Data updated: Mar 10, 2026
PROCAINAMIDE HYDROCHLORIDE
PROCAINAMIDE HYDROCHLORIDE
Approved 1976-12-02
24
Indications
--
Phase 3 Trials
49
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1976-12-02
- Routes
- ORAL, INJECTION
- Dosage Forms
- CAPSULE, INJECTABLE, TABLET, EXTENDED RELEASE
Companies
IVAX SUB TEVA PHARMS LEDERLE SOLOPAK INTL MEDICATION Hikma Novartis IDT AUSTRALIA LTD LANNETT WATSON LABS ABRAXIS PHARM ANI PHARMS Pfizer ASCOT PHARMAFAIR INWOOD LABS GLAND VANGARD WARNER CHILCOTT CAPLIN NEXUS SMITH AND NEPHEW ROXANE WEST-WARD PHARMS INT
Active Ingredient: PROCAINAMIDE HYDROCHLORIDE
Website: ↗
PROCAINAMIDE HYDROCHLORIDE Approval History
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What PROCAINAMIDE HYDROCHLORIDE Treats
24 FDA approvalsOriginally approved for its first indication in 1976 . Covers 24 distinct patient populations.
- Other (24)
Other
(24 approvals)- • Approved indication (Dec 1976)
- • Approved indication (May 1977)
- • Approved indication (Jun 1977)
- • Approved indication (Jun 1977)
- • Approved indication (Jun 1977)
- • Approved indication (Jul 1980)
- • Approved indication (Jun 1982)
- • Approved indication (Jul 1984)
- • Approved indication (Jul 1985)
- • Approved indication (Oct 1985)
- • Approved indication (Dec 1985)
- • Approved indication (Feb 1986)
- • Approved indication (Apr 1986)
- • Approved indication (Jun 1986)
- • Approved indication (Jul 1986)
- • Approved indication (Nov 1986)
- • Approved indication (Jan 1987)
- • Approved indication (Mar 1987)
- • Approved indication (Aug 1987)
- • Approved indication (Dec 1996)
- • Approved indication (Jul 2004)
- • Approved indication (Oct 2017)
- • Approved indication (Jul 2024)
- • Approved indication (Feb 2025)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
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.
PROCAINAMIDE HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.