FDA.report

Application 020402

Type
NDA
Sponsor
GLAXOSMITHKLINE

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ADVIL LIQUI-GELSIBUPROFENCAPSULE;ORALEQ 200MG FREE ACID AND POTASSIUM SALTYesYes
002ADVIL MIGRAINE LIQUI-GELSIBUPROFENCAPSULE;ORALEQ 200MG FREE ACID AND POTASSIUM SALTYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0149AdvilibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0149AdvilibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0149AdvilibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0149AdvilibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0149AdvilibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0168ADVIL MIGRAINEibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0168ADVIL MIGRAINEibuprofenPfizer Consumer HealthcareNDACurrent
0573-0168ADVIL MIGRAINEibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0168ADVIL MIGRAINEibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0168ADVIL MIGRAINEibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0169AdvilibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0169AdvilibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0169AdvilibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0169AdvilibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0169AdvilibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-1769AdvilibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-1769AdvilibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-1769AdvilibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-1769AdvilibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-1769AdvilibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
29485-2893Advill Liqui-GelsIBUPROFEN Capsule, Liquid-filledMechanical Servants LLCNDACurrent
29485-2893Advill Liqui-GelsIBUPROFEN Capsule, Liquid-filledMechanical Servants LLCNDACurrent
29485-2893Advil Liqui-GelsIBUPROFEN Capsule, Liquid-filledMechanical Servants LLCNDACurrent
29485-2893Advil Liqui-GelsIBUPROFEN Capsule, Liquid-filledMechanical Servants LLCNDACurrent
29485-2893Advil Liqui-GelsIBUPROFEN Capsule, Liquid-filledMechanical Servants LLCNDACurrent
29485-2893Advil Liqui-GelsIBUPROFEN Capsule, Liquid-filledMechanical Servants LLCNDACurrent
29485-6939Advil Liqui-GelsIBUPROFEN Capsule, Liquid-filledMechanical Servants LLCNDACurrent
29485-6939Advil Liqui-GelsIBUPROFEN Capsule, Liquid-filledMechanical Servants LLCNDACurrent
29485-6939Advil Liqui-GelsIBUPROFEN Capsule, Liquid-filledMechanical Servants LLCNDACurrent
29485-6939Advil Liqui-GelsIBUPROFEN Capsule, Liquid-filledMechanical Servants LLCNDACurrent
29485-6939Advill Liqui-GelsIBUPROFEN Capsule, Liquid-filledMechanical Servants LLCNDACurrent
52904-793Advil Liqui-GelsIbuprofenSelect CorporationNDACurrent
66715-9752Advil Liqui-GelsIbuprofenLil Drug Store Products, IncNDACurrent
66715-9752Advil Liqui-GelsIbuprofenLil Drug Store Products, IncNDACurrent
66715-9752Advil Liqui-GelsIbuprofenLil Drug Store Products, IncNDACurrent
66715-9752Advil Liqui-GelsIbuprofenLil Drug Store Products, IncNDACurrent
67751-148Advil LiquigelsIBUPROFENNavajo Manufacturing Company Inc.NDACurrent
67751-148Advil LiquigelsIBUPROFENNavajo Manufacturing Company Inc.NDACurrent
67751-148Advil LiquigelsIBUPROFENNavajo Manufacturing Company Inc.NDACurrent

Documents

DocumentSubmission typeDate
83421SUPPL 2025-09-23
80827SUPPL 2025-01-10
73607SUPPL 2023-02-24
73603SUPPL 2023-02-24
70068SUPPL2022-02-03
55479SUPPL2018-09-14
55474SUPPL2018-09-13
55115SUPPL2018-08-03
55097SUPPL2018-08-03
50107SUPPL2017-10-19
49422SUPPL2017-08-15
49360SUPPL2017-08-15
49166SUPPL2017-08-01
49165SUPPL2017-08-01
34603SUPPL2015-12-22
2482SUPPL2015-12-18
34602SUPPL2015-07-09
2481SUPPL2011-04-22
24909SUPPL2009-07-15
24908SUPPL2009-05-26
2480SUPPL2008-06-17
2478SUPPL2006-05-02
2479SUPPL2006-02-22
2477SUPPL2004-02-27
20633SUPPL2003-07-08
24907SUPPL2000-03-16
12536SUPPL2000-03-16