NDA 205767, held by Linde North America Inc. Oxygen.
As of Nov 13, 2026, NDA 205767 (Oxygen, Usp), held by Linde North America Inc, was first approved by FDA on Jul 5, 2013, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 5, 2013 | Original applicationMEDGAS · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxygen, UspN/A · 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
