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Data updated: Mar 10, 2026

COLESTID

COLESTIPOL HYDROCHLORIDE
Cardiovascular Approved 1977-04-04
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
2
Indications
--
Phase 3 Trials
2
Priority Reviews
48
Years on Market

Details

Status
Prescription
First Approved
1977-04-04
Routes
ORAL
Dosage Forms
TABLET, GRANULE

Companies

Pfizer
Active Ingredient: COLESTIPOL HYDROCHLORIDE

COLESTID Approval History

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What COLESTID Treats

2 indications

COLESTID is approved for 2 conditions since its original approval in 1977. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypercholesterolemia
  • Atherosclerotic Vascular Disease
Source: FDA Label

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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.

COLESTID FDA Label Details

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Indications & Usage

FDA Label (PDF)

Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. COLESTID Granules and FLAVORED COLESTID Granules are indicated as adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein (LDL) cholesterol in patients with primary hypercholesterolemia (elevated low density lipoproteins [LDL] cholesterol) who do not respond adequately to diet. Generally, COLESTID and FLAVORED COLESTID have no clinically significant effect on serum triglycerides, but with its ...

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Data Sources

FDA Approval: NDA020222 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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