Regulatory PathRegulatory requirements compared

Active substance

Quinine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
QUININE SULFATE324MGcapsule · oralTEVA PHARMSPrescription28 Sep 2012
QUININE SULFATE324MGcapsule · oralLUPINPrescription24 Apr 2015
QUININE SULFATE324MGcapsule · oralAMNEAL PHARMSPrescription15 Jul 2015
QUININE SULFATE324MGcapsule · oralINGENUS PHARMS LLCPrescription22 Jul 2015
QUALAQUIN324MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralSUN PHARM INDUSTRIESDiscontinued12 Aug 2005
QUININE SULFATE324MGcapsule · oralAUROBINDO PHARMA USADiscontinued14 Dec 2012

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
PRO-QUININE - 20002311216200 MGCAPSULE · ORALPRO DOC LIMITEE
PRO-QUININE - 30002311224300 MGCAPSULE · ORALPRO DOC LIMITEE
TEVA-QUININE00021008200 MGCAPSULE · ORALTEVA CANADA LIMITED
TEVA-QUININE00021016300 MGCAPSULE · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACQUININE SULFATE 324 MG CAPSULE$0.69802per EA23 Sep 2026
NHS Drug TariffQuinine bisulfate 300mg tablets£2.9428 tablet1 Oct 2026
NHS Drug TariffQuinine sulfate 200mg tablets£2.0728 tablet1 Oct 2026
NHS Drug TariffQuinine sulfate 300mg tablets£2.8328 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)

  • 6.5.3.1. Antimalarial medicines > Medicines for curative treatment · core
    Malaria due to Plasmodium falciparum
    Parenteral > General injections > IV: 300 mg per mL in 2 mL ampoule (hydrochloride) solution for infusion; 60 mg per mL in 2 mL ampoule (hydrochloride) solution for infusion (EMLc)

Safety signals and safety-related labeling changes

All safety entries for quinine →

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.