Details for New Drug Application (NDA): 200495

NDA 200495 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-two 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 200495

Tradename:	ISOSORBIDE MONONITRATE
Applicant:	Torrent Pharms
Ingredient:	isosorbide mononitrate
Patents:	0

Pharmacology for NDA: 200495

Physiological Effect

Vasodilation

Suppliers and Packaging for NDA: 200495

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	200495	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7768	0615-7768-05	15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7768-05)
ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	200495	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7768	0615-7768-39	30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7768-39)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	60MG
Approval Date:	Jun 3, 2011	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	120MG
Approval Date:	Jun 3, 2011	TE:	AB	RLD:	No

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