Regulatory PathRegulatory requirements compared

Active substance

Promazine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
SPARINE50MG/ML; 25MG/MLinjectable · injectionHIKMADiscontinued13 Apr 1956
SPARINE25MG; 50MG; 100MG; 200MG; 10MGtablet · oralWYETH AYERSTDiscontinued8 Apr 1957
SPARINE30MG/ML; 100MG/MLconcentrate · oralWYETH AYERSTDiscontinued12 Nov 1957
SPARINE10MG/5MLsyrup · oralWYETH AYERSTDiscontinued12 Nov 1957
PROMAZINE HYDROCHLORIDE25MG/MLinjectable · injectionWATSON LABSDiscontinued
PROMAZINE HYDROCHLORIDE50MG/MLinjectable · injectionWATSON LABSDiscontinued

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
PROMAZINE 25MG TABLETSPL 00289/0798TEVA UK LIMITEDPOM
PROMAZINE 25MG/5ML ORAL SYRUPPL 00427/0054ROSEMONT PHARMACEUTICALS LIMITEDPOM
PROMAZINE 50MG TABLETSPL 00289/0799TEVA UK LIMITEDPOM
PROMAZINE 50MG/5ML ORAL SYRUPPL 00427/5014RROSEMONT PHARMACEUTICALS LIMITEDPOM
PROMAZINE HYDROCHLORIDE 25 MG/5 ML ORAL SYRUPPL 40546/0178ARISTO PHARMA GMBHPOM
PROMAZINE HYDROCHLORIDE 25 MG/5 ML ORAL SYRUPPL 58839/0070ZYDUS PHARMACEUTICALS UK LTDPOM
PROMAZINE HYDROCHLORIDE 50 MG/5 ML ORAL SYRUPPL 40546/0179ARISTO PHARMA GMBHPOM
PROMAZINE HYDROCHLORIDE 50 MG/5 ML ORAL SYRUPPL 58839/0071ZYDUS PHARMACEUTICALS UK LTDPOM

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffPromazine 25mg tablets£86.24100 tablet1 Oct 2026
NHS Drug TariffPromazine 25mg/5ml oral solution£79.50150 ml1 Oct 2026
NHS Drug TariffPromazine 50mg tablets£137.83100 tablet1 Oct 2026
NHS Drug TariffPromazine 50mg/5ml oral solution£102.24150 ml1 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.