Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021859
Company: HALOZYME THERAP

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

Products on BLA 21859

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYLENEX RECOMBINANT	HYALURONIDASE RECOMBINANT HUMAN	150 UNITS/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Labels for BLA 021859

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/12/2024	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021859s031lbl.pdf
01/21/2016	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021859s023lbl.pdf
03/20/2012	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021859s015lbl.pdf
03/01/2012	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021859s009lbl.pdf
12/11/2009	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021859s006lbl.pdf
10/01/2008	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021859s005lbl.pdf
12/02/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021859lbl.pdf