ANDA 212215, held by Sun Pharma Canada. Tavaborole.
As of Nov 15, 2026, ANDA 212215 (Tavaborole), held by Sun Pharma Canada, was first approved by FDA on May 7, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 7, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tavaborole5% ยท solution;topical | Tavaborole | Discontinued |
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
