TheraRadar
Data updated: May 26, 2026

ACEBUTOLOL HYDROCHLORIDE

Cardiovascular Approved 1995-04-24

ACEBUTOLOL HYDROCHLORIDE is indicated for the treatment of Hypertension; Ventricular Arrhythmia.

Source: FDA Label • PHARMOBEDIENT
3
Indications
--
Phase 3 Trials
31
Years on Market

Details

Status
Discontinued
First Approved
1995-04-24
Routes
ORAL
Dosage Forms
CAPSULE

ACEBUTOLOL HYDROCHLORIDE Approval History

1996
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Original
New Indication
New Form
Label Update
42 FDA actions from 1995 to 2015
Apr 2015 SUPPL
Label · Labeling
Mar 2014 SUPPL
Mfg · Manufacturing (CMC)
Mar 2014 SUPPL
Label · Labeling

What ACEBUTOLOL HYDROCHLORIDE Treats

2 indications

ACEBUTOLOL HYDROCHLORIDE is approved for 2 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Ventricular Arrhythmia
Source: FDA Label

ACEBUTOLOL HYDROCHLORIDE Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to ACEBUTOLOL HYDROCHLORIDE

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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.

ACEBUTOLOL HYDROCHLORIDE FDA Label Details

Indications & Usage

ACEBUTOLOL HYDROCHLORIDE is indicated for the treatment of Hypertension; Ventricular Arrhythmia.

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Data Sources

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