Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125327
Company: BTG INTERNATIONAL INC

Products on BLA 125327

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125327

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

Labels for BLA 125327

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