Drug Approval Package

Xeloda (Capecitabine) Tablets
Company:  Roche Pharmaceuticals
Application No.:  20-896/S006 & S009
Approval Date: 4/30/01

• Approval(ble) Letter(s) (PDF)  

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

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence 
  Part 1 (PDF)  
  Part 2 (PDF)

Date created: November 20, 2001

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