FDA — authorised 28 November 2017
- Application: NDA209589
- Marketing authorisation holder: FERRING PHARMS INC
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA authorised Prepopik on 28 November 2017
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 28 November 2017.
FERRING PHARMS INC holds the US marketing authorisation.