Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103795
Company: IMMUNEX
Company: IMMUNEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ENBREL | ETANERCEPT | 25MG/VIAL | VIAL; SUBCUTANEOUS | Prescription | None | No | No |
| ENBREL | ETANERCEPT | 50MG/ML | SYRINGE | 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 |
|---|---|---|---|---|---|---|---|
| 11/02/1998 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/etanimm110298lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/etanimm110298L.htm https://web.archive.org/web/20170118085127/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080536.htm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/12/2024 | SUPPL-5600 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103795s5600lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103795Orig1s5600ltr.pdf | |
| 07/22/2024 | SUPPL-5599 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103795s5597s5598s5599lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103795Orig1s5597,s5598,s5599ltr.pdf | |
| 07/22/2024 | SUPPL-5598 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103795s5597s5598s5599lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103795Orig1s5597,s5598,s5599ltr.pdf | |
| 07/22/2024 | SUPPL-5597 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103795s5597s5598s5599lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103795Orig1s5597,s5598,s5599ltr.pdf | |
| 10/18/2023 | SUPPL-5595 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103795s5595lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/103795Orig1s5595ltr.pdf | |
| 06/09/2023 | SUPPL-5594 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103795s5594lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/103795Orig1s5594ltr.pdf | |
| 08/16/2022 | SUPPL-5591 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103795s5591lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/103795Orig1s5591ltr.pdf | |
| 06/17/2022 | SUPPL-5590 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103795Orig1s5590lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/103795Orig1s5590ltr.pdf | |
| 02/26/2021 | SUPPL-5582 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103795s5582lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103795Orig1s5582ltr.pdf | |
| 03/05/2020 | SUPPL-5577 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103795Orig1s5574, s5577ltr.pdf |
| 03/05/2020 | SUPPL-5574 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103795s5574s5577lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103795Orig1s5574, s5577ltr.pdf | |
| 02/14/2019 | SUPPL-5571 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103795Orig1s5571ltr.pdf |
| 10/03/2018 | SUPPL-5569 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103795s5569lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103795Orig1s5569ltr.pdf | |
| 05/11/2018 | SUPPL-5565 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103795Orig1s5565ltr.pdf |
| 05/25/2018 | SUPPL-5564 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103795s5563s5564lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103795Orig1s5563s5564ltr.pdf | |
| 05/25/2018 | SUPPL-5563 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103795s5563s5564lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103795Orig1s5563s5564ltr.pdf | |
| 10/06/2017 | SUPPL-5561 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103795s5561lbl.pdf | |
| 11/22/2017 | SUPPL-5559 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103795Orig1s5559ltr.pdf |
| 09/14/2017 | SUPPL-5556 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103795s5556lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103795Orig1s5556ltredt.pdf | |
| 11/04/2016 | SUPPL-5552 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103795s5552lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103795Orig1s5552ltr.pdf | |
| 07/11/2017 | SUPPL-5551 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103795s5551lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103795Orig1s5551ltr.pdf | |
| 03/25/2015 | SUPPL-5548 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103795s5548lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103795Orig1s5548ltr.pdf | |
| 03/20/2015 | SUPPL-5532 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103795s5532lbl.pdf | |
| 11/15/2013 | SUPPL-5531 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103795s5531lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103795Orig1s5531ltr.pdf | |
| 12/10/2012 | SUPPL-5507 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103795s5507lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103795Orig1s5507ltr.pdf | |
| 12/04/2012 | SUPPL-5503 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103795s5503lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103795Orig1s5503ltr.pdf | |
| 12/22/2011 | SUPPL-5484 | Supplement |
Label is not available on this site. |
||
| 09/07/2011 | SUPPL-5475 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103795s5475ltr.pdf |
| 08/10/2011 | SUPPL-5474 | Supplement |
Label is not available on this site. |
||
| 11/29/2011 | SUPPL-5462 | Supplement |
Label is not available on this site. |
||
| 10/13/2010 | SUPPL-5445 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5445ltr.pdf |
| 09/29/2010 | SUPPL-5443 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5443ltr.pdf |
| 07/29/2010 | SUPPL-5437 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5437ltr.pdf |
| 01/25/2011 | SUPPL-5431 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103795s5431ltr.pdf |
