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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 207046

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NDA 207046 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-three 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 207046

Tradename:	ALBUTEROL SULFATE
Applicant:	Rising
Ingredient:	albuterol sulfate
Patents:	0

Pharmacology for NDA: 207046

Mechanism of Action	Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 207046

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	207046	ANDA	Bryant Ranch Prepack	63629-2611	63629-2611-1	20 TABLET in 1 BOTTLE (63629-2611-1)
ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	207046	ANDA	Bryant Ranch Prepack	63629-2611	63629-2611-2	30 TABLET in 1 BOTTLE (63629-2611-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2MG BASE
Approval Date:	Jun 29, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 4MG BASE
Approval Date:	Jun 29, 2018	TE:	AB	RLD:	No

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