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Data updated: Mar 10, 2026

COLESTIPOL HYDROCHLORIDE

COLESTIPOL HYDROCHLORIDE
Cardiovascular Approved 2006-05-02
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
7
Indications
--
Phase 3 Trials
19
Years on Market

Details

Status
Prescription
First Approved
2006-05-02
Routes
ORAL
Dosage Forms
TABLET, GRANULE

Companies

ZYDUS PHARMS IMPAX LABS PHARMOBEDIENT RICONPHARMA LLC EDENBRIDGE PHARMS ANI PHARMS
Active Ingredient: COLESTIPOL HYDROCHLORIDE

COLESTIPOL HYDROCHLORIDE Approval History

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What COLESTIPOL HYDROCHLORIDE Treats

2 indications

COLESTIPOL HYDROCHLORIDE is approved for 2 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypercholesterolemia
  • Atherosclerotic Vascular Disease
Source: FDA Label

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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.

COLESTIPOL HYDROCHLORIDE FDA Label Details

Pro

Indications & Usage

INDICATIONS & USAGE Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet. Generally, colestipol hydrochloride tablets have no clinically significant effect on serum triglycerides, but with their use, triglyceride levels may be raised in some patients. Therapy ...

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Data Sources

FDA Approval: ANDA215223 → Label: DailyMed → Trials: ClinicalTrials.gov →

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