Application 075712

Type: ANDA
Sponsor: TORRENT PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBAMAZEPINE	CARBAMAZEPINE	TABLET, CHEWABLE;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075712-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2001-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075712-001	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 · 42 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	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A075712-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075712-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075712-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075712-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075712-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075712-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075712-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075712-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075712-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075712-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075712-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075712-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075712-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075712-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075712-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075712-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075712-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075712-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075712-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075712-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075712-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075712-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075712-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075712-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075712-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075712-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075712-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075712-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075712-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075712-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075712-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075712-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075712-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075712-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075712-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075712-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075712-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075712-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075712-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075712-001	AB	1	`e64feba35796…`

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 · 5 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): 075712 application number: ANDA075712 ndc (product): 13668-271
CARBAMAZEPINE	CARBAMAZEPINE	Major Pharmaceuticals	2a8c7366-ce89-47ce-8123-96f26812fca0	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075712 application number: ANDA075712 ndc (product): 0904-3854
CARBAMAZEPINE	CARBAMAZEPINE	Coupler LLC	5461e739-0f18-b012-e063-6394a90a6b14	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075712 application number: ANDA075712
CARBAMAZEPINE	CARBAMAZEPINE	Bryant Ranch Prepack	c72a0668-7cd7-46a8-86d1-d3c17c4b900f	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075712 application number: ANDA075712
Carbamazepine	CARBAMAZEPINE	American Health Packaging	f8444c23-a74f-4d44-867e-26554dbb882f	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075712 application number: ANDA075712 ndc (product): 60687-479

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-3854	CARBAMAZEPINE	CARBAMAZEPINE	Major Pharmaceuticals	ANDA	Current
0904-3854	CARBAMAZEPINE	CARBAMAZEPINE	Major Pharmaceuticals	ANDA	Current
0904-3854	CARBAMAZEPINE	CARBAMAZEPINE	Major Pharmaceuticals	ANDA	Current
0904-3854	CARBAMAZEPINE	CARBAMAZEPINE	Major Pharmaceuticals	ANDA	Current
13668-271	CARBAMAZEPINE	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-271	CARBAMAZEPINE	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-271	CARBAMAZEPINE	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-271	CARBAMAZEPINE	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-271	CARBAMAZEPINE	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	ANDA	Current
53808-0858	CARBAMAZEPINE	CARBAMAZEPINE	State of Florida DOH Central Pharmacy	ANDA	Current
60687-479	Carbamazepine	Carbamazepine	American Health Packaging	ANDA	Current
60687-479	Carbamazepine	Carbamazepine	American Health Packaging	ANDA	Current
60687-479	Carbamazepine	Carbamazepine	American Health Packaging	ANDA	Current
63629-8255	CARBAMAZEPINE	CARBAMAZEPINE	Bryant Ranch Prepack	ANDA	Current
63629-8255	CARBAMAZEPINE	CARBAMAZEPINE	Bryant Ranch Prepack	ANDA	Current
63629-8255	CARBAMAZEPINE	CARBAMAZEPINE	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24155	ORIG	2008-02-01