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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 209038

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NDA 209038 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 209038

Tradename:	COLESEVELAM HYDROCHLORIDE
Applicant:	Alkem Labs Ltd
Ingredient:	colesevelam hydrochloride
Patents:	0

Pharmacology for NDA: 209038

Mechanism of Action	Bile-acid Binding Activity

Medical Subject Heading (MeSH) Categories for 209038

Anticholesteremic Agents

Suppliers and Packaging for NDA: 209038

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	209038	ANDA	A-S Medication Solutions	50090-4371	50090-4371-0	90 TABLET, FILM COATED in 1 BOTTLE (50090-4371-0)
COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	209038	ANDA	Bryant Ranch Prepack	63629-8767	63629-8767-1	180 TABLET, FILM COATED in 1 BOTTLE (63629-8767-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	625MG
Approval Date:	Oct 5, 2018	TE:	AB	RLD:	No

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