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Approvals - May 2003

  ANDA Number Generic Drug Name Applicant Approval Date
1 75-681 MEGESTROL ACETATE ORAL SUSPENSION, USP 40 MG/ML COPLEY PHARMACEUTICAL, INC. 5/5/2003 
2 76-353 DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES 5 MG, 10 MG, AND 15 MG MALLINCKRODT INC. 5/6/2003 
3 40-456 AMPHETAMINE AND DEXTROAMPHETAMINE TABLETS (MIXED SALTS) 5 MG, 10 MG, 20 MG, AND 30 MG WATSON LABORATORIES, INC. 5/6/2003 
4 76-204 MOEXIPRIL HYDROCHLORIDE TABLETS 7.5 MG AND 15 MG TEVA PHARMACEUTICALS USA 5/8/2003 
5 76-224 FLUTAMIDE CAPSULES, USP 125 MG GENPHARM INC. 5/9/2003 
6 75-276 BETAMETHASONE DIPROPIONATE GEL 0.05% (BASE) ALTANA INC. 5/13/2003 
7 76-065 AMCINONIDE CREAM, USP 0.1% ALTANA INC. 5/15/2003 
8 40-490 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/500 MG ABLE LABORATORIES, INC. 5/21/2003 
9 76-226 TORSEMIDE TABLETS 5 MG, 10 MG, 20 MG, AND 100 MG PAR PHARMACEUTICAL, INC. 5/27/2003 
10 40-494 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/750 MG ANDRX PHARMACEUTICALS, LLC 5/28/2003 
11 40-495 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 10 MG/660 MG ANDRX PHARMACEUTICALS, LLC 5/28/2003 
12 76-260 BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2% BAUSCH & LOMB PHARMACEUTICALS, INC. 5/28/2003 
13 40-493 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 5 MG/500 MG ANDRX PHARMACEUTICALS, LLC 5/28/2003 
14 75-876 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MG MYLAN PHARMACEUTICALS, INC. 5/29/2003 
15 75-504 QUINAPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG TEVA PHARMACEUTICALS USA 5/30/2003 
16 40-405 PROCHLORPERAZINE EDISYLATE INJECTION, USP 5 MG (BASE)/ML PACKAGED IN 10 MG (BASE)'2 ML VIALS AND 50 MG (BASE)/10 ML MULTIPLE DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC. 5/30/2003 
17 76-381 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP 1.5 MG/0.03 MG (21-DAY CYCLE) BARR LABORATORIES, INC. 5/30/2003 
18 76-380 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP 1 MG/0.02 MG (21-DAY CYCLE) BARR LABORATORIES, INC. 5/30/2003 
19 76-346 TORSEMIDE TABLETS 5 MG, 10 MG, AND 20 MG PLIVA PHARMACEUTICAL INDUSTRY, INC. 5/30/2003 

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FDA/Center for Drug Evaluation and Research
Last Updated: June 4, 2003
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