Drug Information |
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 |
FDA/Center for Drug Evaluation and Research
Last Updated: January 4, 2002
Originator: OGC
HTML by PKS, TA