FDA.reportPublic FDA data

Application 021373

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S ADVIL COLDIBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDESUSPENSION;ORAL100MG/5ML;15MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N021373-001CHILDREN'S ADVIL COLDIBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47868SUPPL2017-04-05
47863SUPPL2017-04-05
27633SUPPL2010-08-26
5221SUPPL2009-05-27
5220SUPPL2008-12-11
5219SUPPL2006-04-07
27632SUPPL2005-01-13
27631SUPPL2004-06-01
42127ORIG2002-04-18
27630ORIG2002-04-18
15339ORIG2002-04-18