← FDA DRUG APPROVALS

FDA NDA · NDA021983

DUODOTE

atropine and pralidoxime chloride

Sponsor: MMT

APPLICATION
NDA021983
TYPE
NDA
ORIGINAL APPROVAL
2006-09-28
LATEST ACTION
2022-05-17
ROUTE
INTRAMUSCULAR
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

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

Approval history

2022-05-17Labeling · Supplement 38 · standard — Letter ↗AP
2017-10-06Efficacy · Supplement 23 · standard — Label ↗AP
2016-11-03Manufacturing (CMC) · Supplement 22 · standardAP
2016-06-08Manufacturing (CMC) · Supplement 21AP
2016-04-25Manufacturing (CMC) · Supplement 20AP
2016-03-02Manufacturing (CMC) · Supplement 18AP
2015-12-11Manufacturing (CMC) · Supplement 19AP
2015-09-22Manufacturing (CMC) · Supplement 17AP
2014-08-21Manufacturing (CMC) · Supplement 14AP
2013-04-09Manufacturing (CMC) · Supplement 11AP
2006-09-28Type 5 - New Formulation or New Manufacturer · Original · priority — Letter ↗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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