fluticasone / salmeterol Dry Powder Inhaler

Brand(s)
Advair
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2014-07-23)
Oldest Current Product
2001-02-05
License(s)
NDA
RxNORM
DRY POWDER INHALER\FLUTICASONE:SALMETEROL
FDAOB
INHALATION\POWDER\FLUTICASONE PROPIONATE: SALMETEROL XINAFOATE\rdfq
SPL Active
ORAL\POWDER\FLUTICASONE PROPIONATE: SALMETEROL XINAFOATE
RESPIRATORY (INHALATION)\POWDER\FLUTICASONE PROPIONATE: SALMETEROL XINAFOATE
SPL Moiety
ORAL\POWDER\FLUTICASONE: SALMETEROL
RESPIRATORY (INHALATION)\POWDER\FLUTICASONE: SALMETEROL

product(s) by strength(s)

fluticasone propionate 0.1 mg/actuat / salmeterol 0.05 mg/actuat dry powder inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730695AdvairNDAGlaxosmithkline Llc2001-02-28FLUTICASONE PROPIONATE, SALMETEROL XINAFOATERESPIRATORY (INHALATION)POWDERNDA0210774eeb5f6a-593f-4a9e-9692-adefa2caf8fc

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950361AdvairNDARebel Distributors Corp2001-02-28FLUTICASONE PROPIONATE, SALMETEROL XINAFOATERESPIRATORY (INHALATION)POWDER001730695NDA0210770bfe9d76-1b0e-47a4-831d-097168d66577
2332610873AdvairNDAAidarex Pharmaceuticals Llc2001-02-28FLUTICASONE PROPIONATE, SALMETEROL XINAFOATERESPIRATORY (INHALATION)POWDER001730695NDA021077f53cb2d5-3267-401e-9393-dff8357830dd
3499990984AdvairNDALake Erie Medical Dba Quality Care Products Llc2012-02-17FLUTICASONE PROPIONATE, SALMETEROL XINAFOATERESPIRATORY (INHALATION)POWDER001730695NDA0210776f7253f0-fbea-434f-b28f-e78f201b032c
4548684518AdvairNDAPhysicians Total Care, Inc.2001-06-21FLUTICASONE PROPIONATE, SALMETEROL XINAFOATEORALPOWDER001730695NDA021077b20c1d84-5c49-47de-bd2e-f987ff67faef

fluticasone propionate 0.25 mg/actuat / salmeterol 0.05 mg/actuat dry powder inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730696AdvairNDAGlaxosmithkline Llc2001-02-05FLUTICASONE PROPIONATE, SALMETEROL XINAFOATERESPIRATORY (INHALATION)POWDERNDA0210774eeb5f6a-593f-4a9e-9692-adefa2caf8fc

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950196AdvairNDARebel Distributors Corp2001-02-05FLUTICASONE PROPIONATE, SALMETEROL XINAFOATEORALPOWDER001730696NDA0210779e0bdea8-df9b-4873-b24b-919cebff5edd
2332610874AdvairNDAAidarex Pharmaceuticals Llc2001-02-05FLUTICASONE PROPIONATE, SALMETEROL XINAFOATERESPIRATORY (INHALATION)POWDER001730696NDA021077f53cb2d5-3267-401e-9393-dff8357830dd
3499990819AdvairNDALake Erie Medical Dba Quality Care Products Llc2012-02-17FLUTICASONE PROPIONATE, SALMETEROL XINAFOATERESPIRATORY (INHALATION)POWDER001730696NDA0210776f7253f0-fbea-434f-b28f-e78f201b032c
4521250856AdvairNDARemedyrepack Inc.2014-02-28FLUTICASONE PROPIONATE, SALMETEROL XINAFOATERESPIRATORY (INHALATION)POWDER001730696NDA02107759e4e3e6-df7e-4d89-a540-1dccf14d172e
5548684517AdvairNDAPhysicians Total Care, Inc.2001-06-21FLUTICASONE PROPIONATE, SALMETEROL XINAFOATEORALPOWDER001730696NDA021077b20c1d84-5c49-47de-bd2e-f987ff67faef
6682583031AdvairNDADispensing Solutions, Inc.2001-02-05FLUTICASONE PROPIONATE, SALMETEROL XINAFOATEORALPOWDER00173069600NDA021077de811b6d-ca0e-4921-a127-b10101ee0035

fluticasone propionate 0.5 mg/actuat / salmeterol 0.05 mg/actuat dry powder inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730697AdvairNDAGlaxosmithkline Llc2001-03-05FLUTICASONE PROPIONATE, SALMETEROL XINAFOATERESPIRATORY (INHALATION)POWDERNDA0210774eeb5f6a-593f-4a9e-9692-adefa2caf8fc

