ANDA 211761, held by Alkem Labs Ltd. Apremilast.
As of Nov 13, 2026, ANDA 211761 (Apremilast), held by Alkem Labs Ltd, was first approved by FDA on Sep 21, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 21, 2021 | Original application | Approved |
| Apremilast10MG · tablet;oral | Apremilast | Rx |
| Apremilast20MG · tablet;oral | Apremilast | Rx |
| Apremilast30MG · tablet;oral | Apremilast | 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
