NDA 205843, held by Airgas USA LLC. Helium.
As of Nov 14, 2026, NDA 205843 (Helium, Usp), held by Airgas USA LLC, was first approved by FDA on Jul 20, 2013, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 20, 2013 | Original applicationMEDGAS · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Helium, UspN/A · 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
