SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| METHYLENE BLUE 1%(50MG-5ML) AMP | 1 % | Injection · Parenteral use | 5 Ampoule | SAR 129.85 | Generic · Prescription | HOSPIRA AUSTRALIA | Withdrawn by MAH · Not Marketed |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| PROVAYBLUE | 50MG/10ML (5MG/ML); 10MG/2ML (5MG/ML) | solution · intravenous | PROVEPHARM SAS | Prescription | 8 Apr 2016 |
| METHYLENE BLUE | 10MG/2ML (5MG/ML); 50MG/10ML (5MG/ML); 5MG/ML (5MG/ML); 100MG/10ML (10MG/ML) | solution · intravenous | ZYDUS LIFESCIENCES | Prescription | 5 Dec 2023 |
| METHYLENE BLUE | 50MG/10ML (5MG/ML) | solution · intravenous | NEXUS | Prescription | 21 Nov 2024 |
| METHYLENE BLUE | 50MG/10ML (5MG/ML) | solution · intravenous | STERISCIENCE | Prescription | 22 Nov 2024 |
| METHYLENE BLUE | 50MG/10ML (5MG/ML) | solution · intravenous | HIKMA PHARMS | Prescription | 17 Dec 2024 |
| METHYLENE BLUE | 50MG/10ML (5MG/ML) | solution · intravenous | MEITHEAL | Prescription | 23 Jan 2025 |
| METHYLENE BLUE | 50MG/10ML (5MG/ML) | solution · intravenous | XIROMED | Prescription | 30 Jul 2025 |
| METHYLENE BLUE | 50MG/10ML (5MG/ML) | solution · intravenous | CHENGDU SHUODE | Prescription | 23 Dec 2025 |
Canada Canada — marketed products (Health Canada)
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.