← FDA DRUG APPROVALS

FDA NDA · NDA021825

FERRIPROX

deferiprone

Sponsor: CHIESI

APPLICATION
NDA021825
TYPE
NDA
ORIGINAL APPROVAL
2011-10-14
LATEST ACTION
2025-03-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

FERRIPROX · ReferencePrescription
DEFERIPRONE 1GM · TABLET · ORAL
FERRIPROX · ReferenceDiscontinued
DEFERIPRONE 500MG · TABLET · ORAL

Approval history

2025-03-26Labeling · Supplement 12 · standard — Label ↗AP
2021-11-30Labeling · Supplement 10 · standard — Letter ↗AP
2021-04-30Efficacy · Supplement 8 · standard — Label ↗AP
2020-02-20Labeling · Supplement 7 · standard — Letter ↗AP
2019-07-25Efficacy · Supplement 4 · standard — Letter ↗AP
2015-02-24Labeling · Supplement 3 · standard — Label ↗AP
2012-11-15Manufacturing (CMC) · Supplement 2 · standardAP
2012-04-20Labeling · Supplement 1 · standard — Letter ↗AP
2011-10-14Type 1 - New Molecular Entity · 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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