ANDA 211674, held by Glenmark Pharms Ltd. Apremilast.
As of Nov 13, 2026, ANDA 211674 (Apremilast), held by Glenmark Pharms Ltd, was first approved by FDA on Oct 16, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 16, 2023 | 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
