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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125360
Company: MERZ PHARMS

Medication Guide

Summary Review

Products on BLA 125360

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
Xeomin	incobotulinumtoxinA	50 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
Xeomin	incobotulinumtoxinA	100 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
Xeomin	incobotulinumtoxinA	200 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125360

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/2010	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125360lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125360s000,s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125360s0000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125360s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/08/2023	SUPPL-97	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125360s097lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125360Orig1s097ltr.pdf
08/13/2021	SUPPL-93	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125360s093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125360Orig1s093ltr.pdf
12/18/2020	SUPPL-92	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125360s086s092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125360Orig1s086, s092ltr.pdf
04/19/2021	SUPPL-91	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125360s087s088s089s090s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125360Orig1s087, s088, s089, s090, s091ltr.pdf
04/19/2021	SUPPL-90	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125360s087s088s089s090s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125360Orig1s087, s088, s089, s090, s091ltr.pdf
04/19/2021	SUPPL-89	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125360s087s088s089s090s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125360Orig1s087, s088, s089, s090, s091ltr.pdf
04/19/2021	SUPPL-88	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125360s087s088s089s090s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125360Orig1s087, s088, s089, s090, s091ltr.pdf
04/19/2021	SUPPL-87	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125360s087s088s089s090s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125360Orig1s087, s088, s089, s090, s091ltr.pdf
12/18/2020	SUPPL-86	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125360s086s092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125360Orig1s086, s092ltr.pdf
08/18/2020	SUPPL-78	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125360s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125360Orig1s078ltr.pdf
05/10/2019	SUPPL-74	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125360s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125360Orig1s074ltr.pdf
07/03/2018	SUPPL-73	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125360s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125360Orig1s073ltr.pdf
12/22/2015	SUPPL-67	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125360s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125360Orig1s067ltr.pdf
11/20/2015	SUPPL-66	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125360s066lbl.pdf
04/11/2013	SUPPL-45	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125360s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125360Orig1s045ltr.pdf
07/16/2012	SUPPL-40	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125360Orig1s040ltr.pdf
06/02/2011	SUPPL-12	Supplement		Label is not available on this site.
07/20/2011	SUPPL-7	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125360s007lbl.pdf
07/30/2010	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125360lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125360s000,s001ltr.pdf

Labels for BLA 125360

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/08/2023	SUPPL-97	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125360s097lbl.pdf
08/13/2021	SUPPL-93	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125360s093lbl.pdf
04/19/2021	SUPPL-91	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125360s087s088s089s090s091lbl.pdf
04/19/2021	SUPPL-90	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125360s087s088s089s090s091lbl.pdf
04/19/2021	SUPPL-89	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125360s087s088s089s090s091lbl.pdf
04/19/2021	SUPPL-88	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125360s087s088s089s090s091lbl.pdf
04/19/2021	SUPPL-87	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125360s087s088s089s090s091lbl.pdf
12/18/2020	SUPPL-92	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125360s086s092lbl.pdf
12/18/2020	SUPPL-86	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125360s086s092lbl.pdf
08/18/2020	SUPPL-78	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125360s078lbl.pdf
05/10/2019	SUPPL-74	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125360s074lbl.pdf
07/03/2018	SUPPL-73	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125360s073lbl.pdf
12/22/2015	SUPPL-67	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125360s067lbl.pdf
11/20/2015	SUPPL-66	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125360s066lbl.pdf
04/11/2013	SUPPL-45	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125360s045lbl.pdf
07/20/2011	SUPPL-7	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125360s007lbl.pdf
07/30/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125360lbl.pdf
07/30/2010	SUPPL-1	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125360lbl.pdf

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