Application Information

This drug has been submitted to the FDA under the reference 075037/001.

Names and composition

"ISOSORBIDE MONONITRATE" is the commercial name of a drug composed of ISOSORBIDE MONONITRATE.
It belongs to the class Nitrates and is used in Heart failure (Cardiovascular System)

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
075037/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET/ORAL 20MG
075037/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET/ORAL 10MG
075041/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
075147/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET/ORAL 20MG
075155/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
075155/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 30MG
075155/003 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 120MG
075166/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
075306/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 30MG
075306/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
075361/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET/ORAL 20MG
075395/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 30MG
075395/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
075395/003 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 120MG
075448/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
075448/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 30MG
075448/003 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 120MG
075522/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
075522/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 30MG
076813/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
076813/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 30MG
090598/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 30MG
090598/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
090598/003 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 120MG
200270/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 30MG
200495/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
200495/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 120MG

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
019091/001 ISMO ISOSORBIDE MONONITRATE TABLET/ORAL 20MG
020215/001 MONOKET ISOSORBIDE MONONITRATE TABLET/ORAL 20MG
020215/002 MONOKET ISOSORBIDE MONONITRATE TABLET/ORAL 10MG
020225/001 IMDUR ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020225/002 IMDUR ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020225/003 IMDUR ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
075037/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET/ORAL 20MG
075037/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET/ORAL 10MG
075041/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
075147/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET/ORAL 20MG
075155/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
075155/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 30MG
075155/003 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 120MG
075166/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
075306/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 30MG
075306/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
075361/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET/ORAL 20MG
075395/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 30MG
075395/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
075395/003 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 120MG
075448/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
075448/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 30MG
075448/003 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 120MG
075522/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
075522/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 30MG
076813/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
076813/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 30MG
090598/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 30MG
090598/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
090598/003 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 120MG
200270/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 30MG
200495/001 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 60MG
200495/002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE/ORAL 120MG

Manufacturers

Manufacturer name
Concordia International
Ranbaxy (UK) Ltd
Merus Labs Luxco S.a.R.L.
AstraZeneca UK Ltd
Sinclair Is Pharma
Intrapharm Laboratories Ltd
Galen Ltd
Kyowa Kirin International
Chiesi Ltd
Teva UK Ltd
Actavis UK Ltd
Genus Pharmaceuticals

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