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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - May 2005

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-710LEVOFLOXACIN TABLETS, 250 MG, 500 MG, AND 750 MG  DR. REDDY'S LABORATORIES LIMITED5/4/2005 
276-616OFLOXACIN OTIC SOLUTION, 0.3%  HI-TECH PHARMACAL CO., INC.5/10/2005 
377-111BETAMETHASONE DIPROPRIONATE LOTION USP (AUGMENTED), 0.05%  ALTANA, INC.5/11/2005 
476-890LEVOFLOXACIN TABLETS, 250 MG, 500 MG, AND 750 MG  IVAX PHARMACEUTICALS, INC.5/19/2005 
576-410ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG  TEVA PHARMACEUTICALS USA5/26/2005 
677-357LAMIVUDINE TABLETS, 150 MG  RANBAXY LABORATORIES LIMITED5/27/2005