Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103000
Company: ALLERGAN
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BOTOX | OnabotulinumtoxinA | 50 UNITS/VIAL | VIAL; SINGLE-USE | Prescription | None | No | No |
| BOTOX | OnabotulinumtoxinA | 100 UNITS/VIAL | VIAL; SINGLE-USE | Prescription | None | No | No |
| BOTOX | OnabotulinumtoxinA | 200 UNITS/VIAL | VIAL; SINGLE-USE | Prescription | None | No | No |
| BOTOX COSMETIC | OnabotulinumtoxinA | 50 UNITS/VIAL | VIAL; SINGLE-USE | Prescription | None | No | No |
| BOTOX COSMETIC | OnabotulinumtoxinA | 100 UNITS/VIAL | VIAL; SINGLE-USE | 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 |
|---|---|---|---|---|---|---|---|
| 12/09/1991 | ORIG-1 | Approval | N/A |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/10/2023 | SUPPL-5327 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103000s5327lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/103000Orig1s5327ltr.pdf | |
| 08/11/2023 | SUPPL-5325 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103000Orig1s5325Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/103000Orig1s5325Correctedltr.pdf | |
| 08/22/2022 | SUPPL-5322 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103000s5322lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/103000Orig1s5322ltr.pdf | |
| 07/28/2021 | SUPPL-5320 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103000s5320lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103000Orig1s5320ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/103000Orig1s5320.pdf | |
| 02/09/2021 | SUPPL-5318 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103000s5318lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103000Orig1s5318ltr.pdf | |
| 09/13/2020 | SUPPL-5317 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103000s5317lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103000Orig1s5317ltr.pdf | |
| 07/08/2020 | SUPPL-5315 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103000Orig1s5315lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103000Orig1s5315ltr.pdf | |
| 10/18/2019 | SUPPL-5310 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103000s5310lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103000Orig1s5310ltr.pdf | |
| 06/20/2019 | SUPPL-5309 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103000s5309lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103000Orig1s5309ltr.pdf | |
| 09/12/2018 | SUPPL-5308 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103000s5308lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103000Orig1s5308ltr.pdf | |
| 05/15/2018 | SUPPL-5307 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103000s5307lbl.pdf | |
| 05/16/2018 | SUPPL-5306 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103000s5306lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103000Orig1s5306ltr.pdf | |
| 10/02/2017 | SUPPL-5303 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103000s5303lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103000Orig1s5303ltr.pdf | |
| 04/20/2017 | SUPPL-5302 | Supplement |
Label (PDF)
Letter (PDF) |
Label for BOTOX | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103000s5302lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103000Orig1s5302ltr.pdf |
| 04/04/2017 | SUPPL-5298 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103000s5296s5297s5298lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103000s5298ltr.pdf | |
| 04/04/2017 | SUPPL-5297 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103000s5296s5297s5298lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103000Orig1s5296,s5297s5298ltr.pdf | |
| 04/04/2017 | SUPPL-5296 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103000s5296s5297s5298lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103000Orig1s5296,s5297s5298ltr.pdf | |
| 02/04/2016 | SUPPL-5294 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103000Orig1s5294ltr.pdf |
| 08/11/2015 | SUPPL-5292 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103000s5292lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103000Orig1s5292ltr.pdf | |
| 04/17/2015 | SUPPL-5282 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103000s5282lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103000Orig1s5282ltr.pdf | |
| 05/07/2014 | SUPPL-5280 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103000Orig1s5280ltr.pdf |
| 09/11/2013 | SUPPL-5260 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103000s5260lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103000Orig1s5260ltr.pdf | |
| 07/16/2012 | SUPPL-5256 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103000Orig1s5256ltr.pdf |
| 11/09/2012 | SUPPL-5253 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103000Orig1s5253lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103000Orig1s5253ltr.pdf | |
| 01/21/2016 | SUPPL-5252 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103000s5252lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103000Orig1s5252ltr.pdf | |
| 01/18/2013 | SUPPL-5251 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103000s5251lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103000Orig1s5251ltr.pdf | |
| 08/05/2015 | SUPPL-5244 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103000s5244lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103000Orig1s5244ltr.pdf | |
| 06/23/2011 | SUPPL-5236 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103000s5236lbl.pdf | |
| 08/24/2011 | SUPPL-5232 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103000s5232lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103000s5232ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2011/103000Orig1s5232.pdf | |
| 06/03/2010 | SUPPL-5219 | Supplement |
Label is not available on this site. |
||
| 10/15/2010 | SUPPL-5215 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103000s5215lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103000s5215ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2010/103000Orig1s5215.pdf | |
| 07/31/2009 | SUPPL-5210 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103000s5109s5210lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103000s5209s5210ltr.pdf | |
