Drug Approval Package

Entereg (Alvinopan) Capsules
Company: Adolor Corporation
Application No.:  021775
Approval Date: 05/20/2008

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• Approval Letter(s) (PDF)

• Approvable Letter (PDF)
• Printed Labeling (PDF)
• Summary Review (PDF)
  
• Officer/Employee List (PDF)
  
• Office Director Memo (PDF)
  
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Reviews (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: July 18, 2008

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