ANDA 209645, held by Apotex. Enzalutamide.
As of Nov 13, 2026, ANDA 209645 (Enzalutamide), held by Apotex, was first approved by FDA on Apr 22, 2022, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 22, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Enzalutamide40MG · capsule;oral | Enzalutamide | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 19, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 22, 2022 | Original application | Approved | None posted |
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
