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Last Updated: March 18, 2024

Details for New Drug Application (NDA): 021077


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NDA 021077 describes ADVAIR DISKUS 500/50, which is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from five suppliers. Additional details are available on the ADVAIR DISKUS 500/50 profile page.

The generic ingredient in ADVAIR DISKUS 500/50 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 021077
Pharmacology for NDA: 021077
Suppliers and Packaging for NDA: 021077
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADVAIR DISKUS 100/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077 NDA GlaxoSmithKline LLC 0173-0695 0173-0695-00 1 INHALER in 1 CARTON (0173-0695-00) / 60 POWDER in 1 INHALER
ADVAIR DISKUS 100/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077 NDA GlaxoSmithKline LLC 0173-0695 0173-0695-04 1 INHALER in 1 CARTON (0173-0695-04) / 14 POWDER in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.1MG/INH;EQ 0.05MG BASE/INH
Approval Date:Aug 24, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.25MG/INH;EQ 0.05MG BASE/INH
Approval Date:Aug 24, 2000TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.5MG/INH;EQ 0.05MG BASE/INH
Approval Date:Aug 24, 2000TE:ABRLD:Yes

Expired US Patents for NDA 021077

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