Ferumoxytol

Treats iron deficiency anemia (IDA). ANDA 206604, held by Sandoz. Ferumoxytol.

As of Nov 15, 2026, ANDA 206604 (Ferumoxytol), held by Sandoz, was first approved by FDA on Jan 15, 2021, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 15, 2021
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ferumoxytol is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

who have intolerance to oral iron or have had unsatisfactory response to oral iron
who have chronic kidney disease (CKD).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 15, 2021	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
FerumoxytolEQ 510MG IRON/17ML (EQ 30MG IRON/ML) · solution;intravenous	Ferumoxytol	Rx

All 2 submissions, including labeling and manufacturing supplements


Dec 16, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Jan 15, 2021	Original application	Approved	Letter

Identifiers

Application: ANDA 206604
Drugs@FDA: Overview at FDA
Company: Sandoz

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters