FDA.reportPublic FDA data

Application 201803

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADVILIBUPROFEN SODIUMTABLET;ORALEQ 200MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0133Advilibuprofen sodiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0133Advilibuprofen sodiumWyeth Consumer Healthcare LLCNDACurrent
0573-0133Advilibuprofen sodiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0133Advilibuprofen sodiumWyeth Consumer Healthcare LLCNDACurrent
0573-0133Advilibuprofen sodiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0134Advilibuprofen sodiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0134Advilibuprofen sodiumWyeth Consumer Healthcare LLCNDACurrent
0573-0134Advilibuprofen sodiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0134Advilibuprofen sodiumWyeth Consumer Healthcare LLCNDACurrent
0573-0134Advilibuprofen sodiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0230Advil Menstrual Painibuprofen sodiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0230Advil Menstrual Painibuprofen sodiumPfizer Consumer HealthcareNDACurrent
0573-0230Advil Menstrual Painibuprofen sodiumGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70131SUPPL2022-02-09
70130SUPPL2022-02-09
54412SUPPL2018-06-01
54404SUPPL2018-06-01
53788SUPPL2018-04-23
53691SUPPL2018-04-16
49542SUPPL2017-08-25
49534SUPPL2017-08-24
48717SUPPL2017-06-14
48710SUPPL2017-06-13
40087SUPPL2016-06-10
9930SUPPL2016-06-07
44837ORIG2012-11-29
22861ORIG2012-11-29
40086ORIG2012-08-30
32138ORIG2012-06-14