Active Ingredient: DEXMEDETOMIDINE HYDROCHLORIDE
Proprietary Name: IGALMI
Dosage Form; Route of Administration: FILM; BUCCAL, SUBLINGUAL
Strength: EQ 0.12MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N215390
Product Number: 001
Approval Date: Apr 5, 2022
Applicant Holder Full Name: BIOXCEL THERAPEUTICS INC
Marketing Status:
Prescription
Patent and Exclusivity Information