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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125476
Company: TAKEDA PHARMS USA

Medication Guide

Summary Review

Products on BLA 125476

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENTYVIO	VEDOLIZUMAB	300MG	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125476

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
04/18/2024	SUPPL-61	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761359Orig1s000; 761133Orig1s005; s006; 125476Orig1s060; s061ltr.pdf
04/18/2024	SUPPL-60	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761359Orig1s000; 761133Orig1s005; s006; 125476Orig1s060; s061ltr.pdf
03/14/2024	SUPPL-58	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s058,761133s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125476Orig1s058, 761133Orig1s004ltr.pdf
09/28/2023	SUPPL-57	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125476s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125476Orig1s057ltr.pdf
02/23/2024	SUPPL-54	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s054,761133s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125476Orig1s054; 761133Orig1s003ltr.pdf
01/25/2023	SUPPL-48	Supplement		Label is not available on this site.
06/17/2022	SUPPL-46	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125476Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125476Orig1s046ltr.pdf
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

Labels for BLA 125476

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/14/2024	SUPPL-58	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s058,761133s004lbl.pdf
02/23/2024	SUPPL-54	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s054,761133s003lbl.pdf
09/28/2023	SUPPL-57	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125476s057lbl.pdf
09/28/2023	SUPPL-57	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125476s057lbl.pdf
06/17/2022	SUPPL-46	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125476Orig1s046lbl.pdf
06/17/2022	SUPPL-46	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125476Orig1s046lbl.pdf
06/17/2022	SUPPL-46	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125476Orig1s046lbl.pdf
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-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125476s025s030lbl.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-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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