🇺🇸 ABP 501 in United States

FDA authorised ABP 501 on 23 September 2016

Marketing authorisation

FDA — authorised 23 September 2016

  • Application: BLA761024
  • Marketing authorisation holder: AMGEN INC
  • Local brand name: AMJEVITA
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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Other Immunology / Rheumatology approved in United States

Frequently asked questions

Is ABP 501 approved in United States?

Yes. FDA authorised it on 23 September 2016.

Who is the marketing authorisation holder for ABP 501 in United States?

AMGEN INC holds the US marketing authorisation.