Drug Approval Package

Zirgan (ganciclovir ophthalmic gel) 0.15%
Company: Sirion Therapeutics, Inc.
Application No.: 022211
Approval Date: 9/15/2009

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Cross Discipline Team Leader Review (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)
• Proprietary Name Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: January 5, 2010

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