Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125327
Company: BTG INTERNATIONAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VORAXAZE GLUCARPIDASE 1000 UNITS PER VIAL 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
01/17/2012 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125327lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125327s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125327Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/13/2019 SUPPL-64 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125327s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125327Orig1s064ltr.pdf
03/29/2013 SUPPL-20 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125327s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125327Orig1s020ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/13/2019 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125327s064lbl.pdf
03/29/2013 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125327s020lbl.pdf
01/17/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125327lbl.pdf

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