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ERLEADA

Active substance: apalutamide

TABLET, FILM COATED · APALUTAMIDE 240 mg/1

United StatesActive

Marketing holder: Janssen Products, LP

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
  • Erleada
    apalutamide
    EMEA/H/C/004452
    Janssen-Cilag International NV
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12096-702c-7b04-8b4a-349c94f18317,01a12098-e07c-76fb-9774-5fa4eb9747b3;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
59676-604
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 59676-604 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 59676-604 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 59676-604 · Verified 2026-10-09 · open in source