TheraRadar
Data updated: May 26, 2026

LABETALOL HYDROCHLORIDE IN DEXTROSE (labetalol hydrochloride)

Cardiovascular Approved 2020-11-09

LABETALOL HYDROCHLORIDE IN DEXTROSE is indicated for the treatment of Hypertension.

Source: FDA Label • Hikma
1
Indication
--
Phase 3 Trials
5
Years on Market

Details

Status
Prescription
First Approved
2020-11-09
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: LABETALOL HYDROCHLORIDE

LABETALOL HYDROCHLORIDE IN DEXTROSE Approval History

2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2020 to 2024
Aug 2024 SUPPL
Mfg · Manufacturing (CMC)
Jun 2023 SUPPL
Label · Labeling
Mar 2022 SUPPL
Mfg · Manufacturing (CMC)

What LABETALOL HYDROCHLORIDE IN DEXTROSE Treats

1 indications

LABETALOL HYDROCHLORIDE IN DEXTROSE is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
Source: FDA Label

LABETALOL HYDROCHLORIDE IN DEXTROSE Competitive Set

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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.

LABETALOL HYDROCHLORIDE IN DEXTROSE FDA Label Details

Indications & Usage

FDA Label (PDF)

LABETALOL HYDROCHLORIDE IN DEXTROSE is indicated for the treatment of Hypertension.

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Data Sources

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