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950197AdvairNDARebel Distributors Corp2001-03-05FLUTICASONE PROPIONATE, SALMETEROL XINAFOATEORALPOWDER001730697NDA0210779e0bdea8-df9b-4873-b24b-919cebff5edd
2493490738AdvairNDARemedyrepack Inc.2013-06-10FLUTICASONE PROPIONATE, SALMETEROL XINAFOATERESPIRATORY (INHALATION)POWDER001730697NDA02107758ed5fef-3da7-41d2-850d-55f72efcdb78, a143aafc-c58d-4c19-bfb5-bc5cbd55029a
3499990985AdvairNDALake Erie Medical Dba Quality Care Products Llc2012-02-17FLUTICASONE PROPIONATE, SALMETEROL XINAFOATERESPIRATORY (INHALATION)POWDER001730697NDA0210776f7253f0-fbea-434f-b28f-e78f201b032c
4548684516AdvairNDAPhysicians Total Care, Inc.2001-06-21FLUTICASONE PROPIONATE, SALMETEROL XINAFOATEORALPOWDER001730697NDA021077b20c1d84-5c49-47de-bd2e-f987ff67faef

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021077ADVAIR DISKUS 100/50GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE2000-08-24p5873360, SUBSTANCENDA021077_001, NDA021077_002, NDA021077_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA021077_001RXSALMETEROL XINAFOATE (EQ 0.05MG BASE/INH), FLUTICASONE PROPIONATE (0.1MG/INH)POWDERTrue2000-08-24ADVAIR DISKUS 100/50
2NDA021077_002RXFLUTICASONE PROPIONATE (0.25MG/INH), SALMETEROL XINAFOATE (EQ 0.05MG BASE/INH)POWDERTrue2000-08-24ADVAIR DISKUS 100/50
3NDA021077_003RXFLUTICASONE PROPIONATE (0.5MG/INH), SALMETEROL XINAFOATE (EQ 0.05MG BASE/INH)POWDERTrue2000-08-24ADVAIR DISKUS 100/50

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5873360 (view patent)2016-02-23NDA021077, NDA020692, NDA020833, NDA203975, NDA204275, NDA205382, NDA205625fluticasone / vilanterol Dry Powder Inhaler
umeclidinium Dry Powder Inhaler
fluticasone Dry Powder Inhaler
umeclidinium / vilanterol Dry Powder Inhaler
salmeterol Dry Powder Inhaler

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10bfe9d76-1b0e-47a4-831d-097168d66577 (view SPL)These highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS.ADVAIR DISKUS 100/50(fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 250/50(fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 500/50(fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder)FOR ORAL INHALATIONInitial U.S. Approval: 2000prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-07-201216950361
24eeb5f6a-593f-4a9e-9692-adefa2caf8fc (view SPL)These highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS.ADVAIR DISKUS 100/50(fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 250/50(fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 500/50(fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder)FOR ORAL INHALATION USEInitial U.S. Approval: 2000prescriptionHuman PrescriptionGlaxosmithkline Llc2014-07-2315001730695, 001730696, 001730697
358ed5fef-3da7-41d2-850d-55f72efcdb78 (view SPL)These highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS.ADVAIR DISKUS 100/50(fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 250/50(fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 500/50(fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder)FOR ORAL INHALATIONInitial U.S. Approval: 2000prescriptionHuman PrescriptionRemedyrepack Inc.2013-06-101493490738
459e4e3e6-df7e-4d89-a540-1dccf14d172e (view SPL)These highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS.ADVAIR DISKUS 100/50(fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 250/50(fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 500/50(fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder)FOR ORAL INHALATIONInitial U.S. Approval: 2000prescriptionHuman PrescriptionRemedyrepack Inc.2014-02-281521250856
56f7253f0-fbea-434f-b28f-e78f201b032c (view SPL)These highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS.ADVAIR DISKUS 100/50(fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 250/50(fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 500/50(fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder)FOR ORAL INHALATIONInitial U.S. Approval: 2000prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-03-053614499990819, 499990984, 499990985
69e0bdea8-df9b-4873-b24b-919cebff5edd (view SPL)These highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS.ADVAIR DISKUS 100/50(fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 250/50(fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 500/50(fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder)FOR ORAL INHALATIONInitial U.S. Approval: 2000prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-011216950196, 216950197
7a143aafc-c58d-4c19-bfb5-bc5cbd55029a (view SPL)These highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS.ADVAIR DISKUS 100/50(fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 250/50(fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 500/50(fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder)FOR ORAL INHALATIONInitial U.S. Approval: 2000prescriptionHuman PrescriptionRemedyrepack Inc.2013-06-101493490738
8b20c1d84-5c49-47de-bd2e-f987ff67faef (view SPL)These highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS.ADVAIR DISKUS 100/50(fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 250/50(fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 500/50(fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder)FOR ORAL INHALATIONInitial U.S. Approval: 2000prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-06-211548684516, 548684517, 548684518
9de811b6d-ca0e-4921-a127-b10101ee0035 (view SPL)These highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS.ADVAIR DISKUS 100/50(fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 250/50(fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 500/50(fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder)FOR ORAL INHALATIONInitial U.S. Approval: 2000prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2010-03-021682583031
10f53cb2d5-3267-401e-9393-dff8357830dd (view SPL)These highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS.ADVAIR DISKUS 100/50(fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 250/50(fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 500/50(fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder)FOR ORAL INHALATIONInitial U.S. Approval: 2000prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2012-09-105332610873, 332610874

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