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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Argus Health
UBS
QuintilesIMS
Cantor Fitzgerald
Citi
Colorcon
Deloitte
Baxter

Generated: January 23, 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-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 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 49884-020-01 100 TABLET in 1 BOTTLE (49884-020-01)
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 086923 ANDA Par Pharmaceutical Inc. 49884-020 49884-020-10 1000 TABLET in 1 BOTTLE (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 leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
Baxter
Fish and Richardson
Citi
Chubb
Johnson and Johnson
Cipla
AstraZeneca

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