MedPath
FDA Approval

EPKINLY

May 24, 2023

HUMAN PRESCRIPTION DRUG LABEL

Epcoritamab(48 mg in 0.8 mL)

Products (2)

EPKINLY

82705-010

BLA761324

BLA (C73585)

SUBCUTANEOUS

May 16, 2023

Code: D6OMY2L0WAClass: ACTIBQuantity: 48 mg in 0.8 mL
sodium acetateInactive
Code: 4550K0SC9BClass: IACT
SorbitolInactive
Code: 506T60A25RClass: IACT
acetic acidInactive
Code: Q40Q9N063PClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT

EPKINLY

82705-002

BLA761324

BLA (C73585)

SUBCUTANEOUS

May 16, 2023

Code: D6OMY2L0WAClass: ACTIBQuantity: 4 mg in 0.8 mL
acetic acidInactive
Code: Q40Q9N063PClass: IACT
sodium acetateInactive
Code: 4550K0SC9BClass: IACT
SorbitolInactive
Code: 506T60A25RClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
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