NDA 22129, held by Shionogi. Benzyl Alcohol.
As of Nov 13, 2026, NDA 22129 (Ulesfia), held by Shionogi, was first approved by FDA on Apr 9, 2009, with 5 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 9, 2009 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ulesfia5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · lotion;topical | Benzyl Alcohol | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 26, 2020 | Supplement 8Labeling · Standard review | Approved | |
| Mar 24, 2016 | Supplement 6Manufacturing | Approved | None posted |
| Jul 12, 2012 | Supplement 5Labeling | Approved | |
| Jun 22, 2010 | Supplement 2Labeling | Approved | |
| Feb 3, 2010 | Supplement 1Manufacturing | Approved | None posted |
| Apr 9, 2009 | Original applicationNew molecular entity · Standard review | Approved |
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
