Application 205837

Type: NDA
Sponsor: UCB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BRIVIACT	BRIVARACETAM	SOLUTION;INTRAVENOUS	50MG/5ML (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
N205837-001	BRIVIACT	BRIVARACETAM	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2016-05-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N205837-001	AP

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25
N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205837-001	BRIVIACT	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205837-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 118 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205837-001	6911461	2026-02-21	U-1815	Drug substance, Drug product	2016-02-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205837-001	6911461	2026-02-21	U-2130	Drug substance, Drug product	2016-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205837-001	6784197	2021-02-21	U-2130	Drug substance, Drug product	2016-02-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205837-001	6784197	2021-02-21	U-1815	Drug substance, Drug product	2016-02-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205837-001	6911461	2021-02-21	U-1815	Drug substance, Drug product	2016-02-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205837-001	6911461	2021-02-21	U-2130	Drug substance, Drug product	2016-02-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205837-001	8492416	2021-02-21	U-2130		2016-02-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205837-001	8492416	2021-02-21	U-1815		2016-02-25	`74a2ff9319b5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205837-001	NPP	2024-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205837-001	NPP	2024-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205837-001	NPP	2024-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205837-001	NPP	2024-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205837-001	NPP	2024-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205837-001	NPP	2024-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205837-001	NPP	2024-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205837-001	NPP	2024-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205837-001	NPP	2024-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205837-001	NPP	2024-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205837-001	NPP	2024-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205837-001	NPP	2024-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205837-001	NCE	2021-05-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205837-001	NPP	2024-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205837-001	NCE	2021-05-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205837-001	NPP	2024-08-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205837-001	NCE	2021-05-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205837-001	NCE	2021-05-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205837-001	NCE	2021-05-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205837-001	NCE	2021-05-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205837-001	NCE	2021-05-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205837-001	NCE	2021-05-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205837-001	NCE	2021-05-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205837-001	NPP	2024-08-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205837-001	NPP	2024-08-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205837-001	NPP	2024-08-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205837-001	NPP	2024-08-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205837-001	NPP	2024-08-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205837-001	NPP	2024-08-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205837-001	NPP	2024-08-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205837-001	NPP	2024-08-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205837-001	NPP	2024-08-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205837-001	NPP	2024-08-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205837-001	NPP	2024-08-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205837-001	NPP	2024-08-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205837-001	NPP	2024-08-27	`cb3db0bc1861…`

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
Briviact	BRIVARACETAM	UCB, Inc.	3cf2f439-0e97-443e-8e33-25ecef616f6c	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205837 application number: NDA205837 ndc (product): 50474-970

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50474-970	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-970	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-970	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-970	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-970	Briviact	brivaracetam	UCB, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83262	SUPPL	2025-09-02
83261	SUPPL	2025-09-02
83241	SUPPL	2025-08-29
74303	SUPPL	2023-05-18
74289	SUPPL	2023-05-18
69604	SUPPL	2021-12-16
69601	SUPPL	2021-12-16
68537	SUPPL	2021-09-03
68502	SUPPL	2021-08-31
68501	SUPPL	2021-08-31
68493	SUPPL	2021-08-31
54202	SUPPL	2018-05-16
54185	SUPPL	2018-05-14
54182	SUPPL	2018-05-14
49794	SUPPL	2017-09-19
49740	SUPPL	2017-09-15
47888	ORIG	2017-04-07
40516	SUPPL	2016-06-06
32748	SUPPL	2016-06-06
43505	ORIG	2016-03-30
19692	ORIG	2016-02-19
10515	ORIG	2016-02-19