Artesunate

As of Nov 14, 2026, NDA 213036 (Artesunate), held by Amivas, was first approved by FDA on May 26, 2020, with 5 approved supplements and 0 published complete response letters.

First approved: May 26, 2020
Review: Priority
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
May 26, 2020	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Artesunate110MG/VIAL · powder;intravenous	Artesunate	RxReference drug

All 6 submissions, including labeling and manufacturing supplements


Apr 13, 2026	Supplement 13Labeling · Standard review	Approved	Letter
Jan 16, 2025	Supplement 8Labeling · Standard review	Approved	Label Letter
Jul 31, 2023	Supplement 4Labeling · Standard review	Approved	Label Letter
Mar 3, 2023	Supplement 3Labeling · Standard review	Approved	Letter Label
Feb 4, 2022	Supplement 1Labeling · Standard review	Approved	Letter Label
May 26, 2020	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 213036
Drugs@FDA: Overview at FDA
Company: AMIVAS

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