Treats onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton…. ANDA 211963, held by Chartwell Rx. Tavaborole.
As of Nov 15, 2026, ANDA 211963 (Tavaborole), held by Chartwell Rx, was first approved by FDA on Feb 3, 2021, with 0 approved supplements and 0 published complete response letters.
Tavaborole topical solution 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 |
|---|---|---|---|
| Feb 3, 2021 | Original application | Approved | None posted |
| 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
