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Last Updated: December 8, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210619

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NDA 210619 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 twelve 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. Fourteen suppliers are listed for this compound. Additional details are available on the trientine hydrochloride profile page.
Summary for 210619
Applicant:Amneal Pharms Llc
Ingredient:trientine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 210619
Mechanism of ActionMetal Chelating Activity
Medical Subject Heading (MeSH) Categories for 210619
Suppliers and Packaging for NDA: 210619
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIENTINE HYDROCHLORIDE trientine hydrochloride CAPSULE;ORAL 210619 ANDA Bluepharma - Industria Farmaceutica, S.A. 43986-008 43986-008-01 1 BOTTLE, PLASTIC in 1 CARTON (43986-008-01) > 100 CAPSULE in 1 BOTTLE, PLASTIC
TRIENTINE HYDROCHLORIDE trientine hydrochloride CAPSULE;ORAL 210619 ANDA Amneal Pharmaceuticals NY LLC 69238-1545 69238-1545-1 100 CAPSULE, GELATIN COATED in 1 BOTTLE (69238-1545-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Feb 8, 2019TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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