ANDA 212027, held by Alembic. Efinaconazole.
As of Nov 14, 2026, ANDA 212027 (Efinaconazole), held by Alembic, was first approved by FDA on Feb 23, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 23, 2026 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Efinaconazole10% ยท solution;topical | Efinaconazole | 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
