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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210948


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NDA 210948 describes ALBUTEROL SULFATE, which is a drug marketed by Armstrong Pharms, Cipla, Lupin, Padagis Us, Sandoz, Actavis Mid Atlantic, Apotex Inc, Bausch, Copley Pharm, Epic Pharma Llc, Landela Pharm, Lexenpharm, Luoxin Aurovitas, Nephron, Norvium Bioscience, Ritedose Corp, Roxane, Sentiss, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, Chartwell Molecular, Chartwell Rx, Cosette, Hikma, Mova, Quagen, Teva, Rising, Aizant, Am Therap, Amneal Pharms Co, Aurobindo Pharma Ltd, Dash Pharms Natco, Eywa, Pliva, Strides Pharma, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Fosun Pharma, and Watson Labs Teva, and is included in eighty-two NDAs. It is available from forty 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. Fifteen 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:Aizant
Ingredient:albuterol sulfate
Patents:0
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 Nivagen Pharmaceuticals Inc 75834-273 75834-273-01 100 TABLET in 1 BOTTLE, PLASTIC (75834-273-01)
ALBUTEROL SULFATE albuterol sulfate TABLET;ORAL 210948 ANDA Nivagen Pharmaceuticals Inc 75834-274 75834-274-01 100 TABLET in 1 BOTTLE, PLASTIC (75834-274-01)

Profile for product number 001

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

Profile for product number 002

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

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