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Generated: November 15, 2018

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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-three 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
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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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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