TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

NORPACE

DISOPYRAMIDE PHOSPHATE
Cardiovascular Approved 1977-09-01
3
Indications
--
Phase 3 Trials
1
Priority Reviews
48
Years on Market

Details

Status
Prescription
First Approved
1977-09-01
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Active Ingredient: DISOPYRAMIDE PHOSPHATE

NORPACE Approval History

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What NORPACE Treats

2 indications

NORPACE is approved for 2 conditions since its original approval in 1977. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Ventricular Tachycardia
  • Ventricular Arrhythmias
Source: FDA Label
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Ongoing clinical trials by development phase

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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

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.

NORPACE FDA Label Details

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Indications & Usage

Disopyramide phosphate is indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of disopyramide phosphate, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of disopyramide phosphate treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic d...

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Data Sources

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