Drug Approval Package

Diovan
Company: Novartis Pharmaceuticals
Application No.: 020818
Approval Date: 03/06/1998

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)  

• Environmental Assessment (PDF)  

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

• Statistical Review(s) (PDF)  

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

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) 

• Administrative Document(s) & Correspondence (PDF)  

Date created: August 8, 2003

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