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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - May 2005

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-710 LEVOFLOXACIN TABLETS, 250 MG, 500 MG, AND 750 MG   DR. REDDY'S LABORATORIES LIMITED 5/4/2005 
2 76-616 OFLOXACIN OTIC SOLUTION, 0.3%   HI-TECH PHARMACAL CO., INC. 5/10/2005 
3 77-111 BETAMETHASONE DIPROPRIONATE LOTION USP (AUGMENTED), 0.05%   ALTANA, INC. 5/11/2005 
4 76-890 LEVOFLOXACIN TABLETS, 250 MG, 500 MG, AND 750 MG   IVAX PHARMACEUTICALS, INC. 5/19/2005 
5 76-410 ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG   TEVA PHARMACEUTICALS USA 5/26/2005 
6 77-357 LAMIVUDINE TABLETS, 150 MG   RANBAXY LABORATORIES LIMITED 5/27/2005 
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