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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Julphar
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Deloitte
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Covington

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 012940

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NDA 012940 describes ISORDIL, which is a drug marketed by Wyeth Ayerst, Valeant Pharms North, and Biovail, and is included in three NDAs. It is available from one supplier. Additional details are available on the ISORDIL profile page.

The generic ingredient in ISORDIL 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 012940
Tradename:ISORDIL
Applicant:Biovail
Ingredient:isosorbide dinitrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 012940

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jul 29, 1988TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrength2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jul 29, 1988TE:RLD:Yes

Profile for product number 005

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jul 29, 1988TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Argus Health
UBS
Johnson and Johnson
Deloitte
Daiichi Sankyo
Express Scripts
US Department of Justice
Dow

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