Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125057
Company: ABBVIE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMIRA ADALIMUMAB 40MG/0.8ML SYRINGE Prescription None No No
HUMIRA ADALIMUMAB 40MG/0.8ML VIAL 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
12/31/2002 ORIG-1 Approval N/A; Orphan Label
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/adalabb123102LB.htm https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/adalabb123102L.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125057_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/11/2019 SUPPL-411 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125057Orig1s411ltr.pdf
12/06/2018 SUPPL-410 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s410lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125057s410ltr.pdf
10/16/2018 SUPPL-409 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s409lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125057Orig1s409ltr.pdf
09/28/2018 SUPPL-408 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s408lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125057Orig1s408ltr.pdf
08/02/2018 SUPPL-406 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s406lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125057Orig1s406ltr.pdf
12/14/2017 SUPPL-403 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s403lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125057Orig1s403ltr.pdf
04/28/2017 SUPPL-402 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s402lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125057Orig1s402ltr.pdf
04/21/2017 SUPPL-401 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s401lbl.pdf
10/17/2016 SUPPL-400 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125057s400lbl.pdf
03/27/2017 SUPPL-399 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s399lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125057Orig1s399ltr.pdf
06/30/2016 SUPPL-397 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125057s397lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125057Orig1s397ltr.pdf
11/23/2015 SUPPL-394 Supplement Label (PDF)
Letter (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125057s394lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125057Orig1s394ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125057Orig1s394SumR.pdf
09/09/2015 SUPPL-393 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125057Orig1s393ltr.pdf
11/06/2014 SUPPL-390 Supplement

Label is not available on this site.

10/29/2014 SUPPL-384 Supplement

Label is not available on this site.

08/07/2014 SUPPL-381 Supplement Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/bla/2014/125057Orig1s381.pdf
05/14/2014 SUPPL-368 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s368lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s368ltr.pdf
09/30/2014 SUPPL-367 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s367lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s367ltr.pdf
05/30/2014 SUPPL-366 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s366lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s366ltr.pdf
09/23/2014 SUPPL-356 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s356lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s356ltr.pdf
02/26/2014 SUPPL-355 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057Orig1s355lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s355_replace_ltr.pdf
09/19/2013 SUPPL-327 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s327lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125057Orig1s327ltr.pdf
04/24/2013 SUPPL-322 Supplement Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s322lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125057Orig1s322.pdf
05/13/2013 SUPPL-310 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s310lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125057Orig1s310ltr.pdf
12/24/2014 SUPPL-280 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s280ltr.pdf
05/24/2012 SUPPL-278 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125057s0278lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057s0278ltr.pdf
12/26/2011 SUPPL-276 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0276lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s276ltr.pdf
12/13/2011 SUPPL-271 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057s271ltr.pdf
09/07/2011 SUPPL-255 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s255ltr.pdf
07/13/2011 SUPPL-254 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s254ltr.pdf
09/28/2012 SUPPL-232 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125057s232lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057Orig1s232ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125057Orig1s232.pdf
09/29/2010 SUPPL-224 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s224ltr.pdf
02/25/2011 SUPPL-215 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0215lbl.pdf
07/29/2010 SUPPL-213 Supplement Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s0213ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2010/125057Orig1s0213.pdf
11/18/2010 SUPPL-196 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125057s196lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125057s0196ltr.pdf
04/08/2010 SUPPL-161 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s161ltr.pdf
03/11/2009 SUPPL-141 Supplement

Label is not available on this site.

03/14/2011 SUPPL-128 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s128ltr.pdf
02/21/2008 SUPPL-114 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125057s114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125057s114ltr.pdf
01/18/2008 SUPPL-110 Supplement Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125057s0110lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125057s0110ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125057s110TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125057s110_SumR.pdf
09/05/2007 SUPPL-108 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s108_ltr.pdf
11/09/2006 SUPPL-95 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s071, s095LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125057s071, s095LTR.pdf
07/30/2007 SUPPL-94 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s094_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s094ltr.pdf
02/27/2007 SUPPL-89 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s089Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s089Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2007/125057_S0089.pdf
11/09/2006 SUPPL-71 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s071, s095LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125057s071, s095LTR.pdf
06/23/2006 SUPPL-65 Supplement

Label is not available on this site.

07/28/2006 SUPPL-62 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s062lbl.pdf
02/16/2007 SUPPL-60 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s060LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s060LTR.pdf
10/03/2005 SUPPL-46 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125057s0045,0046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125057s0046ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2005/125057Orig1s046.pdf
10/03/2005 SUPPL-45 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125057s0045,0046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125057s0045ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2005/125057Orig1s045.pdf
06/18/2004 SUPPL-23 Supplement Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/125057_0023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/125057Orig1s023.pdf
07/30/2004 SUPPL-16 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125057_0016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125057_0016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2004/125057Orig1s016.pdf
09/12/2003 SUPPL-4 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/06/2018 SUPPL-410 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s410lbl.pdf
10/16/2018 SUPPL-409 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s409lbl.pdf
09/28/2018 SUPPL-408 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s408lbl.pdf
08/02/2018 SUPPL-406 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s406lbl.pdf
12/14/2017 SUPPL-403 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s403lbl.pdf
04/28/2017 SUPPL-402 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s402lbl.pdf
04/21/2017 SUPPL-401 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s401lbl.pdf
03/27/2017 SUPPL-399 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s399lbl.pdf
10/17/2016 SUPPL-400 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125057s400lbl.pdf
06/30/2016 SUPPL-397 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125057s397lbl.pdf
11/23/2015 SUPPL-394 Efficacy-Manufacturing Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125057s394lbl.pdf
09/30/2014 SUPPL-367 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s367lbl.pdf
09/23/2014 SUPPL-356 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s356lbl.pdf
05/30/2014 SUPPL-366 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s366lbl.pdf
05/14/2014 SUPPL-368 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s368lbl.pdf
02/26/2014 SUPPL-355 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057Orig1s355lbl.pdf
09/19/2013 SUPPL-327 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s327lbl.pdf
05/13/2013 SUPPL-310 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s310lbl.pdf
04/24/2013 SUPPL-322 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s322lbl.pdf
09/28/2012 SUPPL-232 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125057s232lbl.pdf
05/24/2012 SUPPL-278 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125057s0278lbl.pdf
12/26/2011 SUPPL-276 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0276lbl.pdf
02/25/2011 SUPPL-215 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0215lbl.pdf
11/18/2010 SUPPL-196 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125057s196lbl.pdf
02/21/2008 SUPPL-114 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125057s114lbl.pdf
01/18/2008 SUPPL-110 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125057s0110lbl.pdf
09/05/2007 SUPPL-108 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s108lbl.pdf
07/30/2007 SUPPL-94 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s094_LBL.pdf
02/27/2007 SUPPL-89 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s089Lbl.pdf
02/16/2007 SUPPL-60 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s060LBL.pdf
11/09/2006 SUPPL-95 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s071, s095LBL.pdf
11/09/2006 SUPPL-71 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s071, s095LBL.pdf
07/28/2006 SUPPL-62 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s062lbl.pdf
10/03/2005 SUPPL-46 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125057s0045,0046lbl.pdf
10/03/2005 SUPPL-45 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125057s0045,0046lbl.pdf
07/30/2004 SUPPL-16 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125057_0016lbl.pdf
12/31/2002 ORIG-1 Approval https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/adalabb123102LB.htm

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