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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 214531


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NDA 214531 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, Hibrow Hlthcare, Pliva, Strides Pharma, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Aiping Pharm Inc, 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 214531
Tradename:ALBUTEROL SULFATE
Applicant:Ritedose Corp
Ingredient:albuterol sulfate
Patents:0
Pharmacology for NDA: 214531
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 214531
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 214531 ANDA Mylan Pharmaceuticals Inc. 0378-7057 0378-7057-52 5 POUCH in 1 CARTON (0378-7057-52) / 5 VIAL in 1 POUCH (0378-7057-98) / 3 mL in 1 VIAL
ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 214531 ANDA Mylan Pharmaceuticals Inc. 0378-7058 0378-7058-52 5 POUCH in 1 CARTON (0378-7058-52) / 5 VIAL in 1 POUCH (0378-7058-98) / 3 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.021% BASE
Approval Date:Dec 28, 2021TE:ANRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.042% BASE
Approval Date:Dec 28, 2021TE:ANRLD:No

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