FDA.reportPublic FDA data

Application 022362

Type
NDA
Sponsor
DAIICHI SANKYO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001WELCHOLCOLESEVELAM HYDROCHLORIDEFOR SUSPENSION;ORAL1.875GM/PACKETYesNo
002WELCHOLCOLESEVELAM HYDROCHLORIDEFOR SUSPENSION;ORAL3.75GM/PACKETYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0880Welcholcolesevelam hydrochlorideCosette Pharmaceuticals, Inc.NDACurrent
0713-0880Welcholcolesevelam hydrochlorideCosette Pharmaceuticals, Inc.NDACurrent
0713-0935COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDECosette Pharmaceuticals, Inc.NDACurrent
0713-0935COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDECosette Pharmaceuticals, Inc.NDACurrent
0713-0935COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDECosette Pharmaceuticals, Inc.NDACurrent
21695-779Welcholcolesevelam hydrochlorideRebel Distributors CorpNDACurrent
51660-995Colesevelam hydrochloridecolesevelam hydrochlorideOhm Laboratories, Inc.NDACurrent
51660-995Colesevelam hydrochloridecolesevelam hydrochlorideOhm Laboratories, Inc.NDACurrent
51660-995Colesevelam hydrochloridecolesevelam hydrochlorideOhm Laboratories, Inc.NDACurrent
51660-995Colesevelam hydrochloridecolesevelam hydrochlorideOhm Laboratories, Inc.NDACurrent
51660-995Colesevelam hydrochloridecolesevelam hydrochlorideOhm Laboratories, Inc.NDACurrent
65597-902Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-902Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-902Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-902Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-902Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-902Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-902Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-902Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-903Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-903Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-903Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-903Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69060SUPPL2021-10-21
69051SUPPL2021-10-21
64146SUPPL2020-07-30
64134SUPPL2020-07-30
62962SUPPL2020-05-13
62956SUPPL2020-05-13
58838SUPPL2019-05-23
58831SUPPL2019-05-22
58494SUPPL2019-05-01
58290SUPPL2019-04-11
57310SUPPL2019-01-22
57242SUPPL2019-01-17
29652SUPPL2014-01-23
17294SUPPL2014-01-23
38623SUPPL2013-07-02
38622SUPPL2013-07-02
38621SUPPL2013-07-02
29651SUPPL2013-07-02
29650SUPPL2013-07-02
29649SUPPL2013-07-02
38620SUPPL2012-07-13
29648SUPPL2012-07-13
29647SUPPL2012-01-17
17293SUPPL2012-01-06
29646SUPPL2011-07-19
17292SUPPL2011-07-18
38619SUPPL2010-09-20
29645SUPPL2010-09-16
42499ORIG2010-03-31
24289ORIG2010-03-31
7294ORIG2009-10-26
17291ORIG2009-10-07
51493ORIG2007-04-02
51490ORIG2006-03-28
51487ORIG2006-01-19
51485ORIG2004-08-31