Drug Approval Package

Actonel (Risedronate Sodium) Tablets
Company:  Procter and Gamble Pharmaceuticals
Application No.:  20-835
Approval Date: 3/27/1998

• Approval Letter(s) (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)  

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)

Date created: April 04, 2002

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