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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - July 2003

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-309NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG  DR. REDDY'S LABORATORIES LIMITED7/7/2003 
276-188FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG  GENEVA PHARMACEUTICALS TECHNOLOGY CORP.7/10/2003 
376-139FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG  TEVA PHARMACEUTICALS USA7/10/2003 
476-332FLUCONAZOLE FOR ORAL SUSPENSION 10 MG/ML AND 40 MG/ML  RANBAXY LABORATORIES LIMITED7/11/2003 
576-578ZOLPIDEM TARTRATE TABLETS 5 MG AND 10 MG  MYLAN PHARMACEUTICALS, INC.7/17/2003 
676-087FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML PACKAGED IN 200 MG /100ML 400 MG/200 ML FLEXIBLE PLASTIC CONTAINERS  BEDFORD LABORATORIES7/17/2003 
776-199PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, AND 40 MG  IVAX PHARMACEUTICALS, INC.7/31/2003