FDA.reportPublic FDA data

Application 017530

Type
NDA
Sponsor
PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIGANTRIMETHOBENZAMIDE HYDROCHLORIDEINJECTABLE;INJECTION100MG/MLYesYes

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
N017530-001TIGANTRIMETHOBENZAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N017530-001AP

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 UTC2022-10N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N017530-001AP1c2088c7a36db…
2026-09-14 22:38:342026-08N017530-001AP184e616aacf4f…
2026-08-18 06:07:402026-07N017530-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017530-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017530-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017530-001AP1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TiganTRIMETHOBENZAMIDE HYDROCHLORIDEPar Health USA, LLC7da90678-b229-4ad6-9193-2b8a3e9ba6952026-03-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 017530
application number: NDA017530
ndc (product): 42023-119
TiganTRIMETHOBENZAMIDE HYDROCHLORIDEHenry Schein, Inc147def93-cd3d-4e42-89ad-6a6b413bf3622025-10-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 017530
application number: NDA017530
ndc (product): 0404-9964
TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)HF Acquisition Co LLC, DBA HealthFirst9bd0bfa0-c189-751c-e053-2a95a90a5f5a2024-01-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 017530
application number: NDA017530
ndc (product): 51662-1430

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9964TiganTrimethobenzamide HydrochlorideHenry Schein, IncNDACurrent
0404-9964TiganTrimethobenzamide HydrochlorideHenry Schein, IncNDACurrent
21695-853Tigantrimethobenzamide hydrochlorideRebel Distributors CorpNDACurrent
42023-118Tigantrimethobenzamide hydrochloridePar Pharmaceutical, Inc.NDACurrent
42023-118Tigantrimethobenzamide hydrochloridePar Pharmaceutical, Inc.NDACurrent
42023-119Tigantrimethobenzamide hydrochloridePar Pharmaceutical, Inc.NDACurrent
42023-119Tigantrimethobenzamide hydrochloridePar Pharmaceutical, Inc.NDACurrent
51662-1430TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1430TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1430TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
52584-119TiganTrimethobenzamide HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-119TiganTrimethobenzamide HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-119TiganTrimethobenzamide HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-119TiganTrimethobenzamide HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-119TiganTrimethobenzamide HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
11013SUPPL2008-06-05
13831SUPPL2008-04-22
40746SUPPL2007-07-09
33292SUPPL2005-08-31
13830SUPPL2005-08-31
11012SUPPL2005-08-31
11011SUPPL2005-08-31
618SUPPL2005-08-31
617SUPPL2005-08-31
13168SUPPL2004-06-18
11010SUPPL2004-06-18