NDA 217500, held by Absolute Air, LLC. Oxygen.
As of Nov 13, 2026, NDA 217500 (Oxygen, Usp), held by Absolute Air, LLC, was first approved by FDA on Jun 10, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 10, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxygen, UspN/A ยท gas;inhalation | Oxygen | Rx |
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