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 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
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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-1884e616aacf4f…
2026-08-18 06:07:402026-07N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-183f01610625f2…
2019-09-15 20:21 UTC2019-09N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021373-001CHILDREN'S ADVIL COLD100MG/5ML;15MG/5MLSUSPENSION / ORAL2002-04-18f41ea6bd6efb…

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