Xenon Xe 127

NDA 18536, held by Mallinckrodt. Xenon Xe-127.

As of Nov 13, 2026, NDA 18536 (Xenon Xe 127), held by Mallinckrodt, was first approved by FDA on Oct 1, 1982, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 1, 1982
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 1, 1982	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Xenon Xe 1275mCi/VIAL · gas;inhalation	Xenon Xe-127	Discontinued
Xenon Xe 12710mCi/VIAL · gas;inhalation	Xenon Xe-127	Discontinued

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 18, 1983	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 21, 1983	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 1, 1982	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 18536
Drugs@FDA: Overview at FDA
Company: Mallinckrodt

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