FDA — authorised 8 August 2025
- Application: ANDA208977
- Marketing authorisation holder: INTL MEDICATION SYS
- Local brand name: IRON SUCROSE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 Venofer® 200 mg in United States
FDA authorised Venofer® 200 mg on 8 August 2025
Marketing authorisations
FDA — authorised 8 August 2025
- Application: ANDA212559
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: IRON SUCROSE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA
- Status: approved
Venofer® 200 mg in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Venofer® 200 mg approved in United States?
Yes. FDA authorised it on 8 August 2025; FDA authorised it on 8 August 2025; FDA has authorised it.
Who is the marketing authorisation holder for Venofer® 200 mg in United States?
INTL MEDICATION SYS holds the US marketing authorisation.