Application 022253

Type: NDA
Sponsor: UCB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIMPAT	LACOSAMIDE	TABLET;ORAL	50MG	Yes	No
002	VIMPAT	LACOSAMIDE	TABLET;ORAL	100MG	Yes	No
003	VIMPAT	LACOSAMIDE	TABLET;ORAL	150MG	Yes	No
004	VIMPAT	LACOSAMIDE	TABLET;ORAL	200MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022253-001	VIMPAT	LACOSAMIDE	50MG	TABLET / ORAL	AB	RLD	2008-10-28
N022253-002	VIMPAT	LACOSAMIDE	100MG	TABLET / ORAL	AB	RLD	2008-10-28
N022253-003	VIMPAT	LACOSAMIDE	150MG	TABLET / ORAL	AB	RLD	2008-10-28
N022253-004	VIMPAT	LACOSAMIDE	200MG	TABLET / ORAL	AB	RLD, RS	2008-10-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022253-001	AB
N022253-002	AB
N022253-003	AB
N022253-004	AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022253-001	D-188	2026-04-28
N022253-002	D-188	2026-04-28
N022253-003	D-188	2026-04-28
N022253-004	D-188	2026-04-28

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022253-001	VIMPAT	50MG	TABLET / ORAL	AB	RLD	2008-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022253-002	VIMPAT	100MG	TABLET / ORAL	AB	RLD	2008-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022253-003	VIMPAT	150MG	TABLET / ORAL	AB	RLD	2008-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022253-004	VIMPAT	200MG	TABLET / ORAL	AB	RLD, RS	2008-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022253-001	VIMPAT	50MG	TABLET / ORAL	AB	RLD	2008-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022253-002	VIMPAT	100MG	TABLET / ORAL	AB	RLD	2008-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022253-003	VIMPAT	150MG	TABLET / ORAL	AB	RLD	2008-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022253-004	VIMPAT	200MG	TABLET / ORAL	AB	RLD, RS	2008-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022253-001	VIMPAT	50MG	TABLET / ORAL	AB	RLD	2008-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022253-002	VIMPAT	100MG	TABLET / ORAL	AB	RLD	2008-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022253-003	VIMPAT	150MG	TABLET / ORAL	AB	RLD	2008-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022253-004	VIMPAT	200MG	TABLET / ORAL	AB	RLD, RS	2008-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022253-001	VIMPAT	50MG	TABLET / ORAL	AB	RLD	2008-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022253-002	VIMPAT	100MG	TABLET / ORAL	AB	RLD	2008-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022253-003	VIMPAT	150MG	TABLET / ORAL	AB	RLD	2008-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022253-004	VIMPAT	200MG	TABLET / ORAL	AB	RLD, RS	2008-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022253-001	VIMPAT	50MG	TABLET / ORAL	AB	RLD	2008-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022253-002	VIMPAT	100MG	TABLET / ORAL	AB	RLD	2008-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022253-003	VIMPAT	150MG	TABLET / ORAL	AB	RLD	2008-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022253-004	VIMPAT	200MG	TABLET / ORAL	AB	RLD, RS	2008-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022253-001	VIMPAT	50MG	TABLET / ORAL	AB	RLD	2008-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022253-002	VIMPAT	100MG	TABLET / ORAL	AB	RLD	2008-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022253-003	VIMPAT	150MG	TABLET / ORAL	AB	RLD	2008-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022253-004	VIMPAT	200MG	TABLET / ORAL	AB	RLD, RS	2008-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022253-001	VIMPAT	50MG	TABLET / ORAL	AB	RLD	2008-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022253-002	VIMPAT	100MG	TABLET / ORAL	AB	RLD	2008-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022253-003	VIMPAT	150MG	TABLET / ORAL	AB	RLD	2008-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022253-004	VIMPAT	200MG	TABLET / ORAL	AB	RLD, RS	2008-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022253-001	VIMPAT	50MG	TABLET / ORAL	AB	RLD	2008-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022253-002	VIMPAT	100MG	TABLET / ORAL	AB	RLD	2008-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022253-003	VIMPAT	150MG	TABLET / ORAL	AB	RLD	2008-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022253-004	VIMPAT	200MG	TABLET / ORAL	AB	RLD, RS	2008-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022253-001	VIMPAT	50MG	TABLET / ORAL	AB	RLD	2008-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022253-002	VIMPAT	100MG	TABLET / ORAL	AB	RLD	2008-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022253-003	VIMPAT	150MG	TABLET / ORAL	AB	RLD	2008-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022253-004	VIMPAT	200MG	TABLET / ORAL	AB	RLD, RS	2008-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022253-001	VIMPAT	50MG	TABLET / ORAL	AB	RLD	2008-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022253-002	VIMPAT	100MG	TABLET / ORAL	AB	RLD	2008-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022253-003	VIMPAT	150MG	TABLET / ORAL	AB	RLD	2008-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022253-004	VIMPAT	200MG	TABLET / ORAL	AB	RLD, RS	2008-10-28	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022253-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022253-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022253-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022253-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022253-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022253-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022253-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022253-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022253-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022253-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022253-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022253-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022253-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022253-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022253-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022253-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022253-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022253-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022253-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022253-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022253-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022253-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022253-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022253-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022253-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022253-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022253-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022253-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022253-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022253-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022253-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022253-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022253-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022253-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022253-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022253-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022253-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022253-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022253-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022253-004	AB	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 296 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-001	RE38551	2022-03-17	U-2140	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-001	RE38551	2022-03-17	U-1567	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-001	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-001	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-002	RE38551	2022-03-17	U-1567	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-002	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-002	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-002	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-002	RE38551	2022-03-17	U-2140	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-003	RE38551	2022-03-17	U-2140	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-003	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-003	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-003	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-003	RE38551	2022-03-17	U-1567	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-004	RE38551	2022-03-17	U-2140	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-004	RE38551	2022-03-17	U-1567	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-004	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-004	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022253-004	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022253-001	RE38551	2022-03-17	U-2140	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-001	RE38551	2022-03-17	U-1567	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-001	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-001	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-002	RE38551	2022-03-17	U-1567	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-002	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-002	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-002	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-002	RE38551	2022-03-17	U-2140	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-003	RE38551	2022-03-17	U-2140	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-003	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-003	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-003	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-003	RE38551	2022-03-17	U-1567	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-004	RE38551	2022-03-17	U-2140	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-004	RE38551	2022-03-17	U-1567	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-004	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-004	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022253-004	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`5d02ea3f76ae…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 7 · 268 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022253-001	D-188	2026-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022253-002	D-188	2026-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022253-003	D-188	2026-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022253-004	D-188	2026-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022253-001	D-188	2026-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022253-002	D-188	2026-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022253-003	D-188	2026-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022253-004	D-188	2026-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022253-001	D-188	2026-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022253-002	D-188	2026-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022253-003	D-188	2026-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022253-004	D-188	2026-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022253-001	D-188	2026-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022253-002	D-188	2026-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022253-003	D-188	2026-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022253-004	D-188	2026-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022253-001	D-188	2026-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022253-002	D-188	2026-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022253-003	D-188	2026-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022253-004	D-188	2026-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022253-001	NPP	2024-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022253-001	D-188	2026-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022253-002	NPP	2024-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022253-002	D-188	2026-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022253-003	NPP	2024-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022253-003	D-188	2026-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022253-004	NPP	2024-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022253-004	D-188	2026-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022253-001	NPP	2024-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022253-001	D-188	2026-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022253-002	NPP	2024-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022253-002	D-188	2026-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022253-003	NPP	2024-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022253-003	D-188	2026-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022253-004	NPP	2024-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022253-004	D-188	2026-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022253-001	NPP	2024-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022253-001	D-188	2026-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022253-002	NPP	2024-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022253-002	D-188	2026-04-28	`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
Vimpat	LACOSAMIDE	UCB, Inc.	9e79b42c-38a3-4b2c-a196-a5a1948250e2	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022253 application number: NDA022253 ndc (product): 0131-2478 ndc (product): 0131-2479 ndc (product): 0131-2480 ndc (product): 0131-2477

