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U.S. Department of Health and Human Services

Drugs

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Approvals - March 2004

  ANDA Number Generic Drug Name Applicant Approval Date
1 76-833 METOLAZONE TABLETS, USP 5 MG   TEVA PHARMACEUTICALS USA 3/1/2004 
2 75-006 CHLORHEXIDINE GLUCONATE ORAL RINSE, USP 0.12%   MORTON GROVE PHARMACEUTICALS, INC. 3/3/2004 
3 75-989 LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABL 10 MG/240 MG (24-HOUR FORMULATION) (OTC)   IMPAX LABORATORIES, INC. 3/4/2004 
4 75-716 PAROXETINE HYDROCHLORIDE TABLETS 10 MG (BASE), 20 MG (BASE), 30 MG (BASE), AND 40 MG (BASE)   ALPHAPHARM PTY. LTD. 3/8/2004 
5 75-566 PAROXETINE HYDROCHLORIDE TABLETS 10 MG (BASE), 20 MG (BASE), 30 MG (BASE) AND 40 MG (BASE)   SANDOZ INC. 3/8/2004 
6 40-521 PHENYTOIN ORAL SUSPENSION, USP 125 MG/5 ML   TARO PHARMACEUTICAL INDUSTRIES LTD. 3/8/2004 
7 76-168 OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 80 MG   TEVA PHARMACEUTICALS USA 3/23/2004 
8 65-162 AMOXICILLIN & CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, US 600 MG/42.9 MG (BASE)/5 ML   TEVA PHARMACEUTICALS USA 3/12/2004 
9 40-503 HYDROCORTISONE CREAM, USP 2.5%   VINTAGE PHARMACEUTICALS, LLC 3/12/2004 
10 76-518 NAPROXEN SODIUM & PSEUDOEPHEDRINE HCL EXTENDED-RELEASE TABLE 200 MG (BASE)/120 MG   L. PERRIGO COMPANY 3/17/2004 
11 76-019 DEFEROXAMINE MESYLATE FOR INJECTION, USP 500 MG/VIAL AND 2 G/VIAL   ABBOTT LABORATORIES 3/17/2004 
12 40-524 PROMETHAZINE HYDROCHLORIDE INJECTION, USP 25 MG/ML AND 50 MG/ML PACKAGED IN 1 ML AMPULES   BEDFORD LABORATORIES 3/17/2004 
13 76-561 DICLOFENAC POTASSIUM TABLETS 50 MG   TORPHARM, INC. 3/18/2004 
14 76-642 HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS 5 MG/200 MG   INTERPHARM, INC. 3/18/2004 
15 75-923 OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 10 MG, 20 MG, AND 40 MG   ENDO PHARMACEUTICALS, INC. 3/23/2004 
16 65-177 COLISTIMETHATE FOR INJECTION, USP 150 MG (BASE)/VIAL   PADDOCK LABORATORIES, INC. 3/19/2004 
17 65-194 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 150 MG (BASE), AND 300 MG (BASE)   COREPHARMA LLC 3/22/2004 
18 76-648 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULES 100 MG   MYLAN PHARMACEUTICALS, INC. 3/22/2004 
19 65-094 DEMECLOCYCLINE HYDROCHLORIDE TABLETS, USP 150 MG AND 300 MG   IMPAX LABORATORIES, INC. 3/22/2004 
20 75-414 NIFEDIPINE EXTENDED-RELEASE TABLETS, USP 90 MG   MARTEC SCIENTIFIC, INC. 3/23/2004 
21 76-335 NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS 0.18 MG/0.035 MG, 0.215 MG/0.035 MG, AND 0.25 MG/0.035 MG PACKAGED AS A TRIPHASIC REGIMEN (28-DAY CYCLE)   ANDRX PHARMACEUTICALS, LLC 3/26/2004 
22 76-796 FUROSEMIDE TABLETS, USP 20 MG, 40 MG, AND 80 MG   VINTAGE PHARMACEUTICALS, LLC 3/26/2004 
23 76-585 MICONAZOLE NITRATE SUPPOSITORIES & MICONAZOLE NITRATE CREAM 100 MG/2% (COMBINATION PACKAGE) (OTC)   G & W LABORATORIES, INC. 3/26/2004 
24 65-112 ERYTHROMYCIN AND BENZOYL PEROXIDE TOPICAL GEL, USP 3%/5%   ATRIX LABORATORIES, INC. 3/29/2004 
25 76-357 MICONAZOLE NITRATE CREAM 4% & MICONAZOLE NITRATE CREAM 2% 4%/2% (COMBINATION PACKAGE) (OTC)   L. PERRIGO COMPANY 3/30/2004 
26 76-374 QUINAPRIL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE TABLETS 10 MG (BASE)/12.5 MG, 20 MG (BASE)/12.5 MG, AND 20 MG (BASE)/25 MG   AMIDE PHARMACEUTICAL, INC. 3/31/2004 
27 65-184 CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION, USP 1% (BASE)   TARO PHARMACEUTICAL INDUSTRIES LTD. 3/31/2004 

 

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