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Last Updated: November 16, 2019

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Details for New Drug Application (NDA): 021176

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NDA 021176 describes WELCHOL, which is a drug marketed by Daiichi Sankyo Inc and Daiichi Sankyo and is included in four NDAs. It is available from two suppliers. There are two patents protecting this drug and two Paragraph IV challenges. 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. Thirteen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.
Summary for 021176
Tradename:WELCHOL
Applicant:Daiichi Sankyo
Ingredient:colesevelam hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021176
Mechanism of ActionBile-acid Binding Activity
Medical Subject Heading (MeSH) Categories for 021176
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 Ohm Laboratories, Inc. 51660-996 51660-996-28 180 TABLET, FILM COATED in 1 BOTTLE (51660-996-28)
WELCHOL colesevelam hydrochloride TABLET;ORAL 021176 NDA Daiichi Sankyo Inc. 65597-701 65597-701-18 180 TABLET, FILM COATED in 1 BOTTLE (65597-701-18)
Paragraph IV (Patent) Challenges for 021176
Tradename Dosage Ingredient NDA Submissiondate
WELCHOL TABLET;ORAL colesevelam hydrochloride 021176 2009-07-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength625MG
Approval Date:May 26, 2000TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Oct 17, 2022Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021176

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000   Start Trial   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000   Start Trial   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000   Start Trial   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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