Prevents malaria. NDA 210607, held by 60 Degrees Pharms. Tafenoquine Succinate.
As of Nov 13, 2026, NDA 210607 (Arakoda), held by 60 Degrees Pharms, was first approved by FDA on Aug 8, 2018, with 1 approved supplement and 0 published complete response letters.
ARAKODA is indicated for the prophylaxis of malaria in patients aged 18 years and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 8, 2018 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ArakodaEQ 100MG BASE · tablet;oral | Tafenoquine Succinate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 25, 2022 | Supplement 2Manufacturing | Approved | None posted |
| Aug 8, 2018 | Original applicationNew formulation or manufacturer · 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
