Drug Approval Package

Combigan (Brimonidine Tartrate/Timolol Maleate) Ophthalmic Solution
Company: Allergan, Inc.
Application No.:  021398
Approval Date: 10/30/2007

• Approval Letter(s) (PDF) 
  

• Approvable Letter (PDF) 

• Printed Labeling (PDF) 

• Summary Review (PDF) 
• Officer/Employee List (PDF) 
• Medical Review(s) (PDF) 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (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: April 22, 2008; Updated: December 2, 2008

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