Pralidoxime Chloride (Autoinjector)

NDA 18986, held by Meridian Medcl Techn. Pralidoxime Chloride.

As of Nov 13, 2026, NDA 18986 (Pralidoxime Chloride (Autoinjector)), held by Meridian Medcl Techn, was first approved by FDA on Apr 26, 1983, with 24 approved supplements and 0 published complete response letters.

First approved: Apr 26, 1983
Review: Standard
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Apr 26, 1983	Original applicationNew formulation or manufacturer · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pralidoxime Chloride (Autoinjector)600MG/2ML (300MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;intramuscular	Pralidoxime Chloride	DiscontinuedReference drug

All 25 submissions, including labeling and manufacturing supplements


Jan 5, 2015	Supplement 45Manufacturing · Standard review	Approved	None posted
Aug 21, 2014	Supplement 44Manufacturing · Standard review	Approved	None posted
Dec 31, 2013	Supplement 43Manufacturing · Standard review	Approved	None posted
Oct 24, 2002	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 28, 2002	Supplement 21Manufacturing · Standard review	Approved	None posted
Mar 1, 2002	Supplement 20Manufacturing · Standard review	Approved	None posted
Feb 25, 2002	Supplement 19Manufacturing · Standard review	Approved	None posted
Feb 15, 2002	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 28, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
Jan 23, 2001	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 2, 2000	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 27, 2000	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 10, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 28, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 8, 1998	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 21, 1998	Supplement 10Labeling · Standard review	Approved	None posted
Mar 6, 1997	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 23, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 18, 1991	Supplement 7Labeling	Approved	None posted
Jul 31, 1986	Supplement 5Labeling	Approved	None posted
Mar 21, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 26, 1986	Supplement 2Labeling	Approved	None posted
May 14, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 6, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 26, 1983	Original applicationNew formulation or manufacturer · Standard review	Approved	Review

Identifiers

Application: NDA 18986
Drugs@FDA: Overview at FDA
Company: Meridian Medcl Techn

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