Last Updated: September 24, 2026

Details for New Drug Application (NDA): 219409

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NDA 219409 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 Pharms Nc, 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 two 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 219409

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

Pharmacology for NDA: 219409

Mechanism of Action	Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 219409

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALBUTEROL SULFATE	albuterol sulfate	AEROSOL, METERED;INHALATION	219409	ANDA	Cipla USA Inc.	69097-021	69097-021-60	1 INHALER in 1 CARTON (69097-021-60) / 200 AEROSOL, METERED 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:	Apr 22, 2026	TE:	AB3	RLD:	No
Regulatory Exclusivity Expiration:	Dec 19, 2026
Regulatory Exclusivity Use:	COMPETITIVE GENERIC THERAPY

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