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U.S. Department of Health and Human Services

Drugs

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Approvals - January 2002

 ANDA NumberDrug NameApplicantApproval Date
175-844OXAPROZIN TABLETS 600 MGCARACO PHARMACEUTICAL LABORATORIES, LTD.1/3/02
240-377PHENTERMINE HYDROCHLORIDE TABLETS, USP 37.5 MGVINTAGE PHARMACEUTICALS, INC.1/4/02
375-910DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS 100 MGPUREPAC PHARMACEUTICAL CO.1/7/02
476-012BUPIVACAINE HCL INJECTION, USP (PRESERVATIVE-FREE) 0.25%, 0.5%, AND 0.75% (SINGLE-DOSE VIALS)INTERNATIONAL MEDICATION SYSTEMS, LTD.1/9/02
575-912KETOCONAZOLE TABLETS, USP 200 MGTORPHARM1/10/02
640-349SULFASALAZINE TABLETS, USP 500 MGVINTAGE PHARMACEUTICALS, INC.1/11/02
775-339SULFASALAZINE DELAYED-RELEASE TABLETS, USP 500 MGVINTAGE PHARMACEUTICALS, INC.1/11/02
875-784KETOROLAC TROMETHAMINE INJECTION, USP 15 MG/ML (1 ML FILL IN 2 ML VIAL); AND 30 MG/ML (1 ML & 2 ML FILL IN 2 ML VIALSAMERICAN PHARMACEUTICAL PARTNERS, INC.1/11/02
975-762OFLOXACIN INJECTION 40 MG/ML (10 ML SINGLE-DOSE VIALS)BEDFORD LABORATORIES1/16/02
1076-137DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES 5 MG, 10 MG, AND 15 MGBARR LABORATORIES, INC.1/18/02
1140-366HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION 7.5 MG/500 MG/15 MLKV PHARMACEUTICAL COMPANY1/23/02
1275-972METFORMIN HYDROCHLORIDE TABLETS 500 MG, 625 MG, 750 MG, 850 MG, AND 1 GGOLDLINE LABORATORIES, INC.1/24/02
1375-975METFORMIN HYDROCHLORIDE TABLETS 500 MG, 625 MG, 750 MG, 850 MG, AND 1 GZENITH GOLDLINE PHARMACEUTICALS, INC.1/24/02
1475-976METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 GMYLAN PHARMACEUTICALS, INC.1/24/02
1575-979METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 GWATSON LABORATORIES, INC.1/24/02
1676-033METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 GPUREPAC PHARMACEUTICAL CO.1/24/02
1775-961METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 GANDRX PHARMACEUTICALS, INC.1/25/02
1875-965METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 GEON LABS MANUFACTURING, INC.1/25/02
1975-971METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 GBARR LABORATORIES, INC.1/25/02
2075-973METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 GGENPHARM INC.1/25/02
2175-978METFORMIN HYDROCHLORIDE TABLETS 500 MG, AND 850 MGTEVA PHARMACEUTICALS USA1/25/02
2275-985METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 GGENEVA PHARMACEUTICALS TECHNOLOGY CORP.1/25/02
2340-436DEXTROAMPHETAMINE SULFATE TABLETS, USP 5 MG AND 10 MGMALLINCKRODT INC.1/29/02
2475-452FLUOXETINE CAPSULES, USP 10 MG, 20 MG, AND 40 MGTEVA PAHRMACEUTICALS USA1/29/02
2575-465FLUOXETINE CAPSULES, USP 10 MG AND 20 MGDR. REDDY'S LABORATORIES, INC.1/29/02
2675-577FLUOXETINE CAPSULES, USP 10 MG AND 20 MGALPHAPHARM PTY LTD.1/29/02
2775-600PODOFILOX TOPICAL SOLUTIONPADDOCK LABORATORIES, INC.1/29/02
2875-658FLUOXETINE CAPSULES, USP 10 MG AND 20 MGMALLINCKRODT INC.1/29/02
2975-662FLUOXETINE CAPSULES, USP 10 MG AND 20 MGWATSON LABORATORIES, INC.1/29/02
3075-787FLUOXETINE CAPSULES, USP 10 MG 20 MGMUTUAL PHARMACEUTICAL COMPANY INC.1/29/02
3175-807FLUOXETINE CAPSULES, USP 10 MG AND 20 MGEON LABS MANUFACTURING, INC.1/29/02
3275-872FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE)TEVA PHARMACEUTICALS USA1/29/02
3375-920FLUOXETINE ORAL SOLUTION, USP 20 MG/5 MLMALLINCKRODT INC.1/29/02
3475-967METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 GCARACO PHARMACEUTICAL LABORATORIES, LTD.1/29/02
3575-969METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 GALPHAPHARM PTY LTD.1/29/02
3676-001FLUOXETINE CAPSULES, USP 10 MG AND 20 MGSIDMAK LABORATORIES, INC.1/29/02
3776-024FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE)EON LABS MANUFACTURING, INC.1/29/02
3875-207FLUOXETINE CAPSULES, USP 10 MG 20 MGMYLAN PHARMACEUTICALS, INC.1/30/02
3975-464FLUOXETINE CAPSULES, USP 10 MG AND 20 MGSIEGFRIED LTD.1/30/02
4076-006FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE)DR. REDDY'S LABORATORIES INC.1/30/02
4176-015FLUOXETINE ORAL SOLUTION, USP 20 MG (BASE)/5 MLPHARMACEUTICAL ASSOCIATES, INC.1/30/02
4276-022FLUOXETINE CAPSULES, USP 10 MG AND 20 MGCARLSBAD TECHNOLOGY, INC.1/30/02
4365-067CLINDAMYCIN PHOSPHATE TOPICAL SUSPENSION, USP 1% (BASE)ALTANA INC.1/31/02
4475-245FLUOXETINE CAPSULES, USP 10 MG AND 20 MGIVAX PHARMACEUTICALS, INC.1/31/02
4575-690FLUOXETINE ORAL SOLUTION, USP 20 MG (BASE)/5 MLALPHARMA, U.S PHARMACEUTICALS DIVISION1/31/02