# NUBEQA
> **NDA212099** · New Drug Application · Sponsor: BAYER HEALTHCARE · Approved 2019-07-30
## Drug
- **FDA Application Number:** NDA212099
- **Application type:** New Drug Application
- **Brand name:** NUBEQA
- **Generic name:** DAROLUTAMIDE
- **Active ingredients:** DAROLUTAMIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** BAYER HEALTHCARE
- **Manufacturer:** Bayer HealthCare Pharmaceuticals Inc.
- **First approval:** 2019-07-30
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212099)
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