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approval · primary record

DARATUMUMAB

FDA · BLA · 2026-05-28

AgencyFDA
Submission typeBLA
Action date2026-05-28
BrandDARZALEX
SponsorJANSSEN BIOTECH
RouteINJECTION

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-28T02:34:58.678Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: FDA:DARATUMUMAB:2026-05-28

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DARATUMUMAB — approval | AEaH