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Last Updated: December 3, 2024

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 three suppliers. 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. Twelve 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:0
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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.115MG/INH;EQ 0.021MG BASE/INH
Approval Date:Jun 8, 2006TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.23MG/INH;EQ 0.021MG BASE/INH
Approval Date:Jun 8, 2006TE:RLD:Yes

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

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