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General MedicationsSUBCUTANEOUSStandard

EPKINLY

EPCORITAMAB-BYSP

Standard Dose
48MG/0.8ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview EPKINLY is listed in Drugs@FDA under application 761324 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient EPCORITAMAB-BYSP Form and strength INJECTABLE;SUBCUTANEOUS - 48MG/0.8ML Sponsor GENMAB US, INC.

Structured Monograph

Clinical summary

Approval overview EPKINLY is listed in Drugs@FDA under application 761324 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient EPCORITAMAB-BYSP Form and strength INJECTABLE;SUBCUTANEOUS - 48MG/0.8ML Sponsor GENMAB US, INC. Submission history Latest submission status date: 2026-03-27 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.