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Last Updated: November 2, 2024

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. 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 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 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:RXDosage:TABLET;ORALStrength625MG
Approval Date:May 26, 2000TE:ABRLD:Yes

Expired US Patents for NDA 021176

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cosette WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 ⤷  Sign Up ⤷  Sign Up
Cosette WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 ⤷  Sign Up ⤷  Sign Up
Cosette WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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