Drug Approval Package

Oxtellar XR (oxcarbazepine) extended-release tablets 150mg, 300mg, and 600mg
Company: Supernus Pharmaceuticals, Inc.
Application No.: 202810
Approval Date: 10/19/2012

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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)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Statistical Review (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: November 29, 2012

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