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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 021457

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NDA 021457 describes PROAIR HFA, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from four suppliers. Additional details are available on the PROAIR HFA profile page.

The generic ingredient in PROAIR HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

Summary for 021457

Tradename:	PROAIR HFA
Applicant:	Teva Branded Pharm
Ingredient:	albuterol sulfate
Patents:	0

Pharmacology for NDA: 021457

Mechanism of Action	Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 021457

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-3174	0093-3174-31	1 INHALER in 1 CARTON (0093-3174-31) / 200 AEROSOL, METERED in 1 INHALER
PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457	NDA	NuCare Pharmaceuticals,Inc.	68071-4940	68071-4940-2	200 AEROSOL, METERED in 1 BOX (68071-4940-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	EQ 0.09MG BASE/INH
Approval Date:	Oct 29, 2004	TE:	AB2	RLD:	Yes

Expired US Patents for NDA 021457

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	7,566,445	⤷ Get Started Free
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	5,605,674	⤷ Get Started Free
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	8,834,849	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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