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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761275
Company: FRESENIUS KABI USA

Medication Guide

Products on BLA 761275

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761275

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/05/2024	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275Orig1s000Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761275Orig1s000Correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761275Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/2025	SUPPL-15	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761275s015lbl.pdf
12/13/2024	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761275Orig1s013ltr.pdf
12/03/2024	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761275Orig1s011ltr.pdf
02/28/2025	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761275s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761275Orig1s008ltr.pdf
05/12/2025	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761275s004,761449s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761275Orig1s004, 761449Orig1s001ltr.pdf
09/05/2024	SUPPL-1	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275Orig1s001lbl.pdf

Labels for BLA 761275

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2025	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761275s004,761449s001lbl.pdf
05/12/2025	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761275s004,761449s001lbl.pdf
05/12/2025	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761275s004,761449s001lbl.pdf
03/13/2025	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761275s015lbl.pdf
03/13/2025	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761275s015lbl.pdf
02/28/2025	SUPPL-8		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761275s008lbl.pdf
12/13/2024	SUPPL-13	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275s013lbl.pdf
12/13/2024	SUPPL-13	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275s013lbl.pdf
12/03/2024	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275s011lbl.pdf
12/03/2024	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275s011lbl.pdf
09/05/2024	SUPPL-1	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275Orig1s001lbl.pdf
03/05/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275Orig1s000Correctedlbl.pdf

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