FDA.reportPublic FDA data

Application 022113

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADVIL ALLERGY AND CONGESTION RELIEFCHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDETABLET;ORAL4MG;200MG;10MGYesYes
002ADVIL MULTI-SYMPTOM COLD & FLUCHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDETABLET;ORAL4MG;200MG;10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0190Advil Multi-Symptom Cold and Fluchlorpheniramine maleate, ibuprofen, phenylephrine HClGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0190Advil Multi-Symptom Cold and Fluchlorpheniramine maleate, ibuprofen, phenylephrine HClWyeth Consumer Healthcare LLCNDACurrent
0573-0190Advil Multi-Symptom Cold and Fluchlorpheniramine maleate, ibuprofen, phenylephrine HClGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0190Advil Multi-Symptom Cold and Fluchlorpheniramine maleate, ibuprofen, phenylephrine HClWyeth Consumer Healthcare LLCNDACurrent
0573-0190Advil Multi-Symptom Cold and Fluchlorpheniramine maleate, ibuprofen, phenylephrine HClGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0190Advil Multi-Symptom Cold and Fluchlorpheniramine maleate, ibuprofen, phenylephrine HClGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0196Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, and phenylephrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0196Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloridePfizer Consumer HealthcareNDACurrent
0573-0196Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, and phenylephrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0196Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, and phenylephrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0196Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, and phenylephrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0196Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, and phenylephrine hydrochlorideWyeth Consumer Healthcare LLCNDACurrent
0573-0196Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, and phenylephrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2161Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, and phenylephrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2161Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, and phenylephrine hydrochlorideWyeth Consumer Healthcare LLCNDACurrent
0573-2161Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, and phenylephrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2161Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, and phenylephrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2161Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, and phenylephrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2161Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, and phenylephrine hydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
67751-149Advil Allergy and Congestion ReliefCHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.NDACurrent
67751-149Advil Allergy and Congestion ReliefCHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69425SUPPL2021-11-30
69409SUPPL2021-11-24
59954SUPPL2019-09-10
59953SUPPL2019-09-10
59303SUPPL2019-07-10
59299SUPPL2019-07-10
57524SUPPL2019-02-13
57453SUPPL2019-02-06
53018SUPPL2018-03-15
53017SUPPL2018-03-15
52782SUPPL2018-03-01
52781SUPPL2018-03-01
48213SUPPL2017-05-02
48171SUPPL2017-05-01
44682ORIG2012-09-06
42419ORIG2012-09-06
6912ORIG2011-12-28