Application Information

This drug has been submitted to the FDA under the reference 040009/001.

Names and composition

"ISOSORBIDE DINITRATE" is the commercial name of a drug composed of ISOSORBIDE DINITRATE.
It belongs to the class Nitrates and is used in MI, LVD (Cardiovascular System)

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
040009/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE/ORAL 40MG
040591/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 30MG
040723/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE/ORAL 40MG
084204/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 2.5MG
086031/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
086032/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 10MG
086033/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
086034/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 5MG
086054/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 2.5MG
086055/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 5MG
086066/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 10MG
086067/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 5MG
086166/002 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 5MG
086167/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 20MG
086168/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 5MG
086169/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 10MG
086221/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 5MG
086222/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 5MG
086223/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 10MG
086225/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 2.5MG
086923/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 5MG
086925/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 10MG
087537/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 20MG
087545/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 10MG
087564/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 30MG
087946/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 30MG
088088/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 20MG
089190/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 5MG
089191/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 10MG
089192/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 20MG
089367/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 20MG

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
012093/001 ISORDIL ISOSORBIDE DINITRATE TABLET/ORAL 40MG
012093/002 ISORDIL ISOSORBIDE DINITRATE TABLET/ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
012093/005 ISORDIL ISOSORBIDE DINITRATE TABLET/ORAL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
012093/006 ISORDIL ISOSORBIDE DINITRATE TABLET/ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
012093/007 ISORDIL ISOSORBIDE DINITRATE TABLET/ORAL 5MG
012882/001 ISORDIL ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE/ORAL 40MG
012882/002 ISORDIL ISOSORBIDE DINITRATE CAPSULE, EXTENDED RELEASE/ORAL 40MG
012940/003 ISORDIL ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
012940/004 ISORDIL ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
012940/005 ISORDIL ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
016191/001 SORBITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 5MG
016191/002 SORBITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 2.5MG
016192/001 SORBITRATE ISOSORBIDE DINITRATE TABLET/ORAL 5MG
016192/002 SORBITRATE ISOSORBIDE DINITRATE TABLET/ORAL 10MG
016776/002 SORBITRATE ISOSORBIDE DINITRATE TABLET, CHEWABLE/ORAL 5MG
016776/003 SORBITRATE ISOSORBIDE DINITRATE TABLET, CHEWABLE/ORAL 10MG
019790/001 DILATRATE-SR ISOSORBIDE DINITRATE CAPSULE, EXTENDED RELEASE/ORAL 40MG
040009/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE/ORAL 40MG
040591/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 30MG
040723/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE/ORAL 40MG
084204/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 2.5MG
086031/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
086032/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 10MG
086033/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
086034/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 5MG
086054/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 2.5MG
086055/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 5MG
086066/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 10MG
086067/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 5MG
086166/002 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 5MG
086167/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 20MG
086168/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 5MG
086169/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 10MG
086221/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 5MG
086222/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 5MG
086223/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 10MG
086225/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 2.5MG
086405/002 SORBITRATE ISOSORBIDE DINITRATE TABLET/ORAL 20MG
086923/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 5MG
086925/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 10MG
087537/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 20MG
087545/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/SUBLINGUAL 10MG
087564/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 30MG
087946/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 30MG
088088/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 20MG
088124/001 SORBITRATE ISOSORBIDE DINITRATE TABLET/ORAL 30MG
088125/001 SORBITRATE ISOSORBIDE DINITRATE TABLET/ORAL 40MG
089190/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 5MG
089191/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 10MG
089192/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 20MG
089367/001 ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET/ORAL 20MG

Manufacturers

Manufacturer name
Merus Labs Luxco S.a.R.L.

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