TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

GEMFIBROZIL

GEMFIBROZIL
Approved 1993-01-25
Jump to: Indications Approvals Trials Competitors Safety Patents
17
Indications
--
Phase 3 Trials
33
Years on Market

Details

Status
Discontinued
First Approved
1993-01-25
Routes
ORAL
Dosage Forms
TABLET, CAPSULE

Companies

Sun Pharma CADILA PHARMS LTD CHARTWELL RX PUREPAC PHARM Teva PHARMOBEDIENT WATSON LABS INVAGEN PHARMS Hikma IMPAX PHARMS NATCO Aurobindo Pharma CADILA NORTHSTAR HLTHCARE EPIC PHARMA LLC ASCENT PHARMS INC CHARTWELL MOLECULES Apotex
Active Ingredient: GEMFIBROZIL

GEMFIBROZIL Approval History

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What GEMFIBROZIL Treats

17 FDA approvals

Originally approved for its first indication in 1993 . 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.

GEMFIBROZIL FDA Label Details

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Data Sources

FDA Approval: ANDA079239 → Trials: ClinicalTrials.gov →

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