# ENZALUTAMIDE
> **ANDA218731** · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA PHARMACEUTICALS USA INC · Approved 2026-02-02
## Drug
- **FDA Application Number:** ANDA218731
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** ENZALUTAMIDE
- **Generic name:** Enzalutamide
- **Active ingredients:** ENZALUTAMIDE
- **Dosage form:** TABLET
- **Route:** —
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** HIKMA PHARMACEUTICALS USA INC
- **First approval:** 2026-02-02
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218731)
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