Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125418
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZALTRAP ZIV-AFLIBERCEPT 4MG 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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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