Regulatory PathRegulatory requirements compared

Active substance

Quetiapine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ADAZIO 100 mg film-coated tablet100 mgFilm-coated tablet · Oral use60 BlisterSAR 75.95Generic · PrescriptionRIYADH PHARMAValid
ADAZIO 200 mg film-coated tablet200 mgFilm-coated tablet · Oral use60 BlisterSAR 151.90Generic · PrescriptionRIYADH PHARMAValid
ADAZIO 25 mg film-coated tablet25 mgFilm-coated tablet · Oral use20 BlisterSAR 22.20Generic · PrescriptionRIYADH PHARMAValid
ADAZIO 300 mg film-coated tablet300 mgFilm-coated tablet · Oral use30 BlisterSAR 113.95Generic · PrescriptionRIYADH PHARMAValid
ATAPINA 100MG FILM COATED TABLET100 mgFilm-coated tablet · Oral use60 BlisterSAR 93.75Generic · PrescriptionDEEF PHARMACEUTICAL INDUSTRIESValid
ATAPINA 200MG FILM COATED TABLET200 mgFilm-coated tablet · Oral use60 BlisterSAR 187.55Generic · PrescriptionDEEF PHARMACEUTICAL INDUSTRIESValid
ATAPINA 25MG FILM COATED TABLET25 mgFilm-coated tablet · Oral use20 BlisterSAR 27.40Generic · PrescriptionDEEF PHARMACEUTICAL INDUSTRIESValid
ATAPINA 300MG FILM COATED TABLET300 mgFilm-coated tablet · Oral use30 BlisterSAR 140.65Generic · PrescriptionDEEF PHARMACEUTICAL INDUSTRIESValid
Adazio25 mgFilm-coated tablet · Oral use30 BlisterSAR 33.30Generic · PrescriptionRIYADH PHARMAValid
ESPERAL 100 mg Film Coated Tablet100 mgFilm-coated tablet · Oral use60 BlisterSAR 46.90Generic · PrescriptionDAR ALDAWAValid
ESPERAL 200 mg Film Coated Tablet200 mgFilm-coated tablet · Oral use60 BlisterSAR 87.00Generic · PrescriptionDAR ALDAWAValid
ESPERAL 25 mg Film Coated Tablet25 mgFilm-coated tablet · Oral use60 BlisterSAR 19.90Generic · PrescriptionDAR ALDAWAValid
ESPERAL 300 mg Film Coated Tablet300 mgFilm-coated tablet · Oral use30 BlisterSAR 71.40Generic · PrescriptionDAR ALDAWAValid
Phreno XR400 mgProlonged-release tablet · Oral use30 BlisterSAR 88.90Generic · PrescriptionMed City PharmaValid
Phreno XR400 mgProlonged-release tablet · Oral use60 BlisterSAR 177.80Generic · PrescriptionMed City PharmaValid
Phreno XR300 mgProlonged-release tablet · Oral use30 BlisterSAR 56.15Generic · PrescriptionMed City PharmaValid
Phreno XR300 mgProlonged-release tablet · Oral use60 BlisterSAR 112.35Generic · PrescriptionMed City PharmaValid
Phreno XR200 mgProlonged-release tablet · Oral use30 BlisterSAR 41.40Generic · PrescriptionMed City PharmaValid
Phreno XR200 mgProlonged-release tablet · Oral use60 BlisterSAR 67.70Generic · PrescriptionMed City PharmaValid
Phreno XR50 mgProlonged-release tablet · Oral use30 BlisterSAR 13.20Generic · PrescriptionMed City PharmaValid
Phreno XR50 mgProlonged-release tablet · Oral use60 BlisterSAR 26.40Generic · PrescriptionMed City PharmaValid
QATPEN 100MG F.C.TABLET100 mgFilm-coated tablet · Oral use30 BlisterSAR 34.15Generic · PrescriptionDAMMAM PHARMAValid
QATPEN 150MG F.C.TABLET150 mgFilm-coated tablet · Oral use30 BlisterSAR 51.25Generic · PrescriptionDAMMAM PHARMAValid
QATPEN 200MG F.C.TABLET200 mgFilm-coated tablet · Oral use30 BlisterSAR 68.35Generic · PrescriptionDAMMAM PHARMAValid
QATPEN 25MG F.C.TABLET25 mgFilm-coated tablet · Oral use30 BlisterSAR 29.95Generic · PrescriptionDAMMAM PHARMAValid

67 more — full table

Indications — CHI Daman Drug Formulary

ACUTE BIPOLAR I DEPRESSION; ACUTE MANIA; ALZHEIMER / DEMENTIA; ANXIETY DISORDERS; ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD); AUTISM SPECTRUM DISORDER; BIPOLAR I DISORDER MAINTENANCE; BIPOLAR II DISORDER; DEPRESSION; MENSTRUAL DISORDERS; SCHIZOPHRENIA; TOURETTE SYNDROME

