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Serving leading biopharmaceutical companies globally:

US Department of Justice
Queensland Health
QuintilesIMS
Express Scripts
Citi
Dow
Moodys
Healthtrust
Mallinckrodt
Harvard Business School

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077839

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NDA 077839 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, Mova, Teva, Vintage, Vistapharm, Mylan, Am Therap, Dava Pharms Inc, Pliva, Sandoz, Sun Pharm Industries, Ucb Inc, Warner Chilcott, Cipla Ltd, Sandoz Inc, and Watson Labs Teva, and is included in sixty-six NDAs. It is available from thirty-five 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 077839
Tradename:ALBUTEROL SULFATE
Applicant:Ritedose Corp
Ingredient:albuterol sulfate
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077839
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 077839
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 077839 ANDA Mylan Pharmaceuticals, Inc. 0378-8270 0378-8270-52 1 POUCH in 1 CARTON (0378-8270-52) > 25 AMPULE in 1 POUCH (0378-8270-62) > 3 mL in 1 AMPULE
ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 077839 ANDA Mylan Pharmaceuticals, Inc. 0378-8270 0378-8270-91 2 POUCH in 1 CARTON (0378-8270-91) > 30 AMPULE in 1 POUCH (0378-8270-64) > 3 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.083% BASE
Approval Date:Dec 16, 2008TE:ANRLD:No

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Serving leading biopharmaceutical companies globally:

Moodys
Dow
McKesson
AstraZeneca
Harvard Business School
Chubb
Mallinckrodt
Farmers Insurance
Accenture

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