Drug Approval Package

Durezol (Difluprednate) Ophthalmic Emulsion
Company: Sirion Therapeutics, Inc.
Application No.:  022212
Approval Date: 06/23/2008

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

Approval Letter(s) (PDF) 

• Printed Labeling (PDF) 
• Summary Review (PDF) 

• Officer/Employee List (PDF) 
  

• Office Director Memo (PDF) 
• Cross Discipline Team Leader Reviews (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) 
• Proprietary Name Review(s) (PDF) 
• Administrative Document(s) & Correspondence (PDF) 

Date created: July 25, 2008

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