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U.S. Department of Health and Human Services

Drugs

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Approvals - January 2002

  ANDA Number Drug Name Applicant Approval Date
1 75-844 OXAPROZIN TABLETS 600 MG CARACO PHARMACEUTICAL LABORATORIES, LTD. 1/3/02
2 40-377 PHENTERMINE HYDROCHLORIDE TABLETS, USP 37.5 MG VINTAGE PHARMACEUTICALS, INC. 1/4/02
3 75-910 DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS 100 MG PUREPAC PHARMACEUTICAL CO. 1/7/02
4 76-012 BUPIVACAINE HCL INJECTION, USP (PRESERVATIVE-FREE) 0.25%, 0.5%, AND 0.75% (SINGLE-DOSE VIALS) INTERNATIONAL MEDICATION SYSTEMS, LTD. 1/9/02
5 75-912 KETOCONAZOLE TABLETS, USP 200 MG TORPHARM 1/10/02
6 40-349 SULFASALAZINE TABLETS, USP 500 MG VINTAGE PHARMACEUTICALS, INC. 1/11/02
7 75-339 SULFASALAZINE DELAYED-RELEASE TABLETS, USP 500 MG VINTAGE PHARMACEUTICALS, INC. 1/11/02
8 75-784 KETOROLAC 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 VIALS AMERICAN PHARMACEUTICAL PARTNERS, INC. 1/11/02
9 75-762 OFLOXACIN INJECTION 40 MG/ML (10 ML SINGLE-DOSE VIALS) BEDFORD LABORATORIES 1/16/02
10 76-137 DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES 5 MG, 10 MG, AND 15 MG BARR LABORATORIES, INC. 1/18/02
11 40-366 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION 7.5 MG/500 MG/15 ML KV PHARMACEUTICAL COMPANY 1/23/02
12 75-972 METFORMIN HYDROCHLORIDE TABLETS 500 MG, 625 MG, 750 MG, 850 MG, AND 1 G GOLDLINE LABORATORIES, INC. 1/24/02
13 75-975 METFORMIN HYDROCHLORIDE TABLETS 500 MG, 625 MG, 750 MG, 850 MG, AND 1 G ZENITH GOLDLINE PHARMACEUTICALS, INC. 1/24/02
14 75-976 METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 G MYLAN PHARMACEUTICALS, INC. 1/24/02
15 75-979 METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 G WATSON LABORATORIES, INC. 1/24/02
16 76-033 METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 G PUREPAC PHARMACEUTICAL CO. 1/24/02
17 75-961 METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 G ANDRX PHARMACEUTICALS, INC. 1/25/02
18 75-965 METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 G EON LABS MANUFACTURING, INC. 1/25/02
19 75-971 METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 G BARR LABORATORIES, INC. 1/25/02
20 75-973 METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 G GENPHARM INC. 1/25/02
21 75-978 METFORMIN HYDROCHLORIDE TABLETS 500 MG, AND 850 MG TEVA PHARMACEUTICALS USA 1/25/02
22 75-985 METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 G GENEVA PHARMACEUTICALS TECHNOLOGY CORP. 1/25/02
23 40-436 DEXTROAMPHETAMINE SULFATE TABLETS, USP 5 MG AND 10 MG MALLINCKRODT INC. 1/29/02
24 75-452 FLUOXETINE CAPSULES, USP 10 MG, 20 MG, AND 40 MG TEVA PAHRMACEUTICALS USA 1/29/02
25 75-465 FLUOXETINE CAPSULES, USP 10 MG AND 20 MG DR. REDDY'S LABORATORIES, INC. 1/29/02
26 75-577 FLUOXETINE CAPSULES, USP 10 MG AND 20 MG ALPHAPHARM PTY LTD. 1/29/02
27 75-600 PODOFILOX TOPICAL SOLUTION PADDOCK LABORATORIES, INC. 1/29/02
28 75-658 FLUOXETINE CAPSULES, USP 10 MG AND 20 MG MALLINCKRODT INC. 1/29/02
29 75-662 FLUOXETINE CAPSULES, USP 10 MG AND 20 MG WATSON LABORATORIES, INC. 1/29/02
30 75-787 FLUOXETINE CAPSULES, USP 10 MG 20 MG MUTUAL PHARMACEUTICAL COMPANY INC. 1/29/02
31 75-807 FLUOXETINE CAPSULES, USP 10 MG AND 20 MG EON LABS MANUFACTURING, INC. 1/29/02
32 75-872 FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) TEVA PHARMACEUTICALS USA 1/29/02
33 75-920 FLUOXETINE ORAL SOLUTION, USP 20 MG/5 ML MALLINCKRODT INC. 1/29/02
34 75-967 METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 G CARACO PHARMACEUTICAL LABORATORIES, LTD. 1/29/02
35 75-969 METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1 G ALPHAPHARM PTY LTD. 1/29/02
36 76-001 FLUOXETINE CAPSULES, USP 10 MG AND 20 MG SIDMAK LABORATORIES, INC. 1/29/02
37 76-024 FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) EON LABS MANUFACTURING, INC. 1/29/02
38 75-207 FLUOXETINE CAPSULES, USP 10 MG 20 MG MYLAN PHARMACEUTICALS, INC. 1/30/02
39 75-464 FLUOXETINE CAPSULES, USP 10 MG AND 20 MG SIEGFRIED LTD. 1/30/02
40 76-006 FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) DR. REDDY'S LABORATORIES INC. 1/30/02
41 76-015 FLUOXETINE ORAL SOLUTION, USP 20 MG (BASE)/5 ML PHARMACEUTICAL ASSOCIATES, INC. 1/30/02
42 76-022 FLUOXETINE CAPSULES, USP 10 MG AND 20 MG CARLSBAD TECHNOLOGY, INC. 1/30/02
43 65-067 CLINDAMYCIN PHOSPHATE TOPICAL SUSPENSION, USP 1% (BASE) ALTANA INC. 1/31/02
44 75-245 FLUOXETINE CAPSULES, USP 10 MG AND 20 MG IVAX PHARMACEUTICALS, INC. 1/31/02
45 75-690 FLUOXETINE ORAL SOLUTION, USP 20 MG (BASE)/5 ML ALPHARMA, U.S PHARMACEUTICALS DIVISION 1/31/02

 

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