Application 020267

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002JUNIOR STRENGTH ADVILIBUPROFENTABLET;ORAL100MGNoNo

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
N020267-002JUNIOR STRENGTH ADVILIBUPROFEN100MGTABLET / ORAL1996-12-13

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-1387673890dc5c…
2021-03-12 10:30 UTC2021-03N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-133f01610625f2…
2019-09-15 20:21 UTC2019-09N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13b00525d2431f…
2019-07-19 19:46 UTC2019-07N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-133f0d92c62455…
2023-05-13 08:27 UTC2023-05N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13053a50430f4f…
2023-01-26 05:58 UTC2023-01N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020267-002JUNIOR STRENGTH ADVIL100MGTABLET / ORAL1996-12-13cb3db0bc1861…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JUNIOR STRENGTH ADVILIBUPROFENHaleon US Holdings LLC5ed0d404-c54d-b05f-578a-d2730e8a78ee2024-04-22WarningsExact identifier
application applno (NDA): 020267
application number: NDA020267
ndc (product): 0573-0175

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-0175JUNIOR STRENGTH ADVILibuprofenGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-0175JUNIOR STRENGTH ADVILibuprofenWyeth Consumer Healthcare LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47861SUPPL2017-04-05
47826SUPPL2017-04-03
20577SUPPL2013-04-18
24696SUPPL2009-05-29
24695SUPPL2008-06-23
2272SUPPL2006-01-20
24694SUPPL2004-09-03