Regulatory PathRegulatory requirements compared

Active substance

Warfarin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
COUFATEX 1 mg Tablet1 mgTablet · Oral use100 BottleSAR 77.70Generic · PrescriptionAPOTEX INC. (SIGNET SITE)Valid
COUFATEX 2 mg Tablet2 mgTablet · Oral use100 BottleSAR 82.80Generic · PrescriptionAPOTEX INC. (SIGNET SITE)Valid
COUFATEX 5 mg Tablet5 mgTablet · Oral use100 BottleSAR 65.50Generic · PrescriptionAPOTEX INC. (SIGNET SITE)Valid
Coufatex2.5 mgTablet · Oral use100 BottleSAR 68.85Generic · PrescriptionAPOTEX INC. (SIGNET SITE)Valid
Coufatex3 mgTablet · Oral use100 BottleSAR 97.40Generic · PrescriptionAPOTEXValid
Coufatex4 mgTablet · Oral use100 BottleSAR 97.40Generic · PrescriptionAPOTEXValid
Coufatex10 mgTablet · Oral use100 BottleSAR 113.05Generic · PrescriptionAPOTEXValid
Solfarin1 mg/mlOral suspension · Oral use1 BottleSAR 815.00NCE · PrescriptionRosemont Pharmaceuticals LtdValid
Warfarin Macleods5 mgTablet · Oral use100 BottleSAR 62.20Generic · PrescriptionMacleods Pharmaceuticals Ltd.Valid
Warfarin ZYD1 mgTablet · Oral use100 BottleSAR 73.80Generic · PrescriptionZydus Lifesciences LimitedValid
Warfarin ZYD2 mgTablet · Oral use100 BottleSAR 78.65Generic · PrescriptionZydus Lifesciences LimitedValid
Warfarin ZYD2.5 mgTablet · Oral use100 BottleSAR 65.40Generic · PrescriptionZydus Lifesciences LimitedValid
Warfarin ZYD3 mgTablet · Oral use100 BottleSAR 92.55Generic · PrescriptionZydus Lifesciences LimitedValid
Warfarin ZYD5 mgTablet · Oral use100 BottleSAR 62.20Generic · PrescriptionZydus Lifesciences LimitedValid
Warfarin ZYD10 mgTablet · Oral use100 BottleSAR 107.40Generic · PrescriptionZydus Lifesciences LimitedValid
COUMADIN7.5 mgTablet · Oral use100 BlisterSAR 131.80NCE · PrescriptionBRISTOL-MYERS SQUIBBWithdrawn by MAH · Not Marketed
COUMADIN2.5 mgTablet · Oral use100 BlisterSAR 142.30NCE · PrescriptionBRISTOL-MYERS SQUIBBWithdrawn by MAH · Not Marketed
COUMADIN2.5 mgTablet · Oral use100 BlisterSAR 105.65NCE · PrescriptionBRISTOL-MYERS SQUIBBWithdrawn by MAH · Not Marketed
COUMADIN2 mgTablet · Oral use100 BlisterSAR 99.60NCE · PrescriptionBRISTOL-MYERS SQUIBBWithdrawn by MAH · Not Marketed
COUMADIN5 mgTablet · Oral use100 BlisterSAR 114.75NCE · PrescriptionBRISTOL-MYERS SQUIBBWithdrawn by MAH · Not Marketed
COUMADIN5 mgTablet · Oral use100 BlisterSAR 99.60NCE · PrescriptionBRISTOL-MYERS SQUIBBWithdrawn by MAH · Not Marketed
COUMADIN2 mgTablet · Oral use100 BlisterSAR 109.55NCE · PrescriptionBRISTOL-MYERS SQUIBBWithdrawn by MAH · Not Marketed
COUMADIN10 mgTablet · Oral use100 BlisterSAR 118.60NCE · PrescriptionBRISTOL-MYERS SQUIBBWithdrawn by MAH · Not Marketed
WARFARIN SODIUM 1MG TAB1 mgTablet · Oral use28 BlisterSAR 11.40Generic · PrescriptionIVAX PHARMACEUTICALSWithdrawn by MAH · Not Marketed
WARFARIN SODIUM 3MG TAB3 mgTablet · Oral use28 BlisterSAR 15.75Generic · PrescriptionIVAX PHARMACEUTICALSWithdrawn by MAH · Not Marketed

