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approval · primary record

DENOSUMAB-DSSB

FDA · BLA · 2025-10-29

AgencyFDA
Submission typeBLA
Action date2025-10-29
BrandDENOSUMAB-DSSB
SponsorSAMSUNG BIOEPIS CO LTD
RouteSUBCUTANEOUS

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-28T02:34:42.028Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: FDA:DENOSUMAB-DSSB:2025-10-29

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DENOSUMAB-DSSB — approval | AEaH