBB

* BRISTOL MYERS SQUIBB

AZACTAM, AZTREONAM

BARACLUDE, ENTECAVIR

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

GLUCOVANCE, GLYBURIDE

LYSODREN, MITOTANE

MEGACE, MEGESTROL ACETATE

MONOPRIL-HCT, FOSINOPRIL SODIUM

PRAVACHOL, PRAVASTATIN SODIUM

* BRISTOL MYERS SQUIBB CO

AZACTAM IN PLASTIC CONTAINER, AZTREONAM

CEENU, LOMUSTINE

DROXIA, HYDROXYUREA

ESTRACE, ESTRADIOL

GLUCOPHAGE XR, METFORMIN HYDROCHLORIDE

HYDREA, HYDROXYUREA

IXEMPRA KIT, IXABEPILONE

METAGLIP, GLIPIZIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BRISTOL MYERS SQUIBB CO

MYCOSTATIN, NYSTATIN

PARAPLATIN, CARBOPLATIN

REYATAZ, ATAZANAVIR SULFATE

SPRYCEL, DASATINIB

SUSTIVA, EFAVIRENZ

VEPESID, ETOPOSIDE

VIDEX EC, DIDANOSINE

* BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE

BLENOXANE, BLEOMYCIN SULFATE

BUSPAR, BUSPIRONE HYDROCHLORIDE

CEFZIL, CEFPROZIL

ESTRACE, ESTRADIOL

ETOPOPHOS PRESERVATIVE FREE, ETOPOSIDE PHOSPHATE

GLUCOPHAGE, METFORMIN HYDROCHLORIDE

IFEX/MESNEX KIT, IFOSFAMIDE

LYOPHILIZED CYTOXAN, CYCLOPHOSPHAMIDE

MAXIPIME, CEFEPIME HYDROCHLORIDE

MONOPRIL, FOSINOPRIL SODIUM

TAXOL, PACLITAXEL

VIDEX, DIDANOSINE

VUMON, TENIPOSIDE

ZERIT, STAVUDINE

* BRISTOL MYERS SQUIBB PHARMA CO

COUMADIN, WARFARIN SODIUM

LODOSYN, CARBIDOPA

SINEMET CR, CARBIDOPA

SINEMET, CARBIDOPA

SUSTIVA, EFAVIRENZ

BRYAN

* BRYAN CORP

SCLEROSOL, TALC

TALC, TALC

C AND M PHARMA

* C AND M PHARMACAL INC

HI-COR, HYDROCORTISONE

CADISTA PHARMS

* CADISTA PHARMACEUTICALS INC

CARBAMAZEPINE, CARBAMAZEPINE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

FOLIC ACID, FOLIC ACID

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

INDAPAMIDE, INDAPAMIDE

METHYLPREDNISOLONE, METHYLPREDNISOLONE

PREDNISONE, PREDNISONE

PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

CANGENE

* CANGENE CORP

ACCRETROPIN, SOMATROPIN RECOMBINANT

CANYON

* CANYON PHARMACEUTICALS INC

IPRIVASK, DESIRUDIN RECOMBINANT

CARACO

* CARACO PHARMACEUTICAL LABORATORIES LTD

ALLOPURINOL, ALLOPURINOL

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ATENOLOL, ATENOLOL

BACLOFEN, BACLOFEN

CARBAMAZEPINE, CARBAMAZEPINE

CARVEDILOL, CARVEDILOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 36

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CARACO PHARMACEUTICAL LABORATORIES LTD

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE (OTC)

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLONAZEPAM, CLONAZEPAM

CLOZAPINE, CLOZAPINE

DIGOXIN, DIGOXIN

EQUAGESIC, ASPIRIN

FLURBIPROFEN, FLURBIPROFEN

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GLIPIZIDE, GLIPIZIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

MELOXICAM, MELOXICAM

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHIMAZOLE, METHIMAZOLE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MIRTAZAPINE, MIRTAZAPINE

OXAPROZIN, OXAPROZIN

PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

SYNALGOS-DC, ASPIRIN

TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

CARDINAL HLTH 116

* CARDINAL HEALTH 116 LLC

ALBUTEROL SULFATE, ALBUTEROL SULFATE

CARLSBAD

* CARLSBAD TECHNOLOGY INC

ACYCLOVIR, ACYCLOVIR

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

FAMOTIDINE, FAMOTIDINE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

LOVASTATIN, LOVASTATIN

MELOXICAM, MELOXICAM

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

CAROLINA MEDCL

* CAROLINA MEDICAL PRODUCTS CO

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

HYDROCORTISONE IN ABSORBASE, HYDROCORTISONE

ISONIAZID, ISONIAZID

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

SPS, SODIUM POLYSTYRENE SULFONATE

TRIAMCINOLONE ACETONIDE IN ABSORBASE, TRIAMCINOLONE ACETONIDE

CATALENT

* CATALENT PHARMA SOLUTIONS LLC

NIFEDIPINE, NIFEDIPINE

VALPROIC ACID, VALPROIC ACID

CEDAR PHARMS

* CEDAR PHARMACEUTICALS LLC

METHIMAZOLE, METHIMAZOLE

CELGENE

* CELGENE CORP

INNOHEP, TINZAPARIN SODIUM

REVLIMID, LENALIDOMIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CELGENE CORP

THALOMID, THALIDOMIDE

CEPH INTL

* CEPH INTERNATIONAL CORP

CEFACLOR, CEFACLOR

CEPHALEXIN, CEPHALEXIN

CEPHALON

* CEPHALON INC

ACTIQ, FENTANYL CITRATE

FENTORA, FENTANYL CITRATE

GABITRIL, TIAGABINE HYDROCHLORIDE

NUVIGIL, ARMODAFINIL

PROVIGIL, MODAFINIL

TREANDA, BENDAMUSTINE HYDROCHLORIDE

TRISENOX, ARSENIC TRIOXIDE

CEPHAZONE PHARMA

* CEPHAZONE PHARMA LLC

CEFTRIAXONE, CEFTRIAXONE SODIUM

CHATTEM

* CHATTEM INC

SELSUN, SELENIUM SULFIDE

UNISOM, DOXYLAMINE SUCCINATE (OTC)

CHIRHOCLIN

* CHIRHOCLIN INC

CHIRHOSTIM, SECRETIN SYNTHETIC HUMAN

CIPHER

* CIPHER PHARMACEUTICALS LTD

LIPOFEN, FENOFIBRATE

CIPLA

* CIPLA LTD

RAMIPRIL, RAMIPRIL

TRANDOLAPRIL, TRANDOLAPRIL

CIPLA LTD

* CIPLA LTD

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

ZALEPLON, ZALEPLON

ZIDOVUDINE, ZIDOVUDINE

CLARIS LIFESCIENCES

* CLARIS LIFESCIENCES LTD

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CIPROFLOXACIN, CIPROFLOXACIN

METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE

ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE

CLINTEC NUTR

* CLINTEC NUTRITION CO SUB CLINIQUE

CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS

CLONMEL

* CLONMEL HEALTHCARE

AMOXICILLIN, AMOXICILLIN

AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

CLONMEL HLTHCARE

* CLONMEL HEALTHCARE LTD

ACYCLOVIR, ACYCLOVIR

ATENOLOL, ATENOLOL

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

CIMETIDINE, CIMETIDINE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DIAZEPAM, DIAZEPAM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 38

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CLONMEL HEALTHCARE LTD

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

GLYBURIDE (MICRONIZED), GLYBURIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

NAPROXEN, NAPROXEN

PYRAZINAMIDE, PYRAZINAMIDE

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

COASTAL PHARMS

* COASTAL PHARMACEUTICALS INC

NYSTATIN, NYSTATIN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

COBALT

* COBALT PHARMACEUTICALS INC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

GLIMEPIRIDE, GLIMEPIRIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

TRANDOLAPRIL, TRANDOLAPRIL

COBALT LABS INC

* COBALT LABORATORIES INC

ACARBOSE, ACARBOSE

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

CABERGOLINE, CABERGOLINE

ISRADIPINE, ISRADIPINE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

RAMIPRIL, RAMIPRIL

RISPERIDONE, RISPERIDONE

COLGATE

* COLGATE ORAL PHARMACEUTICALS INC

ORABASE HCA, HYDROCORTISONE ACETATE

PERIOGARD, CHLORHEXIDINE GLUCONATE

COLGATE PALMOLIVE

* COLGATE PALMOLIVE

COLGATE TOTAL, SODIUM FLUORIDE (OTC)

COLUMBIA LABS

* COLUMBIA LABORATORIES INC

CRINONE, PROGESTERONE

STRIANT, TESTOSTERONE

CONCORD LABS NJ

* CONCORD LABORATORIES INC

BUTALBITAL ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

CARISOPRODOL, CARISOPRODOL

PROBENECID AND COLCHICINE, COLCHICINE

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, ACETAMINOPHEN

CONNETICS

* CONNETICS CORP

OLUX, CLOBETASOL PROPIONATE

CONTRACT PHARMA

* CONTRACT PHARMACAL CORP

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 39

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

CONTROLLED THERAP

* CONTROLLED THERAPEUTICS (SCOTLAND) LTD

CERVIDIL, DINOPROSTONE

COOK IMAGING

* COOK IMAGING CORP

IOPAMIDOL-200, IOPAMIDOL

IOPAMIDOL-250, IOPAMIDOL

IOPAMIDOL-300, IOPAMIDOL

IOPAMIDOL-370, IOPAMIDOL

COPLEY PHARM

* COPLEY PHARMACEUTICAL INC

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

COREPHARMA

* COREPHARMA LLC

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

ALPRAZOLAM, ALPRAZOLAM

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

CARISOPRODOL, CARISOPRODOL

CILOSTAZOL, CILOSTAZOL

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

ASPARTATE

DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

GLIMEPIRIDE, GLIMEPIRIDE

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GLYBURIDE, GLYBURIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

LEVOCARNITINE, LEVOCARNITINE

MELOXICAM, MELOXICAM

METHENAMINE HIPPURATE, METHENAMINE HIPPURATE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

POTASSIUM CITRATE, POTASSIUM CITRATE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRANDOLAPRIL, TRANDOLAPRIL

URSODIOL, URSODIOL

ZONISAMIDE, ZONISAMIDE

CORIA

* CORIA LABORATORIES LTD

AKNE-MYCIN, ERYTHROMYCIN

ATRALIN, TRETINOIN

CETACORT, HYDROCORTISONE

CLODERM, CLOCORTOLONE PIVALATE

NUTRACORT, HYDROCORTISONE

CORNERSTONE

* CORNERSTONE BIOPHARMA INC

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, ACETAMINOPHEN

SPECTRACEF, CEFDITOREN PIVOXIL

COVENANT PHARMA INC

* CONVENANT PHARMA INC

DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

ETHOSUXIMIDE, ETHOSUXIMIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

CP PHARMS

* CP PHARMACEUTICALS CV

LYRICA, PREGABALIN

CPPI CV

* CP PHARMACEUTICALS INTERNATIONAL CV

SUTENT, SUNITINIB MALATE

CRITICAL

* CRITICAL THERAPEUTICS INC

ZYFLO CR, ZILEUTON

ZYFLO, ZILEUTON

CSL BEHRING

* CSL BEHRING LLC

STIMATE, DESMOPRESSIN ACETATE

CUBIST

* CUBIST PHARMACEUTICALS INC

CUBICIN, DAPTOMYCIN

CUMBERLAND PHARMS

* CUMBERLAND PHARMACEUTICALS INC

ACETADOTE, ACETYLCYSTEINE

CV THERAP

* CV THERAPEUTICS INC

RANEXA, RANOLAZINE

CYPRESS PHARM

* CYPRESS PHARMACEUTICAL INC

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

ELIPHOS, CALCIUM ACETATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

CYTOGEN

* CYTOGEN CORP

QUADRAMET, SAMARIUM SM 153 LEXIDRONAM PENTASODIUM

DABUR ONCOLOGY PLC

* DABUR ONCOLOGY PLC

CARBOPLATIN, CARBOPLATIN

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

PACLITAXEL, PACLITAXEL

DAIICHI

* DAIICHI PHARMACEUTICAL CORP

FLOXIN OTIC, OFLOXACIN

DAIICHI SANKYO

* DAIICHI SANKYO INC

AZOR, AMLODIPINE BESYLATE

BENICAR HCT, HYDROCHLOROTHIAZIDE

BENICAR, OLMESARTAN MEDOXOMIL

WELCHOL, COLESEVELAM HYDROCHLORIDE

DAIICHI SANKYO CO

* DAIICHI SANKYO CO LTD

EVOXAC, CEVIMELINE HYDROCHLORIDE

DAINIPPON

* DAINIPPON PHARMACEUTICAL USA CORP

ZONEGRAN, ZONISAMIDE

DANBURY PHARMA

* WATSON LABORATORIES INC

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **

DANCO LABS LLC

* DANCO LABORATORIES LLC

MIFEPREX, MIFEPRISTONE

DAVA INTL INC

* DAVA INTERNATIONAL INC

ALPRAZOLAM, ALPRAZOLAM

DAVA PHARMS INC

* DAVA PHARMACEUTICALS INC

AMOXICILLIN, AMOXICILLIN

FUROSEMIDE, FUROSEMIDE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

PROPYLTHIOURACIL, PROPYLTHIOURACIL

VOSPIRE ER, ALBUTEROL SULFATE

DAVIS AND GECK

* DAVIS AND GECK DIV AMERICAN CYANAMID CO

PRE-OP II, HEXACHLOROPHENE

PRE-OP, HEXACHLOROPHENE

DEL RAY LABS

* DEL RAY LABORATORIES INC

ALA-CORT, HYDROCORTISONE

ALA-SCALP, HYDROCORTISONE

TRIDERM, TRIAMCINOLONE ACETONIDE

DELL LABS

* DELL LABORATORIES INC

LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE, EPINEPHRINE

DENTSPLY PHARM

* DENTSPLY PHARMACEUTICAL

CITANEST FORTE, EPINEPHRINE BITARTRATE

CITANEST PLAIN, PRILOCAINE HYDROCHLORIDE

ORAQIX, LIDOCAINE

POLOCAINE W/ LEVONORDEFRIN, LEVONORDEFRIN

POLOCAINE, MEPIVACAINE HYDROCHLORIDE

XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE

XYLOCAINE, LIDOCAINE HYDROCHLORIDE

DEPOMED INC

* DEPOMED INC

GLUMETZA, METFORMIN HYDROCHLORIDE

PROQUIN XR, CIPROFLOXACIN HYDROCHLORIDE

DEPROCO

* DEPROCO INC

LIGNOSPAN FORTE, EPINEPHRINE BITARTRATE

LIGNOSPAN STANDARD, EPINEPHRINE BITARTRATE

SCANDONEST L, LEVONORDEFRIN

SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE

SEPTOCAINE, ARTICAINE HYDROCHLORIDE

DEXCEL LTD

* DEXCEL LTD

DICLOFENAC SODIUM, DICLOFENAC SODIUM

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

DEXCEL PHARMA

* DEXCEL PHARMA TECHNOLOGIES LTD

OMEPRAZOLE, OMEPRAZOLE (OTC)

PERIOCHIP, CHLORHEXIDINE GLUCONATE

DEY

* DEY LP

ACCUNEB, ALBUTEROL SULFATE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

CROMOLYN SODIUM, CROMOLYN SODIUM

CUROSURF, PORACTANT ALFA

DUONEB, ALBUTEROL SULFATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **

* DEY LP

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

METAPROTERENOL SULFATE, METAPROTERENOL SULFATE

DEY LP

* DEY LP

PERFOROMIST, FORMOTEROL FUMARATE

DHL

* DHL LABORATORIES INC

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DIALYSIS SUPS

* DIALYSIS SUPPLIES INC

NORMOCARB HF 25, MAGNESIUM CHLORIDE

NORMOCARB HF 35, MAGNESIUM CHLORIDE

DIATOS

* DIATOS SA

DAUNOXOME, DAUNORUBICIN CITRATE

DORC

* DORC INTERNATIONAL BV

VISIONBLUE, TRYPAN BLUE

DOW PHARM SCI

* DOW PHARMACEUTICAL SCIENCES

ACANYA, BENZOYL PEROXIDE

DPT

* DPT LABORATORIES INC

EMBELINE, CLOBETASOL PROPIONATE

DR REDDYS LA

* DR REDDYS LABORATORIES LOUISIANA LLC

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

LOPURIN, ALLOPURINOL

SSD AF, SILVER SULFADIAZINE

SSD, SILVER SULFADIAZINE

DR REDDYS LABS INC

* DR REDDYS LABORATORIES INC

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

FINASTERIDE, FINASTERIDE

FLUCONAZOLE, FLUCONAZOLE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

MELOXICAM, MELOXICAM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

SIMVASTATIN, SIMVASTATIN

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

DR REDDYS LABS LTD

* DR REDDYS LABORATORIES LTD

ALENDRONATE SODIUM, ALENDRONATE SODIUM

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CARVEDILOL, CARVEDILOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 43

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **

* DR REDDYS LABORATORIES LTD

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FINASTERIDE, FINASTERIDE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GLIMEPIRIDE, GLIMEPIRIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

NABUMETONE, NABUMETONE

NAPROXEN SODIUM, NAPROXEN SODIUM

NIZATIDINE, NIZATIDINE

OFLOXACIN, OFLOXACIN

OMEPRAZOLE, OMEPRAZOLE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXAPROZIN, OXAPROZIN

PRIMIDONE, PRIMIDONE

RAMIPRIL, RAMIPRIL

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RANITIDINE, RANITIDINE HYDROCHLORIDE (OTC)

RISPERIDONE, RISPERIDONE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

TRANDOLAPRIL, TRANDOLAPRIL

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

DRAXIMAGE

* DRAXIMAGE INC

DRAXIMAGE MDP-10, TECHNETIUM TC-99M MEDRONATE KIT

DRAXIMAGE MDP-25, TECHNETIUM TC-99M MEDRONATE KIT

DTPA, TECHNETIUM TC-99M PENTETATE KIT

HICON, SODIUM IODIDE, I-131

TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

DURAMED

* DURAMED PHARMACEUTICALS INC

CENESTIN, ESTROGENS, CONJUGATED SYNTHETIC A

ENJUVIA, ESTROGENS, CONJUGATED SYNTHETIC B

LOSEASONIQUE, ETHINYL ESTRADIOL

MIRCETTE, DESOGESTREL

NORDETTE-28, ETHINYL ESTRADIOL

PLAN B, LEVONORGESTREL

PLAN B, LEVONORGESTREL (OTC)

PREFEST, ESTRADIOL

REVIA, NALTREXONE HYDROCHLORIDE

SEASONALE, ETHINYL ESTRADIOL

SYNTHETIC CONJUGATED ESTROGENS A, ESTROGENS, CONJUGATED SYNTHETIC A

DURAMED PHARMS BARR

* DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

AVIANE-28, ETHINYL ESTRADIOL

AYGESTIN, NORETHINDRONE ACETATE

CRYSELLE, ETHINYL ESTRADIOL

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

DIAMOX, ACETAZOLAMIDE

DIAMOX, ACETAZOLAMIDE SODIUM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 44

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **

* DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC

ENPRESSE-28, ETHINYL ESTRADIOL

METHYLPREDNISOLONE, METHYLPREDNISOLONE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

PARAGARD T 380A, COPPER

PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VELIVET, DESOGESTREL

ZEBETA, BISOPROLOL FUMARATE

ZIAC, BISOPROLOL FUMARATE

DURAMED RES

* DURAMED RESEARCH INC

ADDERALL 10, AMPHETAMINE ASPARTATE

ADDERALL 12.5, AMPHETAMINE ASPARTATE

ADDERALL 15, AMPHETAMINE ASPARTATE

ADDERALL 20, AMPHETAMINE ASPARTATE

ADDERALL 30, AMPHETAMINE ASPARTATE

ADDERALL 5, AMPHETAMINE ASPARTATE

ADDERALL 7.5, AMPHETAMINE ASPARTATE

SEASONIQUE, ETHINYL ESTRADIOL

DUSA

* DUSA PHARMACEUTICALS INC

LEVULAN, AMINOLEVULINIC ACID HYDROCHLORIDE

E5 PHARMA INC

* E5 PHARMA INC

ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN

EASTMAN KODAK

* EASTMAN KODAK CO

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE

EBEWE PARENTA

* EBEWE PARENTA PHARMACEUTICALS INC

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

EBEWE PHARMA

* EBEWE PHARMA GES MBH NFG KG

CARBOPLATIN, CARBOPLATIN

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FLUOROURACIL, FLUOROURACIL

PACLITAXEL, PACLITAXEL

VINORELBINE TARTRATE, VINORELBINE TARTRATE

ECOLAB

* ECOLAB INC

CHG SCRUB, CHLORHEXIDINE GLUCONATE (OTC)

CIDA-STAT, CHLORHEXIDINE GLUCONATE (OTC)

ECR

* ECR PHARMACEUTICALS

DEXAMETHASONE, DEXAMETHASONE

EGIS

* EGIS PHARMACEUTICALS

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

PIROXICAM, PIROXICAM

EGIS PHARMS

* EGIS PHARMACEUTICALS LTD

CAPTOPRIL, CAPTOPRIL

EISAI MEDCL RES

* EISAI MEDICAL RESEARCH INC

ACIPHEX, RABEPRAZOLE SODIUM

ARICEPT ODT, DONEPEZIL HYDROCHLORIDE

ARICEPT, DONEPEZIL HYDROCHLORIDE

BANZEL, RUFINAMIDE

FRAGMIN, DALTEPARIN SODIUM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **

* EISAI MEDICAL RESEARCH INC

GLIADEL, CARMUSTINE

HEXALEN, ALTRETAMINE

LUSEDRA, FOSPROPOFOL DISODIUM

PANRETIN, ALITRETINOIN

SALAGEN, PILOCARPINE HYDROCHLORIDE

TARGRETIN, BEXAROTENE

EKR THERAP

* EKR THERAPEUTICS INC

CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDENE SR, NICARDIPINE HYDROCHLORIDE

CARDENE, NICARDIPINE HYDROCHLORIDE

ELAN DRUG

* ELAN DRUG DELIVERY INC

VERELAN PM, VERAPAMIL HYDROCHLORIDE

VERELAN, VERAPAMIL HYDROCHLORIDE

ELAN PHARM

* ELAN PHARMACEUTICAL RESEARCH CORP

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

KETOPROFEN, KETOPROFEN

ELAN PHARMS

* ELAN PHARMACEUTICALS INC

PRIALT, ZICONOTIDE

ELKINS SINN

* ELKINS SINN DIV AH ROBINS CO INC

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

PANCURONIUM, PANCURONIUM BROMIDE

EMD SERONO

* EMD SERONO INC

CETROTIDE, CETRORELIX

GONAL-F RFF PEN, FOLLITROPIN ALFA/BETA

GONAL-F RFF, FOLLITROPIN ALFA/BETA

GONAL-F, FOLLITROPIN ALFA/BETA

LUVERIS, LUTROPIN ALFA

NOVANTRONE, MITOXANTRONE HYDROCHLORIDE

OVIDREL, CHORIOGONADOTROPIN ALFA

SAIZEN, SOMATROPIN RECOMBINANT

SEROPHENE, CLOMIPHENE CITRATE

SEROSTIM, SOMATROPIN RECOMBINANT

ZORBTIVE, SOMATROPIN RECOMBINANT

ENDO PHARMS

* ENDO PHARMACEUTICALS INC

FROVA, FROVATRIPTAN SUCCINATE

HYCODAN, HOMATROPINE METHYLBROMIDE

MOBAN, MOLINDONE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

OPANA ER, OXYMORPHONE HYDROCHLORIDE

OPANA, OXYMORPHONE HYDROCHLORIDE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

PERCOCET, ACETAMINOPHEN

PERCODAN, ASPIRIN

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

SYMMETREL, AMANTADINE HYDROCHLORIDE

ZYDONE, ACETAMINOPHEN

ENTURIA INC

* ENTURIA INC

CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE (OTC)

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 46

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **

* ENTURIA INC

CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE (OTC)

ENZON

* ENZON INC

ABELCET, AMPHOTERICIN B

ENZON PHARMS

* ENZON PHARMACEUTICALS INC

ADAGEN, PEGADEMASE BOVINE

EPIX

* EPIX PHARMACEUTICALS INC

VASOVIST, GADOFOSVESET TRISODIUM

EURAND

* EURAND AMERICA INC

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

EXCELLIUM

* EXCELLIUM PHARMACEUTICAL INC

FOLIC ACID, FOLIC ACID

FUROSEMIDE, FUROSEMIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LORAZEPAM, LORAZEPAM

EYETECH INC

* EYETECH INC

MACUGEN, PEGAPTANIB SODIUM

FALCON PHARMS

* FALCON PHARMACEUTICALS INC

TIMOLOL MALEATE, TIMOLOL MALEATE

* FALCON PHARMACEUTICALS LTD

DIPIVEFRIN HYDROCHLORIDE, DIPIVEFRIN HYDROCHLORIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE

MAXITROL, DEXAMETHASONE

METIPRANOLOL, METIPRANOLOL HYDROCHLORIDE

TIMOLOL MALEATE, TIMOLOL MALEATE

TOBREX, TOBRAMYCIN

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

FDC LTD

* FDC LTD

CIPROFLOXACIN, CIPROFLOXACIN

TIMOLOL MALEATE, TIMOLOL MALEATE

FEINSTEIN

* FEINSTEIN INSTITUTE MEDICAL RESEARCH

AMMONIA N 13, AMMONIA, N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

FERNDALE LABS

* FERNDALE LABORATORIES INC

HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE

MICORT-HC, HYDROCORTISONE ACETATE

PRAMOSONE, HYDROCORTISONE ACETATE

FERRING

* FERRING PHARMACEUTICALS INC

ACTHREL, CORTICORELIN OVINE TRIFLUTATE

BRAVELLE, UROFOLLITROPIN

CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC

DEGARELIX ACETATE, DEGARELIX ACETATE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

ENDOMETRIN, PROGESTERONE

MENOPUR, LUTEINIZING HORMONE

MINIRIN, DESMOPRESSIN ACETATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **

* FERRING PHARMACEUTICALS INC

REPRONEX, LUTEINIZING HORMONE

TEV-TROPIN, SOMATROPIN RECOMBINANT

FLEMING

* FLEMING AND CO

CALOMIST, CYANOCOBALAMIN

* FLEMING AND CO PHARMACEUTICALS

THYROSHIELD, POTASSIUM IODIDE (OTC)

