Treats onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton…. ANDA 212188, held by Alembic. Tavaborole.
As of Nov 15, 2026, ANDA 212188 (Tavaborole), held by Alembic, was first approved by FDA on Oct 21, 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 mentagrophytes. 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 21, 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
