FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
Approval Letter(s) & Final Printed Labeling (2.5 MB)
Medical Review(s) Part 1 (2.5 MB) Part 2 (2.8 MB) Part 3 (2.6 MB) Part 4 (2.7 MB)
Chemistry Review(s) (453 KB)
Pharmacology Review(s) Part 1 (3 MB) Part 2 (3 MB)
Statistical Review(s) & Microbiology Review(s) (793 KB)
Clinical Pharmacology Biopharmaceutics Review(s) (2.2 MB)
Administrative Document(s)/Correspondence (3 MB)
Back to Top Back to Drugs@FDA
PDF requires the free Adobe Acrobat Reader
Date created: March 30, 2001
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
(2.5 MB)
PDF requires the free
