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Boehringer Ingelheim

Last Updated: February 26, 2024

Details for New Drug Application (NDA): 020215

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NDA 020215 describes MONOKET, which is a drug marketed by Genus Lifesciences and is included in one NDA. It is available from two suppliers. Additional details are available on the MONOKET profile page.

The generic ingredient in MONOKET is isosorbide mononitrate. There are thirty-seven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.
Summary for 020215
Applicant:Genus Lifesciences
Ingredient:isosorbide mononitrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 020215
Physiological EffectVasodilation
Suppliers and Packaging for NDA: 020215
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONOKET isosorbide mononitrate TABLET;ORAL 020215 NDA AUTHORIZED GENERIC Lannett Company, Inc. 62175-106 62175-106-01 100 TABLET in 1 BOTTLE (62175-106-01)
MONOKET isosorbide mononitrate TABLET;ORAL 020215 NDA AUTHORIZED GENERIC Lannett Company, Inc. 62175-107 62175-107-01 100 TABLET in 1 BOTTLE (62175-107-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jun 30, 1993TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 30, 1993TE:ABRLD:Yes

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