Details for New Drug Application (NDA): 021433

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NDA 021433 describes FLOVENT HFA, which is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from five suppliers. There is one patent protecting this drug. Additional details are available on the FLOVENT HFA profile page.

The generic ingredient in FLOVENT HFA is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-five suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

Summary for 021433

Tradename:	FLOVENT HFA
Applicant:	Glaxo Grp Ltd
Ingredient:	fluticasone propionate
Patents:	1

Pharmacology for NDA: 021433

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 021433

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433	NDA	GlaxoSmithKline LLC	0173-0718	0173-0718-20	1 INHALER in 1 CARTON (0173-0718-20) / 120 AEROSOL, METERED in 1 INHALER
FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433	NDA	GlaxoSmithKline LLC	0173-0719	0173-0719-20	1 INHALER in 1 CARTON (0173-0719-20) / 120 AEROSOL, METERED in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	0.22MG/INH
Approval Date:	May 14, 2004	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Aug 26, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	0.11MG/INH
Approval Date:	May 14, 2004	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Aug 26, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	0.044MG/INH
Approval Date:	May 14, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021433

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004	⤷ Sign Up	⤷ Sign Up
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-002	May 14, 2004	⤷ Sign Up	⤷ Sign Up
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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