← FDA Drug Approvals (Drugs@FDA)
BRUKINSA
NDA · New Drug Application · Sponsor: BEONE MEDICINES USA · Approved 2025-06-10
Drug application
- FDA Application #
NDA218785- Application type
- New Drug Application
- Brand name
- BRUKINSA
- Generic name
- ZANUBRUTINIB
- Active ingredients
- ZANUBRUTINIB
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- BEONE MEDICINES USA
- Manufacturer
- BeOne Medicines USA, Inc.
- First approval
- 2025-06-10
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown