TheraRadar
Data updated: May 26, 2026

DOBUTAMINE HYDROCHLORIDE

Cardiovascular Approved 1993-10-19

DOBUTAMINE HYDROCHLORIDE is indicated for the treatment of Cardiac Decompensation; Heart Disease; Congestive Heart Failure.

Source: FDA Label • Pfizer
12
Indications
--
Phase 3 Trials
32
Years on Market

Details

Status
Prescription
First Approved
1993-10-19
Routes
INJECTION
Dosage Forms
INJECTABLE

DOBUTAMINE HYDROCHLORIDE Approval History

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Original
New Indication
New Form
Label Update
59 FDA actions from 1993 to 2024
Mar 2024 SUPPL
Label · Labeling
Dec 2022 ORIGINAL
Update
Dec 2002 SUPPL
Mfg · Manufacturing (CMC)

What DOBUTAMINE HYDROCHLORIDE Treats

3 indications

DOBUTAMINE HYDROCHLORIDE is approved for 3 conditions since its original approval in 1993. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Cardiac Decompensation
  • Heart Disease
  • Congestive Heart Failure
Source: FDA Label

DOBUTAMINE 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 DOBUTAMINE HYDROCHLORIDE

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DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
DOBUTAMINE HYDROCHLORIDE
3 shared
Baxter
Shared indications:
Cardiac DecompensationHeart DiseaseCongestive Heart Failure
ACETAZOLAMIDE
ACETAZOLAMIDE
1 shared
Sun Pharma
Shared indications:
AMILORIDE HYDROCHLORIDE
AMILORIDE HYDROCHLORIDE
1 shared
CHARTWELL RX
Shared indications:
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT04893655 DOBU whipple BC-08919 Ph 4 completed Effect of Dobutamine on Hepatic Blood Flow During Goal-directed Hemodynamic Therapy
NCT03098680 PRIME PRIME (A094136) Ph 1 terminated A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems
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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

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.

DOBUTAMINE HYDROCHLORIDE FDA Label Details

Indications & Usage

DOBUTAMINE HYDROCHLORIDE is indicated for the treatment of Cardiac Decompensation; Heart Disease; Congestive Heart Failure.

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DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Full clinical data, patents, trials, and competitive landscape for dobutamine hydrochloride.

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Data Sources

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