Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 019818
Company: LEADIANT BIOSCI INC

• This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 19818

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADAGEN	PEGADEMASE BOVINE	250 UNITS/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Labels for BLA 019818

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2014	SUPPL-53	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019818s053lbl.pdf
09/25/2008	SUPPL-42	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019818s042lbl.pdf
10/26/2007	SUPPL-34	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019818s034lbl.pdf