FDA.reportPublic FDA data

Application 021036

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RELENZAZANAMIVIRPOWDER;INHALATION5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0681RELENZAzanamivirGlaxoSmithKline LLCNDACurrent
0173-0681RELENZAzanamivirGlaxoSmithKline LLCNDACurrent
0173-0681RELENZAzanamivirGlaxoSmithKline LLCNDACurrent
0173-0681RELENZAzanamivirGlaxoSmithKline LLCNDACurrent
0173-0681RELENZAzanamivirGlaxoSmithKline LLCNDACurrent
0173-0681RELENZAzanamivirGlaxoSmithKline LLCNDACurrent
0173-0681RELENZAzanamivirGlaxoSmithKline LLCNDACurrent
68258-3030RELENZAzanamivirDispensing Solutions Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75942SUPPL 2023-10-25
75924SUPPL 2023-10-25
69045SUPPL2021-10-21
69031SUPPL2021-10-20
54698SUPPL2018-06-27
54691SUPPL2018-06-27
21364SUPPL2014-01-16
14218SUPPL2011-12-23
26554SUPPL2011-12-22
4122SUPPL2010-12-15
35949SUPPL2010-12-10
4121SUPPL2010-05-07
26553SUPPL2010-03-29
35948SUPPL2010-03-26
26552SUPPL2009-10-16
26551SUPPL2009-10-16
26548SUPPL2009-10-16
4118SUPPL2009-10-16
4116SUPPL2009-10-16
35947SUPPL2008-10-09
4120SUPPL2008-10-07
35946SUPPL2008-02-25
4119SUPPL2008-02-25
26550SUPPL2007-09-11
14217SUPPL2007-09-11
4117SUPPL2007-03-15
26549SUPPL2006-04-05
14216SUPPL2006-04-03
26546SUPPL2004-06-15
21363SUPPL2004-04-12
35944SUPPL2003-10-07
35945SUPPL2003-08-15
26547SUPPL2003-08-15
14215SUPPL2001-04-27
35943SUPPL2000-04-26
26545SUPPL2000-04-26
21362ORIG1999-07-26
14214ORIG1999-07-26
4115ORIG1999-07-26