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approval · primary record

DENOSUMAB-ADET

2 approval events · latest 2026-09-29

AgencyFDA
Submission typeBLA
Latest action2026-09-29
Approval events2
BrandPONLIMSI
SponsorTEVA PHARMACEUTICALS, INC.
RouteSUBCUTANEOUS

Approval history

2 actions 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
2026-09-29FDABLAPONLIMSITEVA PHARMACEUTICALS, INC.SUBCUTANEOUS
2026-09-25FDABLADEGEVMATEVA PHARMACEUTICALS, INC.SUBCUTANEOUS

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-30T00:30:27.977Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: approval:denosumab-adet

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Same entity, elsewhere in the suite