FDA.reportPublic FDA data

Application 021128

Type
NDA
Sponsor
J AND J CONSUMER INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021128-001CHILDREN'S MOTRIN COLDIBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE100MG/5ML;15MG/5MLSUSPENSION / ORALRLD, RS2000-08-01

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N021128-001CHILDREN'S MOTRIN COLD100MG/5ML;15MG/5MLSUSPENSION / ORALRLD, RS2000-08-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021128-001CHILDREN'S MOTRIN COLD100MG/5ML;15MG/5MLSUSPENSION / ORALRLD, RS2000-08-01cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021128-001CHILDREN'S MOTRIN COLD100MG/5ML;15MG/5MLSUSPENSION / ORALRLD, RS2000-08-01a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021128-00162112462019-06-1074a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021128-00162112462019-06-103f01610625f2…
2019-09-15 20:21 UTC2019-09N021128-00162112462019-06-10b00525d2431f…
2019-07-19 19:46 UTC2019-07N021128-00162112462019-06-10ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49901SUPPL2017-10-02
26837SUPPL2009-05-06
26836SUPPL2006-01-19
4394SUPPL2005-04-28
21463ORIG2004-03-10
26835SUPPL2003-12-23