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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 012940


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NDA 012940 describes ISORDIL, which is a drug marketed by Wyeth Ayerst, Bausch, and Biovail, and is included in three NDAs. It is available from two suppliers. 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-two 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
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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jul 29, 1988TE:RLD:Yes

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