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Last Updated: December 22, 2024

Suppliers and packages for tradename: 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
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
Amneal	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	216604	ANDA	Amneal Pharmaceuticals LLC	70121-1711-2	15 POUCH in 1 CARTON (70121-1711-2) / 1 BAG in 1 POUCH / 50 mL in 1 BAG	2023-05-19
Amneal	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	216604	ANDA	Amneal Pharmaceuticals LLC	70121-1711-9	24 POUCH in 1 CARTON (70121-1711-9) / 1 BAG in 1 POUCH / 50 mL in 1 BAG	2023-05-19
Amneal	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	216604	ANDA	Amneal Pharmaceuticals LLC	70121-1712-2	10 POUCH in 1 CARTON (70121-1712-2) / 1 BAG in 1 POUCH / 100 mL in 1 BAG	2023-05-19
Amneal	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	216604	ANDA	Amneal Pharmaceuticals LLC	70121-1712-3	12 POUCH in 1 CARTON (70121-1712-3) / 1 BAG in 1 POUCH / 100 mL in 1 BAG	2023-05-19
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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