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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - November 2003

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-355ALBUTEROL SULFATE INHALATION SOLUTION, USP 0.042% (BASE) PACKAGED IN 1.5 MG (BASE)/3 ML UNIT-DOSE VIALSNEPHRON PHARMACEUTICALS CORPORATION11/7/2003 
276-118BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG  KV PHARMACEUTICAL COMPANY11/7/2003 
376-211BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG  TEVA PHARMACEUTICALS USA11/7/2003 
476-507FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG  TARO PHARMACEUTICAL INDUSTRIES, LTD.11/12/2003 
575-477GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG  IVAX PHARMACEUTICALS, INC.11/24/2003