TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

MONOKET

ISOSORBIDE MONONITRATE
Approved 1993-06-30
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
32
Years on Market

Details

Status
Prescription
First Approved
1993-06-30
Routes
ORAL
Dosage Forms
TABLET

Companies

OMNIVIUM PHARMS
Active Ingredient: ISOSORBIDE MONONITRATE

MONOKET Approval History

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What MONOKET Treats

2 indications

MONOKET is approved for 2 conditions since its original approval in 1993. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Angina Pectoris
  • Coronary Artery Disease
Source: FDA Label

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

MONOKET FDA Label Details

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Indications & Usage

FDA Label (PDF)

Isosorbide mononitrate extended-release tablets, USP are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

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Data Sources

FDA Approval: NDA020215 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.