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U.S. Department of Health and Human Services

Drugs

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Approvals - March 2003

 ANDA NumberGeneric Drug NameApplicantApproval Date
140-455NOREPINEPHRINE BITARTRATE INJECTION, USP 1 MG (BASE)/ML, PACKAGED IN 4 MG (BASE)/4 ML SINGLE-DOSE VIALSGENSIA SICOR PHARMACEUTICALS, INC.3/3/2003 
240-463ORPHENADRINE CITRATE INJECTION, USP 30MG/ML, PACKAGED IN 60 MG/2 ML VIALSBEDFORD LABORATORIES3/4/2003 
340-399PREDNISOLONE SYRUP, USP 15 MG/5 MLPHARMACEUTICAL ASSOCIATES, INC.3/5/2003 
440-497PHENTERMINE HYDROCHLORIDE CAPSULES, USP 15 MGABLE LABORATORIES, INC.3/13/2003 
576-174ETODOLAC EXTENDED-RELEASE TABLETS 400 MG, 500 MG, AND 600 MGTARO PHARMACEUTICAL INDUSTRIES, LTD.3/13/2003 
640-413METHOCARBAMOL TABLETS, USP 500 MG AND 750 MGABLE LABORATORIES, INC.3/17/2003 
740-442CARBINOXAMINE MALEATE TABLETS, USP 4 MGMIKART, INC.3/19/2003 
865-132AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, U 200 MG/28.5 MG (BASE)/5 ML, AND 400 MG/57 MG (BASE)/5 MLRANBAXY LABORATORIES, LTD.3/19/2003 
976-367AMCINONIDE OINTMENT, USP 0.1%TARO PHARMACEUTICAL INDUSTRIES, LTD.3/19/2003 
1040-515PROMETHAZINE HYDROCHLORIDE INJECTION, USP 25 MG/ML; (1 ML AMPULES)PHARMAFORCE, INC.3/19/2003 
1175-736ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG AND 10 MG/25 MGIVAX PHARMACEUTICALS, INC.3/25/2003 
1275-183PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG (BASE)/5 MLHI-TECH PHARMACAL CO., INC.3/26/2003 
1365-115CEFADROXIL FOR ORAL SUSPENSION, USP 125 MG/5 ML, 250 MG/5 ML, AND 500 MG/5 MLRANBAXY LABORATORIES LIMITED3/26/2003 
1440-441ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 500 MG/30 MGANDRX PHARMACEUTICALS, L.L.C.3/27/2003 
1576-421FLECAINIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MGRANBAXY LABORATORIES LIMITED3/28/2003 
1640-488ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 500 MG/60 MGANDRX PHARMACEUTICALS L.LC.3/28/2003 
1776-354TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE) AND 4 MG (BASE)MYLAN PHARMACEUTICALS, INC.3/28/2003 
1875-823CALCITRIOL INJECTION 0.001MG/ML AND 0.002 MG/ML PACKAGED IN 1 ML FILL IN 2ML SINGLE-DOSE VIALSGENSIA SICOR PHARMACEUTICALS, INC.3/31/2003 
1976-398TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) AND 20 MG (BASE)EGIS PHARMACEUTICALS, LTD.3/31/2003 
2075-553IPRATROPIUM BROMIDE NASAL SOLUTION, (NASAL SPRAY) 0.06% (0.042 MG/SPRAY)DEY, L.P.3/31/2003 
2175-552IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL SPRAY) 0.03% (0.021 MG/SPRAY)DEY, L.P.3/31/2003 
2276-025IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL SPRAY) 0.03% (0.021 MG/SPRAY)BAUSCH & LOMB PHARMACEUTICALS, INC.3/31/2003 
2376-103IPRATROPIUM BROMIDE NASAL SOLUTION 0.06% (NASAL SPRAY)BAUSCH & LOMB PHARMACEUTICALS, INC.3/31/2003 
2474-539TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE)PHARMACHEMIE B.V.3/31/2003