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Biologic License Application (BLA): 125276
Company: GENENTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACTEMRA TOCILIZUMAB 80MG/4ML INJECTABLE; INJECTION Prescription None No No
ACTEMRA TOCILIZUMAB 200MG/10ML INJECTABLE; INJECTION Prescription None No No
ACTEMRA TOCILIZUMAB 400MG/20ML INJECTABLE; INJECTION 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
01/08/2010 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125276lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125276s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125276s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125276s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/22/2021 SUPPL-135 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125472Orig1s045, 125276Orig1s135ltr.pdf
02/28/2022 SUPPL-134 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125276s134lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125276Orig1s134ltr.pdf
03/04/2021 SUPPL-131 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125276s131lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125276Orig1s131ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/125276Orig1s131.pdf
05/28/2020 SUPPL-129 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125276s129,125472s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125472Orig1s042,125276Orig1s129ltr.pdf
06/11/2019 SUPPL-127 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125276s127,125472s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125276Orig1s127; 125472Orig1s040ltr.pdf
12/20/2018 SUPPL-125 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s125,125472s038lbl.pdf
09/12/2018 SUPPL-122 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s122,125472s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125472Orig1s031,125276Orig1s122Ltr.pdf
04/11/2019 SUPPL-121 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125276s120s121lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125276Orig1s120, s121ltr.pdf
04/11/2019 SUPPL-120 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125276s120s121lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125276Orig1s120, s121ltr.pdf
11/19/2018 SUPPL-118 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s118,125472s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125472Orig1s029,125276Orig1s118ltr.pdf
05/17/2018 SUPPL-117 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s117,125472s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125276Orig1s117,125472Orig1s032ltr.pdf
03/22/2018 SUPPL-116 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s116,125472s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125276Orig1s116,125472Orig1s030ltr.pdf
05/11/2018 SUPPL-115 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s115,125472s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125276Orig1s115,125472Orig1s028ltr.pdf
08/30/2017 SUPPL-114 Supplement Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125276Orig1s114ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/125276Orig1s114TOC.cfm
05/22/2017 SUPPL-112 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s112lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125276Orig1s112ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/125276Orig1s112.pdf
03/30/2017 SUPPL-111 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s111,125472s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125276Orig1s111,125472Orig1s023ltr.pdf
09/23/2016 SUPPL-107 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125276s107_125472s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125276Orig1s107,125472Orig1s018ltr.pdf
08/18/2015 SUPPL-106 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125276s106,125472s014ltr.pdf
11/13/2014 SUPPL-105 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125276Orig1s105ltr.pdf
10/21/2013 SUPPL-92 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125276s092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125276Orig1s092ltr.pdf
07/02/2013 SUPPL-75 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125276Orig1s075ltr.pdf
04/29/2013 SUPPL-64 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125276s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125276Orig1s064ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125276Orig1s064.pdf
10/11/2012 SUPPL-49 Supplement Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125276s0049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125276Orig1s0049ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2012/125276Orig1s049TOC.cfm
06/20/2012 SUPPL-48 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125276s0048ltr.pdf
08/13/2012 SUPPL-46 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125276s0046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125276Orig1s0046ltr.pdf
04/15/2011 SUPPL-23 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s0022s0023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125276s0022,s0023ltr.pdf
04/15/2011 SUPPL-22 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s0022s0023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125276s0022,s0023ltr.pdf
01/04/2011 SUPPL-11 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s007s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125276s007,s010,s011ltr.pdf
01/04/2011 SUPPL-10 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s007s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125276s007,s010,s011ltr.pdf
01/04/2011 SUPPL-7 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s007s010s011lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/28/2022 SUPPL-134 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125276s134lbl.pdf
03/04/2021 SUPPL-131 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125276s131lbl.pdf
03/04/2021 SUPPL-131 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125276s131lbl.pdf
05/28/2020 SUPPL-129 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125276s129,125472s042lbl.pdf
06/11/2019 SUPPL-127 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125276s127,125472s040lbl.pdf
04/11/2019 SUPPL-121 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125276s120s121lbl.pdf
04/11/2019 SUPPL-120 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125276s120s121lbl.pdf
12/20/2018 SUPPL-125 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s125,125472s038lbl.pdf
11/19/2018 SUPPL-118 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s118,125472s029lbl.pdf
11/19/2018 SUPPL-118 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s118,125472s029lbl.pdf
09/12/2018 SUPPL-122 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s122,125472s031lbl.pdf
05/17/2018 SUPPL-117 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s117,125472s032lbl.pdf
05/11/2018 SUPPL-115 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s115,125472s028lbl.pdf
03/22/2018 SUPPL-116 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s116,125472s030lbl.pdf
08/30/2017 SUPPL-114 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s114lbl.pdf
05/22/2017 SUPPL-112 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s112lbl.pdf
05/22/2017 SUPPL-112 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s112lbl.pdf
03/30/2017 SUPPL-111 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s111,125472s023lbl.pdf
09/23/2016 SUPPL-107 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125276s107_125472s018lbl.pdf
10/21/2013 SUPPL-92 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125276s092lbl.pdf
04/29/2013 SUPPL-64 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125276s064lbl.pdf
10/11/2012 SUPPL-49 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125276s0049lbl.pdf
08/13/2012 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125276s0046lbl.pdf
04/15/2011 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s0022s0023lbl.pdf
04/15/2011 SUPPL-22 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s0022s0023lbl.pdf
01/04/2011 SUPPL-11 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s007s010s011lbl.pdf
01/04/2011 SUPPL-10 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s007s010s011lbl.pdf
01/04/2011 SUPPL-7 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s007s010s011lbl.pdf
01/08/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125276lbl.pdf
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