NDA 22244, held by Eisai Inc. Fospropofol Disodium.
As of Nov 14, 2026, NDA 22244 (Lusedra), held by Eisai Inc, was first approved by FDA on Dec 8, 2008, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 8, 2008 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lusedra1050MG/30ML (35MG/ML) · solution;intravenous | Fospropofol Disodium | 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
