FDA — authorised 6 November 2000
- Application: NDA021135
- Marketing authorisation holder: AM REGENT
- Local brand name: VENOFER
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 IV trivalent saccharose hydroxide ferrous in United States
FDA authorised IV trivalent saccharose hydroxide ferrous on 6 November 2000
Marketing authorisations
FDA
- Status: approved
IV trivalent saccharose hydroxide ferrous 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 IV trivalent saccharose hydroxide ferrous approved in United States?
Yes. FDA authorised it on 6 November 2000; FDA has authorised it.
Who is the marketing authorisation holder for IV trivalent saccharose hydroxide ferrous in United States?
AM REGENT holds the US marketing authorisation.