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Generated: June 27, 2019

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Details for New Drug Application (NDA): 207567

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NDA 207567 describes TRIENTINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms Llc, Msn Labs Pvt Ltd, Navinta Llc, Watson Labs Teva, and Zydus Pharms, and is included in five NDAs. It is available from nine 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. Eleven suppliers are listed for this compound. Additional details are available on the trientine hydrochloride profile page.
Summary for 207567
Tradename:TRIENTINE HYDROCHLORIDE
Applicant:Watson Labs Teva
Ingredient:trientine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207567
Mechanism of ActionMetal Chelating Activity
Medical Subject Heading (MeSH) Categories for 207567
Suppliers and Packaging for NDA: 207567
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIENTINE HYDROCHLORIDE trientine hydrochloride CAPSULE;ORAL 207567 ANDA Actavis Pharma, Inc. 0591-4910 0591-4910-01 100 CAPSULE in 1 BOTTLE (0591-4910-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Feb 7, 2018TE:ABRLD:No

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