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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 086033

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NDA 086033 describes ISOSORBIDE DINITRATE, which is a drug marketed by Impax Labs Inc, Sun Pharm Inds Inc, Ani Pharms, Endo Operations, Hikma Intl Pharms, Rubicon, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus Lifesciences, Watson Labs Teva, I3 Pharms, and Riconpharma Llc, and is included in thirty-six NDAs. It is available from twenty 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 086033

Tradename:	ISOSORBIDE DINITRATE
Applicant:	Watson Labs
Ingredient:	isosorbide dinitrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 086033

Nitric Oxide Donors
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;SUBLINGUAL			Strength	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 26, 1988	TE:		RLD:	No

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