NDA 213609, held by Roberts Oxygen Co Inc. Helium.
As of Nov 13, 2026, NDA 213609 (Helium, Usp), held by Roberts Oxygen Co Inc, was first approved by FDA on Jul 14, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 14, 2019 | 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
