← FDA DRUG APPROVALS

FDA NDA · NDA219008

LAZCLUZE

lazertinib

Sponsor: JANSSEN BIOTECH

APPLICATION
NDA219008
TYPE
NDA
ORIGINAL APPROVAL
2024-08-19
LATEST ACTION
2026-04-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LAZCLUZE · ReferencePrescription
LAZERTINIB MESYLATE EQ 80MG BASE · TABLET · ORAL
LAZCLUZE · ReferencePrescription
LAZERTINIB MESYLATE EQ 240MG BASE · TABLET · ORAL

Approval history

2026-04-30Labeling · Supplement 4 · standard — Letter ↗AP
2025-11-07Labeling · Supplement 3 · standard — Letter ↗AP
2025-08-14Efficacy · Supplement 2 · standard — Letter ↗AP
2024-08-19Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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