[Skip navigation]FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Drug Evaluation and Research
  HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER

horizonal rule
CDER Home About CDER Drug Information Regulatory Guidance CDER Calendar Specific Audiences CDER Archives
 
Powered by Google
 

 First-Time Generics - February 2004

  Generic Drug Name Generic Manufacturer Brand Name Approval Date
1 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. NULYTELY FOR ORAL SOLUTION 2/5/2004
2 OXYCODONE HYDROCHLORIDE TABLETS, USP 15 MG, AND 30 MG AMIDE PHARMACEUTICAL, INC. ROXICODONE TABLETS 2/6/2004
3 BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG RANBAXY LABORATORIES LIMITED LOTENSIN TABLETS 2/11/2004
4 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 LOTENSIN HCT TABLETS 2/11/2004
5 MERCAPTOPURINE TABLETS, USP 50 MG PROMETHEUS LABORATORIES, INC. PURINETHOL TABLETS 2/11/2004
6 CEFIXIME TABLETS, USP 400 MG LUPIN LIMITED SUPRAX TABLETS 2/12/2004
7 GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS 1.25 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG IVAX PHARMACEUTICALS, INC. GLUCOVANCE TABLETS 2/18/2004
8 CEFIXIME FOR ORAL SUSPENSION, USP 100 MG/5 ML LUPIN LIMITED SUPREX FOR ORAL SUSPENSION 2/23/2004
9 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. CYCLESSA TABLETS 2/24/2004
10 METHAMPHETAMINE HYDROCHLORIDE TABLETS, USP 5 MG ABLE LABORATORIES DESOXYN TABLETS 2/25/2004

Back to Top     Back to Approvals

Date created: 3/4/2004; updated 3/24/2003

horizonal rule