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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761208
Company: SEAGEN

Medication Guide

Products on BLA 761208

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIVDAK	TISOTUMAB VEDOTIN-TFTV	40MG	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761208

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/20/2021	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761208Orig1s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761208Orig1s000_Corrected_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761208Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2024	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761208s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761208Orig1s007ltr.pdf
07/26/2023	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761208s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761208Orig1s005ltr.pdf

Labels for BLA 761208

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2024	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761208s007lbl.pdf
07/26/2023	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761208s005lbl.pdf
07/26/2023	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761208s005lbl.pdf
09/20/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761208Orig1s000lbledt.pdf

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