NDA 22055, held by Almirall. Retapamulin.
As of Nov 15, 2026, NDA 22055 (Altabax), held by Almirall, was first approved by FDA on Apr 12, 2007, with 5 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 12, 2007 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Altabax1% · ointment;topical | Retapamulin | DiscontinuedReference drug |
| Sep 10, 2019 | Supplement 7Labeling · Standard review | Approved | |
| Jun 17, 2014 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Aug 1, 2013 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Dec 21, 2012 | Supplement 2Labeling | Approved | |
| Sep 28, 2010 | Supplement 4Labeling · Standard review | Approved | |
| Apr 12, 2007 | 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
