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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 211251

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NDA 211251 describes TRIENTINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Amneal, Chartwell Rx, Dr Reddys, Eci Pharms Llc, Hetero Labs Ltd Iii, Lupin Ltd, MSN, Navinta Llc, Ph Health, Rising, Watson Labs Teva, and Zydus Pharms, and is included in thirteen NDAs. It is available from seven suppliers. Additional details are available on the TRIENTINE HYDROCHLORIDE profile page.

The generic ingredient in TRIENTINE HYDROCHLORIDE is trientine hydrochloride. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the trientine hydrochloride profile page.

Summary for 211251

Tradename:	TRIENTINE HYDROCHLORIDE
Applicant:	Navinta Llc
Ingredient:	trientine hydrochloride
Patents:	0

Pharmacology for NDA: 211251

Mechanism of Action	Copper Chelating Activity Metal Chelating Activity

Medical Subject Heading (MeSH) Categories for 211251

Chelating Agents

Suppliers and Packaging for NDA: 211251

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	211251	ANDA	Navinta LLC	68475-200	68475-200-01	1 BOTTLE in 1 CARTON (68475-200-01) / 100 CAPSULE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Jan 16, 2019	TE:	AB	RLD:	No

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