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Generated: June 26, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211251

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NDA 211251 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 211251
Tradename:TRIENTINE HYDROCHLORIDE
Applicant:Navinta Llc
Ingredient:trientine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211251
Mechanism of ActionMetal Chelating Activity
Medical Subject Heading (MeSH) Categories for 211251
Suppliers and Packaging for NDA: 211251
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIENTINE HYDROCHLORIDE trientine hydrochloride CAPSULE;ORAL 211251 ANDA Lannett Company Inc. 0527-4068 0527-4068-37 1 BOTTLE in 1 CARTON (0527-4068-37) > 100 CAPSULE in 1 BOTTLE
TRIENTINE HYDROCHLORIDE trientine hydrochloride CAPSULE;ORAL 211251 ANDA Navinta LLC 68475-200 68475-200-01 1 BOTTLE in 1 CARTON (68475-200-01) > 100 CAPSULE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Jan 16, 2019TE:ABRLD:No

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