Application 212839

Type: NDA
Sponsor: SK LIFE

Related Records

Company: SK LIFE

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XCOPRI	CENOBAMATE	TABLET;ORAL	12.5MG	Yes	No
002	XCOPRI	CENOBAMATE	TABLET;ORAL	25MG	Yes	No
003	XCOPRI	CENOBAMATE	TABLET;ORAL	50MG	Yes	No
004	XCOPRI	CENOBAMATE	TABLET;ORAL	100MG	Yes	No
005	XCOPRI	CENOBAMATE	TABLET;ORAL	150MG	Yes	No
006	XCOPRI	CENOBAMATE	TABLET;ORAL	200MG	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71699-050	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-050	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-050	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-050	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-050	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-050	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-050	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-050	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-050	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-050	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-100	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-100	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-100	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-100	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-100	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-100	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-100	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-100	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-100	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-100	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-102	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-102	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-102	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-102	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-102	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-102	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-102	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-102	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-102	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-103	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-103	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-103	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-103	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-103	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-103	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-103	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-103	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-103	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-103	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-104	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-104	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-104	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-104	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-104	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-104	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-104	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-150	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-150	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-150	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-150	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-150	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-150	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-150	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-150	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-150	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-150	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-200	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-200	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-200	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-200	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-200	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-200	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-200	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-200	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-200	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-200	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-201	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-201	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-201	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-201	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-201	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-201	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-201	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-201	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-201	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-202	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-202	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-202	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-202	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current
71699-202	Xcopri	cenobamate	SK Life Science, Inc.	NDA	Current

Documents

Document	Submission type	Date
83157	SUPPL	2025-08-20
83156	SUPPL	2025-08-20
83135	SUPPL	2025-08-19
78102	SUPPL	2024-04-09
78101	SUPPL	2024-04-09
78100	SUPPL	2024-04-09
78086	SUPPL	2024-04-08
78085	SUPPL	2024-04-08
77350	SUPPL	2024-01-29
77324	SUPPL	2024-01-29
71487	SUPPL	2022-06-30
71486	SUPPL	2022-06-30
71485	SUPPL	2022-06-30
71463	SUPPL	2022-06-28
71462	SUPPL	2022-06-28
68933	ORIG	2021-10-08
64496	SUPPL	2020-09-04
64495	SUPPL	2020-09-04
64468	SUPPL	2020-09-01
61220	ORIG	2019-12-10
61020	ORIG	2019-11-22
61019	ORIG	2019-11-22