Application 212839

Type: NDA
Sponsor: SK LIFE

Application Products#

Product, Drug, Ingredient table
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N212839-001	XCOPRI	CENOBAMATE	12.5MG	TABLET / ORAL	RLD, RS	2020-03-10
N212839-002	XCOPRI	CENOBAMATE	25MG	TABLET / ORAL	RLD	2020-03-10
N212839-003	XCOPRI	CENOBAMATE	50MG	TABLET / ORAL	RLD	2020-03-10
N212839-004	XCOPRI	CENOBAMATE	100MG	TABLET / ORAL	RLD	2020-03-10
N212839-005	XCOPRI	CENOBAMATE	150MG	TABLET / ORAL	RLD	2020-03-10
N212839-006	XCOPRI	CENOBAMATE	200MG	TABLET / ORAL	RLD	2020-03-10

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212839-001	7598279	2032-10-30		Drug substance	2020-03-12
N212839-001	11654133	2039-06-16	U-3610		2023-05-31
N212839-002	7598279	2032-10-30		Drug substance	2020-03-12
N212839-002	11654133	2039-06-16	U-3610		2023-05-31
N212839-003	7598279	2032-10-30		Drug substance	2020-03-12
N212839-003	11654133	2039-06-16	U-3610		2023-05-31
N212839-004	7598279	2032-10-30		Drug substance	2020-03-12
N212839-004	11654133	2039-06-16	U-3610		2023-05-31
N212839-005	7598279	2032-10-30		Drug substance	2020-03-12
N212839-005	11654133	2039-06-16	U-3610		2023-05-31
N212839-006	7598279	2032-10-30		Drug substance	2020-03-12
N212839-006	11654133	2039-06-16	U-3610		2023-05-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 6 · 234 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212839-001	XCOPRI	12.5MG	TABLET / ORAL	RLD, RS	2020-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-002	XCOPRI	25MG	TABLET / ORAL	RLD	2020-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-003	XCOPRI	50MG	TABLET / ORAL	RLD	2020-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-004	XCOPRI	100MG	TABLET / ORAL	RLD	2020-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-005	XCOPRI	150MG	TABLET / ORAL	RLD	2020-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-006	XCOPRI	200MG	TABLET / ORAL	RLD	2020-03-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212839-001	XCOPRI	12.5MG	TABLET / ORAL	RLD, RS	2020-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-002	XCOPRI	25MG	TABLET / ORAL	RLD	2020-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-003	XCOPRI	50MG	TABLET / ORAL	RLD	2020-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-004	XCOPRI	100MG	TABLET / ORAL	RLD	2020-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-005	XCOPRI	150MG	TABLET / ORAL	RLD	2020-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-006	XCOPRI	200MG	TABLET / ORAL	RLD	2020-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212839-001	XCOPRI	12.5MG	TABLET / ORAL	RLD, RS	2020-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-002	XCOPRI	25MG	TABLET / ORAL	RLD	2020-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-003	XCOPRI	50MG	TABLET / ORAL	RLD	2020-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-004	XCOPRI	100MG	TABLET / ORAL	RLD	2020-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-005	XCOPRI	150MG	TABLET / ORAL	RLD	2020-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-006	XCOPRI	200MG	TABLET / ORAL	RLD	2020-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-001	XCOPRI	12.5MG	TABLET / ORAL	RLD, RS	2020-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-002	XCOPRI	25MG	TABLET / ORAL	RLD	2020-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-003	XCOPRI	50MG	TABLET / ORAL	RLD	2020-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-004	XCOPRI	100MG	TABLET / ORAL	RLD	2020-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-005	XCOPRI	150MG	TABLET / ORAL	RLD	2020-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-006	XCOPRI	200MG	TABLET / ORAL	RLD	2020-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212839-001	XCOPRI	12.5MG	TABLET / ORAL	RLD, RS	2020-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-002	XCOPRI	25MG	TABLET / ORAL	RLD	2020-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-003	XCOPRI	50MG	TABLET / ORAL	RLD	2020-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-004	XCOPRI	100MG	TABLET / ORAL	RLD	2020-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-005	XCOPRI	150MG	TABLET / ORAL	RLD	2020-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-006	XCOPRI	200MG	TABLET / ORAL	RLD	2020-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-001	XCOPRI	12.5MG	TABLET / ORAL	RLD, RS	2020-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-002	XCOPRI	25MG	TABLET / ORAL	RLD	2020-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-003	XCOPRI	50MG	TABLET / ORAL	RLD	2020-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-004	XCOPRI	100MG	TABLET / ORAL	RLD	2020-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-005	XCOPRI	150MG	TABLET / ORAL	RLD	2020-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-006	XCOPRI	200MG	TABLET / ORAL	RLD	2020-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-001	XCOPRI	12.5MG	TABLET / ORAL	RLD, RS	2020-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-002	XCOPRI	25MG	TABLET / ORAL	RLD	2020-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-003	XCOPRI	50MG	TABLET / ORAL	RLD	2020-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-004	XCOPRI	100MG	TABLET / ORAL	RLD	2020-03-10	`b8a1b40f171c…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 378 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212839-001	7598279	2032-10-30		Drug substance	2020-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-001	11654133	2039-06-16	U-3610		2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-002	7598279	2032-10-30		Drug substance	2020-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-002	11654133	2039-06-16	U-3610		2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-003	7598279	2032-10-30		Drug substance	2020-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-003	11654133	2039-06-16	U-3610		2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-004	7598279	2032-10-30		Drug substance	2020-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-004	11654133	2039-06-16	U-3610		2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-005	7598279	2032-10-30		Drug substance	2020-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-005	11654133	2039-06-16	U-3610		2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-006	7598279	2032-10-30		Drug substance	