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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 073045

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NDA 073045 describes ALBUTEROL, which is a drug marketed by Armstrong Pharms, Genpharm, Ivax Sub Teva Pharms, Pliva, Cipla, Lupin, Padagis Us, Sandoz, Actavis Mid Atlantic, Apotex Inc, Bausch, Copley Pharm, Epic Pharma Llc, Landela Pharm, Lexenpharm, Luoxin Aurovitas, Nephron, Norvium Bioscience, 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, Aizant, Am Therap, Amneal Pharms Co, Aurobindo Pharma Ltd, Dash Pharms Natco, Hibrow Hlthcare, Strides Pharma, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Aiping Pharm Inc, and Watson Labs Teva, and is included in eighty-six 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 073045

Tradename:	ALBUTEROL
Applicant:	Genpharm
Ingredient:	albuterol
Patents:	0

Medical Subject Heading (MeSH) Categories for 073045

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 19, 1997	TE:		RLD:	No

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