Treats interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton…. NDA 204286, held by Legacy. Naftifine Hydrochloride.
As of Nov 13, 2026, NDA 204286 (Naftin), held by Legacy, was first approved by FDA on Jun 27, 2013, with 4 approved supplements and 0 published complete response letters.
NAFTIN Gel is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.
| Oct 10, 2014 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jun 27, 2013 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Naftin2% · gel;topical | Naftifine Hydrochloride | RxReference drug |
| Apr 9, 2020 | Supplement 4Labeling · Standard review | Approved | |
| Apr 30, 2018 | Supplement 3Labeling · Standard review | Approved | |
| Oct 10, 2014 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Sep 24, 2014 | Supplement 2Manufacturing · Standard review | Approved | |
| Jun 27, 2013 | Original applicationNew formulation or manufacturer · 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
