FDA.reportPublic FDA data

Application 761062

Type
BLA
Sponsor
AMGEN INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761062Evenityromosozumab-aqqg351(a)Rx2026-07-01

Application Products#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EvenityROMOSOZUMAB-AQQGAmgen, Inc471baba2-7154-4488-9891-0db2f46791e72026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761062
ndc (product): 55513-880

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

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