FDA.reportPublic FDA data

Application 050590

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIMENTINCLAVULANATE POTASSIUM; TICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALNoNo
002TIMENTINCLAVULANATE POTASSIUM; TICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALNoNo
003TIMENTINCLAVULANATE POTASSIUM; TICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050590-001TIMENTINCLAVULANATE POTASSIUM; TICARCILLIN DISODIUMEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01
N050590-002TIMENTINCLAVULANATE POTASSIUM; TICARCILLIN DISODIUMEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01
N050590-003TIMENTINCLAVULANATE POTASSIUM; TICARCILLIN DISODIUMEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-18

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 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01782e0a99824c…
2021-12-28 21:50 UTC2021-12N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01782e0a99824c…
2021-12-28 21:50 UTC2021-12N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-0187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-0187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-015aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-015aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-018869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-018869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01c0c555d07b60…
2020-11-12 02:37 UTC2020-11N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01c0c555d07b60…

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
17912SUPPL2014-06-17
7861SUPPL2014-06-17
17911SUPPL2013-10-01
7860SUPPL2013-10-01
30137SUPPL2012-10-09
39018SUPPL2012-10-05
17910SUPPL2011-06-14
17909SUPPL2011-06-14
30136SUPPL2011-06-13
30135SUPPL2011-06-13
30134SUPPL2010-12-28
7859SUPPL2010-12-28
39017SUPPL2010-12-26
17908SUPPL2010-12-26
30133SUPPL2008-12-19
39016SUPPL2008-06-05
7858SUPPL2008-04-22
30132SUPPL2007-03-23
39015SUPPL2007-03-16
30131SUPPL2004-12-02
30129SUPPL2002-05-17
30130SUPPL2002-03-18