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Abiraterone

Active substance: abiraterone

TABLET, FILM COATED · ABIRATERONE ACETATE 500 mg/1

United StatesActive

Marketing holder: Quallent Pharmaceuticals Health LLC

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 5
  • Abiraterone Accord
    abiraterone acetate
    EMEA/H/C/005408
    Accord Healthcare S.L.U.
  • Abiraterone Krka
    abiraterone acetate
    EMEA/H/C/005649
    Krka, d.d., Novo mesto
  • Abiraterone Mylan
    abiraterone acetate
    EMEA/H/C/005368
    Mylan Pharmaceuticals Limited
  • Akeega
    abiraterone acetate, niraparib (tosilate monohydrate)
    EMEA/H/C/005932
  • Zytiga
    abiraterone acetate
    EMEA/H/C/002321
    Janssen-Cilag International
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-59a4-7772-af69-ceee0232dfe7,01a1208c-83df-7d9d-bf80-d4cfa5708e84,01a1208c-da0d-7232-825f-74703b914aa1,01a1208c-da0e-7c19-b9d5-697b5a74aaea,01a1208c-f279-7c9f-94ed-04becf225d24;count=43 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
82009-140
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 82009-140 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 82009-140 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 82009-140 · Verified 2026-10-09 · open in source