Drug Approval Package

Asacol (mesalamine) Tablets
Company:  Procter and Gamble
Application No.:  019651/S005
Approval Date: 8/19/1997

• Approval Letter(s) (PDF)  

• Approvable Letter

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

• Environmental Assessment (PDF)  

• Pharmacology Review(s)
  

  • Part 1 (PDF)  
    
  • Part 2 (PDF)  
    
  • Part 3 (PDF)  
    
  • Part 4 (PDF)  
    
  • Part 5 (PDF)  
    
  • Part 6 (PDF)  
    
  • Part 7 (PDF)  
    

• Statistical Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)

Date created: May 22, 2003

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