fluticasone Dry Powder Inhaler

Brand(s)
Arnuity, Flovent
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2014-11-10)
Oldest Current Product
2007-05-08
License(s)
NDA
RxNORM
DRY POWDER INHALER\FLUTICASONE
FDAOB
INHALATION\POWDER\FLUTICASONE FUROATE\rdfq
INHALATION\POWDER\FLUTICASONE PROPIONATE\rdfq
SPL Active
RESPIRATORY (INHALATION)\POWDER, METERED\FLUTICASONE PROPIONATE
RESPIRATORY (INHALATION)\POWDER\FLUTICASONE FUROATE
SPL Moiety
RESPIRATORY (INHALATION)\POWDER, METERED\FLUTICASONE
RESPIRATORY (INHALATION)\POWDER\FLUTICASONE

product(s) by strength(s)

fluticasone propionate 0.05 mg/actuat dry powder inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730600FloventNDAGlaxosmithkline Llc2007-05-08FLUTICASONE PROPIONATERESPIRATORY (INHALATION)POWDER, METEREDNDA020833001f22f8-a83d-495f-9196-d0264ef4d76e

fluticasone propionate 0.1 mg/actuat dry powder inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730602FloventNDAGlaxosmithkline Llc2008-10-13FLUTICASONE PROPIONATERESPIRATORY (INHALATION)POWDER, METEREDNDA020833001f22f8-a83d-495f-9196-d0264ef4d76e

fluticasone propionate 0.25 mg/actuat dry powder inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730601FloventNDAGlaxosmithkline Llc2008-10-13FLUTICASONE PROPIONATERESPIRATORY (INHALATION)POWDER, METEREDNDA020833001f22f8-a83d-495f-9196-d0264ef4d76e

fluticasone furoate 0.1 mg/actuat dry powder inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730874ArnuityNDAGlaxosmithkline Llc2014-08-20FLUTICASONE FUROATERESPIRATORY (INHALATION)POWDERNDA20562550f193ee-1691-486d-9370-a664df63695c

fluticasone furoate 0.2 mg/actuat dry powder inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730876ArnuityNDAGlaxosmithkline Llc2014-08-20FLUTICASONE FUROATERESPIRATORY (INHALATION)POWDERNDA20562550f193ee-1691-486d-9370-a664df63695c

application(s)

#idtitledeprecatedapplicantapprovedpatentexclusivityapproved drug
1NDA020549FLOVENTTrueGLAXOSMITHKLINE1997-11-07NDA020549_001, NDA020549_002, NDA020549_003
2NDA020833FLOVENT DISKUS 100GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE2000-09-29p5873360, SUBSTANCENDA020833_001, NDA020833_002, NDA020833_003
3NDA205625ARNUITY ELLIPTAGLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND2014-08-20p8113199, SUBSTANCE
p7101866, INDICATED FOR THE ONCE-DAILY MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN PATIENTS AGED 12 YEARS OF AGE AND OLDER, SUBSTANCE
p7629335, SUBSTANCE
p8201556, SUBSTANCE
p5873360, SUBSTANCE
p8746242, SUBSTANCE
p8161968, SUBSTANCE
p8534281, SUBSTANCE
NEW PRODUCT [2017-08-20]NDA205625_001, NDA205625_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA020549_001discontinuedFLUTICASONE PROPIONATE (0.044MG/INH)POWDERFalse1997-11-07FLOVENT
2NDA020549_002discontinuedFLUTICASONE PROPIONATE (0.088MG/INH)POWDERFalse1997-11-07FLOVENT
3NDA020549_003discontinuedFLUTICASONE PROPIONATE (0.22MG/INH)POWDERFalse1997-11-07FLOVENT
4NDA020833_001RXFLUTICASONE PROPIONATE (0.05MG/INH)POWDERTrue2000-09-29FLOVENT DISKUS 100
5NDA020833_002RXFLUTICASONE PROPIONATE (0.1MG/INH)POWDERTrue2000-09-29FLOVENT DISKUS 100
6NDA020833_003RXFLUTICASONE PROPIONATE (0.25MG/INH)POWDERTrue2000-09-29FLOVENT DISKUS 100
7NDA205625_001RXFLUTICASONE FUROATE (0.1MG/INH)POWDERFalse2014-08-20ARNUITY ELLIPTA
8NDA205625_002RXFLUTICASONE FUROATE (0.2MG/INH)POWDERTrue2014-08-20ARNUITY ELLIPTA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5873360 (view patent)2016-02-23NDA020833, NDA205625, NDA020692, NDA021077, NDA203975, NDA204275, NDA205382fluticasone / salmeterol Dry Powder Inhaler
fluticasone / vilanterol Dry Powder Inhaler
umeclidinium Dry Powder Inhaler
umeclidinium / vilanterol Dry Powder Inhaler
salmeterol Dry Powder Inhaler
2p7101866 (view patent)2021-08-03NDA205625, NDA022051, NDA204275fluticasone Nasal Inhaler
fluticasone / vilanterol Dry Powder Inhaler
3p7629335 (view patent)2021-08-03NDA205625, NDA204275fluticasone / vilanterol Dry Powder Inhaler
4p8113199 (view patent)2027-10-23NDA205625, NDA203975, NDA204275, NDA205382fluticasone / vilanterol Dry Powder Inhaler
umeclidinium Dry Powder Inhaler
umeclidinium / vilanterol Dry Powder Inhaler
5p8161968 (view patent)2028-02-05NDA205625, NDA203975, NDA204275, NDA205382fluticasone / vilanterol Dry Powder Inhaler
umeclidinium Dry Powder Inhaler
umeclidinium / vilanterol Dry Powder Inhaler
6p8201556 (view patent)2029-02-05NDA205625, NDA205382umeclidinium Dry Powder Inhaler
7p8534281 (view patent)2029-08-10NDA205625, NDA203975, NDA204275, NDA205382fluticasone / vilanterol Dry Powder Inhaler
umeclidinium Dry Powder Inhaler
umeclidinium / vilanterol Dry Powder Inhaler
8p8746242 (view patent)2030-10-11NDA205625, NDA203975, NDA204275, NDA205382fluticasone / vilanterol Dry Powder Inhaler
umeclidinium Dry Powder Inhaler
umeclidinium / vilanterol Dry Powder Inhaler

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1001f22f8-a83d-495f-9196-d0264ef4d76e (view SPL)These highlights do not include all the information needed to use FLOVENT DISKUS safely and effectively. See full prescribing information for FLOVENT DISKUS.FLOVENT DISKUS 50mcg(fluticasone propionate inhalation powder, 50mcg)FLOVENT DISKUS 100mcg(fluticasone propionate inhalation powder, 100mcg)FLOVENT DISKUS 250mcg(fluticasone propionate inhalation powder, 250mcg)FOR ORAL INHALATION USEInitial U.S. Approval: 1994prescriptionHuman PrescriptionGlaxosmithkline Llc2014-05-0919001730600, 001730601, 001730602
250f193ee-1691-486d-9370-a664df63695c (view SPL)These highlights do not include all the information needed to use ARNUITY ELLIPTA safely and effectively. See full prescribing information for ARNUITY ELLIPTA.ARNUITY ELLIPTA (fluticasone furoate inhalation powder) 100 mcgARNUITY ELLIPTA (fluticasone furoate inhalation powder) 200mcgFOR ORAL INHALATIONInitial U.S. Approval: 2014prescriptionHuman PrescriptionGlaxosmithkline Llc2014-11-104001730874, 001730876

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII