NDA 21191, held by Vesselon Spv LLC. Dimyristoyl Lecithin; Perflexane.
As of Nov 13, 2026, NDA 21191 (Imagent), held by Vesselon Spv LLC, was first approved by FDA on May 31, 2002, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 31, 2002 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Imagent0.92MG/VIAL;0.092MG/VIAL · injectable;intravenous | Dimyristoyl Lecithin; Perflexane | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 21, 2004 | Supplement 1Manufacturing · Standard review | Approved | |
| May 31, 2002 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
