Is Aminosalicylic acid approved by the US FDA?

Drugs@FDA lists 2 application product lines for Aminosalicylic acid, including PASER (Prescription); PARASAL (Discontinued).

Is Aminosalicylic acid authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 1 product containing Aminosalicylic acid, including PASER 4G, GASTRO-RESISTANT GRANULES.

Active substance

Aminosalicylic acid

US FDA 2
UK MHRA 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
PASER	4GM/PACKET	granule, delayed release · oral	ADAPTIS	Prescription	30 Jun 1994
PARASAL	500MG; 1GM	tablet · oral	PANRAY	Discontinued

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
PASER 4G, GASTRO-RESISTANT GRANULES	PLGB 35068/0003	EUROCEPT INTERNATIONAL BV	POM

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.