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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - October 2003

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-048 OMEPRAZOLE DELAYED-RELEASE CAPSULES 40 MG  TORPHARM 10/6/2003 
2 75-827 GABAPENTIN TABLETS 600 MG AND 800 MG   TEVA PHARMACEUTICALS USA 10/16/2003 
3 76-311 TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG  PAR PHARMACEUTICAL, INC. 10/22/2003 
4 76-513 OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%  NOVEX PHARMA 10/22/2003 
5 76-617 FLUCONAZOLE 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 
6 76-351 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG   MYLAN PHARMACEUTICALS, INC. 10/31/2003 
7 76-413 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG   RANBAXY LABORATORIES LIMITED 10/31/2003 
8 76-496 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG   BARR LABORATORIES, INC. 10/31/2003 

 

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