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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - May 2003

 ANDA NumberGeneric Drug NameApplicantTentative Approval Date
176-386FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MGRANBAXY LABORATORIES LIMITED5/2/2003 
276-424FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MGPLIVA, INC.5/9/2003 
376-250NIACIN EXTENDED-RELEASE TABLETS 1000 MGBARR LABORATORIES, INC.5/9/2003 
476-501ADENOSINE INJECTION, USP 3 MG/ML PACKAGED IN 6 MG/2 ML SINGLE-DOSE SYRINGESBAXTER HEALTHCARE CORPORATION5/14/2003 
576-500ADENOSINE INJECTION, USP 3 MG/ML PACKAGED IN 6 MG/2 ML SINGLE-DOSE VIALSBAXTER HEALTHCARE CORPORATION5/14/2003 
676-256FLUMAZENIL INJECTION 0.1 MG/ML; PACKAGED IN 0.5 MG/5 ML AND 1 MG/10 ML MULTIPLE-DOSE VIALSBEDFORD LABORATORIES5/21/2003 
776-254BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2%ALCON UNIVERSAL, INC.5/29/2003 
875-876OMEPRAZOLE DELAYED-RELEASE CAPSULES 40 MGMYLAN PHARMACEUTICALS, INC.5/29/2003 
976-109KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION 0.5%NOVEX PHARMA5/30/2003