Regulatory PathRegulatory requirements compared

Active substance

Nystatin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
MIKOSTAT 100000 U OINTMENT100000 IU/gOintment · Topical1 TubeSAR 10.00Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
MIKOSTAT 100000U CREAM100000 IUCream · Topical1 TubeSAR 7.50Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
MIKOSTAT 100000U\ML ORAL SUSP100000 IU/mlOral suspension · Oral use1 BottleSAR 9.15Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
MYCOSAT 100,000IU\ML ORAL SUSP100000 IU/mlSuspension · Oral use1 BottleSAR 7.40Generic · PrescriptionAmman Pharmaceutical Industries (API)Valid
RIANEST100000 IUCream · Topical1 TubeSAR 7.50Generic · PrescriptionRIYADH PHARMAValid
RIANEST100000 IUOintment · Topical1 TubeSAR 10.00Generic · PrescriptionRIYADH PHARMAValid
RIANEST100000 IUOral suspension · Oral use1 BottleSAR 9.15Generic · PrescriptionRIYADH PHARMAValid
SINATEN 100000 I.U VAGINAL TAB.100000 IUVaginal tablet · Vaginal use16 BlisterSAR 28.00Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
DERMOSE CUSI NYSTATIN OIN.100000 I.U100000 IUOintment · Topical1 TubeSAR 6.40NCE · PrescriptionALCON CUSIWithdrawn by MAH · Not Marketed
MYCOSTATIN 100000 UNITS-ML ORAL SUSP100000 IU/mlOral suspension · Oral use1 BottleSAR 26.65NCE · PrescriptionBRISTOL-MYERS SQUIBBWithdrawn by MAH · Not Marketed
SINATEN 10 000 IU OINTMENT 15 GM100000 IUOintment · Topical1 TubeSAR 4.65Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyWithdrawn by MAH · Not Marketed
SINATEN 500000 IU \5ML ORAL SUSP100000 IU/mlOral suspension · Oral use1 BottleSAR 7.40Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

FUNGAL INFECTIONS OF THE GENITAL TRACT - CANDIDIASIS OF OTHER UROGENITAL SITES

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

ProductStrengthForm · routeApplicantStatusFirst approved
NILSTAT100,000 UNITS/MLsuspension · oralCHARTWELL MOLECULESPrescription14 Apr 1971
NYSTATIN100,000 UNITS/GMcream · topicalCOSETTE PHARMS NCPrescription25 May 1976
NYSTATIN100,000 UNITS/GMcream · topicalFOUGERA PHARMSPrescription1 Feb 1979
NYSTATIN100,000 UNITS/GMcream · topicalPADAGIS USPrescription11 Dec 1979
NYSTATIN100,000 UNITS/GMointment · topicalFOUGERA PHARMSPrescription23 Sep 1982
NYSTATIN500,000 UNITStablet · oralHERITAGEPrescription22 Dec 1983
NYSTATIN500,000 UNITStablet · oralTEVAPrescription16 Jan 1984
NYSTATIN100,000 UNITS/GMointment · topicalPADAGIS USPrescription13 Feb 1984
NYSTATIN100,000 UNITS/MLsuspension · oralFOUGERA PHARMS INCPrescription7 Jun 1984
NYSTATIN100,000 UNITS/MLsuspension · oralPHARMOBEDIENTPrescription29 Oct 1984
NYSTATIN100,000 UNITS/GMointment · topicalACTAVIS MID ATLANTICPrescription13 Nov 1987
NYSTATIN100,000 UNITS/GMcream · topicalACTAVIS MID ATLANTICPrescription13 Jun 1988
NYSTATIN100,000 UNITS/MLsuspension · oralSCIEGEN PHARMSPrescription27 Dec 1991
NYSTATIN100,000 UNITS/GMcream · topicalSUN PHARMA CANADAPrescription29 Jan 1993
NYSTOP100,000 UNITS/GMpowder · topicalPADAGIS USPrescription16 Aug 1996
NYSTATIN100,000 UNITS/GMpowder · topicalDR REDDYS LABS SAPrescription15 Jul 2004
NYSTATIN100,000 UNITS/GMpowder · topicalLUPINPrescription23 Jul 2004
NYSTATIN100,000 UNITS/GMpowder · topicalUPSHER SMITH LABSPrescription3 May 2005
NYSTATIN100,000 UNITS/MLsuspension · oralGENUSPrescription28 Jun 2005
NYSTATIN100,000 UNITS/MLsuspension · oralPHARM ASSOCPrescription7 Jan 2016
NYSTATIN100,000 UNITS/GMpowder · topicalLYNEPrescription30 May 2017
NYSTATIN100,000 UNITS/GMpowder · topicalZYDUS PHARMSPrescription8 Jun 2017
NYSTATIN100,000 UNITS/GMcream · topicalCROWN LABS INCPrescription26 Sep 2017
NYSTATIN100,000 UNITS/GMointment · topicalCOSETTEPrescription6 Oct 2017
KLAYESTA100,000 UNITS/GMpowder · topicalEPIC PHARMA LLCPrescription30 Apr 2018

56 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
JAMP-NYSTATIN ORAL SUSPENSION USP02433443100000 UNIT / MLSUSPENSION · ORALJAMP PHARMA CORPORATION
NYADERM00716871100000 UNIT / GCREAM · TOPICALTARO PHARMACEUTICALS INC
NYADERM0071690125000 UNIT / GCREAM · VAGINALTAROPHARMA, A DIVISION OF TARO PHARMACEUTICALS INC.
PMS-NYSTATIN SUSPENSION 100000 UNIT/ML00792667100000 UNIT / MLSUSPENSION · ORALPHARMASCIENCE INC
TEVA-NYSTATIN02194201100000 UNIT / MLSUSPENSION · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACKLAYESTA 100,000 UNIT/GM POWD$0.42143per GM23 Sep 2026
US NADACKLAYESTA 100,000 UNIT/GM POWD$0.31335per GM23 Sep 2026
US NADACKLAYESTA 100,000 UNIT/GM POWD$0.25738per GM23 Sep 2026
US NADACNYSTATIN 100,000 UNIT/GM CREAM$0.19826per GM23 Sep 2026
US NADACNYSTATIN 100,000 UNIT/GM CREAM$0.15101per GM23 Sep 2026
US NADACNYSTATIN 100,000 UNIT/GM OINT$0.23306per GM23 Sep 2026
US NADACNYSTATIN 100,000 UNIT/GM OINT$0.23754per GM23 Sep 2026
US NADACNYSTATIN 100,000 UNIT/GM POWD$0.42143per GM23 Sep 2026
US NADACNYSTATIN 100,000 UNIT/GM POWD$0.31335per GM23 Sep 2026
US NADACNYSTATIN 100,000 UNIT/GM POWD$0.25738per GM23 Sep 2026
US NADACNYSTATIN 100,000 UNIT/ML SUSP$0.13995per ML23 Sep 2026
US NADACNYSTATIN 100,000 UNIT/ML SUSP$0.05693per ML30 Sep 2026
NHS Drug TariffNystatin 100,000units/ml oral suspension£9.7530 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.

WHO WHO Model List of Essential Medicines (2025)

  • 6.3. Antifungal medicines · core
    Candidosis
    Oral > Liquid: 100000 IU per mL (EMLc) | Local > Topical > Other: 100000 IU pessary (EML) | Oral > Solid > dosage form: 500000 IU | Oral > Solid > lozenge: 100000 IU

Combinations containing Nystatin

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.