FDA.reportPublic FDA data

Application 204275

Type
NDA
Sponsor
GLAXO GRP LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BREO ELLIPTAFLUTICASONE FUROATE; VILANTEROL TRIFENATATEPOWDER;INHALATION0.1MG/INH;EQ 0.025MG BASE/INHYesYes
002BREO ELLIPTAFLUTICASONE FUROATE; VILANTEROL TRIFENATATEPOWDER;INHALATION0.2MG/INH;EQ 0.025MG BASE/INHYesYes
003BREO ELLIPTAFLUTICASONE FUROATE; VILANTEROL TRIFENATATEPOWDER;INHALATION0.05MG/INH;EQ 0.025MG BASE/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0859Breo Elliptafluticasone furoate and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0859Breo Elliptafluticasone furoate and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0859Breo Elliptafluticasone furoate and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0859Breo Elliptafluticasone furoate and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0859Breo Elliptafluticasone furoate and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0882Breo Elliptafluticasone furoate and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0882Breo Elliptafluticasone furoate and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0882Breo Elliptafluticasone furoate and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0882Breo Elliptafluticasone furoate and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
0173-0882Breo Elliptafluticasone furoate and vilanterol trifenatateGlaxoSmithKline LLCNDACurrent
50090-2404Breo Elliptafluticasone furoate and vilanterol trifenatateA-S Medication SolutionsNDACurrent
66993-135Fluticasone Furoate and Vilanterolfluticasone furoate and vilanterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-136Fluticasone Furoate and Vilanterolfluticasone furoate and vilanterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
70518-2028Breo Elliptafluticasone furoate and vilanterol trifenatateREMEDYREPACK INC.NDACurrent
70518-2028Breo Elliptafluticasone furoate and vilanterol trifenatateREMEDYREPACK INC.NDACurrent
70518-2028Breo Elliptafluticasone furoate and vilanterol trifenatateREMEDYREPACK INC.NDACurrent
70518-2028Breo Elliptafluticasone furoate and vilanterol trifenatateREMEDYREPACK INC.NDACurrent
70518-2028Breo Elliptafluticasone furoate and vilanterol trifenatateREMEDYREPACK INC.NDACurrent
70518-2028Breo Elliptafluticasone furoate and vilanterol trifenatateREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74250SUPPL 2023-05-15
74241SUPPL 2023-05-15
57538SUPPL2019-02-13
57129SUPPL2019-01-08
50879SUPPL2017-12-27
50842SUPPL2017-12-22
48403SUPPL2017-05-17
48387SUPPL2017-05-17
45804SUPPL2016-11-04
45776SUPPL2016-11-02
40370SUPPL2016-02-18
32536SUPPL2016-02-18
40369SUPPL2015-09-23
32535SUPPL2015-09-16
40368SUPPL2015-05-04
32534SUPPL2015-05-04
19540SUPPL2015-03-05
10315SUPPL2015-03-03
22949ORIG2013-06-10
19539ORIG2013-05-14
32533ORIG2013-05-13