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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - July 2001

 ANDA NumberDrug NameApplicantTentative Approval Date
175-416NAPROXEN SODIUM EXTENDED-RELEASE TABLETS 375 MG (BASE)ANDRX PHARMACEUTICALS, INC.7/5/01
275-794ACETAMINOPHEN, ASPIRIN, AND CAFFEINE TABLETS 250 MG/250 MG/65 MGPERRIGO COMPANY7/12/01
375-300LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MGGENEVA PHARMACEUTICALS, INC.7/18/01
475-451LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MGMYLAN PHARMACEUTICALS, INC.7/18/01
575-551LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MGTEVA PHARMACEUTICALS USA7/18/01
675-636LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MGEON LABS MANUFACTURING, INC.7/18/01
775-685CIPROFLOXACIN TABLETS, USP 250 MG, AND 500 MG (NOTE: 750 MG STRENGTH WAS PREVIOUSLY T/A'ED)MYLAN PHARMACEUTICALS, INC.7/18/01
875-935LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MGGENPHARM INC.7/18/01
975-565LORATADINE SYRUP 10 MG/10 MLNOVEX PHARMA7/30/01
1075-882FLECAINIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MGBARR LABORATORIES, INC.7/31/01