Drug Approval Package

 Byetta (Exenatide) Injection
Company:  Amylin Pharmaceuticals, Inc.
Application No.:  021773
Approval Date: 4/28/2005

• 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: August 042005

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