1 more — full table

Indications — CHI Daman Drug Formulary

ANTIPHOSPHOLIPID SYNDROME; ATRIAL FIBRILLATION; CARDIOMYOPATHY; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; HIP AND KNEE REPLACEMENT SURGERY; HODGKIN'S LYMPHOMA; ISCHEMIC STROKE; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; MULTIPLE MYELOMA; MYELOFIBROSIS-ADVERSE REACTION MANAGEMENT; POLYCYTHEMIA VERA - THROMBOSIS; PORTAL VEIN THROMBOSIS; PULMONARY ARTERIAL HYPERTENSION; PULMONARY EMBOLISM; T-CELL LYMPHOMA-RENAL TOXICITY; VENOUS THROMBOEMBOLISM DISEASE (VTE)-TREATMENT

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

ProductStrengthForm · routeApplicantStatusFirst approved
WARFARIN SODIUM10MG; 1MG; 2MG; 2.5MG; 3MG; 4MG; 5MG; 6MG; 7.5MGtablet · oralTAROPrescription15 Jul 1999
JANTOVEN1MG; 2MG; 2.5MG; 3MG; 4MG; 5MG; 6MG; 7.5MG; 10MGtablet · oralUPSHER SMITH LABSPrescription2 Oct 2003
WARFARIN SODIUM1MG; 2MG; 2.5MG; 3MG; 4MG; 5MG; 6MG; 7.5MG; 10MGtablet · oralZYDUS PHARMS USAPrescription30 May 2006
WARFARIN SODIUM2MG; 2.5MG; 3MG; 4MG; 5MG; 6MG; 7.5MG; 10MG; 1MGtablet · oralPLIVAPrescription5 Jul 2006
WARFARIN SODIUM1MG; 2MG; 2.5MG; 3MG; 4MG; 5MG; 6MG; 7.5MG; 10MGtablet · oralINVAGEN PHARMSPrescription25 May 2011
WARFARIN SODIUM1MG; 2MG; 2.5MG; 3MG; 4MG; 5MG; 6MG; 7.5MG; 10MGtablet · oralAMNEAL PHARMSPrescription4 Mar 2013
COUMADIN10MG; 5MG; 2MG; 7.5MG; 2.5MG; 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 4MG; 3MG; 6MGtablet · oralBRISTOL MYERS SQUIBBDiscontinued8 Jun 1954
COUMADIN75MG/VIAL; 50MG/VIAL; 5MG/VIALinjectable · injectionBRISTOL MYERS SQUIBBDiscontinued8 Jun 1954
PANWARFIN2MG; 2.5MG; 5MG; 7.5MG; 10MGtablet · oralABBOTTDiscontinued11 Aug 1972
WARFARIN SODIUM1MG; 2MG; 2.5MG; 4MG; 5MG; 7.5MG; 10MG; 3MG; 6MGtablet · oralBARRDiscontinued26 Mar 1997
WARFARIN SODIUM1MG; 2MG; 2.5MG; 4MG; 5MG; 7.5MG; 10MG; 3MG; 6MGtablet · oralCHARTWELL RXDiscontinued30 Sep 1997
WARFARIN SODIUM1MG; 2MG; 2.5MG; 3MG; 4MG; 5MG; 6MG; 7.5MG; 10MGtablet · oralAUROBINDO PHARMA USADiscontinued27 Sep 2004
WARFARIN SODIUM1MG; 2MG; 2.5MG; 3MG; 4MG; 5MG; 6MG; 7.5MG; 10MGtablet · oralAIPING PHARM INCDiscontinued27 Jun 2013
WARFARIN SODIUM7.5MGtablet · oralWATSON LABSDiscontinued
WARFARIN SODIUM5MGtablet · oralWATSON LABSDiscontinued
WARFARIN SODIUM2.5MGtablet · oralWATSON LABSDiscontinued
WARFARIN SODIUM10MGtablet · oralWATSON LABSDiscontinued
WARFARIN SODIUM2MGtablet · oralWATSON LABSDiscontinued
WARFARIN SODIUM2MGtablet · oralUSL PHARMADiscontinued
WARFARIN SODIUM2.5MGtablet · oralUSL PHARMADiscontinued
WARFARIN SODIUM5MGtablet · oralUSL PHARMADiscontinued
ATHROMBIN25MG; 10MG; 5MGtablet · oralPHARM RES ASSOCDiscontinued
ATHROMBIN-K5MG; 10MG; 25MG; 2MGtablet · oralPHARM RES ASSOCDiscontinued

