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General MedicationsORALStandard

LAZCLUZE

LAZERTINIB MESYLATE

Standard Dose
EQ 240MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview LAZCLUZE is listed in Drugs@FDA under application 219008 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient LAZERTINIB MESYLATE Form and strength TABLET;ORAL - EQ 240MG BASE Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2025-11-07 00:00:00.

Structured Monograph

Clinical summary

Approval overview LAZCLUZE is listed in Drugs@FDA under application 219008 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LAZERTINIB MESYLATE Form and strength TABLET;ORAL - EQ 240MG BASE Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2025-11-07 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.