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Last Updated: November 18, 2019

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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 ten suppliers. There are seven 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-five 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:7
Formulation / Manufacturing:see details
Pharmacology for NDA: 021457
Mechanism of ActionAdrenergic 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:RXDosage:AEROSOL, METERED;INHALATIONStrengthEQ 0.09MG BASE/INH
Approval Date:Oct 29, 2004TE:BXRLD:Yes
Patent:  Start TrialPatent Expiration:May 18, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:May 18, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:May 18, 2031Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021457

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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