FDA.reportPublic FDA data

Application 206143

Type
NDA
Sponsor
AMGEN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CORLANORIVABRADINE HYDROCHLORIDETABLET;ORALEQ 5MG BASEYesNo
002CORLANORIVABRADINE HYDROCHLORIDETABLET;ORALEQ 7.5MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-800CorlanorivabradineAmgen IncNDACurrent
55513-800CorlanorivabradineAmgen IncNDACurrent
55513-800CorlanorivabradineAmgen IncNDACurrent
55513-800CorlanorivabradineAmgen IncNDACurrent
55513-800CorlanorivabradineAmgen IncNDACurrent
55513-800CorlanorivabradineAmgen IncNDACurrent
55513-800CorlanorivabradineAmgen IncNDACurrent
55513-800CorlanorivabradineAmgen IncNDACurrent
55513-800CorlanorivabradineAmgen IncNDACurrent
55513-810CorlanorivabradineAmgen IncNDACurrent
55513-810CorlanorivabradineAmgen IncNDACurrent
55513-810CorlanorivabradineAmgen IncNDACurrent
55513-810CorlanorivabradineAmgen IncNDACurrent
55513-810CorlanorivabradineAmgen IncNDACurrent
55513-810CorlanorivabradineAmgen IncNDACurrent
55513-810CorlanorivabradineAmgen IncNDACurrent
55513-810CorlanorivabradineAmgen IncNDACurrent
55513-810CorlanorivabradineAmgen IncNDACurrent
70518-3309CorlanorivabradineREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68405SUPPL2021-08-18
68308SUPPL2021-08-06
68298SUPPL2021-08-05
58729SUPPL2019-05-15
58665SUPPL2019-05-14
58664SUPPL2019-05-13
46915SUPPL2017-01-19
46856SUPPL2017-01-19
46804SUPPL2017-01-11
23013ORIG2015-11-20
19706ORIG2015-04-16
10548ORIG2015-04-16
66845ORIG1900-01-01
66844ORIG1900-01-01
66843ORIG1900-01-01
66842ORIG1900-01-01
63927ORIG1900-01-01
63926ORIG1900-01-01