Xenon Xe 133-V.S.S., Xenon Xe 133

NDA 17687, held by Ge Healthcare. Xenon Xe-133.

As of Nov 15, 2026, NDA 17687 (Xenon Xe 133-V.S.S., Xenon Xe 133), held by Ge Healthcare, was first approved by FDA on Nov 16, 1976, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 16, 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
Nov 16, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms


Xenon Xe 133-V.S.S.10mCi/VIAL · gas;inhalation	Xenon Xe-133	Discontinued
Xenon Xe 13310mCi/VIAL · gas;inhalation	Xenon Xe-133	Discontinued
Xenon Xe 13320mCi/VIAL · gas;inhalation	Xenon Xe-133	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Nov 7, 1986	Supplement 4Labeling · Standard review	Approved	None posted
May 22, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 27, 1981	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 16, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17687
Drugs@FDA: Overview at FDA
Company: GE 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