Drug Approval Package

NuvaRing (Etonogestrel/Ethinyl Estradiol Vaginal Ring)
Company:  Organon, Inc.
Application No.:  21-187
Approval Date: 10/3/01

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

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

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (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: November 08, 2001

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