FDA.reportPublic FDA data

Application 125320

Type
BLA
Sponsor
AMGEN

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125320Proliadenosumab351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROLIADENOSUMABINJECTABLE; SUBCUTANEOUS60MG/MLNoNo
002XGEVADENOSUMABINJECTABLE; SUBCUTANEOUS70MG/MLNoNo

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProliaDENOSUMABAmgen, Inc49e5afe9-a0c7-40c4-af9f-f287a80c5c882026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125320
ndc (product): 55513-710
XGEVADENOSUMABAmgen, Inc628f0998-1206-4001-aeee-18133aa9f3bf2026-06-23Warnings, Adverse reactionsExact identifier
application number: BLA125320
ndc (product): 55513-730

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-710ProliadenosumabAmgen IncBLACurrent
55513-710ProliadenosumabAmgen IncBLACurrent
55513-710ProliadenosumabAmgen IncBLACurrent
55513-710ProliadenosumabAmgen IncBLACurrent
55513-710ProliadenosumabAmgen IncBLACurrent
55513-710ProliadenosumabAmgen IncBLACurrent
55513-710ProliadenosumabAmgen IncBLACurrent
55513-710ProliadenosumabAmgen IncBLACurrent
55513-730XGEVAdenosumabAmgen IncBLACurrent
55513-730XGEVAdenosumabAmgen IncBLACurrent
55513-730XGEVAdenosumabAmgen IncBLACurrent
55513-730XGEVAdenosumabAmgen IncBLACurrent
55513-730XGEVAdenosumabAmgen IncBLACurrent
55513-730XGEVAdenosumabAmgen IncBLACurrent
55513-730XGEVAdenosumabAmgen IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82428SUPPL 2025-06-02
82421SUPPL 2025-06-02
82409SUPPL 2025-06-02
82408SUPPL 2025-06-02
82320SUPPL 2025-05-27
82158SUPPL 2025-05-05
82134SUPPL 2025-05-05
78107SUPPL 2024-04-10
77733SUPPL 2024-03-06
77715SUPPL 2024-03-05
77714SUPPL 2024-03-05
77265SUPPL 2024-01-22
77248SUPPL 2024-01-22
73100SUPPL2023-01-05
73099SUPPL2023-01-05
73081SUPPL2023-01-04
71109SUPPL2022-05-20
71107SUPPL2022-05-20
71106SUPPL2022-05-20
67483SUPPL2021-05-13
67482SUPPL2021-05-13
67478SUPPL2021-05-13
63568SUPPL2020-06-15
63477SUPPL2020-06-10
62673SUPPL2020-04-24
62669SUPPL2020-04-24
62668SUPPL2020-04-24
61863SUPPL2020-02-11
61862SUPPL2020-02-11
60215SUPPL2019-10-03
60189SUPPL2019-10-02
60188SUPPL2019-10-02
59496SUPPL2019-07-30
59480SUPPL2019-07-29
58953SUPPL2019-06-04
58870SUPPL2019-05-29
58690SUPPL2019-05-14
58689SUPPL2019-05-14
58644SUPPL2019-05-13
58643SUPPL2019-05-13
58511SUPPL2019-05-02
58500SUPPL2019-05-01
57220SUPPL2019-01-15
57219SUPPL2019-01-15
56508SUPPL2018-11-20
54564SUPPL2018-06-14
54496SUPPL2018-06-11
43320SUPPL2018-06-05
54285SUPPL2018-05-22
54278SUPPL2018-05-21
51909SUPPL2018-01-26
51905SUPPL2018-01-26
51006SUPPL2018-01-09
50980SUPPL2018-01-04
48569SUPPL2017-05-30
48571SUPPL2017-05-26
47075SUPPL2017-01-31
45538SUPPL2016-10-17
45537SUPPL2016-10-17
45039SUPPL2016-08-05
45031SUPPL2016-08-05
45026SUPPL2016-08-05
45025SUPPL2016-08-05
45024SUPPL2016-08-05
45023SUPPL2016-08-05
45014SUPPL2016-08-05
45013SUPPL2016-08-05
45011SUPPL2016-08-05
45010SUPPL2016-08-05
45009SUPPL2016-08-05
45008SUPPL2016-08-05
45007SUPPL2016-08-05
31930SUPPL2016-03-04
18871SUPPL2016-03-04
31929SUPPL2015-06-10
18870SUPPL2015-06-10
9707SUPPL2015-05-26
9709SUPPL2015-04-13
39929SUPPL2015-04-10
39928SUPPL2015-03-02
9708SUPPL2015-03-02
39927SUPPL2014-12-10
9706SUPPL2014-12-09
9704SUPPL2014-06-18
39926SUPPL2014-06-17
9705SUPPL2014-06-05
18869SUPPL2014-06-04
39925SUPPL2013-08-27
39924SUPPL2013-08-27
9703SUPPL2013-08-27
9702SUPPL2013-08-27
31928SUPPL2013-07-08
39923SUPPL2013-07-05
39922SUPPL2013-06-13
31927SUPPL2013-06-13
31925SUPPL2013-02-20
18867SUPPL2013-02-20
18865SUPPL2012-09-25
31923SUPPL2012-09-24
31926SUPPL2012-09-18