Xenon Xe 133

NDA 18327, held by Curium. Xenon Xe-133.

As of Nov 13, 2026, NDA 18327 (Xenon Xe 133), held by Curium, was first approved by FDA on Mar 9, 1982, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 9, 1982
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Mar 9, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Xenon Xe 13310mCi/VIAL · gas;inhalation	Xenon Xe-133	Rx
Xenon Xe 13320mCi/VIAL · gas;inhalation	Xenon Xe-133	Rx

All 4 submissions, including labeling and manufacturing supplements


Mar 9, 2016	Supplement 5Manufacturing · Standard review	Approved	Label
Sep 19, 1997	Supplement 3Manufacturing · Standard review	Approved	None posted
May 26, 1988	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 9, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18327
Drugs@FDA: Overview at FDA
Company: Curium

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