FDA — authorised 26 April 2019
- Application: NDA202153
- Marketing authorisation holder: JUBILANT
- Indication: Labeling
- Status: approved
🇺🇸 Rubidium Bromatum in United States
FDA authorised Rubidium Bromatum on 26 April 2019
Marketing authorisations
FDA — authorised 15 October 2020
- Application: NDA019414
- Marketing authorisation holder: BRACCO
- Indication: Efficacy
- Status: approved
FDA
- Marketing authorisation holder: JUBILANT
- Status: approved
Rubidium Bromatum in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Rubidium Bromatum approved in United States?
Yes. FDA authorised it on 26 April 2019; FDA authorised it on 15 October 2020; FDA has authorised it.
Who is the marketing authorisation holder for Rubidium Bromatum in United States?
JUBILANT holds the US marketing authorisation.