FDA.reportPublic FDA data

Application 201803

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N201803-001ADVILIBUPROFEN SODIUMEQ 200MG BASETABLET / ORALRLD, RS2012-06-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N201803-001ADVILEQ 200MG BASETABLET / ORALRLD, RS2012-06-12a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AdvilIBUPROFEN SODIUMHaleon US Holdings LLC5be198b8-396e-4b44-8819-e2e3b5d2ad0e2025-10-03WarningsExact identifier
application applno (NDA): 201803
application number: NDA201803
ndc (product): 0573-0133
ndc (product): 0573-0134
Advil Menstrual PainIBUPROFEN SODIUMHaleon US Holdings LLCae1625f4-ef32-4d4f-bf54-c44085843e412024-01-31WarningsExact identifier
application applno (NDA): 201803
application number: NDA201803
ndc (product): 0573-0230

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

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