FDA.reportPublic FDA data

Application 103951

Type
BLA
Sponsor
AMGEN

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103951Aranespdarbepoetin alpha351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARANESPDARBEPOETIN ALFAVIAL; INTRAVENOUS25UG/MLNoNo
002ARANESPDARBEPOETIN ALFAVIAL; INTRAVENOUS40UG/MLNoNo
003ARANESPDARBEPOETIN ALFAVIAL; INTRAVENOUS60UG/MLNoNo
004ARANESPDARBEPOETIN ALFAVIAL; INTRAVENOUS100UG/MLNoNo
005ARANESPDARBEPOETIN ALFAVIAL; INTRAVENOUS200UG/MLNoNo
006ARANESPDARBEPOETIN ALFAVIAL; SUBCUTANEOUS25UG/MLNoNo
007ARANESPDARBEPOETIN ALFAVIAL; SUBCUTANEOUS40UG/MLNoNo
008ARANESPDARBEPOETIN ALFAVIAL; SUBCUTANEOUS60UG/MLNoNo
009ARANESPDARBEPOETIN ALFAVIAL; SUBCUTANEOUS100UG/MLNoNo
010ARANESPDARBEPOETIN ALFAVIAL; SUBCUTANEOUS200UG/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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ARANESPDARBEPOETIN ALFAAmgen, Inc0fd36cb9-c4f6-4167-93c9-8530865db3f92026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103951
ndc (product): 55513-023
ndc (product): 55513-025
ndc (product): 55513-111
ndc (product): 55513-004
ndc (product): 55513-098
ndc (product): 55513-003
ndc (product): 55513-028
ndc (product): 55513-005
ndc (product): 55513-002
ndc (product): 55513-032
ndc (product): 55513-021
ndc (product): 55513-057
ndc (product): 55513-027
ndc (product): 55513-006

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-002ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-002ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-002ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-003ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-003ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-003ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-004ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-004ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-004ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-005ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-005ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-005ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-006ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-006ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-006ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-021ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-021ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-021ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-023ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-023ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-023ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-025ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-025ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-025ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-027ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-027ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-027ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-028ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-028ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-028ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-032ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-032ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-032ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-057ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-057ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-057ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-098ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-098ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-098ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-110ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-110ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-110ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-111ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-111ARANESPdarbepoetin alfaAmgen IncBLACurrent
55513-111ARANESPdarbepoetin alfaAmgen IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78338SUPPL 2024-05-02
78331SUPPL 2024-05-01
39760SUPPL2019-06-05
57583SUPPL2019-02-13
57388SUPPL2019-01-31
56981SUPPL2018-12-21
56980SUPPL2018-12-21
50308SUPPL2017-11-06
50247SUPPL2017-10-31
48043SUPPL2017-04-14
48014SUPPL2017-04-14
31742SUPPL2016-04-28
31741SUPPL2015-07-24
18710SUPPL2014-01-07
18709SUPPL2014-01-07
31739SUPPL2014-01-02
9517SUPPL2014-01-02
31740SUPPL2013-03-29
22765SUPPL2012-07-16
18708SUPPL2012-06-06
9516SUPPL2012-06-04
24355SUPPL2012-05-25
22764SUPPL2011-12-02
31738SUPPL2011-06-24
18707SUPPL2011-06-24
18705SUPPL2011-06-24
9515SUPPL2011-06-24
9514SUPPL2011-06-24
31735SUPPL2011-04-28
31736SUPPL2010-02-16
18706SUPPL2010-02-16
31737SUPPL2010-02-05
39758SUPPL2010-02-04
39757SUPPL2010-02-04
39756SUPPL2008-11-26
31734SUPPL2008-03-13
43576SUPPL2008-03-12
39755SUPPL2008-03-11
31733SUPPL2008-01-31
18704SUPPL2008-01-30
31732SUPPL2007-11-08
23082SUPPL2007-11-08
18703SUPPL2007-11-08
31730SUPPL2007-04-20
18701SUPPL2007-04-20
31731SUPPL2007-03-15
18702SUPPL2007-03-09
31729SUPPL2006-04-05
18700SUPPL2006-04-05
39754SUPPL2006-02-08
9512SUPPL2006-02-08
18699SUPPL2005-12-16
9513SUPPL2005-12-16
18698SUPPL2005-01-26
9511SUPPL2005-01-26
43575SUPPL2004-09-22
39753SUPPL2004-03-11
31728SUPPL2004-03-11
31727ORIG2004-01-21
22763ORIG2004-01-21
18697ORIG2004-01-21
52597SUPPL1900-01-01
52596SUPPL1900-01-01