FDA.reportPublic FDA data

Application 209964

Type
NDA
Sponsor
AMGEN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CORLANORIVABRADINESOLUTION;ORAL5MG/5ML (1MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-813CorlanorivabradineAmgen IncNDACurrent
55513-813CorlanorivabradineAmgen IncNDACurrent
55513-813CorlanorivabradineAmgen IncNDACurrent
55513-813CorlanorivabradineAmgen IncNDACurrent
55513-813CorlanorivabradineAmgen IncNDACurrent
55513-813CorlanorivabradineAmgen IncNDACurrent
55513-813CorlanorivabradineAmgen IncNDACurrent
55513-813CorlanorivabradineAmgen IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68406SUPPL2021-08-18
68309SUPPL2021-08-06
68299SUPPL2021-08-05
60827ORIG2019-11-13
58373ORIG2019-04-24
58363ORIG2019-04-22
58362ORIG2019-04-22
63083ORIG1900-01-01
63082ORIG1900-01-01
63081ORIG1900-01-01