Drug Approval Package

Abreva (Docosanol) Cream
Company:  Avanir Pharmaceuticals
Application No.:  20-941
Approval Date: 7/25/2000

• 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)  

• Microbiology Review(s)(PDF)  

• Administrative Document(s)(PDF)  

• Correspondence(PDF)  

Date created: August 21, 2001; Updated October 7, 2008

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