FDA.reportPublic FDA data

Application 209482

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRELEGY ELLIPTAFLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATEPOWDER;INHALATION0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHYesYes
002TRELEGY ELLIPTAFLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATEPOWDER;INHALATION0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0887Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0887Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0887Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0887Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0887Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0887Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0887Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0893Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0893Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0893Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0893Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74433SUPPL 2023-06-05
74426SUPPL 2023-06-05
72793SUPPL2022-12-05
72787SUPPL2022-12-05
71060SUPPL2022-05-12
71057SUPPL2022-05-12
64550SUPPL2020-09-10
64549SUPPL2020-09-10
64547SUPPL2020-09-10
64546SUPPL2020-09-10
58757SUPPL2019-05-16
58749SUPPL2019-05-16
57543SUPPL2019-02-13
57140SUPPL2019-01-08
57127SUPPL2019-01-08
53814SUPPL2018-04-24
53803SUPPL2018-04-24
52674ORIG2018-02-20
49847ORIG2017-09-22
49812ORIG2017-09-20
49811ORIG2017-09-20