Last Updated: September 24, 2026

Details for New Drug Application (NDA): 213456

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NDA 213456 describes COLESEVELAM HYDROCHLORIDE, which is a drug marketed by Alkem Labs Ltd, Glenmark Pharms Ltd, Impax, Watson Labs Inc, Beijing Tide Pharm, Bionpharma, Chartwell Rx, Dr Reddys, Impax Labs Inc, Invagen Pharms, Inventia, Macleods Pharms, United Res Labs, Zhejiang Jingxin, and Zydus Pharms, and is included in eighteen NDAs. It is available from fifteen suppliers. Additional details are available on the COLESEVELAM HYDROCHLORIDE profile page.

The generic ingredient in COLESEVELAM HYDROCHLORIDE is colesevelam hydrochloride. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.

Summary for 213456

Tradename:	COLESEVELAM HYDROCHLORIDE
Applicant:	United Res Labs
Ingredient:	colesevelam hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 213456

Anticholesteremic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	625MG
Approval Date:	Jan 21, 2022	TE:		RLD:	No

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