General MedicationsBUCCAL, SUBLINGUALStandard
IGALMI
DEXMEDETOMIDINE HYDROCHLORIDE
Standard Dose
EQ 0.12MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview IGALMI is listed in Drugs@FDA under application 215390 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DEXMEDETOMIDINE HYDROCHLORIDE Form and strength FILM;BUCCAL, SUBLINGUAL - EQ 0.12MG BASE Sponsor BIOXCEL Submission history Latest submission status date: 2025-11-19 00:00:00.
Structured Monograph
Clinical summary
Approval overview IGALMI is listed in Drugs@FDA under application 215390 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DEXMEDETOMIDINE HYDROCHLORIDE Form and strength FILM;BUCCAL, SUBLINGUAL - EQ 0.12MG BASE Sponsor BIOXCEL Submission history Latest submission status date: 2025-11-19 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.