FDA.report

Application 018989

Type
NDA
Sponsor
GLAXOSMITHKLINE

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ADVILIBUPROFENTABLET;ORAL200MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0150ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0150ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0150ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0150ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0150ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0150ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0151ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0151ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0151ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0151ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0151ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0151ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0154ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0154ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0154ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0154ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0154ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0154ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0160ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0160ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0160ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0160ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0160ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0160ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0161ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0161ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0161ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0161ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0161ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0161ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0165ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0165ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0165ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0165ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0165ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0165ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0166ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0166ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0166ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0166ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0166ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0166ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-1711ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-1711ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-1711ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-1711ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-1711ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-1711ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
29485-1005ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-1005ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-1005ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-6500ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-6749ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-6749ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-6749ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-7012ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-7012ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
29485-7012ADVILIBUPROFEN Tablet coatedMechanical Servants LLCNDACurrent
52904-786ADVILibuprofenWyeth Pharmaceuticals CompanyNDACurrent
52904-790ADVILibuprofenWyeth Pharmaceuticals CompanyNDACurrent
52904-791ADVILibuprofenWyeth Pharmaceuticals CompanyNDACurrent
52904-794ADVILibuprofenWyeth Pharmaceuticals CompanyNDACurrent
66715-5803AdvilIbuprofen Tablets, coatedLil' Drug Store Products, Inc.NDACurrent
66715-9700AdvilIbuprofenLil' Drug Store Products, Inc.NDACurrent
66715-9700AdvilIbuprofenLil' Drug Store Products, Inc.NDACurrent
66715-9700AdvilIbuprofenLil' Drug Store Products, Inc.NDACurrent
66715-9700AdvilIbuprofenLil' Drug Store Products, Inc.NDACurrent
66715-9700AdvilIbuprofenLil' Drug Store Products, Inc.NDACurrent
67751-146AdvilIBUPROFENNavajo Manufacturing Company Inc.NDACurrent
67751-146AdvilIBUPROFENNavajo Manufacturing Company Inc.NDACurrent

Documents

DocumentSubmission typeDate
81685SUPPL 2025-03-24
80803SUPPL 2025-01-02
69581SUPPL2021-12-16
69580SUPPL2021-12-16
56483SUPPL2018-11-23
56489SUPPL2018-11-16
55926SUPPL2018-10-15
55882SUPPL2018-10-11
49622SUPPL2017-08-30
49575SUPPL2017-08-29
11407SUPPL2015-12-22
1186SUPPL2015-12-18
33680SUPPL2012-03-27
1184SUPPL2011-04-28
1185SUPPL2010-09-07
16163SUPPL2009-05-26
1183SUPPL2008-06-13
16162SUPPL2007-05-07
11406SUPPL2007-05-07
16161SUPPL2006-04-20
1182SUPPL2006-04-07
1181SUPPL2004-07-21
16159SUPPL2004-05-26
11404SUPPL2004-05-26
16160SUPPL2003-09-30
11405SUPPL2003-09-30
11403SUPPL2003-04-23