Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103951
Company: AMGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARANESP DARBEPOETIN ALFA 25UG/ML VIAL; INTRAVENOUS Prescription None No No
ARANESP DARBEPOETIN ALFA 40UG/ML VIAL; INTRAVENOUS Prescription None No No
ARANESP DARBEPOETIN ALFA 60UG/ML VIAL; INTRAVENOUS Prescription None No No
ARANESP DARBEPOETIN ALFA 100UG/ML VIAL; INTRAVENOUS Prescription None No No
ARANESP DARBEPOETIN ALFA 200UG/ML VIAL; INTRAVENOUS Prescription None No No
ARANESP DARBEPOETIN ALFA 25UG/ML VIAL; SUBCUTANEOUS Prescription None No No
ARANESP DARBEPOETIN ALFA 40UG/ML VIAL; SUBCUTANEOUS Prescription None No No
ARANESP DARBEPOETIN ALFA 60UG/ML VIAL; SUBCUTANEOUS Prescription None No No
ARANESP DARBEPOETIN ALFA 100UG/ML VIAL; SUBCUTANEOUS Prescription None No No
ARANESP DARBEPOETIN ALFA 200UG/ML VIAL; SUBCUTANEOUS Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/17/2001 ORIG-1 Approval N/A Label
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/darbamg091701LB.htm https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/darbamg091701L.htm https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080442.htm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/13/2017 SUPPL-5375 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103951s5375lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103951Orig1s5375ltr.pdf
10/31/2017 SUPPL-5374 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103951s5374lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103951Orig1s5374ltr.pdf
04/27/2016 SUPPL-5370 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103951Orig1s5370ltr.pdf
07/23/2015 SUPPL-5363 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103951s5363lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103951Orig1s5363ltr.pdf
04/17/2014 SUPPL-5353 Supplement

Label is not available on this site.

12/31/2013 SUPPL-5349 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103951s5349lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103951Orig1s5349ltr.pdf
03/27/2013 SUPPL-5337 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103951Orig1s5337ltr.pdf
12/31/2013 SUPPL-5325 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103951s5325lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103951Orig1s5325ltr.pdf
05/31/2012 SUPPL-5285 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103951s5285lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103951s5285ltr.pdf
06/24/2011 SUPPL-5258 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103951Orig1s5173_103951Orig1s5258lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103951Orig1s5173,103951Orig1s5258ltr.pdf
06/24/2011 SUPPL-5248 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103951s5248,103234s5256ltr.pdf
01/11/2010 SUPPL-5223 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103951s5223LBL.pdf
10/13/2009 SUPPL-5211 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103951s5211Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103951s5211ltr.pdf
02/16/2010 SUPPL-5197 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103951s5197lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103951s5197ltr.pdf
11/19/2008 SUPPL-5195 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103951s5195PI.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103951s5195ltr.pdf
06/24/2011 SUPPL-5173 Supplement Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103951Orig1s5173_103951Orig1s5258lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103951Orig1s5173,103951Orig1s5258ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/103951_aranesp_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103951Orig1s5173SumR.pdf
03/07/2008 SUPPL-5170 Supplement Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103951s5170lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103951s5170ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103951s5170ppi.pdf
12/17/2007 SUPPL-5169 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5169lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103951s5169ltr.pdf
11/08/2007 SUPPL-5164 Supplement Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5164lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103951s5164ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5164ppi.pdf
11/13/2007 SUPPL-5154 Supplement

Label is not available on this site.

03/09/2007 SUPPL-5139 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5139lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103951s5139ltr.pdf
04/10/2007 SUPPL-5135 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5135LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103951s5135ltr .pdf
05/05/2008 SUPPL-5111 Supplement

Label is not available on this site.

03/23/2006 SUPPL-5097 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103951s5097LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103951s5097ltr.pdf
10/26/2005 SUPPL-5096 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103951s5096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103951s5096ltr.pdf
03/24/2005 SUPPL-5090 Supplement

Label is not available on this site.

12/15/2005 SUPPL-5088 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103951s5088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103951s5088ltr.pdf
11/18/2004 SUPPL-5075 Supplement

Label is not available on this site.

12/16/2004 SUPPL-5069 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103951_5069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103951_5069ltr.pdf
07/19/2002 SUPPL-5001 Supplement Label (PDF)
Letter
Patient Package Insert (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/darbamg071902LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/darbamg071902L.htm https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/darbamg071902LB2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2002/103951Orig1s5001.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/31/2017 SUPPL-5374 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103951s5374lbl.pdf
10/31/2017 SUPPL-5374 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103951s5374lbl.pdf
04/13/2017 SUPPL-5375 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103951s5375lbl.pdf
04/13/2017 SUPPL-5375 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103951s5375lbl.pdf
04/13/2017 SUPPL-5375 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103951s5375lbl.pdf
07/23/2015 SUPPL-5363 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103951s5363lbl.pdf
12/31/2013 SUPPL-5349 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103951s5349lbl.pdf
12/31/2013 SUPPL-5325 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103951s5325lbl.pdf
05/31/2012 SUPPL-5285 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103951s5285lbl.pdf
06/24/2011 SUPPL-5258 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103951Orig1s5173_103951Orig1s5258lbl.pdf
06/24/2011 SUPPL-5173 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103951Orig1s5173_103951Orig1s5258lbl.pdf
02/16/2010 SUPPL-5197 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103951s5197lbl.pdf
01/11/2010 SUPPL-5223 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103951s5223LBL.pdf
10/13/2009 SUPPL-5211 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103951s5211Lbl.pdf
11/19/2008 SUPPL-5195 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103951s5195PI.pdf
03/07/2008 SUPPL-5170 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103951s5170lbl.pdf
12/17/2007 SUPPL-5169 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5169lbl.pdf
11/08/2007 SUPPL-5164 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5164lbl.pdf
04/10/2007 SUPPL-5135 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5135LBL.pdf
03/09/2007 SUPPL-5139 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5139lbl.pdf
03/23/2006 SUPPL-5097 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103951s5097LBL.pdf
12/15/2005 SUPPL-5088 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103951s5088lbl.pdf
10/26/2005 SUPPL-5096 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103951s5096lbl.pdf
12/16/2004 SUPPL-5069 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103951_5069lbl.pdf
07/19/2002 SUPPL-5001 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/darbamg071902LB.pdf
09/17/2001 ORIG-1 Approval https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/darbamg091701LB.htm

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