| 11/18/2010 | SUPPL-5415 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103795s5415lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103795s5415ltr.pdf | |
| 06/03/2010 | SUPPL-5400 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5391s5397s5400ltr.pdf |
| 06/03/2010 | SUPPL-5397 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5391s5397s5400ltr.pdf |
| 07/20/2010 | SUPPL-5391 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103795s5391s5397s5400ltr.pdf |
| 06/23/2008 | SUPPL-5359 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103795s5359lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103795s5359ltr.pdf | |
| 03/21/2008 | SUPPL-5356 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/enbrel_pi.pdf | |
| 10/31/2007 | SUPPL-5338 | Supplement |
Label is not available on this site. |
||
| 08/02/2007 | SUPPL-5336 | Supplement |
Label is not available on this site. |
||
| 06/29/2007 | SUPPL-5333 | Supplement |
Label is not available on this site. |
||
| 06/21/2007 | SUPPL-5328 | Supplement |
Label is not available on this site. |
||
| 02/01/2007 | SUPPL-5322 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103795s5322lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103795s5322ltr.pdf | |
| 12/08/2006 | SUPPL-5317 | Supplement |
Label is not available on this site. |
||
| 11/09/2006 | SUPPL-5313 | Supplement |
Label is not available on this site. |
||
| 11/02/2006 | SUPPL-5310 | Supplement |
Label is not available on this site. |
||
| 12/01/2006 | SUPPL-5304 | Supplement |
Label is not available on this site. |
||
| 12/01/2006 | SUPPL-5302 | Supplement |
Label is not available on this site. |
||
| 01/12/2007 | SUPPL-5301 | Supplement |
Label is not available on this site. |
||
| 11/02/2006 | SUPPL-5296 | Supplement |
Label is not available on this site. |
||
| 09/25/2006 | SUPPL-5294 | Supplement |
Label is not available on this site. |
||
| 04/26/2006 | SUPPL-5289 | Supplement |
Label is not available on this site. |
||
| 06/14/2006 | SUPPL-5286 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103795s5286lbl.pdf | |
| 06/16/2006 | SUPPL-5285 | Supplement |
Label is not available on this site. |
||
| 04/13/2006 | SUPPL-5283 | Supplement |
Label is not available on this site. |
||
| 04/04/2006 | SUPPL-5278 | Supplement |
Label is not available on this site. |
||
| 03/21/2006 | SUPPL-5277 | Supplement |
Label is not available on this site. |
||
| 04/04/2006 | SUPPL-5274 | Supplement |
Label is not available on this site. |
||
| 03/02/2006 | SUPPL-5273 | Supplement |
Label is not available on this site. |
||
| 03/23/2006 | SUPPL-5271 | Supplement |
Label is not available on this site. |
||
| 03/02/2006 | SUPPL-5266 | Supplement |
Label is not available on this site. |
||
| 02/16/2006 | SUPPL-5262 | Supplement |
Label is not available on this site. |
||
| 02/07/2006 | SUPPL-5260 | Supplement |
Label is not available on this site. |
||
| 01/24/2006 | SUPPL-5259 | Supplement |
Label is not available on this site. |
||
| 05/17/2006 | SUPPL-5256 | Supplement |
Label is not available on this site. |
||
| 07/28/2005 | SUPPL-5229 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103795_5229lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103795_5229ltr.pdf | |
| 06/28/2005 | SUPPL-5225 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103795s5225lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103795s5225ltr.pdf | |
| 05/27/2005 | SUPPL-5191 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103795_5191lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103795_5191ltr.pdf | |
| 09/27/2004 | SUPPL-5184 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103795s5184lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103795s5184ltr.pdf | |
| 09/24/2004 | SUPPL-5162 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103795s5162lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103795_5162LTR.pdf | |
| 04/30/2004 | SUPPL-5149 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/biologics/103795_5149ppi.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/103795_5149ltr.pdf | |
| 11/25/2003 | SUPPL-5125 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5125ltr.pdf |
| 07/24/2003 | SUPPL-5123 | Supplement |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5123ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103795s5123_EnbrelTOC.cfm |
| 10/17/2003 | SUPPL-5110 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5110ltr.pdf |
| 06/05/2003 | SUPPL-5109 | Supplement |
Label (PDF)
Letter Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/etanimm060503LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/etanimm060503L.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103795_S5109_ENBREL.pdf | |
| 08/21/2003 | SUPPL-5102 | Supplement |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5102ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103795-5102_Enbrel.cfm |
| 10/09/2003 | SUPPL-5099 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5099ltr.pdf |
| 07/24/2003 | SUPPL-5097 | Supplement |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5097ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103795_S5097_ENBREL.pdf |
| 08/30/2002 | SUPPL-5071 | Supplement |
Label is not available on this site. |
||
| 09/12/2002 | SUPPL-5070 | Supplement |
Label is not available on this site. |
||
| 07/24/2003 | SUPPL-5055 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103795-5055ltr.pdf |
| 09/12/2002 | SUPPL-5051 | Supplement |
Label (PDF)
