Drug Approval Package

Fortovase/Saquinavir
Company: Hoffman-LaRoche
Application No.:  20828
Approval Date: 11/7/1997

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• Approval Letter (181 KB)
• Medical Review(s)
  • Part 1 (2.3 MB)
  • Part 2 (3.5 MB)
• Chemistry Review(s), Environmental Assessment and/or FONSI, Pharmacology Review(s) (2.5 MB)
• Statistical Review(s), Clinical Pharmacology & Biopharmaceutics Review(s), Administrative Document(s) (1.9 MB)

Date created: May 11, 1998

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