FDA.reportPublic FDA data

Application 020812

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PEDIATRIC ADVILIBUPROFENSUSPENSION/DROPS;ORAL100MG/2.5MLYesNo
002INFANT'S ADVILIBUPROFENSUSPENSION/DROPS;ORAL50MG/1.25MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0191INFANTS ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0191INFANTS ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0191INFANTS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0191INFANTS ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48950SUPPL2017-07-11
48941SUPPL2017-07-11
47748SUPPL2017-03-29
47744SUPPL2017-03-29
35394SUPPL2013-08-05
25884SUPPL2013-07-26
41717SUPPL2013-05-10
20972SUPPL2013-04-18
3403SUPPL2011-04-28
25883SUPPL2009-05-27
25882SUPPL2008-06-16
35393SUPPL2006-07-18
3402SUPPL2006-04-07
20971ORIG2005-06-23
3401SUPPL2004-09-15