FDA.reportPublic FDA data

Application 021394

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADVIL PMDIPHENHYDRAMINE CITRATE; IBUPROFENTABLET;ORAL38MG;200MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0164ADVIL PMdiphenhydramine citrate and ibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0164ADVIL PMdiphenhydramine citrate and ibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0164ADVIL PMdiphenhydramine citrate and ibuprofenWyeth Consumer Healthcare LLCNDACurrent
0573-0164ADVIL PMdiphenhydramine citrate and ibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0164Advil PMDiphenhydramine Citrate And IbuprofenWYETH CONSUMER HEALTHCARE LLCNDACurrent
0573-0164ADVIL PMdiphenhydramine citrate and ibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0164ADVIL PMdiphenhydramine citrate and ibuprofenWyeth Consumer Healthcare LLCNDACurrent
29485-6644ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coatedAdvil PMMechanical Servants LLCNDACurrent
29485-6644ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coatedAdvil PMMechanical Servants LLCNDACurrent
29485-7008ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coatedAdvil PMMechanical Servants LLCNDACurrent
29485-7008ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coatedAdvil PMMechanical Servants LLCNDACurrent
29485-7088ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coatedAdvil PMMechanical Servants LLCNDACurrent
29485-7088ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coatedAdvil PMMechanical Servants LLCNDACurrent
29485-7937ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coatedAdvil PMMechanical Servants LLCNDACurrent
29485-7937ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coatedAdvil PMMechanical Servants LLCNDACurrent
66715-9733Advil PMIbuprofen and Diphenhydramine citrateLil' Drug Store Products, Inc.NDACurrent
66715-9733Advil PMIbuprofen and Diphenhydramine citrateLil' Drug Store Products, Inc.NDACurrent
66715-9733Advil PMIbuprofen and Diphenhydramine citrateLil' Drug Store Products, Inc.NDACurrent
67751-147Advil PMDIPHENHYDRAMINE CITRATE, IBUPROFENNavajo Manufacturing Company Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73592SUPPL 2023-02-22
73590SUPPL 2023-02-22
69838SUPPL2022-01-11
69837SUPPL2022-01-11
56101SUPPL2018-10-26
55929SUPPL2018-10-15
53789SUPPL2018-04-23
53765SUPPL2018-04-20
49084SUPPL2017-07-26
49074SUPPL2017-07-25
47862SUPPL2017-04-05
47819SUPPL2017-04-03
27655SUPPL2011-04-28
27656SUPPL2010-09-07
5242SUPPL2009-05-27
27654SUPPL2008-06-13
21632ORIG2006-09-07
27653ORIG2006-01-19
36811ORIG2006-01-05