FDA.reportPublic FDA data

Application 206316

Type
NDA
Sponsor
DAIICHI SANKYO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SAVAYSAEDOXABAN TOSYLATETABLET;ORALEQ 15MG BASEYesNo
002SAVAYSAEDOXABAN TOSYLATETABLET;ORALEQ 30MG BASEYesNo
003SAVAYSAEDOXABAN TOSYLATETABLET;ORALEQ 60MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65597-201SAVAYSAEDOXABAN TOSYLATEDaiichi Sankyo Inc.NDACurrent
65597-201SAVAYSAEDOXABAN TOSYLATEDaiichi Sankyo Inc.NDACurrent
65597-201SAVAYSAEDOXABAN TOSYLATEDaiichi Sankyo Inc.NDACurrent
65597-201SAVAYSAEDOXABAN TOSYLATEDaiichi SankyoNDACurrent
65597-201SAVAYSAEDOXABAN TOSYLATEDaiichi Sankyo Inc.NDACurrent
65597-201SAVAYSAEDOXABAN TOSYLATEDaiichi Sankyo Inc.NDACurrent
65597-202SAVAYSAEDOXABAN TOSYLATEDaiichi Sankyo Inc.NDACurrent
65597-202SAVAYSAEDOXABAN TOSYLATEDaiichi Sankyo Inc.NDACurrent
65597-202SAVAYSAEDOXABAN TOSYLATEDaiichi SankyoNDACurrent
65597-202SAVAYSAEDOXABAN TOSYLATEDaiichi Sankyo Inc.NDACurrent
65597-202SAVAYSAEDOXABAN TOSYLATEDaiichi Sankyo Inc.NDACurrent
65597-202SAVAYSAEDOXABAN TOSYLATEDaiichi Sankyo Inc.NDACurrent
65597-203SAVAYSAEDOXABAN TOSYLATEDaiichi Sankyo Inc.NDACurrent
65597-203SAVAYSAEDOXABAN TOSYLATEDaiichi Sankyo Inc.NDACurrent
65597-203SAVAYSAEDOXABAN TOSYLATEDaiichi Sankyo Inc.NDACurrent
65597-203SAVAYSAEDOXABAN TOSYLATEDaiichi Sankyo Inc.NDACurrent
65597-203SAVAYSAEDOXABAN TOSYLATEDaiichi SankyoNDACurrent
65597-203SAVAYSAEDOXABAN TOSYLATEDaiichi Sankyo Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75865SUPPL 2023-10-19
75864SUPPL 2023-10-19
75846SUPPL 2023-10-19
75406SUPPL 2023-09-12
75393SUPPL 2023-09-12
69211SUPPL2021-11-02
69195SUPPL2021-11-02
67153SUPPL2021-04-22
67135SUPPL2021-04-22
62649SUPPL2020-04-23
62648SUPPL2020-04-23
62625SUPPL2020-04-22
59679SUPPL2019-08-13
59657SUPPL2019-08-12
59656SUPPL2019-08-12
49941SUPPL2017-10-04
49911SUPPL2017-10-02
49908SUPPL2017-10-02
45300SUPPL2016-09-20
45281SUPPL2016-09-19
10558SUPPL2015-09-14
40536SUPPL2015-09-11
44942ORIG2015-02-13
43514ORIG2015-02-13
43558ORIG2015-01-09
40535ORIG2015-01-09
32795ORIG2015-01-09
10557ORIG2015-01-09