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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087946

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NDA 087946 describes ISOSORBIDE DINITRATE, which is a drug marketed by Impax Labs Inc, Sun Pharm Inds Inc, Hikma Intl Pharms, Par Pharm, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, and Watson Labs Teva, and is included in thirty-one NDAs. It is available from twenty-three suppliers. Additional details are available on the ISOSORBIDE DINITRATE profile page.

The generic ingredient in ISOSORBIDE DINITRATE is isosorbide dinitrate. 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 dinitrate profile page.

Summary for 087946

Tradename:	ISOSORBIDE DINITRATE
Applicant:	Par Pharm
Ingredient:	isosorbide dinitrate
Patents:	0
Therapeutic Class:	Cardiovascular Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 087946

Ingredient-type	Nitrates
Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for 087946

Nitric Oxide Donors
Vasodilator Agents

Suppliers and Packaging for NDA: 087946

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	087946	ANDA	NCS HealthCare of KY, Inc dba Vangard Labs	0615-7584	N	0615-7584-39
ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	087946	ANDA	NCS HealthCare of KY, Inc dba Vangard Labs	0615-8193	N	0615-8193-39

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Jan 12, 1988	TE:	AB	RLD:	No

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