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Last Updated: August 11, 2022

Details for New Drug Application (NDA): 211888


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NDA 211888 describes ALBUTEROL SULFATE, which is a drug marketed by Cipla, Lupin, Padagis Us, Sandoz Inc, Actavis Mid Atlantic, Akorn, Apotex Inc, Bausch, Copley Pharm, Landela Pharm, Luoxin Aurovitas, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, Chartwell Molecular, Chartwell Rx, Cosette, Mova, Quagen, Teva, Rising, Am Therap, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Eywa, Mylan, 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 NDAs. It is available from thirty-one 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 211888
Tradename:ALBUTEROL SULFATE
Applicant:Luoxin Aurovitas
Ingredient:albuterol sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211888
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 211888
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 211888 ANDA Aurobindo Pharma Limited 59651-183 59651-183-25 25 POUCH in 1 CARTON (59651-183-25) > 5 VIAL in 1 POUCH (59651-183-05) > 3 mL in 1 VIAL
ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 211888 ANDA Aurobindo Pharma Limited 59651-184 59651-184-25 25 POUCH in 1 CARTON (59651-184-25) > 5 VIAL in 1 POUCH (59651-184-05) > 3 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INHALATIONStrengthEQ 0.021% BASE
Approval Date:Apr 20, 2020TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INHALATIONStrengthEQ 0.042% BASE
Approval Date:Apr 20, 2020TE:RLD:No

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