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

ProductStrengthForm · routeApplicantStatusFirst approved
SEROQUELEQ 25MG BASE; EQ 100MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASE; EQ 50MG BASEtablet · oralCHEPLAPHARMPrescription26 Sep 1997
SEROQUEL XREQ 50MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASE; EQ 150MG BASEtablet, extended release · oralCHEPLAPHARMPrescription17 May 2007
SEROQUEL XR50MG; 200MG; 300MG; 400MGtablet, extended release · oralCHEPLAPHARM ARZNEIMITTEL GMBHPrescription15 Nov 2007
QUETIAPINE FUMARATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE; EQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet · oralRISINGPrescription27 Mar 2012
QUETIAPINE FUMARATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE; EQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet · oralTEVA PHARMSPrescription27 Mar 2012
QUETIAPINE FUMARATEEQ 25MG BASEtablet · oralHIKMA PHARMSPrescription27 Mar 2012
QUETIAPINE FUMARATEEQ 50MG BASE; EQ 100MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet · oralHIKMA PHARMSPrescription27 Mar 2012
QUETIAPINE FUMARATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet · oralSCIEGEN PHARMSPrescription27 Mar 2012
QUETIAPINE FUMARATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE; EQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet · oralAUROBINDO PHARMA LTDPrescription27 Mar 2012
QUETIAPINE FUMARATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet · oralLUPIN LTDPrescription27 Mar 2012
QUETIAPINE FUMARATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet · oralACCORD HLTHCAREPrescription27 Mar 2012
QUETIAPINE FUMARATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE; EQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet · oralALKEM LABS LTDPrescription12 Feb 2013
QUETIAPINE FUMARATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet · oralUNICHEMPrescription8 Mar 2016
QUETIAPINE FUMARATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet · oralMACLEODS PHARMSPrescription17 May 2016
QUETIAPINE FUMARATEEQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet, extended release · oralACCORD HLTHCAREPrescription1 Nov 2016
QUETIAPINE FUMARATEEQ 50MG BASE; EQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet, extended release · oralPLATINUMPrescription9 May 2017
QUETIAPINE FUMARATEEQ 50MG BASE; EQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet, extended release · oralLUPINPrescription17 May 2017
QUETIAPINE FUMARATEEQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet, extended release · oralMACLEODS PHARMSPrescription29 Nov 2017
QUETIAPINE FUMARATEEQ 50MG BASEtablet, extended release · oralACCORD HLTHCAREPrescription29 Nov 2017
QUETIAPINE FUMARATEEQ 50MG BASE; EQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet, extended release · oralAUROBINDO PHARMAPrescription29 Nov 2017
QUETIAPINE FUMARATEEQ 50MG BASE; EQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet, extended release · oralNOVAST LABSPrescription29 Nov 2017
QUETIAPINE FUMARATEEQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASE; EQ 50MG BASEtablet, extended release · oralSCIEGEN PHARMSPrescription29 Nov 2017
QUETIAPINE FUMARATEEQ 150MG BASE; EQ 200MG BASEtablet, extended release · oralALIGNSCIENCE PHARMAPrescription28 Sep 2018
QUETIAPINE FUMARATEEQ 50MG BASE; EQ 150MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet, extended release · oralPRINSTON INCPrescription26 Apr 2022
QUETIAPINE FUMARATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE; EQ 200MG BASE; EQ 300MG BASE; EQ 400MG BASEtablet · oralHETERO LABS LTD VPrescription16 Jun 2022

