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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - January 2004

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-315TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG  BARR LABORATORIES, INC.1/5/2004 
276-335NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS 0.180MG/0.035 MG, 0.215 MG/0.035 MG, 0.25 MG/0.035 MG PACKAGED AS A TRIPHASIC REGIMEN (28-DAY CYCLE)  ANDRX PHARMACEUTICALS, LLC1/6/2004 
376-597MODAFINIL TABLETS 100 MG, AND 200 MG  BARR LABORATORIES, INC.1/7/2004 
475-815LORATADINE SYRUP 5 MG/5 ML  MORTON GROVE PHARMACEUTICALS, INC.1/16/2004 
576-430BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG  MYLAN PHARMACEUTICALS, INC.1/23/2004 
676-622OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%  BAUSCH & LOMB, INC.1/23/2004 
775-913BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS 150 MG (TWICE-A-DAY DOSING)  IMPAX LABORATORIES, INC.1/28/2004 
876-754CIPROFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%  BAUSCH & LOMB, INC.1/30/2004