Details for New Drug Application (NDA): 075037

NDA 075037 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 075037

Tradename:	ISOSORBIDE MONONITRATE
Applicant:	Genus
Ingredient:	isosorbide mononitrate
Patents:	0

Pharmacology for NDA: 075037

Physiological Effect

Vasodilation

Suppliers and Packaging for NDA: 075037

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET;ORAL	075037	ANDA	Actavis Pharma, Inc.	0228-2620	0228-2620-11	100 TABLET in 1 BOTTLE (0228-2620-11)
ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET;ORAL	075037	ANDA	Actavis Pharma, Inc.	0228-2631	0228-2631-11	100 TABLET in 1 BOTTLE (0228-2631-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Oct 30, 1998	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Oct 30, 1998	TE:	AB	RLD:	No

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