NDA 206545, held by Gilead Sciences Inc. Idelalisib.
As of Nov 14, 2026, NDA 206545 (Zydelig), held by Gilead Sciences Inc, was first approved by FDA on Jul 23, 2014, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 23, 2014 | Original applicationNew indication · Priority review | Approved |
| Zydelig100MG · tablet;oral | Idelalisib | Rx |
| Zydelig150MG · tablet;oral | Idelalisib | 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
