Drug Approval Package

OPANA ER (oxymorphone hydrochloride) Extended-Release Tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg
Company: Endo Pharmaceuticals Inc.
Application No.: 201655
Approval Date: 12/09/2011

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

Date created: August 27, 2012

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