FDA.reportPublic FDA data

Application 017531

Type
NDA
Sponsor
KING PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
006TIGANTRIMETHOBENZAMIDE HYDROCHLORIDECAPSULE;ORAL300MGYesYes

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
N017531-006TIGANTRIMETHOBENZAMIDE HYDROCHLORIDE300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-12-13

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 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2022-10-28 04:53 UTC2022-10N017531-006TIGAN300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-12-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017531-006TIGAN300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-12-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017531-006TIGAN300MGCAPSULE / ORALRLD2001-12-13cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017531-006TIGAN300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-12-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N017531-006AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017531-006AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N017531-006AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017531-006AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017531-006AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017531-006AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N017531-006AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017531-006AB1ea99ee380514…

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
generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE
TiganTRIMETHOBENZAMIDE HYDROCHLORIDEPar Health USA, LLC7da90678-b229-4ad6-9193-2b8a3e9ba6952026-03-10Warnings, Adverse reactionsName fallback
brand name: Tigan
generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE
Trimethobenzamide HydrochlorideTRIMETHOBENZAMIDE HYDROCHLORIDEChartwell RX, LLCee626da9-cffc-4bb9-a528-482687201b2a2025-12-11Warnings, Adverse reactionsName fallback
generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE
TiganTRIMETHOBENZAMIDE HYDROCHLORIDEHenry Schein, Inc147def93-cd3d-4e42-89ad-6a6b413bf3622025-10-14Warnings, Adverse reactionsName fallback
brand name: Tigan
generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE
Trimethobenzamide HydrochlorideTRIMETHOBENZAMIDE HYDROCHLORIDEBryant Ranch Prepack00ba5395-1455-4ea9-9278-e3749979526c2024-04-04Warnings, Adverse reactionsName fallback
generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE
Trimethobenzamide HydrochlorideTRIMETHOBENZAMIDE HYDROCHLORIDELupin Pharmaceuticals,Inc.c18073be-d52a-4347-a8d1-6be11bcb78242024-01-30Warnings, Adverse reactionsName fallback
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
generic name: TRIMETHOBENZAMIDE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61570-079TIGANtrimethobenzamide hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
61570-079TIGANtrimethobenzamide hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
61570-079TIGANtrimethobenzamide hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
70518-1225TIGANtrimethobenzamide hydrochlorideREMEDYREPACK INC.NDACurrent
70518-1225TIGANtrimethobenzamide hydrochlorideREMEDYREPACK INC.NDACurrent
70518-1225TIGANtrimethobenzamide hydrochlorideREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47565SUPPL2017-03-14
47564SUPPL2017-03-14
13833SUPPL2008-12-10
33293SUPPL2008-12-08
11015SUPPL2008-03-27
13832SUPPL2008-03-26
20076SUPPL2007-07-06
11014SUPPL2002-04-30
619SUPPL2002-04-30