Application 078005

Type: ANDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXCARBAZEPINE	OXCARBAZEPINE	TABLET;ORAL	150MG	No	No
002	OXCARBAZEPINE	OXCARBAZEPINE	TABLET;ORAL	300MG	No	No
003	OXCARBAZEPINE	OXCARBAZEPINE	TABLET;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
A078005-001	OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-12-11
A078005-002	OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-12-11
A078005-003	OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078005-001	AB
A078005-002	AB
A078005-003	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 4 · 123 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	A078005-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078005-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078005-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078005-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078005-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078005-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078005-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078005-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078005-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078005-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078005-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078005-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078005-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078005-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078005-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078005-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078005-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078005-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078005-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078005-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078005-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078005-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078005-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078005-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078005-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078005-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078005-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078005-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078005-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078005-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078005-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078005-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078005-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078005-001	OXCARBAZEPINE	150MG	TABLET / ORAL		2007-12-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078005-002	OXCARBAZEPINE	300MG	TABLET / ORAL		2007-12-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078005-003	OXCARBAZEPINE	600MG	TABLET / ORAL		2007-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078005-001	OXCARBAZEPINE	150MG	TABLET / ORAL		2007-12-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078005-002	OXCARBAZEPINE	300MG	TABLET / ORAL		2007-12-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078005-003	OXCARBAZEPINE	600MG	TABLET / ORAL		2007-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078005-001	OXCARBAZEPINE	150MG	TABLET / ORAL		2007-12-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078005-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078005-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078005-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078005-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078005-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078005-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078005-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078005-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078005-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078005-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078005-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078005-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078005-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078005-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078005-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078005-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078005-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078005-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078005-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078005-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078005-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078005-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078005-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078005-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078005-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078005-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078005-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078005-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078005-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078005-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078005-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078005-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078005-003	AB	1	`79d66fd596c7…`
2019-12-13 00:20 UTC	2019-12	A078005-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078005-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078005-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078005-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078005-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078005-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078005-001	AB	1	`b00525d2431f…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxcarbazepine	OXCARBAZEPINE	ANI Pharmaceuticals, Inc.	867eaf99-3e31-4f75-bfae-2898804d956d	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078005 application number: ANDA078005
Oxcarbazepine	OXCARBAZEPINE	NCS HealthCare of KY, LLC dba Vangard Labs	a14b5756-4fd1-4ba7-bc23-e1fa9212a148	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078005 application number: ANDA078005
Oxcarbazepine	OXCARBAZEPINE	Coupler LLC	47b92168-6832-1e0b-e063-6394a90a079a	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078005 application number: ANDA078005

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22616	ORIG	2011-02-15
24171	ORIG	2007-12-21