Application 215939

Type: ANDA
Sponsor: ANNORA PHARMA

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 42.

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
A215939-001	OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11
A215939-002	OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11
A215939-003	OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215939-001	AB
A215939-002	AB
A215939-003	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 3 · 99 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
2026-08-18 06:07:40	2026-07	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215939-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215939-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215939-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215939-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215939-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215939-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215939-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215939-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215939-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215939-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215939-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215939-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215939-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215939-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215939-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215939-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215939-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215939-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215939-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215939-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215939-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215939-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215939-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215939-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215939-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215939-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215939-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215939-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215939-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215939-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215939-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215939-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215939-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215939-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215939-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215939-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215939-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215939-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215939-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215939-001	AB	1	`1e350fbaab3a…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxcarbazepine	OXCARBAZEPINE	Cardinal Health 107, LLC	3e0f8d9f-7659-4524-8f93-6200314356c8	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	American Health Packaging	c0f9df3f-280e-4394-8d7e-ad04803b2635	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939 ndc (product): 60687-711 ndc (product): 60687-722 ndc (product): 60687-733
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	c7718f8b-63e2-40b9-b519-e687cfc2cacf	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	188a48ad-c412-416a-b15b-de5f232740a2	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	0abe9478-4084-286d-e063-6294a90a9ba7	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	ASCLEMED USA INC.	c42b2cb2-8b45-488b-bf63-81909a1f06cb	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	Coupler LLC	512ab25c-ea79-1e59-e063-6294a90ae9a0	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	NCS HealthCare of KY, LLC dba Vangard Labs	3fb47782-3dfc-458c-92a6-493de1207c0e	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
OXCARBAZEPINE	OXCARBAZEPINE	NorthStar RxLLC	20d826cd-fa4a-4570-9e10-9d7d10fb725b	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	Camber Pharmaceuticals, Inc.	fe49a773-562c-4da6-96b7-bba52f4d61e2	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939 ndc (product): 31722-023 ndc (product): 31722-024 ndc (product): 31722-025
Oxcarbazepine	OXCARBAZEPINE	Proficient Rx LP	433d9d03-a36e-42c6-8e4d-f333ed60e45a	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	Bryant Ranch Prepack	23137a89-cbd0-4a5f-8220-f26b7ba54330	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	AvPAK	fd8da0e9-d69b-7587-e053-6294a90a33c0	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	XLCare Pharmaceuticals Inc.	9f5d17e4-ca68-48e2-9e87-d3ab1c59aa93	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-023	Oxcarbazepine	Oxcarbazepine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-023	Oxcarbazepine	Oxcarbazepine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-024	Oxcarbazepine	Oxcarbazepine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-024	Oxcarbazepine	Oxcarbazepine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-025	Oxcarbazepine	Oxcarbazepine	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-025	Oxcarbazepine	Oxcarbazepine	Camber Pharmaceuticals, Inc.	ANDA	Current
60687-711	Oxcarbazepine	Oxcarbazepine	American Health Packaging	ANDA	Current
60687-711	Oxcarbazepine	Oxcarbazepine	American Health Packaging	ANDA	Current
60687-722	Oxcarbazepine	Oxcarbazepine	American Health Packaging	ANDA	Current
60687-722	Oxcarbazepine	Oxcarbazepine	American Health Packaging	ANDA	Current
60687-733	Oxcarbazepine	Oxcarbazepine	American Health Packaging	ANDA	Current
60687-733	Oxcarbazepine	Oxcarbazepine	American Health Packaging	ANDA	Current