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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 206224

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NDA 206224 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, 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-four NDAs. It is available from forty-one 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 206224

Tradename:	ALBUTEROL SULFATE
Applicant:	Luoxin Aurovitas
Ingredient:	albuterol sulfate
Patents:	0

Pharmacology for NDA: 206224

Mechanism of Action	Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 206224

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALBUTEROL SULFATE	albuterol sulfate	SOLUTION;INHALATION	206224	ANDA	Aurobindo Pharma Limited	65862-858	65862-858-03	30 POUCH in 1 CARTON (65862-858-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
ALBUTEROL SULFATE	albuterol sulfate	SOLUTION;INHALATION	206224	ANDA	Aurobindo Pharma Limited	65862-858	65862-858-25	5 POUCH in 1 CARTON (65862-858-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	EQ 0.083% BASE
Approval Date:	Oct 17, 2017	TE:	AN	RLD:	No

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