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 nine suppliers. There are eight patents protecting this drug. 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 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:	8
Formulation / Manufacturing:	see details

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	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	A-S Medication Solutions	50090-1329	50090-1329-0	1 INHALER in 1 CARTON (50090-1329-0) > 200 AEROSOL, METERED in 1 INHALER

Paragraph IV (Patent) Challenges for 021457

Tradename	Dosage	Ingredient	NDA	Submissiondate
PROAIR HFA	AEROSOL, METERED;INHALATION	albuterol sulfate	021457	2012-05-18

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
Patent:	Start Trial	Patent Expiration:	May 18, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	Start Trial	Patent Expiration:	May 18, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	Start Trial	Patent Expiration:	May 18, 2031	Product Flag?	Y	Substance Flag?		Delist Request?

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	Start Trial	Start Trial
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	Start Trial	Start Trial
Teva Branded Pharm	PROAIR HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	021457-001	Oct 29, 2004	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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