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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 nine 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-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluticasone furoate profile page.

Summary for NDA: 205625

Tradename:
ARNUITY ELLIPTA
Applicant:
Glaxosmithkline
Ingredient:
fluticasone furoate
Patents:9
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 205625

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.1MG/INH
Approval Date:Aug 20, 2014TE:RLD:Yes
Patent:5,873,360Patent Expiration:Feb 23, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:7,629,335Patent Expiration:Aug 3, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:8,113,199Patent Expiration:Oct 23, 2027Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 205625

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-002Aug 20, 20145,873,360► subscribe
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-001Aug 20, 20145,873,360► subscribe
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