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U.S. Department of Health and Human Services

Drugs

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Approvals - March 2003

  ANDA Number Generic Drug Name Applicant Approval Date
1 40-455 NOREPINEPHRINE BITARTRATE INJECTION, USP 1 MG (BASE)/ML, PACKAGED IN 4 MG (BASE)/4 ML SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC. 3/3/2003 
2 40-463 ORPHENADRINE CITRATE INJECTION, USP 30MG/ML, PACKAGED IN 60 MG/2 ML VIALS BEDFORD LABORATORIES 3/4/2003 
3 40-399 PREDNISOLONE SYRUP, USP 15 MG/5 ML PHARMACEUTICAL ASSOCIATES, INC. 3/5/2003 
4 40-497 PHENTERMINE HYDROCHLORIDE CAPSULES, USP 15 MG ABLE LABORATORIES, INC. 3/13/2003 
5 76-174 ETODOLAC EXTENDED-RELEASE TABLETS 400 MG, 500 MG, AND 600 MG TARO PHARMACEUTICAL INDUSTRIES, LTD. 3/13/2003 
6 40-413 METHOCARBAMOL TABLETS, USP 500 MG AND 750 MG ABLE LABORATORIES, INC. 3/17/2003 
7 40-442 CARBINOXAMINE MALEATE TABLETS, USP 4 MG MIKART, INC. 3/19/2003 
8 65-132 AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, U 200 MG/28.5 MG (BASE)/5 ML, AND 400 MG/57 MG (BASE)/5 ML RANBAXY LABORATORIES, LTD. 3/19/2003 
9 76-367 AMCINONIDE OINTMENT, USP 0.1% TARO PHARMACEUTICAL INDUSTRIES, LTD. 3/19/2003 
10 40-515 PROMETHAZINE HYDROCHLORIDE INJECTION, USP 25 MG/ML; (1 ML AMPULES) PHARMAFORCE, INC. 3/19/2003 
11 75-736 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG AND 10 MG/25 MG IVAX PHARMACEUTICALS, INC. 3/25/2003 
12 75-183 PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG (BASE)/5 ML HI-TECH PHARMACAL CO., INC. 3/26/2003 
13 65-115 CEFADROXIL FOR ORAL SUSPENSION, USP 125 MG/5 ML, 250 MG/5 ML, AND 500 MG/5 ML RANBAXY LABORATORIES LIMITED 3/26/2003 
14 40-441 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 500 MG/30 MG ANDRX PHARMACEUTICALS, L.L.C. 3/27/2003 
15 76-421 FLECAINIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MG RANBAXY LABORATORIES LIMITED 3/28/2003 
16 40-488 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 500 MG/60 MG ANDRX PHARMACEUTICALS L.LC. 3/28/2003 
17 76-354 TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE) AND 4 MG (BASE) MYLAN PHARMACEUTICALS, INC. 3/28/2003 
18 75-823 CALCITRIOL INJECTION 0.001MG/ML AND 0.002 MG/ML PACKAGED IN 1 ML FILL IN 2ML SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC. 3/31/2003 
19 76-398 TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) AND 20 MG (BASE) EGIS PHARMACEUTICALS, LTD. 3/31/2003 
20 75-553 IPRATROPIUM BROMIDE NASAL SOLUTION, (NASAL SPRAY) 0.06% (0.042 MG/SPRAY) DEY, L.P. 3/31/2003 
21 75-552 IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL SPRAY) 0.03% (0.021 MG/SPRAY) DEY, L.P. 3/31/2003 
22 76-025 IPRATROPIUM BROMIDE NASAL SOLUTION (NASAL SPRAY) 0.03% (0.021 MG/SPRAY) BAUSCH & LOMB PHARMACEUTICALS, INC. 3/31/2003 
23 76-103 IPRATROPIUM BROMIDE NASAL SOLUTION 0.06% (NASAL SPRAY) BAUSCH & LOMB PHARMACEUTICALS, INC. 3/31/2003 
24 74-539 TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) PHARMACHEMIE B.V. 3/31/2003 

 

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