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U.S. Department of Health and Human Services

Drugs

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Approvals - September 2001

  ANDA Number Drug Name Applicant Approval Date
1 65-026 TOBRAMYCIN OPHTHALMIC SOLUTION 0.3% ALTANA INC. 9/11/01
2 75-558 VECURONIUM BROMIDE FOR INJECTION 4 MG/AMPUL ABBOTT LABORATORIES 9/11/01
3 75-209 LORATADINE TABLETS 10 MG GENEVA PHARMACEUTICALS, INC. 9/13/01
4 75-650 FAMOTIDINE TABLETS, USP 20 MG, AND 40 MG PUREPAC PHARMACEUTICAL CO. 9/14/01
5 65-047 CEFAZOLIN FOR INJECTION, USP 500 MG/VIAL, 1 G/VIAL, AND 1 G/100 ML INFUSION VIAL. HIKMA FARMACEUTICA (PORTUGAL), LDA. 9/18/01
6 75-298 FLUTAMIDE CAPSULES USP 125 MG TEVA PHARMACEUTICALS USA 9/18/01
7 75-624 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG; AND 10 MG/25 MG MYLAN PHARMACEUTICALS, INC. 9/18/01
8 75-727 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS 5 MG/ 12.5 MG; AND 10 MG/ 25 MG TEVA PHARMACEUTICALS USA 9/18/01
9 75-788 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS USP 5 MG/ 12.5 MG; AND 10 MG/ 25 MG TARO PHARMACEUTICAL INDUSTRIES LTD 9/18/01
10 75-818 FLUTAMIDE CAPSULES USP 125 MG EON LABS MANUFACTURING, INC. 9/18/01
11 75-820 FLUTAMIDE CAPSULES USP 125 MG BARR LABORATORIES, INC. 9/18/01
12 75-635 ETOPOSIDE CAPSULES, USP 50 MG GENPHARM INC. 9/19/01
13 75-780 FLUTAMIDE CAPSULES, USP 125 MG ZENITH GOLDLINE PHARMACEUTICALS, INC. 9/19/01
14 76-116 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG, AND 10 MG/25 MG EON LABS MANUFACTURING, INC. 9/19/01
15 75-698 THIOTEPA FOR INJECTION, USP 15 MG/VIAL AAI PHARMA 9/20/01
16 75-562 IPRATROPIUM BROMIDE INHALATION SOLUTION 0.02% (0.5 MG/2.5 ML VIAL) NEPHRON PHARMACEUTICALS CORPORATION 9/27/01
17 76-121 LITHIUM CARBONATE CAPSULES, USP 300 MG ABLE LABORATORIES, INC. 9/27/01

 

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