ANDA 211827, held by Teva Pharms USA. Efinaconazole.
As of Nov 14, 2026, ANDA 211827 (Efinaconazole), held by Teva Pharms USA, was first approved by FDA on Dec 16, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 16, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Efinaconazole10% ยท solution;topical | Efinaconazole | 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
