Application 209945

Type: ANDA
Sponsor: ECI PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIENTINE HYDROCHLORIDE	TRIENTINE HYDROCHLORIDE	CAPSULE;ORAL	250MG	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
A209945-001	TRIENTINE HYDROCHLORIDE	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2021-08-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209945-001	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.

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	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209945-001	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2021-08-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209945-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209945-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209945-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209945-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209945-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209945-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209945-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209945-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209945-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209945-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209945-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209945-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209945-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209945-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209945-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209945-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209945-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209945-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209945-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209945-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209945-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209945-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209945-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209945-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209945-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209945-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209945-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209945-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209945-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209945-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209945-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209945-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209945-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trientine Hydrochloride	TRIENTINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	f33c1322-f7c0-4684-afc8-8caa3f4023dc	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Trientine Hydrochloride generic name: TRIENTINE HYDROCHLORIDE
Trientine Hydrochloride	TRIENTINE HYDROCHLORIDE	Navinta LLC	4c9233bd-be3d-46f0-8fa9-a17e61b1b9a8	2025-02-25	Warnings, Adverse reactions	Name fallback brand name: Trientine Hydrochloride generic name: TRIENTINE HYDROCHLORIDE
Trientine Hydrochloride	TRIENTINE HYDROCHLORIDE	Dr.Reddys Laboratories Inc	fff41159-af99-94bf-4327-8a6a7ee77b36	2024-12-19	Warnings, Adverse reactions	Name fallback brand name: Trientine Hydrochloride generic name: TRIENTINE HYDROCHLORIDE
Trientine Hydrochloride	TRIENTINE HYDROCHLORIDE	Par Health USA, LLC	431c7f66-d58b-4eb0-b195-d164788f9acf	2024-11-29	Warnings, Adverse reactions	Name fallback brand name: Trientine Hydrochloride generic name: TRIENTINE HYDROCHLORIDE
TRIENTINE HYDROCHLORIDE	TRIENTINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	5240e3de-54b6-4f22-9142-776f0e9ea1d9	2022-08-02	Warnings, Adverse reactions	Name fallback brand name: TRIENTINE HYDROCHLORIDE generic name: TRIENTINE HYDROCHLORIDE
Trientine hydrochloride	TRIENTINE HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	6bc468ca-07ef-4965-b502-0330b76455a0	2022-06-15	Warnings, Adverse reactions	Name fallback brand name: Trientine hydrochloride generic name: TRIENTINE HYDROCHLORIDE
Syprine	TRIENTINE HYDROCHLORIDE	Bausch Health US LLC	c34f77a7-996b-4470-b5df-d946a7fe5dbe	2020-09-01	Warnings, Adverse reactions	Name fallback generic name: TRIENTINE HYDROCHLORIDE