Drug Approval Package: FIRDAPSE (amifampridine)
Company: Catalyst Pharmaceuticals, Inc.
Application Number:208078 Orig 1
Approval Date: 11/28/2018
Application Number:208078 Orig 1
Approval Date: 11/28/2018
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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
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