Atnaa

Treats poisoning. NDA 21175, held by US Army. Atropine; Pralidoxime Chloride.

As of Nov 14, 2026, NDA 21175 (Atnaa), held by US Army, was first approved by FDA on Jan 17, 2002, with 13 approved supplements and 0 published complete response letters.

First approved: Jan 17, 2002
Review: Priority
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ATNAA is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Jan 17, 2002	Original applicationNew dosage form · Priority review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Atnaa2.1MG/0.7ML;600MG/2ML · injectable;intramuscular	Atropine; Pralidoxime Chloride	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Oct 10, 2026	Supplement 56Labeling · Standard review	Approved	None posted
May 26, 2022	Supplement 47Labeling · Standard review	Approved	Label Letter
May 22, 2020	Supplement 41Labeling · Standard review	Approved	Letter Label
Nov 3, 2016	Supplement 32Manufacturing · Standard review	Approved	None posted
May 27, 2016	Supplement 31Manufacturing · Priority review	Approved	None posted
Apr 25, 2016	Supplement 30Manufacturing · Priority review	Approved	None posted
Mar 2, 2016	Supplement 27Manufacturing · Priority review	Approved	None posted
Dec 11, 2015	Supplement 29Manufacturing · Priority review	Approved	None posted
Sep 22, 2015	Supplement 28Manufacturing · Priority review	Approved	None posted
Feb 3, 2015	Supplement 26Manufacturing · Priority review	Approved	None posted
Jan 20, 2015	Supplement 25Manufacturing · Priority review	Approved	None posted
May 15, 2014	Supplement 24Manufacturing · Priority review	Approved	None posted
Sep 10, 2002	Supplement 1Manufacturing · Priority review	Approved	None posted
Jan 17, 2002	Original applicationNew dosage form · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 21175
Drugs@FDA: Overview at FDA
Company: US Army

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