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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - August 2003

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
175-435GABAPENTIN CAPSULES 100 MG 300 MG 400 MG  TEVA PHARMACEUTICALS USA8/7/2003 
275-808NORGESTIMATE & ETHINYL ESTRADIOL TABLETS, USP 0.180 MG/0.035 MG, 0.215 MG/0.035 MG, 0.250 MG/0.035 MG; 28-DAY CYCLE REGIMEN  BARR LABORATORIES, INC8/20/2003 
376-159GLIPIZIDE EXTENDED-RELEASE TABLETS 10 MG  ANDRX PHARMACEUTICALS, LLC8/22/2003 
476-206CALCITRIOL INJECTION 0.001 MG/ML (1 MCG/ML)  LYNE LABORATORIES, INC.8/22/2003