Application 022254

Type: NDA
Sponsor: UCB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIMPAT	LACOSAMIDE	SOLUTION;INTRAVENOUS	200MG/20ML (10MG/ML)	Yes	Yes

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

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
N022254-001	VIMPAT	LACOSAMIDE	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022254-001	AP

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022254-001	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 · 41 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	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-10-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-10-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-10-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-10-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-10-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-10-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-10-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-10-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-10-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-10-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-10-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-10-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022254-001	VIMPAT	200MG/20ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-10-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022254-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022254-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022254-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022254-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022254-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022254-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022254-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022254-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022254-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022254-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022254-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022254-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022254-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022254-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022254-001	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022254-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022254-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022254-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022254-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022254-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022254-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022254-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022254-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022254-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022254-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022254-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022254-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022254-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022254-001	AP	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	N022254-001	RE38551	2022-03-17	U-1565	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022254-001	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022254-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022254-001	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022254-001	RE38551	2022-03-17	U-1568	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022254-001	RE38551	2022-03-17	U-1565	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022254-001	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022254-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022254-001	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022254-001	RE38551	2022-03-17	U-1568	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022254-001	RE38551	2022-03-17	U-1565	Drug substance, Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022254-001	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022254-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022254-001	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022254-001	RE38551	2022-03-17	U-1568	Drug substance, Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022254-001	RE38551	2022-03-17	U-1568	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022254-001	RE38551	2022-03-17	U-1565	Drug substance, Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022254-001	RE38551	2022-03-17	U-1568	Drug substance, Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022254-001	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022254-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022254-001	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022254-001	RE38551	2022-03-17	U-1565	Drug substance, Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022254-001	RE38551	2022-03-17	U-1565	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022254-001	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022254-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022254-001	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022254-001	RE38551	2022-03-17	U-1568	Drug substance, Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022254-001	RE38551	2022-03-17	U-1565	Drug substance, Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022254-001	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022254-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022254-001	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022254-001	RE38551	2022-03-17	U-1568	Drug substance, Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022254-001	RE38551	2022-03-17	U-1565	Drug substance, Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022254-001	RE38551	2022-03-17	U-2999	Drug substance, Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022254-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022254-001	RE38551	2022-03-17	U-2990	Drug substance, Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022254-001	RE38551	2022-03-17	U-1568	Drug substance, Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022254-001	RE38551	2022-03-17	U-1568	Drug substance, Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022254-001	RE38551	2022-03-17	U-1565	Drug substance, Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022254-001	RE38551	2022-03-17	U-2989	Drug substance, Drug product	`8869cabd3fbd…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 82 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	N022254-001	D-188	2026-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022254-001	D-188	2026-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022254-001	D-188	2026-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022254-001	D-188	2026-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022254-001	D-188	2026-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022254-001	NPP	2024-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022254-001	D-188	2026-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022254-001	NPP	2024-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022254-001	D-188	2026-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022254-001	NPP	2024-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022254-001	D-188	2026-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022254-001	NPP	2024-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022254-001	D-188	2026-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022254-001	NPP	2024-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022254-001	D-188	2026-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022254-001	NPP	2024-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022254-001	D-188	2026-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022254-001	NPP	2024-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022254-001	D-188	2026-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022254-001	NPP	2024-10-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022254-001	D-188	2026-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022254-001	NPP	2024-10-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022254-001	D-188	2026-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022254-001	I-878	2023-11-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022254-001	NPP	2023-11-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022254-001	NPP	2024-10-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022254-001	I-878	2023-11-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022254-001	NPP	2023-11-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022254-001	NPP	2024-10-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022254-001	I-878	2023-11-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022254-001	NPP	2023-11-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022254-001	NPP	2024-10-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022254-001	M-217	2020-11-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022254-001	I-878	2023-11-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022254-001	NPP	2023-11-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022254-001	NPP	2024-10-14	`bb7c543d1eb4…`
2020-12-22 03:56 UTC	2020-12	N022254-001	M-217	2020-11-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022254-001	M-217	2020-11-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022254-001	M-217	2020-11-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022254-001	M-217	2020-11-03	`b00525d2431f…`

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): 022254 application number: NDA022254 ndc (product): 0131-1810

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0131-1810	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-1810	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-1810	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-1810	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-1810	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-1810	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-1810	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-1810	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-1810	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-1810	Vimpat	lacosamide	UCB, Inc.	NDA	Current
0131-1810	Vimpat	lacosamide	UCB, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75871	SUPPL	2023-10-20
75870	SUPPL	2023-10-20
75829	SUPPL	2023-10-17
74137	SUPPL	2023-05-01
74130	SUPPL	2023-05-01
72232	SUPPL	2022-10-03
72231	SUPPL	2022-10-03
72206	SUPPL	2022-10-03
71116	SUPPL	2022-05-20
71112	SUPPL	2022-05-20
69026	SUPPL	2021-10-19
69005	SUPPL	2021-10-15
69004	SUPPL	2021-10-15
68649	SUPPL	2021-09-20
68648	SUPPL	2021-09-20
68637	SUPPL	2021-09-17
65257	SUPPL	2020-11-17
65256	SUPPL	2020-11-17
65242	SUPPL	2020-11-16
65241	SUPPL	2020-11-16
65240	SUPPL	2020-11-16
65239	SUPPL	2020-11-16
59044	SUPPL	2019-06-12
59024	SUPPL	2019-06-12
59021	SUPPL	2019-06-12
57570	SUPPL	2019-02-13
57163	SUPPL	2019-01-10
56678	SUPPL	2018-12-07
56438	SUPPL	2018-11-23
50327	SUPPL	2017-11-07
47750	SUPPL	2017-03-29
47706	SUPPL	2017-03-27
38446	SUPPL	2015-07-13
29473	SUPPL	2015-07-13
38445	SUPPL	2014-09-03
29472	SUPPL	2014-09-03
29471	SUPPL	2014-09-03
17145	SUPPL	2014-09-03
7110	SUPPL	2014-08-14
17146	SUPPL	2014-08-13
38443	SUPPL	2014-01-17
7109	SUPPL	2014-01-17
38442	SUPPL	2013-09-27
17143	SUPPL	2013-09-27
29467	SUPPL	2013-09-26
7108	SUPPL	2013-09-26
29470	SUPPL	2013-04-23
38444	SUPPL	2013-04-19
38441	SUPPL	2013-02-12
29466	SUPPL	2013-02-12
29469	SUPPL	2013-02-07
17144	SUPPL	2013-02-06
38440	SUPPL	2012-08-28
29468	SUPPL	2011-08-12
29465	SUPPL	2010-05-04
29464	SUPPL	2010-01-20
17142	SUPPL	2009-11-20
42467	ORIG	2008-12-17
24266	ORIG	2008-12-17
29463	ORIG	2008-10-31
38439	ORIG	2008-10-29