Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 761025
Company: BOEHRINGER INGELHEIM
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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