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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - August 2004

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
177-011ONDANSETRON INJECTION USP (PRESERVATIVE-FREE) 2 MG (BASE)/ML, PACKAGED IN 4 MG (BASE)/2 ML SINGLE-DOSE VIALS  BEDFORD LABORATORIES8/11/2004 
276-967ONDANSETRON INJECTION, USP 2 MG (BASE)/ML, PACKAGED IN 40 MG (BASE)/20 ML MULTIPLE-DOSE VIALS  BEDFORD LABORATORIES8/11/2004 
376-671SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)  MYLAN PHARMACEUTICALS INC.8/12/2004 
476-677CETIRIZINE HYDROCHLORIDE TABLETS 5 MG AND 10 MG  MYLAN PHARMACEUTICALS, INC.8/20/2004 
576-606GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG  RANBAXY LABORATORIES LIMITED8/25/2004 
676-693ONDANSETRON ORALLY DISINTEGRATING TABLETS 4 MG AND 8 MG  BARR LABORATORIES, INC.8/26/2004