Drug Approval Package
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Anzemet Tablets (Dolasetron mesylate)
Company: Hoescht Marion Roussel, Inc.
Application No.: 20623
Approval Date: 9/11/1997
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter (791 KB)
- Medical Review(s)
- Chemistry Review(s) & EA(Fonsi) (4.9 MB)
- Pharmacology Review(s)
- Statistical Review(s)
- Clinical Pharmacology Biopharmaceutics Review(s)
- Administrative Documents
- Correspondence (180 KB)
Date created: September 11, 1997
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