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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - January 2006

  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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