FDA — authorised 16 January 2020
- Marketing authorisation holder: PHARMACOSMOS AS
- Status: approved
🇺🇸 Monoferric in United States
FDA authorised Monoferric on 16 January 2020
Marketing authorisations
FDA — authorised 11 September 2020
- Application: NDA208171
- Marketing authorisation holder: PHARMACOSMOS
- Indication: Labeling
- Status: approved
Monoferric 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 Monoferric approved in United States?
Yes. FDA authorised it on 16 January 2020; FDA authorised it on 11 September 2020.
Who is the marketing authorisation holder for Monoferric in United States?
PHARMACOSMOS AS holds the US marketing authorisation.