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General MedicationsINTRAVENOUSStandard

DANYELZA

NAXITAMAB-GQGK

Standard Dose
40MG/10ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview DANYELZA is listed in Drugs@FDA under application 761171 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient NAXITAMAB-GQGK Form and strength SOLUTION;INTRAVENOUS - 40MG/10ML Sponsor Y-MABS THERAPEUTICS INC Submission history Latest submission status date: 2025-08-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview DANYELZA is listed in Drugs@FDA under application 761171 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient NAXITAMAB-GQGK Form and strength SOLUTION;INTRAVENOUS - 40MG/10ML Sponsor Y-MABS THERAPEUTICS INC Submission history Latest submission status date: 2025-08-27 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.