FDA — authorised 11 January 2016
- Application: NDA208036
- Marketing authorisation holder: BRACCO
- Local brand name: E-Z-PAQUE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA authorised E-Z-Hd on 11 January 2016
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 11 January 2016; FDA authorised it on 14 October 2016; FDA authorised it on 23 January 2018.
BRACCO holds the US marketing authorisation.