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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 090598


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NDA 090598 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-three 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-five suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.
Summary for 090598
Tradename:ISOSORBIDE MONONITRATE
Applicant:Strides Pharma
Ingredient:isosorbide mononitrate
Patents:0
Pharmacology for NDA: 090598
Physiological EffectVasodilation
Suppliers and Packaging for NDA: 090598
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 090598 ANDA Proficient Rx LP 63187-700 63187-700-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-700-30)
ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 090598 ANDA Proficient Rx LP 63187-700 63187-700-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-700-60)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Aug 11, 2010TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Aug 11, 2010TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Aug 11, 2010TE:RLD:No

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