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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210795

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NDA 210795 describes KRINTAFEL, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. Additional details are available on the KRINTAFEL profile page.

The generic ingredient in KRINTAFEL is tafenoquine succinate. Two suppliers are listed for this compound. Additional details are available on the tafenoquine succinate profile page.
Summary for 210795
Tradename:KRINTAFEL
Applicant:Glaxosmithkline
Ingredient:tafenoquine succinate
Patents:0
Suppliers and Packaging for NDA: 210795
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KRINTAFEL tafenoquine succinate TABLET;ORAL 210795 NDA GlaxoSmithKline LLC 0173-0889 0173-0889-13 30 TABLET, FILM COATED in 1 BOTTLE (0173-0889-13)
KRINTAFEL tafenoquine succinate TABLET;ORAL 210795 NDA GlaxoSmithKline LLC 0173-0889 0173-0889-39 2 TABLET, FILM COATED in 1 BOTTLE (0173-0889-39)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Jul 20, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 20, 2025
Regulatory Exclusivity Use:INDICATED FOR THE RADICAL CURE (PREVENTION OF RELAPSE) OF PLASMODIUM VIVAX MALARIA IN PATIENTS AGED 16 YEARS AND OLDER WHO ARE RECEIVING APPROPRIATE ANTIMALARIAL THERAPY FOR ACUTE P. VIVAX INFECTION
Regulatory Exclusivity Expiration:Jul 20, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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