Last Updated: November 8, 2026

Details for New Drug Application (NDA): 012093

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NDA 012093 describes ISORDIL, which is a drug marketed by Wyeth Ayerst, Bausch, 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 is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.
Summary for 012093
Tradename:ISORDIL
Applicant:Bausch
Ingredient:isosorbide dinitrate
Patents:0
Pharmacology for NDA: 012093
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 012093
Nitric Oxide Donors
Vasodilator Agents
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 Oceanside Pharmaceuticals 68682-192 68682-192-01 100 TABLET in 1 BOTTLE (68682-192-01)
ISORDIL isosorbide dinitrate TABLET;ORAL 012093 NDA Oceanside Pharmaceuticals 68682-193 68682-193-01 100 TABLET in 1 BOTTLE (68682-193-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jul 29, 1988TE:ABRLD: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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jul 29, 1988TE:RLD:Yes

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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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