2020-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212839-006	11654133	2039-06-16	U-3610		2023-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212839-001	7598279	2032-10-30		Drug substance	2020-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-001	11654133	2039-06-16	U-3610		2023-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-002	7598279	2032-10-30		Drug substance	2020-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-002	11654133	2039-06-16	U-3610		2023-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-003	7598279	2032-10-30		Drug substance	2020-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-003	11654133	2039-06-16	U-3610		2023-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-004	7598279	2032-10-30		Drug substance	2020-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-004	11654133	2039-06-16	U-3610		2023-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-005	7598279	2032-10-30		Drug substance	2020-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-005	11654133	2039-06-16	U-3610		2023-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-006	7598279	2032-10-30		Drug substance	2020-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212839-006	11654133	2039-06-16	U-3610		2023-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212839-001	7598279	2032-10-30		Drug substance	2020-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-001	11654133	2039-06-16	U-3610		2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-002	7598279	2032-10-30		Drug substance	2020-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-002	11654133	2039-06-16	U-3610		2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-003	7598279	2032-10-30		Drug substance	2020-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-003	11654133	2039-06-16	U-3610		2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-004	7598279	2032-10-30		Drug substance	2020-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-004	11654133	2039-06-16	U-3610		2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-005	7598279	2032-10-30		Drug substance	2020-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-005	11654133	2039-06-16	U-3610		2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-006	7598279	2032-10-30		Drug substance	2020-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212839-006	11654133	2039-06-16	U-3610		2023-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-001	7598279	2032-10-30		Drug substance	2020-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-001	11654133	2039-06-16	U-3610		2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-002	7598279	2032-10-30		Drug substance	2020-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-002	11654133	2039-06-16	U-3610		2023-05-31	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-001	NCE	2025-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-002	NCE	2025-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-003	NCE	2025-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-004	NCE	2025-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-005	NCE	2025-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212839-006	NCE	2025-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212839-001	NCE	2025-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-002	NCE	2025-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-003	NCE	2025-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-004	NCE	2025-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-005	NCE	2025-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212839-006	NCE	2025-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-001	NCE	2025-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-002	NCE	2025-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-003	NCE	2025-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-004	NCE	2025-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-005	NCE	2025-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212839-006	NCE	2025-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-001	NCE	2025-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-002	NCE	2025-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-003	NCE	2025-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-004	NCE	2025-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-005	NCE	2025-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212839-006	NCE	2025-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212839-001	NCE	2025-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212839-002	NCE	2025-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212839-003	NCE	2025-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212839-004	NCE	2025-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212839-005	NCE	2025-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212839-006	NCE	2025-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212839-001	NCE	2025-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212839-002	NCE	2025-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212839-003	NCE	2025-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212839-004	NCE	2025-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212839-005	NCE	2025-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212839-006	NCE	2025-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212839-001	NCE	2025-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212839-002	NCE	2025-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212839-003	NCE	2025-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212839-004	NCE	2025-03-10	`5bbf6a4d5a75…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xcopri	CENOBAMATE	SK Life Science, Inc.	565c2126-57ae-4e29-b443-723bbe7e2072	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212839 application number: NDA212839 ndc (product): 71699-050 ndc (product): 71699-104 ndc (product): 71699-103 ndc (product): 71699-200 ndc (product): 71699-150 ndc (product): 71699-100 ndc (product): 71699-201 ndc (product): 71699-202

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 99 matching rows.

NDC, Name, Nonproprietary name table
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 table
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