ANDA 211846, held by Sun Pharm. Lenalidomide.
As of Nov 13, 2026, ANDA 211846 (Lenalidomide), held by Sun Pharm, was first approved by FDA on Mar 6, 2023, with 2 approved supplements and 0 published complete response letters.
Lenalidomide capsules are thalidomide analogue indicated for the treatment of adult patients with: Multiple myeloma (MM), in combination with dexamethasone. MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT). Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Previously treated follicular lymphoma (FL), in combination with a rituximab product.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 6, 2023 | Original application | Approved | None posted |
| Feb 8, 2023 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lenalidomide5MG · capsule;oral | Lenalidomide | Rx |
| Lenalidomide10MG · capsule;oral | Lenalidomide | Rx |
| Lenalidomide15MG · capsule;oral | Lenalidomide | Rx |
| Lenalidomide25MG · capsule;oral | Lenalidomide | Rx |
| Lenalidomide2.5MG · capsule;oral | Lenalidomide | Rx |
| Lenalidomide20MG · capsule;oral | Lenalidomide | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 27, 2026 | Supplement 7REMS | Approved | None posted |
| Mar 24, 2023 | Supplement 1REMS | Approved | None posted |
| Mar 6, 2023 | Original application | Approved | None posted |
| Feb 8, 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
