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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 212197

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NDA 212197 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 212197

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

Pharmacology for NDA: 212197

Mechanism of Action	Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 212197

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALBUTEROL SULFATE	albuterol sulfate	SYRUP;ORAL	212197	ANDA	Preferred Pharmaceuticals, Inc.	68788-7573	68788-7573-4	473 mL in 1 BOTTLE (68788-7573-4)
ALBUTEROL SULFATE	albuterol sulfate	SYRUP;ORAL	212197	ANDA	QUAGEN PHARMACEUTICALS LLC	70752-102	70752-102-12	473 mL in 1 BOTTLE (70752-102-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	EQ 2MG BASE/5ML
Approval Date:	Sep 6, 2019	TE:	AA	RLD:	No

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