Drug Approval Package

Nuvigil (armodafinil) Tablets 50 mg, 100 mg, and 250 mg.
Company: Cephalon, Inc.
NDA: 021875
Approval Date: 6/15/2007

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• Approvable Letter(s) (PDF)
  
  
• Approval Letter(s) (PDF)
  
  
• Printed Labeling (PDF)
  
  
• Medical Review(s)
  
  • Part 1 
  • Part 2 
  • Part 3  
    
    
• Chemistry Review(s) (PDF)
  
  
• Pharmacology Review(s) (PDF)  
  
  
• Statistical Review(s) (PDF)
  
  
• Clinical Pharmacology Biopharmaceutics Review(s)
  
  • Part 1 
  • Part 2  
    
    
• Proprietary Name Review(s) (PDF)
  

• Administrative Document(s) and Correspondence (PDF)

Date created: July 18, 2008

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