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Last Updated: January 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211554

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NDA 211554 describes TRIENTINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms Llc, Dr Reddys Labs Ltd, Kadmon Pharms Llc, Msn Labs Pvt Ltd, Navinta Llc, Par Pharm Inc, Watson Labs Teva, and Zydus Pharms, and is included in eight NDAs. It is available from eleven 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. Thirteen suppliers are listed for this compound. Additional details are available on the trientine hydrochloride profile page.
Summary for 211554
Tradename:TRIENTINE HYDROCHLORIDE
Applicant:Zydus Pharms
Ingredient:trientine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211554
Mechanism of ActionMetal Chelating Activity
Medical Subject Heading (MeSH) Categories for 211554
Suppliers and Packaging for NDA: 211554
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIENTINE HYDROCHLORIDE trientine hydrochloride CAPSULE;ORAL 211554 ANDA Zydus Pharmaceuticals (USA) Inc. 70710-1203 70710-1203-1 1 BOTTLE in 1 CARTON (70710-1203-1) > 100 CAPSULE in 1 BOTTLE
TRIENTINE HYDROCHLORIDE trientine hydrochloride CAPSULE;ORAL 211554 ANDA Cadila Healthcare Limited 70771-1438 70771-1438-1 1 BOTTLE in 1 CARTON (70771-1438-1) > 100 CAPSULE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Apr 26, 2019TE:ABRLD:No

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