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0131-2470	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2470	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2470	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2470	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2470	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2470	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2470	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2477	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2478	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2479	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-2480	Vimpat	lacosamide	UCB, Inc.	NDA	Current
70518-0257	Vimpat	lacosamide	REMEDYREPACK INC.	NDA	Current
70518-0257	Vimpat	lacosamide	REMEDYREPACK INC.	NDA	Current
70518-0257	Vimpat	lacosamide	REMEDYREPACK INC.	NDA	Current
70518-0257	Vimpat	lacosamide	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75869	SUPPL	2023-10-20
75868	SUPPL	2023-10-20
75858	SUPPL	2023-10-17
74135	SUPPL	2023-05-01
74129	SUPPL	2023-05-01
72230	SUPPL	2022-10-03
72229	SUPPL	2022-10-03
72205	SUPPL	2022-10-03
71118	SUPPL	2022-05-20
71117	SUPPL	2022-05-20
71113	SUPPL	2022-05-20
69025	SUPPL	2021-10-19
69003	SUPPL	2021-10-15
69002	SUPPL	2021-10-15
68647	SUPPL	2021-09-20
68646	SUPPL	2021-09-20
68636	SUPPL	2021-09-17
65255	SUPPL	2020-11-17
65254	SUPPL	2020-11-17
65238	SUPPL	2020-11-16
65237	SUPPL	2020-11-16
65236	SUPPL	2020-11-16
65235	SUPPL	2020-11-16
59042	SUPPL	2019-06-12
59023	SUPPL	2019-06-12
59022	SUPPL	2019-06-12
57569	SUPPL	2019-02-13
57162	SUPPL	2019-01-10
56677	SUPPL	2018-12-07
56442	SUPPL	2018-11-23
50325	SUPPL	2017-11-07
47751	SUPPL	2017-03-29
47708	SUPPL	2017-03-27
17141	SUPPL	2015-07-13
7107	SUPPL	2015-07-13
38437	SUPPL	2014-09-03
29462	SUPPL	2014-09-03
29461	SUPPL	2014-09-03
17140	SUPPL	2014-09-03
38438	SUPPL	2014-08-19
7106	SUPPL	2014-08-14
38435	SUPPL	2014-01-17
29460	SUPPL	2014-01-17
38434	SUPPL	2013-09-27
17138	SUPPL	2013-09-27
29457	SUPPL	2013-09-26
7104	SUPPL	2013-09-26
7105	SUPPL	2013-04-23
38436	SUPPL	2013-04-19
38433	SUPPL	2013-02-12
7103	SUPPL	2013-02-12
29459	SUPPL	2013-02-07
17139	SUPPL	2013-02-06
17137	SUPPL	2012-08-28
29458	SUPPL	2011-08-12
7102	SUPPL	2010-05-04
7101	SUPPL	2010-01-20
38432	SUPPL	2009-11-20
44716	ORIG	2008-12-17
21971	ORIG	2008-12-17
7100	ORIG	2008-10-31
17136	ORIG	2008-10-29
63109	SUPPL	1900-01-01
63108	SUPPL	1900-01-01
63107	SUPPL	1900-01-01