ANDA 216921, held by Natco. Idelalisib.
As of Nov 14, 2026, ANDA 216921 (Idelalisib), held by Natco, was first approved by FDA on Feb 17, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 17, 2026 | Original application | Approved |
| Idelalisib100MG · tablet;oral | Idelalisib | Discontinued |
| Idelalisib150MG · tablet;oral | Idelalisib | 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