FONTUS PHARMS

* FONTUS PHARMACEUTICALS INC

ROCALTROL, CALCITRIOL

FOREST LABS

* FOREST LABORATORIES INC

AEROSPAN HFA, FLUNISOLIDE

BYSTOLIC, NEBIVOLOL HYDROCHLORIDE

CAMPRAL, ACAMPROSATE CALCIUM

CELEXA, CITALOPRAM HYDROBROMIDE

COMBUNOX, IBUPROFEN

ELIXOPHYLLIN, THEOPHYLLINE

FLUMADINE, RIMANTADINE HYDROCHLORIDE

LEXAPRO, ESCITALOPRAM OXALATE

NAMENDA, MEMANTINE HYDROCHLORIDE

TESSALON, BENZONATATE

THYROLAR-0.25, LIOTHYRONINE SODIUM

THYROLAR-0.5, LIOTHYRONINE SODIUM

THYROLAR-1, LIOTHYRONINE SODIUM

THYROLAR-2, LIOTHYRONINE SODIUM

THYROLAR-3, LIOTHYRONINE SODIUM

FOUGERA

* E FOUGERA DIV ALTANA INC

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

ERYTHROMYCIN, ERYTHROMYCIN

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE, FLUOCINONIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HYDROCORTISONE, HYDROCORTISONE

LIDOCAINE, LIDOCAINE

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE

NITROGLYCERIN, NITROGLYCERIN

NYSTATIN, NYSTATIN

NYSTATIN-TRIAMCINOLONE ACETONIDE, NYSTATIN

FRESENIUS

* FRESENIUS KABI DEUTSCHLAND GMBH

INTRALIPID 10%, SOYBEAN OIL

INTRALIPID 20%, SOYBEAN OIL

INTRALIPID 30%, SOYBEAN OIL

* FRESENIUS USA INC

INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

FRESENIUS MEDCL

* FRESENIUS MEDICAL CARE NORTH AMERICA

CALCITRIOL, CALCITRIOL

DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **

* FRESENIUS MEDICAL CARE NORTH AMERICA

DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM

CHLORIDE

DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PHOSLO GELCAPS, CALCIUM ACETATE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

FSC

* FSC LABORATORIES INC

PRIMSOL, TRIMETHOPRIM HYDROCHLORIDE

G AND W LABS

* G AND W LABORATORIES INC

ACEPHEN, ACETAMINOPHEN (OTC)

CICLOPIROX, CICLOPIROX

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

INDOMETHACIN, INDOMETHACIN

METRONIDAZOLE, METRONIDAZOLE

MICONAZOLE 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)

MIGERGOT, CAFFEINE

MOMETASONE FUROATE, MOMETASONE FUROATE

PROCHLORPERAZINE, PROCHLORPERAZINE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROMETHEGAN, PROMETHAZINE HYDROCHLORIDE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TRUPHYLLINE, AMINOPHYLLINE

GALDERMA LABS

* GALDERMA LABORATORIES INC

CLOBEX, CLOBETASOL PROPIONATE

EPIDUO, ADAPALENE

GALDERMA LABS LP

* GALDERMA LABORATORIES L P

CLOBEX, CLOBETASOL PROPIONATE

* GALDERMA LABORATORIES LP

CLINDAGEL, CLINDAMYCIN PHOSPHATE

CLOBEX, CLOBETASOL PROPIONATE

DESOWEN, DESONIDE

DIFFERIN, ADAPALENE

FS, FLUOCINOLONE ACETONIDE

LIDOCAINE AND TETRACAINE, LIDOCAINE

METROCREAM, METRONIDAZOLE

METROGEL, METRONIDAZOLE

METROLOTION, METRONIDAZOLE

METVIXIA, METHYL AMINOLEVULINATE HYDROCHLORIDE

ORACEA, DOXYCYCLINE

PERIOSTAT, DOXYCYCLINE HYCLATE

TRI-LUMA, FLUOCINOLONE ACETONIDE

GALEN LTD

* GALEN LTD

FEMRING, ESTRADIOL ACETATE

GAMBRO RENAL PRODS

* GAMBRO RENAL PRODUCTS

PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GAMBRO RENAL PRODUCTS

PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

GD SEARLE

* GD SEARLE LLC

CELEBREX, CELECOXIB

DAYPRO, OXAPROZIN

GD SEARLE LLC

* GD SEARLE LLC

ALDACTAZIDE, HYDROCHLOROTHIAZIDE

ALDACTONE, SPIRONOLACTONE

ARTHROTEC, DICLOFENAC SODIUM

CALAN, VERAPAMIL HYDROCHLORIDE

COVERA-HS, VERAPAMIL HYDROCHLORIDE

CYTOTEC, MISOPROSTOL

DEMULEN 1/35-21, ETHINYL ESTRADIOL

DEMULEN 1/35-28, ETHINYL ESTRADIOL

DEMULEN 1/50-21, ETHINYL ESTRADIOL

DEMULEN 1/50-28, ETHINYL ESTRADIOL

FLAGYL ER, METRONIDAZOLE

FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE

FLAGYL I.V., METRONIDAZOLE HYDROCHLORIDE

FLAGYL, METRONIDAZOLE

INSPRA, EPLERENONE

LOMOTIL, ATROPINE SULFATE

NORPACE CR, DISOPYRAMIDE PHOSPHATE

NORPACE, DISOPYRAMIDE PHOSPHATE

SYNAREL, NAFARELIN ACETATE

GE HEALTHCARE

* GE HEALTHCARE

ADREVIEW, IOBENGUANE SULFATE I 123

CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT

HYPAQUE, DIATRIZOATE SODIUM

INDICLOR, INDIUM IN-111 CHLORIDE

INDIUM IN-111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE

METASTRON, STRONTIUM CHLORIDE, SR-89

MPI DMSA KIDNEY REAGENT, TECHNETIUM TC-99M SUCCIMER KIT

MPI DTPA KIT - CHELATE, TECHNETIUM TC-99M PENTETATE KIT

MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM

MYOVIEW, TECHNETIUM TC-99M TETROFOSMIN KIT

OMNIPAQUE 140, IOHEXOL

OMNIPAQUE 180, IOHEXOL

OMNIPAQUE 240, IOHEXOL

OMNIPAQUE 300, IOHEXOL

OMNIPAQUE 350, IOHEXOL

OMNISCAN, GADODIAMIDE

OPTISON, ALBUMIN HUMAN

SODIUM IODIDE I 123, SODIUM IODIDE, I-123

TECHNETIUM TC 99M MPI MDP, TECHNETIUM TC-99M MEDRONATE KIT

TECHNETIUM TC-99M PENTETATE KIT, TECHNETIUM TC-99M PENTETATE KIT

THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE, TL-201

VISIPAQUE 270, IODIXANOL

VISIPAQUE 320, IODIXANOL

GEDEON RICHTER USA

* GEDEON RICHTER USA INC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

FINASTERIDE, FINASTERIDE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 50

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

GENENTECH

* GENENTECH INC

NUTROPIN AQ PEN, SOMATROPIN RECOMBINANT

NUTROPIN AQ, SOMATROPIN RECOMBINANT

NUTROPIN, SOMATROPIN RECOMBINANT

GENERAMEDIX

* GENERAMEDIX INC

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

* GENERAMEDIX PHARMACEUTICALS INC

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

CARBOPLATIN, CARBOPLATIN

FLUOROURACIL, FLUOROURACIL

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

GENIX THERAP

* GENIX THERAPEUTICS INC

CALCITRIOL, CALCITRIOL

GENPHARM

* GENPHARM INC

ACYCLOVIR, ACYCLOVIR

AMNESTEEM, ISOTRETINOIN

AZATHIOPRINE, AZATHIOPRINE

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLARITHROMYCIN, CLARITHROMYCIN

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ETIDRONATE DISODIUM, ETIDRONATE DISODIUM

ETOPOSIDE, ETOPOSIDE

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

FLUCONAZOLE, FLUCONAZOLE

FLUTAMIDE, FLUTAMIDE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

GLIMEPIRIDE, GLIMEPIRIDE

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM

LORATADINE, LORATADINE (OTC)

LOVASTATIN, LOVASTATIN

MELOXICAM, MELOXICAM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHIMAZOLE, METHIMAZOLE

NIZATIDINE, NIZATIDINE

OXAPROZIN, OXAPROZIN

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RANITIDINE, RANITIDINE HYDROCHLORIDE (OTC)

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE

WARFARIN SODIUM, WARFARIN SODIUM

ZALEPLON, ZALEPLON

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* GENPHARM PHARMACEUTICALS INC

ATENOLOL, ATENOLOL

GENPHARM ULC

* GENPHARM ULC

ALENDRONATE SODIUM, ALENDRONATE SODIUM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 51

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GENPHARM ULC

DIVALPROEX SODIUM, DIVALPROEX SODIUM

LAMOTRIGINE, LAMOTRIGINE

GENTA

* GENTA INC

GANITE, GALLIUM NITRATE

GENZYME

* GENZYME CORP

CEREDASE, ALGLUCERASE

CEREZYME, IMIGLUCERASE

CLOLAR, CLOFARABINE

HECTOROL, DOXERCALCIFEROL

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

MOZOBIL, PLERIXAFOR

RENAGEL, SEVELAMER HYDROCHLORIDE

RENVELA, SEVELAMER CARBONATE

THYROGEN, THYROTROPIN ALFA

GILEAD

* GILEAD SCIENCES INC

ATRIPLA, EFAVIRENZ

EMTRIVA, EMTRICITABINE

HEPSERA, ADEFOVIR DIPIVOXIL

LETAIRIS, AMBRISENTAN

TRUVADA, EMTRICITABINE

VIREAD, TENOFOVIR DISOPROXIL FUMARATE

VISTIDE, CIDOFOVIR

GLAND PHARMA LTD

* GLAND PHARMA LTD

ADENOSINE, ADENOSINE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL LACTATE

MILRINONE LACTATE, MILRINONE LACTATE

GLAXO

* GLAXOSMITHKLINE INC

LEXIVA, FOSAMPRENAVIR CALCIUM

GLAXO GRP LTD

* GLAXO GROUP LTD DBA GLAXOSMITHKLINE

ALTABAX, RETAPAMULIN

FLOVENT HFA, FLUTICASONE PROPIONATE

SEREVENT, SALMETEROL XINAFOATE

GLAXOSMITHKLINE

* GLAXOSMITHKLINE

ABREVA, DOCOSANOL (OTC)

ACLOVATE, ALCLOMETASONE DIPROPIONATE

ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE

ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE

ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE

ADVAIR HFA, FLUTICASONE PROPIONATE

AGENERASE, AMPRENAVIR

ALBENZA, ALBENDAZOLE

ALKERAN, MELPHALAN

ALKERAN, MELPHALAN HYDROCHLORIDE

AMERGE, NARATRIPTAN HYDROCHLORIDE

AMOXIL, AMOXICILLIN

ANCEF, CEFAZOLIN SODIUM

ARIXTRA, FONDAPARINUX SODIUM

AUGMENTIN '125', AMOXICILLIN

AUGMENTIN '200', AMOXICILLIN

AUGMENTIN '250', AMOXICILLIN

AUGMENTIN '400', AMOXICILLIN

AUGMENTIN '500', AMOXICILLIN

AUGMENTIN '875', AMOXICILLIN

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 52

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GLAXOSMITHKLINE

AUGMENTIN XR, AMOXICILLIN

AVODART, DUTASTERIDE

BACTOCILL, OXACILLIN SODIUM

BACTROBAN, MUPIROCIN

BACTROBAN, MUPIROCIN CALCIUM

BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFTIN, CEFUROXIME AXETIL

CLOXAPEN, CLOXACILLIN SODIUM

COMBIVIR, LAMIVUDINE

DARAPRIM, PYRIMETHAMINE

DYAZIDE, HYDROCHLOROTHIAZIDE

EPIVIR, LAMIVUDINE

EPIVIR-HBV, LAMIVUDINE

FLOLAN, EPOPROSTENOL SODIUM

FLONASE, FLUTICASONE PROPIONATE

FLOVENT DISKUS 100, FLUTICASONE PROPIONATE

FLOVENT DISKUS 250, FLUTICASONE PROPIONATE

FLOVENT DISKUS 50, FLUTICASONE PROPIONATE

FORTAZ IN PLASTIC CONTAINER, CEFTAZIDIME SODIUM

FORTAZ, CEFTAZIDIME

HYCAMTIN, TOPOTECAN HYDROCHLORIDE

IMITREX STATDOSE, SUMATRIPTAN SUCCINATE

IMITREX, SUMATRIPTAN

IMITREX, SUMATRIPTAN SUCCINATE

LAMICTAL CD, LAMOTRIGINE

LAMICTAL, LAMOTRIGINE

LANOXIN PEDIATRIC, DIGOXIN

LANOXIN, DIGOXIN

LAROTID, AMOXICILLIN

LEXIVA, FOSAMPRENAVIR CALCIUM

MALARONE PEDIATRIC, ATOVAQUONE

MALARONE, ATOVAQUONE

MEPRON, ATOVAQUONE

MYLERAN, BUSULFAN

NICORETTE (MINT), NICOTINE POLACRILEX (OTC)

NICORETTE, NICOTINE POLACRILEX (OTC)

PARNATE, TRANYLCYPROMINE SULFATE

PAXIL CR, PAROXETINE HYDROCHLORIDE

PAXIL, PAROXETINE HYDROCHLORIDE

PROMACTA, ELTROMBOPAG OLAMINE

RELENZA, ZANAMIVIR

REQUIP, ROPINIROLE HYDROCHLORIDE

RETROVIR, ZIDOVUDINE

TAGAMET HB, CIMETIDINE (OTC)

TAGAMET, CIMETIDINE

THIOGUANINE, THIOGUANINE

TIMENTIN IN PLASTIC CONTAINER, CLAVULANATE POTASSIUM

TIMENTIN, CLAVULANATE POTASSIUM

TREXIMET, NAPROXEN SODIUM

TRIZIVIR, ABACAVIR SULFATE

VALTREX, VALACYCLOVIR HYDROCHLORIDE

VENTOLIN HFA, ALBUTEROL SULFATE

VERAMYST, FLUTICASONE FUROATE

WELLBUTRIN SR, BUPROPION HYDROCHLORIDE

WELLBUTRIN, BUPROPION HYDROCHLORIDE

ZANTAC 150, RANITIDINE HYDROCHLORIDE

ZANTAC 25, RANITIDINE HYDROCHLORIDE

ZANTAC 300, RANITIDINE HYDROCHLORIDE

ZANTAC IN PLASTIC CONTAINER, RANITIDINE HYDROCHLORIDE

ZANTAC, RANITIDINE HYDROCHLORIDE

ZIAGEN, ABACAVIR SULFATE

ZINACEF IN PLASTIC CONTAINER, CEFUROXIME SODIUM

ZINACEF, CEFUROXIME SODIUM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 53

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GLAXOSMITHKLINE

ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE

ZOFRAN ODT, ONDANSETRON

ZOFRAN PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ZOFRAN, ONDANSETRON HYDROCHLORIDE

ZOVIRAX, ACYCLOVIR

ZOVIRAX, ACYCLOVIR SODIUM

ZYBAN, BUPROPION HYDROCHLORIDE

GLAXOSMITHKLINE CONS

* GLAXOSMITHKLINE CONSUMER HEALTHCARE

ALLI, ORLISTAT (OTC)

COMMIT, NICOTINE POLACRILEX (OTC)

GLENMARK GENERICS

* GLENMARK GENERICS INC USA

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

DIPYRIDAMOLE, DIPYRIDAMOLE

MOMETASONE FUROATE, MOMETASONE FUROATE

NILSTAT, NYSTATIN

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

ZONISAMIDE, ZONISAMIDE

* GLENMARK GENERICS LTD

CARVEDILOL, CARVEDILOL

FLUCONAZOLE, FLUCONAZOLE

GABAPENTIN, GABAPENTIN

MELOXICAM, MELOXICAM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM

NAPROXEN, NAPROXEN

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

OXCARBAZEPINE, OXCARBAZEPINE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TRANDOLAPRIL, TRANDOLAPRIL

GOLDLINE

* GOLDLINE LABORATORIES INC

CLOZAPINE, CLOZAPINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

GRACEWAY

* GRACEWAY PHARMACEUTICALS LLC

ALDARA, IMIQUIMOD

CALCIUM DISODIUM VERSENATE, EDETATE CALCIUM DISODIUM

ESTRASORB, ESTRADIOL HEMIHYDRATE

MAXAIR, PIRBUTEROL ACETATE

METROGEL-VAGINAL, METRONIDAZOLE

MINITRAN, NITROGLYCERIN

NORFLEX, ORPHENADRINE CITRATE

NORGESIC FORTE, ASPIRIN

NORGESIC, ASPIRIN

TAMBOCOR, FLECAINIDE ACETATE

THEOLAIR, THEOPHYLLINE

GRAHAM CHEM

* GRAHAM CHEMICAL CO

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE, LIDOCAINE

MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRIN, LEVONORDEFRIN

MEPIVACAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE

GRIFFEN

* KW GRIFFEN CO

BIOSCRUB, CHLORHEXIDINE GLUCONATE (OTC)

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 54

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

GTX INC

* GTX INC

FARESTON, TOREMIFENE CITRATE

GUARDIAN DRUG

* GUARDIAN DRUG CO INC

FOAMCOAT, ALUMINUM HYDROXIDE (OTC)

GUERBET

* GUERBET LLC

HEXABRIX, IOXAGLATE MEGLUMINE

OXILAN-300, IOXILAN

OXILAN-350, IOXILAN

HAEMONETICS

* HAEMONETICS CORP

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

HALOCARBON PRODS

* HALOCARBON PRODUCTS CORP

ISOFLURANE, ISOFLURANE

SEVOFLURANE, SEVOFLURANE

HALOZYME THERAP

* HALOZYME THERAPEUTICS INC

HYLENEX RECOMBINANT, HYALURONIDASE RECOMBINANT HUMAN

HAMELN PHARMS

* HAMELN PHARMACEUTICALS GMBH

PENTETATE CALCIUM TRISODIUM, PENTETATE CALCIUM TRISODIUM

PENTETATE ZINC TRISODIUM, PENTETATE ZINC TRISODIUM

HAMPTON LAINE LLC

* HAMPTON LAINE LLC

FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE

HANFORD GC

* GC HANFORD MANUFACTURING CO

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFTRIAXONE, CEFTRIAXONE SODIUM

CEFUROXIME SODIUM, CEFUROXIME SODIUM

HARMONY LABS

* HARMONY LABORATORIES

THEROXIDIL, MINOXIDIL (OTC)

HARRIS PHARM

* HARRIS PHARMACEUTICAL INC

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

HEALTHPOINT

* HEALTHPOINT LTD

CORMAX, CLOBETASOL PROPIONATE

EMBELINE E, CLOBETASOL PROPIONATE

EMBELINE, CLOBETASOL PROPIONATE

HELSINN HLTHCARE

* HELSINN HEALTHCARE SA

ALOXI, PALONOSETRON HYDROCHLORIDE

HEMOPHARM USA

* HEMOPHARM USA CORP

A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE

HERCON LABS

* HERCON LABORATORIES CORP

NITROGLYCERIN, NITROGLYCERIN

HERITAGE PHARMS INC

* HERITAGE PHARMACEUTICALS INC

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 55

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HERITAGE PHARMACEUTICALS INC

KETOPROFEN, KETOPROFEN

HETERO DRUGS

* HETERO DRUGS LTD

STAVUDINE, STAVUDINE

HETERO DRUGS LTD

* HETERO DRUGS LTD UNIT III

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

ZIDOVUDINE, ZIDOVUDINE

HEYL CHEMISCH

* HEYL CHEMISCH PHARMAZEUTISHE FABRIK

RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II)

HI TECH PHARMA

* HI TECH PHARMACAL CO INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACYCLOVIR, ACYCLOVIR

ALBUTEROL SULFATE, ALBUTEROL SULFATE

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

CICLOPIROX, CICLOPIROX

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

ERYTHRO-STATIN, ERYTHROMYCIN

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

LACTULOSE, LACTULOSE

LEVOCARNITINE, LEVOCARNITINE

LIDOCAINE AND PRILOCAINE, LIDOCAINE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)

OFLOXACIN, OFLOXACIN

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PREDNISOLONE, PREDNISOLONE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN

HYDROBROMIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

TIMOLOL MALEATE, TIMOLOL MALEATE

VOSOL HC, ACETIC ACID, GLACIAL

HIGH TECH PHARMA

* HIGH TECHNOLOGY PHARMACAL CO INC

VALPROIC ACID, VALPROIC ACID

HIKMA

* HIKMA FARMACEUTICA LDA

CEFOTAXIME, CEFOTAXIME SODIUM

* HIKMA PHARMACEUTICALS

AMOXICILLIN, AMOXICILLIN

CARVEDILOL, CARVEDILOL

CEFACLOR, CEFACLOR

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEPHALEXIN, CEPHALEXIN

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

GABAPENTIN, GABAPENTIN

GLYBURIDE (MICRONIZED), GLYBURIDE

NAPROXEN SODIUM, NAPROXEN SODIUM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 56

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HIKMA PHARMACEUTICALS

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

HIKMA FARMACEUTICA

* HIKMA FARMACEUTICA (PORTUGAL) SA

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

CEFTRIAXONE, CEFTRIAXONE SODIUM

ENALAPRILAT, ENALAPRILAT

METOPROLOL TARTRATE, METOPROLOL TARTRATE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PHENYTOIN SODIUM, PHENYTOIN SODIUM

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

* HIKMA FARMACEUTICA PORTUGAL LDA

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFUROXIME SODIUM, CEFUROXIME SODIUM

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

HIKMA PHARMS

* HIKMA PHARMACEUTICALS

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

HILL DERMAC

* HILL DERMACEUTICALS INC

DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

HISAMITSU

* HISAMITSU PHARMACEUTICAL CO INC

SALONPAS, MENTHOL (OTC)

HITECH PHARMA

* HITECH PHARMACAL CORP

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

HLR

* HLR TECHNOLOGY

ACCUTANE, ISOTRETINOIN

INVIRASE, SAQUINAVIR MESYLATE

ROCEPHIN, CEFTRIAXONE SODIUM

ROMAZICON, FLUMAZENIL

XELODA, CAPECITABINE

XENICAL, ORLISTAT

HOLOPACK INTL

* HOLOPACK INTERNATIONAL CORP

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

HOSPIRA

* HOSPIRA INC

ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM

ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL

ACETYLCYSTEINE, ACETYLCYSTEINE

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM

A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE

ALCOHOL 5% IN D5-W, ALCOHOL

ALFENTANIL, ALFENTANIL HYDROCHLORIDE

A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE

AMIDATE, ETOMIDATE

AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, AMIKACIN SULFATE

AMIKACIN SULFATE, AMIKACIN SULFATE

AMINOCAPROIC ACID IN PLASTIC CONTAINER, AMINOCAPROIC ACID

AMINOCAPROIC ACID, AMINOCAPROIC ACID

AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%, AMINOPHYLLINE

AMINOPHYLLINE, AMINOPHYLLINE

AMINOSYN 10% (PH6), AMINO ACIDS

AMINOSYN 10%, AMINO ACIDS

AMINOSYN 3.5% M, AMINO ACIDS

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 57

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HOSPIRA INC

AMINOSYN 3.5%, AMINO ACIDS

AMINOSYN 5%, AMINO ACIDS

AMINOSYN 7% (PH6), AMINO ACIDS

AMINOSYN 7% W/ ELECTROLYTES, AMINO ACIDS

AMINOSYN 7%, AMINO ACIDS

AMINOSYN 8.5% (PH6), AMINO ACIDS

AMINOSYN 8.5% W/ ELECTROLYTES, AMINO ACIDS

AMINOSYN 8.5%, AMINO ACIDS

AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN II 10% W/ ELECTROLYTES, AMINO ACIDS

AMINOSYN II 10%, AMINO ACIDS

AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO

ACIDS

AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER, AMINO

ACIDS

AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, AMINO

ACIDS

AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN II 7%, AMINO ACIDS

AMINOSYN II 8.5% W/ ELECTROLYTES, AMINO ACIDS

AMINOSYN II 8.5%, AMINO ACIDS

AMINOSYN-HBC 7%, AMINO ACIDS

AMINOSYN-HF 8%, AMINO ACIDS

AMINOSYN-PF 10%, AMINO ACIDS

AMINOSYN-PF 7%, AMINO ACIDS

AMINOSYN-RF 5.2%, AMINO ACIDS

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMMONIUM CHLORIDE IN PLASTIC CONTAINER, AMMONIUM CHLORIDE

AMRINONE, INAMRINONE LACTATE

AQUASOL A, VITAMIN A PALMITATE

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

ATROPINE SULFATE ANSYR PLASTIC SYRINGE, ATROPINE SULFATE

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, WATER FOR INJECTION, STERILE

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER, BRETYLIUM TOSYLATE

BRETYLIUM TOSYLATE, BRETYLIUM TOSYLATE

BUMETANIDE, BUMETANIDE

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE, BUPIVACAINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE

CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

CARBOCAINE, MEPIVACAINE HYDROCHLORIDE

CARBOPLATIN, CARBOPLATIN

CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE

CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE

CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, CIMETIDINE

HYDROCHLORIDE

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CIPROFLOXACIN, CIPROFLOXACIN

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 58

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HOSPIRA INC

CORLOPAM, FENOLDOPAM MESYLATE

CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE

CYTARABINE, CYTARABINE

DACARBAZINE, DACARBAZINE

DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE

DEMEROL, MEPERIDINE HYDROCHLORIDE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 25%, DEXTROSE

DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 60% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE

DIAZEPAM, DIAZEPAM

DIGOXIN, DIGOXIN

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%, DOBUTAMINE HYDROCHLORIDE

DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE

DROPERIDOL, DROPERIDOL

EDROPHONIUM CHLORIDE, EDROPHONIUM CHLORIDE

ENALAPRILAT, ENALAPRILAT

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

ERYC, ERYTHROMYCIN

ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE

ETOPOSIDE, ETOPOSIDE

FAMOTIDINE, FAMOTIDINE

FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE

FENTANYL CITRATE, FENTANYL CITRATE

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FOSCARNET SODIUM, FOSCARNET SODIUM

