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U.S. Department of Health and Human Services

Drugs

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Approvals - April 2003

  ANDA Number Generic Drug Name Applicant Approval Date
1 76-391 ALBUTEROL SULFATE INHALATION SOLUTION 0.5% (BASE) NOVEX PHARMA 4/1/2003 
2 76-371 TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE) AND 4 MG (BASE) BARR LABORATORIES, INC. 4/9/2003 
3 75-883 AMMONIUM LACTATE CREAM 12% (BASE) TARO PHARMACEUTICALS U.S.A., INC. 4/10/2003 
4 75-401 DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP 120 MG, 180 MG, 240 MG, 300 MG, AND 360 MG (ONCE-A-DAY DOSAGE) ANDRX PHARMACEUTICALS, L.L.P. 4/10/2003 
5 76-023 HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS 7.5 MG/200 MG TEVA PHARMACEUTICALS USA 4/11/2003 
6 40-504 PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP 12.5 MG, AND 25 MG ABLE LABORATORIES, INC. 4/11/2003 
7 76-356 ISOTRETINOIN CAPSULES, USP 10 MG BARR LABORATORIES, INC. 4/11/2003 
8 76-135 ISOTRETINOIN CAPSULES, USP 20 MG AND 40 MG BARR LABORATORIES, INC. 4/11/2003 
9 40-491 DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP EQ. TO 10 MG DEXAMETHASONE PHOSPHATE/ML (PRESERVATIVE-FREE) AMERICAN PHARMACEUTICAL PARTNERS, INC. 4/11/2003 
10 65-131 MINOCYCLINE HYDROCHLORIDE TABLETS, USP 50 MG (BASE), 75 MG (BASE), AND 100 MG (BASE) PAR PHARMACEUTICAL, INC. 4/16/2003 
11 76-156 IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL SPRAY) 0.03% (0.021 MG/SPRAY) NOVEX PHARMA 4/18/2003 
12 76-155 IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL SPRAY) 0.06% (0.042 MG/SPRAY) NOVEX PHARMA 4/18/2003 
13 76-369 PERMETHRIN CREAM 5% CLAY-PARK LABS, INC. 4/21/2003 
14 40-467 TRIAMCINOLONE ACETONIDE LOTION, USP 0.025% AND 0.1% ALTANA, INC. 4/21/2003 
15 76-382 LITHIUM CARBONATE EXTENDED-RELEASE TABLETS, USP 300 MG ABLE LABORATORIES, INC. 4/21/2003 
16 40-502 PYRIDOSTIGMINE BROMIDE TABLETS, USP 60 MG IMPAX LABORATORIES, INC. 4/24/2003 
17 65-118 CEFUROXIME AXETIL TABLETS, USP 125 MG (BASE), 250 MG (BASE), AND 500 MG (BASE) RANBAXY LABORATORIES LIMITED 4/25/2003 
18 40-458 CARBINOXAMINE MALEATE ORAL SOLUTION 4 MG/5 ML MIKART, INC. 4/25/2003 
19 76-394 AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML; PACKAGED IN 150 MG/3 ML SINGLE-USE VIALS APOTEX CORP. 4/25/2003 
20 76-444 HYDROMORPHONE HYDROCHLORIDE INJECTION, USP 10 MG/ML; PACKAGED IN 10 MG/1 ML, 50 MG/5 ML, AND 500 MG/50 ML SINGLE-USE VIALS FAULDING PHARMACEUTICAL COMPANY 4/25/2003 
21 74-504 TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) AND 20 MG (BASE) TEVA PHARMACEUTICALS, USA 4/28/2003 
22 40-475 DIHYDROERGOTAMINE MESYLATE INJECTION, USP 1 MG/ML; SINGLE-DOSE AMPULES PADDOCK LABORATORIES, INC. 4/28/2003 
23 75-862 LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.1 MG AND 0.02 MG, RESPECTIVELY, (21- AND 28-DAY REGIMENS) BARR LABORATORIES, INC. 4/29/2003 

 

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