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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Fuji
Queensland Health
Chubb
McKinsey
Cerilliant
Mallinckrodt
Farmers Insurance
Novartis
Moodys

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086067

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NDA 086067 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-four 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-six suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.
Summary for 086067
Tradename:ISOSORBIDE DINITRATE
Applicant:Hikma Intl Pharms
Ingredient:isosorbide dinitrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 086067
Ingredient-typeNitrates
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 086067
Suppliers and Packaging for NDA: 086067
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 086067 ANDA West-Ward Pharmaceuticals Corp 0143-1769 N 0143-1769-01
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 086067 ANDA Hikma Pharmaceutical 59115-143 N 59115-143-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 29, 1987TE:ABRLD:No

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Cantor Fitzgerald
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