FDA.reportPublic FDA data

Application 211733

Type
NDA
Sponsor
PFIZER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADVIL DUAL ACTION WITH ACETAMINOPHENACETAMINOPHEN; IBUPROFENTABLET;ORAL250MG;125MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0147ADVIL DUAL ACTION WITH ACETAMINOPHENIbuprofen, AcetaminophenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0147ADVIL DUAL ACTION WITH ACETAMINOPHENIbuprofen, AcetaminophenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0147ADVIL DUAL ACTION WITH ACETAMINOPHENIbuprofen, AcetaminophenWyeth Consumer Healthcare LLCNDACurrent
0573-0147ADVIL DUAL ACTION WITH ACETAMINOPHENIbuprofen, AcetaminophenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
67751-211ADVIL DUAL ACTION WITH ACETAMINOPHENIbuprofen, AcetaminophenNavajo Manufacturing Company Inc.NDACurrent
67751-211ADVIL DUAL ACTION WITH ACETAMINOPHENIbuprofen, AcetaminophenNavajo Manufacturing Company Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82170SUPPL 2025-06-02
82169SUPPL 2025-05-08
70067SUPPL2022-02-03
69979SUPPL2022-01-27
69836SUPPL2022-01-11
69835SUPPL2022-01-11
62395ORIG2020-03-31
62010ORIG2020-02-28
62009ORIG2020-02-28