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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208078
Company: CATALYST PHARMS

Medication Guide

Products on NDA 208078

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FIRDAPSE	AMIFAMPRIDINE PHOSPHATE	EQ 10MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208078

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/28/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208078s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208078Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208078Orig1_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/30/2024	SUPPL-12	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208078s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208078Orig1s012ltr.pdf
05/15/2023	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208078s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208078Orig1s009ltr.pdf
09/29/2022	SUPPL-8	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208078s008lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208078Orig1s008ltr.pdf
03/01/2021	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208078s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208078Orig1s007ltr.pdf

Labels for NDA 208078

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/30/2024	SUPPL-12	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208078s012lbl.pdf
05/15/2023	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208078s009lbl.pdf
09/29/2022	SUPPL-8	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208078s008lbledt.pdf
03/01/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208078s007lbl.pdf
11/28/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208078s000lbl.pdf

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