Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125338
Company: AUXILIUM PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XIAFLEX COLLAGENASE CLOSTRIDIUM HISTOLYTICUM 0.9MG SOLUTION; INJECTION Prescription None No 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
02/02/2010 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125338lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125338s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125338s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125338s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/26/2018 SUPPL-110 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125338Orig1s110ltr.pdf
06/06/2018 SUPPL-109 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125338s109lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125338Orig1s109ltr.pdf
09/19/2016 SUPPL-102 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125338s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125338Orig1s102ltr.pdf
11/28/2016 SUPPL-101 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125338Orig1s100,125338Orig1s101ltr.pdf
11/28/2016 SUPPL-100 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125338Orig1s100,125338Orig1s101ltr.pdf
05/15/2015 SUPPL-88 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125338Orig1s085,087,088ltr.pdf
05/15/2015 SUPPL-87 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125338Orig1s085,087,088ltr.pdf
05/15/2015 SUPPL-85 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125338Orig1s085,087,088ltr.pdf
10/20/2014 SUPPL-84 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125338s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125338Orig1s084ltr.pdf
12/06/2013 SUPPL-61 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125338s0061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125338Orig1s0061ltr.pdf
02/24/2012 SUPPL-40 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125338s0040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125338s0040ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/06/2018 SUPPL-109 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125338s109lbl.pdf
09/19/2016 SUPPL-102 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125338s102lbl.pdf
05/15/2015 SUPPL-88 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf
05/15/2015 SUPPL-87 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf
05/15/2015 SUPPL-85 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf
10/20/2014 SUPPL-84 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125338s084lbl.pdf
12/06/2013 SUPPL-61 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125338s0061lbl.pdf
02/24/2012 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125338s0040lbl.pdf
02/02/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125338lbl.pdf

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