FDA.reportPublic FDA data

Application 088960

Type
ANDA
Sponsor
SMITH AND NEPHEW

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIMETHOBENZAMIDE HYDROCHLORIDETRIMETHOBENZAMIDE HYDROCHLORIDEINJECTABLE;INJECTION100MG/MLNoNo

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
A088960-001TRIMETHOBENZAMIDE HYDROCHLORIDETRIMETHOBENZAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTION1986-04-04

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 UTC2022-10A088960-001TRIMETHOBENZAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTION1986-04-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088960-001TRIMETHOBENZAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTION1986-04-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088960-001TRIMETHOBENZAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTION1986-04-04cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A088960-001TRIMETHOBENZAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTION1986-04-04a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trimethobenzamide HydrochlorideTRIMETHOBENZAMIDE HYDROCHLORIDEBPI Labs, LLCa9a661ca-87ca-4c96-88ef-58fcaae233b52026-08-07Warnings, Adverse reactionsName fallback
brand name: Trimethobenzamide Hydrochloride
generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE
TiganTRIMETHOBENZAMIDE HYDROCHLORIDEPar Health USA, LLC7da90678-b229-4ad6-9193-2b8a3e9ba6952026-03-10Warnings, Adverse reactionsName fallback
generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE
Trimethobenzamide HydrochlorideTRIMETHOBENZAMIDE HYDROCHLORIDEChartwell RX, LLCee626da9-cffc-4bb9-a528-482687201b2a2025-12-11Warnings, Adverse reactionsName fallback
brand name: Trimethobenzamide Hydrochloride
generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE
TiganTRIMETHOBENZAMIDE HYDROCHLORIDEHenry Schein, Inc147def93-cd3d-4e42-89ad-6a6b413bf3622025-10-14Warnings, Adverse reactionsName fallback
generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE
Trimethobenzamide HydrochlorideTRIMETHOBENZAMIDE HYDROCHLORIDEBryant Ranch Prepack00ba5395-1455-4ea9-9278-e3749979526c2024-04-04Warnings, Adverse reactionsName fallback
brand name: Trimethobenzamide Hydrochloride
generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE
Trimethobenzamide HydrochlorideTRIMETHOBENZAMIDE HYDROCHLORIDELupin Pharmaceuticals,Inc.c18073be-d52a-4347-a8d1-6be11bcb78242024-01-30Warnings, Adverse reactionsName fallback
brand name: Trimethobenzamide Hydrochloride
generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE
Trimethobenzamide HydrochlorideTRIMETHOBENZAMIDE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.b0aa9b7e-bbe7-482e-81d3-d9658d5ac21f2023-11-21Warnings, Adverse reactionsName fallback
brand name: Trimethobenzamide Hydrochloride
generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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