← FDA Drug Approvals (Drugs@FDA)
DARZALEX
BLA · Biologics License Application · Sponsor: JANSSEN BIOTECH · Approved 2015-11-16
Drug application
- FDA Application #
BLA761036- Application type
- Biologics License Application
- Brand name
- DARZALEX
- Generic name
- DARATUMUMAB
- Active ingredients
- DARATUMUMAB
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Sponsor
- JANSSEN BIOTECH
- Manufacturer
- Janssen Biotech, Inc.
- First approval
- 2015-11-16
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown