ANDA 90643, held by Pharmobedient. Ibutilide Fumarate.
As of Nov 15, 2026, ANDA 90643 (Ibutilide Fumarate), held by Pharmobedient, 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
