Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125338
Company: AUXILIUM PHARMS
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 |
---|---|---|---|---|---|
08/01/2022 | SUPPL-129 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125338s129lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125338Orig1s129ltr.pdf | |
11/02/2022 | SUPPL-128 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125338Orig1s128ltr.pdf |
06/09/2022 | SUPPL-127 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125338Orig1s127ltr.pdf |
01/11/2022 | SUPPL-121 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125338Orig1s121ltr.pdf |
08/19/2021 | SUPPL-117 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125338s117lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125338Orig1s117ltr.pdf | |
04/13/2021 | SUPPL-112 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125338s112lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125338Orig1s112ltr.pdf | |
07/12/2023 | SUPPL-111 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125338s111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125338Orig1s111ltr.pdf | |
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 |
---|---|---|---|---|---|
07/12/2023 | SUPPL-111 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125338s111lbl.pdf | |
08/01/2022 | SUPPL-129 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125338s129lbl.pdf | |
08/01/2022 | SUPPL-129 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125338s129lbl.pdf | |
08/19/2021 | SUPPL-117 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125338s117lbl.pdf | |
04/13/2021 | SUPPL-112 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125338s112lbl.pdf | |
04/13/2021 | SUPPL-112 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125338s112lbl.pdf | |
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 |