FDA.reportPublic FDA data

Application 210895

Type
NDA
Sponsor
DAIICHI SANKYO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001WELCHOLCOLESEVELAM HYDROCHLORIDEBAR, CHEWABLE;ORAL3.75GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65597-208Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-208Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-208Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-209Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-209Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-209Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-210Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-210Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-210Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62963SUPPL2020-05-13
62958SUPPL2020-05-13
59903ORIG2019-09-03
58200ORIG2019-09-03
58211ORIG2019-04-04
64997ORIG1900-01-01
64996ORIG1900-01-01
62921ORIG1900-01-01