Product Details for: Epkinly

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
4MG/0.8ML
Single-Dose Vial
351(a)
Epkinly
Rx
002
Injection
Subcutaneous
48MG/0.8ML
Single-Dose Vial
351(a)
Epkinly
Rx
Proper Name
epcoritamab-bysp
BLA Number
761324
Applicant
Genmab US, Inc.
Original Approval Date
May 19, 2023
Date of First Licensure
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