Treats edema associated with congestive heart failure, hepatic … the nephrotic syndrome. NDA 219500, held by Corstasis Therap. Bumetanide.
As of Nov 15, 2026, NDA 219500 (Enbumyst), held by Corstasis Therap, was first approved by FDA on Sep 12, 2025, with 0 approved supplements and 0 published complete response letters.
ENBUMYST is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 12, 2025 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Enbumyst0.5MG/SPRAY · spray;nasal | Bumetanide | RxReference drug |
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
