Treats interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms…. NDA 204153, held by Bausch. Luliconazole.
As of Nov 13, 2026, NDA 204153 (Luzu), held by Bausch, was first approved by FDA on Nov 14, 2013, with 4 approved supplements and 0 published complete response letters.
Luliconazole Cream, 1% is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum.
| Feb 20, 2018 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Feb 20, 2018 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Nov 14, 2013 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Luzu1% · cream;topical | Luliconazole | RxReference drug |
| Feb 20, 2018 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Feb 20, 2018 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Feb 8, 2017 | Supplement 2Labeling · Standard review | Approved | |
| Jun 7, 2016 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Nov 14, 2013 | 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
