Ferumoxytol
Ferumoxytol: 2 brands, 1 generic; first approved Jun 30, 2009; generic available.
Generic available: 1 ANDA application approved.
Brand (NDA) products
- AZURITYNDA 21986820252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG IRON/10ML (EQ 30MG IRON/ML) SOLUTION INTRAVENOUS Rx — EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION INTRAVENOUS Rx — - AZURITYNDA 0221802009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION INTRAVENOUS Rx AB
Generic (ANDA) products (1)
- FERUMOXYTOLSANDOZANDA 2066042021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION INTRAVENOUS Rx AB
Patent & exclusivity timeline
Marketing exclusivity
- NPNew product exclusivity (3 years)
in 2 yr 3 mo
- NPNew product exclusivity (3 years)
in 2 yr 3 mo
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 2009–2025 across 3 FDA applications.
Ferumoxytol: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
