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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Express Scripts
Argus Health
Healthtrust
QuintilesIMS
Cantor Fitzgerald
AstraZeneca
Deloitte
Citi

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088088

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NDA 088088 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 088088
Tradename:ISOSORBIDE DINITRATE
Applicant:Hikma Intl Pharms
Ingredient:isosorbide dinitrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 088088
Ingredient-typeNitrates
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 088088
Suppliers and Packaging for NDA: 088088
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 088088 ANDA West-Ward Pharmaceuticals Corp 0143-1772 N 0143-1772-01
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 088088 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1575 N 0615-1575-39

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Nov 2, 1987TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Chubb
Deloitte
Mallinckrodt
Fish and Richardson
Harvard Business School
US Army
Johnson and Johnson
McKesson

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