Drug Approval Package

Anzemet Tablets (Dolasetron mesylate)
Company:  Hoescht Marion Roussel, Inc.
Application No.:  20624
Approval Date: 10/11/1997

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• Approval Letter (602 KB)
• Medical Review(s)
  • Part 1 (3.6 MB)
  • Part 2 (3.7 MB)
  • Part 3 (4.5 MB)
  • Part 4 (4.2 MB)
  • Part 5 (4.4 MB)
• Chemistry Review(s) & EA(Fonsi) Pharmacology Review(s) (3.7 MB)
• Statistical Review(s) & Microbiology Reviews (5.1 MB)
• Clinical Pharmacology Biopharmaceutics Review(s)
  • Part 1 (3.5 MB)
  • Part 2 (4.1 MB)
• Administrative Documents &  Correspondence (3.3 MB)

Date created: October 11, 1997

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