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

FUROSEMIDE, FUROSEMIDE

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE

HEPARIN LOCK FLUSH IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN LOCK FLUSH, HEPARIN SODIUM

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 59

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HOSPIRA INC

IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

IONOSOL T AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

IOPAMIDOL-200 IN PLASTIC CONTAINER, IOPAMIDOL

IOPAMIDOL-200, IOPAMIDOL

IOPAMIDOL-250 IN PLASTIC CONTAINER, IOPAMIDOL

IOPAMIDOL-250, IOPAMIDOL

IOPAMIDOL-300 IN PLASTIC CONTAINER, IOPAMIDOL

IOPAMIDOL-300, IOPAMIDOL

IOPAMIDOL-370 IN PLASTIC CONTAINER, IOPAMIDOL

IOPAMIDOL-370, IOPAMIDOL

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

ISOFLURANE, ISOFLURANE

ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE

ISUPREL, ISOPROTERENOL HYDROCHLORIDE

KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

LEVOPHED, NOREPINEPHRINE BITARTRATE

LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LIPOSYN II 10%, SAFFLOWER OIL

LIPOSYN II 20%, SAFFLOWER OIL

LIPOSYN III 10%, SOYBEAN OIL

LIPOSYN III 20%, SOYBEAN OIL

LIPOSYN III 30%, SOYBEAN OIL

LORAZEPAM, LORAZEPAM

LTA II KIT, LIDOCAINE HYDROCHLORIDE

M.V.I. ADULT (PHARMACY BULK PACKAGE), ASCORBIC ACID

M.V.I. ADULT, ASCORBIC ACID

M.V.I. PEDIATRIC, ASCORBIC ACID

M.V.I.-12 (WITHOUT VITAMIN K), ASCORBIC ACID

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE

MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 25%, MANNITOL

MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL

MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

MARCAINE, BUPIVACAINE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE

MILRINONE LACTATE, MILRINONE LACTATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 60

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HOSPIRA INC

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN

NITROGLYCERIN, NITROGLYCERIN

NITROPRESS, SODIUM NITROPRUSSIDE

NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

NOVAMINE 11.4%, AMINO ACIDS

NOVAMINE 15%, AMINO ACIDS

NOVOCAIN, PROCAINE HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PACLITAXEL, PACLITAXEL

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PANCURONIUM BROMIDE, PANCURONIUM BROMIDE

PEDIATRIC LTA KIT, LIDOCAINE HYDROCHLORIDE

PHENYTOIN SODIUM, PHENYTOIN SODIUM

PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PHYSIOSOL PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE

POTASSIUM ACETATE IN PLASTIC CONTAINER, POTASSIUM ACETATE

POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM

CHLORIDE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

CALCIUM CHLORIDE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 61

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **
* HOSPIRA INC
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

CALCIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

DEXTROSE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PRECEDEX, DEXMEDETOMIDINE

PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROPOFOL, PROPOFOL

QUELICIN PRESERVATIVE FREE, SUCCINYLCHOLINE CHLORIDE

QUELICIN, SUCCINYLCHOLINE CHLORIDE

RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

RITODRINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, RITODRINE HYDROCHLORIDE

RITODRINE HYDROCHLORIDE, RITODRINE HYDROCHLORIDE

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

SODIUM ACETATE IN PLASTIC CONTAINER, SODIUM ACETATE, ANHYDROUS

SODIUM BICARBONATE, SODIUM BICARBONATE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM LACTATE IN PLASTIC CONTAINER, SODIUM LACTATE

SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, WATER FOR INJECTION, STERILE

STERILE WATER IN PLASTIC CONTAINER, WATER FOR IRRIGATION, STERILE

SUFENTANIL CITRATE, SUFENTANIL CITRATE

TALWIN, PENTAZOCINE LACTATE

TAZICEF, CEFTAZIDIME

THAM, TROMETHAMINE

THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, TOBRAMYCIN SULFATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

VITAMIN K1, PHYTONADIONE

ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE

HOSPIRA INC

* HOSPIRA INC

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

MEPIVACAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 62

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HOSPIRA INC

NIPENT, PENTOSTATIN

IBI

* ISTITUTO BIOCHIMICO ITALIANO SPA

AMPICILLIN SODIUM, AMPICILLIN SODIUM

IMPAX LABS

* IMPAX LABORATORIES INC

ALPRAZOLAM, ALPRAZOLAM

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

BACLOFEN, BACLOFEN

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE

DANTROLENE SODIUM, DANTROLENE SODIUM

DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FENOFIBRATE, FENOFIBRATE

FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE

LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)

LORATADINE, LORATADINE (OTC)

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHOCARBAMOL, METHOCARBAMOL

METHYLTESTOSTERONE, METHYLTESTOSTERONE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

NADOLOL AND BENDROFLUMETHIAZIDE, BENDROFLUMETHIAZIDE

OMEPRAZOLE, OMEPRAZOLE

PENTOXIFYLLINE, PENTOXIFYLLINE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

PRIMIDONE, PRIMIDONE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

RILUZOLE, RILUZOLE

RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE

TERBUTALINE SULFATE, TERBUTALINE SULFATE

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE

IMPAX PHARMS

* IMPAX PHARMACEUTICALS

FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE

GEMFIBROZIL, GEMFIBROZIL

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

INALCO

* INALCO SPA

LACTULOSE, LACTULOSE

INDEVUS

* INDEVUS PHARMACEUTICALS INC

SANCTURA XR, TROSPIUM CHLORIDE

SANCTURA, TROSPIUM CHLORIDE

SUPPRELIN LA, HISTRELIN ACETATE

VANTAS, HISTRELIN ACETATE

INDEVUS PHARMS

* INDEVUS PHARMACEUTICALS

DELATESTRYL, TESTOSTERONE ENANTHATE

VALSTAR PRESERVATIVE FREE, VALRUBICIN

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **

INDICUS PHARMA

* INDICUS PHARMA LLC

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

INO

* INO THERAPEUTICS INC

INOMAX, NITRIC OXIDE

INSIGHT PHARMS

* INSIGHT PHARMACEUTICALS CORP

NIX, PERMETHRIN (OTC)

INSPIRE

* INSPIRE PHARMACEUTICALS INC

AZASITE, AZITHROMYCIN

INST BIOCHEM

* INSTITUT BIOCHEMIQUE SA

FLECTOR, DICLOFENAC EPOLAMINE

INSTITUTO BIOCHEMICO

* INSTITUTO BIOCHEMICO ITALIANO SPA

AMPICILLIN SODIUM, AMPICILLIN SODIUM

INSTITUTO BIOCHIMICO

* INSTITUTO BIOCHIMICO ITALIANO SPA

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

INTENDIS

* INTENDIS INC

FINACEA, AZELAIC ACID

INTL MEDICATED

* INTERNATIONAL MEDICATED SYSTEMS LTD

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE, MILRINONE LACTATE

INTL MEDICATION

* INTERNATIONAL MEDICATION SYSTEM

AMINOPHYLLINE, AMINOPHYLLINE

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE

FUROSEMIDE, FUROSEMIDE

ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE

LARYNG-O-JET KIT, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

MANNITOL 25%, MANNITOL

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

PHYTONADIONE, PHYTONADIONE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

* INTERNATIONAL MEDICATION SYSTEMS LTD

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

FUROSEMIDE, FUROSEMIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

INTL MEDICATION SYS

* INTERNATIONAL MEDICATION SYSTEMS LTD

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

LORAZEPAM, LORAZEPAM

INVAGEN PHARMS

* INVAGEN PHARMACEUTICALS INC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

GEMFIBROZIL, GEMFIBROZIL

GLIMEPIRIDE, GLIMEPIRIDE

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **

* INVAGEN PHARMACEUTICALS INC

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

MEPROBAMATE, MEPROBAMATE

NABUMETONE, NABUMETONE

QUINAPRIL, QUINAPRIL HYDROCHLORIDE

RAMIPRIL, RAMIPRIL

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TRANDOLAPRIL, TRANDOLAPRIL

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

INVERNESS MEDCL

* INVERNESS MEDICAL NUTRITIONALS GROUP

NIFEDIPINE, NIFEDIPINE

INWOOD LABS

* INWOOD LABORATORIES INC SUB FOREST LABORATORIES INC

CARBAMAZEPINE, CARBAMAZEPINE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

THEOCHRON, THEOPHYLLINE

THEOPHYLLINE, THEOPHYLLINE

IPCA LABS LTD

* IPCA LABORATORIES LTD

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

IPR

* IPR PHARMACEUTICALS INC

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

ATENOLOL, ATENOLOL

CRESTOR, ROSUVASTATIN CALCIUM

ZOMIG, ZOLMITRIPTAN

IPSEN LTD

* IPSEN LTD

APOKYN, APOMORPHINE HYDROCHLORIDE

ISO TEX

* ISO TEX DIAGNOSTICS INC

JEANATOPE, ALBUMIN IODINATED I-125 SERUM

MEGATOPE, ALBUMIN IODINATED I-131 SERUM

ISTA PHARMS

* ISTA PHARMACEUTICALS

ISTALOL, TIMOLOL MALEATE

VITRASE, HYALURONIDASE

XIBROM, BROMFENAC SODIUM

ISTITUTO BIOCHIMICO

* ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI

PIPERACILLIN, PIPERACILLIN SODIUM

IV THERAP

* IV THERAPEUTICS LLC

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

IVAX PHARMS

* IVAX PHARMACEUTICALS INC

ACYCLOVIR, ACYCLOVIR

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

BACLOFEN, BACLOFEN

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **

* IVAX PHARMACEUTICALS INC

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

BUMETANIDE, BUMETANIDE

CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEPHALEXIN, CEPHALEXIN

CILOSTAZOL, CILOSTAZOL

CIMETIDINE, CIMETIDINE

CIMETIDINE, CIMETIDINE (OTC)

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLARITHROMYCIN, CLARITHROMYCIN

CLOZAPINE, CLOZAPINE

CROMOLYN SODIUM, CROMOLYN SODIUM

CYCLOSPORINE, CYCLOSPORINE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DIAZEPAM, DIAZEPAM

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

FENOPROFEN CALCIUM, FENOPROFEN CALCIUM

FLUCONAZOLE, FLUCONAZOLE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUTAMIDE, FLUTAMIDE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

FUROSEMIDE, FUROSEMIDE

GABAPENTIN, GABAPENTIN

GLIPIZIDE, GLIPIZIDE

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GUANABENZ ACETATE, GUANABENZ ACETATE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

INDAPAMIDE, INDAPAMIDE

INDOMETHACIN, INDOMETHACIN

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LORAZEPAM, LORAZEPAM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHOCARBAMOL AND ASPIRIN, ASPIRIN

METHYLDOPA, METHYLDOPA

METRONIDAZOLE, METRONIDAZOLE

MISOPROSTOL, MISOPROSTOL

NADOLOL, NADOLOL

NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

OXAPROZIN, OXAPROZIN

OXAZEPAM, OXAZEPAM

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

PREDNISOLONE, PREDNISOLONE

PROBENECID AND COLCHICINE, COLCHICINE

PROBENECID, PROBENECID

PROMPT PHENYTOIN SODIUM, PHENYTOIN SODIUM

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, ACETAMINOPHEN

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RANITIDINE, RANITIDINE HYDROCHLORIDE (OTC)

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

SULFISOXAZOLE, SULFISOXAZOLE

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE

TOLAZAMIDE, TOLAZAMIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **

* IVAX PHARMACEUTICALS INC

TOLMETIN SODIUM, TOLMETIN SODIUM

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

* IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS

DOXYCYCLINE, DOXYCYCLINE

IVAX PHARMS INC

* IVAX PHARMACEUTICALS INC

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

BUDESONIDE, BUDESONIDE

CABERGOLINE, CABERGOLINE

GRISEOFULVIN, GRISEOFULVIN

J AND J

* JOHNSON AND JOHNSON MEDICAL INC

MICRODERM, CHLORHEXIDINE GLUCONATE (OTC)

PREVACARE R, CHLORHEXIDINE GLUCONATE (OTC)

JACOBUS

* JACOBUS PHARMACEUTICAL CO

DAPSONE, DAPSONE

PASER, AMINOSALICYLIC ACID

JAZZ

* JAZZ PHARMACEUTICALS

LUVOX CR, FLUVOXAMINE MALEATE

LUVOX, FLUVOXAMINE MALEATE

XYREM, SODIUM OXYBATE

JHP PHARMS

* JHP PHARMACEUTICALS LLC

BREVITAL SODIUM, METHOHEXITAL SODIUM

COLY-MYCIN M, COLISTIMETHATE SODIUM

COLY-MYCIN S, COLISTIN SULFATE

DANTRIUM, DANTROLENE SODIUM

DELESTROGEN, ESTRADIOL VALERATE

KETALAR, KETAMINE HYDROCHLORIDE

PITOCIN, OXYTOCIN

TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE

TRIOSTAT, LIOTHYRONINE SODIUM

JOHN O BUTLER CO

* JOHN O BUTLER CO

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

JOHNSON AND JOHNSON

* JOHNSON AND JOHNSON CONSUMER COMPANIES INC

RENOVA, TRETINOIN

RETIN-A MICRO, TRETINOIN

RETIN-A, TRETINOIN

* JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES

MEN'S ROGAINE, MINOXIDIL (OTC)

ROGAINE (FOR MEN), MINOXIDIL (OTC)

ROGAINE (FOR WOMEN), MINOXIDIL (OTC)

ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE (OTC)

VISINE-A, NAPHAZOLINE HYDROCHLORIDE (OTC)

* JOHNSON AND JOHNSON HEALTHCARE PRODUCTS

MONISTAT 1 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MONISTAT 3 COMBINATION PACK (PREFILLED), MICONAZOLE NITRATE (OTC)

MONISTAT 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MONISTAT 3, MICONAZOLE NITRATE (OTC)

MONISTAT 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MONISTAT 7, MICONAZOLE NITRATE (OTC)

MONISTAT-3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

* JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT LLC

DORIBAX, DORIPENEM

VIADUR, LEUPROLIDE ACETATE

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** K **

KALI LABS

* KALI LABORATORIES INC

ALPRAZOLAM, ALPRAZOLAM

CAPTOPRIL, CAPTOPRIL

CLONAZEPAM, CLONAZEPAM

GLIPIZIDE, GLIPIZIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

LEFLUNOMIDE, LEFLUNOMIDE

METRONIDAZOLE, METRONIDAZOLE

NYSTATIN, NYSTATIN

ONDANSETRON, ONDANSETRON

OXANDROLONE, OXANDROLONE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

* KALI LABS

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

KALI LABS INC

* KALI LABORATORIES INC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

KENDALL LP

* KENDALL CO LP

THERMAZENE, SILVER SULFADIAZINE

KENWOOD LABS

* KENWOOD LABORATORIES DIV BRADLEY PHARMACEUTICALS

CARMOL HC, HYDROCORTISONE ACETATE

TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE

KEY PHARMS

* KEY PHARMACEUTICALS INC SUB SCHERING PLOUGH CORP

NITRO-DUR, NITROGLYCERIN

KIEL

* KIEL LABORATORIES INC

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

KING PHARMS

* KING PHARMACEUTICALS INC

ALTACE, RAMIPRIL

AVINZA, MORPHINE SULFATE

BICILLIN C-R 900/300, PENICILLIN G BENZATHINE

BICILLIN C-R, PENICILLIN G BENZATHINE

BICILLIN L-A, PENICILLIN G BENZATHINE

CORGARD, NADOLOL

CORZIDE, BENDROFLUMETHIAZIDE

CYTOMEL, LIOTHYRONINE SODIUM

INTAL, CROMOLYN SODIUM

LEVOXYL, LEVOTHYROXINE SODIUM

PENICILLIN G PROCAINE, PENICILLIN G PROCAINE

SILVADENE, SILVER SULFADIAZINE

SKELAXIN, METAXALONE

SYNERCID, DALFOPRISTIN

TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE

* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC SUB KING PHARMACEUTICALS INC

SONATA, ZALEPLON

TAPAZOLE, METHIMAZOLE

TUSSIGON, HOMATROPINE METHYLBROMIDE

KREMERS URBAN

* KREMERS URBAN CO

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

NITROGLYCERIN, NITROGLYCERIN

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** K **

KREMERS URBAN DEV

* KREMERS URBAN DEVELOPMENT CO

OMEPRAZOLE, OMEPRAZOLE

KRKA DD NOVO MESTO

* KRKA DD NOVO MESTO

ENALAPRIL MALEATE, ENALAPRIL MALEATE

KV PHARM

* KV PHARMACEUTICAL CO

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BENZONATATE, BENZONATATE

BROMPHENIRAMINE MALEATE, BROMPHENIRAMINE MALEATE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CLINDESSE, CLINDAMYCIN PHOSPHATE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

EVAMIST, ESTRADIOL

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

GYNAZOLE-1, BUTOCONAZOLE NITRATE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

MICRO-K 10, POTASSIUM CHLORIDE

MICRO-K, POTASSIUM CHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NYSTATIN, NYSTATIN

ONDANSETRON, ONDANSETRON

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PREDNISOLONE, PREDNISOLONE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

KVK TECH

* KVK TECH INC

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

LABOPHARM CANADA INC

* LABOPHARM CANADA INC

RYZOLT, TRAMADOL HYDROCHLORIDE

LABS ATRAL

* LABORATORIOS ATRAL SARL

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE

LANNETT

* LANNETT CO INC

ACETAZOLAMIDE, ACETAZOLAMIDE

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

LANORINAL, ASPIRIN

METHOCARBAMOL, METHOCARBAMOL

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PRIMIDONE, PRIMIDONE

PROBALAN, PROBENECID

SERPALAN, RESERPINE

* LANNETT HOLDINGS INC

ALBUTEROL SULFATE, ALBUTEROL SULFATE

BACLOFEN, BACLOFEN

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

* LANNETT HOLDINGS INC

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

DANAZOL, DANAZOL

DIPYRIDAMOLE, DIPYRIDAMOLE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

RIFAMPIN, RIFAMPIN

TERBUTALINE SULFATE, TERBUTALINE SULFATE

URSODIOL, URSODIOL

LANTHEUS MEDCL

* LANTHEUS MEDICAL IMAGING INC

CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT

DEFINITY, PERFLUTREN

GALLIUM CITRATE GA 67, GALLIUM CITRATE, GA-67

NEUROLITE, TECHNETIUM TC-99M BICISATE KIT

TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE, TL-201

XENON XE 133, XENON, XE-133

LAVIPHARM LABS

* LAVIPHARM LABORATORIES INC

FENTANYL-100, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-75, FENTANYL

LEINER

* LEINER HEALTH PRODUCTS INC

CIMETIDINE, CIMETIDINE (OTC)

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

PREDNISONE, PREDNISONE

PROFEN, IBUPROFEN (OTC)

RANITIDINE, RANITIDINE HYDROCHLORIDE (OTC)

LEK PHARMS

* LEK PHARMACEUTICALS D D

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE

CIMETIDINE, CIMETIDINE

CIMETIDINE, CIMETIDINE (OTC)

ENALAPRIL MALEATE, ENALAPRIL MALEATE

LISINOPRIL, LISINOPRIL

OMEPRAZOLE, OMEPRAZOLE

LEK PHARMS DD

* LEK PHARMACEUTICALS DD

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

LEO PHARM

* LEO PHARMACEUTICAL PRODUCTS LTD

DOVONEX, CALCIPOTRIENE

LEO PHARM PRODS

* LEO PHARMACEUTICAL PRODUCTS LTD

TACLONEX SCALP, BETAMETHASONE DIPROPIONATE

TACLONEX, BETAMETHASONE DIPROPIONATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

LEX PHARMS

* LEX PHARMACEUTICALS INC

KEFLEX, CEPHALEXIN

LG LIFE

* LG LIFE SCIENCES LTD

VALTROPIN, SOMATROPIN RECOMBINANT

LILLY

* ELI LILLY AND CO

ALIMTA, PEMETREXED DISODIUM

CAPASTAT SULFATE, CAPREOMYCIN SULFATE

CIALIS, TADALAFIL

CYMBALTA, DULOXETINE HYDROCHLORIDE

EVISTA, RALOXIFENE HYDROCHLORIDE

FORTEO, TERIPARATIDE RECOMBINANT HUMAN

GEMZAR, GEMCITABINE HYDROCHLORIDE

GLUCAGON, GLUCAGON RECOMBINANT

HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT

HUMALOG MIX 50/50 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG MIX 50/50, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG MIX 75/25 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG MIX 75/25, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG PEN, INSULIN LISPRO RECOMBINANT

HUMALOG, INSULIN LISPRO RECOMBINANT

HUMATROPE, SOMATROPIN RECOMBINANT

HUMULIN 50/50, INSULIN RECOMBINANT HUMAN (OTC)

HUMULIN 70/30 PEN, INSULIN RECOMBINANT HUMAN (OTC)

HUMULIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)

HUMULIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)

HUMULIN R PEN, INSULIN RECOMBINANT HUMAN (OTC)

HUMULIN R, INSULIN RECOMBINANT HUMAN

HUMULIN R, INSULIN RECOMBINANT HUMAN (OTC)

PROZAC WEEKLY, FLUOXETINE HYDROCHLORIDE

PROZAC, FLUOXETINE HYDROCHLORIDE

QUINIDINE GLUCONATE, QUINIDINE GLUCONATE

STRATTERA, ATOMOXETINE HYDROCHLORIDE

SYMBYAX, FLUOXETINE HYDROCHLORIDE

ZYPREXA ZYDIS, OLANZAPINE

ZYPREXA, OLANZAPINE

* LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO

PROZAC, FLUOXETINE HYDROCHLORIDE

SARAFEM, FLUOXETINE HYDROCHLORIDE

LLOYD

* LLOYD INC

LEVOTHROID, LEVOTHYROXINE SODIUM

LNK

* LNK INTERNATIONAL INC

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC)

IBUPROFEN, IBUPROFEN (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

LOREAL USA

* LOREAL USA PRODUCTS INC

ANTHELIOS 20, AVOBENZONE (OTC)

ANTHELIOS 40, AVOBENZONE (OTC)

ANTHELIOS SX, AVOBENZONE (OTC)

CAPITAL SOLEIL 15, AVOBENZONE (OTC)

LUITPOLD

* LUITPOLD PHARMACEUTICALS INC

ACETYLCYSTEINE, ACETYLCYSTEINE

AMINOCAPROIC ACID, AMINOCAPROIC ACID

AMINOPHYLLINE, AMINOPHYLLINE

BRETYLIUM TOSYLATE, BRETYLIUM TOSYLATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

* LUITPOLD PHARMACEUTICALS INC

CAFFEINE CITRATE, CAFFEINE CITRATE

CALCITRIOL, CALCITRIOL

CEFTRIAXONE, CEFTRIAXONE SODIUM

CYANOCOBALAMIN, CYANOCOBALAMIN

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXFERRUM, IRON DEXTRAN

DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE

DROPERIDOL, DROPERIDOL

FUROSEMIDE, FUROSEMIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM

LEVOCARNITINE, LEVOCARNITINE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

MANNITOL 25%, MANNITOL

METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE

NITROGLYCERIN, NITROGLYCERIN

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

VENOFER, IRON SUCROSE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

LUPIN

* LUPIN LTD

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CARVEDILOL, CARVEDILOL

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFDINIR, CEFDINIR

CEFOTAXIME SODIUM, CEFOTAXIME SODIUM

CEFPROZIL, CEFPROZIL

CEFTRIAXONE, CEFTRIAXONE SODIUM

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEPHALEXIN, CEPHALEXIN

DIVALPROEX SODIUM, DIVALPROEX SODIUM

LEVETIRACETAM, LEVETIRACETAM

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LOVASTATIN, LOVASTATIN

QUINAPRIL, QUINAPRIL HYDROCHLORIDE

RAMIPRIL, RAMIPRIL

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

SUPRAX, CEFIXIME

TRANDOLAPRIL, TRANDOLAPRIL

LUPIN PHARMS

* LUPIN PHARMACEUTICALS INC

MELOXICAM, MELOXICAM

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

SUPRAX, CEFIXIME

LYNE

* LYNE LABORATORIES INC

CALCITRIOL, CALCITRIOL

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

LEVOCARNITINE, LEVOCARNITINE

MALLINCKRODT

* MALLINCKRODT CHEMICAL INC

ANEXSIA 7.5/650, ACETAMINOPHEN

ANEXSIA, ACETAMINOPHEN

BONTRIL, PHENDIMETRAZINE TARTRATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MALLINCKRODT CHEMICAL INC

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

LORCET-HD, ACETAMINOPHEN

LORTAB, ACETAMINOPHEN

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHADOSE, METHADONE HYDROCHLORIDE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

* MALLINCKRODT INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ANEXSIA 5/325, ACETAMINOPHEN

ANEXSIA 7.5/325, ACETAMINOPHEN

ANEXSIA, ACETAMINOPHEN

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

ASPARTATE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHYLIN ER, METHYLPHENIDATE HYDROCHLORIDE

METHYLIN, METHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

OPTIMARK IN PLASTIC CONTAINER, GADOVERSETAMIDE

OPTIMARK, GADOVERSETAMIDE

OXYCET, ACETAMINOPHEN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, ACETAMINOPHEN

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

TECHNETIUM TC-99 SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE, TL-201

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

* MALLINCKRODT MEDICAL INC

CONRAY 30, IOTHALAMATE MEGLUMINE

CONRAY 43, IOTHALAMATE MEGLUMINE

CONRAY, IOTHALAMATE MEGLUMINE

CYSTO-CONRAY II, IOTHALAMATE MEGLUMINE

GALLIUM CITRATE GA 67, GALLIUM CITRATE, GA-67

INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE

MD-76R, DIATRIZOATE MEGLUMINE

MD-GASTROVIEW, DIATRIZOATE MEGLUMINE

OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT

OPTIRAY 160, IOVERSOL

OPTIRAY 240, IOVERSOL

OPTIRAY 300, IOVERSOL

OPTIRAY 320, IOVERSOL

OPTIRAY 350, IOVERSOL

PHOSPHOCOL P32, CHROMIC PHOSPHATE, P-32

SODIUM CHROMATE CR 51, SODIUM CHROMATE, CR-51

SODIUM IODIDE I 123, SODIUM IODIDE, I-123

SODIUM IODIDE I 131, SODIUM IODIDE, I-131

SODIUM PHOSPHATE P 32, SODIUM PHOSPHATE, P-32

TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT

TECHNESCAN PYP KIT, TECHNETIUM TC-99M PYROPHOSPHATE KIT

TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT

THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE, TL-201

ULTRATAG, TECHNETIUM TC-99M RED BLOOD CELL KIT

ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

XENON XE 133, XENON, XE-133

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

MARSAM PHARMS LLC

* MARSAM PHARMACEUTICALS LLC

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

CEFACLOR, CEFACLOR

CEFUROXIME SODIUM, CEFUROXIME SODIUM

DIAZEPAM, DIAZEPAM

ETOPOSIDE, ETOPOSIDE

ISOFLURANE, ISOFLURANE

OXACILLIN SODIUM, OXACILLIN SODIUM

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

MARSHALL PHARMA

* MARSHALL PHARMACAL CORP

SODIUM BUTABARBITAL, BUTABARBITAL SODIUM

MARTEC USA LLC

* MARTEC USA LLC

NIFEDIPINE, NIFEDIPINE

MATRIX LABS INC

* MATRIX LABORATORIES INC

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

STAVUDINE, STAVUDINE

MATRIX LABS LTD

* MATRIX LABORATORIES LTD

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

STAVUDINE, STAVUDINE

ZIDOVUDINE, ZIDOVUDINE

MAYNE PHARMA INTL

* MAYNE PHARMA INTERNATIONAL FAULDING PHARM

DORYX, DOXYCYCLINE HYCLATE

MCNEIL

* MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC

CHILDREN'S MOTRIN, IBUPROFEN (OTC)

