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 43.

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 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-0184e616aacf4f…
2026-09-14 22:38:342026-08N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-0184e616aacf4f…
2026-09-14 22:38:342026-08N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-1884e616aacf4f…
2026-08-18 06:07:402026-07N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01caaa826d4ba7…
2026-08-18 06:07:402026-07N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01caaa826d4ba7…
2026-08-18 06:07:402026-07N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N050590-002TIMENTINEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N050590-003TIMENTINEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALINJECTABLE / INJECTION1987-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050590-001TIMENTINEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALINJECTABLE / INJECTION1985-04-0179d66fd596c7…
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…

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