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approval · primary record

DENOSUMAB-NXXP

FDA · BLA · 2025-10-29

AgencyFDA
Submission typeBLA
Latest action2025-10-29
Approval events1
BrandBILPREVDA
SponsorSHANGHAI HENLIUS BIOTECH
RouteINJECTION

Approval history

1 action on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.

DateAgencyTypeBrandSponsorRoute
2025-10-29FDABLABILPREVDASHANGHAI HENLIUS BIOTECHINJECTION

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-30T00:31:09.508Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: approval:denosumab-nxxp

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Same entity, elsewhere in the suite