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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 209684


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NDA 209684 describes ISOSORBIDE MONONITRATE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Alkermes Gainesville, Aurobindo Pharma, Chartwell Molecular, Dexcel Ltd, Hikma Intl Pharms, Ivax Sub Teva Pharms, Riconpharma Llc, Shandong, Skyepharma Ag, Strides Pharma, Torrent Pharms, Zydus Hlthcare, Zydus Pharms, Ani Pharms, and Hikma Pharms, and is included in twenty NDAs. It is available from twenty-two suppliers. Additional details are available on the ISOSORBIDE MONONITRATE profile page.

The generic ingredient in ISOSORBIDE MONONITRATE is isosorbide mononitrate. There are thirty-seven drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.
Summary for 209684
Tradename:ISOSORBIDE MONONITRATE
Applicant:Accord Hlthcare
Ingredient:isosorbide mononitrate
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Oct 24, 2017TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Oct 24, 2017TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Oct 24, 2017TE:RLD:No

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