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Medicines · US (FDA)

FDA 2020

Bile acid sequestrants

Colesevelam Hydrochloride

Approved 2 Sept 2020OralTablet

The FDA lists this product in 20 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: COLESEVELAM HYDROCHLORIDE 625MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET · For suspensionANDA202190-002 · Prescription
COLESEVELAM HYDROCHLORIDE 1.875GM/PACKET · For suspensionANDA202190-001 · Prescription
COLESEVELAM HYDROCHLORIDE 625MG · TabletANDA209038-001 · Prescription
COLESEVELAM HYDROCHLORIDE 625MG · TabletANDA091600-001 · Prescription
COLESEVELAM HYDROCHLORIDE 625MG · TabletThis page
COLESEVELAM HYDROCHLORIDE 625MG · TabletANDA206036-001 · Prescription
COLESEVELAM HYDROCHLORIDE 625MG · TabletANDA208670-001 · Prescription
COLESEVELAM HYDROCHLORIDE 625MG · TabletANDA204893-001 · Discontinued
COLESEVELAM HYDROCHLORIDE 625MG · TabletANDA210889-001 · Prescription
COLESEVELAM HYDROCHLORIDE 625MG · Tablet

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ANDA212050-001 · Prescription

COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET · For suspensionANDA210316-001 · Prescription

COLESEVELAM HYDROCHLORIDE 625MG · TabletANDA209946-001 · Prescription

COLESEVELAM HYDROCHLORIDE 625MG · TabletANDA207765-001 · Prescription

COLESEVELAM HYDROCHLORIDE 625MG · TabletANDA213456-001 · Discontinued

COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET · For suspensionANDA212886-001 · Discontinued

COLESEVELAM HYDROCHLORIDE 625MG · TabletANDA203480-001 · Prescription

COLESEVELAM HYDROCHLORIDE 625MG · TabletANDA212602-001 · Discontinued

COLESEVELAM HYDROCHLORIDE 625MG · TabletANDA201354-001 · Discontinued

COLESEVELAM HYDROCHLORIDE 1.875GM/PACKET · For suspensionANDA202178-001 · Discontinued

COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET · For suspensionANDA202178-002 · Discontinued

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA200830.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Colesevelam Hydrochloride
Drug class: Bile acid sequestrants
Route: Oral
Dosage form: Tablet
Applicant: Watson Labs Inc
Status: Discontinued
FDA approval: 2 Sept 2020
Application: ANDA200830-001
RxCUI: 141625