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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215390

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IGALMI (DEXMEDETOMIDINE HYDROCHLORIDE)
EQ 0.12MG BASE
Marketing Status: Prescription
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
IGALMI (DEXMEDETOMIDINE HYDROCHLORIDE)
EQ 0.18MG BASE
Marketing Status: Prescription
Active Ingredient: DEXMEDETOMIDINE HYDROCHLORIDE
Proprietary Name: IGALMI
Dosage Form; Route of Administration: FILM; BUCCAL, SUBLINGUAL
Strength: EQ 0.18MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215390
Product Number: 002
Approval Date: Apr 5, 2022
Applicant Holder Full Name: BIOXCEL THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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