Application 214875

Type: ANDA
Sponsor: APOTEX INC

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 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	Approval date
A214875-001	BRIVARACETAM	BRIVARACETAM	10MG	TABLET / ORAL	AB	2026-02-23
A214875-002	BRIVARACETAM	BRIVARACETAM	25MG	TABLET / ORAL	AB	2026-02-23
A214875-003	BRIVARACETAM	BRIVARACETAM	50MG	TABLET / ORAL	AB	2026-02-23
A214875-004	BRIVARACETAM	BRIVARACETAM	75MG	TABLET / ORAL	AB	2026-02-23
A214875-005	BRIVARACETAM	BRIVARACETAM	100MG	TABLET / ORAL	AB	2026-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214875-001	AB
A214875-002	AB
A214875-003	AB
A214875-004	AB
A214875-005	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214875-001	BRIVARACETAM	10MG	TABLET / ORAL	AB	2026-02-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214875-002	BRIVARACETAM	25MG	TABLET / ORAL	AB	2026-02-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214875-003	BRIVARACETAM	50MG	TABLET / ORAL	AB	2026-02-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214875-004	BRIVARACETAM	75MG	TABLET / ORAL	AB	2026-02-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214875-005	BRIVARACETAM	100MG	TABLET / ORAL	AB	2026-02-23	`a50c72e98297…`

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	A214875-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214875-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214875-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214875-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214875-005	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Brivaracetam	BRIVARACETAM	Apotex Corp.	1915620d-4f37-56c2-437e-8362bb462d07	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214875 application number: ANDA214875

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71958	ORIG	2022-08-30