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General MedicationsINTRAVENOUSStandard

PENPULIMAB-KCQX

PENPULIMAB-KCQX

Standard Dose
100MG/10ML(10MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview PENPULIMAB-KCQX is listed in Drugs@FDA under application 761258 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient PENPULIMAB-KCQX Form and strength INJECTABLE;INTRAVENOUS - 100MG/10ML(10MG/ML) Sponsor AKESO BIOPHARMA Submission history Latest submission status date: 2025-04-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview PENPULIMAB-KCQX is listed in Drugs@FDA under application 761258 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient PENPULIMAB-KCQX Form and strength INJECTABLE;INTRAVENOUS - 100MG/10ML(10MG/ML) Sponsor AKESO BIOPHARMA Submission history Latest submission status date: 2025-04-23 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.