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U.S. Department of Health and Human Services

Drugs

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Approvals - February 2004

  ANDA Number Generic Drug Name Applicant Approval Date
1 76-491 POLYETHYLENE GLYCOL 3350, KCL, NaHCO3 & NACL FOR ORAL SOLUT 420 G, 1.48 G, 5.72 G, AND 11.2 G, RESPECTIVELY PER BOTTLE   SCHWARZ PHARMA, INC. 2/5/2004 
2 65-088 NEOMYCIN & POLYMYXIN B SULFATES, & BACITRACIN ZN OPHTHAL OIN 3.5 MG (BASE), 10,000 UNITS, AND 400 UNITS, RESPECTIVELY, PER GRAM   AKORN, INC. 2/6/2004 
3 76-636 OXYCODONE HYDROCHLORIDE TABLETS, USP 15 MG, AND 30 MG   AMIDE PHARMACEUTICAL, INC. 2/6/2004 
4 76-118 BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG   KV PHARMACEUTICAL COMPANY 2/11/2004 
5 76-402 BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG   EON LABS, INC. 2/11/2004 
6 76-267 BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG   ANDRX PHARMACEUTICALS, LLC 2/11/2004 
7 76-333 BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG   IVAX PHARMACEUTICALS, INC. 2/11/2004 
8 76-430 BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG   MYLAN PHARMACEUTICALS, INC. 2/11/2004 
9 76-211 BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG   TEVA PHARMACEUTICALS USA 2/11/2004 
10 40-461 MERCAPTOPURINE TABLETS, USP 50 MG   PROMETHEUS LABORATORIES, INC. 2/11/2004 
11 76-476 BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG   GENPHARM, INC. 2/11/2004 
12 76-348 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG   IVAX PHARMACEUTICALS, INC. 2/11/2004 
13 76-612 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG   GENPHARM, INC. 2/11/2004 
14 65-130 CEFIXIME TABLETS, USP 400 MG   LUPIN LIMITED 2/12/2004 
15 40-528 MERCAPTOPURINE TABLETS, USP 50 MG   ROXANE LABORATORIES 2/13/2004 
16 76-345 GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS 1.25 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG   IVAX PHARMACEUTICALS, INC. 2/18/2004 
17 65-129 CEFIXIME FOR ORAL SUSPENSION, USP 100 MG/5 ML   LUPIN LIMITED 2/23/2004 
18 76-455 DESOGESTREL AND ETHINYL ESTRADIOL TABLETS 0.10 MG/0.025 MG, 0.125 MG/0.025 MG, 0.15 MG/0.025 MG; 28-DAY TRIPHASIC REGIMEN   BARR LABORATORIES, INC. 2/24/2004 
19 40-529 METHAMPHETAMINE HYDROCHLORIDE TABLETS, USP 5 MG   ABLE LABORATORIES 2/25/2004 
20 76-342 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG   ANDRX PHARMACEUTICALS, LLC 2/11/2004 
21 76-344 BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG   RANBAXY LABORATORIES LIMITED 2/11/2004 
22 76-631 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG   EON LABS, INC. 2/11/2004 
23 76-688 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG   MYLAN PHARMACEUTICALS, INC. 2/11/2004 

 

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