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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761354
Company: BIOGEN MA

Medication Guide

Products on BLA 761354

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOFIDENCE	TOCILIZUMAB-BAVI	80MG/4ML	INJECTABLE;INJECTION	Prescription	None	No	No
TOFIDENCE	TOCILIZUMAB-BAVI	200MG/10ML	INJECTABLE;INJECTION	Prescription	None	No	No
TOFIDENCE	TOCILIZUMAB-BAVI	400MG/20ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761354

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2023	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761354s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761354Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761354Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/03/2024	SUPPL-4	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761354Orig1s004ltr.pdf
07/22/2024	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761354s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761354Orig1s002ltr.pdf

Labels for BLA 761354

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/22/2024	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761354s002lbl.pdf
07/22/2024	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761354s002lbl.pdf
07/22/2024	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761354s002lbl.pdf
09/29/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761354s000lbl.pdf

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