Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103234
Company: AMGEN
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 |
|---|---|---|---|---|---|
| 04/30/2024 | SUPPL-5378 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103234s5378lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103234Orig1s5378ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 04/30/2024 | SUPPL-5378 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103234s5378lbl.pdf | |
| 04/30/2024 | SUPPL-5378 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103234s5378lbl.pdf | |
| 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-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.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-5363 | 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 | |
| 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 |