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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - May 2006

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
177-101LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, 0.15 MG/0.03 MGWATSON LABORATORIES, INC.5/8/2006
277-242GABAPENTIN CAPSULES, 100 MG, 300 MG, AND 400 MGSUN PHARMACEUTICAL INDUSTRIES LTD.5/12/2006
377-525GABAPENTIN TABLETS, 600 MG AND 800 MGSUN PHARMACEUTICAL INDUSTRIES LTD.5/12/2006
477-844ABACAVIR SULFATE TABLETS, 300 MG (BASE)AUROBINDO PHARMA LIMITED5/17/2006
577-173ONDANSETRON INJECTION USP (PRESERVATIVE-FREE), 2 MG/ML; 2 ML VIALSSUN PHARMACEUTICAL INDUSTRIES LTD.5/19/2006
677-956NEVIRAPINE TABLETS, 200 MGCIPLA LIMITED5/19/2006
777-172ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALSSUN PHARMACEUTICAL INDUSTRIES LTD.5/19/2006
876-780ONDANSETRON INJECTION USP (PRESERVATIVE-FREE), 2 MG/ML; 2 ML VIALSHIKMA FARMACEUTICA (PORTUGAL), LDA5/22/2006
976-781ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALSHIKMA FARMACEUTICA (PORTUGAL), LDA5/22/2006
1077-744SUMATRIPTAN SUCCINATE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)MYLAN PHARMACEUTICALS, INC.5/23/2006
1177-540ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MGSYNTHON PHARMACEUTICALS, INC.5/24/2006
1276-958LOSARTAN POTASSIUM TABLETS, 25 MG, 50 MG, AND 100 MGTEVA PHARMACEUTICALS, USA5/24/2006
1377-916EFAVIRENZ TABLETS, 600 MGCIPLA LIMITED5/24/2006
1477-459LOSARTAN POTASSIUM TABLETS, 25 MG, 50 MG, AND 100 MGROXANE LABORATORIES, INC.5/25/2006
1576-052SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MGIVAX PHARMACEUTICALS, INC.5/25/2006
1677-904PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, 40 MG, AND 80 MGWATSON LABORATORIES, INC.5/30/2006
1776-981ESCITALOPRAM OXALATE TABLETS, 5 MG, 10 MG, AND 20 MGALPHAPHARM PTY. LTD.5/31/2006