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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Julphar
Cerilliant
Accenture
Farmers Insurance
UBS
Deloitte
Mallinckrodt
Citi

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076355

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NDA 076355 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, 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-seven 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 076355
Tradename:ALBUTEROL SULFATE
Applicant:Nephron
Ingredient:albuterol sulfate
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076355
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 076355
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 076355 ANDA Nephron Pharmaceuticals Corporation 0487-0301 N 0487-0301-01
ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 076355 ANDA Nephron Pharmaceuticals Corporation 0487-0301 N 0487-0301-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.042% BASE
Approval Date:Jun 28, 2004TE:ANRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.021% BASE
Approval Date:Mar 31, 2010TE:ANRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Accenture
Moodys
Johnson and Johnson
Citi
Fish and Richardson
Cipla
Dow
Medtronic

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