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

Tradename:	ADVAIR DISKUS 500/50
Applicant:	Glaxo Grp Ltd
Ingredient:	fluticasone propionate; salmeterol xinafoate
Patents:	0

Pharmacology for NDA: 021077

Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

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:	RX	Dosage:	POWDER;INHALATION			Strength	0.1MG/INH;EQ 0.05MG BASE/INH
Approval Date:	Aug 24, 2000	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INHALATION			Strength	0.25MG/INH;EQ 0.05MG BASE/INH
Approval Date:	Aug 24, 2000	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INHALATION			Strength	0.5MG/INH;EQ 0.05MG BASE/INH
Approval Date:	Aug 24, 2000	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021077

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ADVAIR DISKUS 500/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-003	Aug 24, 2000	6,792,945*PED	⤷ Subscribe
Glaxo Grp Ltd	ADVAIR DISKUS 250/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-002	Aug 24, 2000	5,860,419*PED	⤷ Subscribe
Glaxo Grp Ltd	ADVAIR DISKUS 500/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-003	Aug 24, 2000	6,536,427*PED	⤷ Subscribe
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