Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125276
Company: GENENTECH
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 |
|---|---|---|---|---|---|
| 12/21/2022 | SUPPL-138 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125276s138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125276Orig1s138ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 12/21/2022 | SUPPL-138 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125276s138lbl.pdf | |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s118,125472s029lbl.pdf | |
| 11/19/2018 | SUPPL-118 | Labeling-Container/Carton Labels | 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 |