FDA — authorised 31 July 1978
- Application: NDA017441
- Marketing authorisation holder: ALLERGAN
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Elemental Iron (As Carbonyl Iron) in United States
FDA authorised Elemental Iron (As Carbonyl Iron) on 31 July 1978
Marketing authorisations
FDA — authorised 17 October 2005
- Application: NDA021135
- Marketing authorisation holder: AM REGENT
- Indication: Efficacy
- Status: approved
FDA — authorised 8 August 2025
- Application: ANDA212340
- Marketing authorisation holder: SANDOZ
- Status: approved
FDA — authorised 8 August 2025
- Application: ANDA212559
- Marketing authorisation holder: MYLAN LABS LTD
- Status: approved
FDA — authorised 8 August 2025
- Application: ANDA208977
- Marketing authorisation holder: INTL MEDICATION SYS
- Status: approved
FDA
- Status: approved
Elemental Iron (As Carbonyl Iron) 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 Elemental Iron (As Carbonyl Iron) approved in United States?
Yes. FDA authorised it on 31 July 1978; FDA authorised it on 17 October 2005; FDA authorised it on 8 August 2025.
Who is the marketing authorisation holder for Elemental Iron (As Carbonyl Iron) in United States?
ALLERGAN holds the US marketing authorisation.