Drug Approval Package

 Enbrel (Etanercept) Vial
Company:  Immunex Corporation
Application No.:  103795S5102
Approval Date: 8/21/2003

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) (PDF)  

Date created: December 062004

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