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Tentative Approvals - January 2006
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ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-941 |
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG, AND 500 MG |
TEVA PHARMACEUTICALS USA |
1/11/2006 |
| 2 |
76-885 |
RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS, 20 MG |
MYLAN PHARMACEUTICALS, INC. |
1/17/2006 |
| 3 |
77-186 |
GRANISETRON HYDROCHLORIDE INJECTION, 1 MG/ML; 4 ML VIALS |
BEDFORD LABORATORIES |
1/20/2006 |
| 4 |
76-934 |
SERTRALINE HYDROCHLORIDE ORAL CONCENTRATE, 20 MG/ML |
ROXANE LABORATORIES, INC. |
1/20/2006 |
| 5 |
77-187 |
GRANISETRON HYDROCHLORIDE INJECTION, 1 MG/ML; 1 ML VIALS |
BEDFORD LABORATORIES |
1/23/2006 |
| 6 |
77-082 |
PAROXETINE TABLETS USP, 10 MG, 20 MG, 30 MG, AND 40 MG |
TEVA PHARMACEUTICALS USA |
1/25/2006 |
| 7 |
77-477 |
BETAMETHASONE DIPROPIONATE LOTION USP (AUGMENTED), 0.05% (BASE) |
TARO PHARMACEUTICALS U.S.A., INC. |
1/25/2006 |
| 8 |
77-474 |
CARVEDILOL TABLETS, 3.125 MG, 6.25 MG, 12.5 MG, AND 25 MG |
WATSON LABORATORIES, INC. |
1/25/2006 |
| 9 |
77-397 |
SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) |
INVAGEN PHARMACEUTICALS, INC. |
1/26/2006 |
| 10 |
76-685 |
SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG |
COBALT PHARMACEUTICALS, INC. |
1/30/2006 |
| 11 |
77-346 |
CARVEDILOL TABLETS, 6.25 MG, 12.5 MG, AND 25 MG |
CARACO PHARMACEUTICAL LABORATORIES LTD. |
1/30/2006 |
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Date created: February 9, 2006  |
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