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U.S. Department of Health and Human Services

Drugs

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Approvals - September 2001

 ANDA NumberDrug NameApplicantApproval Date
165-026TOBRAMYCIN OPHTHALMIC SOLUTION 0.3%ALTANA INC.9/11/01
275-558VECURONIUM BROMIDE FOR INJECTION 4 MG/AMPULABBOTT LABORATORIES9/11/01
375-209LORATADINE TABLETS 10 MGGENEVA PHARMACEUTICALS, INC.9/13/01
475-650FAMOTIDINE TABLETS, USP 20 MG, AND 40 MGPUREPAC PHARMACEUTICAL CO.9/14/01
565-047CEFAZOLIN FOR INJECTION, USP 500 MG/VIAL, 1 G/VIAL, AND 1 G/100 ML INFUSION VIAL.HIKMA FARMACEUTICA (PORTUGAL), LDA.9/18/01
675-298FLUTAMIDE CAPSULES USP 125 MGTEVA PHARMACEUTICALS USA9/18/01
775-624ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG; AND 10 MG/25 MGMYLAN PHARMACEUTICALS, INC.9/18/01
875-727ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS 5 MG/ 12.5 MG; AND 10 MG/ 25 MGTEVA PHARMACEUTICALS USA9/18/01
975-788ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS USP 5 MG/ 12.5 MG; AND 10 MG/ 25 MGTARO PHARMACEUTICAL INDUSTRIES LTD9/18/01
1075-818FLUTAMIDE CAPSULES USP 125 MGEON LABS MANUFACTURING, INC.9/18/01
1175-820FLUTAMIDE CAPSULES USP 125 MGBARR LABORATORIES, INC.9/18/01
1275-635ETOPOSIDE CAPSULES, USP 50 MGGENPHARM INC.9/19/01
1375-780FLUTAMIDE CAPSULES, USP 125 MGZENITH GOLDLINE PHARMACEUTICALS, INC.9/19/01
1476-116ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG, AND 10 MG/25 MGEON LABS MANUFACTURING, INC.9/19/01
1575-698THIOTEPA FOR INJECTION, USP 15 MG/VIALAAI PHARMA9/20/01
1675-562IPRATROPIUM BROMIDE INHALATION SOLUTION 0.02% (0.5 MG/2.5 ML VIAL)NEPHRON PHARMACEUTICALS CORPORATION9/27/01
1776-121LITHIUM CARBONATE CAPSULES, USP 300 MGABLE LABORATORIES, INC.9/27/01