FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
Approval Letter (734 KB)
Medical Review(s)
Chemistry Review(s) (1.3 MB)
Pharmacology Review(s) Part 1 (2.3 MB) Part 2 (2 MB)
Statistical Review(s) Part 1 (2.3 MB) Part 2 (1.9 MB) Part 3 (2.6 MB) Part 4 (2.2 MB)
Clinical Pharmacology Biopharmaceutics Review(s) Part 1 (1.5 MB) Part 2 (1.9 MB) Part 3 (2.5 MB) Part 4 (2.8 MB)
Administrative Document(s)/Correspondence (2.3 MB)
Back to Drug Approval Page
PDF requires the free Adobe Acrobat Reader
Date created: March 30, 2001; last update: July 5, 2005
CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page
FDA/Center for Drug Evaluation and Research