Drug Approval Package

Actonel (Risedronate Sodium) Tablets
Company:  Procter and Gamble Pharmaceuticals
Application No.:  20-835/S1, S2, S3 & S4
Approval Date: 4/14/00

• 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)

• Clinical Pharmacology Biopharmaceutics Review(s)(PDF)  

• Administrative Document(s)(PDF)  

• Correspondence 
  Part 1(PDF)  
  Part 2(PDF)  
  Part 3(PDF)  

Date created: August 17, 2001

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