colesevelam Oral Tablet

Brand(s)
Welchol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Daiichi Sankyo (2014-01-30)
Oldest Current Product
2000-09-01
License(s)
NDA
RxNORM
ORAL TABLET\COLESEVELAM
FDAOB
ORAL\TABLET\COLESEVELAM HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\COLESEVELAM HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\COLESEVELAM

product(s) by strength(s)

colesevelam hydrochloride 625 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1655970701WelcholNDADaiichi Sankyo2000-09-01COLESEVELAM HYDROCHLORIDEORALTABLET, FILM COATEDNDA0211764a06d3b2-7229-4398-baba-5d0a72f63821

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950781WelcholNDARebel Distributors Corp2000-09-01COLESEVELAM HYDROCHLORIDEORALTABLET, FILM COATED655970701NDA021176fc274f83-4cd6-47bd-b43e-53a0bf345f11
2548684474WelcholNDAPhysicians Total Care, Inc.2002-04-17COLESEVELAM HYDROCHLORIDEORALTABLET, FILM COATED655970701NDA021176b9df447c-b65b-45b9-873a-07a2ab6e2d1f
3681514362WelcholNDACarilion Materials Management2000-09-01COLESEVELAM HYDROCHLORIDEORALTABLET, FILM COATED655970701NDA021176725dd631-75be-4e9b-82d8-d2c8dfcb917b

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021176WELCHOLDAIICHI SANKYO INC2000-05-26p7229613, TREATMENT OF TYPE 2 DIABETES MELLITUS
p5693675
NDA021176_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021176_001RXCOLESEVELAM HYDROCHLORIDE (625MG)ORALTABLETTrue2000-05-26WELCHOL

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5693675 (view patent)2014-12-02NDA021176, NDA021141, NDA022362colesevelam Oral Suspension
2p7229613 (view patent)2022-04-17NDA021176, NDA022362colesevelam Oral Suspension

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
14a06d3b2-7229-4398-baba-5d0a72f63821 (view SPL)These highlights do not include all the information needed to use WELCHOL safely and effectively. See full prescribing information for WELCHOL. WELCHOL (colesevelam hydrochloride) Initial U.S. Approval: 2000prescriptionHuman PrescriptionDaiichi SankyoANALYSIS, MANUFACTURE, PACK2014-01-3017655970701, 655970902, 655970903colesevelam Oral Suspension
2725dd631-75be-4e9b-82d8-d2c8dfcb917b (view SPL)These highlights do not include all the information needed to use WELCHOL safely and effectively. See full prescribing information for WELCHOL. WELCHOL (colesevelam hydrochloride) Initial U.S. Approval: 2000prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2014-01-302681514362
3b9df447c-b65b-45b9-873a-07a2ab6e2d1f (view SPL)These highlights do not include all the information needed to use Welchol safely and effectively. See full prescribing information for Welchol. Welchol (colesevelam hydrochloride) Tablet, Film Coated, for Oral Welchol (colesevelam hydrochloride) For Suspension, for Oral Initial U.S. Approval: 2000prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-02-132548684474, 548686136colesevelam Oral Suspension
4fc274f83-4cd6-47bd-b43e-53a0bf345f11 (view SPL)These highlights do not include all the information needed to use Welchol safely and effectively. See full prescribing information for Welchol. Welchol (colesevelam hydrochloride) Tablet, Film Coated, for Oral Welchol (colesevelam hydrochloride) For Suspension, for Oral Initial U.S. Approval: 2000prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-261216950781, 216950779colesevelam Oral Suspension

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII