Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125156
Company: GENENTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUCENTIS RANIBIZUMAB 10MG/ML 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
06/30/2006 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125156lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125156LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125156s0000_LucentisTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/20/2018 SUPPL-117 Supplement Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125156Orig1s117ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125156Orig1s117.pdf
04/15/2017 SUPPL-114 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125156s114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125156Orig1s114ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/125156Orig1s114.pdf
11/22/2016 SUPPL-112 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125156s112lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125156Orig1s112ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125156Orig1s112.pdf
01/05/2017 SUPPL-111 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125156s111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125156Orig1s111ltr.pdf
10/13/2016 SUPPL-110 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125156s110lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125156Orig1s110ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125156Orig1s110.pdf
02/06/2015 SUPPL-106 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125156s106lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125156Orig1s106ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125156Orig1s106.pdf
11/25/2014 SUPPL-105 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125156s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125156Orig1s105ltr.pdf
02/27/2014 SUPPL-94 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125156s094lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125156Orig1s094ltr.pdf
03/08/2013 SUPPL-87 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125156Orig1s087ltr.pdf
02/06/2013 SUPPL-81 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125156s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125156Orig1s081ltr.pdf
08/10/2012 SUPPL-76 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125156Orig1s0069,s0076ltr.pdf
08/10/2012 SUPPL-69 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125156Orig1s0069,s0076ltr.pdf
06/22/2010 SUPPL-53 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125156s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125156s053ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2010/125156Orig1s053.pdf
05/19/2010 SUPPL-44 Supplement

Label is not available on this site.

04/23/2008 SUPPL-11 Supplement

Label is not available on this site.

04/26/2007 SUPPL-3 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/15/2017 SUPPL-114 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125156s114lbl.pdf
01/05/2017 SUPPL-111 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125156s111lbl.pdf
11/22/2016 SUPPL-112 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125156s112lbl.pdf
10/13/2016 SUPPL-110 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125156s110lbl.pdf
02/06/2015 SUPPL-106 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125156s106lbl.pdf
11/25/2014 SUPPL-105 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125156s105lbl.pdf
02/27/2014 SUPPL-94 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125156s094lbl.pdf
02/06/2013 SUPPL-81 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125156s081lbl.pdf
08/10/2012 SUPPL-76 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf
08/10/2012 SUPPL-69 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf
06/22/2010 SUPPL-53 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125156s053lbl.pdf
06/30/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125156lbl.pdf

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