LABETALOL HYDROCHLORIDE IN DEXTROSE (labetalol hydrochloride) · Hikma
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.
Details
- Status
- Prescription
- First Approved
- 2020-11-09
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
LABETALOL HYDROCHLORIDE IN DEXTROSE Approval History
What LABETALOL HYDROCHLORIDE IN DEXTROSE Treats
1 indicationsLABETALOL 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.
LABETALOL HYDROCHLORIDE IN DEXTROSE Competitive Set
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Indication competitors
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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.
What's emerging in LABETALOL HYDROCHLORIDE IN DEXTROSE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LABETALOL HYDROCHLORIDE IN DEXTROSE treats. First-in-class if their pivotal trials read out positive.
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Active Pipeline
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Trial Timeline
Full development history with FDA approval milestones
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 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
Data sourced from official FDA and NIH databases. Click links to verify on original sources.