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TRIENTINE HYDROCHLORIDE

ANDA

TRIENTINE HYDROCHLORIDE | A207567 | WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain9 active DMFs2 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

CHEMWERTH INCTRIENTINE HYDROCHLORIDE USP

DMF 290192015

TAPI NL BVTRIENTINE HYDROCHLORIDE USP

DMF 290852015

BIOPHORE INDIA PHARMACEUTICALS PVT LTDTRIENTINE HYDROCHLORIDE

DMF 295272015

SS PHARMA LLCTRIENTINE HYDROCHLORIDE USP

DMF 308782016

NAVINTA LLCTRIENTINE HYDROCHLORIDE USP

DMF 309052016

MSN ORGANICS PRIVATE LTDTRIENTINE HYDROCHLORIDE USP

DMF 310852016

EMCURE PHARMACEUTICALS LTDTRIENTINE HYDROCHLORIDE USP

DMF 313952017

COHANCE LIFESCIENCES LTDTRIENTINE HYDROCHLORIDE

DMF 329562018

DASAMI LAB PRIVATE LTDTRIENTINE HYDROCHLORIDE

DMF 349102020

TIANISH LABORATORIES PRIVATE LTDInactiveTRIENTINE HYDROCHLORIDE USP

DMF 321132017

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDInactiveTRIENTINE HYDROCHLORIDE USP

DMF 377772022

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 5, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Feb 7, 2018

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

Watson Labs Teva's Trientine Hydrochloride (NDA 207567) transitioned from prescription to discontinued status.

Old: RX

New: DISCN

MODIFIEDTE Code7/1/2026

Watson Labs Teva's Trientine Hydrochloride (NDA 207567) therapeutic equivalence rating changed from AB to a different code.

Old: AB