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approval · primary record

DENOSUMAB-MOBZ

FDA · BLA · 2025-12-19

AgencyFDA
Submission typeBLA
Latest action2025-12-19
Approval events1
BrandBONCRESA
SponsorAMNEAL PHARMS LLC
RouteSUBCUTANEOUS

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
2025-12-19FDABLABONCRESAAMNEAL PHARMS LLCSUBCUTANEOUS

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-30T00:30:00.625Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: approval:denosumab-mobz

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Same entity, elsewhere in the suite