Details for New Drug Application (NDA): 205625

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NDA 205625 describes ARNUITY ELLIPTA, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the ARNUITY ELLIPTA profile page.

The generic ingredient in ARNUITY ELLIPTA is fluticasone furoate. There are twenty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fluticasone furoate profile page.

Summary for 205625

Tradename:	ARNUITY ELLIPTA
Applicant:	Glaxosmithkline
Ingredient:	fluticasone furoate
Patents:	8
Formulation / Manufacturing:	see details

Pharmacology for NDA: 205625

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 205625

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625	NDA	GlaxoSmithKline LLC	0173-0874	0173-0874-10	1 INHALER in 1 CARTON (0173-0874-10) > 30 POWDER in 1 INHALER
ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625	NDA	GlaxoSmithKline LLC	0173-0874	0173-0874-14	1 INHALER in 1 CARTON (0173-0874-14) > 14 POWDER in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INHALATION			Strength	0.1MG/INH
Approval Date:	Aug 20, 2014	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	May 17, 2021
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Patent:	➤ Sign Up	Patent Expiration:	Aug 3, 2021	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	INDICATED FOR THE ONCE-DAILY MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN PATIENTS AGED 12 YEARS OF AGE AND OLDER
Patent:	➤ Sign Up	Patent Expiration:	Aug 3, 2021	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 205625

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014	➤ Sign Up	➤ Sign Up
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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