FDA NDA · NDA205874

FERRIC CITRATE

Sponsor: KERYX BIOPHARMS

APPLICATION

NDA205874

TYPE

NDA

ORIGINAL APPROVAL

2014-09-05

LATEST ACTION

2024-01-19

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription

Products

AURYXIA · ReferencePrescription

FERRIC CITRATE EQ 210MG IRON · TABLET · ORAL

2024-01-19Labeling · Supplement 29 · standard — Label ↗AP

2021-03-10Labeling · Supplement 27 · standard — Label ↗AP

2017-11-06Efficacy · Supplement 13 · standard — Label ↗AP

2016-12-19Manufacturing (CMC) · Supplement 11 · standardAP

2016-11-09Manufacturing (CMC) · Supplement 10 · standardAP

2016-05-02Manufacturing (CMC) · Supplement 8 · standardAP

2015-08-27Manufacturing (CMC) · Supplement 7 · standardAP

2015-08-04Manufacturing (CMC) · Supplement 6 · standardAP

2015-07-21Labeling · Supplement 4 · standard — Label ↗AP

2015-07-14Manufacturing (CMC) · Supplement 5 · standardAP

2015-05-22Manufacturing (CMC) · Supplement 3 · standardAP

2015-05-18Manufacturing (CMC) · Supplement 2 · standardAP

2014-11-15Labeling · Supplement 1 · standard — Label ↗AP

2014-09-05Type 5 - New Formulation or New Manufacturer · Original · standard — Summary Review ↗AP

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.

Weekly Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.