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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 211637

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NDA 211637 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 211637

Tradename:	TRIENTINE HYDROCHLORIDE
Applicant:	Lupin Ltd
Ingredient:	trientine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 211637

Chelating Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	May 21, 2020	TE:		RLD:	No

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