ANDA 217113, held by Zydus Lifesciences. Apalutamide.
As of Nov 15, 2026, ANDA 217113 (Apalutamide), held by Zydus Lifesciences, was first approved by FDA on Mar 17, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 17, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Apalutamide60MG ยท tablet;oral | Apalutamide | 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
