ANDA 77995, held by Kudco Ireland. Bicalutamide.
As of Nov 13, 2026, ANDA 77995 (Bicalutamide), held by Kudco Ireland, was first approved by FDA on Jul 6, 2009, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 6, 2009 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bicalutamide50MG ยท tablet;oral | Bicalutamide | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 30, 2010 | Supplement 1Labeling | Approved | None posted |
| Jul 6, 2009 | Original application | Approved |
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
