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Generated: May 30, 2017

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Details for New Drug Application (NDA): 020215

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NDA 020215 describes MONOKET, which is a drug marketed by Kremers Urban Pharms and is included in one NDA. It is available from three 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. Thirty-two suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.

Summary for NDA: 020215

Therapeutic Class:Cardiovascular Agents
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
isosorbide mononitrate
TABLET;ORAL 020215 NDA AUTHORIZED GENERIC Physicians Total Care, Inc. 54868-4478 54868-4478-0 60 TABLET in 1 BOTTLE (54868-4478-0)
isosorbide mononitrate
TABLET;ORAL 020215 NDA AUTHORIZED GENERIC Physicians Total Care, Inc. 54868-4478 54868-4478-1 10 TABLET in 1 BOTTLE (54868-4478-1)

Summary for product number 001

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

Summary for product number 002

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

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