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FDA NDA · NDA022418

FIBRICOR

Sponsor: ROSEMONT

APPLICATION
NDA022418
TYPE
NDA
ORIGINAL APPROVAL
2009-08-14
LATEST ACTION
2025-06-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FIBRICOR · ReferenceDiscontinued
FENOFIBRIC ACID 105MG · TABLET · ORAL
FIBRICOR · ReferenceDiscontinued
FENOFIBRIC ACID 35MG · TABLET · ORAL

Approval history

2025-06-06Labeling · Supplement 20 · standard — Label ↗AP
2021-06-03Labeling · Supplement 19 · 901 required — Label ↗AP
2019-09-30Labeling · Supplement 16 · standard — Letter ↗AP
2019-05-15Labeling · Supplement 15 · 901 required — Label ↗AP
2018-05-18Labeling · Supplement 14 · 901 required — Label ↗AP
2015-11-27Manufacturing (CMC) · Supplement 13 · standardAP
2014-01-06Labeling · Supplement 11 · standard — Label ↗AP
2013-03-11Labeling · Supplement 10 · standard — Label ↗AP
2012-12-12Labeling · Supplement 8 · standard — Label ↗AP
2012-12-12Labeling · Supplement 9 · standard — Letter ↗AP
2012-03-15Labeling · Supplement 7 · standard — Letter ↗AP
2012-01-03Labeling · Supplement 6 · standard — Label ↗AP
2009-08-14Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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