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

Summary for NDA: 205625

fluticasone furoate
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
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
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: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?
Patent:8,161,968Patent Expiration:Feb 5, 2028Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 205625

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
fluticasone furoate
POWDER;INHALATION205625-002Aug 20, 20145,873,360► subscribe
fluticasone furoate
POWDER;INHALATION205625-001Aug 20, 20145,873,360► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.