Regulatory PathRegulatory requirements compared

Active substance

Hydroxychloroquine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ARTHOSAVE 200 mg tablet200 mgTablet · Oral use100 BottleSAR 127.00Generic · PrescriptionAPOTEXValid
Hydroxychloroquine SAJA200 mgFilm-coated tablet · Oral use60 BlisterSAR 71.80Generic · PrescriptionSAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL COValid
Hydroxychloroquine Sulfate200 mgTablet · Oral use100 BlisterSAR 109.10Generic · PrescriptionQomel CoValid
PLAQUENIL 200MG TAB200 mgFilm-coated tablet · Oral use60 BlisterSAR 84.45NCE · PrescriptionSanofi-aventis Ireland LimitedValid
Quenfil200 mgFilm-coated tablet · Oral use60 BlisterSAR 65.45Generic · PrescriptionMiddle East Pharmaceutical Industries Co Ltd Avalon PharmaValid
Vasrasti200 mgFilm-coated tablet · Oral use60 BlisterSAR 76.05Generic · PrescriptionALPHA PHARMA INDUSTRYValid
PLAQUENIL 200MG TAB200 mgFilm-coated tablet · Oral use60 BlisterSAR 93.80NCE · PrescriptionAVENTIS PHARMA LIMITEDWithdrawn by MAH · Not Marketed
PLAQUENIL 200MG TAB200 mgFilm-coated tablet · Oral use60 BlisterSAR 117.25NCE · PrescriptionSANOFI-SYNTHLABOWithdrawn by MAH · Not Marketed
RESOCHIN AMP 250MG-5ML50 mg/mlInjection · Intravenous use5 AmpouleSAR 18.65NCE · PrescriptionBAYER PHARMA AGWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ANTIPHOSPHOLIPID SYNDROME; GRAFT VERSUS HOST DISEASE; JUVENILE IDIOPATHIC ARTHRITIS (JIA); LICHEN PLANUS; MYOSITIS; RHEUMATOID ARITHRITIS; SARCOIDOSIS; SJOGREN'S SYNDROME; SYSTEMIC LUPUS ERYTHEMATOSUS

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

ProductStrengthForm · routeApplicantStatusFirst approved
PLAQUENIL200MGtablet · oralADVANZ PHARMAPrescription18 Apr 1955
HYDROXYCHLOROQUINE SULFATE200MGtablet · oralTEVA PHARMSPrescription30 Sep 1994
HYDROXYCHLOROQUINE SULFATE200MGtablet · oralSANDOZPrescription30 Nov 1995
HYDROXYCHLOROQUINE SULFATE200MGtablet · oralCREEKWOOD PHARMSPrescription27 Jan 1996
HYDROXYCHLOROQUINE SULFATE200MGtablet · oralAUROBINDO PHARMA USAPrescription29 May 1998
HYDROXYCHLOROQUINE SULFATE200MGtablet · oralIPCA LABS LTDPrescription14 Jun 2007
HYDROXYCHLOROQUINE SULFATE200MGtablet · oralZYDUS PHARMS USA INCPrescription21 Sep 2007
HYDROXYCHLOROQUINE SULFATE200MG; 100MG; 300MG; 400MGtablet · oralAPPCOPrescription1 May 2018
HYDROXYCHLOROQUINE SULFATE200MGtablet · oralALKALOIDA ZRTPrescription8 May 2018
HYDROXYCHLOROQUINE SULFATE200MGtablet · oralAMNEAL PHARMS COPrescription15 May 2018
HYDROXYCHLOROQUINE SULFATE200MGtablet · oralCHARTWELL RXPrescription6 Jul 2018
HYDROXYCHLOROQUINE SULFATE200MGtablet · oralLAURUSPrescription15 Jan 2019
HYDROXYCHLOROQUINE SULFATE200MG; 100MG; 300MG; 400MGtablet · oralACCORD HLTHCAREPrescription7 Apr 2020
HYDROXYCHLOROQUINE SULFATE200MGtablet · oralSENORES PHARMSPrescription14 May 2020
SOVUNA200MG; 300MGtablet · oralNOVITIUM PHARMAPrescription14 Jan 2022
HYDROXYCHLOROQUINE SULFATE200MGtablet · oralWATSON LABSDiscontinued30 Nov 1995
HYDROXYCHLOROQUINE SULFATE200MGtablet · oralHIKMA PHARMSDiscontinued15 Aug 2007

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-HYDROXYQUINE02246691200 MGTABLET · ORALAPOTEX INC
HYDROXYCHLOROQUINE02519348200 MGTABLET · ORALSANIS HEALTH INC
JAMP HYDROXYCHLOROQUINE SULFATE02491427200 MGTABLET · ORALJAMP PHARMA CORPORATION
MINT-HYDROXYCHLOROQUINE02424991200 MGTABLET · ORALMINT PHARMACEUTICALS INC
NRA-HYDROXYCHLOROQUINE02511886200 MGTABLET · ORALNORA PHARMA INC
PLAQUENIL02017709200 MGTABLET · ORALSANOFI-AVENTIS CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACHYDROXYCHLOROQUINE 100 MG TAB$0.18906per EA23 Sep 2026
US NADACHYDROXYCHLOROQUINE 200 MG TAB$0.14901per EA23 Sep 2026
US NADACHYDROXYCHLOROQUINE 300 MG TAB$0.53021per EA23 Sep 2026
US NADACHYDROXYCHLOROQUINE 400 MG TAB$0.66981per EA23 Sep 2026
NHS Drug TariffHydroxychloroquine 200mg tablets£3.9360 tablet1 Oct 2026
NHS Drug TariffHydroxychloroquine 300mg tablets£25.6430 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)

  • 29.2. Disease-modifying anti-rheumatic drugs (DMARDs) · complementary
    Systemic lupus erythematosus; Cutaneous lupus erythematosus of unspecified type
    Oral > Solid: 200 mg (as sulfate)

Safety signals and safety-related labeling changes

All safety entries for hydroxychloroquine →

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.