Protopam Chloride

Treats poisoning due to those pesticides and chemicals. NDA 14134, held by Baxter Hlthcare Corp. Pralidoxime Chloride.

As of Nov 13, 2026, NDA 14134 (Protopam Chloride), held by Baxter Hlthcare Corp, was first approved by FDA on Mar 11, 1964, with 23 approved supplements and 0 published complete response letters.

First approved: Mar 11, 1964
Review: Priority
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE PROTOPAM Chloride is indicated as an antidote: in the treatment of poisoning due to those pesticides and chemicals (e.g., nerve agents) of the organophosphate class which have anticholinesterase activity and in the control of overdosage by anticholinesterase drugs used in the treatment of myasthenia gravis. The principal indications for the use of PROTOPAM Chloride are muscle weakness and respiratory depression. In severe poisoning, respiratory depression may be due to muscle weakness.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Mar 11, 1964	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Protopam Chloride1GM/VIAL · injectable;injection	Pralidoxime Chloride	RxReference drug

All 24 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 15, 2014	Supplement 35Manufacturing · Priority review	Approved	None posted
May 3, 2013	Supplement 34Manufacturing · Priority review	Approved	None posted
Nov 30, 2012	Supplement 32Manufacturing · Priority review	Approved	None posted
Sep 8, 2010	Supplement 22Labeling · Standard review	Approved	Letter Label
Dec 4, 2002	Supplement 25Manufacturing · Priority review	Approved	None posted
Sep 27, 2002	Supplement 24Labeling · Standard review	Approved	Letter Label
May 6, 2002	Supplement 23Manufacturing · Priority review	Approved	None posted
Dec 11, 1995	Supplement 21Labeling · Standard review	Approved	None posted
Apr 26, 1993	Supplement 19Manufacturing · Priority review	Approved	None posted
Apr 28, 1992	Supplement 20Manufacturing · Priority review	Approved	None posted
Apr 28, 1992	Supplement 17Manufacturing · Priority review	Approved	None posted
Jul 15, 1991	Supplement 18Manufacturing · Priority review	Approved	None posted
May 21, 1986	Supplement 16Manufacturing · Priority review	Approved	None posted
Aug 23, 1985	Supplement 15Manufacturing · Priority review	Approved	None posted
Aug 21, 1985	Supplement 14Manufacturing · Priority review	Approved	None posted
Jul 2, 1985	Supplement 13Labeling	Approved	None posted
May 20, 1985	Supplement 12Manufacturing · Priority review	Approved	None posted
Jun 17, 1981	Supplement 10Manufacturing · Priority review	Approved	None posted
Feb 13, 1981	Supplement 9Manufacturing · Priority review	Approved	None posted
Sep 11, 1980	Supplement 8Manufacturing · Priority review	Approved	None posted
Apr 15, 1980	Supplement 7Manufacturing · Priority review	Approved	None posted
Mar 28, 1978	Supplement 6Manufacturing · Priority review	Approved	None posted
Nov 11, 1974	Supplement 5Manufacturing · Priority review	Approved	None posted
Mar 11, 1964	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 14134
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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