Application 022255

Type: NDA
Sponsor: UCB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIMPAT	LACOSAMIDE	SOLUTION;ORAL	10MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022255-001	VIMPAT	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022255-001	AA

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022255-001	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 2 · 42 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
2026-08-18 06:07:40	2026-07	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL		RLD, RS	2010-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL		RLD, RS	2010-04-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL		RLD, RS	2010-04-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL		RLD, RS	2010-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL		RLD, RS	2010-04-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL		RLD, RS	2010-04-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL		RLD, RS	2010-04-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL		RLD, RS	2010-04-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL		RLD, RS	2010-04-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL		RLD, RS	2010-04-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL		RLD, RS	2010-04-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL		RLD, RS	2010-04-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022255-001	VIMPAT	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	2010-04-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022255-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022255-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022255-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022255-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022255-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022255-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022255-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022255-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022255-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022255-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022255-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022255-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022255-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022255-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022255-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022255-001	AA	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022255-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022255-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022255-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022255-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022255-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022255-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022255-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022255-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022255-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022255-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022255-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022255-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022255-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022255-001	AA	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 74 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	N022255-001	RE38551	2022-03-17	U-2140	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022255-001	RE38551	2022-03-17	U-1567	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022255-001	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022255-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022255-001	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022255-001	RE38551	2022-03-17	U-2140	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022255-001	RE38551	2022-03-17	U-1567	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022255-001	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022255-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022255-001	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022255-001	RE38551	2022-03-17	U-2140	Drug substance, Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022255-001	RE38551	2022-03-17	U-1567	Drug substance, Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022255-001	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022255-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022255-001	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022255-001	RE38551	2022-03-17	U-2140	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022255-001	RE38551	2022-03-17	U-1567	Drug substance, Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022255-001	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022255-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022255-001	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022255-001	RE38551	2022-03-17	U-1567	Drug substance, Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022255-001	RE38551	2022-03-17	U-2140	Drug substance, Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022255-001	RE38551	2022-03-17	U-2140	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022255-001	RE38551	2022-03-17	U-1567	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022255-001	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022255-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022255-001	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022255-001	RE38551	2022-03-17	U-2140	Drug substance, Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022255-001	RE38551	2022-03-17	U-1567	Drug substance, Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022255-001	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022255-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022255-001	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022255-001	RE38551	2022-03-17	U-2140	Drug substance, Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022255-001	RE38551	2022-03-17	U-1567	Drug substance, Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022255-001	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022255-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022255-001	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022255-001	RE38551	2022-03-17	U-2140	Drug substance, Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022255-001	RE38551	2022-03-17	U-1567	Drug substance, Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022255-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`8869cabd3fbd…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N022255-001	D-188	2026-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022255-001	D-188	2026-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022255-001	D-188	2026-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022255-001	D-188	2026-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022255-001	D-188	2026-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022255-001	D-188	2026-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022255-001	NPP	2024-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022255-001	D-188	2026-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022255-001	NPP	2024-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022255-001	D-188	2026-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022255-001	NPP	2024-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022255-001	D-188	2026-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022255-001	NPP	2024-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022255-001	D-188	2026-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022255-001	NPP	2024-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022255-001	D-188	2026-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022255-001	NPP	2024-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022255-001	D-188	2026-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022255-001	NPP	2024-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022255-001	D-188	2026-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022255-001	NPP	2024-10-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022255-001	D-188	2026-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022255-001	NPP	2024-10-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022255-001	D-188	2026-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022255-001	I-878	2023-11-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022255-001	NPP	2024-10-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022255-001	I-878	2023-11-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022255-001	NPP	2024-10-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022255-001	I-878	2023-11-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022255-001	NPP	2024-10-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022255-001	NPP	2020-11-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022255-001	I-878	2023-11-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022255-001	NPP	2024-10-14	`bb7c543d1eb4…`
2020-12-22 03:56 UTC	2020-12	N022255-001	NPP	2020-11-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022255-001	NPP	2020-11-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022255-001	NPP	2020-11-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022255-001	NPP	2020-11-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022255-001	NPP	2020-11-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022255-001	NPP	2024-10-14	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022255-001	D-188	2026-04-28	`6a51e52b5d6a…`

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): 022255 application number: NDA022255 ndc (product): 0131-5410

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0131-5410	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-5410	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-5410	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-5410	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-5410	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-5410	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-5410	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-5410	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-5410	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-5410	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-5410	Vimpat	lacosamide	UCB, Inc.	NDA	Current
66689-107	Lacosamide	Lacosamide	VistaPharm, Inc.	NDA	Current
66689-107	Lacosamide	Lacosamide	VistaPharm, Inc.	NDA	Current
66689-108	Lacosamide	Lacosamide	VistaPharm, Inc.	NDA	Current
66689-108	Lacosamide	Lacosamide	VistaPharm, Inc.	NDA	Current
66689-109	Lacosamide	Lacosamide	VistaPharm, Inc.	NDA	Current
66689-109	Lacosamide	Lacosamide	VistaPharm, Inc.	NDA	Current
66689-110	Lacosamide	Lacosamide	VistaPharm, Inc.	NDA	Current
66689-110	Lacosamide	Lacosamide	VistaPharm, Inc.	NDA	Current
70166-617	Vimpat	lacosamide	Lohxa	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75873	SUPPL	2023-10-20
75872	SUPPL	2023-10-20
75830	SUPPL	2023-10-17
74139	SUPPL	2023-05-01
74131	SUPPL	2023-05-01
72234	SUPPL	2022-10-03
72233	SUPPL	2022-10-03
72207	SUPPL	2022-10-03
71119	SUPPL	2022-05-20
71114	SUPPL	2022-05-20
69027	SUPPL	2021-10-19
69007	SUPPL	2021-10-15
69006	SUPPL	2021-10-15
68651	SUPPL	2021-09-20
68650	SUPPL	2021-09-20
68638	SUPPL	2021-09-17
65259	SUPPL	2020-11-17
65258	SUPPL	2020-11-17
65246	SUPPL	2020-11-16
65245	SUPPL	2020-11-16
65244	SUPPL	2020-11-16
65243	SUPPL	2020-11-16
59043	SUPPL	2019-06-12
59025	SUPPL	2019-06-12
59020	SUPPL	2019-06-12
57571	SUPPL	2019-02-13
57164	SUPPL	2019-01-10
56679	SUPPL	2018-12-07
56440	SUPPL	2018-11-23
50329	SUPPL	2017-11-07
47749	SUPPL	2017-03-29
47704	SUPPL	2017-03-27
17154	SUPPL	2015-07-13
7118	SUPPL	2015-07-13
38449	SUPPL	2014-09-03
29477	SUPPL	2014-09-03
29476	SUPPL	2014-09-03
17152	SUPPL	2014-09-03
7117	SUPPL	2014-08-14
17153	SUPPL	2014-08-13
38448	SUPPL	2014-01-17
7115	SUPPL	2014-01-17
38447	SUPPL	2013-09-27
17149	SUPPL	2013-09-27
29474	SUPPL	2013-09-26
7113	SUPPL	2013-09-26
7116	SUPPL	2013-04-23
17151	SUPPL	2013-04-19
17148	SUPPL	2013-02-12
7112	SUPPL	2013-02-12
7114	SUPPL	2013-02-07
17150	SUPPL	2013-02-06
17147	ORIG	2012-08-28
29475	SUPPL	2011-08-12
44717	ORIG	2011-02-17
42468	ORIG	2010-12-01
7111	ORIG	2010-05-04