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Details for Generic Name: albuterol sulfate

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Albuterol sulfate is the generic ingredient in fourteen branded drugs marketed by Teva Branded Pharm, 3M, Glaxosmithkline, Mylan Speclt, Actavis Mid Atlantic, Apotex Inc, Bausch And Lomb, Copley Pharm, Hi Tech Pharma, Landela Pharm, Nephron, Ritedose Corp, Roxane, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Schering, Amneal Pharms, Mova, Teva, Vintage, Vistapharm, Mylan, Muro, Dava Pharms Inc, Am Therap, Mutual Pharm, Pliva, Sandoz, Ucb Inc, Warner Chilcott, Boehringer Ingelheim, Cipla Ltd, and Sandoz Inc, and is included in eigthy-two NDAs. There are fourty-four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are thirty-four drug master file entries for albuterol sulfate. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: albuterol sulfate

Drug Master File Entries: see list34
Suppliers: see list18
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: albuterol sulfate

Tentative approvals for ALBUTEROL SULFATE

Applicant Application No. Form Dosage

Clinical Trials for: albuterol sulfate

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

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

Inhaled Albuterol Sulfate For Acute Wheezing Due To Obstructive Airways Disease In Children
Status: Completed Condition: Airway Disease; Asthma; Acute Wheezing

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

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

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

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 2001RXYes6,938,796*PED<disabled>Y<disabled>
Copley Pharm
albuterol sulfate
SOLUTION;INHALATION073307-001Nov 27, 1991DISCNNo<disabled><disabled>
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 2001RXYes7,832,351*PED<disabled>Y<disabled>
Boehringer Ingelheim
albuterol sulfate; ipratropium bromide
SPRAY, METERED;INHALATION021747-001Oct 7, 2011RXYes7,896,264<disabled>Y<disabled>
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 2001RXYes6,743,413*PED<disabled>Y<disabled>
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Preferred citation:

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

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