Application 077272

Type: ANDA
Sponsor: TORRENT PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBAMAZEPINE	CARBAMAZEPINE	TABLET;ORAL	100MG	No	No
002	CARBAMAZEPINE	CARBAMAZEPINE	TABLET;ORAL	200MG	No	No
003	CARBAMAZEPINE	CARBAMAZEPINE	TABLET;ORAL	300MG	No	No
004	CARBAMAZEPINE	CARBAMAZEPINE	TABLET;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077272-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07
A077272-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07
A077272-003	CARBAMAZEPINE	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07
A077272-004	CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077272-002	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 5 · 172 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	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2005-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2005-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 73 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A077272-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077272-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077272-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077272-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077272-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077272-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077272-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077272-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077272-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077272-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077272-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077272-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077272-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077272-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077272-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077272-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077272-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077272-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077272-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077272-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077272-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077272-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077272-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077272-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077272-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077272-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077272-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077272-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077272-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A077272-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077272-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077272-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077272-002	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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARBAMAZEPINE	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	97e6e175-75e8-437b-b457-ddb1ae4e857d	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077272 application number: ANDA077272 ndc (product): 13668-268
Carbamazepine	CARBAMAZEPINE	Cardinal Health 107, LLC	232ef732-ee6d-4ac7-8e78-c619b611fbbe	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077272 application number: ANDA077272 ndc (product): 55154-1396

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-4515	CARBAMAZEPINE	CARBAMAZEPINE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6172	CARBAMAZEPINE	CARBAMAZEPINE	Major Pharmaceuticals	ANDA	Current
0904-6172	CARBAMAZEPINE	CARBAMAZEPINE	Major Pharmaceuticals	ANDA	Current
0904-6172	CARBAMAZEPINE	CARBAMAZEPINE	Major Pharmaceuticals	ANDA	Current
0904-6172	CARBAMAZEPINE	CARBAMAZEPINE	Major Pharmaceuticals	ANDA	Current
13668-268	CARBAMAZEPINE	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-268	CARBAMAZEPINE	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-268	CARBAMAZEPINE	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-268	CARBAMAZEPINE	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-268	CARBAMAZEPINE	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	ANDA	Current
49999-616	CARBAMAZEPINE	CARBAMAZEPINE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55154-1396	Carbamazepine	Carbamazepine	Cardinal Health	ANDA	Current
55154-1396	Carbamazepine	Carbamazepine	Cardinal Health 107, LLC	ANDA	Current
55154-1396	Carbamazepine	Carbamazepine	Cardinal Health	ANDA	Current
58118-0268	CARBAMAZEPINE	CARBAMAZEPINE	Clinical Solutions Wholesale	ANDA	Current
58118-0268	CARBAMAZEPINE	CARBAMAZEPINE	Clinical Solutions Wholesale	ANDA	Current
58118-0268	CARBAMAZEPINE	CARBAMAZEPINE	Clinical Solutions Wholesale	ANDA	Current
60687-490	Carbamazepine	Carbamazepine	American Health Packaging	ANDA	Current
66267-278	CARBAMAZEPINE	CARBAMAZEPINE	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-278	CARBAMAZEPINE	CARBAMAZEPINE	NuCare Pharmaceuticals, Inc.	ANDA	Current
67046-096	CARBAMAZEPINE	CARBAMAZEPINE	Contract Pharmacy Services-PA	ANDA	Current
68788-9492	CARBAMAZEPINE	CARBAMAZEPINE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9492	CARBAMAZEPINE	CARBAMAZEPINE	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0902	CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	ANDA	Current
70518-0902	CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	ANDA	Current
70518-0902	CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	ANDA	Current
70518-0902	CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	ANDA	Current
70518-0902	CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	ANDA	Current
70518-0902	CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	ANDA	Current
70518-2456	CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	ANDA	Current
70518-2456	CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	ANDA	Current
70518-2456	CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	ANDA	Current
70518-2456	CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	ANDA	Current
70518-2489	CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	ANDA	Current
70518-2489	CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	ANDA	Current
70518-2489	CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	ANDA	Current
70518-2489	CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	ANDA	Current
70518-2489	CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	ANDA	Current
71335-0462	CARBAMAZEPINE	CARBAMAZEPINE	Bryant Ranch Prepack	ANDA	Current
71335-0462	CARBAMAZEPINE	CARBAMAZEPINE	Bryant Ranch Prepack	ANDA	Current
71335-0462	CARBAMAZEPINE	CARBAMAZEPINE	Bryant Ranch Prepack	ANDA	Current
71335-0462	CARBAMAZEPINE	CARBAMAZEPINE	Bryant Ranch Prepack	ANDA	Current
71335-0462	CARBAMAZEPINE	CARBAMAZEPINE	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44618	ORIG	2008-02-01