Regulatory PathRegulatory requirements compared

Active substance

Fluphenazine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
FLUPHENAZINE DECANOATE 25MG-ML Injection*25 mg/mlSolution for injection · Intravenous use10 AmpouleSAR 128.75NCE · PrescriptionANTIGENWithdrawn by MAH · Not Marketed
FLUPHENAZINE DECANOATE OILY 100MG-ML AMP100 mg/mlInjection · Intramuscular use5 AmpouleSAR 107.85NCE · PrescriptionHOSPIRA AUSTRALIAWithdrawn by MAH · Not Marketed
FLUPHENAZINE DECANOATE OILY 25MG-ML AMP25 mg/mlInjection · Intramuscular use5 AmpouleSAR 64.40NCE · PrescriptionHOSPIRA AUSTRALIAWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
FLUPHENAZINE HYDROCHLORIDE2.5MG/MLinjectable · injectionFRESENIUS KABI USAPrescription16 Apr 1987
FLUPHENAZINE DECANOATE25MG/MLinjectable · injectionFRESENIUS KABI USAPrescription14 Jul 1987
FLUPHENAZINE HYDROCHLORIDE5MGtablet · oralSANDOZPrescription16 Oct 1987
FLUPHENAZINE HYDROCHLORIDE1MGtablet · oralLANNETTPrescription25 Aug 1988
FLUPHENAZINE HYDROCHLORIDE2.5MGtablet · oralLANNETTPrescription25 Aug 1988
FLUPHENAZINE HYDROCHLORIDE5MGtablet · oralLANNETTPrescription25 Aug 1988
FLUPHENAZINE HYDROCHLORIDE10MG; 1MG; 2.5MG; 5MGtablet · oralLANNETT CO INCPrescription25 Aug 1988
FLUPHENAZINE HYDROCHLORIDE2.5MG/5MLelixir · oralPHARM ASSOCPrescription21 Aug 1996
FLUPHENAZINE DECANOATE25MG/MLinjectable · injectionHIKMA PHARMSPrescription30 Aug 1996
FLUPHENAZINE HYDROCHLORIDE5MG/MLconcentrate · oralPHARM ASSOCPrescription16 Sep 1996
FLUPHENAZINE DECANOATE25MG/MLinjectable · injectionMYLAN LABS LTDPrescription17 Aug 2001
FLUPHENAZINE DECANOATE25MG/MLinjectable · injectionPH HEALTHPrescription3 Jul 2014
FLUPHENAZINE DECANOATE25MG/MLinjectable · injectionEUGIA PHARMAPrescription17 Oct 2017
FLUPHENAZINE HYDROCHLORIDE1MG; 2.5MG; 5MG; 10MGtablet · oralAMNEALPrescription9 Jul 2020
FLUPHENAZINE HYDROCHLORIDE1MG; 2.5MG; 5MG; 10MGtablet · oralDR REDDYSPrescription7 Jan 2021
FLUPHENAZINE HYDROCHLORIDE1MG; 2.5MG; 5MG; 10MGtablet · oralNOVITIUM PHARMAPrescription1 Mar 2021
FLUPHENAZINE HYDROCHLORIDE1MG; 2.5MG; 5MG; 10MGtablet · oralZYDUS LIFESCIENCESPrescription27 May 2021
FLUPHENAZINE HYDROCHLORIDE1MG; 2.5MG; 5MG; 10MGtablet · oralCHARTWELL RXPrescription20 Oct 2021
FLUPHENAZINE HYDROCHLORIDE1MG; 2.5MG; 5MG; 10MGtablet · oralTAROPrescription14 Apr 2022
FLUPHENAZINE HYDROCHLORIDE1MG; 2.5MG; 5MG; 10MGtablet · oralUPSHER SMITH LABSPrescription24 Oct 2022
FLUPHENAZINE HYDROCHLORIDE1MG; 2.5MG; 5MG; 10MGtablet · oralAJANTA PHARMA LTDPrescription5 Jan 2023
FLUPHENAZINE DECANOATE25MG/MLinjectable · injectionGLANDPrescription30 Mar 2023
FLUPHENAZINE HYDROCHLORIDE1MG; 2.5MG; 5MG; 10MGtablet · oralAUROBINDO PHARMA LTDPrescription18 Aug 2023
FLUPHENAZINE HYDROCHLORIDE1MG; 2.5MG; 5MG; 10MGtablet · oralMSNPrescription11 Sep 2023
FLUPHENAZINE DECANOATE25MG/MLinjectable · injectionMSNPrescription2 Nov 2023

29 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
FLUPHENAZINE004053451 MGTABLET · ORALAA PHARMA INC
FLUPHENAZINE004053615 MGTABLET · ORALAA PHARMA INC
FLUPHENAZINE004106322 MGTABLET · ORALAA PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFLUPHENAZINE 1 MG TABLET$0.2128per EA23 Sep 2026
US NADACFLUPHENAZINE 10 MG TABLET$0.43085per EA23 Sep 2026
US NADACFLUPHENAZINE 2.5 MG TABLET$0.22373per EA23 Sep 2026
US NADACFLUPHENAZINE 5 MG TABLET$0.14825per EA23 Sep 2026
US NADACFLUPHENAZINE DEC 125 MG/5 ML$10.84399per ML23 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.

WHO WHO Model List of Essential Medicines (2025)

  • 24.1. Medicines for psychotic disorders · core
    Schizophrenia or other primary psychotic disorders
    Parenteral > General injections > IM: 25 mg per mL in ampoule (decanoate); 25 mg per mL in ampoule (enanthate)

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.