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FDA NDA · NDA215390

IGALMI

Sponsor: BIOXCEL

APPLICATION
NDA215390
TYPE
NDA
ORIGINAL APPROVAL
2022-04-05
LATEST ACTION
2025-11-19
ROUTE
BUCCAL, SUBLINGUAL
DOSAGE FORM
FILM
MARKETING STATUS
Prescription

Products

IGALMI · ReferencePrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 0.18MG BASE · FILM · BUCCAL, SUBLINGUAL
IGALMI · ReferencePrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 0.12MG BASE · FILM · BUCCAL, SUBLINGUAL

Approval history

2025-11-19Efficacy · Supplement 2 · standard — Label ↗AP
2022-10-24Labeling · Supplement 1 · standard — Letter ↗AP
2022-04-05Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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