FDA.reportPublic FDA data

Application 019771

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADVIL COLD AND SINUSIBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDETABLET;ORAL200MG;30MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0180ADVIL COLD AND SINUSibuprofen and pseudoephedrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0180ADVIL COLD AND SINUSibuprofen and pseudoephedrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0180ADVIL COLD AND SINUSIBUPROFEN and PSEUDOEPHEDRINE HYDROCHLORIDEPfizer Consumer HealthcareNDACurrent
0573-0180ADVIL COLD AND SINUSibuprofen and pseudoephedrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69400SUPPL2021-11-23
69377SUPPL2021-11-23
47701SUPPL2017-03-24
47665SUPPL2017-03-24
19185SUPPL2010-09-07
1593SUPPL2009-05-26
19184SUPPL2008-06-23
19183SUPPL2006-04-20
1592SUPPL2006-03-01
1591SUPPL2003-10-22
33933SUPPL2003-06-10