Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125274
Company: IPSEN BIOPHARM LTD
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 |
---|---|---|---|---|---|
09/21/2023 | SUPPL-125 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125274s125lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125274Orig1s125ltr.pdf | |
01/12/2023 | SUPPL-123 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125274Orig1s123correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125274Orig1s123ltr.pdf | |
07/08/2020 | SUPPL-118 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125274Orig1s118lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125274Orig1s118ltr.pdf | |
09/25/2019 | SUPPL-115 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125274s115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125274Orig1s115ltr.pdf | |
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 |
---|---|---|---|---|---|
09/21/2023 | SUPPL-125 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125274s125lbl.pdf | |
01/12/2023 | SUPPL-123 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125274Orig1s123correctedlbl.pdf | |
07/08/2020 | SUPPL-118 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125274Orig1s118lbl.pdf | |
09/25/2019 | SUPPL-115 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125274s115lbl.pdf | |
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 |