FDA — authorised 27 August 2009
- Application: BLA022210
- Marketing authorisation holder: EURAND PHARMA LTD
- Status: supplemented
🇺🇸 Zenpep in United States
FDA authorised Zenpep on 27 August 2009
Marketing authorisations
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Zenpep approved in United States?
Yes. FDA authorised it on 27 August 2009; FDA has authorised it.
Who is the marketing authorisation holder for Zenpep in United States?
EURAND PHARMA LTD holds the US marketing authorisation.