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FDA NDA · NDA021175

ATNAA ATROPINE AND PRALIDOXIME CHLORIDE AUTO-INJECTOR

atropine and pralidoxime chloride

Sponsor: US ARMY

APPLICATION
NDA021175
TYPE
NDA
ORIGINAL APPROVAL
2002-01-17
LATEST ACTION
2022-05-26
ROUTE
INTRAMUSCULAR
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ATNAADiscontinued
ATROPINE 2.1MG/0.7ML, PRALIDOXIME CHLORIDE 600MG/2ML · INJECTABLE · INTRAMUSCULAR

Approval history

2022-05-26Labeling · Supplement 47 · standard — Letter ↗AP
2020-05-22Labeling · Supplement 41 · standard — Label ↗AP
2016-11-03Manufacturing (CMC) · Supplement 32 · standardAP
2016-05-27Manufacturing (CMC) · Supplement 31 · priorityAP
2016-04-25Manufacturing (CMC) · Supplement 30 · priorityAP
2016-03-02Manufacturing (CMC) · Supplement 27 · priorityAP
2015-12-11Manufacturing (CMC) · Supplement 29 · priorityAP
2015-09-22Manufacturing (CMC) · Supplement 28 · priorityAP
2015-02-03Manufacturing (CMC) · Supplement 26 · priorityAP
2015-01-20Manufacturing (CMC) · Supplement 25 · priorityAP
2014-05-15Manufacturing (CMC) · Supplement 24 · priorityAP
2002-09-10Manufacturing (CMC) · Supplement 1 · priorityAP
2002-01-17Type 3 - New Dosage Form · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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