FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
Approval Letter (385 KB)
Final Printed Labeling Part 1 (1.6 MB) Part 2 (1.8 MB)
Medical Review(s)
Chemistry Review(s) (904 KB)
Environmental Assessment Part 1 (2.3 MB) Part 2 (2.7 MB) Part 3 (2.4 MB)
Pharmacology Review(s)
Statistical Review(s) Part 1 (1.7 MB) Part 2 (2.7 MB) Part 3 (2.2 MB) Part 4 (2.5 MB)
Clinical Pharmacology Biopharmaceutics Review(s)
Administrative Document(s)/Correspondence
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