Drug Approval Package
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Trokendi XR (topiramate) Extended-Release Capsules
Company: Supernus Pharmaceuticals, Inc.
Application No.: 201635
Approval Date: 8/16/2013
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Other Action Letters (PDF)
- Printed Labeling (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: June 24, 2014
Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
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