Drug Approval Package
-
Sustiva (efavirenz), 50mg, 100mg, 200mg capsules
Company: DuPont Pharmaceuticals Company
Application No.: 20-972
Approval Date: 9/17/1998
- Approval Letter (PDF)
- Label (PDF)
- Clinical Pharmacology and Biopharmaceutics Review (PDF)
- Chemistry Review (PDF)
- Clinical Review (PDF)
- Microbiology Review (PDF)
- Pharmacological/Toxicological Review (PDF)
- Statistical Review (PDF)
Date created: March 08, 2001; Last updated: December 15, 2011
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-