FDA.report

Application 103234

Type
BLA
Sponsor
AMGEN

Related Records

Application Products

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

NDC Listings For This Application

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

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