FDA.reportPublic FDA data

Application 050658

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIMENTIN IN PLASTIC CONTAINERCLAVULANATE POTASSIUM; TICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 100MG BASE/100ML;EQ 3GM BASE/100MLNoNo

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
N050658-001TIMENTIN IN PLASTIC CONTAINERCLAVULANATE POTASSIUM; TICARCILLIN DISODIUMEQ 100MG BASE/100ML;EQ 3GM BASE/100MLINJECTABLE / INJECTION1989-12-15

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 UTC2022-10N050658-001TIMENTIN IN PLASTIC CONTAINEREQ 100MG BASE/100ML;EQ 3GM BASE/100MLINJECTABLE / INJECTION1989-12-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050658-001TIMENTIN IN PLASTIC CONTAINEREQ 100MG BASE/100ML;EQ 3GM BASE/100MLINJECTABLE / INJECTION1989-12-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050658-001TIMENTIN IN PLASTIC CONTAINEREQ 100MG BASE/100ML;EQ 3GM BASE/100MLINJECTABLE / INJECTION1989-12-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050658-001TIMENTIN IN PLASTIC CONTAINEREQ 100MG BASE/100ML;EQ 3GM BASE/100MLINJECTABLE / INJECTION1989-12-15a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
17981SUPPL2014-06-17
7943SUPPL2014-06-17
30232SUPPL2013-10-01
17980SUPPL2013-10-01
30231SUPPL2012-10-09
17979SUPPL2012-10-05
17978SUPPL2011-06-14
7942SUPPL2011-06-13
7941SUPPL2010-12-28
17977SUPPL2010-12-26
7940SUPPL2008-12-19
17976SUPPL2008-06-05
30230SUPPL2008-04-22
30229SUPPL2007-03-23
17975SUPPL2007-03-16
7939SUPPL2004-12-02
7938SUPPL2002-03-18