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Profile for Tradename: XOPENEX

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Summary for Tradename: XOPENEX

Patents:6
Applicants:2
NDAs:2
Suppliers: see list7

Pharmacology for Tradename: XOPENEX

Clinical Trials for: XOPENEX

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

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

Single-Dose Cross-Over Study of the Effects of Albuterol-HFA in Exercise Induced Bronchoconstriction
Status: Terminated Condition: Asthma; Bronchospasm

The Various Effects of Gaseous Albuterol on Serum Lactate
Status: Not yet recruiting Condition: Asthma

Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED)
Status: Completed Condition: Asthma

Safety and Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatrics Subjects With Asthma
Status: Completed Condition: Asthma

Courtesy of ClinicalTrials.org
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Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730Mar 11, 2005RXYes5,836,299<disabled>Y<disabled>
Sunovion
XOPENEX HFA
levalbuterol tartrate
AEROSOL, METERED;INHALATION021730Mar 11, 2005RXYes5,605,674<disabled>Y<disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837Jan 30, 2002RXYes5,547,994<disabled><disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837Mar 25, 1999RXYes6,451,289<disabled><disabled>
Oak Pharms Inc
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION020837Jul 18, 2003RXYes6,451,289<disabled>Y<disabled>
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Paragraph IV activity for: XOPENEX

Drugname Dosage Strength RLD Submissiondate
levalbuterol tartrateInhalation Aerosol0.045 mg/actuationXopenex2/27/2012
levalbuterol hydrochlorideInhalation Solution0.0025Xopenex5/23/2006
levalbuterol hydrochlorideInhalation Solution0.0103%, 0.021% and 0.042%Xopenex6/20/2005
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