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Last Updated: December 25, 2024

Suppliers and packages for generic ingredient: dexmedetomidine hydrochloride

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dexmedetomidine hydrochloride

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390	NDA	BioXcel Therapeutics, Inc.	81092-1120-1	10 POUCH in 1 CARTON (81092-1120-1) / 1 FILM in 1 POUCH (81092-1120-0)	2022-07-01
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390	NDA	BioXcel Therapeutics, Inc.	81092-1120-3	30 POUCH in 1 CARTON (81092-1120-3) / 1 FILM in 1 POUCH (81092-1120-0)	2022-07-01
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390	NDA	BioXcel Therapeutics, Inc.	81092-1180-1	10 POUCH in 1 CARTON (81092-1180-1) / 1 FILM in 1 POUCH (81092-1180-0)	2022-07-01
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390	NDA	BioXcel Therapeutics, Inc.	81092-1180-3	30 POUCH in 1 CARTON (81092-1180-3) / 1 FILM in 1 POUCH (81092-1180-0)	2022-07-01
Accord Hlthcare	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	204023	ANDA	Accord Healthcare Inc.	16729-239-93	25 VIAL in 1 CARTON (16729-239-93) / 2 mL in 1 VIAL (16729-239-30)	2016-12-21
Accord Hlthcare	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	204023	ANDA	Accord Healthcare Inc.	16729-432-93	25 VIAL in 1 CARTON (16729-432-93) / 2 mL in 1 VIAL (16729-432-30)	2018-08-31
Accord Hlthcare	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	204023	ANDA	Medical Purchasing Solutions, LLC	71872-7030-1	1 VIAL in 1 BAG (71872-7030-1) / 2 mL in 1 VIAL	2016-12-21
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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