Regulatory PathRegulatory requirements compared

Active substance

Trimethobenzamide

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
TIGAN100MG/MLinjectable · injectionPH HEALTHPrescription12 Jul 1974
TRIMETHOBENZAMIDE HYDROCHLORIDE300MGcapsule · oralLUPINPrescription20 Aug 2003
TRIMETHOBENZAMIDE HYDROCHLORIDE300MGcapsule · oralHERITAGE PHARMA AVETPrescription21 Nov 2023
TRIMETHOBENZAMIDE HYDROCHLORIDE100MG/MLinjectable · injectionBPI LABSPrescription16 Oct 2025
TIGAN300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralKING PHARMS LLCDiscontinued12 Jul 1974
TRIMETHOBENZAMIDE HYDROCHLORIDE100MG/MLinjectable · injectionWATSON LABSDiscontinued19 Oct 1982
TRIMETHOBENZAMIDE HYDROCHLORIDE100MG/MLinjectable · injectionWATSON LABSDiscontinued28 Dec 1982
TRIMETHOBENZAMIDE HYDROCHLORIDE100MG/MLinjectable · injectionHOSPIRADiscontinued3 Apr 1987
TRIMETHOBENZAMIDE HYDROCHLORIDE300MGcapsule · oralSUN PHARM INDUSTRIESDiscontinued28 Aug 2003
TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE100MG/MLinjectable · injectionAM REGENTDiscontinued8 Mar 2011
TRIMETHOBENZAMIDE HYDROCHLORIDE100MG/MLinjectable · injectionAM REGENTDiscontinued8 Mar 2011
TRIMETHOBENZAMIDE HYDROCHLORIDE100MG/MLinjectable · injectionSMITH AND NEPHEWDiscontinued
TRIMETHOBENZAMIDE HYDROCHLORIDE100MG/MLinjectable · injectionSMITH AND NEPHEWDiscontinued
TRIMETHOBENZAMIDE HYDROCHLORIDE100MG/MLinjectable · injectionSOLOPAKDiscontinued

Safety signals and safety-related labeling changes

All safety entries for trimethobenzamide →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.