Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125085
Company: GENENTECH
Company: GENENTECH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AVASTIN | BEVACIZUMAB | 100MG | VIAL; INTRAVENOUS | Prescription | None | No | No |
| AVASTIN | BEVACIZUMAB | 400MG | VIAL; INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 02/26/2004 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125085ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/STN-125085_Avastin.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/18/2022 | SUPPL-340 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125085s340lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125085Orig1s340ltr.pdf | |
| 12/09/2020 | SUPPL-337 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125085s337lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125085Orig1s337ltr.pdf | |
| 10/09/2020 | SUPPL-336 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125085s336lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125085Orig1s336ltr.pdf | |
| 09/30/2020 | SUPPL-334 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125085s334lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125085Orig1s334ltr.pdf | |
| 05/29/2020 | SUPPL-332 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125085s332lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125085Orig1s332ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/125085Orig1s332.pdf | |
| 06/20/2019 | SUPPL-331 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125085s331lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125085Orig1s331ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/125085Orig1s331.pdf | |
| 04/03/2019 | SUPPL-329 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125085Orig1s329ltr.pdf |
| 04/30/2018 | SUPPL-324 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125085s324lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125085Orig1s324ltr.pdf | |
| 06/13/2018 | SUPPL-323 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125085s323lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125085Orig1s323ltr.pdf | |
| 12/05/2017 | SUPPL-319 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125085s319lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125085s319ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/125085Orig1s319.pdf | |
| 12/06/2016 | SUPPL-317 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125085s317lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125085Orig1s317ltr.pdf | |
| 12/01/2015 | SUPPL-312 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125085s312lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125085Orig1s312ltr.pdf | |
| 09/29/2015 | SUPPL-310 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125085s310lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125085Orig1s310ltr.pdf | |
| 05/07/2015 | SUPPL-308 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125085s308lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125085Orig1s308ltr.pdf | |
| 11/14/2014 | SUPPL-305 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085s305lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125085Orig1s305ltr.pdf | |
| 08/14/2014 | SUPPL-301 | Supplement |
Label (PDF)
Letter (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085s301lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125085Orig1s301ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085Orig1s301SumR.pdf | |
| 08/30/2014 | SUPPL-297 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085s297lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125085Orig1s297ltr.pdf | |
| 12/16/2013 | SUPPL-285 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125085s285lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125085Orig1s285ltr.pdf | |
| 03/26/2013 | SUPPL-267 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125085s267lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125085Orig1s267ltr.pdf | |
| 11/20/2012 | SUPPL-265 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125085s265lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125085Orig1s265ltr.pdf | |
| 01/23/2013 | SUPPL-263 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125085s263lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125085Orig1s263ltr.pdf | |
| 12/20/2011 | SUPPL-241 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125085s0241ltr.pdf |
| 10/26/2012 | SUPPL-239 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125085s239lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125085Orig1s239ltr.pdf | |
| 05/03/2012 | SUPPL-238 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125085s0238lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125085s0238ltr.pdf | |
| 12/21/2011 | SUPPL-235 | Supplement |
Label is not available on this site. |
||
| 12/21/2011 | SUPPL-229 | Supplement |
Label is not available on this site. |
||
| 09/30/2011 | SUPPL-225 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125085s225lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125085s225ltr.pdf | |
| 02/08/2011 | SUPPL-208 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125085s208ltr.pdf |
| 12/28/2010 | SUPPL-204 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125085s204ltr.pdf |
| 05/05/2009 | SUPPL-169 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125085s0169lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125085s0169ltr.pdf | |
| 07/31/2009 | SUPPL-168 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125085s0168lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125085s0168ltr.pdf | |
| 11/04/2008 | SUPPL-163 | Supplement |
Label is not available on this site. |
||
| 03/10/2008 | SUPPL-145 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125085s145lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125085s0145ltr.pdf | |
| 09/20/2007 | SUPPL-131 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125085s131lbl.pdf | |
| 02/22/2008 | SUPPL-91 | Supplement |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125085s091ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125085_s091_avastin.pdf |
| 10/11/2006 | SUPPL-85 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125085s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125085s085ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2006/125085_0085_avastin.pdf | |
| 09/21/2006 | SUPPL-82 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125085s082LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125085s082LTR.pdf | |
| 06/20/2006 | SUPPL-74 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/0125085s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125085s074LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2006/125085_0074_avastin.pdf | |
| 04/18/2006 | SUPPL-67 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125085s067LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125085s067LTR.pdf | |
| 09/29/2005 | SUPPL-45 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125085s45lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125085s0045ltr.pdf | |
| 12/22/2004 | SUPPL-10 | Supplement |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/18/2022 | SUPPL-340 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125085s340lbl.pdf | |
| 12/09/2020 | SUPPL-337 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125085s337lbl.pdf | |
| 10/09/2020 | SUPPL-336 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125085s336lbl.pdf | |
| 09/30/2020 | SUPPL-334 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125085s334lbl.pdf | |
| 05/29/2020 | SUPPL-332 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125085s332lbl.pdf | |
| 06/20/2019 | SUPPL-331 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125085s331lbl.pdf | |
| 06/20/2019 | SUPPL-331 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125085s331lbl.pdf | |
| 06/13/2018 | SUPPL-323 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125085s323lbl.pdf | |
| 04/30/2018 | SUPPL-324 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125085s324lbl.pdf | |
| 12/05/2017 | SUPPL-319 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125085s319lbl.pdf | |
| 12/06/2016 | SUPPL-317 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125085s317lbl.pdf | |
| 12/01/2015 | SUPPL-312 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125085s312lbl.pdf | |
| 09/29/2015 | SUPPL-310 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125085s310lbl.pdf | |
| 05/07/2015 | SUPPL-308 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125085s308lbl.pdf | |
| 11/14/2014 | SUPPL-305 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085s305lbl.pdf | |
| 08/30/2014 | SUPPL-297 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085s297lbl.pdf | |
| 08/14/2014 | SUPPL-301 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085s301lbl.pdf | |
| 12/16/2013 | SUPPL-285 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125085s285lbl.pdf | |
| 03/26/2013 | SUPPL-267 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125085s267lbl.pdf | |
| 01/23/2013 | SUPPL-263 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125085s263lbl.pdf | |
| 11/20/2012 | SUPPL-265 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125085s265lbl.pdf | |
| 10/26/2012 | SUPPL-239 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125085s239lbl.pdf | |
| 05/03/2012 | SUPPL-238 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125085s0238lbl.pdf | |
| 09/30/2011 | SUPPL-225 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125085s225lbl.pdf | |
| 07/31/2009 | SUPPL-168 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125085s0168lbl.pdf | |
| 05/05/2009 | SUPPL-169 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125085s0169lbl.pdf | |
| 03/10/2008 | SUPPL-145 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125085s145lbl.pdf | |
| 09/20/2007 | SUPPL-131 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125085s131lbl.pdf | |
| 10/11/2006 | SUPPL-85 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125085s085lbl.pdf | |
| 09/21/2006 | SUPPL-82 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125085s082LBL.pdf | |
| 06/20/2006 | SUPPL-74 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/0125085s074lbl.pdf | |
| 04/18/2006 | SUPPL-67 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125085s067LBL.pdf | |
| 09/29/2005 | SUPPL-45 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125085s45lbl.pdf | |
| 02/26/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125085lbl.pdf |