FDA — authorised 10 June 2004
- Marketing authorisation holder: EMMAUS MEDCL
- Status: approved
🇺🇸 Nutrestore in United States
FDA authorised Nutrestore on 10 June 2004
Marketing authorisations
FDA — authorised 7 July 2017
- Application: NDA208587
- Marketing authorisation holder: EMMAUS MEDCL
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 8 July 2024
- Application: ANDA215647
- Marketing authorisation holder: NOVITIUM PHARMA
- Status: approved
Nutrestore in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Nutrestore approved in United States?
Yes. FDA authorised it on 10 June 2004; FDA authorised it on 7 July 2017; FDA authorised it on 8 July 2024.
Who is the marketing authorisation holder for Nutrestore in United States?
EMMAUS MEDCL holds the US marketing authorisation.