IBUPROFEN, IBUPROFEN (OTC)

IMODIUM A-D EZ CHEWS, LOPERAMIDE HYDROCHLORIDE (OTC)

IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC)

MEDIPREN, IBUPROFEN (OTC)

MOTRIN IB, IBUPROFEN (OTC)

MOTRIN MIGRAINE PAIN, IBUPROFEN (OTC)

ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE (OTC)

MCNEIL CONS

* MCNEIL CONSUMER HEALTHCARE

BENADRYL PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE

BENADRYL, DIPHENHYDRAMINE HYDROCHLORIDE

CHILDREN'S MOTRIN COLD, IBUPROFEN (OTC)

CHILDREN'S MOTRIN, IBUPROFEN (OTC)

IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE (OTC)

IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC)

IMODIUM, LOPERAMIDE HYDROCHLORIDE

JUNIOR STRENGTH MOTRIN, IBUPROFEN (OTC)

NIZORAL A-D, KETOCONAZOLE (OTC)

SINE-AID IB, IBUPROFEN (OTC)

SUDAFED 12 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)

TYLENOL (CAPLET), ACETAMINOPHEN (OTC)

TYLENOL (GELTAB), ACETAMINOPHEN (OTC)

MCNEIL CONSUMER

* MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC

CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

MOTRIN, IBUPROFEN

ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC

ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

ZYRTEC, CETIRIZINE HYDROCHLORIDE

MCNEIL PED

* MCNEIL PEDIATRICS

FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE

MEAD JOHNSON

* MEAD JOHNSON AND CO

CAFCIT, CAFFEINE CITRATE

MEDA PHARMS

* MEDA PHARMACEUTICALS INC

ASTELIN, AZELASTINE HYDROCHLORIDE

BUTISOL SODIUM, BUTABARBITAL SODIUM

DEMADEX, TORSEMIDE

DEPEN, PENICILLAMINE

FELBATOL, FELBAMATE

LUFYLLIN, DYPHYLLINE

OPTIVAR, AZELASTINE HYDROCHLORIDE

* MEDA PHARMACEUTICALS MEDA PHARMACEUTICALS INC

ASTEPRO, AZELASTINE HYDROCHLORIDE

SOMA COMPOUND W/ CODEINE, ASPIRIN

SOMA COMPOUND, ASPIRIN

SOMA, CARISOPRODOL

MEDICINES CO

* THE MEDICINES CO

ANGIOMAX, BIVALIRUDIN

MEDICIS

* MEDICIS PHARMACEUTICAL CORP

BUPHENYL, SODIUM PHENYLBUTYRATE

DYNACIN, MINOCYCLINE HYDROCHLORIDE

LIDEX, FLUOCINONIDE

LIDEX-E, FLUOCINONIDE

LOPROX, CICLOPIROX

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE

SOLODYN, MINOCYCLINE HYDROCHLORIDE

SYNACORT, HYDROCORTISONE

SYNALAR, FLUOCINOLONE ACETONIDE

VANOS, FLUOCINONIDE

ZIANA, CLINDAMYCIN PHOSPHATE

MEDICURE

* MEDICURE INTERNATIONAL INC

AGGRASTAT, TIROFIBAN HYDROCHLORIDE

MEDIGENE

* MEDIGENE INC

VEREGEN, SINECATECHINS

MEDIMMUNE

* MEDIMMUNE

ETHYOL, AMIFOSTINE

MEDS CO

* THE MEDICINES CO

CLEVIPREX, CLEVIDIPINE BUTYRATE

MEDTRONIC

* MEDTRONIC INC

LIORESAL, BACLOFEN

MERCK

* MERCK AND CO INC

AMINOHIPPURATE SODIUM, AMINOHIPPURATE SODIUM

CANCIDAS, CASPOFUNGIN ACETATE

EMEND, APREPITANT

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MERCK AND CO INC

FOSAMAX PLUS D, ALENDRONATE SODIUM

FOSAMAX, ALENDRONATE SODIUM

HYZAAR, HYDROCHLOROTHIAZIDE

INVANZ, ERTAPENEM SODIUM

JANUMET, METFORMIN HYDROCHLORIDE

MAXALT, RIZATRIPTAN BENZOATE

MAXALT-MLT, RIZATRIPTAN BENZOATE

MINTEZOL, THIABENDAZOLE

PRIMAXIN, CILASTATIN SODIUM

PROSCAR, FINASTERIDE

SINGULAIR, MONTELUKAST SODIUM

STROMECTOL, IVERMECTIN

ZOLINZA, VORINOSTAT

* MERCK RESEARCH LABORATORIES DIV MERCK CO INC

CLINORIL, SULINDAC

COSOPT, DORZOLAMIDE HYDROCHLORIDE

COZAAR, LOSARTAN POTASSIUM

CRIXIVAN, INDINAVIR SULFATE

INDOCIN, INDOMETHACIN

MEVACOR, LOVASTATIN

NOROXIN, NORFLOXACIN

PEPCID AC (GELTAB), FAMOTIDINE (OTC)

PEPCID AC, FAMOTIDINE (OTC)

PEPCID COMPLETE, CALCIUM CARBONATE (OTC)

PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE

PEPCID PRESERVATIVE FREE, FAMOTIDINE

PEPCID, FAMOTIDINE

PRINIVIL, LISINOPRIL

PRINZIDE, HYDROCHLOROTHIAZIDE

PROPECIA, FINASTERIDE

SINGULAIR, MONTELUKAST SODIUM

TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE

TIMOPTIC, TIMOLOL MALEATE

TIMOPTIC-XE, TIMOLOL MALEATE

TRUSOPT, DORZOLAMIDE HYDROCHLORIDE

ZOCOR, SIMVASTATIN

MERCK AND CO INC

* MERCK AND CO INC

EMEND, FOSAPREPITANT DIMEGLUMINE

FOSAMAX, ALENDRONATE SODIUM

ISENTRESS, RALTEGRAVIR POTASSIUM

MERCK CO INC

* MERCK CO INC

JANUVIA, SITAGLIPTIN PHOSPHATE

MERCK SANTE SAS

* MERCK SANTE SAS

CYANOKIT, HYDROXOCOBALAMIN

MERIDIAN MEDCL

* MERIDIAN MEDICAL TECHNOLOGIES INC

DUODOTE, ATROPINE

MERIDIAN MEDCL TECHN

* MERIDIAN MEDICAL TECHNOLOGIES INC

ATROPEN, ATROPINE

EPIPEN JR., EPINEPHRINE

EPIPEN, EPINEPHRINE

LIDOPEN, LIDOCAINE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

PRALIDOXIME CHLORIDE, PRALIDOXIME CHLORIDE

MERZ PHARMS

* MERZ PHARMACEUTICALS LLC

ERYGEL, ERYTHROMYCIN

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MERZ PHARMACEUTICALS LLC

NAFTIN, NAFTIFINE HYDROCHLORIDE

METHAPHARM

* METHAPHARM INC

PROVOCHOLINE, METHACHOLINE CHLORIDE

METRICS PHARM

* METRICS PHARMACEUTICAL VENTURES LLC

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

MGI PHARMA INC

* MGI PHARMA INC

DACOGEN, DECITABINE

MICROBIX BIOSYSTEMS

* MICROBIX BIOSYSTEMS INC

KINLYTIC, UROKINASE

MIDDLEBROOK PHARMS

* MIDDLEBROOK PHARMACEUTICALS INC

MOXATAG, AMOXICILLIN

MIKART

* MIKART INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMINOCAPROIC ACID, AMINOCAPROIC ACID

AMINOCAPROIC, AMINOCAPROIC ACID

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

BUTAPAP, ACETAMINOPHEN

CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE

ESGIC-PLUS, ACETAMINOPHEN

ETHOSUXIMIDE, ETHOSUXIMIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

ISONIAZID, ISONIAZID

METHAZOLAMIDE, METHAZOLAMIDE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

PYRAZINAMIDE, PYRAZINAMIDE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

MILEX

* MILEX PRODUCTS INC

MILOPHENE, CLOMIPHENE CITRATE

MILLENNIUM PHARMS

* MILLENNIUM PHARMACEUTICALS INC

VELCADE, BORTEZOMIB

MINRAD

* MINRAD INC

ENFLURANE, ENFLURANE

ISOFLURANE, ISOFLURANE

SOJOURN, SEVOFLURANE

MISSION PHARMA

* MISSION PHARMACAL CO

FOLICET, FOLIC ACID

LITHOSTAT, ACETOHYDROXAMIC ACID

TINDAMAX, TINIDAZOLE

TIOPRONIN, TIOPRONIN

UROCIT-K, POTASSIUM CITRATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

MIZA PHARMS USA

* MIZA PHARMACEUTICALS USA INC

OCUSULF-10, SULFACETAMIDE SODIUM

TROPICAMIDE, TROPICAMIDE

MONARCH PHARMS

* MONARCH PHARMACEUTICALS INC

CORTISPORIN, BACITRACIN ZINC

CORTISPORIN, HYDROCORTISONE

CORTISPORIN, HYDROCORTISONE ACETATE

MENEST, ESTROGENS, ESTERIFIED

NEOSPORIN G.U. IRRIGANT, NEOMYCIN SULFATE

NEOSPORIN, GRAMICIDIN

PEDIOTIC, HYDROCORTISONE

SEPTRA DS, SULFAMETHOXAZOLE

SEPTRA, SULFAMETHOXAZOLE

THALITONE, CHLORTHALIDONE

VIROPTIC, TRIFLURIDINE

MORTON GROVE

* MORTON GROVE ACQUISITION CORP

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

* MORTON GROVE PHARMACEUTICALS INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACETIC ACID, ACETIC ACID, GLACIAL

ALBUTEROL SULFATE, ALBUTEROL SULFATE

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMOXICILLIN, AMOXICILLIN

CARBAMAZEPINE, CARBAMAZEPINE

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CROMOLYN SODIUM, CROMOLYN SODIUM

CYCLOSPORINE, CYCLOSPORINE

DEXAMETHASONE, DEXAMETHASONE

DEXCHLORPHENIRAMINE MALEATE, DEXCHLORPHENIRAMINE MALEATE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

ERYTHROMYCIN, ERYTHROMYCIN

FUROSEMIDE, FUROSEMIDE

GENERLAC, LACTULOSE

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

LACTULOSE, LACTULOSE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LINDANE, LINDANE

LITHIUM CITRATE, LITHIUM CITRATE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

LORATADINE, LORATADINE (OTC)

MEGESTROL ACETATE, MEGESTROL ACETATE

METAPROTERENOL SULFATE, METAPROTERENOL SULFATE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

MYPHETANE DX, BROMPHENIRAMINE MALEATE

NYSTATIN, NYSTATIN

PHENTYTOIN, PHENYTOIN

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PREDNISOLONE, PREDNISOLONE

PROMETHAZINE PLAIN, PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE W/ CODEINE, CODEINE PHOSPHATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MORTON GROVE PHARMACEUTICALS INC

PROMETHAZINE W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE

SELENIUM SULFIDE, SELENIUM SULFIDE

THEOPHYLLINE, THEOPHYLLINE

TRETINOIN, TRETINOIN

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VALPROIC ACID, VALPROIC ACID

MORTON GROVE PHARMS

* MORTON GROVE PHARMACEUTICALS

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

MSP SINGAPORE

* MSP SINGAPORE CO LLC

VYTORIN, EZETIMIBE

ZETIA, EZETIMIBE

MURTY PHARMS

* MURTY PHARMACEUTICALS INC

DIPYRIDAMOLE, DIPYRIDAMOLE

MUTUAL PHARM

* MUTUAL PHARMACEUTICAL CO INC

ACETAZOLAMIDE, ACETAZOLAMIDE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALLOPURINOL, ALLOPURINOL

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

ATENOLOL, ATENOLOL

BACTRIM DS, SULFAMETHOXAZOLE

BACTRIM, SULFAMETHOXAZOLE

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

CARISOPRODOL, CARISOPRODOL

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

ERGOLOID MESYLATES, ERGOLOID MESYLATES

FELODIPINE, FELODIPINE

FOLIC ACID, FOLIC ACID

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

LORAZEPAM, LORAZEPAM

LOVASTATIN, LOVASTATIN

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METRONIDAZOLE, METRONIDAZOLE

MINOXIDIL, MINOXIDIL

NYSTATIN, NYSTATIN

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PIROXICAM, PIROXICAM

PREDNISONE, PREDNISONE

PRIMIDONE, PRIMIDONE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

QUINIDINE GLUCONATE, QUINIDINE GLUCONATE

QUINIDINE SULFATE, QUINIDINE SULFATE

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

SPIRONOLACTONE, SPIRONOLACTONE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SULINDAC, SULINDAC

THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE

TOLMETIN SODIUM, TOLMETIN SODIUM

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

ZONISAMIDE, ZONISAMIDE

MUTUAL PHARMA

* MUTUAL PHARMACAL CO

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 79

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MUTUAL PHARMACAL CO

KETOCONAZOLE, KETOCONAZOLE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

MYLAN

* MYLAN LABORATORIES INC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

CAPTOPRIL, CAPTOPRIL

ETODOLAC, ETODOLAC

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

* MYLAN PHARMACEUTICALS INC

ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

ALLOPURINOL, ALLOPURINOL

ALPRAZOLAM, ALPRAZOLAM

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

ATENOLOL, ATENOLOL

AZITHROMYCIN, AZITHROMYCIN

BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL

CARBIDOPA AND LEVODOPA, CARBIDOPA

CARVEDILOL, CARVEDILOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

CHLOROTHIAZIDE, CHLOROTHIAZIDE

CHLORPROPAMIDE, CHLORPROPAMIDE

CHLORTHALIDONE, CHLORTHALIDONE

CILOSTAZOL, CILOSTAZOL

CIMETIDINE, CIMETIDINE

CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM

CLORPRES, CHLORTHALIDONE

CLOZAPINE, CLOZAPINE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

CYSTAGON, CYSTEAMINE BITARTRATE

DIAZEPAM, DIAZEPAM

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN PHARMACEUTICALS INC

ESTRADIOL, ESTRADIOL

ESTROPIPATE, ESTROPIPATE

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

FAMOTIDINE, FAMOTIDINE

FELODIPINE, FELODIPINE

FENOPROFEN CALCIUM, FENOPROFEN CALCIUM

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FINASTERIDE, FINASTERIDE

FLUCONAZOLE, FLUCONAZOLE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE

FLURBIPROFEN, FLURBIPROFEN

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

FUROSEMIDE, FUROSEMIDE

GLIMEPIRIDE, GLIMEPIRIDE

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GLIPIZIDE, GLIPIZIDE

GLYBURIDE (MICRONIZED), GLYBURIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

INDAPAMIDE, INDAPAMIDE

INDOMETHACIN, INDOMETHACIN

KETOCONAZOLE, KETOCONAZOLE

KETOPROFEN, KETOPROFEN

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LETROZOLE, LETROZOLE

LEVETIRACETAM, LEVETIRACETAM

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

LORATADINE, LORATADINE (OTC)

LORAZEPAM, LORAZEPAM

LOVASTATIN, LOVASTATIN

LOXAPINE, LOXAPINE SUCCINATE

MAPROTILINE HYDROCHLORIDE, MAPROTILINE HYDROCHLORIDE

MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM

MELOXICAM, MELOXICAM

MERCAPTOPURINE, MERCAPTOPURINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METHYCLOTHIAZIDE, METHYCLOTHIAZIDE

METHYLDOPA AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

METHYLDOPA, METHYLDOPA

METOLAZONE, METOLAZONE

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

NADOLOL AND BENDROFLUMETHAZIDE, BENDROFLUMETHIAZIDE

NADOLOL, NADOLOL

NAPROXEN, NAPROXEN

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

NIZATIDINE, NIZATIDINE

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

OMEPRAZOLE, OMEPRAZOLE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 81

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN PHARMACEUTICALS INC

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PACLITAXEL, PACLITAXEL

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PENTOXIFYLLINE, PENTOXIFYLLINE

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

PHENYTEK, PHENYTOIN SODIUM

PINDOLOL, PINDOLOL

PIROXICAM, PIROXICAM

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

PROBENECID, PROBENECID

PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

PROPOXYPHENE HYDROCHLORIDE, PROPOXYPHENE HYDROCHLORIDE

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, ACETAMINOPHEN

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

SPIRONOLACTONE, SPIRONOLACTONE

SULINDAC, SULINDAC

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TEMAZEPAM, TEMAZEPAM

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE

THIOTHIXENE, THIOTHIXENE

TIMOLOL MALEATE, TIMOLOL MALEATE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOLAZAMIDE, TOLAZAMIDE

TOLBUTAMIDE, TOLBUTAMIDE

TOLMETIN SODIUM, TOLMETIN SODIUM

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRANDOLAPRIL, TRANDOLAPRIL

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

* MYLAN PHARMACEUTICALS INC.

NISOLDIPINE, NISOLDIPINE

MYLAN BERTEK

* MYLAN BERTEK PHARMACEUTICALS INC

AVITA, TRETINOIN

MAXZIDE, HYDROCHLOROTHIAZIDE

MAXZIDE-25, HYDROCHLOROTHIAZIDE

MENTAX, BUTENAFINE HYDROCHLORIDE

MENTAX-TC, BUTENAFINE HYDROCHLORIDE

MYLAN TECHNOLOGIES

* MYLAN TECHNOLOGIES INC

ESTRADIOL, ESTRADIOL

FENTANYL-100, FENTANYL

FENTANYL-12, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-75, FENTANYL

* MYLAN TECHNOLOGIES, INC.

NITROGLYCERIN, NITROGLYCERIN

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 82

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

NATCO PHARMA LTD

* NATCO PHARMA LTD

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

NAVINTA LLC

* NAVINTA LLC

FOMEPIZOLE, FOMEPIZOLE

NBTY ACQUISITION

* NBTY ACQUISITION LLC

FOLIC ACID, FOLIC ACID

NEPHRON

* NEPHRON CORP

ALBUTEROL SULFATE, ALBUTEROL SULFATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

* NEPHRON PHARMACEUTICALS CORP

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

METAPROTERENOL SULFATE, METAPROTERENOL SULFATE

NEUROSCI INC

* NEUROSCI INC

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NEW RIVER

* NEW RIVER PHARMACEUTICALS INC

PROFERDEX, IRON DEXTRAN

NEW RIVER PHARMS

* NEW RIVER PHARMACEUTICALS INC

VYVANSE, LISDEXAMFETAMINE DIMESYLATE

NEXGEN PHARMA INC

* NEXGEN PHARMA INC

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

NEXUS PHARMS

* NEXUS PHARMACEUTICALS INC

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

NITROMED

* NITROMED INC

BIDIL, HYDRALAZINE HYDROCHLORIDE

NORTHSTAR HLTHCARE

* NORTHSTAR HEALTHCARE HOLDINGS LTD

ALLOPURINOL, ALLOPURINOL

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

IBUPROFEN, IBUPROFEN

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

NOSTRUM

* NOSTRUM PHARMACEUTICALS INC

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

NOSTRUM LABS

* NOSTRUM LABORATORIES INC

DICLOFENAC SODIUM, DICLOFENAC SODIUM

PIROXICAM, PIROXICAM

NOVADEL

* NOVADEL PHARMA INC

NITROMIST, NITROGLYCERIN

ZOLPIMIST, ZOLPIDEM TARTRATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 83

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

NOVALAR

* NOVALAR PHARMACEUTICALS INC

ORAVERSE, PHENTOLAMINE MESYLATE

NOVARTIS

* NOVARTIS CONSUMER HEALTH INC

DENAVIR, PENCICLOVIR SODIUM

EXCEDRIN (MIGRAINE), ACETAMINOPHEN (OTC)

HABITROL, NICOTINE (OTC)

LAMISIL AT, TERBINAFINE (OTC)

LAMISIL AT, TERBINAFINE HYDROCHLORIDE (OTC)

LAMISIL, TERBINAFINE

LAMISIL, TERBINAFINE HYDROCHLORIDE

LAMISIL, TERBINAFINE HYDROCHLORIDE (OTC)

TAVIST ALLERGY/SINUS/HEADACHE, ACETAMINOPHEN (OTC)

THRIVE, NICOTINE POLACRILEX (OTC)

TRANSDERM SCOP, SCOPOLAMINE

VAGISTAT-1, TIOCONAZOLE (OTC)

VOLTAREN, DICLOFENAC SODIUM

* NOVARTIS PHARMACEUTICALS CORP

AREDIA, PAMIDRONATE DISODIUM

CATAFLAM, DICLOFENAC POTASSIUM

CLOZARIL, CLOZAPINE

COMBIPATCH, ESTRADIOL

DESFERAL, DEFEROXAMINE MESYLATE

DIOVAN HCT, HYDROCHLOROTHIAZIDE

DIOVAN, VALSARTAN

ELIDEL, PIMECROLIMUS

ENABLEX, DARIFENACIN HYDROBROMIDE

ESTRADERM, ESTRADIOL

EXELON, RIVASTIGMINE

EXELON, RIVASTIGMINE TARTRATE

EXFORGE, AMLODIPINE BESYLATE

EXJADE, DEFERASIROX

FAMVIR, FAMCICLOVIR

FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE

FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE

FORADIL CERTIHALER, FORMOTEROL FUMARATE

FORADIL, FORMOTEROL FUMARATE

GLEEVEC, IMATINIB MESYLATE

HYDERGINE, ERGOLOID MESYLATES

LAMISIL, TERBINAFINE HYDROCHLORIDE

LAMPRENE, CLOFAZIMINE

LESCOL XL, FLUVASTATIN SODIUM

LESCOL, FLUVASTATIN SODIUM

LOPRESSOR HCT, HYDROCHLOROTHIAZIDE

LOPRESSOR, METOPROLOL TARTRATE

LOTENSIN HCT, BENAZEPRIL HYDROCHLORIDE

LOTENSIN, BENAZEPRIL HYDROCHLORIDE

LOTREL, AMLODIPINE BESYLATE

METHERGINE, METHYLERGONOVINE MALEATE

METOPIRONE, METYRAPONE

MIACALCIN, CALCITONIN, SALMON

MIOCHOL-E, ACETYLCHOLINE CHLORIDE

MYFORTIC, MYCOPHENOLIC ACID

NEORAL, CYCLOSPORINE

OCUPRESS, CARTEOLOL HYDROCHLORIDE

PARLODEL, BROMOCRIPTINE MESYLATE

RECLAST, ZOLEDRONIC ACID

REGITINE, PHENTOLAMINE MESYLATE

RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE

RITALIN, METHYLPHENIDATE HYDROCHLORIDE

RITALIN-SR, METHYLPHENIDATE HYDROCHLORIDE

SANDIMMUNE, CYCLOSPORINE

SANDOSTATIN LAR, OCTREOTIDE ACETATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

* NOVARTIS PHARMACEUTICALS CORP

SANDOSTATIN, OCTREOTIDE ACETATE

STARLIX, NATEGLINIDE

SULF-10, SULFACETAMIDE SODIUM

TASIGNA, NILOTINIB HYDROCHLORIDE MONOHYDRATE

TAVIST-1, CLEMASTINE FUMARATE (OTC)

TEGRETOL, CARBAMAZEPINE

TEGRETOL-XR, CARBAMAZEPINE

TEKTURNA HCT, ALISKIREN HEMIFUMARATE

TEKTURNA, ALISKIREN HEMIFUMARATE

TRILEPTAL, OXCARBAZEPINE

TYZEKA, TELBIVUDINE

VASOCIDIN, PREDNISOLONE SODIUM PHOSPHATE

VASOCON-A, ANTAZOLINE PHOSPHATE (OTC)

VIVELLE, ESTRADIOL

VIVELLE-DOT, ESTRADIOL

VOLTAREN, DICLOFENAC SODIUM

VOLTAREN-XR, DICLOFENAC SODIUM

ZADITOR, KETOTIFEN FUMARATE (OTC)

ZOMETA, ZOLEDRONIC ACID

NOVARTIS PHARMS

* NOVARTIS PHARMACEUTICALS CORP

FEMARA, LETROZOLE

TOBI, TOBRAMYCIN

NOVEL LABS INC

* NOVEL LABORATORIES INC

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

NOVEN

* NOVEN PHARMACEUTICALS INC

DENTIPATCH, LIDOCAINE

NOVEN THERAP

* NOVEN THERAPEUTICS LLC

ESKALITH, LITHIUM CARBONATE

LITHOBID, LITHIUM CARBONATE

PEXEVA, PAROXETINE MESYLATE

NOVEX

* NOVEX PHARMA

ALBUTEROL SULFATE, ALBUTEROL SULFATE

BETAXOLOL, BETAXOLOL HYDROCHLORIDE

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

CROMOLYN SODIUM, CROMOLYN SODIUM

CYCLOSPORINE, CYCLOSPORINE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LACTULOSE, LACTULOSE

LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE

METAPROTERENOL SULFATE, METAPROTERENOL SULFATE

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

OFLOXACIN, OFLOXACIN

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

TIMOLOL MALEATE, TIMOLOL MALEATE

TOBRAMYCIN, TOBRAMYCIN

NOVO NORDISK

* NOVO NORDISK PHARMACEUTICALS INC

GLUCAGEN, GLUCAGON HYDROCHLORIDE RECOMBINANT

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

NOVO NORDISK INC

* NOVO NORDISK INC

ACTIVELLA, ESTRADIOL

INNOFEM, ESTRADIOL

LEVEMIR, INSULIN DETEMIR RECOMBINANT

NORDITROPIN NORDIFLEX, SOMATROPIN RECOMBINANT

NORDITROPIN, SOMATROPIN RECOMBINANT

NOVOLIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)

NOVOLIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)

NOVOLIN R, INSULIN RECOMBINANT HUMAN (OTC)

