ANDA 211716, held by Aurobindo Pharma Ltd. Apremilast.
As of Nov 13, 2026, ANDA 211716 (Apremilast), held by Aurobindo Pharma Ltd, was first approved by FDA on Jul 19, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 19, 2023 | Original application | Approved | None posted |
| 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
