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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125156
Company: GENENTECH

Products on BLA 125156

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUCENTIS	RANIBIZUMAB	10MG/ML	INJECTABLE; INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125156

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	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125156s117lbl.pdf 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.

Labels for BLA 125156

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/20/2018	SUPPL-117	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125156s117lbl.pdf
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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