Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212839
Company: SK LIFE

• Medication Guide

Products on NDA 212839

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XCOPRI	CENOBAMATE	12.5MG	TABLET;ORAL	Prescription	None	Yes	Yes
XCOPRI	CENOBAMATE	25MG	TABLET;ORAL	Prescription	None	Yes	No
XCOPRI	CENOBAMATE	50MG	TABLET;ORAL	Prescription	None	Yes	No
XCOPRI	CENOBAMATE	100MG	TABLET;ORAL	Prescription	None	Yes	No
XCOPRI	CENOBAMATE	150MG	TABLET;ORAL	Prescription	None	Yes	No
XCOPRI	CENOBAMATE	200MG	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212839

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
11/21/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Federal Register Notice Label (PDF) Letter (PDF) Review	FR Notice on DEA Scheduling; Date of Approval – March 10, 2020

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
04/05/2024	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)
04/05/2024	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)
01/26/2024	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)
06/27/2022	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)
06/27/2022	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)
08/31/2020	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)

Labels for NDA 212839

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
04/05/2024	SUPPL-10	Labeling-Package Insert	Label (PDF)
04/05/2024	SUPPL-9	Labeling-Package Insert	Label (PDF)
01/26/2024	SUPPL-8	Labeling-Package Insert	Label (PDF)
06/27/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)
06/27/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)
08/31/2020	SUPPL-1	Labeling-Medication Guide	Label (PDF)
08/31/2020	SUPPL-1	Labeling-Package Insert	Label (PDF)
08/31/2020	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)
11/21/2019	ORIG-1	Approval	Label (PDF)