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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 203760

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NDA 203760 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-three 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 203760

Tradename:	ALBUTEROL SULFATE
Applicant:	Padagis Us
Ingredient:	albuterol sulfate
Patents:	0

Pharmacology for NDA: 203760

Mechanism of Action	Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 203760

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALBUTEROL SULFATE	albuterol sulfate	AEROSOL, METERED;INHALATION	203760	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-088	45802-088-01	1 INHALER in 1 CARTON (45802-088-01) / 200 AEROSOL, METERED in 1 INHALER
ALBUTEROL SULFATE	albuterol sulfate	AEROSOL, METERED;INHALATION	203760	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1513	51662-1513-1	1 INHALER in 1 CARTON (51662-1513-1) / 200 AEROSOL, METERED in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	EQ 0.09MG BASE/INH
Approval Date:	Feb 24, 2020	TE:	AB2	RLD:	No

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