Is Atorvastatin + Ezetimibe registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Atorvastatin + Ezetimibe, including ATOZET 10/10 mg film-coated tablet (10,10 mg,mg, Film-coated tablet, SAR 124.55); ATOZET 10/20 mg film-coated tablet (10,20 mg,mg, Film-coated tablet, SAR 129.20); ATOZET 10/40 mg film-coated tablet (10,40 mg,mg, Film-coated tablet, SAR 135.10); Atomibe (10,10 mg,mg, Film-coated tablet, SAR 116.25); Atomibe (20,10 mg,mg, Film-coated tablet, SAR 120.60).

Is Atorvastatin + Ezetimibe approved by the US FDA?

Drugs@FDA lists 2 application product lines for Atorvastatin + Ezetimibe, including LIPTRUZET (Discontinued); LYPQOZET (Discontinued).

Active substances

Atorvastatin + Ezetimibe

SFDA 6
US FDA 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ATOZET 10/10 mg film-coated tablet	10,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 124.55	NCE · Prescription	N.V. Organon	Valid
ATOZET 10/20 mg film-coated tablet	10,20 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 129.20	NCE · Prescription	N.V. Organon	Valid
ATOZET 10/40 mg film-coated tablet	10,40 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 135.10	NCE · Prescription	N.V. Organon	Valid
Atomibe	10,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 116.25	Generic · Prescription	Saudi Amarox	Valid
Atomibe	20,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 120.60	Generic · Prescription	Saudi Amarox	Valid
Atomibe	40,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 126.10	Generic · Prescription	Saudi Amarox	Valid

Indications — CHI Daman Drug Formulary

CORONARY ARTERY DISEASE; DYSLIPIDEMIA

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

Product	Strength	Form · route	Applicant	Status	First approved
LIPTRUZET	EQ 10MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	ORGANON	Discontinued	3 May 2013
LYPQOZET	EQ 10MG BASE;10MG; EQ 20MG BASE;10MG; EQ 40MG BASE;10MG; EQ 80MG BASE;10MG	tablet · oral	PHARMOBEDIENT	Discontinued	26 Apr 2017

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.