ANDA 212169, held by Lupin. Efinaconazole.
As of Nov 14, 2026, ANDA 212169 (Efinaconazole), held by Lupin, was first approved by FDA on Mar 2, 2022, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 2, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Efinaconazole10% · solution;topical | Efinaconazole | Discontinued |
| Feb 14, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 2, 2022 | 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
