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Details for Generic Name: levalbuterol hydrochloride

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Levalbuterol hydrochloride is the generic ingredient in two branded drugs marketed by Cipla Ltd, Mylan Speclt, Teva Parenteral, Teva Pharms Usa, Watson Labs Inc, and Oak Pharms Inc, and is included in seven NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for levalbuterol hydrochloride. Nine suppliers are listed for this compound.

Summary for Generic Name: levalbuterol hydrochloride

Tradenames:2
Patents:1
Applicants:6
NDAs:7
Drug Master File Entries: see list9
Suppliers: see list9
Therapeutic Class:Respiratory Tract Agents

Pharmacology for Ingredient: levalbuterol hydrochloride

Clinical Trials for: levalbuterol hydrochloride

Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate
Status: Completed Condition: Healthy Volunteers

Salbutamol, Pharmacogenetics and Breathing Mechanics
Status: Active, not recruiting Condition: Exercise-induced Bronchoconstriction,; Inhaled Salbutamol; Cycling Performance

Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients
Status: Completed Condition: Asthma

Preterm Infant Inhaled Albuterol Dosing
Status: Recruiting Condition: Bronchopulmonary Dysplasia; Very Low Birth Weight

Continuous Levalbuterol for Treatment of Status Asthmaticus in Children
Status: Completed Condition: Asthma

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-002Mar 25, 1999RXYes<disabled><disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-003Jan 30, 2002RXYes<disabled><disabled>
Cipla Ltd
LEVALBUTEROL HYDROCHLORIDE
levalbuterol hydrochloride
SOLUTION;INHALATION078171-001Dec 13, 2013RXNo<disabled><disabled>
Teva Pharms Usa
LEVALBUTEROL HYDROCHLORIDE
levalbuterol hydrochloride
SOLUTION;INHALATION090297-001Apr 26, 2013RXNo<disabled><disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837-002Mar 25, 1999RXYes6,451,289<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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