NDA 211739, held by Cristal Asu LLC. Oxygen.
As of Nov 14, 2026, NDA 211739 (Oxygen, Usp), held by Cristal Asu LLC, was first approved by FDA on Sep 10, 2018, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 10, 2018 | Original applicationMEDGAS | 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
