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General MedicationsORALStandard

HERNEXEOS

ZONGERTINIB

Standard Dose
60MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview HERNEXEOS is listed in Drugs@FDA under application 219042 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient ZONGERTINIB Form and strength TABLET;ORAL - 60MG Sponsor BOEHRINGER INGELHEIM Submission history Latest submission status date: 2026-02-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview HERNEXEOS is listed in Drugs@FDA under application 219042 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient ZONGERTINIB Form and strength TABLET;ORAL - 60MG Sponsor BOEHRINGER INGELHEIM Submission history Latest submission status date: 2026-02-26 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Prescription
  • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.
HERNEXEOS (ZONGERTINIB) | Drug Monograph | MedicHelpline