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Last Updated: November 21, 2024

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. There are nine 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:9
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 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:RXDosage:AEROSOL, METERED;INHALATIONStrengthEQ 0.09MG BASE/INH
Approval Date:Oct 29, 2004TE:AB2RLD:Yes
Patent:⤷  Sign UpPatent Expiration:May 18, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:May 18, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent 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 ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm PROAIR HFA albuterol sulfate AEROSOL, METERED;INHALATION 021457-001 Oct 29, 2004 ⤷  Sign Up ⤷  Sign Up
>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.