| 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 |