FDA.reportPublic FDA data

Application 103234

Type
BLA
Sponsor
AMGEN

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103234Epogen/Procritepoetin alfa351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPOGEN/PROCRITEPOETIN ALFAVIAL; SINGLE-USE10,000U/MLNoNo
002EPOGEN/PROCRITEPOETIN ALFAVIAL; MULTIDOSE20,000U/2MLNoNo
003EPOGEN/PROCRITEPOETIN ALFAVIAL; MULTIDOSE20,000/MLNoNo
004EPOGEN/PROCRITEPOETIN ALFAVIAL; SINGLE-USE2,000U/MLNoNo
005EPOGEN/PROCRITEPOETIN ALFAVIAL; SINGLE-USE3,000U/MLNoNo
006EPOGEN/PROCRITEPOETIN ALFAVIAL; SINGLE-USE40,000U/MLNoNo
007EPOGEN/PROCRITEPOETIN ALFAVIAL; SINGLE-USE4,000U/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
EPOGENEPOETIN ALFAAmgen, Inc1f2d0b28-9cc5-4523-80b8-637fdaf3f7a52026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103234
ndc (product): 55513-144
ndc (product): 55513-148
ndc (product): 55513-283
ndc (product): 55513-126
ndc (product): 55513-267
ndc (product): 55513-478
PROCRITERYTHROPOIETINJanssen Products, LP0c721ba4-ae19-417f-aae1-221ed1a0866a2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103234
ndc (product): 59676-312
ndc (product): 59676-303
ndc (product): 59676-302
ndc (product): 59676-310
ndc (product): 59676-320
ndc (product): 59676-340
ndc (product): 59676-304

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-126EPOGENepoetin alfaAmgen IncBLACurrent
55513-126EPOGENepoetin alfaAmgen IncBLACurrent
55513-126EPOGENepoetin alfaAmgen IncBLACurrent
55513-144EPOGENepoetin alfaAmgen IncBLACurrent
55513-144EPOGENepoetin alfaAmgen IncBLACurrent
55513-144EPOGENepoetin alfaAmgen IncBLACurrent
55513-148EPOGENepoetin alfaAmgen IncBLACurrent
55513-148EPOGENepoetin alfaAmgen IncBLACurrent
55513-148EPOGENepoetin alfaAmgen IncBLACurrent
55513-267EPOGENepoetin alfaAmgen IncBLACurrent
55513-267EPOGENepoetin alfaAmgen IncBLACurrent
55513-267EPOGENepoetin alfaAmgen IncBLACurrent
55513-283EPOGENepoetin alfaAmgen IncBLACurrent
55513-283EPOGENepoetin alfaAmgen IncBLACurrent
55513-283EPOGENepoetin alfaAmgen IncBLACurrent
55513-478EPOGENepoetin alfaAmgen IncBLACurrent
55513-478EPOGENepoetin alfaAmgen IncBLACurrent
55513-478EPOGENepoetin alfaAmgen IncBLACurrent
59676-302PROCRITErythropoietinJanssen Products, LPBLACurrent
59676-302PROCRITErythropoietinJanssen Products, LPBLACurrent
59676-303PROCRITErythropoietinJanssen Products, LPBLACurrent
59676-303PROCRITErythropoietinJanssen Products, LPBLACurrent
59676-304PROCRITErythropoietinJanssen Products, LPBLACurrent
59676-304PROCRITErythropoietinJanssen Products, LPBLACurrent
59676-310PROCRITErythropoietinJanssen Products, LPBLACurrent
59676-310PROCRITErythropoietinJanssen Products, LPBLACurrent
59676-312PROCRITErythropoietinJanssen Products, LPBLACurrent
59676-312PROCRITErythropoietinJanssen Products, LPBLACurrent
59676-320PROCRITErythropoietinJanssen Products, LPBLACurrent
59676-320PROCRITErythropoietinJanssen Products, LPBLACurrent
59676-340PROCRITErythropoietinJanssen Products, LPBLACurrent
59676-340PROCRITErythropoietinJanssen Products, LPBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78337SUPPL 2024-05-02
78333SUPPL 2024-05-01
78332SUPPL 2024-05-01
57153SUPPL2019-01-09
55002SUPPL2018-07-26
49942SUPPL2017-10-04
49922SUPPL2017-10-03
49921SUPPL2017-10-03
49910SUPPL2017-10-02
49909SUPPL2017-10-02
48042SUPPL2017-04-14
48041SUPPL2017-04-14
48017SUPPL2017-04-14
48016SUPPL2017-04-14
39644SUPPL2014-01-07
31576SUPPL2014-01-02
31577SUPPL2013-03-29
43267SUPPL2012-07-16
31575SUPPL2012-06-07
18571SUPPL2012-06-06
24353SUPPL2012-05-25
39643SUPPL2011-06-24
39638SUPPL2011-06-24
31574SUPPL2011-06-24
31573SUPPL2011-06-24
31572SUPPL2011-06-24
9376SUPPL2011-04-28
9375SUPPL2011-04-28
39641SUPPL2010-02-16
9377SUPPL2010-02-16
24078ORIG2010-02-05
24077ORIG2010-02-05
9378SUPPL2010-02-05
39642SUPPL2010-02-04
18570SUPPL2010-02-04
39640SUPPL2008-11-25
39639SUPPL2008-11-25
23079SUPPL2008-03-12
18569SUPPL2008-03-11
31571SUPPL2008-01-31
39637SUPPL2008-01-30
31570SUPPL2007-11-08
23078SUPPL2007-11-08
18568SUPPL2007-11-08
43266SUPPL2007-09-26
43265SUPPL2007-09-26
43264SUPPL2007-09-26
22733SUPPL2007-09-26
18563SUPPL2007-06-04
31564SUPPL2007-03-23
22732SUPPL2007-03-23
18564SUPPL2007-03-23
9374SUPPL2007-03-15
18567SUPPL2007-03-09
31569SUPPL2006-05-18
18566SUPPL2006-05-18
39636SUPPL2005-12-16
31568SUPPL2005-12-16
31567SUPPL2005-01-26
18565SUPPL2005-01-26
39635SUPPL2004-07-14
31566SUPPL2004-07-07
31565SUPPL2004-05-21