← FDA DRUG APPROVALS

FDA BLA · BLA103951

ARANESP

darbepoetin alfa

Sponsor: AMGEN

APPLICATION
BLA103951
TYPE
BLA
ORIGINAL APPROVAL
2001-09-17
LATEST ACTION
2024-04-30
ROUTE
INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

ARANESPPrescription
DARBEPOETIN ALFA 100UG/ML · VIAL · SUBCUTANEOUS
ARANESPPrescription
DARBEPOETIN ALFA 40UG/ML · VIAL · SUBCUTANEOUS
ARANESPPrescription
DARBEPOETIN ALFA 200UG/ML · VIAL · INTRAVENOUS
ARANESPPrescription
DARBEPOETIN ALFA 60UG/ML · VIAL · INTRAVENOUS
ARANESPPrescription
DARBEPOETIN ALFA 25UG/ML · VIAL · INTRAVENOUS
ARANESPPrescription
DARBEPOETIN ALFA 60UG/ML · VIAL · SUBCUTANEOUS
ARANESPPrescription
DARBEPOETIN ALFA 25UG/ML · VIAL · SUBCUTANEOUS
ARANESPPrescription
DARBEPOETIN ALFA 100UG/ML · VIAL · INTRAVENOUS
ARANESPPrescription
DARBEPOETIN ALFA 200UG/ML · VIAL · SUBCUTANEOUS
ARANESPPrescription
DARBEPOETIN ALFA 40UG/ML · VIAL · INTRAVENOUS

Approval history

2024-04-30Labeling · Supplement 5383 · standard — Letter ↗AP
2019-01-30Efficacy · Supplement 5378 · priority — Label ↗AP
2018-12-20Labeling · Supplement 5377 · standard — Label ↗AP
2017-10-31Labeling · Supplement 5374 · standard — Label ↗AP
2017-04-13Labeling · Supplement 5375 · standard — Label ↗AP
2016-04-27Labeling · Supplement 5370 · standard — Letter ↗AP
2015-07-23Efficacy · Supplement 5363 · standard — Label ↗AP
2014-04-17Labeling · Supplement 5353AP
2013-12-31Labeling · Supplement 5349 · standard — Letter ↗AP
2013-12-31Labeling · Supplement 5325 · standard — Label ↗AP
2013-03-27Labeling · Supplement 5337 · standard — Letter ↗AP
2012-05-31Labeling · Supplement 5285 · standard — Letter ↗AP
2011-06-24Labeling · Supplement 5258 · standard — Letter ↗AP
2011-06-24Labeling · Supplement 5248 · standard — Letter ↗AP
2011-06-24Efficacy · Supplement 5173 · standard — Letter ↗AP
2010-02-16Labeling · Supplement 5197 · standard — Label ↗AP
2010-01-11Labeling · Supplement 5223 · standard — Label ↗AP
2009-10-13Labeling · Supplement 5211 · standard — Label ↗AP
2008-11-19Labeling · Supplement 5195 · standard — Label ↗AP
2008-05-05Efficacy · Supplement 5111 · standardAP
2008-03-07Labeling · Supplement 5170 · standard — Label ↗AP
2007-12-17Labeling · Supplement 5169 · standard — Label ↗AP
2007-11-13Labeling · Supplement 5154 · standardAP
2007-11-08Labeling · Supplement 5164 · standard — Label ↗AP
2007-04-10Labeling · Supplement 5135 · standard — Label ↗AP
2007-03-09Labeling · Supplement 5139 · standard — Label ↗AP
2006-03-23Efficacy · Supplement 5097 · standard — Label ↗AP
2005-12-15Efficacy · Supplement 5088 · standard — Label ↗AP
2005-10-26Labeling · Supplement 5096 · standard — Letter ↗AP
2005-03-24Labeling · Supplement 5090 · standardAP
2004-12-16Labeling · Supplement 5069 · standard — Letter ↗AP
2004-11-18Labeling · Supplement 5075 · standardAP
2002-07-19Efficacy · Supplement 5001 · standard — Label ↗AP
2001-09-17Type 1 - New Molecular Entity · Original · standard — Label ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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