Drug Approval Package

Tamiflu (Oseltamivir Phosphate) Capsule
Company:  Hoffman-La Roche, Inc.
Application No.:  021087
Approval Date: 10/27/1999

• Approval Letter(s) (PDF)  

• Medical Review(s) 

  Part 1 (PDF)
  Part 2 (PDF)

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s)

  Part 1 (PDF)
  Part 2 (PDF)

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Microbiology Review(s), Administrative Document(s) & Correspondence (PDF)  

Date created: March 30, 2001

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