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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 Biovail, Wyeth Ayerst, and Valeant Pharms North, 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-eight suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.

Summary for NDA: 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

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)

Summary for product number 001

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

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No


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