Regulatory PathRegulatory requirements compared

Active substance

Clorazepate

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
TRANXENE7.5MGtablet · oralAJENAT PHARMSPrescription23 Jun 1972
CLORAZEPATE DIPOTASSIUM15MG; 3.75MG; 7.5MGtablet · oralAUROBINDO PHARMAPrescription17 Jul 1987
CLORAZEPATE DIPOTASSIUM15MG; 7.5MG; 3.75MGtablet · oralTAROPrescription27 Apr 2000
CLORAZEPATE DIPOTASSIUM3.75MG; 7.5MG; 15MGtablet · oralCOREPHARMAPrescription14 Jun 2022
CLORAZEPATE DIPOTASSIUM3.75MG; 7.5MG; 15MGtablet · oralNOVITIUM PHARMAPrescription16 Jun 2022
TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralAJENAT PHARMSDiscontinued23 Jun 1972
TRANXENE SD22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralAJENAT PHARMSDiscontinued23 Jun 1972
TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralAJENAT PHARMSDiscontinued23 Jun 1972
CLORAZEPATE DIPOTASSIUM3.75MGtablet · oralABLEDiscontinued26 Jun 1987
CLORAZEPATE DIPOTASSIUM7.5MGtablet · oralABLEDiscontinued26 Jun 1987
CLORAZEPATE DIPOTASSIUM15MGtablet · oralABLEDiscontinued26 Jun 1987
CLORAZEPATE DIPOTASSIUM3.75MGcapsule · oralABLEDiscontinued14 Jul 1987
CLORAZEPATE DIPOTASSIUM7.5MGcapsule · oralABLEDiscontinued14 Jul 1987
CLORAZEPATE DIPOTASSIUM15MGcapsule · oralABLEDiscontinued14 Jul 1987
CLORAZEPATE DIPOTASSIUM3.75MGcapsule · oralNATCO PHARMA USADiscontinued19 Oct 1987
CLORAZEPATE DIPOTASSIUM7.5MGcapsule · oralNATCO PHARMA USADiscontinued19 Oct 1987
CLORAZEPATE DIPOTASSIUM15MGcapsule · oralNATCO PHARMA USADiscontinued19 Oct 1987
CLORAZEPATE DIPOTASSIUM3.75MGcapsule · oralDAVA PHARMS INCDiscontinued14 Dec 1987
CLORAZEPATE DIPOTASSIUM7.5MGcapsule · oralDAVA PHARMS INCDiscontinued14 Dec 1987
CLORAZEPATE DIPOTASSIUM15MGcapsule · oralDAVA PHARMS INCDiscontinued14 Dec 1987
CLORAZEPATE DIPOTASSIUM3.75MGcapsule · oralGD SEARLE LLCDiscontinued18 Dec 1987
CLORAZEPATE DIPOTASSIUM7.5MGcapsule · oralGD SEARLE LLCDiscontinued18 Dec 1987
CLORAZEPATE DIPOTASSIUM15MGcapsule · oralGD SEARLE LLCDiscontinued18 Dec 1987
CLORAZEPATE DIPOTASSIUM3.75MGtablet · oralWATSON LABSDiscontinued9 Feb 1988
CLORAZEPATE DIPOTASSIUM7.5MGtablet · oralWATSON LABSDiscontinued9 Feb 1988

42 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CLORAZEPATE008606893.75 MGCAPSULE · ORALAA PHARMA INC
CLORAZEPATE0086069715 MGCAPSULE · ORALAA PHARMA INC
CLORAZEPATE008607007.5 MGCAPSULE · ORALAA PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCLORAZEPATE 15 MG TABLET$0.80796per EA23 Sep 2026
US NADACCLORAZEPATE 3.75 MG TABLET$0.52409per EA23 Sep 2026
US NADACCLORAZEPATE 7.5 MG TABLET$0.83861per EA23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for clorazepate →

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.