Drug Approval Package

Zelnorm (Tegaserod Maleate) Tablets
Company:  Novartis Pharmaceuticals Corporation
Application No.:  21-200
Approval Date: 7/24/2002

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  

• Chemistry Review(s) (PDF)  

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

• Statistical Review(s) (PDF)  

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

• Administrative Document(s) 
  Part 1 (PDF)  
  Part 2 (PDF)  

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

Date created: October 23, 2002

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