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approval · primary record

TRASTUZUMAB-DTTB

FDA · BLA · 2026-04-15

AgencyFDA
Submission typeBLA
Action date2026-04-15
BrandONTRUZANT
SponsorSAMSUNG BIOEPIS CO LTD
RouteIV (INFUSION)

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-28T02:35:13.346Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: FDA:TRASTUZUMAB-DTTB:2026-04-15

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TRASTUZUMAB-DTTB — approval | AEaH