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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761347
Company: GENENTECH INC

Medication Guide

Products on BLA 761347

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TECENTRIQ HYBREZA	ATEZOLIZUMAB AND HYALURONIDASE-TQJS	125MG;2000UNITS PER ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761347

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/12/2024	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761347s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761347Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761347Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2025	SUPPL-5	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761347s005lbl.pdf
11/24/2025	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761347s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761347Orig1s004ltr.pdf
10/02/2025	SUPPL-3	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761347s003lbl.pdf
08/18/2025	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761347s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761347Orig1s002ltr.pdf

Labels for BLA 761347

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/24/2025	SUPPL-4	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761347s004lbl.pdf
11/17/2025	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761347s005lbl.pdf
10/02/2025	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761347s003lbl.pdf
08/18/2025	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761347s002lbl.pdf
09/12/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761347s000lbl.pdf

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