NDA 206826, held by Linde Gas North America LLC. Helium.
As of Nov 14, 2026, NDA 206826 (Helium, Usp), held by Linde Gas North America LLC, was first approved by FDA on Mar 4, 2014, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 4, 2014 | Original applicationMEDGAS | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Helium, UspN/A ยท gas;inhalation | Helium | 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
