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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 212447

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NDA 212447 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, 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, Pliva, 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-two 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. Fifteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.

Summary for 212447

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

Pharmacology for NDA: 212447

Mechanism of Action	Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 212447

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALBUTEROL SULFATE	albuterol sulfate	AEROSOL, METERED;INHALATION	212447	ANDA	Armstrong Pharmaceuticals, Inc.	17270-0740	17270-0740-0	1 INHALER in 1 CARTON (17270-0740-0) / 200 INHALANT in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	EQ 0.09MG BASE/INH
Approval Date:	May 21, 2024	TE:	AB2	RLD:	No

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