umeclidinium Dry Powder Inhaler

Brand(s)
Incruse
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2014-06-25)
Oldest Current Product
2014-04-30
License(s)
NDA
RxNORM
DRY POWDER INHALER\UMECLIDINIUM
FDAOB
INHALATION\POWDER\UMECLIDINIUM BROMIDE\rdfq
SPL Active
ORAL\AEROSOL, POWDER\UMECLIDINIUM BROMIDE
SPL Moiety
ORAL\AEROSOL, POWDER\UMECLIDINIUM

product(s) by strength(s)

umeclidinium 0.0625 mg/actuat dry powder inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730873IncruseNDAGlaxosmithkline Llc2014-04-30UMECLIDINIUM BROMIDEORALAEROSOL, POWDERNDA205382dbb64747-1505-49d7-9a33-99dd402e96d3

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA205382INCRUSE ELLIPTA GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE2014-04-30p8113199, SUBSTANCE
p8746242, SUBSTANCE
p8183257, INDICATED FOR THE LONG-TERM
p8309572, INDICATED FOR THE LONG-TERM
p8201556, SUBSTANCE
p5873360, SUBSTANCE
p7488827, SUBSTANCE
p7498440, SUBSTANCE
p8161968, SUBSTANCE
p8534281, SUBSTANCE
NDA205382_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA205382_001RXUMECLIDINIUM BROMIDE (EQ 62.5MCG BASE/INH)POWDERTrue2014-04-30INCRUSE ELLIPTA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5873360 (view patent)2016-02-23NDA205382, NDA020692, NDA020833, NDA021077, NDA203975, NDA204275, NDA205625fluticasone / salmeterol Dry Powder Inhaler
fluticasone / vilanterol Dry Powder Inhaler
fluticasone Dry Powder Inhaler
umeclidinium / vilanterol Dry Powder Inhaler
salmeterol Dry Powder Inhaler
2p7488827 (view patent)2025-04-27NDA205382, NDA203975umeclidinium / vilanterol Dry Powder Inhaler
3p7498440 (view patent)2025-04-27NDA205382, NDA203975umeclidinium / vilanterol Dry Powder Inhaler
4p8113199 (view patent)2027-10-23NDA205382, NDA203975, NDA204275, NDA205625fluticasone / vilanterol Dry Powder Inhaler
fluticasone Dry Powder Inhaler
umeclidinium / vilanterol Dry Powder Inhaler
5p8161968 (view patent)2028-02-05NDA205382, NDA203975, NDA204275, NDA205625fluticasone / vilanterol Dry Powder Inhaler
fluticasone Dry Powder Inhaler
umeclidinium / vilanterol Dry Powder Inhaler
6p8183257 (view patent)2025-07-27NDA205382, NDA203975umeclidinium / vilanterol Dry Powder Inhaler
7p8201556 (view patent)2029-02-05NDA205382, NDA205625fluticasone Dry Powder Inhaler
8p8309572 (view patent)2025-04-27NDA205382, NDA203975umeclidinium / vilanterol Dry Powder Inhaler
9p8534281 (view patent)2029-08-10NDA205382, NDA203975, NDA204275, NDA205625fluticasone / vilanterol Dry Powder Inhaler
fluticasone Dry Powder Inhaler
umeclidinium / vilanterol Dry Powder Inhaler
10p8746242 (view patent)2030-10-11NDA205382, NDA203975, NDA204275, NDA205625fluticasone / vilanterol Dry Powder Inhaler
fluticasone Dry Powder Inhaler
umeclidinium / vilanterol Dry Powder Inhaler

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1dbb64747-1505-49d7-9a33-99dd402e96d3 (view SPL)These highlights do not include all the information needed to use INCRUSE ELLIPTA safely and effectively. See full prescribing information for INCRUSE ELLIPTA.INCRUSE ELLIPTA (umeclidinium inhalation powder)FOR ORAL INHALATION USEInitial U.S. Approval: 2013prescriptionHuman PrescriptionGlaxosmithkline Llc2014-06-255001730873

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