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Drug Approval Package: FIRDAPSE (amifampridine)

Company: Catalyst Pharmaceuticals, Inc.
Application Number:208078 Orig 1
Approval Date: 11/28/2018

Drugs@FDA information available about FIRDAPSE

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

Officer/Employee List (PDF)
Summary Review(s) (PDF)
Clinical Pharmacology and Biopharmaceutics (PDF)
Medical Review(s) (PDF)
Chemistry Review(s) (PDF)
Statistical Review(s) (PDF)
Non-Clinical Review(s) (PDF)
Risk Assessment and Risk Mitigation Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Other Review(s) (PDF)
Administrative Document(s) & Correspondence (PDF)

Date created: December 28, 2018

Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.

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