ANDA 212066, held by Aurobindo Pharma Ltd. Efinaconazole.
As of Nov 14, 2026, ANDA 212066 (Efinaconazole), held by Aurobindo Pharma Ltd, was first approved by FDA on Mar 29, 2021, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Efinaconazole10% · solution;topical | Efinaconazole | Discontinued |
| Jun 14, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 14, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 29, 2021 | Original application | Approved | None posted |
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
