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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 208670

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NDA 208670 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 fifteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.

Summary for 208670

Tradename:	COLESEVELAM HYDROCHLORIDE
Applicant:	Bionpharma
Ingredient:	colesevelam hydrochloride
Patents:	0

Pharmacology for NDA: 208670

Mechanism of Action	Bile-acid Binding Activity

Medical Subject Heading (MeSH) Categories for 208670

Anticholesteremic Agents

Suppliers and Packaging for NDA: 208670

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	208670	ANDA	Bionpharma Inc.	69452-158	69452-158-25	180 TABLET, FILM COATED in 1 BOTTLE (69452-158-25)
COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	208670	ANDA	Bionpharma Inc.	69452-493	69452-493-25	180 TABLET in 1 BOTTLE (69452-493-25)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	625MG
Approval Date:	Sep 13, 2019	TE:	AB	RLD:	No

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