NDA 20420, held by Gensia Automedics. Arbutamine Hydrochloride.
As of Nov 14, 2026, NDA 20420 (Genesa), held by Gensia Automedics, was first approved by FDA on Sep 12, 1997, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 12, 1997 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Genesa0.05MG/ML · injectable;injection | Arbutamine Hydrochloride | 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
