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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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