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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - May 2003

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-386 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG RANBAXY LABORATORIES LIMITED 5/2/2003 
2 76-424 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG PLIVA, INC. 5/9/2003 
3 76-250 NIACIN EXTENDED-RELEASE TABLETS 1000 MG BARR LABORATORIES, INC. 5/9/2003 
4 76-501 ADENOSINE INJECTION, USP 3 MG/ML PACKAGED IN 6 MG/2 ML SINGLE-DOSE SYRINGES BAXTER HEALTHCARE CORPORATION 5/14/2003 
5 76-500 ADENOSINE INJECTION, USP 3 MG/ML PACKAGED IN 6 MG/2 ML SINGLE-DOSE VIALS BAXTER HEALTHCARE CORPORATION 5/14/2003 
6 76-256 FLUMAZENIL INJECTION 0.1 MG/ML; PACKAGED IN 0.5 MG/5 ML AND 1 MG/10 ML MULTIPLE-DOSE VIALS BEDFORD LABORATORIES 5/21/2003 
7 76-254 BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2% ALCON UNIVERSAL, INC. 5/29/2003 
8 75-876 OMEPRAZOLE DELAYED-RELEASE CAPSULES 40 MG MYLAN PHARMACEUTICALS, INC. 5/29/2003 
9 76-109 KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION 0.5% NOVEX PHARMA 5/30/2003 

 

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