Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 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 Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/02/2005 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021859lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021859ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021859_s000_HylenexTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/21/2016 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/28/2016 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/21/2016 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021859s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021859Orig1s023ltr.pdf
07/27/2015 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/17/2015 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/06/2014 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/16/2014 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/23/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/20/2012 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021859s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021859s015ltr.pdf
03/01/2012 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021859s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021859s009ltr.pdf
12/11/2009 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021859s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021859s006ltr.pdf
10/01/2008 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021859s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021859s005ltr.pdf
06/09/2006 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021859s002LTR.pdf
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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