TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

COLESEVELAM HYDROCHLORIDE

COLESEVELAM HYDROCHLORIDE
Approved 2018-05-16
Jump to: Indications Approvals Trials Competitors Safety Patents
17
Indications
--
Phase 3 Trials
7
Years on Market

Details

Status
Discontinued
First Approved
2018-05-16
Routes
ORAL
Dosage Forms
TABLET, FOR SUSPENSION

Companies

WATSON LABS INC BEIJING TIDE PHARM BIONPHARMA INVENTIA ALKEM LABS LTD CHARTWELL RX ZYDUS PHARMS INVAGEN PHARMS MACLEODS PHARMS LTD UNITED RES LABS IMPAX IMPAX LABS INC GLENMARK PHARMS LTD ZHEJIANG JINGXIN Dr. Reddy's
Active Ingredient: COLESEVELAM HYDROCHLORIDE

COLESEVELAM HYDROCHLORIDE Approval History

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What COLESEVELAM HYDROCHLORIDE Treats

17 FDA approvals

Originally approved for its first indication in 2018 . 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.

COLESEVELAM HYDROCHLORIDE FDA Label Details

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Data Sources

FDA Approval: ANDA200830 → Trials: ClinicalTrials.gov →

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