Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 761025
Company: BOEHRINGER INGELHEIM

Products on BLA 761025

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRAXBIND	IDARUCIZUMAB	2.5G/50ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761025

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2015	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/761025Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/0761025Orig1000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/11/2022	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761025s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761025Orig1s013ltr.pdf
04/12/2018	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761025s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761025Orig1s002ltr.pdf

Labels for BLA 761025

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/11/2022	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761025s013lbl.pdf
04/12/2018	SUPPL-2	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761025s002lbl.pdf
10/16/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761025lbl.pdf