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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - May 2004

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-614LEVOFLOXACIN INJECTION IN DEXTROSE 5% (PREMIX) 5 MG/ML; PACKAGED IN 250 MG (BASE)/50 ML, 500 MG (BASE)/100 ML, & 750 MG (BASE)/150 ML SINGLE-USE VIALS  BEDFORD LABORATORIES5/14/2004 
276-599LEVOFLOXACIN INJECTION 25 MG/ML; PACKAGED IN 500 MG (BASE)/20 ML & 750 MG (BASE)/30 ML SINGLE-USE VIALS  BEDFORD LABORATORIES5/14/2004 
376-713TERBINAFINE HYDROCHLORIDE TABLETS 250 MG (BASE)  ANDRX PHARMACEUTICALS, LLC5/19/2004 
476-658FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG  DR. REDDY'S LABORATORIES LIMITED5/20/2004 
576-768ALENDRONATE SODIUM TABLETS 5 MG (BASE), 10 MG (BASE), 35 MG (BASE), 40 MG (BASE) AND 70 MG (BASE)  WATSON LABORATORIES, INC.5/25/2004 
676-694QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  MYLAN PHARMACEUTICALS, INC.5/26/2004 
776-635FENOFIBRATE TABLETS 54 MG, 107 MG, AND 160 MGRANBAXY LABORATORIES LIMITED5/27/2004