FDA.reportPublic FDA data

Application 205625

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARNUITY ELLIPTAFLUTICASONE FUROATEPOWDER;INHALATION0.1MG/INHYesYes
002ARNUITY ELLIPTAFLUTICASONE FUROATEPOWDER;INHALATION0.2MG/INHYesYes
003ARNUITY ELLIPTAFLUTICASONE FUROATEPOWDER;INHALATION0.05MG/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0874Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0874Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0874Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0874Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0874Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0876Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0876Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0876Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0876Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0876Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0888Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0888Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0888Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0888Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0888Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75863SUPPL 2023-10-19
75845SUPPL 2023-10-19
73656SUPPL 2023-03-02
73652SUPPL 2023-03-02
57541SUPPL2019-02-13
57128SUPPL2019-01-08
54267SUPPL2018-05-21
54260SUPPL2018-05-21
44927ORIG2015-10-07
43496ORIG2015-10-07
40486SUPPL2015-03-24
10479SUPPL2015-03-24
19668ORIG2014-08-22
10478ORIG2014-08-21
51112ORIG1900-01-01
51111ORIG1900-01-01
51110ORIG1900-01-01