NOVOLOG MIX 70/30, INSULIN ASPART PROTAMINE RECOMBINANT

NOVOLOG, INSULIN ASPART RECOMBINANT

PRANDIMET, METFORMIN HYDROCHLORIDE

PRANDIN, REPAGLINIDE

VAGIFEM, ESTRADIOL

NOVOCOL

* NOVOCOL PHARMACEUTICAL INC

ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN, LEVONORDEFRIN

ISOCAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE

NU PHARM

* NU PHARM INC

DIVALPROEX SODIUM, DIVALPROEX SODIUM

NUTRITIONAL RESTART

* NUTRITIONAL RESTART PHARMACEUTICAL LP

NUTRESTORE, GLUTAMINE

NYCOMED US

* NYCOMED US INC

ALVESCO, CICLESONIDE

CALCIPOTRIENE, CALCIPOTRIENE

CICLOPIROX, CICLOPIROX

CLOTRIMAZOLE, CLOTRIMAZOLE

CUTIVATE, FLUTICASONE PROPIONATE

MOMETASONE FUROATE, MOMETASONE FUROATE

OMNARIS, CICLESONIDE

PAMINE FORTE, METHSCOPOLAMINE BROMIDE

PAMINE, METHSCOPOLAMINE BROMIDE

SOLARAZE, DICLOFENAC SODIUM

ZONALON, DOXEPIN HYDROCHLORIDE

ODYSSEY PHARMS

* ODYSSEY PHARMACEUTICALS INC

ANTABUSE, DISULFIRAM

NYSTATIN, NYSTATIN

SURMONTIL, TRIMIPRAMINE MALEATE

URECHOLINE, BETHANECHOL CHLORIDE

VIVACTIL, PROTRIPTYLINE HYDROCHLORIDE

OHM

* OHM CORP

IBUPROFEN, IBUPROFEN (OTC)

OHM LABS

* OHM LABORATORIES INC

ATENOLOL, ATENOLOL

CHLORZOXAZONE, CHLORZOXAZONE

FUROSEMIDE, FUROSEMIDE

IBUPROFEN, IBUPROFEN

IBUPROHM COLD AND SINUS, IBUPROFEN (OTC)

IBUPROHM, IBUPROFEN

IBUPROHM, IBUPROFEN (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

ONY

* ONY INC

INFASURF PRESERVATIVE FREE, CALFACTANT

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** O **

OPTOPICS

* OPTOPICS LABORATORIES CORP

PARACAINE, PROPARACAINE HYDROCHLORIDE

SULFACEL-15, SULFACETAMIDE SODIUM

ORAPHARMA

* ORAPHARMA INC

ARESTIN, MINOCYCLINE HYDROCHLORIDE

ORCHID HLTHCARE

* ORCHID HEALTHCARE

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFAZOLIN, CEFAZOLIN SODIUM

CEFDINIR, CEFDINIR

CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE

CEFOTAXIME SODIUM, CEFOTAXIME SODIUM

CEFOXITIN, CEFOXITIN SODIUM

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFPROZIL, CEFPROZIL

CEFTRIAXONE, CEFTRIAXONE SODIUM

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEFUROXIME SODIUM, CEFUROXIME SODIUM

CEPHALEXIN, CEPHALEXIN

DIVALPROEX SODIUM, DIVALPROEX SODIUM

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

ORGANON USA INC

* ORGANON USA INC

CYCLESSA, DESOGESTREL

DESOGEN, DESOGESTREL

FOLLISTIM AQ, FOLLITROPIN ALFA/BETA

GANIRELIX ACETATE INJECTION, GANIRELIX ACETATE

IMPLANON, ETONOGESTREL

NUVARING, ETHINYL ESTRADIOL

PREGNYL, GONADOTROPIN, CHORIONIC

REMERON SOLTAB, MIRTAZAPINE

REMERON, MIRTAZAPINE

ZEMURON, ROCURONIUM BROMIDE

ORION

* ORION CORP

COMTAN, ENTACAPONE

STALEVO 100, CARBIDOPA

STALEVO 125, CARBIDOPA

STALEVO 150, CARBIDOPA

STALEVO 200, CARBIDOPA

STALEVO 50, CARBIDOPA

STALEVO 75, CARBIDOPA

ORIT LABS LLC

* ORIT LABORATORIES LLC

BENZONATATE, BENZONATATE

ORTHO BIOTECH

* ORTHO BIOTECH PRODUCTS LP

DOXIL, DOXORUBICIN HYDROCHLORIDE

LEUSTATIN, CLADRIBINE

ORTHO MCNEIL JANSSEN

* ORTHO MCNEIL JANSSEN PHARMACEUTICAL INC

CONCERTA, METHYLPHENIDATE HYDROCHLORIDE

HALDOL, HALOPERIDOL DECANOATE

TERAZOL 3, TERCONAZOLE

TYLENOL W/ CODEINE NO. 3, ACETAMINOPHEN

TYLOX, ACETAMINOPHEN

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** O **

* ORTHO MCNEIL JANSSEN PHARMACEUTICAL INC

ULTRACET, ACETAMINOPHEN

* ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC

AXERT, ALMOTRIPTAN MALATE

DITROPAN XL, OXYBUTYNIN CHLORIDE

DITROPAN, OXYBUTYNIN CHLORIDE

DURAGESIC-100, FENTANYL

DURAGESIC-12, FENTANYL

DURAGESIC-25, FENTANYL

DURAGESIC-50, FENTANYL

DURAGESIC-75, FENTANYL

ELMIRON, PENTOSAN POLYSULFATE SODIUM

FLOXIN, OFLOXACIN

HALDOL, HALOPERIDOL LACTATE

INVEGA, PALIPERIDONE

LEVAQUIN, LEVOFLOXACIN

MICRONOR, NORETHINDRONE

MODICON 28, ETHINYL ESTRADIOL

NIZORAL, KETOCONAZOLE

ORTHO CYCLEN-28, ETHINYL ESTRADIOL

ORTHO EVRA, ETHINYL ESTRADIOL

ORTHO TRI-CYCLEN LO, ETHINYL ESTRADIOL

ORTHO TRI-CYCLEN, ETHINYL ESTRADIOL

ORTHO-CEPT, DESOGESTREL

ORTHO-NOVUM 1/35-28, ETHINYL ESTRADIOL

ORTHO-NOVUM 1/50 28, MESTRANOL

ORTHO-NOVUM 10/11-28, ETHINYL ESTRADIOL

ORTHO-NOVUM 7/7/7-28, ETHINYL ESTRADIOL

PARAFON FORTE DSC, CHLORZOXAZONE

RAZADYNE ER, GALANTAMINE HYDROBROMIDE

RAZADYNE, GALANTAMINE HYDROBROMIDE

RISPERDAL CONSTA, RISPERIDONE

RISPERDAL, RISPERIDONE

SPORANOX, ITRACONAZOLE

TAPENTADOL HYDROCHLORIDE, TAPENTADOL HYDROCHLORIDE

TERAZOL 3, TERCONAZOLE

TERAZOL 7, TERCONAZOLE

TOLECTIN 600, TOLMETIN SODIUM

TOLECTIN DS, TOLMETIN SODIUM

TOLECTIN, TOLMETIN SODIUM

TOPAMAX SPRINKLE, TOPIRAMATE

TOPAMAX, TOPIRAMATE

ULTRAM, TRAMADOL HYDROCHLORIDE

URISPAS, FLAVOXATE HYDROCHLORIDE

ORTHO MCNEIL PHARM

* ORTHO MCNEIL PHARMACEUTICAL INC

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

LEVAQUIN, LEVOFLOXACIN

ORTHONEUTROGENA

* ORTHONEUTROGENA

ERTACZO, SERTACONAZOLE NITRATE

GRIFULVIN V, GRISEOFULVIN, MICROCRYSTALLINE

MONISTAT-DERM, MICONAZOLE NITRATE

OSCIENT

* OSCIENT PHARMACEUTICALS

ANTARA (MICRONIZED), FENOFIBRATE

FACTIVE, GEMIFLOXACIN MESYLATE

OSI PHARMS

* OSI PHARMACEUTICALS INC

TARCEVA, ERLOTINIB HYDROCHLORIDE

OSMOTICA PHARM

* OSMOTICA PHARMACEUTICAL CORP

NIFEDIPINE, NIFEDIPINE

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** O **

* OSMOTICA PHARMACEUTICAL CORP

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

OTSUKA

* OTSUKA PHARMACEUTICAL CO LTD

ABILIFY, ARIPIPRAZOLE

PLETAL, CILOSTAZOL

* OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION INC

ABILIFY, ARIPIPRAZOLE

OTSUKA AMERICA

* OTSUKA AMERICA PHARMACEUTICALS INC

BREATHTEK UBT FOR H-PYLORI, UREA, C-13

OTSUKA PHARM

* OTSUKA PHARMACEUTICAL CO LTD

BUSULFEX, BUSULFAN

OUTLOOK PHARMS

* OUTLOOK PHARMACEUTICALS INC

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

OVATION PHARMS

* OVATION PHARMACEUTICALS INC

CHEMET, SUCCIMER

COGENTIN, BENZTROPINE MESYLATE

COSMEGEN, DACTINOMYCIN

DESOXYN, METHAMPHETAMINE HYDROCHLORIDE

DIURIL, CHLOROTHIAZIDE SODIUM

INDOCIN I.V., INDOMETHACIN SODIUM

MUSTARGEN, MECHLORETHAMINE HYDROCHLORIDE

NEMBUTAL SODIUM, PENTOBARBITAL SODIUM

NEOPROFEN, IBUPROFEN LYSINE

PEGANONE, ETHOTOIN

TRANXENE SD, CLORAZEPATE DIPOTASSIUM

TRANXENE, CLORAZEPATE DIPOTASSIUM

PACIFIC PHARMA

* PACIFIC PHARMA

TIMOLOL MALEATE, TIMOLOL MALEATE

* PACIFIC PHARMA INC

TIMOLOL MALEATE, TIMOLOL MALEATE

PACIRA PHARMS INC

* PACIRA PHARMACEUTICALS INC

DEPOCYT, CYTARABINE

DEPODUR, MORPHINE SULFATE

PADDOCK

* PADDOCK LABORATORIES INC

AMMONIUM LACTATE, AMMONIUM LACTATE

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE

CICLOPIROX, CICLOPIROX

CLINDA-DERM, CLINDAMYCIN PHOSPHATE

CLOTRIMAZOLE, CLOTRIMAZOLE

COLISTIMETHATE, COLISTIMETHATE SODIUM

COLOCORT, HYDROCORTISONE

COMPRO, PROCHLORPERAZINE

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

ERYTHRA-DERM, ERYTHROMYCIN

FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE

KIONEX, SODIUM POLYSTYRENE SULFONATE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE

NYSTOP, NYSTATIN

PODOFILOX, PODOFILOX

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PADDOCK LABORATORIES INC

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE

PALADIN LABS

* PALADIN LABS USA INC

ANTIZOL, FOMEPIZOLE

PAR PHARM

* PAR PHARMACEUTICAL

DRONABINOL, DRONABINOL

MELOXICAM, MELOXICAM

NABUMETONE, NABUMETONE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SUMYCIN, TETRACYCLINE HYDROCHLORIDE

* PAR PHARMACEUTICAL INC

AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CABERGOLINE, CABERGOLINE

CAPOTEN, CAPTOPRIL

CARISOPRODOL AND ASPIRIN, ASPIRIN

CEFACLOR, CEFACLOR

CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE

CHOLESTYRAMINE, CHOLESTYRAMINE

CLOMIPHENE CITRATE, CLOMIPHENE CITRATE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE

ESTAZOLAM, ESTAZOLAM

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FLUTAMIDE, FLUTAMIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDRA-ZIDE, HYDRALAZINE HYDROCHLORIDE

HYDROFLUMETHIAZIDE, HYDROFLUMETHIAZIDE

HYDROXYUREA, HYDROXYUREA

IBUPROFEN, IBUPROFEN (OTC)

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MEGACE ES, MEGESTROL ACETATE

MEGESTROL ACETATE, MEGESTROL ACETATE

METAPROTERENOL SULFATE, METAPROTERENOL SULFATE

MINOXIDIL, MINOXIDIL

PROPOXYPHENE HYDROCHLORIDE, PROPOXYPHENE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

SUMYCIN, TETRACYCLINE HYDROCHLORIDE

TORSEMIDE, TORSEMIDE

PARENTA PHARMS

* PARENTA PHARMACEUTICALS INC

ETOMIDATE, ETOMIDATE

PARKE DAVIS

* PARKE DAVIS DIV WARNER LAMBERT CO

CELONTIN, METHSUXIMIDE

CEREBYX, FOSPHENYTOIN SODIUM

CHOLEDYL SA, OXTRIPHYLLINE

DILANTIN, PHENYTOIN SODIUM

DILANTIN-125, PHENYTOIN

NARDIL, PHENELZINE SULFATE

NEURONTIN, GABAPENTIN

ZARONTIN, ETHOSUXIMIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO

ZARONTIN, ETHOSUXIMIDE

PAV NOVA

* PAV NOVA INC

TODAY, NONOXYNOL-9 (OTC)

PEDINOL

* PEDINOL PHARMACAL INC

GRIS-PEG, GRISEOFULVIN, ULTRAMICROCRYSTALLINE

NALFON 200, FENOPROFEN CALCIUM

NALFON, FENOPROFEN CALCIUM

PERRIGO

* L PERRIGO CO

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC)

CAP-PROFEN, IBUPROFEN (OTC)

CHILDREN'S IBUPROFEN, IBUPROFEN (OTC)

CROMOLYN SODIUM, CROMOLYN SODIUM (OTC)

DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC)

FAMOTIDINE, FAMOTIDINE (OTC)

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)

IBUPROFEN, IBUPROFEN (OTC)

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

LORATADINE, LORATADINE (OTC)

MICONAZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

RANITIDINE, RANITIDINE HYDROCHLORIDE (OTC)

TAB-PROFEN, IBUPROFEN (OTC)

TIOCONAZOLE, TIOCONAZOLE (OTC)

* PERRIGO CO

CICLOPIROX, CICLOPIROX

CIMETIDINE, CIMETIDINE (OTC)

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE (OTC)

CLINDETS, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

ERYTHROMYCIN, ERYTHROMYCIN

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

IBUPROFEN, IBUPROFEN (OTC)

JUNIOR STRENGTH IBUPROFEN, IBUPROFEN (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

MICONAZOLE NITRATE COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)

MOMETASONE FUROATE, MOMETASONE FUROATE

NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)

STIE-CORT, HYDROCORTISONE

PERRIGO CO TENNESSEE

* PERRIGO CO TENNESSEE INC

GRISEOFULVIN, GRISEOFULVIN, MICROCRYSTALLINE

PERRIGO ISRAEL

* PERRIGO ISRAEL PHARMACEUTICALS LTD

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

PERRIGO NEW YORK

* PERRIGO NEW YORK INC

AMMONIUM LACTATE, AMMONIUM LACTATE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CENTANY, MUPIROCIN

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

DESONIDE, DESONIDE

DESOXIMETASONE, DESOXIMETASONE

ECONAZOLE NITRATE, ECONAZOLE NITRATE

ERYTHROMYCIN, ERYTHROMYCIN

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

GENTAMICIN, GENTAMICIN SULFATE

HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

HYDROCORTISONE, HYDROCORTISONE

KETOCONAZOLE, KETOCONAZOLE

MESALAMINE, MESALAMINE

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

MOMETASONE FUROATE, MOMETASONE FUROATE

MUPIROCIN, MUPIROCIN

NYSTATIN, NYSTATIN

PERMETHRIN, PERMETHRIN

PERMETHRIN, PERMETHRIN (OTC)

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

SELENIUM SULFIDE, SELENIUM SULFIDE

TERCONAZOLE, TERCONAZOLE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

PERRIGO R AND D

* PERRIGO R AND D CO

CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE, CALCIUM CARBONATE (OTC)

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

GEMFIBROZIL, GEMFIBROZIL

IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC)

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

NAPROXEN, NAPROXEN

NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

SIMVASTATIN, SIMVASTATIN

PERSONAL PRODS

* PERSONAL PRODUCTS CO

MONISTAT 3, MICONAZOLE NITRATE

PFIZER

* PFIZER AGRICULTURAL DIV

ANTIVERT, MECLIZINE HYDROCHLORIDE

* PFIZER CENTRAL RESEARCH

DIFLUCAN, FLUCONAZOLE

ZITHROMAX, AZITHROMYCIN

* PFIZER CHEMICALS DIV PFIZER INC

DIFLUCAN, FLUCONAZOLE

ZITHROMAX, AZITHROMYCIN

* PFIZER INC

ARGATROBAN, ARGATROBAN

CADUET, AMLODIPINE BESYLATE

CARDURA XL, DOXAZOSIN MESYLATE

CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE

DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

DIFLUCAN IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

EXUBERA, INSULIN RECOMBINANT HUMAN

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PFIZER INC

GEODON, ZIPRASIDONE HYDROCHLORIDE

GEODON, ZIPRASIDONE MESYLATE

GLUCOTROL XL, GLIPIZIDE

GLUCOTROL, GLIPIZIDE

LIPITOR, ATORVASTATIN CALCIUM

NAVANE, THIOTHIXENE

NORVASC, AMLODIPINE BESYLATE

PROCARDIA, NIFEDIPINE

REVATIO, SILDENAFIL CITRATE

RID MOUSSE, PIPERONYL BUTOXIDE (OTC)

TOVIAZ, FESOTERODINE FUMARATE

UNASYN, AMPICILLIN SODIUM

VFEND, VORICONAZOLE

ZITHROMAX, AZITHROMYCIN

* PFIZER LABORATORIES DIV PFIZER INC

CARDURA, DOXAZOSIN MESYLATE

DIABINESE, CHLORPROPAMIDE

FELDENE, PIROXICAM

GEOCILLIN, CARBENICILLIN INDANYL SODIUM

MINIPRESS, PRAZOSIN HYDROCHLORIDE

PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM

PERMAPEN, PENICILLIN G BENZATHINE

PFIZERPEN, PENICILLIN G POTASSIUM

PROCARDIA XL, NIFEDIPINE

SELZENTRY, MARAVIROC

SINEQUAN, DOXEPIN HYDROCHLORIDE

STREPTOMYCIN SULFATE, STREPTOMYCIN SULFATE

TERRA-CORTRIL, HYDROCORTISONE ACETATE

TERRAMYCIN W/ POLYMYXIN B SULFATE, OXYTETRACYCLINE HYDROCHLORIDE

UNASYN, AMPICILLIN SODIUM

VIBRAMYCIN, DOXYCYCLINE

VIBRAMYCIN, DOXYCYCLINE CALCIUM

VIBRAMYCIN, DOXYCYCLINE HYCLATE

VIBRA-TABS, DOXYCYCLINE HYCLATE

VISTARIL, HYDROXYZINE HYDROCHLORIDE

VISTARIL, HYDROXYZINE PAMOATE

* PFIZER PHARMACEUTICALS INC

ZOLOFT, SERTRALINE HYDROCHLORIDE

* PFIZER PHARMACEUTICALS PRODUCTION CORP LTD

TIKOSYN, DOFETILIDE

PFIZER GLOBAL

* PFIZER GLOBAL RESEARCH DEVELOPMENT

ZMAX, AZITHROMYCIN

PFIZER INC

* PFIZER INC

CAMPTOSAR, IRINOTECAN HYDROCHLORIDE

CHANTIX, VARENICLINE TARTRATE

ELLENCE, EPIRUBICIN HYDROCHLORIDE

GEODON, ZIPRASIDONE HYDROCHLORIDE

NICOTROL, NICOTINE

PFIZER IRELAND

* PFIZER IRELAND PHARMACEUTICALS

RELPAX, ELETRIPTAN HYDROBROMIDE

VIAGRA, SILDENAFIL CITRATE

PFIZER PHARMS

* PFIZER PHARMACEUTICALS LTD

ACCUPRIL, QUINAPRIL HYDROCHLORIDE

ACCURETIC, HYDROCHLOROTHIAZIDE

DILANTIN, PHENYTOIN

LOPID, GEMFIBROZIL

NEURONTIN, GABAPENTIN

NITROSTAT, NITROGLYCERIN

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

PHARM ASSOC

* PHARMACEUTICAL ASSOC INC

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

PERPHENAZINE, PERPHENAZINE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

* PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

ETHOSUXIMIDE, ETHOSUXIMIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL LACTATE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

LACTULOSE, LACTULOSE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PREDNISOLONE, PREDNISOLONE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

VALPROIC ACID, VALPROIC ACID

PHARM SPEC

* PHARMACEUTICAL SPECIALIST ASSOC

GENTAMICIN SULFATE, GENTAMICIN SULFATE

PHARM VENTURES

* PHARMACEUTICAL VENTURES LTD

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

PHARMA SERVE NY

* PHARMA SERVE INC SUB TORIGIAN LABORATORIES

AMINOPHYLLINE, AMINOPHYLLINE

PHARMACHEMIE

* PHARMACHEMIE BV

CARBOPLATIN, CARBOPLATIN

CISPLATIN, CISPLATIN

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

ETOPOSIDE, ETOPOSIDE

PHARMACHEMIE BV

* PHARMACHEMIE BV

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

PHARMACIA AND UPJOHN

* PHARMACIA AND UPJOHN

XANAX XR, ALPRAZOLAM

* PHARMACIA AND UPJOHN CO

ANSAID, FLURBIPROFEN

AROMASIN, EXEMESTANE

AZULFIDINE EN-TABS, SULFASALAZINE

AZULFIDINE, SULFASALAZINE

BACITRACIN, BACITRACIN

CAVERJECT IMPULSE, ALPROSTADIL

CAVERJECT, ALPROSTADIL

CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE

CLEOCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLEOCIN T, CLINDAMYCIN PHOSPHATE

CLEOCIN, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLEOCIN, CLINDAMYCIN PHOSPHATE

COLESTID, COLESTIPOL HYDROCHLORIDE

CORTEF, HYDROCORTISONE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 94

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PHARMACIA AND UPJOHN CO

CORVERT, IBUTILIDE FUMARATE

CYKLOKAPRON, TRANEXAMIC ACID

DEPO-ESTRADIOL, ESTRADIOL CYPIONATE

DEPO-MEDROL, METHYLPREDNISOLONE ACETATE

DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE

DEPO-TESTOSTERONE, TESTOSTERONE CYPIONATE

DETROL LA, TOLTERODINE TARTRATE

DETROL, TOLTERODINE TARTRATE

DIDREX, BENZPHETAMINE HYDROCHLORIDE

EMCYT, ESTRAMUSTINE PHOSPHATE SODIUM

ESTRING, ESTRADIOL

FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE

GENOTROPIN PRESERVATIVE FREE, SOMATROPIN RECOMBINANT

GENOTROPIN, SOMATROPIN RECOMBINANT

GLYNASE, GLYBURIDE

GLYSET, MIGLITOL

HALCION, TRIAZOLAM

HEMABATE, CARBOPROST TROMETHAMINE

IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE

LINCOCIN, LINCOMYCIN HYDROCHLORIDE

MEDROL, METHYLPREDNISOLONE

MICRONASE, GLYBURIDE

MYCOBUTIN, RIFABUTIN

NICOTROL, NICOTINE

OGEN .625, ESTROPIPATE

OGEN 1.25, ESTROPIPATE

OGEN 2.5, ESTROPIPATE

OGEN 5, ESTROPIPATE

OGEN, ESTROPIPATE

PREPIDIL, DINOPROSTONE

PROSTIN E2, DINOPROSTONE

PROSTIN VR PEDIATRIC, ALPROSTADIL

PROVERA, MEDROXYPROGESTERONE ACETATE

R-GENE 10, ARGININE HYDROCHLORIDE

SOLU-CORTEF, HYDROCORTISONE SODIUM SUCCINATE

SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE

SOMAVERT, PEGVISOMANT

TROBICIN, SPECTINOMYCIN HYDROCHLORIDE

VANTIN, CEFPODOXIME PROXETIL

XALATAN, LATANOPROST

XANAX, ALPRAZOLAM

ZINECARD, DEXRAZOXANE HYDROCHLORIDE

ZYVOX, LINEZOLID

* PHARMACIA AND UPJOHN SUB PFIZER INC

DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE

PHARMADERM

* PHARMADERM DIV ALTANA INC

BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE, BACITRACIN

PHARMAFORCE

* PHARMAFORCE INC

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CAFFEINE CITRATE, CAFFEINE CITRATE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CYCLOSPORINE, CYCLOSPORINE

FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE

FOMEPIZOLE, FOMEPIZOLE

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE

OFLOXACIN, OFLOXACIN

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PHARMAFORCE INC

PHENYTOIN SODIUM, PHENYTOIN SODIUM

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PHARMALUCENCE

* PHARMALUCENCE INC

AN-DTPA, TECHNETIUM TC-99M PENTETATE KIT

AN-SULFUR COLLOID, TECHNETIUM TC-99M SULFUR COLLOID KIT

CIS-MDP, TECHNETIUM TC-99M MEDRONATE KIT

CIS-PYRO, TECHNETIUM TC-99M PYROPHOSPHATE KIT

HEPATOLITE, TECHNETIUM TC-99M DISOFENIN KIT

IOBENGUANE SULFATE I 131, IOBENGUANE SULFATE I 131

PULMOLITE, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

TECHNETIUM TC-99M MEBROFENIN, TECHNETIUM TC-99M MEBROFENIN KIT

PHARMASCIENCE INC

* PHARMASCIENCE INC

CROMOLYN SODIUM, CROMOLYN SODIUM

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

PHARMASEAL

* PHARMASEAL DIV BAXTER HEALTHCARE CORP

PHARMASEAL SCRUB CARE, CHLORHEXIDINE GLUCONATE (OTC)

PHARMATON

* PHARMATON LTD

LIDOCATON, EPINEPHRINE

PHARMAX

* PHARMAX GROUP INC

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

FOLIC ACID, FOLIC ACID

PHARMERAL

* PHARMERAL INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

PHARMION LLC

* PHARMION LLC

VIDAZA, AZACITIDINE

PIERRE FABRE

* PIERRE FABRE MEDICAMENT

NAVELBINE, VINORELBINE TARTRATE

PLANTEX

* PLANTEX USA INC DIV IKAPHARM INC

SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH, SULFAMETHOXAZOLE

PLIVA

* PLIVA INC

AZITHROMYCIN, AZITHROMYCIN

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

CARBOPLATIN, CARBOPLATIN

CHLORPROPAMIDE, CHLORPROPAMIDE

CHLORTHALIDONE, CHLORTHALIDONE

CIMETIDINE, CIMETIDINE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

CYCLOSPORINE, CYCLOSPORINE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

FLUCONAZOLE, FLUCONAZOLE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

KETOCONAZOLE, KETOCONAZOLE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 96