17 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ACH-QUETIAPINE0238779425 MGTABLET (IMMEDIATE-RELEASE) · ORALACCORD HEALTHCARE INC
ACH-QUETIAPINE02387808100 MGTABLET (IMMEDIATE-RELEASE) · ORALACCORD HEALTHCARE INC
ACH-QUETIAPINE02387816150 MGTABLET (IMMEDIATE-RELEASE) · ORALACCORD HEALTHCARE INC
ACH-QUETIAPINE02387824200 MGTABLET (IMMEDIATE-RELEASE) · ORALACCORD HEALTHCARE INC
ACH-QUETIAPINE02387832300 MGTABLET (IMMEDIATE-RELEASE) · ORALACCORD HEALTHCARE INC
ACH-QUETIAPINE FUMARATE XR0245086050 MGTABLET (EXTENDED-RELEASE) · ORALACCORD HEALTHCARE INC
ACH-QUETIAPINE FUMARATE XR02450879150 MGTABLET (EXTENDED-RELEASE) · ORALACCORD HEALTHCARE INC
ACH-QUETIAPINE FUMARATE XR02450887200 MGTABLET (EXTENDED-RELEASE) · ORALACCORD HEALTHCARE INC
ACH-QUETIAPINE FUMARATE XR02450895300 MGTABLET (EXTENDED-RELEASE) · ORALACCORD HEALTHCARE INC
ACH-QUETIAPINE FUMARATE XR02450909400 MGTABLET (EXTENDED-RELEASE) · ORALACCORD HEALTHCARE INC
ACT QUETIAPINE0231608025 MGTABLET · ORALTEVA CANADA LIMITED
ACT QUETIAPINE02316099100 MGTABLET · ORALTEVA CANADA LIMITED
ACT QUETIAPINE02316110200 MGTABLET · ORALTEVA CANADA LIMITED
ACT QUETIAPINE02316129300 MGTABLET · ORALTEVA CANADA LIMITED
AG-QUETIAPINE FUMARATE0251693425 MGTABLET (IMMEDIATE-RELEASE) · ORALANGITA PHARMA INC.
AG-QUETIAPINE FUMARATE02516942100 MGTABLET (IMMEDIATE-RELEASE) · ORALANGITA PHARMA INC.
AG-QUETIAPINE FUMARATE02516950200 MGTABLET (IMMEDIATE-RELEASE) · ORALANGITA PHARMA INC.
AG-QUETIAPINE FUMARATE02516969300 MGTABLET (IMMEDIATE-RELEASE) · ORALANGITA PHARMA INC.
APO-QUETIAPINE FUMARATE02501643100 MGTABLET (IMMEDIATE-RELEASE) · ORALAPOTEX INC
APO-QUETIAPINE XR02457245200 MGTABLET (EXTENDED-RELEASE) · ORALAPOTEX INC
APO-QUETIAPINE XR02457253300 MGTABLET (EXTENDED-RELEASE) · ORALAPOTEX INC
AURO-QUETIAPINE0239020525 MGTABLET · ORALAURO PHARMA INC
AURO-QUETIAPINE02390213100 MGTABLET · ORALAURO PHARMA INC
AURO-QUETIAPINE02390248200 MGTABLET · ORALAURO PHARMA INC
AURO-QUETIAPINE02390256300 MGTABLET · ORALAURO PHARMA INC

68 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACQUETIAPINE 150 MG TABLET$1.23864per EA23 Sep 2026
US NADACQUETIAPINE ER 150 MG TABLET$0.18361per EA23 Sep 2026
US NADACQUETIAPINE ER 200 MG TABLET$0.21991per EA23 Sep 2026
US NADACQUETIAPINE ER 300 MG TABLET$0.27174per EA23 Sep 2026
US NADACQUETIAPINE ER 400 MG TABLET$0.31743per EA23 Sep 2026
US NADACQUETIAPINE ER 50 MG TABLET$0.11917per EA23 Sep 2026
US NADACQUETIAPINE FUMARATE 100 MG TAB$0.0483per EA23 Sep 2026
US NADACQUETIAPINE FUMARATE 200 MG TAB$0.08962per EA23 Sep 2026
US NADACQUETIAPINE FUMARATE 25 MG TAB$0.02147per EA23 Sep 2026
US NADACQUETIAPINE FUMARATE 300 MG TAB$0.12747per EA23 Sep 2026
US NADACQUETIAPINE FUMARATE 400 MG TAB$0.16163per EA23 Sep 2026
US NADACQUETIAPINE FUMARATE 50 MG TAB$0.02817per EA23 Sep 2026
NHS Drug TariffQuetiapine 100mg tablets£2.1360 tablet1 Oct 2026
NHS Drug TariffQuetiapine 150mg modified-release tablets£113.1060 tablet1 Oct 2026
NHS Drug TariffQuetiapine 150mg tablets£2.3660 tablet1 Oct 2026
NHS Drug TariffQuetiapine 200mg modified-release tablets£113.1060 tablet1 Oct 2026
NHS Drug TariffQuetiapine 200mg tablets£2.7060 tablet1 Oct 2026
NHS Drug TariffQuetiapine 20mg/ml oral suspension sugar free£223.18150 ml1 Oct 2026
NHS Drug TariffQuetiapine 25mg tablets£1.0560 tablet1 Oct 2026
NHS Drug TariffQuetiapine 300mg modified-release tablets£170.0060 tablet1 Oct 2026
NHS Drug TariffQuetiapine 300mg tablets£3.1760 tablet1 Oct 2026
NHS Drug TariffQuetiapine 400mg modified-release tablets£226.2060 tablet1 Oct 2026
NHS Drug TariffQuetiapine 400mg tablets£25.0060 tablet1 Oct 2026
NHS Drug TariffQuetiapine 50mg modified-release tablets£67.6660 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)

  • 24.1. Medicines for psychotic disorders · core
    Therapeutic equivalent to risperidone for Schizophrenia or other primary psychotic disorders
  • 24.2.2. Medicines for bipolar disorders · core
    Bipolar or related disorders
    Oral > Solid > tablet: 25 mg (immediate-release); 100 mg (immediate-release); 150 mg (immediate-release); 200 mg (immediate-release); 300 mg (immediate-release); 50 mg (modified-release); 150 mg (modified-release); 200 mg (modified-release); 300 mg (modified-release); 400 mg (modified-release)

Safety signals and safety-related labeling changes

All safety entries for quetiapine →

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.