Drug Approval Package

 Vivelle
Company:  Novartis
Application No.:  021167 & 020323/23
Approval Date: 8/16/2000

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

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

Date created: March 112004

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