FDA.reportPublic FDA data

Application 761062

Type
BLA
Sponsor
AMGEN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EVENITYROMOSOZUMAB-AQQGINJECTABLE;INJECTION105MG/1.17MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-880Evenityromosozumab-aqqgAmgen IncBLACurrent
55513-880Evenityromosozumab-aqqgAmgen IncBLACurrent
55513-880Evenityromosozumab-aqqgAmgen IncBLACurrent
55513-880Evenityromosozumab-aqqgAmgen IncBLACurrent
55513-880Evenityromosozumab-aqqgAmgen IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61449SUPPL2019-12-26
61415SUPPL2019-12-23
58738ORIG2019-05-16
58285ORIG2019-04-10
58266ORIG2019-04-09
58265ORIG2019-04-09