Application 078592

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBAMAZEPINE	CARBAMAZEPINE	CAPSULE, EXTENDED RELEASE;ORAL	100MG	No	No
002	CARBAMAZEPINE	CARBAMAZEPINE	CAPSULE, EXTENDED RELEASE;ORAL	200MG	No	No
003	CARBAMAZEPINE	CARBAMAZEPINE	CAPSULE, EXTENDED RELEASE;ORAL	300MG	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
A078592-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20
A078592-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20
A078592-003	CARBAMAZEPINE	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078592-001	AB
A078592-002	AB
A078592-003	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 · 129 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	A078592-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078592-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078592-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078592-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078592-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078592-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078592-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078592-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078592-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078592-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078592-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078592-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078592-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078592-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078592-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078592-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078592-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078592-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078592-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078592-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078592-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078592-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078592-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078592-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078592-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078592-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078592-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078592-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078592-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078592-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078592-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078592-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078592-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078592-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078592-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078592-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078592-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078592-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078592-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078592-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-09-20	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078592-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078592-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078592-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078592-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078592-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078592-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078592-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078592-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078592-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078592-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078592-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078592-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078592-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078592-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078592-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078592-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078592-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078592-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078592-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078592-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078592-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078592-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078592-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078592-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078592-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078592-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078592-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078592-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078592-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078592-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078592-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078592-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078592-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078592-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078592-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078592-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078592-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078592-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078592-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078592-001	AB	1	`301d65b070ca…`

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 3 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARBAMAZEPINE	CARBAMAZEPINE	Preferred Pharmaceuticals Inc.	32dc301e-881d-47b0-ad16-f9ff31d19324	2026-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Northstar Rx LLC	b563e4a1-d7dd-4901-ad45-614f85687589	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Golden State Medical Supply, Inc.	536811ab-308b-4866-9185-9e4149483512	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Golden State Medical Supply, Inc.	1922a7cd-6a43-dab5-e063-6294a90a3d8f	2026-02-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Golden State Medical Supply, Inc.	8a1ce79d-18ea-f30b-e053-2995a90ad1fb	2026-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	47d0ea82-9974-4d41-9ae1-5f1b11419a33	2026-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	ANI Pharmaceuticals, Inc.	e006049f-1c0c-4544-969e-0344d1b8c5ba	2026-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine ER	CARBAMAZEPINE	Epic Pharma, LLC	46a9771e-5830-4905-b5fc-5d1c61fd56a0	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	AvPAK	ceb84aa4-2041-6e6e-e053-2995a90a0f24	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Rising Pharma Holdings, Inc.	bf1590a0-68a7-45ed-817e-f97366f96ec4	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	NIVAGEN PHARMACEUTICALS, INC.	e68998cb-5f91-4d7e-85a6-555efb8b0384	2025-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	American Health Packaging	f8444c23-a74f-4d44-867e-26554dbb882f	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	Golden State Medical Supply, Inc.	9fca7d59-dd9e-4fd8-bf34-e2f7e5a36801	2025-11-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	d684dfd8-1e0d-47a1-bf37-ada6413815f2	2025-11-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	0ccee1ed-3d7c-452b-9519-c1ddb92893df	2025-11-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Alembic Pharmaceuticals Inc.	726a127b-03b2-44e8-a63d-078b35e27525	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	1a8c4f15-9e75-4919-ac67-06102b82dd92	2025-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Chartwell Governmental & Specialty RX, LLC.	35298eaf-3478-4dfb-a629-298dd52713f0	2025-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
Carbamazepine	CARBAMAZEPINE	Ingenus Pharmaceuticals, LLC	de67de85-15b3-4c27-b604-d028ce3789d0	2025-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Carbamazepine generic name: CARBAMAZEPINE
CARBAMAZEPINE	CARBAMAZEPINE	AvPAK	41157f3e-61c4-1cbd-e063-6294a90a219f	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CARBAMAZEPINE generic name: CARBAMAZEPINE

Reported adverse events (FAERS/openFDA)#

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