Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125293
Company: CREALTA PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KRYSTEXXA PEGLOTICASE 8MG INJECTABLE; INJECTION Prescription None TBD No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/14/2010 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125293s0000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125293s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125293s0000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125293Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/10/2017 SUPPL-90 Supplement

Label is not available on this site.

09/09/2016 SUPPL-89 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125293s089lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125293Orig1s089ltr.pdf
04/11/2016 SUPPL-86 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125293Orig1s086ltr.pdf
05/10/2016 SUPPL-85 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125293s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125293Orig1s085ltr.pdf
07/30/2015 SUPPL-83 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125293Orig1s083ltr.pdf
07/17/2015 SUPPL-81 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125293s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125293Orig1s081ltr.pdf
10/10/2013 SUPPL-60 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125293Orig1s060ltr.pdf
04/16/2012 SUPPL-40 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125293s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125293s034,s040ltr.pdf
04/16/2012 SUPPL-34 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125293s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125293s034,s040ltr.pdf
10/19/2010 SUPPL-1 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125293s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/09/2016 SUPPL-89 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125293s089lbl.pdf
05/10/2016 SUPPL-85 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125293s085lbl.pdf
07/17/2015 SUPPL-81 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125293s081lbl.pdf
04/16/2012 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125293s040lbl.pdf
04/16/2012 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125293s034lbl.pdf
09/14/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125293s0000lbl.pdf

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