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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - September 2004

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-739FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG and 20 MG/12.5 MG  RANBAXY PHARMACEUTICALS, INC.9/1/2004 
276-874LEVOFLOXACIN TABLETS 250 MG, 500 MG, AND 750 MG  RANBAXY LABORATORIES LIMITED9/9/2004 
376-537GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.9/20/2004 
476-581CETIRIZINE HYDROCHLORIDE TABLETS 5 MG AND 10 MG  TEVA PHARMACEUTICALS USA9/21/2004 
576-475TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS 37.5 MG/325 MG  KALI LABORATORIES9/22/2004 
676-992CIPROFLOXACIN INJECTION, USP 10 MG/ML; PACKAGED IN 200 MG/20 ML AND 400 MG/40 ML SINGLE-DOSE VIALS  BEDFORD LABORATORIES9/23/2004 
776-872HALOBETASOL PROPIONATE OINTMENT 0.05%  AGIS INDUSTRIES (1983) LTD.9/24/2004 
876-277RIBAVIRIN CAPSULES 200 MG  TEVA PHARMACEUTICALS USA9/24/2004 
976-818METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG  COBALT PHARMACEUTICALS, INC.9/27/2004 
1076-869METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 750 MG  ANDRX PHARMACEUTICALS LLC9/29/2004