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U.S. Department of Health and Human Services

Drugs

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Approvals - December 2002

    

 ANDA NumberGeneric Drug NameApplicantApproval Date
165-116BACITRACIN FOR INJECTION, USP 50,000 UNITS/VIALAMERICAN PHARMACEUTICAL PARTNERS, INC.12/3/02
276-004TABLETS, USP 400 MG AND 500 MGTORPHARM12/3/02
365-119AMOXICILLIN FOR ORAL SUSPENSION, USP 200 MG/5 ML AND 400 MG/5 MLTEVA PHARMACEUTICALS USA12/4/02
475-499BUTORPHANOL TARTRATE NASAL SPRAY 10 MG/ML; 2.5 ML METERED-DOSE SPRAY PUMPNOVEX PHARMA12/4/02
565-098AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, U 200 MG/28.5 MG (BASE)/5 ML, AND 400 MG/57 MG (BASE)/5 MLLEK PHARMACEUTICALS, D.D.12/16/02
676-186AMANTADINE HYDROCHLORIDE TABLETS 100 MGUPSHER-SMITH LABORATORIES, INC.12/16/02
776-328METFORMIN HYDROCHLORIDE TABLETS 500 MG 850 MG 1000 MGTEVA PHARMACEUTICALS USA12/16/02
865-111KANAMYCIN INJECTION, USP 500 MG/2 ML VIAL, AND 1 G/3 ML VIALAMERICAN PHARMACEUTICAL PARTNERS, INC.12/17/02
975-853DILTIAZEM HYDROCHLORIDE FOR INJECTION 100 MG ADD-VANTAGE VIALSABBOTT LABORATORIES12/17/02
1075-638KETOCONAZOLE CREAM 2%TARO PHARMACEUTICALS USA, INC.12/18/02
1175-808NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS 0.180 MG/0.035 MG; 0.215 MG/0.035 MG; 0.250 MG/0.035 MG PACKAGED IN A 28-DAY REGIMENBARR LABORATORIES, INC.12/18/02
1276-263DIFLORASONE DIACETATE CREAM, USP (EMOLLIENT) 0.05%ALTANA INC.12/20/02
1376-296VINCRISTINE SULFATE INJECTION, USP (PRESERVATIVE-FREE) 1 MG/ML AND 2 MG/2ML SINGLE-DOSE VIALSAMERICAN PHARMACEUTICAL PARTNERS, INC.12/20/02
1475-181PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG (BASE)/5 MLWE PHARMACEUTICALS, INC.12/23/02
1575-791OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG AND 20 MGEON LABS, INC.12/23/02
1676-123PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG (BASE)/5 MLPHARMACEUTICAL ASSOCIATES, INC.12/23/02
1776-041ISOTRETINOIN CAPSULES, USP 10 MG, 20 MG, AND 40 MGRANBAXY LABORATORIES LIMITED12/24/02
1840-457PYRIDOSTIGMINE BROMIDE TABLETS, USP 60 MGCOREPHARMA LLC12/26/02
1975-836CALCITRIOL INJECTION 0.001 MG/ML, AND 0.002 MG/MLAMERICAN PHARMACEUTICAL PARTNERS, INC.12/31/02