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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 215586


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NDA 215586 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 215586
Tradename:ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
Applicant:Novast Labs
Ingredient:hydralazine hydrochloride; isosorbide dinitrate
Patents:0
Pharmacology for NDA: 215586
Physiological EffectArteriolar 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:RXDosage:TABLET;ORALStrength37.5MG;20MG
Approval Date:Apr 6, 2022TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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