Application 078986

Type: ANDA
Sponsor: APOTEX INC

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 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
A078986-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25
A078986-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25
A078986-003	CARBAMAZEPINE	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078986-001	AB
A078986-002	AB
A078986-003	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	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078986-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078986-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078986-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-11-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A078986-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078986-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078986-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078986-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078986-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078986-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078986-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078986-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078986-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078986-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078986-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078986-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078986-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078986-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078986-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078986-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078986-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078986-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078986-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078986-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078986-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078986-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078986-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078986-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078986-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078986-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078986-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078986-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078986-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078986-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078986-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078986-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078986-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078986-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078986-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078986-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078986-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078986-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078986-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078986-001	AB	1	`8072bd15b7f6…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbamazepine	CARBAMAZEPINE	Major Pharmaceuticals	2676f950-48b4-4bef-a792-ea4570de9aa6	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986 ndc (product): 0904-6885
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	47d0ea82-9974-4d41-9ae1-5f1b11419a33	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986
Carbamazepine	CARBAMAZEPINE	AvPAK	ceb84aa4-2041-6e6e-e053-2995a90a0f24	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986 ndc (product): 50268-171 ndc (product): 50268-170 ndc (product): 50268-172
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	d684dfd8-1e0d-47a1-bf37-ada6413815f2	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	0ccee1ed-3d7c-452b-9519-c1ddb92893df	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	1a8c4f15-9e75-4919-ac67-06102b82dd92	2025-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	e9d282f0-8bb7-4280-b83d-b70d83a04b93	2025-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986
Carbamazepine	CARBAMAZEPINE	Apotex Corp.	e91f9de3-3fdd-0a6b-71ce-53a2cc142816	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986 ndc (product): 60505-2807 ndc (product): 60505-2805 ndc (product): 60505-2806
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	46eef194-760d-43ea-86c5-341927277c91	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	4db57051-13bb-4038-ae58-e4d7f541450d	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	34f75728-b9e8-48e7-e063-6394a90afc31	2025-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078986 application number: ANDA078986

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6885	Carbamazepine	Carbamazepine	Major Pharmaceuticals	ANDA	Current
0904-6885	Carbamazepine	Carbamazepine	Major Pharmaceuticals	ANDA	Current
50268-170	Carbamazepine	Carbamazepine	AvPAK	ANDA	Current
50268-170	Carbamazepine	Carbamazepine	AvPAK	ANDA	Current
50268-171	Carbamazepine	Carbamazepine	AvPAK	ANDA	Current
50268-171	Carbamazepine	Carbamazepine	AvPAK	ANDA	Current
50268-172	Carbamazepine	Carbamazepine	AvPAK	ANDA	Current
50268-172	Carbamazepine	Carbamazepine	AvPAK	ANDA	Current
60505-2805	Carbamazepine	Carbamazepine	Apotex Corp.	ANDA	Current
60505-2805	Carbamazepine	Carbamazepine	Apotex Corp.	ANDA	Current
60505-2805	Carbamazepine	Carbamazepine	Apotex Corp.	ANDA	Current
60505-2805	Carbamazepine	Carbamazepine	Apotex Corp.	ANDA	Current
60505-2806	Carbamazepine	Carbamazepine	Apotex Corp.	ANDA	Current
60505-2806	Carbamazepine	Carbamazepine	Apotex Corp.	ANDA	Current
60505-2806	Carbamazepine	Carbamazepine	Apotex Corp.	ANDA	Current
60505-2806	Carbamazepine	Carbamazepine	Apotex Corp.	ANDA	Current
60505-2807	Carbamazepine	Carbamazepine	Apotex Corp.	ANDA	Current
60505-2807	Carbamazepine	Carbamazepine	Apotex Corp.	ANDA	Current
60505-2807	Carbamazepine	Carbamazepine	Apotex Corp.	ANDA	Current
60505-2807	Carbamazepine	Carbamazepine	Apotex Corp.	ANDA	Current
63629-8720	Carbamazepine	Carbamazepine	Bryant Ranch Prepack	ANDA	Current
63629-8720	Carbamazepine	Carbamazepine	Bryant Ranch Prepack	ANDA	Current
63629-8720	Carbamazepine	Carbamazepine	Bryant Ranch Prepack	ANDA	Current
63629-8721	Carbamazepine	Carbamazepine	Bryant Ranch Prepack	ANDA	Current
63629-8721	Carbamazepine	Carbamazepine	Bryant Ranch Prepack	ANDA	Current
63629-8721	Carbamazepine	Carbamazepine	Bryant Ranch Prepack	ANDA	Current
70518-3176	Carbamazepine	Carbamazepine	REMEDYREPACK INC.	ANDA	Current