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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 086221

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NDA 086221 describes ISOSORBIDE DINITRATE, which is a drug marketed by Impax Labs Inc, Sun Pharm Inds Inc, Ani Pharms, Hikma Intl Pharms, Ph Health, Rubicon, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus Lifesciences, Watson Labs Teva, MLV, and Novast Labs, and is included in thirty-three NDAs. It is available from nineteen suppliers. Additional details are available on the ISOSORBIDE DINITRATE profile page.

The generic ingredient in ISOSORBIDE DINITRATE 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 086221

Tradename:	ISOSORBIDE DINITRATE
Applicant:	Sandoz
Ingredient:	isosorbide dinitrate
Patents:	0

Pharmacology for NDA: 086221

Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for 086221

Nitric Oxide Donors
Vasodilator Agents

Suppliers and Packaging for NDA: 086221

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	086221	ANDA	Sandoz Inc.	0781-1635	0781-1635-01	100 TABLET in 1 BOTTLE (0781-1635-01)
ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	086221	ANDA	Sandoz Inc.	0781-1635	0781-1635-10	1000 TABLET in 1 BOTTLE (0781-1635-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jan 7, 1988	TE:	AB	RLD:	No

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