ANDA 209614, held by Actavis Labs Fl Inc. Enzalutamide.
As of Nov 13, 2026, ANDA 209614 (Enzalutamide), held by Actavis Labs Fl Inc, was first approved by FDA on May 14, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 14, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Enzalutamide40MG ยท capsule;oral | Enzalutamide | Discontinued |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
