Application 205836

Type: NDA
Sponsor: UCB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BRIVIACT	BRIVARACETAM	TABLET;ORAL	10MG	Yes	No
002	BRIVIACT	BRIVARACETAM	TABLET;ORAL	25MG	Yes	No
003	BRIVIACT	BRIVARACETAM	TABLET;ORAL	50MG	Yes	No
004	BRIVIACT	BRIVARACETAM	TABLET;ORAL	75MG	Yes	No
005	BRIVIACT	BRIVARACETAM	TABLET;ORAL	100MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205836-001	BRIVIACT	BRIVARACETAM	10MG	TABLET / ORAL	AB	RLD	2016-05-12
N205836-002	BRIVIACT	BRIVARACETAM	25MG	TABLET / ORAL	AB	RLD	2016-05-12
N205836-003	BRIVIACT	BRIVARACETAM	50MG	TABLET / ORAL	AB	RLD	2016-05-12
N205836-004	BRIVIACT	BRIVARACETAM	75MG	TABLET / ORAL	AB	RLD	2016-05-12
N205836-005	BRIVIACT	BRIVARACETAM	100MG	TABLET / ORAL	AB	RLD, RS	2016-05-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N205836-001	AB
N205836-002	AB
N205836-003	AB
N205836-004	AB
N205836-005	AB

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205836-001	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25
N205836-001	10729653	2030-04-09		Drug product	2020-08-18
N205836-002	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25
N205836-002	10729653	2030-04-09		Drug product	2020-08-18
N205836-003	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25
N205836-003	10729653	2030-04-09		Drug product	2020-08-18
N205836-004	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25
N205836-004	10729653	2030-04-09		Drug product	2020-08-18
N205836-005	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25
N205836-005	10729653	2030-04-09		Drug product	2020-08-18

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 · 205 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	N205836-001	BRIVIACT	10MG	TABLET / ORAL	AB	RLD	2016-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205836-002	BRIVIACT	25MG	TABLET / ORAL	AB	RLD	2016-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205836-003	BRIVIACT	50MG	TABLET / ORAL	AB	RLD	2016-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205836-004	BRIVIACT	75MG	TABLET / ORAL	AB	RLD	2016-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205836-005	BRIVIACT	100MG	TABLET / ORAL	AB	RLD, RS	2016-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-001	BRIVIACT	10MG	TABLET / ORAL	AB	RLD	2016-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-002	BRIVIACT	25MG	TABLET / ORAL	AB	RLD	2016-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-003	BRIVIACT	50MG	TABLET / ORAL	AB	RLD	2016-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-004	BRIVIACT	75MG	TABLET / ORAL	AB	RLD	2016-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-005	BRIVIACT	100MG	TABLET / ORAL	AB	RLD, RS	2016-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205836-001	BRIVIACT	10MG	TABLET / ORAL		RLD	2016-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205836-002	BRIVIACT	25MG	TABLET / ORAL		RLD	2016-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205836-003	BRIVIACT	50MG	TABLET / ORAL		RLD	2016-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205836-004	BRIVIACT	75MG	TABLET / ORAL		RLD	2016-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205836-005	BRIVIACT	100MG	TABLET / ORAL		RLD, RS	2016-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205836-001	BRIVIACT	10MG	TABLET / ORAL		RLD	2016-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205836-002	BRIVIACT	25MG	TABLET / ORAL		RLD	2016-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205836-003	BRIVIACT	50MG	TABLET / ORAL		RLD	2016-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205836-004	BRIVIACT	75MG	TABLET / ORAL		RLD	2016-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205836-005	BRIVIACT	100MG	TABLET / ORAL		RLD, RS	2016-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205836-001	BRIVIACT	10MG	TABLET / ORAL		RLD	2016-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205836-002	BRIVIACT	25MG	TABLET / ORAL		RLD	2016-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205836-003	BRIVIACT	50MG	TABLET / ORAL		RLD	2016-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205836-004	BRIVIACT	75MG	TABLET / ORAL		RLD	2016-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205836-005	BRIVIACT	100MG	TABLET / ORAL		RLD, RS	2016-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205836-001	BRIVIACT	10MG	TABLET / ORAL		RLD	2016-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205836-002	BRIVIACT	25MG	TABLET / ORAL		RLD	2016-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205836-003	BRIVIACT	50MG	TABLET / ORAL		RLD	2016-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205836-004	BRIVIACT	75MG	TABLET / ORAL		RLD	2016-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205836-005	BRIVIACT	100MG	TABLET / ORAL		RLD, RS	2016-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205836-001	BRIVIACT	10MG	TABLET / ORAL		RLD	2016-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205836-002	BRIVIACT	25MG	TABLET / ORAL		RLD	2016-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205836-003	BRIVIACT	50MG	TABLET / ORAL		RLD	2016-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205836-004	BRIVIACT	75MG	TABLET / ORAL		RLD	2016-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205836-005	BRIVIACT	100MG	TABLET / ORAL		RLD, RS	2016-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205836-001	BRIVIACT	10MG	TABLET / ORAL		RLD	2016-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205836-002	BRIVIACT	25MG	TABLET / ORAL		RLD	2016-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205836-003	BRIVIACT	50MG	TABLET / ORAL		RLD	2016-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205836-004	BRIVIACT	75MG	TABLET / ORAL		RLD	2016-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205836-005	BRIVIACT	100MG	TABLET / ORAL		RLD, RS	2016-05-12	`5bbf6a4d5a75…`

