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Last Updated: April 1, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021254


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NDA 021254 describes ADVAIR HFA, which is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ADVAIR HFA profile page.

The generic ingredient in ADVAIR HFA is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
Summary for 021254
Tradename:ADVAIR HFA
Applicant:Glaxo Grp Ltd
Ingredient:fluticasone propionate; salmeterol xinafoate
Patents:4
Pharmacology for NDA: 021254
Suppliers and Packaging for NDA: 021254
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADVAIR HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254 NDA GlaxoSmithKline LLC 0173-0715 0173-0715-20 1 INHALER in 1 CARTON (0173-0715-20) > 120 AEROSOL, METERED in 1 INHALER
ADVAIR HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254 NDA GlaxoSmithKline LLC 0173-0715 0173-0715-22 1 INHALER in 1 CARTON (0173-0715-22) > 60 AEROSOL, METERED in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.045MG/INH;EQ 0.021MG BASE/INH
Approval Date:Jun 8, 2006TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 24, 2019Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Aug 26, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Dec 19, 2023Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021254

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd ADVAIR HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-003 Jun 8, 2006   Start Trial   Start Trial
Glaxo Grp Ltd ADVAIR HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-002 Jun 8, 2006   Start Trial   Start Trial
Glaxo Grp Ltd ADVAIR HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-001 Jun 8, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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