Details for New Drug Application (NDA): 215988

NDA 215988 describes ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE, which is a drug marketed by MLV and Novast Labs 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 215988

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

Pharmacology for NDA: 215988

Physiological Effect

Arteriolar Vasodilation Vasodilation

Suppliers and Packaging for NDA: 215988

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	215988	ANDA	i3 Pharmaceuticals, LLC	72319-012	72319-012-03	90 TABLET, FILM COATED in 1 BOTTLE (72319-012-03)
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	215988	ANDA	i3 Pharmaceuticals, LLC	72319-012	72319-012-18	180 TABLET, FILM COATED in 1 BOTTLE (72319-012-18)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	37.5MG;20MG
Approval Date:	Jan 17, 2024	TE:	AB	RLD:	No

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