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General MedicationsORALStandard

HYRNUO

SEVABERTINIB

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

Approval overview HYRNUO is listed in Drugs@FDA under application 219972 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient SEVABERTINIB Form and strength TABLET;ORAL - 10MG Sponsor BAYER HEALTHCARE Submission history Latest submission status date: 2025-11-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview HYRNUO is listed in Drugs@FDA under application 219972 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient SEVABERTINIB Form and strength TABLET;ORAL - 10MG Sponsor BAYER HEALTHCARE Submission history Latest submission status date: 2025-11-19 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.