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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - July 2004

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-706METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG  APOTEX INC.7/1/2004 
276-236FEXOFENADINE HCL & PSEUDOEPHEDRINE HCL EXTENDED-RELEASE TABL 60 MG/120 MG  BARR LABORATORIES, INC.7/1/2004 
376-591MOMETASONE FUROATE CREAM, USP 0.1%  ATRIX LABORATORIES, INC.7/13/2004 
476-540SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)  GENPHARM INC.7/14/2004 
576-651QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  MUTUAL PHARMACEUTICAL COMPANY, INC.7/15/2004 
676-665FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG  APOTEX INC.7/20/2004 
776-573ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML; PACKAGED IN 100 MG/10 ML SINGLE-DOSE VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.7/20/2004 
876-871MITOXANTRONE INJECTION, USP (CONCENTRATE) 2 MG/ML; PACKAGED IN 20 MG/10 ML, 25 MG/12.5 ML, AND 30 MG/15 ML MULTIPLE-DOSE VIALS  MAYNE PHARMA (USA) INC.7/23/2004 
976-731GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS 1.25 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG  COREPHARMA LLC7/30/2004