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Data updated: Mar 10, 2026

LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE

LABETALOL HYDROCHLORIDE
Cardiovascular Approved 2020-11-09
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
5
Years on Market

Details

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

Companies

Hikma
Active Ingredient: LABETALOL HYDROCHLORIDE

LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE Approval History

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What LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE Treats

1 indications

LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE 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

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Active Pipeline

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Key Completed Trials

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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 SODIUM CHLORIDE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Labetalol hydrochloride tablets USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.

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Data Sources

FDA Approval: NDA213330 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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