Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

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
08/30/2017 SUPPL-114 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125276Orig1s114ltr.pdf
05/22/2017 SUPPL-112 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s112lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125276Orig1s112ltr.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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125276s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125276Orig1s064ltr.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
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English