Application 076570

Type: ANDA
Sponsor: SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIMETHOBENZAMIDE HYDROCHLORIDE	TRIMETHOBENZAMIDE HYDROCHLORIDE	CAPSULE;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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL			2003-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2003-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2003-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2003-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2003-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2003-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2003-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2003-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2003-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076570-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2003-08-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076570-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076570-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076570-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076570-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076570-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076570-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076570-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076570-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076570-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076570-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076570-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076570-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076570-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076570-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076570-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076570-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076570-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076570-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076570-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076570-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076570-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076570-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076570-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076570-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076570-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076570-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076570-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076570-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076570-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076570-001	AB	1	`cb3db0bc1861…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trimethobenzamide Hydrochloride	TRIMETHOBENZAMIDE HYDROCHLORIDE	BPI Labs, LLC	a9a661ca-87ca-4c96-88ef-58fcaae233b5	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Trimethobenzamide Hydrochloride generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE
Tigan	TRIMETHOBENZAMIDE HYDROCHLORIDE	Par Health USA, LLC	7da90678-b229-4ad6-9193-2b8a3e9ba695	2026-03-10	Warnings, Adverse reactions	Name fallback generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE
Trimethobenzamide Hydrochloride	TRIMETHOBENZAMIDE HYDROCHLORIDE	Chartwell RX, LLC	ee626da9-cffc-4bb9-a528-482687201b2a	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Trimethobenzamide Hydrochloride generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE
Tigan	TRIMETHOBENZAMIDE HYDROCHLORIDE	Henry Schein, Inc	147def93-cd3d-4e42-89ad-6a6b413bf362	2025-10-14	Warnings, Adverse reactions	Name fallback generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE
Trimethobenzamide Hydrochloride	TRIMETHOBENZAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	00ba5395-1455-4ea9-9278-e3749979526c	2024-04-04	Warnings, Adverse reactions	Name fallback brand name: Trimethobenzamide Hydrochloride generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE
Trimethobenzamide Hydrochloride	TRIMETHOBENZAMIDE HYDROCHLORIDE	Lupin Pharmaceuticals,Inc.	c18073be-d52a-4347-a8d1-6be11bcb7824	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: Trimethobenzamide Hydrochloride generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE
Trimethobenzamide Hydrochloride	TRIMETHOBENZAMIDE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b0aa9b7e-bbe7-482e-81d3-d9658d5ac21f	2023-11-21	Warnings, Adverse reactions	Name fallback brand name: Trimethobenzamide Hydrochloride generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-448	Trimethobenzamide Hydrochloride	Trimethobenzamide	Rebel Distributors Corp.	ANDA	Current
53489-376	Trimethobenzamide Hydrochloride	Trimethobenzamide Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63629-3685	Trimethobenzamide Hydrochloride	Trimethobenzamide Hydrochloride	Bryant Ranch Prepack	ANDA	Current