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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Chinese Patent Office
Boehringer Ingelheim
Chubb
US Department of Justice
Argus Health
QuintilesIMS
Harvard Business School
Cipla

Generated: July 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074454

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NDA 074454 describes ALBUTEROL SULFATE, which is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Hi Tech Pharma, Landela Pharm, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sun Pharma Global, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, G And W Labs Inc, Lannett Co Inc, Mova, Teva, Vistapharm, Mylan, Am Therap, Amneal Pharms Co, Appco Pharma Llc, Dava Pharms Inc, Pliva, Sun Pharm Industries, Ucb Inc, Warner Chilcott, Yaopharma Co Ltd, Cipla Ltd, Fosun Pharma, and Watson Labs Teva, and is included in sixty-eight NDAs. It is available from thirty-eight suppliers. Additional details are available on the ALBUTEROL SULFATE profile page.

The generic ingredient in ALBUTEROL SULFATE is albuterol sulfate; ipratropium bromide. There are thirty-eight drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
Summary for 074454
Tradename:ALBUTEROL SULFATE
Applicant:G And W Labs Inc
Ingredient:albuterol sulfate
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074454
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 074454
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALBUTEROL SULFATE albuterol sulfate SYRUP;ORAL 074454 ANDA Actavis Pharma, Inc. 0472-0825 N 0472-0825-04
ALBUTEROL SULFATE albuterol sulfate SYRUP;ORAL 074454 ANDA Actavis Pharma, Inc. 0472-0825 N 0472-0825-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrengthEQ 2MG BASE/5ML
Approval Date:Sep 25, 1995TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Teva
US Army
Citi
Express Scripts
Harvard Business School
Covington
Merck
Cipla

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