Regulatory PathRegulatory requirements compared

Active substance

Acamprosate

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
ACAMPROSATE CALCIUM333MGtablet, delayed release · oralGLENMARK PHARMS LTDPrescription16 Jul 2013
ACAMPROSATE CALCIUM333MGtablet, delayed release · oralMYLANPrescription11 Mar 2014
ACAMPROSATE CALCIUM333MGtablet, delayed release · oralZYDUS PHARMSPrescription26 May 2017
ACAMPROSATE CALCIUM333MGtablet, delayed release · oralBIONPHARMAPrescription18 Sep 2025
ACAMPROSATE CALCIUM333MGtablet, delayed release · oralSOMERSET THERAPS LLCPrescription16 Mar 2026
CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet, delayed release · oralFOREST LABSDiscontinued29 Jul 2004
ACAMPROSATE CALCIUM333MGtablet, delayed release · oralBARR LABS DIV TEVADiscontinued18 Nov 2013

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CAMPRAL02293269333 MGTABLET (DELAYED-RELEASE) · ORALMYLAN PHARMACEUTICALS ULC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffAcamprosate 333mg gastro-resistant tablets£22.04168 tablet1 Oct 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.

WHO WHO Model List of Essential Medicines (2025)

  • 24.5.1. Medicines for alcohol use disorders · core
    Disorders due to use of alcohol
    Oral > Solid > tablet: 333 mg

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.