FDA — authorised 18 July 1986
- Marketing authorisation holder: GD SEARLE LLC
- Status: approved
🇺🇸 Iron Fumarate in United States
FDA authorised Iron Fumarate on 18 July 1986
Marketing authorisations
FDA — authorised 23 April 2014
- Application: ANDA203371
- Marketing authorisation holder: XIROMED
- Status: approved
FDA — authorised 1 December 2014
- Application: ANDA090938
- Marketing authorisation holder: BARR LABS
- Local brand name: FERROUS FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 February 2022
- Application: ANDA204847
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 3 March 2022
- Application: ANDA202994
- Marketing authorisation holder: NOVAST LABS
- Indication: Labeling
- Status: approved
FDA — authorised 13 June 2024
- Application: ANDA213317
- Marketing authorisation holder: XIROMED
- Indication: Labeling
- Status: approved
The FDA approved XIROMED's Iron Fumarate on June 13, 2024, for labeling indications. This approval was granted under the standard expedited pathway. The marketing authorization holder is XIROMED, and the application number is ANDA213317.
Iron Fumarate 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 Iron Fumarate approved in United States?
Yes. FDA authorised it on 18 July 1986; FDA authorised it on 23 April 2014; FDA authorised it on 1 December 2014.
Who is the marketing authorisation holder for Iron Fumarate in United States?
GD SEARLE LLC holds the US marketing authorisation.