← FDA Drug Approvals (Drugs@FDA)
NUBEQA
NDA · New Drug Application · Sponsor: BAYER HEALTHCARE · Approved 2019-07-30
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown