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Chubb
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Generated: June 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074543

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NDA 074543 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 074543
Tradename:ALBUTEROL SULFATE
Applicant:Hi Tech Pharma
Ingredient:albuterol sulfate
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074543
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 074543
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 074543 ANDA Rebel Distributors Corp. 21695-245 E 21695-245-20
ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 074543 ANDA A-S Medication Solutions 50090-0517 N 50090-0517-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.5% BASE
Approval Date:Jan 15, 1998TE:ANRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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Cantor Fitzgerald
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US Department of Justice
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