| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
77-132 |
RISEDRONATE SODIUM TABLETS, 5 MG, 30 MG, AND
35 MG |
TEVA PHARMACEUTICALS USA |
8/11/2005 |
| 2 |
77-297 |
GRANISETRON HYDROCHLORIDE INJECTION, 1MG/ML;
4 ML VIALS |
SICOR PHARMACEUTICALS, INC. |
8/16/2005 |
| 3 |
77-165 |
GRANISETRON HYDROCHLORIDE INJECTION, 1 MG/ML;
1 ML VIALS |
SICOR PHARMACEUTICALS, INC. |
8/16/2005 |
| 4 |
77-367 |
FAMOTIDINE TABLETS USP (OTC), 20 MG |
DR. REDDY'S LABORATORIES LIMITED |
8/17/2005 |
| 5 |
77-295 |
GLIMEPIRIDE TABLETS, 1 MG, 2 MG, AND 4 MG |
INVAGEN PHARMACEUTICALS, INC. |
8/18/2005 |
| 6 |
77-091 |
GLIMEPIRIDE TABLETS, 1 MG, 2 MG, AND 4 MG |
DR. REDDY'S LABORATORIES LIMITED |
8/18/2005 |
| 7 |
77-359 |
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG |
CARACO PHARMACEUTICAL LABORATORIES, LTD. |
8/19/2005 |
| 8 |
77-177 |
GRANISETRON HYDROCHLORIDE INJECTION, 1 MG
(BASE)/ML; 4 ML VIALS |
BAXTER HEALTHCARE CORPORATION |
8/23/2005 |
| 9 |
77-267 |
ZIDOVUDINE TABLETS USP, 300 MG |
AUROBINDO PHARMA LIMITED |
8/25/2005 |
| 10 |
76-930 |
ONDANSETRON HYDROCHLORIDE TABLETS, 4 MG, 8
MG, 16 MG, AND 24 MG |
MYLAN PHARMACEUTICALS, INC. |
8/25/2005 |
| 11 |
77-262 |
AMLODIPINE BESYLATE TABLETS, 2.5 MG, 5 MG,
AND 10 MG |
ROXANE LABORATORIES, INC. |
8/31/2005 |
