ANDA 216242, held by Macleods Pharms. Crisaborole.
As of Nov 14, 2026, ANDA 216242 (Crisaborole), held by Macleods Pharms, was first approved by FDA on Sep 24, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 24, 2026 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Crisaborole2% ยท ointment;topical | Crisaborole | 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
