FDA.reportPublic FDA data

Application 022565

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADVIL CONGESTION RELIEFIBUPROFEN; PHENYLEPHRINE HYDROCHLORIDETABLET;ORAL200MG;10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0199ADVIL SINUS CONGESTION AND PAINibuprofen, phenylephrine hydrochlorideWyeth Consumer Healthcare LLCNDACurrent
0573-0199ADVIL SINUS CONGESTION AND PAINibuprofen, phenylephrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0199ADVIL SINUS CONGESTION AND PAINibuprofen, phenylephrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0199ADVIL SINUS CONGESTION AND PAINibuprofen, phenylephrine hydrochlorideWyeth Consumer Healthcare LLCNDACurrent
0573-0199ADVIL SINUS CONGESTION AND PAINibuprofen, phenylephrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
52904-782Advil Sinus Congestion and Painibuprofen, phenylephrine hydrochlorideSelect CorporationNDACurrent
67751-150Advil Sinus Congestion and Pain ReliefIBUPROFEN, PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.NDACurrent
67751-150Advil Sinus Congestion and Pain ReliefIBUPROFEN, PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69402SUPPL2021-11-23
69382SUPPL2021-11-23
64158SUPPL2020-07-31
64157SUPPL2020-07-31
59302SUPPL2019-07-10
59301SUPPL2019-07-10
48054SUPPL2017-04-18
48047SUPPL2017-04-17
17712SUPPL2015-04-14
29863SUPPL2015-04-02
44778ORIG2010-09-23
22058ORIG2010-09-23
29862ORIG2010-06-03