NDA 17283, held by Lantheus Medcl. Xenon Xe-133.
As of Nov 13, 2026, NDA 17283 (Xenon Xe 133), held by Lantheus Medcl, was first approved by FDA on Oct 11, 1974, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 11, 1974 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xenon Xe 1336.3mCi/ML · injectable;injection | Xenon Xe-133 | Discontinued |
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
