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U.S. Department of Health and Human Services

Drugs

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Approvals - May 2003

 ANDA NumberGeneric Drug NameApplicantApproval Date
175-681MEGESTROL ACETATE ORAL SUSPENSION, USP 40 MG/MLCOPLEY PHARMACEUTICAL, INC.5/5/2003 
276-353DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES 5 MG, 10 MG, AND 15 MGMALLINCKRODT INC.5/6/2003 
340-456AMPHETAMINE AND DEXTROAMPHETAMINE TABLETS (MIXED SALTS) 5 MG, 10 MG, 20 MG, AND 30 MGWATSON LABORATORIES, INC.5/6/2003 
476-204MOEXIPRIL HYDROCHLORIDE TABLETS 7.5 MG AND 15 MGTEVA PHARMACEUTICALS USA5/8/2003 
576-224FLUTAMIDE CAPSULES, USP 125 MGGENPHARM INC.5/9/2003 
675-276BETAMETHASONE DIPROPIONATE GEL 0.05% (BASE)ALTANA INC.5/13/2003 
776-065AMCINONIDE CREAM, USP 0.1%ALTANA INC.5/15/2003 
840-490HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/500 MGABLE LABORATORIES, INC.5/21/2003 
976-226TORSEMIDE TABLETS 5 MG, 10 MG, 20 MG, AND 100 MGPAR PHARMACEUTICAL, INC.5/27/2003 
1040-494HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/750 MGANDRX PHARMACEUTICALS, LLC5/28/2003 
1140-495HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 10 MG/660 MGANDRX PHARMACEUTICALS, LLC5/28/2003 
1276-260BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2%BAUSCH & LOMB PHARMACEUTICALS, INC.5/28/2003 
1340-493HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 5 MG/500 MGANDRX PHARMACEUTICALS, LLC5/28/2003 
1475-876OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MGMYLAN PHARMACEUTICALS, INC.5/29/2003 
1575-504QUINAPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MGTEVA PHARMACEUTICALS USA5/30/2003 
1640-405PROCHLORPERAZINE EDISYLATE INJECTION, USP 5 MG (BASE)/ML PACKAGED IN 10 MG (BASE)'2 ML VIALS AND 50 MG (BASE)/10 ML MULTIPLE DOSE VIALSGENSIA SICOR PHARMACEUTICALS, INC.5/30/2003 
1776-381NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP 1.5 MG/0.03 MG (21-DAY CYCLE)BARR LABORATORIES, INC.5/30/2003 
1876-380NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP 1 MG/0.02 MG (21-DAY CYCLE)BARR LABORATORIES, INC.5/30/2003 
1976-346TORSEMIDE TABLETS 5 MG, 10 MG, AND 20 MGPLIVA PHARMACEUTICAL INDUSTRY, INC.5/30/2003