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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - November 2004

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-801 PIOGLITAZONE HYDROCHLORIDE TABLETS 15 MG, 30 MG, AND 45 MG   MYLAN PHARMACEUTICALS INC. 11/3/2004 
2 76-317 TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG TEVA PHARMACEUTICALS USA 11/4/2004 
3 76-886 FOSPHENYTOIN 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 
4 76-649 CARVEDILOL TABLETS 3.125 MG, 6.25 MG, 12.5 MG, AND 25 MG   DR, REDDY'S LABORATORIES LIMITED 11/24/2004 
5 76-703 DESMOPRESSIN ACETATE NASAL SOLUTION 0.01% (NASAL SPRAY)   APOTEX INC. 11/30/2004 
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