Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125360
Company: MERZ PHARMS
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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