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PLIVA INC

METRONIDAZOLE, METRONIDAZOLE

NAPROXEN, NAPROXEN

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PENTOXIFYLLINE, PENTOXIFYLLINE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

WARFARIN SODIUM, WARFARIN SODIUM

PLIVA HRVATSKA DOO

* PLIVA HRVATSKA DOO

AZITHROMYCIN, AZITHROMYCIN

CARVEDILOL, CARVEDILOL

CILOSTAZOL, CILOSTAZOL

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

RISPERIDONE, RISPERIDONE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

PLIVA LACHEMA

* PLIVA LACHEMA AS

CARBOPLATIN, CARBOPLATIN

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

PACLITAXEL, PACLITAXEL

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PLIVA PHARM IND

* PLIVA PHARMACEUTICAL INDUSTRY INC

TORSEMIDE, TORSEMIDE

POHL BOSKAMP

* POHL BOSKAMP

NITROLINGUAL PUMPSPRAY, NITROGLYCERIN

POLYMEDICA

* POLYMEDICA INDUSTRIES INC

ANESTACON, LIDOCAINE HYDROCHLORIDE

NEOPAP, ACETAMINOPHEN (OTC)

PROMETHACON, PROMETHAZINE HYDROCHLORIDE

POPULATION COUNCIL

* POPULATION COUNCIL CENTER FOR BIOMEDICAL RESEARCH

NORPLANT II, LEVONORGESTREL

PRASCO

* PRASCO LLC DBA PRASCO LABORATORIES

ECONAZOLE NITRATE, ECONAZOLE NITRATE

PRIMAPHARM

* PRIMAPHARM INC

HYDASE, HYALURONIDASE

PRISM PHARMS

* PRISM PHARMACEUTICALS INC

NEXTERONE, AMIODARONE HYDROCHLORIDE

PROCTER AND GAMBLE

* PROCTER AND GAMBLE CO

MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE

* PROCTER AND GAMBLE PHARMACEUTICALS INC

ACTONEL WITH CALCIUM (COPACKAGED), CALCIUM CARBONATE

* PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO

ACTONEL, RISEDRONATE SODIUM

ASACOL, MESALAMINE

DIDRONEL, ETIDRONATE DISODIUM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO

MACROBID, NITROFURANTOIN

PROCTOR AND GAMBLE

* PROCTOR AND GAMBLE PHARMACEUTICALS INC

MESALAMINE, MESALAMINE

PROGENICS

* PROGENICS PHARMACEUTICALS INC

RELISTOR, METHYLNALTREXONE BROMIDE

PROMETHEUS LABS

* PROMETHEUS LABORATORIES INC

HELIDAC, BISMUTH SUBSALICYLATE

IMURAN, AZATHIOPRINE

LOTRONEX, ALOSETRON HYDROCHLORIDE

MERCAPTOPURINE, MERCAPTOPURINE

RIDAURA, AURANOFIN

TRANDATE, LABETALOL HYDROCHLORIDE

ZYLOPRIM, ALLOPURINOL

PROMIUS PHARMA

* PROMIUS PHARMA LLC

ISMO, ISOSORBIDE MONONITRATE

SECTRAL, ACEBUTOLOL HYDROCHLORIDE

TENEX, GUANFACINE HYDROCHLORIDE

PULSION MEDCL

* PULSION MEDICAL SYSTEMS AG

INDOCYANINE GREEN, INDOCYANINE GREEN

PURDUE GMP

* PURDUE GMP CENTER LLC DBA THE CHAO CENTER INDUSTRIAL PHARMACY

SEROMYCIN, CYCLOSERINE

PURDUE PHARM PRODS

* PURDUE PHARMACEUTICAL PRODUCTS LP

DILAUDID, HYDROMORPHONE HYDROCHLORIDE

DILAUDID-HP, HYDROMORPHONE HYDROCHLORIDE

UNIPHYL, THEOPHYLLINE

PURDUE PHARMA LP

* PURDUE PHARMA LP

MS CONTIN, MORPHINE SULFATE

OXYCONTIN, OXYCODONE HYDROCHLORIDE

PUREPAC PHARM

* PUREPAC PHARMACEUTICAL CO

AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE

DIPYRIDAMOLE, DIPYRIDAMOLE

QLT

* QLT INC

VISUDYNE, VERTEPORFIN

QLT USA

* QLT USA INC

ELIGARD, LEUPROLIDE ACETATE

QOL MEDCL

* QOL MEDICAL LLC

ELLIOTTS B SOLUTION, CALCIUM CHLORIDE

ETHAMOLIN, ETHANOLAMINE OLEATE

NASCOBAL, CYANOCOBALAMIN

SUCRAID, SACROSIDASE

QPHARMA

* QPHARMA, LLC

CROMOLYN SODIUM, CROMOLYN SODIUM (OTC)

FLUNISOLIDE, FLUNISOLIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** Q **

QUESTCOR PHARMS

* QUESTCOR PHARMACEUTICALS INC

DORAL, QUAZEPAM

H.P. ACTHAR GEL, CORTICOTROPIN

RANBAXY

* RANBAXY INC

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

* RANBAXY LABORATORIES INC

EURAX, CROTAMITON

EXELDERM, SULCONAZOLE NITRATE

HALOG, HALCINONIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

ISOPTIN SR, VERAPAMIL HYDROCHLORIDE

KENALOG, TRIAMCINOLONE ACETONIDE

LAC-HYDRIN, AMMONIUM LACTATE

ULTRAVATE, HALOBETASOL PROPIONATE

WESTCORT, HYDROCORTISONE VALERATE

* RANBAXY LABORATORIES LTD

ACYCLOVIR, ACYCLOVIR

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

CARBILEV, CARBIDOPA

CARVEDILOL, CARVEDILOL

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFPROZIL, CEFPROZIL

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEPHALEXIN, CEPHALEXIN

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CLARITHROMYCIN, CLARITHROMYCIN

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DISPERMOX, AMOXICILLIN

DOXYCYCLINE, DOXYCYCLINE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

FENOFIBRATE, FENOFIBRATE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FLUCONAZOLE, FLUCONAZOLE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

GABAPENTIN, GABAPENTIN

GANCICLOVIR, GANCICLOVIR

GLIMEPIRIDE, GLIMEPIRIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)

LORATADINE REDIDOSE, LORATADINE (OTC)

LORATADINE, LORATADINE (OTC)

LORAZEPAM, LORAZEPAM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

OFLOXACIN, OFLOXACIN

PANIXINE DISPERDOSE, CEPHALEXIN

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** R **

* RANBAXY LABORATORIES LTD

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)

QUINAPRIL, QUINAPRIL HYDROCHLORIDE

RANICLOR, CEFACLOR

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RANITIDINE, RANITIDINE HYDROCHLORIDE (OTC)

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

SOTRET, ISOTRETINOIN

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

ZIDOVUDINE, ZIDOVUDINE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* RANBAXY PHARMACEUTICALS INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

AVENTYL HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

CEFACLOR, CEFACLOR

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC)

PENTAZOCINE AND NALOXONE HYDROCHLORIDES, NALOXONE HYDROCHLORIDE

RIOMET, METFORMIN HYDROCHLORIDE

SECONAL SODIUM, SECOBARBITAL SODIUM

SOTRET, ISOTRETINOIN

RARE DIS

* RARE DISEASE THERAPEUTICS INC

CYSTADANE, BETAINE HYDROCHLORIDE

RATIOPHARM

* RATIOPHARM GMBH AND CO ARZNEIMITTEL

SUCRALFATE, SUCRALFATE

RECIP

* RECIP AB

THYROSAFE, POTASSIUM IODIDE (OTC)

RECKITT BENCKISER

* RECKITT BENCKISER INC

MUCINEX D, GUAIFENESIN (OTC)

MUCINEX DM, DEXTROMETHORPHAN HYDROBROMIDE (OTC)

MUCINEX, GUAIFENESIN (OTC)

* RECKITT BENCKISER PHARMACEUTICALS INC

BUPRENEX, BUPRENORPHINE HYDROCHLORIDE

SUBOXONE, BUPRENORPHINE HYDROCHLORIDE

SUBUTEX, BUPRENORPHINE HYDROCHLORIDE

REGENT

* REGENT MEDICAL AMERICAS LLC

HIBICLENS, CHLORHEXIDINE GLUCONATE (OTC)

HIBISTAT, CHLORHEXIDINE GLUCONATE (OTC)

RESPIRARE

* RESPIRARE LLC

CROMOLYN SODIUM, CROMOLYN SODIUM

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

RHODIA

* RHODIA LTD

ISOFLURANE, ISOFLURANE

ROCHE

* HOFFMANN LA ROCHE INC

BONIVA, IBANDRONATE SODIUM

COPEGUS, RIBAVIRIN

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 100

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** R **

* HOFFMANN LA ROCHE INC

FANSIDAR, PYRIMETHAMINE

FUZEON, ENFUVIRTIDE

GANTRISIN PEDIATRIC, SULFISOXAZOLE ACETYL

INVIRASE, SAQUINAVIR MESYLATE

KLONOPIN RAPIDLY DISINTEGRATING, CLONAZEPAM

KLONOPIN, CLONAZEPAM

KYTRIL, GRANISETRON HYDROCHLORIDE

TAMIFLU, OSELTAMIVIR PHOSPHATE

VALIUM, DIAZEPAM

VESANOID, TRETINOIN

ROCHE PALO

* ROCHE PALO ALTO LLC

AEROBID, FLUNISOLIDE

ANAPROX DS, NAPROXEN SODIUM

ANAPROX, NAPROXEN SODIUM

CELLCEPT, MYCOPHENOLATE MOFETIL

CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE

CYTOVENE IV, GANCICLOVIR SODIUM

EC-NAPROSYN, NAPROXEN

NAPROSYN, NAPROXEN

TICLID, TICLOPIDINE HYDROCHLORIDE

VALCYTE, VALGANCICLOVIR HYDROCHLORIDE

ROMARK

* ROMARK LABORATORIES

ALINIA, NITAZOXANIDE

ROSEDALE THERAPEUTIC

* ROSEDALE THERAPEUTICS

ERGOMAR, ERGOTAMINE TARTRATE

ROSS LABS

* ROSS LABORATORIES DIV ABBOTT LABORATORIES INC

PEDIAMYCIN 400, ERYTHROMYCIN ETHYLSUCCINATE

PEDIAMYCIN, ERYTHROMYCIN ETHYLSUCCINATE

PEDIAZOLE, ERYTHROMYCIN ETHYLSUCCINATE

SURVANTA, BERACTANT

ROXANE

* ROXANE LABORATORIES INC

ACARBOSE, ACARBOSE

ALPRAZOLAM, ALPRAZOLAM

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AZATHIOPRINE, AZATHIOPRINE

BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

CALCITRIOL, CALCITRIOL

CALCIUM ACETATE, CALCIUM ACETATE

CILOSTAZOL, CILOSTAZOL

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLARITHROMYCIN, CLARITHROMYCIN

CLOTRIMAZOLE, CLOTRIMAZOLE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DEXAMETHASONE INTENSOL, DEXAMETHASONE

DEXAMETHASONE, DEXAMETHASONE

DIAZEPAM INTENSOL, DIAZEPAM

DIAZEPAM, DIAZEPAM

DIGOXIN, DIGOXIN

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FLUCONAZOLE, FLUCONAZOLE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

FUROSEMIDE, FUROSEMIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 101

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** R **

* ROXANE LABORATORIES INC

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LACTULOSE, LACTULOSE

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

LEVETIRACETAM, LEVETIRACETAM

LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE

LITHIUM CARBONATE, LITHIUM CARBONATE

LITHIUM CITRATE, LITHIUM CITRATE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

LORAZEPAM INTENSOL, LORAZEPAM

LORAZEPAM, LORAZEPAM

MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE

MEGESTROL ACETATE, MEGESTROL ACETATE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

MERCAPTOPURINE, MERCAPTOPURINE

METHADONE HYDROCHLORIDE INTENSOL, METHADONE HYDROCHLORIDE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NAPROXEN, NAPROXEN

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXCARBAZEPINE, OXCARBAZEPINE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

PREDNISONE INTENSOL, PREDNISONE

PREDNISONE, PREDNISONE

PROPANTHELINE BROMIDE, PROPANTHELINE BROMIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE

RAMIPRIL, RAMIPRIL

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

ROXICET 5/500, ACETAMINOPHEN

ROXICET, ACETAMINOPHEN

ROXILOX, ACETAMINOPHEN

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

TORSEMIDE, TORSEMIDE

TRIAZOLAM, TRIAZOLAM

ZALEPLON, ZALEPLON

ZIDOVUDINE, ZIDOVUDINE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

RXELITE

* RXELITE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

SAGE PRODS

* SAGE PRODUCTS INC

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC)

SALIX PHARMS

* SALIX PHARMACEUTICALS INC

ANUSOL HC, HYDROCORTISONE

APRISO, MESALAMINE

COLAZAL, BALSALAZIDE DISODIUM

DIURIL, CHLOROTHIAZIDE

MOVIPREP, ASCORBIC ACID

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 102

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SALIX PHARMACEUTICALS INC

OSMOPREP, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

PEPCID, FAMOTIDINE

VISICOL, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

XIFAXAN, RIFAXIMIN

SAMSON MEDCL

* SAMSON MEDICAL TECHNOLOGIES LLC

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

SANDOZ

* SANDOZ CANADA INC

ANECTINE, SUCCINYLCHOLINE CHLORIDE

ARISTOSPAN, TRIAMCINOLONE HEXACETONIDE

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

COSYNTROPIN, COSYNTROPIN

DIGOXIN, DIGOXIN

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

ESTRADIOL VALERATE, ESTRADIOL VALERATE

FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE

FLUMAZENIL, FLUMAZENIL

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HALOPERIDOL, HALOPERIDOL LACTATE

INFUVITE ADULT, ALPHA-TOCOPHEROL ACETATE

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), ASCORBIC ACID

INFUVITE PEDIATRIC, ASCORBIC ACID

ISONIAZID, ISONIAZID

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

REGONOL, PYRIDOSTIGMINE BROMIDE

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

* SANDOZ INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALLOPURINOL, ALLOPURINOL

ALPRAZOLAM, ALPRAZOLAM

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

ATENOLOL, ATENOLOL

AZITHROMYCIN, AZITHROMYCIN

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

BUMETANIDE, BUMETANIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN

CAFERGOT, CAFFEINE

CAPTOPRIL, CAPTOPRIL

CARBIDOPA AND LEVODOPA, CARBIDOPA

CARBOPLATIN, CARBOPLATIN

CARISOPRODOL AND ASPIRIN, ASPIRIN

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 103

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SANDOZ INC

CARISOPRODOL, CARISOPRODOL

CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN

CARVEDILOL, CARVEDILOL

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFDINIR, CEFDINIR

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFPROZIL, CEFPROZIL

CEFTRIAXONE, CEFTRIAXONE SODIUM

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CHLORPROPAMIDE, CHLORPROPAMIDE

CHLORZOXAZONE, CHLORZOXAZONE

CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE

CHOLESTYRAMINE, CHOLESTYRAMINE

CILOSTAZOL, CILOSTAZOL

CIMETIDINE, CIMETIDINE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLARITHROMYCIN EXTENDED RELEASE, CLARITHROMYCIN

CLARITHROMYCIN, CLARITHROMYCIN

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE (OTC)

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM

CORPHED, PSEUDOEPHEDRINE HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

CYCLOSPORINE, CYCLOSPORINE

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

ASPARTATE

DIAZEPAM, DIAZEPAM

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM

DIFLUNISAL, DIFLUNISAL

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATE, ATROPINE SULFATE

DIPYRIDAMOLE, DIPYRIDAMOLE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

EPLERENONE, EPLERENONE

ETODOLAC, ETODOLAC

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

FENOPROFEN CALCIUM, FENOPROFEN CALCIUM

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FLUCONAZOLE, FLUCONAZOLE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE

FLURBIPROFEN, FLURBIPROFEN

FLUTAMIDE, FLUTAMIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 104

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SANDOZ INC

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

FUROSEMIDE, FUROSEMIDE

GABAPENTIN, GABAPENTIN

GEMFIBROZIL, GEMFIBROZIL

GLIPIZIDE, GLIPIZIDE

GLYBURIDE (MICRONIZED), GLYBURIDE

HALOPERIDOL, HALOPERIDOL

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

INDAPAMIDE, INDAPAMIDE

INDOCIN SR, INDOMETHACIN

INDOMETHACIN, INDOMETHACIN

INVAGESIC FORTE, ASPIRIN

INVAGESIC, ASPIRIN

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

ISONIAZID, ISONIAZID

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

ITRACONAZOLE, ITRACONAZOLE

KETOPROFEN, KETOPROFEN

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LAMOTRIGINE, LAMOTRIGINE

LEFLUNOMIDE, LEFLUNOMIDE

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

LEVETIRACETAM, LEVETIRACETAM

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LOCHOLEST LIGHT, CHOLESTYRAMINE

LOCHOLEST, CHOLESTYRAMINE

LONOX, ATROPINE SULFATE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

LORATADINE, LORATADINE (OTC)

LORAZEPAM, LORAZEPAM

LOVASTATIN, LOVASTATIN

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM

MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHAZOLAMIDE, METHAZOLAMIDE

METHIMAZOLE, METHIMAZOLE

METHOCARBAMOL, METHOCARBAMOL

METHYCLOTHIAZIDE, METHYCLOTHIAZIDE

METHYLDOPA, METHYLDOPA

METHYLPREDNISOLONE, METHYLPREDNISOLONE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOLAZONE, METOLAZONE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METRONIDAZOLE, METRONIDAZOLE

MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NABUMETONE, NABUMETONE

NADOLOL, NADOLOL

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 105

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SANDOZ INC

NAFCILLIN SODIUM, NAFCILLIN SODIUM

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NAPROXEN, NAPROXEN

NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

NIZATIDINE, NIZATIDINE

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

OFLOXACIN, OFLOXACIN

OMEPRAZOLE, OMEPRAZOLE

OMNITROPE, SOMATROPIN RECOMBINANT

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE, ASPIRIN

OXACILLIN SODIUM, OXACILLIN SODIUM

OXANDROLONE, OXANDROLONE

OXAPROZIN, OXAPROZIN

OXAZEPAM, OXAZEPAM

PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM

PENICILLIN G SODIUM, PENICILLIN G SODIUM

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

PERPHENAZINE, PERPHENAZINE

PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PINDOLOL, PINDOLOL

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

PREDNISONE, PREDNISONE

PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, ACETAMINOPHEN

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE, PSEUDOEPHEDRINE

HYDROCHLORIDE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

QUINIDINE SULFATE, QUINIDINE SULFATE

RAMIPRIL, RAMIPRIL

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RANITIDINE, RANITIDINE HYDROCHLORIDE (OTC)

RESERPINE, RESERPINE

RIBAVIRIN, RIBAVIRIN

RIFAMPIN, RIFAMPIN

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

SPIRONOLACTONE, SPIRONOLACTONE

SULFADIAZINE, SULFADIAZINE

SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SULINDAC, SULINDAC

TEMAZEPAM, TEMAZEPAM

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

THIOTHIXENE, THIOTHIXENE

TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE

TIMOLOL MALEATE, TIMOLOL MALEATE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOLAZAMIDE, TOLAZAMIDE

TOLBUTAMIDE, TOLBUTAMIDE

TOLMETIN SODIUM, TOLMETIN SODIUM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SANDOZ INC

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

WARFARIN SODIUM, WARFARIN SODIUM

ZALEPLON, ZALEPLON

ZONISAMIDE, ZONISAMIDE

SANOFI AVENTIS US

* SANOFI AVENTIS US LLC

ALLEGRA D 24 HOUR, FEXOFENADINE HYDROCHLORIDE

ALLEGRA, FEXOFENADINE HYDROCHLORIDE

ALLEGRA-D 12 HOUR, FEXOFENADINE HYDROCHLORIDE

AMARYL, GLIMEPIRIDE

AMBIEN CR, ZOLPIDEM TARTRATE

AMBIEN, ZOLPIDEM TARTRATE

ANZEMET, DOLASETRON MESYLATE

APIDRA, INSULIN GLULISINE RECOMBINANT

ARALEN, CHLOROQUINE PHOSPHATE

ARAVA, LEFLUNOMIDE

AVALIDE, HYDROCHLOROTHIAZIDE

AVAPRO, IRBESARTAN

BENZACLIN, BENZOYL PEROXIDE

BENZAMYCIN PAK, BENZOYL PEROXIDE

BENZAMYCIN, BENZOYL PEROXIDE

CANTIL, MEPENZOLATE BROMIDE

CARAC, FLUOROURACIL

CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER, CEFOTAXIME SODIUM

CLAFORAN, CEFOTAXIME SODIUM

CLOMID, CLOMIPHENE CITRATE

DDAVP (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

DDAVP, DESMOPRESSIN ACETATE

DEMEROL, MEPERIDINE HYDROCHLORIDE

DERMATOP E EMOLLIENT, PREDNICARBATE

DERMATOP, PREDNICARBATE

DIABETA, GLYBURIDE

DRISDOL, ERGOCALCIFEROL

ELOXATIN, OXALIPLATIN

GAVISCON, ALUMINUM HYDROXIDE (OTC)

HIPREX, METHENAMINE HIPPURATE

HYTONE, HYDROCORTISONE

KAYEXALATE, SODIUM POLYSTYRENE SULFONATE

KERLONE, BETAXOLOL HYDROCHLORIDE

KETEK, TELITHROMYCIN

KLARON, SULFACETAMIDE SODIUM

LANTUS, INSULIN GLARGINE RECOMBINANT

LASIX, FUROSEMIDE

LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM

LOVENOX, ENOXAPARIN SODIUM

MYTELASE, AMBENONIUM CHLORIDE

NASACORT AQ, TRIAMCINOLONE ACETONIDE

NEGGRAM, NALIDIXIC ACID

NICODERM CQ, NICOTINE (OTC)

NILANDRON, NILUTAMIDE

NORITATE, METRONIDAZOLE

NORPRAMIN, DESIPRAMINE HYDROCHLORIDE

PENLAC, CICLOPIROX

PHISOHEX, HEXACHLOROPHENE

PLAQUENIL, HYDROXYCHLOROQUINE SULFATE

PLAVIX, CLOPIDOGREL BISULFATE

PRIFTIN, RIFAPENTINE

PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 107

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SANOFI AVENTIS US LLC

PRIMAQUINE, PRIMAQUINE PHOSPHATE

PSORCON, DIFLORASONE DIACETATE

RIFADIN, RIFAMPIN

RIFAMATE, ISONIAZID

RIFATER, ISONIAZID

RILUTEK, RILUZOLE

SKELID, TILUDRONATE DISODIUM

TALACEN, ACETAMINOPHEN

TALWIN NX, NALOXONE HYDROCHLORIDE

TAXOTERE, DOCETAXEL

TRENTAL, PENTOXIFYLLINE

UROXATRAL, ALFUZOSIN HYDROCHLORIDE

SANTARUS

* SANTARUS INC

ZEGERID, MAGNESIUM HYDROXIDE

ZEGERID, OMEPRAZOLE

SANTEN

* SANTEN INC

ALAMAST, PEMIROLAST POTASSIUM

IQUIX, LEVOFLOXACIN

QUIXIN, LEVOFLOXACIN

SANTEN OY

* SANTEN OY

BETIMOL, TIMOLOL

SAVAGE LABS

* SAVAGE LABORATORIES INC DIV ALTANA INC

ETHIODOL, ETHIODIZED OIL

KAON CL-10, POTASSIUM CHLORIDE

PANDEL, HYDROCORTISONE PROBUTATE

SAVIENT PHARMS

* SAVIENT PHARMACEUTICALS INC

OXANDRIN, OXANDROLONE

SB PHARMCO

* SB PHARMCO PUERTO RICO INC

AVANDAMET, METFORMIN HYDROCHLORIDE

AVANDARYL, GLIMEPIRIDE

AVANDIA, ROSIGLITAZONE MALEATE

COREG CR, CARVEDILOL PHOSPHATE

SCHERER RP

* RP SCHERER NORTH AMERICA DIV RP SCHERER CORP

DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATE, ATROPINE SULFATE

SCHERING

* SCHERING

ASMANEX TWISTHALER, MOMETASONE FUROATE

CLARINEX, DESLORATADINE

CLARINEX-D 12 HOUR, DESLORATADINE

* SCHERING CORP

CLARINEX D 24 HOUR, DESLORATADINE

CLARINEX, DESLORATADINE

DIPROLENE AF, BETAMETHASONE DIPROPIONATE

GUANIDINE HYDROCHLORIDE, GUANIDINE HYDROCHLORIDE

INTEGRILIN, EPTIFIBATIDE

LOTRISONE, BETAMETHASONE DIPROPIONATE

NOXAFIL, POSACONAZOLE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

REBETOL, RIBAVIRIN

TEMODAR, TEMOZOLOMIDE

* SCHERING CORP SUB SCHERING PLOUGH CORP

CELESTONE SOLUSPAN, BETAMETHASONE ACETATE

CELESTONE, BETAMETHASONE

DIPROLENE, BETAMETHASONE DIPROPIONATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SCHERING CORP SUB SCHERING PLOUGH CORP

ELOCON, MOMETASONE FUROATE

SCHERING PLOUGH

* SCHERING PLOUGH CORP

CLARINEX, DESLORATADINE

* SCHERING PLOUGH HEALTHCARE PRODUCTS INC

AFRINOL, PSEUDOEPHEDRINE SULFATE (OTC)

CHILDREN'S CLARITIN, LORATADINE (OTC)

CHLOR-TRIMETON, CHLORPHENIRAMINE MALEATE (OTC)

CLARITIN HIVES RELIEF REDITAB, LORATADINE (OTC)

CLARITIN HIVES RELIEF, LORATADINE (OTC)

CLARITIN REDITABS, LORATADINE (OTC)

CLARITIN, LORATADINE (OTC)

CLARITIN-D 24 HOUR, LORATADINE (OTC)

DISOPHROL, DEXBROMPHENIRAMINE MALEATE (OTC)

DRIXORAL PLUS, ACETAMINOPHEN (OTC)

DRIXORAL, DEXBROMPHENIRAMINE MALEATE (OTC)

GYNE-LOTRIMIN 3 COMBINATION PACK, CLOTRIMAZOLE (OTC)

GYNE-LOTRIMIN 3, CLOTRIMAZOLE (OTC)

GYNE-LOTRIMIN COMBINATION PACK, CLOTRIMAZOLE (OTC)

GYNE-LOTRIMIN, CLOTRIMAZOLE (OTC)

LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE (OTC)

MIRALAX, POLYETHYLENE GLYCOL 3350 (OTC)

