Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103000
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
09/12/2018 SUPPL-5308 Supplement Letter (PDF)

Label is not available on this site.

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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103000s5307lbl.pdf
05/15/2018 SUPPL-5307 Labeling-Medication Guide 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

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