You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 19, 2025

Details for New Drug Application (NDA): 204893

✉ Email this page to a colleague

« Back to Dashboard

NDA 204893 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 Ltd, United Res Labs, Zhejiang Jingxin, and Zydus Pharms, and is included in eighteen NDAs. It is available from sixteen suppliers. Additional details are available on the COLESEVELAM HYDROCHLORIDE profile page.

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

Summary for 204893

Tradename:	COLESEVELAM HYDROCHLORIDE
Applicant:	Macleods Pharms Ltd
Ingredient:	colesevelam hydrochloride
Patents:	0

Pharmacology for NDA: 204893

Mechanism of Action	Bile-acid Binding Activity

Medical Subject Heading (MeSH) Categories for 204893

Anticholesteremic Agents

Suppliers and Packaging for NDA: 204893

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	204893	ANDA	Macleods Pharmaceuticals Limited	33342-197	33342-197-57	180 TABLET, FILM COATED in 1 BOTTLE (33342-197-57)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	625MG
Approval Date:	Apr 18, 2025	TE:		RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.