Drug Approval Package

Butrans (buprenorphine) Transdermal System for transdermal administration (5 mcg/hour, 10 mcg/hour, and 20 mcg/hour)
Company: Purdue Pharma L.P.
Application No.: 021306
Approval Date: 06/30/2010

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Cross Discipline Team Leader Review (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Risk Evaluation and Mitigation Strategy (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Other Action Letter(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: September 26, 2011

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