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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - June 2005

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
177-214ZOLPIDEM TARTRATE TABLETS 5 MG AND 10 MG  ROXANE LABORATORIES, INC.6/6/2005 
277-464LAMIVUDINE TABLETS 150 MG AND 300 MG  AUROBINDO PHARMA LIMITED6/15/2005 
377-444TERBINAFINE HYDROCHLORIDE TABLETS 250 MG (BASE)  RANBAXY LABORATORIES, LTD.6/16/2005 
476-506ONDANSETRON ORALLY DISINTEGRATING TABLETS 4 MG, AND 8 MG  KALI LABORATORIES, INC.6/17/2005 
577-304CAFFEINE CITRATE ORAL SOLUTION 10 MG (BASE)/ML  PHARMAFORCE, INC.6/20/2005 
677-233CAFFEINE CITRATE INJECTION 20 MG (BASE)/ML  PHARMAFORCE, INC.6/20/2005 
777-521NEVIRAPINE TABLETS 200 MG  AUROBINDO PHARMA LIMITED6/20/2005 
877-429NEVIRAPINE TABLETS 200 MG  RANBAXY LABORATORIES LIMITED6/20/2005 
977-073AMLODIPINE BESYLATE TABLETS 2.5 MG (BASE), 5 MG (BASE), AND 10 MG (BASE)  WATSON LABORATORIES, INC.6/22/2005 
1077-673EFAVIRENZ TABLETS 600 MG  AUROBINDO PHARMA LIMITED6/24/2005 
1176-802GLIMEPIRIDE TABLETS 1 MG, 2 MG, AND 4 MG  TEVA PHARMACEUTICALS USA6/27/2005 
1277-013PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, 40 MG, AND 80 MG  GENPHARM INC.6/27/2005 
1377-223TERBINAFINE HYDROCHLORIDE TABLETS 250 MG (BASE)  ROXANE LABORATORIES, INC.6/27/2005