NDA 210795, held by Glaxosmithkline. Tafenoquine Succinate.
As of Nov 13, 2026, NDA 210795 (Krintafel), held by Glaxosmithkline, was first approved by FDA on Jul 20, 2018, with 1 approved supplement and 0 published complete response letters.
KRINTAFEL is indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving chloroquine therapy for acute P. vivax infection. Limitations of Use
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 20, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| KrintafelEQ 150MG BASE · tablet;oral | Tafenoquine Succinate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 16, 2020 | Supplement 1Labeling · Standard review | Approved | |
| Jul 20, 2018 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
