Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125085
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
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
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

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