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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - November 2004

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-801PIOGLITAZONE HYDROCHLORIDE TABLETS 15 MG, 30 MG, AND 45 MG  MYLAN PHARMACEUTICALS INC.11/3/2004 
276-317TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MGTEVA PHARMACEUTICALS USA11/4/2004 
376-886FOSPHENYTOIN SODIUM INJECTION, USP 50 PE/ML [PE = PHENYTOIN SODIUM EQUIVALENTS] PACKAGED IN 100 PE/2 ML AND 500 MG PE/10 ML SINGLE-DOSE VIALS.  SICOR PHARMACEUTICALS, INC.11/18/2004 
476-649CARVEDILOL TABLETS 3.125 MG, 6.25 MG, 12.5 MG, AND 25 MG  DR, REDDY'S LABORATORIES LIMITED11/24/2004 
576-703DESMOPRESSIN ACETATE NASAL SOLUTION 0.01% (NASAL SPRAY)  APOTEX INC.11/30/2004