Last Updated: June 17, 2026

Details for New Drug Application (NDA): 073533

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NDA 073533 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, Hibrow Hlthcare, Natco Pharma Usa, 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-five NDAs. It is available from forty 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. Fourteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.

Summary for 073533

Tradename:	ALBUTEROL SULFATE
Applicant:	Actavis Mid Atlantic
Ingredient:	albuterol sulfate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INHALATION			Strength	EQ 0.083% BASE
Approval Date:	Sep 26, 1995	TE:		RLD:	No

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