ANDA 213405, held by Torrent. Lenalidomide.
As of Nov 13, 2026, ANDA 213405 (Lenalidomide), held by Torrent, was first approved by FDA on Aug 3, 2023, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 3, 2023 | Original application | Approved | None posted |
| Feb 17, 2023 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lenalidomide10MG · capsule;oral | Lenalidomide | Discontinued |
| Lenalidomide25MG · capsule;oral | Lenalidomide | Discontinued |
| Lenalidomide20MG · capsule;oral | Lenalidomide | Discontinued |
| Lenalidomide15MG · capsule;oral | Lenalidomide | Discontinued |
| Lenalidomide2.5MG · capsule;oral | Lenalidomide | Discontinued |
| Lenalidomide5MG · capsule;oral | Lenalidomide | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 27, 2026 | Supplement 5REMS | Approved | None posted |
| Aug 3, 2023 | Original application | Approved | None posted |
| Mar 24, 2023 | Supplement 1REMS | Approved | None posted |
| Feb 17, 2023 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
