Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103795
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
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
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

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