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Last Updated: November 2, 2024

Suppliers and packages for tradename: ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE

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ISOSORBIDE DINITRATE AND HYDRALAZINE 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
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
Riconpharma Llc	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	215586	ANDA	Ingenus Pharmaceuticals, LLC	50742-246-18	180 TABLET in 1 BOTTLE (50742-246-18)	2022-02-12
Riconpharma Llc	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	215586	ANDA	Ingenus Pharmaceuticals, LLC	50742-246-90	90 TABLET in 1 BOTTLE (50742-246-90)	2022-02-12
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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