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Last Updated: November 21, 2024

Suppliers and packages for generic ingredient: HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

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HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

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
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727	NDA	Azurity	24338-010-09	90 TABLET, FILM COATED in 1 BOTTLE (24338-010-09)	2012-12-05
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727	NDA AUTHORIZED GENERIC	Wilshire Pharmaceuticals	52536-006-09	90 TABLET, FILM COATED in 1 BOTTLE (52536-006-09)	2022-04-15
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727	NDA AUTHORIZED GENERIC	Bryant Ranch Prepack	72162-2343-9	90 TABLET, FILM COATED in 1 BOTTLE (72162-2343-9)	2022-04-15
I3 Pharms	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	215988	ANDA	i3 Pharmaceuticals, LLC	72319-012-03	90 TABLET, FILM COATED in 1 BOTTLE (72319-012-03)	2024-02-07
I3 Pharms	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	215988	ANDA	i3 Pharmaceuticals, LLC	72319-012-18	180 TABLET, FILM COATED in 1 BOTTLE (72319-012-18)	2024-02-07
I3 Pharms	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	215988	ANDA	A2A Integrated Pharmaceuticals	73141-012-03	90 TABLET, FILM COATED in 1 BOTTLE (73141-012-03)	2024-04-22
I3 Pharms	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	215988	ANDA	A2A Integrated Pharmaceuticals	73141-012-18	180 TABLET, FILM COATED in 1 BOTTLE (73141-012-18)	2024-04-22
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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