Application 213718

Type: ANDA
Sponsor: AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BREXPIPRAZOLE	BREXPIPRAZOLE	TABLET; ORAL	0.25MG	No	No
002	BREXPIPRAZOLE	BREXPIPRAZOLE	TABLET;ORAL	0.5MG	No	No
003	BREXPIPRAZOLE	BREXPIPRAZOLE	TABLET;ORAL	1MG	No	No
004	BREXPIPRAZOLE	BREXPIPRAZOLE	TABLET;ORAL	2MG	No	No
005	BREXPIPRAZOLE	BREXPIPRAZOLE	TABLET;ORAL	3MG	No	No
006	BREXPIPRAZOLE	BREXPIPRAZOLE	TABLET;ORAL	4MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A213718-001	BREXPIPRAZOLE	BREXPIPRAZOLE	0.25MG	TABLET / ORAL	2023-02-03
A213718-002	BREXPIPRAZOLE	BREXPIPRAZOLE	0.5MG	TABLET / ORAL	2023-02-03
A213718-003	BREXPIPRAZOLE	BREXPIPRAZOLE	1MG	TABLET / ORAL	2023-02-03
A213718-004	BREXPIPRAZOLE	BREXPIPRAZOLE	2MG	TABLET / ORAL	2023-02-03
A213718-005	BREXPIPRAZOLE	BREXPIPRAZOLE	3MG	TABLET / ORAL	2023-02-03
A213718-006	BREXPIPRAZOLE	BREXPIPRAZOLE	4MG	TABLET / ORAL	2023-02-03

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 4 · 138 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213718-001	BREXPIPRAZOLE	0.25MG	TABLET / ORAL	2023-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213718-002	BREXPIPRAZOLE	0.5MG	TABLET / ORAL	2023-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213718-003	BREXPIPRAZOLE	1MG	TABLET / ORAL	2023-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213718-004	BREXPIPRAZOLE	2MG	TABLET / ORAL	2023-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213718-005	BREXPIPRAZOLE	3MG	TABLET / ORAL	2023-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213718-006	BREXPIPRAZOLE	4MG	TABLET / ORAL	2023-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213718-001	BREXPIPRAZOLE	0.25MG	TABLET / ORAL	2023-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213718-002	BREXPIPRAZOLE	0.5MG	TABLET / ORAL	2023-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213718-003	BREXPIPRAZOLE	1MG	TABLET / ORAL	2023-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213718-004	BREXPIPRAZOLE	2MG	TABLET / ORAL	2023-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213718-005	BREXPIPRAZOLE	3MG	TABLET / ORAL	2023-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213718-006	BREXPIPRAZOLE	4MG	TABLET / ORAL	2023-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213718-001	BREXPIPRAZOLE	0.25MG	TABLET / ORAL	2023-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213718-002	BREXPIPRAZOLE	0.5MG	TABLET / ORAL	2023-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213718-003	BREXPIPRAZOLE	1MG	TABLET / ORAL	2023-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213718-004	BREXPIPRAZOLE	2MG	TABLET / ORAL	2023-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213718-005	BREXPIPRAZOLE	3MG	TABLET / ORAL	2023-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213718-006	BREXPIPRAZOLE	4MG	TABLET / ORAL	2023-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213718-001	BREXPIPRAZOLE	0.25MG	TABLET / ORAL	2023-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213718-002	BREXPIPRAZOLE	0.5MG	TABLET / ORAL	2023-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213718-003	BREXPIPRAZOLE	1MG	TABLET / ORAL	2023-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213718-004	BREXPIPRAZOLE	2MG	TABLET / ORAL	2023-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213718-005	BREXPIPRAZOLE	3MG	TABLET / ORAL	2023-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213718-006	BREXPIPRAZOLE	4MG	TABLET / ORAL	2023-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213718-001	BREXPIPRAZOLE	0.25MG	TABLET / ORAL	2023-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213718-002	BREXPIPRAZOLE	0.5MG	TABLET / ORAL	2023-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213718-003	BREXPIPRAZOLE	1MG	TABLET / ORAL	2023-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213718-004	BREXPIPRAZOLE	2MG	TABLET / ORAL	2023-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213718-005	BREXPIPRAZOLE	3MG	TABLET / ORAL	2023-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213718-006	BREXPIPRAZOLE	4MG	TABLET / ORAL	2023-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213718-001	BREXPIPRAZOLE	0.25MG	TABLET / ORAL	2023-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213718-002	BREXPIPRAZOLE	0.5MG	TABLET / ORAL	2023-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213718-003	BREXPIPRAZOLE	1MG	TABLET / ORAL	2023-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213718-004	BREXPIPRAZOLE	2MG	TABLET / ORAL	2023-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213718-005	BREXPIPRAZOLE	3MG	TABLET / ORAL	2023-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213718-006	BREXPIPRAZOLE	4MG	TABLET / ORAL	2023-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213718-001	BREXPIPRAZOLE	0.25MG	TABLET / ORAL	2023-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213718-002	BREXPIPRAZOLE	0.5MG	TABLET / ORAL	2023-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213718-003	BREXPIPRAZOLE	1MG	TABLET / ORAL	2023-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213718-004	BREXPIPRAZOLE	2MG	TABLET / ORAL	2023-02-03	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213718-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213718-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213718-003	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213718-004	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213718-005	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213718-006	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213718-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213718-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213718-003	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213718-004	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213718-005	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213718-006	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213718-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213718-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213718-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213718-004	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213718-005	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213718-006	AB	1	`053a50430f4f…`

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
Brexpiprazole	BREXPIPRAZOLE	Ajanta Pharma USA Inc.	993b584c-7fe6-4551-899f-39146c8508ac	2022-12-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213718 application number: ANDA213718

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68530	ORIG	2021-09-02