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approval · primary record

DEXMEDETOMIDINE HYDROCHLORIDE

FDA · NDA · 2025-11-19

AgencyFDA
Submission typeNDA
Action date2025-11-19
BrandIGALMI
SponsorBIOXCEL
RouteBUCCAL, SUBLINGUAL

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-28T02:35:40.903Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: FDA:DEXMEDETOMIDINE HYDROCHLORIDE:2025-11-19

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DEXMEDETOMIDINE HYDROCHLORIDE — approval | AEaH