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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - July 2005

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
177-672STAVUDINE CAPSULES USP, 30 MG AND 40 MG  AUROBINDO PHARMA LIMITED7/1/2005 
277-558LAMIVUDINE AND ZIDOVUDINE TABLETS 150 MG/300 MG  AUROBINDO PHARMA LTD.7/6/2005 
376-715MODAFINIL TABLETS 100 MG AND 200 MG  CARLSBAD TERCHNOLOGY, INC.7/13/2005 
477-327ZIDOVUDINE TABLETS USP, 300 MG  RANBAXY LABORATORIES LIMITED7/13/2005 
576-914TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS 37.5 MG/325 MG  TEVA PHARMACEUTICALS USA7/18/2005 
676-447FEXOFENADINE HYDROCHLORIDE TABLETS 30 MG, 60 MG, AND 180 MG  TEVA PHARMACEUTICALS, USA7/19/2005 
776-875GLIMEPIRIDE TABLETS 1 MG, 2 MG, 4 MG, AND 8 MG  RANBAXY LABORATORIES LIMITED7/20/2005 
876-944SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)  ANDRX PHARMACEUTICALS, LLC7/21/2005 
976-844ZIDOVUDINE TABLETS USP, 300 MG  ROXANE LABORATORIES, INC.7/27/2005 
1077-366GLIMEPIRIDE TABLETS 3 MG AND 6 MG  RANBAXY LABORATORIES LIMITED7/27/2005 
1177-009ONDANSETRON ORAL SOLUTION USP, 4 MG/5 ML  TARO PHARMACEUTICAL INDUSTRIES, LTD.7/28/2005 
1276-572SUMATRIPTAN SUCCINATE TABLETS 100 MG (BASE)  RANBAXY LABORATORIES LIMITED7/29/2005 
1376-554SUMATRIPTAN SUCCINATE TABLETS 25 MG (BASE) AND 50 MG (BASE)  RANBAXY LABORATORIES LIMITED7/29/2005 
1476-933SUMATRIPTAN SUCCINATE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)  COBALT PHARMACEUTICALS, INC.7/29/2005