Drug Approval Package

 Retisert (Fluocinolone Acetonide Intravireal Implant)
Company: Bausch & Lomb, Inc.
Application No.:  021737
Approval Date: 04/08/2005

• Approval Letter(s) (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)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: January 222007

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