NDA 208069, held by Strata Medical Innovations. Nitrous Oxide.
As of Nov 13, 2026, NDA 208069 (Nitrous Oxide, Usp), held by Strata Medical Innovations, was first approved by FDA on Nov 25, 2014, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 25, 2014 | Original applicationMEDGAS | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nitrous Oxide, UspN/A ยท gas;inhalation | Nitrous Oxide | 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