Regulatory PathRegulatory requirements compared

Active substance

Trypan blue

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
VISIONBLUE0.06%solution · ophthalmicDORCPrescription16 Dec 2004
MEMBRANEBLUE0.15%solution · ophthalmicDORCDiscontinued20 Feb 2009

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
VISIONBLUE022795250.06 %SOLUTION · INTRAOCULARDUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV

Safety signals and safety-related labeling changes

All safety entries for trypan blue →

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.