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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - October 2003

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-048OMEPRAZOLE DELAYED-RELEASE CAPSULES 40 MG TORPHARM10/6/2003 
275-827GABAPENTIN TABLETS 600 MG AND 800 MG  TEVA PHARMACEUTICALS USA10/16/2003 
376-311TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG PAR PHARMACEUTICAL, INC.10/22/2003 
476-513OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% NOVEX PHARMA10/22/2003 
576-617FLUCONAZOLE INJECTION IN 0.9% SODIUM CHLORIDE INJECTION 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE PLASTIC CONTAINERS  FAULDING PHARMACEUTICAL CO.10/30/2003 
676-351FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG  MYLAN PHARMACEUTICALS, INC.10/31/2003 
776-413METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG  RANBAXY LABORATORIES LIMITED10/31/2003 
876-496METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG  BARR LABORATORIES, INC.10/31/2003