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approval · primary record

ENASIDENIB MESYLATE

FDA · NDA · 2025-01-16

AgencyFDA
Submission typeNDA
Latest action2025-01-16
Approval events1
BrandIDHIFA
SponsorBRISTOL MYERS SQUIBB
RouteORAL

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
2025-01-16FDANDAIDHIFABRISTOL MYERS SQUIBBORAL

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-30T00:31:19.052Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: approval:enasidenib-mesylate

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Same entity, elsewhere in the suite