Drug Approval Package

Integrilin (Eptifibatide) Injection
Company:  COR Therapeutics, Inc.
Application No.:  20-718
Approval Date: 5/18/1998

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence 
  Part 1 (PDF)  
  Part 2 (PDF)  

Date created: May 17, 2005

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