FDA NDA · NDA205109

VELPHORO

sucroferric oxyhydroxide

Sponsor: VIFOR FRESENIUS

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APPLICATION
NDA205109
TYPE
NDA
ORIGINAL APPROVAL
2013-11-27
LATEST ACTION
2026-10-13
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription

Products

VELPHORO · ReferencePrescription
FERRIC OXYHYDROXIDE EQ 500MG IRON · TABLET, CHEWABLE · ORAL

Approval history

2026-10-13Efficacy · Supplement 14 · standard — Letter ↗AP
2024-08-27Labeling · Supplement 10 · standard — Letter ↗AP
2024-07-01Efficacy · Supplement 9 · standard — Letter ↗AP
2020-02-28Labeling · Supplement 8 · standard — Label ↗AP
2018-04-25Labeling · Supplement 6 · standard — Label ↗AP
2017-08-03Labeling · Supplement 5 · standard — Label ↗AP
2015-06-12Manufacturing (CMC) · Supplement 2 · standardAP
2014-09-24Labeling · Supplement 1 · standard — Label ↗AP
2013-11-27Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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