Application 214848

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BRIVARACETAM	BRIVARACETAM	TABLET;ORAL	50MG	No	No
002	BRIVARACETAM	BRIVARACETAM	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A214848-001	BRIVARACETAM	BRIVARACETAM	50MG	TABLET / ORAL	AB	2023-01-06
A214848-002	BRIVARACETAM	BRIVARACETAM	100MG	TABLET / ORAL	AB	2023-01-06
A214848-003	BRIVARACETAM	BRIVARACETAM	10MG	TABLET / ORAL	AB	2026-07-13
A214848-004	BRIVARACETAM	BRIVARACETAM	25MG	TABLET / ORAL	AB	2026-07-13
A214848-005	BRIVARACETAM	BRIVARACETAM	75MG	TABLET / ORAL	AB	2026-07-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214848-001	AB
A214848-002	AB
A214848-003	AB
A214848-004	AB
A214848-005	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 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL	AB	2023-01-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL	AB	2023-01-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214848-003	BRIVARACETAM	10MG	TABLET / ORAL	AB	2026-07-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214848-004	BRIVARACETAM	25MG	TABLET / ORAL	AB	2026-07-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214848-005	BRIVARACETAM	75MG	TABLET / ORAL	AB	2026-07-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL	AB	2023-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL	AB	2023-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214848-003	BRIVARACETAM	10MG	TABLET / ORAL	AB	2026-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214848-004	BRIVARACETAM	25MG	TABLET / ORAL	AB	2026-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214848-005	BRIVARACETAM	75MG	TABLET / ORAL	AB	2026-07-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL	AB	2023-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL	AB	2023-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214848-003	BRIVARACETAM	10MG	TABLET / ORAL	AB	2026-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214848-004	BRIVARACETAM	25MG	TABLET / ORAL	AB	2026-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214848-005	BRIVARACETAM	75MG	TABLET / ORAL	AB	2026-07-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL	AB	2023-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL	AB	2023-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214848-002	BRIVARACETAM	100MG	TABLET / ORAL		2023-01-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214848-001	BRIVARACETAM	50MG	TABLET / ORAL		2023-01-06	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A214848-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214848-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214848-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214848-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214848-005	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214848-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214848-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214848-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214848-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214848-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214848-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214848-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214848-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214848-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214848-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214848-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214848-002	AB	1	`011fe1cb6892…`
2023-01-26 05:58 UTC	2023-01	A214848-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214848-002	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214848-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214848-002	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 · 18 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	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: BRIVARACETAM
brivaracetam	BRIVARACETAM	Novadoz Pharmaceuticals LLC	11ca0e1d-1c0d-4357-9ebd-ee1e87185dde	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: brivaracetam generic name: BRIVARACETAM
BRIVARACETAM	BRIVARACETAM	Aurobindo Pharma Limited	57cfb2c3-395d-0892-e063-6294a90a1064	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: BRIVARACETAM generic name: BRIVARACETAM
brivaracetam	BRIVARACETAM	SolarisPharmaCorporation	49f726ec-e51b-7516-e063-6294a90ae684	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: brivaracetam generic name: BRIVARACETAM
brivaracetam	BRIVARACETAM	ScieGen Pharmaceuticals, Inc.	bdbb6756-654c-46f1-a85c-7d5d1a89685a	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: brivaracetam generic name: BRIVARACETAM
brivaracetam	BRIVARACETAM	AvKARE	5115c5b4-7a23-89f2-e063-6294a90a222a	2026-03-12	Warnings, Adverse reactions	Name fallback brand name: brivaracetam generic name: BRIVARACETAM
BRIVARACETAM	BRIVARACETAM	Lupin Pharmaceuticals, Inc.	260468dd-a604-488a-a47b-b6d82edcca37	2026-02-28	Warnings, Adverse reactions	Name fallback brand name: BRIVARACETAM generic name: BRIVARACETAM
Brivaracetam	BRIVARACETAM	Apotex Corp.	1915620d-4f37-56c2-437e-8362bb462d07	2026-02-25	Warnings, Adverse reactions	Name fallback brand name: Brivaracetam generic name: BRIVARACETAM
BRIVARACETAM	BRIVARACETAM	Micro Labs Limited	c054a1c9-2aa7-473b-a04b-622596f36c95	2026-02-24	Warnings, Adverse reactions	Name fallback brand name: BRIVARACETAM generic name: BRIVARACETAM
Brivaracetam Oral Solution	BRIVARACETAM	Ascend Laboratories, LLC	c4ee9b82-1067-4efc-b3d9-f24eb0c461d5	2026-02-24	Warnings, Adverse reactions	Name fallback generic name: BRIVARACETAM
Brivaracetam	BRIVARACETAM	Novadoz Pharmaceuticals LLC	2c6af271-3222-4602-98a6-14754f0a29ba	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: Brivaracetam generic name: BRIVARACETAM
Brivaracetam	BRIVARACETAM	Hainan Poly Pharm. Co., Ltd.	3ea51292-fe03-46f5-9d9b-36986f5b7224	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: Brivaracetam generic name: BRIVARACETAM
brivaracetam	BRIVARACETAM	Zhejiang Poly Pharm. Co., Ltd.	aef3ee92-e2a6-4135-94b2-b893f893d5f2	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: brivaracetam generic name: BRIVARACETAM
Brivaracetam	BRIVARACETAM INJECTION	PAI Holdings, LLC dba PAI Pharma	5bc0f4c0-8b31-4622-849f-d902be93788b	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: Brivaracetam
brivaracetam	BRIVARACETAM	Novadoz Pharmaceuticals LLC	dca92c5b-78a8-4ee1-9f06-18320ae2a2e8	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: brivaracetam generic name: BRIVARACETAM
Brivaracetam	BRIVARACETAM	PAI Holdings, LLC dba PAI Pharma	57627ea9-3b14-4428-ad95-6ea25ecaef31	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: Brivaracetam generic name: BRIVARACETAM
brivaracetam	BRIVARACETAM	Zydus Lifesciences Limited	67c4db20-ba4d-4640-9e9c-6949b85429e3	2026-01-27		Name fallback brand name: brivaracetam generic name: BRIVARACETAM
brivaracetam	BRIVARACETAM	Zydus Pharmaceuticals USA Inc.	d54ca946-2ddf-4a67-87c9-20a814bfd2dc	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: brivaracetam generic name: BRIVARACETAM

Reported adverse events (FAERS/openFDA)#

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