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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 075166

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NDA 075166 describes ISOSORBIDE MONONITRATE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Alkermes Gainesville, Aurobindo Pharma, Chartwell Molecular, Dexcel Ltd, Hikma Intl Pharms, Ivax Sub Teva Pharms, Riconpharma Llc, Shandong, Skyepharma Ag, Strides Pharma Intl, Torrent Pharms, Zydus Hlthcare, Zydus Pharms, Ani Pharms, Genus, and Hikma Pharms, and is included in twenty NDAs. It is available from twenty-one suppliers. Additional details are available on the ISOSORBIDE MONONITRATE profile page.

The generic ingredient in ISOSORBIDE MONONITRATE is isosorbide mononitrate. There are thirty-seven drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.

Summary for 075166

Tradename:	ISOSORBIDE MONONITRATE
Applicant:	Skyepharma Ag
Ingredient:	isosorbide mononitrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	60MG
Approval Date:	Oct 7, 1999	TE:		RLD:	No

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