Application 217659

Type: ANDA
Sponsor: AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXCARBAZEPINE	OXCARBAZEPINE	TABLET, EXTENDED RELEASE;ORAL	150MG	No	No
002	OXCARBAZEPINE	OXCARBAZEPINE	TABLET, EXTENDED RELEASE;ORAL	300MG	No	No
003	OXCARBAZEPINE	OXCARBAZEPINE	TABLET, EXTENDED RELEASE;ORAL	600MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A217659-001	OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22
A217659-002	OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22
A217659-003	OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A217659-001	AB
A217659-002	AB
A217659-003	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 · 48 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
2026-02-19 14:30 UTC	2026-02	A217659-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217659-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217659-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217659-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217659-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217659-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217659-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217659-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217659-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217659-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217659-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217659-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217659-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217659-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217659-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217659-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217659-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217659-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217659-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217659-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217659-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217659-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217659-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217659-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217659-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217659-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217659-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217659-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217659-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217659-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL		2024-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217659-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217659-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217659-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217659-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217659-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217659-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217659-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217659-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217659-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217659-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-22	`8072bd15b7f6…`

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	A217659-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217659-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217659-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217659-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217659-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217659-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217659-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217659-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217659-003	AB	1	`6a471c1ec25d…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217659-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217659-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217659-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217659-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217659-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217659-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217659-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217659-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217659-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217659-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217659-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217659-003	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217659-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217659-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217659-003	AB	1	`6a51e52b5d6a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217659-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217659-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217659-003	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
Oxcarbazepine	OXCARBAZEPINE	Ajanta Pharma USA Inc.	d947e9b1-2a15-4048-bb4e-fe56b6851848	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217659 application number: ANDA217659