ANDA 90924, held by Mylan Institutional. Ibutilide Fumarate.
As of Nov 15, 2026, ANDA 90924 (Ibutilide Fumarate), held by Mylan Institutional, was first approved by FDA on Jan 11, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 11, 2010 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ibutilide Fumarate0.1MG/ML ยท injectable;injection | Ibutilide Fumarate | 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
