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FDA NDA · NDA210795

KRINTAFEL

tafenoquine succinate

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APPLICATION
NDA210795
TYPE
NDA
ORIGINAL APPROVAL
2018-07-20
LATEST ACTION
2020-11-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

KRINTAFEL · ReferencePrescription
TAFENOQUINE SUCCINATE EQ 150MG BASE · TABLET · ORAL

Approval history

2020-11-16Labeling · Supplement 1 · standard — Label ↗AP
2018-07-20Type 1 - New Molecular Entity · Original · priority — Label ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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