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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125274
Company: IPSEN BIOPHARM LTD

Medication Guide

Other Important Information from FDA

Summary Review

Products on BLA 125274

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125274

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

Labels for BLA 125274

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

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