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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - January 2006

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-941DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG, AND 500 MG  TEVA PHARMACEUTICALS USA1/11/2006 
276-885RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS, 20 MG  MYLAN PHARMACEUTICALS, INC.1/17/2006 
377-186GRANISETRON HYDROCHLORIDE INJECTION, 1 MG/ML; 4 ML VIALS  BEDFORD LABORATORIES1/20/2006 
476-934SERTRALINE HYDROCHLORIDE ORAL CONCENTRATE, 20 MG/ML  ROXANE LABORATORIES, INC.1/20/2006 
577-187GRANISETRON HYDROCHLORIDE INJECTION, 1 MG/ML; 1 ML VIALS  BEDFORD LABORATORIES1/23/2006 
677-082PAROXETINE TABLETS USP, 10 MG, 20 MG, 30 MG, AND 40 MG  TEVA PHARMACEUTICALS USA1/25/2006 
777-477BETAMETHASONE DIPROPIONATE LOTION USP (AUGMENTED), 0.05% (BASE)  TARO PHARMACEUTICALS U.S.A., INC.1/25/2006 
877-474CARVEDILOL TABLETS, 3.125 MG, 6.25 MG, 12.5 MG, AND 25 MG  WATSON LABORATORIES, INC.1/25/2006 
977-397SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)  INVAGEN PHARMACEUTICALS, INC.1/26/2006 
1076-685SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG  COBALT PHARMACEUTICALS, INC.1/30/2006 
1177-346CARVEDILOL TABLETS, 6.25 MG, 12.5 MG, AND 25 MG  CARACO PHARMACEUTICAL LABORATORIES LTD.1/30/2006