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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 072273

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NDA 072273 describes ALBUTEROL, which is a drug marketed by Armstrong Pharms, Genpharm, Ivax Sub Teva Pharms, Pliva, Amneal Ireland Ltd, 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, Strides Pharma Intl, Sun Pharm Industries, Ucb Inc, Warner Chilcott, Zydus Pharms, Aiping Pharm Inc, and Watson Labs Teva, and is included in eighty-eight NDAs. Additional details are available on the ALBUTEROL profile page.

The generic ingredient in ALBUTEROL 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 072273

Tradename:	ALBUTEROL
Applicant:	Armstrong Pharms
Ingredient:	albuterol
Patents:	0

Medical Subject Heading (MeSH) Categories for 072273

Adrenergic beta-2 Receptor Agonists
Bronchodilator Agents
Tocolytic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	AEROSOL, METERED;INHALATION			Strength	0.09MG/INH
Approval Date:	Aug 14, 1996	TE:		RLD:	No

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