Letter (PDF) Patient Package Insert (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/etanimm091202LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/etanimm091202L.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/etanimm091202PLB.pdf | |
| 01/15/2002 | SUPPL-5034 | Supplement |
Label (PDF)
Letter Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/etanimm011502LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/etanimm011502L.htm https://web.archive.org/web/20170113111347/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080570.htm | |
| 01/15/2002 | SUPPL-5016 | Supplement |
Label is not available on this site. |
||
| 06/15/2001 | SUPPL-5015 | Supplement |
Label is not available on this site. |
||
| 01/15/2002 | SUPPL-5014 | Supplement |
Label is not available on this site. |
||
| 06/06/2000 | SUPPL-1004 | Supplement |
Label
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/etanimm060600lb.txt https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/etanimm060600L.htm | |
| 05/27/1999 | SUPPL-1001 | Supplement |
Letter
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/etanimm052799L.htm https://web.archive.org/web/20160413105708/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080578.htm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/12/2024 | SUPPL-5600 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103795s5600lbl.pdf | |
| 09/12/2024 | SUPPL-5600 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103795s5600lbl.pdf | |
| 07/22/2024 | SUPPL-5599 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103795s5597s5598s5599lbl.pdf | |
| 07/22/2024 | SUPPL-5598 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103795s5597s5598s5599lbl.pdf | |
| 07/22/2024 | SUPPL-5598 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103795s5597s5598s5599lbl.pdf | |
| 07/22/2024 | SUPPL-5597 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103795s5597s5598s5599lbl.pdf | |
| 10/18/2023 | SUPPL-5595 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103795s5595lbl.pdf | |
| 06/09/2023 | SUPPL-5594 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103795s5594lbl.pdf | |
| 06/09/2023 | SUPPL-5594 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103795s5594lbl.pdf | |
| 06/09/2023 | SUPPL-5594 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103795s5594lbl.pdf | |
| 08/16/2022 | SUPPL-5591 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103795s5591lbl.pdf | |
| 06/17/2022 | SUPPL-5590 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103795Orig1s5590lbl.pdf | |
| 02/26/2021 | SUPPL-5582 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103795s5582lbl.pdf | |
| 03/05/2020 | SUPPL-5574 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103795s5574s5577lbl.pdf | |
| 10/03/2018 | SUPPL-5569 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103795s5569lbl.pdf | |
| 05/25/2018 | SUPPL-5564 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103795s5563s5564lbl.pdf | |
| 05/25/2018 | SUPPL-5563 | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103795s5563s5564lbl.pdf | ||
| 10/06/2017 | SUPPL-5561 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103795s5561lbl.pdf | |
| 09/14/2017 | SUPPL-5556 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103795s5556lbl.pdf | |
| 07/11/2017 | SUPPL-5551 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103795s5551lbl.pdf | |
| 11/04/2016 | SUPPL-5552 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103795s5552lbl.pdf | |
| 03/25/2015 | SUPPL-5548 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103795s5548lbl.pdf | |
| 03/20/2015 | SUPPL-5532 | Supplement | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103795s5532lbl.pdf | |
| 11/15/2013 | SUPPL-5531 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103795s5531lbl.pdf | |
| 12/10/2012 | SUPPL-5507 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103795s5507lbl.pdf | |
| 12/04/2012 | SUPPL-5503 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103795s5503lbl.pdf | |
| 11/18/2010 | SUPPL-5415 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103795s5415lbl.pdf | |
| 06/23/2008 | SUPPL-5359 | Supplement | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103795s5359lbl.pdf | |
| 03/21/2008 | SUPPL-5356 | Supplement | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/enbrel_pi.pdf | |
| 02/01/2007 | SUPPL-5322 | Supplement | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103795s5322lbl.pdf | |
| 06/14/2006 | SUPPL-5286 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103795s5286lbl.pdf | |
| 07/28/2005 | SUPPL-5229 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103795_5229lbl.pdf | |
| 06/28/2005 | SUPPL-5225 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103795s5225lbl.pdf | |
| 05/27/2005 | SUPPL-5191 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103795_5191lbl.pdf | |
| 09/27/2004 | SUPPL-5184 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103795s5184lbl.pdf | |
| 09/24/2004 | SUPPL-5162 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103795s5162lbl.pdf | |
| 04/30/2004 | SUPPL-5149 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/biologics/103795_5149ppi.pdf | |
| 06/05/2003 | SUPPL-5109 | Supplement | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/etanimm060503LB.pdf | |
| 09/12/2002 | SUPPL-5051 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/etanimm091202LB.pdf | |
| 01/15/2002 | SUPPL-5034 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/etanimm011502LB.pdf | |
| 06/06/2000 | SUPPL-1004 | Efficacy | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/etanimm060600lb.txt | ||
| 11/02/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/etanimm110298lb.pdf |