Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 13, 2019

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 Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, G And W Labs Inc, Lannett Co Inc, Mova, Quagen, Teva, Vistapharm, Mylan, Am Therap, Amneal Pharms Co, Appco Pharma Llc, Arise, Dava Pharms Inc, Pliva, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Yaopharma Co Ltd, Cipla, Fosun Pharma, and Watson Labs Teva, and is included in seventy-one 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. Thirteen 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
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 0472-0825-04 118 mL in 1 BOTTLE (0472-0825-04)
ALBUTEROL SULFATE albuterol sulfate SYRUP;ORAL 074454 ANDA Actavis Pharma, Inc. 0472-0825 0472-0825-16 473 mL in 1 BOTTLE (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 leading biopharmaceutical companies globally:

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Mallinckrodt
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Harvard Business School

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