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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 215571

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NDA 215571 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, Pharmobedient, 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, Acertis Pharms, Aizant, Am Therap, Amneal Pharms Co, Aurobindo Pharma Ltd, Dash Pharms Natco, Hibrow Hlthcare, Pliva, Strides Pharma Intl, Sun Pharm Industries, Ucb Inc, Warner Chilcott, Zydus Pharms, Aiping Pharm Inc, and Watson Labs Teva, and is included in eighty-three NDAs. It is available from forty-two 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. Sixteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.

Summary for 215571

Tradename:	ALBUTEROL SULFATE
Applicant:	Lexenpharm
Ingredient:	albuterol sulfate
Patents:	0

Pharmacology for NDA: 215571

Mechanism of Action	Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 215571

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALBUTEROL SULFATE	albuterol sulfate	SOLUTION;INHALATION	215571	ANDA	Ingenus Pharmaceuticals, LLC	50742-392	50742-392-25	5 POUCH in 1 CARTON (50742-392-25) / 5 VIAL in 1 POUCH (50742-392-05) / 3 mL in 1 VIAL
ALBUTEROL SULFATE	albuterol sulfate	SOLUTION;INHALATION	215571	ANDA	Ingenus Pharmaceuticals, LLC	50742-393	50742-393-25	5 POUCH in 1 CARTON (50742-393-25) / 5 VIAL in 1 POUCH (50742-393-05) / 3 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	EQ 0.021% BASE
Approval Date:	May 3, 2024	TE:	AN	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	EQ 0.042% BASE
Approval Date:	May 3, 2024	TE:	AN	RLD:	No

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