Last Updated: June 27, 2026

Details for New Drug Application (NDA): 072151

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NDA 072151 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 072151

Tradename:	ALBUTEROL SULFATE
Applicant:	Chartwell Rx
Ingredient:	albuterol sulfate
Patents:	0

Pharmacology for NDA: 072151

Mechanism of Action	Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 072151

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072151	ANDA	Chartwell RX, LLC	62135-671	62135-671-90	90 TABLET in 1 BOTTLE (62135-671-90)
ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072151	ANDA	Chartwell RX, LLC	62135-672	62135-672-90	90 TABLET in 1 BOTTLE (62135-672-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2MG BASE
Approval Date:	Dec 5, 1989	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 4MG BASE
Approval Date:	Dec 5, 1989	TE:		RLD:	No

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