Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125476
Company: TAKEDA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ENTYVIO VEDOLIZUMAB 300MG 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
05/20/2014 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125476s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125476Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125476Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125476Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/17/2021 SUPPL-39 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125476s038s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125476Orig1s038, s039ltr.pdf
08/17/2021 SUPPL-38 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125476Orig1s038, s039ltr.pdf
03/31/2020 SUPPL-30 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125476s025s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125476Orig1s025, s030ltr.pdf
05/06/2019 SUPPL-27 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125476Orig1s027ltr.pdf
03/31/2020 SUPPL-25 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125476s025s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125476Orig1s025, s030ltr.pdf
05/07/2019 SUPPL-24 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125476s024lbl.pdf
02/16/2018 SUPPL-22 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125476s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125476Orig1s022ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/17/2021 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125476s038s039lbl.pdf
03/31/2020 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125476s025s030lbl.pdf
03/31/2020 SUPPL-30 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125476s025s030lbl.pdf
03/31/2020 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125476s025s030lbl.pdf
05/07/2019 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125476s024lbl.pdf
02/16/2018 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125476s022lbl.pdf
05/20/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125476s000lbl.pdf

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