FDA.reportPublic FDA data

Application 020944

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S ADVILIBUPROFENTABLET, CHEWABLE;ORAL50MGNoNo
002JUNIOR STRENGTH ADVILIBUPROFENTABLET, CHEWABLE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0179JUNIOR STRENGTH ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0179JUNIOR STRENGTH ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
71205-425JUNIOR STRENGTH ADVILibuprofenProficient Rx LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85821SUPPL 2026-05-04
47766SUPPL2017-03-29
47743SUPPL2017-03-28
41827SUPPL2013-04-18
21296SUPPL2013-04-18
3821SUPPL2009-05-27
3820SUPPL2008-06-13
26266SUPPL2006-04-07
26265SUPPL2004-12-30
3819SUPPL2004-12-30
21295ORIG2004-05-26
35691ORIG1998-12-18
3818ORIG1998-12-18