← FDA Drug Approvals (Drugs@FDA)
ANDEMBRY
BLA · Biologics License Application · Sponsor: CSL BEHRING LLC · Approved 2025-06-16
Drug application
- FDA Application #
BLA761367- Application type
- Biologics License Application
- Brand name
- ANDEMBRY
- Generic name
- GARADACIMAB
- Active ingredients
- GARADACIMAB-GXII
- Dosage form
- INJECTABLE
- Route
- SUBCUTANEOUS
- Marketing status
- Prescription
- Sponsor
- CSL BEHRING LLC
- Manufacturer
- CSL
- First approval
- 2025-06-16
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown