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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - February 2006

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
177-210PIOGLITAZONE HYDROCHLORIDE TABLETS, 15 MG (BASE), 30 MG (BASE), AND 45 MG (BASE)  TEVA PHARMACEUTICALS USA2/7/2006 
277-425ADENOSINE INJECTION USP, 3 MG/ML; 20 ML AND 30 ML VIALS  SICOR PHARMACEUTICALS, INC.2/10/2006 
375-576OMEPRAZOLE DELAYED-RELEASE CAPSULES USP, 10 MG AND 20 MG  DR. REDDY'S LABORATORIES LIMITED2/13/2006 
476-893DONEPEZIL HYDROCHLORIDE TABLETS, 5 MG AND 10 MG  PAR PHARMACEUTICAL, INC.2/13/2006 
577-481FOSPHENYTOIN SODIUM INJECTION USP, 75 MG/ML (50 MG PE/ML); 100 MG PE/2 ML AND 500 MG PE/10 ML VIALS [PE=PHENYTOIN SODIUM EQUIVALENTS]  BEDFORD LABORATORIES2/14/2006 
676-882RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS, 20 MG  TEVA PHARMACEUTICALS USA2/15/2006 
777-316CARVEDILOL TABLETS, 3.125 MG, 6.25 MG, 12.5 MG, AND 25 MG  MYLAN PHARMACEUTICALS, INC.2/22/2006 
877-106SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)  ZYDUS PHARMACEUTICALS USA, INC.2/24/2006 
976-759ONDANSETRON INJECTION USP, 2 MG/ML; 2 ML VIALS  TEVA PHARMACEUTICALS USA2/24/2006 
1076-876ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS  TEVA PHARMACEUTICALS USA2/24/2006 
1176-797RISPERIDONE ORAL SOLUTION, 1 MG/ML  PAR PHARMACEUTICAL, INC.2/24/2006 
1277-303ONDANSETRON HYDROCHLORIDE TABLETS, 4 MG (BASE), 8 MG (BASE), 16 MG (BASE), AND 24 MG (BASE)  KALI LABORATORIES, INC.2/27/2006 
1376-252ONDANSETRON HYDROCHLORIDE TABLETS, 4 MG (BASE), 8 MG (BASE), AND 24 MG (BASE)  TEVA PHARMACEUTICALS USA2/28/2006 
1476-810ONDANSETRON ORALLY DISINTEGRATING TABLETS, 4 MG AND 8 MG  TEVA PHARMACEUTICALS USA2/28/2006