darbepoetin alfa Injection

Brand(s)
Aranesp
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Amgen Inc (2015-07-15)
Oldest Current Product
2006-08-14
License(s)
BLA
RxNORM
INJECTION\DARBEPOETIN ALFA
SPL Active
INTRAVENOUS\SOLUTION\DARBEPOETIN ALFA
SPL Moiety
INTRAVENOUS\SOLUTION\DARBEPOETIN ALFA

product(s) by strength(s)

1 ml darbepoetin alfa 0.025 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555130002AranespBLAAmgen Inc2006-09-11DARBEPOETIN ALFAINTRAVENOUSSOLUTION1039510fd36cb9-c4f6-4167-93c9-8530865db3f9

1 ml darbepoetin alfa 0.04 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555130003AranespBLAAmgen Inc2006-09-11DARBEPOETIN ALFAINTRAVENOUSSOLUTION1039510fd36cb9-c4f6-4167-93c9-8530865db3f9

1 ml darbepoetin alfa 0.06 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555130004AranespBLAAmgen Inc2006-09-11DARBEPOETIN ALFAINTRAVENOUSSOLUTION1039510fd36cb9-c4f6-4167-93c9-8530865db3f9

1 ml darbepoetin alfa 0.1 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555130005AranespBLAAmgen Inc2006-09-11DARBEPOETIN ALFAINTRAVENOUSSOLUTION1039510fd36cb9-c4f6-4167-93c9-8530865db3f9

0.75 ml darbepoetin alfa 0.2 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555130053AranespBLAAmgen Inc2006-09-11DARBEPOETIN ALFAINTRAVENOUSSOLUTION1039510fd36cb9-c4f6-4167-93c9-8530865db3f9

1 ml darbepoetin alfa 0.2 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555130006AranespBLAAmgen Inc2006-09-11DARBEPOETIN ALFAINTRAVENOUSSOLUTION1039510fd36cb9-c4f6-4167-93c9-8530865db3f9

1 ml darbepoetin alfa 0.3 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555130110AranespBLAAmgen Inc2006-08-14DARBEPOETIN ALFAINTRAVENOUSSOLUTION1039510fd36cb9-c4f6-4167-93c9-8530865db3f9

application(s)

#idtitleapprovedtradenamesfda division
1103951darbepoetin alfa Application2001-09-17AranespCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10fd36cb9-c4f6-4167-93c9-8530865db3f9 (view SPL)These highlights do not include all the information needed to use ARANESP safely and effectively. See full prescribing information for ARANESP . ARANESP ( darbepoetin alfa ) i njection, for intravenous or subcutaneous use Initial U.S. Approval: 2001prescriptionHuman PrescriptionAmgen IncANALYSIS, MANUFACTURE2015-07-15138555130002, 555130003, 555130004, 555130005, 555130006, 555130053, 555130110, 555130021, 555130023, 555130025, 555130027, 555130028, 555130032, 555130057, 555130098, 555130111darbepoetin alfa Prefilled Syringe

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