| 07/31/2009 | SUPPL-5209 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103000s5109s5210lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103000s5209s5210ltr.pdf | |
| 08/21/2009 | SUPPL-5197 | Supplement |
Label is not available on this site. |
||
| 03/09/2010 | SUPPL-5189 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103000s5189lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103000s5189ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2010/103000Orig1s5189.pdf | |
| 08/06/2008 | SUPPL-5184 | Supplement |
Label is not available on this site. |
||
| 03/21/2008 | SUPPL-5171 | Supplement |
Label is not available on this site. |
||
| 09/06/2007 | SUPPL-5165 | Supplement |
Label is not available on this site. |
||
| 08/23/2007 | SUPPL-5160 | Supplement |
Label is not available on this site. |
||
| 06/18/2007 | SUPPL-5159 | Supplement |
Label is not available on this site. |
||
| 04/26/2007 | SUPPL-5156 | Supplement |
Label is not available on this site. |
||
| 03/01/2007 | SUPPL-5151 | Supplement |
Label is not available on this site. |
||
| 09/28/2006 | SUPPL-5148 | Supplement |
Label is not available on this site. |
||
| 08/17/2006 | SUPPL-5144 | Supplement |
Label is not available on this site. |
||
| 03/26/2010 | SUPPL-5129 | Supplement |
Label is not available on this site. |
||
| 11/10/2005 | SUPPL-5122 | Supplement |
Label is not available on this site. |
||
| 03/26/2010 | SUPPL-5120 | Supplement |
Label is not available on this site. |
||
| 04/14/2005 | SUPPL-5101 | Supplement |
Label is not available on this site. |
||
| 03/11/2005 | SUPPL-5097 | Supplement |
Label is not available on this site. |
||
| 02/01/2005 | SUPPL-5092 | Supplement |
Label is not available on this site. |
||
| 07/19/2004 | SUPPL-5083 | Supplement |
Label is not available on this site. |
||
| 07/19/2004 | SUPPL-5050 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103000s5050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/103000_5050ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/103000Orig1s5050.pdf | |
| 04/12/2002 | SUPPL-5000 | Supplement |
Label (PDF)
Letter Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/botuall041202LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/botuall041202L.htm https://web.archive.org/web/20170113111252/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080509.htm | |
| 12/21/2000 | SUPPL-1004 | Supplement |
Letter
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/botaller122100L.htm https://web.archive.org/web/20090119110807/https://www.fda.gov/cder/biologics/products/botaller122100.htm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/11/2023 | SUPPL-5325 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103000Orig1s5325Correctedlbl.pdf | |
| 08/10/2023 | SUPPL-5327 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103000s5327lbl.pdf | |
| 08/22/2022 | SUPPL-5322 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103000s5322lbl.pdf | |
| 08/22/2022 | SUPPL-5322 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103000s5322lbl.pdf | |
| 07/28/2021 | SUPPL-5320 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103000s5320lbl.pdf | |
| 02/09/2021 | SUPPL-5318 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103000s5318lbl.pdf | |
| 09/13/2020 | SUPPL-5317 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103000s5317lbl.pdf | |
| 07/08/2020 | SUPPL-5315 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103000Orig1s5315lbl.pdf | |
| 10/18/2019 | SUPPL-5310 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103000s5310lbl.pdf | |
| 06/20/2019 | SUPPL-5309 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103000s5309lbl.pdf | |
| 09/12/2018 | SUPPL-5308 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103000s5308lbl.pdf | |
| 05/16/2018 | SUPPL-5306 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103000s5306lbl.pdf | |
| 05/15/2018 | SUPPL-5307 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103000s5307lbl.pdf | |
| 05/15/2018 | SUPPL-5307 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103000s5307lbl.pdf | |
| 10/02/2017 | SUPPL-5303 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103000s5303lbl.pdf | |
| 04/20/2017 | SUPPL-5302 | Labeling-Package Insert | Label (PDF) | Label for BOTOX | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103000s5302lbl.pdf |
| 04/04/2017 | SUPPL-5298 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103000s5296s5297s5298lbl.pdf | |
| 04/04/2017 | SUPPL-5297 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103000s5296s5297s5298lbl.pdf | |
| 04/04/2017 | SUPPL-5296 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103000s5296s5297s5298lbl.pdf | |
| 01/21/2016 | SUPPL-5252 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103000s5252lbl.pdf | |
| 08/11/2015 | SUPPL-5292 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103000s5292lbl.pdf | |
| 08/05/2015 | SUPPL-5244 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103000s5244lbl.pdf | |
| 04/17/2015 | SUPPL-5282 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103000s5282lbl.pdf | |
| 09/11/2013 | SUPPL-5260 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103000s5260lbl.pdf | |
| 01/18/2013 | SUPPL-5251 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103000s5251lbl.pdf | |
| 11/09/2012 | SUPPL-5253 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103000Orig1s5253lbl.pdf | |
| 08/24/2011 | SUPPL-5232 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103000s5232lbl.pdf | |
| 06/23/2011 | SUPPL-5236 | Supplement | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103000s5236lbl.pdf | |
| 10/15/2010 | SUPPL-5215 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103000s5215lbl.pdf | |
| 03/09/2010 | SUPPL-5189 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103000s5189lbl.pdf | |
| 07/31/2009 | SUPPL-5210 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103000s5109s5210lbl.pdf | |
| 07/31/2009 | SUPPL-5209 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103000s5109s5210lbl.pdf | |
| 07/19/2004 | SUPPL-5050 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103000s5050lbl.pdf | |
| 04/12/2002 | SUPPL-5000 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/botuall041202LB.pdf |