FDA.reportPublic FDA data

Application 205382

Type
NDA
Sponsor
GLAXO GRP ENGLAND

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INCRUSE ELLIPTAUMECLIDINIUM BROMIDEPOWDER;INHALATIONEQ 62.5MCG BASE/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0873Incruse ElliptaumeclidiniumGlaxoSmithKline LLCNDACurrent
0173-0873Incruse ElliptaumeclidiniumGlaxoSmithKline LLCNDACurrent
0173-0873Incruse ElliptaumeclidiniumGlaxoSmithKline LLCNDACurrent
0173-0873Incruse ElliptaumeclidiniumGlaxoSmithKline LLCNDACurrent
0173-0873Incruse ElliptaumeclidiniumGlaxoSmithKline LLCNDACurrent
0173-0873Incruse ElliptaumeclidiniumGlaxoSmithKline LLCNDACurrent
0173-0873Incruse ElliptaumeclidiniumGlaxoSmithKline LLCNDACurrent
0173-0873Incruse ElliptaumeclidiniumGlaxoSmithKline LLCNDACurrent
0173-0873Incruse ElliptaumeclidiniumGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76823SUPPL 2023-12-14
76796SUPPL 2023-12-14
58997SUPPL2019-06-07
58994SUPPL2019-06-07
50167SUPPL2017-10-24
50131SUPPL2017-10-23
48751SUPPL2017-06-16
48714SUPPL2017-06-14
32664SUPPL2016-02-26
19638SUPPL2016-02-26
44917ORIG2015-08-11
22984ORIG2015-08-11
19637ORIG2014-05-02
10440ORIG2014-05-01