Enzalutamide
ANDA 217322, held by Zydus Pharms USA Inc. Enzalutamide.
- First approved: Not approved
- Supplements approved: 0
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 30, 2024 | Original application | Tentative approval | None posted |
Products
2 strengths and forms| Product | Active ingredient | Marketing |
|---|---|---|
| Enzalutamide40MG · tablet;oral | Enzalutamide | None (tentative approval) |
| Enzalutamide80MG · tablet;oral | Enzalutamide | None (tentative approval) |
Identifiers
- Application
- ANDA 217322
- Drugs@FDA
- Overview at FDA
- Company
- Zydus Pharmaceuticals (USA)
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