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Last Updated: June 25, 2021

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Details for New Drug Application (NDA): 074543

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NDA 074543 describes ALBUTEROL SULFATE, which is a drug marketed by Cipla, Lupin, Perrigo Pharms Co, Actavis Mid Atlantic, Akorn, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Landela Pharm, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, Chartwell Rx, Cosette, Lannett Co Inc, Mova, Quagen, Teva, Mylan, Aizant, Am Therap, Amneal Pharms Co, Dava Pharms Inc, Eywa, Pliva, Rising, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Yaopharma Co Ltd, Zydus Pharms, Fosun Pharma, and Watson Labs Teva, and is included in seventy-nine NDAs. It is available from thirty 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. Twelve suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
Summary for 074543
Ingredient:albuterol sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 074543
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 074543
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 074543 ANDA A-S Medication Solutions 50090-0517 50090-0517-0 1 BOTTLE, GLASS in 1 CARTON (50090-0517-0) > 20 mL in 1 BOTTLE, GLASS
ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 074543 ANDA Hi-Tech Pharmacal Co., Inc. 50383-741 50383-741-20 1 BOTTLE, GLASS in 1 CARTON (50383-741-20) > 20 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.5% BASE
Approval Date:Jan 15, 1998TE:ANRLD:No

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