Data updated: Mar 10, 2026
LABETALOL HYDROCHLORIDE
LABETALOL HYDROCHLORIDE
Approved 1998-08-03
23
Indications
--
Phase 3 Trials
27
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1998-08-03
- Routes
- INJECTION, ORAL, INTRAVENOUS
- Dosage Forms
- INJECTABLE, TABLET, SOLUTION
Companies
ONESOURCE SPECIALTY Baxter APPCO APOTHECON HIBROW HLTHCARE AMNEAL Teva Hikma PH HEALTH ZYDUS PHARMS EPIC PHARMA LLC WATSON LABS ANDAS 5 HOLDING CAPLIN RISING GLAND PHARMA LTD AIPING PHARM INC RUBICON RESEARCH MACLEODS PHARMS LTD Pfizer CADILA PHARMS LTD HERITAGE PHARMA UNICHEM
Active Ingredient: LABETALOL HYDROCHLORIDE
Website: ↗
LABETALOL HYDROCHLORIDE Approval History
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What LABETALOL HYDROCHLORIDE Treats
23 FDA approvalsOriginally approved for its first indication in 1998 . Covers 23 distinct patient populations.
- Other (23)
Other
(23 approvals)- • Approved indication (Aug 1998)Letter
- • Approved indication (Aug 1998)Letter
- • Approved indication (Sep 1998)Letter
- • Approved indication (Nov 1998)Letter
- • Approved indication (May 1999)Letter
- • Approved indication (Jul 1999)Letter
- • Approved indication (Sep 1999)Letter
- • Approved indication (Nov 1999)Letter
- • Approved indication (Jul 2002)
- • Approved indication (Feb 2010)
- • Approved indication (Apr 2012)
- • Approved indication (Jul 2012)
- • Approved indication (Sep 2017)
- • Approved indication (Jun 2018)
- • Approved indication (Feb 2019)
- • Approved indication (May 2019)
- • Approved indication (Sep 2020)
- • Approved indication (Nov 2020)Label Letter
- • Approved indication (Aug 2021)
- • Approved indication (Sep 2021)
- • Approved indication (Aug 2022)
- • Approved indication (Sep 2025) New
- • Approved indication (Oct 2025) New
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
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.
LABETALOL HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.