FDA.reportPublic FDA data

Application 021176

Type
NDA
Sponsor
DAIICHI SANKYO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001WELCHOLCOLESEVELAM HYDROCHLORIDETABLET;ORAL625MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0879Welcholcolesevelam hydrochlorideCosette Pharmaceuticals, Inc.NDACurrent
0713-0879Welcholcolesevelam hydrochlorideCosette Pharmaceuticals, Inc.NDACurrent
0713-0936COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDECosette Pharmaceuticals, Inc.NDACurrent
0713-0936COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDECosette Pharmaceuticals, Inc.NDACurrent
0713-0936COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDECosette Pharmaceuticals, Inc.NDACurrent
21695-781Welcholcolesevelam hydrochlorideRebel Distributors CorpNDACurrent
51660-996Colesevelam hydrochloridecolesevelam hydrochlorideOhm Laboratories, Inc.NDACurrent
51660-996Colesevelam hydrochloridecolesevelam hydrochlorideOhm Laboratories, Inc.NDACurrent
51660-996Colesevelam hydrochloridecolesevelam hydrochlorideOhm Laboratories, Inc.NDACurrent
51660-996Colesevelam hydrochloridecolesevelam hydrochlorideOhm Laboratories, Inc.NDACurrent
51660-996Colesevelam hydrochloridecolesevelam hydrochlorideOhm Laboratories, Inc.NDACurrent
65597-701Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-701Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-701Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-701Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-701Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-701Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-701Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-701Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
68151-4362Welcholcolesevelam hydrochlorideCarilion Materials ManagementNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69064SUPPL2021-10-21
69052SUPPL2021-10-21
64147SUPPL2020-07-30
64135SUPPL2020-07-30
62961SUPPL2020-05-13
62957SUPPL2020-05-13
58830SUPPL2019-05-22
58837SUPPL2019-05-16
57309SUPPL2019-01-22
57241SUPPL2019-01-17
36290SUPPL2014-01-23
4563SUPPL2014-01-23
36291SUPPL2013-07-02
26997SUPPL2013-07-02
14578SUPPL2013-07-02
4564SUPPL2013-07-02
14577SUPPL2012-07-13
4562SUPPL2012-07-13
4561SUPPL2012-01-17
36289SUPPL2012-01-06
26996SUPPL2011-07-19
36288SUPPL2011-07-18
14576SUPPL2010-09-20
4560SUPPL2010-09-16
4559SUPPL2009-10-26
14575SUPPL2009-10-07
4558SUPPL2008-06-06
36287SUPPL2008-01-23
4557SUPPL2008-01-23
26995SUPPL2007-08-30
14574SUPPL2007-08-30
51501SUPPL2007-04-02
4556SUPPL2006-09-18
36285SUPPL2006-09-12
36286SUPPL2006-07-13
26994SUPPL2006-07-13
51489SUPPL2006-03-28
51486SUPPL2006-01-19
51484SUPPL2004-08-31
36281ORIG2004-06-30
26992SUPPL2004-06-30
4552ORIG2004-06-30
36284SUPPL2003-12-02
4555SUPPL2003-11-25
14573SUPPL2003-10-16
4554SUPPL2003-10-16
36283SUPPL2003-08-28
26993SUPPL2003-08-28
14572SUPPL2003-03-05
36282SUPPL2002-10-17
4553SUPPL2002-10-17
42002ORIG2002-04-11
54046SUPPL1900-01-01
53224SUPPL1900-01-01
53223SUPPL1900-01-01