Treats onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton…. ANDA 211297, held by Encube. Tavaborole.
As of Nov 15, 2026, ANDA 211297 (Tavaborole), held by Encube, was first approved by FDA on Oct 13, 2020, with 0 approved supplements and 0 published complete response letters.
Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophyte. Tavaborole topical solution is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 13, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tavaborole5% · solution;topical | Tavaborole | Rx |
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
