Drug Approval Package
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Qsymia (phentermine and topiramate extended-release) Capsules CIV
Company: Vivus, Inc.
Application No.: 22580Orig1s000
Approval Date: 07/17/2012
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Summary Review (PDF)
- Officer/Employee List (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)
- 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: April 8, 2013
Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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