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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Harvard Business School
US Army
AstraZeneca
Federal Trade Commission
Citi
Daiichi Sankyo
Baxter
McKinsey

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086923

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NDA 086923 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-one 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-three suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.
Summary for 086923
Tradename:ISOSORBIDE DINITRATE
Applicant:Par Pharm
Ingredient:isosorbide dinitrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 086923
Ingredient-typeNitrates
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 086923
Suppliers and Packaging for NDA: 086923
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 086923 ANDA Par Pharmaceutical, Inc. 49884-020 N 49884-020-01
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 086923 ANDA Par Pharmaceutical, Inc. 49884-020 N 49884-020-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 12, 1987TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Moodys
Chinese Patent Office
Merck
Harvard Business School
Teva
Fish and Richardson
QuintilesIMS
Healthtrust

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