Protopam Chloride

NDA 18799, held by Baxter Hlthcare Corp. Pralidoxime Chloride.

As of Nov 13, 2026, NDA 18799 (Protopam Chloride), held by Baxter Hlthcare Corp, was first approved by FDA on Dec 13, 1982, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 13, 1982
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 13, 1982	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Protopam Chloride300MG/ML · injectable;injection	Pralidoxime Chloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 8, 1983	Supplement 1Labeling	Approved	None posted
Dec 13, 1982	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18799
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