Drug Approval Package

Bextra (Valdecoxib) Tablets
Company:  G.D. Searle & Co.
Application No.:  21-341
Approval Date: 11/16/01

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) 
  Part 1 (PDF)   
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  
  Part 5 (PDF)  
  Part 6 (PDF)  

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

• Clinical Pharmacology Biopharmaceutics Review(s) 
  Part 1 (PDF)  
  Part 2 (PDF)   

• Administrative Document(s) (PDF)  

• Correspondence (PDF)

Date created: May 30, 2002

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