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Last Updated: December 6, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210895

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NDA 210895 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 210895
Tradename:WELCHOL
Applicant:Daiichi Sankyo Inc
Ingredient:colesevelam hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 210895
Mechanism of ActionBile-acid Binding Activity
Medical Subject Heading (MeSH) Categories for 210895
Suppliers and Packaging for NDA: 210895
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
WELCHOL colesevelam hydrochloride BAR, CHEWABLE;ORAL 210895 NDA Daiichi Sankyo Inc. 65597-208 65597-208-30 30 PACKAGE in 1 CARTON (65597-208-30) > 1 BAR, CHEWABLE in 1 PACKAGE
WELCHOL colesevelam hydrochloride BAR, CHEWABLE;ORAL 210895 NDA Daiichi Sankyo Inc. 65597-209 65597-209-30 30 PACKAGE in 1 CARTON (65597-209-30) > 1 BAR, CHEWABLE in 1 PACKAGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:BAR, CHEWABLE;ORALStrength3.75GM
Approval Date:Apr 3, 2019TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 17, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD FOR REDUCING SERUM GLUCOSE LEVELS IN ADULTS WITH TYPE 2 DIABETES MELLITUS

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