FDA.reportPublic FDA data

Application 021254

Type
NDA
Sponsor
GLAXO GRP LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADVAIR HFAFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEAEROSOL, METERED;INHALATION0.045MG/INH;EQ 0.021MG BASE/INHYesYes
002ADVAIR HFAFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEAEROSOL, METERED;INHALATION0.115MG/INH;EQ 0.021MG BASE/INHYesYes
003ADVAIR HFAFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEAEROSOL, METERED;INHALATION0.23MG/INH;EQ 0.021MG BASE/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0715ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0715ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0715ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0715ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0715ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0715ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0716ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0716ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0716ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0716ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0716ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0716ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0717ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0717ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0717ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0717ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0717ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0717ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68420SUPPL2021-08-19
68408SUPPL2021-08-19
57518SUPPL2019-02-13
57131SUPPL2019-01-08
50875SUPPL2017-12-27
50841SUPPL2017-12-22
47492SUPPL2017-03-08
47457SUPPL2017-03-03
36479SUPPL2014-12-20
4798SUPPL2014-12-12
36480SUPPL2014-12-11
4797SUPPL2014-11-14
27227SUPPL2012-12-21
14761SUPPL2012-12-21
4796SUPPL2012-08-13
27231SUPPL2011-07-05
36478SUPPL2011-05-16
27230SUPPL2011-05-12
27228SUPPL2011-01-07
27229SUPPL2010-06-29
14762SUPPL2010-06-28
4795SUPPL2009-10-26
36477SUPPL2009-09-21
4794SUPPL2008-08-05
21551ORIG2008-05-06
36476SUPPL2008-03-24
4793SUPPL2008-03-21
23639ORIG2006-06-19
36475ORIG2006-06-14
4792ORIG2006-06-14
51121SUPPL1900-01-01
51120SUPPL1900-01-01
51119SUPPL1900-01-01