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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - April 2004

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-615OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%  HI-TECH PHARMACAL CO., INC.4/19/2004 
276-589FLUMAZENIL INJECTION 0.1 MG/ML  SICOR PHARMACEUTICALS, INC.4/21/2004 
376-633FLUTICASONE PROPIONATE CREAM 0.05%  ATRIX LABORATORIES, INC.4/26/2004 
476-361LEVOFLOXACIN TABLETS 250 MG, 500 MG, AND 750 MGTEVA PHARMACEUTICALS USA4/26/2004 
576-017GABAPENTIN TABLETS 600 MG AND 800 MG  IVAX PHARMACEUTICALS, INC.4/28/2004 
676-538FEXOFENADINE HCL & PSEUDOEPHEDRINE HCL EXTENDED-RELEASE TABL 60 MG/120 MG  MYLAN PHARMACEUTICALS, INC.4/30/2004 
776-766FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML & 400 MG/200 ML INTRAVIA PLASTIC CONTAINERS  BAXTER HEALTHCARE CORPORATION4/30/2004