ANDA 210275, held by Mylan. Pomalidomide.
As of Nov 13, 2026, ANDA 210275 (Pomalidomide), held by Mylan, was first approved by FDA on Jan 26, 2022, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 26, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pomalidomide1MG · capsule;oral | Pomalidomide | Discontinued |
| Pomalidomide2MG · capsule;oral | Pomalidomide | Discontinued |
| Pomalidomide3MG · capsule;oral | Pomalidomide | Discontinued |
| Pomalidomide4MG · capsule;oral | Pomalidomide | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 27, 2026 | Supplement 5REMS | Approved | None posted |
| Oct 17, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 5, 2025 | Supplement 2REMS | Approved | None posted |
| Jan 26, 2022 | Original application | Approved |
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
