ANDA 211819, held by Unichem. Apremilast.
As of Nov 13, 2026, ANDA 211819 (Apremilast), held by Unichem, was first approved by FDA on Feb 17, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 17, 2021 | Original application | Approved |
| Apremilast10MG · tablet;oral | Apremilast | Discontinued |
| Apremilast20MG · tablet;oral | Apremilast | Discontinued |
| Apremilast30MG · tablet;oral | Apremilast | 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
