Treats poisoning. NDA 21983, held by Mmt. Atropine; Pralidoxime Chloride.
As of Nov 14, 2026, NDA 21983 (Duodote), held by Mmt, was first approved by FDA on Sep 28, 2006, with 10 approved supplements and 0 published complete response letters.
DuoDote is indicated for the treatment of poisoning by organophosphorus nerve agents as well as organophosphorus insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds).
| Oct 6, 2017 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | |
| Sep 28, 2006 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Duodote2.1MG/0.7ML;600MG/2ML · injectable;intramuscular | Atropine; Pralidoxime Chloride | RxReference drug |
| May 17, 2022 | Supplement 38Labeling · Standard review | Approved | |
| Oct 6, 2017 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | |
| Nov 3, 2016 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jun 8, 2016 | Supplement 21Manufacturing | Approved | None posted |
| Apr 25, 2016 | Supplement 20Manufacturing | Approved | None posted |
| Mar 2, 2016 | Supplement 18Manufacturing | Approved | None posted |
| Dec 11, 2015 | Supplement 19Manufacturing | Approved | None posted |
| Sep 22, 2015 | Supplement 17Manufacturing | Approved | None posted |
| Aug 21, 2014 | Supplement 14Manufacturing | Approved | None posted |
| Apr 9, 2013 | Supplement 11Manufacturing | Approved | None posted |
| Sep 28, 2006 | 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
