TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

FENOFIBRATE (MICRONIZED)

FENOFIBRATE
Approved 2002-04-09
Jump to: Indications Approvals Trials Competitors Safety Patents
17
Indications
--
Phase 3 Trials
23
Years on Market

Details

Status
Discontinued
First Approved
2002-04-09
Routes
ORAL
Dosage Forms
CAPSULE

Companies

IMPAX LABS INVAGEN PHARMS ANI PHARMS Sun Pharma RISING Aurobindo Pharma ALEMBIC NOVAST LABS REYOUNG TORRENT RHODES PHARMS AJANTA PHARMA LTD CHARTWELL RX Apotex PHARMOBEDIENT CHARTWELL GLENMARK PHARMS LTD
Active Ingredient: FENOFIBRATE

FENOFIBRATE (MICRONIZED) Approval History

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What FENOFIBRATE (MICRONIZED) Treats

17 FDA approvals

Originally approved for its first indication in 2002 . Covers 17 distinct patient populations.

  • Other (17)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

FENOFIBRATE (MICRONIZED) FDA Label Details

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Data Sources

FDA Approval: ANDA075868 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.