FDA — authorised 30 December 1988
- Application: NDA019829
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: CERETEC
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Ceretec in United States
FDA authorised Ceretec on 30 December 1988
Marketing authorisations
FDA — authorised 17 August 2017
- Application: NDA208870
- Marketing authorisation holder: JUBILANT
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
Ceretec in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Ceretec approved in United States?
Yes. FDA authorised it on 30 December 1988; FDA authorised it on 17 August 2017.
Who is the marketing authorisation holder for Ceretec in United States?
GE HEALTHCARE holds the US marketing authorisation.