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ACTIVE SUBSTANCE / INN

DEXMEDETOMIDINE HYDROCHLORIDE

Brand name(s): PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE, IGALMI
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
ANDA203773
ANDA208129
ACTIVE SUBSTANCE
Dexmedetomidine Hydrochloride
REGULATORS
FDA
SPONSORS / MAH
AM REGENT, HOSPIRA, BIOXCEL
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DEXMEDETOMIDINE HYDROCHLORIDEANDA202585RISINGPrescription
PRECEDEXNDA021038HOSPIRAPrescription
DEXMEDETOMIDINE HYDROCHLORIDEANDA203773AM REGENTDiscontinued
IGALMINDA215390BIOXCELPrescription
DEXMEDETOMIDINE HYDROCHLORIDEANDA208129FRESENIUS KABI USANone (Tentative Approval)

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