FDA.reportPublic FDA data

Application 021393

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADVIL PMDIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFENCAPSULE;ORAL25MG;EQ 200MG FREE ACID AND POTASSIUM SALTYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0167ADVIL PMdiphenhydramine HCl, ibuprofenPfizer Consumer HealthcareNDACurrent
0573-0167ADVIL PMdiphenhydramine HCl, ibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0167ADVIL PMdiphenhydramine HCl, ibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0167ADVIL PMdiphenhydramine HCl, ibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79574SUPPL 2024-09-10
79573SUPPL 2024-09-10
69843SUPPL2022-01-12
69842SUPPL2022-01-12
54316SUPPL2018-05-23
54072SUPPL2018-05-10
47860SUPPL2017-04-05
47830SUPPL2017-04-03
36810SUPPL2013-03-22
27652SUPPL2013-03-21
5241SUPPL2011-04-21
27651SUPPL2009-05-27
27650SUPPL2008-06-16
42135ORIG2006-09-07
5240ORIG2006-01-19
15353ORIG2006-01-05