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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125418
Company: SANOFI AVENTIS US

Summary Review

Products on BLA 125418

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZALTRAP	ZIV-AFLIBERCEPT	4MG	INJECTABLE; INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125418

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/2012	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125418s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125418Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125418_zaltrap_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125418Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2023	SUPPL-54	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125418s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125418Orig1s054ltr.pdf
06/05/2020	SUPPL-47	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125418s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125418Orig1s047ltr.pdf
03/11/2020	SUPPL-46	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125418s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125418Orig1s046ltr.pdf
11/25/2019	SUPPL-45	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125418s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125418Orig1s045ltr.pdf
06/24/2016	SUPPL-39	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125418s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125418Orig1s039ltr.pdf
03/09/2016	SUPPL-37	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125418s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125418Orig1s037ltr.pdf
09/17/2015	SUPPL-33	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125418Orig1s033ltr.pdf
10/25/2013	SUPPL-20	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125418s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125418Orig1s020ltr.pdf

Labels for BLA 125418

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2023	SUPPL-54	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125418s054lbl.pdf
06/05/2020	SUPPL-47	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125418s047lbl.pdf
03/11/2020	SUPPL-46	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125418s046lbl.pdf
11/25/2019	SUPPL-45	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125418s045lbl.pdf
06/24/2016	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125418s039lbl.pdf
03/09/2016	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125418s037lbl.pdf
10/25/2013	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125418s020lbl.pdf
08/03/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125418s000lbl.pdf

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