BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Baxter
Julphar
Daiichi Sankyo
US Department of Justice
QuintilesIMS
Moodys
Queensland Health
Citi
Healthtrust
Cantor Fitzgerald

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 012093

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NDA 012093 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-six suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.
Summary for 012093
Tradename:ISORDIL
Applicant:Valeant Pharms North
Ingredient:isosorbide dinitrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 012093
Ingredient-typeNitrates
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 012093
Suppliers and Packaging for NDA: 012093
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISORDIL isosorbide dinitrate TABLET;ORAL 012093 NDA Valeant Pharmaceuticals North America LLC 0187-0152 0187-0152-01 100 TABLET in 1 BOTTLE (0187-0152-01)
ISORDIL isosorbide dinitrate TABLET;ORAL 012093 NDA Valeant Pharmaceuticals North America LLC 0187-0192 0187-0192-01 100 TABLET in 1 BOTTLE (0187-0192-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jul 29, 1988TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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;ORALStrength30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 leading biopharmaceutical companies globally:

Accenture
Teva
Boehringer Ingelheim
Cipla
Baxter
QuintilesIMS
Cantor Fitzgerald
Merck
Covington

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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