Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125360
Company: MERZ PHARMS
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 |
| Xeomin | incobotulinumtoxinA | 200 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 |
|---|---|---|---|---|---|
| 07/05/2024 | SUPPL-99 | Supplement |
Label is not available on this site. |
||
| 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 |
| 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 |