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	N205836-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205836-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205836-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205836-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205836-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-005	AB	1	`31067a03dcf5…`
2023-01-26 05:58 UTC	2023-01	N205836-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N205836-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N205836-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N205836-004	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N205836-005	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205836-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205836-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205836-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205836-004	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205836-005	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205836-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N205836-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N205836-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N205836-004	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N205836-005	AB	1	`f41ea6bd6efb…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205836-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205836-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205836-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205836-004	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205836-005	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205836-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205836-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205836-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205836-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205836-005	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 480 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	N205836-001	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205836-001	10729653	2030-04-09		Drug product	2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205836-002	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205836-002	10729653	2030-04-09		Drug product	2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205836-003	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205836-003	10729653	2030-04-09		Drug product	2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205836-004	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205836-004	10729653	2030-04-09		Drug product	2020-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205836-005	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205836-005	10729653	2030-04-09		Drug product	2020-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-001	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-001	10729653	2030-04-09		Drug product	2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-002	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-002	10729653	2030-04-09		Drug product	2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-003	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-003	10729653	2030-04-09		Drug product	2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-004	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-004	10729653	2030-04-09		Drug product	2020-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-005	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205836-005	10729653	2030-04-09		Drug product	2020-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205836-001	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205836-001	10729653	2030-04-09		Drug product	2020-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205836-002	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205836-002	10729653	2030-04-09		Drug product	2020-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205836-003	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205836-003	10729653	2030-04-09		Drug product	2020-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205836-004	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205836-004	10729653	2030-04-09		Drug product	2020-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205836-005	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205836-005	10729653	2030-04-09		Drug product	2020-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205836-001	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205836-001	10729653	2030-04-09		Drug product	2020-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205836-002	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205836-002	10729653	2030-04-09		Drug product	2020-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205836-003	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205836-003	10729653	2030-04-09		Drug product	2020-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205836-004	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205836-004	10729653	2030-04-09		Drug product	2020-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205836-005	6911461	2026-02-21	U-2295	Drug substance, Drug product	2016-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205836-005	10729653	2030-04-09		Drug product	2020-08-18	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 195 observed states.

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	N205836-001	NPP	2024-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205836-002	NPP	2024-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205836-003	NPP	2024-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205836-004	NPP	2024-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205836-005	NPP	2024-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205836-001	NPP	2024-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205836-002	NPP	2024-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205836-003	NPP	2024-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205836-004	NPP	2024-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205836-005	NPP	2024-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205836-001	NPP	2024-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205836-002	NPP	2024-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205836-003	NPP	2024-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205836-004	NPP	2024-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205836-005	NPP	2024-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205836-001	NPP	2024-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205836-002	NPP	2024-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205836-003	NPP	2024-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205836-004	NPP	2024-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205836-005	NPP	2024-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205836-001	NPP	2024-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205836-002	NPP	2024-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205836-003	NPP	2024-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205836-004	NPP	2024-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205836-005	NPP	2024-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205836-001	NPP	2024-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205836-002	NPP	2024-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205836-003	NPP	2024-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205836-004	NPP	2024-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205836-005	NPP	2024-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205836-001	NPP	2024-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205836-002	NPP	2024-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205836-003	NPP	2024-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205836-004	NPP	2024-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205836-005	NPP	2024-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205836-001	NPP	2024-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205836-002	NPP	2024-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205836-003	NPP	2024-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205836-004	NPP	2024-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205836-005	NPP	2024-08-27	`1e350fbaab3a…`

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): 205836 application number: NDA205836 ndc (product): 50474-670 ndc (product): 50474-370 ndc (product): 50474-470 ndc (product): 50474-570 ndc (product): 50474-770

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50474-370	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-370	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-370	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-370	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-370	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-470	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-470	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-470	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-470	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-470	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-570	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-570	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-570	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-570	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-570	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-670	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-670	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-670	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-670	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-670	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-770	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-770	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-770	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-770	Briviact	brivaracetam	UCB, Inc.	NDA	Current
50474-770	Briviact	brivaracetam	UCB, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83260	SUPPL	2025-09-02
83259	SUPPL	2025-09-02
83240	SUPPL	2025-08-29
74302	SUPPL	2023-05-18
74287	SUPPL	2023-05-18
69605	SUPPL	2021-12-16
69600	SUPPL	2021-12-16
68536	SUPPL	2021-09-03
68500	SUPPL	2021-08-31
68499	SUPPL	2021-08-31
68492	SUPPL	2021-08-31
54201	SUPPL	2018-05-16
54181	SUPPL	2018-05-14
54180	SUPPL	2018-05-14
49793	SUPPL	2017-09-19
49742	SUPPL	2017-09-15
47887	ORIG	2017-04-07
32747	SUPPL	2016-06-06
19691	SUPPL	2016-06-06
23006	ORIG	2016-03-30
40515	ORIG	2016-02-19
32746	ORIG	2016-02-19