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Details for New Drug Application (NDA): 021141

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NDA 021141 describes WELCHOL, which is a drug marketed by Daiichi Sankyo and is included in three NDAs. It is available from four suppliers. There is one patent 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. Four suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.

Summary for NDA: 021141

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength375MG
Approval Date:May 26, 2000TE:RLD:No
SELECT DISTINCT m.Applicant, m.Tradename, m.Ingredient, m.Dosage, CONCAT(m.NDA,'-',m.Number) AS NDA, m.Approvaldate, p.patentnumber as Patentnumber, a.expiredate as arch_expiredate FROM master m JOIN master_archives a ON (m.NDA = a.NDA and m.Number = a.Number) JOIN patentdetails p ON (a.Patentnumber = p.Patentnumber) WHERE m.NDA = "021141" AND a.expiredate < CURDATE() ORDER BY RAND(104)
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