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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021859
Company: HALOZYME THERAP
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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
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