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Last Updated: February 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210948


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NDA 210948 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, Cosette, Lannett Co Inc, Mova, Quagen, Teva, Vistapharm, Mylan, Am Therap, Amneal Pharms Co, Appco, 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-four 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. Fourteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
Summary for 210948
Tradename:ALBUTEROL SULFATE
Applicant:Arise
Ingredient:albuterol sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210948
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 210948
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 210948 ANDA Dash Pharmaceutical LLC 69339-126 69339-126-01 100 TABLET in 1 BOTTLE, PLASTIC (69339-126-01)
ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 210948 ANDA Dash Pharmaceutical LLC 69339-127 69339-127-01 100 TABLET in 1 BOTTLE, PLASTIC (69339-127-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Mar 15, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Mar 15, 2019TE:ABRLD:No

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