ANDA 79045, held by Fresenius Kabi USA. Bicalutamide.
As of Nov 13, 2026, ANDA 79045 (Bicalutamide), held by Fresenius Kabi USA, was first approved by FDA on May 13, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 13, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bicalutamide50MG ยท tablet;oral | Bicalutamide | 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
