← FDA Drug Approvals (Drugs@FDA)
EPKINLY
BLA · Biologics License Application · Sponsor: GENMAB US, INC. · Approved 2023-05-19
Drug application
- FDA Application #
BLA761324
- Application type
- Biologics License Application
- Brand name
- EPKINLY
- Generic name
- EPCORITAMAB-BYSP
- Active ingredients
- EPCORITAMAB-BYSP
- Dosage form
- INJECTABLE
- Route
- SUBCUTANEOUS
- Marketing status
- Prescription
- Sponsor
- GENMAB US, INC.
- Manufacturer
- Genmab US, Inc.
- First approval
- 2023-05-19
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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