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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - April 2004

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-615 OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%   HI-TECH PHARMACAL CO., INC. 4/19/2004 
2 76-589 FLUMAZENIL INJECTION 0.1 MG/ML   SICOR PHARMACEUTICALS, INC. 4/21/2004 
3 76-633 FLUTICASONE PROPIONATE CREAM 0.05%   ATRIX LABORATORIES, INC. 4/26/2004 
4 76-361 LEVOFLOXACIN TABLETS 250 MG, 500 MG, AND 750 MG TEVA PHARMACEUTICALS USA 4/26/2004 
5 76-017 GABAPENTIN TABLETS 600 MG AND 800 MG   IVAX PHARMACEUTICALS, INC. 4/28/2004 
6 76-538 FEXOFENADINE HCL & PSEUDOEPHEDRINE HCL EXTENDED-RELEASE TABL 60 MG/120 MG   MYLAN PHARMACEUTICALS, INC. 4/30/2004 
7 76-766 FLUCONAZOLE 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 CORPORATION 4/30/2004 

 

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