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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 are two patents 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. Seven suppliers are listed for this compound.

Summary for Generic Name: levalbuterol hydrochloride

Tradenames:2
Patents:2
Applicants:6
NDAs:7
Drug Master File Entries: see list9
Suppliers: see list7
Therapeutic Class:Respiratory Tract Agents

Pharmacology for Ingredient: levalbuterol hydrochloride

Clinical Trials for: levalbuterol hydrochloride

Adding Nebulized Salbutamol to Intravenous Atropine and Oxygen in OP Poisoning
Status: Not yet recruiting Condition: Salbutamol; Organophosphate Poisoning; Atropine

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

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

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

A Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
Status: Completed Condition: Asthma

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
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;INHALATION020837Mar 25, 1999RXYes5,547,994<disabled><disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837Jan 30, 2002RXYes6,451,289<disabled><disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837Jul 18, 2003RXYes6,451,289<disabled>Y<disabled>
Mylan Speclt
LEVALBUTEROL HYDROCHLORIDE
levalbuterol hydrochloride
SOLUTION;INHALATION077800Mar 15, 2013RXNo<disabled><disabled>
Watson Labs Inc
LEVALBUTEROL HYDROCHLORIDE
levalbuterol hydrochloride
SOLUTION;INHALATION077756Apr 9, 2008RXNo<disabled><disabled>
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