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Generated: November 21, 2018

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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. Additional details are available on the KRINTAFEL profile page.

The generic ingredient in KRINTAFEL is tafenoquine succinate. One supplier is 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

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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