← FDA DRUG APPROVALS

FDA NDA · NDA019304

TRICOR (MICRONIZED)

Sponsor: ABBVIE

APPLICATION
NDA019304
TYPE
NDA
ORIGINAL APPROVAL
1993-12-31
LATEST ACTION
2002-03-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

TRICOR (MICRONIZED) · ReferenceDiscontinued
FENOFIBRATE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
TRICOR (MICRONIZED) · ReferenceDiscontinued
FENOFIBRATE 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
TRICOR (MICRONIZED) · ReferenceDiscontinued
FENOFIBRATE 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
LIPIDILDiscontinued
FENOFIBRATE 100MG · CAPSULE · ORAL

Approval history

2002-03-19Manufacturing (CMC) · Supplement 6 · standardAP
2000-04-24Efficacy · Supplement 5 · unknown — Review ↗AP
1999-06-30Manufacturing (CMC) · Supplement 3 · standardAP
1999-06-28Manufacturing (CMC) · Supplement 4 · standardAP
1999-04-27Manufacturing (CMC) · Supplement 2 · standardAP
1998-02-09Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
1993-12-31Type 1 - New Molecular Entity · Original · standard — Review ↗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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