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LAZCLUZE

Active substance: lazertinib

TABLET, FILM COATED · LAZERTINIB 80 mg/1

United StatesActive

Marketing holder: Janssen Biotech, Inc.

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
EU 1
  • Lazcluze
    lazertinib mesilate monohydrate
    EMEA/H/C/006074
    Janssen Cilag International NV
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208e-833e-779a-8644-70013ce088ea,01a1208f-f659-771f-b076-05f5c602ee3c;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
57894-080
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 57894-080 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 57894-080 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 57894-080 · Verified 2026-10-09 · open in source