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-WARFARIN022429241 MGTABLET · ORALAPOTEX INC
APO-WARFARIN022429252 MGTABLET · ORALAPOTEX INC
APO-WARFARIN022429262.5 MGTABLET · ORALAPOTEX INC
APO-WARFARIN022429274 MGTABLET · ORALAPOTEX INC
APO-WARFARIN022429285 MGTABLET · ORALAPOTEX INC
APO-WARFARIN0224292910 MGTABLET · ORALAPOTEX INC
APO-WARFARIN022456183 MGTABLET · ORALAPOTEX INC
TARO-WARFARIN022426801 MGTABLET · ORALTARO PHARMACEUTICALS INC
TARO-WARFARIN022426812 MGTABLET · ORALTARO PHARMACEUTICALS INC
TARO-WARFARIN022426822.5 MGTABLET · ORALTARO PHARMACEUTICALS INC
TARO-WARFARIN022426833 MGTABLET · ORALTARO PHARMACEUTICALS INC
TARO-WARFARIN022426844 MGTABLET · ORALTARO PHARMACEUTICALS INC
TARO-WARFARIN022426855 MGTABLET · ORALTARO PHARMACEUTICALS INC
TARO-WARFARIN022426866 MGTABLET · ORALTARO PHARMACEUTICALS INC
TARO-WARFARIN0224268710 MGTABLET · ORALTARO PHARMACEUTICALS INC
TARO-WARFARIN022426977.5 MGTABLET · ORALTARO PHARMACEUTICALS INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACJANTOVEN 1 MG TABLET$0.09856per EA23 Sep 2026
US NADACJANTOVEN 10 MG TABLET$0.10627per EA23 Sep 2026
US NADACJANTOVEN 2 MG TABLET$0.09296per EA23 Sep 2026
US NADACJANTOVEN 2.5 MG TABLET$0.09608per EA23 Sep 2026
US NADACJANTOVEN 3 MG TABLET$0.09864per EA23 Sep 2026
US NADACJANTOVEN 4 MG TABLET$0.09565per EA23 Sep 2026
US NADACJANTOVEN 5 MG TABLET$0.08882per EA23 Sep 2026
US NADACJANTOVEN 6 MG TABLET$0.09814per EA23 Sep 2026
US NADACJANTOVEN 7.5 MG TABLET$0.08912per EA23 Sep 2026
US NADACWARFARIN SODIUM 1 MG TABLET$0.09856per EA23 Sep 2026
US NADACWARFARIN SODIUM 10 MG TABLET$0.10627per EA23 Sep 2026
US NADACWARFARIN SODIUM 2 MG TABLET$0.09296per EA23 Sep 2026
NHS Drug TariffWarfarin 1mg tablets£1.0628 tablet1 Oct 2026
NHS Drug TariffWarfarin 1mg/ml oral suspension sugar free£209.72150 ml1 Oct 2026
NHS Drug TariffWarfarin 3mg tablets£0.8628 tablet1 Oct 2026
NHS Drug TariffWarfarin 500microgram tablets£1.4328 tablet1 Oct 2026
NHS Drug TariffWarfarin 5mg tablets£0.8628 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)

  • 10.2. Medicines affecting coagulation · core (EML); complementary (EMLc)
    Venous thromboembolism; Cerebral ischaemic stroke due to embolic occlusion; Atrial fibrillation; Other specified diseases of arteries or arterioles
    Oral > Solid > tablet: 5 mg (scored) (sodium); 1 mg (scored) (sodium); 2 mg (scored) (sodium); 0.5 mg (scored) (sodium) (EMLc); 3 mg (scored) (sodium)

Safety signals and safety-related labeling changes

All safety entries for warfarin →

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.