NASONEX, MOMETASONE FUROATE MONOHYDRATE

OCUCLEAR, OXYMETAZOLINE HYDROCHLORIDE (OTC)

SHADE UVAGUARD, AVOBENZONE (OTC)

SCHERING PLOUGH RES

* SCHERING PLOUGH RESEARCH INSTITUTE

LOTRISONE, BETAMETHASONE DIPROPIONATE

REBETOL, RIBAVIRIN

SCHWARZ

* SCHWARZ GMBH

MONOKET, ISOSORBIDE MONONITRATE

SCHWARZ BIOSCIENCES

* SCHWARZ BIOSCIENCES INC

VIMPAT, LACOSAMIDE

SCHWARZ PHARMA

* SCHWARZ PHARMA AG

EDEX, ALPROSTADIL

GLYCOLAX, POLYETHYLENE GLYCOL 3350

* SCHWARZ PHARMA INC

CO-GESIC, ACETAMINOPHEN

COLYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350

COLYTE, POLYETHYLENE GLYCOL 3350

COLYTE-FLAVORED, POLYETHYLENE GLYCOL 3350

CORTIFOAM, HYDROCORTISONE ACETATE

DILATRATE-SR, ISOSORBIDE DINITRATE

EPIFOAM, HYDROCORTISONE ACETATE

FLUXID, FAMOTIDINE

KEMSTRO, BACLOFEN

LEVATOL, PENBUTOLOL SULFATE

NIRAVAM, ALPRAZOLAM

PARCOPA, CARBIDOPA

PROCTOFOAM HC, HYDROCORTISONE ACETATE

ROBAXIN, METHOCARBAMOL

ROBAXIN-750, METHOCARBAMOL

TRILYTE, POLYETHYLENE GLYCOL 3350

UNIRETIC, HYDROCHLOROTHIAZIDE

UNIVASC, MOEXIPRIL HYDROCHLORIDE

SCIELE PHARMA INC

* SCIELE PHARMA INC

CEDAX, CEFTIBUTEN DIHYDRATE

COGNEX, TACRINE HYDROCHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 109

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SCIELE PHARMA INC

FENOGLIDE, FENOFIBRATE

FURADANTIN, NITROFURANTOIN

PONSTEL, MEFENAMIC ACID

ROBINUL FORTE, GLYCOPYRROLATE

ROBINUL, GLYCOPYRROLATE

SULAR, NISOLDIPINE

SCIOS

* SCIOS INC

NATRECOR, NESIRITIDE RECOMBINANT

SEPRACOR

* SEPRACOR INC

BROVANA, ARFORMOTEROL TARTRATE

LUNESTA, ESZOPICLONE

XOPENEX HFA, LEVALBUTEROL TARTRATE

XOPENEX, LEVALBUTEROL HYDROCHLORIDE

SEPTODONT

* SEPTODONT INC

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

OCTOCAINE, EPINEPHRINE

SHIRE

* SHIRE DEVELOPMENT INC

ADDERALL XR 10, AMPHETAMINE ASPARTATE

ADDERALL XR 15, AMPHETAMINE ASPARTATE

ADDERALL XR 20, AMPHETAMINE ASPARTATE

ADDERALL XR 25, AMPHETAMINE ASPARTATE

ADDERALL XR 30, AMPHETAMINE ASPARTATE

ADDERALL XR 5, AMPHETAMINE ASPARTATE

AGRYLIN, ANAGRELIDE HYDROCHLORIDE

CARBATROL, CARBAMAZEPINE

DAYTRANA, METHYLPHENIDATE

DEXTROSTAT, DEXTROAMPHETAMINE SULFATE

FOSRENOL, LANTHANUM CARBONATE

LIALDA, MESALAMINE

PENTASA, MESALAMINE

PROAMATINE, MIDODRINE HYDROCHLORIDE

SALURON, HYDROFLUMETHIAZIDE

SIEGFRIED

* SIEGFRIED LTD

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

SIGHT PHARMS

* SIGHT PHARMACEUTICALS INC

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)

SIGMA TAU

* SIGMA TAU PHARMACEUTICALS INC

CARNITOR SF, LEVOCARNITINE

CARNITOR, LEVOCARNITINE

MATULANE, PROCARBAZINE HYDROCHLORIDE

SILARX

* SILARX PHARMACEUTICALS INC

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL LACTATE

LORATADINE, LORATADINE (OTC)

METAPROTERENOL SULFATE, METAPROTERENOL SULFATE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 110

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

SIRION THERAP

* SIRION THERAPEUTICS INC

DUREZOL, DIFLUPREDNATE

SIRIUS LABS

* SIRIUS LABORATORIES INC

TEXACORT, HYDROCORTISONE

SKINMEDICA

* SKINMEDICA INC

DESONATE, DESONIDE

VANIQA, EFLORNITHINE HYDROCHLORIDE

SKYEPHARMA AG

* SKYEPHARMA AG

TRIGLIDE, FENOFIBRATE

SMITHKLINE BEECHAM

* SMITHKLINE BEECHAM

LOVAZA, OMEGA-3-ACID ETHYL ESTERS

* SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE

ARRANON, NELARABINE

AUGMENTIN ES-600, AMOXICILLIN

AXID, NIZATIDINE

COREG, CARVEDILOL

DEXEDRINE, DEXTROAMPHETAMINE SULFATE

DYNACIRC CR, ISRADIPINE

EPZICOM, ABACAVIR SULFATE

HYCAMTIN, TOPOTECAN HYDROCHLORIDE

INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE

LANOXICAPS, DIGOXIN

LANOXIN, DIGOXIN

LEUKERAN, CHLORAMBUCIL

REQUIP XL, ROPINIROLE HYDROCHLORIDE

RYTHMOL SR, PROPAFENONE HYDROCHLORIDE

RYTHMOL, PROPAFENONE HYDROCHLORIDE

TYKERB, LAPATINIB DITOSYLATE

WELLBUTRIN XL, BUPROPION HYDROCHLORIDE

SOAPCO

* SOAPCO INC

BRIAN CARE, CHLORHEXIDINE GLUCONATE (OTC)

SOLUMED

* LES ENTREPRISES SOLUMED INC

CHLORASCRUB MAXI SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

CHLORASCRUB SWAB, CHLORHEXIDINE GLUCONATE (OTC)

CHLORASCRUB SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

SOLVAY PHARMS

* SOLVAY PHARMACEUTICALS INC

ACEON, PERINDOPRIL ERBUMINE

SOMERSET

* SOMERSET PHARMACEUTICALS INC

ELDEPRYL, SELEGILINE HYDROCHLORIDE

EMSAM, SELEGILINE

SPEAR PHARMS

* SPEAR PHARMACEUTICALS INC

FLUOROURACIL, FLUOROURACIL

TRETINOIN, TRETINOIN

SPECTRUM PHARMS

* SPECTRUM PHARMACEUTICALS

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

* SPECTRUM PHARMACEUTICALS INC

CARBOPLATIN, CARBOPLATIN

FUSILEV, LEVOLEUCOVORIN CALCIUM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

STAND HOMEOPATH

* STANDARD HOMEOPATHIC CO

IVY BLOCK, BENTOQUATAM (OTC)

STAR PHARMS FL

* STAR PHARMACEUTICALS INC

VIRILON, METHYLTESTOSTERONE

STASON

* STASON INDUSTRIAL CORP

ACYCLOVIR, ACYCLOVIR

CAPTOPRIL, CAPTOPRIL

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

STASON PHARMS

* STASON PHARMACEUTICALS INC

CYPROHEPTADINE HYDROCLORIDE, CYPROHEPTADINE HYDROCHLORIDE

STAT TRADE

* STAT TRADE INC

NAPRELAN, NAPROXEN SODIUM

STAT-TRADE

* STAT-TRADE INC

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

DEXAMETHASONE, DEXAMETHASONE

MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE

TRIACIN-C, CODEINE PHOSPHATE

STEVENS J

* JEROME STEVENS PHARMACEUTICALS INC

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN

CEPHALEXIN, CEPHALEXIN

DIGOXIN, DIGOXIN

METHOCARBAMOL AND ASPIRIN, ASPIRIN

ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE, ASPIRIN

UNITHROID, LEVOTHYROXINE SODIUM

STIEFEL

* STIEFEL LABORATORIES INC

DECLOMYCIN, DEMECLOCYCLINE HYDROCHLORIDE

DUAC, BENZOYL PEROXIDE

HYDROCORTISONE, HYDROCORTISONE

STIEFEL LABS INC

* STIEFEL LABORATORIES INC

E-GLADES, ERYTHROMYCIN

EVOCLIN, CLINDAMYCIN PHOSPHATE

EXTINA, KETOCONAZOLE

LUXIQ, BETAMETHASONE VALERATE

OLUX E, CLOBETASOL PROPIONATE

SORIATANE, ACITRETIN

VERDESO, DESONIDE

STRAKAN

* STRAKAN INTERNATIONAL LTD

SANCUSO, GRANISETRON

SUCAMPO PHARMS

* SUCAMPO PHARMACEUTICALS INC

AMITIZA, LUBIPROSTONE

SUMMERS

* SUMMERS LABORATORIES INC

CROTAN, CROTAMITON

SUN PHARM INDS

* SUN PHARMACEUTICAL INDUSTRIES LTD

ALENDRONATE SODIUM, ALENDRONATE SODIUM

AMIFOSTINE, AMIFOSTINE

CARBIDOPA AND LEVODOPA, CARBIDOPA

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 112

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SUN PHARMACEUTICAL INDUSTRIES LTD

CARBOPLATIN, CARBOPLATIN

DIVALPROEX SODIUM, DIVALPROEX SODIUM

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

ONDANSETRON, ONDANSETRON

OXCARBAZEPINE, OXCARBAZEPINE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

TORSEMIDE, TORSEMIDE

SUN PHARM INDS (IN)

* SUN PHARMACEUTICAL INDUSTRIES LTD

CEPHALEXIN, CEPHALEXIN

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ORTHO-EST, ESTROPIPATE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

ZONISAMIDE, ZONISAMIDE

SUN PHARM INDS INC

* SUN PHARMACEUTICAL INDUSTRIES INC

BENZONATATE, BENZONATATE

GEMFIBROZIL, GEMFIBROZIL

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

NIMODIPINE, NIMODIPINE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

SUN PHARM INDS LTD

* SUN PHARMACEUTICAL INDUSTRIES LTD

CARISOPRODOL, CARISOPRODOL

GABAPENTIN, GABAPENTIN

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

SUN PHARMA GLOBAL

* SUN PHARMA GLOBAL INC

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

SUPPOSITORIA

* SUPPOSITORIA LABORATORIES INC

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

SWEDISH ORPHAN

* SWEDISH ORPHAN AB

ORFADIN, NITISINONE

SYNCOR PHARMS

* SYNCOR PHARMACEUTICALS INC

SODIUM IODIDE I 123, SODIUM IODIDE, I-123

SYNERX PHARMA

* SYNERX PHARMA LLC

CICLOPIROX, CICLOPIROX

FOMEPIZOLE, FOMEPIZOLE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

SYNTHON LAB

* SYNTHON LABORATORIES INC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

SYNTHON PHARMS

* SYNTHON PHARMACEUTICALS LTD

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

B - 113

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

TAKEDA GLOBAL

* TAKEDA GLOBAL RESEARCH DEVELOPMENT CENTER INC

ACTOPLUS MET, METFORMIN HYDROCHLORIDE

DUETACT, GLIMEPIRIDE

ROZEREM, RAMELTEON

TAKEDA PHARMS NA

* TAKEDA PHARMACEUTICALS NORTH AMERICA INC

ACTOS, PIOGLITAZONE HYDROCHLORIDE

PREVACID IV, LANSOPRAZOLE

PREVACID NAPRAPAC 500 (COPACKAGED), LANSOPRAZOLE

PREVACID, LANSOPRAZOLE

PREVPAC, AMOXICILLIN

TARGACEPT

* TARGACEPT INC

INVERSINE, MECAMYLAMINE HYDROCHLORIDE

TARO

* TARO PHARMACEUTICAL INDUSTRIES LTD

ACETAZOLAMIDE, ACETAZOLAMIDE

CARBAMAZEPINE, CARBAMAZEPINE

CARVEDILOL, CARVEDILOL

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ETODOLAC, ETODOLAC

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

FLUCONAZOLE, FLUCONAZOLE

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

KETOCONAZOLE, KETOCONAZOLE

LORATADINE, LORATADINE (OTC)

MELOXICAM, MELOXICAM

METRONIDAZOLE, METRONIDAZOLE

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXCARBAZEPINE, OXCARBAZEPINE

PHENYTOIN, PHENYTOIN

TERIL, CARBAMAZEPINE

* TARO PHARMACEUTICALS INC

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE, CLOTRIMAZOLE

CLOTRIMAZOLE, CLOTRIMAZOLE (OTC)

DESOXIMETASONE, DESOXIMETASONE

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE, FLUOCINONIDE

HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

WARFARIN SODIUM, WARFARIN SODIUM

* TARO PHARMACEUTICALS USA INC

ACETIC ACID, ACETIC ACID, GLACIAL

ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMMONIUM LACTATE, AMMONIUM LACTATE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CICLOPIROX, CICLOPIROX

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TARO PHARMACEUTICALS USA INC

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CLOTRIMAZOLE, CLOTRIMAZOLE

DERMABET, BETAMETHASONE VALERATE

DESONIDE, DESONIDE

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

ECONAZOLE NITRATE, ECONAZOLE NITRATE

FLO-PRED, PREDNISOLONE ACETATE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE

FLUOCINONIDE, FLUOCINONIDE

FLUOROURACIL, FLUOROURACIL

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL

HYDROCORTISONE, HYDROCORTISONE

KETOZOLE, KETOCONAZOLE

LIDOCAINE, LIDOCAINE

LORATADINE, LORATADINE (OTC)

MICONAZOLE 3, MICONAZOLE NITRATE (OTC)

MOMETASONE FUROATE, MOMETASONE FUROATE

MUPIROCIN, MUPIROCIN

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

NYSTATIN, NYSTATIN

ORACORT, TRIAMCINOLONE ACETONIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE (OTC)

TERCONAZOLE, TERCONAZOLE

TERIL, CARBAMAZEPINE

THEOPHYLLINE, THEOPHYLLINE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TRIVAGIZOLE 3, CLOTRIMAZOLE (OTC)

U-CORT, HYDROCORTISONE ACETATE

TARO PHARM INDS

* TARO PHARMACEUTICAL INDUSTRIES LTD

AMCINONIDE, AMCINONIDE

CARBAMAZEPINE, CARBAMAZEPINE

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

ETODOLAC, ETODOLAC

FLUCONAZOLE, FLUCONAZOLE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

TARO PHARMS IRELAND

* TARO PHARMACEUTICALS IRELAND LTD

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, WATER FOR INJECTION, STERILE

TARO PHARMS NORTH

* TARO PHARMACEUTICALS NORTH AMERICA INC

OVIDE, MALATHION

TOPICORT LP, DESOXIMETASONE

TOPICORT, DESOXIMETASONE

TAYLOR

* TAYLOR PHARMACEUTICALS

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

NAPHAZOLINE HYDROCHLORIDE, NAPHAZOLINE HYDROCHLORIDE

TAYLOR PHARMA

* TAYLOR PHARMACAL CO

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TAYLOR PHARMACAL CO

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

TEDOR PHARM

* TEDOR PHARMA, INC.

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

TEIKOKU PHARMA USA

* TEIKOKU PHARMA USA INC

LIDODERM, LIDOCAINE

TERCICA

* TERCICA INC

INCRELEX, MECASERMIN RECOMBINANT

TEVA

* TEVA NEUROSCIENCE INC

AZILECT, RASAGILINE MESYLATE

COPAXONE, GLATIRAMER ACETATE

* TEVA PHARMACEUTICALS USA INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACYCLOVIR, ACYCLOVIR

ADIPEX-P, PHENTERMINE HYDROCHLORIDE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN PEDIATRIC, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

ATENOLOL, ATENOLOL

AZITHROMYCIN, AZITHROMYCIN

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BETA-VAL, BETAMETHASONE VALERATE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CALCITRIOL, CALCITRIOL

CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL

CAPTOPRIL, CAPTOPRIL

CARBIDOPA AND LEVODOPA, CARBIDOPA

CARVEDILOL, CARVEDILOL

CEFACLOR, CEFACLOR

CEFPROZIL, CEFPROZIL

CEFTRIAXONE, CEFTRIAXONE SODIUM

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEFUROXIME SODIUM, CEFUROXIME SODIUM

CEPHALEXIN, CEPHALEXIN

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

CHLORZOXAZONE, CHLORZOXAZONE

CILOSTAZOL, CILOSTAZOL

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

CIMETIDINE, CIMETIDINE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLARITHROMYCIN, CLARITHROMYCIN

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

CLOTRIMAZOLE, CLOTRIMAZOLE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM

DIFLUNISAL, DIFLUNISAL

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TEVA PHARMACEUTICALS USA INC

ENALAPRIL MALEATE, ENALAPRIL MALEATE

EPITOL, CARBAMAZEPINE

ESTAZOLAM, ESTAZOLAM

ETODOLAC, ETODOLAC

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FENOFIBRATE, FENOFIBRATE

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FINASTERIDE, FINASTERIDE

FLUCONAZOLE, FLUCONAZOLE

FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE

FLUOCINONIDE, FLUOCINONIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLURBIPROFEN, FLURBIPROFEN

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

GABAPENTIN, GABAPENTIN

GALZIN, ZINC ACETATE

GEMFIBROZIL, GEMFIBROZIL

GLIMEPIRIDE, GLIMEPIRIDE

GLYBURIDE (MICRONIZED), GLYBURIDE

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GLYBURIDE, GLYBURIDE

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

KETOCONAZOLE, KETOCONAZOLE

KETOPROFEN, KETOPROFEN

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LAMOTRIGINE, LAMOTRIGINE

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

LORATADINE, LORATADINE (OTC)

LOVASTATIN, LOVASTATIN

MESALAMINE, MESALAMINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOLAZONE, METOLAZONE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METRONIDAZOLE, METRONIDAZOLE

MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

MIRTAZAPINE, MIRTAZAPINE

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE

MUPIROCIN, MUPIROCIN

NABUMETONE, NABUMETONE

NAPROXEN SODIUM, NAPROXEN SODIUM

NAPROXEN, NAPROXEN

NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE

NEOMYCIN SULFATE, NEOMYCIN SULFATE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NIZATIDINE, NIZATIDINE

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

NYSTATIN, NYSTATIN

OFLOXACIN, OFLOXACIN

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

ORAP, PIMOZIDE

OXAPROZIN, OXAPROZIN

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TEVA PHARMACEUTICALS USA INC

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PENICILLIN-VK, PENICILLIN V POTASSIUM

PIROXICAM, PIROXICAM

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PRELONE, PREDNISOLONE

PROPOXYPHENE HYDROCHLORIDE, PROPOXYPHENE HYDROCHLORIDE

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, ACETAMINOPHEN

PURINETHOL, MERCAPTOPURINE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RIBAVIRIN, RIBAVIRIN

RISPERIDONE, RISPERIDONE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

SUCRALFATE, SUCRALFATE

SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOLMETIN SODIUM, TOLMETIN SODIUM

TORSEMIDE, TORSEMIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TRIACET, TRIAMCINOLONE ACETONIDE

TRIMETHOPRIM, TRIMETHOPRIM

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

TEVA GLOBAL

* TEVA GLOBAL RESPIRATORY RESEARCH LLC

NASAREL, FLUNISOLIDE

PROAIR HFA, ALBUTEROL SULFATE

PROGLYCEM, DIAZOXIDE

QVAR 40, BECLOMETHASONE DIPROPIONATE

QVAR 80, BECLOMETHASONE DIPROPIONATE

TEVA PARENTERAL

* TEVA PARENTERAL MEDICINES INC

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM

ACYCLOVIR, ACYCLOVIR SODIUM

ADENOSINE, ADENOSINE

ALPROSTADIL, ALPROSTADIL

AMIKACIN SULFATE, AMIKACIN SULFATE

AMINOPHYLLINE, AMINOPHYLLINE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMPHOTERICIN B, AMPHOTERICIN B

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

AZITHROMYCIN, AZITHROMYCIN

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

BUMETANIDE, BUMETANIDE

CALCITRIOL, CALCITRIOL

CARBOPLATIN, CARBOPLATIN

CEFTRIAXONE, CEFTRIAXONE SODIUM

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CIPROFLOXACIN, CIPROFLOXACIN

CISPLATIN, CISPLATIN

CYTOSAR-U, CYTARABINE

DACARBAZINE, DACARBAZINE

DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE

DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TEVA PARENTERAL MEDICINES INC

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

ENALAPRILAT, ENALAPRILAT

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM

ERYTHROMYCIN LACTOBIONATE, ERYTHROMYCIN LACTOBIONATE

ETOPOSIDE, ETOPOSIDE

FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FLUMAZENIL, FLUMAZENIL

FLUOROURACIL, FLUOROURACIL

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HALOPERIDOL, HALOPERIDOL LACTATE

IDARUBICIN HYDROCHLORIDE PFS, IDARUBICIN HYDROCHLORIDE

IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE

IFOSFAMIDE/MESNA KIT, IFOSFAMIDE

IFSOFAMIDE, IFOSFAMIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

LEVOCARNITINE, LEVOCARNITINE

MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

MESNA, MESNA

METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE

METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE

OXYTOCIN, OXYTOCIN

PACLITAXEL, PACLITAXEL

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PANCURONIUM BROMIDE, PANCURONIUM BROMIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROPOFOL, PROPOFOL

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

TERBUTALINE SULFATE, TERBUTALINE SULFATE

THIOTEPA, THIOTEPA

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

ZANOSAR, STREPTOZOCIN

TEVA PHARMS

* TEVA PHARMACEUTICALS USA

ALENDRONATE SODIUM, ALENDRONATE SODIUM

ALPRAZOLAM, ALPRAZOLAM

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TEVA PHARMACEUTICALS USA

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

AZITHROMYCIN, AZITHROMYCIN

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFDINIR, CEFDINIR

CEFPROZIL, CEFPROZIL

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

(OTC)

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CICLOPIROX, CICLOPIROX

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

ASPARTATE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

ETHOSUXIMIDE, ETHOSUXIMIDE

FAMCICLOVIR, FAMCICLOVIR

FENTANYL-100, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-75, FENTANYL

GABAPENTIN, GABAPENTIN

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL LACTATE

HYDROCORTISONE, HYDROCORTISONE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

LEFLUNOMIDE, LEFLUNOMIDE

LEVETIRACETAM, LEVETIRACETAM

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

MEBENDAZOLE, MEBENDAZOLE

MEGESTROL ACETATE, MEGESTROL ACETATE

MELOXICAM, MELOXICAM

METHAZOLAMIDE, METHAZOLAMIDE

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

OXCARBAZEPINE, OXCARBAZEPINE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PREVIFEM, ETHINYL ESTRADIOL

PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

QUINIDINE SULFATE, QUINIDINE SULFATE

RAMIPRIL, RAMIPRIL

RISEDRONATE SODIUM, RISEDRONATE SODIUM

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TRANDOLAPRIL, TRANDOLAPRIL

TRI-PREVIFEM, ETHINYL ESTRADIOL

URSODIOL, URSODIOL

VALPROIC ACID, VALPROIC ACID

VANDAZOLE, METRONIDAZOLE

ZALEPLON, ZALEPLON

ZONISAMIDE, ZONISAMIDE

TG UNITED INC

* TG UNITED INC

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

THE PHARMA NETWORK

* THE PHARMA NETWORK LLC

BENZONATATE, BENZONATATE

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

THERAGEN

* THERAGEN INC

FLURBIPROFEN, FLURBIPROFEN

THERAKOS

* THERAKOS INC

UVADEX, METHOXSALEN

THREE RIVERS PHARMS

* THREE RIVERS PHARMACEUTICALS LLC

AMPHOTEC, AMPHOTERICIN B

RIBASPHERE, RIBAVIRIN

RIBAVIRIN, RIBAVIRIN

TIBOTEC

* TIBOTEC INC

INTELENCE, ETRAVIRINE

PREZISTA, DARUNAVIR ETHANOLATE

TOLMAR

* TOLMAR INC

ATRIDOX, DOXYCYCLINE HYCLATE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CICLOPIROX, CICLOPIROX

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

ERYTHROMYCIN AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

KETOCONAZOLE, KETOCONAZOLE

LEVETIRACETAM, LEVETIRACETAM

LIDOCAINE AND PRILOCAINE, LIDOCAINE

METRONIDAZOLE, METRONIDAZOLE

MOMETASONE FUROATE, MOMETASONE FUROATE

TOPOTARGET

* TOPOTARGET AS

TOTECT, DEXRAZOXANE HYDROCHLORIDE

TORPHARM

* TORPHARM INC

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CAPTOPRIL, CAPTOPRIL

CARBIDOPA AND LEVODOPA, CARBIDOPA

CIMETIDINE, CIMETIDINE

CIMETIDINE, CIMETIDINE (OTC)

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

CYCLOSPORINE, CYCLOSPORINE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DILT-CD, DILTIAZEM HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ETODOLAC, ETODOLAC

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

FLUCONAZOLE, FLUCONAZOLE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

GEMFIBROZIL, GEMFIBROZIL

GLIPIZIDE, GLIPIZIDE

KETOCONAZOLE, KETOCONAZOLE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NIZATIDINE, NIZATIDINE

PENTOXIFYLLINE, PENTOXIFYLLINE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RANITIDINE, RANITIDINE HYDROCHLORIDE (OTC)

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TORPHARM INC

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TORRENT PHARMS

* TORRENT PHARMACEUTICALS LTD

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

LEVETIRACETAM, LEVETIRACETAM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

