Drug Approval Package
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Avapro/Irbesartan and Irbesartan and Hydrochlorothiazide
Company: Sanofi Pharmaceuticals
Application No.: 20757/20758
Approval Date: 9/30/1997
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter (210 KB)
- Medical Review
- Chemistry Review(s) & EA(Fonsi) (4.1 MB)
- Pharmacology Review(s)
- Part 1 (4.5 MB)
- Part 2 (5.1 MB)
- Part 3 (3.9 MB)
- Part 4 (2 MB)
- Statistical Review(s) & Administrative Documents (914 KB)
Date created: May 19, 1998
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