Regulatory PathRegulatory requirements compared

Active substances

Dapagliflozin + Metformin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Dezeroga-Met5,1000 mg,mgProlonged-release film-coated tablet · Oral use56 BlisterSAR 110.90Generic · PrescriptionMed City PharmaValid
Dezeroga-Met10,1000 mg,mgProlonged-release film-coated tablet · Oral use28 BlisterSAR 107.80Generic · PrescriptionMed City PharmaValid
Divinusmet1000,5 mg,mgFilm-coated tablet · Oral use60 BottleSAR 119.40Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
Divinusmet1000,10 mg,mgFilm-coated tablet · Oral use30 BottleSAR 116.10Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
Volzamet XR5/1000 mgFilm-coated tablet · Oral use60 BlisterSAR 109.70Generic · PrescriptionCooper Pharma ArabiaValid
Volzamet XR10/1000 mgFilm-coated tablet · Oral use30 BlisterSAR 106.60Generic · PrescriptionCooper Pharma ArabiaValid
XIGDUO XR 10 mg/1000 mg Film Coted Tablet1000,10 mg,mgFilm-coated tablet · Oral use28 BlisterSAR 124.40NCE · PrescriptionAstraZeneca ABValid
XIGDUO XR 10 mg/500 mg Film Coted Tablet500,10 mg,mgFilm-coated tablet · Oral use28 BlisterSAR 122.45NCE · PrescriptionAstraZeneca ABValid
XIGDUO XR 5 mg/1000 mg Film Coted Tablet1000,5 mg,mgFilm-coated tablet · Oral use56 BlisterSAR 128.00NCE · PrescriptionAstraZeneca ABValid
XIGDUO XR 5 mg/500 mg Film Coted Tablet500,5 mg,mgFilm-coated tablet · Oral use28 BlisterSAR 108.40NCE · PrescriptionAstraZeneca ABWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 2

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

ProductStrengthForm · routeApplicantStatusFirst approved
XIGDUO XR5MG;500MG; 5MG;1GM; 10MG;500MG; 10MG;1GM; 2.5MG;1GMtablet, extended release · oralASTRAZENECA ABPrescription29 Oct 2014
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;500MG; 5MG;1GM; 10MG;500MG; 10MG;1GMtablet, extended release · oralMICRO LABSPrescription6 Apr 2026
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;500MG; 5MG;1GM; 10MG;500MG; 10MG;1GMtablet, extended release · oralMSNPrescription6 Apr 2026
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;500MG; 5MG;1GM; 10MG;500MG; 10MG;1GMtablet, extended release · oralAUROBINDO PHARMAPrescription6 Apr 2026
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;1GM; 10MG;500MG; 10MG;1GMtablet, extended release · oralSUN PHARMPrescription6 Apr 2026
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;500MG; 10MG;500MG; 10MG;1GMtablet, extended release · oralCIPLA LTDPrescription6 Apr 2026
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;500MG; 5MG;1GM; 10MG;500MG; 10MG;1GMtablet, extended release · oralMACLEODS PHARMSPrescription6 Apr 2026
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;500MG; 5MG;1GM; 10MG;500MG; 10MG;1GMtablet, extended release · oralALKEM LABS LTDPrescription6 Apr 2026
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;500MG; 5MG;1GM; 10MG;500MG; 10MG;1GMtablet, extended release · oralLUPINPrescription6 Apr 2026
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE2.5MG;1GM; 5MG;500MG; 5MG;1GM; 10MG;500MG; 10MG;1GMtablet, extended release · oralTEVA PHARMS USA INCPrescription6 Apr 2026
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;1GMtablet, extended release · oralCIPLAPrescription6 Apr 2026

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-DAPAGLIFLOZIN-METFORMIN02536153850 MG; 5 MGTABLET · ORALAPOTEX INC
APO-DAPAGLIFLOZIN-METFORMIN025361611000 MG; 5 MGTABLET · ORALAPOTEX INC
AURO-DAPAGLIFLOZIN / METFORMIN025330735 MG; 850 MGTABLET · ORALAURO PHARMA INC
AURO-DAPAGLIFLOZIN / METFORMIN025330815 MG; 1000 MGTABLET · ORALAURO PHARMA INC
XIGDUO024499355 MG; 850 MGTABLET · ORALASTRAZENECA CANADA INC
XIGDUO024499435 MG; 1000 MGTABLET · ORALASTRAZENECA CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACDAPAGLIFLOZIN-METFORMIN ER 10-1,000 MG TABLET$0.71952per EA23 Sep 2026
US NADACDAPAGLIFLOZIN-METFORMIN ER 10-500 MG TABLET$0.80198per EA23 Sep 2026
US NADACDAPAGLIFLOZIN-METFORMIN ER 5-1,000 MG TABLET$0.46063per EA23 Sep 2026
US NADACDAPAGLIFLOZIN-METFORMIN ER 5-500 MG TABLET$0.70725per EA23 Sep 2026
NHS Drug TariffDapagliflozin 5mg / Metformin 1g tablets£36.5956 tablet1 Oct 2026
NHS Drug TariffDapagliflozin 5mg / Metformin 850mg tablets£36.5956 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.

Components

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.