| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
75-428 |
GABAPENTIN CAPSULES 100 MG 300 MG 400 MG |
GENEVA PHARMACEUTICALS, INC. |
12/10/2003 |
| 2 |
76-276 |
LEVOFLOXACIN TABLETS 250 MG 500 MG |
MYLAN PHARMACEUTICALS INC. |
12/10/2003 |
| 3 |
76-488 |
MESNA INJECTION 100 MG/ML; PACKAGED IN 1 G/10
ML MULTIPLE-DOSE VIALS |
BIONICHE PHARMA (CANADA) LTD. |
12/17/2003 |
| 4 |
76-448 |
TOPIRAMATE CAPSULES 15 MG, AND 25 MG |
BARR LABORATORIES, INC. |
12/17/2003 |
| 5 |
76-499 |
MOMETASONE FUROATE TOPICAL SOLUTION, USP 0.1%
|
ATRIX LABORATORIES, INC. |
12/19/2003 |
| 6 |
76-377 |
TERBINAFINE HYDROCHLORIDE TABLETS 250 MG
(BASE) |
TEVA PHARMACEUTICALS USA |
12/19/2003 |
| 7 |
76-390 |
TERBINAFINE HYDROCHLORIDE TABLETS 250 MG
(BASE) |
DR. REDDY'S LABORATORIES LIMITED |
12/19/2003 |
| 8 |
76-446 |
OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 10 MG, 20 MG, AND 40 MG |
IMPAX LABORATORIES, INC. |
12/23/2003 |
| 9 |
76-652 |
POLYETHYLENE GLYCOL 3350 POWDER FOR ORAL
SOLUTION 17 G/SCOOPFUL |
SCHWARZ PHARMA, INC. |
12/23/2003 |
| 10 |
76-617 |
FLUCONAZOLE INJECTION (IN 0.9% SODIUM
CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400
MG/200 ML SINGLE-DOSE VIALS |
SICOR PHARMACEUTICALS, INC. |
12/24/2003 |
| 11 |
76-584 |
ALENDRONATE SODIUM TABLETS 5 MG (BASE), 10 MG
(BASE), 35 MG (BASE), AND 70 MG (BASE) |
MYLAN PHARMACEUTICALS, INC. |
