Application 214501

Type: ANDA
Sponsor: ZYDUS PHARMS USA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A214501-001	BRIVARACETAM	BRIVARACETAM	10MG	TABLET / ORAL	AB	2022-10-03
A214501-002	BRIVARACETAM	BRIVARACETAM	25MG	TABLET / ORAL	AB	2022-10-03
A214501-003	BRIVARACETAM	BRIVARACETAM	50MG	TABLET / ORAL	AB	2022-10-03
A214501-004	BRIVARACETAM	BRIVARACETAM	75MG	TABLET / ORAL	AB	2022-10-03
A214501-005	BRIVARACETAM	BRIVARACETAM	100MG	TABLET / ORAL	AB	2022-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214501-001	AB
A214501-002	AB
A214501-003	AB
A214501-004	AB
A214501-005	AB

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 2 of 4 · 140 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214501-001	BRIVARACETAM	10MG	TABLET / ORAL	2022-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214501-002	BRIVARACETAM	25MG	TABLET / ORAL	2022-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214501-003	BRIVARACETAM	50MG	TABLET / ORAL	2022-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214501-004	BRIVARACETAM	75MG	TABLET / ORAL	2022-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214501-005	BRIVARACETAM	100MG	TABLET / ORAL	2022-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214501-001	BRIVARACETAM	10MG	TABLET / ORAL	2022-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214501-002	BRIVARACETAM	25MG	TABLET / ORAL	2022-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214501-003	BRIVARACETAM	50MG	TABLET / ORAL	2022-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214501-004	BRIVARACETAM	75MG	TABLET / ORAL	2022-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214501-005	BRIVARACETAM	100MG	TABLET / ORAL	2022-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214501-001	BRIVARACETAM	10MG	TABLET / ORAL	2022-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214501-002	BRIVARACETAM	25MG	TABLET / ORAL	2022-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214501-003	BRIVARACETAM	50MG	TABLET / ORAL	2022-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214501-004	BRIVARACETAM	75MG	TABLET / ORAL	2022-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214501-005	BRIVARACETAM	100MG	TABLET / ORAL	2022-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214501-001	BRIVARACETAM	10MG	TABLET / ORAL	2022-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214501-002	BRIVARACETAM	25MG	TABLET / ORAL	2022-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214501-003	BRIVARACETAM	50MG	TABLET / ORAL	2022-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214501-004	BRIVARACETAM	75MG	TABLET / ORAL	2022-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214501-005	BRIVARACETAM	100MG	TABLET / ORAL	2022-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214501-001	BRIVARACETAM	10MG	TABLET / ORAL	2022-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214501-002	BRIVARACETAM	25MG	TABLET / ORAL	2022-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214501-003	BRIVARACETAM	50MG	TABLET / ORAL	2022-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214501-004	BRIVARACETAM	75MG	TABLET / ORAL	2022-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214501-005	BRIVARACETAM	100MG	TABLET / ORAL	2022-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214501-001	BRIVARACETAM	10MG	TABLET / ORAL	2022-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214501-002	BRIVARACETAM	25MG	TABLET / ORAL	2022-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214501-003	BRIVARACETAM	50MG	TABLET / ORAL	2022-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214501-004	BRIVARACETAM	75MG	TABLET / ORAL	2022-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214501-005	BRIVARACETAM	100MG	TABLET / ORAL	2022-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214501-001	BRIVARACETAM	10MG	TABLET / ORAL	2022-10-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214501-002	BRIVARACETAM	25MG	TABLET / ORAL	2022-10-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214501-003	BRIVARACETAM	50MG	TABLET / ORAL	2022-10-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214501-004	BRIVARACETAM	75MG	TABLET / ORAL	2022-10-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214501-005	BRIVARACETAM	100MG	TABLET / ORAL	2022-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214501-001	BRIVARACETAM	10MG	TABLET / ORAL	2022-10-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214501-002	BRIVARACETAM	25MG	TABLET / ORAL	2022-10-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214501-003	BRIVARACETAM	50MG	TABLET / ORAL	2022-10-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214501-004	BRIVARACETAM	75MG	TABLET / ORAL	2022-10-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214501-005	BRIVARACETAM	100MG	TABLET / ORAL	2022-10-03	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214501-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214501-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214501-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214501-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214501-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214501-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214501-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214501-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214501-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214501-005	AB	1	`caaa826d4ba7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214501-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214501-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214501-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214501-004	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214501-005	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214501-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214501-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214501-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214501-004	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214501-005	AB	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214501-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214501-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214501-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214501-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214501-005	AB	1	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
brivaracetam	BRIVARACETAM	Zydus Lifesciences Limited	67c4db20-ba4d-4640-9e9c-6949b85429e3	2026-01-27		Exact identifier application applno (ANDA): 214501 application number: ANDA214501
brivaracetam	BRIVARACETAM	Zydus Pharmaceuticals USA Inc.	d54ca946-2ddf-4a67-87c9-20a814bfd2dc	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214501 application number: ANDA214501

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68082	ORIG	2021-07-14