Details for New Drug Application (NDA): 021176

✉ Email this page to a colleague

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. Sixteen 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

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176-001	May 26, 2000	7,101,960*PED	⤷ Subscribe
Cosette	WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176-001	May 26, 2000	5,917,007*PED	⤷ Subscribe
Cosette	WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176-001	May 26, 2000	6,784,254*PED	⤷ Subscribe
Cosette	WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176-001	May 26, 2000	5,607,669*PED	⤷ Subscribe
Cosette	WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176-001	May 26, 2000	6,066,678*PED	⤷ Subscribe
Cosette	WELCHOL	colesevelam hydrochloride	TABLET;ORAL	021176-001	May 26, 2000	7,229,613*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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. 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.