Welchol

For primary hyperlipidemia. NDA 21176, held by Cosette. Colesevelam Hydrochloride.

As of Nov 14, 2026, NDA 21176 (Welchol), held by Cosette, was first approved by FDA on May 26, 2000, with 31 approved supplements and 0 published complete response letters.

First approved: May 26, 2000
Review: Standard
Supplements approved: 31
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification. improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Do not use for treatment of type 1 diabetes or for diabetic ketoacidosis. Not studied in Fredrickson Type I, III, IV, and V dyslipidemias 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below


Jan 22, 2014	Supplement 37Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 28, 2013	Supplement 34Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 2, 2009	Supplement 22Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Amendment 3 Pediatric Amendment 2
Jan 18, 2008	Supplement 17Efficacy (new indication or use)	Approved	Letter Label
Sep 6, 2006	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 26, 2000	Original applicationNew molecular entity · Standard review	Approved	Letter Label Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Welchol625MG · tablet;oral	Colesevelam Hydrochloride	RxReference drug

All 32 submissions, including labeling and manufacturing supplements


Oct 20, 2021	Supplement 49Labeling · Standard review	Approved	Label Letter
Jul 29, 2020	Supplement 48Labeling · Standard review	Approved	Letter Label
May 12, 2020	Supplement 47Labeling · Standard review	Approved	Letter Label
May 21, 2019	Supplement 45Labeling · Standard review	Approved	Label Letter
Jan 16, 2019	Supplement 44Labeling · Standard review	Approved	Letter Label
Jul 14, 2016	Supplement 40Manufacturing · Standard review	Approved	None posted
May 20, 2014	Supplement 39Manufacturing · Standard review	Approved	None posted
Jan 22, 2014	Supplement 37Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 28, 2013	Supplement 38Labeling · Standard review	Approved	Letter Label
Jun 28, 2013	Supplement 34Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 22, 2013	Supplement 35Manufacturing · Standard review	Approved	None posted
Feb 25, 2013	Supplement 36Manufacturing · Standard review	Approved	None posted
Jul 9, 2012	Supplement 30Labeling	Approved	Letter Label
Jan 3, 2012	Supplement 29Labeling	Approved	Letter Label
Jul 18, 2011	Supplement 28Labeling	Approved	Letter Label
Sep 14, 2010	Supplement 27Labeling	Approved	Label Letter
Oct 2, 2009	Supplement 22Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Amendment 3 Pediatric Amendment 2
May 30, 2008	Supplement 21Manufacturing	Approved	Letter
Jan 18, 2008	Supplement 17Efficacy (new indication or use)	Approved	Letter Label
Aug 27, 2007	Supplement 19Labeling · Standard review	Approved	Label Letter
Sep 6, 2006	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 10, 2006	Supplement 15Labeling · Standard review	Approved	Letter Label
Nov 17, 2003	Supplement 10Manufacturing · Standard review	Approved	Label Letter
Oct 10, 2003	Supplement 9Labeling · Standard review	Approved	Letter Label
Aug 21, 2003	Supplement 8Manufacturing · Standard review	Approved	Letter Label
Feb 11, 2003	Supplement 4Labeling · Standard review	Approved	Letter Label
Oct 17, 2002	Supplement 5Manufacturing · Standard review	Approved	Letter Label
Aug 8, 2002	Supplement 6Manufacturing · Standard review	Approved	None posted
May 10, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
May 3, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 16, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
May 26, 2000	Original applicationNew molecular entity · Standard review	Approved	Letter Label Review

Identifiers

Application: NDA 21176
Drugs@FDA: Overview at FDA
Company: Cosette

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters