| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
40-416 |
WARFARIN SODIUM TABLETS, USP 1 MG, 2 MG, 2.5
MG, 3 MG 4 MG, 5 MG, 6 MG, 7.5 MG, AND 10 MG |
UPSHER-SMITH LABORATORIES, INC. |
10/2/2003 |
| 2 |
76-048 |
OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG AND
20 MG |
TORPHARM |
10/6/2003 |
| 3 |
65-151 |
CYCLOSPORINE INJECTION, USP 50 MG/ML PACKAGED
IN 250 MG/5 ML AMPOULES |
PHARMAFORCE, INC. |
10/7/2003 |
| 4 |
40-440 |
AMPHETAMINE AND DEXTROAMPHETAMINE TABLETS
(MIXED SALTS) 5 MG, 7.5 MG, 10 MG, 12.5 MG, 15 MG, 20 MG,
AND 30 MG |
MALLINCKRODT, INC. |
10/7/2003 |
| 5 |
40-512 |
PYRIDOSTIGMINE BROMIDE TABLETS, USP 60 MG
|
BARR LABORATORIES, INC. |
10/8/2003 |
| 6 |
76-401 |
VINCRISTINE SULFATE INJECTION, USP 1 MG/ML;
PACKAGED IN 5 MG/5 ML MULTIPLE-DOSE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
10/28/2003 |
| 7 |
76-281 |
TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE
AND 4 MG (BASE) |
AMIDE PHARMACEUTICAL, INC. |
10/20/2003 |
| 8 |
40-525 |
PHENTERMINE HYDROCHLORIDE CAPSULES, USP 30 MG
|
MUTUAL PHARMACEUTICAL COMPANY, INC. |
10/23/2003 |
| 9 |
40-527 |
PHENTERMINE HYDROCHLORIDE CAPSULES, USP 37.5
MG |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
10/23/2003 |
| 10 |
40-526 |
PHENTERMINE HYDROCHLORIDE TABLETS, USP 37.5
MG |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
10/23/2003 |
| 11 |
75-868 |
FENOFIBRATE CAPSULES (MICRONIZED) 67 MG, 134
MG, AND 200 MG |
IMPAX LABORATORIES, INC. |
10/27/2003 |
| 12 |
65-126 |
CEFUROXIME AXETIL TABLETS, USP 250 MG (BASE)
AND 500 MG (BASE) |
BIOCHEMIE U.S., INC. |
10/28/2003 |
| 13 |
76-545 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 500 MG |
IVAX PHARMACEUTICALS, INC. |
10/28/2003 |
| 14 |
40-520 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL
SOLUTION 7.5 MG/500 MG PER 15 ML |
VINTAGE PHARMACEUTICALS, LLC |
10/30/2003 |
| 15 |
40-462 |
NOREPINEPHRINE BITARTRATE INJECTION, USP 1 MG
(BASE)/ML, PACKAGED IN 4 MG (BASE)/4 ML VIALS |
BEDFORD LABORATORIES |
10/31/2003 |
| 16 |
75-557 |
RANITIDINE CAPSULES 150 MG AND 300 MG |
TEVA PHARMACEUTICALS USA |
10/31/2003 |
