← FDA DRUG APPROVALS

FDA NDA · NDA208030

FERRIPROX

deferiprone

Sponsor: CHIESI

APPLICATION
NDA208030
TYPE
NDA
ORIGINAL APPROVAL
2015-09-09
LATEST ACTION
2025-03-26
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued, Prescription

Products

FERRIPROX · ReferenceDiscontinued
DEFERIPRONE 80MG/ML · SOLUTION · ORAL
FERRIPROX · ReferencePrescription
DEFERIPRONE 100MG/ML · SOLUTION · ORAL

Approval history

2025-03-26Labeling · Supplement 9 · standard — Label ↗AP
2021-11-30Labeling · Supplement 7 · standard — Letter ↗AP
2021-04-30Efficacy · Supplement 5 · standard — Label ↗AP
2020-02-20Labeling · Supplement 4 · standard — Letter ↗AP
2018-04-20Efficacy · Supplement 2 · standard — Letter ↗AP
2015-09-09Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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