TheraRadar
Data updated: May 26, 2026

COLESTIPOL HYDROCHLORIDE

Metabolic Approved 2006-05-02

COLESTIPOL HYDROCHLORIDE is indicated for the treatment of Hypercholesterolemia; Atherosclerotic Vascular Disease.

Source: FDA Label • IMPAX LABS
7
Indications
--
Phase 3 Trials
20
Years on Market

Details

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

COLESTIPOL HYDROCHLORIDE Approval History

2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2006 to 2026
Apr 2026 SUPPL
Label · Labeling
Sep 2025 ORIGINAL
Update
Dec 2024 ORIGINAL
Update

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

COLESTIPOL HYDROCHLORIDE Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Active Pipeline

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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

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

Indications & Usage

COLESTIPOL HYDROCHLORIDE is indicated for the treatment of Hypercholesterolemia; Atherosclerotic Vascular Disease.

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COLESTID

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Data Sources

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