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Data updated: Jun 28, 2026

LEVALBUTEROL HYDROCHLORIDE · MANKIND PHARMA

Generic · see XOPENEX
Respiratory Approved 1999-03-25

Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
12
Indications
--
Phase 3 Trials
27
Years on Market

Details

Status
Discontinued
First Approved
1999-03-25
Routes
INHALATION
Dosage Forms
SOLUTION

Companies

MANKIND PHARMA Teva Sun Pharma Cipla LUOXIN AUROVITAS NEPHRON IMPAX LABS RITEDOSE CORP PHARMOBEDIENT Viatris
Active Ingredient: LEVALBUTEROL HYDROCHLORIDE

LEVALBUTEROL HYDROCHLORIDE Approval History

2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
81 FDA actions from 2008 to 2026
May 2026 ORIGINAL
Update
Oct 2024 ORIGINAL
Update
Apr 2023 SUPPL
Label · Labeling

What LEVALBUTEROL HYDROCHLORIDE Treats

2 indications

LEVALBUTEROL HYDROCHLORIDE is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Bronchospasm
  • Obstructive Airway Disease
Source: FDA Label

LEVALBUTEROL HYDROCHLORIDE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

9

Same indication, different mechanism — what else might this patient receive?

AIRDUO RESPICLICK
Teva
2017 2 indic.
PROAIR RESPICLICK
Teva
2015 3 indic.
Unlock 7 more competitors across all three rings.
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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 LEVALBUTEROL HYDROCHLORIDE

3 of 9

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
ALBUTEROL SULFATE
2 shared
NEPHRON
Shared indications:
BronchospasmObstructive Airway Disease
PROAIR HFA
ALBUTEROL SULFATE
2 shared
Teva
Shared indications:
BronchospasmObstructive Airway Disease
PROAIR RESPICLICK
ALBUTEROL SULFATE
2 shared
Teva
Shared indications:
BronchospasmObstructive Airway Disease
View all 9 similar drugs Pro
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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

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.

LEVALBUTEROL HYDROCHLORIDE FDA Label Details

Indications & Usage

Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. Levalbuterol Inhalation Solution, USP is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.

Looking for the branded version?

XOPENEX

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

See XOPENEX

Data Sources

FDA Approval: ANDA218770 → Label: DailyMed → Trials: ClinicalTrials.gov →

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