Application 213369

Type: ANDA
Sponsor: APOTEX

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 43.

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
A213369-001	OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13
A213369-002	OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13
A213369-003	OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213369-001	AB
A213369-002	AB
A213369-003	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 · 66 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
2026-09-14 22:38:34	2026-08	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL		2023-07-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2023-07-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL		2023-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL		2023-07-13	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213369-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213369-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213369-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213369-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213369-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213369-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213369-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213369-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213369-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213369-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213369-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213369-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213369-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213369-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213369-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213369-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213369-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213369-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213369-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213369-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213369-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213369-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213369-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213369-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213369-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213369-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213369-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213369-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213369-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213369-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213369-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213369-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213369-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213369-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213369-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213369-003	AB	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213369-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213369-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213369-003	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 2 of 4 · 72 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxcarbazepine	OXCARBAZEPINE	NCS HealthCare of KY, LLC dba Vangard Labs	a14b5756-4fd1-4ba7-bc23-e1fa9212a148	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Coupler LLC	512ab25c-ea79-1e59-e063-6294a90ae9a0	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Umedica Laboratories USA Inc.	e46d4654-76bc-4c33-ac2b-e89ae11b7697	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Coupler LLC	51008af2-39ac-546c-e063-6294a90a758f	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Major Pharmaceuticals	567c0777-9bc5-45a9-ba25-959dd76d0e05	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Coupler LLC	50873ef7-3deb-7386-e063-6394a90a9c19	2026-04-28	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Bryant Ranch Prepack	87f53c04-075c-4d09-925a-0faeaa14f3f9	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Breckenridge Pharmaceutical, Inc.	54fb494e-bce4-442d-954a-757f9851e81e	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Bryant Ranch Prepack	148b90ba-236a-47cc-b171-22dd7f8f8e0a	2026-03-20	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	NorthStar RxLLC	20d826cd-fa4a-4570-9e10-9d7d10fb725b	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Advagen Pharma Limited	b0bc10f0-7d1b-4adc-bc59-c48dab58ee5a	2026-02-24	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Advagen Pharma Ltd.	ab4c1f36-82fa-40a2-a31a-227875d0f382	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	REMEDYREPACK INC.	244f9a68-5ab4-46b8-a01f-538572fd3c5f	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	REMEDYREPACK INC.	6d2a6cac-f16b-4e6c-8f75-3afffb0a0f3b	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Camber Pharmaceuticals, Inc.	fe49a773-562c-4da6-96b7-bba52f4d61e2	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Advagen Pharma Ltd	4ef6a941-a017-40f2-a50a-ab66c43b3347	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: OXCARBAZEPINE generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Chartwell RX, LLC	c2affa00-1d57-4d85-8db3-745191b4714d	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Coupler LLC	47b92168-6832-1e0b-e063-6394a90a079a	2026-01-06	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Chartwell Governmental & Specialty RX, LLC.	e74bb389-8426-4ffc-a14b-a5990de6d0d4	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Oxcarbazepine generic name: OXCARBAZEPINE
Trileptal	OXCARBAZEPINE	Novartis Pharmaceuticals Corporation	4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b	2025-12-16	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75163	ORIG	2023-08-21