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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - September 2003

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-318OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 80 MG  IMPAX LABORATORIES, INC.9/4/2003 
276-467GLIPIZIDE EXTENDED-RELEASE TABLETS 10 MG  WATSON LABORATORIES, INC.9/8/2003 
376-306TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG  ROXANE LABORATORIES, INC.9/8/2003 
476-523MEFLOQUINE HYDROCHLORIDE TABLETS 250 MG  ROXANE LABORATORIES, INC.9/12/2003 
576-564ADENOSINE INJECTION, USP 3 MG/ML PACKAGED IN 6 MG/2 ML AND 12 MG/4 ML SINGLE-DOSE VIALS  SICOR PHARMACEUTICALS, INC.9/23/2003 
676-583KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION 0.5%  ALCON INC.9/24/2003 
776-089CIPROFLOXACIN TABLETS, USP 100 MG, 250 MG, 500 MG, AND 750 MG  IVAX PHARMACEUTICALS, INC.9/25/2003 
876-432FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG  GEDEON RICHTER LTD.9/25/2003 
976-285SIMVASTATIN TABLETS, USP 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG  RANBAXY LABORATORIES, LIMITED9/26/2003 
1076-343TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG  IVAX PHARMACEUTICALS, INC.9/26/2003 
1176-168OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 80 MG  TEVA PHARMACEUTICALS USA9/29/2003 
1275-716PAROXETINE HYDROCHLORIDE TABLETS 10 MG, 20 MG, 30 MG, AND 40 MG  ALPHAPHARM PTY., LTD.9/29/2003 
1376-445PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, 40 MG, AND 80 MG  RANBAXY LABORATORIES LIMITED9/30/2003 
1476-341PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, AND 40 MG  TORPHARM INC.9/30/2003 
1576-342BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG  ANDRX PHARMACEUTICALS, INC.9/30/2003