FDA — authorised 8 July 2022
- Application: NDA216264
- Marketing authorisation holder: PROVEPHARM SAS
- Local brand name: BLUDIGO
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Indigotindisulfonate sodium 0.8% in United States
FDA authorised Indigotindisulfonate sodium 0.8% on 8 July 2022
Marketing authorisation
Other Urology approved in United States
Frequently asked questions
Is Indigotindisulfonate sodium 0.8% approved in United States?
Yes. FDA authorised it on 8 July 2022.
Who is the marketing authorisation holder for Indigotindisulfonate sodium 0.8% in United States?
PROVEPHARM SAS holds the US marketing authorisation.