FDA.reportPublic FDA data

Application 203975

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANORO ELLIPTAUMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATEPOWDER;INHALATIONEQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0869Anoro Elliptaumeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0869Anoro Elliptaumeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0869Anoro Elliptaumeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0869Anoro Elliptaumeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0869Anoro Elliptaumeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0869Anoro Elliptaumeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0869Anoro Elliptaumeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0869Anoro Elliptaumeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0869Anoro Elliptaumeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0869Anoro Elliptaumeclidinium bromide and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74431SUPPL 2023-06-05
74430SUPPL 2023-06-05
72447SUPPL2022-10-21
72443SUPPL2022-10-21
59172SUPPL2019-06-26
59169SUPPL2019-06-25
58947SUPPL2019-06-04
58887SUPPL2019-05-30
50118SUPPL2017-10-19
50099SUPPL2017-10-19
47680SUPPL2017-03-24
47657SUPPL2017-03-23
47656SUPPL2017-03-23
40333SUPPL2016-02-26
10262SUPPL2016-02-26
43449ORIG2014-01-06
24454ORIG2014-01-06
32484ORIG2013-12-20
40332ORIG2013-12-19