Xenon Xe 133

NDA 17550, held by Gen Electric. Xenon Xe-133.

As of Nov 13, 2026, NDA 17550 (Xenon Xe 133), held by Gen Electric, was first approved by FDA on Mar 24, 1976, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 24, 1976
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Mar 24, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Xenon Xe 1335-100 CI/CYLINDER · gas;inhalation	Xenon Xe-133	Discontinued
Xenon Xe 1330.25-5 CI/AMP · gas;inhalation	Xenon Xe-133	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jul 31, 1986	Supplement 6Labeling	Approved	None posted
May 30, 1986	Supplement 5Labeling	Approved	None posted
Dec 12, 1979	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 24, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17550
Drugs@FDA: Overview at FDA
Company: Gen Electric

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