Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103951
Company: AMGEN
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://web.archive.org/web/20160317023707/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 |
|---|---|---|---|---|---|
| 04/30/2024 | SUPPL-5383 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103951Orig1s5383ltr.pdf |
| 01/30/2019 | SUPPL-5378 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103951s5378lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103951Orig1s5378ltr.pdf | |
| 12/20/2018 | SUPPL-5377 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103951s5377lbl.pdf | |
| 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 |
|---|---|---|---|---|---|
| 01/30/2019 | SUPPL-5378 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103951s5378lbl.pdf | |
| 12/20/2018 | SUPPL-5377 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103951s5377lbl.pdf | |
| 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 |