NDA 21430, held by Celgene. Thalidomide.
As of Nov 15, 2026, NDA 21430 (Thalomid), held by Celgene, was first approved by FDA on May 25, 2006, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 25, 2006 | Original applicationTYPE 6 · Standard review | Approved |
| Thalomid50MG · capsule; oral | Thalidomide | Rx |
| Thalomid100MG · capsule; oral | Thalidomide | Rx |
| Thalomid200MG · capsule; oral | Thalidomide | Rx |
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