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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 022362


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NDA 022362 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 022362
Tradename:WELCHOL
Applicant:Cosette
Ingredient:colesevelam hydrochloride
Patents:0
Pharmacology for NDA: 022362
Mechanism of ActionBile-acid Binding Activity
Medical Subject Heading (MeSH) Categories for 022362
Suppliers and Packaging for NDA: 022362
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362 NDA Cosette Pharmaceuticals, Inc. 0713-0880 0713-0880-30 30 PACKET in 1 CARTON (0713-0880-30) / 1 FOR SUSPENSION in 1 PACKET
WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362 NDA Cosette Pharmaceuticals, Inc. 0713-0935 0713-0935-30 30 PACKET in 1 CARTON (0713-0935-30) / 1 FOR SUSPENSION in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrength1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 2, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 20, 2024
Regulatory Exclusivity Use:INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength3.75GM/PACKET
Approval Date:Oct 2, 2009TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Oct 20, 2024
Regulatory Exclusivity Use:INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES

Expired US Patents for NDA 022362

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cosette WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 ⤷  Sign Up ⤷  Sign Up
Cosette WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 ⤷  Sign Up ⤷  Sign Up
Cosette WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 ⤷  Sign Up ⤷  Sign Up
Cosette WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 ⤷  Sign Up ⤷  Sign Up
Cosette WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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