Drug Approval Package

 Taxotere (Docetaxel) Injection
Company:  Aventis Pharmaceuticals
Application No.:  020449s028
Approval Date: 5/19/2004

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) (PDF)  

Date created: April 152005

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.