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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 209954

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NDA 209954 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 209954

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

Pharmacology for NDA: 209954

Mechanism of Action	Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 209954

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALBUTEROL SULFATE	albuterol sulfate	AEROSOL, METERED;INHALATION	209954	ANDA	A-S Medication Solutions	50090-5231	50090-5231-0	1 CANISTER in 1 CARTON (50090-5231-0) / 200 AEROSOL, METERED in 1 CANISTER
ALBUTEROL SULFATE	albuterol sulfate	AEROSOL, METERED;INHALATION	209954	ANDA	NuCare Pharmaceuticals,Inc.	68071-2300	68071-2300-2	1 CANISTER in 1 CARTON (68071-2300-2) / 200 AEROSOL, METERED in 1 CANISTER

Profile for product number 001

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

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