Treats onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton…. NDA 203567, held by Bausch. Efinaconazole.
As of Nov 13, 2026, NDA 203567 (Jublia), held by Bausch, was first approved by FDA on Jun 6, 2014, with 7 approved supplements and 0 published complete response letters.
JUBLIA (efinaconazole) topical solution, 10% is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
| Apr 26, 2020 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Jun 6, 2014 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Jublia10% · solution;topical | Efinaconazole | RxReference drug |
| Mar 31, 2022 | Supplement 10Labeling · Standard review | Approved | |
| Apr 26, 2020 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Sep 22, 2016 | Supplement 6Labeling · Standard review | Approved | |
| Apr 1, 2016 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Nov 5, 2015 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Aug 26, 2015 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Feb 27, 2015 | Supplement 2Labeling · Standard review | Approved | |
| Jun 6, 2014 | 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
