Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103234
Company: AMGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPOGEN/PROCRIT EPOETIN ALFA 10,000U/ML VIAL; SINGLE-USE Prescription None No No
EPOGEN/PROCRIT EPOETIN ALFA 20,000U/2ML VIAL; MULTIDOSE Prescription None No No
EPOGEN/PROCRIT EPOETIN ALFA 20,000/ML VIAL; MULTIDOSE Prescription None No No
EPOGEN/PROCRIT EPOETIN ALFA 2,000U/ML VIAL; SINGLE-USE Prescription None No No
EPOGEN/PROCRIT EPOETIN ALFA 3,000U/ML VIAL; SINGLE-USE Prescription None No No
EPOGEN/PROCRIT EPOETIN ALFA 40,000U/ML VIAL; SINGLE-USE Prescription None No No
EPOGEN/PROCRIT EPOETIN ALFA 4,000U/ML VIAL; SINGLE-USE 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
06/01/1989 ORIG-1 Approval N/A; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/25/2018 SUPPL-5369 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103234s5369lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103234Orig1s5369Ltr.pdf
09/29/2017 SUPPL-5366 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103234Orig1s5363s5366ltr.pdf
04/13/2017 SUPPL-5364 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5360s5364lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103234Orig1s5360s5364ltr.pdf
09/29/2017 SUPPL-5363 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103234Orig1s5363s5366ltr.pdf
04/13/2017 SUPPL-5360 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5360s5364lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103234Orig1s5360s5364ltr.pdf
03/27/2013 SUPPL-5329 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103234Orig1s5329ltr.pdf
12/31/2013 SUPPL-5323 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103234s5323lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103234Orig1s5323ltr.pdf
05/31/2012 SUPPL-5281 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103234s5281lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103234s5281ltr.pdf
06/24/2011 SUPPL-5266 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103234Orig1s5166_103234Orig1s5266lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103234s5166,s5266ltr.pdf
06/24/2011 SUPPL-5256 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-5232 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103234s5232LBL.pdf
10/13/2009 SUPPL-5221 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103234s5221Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103234s5221ltr.pdf
02/16/2010 SUPPL-5199 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103234s5199lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103234s5199ltr.pdf
11/19/2008 SUPPL-5196 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5196PI.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103234s5195,s5196ltr.pdf
11/19/2008 SUPPL-5195 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5195sPI.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103234s5195,s5196ltr.pdf
06/24/2011 SUPPL-5166 Supplement Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103234Orig1s5166_103234Orig1s5266lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103234s5166,103234s5266ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/103234_epogen_procrit_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103234Orig1s5166SumR.pdf
03/07/2008 SUPPL-5164 Supplement Label (PDF)
Patient Package Insert (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5164lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5164ppi.pdf
12/17/2007 SUPPL-5163 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103234s5163lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103234s5163ltr.pdf
11/08/2007 SUPPL-5158 Supplement Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103234s5158lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103234s5158ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103234s5158ppi.pdf
03/09/2007 SUPPL-5122 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103234s5122lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103234s5122ltr.pdf
05/11/2006 SUPPL-5104 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103234s5104_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103234s5104_LTR.pdf
10/26/2005 SUPPL-5093 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103234s5093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103234s5093ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/103234s5093_AP_PKG.pdf
10/27/2005 SUPPL-5082 Supplement

Label is not available on this site.

11/10/2004 SUPPL-5076 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103234_5076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103234_5076ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/103234s5076_AP_PKG.pdf
06/30/2004 SUPPL-5053 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103234_5053_Epogen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/103234_5053ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/103234s5053.pdf
05/07/2003 SUPPL-5034 Supplement

Label is not available on this site.

05/21/2004 SUPPL-5033 Supplement Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/103234-5033ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/103234s5033.pdf
09/29/2000 SUPPL-1062 Supplement

Label is not available on this site.

10/19/2004 SUPPL-1058 Supplement

Label is not available on this site.

07/26/1999 SUPPL-1046 Supplement Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/epoamg072699lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/epoamg072699L.pdf https://web.archive.org/web/20170113111355/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080580.htm
12/23/1996 SUPPL-1036 Supplement

Label is not available on this site.

06/29/1994 SUPPL-1016 Supplement

Label is not available on this site.

04/01/1993 SUPPL-1015 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/103234s1015_LBL.pdf
12/31/1990 SUPPL-1009 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/25/2018 SUPPL-5369 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103234s5369lbl.pdf
09/29/2017 SUPPL-5366 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf
09/29/2017 SUPPL-5366 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf
09/29/2017 SUPPL-5363 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf
09/29/2017 SUPPL-5363 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf
04/13/2017 SUPPL-5364 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5360s5364lbl.pdf
04/13/2017 SUPPL-5364 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5360s5364lbl.pdf
04/13/2017 SUPPL-5364 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5360s5364lbl.pdf
04/13/2017 SUPPL-5360 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5360s5364lbl.pdf
12/31/2013 SUPPL-5323 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103234s5323lbl.pdf
05/31/2012 SUPPL-5281 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103234s5281lbl.pdf
06/24/2011 SUPPL-5266 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103234Orig1s5166_103234Orig1s5266lbl.pdf
06/24/2011 SUPPL-5166 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103234Orig1s5166_103234Orig1s5266lbl.pdf
02/16/2010 SUPPL-5199 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103234s5199lbl.pdf
01/11/2010 SUPPL-5232 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103234s5232LBL.pdf
10/13/2009 SUPPL-5221 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103234s5221Lbl.pdf
11/19/2008 SUPPL-5196 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5196PI.pdf
11/19/2008 SUPPL-5195 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5195sPI.pdf
03/07/2008 SUPPL-5164 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5164lbl.pdf
12/17/2007 SUPPL-5163 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103234s5163lbl.pdf
11/08/2007 SUPPL-5158 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103234s5158lbl.pdf
03/09/2007 SUPPL-5122 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103234s5122lbl.pdf
05/11/2006 SUPPL-5104 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103234s5104_LBL.pdf
10/26/2005 SUPPL-5093 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103234s5093lbl.pdf
11/10/2004 SUPPL-5076 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103234_5076lbl.pdf
06/30/2004 SUPPL-5053 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103234_5053_Epogen_lbl.pdf
07/26/1999 SUPPL-1046 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/epoamg072699lb.pdf
04/01/1993 SUPPL-1015 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/103234s1015_LBL.pdf

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