FDA — authorised 5 December 2023
- Application: ANDA215636
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: METHYLENE BLUE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Methylthioninium Benzalkonium Chloride Hydrate in United States
FDA authorised Methylthioninium Benzalkonium Chloride Hydrate on 5 December 2023
Marketing authorisations
FDA — authorised 22 November 2024
- Application: ANDA216955
- Marketing authorisation holder: STERISCIENCE
- Local brand name: METHYLENE BLUE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 17 December 2024
- Application: ANDA216959
- Marketing authorisation holder: HIKMA
- Local brand name: METHYLENE BLUE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 23 January 2025
- Application: ANDA217380
- Marketing authorisation holder: MEITHEAL
- Local brand name: METHYLENE BLUE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 30 July 2025
- Application: ANDA219363
- Marketing authorisation holder: XIROMED
- Local brand name: METHYLENE BLUE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- Status: approved
Methylthioninium Benzalkonium Chloride Hydrate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Methylthioninium Benzalkonium Chloride Hydrate approved in United States?
Yes. FDA authorised it on 5 December 2023; FDA authorised it on 22 November 2024; FDA authorised it on 17 December 2024.
Who is the marketing authorisation holder for Methylthioninium Benzalkonium Chloride Hydrate in United States?
ZYDUS LIFESCIENCES holds the US marketing authorisation.