Details for New Drug Application (NDA): 210822

NDA 210822 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, Torrent Pharms, Zydus Hlthcare, Zydus Pharms, Ani Pharms, and Hikma Pharms, and is included in twenty NDAs. It is available from twenty-three 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-five suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.

Summary for 210822

Tradename:	ISOSORBIDE MONONITRATE
Applicant:	Dexcel Ltd
Ingredient:	isosorbide mononitrate
Patents:	0

Pharmacology for NDA: 210822

Physiological Effect

Vasodilation

Suppliers and Packaging for NDA: 210822

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	210822	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-628	23155-628-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-628-01)
ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	210822	ANDA	Edenbridge Pharmaceuticals LLC.	42799-960	42799-960-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-960-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	120MG
Approval Date:	Aug 29, 2018	TE:	AB	RLD:	No

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