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Drug Approval Package: FINTEPLA

Company: Zogenix, Inc
Application Number: 212102
Approval Date: 06/25/2020

Drugs@FDA information available about FINTEPLA

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

FDA Approval Letter and Labeling

Approval Letter(s) (PDF)
Printed Labeling (PDF)

FDA Application Review Files

Product Quality Review(s) (PDF)
Clinical Pharmacology and Biopharmaceutics Review(s) (PDF)
Clinical Review(s) (PDF)
Non-Clinical Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Officer/Employee List (PDF)
Other Review(s) (PDF)
REMS (PDF)
REMS Program (PDF)
Risk Assessment and Risk Mitigation Review(s) (PDF)
Statistical Review(s) (PDF)
Summary Review (PDF)
Administrative and Correspondence Documents (PDF)

Date created: December 08, 2020

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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