Drug Approval Package

 Kineret (Anakinra)
Company:  Amgen Inc.
Application No.:  103950
Approval Date: 11/14/2001

• Approval Letter(s) (PDF)    

• Printed Labeling (PDF)    

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)    

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)    

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)    

• Administrative Document(s) (PDF)

Date created: April 22, 2005

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