NDA 22310, held by Astrazeneca. Bicalutamide.
As of Nov 13, 2026, NDA 22310 (Casodex), held by Astrazeneca, was first approved by FDA on Dec 19, 2008, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 2008 | Original applicationTYPE 6 · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Casodex50MG · tablet; oral | Bicalutamide | 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
