Enzalutamide
Sold as Xtandi. Every FDA application for this active ingredient: 2 branded and 7 generic.
- First approved: Aug 31, 2012
- Applications: 9
- New uses approved: 13
- Complete response letters: 0
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Aug 31, 2012 | XtandiNDA 203415 · New molecular entity | Astellas | 20 | Marketed |
| Aug 4, 2020 | XtandiNDA 213674 · New dosage form | Astellas | 8 | Marketed |
| May 14, 2021 | EnzalutamideANDA 209614 | Actavis Labs Fl Inc | 0 | Discontinued |
| Apr 22, 2022 | EnzalutamideANDA 209645 | Apotex | 1 | Discontinued |
| Sep 26, 2024 | EnzalutamideANDA 209667 | Zydus Pharms | 0 | Discontinued |
| Apr 20, 2026 | EnzalutamideANDA 216068 | Sandoz | 0 | Marketed |
| — | EnzalutamideANDA 217322 | Zydus Pharms USA Inc | 0 | Discontinued |
| — | EnzalutamideANDA 218731 | Hikma Pharmaceuticals USA Inc | 0 | Discontinued |
| — | EnzalutamideANDA 219675 | Haimen Pharma Inc | 0 | Discontinued |
SandozApplications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Drugs@FDA