Regulatory PathRegulatory requirements compared

Active substance

Demeclocycline

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
DEMECLOCYCLINE HYDROCHLORIDE150MG; 300MGtablet · oralAMNEAL PHARMPrescription27 Feb 2008
DEMECLOCYCLINE HYDROCHLORIDE150MG; 300MGtablet · oralEPIC PHARMA LLCPrescription1 Dec 2008
DEMECLOCYCLINE HYDROCHLORIDE150MG; 300MGtablet · oralEPIC PHARMA LLCPrescription18 Aug 2015
DECLOMYCIN150MGcapsule · oralLEDERLEDiscontinued14 Jan 1960
DECLOMYCIN75MG/5MLsyrup · oralLEDERLEDiscontinued14 Nov 1960
DECLOMYCIN75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralCOREPHARMADiscontinued22 Sep 1964
DEMECLOCYCLINE HYDROCHLORIDE150MG; 300MGtablet · oralIMPAX LABSDiscontinued22 Mar 2004
DEMECLOCYCLINE HYDROCHLORIDE150MG; 300MGtablet · oralBARRDiscontinued13 Dec 2004

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
DEMECLOCYCLINE HYDROCHLORIDE 150MG CAPSULESPL 12762/0154MERCURY PHARMACEUTICALS LIMITEDPOM
DEMECLOCYCLINE HYDROCHLORIDE DAWA 150 MG CAPSULESPL 30684/0304DAWA LIMITEDPOM
DEMECLOCYCLINE HYDROCHLORIDE DAWA 300MG CAPSULESPL 30684/0305DAWA LIMITEDPOM
LEDERMYCIN CAPSULES 150MGPL 12762/0154MERCURY PHARMACEUTICALS LIMITEDPOM

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACDEMECLOCYCLINE 150 MG TABLET$2.27261per EA23 Sep 2026
US NADACDEMECLOCYCLINE 300 MG TABLET$3.04571per EA23 Sep 2026
NHS Drug TariffDemeclocycline 150mg capsules£238.4128 capsule1 Oct 2026
NHS Drug TariffDemeclocycline 300mg capsules£452.9828 capsule1 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.

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.