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FDA NDA · NDA021695

FENOFIBRATE

Sponsor: LUPIN

APPLICATION
NDA021695
TYPE
NDA
ORIGINAL APPROVAL
2004-11-30
LATEST ACTION
2025-10-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued, Prescription

Products

ANTARA (MICRONIZED) · ReferenceDiscontinued
FENOFIBRATE 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
ANTARA (MICRONIZED) · ReferencePrescription
FENOFIBRATE 130MG · CAPSULE · ORAL
ANTARA (MICRONIZED) · ReferencePrescription
FENOFIBRATE 43MG · CAPSULE · ORAL
ANTARA (MICRONIZED) · ReferenceDiscontinued
FENOFIBRATE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
ANTARA (MICRONIZED)Discontinued
FENOFIBRATE 87MG · CAPSULE · ORAL

Approval history

2025-10-01Labeling · Supplement 29 · standard — Label ↗AP
2024-07-30Labeling · Supplement 28 · standard — Letter ↗AP
2021-06-03Labeling · Supplement 22 · 901 required — Label ↗AP
2019-05-15Labeling · Supplement 20 · 901 required — Letter ↗AP
2019-02-04Manufacturing (CMC) · Supplement 18 · standard — Label ↗AP
2018-11-07Labeling · Supplement 19 · standard — Label ↗AP
2018-05-18Labeling · Supplement 17 · 901 required — Label ↗AP
2017-09-11Labeling · Supplement 16 · standard — Label ↗AP
2016-11-29Manufacturing (CMC) · Supplement 14 · standardAP
2016-11-09Manufacturing (CMC) · Supplement 13 · standardAP
2015-08-31Manufacturing (CMC) · Supplement 12 · standard — Label ↗AP
2014-09-04Manufacturing (CMC) · Supplement 11 · standardAP
2013-10-18Manufacturing (CMC) · Supplement 9 · standard — Label ↗AP
2012-12-19Labeling · Supplement 10 · standard — Letter ↗AP
2012-03-01Labeling · Supplement 8 · standard — Label ↗AP
2008-06-03Labeling · Supplement 6 · standard — Label ↗AP
2005-10-21Efficacy · Supplement 1 · unknown — Letter ↗AP
2004-11-30Type 3 - New Dosage Form · 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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