Protopam Chloride

NDA 14122, held by Wyeth Ayerst. Pralidoxime Chloride.

As of Nov 13, 2026, NDA 14122 (Protopam Chloride), held by Wyeth Ayerst, was first approved by FDA on Mar 12, 1964, with 10 approved supplements and 0 published complete response letters.

First approved: Mar 12, 1964
Review: Priority
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Mar 12, 1964	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Protopam Chloride500MG · tablet;oral	Pralidoxime Chloride	Discontinued

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 24, 1987	Supplement 16Manufacturing · Priority review	Approved	None posted
Aug 21, 1985	Supplement 15Manufacturing · Priority review	Approved	None posted
Jul 3, 1985	Supplement 14Labeling · Priority review	Approved	None posted
May 20, 1985	Supplement 13Manufacturing · Priority review	Approved	None posted
Jun 16, 1981	Supplement 12Manufacturing · Priority review	Approved	None posted
Oct 1, 1979	Supplement 11Manufacturing · Priority review	Approved	None posted
Oct 1, 1979	Supplement 10Manufacturing · Priority review	Approved	None posted
Nov 11, 1974	Supplement 9	Approved	None posted
Nov 8, 1974	Supplement 5Manufacturing · Priority review	Approved	None posted
Jun 27, 1974	Supplement 8	Approved	None posted
Mar 12, 1964	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 14122
Drugs@FDA: Overview at FDA
Company: Wyeth-Ayerst

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