Drug Approval Package

 Uroxatral (alfuzosin hydrochloride) extended release tablets
Company:  Sanofi-Synthelabo Inc.
Application No.:  021287
Approval Date: 6/12/2003

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)

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

• Chemistry Review(s) (PDF)  

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

• Statistical Review(s) (PDF)

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

• Administrative Document(s) (PDF)  
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  
  Part 5 (PDF)

• Correspondence (PDF)

Date created: September 9, 2003

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