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Isosorbide mononitrate - Generic Drug Details

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Isosorbide mononitrate is the generic ingredient in four branded drugs marketed by Actavis Elizabeth, Hikma Pharms, Kremers Urban Pharms, Dexcel Ltd, Schering Plough, Alkermes Gainesville, Ani Pharms Inc, Ivax Sub Teva Pharms, Hikma Pharms Llc, Skyepharma Ag, Torrent Pharms, Promius Pharma, Nesher Pharms, and Vintage Pharms, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-seven drug master file entries for isosorbide mononitrate. Twenty-eight suppliers are listed for this compound.

Summary for Generic Name: isosorbide mononitrate

Drug Master File Entries: see list37
Suppliers / Packaging: see list28
Therapeutic Class:Cardiovascular Agents
Drug Prices:see low prices

Pharmacology for Ingredient: isosorbide mononitrate

Drug ClassNitrate Vasodilator
Physiological EffectVasodilation

Clinical Trials for: isosorbide mononitrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma Pharms Llc
isosorbide mononitrate
TABLET;ORAL075361-001Oct 5, 2000RXNo
Promius Pharma
isosorbide mononitrate
TABLET;ORAL019091-001Dec 30, 1991DISCNNo
Dexcel Ltd
isosorbide mononitrate
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