NDA 21946, held by Ina Pharms. Ketoconazole.
As of Nov 14, 2026, NDA 21946 (Xolegel), held by Ina Pharms, was first approved by FDA on Jul 28, 2006, with 6 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 28, 2006 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xolegel2% · gel;topical | Ketoconazole | DiscontinuedReference drug |
| Dec 26, 2019 | Supplement 7Labeling · Standard review | Approved | |
| Feb 27, 2013 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| May 10, 2012 | Supplement 5Labeling | Approved | |
| Dec 6, 2010 | Supplement 4Labeling | Approved | |
| Dec 30, 2009 | Supplement 3Labeling · Standard review | Approved | |
| Dec 19, 2008 | Supplement 2Manufacturing | Approved | |
| Jul 28, 2006 | Original applicationNew dosage form · 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
