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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 021176

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NDA 021176 describes WELCHOL, which is a drug marketed by Cosette and is included in four NDAs. It is available from three suppliers. Additional details are available on the WELCHOL profile page.

The generic ingredient in WELCHOL 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 021176

Tradename:	WELCHOL
Applicant:	Cosette
Ingredient:	colesevelam hydrochloride
Patents:	0

Pharmacology for NDA: 021176

Mechanism of Action	Bile-acid Binding Activity

Medical Subject Heading (MeSH) Categories for 021176

Anticholesteremic Agents

Suppliers and Packaging for NDA: 021176

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176	NDA	Cosette Pharmaceuticals, Inc.	0713-0879	0713-0879-81	180 TABLET, FILM COATED in 1 BOTTLE (0713-0879-81)
WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176	NDA	Cosette Pharmaceuticals, Inc.	0713-0936	0713-0936-81	180 TABLET, FILM COATED in 1 BOTTLE (0713-0936-81)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	625MG
Approval Date:	May 26, 2000	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021176

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176-001	May 26, 2000	6,066,678*PED	⤷ Get Started Free
Cosette	WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176-001	May 26, 2000	5,607,669*PED	⤷ Get Started Free
Cosette	WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176-001	May 26, 2000	6,433,026*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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