Approvable Letter(s) Part 1 (PDF) Part 2 (PDF)
Medical Review(s) (PDF)
Chemistry Review(s) (PDF)
Environmental Assessment (PDF)
Pharmacology Review(s) (PDF)
Statistical Review(s) (PDF)
Microbiology Review(s) (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Administrative Document(s) & Correspondence (PDF)
Date created: September 132005
Back to Top Drugs@FDA
Note: Documents in PDF format require the Adobe Acrobat Reader®.