Epoetin Alfa Injection

Brand(s)
Epogen, Procrit
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Amgen Inc (2014-06-27)
Oldest Current Product
1989-06-01
License(s)
BLA
RxNORM
INJECTION\EPOETIN ALFA
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\ERYTHROPOIETIN
INTRAVENOUS\SOLUTION\ERYTHROPOIETIN
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\ERYTHROPOIETIN
INTRAVENOUS\SOLUTION\ERYTHROPOIETIN

product(s) by strength(s)

1 ml epoetin alfa 10000 unt/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596760310ProcritBLAJanssen Products, Lp1989-06-01ERYTHROPOIETININTRAVENOUSINJECTION, SOLUTION1032340c721ba4-ae19-417f-aae1-221ed1a0866a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548682523ProcritBLAPhysicians Total Care, Inc.1994-08-11ERYTHROPOIETININTRAVENOUSINJECTION, SOLUTION5967603101032349bbe9a5b-ad1d-41a4-9699-ff6dc776bce1

1 ml epoetin alfa 2000 unt/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596760302ProcritBLAJanssen Products, Lp1989-06-01ERYTHROPOIETININTRAVENOUSINJECTION, SOLUTION1032340c721ba4-ae19-417f-aae1-221ed1a0866a

1 ml epoetin alfa 3000 unt/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555130267EpogenBLAAmgen Inc1990-04-30ERYTHROPOIETININTRAVENOUSSOLUTION1032341f2d0b28-9cc5-4523-80b8-637fdaf3f7a5

1 ml epoetin alfa 4000 unt/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596760304ProcritBLAJanssen Products, Lp1989-06-01ERYTHROPOIETININTRAVENOUSINJECTION, SOLUTION1032340c721ba4-ae19-417f-aae1-221ed1a0866a

1 ml epoetin alfa 40000 unt/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596760340ProcritBLAJanssen Products, Lp1989-06-01ERYTHROPOIETININTRAVENOUSINJECTION, SOLUTION1032340c721ba4-ae19-417f-aae1-221ed1a0866a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685802ProcritBLAPhysicians Total Care, Inc.2007-08-13ERYTHROPOIETININTRAVENOUSINJECTION, SOLUTION5967603401032349bbe9a5b-ad1d-41a4-9699-ff6dc776bce1

application(s)

#idtitleapprovedtradenamesfda division
1103234epoetin alfa Application1989-06-01Epogen/ProcritCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10c721ba4-ae19-417f-aae1-221ed1a0866a (view SPL)These highlights do not include all the information needed to use PROCRIT safely and effectively. See full prescribing information for PROCRIT. PROCRIT (epoetin alfa) injection, for intravenous or subcutaneous use Initial U.S. Approval: 1989prescriptionHuman PrescriptionJanssen Products, LpANALYSIS, MANUFACTURE2013-12-3121596760302, 596760304, 596760310, 596760340, 596760303, 596760312, 596760320Epoetin Alfa Injectable Solution
21f2d0b28-9cc5-4523-80b8-637fdaf3f7a5 (view SPL)These highlights do not include all the information needed to use Epogen safely and effectively. See full prescribing information for Epogen. Epogen (epoetin alfa)injection, for intravenous or subcutaneous useInitial U.S. Approval: 1989prescriptionHuman PrescriptionAmgen IncANALYSIS, MANUFACTURE2014-06-27121555130267, 555130126, 555130144, 555130148, 555130283, 555130478, 555130823Epoetin Alfa Injectable Solution
39bbe9a5b-ad1d-41a4-9699-ff6dc776bce1 (view SPL)These highlights do not include all the information needed to use PROCRIT safely and effectively. See full prescribing information for PROCRIT. PROCRIT (epoetin alfa) injection, for intravenous or subcutaneous use Initial U.S. Approval: 1989prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2013-01-172548682523, 548685802, 548685673Epoetin Alfa Injectable Solution

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII