Is Acetylsalicylic acid + Dipyridamole approved by the US FDA?

Drugs@FDA lists 12 application product lines for Acetylsalicylic acid + Dipyridamole, including ASPIRIN AND DIPYRIDAMOLE (Prescription); ASPIRIN AND DIPYRIDAMOLE (Prescription); ASPIRIN AND DIPYRIDAMOLE (Prescription); ASPIRIN AND DIPYRIDAMOLE (Prescription); ASPIRIN AND DIPYRIDAMOLE (Prescription).

Is Acetylsalicylic acid + Dipyridamole authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 1 product containing Acetylsalicylic acid + Dipyridamole, including SVELUX 200MG/25MG MODIFIED RELEASE CAPSULES, HARD.

Active substances

Acetylsalicylic acid + Dipyridamole

US FDA 12
UK MHRA 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
ASPIRIN AND DIPYRIDAMOLE	25MG;200MG	capsule, extended release · oral	BARR	Prescription	14 Aug 2009
ASPIRIN AND DIPYRIDAMOLE	25MG;200MG	capsule, extended release · oral	AMNEAL PHARMS	Prescription	8 Mar 2016
ASPIRIN AND DIPYRIDAMOLE	25MG;200MG	capsule, extended release · oral	SANDOZ	Prescription	18 Jan 2017
ASPIRIN AND DIPYRIDAMOLE	25MG;200MG	capsule, extended release · oral	PH HEALTH	Prescription	18 Jan 2017
ASPIRIN AND DIPYRIDAMOLE	25MG;200MG	capsule, extended release · oral	ZYDUS PHARMS	Prescription	29 Aug 2017
ASPIRIN AND DIPYRIDAMOLE	25MG;200MG	capsule, extended release · oral	DR REDDYS	Prescription	10 Oct 2018
ASPIRIN AND DIPYRIDAMOLE	25MG;200MG	capsule, extended release · oral	GLENMARK SPECLT	Prescription	24 May 2019
ASPIRIN AND DIPYRIDAMOLE	25MG;200MG	capsule, extended release · oral	MICRO LABS	Prescription	11 Aug 2021
AGGRENOX	25MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule, extended release · oral	BOEHRINGER INGELHEIM	Discontinued	22 Nov 1999
ASPIRIN AND DIPYRIDAMOLE	25MG;200MG	capsule, extended release · oral	ANI PHARMS	Discontinued	18 Jan 2017
ASPIRIN AND DIPYRIDAMOLE	25MG;200MG	capsule, extended release · oral	SUN PHARM	Discontinued	21 Aug 2018
ASPIRIN AND DIPYRIDAMOLE	25MG;200MG	capsule, extended release · oral	CHARTWELL MOLECULAR	Discontinued	20 Mar 2019

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
SVELUX 200MG/25MG MODIFIED RELEASE CAPSULES, HARD	PL 04416/1362	SANDOZ LIMITED	POM

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.