Is Candesartan + Hydrochlorothiazide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 9 valid registrations of Candesartan + Hydrochlorothiazide, including ATACAND PLUS TABLET (16,12.5 mg,mg, Tablet, SAR 68.30); BLOPRESS 16 PLUS TABLETS (16,12.5 mg,mg, Tablet, SAR 54.65); BLOPRESS 8 PLUS TABLETS (8,12.5 mg,mg, Tablet, SAR 47.70); CANDAN PLUS 16/12.5 mg tablet (16,12.5 mg,mg, Tablet, SAR 51.35); CANDEZA 16/12.5 mg TABLETS (16,12.5 mg,mg, Tablet, SAR 34.45).

Is Candesartan + Hydrochlorothiazide approved by the US FDA?

Drugs@FDA lists 8 application product lines for Candesartan + Hydrochlorothiazide, including ATACAND HCT (Prescription); CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (Prescription); CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (Prescription); CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (Prescription); CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (Prescription).

Active substances

Candesartan + Hydrochlorothiazide

SFDA 9
US FDA 8
Health Canada 22
US price lines 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ATACAND PLUS TABLET	16,12.5 mg,mg	Tablet · Oral use	28 Blister	SAR 68.30	NCE · Prescription	CHEPLAPHARM Arzneimittel GmbH	Valid
BLOPRESS 16 PLUS TABLETS	16,12.5 mg,mg	Tablet · Oral use	28 Blister	SAR 54.65	Generic · Prescription	APM	Valid
BLOPRESS 8 PLUS TABLETS	8,12.5 mg,mg	Tablet · Oral use	28 Blister	SAR 47.70	Generic · Prescription	APM	Valid
CANDAN PLUS 16/12.5 mg tablet	16,12.5 mg,mg	Tablet · Oral use	30 Blister	SAR 51.35	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
CANDEZA 16/12.5 mg TABLETS	16,12.5 mg,mg	Tablet · Oral use	28 Blister	SAR 34.45	Generic · Prescription	SPIMACO ADDWAEIH	Valid
CANDEZA 8/12.5 mg TABLETS	16,12.5 mg,mg	Tablet · Oral use	28 Blister	SAR 23.45	Generic · Prescription	SPIMACO ADDWAEIH	Valid
CoDICERAN 16/12.5 film-coated tablet	16,12.5 mg,mg	Tablet · Oral use	28 Blister	SAR 41.35	Generic · Prescription	SANDOZ	Valid
GARDIA PLUS 16/12.5MG TABLETS	16,12.5 mg,mg	Tablet · Oral use	30 Blister	SAR 34.45	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
GARDIA PLUS 8/12.5MG TABLETS	16,12.5 mg,mg	Tablet · Oral use	30 Blister	SAR 23.45	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid

Indications — CHI Daman Drug Formulary

HYPERTENSION

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

Product	Strength	Form · route	Applicant	Status	First approved
ATACAND HCT	16MG;12.5MG; 32MG;12.5MG; 32MG;25MG	tablet · oral	ANI PHARMS	Prescription	5 Sep 2000
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG	tablet · oral	PHARMOBEDIENT	Prescription	4 Dec 2012
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG; 32MG;12.5MG; 32MG;25MG	tablet · oral	SENORES PHARMS	Prescription	3 Jun 2013
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG; 32MG;12.5MG; 32MG;25MG	tablet · oral	MACLEODS PHARMS	Prescription	27 Feb 2015
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG; 32MG;12.5MG; 32MG;25MG	tablet · oral	ZYDUS LIFESCIENCES	Prescription	27 Nov 2017
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG; 32MG;12.5MG; 32MG;25MG	tablet · oral	PRINSTON INC	Prescription	11 Apr 2018
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;12.5MG; 32MG;25MG	tablet · oral	PHARMOBEDIENT	Discontinued	4 Dec 2012
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG; 32MG;12.5MG; 32MG;25MG	tablet · oral	APOTEX INC	Discontinued	4 Dec 2012

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ATACAND PLUS	02244021	12.5 MG; 16 MG	TABLET · ORAL	CHEPLAPHARM ARZNEIMITTEL GMBH
ATACAND PLUS	02332922	12.5 MG; 32 MG	TABLET · ORAL	CHEPLAPHARM ARZNEIMITTEL GMBH
ATACAND PLUS	02332957	32 MG; 25 MG	TABLET · ORAL	CHEPLAPHARM ARZNEIMITTEL GMBH
AURO-CANDESARTAN HCT	02421038	12.5 MG; 16 MG	TABLET · ORAL	AURO PHARMA INC
AURO-CANDESARTAN HCT	02421046	12.5 MG; 32 MG	TABLET · ORAL	AURO PHARMA INC
AURO-CANDESARTAN HCT	02421054	25 MG; 32 MG	TABLET · ORAL	AURO PHARMA INC
CANDESARTAN HCT	02394812	12.5 MG; 16 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
CANDESARTAN-HCTZ	02392275	12.5 MG; 16.0 MG	TABLET · ORAL	PRO DOC LIMITEE
CANDESARTAN/HCTZ	02394804	16 MG; 12.5 MG	TABLET · ORAL	SANIS HEALTH INC
CANDESARTAN/HCTZ	02536064	32 MG; 12.5 MG	TABLET · ORAL	SANIS HEALTH INC
JAMP CANDESARTAN-HCT	02473240	16 MG; 12.5 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP CANDESARTAN-HCT	02473259	12.5 MG; 32 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP CANDESARTAN-HCT	02473267	25 MG; 32 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
NRA-CANDESARTAN HCTZ	02531240	16 MG; 12.5 MG	TABLET · ORAL	NORA PHARMA INC
NRA-CANDESARTAN HCTZ	02531259	12.5 MG; 32 MG	TABLET · ORAL	NORA PHARMA INC
NRA-CANDESARTAN HCTZ	02531267	25 MG; 32 MG	TABLET · ORAL	NORA PHARMA INC
PMS-CANDESARTAN-HCTZ	02391295	12.5 MG; 16.0 MG	TABLET · ORAL	PHARMASCIENCE INC
SANDOZ CANDESARTAN PLUS	02327902	12.5 MG; 16 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ CANDESARTAN PLUS	02420732	12.5 MG; 32 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ CANDESARTAN PLUS	02420740	25 MG; 32 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
TEVA-CANDESARTAN/HCTZ	02395541	12.5 MG; 16 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-CANDESARTAN/HCTZ	02395568	12.5 MG; 32 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CANDESARTAN-HYDROCHLOROTHIAZIDE 16-12.5 MG TB	$0.95417	per EA	23 Sep 2026
US NADAC	CANDESARTAN-HYDROCHLOROTHIAZIDE 32-12.5 MG TB	$0.81993	per EA	23 Sep 2026
US NADAC	CANDESARTAN-HYDROCHLOROTHIAZIDE 32-25 MG TAB	$1.07781	per EA	23 Sep 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.