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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 207765

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NDA 207765 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 207765

Tradename:	COLESEVELAM HYDROCHLORIDE
Applicant:	Zydus Pharms
Ingredient:	colesevelam hydrochloride
Patents:	0

Pharmacology for NDA: 207765

Mechanism of Action	Bile-acid Binding Activity

Medical Subject Heading (MeSH) Categories for 207765

Anticholesteremic Agents

Suppliers and Packaging for NDA: 207765

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	207765	ANDA	Zydus Pharmaceuticals USA Inc.	68382-619	68382-619-10	1000 TABLET, FILM COATED in 1 BOTTLE (68382-619-10)
COLESEVELAM HYDROCHLORIDE	colesevelam hydrochloride	TABLET;ORAL	207765	ANDA	Zydus Pharmaceuticals USA Inc.	68382-619	68382-619-28	180 TABLET, FILM COATED in 1 BOTTLE (68382-619-28)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	625MG
Approval Date:	Oct 7, 2019	TE:	AB	RLD:	No

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