Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 761049
Company: EMD SERONO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BAVENCIO AVELUMAB 20MG/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
03/23/2017 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761049Orig1s000ltredt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761049Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/19/2018 SUPPL-3 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761049s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761049Orig1s003ltr.pdf
10/12/2017 SUPPL-2 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761049Orig1s002ltr.pdf
04/25/2017 SUPPL-1 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761049Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/19/2018 SUPPL-3 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761049s003lbl.pdf
10/12/2017 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s002lbl.pdf
03/23/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s000lbl.pdf

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