Treats onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton…. ANDA 212294, held by Zydus Lifesciences. Tavaborole.
As of Nov 15, 2026, ANDA 212294 (Tavaborole), held by Zydus Lifesciences, was first approved by FDA on Apr 10, 2023, 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 |
|---|---|---|---|
| Apr 10, 2023 | 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
