NDA 205851, held by Praxair Inc. Helium.
As of Nov 14, 2026, NDA 205851 (Helium, Usp), held by Praxair Inc, was first approved by FDA on Jul 21, 2013, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 21, 2013 | Original applicationMEDGAS · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Helium, UspN/A · gas;inhalation | Helium | Discontinued |
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
