TheraRadar
Data updated: May 26, 2026

NORPACE (disopyramide phosphate)

Cardiovascular Approved 1977-09-01

NORPACE is indicated for the treatment of Ventricular Tachycardia; Ventricular Arrhythmias.

Source: FDA Label • Pfizer
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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Original
New Indication
New Form
Label Update
96 FDA actions from 1977 to 2000 · 2 indication expansions
May 2000 SUPPL
Label · Labeling
Nov 1998 SUPPL
Label · Labeling
Jul 1998 SUPPL Priority
Mfg · Manufacturing (CMC)

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

NORPACE Competitive Set

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Drugs Similar to NORPACE

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PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE
2 shared
SINOTHERAPEUTICS INC
Shared indications:
Ventricular TachycardiaVentricular Arrhythmias
SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDE
2 shared
IMPAX PHARMS
Shared indications:
Ventricular ArrhythmiasVentricular Tachycardia
FLECAINIDE ACETATE
FLECAINIDE ACETATE
1 shared
Aurobindo Pharma
Shared indications:
Ventricular Tachycardia
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Active Pipeline

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Key Completed Trials

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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

Indications & Usage

NORPACE is indicated for the treatment of Ventricular Tachycardia; Ventricular Arrhythmias.

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Data Sources

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