FDA.reportPublic FDA data

Application 020589

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S ADVILIBUPROFENSUSPENSION;ORAL100MG/5MLNoNo
002CHILDREN'S ADVIL-FLAVOREDIBUPROFENSUSPENSION;ORAL100MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0170CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0170CHILDRENS ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0170CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0170CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0170CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0171CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0171CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0171CHILDRENS ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0171CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0171CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0174CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0174CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0174CHILDRENS ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0174CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0174CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0207CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0207CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0207CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0207CHILDRENS ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0207CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0232CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0232CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0232CHILDRENS ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0232CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0232CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0290CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0290CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0290CHILDRENS ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0290CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0290CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-1174CHILDRENS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85820SUPPL 2026-05-04
72133SUPPL2022-09-21
72119SUPPL2022-09-21
55368SUPPL2018-08-30
48843SUPPL2017-06-27
48798SUPPL2017-06-22
47702SUPPL2017-03-24
47666SUPPL2017-03-24
12785SUPPL2014-01-13
25250SUPPL2013-12-24
25249SUPPL2010-09-07
25248SUPPL2009-05-26
2801SUPPL2008-06-16
25247SUPPL2005-12-15
34899SUPPL2005-03-23
2800SUPPL2005-03-23
12784SUPPL2003-04-25