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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - June 2003

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-039CARBOPLATIN INJECTION 10 MG/ML  BEDFORD LABORATORIES6/6/2003 
276-086FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MGGENEVA PHARMACEUTICALS, INC.6/10/2003 
375-763NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG  IVAX PHARMACEUTICALS, INC.6/11/2003 
440-486METAXALONE TABLETS 400 MG  COREPHARMA LLC6/11/2003 
576-049QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  ANDRX PHARMACEUTICALS, LLC6/11/2003 
676-378NIACIN EXTENDED-RELEASE TABLETS 500 MG, AND 750 MGBARR LABORATORIES, INC.6/13/2003 
776-220OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG  RANBAXY LABORATORIES LIMITED6/17/2003 
876-304FLUCONAZOLE INJECTION (IN 5% DEXTROSE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML FLEXIBLE PLASTIC CONTAINERS  ABBOTT LABORATORIES6/18/2003 
976-303FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML FLEXIBLE PLASTIC CONTAINERS  ABBOTT LABORATORIES6/18/2003 
1076-456ESMOLOL HYDROCHLORIDE CONCENTRATE 250 MG/ML, PACKAGED IN 2500 MG/10 ML AMPULES FOR DILUTION  PHARMAFORCE, INC.6/26/2003 
1176-474ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML, PACKAGED IN 100 MG/10 ML SINGLE-DOSE VIALS  PHARMAFORCE, INC.6/26/2003 
1276-397PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, AND 40 MGLEK PHARMACEUTICALS D.D.6/26/2003 
1376-326ESMOLOL HYDROCHLORIDE CONCENTRATE 250 MG/ML, PACKAGED IN 2,500 MG/10 ML VIALS FOR DILUTION  BEDFORD LABORATORIES6/26/2003 
1476-323ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML, PACKAGED IN 100 MG/10 ML SINGLE-DOSE VIALS  BEDFORD LABORATORIES6/26/2003