Drug Approval Package

Taxotere (Docetaxel) Injection
Company:  Aventis Pharmaceuticals, Inc.
Application No.:  20-449/S18
Approval Date: 11/27/2002

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) 
  Part 1 (PDF)  
  Part 2 (PDF)  

• Chemistry Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence (PDF)

Date created: July 08, 2003

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