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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761244
Company: BOEHRINGER INGELHEIM PHARMACEUTICALS INC

Medication Guide

Products on BLA 761244

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPEVIGO	SPESOLIMAB-SBZO	900MG	INJECTABLE;INTRAVENOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761244

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/01/2022	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761244s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761244Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761244Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/21/2025	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761244s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761244Orig1s007ltr.pdf
05/28/2025	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761244s004s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761244Orig1s004,s006ltr.pdf
05/28/2025	SUPPL-4	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761244Orig1s004,s006ltr.pdf
03/18/2024	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761244s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761244Orig1s003ltr.pdf

Labels for BLA 761244

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/21/2025	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761244s007lbl.pdf
05/28/2025	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761244s004s006lbl.pdf
05/28/2025	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761244s004s006lbl.pdf
03/18/2024	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761244s003lbl.pdf
09/01/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761244s000lbl.pdf

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