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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 211397

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NDA 211397 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 211397

Tradename:	ALBUTEROL SULFATE
Applicant:	Acertis Pharms
Ingredient:	albuterol sulfate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2MG BASE
Approval Date:	Oct 26, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 4MG BASE
Approval Date:	Oct 26, 2018	TE:	AB	RLD:	No

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