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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761149
Company: GENENTECH

Medication Guide

Products on BLA 761149

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENSPRYNG	SATRALIZUMAB	120MG/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761149

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/14/2020	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761149s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761149Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761149Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2026	SUPPL-7	Supplement		Label is not available on this site.
09/14/2022	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761149s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761149Orig1s005ltr.pdf
05/03/2021	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761149s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761149Orig1s002ltr.pdf

Labels for BLA 761149

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/14/2022	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761149s005lbl.pdf
09/14/2022	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761149s005lbl.pdf
05/03/2021	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761149s002lbl.pdf
08/14/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761149s000lbl.pdf

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