NDA 17284, held by Shine. Xenon Xe-133.
As of Nov 14, 2026, NDA 17284 (Xenon Xe 133), held by Shine, was first approved by FDA on Oct 10, 1974, with 11 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: Inhalation of Xenon Xe 133 Gas has proved valuable for the evaluation of pulmonary function and for imaging the lungs. It may also be applied to assessment of cerebral flow.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 10, 1974 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Xenon Xe 13310mCi/VIAL · gas;inhalation | Xenon Xe-133 | Rx |
| Xenon Xe 13320mCi/VIAL · gas;inhalation | Xenon Xe-133 | Rx |
| Jun 10, 2016 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Sep 14, 2011 | Supplement 12Labeling | Approved | |
| Oct 27, 2003 | Supplement 9Labeling · Standard review | Approved | |
| Mar 27, 1998 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1991 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Feb 24, 1989 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| May 4, 1987 | Supplement 5Labeling | Approved | None posted |
| May 21, 1982 | Supplement 4Labeling | Approved | None posted |
| Jul 20, 1981 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Sep 29, 1978 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Apr 7, 1978 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1974 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
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
