NDA 213990, held by ILMO Products Company. Helium.
As of Nov 14, 2026, NDA 213990 (Helium, Usp), held by ILMO Products Company, was first approved by FDA on Oct 27, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 27, 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