TRACE LIFE

* TRACE LIFE SCIENCES INC

THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE, TL-201

TRIAX PHARMS LLC

* TRIAX PHARMACEUTICALS LLC

LOCOID LIPOCREAM, HYDROCORTISONE BUTYRATE

LOCOID, HYDROCORTISONE BUTYRATE

MINOCIN, MINOCYCLINE HYDROCHLORIDE

TRETINOIN, TRETINOIN

TRUXTON INC

* TRUXTON INC

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

TYCO HLTHCARE

* TYCO HEALTHCARE GROUP LP

ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE

PAMELOR, NORTRIPTYLINE HYDROCHLORIDE

RESTORIL, TEMAZEPAM

TOFRANIL, IMIPRAMINE HYDROCHLORIDE

TOFRANIL-PM, IMIPRAMINE PAMOATE

* TYCO HEALTHCARE MALLINCKRODT

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

TUSSICAPS, CHLORPHENIRAMINE POLISTIREX

UCB INC

* UCB INC

DIPENTUM, OLSALAZINE SODIUM

KEPPRA XR, LEVETIRACETAM

KEPPRA, LEVETIRACETAM

LORTAB, ACETAMINOPHEN

METADATE CD, METHYLPHENIDATE HYDROCHLORIDE

METADATE ER, METHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE

SEMPREX-D, ACRIVASTINE

THEO-24, THEOPHYLLINE

TUSSIONEX PENNKINETIC, CHLORPHENIRAMINE POLISTIREX

XYZAL, LEVOCETIRIZINE DIHYDROCHLORIDE

ZAROXOLYN, METOLAZONE

UCYCLYD

* UCYCLYD PHARMA INC

AMMONUL, SODIUM BENZOATE

UDL LABS

* UDL LABORATORIES

SULFAMYLON, MAFENIDE ACETATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** U **

ULURU

* ULURU INC

AMLEXANOX, AMLEXANOX

APHTHASOL, AMLEXANOX

UNICHEM

* UNICHEM LABORATORIES LTD

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

MELOXICAM, MELOXICAM

ZALEPLON, ZALEPLON

UNIMED

* UNIMED INC

MARINOL, DRONABINOL

UNIMED PHARMS

* UNIMED PHARMACEUTICALS INC

ANDROGEL, TESTOSTERONE

UNIMED PHARMS LLC

* UNIMED PHARMACEUTICALS LLC

PROMETRIUM, PROGESTERONE

UNIQUE PHARM LABS

* UNIQUE PHARMACEUTICAL LABORATORIES

ATENOLOL, ATENOLOL

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

FLUCONAZOLE, FLUCONAZOLE

UNITED GUARDIAN

* UNITED GUARDIAN INC

RENACIDIN, CITRIC ACID

UNITED THERAP

* UNITED THERAPEUTICS CORP

REMODULIN, TREPROSTINIL SODIUM

UPSHER SMITH

* UPSHER SMITH LABORATORIES INC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DIVIGEL, ESTRADIOL

FORTICAL, CALCITONIN SALMON RECOMBINANT

KLOR-CON M10, POTASSIUM CHLORIDE

KLOR-CON M15, POTASSIUM CHLORIDE

KLOR-CON M20, POTASSIUM CHLORIDE

KLOR-CON, POTASSIUM CHLORIDE

NIACOR, NIACIN

NYSTATIN, NYSTATIN

ORVATEN, MIDODRINE HYDROCHLORIDE

OXANDROLONE, OXANDROLONE

PACERONE, AMIODARONE HYDROCHLORIDE

PENTOXIL, PENTOXIFYLLINE

PREVALITE, CHOLESTYRAMINE

SORINE, SOTALOL HYDROCHLORIDE

ZALEPLON, ZALEPLON

US SURGCL

* UNITED STATES SURGICAL DIV TYCO HEALTHCARE GROUP LP

LYMPHAZURIN, ISOSULFAN BLUE

US WORLDMEDS

* US WORLDMEDS LLC

DANTROLENE SODIUM, DANTROLENE SODIUM

USL PHARMA

* USL PHARMA INC

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

BACLOFEN, BACLOFEN

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** U **

* USL PHARMA INC

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CLOFIBRATE, CLOFIBRATE

ESTRADIOL, ESTRADIOL

FLUOXYMESTERONE, FLUOXYMESTERONE

JANTOVEN, WARFARIN SODIUM

MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

VALEANT

* VALEANT PHARMACEUTICALS INTERNATIONAL

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ANCOBON, FLUCYTOSINE

BONTRIL PDM, PHENDIMETRAZINE TARTRATE

CESAMET, NABILONE

D.H.E. 45, DIHYDROERGOTAMINE MESYLATE

DIASTAT ACUDIAL, DIAZEPAM

DIASTAT, DIAZEPAM

FLUOROURACIL, FLUOROURACIL

MIGRANAL, DIHYDROERGOTAMINE MESYLATE

MYSOLINE, PRIMIDONE

PHRENILIN FORTE, ACETAMINOPHEN

PHRENILIN WITH CAFFEINE AND CODEINE, ACETAMINOPHEN

PHRENILIN, ACETAMINOPHEN

VALEANT PHARM INTL

* VALEANT PHARMACEUTICALS INTERNATIONAL

8-MOP, METHOXSALEN

ANDROID 10, METHYLTESTOSTERONE

ANDROID 25, METHYLTESTOSTERONE

DALMANE, FLURAZEPAM HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

EFUDEX, FLUOROURACIL

LEVO-DROMORAN, LEVORPHANOL TARTRATE

LIBRIUM, CHLORDIAZEPOXIDE HYDROCHLORIDE

LIMBITROL DS, AMITRIPTYLINE HYDROCHLORIDE

LIMBITROL, AMITRIPTYLINE HYDROCHLORIDE

MESTINON, PYRIDOSTIGMINE BROMIDE

OXSORALEN, METHOXSALEN

OXSORALEN-ULTRA, METHOXSALEN

TASMAR, TOLCAPONE

TENSILON PRESERVATIVE FREE, EDROPHONIUM CHLORIDE

TENSILON, EDROPHONIUM CHLORIDE

TESTRED, METHYLTESTOSTERONE

VIRAZOLE, RIBAVIRIN

ZELAPAR, SELEGILINE HYDROCHLORIDE

VALIDUS PHARMS INC

* VALIDUS PHARMACEUTICALS INC

BUMEX, BUMETANIDE

EQUETRO, CARBAMAZEPINE

MARPLAN, ISOCARBOXAZID

VATRING PHARMS

* VATRING PHARMACEUTICALS LP

UREX, METHENAMINE HIPPURATE

VERSAPHARM

* VERSAPHARM INC

RIFAMPIN, RIFAMPIN

VERUS PHARMS

* VERUS PHARMACEUTICALS INC

TWINJECT 0.15, EPINEPHRINE

TWINJECT 0.3, EPINEPHRINE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** V **
VICURON
* VICURON PHARMACEUTICALS INC
ERAXIS, ANIDULAFUNGIN
VINTAGE
* VINTAGE PHARMACEUTICALS LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACETIC ACID, ACETIC ACID, GLACIAL

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALPRAZOLAM, ALPRAZOLAM

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL

HYDROCORTISONE, HYDROCORTISONE

LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LISINOPRIL, LISINOPRIL

NYSTATIN, NYSTATIN

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PREDNISOLONE, PREDNISOLONE

PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE DM, DEXTROMETHORPHAN HYDROBROMIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE WITH CODEINE, CODEINE PHOSPHATE

RISPERIDONE, RISPERIDONE

SPIRONOLACTONE, SPIRONOLACTONE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VALPROIC ACID, VALPROIC ACID

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

VINTAGE PHARMS

* VINTAGE PHARMACEUTICALS INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ALLOPURINOL, ALLOPURINOL

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

BACLOFEN, BACLOFEN

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN

CARISOPRODOL, CARISOPRODOL

CLONAZEPAM, CLONAZEPAM

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DIAZEPAM, DIAZEPAM

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

FUROSEMIDE, FUROSEMIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

HYDROCORTISONE, HYDROCORTISONE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

LACTULOSE, LACTULOSE

LORAZEPAM, LORAZEPAM

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

METHOCARBAMOL, METHOCARBAMOL

METHYLPREDNISOLONE, METHYLPREDNISOLONE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

NYSTATIN, NYSTATIN

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** V **

* VINTAGE PHARMACEUTICALS INC

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PERPHENAZINE, PERPHENAZINE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PREDNISONE, PREDNISONE

PRIMIDONE, PRIMIDONE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, ACETAMINOPHEN

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

SULFASALAZINE, SULFASALAZINE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

VIROPHARMA

* VIROPHARMA INC

VANCOCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VISTA PHARMS

* VISTA PHARMACEUTICALS INC

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

VISTAPHARM

* VISTAPHARM INC

ALBUTEROL SULFATE, ALBUTEROL SULFATE

LACTULOSE, LACTULOSE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

NYSTATIN, NYSTATIN

PHENYTOIN, PHENYTOIN

VIVUS

* VIVUS INC

MUSE, ALPROSTADIL

WARNER CHILCOTT

* WARNER CHILCOTT BERMUDA LTD

CHOLEDYL SA, OXTRIPHYLLINE

* WARNER CHILCOTT INC

DURICEF, CEFADROXIL/CEFADROXIL HEMIHYDRATE

ERYC, ERYTHROMYCIN

ESTRACE, ESTRADIOL

ESTROSTEP FE, ETHINYL ESTRADIOL

FEMCON FE, ETHINYL ESTRADIOL

FEMHRT, ETHINYL ESTRADIOL

FEMTRACE, ESTRADIOL ACETATE

LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL

LOESTRIN 21 1/20, ETHINYL ESTRADIOL

LOESTRIN 24 FE, ETHINYL ESTRADIOL

LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL

LOESTRIN FE 1/20, ETHINYL ESTRADIOL

OVCON-35, ETHINYL ESTRADIOL

OVCON-50, ETHINYL ESTRADIOL

SARAFEM, FLUOXETINE HYDROCHLORIDE

WATSON LABS

* WATSON LABORATORIES

ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE, ACETAMINOPHEN

ALENDRONATE SODIUM, ALENDRONATE SODIUM

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

CARBOPLATIN, CARBOPLATIN

CARVEDILOL, CARVEDILOL

FOLIC ACID, FOLIC ACID

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MICROGESTIN 1.5/30, ETHINYL ESTRADIOL

MICROGESTIN 1/20, ETHINYL ESTRADIOL

MICROGESTIN FE 1.5/30, ETHINYL ESTRADIOL

MICROGESTIN FE 1/20, ETHINYL ESTRADIOL

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W **

* WATSON LABORATORIES

NORCO, ACETAMINOPHEN

OXAPROZIN, OXAPROZIN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

TESTOSTERONE, TESTOSTERONE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

* WATSON LABORATORIES INC

ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACETAZOLAMIDE, ACETAZOLAMIDE

ACETOHEXAMIDE, ACETOHEXAMIDE

ACYCLOVIR, ACYCLOVIR

AFEDITAB CR, NIFEDIPINE

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALLOPURINOL, ALLOPURINOL

ALORA, ESTRADIOL

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMOXAPINE, AMOXAPINE

ANDRODERM, TESTOSTERONE

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

ATENOLOL, ATENOLOL

BACLOFEN, BACLOFEN

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

BREVICON 28-DAY, ETHINYL ESTRADIOL

BROMPHENIRAMINE MALEATE, BROMPHENIRAMINE MALEATE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN

CAPTOPRIL, CAPTOPRIL

CARBOPLATIN, CARBOPLATIN

CARISOPRODOL, CARISOPRODOL

CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CHLORPROPAMIDE, CHLORPROPAMIDE

CHLORZOXAZONE, CHLORZOXAZONE

CICLOPIROX, CICLOPIROX

CIMETIDINE, CIMETIDINE

CIMETIDINE, CIMETIDINE (OTC)

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM

COL-PROBENECID, COLCHICINE

CORDRAN, FLURANDRENOLIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

ASPARTATE

DIAZEPAM, DIAZEPAM

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DILACOR XR, DILTIAZEM HYDROCHLORIDE

DIMENHYDRINATE, DIMENHYDRINATE

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE

DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE

DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W **

* WATSON LABORATORIES INC

DOXYCYCLINE, DOXYCYCLINE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

ERGOLOID MESYLATES, ERGOLOID MESYLATES

ESTAZOLAM, ESTAZOLAM

ESTRADIOL CYPIONATE, ESTRADIOL CYPIONATE

ESTRADIOL VALERATE, ESTRADIOL VALERATE

ESTRADIOL, ESTRADIOL

ESTRONE, ESTRONE

ESTROPIPATE, ESTROPIPATE

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

FENTANYL-100, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-75, FENTANYL

FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

FUROSEMIDE, FUROSEMIDE

GABAPENTIN, GABAPENTIN

GEMFIBROZIL, GEMFIBROZIL

GLIPIZIDE, GLIPIZIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL LACTATE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROXOCOBALAMIN, HYDROXOCOBALAMIN

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

INDAPAMIDE, INDAPAMIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

ISONIAZID, ISONIAZID

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVORA 0.15/30-28, ETHINYL ESTRADIOL

LISINOPRIL, LISINOPRIL

LORAZEPAM, LORAZEPAM

LOW-OGESTREL-21, ETHINYL ESTRADIOL

LOW-OGESTREL-28, ETHINYL ESTRADIOL

LOXAPINE SUCCINATE, LOXAPINE SUCCINATE

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM

MELOXICAM, MELOXICAM

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

MEPIVACAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE

MEPROBAMATE, MEPROBAMATE

METAPROTERENOL SULFATE, METAPROTERENOL SULFATE

METHOCARBAMOL, METHOCARBAMOL

METHYCLOTHIAZIDE, METHYCLOTHIAZIDE

METHYLDOPA, METHYLDOPA

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METHYLPREDNISOLONE, METHYLPREDNISOLONE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METRONIDAZOLE, METRONIDAZOLE

MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W **

* WATSON LABORATORIES INC

MICROZIDE, HYDROCHLOROTHIAZIDE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MINOXIDIL, MINOXIDIL

MIRTAZAPINE, MIRTAZAPINE

MORPHINE SULFATE, MORPHINE SULFATE

NALIDIXIC ACID, NALIDIXIC ACID

NAPROXEN SODIUM, NAPROXEN SODIUM

NAPROXEN, NAPROXEN

NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

NIZATIDINE, NIZATIDINE

NORCO, ACETAMINOPHEN

NORETHIN 1/35E-21, ETHINYL ESTRADIOL

NORETHIN 1/35E-28, ETHINYL ESTRADIOL

NORETHIN 1/50M-21, MESTRANOL

NORETHIN 1/50M-28, MESTRANOL

NORETHINDRONE AND ETHINYL ESTRADIOL (10/11), ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL (7/14), ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE AND MESTRANOL, MESTRANOL

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORINYL 1+35 21-DAY, ETHINYL ESTRADIOL

NORINYL 1+35 28-DAY, ETHINYL ESTRADIOL

NORINYL 1+50 21-DAY, MESTRANOL

NORINYL 1+50 28-DAY, MESTRANOL

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

OGESTREL 0.5/50-21, ETHINYL ESTRADIOL

OGESTREL 0.5/50-28, ETHINYL ESTRADIOL

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

OXAZEPAM, OXAZEPAM

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE AND ASPIRIN, ASPIRIN

OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN

PENTAMIDINE ISETHIONATE, PENTAMIDINE ISETHIONATE

PENTAZOCINE AND NALOXONE HYDROCHLORIDES, NALOXONE HYDROCHLORIDE

PENTOXIFYLLINE, PENTOXIFYLLINE

PINDOLOL, PINDOLOL

PIROXICAM, PIROXICAM

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

PREDNISOLONE, PREDNISOLONE

PREDNISONE, PREDNISONE

PRIMIDONE, PRIMIDONE

PROBENECID, PROBENECID

PROCAINE HYDROCHLORIDE, PROCAINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

QUASENSE, ETHINYL ESTRADIOL

QUINIDINE GLUCONATE, QUINIDINE GLUCONATE

QUINIDINE SULFATE, QUINIDINE SULFATE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RANITIDINE, RANITIDINE HYDROCHLORIDE (OTC)

RAPAFLO, SILODOSIN

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SULFASALAZINE, SULFASALAZINE

SULINDAC, SULINDAC

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W **

* WATSON LABORATORIES INC

TEMAZEPAM, TEMAZEPAM

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

THIOTHIXENE, THIOTHIXENE

TOLAZAMIDE, TOLAZAMIDE

TOLBUTAMIDE, TOLBUTAMIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TRELSTAR DEPOT, TRIPTORELIN PAMOATE

TRELSTAR LA, TRIPTORELIN PAMOATE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TRIAZOLAM, TRIAZOLAM

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

TRIMETHOPRIM, TRIMETHOPRIM

TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL

TRIVORA-28, ETHINYL ESTRADIOL

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

ZOVIA 1/35E-21, ETHINYL ESTRADIOL

ZOVIA 1/35E-28, ETHINYL ESTRADIOL

ZOVIA 1/50E-21, ETHINYL ESTRADIOL

ZOVIA 1/50E-28, ETHINYL ESTRADIOL

* WATSON LABS INC

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

WATSON LABS (UTAH)

* WATSON LABORATORIES INC

INFED, IRON DEXTRAN

NOR-QD, NORETHINDRONE

OXYTROL, OXYBUTYNIN

PROGESTERONE, PROGESTERONE

WATSON LABS FLORIDA

* WATSON LABORATORIES INC FLORIDA

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

CARTIA XT, DILTIAZEM HYDROCHLORIDE

CLARITHROMYCIN, CLARITHROMYCIN

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

KETOPROFEN, KETOPROFEN

LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)

LORATADINE, LORATADINE (OTC)

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

NAPROXEN SODIUM, NAPROXEN SODIUM

OMEPRAZOLE, OMEPRAZOLE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, ACETAMINOPHEN

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TAZTIA XT, DILTIAZEM HYDROCHLORIDE

WATSON PHARMS

* WATSON PHARMACEUTICALS

TENUATE DOSPAN, DIETHYLPROPION HYDROCHLORIDE

TENUATE, DIETHYLPROPION HYDROCHLORIDE

* WATSON PHARMACEUTICALS INC

ACTIGALL, URSODIOL

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W **

* WATSON PHARMACEUTICALS INC

CONDYLOX, PODOFILOX

CORDRAN SP, FLURANDRENOLIDE

CORDRAN, FLURANDRENOLIDE

FERRLECIT, SODIUM FERRIC GLUCONATE COMPLEX

FIORICET W/ CODEINE, ACETAMINOPHEN

FIORICET, ACETAMINOPHEN

FIORINAL W/CODEINE, ASPIRIN

FIORINAL, ASPIRIN

MONODOX, DOXYCYCLINE

WE PHARMS

* WE PHARMACEUTICALS INC

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PREDNISOLONE, PREDNISOLONE

WEILL MEDCL COLL

* WEILL MEDICAL COLLEGE CORNELL UNIV

FLUDEOXYGLUCOSE F 18, FLUDEOXYGLUCOSE F-18

WELLSPRING PHARM

* WELLSPRING PHARMACEUTICAL CORP

DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE

DUVOID, BETHANECHOL CHLORIDE

DYRENIUM, TRIAMTERENE

WEST WARD

* WEST WARD INC

ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

* WEST WARD PHARMACEUTICAL CORP

ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN

AMINOPHYLLINE, AMINOPHYLLINE

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE WITH CODEINE PHOSPHATE, ACETAMINOPHEN

BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN

CAPTOPRIL, CAPTOPRIL

CARISOPRODOL, CARISOPRODOL

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

CHLOROTHIAZIDE, CHLOROTHIAZIDE

CORTISONE ACETATE, CORTISONE ACETATE

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DIGOXIN, DIGOXIN

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE

FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE

FOLIC ACID, FOLIC ACID

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROCORTISONE, HYDROCORTISONE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

ISONIAZID, ISONIAZID

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LITHIUM CARBONATE, LITHIUM CARBONATE

METHOCARBAMOL, METHOCARBAMOL

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PREDNISONE, PREDNISONE

PRIMIDONE, PRIMIDONE

PROPOXYPHENE HYDROCHLORIDE, PROPOXYPHENE HYDROCHLORIDE

PROPYLTHIOURACIL, PROPYLTHIOURACIL

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

ZALEPLON, ZALEPLON

WESTWARD

* WESTWARD PHARMACEUTICAL CORP

NAPROXEN, NAPROXEN

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W **

* WESTWARD PHARMACEUTICAL CORP

RIFAMPIN AND ISONIAZID, ISONIAZID

WOCKHARDT

* WOCKHARDT AMERICAS INC

CAPTOPRIL, CAPTOPRIL

ENALAPRIL MALEATE, ENALAPRIL MALEATE

FAMOTIDINE, FAMOTIDINE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

* WOCKHARDT LTD

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AZITHROMYCIN, AZITHROMYCIN

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

CEFOTAXIME SODIUM, CEFOTAXIME SODIUM

CEFOTAXIME, CEFOTAXIME SODIUM

CEFPROZIL, CEFPROZIL

CEFTAZIDIME, CEFTAZIDIME

CEFTRIAXONE, CEFTRIAXONE SODIUM

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CLARITHROMYCIN, CLARITHROMYCIN

DIVALPROEX SODIUM, DIVALPROEX SODIUM

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

FAMOTIDINE, FAMOTIDINE (OTC)

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

FUROSEMIDE, FUROSEMIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LEVETIRACETAM, LEVETIRACETAM

LISINOPRIL, LISINOPRIL

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

NIACIN, NIACIN

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, ACETAMINOPHEN

RANITIDINE, RANITIDINE HYDROCHLORIDE (OTC)

RISPERIDONE, RISPERIDONE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

WOCKHARDT USA

* WOCKHARDT USA INC

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

WYETH CONS

* WYETH CONSUMER HEALTHCARE

ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)

ADVIL COLD AND SINUS, IBUPROFEN (OTC)

ADVIL LIQUI-GELS, IBUPROFEN (OTC)

ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN (OTC)

ADVIL PM, DIPHENHYDRAMINE CITRATE (OTC)

ADVIL PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)

ADVIL, IBUPROFEN (OTC)

ALAVERT, LORATADINE (OTC)

AXID AR, NIZATIDINE (OTC)

BRONITIN MIST, EPINEPHRINE BITARTRATE (OTC)

CHILDREN'S ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)

CHILDREN'S ADVIL COLD, IBUPROFEN (OTC)

CHILDREN'S ADVIL, IBUPROFEN (OTC)

CHILDREN'S ADVIL-FLAVORED, IBUPROFEN (OTC)

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W **

* WYETH CONSUMER HEALTHCARE

JUNIOR STRENGTH ADVIL, IBUPROFEN (OTC)

LORATADINE, LORATADINE (OTC)

PEDIATRIC ADVIL, IBUPROFEN (OTC)

PRIMATENE MIST, EPINEPHRINE (OTC)

WYETH PHARMS INC

* WYETH PHARMACEUTICALS INC

CORDARONE, AMIODARONE HYDROCHLORIDE

EFFEXOR XR, VENLAFAXINE HYDROCHLORIDE

EFFEXOR, VENLAFAXINE HYDROCHLORIDE

INDERAL LA, PROPRANOLOL HYDROCHLORIDE

LO/OVRAL-28, ETHINYL ESTRADIOL

LYBREL, ETHINYL ESTRADIOL

MYLOTARG, GEMTUZUMAB OZOGAMICIN

PHOSPHOLINE IODIDE, ECHOTHIOPHATE IODIDE

PREMARIN, ESTROGENS, CONJUGATED

PREMPHASE 14/14, ESTROGENS, CONJUGATED

PREMPRO, ESTROGENS, CONJUGATED

PRISTIQ, DESVENLAFAXINE SUCCINATE

PROTONIX IV, PANTOPRAZOLE SODIUM

PROTONIX, PANTOPRAZOLE SODIUM

RAPAMUNE, SIROLIMUS

TORISEL, TEMSIROLIMUS

TRECATOR, ETHIONAMIDE

TRIPHASIL-28, ETHINYL ESTRADIOL

TYGACIL, TIGECYCLINE

ZOSYN IN PLASTIC CONTAINER, PIPERACILLIN SODIUM

ZOSYN, PIPERACILLIN SODIUM

X GEN PHARMS

* X GEN PHARMACEUTICALS INC

ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM

AMPHOTERICIN B, AMPHOTERICIN B

BACIIM, BACITRACIN

BACI-RX, BACITRACIN

COLISTIMETHATE, COLISTIMETHATE SODIUM

HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE

HYDRO-RX, HYDROCORTISONE

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM

NEO-FRADIN, NEOMYCIN SULFATE

NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE

NEOMYCIN SULFATE, NEOMYCIN SULFATE

NEO-RX, NEOMYCIN SULFATE

NYSTATIN, NYSTATIN

POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

POLY-RX, POLYMYXIN B SULFATE

STREPTOMYCIN SULFATE, STREPTOMYCIN SULFATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

XANODYNE PHARM

* XANODYNE PHARMACEUTICS INC

AMICAR, AMINOCAPROIC ACID

DARVOCET A500, ACETAMINOPHEN

DARVOCET-N 100, ACETAMINOPHEN

DARVOCET-N 50, ACETAMINOPHEN

DARVON, PROPOXYPHENE HYDROCHLORIDE

DARVON-N, PROPOXYPHENE NAPSYLATE

DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

DURACLON, CLONIDINE HYDROCHLORIDE

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

ORAMORPH SR, MORPHINE SULFATE

XANODYNE PHARMS

* XANODYNE PHARMACEUTICALS INC

ROXICODONE, OXYCODONE HYDROCHLORIDE

 DECEMBER 2008 - APPROVED DRUG PRODUCTS LIST

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APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** X **

X-GEN PHARMS

* X-GEN PHARMACEUTICALS INC

PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE

XTTRIUM

* XTTRIUM LABORATORIES INC

DYNA-HEX, CHLORHEXIDINE GLUCONATE (OTC)

EXIDINE, CHLORHEXIDINE GLUCONATE (OTC)

YUNG SHIN PHARM

* YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD

CEFACLOR, CEFACLOR

CEPHALEXIN, CEPHALEXIN

ZAMBON

* ZAMBON CORP

MONUROL, FOSFOMYCIN TROMETHAMINE

ZARS PHARM

* ZARS PHARMA INC

SYNERA, LIDOCAINE

ZENITH GOLDLINE

* ZENITH GOLDLINE LABORATORIES INC

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

* ZENITH GOLDLINE PHARMACEUTICALS

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

ZYDUS PHARMS USA

* ZYDUS PHARMACEUTICALS USA INC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ATENOLOL, ATENOLOL

AZATHIOPRINE, AZATHIOPRINE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BENZONATATE, BENZONATATE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL

MELOXICAM, MELOXICAM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN, NAPROXEN

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RAMIPRIL, RAMIPRIL

RIBAVIRIN, RIBAVIRIN

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

WARFARIN SODIUM, WARFARIN SODIUM

ZONISAMIDE, ZONISAMIDE

ZYDUS PHARMS USA INC

* ZYDUS PHARMACEUTICALS USA INC

ACETAZOLAMIDE, ACETAZOLAMIDE

ALPRAZOLAM, ALPRAZOLAM

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE

CARVEDILOL, CARVEDILOL

DIPYRIDAMOLE, DIPYRIDAMOLE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

LAMOTRIGINE, LAMOTRIGINE

RISPERIDONE, RISPERIDONE