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General MedicationsINJECTIONStandard

JEMPERLI

DOSTARLIMAB-GXLY

Standard Dose
500MG/10ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview JEMPERLI is listed in Drugs@FDA under application 761223 (BLA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient DOSTARLIMAB-GXLY Form and strength INJECTABLE;INJECTION - 500MG/10ML Sponsor GLAXOSMITHKLINE LLC Submission history Latest submission status date: 2021-08-17 00:00:00.

Structured Monograph

Clinical summary

Approval overview JEMPERLI is listed in Drugs@FDA under application 761223 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient DOSTARLIMAB-GXLY Form and strength INJECTABLE;INJECTION - 500MG/10ML Sponsor GLAXOSMITHKLINE LLC Submission history Latest submission status date: 2021-08-17 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.