ANDA 211897, held by Teva Pharms USA Inc. Apremilast.
As of Nov 13, 2026, ANDA 211897 (Apremilast), held by Teva Pharms USA Inc, was first approved by FDA on Aug 18, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 18, 2022 | 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
