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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 019790

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NDA 019790 describes DILATRATE-SR, which is a drug marketed by Endo Operations and is included in one NDA. Additional details are available on the DILATRATE-SR profile page.

The generic ingredient in DILATRATE-SR is isosorbide dinitrate. There are thirty-seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.

Summary for 019790

Tradename:	DILATRATE-SR
Applicant:	Endo Operations
Ingredient:	isosorbide dinitrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 019790

Nitric Oxide Donors
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	40MG
Approval Date:	Sep 2, 1988	TE:		RLD:	Yes

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