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FDA NDA · NDA022180

FERAHEME

ferumoxytol

Sponsor: AZURITY

APPLICATION
NDA022180
TYPE
NDA
ORIGINAL APPROVAL
2009-06-30
LATEST ACTION
2026-05-27
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

FERAHEME · ReferencePrescription
FERUMOXYTOL EQ 510MG IRON/17ML (EQ 30MG IRON/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-05-27Labeling · Supplement 26 · standard — Letter ↗AP
2022-06-16Labeling · Supplement 25 · standard — Letter ↗AP
2020-09-11Labeling · Supplement 24 · standard — Letter ↗AP
2019-10-11Labeling · Supplement 23 · standard — Label ↗AP
2018-02-02Efficacy · Supplement 9 · standard — Label ↗AP
2017-12-22Labeling · Supplement 16 · standard — Letter ↗AP
2016-11-15Manufacturing (CMC) · Supplement 17 · standardAP
2015-10-28Manufacturing (CMC) · Supplement 14 · standardAP
2015-10-26Manufacturing (CMC) · Supplement 15 · standardAP
2015-07-27Manufacturing (CMC) · Supplement 12 · standardAP
2015-03-16Labeling · Supplement 13 · standard — Label ↗AP
2015-03-16Labeling · Supplement 11 · standard — Label ↗AP
2013-12-23Manufacturing (CMC) · Supplement 10 · standard — Label ↗AP
2012-06-05Labeling · Supplement 7 · unknownAP
2011-06-21Labeling · Supplement 6 · unknown — Letter ↗AP
2010-11-24Labeling · Supplement 5 · 901 required — Letter ↗AP
2010-11-24Labeling · Supplement 3 · unknown — Label ↗AP
2009-06-30Type 2 - New Active Ingredient · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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