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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 207085

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NDA 207085 describes ALBUTEROL SULFATE, which is a drug marketed by Amneal Ireland Ltd, 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-four NDAs. It is available from forty-one 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 207085

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

Pharmacology for NDA: 207085

Mechanism of Action	Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 207085

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALBUTEROL SULFATE	albuterol sulfate	AEROSOL, METERED;INHALATION	207085	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0742	0054-0742-87	1 CANISTER in 1 CARTON (0054-0742-87) / 200 AEROSOL, METERED in 1 CANISTER
ALBUTEROL SULFATE	albuterol sulfate	AEROSOL, METERED;INHALATION	207085	ANDA	Preferred Pharmaceuticals Inc.	68788-8787	68788-8787-2	1 CANISTER in 1 CARTON (68788-8787-2) / 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:	Jun 1, 2021	TE:	AB1	RLD:	No

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