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IGALMI

NDA · New Drug Application · Sponsor: BIOXCEL · Approved 2022-04-05

Drug application

FDA Application #

NDA215390

Application type

New Drug Application

Brand name

IGALMI

Generic name

Dexmedetomidine Hydrochloride

Active ingredients

DEXMEDETOMIDINE HYDROCHLORIDE

Dosage form

FILM

Route

BUCCAL, SUBLINGUAL

Marketing status

Prescription

Sponsor

BIOXCEL

First approval

2022-04-05

Source

Authoritative

Drugs@FDA application overview

Machine

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