Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125274
Company: IPSEN BIOPHARM LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DYSPORT abobotulinumtoxinA 500 UNITS/VIAL INJECTABLE; INJECTION Prescription None No No
DYSPORT abobotulinumtoxinA 300 UNITS/VIAL INJECTABLE; 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
04/29/2009 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125274s0000s0001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125274s000,125274s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125274s000_dysport_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125274s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/05/2018 SUPPL-112 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125274s112lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125274Orig1s112ltr.pdf
06/14/2017 SUPPL-109 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125274s109lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125274Orig1s109ltr.pdf
12/09/2016 SUPPL-107 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125274s107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125274Orig1s107ltr.pdf
07/29/2016 SUPPL-105 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125274s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125274Orig1s105ltr.pdf
07/15/2015 SUPPL-102 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125274Orig1s102ltr.pdf
05/22/2012 SUPPL-52 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125274s0052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125274s0052ltr.pdf
09/27/2010 SUPPL-14 Supplement

Label is not available on this site.

04/29/2009 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125274s0000s0001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125274s000s001 ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125274s001_dysport_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125274Orig1s001SumR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/05/2018 SUPPL-112 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125274s112lbl.pdf
06/14/2017 SUPPL-109 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125274s109lbl.pdf
12/09/2016 SUPPL-107 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125274s107lbl.pdf
07/29/2016 SUPPL-105 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125274s105lbl.pdf
05/22/2012 SUPPL-52 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125274s0052lbl.pdf
04/29/2009 SUPPL-1 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125274s0000s0001lbl.pdf
04/29/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125274s0000s0001lbl.pdf

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