Details for New Drug Application (NDA): 215586

NDA 215586 describes ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE, which is a drug marketed by I3 Pharms and Riconpharma Llc and is included in two NDAs. It is available from three suppliers. Additional details are available on the ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE profile page.

The generic ingredient in ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE is hydralazine hydrochloride; isosorbide dinitrate. There are twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydralazine hydrochloride; isosorbide dinitrate profile page.

Summary for 215586

Tradename:	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
Applicant:	Riconpharma Llc
Ingredient:	hydralazine hydrochloride; isosorbide dinitrate
Patents:	0

Pharmacology for NDA: 215586

Physiological Effect

Arteriolar Vasodilation Vasodilation

Suppliers and Packaging for NDA: 215586

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	215586	ANDA	Ingenus Pharmaceuticals, LLC	50742-246	50742-246-18	180 TABLET in 1 BOTTLE (50742-246-18)
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	215586	ANDA	Ingenus Pharmaceuticals, LLC	50742-246	50742-246-90	90 TABLET in 1 BOTTLE (50742-246-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	37.5MG;20MG
Approval Date:	Apr 6, 2022	TE:	AB	RLD:	No

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